Alvotech

Good morning or afternoon to everyone joining this call today. Yesterday evening, the company issued a press release that can be found in the news section of our investor portal, investors.alvotech.com. The release outlines key highlights related to our first quarter results. Additionally, we have posted with the call-in information for today's event, a slide presentation, which we will be referring to during today's call. Please go to the events section of our investor site to download the slide deck if you haven't already done so. 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 and the Nasdaq Iceland Stock Exchange. These risks and uncertainties could cause actual results that 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 to everyone for joining us here today. On our last earnings call, we laid out a list of ambitious goals that we aim to accomplish this year. Today, I will briefly cover each of those goals and our progress towards achieving them. Our team will then provide further details throughout today's presentation, which we hope can give you a sense of the tremendous progress which we have made thus far. Our first initiative is commercializing our biosimilar to Humira in the US market. Our product is interchangeable with the reference product, and we were the first to achieve interchangeability with the high concentration form of Humira, which currently holds the dominant market share in the U.S. market. As a reminder, we have received exclusivity for our approved strengths and expect to maintain that exclusivity into May of next year. Much progress has been made since our last public update. Late last month, we updated the market on our agreement with Qualand, the private label unit for the Cigna Group in the U.S. Evinorth, a wholly owned subsidiary of Cigna, announced that Alvotek product would be offered with a zero out-of-pocket cost and noted that there are over 100,000 patients currently using Humira through Cigna, a critical specialty pharmacy. This partnership is a win for Alvotek, the Cigna Group, and for patients across the country. What we are witnessing today is a rapid evolution of pharmacy benefit biosimilars in the U.S., and we welcome that change. The introduction of private label as a method of commercializing AVTO2 and the increase in conversion from Humira to biosimilars strengthens further our view of the Humira biosimilar opportunity. Furthermore, this evolution speaks to further potential when it comes to other products in our portfolio, including CellArts D, our biosimilar to Stellara, AVT03, our proposed biosimilar to Prolia, and AVT05, our biosimilar candidate to Symfony. In addition to the private label contract, our commercial partner Teva is making great progress on formulary discussion, and we believe we will be well positioned this year with our interchangeable product. Contracting on the formulary business is well advanced, and details on final formulary position will likely be announced by the PBMs themselves on or around July the 1st. As of today, I'm happy to say that we have received binding purchase orders for over a million units to support our launch of the biosimilar to Humira in the US market. And we have announced that we have already started to supply our partners with our interchangeable high concentration biosimilar in the US market. As excited as we are for our launch of Biosimilar to Humira, we are equally excited at the opportunity for our second product. Keep in mind, Alvotek's strategy is to have a broad portfolio of products offered in almost every market in the world. The global launch of our second product helps demonstrate to the market our long view of Biosimilar as we establish ourselves as a preferred partner in this rapidly growing and evolving space. With AVT04, we have received approvals in all major markets. We have already launched or are actively preparing to launch this product across all major markets within the next 10 months. We have now launched our Buy Similar to Stellara in Canada. We just recently did in Japan. In Europe, we start in July this year, and in the US, we are starting to launch in February 2025. Although we are focused on the near-term commercial opportunities, we must also continue to advance the pipeline to make sure that we have consistent year-over-year growth in mid- and long-term. And 2024 is set to be busiest year in the history of Alvatech for our pipeline. We expect at least three additional filings in major market this year. This pipeline success brings near-term revenues to the business, but more importantly, it allows us to drive further growth and diversification in the business. And looking forward, we continue to work on business development deals for remaining licenses. We are happy to have announced recently that we partnered with Dr. Reggie's laboratories on AVTO3 for the U.S. and European markets. AVTO3 is our proposed biosimilar to ProLi and Xtiva, and we expect to file the application later this year. The transaction will generate significant milestone revenues this year due to the advanced status of the development and also secures a key partner in a critical market for our mid-term portfolio. I want to welcome Dr. Redis to our family of partners, which now stands at 19 globally and which covers over 90 markets around the world. And finally, on our year-end call, we provided guidance for 2024 and 2025. Based on the progress we are seeing on the commercial front and in our pipeline, We are in the position to raise the top-line guidance for 2024 to $400 to $500 million. And furthermore, we are tightening our EBITDA guidance from $50 to $150 million to $100 million to $150 million for the year 2024. With our multiple launches and more clarity on commercial and regulatory, Alvotek currently sits at an inflection point. where we are transitioning the company from R&D company into full-scale global commercial biologic company that we have always hoped to be. We could not be more excited at the opportunity that BioSimula presents, and I would like to pass the presentation over to Anil Oke, our Chief Commercial Officer, to provide further details on progress that we have made.

