BioSante (NASDAQ: BPAX): LibiGel Provides Big Upside Potential
BioSante Pharmaceuticals, Inc. (NASDAQ:
BPAX) is a specialty pharmaceutical company focused on developing products for female sexual health, menopause, contraception, and male testosterone deficiency (hypogonadism). The Company's wholly-owned lead product is LibiGel (transdermal testosterone gel), which is in Phase 3 clinical development by BioSante under dual Special Protocol Assessments (SPAs) for the treatment of female sexual dysfunction (FSD).
On 9/22/09, BioSante and Cell Genesys (NASDAQ: CEGE) announced that they have determined the final exchange ratio will be 0.1828 in connection with the previously announced merger between the companies. If the merger is completed, CEGE shareholders will receive 0.1828 of a share of BPAX common stock for each share of CEGE common stock they hold immediately prior to the effective time of the merger. Each company is scheduled to hold a special meeting of stockholders on 9/30/09 at which time shareholders will be asked to approve the merger, and both companies expect to close the proposed merger promptly after such stockholder approvals have been obtained.
Three key points behind the bullish case for BioSante include:
1.) LibiGel is the only product in active clinical development in the U.S. for the treatment of FSD (specifically HSDD) in menopausal women for which there is no FDA-approved pharmaceutical product today, despite a multitude of choices for men that include well-known products such as Viagra, Levitra and Cialis.
2.) Upon closing the CEGE merger at the end of September, BioSante will have sufficient cash on hand to make its way through a NDA filing (expected during 1H11) for LibiGel while retaining full ownership of the product. In addition, BioSante expects a priority (six-month) review for LibiGel since there is no FDA-approved treatment for FSD / HSDD – resulting in a possible FDA approval and market launch in 2H11.
3.) With a share price that is currently hovering around the $2 level, BioSante is valued at a fraction of the conservative market opportunities in the U.S. market alone for LibiGel. With approximately 60 million fully diluted shares upon closing the CEGE merger, BioSante would be valued at a market cap of $120 compared to estimated peak sales for LibiGel of $600 million (the mid-point of Company guidance and 5X the current market cap) in the U.S. market alone.
It has been determined that CEGE's net cash is $23.8 million and since this amount exceeded the applicable net cash target amount of $22.1 million by $1.7 million, the exchange ratio was adjusted upwards from the previous 0.1615 of a share of BPAX common stock. If the merger is completed, BioSante will issue an aggregate of approximately 20.2 million shares of BPAX common stock to holders of CEGE common stock and current BPAX shareholders will own approximately 62% of the combined company.
The following is a summary of key financial metrics reflecting the combination of BPAX / CEGE: (1) 53.2 million shares of common stock outstanding; (2) 5.7 million warrants outstanding (at an exercise price range of $2-8); (3) 2.9 million options outstanding (with an average exercise price of $2.90); (4) 61.8 million fully diluted shares of common stock; and (5) approximately $35 million in cash post-merger closing (which also reflects $12 million raised in mid-August) versus a cash burn rate of about $1.2 million per month.
In mid-April, BioSante announced the U.S. marketing launch of Elestrin (estradiol gel) by Azur Pharma, which is the Company's licensee in the domestic market.
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