Alvotech SA (ALVO) 2023 Q1 法說會逐字稿

Welcome to the First Quarter 2023 Earnings Call for Alvotech. (Operator Instructions) Please be advised that today's conference is being recorded.

歡迎來到 Alvotech 2023 年第一季度財報電話會議。 （操作員說明）請注意，今天的會議正在錄製中。

I would now like to introduce and hand over the call to Benedikt Stefansson, Director of Investor Relations and Global Communications at Alvotech. Please proceed.

我現在想介紹一下並把電話轉給 Alvotech 的投資者關係和全球傳播總監 Benedikt Stefansson。請繼續。

Thank you, and good morning or afternoon to everyone joining us on this call today. The company has issued a press release that can be found on our website, www..alvotech.com. The release reports financial results for the first quarter of 2023 and provide a business update. Additionally, presentation slides that cover our call today have been posted on our investor website. You'll find all materials posted for the Q1 2023 earnings call under News & Events in the Events & Presentations section on investors.alvotech.com.

謝謝，今天加入我們的所有人早上好或下午好。公司已發布新聞稿，可在我們的網站 www..alvotech.com 上找到。該新聞稿報告了 2023 年第一季度的財務業績並提供了業務更新。此外，涵蓋我們今天電話會議的演示幻燈片已發佈在我們的投資者網站上。您可以在 investors.alvotech.com 的“活動與演示”部分的“新聞與活動”下找到為 2023 年第一季度財報電話會議發布的所有材料。

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.

我們的演示材料和我們今天發表的一些聲明可能包含前瞻性聲明。這些陳述不能確保未來的表現，並受公司提交給美國證券交易委員會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所做的前瞻性陳述存在重大差異。

And 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.

和我一起參加今天電話會議的還有 Alvotech 董事長兼首席執行官 Robert Wessman； Anil Okay，首席商務官；喬爾·莫拉萊斯，首席財務官；首席戰略官李明。

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

有了這個，我想把電話轉給羅伯特韋斯曼。

Thank you, Benedikt, and greetings to everyone joining us on the call today. 2023 marks an important year for Alvotech as we celebrate the company's 10 years anniversary. A significant amount of investment over the last decade has allowed us to build the company that includes a vertically integrated biosimilar platform, a vast commercial network and a portfolio of attractive biosimilars and biosimilar candidates that is targeted for global markets. The company is committed to the promise of biosimilars which we believe will provide a long-term benefit to health care systems and patients globally by providing low-cost access to important biologic medicines.

謝謝你，Benedikt，並向今天加入我們電話會議的所有人致以問候。 2023 年對 Alvotech 來說是重要的一年，因為我們慶祝公司成立 10 週年。過去十年的大量投資使我們能夠建立包括垂直整合的生物仿製藥平台、龐大的商業網絡以及針對全球市場的有吸引力的生物仿製藥和候選生物仿製藥的產品組合的公司。公司致力於生物仿製藥的承諾，我們相信生物仿製藥將通過提供低成本的重要生物藥物，為全球醫療保健系統和患者帶來長期利益。

In addition to celebrating our 10 years as a company, we are also approaching our first year anniversary as a publicly listed entity. We are listed on NASDAQ in both the U.S. and in our domestic market of Iceland. And since that time, and as laid out on Page 4 of our presentation, we have continued to drive towards our goal to advance the cause of global biosimilars, by progressing a global portfolio of biosimilar candidates through the development process, expanding our commercial footprint and partnerships, and by driving a number of corporate initiatives that have allowed us to continue to invest in the platform and the pipeline.

除了慶祝公司成立 10 週年外，我們還即將迎來上市公司一周年。我們在美國和冰島國內市場的納斯達克上市。從那時起，正如我們演示文稿第 4 頁所述，我們繼續朝著推進全球生物仿製藥事業的目標前進，方法是在開發過程中推進生物仿製藥候選藥物的全球組合，擴大我們的商業足跡和夥伴關係，並通過推動一些使我們能夠繼續投資於平台和管道的企業計劃。

Alvotech stands as one of the few large pure-play biosimilar companies. Before we discuss the status of AVT02, our proposed high concentration and the interchangeable biosimilar to HUMIRA sold in the U.S. market, I'd like to briefly touch upon sustainability of Alvotech. Our ESG program, which is led by our Board, is a crucial component of our company. We firmly believe that biosimilars are an essential element of global health care sustainability. Biosimilars, not only widen access to biologic medicines, but also stimulate innovation in the life science sector by introducing more cost-effective competition to medicines that account now over 40% of pharmaceutical spending in the U.S. and Europe.

