Alvotech

Thank you, and good morning or afternoon to everyone joining this call today. Yesterday evening, the company issued a press release that can be found on our website, investors.alvotec.com, under news and events in the events and presentation section. The press release reports financial results for fiscal year 2022 and provides a business update. Additionally, presentation slides that cover our call today will be posted on our website at investorsavotech.com. Please look under news and events for the events and presentation section. 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 20F for the fiscal year ending December 31st, 2022. 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 Westman, Chairman and CEO of Avotek, Havron Fredriksdottir, Chief Operating Officer, Joel Morales, Chief Financial Officer, Anil Oke, Chief Commercial Officer, and Ming Lee, Chief Strategy Officer. With that, I would like to turn the call over to Robert Westman.

Thank you, Benedict, and welcome everyone to our fourth quarter and full year 2022 update call. As you know, I have recently been appointed as a Chief Executive Officer for Alvo Tech. I see this as a seamless extension of Marula's executive chairman. I'm excited to take on this new challenge and continue to drive Alvotek's growth and success in the global biosimilar markets. I'm also thrilled to welcome Havrun Friedrichsdottir to Alvotek as our chief operating officer. Havrun brings a wealth of experience in the pharmaceutical industry, most recently at Teva Pharmaceuticals. Before we move to our business update, I want again to reinforce AlvoTech core competence. AlvoTech is a pure play by a similar platform. I believe we have the infrastructure, the personnel, the processes, and the dedication it takes to be successful in the biosimilar space. Alvotek also takes a multi-product approach with a portfolio and pipeline that currently includes eight 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. And finally, Alvotek 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 Alvatech's global approach will further enhance our top-line growth going forward. At the same time, it will provide scale and flexibility to Alvatech by marketing the same products worldwide. And with that, let us go through some of the highlights of 2022, which was a very meaningful year in our journey. 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 SPAC process. It's also important to note that revenue growth was achieved while investing in the future through the growth of our pipeline. Alvotek were able to secure Jula's first clump state in the U.S. for our biosimilar candidate to Humira. We expect that the AVTO2 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 a satisfactory re-inspection of our manufacturing facility remains the only outstanding item. FDA is expected to begin on March 6th the inspection of our facility in Iceland. This past January, the team hosted EMA inspection that resulted in EU GMP recertification. Collectively, we are equally anticipate the forthcoming FDA inspection and are grateful for the agency's commitment to a timely re-inspection. We also have submitted marketing applications for our proposed biosimilar to Stellera in a major market including U.S. and EU. Those applications have now been accepted by the respective regulatory authorities. Further, we have moved three proposed biosimilar into clinical stage development. These are the biosimilar candidates for ILEA, ProLEA, and XG1 Symphony. 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 infrastructure. Finally, we have implemented an ESG framework at the company that includes board level oversight and transparency through our ESG portal available on our website. As we look back on 2022, we can confidently say that Alvartec has advanced greatly as a global biosimilar company. I'm very proud of the accomplishment of the team and believe strongly that we have put ourselves in a position to drive growth in 2023 and beyond. And with that, I would like to pass the call over to Anil Oke, our Chief Commercial Officer. Over to you, Anil.

Thanks, Robert. Let me provide a brief overview of ABT02, our biosimilar to Humira. 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. In the U.S., we are working closely with our commercial partner, Teva, to prepare for launch, which is expected on July 1, 2023, subject to regulatory approval. 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. 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 optimal strategy. 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 four key pillars. 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 one approved high concentration biosimilar, and we are aware of two other companies that have announced submissions supporting the high concentration form. The second is to combine the right products with interchangeability, which is an important construct for the US market. Interchangeability, we believe, will make it easier to transition patients to the biosimilar. According to a recent report by Cardinal Health, which surveyed HTPs across various therapeutic areas, Over 60% of respondents expressed their willingness to prescribe the biosimilar once it has obtained the interchangeability 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 one year post our launch based on our interpretation of the exclusivity provisions. 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. And finally, we needed to establish commercial presence and have supply reliability. This is why we have partnered with Tela, a well-known, reputable company in both speciality and genetics. Tela 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. 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. The Adalimumab market will be a competitive one. And this is why we believe it's important to have a differentiated strategy that can be successful in this market. 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.