Q2 2026 Alvotech Earnings Call

August 20, 2026

Operator: Good day, and thank you for standing by. Welcome to the Alvotech Q2 2026 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1 1 again. 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, VP of Investor Relations and Global Communication. Please go ahead.

Speaker #1: After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star one one on your telephone; you will then hear an automated message advising your hand is raised.

Speaker #1: To withdraw your question, please press star 11 again. 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.

Speaker #1: Vice President of Investor Relations and Global Communication, please go ahead.

Speaker #2: Thank you, and welcome to our listeners. Yesterday evening, the company issued a press release announcing our financial results for the first half of 2026.

Benedikt Stefansson: Thank you, and welcome to our listeners. Yesterday evening, the company issued a press release announcing our financial results for the H1 2026. Material accompanying today's earnings call, including a supplemental earnings report, providing additional operational details and a business update, and the presentation we will be referring to on today's call were also published on our website, alvotech.com, under Financials in the Q2 section. Our press release, earnings report, presentation, and statements that we make on the call 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. Any risks and uncertainties could cause actual results to differ materially from forward-looking statements that are made.

Speaker #2: Material accompanying today's earnings call includes a supplemental earnings report providing additional operational details and a business update, as well as the presentation we will be referring to on today's call.

Speaker #2: We are also published on our website, alvotech.com, under Financials in the Q2 section. Our press release, earnings report, and presentation—as well as statements that we make on the call today—may include forward-looking statements.

Speaker #2: 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.

Speaker #2: Any risks and uncertainties could cause actual results to differ materially from forward-looking statements that are made. Presenting on today's call are Robert Wessman, founder and executive chairman; Lisa Graeber, chief executive officer; Joseph McClellan, chief operating officer; and Linda Jonsdottir, chief financial officer.

Benedikt Stefansson: Presenting on today's call are Róbert Wessman, Founder and Executive Chairman, Lisa Graver, Chief Executive Officer, Joseph McClellan, Chief Operating Officer, and Linda Jónsdóttir, Chief Financial Officer. Róbert will begin today's presentation with a summary of our regulatory, funding, and commercial highlights. Lisa will then present a commercial and operations update. Joseph will provide a pipeline and regulatory update, and Linda will conclude with a discussion of the financial results. Following the presentation, our team will be happy to take your questions. With that, I would like to turn the call over to Róbert Wessman.

Speaker #2: Robert will begin today's presentation with a summary of our regulatory, funding, and commercial highlights. Lisa will then present a commercial and operations update. Joseph will provide a pipeline and regulatory update.

Speaker #2: And Linda will conclude with a discussion of the financial results. Following the presentation, our team will be happy to take your questions. And with that, I would like to turn the call over to Robert Wessman.

Speaker #3: Hello everyone, and thank you for joining us here today. The first half has been an important period for Alvotech, as we made significant investments in our manufacturing facility and quality systems.

Róbert Wessman: Hello, everyone, and thank you for joining us here today. The H1 has been an important period for Alvotech as we made significant investments in our manufacturing facility and quality systems. These investments allowed us to resubmit our US BLAs in June. In July, the FDA formally closed the May surveillance inspection of our Reykjavik facility with a VAI classification. Our Q2 performance reflects the associated production slowdown and the preparation for our BLA resubmissions. Manufacturing returned to planned operating levels at the end of the Q2. Our order book is strong, which will support a strong Q4 as we seek to gradually rebuild sufficient safety stock for our customers. During the period, we also continued to expand our commercial portfolio, make significant progress in our R&D programs, and strengthen our financial position to support the next phase of growth.

Speaker #3: These investments allowed us to resubmit our USBLAs in June, and in July, the FDA formally closed the May surveillance inspection of our AGIC facility with a VAI classification.

Speaker #3: Our second-quarter performance reflects the associated production slowdown and the preparation for our BLA resubmissions. Manufacturing returned to planned operating levels at the end of the second quarter.

Speaker #3: Our order book is strong, which will support a strong fourth quarter as we seek to gradually rebuild sufficient safety stock for our customers. During the period, we also continue to expand our commercial portfolio, make significant progress in our R&D programs, and strengthen our financial position to support the next phase of growth.

Speaker #3: We are optimistic about our first-mover position with our NTVO biosimilar program. We were the first to submit a BLA in the US, and we have also submitted a marketing application in Europe, addressing a global market of $7 billion.

Róbert Wessman: We are optimistic about our first-mover position with our ENTYVIO biosimilar program. We were the first to submit a BLA in the US, and we have also submitted a marketing application in Europe addressing a global market of USD 7 billion. We believe these moves position us to be among the first wave of biosimilars to this important product. Alvotech now has five biosimilars contributing to product revenue, with our biosimilars to SIMPONI, EYLEA, and PROLIA/XGEVA beginning to add to our HUMIRA and STELARA biosimilar sales. We have built one of the largest biosimilar pipeline in the industry, and we are now entering an important execution phase. Our focus is on preparing for multiple anticipated launches, advancing the next wave of biosimilar candidates, and continuing to build the capabilities we need to develop, manufacture, and supply those products globally. Building a company at this scale requires long-term thinking and sustained investment.

Speaker #3: We believe these moves position us to be among the first wave of biosimilars for this important product. Alvotech now has five biosimilars contributing to product revenue, with our biosimilars to Sympony, Eylea, and Prolia/Xgeva beginning to add to our Humira and Stelara biosimilar sales.

Speaker #3: We have built one of the largest biosimilar pipelines in the industry, and we are now entering an important execution phase. Our focus is on preparing for multiple anticipated launches, advancing the next wave of biosimilar candidates, and continuing to build the capabilities we need to develop, manufacture, and supply those products globally.

Speaker #3: Building a company at this scale requires long-term thinking and sustained investment. Capital is the fuel that enables us to execute. The equity financing completed in June generated approximately $165 million in gross proceeds.

Róbert Wessman: Capital is the fuel that enables us to execute. The equity financing completed in June generated approximately USD 165 million in gross proceeds. We were very pleased with the strong demand for the offering and, more importantly, with the composition of the demand. Alongside continued support from our existing shareholders, we welcomed 20 new specialists in healthcare from across the US, Europe, and the Nordics. The diversification of the shareholder base is important because it brings investors with a deep understanding of the sector and our opportunity. Linda will take you through the financing in a little bit more details. We continued also to evolve our commercial model. Our primary route to enter global market is through our network of commercial partners in a business-to-business model.

Speaker #3: We were very pleased with the strong demand for the offering, and, more importantly, with the composition of the demand. Alongside continued support from our existing shareholders, we welcomed 20 new specialists in healthcare from across the US, Europe, and the Nordics.

Speaker #3: The diversification of the shareholder base is important because it brings investors with a deep understanding of the sector and our opportunity. Linda will take you through the financing in a little bit more detail.

Speaker #3: We continued also to evolve our commercial model. Our primary route to enter the global market is through our network of commercial partners, in a business-to-business model.

Speaker #3: At the same time, as we look ahead, we see opportunities for Alvotech to participate more directly in the U.S. markets, including by commercializing selected pipeline products ourselves.

Róbert Wessman: At the same time, as we look ahead, we see opportunities for Alvotech to participate more directly in the US markets, including by commercializing selected pipeline products ourselves. I have always believed that strategy itself is only part of building a successful company. Ultimately, it comes down to execution. You need the right people, the right capabilities, the right partners, and the financial resources to deliver. I believe we have continued to strengthen each of those elements during the H1. And with that, I will hand it over to Lisa.

Speaker #3: I have always believed that strategy itself is only part of building a successful company. Ultimately, it comes down to execution. You need the right people, the right capabilities, the right partners, and the financial resources to deliver.

Speaker #3: I believe we have continued to strengthen each of those elements during the first half. And with that, I will hand it over to Lisa.

Speaker #4: Thank you, Robert. I want to start by putting our first-half performance in context. As we have previously discussed, during the first half we made significant improvements to our manufacturing facility and quality systems in Reykjavík.

Lisa Graver: Thank you, Róbert. I want to start by putting our H1 performance in context. As we have previously discussed, during the H1, we made significant improvements to our manufacturing facility and quality systems in Reykjavik. These activities form the foundation of our response to FDA's inspectional observations following the July 2025 pre-license inspection and enabled us to resubmit our applications for AVT05 and AVT06. The resubmissions are a clear inflection point for the company as they pave the way for FDA approvals in the Q4 2026. In particular, it positions us to be the first or amongst the first biosimilars to be approved for SIMPONI and SIMPONI ARIA in the US. Joseph will provide further updates on the improvement program at our Reykjavik site and the favorable outcome of the recent GMP surveillance inspection by FDA.

Speaker #4: These activities form the foundation of our response to the FDA's inspectional observations following the July 2025 pre-license inspection, and enabled us to resubmit our applications for AVT05 and AVT06.

