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Credit Suisse
Healthcare Conference
November 14, 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 forwardlooking 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. Forwardlooking 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 September 2013.
Trademarks referenced herein are the property of their respective owners.
©2013 Impax Laboratories, Inc. All Rights Reserved.
2
Positioned for Future Growth
Targeting
Sustainable
Generic and
Specialized
Brand Markets
Established
Core
Competencies

Strong and
Flexible
Financial Profile
3

 Generic pipeline targeting $26B U.S. sales
 Brand pipeline focused on Central Nervous System (CNS)
 Solid platform on which to build long-term growth

 Track record of complex formulation and development
 Established drug delivery capabilities
 Hatch-Waxman expertise and Paragraph IV successes

 Diversifying Generic business product mix
 Building a Branded business pipeline
 Financial resources and flexibility to support growth

Note: All brand/generic product sales data included herein are derived from data published by IMS for the 12 months ended September 2013.
Two Platforms for Growth

Generic Platform
 Unique targeted ANDAs

Branded Platform
 Creating highly valued CNS products

• Solid Oral Dosage (SOD)

 RYTARYTM – NDA pending approval

• Alternative Dosage Form (ADF)

 Commercializing Zomig® in the U.S.

 First-to-File/First-to-Market emphasis

 Partnerships/M&A areas

 Focusing on sustainable products

• Neurology

 Partnerships/M&A primarily on ADFs

• Psychiatry

 69 products pending at FDA or
under development

4

Note: Data as of October 2013.

 Building a product pipeline
 Developing strong IP positions
Strategy to Create Long Term Growth
Revenue Growth
Opportunities

Operational
Improvements

Diversifying Generic
Business product mix

Focusing on improving
quality and compliance

Focusing on building a
Brand pipeline

Right-sizing manufacturing
costs and capacity

Executing business
development and M&A
activities

Enhancing management
team across the company

Supported by financial resources and strong balance sheet:
approximately $437MM cash/cash equivalents and no debt
5

Note: Data as of September 30, 2013,.
Committed to Improving Our Operations
• Quality first culture
• Management and organization structure changes
• Initiated an internal Quality Improvement Program (QIP)
• Working aggressively to complete key aspects of the QIP
• Third-party experts continue to assist us with:
– Review of our manufacturing and quality systems
– Enhancing our systems and standards
• Committed to resolving all observations and exceeding
current Good Manufacturing Practice

6
Strategic Initiatives for Generic Growth

Focusing on…
Organic Growth
through SOD and
ADF Forms

Organic Growth
Partnership
Both Solid Oral &
Mainly in ADF
Alternative Dosage
Forms (ADF)

7

Strategic Partnerships
Primarily
in ADFs

Strategic M & A
M&A
MainlyPrimarily
in ADF
in ADFs
2013 Generic Product Launches
January

Oxymorphone Hydrochloride ER tablets
5, 7.5, 10, 15, 20, 30 and 40 mg

May

Authorized generic Zomig® tablets
Authorized generic Zomig® Orally Disintegrating Tablets
2.5 and 5 mg

July
Authorized generic Trilipix® Delayed Release Capsules
45 and 135 mg

Shortly…
Solaraze® Gel 3%
8
Diversifying Currently Marketed Portfolio
47 Currently Marketed Products
Alternative
Dosage Form
19%

13

9

25

Other Solid Oral
53%

9

Note: Data as of October 2013.

Controlled-Release
Solid Oral
28%
Diversifying Generic Product Pipeline
69 Future Opportunities Pending at FDA or Under Development
$26B Current U.S. Brand/Generic Sales

42
4

27

22
15
16
Pending at FDA
19 Total ADF
28% of Pipeline
10

10
2
Under Development
32 Total C-R SO
46% of Pipeline

18 Total Other SO
26% of Pipeline

Note: Date as of October 2013. All product sales data included herein are derived from data published by IMS for the 12 months ended September 2013.
Strategic Initiatives for Brand Growth

Focusing on…
Organic Growth
through SOD and
ADF Forms

Organic Growth
Partnership
Mainly in
Primarily in ADF
Neurology Area

11

Partnerships
Neurology &
Psychiatry Areas

M&A

M&A
Neurology
Mainly in ADF &

Psychiatry Areas
(Products/Companies)
Building a Brand Product Pipeline

PROJECT

PHASE I OR POC

PHASE II

IPX232
IPX…

APPROVED

Parkinson’s Disease (carbidopa-levodopa)

RYTARYTM (a)

IPX231

REGISTRATION

Migraine

Zomig®

IPX203

PHASE III

Parkinson’s Disease
Parkinson’s Disease
Migraine
Exploratory Projects

(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.

