Jazz Reports Hiccup In Epidiolex Inventories

Jazz Pharmaceuticals plc (Nasdaq: JAZZ) announced financial results for the first quarter of 2022, raised 2022 financial guidance, and provided business updates.

“We’re pleased to raise our top- and bottom-line guidance, driven by our continued execution and significant progress across commercial and R&D in the first quarter, which positions us well for the rest of the year and to achieve Vision 2025,” said Bruce Cozadd, chairman and CEO of Jazz Pharmaceuticals. “Our recent launches of Xywav, in both narcolepsy and idiopathic hypersomnia (IH), and Rylaze in acute lymphoblastic leukemia (ALL), continue to generate increased prescriber and patient adoption, and demonstrate our ability to deliver innovative new medicines to improve the lives of patients and their families. On the corporate development front, our three recent transactions are aligned with our broader strategy, allowing us to focus on our highest priorities, enhance our pipeline in areas of key interest in neuroscience and oncology and drive long-term shareholder value.”

GAAP net income in 1Q22 was $1.6 million, or $0.03 per diluted share, compared to $121.8 million, or $2.09 per diluted share, for 1Q22. Non-GAAP adjusted net income in 1Q22 was $261.9 million, or $3.73 per diluted share, compared to $228.8 million, or $3.92 per diluted share, for 1Q22.

Epidiolex Results

Jazz reported that its Epidiolex/Epidyolex net product sales increased 6% to $157.9 million in the first quarter of 2022 compared to the same period in 2021, on a proforma basis. Epidiolex/Epidyolex net product sales in the fourth quarter were favorably impacted by approximately $18 million, due to a temporary increase in specialty pharmacy inventory levels at the end of 2021. The majority of this increase reversed in 1Q22, reducing 1Q22 revenues.

“Excluding this impact, we saw double-digit percentage revenue growth in 1Q22 compared to 1Q21, and sequential growth in underlying demand, despite challenges posed by the Omicron variant.”

Jazz said that Epidyolex is now commercially available and fully reimbursed in four of the five key European markets: United Kingdom, GermanyItaly and Spain, with an anticipated launch in France in 2022. The company said it has made significant progress on its European rollout with launches in SpainItaly and Switzerland in 3Q21 and Ireland and Norway in 1Q22.

Jazz said it expects to initiate a Phase 3 pivotal trial of Epidiolex for Epilepsy with Myoclonic-Atonic Seizures (EMAS), the fourth target indication for Epidiolex, in 1H22. The company continues to strengthen the durability of Epidiolex. Patent US 11,207,292 is Orange Book listed and extends through 2039. This patent covers the composition of the botanically derived cannabidiol (CBD) preparation used in Epidiolex and the treatment of indicated disorders using that CBD preparation.

 

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