Pharming Group Q1 2024 Financial Results and Business Update

Pharming Group N.V. released its unaudited financial results for the first quarter ending March 31, 2024. The company reported significant growth in revenues, primarily driven by the U.S. commercial launch of Joenja® and the continued robust performance of RUCONEST®.

For the first quarter of 2024, Pharming’s total revenue increased by 31% to $55.6 million, compared to $42.5 million in the same period in 2023. This surge was led by the revenues from RUCONEST®, which grew by 8% to $46.0 million, and the initial revenue introduction of Joenja® (leniolisib), which brought in $9.6 million, signifying a 21% increase compared to the fourth quarter of 2023. This growth keeps the company on track to meet its annual revenue guidance range of $280 million to $295 million, reflecting a growth rate of 14-20%.

Pharming’s CEO, Sijmen de Vries, highlighted the strong first-quarter performance and noted that the company is making considerable progress in expanding the market for Joenja® both within the U.S. and in other global markets. As of March 31, 2024, 83 patients in the U.S. are on Joenja® paid therapy, with additional patients enrolled and pending. Outside the U.S., 138 patients are on leniolisib therapy through access programs or clinical trials, reflecting the growing demand for Joenja® globally.

Efforts to identify additional Activated Phosphoinositide 3-Kinase Delta Syndrome (APDS) patients are ongoing, with a focus on genetic and family testing, and resolving Variants of Uncertain Significance (VUS). These efforts have led to the increase in the number of identified APDS patients in the U.S., and Pharming anticipates further updates on this progress soon.

Pharming is also working actively with regulatory agencies worldwide to make Joenja® available in as many markets as possible. Recently, Joenja® received regulatory approval in Israel, another testament to its clinical benefits. Additionally, Pharming has completed enrollment in a clinical trial for leniolisib in children aged 4 to 11, with the aim of securing pediatric approval by 2025.

Pharming also intends to expand the market for leniolisib beyond APDS to treat larger Primary Immunodeficiency (PID) disorders linked to PI3Kẟ signaling. The company is preparing for a Phase II proof-of-concept clinical trial targeting these PID disorders.

In the financial realm, Pharming completed a refinancing initiative by issuing €100 million in new convertible bonds due in 2029, enabling the company to repurchase most of its €125 million convertible bonds due in 2025. This move strengthens Pharming’s financial position and provides flexibility for its business strategy.

Financial highlights for the first quarter show a gross profit increase of 23% to $47.2 million, primarily due to revenue growth, partially offset by inventory impairments. Operating losses amounted to $16.3 million, up from $13.7 million in the first quarter of 2023, mainly due to increased operating expenses related to the launch of Joenja® and preparation for leniolisib's launch outside the U.S.

Pharming reported a net loss of $12.4 million, slightly higher than the $12.2 million loss in the first quarter of 2023. This was due to increased revenues offset by higher operating expenses. The company's cash and equivalents stood at $203.5 million at the end of the quarter, down from $215 million at the end of the previous quarter.

Looking ahead, Pharming aims to achieve total revenues between $280 million and $295 million for 2024, supported by continued efforts to diagnose more APDS patients, increase leniolisib revenues outside the U.S., complete clinical trials for regulatory filings, and expand the leniolisib market for additional PID indications. The company remains focused on potential acquisitions and in-licensing opportunities in rare diseases to drive future growth.