12
RYTARYTM (IPX066):
Carbidopa and Levodopa Extended-Release Capsule
PATENT
INFORMATION

DEC.
2011

FEB.
2012

JAN. 21,
2013(a)

THROUGHOUT
2013

RYTARY™ (IPX066) for the Symptomatic Treatment of Parkinson’s Disease

1st Patent Granted
 Aug. 2006
 Expires May 2022

2nd Patent Granted
 Dec. 2008
 Expires Dec. 2028

PDUFA Date
FDA
- Received
NDA Acceptance
Complete
of NDA
Filed
Response
Filing
Letter

Pre-launch planning

More than one million people in the U.S., with 50,000-60,000
new cases diagnosed each year in the U.S. alone

13

(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
Continuing Our Commercial Success
Building relationships with neurologists since July 2006
 Licensed exclusive U.S. commercialization rights to Zomig®
 Began commercializing Zomig® in April 2012
o Tablet and ZMT patents expired May 2013
 Continuing commercialization of Zomig® Nasal Spray
o Nasal Spray patent expires May 2021
Since Impax Promotion
April ’12 to Sept. ‘13

Nasal Triptan Market Share, National
80%

Sumatriptan
-5% decrease

70%
60%
50%

Zomig®
+17% increase

40%
30%

Imitrex®
-7% decrease

20%
10%

14

Source: IMS NPA Weekly

Sep-13

Aug-13

Jul-13

Jun-13

May-13

Apr-13

Mar-13

Feb-13

Jan-13

Dec-12

Nov-12

Oct-12

Sep-12

Aug-12

Jul-12

Jun-12

May-12

Apr-12

Mar-12

Feb-12

Jan-12

Dec-11

Nov-11

Oct-11

0%
Positioned for Future Growth
Targeting
Sustainable
Generic and
Specialized
Brand Markets
Established
Core
Competencies

Strong and
Flexible
Financial Profile

 Generic pipeline targeting $26B U.S. sales
 Brand pipeline focused on Central Nervous System (CNS)
 Solid platform on which to build long-term growth

 Track record of complex formulation and development
 Established drug delivery capabilities
 Hatch-Waxman expertise and Paragraph IV successes

 Diversifying Generic business product mix
 Building a Branded business pipeline
 Financial resources and flexibility to support growth

15 Note: All brand/generic product sales data included herein are derived from data published by IMS for the 12 months ended September 2013.

