Alvotech SA (ALVO) 2023 Q2 法說會逐字稿

Welcome to the second quarter 2023 earnings call for Alvotech. (Operator Instructions) I would now like to introduce and hand the conference over to Mr. Benedikt Stefansson, Senior Director of Investor Relations and Global Communications of Alvotech. Please proceed.

歡迎參加 Alvotech 2023 年第二季財報電話會議。 （操作員須知）我現在介紹一下會議，並將會議交給Alvotech投資者關係和全球傳播高級總監Benedikt Stefansson先生。請繼續。

Thank you, and good morning to our U.S. audience and good afternoon to our listeners in Iceland, Europe and Asia. 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 second quarter results.

謝謝大家，美國聽眾早安，冰島、歐洲和亞洲的聽眾都下午好。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第二季業績相關的主要亮點。

Additionally, presentation slides that cover our call today have been posted on our website in the Events section of investors.alvotech.com. We will be referring to these slides during our presentation today. Our presentation materials and some of the 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 are inherently subject to risks, variability and contingencies many of which are beyond Alvotech's control and could cause actual results to differ materially from forward-looking statements that are made.

此外，涵蓋我們今天電話會議的簡報幻燈片已發佈在我們網站 Investors.alvotech.com 的「活動」部分。我們將在今天的簡報中參考這些幻燈片。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本質上受到風險、可變性和意外事件的影響，其中許多風險和意外事件超出了 Alvotech 的控制範圍，並可能導致實際結果與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, Chief Strategy Officer. With that, I would like to turn the call over to Robert Wessman, Founder, Chairman and CEO of Alvotech. Robert?

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 (Joel Morales) 擔任首席財務官，李明 (Ming Li) 擔任首席戰略官。現在，我想將電話轉給 Alvotech 的創辦人、董事長兼執行長 Robert Wessman。羅伯特？

Thank you, Benedikt, and thank you all for joining us here today. Allow me to kick off today's discussion by sharing some pivotal update since our last public communication. To begin with, we have resubmitted interchangeable BLA for our proposed biosimilar to HUMIRA, also known as a AVT02.

謝謝貝內特，也謝謝大家今天加入我們。請允許我透過分享自上次公開溝通以來的一些關鍵更新來開始今天的討論。首先，我們已經為我們提議的 HUMIRA 生物相似藥（也稱為 AVT02）重新提交了可互換的 BLA。

As a reminder, we have developed a high concentration formulation of adalimumab, which is the predominant form on the market today, and we have met all requirements to secure interchangeability if FDA deems our application approval for both biosimilarity and the interchangeability subject to a positive reinspection of our facility in Reykjavik, Iceland. We aim to complete a satisfactory inspection during the review period for the submitted application and expect AVT02 to be a material contributor in 2024. If given final approval. Over the course of past 18 months, Alvotech has undergone significant changes as we transition from a development stage company to a full-scale commercial operation. We have made and continue to make significant investments in our manufacturing and quality processes and have taken the feedback received from FDA inspections to focus these investments. We are confident that the changes that we have made at our site to put the company in the best positions for our satisfactory reinspection.

提醒一下，我們已經開發了阿達木單抗的高濃度製劑，這是當今市場上的主要形式，如果FDA 認為我們的生物相似性和可互換性申請批准需要經過積極的重新檢查，我們就滿足了確保可互換性的所有要求我們在冰島雷克雅未克的工廠。我們的目標是在提交的申請的審查期間完成令人滿意的檢查，並期望 AVT02 在 2024 年成為材料貢獻者。在過去 18 個月的時間裡，Alvotech 經歷了重大變化，從一家開發階段的公司過渡到全面的商業營運。我們已經並將繼續對我們的製造和品質流程進行重大投資，並根據 FDA 檢查收到的回饋來集中這些投資。我們相信，我們在現場所做的改變將使公司處於最佳位置，以進行令人滿意的重新檢查。

Our team has been supported by qualified expert consultants on site. And we have also been working closely with our partner in the U.S., Teva Pharmaceuticals, to ensure that we are putting the company in the best position to succeed. And while the coming inspection is of critical importance to us, it's equally crucial that we have and maintain a continuous improvement mindset when it comes to quality and compliance. We will be able to demonstrate that culture during the next inspection as well as for future inspections.

我們的團隊得到了合格的現場專家顧問的支持。我們也一直與我們在美國的合作夥伴 Teva Pharmaceuticals 密切合作，以確保我們使公司處於成功的最佳位置。雖然即將到來的檢查對我們至關重要，但在品質和合規性方面，我們擁有並保持持續改進的心態也同樣重要。我們將能夠在下一次檢查以及未來的檢查中展示這種文化。

Next, I would like to highlight the recent business development progress we have made at the company. In late May of this year, we signed a new partnership with Advanz, which includes 5 biosimilar candidates.

接下來我想重點介紹一下公司近期業務發展的進展。今年 5 月下旬，我們與 Advanz 簽署了新的合作夥伴關係，其中包括 5 種生物相似藥候選藥物。

The transaction includes two previously identified proposed biosimilars as well as three new early-stage candidates that were previously undisclosed. More recently in late July, we expanded our collaboration with Teva, our U.S. commercial partner, to include two new biosimilar candidates as well as line extension for two proposed biosimilars that were part of our initial agreement.

