3Impax’s Dual Strategic FocusUnique targeted ANDAsFirst-to-File, First-to-MarketSustainability throughtechnically challenging,difficult to formulate productsPartnership for in-licensingor co-development ofalternative dosage forms45 apps pending at FDA24 under developmentCreate valued CNS productsDevelop strong IP positionsIPX066 (RYTARYTM) NDAfiled 4Q11 as 505(b)(2) filingIPX159 in Phase IIb as505(b)(1) filingLicensed exclusive U.S.commercialization rights toZomig®Note: Data as of November 1, 2012
Healthy Balance Sheet Supports Ongoing M&A4Generic & Brand M&A CandidatesManageableExecutionRiskFinanciallyAttractiveStrategicallyRightSignificant cash and no debt for investments in growth initiatives
…A Leader in Generic MedicinesDr. Carole Ben-MaimonPresident, Global Pharmaceuticals
69 Products Pending or Under Development748CurrentlyMarketedANDAs 24Under Development($5 Billion)45Pending at FDA($20 Billion)PresentFuture Targeted Opportunities$25 Billion Current U.S. Brand/Generic SalesNote: All product sales data included herein are derived from data published byWolters Kluwer Health for the 12 months ended September 2012.
• 2 softgel capsule products pending at FDA8• 2 nasal spray products pending at FDA• 2 topical products under development• 9 approved products (expected launch throughout Oct/Nov 2012)• 2 topical products pending at FDA• 7 topical and other ADF products under developmentAlternative Dosage Form Partnership PortfolioCurrently ADF portfolio of 24 products:– 9 approved– 6 pending at the FDA– 9 under developmentBrand and Generic sales >$2.7B…a numberof them still First-to-File or First-to-MarketopportunitiesNote: All product sales data included herein are derived from data published byWolters Kluwer Health for the 12 months ended September 2012.
92013• Original Opana ER® (FTF – 6 months exclusivity expected)• Doryx®• Concerta®• Numerous undisclosed pending ANDA opportunities2014• Trilipix®• Renvela® tablets (FTF - 6 months exclusivity expected)• Numerous undisclosed pending ANDA opportunities2015• Welchol® tablets (3 months exclusivity expected)• Numerous undisclosed pending ANDA opportunitiesNote: Original Opana ER® ANDA currently approved. Commercialization of pending ANDAswill depend on FDA approval and market dynamics at time of approval.A Snapshot of Generic Launch Opportunities
11Brand Growth InitiativesInternal R&DProgramsApproval and launchof RytaryTM in U.S.MarketZomig® in U.S.
12RYTARY™ (IPX066): ER Carbidopa and Levodopa• Extended release capsule formulation of CD-LD intended tomaintain consistent plasma concentration of levodopa for a longerduration verses competitive levodopa products• Indicated for the symptomatic treatment of adult patients withidiopathic Parkinson’s disease• Three phase III studies completed in naive and advanced patients,with primary endpoint measuring reduction of “off time”
13RYTARYTM (IPX066): Next Steps in 2012/1Q13Dec.2011Feb.2012Throughout 2012/1Q13NDAfiledPre-launchpreparation andlaunch planning Buildingmarketing andsales team Conductingcommercial pre-launch activities Prepare forlaunch in 1Q13FDAacceptanceof NDAFilingPDUFADateJan. 21,2013(a)Development Milestones1st patent granted Aug. 2006 Expires May 20222nd patent submission Dec. 2008 Expires Dec. 2028Formulation PatentInformation(a) The Company announced on Oct. 12, 2012 that the FDA extended the PDUFA date threemonths to review additional requested information. The initial PDUFA date was Oct. 21, 2012.
14Clinical Stage Pipeline - IPX159IPX159 – Restless Legs Syndrome (RLS)IPX159DevelopmentOverviewProductOverview• Ex-US compound (for a different indication), NCE US• Inhibits uptake of neurotransmittersRLS MarketOpportunityUS registration path 505(b)(1) – 5 year regulatory exclusivitySignificant Commercial OpportunityLargeopportunity inthe U.S.ImproveTreatmentOpportunity25 million inU.S.experienceRLSsymptoms~$800 milliontotalprescriptionmarket sizeGoodcommercial fitNote: Patient information derived from Datamonitor. All product sales data included herein are derivedfrom data published by Wolters Kluwer Health and IMS NDTI June 2010.“Data on file, Impax Laboratories”Phase IIb study underway
15IPX159: Development StatusPreclinical & POC Phase I Phase IIa Phase IIb – Initiated December 2011CompletedCompletedCompleted• Primary endpoint: International RestlessLegs 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 quarter 2013
16Taiwan Manufacturing Expansion• July 2012 FDA preapproval inspection for RYTARYTM andundisclosed 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 additionalequipment as needed– Capable of supporting annual production of 2B doses
17Strong Platform for Long Term GrowthUnique TargetedHigh Value ANDAsOffering Long-TermGrowth DriversGeneric BrandDrug DeliveryExpertiseProductDevelopmentFormulationTechnologyCore Competency
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