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2015-global-healthcare-conference v001-p5bfu6

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UBS Global Healthcare Conference May 19, 2015
Transcript
Page 1: 2015-global-healthcare-conference v001-p5bfu6

UBS Global Healthcare Conference May 19, 2015

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Impax Cautionary Statement Regarding Forward Looking Statements

2

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: 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 substantial portion of the Company’s total revenues derived from sales of a limited number of products; 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 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; changes to FDA approval requirements ; 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 the Company’s industry, business, results of operations and financial condition; disruptions or failures in the Company’s information technology systems and network infrastructure caused by third party breaches or other events; 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 effect of certain provisions in the Company’s government contracts; 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 and investments; the integration of the acquired business of Tower Holdings, Inc. and Lineage Therapeutics Inc. 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 acquisition, 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 the Company may be unable to achieve expected synergies and operating efficiencies in connection with the acquisition within the expected time-frames or at all, 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. ©2015 Impax Laboratories, Inc. All Rights Reserved.

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Who We Are

3

Targeting complex, high-value, solid oral and alternative dosage

form ANDAs

Developing products for unmet

needs in the treatment of Central Nervous System disorders and other select specialty segments

Impax Generics

Impax Specialty Pharma

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Key Areas of Focus

Quality Maximize

Dual Platform

Optimize R&D

Business Development Acceleration

4

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Impax Specialty Pharma

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Product Therapeutic Area

Parkinson’s Disease

Migraine

Anthelmintic

Key Branded Products

6

(albendazole) tablets

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RYTARY for Treatment of Parkinson’s Disease • Approved by FDA January 7th 2015 • Three years Hatch-Waxman exclusivity • Four issued U.S. formulation patents

− One expires May 2022 − Three expire December 2028

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The Parkinson’s Disease Market

• Significant global market with strong future growth

• Carbidopa-Levodopa (CD-LD) is the primary therapy for Parkinson’s disease

• Significant unmet need for improved CD-LD product that produces relatively sustained LD concentrations

• 87% of Parkinson’s disease patients are taking CD-LD products

8 $ millions; TRx millions; Source: IMS National Prescription Audit (NPA

Market Dynamics Sales/TRx by Category

Sources: IMS; Decision Resources

Parkinson’s Disease Sales and TRx MAT Nov. 2014

$180

$67

$149

$296

Sales

CD/LD* COMT-IDopamine Agonists MAO-I

5.1

0.2

2.8

0.6

TRx

Sales $700MM

TRx 8.7MM

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Payer Split

9

Medicare Part D 52%

Commercial 43%

Medicaid 2%

Cash 4%

Method of Payment (Nov ‘12 – Oct ‘13): Carbidopa/Levodopa Product Group1

95% of CD/LD TRx’s are in Commercial and Part D

Source: IMS NPA TRx Payer Data (Nov ‘12 – Oct ‘13) 1CD/LD product group includes carbidopa/levodopa (98%), Parcopa (<1%), Sinemet (<1%), Sinemet CR (<1%), Stalevo (<1%)

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RYTARY U.S. Market Assumptions and Growth

10

77 sales representatives Marketing costs of approximately $13 million 8,100 target physicians Primary focus is existing carbidopa-levodopa patients Tier 2 or tier 3 formulary positioning with managed care Net price between $15 to $17 per day*

2015 Critical U.S. Market Assumptions

*Projected based on current forecasts as of December 31, 2014.

2015E 2016E 2017E 2018E 2019E

$275MM to $350MM

Projected U.S. Revenue Growth*

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RYTARY Key Objectives

Drive targeted HCP awareness and adoption 1

Ensure successful trial and retention 2

Ease barriers to patient access 3

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RYTARY Awareness and Adoption

• Focus advertising and promotion towards Parkinson’s Disease experts

• Educate: “What is RYTARY”

• Discuss RYTARY clinical study results

• Communicate effectively to appropriate HCPs in promotion materials and speaker programs

Establish RYTARY as the new CD/LD of choice to treat “off” time

Drive awareness and adoption Ensure successful trial and retention Ease patient barriers to access

12

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Dose Conversion and Samples

13

• Reinforce that RYTARY is an Extended Release CD/ LD

• Inform that the final daily dose of LD in RYTARY in clinical trials was approximately 2X compared with IR CD/LD

• Sample starting dosages

Educate on RYTARY dosing and provide samples to help

HCP’s with patient initiation

Drive awareness and adoption Ease patient barriers to access Ensure successful trial and retention

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Ease Patient Access Barriers

14

Ease patient barrier to access Ensure successful trial and retention Drive awareness and adoption

• Copay support program to assist in patient adoption (patients with commercial insurance)

• Place copay support program in patient materials and on website

• Part D financial assistance grants

• Patient Assistance Program

Provide patient support programs

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RYTARY TRx Weekly Growth Since Launch

9 57

222

309 330 401

513 483 532

684 717

813

902

13-Feb 20-Feb 27-Feb 6-Mar 13-Mar 20-Mar 27-Mar 3-Apr 10-Apr 17-Apr 24-Apr 1-May 8-May

Sources: IMS

15

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Impax Generics

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26 Other SOD

10 Controlled-

Release SOD

11 Alternative

Dosage Form

47 Currently Marketed Products

Diversified Generic Commercialized Portfolio

17

Source: Data as of May 1, 2015; SOD = Solid Oral Dosage Form

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Multiple Opportunities for Growth

18

14

12

4

3 Internal External

26

7

ANDAs Pending at FDA Development

Current U.S. Brand/Generic market $9B sales

2

10 9

3

1 Internal External

15

10

Current U.S. Brand/Generic market $10B sales

48% Potential FTF or FTM

Source of sales data: IMS March 2015; Pipeline data as of May 1, 2015 FTF = First-to-File; FTM = First-to-Market; SOD = Solid Oral Dosage Form

30% Potential FTF or FTM

Other SOD Controlled-Release SOD Alternative Dosage Form

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Potential Generic Launches in 2015

19

2 3

2* 1

4 2

Internal External Partners

Launched Pending Approval Approved/Re-introduction

8

6

Current U.S. Brand/Generic market $1.6B sales

Source of sales data: IMS March 2015; Data as of May 1, 2015 *Requires approval from Hayward facility currently under a Warning Letter. FTF = First-to-File

YTD Product Launches Lamotrigine ODT – FTF

Azelastine Nasal

Olopatadine Nasal

Oxymorphone IR tablet

Metaxalone 400mg IR tablet

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Diversifying Revenue Base

20

Impax

Generic 92%

Impax + CorePharma*

Brand 8%

Generic 75%-80%

Brand 20%-25%

2014 Revenues 2015 Estimated Revenues

*CorePharma, LLC, Amedra Pharmaceuticals LLC, Lineage Therapeutics Inc. and Trail Services, Inc. (collectively CorePharma)

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Well Positioned for Growth

Targeting Sustainable Generic Markets

Targeting Sustainable Branded Specialized Markets

Strong and Flexible Financial Profile

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