Alvotech SA (ALVO) 2024 Q2 法說會逐字稿

完整原文

使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主

  • Benedikt Stefansson - Director of Investor Relations & Global Communications

    Benedikt Stefansson - Director of Investor Relations & Global Communications

  • Thank you and good morning or afternoon to everyone joining us on this call today. Yesterday evening, the company issued a press release that can be found on our Investor Portal investors.alvotech.com. The release reported financial results for the first half of 2024 and provides a business update.

    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。昨天晚上,該公司發布了一份新聞稿,您可以在我們的投資者入口網站 Investors.alvotech.com 上找到該新聞稿。新聞稿報告了 2024 年上半年的財務業績並提供了業務更新。

  • Additionally, presentation slides that cover our call today have been posted on our investor website, and you'll hear our speakers referring to the slide presentation during their comments. You'll find all material posted for this earnings call on our Investor Portal investors.alvotech.com, under the News and Events menu earnings calendar Q2 2024 earnings.

    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,您會聽到我們的演講者在評論中提到幻燈片演示。您可以在我們的投資者入口網站 Investors.alvotech.com 的「新聞和活動」菜單收益日曆 2024 年第二季度收益下找到本次收益電話會議發布的所有資料。

  • Please note that our presentation materials and some of our statements that we make today may include forward looking statements. 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. These risks and uncertainties could cause actual results to differ materially from forward-looking statements that are made.

    請注意,我們的簡報資料和我們今天所做的一些聲明可能包含前瞻性聲明。這些聲明不能確保未來的業績,並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。這些風險和不確定性可能導致實際結果與前瞻性陳述有重大差異。

  • With me on today's call are Robert Wessman, Chairman and Chief Executive Officer of Alvotech; Anil Okay, Chief Commercial Officer; Joel Morales, Chief Financial Officer; and Ming Li, Chief Strategy Officer.

    與我一起參加今天電話會議的有 Alvotech 董事長兼執行長 Robert Wessman;阿尼爾‧奧凱,首席商務官;喬爾‧莫拉萊斯,財務長;李明,首席策略長。

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

    說到這裡,我想把電話轉給羅伯特‧韋斯曼。羅伯特?

  • Robert Wessman - Executive Chairman of the Board, Chief Executive Officer, Founder

    Robert Wessman - Executive Chairman of the Board, Chief Executive Officer, Founder

  • Thank you, Benedikt, and greetings to everyone joining us on the call here today. It's a very exciting time at Alvotech. Alvotech is transitioning into global business, which we always intended when we started this venture 11 years ago. For the second quarter and first half of 2024, the company generated record results across the total revenues, revenues from product sales, milestone revenues and adjusted EBITDA. The total revenues for the first half of the year were $235.6 million, which represents an increase of over 10 times compared to the same period in 2023.

    謝謝貝內特,並向今天加入我們電話會議的所有人致以問候。這是 Alvotech 非常令人興奮的時刻。Alvotech 正在向全球業務轉型,這是我們 11 年前創辦這家企業時一直希望實現的目標。2024 年第二季和上半年,該公司在總收入、產品銷售收入、里程碑收入和調整後 EBITDA 方面均創下了創紀錄的業績。上半年總營收為2.356億美元,較2023年同期成長逾10倍。

  • Our first half results were driven mainly by the second quarter performance where 84% of the revenues for the period were generated. This enabled the company to deliver positive EBITDA, both for the second quarter of around $102 million and the first half of the year of around $63.5 million. This is a result which we are all very proud of here at Alvotech.

    我們上半年的業績主要受到第二季業績的推動,該期間 84% 的營收來自第二季。這使得該公司能夠實現正的 EBITDA,第二季約為 1.02 億美元,上半年約為 6,350 萬美元。這是 Alvotech 所有人都感到非常自豪的結果。

  • Contribution to our growth and profitability came from multiple sources, including product revenues from Ex-US Stelara and US biosimilar to Humira from both private label and branded channels. At the same time, we're seeing our focus on cost efficiencies bearing a fruit as we scale up production volumes and further utilize our facility.

    對我們的成長和獲利能力的貢獻來自多個來源,包括來自美國以外的 Stelara 的產品收入以及來自自有品牌和品牌管道的 Humira 生物仿製藥的美國生物仿製藥收入。同時,隨著我們擴大產量並進一步利用我們的設施,我們對成本效率的關注正在結出碩果。

  • On our last earning call, we noted that we had received binding purchase order of approximately 1 million units for our biosimilar to Humira in the US market. We also noted that we would be supplying that inventory throughout the calendar year 2024. I'm very pleased to update that our current 2024 order book for the US market has now reached approximately 1.3 million units, which is a substantial increase from our previous call.

    在我們上次的財報電話會議上,我們注意到我們在美國市場收到了約 100 萬份 Humira 生物相似藥的具有約束力的採購訂單。我們也指出,我們將在 2024 年全年供該庫存。我很高興地宣布,我們目前在美國市場的 2024 年訂單量現已達到約 130 萬台,比我們先前的預測大幅增加。

  • Our result in the second quarter set the record for the company when it comes to revenues and EBITDA, which is in line with our expectations. As planned, Alvotech delivered approximately 20% of the US 1.3 million unit order book during the first half of the year.

    我們第二季的業績在營收和 EBITDA 方面創下了公司的記錄,這符合我們的預期。按照計劃,Alvotech 在今年上半年交付了美國 130 萬台訂單中的約 20%。

  • We expect to deliver approximately 80% of the order book or over 1 million units in the second half. We expect that our third quarter will show a strong volume growth over the second one and fourth quarter to be by far the strongest quarter of the year in sold volumes. We have scaled up our production capacity at Alvotech and the company is in a strong position to deliver towards our order book going forward.

    我們預計下半年將交付約 80% 的訂單,超過 100 萬台。我們預計第三季的銷售量將比第二季和第四季強勁成長,成為迄今為止銷量最強勁的季度。我們已經擴大了 Alvotech 的生產能力,該公司在未來交付訂單方面處於有利地位。

  • In addition, we are seeing strong demand for our biosimilar to Humira in US for the first quarter of 2025. At the same time, we are working with our partners to build plans for the full year of 2025, both for biosimilar to Humira and Stelara.

    此外,我們預計 2025 年第一季美國對 Humira 生物相似藥的需求強勁。同時,我們正在與合作夥伴合作制定 2025 年全年計劃,包括 Humira 和 Stelara 的生物相似藥。

  • In addition to the product revenue, we continue to show a great progress of our pipeline and new business agreements for our portfolio. This progress allowed for record revenues and milestones for the quarter, which we guided to on our first quarter call. The milestone revenues not only contribute to the current performance, but also serve as an indicator for future success as the products and partnerships come online. It's important to know that the result is simply a function of the consistent execution that you have seen from Alvotech throughout this critical year.

