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33rd Annual J.P. Morgan
Healthcare Conference
January 13, 2015
Impax Cautionary Statement Regarding
Forward Looking Statements
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: 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 substantial
portion of our total revenues derived from sales of a limited number of products; 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 manufacturing facilities; the effect of foreign economic, political, legal, and other risks on the Company’s operations
abroad; the uncertainty of patent litigation and other legal proceedings; the increased government scrutiny on the Company’s agreements with brand pharmaceutical companies;
product development risks and the difficulty of predicting FDA filings and approvals; 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 Company’s determinations to discontinue the manufacture and distribution of certain
products; 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; the
Company’s lack of a license partner for commercialization of IPX066 outside of the United States; 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 Company’s policies regarding returns, allowances and chargebacks; the
use of controlled substances in the Company’s products; the effect of current economic conditions on our industry, business, results of operations and financial condition;
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 reliance on licenses to proprietary technologies; 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; risks
relating to goodwill and intangibles; changes in tax regulations; the Company’s ability to manage growth, including through potential acquisitions; the Company’s ability to meet
expectations regarding the timing and completion of the proposed transaction with Tower Holdings, Inc. and Lineage Therapeutics Inc.; the Company’s ability to consummate
such proposed transaction; the conditions to the completion of such proposed transaction (including the receipt of the regulatory approvals required for the transaction not being
obtained on the terms expected or on the anticipated schedule), the integration of the acquired business by the Company being more difficult, time-consuming or costly than
expected, operating costs, customer loss and business disruption (including, without limitation, difficulties in maintaining relationships with employees, customers, clients or
suppliers) being greater than expected following the proposed transaction, the retention of certain key employees of the acquired business being difficult, the Company’s and the
acquired business’s expected or targeted future financial and operating performance and results, the combined company’s capacity to bring new products to market, and the
possibility that the Company may be unable to achieve expected synergies and operating efficiencies in connection with such proposed transaction within the expected time-
frames or at all and to successfully integrate the acquired business, 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; expansion of social media platforms 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.
Trademarks referenced herein are the property of their respective owners.
©2014 Impax Laboratories, Inc. All Rights Reserved.
2
Integrated Specialty Pharmaceutical Company
Targeting complex, high-value, solid
oral and alternative dosage form
ANDAs
Focused on developing products for
unmet needs in the treatment of
Central Nervous System disorders
and other select specialty segments
Generic Pharmaceuticals
Branded Pharmaceuticals
3
Business Update - Four Core Areas of Focus
 Resolving FDA issues
 Fully implementing industry-best Quality Improvement Program
 Generic and Brand commercial success in 2014
 Revenue up 13% and EPS up 39% YTD September 2014
 Optimized resources by leveraging shared services
 Refocused internal Brand and Generic pipeline
 Proposed acquisition of CorePharma*
 Increased efficiency of the Balance Sheet
Focus on
Quality
Maximize
Dual Platform
Optimize
R&D
Business
Development
Acceleration
4
*CorePharma, LLC, Amedra Pharmaceuticals LLC, Lineage Therapeutics Inc. and Trail Services, Inc. (collectively CorePharma)
Multiple Opportunities to Drive Growth
5
Supported by
Strong Cash
Flow and
Balance Sheet
RYTARYTM
Generic
Pipeline
Proposed
Acquisition of
CorePharma*
Additional
Business
Development
and M&A
*CorePharma, LLC, Amedra Pharmaceuticals LLC, Lineage Therapeutics Inc. and Trail Services, Inc. (collectively CorePharma)
• Approved by FDA January 7th 2015
• Three years Hatch-Waxman exclusivity
• Four issued U.S. formulation patents
− One expires May 2022
− Three expire December 2028
6
RYTARY for Treatment of Parkinson’s Disease
RYTARY Attributes
7
Efficacy Clinical benefits include:
• Reduction in “OFF” time by 1.2 hours
• Increase in “ON” time without troublesome dyskinesia by 1.0 hour
• Significant improvement in motor function and Activities of Daily
Living (ADL)
Dosing • Oral capsule with 3x daily starting dose
• Ability to sprinkle contents of capsule on soft foods
PK
Characteristics
• RYTARY provides both an initial and extended levodopa plasma
concentrations after a single dose.
