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Page 1: Investor Presentation (NASDAQ: PTX) - Pernix | · PDF fileThe following presentation includes “f orward-looking statements ... OTC Monograph Cough-related IP ... FDA approval of

Investor Presentation(NASDAQ: PTX)

Page 2: Investor Presentation (NASDAQ: PTX) - Pernix | · PDF fileThe following presentation includes “f orward-looking statements ... OTC Monograph Cough-related IP ... FDA approval of

The following presentation includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. You should be aware that our actual results could differ materially from those contained in the forward looking statements, which are based on management’s current expectations and are subject to a number of risks and uncertainties, including, but not limited to, our failure to successfully commercialize our product candidates; costs and delays in the development and/or FDA approval of our product candidates, including as a result of the need to conduct additional studies, or the failure to obtain such approval of our products or product candidates; changes in regulatory standards or the regulatory environment with any of our product candidates; our inability to maintain or enter into, and the risks resulting from our dependence upon, collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any products, including our inability to protect our patents or proprietary rights and obtain necessary rights to third party patents and intellectual property to operate our business; our inability to operate our business without infringing the patents and proprietary rights of others; general economic conditions; the failure of any products to gain market acceptance; our inability to obtain any additional required financing; technological changes; changes in industry practice; and one-time events. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission. Such documents may be read free of charge on the company’s web site, www.pernixtx.com, or the SEC’s web site at www.sec.gov. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.

Pernix™ is a registered trademark of Pernix Therapeutics, LLC. Other trademarks referenced herein are the property of their respective owners. ©2010 Pernix Therapeutics Holdings, Inc.

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Safe Harbor Statement

Page 3: Investor Presentation (NASDAQ: PTX) - Pernix | · PDF fileThe following presentation includes “f orward-looking statements ... OTC Monograph Cough-related IP ... FDA approval of

Swift, Nimble, Agile Specialty Pharma Company

Completed acquisition of Somaxon in March 2013

Completed Cypress and Hawthorn Acquisition in December 2012

Highly-effective sales force that is able to adapt quickly to launch and promote existing and new products

Growth Drivers:

Generics: Macoven/Cypress

Branded: Pernix/Hawthorn

Silenor re-launch

Launch of Dr. Cocoa

Successful track record of acquisitions, in-licensing and co-promotions, which have broadened and diversified product portfolio

Continued expansion of branded and generic product lines

Acquired contract manufacturer Great Southern Labs

Investment Highlights

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Page 4: Investor Presentation (NASDAQ: PTX) - Pernix | · PDF fileThe following presentation includes “f orward-looking statements ... OTC Monograph Cough-related IP ... FDA approval of

Positioned for Long-Term Growth

($ in millions)

4Revenue CAGR 2007-2012

$14.8

$20.7

$27.9

$33.2

$60.6 $61.3

$0.0

$10.0

$20.0

$30.0

$40.0

$50.0

$60.0

$70.0

2007 2008 2009 2010 2011 2012

Page 5: Investor Presentation (NASDAQ: PTX) - Pernix | · PDF fileThe following presentation includes “f orward-looking statements ... OTC Monograph Cough-related IP ... FDA approval of

Expanded Product Portfolio with Recent Aquisitions

Branded Products Indication

Bronchitis, ear and throat infections

Topical treatment of head lice

Treatment of H. pylori infection and duodenal ulcer disease

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Broad line of generic products

Generic Products

Treatment of cough and nasal congestion

Treatment of insomnia

OTC Products

OTC chocolate flavored cough and cold productDr. Cocoa

Various generic products

Page 6: Investor Presentation (NASDAQ: PTX) - Pernix | · PDF fileThe following presentation includes “f orward-looking statements ... OTC Monograph Cough-related IP ... FDA approval of

