Impax’s Dual Strategic Focus Unique targeted ANDAs Create valued CNS products First-to-File, First-to-Market Develop strong IP positions Sustainability through IPX066 (RYTARYTM) NDA technically challenging, filed 4Q11 as 505(b)(2) filing difficult to formulate products Partnership for in-licensing IPX159 in Phase IIb as or co-development of 505(b)(1) filing alternative dosage forms Licensed exclusive U.S. 46 apps pending at FDA commercialization rights to 52 under development Zomig®3 Note: Data as of July 31, 2012
Healthy Balance Sheet Supports Ongoing M&A Significant cash and no debt for investments in growth initiatives Strategically Financially Right Attractive Manageable Execution Risk Generic & Brand M&A Candidates4
98 Products Pending or Under Development Future Targeted Opportunities $36 Billion Current U.S. Brand/Generic Sales Present 46 Pending at FDA 41 ($20 Billion) Currently Marketed ANDAs 52 Under Development ($16 Billion) Note: All product sales data included herein are derived from data published by7 Wolters Kluwer Health for the 12 months ended July 2012.
Growing Alternative Dosage Form Partnership Portfolio Currently ADF portfolio of 24 products: – 9 approved – 5 pending at the FDA Brand and Generic sales >$2.5B…a number of them – 10 under development still First-to-File or First-to-Market opportunities • Multiple development, supply and distribution agreements • 9 approved products • 2 topical products pending at FDA • 7 ADF products under development • Supply and commercialization agreement • 1 softgel capsule product pending at FDA • 1 softgel capsule product under development • Development and commercialization agreement • 2 nasal spray products pending at FDA • Development and supply agreement • 2 topical products under development Note: All product sales data included herein are derived from data published by8 Wolters Kluwer Health for the 12 months ended July 2012.
Brand Growth Initiatives Internal R&D Programs Approval and launch of RytaryTM in U.S. Commercialize Zomig® in U.S.10
RYTARY™ (IPX066): ER Carbidopa and Levodopa • Extended release capsule formulation of CD-LD intended to maintain consistent plasma concentration of levodopa for a longer duration verses competitive levodopa products • Indicated for the symptomatic treatment of adult patients with idiopathic Parkinson’s disease • Three phase III studies completed in naive and advanced patients, with primary endpoint measuring reduction of “off time”11
RYTARYTM (IPX066): Next Steps in 2012 Formulation Patent Dec. Feb. Oct. 21, Throughout 2012 Information 2011 2012 2012 Development Milestones Pre-launch 1st patent granted preparation and Aug. 2006 FDA launch planning Expires May 2022 NDA acceptance PDUFA filed of NDA Date Building 2nd patent submission Filing marketing and Dec. 2008 sales team Expires Dec. 2028 Conducting commercial pre- launch activities12
Clinical Stage Pipeline - IPX159 IPX159 – Restless Legs Syndrome (RLS) Product • Ex-US compound (for a different indication), NCE US Overview • Inhibits uptake of neurotransmitters IPX159 Phase IIb study underway Development Overview US registration path 505(b)(1) – 5 year regulatory exclusivity Significant Commercial Opportunity RLS Market 25 million in ~$800 million Opportunity Large Limited U.S. total Good opportunity in pipeline experience prescription commercial fit the U.S. competition RLS symptoms market size Note: Patient information derived from Datamonitor. All product sales data included herein are derived from data published by Wolters Kluwer Health and IMS NDTI June 2010. “Data on file, Impax Laboratories”13
IPX159: Development Status Preclinical & POC Phase I Phase IIa Phase IIb – Initiated December 2011 • Primary endpoint: International Restless Completed Completed Completed Legs Syndrome Study Group (IRLSSG) Rating Scale • Safety and efficacy study • North America, randomized, double- blind, placebo-controlled trial • Approximately 120 subjects • 11 week trial • Results expected first-half 201314
Taiwan Manufacturing Expansion • July 2012 FDA preapproval inspection for RYTARYTM and undisclosed generic drug with no Form 483 observations • Primary manufacturing site for RYTARYTM • Two year expansion project to be completed mid 2013 • Expanded footprint provides space for installation of additional equipment as needed – Capable of supporting annual production of 2B doses15
Strong Platform for Long Term Growth Generic Brand Unique Targeted Offering Long-Term High Value ANDAs Growth Drivers Drug Delivery Expertise Core Competency Product Formulation Development Technology16