APOKYN

Supernus Announces Third Quarter 2023 Financial Results

Retrieved on: 
Wednesday, November 8, 2023
Adjustment, Topiramate, FDA, MADRS, New Drug Application, IND, PD, PDUFA, MDD, DSM-IV codes, Investigational New Drug, Research and development, GAAP, CNS, R, Phase, Prescription, Parkinson's disease, Depreciation, APOKYN, NDA, Safety, Psych, Patient, IQVIA, ADHD, Central nervous system, Attention deficit hyperactivity disorder predominantly inattentive, Video game, Medical device, Pharmaceutical industry, Cryptocurrency, Viloxazine

Total revenues (GAAP) of $153.9 million in the third quarter of 2023; total revenues excluding Trokendi XR® net product sales (non-GAAP)(2), increased by 24% in the third quarter of 2023, compared to the same period in 2022

Key Points: 
  • Total revenues (GAAP) of $153.9 million in the third quarter of 2023; total revenues excluding Trokendi XR® net product sales (non-GAAP)(2), increased by 24% in the third quarter of 2023, compared to the same period in 2022
    Qelbree® net product sales of $37.1 million in the third quarter of 2023, a 103% increase compared to the third quarter of 2022 and a 20% increase compared to the second quarter of 2023
    GOCOVRI® net product sales of $32.9 million in the third quarter of 2023, an 18% increase compared to the third quarter of 2022 and a 14% increase compared to the second quarter of 2023
    Operating earnings (GAAP) of $8.1 million in the third quarter of 2023, compared to an operating loss (GAAP) of ($1.5) million in the third quarter of 2022
    Adjusted operating earnings (non-GAAP) of $37.3 million in the third quarter of 2023, an increase of 47% compared to the third quarter of 2022
    SPN-830 (apomorphine infusion device) NDA resubmission accepted for review by FDA; PDUFA date of April 5, 2024
    ROCKVILLE, Md., Nov. 08, 2023 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced financial results for the third quarter of 2023, and associated Company developments.
  • “Our third-quarter performance underscores the strength of our growth products, with combined Qelbree and GOCOVRI net product sales increasing 52% in the third quarter of 2023 compared to the same period last year,” said Jack Khattar, President and CEO of Supernus.
  • Qelbree continues to expand its base of prescribers, with approximately 24,189 prescribers in the third quarter of 2023, up from 21,291 prescribers in the second quarter of 2023.
  • A reconciliation of the full year 2023 financial guidance for Operating Loss (GAAP) to Adjusted Operating Earnings (non-GAAP) is included under the heading “Full Year 2023 Financial Guidance – GAAP to Non-GAAP Adjustments.”
    The Company hosted a successful Research & Development (R&D) Day in October 2023 highlighting clinical and R&D progress and its emerging pipeline of novel CNS product candidates.

TruPharma, LLC Announces Approval and Launch of Apomorphine Hydrochloride Cartridges, 30 mg/3 mL (10 mg/mL), the First Generic Version of APOKYN® Cartridges

Retrieved on: 
Tuesday, March 1, 2022
CGT, RLD, MDD, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, API, Abbreviated New Drug Application, PD, LLC, ANDA, Injection, Food, FDA, Marketing, APOKYN, Generic drug, Sage

Sage is the "first approved applicant" for Apomorphine Hydrochloride Injection, 30 mg/3 mL (10 mg/mL), Single-Patient-Use glass cartridge for use with a reusable pen injector (APOKYN[ Pen).

Key Points: 
  • Sage is the "first approved applicant" for Apomorphine Hydrochloride Injection, 30 mg/3 mL (10 mg/mL), Single-Patient-Use glass cartridge for use with a reusable pen injector (APOKYN[ Pen).
  • FDA therefore determined that Sage is eligible for 180 days of Competitive Generic Therapy (CGT) exclusivity.
  • TruPharma will continue supplying apomorphine hydrochloride cartridges to the trade, but in limited quantities due to current manufacturing and supply chain constraints.
  • [1] APOKYN is a registered trademark of BRITUSWIP.US WorldMeds, LLC is the licensee and distributor of APOKYN.