CedaxGenericsNatroba

Cough& ColdOmeclamox-Pak

Contract Manufacturing

Cough & ColdCedax

GenericsNatroba

Growing and Diversifying Revenues

2010

2011

2012

CedaxGenericsNatroba

Cough and Cold

Branded Products:Pernix/Hawthorn

Re-launch Silenor

Generics:Macoven/Cypress

Launch Dr. Cocoa

Launch New Generic and Branded Products

Cedax, Zutripro, Spinosadand Omeclamox Pak

Contract Manufacturing

2013

Branded Products: Pernix

Generics: Macoven

Cedax, Spinosad and Omeclamox Pak

Contract Manufacturing

Cough & Cold

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Page 7: Investor Presentation (NASDAQ: PTX) - Pernix | · PDF fileThe following presentation includes “f orward-looking statements ... OTC Monograph Cough-related IP ... FDA approval of

Dr. Cocoa

SILENOR ® Insomnia

Pernix Product Pipeline: Branded, Generic, OTC

PTX-007Upper Respiratory (Pediatric)

PTX-HA2Dermatology

PTX-HA5Renal Disease

Compound / Indication Pre-Clinical Phase 1 Phase 2 Phase 3 File Launch

OTC PIPELINE

GENERIC PIPELINE

12 ANDAs filed with the FDA: ANDA and NDA approved Feb. 2013

BRANDED PRESCRIPTION PIPELINE

Expected launch second half 2013

Expected launch 2016

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Page 8: Investor Presentation (NASDAQ: PTX) - Pernix | · PDF fileThe following presentation includes “f orward-looking statements ... OTC Monograph Cough-related IP ... FDA approval of

Combined Pernix/Hawthorn sales force of approximately 125 reps

Unique hiring process

Unlimited commission payout with modest base pay

Approximately 13 calls per day per sales rep

Focus on highly-populated states and high-prescribing physicians

Demonstrated ability to execute new product launches

Flexibility to change sales force focus rapidly

Performance-Driven Sales Force

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Page 9: Investor Presentation (NASDAQ: PTX) - Pernix | · PDF fileThe following presentation includes “f orward-looking statements ... OTC Monograph Cough-related IP ... FDA approval of

29

141

422

517

684645

944

1079

1196

10071060

1249

94143 156

194 196

270299

342383

338 352407

4786 94

118

190

412388 376

451 467500 478

Week 1 Week 2 Week 3 Week 4 Week 5 Week 6 Week 7 Week 8 Week 9 Week 10 Week 11 Week 12

Natroba Sklice Spinosad

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Pernix vs. Sanofi in the Head Lice Market

55 Natroba

Reps

300 SkliceReps

Pernix outperformed Sanofi in the first 12 weeks of product launch

Page 10: Investor Presentation (NASDAQ: PTX) - Pernix | · PDF fileThe following presentation includes “f orward-looking statements ... OTC Monograph Cough-related IP ... FDA approval of

Growth Through Horizontal Integration

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Branded RxPernix/Hawthorn

Generic RxMacoven/Cypress

OTCOTC MonographCough-related IP

AntibioticsCough & Cold

GastroenterologyLice ProductsDermatology

OphthalmologyPain

VitaminsInsomnia

AntibioticsCough & ColdDermatology

GastroenterologyPain

VitaminsLice Products

Ophthalmology

Cough and ColdDermatology

GastroenterologyVitamins

Lice ProductsOphthalmology

PainInsomnia

Acquire and Grow Grow with Generic Co-Pay Build/Maintain Brand

Build a brand with an effective sale force and transition to OTC

Repackage OTC Products with Rx products to offer added benefits

Page 11: Investor Presentation (NASDAQ: PTX) - Pernix | · PDF fileThe following presentation includes “f orward-looking statements ... OTC Monograph Cough-related IP ... FDA approval of

Strategic Plan for Future Growth

Grow branded sales of Pernix/Hawthorn and generic sales of Macoven/CypressLaunch Dr. Cocoa andVituz, re-launch Silenor

Launch pediatric dermatology product

Continue to expand into newmarkets and leverage coreexpertise.

Launch end-stage renal disease product and dermatology product.

