Attached files
| file | filename |
|---|---|
| 8-K - CURRENT REPORT - PERNIX THERAPEUTICS HOLDINGS, INC. | ptx_8k.htm |
| EX-99.2 - PRESS RELEASE - PERNIX THERAPEUTICS HOLDINGS, INC. | ptx_ex992.htm |
EXHIBIT 99.1
Investor Presentation
January 2011
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.
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.
property of their respective owners. ©2010 Pernix Therapeutics Holdings, Inc.
2
Safe Harbor Statement
3
Pernix Today
Integrated Specialty Pharmaceutical Business
Gross sales of $38.3 million in 2009, three-year CAGR of 41.5%;
Profitable and generating cash flow
Strong IP-Driven Operating Model
Focus on branded pediatric products with high gross margins / low cap ex
requirements; 23 trademark interests as of August 16, 2010
requirements; 23 trademark interests as of August 16, 2010
Low Product Development Risk
Actively manage product mix to meet customer demand and leverage sales
force
force
Excellent Financial Position
$6.5 million in cash, net of borrowings on line of credit, as of September 30,
2010
2010
Corporate Structure
Pernix Therapeutics, LLC
(Branded Pharmaceutical Products)
Macoven Pharmaceuticals, LLC
(Generic business)
Wholly-owned subsidiary
Gaine, Inc.
(Intellectual Property Assets)
Wholly-owned subsidiary
Pernix Therapeutics Holdings, Inc.
(Corporate)
■ Received FDA Approval for Human Head Lice Treatment
in January 2011
in January 2011
o Product available in the first half of 2011
■ Formed Joint Venture with UK Development Company in
December 2010
December 2010
o $1.5 million investment to fund late-stage development of
theobromine-based treatment for persistent cough
theobromine-based treatment for persistent cough
■ Acquired Macoven Pharmaceuticals for $2.2 Million in
September 2010
September 2010
o Profitable business focused on development of generic
pharmaceuticals and sale of authorized generic products
pharmaceuticals and sale of authorized generic products
■ Repurchased 2 Million Shares of Common Stock in
September 2010
September 2010
5
Recent Milestones
6
Strategic Plan
Grow sales of
Cedax and other
existing products
existing products
Identify new
collaborations;
Accretive
collaborations;
Accretive
acquisitions
Develop new
products; Expand
into new markets
beyond pediatrics
products; Expand
into new markets
beyond pediatrics
Near-Term
Medium-Term
Long-Term
Utilize sales force of
55 representatives
in pediatrics
55 representatives
in pediatrics
Consider product
expansion by
acquisition, in-licensing
and co-promotion
expansion by
acquisition, in-licensing
and co-promotion
Utilize lower risk
regulatory pathways
for development
projects to lower cost
and risk exposure
regulatory pathways
for development
projects to lower cost
and risk exposure
7
|
Products
|
Active Categories
|
|
Aldex Family
|
Cold/Cough
|
|
BC1036**
|
Antitussive
|
|
Brovex Family
|
Cold/Cough
|
|
Cedax
|
Antibiotic
|
|
Natroba
|
Head Lice
|
|
Pediatex Family
|
Cold/Cough
|
|
QuinZyme*
|
Cardiovascular
|
|
ReZyst IM
|
Gastro-Probiotic
|
|
Z-Cof Family
|
Cold/Cough
|
|
Zema-Pak
|
Corticosteroid Therapy
|
Current Product Portfolio
* Partnering Opportunities
** Currently in Clinical
Development Stage
Development Stage
8
Current/Future Sales Force
2009 Total Employees: ~80
2010 Sales Representatives: 55
2010 Q4 Sales Force Additions: 10-12 (Goal)
2011 and beyond - increase reach to mid-decile prescribers with increased frequency
9
Sales Force Efficiency
• Pernix sales force averaged almost
560 RX’s per rep for the Pediatex TD
Product in the 4th month of the launch
560 RX’s per rep for the Pediatex TD
Product in the 4th month of the launch
Launch of Pediatex
Launch of Brovex
• Pernix acquired the Brovex product
line for $450,000 in June 2009
line for $450,000 in June 2009
• Following the product launch in August
2009, the Pernix sales force achieved
approximately $7 Million in sales and
averaged over 1600 Rx’s per rep from
product launch in August 2009 to
December 2009
2009, the Pernix sales force achieved
approximately $7 Million in sales and
averaged over 1600 Rx’s per rep from
product launch in August 2009 to
December 2009
o Only competing third generation cephalosporin product
generated nearly $100 million of sales at retail in 2009
generated nearly $100 million of sales at retail in 2009
o Opportunity to expand into oral solid market through
co-promotion efforts
■ Indicated Treatment for Middle Ear Infections
o Antibiotics are promotion sensitive and highly prescribed in
pediatrics
pediatrics
■ U.S. Rights Acquired from Shionogi Pharma on March 24,
2010
2010
o Paid $6.1 Million, or 1x sales (not actively promoted in 2009)
■ NDA Product with Orange Book Protection Through 2014
■ POA - First Position During Respiratory Season
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■ Pernix expects to receive payments between 35%-42% of net sales
proceeds
proceeds
■ Received FDA Approval for Use in Patients Ages 4 and Up in January
2011
2011
o According to two phase III studies, the product was shown as significantly
more effective in eliminating head lice than permethrin 1% (Nix, AAP
recommended treatment)
more effective in eliminating head lice than permethrin 1% (Nix, AAP
recommended treatment)
o Resolves most head lice problems in about 10 minutes with just one
application and no nit combing
application and no nit combing
■ First Half 2011 - Combined Sales Forces Launching Product to
Healthcare Professionals in the U.S.
