Welcome to our dedicated page for Pharming Group N.V. SEC filings (Ticker: PHAR), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
The Pharming Group N.V. ADS (PHAR) SEC filings page on Stock Titan provides centralized access to the company’s U.S. regulatory disclosures, including Form 20‑F annual reports and Form 6‑K current reports. As a foreign private issuer listed on Nasdaq, Pharming uses these filings to communicate material information about its rare disease biopharmaceutical business, which centers on RUCONEST for hereditary angioedema (HAE) and Joenja (leniolisib) for activated phosphoinositide 3‑kinase delta syndrome (APDS).
Form 6‑K reports furnished by Pharming typically include press releases on quarterly and half‑year financial results, revenue trends for RUCONEST and Joenja, updates on clinical development of leniolisib in adult and pediatric APDS populations, and information on regulatory submissions and reviews in the U.S. and other jurisdictions. These filings may also cover organizational changes, index promotions on Euronext Amsterdam, and capital allocation or restructuring plans.
Form 20‑F annual reports (when available) provide a broader view of Pharming’s operations, risk factors, product portfolio, and financial statements, complementing the more event‑driven 6‑K disclosures. Together, these documents help investors understand how Pharming manages its rare disease pipeline, license agreements for leniolisib, and obligations such as milestones and royalties.
On Stock Titan, users can review Pharming’s SEC filings alongside AI‑generated highlights that summarize key points from lengthy documents, such as revenue drivers, segment performance, and major clinical or regulatory milestones. The filings page also surfaces insider and major shareholder transaction reports when available, allowing closer monitoring of ownership changes in PHAR. Real‑time updates from EDGAR ensure that new 6‑K or 20‑F submissions are quickly reflected, helping investors and analysts track Pharming’s evolving financial and clinical profile without manually searching the SEC’s database.
Pharming Group N.V. has scheduled its 2026 Annual General Meeting of Shareholders for Thursday, May 28, 2026 at 14:00 CET at the Corpus Congress Centre in Oegstgeest, the Netherlands, with a live webcast available.
The agenda includes appointing KPMG N.V. as external auditor for financial years 2026 through 2028, amendments to the remuneration policy for Non-Executive Directors, and renewal of Board authorizations to issue shares (including rights to acquire shares) and to repurchase shares. Meeting materials, including the Notice to Convene, Explanatory Notes, and Proxy, are available on Pharming’s website under Investors/Shareholder Meetings.
Pharming Group N.V. has filed Amendment No. 1 to its Form 20-F mainly to correct and re-file the CEO and CFO Section 906 certifications, which previously referenced an incorrect fiscal period. The amendment also re-files updated Section 302 certifications and a renewed Deloitte Accountants B.V. consent.
All other disclosures from the original Form 20-F for the year ended December 31, 2025 remain unchanged, including financial statements prepared under IFRS and extensive risk factors. These risks highlight the company’s heavy reliance on U.S. RUCONEST® sales and growing, but newer, Joenja® revenues, strong customer concentration with two U.S. specialty pharmacies, and significant competitive, regulatory, manufacturing, and intellectual property uncertainties.
Pharming Group N.V. has filed its 2025 Annual Report for the year ended December 31, 2025. The report is available via annualreport.pharming.com and the Investors/Financial documents section of the company’s website.
The company has also filed its 2025 Annual Report on Form 20-F with the U.S. SEC, which can be accessed through the Investors/SEC filings section on Pharming.com and the SEC website.
Pharming Group N.V. filed its Form 20-F annual report for the year ended December 31, 2025, outlining its rare disease business focused on RUCONEST® for hereditary angioedema and Joenja® (leniolisib) for APDS. RUCONEST® generated about 85% of 2025 revenues, highlighting heavy dependence on a single product and the U.S. market.
The report describes Joenja’s recent approvals in the U.S., U.K., Japan, Australia and Israel, together with extensive forward-looking statements on expanding indications and geographies. Key risks include intense competition in HAE, potential new gene and oral therapies, post-approval safety findings for Joenja®, reliance on a few specialty pharmacies, third‑party manufacturers and CROs, cyber threats, regulatory and reimbursement pressures, and challenges protecting patents. Pharming had 701,680,440 ordinary shares outstanding as of December 31, 2025.
