Alvotech SA (ALVO) 2022 Q4 法說會逐字稿

Welcome to the fourth quarter earnings call for Alvotech. (Operator Instructions) Please be advised that today's conference is being recorded.

歡迎來到 Alvotech 第四季度財報電話會議。 （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 this call today.

謝謝大家，今天參加這個電話會議的每個人早上好或下午好。

Yesterday evening, the company issued a press release that can be found on our website, investors.alvotech.com, under News and Events in the Events and Presentations section. The press release reports financial results for fiscal year 2022 and provides a business update.

昨天晚上，公司發布了一份新聞稿，可以在我們的網站 investors.alvotech.com 的“新聞和事件”下的“活動和演示”部分找到。該新聞稿報告了 2022 財年的財務業績並提供了業務更新。

Additionally, presentation slides that cover our call today will be posted on our website at investors.alvotech.com. Please look under News and Events for the Events and Presentations section.

此外，涵蓋我們今天電話會議的演示幻燈片將發佈在我們的網站 investors.alvotech.com 上。請查看新聞和活動下的活動和演示部分。

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, including in our Annual Report on Form 20-F for the fiscal year ending December 31, 2022. 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，包括我們截至 2022 年 12 月 31 日的財政年度的 20-F 表格年度報告。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。

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

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

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 welcome, everyone, to our fourth quarter and full year 2022 update call.

謝謝 Benedikt，歡迎大家參加我們的第四季度和 2022 年全年更新電話會議。

As you know, I have recently been appointed as a Chief Executive Officer for Alvotech. I see this as a seamless extension of my role as Executive Chairman. I'm excited to take on this new challenge, and continue to drive Alvotech's growth and success in the global biosimilar markets.

如您所知，我最近被任命為 Alvotech 的首席執行官。我認為這是我作為執行主席角色的無縫延伸。我很高興接受這一新挑戰，並繼續推動 Alvotech 在全球生物仿製藥市場的發展和成功。

I'm also thrilled to welcome Hafrun Fridriksdottir to Alvotech as our Chief Operating Officer. Hafrun brings a wealth of experience in the pharmaceutical industry, most recently at Teva Pharmaceuticals.

我也很高興歡迎 Hafrun Fridriksdottir 加入 Alvotech，擔任我們的首席運營官。 Hafrun 帶來了製藥行業的豐富經驗，最近一次是在 Teva Pharmaceuticals。

Before we move to our business update, I want again to reinforce Alvotech core competence. Alvotech is a pure-play biosimilar platform. I believe that we have the infrastructure, the personnel, the processes and the dedication it takes to be successful in the biosimilar space.

在我們進行業務更新之前，我想再次加強 Alvotech 的核心競爭力。 Alvotech 是一個純粹的生物仿製藥平台。我相信我們擁有在生物仿製藥領域取得成功所需的基礎設施、人員、流程和奉獻精神。

Alvotech also takes a multiproduct approach with the portfolio and pipeline that currently includes 8 biosimilar and biosimilar candidates. We plan to expand our offering in this area by leveraging our platform's capacity as we progress candidates through the approval process.

Alvotech 還採用多產品方法，其產品組合和管道目前包括 8 種生物仿製藥和候選生物仿製藥。我們計劃通過利用我們平台的能力來擴大我們在這一領域的產品，因為我們通過批准流程推進候選人。

And finally, Alvotech has commercial partnership with top-tier partners covering over 90 markets. We have started to commercialize our first biosimilar in 17 markets, including Canada and markets across Europe. We believe that Alvotech's global approach will further enhance our top line growth going forward. At the same time, it will provide scale and flexibility to Alvotech by marketing the same products worldwide.

最後，Alvotech 與覆蓋 90 多個市場的頂級合作夥伴建立了商業合作夥伴關係。我們已開始在 17 個市場（包括加拿大和整個歐洲市場）將我們的第一個生物仿製藥商業化。我們相信 Alvotech 的全球策略將進一步促進我們未來的收入增長。同時，它將通過在全球範圍內營銷相同的產品，為 Alvotech 提供規模和靈活性。

And with that, let us go through some of the highlights of 2022, which was a very meaningful year in our journey.

因此，讓我們回顧一下 2022 年的一些亮點，這是我們旅程中非常有意義的一年。

Firstly, we were able to meet the lower end of our top line guidance that we presented in our first Analyst Day as a part of our [back] process. It's also important to note that the revenue growth was achieved while investing in the future through the growth of our pipeline. Alvotech have been able to secure July 1 launch date in the U.S. for our biosimilar candidate to HUMIRA. We expect that the AVT02 can be the first and only high-concentration interchangeable biosimilar adalimumab on the market for at least 12 months. Of course, this requires approval, but if satisfactory, the inspection of our manufacturing facility remains the only outstanding item. FDA is expected to begin on March 6 their inspection of our facility in Iceland.

