Alvotech (ALVO) Q3 2025 earnings call transcript

Welcome to our listeners. Yesterday evening, the company issued a press release announcing our financial results for the first nine months and third quarter of 2025.

A presentation accompanying today's earnings call was also published under our investor portal, investors. alvotech. com, under news and events. Our press release, presentation, and statements that we make on the call today may include forward-looking statements. Please see our disclaimers on slide number two of the presentation. 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. Presenting on today's call are Robert Westman, Chairman and Chief Executive Officer of Alvotech, Joseph McClellan, Chief Operating Officer, and Linda Jonstotir, Chief Financial Officer. Also with us on the call is Balaji Prasad, Chief Strategy Officer. Robert will begin today's presentation with a discussion of the status of our pending biologics license application with the FDA and facility inspection, and present some business highlights.

Joseph will discuss the status of our development pipeline. Linda will conclude with a discussion of her financial statement and full-year guidance. Following the introductions, our team will be happy to take your questions. And with that, I would like to turn the call over to Robert Westman.

Thank you, Benedict, and thanks to everyone for joining us here today. Please turn to the slide number four in your deck. We are now approaching the end of very eventful year, marked by increased pipeline development, successful product approvals across multiple markets, and growing licensing and products revenues. Alvotech has come a long way in its 12-year history. We have invested approximately $2 billion to build a global pure-play by a similar company with integrated R&D and manufacturing under one roof. We commercialized globally through a network of nearly 20 partners, reaching over 90 countries worldwide. After launching our first biosimilars in 2022 and second biosimilar in 2024, we entered the US market last year. The 2024 global launches drove a 420% revenue growth in that year, and we are guiding approximately 20% growth for 2025.

Five, with exclusivity expiring on dozens of originated biologics each year, and regulators waiving costly efficacy trials, the biosimilar market is set for explosive growth. With resources and strong focus on developing and manufacturing biosimilars, Alvotech is well positioned to lead the charts. In fact, we proactively responded to anticipated changes in regulatory guidelines by expanding our research and development initiatives approximately two years ago.

More recently, we have further enhanced our R&D capabilities with the establishment of an operational base in Sweden. The result is already evident in our growing pipeline, five approved biosimilars, twelve other disclosed development programs, and already developed sell lines for additional 15 valuable targets, in total targeting greater than $185 billion of originator markets.

Now, let me touch upon a few key points that I will discuss today and described on the following slide. This includes an update on the FDA process, our pipeline, a comment on the revised outlook for the year, and an update on our marketed products. So, let's turn to the next slide. As announced last week, we received a complete response letter, or CRL, from the FDA for our BLA for the proposed by a similar to Symphony. The sole reason noted in the CRL concerns unresolved issues identified by FDA during the inspection of our Reykjavík facility, which concluded in July of this year. Let me make it clear. This CRL did not change the status of Reykjavik manufacturing facility, which continues to be an FDA-approved site that produce and will continue to produce our current marketed products in the US.

Also, the site is approved to manufacture for global markets and continues to get approvals for our new product launches. The facilities referenced in our regulatory application, including our Reykjavík site, are of course regularly inspected by several global regulatory agencies as a routine part of the review process. For example, both the European Medicine Agency and Japan's PMPA inspected our Reykjavík site earlier this year in support of our new product approvals in these markets that will occur in third and fourth quarter. Leveraging several successful inspections by many regulatory authorities, including recent inspection by FDA in third quarter of 2024, which yielded only two minor Form 483 observations, we remain committed to continuous improvement of our manufacturing operations.

To support consistent and effective leadership at the site, we have expanded the responsibility of Joseph McLellan, current Chief Scientific Officer, by appointing him as Chief Operating Officer. In his role, Joseph will be responsible for technical operation as well as resource and development, supply chain, and project management. Before joining Alvotech in 2019, Joseph held positions of increased responsibility at Wyatt and Pfizer in the United States over a span of 17 years. During his tenure at Alvotech, he has played a key role in advancing and strengthening our high-performing research and development organization and its pipeline. His commitment to uphold best-in-class quality standards and operational excellence will position Alvotech to address any concerns raised by FDA at our facility.

Although we are disappointed by the approval delay resulting from the CRL, we remain committed to promptly resolve any outstanding matter relating to the facility. Once FDA provides clarity later this month on the specific issue identified during the inspection, we will address those in timely manner. Once we respond to the CRL, we anticipate the approval of our BLA may be granted as early as the first half of 2026, in accordance with six months statutory review periods. With this review timing, we still anticipate being one of the first, if not the only, approved by a similar to Symphony in US and other global markets. Of note, we have already received approval in Japan and UK, with EMA approval expected shortly for our biosimilar to Symphony.