Alvotech 是為數不多的大型純生物仿製藥公司之一。在我們討論 AVT02 的狀態、我們提議的高濃度和在美國市場銷售的 HUMIRA 的可互換生物仿製藥之前，我想簡要談談 Alvotech 的可持續性。我們的 ESG 計劃由董事會領導，是我們公司的重要組成部分。我們堅信生物仿製藥是全球醫療保健可持續性的重要組成部分。生物仿製藥不僅擴大了生物藥物的可及性，而且還通過對目前占美國和歐洲醫藥支出 40% 以上的藥物引入更具成本效益的競爭來刺激生命科學領域的創新。

Further, in any market, the introduction of biosimilars can expand access to many patients that would otherwise not receive biologic treatment, which have become the standard of care across numerous therapies. In alignment with our commitment to sustainability, we have recently disclosed a number of ESG indicators for 2022 that aligned with well-recognized frameworks such as NASDAQ and GRI. The updated disclosure are made available on our website through our sustainability portal.

此外，在任何市場中，生物仿製藥的引入都可以擴大許多原本不會接受生物治療的患者的可及性，這已成為眾多療法的護理標準。為了履行我們對可持續發展的承諾，我們最近披露了一些 2022 年 ESG 指標，這些指標與納斯達克和 GRI 等公認的框架保持一致。更新後的披露信息可通過我們的可持續發展門戶網站在我們的網站上獲取。

And now I would like to spend some time providing the status of our ongoing efforts to gain approval for AVT02 in the U.S. market. AVT02 is seeking to be the first interchangeable and high-concentration biosimilars to HUMIRA. The high-concentration form of adalimumab currently constitute over 85% of the U.S. market today. As many of you know, we have 2 separate applications for the same biosimilar candidate. The first BLA has the data supporting biosimilarity of AVT02 to HUMIRA and the second BLA has the data supporting biosimilarity as well as additional data seeking interchangeability. Both BLA has been reviewed and are deemed approvable, with the only outstanding requirement being a satisfactory site inspection.

現在我想花一些時間介紹一下我們為在美國市場獲得 AVT02 批准所做的持續努力的狀態。 AVT02正在尋求成為 HUMIRA 的第一個可互換的高濃度生物仿製藥。目前，高濃度形式的阿達木單抗占美國市場的 85% 以上。正如你們中的許多人所知，我們有 2 份針對同一候選生物仿製藥的獨立申請。第一個 BLA 具有支持 AVT02 與 HUMIRA 生物相似性的數據，第二個 BLA 具有支持生物相似性的數據以及尋求互換性的其他數據。兩個 BLA 都經過審查並被認為是可批准的，唯一未完成的要求是令人滿意的現場檢查。

Alvotech hosted an inspection that concluded on March 17 of this year. And the company provided substantive response to the 483s on April 3. The biosimilar BLA received a complete response letter from FDA on April 13 of this year, noting only that the deficiency from the recent inspection needed to be resolved. The interchangeable BLA has a goal date of June 28 of this year.

Alvotech 主持了一項於今年 3 月 17 日結束的檢查。並且公司在4月3日對483進行了實質性回應。生物類似藥BLA在今年4月13日收到了FDA的完整回應函，僅指出近期檢查存在的缺陷需要解決。可互換的 BLA 的目標日期是今年 6 月 28 日。

Meanwhile, as we continue to pursue further clarity on potential approval of AVT02 in the U.S., we continue to supply other markets. We have launched AVT02 into 70 markets, including Canada and across Europe without any negative safety signal to date. However, before we can provide specific guidance around our potential U.S. launch timing, we need additional clarity around our application. The first is to understand the status of deficiencies noted in the recently issued FDA 483s, and whether our responses satisfactorily addresses the observations.

與此同時，隨著我們繼續尋求進一步明確 AVT02 在美國的潛在批准，我們繼續供應其他市場。我們已將 AVT02 投放到 70 個市場，包括加拿大和整個歐洲，迄今為止沒有任何負面安全信號。但是，在我們可以就我們在美國的潛在發佈時間提供具體指導之前，我們需要進一步明確我們的應用程序。首先是了解最近發布的 FDA 483 中指出的缺陷的狀態，以及我們的回應是否令人滿意地解決了觀察結果。

The second point of clarification needed, and it is related to the first, is whether our reinspection would be required to gain approval of AVT02 and if such, inspection would be virtual or on-site. Looking forward, in addition to continuing to implement a culture of continuous improvement at our manufacturing sites, we have some tangible next step that we would be undertaking that we believe will allow us to gain further clarity and move forward our goal of bringing AVT02 to the U.S. market.

需要澄清的第二點與第一點相關的是，是否需要我們重新檢查才能獲得 AVT02 的批准，如果是這樣，檢查將是虛擬的還是現場的。展望未來，除了繼續在我們的生產基地實施持續改進的文化外，我們還有一些切實可行的下一步，我們相信這將使我們進一步明確並推進我們將 AVT02 帶到美國市場。

The first is a request to FDA office of pharmaceutical manufacturing assessment to seek for the clarity regarding the status of our deficiencies and clarity regarding our responses, which are intended to address the deficiencies. Further, our responses to the 483 included certain commitments, and we agreed to provide the FDA with monthly updates on the progress of these commitments. This was done on May 1 of this year, and we intend to provide another one on June 1, which, in our view, will complete outstanding corrective and preventive actions that we were committed to.