首先，作為我們 [返回] 流程的一部分，我們能夠達到我們在第一個分析師日提出的最高指導方針的下限。同樣重要的是要注意，收入增長是在通過我們管道的增長對未來進行投資的同時實現的。 Alvotech 已經能夠確保 7 月 1 日在美國推出我們的 HUMIRA 候選生物仿製藥。我們預計 AVT02 可以成為市場上第一個也是唯一一個高濃度可互換生物類似藥阿達木單抗至少 12 個月。當然，這需要獲得批准，但如果令人滿意，對我們製造設施的檢查仍然是唯一未完成的項目。預計 FDA 將於 3 月 6 日開始檢查我們在冰島的設施。

This past January, the team hosted the EMA inspection that resulted in EU GMP recertification. Collectively, we equally anticipate the forthcoming FDA inspection and are grateful for the agency's commitment to a timely reinspection.

今年 1 月，該團隊主持了 EMA 檢查，該檢查導致歐盟 GMP 重新認證。總的來說，我們同樣期待即將到來的 FDA 檢查，並感謝該機構對及時重新檢查的承諾。

We also have submitted marketing applications for our proposed biosimilar to STELARA in our major markets, including U.S. and EU. Both applications have now been accepted by the respective regulatory authorities.

我們還在我們的主要市場（包括美國和歐盟）提交了我們擬議的 STELARA 生物仿製藥的營銷申請。這兩項申請現已被各自的監管機構接受。

Further, we have moved 3 proposed biosimilar into clinical stage development. These are the biosimilar candidates for EYLEA, Prolia and XGEVA and SIMPONI.

此外，我們已將 3 種擬議的生物類似藥轉入臨床階段開發。這些是 EYLEA、Prolia 和 XGEVA 以及 SIMPONI 的候選生物仿製藥。

From a capital market perspective, 2022 was truly transformational as we moved from being a private company into a public one. We are now listed on NASDAQ both in U.S. and Iceland. We have been able to access the capital markets in order to secure necessary financing to allow us to continue to invest into our programs and the infrastructure.

從資本市場的角度來看，2022 年是真正的轉型，因為我們從一家私營公司轉變為一家上市公司。我們現在在美國和冰島的納斯達克上市。我們已經能夠進入資本市場，以獲得必要的融資，使我們能夠繼續投資於我們的項目和基礎設施。

Finally, we have implemented an ESG framework at the company that includes Board level oversights and transparency through our ESG Portal available on our website.

最後，我們在公司實施了一個 ESG 框架，其中包括通過我們網站上提供的 ESG 門戶進行董事會級別的監督和透明度。

As we look back on 2022, we can confidently say that Alvotech has advanced greatly as a global biosimilar company. I'm very proud of the accomplishments of the team and believe strongly that we have put ourselves in a position to drive growth in 2023 and beyond.

回顧 2022 年，我們可以自信地說 Alvotech 作為一家全球生物仿製藥公司取得了長足的進步。我為團隊取得的成就感到非常自豪，並堅信我們已經能夠在 2023 年及以後推動增長。

And with that, I would like to pass the call over to Anil Okay, our Chief Commercial Officer. Over to you, Anil.

有了這個，我想把電話轉給我們的首席商務官 Anil Okay。交給你了，阿尼爾。

Thanks, Robert. Let me provide a brief overview of AVT02, our biosimilar to HUMIRA.

謝謝，羅伯特。讓我簡要概述 AVT02，我們的 HUMIRA 生物仿製藥。

As you know, we have developed from the beginning a high-concentration citrate-free biosimilar that comes with a proprietary autoinjector. And as Robert mentioned earlier, this product is now launched in 17 markets, including Canada and a number of retail markets in Europe.

如您所知，我們從一開始就開發了一種高濃度、不含檸檬酸鹽的生物仿製藥，它配備了專有的自動注射器。正如羅伯特之前提到的，該產品現已在 17 個市場推出，包括加拿大和歐洲的一些零售市場。

In the U.S., we are working closely with our commercial partner, Teva, to prepare for launch, which is expected is on July 1, 2023, subject to regulatory approval.

在美國，我們正在與我們的商業合作夥伴 Teva 密切合作，為上市做準備，預計將於 2023 年 7 月 1 日上市，但需獲得監管部門的批准。

As a reminder, the U.S. originator sales for HUMIRA was $18.6 billion based on 2022 data, which, of course, didn't include the 8% price increase taken in the beginning of 2023. And we have the opportunity to be the first interchangeable high-concentration biosimilar on the U.S. market for adalimumab.

