Alvotech SA (ALVO) 2023 Q4 法說會逐字稿

Good morning or afternoon to everyone joining this call today. Yesterday evening, the company issued a press release that can be found in the News section of our investor portal, investors.alvotech.com. The release outlines key highlights related to our full-year 2023 results.

今天參加本次電話會議的大家早安或下午好。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 的新聞部分找到該新聞稿。新聞稿概述了與我們 2023 年全年業績相關的主要亮點。

Additionally, we will, throughout today's call, refer to a slide presentation, which is available on our investor website in the Events section. If you have not already accessed the slides, please go to investors.alvotech.com and select Events.

此外，在今天的電話會議中，我們將參考幻燈片演示文稿，該幻燈片可在我們的投資者網站的「活動」部分中找到。如果您尚未存取這些投影片，請造訪 Investors.alvotech.com 並選擇「活動」。

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 and the Nasdaq Iceland Stock Exchange. These risks and uncertainties could cause actual results to differ materially from forward-looking statements that we make.

我們的演示材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和納斯達克冰島證券交易所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我們所做的前瞻性陳述有重大差異。

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

與我一起參加今天電話會議的是 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，戰略官。

With that, I would like to turn the call over to Robert Wessman, Founder, Chairman and CEO of Alvotech.

現在，我想將電話轉給 Alvotech 的創辦人、董事長兼執行長 Robert Wessman。

Thank you, Benedikt. And thank you all for joining us on today's earnings call and business update for the full year 2023.

謝謝你，貝內特。感謝大家參加今天的財報電話會議和 2023 年全年業務更新。

We are very excited about the position that we find ourselves in today. Alvotech has successfully cleared our inspection status with the US FDA. This puts Alvotech in a position to access the largest pharma market in the world. This result has led to approval of Simlandi in US and also clears the way for our biosimilar to Stelara, which we expect will be approved by FDA next month. Additionally, our pipeline has been steadily progressing, and we are in a position to file at least three applications for new biosimilar candidates this year. And those are just a few of the events that are driving excitement and anticipation here at Alvotech.

我們對今天所處的位置感到非常興奮。Alvotech 已成功取得美國 FDA 的檢驗資格。這使得 Alvotech 能夠進入世界上最大的製藥市場。這一結果導致 Simlandi 在美國獲得批准，也為我們的 Stelara 生物相似藥掃清了道路，我們預計該生物仿製藥將於下個月獲得 FDA 批准。此外，我們的管道一直在穩步進展，今年我們有能力提交至少三份新的生物相似藥候選藥物申請。這些只是 Alvotech 令人興奮和期待的一些活動。

But before we discuss in more details regarding 2023 and take a look into 2024, I would like to take a step back for a moment to recap our strategy and positioning. Alvotech is proud to be focused entirely on biosimilars, which position us amongst a small group of companies dedicated to meet the global need, driven by the high-cost biologic medicines. Further, we are vertically integrated with end-to-end capabilities and have established a comprehensive infrastructure platform from where we can develop or manufacture biosimilars. Having this dedicated infrastructure will further differentiate us from other biosimilar developers.

但在我們更詳細地討論 2023 年並展望 2024 年之前，我想先回顧一下我們的策略和定位。Alvotech 很自豪能夠完全專注於生物相似藥，這使我們躋身於少數致力於滿足由高成本生物藥物驅動的全球需求的公司之中。此外，我們具有端到端能力的垂直整合，並建立了一個全面的基礎設施平台，我們可以在其中開發或製造生物相似藥。擁有這種專用基礎設施將進一步將我們與其他生物相似藥開發商區分開來。

We also have a multi-product portfolio-based strategy. With our recent launch of Jamteki, our biosimilar, to Stelara in Canada, we have two different molecules now on the market. We continue to grow and advance our overall pipeline and portfolio, which has 11 disclosed asset today. And finally, we have a global regulatory and commercial strategy as we see biosimilars as both a global opportunity and necessity.

我們還有基於多產品組合的策略。隨著我們最近向加拿大的 Stelara 推出生物相似藥 Jamteki，我們現在在市場上有兩種不同的分子。我們繼續發展和推動我們的整體管道和投資組合，目前已披露 11 項資產。最後，我們制定了全球監管和商業策略，因為我們將生物相似藥視為全球機會和必要性。

A global strategy allows us to maximize the return of our development investment and provides diversification and longer-term durability to our portfolio assets. The hard work and investment that has been put into Alvotech over the past decade has now positioned us at an inflection point, where we expect growth in revenues based on multiple launches in major markets, while concurrently advancing a pipeline of attractive biosimilar candidates.

全球策略使我們能夠最大限度地提高開發投資的回報，並為我們的投資組合資產提供多元化和長期耐用性。過去十年對 Alvotech 的辛勤工作和投資現已使我們處於一個拐點，我們預計收入將基於主要市場的多次上市而增長，同時推進一系列有吸引力的生物仿製藥候選產品。

2023 was a year but can be defined as laying the foundation for the future growth. The first element of that foundation is reflected in our global regulatory approvals, which enables a steady schedule of commercial launches for 2024, 2025, and beyond. Simlandi was approved as first interchangeable high-concentration biosimilar to Humira in the US market. And while the approval occurred in 2024, the hard work and dedication from the team to secure inspection readiness in 2023 have to pave the way for this approval.

2023年是一年，但可以定義為未來成長奠定基礎的一年。該基礎的第一個要素體現在我們的全球監管批准中，這使得我們能夠在 2024 年、2025 年及以後製定穩定的商業發佈時間表。Simlandi 是美國市場上第一個可與 Humira 互換的高濃度生物相似藥。雖然批准發生在 2024 年，但團隊為確保 2023 年檢查準備就緒而付出的辛勤工作和奉獻精神必須為此批准鋪平道路。

Approval of our Stelara biosimilar in Canada, Japan, and Europe further demonstrates and validates the platform's ability to gain global regulatory approvals on multiple products in major markets. And thus, importantly, these approvals will enable near-term diversification of revenue.

我們的 Stelara 生物相似藥在加拿大、日本和歐洲獲得批准，進一步證明並驗證了該平台有能力在主要市場的多種產品上獲得全球監管機構的批准。因此，重要的是，這些批准將實現近期收入多元化。

For the US, our AVT04 application was reviewed and deemed approvable by FDA. The outstanding issue for approval was a successful site inspection, which was the same as with Simlandi. The recent approval of Simlandi provides us significant confidence that AVT04 will gain final approval in US in April of this year.

在美國，我們的 AVT04 申請已獲得 FDA 審查並被視為批准。待批准的未決問題是成功的現場檢查，這與西姆蘭迪的情況相同。Simlandi 最近的批准讓我們對 AVT04 將於今年 4 月在美國獲得最終批准充滿信心。

Of course, what has enabled these approvals is the dedication of Alvotech team to compliance and inspection readiness. And that is not only for the US FDA, but for all regulatory bodies around the world, where we have or intend to launch our products. I would like to thank our entire team at Alvotech for the efforts made to ensure our positive inspection outcome.

當然，獲得這些批准的原因是 Alvotech 團隊致力於合規和檢查準備。這不僅適用於美國 FDA，也適用於我們已經或打算推出我們產品的世界各地所有監管機構。我要感謝 Alvotech 的整個團隊為確保我們的積極檢查結果所做的努力。

In 2023, we also continue to expand and enhance our commercial network through existing and new strategic partnership. This included an expanded partnership with Teva in the US, as well as with Fuji Pharma in Japan. We also added to our network at Advanz Pharma, with a strategic partnership covering five proposed biosimilars in Europe. Our strategic partnership with well-established and well-recognized companies are fundamental to our ability to ensure that our products find the right home all over the world.

