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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 announces a definitive agreement to divest Sunosi (solriamfetol) to Axsome Therapeutics for an upfront payment of $53 million, along with royalty rights. Sunosi, indicated for excessive daytime sleepiness due to narcolepsy or obstructive sleep apnea, will generate high single-digit royalties on U.S. net sales. This transaction aims to sharpen Jazz's focus on strategic growth in neuroscience and oncology, ensuring uninterrupted patient access to Sunosi during the transition. Completion is expected in Q2 2022, contingent on regulatory approvals.
Jazz Pharmaceuticals has begun construction on a new 60,000 sq. ft. manufacturing facility at Kent Science Park, investing $100 million (£75m) and creating over 100 skilled jobs. The facility, expected to open in 2024, will support the company's regulatory-approved cannabis-based medicines and future developments. This strategic investment underscores Jazz's commitment to the UK market and aims to enhance production capacity. Additionally, the facility will feature eco-friendly designs with solar panels and wildlife promotion measures.
Jazz Pharmaceuticals announced the enrollment of the first patient in a Phase 2 clinical trial, EMERGE-201, assessing the safety and efficacy of Zepzelca (lurbinectedin) for patients with advanced urothelial carcinoma, large cell neuroendocrine carcinoma of the lung, and homologous recombination deficient tumors. The trial will evaluate patient objective response rates as the primary endpoint. With approximately 20 sites in the U.S. participating, the trial aims to address unmet needs in treating these cancers that lack effective therapies beyond traditional chemotherapy.
Jazz Pharmaceuticals (Nasdaq: JAZZ) announced the upcoming presentation of pre-clinical data on JZP815, a next-generation pan-RAF kinase inhibitor, at the AACR 2022 Annual Meeting from April 8-13, 2022. The data indicates that JZP815 effectively inhibits mutant A, B, and CRAF kinases, showcasing anti-tumor activity in cancer models. This investigational drug aims to address unmet needs in solid tumors. Jazz plans to submit an IND for JZP815 within the year, continuing its focus on precision oncology.
Jazz Pharmaceuticals reported 2021 revenues of $3.1 billion, marking a 31% increase from 2020, fueled by strong sales from its neuroscience and oncology segments. The company launched several products, including Xywav, which achieved $535.3 million in sales. R&D advancements led to multiple clinical trials initiation, with a goal of at least five novel product approvals by 2030. For 2022, Jazz estimated revenue between $3.46 to $3.66 billion. However, GAAP net loss for 2021 was $329.7 million, which raises concerns regarding profitability amidst growth.
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) will participate in two upcoming investor conferences. The Cowen 42nd Annual Health Care Conference is scheduled for March 7, 2022, from 2:10 - 2:40 p.m. ET. The Needham Virtual Neuroscience Forum will take place on March 16, 2022, from 1:05 - 1:45 p.m. ET. Webcasts of both presentations will be accessible via the Jazz Pharmaceuticals website for 30 days following the events. Jazz is dedicated to developing innovative therapies for serious diseases.
Jazz Pharmaceuticals (Nasdaq: JAZZ) will release its 2021 fourth quarter and full year financial results on March 1, 2022, post U.S. market close. A live audio webcast will follow at 4:30 p.m. ET to discuss these results and provide important updates. Investors can access the webcast through the company's website. A replay will be available until March 8, 2022. Jazz focuses on developing life-changing medicines in neuroscience and oncology, with a global presence serving patients in nearly 75 countries.
Jazz Pharmaceuticals (JAZZ) has submitted a Supplemental Biologics License Application (sBLA) to the FDA for a Monday/Wednesday/Friday (M/W/F) dosing schedule of Rylaze™ for treating acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in patients with hypersensitivity to E. coli-derived asparaginase. This submission follows Rylaze's initial approval in June 2021 and aims to enhance patient treatment options. The sBLA supports ongoing clinical trial data showing a positive benefit-to-risk profile for Rylaze’s new dosing regimen, which maintains crucial serum asparaginase activity levels.
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) has unveiled its Vision 2025, aiming for $5 billion in revenue by 2025, approval of at least five new products by decade's end, and a 5% improvement in adjusted operating margin. The company anticipates meeting its 2021 revenue guidance of $3.02 to $3.1 billion. In 2021, Jazz successfully launched five key products and integrated GW Pharmaceuticals. The strategy focuses on diversifying revenue, with an expected 65% of 2022 revenue coming from new products. Jazz also targets a net leverage ratio below 3.5x by the end of 2022.
Jazz Pharmaceuticals (JAZZ) reported positive Phase 3 trial results for Xywav, an oral solution approved for treating idiopathic hypersomnia in adults, published in The Lancet Neurology. The trial showed statistically significant improvements in the Epworth Sleepiness Scale (ESS) scores versus placebo. Participants on Xywav maintained low ESS scores (mean 7.0) compared to placebo (mean 13.3). The FDA granted seven years of Orphan Drug Exclusivity for this indication. Xywav is now a key treatment option for approximately 37,000 diagnosed adult patients in the U.S., reflecting significant market potential.
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