Q1 2026 Alvotech Earnings Call

Operator: Good day, and thank you for standing by. Welcome to the Alvotech Q1 2026 Earnings Conference Call. I would now like to hand it over to our first speaker, Benedikt Stefánsson, Vice President of Investor Relations. Please go ahead.

Operator: Good day, and thank you for standing by. Welcome to the Alvotech Q1 2026 Earnings Conference Call. I would now like to hand it over to our first speaker, Benedikt Stefánsson, Vice President of Investor Relations. Please go ahead.

Speaker #2: Good day, and thank you for standing by. Welcome to the Alvotech First Quarter 2026 earnings conference call. At this time, all participants are on a listen-only mode.

Speaker #2: After the speakers' presentation, we'll open up for questions. To ask a question during the session, you will need to press star 11 on your telephone; you will then hear an automated message advising your hand is raised.

Speaker #2: To withdraw your question, please press star 11 again. Please be advised that today's call is being recorded. I would now like to hand it over to our first speaker, Benedikt Stefansson, Vice President of Investor Relations.

Speaker #2: Please go ahead.

Speaker #3: Thank you, and welcome to our listeners. Yesterday evening, the company issued a press release announcing our financial results for the first quarter of 2026.

Benedikt Stefánsson: Thank you, and welcome to our listeners. Yesterday evening, the company issued a press release announcing our financial results for Q1 2026. Material accompanying today's earnings call, including a supplemental earnings report, providing additional operational details and business updates, and the presentation we'll be referring to on today's call, were also published on our investor portal, investors.alvotech.com, in the earnings calendar section under the heading Q1 2026 earnings call. 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.

Benedikt Stefánsson: Thank you, and welcome to our listeners. Yesterday evening, the company issued a press release announcing our financial results for Q1 2026. Material accompanying today's earnings call, including a supplemental earnings report, providing additional operational details and business updates, and the presentation we'll be referring to on today's call, were also published on our investor portal, investors.alvotech.com, in the earnings calendar section under the heading Q1 2026 earnings call. 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 #3: Material accompanying today's earnings call, including a supplemental earnings report, providing additional operational details and business updates, and the presentation will be referring to on today's call, were also published on our Investor Portal: investors.alvotech.com, in the earnings calendar section under the heading Q1 2026 earnings call.

Speaker #3: 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.

Speaker #3: 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; and Linda Jonsdottir, chief financial officer.

Benedikt Stefánsson: Presenting on today's call are Robert Wessman, Founder and Executive Chairman, Lisa Graver, Chief Executive Officer, and Linda Jónsdóttir, Chief Financial Officer. Robert will begin today's presentation with a summary of our progress with the US regulatory pathway and some key business highlights. Lisa will then present a commercial and pipeline update. Linda will conclude with a discussion of the financial results. Following the introductions, our team will be happy to take your questions. With that, I would like to turn the call over to Robert Wessman.

Benedikt Stefánsson: Presenting on today's call are Robert Wessman, Founder and Executive Chairman, Lisa Graver, Chief Executive Officer, and Linda Jónsdóttir, Chief Financial Officer. Robert will begin today's presentation with a summary of our progress with the US regulatory pathway and some key business highlights. Lisa will then present a commercial and pipeline update. Linda will conclude with a discussion of the financial results. Following the introductions, our team will be happy to take your questions. With that, I would like to turn the call over to Robert Wessman.

Speaker #3: Robert will begin today's presentation with a summary of our progress with the US regulatory pathway and some key business highlights. Lisa will then present a commercial and pipeline update.

Speaker #3: Linda will conclude with a discussion of the financial results. Following the introductions, our team will be happy to take your questions. With that, I would like to turn the call over to Robert Wessman.

Speaker #4: Good morning, everyone, and thank you for joining us. The first quarter was focused on three priorities: progressing the FDA resubmission, maintaining a high level of inspection readiness, and continuing to expand our commercial business globally, including the launch of three biosimilars across Europe and the rest of the world markets.

Robert Wessman: Good morning, everyone, and thank you for joining us. The Q1 was focused on 3 priorities: progressing the FDA resubmission, maintaining a high level of inspection readiness, and continuing to expand our commercial business globally, including the launch of 3 biosimilars across Europe and rest-of-the-world markets. Last week, the FDA began a routine GMP surveillance inspection at our Reykjavik facility, which is currently ongoing. Routine surveillance inspections are normal part of operating an FDA-regulated manufacturing facility, and our previous surveillance inspection took place in 2024. We continue to engage constructively with the agency throughout the process and expect it to be concluded by the end of business day tomorrow. Since our most recent pre-license inspection, which took place in July 2025, we have implemented several important enhancements across our quality system and the operations.

Robert Wessman: Good morning, everyone, and thank you for joining us. The Q1 was focused on three priorities: progressing the FDA resubmission, maintaining a high level of inspection readiness, and continuing to expand our commercial business globally, including the launch of three biosimilars across Europe and rest-of-the-world markets. Last week, the FDA began a routine GMP surveillance inspection at our Reykjavik facility, which is currently ongoing. Routine surveillance inspections are normal part of operating an FDA-regulated manufacturing facility, and our previous surveillance inspection took place in 2024. We continue to engage constructively with the agency throughout the process and expect it to be concluded by the end of business day tomorrow. Since our most recent pre-license inspection, which took place in July 2025, we have implemented several important enhancements across our quality system and the operations.

Speaker #4: Last week, the FDA began a routine GMP surveillance inspection at our Reykjavík facility, which is currently ongoing. Routine surveillance inspection are normal part of operating and FDA-regulated manufacturing facility, and our previous surveillance inspection took place in 2024.

Speaker #4: We continue to engage constructively with agency throughout the process and expect it to be concluded by the end of business day tomorrow. Since our most recent pre-license inspection, which took place in July 2025, we have implemented several important enhancements across our quality system and operations.

Speaker #4: The work to address the findings has been approached in highly structured and disciplined manner, and is well advanced. Importantly, we have deliberately taken additional time to substantially de-risk future operational and regulatory disruption and to ensure that when we resubmit, we do so with a package that fully addresses the agency's requirements and supports the long-term growth and value of the company.

Robert Wessman: The work to address the findings has been approached in highly structured and disciplined manner and is well advanced. Importantly, we have deliberately taken additional time to substantially de-risk future operational and regulatory disruption and to ensure that when we resubmit, we do so with a package that fully address the Agency's requirements and supports the long-term growth and value of the company. These actions have impacted manufacturing throughput, resulting in a slowdown at certain points during 2025 and Q1 2026. I'm very pleased with the progress the organization has made and the resubmission of our Biologics License Applications for our biosimilars to Simponi Aria, EYLEA, Prolia, and XGEVA are now in the final stages of completion.

Robert Wessman: The work to address the findings has been approached in highly structured and disciplined manner and is well advanced. Importantly, we have deliberately taken additional time to substantially de-risk future operational and regulatory disruption and to ensure that when we resubmit, we do so with a package that fully address the Agency's requirements and supports the long-term growth and value of the company. These actions have impacted manufacturing throughput, resulting in a slowdown at certain points during 2025 and Q1 2026. I'm very pleased with the progress the organization has made and the resubmission of our Biologics License Applications for our biosimilars to Simponi Aria, EYLEA, Prolia, and XGEVA are now in the final stages of completion.

Speaker #4: These actions have impacted manufacturing throughput, resulting in a slowdown at certain points during 2025 and the first quarter of 2026. But I'm very pleased with the progress the organization has made, and the resubmission of our Biologics License Applications for our biosimilars to Symphony, Symphony Aria, Eylea, Prolia, and Xgeva are now in the final stage of completion.

Speaker #4: As we complete the current resubmission process, we believe there is significant near-term value within our pipeline, which we believe is one of the most valuable in the industry today.

Robert Wessman: As we complete the current resubmission process, we believe there is significant near-term value within our pipeline, which we believe is one of the most valuable in the industry today. We are approaching a number of important milestones across several high-value programs that will drive the company's anticipated strong growth in 2027. This includes submissions in 2026 of biosimilar to Entyvio and the EYLEA high dose, and the resubmission for biosimilar to EYLEA, Simponi, Prolia, and XGEVA. These programs target large and growing biologics market and position us with the first wave of biosimilars entrants in their respective segments. Together with our leading pipeline of 30 biosimilar products, these submissions underscores the strengths and the momentum of our pipeline, which will support Alvotech's long-term growth.

Robert Wessman: As we complete the current resubmission process, we believe there is significant near-term value within our pipeline, which we believe is one of the most valuable in the industry today. We are approaching a number of important milestones across several high-value programs that will drive the company's anticipated strong growth in 2027. This includes submissions in 2026 of biosimilar to Entyvio and the EYLEA high dose, and the resubmission for biosimilar to EYLEA, Simponi, Prolia, and XGEVA. These programs target large and growing biologics market and position us with the first wave of biosimilars entrants in their respective segments. Together with our leading pipeline of 30 biosimilar products, these submissions underscores the strengths and the momentum of our pipeline, which will support Alvotech's long-term growth.

