- Alvotech announces completion of FDA surveillance inspection at Reykjavik facility
May 11, 2026
Alvotech
Company remains on track for BLA resubmissions in the second quarter
REYKJAVIK, ICELAND – May 11, 2026 – Alvotech (NASDAQ: ALVO; ALVO-SDB), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announces that the U.S. Food and Drug Administration (FDA) has completed a routine cGMP surveillance inspection of the company’s manufacturing facility in Reykjavik, Iceland.
At the conclusion of the inspection on May 8, 2026, the FDA issued a Form 483. The company believes the observations can be addressed quickly and do not raise any substantial issues with the site or its operations.
Based on the outcome of the inspection, Alvotech is well positioned to resubmit the relevant Biologics License Applications this quarter, once the final data have been compiled.
More importantly, the company believes the outcome of this inspection demonstrates the strong cGMP fundamentals of the site and the robustness of all the improvements the company has implemented since last year.
Alvotech continues to expect FDA approval for the relevant BLAs during 2026.
For further information, contact:
Media
Benedikt Stefansson
Sarah MacLeod
alvotech.media@alvotech.com
Investors
Dr. Balaji V Prasad
Benedikt Stefansson
alvotech.ir@alvotech.com
About Alvotech
Alvotech is a biotechnology company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in biosimilars by delivering high-quality, cost-effective products and services, enabled by a fully integrated approach and broad in-house capabilities. Five biosimilars are already approved and marketed in multiple global markets, including biosimilars to Humira® (adalimumab), Stelara® (ustekinumab), Simponi® (golimumab), Eylea® (aflibercept) and Prolia®/Xgeva® (denosumab). The current development pipeline includes nine disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. For more information, please visit https://www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release.
For more information, please visit our investor portal, and our website or follow us on social media on LinkedIn, Facebook, Instagram and YouTube.
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Alvotech Forward Looking Statements
Certain statements in this communication may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements include, for example, Alvotech’s expectations regarding competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, regulatory submissions, review and interactions, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, market launches and financial projections. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Alvotech’s control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to factors set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that Alvotech may from time-to-time file or furnish with the SEC. There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Alvotech does not undertake any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication. Alvotech disclaims any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed.
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- Alvotech Announces Completion of FDA Surveillance Inspection at Reykjavik Facility
May 11, 2026 · globenewswire.com
- Company remains on track for BLA resubmissions in the second quarter REYKJAVIK, Iceland, May 11, 2026 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO; ALVO-SDB), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announces that the U.S. Food and Drug Administration (FDA) has completed a routine cGMP surveillance inspection of the company's manufacturing facility in Reykjavik, Iceland. At the conclusion of the inspection on May 8, 2026, the FDA issued a Form 483.
- ALVOTECH ANNOUNCES COMPLETION OF FDA SURVEILLANCE INSPECTION AT REYKJAVIK FACILITY
May 11, 2026
- COMPANY REMAINS ON TRACK FOR BLA RESUBMISSIONS IN THE SECOND QUARTER REYKJAVIK, ICELAND, MAY 11, 2026 (GLOBE NEWSWIRE) -- ALVOTECH (NASDAQ: ALVO; ALVO-SDB), A GLOBAL BIOTECHNOLOGY COMPANY SPECIALIZING IN THE DEVELOPMENT AND MANUFACTURE OF BIOSIMILAR MEDICINES FOR PATIENTS WORLDWIDE, TODAY ANNOUNCES THAT THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) HAS COMPLETED A ROUTINE CGMP SURVEILLANCE INSPECTION OF THE COMPANY'S MANUFACTURING FACILITY IN REYKJAVIK, ICELAND. AT THE CONCLUSION OF THE INSPECTION ON MAY 8, 2026, THE FDA ISSUED A FORM 483.
- Alvotech (ALVO) Q1 2026 Earnings Transcript
May 8, 2026
Image source: The Motley Fool.
DATE
Thursday, May 7, 2026 at 8 a.m. ET
CALL PARTICIPANTS
Executive Chairman — Robert Wessman Chief Executive Officer — Lisa Graver Chief Financial Officer — Linda Jonsdottir Chief Legal and IR Officer — Benedikt Stefansson
Full Conference Call Transcript
Robert Wessman: 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. 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 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 operations. The work to address the findings has been approached in a highly structured and disciplined manner and is well advanced. Importantly, we have deliberately taken additional time to substantially derisk 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 support 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 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 Simponi, Simponi Eylea, Prolia and Xgeva are now in the final stage of completion. 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 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 strength 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 U.S. market in mid-2024, marking the transition from an R&D-focused organization to a global commercial biosimilar company.