提醒一下，根據 2022 年的數據，HUMIRA 在美國的原研藥銷售額為 186 億美元，這當然不包括 2023 年初 8% 的價格上漲。我們有機會成為第一個可互換的高價藥物-美國市場上阿達木單抗的濃縮生物類似藥。

As we move to the next slide, I would like to provide more clarity on why we firmly believe that our approach for AVT02 in the U.S. market is the optimum strategy.

當我們轉到下一張幻燈片時，我想更清楚地說明為什麼我們堅信我們在美國市場上針對 AVT02 的方法是最佳策略。

Given the magnitude of this loss of exclusivity, there has been a great deal of discourse around this launch. We consider it to be the first of its kind, featuring a payer-driven biosimilar market formation and a truly retail model. I will outline our strategy using 4 key pillars.

鑑於這種排他性損失的嚴重性，圍繞此次發布進行了大量討論。我們認為這是同類產品中的第一個，以支付者驅動的生物仿製藥市場形成和真正的零售模式為特色。我將使用 4 個關鍵支柱概述我們的戰略。

The first is to develop the right product, and the high concentration currently reflects around 85% of the total volume in the U.S. Currently, there is only 1 approved high-concentration biosimilar, and we are aware of 2 other companies that have announced submissions supporting the high-concentration form.

首先是開發合適的產品，高濃度目前占美國總產量的85%左右。目前，只有1個獲批的高濃度生物類似藥，我們知道還有2家公司已經宣布提交支持高濃度形式。

The second is to combine the right product with interchangeability, which is an important construct for the U.S. market. Interchangeability, we believe, will make it easier to transition patients to the biosimilar. According to a recent report by Cardinal Health, which surveyed HCPs across various therapeutic areas, over 60% of respondents expressed their willingness to prescribe the biosimilar whilst it has obtained the interchangeable designation. And if we are approved, we have the potential to be the first interchangeable high-concentration biosimilar to HUMIRA on the U.S. market for a period of at least 1 year post our launch, based on our interpretation of the exclusivity provisions.

第二是將合適的產品與可互換性相結合，這是美國市場的重要組成部分。我們相信，互換性將使患者更容易過渡到生物仿製藥。根據 Cardinal Health 最近的一份報告，該報告對各個治療領域的 HCP 進行了調查，超過 60% 的受訪者表示他們願意在獲得可互換名稱的同時開出生物仿製藥的處方。如果我們獲得批准，根據我們對排他性條款的解釋，我們有可能成為美國市場上第一個與 HUMIRA 可互換的高濃度生物仿製藥，有效期至少為一年。

The next pillar of our strategy is the autoinjector. As predominantly self-administered products taken relatively frequently, the autoinjector is an important part of the patient experience and physician confidence level. As a result, we chose to invest in a proprietary autoinjector to help support the product rollout. Thus far, we have had very positive reception to our device in the retail markets where we have launched the product outside the U.S.

我們戰略的下一個支柱是自動注射器。由於主要是自我管理的產品使用頻率相對較高，因此自動注射器是患者體驗和醫生信心水平的重要組成部分。因此，我們選擇投資專有的自動注射器來幫助支持產品的推出。到目前為止，我們在零售市場對我們的設備產生了非常積極的反響，我們在美國境外推出了該產品。

And finally, we needed to establish commercial presence and have supply reliability. This is why we have partnered with Teva, a well-known, reputable company in both specialty and generics. Teva has demonstrated its ability to commercialize biosimilars in the U.S., and, just as importantly, Teva has a long-term commitment to biosimilars going forward.

最後，我們需要建立商業存在並具有供應可靠性。這就是我們與 Teva 合作的原因，Teva 是一家在專業藥和仿製藥領域享有盛譽的知名公司。 Teva 已經證明了其在美國將生物仿製藥商業化的能力，而且同樣重要的是，Teva 對未來的生物仿製藥有著長期的承諾。

Further, as a private company, we were able to invest into building out our infrastructure so we could have in-house capacity. This capacity is dedicated to our portfolio and pipeline, and we had the opportunity to host many of the larger payers in the U.S. market at our facility this last summer.

此外，作為一家私營公司，我們能夠投資建設我們的基礎設施，這樣我們就可以擁有內部能力。這種能力專門用於我們的產品組合和管道，去年夏天我們有機會在我們的工廠接待美國市場上的許多大型付款人。

The adalimumab market will be a competitive model, and this is why we believe it's important to have a differentiated strategy that can be successful in this market.