Speaker #4: We are approaching a number of important milestones across several high-value programs that will drive the company's anticipated strong growth in 2027. This includes submissions in 2026 of biosimilar to Antivio and Eilea high dose, and the resubmission for biosimilar to Eilea, Symphony, Prolia, and Xtiva.

Speaker #4: These programs target large and growing biologics markets and position us with the first wave of biosimilars entrants in their respective segments. Together with our leading pipeline of 30 biosimilar products, these submissions underscore the strengths and the momentum of our pipeline, which will support Alvotech's long-term growth.

Speaker #4: More broadly, we have built out one of the strongest integrated biosimilar platforms in the industry, combining resource and development, manufacturing, regulatory capabilities, and global commercial partnerships.

Robert Wessman: More broadly, we have built out one of the strongest integrated biosimilar platform in the industry, combining research and development, manufacturing, regulatory capabilities, and global commercial partnerships. With the platform now built, our focus has increasingly shifted towards execution, launches, and converting our pipeline into commercial growth. Alvotech entered the US market in mid-2024, marking the transition from an R&D-focused organization to a global commercial biosimilar company. Today, we have a commercial presence in over 90 countries and continue to expand patient access to biologics throughout the world. We believe the company is well-positioned for its next phase of growth. With that, I will hand the call over to Lisa.

Robert Wessman: More broadly, we have built out one of the strongest integrated biosimilar platform in the industry, combining research and development, manufacturing, regulatory capabilities, and global commercial partnerships. With the platform now built, our focus has increasingly shifted towards execution, launches, and converting our pipeline into commercial growth. Alvotech entered the US market in mid-2024, marking the transition from an R&D-focused organization to a global commercial biosimilar company. Today, we have a commercial presence in over 90 countries and continue to expand patient access to biologics throughout the world. We believe the company is well-positioned for its next phase of growth. With that, I will hand the call over to Lisa.

Speaker #4: With a platform now built, our focus has increasingly shifted towards execution, launches, and converting our pipeline into commercial growth. Alvotech entered the US market in mid-2024.

Speaker #4: Marking the transition from an R&D-focused organization to a global commercial biosimilar company. Today, we have a commercial presence in over 90 countries, and continue to expand patient access to biologics throughout the world.

Speaker #4: We believe the company is well positioned for its next phase of growth. And with that, I will hand the call over to Lisa.

Speaker #5: Thank you, Robert. Our primary focus during the quarter has been execution, both in relation to the regulatory process and in continuing to scale the commercial business globally.

Lisa Graver: Thank you, Robert. Our primary focus during the quarter has been execution, both in relation to the regulatory process and in continuing to scale the commercial business globally. As Robert noted, with the FDA now on site, we remain highly focused on a successful inspection outcome and on resubmitting the BLAs now pending approval. We believe the actions taken to date strengthen not only the specific resubmission packages, but the broader operational platform supporting future pipeline execution. We will provide the market with an update once the inspection has closed. As we continue to leverage our Reykjavik site for global supply, we have also been exploring additional manufacturing capacity, especially in the United States. Last night, we announced a manufacturing agreement with FUJIFILM Biotechnologies, covering multiple products within our portfolio. This agreement represents an important strategic step in further strengthening and diversifying our global manufacturing network, including expanded US-based manufacturing capability.

Lisa Graver: Thank you, Robert. Our primary focus during the quarter has been execution, both in relation to the regulatory process and in continuing to scale the commercial business globally. As Robert noted, with the FDA now on site, we remain highly focused on a successful inspection outcome and on resubmitting the BLAs now pending approval. We believe the actions taken to date strengthen not only the specific resubmission packages, but the broader operational platform supporting future pipeline execution. We will provide the market with an update once the inspection has closed. As we continue to leverage our Reykjavik site for global supply, we have also been exploring additional manufacturing capacity, especially in the United States. Last night, we announced a manufacturing agreement with FUJIFILM Biotechnologies, covering multiple products within our portfolio. This agreement represents an important strategic step in further strengthening and diversifying our global manufacturing network, including expanded US-based manufacturing capability.

Speaker #5: As Robert noted, with the FDA now on site, we remain highly focused on a successful inspection outcome and on resubmitting the BLAs now pending approval.

Speaker #5: We believe the actions taken to date strengthen not only the specific resubmission packages but the broader operational platform supporting future pipeline execution. We will provide the market with an update once the inspection has closed.

Speaker #5: As we continue to leverage our Reykjavík site for global supply, we have also been exploring additional manufacturing capacity, especially in the United States. Last night, we announced a manufacturing agreement with Fujifilm Biotechnologies, covering multiple products within our portfolio.

Speaker #5: This agreement represents an important strategic step in further strengthening and diversifying our global manufacturing network, including expanded US-based manufacturing capability. As our commercial portfolio in late-stage pipeline continue to scale, manufacturing resilience, supply reliability, and operational flexibility become increasingly important.

Lisa Graver: As our commercial portfolio and late-stage pipeline continue to scale, manufacturing resilience, supply reliability, and operational flexibility become increasingly important. This agreement enhances our ability to support future launches and long-term commercial growth while further strengthening supply continuity for our partners and patients. Fujifilm brings significant technical expertise and manufacturing capabilities, and we believe the agreement complements the strengths of our existing vertically integrated platform. We're in the process of initiating technology transfer activities and expect to begin supplying products for the US market in H2 2027 as the transfer and qualification process progresses. This additional capacity will become increasingly important as we move into the next phase of commercial launches and pipeline progression over the coming years. With respect to the financial performance in Q1, we had sales of $106 million and EBITDA of $24 million.

Lisa Graver: As our commercial portfolio and late-stage pipeline continue to scale, manufacturing resilience, supply reliability, and operational flexibility become increasingly important. This agreement enhances our ability to support future launches and long-term commercial growth while further strengthening supply continuity for our partners and patients. Fujifilm brings significant technical expertise and manufacturing capabilities, and we believe the agreement complements the strengths of our existing vertically integrated platform. We're in the process of initiating technology transfer activities and expect to begin supplying products for the US market in H2 2027 as the transfer and qualification process progresses. This additional capacity will become increasingly important as we move into the next phase of commercial launches and pipeline progression over the coming years. With respect to the financial performance in Q1, we had sales of $106 million and EBITDA of $24 million.

Speaker #5: This agreement enhances our ability to support future launches and long-term commercial growth, while further strengthening supply continuity for our partners and patients. Fujifilm brings significant technical expertise in manufacturing capabilities.

Speaker #5: And we believe the agreement complements the strengths of our existing vertically integrated platform. We're in the process of initiating technology transfer activities and expect to begin supplying products for the US market in the second half of 2027.

Speaker #5: As the transfer and qualification process progresses, this additional capacity will become increasingly important as we move into the next phase of commercial launches and pipeline progression over the coming years.

Speaker #5: With respect to the financial performance in the first quarter, we had sales of $106 million and EBITDA of $24 million. Both revenues and EBITDA were impacted by the timing of milestones, and the slowdown in production related to facility improvements.

Lisa Graver: Both revenues and EBITDA were impacted by the timing of milestones and a slowdown in production related to facility improvements, which reduced product revenues in the quarter. We do expect improvement in product revenues as normal operations resume through Q2 since underlying demand remains strong. Linda will provide more details later in the call. With respect to our marketed portfolio, we are seeing solid underlying demand trends and expanding adoption of biosimilars more broadly. For AVT02, our biosimilar to Humira, the US market continues to evolve as expected, with ongoing transition toward a multi-biosimilar market. Based on available market data, AVT02 has now become the fastest-growing biosimilar to Humira in the United States and achieved a 10% market share within the segment. In Europe and other international markets, AVT02 remains an important contributor to our commercial portfolio.

Lisa Graver: Both revenues and EBITDA were impacted by the timing of milestones and a slowdown in production related to facility improvements, which reduced product revenues in the quarter. We do expect improvement in product revenues as normal operations resume through Q2 since underlying demand remains strong. Linda will provide more details later in the call. With respect to our marketed portfolio, we are seeing solid underlying demand trends and expanding adoption of biosimilars more broadly. For AVT02, our biosimilar to Humira, the US market continues to evolve as expected, with ongoing transition toward a multi-biosimilar market. Based on available market data, AVT02 has now become the fastest-growing biosimilar to Humira in the United States and achieved a 10% market share within the segment. In Europe and other international markets, AVT02 remains an important contributor to our commercial portfolio.

Speaker #5: Which reduced product revenues in the quarter. We do expect improvement in product revenues as normal operations resume through the second quarter. Since underlying demand remains strong.

Speaker #5: Linda will provide more details later in the call. With respect to our marketed portfolio, we are seeing solid underlying demand trends and expanding adoption of biosimilars more broadly.

Speaker #5: For ABTO2, our biosimilar to Humira, the US market continues to evolve as expected, with ongoing transition toward a multi-biosimilar market. Based on available market data, ABTO2 has now become the fastest growing biosimilar to Humira in the United States.

