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HB HARMONY BIOSCIENCES Harmony Biosciences Reports Third Quarter 2021 Financial Results and Business Updates November 9 , 2021 WAKIX® ( pitolisant ) Net Revenue of $ 80.7 Million for Third Quarter 2021 Increase of 77 % vs. the Same Period in 2020 Average Number of Patients on WAKIX Increased to ~ 3,500 Announced Inclusion of WAKIX in American Academy of Sleep Medicine's ( AASM ) Updated Clinical Practice Guideline Conference Call and Webcast to be Held Today at 8:30 a.m. ET PLYMOUTH MEETING , Pa . , Nov. 09 , 2021 ( GLOBE NEWSWIRE ) -- Harmony Biosciences Holdings , Inc. ( " Harmony " or the " Company " ) ( Nasdaq : HRMY ) , a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases , today reported financial results and business updates for the quarter ended September 30 , 2021 . " The company continues to execute on optimizing the performance of WAKIX , demonstrated by another solid quarter of sequential revenue growth with an average number of patients on WAKIX of approximately 3,500 , " stated John C. Jacobs , President and Chief Executive Officer of Harmony . " Inclusion of WAKIX in the recently updated AASM clinical practice guideline is further evidence of its favorable benefit - risk profile . We believe this updated clinical practice guideline has resulted in increased awareness of WAKIX by healthcare professionals who are seeking meaningfully differentiated treatment options for people living with narcolepsy . Our vision remains focused on building Harmony into a leading neurological disease company serving patients suffering from rare diseases , for which there is high unmet medical need . In addition to optimizing WAKIX's performance , our three - pillar growth strategy also includes broadening the clinical utility of WAKIX in additional indications , as well as acquiring new assets . " Third Quarter 2021 Financial Results Net product revenues for the quarter ended September 30 , 2021 were $ 80.7 million , compared to $ 45.6 million for the same period in 2020. The 77.0 % growth versus the same period in 2020 can be primarily attributed to strong commercial sales of WAKIX driven by organic demand . For the quarter ended September 30 , 2021 , GAAP net loss available to shareholders was $ 9.6 million , or a loss of $ 0.17 per diluted share driven by a one - time charge of $ 26.1 million related to the extinguishment of our prior less advantageous debt facility . This compares to a net loss available to shareholders of $ 4.1 million , or a loss of $ 0.14 per diluted share , for the same period in 2020. Non - GAAP adjusted net income was $ 30.4 million , or $ 0.51 per diluted share , for the quarter ended September 30 , 2021 , compared to a non - GAAP adjusted net income of $ 7.7 million , or $ 0.25 per diluted share , for the same period in 2020 . Reconciliations of applicable GAAP measures to non - GAAP adjusted information are included at the end of the press release . The components of Harmony's operating expenses include : • Research and Development expenses were $ 11.7 million in the third quarter of 2021 as compared with $ 4.2 million for the same quarter in 2020 ; • Sales and Marketing expenses were $ 16.5 million in the third quarter of 2021 as compared to $ 12.6 million for the same quarter in 2020 , representing a 30.8 % increase ; • General and Administrative expenses were $ 16.9 million in the third quarter of 2021 as compared to $ 10.5 million for the same quarter in 2020 , representing a 60.4 % increase ; and • Total Operating Expenses were $ 45.1 million in the third quarter of 2021 as compared with $ 27.3 million for the same quarter in 2020 , representing a 64.9 % increase . As of September 30 , 2021 , Harmony had cash and cash equivalents of $ 189.7 million . In August 2021 , Harmony entered into a strategic financing collaboration with Blackstone to provide up to $ 330 million in financing which includes $ 200 million to refinance the Company's existing debt at a lower interest rate , $ 100 million for drawdown within the next twelve months , and a $ 30 million equity investment in Harmony common stock . Clinical Development and Recent Updates • The American Academy of Sleep Medicine published an updated clinical practice guideline which includes WAKIX as a recommended treatment option for adults living with narcolepsy . The new clinical practice guideline was published in the Journal of Clinical Sleep Medicine in a special article titled , " Treatment of central disorders of hypersomnolence : an American Academy of Sleep Medicine clinical practice guideline . " The new guideline updates and replaces the previous AASM guideline published in 2007 , and now includes WAKIX as a strong recommendation for the treatment of narcolepsy in adults based on data that showed clinically significant improvement in excessive daytime sleepiness ( EDS ) and cataplexy in patients treated with WAKIX . • Enrollment continues in Harmony's Phase 2 proof of concept clinical trial evaluating the safety and efficacy of pitolisant for the treatment of EDS and other symptoms in patients with PWS with top line data anticipated in the first half of 2022 . • Our Phase 2 proof of concept clinical trial to evaluate the safety and efficacy of pitolisant for EDS and other non - muscular