Launch OTC Silenor

Near-Term Medium-Term Long-Term

Leverage combined sales forces; Grow generics; and Launch first OTC product

Advance low risk product development pipeline;Launch generic ANDAs; and branded products

Launch generic ANDAs and branded products and low-risk development programs: OTC Silenor

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Page 12: Investor Presentation (NASDAQ: PTX) - Pernix | · PDF fileThe following presentation includes “f orward-looking statements ... OTC Monograph Cough-related IP ... FDA approval of

Key Objectives for 2013

Integrate Cypress and Hawthorn and Capitalize on Synergies

Initiate the Phase III clinical trial of our pediatric product in mid-2013

Launch Dr. Cocoa for the 2013-2014 cough & cold season

Begin development of Silenor as an OTC product

Launch Vituz and generic products

Work toward IND filings in the areas of end stage renal disease and dermatology

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Page 13: Investor Presentation (NASDAQ: PTX) - Pernix | · PDF fileThe following presentation includes “f orward-looking statements ... OTC Monograph Cough-related IP ... FDA approval of

Dr. Cocoa: OTC Product Launch

An OTC chocolate flavored cough and cold product

Dr. Cocoa launch is expected for the 2013-2014 cough and cold season

Product line includes daytime, nighttime cough, cold and fever formulations

Market research has validated Dr. Cocoa’s flavor and packaging

Received positive feedback and strong interest from retailers

Won Best New Product at the cough, cold, analgesics, and allergy ECRM Conference

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Page 14: Investor Presentation (NASDAQ: PTX) - Pernix | · PDF fileThe following presentation includes “f orward-looking statements ... OTC Monograph Cough-related IP ... FDA approval of

Dr. Cocoa Product Line

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Page 15: Investor Presentation (NASDAQ: PTX) - Pernix | · PDF fileThe following presentation includes “f orward-looking statements ... OTC Monograph Cough-related IP ... FDA approval of

Dr. Cocoa Packaging

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Page 16: Investor Presentation (NASDAQ: PTX) - Pernix | · PDF fileThe following presentation includes “f orward-looking statements ... OTC Monograph Cough-related IP ... FDA approval of

Product Portfolio

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Page 17: Investor Presentation (NASDAQ: PTX) - Pernix | · PDF fileThe following presentation includes “f orward-looking statements ... OTC Monograph Cough-related IP ... FDA approval of

Omeclamox Launched July 2012

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Omeclamox – Triple therapy that combines omeprazole, clarithromycin and amoxicillin

Omeprazole is one of the most widely-prescribed products for gastroesophageal reflux disease (GERD)

10-day course of therapy to treat H. pylori with duodenal ulcer disease

Shorter duration of therapy compared to the top brand competitor and lower cost to the patient

Gastroenterology sales force launched the product in July 2012

Page 18: Investor Presentation (NASDAQ: PTX) - Pernix | · PDF fileThe following presentation includes “f orward-looking statements ... OTC Monograph Cough-related IP ... FDA approval of

Key Growth Driver – Cedax

CEDAX is a third generation oral cephalosporin indicated for the treatment of mild-to-moderate acute bacterial exacerbations of chronic bronchitis, and also middle ear infection due to haemophilusinfluenza or streptococcus pyogenes

Acquired the CEDAX product line from Shionogi in the H1:2010

Successful launch of 180mg suspension in January 2011

IP protection through 2014

Converting sales from government payers to commercial payers

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Page 19: Investor Presentation (NASDAQ: PTX) - Pernix | · PDF fileThe following presentation includes “f orward-looking statements ... OTC Monograph Cough-related IP ... FDA approval of

Effectiveness of CEDAX

76%

52%

41%36%

28%

22%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Cedax Suprax Amoxicillin Cefzil Ceclor Ceftin

Middle Ear Fluid (MEF) Penetration 1‐3

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Source: 1) Craig, WA, Andes D. Pharmokinetics and pharmacodynamics of antibiotics in otitis media. Pediatr Infect Dis J. 1996; 15(3): 255-259.2) Physicians’ Desk Reference. Montvale, NJ: Thomson Medical Economics Company, Inc. 2003. Available at http://www.pdr.net3) Scaglione F, Demartinit G, Dugnani S, Arcidiacono, MM Pintucci JP, Frashchini. Interpretations of middle ear fluid concentrations of antibiotics: comparison between ceftibuten, cefixime and azithromcin; F. Br J clin Pharmacol. 1999; 47:267-271

Page 20: Investor Presentation (NASDAQ: PTX) - Pernix | · PDF fileThe following presentation includes “f orward-looking statements ... OTC Monograph Cough-related IP ... FDA approval of

