Year End 2012 Results
For the year ended December 31, 2012, the company reported a net loss of $139.9 million, or $1.42 per share, compared to a loss of $46.1 million, or $0.55 per share, for the year ended December 31, 2011. The increase was primarily due to higher selling, general and administrative expenses incurred for the commercialization of Qsymia.
Mr. Wilson continued, "We are executing a commercialization strategy focused on driving awareness of Qsymia and the important role it can play in the medical obesity treatment paradigm. There is an addressable patient population in the U.S. of approximately 100 million people, and less than 2% are currently being treated with pharmacotherapy for obesity. We believe that Qsymia can change this dynamic. Qsymia is the first-ever and only FDA-approved oral medication shown to achieve more than 10% average weight loss, and we believe there is a significant opportunity to improve patient care and drive value for our shareholders. Throughout 2013, our strategy is focused on enhancing the infrastructure necessary to support Qsymia's broad distribution and expand reimbursement access."
Note to Investors
As previously announced, VIVUS will hold a conference call and an audio webcast to discuss the fourth quarter and full-year financial results today, February 25, 2013, beginning at 4:30 pm Eastern Time. Investors can listen to this call by dialing 1-877-359-2916 and outside the U.S. (++) 224-357-2386. A webcast replay will be available for 30 days and can be accessed at
Qsymia was approved with a REMS with the goal of informing prescribers and patients of reproductive potential about an increased risk of orofacial clefts in infants exposed to Qsymia during the first trimester of pregnancy, the importance of pregnancy prevention for females of reproductive potential receiving Qsymia, and the need to discontinue Qsymia immediately if pregnancy occurs. The Qsymia REMS program includes a Medication Guide, Healthcare Provider training, distribution through certified home delivery pharmacies, implementation system and a time table for assessments.