Latest news with #JazzPharmaceuticals


Business Insider
2 days ago
- Business
- Business Insider
Jazz Pharmaceuticals presents late-breaking phase 4 data showcasing Xywav
Jazz Pharmaceuticals (JAZZ) 'announced late-breaking Phase 4 data evaluating treatment benefits of Xywav oral solution in people with narcolepsy. These results are two of Jazz's four late-breaking abstracts presented today as oral presentations at SLEEP 2025. The four late-breaking abstracts, selected for their scientific quality and innovation, comprise all industry-sponsored late-breaking oral presentations selected by the Associated Professional Sleep Societies. Xywav is the only low-sodium oxybate approved by the U.S. Food and Drug Administration for the treatment of cataplexy or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy and for adults with idiopathic hypersomnia. The Xywav label recommends a nightly dose of 6-9 grams per night.' Confident Investing Starts Here:
Yahoo
2 days ago
- Business
- Yahoo
HER2+ Gastric Cancer (including GEJ) Market to Increase at a Remarkable Growth Rate of 13% During the Study Period (2020-2034)
The overall HER2+ gastric cancer market is projected to grow, driven by increasing biomarker testing, better patient selection, and continued advancements in HER2-targeted ADCs, bispecific antibodies, and novel immune-based approaches. Additionally, the launch of therapies such as Zanidatamab (Jazz Pharmaceuticals), Rilvegostomig (AstraZeneca), Evorpacept (ALX Oncology), and others in the future is expected to bring a positive shift in the treatment landscape of HER2+ gastric cancer. LAS VEGAS, June 9, 2025 /PRNewswire/ -- DelveInsight's HER2+ Gastric Cancer (including GEJ) Market report includes a comprehensive understanding of current treatment practices, emerging HER2+ gastric cancer therapies, market share of individual therapies, and current and forecasted HER2+ gastric cancer market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Key Takeaways from the HER2+ Gastric Cancer Market Report As per DelveInsight's analysis, the total market size of HER2+ gastric cancer (including GEJ) in the 7MM is approximately USD 700 million in 2024 and is projected to increase during the forecast period (2025–2034). In 2024, among the current therapies for HER2+ gastric cancer, the largest revenue was generated by Trastuzumab ± Chemotherapy, i.e., USD 140 million in the United States. The total number of incident cases of HER2+ gastric cancer in the 7MM accounted for approximately. 45,000 in 2024. These cases are expected to increase by 2034. Leading HER2+ gastric cancer companies, such as AstraZeneca/Daiichi Sankyo, Merck, Jazz Pharmaceuticals, BeiGene, Zymeworks, Shanghai Henlius Biotech, AbClon, ALX Oncology, Artiva Biotherapeutics, GC Cell, KLUS Pharma, Shanghai Miracogen, Pfizer, Bayer, Enliven Therapeutics, Ambrx, NovoCodex, Mersana Therapeutics, GSK, SystImmune, and others, are developing novel HER2+ Gastric cancer therapies that can be available in the HER2+ gastric cancer market in the coming years. Daiichi Sankyo and AstraZeneca's ENHERTU (trastuzumab deruxtecan), is the only approved therapy for the treatment of advanced or metastatic HER2+ gastric cancer for 2L therapy. The drug received accelerated approval in January 2021. Along with ENHERTU (trastuzumab deruxtecan), KEYTRUDA (pembrolizumab), and HERCEPTIN (trastuzumab) are approved for HER2+ gastric cancer for 1L therapy. Daiichi Sankyo and AstraZeneca's ENHERTU is also expanding into the first-line treatment setting, which is expected to increase its patient share and, consequently, drive growth in the market size. Some of the key HER2+ gastric cancer emerging therapies in the pipeline include ZIIHERA (zanidatamab), Rilvegostomig, HLX22 (AC101), Evorpacept (ALX148), TUKYSA (tucatinib), BAY2927088, AB-201 (GCC2003, HER2 CAR-NK), A166 (Trastuzumab botidotin), MRG002, AIDIXI (disitamab vedotin), BAY2701439, ELVN-002, ARX788, XMT-2056, BL-M07D1, and others. Data presented during the recent ASCO 2025 meeting showed that ENHERTU extended overall survival for more than 3 months in patients with advanced HER2-positive gastric or GEJA following progression on first-line therapy, based on the Phase III DESTINY-Gastric04 trial. In February 2025, AstraZeneca anticipated a data readout from the Phase Ib/II (NCT04379596, DESTINY-Gastric03) trial, which was focused on treating metastatic or unresectable HER2+ gastric cancer, GEJ, and GEA, in 2026. In February 2025, AstraZeneca expected the first patient dosing of ENHERTU (NCT06731478, DESTINY-Gastric05) for HER2+ first-line locally advanced or metastatic gastric cancer or GEJ adenocarcinoma to begin in Q1 2025, with data anticipated to be available after 2026. In the January 2025 presentation, Jazz Pharmaceuticals anticipated the potential approval and launch of zanidatamab as a first-line treatment for GEA in 2026. Additionally, the company is also looking forward to expanding its market strategy for zanidatamab in 2026. In January 2025, ALX Oncology presented positive updated data