Immunomedics, Inc. (Nasdaq:IMMU), a biopharmaceutical company primarily focused on the development of monoclonal, antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases, today reported financial results for the fourth quarter and fiscal year ended June 30, 2010. The Company also highlighted recent key developments and planned activities for its clinical pipeline.
Fourth Quarter and Fiscal Year 2010 Results
The Company reported revenues of $6.1 million and net income of $0.7 million, or $0.01 per share, for the fourth quarter of fiscal year 2010, which ended June 30, 2010. This compares to revenues of $8.3 million and net income of $0.9 million, or $0.01 per share, for the same period last year. The decrease in revenues this quarter was primarily due to a decrease in revenue from the Company's License and Collaboration Agreement with Nycomed. Increased clinical trial activities resulted in higher research and development expenses this quarter. A lower impairment charge on auction rate securities (ARS), as compared to the same period last year, and reductions in our tax obligations have partially offset the revenue shortfall and increased spending.
For fiscal year 2010, the Company reported revenues of $60.9 million and net income of $37.0 million, or $0.49 per share. This compares to revenues of $30.0 million and net income of $2.3 million, or $0.03 per share, for fiscal year 2009. The increase in revenues this fiscal year was primarily the result of recording license fee revenue of $31.1 million for the UCB Agreement and a $1.0 million increase in NIH grant awards. There was no licensing fee revenue from the UCB Agreement recorded in the last fiscal year. A $2.3 million lower impairment charge and gains on the sales and redemptions of ARS also contributed to the improvement in net income in fiscal 2010.
As of June 30, 2010, the Company had $29.5 million in cash and cash equivalents.
"We are pleased our cash position this quarter has improved with the second milestone payment from Nycomed and the sale of one of our ARS," commented Gerard G. Gorman, Senior Vice President, Finance and Business Development, and Chief Financial Officer. "Increased spending for research and development and clinical trial activities is expected to raise our level of cash expenditure for fiscal year 2011, however, we expect to maintain our cash burn in the range of $20 to $22 million. The Company continues to look for funding alternatives, including out-licensing arrangements, to further clinical developments, including the initiation of a Phase III registration trial of veltuzumab in non-Hodgkin's lymphoma," he added.
Key developments and future planned activities:
- Results from UCB's Phase IIb EMBLEM™ study in patients with lupus were reported by clinical investigators at the EULAR 2010 Annual European Congress of Rheumatology and the 9th International Congress on Systemic Lupus Erythematosus. Data showed that all epratuzumab treatment groups had higher responder rates than placebo with the groups receiving a cumulative dose of 2400mg of epratuzumab produced responder rates twice those of placebo. (For more information, please refer to the Company's press release at www.immunomedics.com/news_pdf/2010_PDF/PR06162010.pdf)
- UCB has announced they will initiate two Phase III clinical trials of epratuzumab in patients with lupus in the second half of calendar year 2010.
- Second milestone payment was received from Nycomed for reaching a clinical milestone related to the rheumatoid arthritis program.
- Nycomed is planning to initiate a Phase II study of the subcutaneous formulation of veltuzumab in patients with rheumatoid arthritis during the second half of calendar year 2010.
- Updated results from the ongoing Phase Ib/II study of fractionated yttrium-90-labeled clivatuzumab tetraxetan in combination with gemcitabine for patients with inoperable, advanced pancreatic cancer were presented at the 2010 American Society of Clinical Oncology Annual Meeting. (Please refer to the Company's press release at www.immunomedics.com/news_pdf/2010_PDF/PR06072010.pdf for more information)
- The first clinical trial of the doxorubicin-conjugated milatuzumab is currently enrolling patients with multiple myeloma.
- The Company received an additional patent protection that covers any humanized antibodies that compete for binding to CD74 with milatuzumab, or bind to the same epitope as milatuzumab.