3. 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
4. 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 Candidates
4
7. 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 by
7 Wolters Kluwer Health for the 12 months ended July 2012.
8. 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 by
8
Wolters Kluwer Health for the 12 months ended July 2012.
10. Brand Growth Initiatives
Internal R&D
Programs
Approval and launch
of RytaryTM in U.S.
Commercialize
Zomig® in U.S.
10
11. 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
12. 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 activities
12
13. 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
14. 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 2013
14
15. 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 doses
15
16. 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 Technology
16