[Call Started Abruptly] materials and some of our statements that we make today may include forward looking statements. These statements do not ensure future performance and are subject to risks and uncertainties that are outlined in company filings with the Securities and Exchange Commission, and the Nasdaq Iceland Stock Exchange. These risks and uncertainties could cause actual results to differ materially from forward looking statements that are made. With me on today's call are Robert Wessman, Executive Chairman and Founder of Alvotech, who will give you a quick overview and recap recent strategic milestones. Mark Levick, Chief Executive Officer will cover our portfolio and competitive landscape. Anil Okay, Chief Commercial Officer, who will give a commercial update. Joel Morales, Chief Financial Officer, who will review the financial highlights. And finally, Ming Li, Chief Strategic Officer, who will present our newly published ESG portal and ESG disclosures for 2020 to 2021. With that, I would like to turn the call over to Robert Wessman, who is Executive Chairman and Founder of Alvotech.

Thank you, Benedict. I want to welcome everyone to our second quarter earnings call. This is actually our first started call for Alvotech as a public company. We believe that biosimilar stands to benefit the long term as the healthcare systems are struggling with cost. Biosimilars have the potential to help make health care more sustainable. On June 15, we made those deputes at NASDAQ in New York and on June 23, we listed on NASDAQ personal market in Reykjavik, Iceland. Alvotech is the only companies who are listed in both US, and Iceland, and one of the few to play by similar companies with scale that are publicly traded. Alvotech is a company that has taken 10 years and over a billion dollars to build. We have been fortunate to make these investments and built our company mean, meanwhile being private. We are very proud of being on having very strong R&D and manufacturing platform and having pipeline of eight biosimilar sub biosimilar candidates with an addressable market over $85 billion. We employ over 800 people around the world with more than 85% focus on R&D, technical operational quality. Our state-of-the-art facility in Reykjavik is designed to support the growth of our pipeline through 2030. Handling end-to-end manufacturing of products substance, product as well as unfinished. We have established global rates across six continents, and well over 90 countries with a network of pitch team, high quality regional partners that are experts in the home markets. In addition to allowing us to leverage our partners expertise and commercial infrastructure, we are entitled to substantial milestones and approximately 40% of in market sales, of course, the backbone of the company is our leadership team. Although biosimilars are very young industry, they have also been quite blessed to recruit experienced and…

Thank you, Robert. I will be covering our portfolio and it is important to reiterate our global multi product approach. Diversification in both markets and products will be key if we are to create a sustained growth model with biosimilars as we aim to do. Other tests portfolio includes eight biosimilars and biosimilar candidates with a total addressable market of over US$85 billion, based on estimated peak sales of the reference products. After we announced our intention to lift the company, we've launched our first biosimilar announced top line results from clinical and safety studies for one biosimilar candidate and transition to additional proposed biosimilars into clinical patient studies. In addition to the full products, which have either initiated or completed clinical studies, we continue to progress biosimilar candidates in preclinical phases of development, which target respiratory disease, immunology and oncology representing a substantial addressable market. Our first biosimilar AVT02 a high concentration, low volume biosimilar to Humira has now launched in the EU, as Hukyndra and in Canada as Simlandi. Later in the presentation, I will break down the opportunity for AVT02 in the US in further detail. In May, we announced top line results from our confirmatory patient studies, AVT04, ustekinumab, a biosimilar to STELARA, becoming only the second company to reach this milestone. We will also go into this program in a bit more detail in subsequent slides. In July of this year, we initiated a patient study for AVT06, aflibercept biosimilar candidate to EYLEA, a leading ophthalmology therapeutic that has experienced double digit annual growth. In July and August of this year, respectively, we initiated a pharmacokinetic and patient study for AVT03, denosumab biosimilar candidate to PROLIA and XGEVA. The market for these two products, which are two presentations of the same biologic have been growing…

Thank you, Mark. As we have recently announced, Alvotech has started to commercialize our high concentration biosimilar to Hukyndra in Canada and certain European markets. This is a very exciting time for Alvotech as we are adding product revenues in addition to the milestone revenues that we have been collecting as an R&D based B2B company thus far. In April of this year, it was announced that JAMP Pharma group through the biosimilar division launched to NAMI, offering Canadian patients a high concentration biosimilar to Hukyndra. JAMP is a well-established pharmaceutical company in the local market, and markets close to 300 different products in addition to a number of well recognized over the counter products. They have extensive commercial infrastructure, covering all parts of the country and support many of their launches, including Simlandi with JAMP chair, which is the Patient Support Program that's critical to the success of biosimilar launches. JAMP is our exclusive strategic partner in Canada, and not just for adalimumab but also for other biosimilar candidates. The combination of our biosimilars with JAMP well established and well recognized infrastructure and name, we believe sets us up well for accessing the Canadian biologics market. In Canada in NAMI, along with Simlandi’s biosimilar were the first to high concentration in Europe biosimilars to enter the market. And even the originator had not broadly launched the high concentration form in adult patients prior to our launch. In June of this year, we also launched to Humira in France, Germany, Finland, and Sweden, and we have been gradually expanding the scope of our launch in recent days. Our strategic partners Stada is a global company with strong roots and coverage across Europe. Particularly in retail markets, we believe that the reputation and recognition of our partner is an important element…

