WALTHAM, Mass., Jan. 07, 2019 (GLOBE NEWSWIRE) — Radius Health, Inc. (Nasdaq: RDUS), today announced that it has exceeded its 2018 financial guidance with full-year TYMLOS® U.S. net sales surpassing the upper range of $95 to $98 million. Radius closed 2018 with a $235 million cash, cash equivalents and investments balance achieving its year-end guidance to be above $220 million.
“I am very pleased with the continued strong growth trajectory of TYMLOS which reached an exit 40% share in new patients in its first full-year in the U.S. market. 2019 will be a pivotal year for us as we move closer to our goal of U.S. anabolic market leadership and expect to advance our late-stage clinical pipeline of two innovative Phase 3 products, elacestrant and abaloparatide-patch, both with blockbuster potential,” said Jesper Hoeiland, President and Chief Executive Officer of Radius.
Elacestrant’s Phase 3 EMERALD study was initiated in December 2018. It is the first phase 3 study to prospectively evaluate treatment benefit for second- and third-line breast cancer patients following cyclin-dependent kinase (CDK) 4/6 inhibitor therapy as well as prospectively compare outcomes in patients whose tumors harbor estrogen receptor 1 gene (ESR1) mutations.
In 2018, TYMLOS captured on average 20% of the U.S. anabolic osteoporosis market and exited the year with a 27% total U.S. anabolic market share and 40% share of new anabolic patient starts in December. TYMLOS is currently the only promoted anabolic drug in the U.S. market and is consistently increasing its prescriber base.
A 5.9% price increase for TYMLOS took effect on January 1, 2019.
Radius maintains its financial guidance for 2019 and expects full-year TYMLOS U.S. net sales to be between $155 to $175 million and its year-end cash, cash equivalents and investments balance to exceed $100 million.
The Company will present further details at the 37th Annual J.P. Morgan Healthcare Conference on Monday, January 7, 2019 at 1:30 pm PST at the Westin St. Francis Hotel in San Francisco, California. A live webcast of the presentation will be available by visiting the Investors section of Radius’ website at https://ir.radiuspharm.com/events-and-presentations. A replay of the webcast will be archived on Radius’ website for 90 days following the presentation.
About Radius
Radius is a science-driven fully integrated biopharmaceutical company that is committed to developing and commercializing innovative endocrine therapeutics in the areas of osteoporosis and oncology. Radius’ lead product, TYMLOS (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. The Radius clinical pipeline includes an investigational abaloparatide patch for potential use in osteoporosis; the investigational drug elacestrant (RAD1901) for potential use in hormone-receptor positive breast cancer; and the investigational drug RAD140, a non-steroidal, selective androgen receptor modulator (SARM) under investigation for potential use in hormone-receptor positive breast cancer. For more information, please visit www.radiuspharm.com.
About TYMLOS (abaloparatide) injection
TYMLOS (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 history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. Radius also is developing abaloparatide-patch based on 3M Company’s patented Microstructured Transdermal System technology for potential use as a treatment for postmenopausal women with osteoporosis.
About Elacestrant and EMERALD Phase 3 Study
Elacestrant is an investigational oral selective estrogen receptor degrader (SERD). In a Phase 1 study with a heavily pre-treated population (n=40), elacestrant was well-tolerated with the most commonly reported adverse events being low grade nausea and dyspepsia and demonstrated a single agent activity with a 27.3% objective response rate (ORR) and 5.4 months progression-free survival (PFS) as of the study cut-off date (October 30, 2017).
The EMERALD Phase 3 trial is a randomized, open label, active-controlled study evaluating elacestrant as second- or third-line monotherapy in advanced/metastatic ER-positive (ER+)/HER2-negative (HER2-) breast cancer patients. The study will enroll approximately 460 patients who have received prior treatment with one or two lines of endocrine therapy, including a cyclin-dependent kinase (CDK) 4/6 inhibitor. Patients in the study will be randomized to receive either elacestrant or the investigator’s choice of an approved hormonal agent. The primary endpoint of the study will be progression-free survival (PFS) in the overall patient population and in patients with estrogen receptor 1 gene (ESR1) mutations. Secondary endpoints will include evaluation of overall survival (OS), objective response rate (ORR), and duration of response (DOR).
Forward-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, including without limitation statements regarding our financial guidance, including expectations for full-year TYMLOS net sales and our year-end cash, cash equivalents and investments balance; our expectations regarding commercialization of TYMLOS in the U.S., including expectations for capturing a share of the U.S. anabolic osteoporosis market and growth of the anabolic market; our expectation that elacestrant and abaloparatide-patch each have blockbuster potential; our expectations regarding our clinical trials, including the design and timing thereof; the progress in the development of our product candidates, including abaloparatide-patch, elacestrant (RAD1901) and RAD140; and the potential clinical uses and therapeutic and other benefits of our product candidates, including abaloparatide-patch, elacestrant and RAD140.
These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: we expect to need to raise additional funding, which may not be available; risks related to raising additional capital; our limited operating history; quarterly fluctuation in our financial results; our dependence on the success of TYMLOS, and our inability to ensure that TYMLOS will obtain regulatory approval outside the U.S. or be successfully commercialized in any market in which it is approved, including as a result of risk related to coverage, pricing and reimbursement; risks related to competitive products and any collaboration agreements failing to be successful; risks related to clinical trials, including our reliance on third parties to conduct key portions of our clinical trials and uncertainty that results will support our product candidate claims; the risk that adverse side effects will be identified during the development of our product candidates or during commercialization, if approved; risks related to manufacturing, supply and distribution; and the risk of litigation or other challenges regarding our intellectual property rights. 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, 2017 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. Any such forward-looking statements represent management’s estimates as of the date of 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 & Media Relations Contact:
Elhan Webb, CFA
Email: ewebb@radiuspharm.com
Phone: 617-551-4011