Speaker #5: And achieved a 10% market share within the segment. In Europe and other international markets, ABTO2 remains an important contributor to our commercial portfolio. We believe there is further opportunity for biosimilar adoption as the overall market continues to grow.

Lisa Graver: We believe there is further opportunity for biosimilar adoption as the overall market continues to grow. For AVT04, our biosimilar to Stelara, Teva continues to expand Stelara's market through formulary and commercial execution. While in Europe, Uzpruvo continues to hold a leading share of the biosimilar segment in launched markets. We expect further biosimilar adoption and commercial growth across the ustekinumab market during 2026. For our biosimilars to Simponi, EYLEA, Prolia, and XGEVA, where we received approvals in Europe, UK, and Japan at the end of last year, our partners continue to progress launch activities. We remain optimistic on the commercial prospects for these products, particularly for AVT05, the biosimilar to Simponi, which remains the only biosimilar for the predominant presentation in the market.

Lisa Graver: We believe there is further opportunity for biosimilar adoption as the overall market continues to grow. For AVT04, our biosimilar to Stelara, Teva continues to expand Stelara's market through formulary and commercial execution. While in Europe, Uzpruvo continues to hold a leading share of the biosimilar segment in launched markets. We expect further biosimilar adoption and commercial growth across the ustekinumab market during 2026. For our biosimilars to Simponi, EYLEA, Prolia, and XGEVA, where we received approvals in Europe, UK, and Japan at the end of last year, our partners continue to progress launch activities. We remain optimistic on the commercial prospects for these products, particularly for AVT05, the biosimilar to Simponi, which remains the only biosimilar for the predominant presentation in the market.

Speaker #5: For ABTO4, our biosimilar to Stelara, Teva continues to expand Stelara's market through formulary and commercial execution. While in Europe, Ospruvo continues to hold a leading share of the biosimilar segment in launch markets.

Speaker #5: We expect further biosimilar adoption and commercial growth across the Oostakenema market during 2026. For our biosimilars to Symphony, Eilea, Prolia, and Xgeva, where we received approvals in Europe, UK, and Japan at the end of last year, our partners continue to progress launch activities.

Speaker #5: We remain optimistic on the commercial prospects for these products, particularly for ABTO5, the biosimilar to Symphony, which remains the only biosimilar for the predominant presentation in the market.

Speaker #5: Taken together, these launches continue to diversify our commercial portfolio, strengthen our revenue base across multiple geographies, and support the long-term value of our integrated biosimilars platform.

Lisa Graver: Taken together, these launches continue to diversify our commercial portfolio, strengthen our revenue base across multiple geographies, and support the long-term value of our integrated biosimilars platform. With respect to long-term value creation, there were a few highlights in the quarter regarding our pipeline. Our portfolio strategy remains highly selective and focused on molecules where we believe there is a compelling combination of market opportunity, durable mechanism of action, high scientific barriers to entry, manufacturing capability, and commercial attractiveness. Specifically, we are pleased to report that we have submitted a marketing authorization application to the European Medicines Agency for AVT16 and AVT80, our proposed biosimilars to Entyvio. Today, sales of Entyvio in Europe are close to $2 billion and growing.

Lisa Graver: Taken together, these launches continue to diversify our commercial portfolio, strengthen our revenue base across multiple geographies, and support the long-term value of our integrated biosimilars platform. With respect to long-term value creation, there were a few highlights in the quarter regarding our pipeline. Our portfolio strategy remains highly selective and focused on molecules where we believe there is a compelling combination of market opportunity, durable mechanism of action, high scientific barriers to entry, manufacturing capability, and commercial attractiveness. Specifically, we are pleased to report that we have submitted a marketing authorization application to the European Medicines Agency for AVT16 and AVT80, our proposed biosimilars to Entyvio. Today, sales of Entyvio in Europe are close to $2 billion and growing.

Speaker #5: With respect to long-term value creation, there were a few highlights of the quarter regarding our pipeline. Our portfolio strategy remains highly selective and focused on molecules where we believe there is a compelling combination of market opportunity, durable mechanism of action, high scientific barriers to entry, manufacturing capability, and commercial attractiveness.

Speaker #5: Specifically, we are pleased to report that we have submitted a marketing authorization application to the European Medicines Agency for ABT16 and ABT80. Our proposed biosimilars to Intivio.

Speaker #5: Today, sales of Intivio in Europe are close to $2 billion. And growing. Our biosimilar to Intivio represents a significant market opportunity in Europe, supported by strong underlying demand trends in inflammatory bowel disease.

Lisa Graver: Our biosimilar to Entyvio represents a significant market opportunity in Europe, supported by strong underlying demand trends in inflammatory bowel disease, and we believe we are well-positioned to be within the first wave, if not the first biosimilar for this product. Turning to the biosimilar of high-dose EYLEA, AVT29, we are on track to submit a marketing authorization application with the EMA in 2026. In addition, we have enrolled the first patients in the pivotal efficacy and safety study for AVT29 in support of the submission in the US in 2028. With this, we believe we could be the first to submit a biosimilar to high-dose EYLEA in Europe and the US. Today, the combined low-dose and high-dose market for EYLEA is approximately $8 billion, with $5 billion in the US and $3 billion in Europe.

Lisa Graver: Our biosimilar to Entyvio represents a significant market opportunity in Europe, supported by strong underlying demand trends in inflammatory bowel disease, and we believe we are well-positioned to be within the first wave, if not the first biosimilar for this product. Turning to the biosimilar of high-dose EYLEA, AVT29, we are on track to submit a marketing authorization application with the EMA in 2026. In addition, we have enrolled the first patients in the pivotal efficacy and safety study for AVT29 in support of the submission in the US in 2028. With this, we believe we could be the first to submit a biosimilar to high-dose EYLEA in Europe and the US. Today, the combined low-dose and high-dose market for EYLEA is approximately $8 billion, with $5 billion in the US and $3 billion in Europe.

Speaker #5: And we believe we are well positioned to be within the first wave, if not the first, biosimilar for this product. Turning to the biosimilar of high-dose Eylea, ABT29, we are on track to submit a marketing authorization application with the EMA in 2026.

Speaker #5: In addition, we have enrolled the first patients in the pivotal efficacy and safety study for ABT29 in support of a submission in the US in 2028.

Speaker #5: With this, we believe we could be the first to submit a biosimilar to high-dose Eilea in Europe and the US. Today, the combined low-dose and high-dose market for Eilea is approximately $8 billion.

Speaker #5: With $5 billion in the US and $3 billion in Europe. Together with our biosimilar to low-dose Eilea, Alvotech is well positioned to participate in the future evolution of the global Eilea market.

Lisa Graver: Together with our biosimilar to low-dose EYLEA, Alvotech is well-positioned to participate in the future evolution of the global EYLEA market as longer-acting dosing regimens become increasingly important. As we look ahead, our focus remains on disciplined execution across the commercial business, the regulatory process, and the pipeline. With that, I hand the call over to Linda to review the financial results in more detail.

Lisa Graver: Together with our biosimilar to low-dose EYLEA, Alvotech is well-positioned to participate in the future evolution of the global EYLEA market as longer-acting dosing regimens become increasingly important. As we look ahead, our focus remains on disciplined execution across the commercial business, the regulatory process, and the pipeline. With that, I hand the call over to Linda to review the financial results in more detail.

Speaker #5: As longer-acting dosing regimens become increasingly important. As we look ahead, our focus remains on disciplined execution across the commercial business, the regulatory process, and the pipeline.

Speaker #5: With that, I hand the call over to Linda to review the financial results in more detail.

Speaker #6: Thank you, Lisa. I will now take you through the financial results for the first quarter of 2026. Unless otherwise stated, the figures I will go through are adjusted numbers.

Linda Jónsdóttir: Thank you, Lisa. I will now take you through the financial results for Q1 2026. Unless otherwise stated, the figures I will go through are adjusted numbers. Reconciliations to the corresponding IFRS measures are included in our earnings materials, which have been published on our investor portal at investors.alvotech.com. Turning to the financial highlights for Q1 2026. Total revenues in Q1 were $106 million, representing a 20% decline compared to the same quarter last year. As stated in our previous year's earnings call, we are still seeing impact on our financials from our facility improvements and the associated slowdown, and we are expecting Q4 2026 to be the strongest quarter of the year. Gross margin for Q1 was 57%, an improvement of 6 basis points compared to the same period last year.

Linda Jónsdóttir: Thank you, Lisa. I will now take you through the financial results for Q1 2026. Unless otherwise stated, the figures I will go through are adjusted numbers. Reconciliations to the corresponding IFRS measures are included in our earnings materials, which have been published on our investor portal at investors.alvotech.com. Turning to the financial highlights for Q1 2026. Total revenues in Q1 were $106 million, representing a 20% decline compared to the same quarter last year. As stated in our previous year's earnings call, we are still seeing impact on our financials from our facility improvements and the associated slowdown, and we are expecting Q4 2026 to be the strongest quarter of the year. Gross margin for Q1 was 57%, an improvement of 6 basis points compared to the same period last year.