Thanks, Anil. I'll now provide some brief financial highlights for the period ending June 30, 2022. As mentioned, we closed our transaction with OECD on June 15, which provided the company with net proceeds of approximately $140 million. We closed the period with approximately $128 million of cash on hand as of June 30, which includes proceeds from the transaction, but excludes an additional $25 million of restricted cash we have on reserve to satisfy the requirements of our bond agreement. However, redemptions resulted in less cash contributed from the trust than originally planned. However, as we previously disclosed, prior to the close of the transaction, we explored two financing options to further strengthen our access to liquidity to offset the potential of redemptions. Firstly, we continue to negotiate final terms of a second lien loan facility. Higher redemptions and unexpected global market conditions have delayed this process. However, we are now negotiating final terms of this facility with lenders who are currently in our cap structure, and we expect to have the facility in place by the second half of 2022. And secondly, we've secured a standby equity purchase agreement with Yorkville with the capacity to raise up to $150 million of additional funding for the company that can enhance cash liquidity as well as free float, which are both potential needs resulting from higher-than-expected redemptions. Most recently, in August to further enhance our liquidity profile, our Board of Directors and Shareholder others agreed to settle $50 million of shareholder advances in equity at the original pipe valuation of $10 per share, which we view as favorable terms to the company. Additionally, our shareholders have extended the repayment terms of the remaining $60 million of shareholder loans to coincide with additional capital raises in the future, such as when…

Thank you, Joel. And as Benedict mentioned earlier, I am the Chief Strategy Officer at Alvotech. But more recently, I have been appointed as the head of our sustainability efforts at the company. At Alvotech, we believe that a well-structured sustainability program is essential to the long-term success of our business. We believe this can help identify incremental risks that face us and new opportunities that may create long lasting benefits for all of our stakeholders. Furthermore, we also believe that Alvotech is in a special position to participate in a more evolved sustainability framework. We strongly believe that increased affordability driven by biosimilars can promote the sustainability of healthcare systems globally. Biologics in some markets like the US represent a disproportionate share of pharmaceutical spending when compared to the total share of prescriptions. In many emerging markets, biologics are often not fully utilized due to the high price and limited reimbursement of many of today's effective biologic medicines. In either case, Biosimilars are well positioned to address the need that has arisen from the therapeutic prominence of biologic medicines. Moreover, as Robert noted earlier, there are limited pure play biosimilar companies that exist and therefore there are limited ways to gain direct exposure to what we believe is the promise of biosimilars. In addition to the importance that biosimilars can play in healthcare sustainability, Alvotech has a few additional intrinsic qualities that are relevant when considering a broader strategy around sustainability. The location of our manufacturing site in Reykjavik, Iceland allows access of our main production site to substantial renewable energy resources on an isolated grid. This allows us to easily offset our minimal scope one and two emissions footprint, and thus we have been carbon neutral for scope one and two since 2020. Additionally, the location of our…

Thank you, Ming. And with that, we conclude our formal remarks, and we now open up for questions from the audience.

However, before we start the Q&A session, Mark Leonard will make a quick remark regarding the presentation deck, Mark.

Hello, everyone. I wanted to note that since the drafting of our prepared remarks, there has been a recent addition to the Clinical Trial Registry from Samsung. That includes a switching study for adalimumab utilizing the high concentration form. In the presentation materials that have been made available, that update has been made. For us, this reinforces that we have taken the proper strategy when it comes to addressing the $17 billion US biosimilar market. And with that, I'll turn it over to the Q&A.

[Operator Instructions] And your first question comes from the line of Tybalt Mornan from Morgan Stanley. Please proceed with your question.

Hello. Hi, can you hear me?

Yes, we can.