阿達木單抗市場將是一個競爭模式，這就是為什麼我們認為擁有能夠在這個市場上取得成功的差異化戰略很重要。

With that, I would like to turn the call over to Hafrun, our new Chief Operating Officer, to go over our second candidate and overall pipeline of products. Thank you.

有了這個，我想把電話轉給我們的新首席運營官 Hafrun，來檢查我們的第二個候選人和整個產品線。謝謝。

Thank you, Anil. And also thank you, Robert for your kind introduction earlier. I am very excited to be joining Alvotech. Of course, coming from Teva, I did know the company quite well already, and I am a strong believer in Alvotech and in the future, and promises of biosimilars globally.

謝謝你，阿尼爾。還要感謝羅伯特，感謝你之前的熱情介紹。我很高興加入 Alvotech。當然，來自 Teva，我確實已經非常了解這家公司，而且我堅信 Alvotech 和未來，以及全球生物仿製藥的承諾。

It's my pleasure to walk everyone through the rest of our pipeline, starting with our second most advanced biosimilar candidate, which is a proposed biosimilar to STELARA.

我很高興帶領大家完成我們剩餘的管道，從我們的第二個最先進的生物仿製藥候選人開始，這是一種擬議的 STELARA 生物仿製藥。

The originated product approaches $10 billion in global sales based on 2022 figures, and like HUMIRA, it is also in immunology. Alvotech, in my view, was very wise to build out capability using murine cell line, also known as SP2/0. Along with this capability, Alvotech invested into a future manufacturing technology that is required to manufacture these types of biotics. I do believe that this setup has facilitated the AVT04 program, with the marketing application has now been submitted and assessed in major markets, including the U.S. and Europe, with regulatory approval decisions expected in the second half of this year.

根據 2022 年的數據，該原創產品的全球銷售額接近 100 億美元，與 HUMIRA 一樣，它也屬於免疫學領域。在我看來，Alvotech 使用小鼠細胞系（也稱為 SP2/0）來構建能力是非常明智的。除了這種能力，Alvotech 還投資了製造這些類型的生物所需的未來製造技術。我確實相信這種設置促進了 AVT04 計劃，營銷申請現已提交並在包括美國和歐洲在內的主要市場進行了評估，監管部門的批准決定預計將在今年下半年做出。

AVT04, we think, is quite an attractive asset for a couple of reasons. The first is that STELARA is at high price point today relative to some of the other products in the space, allowing biosimilar entrants to potentially drive significant cost reduction for patients and for the health care systems.

我們認為，出於幾個原因，AVT04 是一項極具吸引力的資產。首先是 STELARA 相對於該領域的其他一些產品而言目前處於高價位，這使得生物仿製藥進入者有可能為患者和醫療保健系統顯著降低成本。

The second is that there were a number of companies that were and remain active in biosimilar space that have not participated thus far in the clinical development of STELARA biosimilars. As far as companies that have announced submissions on acceptance for filing in major markets, we believe it is currently limited to Alvotech, although we are aware of another filing on others that have introduced the positive top line results on Phase III.

第二個是，有許多公司在生物仿製藥領域一直很活躍，但迄今為止尚未參與 STELARA 生物仿製藥的臨床開發。至於已宣布接受在主要市場提交備案的公司，我們認為目前僅限於 Alvotech，儘管我們知道其他公司的另一份備案已經在 III 期取得了積極的頂線結果。

We expect to be in the first wave for STELARA biosimilars in U.S. and in Europe, and we are very pleased with our progress to date. We currently anticipate that our inspection, expected later this month from FDA, will also serve as a pre-approval inspection for AVT04.

我們希望成為美國和歐洲 STELARA 生物仿製藥的第一波浪潮，我們對迄今為止取得的進展感到非常滿意。我們目前預計我們的檢查（預計本月晚些時候來自 FDA）也將作為 AVT04 的預批准檢查。

Moving to the next slide, let us shift our focus to the broader pipeline. We continue to receive regulatory approvals for AVT02 in additional markets and work with our supply chain and commercial partners on pricing, reimbursement and launch timing for each market.

轉到下一張幻燈片，讓我們將注意力轉移到更廣泛的管道上。我們繼續在其他市場獲得 AVT02 的監管批准，並與我們的供應鍊和商業合作夥伴就每個市場的定價、報銷和發佈時間進行合作。

For AVT04, as noted, we have 5 in major markets, and we look to continue filings in other jurisdictions around the world. Please note that number of markets require either a U.S. or European certification or approval as pre-filing, or, in some cases, as pre-launch requirement.

對於 AVT04，如前所述，我們在主要市場有 5 個，我們希望繼續在世界其他司法管轄區提交申請。請注意，許多市場需要美國或歐洲的認證或批准作為預備案，或者在某些情況下作為上市前要求。

Over time, and subject regulatory approval, we expect to commercialize our portfolio in over 90 markets around the world.