該交易包括兩種先前確定的擬議生物相似藥以及三種先前未披露的新的早期候選藥物。最近在 7 月下旬，我們擴大了與我們的美國商業合作夥伴 Teva 的合作，包括兩種新的生物相似藥候選藥物以及兩種擬議生物相似藥的產品線延伸，這是我們最初協議的一部分。

Both transactions that executed after substantial due diligence on Alvotech's business and demonstrate the confidence that others have in the future potential of Alvotech. We continue to maintain an active pipeline of business development opportunities. As we continue to complete the licensing of our existing pipeline, about further opportunities to our portfolio.

這兩筆交易都是在對 Alvotech 業務進行大量盡職調查後執行的，顯示了其他人對 Alvotech 未來潛力的信心。我們繼續保持活躍的業務發展機會。隨著我們繼續完成現有管道的許可，我們的投資組合將面臨更多機會。

Additionally, I'm pleased to report that June of this year, we announced a settlement agreement between Alvotech and Johnson & Johnson with regards to AVT04, our proposed biosimilar to STELARA a leading immunology treatment globally. This agreement grants Alvotech a license entry date in the U.S. no later on February 21, 2025. Having this settlement now in place provides IP certainty for our second potential offering in the U.S. market. AVT04 is also filed the multiple markets outside the U.S., including Canada, Japan and Europe, and we continue to seek earliest possible entry date in each country where we expect approval.

此外，我很高興地報告，今年 6 月，我們宣布 Alvotech 與強生公司就 AVT04 達成和解協議，AVT04 是我們提議的全球領先免疫療法藥物 STELARA 的生物仿製藥。該協議授予 Alvotech 在美國的許可進入日期不晚於 2025 年 2 月 21 日。 AVT04 也在美國以外的多個市場進行了備案，包括加拿大、日本和歐洲，我們將繼續尋求在我們期望獲得批准的每個國家的盡早上市日期。

Finally, we recently announced an additional capital raise into Alvotech, which allows us the ability to continue to invest in our broad pipeline of biosimilar candidates. Teva, our U.S. commercial partner, Aztiq, the leading shareholder in Alvotech, along with a number of other new and existing investors subscribe to $140 million of convertible bonds on the same terms as our last issuance in the fourth quarter of 2022.

最後，我們最近宣布向 Alvotech 進行額外融資，這使我們能夠繼續投資於我們廣泛的生物相似藥候選產品。我們的美國商業夥伴 Teva、Alvotech 的主要股東 Aztiq 以及其他一些新舊投資者認購了 1.4 億美元的可轉換債券，其條款與我們 2022 年第四季上次發行的條款相同。

This transaction underscores the company capability to access the capital markets and also highlights the backing from both long-standing and new stakeholders that the company enjoys. As you may recall, last December, trading in Alvotech stock in Iceland moved from the first North growth market to NASDAQ, Iceland's main market.

此次交易凸顯了公司進入資本市場的能力，也凸顯了公司所享有的長期和新利害關係人的支持。您可能還記得，去年 12 月，冰島 Alvotech 股票的交易從第一北方成長市場轉移到冰島主要市場納斯達克。

We noted at the time, but this might lead to inclusion in both domestic and international stock market indexes. In February this year, MSCI announced the addition of Alvotech stock to the MSCI Frontier Market Index.

我們當時注意到，但這可能會導致被納入國內和國際股市指數。今年 2 月，MSCI 宣布將 Alvotech 股票納入 MSCI 前沿市場指數。

In June, Alvotech's stock was added to the domestic index here in Iceland, which includes the top 10 share run by trading volume on the NASDAQ Iceland main markets. On August 18, FTSE Russell amounts that Alvotech stock is being considered for potential inclusion in several of the FTSE Global Equity Emerging Europe Indexes including the all-world large cap and total cap indexes.

6 月，Alvotech 的股票被納入冰島國內指數，其中包括納斯達克冰島主要市場交易量排名前 10 名的股票。 8 月 18 日，富時羅素 (FTSE Russell) 表示，Alvotech 股票正在考慮納入多個富時全球股票新興歐洲指數，包括全球大盤股指數和總盤股指數。

The proposed inclusion might be subject to revision and the close of business day tomorrow and the final change will be known by Monday September 4. The FTSE Index changes will then become effective on Monday, September 18.

擬議的納入可能會進行修訂，明天營業日結束時，最終更改將於 9 月 4 日星期一公佈。

Finally, we look forward to providing further updates as we progress through the year. And with this, I would like to turn the call over to Anil Okay, our Chief Commercial Officer, to provide further updates on the business. So over to you, Anil.

最後，我們期待隨著這一年的進展提供進一步的更新。在此，我想將電話轉給我們的商務長阿尼爾·奧凱，以提供有關業務的進一步更新。那就交給你了，阿尼爾。

Thank you, Robert. I would like to start with a business development update. Firstly, since our last public call in May, we have expanded our partnership with Advanz Pharma. The enhanced partnership adds 5 additional proposed biosimilars that are targeted for European markets. These include the biosimilar candidates to SIMPONI and Entyvio as well as 3 early-stage undisclosed biosimilars. This brings our total pipeline products to 11. The transaction brought an upfront payment of approximately USD 61 million as well as additional potential milestone-based payments of over USD 287 million. The in-market revenue share is similar to previous deals that we have executed across other markets as 40% of in-market sales to Alvotech. The transaction was executed after significant due diligence by our partner, which demonstrates the strength of our programs and the company's overall capabilities as a biosimilar developer and manufacturer. Furthermore, it highlights the ability to leverage our platform and monetize assets even in the early stages of development, which we view as a key strength in a business-to-business model.