■ Natroba (spinosad), branded prescription treatment for head lice

■ Exclusive co-promotion agreement with ParaPro

■ Launched in August 2011 for the lice season with adequate product supply by ParaPro

■ IP protection through 2021■ Natural non-neurotoxic pediculocide (no black

box warning)■ No nit combing required and typically only one

application.■ Significantly more effective in eliminating head

lice than permethrin 1% (Nix) in two Phase III studies

Natroba: Best in Class

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Page 21: Investor Presentation (NASDAQ: PTX) - Pernix | · PDF fileThe following presentation includes “f orward-looking statements ... OTC Monograph Cough-related IP ... FDA approval of

Q4 2010 – Completed acquisition of Macoven Pharmaceuticals, a generic business platform for Pernix

Strengthened generic platform with Cypress acquisition in Q4 2012

Launched more than 25 generic products in 2011 and 2012

Launched several generic products outside of cough and cold market

Launched Spinosad (generic Natroba) in August 2012

For the full year of 2012, Macoven was approximately 36% of the Company’s total net sales

Macoven Pharmaceuticals

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Page 22: Investor Presentation (NASDAQ: PTX) - Pernix | · PDF fileThe following presentation includes “f orward-looking statements ... OTC Monograph Cough-related IP ... FDA approval of

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Page 23: Investor Presentation (NASDAQ: PTX) - Pernix | · PDF fileThe following presentation includes “f orward-looking statements ... OTC Monograph Cough-related IP ... FDA approval of

In December 2012, Pernix acquired Hawthorn/Cypress for $102 million

Significantly increases and broadens Pernix’s branded and generic product portfolio

Provides pipeline of generic ANDAs and branded NDAs and products in development

Enhances clinical and regulatory expertise

Provides cost savings

Accelerates the execution of our horizontal integration strategy

Pernix and Cypress/Hawthorn are a Strong Combination

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Page 24: Investor Presentation (NASDAQ: PTX) - Pernix | · PDF fileThe following presentation includes “f orward-looking statements ... OTC Monograph Cough-related IP ... FDA approval of

Cypress/Hawthorn Overview

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Well-established generic and specialty branded pharmaceutical company with diverse product portfolio

Cypress develops, markets and distributes generics

Strong product pipeline

Cypress is a key customer of Pernix Manufacturing

Hawthorn Pharmaceuticals is focused on the development and marketing of branded prescription products

Located in Madison, Mississippi and founded in 1993

Page 25: Investor Presentation (NASDAQ: PTX) - Pernix | · PDF fileThe following presentation includes “f orward-looking statements ... OTC Monograph Cough-related IP ... FDA approval of

Key Hawthorn Brand Products

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Zutripro - Hydrocodone/chlorpheniramine/pseudoephedrine (Zutripro)

Rezira - Hydrocodone/pseudoephedrine

Developed in response to FDA action removing all HCD cough/cold DESI products in 2008

Only immediate-release HCD products on the market

Zutripro and Rezira were launched in Fall of 2011

Vituz - Hydrocodone/chlorpheniramine

Received FDA approval in Feb. 2013

Complements Zutripro and Rezira

Page 26: Investor Presentation (NASDAQ: PTX) - Pernix | · PDF fileThe following presentation includes “f orward-looking statements ... OTC Monograph Cough-related IP ... FDA approval of

Cypress/Hawthorn Product Development Expertise

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11 ANDAs approved last three years

Two - 505(b)(2) NDAs approved in 2011 (Zutripro & Rezira)

12 - ANDAs on file

1 - 505(b)(2) NDA on file

Broad pipeline of products at various stages

Cough/cold/respiratory, pain, renal, dietary supplements, fluorides/dental care

Page 27: Investor Presentation (NASDAQ: PTX) - Pernix | · PDF fileThe following presentation includes “f orward-looking statements ... OTC Monograph Cough-related IP ... FDA approval of

Completed acquisition of Somaxon in March 2013

Acquired Somaxon in a stock-for-stock transaction with a total equity value of $25 million (3.7 million shares of PTX)

Silenor is a non-seasonal product that broadens our branded product pipeline

Re-launch of Silenor by combined Hawthorn sales forces in second

quarter 2013.

