Alvotech (ALVO), a biosimilar medicine developer, reported fourth-quarter and full-year 2025 results that reflected revenue growth. In addition, the firm reaffirmed its 2026 outlook.
Following the news, ALVO is up 2.11% in the pre-market.
For the fourth quarter, Adjusted EBITDA increased 218.8% to $69 million from $21.7 million in the prior year.
Total revenue increased to $173.2 million, up 12.9% from $153.4 million in the year ago.
For the full year 2025, the firm swung to a profit of $27.92 million from a loss of $231.86 million in the prior year.
Total comprehensive profit of $31.49 million was reported for 2025 compared to a comprehensive loss of $232.55 million in the year-ago period.
On a per-share basis, the firm reported basic earnings of $0.10, compared with loss of $0.87 in the prior year.
Adjusted EBITDA jumped 26.6% to $137.1 million from $108.3 million in the prior year.
The full-year 2025 revenue is up 20.6% to $593.2 million from $492 in the last year.
The firm reported a cash balance of $172.4 million as of December 31, 2025.
Looking ahead to 2026, management reaffirmed its revenue guidance of $650 to $700 million, reflecting double-digit sales growth.
Adjusted EBITDA is expected to increase to $180-$220 million, supported by commercialised products and the launch of newly approved products in Europe, the UK and Japan.
Alvotech anticipates receiving U.S. approval by late 2026 for four Biologics License Applications from the U.S. Food and Drug Administration, with minimal impact on the topline.
The two FDA-approved biosimilars of Alvotech in the US include AVTO2, or high-concentration, low-volume Adalimumab and AVTO4 or Ustekinumab, under the immunology therapeutic area.
Regarding the regulatory observations made by the FDA at its Reykjavik manufacturing facility and the affected applications, Róbert Wessman noted: "Based on the progress made so far, we expect to resubmit the affected applications to the FDA during the second quarter of 2026."
ALVO has traded between $3.45 and $11.85 in the last year. The stock closed Wednesday's trade at $3.80, down 0.52%.
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