So please turn to the next slide addressing our revenue growth. Later in the call, Linda will discuss our third quarter financial results and full year guidance in details. When we reported our full-year guidance in March, we signaled that the first half and second half of the year would be relatively balanced, while the fourth quarter would be the strongest of the year due to anticipated product approvals and launches which were occurring later in the year. Following the receipt of CRL from FDA, we revised our outlook for full year to 570 million to 600 million top-line revenues and adjusted EBITDA of $130 to $150 million. We believe the cost incurred and temporary loss in product revenue, a necessary investment in our future growth, and will make the company stronger as we continue to expand our portfolio of products and lumps into additional global markets.

As you can see on this slide, Alvotech's revenue growth has been extraordinary, or 127%, on average per year from 2021 to year 2024. With the latest guidance we have given, we are projecting a compounded average growth rate of 94% from 2021 till end of this year. As we are launching three more biosimilar days here, this contributes to both licensing and product revenues, and our strong pipeline and increased R&D will allow license revenues to continue to be a significant revenue contributor. We are very pleased to say that we are seeing very strong global interest in our enhanced product portfolio. We continue to sign numerous contracts with our partners globally which will continue to deliver strong milestone revenues and secure the strong market share globally going forward So please turn to the next slide Now I will turn to how the markets for the existing products have evolved In the US, we continue to hold the second largest market share in the QMira biosimilar segment, and our products remain the fastest growing QMira biosimilar.

The originator's share is eroding and expected to fall below 50% of its original volume by year-end, with most volume continuing to shift to biosimilars and much smaller portion transitioning to novel therapies. In Europe, our partners data continues to grow volumes for Hugh Kindra. We have seen average quarter on quarter growth of 12% the last four quarters. Jukindra now holds the top position in several of the 10 largest EU markets, including Austria and Sweden, and has reached 10% share in France, competing against nine other biosimilars. In Canada, simlandi marketed with Jump Pharma remains the fastest growing Humira biosimilar. With respect to our biosimilar to Stellar in the US, our partner TEFA continues to secure formulary coverage, and we are among the top three biosimilars on the market for this reference product.

In Europe, we were first to launch Stellara Biosimilar, and while the competition has increased, we are still holding a leading position in the European markets where we have launched our product, with about 10% share of the total Stellara market and 25% share of the Biosimilar segment. We expect 50% of Stellar's European market to transition to biosimilars by year-end.

With that, I will hand the call over to Joseph McLellan, who will discuss our portfolio, including the near-term launches. So, over to you, Joseph.

Thank you, Robert. As described on the next slide, our products, AVTO6, a bio similar to ILEA, AVTO5, a bio similar to Symphony, and AVTO3, a bio similar to the dual products of Prolia and Xchiva, are scheduled for launch in Europe this quarter.

AVTO6 has received approval in Japan, the UK, and the European Economic Area. Last week, the UK High Court rejected Regeneron's and Bayer's request to stop Alvotech's manufacturing of its ILEA biosimilar in the UK. This ruling enables us to manufacture in anticipation of commercial launches after the ILEA supplementary protection certificates expire on November 23rd of this year. We are prepared to launch AVTO6 pre-filled syringes and vials across Europe post-expire of exclusivity and look forward to entering the market with strong partners.

AVTO5 has already received approval in Japan and the UK, and we are expecting a favorable decision from the European Commission for the EEA in the later part of November, following the EMA's CHMP recommendation early this summer. We intend to proceed with the launch properly after approval, anticipate being the sole bow similar to sympathy available on the European market for several months. In Japan, we have secured the necessary rights and plan to initiate launch activities during the first half of 2026. For AVTO3, which has been approved in Japan, European Commission approval for the EEA is anticipated in the second half of November, following EMA's CHMP recommendation this summer. The intention is to ship launch supplies to our commercial partners in Europe during this quarter.

It is expected that AVTO3 will be among the first products available, with established partners supporting its market introduction. Turning to our development pipeline on the next slide, we are pleased to report ongoing growth and advancement across our programs. In collaboration with partners Kashiv and Advance, we have submitted a biosimilar candidate to Zolaire in the EEA and previously filed for approval in the UK, where the review process is ongoing. The development of AVT29, a biosimilar candidate to high-dose ALEA, as well as AVT16 and 80, a biosimilar to intibio for both intravenous and subcutaneous administration, is proceeding towards regulatory submissions targeted for 2026. Progress continues on our candidate to Keytruda in partnership with Dr. Reddy's, including completion of manufacturing for clinical supplies.

