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Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) is a global biopharmaceutical company dedicated to improving patients' lives by identifying, developing, and commercializing meaningful products that address unmet medical needs. Headquartered in Dublin, Ireland, with U.S. offices in Palo Alto, CA, and Philadelphia, PA, Jazz Pharmaceuticals employs over 875 people worldwide, fostering a highly collaborative and entrepreneurial culture.
Core Business: Jazz Pharmaceuticals focuses on three main therapeutic areas: sleep, hematology/oncology, and pain. The company's diverse product portfolio includes nine approved therapies across neuroscience and oncology indications. Notable products include Xyrem and Xywav for narcolepsy, Zepzelca for metastatic small cell lung cancer, Rylaze for acute lymphoblastic leukemia, Vyxeos for acute myeloid leukemia, and Epidiolex for severe forms of epilepsy, acquired through the purchase of GW Pharmaceuticals in May 2021.
Recent Achievements: In 2023, Jazz Pharmaceuticals reported strong financial performance, achieving over $3.8 billion in total revenue. The company also completed enrollment for a Phase 3 trial of Zepzelca in first-line small cell lung cancer and advanced several late-stage pipeline projects. In May 2024, the U.S. FDA accepted the Biologics License Application (BLA) for zanidatamab, a HER2-targeted bispecific antibody, with a Priority Review designation for treating biliary tract cancer.
Current Projects: Jazz Pharmaceuticals remains committed to expanding its product portfolio through R&D and strategic acquisitions. Ongoing projects include the development of zanidatamab for multiple HER2-expressing cancers, the Phase 3 trial for the combination of zanidatamab with standard chemotherapy for advanced gastric cancer, and the optimization of Epidiolex for broader epilepsy indications.
Financial Condition: As of December 31, 2023, Jazz Pharmaceuticals reported cash and cash equivalents of $1.6 billion. The company sustained a strong operational cash flow, generating $1.09 billion in 2023. Despite an outstanding long-term debt of $5.8 billion, Jazz's disciplined capital allocation supports continued investment in growth and innovation.
Partnerships: The company has key collaborations with various organizations, including BeiGene, Ltd. for the development of zanidatamab. Additionally, Jazz Pharmaceuticals has a strategic partnership with Life Science Cares to drive social impact through employee volunteerism in the U.S., reinforcing its commitment to community engagement.
Jazz Pharmaceuticals continues to innovate and advance its mission to transform lives through pioneering therapeutics in oncology and neuroscience, positioning itself as a leader in addressing complex and unmet medical needs.
Jazz Pharmaceuticals has initiated the submission of a Biologics License Application (BLA) to the FDA for JZP-458, targeting acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) in patients with hypersensitivity to E. coli-derived asparaginase. The BLA will be reviewed under the FDA's Real-Time Oncology Review program to expedite approval. JZP-458, a recombinant Erwinia asparaginase, received Fast Track designation in October 2019. The company anticipates launching JZP-458 by mid-2021, addressing significant patient needs.
Jazz Pharmaceuticals, in partnership with PharmaMar, announced results from the ATLANTIS Phase 3 study assessing Zepzelca™ (lurbinectedin) combined with doxorubicin for small cell lung cancer (SCLC) patients who progressed after platinum treatment. While the primary endpoint of overall survival was not met, key secondary analyses favored the combination. The study's safety profile was consistent with known data, showing favorable tolerability. The FDA has already granted accelerated approval for Zepzelca. Next steps include providing ATLANTIS data to the FDA for potential full approval.
Jazz Pharmaceuticals (Nasdaq: JAZZ) announced the appointment of Jennifer Cook and Mark D. Smith, M.D. to its Board of Directors, effective December 1, 2020. Cook brings over 30 years of biopharmaceutical experience, while Smith is a recognized expert in health policy. The additions aim to enhance Jazz's strategy for transformative growth, leveraging their expertise to advance product development. Meanwhile, board members Elmar Schnee and Paul Berns will step down before the 2021 annual meeting. Jazz has launched three new products this year, indicating strong commercial activity.
Jazz Pharmaceuticals (Nasdaq: JAZZ) will present at the Jefferies Virtual London Healthcare Conference on November 17, 2020, at 1:10 p.m. EST. Daniel Swisher, President and COO, will provide a company overview and financial update. Interested parties can access the live audio webcast through the Jazz Pharmaceuticals website, where an archive will be available for one week post-event. The company focuses on developing innovative medicines for serious diseases in neuroscience and oncology, serving patients across more than 90 countries.
Jazz Pharmaceuticals announced the presentation of 11 company-sponsored abstracts and several others at the 62nd ASH Annual Meeting from December 5-8, 2020. This record number of accepted abstracts underscores Jazz's commitment to research in hematology and oncology. Highlights include five-year results from the Phase 3 study of Vyxeos in older adults with high-risk acute myeloid leukemia (AML) and data on Defitelio for veno-occlusive disease. The virtual event reflects the company's dedication to addressing urgent therapeutic needs in blood cancers.
Jazz Pharmaceuticals (JAZZ) reported strong third-quarter 2020 results, with total revenues of $600.9 million, a 12% increase from the previous year. The launch of Zepzelca contributed $36.9 million in sales, significantly driving growth in the oncology segment. GAAP net income rose to $148.2 million, or $2.64 per share, while adjusted EPS increased to $4.31. The company raised its 2020 financial guidance, anticipating total revenues of $2.320 - $2.380 billion. Key product launches and R&D progress, including FDA approval of Xywav, highlight a positive trajectory despite COVID-19 challenges.
Jazz Pharmaceuticals announced the publication of a Phase 3 study on Xywav, an oral solution for treating cataplexy and excessive daytime sleepiness in narcolepsy patients. The study demonstrated statistically significant improvements (p<0.0001) in the frequency of cataplexy attacks and Epworth Sleepiness Scale scores compared to placebo. Xywav has FDA approval and features a formulation with 92% less sodium than traditional treatments. Jazz plans to launch Xywav in Q4 2020, enhancing treatment options for narcolepsy patients.
Jazz Pharmaceuticals (Nasdaq: JAZZ) will host a webcast on October 26, 2020, at 4:30 p.m. EDT to discuss the commercial launch of Xywav™, approved by the FDA on July 21, 2020 for narcolepsy treatment. The solution will be available in early November. The presentation will include insights on sodium intake's effects on cardiovascular health and the evaluation of Xywav for idiopathic hypersomnia. The webcast can be accessed through Jazz Pharmaceuticals' website.
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) announced it will report its 2020 third quarter financial results on November 2, 2020, after market close. The company will host a live audio webcast at 4:30 p.m. EST to discuss these results and provide a business update. Interested parties can access the webcast via the Jazz Pharmaceuticals website. A replay will be available for one week.
Headquartered in Dublin, Jazz focuses on developing life-changing medicines in neuroscience and oncology.
Jazz Pharmaceuticals and PharmaMar will present new data for Zepzelca™ (lurbinectedin) at the IASLC 2020 North America Conference on Lung Cancer from October 16-17, 2020. The focus will be on outcomes from the Phase 2 basket trial in small cell lung cancer (SCLC), highlighting patients suitable for platinum re-challenge and those who demonstrated a response. Zepzelca is FDA-approved for metastatic SCLC after platinum-based chemotherapy. Continued approval may depend on further clinical validation.
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