    除了產品收入外,我們還繼續展示我們的產品線和產品組合的新業務協議的巨大進展。這一進展使得本季度的收入和里程碑達到了創紀錄的水平,這是我們在第一季電話會議上所指導的。里程碑式的收入不僅有助於當前業績,而且隨著產品和合作夥伴關係的上線,也可作為未來成功的指標。重要的是要知道,結果只是您在整個關鍵的一年中從 Alvotech 看到的一致執行的結果。

  • On the next slide of the presentation, you can see the steady accomplishments that we have been occurring throughout the year. This includes regulatory approvals, commercial launches, strategic collaborations, pipeline progress and refinancing of the company that Joel Morales will be discussing during his remarks.

    在簡報的下一張投影片中,您可以看到我們全年取得的穩定成就。這包括喬爾·莫拉萊斯將在演講中討論的監管批准、商業發布、戰略合作、管道進展和公司再融資。

  • Looking forward to the rest of the year, we expect continued execution on both commercial and R&D fronts and we will be providing relevant updates as they occur.

    展望今年剩餘時間,我們預計商業和研發方面將繼續執行,並且我們將在發生時提供相關更新。

  • Moving to the next slides, I would like to mention some of my thoughts on Alvotech position today. When the IT of Alvotech was created just over a decade ago, there were two fundamental concepts that we believe are critically important. The first was a global portfolio approach to biosimilars. We thought a broad portfolio of global biosimilars would limit overall risk through diversification, but also improve the commercial opportunities for the products that we launched.

    轉到下一張投影片,我想談談我今天對 Alvotech 立場的一些想法。當 Alvotech 的 IT 部門在十多年前創建時,我們認為有兩個至關重要的基本概念。第一個是生物相似藥的全球投資組合方法。我們認為廣泛的全球生物相似藥組合將透過多樣化來限制整體風險,同時也改善我們推出的產品的商業機會。

  • That portfolio expansions and diversification is well underway today. We now have 47 unique launches across two biosimilars in many global markets and we are in the very early stage of this growth. Before end of the year 2025, we expect to have at least 70 global launches covering our first two products and that includes the launch of SELARSDI, our biosimilar to Stelara in the US markets.

    如今,投資組合擴張和多元化正在順利進行。目前,我們在全球許多市場上推出了 47 種獨特的生物相似藥,涉及兩種生物相似藥,我們正處於這一成長的早期階段。在 2025 年底之前,我們預計將在全球推出至少 70 種產品,涵蓋我們的前兩種產品,其中包括在美國市場推出我們的 Stelara 生物相似藥 SELARSDI。

  • Furthermore, we are on the track to submit three biosimilar applications in major market by end of 2024 with anticipated revenues from specific markets and molecules starting as early as end of 2025. We estimate that it takes two to four years for any given launch, regardless of size to peak in revenue. The second fundamental part of our concept was to ensure that we built a platform that would only focus on developing and manufacturing of biosimilars. This means that we are a pure play biosimilar company.

    此外,我們預計在 2024 年底前在主要市場提交三種生物相似藥申請,預計最早於 2025 年底開始從特定市場和分子獲得收入。我們估計,無論規模大小,任何特定的發布都需要兩到四年才能達到收入高峰。我們概念的第二個基本部分是確保我們建立一個僅專注於生物相似藥的開發和製造的平台。這意味著我們是一家純粹的生物相似藥公司。

  • Today, we have built a world class facility where we can develop new biosimilars successfully under the fast rates. At the same time, we have a full control over the supply chain and the quality. And simply by using our development and production platform, we can leverage what we have built to drive future earnings.

    今天,我們已經建立了世界一流的設施,可以快速成功地開發新的生物相似藥。同時,我們對供應鏈和品質有完全的控制。只需使用我們的開發和生產平台,我們就可以利用我們所建立的平台來推動未來的獲利。

  • Between 2023 and this year, we are expecting to expand production volumes by more than threefold. We are also expecting to submit three new applications, which would be a record for the company. And we are able to do this with headcount remaining mostly flat year-on-year. We believe this leverage can continue as we continue to launch new products into new markets in the future.

    從 2023 年到今年,我們預計產量將擴大三倍以上。我們還預計將提交三份新申請,這將創下該公司的記錄。我們能夠在員工人數與去年同期基本持平的情況下做到這一點。我們相信,隨著我們未來繼續向新市場推出新產品,這種槓桿作用可以持續下去。

  • I would like to thank all of you for joining us here today. And at the same time, I would like to extend my gratitude to the Alvotech team for their relentless effort in driving our company's success.

    我要感謝大家今天來到這裡。同時,我要感謝 Alvotech 團隊為推動我們公司的成功所做的不懈努力。

  • And with that, I would like to pass the presentation over to Anil Okay, our Chief Commercial Officer to cover our pipeline and provide commercial update. Over to you, Anil.

    至此,我想將簡報交給我們的商務長阿尼爾·奧凱,以介紹我們的產品線並提供商業更新。交給你了,阿尼爾。

  • Anil Okay - Board Member

    Anil Okay - Board Member

  • Thank you, Robert. I will start today with an update on biosimilar Humira in the US. As a reminder, we are addressing both channels for biosimilar Humira, which includes private label and also formulary business. With the private label, as you may know, we are partnered with Quallent, which is the private label for the Cigna Group, a leading player in the US market. Through the company's specialty pharmacy, Accredo, the group services more than 100,000 patients that currently use Humira or one of its biosimilars.

    謝謝你,羅伯特。今天我將首先介紹美國生物相似藥 Humira 的最新情況。提醒一下,我們正在解決生物相似藥 Humira 的兩個管道,其中包括自有品牌和處方業務。如您所知,我們與自有品牌合作,Quallent 是美國市場領導者 Cigna Group 的自有品牌。透過該公司的專業藥房 Accredo,該集團為目前使用 Humira 或其生物仿製藥之一的超過 100,000 名患者提供服務。

  • As a reminder, our BLA was approved in February 2024 and the partnership was formally announced at the end of April. However, the actual launch did not occur until June with the shipments occurring downstream later in that month. Despite the recency of the launch, we are seeing good traction in the market.

    提醒一下,我們的 BLA 於 2024 年 2 月獲得批准,合作夥伴關係於 4 月底正式宣布。然而,直到六月才真正啟動,並在當月晚些時候向下游發貨。儘管推出時間不久,但我們看到了市場的良好吸引力。

  • In a recent call by the Cigna Group, they noted that after only five weeks, they are seeing approximately 20% of their book transitioning to biosimilars. The progress we are seeing with CVS Caremark within the Humira space and the developments within the Cigna Group, which collectively represents the two largest payers in the US, along with various public statements made by others, reinforce our confidence that the adoption of pharmacy benefit biosimilars is accelerating rapidly in the world's largest market.

