Jazz Pharmaceuticals Reports Q1 2024 Results and Confirms 2024 Guidance

Jazz Pharmaceuticals plc, a global biopharmaceutical company, recently reported significant financial and operational progress for the first quarter of 2024. The company highlighted a 12% year-over-year increase in revenue driven by key products: Xywav®, Epidiolex®, and Rylaze®. Furthermore, oncology revenues grew by 13% from the previous year, underscoring the company's growth trajectory.

CEO Bruce Cozadd noted the remarkable advancements, particularly in the zanidatamab program, with the submission of a Biologics License Application (BLA) for second-line biliary tract cancer (2L BTC). This submission is an essential step toward potential accelerated approval, with expectations to launch zanidatamab in 2025 or sooner. Additionally, Jazz Pharmaceuticals anticipates top-line Phase 2b data from the suvecaltamide trial for essential tremor by late in the first half of 2024.

Jazz Pharmaceuticals affirmed its 2024 total revenue guidance at $4.0 to $4.2 billion. The company’s financial highlights for the first quarter of 2024 included a 14% increase in net product sales for Xywav to $315.3 million, driven by its unique positioning as a low-sodium oxybate. Xywav is the only approved therapy for idiopathic hypersomnia (IH), showing significant uptake with approximately 12,950 active patients by the end of the first quarter.

Epidiolex/Epidyolex, another key growth driver, saw a 5% increase in net product sales to $198.7 million. The product's growth was slightly affected by inventory adjustments. However, Epidiolex has been approved in over 35 countries, with more launches and reimbursements expected throughout 2024. Long-term data presented at the 2024 Annual Meeting of the American Academy of Neurology (AAN) showcased Epidiolex's sustained efficacy in reducing treatment-resistant seizures over 144 weeks.

Rylaze/Enrylaze's net product sales surged 20% to $102.8 million, solidifying its role as a critical component in the company's portfolio. Jazz Pharmaceuticals also reported a 13% increase in oncology revenues, driven by products like Zepzelca®, which saw a 12% rise in net product sales. The company completed enrollment for a Phase 3 trial evaluating Zepzelca in combination with Tecentriq for first-line small cell lung cancer (SCLC), with top-line results expected by late 2024 or early 2025.

Significant pipeline milestones include plans to initiate the Phase 3 EMPOWHER trial for zanidatamab in late-line HER2-positive breast cancer in the second half of 2024. Additionally, the company is set to release top-line data from multiple late-stage trials, including Epidyolex's Phase 3 trial in Japan and Zepzelca's Phase 3 trial in SCLC.

Financially, Jazz Pharmaceuticals reported a slight increase in total revenues for the first quarter of 2024, up 1% from the previous year. This growth was primarily driven by a strong performance in oncology, offset by a decline in neuroscience revenues due to decreased Xyrem® sales and increased competition. The company posted a GAAP net loss of $14.6 million for the first quarter, while non-GAAP adjusted net income stood at $182.2 million.

Operating expenses saw an increase, attributed to higher compensation-related expenses, investment in priority programs, and litigation costs. Research and development expenses also rose, driven by ongoing pipeline programs, including zanidatamab.

As of March 31, 2024, Jazz Pharmaceuticals had $1.8 billion in cash, cash equivalents, and investments, with a long-term debt balance of $5.8 billion. The company generated $267.2 million in cash from operations during the first quarter, reflecting robust business performance and financial discipline. Jazz Pharmaceuticals remains committed to its growth strategy, supported by a strong portfolio of approved products and a promising pipeline of innovative therapeutics.