Speaker #6: Reconciliations to the corresponding IFRS measures are included in our earnings materials, which have been published on our investor portal at investors.alvotech.com. Turning to the financial highlights for Q1 2026.

Speaker #6: Total revenues in the first quarter were $106 million, representing a 20% decline compared to the same quarter last year. As stated in our previous year's earnings call, we are still seeing impact on our financials from our facility improvements and the associated slowdown, and we are expecting Q4 2026 to be the strongest quarter of the year.

Speaker #6: Gross margin for the first quarter was 57%, an improvement of six basis points compared to the same period last year. This reflects the blend of product and licensing revenues in the quarter, which was equally split.

Linda Jónsdóttir: This reflects the blend of product and licensing revenues in the quarter, which was equally split. Product margin in the quarter was 11%. Margins during the H2 2025 and Q1 2026 have been impacted by reduced manufacturing throughput associated with facility improvements at the Reykjavik site. As manufacturing normalizes and volumes recover, Alvotech will be positioned to enter 2027 with a stronger margin profile. Adjusted EBITDA in the Q1 was $24 million, representing a margin of 23% versus EBITDA of $21 million, representing a margin of 15% in Q1 2025. We have recently seen changes in regulatory guidance from both the FDA and the EMA, including where comparable clinical studies can be waived. This places greater emphasis on analytical similarity for approval. That means we can demonstrate technical feasibility earlier in the process.

Linda Jónsdóttir: This reflects the blend of product and licensing revenues in the quarter, which was equally split. Product margin in the quarter was 11%. Margins during the H2 2025 and Q1 2026 have been impacted by reduced manufacturing throughput associated with facility improvements at the Reykjavik site. As manufacturing normalizes and volumes recover, Alvotech will be positioned to enter 2027 with a stronger margin profile. Adjusted EBITDA in the Q1 was $24 million, representing a margin of 23% versus EBITDA of $21 million, representing a margin of 15% in Q1 2025. We have recently seen changes in regulatory guidance from both the FDA and the EMA, including where comparable clinical studies can be waived. This places greater emphasis on analytical similarity for approval. That means we can demonstrate technical feasibility earlier in the process.

Speaker #6: Product margin in the quarter was 11%. Margins during the second half of 2025 and Q1 2026 have been impacted by reduced manufacturing throughput associated with facility improvements at our Reykjavík site.

Speaker #6: As manufacturing normalizes and volumes recover, Alvotech will be positioned to enter 2027 with a stronger margin profile. Adjusted EBITDA in the first quarter was 24 million dollars.

Speaker #6: Representing a margin of 23% versus EBITDA of 21 million representing a margin of 15% in Q1 2025. We have recently seen changes in regulatory guidelines from both the FDA and the EMA, including where comparable clinical studies can be waived.

Speaker #6: This places greater emphasis on analytical similarity for approval; that means we can demonstrate technical feasibility earlier in the process. As a result, certain development programs now meet the criteria for capitalization under IFRS standard IAS 38 at an earlier stage.

Linda Jónsdóttir: As a result, certain development programs now meet the criteria for capitalization under IFRS Standard IAS 38 at an earlier stage. This has increased the proportion of development costs that are capitalized, and the updated approach has been applied prospectively from the beginning of 2026. Further on revenues. About half of the revenues in Q1 2026 come from product revenues, leveraging the continued commercial momentum. As we have discussed in the past, there is typically a timing lag between our partner sales performance and the recognition of revenue in our results. As a result, strong partner performance typically flows through into our reported revenue over subsequent periods as the year progresses. Product revenues for Q1 were $51 million. The key contributors were our biosimilar to Humira, AVT02, and our biosimilar to Stelara, AVT04.

Linda Jónsdóttir: As a result, certain development programs now meet the criteria for capitalization under IFRS Standard IAS 38 at an earlier stage. This has increased the proportion of development costs that are capitalized, and the updated approach has been applied prospectively from the beginning of 2026. Further on revenues. About half of the revenues in Q1 2026 come from product revenues, leveraging the continued commercial momentum. As we have discussed in the past, there is typically a timing lag between our partner sales performance and the recognition of revenue in our results. As a result, strong partner performance typically flows through into our reported revenue over subsequent periods as the year progresses. Product revenues for Q1 were $51 million. The key contributors were our biosimilar to Humira, AVT02, and our biosimilar to Stelara, AVT04.

Speaker #6: This has increased the proportion of development costs that are capitalized and the updated approach has been applied prospectively from the beginning of 2026. Further on revenues.

Speaker #6: About half of the revenues in the first quarter of 2026 come from product revenues, leveraging the continued commercial momentum. As we have discussed in the past, there is typically a timing lag between our partner sales performance and the recognition of revenue in our results.

Speaker #6: As a result, strong partner performance typically flows through into our reported revenue over subsequent periods as the year progresses. Product revenues for the first quarter were 51 million dollars.

Speaker #6: The key contributors were our biosimilar to Humira, ABT02, and our biosimilar to Stelara, ABT04, our three newly approved products, ABT03, our biosimilar to Prolia and Xtiva, ABT05, our biosimilar to Symphony, and ABT06, our biosimilar to Eilea, also began contributing incremental product revenues as launches expanded across Europe, the UK, and Japan.

Linda Jónsdóttir: Our three newly approved products, AVT03, our biosimilar to Prolia and Xgeva, AVT05, our biosimilar to Simponi, and AVT06, our biosimilar to EYLEA, also began contributing incremental product revenues as launches expanded across Europe, the UK, and Japan. Licensing revenues for the quarter were $55 million. As we have noted on previous calls, milestone revenue recognition is inherently lumpy, driven by the timing of development progress, regulatory submissions, and contractual milestones achieved with our commercial partners. Turning to cash flow. Cash at hand at the end of the quarter is $64 million, while operating cash flow is negative in the quarter by -$25 million, driven mostly by working capital. As you can see from the cash flow bridge, other drivers impacting our cash flow in the quarter were net interest payments of $35 million per quarter following the transition from PIK to cash interest mid-2025.

Linda Jónsdóttir: Our three newly approved products, AVT03, our biosimilar to Prolia and Xgeva, AVT05, our biosimilar to Simponi, and AVT06, our biosimilar to EYLEA, also began contributing incremental product revenues as launches expanded across Europe, the UK, and Japan. Licensing revenues for the quarter were $55 million. As we have noted on previous calls, milestone revenue recognition is inherently lumpy, driven by the timing of development progress, regulatory submissions, and contractual milestones achieved with our commercial partners. Turning to cash flow. Cash at hand at the end of the quarter is $64 million, while operating cash flow is negative in the quarter by -$25 million, driven mostly by working capital. As you can see from the cash flow bridge, other drivers impacting our cash flow in the quarter were net interest payments of $35 million per quarter following the transition from PIK to cash interest mid-2025.

Speaker #6: Licensing revenues for the quarter were 55 million dollars. As we have noted on previous calls, milestone revenue recognition is inherently lengthy, driven by the timing of development progress, regulatory submissions, and contractual milestones achieved with our commercial partners.

Speaker #6: Turning to cash flow. Cash at hand at the end of the quarter is 64 million dollars, while operating cash flow is negative in the quarter by 25 million dollars.

Speaker #6: Driven mostly by working capital. As you can see from the cash flow grids, other drivers impacting our cash flow in the quarter were net interest payments of 35 million per quarter, following the transition from peak to cash interest, mid-2025.

Linda Jónsdóttir: CapEx at USD 7 million in the quarter and was low in line with plans. Investment in accountables is $39 million in the quarter, and we remain focused on achieving positive free cash flow in Q4 2026, which continues to be a key financial priority. Looking into our balance sheet. I will start with briefly summarizing key items on the asset side of our balance sheet. We have a strong asset base, which has been supported by strategic acquisitions in 2025 and pipeline investments. From year-end 2025, non-current assets were up by $52 million, mainly driven by an increase in accountable assets and higher contract assets due to the timing of revenue recognition. Total current assets decreased by $118 million due to collections of trade receivables and reduction in cash to finance operating activities and debt service in the quarter.

Linda Jónsdóttir: CapEx at USD 7 million in the quarter and was low in line with plans. Investment in accountables is $39 million in the quarter, and we remain focused on achieving positive free cash flow in Q4 2026, which continues to be a key financial priority. Looking into our balance sheet. I will start with briefly summarizing key items on the asset side of our balance sheet. We have a strong asset base, which has been supported by strategic acquisitions in 2025 and pipeline investments. From year-end 2025, non-current assets were up by $52 million, mainly driven by an increase in accountable assets and higher contract assets due to the timing of revenue recognition. Total current assets decreased by $118 million due to collections of trade receivables and reduction in cash to finance operating activities and debt service in the quarter.

Speaker #6: Capex at 7 million in the quarter and was low in line with plans. Investment in untenables is 39 million dollars in the quarter. And we remain focused on achieving positive free cash flow in Q4 2026, which continues to be a key financial priority.

