SEC Filings

8-K
PERNIX THERAPEUTICS HOLDINGS, INC. filed this Form 8-K on 02/19/2019
Entire Document
 

 

37 Large Market Opportunity Product Opportunity • Potential to switch Silenor ® Rx to OTC for the treatment of occasional sleeplessness • Peak sales potential of approximately $100M • Two pre - IND FDA meetings held (latest in June 2015) provide visibility into development plan • Estimated 4 year development timeline at a cost of ~$13M - $20M • Great profile to support switch program: • Highly favorable safety profile • Addressed unmet need in OTC market for sleep maintenance with minimal next day effects • Non - scheduled / Non - addictive • No association with complex sleep behaviors • Potential for global expansion opportunities • Occasional sleeplessness is a large unmet consumer need • 80% of current sleep aid users are unsatisfied • Limited OTC options that mostly focus on sleep onset (e.g. diphenhydramine) • Current options carry undesirable side effects (morning drowsiness, dependence) • U.S. OTC Sleep Aid Market was estimated $648M in 2014 • Zzzquil TM is the most recent OTC sleep launch in the U.S. and achieved sales of ~$120M in second full year • Significant opportunity to expand the market with a differentiated product • Significant opportunity to potentially develop an OTC version of Silenor ® for occasional sleeplessness given favorable safety and use profile • Current OTC sleep alternatives often focus on sleep onset and possess undesirable side effects (e.g. morning drowsiness); U.S. sales for this category were an estimated $ 648 M in 2014 , and are expected to reach $ 787 M by 2019 • Pernix has had discussions with a number of potential strategic partners Source: Lightspeed GMI/Mintel. 80% % Unsatisfied Users $ 474 $174 US Market: $648M Sleep Aids PM Analgesics Silenor ® Rx to OTC