Completed transformation from a biopharmaceutical company with research and development, manufacturing and marketing operations to a biotechnology company focused on advancing the Company’s PEG-SN38 and locked nucleic acid (LNA) research and development programs. Initiated enrollment in a Phase II PEG-SN38 study for patients with metastatic breast cancer. Investigational New Drug application (IND) for the androgen receptor (AR) antagonist was filed and accepted. Entered into collaboration arrangement with the National Cancer Institute for PEG-SN38 and hypoxia-inducible factor-1α (HIF-1α) antagonist programs. Completed a $50.0 million common share repurchase program and initiated a $200.0 million share repurchase program. Awarded a $1.2 million grant as part of the U.S. government’s Qualifying Therapeutic Discovery Projects Program.
2011 Outlook and Goals
In 2011, Enzon will continue to focus on advancing the development of its novel compounds. These efforts will include ongoing enrollment of patients in the PEG-SN38 Phase II studies for colorectal and breast cancer and the Phase I study evaluating PEG-SN38 in pediatric patients with cancer. Enzon also will continue to advance and explore development opportunities for LNA compounds, including the HIF-1α, Survivin and AR antagonists. Enzon’s transitional support activities to the purchaser of the specialty pharmaceutical business are nearing completion. In January 2011, Enzon received notice that the sBLA related to SS Oncaspar had been approved, leading to the receipt of a $5.0 million milestone payment in 2011 from the purchaser of the specialty pharmaceutical business.
Cash and Investments
Total cash reserves, which include cash, cash equivalents, short-term investments, and marketable securities, were $460.1 million as of December 31, 2010, as compared to $199.7 million as of December 31, 2009. The sale of the specialty pharmaceutical business in 2010 was the single largest reason for the rise in cash reserves. The sale contributed approximately $300.0 million of cash, inclusive of the $40.9 million of proceeds related to the sale of in-process research and development. The Company expended approximately $48.0 million during 2010 and $2.0 million during December 2009 to repurchase a combined total of 4.7 million shares of the Company’s outstanding common stock pursuant to a $50.0 million share repurchase plan announced on December 3, 2009. In late December 2010, the Company initiated a $200.0 million common stock repurchase program against which purchases of $0.4 million were made in 2010. Partially offsetting these cash expenditures during 2010, approximately $28.8 million of cash was received as the result of employee exercises of stock options, net of withholding taxes. During 2009, the Company expended approximately $15.6 million to purchase its convertible notes.