Urigen Pharmaceuticals, Inc. 1 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 Urigens 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. 2 Specialty pharmaceutical company targeting urological disorders 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 Commercialization Strategy
Urigen Pharmaceuticals, Inc. 4 Disease Progression Over Time Severe Moderate Mild Frequency Urgency Pelvic Pain Severe Pelvic Pain OAB PBS overlap Painful Bladder Syndrome & Overactive Bladder OAB & PBS are bladder ailments OAB & PBS are points on a continuum of bladder disease
Urigen Pharmaceuticals, Inc. 5 Overactive Bladder 6 million New Rx 2006 in US 70% of Rx for women in US 4 million New Rx per Annum Painful Bladder Syndrome 5.6% of women/2.8% of men 10.5 million in US & Canada 3.8 million qualify as severe Bladder Markets Rosenberg, MT & Hazzard, M J Urology 174:2231-2234 IMS Spectra 2006
Urigen Pharmaceuticals, Inc. 6 Disease Symptoms PBS Lower abdominal Pain Urinary Urgency Urinary Frequency Nocturia urination at night disrupted sleep Dyspareunia (painful sex) OAB +/- Incontinence* Urinary Urgency Urinary Frequency Nocturia urination at night disrupted sleep *Primary endpoint of OAB trials
Urigen Pharmaceuticals, Inc. 7 Market Overview PBS Limited Tx Options Elmiron® Rimso-50 Unmet Patient Needs Pain Relief Immediacy of Therapy Unsatisfied Market Patients Adrift Misdiagnosed OAB Limited Tx Options Similar Efficacy Significant AEs Unmet Patient Needs Urgency Frequency Unsatisfied Market 50% Drop Out at 6 mo 90% Drop Out at 12 mo
Urigen Pharmaceuticals, Inc. 8 Product Overviews PBS – URG101 Easy to use kit Office Use/CPT Code Rapid effect Local delivery OAB – URG301 Easy to use Home use Rapid effect Local delivery
Urigen Pharmaceuticals, Inc. 9 Business Model Limit the Physician Audience Urologists Gynecologists Focus the Marketing Effort Maximize the Sales Organization