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| Statement |
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| Then the nature of those discussions, I can say, are very positive and we believe strongly that we will gain broad formulary access |
| 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 also showed you more details on our device platform that we believe is another advantage, connected to interchangeability because we believe interchangeability matters even more with our device platform because our device is really unique and very patient-friendly |
| Alvotech, along with our partners around the world, are extremely excited at the opportunity to bring these products to market |
| The enhancement of our pipeline not only provides a basis for longer-term growth but generates near-term milestone revenue which is another core part of our business model |
| As you very well know, we have been very successful in doing that in HUMIRA case and a few other assets |
| Furthermore, our organization's ongoing success in obtaining global approvals underscores a powerful message to every market we enter or intend to enter |
| In Q2, however, we are expecting to see some initial uptake in product revenues due to our planned launches and we anticipate achieving a number of milestone recognition triggers in the quarter which will drive a significant increase in total revenues and we expect to achieve positive adjusted EBITDA |
| And based on our product profile that includes the combination of high concentration and interchangeability, we are highly optimistic that we will gain broad market coverage |
| We -- in our active discussions, we see that the payers are more and more appreciating interchangeability, that was a really very positive recognition from our perspective |
| And we are highly confident in our ability to bring these products to the submission phase |
| and we believe that our overall strategy for SIMLANDI has put us in a good position to gain broad coverage in the U.S |
| The hard work and investment that has been put into Alvotech 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 |
| We anticipate an exciting year ahead as we continue to transition into a global full-scale commercial operation launching multiple products into markets worldwide, while at the same time, advancing our pipeline |
| And we are very proud of our achievements in Alvotech |
| The company also recorded $42.7 million in milestone revenues in 2023, largely driven by the recognition of $31.6 million of milestone revenues in the fourth quarter as a result of the positive top line results we achieved on the clinical efficacy and safety study for our AVT06 program, a biosimilar candidate to EYLEA |
| Approval of our STELARA biosimilar in Canada, Japan and Europe further demonstrates and validates the platform's ability to gain global regulatory approvals on multiple products in major markets |
| We have received positive clinical results for AVT06, our proposed biosimilar to EYLEA, thus paving the way towards submission later this year |
| The recent approval of SIMLANDI provides us significant confidence that AVT04 will gain final approval in U.S |
| Finally, 2023 was another year of significant advancement for our pipeline |
| We are very excited about the position that we find ourselves in today |
| In 2024, we expect to see multiple launches and significant growth in milestone revenues coming from highly visible and derisked programs |
| 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 |
| We view this approval as a victory for patients in the U.S |
| And secondly, having exclusivity is, of course, giving us a natural advantage in the market space |
| And finally, we advanced our AVT16 program into one of the leading positions in the fast-growing Entyvio market |
| Finally, as we look forward to 2025, we expect to be able to double our total revenues year-over-year as we intend to continue expanding upon our launches within existing and new markets |
| as we believe the product profile that combines interchangeability with the high concentration strengths will help expand conversion in the U.S |
| and help drive expanded use of biosimilars in the HUMIRA market |
| We anticipate that this increase in volumes will have a favorable impact on cost of product revenues, particularly as we increase absorption of our fixed costs |
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| We expect Q1 total revenues to be lower than Q4 2023 |
| This is driven by a slowdown in production to prepare for the FDA inspection in Q1 and prioritization of development batches to enable our planned submissions in 2024 |
| Accordingly, we expect Q1 to be the lowest quarter of the year in terms of revenue and negative adjusted EBITDA |
| These risks and uncertainties could cause actual results to differ materially from forward-looking statements that we make |
| Firstly, you can expect this year to be lumpy in terms of our operating results |
| The outstanding issue for approval was a successful site inspection which was the same as with SIMLANDI |
| I will not be able to provide you the details of that |
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