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Credit Suisse Healthcare
Conference
November 14, 2012
…Improving Health Through Technology
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 the
Company’s revenues and operating income, the Company’s ability to successfully develop and commercialize pharmaceutical
products, 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, increased government
scrutiny on the Company’s agreements with brand pharmaceutical companies, consumer acceptance and demand for new
pharmaceutical products, the difficulty of predicting Food and Drug Administration filings and approvals, 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, 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 the Company’s intellectual property, exposure to product liability claims, changes in tax regulations, the Company’s
ability to manage the Company’s 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, any manufacturing difficulties or delays, 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 Impax
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 Wolters Kluwer Health for the 12 months
ended September 2012.
Trademarks referenced herein are the property of their respective owners.
©2012 Impax Laboratories, Inc. All Rights Reserved.
3
Impax’s Dual Strategic Focus
Unique targeted ANDAs
First-to-File, First-to-Market
Sustainability through
technically challenging,
difficult to formulate products
Partnership for in-licensing
or co-development of
alternative dosage forms
45 apps pending at FDA
24 under development
Create valued CNS products
Develop strong IP positions
IPX066 (RYTARYTM) NDA
filed 4Q11 as 505(b)(2) filing
IPX159 in Phase IIb as
505(b)(1) filing
Licensed exclusive U.S.
commercialization rights to
Zomig®
Note: Data as of November 1, 2012
Healthy Balance Sheet Supports Ongoing M&A
4
Generic & Brand M&A Candidates
Manageable
Execution
Risk
Financially
Attractive
Strategically
Right
Significant cash and no debt for investments in growth initiatives
…A Leader in Generic Medicines
Dr. Carole Ben-Maimon
President, Global Pharmaceuticals
Generic Growth Initiatives
6
69 Products Pending or Under Development
7
48
Currently
Marketed
ANDAs 24
Under Development
($5 Billion)
45
Pending at FDA
($20 Billion)
Present
Future Targeted Opportunities
$25 Billion Current U.S. Brand/Generic Sales
Note: All product sales data included herein are derived from data published by
Wolters Kluwer Health for the 12 months ended September 2012.
• 2 softgel capsule products pending at FDA
8
• 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 development
Alternative Dosage Form Partnership Portfolio
Currently ADF portfolio of 24 products:
– 9 approved
– 6 pending at the FDA
– 9 under development
Brand and Generic sales >$2.7B…a number
of them still First-to-File or First-to-Market
opportunities
Note: All product sales data included herein are derived from data published by
Wolters Kluwer Health for the 12 months ended September 2012.
9
2013
• Original Opana ER® (FTF – 6 months exclusivity expected)
• Doryx®
• Concerta®
• Numerous undisclosed pending ANDA opportunities
2014
• Trilipix®
• Renvela® tablets (FTF - 6 months exclusivity expected)
• Numerous undisclosed pending ANDA opportunities
2015
• Welchol® tablets (3 months exclusivity expected)
• Numerous undisclosed pending ANDA opportunities
Note: Original Opana ER® ANDA currently approved. Commercialization of pending ANDAs
will depend on FDA approval and market dynamics at time of approval.
A Snapshot of Generic Launch Opportunities
…Advancing CNS Treatment
Michael Nestor
President, Impax Pharmaceuticals
11
Brand Growth Initiatives
Internal R&D
Programs
Approval and launch
of RytaryTM in U.S.
Market
Zomig® in U.S.
12
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”
13
RYTARYTM (IPX066): Next Steps in 2012/1Q13
Dec.
2011
Feb.
2012
Throughout 2012/1Q13
NDA
filed
Pre-launch
preparation and
launch planning
 Building
marketing and
sales team
 Conducting
commercial pre-
launch activities
 Prepare for
launch in 1Q13
FDA
acceptance
of NDA
Filing
PDUFA
Date
Jan. 21,
2013(a)
Development Milestones
1st patent granted
 Aug. 2006
 Expires May 2022
2nd patent submission
 Dec. 2008
 Expires Dec. 2028
Formulation Patent
Information
(a) The Company announced on Oct. 12, 2012 that the FDA extended the PDUFA date three
months to review additional requested information. The initial PDUFA date was Oct. 21, 2012.
14
Clinical Stage Pipeline - IPX159
IPX159 – Restless Legs Syndrome (RLS)
IPX159
Development
Overview
Product
Overview
• Ex-US compound (for a different indication), NCE US
• Inhibits uptake of neurotransmitters
RLS Market
Opportunity
US registration path 505(b)(1) – 5 year regulatory exclusivity
Significant Commercial Opportunity
Large
opportunity in
the U.S.
