Alvotech

Good day and thank you for standing by. Welcome to the Alvo Tech second quarter 2025 earnings conference call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be the question and answer session. To ask a question during the session, you need to press star 1 1 on your telephone keypad. You will then hear an automatic message advising your hand is raised. To withdraw a question, please press star 1 and 1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to our first speaker today, Benedikt Stefansson, Vice President of Investor Relations and Global Communication. Please go ahead, sir.

Thank you, and welcome to our listeners. Yesterday evening, the company issued a press release announcing our financial results for the first six months of 2025. A presentation accompanying today's earnings call was also published last night on our investor portal, investors.albotech.com, under News and Events. We will be referring to individual slides during the presentation today. Our press release, presentation, and statements that we make on the call today may include forward-looking statements. Please see our disclaimers on slide number two of the presentation. 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. Any risks and uncertainties could cause actual results to differ materially from forward-looking statements that are made. Presenting on today's call are Robert Westman, Chairman and Chief Executive Officer of Albutech, and Linda Jonstrup, Chief Financial Officer. We also have with us on the call Anil Oke, Chief Commercial Officer, and Joel Morales, outgoing CFO. Robert will begin today's presentation with a summary of the first half of the year and quarter, including financial and business highlights. Linda will cover the financial performance in more detail. Following that, Robert has some closing statements And then the team will be happy to take your questions. And with that, I would like to turn the call over to Robert Westman. Robert.

Thank you, Benedikt. And thanks to everyone for joining us here today. I'm very pleased to have with me today our new CFO, Linda Jonsdottir, who joined our team in July. Linda has a background in finance and corporate leadership internationally, has worked across different industries such as transportation, banking, food technology, and healthcare, both as a CFO and COO and chairman. At the same time, I want to thank Joel Morales for his valuable part in Alvotek's journey as a CFO. We are very pleased here today to announce our operating result for the first half of the year and this quarter. These results confirms our continuing momentum as a leading global fully integrated by a similar company. Alvatech's strong growth momentum in the first half of the year can be attributed to strong reorders, successful product launches, development progress, and improved efficiency in manufacturing. Among the highlights from this quarter, we saw good performance in major markets from our two marketed products. We signed significant partnership agreements for our early-stage pipeline. We increased our revenues in the first half of the year by 30% year-on-year. And we also delivered the fifth consecutive quarter of positive adjusted EBITDA. The cash flow of the quarter from the operating activities reached $77 million, which is an improvement of US dollars 161 million year on year. Product revenues in the first half of the year grew by over 200%, and product revenues in second quarter 2025 grew by 77% year-on-year. Product margin were 33%, driven by new product launches, growth in revenues from existing markets, and increased product volumes. Linda will talk more about these financial results later in the call. Let's now switch gears and discuss the performance of our marketed products. Starting with our buyers similar to Hugh Mira, which is marketed as Simlandi in America and some other parts of the world, and as Hugh Kindra in Europe. In Europe, our partner continues to gain market share with Hugh Kindra, which has now entered its fourth year in the market in Europe. We are quite pleased with the solid performance of the biosimilars despite entering a fairly crowded market back in the year 2022. In the U.S., the Humira biosimilar market started opening up last year when our Humira biosimilar Simlanti was launched. As pharmacy benefit managers, PPMs, are starting to exclude the originator from formulary, we are now seeing an accelerated conversion to Humira biosimilars, which in July had reached over 40% share of the overall U.S. Humira market, as per our estimates. This is in line with our expectations that biosimilar conversion could reach 50% in the US Humira market by year end. At the same time, I'm very pleased to say that Alvatech has the second largest market share as a biosimilar to Humira in the largest market in the world, the US market. We also continue launching this biosimilar in markets outside North America and Europe, and our partners now are selling the biosimilar to Humira in 33 markets globally, and we have gained marketing approvals in 67 markets total, and we are therefore continuing to roll out product into new markets going forward. Our biosimilar to Stellara, AVT04, It's marketed at Celasti in the U.S. and Ous Provo in Europe. We were the first entrant in Europe, Canada, and Japan last year with a very strong result. We launched with Teva in the U.S. market this February. Ous Provo continues to outperform our expectations in Europe. Sales volumes are very strong. and we remain the biosimilar with the first or second largest market share in all the key markets in Europe. The uptake of Stellara Biosimilar in U.S. is progressing as we expected. Biosimilar share reached over 20% of overall Stellara market in U.S. in July as per our estimate. With our product marketed under Stellar's brand by Teva, we are on track with our internal forecast in terms of price and volume. As mentioned on our last call, pricing in Stellar market is quite competitive, with some of our competitors offering pricing that we believe are not sustainable in the long run. We are convinced that our strategy by focusing on product margin rather than volume and market share will prove more successful for all of our stakeholders in the long run. In the U.S., although we have not signed any private label, we have signed unbranded product deals with a few leading players through our commercial partner, Teva. We have marketing application under review in major global markets for AVT03, our proposed by a similar candidate to Prolia and XGiva. AVT05, our proposed by a similar to Symfony and Symfony Aria. And AVT06, our proposed by a similar to ILEA. Finally, our marketing application for AVT23, our proposed by a similar to Solr. is currently under review in UK. We also plan to file with EMA application for ABT23 in third quarter this year. We look forward to provide further information as we near the approval and launch dates for these products. As laid out at the beginning of this year, Alva Tech has decided to ramp up its R&D effort significantly. expanding the industry's most valuable R&D pipeline. In June, we completed our transaction of the R&D operation of X-Brain in Stockholm, and also we bought the rights by a similar candidate, referencing Simsea. We continue to hire into our R&D team both in Sweden and Iceland since then. The result of our enhanced R&D activity can also be seen in the recent partnership deals announced during the quarter. During the quarter, we expanded our partnership with Advanced Pharma. licensing European rights to four biosimilar candidates, referencing Ilaris, Casimta, Simsea, and one undisclosed biologic. ADVANCE has shown great confidence in Alvodac by signing license deals for biosimilar, referencing now more than 10 different biologics. We also announced our second partnership deal with Dr. Reddy's, a collaboration to co-develop, manufacture, and commercialize a biosimilar candidate, 2K-TRUTA. The collaboration will allow us to diversify and mitigate development risk and extend the global reach of biosimilars. Shortly after the end of second quarter, we completed our acquisition of IWS-LEE in Switzerland. This acquisition gives us better control of the full value chain and increases our capabilities and flexibilities in assembly and packaging of our devices. Before I conclude, I would like to extend a special greeting to our many new Swedish investors, as this is the first earnings call held after our official listing of Alvatech on Nasdaq Stockholm. After initial placement of about 7.9 million SDRs on Stockholm market, float on the Stockholm exchange has continued to increase. Shareholders are now able to trade AlvaTax shares on three Nasdaq exchanges in Iceland, in US, and now in Sweden. The listing on the Nasdaq Stockholm further broadens our shareholder base and increases trading liquidity to the benefit of all investors interested in participating in Alvotech's exciting journey. In summary, we are very happy about the result of previous six months and our momentum going into the second half of the year. And with that, I would like to hand the call over to Linda. So Linda, over to you.