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Impax Laboratories Credit Suisse 2013 Healthcare Conference November 14, 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 forwardlooking 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. Forwardlooking 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 September 2013. Trademarks referenced herein are the property of their respective owners. ©2013 Impax Laboratories, Inc. All Rights Reserved. 2
  • 3. Positioned for Future Growth Targeting Sustainable Generic and Specialized Brand Markets Established Core Competencies Strong and Flexible Financial Profile 3  Generic pipeline targeting $26B U.S. sales  Brand pipeline focused on Central Nervous System (CNS)  Solid platform on which to build long-term growth  Track record of complex formulation and development  Established drug delivery capabilities  Hatch-Waxman expertise and Paragraph IV successes  Diversifying Generic business product mix  Building a Branded business pipeline  Financial resources and flexibility to support growth Note: All brand/generic product sales data included herein are derived from data published by IMS for the 12 months ended September 2013.
  • 4. Two Platforms for Growth Generic Platform  Unique targeted ANDAs Branded Platform  Creating highly valued CNS products • Solid Oral Dosage (SOD)  RYTARYTM – NDA pending approval • Alternative Dosage Form (ADF)  Commercializing Zomig® in the U.S.  First-to-File/First-to-Market emphasis  Partnerships/M&A areas  Focusing on sustainable products • Neurology  Partnerships/M&A primarily on ADFs • Psychiatry  69 products pending at FDA or under development 4 Note: Data as of October 2013.  Building a product pipeline  Developing strong IP positions
  • 5. Strategy to Create Long Term Growth Revenue Growth Opportunities Operational Improvements Diversifying Generic Business product mix Focusing on improving quality and compliance Focusing on building a Brand pipeline Right-sizing manufacturing costs and capacity Executing business development and M&A activities Enhancing management team across the company Supported by financial resources and strong balance sheet: approximately $437MM cash/cash equivalents and no debt 5 Note: Data as of September 30, 2013,.
  • 6. Committed to Improving Our Operations • Quality first culture • Management and organization structure changes • Initiated an internal Quality Improvement Program (QIP) • Working aggressively to complete key aspects of the QIP • Third-party experts continue to assist us with: – Review of our manufacturing and quality systems – Enhancing our systems and standards • Committed to resolving all observations and exceeding current Good Manufacturing Practice 6
  • 7. Strategic Initiatives for Generic Growth Focusing on… Organic Growth through SOD and ADF Forms Organic Growth Partnership Both Solid Oral & Mainly in ADF Alternative Dosage Forms (ADF) 7 Strategic Partnerships Primarily in ADFs Strategic M & A M&A MainlyPrimarily in ADF in ADFs
  • 8. 2013 Generic Product Launches January Oxymorphone Hydrochloride ER tablets 5, 7.5, 10, 15, 20, 30 and 40 mg May Authorized generic Zomig® tablets Authorized generic Zomig® Orally Disintegrating Tablets 2.5 and 5 mg July Authorized generic Trilipix® Delayed Release Capsules 45 and 135 mg Shortly… Solaraze® Gel 3% 8
  • 9. Diversifying Currently Marketed Portfolio 47 Currently Marketed Products Alternative Dosage Form 19% 13 9 25 Other Solid Oral 53% 9 Note: Data as of October 2013. Controlled-Release Solid Oral 28%
  • 10. Diversifying Generic Product Pipeline 69 Future Opportunities Pending at FDA or Under Development $26B Current U.S. Brand/Generic Sales 42 4 27 22 15 16 Pending at FDA 19 Total ADF 28% of Pipeline 10 10 2 Under Development 32 Total C-R SO 46% of Pipeline 18 Total Other SO 26% of Pipeline Note: Date as of October 2013. All product sales data included herein are derived from data published by IMS for the 12 months ended September 2013.
  • 11. Strategic Initiatives for Brand Growth Focusing on… Organic Growth through SOD and ADF Forms Organic Growth Partnership Mainly in Primarily in ADF Neurology Area 11 Partnerships Neurology & Psychiatry Areas M&A M&A Neurology Mainly in ADF & Psychiatry Areas (Products/Companies)
  • 12. Building a Brand Product Pipeline PROJECT PHASE I OR POC PHASE II IPX232 IPX… APPROVED Parkinson’s Disease (carbidopa-levodopa) RYTARYTM (a) IPX231 REGISTRATION Migraine Zomig® IPX203 PHASE III Parkinson’s Disease Parkinson’s Disease Migraine Exploratory Projects (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. 12
  • 13. RYTARYTM (IPX066): Carbidopa and Levodopa Extended-Release Capsule PATENT INFORMATION DEC. 2011 FEB. 2012 JAN. 21, 2013(a) THROUGHOUT 2013 RYTARY™ (IPX066) for the Symptomatic Treatment of Parkinson’s Disease 1st Patent Granted  Aug. 2006  Expires May 2022 2nd Patent Granted  Dec. 2008  Expires Dec. 2028 PDUFA Date FDA - Received NDA Acceptance Complete of NDA Filed Response Filing Letter Pre-launch planning More than one million people in the U.S., with 50,000-60,000 new cases diagnosed each year in the U.S. alone 13 (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
  • 14. Continuing Our Commercial Success Building relationships with neurologists since July 2006  Licensed exclusive U.S. commercialization rights to Zomig®  Began commercializing Zomig® in April 2012 o Tablet and ZMT patents expired May 2013  Continuing commercialization of Zomig® Nasal Spray o Nasal Spray patent expires May 2021 Since Impax Promotion April ’12 to Sept. ‘13 Nasal Triptan Market Share, National 80% Sumatriptan -5% decrease 70% 60% 50% Zomig® +17% increase 40% 30% Imitrex® -7% decrease 20% 10% 14 Source: IMS NPA Weekly Sep-13 Aug-13 Jul-13 Jun-13 May-13 Apr-13 Mar-13 Feb-13 Jan-13 Dec-12 Nov-12 Oct-12 Sep-12 Aug-12 Jul-12 Jun-12 May-12 Apr-12 Mar-12 Feb-12 Jan-12 Dec-11 Nov-11 Oct-11 0%
  • 15. Positioned for Future Growth Targeting Sustainable Generic and Specialized Brand Markets Established Core Competencies Strong and Flexible Financial Profile  Generic pipeline targeting $26B U.S. sales  Brand pipeline focused on Central Nervous System (CNS)  Solid platform on which to build long-term growth  Track record of complex formulation and development  Established drug delivery capabilities  Hatch-Waxman expertise and Paragraph IV successes  Diversifying Generic business product mix  Building a Branded business pipeline  Financial resources and flexibility to support growth 15 Note: All brand/generic product sales data included herein are derived from data published by IMS for the 12 months ended September 2013.