    在 Cigna Group 最近的一次電話會議中,他們指出,僅五週後,他們就看到大約 20% 的書籍轉向生物相似藥。我們看到CVS Caremark 在Humira 領域的進展以及Cigna 集團(共同代表美國最大的兩個付款人)內部的發展,以及其他人發表的各種公開聲明,增強了我們的信心,即採用藥房有利於生物相似藥在全球最大的市場中正在迅速加速。

  • We believe we are well positioned to capitalize on this momentum as we expect to have multiple pharmacy benefit products on the market by year end 2025. In addition to the private label space, we are also addressing the formulary side of the business through the brand SIMLANDI, an interchangeable, high concentration biosimilar version of Humira. As a reminder, we are the first interchangeable, high concentration biosimilar version of Humira and we have an exclusivity on our interchangeability up until May 2025.

    我們相信,我們已做好充分利用這一勢頭的準備,因為我們預計到 2025 年底,市場上將有多種藥品福利產品。除了自有品牌領域外,我們還透過 SIMLANDI 品牌解決業務的處方方面問題,SIMLANDI 是 Humira 的可互換、高濃度生物仿製藥版本。提醒一下,我們是 Humira 的第一個可互換的高濃度生物仿製藥版本,並且我們在 2025 年 5 月之前擁有互換性的排他性。

  • In July, formulary changes occurred in various parts of the market and we are pleased that SIMLANDI is now listed as preferred on Express Scripts, CarelonRx, Navitus and Blue Cross Blue Shield of Massachusetts and Louisiana. We expect this to evolve over time in a favorable manner and we anticipate further coverage as we move into 2025. We are very pleased with the progress of our partner Teva has made thus far.

    7 月份,市場各地的處方發生了變化,我們很高興 SIMLANDI 現已被 Express Scripts、CarelonRx、Navitus 以及馬薩諸塞州和路易斯安那州的 Blue Cross Blue Shield 列為首選藥物。我們預計這種情況會隨著時間的推移以有利的方式發展,並預計隨著 2025 年的到來,覆蓋範圍將進一步擴大。我們對合作夥伴 Teva 迄今為止所取得的進展感到非常高興。

  • Teva is the ideal partner for us due to their extensive presence and expertise in the US specialty channels coupled with their unwavering commitment to advancing biosimilars. Teva is not only our partner on SIMLANDI, but also our partner on SELARSDI, our approved biosimilar to Stelara. AVT06 are proposed biosimilar to Eylea. AVT29 are proposed biosimilar to high dose Eylea and AVT05 are biosimilar candidate to Simponi, among others. This is a very strategic partnership for multiple products.

    Teva 是我們理想的合作夥伴,因為他們在美國專業通路中擁有廣泛的影響力和專業知識,並且堅定不移地致力於推進生物仿製藥的發展。Teva 不僅是我們在 SIMLANDI 上的合作夥伴,也是我們在 SELARSDI(我們已批准的 Stelara 生物相似藥)上的合作夥伴。AVT06 被提議為 Eylea 的生物相似藥。AVT29 被提議為高劑量 Eylea 的生物相似藥,AVT05 是 Simponi 等的候選生物相似藥。這是多種產品的非常策略性的合作夥伴關係。

  • We look forward to progress on all fronts as the partnership progresses across both channels for AVT02 in the US. And as Robert noted earlier, our order book has reached approximately 1.3 million units for 2024 alone and only for the US market. We are happy with the launch thus far and plan to deliver over 80% of our current order book in the second half of the year.

    隨著 AVT02 在美國的兩個管道的合作夥伴關係的進展,我們期待在各個方面取得進展。正如 Robert 之前指出的,光是 2024 年我們的訂單量就達到了約 130 萬台,而且僅針對美國市場。我們對迄今為止的發布感到滿意,並計劃在今年下半年交付超過 80% 的當前訂單。

  • Several key variations filed open approval of SIMLANDI have been approved by the FDA in late June, which allows us to easily scale up and automate key downstream activities that will start flowing through in Q3 and expand in the fourth quarter. We will carry that pace into 2025 and we look forward to providing further updates as the year progresses.

    SIMLANDI 的幾個關鍵變體已於 6 月下旬獲得 FDA 批准,這使我們能夠輕鬆擴大規模並實現關鍵下游活動的自動化,這些活動將在第三季度開始流通並在第四季度擴大。我們將在 2025 年繼續保持這一步伐,並期待隨著時間的推移提供進一步的更新。

  • We are also seeing the order book coming in well for the start of next year as mentioned earlier and expect changes in the coverage environment to accelerate going into 2025. As a business to business company, we have good visibility during our binding order period, which is five to six months in advance and we receive rolling forecasts from our partners beyond that.

    如同前面所提到的,我們也看到明年年初的訂單量良好,並預計覆蓋環境的變化將加速進入 2025 年。作為一家企業對企業的公司,我們在具有約束力的訂單期內(提前五到六個月)具有良好的可見性,並且在此之後我們會收到合作夥伴的滾動預測。

  • Further, as the B2B firm, it is important to note that we recognize revenue, open delivery of our product to the partners. This dynamic coupled with our expectations for market development, strengthens our confidence in both our 2024 guidance and our 2025 revenue projections of $600 million to $800 million.

    此外,作為 B2B 公司,值得注意的是,我們確認收入,向合作夥伴公開交付我們的產品。這種動態加上我們對市場發展的預期,增強了我們對 2024 年指引和 2025 年 6 億至 8 億美元收入預測的信心。

  • For the next topic, I will discuss our global launches of our biosimilar to Stelara. Earlier this year, we launched in Canada under the brand name Jamteki as the first biosimilar of Stelara into a very limited competition through our partner, Jamp Pharma and under their BIOJAMP umbrella, which now markets both biosimilars approved under our partnership.

    對於下一個主題,我將討論我們在全球推出的 Stelara 生物相似藥。今年早些時候,我們在加拿大推出了Jamteki 品牌,作為Stelara 的第一個生物仿製藥,透過我們的合作夥伴Jamp Pharma 並在他們的BIOJAMP 保護傘下進行了非常有限的競爭,該公司現在銷售在我們的合作夥伴關係下批准的兩種生物相似藥。

  • Shortly after the Canadian launch and through our partner Fuji Pharma, we launched AVT04 in Japan as a first biosimilar to Stelara and we see no competition on the horizon in this market.

    在加拿大上市後不久,我們透過我們的合作夥伴富士製藥在日本推出了 AVT04,作為 Stelara 的第一個生物仿製藥,我們認為該市場不會出現競爭。

  • And most recently, our partner STADA launched Uzpruvo in countries across Europe as the first of its kind in the market. These launches are still in the early days, but even with that said, we have received replenishment orders from all three partners. We are very proud in our ability to execute numerous first in market launches across multiple jurisdictions, all within a five months period. This achievement showcases our production capabilities and operational excellence that will pave the way for a successful US launch in February 2025.

