Introduction to Impax Laboratories (Taiwan), Inc. 益邦製藥股份有限公司 June 2009.

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Presentation transcript:

Introduction to Impax Laboratories (Taiwan), Inc. 益邦製藥股份有限公司 June 2009

2 Table of Content Impax Laboratories (Taiwan), IncImpax Laboratories (Taiwan), Inc History and Milestones History and Milestones R&D and Manufacturing Facility R&D and Manufacturing Facility Phase 1 Facility Phase 1 Facility Impax Laboratories, Inc. (The Parent Company)Impax Laboratories, Inc. (The Parent Company) Introduction Introduction Dual Strategic Focus Dual Strategic Focus Impax Growth Strategy Impax Growth Strategy Five Years of Successful Growth Five Years of Successful Growth Our FutureOur Future Career OpportunitiesCareer Opportunities

Impax Laboratories (Taiwan), Inc.

4 History and Milestones Incorporated in Taiwan on June 2007 Incorporated in Taiwan on June 2007 Wholly owned by Impax Laboratories, Inc. (USA) Wholly owned by Impax Laboratories, Inc. (USA) Serve as a strategic R&D and manufacturing center for Impax U.S. and global pharmaceutical markets Serve as a strategic R&D and manufacturing center for Impax U.S. and global pharmaceutical markets Broke ground for Phase 1 construction of a new facility on 4Q2007 Broke ground for Phase 1 construction of a new facility on 4Q2007 Passed the first U.S. FDA inspection of manufacturing facility in June 2009 Passed the first U.S. FDA inspection of manufacturing facility in June 2009 Routine production scheduled to begin 1Q2010 Routine production scheduled to begin 1Q2010

5 R&D and Manufacturing Facility Located at Jhunan Science Park ( 竹南科學園區 ); about 100 Km south of Taipei or 20 Km south of Hsinchu Located at Jhunan Science Park ( 竹南科學園區 ); about 100 Km south of Taipei or 20 Km south of Hsinchu A two-phase construction & commission project A two-phase construction & commission project Phase 1 to be completed by 4Q2009Phase 1 to be completed by 4Q2009 Phase 2 planned for 2011 or 2012Phase 2 planned for 2011 or 2012 Exclusively for manufacturing of pharmaceutical solid oral dosage forms (tablets, capsules and granules) Exclusively for manufacturing of pharmaceutical solid oral dosage forms (tablets, capsules and granules) Designed to meet U.S. FDA, European EMEA and Taiwan DOH cGMP requirements Designed to meet U.S. FDA, European EMEA and Taiwan DOH cGMP requirements Site has room for future expansion (Phase 2) Site has room for future expansion (Phase 2)

6 Phase 1 Facility USD$25 million of initial investment on construction and equipment USD$25 million of initial investment on construction and equipment Approximately 100,000 ft 2 total space on a 50,000 ft 2 footprint Approximately 100,000 ft 2 total space on a 50,000 ft 2 footprint Separate pilot plant for R&D and small scale manufacturing Separate pilot plant for R&D and small scale manufacturing Large scale manufacturing suite – 600 million unit annual output capacity Large scale manufacturing suite – 600 million unit annual output capacity Underground parking Underground parking All production for export to the U.S. All production for export to the U.S.

7 Impax (Taiwan) Phase I Facility

Impax Laboratories, Inc. (The Parent Company)

9 Introduction Established in 1995 by Drs. Charlie Hsiao and Larry Hsu as Impax Pharmaceuticals, a privately held company. Established in 1995 by Drs. Charlie Hsiao and Larry Hsu as Impax Pharmaceuticals, a privately held company. Merged with Global Pharmaceuticals in 1999 (through a reverse acquisition) to form a new public company, Impax laboratories, Inc. Merged with Global Pharmaceuticals in 1999 (through a reverse acquisition) to form a new public company, Impax laboratories, Inc. Company shares traded on NASDAQ (symbol: IPXL) Company shares traded on NASDAQ (symbol: IPXL) Core competence in drug delivery and pharmaceutical dosage form development Core competence in drug delivery and pharmaceutical dosage form development Currently has 3 U.S. sites: Currently has 3 U.S. sites: Hayward (CA) – headquarter, R&D, manufacturing & marketingHayward (CA) – headquarter, R&D, manufacturing & marketing Philadelphia (PA) – packaging and distributionPhiladelphia (PA) – packaging and distribution Chalfont (PA) – finance, sales/marketing and distributionChalfont (PA) – finance, sales/marketing and distribution

10 Impax Laboratories Facilities Taiwan Hayward Philly Chalfont

11 Introduction (cont’d) Started as a generic company specialized in developing controlled-release dosage forms Started as a generic company specialized in developing controlled-release dosage forms More than 40 generic products on the market under “Global Pharmaceutical” label. More than 40 generic products on the market under “Global Pharmaceutical” label. Established brand Division, Impax Pharmaceutical, in 2006 and started brand products development program Established brand Division, Impax Pharmaceutical, in 2006 and started brand products development program

12 Generic Products Pending or Under Development PresentFuture - # of Products in Pipeline

13 Dual Strategic Focus Expanding CR and IR Pipeline Unique targeted ANDAs Unique targeted ANDAs First-to-file, First-to-market First-to-file, First-to-market Limited competition Limited competition Difficult to formulate and manufacture Difficult to formulate and manufacture 28 apps pending at FDA 28 apps pending at FDA 43 under development 43 under development CNS Products Improve on marketed products Improve on marketed products Develop strong IP positions Develop strong IP positions 505(b)(2) NDA candidates 505(b)(2) NDA candidates IPX056 in Phase III IPX056 in Phase III IPX066 approaching Phase III IPX066 approaching Phase III 4 in exploratory stage 4 in exploratory stage

14 Impax Growth Strategy (Generic) Internal R&D Unique Targeted High Margin ANDAs Product Development Partnerships Acquisition (Product or Company) Alternate Dosage Forms Global Market

15 Impax Growth Strategy (Brand) In-license (products) Acquisition (products or companies) Global market through partnership Internal R&D programs Specialty sales force Co- promotion

16 Five Years of Successful Growth As Reported ($ millions) CAGR Revenue$58.8$ % Gross Profit $15.0$ % Gross Profit Margin 25.5%56.2%-- EBITDA($9.8)$ Operating Income (loss) ($13.2)$3.9-- Cash$15.5$ Debt$9.9$ ANDA Approvals 95343% Number of Product SKU’s % Total R&D Experts % Total Employees %

Our Future

18 Our Future As Impax moving aggressive into the next 5-year growth phase with acquisition and global market in mind, Impax (Taiwan) will play a very significant role in this global strategy.

Career Opportunities

20 Position Openings Impax (Taiwan) currently has approximately 20 openings at various levels in the following areas: Impax (Taiwan) currently has approximately 20 openings at various levels in the following areas: ManufacturingManufacturing EngineeringEngineering Material ManagementMaterial Management Technical SupportTechnical Support Quality AssuranceQuality Assurance Quality ControlQuality Control Regulatory AffairsRegulatory Affairs

21 Contact Information Please send your inquiring with resume and position(s) interested to: Please send your inquiring with resume and position(s) interested to: Human Resources Department or, 益邦製藥股份有限公司 or, 益邦製藥股份有限公司 人事部 葉經理 苗栗縣竹南鎮科東三路一號