Jazz Pharmaceuticals Reports Q3 2024 Financial Results

Jazz Pharmaceuticals plc reported significant financial results and updated its 2024 guidance. The company achieved record revenues exceeding $1.05 billion in the third quarter of 2024, driven by a 14% year-over-year revenue increase from key growth drivers such as Xywav®, Epidiolex®, and Rylaze®. Bruce Cozadd, the chairman and CEO, highlighted the strong patient demand for Xywav, which saw approximately 400 net patient additions in the third quarter. This robust performance, coupled with continued success from Epidiolex, contributes to Jazz Pharmaceuticals' confidence in maintaining its total revenue guidance of $4.0 to $4.1 billion for 2024.

The company is also gearing up for the expected launch of zanidatamab in the fourth quarter of 2024 for 2L BTC, addressing a significant unmet medical need. In addition, encouraging results from the Phase 3 IMforte trial have been reported, leading to plans for submitting a supplemental New Drug Application (sNDA) for Zepzelca® in the first half of 2025 to support its use in the 1L maintenance setting for ES-SCLC.

Key financial highlights include a 14% combined year-over-year growth of key products, with notable revenue increases for Xywav and Epidiolex. Xywav, a low-sodium treatment option, saw net product sales of $388.5 million, a 17% increase compared to the same period in 2023. The drug now serves approximately 13,625 active patients, including those with narcolepsy and idiopathic hypersomnia.

Epidiolex sales reached $251.6 million in the third quarter of 2024, reflecting an 18% year-over-year increase. It is approved in more than 35 countries outside the U.S., with ongoing studies demonstrating its effectiveness in treating various conditions like Lennox-Gastaut syndrome and tuberous sclerosis complex.

Rylaze experienced a 6% decrease in net product sales, amounting to $98.8 million, due to a temporary impact from updates to pediatric acute lymphoblastic leukemia (ALL) protocols. However, the company expects revenue normalization by early 2025.

Zepzelca also performed well, with net product sales of $85.8 million, a 10% increase year-over-year. The company announced positive Phase 3 trial results for the combination of Zepzelca and Tecentriq® in first-line extensive-stage small cell lung cancer (ES-SCLC), showing significant improvements in overall survival and progression-free survival.

Jazz Pharmaceuticals has a strong pipeline, with several key developments. The U.S. FDA has granted Priority Review for zanidatamab, with a target action date of November 29, 2024. If approved, zanidatamab would be the first HER2-targeted treatment specifically for biliary tract cancer (BTC) in the U.S. Further, top-line progression-free survival data from a Phase 3 trial of zanidatamab in first-line gastroesophageal adenocarcinoma (GEA) is expected by the second quarter of 2025.

The company's financial guidance for 2024 remains robust, affirming total revenue expectations of $4.0 to $4.1 billion. Neuroscience revenue is projected between $2.825 billion and $2.925 billion, while oncology revenue has been adjusted to $1.08 billion to $1.13 billion. Research and development expenses have been revised to $862 million to $908 million on a GAAP basis and $790 million to $830 million on a non-GAAP basis. The company also updated its earnings per share guidance, raising it to a range of $6.70 to $8.50 on a GAAP basis and $19.50 to $20.60 on a non-GAAP basis.

In terms of liquidity, Jazz Pharmaceuticals ended the third quarter of 2024 with $2.6 billion in cash, cash equivalents, and investments, and long-term debt of $6.2 billion. The company also announced a private placement of $1.0 billion aggregate principal amount of 3.125% exchangeable senior notes due 2030 and repurchased approximately $150 million of its ordinary shares.

Overall, Jazz Pharmaceuticals has demonstrated strong financial performance and strategic focus on key growth drivers and pipeline advancements, positioning itself for continued success in 2024 and beyond.