3. • Submitted responses to recent Form 483 to the FDA on March 21, 2013
• Requested a meeting with San Francisco District Office to ensure plans
and actions are in alignment with the FDA’s expectations
Significant improvements in the past two years
– Quality first culture
– Management and organization structure changes
– 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
3
Committed to Improving Our Operations
Moving in the Right Direction
Note: Data as of May 1, 2013.
4. 4
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 February 2013.
Positioned for Future Growth
5. Two Platforms for Growth
5
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
74 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 product pipeline
Developing strong IP positions
Note: Data as of May 1, 2013.
Generic Platform Branded Platform
6. Strategy to Create Long Term Growth
6
Revenue Growth
Opportunities
Diversifying Generic
Business product mix
Focusing on building a
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 $400MM cash/cash equivalents and no debt
Note: Approximately $400MM in cash and cash equivalents. As of March 31, 2013, cash and cash equivalents were $349MM, and excluded a $102MM
pre-tax (approximately $65MM after-tax) receipt from Endo Health Solutions received in April 2013.
7. Strategic Initiatives for Generic Growth
Organic Growth
through SOD and
ADF Forms
Partnership
Mainly in ADF
M&A
Mainly in ADF
7
Focusing on…
Organic Growth
Both Solid Oral &
Alternative Dosage
Forms (ADF)
Strategic Partnerships
Primarily
in ADFs
Strategic M & A
Primarily
in ADFs
8. 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
8
Cumulative Growth of Partnership and Internal/Hybrid ADF Projects
Note: Date as of May 1, 2013. All product sales data included herein are derived from data published by IMS for the 12 months ended February 2013.
5
0
25 Future Opportunities are ADFs
A number of them still FTF/FTM opportunities
$4B Current U.S. Brand/Generic Sales
1
9. Pending at FDA Under Development
17
27
5
5
20
Other Solid Oral Controlled-Release Solid Oral Alternative Dosage Form
9
Diversifying Generic Product Pipeline
74 Future Opportunities Pending at FDA or Under Development
$25B Current U.S. Brand/Generic Sales
49
25
25 Total ADF
34% of Pipeline
32 Total C-R SO
43% of Pipeline
17 Total Other SO
23% of Pipeline
Note: Date as of May 1, 2013. All product sales data included herein are derived from data published by IMS for the 12 months ended February 2013.
10. Strategic Initiatives for Brand Growth
Organic Growth
through SOD and
ADF Forms
Partnership
Mainly in ADF
M&A
Mainly in ADF
10
Focusing on…
Organic Growth
Primarily in
Neurology Area
Partnerships
Neurology &
Psychiatry Areas
M & A
Neurology &
Psychiatry Areas
(Products/Companies)
11. 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
11
(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
12. Investments Drove Revenue Growth
2006 2007 2008 2009 2010 2011 2012
$135
$274
$210
$358
$683
$513
$573
Created Significant Resources to Fund Business Development and M&A
Financial Flexibility = Approximately $400MM in cash/cash equivalents and NO DEBT
Note: Approximately $400MM cash and cash equivalents . As of March 31, 2013, cash and cash equivalents were $349MM, and
excluded a $102MM pre-tax (approximately $65MM after-tax) receipt from Endo Health Solutions received in April 2013.
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.
12
$ millions
27% 6-Year CAGR
13. 13
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 February 2013.
Positioned for Future Growth