• Full-Year Revenue: Increased by 21% to $297 million.
• RUCONEST Revenue: Grew 11% to $252 million.
• Joenja Revenue: Increased by 147% to $45 million.
• Q4 Revenue Growth: 14% increase compared to Q4 2023.
• Gross Profit Growth: Increased by 9% despite a one-off inventory impairment.
• Operating Profit: Increased by $5.6 million, marking the second consecutive quarter of operating profit.
• Net Profit: Transitioned from a loss in Q4 2023 to a net profit in Q4 2024.
• Operating Cash Flow: Positive for the second consecutive quarter.
• 2025 Revenue Guidance: Expected between $315 million and $335 million, indicating a growth rate of 6% to 13%.
• Operating Expenses: Expected to remain flat in 2025, excluding Abliva-related costs.
• Abliva Acquisition Cost: $66.1 million, funded with available cash.

• Warning! GuruFocus has detected 3 Warning Signs with PHGUF.

Release Date: March 13, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Pharming Group (PHGUF) reported a 21% increase in full-year 2024 revenues, reaching $297 million, surpassing their guidance range.
• RUCONEST sales grew by 11% to $252 million, driven by a 24% increase in new patient enrollments and an 11% expansion of the prescriber base.
• Joenja revenue increased by 147% to $45 million, with significant growth expected from new patient enrollments and geographic expansion.
• The acquisition of Abliva is seen as a strategic move to enhance Pharming's pipeline, particularly in the area of primary mitochondrial diseases.
• Pharming Group (PHGUF) maintained positive operating cash flow and operating profits for the last two quarters of 2024, indicating strong financial health.

Negative Points

• Gross profit growth was lower than revenue growth due to a one-off inventory impairment related to RUCONEST production issues.
• Operating expenses increased by 10% due to investments in Joenja, which may impact profitability if not managed carefully.
• The company faces potential challenges from new competition in the HAE market, which could impact RUCONEST's market share.
• There are concerns about potential US tariffs affecting drug pricing and supply chain, which could impact Pharming's operations.
• The integration of Abliva and associated costs, estimated at $30 million for 2025, could strain resources if not managed effectively.

Q & A Highlights

Q: Could you elaborate on the target population for KL133 in primary mitochondrial disease and the potential treatment eligibility? A: Anurag Relan, Chief Medical Officer, explained that the target population for KL133 includes patients with mitochondrial DNA mutations, which represent 80% of all primary mitochondrial diseases (PMDs). The estimated addressable population is about 30,000 patients in the US and large European markets.

Q: Regarding the 188 patients on the expanded access program, are any of them on paid therapy, and can you provide a breakdown of their locations? A: Stephen Toor, Chief Commercial Officer, stated that these patients are in multiple countries, including key markets. They are primarily in early access programs, compassionate use, and clinical trials, with some on paid therapy through name patient programs. Specific numbers or revenue details are not publicly disclosed.

Q: Can you clarify the anticipated additional OpEx from the Abliva acquisition and any potential exposure to US tariffs? A: Fabrice Chouraqui, CEO, mentioned that the $30 million OpEx for Abliva in 2025 includes $17 million for R&D and the rest for non-recurring transaction and integration costs. Regarding US tariffs, the company is monitoring the situation and exploring supply chain adaptations to minimize potential impacts.

Q: What is the outlook for RUCONEST in 2025, considering new competition, and were there any stocking effects in Q4? A: Fabrice Chouraqui, CEO, confirmed that Q4 results were driven by strong demand, not stocking effects. RUCONEST's unique profile and strong patient experience position it well to remain a treatment of choice for HAE attacks despite new oral entrants. Market research supports this confidence.

Q: What are the expectations for the CVID trials, and will a Phase 3 study be necessary? A: Anurag Relan, Chief Medical Officer, indicated that a Phase 3 study is anticipated for CVID, similar to the approach with APDS. The Phase 2 program will provide more details on the development path and potential regulatory requirements.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.