Alvotech Reports Results for the First Quarter of 2025 and Provides Business Update

   -- Total Revenues in the first quarter of 2025 reached $132.8 million, 
      compared to $36.9 million in the same period last year, representing a 
      260% increase 
 
   -- Product Revenues in the first in the first quarter of 2025 reached $109.9 
      million, compared to $12.4 million in the same period last year, 
      representing a 786% increase 
 
   -- Adjusted EBITDA in the first quarter of 2025 was $20.5 million compared 
      to negative $38.4 million in 2023 
 
   -- Full year guidance increased to $600-$700 million in top line revenue and 
      $200-280 million adjusted EBITDA, following acquisition of proposed 
      biosimilar to Cimzia 
 
   -- Alvotech will conduct a business update conference call and live webcast 
      on Thursday May 8, 2025, at 8:00 am ET (12:00pm GMT). 

REYKJAVIK, Iceland, May 07, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO, or the "Company"), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today reported financial results for the first quarter of 2025 and provided a summary of recent pipeline and corporate highlights. Management will conduct a business update conference call and live webcast on March 8, 2025, at 8:00 am ET (12:00 pm GMT).

"Alvotech maintains its strong momentum, with positive cash flows from operating activities in the first quarter and healthy product margins, driven by new launches and increasing manufacturing efficiencies. In 2025 Alvotech expects to be free cash-flow positive, and I'm pleased to note that the business is self-funded going forward. Based on strong response to our acquisition of all rights to the proposed biosimilar to Cimzia and to the broadening of our development pipeline, we are increasing full year guidance, to $600-$700 million in top-line revenue and $200-$280 million in adjusted EBITDA," said Robert Wessman, Chairman and CEO of Alvotech. "Launching four new biosimilars remain key near-term priorities. With the acquisition of Xbrane's operations and expansion of our R&D activity into Sweden we continue building one of the most valuable pipelines in the industry and leveraging our investment in a unique vertically integrated platform for biosimilars development and manufacturing."

Business Highlights in Q1 2025

Alvotech and its U.S. commercial partner Teva Pharmaceutical announced the launch of SELARSDI$(TM)$ (ustekinumab-aekn) biosimilar to Stelara$(R)$, in the U.S. SELARSDI has been granted interchangeability to all presentations of the reference biologic Stelara(R), effective April 30, 2025. The partners also announced filing acceptance of U.S. Biologics License Applications (BLAs) for AVT05, a proposed biosimilar to Simponi(R) and Simponi Aria(R) (golimumab) and a BLA for AVT06, a proposed biosimilar to Eylea(R) (aflibercept). Alvotech is the first developer to file marketing applications for a proposed biosimilar to Simponi(R) or Simponi Aria(R) in major markets, including Europe, U.S., Canada and Japan.

Alvotech and Dr. Reddy's Laboratories announced the filing acceptance of a U.S. BLA for AVT03, a proposed biosimilar to Prolia and Xgeva (denosumab). Alvotech, Kashiv and Advanz announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) had accepted a marketing application for AVT23, a proposed biosimilar to Xolair(R) (omalizumab).

Alvotech acquired Xbrane's R&D operations in Sweden and all rights to a biosimilar candidate referencing Cimzia(R) (certolizumab pegol). Xbrane's shareholders have approved the acquisition, which is pending final approval from the relevant Swedish authorities.

Summary of the Financial Results for the first quarter of 2025

Cash position and sources of liquidity: As of March 31, 2025, the Company had cash and cash equivalents of $39.5 million. In addition, the Company had borrowings of $1,096.7 million, including $32.8 million of current portion of borrowings.

Product Revenue: Product revenue was $109.9 million for the three months ended March 31, 2025, compared to $12.4 million for the three months ended March 31, 2024. Revenue for the three months ended March 31, 2025, consisted of product revenue from sales of AVT02 in the U.S., Canada, and European countries, the sales of AVT04 in Canada, Japan, and European countries, and the launch of AVT04 in the U.S.

License and Other Revenue: License and other revenue was $22.9 million for the three months ended 31 March 2025, compared to $24.4 million for the three months ended 31 March 2024. The license and other revenue of $22.9 million was primarily attributable to the recognition of a $17.6 million relative to the product launch of AVT04 in the U.S., and $4.3 million relative to the achievement of a performance target of AVT04 in Europe.

