Alvotech (NASDAQ:ALVO) Q1 2026 Earnings Call

0:00 Good day and thank you for standing by. Welcome to the Alvotech First Quarter twenty twenty six Earnings Conference Call. At this time, all participants are in a listen only mode. After the speakers' presentation, we will open up for questions. Please be advised that today's call is being recorded. I would now like to hand it over to our first speaker, Benedict Stephenson, Vice President of Investor Relations. Please go ahead. Thank you, and welcome to our listeners. Yesterday evening, the company issued a press release announcing our financial results for the first quarter of twenty twenty six. 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 twenty twenty six Earnings Call.

1:08 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. Presenting on today's call are Robert Wesman, Founder and Executive Chairman Lisa Graver, Chief Executive Officer and Linda Jornstottir, Chief Financial Officer. Robert will begin today's presentation with a summary of our progress with The U. S. Regulatory pathway and some key business highlights. Lisa will then present a commercial and pipeline update.

1:55 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 Wesman. 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 rest of the world markets. Last week, the FDA began a routine GMP surveillance inspection at our Reykjavik facility, which is currently ongoing.

2:41 Routine surveillance inspection 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 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 enhancement across our quality system and operations. The work to address the findings has been approached in highly structured and disciplined manner and is well advanced.

3:30 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 the first quarter of two thousand twenty six. But I'm very pleased with the progress the organization has made on the resubmission of our biologics license applications for our biosimilars to Symphony, Symphony Aria, Eylea, Prolia, and Taktiva are now in the final stage of completion.

4:27 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 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 Eylea high dose, and there is submission for biosimilar to Eylea, Symphony, Prolia, and Nextiva. These programs target large and growing biologics market and position us with the first wave of biosimilars entrance in their respective segments.

5:21 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. 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-twenty twenty four, marking the transition from an R and D focused organization to commercial biosimilar company.

6:16 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. And with that, I will hand the call over to Lisa. 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 BLA's 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.

7:07 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. As our commercial portfolio and late stage pipeline continue to scale, manufacturing resilience, supply reliability and operational flexibility become increasingly important.

7:52 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 strength of our existing vertically integrated platform. We're in the process of initiating technology transfer activities and expect to begin supplying products for The U. S. Market in the second half of twenty twenty seven 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 the first quarter, we had sales of $106,000,000 and EBITDA of $24,000,000 Both revenues and EBITDA were impacted by the timing of milestones and the slowdown in production related to facility improvements, which reduced product revenues in the quarter.

8:57 We do expect improvement in product revenues as normal operations resume through the second quarter, 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 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 and achieved a 10% market share within the segment. In Europe and other international markets, ABTO2 remains an important contributor to our commercial portfolio.

9:49 We believe there is further opportunity for biosimilar adoption as the overall market continues to grow. For ABTO4, our biosimilar to STELARA, Teva continues to expand STELARA's disease market through formulary and commercial execution, while in Europe, Uspruvo continues to hold a leading share of the biosimilar segment in launch markets. We expect further biosimilar adoption and commercial growth across the ustekinumab market during 2026. For our biosimilars to SYMPHONY, EYLEA, Prolia, and Exjiva, where we received approvals in Europe, UK, and Japan at the end of last year, our partners continue to progress launch activities.

10:36 We remain optimistic on the commercial prospects for these products, particularly for ABT05, the biosimilar to Symphony, which remains the only biosimilar for the predominant presentation in the market. 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.

11:27 Specifically, we are pleased to report that we have submitted a marketing authorization application to the European Medicines Agency for ABT 16 and ABT 80, our proposed biosimilars to Entyvio. Today, sales of Entyvio in Europe are close to $2,000,000,000 and growing. 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.

12:15 In addition, we have enrolled the first patients in a pivotal efficacy and safety study for ABT29 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 8,000,000,000, with 5,000,000,000 in The U. S. And 3,000,000,000 in Europe. 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.

13:07 With that, I hand the call over to Linda to review the financial results in more detail. Thank you, Lisa. I will now take you through the financial results for the first quarter of twenty twenty six. 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 twenty twenty six. Total revenues in the first quarter were $106,000,000 representing a 20% decline compared to the same quarter last year.

13:54 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 twenty twenty six to be the strongest quarter of the year. 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. Product margin in the quarter was 11%. Margins during the second half of twenty twenty five and Q1 twenty twenty six have been impacted by reduced manufacturing throughput associated with facility improvements at the Reykjavik site.

14:43 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 $24,000,000 representing a margin of 23% versus EBITDA of 21,000,000 representing a margin of 15% in Q1 twenty twenty five. 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. As a result, certain development programs now meet the criteria for capitalization under IFRS standard IAS 38 at an earlier stage.

15:39 This has increased the proportion of development costs that are capitalized, and the updated approach has been applied prospectively from the beginning of twenty twenty six. Further on revenues. About half of the revenues in the first quarter of twenty twenty six 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 the first quarter were $51,000,000. The key contributors were our biosimilar to Humira (AVTO2) and our biosimilar to Stellara (AVTO4), our three newly approved products (AVTO3) are biosimilar to Prolia and Akceva, AVTO5, biosimilar to Symphony, and AVTO6, are biosimilar to Eylea, also began contributing incremental product revenues as launches expanded across Europe, The UK and Japan.

16:56 Licensing revenues for the quarter were $55,000,000. 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 $64,000,000 while operating cash flow is negative in the quarter by $25,000,000 driven mostly by working capital. As you can see from the cash flow bridge, other drivers impacting our cash flow in the quarter were: NAFT interest payments of 35,000,000 per quarter, following the transition from PEIC to cash interest mid-twenty twenty five CapEx at 7,000,000 in the quarter and was low in line with plans, investment in untouchables is $39,000,000 in the quarter and we remain focused on achieving positive free cash flow in Q4 twenty twenty six, which continues to be a key financial priority.