Pharming Group N.V. reported that the European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive opinion recommending EU marketing authorization for Joenja (leniolisib) to treat activated phosphoinositide 3-kinase delta syndrome (APDS) in patients aged 12 and older. A final European Commission decision is expected in Q2 2026. If approved, Joenja would become the first authorized APDS treatment in the European Union, with a centralized authorization covering all EU Member States plus Norway, Iceland and Liechtenstein. The recommendation is based on a Phase II/III placebo-controlled trial in 31 patients and supporting long-term extension data in 37 patients, showing statistically significant improvements in immune dysregulation and immunodeficiency, alongside a favorable safety profile. Joenja is already approved for APDS in the United States, the United Kingdom and several other markets.
Pharming Group N.V. reports that Japan’s Ministry of Health, Labour and Welfare has approved Joenja (leniolisib) for activated PI3K delta syndrome (APDS) in adults and children aged 4 years and older. Joenja becomes the first treatment approved in Japan specifically for APDS and the first worldwide to cover children aged 4 to 11 with the disease.
The approval is based on positive Phase III data from multinational and Japanese studies in patients 12 years and older and a multinational pediatric study in children 4 to 11 years, showing reduced lymphadenopathy and increased naïve B cells. Under an agreement with Pharming, OrphanPacific serves as Marketing Authorization Holder in Japan and will handle supply and distribution. Launch is expected after agreement on National Health Insurance drug pricing. Joenja is already approved for APDS patients 12 and older in the U.S., U.K., Australia and Israel.
Pharming Group N.V. reports preliminary 2025 results with total revenues of US$376.1 million, up 27% from 2024, driven by growth in RUCONEST® and Joenja®.
The company swung from an operating loss of US$8.6 million to an operating profit of US$25.8 million, and from a net loss of US$11.8 million to a net profit of US$2.5 million. Net cash flow from operations was US$54.7 million, lifting total cash, restricted cash and marketable securities to US$181.1 million at year-end.
RUCONEST® full-year revenue rose 26% to US$317.9 million, while Joenja® revenue increased 29% to US$58.2 million, supported by a 25% rise in U.S. patients on paid therapy. For 2026, Pharming guides to total revenues of US$405–425 million (8–13% growth) and higher operating expenses as it advances leniolisib and napazimone (KL1333). Regulatory progress includes expected decisions on leniolisib in the EU, Japan and Canada, although the FDA issued a Complete Response Letter for the U.S. pediatric sNDA requiring additional data.
Pharming Group N.V. issued 2026 financial guidance and highlighted its rare disease pipeline at a virtual Investor Day. The company expects total revenues between US$405 million and US$425 million, implying 8% to 13% growth, driven by Joenja and continued contribution from RUCONEST.
Total operating expenses are guided to US$330 million to US$335 million, mainly reflecting higher research and development spending for ongoing Phase II trials of leniolisib and the pivotal FALCON trial of napazimone (KL1333). Management presented leniolisib’s expansion into broader primary immunodeficiency and CVID populations, with top-line Phase II data expected in the second half of 2026, and confirmed that the napazimone FALCON trial for mtDNA‑driven mitochondrial disease remains on track for a 2027 readout.
Pharming Group N.V. reports that the U.S. FDA has issued a Complete Response Letter to its supplemental New Drug Application for Joenja (leniolisib) in children aged 4 to 11 years with APDS, a rare primary immunodeficiency.
The FDA is concerned about potential underexposure in lower weight pediatric patients and has requested additional pharmacokinetic data to reassess dosing, along with clarification on an analytical method used in production batch testing. Pharming plans to request a Type A meeting and work with the FDA on resubmission. Joenja’s existing U.S. approval for APDS in patients 12 years and older remains unchanged.
Pharming Group N.V. reported preliminary, unaudited full-year 2025 revenues of approximately US$376 million, above its upwardly revised guidance range of US$365–375 million and about 27% growth versus 2024. Management attributes this performance to continued growth of RUCONEST® and strong uptake of Joenja®, especially from U.S. patients and broader geographic expansion. Full-year 2025 operating expenses are expected to land within the previously communicated range of US$304–308 million, reflecting cost discipline.
The company plans to host a virtual Investor Day on February 3, 2026, where it will give pipeline updates on leniolisib in Phase II proof-of-concept trials for primary immunodeficiencies, including CVID with immune dysregulation, and on KL1333 in the pivotal FALCON study for mtDNA-driven mitochondrial disease. Pharming also intends to present its 2026 financial guidance and report full fourth quarter and full-year 2025 results on March 12, 2026.