首先是向 FDA 藥品製造評估辦公室提出要求，要求澄清我們的缺陷狀況和我們旨在解決缺陷的響應的清晰度。此外，我們對 483 的回應包括某些承諾，我們同意每月向 FDA 提供這些承諾進展情況的最新信息。這是在今年 5 月 1 日完成的，我們打算在 6 月 1 日提供另一個，我們認為這將完成我們承諾的未完成的糾正和預防措施。

Subsequent to that, the company intends, as a matter of procedure, to resubmit the biosimilar BLA, which would trigger a 6-month review period that would be needed in case approval is not granted on June 28, which, again, is the goal date for the interchangeable BLA.

此後，公司打算按照程序重新提交生物仿製藥 BLA，這將觸發為期 6 個月的審查期，以防 6 月 28 日未獲得批准，這也是我們的目標可互換 BLA 的日期。

The company remains committed to bringing AVT02 to patients in the U.S. as soon as possible, and we believe that our product profile matches the current needs of the market. We believe that high concentration, combined with interchangeability for a HUMIRA biosimilar is necessary to convert the market effectively, especially during the time where the originator remains on formulary.

公司仍然致力於盡快將 AVT02帶給美國患者，我們相信我們的產品概況符合當前市場需求。我們認為，HUMIRA 生物仿製藥的高濃度和可互換性是有效轉換市場所必需的，尤其是在原研藥仍保留在處方集期間。

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.

因此，我想將演示文稿轉交給我們的首席商務官 Anil Okay，以介紹我們的管道並提供商業更新。交給你了，阿尼爾。

Thank you, Robert. I will start by providing a broader update on our disclosed pipeline. Of course, as a company that develops products from scratch, we do maintain an active list of early development targets within R&D. And we do expect to add more products over time as our disclosed pipeline continues to progress.

謝謝你，羅伯特。我將首先對我們披露的管道提供更廣泛的更新。當然，作為一家從零開始開發產品的公司，我們確實在研發中保留了一份早期開發目標的活動列表。隨著我們披露的管道繼續取得進展，我們確實希望隨著時間的推移添加更多產品。

Firstly, we are pleased to announce that we have initiated patient studies for AVT05, a biosimilar candidate to SIMPONI and SIMPONI ARIA. AVT05 was developed using a murine cell line and utilizes a perfusion production process. This is similar to AVT04, our proposed biosimilar to STELARA. On AVT05, we are currently aware of only one other company that has a clinical-stage asset for a biosimilar to SIMPONI, and we are the only company with a clinical-stage asset for golimumab that has launched biosimilars in multiple global markets.

首先，我們很高興地宣布，我們已經啟動了 AVT05 的患者研究，AVT05 是 SIMPONI 和 SIMPONI ARIA 的候選生物仿製藥。 AVT05 是使用小鼠細胞系開發的，並採用灌註生產工藝。這類似於 AVT04，我們提出的 STELARA 生物仿製藥。在 AVT05 上，我們目前知道只有一家公司擁有 SIMPONI 的生物仿製藥臨床階段資產，我們是唯一一家擁有 golimumab 臨床階段資產並在多個全球市場推出生物仿製藥的公司。

Worldwide revenues of SIMPONI and SIMPONI ARIA exceeded USD 2 billion in 2022. Initiation of patient studies for AVT05 represents the fifth product to reach this stage in our portfolio, which demonstrates the development capabilities of our biosimilar platform. Included in this group of products is, of course, AVT02, which has begun commercialization in a number of markets, including Canada and Europe, and AVT04, a biosimilar candidate to STELARA, which is filed in major markets globally, including Japan, U.S., Europe, and Canada.

SIMPONI 和 SIMPONI ARIA 的全球收入在 2022 年超過 20 億美元。AVT05 的患者研究啟動是我們產品組合中第五個達到這一階段的產品，這證明了我們生物仿製藥平台的開發能力。當然，這組產品中包括已在加拿大和歐洲等多個市場開始商業化的 AVT02，以及已在全球主要市場（包括日本、美國、歐洲、加拿大。

On this call, we would also like to provide updates and unveil 2 previously undisclosed pipeline opportunities. The first of which is AVT16, a biosimilar candidate to ENTYVIO, which is a leading immunology product with over USD 5 billion in global sales in 2022 and has shown significant growth since the product's launch. Current analyst estimates view the growth potential for the brand to exceed USD 8 billion. We have developed our biosimilar to the stage of at-scale manufacturing and hope to provide further updates as the development program progresses.

