The stock has reached a new 52 week high following coverage from Leerink Swann, initiating an outperform rating and a $6 fair value estimate in 12 months.
Research Coverage:Leerlink Swann (http://www.leerink.com/equity-research.aspx) Excerpt:
"We estimate there are 1.5MM women with HSDD due to surgically induced menopause and 5MM naturally postmenopausal women with HSDD. According to the Centers for Disease Control (CDC), ~500,000 women in the U.S. undergo oophorectomy per year, adding to a pool of ~10MM women without ovaries, 15% of which have HSDD, according to specialists we spoke to. Similarly, we estimate that 10% of the ~50MM naturally postmenopausal women above the age of 50 have HSDD.
Competitive landscape favorable, with no other product candidates in Phase III. There is no pharmaceutical product currently approved in the U.S. for FSD, specifically HSDD, and we are not aware of any other product for the treatment of HSDD in active Phase III clinical development in the U.S."
The report also made the following valuation on BPAX
"We estimate a ~$6 per share fair value for BPAX in 12 months representing a $740MM market capitalization, using a discounted cash flow (DCF) valuation methodology. We use a 12% WACC as our discount rate since the risks involved with drug development and regulatory approval have been handicapped by probability-weighting our free-cash-flow assumptions. We assume an 80% probability of BPAX obtaining approval for LibiGel with the HSDD in surgically menopausal women label and a 70% probability to obtain approval with the HSDD in naturally menopausal women label with patent expiration in 2026. Our per share valuation is based on the fully diluted share count, and accounts for currently outstanding options to purchase 5.4MM shares of common stock, and warrants to purchase 23.7MM shares of common stock."
More info on Leerlink Swann: http://www.leerink.com/equity-research.aspx
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel ® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment (SPA). BioSante's first FDA-approved product is Elestrin™ (estradiol gel) indicated for the treatment of hot flashes associated with menopause, marketed in the U.S. by Azur Pharma, BioSante's licensee. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other BioSante products are Bio-T-Gel™, a testosterone gel for male hypogonadism, for which an NDA is pending, licensed to Teva Pharmaceuticals, and an oral contraceptive in Phase II clinical development using BioSante patented technology. Additional information is available online at: www.biosantepharma.com.
The research report and note are property of the sponsoring investment firm, not BioSante, and contain opinions, conclusions and/or forecasts that are not necessarily those of BioSante. BioSante does not in any way endorse or ratify the contents contained in the report and note.
This article may contain forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include statements about BioSante's plans, objectives, expectations and intentions with respect to future operations and products, future market acceptance, size and potential of LibiGel and other statements identified by words such as "will," "potential," "could," "would," "can," "believe," "intends," "continue," "plans," "expects," "anticipates," "estimates," "may," other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. All forward-looking statements in this presentation speak only as of the date of this presentation. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Contact BioSante:
For info about BioSante Pharmaceuticals, Inc
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
For Media:
McKinney/Chicago
Alan Zachary
(312) 506-5220
azachary@mckinneychicago.com
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