Two Clinical Phase III Studies Support Approval
In levodopa naïve patients RYTARY demonstrates significant improvements in:
• Combined scores of activities of daily living and motor function as measured by the
Unified Parkinson's Disease Rating Scale (UPDRS) Parts II and III
When studied against immediate-release carbidopa and levodopa comparator, RYTARY:
• Reduced mean “OFF” time by 1.2 hours
• Increased mean “ON” time with no or non-troublesome dyskinesia by 1.0 hour from
baseline to end of study compared with IR CD-LD
8
APEX-PD (N=381)
ADVANCED-PD (N=393)
The Parkinson’s Disease Market
$ millions; TRx millions; Source: IMS National Prescription Audit (NPA
Market Dynamics
9
Sales by Region
Sources: IMS; Decision Resources
• Significant global market with strong
future growth
• Carbidopa-Levodopa (CD-LD) is the
primary therapy for Parkinson’s
disease
• Significant unmet need for improved
CD-LD product that produces
relatively constant LD concentrations
• 87% of Parkinson’s disease patients
are taking CD-LD products
Parkinson’s Disease Sales and TRx
MAT Nov. 2014
$180
$67
$149
$296
Sales
CD/LD* COMT-I
Dopamine Agonists MAO-I
5.1
0.2
2.8
0.6
TRx
Sales
$700MM
TRx
8.7MM
Planning a Two Phase U.S. Product Launch
Phase 1
• Soft launch mid February 2015
• Product in distribution channel
• Limited samples to former clinical investigators and trained speakers
• Start Medicare Part D reimbursement process
• Initiate commercial coverage and reimbursement with managed care
Phase 2
• Full launch beginning early April 2015
• Field force promotion begins with 77 sales reps
• Focus on Top Tier Neurologists – approximately 8,100
10
Source: IMS NPA
Successfully Commercializing Zomig® Nasal Spray
+70% Revenue Growth
Nine Months Ended Sept. 2014 vs. Sept. 2013
Product
Nasal Triptan National Segment
Prescription Share
Share Growth
Since Impax
PromotionAug. 2012 Nov. 2014
Zomig® 23% 30% 28%
Imitrex® 5% 5% 5%
Generic Sumatriptan 72% 65% (9%)
A Track Record of Branded Commercial Success
11
RYTARY U.S. Market Assumptions and Growth
12
2015
• Full launch in 2Q
• Increase Sales Force to 77 reps from 64
• Marketing costs of approximately $13 million
• 8,100 target physicians
• Primary focus is existing carbidopa-levodopa patients
• Tier 2 or tier 3 formulary positioning with managed care
• Wholesale price between $15 to $17 per day
Critical U.S. Market Assumptions
*Projected based on current forecasts as of December 31, 2014.
2015E 2016E 2017E 2018E 2019E
RYTARY Projected U.S. Revenue Growth*
$275MM to $350MM
RYTARY Global Development Status
• Submitted Marketing Authorization Agreement on Nov. 7th 2014
‒ Deemed eligible as a “therapeutic innovation”
‒ Approval entitles the product to 10-year regulatory
exclusivity in Europe
‒ Accepted Nov. 26th 2014
• Active dialogue with potential ex-U.S. partners
13
A single integrated specialty pharmaceutical company
that builds on our collective strengths
14
Business Development Acceleration
Proposed Acquisition Adds Growth and Provides
Strategic and Financial Benefits
CorePharma, LLC, Amedra Pharmaceuticals LLC, Lineage Therapeutics Inc. and Trail Services, Inc. (collectively CorePharma)
18
Other SOD
9
Controlled-
Release SOD
10
Alternative
Dosage Form
Impax
37 Currently Marketed Products
Expands Generic Commercialized Portfolio
15
CorePharma/Lineage Therapeutics
11 Currently Marketed Products
9
Other SOD
1
Controlled-
Release SOD
1
Alternative
Dosage Form
Source: Data as of December 31, 2014
SOD = Solid Oral Dosage Form
Expands Generic Pipeline Opportunities
8
10
2
4
8
Impax CorePharma
22
10
ANDAs Pending at FDA Various Stages of Development
Current U.S. Brand/Generic market $13B sales
4
6
13
12
25
Impax CorePharma
22
38
Current U.S. Brand/Generic market $16B sales
12 Products Potential FTF or FTM
Source of sales data: IMS October 2014; Pipeline data as of December 31, 2014
FTF = First-to-File; FTM = First-to-Market; SOD = Solid Oral Dosage Form
2 Products Confirmed FTF or FTM
10 Products Potential FTF or FTM
Other SOD Controlled-Release SOD Alternative Dosage Form
16
Expands Potential Generic Launches in 2015
Assuming acquisition closes in First Quarter 2015
Current U.S. Brand/Generic market $2.2B sales
17
Source of sales data: IMS October 2014
*Requires approval from Hayward facility currently under a Warning Letter.