Improve
Treatment
Opportunity
25 million in
U.S.
experience
RLS
symptoms
~$800 million
total
prescription
market size
Good
commercial fit
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”
Phase IIb study underway
15
IPX159: Development Status
Preclinical & POC Phase I Phase IIa Phase IIb – Initiated December 2011
Completed
Completed
Completed
• Primary endpoint: International Restless
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 quarter 2013
16
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
17
Strong Platform for Long Term Growth
Unique Targeted
High Value ANDAs
Offering Long-Term
Growth Drivers
Generic Brand
Drug Delivery
Expertise
Product
Development
Formulation
Technology
Core Competency

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Credit Suisse Healthcare Conference

  • 1. Credit Suisse Healthcare Conference November 14, 2012 …Improving Health Through Technology
  • 2. 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 the Company’s revenues and operating income, the Company’s ability to successfully develop and commercialize pharmaceutical products, 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, increased government scrutiny on the Company’s agreements with brand pharmaceutical companies, consumer acceptance and demand for new pharmaceutical products, the difficulty of predicting Food and Drug Administration filings and approvals, 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, 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 the Company’s intellectual property, exposure to product liability claims, changes in tax regulations, the Company’s ability to manage the Company’s 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, any manufacturing difficulties or delays, 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 Impax 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 Wolters Kluwer Health for the 12 months ended September 2012. Trademarks referenced herein are the property of their respective owners. ©2012 Impax Laboratories, Inc. All Rights Reserved.
  • 3. 3 Impax’s Dual Strategic Focus Unique targeted ANDAs First-to-File, First-to-Market Sustainability through technically challenging, difficult to formulate products Partnership for in-licensing or co-development of alternative dosage forms 45 apps pending at FDA 24 under development Create valued CNS products Develop strong IP positions IPX066 (RYTARYTM) NDA filed 4Q11 as 505(b)(2) filing IPX159 in Phase IIb as 505(b)(1) filing Licensed exclusive U.S. commercialization rights to Zomig® Note: Data as of November 1, 2012
  • 4. Healthy Balance Sheet Supports Ongoing M&A 4 Generic & Brand M&A Candidates Manageable Execution Risk Financially Attractive Strategically Right Significant cash and no debt for investments in growth initiatives
  • 5. …A Leader in Generic Medicines Dr. Carole Ben-Maimon President, Global Pharmaceuticals
  • 7. 69 Products Pending or Under Development 7 48 Currently Marketed ANDAs 24 Under Development ($5 Billion) 45 Pending at FDA ($20 Billion) Present Future Targeted Opportunities $25 Billion Current U.S. Brand/Generic Sales Note: All product sales data included herein are derived from data published by Wolters Kluwer Health for the 12 months ended September 2012.
  • 8. • 2 softgel capsule products pending at FDA 8 • 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 development Alternative Dosage Form Partnership Portfolio Currently ADF portfolio of 24 products: – 9 approved – 6 pending at the FDA – 9 under development Brand and Generic sales >$2.7B…a number of them still First-to-File or First-to-Market opportunities Note: All product sales data included herein are derived from data published by Wolters Kluwer Health for the 12 months ended September 2012.
  • 9. 9 2013 • Original Opana ER® (FTF – 6 months exclusivity expected) • Doryx® • Concerta® • Numerous undisclosed pending ANDA opportunities 2014 • Trilipix® • Renvela® tablets (FTF - 6 months exclusivity expected) • Numerous undisclosed pending ANDA opportunities 2015 • Welchol® tablets (3 months exclusivity expected) • Numerous undisclosed pending ANDA opportunities Note: Original Opana ER® ANDA currently approved. Commercialization of pending ANDAs will depend on FDA approval and market dynamics at time of approval. A Snapshot of Generic Launch Opportunities
  • 10. …Advancing CNS Treatment Michael Nestor President, Impax Pharmaceuticals
  • 11. 11 Brand Growth Initiatives Internal R&D Programs Approval and launch of RytaryTM in U.S. Market Zomig® in U.S.
  • 12. 12 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”
  • 13. 13 RYTARYTM (IPX066): Next Steps in 2012/1Q13 Dec. 2011 Feb. 2012 Throughout 2012/1Q13 NDA filed Pre-launch preparation and launch planning  Building marketing and sales team  Conducting commercial pre- launch activities  Prepare for launch in 1Q13 FDA acceptance of NDA Filing PDUFA Date Jan. 21, 2013(a) Development Milestones 1st patent granted  Aug. 2006  Expires May 2022 2nd patent submission  Dec. 2008  Expires Dec. 2028 Formulation Patent Information (a) The Company announced on Oct. 12, 2012 that the FDA extended the PDUFA date three months to review additional requested information. The initial PDUFA date was Oct. 21, 2012.
  • 14. 14 Clinical Stage Pipeline - IPX159 IPX159 – Restless Legs Syndrome (RLS) IPX159 Development Overview Product Overview • Ex-US compound (for a different indication), NCE US • Inhibits uptake of neurotransmitters RLS Market Opportunity US registration path 505(b)(1) – 5 year regulatory exclusivity Significant Commercial Opportunity Large opportunity in the U.S. Improve Treatment Opportunity 25 million in U.S. experience RLS symptoms ~$800 million total prescription market size Good commercial fit 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” Phase IIb study underway
  • 15. 15 IPX159: Development Status Preclinical & POC Phase I Phase IIa Phase IIb – Initiated December 2011 Completed Completed Completed • Primary endpoint: International Restless 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 quarter 2013
  • 16. 16 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
  • 17. 17 Strong Platform for Long Term Growth Unique Targeted High Value ANDAs Offering Long-Term Growth Drivers Generic Brand Drug Delivery Expertise Product Development Formulation Technology Core Competency