在這次電話會議上，我們還想提供更新並公佈 2 個以前未公開的管道機會。第一個是 AVT16，它是 ENTYVIO 的生物仿製藥候選藥物，是領先的免疫學產品，2022 年全球銷售額超過 50 億美元，自產品推出以來已顯示出顯著增長。目前分析師估計該品牌的增長潛力超過 80 億美元。我們已經將我們的生物仿製藥開發到大規模生產階段，並希望隨著開發計劃的進展提供進一步的更新。

The next previously undisclosed biosimilar candidate is AVT33, which is a proposed biosimilar to KEYTRUDA, a leading oncology product. With worldwide sales in 2022 of over USD 20 billion, KEYTRUDA is in the top 5 products globally in terms of revenue. AVT33 is our first disclosed product in the oncology space, which is an area we intend to expand further into as we continue to build our pipeline. The program has completed our clone selection phase. And again, we look forward to providing updates on this exciting opportunity going forward.

下一個先前未公開的生物仿製藥候選藥物是 AVT33，它是針對領先的腫瘤學產品 KEYTRUDA 的擬議生物仿製藥。 KEYTRUDA 在 2022 年的全球銷售額超過 200 億美元，在收入方面位居全球前 5 名。 AVT33是我們在腫瘤學領域公開的第一個產品，隨著我們繼續建立我們的產品線，我們打算進一步擴展該領域。該程序已經完成了我們的克隆選擇階段。再一次，我們期待提供有關這一激動人心的機會的最新信息。

As mentioned in our press release yesterday evening, and in accordance with our contractual rights, we have provided BiosanaPharma a Notice of Termination for the global licensing agreement between the 2 companies covering AVT23, our proposed biosimilar to XOLAIR. We are currently evaluating alternative options for the program and intend to provide further updates as we finalize the strategy. AVT23 was our first proposed biosimilar that was not developed in-house, and it is also important to note that based on the timing of the licensing agreement, potential revenues from AVT23 were not included in the long-term forecasts provided during Alvotech's first Analyst Day as part of the company's spec process.

正如我們昨天晚上的新聞稿中提到的，根據我們的合同權利，我們已經向 BiosanaPharma 提供了兩家公司之間的全球許可協議的終止通知，涉及 AVT23，我們提議的 XOLAIR 生物仿製藥。我們目前正在評估該計劃的替代方案，並打算在我們最終確定戰略時提供進一步的更新。 AVT23 是我們提出的第一個非內部開發的生物仿製藥，同樣重要的是要注意，根據許可協議的時間安排，AVT23 的潛在收入不包括在 Alvotech 的第一個分析師日提供的長期預測中作為公司規格流程的一部分。

On the commercial front, Alvotech continues to make strides in our partnership network and our launches. As a reminder, Alvotech is a B2B model that generates revenues through substantial milestone payments from our commercial partners as well as revenue sharing after launch that provides us with approximately 40% of net sales in any particular region. Since the start of the year, we have expanded or added partnerships in various markets around the world, including Japan and Turkey. And we continue to maintain a robust pipeline of business development opportunities similar to our existing arrangements for unlicensed pipeline candidates that are both disclosed and undisclosed.

在商業方面，Alvotech 繼續在我們的合作夥伴網絡和產品發布方面取得長足進步。提醒一下，Alvotech 是一種 B2B 模式，它通過我們的商業合作夥伴的大量里程碑付款以及發布後的收入分享來產生收入，這為我們在任何特定地區提供了大約 40% 的淨銷售額。自今年年初以來，我們在全球各個市場（包括日本和土耳其）擴大或增加了合作夥伴關係。我們將繼續保持強大的業務發展機會渠道，類似於我們現有的已披露和未披露的未獲許可渠道候選人的安排。

We truly believe in this model for the long term as the best way to leverage our platform and to create value and growth going forward. As of today, we have 18 distinct partners covering over 90 markets for our portfolio and pipeline. We continue to work with our partners to progress launches for AVT02, our biosimilar to HUMIRA, in Canada and in Europe, where we have launched in 17 markets to date. In 2023, we are planning for an additional 7 launches in various markets for AVT02, where we are already in the pricing and reimbursement stage in various geographies. Big number at the moment excludes U.S. market until we have further clarity on regulatory timing.

從長遠來看，我們堅信這種模式是利用我們的平台並創造價值和推動未來增長的最佳方式。截至今天，我們擁有 18 個不同的合作夥伴，覆蓋 90 多個市場的產品組合和渠道。我們繼續與我們的合作夥伴合作，推進 AVT02 的上市，我們的 HUMIRA 生物仿製藥在加拿大和歐洲上市，迄今為止我們已在 17 個市場上市。 2023 年，我們計劃在各個市場再推出 7 個 AVT02，我們已經在各個地區處於定價和報銷階段。在我們進一步明確監管時機之前，目前的大數字不包括美國市場。

Additionally, we are already making commercial preparations and have received purchase orders for AVT04, our biosimilar candidate for STELARA for various markets. We believe we were the first to submit this product in a number of key markets and anticipate being in a strong position to compete globally in ustekinumab, which has an addressable market approaching USD 10 billion. We are working with our partners to launch our proposed biosimilar at the earliest possible date.

