2015-global-healthcare-conference v001-p5bfu6
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UBS Global Healthcare Conference May 19, 2015
Impax Cautionary Statement Regarding Forward Looking Statements
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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 substantial portion of the Company’s total revenues derived from sales of a limited number of products; 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 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; changes to FDA approval requirements ; 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 the Company’s industry, business, results of operations and financial condition; disruptions or failures in the Company’s information technology systems and network infrastructure caused by third party breaches or other events; 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 effect of certain provisions in the Company’s government contracts; 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 and investments; the integration of the acquired business of Tower Holdings, Inc. and Lineage Therapeutics Inc. 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 acquisition, 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 the acquisition within the expected time-frames or at all, 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. ©2015 Impax Laboratories, Inc. All Rights Reserved.
Who We Are
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Targeting complex, high-value, solid oral and alternative dosage
form ANDAs
Developing products for unmet
needs in the treatment of Central Nervous System disorders and other select specialty segments
Impax Generics
Impax Specialty Pharma
Key Areas of Focus
Quality Maximize
Dual Platform
Optimize R&D
Business Development Acceleration
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Impax Specialty Pharma
Product Therapeutic Area
Parkinson’s Disease
Migraine
Anthelmintic
Key Branded Products
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(albendazole) tablets
RYTARY for Treatment of Parkinson’s Disease • 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
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The Parkinson’s Disease Market
• 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 sustained LD concentrations
• 87% of Parkinson’s disease patients are taking CD-LD products
8 $ millions; TRx millions; Source: IMS National Prescription Audit (NPA
Market Dynamics Sales/TRx by Category
Sources: IMS; Decision Resources
Parkinson’s Disease Sales and TRx MAT Nov. 2014
$180
$67
$149
$296
Sales
CD/LD* COMT-IDopamine Agonists MAO-I
5.1
0.2
2.8
0.6
TRx
Sales $700MM
TRx 8.7MM
Payer Split
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Medicare Part D 52%
Commercial 43%
Medicaid 2%
Cash 4%
Method of Payment (Nov ‘12 – Oct ‘13): Carbidopa/Levodopa Product Group1
95% of CD/LD TRx’s are in Commercial and Part D
Source: IMS NPA TRx Payer Data (Nov ‘12 – Oct ‘13) 1CD/LD product group includes carbidopa/levodopa (98%), Parcopa (<1%), Sinemet (<1%), Sinemet CR (<1%), Stalevo (<1%)
RYTARY U.S. Market Assumptions and Growth
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77 sales representatives 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 Net price between $15 to $17 per day*
2015 Critical U.S. Market Assumptions
*Projected based on current forecasts as of December 31, 2014.
2015E 2016E 2017E 2018E 2019E
$275MM to $350MM
Projected U.S. Revenue Growth*
RYTARY Key Objectives
Drive targeted HCP awareness and adoption 1
Ensure successful trial and retention 2
Ease barriers to patient access 3
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RYTARY Awareness and Adoption
• Focus advertising and promotion towards Parkinson’s Disease experts
• Educate: “What is RYTARY”
• Discuss RYTARY clinical study results
• Communicate effectively to appropriate HCPs in promotion materials and speaker programs
Establish RYTARY as the new CD/LD of choice to treat “off” time
Drive awareness and adoption Ensure successful trial and retention Ease patient barriers to access
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Dose Conversion and Samples
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• Reinforce that RYTARY is an Extended Release CD/ LD
• Inform that the final daily dose of LD in RYTARY in clinical trials was approximately 2X compared with IR CD/LD
• Sample starting dosages
Educate on RYTARY dosing and provide samples to help
HCP’s with patient initiation
Drive awareness and adoption Ease patient barriers to access Ensure successful trial and retention
Ease Patient Access Barriers
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Ease patient barrier to access Ensure successful trial and retention Drive awareness and adoption
• Copay support program to assist in patient adoption (patients with commercial insurance)
• Place copay support program in patient materials and on website
• Part D financial assistance grants
• Patient Assistance Program
Provide patient support programs
RYTARY TRx Weekly Growth Since Launch
9 57
222
309 330 401
513 483 532
684 717
813
902
13-Feb 20-Feb 27-Feb 6-Mar 13-Mar 20-Mar 27-Mar 3-Apr 10-Apr 17-Apr 24-Apr 1-May 8-May
Sources: IMS
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Impax Generics
26 Other SOD
10 Controlled-
Release SOD
11 Alternative
Dosage Form
47 Currently Marketed Products
Diversified Generic Commercialized Portfolio
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Source: Data as of May 1, 2015; SOD = Solid Oral Dosage Form
Multiple Opportunities for Growth
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14
12
4
3 Internal External
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ANDAs Pending at FDA Development
Current U.S. Brand/Generic market $9B sales
2
10 9
3
1 Internal External
15
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Current U.S. Brand/Generic market $10B sales
48% Potential FTF or FTM
Source of sales data: IMS March 2015; Pipeline data as of May 1, 2015 FTF = First-to-File; FTM = First-to-Market; SOD = Solid Oral Dosage Form
30% Potential FTF or FTM
Other SOD Controlled-Release SOD Alternative Dosage Form
Potential Generic Launches in 2015
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2 3
2* 1
4 2
Internal External Partners
Launched Pending Approval Approved/Re-introduction
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Current U.S. Brand/Generic market $1.6B sales
Source of sales data: IMS March 2015; Data as of May 1, 2015 *Requires approval from Hayward facility currently under a Warning Letter. FTF = First-to-File
YTD Product Launches Lamotrigine ODT – FTF
Azelastine Nasal
Olopatadine Nasal
Oxymorphone IR tablet
Metaxalone 400mg IR tablet
Diversifying Revenue Base
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Impax
Generic 92%
Impax + CorePharma*
Brand 8%
Generic 75%-80%
Brand 20%-25%
2014 Revenues 2015 Estimated Revenues
*CorePharma, LLC, Amedra Pharmaceuticals LLC, Lineage Therapeutics Inc. and Trail Services, Inc. (collectively CorePharma)
Well Positioned for Growth
Targeting Sustainable Generic Markets
Targeting Sustainable Branded Specialized Markets
Strong and Flexible Financial Profile
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