September 2007. Urigen Pharmaceuticals, Inc. 1 Safe Harbor Statement Safe Harbor Statement Under the...
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Transcript of September 2007. Urigen Pharmaceuticals, Inc. 1 Safe Harbor Statement Safe Harbor Statement Under the...
September 2007
Urigen Pharmaceuticals, Inc. 2
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. 3
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
Product Lines
URG101 – Bladder Instillation Solution Proprietary solution of lidocaine & heparin
URG301 – Urethral Suppository Proprietary buffered lidocaine suppository
Current Urological Product Lines
Bladder
Urigen Pharmaceuticals, Inc. 5
Disease Progression Over Time
Severe
Moderate
Mild
Frequency
Urgency
Pelvic Pain
SeverePelvic PainOAB
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. 6
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. 7
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. 8
Market Overview
PBSLimited Tx Options
Elmiron® Rimso-50
Unmet Patient Needs Pain Relief Immediacy of Therapy
Unsatisfied Market Patients Adrift Misdiagnosed
OABLimited 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. 9
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. 10
Business Model
Limit the Physician Audience
Urologists
Gynecologists
Focus the Marketing Effort
Maximize the Sales Organization