    最近,我們的合作夥伴 STADA 在歐洲各國推出了 Uzpruvo,這是市場上的首個此類產品。這些產品的推出仍處於早期階段,但即便如此,我們還是收到了來自所有三個合作夥伴的補貨訂單。我們非常自豪能夠在五個月的時間內在多個司法管轄區執行多項首次市場發布。這項成就展現了我們的生產能力和卓越營運能力,將為 2025 年 2 月在美國的成功推出鋪平道路。

  • The global launches of our biosimilar to Stelara represent a multi-product and global focus in this rapidly evolving space. We are quickly diversifying our revenue base and we should see that diversification continue to occur as these launches mature and new launches come to the market, including our expected launch of SELARSDI in the US within the next six months.

    我們在全球推出的 Stelara 生物相似藥代表了這個快速發展的領域的多產品和全球焦點。我們正在迅速實現收入基礎的多元化,隨著這些產品的成熟和新產品的上市,包括我們預計在未來六個月內在美國推出的 SELARSDI,我們應該會看到這種多元化繼續發生。

  • We are very excited about the upcoming US Stelara biosimilar launch and we feel we are more than well positioned to be a leader in that market. We have received our approval for SELARSDI in April of this year, which provides ample time to prepare for launch in February of 2025.

    我們對即將在美國推出的 Stelara 生物相似藥感到非常興奮,我們認為我們完全有能力成為該市場的領導者。我們在今年 4 月收到了 SELARSDI 的批准,這為 2025 年 2 月的啟動提供了充足的時間。

  • Moving to the next two slides, I would like to conclude my portion of the presentation with updates on our portfolio. As our commercial footprint continues to grow, it remains crucial to sustain our long-term growth by staying at the forefront of biosimilar R&D. We believe that our comprehensive R&D platform, which encompasses a full range of capabilities and a unique approach, sets Alvotech apart in the market.

    轉到接下來的兩張投影片,我想用我們的作品集的更新來結束我的簡報部分。隨著我們的商業足跡不斷增長,透過維持生物相似藥研發的前沿來維持我們的長期成長仍然至關重要。我們相信,我們的綜合研發平台涵蓋全方位的能力和獨特的方法,使 Alvotech 在市場上脫穎而出。

  • Our next product in the pipeline is Eylea, Regeneron's blockbuster biologic that targets retinal diseases. In this market, we aim to launch both the original vial presentation, as well as a pre-filled syringe that is better received by physicians that have to administer the product themselves. We are very pleased to have now partnered the product with Advanz Pharma in Europe, which was announced this June.

    我們正在研發的下一個產品是 Eylea,這是 Regeneron 的針對視網膜疾病的重磅生物製劑。在這個市場上,我們的目標是推出原創的小瓶外觀,以及更受需要自行管理產品的醫生歡迎的預填充注射器。我們很高興現在與歐洲的 Advanz Pharma 合作推出該產品,這項合作於今年 6 月宣布。

  • Just yesterday, the company announced that the European Medicines Agency has accepted our AVT06 submission for review. This marks the third biosimilar candidate that Alvotech has submitted in a major market. It is important to recognize that announcements regarding submissions are made open filing acceptance, which can vary in timing after the initial filing. We look forward to providing updates as the program continues to progress in Europe and other markets, including US.

    就在昨天,該公司宣布歐洲藥品管理局已接受我們的 AVT06 提交資料進行審查。這標誌著 Alvotech 在主要市場提交的第三種生物相似藥候選藥物。重要的是要認識到,有關提交的公告是公開提交接受的,在初次提交後的時間可能會有所不同。隨著該計劃在歐洲和包括美國在內的其他市場繼續取得進展,我們期待提供最新資訊。

  • The next product to discuss is the high dose version of Eylea. High dose Eylea, which offers less frequent dosing, was launched by the originator in August 2023 in the US. The conversion of the market has been steady, and based on recent quarter results for Regeneron, it appears to have captured just under 20% of sales. We aim to be the first high dose Eylea biosimilar to the global markets, which would represent tremendous opportunity for Alvotech and its alliance partners globally.

    下一個要討論的產品是 Eylea 的高劑量版本。高劑量 Eylea 的給藥頻率較低,由創辦人於 2023 年 8 月在美國推出。市場轉換一直穩定,根據 Regeneron 最近一個季度的業績,它似乎佔據了略低於 20% 的銷售額。我們的目標是成為全球市場上第一個高劑量 Eylea 生物相似藥,這將為 Alvotech 及其全球聯盟合作夥伴帶來巨大的機會。

  • AVT29 is also part of our collaboration with Teva and Advanz. We have developed a formulation and are currently manufacturing scale up batches which we believe is an advanced position. We believe this is a direct result from starting our development program well in advance of the originator launch. As we continue the development, we look forward to providing further updates on this exciting program.

    AVT29 也是我們與 Teva 和 Advanz 合作的一部分。我們已經開發了一種配方,目前正在擴大批量生產,我們認為這是一個先進的地位。我們相信這是在原創者發布之前就開始我們的開發計劃的直接結果。隨著我們繼續開發,我們期待提供有關這個令人興奮的計劃的進一步更新。

  • The next opportunity I would like to discuss is our proposed biosimilar to Simponi and Simponi Aria. Simponi has been developed using the same platform as our Stelara biosimilar, which utilizes an alternative cell line called SP20 and is manufactured using a perfusion manufacturing process.

    我想討論的下一個機會是我們提議的 Simponi 和 Simponi Aria 生物相似藥。Simponi 是使用與我們的 Stelara 生物仿製藥相同的平台開發的,該生物仿製藥利用了一種名為 SP20 的替代細胞系,並採用灌注製造工藝進行製造。

  • We believe that our perfusion platform, in which we have invested significantly, has facilitated the development of both programs. We also see that the complexity of development has potentially contributed to lower competition in the Stelara market compared to Humira and even more so for Simponi. In fact, only one other company has a known clinical study for a Simponi biosimilar candidate. This competitive landscape presents a unique opportunity for the company and our partners, including Teva in the US, Advanz in Europe and our global partners in rest of the world.

    我們相信,我們投入了大量資金的灌注平台促進了這兩個項目的發展。我們還發現,與 Humira 相比,開發的複雜性可能導致 Stelara 市場的競爭較低,對於 Simponi 來說更是如此。事實上,只有另一家公司對 Simponi 生物相似藥候選藥物進行了已知的臨床研究。這種競爭格局為公司和我們的合作夥伴(包括美國的 Teva、歐洲的 Advanz 以及我們在世界其他地區的全球合作夥伴)提供了獨特的機會。

  • We aim to be the first to market Stelara biosimilar in global markets and expect very limited competition, if any. Our filing remains on track for later this year and we are proud to claim that we are the only company that has developed successfully biosimilars to Humira and Stelara and have a very advanced candidate for a biosimilar to Simponi in our portfolio. We believe that is a very powerful message that both our partners and Alvotech can use in the market.

