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): August 19, 2015
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 The 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 August 19, 2015, Immunomedics, Inc., a Delaware corporation (the "Company"), issued a press release to report the Company's financial results for the fiscal year ended and quarter ended June 30, 2015. 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 August 19, 2015 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) |
||
August 19, 2015
(Date) |
/s/ CYNTHIA L. SULLIVAN
Cynthia L. Sullivan President and Chief Executive Officer |
EXHIBIT 99.1
MORRIS PLAINS, N.J., Aug. 19, 2015 (GLOBE NEWSWIRE) -- Immunomedics, Inc. (Nasdaq:IMMU) today reported financial results for the fourth quarter and fiscal year ended June 30, 2015. The Company also highlighted recent key developments and planned activities for its clinical pipeline.
Fourth Quarter Fiscal 2015 Results
Total revenues for the fourth quarter of fiscal year 2015, which ended on June 30, 2015, were $2.4 million as compared to total revenues of $1.2 million for the same quarter last fiscal year. The increase of $1.2 million in total revenues this quarter was primarily due to a $1.0 million license fee revenue earned upon reaching a clinical milestone in the Company's Collaboration Agreement, as amended, with Bayer (formerly Algeta ASA). There was no license fee revenue recorded in the same quarter last fiscal year.
Total costs and expenses for the current quarter were $13.6 million, as compared to $13.1 million for the same period in 2014, representing an increase of $0.5 million, or 4%. This increase was driven primarily by $1.1 million higher research and development expenses from increased clinical trial cost for the Phase 3 PANCRIT-1 registration study of yttrium-90-labeled clivatuzumab tetraxetan for the therapy of patients with advanced pancreatic cancer, and increased product development and manufacturing expenses related to the expansion of clinical studies for the two antibody-drug conjugate (ADC) programs. The increase in research and development expenses was partially offset by $0.4 million decreased general and administrative costs mainly from reduced legal and professional fees.
Interest expense this quarter related to the 4.75% Convertible Senior Notes was $1.4 million, including the amortization of $0.2 million debt issuance costs. There was no interest expense for the same quarter last fiscal year.
Net loss attributable to our stockholders this quarter was $12.4 million, or $0.13 per basic share, compared with a net loss attributable to our stockholders of $11.8 million, or $0.13 per basic share for the same quarter in fiscal 2014. The increase in net loss this quarter was primarily due to the increase in research and development expenses and interest expense, partially offset by the decrease in legal and professional fees, as described above.
Fiscal Year 2015 Results
Total revenues for fiscal year 2015 were $5.7 million as compared to $9.0 million for fiscal year 2014, representing a decrease of $3.3 million or 37%. The decrease in total revenues this fiscal year primarily resulted from $4.6 million of license fee revenue earned from the Bayer Collaboration Agreement during fiscal 2014, which was partially offset by the Agreement's $1.0 million clinical milestone payment in fiscal year 2015.
Total costs and expenses for the fiscal year ended June 30, 2015 were $51.9 million, as compared to $44.6 million for fiscal 2014, representing an increase of $7.3 million, or 16%. This increase was driven primarily by $8.0 million higher research and development expenses from the continuing efforts of the Phase 3 PANCRIT-1 clinical trial in pancreatic cancer and increased clinical trial expenses and manufacturing costs for the ADCs' clinical studies, as well as a $0.9 million increase in legal and professional fees, principally from the arbitration proceedings with Takeda-Nycomed. The increase in cost and expenses this fiscal year was partially offset by the prior year's $1.2 million of cost from the recognition of manufacturing costs related to the Bayer Agreement, which did not recur in the current year.
Interest expense this fiscal year for the Convertible Senior Notes due 2020 was $2.1 million, including the amortization of $0.3 million debt issuance costs. There was no interest expense last fiscal year.
Net loss attributable to our stockholders for the fiscal year ended June 30, 2015 was $48.0 million, or $0.51 per basic share, as compared to net loss attributable to our stockholders of $35.4 million, or $0.42 per basic share, in fiscal year 2014. The increase in net loss of $12.6 million this fiscal year was primarily due to increased research and development costs attributable to clinical trials, increased legal and professional fees, interest expense, and lower license fee revenue from Bayer.
As of June 30, 2015, cash, cash equivalents, and marketable securities totaled $99.6 million.
"We are pleased to have a strong balance sheet to support the development of our clinical pipeline," commented Peter P. Pfreundschuh, Vice President Finance and Chief Financial Officer. "To that end, cash requirements in fiscal year 2016 are expected to be in the range of $52 to $54 million, which include the production of sacituzumab govitecan for a Phase 3 registration trial in metastatic triple-negative breast cancer anticipated in calendar year 2016, the ongoing PANCRIT-1 trial, and interest on the convertible notes," Mr. Pfreundschuh added.