2023年，我們也將透過現有和新的策略合作夥伴關係繼續擴大和增強我們的商業網絡。其中包括擴大與美國梯瓦製藥 (Teva) 以及日本富士製藥 (Fuji Pharma) 的合作關係。我們也擴大了 Advanz Pharma 的網絡，與歐洲五種擬議的生物相似藥建立了戰略合作夥伴關係。我們與知名企業的策略夥伴關係是我們確保我們的產品在世界各地找到合適客戶的基礎。

Finally, 2023 was another year for significant advancement for our pipeline. Alvotech started as a development company, and we aim to maintain that scientific resolve as we mature into global commercial phase as an organization. We have received positive clinical results for AVT06, our proposed biosimilar to Eylea, thus paving the way to a submission later this year.

最後，2023 年是我們的產品線取得重大進展的另一年。Alvotech 最初是一家開發公司，我們的目標是在我們作為一個組織成熟進入全球商業階段時保持這種科學決心。我們提議的 Eylea 生物相似藥 AVT06 已收到積極的臨床結果，為今年稍後的提交鋪平了道路。

Additionally, we have three other programs, in addition to AVT06, that have demonstrated positive PK results and are currently in ongoing patient trials. Please note that as a general rule, passing PK results are more informative to potential approval than results from patient trials, and we are highly confident in our ability to bring these products to the submission phase.

此外，除了 AVT06 之外，我們還有其他三個項目，這些項目已顯示出積極的 PK 結果，目前正在進行患者試驗。請注意，作為一般規則，通過 PK 結果比患者試驗結果更能提供潛在批准的信息，我們對將這些產品帶入提交階段的能力充滿信心。

The proposed biosimilar currently in ongoing patient studies are AVT05, a proposed biosimilar to Simponi and Simponi Aria; AVT03, a biosimilar candidate to Prolia and Xgeva; and also AVT23, a biosimilar candidate to Xolair, a product advancing in partnership with Kashiv; and finally, we advanced our AVT16 program into one of the leading positions in the fast-growing Entyvio market. Looking back at 2023, I can say with great confidence that it has positioned us well to drive growth on both the top line and bottom line in 2024 and beyond, and we are very proud of our achievements in Alvotech.

目前正在進行的患者研究中擬議的生物相似藥是 AVT05，是 Simponi 和 Simponi Aria 的擬議生物相似藥； AVT03，Prolia 和 Xgeva 的候選生物相似藥；還有 AVT23，Xolair 的生物相似藥候選藥物，Xolair 是與 Kashiv 合作開發的產品；最後，我們將 AVT16 計劃推向快速成長的 Entyvio 市場的領先地位之一。回顧 2023 年，我可以充滿信心地說，它使我們能夠很好地推動 2024 年及以後的收入和利潤成長，我們對 Alvotech 的成就感到非常自豪。

Now, looking ahead, we see 2024 as a transformational year for the company. It starts with launches of major products into large markets. Our launch of Simlandi in the US will occur in early second quarter. And as the only high-concentration interchangeable product on the market, we have high confidence in this launch.

現在，展望未來，我們認為 2024 年是公司轉型的一年。首先是向大市場推出主要產品。我們將於第二季初在美國推出 Simlandi。而作為市場上唯一的高濃度可互換產品，我們對這次的推出充滿信心。

Earlier this year, together with our partner, JAMP Pharma, we launched our biosimilar to Stelara in Canada with a brand name of Jamteki. This represents the first launch of Stelara biosimilar in the Canadian market. We aim to launch our Stelara biosimilar in Japan in the second quarter of this year and then in Europe beginning of third quarter this year. These multiple launches will bring material revenues into Alvotech and create a diversification of the top line from both markets and products.

今年早些時候，我們與合作夥伴 JAMP Pharma 一起在加拿大推出了 Stelara 生物相似藥，品牌名稱為 Jamteki。這是 Stelara 生物相似藥首次在加拿大市場上市。我們的目標是今年第二季在日本推出 Stelara 生物相似藥，然後在今年第三季初在歐洲推出。這些多次推出將為 Alvotech 帶來實質收入，並實現市場和產品收入的多元化。

In addition to the commercial launches just mentioned, we will also be preparing for our launch of AVT04, our Stelara biosimilar candidate, in the US. While the commercial launch is in early 2025, we will be supplying later in 2024 allowance quantities, and we may generate additional revenues depending on [circular] timing in 2024.

除了剛才提到的商業上市外，我們還將準備在美國推出 Stelara 生物相似藥候選產品 AVT04。雖然商業發布將於 2025 年初進行，但我們將在 2024 年稍後提供配額數量，並且我們可能會根據 2024 年的[通告]時間產生額外收入。

But as important as commercial launches are, it is equally important that we continue to drive advancement in our pipeline. 2024 is set to be a busy year in our portfolio as we expect at least three additional submissions in major markets this year. Additionally, in our pipeline, we intend to advance our AVT16 program to the clinical trial phase.

但與商業發布一樣重要的是，我們繼續推動我們的產品線的進步也同樣重要。 2024 年對我們的投資組合來說將是忙碌的一年，因為我們預計今年在主要市場將至少有另外三份提交。此外，在我們的管道中，我們打算將 AVT16 計畫推進到臨床試驗階段。

Finally, we continue pursuing more business development transactions and remain in active negotiation for available assets in our portfolio. In 2024, we expect to see multiple launches and significant growth in milestone revenues coming from highly visible and derisked programs.

最後，我們繼續尋求更多的業務開發交易，並繼續就我們投資組合中的可用資產進行積極談判。到 2024 年，我們預計將看到高度可見且低風險的項目將推出多項項目，並帶來里程碑式收入的顯著成長。

We are now in a position to guide the market for 2024 and 2025 on top line and where we expect to land on EBITDA in 2024. Later in this presentation, our CFO, Joel Morales, will cover guidance in greater detail.

我們現在能夠引導 2024 年和 2025 年的市場收入，並預計 2024 年 EBITDA 達到目標水準。在本次演講的後面部分，我們的財務長喬爾·莫拉萊斯 (Joel Morales) 將更詳細地介紹指導意見。

I would, with those words, like to turn now the call over to Anil Okay, our Chief Commercial Officer, to dive deeper into our upcoming launches and portfolio updates. Anil, over to you.

我現在想把電話轉給我們的首席商務官阿尼爾·奧凱，讓他更深入地了解我們即將推出的產品和產品組合更新。阿尼爾，交給你了。

Thank you, Robert, and thank you to everyone on the call today.

謝謝羅伯特，也謝謝今天參加電話會議的所有人。

I would like to start with our recent approval of Simlandi. Simlandi is the first interchangeable high-concentration biosimilar to Humira in the US market. We view this approval as a victory for patients in the US, as we believe the product profile that combines interchangeability with the high-concentration strengths will help expand conversion in the US market, where we have seen minimal usage of biosimilar Humira to date.

我想從我們最近對 Simlandi 的批准開始。Simlandi 是美國市場上第一個可與 Humira 互換的高濃度生物相似藥。我們認為此次批准對美國患者來說是一次勝利，因為我們相信將互換性與高濃度優勢相結合的產品概況將有助於擴大美國市場的轉化，迄今為止，我們在美國市場上看到生物相似藥Humira 的使用量很少。

Moreover, we know that we have exclusivity for our interchangeable designation in our approved presentations. While we always expect the exclusivity, the confirmed nature of that exclusivity is a very helpful point in the outreach to the market, where we have coordinated closely with our partner channel. And as a reminder, the high concentration form of Humira is the dominant form used by patients today.

此外，我們知道我們在批准的簡報中擁有可互換名稱的排他性。雖然我們始終期望獲得排他性，但這種排他性的確認性質對於拓展市場非常有幫助，我們與合作夥伴管道密切協調。需要提醒的是，高濃度修美樂是當今患者使用的主要形式。

Moving to slide 10, in today's presentation, I would like to dive a bit deeper in the commercial approach for Simlandi in the US, which we divide into four pillars. The first was just discussed regarding our unique product profile and the exclusivity that helps protect against other seeking interchangeable designation.