謝謝你，羅伯特。我想從業務發展的最新情況開始。首先，自 5 月上次公開電話會議以來，我們擴大了與 Advanz Pharma 的合作夥伴關係。此次增強的合作關係增加了 5 種針對歐洲市場的生物相似藥。其中包括 SIMPONI 和 Entyvio 的候選生物相似藥以及 3 種早期未公開的生物相似藥。這使得我們的管道產品總數達到 11 筆。市場內收入份額與我們先前在其他市場執行的交易類似，佔 Alvotech 市場內銷售額的 40%。該交易是在我們的合作夥伴進行了大量盡職調查後執行的，這證明了我們項目的實力以及公司作為生物仿製藥開發商和製造商的整體能力。此外，它還強調了即使在開發的早期階段也能夠利用我們的平台和將資產貨幣化的能力，我們認為這是企業對企業模式的關鍵優勢。

Finally, our business development pipeline remains active. While we have successfully licensed many of our products and territories, we are also in the process of seeking a commercial partner for AVT03 a proposed biosimilar to PROLIA and XGEVA, together with AVT03 a biosimilar candidate to KEYTRUDA. Both proposed biosimilars are in the oncology space, where we intend to expand in the future. We hope to provide updates as our business development progress continues.

最後，我們的業務發展管道仍然活躍。雖然我們已經成功獲得了許多產品和領域的許可，但我們也正在為 AVT03（一種 PROLIA 和 XGEVA 的生物相似藥）以及 AVT03（一種 KEYTRUDA 的候選生物相似藥）尋找商業合作夥伴。這兩種建議的生物相似藥都屬於腫瘤學領域，我們打算在未來擴展該領域。我們希望隨著我們業務發展的不斷進展，提供最新資訊。

Turning to the next slide. We have also provided a summary of the recent expansion in our partnership with Teva for the U.S. market. Teva continues to be steadfastly committed to both the biosimilar market and its partnership with Alvotech. The recent licensing deal and investment in Alvotech serve to affirm Teva's commitment on both fronts. The expanded partnership includes two new biosimilar candidates, which are both exclusive arrangements for the U.S. market. Alvotech may receive up to approximately USD 160 million in additional potential milestone payments from Teva, the majority of which will be due at the time of approval and [open] achieving significant sales targets in addition to the customer revenue share of approximately 40%. The agreement also includes two additional line extensions to previously partnered biosimilars also exclusive for the U.S. market.

轉到下一張投影片。我們也總結了我們最近與 Teva 在美國市場的合作夥伴關係的擴展。 Teva 繼續堅定地致力於生物相似藥市場及其與 Alvotech 的合作。最近的授權協議和對 Alvotech 的投資證實了 Teva 在這兩方面的承諾。擴大的合作關係包括兩種新的生物相似藥候選藥物，它們都是針對美國市場的獨家安排。 Alvotech 可能會從 Teva 收到高達約 1.6 億美元的額外潛在里程碑付款，其中大部分將在批准時支付，並[開放]除了約 40% 的客戶收入份額之外，還實現重大銷售目標。該協議還包括先前合作的生物相似藥的兩個額外產品線的擴展，這些產品同樣專供美國市場。

Additionally, there has and will be increased involvement from Teva to supporting FDA readiness activities at our site in Iceland. We welcome this type of participation and it only strengthens the company's result and confidence in meeting the criteria to support the approval of AVT02 in the U.S. market. Keep in mind the only outstanding item prior to approval of AVT02 is a satisfactory reinspection of the facility.

此外，Teva 已經並將越來越多地參與支持我們冰島工廠的 FDA 準備活動。我們歡迎這種類型的參與，這只會增強公司的績效和信心，以達到支持 AVT02 在美國市場獲得批准的標準。請記住，在批准 AVT02 之前唯一未完成的事項是對設施進行令人滿意的重新檢查。

Last but not least, outside of the licensing agreements, Teva subscribed to a USD 40 million investment into Alvotech in the form of subordinated convertible bonds. The expanded commercial partnership, collaboration around the inspection revenues and the direct investment made by Teva after significant due diligence demonstrates some of the strengths of having a B2B business model where there are numerous stakeholders that have a vested interest in our success.

最後但並非最不重要的一點是，除了許可協議之外，Teva 以次級可轉換債券的形式認購了對 Alvotech 的 4000 萬美元投資。經過大量盡職調查後，梯瓦擴大的商業合作夥伴關係、圍繞檢查收入的合作以及直接投資證明了B2B 商業模式的一些優勢，在這種模式中，有眾多利益相關者對我們的成功擁有既得利益。

Moving on, I would like to provide some more specific product updates. Starting, of course, with AVT02 in the U.S. As Robert noted, we have submitted our interchangeable BLA for our biosimilar to HUMIRA. We expect to receive a new BsUFA date and we'll update the market once that has taken place. This is an important step as it is a communication to the agency, signing that we are prepared to host a reinspection which is required to support approval of AVT02. We anticipate the potential of HUMIRA launch in the U.S. to be a material event for the company in 2024. And we believe that a product profile that could include interchangeability with a high concentration form of adalimumab, combined with the dedicated biosimilar manufacturing facility and experienced commercial partner are factors that could not only allow us to access formularies but also allows us to convert the market more efficiently.