Speaker #4: The resubmissions are a clear inflection point for the company, as they paved the way for FDA approvals in the fourth quarter of 2026. In particular, it positions us to be the first, or among the first, biosimilars to be approved for Symphony and Symphony ARIA in the US.

Speaker #4: Joe will provide further updates on the improvement program at our Reykjavík site, and the favorable outcome of the recent GMP surveillance inspection by the FDA.

Speaker #4: While the improvement program was critical to ensuring a robust response to the FDA, those activities affected manufacturing output and, therefore, product availability during the period.

Lisa Graver: While the improvement program was critical to ensuring a robust response to FDA, those activities affected manufacturing output and therefore product availability during the period. Manufacturing returned to planned operating levels at the end of Q2, and our focus is now on building supply in accordance with commercial requirements as we move through the H2. At the same time, the underlying commercial demand for our portfolio has remained strong. That distinction between market demand and our reported product revenue is particularly important this quarter. As a B2B company, we manufacture and supply product to our commercial partners. Our reported product revenue, therefore, reflects not only underlying demand, but the timing of partner orders, inventory movements, and our own product availability.

Speaker #4: Manufacturing returned to planned operating levels at the end of the second quarter, and our focus is now on building supply in accordance with commercial requirements as we move through the second half.

Speaker #4: At the same time, the underlying commercial demand for our portfolio has remained strong. That distinction between market demand and our reported product revenue is particularly important this quarter.

Speaker #4: As a B2B company, we manufacture and supply product to our commercial partners. Our reported product revenue, therefore, reflects not only underlying demand, but also the timing of partner orders, inventory movements, and our own product availability.

Speaker #4: As we've explained previously, that can create variability between reporting periods. This was particularly evident during the first half of 2026 and the second half of last year, due to the slowdown in manufacturing necessitated by the facility improvement activities.

Lisa Graver: As we've explained previously, that can create variability between reporting periods, and it was particularly evident during the H1 of 2026 and the H2 of last year due to the slowdown in manufacturing necessitated by the facility improvement activities. Turning to our financial highlights, total revenue for the H1 was USD 212 million, compared with USD 306 million in the H1 of 2025. Adjusted EBITDA was USD 46 million, compared with USD 54 million last year, and gross margin was 54%, broadly consistent with 55% in the prior year period. Both revenues and EBITDA are in line with our expectations. We ended June with USD 143 million of cash, following the successful equity financing completed during the quarter.

Speaker #4: Turning to our financial highlights, total revenue for the first half was $212 million, compared with $306 million in the first half of 2025. Adjusted EBITDA was $46 million, compared with $54 million last year.

Speaker #4: Gross margin was 54%, broadly consistent with 55% in the prior year period. Both revenues and EBITDA are in line with our expectations. We ended June with $143 million of cash, following the successful equity financing completed during the quarter.

Speaker #4: Based on our current expectations for product supply, as well as anticipated contributions from milestone revenue in the second quarter, we are reaffirming our 2026 guidance of $650 to $700 million in total revenue, and $180 to $220 million in adjusted EBITDA.

Lisa Graver: Based on our current expectations for product supply, as well as anticipated contributions from milestone revenue in the Q2, we are reaffirming our 2026 guidance of USD 650 to 700 million in total revenue and USD 180 to 220 million in adjusted EBITDA. Linda will take you through the financial performance and the key drivers in more detail later in the presentation. As Robert outlined, the H1 saw significant operational progress across the business. Rather than repeat those milestones, I want to focus on what they mean for the next phase of execution, particularly the performance of our commercial portfolio and our preparations for the next wave of launches. Let me start with the commercial portfolio and AVT02. The US adalimumab market continues to demonstrate strong biosimilar conversion. Biosimilars now account for more than 60% of the market, compared with approximately 55% when we last reported.

Speaker #4: Linda will take you through the financial performance and the key drivers in more detail later in the presentation. As Robert outlined, the first half saw significant operational progress across the business.

Speaker #4: Rather than repeat those milestones, I want to focus on what they mean for the next phase of execution, particularly the performance of our commercial portfolio and our preparations for the next wave of launches.

Speaker #4: Let me start with the commercial portfolio and AVT02. The U.S. adalimumab market continues to demonstrate strong biosimilar conversion. Biosimilars now account for more than 60% of the market, compared with approximately 55% when we last reported.

Speaker #4: Synlandie continues to hold the number two biosimilar position in the US. That is important because, while our first half supply constraints affected the volume we could deliver to our partner, the underlying demand picture remains strong.

Lisa Graver: SIMLANDI continues to hold the number 2 biosimilar position in the US. That is important because while our H1 supply constraints affected the volume we could deliver to our partner, the underlying demand picture remained strong. Europe also provides an interesting indication of the longevity of these franchises. Hukyndra was first launched four years ago, yet we continue to see sustained demand across key European markets. Recent partner performance reinforces our view that successful biosimilars for chronic conditions do not necessarily reach a short-term peak and then decline. They can remain valuable commercial assets for many years. That is one of the reasons we think it is important to look beyond individual quarterly supply and focus on the development of these franchises over time. We are seeing a similar market transition with AVT04.

Speaker #4: Europe also provides an interesting indication of the longevity of these franchises. QQindra was first launched four years ago, yet we continue to see sustained demand across key European markets.

Speaker #4: Recent partner performance reinforces our view that successful biosimilars for chronic conditions do not necessarily reach a short-term peak and then decline. They can remain valuable commercial assets for many years.

Speaker #4: That is one of the reasons we think it is important to look beyond individual quarterly supply and focus on the development of these franchises over time.

Speaker #4: We are seeing a similar market transition with AVT04. Biosimilar penetration of the US ustekinumab market has developed considerably faster than we saw with adalimumab, and is now around 60%.

Lisa Graver: Biosimilar penetration of the US ustekinumab market has developed considerably faster than we saw with adalimumab and is now around 60%. SELARSDI continues to participate in an expanding market. Our strategy here remains disciplined. We are focused on building sustainable business and attractive economics rather than merely pursuing volume. In Europe, biosimilars have also taken share rapidly from the originator, and Uzpruvo remains well-positioned in an increasingly established biosimilar market. Again, the important point is that the underlying market is developing as we anticipated. The next part of the commercial story is the expansion beyond AVT02 and AVT04. AVT05 and AVT06 are now launched across more than 10 European markets, including the major markets of Germany, France, the UK, Spain, and Italy. For AVT05, we have seen encouraging early momentum, particularly in Germany and Spain.

Speaker #4: Solaresty continues to participate in an expanding market. Our strategy here remains disciplined. We are focused on building a sustainable business and attractive economics, rather than merely pursuing volume.

Speaker #4: In Europe, biosimilars have also taken share rapidly from the originator, and UzProvo remains well-positioned in an increasingly established biosimilar market. Again, the important point is that the underlying market is developing as we anticipate it.

Speaker #4: The next part of the commercial story is the expansion beyond AVT02 and AVT04. AVT05 and AVT06 are now launched across more than 10 European markets.

Speaker #4: Including the major markets of Germany, France, the UK, Spain, and Italy. For AVT05, we have seen encouraging early momentum, particularly in Germany and Spain.

Speaker #4: The product was also launched in Japan in July, where it is currently the only approved golimumab biosimilar. In the US, we are expecting regulatory approval in the fourth quarter of this year, and we anticipate being one of only two biosimilars on the market in the near term.

Lisa Graver: The product was also launched in Japan in July, where it is currently the only approved golimumab biosimilar. In the US, we are expecting regulatory approval in Q4 of this year, and we anticipate being one of only two biosimilars on the market in the near term. AVT06 has similarly established a broad European footprint. It was launched in Japan earlier this year and has seen strong early uptake. We also have a clear pathway to US market entry under the settlement and licensing agreement announced in January, subject of course to regulatory approval. That agreement provides for US market entry from Q4 2026. Taken together, these products broaden our commercial base. We entered 2026 with product revenue principally driven by AVT02 and AVT04.

Speaker #4: AVT06 has similarly established a broad European footprint. It was launched in Japan earlier this year and has seen strong early uptake. We also have a clear pathway to US market entry under the settlement and licensing agreement announced in January—subject, of course, to regulatory approval.

Speaker #4: That agreement provides for US market entry from the fourth quarter of 2026. Taken together, these products broaden our commercial base. We entered 2026 with product revenue principally driven by AVT02 and AVT04; we now have five biosimilars contributing to product revenue, with three of those franchises still at an early stage of their commercial development.

Lisa Graver: We now have five biosimilars contributing to product revenue, with three of those franchises still at an early stage of their commercial development. That gives us a much more diversified platform for future growth. We now enter the H2 with manufacturing back at planned operating levels, supply levels improving, and a broader commercial portfolio. I will now hand over to Joe to discuss our regulatory progress and pipeline.