18:06 Then 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 $52,000,000 mainly driven by an increase in intangible assets and higher contract assets due to the timing of revenue recognition. Total current assets decreased by $118,000,000 due to collections of trade receivables and reduction in cash to finance operating activities and debt service in the quarter. Next, a few notes on the key movements across equity and liabilities.

18:53 Derivative financial liabilities reduced by $32,000,000 mainly due to fair value changes on conversion futures and earn out shares. Trade and other payables decreased by $28,000,000 due to investments and timing of orders in Q4 twenty twenty five. 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 $650,000,000 to $700,000,000 representing continued double digit growth compared to 2025. Adjusted EBITDA is expected to be in the range of $180,000,000 to $220,000,000 As a reminder, the lower end of our revenue guidance range does not include revenues from the approvals and launches of AVTO3, AVTO5 or AVTO6 in The US.

19:51 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-twenty twenty five. 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 and A.

20:43 Thank you. Our Our first question will come from the line of Christopher Uday from SEB. Your line is open. 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. So is this just ensuring less scope for regulatory commercial disruption from politics and so on?

21:32 How critical was getting this partnership, and should we see it as having a tangible impact on your growth trajectory? And then perhaps you can put that in the context then of the consolidation we've seen during the, I guess, quarter and after within the industry. And then my second question is, so based on your comments, it seems like Cymlandi is taking share in The U. S, looking at Q4 versus now, whereas Rispruvo seems sort of flattish, possibly down somewhat in Europe. What can you tell us about sort of market share position within markets? I mean, it stable or more fluid than overall position? And are there any kind of sort of factors that we can think about that are driving those dynamics?

22:22 Thank you. 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, 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, but I think from a perspective of timing, as we've said, we do expect to introduce product for The US market specifically in the second half of 'twenty seven.

23:17 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 Cimlandi. 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. 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.

24:09 In terms of ustakinumab, particularly in Europe, we are seeing somewhat of a flattening in Q1. I will say we still have three 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. So 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, but certainly we are still seeing that growth.

24:55 So I think from our perspective, growth will continue 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. So optimistic we'll still see some further top line growth there. 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? I mean, is it a majority or is it a minority or any detail you can give there? 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.

25:44 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, but we will continue to look at ways to leverage both the Fuji site as well as our Reykjavik site. Great, thanks so much. I'll get back in queue. Thank you. Our next question will come from the line of Ash Verma from UBS. Your line is open. Hey, good morning. This is Dee calling on behalf of Ash. I just have to sorry if I missed some of the conversation earlier, but I just want to check, like, the FDA remediation.

26:34 Just can you briefly outline the remaining steps to file the three pending products by end of 2Q, I guess? And do you expect an FDA inspection? I think I heard Robert a bit in the beginning, but I wasn't sure it's happening now, or it's like, what's the status on that? And then if there's an inspection required, like, are you guys still comfortable with the year end approval timeline? And then the second question is just on the, I guess, like the 1Q temporary production slowdown. I think that's due to FDA remediation plan. So, I just want to confirm, is that now fully resolved? And then is there any risk to, like, happen again?

27:24 That's all. Thank you. 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 on the we discussed Entyvio submission on the high dose Eylea. So for us, it's very important that we clear all regulatory risk going forward, if you will. So 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 '27.

28:17 And 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 risks. But I leave the rest to Lisa to answer. 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. As Robert noted, we were well positioned and have been positioning ourselves to respond, and we are on track to respond to the poll 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.

29:09 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. 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, and we think we're going be in a great position to do that come this quarter. Awesome. Thank you. Thanks for clarification.

30:01 Thank you. One moment for our next question. Our next question comes from the line of Arvind Nikander from DNB Carnegie. Your line is open. Thank you, and good afternoon, everyone. So just picking up on what was said previously with Synlambi capturing meaningful market share in Q1 and prescription trends also look pretty supportive for Solarisky as well, 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 Simlambi uptake this far into the life cycle? 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.

30:54 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. To address the Cimlandi 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%. So that continued growth in terms of the biosimilar market is just a larger addressable market that we are, through our partner Teva, able to take advantage of.

31:39 I think we've also been, again, through our partner, execution oriented in growing that business in terms of taking advantage of both the branded and unbranded market position. 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. 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, so we have some degree of control over that, but it is predominantly driven by customer order pattern and invoicing.

32:32 So it is not, from our perspective, a dynamic of pricing at this point. It is really truly order pattern, we will and do expect to start to see that pick up as we go throughout the remainder of the year. 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? 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.

33:26 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 come 'twenty seven. So it's an investment balanced with the ability to recover that through these sellable batches when we hit '27. Great. Thank you so much. I'll jump back in the queue. 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.

34:12 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? 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 exclusivities potentially being extended in comments by manufacturers, for instance.

35:00 What is your thinking around the, you know, launch timing for those biosimilars? Thank you. 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. Certainly, it is something that's in our portfolio and we're working towards, but I think, you know, from a timing commitment, I think it's a little too early for us to put out there our position. And maybe just to, sorry, to go back to the first part of your question on the German reforms.

35:54 So I think for us, you know, 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. We do partner well in Germany. Schade 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. 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.

36:49 Thanks. That's very helpful. 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. 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. Goodbye. Thank you for your participation in today's conference. This does conclude the program. You may now disconnect. Everyone, have a great day.