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Pharming N.V.(PHAR) - 2025 Q3 - Earnings Call Presentation
2025-11-06 12:30
Financial Performance - Total revenues for Q3 2025 increased by 30% to US$97.3 million[13, 43] - RUCONEST® revenues in Q3 2025 reached US$82.2 million[13, 22] - Joenja® revenues in Q3 2025 amounted to US$15.1 million[13, 27] - Operating profit significantly grew to US$16.0 million in Q3 2025[13, 43] - Cash flow from operations was US$32 million in Q3 2025[14, 41] - Total revenues for 9M 2025 grew 33% to US$269.6 million[44, 45] Business Updates and Outlook - 2025 revenue guidance raised to US$365-375 million due to strong RUCONEST® performance[14, 51] - RUCONEST® U S volume growth was +24% in 3Q25 and +28% in 9M25[22] - There are 116 US patients on Joenja® representing a +25% increase vs 3Q24[27] - FDA filing for Leniolisib for 4-11 year old APDS patients is based on Phase III data and has a PDUFA date of Jan 31, 2026[28]
Pharming N.V.(PHAR) - 2025 Q3 - Quarterly Report
2025-11-06 11:04
For the Month of November 2025 Commission File Number: 001-39822 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 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): ☐ Pharming Group N.V. (Exact Name of Registrant as Specified in Its Charter) Darwinweg 24 2333 CR Leiden The Netherlands (Address of ...
Pharming Group reports third quarter 2025 financial results with significant growth in revenue, profitability and cash flow
Globenewswire· 2025-11-06 06:00
Core Insights - Pharming Group N.V. reported a strong financial performance for Q3 2025, with total revenues increasing by 30% to US$97.3 million compared to Q3 2024, driven by growth in both RUCONEST® and Joenja® [9][30][31] Financial Performance - Total revenues for Q3 2025 reached US$97.3 million, a 30% increase from US$74.8 million in Q3 2024 [30] - RUCONEST® revenue increased by 29% to US$82.2 million, reflecting sustained growth in patients and prescribers [9][10] - Joenja® revenue grew by 35% to US$15.1 million, driven by a significant increase in patients on paid therapy [13][31] - Operating profit surged by 285% to US$15.8 million compared to US$4.1 million in Q3 2024 [32] - The company generated US$32 million in cash flow from operations during the quarter [34] Strategic Developments - Pharming announced a significant reduction in general and administrative headcount to optimize capital deployment towards high-growth initiatives [5][23] - The company is focusing on expanding its pipeline, particularly for leniolisib in broader primary immunodeficiency populations and addressing unmet needs in primary mitochondrial disease with KL1333 [4][5] Market Position and Outlook - The company raised its full-year revenue guidance to between US$365 million and US$375 million, up from the previous range of US$335 million to US$350 million [6][44] - The U.S. market contributed 89% of Q3 revenue, while the EU and Rest of World contributed 11% [14] - Pharming plans to launch a pediatric formulation of leniolisib for children aged 4 to 11 years, with FDA priority review expected by January 2026 [20][44] Organizational Changes - Leverne Marsh has been appointed as Chief Commercial Officer, effective January 1, 2026, succeeding Stephen Toor [7][24] - Kenneth Lynard was appointed as Chief Financial Officer, effective October 1, 2025, enhancing the company's financial leadership [22] Corporate Highlights - Pharming was promoted from the Euronext AScX® to the AMX® index, reflecting its growing market capitalization and trading activity [25] - The company is working on options to mitigate the impact of recently announced U.S. tariffs, although it does not expect a material impact on its business [26]
Pharming Group to participate in Fireside Chat at Jefferies Global Healthcare Conference in London
Globenewswire· 2025-10-30 07:00
Core Insights - Pharming Group N.V. will participate in the Jefferies Global Healthcare Conference in London from November 17-20, 2025 [1] - CEO Fabrice Chouraqui will engage in a Fireside Chat Q&A session on November 19 at 10:00 GMT/11:00 CET [2] - Pharming is a global biopharmaceutical company focused on developing innovative medicines for rare and life-threatening diseases [3] Company Information - Pharming is headquartered in Leiden, the Netherlands, with a significant number of employees based in the U.S. [3] - The company is dedicated to transforming the lives of patients through a portfolio of small molecules and biologics [3] Contact Information - Investor Relations can be reached at investor@pharming.com for inquiries regarding the conference or to schedule meetings [2][5] - Media Relations contacts include Saskia Mehring for global inquiries and Ethan Metelenis for U.S. inquiries [5]
Pharming Group to report third quarter 2025 financial results and provide business update on November 6
Globenewswire· 2025-10-23 06:00
