Press release

KemPharm Reports Second Quarter 2021 Financial Results

Corporate and Regulatory Highlights U.S. Commercial Launch of AZSTARYS™ Initiated on July 21, 2021Serdexmethylphenidate (SDX) Classified as a Schedule IV

articleZevra Therapeutics, Inc.August 12, 20213/company/zevra-therapeutics-inc/news/kempharm-reports-second-quarter-2021-financial-results-2021-08-12
KemPharm Reports Second Quarter 2021 Financial Results

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[{"type":"text","content":"Corporate and Regulatory Highlights U.S. Commercial Launch of AZSTARYS™ Initiated on July 21, 2021Serdexmethylphenidate (SDX) Classified as a Schedule IV Controlled Substance by the DEAAnnounced Orange Book Listing for Six Patents Covering SDX and Confirmation of NCE StatusKemPharm Added to Russell 2000® and Russell 3000® Indexes Financial Highlights Q2 2021 net income of $0.18 per basic shareReported Q2 2021 revenue of $12.0 millionConfirmed receipt of $10 million milestone payment for DEA scheduling of SDXTotal cash and cash equivalents was $132.3 million at June 30, 2021 CELEBRATION, Fla., Aug. 12, 2021 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ: KMPH), a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, today reported its financial results for the second quarter ended June 30, 2021. “The second quarter of 2021 and recent weeks continued what has been a period of unprecedented growth and opportunity for KemPharm, highlighted by the U.S. commercial launch of AZSTARYS,” said Travis C. Mickle, Ph.D., President and Chief Executive Officer of KemPharm. “AZSTARYS, previously KP415, was conceived based on the vision that our LAT® technology was well-suited to developing a prodrug of d-methylphenidate (d-MPH) that could address key patient and prescriber demands that were underserved by ADHD products on the market at the time. Today that vision is a reality, and as the commercial rollout of AZSTARYS by Corium continues, ADHD patients and their caregivers will have the opportunity to benefit from the unique attributes inherent only to AZSTARYS. It is a truly exciting time for KemPharm and, we believe, for the millions of patients seeking a better treatment option for their ADHD symptoms.” Dr. Mickle continued, “In addition to the commercial launch of AZSTARYS, the second quarter was highlighted by the classification of serdexmethylphenidate (SDX) as a Schedule IV controlled substance by the Drug Enforcement Administration (DEA). SDX comprises 70% of the active pharmaceutical ingredient (API) in AZSTARYS, which is classified as a Schedule II controlled substance. Importantly, the classification of SDX as a Schedule IV controlled substance and the unique properties of SDX, we believe, provide us the opportunity to develop an SDX-based product candidate or candidates that could potentially...

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