Net loss attributable to our stockholders for the first nine months of fiscal year 2013 was $4.5 million, or $0.06 per basic share, as compared to net income attributable to our stockholders of $8.3 million, or $0.11 per basic share, for the same period in fiscal 2012. The decrease in net income of $12.8 million in the nine months ended March 31, 2013 was primarily due to the non-recurring license fee revenue from the UCB sublicensing amendment in the 2012 period, offset in part by the net proceeds from the FINRA settlement and the business insurance claims in the 2013 period.The Company has no long-term debt and as of March 31, 2013, the Company had $47.8 million of cash and cash equivalents. "The significant cash infusion this quarter has allowed us to continue the development of our diverse pipeline of clinical products, as well as maintain our operations according to plan," commented Gerard G. Gorman, Senior Vice President Finance and Chief Financial Officer. "Clivatuzumab remains our top priority in our clinical pipeline and we look forward to reporting results from the Phase Ib study at upcoming medical conferences," Mr. Gorman added. The Company's key clinical developments and future planned activities: Clivatuzumab tetraxetan
- The Phase Ib trial of 90Y-labeled clivatuzumab tetraxetan has completed enrolling patients with pancreatic cancer who have failed at least two prior therapies.
- Results from this study will be reported in an oral presentation at the 15 th World Congress on Gastrointestinal Cancer organized by the European Society of Medical Oncology in July 2013.
- First results from a Phase I study of labetuzumab-SN-38 in patients with advanced colorectal cancer were presented in a late-breaking poster at the 2013 Annual Meeting of the American Association for Cancer Research. (For more information, please refer to the Company's press release at www.immunomedics.com/pdfs/news/2013/pr04092013.pdf ).
- Updated Phase I results of 90Y-labeled epratuzumab tetraxetan combined with veltuzumab in patients with aggressive lymphoma will be presented at the 2013 Annual Meeting of the Society of Nuclear Medicine & Molecular Imaging ("2013 SNMMI Annual Meeting") on Monday, June 10, 2013.
- At the 2013 SNMMI Annual Meeting, a multicenter, Phase II trial evaluating yttrium-90-labeled epratuzumab tetraxetan given in small fractions as a consolidation therapy after first-line chemotherapy in patients older than 60 with disseminated diffuse large B-cell lymphoma will be updated in an oral presentation.
- During this quarter, Takeda-Nycomed's management approved the strategic decision to pursue clinical development in systemic lupus erythematosis (SLE) as the lead indication with subcutaneous veltuzumab. A Phase II dose range finding trial is under preparation. Applications seeking scientific advice in the EU and a pre-IND meeting request in the US have been filed.
- This decision to proceed with the SLE indication as opposed to the rheumatoid arthritis (RA) indication comes after careful analysis of the current RA market. Takeda-Nycomed believes that the RA market is very competitive, with a CD20-antibody product already approved for use, and with many additional therapeutic options for patients that suffer from RA. Conversely, Takeda-Nycomed believes that the SLE market has fewer therapeutic options for patients that suffer from SLE, and that the SLE market offers greater commercial potential for veltuzumab than the RA market at this time.
- A Phase I study to assess the safety and tolerability of milatuzumab when added to a standard regimen to prevent acute graft-versus-host disease in patients with hematologic malignancies undergoing stem cell transplant is expected to begin patient enrollment before the end of fiscal year 2013.
- A Phase I dose-escalation study of subcutaneously administered IMMU-114, a humanized anti-HLA-DR antibody, as a monotherapy for patients with relapsed or refractory non-Hodgkin's lymphoma and chronic lymphocytic leukemia is planned for the first half of fiscal 2014. An IND for this trial has been accepted by the FDA.
|Condensed Consolidated Balance Sheets|
|March 31, 2013||June 30, 2012|
|Cash and cash equivalents||$ 47,797,686||$ 32,838,096|
|Accounts receivable, net of allowance for doubtful accounts||517,385||659,958|
|Other current assets||183,612||593,900|
|Property and equipment, net||2,175,462||2,527,500|
|Value of life insurance policies||611,138||598,288|
|Other long-term assets||30,000||30,000|
|$ 54,386,416||$ 38,635,221|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Accounts payable, accrued expenses and deferred revenues||$ 9,477,771||$ 5,594,800|
|Other long-term liabilities||1,375,849||1,301,212|
|$ 54,386,416||$ 38,635,221|
|Condensed Consolidated Statements of Operations|
|Three Months Ended||Nine Months Ended|
|March 31,||March 31,|
|License fee and other revenues||$ 126,667||$ --||$ 126,667||$ 28,418,000|
|Research & development||858,182||202,341||1,254,571||660,132|
|Costs and Expenses||10,273,823||8,576,746||27,525,765||23,344,186|
|Operating (Loss) Income||(8,537,357)||(7,606,043)||(23,925,730)||8,426,601|
|Interest and Other Income||16,754,433||91,343||19,358,892||35,462|
|(Loss) Income before Income Tax Expense||8,217,076||(7,514,700)||(4,566,838)||8,462,063|
|Income Tax Expense||19,879||216,714||(19,496)||(220,000)|
|Net (Loss) Income||8,236,955||(7,297,986)||(4,586,334)||8,242,063|
|Less Net Loss attributable on noncontrolling interest||(27,783)||(31,705)||(77,045)||(84,416)|
|Net (Loss) Income attributable to Immunomedics, Inc. stockholders||$ 8,264,738||$ (7,266,281)||$ (4,509,289)||$ 8,326,479|
|Net (Loss) Income per Common Share attributable to Immunomedics, Inc. stockholders:|
|Basic||$ 0.11||$ (0.10)||$ (0.06)||$ 0.11|
|Diluted||$ 0.11||$ (0.10)||$ (0.06)||$ 0.11|
|Weighted average number of common shares|
CONTACT: For More Information: Dr. Chau Cheng Senior Director, Investor Relations & Grant Management (973) 605-8200, extension 123 firstname.lastname@example.org