** Impax and CorePharma external partnered products
3* 3
2
1
4
4
Impax CorePharma External Partners**
Pending Approval Approved/Re-introduction
4
7
6
Impax
Generic
93%
Impax + CorePharma
Brand
7%
Generic
75%-80%
Brand
20%-25%
Grows and Diversifies Revenue Base
2014 Estimated Revenues 2015 Estimated Revenues
18
Acquisition Delivers in Primary Areas of Focus
 FDA approved and DEA licensed manufacturing facility
 Successful implementation of a Quality Improvement Program
 Lead Brand in a new therapeutic area
 High value Generic product line with near term new launches
 Focus on late stage & life cycle management Brand projects
 Significant near-term Generic opportunities
 Opportunity for optimization of combined R&D portfolio
 Strategic M&A transaction intended to enhance Shareholder value
 Balance sheet remains flexible for additional opportunities
Focus on
Quality
Maximize
Dual Platform
Optimize
R&D
Business
Development
Acceleration
19
Well Positioned for Growth
Targeting
Sustainable Generic
and Specialized
Brand Markets
Established Core
Competencies
Strong and Flexible
Financial Profile
20

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33rd Annual J.P. Morgan Healthcare Conference

  • 1. 33rd Annual J.P. Morgan Healthcare Conference January 13, 2015
  • 2. Impax Cautionary Statement Regarding Forward Looking Statements 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: 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 substantial portion of our total revenues derived from sales of a limited number of products; 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 manufacturing facilities; the effect of foreign economic, political, legal, and other risks on the Company’s operations abroad; the uncertainty of patent litigation and other legal proceedings; the increased government scrutiny on the Company’s agreements with brand pharmaceutical companies; product development risks and the difficulty of predicting FDA filings and approvals; 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 Company’s determinations to discontinue the manufacture and distribution of certain products; 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; the Company’s lack of a license partner for commercialization of IPX066 outside of the United States; 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 Company’s policies regarding returns, allowances and chargebacks; the use of controlled substances in the Company’s products; the effect of current economic conditions on our industry, business, results of operations and financial condition; 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 reliance on licenses to proprietary technologies; 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; risks relating to goodwill and intangibles; changes in tax regulations; the Company’s ability to manage growth, including through potential acquisitions; the Company’s ability to meet expectations regarding the timing and completion of the proposed transaction with Tower Holdings, Inc. and Lineage Therapeutics Inc.; the Company’s ability to consummate such proposed transaction; the conditions to the completion of such proposed transaction (including the receipt of the regulatory approvals required for the transaction not being obtained on the terms expected or on the anticipated schedule), the integration of the acquired business by the Company being more difficult, time-consuming or costly than expected, operating costs, customer loss and business disruption (including, without limitation, difficulties in maintaining relationships with employees, customers, clients or suppliers) being greater than expected following the proposed transaction, the retention of certain key employees of the acquired business being difficult, the Company’s and the acquired business’s expected or targeted future financial and operating performance and results, the combined company’s capacity to bring new products to market, and the possibility that the Company may be unable to achieve expected synergies and operating efficiencies in connection with such proposed transaction within the expected time- frames or at all and to successfully integrate the acquired business, 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; expansion of social media platforms 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. Trademarks referenced herein are the property of their respective owners. ©2014 Impax Laboratories, Inc. All Rights Reserved. 2
