Alvotech (ALVO) Company Report

Shareholder rights firm Hagens Berman is scrutinizing Alvotech (NASDAQ: ALVO) over the propriety of its disclosures regarding its lead drug candidate AVT05 and manufacturing operations, following a dramatic revision to its full-year financial forecasts.
On November 2, 2025, Alvotech announced the FDA issued a Complete Response Letter (CRL) for its AVT05 Biologics License Application due to deficiencies identified at its Reykjavik manufacturing facility.
This led Alvotech to reduce its 2025 revenue guidance to $570-$600 million and adjusted EBITDA to $130-$150 million, representing approximately a 10% and 58% reduction from prior midpoints, respectively.
Following this news, Alvotech shares crashed about 33% on November 3, 2025.

2 days ago

Press Release

Alvotech Announces European Approval for AVT03 Biosimilar

ALVO

Product Launch

Alvotech (NASDAQ: ALVO) announced on November 25, 2025, that the European Commission (EC) has approved AVT03 as a biosimilar to Prolia® and Xgeva® (denosumab).
The European denosumab market, across all indications, is currently valued at approximately US$1.2 billion based on originator sales in the last 12 months including the second quarter of 2025.
AVT03 is approved in two presentations: as a biosimilar to Prolia® for the treatment of osteoporosis and bone loss, and as a biosimilar to Xgeva® for the prevention of skeletal related events in adults with advanced malignancies involving bone.
In Europe, AVT03 will be commercialized through partnerships with STADA and Dr. Reddy's, with each partner holding semi-exclusive rights in the EEA, Switzerland, and the UK.

Nov 24, 2025, 10:30 AM

Press Release

Alvotech and Advanz Pharma Receive EEA Marketing Approval for Gobivaz® Biosimilar

ALVO

Product Launch

New Projects/Investments

Alvotech and Advanz Pharma announced that the European Commission (EC) has granted marketing authorizations in the European Economic Area (EEA) for Gobivaz®, Alvotech's biosimilar to Simponi® (golimumab).
Gobivaz® is the first biosimilar to Simponi® (golimumab) to gain approval in the European market.
The approvals cover Gobivaz® 50 mg/0.5 mL and 100mg/mL in both pre-filled syringe and autoinjector formats, for the treatment of various immune-mediated diseases in adults and children.
This marks the second biosimilar to receive approval through the partnership between Alvotech and Advanz Pharma.

Nov 20, 2025, 12:45 PM

6-K

Alvotech Updates 2025 Financial Guidance and Provides Regulatory and Pipeline Updates

ALVO

Guidance Update

Product Launch

Revenue Acceleration/Inflection

Alvotech revised its 2025 guidance to $600 million in revenue and $130-$150 million in EBITDA, down from an earlier midpoint of $650 million revenue and $250 million EBITDA, attributing the change to a temporary production slowdown following FDA observations. The company achieved EBITDA positive status last year.
The company currently markets biosimilar Humira (Simlandi), launched in 2024 and now the second largest biosimilar in the U.S. by market share, and biosimilar Stelara, launched around Q2 2025. Alvotech received a Complete Response Letter (CRL) for its biosimilar Symphony Biologics License Application (BLA) due to facility observations, but is confident in resolving these and aims to be the first to market in the U.S. with biosimilar Symphony next year.
Alvotech has a robust pipeline with upcoming launches including Eylea (approved in Japan, U.K., Europe) and Symphony (expected in Europe this quarter and U.S. next year), and views the abolition of Phase 3 clinical trials for biosimilars as an advantage to expand its development programs from 4-5 to 5-6 programs annually.

Nov 18, 2025, 3:30 PM

Transcript

Alvotech Updates on Financial Guidance, Regulatory Status, and Product Pipeline

ALVO

Guidance Update

Product Launch

Alvotech revised its financial guidance for this year, expecting $600 million in revenue and $130 million-$150 million in EBITDA, a reduction from earlier projections due to a temporary production slowdown caused by facility remediation processes. The company became EBITDA positive last year.
The company received a Complete Response Letter (CRL) from the FDA for its biosimilar Symphony BLA, citing pending facility observations rather than deficiencies in the application itself. Alvotech has implemented a 180-step remediation process (95% complete) and remains confident in its goal to be first to market in the U.S. next year for Symphony, while its facility continues to supply Humira and Stelara.
Alvotech currently markets biosimilar Humira (Simlandi), launched in 2024 and now the second largest biosimilar in the U.S. by market share, and biosimilar Stelara, introduced in Q2 this year. The company is expanding its portfolio, transitioning from two to six products with upcoming launches of Prolex, Jiva, Symphony, and Eylea.