隨著時間的推移，並獲得監管部門的批准，我們預計將在全球 90 多個市場將我們的產品組合商業化。

Beyond 02 and 04, in the past year, we have successfully initiated clinical development for 3 biosimilar candidates, AVT06, AVT03 and AVT05, which are all currently in active clinical development.

除了02和04，在過去的一年裡，我們已經成功啟動了3個候選生物仿製藥的臨床開發，AVT06、AVT03和AVT05，目前都在積極的臨床開發中。

AVT06 is a proposed biosimilar to EYLEA and is currently in a confirmatory clinical study.

AVT06 是 EYLEA 的擬議生物仿製藥，目前正在進行驗證性臨床研究。

AVT03 is a proposed biosimilar to Prolia and XGEVA and is currently in a patient trial as well as in our bioequivalent study.

AVT03 是 Prolia 和 XGEVA 的擬議生物仿製藥，目前正在進行患者試驗以及我們的生物等效性研究。

AVT05 is a biosimilar candidate to SIMPONI and SIMPONI ARIA. And SIMPONI, like STELARA, is a product developed using SP2/0 cell line and manufacturing using perfusion technology. AVT05 is currently in an active bioequivalent study.

AVT05是 SIMPONI 和 SIMPONI ARIA 的候選生物仿製藥。而SIMPONI與STELARA一樣，都是採用SP2/0細胞系開發，採用灌注技術製造的產品。 AVT05目前正在進行一項活躍的生物等效性研究。

As Robert mentioned earlier, Alvotech is a biosimilar platform. Our pipeline progress is a testament to the platform capabilities. I am excited to keep our stakeholders updated as our pipeline continues to advance and potentially expand in the future.

正如羅伯特之前提到的，Alvotech 是一個生物仿製藥平台。我們的管道進展證明了平台的能力。隨著我們的管道繼續推進並可能在未來擴展，我很高興讓我們的利益相關者了解最新情況。

And with that, I would like to turn the presentation over to Joel Morales, our Chief Financial Officer, to provide a financial update for the company. Thank you.

因此，我想將演示文稿轉交給我們的首席財務官 Joel Morales，為公司提供最新的財務信息。謝謝。

Thanks, Hafrun. I'll now provide some brief financial highlights for the period ending December 31, 2022.

謝謝，哈夫倫。我現在將提供一些截至 2022 年 12 月 31 日期間的簡要財務摘要。

On our third quarter business update in November, we reported that we had executed financing agreements with existing lenders and shareholders to secure $136 million of gross proceeds. As part of the commitments we had made to our lenders, we also reported that we intended to raise up to $150 million of additional capital over the near to midterm, and that we were evaluating a variety of different capital instruments including convertible debt, common equity and preferred equity.

在我們 11 月份的第三季度業務更新中，我們報告說我們已經與現有貸方和股東簽署了融資協議，以確保獲得 1.36 億美元的總收益。作為我們對貸方做出的承諾的一部分，我們還報告說我們打算在中短期內籌集高達 1.5 億美元的額外資本，並且我們正在評估各種不同的資本工具，包括可轉換債券、普通股和優先股。

I'm pleased to report that since then, we have fulfilled this commitment to our lenders and have subsequently finalized a convertible bond issuance of $70 million, of which $56 million was collected in December and the balance of $14 million in Q1 of 2023. $50 million of these proceeds were used to replace the Alvogen shareholder loan facility from our November financing, which allowed us to avoid the issuance of 4% penny warrants attached to the facility.

我很高興地報告，從那時起，我們履行了對貸方的這一承諾，隨後完成了 7000 萬美元的可轉換債券發行，其中 5600 萬美元已於 12 月收回，其餘 1400 萬美元已於 2023 年第一季度收回。50這些收益中有 1000 萬美元用於替換我們 11 月份融資中的 Alvogen 股東貸款融資，這使我們能夠避免發行該融資附帶的 4% 便士認股權證。

Additionally, in early February, we announced that we successfully raised $137 million in gross proceeds in a private placement with Icelandic investors. Altogether, we were able to raise $157 million of gross proceeds incremental to our November financing and net of the replacement of the Alvogen shareholder loan facility of $50 million.

此外，在 2 月初，我們宣佈在與冰島投資者的私募中成功籌集了 1.37 億美元的總收益。總而言之，我們能夠籌集到 1.57 億美元的總收益，增加了我們 11 月份的融資，並扣除了 5000 萬美元的 Alvogen 股東貸款安排。

As a result of this additional capital, we also avoided the issuance of an additional 1% of penny warrants to our first lien lenders under the terms of the November agreement.