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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.
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 BLA is 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 U.S.-based manufacturing capability. 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 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 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 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, 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. 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 U.S. 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.
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 launch markets. We expect further biosimilar adoption and commercial growth across the ustekinumab market during 2026. For our biosimilars to Symphony, Eylea, Prolia and Xgeva, where we received approvals in Europe, U.K. 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 a 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.
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. 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 U.S. in 2028. With this, we believe we could be the first to submit a biosimilar to high-dose Eylea in Europe and the U.S. Today, the combined low-dose and high-dose market for Eylea is approximately $8 billion, with $5 billion in the U.S. and $3 billion 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. With that, I hand the call over to Linda to review the financial results in more detail.
Linda Jonsdottir: 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. 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 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.
Gross margin for the first quarter was 57%, an improvement of 6 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 2025 and Q1 '26 have been impacted by reduced manufacturing throughput associated with facility improvements at our Reykjavik site. 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, 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. As a result, certain development programs now meet the criteria for capitalization under IFRS under 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 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. 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. The key contributors were our biosimilar to Humira, AVT02 and the biosimilar to Stelara, AVT04. Our three newly approved products, AVT03 are biosimilar to Prolia and Xgeva, AVT05 are biosimilar to Simponi and AVT06 or biosimilar to Eylea also began contributing incremental product revenues as launches expanded across Europe, the U.K. 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, CapEx at $7 million in the quarter and was low in line with plans.
Investment in intangibles 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. 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 million, mainly driven by an increase in intangible assets and higher contract assets due to the timing of revenue recognition.
Total current assets decreased by $118 million 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. 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 million to $700 million, representing continued double-digit growth compared to 2025.
Adjusted EBITDA is expected to be in the range of $180 million 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 U.S. 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 improvement 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.
Operator:[Operator Instructions] Our first question will come from the line of Christopher Uhde from SEB.
Christopher Uhde: 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? 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 in -- during the, I guess, quarter and after within the industry? And then my second question is, so based on your comments, it seems like Simlandi is taking share in the U.S. looking at Q4 versus now, whereas Uzpruvo seems sort of flattish, possibly down somewhat in Europe.
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 kind of sort of factors that we can think about that are driving those dynamics?
Lisa Graver: 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 U.S. market specifically in the second half of '27. 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 U.S. 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 U.S. 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. In terms of ustekinumab, 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 U.S. It's sitting at about 56% at biosimilar 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. So, I think from our perspective, growth will continue in the U.S. 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.
Christopher Uhde: Just a clarification on the first one. What sort of proportion of your U.S. 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?
Lisa Graver: Yes. 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. 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.
Operator:[Operator Instructions] Our next question will come from the line of Ash Verma from UBS.
Di Zhao: This is Di 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. Just can you briefly outline the remaining steps to file the three pending products by end of 2Q, I guess? And do you expect like the FDA inspection? I think I heard Robert in the beginning, but I wasn't sure it's happening now. Or 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 time line? And then the second question is just on the, I guess, like the 1Q temporary production slowdown.
I think that's like due to the FDA remediation plan. So I just want to confirm, is that now fully resolved? And then is there any risk to happen again? That's all.
Robert Wessman: Yes. 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 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. 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 risk.
But I'll leave the rest to Lisa to answer.
Lisa Graver: Yes. 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 call 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.
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 to be in a great position to do that come this quarter.
Operator: Our next question comes from the line of Arvid Necander from DNB Carnegie.
Arvid Necander: So just picking up on what we said previously with Simlandi capturing meaningful market share in Q1 and prescription trends also look pretty supportive for Selarsdi 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 Simlandi uptake this far into the life cycle? If there's anything else that can be said on that? And then I guess, secondly, you mentioned the sort of lag typically seen between partner performance and sales. 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.
Lisa Graver: To address the Simlandi uptake. So this is really a factor of the continued erosion of the Humira product. So we are seeing that exit share of biosimilars 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 partners have 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. 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. So 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.
Arvid Necander: Great. Just the last one, if I may, on the Fuji partnership. So, 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?