    我們的目標是成為第一個在全球市場上銷售 Stelara 生物相似藥的公司,並預計競爭(如果有的話)非常有限。我們的申請仍將在今年稍後進行,我們很自豪地宣稱,我們是唯一一家成功開發出Humira 和Stelara 生物仿製藥的公司,並且在我們的產品組合中擁有非常先進的Simponi 生物仿製藥候選藥物。我們相信這是一個非常有力的訊息,我們的合作夥伴和 Alvotech 都可以在市場上使用。

  • Our next portfolio product that we expect to submit this year is AVT03, our biosimilar to both Prolia and Xgeva. We are pleased to have recently partnered with Dr. Reddy's Laboratories through an agreement finalized in May of this year. The agreement covers both the US and Europe with European rights granted on a semi exclusive basis. In June, we announced that we have expanded our partnership with STADA in Europe with AVT03.

    我們預計今年提交的下一個產品組合是 AVT03,它是 Prolia 和 Xgeva 的生物相似藥。我們很高興最近與 Reddy 博士實驗室透過今年 5 月敲定的協議進行了合作。該協議涵蓋美國和歐洲,並以半排他性方式授予歐洲權利。6 月,我們宣布透過 AVT03 擴大了與歐洲 STADA 的合作夥伴關係。

  • We are thrilled to strengthen our collaboration with such a well-respected leader in that market and showcase our partnership mindset to expand more products with our existing partners and adding new ones as needed. We have passed all of the requisite studies against both originator products and look forward to providing updates in the near term.

    我們很高興能加強與該市場如此受人尊敬的領導者的合作,並展示我們的合作夥伴心態,與我們現有的合作夥伴一起擴展更多產品,並根據需要添加新產品。我們已經通過了針對這兩種原創產品的所有必要研究,並期待在短期內提供更新。

  • AVT23 is a biosimilar to Xolair, which we have licensed and are supporting development in conjunction with Kashiv BioSciences. This program is in partnership with Advanz, one of our key European partner with plans for Advanz to market it across Europe.

    AVT23 是 Xolair 的生物相似藥,我們已獲得該藥物的許可,並支持與 Kashiv BioSciences 共同開發。該計劃是與 Advanz 合作的,Advanz 是我們在歐洲的主要合作夥伴之一,Advanz 計劃在整個歐洲銷售該產品。

  • The proposed biosimilar continues to make significant progress with the recent completion of patient enrollment for the clinical study, making an important milestone. Filing time is near term, however, we have not commented yet on exact timing. What is also very appealing in that market, omalizumab remains to be also a low competition market which will benefit both Alvotech and Advanz at the time of launch.

    隨著最近完成臨床研究的患者入組,擬議的生物相似藥繼續取得重大進展,成為一個重要的里程碑。提交時間即將到來,但我們尚未對確切時間發表評論。該市場也非常有吸引力,奧馬珠單抗仍然是一個低競爭市場,這將使 Alvotech 和 Advanz 在上市時受益。

  • Our next pipeline product is a proposed biosimilar to Entyvio. The product is currently at $5.6 billion in total market size and we believe there is significant growth opportunity for the molecule until LOE. Our program is progressing nicely, and we expect to start our patient study in September this year.

    我們的下一個管道產品是擬議的 Entyvio 生物相似藥。該產品目前的總市場規模為 56 億美元,我們相信該分子在 LOE 之前存在巨大的成長機會。我們的專案進展順利,預計今年 9 月開始患者研究。

  • One of the exciting aspects in this market is, we see very few initiated studies and we believe that we could be in a poor position in the development of an Entyvio biosimilar. We also have some undisclosed differentiation aspects in our development. We look forward to providing updates as they occur in our program.

    這個市場令人興奮的方面之一是,我們看到很少有啟動研究,我們相信我們在 Entyvio 生物相似藥的開發中可能處於不利地位。我們的發展中還有一些未公開的差異化面向。我們期待在我們的計劃中發生更新時提供更新。

  • And finally, we are also developing a biosimilar to Keytruda, which is, of course, is Merck’s blockbuster oncology product, which has now surpassed Humira as the highest-grossing pharma product on record. While in an earlier stage than our previously discussed pipeline, we are making progress and expect at-scale production to occur in 2025 and are also targeting clinical study start to occur sometime next year. We continue the active discussions with multiple parties on partnership and are excited to share updates once deals become finalized.

    最後,我們也正在開發 Keytruda 的生物相似藥,當然,它是默克的重磅腫瘤產品,現已超越修美樂(Humira),成為有史以來收入最高的製藥產品。雖然處於我們之前討論的管道的早期階段,但我們正在取得進展,預計將在 2025 年進行大規模生產,並且還計劃在明年某個時候開始進行臨床研究。我們繼續與多方就合作關係進行積極討論,並很高興在交易敲定後分享最新動態。

  • Outside of Keytruda, it is worth mentioning that we have three more development programs in early stages of development, and we also maintain a robust cell line development plan to ensure we can move forward on new products quickly and efficiently.

    除了Keytruda之外,值得一提的是,我們還有三個處於開發早期階段的開發項目,我們還保持著穩健的細胞系開發計劃,以確保我們能夠快速有效地推進新產品的開發。

  • And with that, I will turn the presentation over to Joel Morales, our Chief Financial Officer. Joel?

    接下來,我將把簡報交給我們的財務長喬爾‧莫拉萊斯 (Joel Morales)。喬爾?

  • Joel Morales - Chief Financial Officer

    Joel Morales - Chief Financial Officer

  • Thank you, Anil. Firstly, I would like to take a moment to reflect on last month's announcement regarding the refinancing of our outstanding debt. We announced that we successfully closed on a senior secured first lien term loan facility for $965 million. We're transitioning from a debt pool with fixed and higher levels of interest to a SOFR based facility.

    謝謝你,阿尼爾。首先,我想花點時間回顧一下上個月有關我們未償債務再融資的公告。我們宣布,我們成功完成了 9.65 億美元的優先擔保第一留置權定期貸款融資。我們正在從固定且較高利息水準的債務池過渡到基於 SOFR 的設施。

  • At current SOFR levels, we are able to reduce the cost of capital by approximately 100 basis points with the opportunity for further reductions as the macro environment improves over time. The refinancing of our existing outstanding debt obligations has improved our debt maturity profile by extending near-term maturities originally due starting in mid-2025 out to 2029. Additionally, the facility has favorable call features which provide us with future optionality as we continue to drive profitability, diversification, and cash flows over the near term.