接下來，我想提供一些更具體的產品更新。當然，從美國的 AVT02 開始。我們預計會收到新的 BsUFA 日期，一旦確定，我們將向市場更新。這是重要的一步，因為這是與該機構的溝通，表明我們準備好舉辦重新檢查，以支持 AVT02 的批准。我們預計HUMIRA 於2024 年在美國上市將成為該公司的重大事件。商業團隊夥伴這些因素不僅可以讓我們獲得處方集，還可以讓我們更有效地轉換市場。

We are also together with our partners exploring various go-to-market strategies and remain flexible in our approach. The recent news from CVS demonstrate that the story of retail biosimilars in the U.S., and for HUMIRA for that matter, is still being written. There is a long-term need for biosimilars in the U.S., and we believe that adalimumab is a long-term opportunity for the company.

我們也與合作夥伴一起探索各種進入市場的策略，並保持靈活的方法。 CVS 最近的消息表明，美國零售生物相似藥的故事以及 HUMIRA 的故事仍在書寫中。美國對生物相似藥有長期需求，我們相信阿達木單抗對公司來說是一個長期機會。

With regards to the competition, there are currently only 3 approved high concentration adalimumab biosimilars that are on the U.S. market today. None of these have an interchangeability designation to the high concentration form of HUMIRA. There are 3 companies that have registered trials using the high-concentration form and has stated publicly that they are seeking high concentration interchangeability for the U.S. market. We maintain our view that this differentiation is a significant market advantage and hope that we may gain approval in advance of others as we prepare for the long-term adalimumab market in the U.S.

就競爭而言，目前美國市場上只有 3 種核准的高濃度阿達木單抗生物相似藥。這些藥物與高濃度 HUMIRA 的名稱均不具互換性。有3家公司已註冊使用高濃度形式的試驗，並公開表示正在尋求針對美國市場的高濃度互換性。我們仍然認為這種差異化是一個顯著的市場優勢，並希望在為美國阿達木單抗長期市場做準備時，能夠先於其他公司獲得批准。

Finally, we are commercially launched in 19 markets as of today, which includes 2 additional markets since our last quarter update, and we intend to launch in 2 additional markets before year-end.

最後，截至今天，我們已在 19 個市場進行商業推出，其中包括自上季更新以來的另外 2 個市場，我們打算在年底前在另外 2 個市場推出。

Next, I would like to cover off on AVT04, our proposed biosimilar to STELARA, another leading global immunology treatment. We are currently on file in 7 markets with our approval pending in major markets such as the U.S., EU, Japan and Canada.

接下來，我想介紹一下 AVT04，這是我們提議的另一種全球領先的免疫療法藥物 STELARA 的生物相似藥。目前，我們已在 7 個市場備案，美國、歐盟、日本和加拿大等主要市場正在等待批准。

We intend to file globally and, in some cases, need to wait on approvals or launches before we make submissions in some of the smaller markets. We view the biosimilar opportunity to be substantial. The global market size for the product based on the last 4 quarters ending June 30, 2023, exceeds USD 10 billion.

我們打算在全球範圍內提交申請，在某些情況下，需要等待批准或發布，然後才能在一些較小的市場提交申請。我們認為生物相似藥的機會很大。截至 2023 年 6 月 30 日的過去 4 個季度，該產品的全球市場規模超過 100 億美元。

Additionally, in June of this year, we announced that we reached a settlement agreement with Johnson & Johnson that gives us the ability, subject to regulatory approval to launch AVT04 in the U.S. market, no later than February 21, 2025. In markets outside the U.S., we continue to seek the earliest possible entry dates and we are actively working with our partners in each market on the best go-to-market strategies.

此外，今年 6 月，我們宣布與強生公司達成和解協議，使我們能夠在獲得監管部門批准的情況下，最遲於 2025 年 2 月 21 日在美國市場推出 AVT04。進入日期，我們正在與每個市場的合作夥伴積極合作，以製定最佳的上市策略。

Please note that as a B2B company, we realize revenues in advance of commercial launch. As we supply our partners in any given market. To wrap up on 04, we note that based on public information, there are only 3 companies besides Alvotech that have filed their biosimilar versions for STELARA. We maintain the view that the significant absence of many firms that were involved in the development and commercialization of prior biosimilars, as seen in the HUMIRA case, creates a favorable market environment for those that can successfully develop a STELARA biosimilar and have coupled it with a robust commercial strategy.

請注意，作為一家 B2B 公司，我們在商業發布之前就實現了收入。正如我們為任何特定市場的合作夥伴提供服務一樣。總結 04，我們注意到，根據公開消息，除了 Alvotech 之外，只有 3 家公司提交了 STELARA 的生物仿製藥版本。我們仍然認為，如 HUMIRA 案例所示，許多公司嚴重缺乏參與先前生物相似藥的開發和商業化，這為那些能夠成功開發 STELARA 生物仿製藥並將其與穩健的商業策略。

In closing, before we move to the financials, I would like to briefly touch on the rest of the portfolio. Currently, we have a pipeline and portfolio of 11 biosimilars. And in our last call, we unveiled the specific reference products for AVT16 and AVT23, bringing our disclosed number to 8.

