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Pharming Group (PHAR)

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Recent press releases and 8-K filings for PHAR.

Pharming Reports Strong 2025 Performance and Issues 2026 Financial Guidance
PHAR
Guidance Update
Revenue Acceleration/Inflection
New Projects/Investments
  • Pharming announced preliminary 2025 revenue of approximately $376 million, marking a 27% increase over 2024, with RUCONEST contributing $318 million and Joenja $58 million.
  • For 2026, the company projects total revenues between $405 million and $425 million, an 8%-13% growth over 2025, driven by mid-single-digit growth for RUCONEST and significant acceleration for Joenja.
  • The pipeline includes leniolisib, with two Phase II study readouts anticipated in H2 2026, and napazimone (KL1333) for primary mitochondrial disease, which passed futility analysis in its pivotal Phase II study and expects enrollment completion in 2026 with a readout in late 2027.
  • Pharming concluded 2025 with $181 million in cash and marketable securities and forecasts 2026 operating expenses between $300 million and $335 million, including over $60 million for incremental R&D investments.
3 hours ago
Pharming Provides 2026 Financial Guidance and Pipeline Updates
PHAR
Guidance Update
Revenue Acceleration/Inflection
New Projects/Investments
  • Pharming reported preliminary 2025 revenue of approximately $376 million, a 27% increase over 2024, driven by Reconnect revenue of $318 million (26% growth) and Joenja revenue of $58 million (29% growth).
  • For 2026, the company expects total revenues between $405 million and $425 million, representing 8%-13% full-year growth over 2025, with Joenja growth accelerating by approximately 10 percentage points higher than in 2025.
  • The company anticipates 2026 operating expenses between $300 million and $335 million, including over $60 million in incremental R&D investments, and projects a 90% gross margin.
  • Pharming has two leniolisib Phase 2 studies for PIDs with immune dysregulation on track for readouts in the second half of 2026, and enrollment for the napazimod pivotal Phase 2 study for primary mitochondrial disease is expected to complete in 2026 with a readout in late 2027.
4 hours ago
Pharming Provides 2026 Financial Guidance and Pipeline Updates at Investor Day
PHAR
Guidance Update
Revenue Acceleration/Inflection
New Projects/Investments
  • Pharming reported preliminary 2025 revenue of approximately $376 million, marking a 27% increase over 2024, with Reconnect revenues at $318 million and Joenja at $58 million.
  • The company issued 2026 revenue guidance of $405 million to $425 million, projecting 8%-13% growth over 2025, driven by anticipated accelerating Joenja growth and continued Reconnect growth.
  • Key pipeline updates include leniolisib, with two phase 2 study readouts expected in H2 2026, and napazimod (KL1333), which is in a pivotal phase 2 (FALCON study) that passed a futility analysis and is projected to complete enrollment in 2026 for a readout in late 2027.
  • Pharming aims to become a leading global rare disease company, with napazimod positioned as a potential first standard of care for primary mitochondrial disease, targeting an addressable patient population of over 30,000 in key markets.
5 hours ago
Pharming Group Announces 2026 Financial Guidance and Pipeline Updates
PHAR
Guidance Update
New Projects/Investments
Revenue Acceleration/Inflection
  • Pharming Group N.V. announced its 2026 financial guidance on February 3, 2026, projecting total revenues between US$405 million and US$425 million (8% to 13% growth) and total operating expenses between US$330 million and US$335 million.
  • The company highlighted its rare disease pipeline, with leniolisib Phase II trial data expected in the second half of 2026 and the pivotal FALCON clinical trial for napazimone (KL1333) on track for a readout in 2027.
11 hours ago
Pharming Group Receives FDA Complete Response Letter for Pediatric Joenja sNDA
PHAR
Product Launch
New Projects/Investments
  • Pharming Group N.V. received a Complete Response Letter (CRL) from the U.S. FDA on February 1, 2026, for its supplemental New Drug Application (sNDA) for Joenja® (leniolisib) as a treatment for children aged 4 to 11 years with Activated Phosphoinositide 3-Kinase Delta Syndrome (APDS).
  • The FDA's concerns include the potential for underexposure in lower weight pediatric patients, requiring additional pharmacokinetic data, and an issue with one of the analytical methods used for production batch testing.
  • Pharming plans to work closely with the FDA to address these issues, including requesting a Type A meeting, to determine the next steps for resubmission.
  • The existing U.S. FDA approval for Joenja for patients aged 12 years and older remains unaffected by this regulatory action.
1 day ago
Pharming Group N.V. Reports Preliminary 2025 Revenues and Announces Investor Day
PHAR
Earnings
Guidance Update
Revenue Acceleration/Inflection
  • Pharming Group N.V. announced preliminary, unaudited total 2025 revenues are estimated to be approximately US$376 million.