Speaker #4: That gives us a much more diversified platform for future growth. So, we now enter the second half with manufacturing back at planned operating levels, supply levels improving, and a broader commercial portfolio.

Speaker #4: I will now hand over to Joe to discuss our regulatory progress and pipeline.

Speaker #2: Thank you, Lisa. I will briefly cover the following topics today: the status of our ongoing facility and quality improvements, U.S. regulatory updates—including on our complete response resubmissions—and updates on our biosimilar development pipeline.

Joseph McClellan: Thank you, Lisa. I will briefly cover the following topics today: The status of our ongoing facility and quality improvements, US regulatory updates, including on our complete response resubmissions, and updates on our biosimilar development pipeline. As we have discussed on previous calls, following the US FDA's observations in mid-2025, we initiated a comprehensive improvement program across our Reykjavik facility. By the end of 2025, we had implemented the majority of our committed and necessary corrective actions. Since then, our focus has been on demonstrating that those improvements are effective and sustainable, implementing continuous improvement opportunities, and embedding them in our routine manufacturing and quality operations. These extensive efforts form the basis of our response to the FDA's post-action application letters and enabled the resubmission to our four Biologics License Applications for the proposed biosimilars to SIMPONI ARIA, EYLEA, and the dual products Prolia/Xgeva in June of this year.

Speaker #2: As we have discussed on previous calls, following the US FDA's observations in mid-2025, we initiated a comprehensive improvement program across our Reykjavik facility. By the end of 2025, we had implemented the majority of our committed and necessary corrective actions.

Speaker #2: Since then, our focus has been on demonstrating that those improvements are effective and sustainable, implementing continuous improvement opportunities, and embedding them in our routine manufacturing and quality operations.

Speaker #2: These extensive efforts form the basis of our response to the FDA's post-action application letters and enabled the resubmission of our four Biologics License Applications for the proposed biosimilars to Symphony, Symphony Aria, Eylea, and the dual products Prolia/Xgeva, in June of this year.

Speaker #2: In their acknowledgment letters for each of the resubmissions, as complete responses to the previous action letters, the FDA confirmed review completion goal dates in alignment with the standard six-month process.

Joseph McClellan: In their acknowledgment letters for each of the resubmissions as complete responses to the previous action letters, the FDA confirmed review completion goal dates in alignment with the standard six-month process. Separately, the FDA completed a routine GMP surveillance inspection of our Reykjavik facility in May 2026. In July, the agency formally closed that inspection with a voluntary action-indicated classification. Our Reykjavik facility remains an FDA-approved manufacturing site, and we continue to manufacture our on-market products both for the US and rest-of-world markets. We are confident that the actions we have taken to address observations from our recent FDA inspections have effectively addressed all observations. With the resubmissions now completed, we continue to work with the FDA as those applications progress through review to enable our important medicines to be available in the US.

Speaker #2: Separately, the FDA completed a routine GMP surveillance inspection of our Reykjavik facility in May 2026. In July, the agency formally closed that inspection with a "voluntary action indicated" classification.

Speaker #2: Our Reykjavik facility remains an FDA-approved manufacturing site, and we continue to manufacture our on-market products both for the U.S. and rest-of-world markets.

Speaker #2: We are confident that the actions we have taken to address observations from our recent FDA inspections have effectively addressed all observations. With the resubmissions now completed, we continue to work with the FDA as those applications progress through review, to enable our important medicines to be available in the US.

Speaker #2: Turning to the development pipeline, Alvotech continues to build one of the largest internally developed biosimilar pipelines in the industry, with more than 30 candidates currently in development.

Joseph McClellan: Turning to the development pipeline, Alvotech continues to build one of the largest internally developed biosimilar pipelines in the industry, with more than 30 candidates currently in development. When selecting new programs, we prioritize biologics with significant market opportunity, durable mechanisms of action, high scientific barriers where Alvotech can succeed, and opportunities for differentiation through our integrated development and manufacturing platform. These attractive molecules make up our early phase and preclinical pipeline, supported by ongoing process, product, and analytical development, manufacturing, clinical, regulatory, and intellectual property workstreams to enable future approvals and commercialization. This portfolio breadth is important because biosimilar development is inherently a portfolio business. Individual programs have different technical, regulatory, competitive, and IP profiles. Our broader pipeline gives us multiple opportunities to create value over time.

Speaker #2: When selecting new programs, we prioritize biologics with significant market opportunity, durable mechanisms of action, high scientific barriers where Alvotech can succeed, and opportunities for differentiation through our integrated development and manufacturing platform.

Speaker #2: These attractive molecules make up our early-phase and preclinical pipeline, supported by ongoing process, product, and analytical development, manufacturing, clinical, regulatory, and intellectual property workstreams to enable future approvals and commercialization.

Speaker #2: This portfolio breadth is important because biosimilar development is inherently a portfolio business. Individual programs have different technical, regulatory, competitive, and IP profiles. Our broader pipeline gives us multiple opportunities to create value over time.

Speaker #2: Beyond the ongoing launches, as previously discussed, our next wave of products is expected to receive approvals over the 2027 to 2029 time horizon. These include our proposed biosimilar to Keytruda, which is co-developed with Dr. Reddy's, and for which we have commenced a randomized, double-blind, pharmacokinetic similarity study to compare it with the reference product in participants with melanoma.

Joseph McClellan: Beyond the ongoing launches, as previously discussed, our next wave of products is expected to receive approvals over the 2027 to 2029 time horizon. These include our proposed biosimilar to Keytruda, which is co-developed with Dr. Reddy's, and where we have commenced a randomized, double-blind pharmacokinetic similarity study to compare it with the reference product in participants with melanoma. Also, in this near-term horizon of approvals are our proposed biosimilars to ENTYVIO and EYLEA HD. Our development of a proposed biosimilar to ENTYVIO, including both the intravenous presentation, which we denote as AVT16, and the high-concentration subcutaneous presentation, which we denote as AVT80, is a good example of the capabilities we have built. ENTYVIO is an important therapy for inflammatory bowel disease and represents a multi-billion dollar opportunity in the immunology market.

Speaker #2: Also, in this near-term horizon of approvals, are our proposed biosimilars to Entyvio and Eylea high-dose. Our development of a proposed biosimilar to Entyvio, including both the intravenous presentation, which we denote as AVT16, and the high-concentration subcutaneous presentation, which we denote as AVT80, is a good example of the capabilities we have built.

Speaker #2: Intivio is an important therapy for inflammatory bowel disease and represents a multi-billion dollar opportunity in the immunology market. We are pleased that the European marketing authorization application for both AVT16 and AVT80 has been validated and is progressing through review.

Joseph McClellan: We are pleased the European marketing authorization application for both AVT16 and AVT80 has been validated and progressing through review. The FDA has accepted a Biologics License Application for AVT16, as we have previously announced. We are looking forward to communicating positive news on a US Biologics License Application for AVT80 soon. We expect decisions on these applications in 2027. The significance of the development of our proposed biosimilar to ENTYVIO goes beyond one molecule. It demonstrates Alvotech's ability to develop multiple presentations around a major biological franchise and to advance them across different regulatory pathways with speed. Now, turning to AVT29. As we have discussed previously, the high-dose version of EYLEA supports extended dosing intervals compared with the original presentation, and we are seeing it become the leading EYLEA presentation and an increasingly important part of the global ophthalmology market.

Speaker #2: The FDA has accepted a Biologics License Application for AVT16, as we have previously announced. We are looking forward to communicating positive news on a U.S. Biologics License Application for AVT80 soon.

Speaker #2: We expect decisions on these applications in 2027. The significance of the development of our proposed biosimilar to Entyvio goes beyond one molecule. It demonstrates Alvotech's ability to develop multiple presentations around a major biological franchise, and to advance them across different regulatory pathways with speed.

Speaker #2: Now, turning to AVT29—as we have discussed previously, the high-dose version of Eylea supports extended dosing intervals compared with the original presentation. We are seeing it become the leading Eylea presentation and an increasingly important part of the global ophthalmology market.

Speaker #2: We anticipated the shift when we selected AVT29 for development. Together with AVT06, our biosimilar to Eylea low-dose, we have the opportunity to participate across both the established and high-dose segment of what remains one of the largest markets in ophthalmology.

Joseph McClellan: We anticipated this shift when we selected AVT29 for development. Together with AVT06, our biosimilar to EYLEA low dose, we have the opportunity to participate across both the established and high-dose segments of what remains one of the largest markets in ophthalmology. We remain on track for our first regulatory submission this year. Further, our ALVO-I HD clinical study, which is a randomized clinical study to evaluate the efficacy and safety of AVT29 compared with EYLEA HD in participants with diabetic macular edema, was the first to be initiated globally and is progressing in alignment with expectations to enable a US regulatory submission in 2028. Based on these timelines, we believe AVT29 has the potential to be among the first wave of EYLEA HD biosimilars in major markets. With that, I hand over to Linda for the financial review.

