3. Significant improvements in the past two years
– Quality first culture
– Management and organization structure changes
– Increased the headcount in quality and quality-related areas
– Initiated an internal Quality Improvement Program
• Identify necessary enhancements to Quality systems beyond
Warning Letter and Form 483 observations
– Implemented corrective actions and enhancements across all sites
– Taiwan inspected in July 2012 with no Form 483 observations
3
Committed to Improving Our Operations
Moving in the Right Direction…
Note: Data as of March 4, 2013.
4. Making significant progress in Quality Improvement Program
– Pre-identified some of the recent Form 483 observations
– Working aggressively to complete key aspects of the Quality
Improvement Program
– Ongoing work to identify and address improvement projects
– Work is in addition to responding to the Form 483 observations
Have the financial means to:
– Properly fund resources needed to resolve Form 483 observations
– Improve our operations globally
– Create a top notch manufacturing and quality operation
Promptly resolving the Warning Letter is our highest priority
4
Committed to Improving Our Operations
…But Have More Work to do
5. 5
Generic pipeline targeting $25B U.S. sales
Brand pipeline focused on Central Nervous System (CNS)
Solid platform on which to build long-term growth
Targeting
Sustainable
Generic and
Specialized
Brand Markets
Track record of complex formulation and development
Established drug delivery capabilities
Hatch-Waxman expertise and Paragraph IV successes
Established
Core
Competencies
Diversifying Generic business product mix
Building a Branded business pipeline
Financial resources and flexibility to support growth
Strong and
Flexible
Financial Profile
Note: All brand/generic product sales data included herein are derived from data published by IMS for the 12 months ended January 2013.
Positioned for Future Growth
6. Two Platforms for Growth
6
Unique targeted ANDAs
• Solid Oral Dosage (SOD)
• Alternative Dosage Form (ADF)
First-to-File/First-to-Market emphasis
Focusing on sustainable products
Partnerships/M&A primarily on ADFs
75 products pending at FDA or
under development
Creating highly valued CNS products
RYTARYTM – NDA pending approval
Commercializing Zomig® in the U.S.
Partnerships/M&A areas
• Neurology
• Psychiatry
Building a strong product pipeline
Developing strong IP positions
Note: Data as of February 8, 2013.
Generic Platform Branded Platform
7. Strategy to Create Long Term Growth
7
Revenue Growth
Opportunities
Diversifying Generic
Business product mix
Focusing on building a
strong Brand pipeline
Executing business
development and M&A
activities
Operational
Improvements
Focusing on improving
quality and compliance
Right-sizing manufacturing
costs and capacity
Enhancing management
team across the company
Supported by financial resources and strong balance sheet:
approximately $299MM cash/cash equivalents and no debt
Note: Data as of December 31, 2012
8. Strategic Initiatives for Generic Growth
Organic Growth
through SOD and
ADF Forms
Partnership
Mainly in ADF
M&A
Mainly in ADF
8
Focusing on…
Organic Growth
Both Solid Oral &
Alternative Dosage
Forms (ADF)
Strategic Partnerships
Primarily
in ADFs
Strategic M & A
Primarily
in ADFs
9. 2008 2009 2010 2011 2012
4 4
20
1
1 5
5
9Currently Marketed
Pending at FDA
Under Development
9
34
Growing Alternative Dosage Form Portfolio
ADF Products Offer Potential Market Sustainability
9
Cumulative Growth of Partnership and Internal/Hybrid ADF Projects
Note: Date as of February 8, 2013. All product sales data included herein are derived from data published by IMS for the 12 months ended January 2013.
5
0
25 Future Opportunities are ADFs
A number of them still FTF/FTM opportunities
$4B Current U.S. Brand/Generic Sales
1
10. Pending at FDA Under Development
19
26
5
5
20
Other Solid Oral Controlled-Release Solid Oral Alternative Dosage Form
10
Diversifying Generic Product Pipeline
75 Future Opportunities Pending at FDA or Under Development
$25B Current U.S. Brand/Generic Sales
50
25
25 Total ADF
33% of Pipeline
31 Total C-R SO
42% of Pipeline
19 Total Other SO
25% of Pipeline
Note: Date as of February 8, 2013. All product sales data included herein are derived from data published by IMS for the 12 months ended January 2013.
