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Radius Health (RDUS) Down 4.3% Since Earnings Report: Can It Rebound?
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It has been about a month since the last earnings report for Radius Health, Inc. (RDUS - Free Report) . Shares have lost about 4.3% in that time frame.
Will the recent negative trend continue leading up to its next earnings release, or is RDUS due for a breakout? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at its most recent earnings report in order to get a better handle on the important drivers.
Radius Q4 Loss Wider Than Expected on Higher Expenses
Radius reported a loss of $1.59 per share in the fourth quarter of 2017, wider than the Zacks Consensus Estimate loss of $1.48 and the year-ago quarter loss of $1.22. Increase in general and administrative expenses led to the wider than anticipated net loss year over year.
The company reported sales of Tymlos (abaloparatide) of $7.7 million surpassing the Zacks Consensus Estimate of $6.7 million.
Quarter in Detail
Research and development expenses for the reported quarter were $22.9 million, down 10.5% year over year due to the reduction in R&D expenses associated with the elacestrant projects and the development of Tymlos. Radius Health received FDA approval for Tymlos in April 2017 for the treatment of postmenopausal women with osteoporosis at high risk of fracture and began shipments to wholesalers at the end of May 2017.
Tymlos continues to gain traction with approximately 259 million covered lives and 93% coverage in commercial plans. Tymlos market share reached approximately 32% of new patients starting anabolic therapy (NBRx) and 13% of total prescriptions in the anabolic market.
General and administrative expenses for the reported quarter jumped to $50.7 million from $27.5 million primarily due to personnel, promotional, and consulting expenses related to the launch of Tymlos.
Pipeline Updates
The company is developing two formulations of abaloparatide-SC and abaloparatide-transdermal. A labeling supplement for Tymlos was submitted to the FDA in the fourth quarter with the positive 43-month data from the ACTIVExtend study, which showed continued significant risk reduction in fractures in patients who were transitioned to receive an additional 24 months of bisphosphonate therapy. In January 2018, Radius Health met with the FDA to discuss the regulatory development path for the abaloparatide patch. The FDA agreed that, depending on the study results, a single, randomized, open label, active-controlled, non-inferiority (to abaloparatide-SC) study of up to 500 patients with postmenopausal osteoporosis at high risk of fracture would be sufficient to gain approval for the abaloparatide patch. The primary endpoint in the study will be change in lumbar spine bone mineral density at 12 months. Radius Health expects to initiate this pivotal trial in mid-2019.
Meanwhile, Radius Health’ Marketing Authorisation Application “(MAA”) for Eladynos (abaloparatide-SC) for the treatment of postmenopausal women with osteoporosis in Europe is under review by the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”). The company however suffered a setback when the CHMP issued a second Day-180 List of Outstanding Issues. In December 2017, the CHMP issued a third Day-180 List of Outstanding Issues and informed the company that it intends to refer the MAA to a scientific advisory group for additional advice. The Company expects an opinion from the CHMP regarding the MAA in the first half of 2018. Radius Health and the FDA have also agreed on the design of a clinical trial in men with osteoporosis, which, if successful, will form the basis of an sNDA seeking to expand the use of Tymlos to treat men with osteoporosis at high risk for fracture. The study is expected to be initiated in the first quarter of 2018.
The company also plans to initiate a clinical trial in men with osteoporosis, which, if successful, will form the basis of an sNDA seeking to expand the label to treat men with osteoporosis at high risk for fracture. The study is expected to be initiated in the first quarter of 2018.
Meanwhile, the company presented positive data on elacestrant for breast cancer in December 2017. The FDA also granted Fast Track designation to elacestrant in October 2017.
In February 2018, Radius Health obtained scientific advice from the EMA regarding a potential single-arm monotherapy phase II trial of elacestrant in patients with ER-positive/HER2-negative advanced or metastatic breast cancer. Based on feedback from the EMA and the FDA, the company will conduct a single, randomized, controlled phase II trial of elacestrant as a third-line monotherapy in approximately 300 patients with ER positive/HER2 negative advanced/metastatic breast cancer.