Speaker #6: Then looking into our balance sheet. I will start with briefly summarizing key items on the asset side asset base which has been supported by strategic acquisitions in 2025 and pipeline investments.

Speaker #6: From year-end 2025, non-current assets were up by 52 million dollars, mainly driven by an increase in untenable assets and higher contract assets due to the timing of revenue recognition.

Speaker #6: Total current assets, decreased by 118 million dollars due to collections of trade receivables and reduction in cash to finance operating activities and debt service in the quarter.

Speaker #6: Next, a few notes on the key moments across equity and liabilities. Derivative financial liabilities reduced by 32 million dollars, mainly due to fair value changes on conversion futures and earnout shares.

Linda Jónsdóttir: Next, a few notes on the key movements across equity and liabilities. Derivative financial liabilities reduced by $32 million, mainly due to fair value changes on conversion futures and earn-out shares. Trade and other payables decreased by $28 million due to investments and timing of orders in Q4 2025. Contract liabilities decreased due to recognition of licensing revenues as development milestones have been achieved. Turning to our financial outlook for the full year. We target revenues in the range of $650 to 700 million, representing continued double-digit growth compared to 2025. Adjusted EBITDA is expected to be in the range of $180 to 220 million. As a reminder, the lower end of our revenue guidance range does not include revenues from the approvals and launches of AVT03, AVT05, or AVT06 in the US.

Linda Jónsdóttir: Next, a few notes on the key movements across equity and liabilities. Derivative financial liabilities reduced by $32 million, mainly due to fair value changes on conversion futures and earn-out shares. Trade and other payables decreased by $28 million due to investments and timing of orders in Q4 2025. Contract liabilities decreased due to recognition of licensing revenues as development milestones have been achieved. Turning to our financial outlook for the full year. We target revenues in the range of $650 to 700 million, representing continued double-digit growth compared to 2025. Adjusted EBITDA is expected to be in the range of $180 to 220 million. As a reminder, the lower end of our revenue guidance range does not include revenues from the approvals and launches of AVT03, AVT05, or AVT06 in the US.

Speaker #6: Trade and other payables decreased by 28 million dollars due to investments and timing of orders in Q4 2025. Contract liabilities decreased due to recognition of licensing revenues as development milestones have been achieved.

Speaker #6: Turning to our financial outlook for the full year. We target revenues in the range of 650 to 700 million dollars, representing continued double-digit growth compared to 2025.

Speaker #6: Adjusted EBITDA is expected to be in the range of 180 to 220 million dollars. As a reminder, the lower end of our revenue guidelines range does not include revenues from the approvals and launches of ABT03, ABT05, or ABT06 in the US, as we look ahead to 2027.

Linda Jónsdóttir: As we look ahead to 2027, we expect to deliver strong year-on-year growth driven by continued expansion of our commercialized product portfolio, contributions from our pipeline, and associated milestone revenues. We also expect to benefit from increasing manufacturing output following the completion of the facility improvements and operational enhancements implemented since mid-2025. With respect to our balance sheet, the anticipated growth in 2027 will allow us to be in a position to deliver healthy leverage in 2027, which will open up further opportunities for us to optimize our capital structure. With that, I will hand the call back to the operator for Q&A.

Linda Jónsdóttir: As we look ahead to 2027, we expect to deliver strong year-on-year growth driven by continued expansion of our commercialized product portfolio, contributions from our pipeline, and associated milestone revenues. We also expect to benefit from increasing manufacturing output following the completion of the facility improvements and operational enhancements implemented since mid-2025. With respect to our balance sheet, the anticipated growth in 2027 will allow us to be in a position to deliver healthy leverage in 2027, which will open up further opportunities for us to optimize our capital structure. With that, I will hand the call back to the operator for Q&A.

Speaker #6: We expect to deliver strong year-on-year growth driven by continued expansion of our commercialized product portfolio contributions from our pipeline and associated milestone revenues. We also expect to benefit from increasing manufacturing output following the completion of the facility improvements and operational enhancements implemented since mid-2025.

Speaker #6: With respect to our balance sheet, the anticipated growth in 2027 will allow us to be in a position to deliver healthy leverage in 2027, which will open up further opportunities for us to optimize our capital structure.

Speaker #6: With that, I will hand the call back to the operator for Q&A.

Speaker #1: Thank you. And as a reminder, to ask a question, you will need to press star 11 on your telephone and wait for a name to be announced to withdraw your question.

Operator: Thank you. As a reminder, to ask a question, you will need to press star 11 on your telephone and wait for a name to be announced. To withdraw your question, please press star 11 again. Please limit yourself to one question and one follow-up in the interest of time. Please stand by while we compile the Q&A roster. One moment for our first question. Our first question will come from the line of Christopher Uhde from SEB. Your line is open.

Operator: Thank you. As a reminder, to ask a question, you will need to press star 11 on your telephone and wait for a name to be announced. To withdraw your question, please press star 11 again. Please limit yourself to one question and one follow-up in the interest of time. Please stand by while we compile the Q&A roster. One moment for our first question. Our first question will come from the line of Christopher Uhde from SEB. Your line is open.

Speaker #1: Please press star 1-1 again. Please limit yourself to one question and one follow-up in the interest of time. Please stand by while we compile the Q&A roster.

Speaker #1: One moment for our first question. Our first question will come from the line of Christopher Uday from SEB. Your line is open.

Christopher Uhde: Hi there. Thanks very much for taking my questions. Two for me, please, to start. The first would be on the Fujifilm partnership and its implications. Is this just ensuring less scope for regulatory commercial disruption from politics and so on? Or, you know, how critical was getting this partnership, and should we see it as having a tangible impact on your growth trajectory? Perhaps you can put that in the context then of the consolidation we've seen in the you know, during the, I guess, quarter and after within the industry. My second question is, based on your comments, it seems like SIMLANDI is taking share in the US, looking at Q4 versus now, whereas risperidone seems sort of flattish, possibly down somewhat in Europe.

Speaker #3: Hi there. Thanks very much for taking my questions. Two for me, please, to start. So the first would be on the Fujifilm partnership and its implications.

Christopher Uhde: Hi there. Thanks very much for taking my questions. Two for me, please, to start. The first would be on the Fujifilm partnership and its implications. Is this just ensuring less scope for regulatory commercial disruption from politics and so on? Or, you know, how critical was getting this partnership, and should we see it as having a tangible impact on your growth trajectory? Perhaps you can put that in the context then of the consolidation we've seen in the you know, during the, I guess, quarter and after within the industry. My second question is, based on your comments, it seems like SIMLANDI is taking share in the US, looking at Q4 versus now, whereas risperidone seems sort of flattish, possibly down somewhat in Europe.

Speaker #3: So is this just ensuring less scope for regulatory commercial disruption from politics and so on, or how critical was getting this partnership and should we see it as having a tangible impact on your growth trajectory?

Speaker #3: And then perhaps you can put that in the context then of the consolidation we've seen in the during the, I guess, quarter and after within the industry.

Speaker #3: And then my second question is, so based on your comments, it seems like Simlandia is taking share in the US, looking at Q4 versus now, whereas Rispruvo seems sort of flattish, possibly down somewhat in Europe.

Speaker #3: What can you tell us about sort of market share position within markets? I mean, is it stable or more fluid than overall position? And are there any kinds of sort of factors that we can think about that are driving those dynamics?

Christopher Uhde: What can you tell us about sort of market share position within markets? I mean, is it stable or more fluid than overall position? Are there any kind of, sort of factors that we can think about that are driving those dynamics? Thank you.

Christopher Uhde: What can you tell us about sort of market share position within markets? I mean, is it stable or more fluid than overall position? Are there any kind of, sort of factors that we can think about that are driving those dynamics? Thank you.

Speaker #3: Thank you.

Speaker #4: Hi, Christopher. Thanks for the question. Maybe taking the FujiFilm question first. So as we talked about on the last earnings call, we were in advanced discussions it is very much a strategic move for us.

Lisa Graver: Hi, Christopher. Thanks for the question. Maybe taking the Fujifilm question first. As we talked about on the last earnings call, we were in advanced discussions. It is very much a strategic move for us. Obviously happy that we were able to bring this across the finish line as quickly as we did. It really is what we said it was. It is an ability for us to diversify our capacity across markets. Certainly having a presence in the United States as well, does give us the advantage, being one of our large markets. I think from a perspective of timing, as we've said, that we do expect to introduce product for the US market specifically, in H2 2027.

Lisa Graver: Hi, Christopher. Thanks for the question. Maybe taking the Fujifilm question first. As we talked about on the last earnings call, we were in advanced discussions. It is very much a strategic move for us. Obviously happy that we were able to bring this across the finish line as quickly as we did. It really is what we said it was. It is an ability for us to diversify our capacity across markets. Certainly having a presence in the United States as well, does give us the advantage, being one of our large markets. I think from a perspective of timing, as we've said, that we do expect to introduce product for the US market specifically, in H2 2027.

