Alvotech

Thank you and good morning or afternoon to everyone joining us on this call today. Yesterday evening, the company issued a press release that can be found on our investor portal, investors.albotech.com. The release reports financial results for the first half of 2024 and provides a business update. Additionally, presentation slides that cover our call today have been posted on our investor website, and you'll hear our speakers referring to this slide presentation during their comments. You'll find all material posted for this earnings call on our investor portal, investors.alvotech.com, under the news and events menu, earnings calendar due to 2024 earnings. Please note that 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. 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 Avotech, 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.

Robert? Thank you, Benedikt, and greetings to everyone joining us on the call here today. It's a very exciting time at Alvatech. Alvatech is transitioning into global business, which we always intended when we started this venture 11 years ago. For the second quarter and first half of 2024, the company generated record results across the total revenues from product sales Milestone revenues and adjusted EBITDA. The total revenues for the first half of the year were 235.6 million, which represents an increase of over 10 times compared to the same period in 2023. Our first half results were driven mainly by the second quarter performance, where 84% of the revenues for the period were generated. This enabled the company to deliver positive EBITDA both for the second quarter of around $102 million and the first half of the year of around $63.5 million. This is a result which we are all very proud of here at AlvoTech. Contribution to our growth and profitability came from multiple sources, including product revenues from X US Stellara and US by similar to Humira, from both private label and branded channels. At the same time, we are seeing our focus on cost efficiencies bearing a fruit as we scale up production volumes and further utilize our facility. On our last earning call, we noted that we had received binding purchase order of approximately 1 million units for our buyers similar to Humira in the US market. We also noted that we would be supplying that inventory throughout the calendar year 2024. I'm very pleased to update that our current 2024 order book for the U.S. market has now reached approximately 1.3 million units, which is a substantial increase from our previous call. Our result in the second quarter set a record for the company when it comes to revenues and EBITDA, which is in line with our expectations. As planned, Alvatech delivered approximately 20% of the US 1.3 million unit order book during the first half of the year. We expect to deliver approximately 80% of the order book, or over a million units, in the second half. We expect that our third quarter will show a strong volume growth over the second one, and fourth quarter to be by far the strongest quarter of the year in sold volumes. We have scaled up our production capacity at Alva Tech, and the company is in a strong position to deliver towards our order book going forward. In addition, we are seeing strong demand for our biosimilar to Humira in US for the first quarter of 2025. At the same time, we are working with our partners to build plans for the full year of 2025, both for biosimilar to Humira and Stellara. In addition to the product revenue, we continue to show a great progress of our pipeline and new business agreements for our portfolio. This progress allowed for record revenues and milestone for the quarter, which we guided to on our first quarter call. The milestone revenues not only contribute to the current performance, but also serve as an indicator for future success as the products and partnerships come online. It's important to know that the results are simply a function of the consistent execution that you have seen from AlvoTech throughout this critical year. On the next slide of the presentation, you can see the steady accomplishment that we have been occurring throughout the year. This includes regulatory approvals, commercial launches, strategic collaborations, pipeline progress, and refinancing of the company that Joel Morales will be discussing during his remarks. Looking forward to the rest of the year, we expect continued execution on both commercial and R&D fronts, and we will be providing relevant updates as they occur. Moving to the next slide, I would like to mention some of my thoughts on Alvatech's position today. When the idea of Alvatech was created just over a decade ago, there were two fundamental concepts that we believed were critically important. The first was a global portfolio approach to biosimilars. We thought a broad portfolio of global biosimilars would limit overall risk through diversification, but also improve the commercial opportunities for the products that we launch. That portfolio expansion and diversification is well underway today. We now have 47 unique launches across two biosimilars in many global markets, and we are in the very early stage of this growth. Before end of the year 2025, we expect to have at least 70 global launches covering our first two products, and that includes the launch of Cellars D, our biosimilar to Stellara, in the U.S. markets. Furthermore, we are on the track to submit three biosimilar applications in major market by end of 2024, with anticipated revenues from specific markets and molecules starting as early as end of 2025. We estimate that it takes two to four years for any given launch, regardless of size, to peak in revenue. The second fundamental part of our concept was to ensure that we built a platform that would only focus on developing and manufacturing of biosimilars. This means that we are a pure play biosimilar company. Today, we have built a world-class facility where we can develop new biosimilars successfully and at a fast rate. At the same time, we have a full control over the supply chain and the quality. And simply by using our development and production platform, we can leverage what we have built to drive future earnings. Between 2023 and this year, we are expecting to expand production volumes by more than threefold. We are also expecting to submit three new applications, which would be a record for the company. And we are able to do this with headcount remaining mostly flat year-on-year. We believe this leverage can continue as we continue to launch new products into new markets in the future. I would like to thank all of you for joining us here today. And at the same time, I would like to extend my gratitude to the Alvotek team for their relentless effort in driving our company's success. And with that, I would like to pass the presentation over to Anil Okkay, our Chief Commercial Officer, to cover our pipeline and provide commercial update. Over to you, Anil.