轉到投影片 10，在今天的簡報中，我想更深入地探討 Simlandi 在美國的商業方法，我們將其分為四個支柱。第一個問題剛剛討論了我們獨特的產品概況和排他性，有助於防止其他人尋求可互換的名稱。

On the pricing front, Teva's plan will be a two-tier pricing strategy that will enable us to serve patients more broadly across both commercial and government-insured patients. Currently, our partner supported by us are in active discussions with the PBMs to secure formulary placements. As part of that, the finalization of these negotiations will provide us better clarity on final net pricing.

在定價方面，梯瓦的計劃將是一個兩級定價策略，這將使我們能夠更廣泛地為商業和政府保險患者提供服務。目前，我們支持的合作夥伴正在與 PBM 積極討論，以確保處方安排。作為其中的一部分，這些談判的最終確定將使我們對最終淨定價更加清晰。

The next key part of our commercial strategy is to ensure consistent and uninterrupted supply. Alvotech has a manufacturing site that's 100% dedicated to our products. We have, in the past, hosted our major potential customers at our site so they could get a firsthand look at our production capabilities. Our supply plan remains on track, and the launch is expected imminently after first ships.

我們商業策略的下一個關鍵部分是確保持續且不間斷的供應。Alvotech 擁有一個 100% 專用於我們產品的生產基地。過去，我們曾在我們的現場接待過主要的潛在客戶，以便他們能夠親眼目睹我們的生產能力。我們的供應計劃仍在按計劃進行，預計在第一艘船交付後立即推出。

Finally, I would like to comment on our auto-injector platform. Some of our products in the pipeline require an auto-injector. Humira, as an example, is a treatment for many chronic indications. It is also taken often 26 times per year. Patients and physicians develop a relationship with their commonly used device. And as a developer, we wanted to ensure that we brought to market a device that bears the patient's experience in mind.

最後，我想評論一下我們的自動注射器平台。我們正在開發的一些產品需要自動注射器。例如，Humira 是一種治療許多慢性適應症的藥物。每年也常進行 26 次。患者和醫生與他們常用的設備建立了關係。作為開發商，我們希望確保我們向市場推出的設備能夠考慮到患者的體驗。

As a result, we formed collaboration with Ypsomed, a leading company in the device sector, to create a proprietary auto-injector platform. That device was supported by two separate design-focused clinical trials, including a trial conducted in adult patients with moderate to severe active rheumatoid arthritis, which assess the real-life patient handling experience of the auto-injector.

因此，我們與設備領域的領先公司 Ypsomed 合作，創建了一個專有的自動注射器平台。該設備得到了兩項獨立的以設計為重點的臨床試驗的支持，其中包括一項在患有中度至重度活動性類風濕關節炎的成年患者中進行的試驗，該試驗評估了自動注射器在現實生活中的患者處理體驗。

In closing, we are in active discussions with the market in the US, and we believe that our overall strategy for Simlandi has put us in a good position to gain broad coverage in the US and help drive expanded use of biosimilars in the Humira market.

最後，我們正在與美國市場進行積極討論，我們相信 Simlandi 的整體策略使我們處於有利地位，能夠在美國獲得廣泛的覆蓋，並有助於推動生物相似藥在 Humira 市場的擴大使用。

Moving to our second product in our portfolio, our biosimilar to Stelara, we are elated at the regulatory progress to date and are set up to have multiple launches across major geographies in 2024 and 2025. And unlike our ex-US launches of AVT02, we aim to be first to launch in many of these markets for Stelara biosimilar.

轉向我們產品組合中的第二個產品，即 Stelara 生物仿製藥，我們對迄今為止的監管進展感到滿意，併計劃於 2024 年和 2025 年在主要地區進行多次上市。與我們在美國以外地區推出的 AVT02 不同，我們的目標是首先在許多這些市場推出 Stelara 生物相似藥。

Let me start in Canada, where our partner, JAMP Pharma, has recently launched Jamteki. We were the first to launch in Canada, and as of today, there is only one other approval, and that's held by [Amgen]. Next quarter, we expect to launch in Japan through our partner, Fuji Pharma. In Japan, we are currently the only company approved with a Stelara biosimilar. In Europe, we are expecting launches beginning in Q3 of this year. And in that market, we see only Samsung with the current approval for a Stelara biosimilar.

讓我從加拿大開始，我們的合作夥伴 JAMP Pharma 最近在加拿大推出了 Jamteki。我們是第一個在加拿大推出的公司，截至今天，只有一個其他批准，即由[安進]。下個季度，我們預計透過我們的合作夥伴富士製藥在日本推出。在日本，我們是目前唯一獲得 Stelara 生物相似藥批准的公司。在歐洲，我們預計今年第三季開始推出。在該市場中，我們看到目前只有三星獲得了 Stelara 生物相似藥的批准。

These markets are both substantial in value and growing in volume. Stelara is a higher-priced product, and our view is that the availability of biosimilar Stelara can help increase access and, therefore, volume in a number of markets around the world.

這些市場價值巨大且數量不斷增長。Stelara 是一種價格較高的產品，我們認為生物相似藥 Stelara 的可用性有助於增加全球許多市場的使用機會，從而增加銷售量。

As a precedent, when Humira biosimilars were made available in Europe in 2018, the usage of adalimumab as a molecule increased by double-digit percentages several years in a row. We see a similar opportunity in Stelara. In the US, we expect approval of our Stelara biosimilar candidate in April of this year, which allows for plenty of time to prepare for February 2025 launch.

作為先例，當 Humira 生物相似藥於 2018 年在歐洲上市時，阿達木單抗作為分子的使用量連續幾年以兩位數百分比增長。我們在 Stelara 看到了類似的機會。在美國，我們預計 Stelara 候選生物相似藥將於今年 4 月獲得批准，這樣就有充足的時間為 2025 年 2 月的上市做準備。

Shifting focus to our broader pipeline, as previously mentioned, it's essential to keep advancing and expanding our portfolio to secure long-term growth. Furthermore, our organization's ongoing success in obtaining global approvals underscores a powerful message to every market we enter or intend to enter. Alvotech not only is, but also aims to be, a lasting influence in the biosimilars industry.

如前所述，將重點轉移到更廣泛的產品線上，繼續推進和擴大我們的產品組合以確保長期成長至關重要。此外，我們組織在獲得全球批准方面不斷取得的成功，向我們進入或打算進入的每個市場傳達了強有力的信息。Alvotech 不僅是而且致力於對生物相似藥產業產生持久的影響。

Earlier in today's presentation, we provided detailed updates on a number of our near-term pipeline assets. Looking forward, we do expect to continue to submit AVT04 in jurisdictions around the world now that we have a [new CPP] and, soon, an approval in the US, which can be requirements in certain markets in order to file.

在今天的演講中，我們提供了一些近期管道資產的詳細更新。展望未來，我們確實希望繼續在世界各地的司法管轄區提交 AVT04，因為我們已經有了 [新的 CPP]，並且很快就會在美國獲得批准，這可能是某些市場的提交要求。

With respect to partnership opportunities, the focus of our business development activities around partnership discussions are tied to AVT03 and AVT33, where both assets are not partnered in both the US and EU markets. Finding the right partner for these products is a key initiative for 2024. Alvotech, along with our partners around the world, are extremely excited at the opportunity to bring these products to market.

關於合作機會，我們圍繞合作夥伴討論的業務開發活動的重點與 AVT03 和 AVT33 相關，這兩種資產在美國和歐盟市場都沒有合作。為這些產品尋找合適的合作夥伴是 2024 年的關鍵舉措。Alvotech 與我們世界各地的合作夥伴一起對有機會將這些產品推向市場感到非常興奮。

And with that, I would like to turn the call over to Joel Morales, our Chief Financial Officer, to provide an update on 2023 financial performance, as well as an outlook update for the business. Joel?