Speaker #2: We remain on track for our first regulatory submission this year. Further, our AlvoIHD clinical study, which is a randomized clinical study to evaluate the efficacy and safety of AVT29 compared with AileaHD in participants with diabetic macular edema, was the first to be initiated globally, and is progressing in alignment with expectations to enable a US regulatory submission in 2028.

Speaker #2: Based on these timelines, we believe AVT29 has the potential to be among the first wave of AileaHD biosimilars in major markets. With that, I hand over to Linda for the financial review.

Speaker #3: I will now take you briefly through some highlights of our financials for the second quarter and the first half of 2026. Unless otherwise stated, the figures I will go through are adjusted numbers. Reconciliations to the corresponding IFRS measures are included in our earnings material, which has been published under Financials in the Investor section of our website, alvotech.com.

Linda Jónsdóttir: I will now take you briefly through some highlights of our financials for the Q2 and the H1 of 2026. Unless otherwise stated, the figures I will go through are adjusted numbers. Reconciliations to the corresponding IFRS measures are included in our earnings material, which have been published under Financials in the Investor section of our website, alvotech.com. During the H1 of the year, facility improvements led to manufacturing slowdown and temporarily constrained supply. But as mentioned before, those slowdowns also enabled a successful close of the FDA GMP inspection during this period and our resubmission of BLAs to the FDA. These improvements provide a good foundation for growing performance heading into the H2 of the year, and as we have noted earlier, we expect the Q4 in particular to be the strongest quarter of the year.

Speaker #3: During the first half of the year, facility improvements led to a manufacturing slowdown and temporarily constrained supply. But as mentioned before, those slowdowns also enabled a successful close of the FDA GMP inspection during this period, and our resubmission of BLAs to the FDA.

Speaker #3: These improvements provide a good foundation for growing performance heading into the second half of the year, and as we have noted earlier, we expect the fourth quarter in particular to be the strongest quarter of the year.

Speaker #3: I'll begin with the second quarter highlights before covering the first six months as a whole. The second quarter was in line with expectations, and we finalized a successful equity issue, delivering a strong cash position at the end of June.

Linda Jónsdóttir: I'll begin with the Q2 highlights before covering the first 6 months as a whole. The Q2 was in line with expectations, and we finalized a successful equity issue, delivering strong cash position at the end of June. Total revenues were down 39% compared to the same period last year, but up level with the Q1 of the year at USD 106 million. Gross margin in Q2 was 51%, reflecting lower product and milestone revenues compared to previous periods. Our product margin in Q2 was down 17 basis points compared to the same quarter last year at 6%, impacted by the product mix and facility improvements, which were concluded at the end of the quarter.

Speaker #3: Total revenues were down 39% compared to the same period last year, but were level with the first quarter of the year at $106 million.

Speaker #3: Gross margin in Q2 was 51%, reflecting lower product and milestone revenues compared to previous periods. Our product margin in Q2 was down 17 basis points compared to the same quarter last year, at 6%, impacted by the product mix and facility improvements, which were concluded at the end of the quarter.

Speaker #3: Adjusted EBITDA was $23 million in the quarter, down 32% year-on-year, due to lower product and milestone revenues compared to the same quarter last year.

Linda Jónsdóttir: Adjusted EBITDA was USD 23 million in the quarter, down 32% year-on-year due to lower product and milestone revenues compared to the same quarter last year, which saw the launch of our biosimilar to Stelara in the US. Turning to the financial highlights for the H1 of 2026. Total revenues were USD 212 million, representing a 31% decline compared to the same period last year. Gross margin was 54%, broadly in line with the same period last year, with licensing revenues contributing half of total revenues in the current period. Product margin was 8%. Margins continued to be impacted until end of Q2 by reduced manufacturing throughput associated with facility improvements at the Reykjavik site. We expect that Alvotech will be positioned to enter 2027 with a stronger margin profile. Adjusted EBITDA was USD 47 million, representing a margin of 22%.

Speaker #3: which saw the launch of our biosimilar to Stelara in the US. Turning to the financial highlights for the first half of 2026, total revenues were $212 million, representing a 31% decline compared to the same period last year.

Speaker #3: Gross margin was 54%, broadly in line with the same period last year, with licensing revenues contributing half of total revenues in the current period.

Speaker #3: Product margin was 8%. Margins continued to be impacted until the end of Q2 by reduced manufacturing throughput associated with facility improvements at our Reykjavik site.

Speaker #3: We expect that Alvotech will be positioned to enter 2027 with a stronger margin profile. Adjusted EBITDA was $47 million, representing a margin of 22%.

Speaker #3: Adjusted EBITDA in the same period last year was higher at $54 million, with a 4-basis-point lower margin of 18%. As noted in our last earnings call, we are expecting Q4 to be the strongest quarter of the year.

Linda Jónsdóttir: Adjusted EBITDA in the same period last year was higher at EUR 54 million, with a 4 basis point lower margin of 18%. As noted in our last earnings call, we are expecting Q4 to be the strongest quarter of the year. We will start to see Q3 regaining momentum on the product revenue side with a strong step up expected in Q4, both for product revenues and milestones. Further on the revenues in H1. Half of the revenues come from product revenues, which were at EUR 106 million. We now have five end market products contributing to product revenues. In H1, launches of these three new products expanded across Europe, the UK, and Japan.

Speaker #3: We will start to see Q3 regaining momentum on the product revenue side, with a strong step-up expected in Q4, both for product revenues and milestones.

Speaker #3: Further on the revenues in the first half of the year, half of the revenues come from product revenues, which were at $106 million. We now have five in-market products contributing to product revenues.

Speaker #3: In the first half of the year, launches of these three new products expanded across Europe, the UK, and Japan. As we have noted previously, as a B2B company, our reported product revenue reflects not only underlying market demand but also the timing of partner orders, inventory movements, and our own product availability.

Linda Jónsdóttir: As we have noted previously, as a B2B company, our reported product revenue reflects not only underlying market demand, but also the timing of partner orders, inventory movements, and our own product availability. During H1, manufacturing output was affected by the improvement activities at the Reykjavik site, which constrained our product supply. Manufacturing returned to planned operating levels at the end of Q2. Our focus is now on rebuilding sufficient supply for our clients and meeting commercial requirements as we move through the year. Importantly, underlying market demand for our products remains strong. As supply normalizes, we expect that demand to be reflected in product revenue in subsequent periods. Licensing revenues in H1 were EUR 106 million.

Speaker #3: During the first half, manufacturing output was affected by the improvement activities at our Reykjavik site, which constrained our product supply. Manufacturing returned to planned operating levels at the end of the second quarter. Our focus is now on rebuilding sufficient supply for our clients and meeting commercial requirements as we move through the year.

Speaker #3: Importantly, underlying market demand for our products remains strong. As supply normalizes, we expect that demand to be reflected in product revenue in subsequent periods.

Speaker #3: Licensing revenues in the first half were $106 million. As we have also noted earlier, milestone revenue recognition will be inherently lumpy, as it is driven by progress in R&D, timing of marketing authorization applications, and other contractual milestones achieved.

Linda Jónsdóttir: As we have also noted earlier, milestone revenue recognition will be inherently lumpy as it is driven by progress in R&D, timing of marketing authorization applications, and other contractual milestones achieved. Turning to cash flow. Cash on hand at the end of the period was EUR 143 million, reflecting in part our equity raise completed in June. Cash from operations was EUR 17 million during the quarter, reflecting operations and changes in working capital. But as you can see from the cash flow bridge, all the key drivers impacting cash flow in the quarter were net interest payments of EUR 37 million per quarter following the transition from PIK to cash interest in mid-2025. CapEx at EUR 28 million in the quarter, primarily consisting of the cost of facility improvements, which have now been concluded. Investment in intangibles of EUR 17 million, reflecting continued investment in the advancement of our biosimilar pipeline.

Speaker #3: Turning to cash flow, cash on hand at the end of the period was $143 million, reflecting in part our equity raise completed in June.

Speaker #3: Cash from operations was $17 million during the quarter, reflecting operations and changes in working capital. But as you can see from the cash flow bridge, other key drivers impacting cash flow in the quarter were net interest payments of $37 million per quarter, following the transition from PIK to cash interest in mid-’25; Capex at $28 million in the quarter, primarily consisting of the cost of facility improvements—which have now been concluded; and investment in intangibles of $17 million, reflecting continued investment in the advancement of our biosimilar pipeline.

