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Credit Suisse Healthcare Conference November 14, 2013

Impax Laboratories Credit Suisse 2013 Healthcare Conference November 14, 2013

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Page 1: Impax Laboratories Credit Suisse 2013 Healthcare Conference November 14, 2013

Credit Suisse Healthcare Conference

November 14, 2013

Page 2: Impax Laboratories Credit Suisse 2013 Healthcare Conference November 14, 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 September 2013. Trademarks referenced herein are the property of their respective owners. ©2013 Impax Laboratories, Inc. All Rights Reserved. 2

Page 3: Impax Laboratories Credit Suisse 2013 Healthcare Conference November 14, 2013

3

Generic pipeline targeting $26B 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 September 2013.

Positioned for Future Growth

Page 4: Impax Laboratories Credit Suisse 2013 Healthcare Conference November 14, 2013

Two Platforms for Growth

4

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 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 October 2013.

Generic Platform Branded Platform

Page 5: Impax Laboratories Credit Suisse 2013 Healthcare Conference November 14, 2013

Strategy to Create Long Term Growth

5

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 $437MM cash/cash equivalents and no debt

Note: Data as of September 30, 2013,.

Page 6: Impax Laboratories Credit Suisse 2013 Healthcare Conference November 14, 2013

• 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

Committed to Improving Our Operations

Page 7: Impax Laboratories Credit Suisse 2013 Healthcare Conference November 14, 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

Page 8: Impax Laboratories Credit Suisse 2013 Healthcare Conference November 14, 2013

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%

Page 9: Impax Laboratories Credit Suisse 2013 Healthcare Conference November 14, 2013

Diversifying Currently Marketed Portfolio

9 13

25

9

Other Solid Oral 53%

Controlled-Release Solid Oral

28%

Alternative Dosage Form

19%

47 Currently Marketed Products

Note: Data as of October 2013.

Page 10: Impax Laboratories Credit Suisse 2013 Healthcare Conference November 14, 2013

Pending at FDA Under Development

16

22

10

4

15

2

10

Diversifying Generic Product Pipeline

69 Future Opportunities Pending at FDA or Under Development $26B Current U.S. Brand/Generic Sales

42

27

19 Total ADF 28% of Pipeline

32 Total C-R SO 46% of Pipeline

18 Total Other SO 26% of Pipeline

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

Page 11: Impax Laboratories Credit Suisse 2013 Healthcare Conference November 14, 2013

Strategic Initiatives for Brand Growth

Organic Growth through SOD and

ADF Forms

Partnership Mainly in ADF

M&A Mainly in ADF

11

Focusing on…

Organic Growth Primarily in

Neurology Area

Partnerships Neurology &

Psychiatry Areas

M & A Neurology &

Psychiatry Areas (Products/Companies)

Page 12: Impax Laboratories Credit Suisse 2013 Healthcare Conference November 14, 2013

Building a Brand Product Pipeline

Migraine

Parkinson’s Disease (carbidopa-levodopa)

PHASE I OR POC PHASE II PHASE III REGISTRATION APPROVED PROJECT

Zomig®

RYTARYTM (a)

IPX203

IPX231

IPX232

IPX…

Parkinson’s Disease

Parkinson’s Disease

Migraine

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 RYTARYTM, as analytical method validation and a portion of the stability data were generated at the Hayward facility.

Exploratory Projects

Page 13: Impax Laboratories Credit Suisse 2013 Healthcare Conference November 14, 2013

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

13

DEC. 2011

FEB. 2012

THROUGHOUT 2013

NDA Filed

Pre-launch planning

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

Page 14: Impax Laboratories Credit Suisse 2013 Healthcare Conference November 14, 2013

0%10%20%30%40%50%60%70%80%

Oct

-11

Nov

-11

Dec

-11

Jan-

12Fe

b-12

Mar

-12

Apr

-12

May

-12

Jun-

12Ju

l-12

Aug

-12

Sep

-12

Oct

-12

Nov

-12

Dec

-12

Jan-

13Fe

b-13

Mar

-13

Apr

-13

May

-13

Jun-

13Ju

l-13

Aug

-13

Sep

-13

Nasal Triptan Market Share, National Since Impax Promotion April ’12 to Sept. ‘13

Continuing Our Commercial Success

14

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

Source: IMS NPA Weekly

Sumatriptan -5% decrease

Zomig® +17% increase

Imitrex® -7% decrease

Page 15: Impax Laboratories Credit Suisse 2013 Healthcare Conference November 14, 2013

15

Generic pipeline targeting $26B 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 September 2013.

Positioned for Future Growth