Jazz Pharma Reports Q1 Epidiolex Sales Increased 6% To $157.9M YoY

Jazz Pharmaceuticals plc JAZZ released financial results for the first quarter of 2022.

Financial Highlights Q1 2022

• GAAP net income was $1.6 million, or $0.03 per diluted share, a drop of 98.68% compared to $121.8 million, or $2.09 per diluted share, in the same period in 2021.

• Total revenues of $813.7 million; 34% increase compared to the same period in 2021

• Neuroscience net product sales increased 45% to $612.1 million compared to the same period in 2021 primarily driven by Epidiolex/Epidyolex net product sales in the first quarter of 2022 of $157.9 million following the acquisition of GW Pharmaceuticals In 1Q22, oxybate net product sales increased 6% to $433.6 million.

• Oncology net product sales increased 10% to $196.8 million compared to the same period in 2021 primarily driven by Rylaze net product sales in 1Q22 of $54.2 million following product launch in July 2021, partially offset by Erwinaze/Erwinase net product sales in 1Q21 of $41.1 million.

Other Highlights

• Epidiolex/Epidyolex net product sales increased 6% to $157.9 million in 1Q22 compared to the same period in 2021, on a proforma basis.

• Epidiolex/Epidyolex net product sales in 4Q21 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.

• Epidiolex is now commercially available and fully reimbursed in four of the five key European markets: United Kingdom, Germany, Italy and Spain, with an anticipated launch in France in 2022. The company has made significant progress on its European roll out with launches in Spain, Italy and Switzerland in 3Q21 and Ireland and Norway in 1Q22.

• The company expects to initiate a Phase 3 pivotal trial of Epidiolex for Epilepsy with Myoclonic-Atonic Seizures, 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 CBD preparation used in Epidiolex and the treatment of indicated disorders using that CBD preparation.

• Submitted a Rylaze Supplemental Biologics License Application for Monday/Wednesday/Friday intramuscular dosing and an sBLA for intravenous administration; both are being reviewed under the Real-Time Oncology Review program

• First patient enrolled in Zepzelca EMERGE-201 Phase 2 basket trial

"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," stated Bruce Cozadd, chairman and CEO of Jazz Pharmaceuticals.

"Our recent launches of Xywav, in both narcolepsy and idiopathic hypersomnia, and Rylaze in acute lymphoblastic leukemia, 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."

As of March 31, 2022, cash and cash equivalents were $490.8 million, and the outstanding principal balance of the company's long-term debt was $6.2 billion compared to $6.4 billion as of December 31, 2021. In addition, the company had undrawn borrowing capacity under a revolving credit facility of $500.0 million. For the three months ended March 31, 2022, the company generated $209.0 million of cash from operations. In 1Q22 the company repaid in full the $251.0 million remaining aggregate principal amount of the Euro term loan B.

Photo: Courtesy of PRNewsFoto/Jazz Pharmaceuticals plc