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Jazz Pharmaceuticals Jazz Pharmaceuticals Announces First Quarter 2021 Financial Results May 4 , 2021 Strong Xywav ™ Adoption With 3,900 Active Xywav Patients Exiting The First Quarter Continued ZepzelcaTM Growth Across Second - Line SCLC Setting Xyway in Idiopathic Hypersomnia Granted FDA Priority Review and an August 12 , 2021 , PDUFA Target Action Date On Track to Close Acquisition of GW Pharmaceuticals plc in Early May , Creating an Innovative , High - Growth , Global Biopharma Leader Secured $ 5.35 Billion Financing Including $ 1.5 Billion Senior Secured Notes in Connection with GW Acquisition 23 % of Revenue from Recently Launched Products ; Total Revenues Increased 14 % to $ 607.6 Million Compared to First Quarter 2020 2021 Total Revenue Guidance Affirmed at $ 2.55 Billion to $ 2.70 Billion DUBLIN , May 4 , 2021 / PRNewswire / -- Jazz Pharmaceuticals plc ( Nasdaq : JAZZ ) today announced financial results for the first quarter of 2021 and affirmed financial guidance for 2021 . " Demand for Xywav is strong , as both patients and physicians embrace the health benefits associated with reducing daily sodium intake . We also continue to see robust uptake of Zepzelca among both platinum - resistant and platinum- sensitive small cell lung cancer patients , consistent with the positive feedback we've received on its profile , " said Bruce Cozadd , chairman and chief executive officer of Jazz Pharmaceuticals . " We are on track to deliver significant revenue growth and diversification in 2022 , are poised for two additional product launches this year and look forward to completing the acquisition of GW Pharmaceuticals this month , all key milestones in our transformation to an innovative biopharmaceutical company and neuroscience leader . " Robert lannone , M.D. , M.S.C.E. , executive vice president , research and development and chief medical officer , added , " Across our R & D organization , we've continued our track record of strong execution . We presented positive Xywav data in idiopathic hypersomnia ( IH ) at the American Academy of Neurology Annual Meeting . We are also pleased to have announced that FDA granted priority review of Xyway in IH with a PDUFA goal date set for August 12 , 2021 , bringing us another step closer to delivering this important treatment to patients with IH , for whom there is currently no FDA - approved therapy . Further , our JZP458 program remains on track with a potential approval in mid - 2021 . I'm proud that our continued execution enables us to bring life - changing medicines to often overlooked patient groups with significant unmet need . " Business Updates Corporate Development On February 3 , 2021 , the Company announced that it had entered into a definitive agreement to acquire GW Pharmaceuticals plc ( GW ) for $ 220.00 per American Depositary Share , in the form of $ 200 in cash and $ 20 in Jazz ordinary shares , based on the volume weighted average price of Jazz ordinary shares on Nasdaq for the 15 consecutive trading day period beginning on the 18th trading day immediately preceding the closing date of the transaction , for a total value of approximately $ 7.2 billion , or $ 6.7 billion net of GW cash . The Company has secured $ 5.35 billion of financing to support the GW transaction ; $ 1.5 billion as senior secured notes and a $ 3.85 billion term loan . This financing structure supports the Company's rapid deleveraging to its stated targets . All shareholder and regulatory approvals required for the acquisition have now been obtained . Completion of the acquisition remains subject to the sanction by the High Court of Justice of England and Wales ( Court ) and other customary closing conditions . The Court hearing to sanction the acquisition is currently scheduled for May 5 , 2021 , and the completion of the acquisition is expected to occur shortly thereafter . Upon close of the transaction , the combined company will be a leader in neuroscience with a global commercial and operational footprint , well positioned to maximize the value of its diversified portfolio . Neuroscience Oxybate ( XyremⓇ and XywayTM ) : • Net product sales for the combined oxybate business increased 1 % to $ 411.0 million in the first quarter of 2021 compared to the same period in 2020 . • Average active oxybate patients on therapy were