最後，在我們討論財務狀況之前，我想先簡單談談投資組合的其餘部分。目前，我們擁有 11 種生物相似藥的研發管線和產品組合。在上次電話會議中，我們公佈了 AVT16 和 AVT23 的具體參考產品，使我們揭露的數量達到 8 個。

We currently are advancing 3 pipeline candidates in patient studies. These are AVT03 biosimilar candidate to PROLIA and XGEVA; AVT06, proposed biosimilar to EYLEA and AVT05, a proposed biosimilar to SIMPONI and SIMPONI ARIA.

我們目前正在患者研究中推進 3 種候選藥物。這些是 PROLIA 和 XGEVA 的 AVT03 候選生物相似藥； AVT06，擬議的 EYLEA 生物相似藥；AVT05，擬議的 SIMPONI 和 SIMPONI ARIA 生物相似藥。

With regards to AVT05, we note that only one other company has a public active development program in clinical studies for the target biologic.

關於 AVT05，我們注意到只有一家公司在目標生物製劑的臨床研究中擁有公開的積極開發計劃。

As a reminder, AVT02, AVT04 and AVT05 are all leading immunology treatments. We believe Alvotech is one of very few companies who are able to offer all these 3 immunology treatments at the same time. We view of the inclusion of all 3 of these immunology treatments in our portfolio as a strategic advantage.

提醒一下，AVT02、AVT04 和 AVT05 都是領先的免疫學治療方法。我們相信 Alvotech 是極少數能夠同時提供所有這 3 種免疫療法的公司之一。我們認為將所有這 3 種免疫學治療納入我們的產品組合中是一項策略優勢。

With respect to AVT16. We are able to scale our pace. We have seen limited announcements so far on advanced programs from other companies and we view this as a very exciting long-term opportunity for Alvotech. Overall, we believe that the global multi-product approach that utilizes our platform is the best strategy to be successful in the long term for biosimilars.

關於 AVT16。我們能夠擴大我們的步伐。到目前為止，我們看到其他公司關於高階專案的公告有限，我們認為這對 Alvotech 來說是一個非常令人興奮的長期機會。總的來說，我們相信利用我們平台的全球多產品方法是生物相似藥長期成功的最佳策略。

As we continue to transition from an R&D-only company to a commercial one, we are committed to not losing the sight of pipeline and portfolio focus. We do expect to add further products in our portfolio in the future and we have a number of early development candidates that are being screened at any given time. With that, I would like to turn the presentation over to Joel Morales, our Chief Financial Officer. Thank you.

隨著我們繼續從純研發公司轉型，我們致力於不忽視管道和投資組合的重點。我們確實希望將來在我們的產品組合中添加更多產品，並且我們有許多早期開發候選產品正在隨時進行篩選。接下來，我想將演講交給我們的財務長喬爾·莫拉萊斯 (Joel Morales)。謝謝。

Thanks, Anil. I'll now provide some brief financial highlights for the period ending June 30, 2023. On our last earnings call in May, we reported that we were exploring financing options to raise additional capital as a result of the uncertainty stemming from the timing of the FDA approval for our BLAs for AVT02. Since then, and as Robert mentioned earlier, we have recently completed a private placement of subordinated convertible bonds for $140 million with a strong participation from a diverse group of Icelandic institutional investors as well as Teva and Aztiq, which subscribed to $40 million and $30 million investments, respectively.

謝謝，阿尼爾。現在，我將提供截至2023 年6 月30 日期間的一些簡要財務要點。額外資本的融資方案。此後，正如羅伯特之前提到的，我們最近完成了1.4 億美元次級可轉換債券的私募，冰島機構投資者以及Teva 和Aztiq 等多元化機構的大力參與，分別認購了4000 萬美元和3000 萬美元。

In addition, during the quarter, we collected over $60 million in cash, primarily from the signing of the licensing deal with Advanz. We ended the first half with $60.5 million of cash on hand. Giving effect to the private placement we recently finalized our pro forma cash balance as of June 30 is approximately $180 million excluding $25 million of restricted cash.

此外，本季我們還收到了超過 6,000 萬美元的現金，主要來自與 Advanz 簽署的授權協議。上半年結束時，我們手上有 6,050 萬美元現金。為了實現私募，我們最近最終確定截至 6 月 30 日的預計現金餘額約為 1.8 億美元，不包括 2500 萬美元的限制性現金。

In terms of our operating performance, the company recorded $22.7 million in product revenue for the first 6 months of 2023 versus $3.9 million during 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.

就我們的經營業績而言，該公司 2023 年前 6 個月的產品收入為 2,270 萬美元，而去年同期為 390 萬美元。這一急劇增長是由 2022 年第二季度開始的發佈時間推動的。

Since then, our partners have continued to expand on share in existing markets, primarily in Europe and Canada, and we have also launched into additional markets throughout the rest of the world. Milestone revenues are negative for the period due to the net impact of licensing arrangements closed during the second quarter. We are in active pursuit of additional licensing opportunities for our pipeline assets as indicated by our most recent deal with Teva and continue to advance the programs in our pipeline, which we anticipate triggering additional revenue recognition and cash collections in the future.

從那時起，我們的合作夥伴繼續擴大在現有市場（主要是歐洲和加拿大）的份額，我們也進入了世界其他地區的其他市場。由於第二季結束的許可安排的淨影響，該期間的里程碑收入為負。正如我們最近與 Teva 的交易所示，我們正在積極為我們的管道資產尋求更多許可機會，並繼續推進我們管道中的項目，我們預計這將在未來引發額外的收入確認和現金回收。

As I've mentioned on previous calls, we expect to recognize most of our milestone and licensing revenue for this year in the second half of 2023. Keep in mind that the timing of when we recognize revenue differs from cash collections as a portion of cash collection is attributed to R&D development milestones and are recognized over time. Another point worthwhile noting is that cost of product revenue for the first half 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.

