Radius Health, Inc.: Progress Since May 2020

Completed enrollment in 3 pivotal clinical trials; multiple data read outs in Q4 2021
Released meaningful abaloparatide histomorphometry data at recent ASBMR meetingCompleted two business development transactions with existing oncology assetsRepositioned commercial effort to focus on high risk/fracture patient segmentIncreased current operating leverage by re-engineering components of infrastructure
WALTHAM, Mass., Oct. 21, 2020 (GLOBE NEWSWIRE) — Radius Health, Inc. (“Radius” or the “Company”) (Nasdaq: RDUS) 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:Business DevelopmentUS TYMLOS Commercial BusinessIncreasing Current Operating Leverage:Real estate goal: reduce from ~ 60,000 to ~ 12,000 sq. ft. actioning a hybrid work modelReduced silos at the senior level: consolidated commercial; integrated human resources, information technology, compliance, legal, QA, supply chain and real estateTotal 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 (s)Net new patient numbers for Radius: September and October demonstrating growth from mid-year COVID-19 slow downAbout TYMLOS (abaloparatide) injectionTYMLOS^® (abaloparatide) injection was approved by the U.S. Food and Drug Administration for the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.IMPORTANT SAFETY INFORMATIONWARNING: RISK OF OSTEOSARCOMAAbaloparatide caused a dose-dependent increase in the incidence of osteosarcoma (a malignant bone tumor) in male and female rats. The effect was observed at systemic exposures to abaloparatide ranging from 4 to 28 times the exposure in humans receiving the 80-mcg dose. It is unknown if TYMLOS will cause osteosarcoma in humans.The use of TYMLOS is not recommended in patients at increased risk of osteosarcoma including those with Paget’s disease of bone or unexplained elevations of alkaline phosphatase, open epiphyses, bone metastases or skeletal malignancies, hereditary disorders predisposing to osteosarcoma, or prior external beam or implant radiation therapy involving the skeleton.Cumulative use of TYMLOS and parathyroid hormone analogs (e.g., teriparatide) for more than 2 years during a patient’s lifetime is not recommended.
Orthostatic Hypotension: Orthostatic hypotension may occur with TYMLOS, typically within 4 hours of injection. Associated symptoms may include dizziness, palpitations, tachycardia or nausea, and may resolve by having the patient lie down. For the first several doses, TYMLOS should be administered where the patient can sit or lie down if necessary.Hypercalcemia: TYMLOS may cause hypercalcemia. TYMLOS is not recommended in patients with pre-existing hypercalcemia or in patients who have an underlying hypercalcemic disorder, such as primary hyperparathyroidism, because of the possibility of exacerbating hypercalcemia.Hypercalciuria and Urolithiasis: TYMLOS may cause hypercalciuria. It is unknown whether TYMLOS may exacerbate urolithiasis in patients with active or a history of urolithiasis. If active urolithiasis or pre-existing hypercalciuria is suspected, measurement of urinary calcium excretion should be considered.Adverse Reactions: The most common adverse reactions (incidence ≥2%) are hypercalciuria, dizziness, nausea, headache, palpitations, fatigue, upper abdominal pain and vertigo.INDICATIONS AND USAGETYMLOS is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, TYMLOS reduces the risk of vertebral fractures and nonvertebral fractures.Limitations of UseBecause of the unknown relevance of the rodent osteosarcoma findings to humans, cumulative use of TYMLOS and parathyroid hormone analogs (e.g., teriparatide) for more than 2 years during a patient’s lifetime is not recommended.For the TYMLOS prescribing information, including Boxed Warning, please visit www.tymlospi.comForward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements.
These forward-looking statements are based on management’s current expectations. These statements involve known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any expressed or implied by the forward-looking statements. These risks include, but are not limited to, the following: uncertainty regarding the results of regulatory submissions and oversight; success of our commercial operations; success of our clinical trials and preclinical studies; risks related to manufacturing, supply and distribution; success of any collaboration, partnership, license or similar agreements; achievement of milestones; receipt of royalties or other future contingent payments; ability to implement pricing increases. These and other important risks and uncertainties discussed in our filings with the Securities and Exchange Commission, or SEC, including under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ending December 31, 2019 and subsequent filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.Investor Relations Contact:
Elhan Webb, CFA
Email: ewebb@radiuspharm.com
Phone: 617-551-4011