Lisa Graver: Yes. I think this is something that 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 through further investment internally or externally. 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 '27. So it's an investment balanced with the ability to recover that through these sellable batches when we hit '27.
Operator: Our next question will come as a follow-up from the line of Christopher Uhde from SEB.
Christopher Uhde: I was wondering a couple of things. 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. 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. What is your thinking around the launch timing for those biosimilars?
Lisa Graver: So I think maybe just to address the questions around Dupixent. So I think for us, 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 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.
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. We do partner well in Germany. STADA, 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.
Operator: And I'm not showing any further questions in the queue at this time. I would now like to turn it back over to Benedikt for any closing remarks.
Benedikt Stefansson: 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.
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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- Alvotech’s Earnings Swing And Counsel Exit Might Change The Case For Investing In ALVO
May 8, 2026
Alvotech has reported past first-quarter 2026 earnings, with net income of US$1.03 million compared with US$109.68 million a year earlier, and confirmed the planned departure of long-serving General Counsel Tanya Zharov. The sharp year-on-year swing in net income and a leadership transition in the legal function together raise fresh questions about earnings quality, governance continuity and how the biosimilar pipeline is being supported. Next, we’ll examine how this sharp year-on-year net income change could influence Alvotech’s existing investment narrative around biosimilar execution.
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Alvotech Investment Narrative Recap
To own Alvotech, you largely need to believe that its biosimilar portfolio and partnerships can eventually translate into more consistent earnings, despite current volatility. The sharp drop in first quarter 2026 net income to US$1.03 million from US$109.68 million, combined with the planned departure of long-serving General Counsel Tanya Zharov, adds near term uncertainty around earnings quality and governance, but does not obviously change the core near term catalyst around execution of key biosimilar launches and approvals.
The most relevant recent announcement is Alvotech’s reaffirmation on 18 March 2026 of its revenue guidance of US$650 million to US$700 million for 2026, with a focus on cash flow and margin expansion. Against the latest small quarterly profit and a major legal leadership transition, that guidance now looks more exposed to timing of milestone payments, regulatory events and partner performance, making the existing catalyst around pipeline delivery more tightly linked to the company’s ability to manage earnings volatility.
Yet beneath the promise of a growing biosimilar footprint, investors should also be aware of how dependent Alvotech remains on lumpy milestone revenue and...
Read the full narrative on Alvotech (it's free!)
Alvotech's narrative projects $980.5 million revenue and $189.6 million earnings by 2029. This requires 18.5% yearly revenue growth and about a $161.7 million earnings increase from $27.9 million today.
Uncover how Alvotech's forecasts yield a $14.00 fair value, a 338% upside to its current price.
Exploring Other PerspectivesALVO 1-Year Stock Price Chart
Before this news, the most pessimistic analysts were already flagging regulatory timing and partner risk, even while assuming revenue could reach about US$950.6 million and earnings US$87.5 million by 2029, so you should expect that views on Alvotech’s path from here may shift further and consider how differently others might frame that risk.
Story Continues
Explore 5 other fair value estimates on Alvotech - why the stock might be a potential multi-bagger!
Decide For Yourself
Disagree with existing narratives? Extraordinary investment returns rarely come from following the herd, so go with your instincts.
A great starting point for your Alvotech research is our analysis highlighting 3 key rewards and 2 important warning signs that could impact your investment decision. Our free Alvotech research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate Alvotech's overall financial health at a glance.
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This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.
Companies discussed in this article include ALVO.
Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team@simplywallst.com
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- Alvotech (ALVO) Q1 2026 Earnings Call Transcript
May 7, 2026 · seekingalpha.com
Alvotech (ALVO) Q1 2026 Earnings Call Transcript
- Alvotech Q1 Earnings Call Highlights
May 7, 2026
Alvotech logo
Key Points
FDA inspection at Alvotech’s Reykjavik facility is underway and Biologics License Application resubmissions for multiple biosimilars are in the final stage, with the company planning resubmissions in Q2 and targeting Q4 approvals. Facility quality improvements have reduced manufacturing throughput, and Alvotech signed a deal with Fujifilm to add U.S. capacity; technology transfer is underway with product supply to the U.S. expected in the second half of 2027. Commercially, AVT02 (Humira biosimilar) is the fastest-growing U.S. Humira biosimilar at about 10% of the biosimilar segment, while Q1 revenue fell 20% to $106 million; management reaffirmed full-year revenue guidance of $650–$700M and adjusted EBITDA guidance of $180–$220M. Interested in Alvotech? Here are five stocks we like better.
