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. A Strong Year for Impax
4
$512
$596
2013 2014
$115
$187
2013 2014
$0.82
$1.32
2013 2014
Revenue
Growth – 17%
Adjusted EBITDA
Growth – 63%
Adjusted EPS
Growth - 61%
$ in millions except EPS
5. Impax Business Update - Key Areas of Focus
Resolving Impax FDA issues
Fully implementing industry-best Quality Improvement Program
Generic and Brand commercial success in 2014
Revenue up 17% and adjusted EPS up 61% in 2014
Optimized resources by leveraging shared services
Refocused internal Brand and Generic pipeline
Acquisition of Tower/Lineage*
Increased efficiency of the Balance Sheet
Focus on
Quality
Maximize
Dual Platform
Optimize
R&D
Business
Development
Acceleration
*CorePharma, LLC, Amedra Pharmaceuticals LLC, Lineage Therapeutics Inc. and Trail Services, Inc. (collectively Tower/Lineage)
5
6. Multiple Opportunities to Drive Growth
6
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)
7. • 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
7
RYTARY for Treatment of Parkinson’s Disease
8. RYTARY Attributes
8
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.
9. 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
9
APEX-PD (N=381)
ADVANCED-PD (N=393)
10. The Parkinson’s Disease Market
$ millions; TRx millions; Source: IMS National Prescription Audit (NPA
Market Dynamics
10
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
11. Planning a Two Phase U.S. Product Launch
Phase 1
• Soft launch February 10, 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
11
12. Source: IMS NPA
Successfully Commercializing Zomig® Nasal Spray
+39% Revenue Growth
2014 vs. 2013
Product
Nasal Triptan National Segment
Prescription Share
Share Growth
Since Impax
PromotionAug. 2012 Dec. 2014
Zomig® 23% 31% 34%
Imitrex® 5% 6% 6%
Generic Sumatriptan 72% 63% (11%)
A Track Record of Branded Commercial Success
12
13. RYTARY U.S. Market Assumptions and Growth
13
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
14. 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
14
15. A single integrated specialty pharmaceutical company
that builds on our collective strengths
15
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)
16. 17
Other SOD
9
Controlled-
Release SOD
10
Alternative
Dosage Form
Impax
36 Currently Marketed Products
Expands Generic Commercialized Portfolio
16
CorePharma*
11 Currently Marketed Products
9
Other SOD
1
Controlled-
Release SOD
1
Alternative
Dosage Form
Source: Data as of February 26, 2015; SOD = Solid Oral Dosage Form
*CorePharma, LLC and Lineage Therapeutics Inc.
17. Expands Generic Pipeline Opportunities
7
10
2
4
8
Impax CorePharma
21
10
ANDAs Pending at FDA Various Stages of Development
Current U.S. Brand/Generic market $13B sales
3
6
13
12
25
Impax CorePharma
21
38
Current U.S. Brand/Generic market $16B sales
12 Products Potential FTF or FTM
Source of sales data: IMS December 2014; Pipeline data as of February 26, 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
17
18. Expands Potential Generic Launches in 2015
Assuming acquisition closes in First Quarter 2015
Current U.S. Brand/Generic market $2.2B sales
18
Source of sales data: IMS December 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
20. 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
20
21. Well Positioned for Growth
Targeting
Sustainable Generic
and Specialized
Brand Markets
Established Core
Competencies
Strong and Flexible
Financial Profile
21
22. Reconciliation of GAAP to Non-GAAP Results
The following table reconciles reported net income to
adjusted net income. (Unaudited, amounts in thousands,
except per share data)
Year Ended
December 31,
2014 2013
Net income $ 57,353 $ 101,259
Adjusted to add (deduct):
Amortization 11,082 16,374
Business development expenses 9,068 -
Hayward facility remediation costs 23,686 25,931
Employee severance 5,003 7,988
Payments received from litigation settlement - (153,049)
Intangible asset impairment charges 2,876 13,906
Provision for inventory reserve - 18,053
R&D partner milestone payment - 2,000
Loss on asset disposal - 881
Payment for licensing agreement 2,000 -
Income tax effect (17,863) 22,769
Adjusted net income $ 93,205 $ 56,112
Adjusted net income per diluted share $ 1.32 $ 0.82
Net income (loss) per diluted share $ 0.81 $ 1.47
Year Ended
December 31,
2014 2013
Net income $ 57,353 $ 101,259
Adjusted to add (deduct):
Interest income (1,473) (1,299)
Interest expense 43 419
Depreciation and other 22,944 19,632
Income tax (benefit) expense 33,206 45,681
EBITDA 112,073 165,692
Adjusted to add (deduct):
Amortization 11,082 16,374
Business development expenses 9,068 -
Hayward facility remediation costs 23,686 25,931
Employee severance 5,003 7,988
Payments received from litigation settlement - (153,049)
Intangible asset impairment charges 2,876 13,906
Provision for inventory reserve - 18,053
R&D partner milestone payment - 2,000
Loss on asset disposal - 881
Payment for licensing agreement 2,000 -
Share-based compensation 20,883 17,644
Adjusted EBITDA $ 186,671 $ 115,420
The following table reconciles reported net income to
adjusted EBITDA. (Unaudited, amounts in thousands)