因此，我想將電話轉給我們的財務長喬爾·莫拉萊斯 (Joel Morales)，以提供 2023 年財務業績的最新資訊以及業務前景的最新資訊。喬爾？

Thanks, Anil. I'll now provide some brief financial highlights for the year ended December 31, 2023.

謝謝，阿尼爾。我現在將提供截至 2023 年 12 月 31 日止年度的一些簡要財務亮點。

In terms of liquidity, we recently announced in February that we completed a private placement with Icelandic and other European investors worth $166 million in gross proceeds. Giving effect to this financing, our pro forma cash balance as of December 31 would have been $172 million, excluding $25.2 million of restricted cash. In terms of our operating performance, total revenues for 2023 were $93.3 million versus $85 million in the prior year, an increase of around 10%.

在流動性方面，我們最近在 2 月宣布與冰島和其他歐洲投資者完成了私募，總收益達 1.66 億美元。這筆融資生效後，截至 12 月 31 日，我們的預期現金餘額將為 1.72 億美元，其中不包括 2,520 萬美元的限制性現金。就我們的經營業績而言，2023 年的總收入為 9,330 萬美元，而上一年為 8,500 萬美元，成長了約 10%。

The company recorded $48.7 million in product revenues for 2023, almost doubling revenues from the same period in the prior year. This sharp increase is driven by the timing of launches that started in the second quarter of 2022. Since then, our partners have continued to expand on share in existing markets throughout Europe and Canada, and we have also launched into Australia in late Q4 of 2023.

該公司 2023 年的產品收入為 4,870 萬美元，幾乎是去年同期的兩倍。這一急劇增長是由 2022 年第二季度開始的發佈時間推動的。從那時起，我們的合作夥伴繼續擴大在整個歐洲和加拿大現有市場的份額，我們還在 2023 年第四季末進入了澳洲。

In particular, we recognized $18.9 million of revenue in the fourth quarter, which proved to be our strongest quarter of 2023, driving full-year revenues consistent with the expectations we communicated during our last earnings call. The company also recorded $42.7 million in milestone revenues in 2023, largely driven by the recognition of $31.6 million of milestone revenues in the fourth quarter as a result of the positive top-line results we achieved on the clinical efficacy and safety study for our AVT06 program, a biosimilar candidate to Eylea.

特別是，我們在第四季度確認了 1890 萬美元的收入，這被證明是我們 2023 年最強勁的季度，推動全年收入與我們在上次財報電話會議上傳達的預期一致。該公司還在2023 年實現了4,270 萬美元的里程碑收入，這主要是由於我們在AVT06 項目的臨床療效和安全性研究中取得了積極的頂線結果，從而在第四季度確認了3,160 萬美元的里程碑收入。 ，Eylea 的生物仿製藥候選藥物。

Another point worthwhile noting is that the cost of product revenue for the year ended December 31, 2023 is disproportionate relative to product revenue due to timing of new launches, scale-up manufacturing activities, production-related charges, and costs associated with FDA inspection readiness. We do expect this to normalize as we've obtained FDA approval and are able to realize increased scale of manufacturing while expanding on our launches. We anticipate that this increase in volumes will have a favorable impact on cost of product revenues, particularly as we increase absorption of our fixed costs.

另一點值得注意的是，由於新產品上市時間、擴大生產活動、生產相關費用以及與 FDA 檢查準備相關的成本，截至 2023 年 12 月 31 日止年度的產品收入成本與產品收入不成比例。 。我們確實希望這種情況能夠正常化，因為我們已經獲得了 FDA 的批准，並且能夠在擴大我們的產品發布的同時擴大生產規模。我們預計產量的增加將對產品收入成本產生有利影響，特別是當我們增加固定成本的吸收時。

We closed the period with 266 million shares outstanding, including unvested earnout shares.

截至本期末，我們已發行 2.66 億股流通股，其中包括未歸屬的獲利股。

Turning to the next slide, you will find our outlook for 2024 and 2025. We are forecasting revenues between $300 million and $400 million in 2024. This 3 to 4 times growth year on year is driven by a combination of our newly planned product launches of AVT02 and AVT04 and significant development and performance-based milestones we expect to achieve throughout the year.

翻到下一張投影片，您將看到我們對 2024 年和 2025 年的展望。我們預計 2024 年的營收將在 3 億至 4 億美元之間。同比增長 3 至 4 倍是由我們新計劃的 AVT02 和 AVT04 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。

With approvals now secured across multiple products and markets, we have begun to take all the necessary steps to enable our planned launches in 2024. Upon approval of Simlandi, our high-concentration and interchangeable version of HUMIRA, we filed variations with the FDA that will enable us to manufacture at an optimized scale. We have, in fact, already begun to manufacture at that scale for our rest-of-world markets as of the end of last year and expect to be able to manufacture at the same scale for the US by mid-year 2024. We expect to begin supplying the US market with pre-launch inventory in the very near term.

隨著多個產品和市場現已獲得批准，我們已開始採取一切必要措施來實現我們計劃於 2024 年推出的產品。在我們的高濃度和可互換版本 HUMIRA Simlandi 獲得批准後，我們向 FDA 提交了變更文件，這將使我們能夠以優化的規模進行生產。事實上，截至去年底，我們已經開始為世界其他市場進行同樣規模的生產，並預計到 2024 年年中能夠為美國進行同樣規模的生產。我們預計在不久的將來開始向美國市場供應上市前庫存。

Concurrently, our commercial partnership is in advanced stages of contracting with key payers in the US. And based on our product profile that includes the combination of high concentration and interchangeability, we are highly optimistic that we will gain broad market coverage. This year, we also expect to launch our biosimilar to Humira and to several additional global markets, including Latin America and the Middle East.

同時，我們的商業合作夥伴關係正處於與美國主要付款人簽訂合約的後期階段。基於我們的產品概況，包括高度集中和可互換性的組合，我們對獲得廣泛的市場覆蓋率非常樂觀。今年，我們也預計向 Humira 以及其他幾個全球市場推出我們的生物相似藥，包括拉丁美洲和中東。

With respect to AVT04, our biosimilar to Stelara, we have already launched in Canada and expect to expand our launches into Japan and Europe in the second and third quarters of this year, respectively. All requisite approvals have been secured in these markets, and we expect to receive FDA approval in the US by next month's BsUFA date. Our launch for the US is planned for February of 2025. However, our forecast assumes we commence recognizing revenues late in the fourth quarter of this year as we ship initial pre-launch inventory into the US. Detailed planning for our US launch is underway.

至於 AVT04（我們的 Stelara 生物相似藥），我們已經在加拿大上市，並預計在今年第二季和第三季分別將上市擴大到日本和歐洲。這些市場已獲得所有必要的批准，我們預計將在下個月的 BsUFA 日期之前獲得美國 FDA 的批准。我們計劃於 2025 年 2 月在美國推出。然而，我們的預測假設我們將在今年第四季末開始確認收入，因為我們將最初的上市前庫存運送到美國。我們正在美國推出的詳細計劃正在進行中。

These launches are not only driving growth in product revenues, but also providing greater diversification in terms of commercial product offering and geographic concentration. They are thus important cornerstones of our strategy to drive growth and profitability over the mid to long term.

這些產品的推出不僅推動了產品收入的成長，而且在商業產品供應和地理集中度方面提供了更大的多樣化。因此，它們是我們推動中長期成長和獲利策略的重要基石。

In terms of milestone revenue, as mentioned earlier, we are anticipating the submission of at least three additional filings in major markets throughout the year for our pipeline. Additionally, we plan to commence clinical trials for our proposed biosimilar to Entyvio, AVT16.

