UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported) November 5, 2014
Immunomedics, Inc.
(Exact name of registrant as specified in its charter)
Delaware | 000-12104 | 61-1009366 |
(State or other jurisdiction of incorporation) |
(Commission File Number) | (IRS Employer Identification No.) |
300 American Road, Morris Plains, New Jersey | 07950 |
(Address of principal executive offices) | (Zip Code) |
Registrant's telephone number, including area code: (973) 605-8200
Not applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
[ ] | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |
[ ] | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |
[ ] | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |
[ ] | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 2.02. Results of Operations and Financial Condition.
On November 5, 2014, Immunomedics, Inc., a Delaware corporation (the "Company"), issued a press release to report the Company's financial results for the quarter ended September 30, 2014. The full text of the press release is attached to this current report on Form 8-K as Exhibit 99.1.*
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
* The information in this Form 8-K shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934 (the "Exchange Act") or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Exhibit No.
Description
99.1
Press Release of Immunomedics, Inc. dated November 5, 2014 reporting its financial results.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Immunomedics, Inc.
(Registrant) |
||
November 5, 2014
(Date) |
/s/ CYNTHIA L. SULLIVAN
Cynthia L. Sullivan President and Chief Executive Officer |
EXHIBIT 99.1
MORRIS PLAINS, N.J., Nov. 5, 2014 (GLOBE NEWSWIRE) -- Immunomedics, Inc., (Nasdaq:IMMU) today reported financial results for the first quarter ended September 30, 2014. The Company also highlighted recent key developments and planned activities for its clinical pipeline.
First Quarter Fiscal 2015 Results
Total revenues for the first quarter of fiscal year 2015, which ended on September 30, 2014, were $1.1 million as compared to total revenues of $5.5 million for the same quarter last fiscal year. The decrease of $4.4 million in total revenues was primarily due to a $4.6 million in license fee revenue earned upon fulfilling the Company's obligations under the Algeta ASA service agreement, as amended, in the previous year. There were no license fee revenues for this fiscal period.
Total costs and expenses for the three-month period ended September 30, 2014 were $13.5 million as compared to $10.7 million for the same period in 2013, representing an increase of $2.8 million or 26%. This increase was primarily attributable to $2.1 million higher legal and professional fees (mainly for the arbitration proceedings), as well as $1.9 million higher research and development expenses for increased activity on the Phase 3 PANCRIT-1 and the Phase 2 antibody-drug conjugates' clinical trials. The increase in cost and expenses this quarter was partially offset by the $1.2 million cost of license fee and other revenue resulting from the recognition of deferred manufacturing costs related to the Algeta service agreement in the fiscal 2014 quarter.
Net loss attributable to our stockholders this quarter was $12.4 million, or $0.13 per share, compared with a net loss attributable to our stockholders of $5.2 million, or $0.06 per share, for the same quarter in fiscal 2014. The $7.2 million increase in net loss this quarter was primarily due to increased legal and professional fees, and higher research and development costs related to clinical trials in the current period, as well as higher net revenue related to the Algeta agreement in the prior period.
The Company has no long-term debt and as of September 30, 2014, cash, cash equivalents and marketable securities totaled $32.0 million. The Company will require additional funding in order to fund its planned Phase 3 and Phase 2 clinical trials in fiscal 2015 and beyond.
"We have a number of significant near-term events that we look forward to, including the presentation by Dr. Goldenberg at the EORTC/NCI/AACR symposium in Barcelona, Spain, on the advancement of our Phase 2 antibody-drug conjugate programs," commented Peter P. Pfreundschuh, Vice President Finance and Chief Financial Officer. "In addition, UCB is sponsoring a number of presentations on epratuzumab in the lupus indication at the American College of Rheumatology annual meeting in Boston," added Mr. Pfreundschuh.
The Company's key clinical developments and future planned activities:
Epratuzumab
Isactuzumab Govitecan (IMMU-132)
Yttrium-90-labeled (90Y) Epratuzumab Tetraxetan
Veltuzumab
Conference Call
The Company will host a conference call and live audio webcast on Thursday, November 6, 2014 at 10:00 a.m. Eastern Time to discuss financial results for the first quarter of fiscal year 2015, and review key clinical developments and future planned activities. To access the conference call, please dial (877) 303-2523 or (253) 237-1755 using the Conference ID 19069282. The conference call will be webcast via the Investors page on the Company's website at www.immunomedics.com. Approximately two hours following the live event, a webcast replay of the conference call will be available on the Company's website for 30 days through December 5, 2014.