Nov 18, 2025, 3:30 PM

Transcript

Alvotech Revises 2025 Guidance and Details Product Pipeline Progress

ALVO

Guidance Update

Product Launch

New Projects/Investments

Alvotech revised its 2025 guidance to an EBITDA of $130-$150 million on a revenue base of approximately $600 million, down from an earlier midpoint guidance of $250 million EBITDA on $650 million revenue, primarily due to a temporary production slowdown for facility remediation.
The company reported becoming EBITDA positive last year (2024) and has achieved over 125% CAGR in revenues over the last four years, growing from $40 million in FY21 to an expected $600 million this year (2025).
Alvotech currently markets biosimilar Humira (Simlandi), launched in 2024 and now the second largest biosimilar in the U.S. by market share, and biosimilar Stelara, introduced in Q2 2025.
Despite receiving a Complete Response Letter (CRL) for its biosimilar Symphony BLA due to facility observations, Alvotech is confident in resolving the issues and aims to be the first to market with biosimilar Symphony in the U.S. next year (2026). The facility remains approved and continues manufacturing existing products.
The company is transitioning from a two-product to a six-product company with upcoming launches of Prolex, Jiva, Symphony, and Eylea, and maintains a comprehensive pipeline of 30+ programs.

Nov 18, 2025, 3:30 PM

Transcript

Alvotech Reports Q3 2025 Results and Revised Full-Year Outlook

ALVO

Earnings

Guidance Update

Product Launch

Alvotech reported total revenues of $420 million for the first nine months of 2025, marking a 24% increase from the same period last year, driven by an 85% increase in product and service revenue to $237 million.
For the first nine months of 2025, the company achieved a net profit of $136.5 million (or $0.47 per share), a significant turnaround from a net loss in the prior-year period, while Adjusted EBITDA decreased by 21% to $68 million.
The full-year 2025 outlook for total revenues has been revised to $570 million - $600 million, and for Adjusted EBITDA to $130 million - $150 million.
During Q3 2025, Alvotech received marketing approvals for three new biosimilars in Japan and obtained recommendations for approval or marketing authorizations in Europe.

Nov 17, 2025, 12:04 PM

6-K

Alvotech Faces Investor Scrutiny Following Revised 2025 Financial Guidance and FDA CRL

ALVO

Guidance Update

Legal Proceedings

Profit Warning

Shareholder rights firm Hagens Berman is investigating Alvotech (ALVO) regarding the propriety of its disclosures concerning its lead drug candidate, AVT05, and manufacturing operations, following a dramatic revision to the company's full-year financial forecasts for 2025.
On November 2, 2025, Alvotech announced that the FDA issued a Complete Response Letter (CRL) for its Biologics License Application (BLA) for AVT05, citing deficiencies identified during a pre-license inspection of its Reykjavik manufacturing facility.
As a result, Alvotech reduced its 2025 revenue guidance from an initial range of $600-$700 million to $570-$600 million, and its adjusted EBITDA guidance from $200-$280 million to $130-$150 million.
This revision represents approximately a 10% reduction in the revenue forecast midpoint and a 58% reduction in the adjusted EBITDA forecast midpoint, causing Alvotech shares to crash about 33% on November 3, 2025.

Nov 13, 2025, 2:06 PM

Press Release

Alvotech Reports Q3 2025 Results and Revises Full-Year Guidance

ALVO

Earnings

Guidance Update

Product Launch

Alvotech reported $420 million in total revenues for the first nine months of 2025, marking 24% year-on-year growth, with an adjusted EBITDA of $68 million. For Q3 2025, adjusted EBITDA was $14 million on $81 million in licensing revenues.
The company revised its full-year 2025 revenue guidance to $570 million-$600 million and adjusted EBITDA to $130 million-$150 million. This revision follows a Complete Response Letter (CRL) from the FDA for its proposed biosimilar to Simponi, citing unresolved issues from a facility inspection.
Despite the CRL, the Reykjavik manufacturing facility remains FDA-approved for current marketed products, and approval for the Simponi biosimilar BLA is anticipated as early as the first half of 2026.
Alvotech is proceeding with the launch of three biosimilars (AVT06, AVT05, AVT03) in Europe this quarter, having secured approvals in various markets for these products.

Nov 13, 2025, 1:00 PM

Transcript

Alvotech Reports Q3 2025 Results, Updates Guidance Following FDA CRL

ALVO

Guidance Update

Product Launch

Management Change

Alvotech received a Complete Response Letter (CRL) from the FDA for its proposed biosimilar to Simponi, citing unresolved issues identified during an inspection of its Reykjavik facility in July 2025.
The company has revised its full-year 2025 outlook, now projecting revenues between $570 million and $600 million and adjusted EBITDA between $130 million and $150 million.
Approval for the Simponi biosimilar in the U.S. is now anticipated as early as the first half of 2026.
Alvotech is preparing for European launches of its biosimilars to Eylea (AVT06), Simponi (AVT05), and Prolia/Xgeva (AVT03) in the fourth quarter of 2025.
Joseph McClellan has been appointed Chief Operating Officer, taking responsibility for technical operations, R&D, supply chain, and project management, to strengthen leadership at the Reykjavik facility.

Nov 13, 2025, 1:00 PM

Transcript

Earnings Transcripts

Quarterly earnings call transcripts for Alvotech.

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