此外，我們已經在進行商業準備，並已收到 AVT04 的採購訂單，AVT04 是我們針對不同市場的 STELARA 生物仿製藥候選藥物。我們相信我們是第一個在多個關鍵市場提交該產品的公司，並預計在 ustekinumab 的全球競爭中處於有利地位，該市場的潛在市場接近 100 億美元。我們正在與我們的合作夥伴合作，以儘早推出我們提議的生物仿製藥。

And with that, I would like to hand the presentation over to our CFO, Joel Morales.

因此，我想將演示文稿交給我們的首席財務官 Joel Morales。

Thanks, Anil. I'll now provide some brief financial highlights for the period ending March 31, 2023.

謝謝，阿尼爾。我現在將提供一些截至 2023 年 3 月 31 日期間的簡要財務摘要。

In our previous earnings call in March, we reported that during the first quarter, we had closed on a private placement with Icelandic investors of approximately $137 million in gross proceeds. In addition, during the quarter, we collected the remaining proceeds of approximately $14 million from our convertible bond issuance, which we initiated last December. With this financing activity now completed, we ended the first quarter with approximately $116 million cash on hand as of March 31, excluding restricted cash of $25 million.

在我們 3 月份的上一次財報電話會議上，我們報告說，在第一季度，我們已經結束了與冰島投資者的私人配售，總收益約為 1.37 億美元。此外，在本季度，我們從去年 12 月發起的可轉換債券發行中籌集了大約 1400 萬美元的剩餘收益。隨著這項融資活動現已完成，截至 3 月 31 日，我們在第一季度結束時手頭現金約為 1.16 億美元，不包括 2500 萬美元的受限制現金。

In terms of our operating performance, the company recorded $16 million in total revenue for the first quarter of 2023 versus $1 million during the same period in the prior year. This sharp increase is driven by our first launch in the prior year, which meaningfully commenced in the second quarter of 2022. There were no milestone revenues recognized in the period given the timing of our performance-based licensing and R&D milestones. We expect to recognize most of our milestone and licensing revenue in the second half of 2023.

就我們的經營業績而言，公司 2023 年第一季度的總收入為 1600 萬美元，而去年同期為 100 萬美元。這一急劇增長是由我們去年的首次發布推動的，該發布有意義地在 2022 年第二季度開始。鑑於我們基於性能的許可和研發里程碑的時間安排，在此期間沒有確認里程碑收入。我們預計將在 2023 年下半年確認我們的大部分里程碑和許可收入。

A point worthwhile noting is that cost of product revenue for the quarter is disproportionate relative to product revenue due to the timing of new launches and elevated production-related charges resulting in higher costs than revenues recognized for the period. We do expect this to normalize as we increase scale of manufacturing and expand 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.

值得注意的一點是，本季度產品收入成本與產品收入不成比例，原因是新產品發布的時間和與生產相關的費用增加導致成本高於當期確認的收入。我們確實希望隨著我們增加製造規模和擴大發布範圍，這種情況會正常化。我們預計銷量的增加將對產品收入成本產生有利影響，尤其是在我們增加固定成本吸收的情況下。

As a reminder, at this juncture, we are planning to wait to provide our 2023 financial guidance until after we have further clarity from the FDA on the potential approval of AVT02 and the impact on the timing of commercial contracting.

提醒一下，此時此刻，我們計劃等到 FDA 進一步明確 AVT02 的潛在批准以及對商業合同時間的影響後，再提供我們的 2023 年財務指導。

In terms of near-term liquidity, given the lack of clarity regarding the exact timing of the potential approval of AVT02, we have begun to explore options to raise further capital so that we can continue advancing our pipeline over the near term with the goal of obtaining approval for and launching all of our programs in the U.S. and rest of world over time. While we remain focused on driving towards a positive outcome with the FDA, we are preparing for potential scenarios that may impact our previously communicated time lines. We will keep you updated on any developments at the appropriate time. Until then, you can expect that we will continue to expand our launch of AVT02 into more markets, and expect shipments to our commercial partners to increase in the second half of the year.

在短期流動性方面，鑑於 AVT02 可能獲得批准的確切時間尚不明確，我們已開始探索籌集更多資金的方案，以便我們可以在短期內繼續推進我們的產品線，目標是隨著時間的推移，獲得批准並在美國和世界其他地區啟動我們的所有計劃。雖然我們仍然專注於推動與 FDA 取得積極成果，但我們正在為可能影響我們之前溝通的時間表的潛在情況做準備。我們會在適當的時候讓您了解任何最新進展。在那之前，您可以預期我們將繼續將 AVT02 的發布擴展到更多市場，並預計下半年對我們商業合作夥伴的出貨量將會增加。

As highlighted to you in the past, we are currently increasing scale for our AVT02 manufacturing process to support these launches as well as new launches that we are anticipating later this year, including in the U.S. Our prelaunch preparations will result in a build of inventory, which we expect to continue through the first half of this year.

