On January 13, 2020 Radius Health, Inc. ("Radius" or the "Company") (Nasdaq: RDUS), reported that it has exceeded its 2019 financial guidance with unaudited full-year TYMLOS (abaloparatide) injection U.S. net revenue surpassing the upper range of $172 million (Press release, Radius, JAN 13, 2020, View Source [SID1234553084]). Radius closed 2019 with approximately $160 million cash, cash equivalents and investments balance, achieving its year-end guidance to exceed $130 million. The Company plans to report its complete fourth quarter and audited full-year 2019 financial and operating results in February 2020.
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"I am very pleased with the continued growth of TYMLOS, which has become the preferred treatment for postmenopausal osteoporosis patients starting on anabolic therapy. We are confident that in 2020 we will reach leadership in the U.S. TRx anabolic market and complete the recruitment of our three ongoing Phase 3 studies with abaloparatide-SC in male osteoporosis, abaloparatide-patch and elacestrant," said Jesper Hoeiland, President and Chief Executive Officer of Radius.
TYMLOS exited the year reaching market leadership in new anabolic patient starts with a 52% market share and a 42% total U.S. anabolic market share in December. A 7.9% price increase for TYMLOS took effect on January 1, 2020.
For 2020, Radius expects full-year TYMLOS U.S. net revenue to be between $220 to $235 million and its full-year cash burn to be below $80 million.
Radius’ strategy is to expand the TYMLOS label to include treatment for male osteoporosis, as well as transform the use of anabolic therapy to serve unmet needs of high-risk osteoporosis patients with the development and potential launch of abaloparatide-patch. The Company’s abaloparatide-patch Phase 3 wearABLe study was initiated in August 2019 and is expected to deliver top-line results in the second half of 2021.
The Company’s elacestrant Phase 3 EMERALD study is on track to complete recruitment in the third quarter of this year. Given its refined focus on bone health and targeted endocrine diseases, the Company is evaluating strategic options for its oncology assets to maximize their potential value.
US Anabolic Osteoporosis Market; New Patients to Brand: NBRx PMOT. (Source: IQVIA)
Cash, cash equivalents, and investments
On January 10, 2020, the Company entered into a secured, non-dilutive credit facility for up to an aggregate amount of $95 million, comprised of a term loan of up to $55 million and a $20 million revolving credit facility based on accounts receivable and inventory, with the right, subject to certain conditions, to increase the revolver by $20 million. The credit facility has a maturity date of June 1, 2024. This funding is intended to support pre-launch activities for abaloparatide-patch, evaluation of opportunities in targeted endocrine diseases, and to strengthen the Company’s minimum cash balance towards profitability.
Radius’ major objectives and anticipated business outlook over the next three years (2020 – 2022) include the following:
TYMLOS Revenue > 20% compound annual growth rate;
Financial strength and flexibility to support ongoing business and existing pipeline and achieve profitability;
Top-line data readouts from abaloparatide-SC male osteoporosis, abaloparatide-patch and elacestrant Phase 3 studies;
Potential approval, pre-launch preparation and market launch of abaloparatide-patch;
Strategic exit from oncology; and
Expansion of clinical pipeline in bone health and targeted endocrine diseases.
The Company will present further details at the 38th Annual J.P. Morgan Healthcare Conference on Tuesday, January 14, 2020 at 11:30 a.m. PST at the Westin St. Francis Hotel in San Francisco. A live webcast of the presentation will be available by visiting the Investors section of Radius’ website at View Source A replay of the webcast will be archived on Radius’ website for 90 days following the presentation.