Healthcare Professionals in the U.S.
o Pernix receives monthly payments based on sales volume
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Natroba™
12
Growth Strategy
§ Profitable Generics Division
o Provides opportunity for alternative revenue stream,
authorized generics
authorized generics
o Transaction funded with initial draw on line of credit
§ Launched 11 Generic Pharmaceutics in 2010
o Includes five authorized generic equivalents of Pernix branded
products, as of September 30, 2010
products, as of September 30, 2010
§ Acquired Right to Exclusively Market ZEMA PAK® in
Q2 2010
Q2 2010
o Corticosteroid used for treating skin rashes; helps diversify
product mix from winter season cough and cold products
product mix from winter season cough and cold products
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Macoven Pharmaceuticals
§ Identify Partners to Efficiently and Cost Effectively
Bring New Products to Market
Bring New Products to Market
§ Rights to 8 Product Candidates as of August 16, 2010
o Four antitussive product candidates
o Two product candidates to treat symptoms associated with
dermatitis
dermatitis
o One product candidate in our Z-COF product line
o One product candidate in our PEDIATEX product line
14
Development Pipeline
§ Joint Venture Formed with SEEK (UK) to Develop Codeine-Free
Cough Suppressant (BC1036)
Cough Suppressant (BC1036)
o Pernix believes this antitussive candidate has potential to address the
need for a safer and more effective, non-opioid treatment for persistent
cough
need for a safer and more effective, non-opioid treatment for persistent
cough
o Pernix contributed $1.5 million and its theobromine IP (Patent Number
6,348,470) for a 50% voting stake in the JV
6,348,470) for a 50% voting stake in the JV
§ Manfred Scheske will lead the JV and oversee development of
BC1036
BC1036
o Former President of Consumer Healthcare Europe at GlaxoSmithKline
§ Current Regulatory Path
o Intends to begin a Phase III clinical trial in Europe in first half of 2011
o Initiated preliminary discussions with FDA to confirm regulatory path in
U.S.
U.S.
