Page 1

Jazz Pharmaceuticals Jazz Pharmaceuticals Announces Second Quarter 2021 Financial Results August 3 , 2021 Closed GW Pharmaceuticals plc Acquisition , Creating an Innovative , High - Growth , Global Biopharma Leader 41 % of Net Product Sales from Recently Launched or Acquired Products Strong Xywav ™ Adoption with 5,100 Active Patients Exiting the Second Quarter FDA Approval and Launch of Rylaze ™ in the U.S. Expect to Initiate Pivotal Phase 3 Trial of Epidiolex® for Epilepsy with Myoclonic - Atonic Seizures in First Half 2022 Total Revenues Increased 34 % to $ 751.8 Million Compared to Second Quarter 2020 2021 Total Revenue Guidance Affirmed at $ 3.02 Billion to $ 3.18 Billion DUBLIN , Aug. 3 , 2021 / PRNewswire / -- Jazz Pharmaceuticals plc ( Nasdaq : JAZZ ) today announced financial results for the second quarter of 2021 and affirmed non - GAAP adjusted financial guidance for 2021 . " As we enter what we expect to be a period of sustained growth , I have never been more excited about the future for Jazz . The recent approval and launches of Xywav and Rylaze exemplify Jazz today . We are rapidly establishing ourselves as an innovative biopharmaceutical company with expanding R & D capabilities and substantial commercial prowess , underscored by our consistent execution across the business . The addition of the GW cannabinoid platform and related pipeline complement and enhance our own growing R & D capabilities , accelerating our ability to improve the lives of patients , " said Bruce Cozadd , chairman and chief executive officer of Jazz Pharmaceuticals . " We have now executed four of five planned product launches since the beginning of 2020 and look forward to our anticipated launch of Xywav in idiopathic hypersomnia later this year , a critical step forward for these underserved patients . With 41 % of our second quarter net product sales from recently launched or acquired products , we are well on track to meet our revenue diversification targets while driving significant shareholder value . " Robert lannone , M.D. , M.S.C.E. , executive vice president , research and development and chief medical officer , added , " We are excited that Rylaze was recently approved in the United States and is now broadly available to acute lymphoblastic leukemia and lymphoblastic lymphoma patients in critical need . We aim to further leverage our proven R & D capabilities to deliver on the significant value of our pipeline and the GW cannabinoid platform . The shared values and patient - centricity among the Jazz and GW teams , coupled with the successful ongoing integration , will further enhance our ability to innovate and execute , including the planned initiations of a Phase 3 pivotal trial for Epidiolex in epilepsy with myoclonic - atonic seizures and the third Phase 3 nabiximols clinical trial in multiple sclerosis - related spasticity . " Business Updates Corporate Development On May 5 , 2021 , the Company completed the acquisition of GW Pharmaceuticals plc ( GW ) for a total value of approximately $ 7.2 billion , or $ 6.8 billion net of GW cash . The Company secured $ 5.35 billion of financing to fund the GW transaction . The financing structure supports the Company's plans for rapid deleveraging to its stated targets while also continuing to make investments to grow the business . The combined company is 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 Xywav ) : • Net product sales for the combined oxybate business increased 3 % to $ 458.3 million in the second quarter of 2021 compared to the same period in 2020 . • Average active oxybate patients on therapy were approximately 15,900 in the second quarter of 2021 , an increase of approximately 5 % compared to the same period in 2020 . Xywav ( calcium , magnesium , potassium , and sodium oxybates ) oral solution : • Xywav net product sales were $ 124.2 million in the second quarter of 2021 . • There were approximately 5,100 active patients on Xywav exiting the second quarter of 2021 . • In June 2021 , FDA recognized seven years of Orphan Drug Exclusivity for Xywav . • FDA published its summary of clinical superiority findings for Xywav stating that Xywav is clinically superior to Xyrem by means of greater safety because Xywav provides a greatly reduced chronic sodium burden compared to Xyrem , and that the differences in the sodium content of the two products at the recommended doses will be clinically meaningful in reducing cardiovascular morbidity in a substantial proportion of patients for whom the drug is indicated . • The Company has achieved its goal of obtaining broad payer coverage , having entered into agreements with all three of the largest pharmacy benefit managers . Xyrem ( sodium oxybate ) oral solution : • Xyrem net product sales decreased 25 % to $ 334.2 million in the second quarter of 2021 compared to the same period in 2020 . Xywav in Idiopathic Hypersomnia • FDA has granted Priority Review Designation and accepted the supplemental New Drug Application ( SNDA ) for Xywav in adult patients with idiopathic hypersomnia ( IH ) . The Prescription Drug Fee User Act ( PDUFA ) target date for an FDA decision has been set for August 12 , 2021 , which is in line with the Company's objective of launching in the fourth quarter of 2021 following risk evaluation and mitigation strategy ( REMS ) implementation . Epidiolex / Epidyolex® ( cannabidiol ) : • Epidiolex / Epidyolex net product sales were $ 109.5 million in the second quarter of 2021. This includes sales from May 5 , 2021 , the closing date of the GW Acquisition . • On an unaudited pro forma basis , net product sales in the second quarter of 2021 increased by 32 % to $ 155.9 million compared to the same period in 2020 . • The Company expects to initiate a Phase 3 pivotal trial of Epidiolex for Epilepsy with Myoclonic - Atonic Seizures ( EMAS ) , also known as Doose syndrome , in the first half of 2022 . EMAS represents the fourth target indication for Epidiolex . SunosiⓇ ( solriamfetol ) : • Sunosi net product sales increased by 41 % to $ 12.1 million in the second quarter of 2021 compared to the same period of 2020 . • In the second quarter of 2021 , U.S. prescriptions increased by 25 % compared to the first quarter of 2021 . Nabiximols : • The Company expects to initiate the third Phase 3 nabiximols clinical trial in multiple sclerosis ( MS ) -related spasticity this year . • The two ongoing Phase 3 clinical trials in MS - related spasticity continue to progress . 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 late 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 TM ( lurbinectedin :) • Zepzelca net product sales were $ 55.9 million in the second quarter of 2021 . Sequential demand growth over the first two quarters of 2021 was 8 % and 9 % respectively , offset mainly by reduced inventory holding by distributors . • Robust Zepzelca development program planned :