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UBS Global Healthcare
Conference
May 19, 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 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.
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Who We Are
Impax Generics
Targeting complex, high-value,
solid oral and alternative dosage
form ANDAs
Impax Specialty Pharma
Developing products for unmet
needs in the treatment of Central
Nervous System disorders and
other select specialty segments
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Key Areas of Focus
Quality
Maximize
Dual
Platform
Optimize
R&D
Business
Development
Acceleration
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Impax Specialty Pharma
Key Branded Products
Product
Therapeutic Area
Parkinson’s Disease
Migraine
Anthelmintic
(albendazole) tablets
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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
Market Dynamics
• 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
Sales/TRx by Category
Parkinson’s Disease Sales and TRx
MAT Nov. 2014
Sales
$700MM
$296
2.8
0.2
$149
$67
5.1
$180
Sales
CD/LD*
Dopamine Agonists
Sources: IMS; Decision Resources
TRx
8.7MM
0.6
TRx
COMT-I
MAO-I
$ millions; TRx millions; Source: IMS National Prescription Audit (NPA
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Payer Split
95% of CD/LD TRx’s are in Commercial and Part D
Method of Payment (Nov ‘12 – Oct ‘13):
Carbidopa/Levodopa Product Group1
Medicaid
2%
Commercial
43%
Cash
4%
Medicare
Part D
52%
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%)
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RYTARY U.S. Market Assumptions and Growth
2015 Critical U.S. Market Assumptions






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*
Projected U.S. Revenue Growth*
$275MM to $350MM
2015E
2016E
2017E
2018E
*Projected based on current forecasts as of December 31, 2014.
2019E
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RYTARY Key Objectives
1
Drive targeted HCP awareness and adoption
2
Ensure successful trial and retention
3
Ease barriers to patient access
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RYTARY Awareness and Adoption
Drive awareness and adoption
Ensure successful trial and retention
Ease patient barriers to access
Establish RYTARY as the new CD/LD of choice
to treat “off” time
• 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
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Dose Conversion and Samples
Drive awareness and adoption
Ensure successful trial and retention
Ease patient barriers to access
Educate on RYTARY dosing and provide samples to help
HCP’s with patient initiation
• 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
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Ease Patient Access Barriers
Drive awareness and adoption
Ensure successful trial and retention
Ease patient barrier to access
Provide patient support programs
• 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
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RYTARY TRx Weekly Growth Since Launch
902
813
684
513
717
532
483
401
309
330
222
57
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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
Diversified Generic Commercialized Portfolio
47 Currently Marketed Products
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Alternative
Dosage
Form
10
ControlledRelease
SOD
26
Other SOD
Source: Data as of May 1, 2015; SOD = Solid Oral Dosage Form
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Multiple Opportunities for Growth
ANDAs Pending at FDA
Development
Current U.S. Brand/Generic market $9B sales
Current U.S. Brand/Generic market $10B sales
30% Potential FTF or FTM
48% Potential FTF or FTM
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12
15
3
7
14
Internal
Other SOD
10
10
9
4
3
2
1
External
Internal
External
Controlled-Release SOD
Alternative Dosage Form
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
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Potential Generic Launches in 2015
Current U.S. Brand/Generic market $1.6B sales
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YTD Product Launches
6
4
2*
Lamotrigine ODT – FTF
2
Azelastine Nasal
1
Olopatadine Nasal
Oxymorphone IR tablet
3
2
Internal
Launched
Metaxalone 400mg IR tablet
External Partners
Pending Approval
Approved/Re-introduction
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
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Diversifying Revenue Base
Impax
Impax + CorePharma*
2014 Revenues
2015 Estimated Revenues
Brand
8%
Brand
20%-25%
Generic
92%
Generic
75%-80%
*CorePharma, LLC, Amedra Pharmaceuticals LLC, Lineage Therapeutics Inc. and Trail Services, Inc. (collectively CorePharma)
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Well Positioned for Growth
Targeting Sustainable Generic Markets
Targeting Sustainable Branded Specialized Markets
Strong and Flexible Financial Profile
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