Speaker #3: Turning to the financing completed during the quarter: the equity offering completed in June generated approximately $165 million in gross proceeds. The transaction was initially launched at $125 million, increased to $152 million at pricing, and the full exercise of the overallotment option increased the total to approximately $165 million.

Linda Jónsdóttir: Turning to the financing completed during the quarter. The equity offering completed in June generated approximately $165 million in gross proceeds. The transaction was initially launched at $125 million, increased to $152 million at pricing, and the full exercise of the overallotment option increased the total to approximately $165 million. In addition, we secured an additional term loan facility of up to $75 million with our existing lenders, which we have drawn on in Q3 and is therefore not included in our Q2 cash position. Together, this represents approximately $240 million of new equity and debt financing, enhancing our financial flexibility. This capital supports continued investment in our pipeline, preparation for additional product launches, global commercialization, and our manufacturing and supply requirements. These investments are focused on supporting the execution of our strategic priorities and the next phase of Alvotech's growth.

Speaker #3: In addition, we secured an additional term loan facility of up to $75 million with our existing lenders, which we've drawn on in Q3 and is therefore not included in our Q2 cash position.

Speaker #3: Together, this represents approximately $240 million of new equity and debt financing, enhancing our financial flexibility. This capital supports continued investment in our pipeline, preparation for additional product launches, global commercialization, and our manufacturing and supply requirements.

Speaker #3: These investments are focused on supporting the execution of our strategic priorities and the next phase of Alvotech's growth. Looking at the balance sheet, I will start by briefly summarizing key items on the asset side.

Linda Jónsdóttir: Looking at the balance sheet, I will start with briefly summarizing key items on the asset side. From end 2025, non-current assets were up by $129 million, mainly driven by an increase in intangible assets and higher contract assets due to the timing of revenue recognition. Total current assets decreased by $29 million, reflecting collections of trade receivables, partially offset by increase in inventories and other current assets. Next, a few notes on key movements across equity and liabilities. Total equity improved by $93 million and was strengthened by the June 2026 equity financing. Non-current liabilities decreased by $20 million, mainly driven by a $15 million reduction in derivative financial liabilities due to fair value changes, and current liabilities increased by $27 million, including the recognition of a commercial provision, while contract liabilities declined as previously deferred revenue was recognized. Turning to the financial outlook for the year.

Speaker #3: At the end of Q2, non-current assets were up by $129 million, mainly driven by an increase in intangible assets and higher contract assets due to the timing of revenue recognition.

Speaker #3: Total current assets decreased by $29 million, reflecting collections of trade receivables, partly offset by an increase in inventories and other current assets. Next, a few notes on key movements across equity and liabilities.

Speaker #3: Total equity improved by $93 million and was strengthened by the June 26 equity financing. Non-current liabilities decreased by $20 million, mainly driven by a $15 million reduction in derivative financial liabilities due to fair value changes. Current liabilities increased by $27 million, including the recognition of a commercial provision, while contract liabilities declined as previously deferred revenue was recognized.

Speaker #3: Turning to the financial outlook for the year, we target revenues in the range of $650 to $700 million, representing continued double-digit annual growth from last year.

Linda Jónsdóttir: We target revenues in the range of $650 to $700 million, representing continued double-digit annual growth from last year. Adjusted EBITDA is targeted to be in the range of $180 to $220 million. As we look ahead to the H2 of the year and into 2027, we expect to see the benefit of increased manufacturing output after the completion of facility improvements and major enhancements that have been implemented since the middle of last year. We therefore expect to be able to deliver strong year-on-year growth in 2026 with an expanded product portfolio and development milestones from our expanding pipeline. As we have noted earlier, we expect to deliver healthy de-leveraging of our balance sheet in 2027, presenting further opportunities to optimize our capital structure. With that, I will hand the call back to Lisa.

Speaker #3: Adjusted EBITDA is targeted to be in the range of $180 to $220 million. As we look ahead to the second half of the year and into 2027, we expect to see the benefit of increased manufacturing output after the completion of facility improvements and major enhancements that have been implemented since the middle of last year.

Speaker #3: We therefore expect to be able to deliver strong, year-on-year growth in 2026 with an expanded product portfolio and development milestones from our expanding pipeline.

Speaker #3: As we have noted earlier, we expect to deliver healthy deleveraging of our balance sheet in '27, presenting further opportunities to optimize our capital structure.

Speaker #3: With that, I will hand the call back to Lisa.

Speaker #1: Thank you, Linda. In summary, we believe the first half of 2026 demonstrates the progress Alvotech is making across each of the areas that are critical for the next phase of growth.

Lisa Graver: Thank you, Linda. In summary, we believe the H1 of 2026 demonstrates the progress Alvotech is making across each of the areas that are critical for the next phase of growth. Our commercial portfolio is expanding, with five products now contributing to revenue and a growing presence across markets. We have important regulatory catalysts ahead and are preparing for the next wave of product launches. We continue to strengthen and scale our manufacturing platform while investing selectively in a pipeline we believe can create significant future value. With that, we will open the call for questions.

Speaker #1: Our commercial portfolio is expanding, with five products now contributing to revenue and a growing presence across markets. We have important regulatory catalysts ahead and are preparing for the next wave of product launches.

Speaker #1: We continue to strengthen and scale our manufacturing platform while investing selectively in a pipeline we believe can create significant future value. With that, we'll open the call for questions.

Speaker #2: Thank you. We will now begin the question-and-answer session. If you wish to ask a question, you will need to press star one one on your telephone and wait for your name to be announced.

Operator: Thank you. We will now begin the question and answer session. If you wish to ask a question, you will need to press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. We will take our first question. Your first question comes from the line of Christopher Uhde from SEB. Please go ahead. Your line is open.

Speaker #2: To withdraw your question, please press star 11 again. We will take our first question. Your first question comes from the line of Christopher Uda from SEB.

Speaker #2: Please go ahead. Your line is open.

Speaker #4: Hi there. Thanks for taking my questions. Christopher Udi from SEB here. My first question is on the Biofera news. You guys haven't mentioned it.

Christopher Uhde: Hi there. Thanks for taking my questions. Christopher Uhde from SEB here. My first question is on the Bio-Thera news. You guys haven't mentioned it. I have no doubt you saw it. What can you say about how you're viewing the impact on your SIMPONI biosimilar and how you expect it to evolve going forward? Are there any tenders perhaps that might have been won that reopen or need to be reevaluated that could be a positive for you in the short term, and obviously then the more medium and long-term picture? Thank you. That's the first one. Then the second one was obviously it's exciting to hear about your US commercialization plans. Which disclosed assets are you not yet partnered for the US? Should we update our models for those yet, or should we wait and see? Thank you very much.

Speaker #4: I have no doubt you saw it. What can you say about how, you know, how you're viewing the impact on Symphony, your Symphony biosimilar, and how you expect it to evolve going forward?

Speaker #4: And are there any tenders, perhaps, that might have been won that could reopen or need to be re-evaluated, that could be a positive for you in the short term?

Speaker #4: And obviously, then, the more medium- and long-term picture. Thank you. That is the first one. And then the second one was, obviously, it's exciting to hear about your US commercialization plans.

Speaker #4: Which disclosed assets are you not yet partnered for in the US? And should we update our models for those yet, or should we wait and see?

Speaker #4: Thank you very much.

Speaker #5: Hi, Christopher. Thanks for the question. So on biosimilar, certainly we are looking, and our partner in Europe, Advance, is doing everything it can to take advantage of the fact that we are truly first in.

Lisa Graver: Hi, Christopher. Thanks for the question. On Bio-Thera, certainly, we are looking, and our partner in Europe, Advanz Pharma, is doing everything it can to take advantage of the fact that we are truly first in the market. From a supply perspective, we have been building in anticipation, clearly, for the launch that happened late last year. We are well-positioned with supply through the rest of this year and certainly are looking to be so as we look to 2027 and even beyond. I think our partner has done well, certainly expanding market share. I think sitting slightly north of 15% at this point and growing. What I would say is we are fully capable on both our end as well as our partner's end to take advantage, and make sure that we access the market in the fullest possible way.

Speaker #5: From a supply perspective, we have been building in anticipation, clearly, for this—the launch that happened late last year. We are well positioned with supply through the rest of this year.

Speaker #5: And certainly, we are looking to be so as we look to 2027 and even beyond. I think our partner has done well, certainly expanding market share.

Speaker #5: I think sitting, you know, slightly north of 15% at this point and growing. So, what I would say is we are fully capable, on both our end as well as our partner's end, to take advantage.

Speaker #5: And make sure that we access the market in the fullest possible way. I think from a future-looking perspective, certainly we don't know, sitting here today, the long-range opportunity.