由於這筆額外資金，我們還避免了根據 11 月協議的條款向我們的第一留置權貸款人額外發行 1% 的便士認股權證。

We ended the year with approximately $66 million of cash on hand as of December 31. Giving effect to the financing now in place, our pro forma cash balance as of December 31 would have been approximately $209 million, excluding restricted cash of $25 million. We are proud to have raised this significant capital and to have avoided the potentially higher cost in terms of dilution from warrants, which we believe is a significant accomplishment given the backdrop of the challenging capital market conditions.

截至 12 月 31 日，我們在年末手頭現金約為 6600 萬美元。考慮到現有融資，截至 12 月 31 日，我們的備考現金餘額約為 2.09 億美元，不包括 2500 萬美元的受限制現金。我們很自豪能夠籌集到這筆巨額資金，並避免了認股權證攤薄帶來的潛在更高成本，我們認為，在充滿挑戰的資本市場條件下，這是一項重大成就。

We're also pleased to have garnered considerable interest from investors in our company and its prospects. With the funds raised, we plan to continue investing in our platform, our pipeline and our ongoing commercial launches.

我們也很高興能引起投資者對我們公司及其前景的極大興趣。有了籌集的資金，我們計劃繼續投資於我們的平台、管道和正在進行的商業發布。

In terms of our operating performance, the company recorded $85 million in total revenue for 2022, which represented an increase of 114% versus the prior year. This included $25 million of product revenues in our first year of launch from Canada and certain European markets, as well as $60 million in license, milestone and other revenues.

就我們的經營業績而言，公司 2022 年的總收入為 8500 萬美元，比上年增長 114%。這包括我們在加拿大和某些歐洲市場推出的第一年的 2500 萬美元產品收入，以及 6000 萬美元的許可、里程碑和其他收入。

A point worthwhile noting is that we believe that our year-to-date cost of product revenues are disproportionate relative to our revenues in the period. We do expect this to normalize as we increase scale and expand on our launches. We anticipate that this increase in volumes will have a favorable impact on cost of product revenues, particularly when we increase absorption of our fixed costs.

值得注意的一點是，我們認為我們年初至今的產品收入成本與我們當期收入不成比例。我們確實希望隨著我們擴大規模並擴大我們的發布，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，尤其是當我們增加固定成本的吸收時。

Now transitioning to 2023, at this juncture, we are planning to wait to provide our 2023 financial guidance until after the potential U.S. approval and launch of AVT02. Accordingly, we intend to provide more details regarding our operating outlook during our Q2 earnings call.

現在過渡到 2023 年，此時此刻，我們計劃等到美國可能批准並推出 AVT02 之後再提供我們的 2023 年財務指導。因此，我們打算在第二季度的財報電話會議上提供有關我們運營前景的更多詳細信息。

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're anticipating later this year, including in the U.S.

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。

Our pre-launch preparations have resulted in a build of inventory of approximately $32 million through December 31, and we expect that to continue in the first half of the year, leading up to our anticipated launch in the U.S. on July 1.

截至 12 月 31 日，我們的上市前準備工作已形成約 3200 萬美元的庫存，我們預計今年上半年將繼續這種情況，直至我們預計於 7 月 1 日在美國上市。

Also, given the timing of our performance-based licensing and R&D milestones, we expect to recognize most of our milestone and licensing revenue for the year in the second half of 2023.

此外，考慮到我們基於性能的許可和研發里程碑的時間安排，我們預計將在 2023 年下半年確認我們今年的大部分里程碑和許可收入。

And finally, we closed the period with 248.6 million shares outstanding, including the earnout shares which had not yet vested.

最後，我們以 2.486 億股流通股結束了這一時期，包括尚未歸屬的盈利股票。

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 now take the first question. It comes from the line of Thibault Boutherin from Morgan Stanley.

（操作員說明）我們現在將回答第一個問題。它來自摩根士丹利的 Thibault Boutherin 系列。

Thibault calling. First one on STELARA. Just to know if you could -- if you have clarity in terms of the launch timing, in particular with regards to the IP and any potential IP of (inaudible) and if you can share this with us? In particular, any theories in terms of filing and approval time lines? It looks like you could launch STELARA as well approved in the U.S., so just you could comment on that.

蒂博打電話。 STELARA 上的第一個。只是想知道您是否可以 - 如果您清楚發佈時間，特別是關於 IP 和（聽不清）的任何潛在 IP，您是否可以與我們分享？特別是，關於備案和批准時間線的任何理論？看起來你可以推出在美國獲得批准的 STELARA，所以你可以對此發表評論。

And then second question, if you could just give some high-level comments on what you're seeing on the market with the performance of the first biosimilar for HUMIRA and how you see this evolving through the year as obviously, we go through the second wave of biosimilars being approved from July? So yes, some maybe very general comments on the state of the market and the first data you have on the first biosimilar.

