Alvotech

Good day and thank you for standing by. Welcome to the AlvoTech Q4 and full year 2023 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 11 on your telephone keypad. You will then hear an automatic message advising your hand is raised. To withdraw a question, please press star 11 again. Please be advised that today's conference has been recorded. I would now like to hand the conference over to a speaker today, Benedikt Stefansson. Please go ahead.

Thank you, and 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.avotech.com. The release outlines key highlights related to our full year 2023 results. Additionally, we will, throughout today's call, refer to a slide presentation, which is available on our investor website in the events section. If you have not already accessed the slides, please go to investors.avotec.com and select events. 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 to differ materially from forward-looking statements that we make. 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.

Thank you, Benedikt, and thank you all for joining us on today's earnings call and business update for the full year 2023. We are very excited about the position that we find ourselves in today. Alvotek has successfully cleared our inspection status with the US FDA. This puts Alva Tech in a position to access the largest pharma market in the world. This result has led to approval of Simlandi in the U.S. and also clears the way for our biosimilar to Stellara, which we expect will be approved by FDA next month. Additionally, our pipeline has been steadily progressing and we are in a position to file at least three applications for new biosimilar candidates this year. And those are just a few of the events that are driving excitement and anticipation here at DalvoTech. But before we discuss in more details regarding 2023 and take a look into 2024, I would like to take a step back for a moment to recap our strategy and positioning. Alvatech is proud to be focused entirely on biosimilars, which position us amongst a small group of companies dedicated to meet the global need driven by the high-cost biologic medicines. Further, we are vertically integrated with end-to-end capabilities and have established a comprehensive infrastructure platform from where we can develop our manufactured biosimilars. Having this dedicated infrastructure will further differentiate us from other biosimilar developers. We also have a multi-product portfolio-based strategy. With our recent launch of Gemtechie, our biosimilar to Stellara in Canada, we have two different molecules now on the market. We continue to grow and advance our overall pipeline and portfolio, which has 11 disclosed assets today. And finally, we have a global regulatory and commercial strategy, as we see biosimilars as both a global opportunity and necessity. A global strategy allows us to maximize the return of our development investment and provides diversification and longer-term durability to our portfolio assets. The hard work and investment that has been put into Alvatech over the past decade has now positioned us at an inflection point where we expect growth in revenues based on multiple launches in major markets, while concurrently advancing a pipeline of attractive biosimilar candidates. 2023 was a year that can be defined as laying the foundation for the future growth. The first element of that foundation is reflected in our global regulatory approvals, which enables a steady schedule of commercial launches for 2024, 2025 and beyond. SymLanti was approved as the first interchangeable high concentration biosimilar to Humira in the US market. And while the approval occurred in 2024, The hard work and dedication from the team to secure inspection readiness in 2023 have to pave the way for this approval. Approval of our Stellera via similar in Canada, Japan and Europe further demonstrates and validates the platform's ability to gain global regulatory approvals on multiple products in major markets. And thus, importantly, these approvals will enable near-term diversification of revenue. For the US, our ABT04 application was reviewed and deemed approvable by FTA. The outstanding issue for approval was a successful site inspection, which was the same as with Zimlandi. The recent approval of Simlan-D provides us significant confidence that AVT-04 will gain final approval in the US in April of this year. Of course, what has enabled these approvals is the dedication of Alvetech team to compliance and inspection readiness. And that is not only for the USFTA, but for all regulatory bodies around the world where we have or intend to launch our products. I would like to thank our entire team at AlvoTech for the efforts made to ensure our positive inspection outcome. In 2023, we also continue to expand and enhance our commercial network through existing and new strategic partnerships. This included an expanded partnership with EVA in the US, as well as with Fuji Pharma in Japan. We also added to our network Advanced Pharma with a strategic partnership covering five proposed biosimilars in Europe. Our strategic partnership with well-established and well-recognized companies are fundamental to our ability to ensure that our products find the right home all over the world. Finally, 2023 was another year of significant advancement for our pipeline. Alvotek started as a development company, and we aim to maintain that scientific resolve as we mature into global commercial phase as an organization. We have received positive clinical results for AVTO6, our proposed biosimilar to ILEA, thus paving the way to a submission later this year. Additionally, we have three other programs in addition to AVTO6 that have demonstrated positive PK results and are currently in ongoing patient trials. Please note that, as a general rule, passing PK results are more informative to potential approval than results from patient trials, and we are highly confident in our ability to bring these products to the submission phase. The proposed biosimilar currently in ongoing patient studies are AVT05, a proposed biosimilar to Symfony and Symfony Haria, AVT03, a biosimilar candidate to Prolia and DexGiva, and also AVT23, a biosimilar candidate to Solar, a product advancing in partnership with CASEID. And finally, we advanced our AVT16 program into one of the leading positions in the fast-growing NTVO market. Looking back at 2023, I can say with great confidence that it has positioned us well to drive growth on both the top line and bottom line in 2024 and beyond. And we are very proud of our achievements in AlgoTech. Now looking ahead, we see 2024 as a transformational year for the company. It starts with launches of major products into large markets. Our launch of Simulanti in the US will occur in early second quarter. And as the only high concentration interchangeable product on the market, we have high competence in this launch. Earlier this year, together with our partner Jump Pharma, we launched our biosimilar to Stellara in Canada with the brand name of Jump Techie. This represents the first launch of Stellara biosimilar in the Canadian market. We aim to launch our Stellara biosimilar in Japan in second quarter of this year and then in Europe beginning of third quarter this year. These multiple launches will bring material revenues into AlvoTech and create diversification of the top line from both markets and products. In addition to the commercial launches just mentioned, we will also be preparing for our launch of AVT04, our Stellara by a similar candidate in the US. While the commercial launch is in early 2025, We will be supplying later in 2024 launch quantities, and we may generate additional revenues depending on supply timing in 2024. But as important as commercial launches are, it is equally important that we continue to drive advancement in our pipelines. 2024 is set to be a busy year in our portfolio as we expect at least three additional submissions in major markets this year. Additionally, in our pipeline, we intend to advance our AVT16 program to the clinical trial phase. Finally, we continue pursuing more business development transactions and remain in active negotiation for available assets in our portfolio. In 2024, we expect to see multiple launches and significant growth in milestone revenues coming from highly visible and de-risked programs. We are now in a position to guide the market for 2024 and 2025 on top line and where we expect to land on EBITDA in 2024. Later in this presentation, our CFO, Joel Morales, will cover guidance in greater detail. I would, with those words, like to turn now the call over to Anil Oke, our Chief Commercial Officer, to dive deeper into our upcoming launches and portfolio updates. Anil, over to you.