Thank you, Robert. I will start today with an update on biosimilar Humira in the US. As a reminder, we are addressing both channels for biosimilar Humira, which includes private label and also formulary business. With the private label, As you may know, we are partnered with Qualand, which is the private label for the Cigna Group, a leading payer in the U.S. market. Through the company's specialty pharmacy, Acrido, the group services more than 100,000 patients that currently use Humira or one of its biosimilars. As a reminder, our BLA was approved in February 2024. And the partnership was formally announced at the end of April. However, the actual launch did not occur until June, with the shipments occurring downstream later in that month. Despite the recency of the launch, we are seeing good traction in the market. In a recent call by the Cigna Group, they noted that after only five weeks, they are seeing approximately 20% of their book transitioning to biosimilars. The progress we are seeing with CVS Caremark within the Humira space and the developments within the Cigna Group, which collectively represents the two largest payers in the US, along with various public statements made by others, reinforce our confidence that the adoption of pharmacy benefit biosimilars is accelerating rapidly in the world's largest market. We believe we are well positioned to capitalize on this momentum. as we expect to have multiple pharmacy benefit products on the market by year-end 2025. In addition to the private label space, we are also addressing the formulary side of the business through the brand Simlandi, an interchangeable high concentration biosimilar version of Humira. As a reminder, we are the first interchangeable high concentration biosimilar version of Humira And we have an exclusivity on our interchangeability up until May 2025. In July, formulary changes occurred in various parts of the market. And we are pleased that Simlandi is now listed as preferred on Express Scripts, Carylon RX, Navitus, and Blue Cross Blue Shield of Massachusetts and Louisiana. This to evolve over time in a favorable manner, and we anticipate further coverage as we move into 2025. We are very pleased with the progress of our partner Teva has made thus far. Teva is the ideal partner for us due to their extensive presence and expertise in the US specialty channels, coupled with their unwavering commitment to advancing biosimilars. Teva is not only our partner on Simlandi, but also our partner on CELARCity are approved biosimilar to Stelara. AVT06 are proposed biosimilar to Eylea. AVT29 are proposed biosimilar to high-dose Eylea. And AVT05 are biosimilar candidate to Symfony, among others. This is a very strategic partnership for multiple products. We look forward to progress on all fronts as the partnership progresses across both channels for AVT02 in the US. And as Robert noted earlier, our order book has reached approximately 1.3 million units for 2024 alone and only for the US market. We are happy with the launch thus far and plan to deliver over 80% of our current order book in the second half of the year. Several key variations filed upon approval of Simlandi have been approved by the FDA in late June, which allows us to easily scale up and automate key downstream activities that will start flowing through in Q3 and expand in the fourth quarter. We will carry that pace into 2025 and we look forward to providing further updates as the year progresses. We are also seeing the order book coming in well for the start of next year, as mentioned earlier, and expect changes in the coverage environment to accelerate going into 2025. As a business to business company, we have good visibility during our binding order period, which is five to six months in advance, and we receive rolling forecasts from our partners beyond that. Further, as a B2B firm, it is important to note that we recognize revenue, open delivery of our product to the partners. This dynamic, coupled with our expectations for market development, strengthens our confidence in both our 2024 guidance and our 2025 revenue projections of 600 to 800 million US dollars. For the next topic, I will discuss our global launches of our biosimilar to Stellara. Earlier this year, we launched in Canada under the brand name Jamteki as the first biosimilar of Stellara into a very limited competition through our partner Jump Pharma and under their BioJump umbrella, which now markets both biosimilars approved under our partnership. Shortly after the Canadian launch and through our partner Fujifarma, we launched AVT-04 in Japan as a first biosimilar to Stellara, and we see no competition on the horizon in this market. And most recently, our partner Stada launched USPRUVO in countries across Europe as the first of its kind in the market. These launches are still in the early days, but even with that said, we have received replenishment orders from all three partners. We are very proud in our ability to execute numerous first in market launches across multiple jurisdictions, all within a five-month period. This achievement showcases our production capabilities and operational excellence that will pave the way for a successful US launch in February 2025. The global launches of our biosimilar to Stellara represent a multi-product and global focus in this rapidly evolving space. We are quickly diversifying our revenue base, and we should see that diversification continue to occur as these launches mature and new launches come to the market, including our expected launch of Celarsity in the U.S. within the next six months. We are very excited about the upcoming U.S. Stellara biosimilar launch and we feel we are more than well positioned to be a leader in that market. We have received our approval for Celarsity in April of this year, which provides ample time to prepare for launch in February of 2025. Moving to the next two slides, I would like to conclude my portion of the presentation with updates on our portfolio. As our commercial footprint continues to grow, it remains crucial to sustain our long-term growth by staying at the forefront of biosimilar R&D. We believe that our comprehensive