然後是第二個問題，如果你能就你在市場上看到的第一個 HUMIRA 生物仿製藥的表現以及你如何看待這一年的發展做出一些高層次的評論，我們將通過第二個生物仿製藥浪潮從 7 月開始獲批？所以是的，一些可能是關於市場狀況的非常籠統的評論，以及你對第一個生物仿製藥的第一個數據。

Thank you so much. Robert Wessman here. So first of all, we filed ustekinumab fourth quarter last year. Generally, we have not said publicly when we believe we would be able to launch. What I can say, though, is that we believe that we are in a very good position on this opportunity, if you will. We have approval decision coming up, we believe, both in U.S. and EU in the second half of this year. And as we have discussed, there seems to be less biosimilar competition when it comes to ustekinumab. So all in all, we are quite excited about the opportunity.

太感謝了。羅伯特韋斯曼在這裡。所以首先，我們在去年第四季度提交了 ustekinumab。一般來說，我們並沒有公開表示我們認為我們能夠推出的時間。不過，我能說的是，如果您願意的話，我們相信我們在這個機會上處於非常有利的位置。我們相信，今年下半年美國和歐盟都會做出批准決定。正如我們所討論的，在優特克單抗方面，生物仿製藥的競爭似乎較少。所以總而言之，我們對這個機會感到非常興奮。

Then I will hand it over to Anil Okay to take the second half.

然後我會把它交給 Anil Okay 來負責下半場。

Thank you, Robert. Thibault, nice to hear from you. Thanks for your question. First of all, regarding Amgen launch, which is, of course, very recent event, so we do not have enough facts about it yet, however, I would like to remind that it was a low concentration formulation launch without interchangeability. I prefer not to comment on what other companies are saying. However, from a vantage point of view, we view our product in the U.S. as a differentiated offering. And also, we believe that particularly because AbbVie will remain on formulary for the near term, that we believe interchangeability is very important differentiation, especially for the companies that will be entering into the market by 1st of July.

謝謝你，羅伯特。 Thibault，很高興收到你的來信。謝謝你的問題。首先，關於 Amgen 的發布，這當然是最近的事件，所以我們還沒有足夠的事實，但是，我想提醒一下，這是一個沒有互換性的低濃度製劑發布。我不想對其他公司的言論發表評論。然而，從有利的角度來看，我們將我們在美國的產品視為差異化產品。而且，我們認為，特別是因為 AbbVie 將在短期內保持處方集，我們認為可互換性是非常重要的差異化，特別是對於將於 7 月 1 日進入市場的公司而言。

We will now take the next question. It comes from the line of Niall Alexander from Deutsche Bank.

我們現在開始下一個問題。它來自德意志銀行的 Niall Alexander 系列。

It's Niall Alexander from Deutsche Bank. Just 2 questions. It would be good to get your views on what the country-by-country rollout will look like in 2023 for AVT02, and where do you see the biosimilar share overall reaching in the EU?

我是德意志銀行的 Niall Alexander。只有2個問題。最好就 AVT02 在 2023 年的國家/地區推出情況發表看法，以及您認為生物仿製藥在歐盟的總體份額在哪裡？

And then the second question, if you can just give any color and thoughts as to potential hurdles or sort of questions that FDA are pushing on the ongoing inspection of facilities to get the AVT02 U.S. approval finalized?

然後是第二個問題，您是否可以就 FDA 推動對設施進行持續檢查以最終確定 AVT02 美國批准的潛在障礙或問題給出任何顏色和想法？

Niall, thanks for your question. Let me take the first one, and I will hand over the second question to my colleagues. So regarding our rollout, just to remind that our European launch has happened in June 2022. And since then, we have a track record of doubling our sales, so we have really good projections in Europe. And our commercial partner, STADA, is doing a very good job in the key retail markets. So we are very satisfied with the progress and the performance.

尼爾，謝謝你的問題。第一個我先說，第二個問題交給同事。因此，關於我們的推出，只是提醒我們，我們的歐洲推出發生在 2022 年 6 月。從那時起，我們的銷售額翻了一番，因此我們對歐洲的預測非常好。我們的商業合作夥伴 STADA 在主要零售市場做得很好。所以我們對進展和表現非常滿意。

Additionally, as Hafrun mentioned, in 2023, on top of U.S., we have lined up several other regulatory approvals, and we will be rolling out AVT02 into many more markets in 2023, which will, of course, help us to have additional sales revenues in 2023. Thank you.

