September 2007. Urigen Pharmaceuticals, Inc. 1 Safe Harbor Statement Safe Harbor Statement Under the...

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September 2007

Transcript of September 2007. Urigen Pharmaceuticals, Inc. 1 Safe Harbor Statement Safe Harbor Statement Under the...

Page 1: September 2007. Urigen Pharmaceuticals, Inc. 1 Safe Harbor Statement Safe Harbor Statement Under the Private Securities Litigation Act of 1995 -- With.

September 2007

Page 2: September 2007. Urigen Pharmaceuticals, Inc. 1 Safe Harbor Statement Safe Harbor Statement Under the Private Securities Litigation Act of 1995 -- With.

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.

Page 3: September 2007. Urigen Pharmaceuticals, Inc. 1 Safe Harbor Statement Safe Harbor Statement Under the Private Securities Litigation Act of 1995 -- With.

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

Page 4: September 2007. Urigen Pharmaceuticals, Inc. 1 Safe Harbor Statement Safe Harbor Statement Under the Private Securities Litigation Act of 1995 -- With.

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

Page 5: September 2007. Urigen Pharmaceuticals, Inc. 1 Safe Harbor Statement Safe Harbor Statement Under the Private Securities Litigation Act of 1995 -- With.

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

Page 6: September 2007. Urigen Pharmaceuticals, Inc. 1 Safe Harbor Statement Safe Harbor Statement Under the Private Securities Litigation Act of 1995 -- With.

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

Page 7: September 2007. Urigen Pharmaceuticals, Inc. 1 Safe Harbor Statement Safe Harbor Statement Under the Private Securities Litigation Act of 1995 -- With.

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

Page 8: September 2007. Urigen Pharmaceuticals, Inc. 1 Safe Harbor Statement Safe Harbor Statement Under the Private Securities Litigation Act of 1995 -- With.

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

Page 9: September 2007. Urigen Pharmaceuticals, Inc. 1 Safe Harbor Statement Safe Harbor Statement Under the Private Securities Litigation Act of 1995 -- With.

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

Page 10: September 2007. Urigen Pharmaceuticals, Inc. 1 Safe Harbor Statement Safe Harbor Statement Under the Private Securities Litigation Act of 1995 -- With.

Urigen Pharmaceuticals, Inc. 10

Business Model

Limit the Physician Audience

Urologists

Gynecologists

Focus the Marketing Effort

Maximize the Sales Organization