BioSante Pharmaceuticals (BPAX) is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's products include LibiGel (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD), which is in Phase III clinical development according to 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 I and Phase II clinical trials. Other BioSante products are Bio-T-Gel, a testosterone gel for male hypogonadism, for which a New Drug Application (NDA) is pending, licensed to Teva Pharmaceuticals, and an oral contraceptive in Phase II clinical development.
BPAX Investor Highlights
BPAX won U.S. clearance to sell Bio-T-Gel, a testosterone replacement therapy for men. Teva will market Bio-T-Gel for men with low testosterone. BioSante, the original developer of Bio-T-Gel, estimates the market for male testosterone products is more than $1.2 billion in the U.S., where hypogonadism affects as many as 5 million men. BioSante licensed the gel to Teva, the world’s largest generic-drug maker, and will receive milestone payments and royalties when the drug is commercialized.
Announced that the independent Data Monitoring Committee (DMC) has completed the eighth unblinded review of the LibiGel Phase III cardiovascular and breast cancer safety study, which has completed enrollment of subjects. The independent DMC has recommended that the LibiGel safety study should continue as per the FDA-agreed protocol, without modifications.
As of December 31, 2011, BioSante had approximately $57 million in cash and cash equivalents and $20.8 million in principal amount of convertible notes outstanding, due on May 1, 2013. The projected burn rate for 2012 is approximately $2.5 million per month, assuming the LibiGel safety study continues.
BioSante continues to analyze the LibiGel data from the two pivotal Phase III efficacy trials first reported on December 14, 2011. LibiGel is in development for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in postmenopausal women, for which there is no FDA-approved product.
BioSante’s cancer vaccines are in development for the treatment of several different types of cancer including melanoma, pancreatic, breast and prostate cancer. Currently, there are 17 Phase I and Phase II clinical studies ongoing, primarily being conducted at Johns Hopkins Sidney Kimmel Comprehensive Cancer Center in Baltimore, Maryland.
Given Imaging (GIVN) together with its subsidiaries, engages in the development, manufacture, and marketing of diagnostic products for the visualization and detection of gastrointestinal tract disorders. The company provides Given System, a wireless imaging system that uses PillCam capsules for visual examination of the gastrointestinal tract. These PillCam capsules when ingested by patients and move naturally through the gastrointestinal tract, and wirelessly transmitting to a portable recorder, enabling the gastroenterologist to view video, images, and data on a computer workstation.
The company also offers PillCam SB capsule for visualization and detection of abnormalities of the small bowel; PillCam ESO capsule for visualizing the esophageal mucosa; PillCam COLON, a video capsule for patients who have received incomplete colonoscopy; and Agile Patency capsule and system, which is a dissolvable capsule that enables physicians to determine whether there are obstructions or strictures in the gastrointestinal tract that prevent the passage of its PillCam Small Bowel capsule. In addition, it provides data recorder, sensor array, and SensorBelt; and RAPID software that processes the capsule data stored in the data recorder to the visual presentation of data. Further, the company offers non-imaging products, such as Bravo pH monitoring system, a wireless catheter-free pH test for gastro esophageal reflux disease; catheter-based AccuTrac pH and impedance monitoring system, and the Digitrapper pH-only monitoring system; and the ManoScan system that obtains mapping of pressures levels and optionally impedance levels, within organs of the human gastrointestinal tract primarily the esophagus and anorectal organs.
It markets and sells its products through local distributors or representatives, as well as directly primarily in the United States, Australia, Canada, France, Germany, Japan, and Israel.
GIVN Investor Highlights
Fourth Quarter 2011 Revenues Increase 8% to $48.5 Million; Fourth Quarter Non-GAAP and GAAP EPS $0.25 and $0.18, Respectively; Fiscal Year 2011 Revenues Increase 13% to $178.0 Million; 2011 GAAP Net Income Increases 41% to $12 Million, or $0.39 per Share; 2011 Non-GAAP Net Income Increases 2% to $20.1 Million, or $0.65 per Share.
Cash and cash equivalents, short-term investments and marketable securities on December 31, 2011 totaled $105 million. Net cash provided by operating activities in the fourth quarter was $10.1 million.
In January, Given Imaging initiated direct commercial operations in Brazil and established an office in São Paulo. Sales activities will be managed by the leadership team from its key distribution partner in Brazil since 2002.
In November, Given Imaging initiated a pivotal trial for PillCam COLON 2 in Japan intended to support the Company's planned regulatory submission to Japan's Pharmaceuticals and Medical Devices Agency in the middle of 2012.
Announced that approximately 700 patients have been enrolled in the Company's PillCam COLON 2 pivotal trial, and more than 500 patients have ingested PillCam COLON 2 in the trial.
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