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01/10 16:34
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Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
The earnings call reveals strong financial performance with a 32% revenue increase and improved margins, alongside optimistic guidance and a raised revenue forecast. Product developments, particularly Joenja's expansion, are promising. While some uncertainties exist, such as RUCONEST's withdrawal impact, the overall sentiment remains positive due to the strong growth trajectory and strategic direction.
Total revenues $97.3 million in Q3 2025, up 30% year-over-year. Growth driven by strong performance of RUCONEST and Joenja.
Operating profit $15.8 million in Q3 2025, nearly 4x last year's result. Increase due to higher revenues, improved gross margin, and well-managed operating costs.
Operating cash flow $32 million in Q3 2025, restoring cash position to pre-Abliva acquisition levels. Driven by strong cash flow from operating activities.
RUCONEST revenue $82 million in Q3 2025, up 29% year-over-year. Growth fueled by new prescribers, patient enrollments, and vial volume increase.
Joenja revenue $15.1 million in Q3 2025, up 35% year-over-year. Growth driven by 25% increase in patients on treatment and success in identifying new APDS patients.
Gross profit $90.2 million in Q3 2025, up 33% year-over-year. Increase attributed to higher revenues and improved gross margin (93% vs. 91% in Q3 2024).
Cash and marketable securities $168.9 million at the end of Q3 2025, up from $130.8 million at the end of Q2 2025. Increase due to significant cash flow from operating activities.
Year-to-date total revenues $269.6 million for the first 9 months of 2025, up 32% year-over-year. Growth driven by strong performance of RUCONEST and Joenja.
Adjusted operating profit $29.7 million for the first 9 months of 2025, compared to a loss of $15.3 million in the same period of 2024. Improvement due to revenue growth and controlled operating expenses.
RUCONEST revenue growth: 29% year-on-year growth, driven by new prescribers and patient enrollments. It remains a cornerstone treatment for severe HAE patients.
Joenja revenue growth: 35% year-on-year growth, with a 25% increase in patients on treatment. Pediatric indication and geographic expansion are expected to drive further growth.
Geographic expansion: Joenja launched in the U.K., marking the start of focused geographic expansion plans.
Revenue growth: Total revenues grew by 30% in Q3 2025 compared to Q3 2024, driven by RUCONEST and Joenja.
Operating profit: Increased nearly 4x to $15.8 million compared to last year.
Cash flow: Operating cash flow reached $32 million, restoring cash position to pre-Abliva acquisition levels.
Cost optimization: Significant reduction in G&A headcount to optimize capital deployment.
Pipeline development: Advancing late-stage programs like KL1333 for primary mitochondrial disease, with potential $1 billion+ sales.
Regulatory progress: FDA granted priority review for Joenja's pediatric indication, with a PDUFA date of January 31, 2026.
Market potential: Research suggests APDS prevalence may be up to 100x higher than current estimates, opening larger market opportunities.
Market Competition: RUCONEST faces competition from a new oral on-demand therapy launched in July, which could impact its market share despite its unique value proposition.
Regulatory Risks: The approval of the pediatric indication for Joenja in the U.S. is pending with a PDUFA date of January 31, 2026. Delays or negative outcomes could impact growth projections.
Pipeline Uncertainty: The success of late-stage pipeline programs like KL1333 for primary mitochondrial disease is uncertain, with key data readouts not expected until late 2027.
Geographic Expansion Challenges: The launch of Joenja in the U.K. and other geographic expansions may face regulatory, market entry, and adoption hurdles.
Operational Costs: Despite strong revenue growth, operating expenses have increased, including $20.4 million in acquisition-related expenses and $7 million in restructuring costs, which could strain financials.
Economic Uncertainty: Broader economic conditions could impact patient access, pricing, and reimbursement for rare disease therapies.
Supply Chain Risks: The unique manufacturing process for RUCONEST could face disruptions, impacting its availability and revenue generation.
Revenue Guidance: Pharming has raised its full-year 2025 revenue guidance to $365 million to $375 million, up from the previous $335 million to $350 million, implying full-year revenue growth between 23% to 26%.
Joenja Pediatric Launch: The FDA has granted priority review for the pediatric indication of Joenja for patients aged 4 to 11, with an expected approval date of January 31, 2026. Preparations for the launch are on track, and 54 patients in this age group have already been identified, with one-third currently on therapy through an early access program.
Geographic Expansion: Joenja's launch in the U.K. is progressing well, marking the beginning of focused geographic expansion plans. Regulatory filings for Joenja are under review in Europe, Japan, and Canada, with approvals anticipated in 2026.
Pipeline Development: The pipeline includes KL1333 for primary mitochondrial disease, which is in a registrational study with a readout expected in late 2027. Additionally, two Phase II proof-of-concept studies for PIDs with immune dysregulation are on track for readouts in the second half of 2026.
Market Expansion for Joenja: Recent data suggests significantly higher APDS prevalence, potentially up to 100x higher than current estimates. Pharming is exploring this through predictive AI-driven models and global KOL advisory boards to identify patients who could benefit from targeted PI3K delta inhibition.
Financial Discipline: Pharming is optimizing G&A headcount to enhance financial discipline and ensure efficient capital allocation, aiming to maximize returns and support high-growth initiatives.
The selected topic was not discussed during the call.
The earnings call indicates significant challenges, particularly in Europe with EBITDA losses and high log costs. The Q&A highlights these issues, with management expecting improvements only by 2026. The company's financial health shows net debt and liquidity, but the uncertain path for Canfor Pulp and vague management responses on strategy further contribute to a negative outlook. While North American operations show some resilience, the overall sentiment leans negative due to European struggles and lack of clear strategic direction.
The earnings call reveals strong financial performance with a 32% revenue increase and improved margins, alongside optimistic guidance and a raised revenue forecast. Product developments, particularly Joenja's expansion, are promising. While some uncertainties exist, such as RUCONEST's withdrawal impact, the overall sentiment remains positive due to the strong growth trajectory and strategic direction.
The earnings call presents a largely positive outlook with strong revenue and profit growth, increased cash reserves, and raised revenue guidance. Despite some execution challenges in G&A expense reduction and potential bottlenecks in patient reclassification, the market strategy and financial health are solid. The Q&A section highlighted management's confidence in overcoming these challenges. The positive sentiment is reinforced by the company's strategic geographic expansion and robust product performance, notably RUCONEST and Joenja. These factors suggest a positive stock price movement in the short term.
The earnings report shows strong financial performance with a 42% revenue increase and improved gross margins. While there are risks related to regulatory issues and acquisition costs, the raised revenue guidance and ongoing growth in RUCONEST and Joenja are positive indicators. The reduction in G&A expenses suggests financial discipline. The Q&A reveals some uncertainties, but management's focus on growth and optimization is clear. Given these factors, the stock is likely to experience a positive movement in the short term.
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