Core Insights - Pharming Group N.V. will report its preliminary (unaudited) financial results for the third quarter of 2025 on November 6, 2025, along with a business update [1] - A conference call and webcast for analysts and investors will take place on the same day at 13:30 CET/07:30 am ET [1] Conference Call Details - Participants must register in advance to join the conference call or watch the live webcast [2] - Registration for the conference call can be done through a provided link, after which dial-in information and a unique PIN will be sent to attendees [3] - The webcast will also be available on the Pharming website, with a replay accessible shortly after the event [4] Company Overview - Pharming Group N.V. is a global biopharmaceutical company focused on developing and commercializing innovative medicines for patients with rare and life-threatening diseases [5] - The company is headquartered in Leiden, the Netherlands, with a significant number of employees based in the U.S. [5]
Pharming Group announces presentations at 2025 ACAAI Annual Scientific Meeting showcasing new data across rare disease portfolio
Globenewswire· 2025-10-20 06:00
Core Insights - Pharming Group N.V. announced that 12 abstracts have been accepted for presentation at the ACAAI 2025 Annual Scientific Meeting, highlighting the company's commitment to advancing research in hereditary angioedema (HAE) and activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) [1][3]. Summary by Category Clinical Data - Five posters will present positive clinical, economic, and comparative data for RUCONEST® in the treatment of on-demand hereditary angioedema (HAE) [2]. - Seven posters will focus on the real-world effectiveness of Joenja® (leniolisib), including results from the Phase III pediatric trial and insights into the burden faced by pediatric patients and caregivers dealing with APDS [2]. Presentation Details - Specific studies include an indirect treatment comparison of recombinant C1 inhibitor and Sebetralstat for HAE on-demand therapy, cost-effectiveness analysis, and patient-reported outcome measures across clinical trials [4][5]. - The presentations are scheduled for various dates and times during the ACAAI meeting, with ePosters accessible online for registered attendees [5]. Company Overview - Pharming Group is a biopharmaceutical company focused on developing innovative medicines for rare diseases, with a significant presence in both the U.S. and Europe [14].
Pharming Group provides update on previously announced G&A expense reduction plan
Globenewswire· 2025-10-06 15:35
Core Insights - Pharming Group N.V. is implementing an organizational restructuring to accelerate growth and optimize capital allocation by reducing general and administrative expenses [1][2] Restructuring Details - The restructuring involves a redesign of the organizational structure and a 20% net reduction in non-commercial and non-medical headcount, primarily at the Netherlands headquarters [2] - The company aims to reduce total G&A expenses by 15%, equating to approximately US$10 million annually, with one-time restructuring costs expected to be around $7 million in Q4 2025 [2] Consultation Process - Pharming has engaged with its Dutch Works Council over the past several months to discuss the organizational changes in compliance with Dutch labor law [3] Company Overview - Pharming Group N.V. is a global biopharmaceutical company focused on developing and commercializing innovative medicines for patients with rare and life-threatening diseases [4]
Pharming Group announces U.S. FDA acceptance and Priority Review of supplemental New Drug Application for leniolisib in children with APDS aged 4 to 11 years
Globenewswire· 2025-10-01 05:00
Core Viewpoint - Pharming Group N.V. announced that the FDA has accepted its supplemental New Drug Application for leniolisib, aimed at treating children aged 4 to 11 years with activated phosphoinositide 3-kinase delta syndrome (APDS), with a target action date of January 31, 2026 [1][7]. Group 1: FDA Approval Process - The supplemental New Drug Application is based on positive results from a Phase III study showing improvements in lymphadenopathy and naïve B cells over 12 weeks [2]. - The FDA has granted Priority Review status to the application, indicating that the treatment could offer significant improvements in effectiveness or safety for serious conditions [3]. Group 2: Disease Background - APDS is a rare primary immunodeficiency characterized by immune dysregulation and recurrent infections, often leading to severe complications such as lung damage and lymphoma [5]. - The condition affects approximately 1 to 2 individuals per million globally, and patients often experience a median diagnostic delay of 7 years [5]. Group 3: Treatment Details - Leniolisib is an oral PI3Kδ inhibitor, previously approved for patients aged 12 and older, and is the first targeted treatment for APDS [6][4]. - The drug has shown statistically significant improvements in clinical trials, and its safety and tolerability have been supported by long-term data [6]. Group 4: Future Developments - Leniolisib is currently under regulatory review in multiple regions, including the European Economic Area, Japan, and Canada, for its use in APDS [6]. - The company is also evaluating leniolisib in additional clinical trials for other primary immunodeficiencies with immune dysregulation [8].
