Pharming Group: Revenue Up 27%, 1,800 Patients Could Change Everything
Pharming Group reports strong 2025 results with a 27% increase in revenue and a shift to operational profitability, marking a strategic turning point for the biopharmaceutical group. However, the company faces a significant challenge: identifying up to 1,800 patients with uncertain genetic variants that could transform the potential market for its flagship treatment, Joenja.
Financial Performance and Regulatory Milestones
Pharming's total revenues reached USD 376.1 million in 2025, up 27% from USD 297.2 million in 2024. RUCONEST®, the group's first commercialized treatment, generated USD 317.9 million, a growth of 26%. Joenja®, its second commercialized product for treating a rare immune pathology (APDS), recorded USD 58.2 million in revenue, up 29%. This momentum allowed Pharming to achieve an operating profit of USD 25.8 million, compared to a loss of USD 8.6 million in 2024. Operational cash flow was USD 54.7 million, reflecting a substantial improvement in cash generation. However, these performances are contingent on pending regulatory approvals: Joenja® awaits an FDA decision in March 2026 regarding its pediatric expansion, while European approval is expected in the first half of 2026.
Clinical Challenges and Market Opportunities
Behind the growth figures lies a major clinical question that could redefine the commercial opportunity for Joenja®. The group has identified 998 patients diagnosed with APDS globally as of December 31, 2025, including 274 in the United States. But the real challenge lies elsewhere: a study published in June 2025 at Columbia University has opened the possibility of reclassifying significant uncertainty variants (VUS) in the genes involved in APDS. This reclassification could diagnose up to 1,800 additional American patients currently carrying these indeterminate variants. The group announced that additional data would be needed, temporarily blocking this advancement. Although only 120 patients are currently under paid treatment in the United States (+25% in one year), resolving the genetic puzzle could multiply this number, transforming Joenja® from a niche product into a substantial market treatment.
Moderate Growth Expectations and Critical Milestones for 2026
Pharming anticipates moderate growth for 2026, with total revenues expected between USD 405 and 425 million, representing an increase of 8% to 13%. This guidance reflects a cautious approach, as the group prefers to let regulatory catalysts materialize. Several critical milestones are anticipated: Joenja received a Complete Response Letter from the FDA on January 30, 2026, regarding its pediatric extension, and a meeting with the agency is expected in March to define the conditions for a new submission. Canadian approval is expected mid-year, and notably, an opinion from the European regulator is expected in the first half of 2026. Clinically, results from two Phase II trials evaluating leniolisib for other primary immunodeficiencies are expected in the second half of 2026, with a market potential 'substantially larger' than APDS. Finally, the FALCON trial of napazimone, acquired through the purchase of Abliva for USD 68 million, is expected to complete recruitment in 2026, with data by the end of 2027. These multiple catalysts position Pharming to accelerate its growth, but success will heavily depend on the group's ability to transform these scientific and regulatory opportunities into concrete commercial expansion.
