Generic Products - Pernix Therapeutics

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)