  • 3. Integrated Specialty Pharmaceutical Company Targeting complex, high-value, solid oral and alternative dosage form ANDAs Focused on developing products for unmet needs in the treatment of Central Nervous System disorders and other select specialty segments Generic Pharmaceuticals Branded Pharmaceuticals 3
  • 4. Business Update - Four Core Areas of Focus  Resolving FDA issues  Fully implementing industry-best Quality Improvement Program  Generic and Brand commercial success in 2014  Revenue up 13% and EPS up 39% YTD September 2014  Optimized resources by leveraging shared services  Refocused internal Brand and Generic pipeline  Proposed acquisition of CorePharma*  Increased efficiency of the Balance Sheet Focus on Quality Maximize Dual Platform Optimize R&D Business Development Acceleration 4 *CorePharma, LLC, Amedra Pharmaceuticals LLC, Lineage Therapeutics Inc. and Trail Services, Inc. (collectively CorePharma)
  • 5. Multiple Opportunities to Drive Growth 5 Supported by Strong Cash Flow and Balance Sheet RYTARYTM Generic Pipeline Proposed Acquisition of CorePharma* Additional Business Development and M&A *CorePharma, LLC, Amedra Pharmaceuticals LLC, Lineage Therapeutics Inc. and Trail Services, Inc. (collectively CorePharma)
  • 6. • Approved by FDA January 7th 2015 • Three years Hatch-Waxman exclusivity • Four issued U.S. formulation patents − One expires May 2022 − Three expire December 2028 6 RYTARY for Treatment of Parkinson’s Disease
  • 7. RYTARY Attributes 7 Efficacy Clinical benefits include: • Reduction in “OFF” time by 1.2 hours • Increase in “ON” time without troublesome dyskinesia by 1.0 hour • Significant improvement in motor function and Activities of Daily Living (ADL) Dosing • Oral capsule with 3x daily starting dose • Ability to sprinkle contents of capsule on soft foods PK Characteristics • RYTARY provides both an initial and extended levodopa plasma concentrations after a single dose.
  • 8. Two Clinical Phase III Studies Support Approval In levodopa naïve patients RYTARY demonstrates significant improvements in: • Combined scores of activities of daily living and motor function as measured by the Unified Parkinson's Disease Rating Scale (UPDRS) Parts II and III When studied against immediate-release carbidopa and levodopa comparator, RYTARY: • Reduced mean “OFF” time by 1.2 hours • Increased mean “ON” time with no or non-troublesome dyskinesia by 1.0 hour from baseline to end of study compared with IR CD-LD 8 APEX-PD (N=381) ADVANCED-PD (N=393)
  • 9. The Parkinson’s Disease Market $ millions; TRx millions; Source: IMS National Prescription Audit (NPA Market Dynamics 9 Sales by Region Sources: IMS; Decision Resources • Significant global market with strong future growth • Carbidopa-Levodopa (CD-LD) is the primary therapy for Parkinson’s disease • Significant unmet need for improved CD-LD product that produces relatively constant LD concentrations • 87% of Parkinson’s disease patients are taking CD-LD products Parkinson’s Disease Sales and TRx MAT Nov. 2014 $180 $67 $149 $296 Sales CD/LD* COMT-I Dopamine Agonists MAO-I 5.1 0.2 2.8 0.6 TRx Sales $700MM TRx 8.7MM
  • 10. Planning a Two Phase U.S. Product Launch Phase 1 • Soft launch mid February 2015 • Product in distribution channel • Limited samples to former clinical investigators and trained speakers • Start Medicare Part D reimbursement process • Initiate commercial coverage and reimbursement with managed care Phase 2 • Full launch beginning early April 2015 • Field force promotion begins with 77 sales reps • Focus on Top Tier Neurologists – approximately 8,100 10