正如我在之前的電話會議中提到的，我們預計將在 2023 年下半年確認今年的大部分里程碑和許可收入。因於研發發展里程碑，並隨著時間的推移而獲得認可。另一點值得注意的是，由於新品上市的時機和生產相關費用的增加，上半年產品收入成本與產品收入不成比例，導致成本高於當期確認的收入。我們確實預計，隨著我們擴大製造規模並擴大產品發布，這種情況將會正常化。我們預計，銷售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。

In terms of liquidity, based on our current operating plans and the latest round of financing, we believe we have adequate cash runway to continue investing behind our operations and the pipeline.

在流動性方面，根據我們目前的營運計劃和最新一輪融資，我們相信我們有足夠的現金跑道來繼續投資我們的業務和管道。

As noted earlier, we are waiting for an FDA response to our recently resubmitted AVT02 BLA which will determine the timelines going forward. Marketing applications for AVT04 are also currently under review in major markets, including by the EMA, Health Canada and Japan which could reach regulatory conclusion in the second half of this year, potentially allowing us to realize revenue for AVT04 in certain markets before the end of the year.

如前所述，我們正在等待 FDA 對我們最近重新提交的 AVT02 BLA 的回應，這將確定未來的時間表。 AVT04 的行銷申請目前也在主要市場進行審查，包括 EMA、加拿大衛生部和日本，可能會在今年下半年得出監管結論，這可能使我們能夠在年底前在某些市場實現 AVT04 的收入那一年。

Additionally, approvals in various markets may lead to milestone payments and revenue recognition with certain partners. The exact timing and results of these events is, however, currently subject to uncertainty. Also, 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. The potential closing of BD transactions fall within 2023, however, are subject to timing uncertainty as well.

此外，各個市場的批准可能會導致某些合作夥伴的里程碑付款和收入確認。然而，這些事件的確切時間和結果目前尚不確定。此外，正如 Anil 先前在演講中指出的，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。然而，BD 交易可能會在 2023 年完成，但也存在時間不確定性。

Uncertainty about the timing and outcome of each of these positive events leads us to the conclusion that providing guidance based on the information available at this time would not be particularly constructive. As our business matures with more regulatory certainty in the U.S. and there becomes a more stable base of business with less uncertainty, it will become easier to incorporate ranges of outcome on our numerous opportunities and become more specific and accurate with guidance. We will continue to determine the right stage to provide guidance going forward. On a final note, we closed the period with 266 million shares outstanding, including unvested earn-out shares. And with that, I'd like to turn the call back over to the operator for Q&A.

這些積極事件的時間和結果的不確定性使我們得出這樣的結論：根據目前可用的資訊提供指導不會特別有建設性。隨著我們的業務在美國的監管確定性不斷提高，業務基礎更加穩定，不確定性越來越小，我們將更容易將一系列結果納入我們眾多的機會中，並在指導下變得更加具體和準確。我們將繼續確定合適的階段以提供未來指導。最後一點，我們在本季末發行了 2.66 億股流通股，其中包括未歸屬的獲利股。這樣，我想將電話轉回給接線生進行問答。

(Operator Instructions) And the questions come from the line of Carl Byrnes from Northland Capital Markets.

（操作員說明）問題來自 Northland Capital Markets 的 Carl Byrnes。

Congratulations on your progress. First off, can you reconcile the second quarter '23 net product revenue with that in the first quarter of '23, given that it looks like it's sequentially down?

恭喜你的進步。首先，考慮到它看起來連續下降，您能否將 23 年第二季的淨產品收入與 23 年第一季的淨產品收入進行核對？

Yes. I think -- Robert Wessman here. So overall, I would want to maybe use opportunity to explain why we saw the revenues from first quarter to second quarter this year, taking in the first half, we have been prioritizing the FDA inspection we had and the responses to the observations and we clearly pulled some of the key resources away from day to day. So that's one point.

是的。我想——羅伯特·韋斯曼在這裡。因此，總的來說，我想也許利用機會解釋為什麼我們看到今年第一季到第二季的收入，考慮到上半年，我們一直優先考慮 FDA 檢查以及對觀察結果的反應，我們清楚日常工作中一些關鍵資源被撤走。這是一點。

But the main point more importantly is that we have been producing, and we have a large stock of finished goods on hand, which will be shipped in third quarter and fourth quarter this year. Part of this volume was used to validate our increased vat size and is pending regulatory approval in Europe.

但更重要的一點是，我們一直在生產，我們手頭上有大量的成品庫存，今年第三季和第四季就會出貨。該卷的一部分用於驗證我們增加的桶規模，並正在等待歐洲監管部門的批准。

So we expect that this year. So basically, in the second quarter this year, we used the sizable capacity of the business to basically produce inventories, which will be released, as I said, later this year.

所以我們預計今年會這樣。所以基本上，在今年第二季度，我們利用了相當大的業務產能來基本上生產庫存，正如我所說，這些庫存將在今年稍後釋放。

Great. And then just one follow-up. Is it possible to provide any thoughts and anticipated be like filing time lines for 03, 05, 06 and 23?