Speaker #4: Obviously, happy that we were able to bring this across the finish line as quickly as we did. It really is what we said it was.

Speaker #4: It is an ability for us to diversify our capacity across markets. Certainly, having the presence in the United States as well does give us the advantage being one of our large markets.

Speaker #4: But I think from a perspective of timing, as we've said, that we do expect to introduce product for the US market specifically in the second half of 2027.

Speaker #4: So all of this was really aimed at continuing to ensure that supply chain reliability as we continue to see demand. And maybe heading into your next question, that demand is really being pulled through primarily in the US with Simlandia.

Lisa Graver: All of this was really aimed at continuing to ensure that supply chain reliability as we continue to see demand. Maybe heading into your next question, that demand is really being pulled through primarily in the US with SIMLANDI. Teva has done a fantastic job continuing to grow that for us, as well as just the natural evolution towards biosimilars in the market. I think we're sitting at about an exit share of 60% of the market being biosimilar in the US now. It's a combination of just commercial execution as well as just overall growth in the biosimilar segment. Clearly, anything we can do that will continue to ensure that we meet that demand across our manufacturing platform is something that we're going to prioritize.

Lisa Graver: All of this was really aimed at continuing to ensure that supply chain reliability as we continue to see demand. Maybe heading into your next question, that demand is really being pulled through primarily in the US with SIMLANDI. Teva has done a fantastic job continuing to grow that for us, as well as just the natural evolution towards biosimilars in the market. I think we're sitting at about an exit share of 60% of the market being biosimilar in the US now. It's a combination of just commercial execution as well as just overall growth in the biosimilar segment. Clearly, anything we can do that will continue to ensure that we meet that demand across our manufacturing platform is something that we're going to prioritize.

Speaker #4: Teva has done a fantastic job continuing to grow that for us, as well as just the natural evolution towards biosimilars in the market. I think we're sitting at about an exit share of 60% of the market being biosimilar in the US now.

Speaker #4: So it's a combination of just commercial execution as well as just overall growth in the biosimilar segment. So clearly, anything we can do that will continue to ensure that we meet that demand across our manufacturing platform is something that we're going to prioritize.

Speaker #4: In terms of Ustakinamab, particularly in Europe, we are seeing somewhat of a flattening in Q1. I will say we still have three quarters to go.

Lisa Graver: In terms of ustekinumab, particularly in Europe, we are seeing somewhat of a flattening in Q1. I will say we still have 3 quarters to go. I'm not going to say today that that's the trend we expect. We are still seeing the Stelara biosimilar market grow in Europe as well as in the US. It's sitting at about 56% at biosim now in Europe. I think there's still opportunity there. Certainly, we are seeing growth in Germany. Not unexpected. Germany is one of the key markets for us across our biosimilar platform. Certainly, we are still seeing that growth. I think from our perspective, growth will continue in the US.

Lisa Graver: In terms of ustekinumab, particularly in Europe, we are seeing somewhat of a flattening in Q1. I will say we still have 3 quarters to go. I'm not going to say today that that's the trend we expect. We are still seeing the Stelara biosimilar market grow in Europe as well as in the US. It's sitting at about 56% at biosim now in Europe. I think there's still opportunity there. Certainly, we are seeing growth in Germany. Not unexpected. Germany is one of the key markets for us across our biosimilar platform. Certainly, we are still seeing that growth. I think from our perspective, growth will continue in the US.

Speaker #4: I'm not going to say today that that's the trend we expect. We are still seeing the Stelara biosimilar market grow in Europe as well as in the US.

Speaker #4: It's sitting at about 56% at Biosim now in Europe. So I think there's still opportunity there. Certainly, we are seeing growth in Germany not unexpected.

Speaker #4: Germany is one of the key markets for us across our biosimilar platform. But certainly, we are still seeing that growth. So I think from our perspective, growth will continue.

Speaker #4: In the US, in Europe, we are seeing some stability through Q1, but I think we clearly have the remainder of the year to go.

Lisa Graver: In Europe, we are seeing some stability through Q1, but I think we clearly have the remainder of the year to go. Optimistic we'll still see some further top line growth there.

Lisa Graver: In Europe, we are seeing some stability through Q1, but I think we clearly have the remainder of the year to go. Optimistic we'll still see some further top line growth there.

Speaker #4: So optimistic we'll still see some further top-line growth there.

Speaker #3: Thanks. Just a clarification on the first one. What sort of proportion of your US sales should we think about as coming from Fujifilm in the future?

Christopher Uhde: Thanks. Just a clarification on the first one. What sort of proportion of your US sales.

Christopher Uhde: Thanks. Just a clarification on the first one. What sort of proportion of your US sales.

Christopher Uhde: Should we think about as coming from Fujifilm in the future? I mean, is it a majority or is it a minority, or any detail you can give there?

Christopher Uhde: Should we think about as coming from Fujifilm in the future? I mean, is it a majority or is it a minority, or any detail you can give there?

Speaker #3: I mean, is it a majority or is it a minority or any detail you can give there?

Lisa Graver: Yeah. I think it's too early to say for, from our perspective what I mean, we're going to leverage across our platform to ensure that, you know, we hit our markets. I think at this point in time, a little too soon to exactly give type of breakdown, but there's no question that the Reykjavik site will continue to be a predominant player across the markets. We will continue to look at ways to leverage both the Fuji site as well as our Reykjavik site.

Lisa Graver: Yeah. I think it's too early to say for, from our perspective what I mean, we're going to leverage across our platform to ensure that, you know, we hit our markets. I think at this point in time, a little too soon to exactly give type of breakdown, but there's no question that the Reykjavik site will continue to be a predominant player across the markets. We will continue to look at ways to leverage both the Fuji site as well as our Reykjavik site.

Speaker #4: Yeah, I think it's too early to say from our perspective what. I mean, we're going to leverage across our platform to ensure that we hit our markets.

Speaker #4: So I think at this point in time, a little too soon to give type of breakdown. But there's no question that the Reykjavik site will continue to be a predominant player across the markets.

Speaker #4: But we will continue to look at ways to leverage both the Fuji site as well as our Reykjavik site.

Speaker #3: Great. Thanks so much. I'll get back to you.

Christopher Uhde: Great. Thanks so much. I'll get back with you.

Christopher Uhde: Great. Thanks so much. I'll get back with you.

Speaker #1: Thank you. Once again, that's star 11 for questions. Our next question will come from the line of Ash Verma from UBS. Your line is open.

Operator: Thank you. Once again, that's star 11 for questions. Our next question will come from the line of Ashwani Verma from UBS. Your line is open.

Operator: Thank you. Once again, that's star 11 for questions. Our next question will come from the line of Ashwani Verma from UBS. Your line is open.

Speaker #5: Hey, good morning. This is Dee calling on behalf of Ash. Just have two sorry if I missed some of the conversation earlier. But I just want to check the FDA remediation.

Dee: Hey, good morning. This is Dee calling on behalf of Ash. Sorry if I missed some of the conversation earlier. I just wanna check, like, the FDA remediation. Just can you briefly outline the remaining steps to file the three pending products by end of Q2, I guess? Like, do you expect, like, a FDA inspection? I think I've heard Robert a bit in the beginning, I wasn't sure it's happening now or is, like what's the status on that? If there's an inspection required, like, are you guys still comfortable with the year-end approval timeline? The second question is just on the, I guess, like, the Q1 temporary production slowdown.

[Analyst] (UBS): Hey, good morning. This is Dee calling on behalf of Ash. Sorry if I missed some of the conversation earlier. I just wanna check, like, the FDA remediation. Just can you briefly outline the remaining steps to file the three pending products by end of Q2, I guess? Like, do you expect, like, a FDA inspection? I think I've heard Robert a bit in the beginning, I wasn't sure it's happening now or is, like what's the status on that? If there's an inspection required, like, are you guys still comfortable with the year-end approval timeline? The second question is just on the, I guess, like, the Q1 temporary production slowdown.

Speaker #5: Just can you briefly outline the remaining steps to file the three pending products by end of Q2, I guess? And do you expect FDA inspection?

Speaker #5: I think I heard Robert in the beginning but I wasn't sure if happening now or it's what's the status on that? And then if there's an inspection required, are you guys still comfortable with the year-end approval timeline?

Speaker #5: And then the second question is just on the, I guess, the 1Q temporary production slowdown. I think that's due to the FDA remediation plan.

Dee: I think that's like due to the FDA re-remediation plan. I just wanna confirm, is that now fully resolved? Is there any risk to like happen again? That's all. Thank you.

[Analyst] (UBS): I think that's like due to the FDA re-remediation plan. I just wanna confirm, is that now fully resolved? Is there any risk to like happen again? That's all. Thank you.

Speaker #5: So I just want to confirm, is that now fully resolved? And then is there any risk to happen again? That's all. Thank you.

Speaker #6: Yeah. Thank you so much, Robert, here. For us, we discussed in my part earlier we basically have a catalyst coming up with, of course, the resubmission and we discussed Entyvio submission and the high-dose Alea.

