EXHIBIT 99.1
Immunomedics Announces Fiscal 2010 Results
MORRIS PLAINS, N.J., Aug. 26, 2010 (GLOBE NEWSWIRE) -- 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:
Epratuzumab
- 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.
Veltuzumab
- 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.
Clivatuzumab tetraxetan
- 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)
Milatuzumab
- 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.
About Immunomedics
Immunomedics is a New Jersey-based biopharmaceutical company primarily focused on the development of monoclonal, antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases. We have developed a number of advanced proprietary technologies that allow us to create humanized antibodies that can be used either alone in unlabeled or "naked" form, or conjugated with radioactive isotopes, chemotherapeutics, cytokines or toxins, in each case to create highly targeted agents. Using these technologies, we have built a pipeline of therapeutic product candidates that utilize several different mechanisms of action. We also have a majority ownership in IBC Pharmaceuticals, Inc., which is developing a novel Dock-and-Lock (DNL) methodology with us for making fusion proteins and multifunctional antibodies, and a new method of delivering imaging and therapeutic agents selectively to disease, especially different solid cancers (colorectal, lung, pancreas, etc.), by pr oprietary, antibody-based, pretargeting methods. We believe that our portfolio of intellectual property, which includes approximately 150 patents issued in the United States and more than 375 other patents issued worldwide, protects our product candidates and technologies. For additional information on us, please visit our website at www.immunomedics.com. The information on our website does not, however, form a part of this press release.
This release, in addition to historical information, may contain forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. Such statements, including statements regarding clinical trials, out-licensing arrangements (including the timing and amount of contingent payments), forecasts of future operating results, and capital raising activities, involve significant risks and uncertainties and actual results could differ materially from those expressed or implied herein. Factors that could cause such differences include, but are not limited to, risks associated with new product development (including clinical trials outcome and regulatory requirements/actions), our dependence on our licensing partners for the further development of epratuzumab for autoimmune indications and veltuzumab for non-cancer indications, competitive risks to marketed products and availability of required financing and other sources of funds on acceptable terms, if at all, as well as th e risks discussed in the Company's filings with the Securities and Exchange Commission. The Company is not under any obligation, and the Company expressly disclaims any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise.
| IMMUNOMEDICS, INC. |
| Condensed Consolidated Balance Sheets |
| |
| | June 30, | June 30, |
| | 2010 | 2009 |
| ASSETS | | |
| Current Assets: | | |
| Cash and cash equivalents | $ 29,533,230 | $ 27,390,778 |
| Auction rate securities - current | 957,000 | -- |
| Accounts receivable, net of allowance for doubtful accounts | 428,574 | 702,021 |
| Inventory | 534,709 | 232,920 |
| Other receivables | 766,441 | 1,128,835 |
| Prepaid expenses | 449,809 | 375,934 |
| Other current assets | 329,928 | 396,293 |
| | 32,999,691 | 30,226,781 |
| | | |
| Property and equipment, net | 4,327,801 | 5,079,354 |
| Auction rate securities - non current | 8,222,154 | 17,458,349 |
| Value of life insurance policies | 542,463 | 486,428 |
| Other long-term assets | 30,000 | 30,000 |
| | | |
| | $ 46,122,109 | $ 53,280,912 |
| | | |
| LIABILITIES AND STOCKHOLDERS' EQUITY |
| Accounts payable and other accrued expenses | $ 4,424,216 | $ 4,746,286 |
| Deferred revenue - current | -- | 45,685,385 |
| Other liabilities | 979,278 | 872,700 |
| Stockholders' equity | 40,718,615 | 1,976,541 |
| | | |
| | $ 46,122,109 | $ 53,280,912 |
| |
| |
| Condensed Consolidated Statements of Operations |
| |
| | Three Months Ended | Year Ended |
| | June 30, | June 30, |
| | 2010 | 2009 | 2010 | 2009 |
| | | | | |
| Revenues: | | | | |
| Product sales | $ 498,316 | $ 902,141 | $ 3,146,497 | $ 3,538,883 |
| License fee and other revenues | 5,000,000 | 7,272,000 | 55,685,385 | 25,509,000 |
| Research & development | 615,954 | 122,417 | 2,098,460 | 972,883 |
| | | | | |
| Total Revenues | $ 6,114,270 | 8,296,558 | 60,930,342 | 30,020,766 |
| | | | | |
| Costs and Expenses | 6,759,993 | 5,852,666 | 26,997,211 | 27,538,477 |
| | | | | |
| Operating Income (Loss) | (645,723) | 2,443,892 | 33,933,131 | 2,482,289 |
| | | | | |
| Interest and Other Income | 867,972 | (1,436,569) | 1,834,210 | (1,108,982) |
| | | | | |
| Income before Income Tax Benefit (Expense) | 222,249 | 1,007,323 | 35,767,341 | 1,373,307 |
| | | | | |
| Income Tax Benefit (Expense) | 522,298 | (152,628) | 1,228,885 | 900,386 |
| | | | | |
| Net Income | $ 744,547 | $ 854,695 | $ 36,996,226 | $ 2,273,693 |
| | | | | |
| Net Income per Common Share: | | |
| Basic | $ 0.01 | $ 0.01 | $ 0.49 | $ 0.03 |
| Diluted | $ 0.01 | $ 0.01 | $ 0.49 | $ 0.03 |
| | | | | |
| Weighted average number of common shares outstanding: |
| Basic | 75,237,261 | 75,137,831 | 75,200,866 | 75,125,067 |
| Diluted | 75,957,236 | 76,095,546 | 75,994,190 | 76,082,782 |
CONTACT: Immunomedics, Inc.
Dr. Chau Cheng, Director, Investor Relations
& Grant Management
(973) 605-8200, extension 123
ccheng@immunomedics.com