正如過去向您強調的那樣，我們目前正在擴大 AVT02 製造工藝的規模，以支持這些發布以及我們預計今年晚些時候推出的新產品，包括在美國。我們的發布前準備工作將導致庫存增加，我們預計這將持續到今年上半年。

And finally, we closed the period with 263.5 million shares outstanding, including unvested earnout shares.

最後，我們以 2.635 億股流通股結束了這一時期，其中包括未歸屬的盈利股票。

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

有了這個，我想把電話轉回給接線員進行問答。

(Operator Instructions) we will take our first question, and the question comes from the line of Andrew Baum from Citigroup.

（操作員說明）我們將提出第一個問題，這個問題來自花旗集團的安德魯鮑姆。

A couple of questions. First, in light of the FDA's inspection and the measures you've put in place to address their concerns, I'm assuming STELARA is manufactured at the same site. Is there any need to amend your filing or put in place additional remediation measures to ensure the U.S. approval? And then, second, I'd be curious if you have any thoughts on the impact to your future development given the denial of Teva's addition to the Supreme Court in relation to Coreg versus Avandia. It would seem that skinny labels are going to be somewhat more problematic in future unlike the [vivid] cases with your existing portfolios that may make prosecution of the U.S. (inaudible)?

幾個問題。首先，根據 FDA 的檢查和您為解決他們的擔憂而採取的措施，我假設 STELARA 是在同一地點生產的。是否需要修改您的文件或採取額外的補救措施以確保獲得美國批准？然後，第二，我很好奇你是否對你未來發展的影響有任何想法，因為 Teva 被拒絕加入最高法院與 Coreg 和文迪雅的關係。與您現有投資組合的 [vivid] 案件可能會起訴美國（聽不清）不同，瘦標籤在未來似乎會出現更多問題？

Thank you, Andrew. Robert Wessman here. We have a BsUFA date on 11th of October for our AVT04. And we have -- as we said, we -- even though it's produced at the same manufacturing facility, we still believe we have a pretty good and sufficient time to resolve that.

謝謝你，安德魯。羅伯特韋斯曼在這裡。我們的 AVT04 的 BsUFA 日期為 10 月 11 日。而且我們 - 正如我們所說，我們 - 即使它是在同一個製造工廠生產的，我們仍然相信我們有足夠的時間來解決這個問題。

Coming to AVT02, there is not a clarity yet, and that has been confirmed by FDA, but they have not taken a decision whether a reinspection is needed or not. And that's why, as I said in my intro, we are seeking a meeting for -- with OPMA, which basically is via a recommendation from FDA to seek clarity if they have finalized to review our responses, if they are (inaudible), and if inspection or reinspection is needed or not, in which kind of a format that would be.

至於AVT02，目前還沒有一個明確的說法，已經得到了FDA的確認，但他們還沒有決定是否需要復檢。這就是為什麼，正如我在介紹中所說，我們正在尋求與 OPMA 的會議，這基本上是通過 FDA 的建議來尋求澄清，如果他們已經完成審查我們的回應，如果他們是（聽不清），並且是否需要檢驗或複檢，採用何種形式。

The second question to -- goes to Anil.

第二個問題交給Anil。

Andrew, I can take the second question. We are aware of the Supreme Court decision. We would not believe that this impacts neither our portfolio or launch decisions in the U.S. market.

安德魯，我可以回答第二個問題。我們知道最高法院的決定。我們認為這不會影響我們在美國市場的投資組合或發布決策。

We will take our next question. Your next question comes from the line of Thibault Boutherin from Morgan Stanley.

我們將回答下一個問題。你的下一個問題來自摩根士丹利的 Thibault Boutherin。

A couple on HUMIRA biosimilar. First, do you have any -- can you give any indication on your expected timing for the meeting with the FDA? And second question, just to clarify, if you have to actually resubmit BLA after the 28th of June, will it necessarily be resubmission of the original BLA? Or could you potentially, at that time, already resubmit a BLA with interchangeability?

一對夫婦在使用 HUMIRA 生物仿製藥。首先，你有什麼——你能給出任何關於你與 FDA 會面的預期時間的指示嗎？第二個問題，澄清一下，如果您必須在 6 月 28 日之後實際重新提交 BLA，是否一定要重新提交原始 BLA？或者您當時是否有可能已經重新提交具有可互換性的 BLA？

Robert Wessman here. So basically, we would assume, as we have done in the past, that we will resubmit our biosimilar BLA. We will do that once we have completed the commitments towards FDA, which -- towards the manufacturing and supply deficiencies, and we assume to close them all, 1st of June. We will then resubmit and we would then go for a 6-month clock, which most likely would then give us, or would give a BsUFA date 6 months later. And within that time frame, of course, FDA would then decide if a reinspection is needed or not if that is not already clear at that time. So that's the framework.

