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Alvotech (ALVO)

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Recent press releases and 8-K filings for ALVO.

Alvotech announces European launch of first-in-market biosimilar to Simponi® (golimumab)
ALVO
Product Launch
New Projects/Investments
  • Alvotech announced the European launch of Gobivaz® (golimumab), its biosimilar to Simponi® (golimumab), on December 22, 2025.
  • Gobivaz is the first marketed biosimilar to Simponi worldwide.
  • The biosimilar is being commercialized exclusively in Europe by Alvotech’s partner, Advanz Pharma, and its introduction in the United Kingdom is supported by an NHS England tender award.
19 hours ago
Alvotech Announces European Launch of First-in-Market Simponi Biosimilar
ALVO
Product Launch
  • Alvotech (ALVO) has announced the European launch of Gobivaz® (golimumab), its biosimilar to Simponi® (golimumab), making it the first marketed biosimilar to Simponi worldwide.
  • The product is being commercialized exclusively in Europe by Alvotech’s partner, Advanz Pharma Holdco Limited.
  • The introduction of Gobivaz in the United Kingdom is supported by a National Health Service (NHS) England tender award, which provides a defined framework for its adoption within NHS services.
2 days ago
Alvotech and Teva Secure U.S. Settlement Date for AVT06 Biosimilar
ALVO
Product Launch
Legal Proceedings
New Projects/Investments
  • Alvotech and Teva Pharmaceuticals have secured a settlement and license agreement with Regeneron Pharmaceuticals Inc. for the U.S. launch of AVT06, a proposed biosimilar to Eylea® (aflibercept).
  • The agreement establishes a U.S. license entry date for AVT06 in the fourth quarter of 2026, with potential for an earlier launch under certain circumstances, pending FDA approval.
  • AVT06 has already received marketing approvals in the United Kingdom, Japan, and the European Economic Area.
5 days ago
Alvotech and Teva Secure U.S. Settlement Date for Eylea Biosimilar
ALVO
Product Launch
Legal Proceedings
New Projects/Investments
  • Alvotech and Teva Pharmaceuticals have reached a settlement and license agreement with Regeneron Pharmaceuticals Inc. for AVT06, a proposed biosimilar to Eylea® (aflibercept) in the United States.
  • The agreement grants a U.S. license entry date for AVT06 in the fourth quarter of 2026, with potential for an earlier launch under certain circumstances.
  • AVT06 has already received marketing approvals in the United Kingdom, Japan, and the European Economic Area.
  • In January 2024, Alvotech announced positive top-line results from a confirmatory clinical study, demonstrating high similarity between AVT06 and Eylea®.
5 days ago
Alvotech Faces Investor Scrutiny and Revises 2025 Financial Guidance Following FDA CRL
ALVO
Legal Proceedings
Guidance Update
Demand Weakening
  • Shareholder rights firm Hagens Berman is investigating Icelandic biopharmaceutical company Alvotech (ALVO) regarding its disclosures about its lead drug candidate AVT05 and manufacturing operations.
  • The scrutiny follows an FDA Complete Response Letter (CRL) issued on November 2, 2025, which identified deficiencies at Alvotech's Reykjavik manufacturing facility that must be resolved before the Biologics License Application (BLA) for AVT05 can be approved.
  • Consequently, Alvotech significantly reduced its full-year 2025 financial forecasts, revising revenue guidance to $570-$600 million and adjusted EBITDA to $130-$150 million. This represents a 10% reduction from the prior revenue midpoint and a 58% reduction from the prior adjusted EBITDA midpoint.
  • The news caused Alvotech shares to crash approximately 33% on November 3, 2025, resulting in a loss of hundreds of millions of dollars in market value.
7 days ago
Alvotech Successfully Places Convertible Bonds and Updates Financial Guidance
ALVO
Debt Issuance
Guidance Update
New Projects/Investments
  • Alvotech successfully placed USD 108 million senior unsecured convertible bonds due 2030 in a significantly oversubscribed offering, with settlement expected on December 22, 2025.
  • The bonds carry a coupon of 6.875%, payable semi-annually, and have an initial conversion price of USD 5.9224 per share.
  • The net proceeds from the offering will be used to continue investment in Alvotech's R&D pipeline, which is expected to be around USD 250 million in 2026, and to scale production capacity to support 4 new global product launches through 2026.
  • The company reaffirmed its full-year 2025 outlook, anticipating total revenues in the range of $570 to $600 million and adjusted EBITDA between $130 and $150 million.