Thank you, Robert, and thank you for those joining today's call. I would like to start by providing further details on our exciting launch of biosimilar to Humira in the US market. As we have said on previous calls, our product profile has allowed us and our partner Teva to have broad engagement with the US market. That engagement is starting to bear fruit. Having interchangeability with exclusivity to the dominant firms on the market, combining that with a premium auto injector that is also deemed as interchangeable, and having dedicated manufacturing capacity for biosimilars has put us in a position to address both private label and non-private label business. On the private label part of the market, we are very excited to have teamed up with Qualand, which is the private label arm for the Cigna network. In late April, Evernote, a wholly-owned subsidiary of Cigna, announced that they will be making available Humira biosimilars at zero out-of-pocket costs through their Acrido speciality pharmacy, which supports over 100,000 patients currently utilizing Humira. It goes without saying that we are very excited about this partnership with Qualent and the Cigna Group. The changing environment in pharmacy benefit biosimilars is, in our view, a positive development not only for Humira, but also for future pharmacy benefit products, of which we have a number in our portfolio. Because of the unique nature of the arrangements, which was not contemplated in our original partnership with Teva, we have mutually agreed to change the economics from a revenue share model to a cost plus profit share model, which makes more sense for this type of arrangement where the payer is actually taking ownership of the product itself. The program kicks off in June and we have begun supplying our partner with products. On the non-private label side, we are excited to introduce with our partner Teva Simlandi, which is an interchangeable high concentration biosimilar to Himira. While I cannot provide specific updates on today's call, what I can say is there is positive momentum and we expect substantial coverage in the market to include at least one large payer These changes, once finalized, will take place on 1st of July and we expect that an interchangeable biosimilar to the high concentration form can drive uptake in the second half of the year. The product is now formally launched as of Monday by our partner Teva and we look forward to providing updates as we move through the year. As Robert noted, we have exceeded 1 million units in binding purchase orders for our Humira biosimilars in the US market, which shows the commitment by our partners to drive biosimilar uptake within the Humira market. Moving to the second objective that Robert mentioned earlier, we are very pleased at the continued progress with our biosimilar to Stellara. First, in the U.S. market, Celarsdi has been approved, which marks the second approval in the U.S. market for Allotec and the second product to gain approval under our partnership with Teva. Currently, only Amgen has secured approval for a Stellara biosimilar in the U.S. We have a license date of February 21st of next year, and our commercial supply production has already begun. We expect to initiate supply of Celarsity to our partner in Q4, which is the trigger for our revenue recognition. We also expect to gain interchangeability for Celarsity and expect to get designation either at the end of this year, which would be in time for our launch date or shortly after launch. Timing of interchangeability designation hinges on the FDA's interpretation of the BPCIA and provisions that determine exclusivity timelines. In either case, we believe we are in a strong position to address this high-value market on a product that costs over $150,000 per patient per year in the U.S. And of course, as excited as we are with StellarCity, we view StellarO opportunity through a global lens. We have launched our StellarO biosimilar in Canada, March of this year, under the brand name Jumpteki. Our partner in Canada is Jump and currently Enjin is the only other approval. In Japan, we have launched AVT04 this month through our partnership with Fuji Pharma. In Europe, We are approved in all markets and have planned launches commencing in Q3 of this year under the brand name of Usprova. We believe we are well positioned in all of those markets to be on the leading edge of the market formation, which puts us in a good position to compete broadly. We also feel, particularly in Europe, that the introduction of biosimilars can have a meaningful positive impact in overall growth of the molecule, as Stellara is a particularly high-priced product. Please keep in mind that Humira biosimilars helped contribute to four years of double-digit volume growth, and we see that biosimilars may have a similar, if not more significant impact in ex-US volumes for ustekinumab. Moving to the next slide, I would like to discuss the progress expected within our pipeline for 2024. AlvoTec is a young company, and for the first time in our history, we have a visible schedule of multiple high-value launches across multiple products