XenoPort, Inc. (Nasdaq: XNPT) announced today its financial results for the fourth quarter and year ended December 31, 2012. Revenues for the quarter were $0.5 million, compared to $5.4 million for the same period in 2011. Net income for the fourth quarter was $3.0 million, which resulted from a non-cash gain on XenoPort’s litigation settlement with Glaxo Group Limited (GSK), compared to a net loss of $16.9 million for the same period in 2011. At December 31, 2012, XenoPort had cash and cash equivalents and short-term investments of $139.0 million.
XenoPort Business Updates
Since the beginning of the fourth quarter of 2012:
- XenoPort and GSK announced that they had terminated their collaboration agreement concerning Horizant® (gabapentin enacarbil) Extended-Release Tablets under which GSK held commercialization rights and certain development rights in the United States. The termination and transition agreement also released all claims and resolved all pending litigation between the parties. During a transition period that will end on April 30, 2013, GSK will continue to exclusively commercialize, promote, manufacture and distribute Horizant in the United States. Following the transition period, XenoPort will assume all responsibilities for the further development, manufacturing and commercialization of Horizant in the United States.
- As part of the termination and settlement, GSK purchased $40.0 million of common stock of XenoPort, or 4,031,212 shares at an average price of $9.923 per share. Such shares were purchased in two tranches at a 12.5% premium to the average of the closing price of XenoPort common stock during a ten-trading-day period prior to each tranche.
- XenoPort completed enrollment in its Phase 3 pivotal trial of arbaclofen placarbil (AP) as a potential treatment for spasticity in patients with multiple sclerosis (MS).
- XenoPort announced favorable preliminary results from a Phase 1 clinical trial in healthy adults designed to assess the pharmacokinetics (PK), safety and tolerability of single doses of four different oral formulations of XP23829, a novel fumaric acid ester compound that is a prodrug of monomethyl fumarate (MMF). The trial demonstrated that administration of XP23829 resulted in the expected levels of MMF in the blood. XP23829 was generally well-tolerated in the trial.
- XenoPort initiated a Phase 1, multiple ascending dose clinical trial of XP23829 designed to determine the safety and steady-state PK profile of XP23829 in once-per-day and twice-per-day formulations.
- XenoPort also initiated a Phase 1 radiolabeled XP23829 clinical trial in healthy subjects designed to establish the metabolism and disposition of XP23829.
Ronald W. Barrett, Ph.D., chief executive officer of XenoPort, stated, “The reacquisition of Horizant represents an exciting opportunity for XenoPort and will mark the transition of the company into a commercial entity. We look forward to educating key stakeholders about the benefits and risks of Horizant starting May 1. We are working to finalize a focused commercial plan intended to grow the Horizant business in a cost efficient manner while maintaining flexibility to potentially expand our commercial efforts. Meanwhile, we are awaiting our Phase 3 AP clinical trial results in the second quarter. Assuming positive results, we would target the submission of a New Drug Application (NDA) in the United States for AP for the treatment of spasticity for patients with MS or spinal cord injury by the end of this year.”Dr. Barrett continued, “We are equally excited about our progress on XP23829. Our first clinical trial provided the type of positive results we expected, and we are looking forward to receiving the results of two additional Phase 1 trials and of 13-week toxicology studies by mid-year. With these data in hand, we hope to speak to regulatory authorities about potential development paths in several indications, including relapsing-remitting multiple sclerosis (RRMS) and psoriasis. We are looking forward to reporting our progress later in 2013.”