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| 8-K - CURRENT REPORT - NOVADEL PHARMA INC | form8kx.htm |
NovaDel Pharma Inc.
Positioned for Growth
Annual Meeting
June 10, 2010
Forward Looking Statement
Except for historical information contained herein, this presentation may contain forward-looking statements
within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve known and
unknown risks and uncertainties that may cause the Company's actual results or outcomes to be materially
different from those anticipated and discussed herein including, but not limited to, the ability of third parties to
commercialize the Company's products, the successful completion of its pilot pharmacokinetic feasibility studies,
the ability to develop products (independently and through collaborative arrangements), the Company's ability to
obtain additional required financing to fund its research programs, the ability to commercialize and obtain FDA
and other regulatory approvals for products under development, and the acceptance in the marketplace for oral
spray products. The filing of an NDA with the FDA is an important step in the approval process in the United
States. Acceptance for filing by the FDA does not mean that the NDA has been or will be approved, nor does it
represent an evaluation of the adequacy of the data submitted. Further, the Company operates in industries
where securities may be volatile and may be influenced by regulatory and other factors beyond the Company's
control. In addition, 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 of our products could materially impact the Company's actual results.
Important factors that the Company believes might cause such differences are discussed in the risk factors
detailed in the Company's most recent Annual Report on Form 10-K and Registration Statements, filed with the
Securities and Exchange Commission. In assessing forward-looking statements contained herein, if any, the reader
is urged to carefully read all cautionary statements contained in such filings.
within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve known and
unknown risks and uncertainties that may cause the Company's actual results or outcomes to be materially
different from those anticipated and discussed herein including, but not limited to, the ability of third parties to
commercialize the Company's products, the successful completion of its pilot pharmacokinetic feasibility studies,
the ability to develop products (independently and through collaborative arrangements), the Company's ability to
obtain additional required financing to fund its research programs, the ability to commercialize and obtain FDA
and other regulatory approvals for products under development, and the acceptance in the marketplace for oral
spray products. The filing of an NDA with the FDA is an important step in the approval process in the United
States. Acceptance for filing by the FDA does not mean that the NDA has been or will be approved, nor does it
represent an evaluation of the adequacy of the data submitted. Further, the Company operates in industries
where securities may be volatile and may be influenced by regulatory and other factors beyond the Company's
control. In addition, 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 of our products could materially impact the Company's actual results.
Important factors that the Company believes might cause such differences are discussed in the risk factors
detailed in the Company's most recent Annual Report on Form 10-K and Registration Statements, filed with the
Securities and Exchange Commission. In assessing forward-looking statements contained herein, if any, the reader
is urged to carefully read all cautionary statements contained in such filings.
For more detailed information regarding NovaDel's 2009 financial results and its product pipeline, please review
the Company's SEC filings on Form 10-Q at the Investor Relations section of www.novadel.com.
the Company's SEC filings on Form 10-Q at the Investor Relations section of www.novadel.com.
NovaDel Oral Spray Drugs
• Patent protected technology
• Rapid onset
• Improved safety profile
• Ease of use
NovaMist® Advantages
Substantial Progress in 2009
• Nitromist and Zolpimist licensed
• Operating costs reduced
• Converted debt to equity
Financial Metrics
• $4.0 million in working capital at 3-31-10
• Clean balance sheet-no debt
• Approximately 98 million shares outstanding
• Major shareholder holds about 40%
• Management holds about 5%
• Market cap approximately $20 million
• Royalty income anticipated in 2010
• Significant product opportunity- Duromist™
• Development milestones clear and near term
• Capital raise required to complete plan
Positioned for Growth
Positioned for Growth
Two product launches in 2010
Nitromist™
• FDA-approved nitroglycerine oral spray for the
treatment of angina
treatment of angina
• Advantage compared to tablet formulation
nitroglycerine is ease of use and durable
potency
nitroglycerine is ease of use and durable
potency
• Current market size $200 million
Zolpimist™
• FDA-approved proprietary zolpidem tartrate
oral spray for the treatment of insomnia
oral spray for the treatment of insomnia
• Active ingredient in multiple approved
treatments for insomnia including Ambien®
treatments for insomnia including Ambien®
• Advantage of oral spray version is ease-of-use
• Insomnia market size $1.5 billion
Positioned for Growth
Duromist™
Positioned for Growth
• Initiating development of Duromist™, the sildenafil
oral spray for the treatment of ED (the active
ingredient in Viagra®)
oral spray for the treatment of ED (the active
ingredient in Viagra®)
• Same technology and regulatory pathway as our two
approved products
approved products
• Development plan anticipates FDA approval about
when Viagra® patent protection ends in 2012
when Viagra® patent protection ends in 2012
• Clinical data on Duromist™ before year end
• Commercialization opportunities
Erectile Dysfunction Market
• Multi-billion dollar market
• Viagra® dominates with half the market
• Viagra® patent expires Q2 2012
• Active generic market anticipated with innovative
products in development for ED
products in development for ED
• Duromist™ is ideally positioned through ease of
administration and potential label differentiation
administration and potential label differentiation
Duromist™ Development Plan
• Q3 2010 Pilot PK trial completed
• Q1 2011 Clinical trial(s) initiated
• Q3 2011 NDA filed
• Allows product launch shortly after patent expiration
• Total development cost of $8-10 million
Commercialization Opportunities
• Building a commercial organization is not part of
our current strategy
our current strategy
• Anticipate retaining a marketing capability in a
licensing transaction
licensing transaction
• Internet provides a cost-effective method of
reaching potential patients
reaching potential patients
• Believe that NovaDel can develop this capability
Commercialization Opportunities
Product attributes well understood
• Improves important personal activity
• Widespread consumer and cultural awareness
• Extensive use
• Well-defined, favorable safety and side effect
profile
profile
• Wide dosing range enables dosing titration
Internet: Increased Options
to Reach Patients
to Reach Patients
Pharmacy
Doctor
= Communication
pathways
facilitated via
Internet
pathways
facilitated via
Internet
Patient
Positioned for Growth
• Royalty income begins in 2010
• Significant product opportunity- Duromist™
• Development milestones clear and near term
• Capital raise required to complete plan
NovaDel Pharma Inc.
Positioned for Growth
Annual Meeting
June 10, 2010