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Natural Cough Suppressant
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Management Team
|
|
Title
|
|
Cooper Collins
|
President and Chief Executive Officer
|
|
Tracy Clifford
|
Chief Financial Officer, Secretary and
Treasurer |
|
Robert Cline
|
Vice President, Operations and Supply
Chain Management |
|
Mike Venters
|
Vice President, Corporate Development
|
|
Beth DeVille
|
Vice President, Sales and Marketing
|
§ Seasoned Senior Management Team with
Approximately 60 Years of Combined
Experience in the Pharmaceutical Industry
Approximately 60 Years of Combined
Experience in the Pharmaceutical Industry
17
Market Opportunity
§ Cold/Cough Sector-Annual Sales in Excess of $2 billion1
§ Over 35.9 Million People have Seasonal Allergic Rhinitis,
Accounting for $4.5 Billion Spent on Direct Care2
Accounting for $4.5 Billion Spent on Direct Care2
§ Allergic Disease Affects More Than 20% of the Population and is the
3rd Leading Chronic Disease Among Children Under 18 Years of
Age2
3rd Leading Chronic Disease Among Children Under 18 Years of
Age2
§ Opportunity: Limited Competition in Prescription Cough/Cold
Space, Especially Pediatrics
Space, Especially Pediatrics
o Cold/Cough product sales were $5.4 billion in the 52-week period ended
April 17, 20103
April 17, 20103
o Competition from OTC treatments including Sudafed PE, Robitussin®
CF, Tylenol® Sinus and Theraflu®
CF, Tylenol® Sinus and Theraflu®
18
Cough and Cold Market
Sources:
1 - Journal Asthma
2 - American Academy of Allergy Asthma and Immunology
3 - SymphonyIRI Group
§ Over 5 Million Cases of Middle Ear Infections Occur Annually in
Children, Which Resulted in 10 Million Antibiotic Prescriptions per
Year1
Children, Which Resulted in 10 Million Antibiotic Prescriptions per
Year1
§ Middle Ear Infections are the Most Common Illnesses Experienced
by Babies and Young Children
by Babies and Young Children
o Number one cause of consultations with physicians
§ The U.S. Centers for Disease Control and Prevention estimates
between 6 to 12 million cases of head lice infestations each year
between 6 to 12 million cases of head lice infestations each year
o Most cases occur in children age 3 to 12 years old
o Second most communicable disease among school children
§ Direct and Indirect Costs of Head Lice Infestations in U.S. Estimated
at Over $1 Billion2
at Over $1 Billion2
19
Antibiotics and Lice Market
Source:
1 - American Academy of Pediatrics
2 - Lebwohl M, Clark L, Levitt J. Therapy for head lice based on life cycle,
resistance and safety considerations. Pediatrics 2007; 119(5): 965-974
resistance and safety considerations. Pediatrics 2007; 119(5): 965-974
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Financials
21
Historical sales growth driven by
increasing demand for Brovex,
Pediatex, Aldex and Z-Cof
products
increasing demand for Brovex,
Pediatex, Aldex and Z-Cof
products
Profitable Growth
Consistent growth in earnings
resulting from focus on high
margin product sales and lean
operating structure
resulting from focus on high
margin product sales and lean
operating structure
22
Condensed Income Statement
|
($, in millions except
per share data) |
Three Months
Ended September 30 |
Nine Months
Ended September 30 |
||
|
|
2010
|
2009
|
2010
|
2009
|
|
Net Sales
|
7.8
|
5.8
|
21.0
|
19.6
|
|
Gross Profit
|
6.3
|
4.1
|
17.7
|
15.4
|
|
Selling, General &
Administrative Expense |
3.3
|
2.3
|
9.4
|
7.4
|
|
Income from Operations
|
3.2
|
1.1
|
7.9
|
6.6
|
|
Net Income
|
2.4
|
1.1
|
7.8
|
6.7
|
|
Earnings per Share
|
0.10
|
0.05
|
0.33
|
0.32
|
|
Weighted Avg. Shares
Outstanding, basic |
24,390
|
20,900
|
23,635
|
20,900
|
|
Weighted Avg. Shares
Outstanding, diluted |
24,417
|
20,900
|
23,656
|
20,900
|
23
Financial Position
|
As of September 30, 2010 ($, in millions)
|
|
|
Cash and Cash Equivalents
|
8.2
|
|
Working Capital
|
5.6
|
|
Total Assets
|
36.6
|
|
Total Debt
|
2.2
|
|
For the Nine Months Ended September 30, 2010
($, in millions)
|
|
|
Cash Flow from Operations
|
2.1
|
|
CapEx
|
0.1
|
|
Free Cash Flow
|
2.0
|
Definition: We define free cash flow as net cash provided by operating
activities minus capital expenditures (purchase of equipment).
activities minus capital expenditures (purchase of equipment).
24
Investment Considerations
Integrated Specialty Pharmaceutical Business
Gross sales of $38.3 million in 2009, three-year CAGR of 41.5%;
Profitable and generating cash flow
Strong IP-Driven Operating Model
Focus on branded pediatric products with high gross margins / low cap ex
requirements; 23 trademark interests as of August 16, 2010
requirements; 23 trademark interests as of August 16, 2010
Low Product Development Risk
Actively manage product mix to meet customer demand and leverage sales
force
force
Excellent Financial Position
$6.5 million in cash, net of borrowings on line of credit, as of September 30,
2010
2010
Pernix Therapeutics Holdings, Inc.
NYSE Amex: PTX
Cooper Collins, President & CEO
33219 Forest West Drive
Magnolia, TX 77354
www.pernixtx.com
Thank You
25