Latest news with #Supernus
Yahoo
07-05-2025
- Business
- Yahoo
Supernus Pharmaceuticals's (NASDAQ:SUPN) Q1 Sales Beat Estimates But Full-Year Sales Guidance Misses Expectations
Specialty pharmaceutical company Supernus Pharmaceuticals (NASDAQ:SUPN) reported revenue ahead of Wall Street's expectations in Q1 CY2025, with sales up 4.3% year on year to $149.8 million. On the other hand, the company's full-year revenue guidance of $615 million at the midpoint came in 1.6% below analysts' estimates. Its GAAP loss of $0.21 per share was significantly below analysts' consensus estimates. Is now the time to buy Supernus Pharmaceuticals? Find out in our full research report. Supernus Pharmaceuticals (SUPN) Q1 CY2025 Highlights: Revenue: $149.8 million vs analyst estimates of $147.9 million (4.3% year-on-year growth, 1.3% beat) EPS (GAAP): -$0.21 vs analyst estimates of -$0.01 (significant miss) Adjusted EBITDA: -$10.23 million vs analyst estimates of $49.3 million (-6.8% margin, significant miss) The company reconfirmed its revenue guidance for the full year of $615 million at the midpoint Operating Margin: -6.8%, down from -2.2% in the same quarter last year Market Capitalization: $1.81 billion 'Our first quarter results reflect, once again, double-digit revenue growth from our core products, as well as strong growth in adjusted operating earnings,' said Jack Khattar, President and CEO of Supernus. Company Overview With a diverse portfolio of eight FDA-approved medications targeting neurological conditions, Supernus Pharmaceuticals (NASDAQ:SUPN) develops and markets treatments for central nervous system disorders including epilepsy, ADHD, Parkinson's disease, and migraine. Sales Growth Examining a company's long-term performance can provide clues about its quality. Any business can have short-term success, but a top-tier one grows for years. Luckily, Supernus Pharmaceuticals's sales grew at a decent 10.7% compounded annual growth rate over the last five years. Its growth was slightly above the average healthcare company and shows its offerings resonate with customers. Supernus Pharmaceuticals Quarterly Revenue Long-term growth is the most important, but within healthcare, a half-decade historical view may miss new innovations or demand cycles. Supernus Pharmaceuticals's recent performance shows its demand has slowed as its revenue was flat over the last two years. Supernus Pharmaceuticals Year-On-Year Revenue Growth Supernus Pharmaceuticals also breaks out the revenue for its most important segment, . Over the last two years, Supernus Pharmaceuticals's revenue was flat. This segment has outperformed its total sales during the same period, lifting the company's performance. This quarter, Supernus Pharmaceuticals reported modest year-on-year revenue growth of 4.3% but beat Wall Street's estimates by 1.3%.
Washington Post
06-05-2025
- Business
- Washington Post
Supernus: Q1 Earnings Snapshot
ROCKVILLE, Md. — ROCKVILLE, Md. — Supernus Pharmaceuticals Inc. (SUPN) on Tuesday reported a loss of $11.8 million in its first quarter. The Rockville, Maryland-based company said it had a loss of 21 cents per share. Earnings, adjusted for amortization costs and stock option expense, came to 42 cents per share.
Yahoo
06-02-2025
- Health
- Yahoo
Supernus wins FDA approval for Parkinson's pump on fourth try
Supernus Pharmaceuticals has won US approval for its wearable pump Onapgo (apomorphine hydrochloride) to treat symptoms of Parkinson's disease. Supernus' regulatory path for Onapgo has been marked by multiple setbacks over nearly five years, with the Food and Drug Administration (FDA) rejecting three prior applications before securing approval. The company acquired Onapgo, previously known as SPN-830, from US WorldMeds in 2020. Soon after, Supernus submitted its first application for FDA review. However, in 2020, the agency issued a refusal-to-file (RTF) letter, determining that the submission was incomplete and not ready for formal review. Supernus resubmitted the application twice, receiving complete response letters (CRLs) both times. The first 2022 rejection required further analysis of the infusion device and drug product, while the most recent CRL, issued in April 2023, cited product quality concerns and deficiencies in the master file for the proprietary pump. The company resubmitted its fourth application in August, leading to the current approval. Onapgo will now be available for adult Parkinson's disease patients experiencing motor fluctuations. The wearable pump is designed to provide a continuous subcutaneous infusion of Supernus' apomorphine (Apokyn). The drug is intended for patients experiencing 'off' periods, where medication wears off and symptoms return or worsen. The approval is based on a Phase III, 12-week study (NCT02006121) involving 107 patients. Onapgo led to a drop in daily 'off' time and an increase in daily good 'on' time, defined as periods without dyskinesia and the patient's global impression of change (PGIC). Supernus plans to launch Onapgo in the second quarter of 2025, supported by a team of specialists, a nurse education programme, and access support services. The approval adds Onapgo to a growing list of infusion-based Parkinson's treatments. AbbVie's Vyalev (foscarbidopa and foslevodopa), a continuous subcutaneous infusion therapy combining prodrugs of carbidopa and levodopa, was approved in October 2024 after three regulatory attempts. The FDA's initial rejection of Vyalev did not involve efficacy or safety concerns but requested additional information on the pump device. The second rejection followed findings of issues at a third-party manufacturer. AbbVie set a precedent in 2015 with its Parkinson's disease infusion pump therapy Produodopa (foslevodopa foscarbidopa), sparking innovation in drug delivery systems as companies looked for alternatives for conventional oral treatments. "Supernus wins FDA approval for Parkinson's pump on fourth try" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
