Bank of America Merrill Lynch Health Care Conferene May 16 2013
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Transcript of Bank of America Merrill Lynch Health Care Conferene May 16 2013
Bank of America Merrill LynchHealth Care Conference
May 16, 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 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, 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. 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.
Note: All product sales data included herein are derived from data published by IMS for the 12 months ended February 2013. Trademarks referenced herein are the property of their respective owners.©2013 Impax Laboratories, Inc. All Rights Reserved.2
• Submitted responses to recent Form 483 to the FDA on March 21, 2013
• Requested a meeting with San Francisco District Office to ensure plans and actions are in alignment with the FDA’s expectations
Significant improvements in the past two years
– Quality first culture
– Management and organization structure changes
– Initiated an internal Quality Improvement Program
• Identify necessary enhancements to Quality systems beyond Warning Letter and Form 483 observations
– Implemented corrective actions and enhancements across all sites
3
Committed to Improving Our Operations Moving in the Right Direction
Note: Data as of May 1, 2013.
4
Generic pipeline targeting $25B U.S. sales Brand pipeline focused on Central Nervous System (CNS) Solid platform on which to build long-term growth
Targeting Sustainable Generic and Specialized
Brand Markets
Track record of complex formulation and development Established drug delivery capabilities Hatch-Waxman expertise and Paragraph IV successes
Established Core
Competencies
Diversifying Generic business product mix Building a Branded business pipeline Financial resources and flexibility to support growth
Strong and Flexible
Financial Profile
Note: All brand/generic product sales data included herein are derived from data published by IMS for the 12 months ended February 2013.
Positioned for Future Growth
Two Platforms for Growth
5
Unique targeted ANDAs
• Solid Oral Dosage (SOD)
• Alternative Dosage Form (ADF)
First-to-File/First-to-Market emphasis
Focusing on sustainable products
Partnerships/M&A primarily on ADFs
74 products pending at FDA or under development
Creating highly valued CNS products
RYTARYTM – NDA pending approval
Commercializing Zomig® in the U.S.
Partnerships/M&A areas
• Neurology
• Psychiatry
Building a product pipeline
Developing strong IP positions
Note: Data as of May 1, 2013.
Generic Platform Branded Platform
Strategy to Create Long Term Growth
6
Revenue Growth Opportunities
Diversifying Generic Business product mix
Focusing on building a Brand pipeline
Executing business development and M&A
activities
Operational Improvements
Focusing on improving quality and compliance
Right-sizing manufacturing costs and capacity
Enhancing management team across the company
Supported by financial resources and strong balance sheet: approximately $400MM cash/cash equivalents and no debt
Note: Approximately $400MM in cash and cash equivalents. As of March 31, 2013, cash and cash equivalents were $349MM, and excluded a $102MM pre-tax (approximately $65MM after-tax) receipt from Endo Health Solutions received in April 2013.
Strategic Initiatives for Generic Growth
Organic Growth through SOD and
ADF Forms
Partnership Mainly in ADF
M&A Mainly in ADF
7
Focusing on…
Organic Growth
Both Solid Oral &
Alternative Dosage
Forms (ADF)
Strategic Partnerships
Primarily
in ADFs
Strategic M & A
Primarily
in ADFs
2008 2009 2010 2011 2012
1
1 5
5
4 4
20
9Currently MarketedPending at FDAUnder Development
9
34
Growing Alternative Dosage Form Portfolio ADF Products Offer Potential Market Sustainability
8
Cumulative Growth of Partnership and Internal/Hybrid ADF Projects
Note: Date as of May 1, 2013. All product sales data included herein are derived from data published by IMS for the 12 months ended February 2013.
5
0
25 Future Opportunities are ADFsA number of them still FTF/FTM opportunities
$4B Current U.S. Brand/Generic Sales
1
Pending at FDA Under Development
17
27
5
5
20
Other Solid Oral Controlled-Release Solid Oral Alternative Dosage Form
9
Diversifying Generic Product Pipeline
74 Future Opportunities Pending at FDA or Under Development$25B Current U.S. Brand/Generic Sales
49
25
25 Total ADF 34% of Pipeline
32 Total C-R SO 43% of Pipeline
17 Total Other SO 23% of Pipeline
Note: Date as of May 1, 2013. All product sales data included herein are derived from data published by IMS for the 12 months ended February 2013.
Strategic Initiatives for Brand Growth
Organic Growth through SOD and
ADF Forms
Partnership Mainly in ADF
M&A Mainly in ADF
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Focusing on…
Organic Growth
Primarily in
Neurology Area
Partnerships
Neurology &
Psychiatry Areas
M & A
Neurology &
Psychiatry Areas(Products/Companies)
Building a Brand Product Pipeline
Migraine
Parkinson’s Disease (carbidopa-levodopa)
Epilepsy
PHASE I OR POC PHASE II PHASE III REGISTRATION APPROVEDPROJECT
Zomig®
RYTARYTM (a)
IPX218
IPX203
IPX231
IPX232
IPX…
Parkinson’s Disease
Parkinson’s Disease
Migraine
11
(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.
Exploratory Projects
Investments Drove Revenue Growth
2006 2007 2008 2009 2010 2011 2012
$135
$274 $210
$358
$683
$513 $573
Created Significant Resources to Fund Business Development and M&A
Financial Flexibility = Approximately $400MM in cash/cash equivalents and NO DEBT
Note: Approximately $400MM cash and cash equivalents . As of March 31, 2013, cash and cash equivalents were $349MM, and excluded a $102MM pre-tax (approximately $65MM after-tax) receipt from Endo Health Solutions received in April 2013.Annual revenues as reported (GAAP) except: 2010 which excludes $196MM due to a change in revenue recognition under the Teva Agreement.2012 which excludes $9MM due to a change in revenue recognition under the OTC Partner Agreement.
12
$ millions
27% 6-Year CAGR
13
Generic pipeline targeting $25B U.S. sales Brand pipeline focused on Central Nervous System (CNS) Solid platform on which to build long-term growth
Targeting Sustainable Generic and Specialized
Brand Markets
Track record of complex formulation and development Established drug delivery capabilities Hatch-Waxman expertise and Paragraph IV successes
Established Core
Competencies
Diversifying Generic business product mix Building a Branded business pipeline Financial resources and flexibility to support growth
Strong and Flexible
Financial Profile
Note: All brand/generic product sales data included herein are derived from data published by Wolters Kluwer Health for the 12 months ended February 2013.
Positioned for Future Growth