from the ASPEN-06 Phase II clinical trial at the 2025 ASCO Gastrointestinal Cancers Symposium, demonstrating that the company's investigational CD47-blocker, evorpacept, produces a durable clinical response and exhibits a well-tolerated safety profile in patients with previously treated HER2+ advanced gastric cancer or GEJ cancer. Discover which therapies are expected to grab the HER2+ gastric cancer market share @ HER2+ Gastric Cancer Market Report HER2+ Gastric Cancer Overview Gastric cancer is the fifth most common type of cancer and the fourth leading cause of cancer-related deaths worldwide. HER2, also known as HER2/neu or ERBB2, is found in approximately 15–30% of gastric cancers, including those at the Gastroesophageal Junction (GEJ). It is located on chromosome 17q21 and is part of the EGFR family, which includes EGFR/HER1, HER3, and HER4. The ligand for the HER2 tyrosine kinase receptor remains unidentified. HER2 can form both homodimers and heterodimers with other EGFR family receptors, and overexpression of HER2 can result in ligand-independent activation. In gastric cancer, ERBB2 mutations are most commonly found in the CIN subtype, primarily consisting of missense mutations (74%), with smaller proportions of insertions (22%) and fusions (0.7%). HER2 expression is more frequently observed in the intestinal subtype (according to Lauren's classification), as well as in proximal gastric cancer, GEJ cancer, metastatic disease (particularly liver metastasis), and lymph node involvement. HER2+ Gastric Cancer Epidemiology Segmentation In the 7MM, in 2024, among all the HER2+ Gastric cancer indications, breast cancer accounted for the highest number of incident cases, while ovarian cancer occupied the bottom of the ladder. The HER2+ gastric cancer market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Incident Cases of Gastric Cancer (including GEJ) Gender-Specific Cases of Gastric Cancer (including GEJ) Stage-Specific Cases of Gastric Cancer (including GEJ) Total Incident Cases of HER2+ Gastric Cancer (including GEJ) Total Incident Cases of Advanced HER2+ Gastric Cancer (including GEJ) HER2+ Gastric Cancer Treatment Market HER2, which is overexpressed or amplified in 6–36% of gastric cancer patients, represents a key target in the development of novel treatment strategies for metastatic gastric cancer. While surgical resection remains the primary treatment and can cure patients with early-stage cancer, the survival rates for those with advanced resectable gastric or gastroesophageal junction cancers remain low, despite the introduction of new treatments like perioperative chemotherapy or adjuvant chemoradiation. For patients diagnosed with early-stage disease, gastrectomy is the standard treatment. However, survival rates for those with advanced resectable cancers are still poor, even with the addition of new therapies such as perioperative chemotherapy or adjuvant chemoradiation. Treatment for HER2-positive gastric cancer depends on factors such as tumor size, location, and the patient's overall health. The humanized monoclonal antibody HERCEPTIN (trastuzumab) targets HER2, inhibiting the growth and survival of HER2-dependent tumors. Alongside HERCEPTIN, KEYTRUDA (Merck), one of the first therapies approved for gastric cancer, works by binding to the Programmed Cell Death-1 (PD-1) receptor, blocking its interaction with PD-L1 and PD-L2, and reversing PD-1 pathway-mediated immune suppression, including the antitumor immune response. Most recent approvals for targeted therapies, such as ENHERTU (Daiichi Sankyo) and AIDIXI (Remegen Biosciences), are used in second- and third-line treatments for gastric cancer. Learn more about the FDA-approved HER2+ gastric cancer therapies @ HER2+ Gastric Cancer Treatment Drugs Key Emerging HER2+ Gastric Cancer and Companies Various new therapies are in development with a focus on the mentioned limitations of the currently approved drugs. Some of the most prominent ones include Evorpacept (ALX Oncology), Zanidatamab (Jazz Pharmaceuticals), IAM1363 (Iambic Therapeutics), ELVN-002 (Enliven Therapeutics), ARX788 (Ambrx), Rilvegostomig (AstraZeneca), and others. These emerging drugs play a vital part in fulfilling the unmet need for the treatment approach of HER2+ gastric cancer. Although the space is quite active and various trials are underway to treat patients with HER2+ gastric cancer, continuous efforts are further needed to develop novel drugs that would be more effective and less toxic. ZIIHERA is a bispecific antibody targeting HER2, binding to two extracellular sites on the HER2 protein. In November 2024, the FDA granted accelerated approval for ZIIHERA for adult patients with previously treated, unresectable, or metastatic HER2+ (immunohistochemistry 3+) biliary tract cancer (BTC), identified through an FDA-approved test. Jazz Pharmaceuticals expects to release top-line data in the second quarter of 2025 from the Phase III HERIZON-GEA-01 trial (NCT05152147), which is assessing zanidatamab combined with chemotherapy, with or