羅伯特韋斯曼在這裡。所以基本上，我們會假設，就像我們過去所做的那樣，我們將重新提交我們的生物仿製藥 BLA。一旦我們完成了對 FDA 的承諾，我們將這樣做——針對製造和供應缺陷，我們假設在 6 月 1 日將它們全部關閉。然後我們將重新提交，然後我們會選擇 6 個月的時鐘，這很可能會給我們，或者會在 6 個月後給出 BsUFA 日期。當然，在那個時間範圍內，如果當時還不清楚，FDA 將決定是否需要重新檢查。這就是框架。

And the second part of the question...

問題的第二部分......

Well, the first part of the question, I think, was -- Thibault, was about the potential meeting timing. I think unlike a type 1, there's no defined process, but we are engaging and already working on schedule process for that. So we don't have a defined date, but we believe it will be 30 days or less. That's our assumption.

嗯，我認為問題的第一部分是-- Thibault，是關於可能的會議時間。我認為與類型 1 不同的是，它沒有明確的流程，但我們正在參與並已經在為此制定計劃流程。所以我們沒有確定的日期，但我們相信會在 30 天或更短時間內完成。這是我們的假設。

We will take our next question, and the question comes from the line of Ashish Verma from UBS.

我們將回答下一個問題，這個問題來自瑞銀的 Ashish Verma。

I have a few. So first one, just on biosimilar HUMIRA. I wanted to understand a little bit like what is the nature of observations that you received from the FDA this time? Are the previous observations -- I think you mentioned in previous conversation that there were no repeat observations. So are the previous observations completely resolved?

我有幾個。所以第一個，關於生物仿製藥 HUMIRA。我想了解一下您這次從 FDA 收到的觀察結果的性質是什麼？是之前的觀察嗎？我想你在之前的談話中提到沒有重複觀察。那麼之前的觀察是不是就徹底解決了呢？

Second one, on STELARA, do you have freedom to operate in this market? Or does it still need to go through litigation with J&J? I'm just curious, I think from the perspective of interchangeability, do you think this matters for STELARA, and your reason for not pursuing it at this stage.

第二個，在STELARA上，你們在這個市場上有經營的自由嗎？還是還需要跟強生打官司？我只是好奇，我覺得從互換性的角度來看，你認為這對STELARA重要嗎，以及你現階段不追求它的原因。

And then finally, a third one that I had was on KEYTRUDA biosimilar. This can be a huge market. I think what I wanted to understand was that is there anything unique or fundamentally unique to the PD-1 design of the palindrome molecule that may not lend itself well to a biosimilar market? Like we have seen competing PD-1 OPDIVO not able to show the same level of clinical results as KEYTRUDA. So is there something unique about KEYTRUDA that a biosimilar studies might not be able to replicate the same level of clinical efficacy?

最後，我擁有的第三個是 KEYTRUDA 生物仿製藥。這可能是一個巨大的市場。我想我想了解的是，回文分子的 PD-1 設計是否有任何獨特之處或根本獨特之處可能不適用於生物仿製藥市場？就像我們看到競爭性 PD-1 OPDIVO 無法顯示與 KEYTRUDA 相同水平的臨床結果。那麼 KEYTRUDA 是否有一些獨特之處，以至於生物仿製藥研究可能無法複製相同水平的臨床療效？

This is Ming. Thank you for the question. Maybe I'll answer the different order and I'll pass it over to Anil. From the previous inspection, which, of course, was in March of '22, there were no repeat observations. I think that's an important -- good question and an important thing to note.

這是明感謝你的提問。也許我會回答不同的命令，然後將其傳遞給 Anil。從之前的檢查來看，當然是在 22 年 3 月，沒有重複觀察。我認為這是一個重要的問題——很好的問題，也是需要注意的重要事項。

So the observations that were provided in the '23 -- March '23 inspection, you asked about the nature of them. I would say that most of them were around the quality system and the quality units. The nature of the observations I would describe as more pointing to upstream, call them upstream observations rather than downstream problems. I think that 483 is public. We have -- but the responses to those are not public.

所以在 '23 - 23 年 3 月檢查中提供的觀察結果，你詢問了它們的性質。我會說他們中的大多數都圍繞著質量體系和質量單位。我將描述的觀察的性質更多地指向上游，稱它們為上游觀察而不是下游問題。我認為 483 是公開的。我們有——但對這些的回應並未公開。

And the way we approach them was to try to address those specifically, but also do it at a macro level and changes in our overall organization and things of that nature as well as where applicable, to do retrospective analysis to ensure that these downstream problems didn't exist historically. As you know, we currently manufacture commercially, of course, not for the U.S., but for other places. So there's this history there.

我們處理這些問題的方法是嘗試具體解決這些問題，但也在宏觀層面上進行，改變我們的整體組織和類似性質的事物，以及在適用的情況下進行回顧性分析，以確保這些下游問題沒有發生歷史上存在。如您所知，我們目前的商業生產當然不是針對美國，而是針對其他地方。所以那裡有這段歷史。

On the 04 questions, let me pass that to Anil.

