Good day, and thank you for standing by. Welcome to the Alvotech Q1 2025 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions]. 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 Alvotech'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 & 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 #2 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 Wessman, Chairman and Chief Executive Officer of Alvotech; Anil Okay, 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 Wessman. 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 SDRs, equity equivalent, on Nasdaq Stockholm Market. 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 Alvotech's shareholder base and increase liquidity for Alvotech's shares. Trading in Alvotech SDRs in Stockholm is expected to begin on May 19. 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 Cimzia biosimilar, which is part of our acquisition of Xbrane'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 million to $700 million, and the 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. Alvotech is, therefore, self-funded in 2025 for the first time. The second message relates to our performance of biosimilar to Stelara. In the late February, we launched our Stelara biosimilar in U.S. market after a…

Thank you, Robert. Starting this year, Alvotech has significantly increased its pace of development. We now have seven unique molecules in early phase preclinical or clinical development in addition to the two molecules already launched and four molecules already filed. Our total addressable market is currently estimated at over $185 billion. This does not include the 15 unique molecules for which we have already completed cell line development. Based on publicly available information, we believe that Alvotech has one of the broadest pipelines in the industry. These products are selected for high potential in markets that are still growing and where we expect to be early movers and with a differentiation. Recent additions to our portfolio are attractive for our partners from a technology, indication, and market potential perspective. We are in active discussions with multiple partners on new licensing deals regarding the earlier stage portfolio and expect to see the benefit of new contracts in Alvotech's P&L later this year. Regarding our marketed products, let me first start with a brief summary for the U.S. market for Humira. We saw a strong uptake of Humira biosimilars in the U.S. within 2024, and we view 2025 as another transformational year for the market. After the slow uptake of Humira biosimilars in the U.S., in 2023, the market transformation only started at the time of our SIMLANDI launch in May last year. SIMLANDI was, of course, the first high concentration citrate free interchangeable biosimilar to Humira in the U.S. market. Conversion to biosimilars in the Humira market started accelerating in the second quarter of last year. By year end, the penetration of biosimilars reached at least 21% of the overall Humira market in the U.S., with our shipments alone in 2024 representing about 12% of the total demand for Humira and…

Thanks, Anil. I'll now provide a summary of our operating performance for the period ending March 31, 2025. On the following slide, you will find a summary of our adjusted operating results, where we show key non-IFRS P&L line items and metrics for the full-year. For reference, IFRS reported financials and reconciliations to our adjusted results are included in the slides in the appendix of this presentation. We achieved a strong $110 million in product revenues during the first quarter, an increase of $97 million or 784% versus the same period in the prior year. This increase was driven by the timing of our launches of biosimilars to Humira and Stelara in the U.S., where shipments of product started to materialize in the second half of 2024 and continue throughout the first quarter of 2025. During the first quarter, we continued to ship our biosimilar to Humira to our U.S. partners based on orders received. As a reminder, our commercial model is B2B, so there can be inherent lumpiness associated with timing and quantities of purchase orders quarter-over-quarter. We also shipped additional volumes of our biosimilar to Stelara to our U.S. partner during the quarter in support of the recent February launch. As Anil mentioned, in the short time since the launch, our partner has secured key contracts, and we look forward to providing further updates as they expand upon the launch in the U.S. throughout the year. We also experienced continued penetration of our biosimilar to Stelara across Europe. Our commercial partner has been successful in positioning our biosimilar as #1 or #2 by market share across multiple European markets, and we continue to fulfill orders in the first quarter. Additionally, reorders for our biosimilar to Humira, which was first launched in Europe in 2022, increased in the quarter…

Thank you. [Operator Instructions]. We will now take the first question from the line of Ash Verma from UBS. Please go ahead.

Hi, good morning. This is Di calling on behalf of Ash. Congrats on the quarter and congrats on getting the interchangeable label. I have two questions on biosimilar to Stelara, if I may. So the first, can you help clarify the interchangeable exclusivity? And how does that trigger specifically? And can your -- like competitor like Sandoz also get interchangeable label for their biosimilar to Stelara? And what will be the value position of SELARSDI if Sandoz also gets the interchangeable label? And then the second question also on the biosimilar to Stelara. I know you guys have talked about like you're working on the private label deal. But what's your -- I guess what's your latest thoughts on when the PBMs may drop the brand from their plans? Thank you.

Thank you very much for the questions. Anil speaking. So let me start with the first interchangeability question. Yes, we are very happy that we got our interchangeability designation as 30th of April. So the Amgen's exclusivity has expired 30th of April. We have not seen all our competition yet getting the interchangeable designation, but we would, of course, expect some of them getting it. But from our perspective, this is very positive news to drive faster uptake throughout the year. When it comes to your second question, we have multiple active sales dialogues still continuing on the private label partners. And what I can say is that at least we are expecting more moves from the PBMs excluding Stelara from the formularies. If this happens, of course, this will open more opportunities for the biosimilar players. But from our perspective, we continue to have the dialogues. And if the brand is excluded, we will see this as a big opportunity for the uptake.

Great. Thank you.

Thank you. [Operator Instructions]. The next question comes from the line of Carl Byrnes from Northland Capital Markets. Please go ahead.

Thanks for the question. And congratulations on the quarter and the progress. I'm wondering if you can quantify to your best ability what the buyout of stocking might have been for the Stelara biosimilar is largely in the first quarter, given the $110 million net product sales? Thanks.

Hi, Carl, thanks. This is Joel. I don't know if I would necessarily describe stocking. So we don't -- I wouldn't quantify it that way. I think it's important to understand that we are a B2B business, which means that we're shipping against purchase orders, right, that we receive against our commercial partners worldwide. So there can be inherent lumpiness in this business model as our partners ultimately decide timing and quantities shipped based on their own individual underlying commercial dynamics depending on where in the world we're talking about. But that said, I would say that this is driven more by timing of orders rather than stocking.

Great. Thank you.

Thank you. [Operator Instructions]. There are no further questions at this time. I would now like to turn the conference back to Benedikt Stefansson for closing remarks.

Thank you, Sandra. On behalf of the Alvotech team, I want to thank you all for listening to our call today. Have a great rest of the day, and we look forward to talking to you all again. Goodbye.

This concludes today's conference call. Thank you for participating. You may now disconnect.