without tislelizumab, as a first-line treatment for HER2-positive metastatic gastric and esophageal adenocarcinoma (GEA). According to the presentation, Jazz Pharmaceuticals aims to potentially approve and launch zanidatamab as a first-line treatment for gastric cancer in 2026. The company is also planning to expand its market strategy for zanidatamab in 2026. HLX22 (AC101), a novel anti-HER2 monoclonal antibody developed by AbClon and further advanced by Henlius, is currently under investigation. In November 2024, Henlius Biotech announced that the first patient was dosed in the Phase III international multicenter clinical trial (HLX22-GC-301) for HLX22. In October 2024, Henlius received approval from Japan's PMDA for the Clinical Trial Notification (CTN) of a Phase III international multicenter study of HLX22, in combination with trastuzumab and chemotherapy, as a first-line treatment for HER2-positive advanced gastric cancer. The other therapies in the HER2+ gastric cancer pipeline include TUKYSA (tucatinib): Pfizer BAY2927088: Bayer AB-201 (GCC2003, HER2 CAR-NK): Artiva Biotherapeutics and GC Cell A166 (Trastuzumab botidotin): KLUS Pharma MRG002: Shanghai Miracogen AIDIXI (disitamab vedotin): Pfizer BAY2701439: Bayer XMT-2056: Mersana Therapeutics and GSK BL-M07D1: SystImmune and others The anticipated launch of these emerging therapies are poised to transform the HER2+ gastric cancer market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the HER2+ gastric cancer market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. To know more about HER2+ gastric cancer drug clinical trials, visit @ HER2+ Gastric Cancer Drugs HER2+ Gastric Cancer Market Dynamics The HER2+ gastric cancer market dynamics are expected to change in the coming years. HER2-targeted therapies, such as HERCEPTIN, ENHERTU, and anti-PD1 therapy KEYTRUDA, offer more precise treatment by improving efficacy and minimizing side effects compared to traditional chemotherapy. Daiichi Sankyo and AstraZeneca's ENHERTU is expanding into the first-line treatment setting, which is expected to increase its patient share and drive market growth. There is growing research interest in combining next-generation HER2 inhibitors or bispecific antibodies with Immune Checkpoint Inhibitors (ICIs), presenting significant opportunities to enhance treatment efficacy and improve patient survival. Additionally, the HER2+ gastric cancer market is projected to grow due to increased incidence rates, an aging population, and advancements in treatment methodologies, potentially leading to more investment in research and development. Furthermore, potential therapies are being investigated for the treatment of HER2+ gastric cancer, and it is safe to predict that the treatment space will significantly impact the HER2+ gastric cancer market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the HER2+ gastric cancer market in the 7MM. However, several factors may impede the growth of the HER2+ gastric cancer market. HER2+ gastric cancer is an aggressive form of the disease with a significantly high mortality rate, poor survival rates, and a poor prognosis due to factors such as low screening rates, high rates of refractory/relapsed tumors, and the advanced age of patients. The complexity of tumor biology, including intratumoral heterogeneity, poses challenges to effective treatment strategies and limits the efficacy of current therapies. Additionally, HER2+ gastric cancer is prone to developing resistance to targeted therapies, highlighting the need for the continuous development of next-generation agents, which further increases R&D costs. Moreover, HER2+ gastric cancer treatment poses a significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, the HER2+ gastric cancer market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact the HER2+ gastric cancer market growth. HER2+ Gastric Cancer Report Metrics Details Study Period 2020–2034 HER2+ Gastric Cancer Report Coverage 7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] HER2+ Gastric Cancer Market CAGR 13 % HER2+ Gastric Cancer Market Size in 2024 USD 700 Million Key HER2+ Gastric Cancer Companies AstraZeneca/Daiichi SankyoJazz Pharmaceuticals, BeiGene, Zymeworks, Merck, Shanghai Henlius Biotech, AbClon, ALX Oncology, Artiva Biotherapeutics, GC Cell, KLUS Pharma, Shanghai Miracogen, Pfizer, Bayer, Enliven Therapeutics, Ambrx, NovoCodex, Mersana Therapeutics, GSK, SystImmune, and others Key HER2+ Gastric Cancer Therapies ENHERTU, KEYTRUDA, ZIIHERA (zanidatamab), Rilvegostomig, HLX22 (AC101), Evorpacept (ALX148), TUKYSA (tucatinib), BAY2927088, AB-201 (GCC2003, HER2 CAR-NK) A166 (Trastuzumab botidotin), MRG002, AIDIXI (disitamab vedotin), BAY2701439, ELVN-002, ARX788, XMT-2056, BL-M07D1, and others Scope of the HER2+ Gastric Cancer Market Report HER2+ Gastric Cancer Therapeutic Assessment: HER2+ Gastric Cancer current marketed and emerging therapies HER2+ Gastric Cancer Market Dynamics: Conjoint Analysis of Emerging HER2+ Gastric Cancer Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, HER2+ Gastric Cancer Market Access and Reimbursement Discover more about HER2+ gastric cancer drugs in development @ HER2+ Gastric Cancer Clinical Trials Table of Contents 1 Key Insights 2 Report Introduction 3 Executive Summary 4 Epidemiology and Market Methodology 5 HER2+ Gastric Cancer Market Overview at a Glance 5.1 Market Share (%) Distribution of HER2+ Gastric Cancer by Line of Therapies in 2020 in the 7MM 5.2 Market Share (%) Distribution of HER2+ Gastric Cancer by Line of Therapies in 2034 in the 7MM 5.3 Market Share (%) Distribution of HER2+ Gastric Cancer by Therapies in 2020 in the 7MM 5.4 Market Share (%) Distribution of HER2+ Gastric Cancer by Therapies in 2034 in the 7MM 6 Key Events 7 Disease Background and Overview 7.1 Introduction 7.2 Molecular Subtypes of Gastric Cancer 7.3 HER2+ Gastric Cancer 7.4 Causes and Risk Factors Related to Gastric Cancer 7.5 Clinical Manifestations Related to Gastric Cancer 7.6 Diagnosis Related to Gastric Cancer 7.7 Staging of Gastric Cancer 7.8 Current Treatment Practices: Gastric Cancer 7.8.1 Treatment for HER2+ Gastric Cancer 8 Guidelines and Recommendations for HER2+ Gastric Cancer 8.1 PAN-ASIAN ADAPTED (PAGA) ESMO CLINICAL PRACTICE GUIDELINES FOR THE DIAGNOSIS, TREATMENT, AND FOLLOW-UP OF PATIENTS WITH GASTRIC CANCER (2024) 8.2 NATIONAL COMPREHENSIVE CANCER NETWORK (NCCN) GUIDELINES FOR GASTRIC CANCER (2024) 8.3 NICE GUIDELINES FOR OESOPHAGO-GASTRIC CANCER (2023) 8.4 GASTRIC CANCER: ESMO CLINICAL PRACTICE GUIDELINE FOR DIAGNOSIS, TREATMENT AND FOLLOW-UP (2022) 8.5 JAPANESE GASTRIC CANCER TREATMENT GUIDELINES (2021) 9 Epidemiology and Patient Population 9.1 Key Findings 9.2 Assumptions and Rationale: 7MM 9.3 Total Incident Cases of Gastric Cancer (including GEJ) in the 7MM 9.4 United States 9.4.1 Total Incident Cases of Gastric Cancer (including GEJ) in the United States 9.4.2 Gender-specific Cases of Gastric Cancer (including GEJ) in the United States 9.4.3 Stage-specific Cases of Gastric Cancer (including GEJ) in the United States 9.4.4 Total Incident Cases of HER2+ Gastric Cancer (including GEJ) in the United States 9.4.5 Total Incident Cases of Advanced HER2+ Gastric Cancer (including GEJ) in the United States 9.5 EU4 and the UK 9.5.1 Total Incident Cases of Gastric Cancer (including GEJ) in EU4 and the UK 9.5.2 Gender-specific Cases of Gastric Cancer (including GEJ) in EU4 and the UK 9.5.3 Stage-specific Cases of Gastric Cancer (including GEJ) in EU4 and the UK 9.5.4 Total Incident Cases of HER2+ Gastric Cancer (including GEJ) in EU4 and the UK 9.5.5 Total Incident Cases of Advanced HER2+ Gastric Cancer in EU4 and the UK 9.6 Japan 9.6.1 Total Incident Cases of Gastric Cancer (including GEJ) in Japan 9.6.2 Gender-specific Cases of Gastric Cancer (including GEJ) in Japan 9.6.3 Stage-specific Cases of Gastric Cancer (including GEJ) in Japan 9.6.4 Total Incident Cases of HER2+ Gastric Cancer (including GEJ) in Japan 9.6.5 Total Incident Cases of Advanced HER2+ Gastric Cancer (including GEJ) in Japan 10 Patient Journey 11 Marketed Drug 11.1 Key Competitors 11.2 KEYTRUDA (pembrolizumab): Merck 11.2.1 Product Description 11.2.2 Regulatory Milestones 11.2.3 Other Development Activities 11.2.4 Clinical Development 11.2.5 Safety and Efficacy 11.3 ENHERTU (trastuzumab deruxtecan): Daiichi Sankyo and AstraZeneca 11.3.1 Product Description 11.3.2 Regulatory Milestones 11.3.3 Other Development Activities 11.3.4 Clinical Development 11.3.5 Safety and Efficacy 12 Emerging Therapies 12.1 Key Cross Competition 12.2 ZIIHERA (zanidatamab): Jazz Pharmaceuticals, BeiGene, and Zymeworks 12.2.1 Product Description 12.2.2 Other Developmental Activities 12.2.3 Clinical Development 12.2.4 Safety and Efficacy 12.3 Rilvegostomig: AstraZeneca 12.3.1 Product Description 12.3.2 Clinical Development 12.4 HLX22 (AC101): Shanghai Henlius Biotech and AbClon 12.4.1 Product Description 12.4.2 Other Development Activity 12.4.3 Clinical Development 12.4.4 Safety and Efficacy 12.5 Evorpacept (ALX148): ALX Oncology 12.5.1 Product Description 12.5.2 Other Developmental Activities 12.5.3 Clinical Development 12.5.4 Safety and Efficacy 12.6 TUKYSA (tucatinib): Pfizer 12.6.1 Product Description 12.6.2 Other Development Activity 12.6.3 Clinical Development 12.6.4 Safety and Efficacy 13 HER2+ Gastric Cancer (including GEJ): 7MM Analysis 13.1 Key Findings 13.2 Market Outlook 13.3 Conjoint Analysis 13.4 Key Market Forecast Assumptions 13.4.1 Cost Assumptions and Rebates 13.4.2 Pricing Trends 13.4.3 Analogue Assessment 13.4.4 Launch Year and Therapy Uptake 13.5 Total Market Size of HER2+ Gastric Cancer (including GEJ) in the 7MM 13.6 United States Market Size 13.6.1 Total Market Size of HER2+ Gastric Cancer (including GEJ) in the United States 13.6.2 Market Size of HER2+ Gastric Cancer (including GEJ) by Current and Emerging Therapies in the United States 13.7 EU4 and the UK Market Size 13.7.1 Total Market Size of HER2+ Gastric Cancer (including GEJ) in EU4 and the UK 13.7.2 Market Size of HER2+ Gastric Cancer (including GEJ) by Current and Emerging Therapies in