Safe Harbor Statement

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Transcript Safe Harbor Statement

September 2007
Safe Harbor Statement
Safe Harbor Statement Under the Private Securities Litigation Act of 1995 -- With the exception of historical information, the matters
discussed herein are forward-looking statements that involve a number of risks and uncertainties. The actual future results of Urigen
could differ significantly from those statements. Factors that could cause actual results to differ materially include risks and uncertainties
such as the inability to finance the company's operations or expansion, inability to hire and retain qualified personnel, changes in the
general economic climate, including rising interest rate and unanticipated events such as terrorist activities. As with any new
pharmaceutical product, there are significant risks in development, regulatory approval and commercialization of Urigen’s products.
There are no guarantees that future clinical studies will confirm the preliminary results discussed in this document or that URG101 or
URG301or any other Urigen product will receive regulatory approval for any medical condition. Further, even if Urigen were to receive
regulatory approval for a product, there can be no assurance that such a product would prove to be commercially successful.
In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "expect," "plan," "anticipate,"
"believe," "estimate," "predict," "potential" or "continue," the negative of such terms, or other comparable terminology. These statements
are only predictions. Although we believe that the expectations reflected in the forward-looking statements are reasonable, such
statements should not be regarded as a representation by the Company, or any other person, that such forward-looking statements will
be achieved. We undertake no duty to update any of the forward-looking statements, whether as a result of new information, future
events or otherwise. In light of the foregoing, readers are cautioned not to place undue reliance on such forward-looking statements. For
further risk factors see the risk factors associated with our Company, please review our SEC filings.
Urigen Pharmaceuticals, Inc.
1
Commercialization
Strategy
Specialty pharmaceutical company targeting
urological disorders
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Two Products with $500M Potential Net Sales in US
US Launches conducted by Urigen
Co-Promotion Agreements in US an Option
Licensing and Distribution Agreements Outside the US
Urigen Pharmaceuticals, Inc.
2
Product Lines
Current Urological Product Lines
Bladder
URG101 – Bladder Instillation Solution
Proprietary solution of lidocaine & heparin
URG301 – Urethral Suppository
Proprietary buffered lidocaine suppository
Urigen Pharmaceuticals, Inc.
3
Painful Bladder Syndrome
& Overactive Bladder
PBS
Severe
overlap
Moderate
OAB
Severe
Pelvic Pain
Pelvic Pain
Mild
Urgency
Frequency
Disease Progression Over Time
OAB & PBS are bladder ailments
OAB & PBS are points on a continuum of bladder disease
Urigen Pharmaceuticals, Inc.
4
Bladder Markets
Painful Bladder
Syndrome
Overactive Bladder
 5.6% of women/2.8% of men
 10.5 million in US & Canada
 6 million New Rx 2006 in US
 70% of Rx for women in US
 3.8 million qualify as severe
 4 million New Rx per Annum
Rosenberg, MT & Hazzard, M J Urology 174:2231-2234
Urigen Pharmaceuticals, Inc.
IMS Spectra 2006
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Disease Symptoms
PBS
OAB
 Lower abdominal Pain
 +/- Incontinence*
 Urinary Urgency
 Urinary Urgency
 Urinary Frequency
 Urinary Frequency
Nocturia
 Nocturia
 urination at night
 urination at night
 disrupted sleep
 disrupted sleep
 Dyspareunia (painful sex)
Urigen Pharmaceuticals, Inc.
*Primary endpoint of OAB trials
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Market Overview
PBS
OAB
Limited Tx Options
Limited Tx Options
 Elmiron®
 Rimso-50
Unmet Patient Needs
 Pain Relief
 Immediacy of Therapy
Unsatisfied Market
 Patients Adrift
 Misdiagnosed
Urigen Pharmaceuticals, Inc.
 Similar Efficacy
 Significant AEs
Unmet Patient Needs
 Urgency
 Frequency
Unsatisfied Market
 50% Drop Out at 6 mo
 90% Drop Out at 12 mo
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Product Overviews
PBS – URG101
OAB – URG301
 Easy to use kit
 Easy to use
 Office Use/CPT Code
 Home use
 Rapid effect
 Rapid effect
 Local delivery
 Local delivery
Urigen Pharmaceuticals, Inc.
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Business Model
 Limit the Physician Audience
 Urologists
 Gynecologists
 Focus the Marketing Effort
 Maximize the Sales Organization
Urigen Pharmaceuticals, Inc.
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