uniQure N.V. reported a net loss of $239.6 million for the fiscal year ending December 31, 2024, a decrease from the $308.5 million loss recorded in 2023. The company generated total revenues of $27.1 million, up from $15.8 million in the previous year, primarily driven by increased license and collaboration revenues related to its gene therapy product HEMGENIX®. The rise in revenues reflects a significant increase in collaboration activities, particularly with CSL Behring, which contributed $10.9 million in collaboration revenue, compared to $2.3 million in 2023. Despite the revenue growth, the company continues to face substantial operating expenses, totaling $214.8 million, which included $143.8 million in research and development costs.
The company underwent significant organizational changes in 2024, including a restructuring that resulted in a 65% reduction of its workforce, eliminating approximately 300 positions. This move was part of a broader strategy to conserve capital and streamline operations following the sale of its Lexington manufacturing facility to Genezen Holdings. The Lexington Transaction, completed in July 2024, included a commercial supply agreement for HEMGENIX® and is expected to reduce operating costs. However, the company recorded a $1.2 million gain from this divestment, while also incurring $5.2 million in severance costs related to the workforce reduction.
uniQure's clinical pipeline remains a focal point, with ongoing trials for its lead product candidate, AMT-130, aimed at treating Huntington's disease. The FDA granted AMT-130 Regenerative Medicine Advanced Therapy (RMAT) designation in June 2024, and the company has reached an agreement with the FDA on key elements of an accelerated approval pathway. Interim data from clinical trials indicated a statistically significant slowing of disease progression in patients treated with AMT-130. Additionally, the company has initiated clinical trials for other candidates, including AMT-260 for refractory mesial temporal lobe epilepsy, AMT-162 for SOD1-ALS, and AMT-191 for Fabry disease.
Looking ahead, uniQure anticipates that its existing cash and cash equivalents, totaling $367.5 million as of December 31, 2024, will be sufficient to fund operations through the second half of 2027. The company plans to continue advancing its clinical programs and is preparing for the potential commercialization of AMT-130. However, it acknowledges the need for additional funding to support the development of its product candidates and to navigate the complexities of regulatory approvals and market acceptance. The company’s future success will depend on its ability to effectively manage its resources, maintain regulatory compliance, and achieve favorable outcomes in its clinical trials.
About uniQure N.V.
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