R&D platform, which encompasses a full range of capabilities and a unique approach, sets AlvoTech apart in the market. Our next product in the pipeline is Eylea, Regeneron's blockbuster biologic that targets retinal diseases. In this market, we aim to launch both the original vial presentation as well as a pre-filled challenge that is better received by physicians that have to administer the product themselves. We are very pleased to have now partnered the product with Advanced Pharma in Europe, which was announced this June. Just yesterday, the company announced that the European Medicines Agency has accepted our ADT06 submission for review. This marks the third biosimilar candidate that Alvotek has submitted in a major market. It is important to recognize that announcements regarding submissions are made open filing acceptance, which can vary in timing after the initial filing. We look forward to providing updates as the program continues to progress in Europe and other markets, including U.S. The next product to discuss is the high-dose version of Eylea. High-dose Eylea, which offers less frequent dosing, was launched by the originator in August 2023 in the U.S. The conversion of the market has been steady, and based on recent quarter results for Regeneron, it appears to have captured just under 20% of sales. We aim to be the first high-dose ALEA biosimilar to the global markets, which would represent tremendous opportunity for AlvoTech and its alliance partners globally. AVT29 is also part of our collaboration with Teva and Advance. We have developed a formulation and are currently manufacturing scale-up batches which we believe is an advanced position. We believe this is a direct result from starting our development program well in advance of the originator launch. As we continue the development, we look forward to providing further updates on this exciting program. The next opportunity I would like to discuss is our proposed biosimilar to Symfony and Symfony ARIA. Symfony has been developed using the same platform as our Stellara biosimilar, which utilizes an alternative cell line called SP20 and is manufactured using a perfusion manufacturing process. We believe that our perfusion platform, in which we have invested significantly, has facilitated the development of both programs. We also see that the complexity of development has potentially contributed to lower competition in the Stellara market compared to Humira and even more so for Sympony. In fact, only one other company has a known clinical study for a Sympony biosimilar candidate. This competitive landscape presents a unique opportunity for the company and our partners, including Teva in the US, Advance in Europe, and our global partners in rest of the world. We aim to be the first to market Golymumab biosimilar in global markets and expect very limited competition, if any. Our filing remain is on track for later this year and we are proud to claim that we are the only company that has developed successfully biosimilars to Humira and Stellara and have a very advanced candidate for a biosimilar to SymPony in our portfolio. We believe that is a very powerful message that both our partners and AlvoTech can use in the market. Our next portfolio product that we expect to submit this year is AVTO3, our biosimilar to both Prolia and Xgeva. We are pleased to have recently partnered with Dr. Reddy's laboratories through an agreement finalized in May of this year. The agreement covers both the US and Europe with European rights granted on a semi-exclusive basis. In June, we announced that we have expanded our partnership with Stada in Europe with AVTO3. We are thrilled to strengthen our collaboration with such a well-respected leader in that market and showcase our partnership mindset to expand more products with our existing partners and adding new ones as needed. We have passed all of the requisite studies against both originator products and look forward to providing updates in the near term. AVT23 is a biosimilar to Zolair, which we have licensed and are supporting development in conjunction with Kashif Biosciences. This program is in partnership with ADVANCE, one of our key European partners with plans for ADVANCE to market it across Europe. The proposed biosimilar continues to make significant progress with the recent completion of patient enrollment for the clinical study, making an important milestone. Filing time is near term. However, we have not commented yet on exact timing. What is also very appealing in that market, Omalizumab remains to be also a low competition market, which will benefit both Alvotec and advance at the time of launch. Our next pipeline product is a proposed biosimilar to Enfeo. The product is currently at $5.6 billion in total market size, and we believe there is significant growth opportunity for the molecule until LOE. Our program is progressing nicely, and we expect to start our patient study in September this year. One of the exciting aspects in this market is we see very few initiated studies and we believe that it could be in a pole position in the development of an end-view biosimilar. We also have some undisclosed differentiation aspects in our development. We look forward to providing updates as they occur in our program. And finally, We are also developing a biosimilar to Keytruda, which is, of course, is Merck's blockbuster oncology product, which has now surpassed Humira as the highest-grossing pharma product on record. While in an earlier stage than our previously discussed pipeline, we are making progress and expect at-scale production to occur in 2025 and are also targeting clinical study start to occur sometime next year. We continue the active discussions with multiple parties on partnership and are excited to share updates once deals become finalized. Outside of Keytruda, it is worth mentioning that we have three more development programs in early stages of development, and we also maintain a robust cell line development plan to ensure we can move forward on new products quickly and efficiently. And with that, I will turn the presentation over to Joel Morales, our Chief Financial Officer.