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Alvotech
5/8/2025
Thank you for standing by. Welcome to the Alvotec Q1 2025 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 1 on your telephone. You will then hear automatic message advising your hand is raised. To withdraw your question, please press star 1 1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Benedikt Stefansson. Please go ahead.
Thank you. Welcome to Alba Tech's Q1 earnings call for 2025. Yesterday evening, the company issued a press release including financial results for the first three months of the year. A presentation accompanying today's earnings call can be found on our investor portal, investors.alvotech.com, under News and Events. We will be referring to individual slides during the presentation today. Our press release, presentation materials, and statements that we make 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. 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 Chief Executive Officer of Alvotech, Anil Oke, Chief Commercial Officer, Joel Morales, Chief Financial Officer, and Balaji Prasad, Chief Strategy Officer. With that, I would like to turn the call over to Robert Westman. Robert?
Thank you, Benedikt, and thanks, everyone, for joining us here today. Let me start with a brief note about our announcement this morning. AlvoTech has decided to list SDR's equity equivalents on Nasdaq Stockholm markets. The Stockholm Exchange is one of the most active global trading hubs for technology and life science companies. We see this listing as a service both to our current and future shareholders. Trading in our stock will be more accessible, which we expect to broaden Alvatex shareholder base and increase liquidity for Alvatex shares. Trading in Alvatech SDRs in Stockholm is expected to begin on May 19th. So moving to our near-term outlook, we have received very strong feedback from global partners interested in licensing rights to the new assets in our pipeline. This includes the SIMCIA by Similar, which is part of our acquisition of Axbrain's R&D operation in Sweden. We have therefore decided to revise our full year guidance. Top line revenue guidance from 2025 is raised to $600 to $700 million. And adjusted EBITDA guidance is raised to $200 million to $280 million. There are three key other messages I would like to highlight on this quarterly call. Let me first talk about our financial performance. In the first quarter, we delivered the fourth consecutive quarter of positive adjusted EBITDA and operating profits with triple digit increases in both product revenues and total revenues compared to the same quarter in the previous year. With our strengthening operational performance and positive cash flow from operations during the quarter, We expect to be free cash flow positive in 2025. Alvatech is therefore self-funded in 2025 for the first time. The second message relates to our performance of biosimilar to Stellara. In the late February, we launched our Stellara biosimilar in U.S. market after a highly successful commercial launch in Europe, Japan, and Canada. In most of the European markets where we have already launched, we are either the market leader or hold the second largest market share. A few days ago, we announced that the US FDA has approved our Stellara by similar as an interchangeable with the brands. We remain very excited about the opportunity to grow in the US Stellara market. There is also significant room to grow demand for the stellar biosimilar NX US markets for AlvoTech. The third message relates to our strong medium-term product launches. As we laid out in some details in our year-end earning call, we had three biosimilar filings under review in all major markets, which we expect to launch as soon as possible after approval in fourth quarter 2025. A fourth biosimilar is also under review in UK, and a marketing application will soon be filed for Europe. By early 2026, we will have moved from our current two marketed biosimilars to six marketed biosimilars. Our strong pipeline is further primed for product launches in 2026 and 2027. All of this will of course contribute to further diversification of product revenues. All of above exemplifies our capability for integrated development and manufacturing that Alvatech has built over the past 12 years. It also underlines the advantage of Alvatech's business-to-business model, which gives us the ability to address the entire global patient population through 20 strategic commercial partnerships across 90 different markets. At our year-end call, we also presented ambitious plan which is already in motion to increase the pace of development significantly, moving four to six new biosimilar candidates into in-house process development each year. In summary, we have continued to build significant shareholder value, facilitated by our vertical integrated development approach and vertically integrated manufacturing ability. Our ability to execute new product launches in 2025 and coming years is the result of these investments, coupled with our dedication and focus in pure-play biosimilars. Our increased pace of development is also reflected in increased business development activities. Finally, let me briefly address the impact of potential U.S. tariffs on AlvoTech. Tariffs on U.S. imports of pharmaceuticals are still being reviewed, and pharma imports to U.S. remain duty-free. It is also worth noting that our partnership agreements specify that our products are delivered to our partners ex-works, which means that our partners are responsible for customs clearance and eventually import duties. We expect that if tariffs will apply to pharmaceuticals exported from Iceland, they will not be disruptive for Alvatech or our customers in 2025. Furthermore, given the market conditions and the anticipated tariff impact, We expect that our customers can remain competitive in the U.S. market in the long run. And with that, I would like to turn the call over to Anil Okkay, our Chief Commercial Officer. Over to you, Anil.
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