approximately 15,700 in the first quarter of 2021 , an increase of approximately 4 % compared to the same period in 2020 . Strong Xywav uptake , coupled with utilization of our patient access programs , resulted in a 3 % decrease in revenue bottle volume in the first quarter of 2021 compared to the same period in 2020 . Xywav ( calcium , magnesium , potassium , and sodium oxybates ) oral solution : • Xywav net product sales were $ 75.4 million in the first quarter of 2021 . • There were approximately 3,900 active patients on Xywav exiting the first quarter of 2021 , following the U.S. launch in November 2020 . • The Company has achieved its goal of obtaining broad payer coverage , having entered into agreements with all three of the largest pharmacy benefit managers and coverage now at 80 % of commercial lives . The Company continues to work with other payers to further expand coverage . Xyrem ( sodium oxybate ) oral solution : • Xyrem net product sales decreased 18 % to $ 335.6 million in the first quarter of 2021 compared to the same period in 2020 . Xywav in Idiopathic Hypersomnia • The U.S. Food and Drug Administration ( FDA ) has granted Priority Review Designation and confirmed the supplemental New Drug Application ( SNDA ) seeking approval for Xywav in adult patients with idiopathic hypersomnia ( IH ) . The Prescription Drug Fee User Act ( PDUFA ) target action date for an FDA decision has been set for August 12 , 2021 , which is in line with the objective of launching in the fourth quarter of 2021 . • Positive Phase 3 trial results were presented at the American Academy of Neurology annual meeting in April 2021. The efficacy and safety results demonstrate the potential Xywav has for helping people living with IH , an often debilitating neurologic sleep disorder for which there are currently no approved treatments in the U.S. Sunosi® ( solriamfetol ) : • Sunosi net product sales were $ 11.6 million in the first quarter of 2021 , compared to $ 1.9 million in the same period of 2020 following the U.S. launch in July 2019 . • In the first quarter of 2021 , U.S. prescriptions increased 10 % compared to the fourth quarter of 2020 . JZP385 : • JZP385 , a highly selective modulator of T - type calcium channels , is in clinical development for the potential treatment of essential tremor . • The Company expects to initiate a Phase 2b trial in mid - 2021 . JZP150 : • JZP150 , a fatty acid amide hydrolase ( FAAH ) inhibitor , is in clinical development for the potential treatment of post - traumatic stress disorder . • The Company expects to initiate a Phase 2 trial in late 2021 . Oncology Zepzelca ™ ( lurbinectedin :) Zepzelca net product sales were $ 54.3 million in the first quarter of 2021 , with continued growth across both platinum - resistant and platinum - sensitive patients in second - line small cell lung cancer ( SCLC ) . Zepzelca was launched in the U.S. in July 2020 . • The Company anticipates initiating a Phase 3 trial evaluating immunotherapy plus lurbinectedin maintenance therapy , compared to immunotherapy alone , in patients with extensive - stage SCLC after induction chemotherapy in 2021 . • The Company and Pharma Mar , S.A. ( PharmaMar ) continue to engage with FDA regarding the confirmatory data package . JZP458 ( recombinant Erwinia asparaginase ) : • In December 2020 , the Company initiated the submission of a Biologics License Application ( BLA ) to FDA for JZP458 for intramuscular use as a component of a multi - agent chemotherapeutic regimen for the treatment of Acute Lymphoblastic Leukemia ( ALL ) or Lymphoblastic Lymphoma ( LBL ) in adult and pediatric patients who have developed hypersensitivity or silent inactivation to E. coli - derived asparaginase . • The BLA will be reviewed under the Real Time Oncology Review program ( RTOR ) an initiative of FDA's Oncology Center of Excellence designed to expedite the delivery of safe and effective cancer treatments to patients . • The Company is targeting a mid - 2021 launch in the U.S. , subject to FDA approval . • The Company continues to prioritize global development of JZP458 with the objective of ensuring that ALL / LBL patients have access to a reliably - produced , high - quality recombinant asparaginase . Enrollment in the pivotal Phase 2/3 trial continues beyond the current RTOR submission , with the recent initiation of the intravenous cohort .