Cowen & Co. Health Care Conference

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Cowen & Co Health Care Conference March 6, 2013

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Cowen & Co. Health Care Conference

Transcript of Cowen & Co. Health Care Conference

Page 1: Cowen & Co. Health Care Conference

Cowen & Co Health Care Conference

March 6, 2013

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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 January 2013. Trademarks referenced herein are the property of their respective owners. ©2013 Impax Laboratories, Inc. All Rights Reserved. 2

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Significant improvements in the past two years – Quality first culture

– Management and organization structure changes

– Increased the headcount in quality and quality-related areas

– 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

– Taiwan inspected in July 2012 with no Form 483 observations

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Committed to Improving Our Operations Moving in the Right Direction…

Note: Data as of March 4, 2013.

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Making significant progress in Quality Improvement Program – Pre-identified some of the recent Form 483 observations

– Working aggressively to complete key aspects of the Quality Improvement Program

– Ongoing work to identify and address improvement projects

– Work is in addition to responding to the Form 483 observations

Have the financial means to: – Properly fund resources needed to resolve Form 483 observations

– Improve our operations globally

– Create a top notch manufacturing and quality operation

Promptly resolving the Warning Letter is our highest priority 4

Committed to Improving Our Operations …But Have More Work to do

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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 January 2013.

Positioned for Future Growth

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Two Platforms for Growth

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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 75 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 strong product pipeline Developing strong IP positions

Note: Data as of February 8, 2013.

Generic Platform Branded Platform

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Strategy to Create Long Term Growth

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Revenue Growth Opportunities

Diversifying Generic Business product mix

Focusing on building a strong 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 $299MM cash/cash equivalents and no debt

Note: Data as of December 31, 2012

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Strategic Initiatives for Generic 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 Both Solid Oral &

Alternative Dosage Forms (ADF)

Strategic Partnerships Primarily in ADFs

Strategic M & A Primarily in ADFs

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2008 2009 2010 2011 2012

4 4

20

1 1 5

5 9 Currently Marketed

Pending at FDAUnder Development

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34

Growing Alternative Dosage Form Portfolio ADF Products Offer Potential Market Sustainability

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Cumulative Growth of Partnership and Internal/Hybrid ADF Projects

Note: Date as of February 8, 2013. All product sales data included herein are derived from data published by IMS for the 12 months ended January 2013.

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0

25 Future Opportunities are ADFs A number of them still FTF/FTM opportunities

$4B Current U.S. Brand/Generic Sales

1

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Pending at FDA Under Development

19

26

5

5

20

Other Solid Oral Controlled-Release Solid Oral Alternative Dosage Form

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Diversifying Generic Product Pipeline

75 Future Opportunities Pending at FDA or Under Development $25B Current U.S. Brand/Generic Sales

50

25

25 Total ADF 33% of Pipeline

31 Total C-R SO 42% of Pipeline

19 Total Other SO 25% of Pipeline

Note: Date as of February 8, 2013. All product sales data included herein are derived from data published by IMS for the 12 months ended January 2013.

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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)

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Building a Brand Product Pipeline

Migraine

Parkinson’s Disease (carbidopa-levodopa)

Epilepsy

PHASE I OR POC PHASE II PHASE III REGISTRATION APPROVED PROJECT

Zomig®

RYTARYTM (a)

IPX218

IPX203

IPX231

IPX232

IPX…

Parkinson’s Disease

Parkinson’s Disease

Migraine

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(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

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RYTARYTM (IPX066): Preparing for Launch Carbidopa and Levodopa Extended-Release Capsule

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DEC. 2011

FEB. 2012

THROUGHOUT 2012 - 2013

NDA Filed

Pre-launch planning Building sales &

marketing team Conducting pre-launch

activities

FDA Acceptance

of NDA Filing

PDUFA Date - Received Complete Response

Letter

JAN. 21, 2013(a)

1st Patent Granted Aug. 2006 Expires May 2022

2nd Patent Granted Dec. 2008 Expires Dec. 2028

PATENT INFORMATION

(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 RYTARYTM 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.

Source: National Parkinson’s Foundation. Parkinson’s Disease Overview

More than one million people in the U.S., with 50,000-60,000 new cases diagnosed each year in the U.S. alone

RYTARY™ (IPX066) for the Symptomatic Treatment of Parkinson’s Disease

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Investments Drove Revenue Growth

2004 2005 2006 2007 2008 2009 2010 2011 2012

$91 $112 $135

$274 $210

$358

$683

$513 $573

Created Significant Resources to Fund Business Development and M&A Financial Flexibility = $299MM in cash/cash equivalents and NO DEBT

Note: $299MM cash and cash equivalents as of December 31, 2012. 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. 14

$ millions

26% 8-Year CAGR

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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 October 2012.

Positioned for Future Growth