  • This revenue figure exceeds the upwardly revised guidance range of US$365 to US$375 million provided in November 2025, representing approximately 27% growth versus 2024.
  • The strong performance is attributed to continued growth of RUCONEST® and rising demand for Joenja®, driven by U.S. patient uptake and geographic expansion.
  • Full-year 2025 operating expenses are expected to be within the previously communicated range of US$304 to US$308 million.
  • The company will host a virtual Investor Day on February 3, 2026, to provide updates on its pipeline and present its 2026 financial guidance.
Jan 8, 2026, 11:29 AM
Pharming Reports Strong Q3 2025 Results, Raises Guidance, and Details Growth Catalysts
PHAR
Guidance Update
Revenue Acceleration/Inflection
M&A
  • Pharming reported strong Q3 2025 results and raised its revenue guidance, driven by the continued growth of its two assets, RUCONEST and Joenja, which grew 29% in Q4 2024 year on year and 35%, respectively.
  • The company anticipates significant growth for Joenja, expecting FDA label expansion for the pediatric APDS population by end of January 2026, which could add 30% to its potential, and projects the reclassification of approximately 250 VUS patients over time, increasing APDS potential by 50%.
  • Pharming acquired Abliva, adding KL1333 for primary mitochondrial disease to its pipeline, an asset with more than a billion-dollar potential that is currently in registrational phase 2 trials and has undergone a positive futility analysis.
  • To optimize capital allocation and drive value, Pharming has cut 20% of its G&A headcounts and appointed Kenneth Lenertz as its new CFO.
Nov 19, 2025, 10:00 AM
Pharming Reports Strong Q3, Highlights Growth Drivers for RUCONEST and Joenja, and Discusses KL1333 Acquisition
PHAR
Guidance Update
Revenue Acceleration/Inflection
M&A
  • Pharming reported strong Q3 results and raised revenue guidance, driven by the continued double-digit growth of its two assets, RUCONEST and Joenja.
  • RUCONEST grew 29% in Q4 year-on-year, maintaining its position for severe HAE patients, while the company exited non-U.S. markets due to financial unsustainability.
  • Joenja grew 35% in Q4 year-on-year and is projected to become a billion-dollar drug, with significant growth opportunities including pediatric indication expansion (expected by end of January) and reclassification of 250 VUS patients.
  • Pharming acquired Abliva for KL1333, a drug for Primary Mitochondrial Disease (PMD) with billion-dollar potential currently in registrational Phase II trials, which has undergone a positive futility analysis.
  • The company is focused on optimal capital allocation, including a 20% cut in G&A headcounts, and recently attracted a new CFO, Kenneth Lynard.
Nov 19, 2025, 10:00 AM
Pharming Reports Strong Q3 Results, Raises Guidance, and Outlines Growth Strategies
PHAR
Guidance Update
Revenue Acceleration/Inflection
New Projects/Investments
  • Pharming reported strong third-quarter results and raised its revenue guidance, driven by RUCONEST growing 29% year-on-year in Q4 and Joenja growing 35%.
  • The company is focused on Joenja's high-growth potential, with expected FDA approval for pediatric expansion by the end of January, and the reclassification of VUS patients projected to increase APDS potential by 50%.
  • Pharming acquired KL1333 for primary mitochondrial disease, a registrational Phase 2 asset with billion-dollar potential that has undergone a positive futility analysis.
  • To optimize capital allocation, Pharming cut 20% of its G&A headcounts and appointed Kenneth Lenertz as the new CFO.
Nov 19, 2025, 10:00 AM
Pharming Group N.V. Reports Strong Q3 2025 Results and Raises Full-Year Revenue Guidance
PHAR
Earnings
Guidance Update
Product Launch
  • Pharming Group N.V. reported Q3 2025 total revenues of $97.3 million, a 30% increase year-over-year, with operating profit reaching $16.0 million.
  • The company raised its full-year 2025 total revenue guidance to $365-$375 million from the previous $335-$350 million, projecting 23%-26% growth.
  • Both commercial assets contributed significantly, with Ruconest revenue up 29% to $82 million and Joenja revenue increasing 35% to $15.1 million in Q3 2025.
  • The FDA granted priority review for Joenja's label expansion to 4- to 11-year-old children, with an approval date set for January 31, 2026, which is expected to be a significant growth driver.
  • Pharming is optimizing capital allocation through G&A headcount reductions and plans to complete the withdrawal of Ruconest from some European markets by the first half of 2026 due to financial sustainability.
Nov 6, 2025, 12:30 PM