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Alvotech (NASDAQ:ALVO) executives said the company’s first-quarter priorities centered on advancing U.S. regulatory work, maintaining inspection readiness, and expanding commercial activity globally as the biosimilar developer works through manufacturing enhancements at its Reykjavik facility.
FDA inspection underway; resubmissions nearing completion
Founder and Executive Chairman Róbert Wessman said the company spent the quarter “progressing the FDA resubmission, maintaining a high level of inspection readiness, and continuing to expand our commercial business globally.” He noted the U.S. Food and Drug Administration began a “routine GMP surveillance inspection” at Alvotech’s Reykjavik facility last week, with the inspection “currently ongoing.” Wessman said the company expects it to conclude “by the end of business day tomorrow,” adding that routine surveillance inspections are a normal part of operating an FDA-regulated manufacturing site.
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Wessman also referenced steps taken since the company’s most recent pre-license inspection in July 2025. He said Alvotech has implemented “important enhancements across our quality system and the operations,” and that work to address findings is “well advanced.” He added the company “deliberately taken additional time to substantially de-risk future operational and regulatory disruption” and to ensure its resubmissions “fully address the Agency’s requirements.”
According to Wessman, the resubmission of Biologics License Applications for biosimilars to Simponi, SIMPONI ARIA, EYLEA, Prolia, and XGEVA is “now in the final stage of completion.” During Q&A, Chief Executive Officer Lisa Graver said the FDA is “on site” and that Alvotech expects the surveillance inspection to close out this week. Graver said the company is “on track” to resubmit the pending BLAs in the second quarter and that the “target is still and does remain the fourth quarter” for approvals.
Story Continues
Manufacturing changes pressured throughput; Fujifilm deal targets U.S. capacity
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Both Wessman and Graver said facility improvements have weighed on production. Wessman said the actions taken to address inspection findings “impacted manufacturing throughput,” contributing to a slowdown at points during 2025 and in the first quarter of 2026.
Graver said Alvotech is also exploring additional capacity “especially in the United States,” and highlighted a newly announced manufacturing agreement with Fujifilm Biotechnologies covering multiple products. She called the agreement “an important strategic step in further strengthening and diversifying our global manufacturing network, including expanded U.S.-based manufacturing capability.”
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Graver said the company is initiating technology transfer activities and expects to begin supplying products for the U.S. market “in the second half of 2027” as the transfer and qualification process progresses. In response to an analyst question about how much U.S. supply could come from Fujifilm, Graver said it is “too early to say,” while emphasizing that the Reykjavik site will “continue to be a predominant player across the markets.”
Commercial update: Humira and Stelara biosimilars; additional launches expanding
Graver said the company is seeing “solid underlying demand trends” and broader adoption of biosimilars. For AVT02, Alvotech’s biosimilar to Humira, she said available market data show it has become “the fastest-growing biosimilar to Humira in the United States” and has reached a 10% market share within the biosimilar segment.
During Q&A, Graver attributed the U.S. momentum in part to the “continued erosion of the Humira product” and an expanding biosimilar share of the market. She said Alvotech is seeing “an exit share of 60% of the market being biosimilar in the U.S. now,” and credited partner Teva’s commercial execution.
For AVT04, Alvotech’s biosimilar to Stelara, Graver said Teva continues to expand the product’s market in the U.S., while in Europe the product “continues to hold a leading share of the biosimilar segment in launched markets.” Addressing questions about Europe, she said the ustekinumab biosimilar market has shown “somewhat of a flattening in Q1,” but added she is not prepared to call that a full-year trend. She said biosimilar penetration is “about 56%” in Europe and noted continued growth in Germany.
Graver also said partners are progressing launches for Alvotech’s biosimilars to Simponi, Eylea, Prolia, and XGEVA, which received approvals in Europe, the U.K., and Japan late last year. She highlighted AVT05 (Simponi) as “the only biosimilar for the predominant presentation in the market,” and said the set of launches helps diversify the company’s commercial portfolio.
Pipeline milestones: Entyvio filings in Europe; high-dose Eylea program advances
On the pipeline, Graver said Alvotech submitted marketing authorization applications to the European Medicines Agency for AVT16 and AVT80, proposed biosimilars to Entyvio. She cited Entyvio sales in Europe “close to $2 billion and growing” and said the company believes it is positioned to be “within the first wave, if not the first biosimilar for this product.”