偉大的。然後只有一個後續行動。是否可以提供任何想法和預期，例如 03、05、06 和 23 的提交時間軸？

Yes, we haven't provided updates for future filing dates, but the next one you could assume would be 06. It's the one that's the most advanced.

是的，我們還沒有提供未來申請日期的更新，但您可以假設下一個申請日期是 06 年。

And the questions come from Thibault Boutherin from Morgan Stanley.

問題來自摩根士丹利的 Thibault Boutherin。

Just a couple on the U.S. market for HUMIRA and biosimilar. Clearly, adalimumab has been holding more volume share in this market than anyone expected, and has had on their perspective, quite a successful contracting strategy. So I just wanted to have kind of an update on your side, on your view on when this market will open to biosimilar in terms of timing. So is it kind of H1 next year? Is it kind of middle of next year? And is there a catalyst? Or is there something specific that could kind of force PBM to become more friendly -- more biosimilar friendly, I would say, and see the kind of share of biosimilar in the volume increase of time? So that's my first question.

美國市場上只有少數 HUMIRA 和生物相似藥。顯然，阿達木單抗在這個市場上所佔的銷售份額超出了任何人的預期，並且在他們看來，這是一個相當成功的承包策略。所以我只是想了解一下您對這個市場何時向生物相似藥開放的看法的最新情況。那麼明年的H1是這樣的嗎？是明年年中嗎？還有催化劑嗎？或者是否有某種特定的因素可以迫使 PBM 變得更加友好——我會說，對生物仿製藥更加友好，並看到生物仿製藥在銷售增長中所佔的份額？這是我的第一個問題。

And the second one, you mentioned the innovative commercial models that we are seeing emerging on the U.S. in biosimilar market. So we saw first [Quva] did something doing something a little bit innovative and Sandoz having this deal with CVS as well. Which both seem to focus on reducing the price discount -- the list price. So do you expect this to be restricted to HUMIRA because of the competitive situation? Or -- could we see this type of deal, in your view, becoming more prevalent on the U.S. biosimilar market? And is it impacting in any way how you are thinking about your own commercial strategy in partnership with Teva for the U.S. market?

第二個問題，您提到了我們在美國生物相似藥市場上看到的創新商業模式。因此，我們首先看到 [Quva] 做了一些有點創新的事情，Sandoz 也與 CVS 達成了這項協議。兩者似乎都專注於降低價格折扣——標價。那麼，您是否認為由於競爭情況而僅限於 HUMIRA？或者，您認為這種類型的交易在美國生物相似藥市場上會變得更加普遍嗎？它是否會以任何方式影響您如何考慮與 Teva 合作針對美國市場的商業策略？

Thank you, Thibault. Anil is here, let me take your questions. On the first one, you are right, the conversion has been relatively limited for the biosimilars. We have believed that while adalimumab remains primary on the formulary noninterchangeable products and particularly the low concentration forms would have a difficult time converting large pieces of the market, even despite formulary positions. We have been very consistent on that. So we do not -- we are not surprised with this situation as of now. We continue to believe that a high concentration interchanging with adalimumab would be more efficient in converting market even without this current formulary position. So we see adalimumab more like in 2024 material event for Alvotech.

謝謝你，蒂博。阿尼爾來了，讓我回答你的問題。關於第一個，你是對的，生物相似藥的轉化相對有限。我們相信，雖然阿達木單抗仍然是處方不可互換產品的主要產品，特別是低濃度形式，但即使有處方地位，也很難轉換大部分市場。我們在這一點上一直非常一致。所以我們對目前的情況並不感到驚訝。我們仍然相信，即使沒有目前的處方地位，與阿達木單抗的高濃度互換也會更有效地轉換市場。因此，我們認為阿達木單抗更像是 Alvotech 2024 年的重大事件。

On your second question, at this stage, what I would like to say and have said in the earlier remarks is that the story of HUMIRA biosimilars is still being written. We believe that the market will find their way ultimately to support by biosimilars and within that market, we continue to believe that differentiation matters. Of course, there is a potential for other type of arrangements, but I wouldn't want to comment further on that. What I can say, we have probably the best commercial partner in the U.S. market, together with our partner, Teva, we are exploring multiple approaches, but I wouldn't want to telegraph that at this stage.

關於你的第二個問題，現階段我想說的是，並且在先前的演講中也說過，HUMIRA生物類似藥的故事仍在書寫中。我們相信市場最終會找到生物相似藥的支持，在該市場中，我們仍然相信差異化很重要。當然，也有可能進行其他類型的安排，但我不想對此發表進一步評論。我可以說，我們可能擁有美國市場上最好的商業合作夥伴，與我們的合作夥伴 Teva 一起，我們正在探索多種方法，但我不想在現階段透露這一點。

We continue to stay engaged with the market are also laser focused on the FDA approval, which will be perquisite to test our strategies. Thank you.

我們繼續與市場保持聯繫，同時也高度關注 FDA 的批准，這將是測試我們策略的必要條件。謝謝。

(Operator Instructions) And the questions come from Niall Alexander from Deutsche Bank.

（操作員說明）問題來自德意志銀行的 Niall Alexander。

Niall Alexander from Deutsche Bank. Two questions, please. Just wanted to confirm when we would receive guidance -- FY guidance? I'm guessing we may not receive it this year, but would we receive a sort of for FY '24? Or can you give any guidance whatsoever this year? That's the first question.