Perfect. Thank you very much. Well, both on Sunday. I have two questions, please. So the first question is on the launch of the biosimilar Humira in Europe by your partner study. It's obviously a very competitive environment. It's a quite a mature market with established competitors. Have you ever heard this formulation here, but since we launched a few months ago with the hybrids as well, and they struggled to take market share? So I guess my question is, how, what are your expectations for this market? And what market share can you realistically take? Is it possible to see start reaching double digit in markets in Europe? So that's my first question. My second question is, is on the high concentration, what we've seen in Europe is before the launch of biosimilars high concentration was about above 90%, of the volume of Humira and low concentration biosimilar still managed to take 60% market share. So it looks like the high concentration didn't really prevalent by a low dose biosimilar from taking share. So just wanted to kind of, if you could put this in context with the launch in the US. And the third question is, is basically on what kind of reaction reassuring PBMs in the US on your ability to supply because, it looks like you have all the facility and your talents to execute on Alvotech's supply, but obviously, you don't have the track record of some of your competitors such as Amazon, Sandoz and so on, who has been obviously supplying biologics to the market for certain number of years. So, what steps can you take to, in order to reassure PBM spouse, any clients in the US that you that Alvotech can actually supply large amounts of volumes to the market? Thank you very much.

Thank you to both for the questions. Anil Okay speaking Chief Commercial Officer of Alvotech, of course, there are three questions. So I will start with the first one and give you a bit of a flavor regarding our thinking in the US. So the question was regarding our European launch, first of all we are I would like to underline that Stada is a very well established name in Europe. So their brand name as a company is also a very important element in Alvotech success on top of our product profile. As you know, European landscape is different landscape than the US typically the physicians and the buyers would like to see long history of the of the players before they make their decisions. And this is what Stada is really providing here. Last but not least, shudders go to market model in the retail market. So I notice, of course, I will not be able to disclose the details. But Stada there is applying different go to market models, which is basically increasing our chances of success. In a nutshell, we are very happy with the progress we are making in Europe with our commercial partner with Stada. When it comes to the US, and just to remind our launch date is first of July 2023, based on the settlement that we have made with Alvotech. Also, again, just to remind, we are the only company who has successfully announced an interchangeability study on high concentration, sites rate free, low volume adalimumab biosimilar. What we know as part of our conversations with stakeholders, and not only players, but several stakeholders, the product profile that we have is a preferred product profile based on various elements. Therefore, we are very positive. And we are very well preparing for…

Thank you.

Thank you. We will take our next question. [Operator Instructions] And your question comes from the line of Karen from Northland. Please ask your question.

Thank you for the question. And congratulations on your progress. With respect to AVT04, you're looking at the regulatory submission prior to year-end ‘22. Would you expect the commercial launch to be in late ’23? Or would it fall into early ‘24? Thanks.

Thanks. Thank you, Karen, this is Ming Li, Chief Strategy Officer. Thank question. So we haven't [indiscernible] providing specific launch timing expectations outside of adalimumab. So we won't we won't provide, any new launch timing today. Obviously biosimilar market formation tends to be an IP driven event. And the facts here are AbbVie in Europe is sometime in 2024. The main patent expires in the US in late 2023. So that's the patent environment. We certainly want to be ready with our product at the earliest possible date of that that helps answer the question.

Definitely. Thanks so much. And just a follow up and I know that AVT16 and AVT33 Are you an early stage in terms of development, but as you have any comments in terms of potential timeline with respect to confirmatory and PK studies when they would be initiated? Thanks.

Yes, these are all in in preclinical development. So, the most recent news on our first, AVT04, and then and again, we're the AVT05 and AVT06 are going to be next. So I think we're a little bit early to provide any guidance to on AVT16 and AVT33.

Great, thanks. And congratulations, again. Thank you.

Thank you. [Operator Instructions] We will take our next question. And the question comes from Jason Guerra from Bank of America, please ask your question.

Hey, guys, thanks for taking my question. I just wanted to understand perhaps you guys have addressed this before in a public forum and I missed it. But the relationship between the two approval events in the US for biosimilar, Humira, the low concentration and I you guys had the FDA, visit the site for the manufacturing and you're just kind of awaiting approval. Does the low concentrate approval in any way gate? The high concentrate interchangeable action date approval decision in December, just wondering if there's any interlinkage there. Thanks.

Hi, Jason, thank you for the question, I think for just a point of clarification, is that low on both applications or high concentration? So there's no low versus high. The second is another BLA that includes biosimilarity and interchangeability. Mark, I think I'll pass it on to you for further clarification.

Yes. Great. Thanks, Ming and thanks, Jason for the question. So just following on from things clarification, we do have two BLAs, one for the biosimilarity and one for the interchangeability. They are separate BLAs. We're working with the FDA on both those in parallel stream approval processes.

Thanks.

Thank you. There seems to be no further questions. I will hand the call back over to management for closing remarks.

Yes, on behalf of the Alvotech team, I want to thank everybody who participated in today's call and was listening on the webcast. We look forward to seeing you all again. Thank you.

This concludes today's conference call. Thank you for participating. You may now disconnect. Speakers, please stand by.