XML 31 R7.htm IDEA: XBRL DOCUMENT v3.6.0.2
Nature of Business
12 Months Ended
Dec. 31, 2016
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Nature of Business
Nature of Business
Radius Health, Inc. ("Radius" or the "Company") is a science-driven biopharmaceutical company that is committed to developing innovative therapeutics in the areas of osteoporosis, oncology and endocrine diseases. The Company's lead product candidate, the investigational drug abaloparatide for subcutaneous injection ("abaloparatide-SC"), has completed Phase 3 development for potential use in the reduction of fracture risk in women with postmenopausal osteoporosis. Radius' New Drug Application ("NDA"), for abaloparatide-SC is under regulatory review by the U.S. Food and Drug Administration ("FDA"), with a Prescription Drug User Fee Act ("PDUFA") date of March 30, 2017. Radius’ European Marketing Authorisation Application ("MAA") for abaloparatide-SC is under review by the Committee for Medicinal Products for Human Use of the EMA ("CHMP"). The Radius clinical pipeline also includes an investigational abaloparatide transdermal patch ("abaloparatide-TD") for potential use in the treatment of women with postmenopausal osteoporosis and the investigational drug RAD1901 for potential use in the treatment of hormone-driven and/or hormone-resistant breast cancer, as well as for potential use in the treatment of vasomotor symptoms in postmenopausal women. Radius' clinical pipeline includes RAD140, a non-steroidal selective androgen receptor modulator, under investigation for potential use in the treatment of breast cancer.
The Company is subject to the risks associated with emerging companies with a limited operating history, including dependence on key individuals, a developing business model, the necessity of securing regulatory approvals to market its investigational product candidates, market acceptance of the Company's investigational product candidates following receipt of regulatory approval, competition for its investigational product candidates following receipt of regulatory approval, and the continued ability to obtain adequate financing to fund the Company's future operations. The Company has incurred losses and expects to continue to incur additional losses for the foreseeable future. As of December 31, 2016, the Company had an accumulated deficit of $628.6 million, and total cash, cash equivalents and marketable securities of $332.4 million.
Based upon its cash, cash equivalents and marketable securities balance as of December 31, 2016, the Company believes that, prior to the consideration of revenue from the potential future sales of any of its investigational products that may receive regulatory approval or proceeds from partnering and/or collaboration activities, it has sufficient capital to fund its development plans, U.S. commercial scale-up and other operational activities, for not less than twelve months from the date of this filing and into 2018. The Company expects to finance the future development costs of its clinical product portfolio with its existing cash and cash equivalents and marketable securities, or through strategic financing opportunities that could include, but are not limited to collaboration agreements, future offerings of its equity, or the incurrence of debt. However, there is no guarantee that any of these strategic or financing opportunities will be executed or executed on favorable terms, and some could be dilutive to existing stockholders. If the Company fails to obtain additional future capital, it may be unable to complete its planned preclinical studies and clinical trials and obtain approval of certain investigational product candidates from the FDA or foreign regulatory authorities.