    在目前的 SOFR 水準上,我們能夠將資本成本降低約 100 個基點,並且隨著宏觀環境隨著時間的推移而改善,還有機會進一步降低。我們現有未償債務的再融資將原定於 2025 年中期到期的近期到期期限延長至 2029 年,從而改善了我們的債務到期狀況。此外,該工具具有有利的看漲期權功能,為我們提供了未來的選擇權,因為我們在短期內繼續推動盈利能力、多元化和現金流。

  • Also, in conjunction with this refinancing, holders of the majority of convertible bonds exercised their right to convert into ordinary shares on July 1, 2024. The balance of any remaining convertible bonds was redeemed by Alvotech with the proceeds from this refinancing.

    此外,結合本次再融資,大多數可轉換債券的持有人於2024年7月1日行使其轉換為普通股的權利。Alvotech 以本次再融資的收益贖回了任何剩餘可轉換債券的餘額。

  • Lastly, the net impact of this transaction in July added approximately $142 million of net cash to our balance sheet and simplified our borrowing structure to only the term loan facility, the mortgage on our manufacturing facility in Iceland, and some equipment financing. All of these instruments are set to mature commencing in June 2029 or beyond.

    最後,7 月這項交易的淨影響為我們的資產負債表增加了約 1.42 億美元的淨現金,並將我們的借款結構簡化為僅定期貸款、冰島製造工廠的抵押貸款和一些設備融資。所有這些工具都將於 2029 年 6 月或更長時間開始成熟。

  • As our capital structure continues to streamline, our objective is to keep our shareholders and investors focused on the fundamental value of our business and on the future growth trajectory we are poised to deliver on.

    隨著我們的資本結構不斷精簡,我們的目標是讓股東和投資者專注於我們業務的基本價值以及我們準備實現的未來成長軌跡。

  • I'll now provide financial highlights for the period ending June 30, 2024. With respect to our operating performance, total revenues for the first half of 2024 were $236 million versus $20 million in the first half of the prior year, representing over a tenfold increase. As we previously announced, this was driven by our strong Q2 performance, where total revenues for the quarter were $199 million versus $4 in the prior year.

    我現在將提供截至 2024 年 6 月 30 日的財務摘要。就我們的經營業績而言,2024 年上半年的總收入為 2.36 億美元,而上年上半年為 2,000 萬美元,成長了十倍多。正如我們之前宣布的,這是由我們強勁的第二季度業績推動的,該季度的總收入為 1.99 億美元,而去年同期為 4 美元。

  • In the second quarter alone, we recognized $145 million in milestones and product revenues of $54 million. We're pleased to report that these are the highest milestone and product revenues reported by Alvotech to date.

    光是第二季度,我們就實現了 1.45 億美元的里程碑,產品收入為 5,400 萬美元。我們很高興地報告,這是 Alvotech 迄今為止報告的最高里程碑和產品收入。

  • The significant milestones recognized in Q2 were driven by a number of triggers which were achieved during the period. As a reminder, our commercial agreements provide for development and performance-based milestones, as well as an out-licensing arrangement for our commercial rights, whereby we have a revenue and, or profit sharing arrangement once our products are commercialized.

    第二季度實現的重要里程碑是由在此期間實現的許多觸發因素所推動的。提醒一下,我們的商業協議規定了基於開發和性能的里程碑,以及我們商業權利的向外許可安排,一旦我們的產品商業化,我們就有收入和/或利潤分享安排。

  • In the case of milestones, we collect cash from our partners at signing and during the development phases of our programs, which helps to offset the overall costs of development for our programs.

    就里程碑而言,我們在專案簽約時和開發階段向合作夥伴收取現金,這有助於抵消專案開發的整體成本。

  • We recognize revenue as we advance our programs through the pipeline. Specifically, we recognize revenue upon the commencement of the clinical phase of development, upon achievement of positive top-line results, upon submission of marketing applications, and upon regulatory approval.

    當我們透過管道推進我們的專案時,我們會確認收入。具體來說,我們在臨床開發階段開始、取得積極的頂線結果、提交行銷申請以及監管部門批准後確認收入。

  • Additionally, performance-based milestones are recognized upon first launch by our commercial partners and, in some cases, the achievement of cumulative net sales targets. The overwhelming majority of our expected milestones are recognized at or prior to launch.

    此外,基於績效的里程碑在我們的商業合作夥伴首次推出時以及在某些情況下實現累計淨銷售目標時得到認可。我們絕大多數的預期里程碑都是在發佈時或發布之前得到認可的。

  • During the second quarter, we announced positive top line results for our AVT05 and AVT03 programs. Additionally, we recognized performance based milestones due to the first launches of AVT02 in the US, AVT04 in ex-US markets, and the achievement of net sales targets for ongoing ex-US commercialization of AVT02.

    在第二季度,我們宣布了 AVT05 和 AVT03 項目的積極營收結果。此外,由於 AVT02 在美國首次推出、AVT04 在美國以外市場首次推出,以及 AVT02 持續在美國以外市場商業化的淨銷售目標的實現,我們認可了基於績效的里程碑。

  • The culmination of these events contributed to the milestone revenues recognized during the period. It's important to note that we view milestone revenues as an ongoing part of our business model, and that they represent strategic investment from our commercial partners.

    這些事件的高潮促成了該期間確認的里程碑收入。值得注意的是,我們將里程碑收入視為我們業務模式持續的一部分,並且它們代表了我們商業合作夥伴的策略投資。

  • Additional milestones will be recognized in the second half of this year due to our commercial launch of the biosimilar version of Stelara into European markets. And we also anticipate submitting three new marketing authorizations in major markets later this year.

    由於我們在歐洲市場商業推出 Stelara 生物相似藥版本,今年下半年將實現更多里程碑。我們也預計今年稍後在主要市場提交三項新的行銷授權。

  • In terms of product revenues, as Robert and Anil have already highlighted, our commercial partners have commenced the launch of our biosimilar to Humira in the US. During the second quarter, shipments to our US partners increased, driving an overall increase in product revenues versus the prior quarter of $41 million.

    就產品收入而言,正如羅伯特和阿尼爾已經強調的那樣,我們的商業合作夥伴已開始在美國推出我們的 Humira 生物相似藥。第二季度,我們向美國合作夥伴的出貨量增加,推動產品收入較上一季整體成長 4,100 萬美元。

  • Additionally, during the first half of the year, our partners ex-US have also commenced the launch of our biosimilar to Stelara in Canada, Japan, and our European partner launched into select European markets in July. As these launches have only just begun, you can expect us to continue ramping up production, driving a progressive increase in product revenues throughout the year.

    此外,今年上半年,我們的美國以外合作夥伴也開始在加拿大、日本推出我們的 Stelara 生物相似藥,我們的歐洲合作夥伴則於 7 月在部分歐洲市場推出。由於這些產品的推出才剛開始,您可以預期我們將繼續提高產量,從而推動全年產品收入的逐步成長。

  • Operating profit was $43 million for the first half of 2024, compared to negative $189 million for the same period in 2023. The increase of $233 million, or 123% was primarily attributable to the sharp increase in total revenues coupled with lower cost of product revenues due to reduced production-related charges and lower costs associated with FDA inspection readiness. Additionally, the decrease in operating expenses were driven by continuing efforts from the company to scale and optimize operations.