Joel Morales: I think from a future-looking perspective, certainly we don't know sitting here today, the long-range opportunity, but we're preparing for it. I think we're optimistic that this will continue to drive our European growth story, in addition to the other molecules we have in the space today. But we're quite excited about what we're seeing with AVT05 and golimumab. On your second question, there are a few assets that remain, especially as we look at our pipeline, which is quite robust, as you know. Several are in various phases of early and mid-stage development that we are still in active licensing discussions around. What I would say, Christopher, is as we look and secure those future arrangements, we will certainly update the market. I think we'll have some news as we go throughout Q3 and Q4 on that front.

Lisa Graver: I think from a future-looking perspective, certainly we don't know sitting here today, the long-range opportunity, but we're preparing for it. I think we're optimistic that this will continue to drive our European growth story, in addition to the other molecules we have in the space today. But we're quite excited about what we're seeing with AVT05 and golimumab. On your second question, there are a few assets that remain, especially as we look at our pipeline, which is quite robust, as you know. Several are in various phases of early and mid-stage development that we are still in active licensing discussions around. What I would say, Christopher, is as we look and secure those future arrangements, we will certainly update the market. I think we'll have some news as we go throughout Q3 and Q4 on that front.

Speaker #5: But we're preparing for it, so I think we're optimistic that this will continue to drive our European growth story, in addition to the other molecules we have in the space today.

Speaker #5: But we're quite excited about what we're seeing with ADTO5 and golimumab. On your second question, there are a few assets that remain, especially as we look at our pipeline, which is quite robust, as you know.

Speaker #5: Several are in various phases of early and mid-stage development that we are still in active licensing discussions around. What I would say, Christopher, is, as we look to secure those future arrangements, we will certainly update the market.

Speaker #5: I think we'll have some news as we go throughout Q3 and Q4 on that front. But the good news for us is, given the breadth of our pipeline, we do expect to continue to see contribution.

Joel Morales: But the good news for us is, given the breadth of our pipeline, we do expect to continue to see contribution from milestone revenues, both for the remainder of 2026 and as we look into 2027.

Lisa Graver: But the good news for us is, given the breadth of our pipeline, we do expect to continue to see contribution from milestone revenues, both for the remainder of 2026 and as we look into 2027.

Speaker #5: From milestone revenues, both for the remainder of '26 and as we look into '27.

Speaker #4: Okay, thanks. That's very helpful. If I could possibly ask a quick follow-up on the biosimilar—what's your expectation, or what could potential knock-on effects be beyond the EU?

Christopher Uhde: Okay, thanks. That is very helpful. If I could possibly ask a quick follow-up on the Bio-Thera. What is your expectation, or what could potential knock-on effects be beyond the EU? Thank you, and that is all for me.

Speaker #4: Thank you. And that's all from me.

Speaker #5: Yeah. So, I think from a U.S. perspective, certainly, you know, we can't comment on, you know, third parties, but what I would say is this.

Joel Morales: Yeah. From a US perspective, certainly, we cannot comment on third parties. But what I would say is this, we certainly have been positioning ourselves to, once we receive the approval, which we are optimistic to see in Q4. We are actively pursuing clearing any IP litigation as we speak, and we do feel very comfortable that we will be, if not the first, within that first wave in the very near term. So we will be positioned well, Christopher, as I said, both from an EU and US perspective, from a supply and preparedness point of view, to take advantage as we look to the remainder of this year and certainly into 2027.

Lisa Graver: Yeah. From a US perspective, certainly, we cannot comment on third parties. But what I would say is this, we certainly have been positioning ourselves to, once we receive the approval, which we are optimistic to see in Q4. We are actively pursuing clearing any IP litigation as we speak, and we do feel very comfortable that we will be, if not the first, within that first wave in the very near term. So we will be positioned well, Christopher, as I said, both from an EU and US perspective, from a supply and preparedness point of view, to take advantage as we look to the remainder of this year and certainly into 2027.

Speaker #5: We certainly have been positioning ourselves to, once we receive the approval—which we're optimistic to see in the fourth quarter—we're actively pursuing clearing any IP litigation as we speak.

Speaker #5: And we do feel very comfortable that we will be, if not the first, within that first wave in the very near term. So we'll be positioned well.

Speaker #5: Christopher, as I said, both from an EU and US perspective, from a supply and preparedness point of view, to take advantage as we look to the remainder of this year and certainly into 2027.

Speaker #4: Thank you very much.

Christopher Uhde: Thank you very much.

Speaker #2: Thank you. We will take our next question. Your next question comes from Ash Verma from UBS. Please go ahead, your line is open.

Operator: Thank you. We will take our next question. Your next question comes from Ash Verma from UBS. Please go ahead. Your line is open.

Ash Verma: Hey, team. Congratulations to all the progress. I wanted to ask about, first, just on this DEA that you received from the FDA for these US submissions. Just wanted to get the latest if there have been any additional communications from the FDA recently, and is there a formal acceptance of the resubmitted application? Or any other additional information requests that you received from the FDA that are outstanding at this point? Secondly, on SIMPONI, can you talk about your confidence on the launch timeline for Q4 of this year? I see this Johnson & Johnson lawsuit around the infringement on 14 patents related to the method of manufacturing. Just help us understand, do you need to resolve that to be able to launch, or is there a process by which you will be able to launch without finalizing the litigation? Thanks.

Speaker #6: Hi, team. Congratulations on all the progress. I wanted to ask about the first, just on this VEA that you received from the FDA for these US submissions.

Speaker #6: Just wanted to get the latest—if there have been any additional communications from the FDA recently. And is there a formal acceptance of the resubmitted application, or any other additional information request that you received from the FDA that is outstanding at this point?

Speaker #6: And then, secondly, on Symphony, can you talk about your confidence in the launch timeline for Q4 of this year? I see this J&J lawsuit around the infringement on 14 patents related to the method of manufacturing.

Speaker #6: Just help us understand. Do you need to resolve that to be able to launch, or is there a process by which you will be able to launch without finalizing the litigation?

Speaker #6: Thanks.

Speaker #7: Thank you. This is John McClellan. I will answer the first aspect regarding the resubmissions, and then I'll hand it over to answer the second part.

Joseph McClellan: Thank you. This is Joseph McClellan. I will answer the first aspect regarding the resubmissions, and then I will hand it over to answer the second part. Regarding the resubmissions, as we communicated in early June, all of our BLAs were submitted in the complete response. We did get an acknowledgment letter for all of the submitted BLAs from the FDA that the application was submitted. It was viewed as a complete response to the action letters we received in Q4 of 2025, and we were informed of goal dates in alignment with the six-month clock upon resubmission.

Speaker #7: So, regarding the resubmissions, as we communicated in early June, all of our BLAs were submitted. In the complete response, we did get an acknowledgment letter for all of the submitted BLAs from the FDA.

Speaker #7: The application was submitted. It was viewed as a complete response to the action letters we received in the fourth quarter of '25. We were informed of goal dates in alignment with the six-month clock upon resubmission.

Speaker #5: And on your second question, related to timing of launch—so, as we've stated in the past, we commercialize through partners, and we do not comment ahead of our partners in terms of precise launch timing.

Joel Morales: On your second question related to timing of launch. As we have stated in the past, we commercialize through partners, and we do not comment ahead of our partners in terms of precise launch timing. What I will say is we do expect to see a decision in the ongoing litigation in Q4 with respect to ourselves. We have also stated that we feel very strongly in our position that we will be able to be successful in that litigation, and certainly, that does pave the way to launch. So approval, again, as we noted, expected in Q4. We also expect to see a decision as part of the litigation that we are in that Q4. Again, we do feel very strongly in our IP position and that we will be successful ultimately in that litigation.

Lisa Graver: On your second question related to timing of launch. As we have stated in the past, we commercialize through partners, and we do not comment ahead of our partners in terms of precise launch timing. What I will say is we do expect to see a decision in the ongoing litigation in Q4 with respect to ourselves. We have also stated that we feel very strongly in our position that we will be able to be successful in that litigation, and certainly, that does pave the way to launch. So approval, again, as we noted, expected in Q4. We also expect to see a decision as part of the litigation that we are in that Q4. Again, we do feel very strongly in our IP position and that we will be successful ultimately in that litigation.

Speaker #5: But what I will say is, we do expect to see a decision in the ongoing litigation in the fourth quarter with respect to ourselves.

Speaker #5: We have also stated that we feel very strongly in our position, that we will be able to be successful in that litigation. And certainly, that does pave the way to launch.

Speaker #5: So approval, again, as we noted, is expected in the fourth quarter. We also expect to see a decision as part of the litigation that we're in, in that fourth quarter.

Speaker #5: And again, we do feel very strongly in our IP position, and that we will be successful ultimately in that litigation.

Ash Verma: Great. Thank you.

Speaker #6: Great. Thank you.

Speaker #2: Thank you. We will take our next question. And the question comes from Arvid Nakanda from DNB Carnegie. Please go ahead, your line is open.