Additionally, we have initiated clinical manufacturing for our candidate to Simzia, with positive developments underway. Our investment in the early-stage pipeline remains strong. Today, we are announcing two new molecules, biosimilar candidates to Hemlibra and MFINZ, which are currently in process development. Further, we have over 15 cell lines completed for future development within our expanding portfolio. At this point, I invite Linda to deliver the financial overview.

Thank you, Joe, and good day to everyone who has joined us on the call today. Today, I will take you through the financials for Q3 and the first nine months of 2025. The earnings stack is more detailed than usual, and we hope you appreciate the additional insights into the quarterly results provided in the next few slides. As Robert mentioned, Alvotech has delivered strong CAGR growth in the past four years since launching our first Biasimilar, and there is continued momentum and demand appetite for our on-market products of Biasimilars to Humira and Stellara.

Turning to the next slide, which highlights our Q3 financial performance. As we communicated as part of our Q2 results, we were expecting Q3 to be a soft quarter followed by a strong Q4. This was primarily driven by lower product revenues and product margins, which were impacted by the timing of orders, portfolio mix, and temporary loss in product revenues related to facility improvements, as Robert noted earlier.

In Q3, licensing revenues were at a high level of 81 million, supporting a strong gross margin of 69%. We also finalized the integration of Ivers Lee into our financials that were acquired in July. Hi, Iversley is a Swiss-based assembly and packaging service provider and will increase our capacity for finished product assembly and packaging. At yesterday, there was 14 million or 13% of revenues and was impacted during the quarter by costs associated with improvements in operations to support new launches. Operating cash flow is then a function of our revenue collections in the quarter, down from a very strong quarter in the second quarter of 25, and outflow driven by inventory built in support for upcoming launches.

And looking at the year to date on the next slide, Alvotech delivered total revenues of $420 million for the first nine months, which represents strong 24% growth year on year. This shows our strong commercial momentum following the launch of our biosimilar to Humira in the US and early traction for our biosimilar to Stellara in both Europe and the US.

Gross margin was at 59% and underscores the strength of our licensing model, while product margin of 27% reflects quarter three softness. Adjusted EBITDA in the first nine months was 68 million, or 16% margin. When compared to prior year, it is important to note that 2024 included very high licensing revenues tied to three biosimilar submissions and the U. S. launch of our biosimilar to Humira, along with the launch of our biosimilar to Stellar and Europe. Cash balance at the end of September was $43 million and reflects outflows connected to inventory build-up ahead of product launches, CAPEX investments, and M&A activity. If we then double-click on the revenue and EBITDA trends on the next slide, our revenue model as a B2B company naturally leads to quarterly fluctuations related to timing of orders from our partners.

However, despite these fluctuations, we delivered strong double-digit growth in revenues both in the quarter and in the first nine months, up 11% and 24% respectively, with a trailing 12-month run rate of $571 million in revenues. A just a dbita margin for the first nine months 2025, however, was at 16% compared to 26% last year. This was driven by higher R&D investments to accelerate pipeline expansion, as well as higher DNA costs to scale operations and infrastructure to be able to drive operational efficiency across the organization.

Finally, I would like to highlight that we continue to diversify geographically with growing contributions from Europe as markets here in Europe and other markets outside of the U. S. continues to grow.

Moving to cash flow on the next slide. As I touched on earlier, cash flow in the quarter was a function of lower revenue collection due to timing and planned inventory buildup in support of upcoming launches. We also continued strategic investments in CAPACs and in Tundibol to expand capacity to support new launches and our growth plans. New working capital option of $100 million will be used to capture swings in working capital.

CAS is impacted by the cost associated with acquisition of Iversley and interest payment since from June 25 we are paying CAS interest on our loans. Next, I would like to quickly touch on the balance sheet on the next two slides. Our asset space remains strong, supported by recent Bolton acquisitions, and continued investment in R&D to drive future growth.

Current assets are stable overall, with expected shifts in inventory and trade receivables during the period. Looking into the equity and liability side, a couple of things to mention here. In addition, our equity position strengthened by $236 million, driven by profit for the period, and the inflow of capital contributions from our recent sweetest listing. Derivative financial liabilities decreased by million mainly due to fair value chains on earn shares And lastly the overall contract liabilities decreased due to recognition of licensing revenues If we then turn to the next slide, featuring our revised full-year outlook. On November 4th, we revised our outlook following the CRL from the FDA. Today, we updated our outlook for the full year to a range of $570 million to $600 million in revenues and adjusted EBITDA range of $130 million to $150 million.

