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Business Overview
12 Months Ended
Jun. 30, 2016
Business Overview [Abstract]  
Business Overview

 

IMMUNOMEDICS, INC. AND SUBSIDIARIES

Notes to Consolidated Financial Statements

1.     Business Overview

Immunomedics, Inc., a Delaware corporation (“Immunomedics” or the “Company”) is a clinical-stage biopharmaceutical company developing monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases. The Company has continued to transition its focus away from the development and commercialization of diagnostic imaging products in order to accelerate the development of its therapeutic product candidates, although the Company manufactures and commercializes its one product, LeukoScan®, in territories where regulatory approvals have previously been granted in Europe, Canada and in certain other markets outside the U.S. LeukoScan® is indicated for diagnostic imaging for determining the location and extent of infection/inflammation in bone in patients with suspected osteomyelitis, including patients with diabetic foot ulcers.

The Company has two foreign subsidiaries, Immunomedics B.V. in the Netherlands and Immunomedics GmbH in Darmstadt, Germany, to assist the Company in managing sales efforts and coordinating clinical trials in Europe. In addition, included in the accompanying financial statements is the majority-owned U.S. subsidiary, IBC Pharmaceuticals, Inc. (“IBC”), which has been working since 1999 on the development of novel cancer radiotherapeutics using patented pretargeting technologies with proprietary, bispecific antibodies.

Immunomedics is subject to significant risks and uncertainties, including, without limitation, the risk that the Company may be unable to further identify, develop and achieve commercial success for new products and technologies; the possibility of delays in the research and development necessary to select drug development candidates and delays in clinical trials; the risk that clinical trials may not result in marketable products; the risk that the Company may be unable to successfully finance and secure regulatory approval of and market its drug candidates; its dependence upon pharmaceutical and biotechnology collaborations; the levels and timing of payments under its collaborative agreements; uncertainties about the Company’s ability to obtain new corporate collaborations and acquire new technologies on satisfactory terms, if at all; the development of competing products; its ability to protect its proprietary technologies; patent-infringement claims; and risks of new, changing and competitive technologies and regulations in the United States and internationally.

Since its inception in 1982, Immunomedics’ principal sources of funds have been the private and public sale of equity and debt securities and revenues from licensing agreements, including up-front and milestone payments, funding of development programs, and other forms of funding from collaborations. As of June 30, 2016 the Company has $50.6 million of cash, cash equivalents and marketable securities., During fiscal 2017, the Company plans to continue Phase 2 clinical trials of sacituzumab govitecan in patients with metastatic triple negative breast cancer (TNBC), metastatic non-small-cell lung cancer (NSCLC), small-cell lung cancer (SCLC), and metastatic urothelial cancers. The Company’s research and development activities also include preparations to conduct the Phase 3 clinical trial in TNBC and preparation to demonstrate readiness to manufacture sacituzumab govitecan commercially. Based on the Company’s cash flow projections, it believes it has sufficient funds to continue its operations and research and development programs for at least the next twelve months.

Although the Company has sufficient funding to continue its Phase 2 clinical programs, prepare for the Phase 3 clinical trial and prepare for commercial manufacturing of sacituzumab govitecan, it will require additional funding in order to initiate the Phase 3 clinical trial in TNBC in fiscal 2017, and to complete commercial manufacturing readiness of sacituzumab govitecan. Furthermore, the Company will require additional funding beyond fiscal 2017 to complete its clinical trials currently underway or planned, continue research and new development programs, and continue operations. To fund its business plan, the Company continues to pursue potential strategic licensing or collaboration agreements as a possible source of financing. These business arrangements may be with new or existing partners and may include the Company’s clinical development programs as well as any of its intellectual property estate. Other potential sources of financing include equity and potential debt financing.

Until the Company can generate significant cash through strategic licensing or collaboration agreements, it expects to continue to fund its operations with the financial resources it currently possesses. These financial resources may not be adequate to sustain the Company’s operations. Consequently, if the Company cannot obtain sufficient funding through strategic licensing or collaborations, it could be required to finance future cash needs through the sale of additional equity and/or debt securities in capital markets.  However, there can be no assurance that the Company will be able to raise the additional capital needed to complete its pipeline of research and development programs on commercially acceptable terms, if at all. The capital markets have experienced volatility in recent years, which has resulted in uncertainty with respect to availability of capital and hence the timing to meet an entity’s liquidity needs. If the Company is unable to raise capital on acceptable terms, its ability to continue its business would be materially and adversely affected. Having insufficient funds may require the Company to delay, scale-back, or eliminate some or all of its programs, or renegotiate less favorable terms than it would otherwise choose. Failure to obtain adequate financing also may adversely affect the Company’s ability to operate as a going concern.