就里程碑收入而言，如前所述，我們預計全年將在主要市場為我們的管道提交至少三份額外的申請。此外，我們計劃開始我們提議的 Entyvio AVT16 生物相似藥的臨床試驗。

Commencing and successfully completing clinical phases of development and regulatory submissions are key events that drive milestone revenue recognition for the company. We're also expecting to recognize milestone revenues for the achievement of certain performance-based targets, such as the first launch of our biosimilars to Humira and Stelara into new markets globally, as well as the achievement of cumulative net sales targets for these launched products.

開始並成功完成開發和監管提交的臨床階段是推動公司實現里程碑式收入確認的關鍵事件。我們也期望在實現某些基於績效的目標時確認里程碑式的收入，例如我們的 Humira 和 Stelara 生物相似藥首次在全球新市場推出，以及這些已推出產品累計淨銷售目標的實現。

The last point I'd like to make regarding milestone revenues is with respect to licensing. As noted earlier in the presentation by Anil, we have an active BD pipeline that has more recently been focused on partnering with our oncology and oncology-related assets. Accordingly, the company is actively pursuing licensing deals for early phase programs with a strategic partner or partners, providing potential upfront cash and milestones over time. We expect milestone revenue contributions to be significant this year and could range up to 40% to 50% of total revenues in 2024.

關於里程碑收入，我想提出的最後一點是關於許可證。正如 Anil 先前在演講中所指出的，我們有一個活躍的 BD 管道，最近專注於與我們的腫瘤學和腫瘤學相關資產合作。因此，該公司正在積極與一個或多個策略合作夥伴尋求早期專案的授權交易，隨著時間的推移提供潛在的預付現金和里程碑。我們預計今年里程碑式的營收貢獻將非常巨大，到 2024 年可能達到總營收的 40% 至 50%。

The advancement of our pipeline not only provides a basis for longer-term growth but generates near-term milestone revenue, which is another core part of our business model. Based on the commercial assumptions I just described, adjusted EBITDA for the year is forecasted in the range of $50 million to $150 million. This includes continued R&D investments behind our pipeline as we advance three of our programs through final stages of clinical and the commencement of our AVT16 program into the clinical phase.

我們管道的進步不僅為長期成長提供了基礎，而且產生了近期里程碑式的收入，這是我們業務模式的另一個核心部分。根據我剛才描述的商業假設，今年調整後的 EBITDA 預計在 5,000 萬至 1.5 億美元之間。這包括我們的管道背後的持續研發投資，因為我們將三個項目推進到臨床的最後階段，以及我們的 AVT16 項目開始進入臨床階段。

I'd like to make a few points with respect to phasing in 2024. Firstly, you can expect this year to be lumpy in terms of our operating results. We expect Q1 total revenues to be lower than Q4 2023. This is driven by a slowdown in production to prepare for the FDA inspection in Q1 and prioritization of development batches to enable our planned submissions in 2024. Also, the timing of milestone triggers have an impact. Accordingly, we expect Q1 to be the lowest quarter of the year in terms of revenue and negative adjusted EBITDA.

我想就 2024 年的分階段問題提出幾點看法。首先，你可以預期今年我們的經營業績將會起伏不定。我們預計第一季總收入將低於 2023 年第四季。這是由於為第一季 FDA 檢查做準備而生產放緩，以及開發批次的優先順序以使我們計劃在 2024 年提交。此外，里程碑觸發的時間也會產生影響。因此，我們預計第一季的營收和調整後的 EBITDA 為負值，將成為今年最低的季度。

In Q2, however, we are expecting to see some initial uptake in product revenues due to our planned launches, and we anticipate achieving a number of milestone recognition triggers in the quarter, which will drive a significant increase in total revenues, and we expect to achieve positive adjusted EBITDA. Finally, we expect product revenues to overtake milestone revenues towards the end of 2024, driving overall revenues and adjusted EBITDA.

然而，在第二季度，由於我們計劃的推出，我們預計產品收入將出現一些初步增長，並且我們預計在本季度實現許多里程碑式的認可觸發器，這將推動總收入的顯著增長，我們預計實現正調整EBITDA。最後，我們預計到 2024 年底，產品收入將超過里程碑收入，從而推動整體收入和調整後 EBITDA。

With respect to our liquidity, we are pleased with the proceeds raised during our last financing round in February. Based on our current operating plans, we believe this provides the company with sufficient cash flows to continue investing behind our planned launches and pipeline throughout the year. We will, of course, continue to monitor the dynamic timing assumptions behind our plan and ensure we are prepared to address any incremental liquidity needs should they arise.

就我們的流動性而言，我們對 2 月上一輪融資籌集的資金感到滿意。根據我們目前的營運計劃，我們相信這將為公司提供足夠的現金流，以繼續投資於我們全年計劃的推出和管道。當然，我們將繼續監控計畫背後的動態時間假設，並確保我們準備好應對任何出現的增量流動性需求。

We expect our capital structure to simplify throughout 2024. Given the recent increase in our share price, the sponsor earnout shares have vested, and one-half of the predecessor earnout shares have also vested during the first quarter of 2024. We have also seen increased exercise of public warrants, which were issued during the de-SPAC transaction that we closed back in 2022.

我們預計 2024 年我們的資本結構將會簡化。鑑於近期我們股價的上漲，發起人的獲利股份已歸屬，前任獲利股份的一半也在 2024 年第一季歸屬。我們也看到公共認股權證的行使有所增加，這些認股權證是在我們於 2022 年關閉的 de-SPAC 交易期間發行的。

Additionally, approximately $300 million of our outstanding borrowings are in the form of convertible instruments, which have a conversion feature that comes available in June of 2024. These activities are expected to reduce the derivative financial liabilities and outstanding borrowings on our balance sheet in the second half of the year. Ultimately, this will also reduce the large swings in finance costs that currently drive volatility in our non-operating results, as well as reducing overall interest expense on the P&L.

此外，我們的未償借款中約有 3 億美元是可轉換工具的形式，其轉換功能將於 2024 年 6 月推出。這些活動預計將減少下半年我們資產負債表上的衍生性金融負債和未償還借款。最終，這也將減少目前導致我們非經營績效波動的財務成本大幅波動，並減少損益表的整體利息支出。

Finally, as we look forward to 2025, we expect to be able to double our total revenues year over year as we intend to continue expanding upon our launches within existing and new markets. With the additional launches and scaling mentioned earlier, product revenue will be the primary driver of growth year on year, with contributions from milestone revenues being proportionately smaller as a share of total revenue.

最後，展望 2025 年，我們計劃繼續在現有和新市場中拓展業務，因此預計總收入將比去年同期翻倍。隨著前面提到的額外發布和擴展，產品收入將成為同比增長的主要驅動力，而里程碑收入的貢獻佔總收入的比例相對較小。

Given that we have just secured approvals for our lead assets in the US and around the world and contracting is ongoing, we believe that this is the best direction that we can provide at the current time. We anticipate an exciting year ahead as we continue to transition into a global full-scale commercial operation, launching multiple products into markets worldwide while, at the same time, advancing our pipeline. We look forward to updating you as the year progresses as more information becomes available.

鑑於我們剛剛獲得美國和世界各地主要資產的批准，並且合約正在進行中，我們相信這是我們目前可以提供的最佳方向。我們預計未來的一年將是令人興奮的一年，因為我們將繼續向全球全面商業營運轉型，向全球市場推出多種產品，同時推動我們的產品線。我們期待隨著時間的推移，隨著更多資訊的出現，向您通報最新情況。

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。

(Operator Instructions) Balaji Prasad, Barclays.

（操作員指示）Balaji Prasad，巴克萊銀行。

Hi. Good morning, everyone -- good afternoon, everyone, and congratulations on the results and what seems to be a compelling outlook for 2024 and 2025. Also, appreciate the color on this because I know you have multiple moving parts to the business between milestones and revenues.