Pernix Acquired Somaxon

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Page 28: Investor Presentation (NASDAQ: PTX) - Pernix | · PDF fileThe following presentation includes “f orward-looking statements ... OTC Monograph Cough-related IP ... FDA approval of

Silenor for the Treatment of Insomnia

• Branded prescriptive product for the treatment of insomnia characterized by difficulty with sleep maintenance

• Silenor not a controlled substance

• Silenor demonstrated sleep maintenance including the seventh and eight hours into the night

• No meaningful next day residual effects and an overall adverse events profile similar to placebo

• Plan to develop Silenor as OTC product

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Page 29: Investor Presentation (NASDAQ: PTX) - Pernix | · PDF fileThe following presentation includes “f orward-looking statements ... OTC Monograph Cough-related IP ... FDA approval of

Summary

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Page 30: Investor Presentation (NASDAQ: PTX) - Pernix | · PDF fileThe following presentation includes “f orward-looking statements ... OTC Monograph Cough-related IP ... FDA approval of

Acquired Somaxon March 2013

FDA approval of Vituz and mefenamic acid February 2013

Acquired Cypress and Hawthorn December 2012

Launched Spinosad (Generic Natroba) August 2012

Acquired Great Southern Laboratories July 2012

Launch of Omeclamox-pak July 2012

Launch of Natroba August 2011

Launch of Cedax 180mg January 2011

Key Milestones

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Page 31: Investor Presentation (NASDAQ: PTX) - Pernix | · PDF fileThe following presentation includes “f orward-looking statements ... OTC Monograph Cough-related IP ... FDA approval of

Key Objectives for 2013

• Integrate Cypress and Hawthorn and Capitalize on Synergies

• Initiate the Phase III clinical trail of our pediatric product in mid-2013

• Launch Dr. Cocoa for the 2013-2014 cough & cold season

• Begin development of Silenor as an OTC product

• Work toward IND filings in the areas of end stage renal disease and dermatology

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Page 32: Investor Presentation (NASDAQ: PTX) - Pernix | · PDF fileThe following presentation includes “f orward-looking statements ... OTC Monograph Cough-related IP ... FDA approval of

Financial Results

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Page 33: Investor Presentation (NASDAQ: PTX) - Pernix | · PDF fileThe following presentation includes “f orward-looking statements ... OTC Monograph Cough-related IP ... FDA approval of

Continued Revenue Growth in 2012($, in Millions Except

Per Share Data)Years Ended December 31

2012 2011

Net Revenues $61.3 $60.6

Gross Profit 37.9 39.7

SG&A Expense 35.5 22.5

R&D Expense 0.7 0.9

Loss from the operations of JV 0.2 0.8

Depreciation & Amortization 3.2 2.3

Income (loss) from Operations (1.7) 13.1

Adjusted EBITDA 5.9(1) 17.4

Net Income (loss) (1.4) 8.3

Earnings (loss) per Share, diluted $(0.05) $0.34

Weighted Avg. Shares Outstanding, diluted 28.1 24.5

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(1) The Company defines adjusted EBITDA as net income plus income taxes, interest, depreciation and amortization, and further eliminates the impact of non-cash stock compensation expenses and acquisition expenses.

Page 34: Investor Presentation (NASDAQ: PTX) - Pernix | · PDF fileThe following presentation includes “f orward-looking statements ... OTC Monograph Cough-related IP ... FDA approval of

Solid Financial Position

As of December 31, 2012 ($, in millions)

Cash and Cash Equivalents $23.0

Accounts Receivable, net 36.6

Inventory, net 22.0

Working Capital 41.8

Total Assets 251.4

Total Debt 44

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Page 35: Investor Presentation (NASDAQ: PTX) - Pernix | · PDF fileThe following presentation includes “f orward-looking statements ... OTC Monograph Cough-related IP ... FDA approval of

Corporate Headquarters: The Woodlands, TX Distribution Centers in Magnolia, TX & Gonzales, LA

Page 36: Investor Presentation (NASDAQ: PTX) - Pernix | · PDF fileThe following presentation includes “f orward-looking statements ... OTC Monograph Cough-related IP ... FDA approval of

Investor Presentation(NASDAQ: PTX)