Pharming N.V.(PHAR)
Search documents
Pharming Group reports second quarter and first half 2025 financial results and provides business update
Globenewswire· 2025-07-31 05:00
Core Insights - Pharming Group N.V. reported a strong second quarter with a total revenue growth of 26% and positive operating profit, driven by significant growth in RUCONEST® and Joenja® [2][7][29] - The company raised its full-year revenue guidance to between US$335 million and US$350 million, up from the previous range of US$325 million to US$340 million [7][44] Financial Performance - Total revenues for Q2 2025 increased by 26% to US$93.2 million compared to Q2 2024, with RUCONEST® revenue growing by 28% to US$80.4 million and Joenja® revenue increasing by 15% to US$12.8 million [7][29][30] - Operating profit for Q2 2025 was US$10.8 million, a significant improvement from a loss of US$3.1 million in Q2 2024 [7][31] - For the first half of 2025, total revenues rose by 33% to US$172.3 million, with RUCONEST® revenues up 37% to US$149.0 million [35][36] Product Development and Market Expansion - Joenja® is showing accelerated uptake, with patient growth in the first half of 2025 surpassing the total for all of 2024 [2][11] - A recent study published in the journal Cell suggests that the prevalence of APDS may be up to 100 times higher than previously estimated, potentially expanding Joenja®'s addressable patient population [3][16] - The company launched Joenja® in the U.K. and submitted a regulatory filing for leniolisib in Japan, indicating ongoing efforts to expand market access [4][20] Strategic Initiatives - Pharming is working on mitigating the impact of U.S. tariffs, although it does not expect a material impact on its business [5] - The company is on track to reduce general and administrative expenses by 15% or US$10 million to optimize capital allocation for sustainable growth [26] - The acquisition of Abliva AB was completed, increasing Pharming's ownership to 100% [25] Cash Flow and Financial Position - Cash and marketable securities increased to US$130.8 million at the end of Q2 2025, up from US$108.9 million at the end of Q1 2025, primarily due to cash generated from operations [7][34] - The company reported a net profit of US$4.6 million for Q2 2025, compared to a net loss of US$1.2 million in Q2 2024 [33]
Best Momentum Stocks to Buy for July 17th
ZACKS· 2025-07-17 15:01
Group 1: ProKidney Corp. (PROK) - ProKidney is a clinical-stage biotechnology company with a Zacks Rank 1 [1] - The Zacks Consensus Estimate for its current year earnings increased by 5.8% over the last 60 days [1] - ProKidney's shares gained 371.7% over the last three months, significantly outperforming the S&P 500's advance of 18.2% [1] - The company has a Momentum Score of A [1] Group 2: Roku, Inc. (ROKU) - Roku operates a TV streaming platform and holds a Zacks Rank 1 [2] - The Zacks Consensus Estimate for its current year earnings increased by 5.3% over the last 60 days [2] - Roku's shares gained 55.4% over the last three months, also outperforming the S&P 500's advance of 18.2% [2] - The company has a Momentum Score of B [2] Group 3: Pharming Group N.V. (PHAR) - Pharming is a biopharmaceutical company with a Zacks Rank 1 [3] - The Zacks Consensus Estimate for its current year earnings increased nearly 7% over the last 60 days [3] - Pharming's shares gained 26.6% over the last three months, again outperforming the S&P 500's advance of 18.2% [3] - The company has a Momentum Score of B [3]
Pharming Group to report second quarter and first half 2025 financial results and provide business update on July 31
Globenewswire· 2025-07-17 06:00
Company Overview - Pharming Group N.V. is a global biopharmaceutical company focused on transforming the lives of patients with rare, debilitating, and life-threatening diseases [5] - The company is involved in the commercialization and development of a portfolio of innovative medicines, including small molecules and biologics [5] - Pharming is headquartered in Leiden, the Netherlands, and operates in over 30 markets across North America, Europe, the Middle East, Africa, and Asia-Pacific [5] Upcoming Financial Results - Pharming will report its preliminary (unaudited) financial results for the second quarter and first half of 2025 on July 31, 2025 [1] - A business update will also be provided during the same announcement [1] - Management will host a conference call and webcast for analysts and investors at 13:30 CEST/07:30 am EDT on the same day [1]
Pharming N.V.(PHAR) - 2025 Q1 - Quarterly Report
2025-05-08 10:59
Pharming Group N.V. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of May 2025 Commission File Number: 001-39822 (Exact Name of Registrant as Specified in Its Charter) Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐ Indicate by check mark if the registrant is submitting the Fo ...