你好。大家早安，大家下午好，祝賀我們取得的成果以及 2024 年和 2025 年令人信服的前景。另外，欣賞它的顏色，因為我知道在里程碑和收入之間業務有多個移動部分。

A couple of questions on this. Firstly, with regard to the revenue cadence that you have provided in the milestones, which are -- could you summarize the key milestone-based events that you're looking for to during the course of the year, especially in 2Q?

對此有幾個問題。首先，關於您在里程碑中提供的收入節奏，您能否總結一下您在這一年中（尤其是第二季度）尋找的基於里程碑的關鍵事件？

And second, I think with the -- where I'm struggling to model is clearly on the gross margins. Can you help us understand how should we think about gross margins? And typically, as inventory builds up before the launch, it looks like you're booking the -- or you have booked the COGS before the revenues get booked. Is that right? Thanks.

其次，我認為我正在努力建模的地方顯然是毛利率。您能幫助我們了解我們應該如何考慮毛利率嗎？通常情況下，隨著庫存在發布之前累積起來，看起來您正在預訂，或者您在預訂收入之前已經預訂了銷貨成本。是對的嗎？謝謝。

I'll take that. Hi, Balaji, and thank you for your question. I'll do my best to address all of those questions.

我會接受的。你好，巴拉吉，謝謝你的問題。我將盡力解決所有這些問題。

I think, firstly, in terms of the revenue cadence, you're right. So the milestones that we're expecting to recognize this year and particularly -- in particular, were driven by the submissions, as well as BLA filings -- I should say, BLA filings, as well as the completion of clinical. We're expecting completion of clinical in the second quarter. We're also expecting key launches. We received milestones upon key launches, and we have several plan in -- obviously, we have one in the US and throughout the world. But in the second quarter, in particular, I think you have some key clinical completions that we're expecting to report out on, as well as the key launch in the US.

我認為，首先，就收入節奏而言，你是對的。因此，我們預計今年將實現的里程碑，尤其是由提交和 BLA 申請推動的里程碑，我應該說，BLA 申請以及臨床的完成。我們預計臨床工作將在第二季完成。我們也期待著重要的發布。我們在關鍵發布上取得了里程碑式的進展，我們有幾個計劃——顯然，我們在美國和全世界都有一個計劃。但特別是在第二季度，我認為我們預計會報告一些關鍵的臨床完成情況，以及在美國的關鍵推出。

With respect to your last question on COGS, we do not recognize COGS before we recognize revenue. Just as a reminder, when we ship our product to our partners worldwide, at that point, we're recognizing our share of revenue, and it's at that point that we recognize our cost of sales. And I think there was -- yes, go ahead.

關於你關於銷貨成本的最後一個問題，我們在確認收入前不確認銷貨成本。提醒一下，當我們將產品運送給全球合作夥伴時，我們就認識到了我們的收入份額，也正是在那時，我們認識到了我們的銷售成本。我認為——是的，繼續吧。

Sorry, that's very helpful. Maybe just a quick follow-up on biosimilar, Humira. If you can help us frame your expectations of the product and the revenue outlook that you're seeing in the US market and maybe provide better details around the two-tier pricing strategy from Teva and what this means. Thanks.

抱歉，這很有幫助。也許只是生物相似藥 Humira 的快速跟進。如果您可以幫助我們制定您對產品的期望以及您在美國市場看到的收入前景，並可能提供有關 Teva 兩級定價策略及其含義的更好詳細資訊。謝謝。

Thank you, Balaji. Anil speaking. Good to hear your voice again.

謝謝你，巴拉吉。阿尼爾講話。很高興再次聽到你的聲音。

Regarding granularity on the US market, we will not be able to give you exact numbers. But what I can tell you is that, as we said during the prepared remarks, our partner is leading active discussions with the payers. Then the nature of those discussions, I can say, are very positive, and we believe strongly that we will gain broad formulary access. I would say that the official results will, no later than July 1, be available, but we also hope to provide you more color even earlier.

關於美國市場的粒度，我們無法為您提供確切的數字。但我可以告訴你的是，正如我們在準備好的發言中所說，我們的合作夥伴正在與付款人進行積極的討論。我可以說，這些討論的性質是非常積極的，我們堅信我們將獲得廣泛的處方准入。我想說的是，官方結果最遲將在 7 月 1 日公佈，但我們也希望更早為您提供更多資訊。

On the two-tier pricing, that's a very strategic decision that our partner, Teva, took. I will not be able to provide you the details of that. But anyway, you will be seeing this in the public domain very soon as we aim to launch the product in Q2 later.

關於兩級定價，這是我們的合作夥伴 Teva 做出的一個非常具有戰略意義的決定。我無法向您提供詳細資訊。但無論如何，您很快就會在公共領域看到這一點，因為我們的目標是稍後在第二季推出該產品。

Thanks, Anil.

謝謝，阿尼爾。

Carl Byrnes, Northland Capital Markets.

卡爾‧伯恩斯，北國資本市場。

Thanks for the question, and congratulations on the progress in the approval of Simlandi. With respect to Simlandi, and in addition to your prepared comments, how can Teva increase awareness of the interchangeable designation to faster conversion of branded Humira and other biosimilars, particularly during the exclusivity period? Thanks.

感謝您的提問，並祝賀 Simlandi 的審批取得進展。關於 Simlandi，除了您準備好的評論之外，Teva 如何提高人們對可互換名稱的認識，以更快地轉換品牌 Humira 和其他生物仿製藥，特別是在獨佔期內？謝謝。

Thank you very much for the question. First of all, the wind is changing when it comes to interchangeability. We, in our active discussions, see that the payers are more and more appreciating interchangeability. That was a really very positive recognition from our perspective. And secondly, having exclusivity is, of course, giving us a natural advantage in the market space. Teva is -- I know that Teva is very well reminding that to the relevant industry stakeholders.

非常感謝你的提問。首先，互換性方面的風向正在改變。在我們的積極討論中，我們看到付款人越來越欣賞可互換性。從我們的角度來看，這確實是一個非常正面的認可。其次，擁有排他性當然為我們帶來了市場空間的自然優勢。我知道 Teva 很好地向相關產業利害關係人提醒了這一點。

And I think it's also a good opportunity for me to really remind why interchangeability matters. Just as a reminder, we are the first and only high-concentration interchangeable biosimilar to Humira, where approximately 90% of the market is still today on high concentration. And secondly, we, in the market, use this as a differentiation point because this will really be the one of the fundamental advantage of our [text] product profile to move the market in 2024.

我認為這也是一個很好的機會來真正提醒我為什麼可互換性很重要。提醒一下，我們是第一個也是唯一一個與修美樂（Humira）高濃度可互換的生物相似藥，目前大約 90% 的市場仍然處於高濃度狀態。其次，我們在市場上將此作為差異化點，因為這將真正成為我們的 [text] 產品簡介在 2024 年推動市場的基本優勢之一。

And we also showed you more details on our device platform that we believe is another advantage connected to interchangeability. Because we believe interchangeability matters even more with our device platform because our device is really unique and very patient friendly.

我們還向您展示了有關我們設備平台的更多詳細信息，我們認為這是與可互換性相關的另一個優勢。因為我們相信互換性對於我們的設備平台來說更加重要，因為我們的設備非常獨特且非常適合患者。

So all in all, we think that interchangeability is highly appreciated in the market as of now. And we believe this is going to really make Alvotech's and Teva's product, hopefully, the leading biosimilar in the US market.

總而言之，我們認為目前市場上高度重視互換性。我們相信，這將真正使 Alvotech 和 Teva 的產品成為美國市場領先的生物相似藥。

Great. Thanks. That's very helpful.

偉大的。謝謝。這非常有幫助。

Kirsty Ross-Stewart, Citi.