  • For 2026, Alvotech anticipates total revenues in the range of $650-$700 million and expects adjusted EBITDA to increase to $180-$220 million.
7 days ago
Alvotech Successfully Places USD 108 Million Convertible Bonds
ALVO
Debt Issuance
New Projects/Investments
Convertible Preferred Issuance
  • Alvotech successfully placed USD 108 million senior unsecured convertible bonds due 2030 in a significantly oversubscribed offering.
  • The net proceeds will be used to continue investment in R&D, with an expected investment of approximately USD 250 million in 2026, scale production capacity, and support 4 new global product launches through 2026.
  • The convertible bonds carry a coupon of 6.875% and have an initial conversion price of USD 5.9224 per share, representing a 25% premium over the share price of USD 4.7379 used in the Concurrent Delta Placement.
  • Alvotech has entered into a lock-up undertaking not to issue new shares for three months and equity-linked securities for twelve months following the settlement of the Convertible Bonds on December 22, 2025.
7 days ago
Alvotech Reconfirms 2025 Guidance, Provides 2026 Outlook, and Addresses Regulatory Matters
ALVO
Guidance Update
Product Launch
New Projects/Investments
  • Alvotech reconfirmed its 2025 guidance for top line revenue of $570 million-$600 million and EBITDA of $130 million-$150 million, and issued 2026 guidance anticipating revenues of $650 million-$700 million and Adjusted EBITDA of $180 million-$220 million.
  • The company received Complete Response Letters (CRLs) from the FDA for three of its four BLAs submitted in Q4 2024, with another anticipated, citing issues related to manufacturing processes and quality control, which the company is addressing.
  • Alvotech anticipates becoming cash flow positive in Q4 2026 and plans to invest approximately $250 million in R&D during 2026 to advance its pipeline of over 30 molecules.
  • On-market biosimilars, including those for Humira and Stelara, are demonstrating strong momentum, with the Humira biosimilar holding the second largest market share in the U.S..
  • Recent approvals and launches in Europe, the U.K., and Japan for biosimilars to Simponi, Eylea, and Prolia/Xgeva are contributing to revenue diversification.
Dec 16, 2025, 5:00 PM
Alvotech Provides Investor Update on Financial Guidance and Regulatory Status
ALVO
Guidance Update
Product Launch
New Projects/Investments
  • Alvotech reconfirmed its 2025 revenue guidance of $570 million to $600 million and adjusted EBITDA guidance of $130 million to $150 million. For 2026, the company anticipates revenues in the range of $650 million to $700 million and adjusted EBITDA of $180 million to $220 million.
  • The company received Complete Response Letters (CRLs) from the FDA for three of its four BLAs submitted in Q4 2024, specifically for biosimilars to Simponi, Simponi Aria, and Eylea, and anticipates a CRL for ABT03 (Prolia and Xgeva). Management is confident in resolving these issues, having implemented close to 200 CAPAs.
  • Alvotech's biosimilar to Humira (ABT02) holds the second-largest market share among Humira biosimilars in the U.S. and a top position in several European markets. The company is also launching three products (biosimilars to Simponi, Eylea, and Prolia/Xgeva) in the U.K., Japan, and the European Economic Area, targeting an approximate $3 billion ex-U.S. market.
  • Alvotech plans to invest around $250 million in R&D for 2026 and expects to be cash flow positive in Q4 2026, with new funding supporting this goal.
Dec 16, 2025, 5:00 PM
Alvotech Reconfirms 2025 Guidance and Issues 2026 Outlook Amidst FDA Review
ALVO
Guidance Update
Product Launch
New Projects/Investments
  • Alvotech reconfirmed its 2025 guidance, projecting revenues between $570 million and $600 million and EBITDA between $130 million and $150 million, reflecting a 19% increase in revenues and a 30% improvement in EBITDA year-on-year.
  • For 2026, the company introduced new guidance, forecasting revenues of $650 million to $700 million and Adjusted EBITDA of $180 million to $220 million.
  • The company received Complete Response Letters (CRLs) from the FDA for three of its four BLAs submitted in Q4 2024, related to biosimilars for Simponi, Simponi Aria, and Eylea, and anticipates a CRL for ABT03. These issues, concerning manufacturing processes and quality control, are being addressed, and the company remains confident in its existing US market products.
  • Alvotech plans a significant R&D investment of approximately $250 million in 2026 and anticipates achieving cash flow positivity in Q4 2026.
Dec 16, 2025, 5:00 PM
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