impax acquires tower holdings inc and lineage therapeutics inc oct 9 2014

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Impax to Acquire Tower Holdings, Inc. and Lineage Therapeutics Inc. October 9, 2014

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Impax acquires tower holdings inc and lineage therapeutics inc oct 9 2014

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Page 1: Impax acquires tower holdings inc and lineage therapeutics inc oct 9 2014

Impax to Acquire Tower Holdings, Inc. and Lineage Therapeutics Inc.

October 9, 2014

Page 2: Impax acquires tower holdings inc and lineage therapeutics inc oct 9 2014

Impax Cautionary Statement Regarding Forward Looking Statements and Use of Non-GAAP Financial Measures 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 parties’ ability to meet expectations regarding the timing and completion of the transaction with the Corepharma companies; the parties’ ability to consummate the transaction; the conditions to the completion of the transaction, including the receipt of the regulatory approvals required for the transaction not being obtained on the terms expected or on the anticipated schedule; the integration of the acquired business by the Company being more difficult, time-consuming or costly than expected; operating costs, customer loss and business disruption (including, without limitation, difficulties in maintaining relationships with employees, customers, clients or suppliers) being greater than expected following the transaction; the retention of certain key employees of the acquired business being difficult; the Company’s and the acquired business’s expected or targeted future financial and operating performance and results; the combined company’s capacity to bring new products to market; and the possibility that Company may be unable to achieve expected synergies and operating efficiencies in connection with the transaction within the expected time-frames or at all and to successfully integrate the acquired business; 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. Trademarks referenced herein are the property of their respective owners. ©2014 Impax Laboratories, Inc. All Rights Reserved.

Use of Non-GAAP Financial Measures

This presentation contains forward-looking EBITDA, which is a non-GAAP financial measure. EBITDA is adjusted to exclude, among other things, the impact of interest income and expense, depreciation and amortization expense, and income tax expense or benefit. These items are excluded from EBITDA because they are generally outside the normal operations of a company. There are limitations in using non-GAAP financial measures, as they are not prepared in accordance with generally accepted accounting principles, and may be different than non-GAAP financial measures used by other companies. The non-GAAP financial measures included in this press release are not meant to be considered superior to or a substitute for results of operations prepared in accordance with GAAP. It is not feasible to provide reconciliation to the most comparable projected U.S. GAAP measure because the excluded items are difficult to predict and estimate and are primarily dependent on future events.

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Page 3: Impax acquires tower holdings inc and lineage therapeutics inc oct 9 2014

• Founded in 1998, CorePharma develops, manufactures and markets high-quality, targeted, generic prescription pharmaceuticals across a variety of dosage forms and therapeutic categories

• Six facilities in Middlesex, New Jersey

• Amedra Pharmaceuticals focuses on offering high value branded prescription products in the United States

• Lineage Therapeutics focuses on offering generic products in the United States

Acquired Companies

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Tower Holdings subsidiary

Tower Holdings subsidiary

Page 4: Impax acquires tower holdings inc and lineage therapeutics inc oct 9 2014

Acquisition Adds Growth and Provides Strategic and Financial Benefits

COMPELLING STRATEGIC BENEFITS

Provides portfolio of growing, high-margin, complex branded and generic products

4 branded products: Albenza®: Niche Anthelmintic Daraprim®: Antiparasitic Dexedrine® ER: ADHD & Narcolepsy Adrenaclick®: Anaphylaxis

3 high value AG’s Epinephrine auto-injector Metaxalone Dextroamphetamine ER

5 complementary generic products

Generic pipeline with near-term opportunities

Diversifies and expands manufacturing and supply chain infrastructure

Accelerates Strategy – Focus on Maximizing Brand and Generic Platform, Optimizing R&D and Business Development

COMPELLING FINANCIAL BENEFITS

Immediately accretive to earnings per diluted share by approximately $0.90 in 2015

Assumes transaction closes within next six months

Diversifies and enlarges revenue and earnings base Approximately $215MM-$225MM in 2014E

revenues Approximately $80MM-$85MM in 2014E EBITDA

> $10MM+ of synergy opportunity Reduced SG&A R&D optimization of combined portfolio

Gross margins comparable to current Impax margin profile

Continued balance sheet flexibility

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AG = Authorized Generic

Page 5: Impax acquires tower holdings inc and lineage therapeutics inc oct 9 2014

Transaction Overview

Purchase Consideration

$700 million in cash, subject to customary closing conditions

Financing ~$435 million of committed financing

Expected loan terms based on current market conditions - 6 year maturity, Libor +450 bps, 1% Libor floor

~$265 million funded through Impax cash

Pro forma leverage allows flexibility for additional mergers and acquisitions and business development

Allows Flexibility for Additional Growth Opportunities

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Page 6: Impax acquires tower holdings inc and lineage therapeutics inc oct 9 2014

Business Overview Fully integrated pharmaceutical business focused

on complex branded and generic products

12 currently marketed products

Product pipeline includes 51 ANDAs in various stages of development representing current U.S. brand and generic sales of $10.7(1) billion, which includes 16 pending approval or re-launch

DEA and FDA licensed campus in Middlesex, NJ with additional offices in Horsham, PA

Experienced team with over 280 employees, 30 focused on R&D

Proven capabilities in controlled substances, extended-release products, supported by significant regulatory expertise