科斯蒂·羅斯·斯圖爾特，花旗銀行。

Hi, thank you. This is Kirsty Ross-Stewart at Citi on for Andrew Baum. Just two questions, please. First, a quick one regarding the pending FDA approval of AVT04, just trying to understand your confidence in approval on April 16 target action date in the US. Specifically, are there any remaining questions on the resolution of the CRL? Or can we assume that the issues will have been addressed given the approval of Simlandi?

嗨，謝謝你。我是花旗銀行安德魯·鮑姆 (Andrew Baum) 的科斯蒂·羅斯·斯圖爾特 (Kirsty Ross-Stewart)。請教你兩個問題。首先，快速介紹一下 AVT04 即將獲得 FDA 批准的情況，只是想了解您對 4 月 16 日美國目標行動日期獲得批准的信心。具體來說，CRL的解決還有什麼問題嗎？或者我們可以假設，如果得到西姆蘭迪的批准，這些問題就會解決？

And second, regarding your future Keytruda biosimilar candidate, do you think Merck's move to a continuous perfusion manufacturing process could result in any regulatory delays to biosimilar launch in light of their recent patent applications, which is suggesting improved shelf life linked to lower oxidation of the product? Thank you.

其次，關於您未來的Keytruda 生物仿製藥候選藥物，您認為默克轉向連續灌注製造工藝是否會導致生物仿製藥上市的監管延遲，因為他們最近的專利申請表明，保質期的延長與生物仿製藥的氧化降低有關。產品？謝謝。

Yeah, thank you for the question. This is Ming, and Anil can take the second part. As far as our AVT04 application, we have high confidence the -- really, the only outstanding hurdle was the inspection. And of course, that's -- as Robert said earlier, it's the same with Simlandi. So we have very high confidence that approval will happen as the inspection status should be clear at this stage. Anil?

是的，謝謝你的提問。這是Ming，Anil可以接第二部。就我們的 AVT04 應用而言，我們非常有信心——實際上，唯一突出的障礙是檢查。當然，正如羅伯特之前所說，西姆蘭迪也是如此。因此，我們對獲得批准非常有信心，因為現階段檢查狀態應該很明確。阿尼爾？

Thank you, Ming. On the Keytruda question, of course, that's a very strategic asset for us, and we are very carefully analyzing all the life cycle moves from the brand company. As you very well know, we have been very successful in doing that in Humira case and a few other assets.

謝謝你，明。當然，在 Keytruda 問題上，這對我們來說是一項非常具有戰略意義的資產，我們正在非常仔細地分析品牌公司的所有生命週期變動。如您所知，我們在 Humira 案例和其他一些資​​產中非常成功地做到了這一點。

So when it comes to continuous perfusion, as you know, Alvotech is one of the few companies who has this technology in-house. We had strategically invested into that technology eight years ago. Even if there is a process change of the product, we would be prepared to do that still in-house. Even if not, we are very carefully monitoring all the life cycle moves from the brand company on that specific asset.

因此，當涉及連續灌注時，如您所知，Alvotech 是少數擁有這種內部技術的公司之一。八年前，我們對這項技術進行了戰略投資。即使產品的製程發生變化，我們也準備在內部進行。即使沒有，我們也會非常仔細地監控品牌公司對該特定資產的所有生命週期變動。

Thank you.

謝謝。

(Operator Instructions) Thibault Boutherin, Morgan Stanley.

（操作員指令）Thibault Boutherin，摩根士丹利。

Hello. Hi, thank you for taking my questions. Just the first one on Humira in the US, thanks for the color that you provided. My question is more specifically on the timeline of inclusion on formularies. Are you confident with the window of opportunity to get on formulary this year in 2024 with an optimal position? Or is it more likely to potentially happen from January 2025?

你好。你好，謝謝你回答我的問題。這是美國 Humira 的第一個，感謝您提供的顏色。我的問題更具體地說是關於列入處方集的時間表。您對 2024 年進入處方集並獲得最佳排名的機會有信心嗎？或從 2025 年 1 月開始更有可能發生？

Second question is on Eylea biosimilar. I'm not sure I heard correctly, but I just wanted to know if you could confirm you think the approval could potentially happen this year. And then if you have any thoughts on the IP situation because we saw some setback from other biosimilar makers on the legal side for Eylea?

第二個問題是關於 Eylea 生物相似藥。我不確定我聽得是否正確，但我只是想知道您是否可以確認您認為今年可能會獲得批准。然後，您是否對智慧財產權狀況有任何想法，因為我們看到其他生物相似藥製造商在 Eylea 的法律方面遇到了一些挫折？

And then the last question is on Stelara interchangeability status, if you could provide us an update on when you think we could see as a steady result for interchangeability. And is it your base case that Amgen could have an exclusivity on this one, and if you could help us on the timeline for exclusivity [in production] as well? Thank you.

最後一個問題是關於 Stelara 可互換性的狀態，您是否可以向我們提供您認為何時可以看到可互換性的穩定結果的最新資訊。您的基本情況是安進可以在該產品上擁有獨家經營權嗎？您是否也可以在[生產]獨家經營的時間表上幫助我們？謝謝。

Thank you, Thibault. Nice to hear from you. So I will take the question one and two. I will hand over the number three to Ming.

謝謝你，蒂博。很高興聽到你的消息。那我將回答問題一和問題二。我會把三號交給小明。

When it comes to US formulary timing, as per our dialogue, we believe that we will be in the formularies by July 1. So we don't see any reason to wait up until January 1. So this is the one.

當涉及美國處方集的時間時，根據我們的對話，我們相信我們將在 7 月 1 日之前進入處方集。因此，我們認為沒有任何理由要等到 1 月 1 日。所以就是這個。

When it comes to second question regarding Eylea biosimilar, we will be filing the product within this year. And of course, we expect the approval before the LOE date in 2025. We are very well aware of the ongoing litigation and various settlement events in global markets. For us, this is an area that we are very active. Teva is very active, as you know, when it comes to litigation and first-to-market opportunities. So we are working on a strategy for that asset to be on market when the LOE happens.

關於 Eylea 生物相似藥的第二個問題，我們將在今年內提交該產品。當然，我們預計在 2025 年 LOE 日期之前獲得批准。我們非常了解全球市場上正在進行的訴訟和各種和解事件。對我們來說，這是一個我們非常活躍的領域。如您所知，梯瓦在訴訟和首次上市機會方面非常活躍。因此，我們正在製定一項策略，以便在 LOE 發生時將該資產投放市場。

Hi, Thibault. It's Ming. Thank you for the question.

嗨，蒂博。是明啊感謝你的提問。

With respect to interchangeability on Stelara, we are seeking interchangeability with Stelara. And I think there's a couple of potential ranges -- potential outcomes. One is that we may have the ability to launch with interchangeable designation, and one, we may be able to -- or would launch shortly after our launch, so in April. And that interpretation is tied to a part of your question, which was Amgen's exclusivity.

關於 Stelara 上的互換性，我們正在尋求與 Stelara 的互換性。我認為有幾個潛在的範圍——潛在的結果。一是我們可能有能力以可互換的名稱推出，一是我們可能能夠——或者將在我們推出後不久推出，所以在四月份。這種解釋與你問題的一部分有關，即安進的排他性。

It will depend on how the FDA views the earlier of clauses in the BPCIA. One would be 18 months after approval or, one, 18 months after the settlement if they tie the litigation and the settlement to the application, which is certainly plausible. I think in our last call, we said shortly after, which is a more conservative date. But obviously, we're watching that closely and would know, but, of course, before our launch, whether or not it could be the more optimistic version, which is launching with interchangeability.

