2020-10-21 08:46:05 RDUS Radius Recycling
10/21/20 10/2108:46 10/21/2008:46 | Radius Health provides general business update on progress since MayRadius Health provided a general business update on progress made since May 2020. The Company will provide further updates during its third quarter earnings call and at subsequent investor conferences. The key areas of activity included as part of its update are outlined below. Clinical and Regulatory: Patient enrollment completed for 3 Pivotal Phase III trials: ATOM study evaluating abaloparatide injection for potential use in osteoporotic men with high risk of fracture; wearABLe study evaluating the effects on bone mineral density of abaloparatide delivered via a novel transdermal system; EMERALD study for use of elacestrant to treat ER+/HER2- advanced or metastatic breast cancer in men and postmenopausal women. Japan: Pivotal Phase III trial of abaloparatide injection to treat both men and postmenopausal women; Execution success by Radius partner, Teijin Pharma; Achieved primary endpoint: for osteoporotic patients with high risk for fractures; NDA submitted. Europe: Seeking guidance and clarity regarding possible regulatory re-submission; Histomorphometry Phase 2 Study data: Presented at American Society for Bone and Mineral Research in September; Study assessed the early effect of abaloparatide at the tissue level and demonstrated significant increases in bone formation after three months in postmenopausal women with osteoporosis. Business Development: Completed transaction with Menarini Group for Elacestrant, an oral SERD: Menarini licenses global development and commercial rights; Received $30 million as an upfront payment and up to $320 million in additional milestones along with tiered low to mid-teen royalties; Phase 3 development costs to be fully reimbursed by Menarini Group. Completed transaction with Ellipses Pharma for RAD 140, an oral SARM; Ellipses responsible for all clinical development and advancement; Receive low double-digit percentage of future economics received by Ellipses. US TYMLOS Commercial Business: Re-engineering internal operations: Combined market access with sales and marketing under one umbrella; Reduced sales territories from 159 to 109 and sales regions from 19 to 13; Adjusted incentive compensation plan to incentivize growth in PMO patients at high risk for fracture; Performance Measurement; Net new patients on TYMLOS per month vs. 3 month trailing moving average; Total patients and duration of patients on TYMLOS vs. 3 month moving average; No longer focused on anabolic market share as Radius/TYMLOS business driver. Transparency of TYMLOS performance metrics for the marketplace; Communicate Radius net new patients each month, commencing November 2020; Communicate total Radius patients quarterly, starting with Q1, 2021 results; Share avg. Radius patient months on therapy quarterly, starting Q2, 2021 results. Increasing Current Operating Leverage: Real estate goal: reduce from ~ 60,000 to ~ 12,000 sq. ft. actioning a hybrid work model; Reduced silos at the senior level: consolidated commercial; integrated human resources, information technology, compliance, legal, QA, supply chain and real estate; Total FTE headcount reduced from ~ 400 in 2019 to 315 as of Oct. 1, 2020, an absolute reduction of more than 20 %; Capital allocation: adjusting abaloparatide planned clinical programs to focus on growth through patient segmentation and utilizing existing data with precision of message; Net new patient numbers for Radius: September and October demonstrating growth from mid-year COVID-19 slow down. |
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