EU4 and the UK 13.8 Japan Market Size 13.8.1 Total Market Size of HER2+ Gastric Cancer (including GEJ) in Japan 13.8.2 Market Size of HER2+ Gastric Cancer (including GEJ) by Current and Emerging Therapies in Japan 14 Unmet Needs 15 SWOT Analysis 16 KOL Views 17 Market Access and Reimbursement 17.1 United States 17.1.1 Centre for Medicare and Medicaid Services (CMS) 17.2 EU4 and the UK 17.2.1 Germany 17.2.2 France 17.2.3 Italy 17.2.4 Spain 17.2.5 United Kingdom 17.3 Japan 17.3.1 MHLW 17.4 Market Access and Reimbursement of HER2+ Gastric Cancer (including GEJ) 18 Appendix 18.1 Bibliography 18.2 Report Methodology 19 DelveInsight Capabilities 20 Disclaimer Related Reports HER2+ Gastric Cancer Pipeline HER2+ Gastric Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key HER2+ gastric cancer companies, including Jiangsu HengRui Medicine Co., Ltd., Pieris Pharmaceuticals, BioInvent International, Daiichi Sankyo, AstraZeneca, Shanghai JMT-Bio Inc., Acepodia Biotech, Inc., Klus Pharma Inc., Carisma Therapeutics Inc., Novartis Pharmaceuticals, Celularity Incorporated, Hoffmann-La Roche, DualityBio Inc., Shanghai Miracogen Inc., Bavarian Nordic, among others. HER2+ Gastric Cancer Epidemiology HER2+ Gastric Cancer Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, and the HER2+ gastric cancer epidemiology trends. Gastric Cancer Market Gastric Cancer Market Insight, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key gastric cancer companies, including Hanmi Pharmaceuticals, Merck, Minneamrita Therapeutics, Taiho Pharmaceuticals, Bayer, among others. Gastric Cancer Pipeline Gastric Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key gastric cancer companies, including EMD Serono, Sumitomo Pharma, LintonPharm Co., Ltd., Rapa Therapeutics LLC, Jiangsu HengRui Medicine Co., Ltd., Janssen Pharmaceutical K.K., Genentech, Exelixis, Bristol-Myers Squibb, Pieris Pharmaceuticals, Inc., Pfizer, Leap Therapeutics, CSPC ZhongQi Pharmaceutical, Ellipses Pharma, Amgen, Hanmi Pharmaceutical, Taiho Oncology, Inc., Shanghai Henlius Biotech, LianBio LLC, Chengdu Kanghong Biotech,Eisai Inc., AB Science, Maxinovel Pharmaceuticals, Shanghai Miracogen Inc., GlaxoSmithKline, Hoffmann-La Roche, Merck Sharp & Dohme, Hutchison Medipharma Limited, Genome & Company, Minneamrita Therapeutics LLC, Suzhou Suncadia Biopharmaceuticals Co., Ltd., MacroGenics, ALX Oncology Inc., Codiak BioSciences, Turning Point Therapeutics, Inc., TCRx Therapeutics, InxMed (Shanghai) Co., Ltd., Imugene Limited, SOTIO Biotech, CARsgen Therapeutics Co., Ltd., Zymeworks Inc., NextCure, Inc., Phanes Therapeutics, Pieris Pharmaceuticals, Inc., Athenex, Inc., Curis, Inc., Qurient Co., Ltd., Acepodia Biotech, Inc., Sichuan Baili Pharmaceutical Co., Ltd., Tarus Therapeutics, Inc., Lumicell, Inc., Legend Biotech,Cue Biopharma, TORL Biotherapeutics, LLC, OBI Pharma, Inc, Astellas Pharma, HiberCell, Inc., Celon Pharma SA, Linnaeus Therapeutics, Inc., Inspirna, Inc., Klus Pharma Inc., Genzada Pharmaceuticals, Shanghai PerHum Therapeutics, VM Oncology, LLC, Immunomic Therapeutics, Peptron, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. Contact Us Shruti Thakur info@ +14699457679 Logo: View original content: SOURCE DelveInsight Business Research, LLP
Yahoo
20-05-2025
- Business
- Yahoo
JAZZ Q1 Earnings Call: Revenue and Profit Miss, Product Pipeline Drives Outlook
Biopharma company Jazz Pharmaceuticals (NASDAQ:JAZZ) fell short of the market's revenue expectations in Q1 CY2025, with sales flat year on year at $897.8 million. On the other hand, the company's outlook for the full year was close to analysts' estimates with revenue guided to $4.28 billion at the midpoint. Its non-GAAP profit of $1.68 per share was 63.9% below analysts' consensus estimates. Is now the time to buy JAZZ? Find out in our full research report (it's free). Revenue: $897.8 million vs analyst estimates of $986.6 million (flat year on year, 9% miss) Adjusted EPS: $1.68 vs analyst expectations of $4.66 (63.9% miss) Adjusted EBITDA: $206.5 million vs analyst estimates of $399.6 million (23% margin, 48.3% miss) The company reconfirmed its revenue guidance for the full year of $4.28 billion at the midpoint Management lowered its full-year Adjusted EPS guidance to $4.80 at the midpoint, a 79.4% decrease Operating Margin: -6.2%, down from 7.3% in the same quarter last year Free Cash Flow Margin: 46.3%, up from 28.9% in the same quarter last year Market Capitalization: $6.72 billion Jazz Pharmaceuticals' first quarter results reflected a flat revenue performance and significant shortfall on non-GAAP earnings relative to Wall Street expectations. Management attributed this outcome primarily to strong demand in the neuroscience portfolio, particularly Xywav and Epidiolex, which offset near-term headwinds in oncology products such as Rylaze and Zepzelca. CEO Bruce Cozadd highlighted execution on commercial efforts, stating the company remains 'confident in the blockbuster potential' of Epidiolex and is seeing 'continued momentum' for Xywav, especially in idiopathic