德意志銀行的尼爾·亞歷山大。請教兩個問題。只是想確認我們何時會收到指導──財年指導？我猜今年我們可能不會收到它，但是 24 財年我們會收到某種形式的嗎？或者今年您能提供任何指導嗎？這是第一個問題。

And then second one would be good to get your -- if you could provide any color and thoughts into potential pricing of AVT02 subject to approval in the U.S.

然後，如果您能對 AVT02 的潛在定價提供任何顏色和想法（需在美國獲得批准），那麼第二個將很好地得到您的支持。

This is Joel. So I can answer the first question. I think as highlighted in my opening remarks, we have quite a number of positive items that we have in our outlook that are still bound by uncertainty in terms of timing which is what's driving our not providing guidance at this time, though we are excited for them to play out in our near future.

這是喬爾.所以我可以回答第一個問題。我認為，正如我在開場白中所強調的那樣，我們的前景中有相當多的積極項目，但它們仍然受到時間上的不確定性的影響，這也是我們目前不提供指導的原因，儘管我們對此感到興奮他們將在不久的將來發揮出來。

That being said, in terms of the timing of when we expect to provide guidance, as you've heard from me in the past, I think the timing of U.S. approval, in particular, is a large driver. It is a material driver of top line and bottom line for our company. And so I can't tell you right now exactly when it is we'll be in the best position to provide guidance, but I think you can expect that it will largely be connected to the timing of approval and commercial contracting so that I can be more precise with giving guidance.

話雖這麼說，就我們預計提供指導的時間而言，正如您過去從我那裡聽到的那樣，我認為美國批准的時間尤其是一個重要的推動因素。它是我們公司營收和利潤的物質驅動力。因此，我現在無法準確地告訴您，我們何時最適合提供指導，但我認為您可以預期，這將在很大程度上與批准和商業合約的時間相關，以便我可以給予指導更加精準。

I can take the second question. In terms of pricing, of course, we cannot give a guidance. As I said before, we have the best commercial partner in the U.S. market. Teva has been very successful with both biosimilars as well as with the specialty products in the U.S. market. They have a very clear pricing strategy when it comes to AVT02. Also, we have very good engagements with the players when it comes to pricing and different models. So we have pretty good visibility on that, but I would not like to give a guidance at this stage.

我可以回答第二個問題。當然，在定價方面，我們無法給予指導。正如我之前所說，我們在美國市場擁有最好的商業夥伴。梯瓦製藥在美國市場的生物相似藥和特色產品方面都非常成功。對於 AVT02，他們有非常明確的定價策略。此外，在定價和不同模型方面，我們與玩家進行了很好的互動。因此，我們對此有很好的了解，但我不想在現階段提供指導。

(Operator Instructions) And the questions come from the from Andrew Baum Citi.

（操作員說明）問題來自 Andrew Baum Citi。

Two questions. Number one, should I assume, that CVS will now only be contracting with Sandoz for biosimilars for adalimumab following the Novartis announced JV?

兩個問題。第一，我是否應該假設，在諾華宣布成立合資公司之後，CVS 現在只會與山德士簽訂阿達木單抗生物相似藥合約？

And then second, obviously, there are two other major PBMs that cover with CVS, 80% of covered lives in the U.S. To my mind, neither of those was yet to sign a similar deal. Are you in active discussions with either of them in a similar tax structure as the one that Sandoz has entered?

其次，很明顯，還有另外兩家主要的 PBM 涵蓋了 CVS，涵蓋了美國 80% 的生活。您是否正在與他們中的任何一個人就與山德士所進入的稅收結構類似的稅收結構進行積極討論？

Thank you for the question. I would like to say, as also iterated before, HUMIRA market in the U.S. is still being written. So we have, of course, to have multiple interactions going on with all the players you named and some of them you didn't named. So we clearly understand their expectations, and we are flexible in our approach. But we believe that AVT02 is still going to be a substantial opportunity both for Alvotech and for us. And I would like to also remind that still today, Alvotech is the only candidate to bring the best product profile to the U.S. market with our interchangeability designation, with our device and with all other features that we have added in our product that we believe is going to be appreciated by the payers and the U.S. market.

謝謝你的提問。我想說的是，正如之前所重申的那樣，HUMIRA 在美國的市場仍在書寫中。因此，當然，我們必須與您提到的所有玩家以及其中一些您沒有提到的玩家進行多次互動。因此，我們清楚地了解他們的期望，我們的方法也很靈活。但我們相信 AVT02 對 Alvotech 和我們來說仍然是一個重大機會。我還想提醒的是，直到今天，Alvotech 仍然是唯一一家將最佳產品配置帶入美國市場的候選者，我們的產品具有可互換性，我們的設備以及我們在產品中添加的所有其他功能，我們認為這些功能是將受到付款人和美國市場的讚賞。

We have no further questions at this time. I will now hand back to Mr. Benedikt Stefansson for closing remarks.

目前我們沒有進一步的問題。現在我請 Benedikt Stefansson 先生致閉幕詞。

Thank you, Marcia. On behalf of the Alvotech team, I would like to thank all the participants in our webcast today and the participants on the Q&A. We wish you a good rest of the day and look forward to speaking to you all again. Thank you.

謝謝你，瑪西婭。我謹代表 Alvotech 團隊感謝今天網路廣播的所有參與者以及問答的參與者。我們祝您今天休息愉快，並期待再次與大家交談。謝謝。

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

謝謝。今天的電話會議到此結束。感謝您的參與。現在您可以斷開線路。謝謝。