11. Strategic Initiatives for Brand Growth
Organic Growth
through SOD and
ADF Forms
Partnership
Mainly in ADF
M&A
Mainly in ADF
11
Focusing on…
Organic Growth
Primarily in
Neurology Area
Partnerships
Neurology &
Psychiatry Areas
M & A
Neurology &
Psychiatry Areas
(Products/Companies)
12. Building a Brand Product Pipeline
Migraine
Parkinson’s Disease (carbidopa-levodopa)
Epilepsy
PHASE I OR POC PHASE II PHASE III REGISTRATION APPROVEDPROJECT
Zomig®
RYTARYTM (a)
IPX218
IPX203
IPX231
IPX232
IPX…
Parkinson’s Disease
Parkinson’s Disease
Migraine
12
(a) On Jan. 21, 2013, the Company announced the receipt of a complete response letter from the FDA indicating that the FDA required a
satisfactory re-inspection of the Company’s Hayward manufacturing facility before the RYTARY NDA may be approved. On March 4, 2013, the
Company announced the receipt of a Form 483 following an inspection of Hayward that may hold up approval of RYTARYTM, as analytical method
validation and a portion of the stability data were generated at the Hayward facility.
Exploratory Projects
13. RYTARYTM (IPX066): Preparing for Launch
Carbidopa and Levodopa Extended-Release Capsule
13
DEC.
2011
FEB.
2012
THROUGHOUT
2012 - 2013
NDA
Filed
Pre-launch planning
Building sales &
marketing team
Conducting pre-launch
activities
FDA
Acceptance
of NDA
Filing
PDUFA Date
- Received
Complete
Response
Letter
JAN. 21,
2013(a)
1st Patent Granted
Aug. 2006
Expires May 2022
2nd Patent Granted
Dec. 2008
Expires Dec. 2028
PATENT
INFORMATION
(a) On Jan. 21, 2013, the Company announced the receipt of a complete response letter from the FDA indicating that the FDA required a
satisfactory re-inspection of the Company’s Hayward manufacturing facility before the RYTARYTM NDA may be approved. On March 4,
2013, the Company announced the receipt of a Form 483 following an inspection of Hayward that may hold up approval of RYTARYTM,
as analytical method validation and a portion of the stability data were generated at the Hayward facility.
Source: National Parkinson’s Foundation. Parkinson’s Disease Overview
More than one million people in the U.S., with 50,000-60,000
new cases diagnosed each year in the U.S. alone
RYTARY™ (IPX066) for the Symptomatic Treatment of Parkinson’s Disease
14. Investments Drove Revenue Growth
2004 2005 2006 2007 2008 2009 2010 2011 2012
$91 $112 $135
$274
$210
$358
$683
$513
$573
Created Significant Resources to Fund Business Development and M&A
Financial Flexibility = $299MM in cash/cash equivalents and NO DEBT
Note: $299MM cash and cash equivalents as of December 31, 2012.
Annual revenues as reported (GAAP) except:
2010 which excludes $196MM due to a change in revenue recognition under the Teva Agreement.
2012 which excludes $9MM due to a change in revenue recognition under the OTC Partner Agreement.14
$ millions
26% 8-Year CAGR
15. 15
Generic pipeline targeting $25B U.S. sales
Brand pipeline focused on Central Nervous System (CNS)
Solid platform on which to build long-term growth
Targeting
Sustainable
Generic and
Specialized
Brand Markets
Track record of complex formulation and development
Established drug delivery capabilities
Hatch-Waxman expertise and Paragraph IV successes
Established
Core
Competencies
Diversifying Generic business product mix
Building a Branded business pipeline
Financial resources and flexibility to support growth
Strong and
Flexible
Financial Profile
Note: All brand/generic product sales data included herein are derived from data published by Wolters Kluwer Health for the 12 months ended October 2012.
Positioned for Future Growth