Concentrix Posts Downbeat Earnings, Joins Legacy Education, Kingsoft Cloud And Other Big Stocks Moving Lower In Friday's Pre-Market Session - Apellis Pharmaceuticals (NASDAQ:APLS), Concentrix (NASDAQ:
Benzinga· 2025-09-26 12:04
Core Insights - U.S. stock futures showed mixed results, with Dow futures up approximately 0.1% on Friday [1] - Concentrix Corporation reported disappointing third-quarter adjusted EPS results and lowered its FY25 adjusted EPS guidance, leading to a significant drop in its share price [1][2] Concentrix Corporation - Concentrix reported quarterly earnings of $2.78 per share, missing the Street estimate of $2.86 [2] - Quarterly revenue was $2.48 billion, surpassing the analyst consensus estimate of $2.45 billion [2] - The company reduced its fiscal 2025 adjusted EPS guidance to a range of $11.11 to $11.23, below the previous estimate of $11.69 [2] - Concentrix raised its revenue outlook for FY25 to between $9.79 billion and $9.82 billion, compared to the prior estimate of $9.77 billion [2] - Shares of Concentrix fell 20.5% to $43.73 in pre-market trading following the earnings report [2] Other Stocks - DarioHealth Corp. saw a decline of 18.9% to $11.10 in pre-market trading after a significant increase the previous day [5] - Legacy Education Inc. dropped 13.3% to $10.68 after reporting worse-than-expected fourth-quarter EPS results [5] - Apellis Pharmaceuticals, Inc. decreased by 9.5% to $20.12 in pre-market trading [5] - Pharming Group N.V. fell 9.1% to $13.45, while Kingsoft Cloud Holdings Limited declined 7.5% to $16.15 after announcing a new share offering [5] - Other notable declines included IREN Limited down 7.4% to $42.85 and LuxExperience B.V. down 6.3% to $7.89 [5]
CXO行业深度跟踪报告:CDMO景气度持续,CRO拐点可期
Xinda Securities· 2025-09-26 06:04
Investment Rating - The report maintains a "Positive" investment rating for the pharmaceutical and biotechnology industry [2] Core Insights - The CXO industry is experiencing a recovery in market conditions, driven by improvements in supply-demand dynamics and a rebound in financing activities for innovative drugs [3][4] - The CDMO sector continues to show high growth potential, with leading companies improving their performance and expanding into emerging markets [5][6] - The CRO sector is approaching a turning point, with signs of demand recovery and improved order conditions [6][7] Summary by Sections CXO Industry Overview - The CXO industry operates on a "water seller" business model, closely tied to the financing of the biopharmaceutical sector. In the first eight months of 2025, overseas innovative drug financing reached $22.6 billion, a year-on-year decline of approximately 36%, while domestic innovative drug financing amounted to $7.75 billion, a year-on-year increase of about 89% [3][31] - The leading companies in the CXO sector are expected to enter an expansion phase as demand recovers, while smaller companies may face increased competition and exit the market [4][44] CDMO Sector - CDMO leading companies have begun to see marginal improvements in performance since Q4 2024, attributed to high overseas revenue and a unique business model that supports project pipeline growth [5][46] - The order situation for CDMO companies has improved significantly, with notable increases in backlogged orders for major players like WuXi AppTec and WuXi Biologics [49][50] - The CDMO business model is characterized by strong customer retention and project scalability, allowing for sustained growth despite challenges in new project signings [52] CRO Sector - The CRO sector is witnessing a divergence in performance among leading companies, with some starting to recover. The overall order situation has shown improvement, indicating a potential demand revival [6][22] - The price increase of experimental monkeys suggests a forthcoming recovery in preclinical CRO demand, highlighting the importance of resource availability for leading CRO companies [6][24] - The integration of AI in drug development processes is expected to enhance efficiency and reduce costs, with many domestic CRO leaders already adopting AI technologies [7][18] Recommended Companies - The report suggests focusing on key players in the CXO sector, including WuXi AppTec, WuXi Biologics, WuXi AppTec, and others, which are positioned well for growth based on their business characteristics and market trends [8][10]