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Cowen & Co
Health Care Conference
March 6, 2013
Safe Harbor Statement
“Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995:
To the extent any statements made in this presentation contain information that is not historical, these statements are forward-
looking in nature and express the beliefs and expectations of management. Such statements are based on current
expectations and involve a number of known and unknown risks and uncertainties that could cause the Company’s future
results, performance or achievements to differ significantly from the results, performance or achievements expressed or
implied by such forward-looking statements. Such risks and uncertainties include, but are not limited to, the effect of current
economic conditions on the Company’s industry, business, financial position and results of operations, fluctuations in
revenues and operating income, the Company’s ability to promptly correct the issues raised in the warning letter and Form
483 observations received from the FDA, the Company’s ability to successfully develop and commercialize pharmaceutical
products in a timely manner, reductions or loss of business with any significant customer, the impact of consolidation of the
Company’s customer base, the impact of competition, the Company’s ability to sustain profitability and positive cash flows,
any delays or unanticipated expenses in connection with the operation of the Company’s Taiwan facility, the effect of foreign
economic, political, legal and other risks on the Company’s operations abroad, the uncertainty of patent litigation, the
increased government scrutiny on the Company’s agreements with brand pharmaceutical companies, consumer acceptance
and demand for new pharmaceutical products, the impact of market perceptions of the Company and the safety and quality of
the Company’s products, the difficulty of predicting FDA filings and approvals, the Company’s ability to achieve returns on its
investments in research and development activities, the Company’s inexperience in conducting clinical trials and submitting
new drug applications, the Company’s ability to successfully conduct clinical trials, the Company’s reliance on third parties to
conduct clinical trials and testing, impact of illegal distribution and sale by third parties of counterfeits or stolen products, the
availability of raw materials and impact of interruptions in the Company’s supply chain, the use of controlled substances in the
Company’s products, disruptions or failures in the Company’s information technology systems and network infrastructure, the
Company’s reliance on alliance and collaboration agreements, the Company’s dependence on certain employees, the
Company’s ability to comply with legal and regulatory requirements governing the healthcare industry, the regulatory
environment, the Company’s ability to protect its intellectual property, exposure to product liability claims, changes in tax
regulations, the Company’s ability to manage growth, including through potential acquisitions, the restrictions imposed by the
Company’s credit facility, uncertainties involved in the preparation of the Company’s financial statements, the Company’s
ability to maintain an effective system of internal control over financial reporting, the effect of terrorist attacks on the
Company’s business, the location of the Company’s manufacturing and research and development facilities near earthquake
fault lines and other risks described in the Company’s periodic reports filed with the Securities and Exchange
Commission. Forward-looking statements speak only as to the date on which they are made, and the Company undertakes no
obligation to update publicly or revise any forward-looking statement, regardless of whether new information becomes
available, future developments occur or otherwise.
Note: All product sales data included herein are derived from data published by IMS for the 12 months ended January 2013.
Trademarks referenced herein are the property of their respective owners.
©2013 Impax Laboratories, Inc. All Rights Reserved.
2
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.
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
 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
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
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
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
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
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.
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)
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
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
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
 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

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Cowen Co Health Care Conference March 6 2013

  • 1. Cowen & Co Health Care Conference March 6, 2013
  • 2. Safe Harbor Statement “Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995: To the extent any statements made in this presentation contain information that is not historical, these statements are forward- looking in nature and express the beliefs and expectations of management. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause the Company’s future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Such risks and uncertainties include, but are not limited to, the effect of current economic conditions on the Company’s industry, business, financial position and results of operations, fluctuations in revenues and operating income, the Company’s ability to promptly correct the issues raised in the warning letter and Form 483 observations received from the FDA, the Company’s ability to successfully develop and commercialize pharmaceutical products in a timely manner, reductions or loss of business with any significant customer, the impact of consolidation of the Company’s customer base, the impact of competition, the Company’s ability to sustain profitability and positive cash flows, any delays or unanticipated expenses in connection with the operation of the Company’s Taiwan facility, the effect of foreign economic, political, legal and other risks on the Company’s operations abroad, the uncertainty of patent litigation, the increased government scrutiny on the Company’s agreements with brand pharmaceutical companies, consumer acceptance and demand for new pharmaceutical products, the impact of market perceptions of the Company and the safety and quality of the Company’s products, the difficulty of predicting FDA filings and approvals, the Company’s ability to achieve returns on its investments in research and development activities, the Company’s inexperience in conducting clinical trials and submitting new drug applications, the Company’s ability to successfully conduct clinical trials, the Company’s reliance on third parties to conduct clinical trials and testing, impact of illegal distribution and sale by third parties of counterfeits or stolen products, the availability of raw materials and impact of interruptions in the Company’s supply chain, the use of controlled substances in the Company’s products, disruptions or failures in the Company’s information technology systems and network infrastructure, the Company’s reliance on alliance and collaboration agreements, the Company’s dependence on certain employees, the Company’s ability to comply with legal and regulatory requirements governing the healthcare industry, the regulatory environment, the Company’s ability to protect its intellectual property, exposure to product liability claims, changes in tax regulations, the Company’s ability to manage growth, including through potential acquisitions, the restrictions imposed by the Company’s credit facility, uncertainties involved in the preparation of the Company’s financial statements, the Company’s ability to maintain an effective system of internal control over financial reporting, the effect of terrorist attacks on the Company’s business, the location of the Company’s manufacturing and research and development facilities near earthquake fault lines and other risks described in the Company’s periodic reports filed with the Securities and Exchange Commission. Forward-looking statements speak only as to the date on which they are made, and the Company undertakes no obligation to update publicly or revise any forward-looking statement, regardless of whether new information becomes available, future developments occur or otherwise. Note: All product sales data included herein are derived from data published by IMS for the 12 months ended January 2013. Trademarks referenced herein are the property of their respective owners. ©2013 Impax Laboratories, Inc. All Rights Reserved. 2
  • 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