    2024 年上半年營業利潤為 4,300 萬美元,而 2023 年同期為負 1.89 億美元。增加 2.33 億美元,即 123%,主要歸因於總收入的急劇增加,以及由於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降低。此外,營運費用的下降是由於公司不斷努力擴大和優化營運。

  • For the first half of 2024, we reported adjusted EBITDA of $64 million versus negative $147 million during the same period in the prior year. In Q2 2024, we reported adjusted EBITDA of $102 million versus negative $81 million during the second quarter of 2023. This is largely driven by the gross margin contribution in the period, slightly tempered by higher OpEx costs, particularly higher R&D costs on an adjusted basis. Please see the table provided in the appendix for a reconciliation of our reported to adjusted results.

    2024 年上半年,我們報告調整後 EBITDA 為 6,400 萬美元,而去年同期為負 1.47 億美元。2024 年第二季度,我們報告調整後 EBITDA 為 1.02 億美元,而 2023 年第二季為負 8,100 萬美元。這主要是由該期間的毛利率貢獻推動的,但由於營運支出成本上升,特別是調整後的研發成本上升而略有緩和。請參閱附錄中提供的表格,以了解我們的報告與調整結果的調節。

  • In terms of cash and liquidity, we closed the period ending June 30 with $11 million of cash on hand and $1.056 billion in net borrowings. Giving effect to the refinancing we completed in July, we closed the period with $178 million of cash on hand, including $25 million of restricted cash and $1.35 billion in gross borrowings. With this refinancing behind us, our major product launches underway and continued advancement of our pipeline, the company has sufficient cash on hand to continue preparing for our ongoing and near-term biosimilar launches.

    就現金和流動性而言,截至 6 月 30 日止期間,我們手頭現金為 1,100 萬美元,淨借款為 10.56 億美元。考慮到我們 7 月完成的再融資,我們在本季末手頭現金為 1.78 億美元,其中包括 2,500 萬美元的限制性現金和 13.5 億美元的總借款。隨著這次再融資的完成、我們主要產品的推出以及我們的管道的持續推進,該公司手頭上有足夠的現金來繼續為我們正在進行的和近期的生物仿製藥的推出做準備。

  • We closed the period ending June 30 with 279.4 million shares outstanding, including unvested earn-out shares. Taking into effect the conversion of convertible bonds on July 1, which resulted in the issuance of 22.1 million shares, we have 301.5 million pro forma shares outstanding as of June 30. In the appendix to our management presentation, you will find a summary of outstanding shares.

    截至 6 月 30 日止期間,我們已發行 2.794 億股流通股,其中包括未歸屬的獲利股。自 7 月 1 日可轉換債券轉換生效(發行 2,210 萬股)以來,截至 6 月 30 日,我們已發行備考股票 3.015 億股。在我們的管理層介紹的附錄中,您將找到已發行股票的摘要。

  • Turning to the next slide, I will close today's presentation with a reminder that our performance in 2024 will be driven by a number of concurrent opportunities. Our revenue guidance remains at $400 million to $500 million and is driven by a combination of our newly planned product launches and significant development and performance-based milestones that we expect to achieve throughout the year.

    轉向下一張投影片,我將在結束今天的簡報時提醒大家,我們 2024 年的業績將受到許多並發機會的推動。我們的收入指引保持在 4 億至 5 億美元,是由我們新計劃的產品發布以及我們預計全年實現的重大開發和基於性能的里程碑共同推動的。

  • Overall, we expect milestone revenue contributions to be in the range of $190 million to $200 million in 2024. We're excited to demonstrate the continued advancement of our pipeline, which will propel sustainable long-term growth of the company.

    整體而言,我們預期 2024 年里程碑式的營收貢獻將在 1.9 億至 2 億美元之間。我們很高興能夠展示我們管道的持續進步,這將推動公司的可持續長期成長。

  • As previously guided, adjusted EBITDA for the year is forecasted in the range of $100 million to $150 million. Delivering our first positive EBITDA quarter and half year was a significant achievement for Alvotech and we will continue to be focused on operational execution to maximize the potential of our launches in the second half of 2024.

    按照先前的指引,今年調整後的 EBITDA 預計在 1 億至 1.5 億美元之間。對於 Alvotech 來說,實現第一個季度和半年的正 EBITDA 是一項重大成就,我們將繼續專注於營運執行,以最大限度地發揮我們在 2024 年下半年推出的產品的潛力。

  • We expect product revenues to overtake milestone revenues towards the end of 2024. As we've mentioned in the past, we continue to anticipate this year will be lumpy in terms of our operating results from one quarter to the next.

    我們預計到 2024 年底,產品收入將超過里程碑收入。正如我們過去所提到的,我們仍然預計今年的營運業績將在一個季度到下一個季度出現波動。

  • Heading into the second half of 2024, we anticipate contributions from milestone revenues to decrease in the second half. And that product revenues will outpace milestone revenues starting in the third quarter. And while we expect Q3 to be another positive EBITDA quarter, most of our second half EBITDA will be achieved in the fourth quarter of 2024, which mirrors our supply schedule, as noted by Robert and Anil in earlier comments.

    進入 2024 年下半年,我們預計下半年里程碑收入的貢獻將減少。從第三季開始,該產品收入將超過里程碑收入。雖然我們預計第三季將是另一個正EBITDA 季度,但我們下半年的EBITDA 大部分將在2024 年第四季度實現,這反映了我們的供應計劃,正如Robert 和Anil 在之前的評論中指出的那樣。

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

    這樣,我想將電話轉回給我們的接線生進行問答。

  • Operator

    Operator

  • Thank you. (Operator Instructions)

    謝謝。(操作員說明)

  • Carl Byrnes, Northland Capital Markets.

    卡爾‧伯恩斯,北國資本市場。

  • Carl Byrnes - Analyst

    Carl Byrnes - Analyst

  • Thanks for the question and congratulations on your progress. If we look at the existing partnerships that you have in place, what is the outstanding potential milestone revenue that you could achieve from those agreements? And then I have a follow on as well. Thank you.

    感謝您的提問並祝賀您的進步。如果我們看看您現有的合作夥伴關係,您可以從這些協議中實現的潛在里程碑收入是多少?然後我也有後續。謝謝。

  • Joel Morales - Chief Financial Officer

    Joel Morales - Chief Financial Officer

  • Thanks, Carl. This is Joel. We currently have over $1 billion of milestones yet to be collected as a result of the agreements that we have in place.