這將取決於 FDA 如何看待 BPCIA 中較早的條款。一是批准後 18 個月，二是和解後 18 個月，如果他們將訴訟和和解與申請聯繫起來，這當然是合理的。我想在我們上次的電話會議中，不久之後我們就說過，這是一個更保守的日期。但顯然，我們正在密切關注這一點，並且會知道，但是，當然，在我們推出之前，它是否可能是更樂觀的版本，即以可互換性推出。

Thank you.

謝謝。

(Operator Instructions) Patrik Ling, DNB Markets.

（操作員指示）Patrik Ling，DNB Markets。

Thank you. Good afternoon. Could I just get a little bit more clarity on your sort of -- if you could walk us through -- from the revenue line down to your guidance for the adjusted EBITDA, given that it's $100 million difference from high -- from low to high in both cases and your milestone indications, at least, from the low to the highest around $80 million. Could you elaborate a little bit on how you see your cost development in the different scenarios, whether you will end up at $50 million in EBITDA or $150 million [there]?

謝謝。午安.我能否更清楚地了解一下您的情況——如果您能引導我們了解一下——從收入線到調整後 EBITDA 的指導，考慮到從低到高的差異為 1 億美元在這兩種情況下，以及您的里程碑跡象，至少從最低到最高約8000 萬美元。您能否詳細說明您如何看待不同情況下的成本發展，無論您最終的 EBITDA 是 5000 萬美元還是 1.5 億美元[那裡]？

Thank you, Patrik. So I'll try my best to describe some of the drivers maybe in arriving at the upper and lower end of our revenue range and guidance range overall.

謝謝你，派崔克。因此，我將盡力描述一些可能達到我們收入範圍和整體指導範圍上限和下限的驅動因素。

So first of all, you know that our revenues are generated from two sources. You have your product revenues, obviously, as we supply our partners, and then you have our milestone revenues as well, which I described. We have several planned for this year, in particular in the second quarter. This is the first time, obviously, that we've had multiple revenue opportunities for launches in multiple markets across the world.

首先，您知道我們的收入來自兩個來源。顯然，當我們向合作夥伴提供產品時，您會獲得產品收入，然後您也會獲得我所描述的里程碑收入。我們今年有幾個計劃，特別是第二季。顯然，這是我們第一次在全球多個市場上推出多種收入機會。

In terms of our launches, we used a range on share and price based on our understanding of where the market is today, as well as feedback from the market overall. On the milestone front, and as we mentioned in the prepared remarks, we have multiple programs. We typically are recognizing milestones when we commence clinical -- when we complete clinical successfully, when we submit.

在我們的發布方面，我們根據對當今市場狀況的了解以及整個市場的反饋，使用了一定的份額和價格範圍。在里程碑方面，正如我們在準備好的發言中提到的，我們有多個計劃。當我們開始臨床時，當我們成功完成臨床時，當我們提交時，我們通常會認識到里程碑。

Also, you have performance-based milestones when we launch. And we also have, as I mentioned earlier, several net sales -- cumulative net sales targets as well that we can also achieve. And so we're planning on achieving several of those, and we see several actually happening in the second quarter, which is creating some of the lumpiness that you see in our overall P&L.

此外，當我們推出時，您將獲得基於績效的里程碑。正如我之前提到的，我們還有幾個淨銷售額——累積淨銷售額目標，我們也可以實現。因此，我們計劃實現其中的一些目標，我們看到第二季度實際上發生了一些目標，這造成了您在我們的整體損益表中看到的一些波動。

So we do have good visibility into our milestones, but there's ultimately still a range of outcomes. And I think you're seeing we're providing our EBITDA range of $50 million to $150 million. We're not providing any more clarity at this point in time. Obviously, this is the first time that we've provided guidance since our listing. But as our business matures, Patrik, we will offer more details with time.

因此，我們確實對里程碑有很好的了解，但最終仍然有一系列結果。我認為您會看到我們提供的 EBITDA 範圍為 5000 萬至 1.5 億美元。目前我們不會提供更多說明。顯然，這是我們自上市以來首次提供指導。但隨著我們業務的成熟，帕特里克，我們將隨著時間的推移提供更多細節。

But would you say that the majority of the difference here is mostly tied to differences in milestones? Or are there any other differences in your expectation when it comes to costs for R&D or COGS or what have you?

但您是否會說這裡的大部分差異主要與里程碑的差異有關？或者，在研發成本或銷貨成本方面，您的預期是否還有其他差異？

I think you have a range, both at milestones and you also have a range at product revenue, throughout the year that you're seeing there. So it's a combination of events.

我認為你有一個範圍，無論是在里程碑上，還是在你所看到的全年產品收入上都有一個範圍。所以這是事件的組合。

But it's mostly revenue driven rather than cost driven, is that a fair assumption?

但這主要是收入驅動而不是成本驅動，這是一個公平的假設嗎？

That is a fair assumption.

這是一個合理的假設。

Okay, great. Good. Thank you.

好的，太好了。好的。謝謝。

Niall Alexander, Deutsche Bank.

尼爾·亞歷山大，德意志銀行。

Hi, it's Niall from Deutsche Bank. Thanks for taking my questions. Guidance given -- so is it fair to assume that for the likes of AVT02 and AVT04, you're implying for FY24 sales of the total revenue? So that's, in other words, $240 million fair? Math is correct -- or can you just clarify what sort of sales split we're going to see between AVT04 and AVT02 FY24 guidance? And then for [FY] guidance, again, can you just be more specific on what sort of split we could potentially see between milestone revenue and actual product sales revenue? Thank you.

大家好，我是德意志銀行的尼爾。感謝您回答我的問題。給予的指引 - 那麼對於 AVT02 和 AVT04 之類的產品，您暗示的是 2024 財年總收入的銷售額是否公平？換句話說，2.4 億美元是公平的嗎？數學是正確的 - 或者您能否澄清我們將在 AVT04 和 AVT02 2024 財政年度指導之間看到什麼樣的銷售分配？然後，對於[FY]指導，您能否更具體地說明我們可能會在里程碑收入和實際產品銷售收入之間看到什麼樣的劃分？謝謝。

Sure. Yeah, so at the top -- thank you so much for your question. Thank you. So first of all, with respect to milestone revenues, the split that we've indicated is anywhere between 40% to 50% of the total revenues that we've guided in the period. So that should be insightful for you both on the high and low end as to how we're thinking about the potential range there.

當然。是的，最上面的——非常感謝你的問題。謝謝。首先，就里程碑收入而言，我們表示的分配比例是我們在此期間指導的總收入的 40% 到 50% 之間。因此，對於我們如何考慮那裡的潛在範圍，這應該對您在高端和低端都有深刻的見解。

To answer your second question, at this point in time, we're not offering a detailed level of guidance in terms of the splits between 02 and 04 in 2024.

為了回答你的第二個問題，目前我們還沒有提供關於 2024 年 02 月和 04 月之間分割的詳細指導。

That was helpful. Thank you.

這很有幫助。謝謝。

The speakers have answered the questions. And I would like now to hand the conference over to Benedikt Stefansson for any closing remarks.

發言人已回答了問題。現在我想將會議交給貝內特史蒂芬森 (Benedikt Stefansson) 發表閉幕詞。

Yes. Thank you, Nadia. And on behalf of the Alvotech team, I'd like to thank all the participants in today's call. I'd like to remind our listeners also that we are, tomorrow, hosting a live webcast from our Capital Markets Day, and you can find further details on our website or investors.alvotech.com.

是的。謝謝你，納迪亞。我謹代表 Alvotech 團隊感謝今天電話會議的所有參與者。我還想提醒我們的聽眾，明天我們將舉辦資本市場日現場網路直播，您可以在我們的網站或 Investors.alvotech.com 上找到更多詳細資訊。

So this ends today's Q4 and full-year 2023 earnings call from Alvotech. Have a nice day.

Alvotech 今天的第四季和 2023 年全年財報電話會議到此結束。祝你今天過得愉快。