hypersomnia. For the remainder of the year, management's guidance is anchored by anticipated regulatory milestones and commercial launches in oncology. The company's strategy includes leveraging recent acquisitions, such as Chimerix, to expand its rare oncology presence and prepare for upcoming product launches like Dordaviprone. Management also addressed ongoing litigation settlements and tariff risks, noting that inventory planning and flexible manufacturing are expected to minimize impacts for 2025. Jazz Pharmaceuticals' Q1 performance was shaped by mixed trends across its portfolio, with neuroscience products showing growth and oncology products experiencing headwinds. Several strategic actions—including a major acquisition and regulatory filings—also influenced the quarter's results and future positioning. Neuroscience Portfolio Growth: Xywav and Epidiolex led revenue growth, with Xywav patient additions driven by targeted disease education campaigns and Epidiolex benefiting from expanded use in adult and long-term care settings. Management emphasized Xywav's status as the only FDA-approved therapy for idiopathic hypersomnia, supporting market expansion. Oncology Pressure and Pipeline: The oncology portfolio saw declines, primarily due to protocol changes affecting Rylaze and competitive dynamics for Zepzelca. Management expects normalization of Rylaze revenue and highlighted upcoming data presentations for Zepzelca's first-line use, which could shift its growth trajectory if included in treatment guidelines. Chimerix Acquisition and Dordaviprone Launch: The acquisition of Chimerix added Dordaviprone, a therapy for rare brain tumors, to the pipeline. Management described Dordaviprone as a "meaningful and durable revenue opportunity" due to its potential frontline use and patent protection into 2037. Supply Chain and Tariff Preparedness: Jazz outlined its extensive manufacturing footprint in the U.S. and Europe, noting that diversified supply and inventory management should mitigate the impact of enacted and potential tariffs for the rest of the year. Strategic R&D Progress: Multiple regulatory milestones are on the horizon, including FDA and European reviews for new oncology indications. Upcoming data from pivotal trials in HER2-positive cancers and the anticipated launch of Dordaviprone are expected to be key product catalysts. Looking ahead, Jazz's guidance relies on continued neuroscience portfolio growth and the successful advancement of its oncology pipeline, while also navigating cost pressures and regulatory developments. Oncology Regulatory Milestones: Management believes that data readouts and regulatory decisions for products like Dordaviprone and zanidatamab will be critical to expanding the oncology business and supporting revenue growth. Neuroscience Market Expansion: The company expects further demand for Xywav, especially in idiopathic hypersomnia, to drive patient growth, while Epidiolex is positioned to achieve blockbuster status through expanded indications and access initiatives. Tariff and Litigation Risks: While management downplayed tariff impacts for 2025 due to inventory and manufacturing flexibility, future regulatory changes or litigation expenses remain uncertainties that could affect margins and adjusted earnings. Jason Gerberry (Bank of America): Asked about Xywav's supply chain resilience if tariffs escalate, with management confirming U.S. manufacturing capacity can supply the domestic market and minimize tariff risk. Jessica Fye (JP Morgan): Inquired about Jazz's overall manufacturing footprint and contingency plans for biopharma tariffs, with management highlighting geographic diversification and a strategy of building U.S. inventory. David Amsellem (Piper Sandler): Questioned the long-term outlook for Zepzelca in the face of new competition, with executives citing upcoming first-line data as potentially expanding its patient base and duration of therapy. Annabel Samimy (Stifel): Sought updates on Rylaze's adoption in adolescent and young adult segments, with management acknowledging slow but steady momentum and confidence in normalization by next quarter. Joseph Thome (TD Cowen): Asked about Dordaviprone's Phase III trial status and regulatory review, with Jazz noting ongoing enrollment outside the U.S. and no current issues with the FDA review timeline. In the coming quarters, the StockStory team will watch for (1) pivotal data releases for zanidatamab in HER2-positive gastroesophageal cancer, (2) the FDA's decision on Dordaviprone and progress in its confirmatory frontline trial, and (3) signs of sustained growth in Xywav and Epidiolex patient populations. Successful integration of Chimerix and the impact of evolving tariff policies will also be important to monitor as the year progresses. Jazz Pharmaceuticals currently trades at a forward P/E ratio of 4.7×. Should you load up, cash out, or stay put? See for yourself in our free research report. Donald Trump's victory in the 2024 U.S. Presidential Election sent major indices to all-time highs, but stocks have retraced as investors debate the health of the economy and the potential impact of tariffs. While this leaves much uncertainty around 2025, a few companies are poised for long-term gains regardless of the political or macroeconomic climate, like our Top 9 Market-Beating Stocks. This is a curated list of our High Quality stocks that have generated a market-beating return of 176% over the last five years. Stocks that made our list in 2020 include now familiar names such as Nvidia (+1,545% between March 2020 and March 2025) as well as under-the-radar businesses like the once-micro-cap company Tecnoglass (+1,754% five-year return). Find your next big winner with StockStory today. 