此外，正如 Hafrun 提到的，2023 年，除了美國，我們還獲得了其他幾項監管批准，我們將在 2023 年將 AVT02 推廣到更多市場，這當然會幫助我們獲得額外的銷售收入2023 年。謝謝。

Yes. And Robert Wessman here, I will take the second half part of the question. So I would say, first of all, there has been a significant communication with FDA post the 483s which we received end of March 2022.

是的。羅伯特韋斯曼，我將回答問題的後半部分。所以我想說，首先，我們在 2022 年 3 月底收到的 483 之後與 FDA 進行了重要溝通。

It has been an interactive process, if you will, where we have submitted responses to FDA. That includes number of productive and preventative actions, if you will, based on quality piece and we have, of course, received feedback from FDA. At this stage, we feel as we have addressed the issues that have been raised in the 483s. However, from our preparation, we looked at this as a reinspection as general GMP inspection, and we have been preparing accordingly.

這是一個互動的過程，如果你願意的話，我們已經向 FDA 提交了回复。這包括一些生產性和預防性措施，如果你願意的話，基於質量，我們當然已經收到了來自 FDA 的反饋。在這個階段，我們覺得我們已經解決了 483 中提出的問題。但是，從我們的準備來看，我們把這次復查看成是一般的GMP檢查，我們一直在做相應的準備。

So overall, we are very optimistic, and we believe that the company is well prepared for the upcoming visit which starts on Monday.

所以總的來說，我們非常樂觀，我們相信公司已經為周一開始的即將到來的訪問做好了充分的準備。

We will now take the next question. It comes from the line of Andrew Baum from Citi.

我們現在開始下一個問題。它來自 Citi 的 Andrew Baum 系列。

A couple of questions. First, since we last heard from you, AbbVie has given a point estimate for anticipated declines for U.S. HUMIRA in 2023 of 37%. I'm curious whether that number was above or below your expectations for the overall market, and how that fits with your own internal modeling?

幾個問題。首先，自從我們上次收到您的來信以來，AbbVie 給出了 2023 年美國 HUMIRA 預期下降 37% 的點估計。我很好奇這個數字是高於還是低於您對整個市場的預期，以及它如何符合您自己的內部模型？

And then second, could you talk to your expectation of AbbVie's contracting to multiyear contracts, and therefore, we should think about concessions which are going to secure positioning on formularies for 2024 as well as 2023?

其次，您能否談談您對 AbbVie 簽訂多年合同的期望，因此，我們應該考慮讓步，以確保在 2024 年和 2023 年的處方集上的定位？

Thank you, Andrew, for your question. Of course, we are not leading those contracting discussions but support our partner, Teva, where we can. The discussions we understand are very collaborative and supportive, and reinforces the product profile attributes very well. We are approved on April 13, as we communicated. We believe we will have broad formulary access and that our product profile will be differentiated from other biosimilars on the market.

謝謝你，安德魯，你的問題。當然，我們不會領導那些合同討論，而是盡可能支持我們的合作夥伴 Teva。我們理解的討論是非常協作和支持的，並且很好地強化了產品配置文件屬性。正如我們溝通的那樣，我們於 4 月 13 日獲得批准。我們相信我們將擁有廣泛的處方訪問權，並且我們的產品概況將與市場上的其他生物仿製藥有所不同。

As I also highlighted in the previous question, we believe, particularly because AbbVie will remain on formulary for the near term as they have communicated to the market, that interchangeability is critically important, and I really would like to remind again that Alvotech is the only candidate that can still have an interchangeable high-concentration biosimilar for adalimumab in the U.S. market by 1st of July 2023.

正如我在上一個問題中也強調的那樣，我們相信，特別是因為 AbbVie 在與市場溝通時將在短期內保持處方集，互換性至關重要，我真的想再次提醒 Alvotech 是唯一的到 2023 年 7 月 1 日，仍可在美國市場上擁有可互換的阿達木單抗高濃度生物仿製藥的候選藥物。

(Operator Instructions) There are no further questions at this time. I would like to hand back over to Benedikt Stefansson for final remarks.

（操作員說明）目前沒有其他問題。我想把最後的評論交還給 Benedikt Stefansson。

Thank you, Sandra. So on behalf of the Alvotech team, I would like to thank all the participants on our webcast today, and we wish you a good rest of the day and look forward to speaking with you all again. Thank you.

謝謝你，桑德拉。因此，我謹代表 Alvotech 團隊，感謝今天網絡直播的所有參與者，祝您今天休息愉快，並期待與大家再次交談。謝謝。

That does conclude our conference for today. Thank you for participating. You may all disconnect.

我們今天的會議到此結束。感謝您的參與。你們都可以斷開連接。