This revision reflects action taken to respond to any issues identified by the FDA inspection impacting production efficiency in 2025. Some of the licensing agreements for pipeline assets that were expected at the end of Q4 are now shifting to 2026. Despite these short-term headwinds, we expect a strong finish to the year, especially with licensing revenues that translate directly to EBITDA.

At the midpoint of the guidance, we are targeting to deliver 19% year-on-year revenue growth and 30% EBITDA growth. Fundamentals remain strong. We expect margin recovery and accelerated revenue contribution will follow new launches and continued geographical diversification. More importantly, we continue to see growth in markets outside the U. S. , which helps balance our revenue profile. Based on the committed orders we have for our new launches in markets outside the U. S. , combined with the growth momentum we are seeing with our currently marketed products, We are well positioned to deliver top-line and debita growth in 2026. Management will provide new future guidance no later than with the Q4 25 results.

Our strategic focus for the next 18 months is on focused execution to unlock long-term growth, advancing the pipeline, realizing multiple global launches to deliver solid sales growth and diversification of revenues across geographies and products. At the same time, we will drive cost optimization and operational efficiencies to support margin expansion. Working capital management will also be our key focus to achieve positive free cash flow and support our growth trajectory. This brings me to my final slide. I think it's always good to look a bit backwards and see where we're coming from, where we are today, and where are we heading.

Alvotech's journey from its 2013 foundation to today reflects the transformation into a leading biotech company with one of the industry's most valuable biosimilar pipelines. From 2013 to 2023, the focus was on building a vertically integrated platform, investing in R&D and talent, and establishing global partnerships to enable successful launches of Humira and Stellara biosimilars. The 2024-2025 period marks a major inflection point, multiple global approvals, including those referencing Humira and Stellara in the U. S. , accelerated pipeline development, and five-fold revenue growth from 2023-2024.

We achieved positive EBITDA in 2024 and are targeting around 30% growth in 2025 on EBITDA level. Looking ahead to 2026, our priorities are diversification and scale, advancing our pipeline, executing multiple global losses, and critically adhering to regulatory standards and ensuring FTA compliance as a cornerstone of success. With a 20 billion addressable market for upcoming biosimilars, we are positioned to deliver sustainable growth and long-term shareholder value.

I will now turn the call back over to the operator for Q&A.

This is Joe McClellan, Chief Operating Officer for Alvotech. We have been in a situation where we have done a significant number of improvements since the inspection has concluded. The observations were no repeat observations. I'm going to say that clearly. There were no repeat observations in the deficiencies identified in the Form 483 from the FDA at the conclusion of the inspection. And so it's a number of things that we have to improve about the facility associated with some of our aspects associated with manufacturing, control of our facility, documentation, investigations. We have committed to the FDA to complete more than 180 different changes to address all of their observations, plus more, so that we will not be in the situation again.

In doing this, we have now completed 93% of these commitments, and we have communicated them to the FDA. We're in the process of completing additional actions that we will continue to keep the FDA updated on.

Yeah, thank you for the question, Robert Westman here, CEO. Overall, I mean, the concept and the vision and the strategy around the business is to keep everything in-house, both R&D and manufacturing. We think creating a platform like we have is extremely important. We can say that in the US we are around 80 months into being a commercial company, if you will. We have gone through three FT inspections over the 18 months. And the first two, which was early 24, was only one 483. And then late last year, we had a general GMP inspection, which we only got two minor 483s. So overall, I would say it was very disappointing to get this CRL and unexpected.

But the company has continued to grow and strengthen further the quality systems. And we have full intention to absolutely stay and be best in class when it comes to GMP and quality. And I mean, that's reflected. We have gone through successfully five EMA inspections. We have gone through at least four inspections from different global health authorities and now two successful FDA inspections. So as Joe explained in details, we took this very seriously, and I think overall we have done substantial improvements. And Joseph himself has shown an amazing success in R&D and brought all of our five currently approved or marketed products to a success.

And the 12 products which are in late stage in R&D. And he has extensive experience, as I mentioned in my part from Pfizer, and he lives in Iceland. And that is a big factor to have the core team living in Iceland to take charge. And I have great expectations with those changes that all future deficiencies hopefully will be behind this. But saying that, of course, we are in pharmaceuticals. We are seeing that companies, whether it is big pharma or biotech or biosimilars or small molecules, there are unfortunately FTAs, 483s, or even CRLs coming up on a very regular basis. So it's a kind of moving target, and we will continue to move with it, if you will.