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Yahoo
07-05-2025
- Business
- Yahoo
Jazz Pharmaceuticals (NASDAQ:JAZZ) Misses Q1 Sales Targets
Long-term growth is the most important, but within healthcare, a half-decade historical view may miss new innovations or demand cycles. Jazz Pharmaceuticals's recent performance shows its demand has slowed as its annualized revenue growth of 4.3% over the last two years was below its five-year trend. A company's long-term sales performance is one signal of its overall quality. Even a bad business can shine for one or two quarters, but a top-tier one grows for years. Luckily, Jazz Pharmaceuticals's sales grew at a solid 13.2% compounded annual growth rate over the last five years. Its growth beat the average healthcare company and shows its offerings resonate with customers. Originally founded in 2003 and now headquartered in Ireland following a 2012 tax inversion merger, Jazz Pharmaceuticals (NASDAQGS:JAZZ) develops and markets medicines for sleep disorders, epilepsy, and cancer, with a focus on treatments for patients with limited therapeutic options. "In the first quarter of 2025, our focus on commercial execution resulted in total revenues of $898 million, led by the strong performance of Xywav and Epidiolex. In addition, our team continues to receive positive feedback from healthcare providers on the launch of Ziihera® in its first approved indication of 2L HER2+ BTC. We are affirming our 2025 total revenue guidance range of $4.15 - $4.40 billion, reflecting our confidence in our commercial portfolio delivering top-line growth this year," said Bruce Cozadd, chairman and chief executive officer, Jazz Pharmaceuticals. Operating Margin: -6.2%, down from 7.3% in the same quarter last year The company reconfirmed its revenue guidance for the full year of $4.28 billion at the midpoint Is now the time to buy Jazz Pharmaceuticals? Find out in our full research report . Biopharma company Jazz Pharmaceuticals (NASDAQ:JAZZ) fell short of the market's revenue expectations in Q1 CY2025, with sales flat year on year at $897.8 million. On the other hand, the company's outlook for the full year was close to analysts' estimates with revenue guided to $4.28 billion at the midpoint. Its non-GAAP profit of $1.68 per share was 63.9% below analysts' consensus estimates. Story Continues Jazz Pharmaceuticals Year-On-Year Revenue Growth This quarter, Jazz Pharmaceuticals missed Wall Street's estimates and reported a rather uninspiring 0.5% year-on-year revenue decline, generating $897.8 million of revenue. Looking ahead, sell-side analysts expect revenue to grow 6.4% over the next 12 months, an improvement versus the last two years. This projection is above average for the sector and implies its newer products and services will spur better top-line performance. Software is eating the world and there is virtually no industry left that has been untouched by it. That drives increasing demand for tools helping software developers do their jobs, whether it be monitoring critical cloud infrastructure, integrating audio and video functionality, or ensuring smooth content streaming. Click here to access a free report on our 3 favorite stocks to play this generational megatrend. Operating Margin Operating margin is an important measure of profitability as it shows the portion of revenue left after accounting for all core expenses – everything from the cost of goods sold to advertising and wages. It's also useful for comparing profitability across companies with different levels of debt and tax rates because it excludes interest and taxes. Jazz Pharmaceuticals has done a decent job managing its cost base over the last five years. The company has produced an average operating margin of 11%, higher than the broader healthcare sector. Analyzing the trend in its profitability, Jazz Pharmaceuticals's operating margin decreased by 15.3 percentage points over the last five years, but it rose by 15.3 percentage points on a two-year basis. Still, shareholders will want to see Jazz Pharmaceuticals become more profitable in the future. Jazz Pharmaceuticals Trailing 12-Month Operating Margin (GAAP) This quarter, Jazz Pharmaceuticals generated an operating profit margin of negative 6.2%, down 13.6 percentage points year on year. This contraction shows it was less efficient because its