The net loss for 2012 was $0.5 million, or $0.03 per share, compared with net income for 2011 of $9.7 million, or $0.49 per share. Net income for 2011 included a $13.3 million income tax benefit. Excluding the increase in liability for contingent value rights of $1.7 million, or $0.08 per share, for 2012 and $1.0 million, or $0.05 per share, for 2011, net income for 2012 was $1.1 million, or $0.06 per share, compared with net income for 2011 of $10.7 million, or $0.55 per share.The loss from continuing operations for 2012 was $2.7 million, or $0.13 per share, compared with income from continuing operations for 2011 of $9.7 million, or $0.49 per share. Excluding the increase in liability for contingent value rights of $1.7 million, or $0.08 per share, for 2012 and an increase in liability for contingent value rights of $1.0 million, or $0.05 per share, for 2011, the loss from continuing operations for 2012 was $1.0 million, or $0.05 per share, compared with income from continuing operations for 2011 of $10.7 million, or $0.55 per share. 2013 Operating Forecast For 2013 Ligand expects total revenues to be in the range of $41 million to $44 million and combined research and development and general and administrative expenses to be approximately $27 million, including approximately $7 million of non-cash expense items. Net income per share for 2013 is expected to be in the range of $0.35 to $0.39. Fourth Quarter and Recent Business Highlights
- Ligand partner GlaxoSmithKline announced that the FDA approved Promacta for the treatment of thrombocytopenia (low blood platelet counts) in patients with chronic hepatitis C to allow them to initiate and maintain interferon-based therapy. Promacta is the first supportive care treatment available to patients who are ineligible or poor candidates for interferon-based therapy due to low blood platelet counts. Promacta in combination with interferon-based therapy has been shown to improve a patient’s ability to achieve sustained virologic response or viral cure.
- GlaxoSmithKline received marketing approval for Promacta for the treatment of chronic idiopathic thrombocytopenia in Bangladesh. Promacta is now approved for sale in 92 countries worldwide.
- Ligand initiated a pivotal trial of Captisol-enabled, propylene glycol-free (PG-free) high-dose melphalan as a conditioning treatment prior to autologous stem cell transplant for patients with multiple myeloma. This multi-center trial will evaluate safety and efficacy in 60 patients, and is intended to confirm the results from an earlier Phase 2a study demonstrating that the PG-free melphalan intravenous formulation was safe and well-tolerated, and met the requirements for establishment of bioequivalence to the current commercial intravenous formulation of melphalan (sold by GlaxoSmithKline as Alkeran ® for Injection).
- Ligand partner Pfizer announced that the FDA accepted for review a New Drug Application (NDA) for bazedoxifene/conjugated estrogens (BZA/CE), a potential new medicine for non-hysterectomized women for the treatment of moderate-to-severe vasomotor symptoms and vulvar and vaginal atrophy associated with menopause, as well as the prevention of postmenopausal osteoporosis. The FDA Prescription Drug User Fee Act (PDUFA) date is October 3, 2013.
- Ligand presented preclinical data on LG-7501 at the 63 rd Annual Meeting of the American Association for the Study of Liver Diseases. LG-7501 is a small molecule inhibitor of NS5B polymerase for the treatment of hepatitis C virus infection, which uses Ligand’s HepDirect™ liver-targeting technology platform.
- Ligand received a milestone payment of 620,000 shares of common stock in partner Retrophin, Inc., valued at approximately $1.4 million as of the transaction date and as of December 31, 2012, under the previously executed license agreement for the development and commercialization of Retrophin’s lead clinical candidate RE-021, formerly known as DARA (a Dual Acting Receptor Antagonist of Angiotensin and Endothelin receptors). Receipt of this milestone was triggered by the completion of Retrophin’s merger with Desert Gateway, Inc. and its transition to a publicly traded company.
- Investigators reported additional data from Ligand’s successfully completed Phase 2a study of Captisol-enabled, PG-free melphalan, which will be presented this evening in a poster session at the 2013 BMT Tandem Meetings Conference in Salt Lake City.