Pharming Group, led by CEO Sijmen de Vries, reported robust third-quarter results during an earnings call, with positive cash flows from RUCONEST exceeding $200 million in annual sales. The company also noted a successful launch and ongoing growth of Joenja, contributing $10.3 million in revenues year-to-date. Pharming Group is in active dialogue with the FDA for a second indication for leniolisib and is exploring new in-licensing opportunities or acquisitions in the rare disease space.
Key takeaways from the call include:
- Positive cash flows from RUCONEST, contributing over $200 million in annual sales.
- Successful launch and growth of Joenja, generating $10.3 million in revenues year-to-date.
- Active dialogue with the FDA for a second indication for leniolisib.
- Exploration of new in-licensing opportunities or acquisitions in the rare disease space.
- Increased revenues, gross profit, and operating costs reported for Q3, with a net profit and an increase in cash and cash equivalents.
The company discussed the beneficial impact of leniolisib in treating patients with APDS (Activated PI3K Delta Syndrome), with patients experiencing a reduction in infection rates and improved immune cell function. Regulatory progress updates indicate submissions to the European Medicines Agency, with an expected opinion in the current quarter. Pharming Group plans to file for approval in the UK, Japan, Australia, Canada, and Israel.
In terms of future plans, the company expects single-digit growth in RUCONEST revenues and intends to continue investing in Joenja's launch and development. They also plan to develop leniolisib in additional indications and explore investment opportunities in rare diseases. Despite disruptive changes in the HAE market, the company maintains that there is still a need for RUCONEST.
Stephen Toor, a representative from Pharming Group, discussed the continued need for their IV C1 esterase inhibitor therapy, RUCONEST, despite disruptions caused by the pandemic. The company is planning to launch Joenja in various markets, starting with Germany and then targeting other major markets in Europe, Australia, and Canada between 2024 and 2025.
The company also highlighted their patient assistance program, providing free supply of RUCONEST to patients in need, and working with patients and physicians to find suitable insurance plans for ongoing paid therapy. An update was provided on a pediatric study for Joenja, revealing that enrollment is almost complete, with data release and regulatory work to be determined once the study is fully enrolled.
The next update is expected during the full year results call in March of next year.
InvestingPro Insights
Drawing from real-time data from InvestingPro, Pharming Group has an adjusted market cap of $7300M and a PEG ratio of 0.21 as of Q3 2023. The company also displayed a significant gross profit margin of 88.86% and a quarterly revenue growth of 22.98% in Q3 2023.
In light of the InvestingPro Tips, the company's revenue growth has been accelerating, and it has impressive gross profit margins. However, it's essential to note that the company's net income is expected to drop this year, and it has not been profitable over the last twelve months.
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