Credit Suisse Healthcare Conference

Transcription

1 Credit Suisse Healthcare Conference November 14, 2013

2 Safe Harbor Statement 2 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 forwardlooking 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. Forwardlooking 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 September Trademarks referenced herein are the property of their respective owners Impax Laboratories, Inc. All Rights Reserved.

3 Positioned for Future Growth Targeting Sustainable Generic and Specialized Brand Markets Generic pipeline targeting $26B U.S. sales Brand pipeline focused on Central Nervous System (CNS) Solid platform on which to build long-term growth Established Core Competencies Track record of complex formulation and development Established drug delivery capabilities Hatch-Waxman expertise and Paragraph IV successes Strong and Flexible Financial Profile Diversifying Generic business product mix Building a Branded business pipeline Financial resources and flexibility to support growth 3 Note: All brand/generic product sales data included herein are derived from data published by IMS for the 12 months ended September 2013.

4 Two Platforms for Growth Generic Platform Branded Platform 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 69 products pending at FDA or under development Creating highly valued CNS products RYTARY TM NDA pending approval Commercializing Zomig in the U.S. Partnerships/M&A areas Neurology Psychiatry Building a product pipeline Developing strong IP positions 4 Note: Data as of October 2013.

5 Strategy to Create Long Term Growth Revenue Growth Opportunities Diversifying Generic Business product mix Operational Improvements Focusing on improving quality and compliance Focusing on building a Brand pipeline Right-sizing manufacturing costs and capacity Executing business development and M&A activities Enhancing management team across the company Supported by financial resources and strong balance sheet: approximately $437MM cash/cash equivalents and no debt 5 Note: Data as of September 30, 2013,.

6 Committed to Improving Our Operations Quality first culture Management and organization structure changes Initiated an internal Quality Improvement Program (QIP) Working aggressively to complete key aspects of the QIP Third-party experts continue to assist us with: Review of our manufacturing and quality systems Enhancing our systems and standards Committed to resolving all observations and exceeding current Good Manufacturing Practice 6

7 Strategic Initiatives for Generic Growth Focusing on Organic Growth through SOD and ADF Forms Organic Growth Partnership Mainly in ADF Both Solid Oral & Alternative Dosage Forms (ADF) Strategic Partnerships Primarily in ADFs Strategic M & A M&A Mainly in ADF Primarily in ADFs 7

8 2013 Generic Product Launches 8 January Oxymorphone Hydrochloride ER tablets 5, 7.5, 10, 15, 20, 30 and 40 mg May Authorized generic Zomig tablets Authorized generic Zomig Orally Disintegrating Tablets 2.5 and 5 mg July Authorized generic Trilipix Delayed Release Capsules 45 and 135 mg Shortly Solaraze Gel 3%

9 Diversifying Currently Marketed Portfolio 47 Currently Marketed Products Alternative Dosage Form 19% 9 13 Controlled-Release Solid Oral 28% 25 Other Solid Oral 53% 9 Note: Data as of October 2013.

10 Diversifying Generic Product Pipeline 69 Future Opportunities Pending at FDA or Under Development $26B Current U.S. Brand/Generic Sales Pending at FDA Under Development 19 Total ADF 28% of Pipeline 32 Total C-R SO 46% of Pipeline 18 Total Other SO 26% of Pipeline 10 Note: Date as of October All product sales data included herein are derived from data published by IMS for the 12 months ended September 2013.

11 Strategic Initiatives for Brand Growth Focusing on Organic Growth through SOD and ADF Forms Organic Growth Partnership Mainly in ADF Primarily in Neurology Area Partnerships Neurology & Psychiatry Areas M & A M&A Mainly in ADF Neurology & Psychiatry Areas (Products/Companies) 11

12 Building a Brand Product Pipeline PROJECT Zomig RYTARYTM (a) IPX203 IPX231 IPX232 IPX PHASE I OR POC PHASE II PHASE III REGISTRATION APPROVED Migraine Parkinson s Disease (carbidopa-levodopa) Parkinson s Disease Parkinson s Disease Migraine Exploratory Projects (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 RYTARY TM, as analytical method validation and a portion of the stability data were generated at the Hayward facility. 12

13 RYTARY TM (IPX066): Carbidopa and Levodopa Extended-Release Capsule PATENT INFORMATION DEC FEB JAN. 21, 2013 (a) THROUGHOUT 2013 RYTARY (IPX066) for the Symptomatic Treatment of Parkinson s Disease 1st Patent Granted Aug Expires May nd Patent Granted Dec Expires Dec NDA Filed FDA Acceptance of NDA Filing PDUFA Date - Received Complete Response Letter Pre-launch planning More than one million people in the U.S., with 50,000-60,000 new cases diagnosed each year in the U.S. alone 13 (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 TM 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 RYTARY TM, 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

14 Continuing Our Commercial Success Building relationships with neurologists since July 2006 Licensed exclusive U.S. commercialization rights to Zomig Began commercializing Zomig in April 2012 o Tablet and ZMT patents expired May 2013 Continuing commercialization of Zomig Nasal Spray o Nasal Spray patent expires May 2021 Nasal Triptan Market Share, National 80% 70% 60% 50% 40% 30% 20% 10% 0% Oct-11 Nov-11 Dec-11 Jan-12 Feb-12 Mar-12 Apr-12 May-12 Jun-12 Jul-12 Aug-12 Sep-12 Oct-12 Nov-12 Dec-12 Jan-13 Feb-13 Mar-13 Apr-13 May-13 Jun-13 Jul-13 Aug-13 Sep-13 Since Impax Promotion April 12 to Sept. 13 Sumatriptan -5% decrease Zomig +17% increase Imitrex -7% decrease 14 Source: IMS NPA Weekly

15 Positioned for Future Growth Targeting Sustainable Generic and Specialized Brand Markets Generic pipeline targeting $26B U.S. sales Brand pipeline focused on Central Nervous System (CNS) Solid platform on which to build long-term growth Established Core Competencies Track record of complex formulation and development Established drug delivery capabilities Hatch-Waxman expertise and Paragraph IV successes Strong and Flexible Financial Profile Diversifying Generic business product mix Building a Branded business pipeline Financial resources and flexibility to support growth 15 Note: All brand/generic product sales data included herein are derived from data published by IMS for the 12 months ended September 2013.