Graver also discussed AVT29, the company’s proposed biosimilar to high-dose Eylea. She said Alvotech is on track to submit an EMA application in 2026, and that the company has enrolled the first patients in a pivotal efficacy and safety study supporting a U.S. submission planned for 2028. Graver put the combined low-dose and high-dose Eylea market at approximately $8 billion, with $5 billion in the U.S. and $3 billion in Europe.
Financial results: Revenue down year over year; guidance maintained
Chief Financial Officer Linda Jónsdóttir said total revenue in the first quarter was $106 million, a 20% decline from the prior-year quarter. She attributed the impact to facility improvements and the associated slowdown, adding that the company expects Q4 2026 to be “the strongest quarter of the year.”
Jónsdóttir reported gross margin of 57% and said revenues were “equally split” between product and licensing revenue in the quarter. She said product margin was 11%, and noted that margins in the second half of 2025 and Q1 2026 were impacted by reduced manufacturing throughput. As manufacturing normalizes and volumes recover, she said the company expects to enter 2027 with a “stronger margin profile.”
Adjusted EBITDA was $24 million, representing a 23% margin, compared with $21 million and a 15% margin in Q1 2025. Jónsdóttir also said changes in regulatory guidance from the FDA and EMA, including circumstances where comparable clinical studies can be waived, have shifted emphasis toward analytical similarity. She said this allows certain development programs to meet capitalization criteria earlier under IAS 38, increasing the proportion of development costs capitalized beginning in 2026.
On revenue composition, Jónsdóttir said product revenue was $51 million, driven primarily by AVT02 (Humira) and AVT04 (Stelara), with incremental contributions from newly approved products AVT03 (Prolia/XGEVA), AVT05 (Simponi), and AVT06 (Eylea) as launches expanded across Europe, the U.K., and Japan. Licensing revenue was $55 million, which she described as “inherently lumpy” due to milestone timing. Graver added during Q&A that quarter-to-quarter variability in product revenue is largely due to “customer order pattern and invoicing,” not pricing.
Jónsdóttir said cash on hand at quarter-end was $64 million. Operating cash flow was negative $25 million, driven mostly by working capital, and the company paid net interest of $35 million in the quarter following a mid-2025 transition from PIK to cash interest. She reported CapEx of $7 million and “investment in accountables” of $39 million, and said management remains focused on achieving positive free cash flow in Q4 2026.
For the full year, Jónsdóttir reaffirmed revenue guidance of $650 million to $700 million and adjusted EBITDA guidance of $180 million to $220 million. She noted the low end of the revenue range does not include U.S. revenues from approvals and launches of AVT03, AVT05, or AVT06. Looking to 2027, she said Alvotech expects strong year-over-year growth supported by portfolio expansion, pipeline milestones, and improving manufacturing output after facility improvements.
About Alvotech (NASDAQ:ALVO)
Alvotech (NASDAQ:ALVO) is a global biopharmaceutical company specializing in the development, manufacturing and commercialization of biosimilar medicines. The company focuses on creating high‐quality, cost‐effective alternatives to established biologic therapies in areas such as immunology, oncology and other specialty care fields. By leveraging in‐house research and a vertically integrated manufacturing platform, Alvotech aims to bring approved biosimilars to market more rapidly and with greater cost efficiency than many traditional biosimilar developers.
Since its founding in 2013, Alvotech has built a diversified pipeline of monoclonal antibody biosimilars, targeting blockbuster reference products including adalimumab (originally branded Humira), bevacizumab (Avastin) and ustekinumab (Stelara).
The article "Alvotech Q1 Earnings Call Highlights" was originally published by MarketBeat.
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- Alvotech (ALVO) Reports Q1 Loss, Lags Revenue Estimates
May 7, 2026
Alvotech (ALVO) came out with a quarterly loss of $0.09 per share versus the Zacks Consensus Estimate of a loss of $0.07. This compares to earnings of $0.35 per share a year ago. These figures are adjusted for non-recurring items.
This quarterly report represents an earnings surprise of -28.57%. A quarter ago, it was expected that this company would post earnings of $0.13 per share when it actually produced a loss of $0.37, delivering a surprise of -384.62%.
Over the last four quarters, the company has surpassed consensus EPS estimates just once.