    謝謝,卡爾。這是喬爾.由於我們已達成的協議,目前我們還有超過 10 億美元的里程碑尚未完成。

  • Carl Byrnes - Analyst

    Carl Byrnes - Analyst

  • Great, excellent. And then with respect to gross profit margin on product sales, what sort of progression should we look for there? I think, it was around, on adjusted base of 17%. How might that ramp as you lever off of a higher revenue base? Thanks.

    太棒了,太棒了。那麼,就產品銷售的毛利率而言,我們應該尋找什麼樣的進度呢?我認為,調整後的基數為 17%,大約是這樣。當你利用更高的收入基礎時,這種成長會如何成長?謝謝。

  • Joel Morales - Chief Financial Officer

    Joel Morales - Chief Financial Officer

  • Yes, that's right, Carl. So our Q2 product margins were almost 17%, really driven by the initial shipments into the US of our launch of AVT02, resupply of our ex-US partners of AVT02, as well as pre-launch stocking for our European partner. I think what I can say is that, we expect our product margins to continue to increase quarter-over-quarter, driven by the increase in volumes and product mix, particularly in the fourth quarter.

    是的,沒錯,卡爾。因此,我們第二季的產品利潤率幾乎為17%,這實際上是由我們推出的AVT02 首次向美國發貨、對AVT02 的美國前合作夥伴的再供應以及我們的歐洲合作夥伴的上市前庫存推動的。我認為我可以說的是,在銷售和產品組合增加的推動下,我們預計我們的產品利潤率將繼續逐季度增加,特別是在第四季度。

  • Operator

    Operator

  • Kirsty Ross Stewart, Citi.

    花旗銀行的科斯蒂·羅斯·史都華。

  • Kirsty Ross-Stewart - Analyst

    Kirsty Ross-Stewart - Analyst

  • Hi there. Kirsty Ross Stewart from Citi on behalf of -- . Just three, if I may. On SIMLANDI, I noted your comments about visibility on the order book as we go into the second half of this year. So perhaps just a question looking into 2025. Could you elaborate a little bit more on the main puts and takes behind the success of the commercial launch in the US, specifically the importance of expanding access further versus kind of doubling down on your existing commercial agreement with QUALLENT.

    你好呀。花旗代表 Kirsty Ross Stewart——。如果可以的話,只有三個。在 SIMLANDI 上,我注意到你們對今年下半年訂單簿可見性的評論。所以也許只是一個展望 2025 年的問題。您能否詳細說明在美國商業發布成功背後的主要因素,特別是進一步擴大訪問範圍與加倍與 QUALLENT 的現有商業協議的重要性。

  • So, I mean, so now that you're kind of a few months into the launch of any potential challenges that you're keeping an eye on, competition from other brands or messaging around biosimilars versus branded products.

    所以,我的意思是,現在距離您關注的任何潛在挑戰、來自其他品牌的競爭或圍繞生物仿製藥與品牌產品的訊息傳遞已經過去了幾個月。

  • And then just a really quick one on AVT06, your Eylea biosimilar. Can you just remind us what you're saying at the moment about timing for a US launch? Thanks.

    然後快速了解 AVT06(您的 Eylea 生物相似藥)。您能否提醒我們您目前所說的在美國推出的時間?謝謝。

  • Anil Okay - Board Member

    Anil Okay - Board Member

  • Thank you very much for the question. So let me start with the Humira ramp. Just to remind, as you know, we still are the only interchangeable high concentration, size rate free Humira biosimilar in the US market, and we also have our exclusivity up until May 2025. So basically, we have the best product profile in the US market this year and also almost half of next year. So that's a big advantage.

    非常感謝你的提問。讓我從 Humira 坡道開始。只是提醒一下,如您所知,我們仍然是美國市場上唯一可互換的高濃度、無尺寸率的 Humira 生物仿製藥,並且我們的獨家經營權截止到 2025 年 5 月。所以基本上,我們今年和明年幾乎一半的產品在美國市場都是最好的。所以這是一個很大的優勢。

  • Talking about the ramp, we are definitely in a very good position to drive growth and we expect the ramp to continue and expand it next year. As we have said, we have a sizable firm order book and we also have really only started our supply journey as you know. With the feedback from orders next year, starting to also look very good.

    談到成長,我們絕對處於推動成長的非常有利的位置,我們預計明年成長將繼續並擴大。正如我們所說,我們有相當大的訂單,而且如您所知,我們的供應之旅才剛剛開始。從明年訂單的回饋來看,開始看起來也很不錯。

  • The comments from Cigna are of course encouraging. The coverage extension led by Teva, which is really just a start, and is encouraging. Also the recent comments from Mickelson regarding Humira revenues are also a sign in the right direction for biosimilars.

    Cigna 的評論當然令人鼓舞。由 Teva 領導的覆蓋範圍擴展實際上只是一個開始,而且令人鼓舞。此外,米克森最近關於 Humira 收入的評論也是生物相似藥走向正確方向的標誌。

  • Just a reminder, we were the last adalimumab approved in the US, but we find ourselves with major coverage, private label deal, and a substantial order book with effectively a media launch. So we believe strongly that this is driven by product profile, dedicated capacity, a quality commercial partner, and portfolio-driven approach. So we feel very good about where we stand today, and we also expect to be one of the leaders in this market.

    提醒一下,我們是最後一個在美國獲得批准的阿達木單抗,但我們發現自己擁有重大報道、自有品牌交易和大量訂單,並有效地進行了媒體發布。因此,我們堅信,這是由產品概況、專用能力、優質商業合作夥伴和投資組合驅動方法所驅動的。因此,我們對今天的處境感到非常滿意,我們也期望成為這個市場的領導者之一。

  • Looking into your second question regarding Eylea launch timing for the US, the timing is to be determined, but we feel strongly that we will be there on day one. There are other markets including Europe where the timing is more clear and we expect that to be sometime next year. Thank you.

    關於你關於 Eylea 在美國推出時間的第二個問題,時間尚未確定,但我們強烈認為我們將在第一天到達那裡。包括歐洲在內的其他市場的時機更為明確,我們預計在明年的某個時候。謝謝。

  • Operator

    Operator

  • Thank you. (Operator Instructions)

    謝謝。(操作員說明)

  • There are no further questions at this time. I would like to hand back over to the speakers for closing remarks.

    目前沒有其他問題。我想請發言者致閉幕詞。

  • Benedikt Stefansson - Director of Investor Relations & Global Communications

    Benedikt Stefansson - Director of Investor Relations & Global Communications

  • Thank you, Sandra. And on behalf of the Alvotech team, I want to thank everybody who joined us for this Q2, 2024 earnings call today. We look forward to speaking with you all again and wish you a great rest of the day.

    謝謝你,桑德拉。我謹代表 Alvotech 團隊感謝今天參加我們 2024 年第二季財報電話會議的所有人。我們期待再次與大家交談,並祝您有個愉快的一天。