The Company's key clinical developments and future planned activities:
Epratuzumab
Sacituzumab Govitecan (IMMU-132)
Labetuzumab Govitecan (IMMU-130)
Clivatuzumab Tetraxetan
Veltuzumab
Conference Call
The Company will host a conference call and live audio webcast on Thursday, August 20, 2015 at 10:00 a.m. Eastern Time to discuss financial results for the fourth quarter and 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 1629702. 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 September 19, 2015.
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' most advanced candidate is 90Y-clivatuzumab tetraxetan. The radiolabeled antibody is in a Phase 3 registration trial in patients with advanced pancreatic cancer. Immunomedics expects patient enrollment to be completed in calendar year 2016. Immunomedics' portfolio of investigational products 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 sacituzumab govitecan (IMMU-132) and labetuzumab govitecan (IMMU-130), which are in Phase 2 trials for a number of solid tumors and metastatic colorectal cancer, respectively. Immunomedics has licensed epratuzumab to UCB, S.A., (UCB) for the treatment of all autoimmune disease indications worldwide. In oncology, Immunomedics has a research collaboration with Bayer to study epratuzumab as a thorium-227-labeled antibody. Immunomedics has other ongoing collaborations in oncology with independent cancer study groups. The IntreALL Inter-European study group is conducting a large, randomized Phase 3 trial combining epratuzumab with chemotherapy in children with relapsed acute lymphoblastic leukemia at clinical sites in Australia, Europe, and Israel. 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 267 active patents in the United States and more than 400 foreign patents, protects its product candidates and technologies. 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, 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, and availability of required financing and other sources of funds on acceptable terms, if at all, 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 | ||||
June 30, | June 30, | |||
2015 | 2014 | |||
ASSETS | ||||
Current Assets: | ||||
Cash and cash equivalents | $ 13,452,775 | $ 6,961,494 | ||
Marketable securities | 86,165,532 | 34,871,120 | ||
Accounts receivable, net of allowance for doubtful accounts | 345,627 | 674,617 | ||
Inventory | 584,424 | 778,989 | ||
Other receivables | 857,068 | 303,102 | ||
Prepaid expenses | 1,136,103 | 1,614,897 | ||
Other current assets | 945,673 | 180,678 | ||
103,487,202 | 45,384,897 | |||
Property and equipment, net | 2,241,838 | 1,895,475 | ||
Other long-term assets | 50,566 | 206,110 | ||
$ 105,779,606 | $ 47,486,482 | |||
LIABILITIES AND STOCKHOLDERS' (DEFICIT) EQUITY | ||||
Accounts payable and accrued expenses | $ 11,808,223 | $ 6,886,682 | ||
Deferred revenues | 271,667 | 240,158 | ||
Other liabilities | 1,599,760 | 1,500,244 | ||
Convertible senior notes - net | 96,624,577 | -- | ||
Stockholders' (deficit) equity | (4,524,621) | 38,859,398 | ||
$ 105,779,606 | $ 47,486,482 | |||
Condensed Consolidated Statements of Operations | ||||
Three Months Ended | Year Ended | |||
June 30, | June 30, | |||
2015 | 2014 | 2015 | 2014 | |
Revenues: | ||||
License fee and other revenues | $ 1,000,000 | $ -- | $ 1,250,000 | $ 4,623,333 |
Product sales | 465,031 | 706,445 | 2,648,657 | 3,140,604 |
Research & development | 930,573 | 480,548 | 1,754,434 | 1,277,668 |
Total Revenues | $ 2,395,604 | 1,186,993 | 5,653,091 | 9,041,605 |
Costs and Expenses | 13,583,367 | 13,078,990 | 51,872,600 | 44,621,846 |
Operating Loss | (11,187,763) | (11,891,997) | (46,219,509) | (35,580,241) |
Interest (Expense) and Other Income | (1,223,599) | 25,061 | (1,846,233) | 56,854 |
Loss before Income Tax Expense | (12,411,362) | (11,866,936) | (48,065,742) | (35,523,387) |
Income Tax Expense | (16,047) | (6,419) | (58,229) | (7,791) |
Net Loss | (12,427,409) | (11,873,355) | (48,123,971) | (35,531,178) |
Less Net Loss attributable on noncontrolling interest | (26,845) | (26,574) | (121,605) | (105,352) |
Net Loss attributable to Immunomedics, Inc. stockholders | $ (12,400,564) | $ (11,846,781) | $ (48,002,366) | $ (35,425,826) |
Net Loss per Common Share attributable to Immunomedics, Inc. stockholders (basic and diluted): | $ (0.13) | $ (0.13) | $ (0.51) | $ (0.42) |
Weighted average number of common shares outstanding (basic and diluted): | 93,656,814 | 89,084,307 | 93,314,872 | 84,631,567 |
CONTACT: For More Information: Dr. Chau Cheng Senior Director, Investor Relations & Corporate Secretary (973) 605-8200, extension 123 ccheng@immunomedics.com