Robert Wessman: Yeah. Thank you so much. Robert here. As we discussed, in my part earlier, we basically have a catalyst coming up with, of course, the resubmission and we discussed Entyvio submission and the high-dose EYLEA. For us, it's very important that we clear all regulatory risk going forward, if you will. We decided to prolong the slowdown, as I mentioned in my intro, and we see that as a short-term investment to then reap the growth of the launches which are coming, we believe, end of this year and of course, going into 2027. I think I mentioned that we expect to see a strong growth year-on-year, and that's why we want to eliminate any future risk.

Robert Wessman: Yeah. Thank you so much. Robert here. As we discussed, in my part earlier, we basically have a catalyst coming up with, of course, the resubmission and we discussed Entyvio submission and the high-dose EYLEA. For us, it's very important that we clear all regulatory risk going forward, if you will. We decided to prolong the slowdown, as I mentioned in my intro, and we see that as a short-term investment to then reap the growth of the launches which are coming, we believe, end of this year and of course, going into 2027. I think I mentioned that we expect to see a strong growth year-on-year, and that's why we want to eliminate any future risk.

Speaker #6: So for us, it's very important that we clear all regulatory risk on forward, if you will. So we decided to prolong the slowdown, as I mentioned, in my intro.

Speaker #6: And we see that as a short-term investment to then reap the growth of the launches which are coming we believe end of this year and, of course, going into 2027.

Speaker #6: And I think I mentioned that we expect to see strong growth year on year. And that's why we want to eliminate any future risk.

Robert Wessman: I'll leave the rest to Lisa to answer.

Speaker #6: But I'll leave the rest to Lisa to answer.

Robert Wessman: I'll leave the rest to Lisa to answer.

Lisa Graver: Just on the FDA piece. We are in an inspection now, so FDA is on site. It is a routine surveillance inspection that we do expect to close out this week. As Robert noted, we were well-positioned and have been positioning ourselves to respond, and we are on track to respond to the call that was received last year. That will position us in Q2 to resubmit the pending BLAs, and the target is still and does remain Q4. Again, to emphasize, the work that we've been doing since last year through Q1 really is setting us up for that success. We think we will be able to provide further update once the current inspection closes out.

Speaker #5: Yeah. Just on the FDA piece. So we are in an inspection now. So FDA is on site. It is a routine surveillance inspection. That we do expect to close out this week.

Lisa Graver: Just on the FDA piece. We are in an inspection now, so FDA is on site. It is a routine surveillance inspection that we do expect to close out this week. As Robert noted, we were well-positioned and have been positioning ourselves to respond, and we are on track to respond to the call that was received last year. That will position us in Q2 to resubmit the pending BLAs, and the target is still and does remain Q4. Again, to emphasize, the work that we've been doing since last year through Q1 really is setting us up for that success. We think we will be able to provide further update once the current inspection closes out.

Speaker #5: As Robert noted, we were well positioned and have been positioning ourselves to respond. And we are on track to respond. To the Paul that was received last year, that will position us in the second quarter to resubmit the pending BLAs and the target is still and does remain the fourth quarter.

Speaker #5: So again, to emphasize, the work that we've been doing since last year through first quarter really is setting us up for that success. And we think we will be able to provide further update once the current inspection closes out.

Lisa Graver: I think we do anticipate resuming normal operations from a production standpoint this quarter. Again, the underlying fundamental was to remove any further overhang from the CRLs that we received last year, and we think we're gonna be in a great position to do that come this quarter.

Speaker #5: And I think we do anticipate resuming normal operations from a production standpoint this quarter. And again, the underlying fundamental was to remove any further overhang from the CRLs that we received last year.

Lisa Graver: I think we do anticipate resuming normal operations from a production standpoint this quarter. Again, the underlying fundamental was to remove any further overhang from the CRLs that we received last year, and we think we're gonna be in a great position to do that come this quarter.

Speaker #5: And we think we're going to be in a great position to do that come this quarter.

Speaker #7: Awesome. Thank you. Thanks for clarification.

Dee: Awesome. Thank you. Thanks for clarification.

[Analyst] (UBS): Awesome. Thank you. Thanks for clarification.

Speaker #1: Thank you. One moment for our next question. Our next question will come from the line of Arvid Nyckander from DNB Carnegie. Your line is open.

Operator: Thank you. One moment for our next question. Our next question comes from the line of Arvid Nicander from DNB Carnegie. Your line is open.

Operator: Thank you. One moment for our next question. Our next question comes from the line of Arvid Nicander from DNB Carnegie. Your line is open.

Arvid Nicander: Thank you and good afternoon, everyone. Just picking up on what was said previously with SIMLANDI, capturing meaningful market share in Q1, and prescription trends also look pretty supportive for Selarsdi as well, I suppose. Could you just provide a little bit more color here? What has changed commercially to drive this step up when it comes to SIMLANDI uptake this far into the life cycle? If there's anything else that can be said on that. I guess secondly, you mentioned the sort of lag typically seen between partner performance and sales.

Speaker #3: Thank you. And good afternoon, everyone. So just picking up on what was said previously with Simlam, the capturing meaningful market share in Q1, and prescription trends also look pretty supportive for Celarity as well.

Arvid Necander: Thank you and good afternoon, everyone. Just picking up on what was said previously with SIMLANDI, capturing meaningful market share in Q1, and prescription trends also look pretty supportive for Selarsdi as well, I suppose. Could you just provide a little bit more color here? What has changed commercially to drive this step up when it comes to SIMLANDI uptake this far into the life cycle? If there's anything else that can be said on that. I guess secondly, you mentioned the sort of lag typically seen between partner performance and sales.

Speaker #3: I suppose. But could you just provide a little bit more color here? What has changed commercially to drive this step up when it comes to Simlam, the uptick this far into the life cycle?

Speaker #3: If there's anything else that can be said that on that. And then I guess secondly, you mentioned the sort of lag typically seen between partner performance and sales.

Speaker #3: Is this the main explanation why we didn't see a sharper increase in sales in Q1? Or does it also reflect any other dynamics at play when it comes to pricing strategy or any other factors?

Arvid Nicander: Is this the main explanation why we didn't see a sharper, increase in sales in Q1, or does it also reflect any other, dynamics at play, when it comes to pricing strategy or any other factors? I'll start there. Thanks.

Arvid Necander: Is this the main explanation why we didn't see a sharper, increase in sales in Q1, or does it also reflect any other, dynamics at play, when it comes to pricing strategy or any other factors? I'll start there. Thanks.

Speaker #3: I'll start there. Thanks.

Lisa Graver: To address the SIMLANDI uptake. You know, this is really a factor of the continued erosion of the Humira product. We are seeing that exit share of biosims in Q1 being 60%, so that continued growth in terms of the biosimilar market, it's just a larger addressable market that we are, through our partner, Teva, able to take advantage of. I think we've also been, again, through our partner, very execution-oriented in growing that business in terms of taking advantage of both the branded and unbranded market position. I think it's a factor of both, and we're hopeful that we're gonna continue to see that growth certainly through 2026 and beyond.

Speaker #4: To address the Simlandia uptake. So this is really a factor of the continued erosion of the Humira product. So we are seeing that exit share of Biosims in Q1 being 60%.

Lisa Graver: To address the SIMLANDI uptake. You know, this is really a factor of the continued erosion of the Humira product. We are seeing that exit share of biosims in Q1 being 60%, so that continued growth in terms of the biosimilar market, it's just a larger addressable market that we are, through our partner, Teva, able to take advantage of. I think we've also been, again, through our partner, very execution-oriented in growing that business in terms of taking advantage of both the branded and unbranded market position. I think it's a factor of both, and we're hopeful that we're gonna continue to see that growth certainly through 2026 and beyond.

Speaker #4: So that continued growth in terms of the biosimilar market is just a larger addressable market that we are through our partners have able to take advantage of.

Speaker #4: I think we've also been again through our partner very execution-oriented in growing that business in terms of taking advantage of both the branded and unbranded market position.

Speaker #4: So I think it's a factor of both. And we're hopeful that we're going to continue to see that growth certainly through '26 and beyond.

Lisa Graver: In terms of your second question on the contribution from product revenue in Q1, I think we have said in the past, we do see lumpiness in terms of how orders are placed and how product is pulled through in the quarter. We have some degree of control over that, but it is predominantly driven by customer order pattern and invoicing. It is not, from our perspective, a dynamic of pricing at this point. It is really truly order pattern, and we will and do expect to start to see that pick up as we go throughout the remainder of the year.

Speaker #4: In terms of your second question on the contribution from product revenue, in Q1, I think we have said in the past, we do see lumpiness in terms of how orders are placed and how product is pulled through in the quarter.

Lisa Graver: In terms of your second question on the contribution from product revenue in Q1, I think we have said in the past, we do see lumpiness in terms of how orders are placed and how product is pulled through in the quarter. We have some degree of control over that, but it is predominantly driven by customer order pattern and invoicing. It is not, from our perspective, a dynamic of pricing at this point. It is really truly order pattern, and we will and do expect to start to see that pick up as we go throughout the remainder of the year.