Alvotech, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $105.95 million for the quarter ended March 2026, missing the Zacks Consensus Estimate by 22.19%. This compares to year-ago revenues of $132.81 million. The company has topped consensus revenue estimates two times over the last four quarters.
The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call.
Alvotech shares have lost about 31.8% since the beginning of the year versus the S&P 500's gain of 6%.
What's Next for Alvotech?
While Alvotech has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock?
There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately.
Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions.
Ahead of this earnings release, the estimate revisions trend for Alvotech was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.
It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is -$0.01 on $174.48 million in revenues for the coming quarter and $0.01 on $673.86 million in revenues for the current fiscal year.
Story Continues
Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the bottom 40% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1.
One other stock from the same industry, Iovance Biotherapeutics (IOVA), is yet to report results for the quarter ended March 2026. The results are expected to be released on May 7.
This biotechnology company is expected to post quarterly loss of $0.19 per share in its upcoming report, which represents a year-over-year change of +47.2%. The consensus EPS estimate for the quarter has been revised 18.2% lower over the last 30 days to the current level.
Iovance Biotherapeutics' revenues are expected to be $77.11 million, up 56.3% from the year-ago quarter.
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Alvotech (ALVO) : Free Stock Analysis Report
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This article originally published on Zacks Investment Research (zacks.com).
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- Alvotech (ALVO) Reports Q1 Loss, Lags Revenue Estimates
May 6, 2026 · zacks.com
Alvotech (ALVO) came out with a quarterly loss of $0.09 per share versus the Zacks Consensus Estimate of a loss of $0.07. This compares to earnings of $0.35 per share a year ago.
- Alvotech Q1 2026 Financial Results
May 6, 2026
Alvotech
Alvotech (NASDAQ US: ALVO, ICELAND: ALVO, STOCKHOLM: ALVO SDB)
Financial Highlights
Asupplemental long‑form earnings release providing additional operational details and business update for Q1 2026 is available at: https://investors.alvotech.com/earnings-calendar under “Q1 2026 Earnings Call”. The supplemental document is provided solely for reference and is not part of this SEC Form 6‑K. The Form 6‑K should not be read together with, or construed as referring to, the supplemental long‑form release.
Q1 2026 Highlights
Total revenues1 were $105.9m compared to $132.8m in the same period last year Adjusted EBITDA1 was $24.4m with Gross Margin of 57%
Post-period end:
Submitted a Marketing Authorization Application to the European Medicines Agency for AVT16 and AVT80, proposed biosimilars to Entyvio® (vedolizumab)
Commenced a pivotal efficacy and safety study for AVT29 for Eylea HD® in support of a submission in the US in 2028 Entered into a strategic manufacturing agreement with FUJIFILM Biotechnologies, establishing a U.S.-based second source of commercial supply
Comments by Lisa Graver, CEO:
“During the quarter, we continued to execute across multiple strategic priorities, including progressing the FDA resubmission process, expanding our commercial portfolio, advancing high-value pipeline programmes, and further strengthening our manufacturing platform.
“In recent months, we have implemented several important improvements across our quality systems and operations. Importantly, we have deliberately taken additional time to substantially de-risk future operational and regulatory disruption and to ensure that when we resubmit to the FDA, we do so with a package that fully addresses the agency’s requirements and supports the long-term growth and value of the company.
“Both revenues and EBITDA were impacted in the quarter by a slowdown in production related to these facility improvements. We expect a recovery in product revenues as normal operations resume.
“Commercially, we continue to see strong underlying demand for biosimilars across our marketed portfolio, including continued momentum for our Humira biosimilar in the U.S. market.
“At the same time, we advanced several important pipeline programmes, including a marketing submission to the European Medicines Agency for our proposed biosimilar to Entyvio, and continued progress with our programme for high-dose Eylea, where the first patients have now been enrolled in a pivotal clinical study.
“In addition, we have today announced a strategic manufacturing agreement with FUJIFILM Biotechnologies covering multiple products in our portfolio. This is an important step to further strengthen and diversify our manufacturing network that supports the next phase of commercial launches.
Story Continues
“We remain highly focused on resubmitting our BLAs pending approval with the U.S. FDA in the second quarter. Actions taken since last year strengthen not only the packages for resubmission but also our operational platform more broadly, supporting future pipeline execution. With these improvements, we believe the company is well positioned for its next phase of growth.”