Marketed Products Therapeutic Area

Branded Division Products Anaphylaxis

Anthelmintic

Protozoal infections

ADHD; narcolepsy

Generic Division Products Amphetamine ADHD

Dextroamphetamine ER (AG) ADHD; narcolepsy

Dextroamphetamine IR ADHD; narcolepsy

Epinephrine auto-injector (AG)(2) Anaphylaxis

Hydrocortisone Adrenocortical steroid

Metaxalone (AG) Muscle relaxant

Methenamine Hippurate Urinary tract infections

Methylphenidate IR ADHD

(1) Source: IMS National Sales Perspective Audit last 12 months ended August 2014 (2) Authorized Generic to Adrenaclick®

(3) Source: Tower Holdings, Inc. internal estimates AG = Authorized Generic

35% 65%

Branded Generic

Approximate 2014E Revenues by Division(3)

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Page 7: Impax acquires tower holdings inc and lineage therapeutics inc oct 9 2014

Albenza® Franchise: Leading Treatment with Significant Upside Opportunities Albenza (albendazole) is indicated for the

treatment of invasive tapeworm infections The leading treatment for this indication Established safety profile Strong managed care coverage

Long-term opportunity via life cycle management strategies

Addition of this new therapeutic area allows Impax to more efficiently utilize its brand commercial infrastructure and provides upside growth potential

Niche Product with Strong Growth, Attractive Margins, with Lifecycle Management Strategies

Source: Sales figures IMS National Prescription Audit; Prescription numbers in thousands.

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26,133

75,384

139,656

89,704

2011 2012 2013 (Jan- Aug) 2014

Albenza Annual Prescription Volume

Page 8: Impax acquires tower holdings inc and lineage therapeutics inc oct 9 2014

Epinephrine Auto-Injector: High Growth Potential in an Attractive Market Large and growing market driven by

increase in prevalence of people suffering from allergies

Launched two epinephrine auto-injector products in 2013: Branded version (Adrenaclick®) Authorized Generic to Adrenaclick®

Competitively priced products

Opportunity for continued growth 1,416 1,551 1,656 1,918 2,187

3,421 3,772 4,101 5,036

5,783

2009 2010 2011 2012 2013

US Epinephrine Auto-injector sales(1)

0.15MG 0.30MG

4,837 5,757

5,323

6,953 7,971

(‘000s of auto-injectors)

(1) Source: Sales figure IMS National Sales Perspective Audit

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Page 9: Impax acquires tower holdings inc and lineage therapeutics inc oct 9 2014

Generic Pipeline with Near-Term Opportunities

Current pipeline of 51 products at various stages of development

Complementary focus on high-value formulations including extended-release and DEA-regulated controlled substances

Provides a pipeline with market dynamics that drive growth De-risked pipeline due to several already

approved ANDA re-launches Pipeline products are Paragraph I-III and

high-value Paragraph IV opportunities

Pipeline products represent $10.7(1) billion in U.S brand and generic sales

Products supplied through CorePharma facility or third parties

(1) Source: Sales figure IMS National Sales Perspective Audit last 12 months ended August 2014

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5

11

35

Approved Not YetLaunched

Pending Approval Additional Products InVarious Stages of

Development

Product Pipeline(1)

Number of Products ($ billions)

$0.6 $0.8

$9.3

Page 10: Impax acquires tower holdings inc and lineage therapeutics inc oct 9 2014

Diversifies and Expands Manufacturing and Supply Chain Capabilities

Fully integrated capabilities across R&D, manufacturing and regulatory functions

Successful pre-approval inspections in February and August 2014

Successfully implemented a Quality and Compliance Improvement Program

63,200 sq. ft. manufacturing/warehousing facility across two buildings

DEA licensed and FDA approved site

Extended-release and controlled-release experience

Capabilities include:

- Low-shear and high-shear granulations

- Direct compression blends

- Functional and non-functional aqueous film coatings

109,000 sq. ft. Campus in Middlesex, New Jersey

Manufacturing

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Page 11: Impax acquires tower holdings inc and lineage therapeutics inc oct 9 2014

DEA licensed and FDA approved manufacturing facility Successful implementation of a Quality Improvement Program with

proven results

Lead Brand in a new therapeutic area High value Generic product line

Focus on late stage & life cycle management Brand projects Significant near-term Generic opportunities Opportunity for optimization of combined R&D portfolio

Strategic M&A transaction intended to enhance Shareholder value Balance sheet remains flexible for additional opportunities

Acquisition Delivers in Our Primary Areas of Focus

Focus on Quality

Maximize Dual Platform

Optimize R&D

Business Development Acceleration

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Page 12: Impax acquires tower holdings inc and lineage therapeutics inc oct 9 2014

Adds Immediate and Future Value to Impax

Portfolio of growing, high-margin, complex branded and generic products

Leading franchise in a new niche brand therapeutic area

Diversifies and expands manufacturing and supply chain capabilities with FDA licensed manufacturing facility

Experienced employee base

Immediately accretive to earnings

Moves Impax to a more efficient capital structure

Strong financial profile with future upside potential from brand and generic product pipeline

Synergy opportunities primarily through R&D optimization of combined portfolio and SG&A

Continued balance sheet flexibility for future M&A and business development

Integration of Quality Initiatives and culture across manufacturing facilities

Immediate Future

Strategic Acquisition Enhances Portfolio and Drives Growth

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Page 13: Impax acquires tower holdings inc and lineage therapeutics inc oct 9 2014

Next Steps

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Anticipated closing within the next six months

Customary closing conditions and regulatory approvals, including Hart-Scott-Rodino review

Marketing and syndication of the committed debt financing