Pharming Group announces upcoming presentations at the 2025 Annual Meeting of the Clinical Immunology Society (CIS)
Newsfilter· 2025-04-25 13:00
Core Insights - Pharming Group N.V. is presenting Phase III clinical data for leniolisib, targeting pediatric patients aged 4-11 years with activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) at the 2025 Annual Meeting of the Clinical Immunology Society [1][2] Presentations - The presentation titled "Primary and Safety Outcomes of a Phase 3 Open-Label, Single-Arm, 12-Week Study of Treatment With PI3Kδ Inhibitor Leniolisib in Pediatric Patients Aged 4-11 Years With Activated PI3Kδ Syndrome (APDS)" will be led by Dr. Shanmuganathan Chandrakasan on May 2, 2025 [2] - Additional presentations include a systematic literature review on immune dysregulation in common variable immunodeficiency and insights into APDS from patient perspectives [2] About Leniolisib - Leniolisib is an oral small molecule PI3Kδ inhibitor approved in several countries as the first targeted treatment for APDS in patients aged 12 and older [3] - The drug has shown statistically significant improvement in co-primary endpoints in a Phase III clinical trial, indicating a favorable impact on immune dysregulation [3] - Leniolisib is under regulatory review in the European Economic Area, Canada, and other regions, with plans for approval in Japan [3] About Pharming Group N.V. - Pharming Group N.V. is a global biopharmaceutical company focused on developing innovative medicines for rare and life-threatening diseases [4] - The company is headquartered in Leiden, the Netherlands, and operates in over 30 markets worldwide [4]
Pharming receives positive recommendation from NICE for Joenja®▼(leniolisib) as a treatment for APDS
Newsfilter· 2025-04-23 07:30
Core Viewpoint - Pharming Group N.V. has received positive final guidance from the National Institute for Health and Care Excellence (NICE) for the reimbursement and use of Joenja® (leniolisib) in treating activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in patients aged 12 and older within the NHS in England and Wales [1][2][4] Group 1: NICE Recommendation and Clinical Data - The NICE recommendation is based on comprehensive data from a Phase III clinical trial that showed significant improvements in immune deficiency and dysregulation with leniolisib compared to placebo [2][4] - The Phase III trial results indicated sustained clinical improvements during long-term treatment in an open-label extension trial [2] Group 2: Impact on Patients and Healthcare - The NICE recommendation is viewed as a significant milestone for patients with APDS, enhancing treatment options and potentially improving their quality of life [3][4] - Joenja® is now available for use and funded in England through the Innovative Medicines Fund, with expected funding in Wales within three months [4] Group 3: About Joenja® and APDS - Joenja® is the first and only targeted treatment for APDS, an oral small molecule PI3Kδ inhibitor that addresses the underlying immune system issues associated with the condition [8] - APDS is a rare primary immunodeficiency affecting approximately 1 to 2 people per million worldwide, characterized by severe recurrent infections and immune dysregulation [6][7]
Pharming N.V.(PHAR) - 2024 Q4 - Annual Report
2025-04-03 10:10
[Form 6-K Report of Foreign Private Issuer (April 2025)](index=1&type=section&id=Form%206-K%20Report%20of%20Foreign%20Private%20Issuer%20(April%202025)) This Form 6-K report provides key announcements from a foreign private issuer in April 2025 [Announcement of 2024 Annual Report and Form 20-F Filing](index=3&type=section&id=Pharming%20Group%20announces%20the%20filing%20of%20its%202024%20Annual%20Report%20and%20Form%2020-F) Pharming Group N.V. announced the filing of its Annual Report for the year ended December 31, 2024, along with its Annual Report on Form 20-F with the U.S. Securities and Exchange Commission (SEC) - Pharming Group N.V. has filed its Annual Report for the year ended December 31, 2024[8](index=8&type=chunk) - The company also filed its Annual Report on Form 20-F with the U.S. SEC for the same period[9](index=9&type=chunk) - The reports are available on the Pharming.com website under the 'Investors' section and through the SEC website[8](index=8&type=chunk)[9](index=9&type=chunk) [About Pharming Group N.V.](index=3&type=section&id=About%20Pharming%20Group%20N.V.) Pharming Group N.V. is a global biopharmaceutical company headquartered in Leiden, the Netherlands, focusing on innovative medicines for rare and life-threatening diseases across over 30 markets - Pharming is a global biopharmaceutical company dedicated to treating patients with rare, debilitating, and life-threatening diseases[10](index=10&type=chunk) - The company's portfolio includes commercialized and developing innovative medicines, such as small molecules and biologics[10](index=10&type=chunk) - Headquartered in Leiden, the Netherlands, Pharming serves patients in over 30 markets worldwide[10](index=10&type=chunk) [Other Information](index=3&type=section&id=Other%20Information) This section discloses that the press release content may qualify as inside information under EU Market Abuse Regulation and provides contact details for investor and public relations - The press release may contain information that qualifies as 'inside information' within the meaning of Article 7(1) of the EU Market Abuse Regulation[12](index=12&type=chunk) - Contact details for investor relations, corporate communications, and public relations are provided for further inquiries[13](index=13&type=chunk)
Pharming N.V.(PHAR) - 2024 Q4 - Annual Report
2025-04-03 10:04
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF ...