Operator: Thank you. We will take our next question, and the question comes from Arvid Näsander from DNB Carnegie. Please go ahead. Your line is open.

Speaker #8: Good afternoon, and thanks for taking my questions. So the first one on ADTO5—sorry, ADT16. Has—or, sorry, has the BLA been accepted? How do you think about the US launch window here?

Arvid Näsander: Good afternoon, and thanks for taking my questions. The first one on AVT05, or sorry, AVT16. With the BLA accepted, how do you think about the US launch window here? Teva appears to view this as a 2028 or beyond opportunity, and market expectation seems to be quite limited by similar impacts until the early 2030s. Where do you realistically see the launch window today? My second one would be on expense versus capitalized development. First off, do you still stand by the roughly $250 million in total R&D spend for 2026? Secondly, consensus assumes a quite steep step-up in expense R&D from Q3. Does that make sense to you? Was there any sort of bolus or catch-up effect from the new capitalization policy that made the first half expense run rate unusually low?

Arvid Necander: Good afternoon, and thanks for taking my questions. The first one on AVT05, or sorry, AVT16. With the BLA accepted, how do you think about the US launch window here? Teva appears to view this as a 2028 or beyond opportunity, and market expectation seems to be quite limited by similar impacts until the early 2030s. Where do you realistically see the launch window today? My second one would be on expense versus capitalized development. First off, do you still stand by the roughly $250 million in total R&D spend for 2026? Secondly, consensus assumes a quite steep step-up in expense R&D from Q3. Does that make sense to you? Was there any sort of bolus or catch-up effect from the new capitalization policy that made the first half expense run rate unusually low?

Speaker #8: TEVA appears to view this as a 2028 or beyond opportunity and market expectation seems to be quite limited by similar impact until the early 2030s.

Speaker #8: So, where do you realistically see the launch window today? And then my second question would be on expensed versus capitalized development. So, first off, do you still stand by the roughly $250 million in total R&D spend for 2026?

Speaker #8: And secondly, consensus assumes a quite steep step up in expensed R&D from Q3. Does that make sense to you? Are there any sort of BOLAs or catch-up effects from the new capitalization policy that made the first half expense run rates unusually low?

Speaker #8: It would be great to get your comment on that. Thanks.

Arvid Näsander: It would be great to get your comment on that. Thanks.

Arvid Necander: It would be great to get your comment on that. Thanks.

Speaker #5: So maybe I'll start with ABT16. So again, we want to be careful in terms of precise launch timing. I do think with the submission, we are expecting an approval decision in early 2027.

Joel Morales: Well, maybe I'll start with AVT16. Again, one, being careful in terms of precise launch timing. I do think with the submission, we are expecting an approval decision in early 2027. We do feel quite comfortable in our IP position on AVT16. We certainly will be working with our partner to take advantage of every opportunity to bring this into a near-term launch. We think there is opportunity here, just given our positioning and how quickly we were able to file this in advance of the rest of the field. We will pursue this, and I think we will pursue this to the point where we can get a positive, of course, approval, but also a positive outcome in any patent litigation, which at this point we are not involved in.

Lisa Graver: Well, maybe I'll start with AVT16. Again, one, being careful in terms of precise launch timing. I do think with the submission, we are expecting an approval decision in early 2027. We do feel quite comfortable in our IP position on AVT16. We certainly will be working with our partner to take advantage of every opportunity to bring this into a near-term launch. We think there is opportunity here, just given our positioning and how quickly we were able to file this in advance of the rest of the field. We will pursue this, and I think we will pursue this to the point where we can get a positive, of course, approval, but also a positive outcome in any patent litigation, which at this point we are not involved in.

Speaker #5: We do feel quite comfortable in our IP position on ABT16. We certainly will be working with our partner to take advantage of every opportunity to bring this into a near-term launch.

Speaker #5: We think there is opportunity here, just given our positioning and how quickly we were able to file this in advance of the rest of the field.

Speaker #5: So we will pursue this, and I think we will pursue this to the point where we can get a positive, of course, approval but also a positive outcome in any patent litigation, which at this point we are not involved in.

Speaker #5: But to the extent that we do become — we do feel comfortable that we will be successful as well, and hope for a near-term contribution from ABT16.

Joel Morales: But to the extent that we do become, we do feel comfortable that we will be successful as well, and hope for a near-term contribution from AVT16.

Lisa Graver: But to the extent that we do become, we do feel comfortable that we will be successful as well, and hope for a near-term contribution from AVT16.

Linda Jónsdóttir: On the R&D part, looking at where we are today, with just over USD 100 million in total R&D spend and roughly 50% of that capitalized, I am expecting that trend to continue. So looking at the total year, around USD 200 million with 50% capitalized. In terms of Q3, Q4 R&D expense, I would say assuming pretty even split between the two quarters.

Speaker #7: On the R&D part, looking at where we are today, with just over $100 million in total R&D spend and roughly 50% of that capitalized, I'm expecting that trend to continue.

Speaker #7: So looking at the total year, around 200 with 50% capitalized. In terms of, like, Q3 and Q4 R&D expense, I would say, like, assuming a pretty even split between the two quarters.

Arvid Näsander: Great. Thank you.

Arvid Necander: Great. Thank you.

Speaker #8: Great. Thank you.

Speaker #2: Thank you. Once again, if you wish to ask a question, please press star one-one on your telephone. We will take our next question.

Operator: Thank you. Once again, if you wish to ask a question, please press star 1 1 on your telephone. We will take our next question, and the question comes from Glen Santangelo from Barclays. Please go ahead. Your line is open.

Speaker #2: And the question comes from Glenn Santangelos from Barclays. Please go ahead, your line is open.

Speaker #7: Oh, yeah. Good morning, and thanks for taking my question. I just wanted to ask a quick question about the guidance, and then I had a couple of follow-ups.

Glen Santangelo: Yeah, good morning, and thanks for taking my question. I just wanted to ask a quick question about the guidance, and then I have a couple of follow-ups. With respect to the guidance, I was hopeful that you could maybe unpack what the expectation is in terms of development milestones in the back half of the year, just given all the resubmissions and regulatory actions we're expecting. I'm kind of trying to parse it out because I fully appreciate the constraints that you've had on the manufacturing side, and you're expecting product revenues to reaccelerate, but I'm just trying to separate those two. Then maybe for Joel, I appreciate some of the comments you made, but I just wanted to verify what you said with respect to the timing of a couple of submissions.

Speaker #7: With respect to the guidance, I was hopeful that you could maybe unpack what the expectation is in terms of development milestones in the back half of the year.

Speaker #7: Just sort of given all the resubmissions and regulatory actions we're expecting. I'm kind of trying to parse that out because I fully appreciate the constraints that you've had on the manufacturing side and you're expecting product revenues to reaccelerate.

Speaker #7: But I'm just trying to separate those two. And then maybe, for Joe, I appreciate some of the comments you made. But I just wanted to verify what you said with respect to the timing of a couple of submissions.

Glen Santangelo: I think, Joel, you said EYLEA is a 2028 submission, if I heard that correctly, 2029? Then, the AVT80, I'm curious if you can sort of give us a timeline on that as well. Thanks.

Speaker #7: I think, Joe, you said ILEA is a 28 submission—if I heard that correctly, 29. And then the AVT80, I'm curious if you can sort of give us the timeline on that as well.

Speaker #7: Thanks.

Speaker #4: On the guidance? The guidance first, then I'll.

Arvid Näsander: On the guidance?

Joseph McClellan: On the guidance?

Linda Jónsdóttir: Yeah.

Linda Jónsdóttir: Linda, you want to start with the guidance first, and I'll-

Joseph McClellan: Linda, you want to start with the guidance first, and I'll-

Linda Jónsdóttir: I will start with the guidance first.

Speaker #7: I'll start with the guidance first. I mean, just thinking about the year holistically, and the timing of the upcoming approvals that will lay the foundation for a strong, full-year launch in '27.

Linda Jónsdóttir: Yeah.

Glen Santangelo: Yeah.

Linda Jónsdóttir: Just thinking about the year holistically and the timing of the upcoming approvals, that will lay the foundation for a strong full year from 2027. Given the late timing of the potential approvals this year, we do not expect any great contribution to the 2026 numbers from that. I would rather think about the year like we are targeting strong Q4. We are coming out of a period which has been impacted by slowdown, which is concluding at the end of Q2. We basically just started to operate close to full scale now at the end of Q2. Therefore, we can say on the product level, we are confident in having a strong Q4, because what we produce in Q2 will be a commercial product in Q4. Therefore, we are guiding the year with a strong Q4 on that basis.

Speaker #7: And given the late timing of the potential approvals this year, we do not expect any significant contribution to the 2026 numbers from that.

