Investor Presentation (NASDAQ: PTX) Safe Harbor Statement 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. 2 Investment Highlights 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 3 Positioned for Long-Term Growth ($ in millions) $70.0 $60.6 $61.3 2011 2012 $60.0 $50.0 $40.0 $33.2 $30.0 $27.9 $20.7 $20.0 $14.8 $10.0 $0.0 2007 2008 2009 2010 Revenue CAGR 2007-2012 4 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 Treatment of cough and nasal congestion Treatment of insomnia Generic Products Various generic products Broad line of generic products OTC Products Dr. Cocoa OTC chocolate flavored cough and cold product 5 Growing and Diversifying Revenues 2013 2012 2011 Branded Products: Pernix/Hawthorn Re-launch Silenor 2010 Cough & Cold Cedax& Cold Cough Generics Cedax Natroba Generics CoughNatroba and Cold Cedax Pernix Branded Products: Generics Natroba Generics: Macoven Cough& Cold Omeclamox-Pak Cedax, Spinosad and Contract Manufacturing Omeclamox Pak Generics: Macoven/Cypress Launch Dr. Cocoa Launch New Generic and Branded Products Contract Manufacturing Cedax, Zutripro, Spinosad and Omeclamox Pak Contract Manufacturing 6 Pernix Product Pipeline: Branded, Generic, OTC BRANDED PRESCRIPTION PIPELINE Compound / Indication Pre-Clinical Phase 1 Phase 2 Phase 3 File Launch PTX-007 Upper Respiratory (Pediatric) PTX-HA2 Dermatology PTX-HA5 Renal Disease OTC PIPELINE Dr. Cocoa Expected launch second half 2013 SILENOR ® Insomnia Expected launch 2016 GENERIC PIPELINE 12 ANDAs filed with the FDA: ANDA and NDA approved Feb. 2013 7 Performance-Driven Sales Force 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 8 Pernix vs. Sanofi in the Head Lice Market Pernix outperformed Sanofi in the first 12 weeks of product launch Natroba Sklice Spinosad 55 Natroba Reps 1249 1196 1079 1060 1007 944 684 645 517 500 422 412 388 376 270 352 Week 10 Week 11 300 Sklice Reps 196 190 194 29 338 299 156 141 143 94 407 383 342 478 467 451 86 94 Week 2 Week 3 118 47 Week 1 Week 4 Week 5 Week 6 Week 7 Week 8 Week 9 Week 12 9 Growth Through Horizontal Integration Build a brand with an effective sale force and transition to OTC Branded Rx Generic Rx OTC Pernix/Hawthorn Macoven/Cypress OTC Monograph Cough-related IP Repackage OTC Products with Rx products to offer added benefits Acquire and Grow Antibiotics Cough & Cold Gastroenterology Lice Products Dermatology Ophthalmology Pain Vitamins Insomnia Grow with Generic Co-Pay Antibiotics Cough & Cold Dermatology Gastroenterology Pain Vitamins Lice Products Ophthalmology Build/Maintain Brand Cough and Cold Dermatology Gastroenterology Vitamins Lice Products Ophthalmology Pain Insomnia 10 Strategic Plan for Future Growth Near-Term Grow branded sales of Pernix/Hawthorn and generic sales of Macoven/Cypress Launch Dr. Cocoa and Vituz, re-launch Silenor Leverage combined sales forces; Grow generics; and Launch first OTC product Medium-Term Long-Term Launch pediatric dermatology product Launch end-stage renal disease product and dermatology product. Continue to expand into new markets and leverage core expertise. Launch OTC Silenor 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 11 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 12 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 13 Dr. Cocoa Product Line 14 Dr. Cocoa Packaging 15 Product Portfolio 16 Omeclamox Launched July 2012 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 17 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 haemophilus influenza 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 18 Effectiveness of CEDAX Middle Ear Fluid (MEF) Penetration 1‐3 100% 90% 80% 76% 70% 60% 52% 50% 41% 40% 36% 28% 30% 22% 20% 10% 0% Cedax Suprax Amoxicillin Cefzil Ceclor Ceftin 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.net 3) 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 19 Natroba: Best in Class ■ ■ ■ ■ ■ ■ ■ 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 20 Macoven Pharmaceuticals 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 21 22 Pernix and Cypress/Hawthorn are a Strong Combination 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 23 Cypress/Hawthorn Overview 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 24 Key Hawthorn Brand Products 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 25 Cypress/Hawthorn Product Development Expertise 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 26 Pernix Acquired Somaxon Completed acquisition of Somaxon in March 2013 Acquired Somaxon in a stock-for-stock transaction with a total equity value of $25 million (3.7 million shares of PTX) Silenor is a non-seasonal product that broadens our branded product pipeline Re-launch of Silenor by combined Hawthorn sales forces in second quarter 2013. 27 Silenor for the Treatment of Insomnia • Branded prescriptive product for the treatment of insomnia characterized by difficulty with sleep maintenance • Silenor not a controlled substance • Silenor demonstrated sleep maintenance including the seventh and eight hours into the night • No meaningful next day residual effects and an overall adverse events profile similar to placebo • Plan to develop Silenor as OTC product 28 Summary 29 Key Milestones Acquired Somaxon FDA approval of Vituz and mefenamic acid Acquired Cypress and Hawthorn March 2013 February 2013 December 2012 Launched Spinosad (Generic Natroba) August 2012 Acquired Great Southern Laboratories July 2012 Launch of Omeclamox-pak July 2012 Launch of Natroba Launch of Cedax 180mg August 2011 January 2011 30 Key Objectives for 2013 • Integrate Cypress and Hawthorn and Capitalize on Synergies • Initiate the Phase III clinical trail of our pediatric product in mid-2013 • Launch Dr. Cocoa for the 2013-2014 cough & cold season • Begin development of Silenor as an OTC product • Work toward IND filings in the areas of end stage renal disease and dermatology 31 Financial Results 32 Continued Revenue Growth in 2012 ($, in Millions Except Per Share Data) Years Ended December 31 2012 2011 $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 Net Revenues Earnings (loss) per Share, diluted $(0.05) $0.34 Weighted Avg. Shares Outstanding, diluted 28.1 24.5 (1) The Company defines adjusted EBITDA as net income plus income taxes, interest, depreciation and amortization, and further eliminates the impact of non-cash stock compensation expenses and acquisition expenses. 33 Solid Financial Position As of December 31, 2012 ($, in millions) Cash and Cash Equivalents $23.0 Accounts Receivable, net 36.6 Inventory, net 22.0 Working Capital 41.8 Total Assets Total Debt 251.4 44 34 Corporate Headquarters: The Woodlands, TX Distribution Centers in Magnolia, TX & Gonzales, LA Investor Presentation (NASDAQ: PTX)
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