Pharming Group announces first patient dosed in Phase II clinical trial of leniolisib for common variable immunodeficiency (CVID) with immune dysregulation
Newsfilter· 2025-03-20 06:00
Core Insights - Pharming Group N.V. has initiated a Phase II clinical trial for leniolisib targeting common variable immunodeficiency (CVID) patients with immune dysregulation, marking a significant step in addressing unmet medical needs in this patient population [1][4]. Group 1: Clinical Trial Details - The Phase II trial is a single-arm, open-label study involving approximately 20 patients aged 12 and older, focusing on safety, tolerability, pharmacokinetics, pharmacodynamics, and clinical efficacy of leniolisib in CVID patients [2]. - The trial specifically targets CVID patients exhibiting lymphoproliferation and at least one additional clinical manifestation of immune dysregulation, such as interstitial lung disease or autoimmune cytopenias [2][3]. - The lead investigator is Dr. Jocelyn Farmer, with clinical sites located in the US, UK, and EU [2]. Group 2: Disease Context and Unmet Needs - CVID is the largest group of symptomatic primary immunodeficiency patients, with about 50% experiencing autoimmune and lymphoproliferative complications due to immune dysregulation [3]. - Patients with CVID and immune dysregulation have an 11-fold increased mortality rate compared to those with infectious manifestations alone, highlighting the critical need for effective therapies [3]. - The global prevalence of CVID with immune dysregulation is estimated at approximately 39 patients per million [3]. Group 3: Leniolisib Overview - Leniolisib is an oral small molecule phosphoinositide 3-kinase delta (PI3Kδ) inhibitor, currently approved in the U.S. for treating activated phosphoinositide 3-kinase delta syndrome (APDS) [5][6]. - The drug has shown statistically significant improvement in clinical trials for APDS, and its safety and tolerability for long-term use have been supported by interim data [6]. - Leniolisib is under regulatory review in multiple regions, including the European Economic Area, Canada, and Australia, with plans for further approvals in Japan and South Korea [6]. Group 4: Company Background - Pharming Group N.V. is a global biopharmaceutical company focused on developing therapies for rare and life-threatening diseases, with a portfolio that includes protein replacement therapies and precision medicines [7]. - The company is headquartered in Leiden, the Netherlands, and operates in over 30 markets worldwide [7].
Pharming N.V.(PHAR) - 2024 Q4 - Earnings Call Transcript
2025-03-13 23:44
Financial Data and Key Metrics Changes - Full-year 2024 revenues increased by 21% to $297 million, exceeding guidance, with strong performance in Q4 [7][42] - Operating profit increased by $5.6 million, marking the second consecutive quarter of positive operating profit [43] - Net results shifted from a loss in Q4 2023 to a net profit in Q4 2024, with positive operating cash flow for the second quarter in a row [44] Business Line Data and Key Metrics Changes - RUCONEST revenue grew 11% to $252 million for the year, with a 9% increase in Q4, driven by new patient enrollments and prescriber base expansion [7][11] - Joenja revenue surged by 147% to $45 million in 2024, with a 65% increase in Q4 [9][12] Market Data and Key Metrics Changes - The prescriber base for RUCONEST increased by 11% and new patient enrollments rose by 24% [11] - Joenja's patient pipeline is expanding, with over 240 identified patients in the US, 40% of whom are on paid therapy [20] Company Strategy and Development Direction - The company aims to develop a leading global rare disease portfolio, leveraging a proven clinical development and commercial infrastructure [7] - The acquisition of Abliva is seen as a strategic move to enhance the company's pipeline and revenue potential [6][46] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in RUCONEST's continued growth despite increasing competition, citing its unique profile and strong patient experience [50][79] - The company anticipates total revenues for 2025 to be between $315 million and $335 million, reflecting continued growth in RUCONEST and Joenja [47] Other Important Information - The company is actively monitoring potential US tariffs on drugs and is taking steps to mitigate any impact on its supply chain [70] - The anticipated operating expenses related to the Abliva acquisition are estimated at $30 million for 2025, including $17 million for R&D [49][69] Q&A Session Summary Question: Insights on KL1333 and patient population - The addressable population for KL1333 is estimated at 30,000 patients in the US and Europe, focusing on those with specific mitochondrial DNA mutations [59] Question: Breakdown of patients in the expanded access program - Patients in the expanded access program are in multiple countries, with some on paid therapy through name patient programs, but specific numbers are not disclosed [63] Question: Recurring costs from Abliva acquisition - Of the $30 million anticipated OpEx from the Abliva acquisition, approximately $17 million will be for R&D, with the remainder being non-recurring costs [69] Question: Impact of potential US tariffs - The company is monitoring the situation regarding US tariffs and is exploring ways to minimize potential impacts on its supply chain [70] Question: RUCONEST's growth despite competition - Management believes RUCONEST will remain a treatment of choice due to its unique profile and strong patient experience, supported by market research [79][81] Question: Timeline for CVID trials - A Phase 2 study is anticipated for CVID, with a Phase 3 study likely required for registration [102] Question: Future expectations for CVID and fast-track designation - The company plans to explore fast-track designation options for CVID, given the severity of the disease [105]