關於 04 的問題，讓我將其傳遞給 Anil。

Thanks, Ming. Ashish, when it comes to AVT04 question, of course, we cannot comment on that. We cannot give guidance on that. So I will pass that question. But when it comes to interchangeability, we have not made a final decision on pursuing interchangeability for AVT04 as of yet. The regional set is actually related with the product profile. The product does not have the same regional profile as HUMIRA, and it is those infrequencies compared to HUMIRA, and the level of competition in comparison is much more low. Because of those reasons, we have not initiated yet, but we also still potentially can consider if we want.

謝謝，明。 Ashish，關於 AVT04 問題，我們當然不能對此發表評論。我們無法就此提供指導。所以我會通過這個問題。但在互換性方面，我們目前還沒有最終決定是否追求 AVT04 的互換性。區域集其實是跟產品簡介相關的。該產品不具有與 HUMIRA 相同的區域概況，與 HUMIRA 相比是那些不常見的地方，相比之下競爭水平要低得多。由於這些原因，我們還沒有啟動，但如果我們願意，我們仍然有可能考慮。

On your third question regarding KEYTRUDA and -- let me start with the efficacy part. Of course, this is no different than ustekinumab or trastuzumab biosimilars, which has seen over 70% penetration across the world. So we expect the same with the KAYTRUDA biosimilars. When it comes to efficacy, these are -- biosimilars are efficacious products. So that's point one. When it comes to study design, we are working with authorities globally, both in the U.S., Europe, Japan, the global authorities in the design phase of our studies. Of course, we get there, advise them, and consult with them and jointly design our clinical product. Thank you.

關於你關於 KEYTRUDA 的第三個問題——讓我從功效部分開始。當然，這與 ustekinumab 或 trastuzumab 生物仿製藥沒有什麼不同，後者在全球的滲透率已超過 70%。因此，我們期望 KAYTRUDA 生物仿製藥也能如此。說到功效，這些是——生物仿製藥是有效的產品。所以這是第一點。在研究設計方面，我們正在與全球權威機構合作，包括美國、歐洲、日本，以及我們研究設計階段的全球權威機構。當然，我們到達那裡，向他們提供建議，並與他們協商並共同設計我們的臨床產品。謝謝。

We will take our next question, your next question comes from the line of Carl Byrnes from Northland Capital Markets.

我們將回答下一個問題，您的下一個問題來自 Northland Capital Markets 的 Carl Byrnes。

Apologies if I missed this. But if the FDA does not require reinspection of the facility, when would be the earliest that you'd be made aware of that? And conversely, if they do require reinspection, when would be the earliest you'd be made aware of that?

如果我錯過了這個，我深表歉意。但是，如果 FDA 不要求對設施進行重新檢查，那麼您最早什麼時候會知道這一點？相反，如果他們確實需要重新檢查，那麼您最早會在什麼時候知道這一點？

Thank you for that question. Robert Wessman, here. So we are working, of course, with the FDA. They have said that they are not going to take any earlier action, which means that 28 is the date, which we would either understand that we got approval, potentially would be the day we understand then that reinspection is needed. But we would then still want to highlight that we are still hopeful with the meeting with OPMA, which we are scheduling, as Ming mentioned earlier, and we are in interaction with the FDA on specific questions they have. And we hope to get the clarity out of that meeting, if you will. So I would say, in the worst case, we would learn this 28, but of course, we are still hopeful that we can understand this sooner than that.

謝謝你提出這個問題。羅伯特·韋斯曼，在這裡。所以我們當然在與 FDA 合作。他們說他們不會提前採取任何行動，這意味著 28 日是我們了解我們獲得批准的日期，可能是我們了解需要重新檢查的日期。但我們仍然想強調，我們仍然對與 OPMA 的會議充滿希望，正如 Ming 之前提到的，我們正在安排會議，我們正在與 FDA 就他們提出的具體問題進行互動。如果您願意的話，我們希望從那次會議中得到澄清。所以我想說，在最壞的情況下，我們會學習這個 28，但當然，我們仍然希望我們能早點理解這個。

There seems to be no further questions. So I would like to hand back to Robert Wessman for closing remarks.

似乎沒有進一步的問題。所以我想把結束語交還給羅伯特韋斯曼。

Actually, Benedikt Stefansson here. Thank you, Heidi. On behalf of the Alvotech team, I would like to thank everybody who participated today, and we wish you a good rest of the day and look forward to speaking to you all again. Thanks.

實際上，這裡有 Benedikt Stefansson。謝謝你，海蒂。我代表 Alvotech 團隊，感謝今天參加的每一個人，祝大家今天休息愉快，期待與大家再次交談。謝謝。

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

今天的電話會議到此結束。感謝您的參與。您現在可以斷開連接。