Cowen and Company 34 th Annual Health Care Conference

Transcription

1 Cowen and Company 34 th Annual Health Care Conference March 3, 2014

2 Forward-Looking Statement Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: To the extent any statements made in this news release 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 impact of consolidation of the Company s customer base; the impact of competition; the substantial portion of our total revenues derived from sales of a limited number of products; 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; 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; 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 our industry, business, results of operations and financial condition; 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 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 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; 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. Note: All product sales data included herein are derived from data published by IMS for the 12 months ended December Trademarks referenced herein are the property of their respective owners Impax Laboratories, Inc. All Rights Reserved. 2

3 Leveraging Our Dual Business Model Generic Brand Shared Services 3

4 Investments Drove Revenue Growth Created Significant Resources to Fund Business Development and M&A 21% 7-Year CAGR $683 $513 $573 $512 $135 $274 $210 $ Hayward Warning Letter (1) 4 $ millions Annual revenues as reported (GAAP) except: 2010 which excludes $196MM due to a change in revenue recognition under the Teva Agreement which excludes $9MM due to a change in revenue recognition under an OTC Partner Agreement. (1) New product approvals haven t been received since May 2011 following receipt of a Warning Letter at Hayward facility.

5 And High Margin Opportunities Last Twelve Months Adjusted Gross Margin 59% 55% 54% 51% 50% 48% 47% 40% 37% TEVA AKRX IPXL MYL ACT LCI MNK PRGO HSP 5 Source: Most recent company quarterly earnings releases as of February 28, 2014.

6 Strategy to Create Long Term Growth REVENUE GROWTH Internal High Value R&D Opportunities OPPORTUNITIES M&A Supported by Financial Resources and Strong Balance Sheet External High Value R&D Through Partnerships Business Development 6

7 Business Development/M&A Objectives Generics specific High value Solid Oral Dose or Alternative Dosage Form product opportunities Companies with R&D capability (US or ex-us) Brand specific Products for neurologists or psychiatrists Neurology or psychiatry focused pipeline product(s) with near-term launch Orphan drugs, CNS preferred Corporate Existing/future US sales opportunities Near-term growth potential Near-term accretive Tax efficiencies Manageable execution risk 7

8 Building a Sustainable Quality Program Fostering a Quality First Culture Change Management Validations KEY QUALITY SYSTEMS Training Investigations Documentation 8

9 Committed to Improving Our Operations Analytical R&D Computer Systems Validation Engineering Remediation & Quality Improvement Program 2011 to 2013 = $41MM 2014E = $25MM to $30MM (1) Information Technology Manufacturing Quality Assurance Quality Control Regulatory Compliance Tech Services 9 (1) Fourth Quarter and Full Year 2013 Earnings Release Estimated spend as of February 20, 2014 Training

10 Successfully Launching New Products Estimated Mid-April 2014 Authorized Generic RENVELA Tablets (First-to-File) 2013 $97 Million Revenue Contribution Oxymorphone Hydrochloride ER Tablets (First-to-File) Authorized Generic Zomig Tablets Authorized Generic Zomig Orally Disintegrating Tablets Authorized Generic Trilipix Delayed Release Capsules Generic Solaraze Gel 3% (First-to-File) 10 Source: Impax K

11 Diversifying Generic Product Pipeline 81 Future Opportunities Pending at FDA or Under Development $26B Current U.S. Brand/Generic Sales Pending at FDA Under Development 19 Alternative Dosage 23% of Pipeline 37 Controlled-Release Solid Oral Dosage 46% of Pipeline 25 Other Solid Oral Dosage 31% of Pipeline 11 Note: Date as of February All product sales data included herein are derived from data published by IMS for the 12 months ended December 2013.

12 Building a Branded Product Pipeline PROJECT INDICATION PHASE I or POC PHASE II PHASE III REGISTRATION APPROVED Zomig Migraine Zolmitriptan RYTARY TM /IPX066 (a) ELADUR / IPX239 IPX Parkinson s Disease Postherpetic Neuralgia (PHN) Several Early Stage Projects Bupivacaine Carbidopa-Levodopa (CD-LD) 12 (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.

13 Growing Zomig Nasal Spray Share Building relationships with neurologists since July 2006 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 Share, National 80% 70% 60% 50% 40% 30% 20% 10% Since Impax Promotion April 12 to Jan 14 Sumatriptan -8% decrease Zomig +25% increase Imitrex +6% increase 0% Jan-14 Dec-13 Nov-13 Oct-13 Sep-13 Aug-13 Jul-13 Jun-13 May-13 Apr-13 Mar-13 Feb-13 Jan-13 Dec-12 Nov-12 Oct-12 Sep-12 Aug-12 Jul-12 Jun-12 May-12 Apr-12 Mar-12 Feb Source: IMS NPA

14 2014 Objectives Complete implementation of a best in class Quality Improvement Program in line with our Quality First Culture Successfully commercialize potential new generic product launches (a) Planning launch of authorized generic RENVELA tablets in mid-april RYTARY TM NDA resubmission File European Market Authorization Application by 2H 2014 Out-license ex-us Continue to grow internal pipelines Generic - submit new ANDAs Brand - further development of existing products 14 (a) Majority of potential generic product launches will likely require resolution of Warning Letter in Hayward. Note: As of February 20, Contains forward looking statements; actual results may vary materially.

15 Positioned For Future Growth Established Core Competencies Targeting Sustainable Generic Markets Targeting Specialized Brand Markets Strong and Flexible Financial Profile 15

16 GAAP to Non-GAAP Reconciliation Impax Laboratories (Unaudited, amounts in thousands) Year Ended December 31, 2013 Cost of revenues $312,202 Adjusted to deduct: Amortization and acquisition-related costs 16,374 Hayward facility remediation costs 25,931 Employee severance 2,411 Intangible asset impairment charge 13,156 Provision for inventory reserve 18,053 Adjusted cost of revenues $236,277 Total revenues $511,502 Adjusted cost of revenues $236,277 Adjusted gross profit $275,225 Adjusted gross margin 53.8% 16