Full-Year 2019 TYMLOS U.S. net revenue exceeds financial guidance, surpassing
TYMLOS exits 2019 with 52% market share in new patients1, on track for market leadership in 2020.
Radius delivers strong year-end balance sheet with
2020 TYMLOS U.S. net revenue expected to be between
full-year cash burn to be below
Recruitment of three Phase 3 studies expected to complete in 2020, with anticipated read-outs in 2021
“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
For 2020, Radius expects full-year TYMLOS U.S. net revenue to be between
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
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.
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
Radius is a science-driven fully integrated biopharmaceutical company that is committed to developing and commercializing innovative endocrine therapeutics. Radius’ lead product, TYMLOS (abaloparatide) injection, was approved by the
About TYMLOS (abaloparatide) injection
TYMLOS (abaloparatide) injection was approved by the
About Abaloparatide-Patch and wearABLe Phase 3 Study
Abaloparatide-patch was developed in a collaboration between Radius and
About Elacestrant (RAD1901)
Elacestrant is a selective estrogen receptor degrader (SERD), which is being evaluated for potential use as a once daily oral treatment for hormone-receptor positive breast cancer. Elacestrant is currently being investigated for potential use in women with advanced estrogen receptor positive, HER2 negative, breast cancer, the most common form of the disease. Studies completed to date indicate that the compound has the potential for use as a single agent or in combination with other therapies for the treatment of breast cancer.
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 2020 TYMLOS U.S. net revenue and year-end cash burn and our ability to become profitable, including within the timing we project; our unaudited expected fourth quarter and full-year 2019 financial results; our expectations regarding commercialization of TYMLOS in the U.S., including expectations that it will become the leader in the U.S. anabolic osteoporosis market and the timing thereof, and annual growth rates of TYMLOS; our expectations regarding our clinical trials, including the design and timing thereof, and our expectations to report top-line data from our Phase 3 wearABLe trial of abaloparatide-patch in the second half of 2021, to complete enrollment in our Phase 3 EMERALD trial of elacestrant in the third quarter of 2020, and to complete recruitment in abaloparatide in male osteoporosis in 2020; the progress in the development of our product candidates, including abaloparatide-patch, elacestrant (RAD1901) and RAD140; our plans to expand our clinical pipeline in bone health and targeted endocrine diseases; our entry into potential collaborations and partnerships, including the timing thereof, as well as our plans to execute strategic exits of elacestrant and RAD140; our expectations that abaloparatide-patch will be approved and launched, including within the timing we project; 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: the risk that our final fourth quarter and audited full-year 2019 financial results will differ materially from our expected results disclosed in this release, including as a result of the completion of year-end closing procedures or the audit of our financial statements; we may 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 ability to achieve our long-term goals, including our ability to strategically exit our oncology assets and become profitable; 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; risks related to our ability to successfully enter into collaboration or partnership agreements and any executed collaboration or partnership 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
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1 US Anabolic Osteoporosis Market; New Patients to Brand: NBRx PMOT. (Source:
2 Cash, cash equivalents, and investments
Source: Radius Health Inc.