  • 11. Source: IMS NPA Successfully Commercializing Zomig® Nasal Spray +70% Revenue Growth Nine Months Ended Sept. 2014 vs. Sept. 2013 Product Nasal Triptan National Segment Prescription Share Share Growth Since Impax PromotionAug. 2012 Nov. 2014 Zomig® 23% 30% 28% Imitrex® 5% 5% 5% Generic Sumatriptan 72% 65% (9%) A Track Record of Branded Commercial Success 11
  • 12. RYTARY U.S. Market Assumptions and Growth 12 2015 • Full launch in 2Q • Increase Sales Force to 77 reps from 64 • Marketing costs of approximately $13 million • 8,100 target physicians • Primary focus is existing carbidopa-levodopa patients • Tier 2 or tier 3 formulary positioning with managed care • Wholesale price between $15 to $17 per day Critical U.S. Market Assumptions *Projected based on current forecasts as of December 31, 2014. 2015E 2016E 2017E 2018E 2019E RYTARY Projected U.S. Revenue Growth* $275MM to $350MM
  • 13. RYTARY Global Development Status • Submitted Marketing Authorization Agreement on Nov. 7th 2014 ‒ Deemed eligible as a “therapeutic innovation” ‒ Approval entitles the product to 10-year regulatory exclusivity in Europe ‒ Accepted Nov. 26th 2014 • Active dialogue with potential ex-U.S. partners 13
  • 14. A single integrated specialty pharmaceutical company that builds on our collective strengths 14 Business Development Acceleration Proposed Acquisition Adds Growth and Provides Strategic and Financial Benefits CorePharma, LLC, Amedra Pharmaceuticals LLC, Lineage Therapeutics Inc. and Trail Services, Inc. (collectively CorePharma)
  • 15. 18 Other SOD 9 Controlled- Release SOD 10 Alternative Dosage Form Impax 37 Currently Marketed Products Expands Generic Commercialized Portfolio 15 CorePharma/Lineage Therapeutics 11 Currently Marketed Products 9 Other SOD 1 Controlled- Release SOD 1 Alternative Dosage Form Source: Data as of December 31, 2014 SOD = Solid Oral Dosage Form
  • 16. Expands Generic Pipeline Opportunities 8 10 2 4 8 Impax CorePharma 22 10 ANDAs Pending at FDA Various Stages of Development Current U.S. Brand/Generic market $13B sales 4 6 13 12 25 Impax CorePharma 22 38 Current U.S. Brand/Generic market $16B sales 12 Products Potential FTF or FTM Source of sales data: IMS October 2014; Pipeline data as of December 31, 2014 FTF = First-to-File; FTM = First-to-Market; SOD = Solid Oral Dosage Form 2 Products Confirmed FTF or FTM 10 Products Potential FTF or FTM Other SOD Controlled-Release SOD Alternative Dosage Form 16
  • 17. Expands Potential Generic Launches in 2015 Assuming acquisition closes in First Quarter 2015 Current U.S. Brand/Generic market $2.2B sales 17 Source of sales data: IMS October 2014 *Requires approval from Hayward facility currently under a Warning Letter. ** Impax and CorePharma external partnered products 3* 3 2 1 4 4 Impax CorePharma External Partners** Pending Approval Approved/Re-introduction 4 7 6
  • 18. Impax Generic 93% Impax + CorePharma Brand 7% Generic 75%-80% Brand 20%-25% Grows and Diversifies Revenue Base 2014 Estimated Revenues 2015 Estimated Revenues 18
  • 19. Acquisition Delivers in Primary Areas of Focus  FDA approved and DEA licensed manufacturing facility  Successful implementation of a Quality Improvement Program  Lead Brand in a new therapeutic area  High value Generic product line with near term new launches  Focus on late stage & life cycle management Brand projects  Significant near-term Generic opportunities  Opportunity for optimization of combined R&D portfolio  Strategic M&A transaction intended to enhance Shareholder value  Balance sheet remains flexible for additional opportunities Focus on Quality Maximize Dual Platform Optimize R&D Business Development Acceleration 19
  • 20. Well Positioned for Growth Targeting Sustainable Generic and Specialized Brand Markets Established Core Competencies Strong and Flexible Financial Profile 20