Alvotech

Welcome to the second quarter 2020 free earnings call for Alvatech. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you need to press star 1 and 1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, you can please press star 1 and 1 again. Please note that today's conference is being recorded. I would now like to introduce and end the conference over to Mr. Benedik Stephenson, Senior Director of Investor Relations and Global Communications of Alvatech. Please proceed.

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.albotech.com. The release outlines key highlights related to our second quarter results. Additionally, presentation slides that cover our call today have been posted on our website in the events sections of investors.albotech.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 Alvotek's control and 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 Alvotek, Anil Oke, 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 Westman, Founder, Chairman, and CEO of Alvotek. Robert.

Thank you, Benedikt, and thank you all for joining us here today. Allow me to kick off the two-day discussion by sharing some pivotal updates in our last public communication. To begin with, we have resubmitted the interchangeable BLA for our proposed biosimilar to Humira, also known as AVTO2. 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. The FDA deems our application approvable for both biosimilarity and interchangeability, subject to a positive re-inspection of our facility in Reykjavik, Iceland. We aim to complete a satisfactory inspection during the review period for the submitted application and expect ABT02 to be a material contributor in 2024 if given final approval. Over the course of the past 18 months, Alvotek 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 investment 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 put the company in the best positions for a satisfactory re-inspection. Our team has been supported by qualified expert consultants on site And we have also been working closely with our partner in the US, Teva Pharmaceuticals, to ensure that we are putting the company in the best position to succeed. And while the upcoming 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 as well as for future inspections. 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 Advance, which includes five biosimilar candidates. 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 agreements. Both transactions are executed after substantial due diligence on Alvatech's business and demonstrate the confidence that others have in the future potential of Alvatech. We continue to maintain an active pipeline of business development opportunities as we continue to complete the licensing of our existing pipeline and add further opportunities to our portfolio. Additionally, I'm pleased to report that June of this year, we announced a settlement agreement between Alvatech and Johnson & Johnson with regards to AVT04, or proposed by similar to Stellera, a leading immunology treatment globally. This agreement grants Alvatech a license entry date in the U.S. no later than February 21st, 2025. Having this settlement now in place provides IP certainty for our second potential offering in the U.S. market. ABT04 is also filed in 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. 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, ASTIC, the leading shareholder in Alvatech, 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. This transaction underscores the company's 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 Alvatex stock in Iceland moved from the first north growth market to Nasdaq, Iceland's main market. We noted at the time that this might lead to inclusion in both domestic and international stock market indexes. In February this year, MSCI announced the addition of Alvatec stock to the MSCI Frontier Market Index. In June, Alvatec stock was added to the domestic index here in Iceland, which includes the top 10 share ranked by trading volume on the Nasdaq Iceland main market. On August 18, Fuji Russell announced that Alvatec stock is being considered for potential inclusion in several of the Fuji Global Equity Emerging Europe Index Series, including the all-world large cap and total cap indexes. The proposed inclusion may be subject to revision at the close of business day tomorrow, and the final change will be known by Monday, September 4th. The food syntax changes will then become effective on Monday, September 18th. 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 Okai, our Chief Commercial Officer, to provide further updates on the business. So over to you, Anil.