and markets. This is truly an exciting time for the company. But while these launches are crucial, the ongoing advancement of our pipeline is essential to ensuring our continued success in the years to come. And 2024 is shaping up to be a banner year for our R&D team that has already demonstrated their ability to navigate the global regulatory environment with efficiency and purpose. This year, we are expecting three additional filings in major markets, starting with AVT06, our biosimilar to Eylea, a leading product in the ophthalmology space, Unlike Humira and Stellara, which are primarily pharmacy benefit products, Eylea is a medical benefit medicine in the U.S. The recent success of the Lucentis biosimilar in accessing the U.S. market, we think, is an important precursor to Eylea biosimilar adoption. We also expect to gain interchangeability for Eylea in a similar fashion as biosimilar Lucentis. Finally, it is important to note that we are also developing the high-dose form of Eylea. While we are not expecting submission this year, it is again validation to the market that Alvotec remains nimble in our development programs and dedicated to biosimilars broadly. We believe having high-dose form of Eylea will differentiate Alvotec in the marketplace. This forward-looking message and commitment to future biosimilars we believe impacts our current discussions in the market and that applies to all global markets. We are also expecting to file AVT03, our biosimilar to Prolia and Xgeva. While it is the same development program, there are two distinct market segments here as both a pharmacy benefit product and a medical benefit product as well. On Tuesday, we announced jointly with Dr. Reddy's laboratories that we have finalized a licensing agreement for the US market and the EU market. Dr. Reddy's is a multinational pharmaceutical company with a substantial presence in the US and in Europe. We are excited to welcome Dr. Reddy's as our partner for AVT03 in the US and in Europe. and look forward to further updates on the program. Moving on to AVT05, we recently announced positive top-line results on our patient trial, which provides us significant confidence in the finalization of this program in 2024. AVT05 is a proposed biosimilar to both Sympony and Sympony Aria, which also makes it a combination pharmacy benefit and medical benefit product. Again, we intend to seek interchangeability for our biosimilar candidates. For this program, I would like to highlight a couple of very important points. First of all, there is only one other company that we are aware of that has registered a patient trial. Secondly, only a handful of companies can boast having Humira and Stellara biosimilars in their portfolio. Moreover, no company can claim to have a portfolio that includes Humira, Stellara, and Symfony. This is yet another example of our portfolio approach to the market, which we believe fosters a welcoming environment in discussions with customers, by both ourselves and our partners. Finally, I would like to add that all of the progress you see in our pipeline will lead to substantial revenue for the company, and we expect significant impact from the milestones in 2024 with a sharp increase expected in the second quarter. Moving to the next slide, I would like to briefly touch on our longer-term portfolio. With regards to AVT16, our proposed biosimilarity NVO, we remain on track to initiate patient trials this year. There is currently only one other registered patient trial that we are aware of, and this is for a brand that has been rapidly beating market expectations year over year. Initiation of patient trials for AVT16 should also generate milestone revenue in 2024. Looking longer term, we continue advancing a number of programs, including AVT33, or by a similar candidate to Kate Ruda. As a reminder, AlvoTech aims to add one to two products every 12 months, which we believe is the optimal pace to sustain long-term growth for the company. Finally, I would like to close my portion of our prepared remarks by covering the fourth key priority that Robert mentioned in his opening statement, and that's regarding our ongoing business development efforts. I'm very proud of the fact that we have been able to build a global commercial presence through a network of sophisticated and knowledgeable partners that allow our portfolio access in nearly every market around the world. This has continued recently, as I have just mentioned, with the addition of Dr. Reddy's partnership into our network of various partners. We are extremely proud of our pipeline, which we consider one of the most extensive in the industry. Our next major target is to continue to partner our future pipeline programs, including AVT33, which is our K2 biosimilar candidate. We remain in ongoing conversations with multiple parties for global commercialization rights and hope to provide updates when progress is finalized. Outside of Keytruda, we continue engaging potential or existing partners for our long-term portfolio in markets, both large and small. And with that, I would like to turn the call over to Joel Morales for a financial update.