Outlook for 2026
Management anticipates total revenues to be in the range of $650-$700 million and adjusted EBITDA to be in the range of $180-220 million in 2026. The lower end of the revenue range assumes no revenues from new launches into the U.S. market in 2026.
Invitation to Q1 2026 management presentation:
Join us to listen to the live audio webcast at 8:00 AM EST (12:00 GMT, 13:00 CET) on Thursday, May 7, 2026.
The audio webcast will be accessible via the following link:
https://edge.media-server.com/mmc/p/ppckxq33
To participate via telephone in the Q&A session, please register using this link to obtain your PIN:
https://register-conf.media-server.com/register/BIdfe56c21c8d448efb09f3c30405bb00d
Presentation slides for the webcast and other materials are available under “Q1 2026 Earnings Call” at:https://investors.alvotech.com/earnings-calendar
For further information, please contact:
Media – alvotech.media@alvotech.com
Benedikt Stefansson
Sarah MacLeod
Investors -alvotech.ir@alvotech.com
Dr. Balaji V Prasad
Benedikt Stefansson
The information was submitted for publication through the agency of the contact persons.
Financial calendar:
Annual or interim results will be released on the dates specified below, after the close of U.S. markets. An earnings call is held on the following day, after release of the results. Please note that all dates are subject to change.
Quarter Date of release Date of earnings call Q2 2026 August 19, 2026 August 20, 2026 Q3 2026 November 11, 2026 November 12, 2026 Q4 2026 March 10, 2027 March 11, 2027
About Alvotech
Alvotech is a biotechnology company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high-quality, cost-effective products and services, enabled by a fully integrated approach and broad in-house capabilities. Five biosimilars are already approved and marketed in multiple global markets, including biosimilars to Humira® (adalimumab), Stelara® (ustekinumab), Simponi® (golimumab), Eylea® (aflibercept) and Prolia®/Xgeva® (denosumab). The current development pipeline includes nine disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. For more information, please visit https://www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release.
For more information, please visit our investor portal, and our website or follow us on social media on LinkedIn, Facebook, Instagram, and YouTube.
Forward Looking Statements
Certain statements in this communication may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements include, for example, Alvotech’s expectations regarding competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, regulatory submissions, review and interactions, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, market launches and financial projections. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Alvotech’s control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to factors set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that Alvotech may from time-to-time file or furnish with the SEC. There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Alvotech does not undertake any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication. Alvotech disclaims any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed.
Non IFRS Financial Measures
This Presentation may include projections of certain financial measures not presented in accordance with International Financial Reporting Standards (“IFRS”) including, but not limited to, Adjusted Revenues, EBITDA and certain ratios and other metrics derived therefrom. These non-IFRS financial measures are not measures of financial performance in accordance with IFRS and may exclude items that are significant in understanding and assessing the Company’s financial results. Therefore, these measures should not be considered in isolation or as an alternative to net income, cash flows from operations or other measures of profitability, liquidity or performance under IFRS. You should be aware that the Company’s presentation of these measures may not be comparable to similarly-titled measures used by other companies. The Company believes these non-IFRS measures of financial results provide useful information to management and investors regarding certain financial and business trends relating to the Company’s financial condition and results of operations. The Company believes that the use of these non-IFRS financial measures provide an additional tool for investors to use in evaluating ongoing operating results and trends and in comparing the Company’s financial measures with other similar companies, many of which present similar non-IFRS financial measures to investors. These non-IFRS financial measures are subject to inherent limitations as they reflect the exercise of judgments by management about which expense and income are excluded or included in determining these non-IFRS financial measures. Due to the high variability and difficulty in making accurate forecasts and projections of some of the information excluded from these projected measures, together with some of the excluded information not being ascertainable or accessible, the Company is unable to quantify certain amounts that would be required to be included in the most directly comparable IFRS financial measures without unreasonable effort. Consequently, no disclosure of estimated comparable IFRS measures is included and no reconciliation of the forward-looking non-IFRS financial measures is included. For the same reasons, the Company is unable to address the probable significance of the unavailable information, which could be material to future results.
1 Figures are adjusted to exclude items that are not indicative of our ongoing operating performance. See disclaimer on ‘Non IFRS Financial Measures’ at the end of this press release. As a foreign private issuer, Alvotech is not required to, and does not, prepare or file quarterly financial statements under IFRS or with the SEC. The financial information included in this Form 6-K reflects management’s current estimates and is presented for the purpose of providing an interim business update.
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