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Business Overview and Basis of Presentation
9 Months Ended
Mar. 31, 2018
Business Overview and Basis of Presentation  
Business Overview and Basis of Presentation

1.Business Overview and Basis of Presentation

Immunomedics is a clinical-stage biopharmaceutical company that develops monoclonal antibody-based products for the targeted treatment of cancer and other serious diseases. Our corporate objective is to become a fully-integrated biopharmaceutical company and a leader in the field of antibody-drug conjugates (“ADCs”). To that end, our immediate priority is to commercialize our most advanced ADC product candidate, sacituzumab govitecan (“IMMU-132”), beginning in the U.S., with metastatic triple-negative breast cancer (“mTNBC”) as the first indication.  We plan to submit a Biologics License Application (“BLA”) to the United States Food and Drug Administration (“FDA”) by the end of May 2018 for accelerated approval of sacituzumab govitecan for the treatment of patients with mTNBC who have received at least two prior therapies for metastatic disease.

The Company has two foreign subsidiaries, Immunomedics B.V. in the Netherlands and Immunomedics GmbH in Rodermark, Germany, that assist the Company in clinical trials in Europe.  The accompanying condensed financial statements include results for its two foreign subsidiaries and its majority-owned U.S. subsidiary, IBC Pharmaceuticals, Inc. (“IBC”).

The accompanying unaudited condensed consolidated financial statements of Immunomedics, which incorporate our subsidiaries, have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”), for interim financial information and the instructions to the Quarterly Report on Form 10‑Q and Regulation S‑X. Accordingly, the statements do not include all of the information and footnotes required by GAAP for complete annual financial statements. With respect to the financial information for the interim periods included in this Quarterly Report on Form 10-Q, which is unaudited, management believes that all adjustments (consisting of normal recurring accruals), considered necessary for a fair presentation of the results for such interim periods have been included. Operating results for the three-month period ended March 31, 2018 are not necessarily indicative of the results that may be expected for the full fiscal year ending June 30, 2018, or any other period.

Immunomedics is subject to significant risks and uncertainties, including, without limitation, the Company’s inability 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 secure regulatory approval of and market its drug candidates; the development or regulatory approval of competing products; the Company’s 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. Historically, sources of revenue have included sales of LeukoScan®, grants, and license fees and other revenue, however, in order to focus on its ADC business, the Company discontinued the sale of LeukoScan® during February 2018.

As of March 31, 2018 the Company had $358.8 million in cash, cash equivalents and marketable securities. On January 8, 2018, the Company announced that it had agreed to sell tiered, sales-based royalty rights on global net sales of sacituzumab govitecan to RPI Finance Trust (“RPI”) for $175.0 million. RPI also purchased $75.0 million in common stock of Immunomedics, at $17.15 per share, which represented a more than 15% premium over the stock’s 15-day trailing average closing price at that time. The total $250.0 million funding included in its cash balance as of March 31, 2018, provided Immunomedics with the resources required to support the Company’s next phase of growth as it focuses on developing sacituzumab govitecan in mTNBC, advanced urothelial cancer and other indications of high medical need and on further building its clinical, medical affairs, commercial and manufacturing infrastructure and to fund operations into 2020. During that time the Company plans to file a BLA with the FDA for accelerated approval of sacituzumab govitecan for patients with mTNBC in the U.S., to continue manufacturing sacituzumab govitecan at a large scale to prepare for and supply commercial operations in the U.S., to continue the Phase 3 ASCENT trial of sacituzumab govitecan for mTNBC patients, to invest in further clinical development of sacituzumab govitecan and other pipeline assets, and to launch sacituzumab govitecan as a commercial product in the U.S. initially as a treatment for patients with mTNBC who have received at least two prior therapies for metastatic disease.

 

The Company will require additional funding in 2020 to complete its clinical trials currently underway or planned, to continue research and new development programs, to expand commercial applications for sacituzumab govitecan into earlier lines of therapy for mTNBC patients and for patients with other types of cancer indications, such as advanced urothelial cancer and other indications with high, unmet medical need, as a mono and combination therapy, and to continue operations. Potential sources of funding include the exercise of outstanding warrants, the entrance into various potential strategic partnerships towards advancing and maximizing the Company’s full pipeline for mTNBC and beyond, the sales and marketing of sacituzumab govitecan as a third-line therapy for mTNBC in the U.S. (pending the submission of the BLA and FDA’s approval), and potential equity and debt financing.

The Company expects to continue to fund its operations with its current financial resources. In order to meet its cash needs, the Company may also enter into various potential strategic partnerships towards advancing and maximizing the Company’s full pipeline for mTNBC and beyond, or the sales and marketing of sacituzumab govitecan as a third-line therapy for mTNBC in the U.S. (pending the submission of the BLA and FDA’s approval). In 2020, if the Company cannot obtain sufficient funding, 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. The Company’s existing debt may also negatively impact the Company’s ability to raise additional capital. If the Company is unable to raise capital on acceptable terms, its ability to continue its business would be materially and adversely affected.