Cost of product revenue: Cost of product revenue was $65.4 million for the three months ended March 31, 2025, compared to $20.0 million for the three months ended March 31, 2024. This is the result of sales in the period, including the launch of AVT02 in the U.S., the launch of AVT04 in the U.S., Canada, Japan and European countries, tempered by lower production-related charges and lower costs associated with FDA inspection readiness.

Research and development (R&D) expenses: R&D expenses were $38.2 million for the three months ended 31 March 2025, compared to $49.9 million for the year ended three months ended 31 March 2024. The decrease was primarily driven by a decrease of $0.8 million primarily related to programs which reached commercialization (i.e., AVT04), a decrease of $19.3 million related to programs for which the clinical phase is now substantially completed (i.e. AVT03, AVT05, and AVT06), and overall lower other R&D expenses of 2.8 million, partially offset by a $11.2 million increase in direct program expenses mainly due to AVT16 and AVT29 programs that are advancing through clinical phase.

General and administrative (G&A) expenses: G&A expenses were $18.6 million for the three months ended March 31, 2025, compared to $15.5 million for the three months ended March 31, 2024. The increase in G&A expenses was primarily attributable to an increase in legal fees, primarily in preparation for upcoming planned launches.

Operating profit / (loss): Operating profit was $10.6 million for the three months ended 31 March 2025, compared to ($48.4) million for the same period in the prior year. The increase of $59 million was primarily attributable to the sharp increase in product revenues driven by the expansion of our product commercialization.

Finance income: Finance income was $126.3 million for the three months ended March 31, 2025, compared to $0.8 million for the three months ended March 31, 2024. Finance income for the three months ended March 31, 2025 was primarily attributable to the change in fair value of the fair value of derivative liabilities, which was positively impacted by the decrease in the Company's share price during the period.

Finance costs: Finance costs were $35.5 million for the three months ended March 31, 2025, compared to $184.1 million for the three months ended March 31, 2024. Finance costs for three months ended March 31, 2025 primarily comprised of interest charges on outstanding debts of $1,096.7 million. Finance costs for the three months ended March 31, 2024, were primarily comprised of $140.9 million related to the fair value of derivative liabilities, which was negatively impacted by the increase in the Company's share price during the period, and $41.0 million of interest charges on outstanding debts of 978.1 million.

Income tax (expense) / benefit: Income tax benefit was $16.3 million for the three months ended March 31, 2025, compared to $6.4 million for the three months ended March 31, 2024. The change is driven by a $23.2 million increase in the U.S. dollar value of the Icelandic tax loss carry-forwards denominated in Icelandic krona that the Company expects to utilize against future taxable profits, due to the weakening of the U.S. dollar over the period. This increase is partly offset by a $13.9 million decrease in tax benefit corresponding to a decrease in operating losses reported for the three months ended 31 March 2025.

Profit / (loss) for the Period: Reported net profit was $109.7 million, or $0.39 per share and $0.35 per share on a basic and diluted basis, respectively, for the three months ended March 31, 2025, compared to a reported net loss of $218.7 million, or ($0.89) per share on a basic and diluted basis, for the same period in the prior year. As mentioned above, the net loss for the three months ended March 31, 2024, was heavily impacted by the fair value costs associated with our derivative liabilities.

Business Update Conference Call

Alvotech will conduct a business update conference call and live webcast on Thursday, May 8, at 8:00 am ET (12:00 noon GMT). Registration for the conference call and access to the live webcast is found on https://investors.alvotech.com/events/event-details/q1-2025-earnings, where you will also be able to find a replay of the webcast, following the call for 90 days.

About AVT02 (adalimumab)

AVT02 is a monoclonal antibody and has been approved as a biosimilar to Humira(R) (adalimumab) in over 50 countries globally, including the U.S., Europe, Canada, Australia, Egypt, Saudi Arabia and South Africa. It is currently marketed in the U.S. as SIMLANDI and under private label (adalimumab-ryvk), in Europe as HUKYNDRA, in Canada as SIMLANDI and in Australia as ADALACIP. Dossiers are also under review in multiple countries globally.

About AVT04 (ustekinumab)

AVT04 is a monoclonal antibody and a biosimilar to Stelara(R) (ustekinumab). AVT04 has been launched in Canada as JAMTEKI, in the EEA as UZPRUVO, in Japan as USTEKINUMAB BS $(F)$ and in the U.S. as SELARSDI (ustekinumab-aekn). Dossiers are also under review in multiple countries globally.

About AVT03

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