expenses increased relative to its revenue. Earnings Per Share We track the long-term change in earnings per share (EPS) for the same reason as long-term revenue growth. Compared to revenue, however, EPS highlights whether a company's growth is profitable. Jazz Pharmaceuticals's EPS grew at a remarkable 9.2% compounded annual growth rate over the last five years. However, this performance was lower than its 13.2% annualized revenue growth, telling us the company became less profitable on a per-share basis as it expanded. Jazz Pharmaceuticals Trailing 12-Month EPS (Non-GAAP) We can take a deeper look into Jazz Pharmaceuticals's earnings to better understand the drivers of its performance. As we mentioned earlier, Jazz Pharmaceuticals's operating margin declined by 15.3 percentage points over the last five years. Its share count also grew by 9%, meaning the company not only became less efficient with its operating expenses but also diluted its shareholders. Jazz Pharmaceuticals Diluted Shares Outstanding In Q1, Jazz Pharmaceuticals reported EPS at $1.68, down from $2.68 in the same quarter last year. This print missed analysts' estimates, but we care more about long-term EPS growth than short-term movements. Over the next 12 months, Wall Street expects Jazz Pharmaceuticals's full-year EPS of $20.19 to grow 15.8%. Key Takeaways from Jazz Pharmaceuticals's Q1 Results We struggled to find many positives in these results as it lowered its full-year EPS guidance and missed on revenue and EPS. Overall, this quarter could have been better. The stock traded down 3.2% to $107.50 immediately following the results. Jazz Pharmaceuticals didn't show it's best hand this quarter, but does that create an opportunity to buy the stock right now? The latest quarter does matter, but not nearly as much as longer-term fundamentals and valuation, when deciding if the stock is a buy. We cover that in our actionable full research report which you can read here, it's free.
Yahoo
06-05-2025
- Business
- Yahoo
With A 14% Return On Equity, Is Jazz Pharmaceuticals plc (NASDAQ:JAZZ) A Quality Stock?
Many investors are still learning about the various metrics that can be useful when analysing a stock. This article is for those who would like to learn about Return On Equity (ROE). By way of learning-by-doing, we'll look at ROE to gain a better understanding of Jazz Pharmaceuticals plc (NASDAQ:JAZZ). Return on Equity or ROE is a test of how effectively a company is growing its value and managing investors' money. Simply put, it is used to assess the profitability of a company in relation to its equity capital. Trump has pledged to "unleash" American oil and gas and these 15 US stocks have developments that are poised to benefit. How To Calculate Return On Equity? ROE can be calculated by using the formula: Return on Equity = Net Profit (from continuing operations) ÷ Shareholders' Equity So, based on the above formula, the ROE for Jazz Pharmaceuticals is: 14% = US$560m ÷ US$4.1b (Based on the trailing twelve months to December 2024). The 'return' is the income the business earned over the last year. Another way to think of that is that for every $1 worth of equity, the company was able to earn $0.14 in profit. Check out our latest analysis for Jazz Pharmaceuticals Does Jazz Pharmaceuticals Have A Good Return On Equity? Arguably the easiest way to assess company's ROE is to compare it with the average in its industry. Importantly, this is far from a perfect measure, because companies differ significantly within the same industry classification. If you look at the image below, you can see Jazz Pharmaceuticals has a lower ROE than the average (22%) in the Pharmaceuticals industry classification. NasdaqGS:JAZZ Return on Equity April 29th 2025 That's not what we like to see. That being said, a low ROE is not always a bad thing, especially if the company has low leverage as this still leaves room for improvement if the company were to take on more debt. A company with high debt levels and low ROE is a combination we like to avoid given the risk involved. To know the 3 risks we have identified for Jazz Pharmaceuticals visit our risks dashboard for free. How Does Debt Impact ROE? Companies usually need to invest money to grow their profits. That cash can come from issuing shares, retained earnings, or debt. In the first two cases, the ROE will capture this use of capital to grow. In the latter case, the debt used for growth will improve returns, but won't affect the total equity. Thus the use of debt can improve ROE, albeit along with extra risk in the case of stormy weather, metaphorically speaking. Jazz Pharmaceuticals' Debt And Its 14% ROE It's worth noting the high use of debt by Jazz Pharmaceuticals, leading to its debt to equity ratio of 1.49. While its ROE is respectable, it is worth keeping in mind that there is usually a limit as to how much debt a company can use. Investors should think carefully about how a company might perform if it was unable to borrow so easily, because credit markets do change over time.