Yeah, I think it's a very appreciated question, if you will. I mean, we continue to see a very strong interest in our products. I mean, we definitely have the broadest portfolio of all biosimilar companies in the industry, and that is our strength. But this of interest of course leave aside 11 12 successful inspections from EMA to US FDA to other health authorities in the world Our clients are doing also inspections or audit on ourselves So our customers are very much aware of the status of the facility and overall we have not seen any reduction of interest in our products and we keep our key clients up to date.

Okay, it's Linda Iosotie here, CFO. If I understood your question correctly, it's about the change in guidance that we announced on November 4th. I would say it's twofold. The revision is about actions taken to respond to any issue, so that is slowing us down on the production side and impacting our revenues in 2025. But we are also seeing some of the licensing agreements for pipeline assets that were expected at the end of Q4 are now shifting to 2026.

That's just like a timing impact, but has sizable EBITDA impact in Q4, since it's like licensing revenues that flows directly into EBITDA. However, if I also comment a bit on 2026 and our comfort levels there, if I look into the committed orders we have for new launches and markets outside of the US, and in a combination with growth momentum noted in currently marketed products, we are in a very good position to deliver top-line and EBITDA growth in 2026.

No, I think, Robert, here again, I think we have a pretty clear visibility on that, and the drug product part of the facility is undergoing some minor adjustments as we speak, and we will then close the drug substance for a particular period in December for both general maintenance and adjustment. So I think we, as Linda said, we have most of the orders which are in the order book to be delivered the end of this year produced. They still need to be, some of them are assembled or packed, but mostly they have been produced. And we have a good, pretty good visibility how the year ends, we believe, and comfort level, how that will end. And as you can imagine, based on the guidance we gave and based on year-to-date debita, it's fairly easy to see how strong the workforce will be.

And it's a good, as Linda said, good momentum with all the books. So based on what we are seeing, we are fairly confident on growth both top line and EBITDA for 26, no matter what.

Okay, if I continue, we will, so as I was saying, observations around putting in manufacturing controls, improving the way you do investigations, laboratory controls, documentation practices, those kinds of aspects. So we committed to doing over 180 different actions to the FDA, things such as ensuring that we have the microbial controls by putting measures in to prevent actions that could be considered. Because it's clear that the FDA made observations, for example, around our manufacturing controls that may lead to lack of sterility, but not that actually it was observed, right? So we did things to then strengthen that, putting practices in terms of how we do, say, for example, visual inspection, how we make sure that our airflow is correct, to make sure that our procedures associated with changing and gowning are all improved, right?

So we did all of those improvements over the last few months since the 4th of July. Since then, we have begun manufacturing. The product that we are delivering in the fourth quarter is product that has been manufactured in both the third and the fourth quarter. So there are actions progressing. We are manufacturing. As Robert says, there's always going to be the need for minor actions for maintenance. Those things are taken into account, and we make sure that we improve those. But in general, we are manufacturing and delivering product for this quarter that we have recently manufactured since the slowdown we referenced in the press release.

Linda? Yeah, and to touch on your cost question, like on the R&D side, we had elevated levels on R&D both in Q2 and in Q3. That's also related to timing of clinical and manufacturing activities as well as launch preparation for our upcoming launches. In Q3, we also had impact in R&D related to the improvement that Joe was covering. We are expecting that also to touch our R&D numbers in NQ4, but I can confirm that we're still expecting lower R&D in NQ4 than both NQ2 and NQ3.

Yeah, Robert Westman here again. I will hand this over to Joseph, but I just want to say and underline. So we anticipated this change over two years ago. And based on that, we changed our approach to R&D, if you will. And as we have already stated on this call and the previous calls, we have all in all between marketed products, approved products, late stage development, early stage development, over 30 products in the pipeline. So we think we have used the time very well and taking advantage of the changes which are coming now by kind of assuming and expecting this to come. So we are already, you know, bearing the fruits of that vision we had back in time.

But for the detailed answers, maybe Joe, if you take that.

Yeah, absolutely. So this is Joseph. For sure, right, we are doubling down on our strategy. You know, we have a proven development engine. We are leveraging that. We, as Robert said, we forecasted and anticipated that the need to do patient efficacy studies was going to go away from a regulatory perspective. It has. And because we made the bets over two years ago, we are now in a good position to take advantage of that. And we are doing that for products as we're developing them, right? So you can imagine that, yes, Cymzia would be one of those as well.

Yes, thank you. So on behalf of the Alvotech team, I would like to thank everyone who called in and listened to our call today. And we look forward to speaking with you again and wish you a good rest of the day. Thank you. Thank you.