Speaker #4: So we have some degree of control over that, but it is predominantly driven by customer order pattern and invoicing. So it is not, from our perspective, a dynamic of pricing at this point.

Speaker #4: It is really truly order patterning. Order pattern. And we will and do expect to start to see that pick up as we go throughout the remainder of the year.

Speaker #3: Great. Thank you so much. Just the last one, if I may, on the foodie partnership. So can you comment anything on what sort of investment commitment this comes with from your side?

Arvid Nicander: Great. Thank you so much. Just the last one, if I may, on the Fuji partnership. Can you comment anything on what sort of investment commitment this comes with from your side? Any guidance on the costs associated with this partnership?

Arvid Necander: Great. Thank you so much. Just the last one, if I may, on the Fuji partnership. Can you comment anything on what sort of investment commitment this comes with from your side? Any guidance on the costs associated with this partnership?

Speaker #3: Any guidance on the costs associated with this partnership?

Speaker #4: Yeah. I think this is something that we touched on as well in the last call. It has been a plan in terms of looking at diversifying our manufacturing capacity, whether it be through further investment internally or externally.

Lisa Graver: Yeah. I think this is something that, you know, we touched on as well on the last call. It has been a plan in terms of looking at diversifying our manufacturing capacity, whether it be, you know, through further investment internally or externally. It is something that was anticipated. I would also say that, because of the nature of this being a tech transfer, we do expect that the batches at the end of the day will be sellable batches, come 2027. It's an investment balanced with the ability to recover that through these sellable batches, when we hit 2027.

Lisa Graver: Yeah. I think this is something that, you know, we touched on as well on the last call. It has been a plan in terms of looking at diversifying our manufacturing capacity, whether it be, you know, through further investment internally or externally. It is something that was anticipated. I would also say that, because of the nature of this being a tech transfer, we do expect that the batches at the end of the day will be sellable batches, come 2027. It's an investment balanced with the ability to recover that through these sellable batches, when we hit 2027.

Speaker #4: So it is something that was anticipated. I would also say that because of the nature of this being a tech transfer, we do expect that the batches at the end of the day will be sellable batches.

Speaker #4: Come '27. So it's an investment balanced with the ability to recover that through these sellable batches. When we hit '27.

Speaker #3: Great. Thank you so much. I'll jump back in the queue.

Arvid Nicander: Great. Thank you so much. I'll jump back in the queue.

Arvid Necander: Great. Thank you so much. I'll jump back in the queue.

Speaker #1: Thank you. Our next question will come as a follow-up from the line of Christopher Uday from SEB. Your line is open. Christopher, your line is open.

Operator: Thank you. Our next question will come as a follow-up from the line of Christopher Uhde from SEB. Your line is open. Christopher, your line is open.

Operator: Thank you. Our next question will come as a follow-up from the line of Christopher Uhde from SEB. Your line is open. Christopher, your line is open.

Speaker #3: Oh, sorry. I was on mute. I was wondering a couple of things. Thanks for the follow-ups. So could you talk a little bit about the impact of reform in Germany and whether that could have a presumably positive impact on your business?

Christopher Uhde: Sorry, I was on mute. I was wondering a couple of things. Thanks for the follow-ups. Could you talk a little bit about the impact of reform in Germany and whether that could have a presumably positive impact on your business? How do you see that evolving as it's implemented? We also heard, I think, during the quarter and in the reports, discussions about the main immunotherapy products and Dupixent loss of exclusivities potentially being extended in comments by manufacturers, for instance. What is your thinking around the, you know, launch timing for those biosimilars? Thank you.

Christopher Uhde: Sorry, I was on mute. I was wondering a couple of things. Thanks for the follow-ups. Could you talk a little bit about the impact of reform in Germany and whether that could have a presumably positive impact on your business? How do you see that evolving as it's implemented? We also heard, I think, during the quarter and in the reports, discussions about the main immunotherapy products and Dupixent loss of exclusivities potentially being extended in comments by manufacturers, for instance. What is your thinking around the, you know, launch timing for those biosimilars? Thank you.

Speaker #3: But how do you see that evolving? As it's implemented? And then we also heard, I think, during the quarter and in the reports, discussions about the main immunotherapy products and Dupixent loss of exclusivity is potentially being extended in comments by a manufacturer's for instance, what is your thinking around the launch timing for those biosimilars?

Speaker #3: Thank you.

Lisa Graver: I think maybe just to address the questions around Dupixent. I think for us, I think it's a little too early for us to comment on, you know, precise launch timings. Certainly it is something that's in our portfolio and we're working towards. I think, you know, from a timing commitment, I think it's a little too early for us to, you know, to put out there our position.

Speaker #4: So I think maybe just to address the questions around Dupixent. So I think for us, I think it's a little too early for us to comment on precise launch timings.

Lisa Graver: I think maybe just to address the questions around Dupixent. I think for us, I think it's a little too early for us to comment on, you know, precise launch timings. Certainly it is something that's in our portfolio and we're working towards. I think, you know, from a timing commitment, I think it's a little too early for us to, you know, to put out there our position.

Speaker #4: Certainly, it is something that's in our portfolio and we're working towards. But I think, from a timing commitment, it's a little too early for us to put out there our position.

Christopher Uhde: Sure.

Christopher Uhde: Sure.

Speaker #3: Sure.

Speaker #4: And maybe just to sorry to go back to the first part of your question on the German reforms. So I think for us, we do think there still could be opportunity and we are certainly seeing today growth, but we do think even if we see a tender market and once we see a tender market form and that's been under discussion obviously for quite some time, in the German market, we do think it will allow for still multiple players.

Lisa Graver: Maybe just sorry, to go back to the first part of your question on the German reforms. I think for us, you know, we do think there still could be opportunity, and we are certainly seeing today growth. We do think, you know, even if we see a tender market and once we see a tender market form, and that's been under discussion, obviously, for quite some time, in the German market, we do think it will allow for still multiple players. We do partner well in Germany. STADA, obviously, is one of our primary partners, who's a very strong player in the market. We think we still have a really good opportunity to position ourselves, even if and when that market starts to transform into a more tender-like market.

Lisa Graver: Maybe just sorry, to go back to the first part of your question on the German reforms. I think for us, you know, we do think there still could be opportunity, and we are certainly seeing today growth. We do think, you know, even if we see a tender market and once we see a tender market form, and that's been under discussion, obviously, for quite some time, in the German market, we do think it will allow for still multiple players. We do partner well in Germany. STADA, obviously, is one of our primary partners, who's a very strong player in the market. We think we still have a really good opportunity to position ourselves, even if and when that market starts to transform into a more tender-like market.

Speaker #4: We do partner well in Germany, Shada obviously is one of our primary partners. Who's a very strong player in the market. So we think we still have a really good opportunity to position ourselves even if and when that market starts to transform into a more tender-like market.

Speaker #4: We do think it will be a multiplayer tender market, not a one. And only market. So I think that does position us well given the strength of our partnerships there.

Lisa Graver: We do think it will be a multiplayer tender market, not a one and only market. I think that does position us well, given the strength of our partnerships there.

Lisa Graver: We do think it will be a multiplayer tender market, not a one and only market. I think that does position us well, given the strength of our partnerships there.

Speaker #3: Thanks. That's very helpful.

Christopher Uhde: Thanks. That's very helpful.

Christopher Uhde: Thanks. That's very helpful.

Speaker #1: Thank you. And I'm not showing any further questions in the queue at this time. I would now like to turn it back over to Benedict for any closing remarks.

Operator: Thank you. I'm not showing any further questions in the queue at this time. I would now like to turn it back over to Benedikt Stefansson for any closing remarks.

Operator: Thank you. I'm not showing any further questions in the queue at this time. I would now like to turn it back over to Benedikt Stefansson for any closing remarks.

Benedikt Stefánsson: On behalf of the team presenting today and all of us at Alvotech, I thank everyone who joined us for this webcast. We look forward to talking to you again and wish you a wonderful rest of the day. Bye-bye.

Speaker #2: So on behalf of the team presenting today and all of us at Alvotech, I thank everyone who joined us for this webcast. We look forward to talking to you again and wish you a wonderful rest of the day.

Benedikt Stefánsson: On behalf of the team presenting today and all of us at Alvotech, I thank everyone who joined us for this webcast. We look forward to talking to you again and wish you a wonderful rest of the day. Bye-bye.

Speaker #2: Bye-bye.

Operator: Thank you for your participation in today's conference. This does conclude the program. You may now disconnect. Everyone, have a great day.

Operator: Thank you for your participation in today's conference. This does conclude the program. You may now disconnect. Everyone, have a great day.

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Q1 2026 Alvotech Earnings Call

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Alvotech

Earnings

Q1 2026 Alvotech Earnings Call

ALVO

Thursday, May 7th, 2026 at 12:00 PM

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