Speaker #7: So, I would rather think about the year like we are targeting a strong Q4. We are coming out of a period which has been impacted by a slowdown, which is concluding at the end of Q2.

Speaker #7: So, we basically just started to operate close to full scale now at the end of Q2. So, therefore, we can say, like, on the product level, we are confident in having a strong Q4 because, like, what we produce in Q2 will be commercial product in Q4.

Speaker #7: So, therefore, we are guiding the year with a strong Q4 on that basis. Also, taking into account, like Glenn says, we have on the licensing side and the timing there, which can always be lumpy.

Linda Jónsdóttir: Also taking into account the instances we have on the licensing side and the timing there, which can always be lumpy. I would say reaching the guidance with a strong Q4. Q3 will still be impacted from the ramp up that is happening now.

Speaker #7: So I would say reaching the guidance, like with a strong Q4. But, like, Q3 will still be impacted from the RAFTA that's happening now.

Speaker #7: Yeah, I mean, I kind of get all that, right? But I'm just trying to really understand how much licensing revenue is incorporated in the second half of the year guidance, so I can segregate, you know, how much strength we're going to see on the product side.

Glen Santangelo: Yeah. I kind of get all that, right? I am just trying to really understand how much licensing revenue is incorporated in the H2 guidance so I can segregate how much strength we are going to see on the product side.

Speaker #5: Yeah, I mean, maybe, Glenn, to just add to that—so I think it's going to be a contribution, clearly, from both. I mean, we don't break down quarterly.

Joel Morales: Yeah. Maybe, Glenn, to just add to that. I think it's going to be a contribution clearly from both. We don't break down quarterly license versus product. What I would say, in addition to what Linda already telegraphed, there are certain earned milestones that we're projecting, but there's also milestones likely coming from, as I mentioned, actively engaged in new deal licensing efforts as we speak. We do expect contribution from those activities through Q3, but most likely heavily weighted into Q4. So it is a mix. It's a healthy mix, blend between both product revenue contribution and milestone, with product increasingly contributing as we see Q4 come out.

Lisa Graver: Yeah. Maybe, Glenn, to just add to that. I think it's going to be a contribution clearly from both. We don't break down quarterly license versus product. What I would say, in addition to what Linda already telegraphed, there are certain earned milestones that we're projecting, but there's also milestones likely coming from, as I mentioned, actively engaged in new deal licensing efforts as we speak. We do expect contribution from those activities through Q3, but most likely heavily weighted into Q4. So it is a mix. It's a healthy mix, blend between both product revenue contribution and milestone, with product increasingly contributing as we see Q4 come out.

Speaker #5: License versus product. But what I would say, in addition to what Linda already telegraphed, is that there are certain earned milestones that we're projecting. But there are also milestones likely coming from, as I mentioned, actively engaging in new deal licensing efforts as we speak.

Speaker #5: And we do expect contribution from those activities through Q3, but most likely heavily weighted into Q4. So it is a mix. It's a healthy mix, Glenn, between both product revenue contribution and milestone, with product increasingly contributing as we see Q4 come out.

Speaker #7: Yeah. And, like, I mean, the only flavor we have given historically on the milestone side, in terms of numbers, is around—we've been saying it's somewhere around the 250 a year.

Linda Jónsdóttir: Yeah. The only flavor we have given historically on the milestone side in terms of numbers, we've been saying it's somewhere around the 250 a year. However, it can easily fluctuate up and down based on exact timing of it. So it can be lumpy, but that's the only number flavor we've given to it holistically.

Speaker #7: However, it can easily fluctuate up and down based on the exact timing of it. So it can be lumpy, but that's the only number flavor we've given to it holistically.

Speaker #7: Okay, that's helpful. And then my follow-up was the timing on AVT80 and AVT29, the timeline for submissions?

Glen Santangelo: Okay. That's helpful. My follow-up was the timing on AVT80 and AVT29, the timeline for submissions.

Speaker #4: Yeah, absolutely. So I'll take ILEA high dose first. For ILEA high dose in Europe, we have committed and stated that it is a 2026 event.

Joseph McClellan: Yep, absolutely. I'll take EYLEA high dose first. So for EYLEA high dose in Europe, we have committed and stated that it is a 2026 event. So we will be submitting that in Europe this year. Regarding a US submission for AVT29, we both filed similar to EYLEA HD. That does require a clinical study for submission in the US. That study has been initiated. We were the first to start a study on this, and that is anticipated to be a 2028 event. Regarding AVT80, as we've communicated, we have submitted both AVT16 and AVT80 to Europe. We have communicated our 16 submission already to the US, and we anticipate communicating very soon that we have submission of AVT80 in the US.

Speaker #4: So we will be submitting that in Europe this year. Regarding a US submission for AVT29, proposed value similar to ILEA HD, that does require a clinical study for submission in the US.

Speaker #4: That study has been initiated. We were the first to start a study on this, and that is anticipated to be a 2028 event.

Speaker #4: Regarding AVT80, as we communicated, we have submitted both AVT16 and AVT80 to Europe. We have already communicated our AVT16 submission to the US.

Speaker #4: And we anticipate communicating very soon that we have submitted AVT80 in the U.S.

Speaker #7: Okay. Thank you.

Glen Santangelo: Okay, thank you.

Speaker #2: Thank you. We will take our next question. Your question comes from the line of Christopher Ouda from SEB. Please go ahead. Your line is open.

Operator: Thank you. We will take our next question. Your question comes from the line of Christopher Uhde from SEB. Please go ahead. Your line is open. Christopher Uhde, your line is open. Please ask your question.

Speaker #2: Christopher Ouda, your line is open. Please ask your question.

Christopher Uhde: Oh, sorry. Yeah, sorry about that. I was on mute. My first question was, and thank you for taking my follow-ups, was on if there is anything you can give us about the status of the Fujifilm collaboration. Then secondly, what can you share about the provision that you took in the quarter? Was it related to the CRLs? Thank you.

Speaker #6: Oh, sorry. I was on—yeah, sorry about that. I was on mute. So, my first question was—and thank you for taking my follow-ups.

Speaker #6: Was wondering if there's anything you can give us about the status of the Fujifilm collaboration. And then secondly, what can you share about the provision that you took in the quarter?

Speaker #6: Was it related to the CRLs? Thank you.

Speaker #5: Hi, Christopher. On Fuji, we are progressing well. Activities are well underway. I think we have said previously that we expect to start to see product coming out of Fuji in the second half of '27, more towards the back half of '27.

Joel Morales: Hi, Christopher. On Fuji, we are progressing well. Activities are well underway. I think we have said previously we expect to start to see product coming out of Fuji in H2 2027, more towards the back half of 2027. We are on track for that. I would say the collaboration is going well, and we are continuing to look at other ways we can work with Fuji. On track, I think, is the message at this point.

Lisa Graver: Hi, Christopher. On Fuji, we are progressing well. Activities are well underway. I think we have said previously we expect to start to see product coming out of Fuji in H2 2027, more towards the back half of 2027. We are on track for that. I would say the collaboration is going well, and we are continuing to look at other ways we can work with Fuji. On track, I think, is the message at this point.

Speaker #5: We are on track for that. I would say the collaboration is going well, and we're continuing to look at other ways we can work with Fuji.

Speaker #5: So, on track, I think, is the message at this point.

Speaker #7: And on the provisioning, Linda here. So like I mean, it is about like commercial and contractual matters. And like, of course, giving the nature of and the size of a business and like the multiple partners we are working with, I think it's usual that provisions may be required from time to time.

Linda Jónsdóttir: Linda here. On the provisioning, it is about commercial and contractual matters. Of course, given the nature and the size of our business and the multiple partners we are working with, I think it is usual that provisions may be required from time to time, like when issues arise. We need to evaluate those topics carefully. However, the underlying details of it remains confidential, because it is commercially very sensitive. Unfortunately, I cannot really elaborate further on that now in this call.

Speaker #7: Like when issues arise, so like we are we need to evaluate those topics carefully. However, the underlying details of it remains confidential because it is like commercially very sensitive.

Speaker #7: So, unfortunately, I can't really elaborate further on that now during this call.

Speaker #6: Okay, understood. Thank you very much.

Christopher Uhde: Okay, understood. Thank you very much.

Speaker #2: Thank you. This concludes today's question-and-answer session. I will now hand back for closing remarks.

Operator: Thank you. This concludes today's question and answer session. I will now hand back for closing remarks.

Speaker #1: Yes, thank you. And on behalf of all of us here at Alvotech, I want to thank everybody who participated in today's call and wish you a very good rest of the day.

Róbert Wessman: Yes, thank you. On behalf of all of us here at Alvotech, I want to thank everybody who participated in today's call and wish you a very good rest of the day. Goodbye.

Speaker #1: Goodbye.

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