MORRIS PLAINS, N.J., Feb. 10, 2014 (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 second quarter ended December 31, 2013. The Company also highlighted recent key developments and planned activities for its clinical pipeline. Second Quarter Fiscal 2014 Results Total revenues for the second quarter of fiscal year 2014, which ended December 31, 2013, were $1.2 million, as compared to total revenues of $0.8 million for the same quarter last fiscal year. The increase of $0.4 million in total revenues this quarter was primarily the result of $0.2 million improvement in LeukoScan sales volume in Europe and $0.2 million higher research and development revenue due to the timing and number of research activities from research grants. Total costs and expenses for the quarter ended December 31, 2013 were $9.8 million, as compared to $8.4 million for the same period in 2013, representing an increase of $1.4 million or 17%. This increase was driven primarily by $0.8 million increased research and development expenses from increased clinical trials and product costs, which include the initiation of the Phase III PANCRIT-1 registration study of yttrium-90-labeled clivatuzumab tetraxetan for the therapy of patients with advanced pancreatic cancer. In addition, general and administrative expenses were $0.3 million higher due primarily to increased legal expenses incurred as part of the arbitration proceedings with Takeda-Nycomed. Net loss attributable to our stockholders this quarter was $8.5 million, or $0.10 per share. This compares to net loss attributable to our stockholders of $5.2 million, or $0.07 per share, for the same quarter in fiscal 2013. The $3.3 million increase in net loss this quarter was primarily due to higher research and development expenses and a reduction in other income as a result of $2.5 million of non-recurring insurance proceeds received in fiscal 2013.
First Half Fiscal 2014 ResultsFor the first half of fiscal year 2014, total revenues were $6.7 million, as compared to total revenues of $1.9 million for the same period last fiscal year. The $4.8 million increase in total revenues this period was primarily due to a $4.6 million in license fee revenue earned upon fulfilling the Company's obligations under the Algeta Service Agreement, as amended. Total costs and expenses for the six-month period ended December 31, 2013 were $20.9 million, as compared to $16.8 million for the same period in 2012, representing an increase of $4.1 million or 24%. This increase was driven primarily by $1.9 million higher research and development expenses mostly from increased manufacturing costs for clinical materials for the antibody-drug conjugate trials, the deferred expense of $1.2 million for the license fee and other revenue related to the Algeta Service Agreement, and approximately $0.5 million of increased legal expenses. Net loss attributable to our stockholders this period was $14.1 million, or $0.17 per share. This compares to net loss attributable to our stockholders of $12.3 million, or $0.16 per share, for the same period last fiscal year. The increase in net loss of $1.8 million this period was primarily due to the $4.1 million increase of costs and expenses, mainly from clinical trial-related research and development activities, which was partially offset by higher license fee revenue in this fiscal period, net of the insurance proceeds received in the previous year. The Company has no long-term debt and as of December 31, 2013, cash, cash equivalents and marketable securities totaled $26.8 million. "We are pleased that the start of our Phase III PANCRIT-1 trial was according to our aggressive schedule and that we continued to make clinical progress with our antibody-drug conjugate programs," commented Peter P. Pfreundschuh, Vice President Finance and Chief Financial Officer. "We expect that funding for this trial will come from revenues related to our business development activities along with other sources of capital," added Mr. Pfreundschuh.
The Company's key clinical developments, product status updates and future planned activities:Clivatuzumab tetraxetan
- The Company has initiated the Phase III PANCRIT-1 registration study of yttrium-90-labeled clivatuzumab tetraxetan in patients with metastatic pancreatic cancer who have received at least two prior therapies, one of which must have been agemcitabine-containing regimen. To learn more about PANCRIT-1, please refer to the Company's press release at http://www.immunomedics.com/pdfs/news/2014/pr01092014.pdf.
- In response to the Statement of Defense and Counterclaims filing by Takeda and Takeda-Nycomed on October 11, 2013 alleging, among other things, that the Company wrongfully terminated the licensing agreement between Nycomed GmbH and Immunomedics for the worldwide rights to veltuzumab, the humanized anti-CD20 antibody, in a subcutaneous formulation for all non-cancer indications and caused Takeda and Takeda-Nycomed to suffer significant damages and delays in developing veltuzumab, the Company filed its own Statement of Defense on November 12, 2013 denying Takeda and Takeda-Nycomed's allegations and contesting Takeda's or Takeda-Nycomed's rights to any relief. An arbitrator was appointed later that month and the parties have since begun negotiating a schedule for the arbitration proceedings. The Company expects the arbitration to continue after veltuzumab has transitioned back to the Company.
- At the 2013 American Society of Hematology Annual Meeting, final results from a Phase I/II study of subcutaneous injections of low-dose veltuzumab in patients with relapsed immune thrombocytopenia were presented. For more information, please refer to the Company's press release at http://www.immunomedics.com/pdfs/news/2013/pr12092013.pdf.
- The antibody-drug conjugate has received orphan drug status from the Office of Orphan Products Development of the U.S. Food and Drug Administration for the treatment of small cell lung cancer. More information can be obtained from the Company's press release at http://www.immunomedics.com/pdfs/news/2013/pr12042013b.pdf.
- The recently completed Phase I trial of IMMU-132 in patients with solid cancers was updated at the 2013 Chemotherapy Foundation Symposium on Innovative Cancer Therapy for Tomorrow, which is jointly organized by the Mount Sinai School of Medicine and the Chemotherapy Foundation, a non-profit organization supporting cancer research, in collaboration with The Tisch Cancer Institute. Please refer to the Company's press release at http://www.immunomedics.com/pdfs/news/2013/pr11082013.pdf for more information.
|Condensed Consolidated Balance Sheets|
|December 31,||June 30,|
|Cash and cash equivalents||$ 6,809,948||$ 41,326,000|
|Accounts receivable, net of allowance for doubtful accounts||716,874||622,830|
|Other current assets||718,991||1,631,172|
|Property and equipment, net||1,986,794||2,086,911|
|Value of life insurance policies||603,332||594,832|
|Other long-term assets||30,000||30,000|
|$ 32,784,822||$ 47,927,353|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Accounts payable and accrued expenses||$ 2,839,480||$ 3,950,866|
|$ 32,784,822||$ 47,927,353|
|Condensed Consolidated Statements of Operations|
|Three Months Ended||Six Months Ended|
|December 31,||December 31,|
|2013||2012 *||2013||2012 *|
|License fee and other revenues||$ --||$ --||$ 4,623,333||$ --|
|Research & development||252,549||78,158||568,014||396,389|
|Total Revenues||$ 1,202,450||812,151||6,700,271||1,863,569|
|Costs and Expenses||9,812,770||8,417,662||20,866,641||16,785,112|
|Interest and Other Income||30,845||2,435,575||42,508||2,604,459|
|Loss before Income Tax Expense||(8,579,475)||(5,169,936)||(14,123,862)||(12,317,084)|
|Income Tax (Benefit) Expense||4,501||(19,706)||--||(39,375)|
|Less Net Loss attributable on noncontrolling interest||(25,220)||(23,330)||(50,419)||(49,262)|
|Net Loss attributable to Immunomedics, Inc. stockholders||$ (8,549,754)||$ (5,166,312)||$ (14,073,443)||$ (12,307,197)|
|Net Loss per Common Share attributable to Immunomedics, Inc. stockholders (basic and diluted):||$ (0.10)||$ (0.07)||$ (0.17)||$ (0.16)|
|Weighted average number of common shares outstanding (basic and diluted):||83,174,835||75,671,088||83,060,980||75,640,663|
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