About Immunomedics
Immunomedics is a clinical-stage biopharmaceutical company developing monoclonal antibody-based products for the targeted treatment of cancer, autoimmune disorders and other serious diseases. Immunomedics' advanced proprietary technologies allow the Company to create humanized antibodies that can be used either alone in unlabeled or "naked" form, or conjugated with radioactive isotopes, chemotherapeutics, cytokines or toxins. Using these technologies, Immunomedics has built a pipeline of nine clinical-stage product candidates. Immunomedics has an ongoing collaboration with UCB, S.A. (UCB), to whom the Company licensed epratuzumab for the treatment of all non-cancer indications worldwide. UCB expects Phase 3 data in systemic lupus erythematosus in the first half of 2015. Immunomedics is exploring epratuzumab in oncology in collaboration with independent cancer study groups. Immunomedics' most advanced candidate to which it retains worldwide rights for all indications is 90Y-clivatuzumab tetraxetan. The Company initiated a Phase 3 registration trial in January 2014 in patients with advanced pancreatic cancer and expects topline data in mid-2016. Immunomedics' portfolio of wholly owned product candidates also includes antibody-drug conjugates (ADCs) that are designed to deliver a specific payload of a chemotherapeutic directly to the tumor while reducing overall toxic effects that are usually found with conventional administration of these chemotherapeutic agents. Immunomedics' most advanced ADCs are IMMU-132 and IMMU-130, which are in Phase 2 trials for a number of solid tumors and metastatic colorectal cancer, respectively. Immunomedics also has a number of other product candidates that target solid tumors and hematologic malignancies, as well as other diseases, in various stages of clinical and pre-clinical development. These include bispecific antibodies targeting cancers and infectious diseases as T-cell redirecting immunotherapies, as well as bispecific antibodies for next-generation cancer and autoimmune disease therapies, created using its patented DOCK-AND-LOCK® protein conjugation technology. The Company believes that its portfolio of intellectual property, which includes approximately 259 active patents in the United States and more than 400 foreign patents, protects its product candidates and technologies. Immunomedics' strength in intellectual property has resulted in a top-8 ranking in the Biotechnology industry by the Patent Board for the 2014 fiscal year. For additional information on the Company, please visit its website at www.immunomedics.com. The information on its 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 (including the funding therefor, outcomes, timing or associated costs), out-licensing arrangements (including the timing and amount of contingent payments), forecasts of future operating results, potential collaborations, 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, availability of required financing and other sources of funds on acceptable terms, if at all, new product development (including clinical trials outcome and regulatory requirements/actions), our dependence on UCB for the further development of epratuzumab for non-cancer indications, risks associated with the outcome of pending litigation and competitive risks to marketed products, as well as the 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 | ||
September 30, 2014 |
June 30, 2014 |
|
ASSETS | ||
Current Assets: | ||
Cash and cash equivalents | $ 5,445,475 | $ 6,961,494 |
Marketable securities | 26,541,857 | 34,871,120 |
Accounts receivable, net of allowance for doubtful accounts | 555,474 | 674,617 |
Inventory | 732,409 | 778,989 |
Other receivables | 300,647 | 303,102 |
Prepaid expenses | 1,842,922 | 1,614,897 |
Other current assets | 104,603 | 180,678 |
35,523,387 | 45,384,897 | |
Property and equipment, net | 2,086,408 | 1,895,475 |
Value of life insurance policies | 176,110 | 176,110 |
Other long-term assets | 30,000 | 30,000 |
$ 37,815,905 | $ 47,486,482 | |
LIABILITIES AND STOCKHOLDERS' EQUITY | ||
Accounts payable and accrued expenses | $ 9,338,884 | $ 6,886,682 |
Deferred revenues | 243,305 | 240,158 |
Other liabilities | 1,525,123 | 1,500,244 |
Stockholders' equity | 26,708,593 | 38,859,398 |
$ 37,815,905 | $ 47,486,482 | |
Condensed Consolidated Statements of Operations | ||
Three Months Ended September 30, |
||
2014 | 2013 | |
Revenues: | ||
License fee and other revenues | $ -- | $ 4,623,333 |
Product sales | 727,633 | 559,023 |
Research & development | 344,365 | 315,465 |
Total Revenues | 1,071,998 | 5,497,821 |
Costs and Expenses | 13,516,132 | 10,731,166 |
Operating Loss | (12,444,134) | (5,233,345) |
Interest and Other Income | 13,335 | 11,663 |
Loss before Income Tax Expense | (12,430,799) | (5,221,682) |
Income Tax Expense | (11,963) | (4,501) |
Net Loss | (12,442,762) | (5,226,183) |
Less Net Loss attributable on noncontrolling interest | (32,342) | (25,220) |
Net Loss attributable to Immunomedics, Inc. stockholders | $ (12,410,420) | $ (5,200,963) |
Net Loss per Common Share attributable to Immunomedics, Inc. stockholders (basic and diluted): | $ (0.13) | $ (0.06) |
Weighted average number of common shares | ||
outstanding (basic and diluted): | 93,098,202 | 82,947,124 |
CONTACT: For More Information: Dr. Chau Cheng Senior Director, Investor Relations & Grant Management (973) 605-8200, extension 123 ccheng@immunomedics.com