How Have Estimates Been Moving Since Then?
In the past month, investors have witnessed an upward trend in fresh estimates. There have been two revisions higher for the current quarter.
At this time, RDUS has a poor Growth Score of F and a grade with the same score on the momentum front. The stock was also allocated a grade of F on the value side, putting it in the lowest quintile for this investment strategy.
Overall, the stock has an aggregate VGM Score of F. If you aren't focused on one strategy, this score is the one you should be interested in.
Our style scores indicate investors will probably be better served looking elsewhere.
Outlook
Estimates have been trending upward for the stock and the magnitude of these revisions indicates a downward shift. Interestingly, RDUS has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months.
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Radius Health (RDUS) Down 4.3% Since Earnings Report: Can It Rebound?
It has been about a month since the last earnings report for Radius Health, Inc. (RDUS - Free Report) . Shares have lost about 4.3% in that time frame.
Will the recent negative trend continue leading up to its next earnings release, or is RDUS due for a breakout? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at its most recent earnings report in order to get a better handle on the important drivers.
Radius Q4 Loss Wider Than Expected on Higher Expenses
Radius reported a loss of $1.59 per share in the fourth quarter of 2017, wider than the Zacks Consensus Estimate loss of $1.48 and the year-ago quarter loss of $1.22. Increase in general and administrative expenses led to the wider than anticipated net loss year over year.
The company reported sales of Tymlos (abaloparatide) of $7.7 million surpassing the Zacks Consensus Estimate of $6.7 million.
Quarter in Detail
Research and development expenses for the reported quarter were $22.9 million, down 10.5% year over year due to the reduction in R&D expenses associated with the elacestrant projects and the development of Tymlos. Radius Health received FDA approval for Tymlos in April 2017 for the treatment of postmenopausal women with osteoporosis at high risk of fracture and began shipments to wholesalers at the end of May 2017.
Tymlos continues to gain traction with approximately 259 million covered lives and 93% coverage in commercial plans. Tymlos market share reached approximately 32% of new patients starting anabolic therapy (NBRx) and 13% of total prescriptions in the anabolic market.
General and administrative expenses for the reported quarter jumped to $50.7 million from $27.5 million primarily due to personnel, promotional, and consulting expenses related to the launch of Tymlos.
Pipeline Updates
The company is developing two formulations of abaloparatide-SC and abaloparatide-transdermal. A labeling supplement for Tymlos was submitted to the FDA in the fourth quarter with the positive 43-month data from the ACTIVExtend study, which showed continued significant risk reduction in fractures in patients who were transitioned to receive an additional 24 months of bisphosphonate therapy. In January 2018, Radius Health met with the FDA to discuss the regulatory development path for the abaloparatide patch. The FDA agreed that, depending on the study results, a single, randomized, open label, active-controlled, non-inferiority (to abaloparatide-SC) study of up to 500 patients with postmenopausal osteoporosis at high risk of fracture would be sufficient to gain approval for the abaloparatide patch. The primary endpoint in the study will be change in lumbar spine bone mineral density at 12 months. Radius Health expects to initiate this pivotal trial in mid-2019.
Meanwhile, Radius Health’ Marketing Authorisation Application “(MAA”) for Eladynos (abaloparatide-SC) for the treatment of postmenopausal women with osteoporosis in Europe is under review by the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”). The company however suffered a setback when the CHMP issued a second Day-180 List of Outstanding Issues. In December 2017, the CHMP issued a third Day-180 List of Outstanding Issues and informed the company that it intends to refer the MAA to a scientific advisory group for additional advice. The Company expects an opinion from the CHMP regarding the MAA in the first half of 2018. Radius Health and the FDA have also agreed on the design of a clinical trial in men with osteoporosis, which, if successful, will form the basis of an sNDA seeking to expand the use of Tymlos to treat men with osteoporosis at high risk for fracture. The study is expected to be initiated in the first quarter of 2018.
The company also plans to initiate a clinical trial in men with osteoporosis, which, if successful, will form the basis of an sNDA seeking to expand the label to treat men with osteoporosis at high risk for fracture. The study is expected to be initiated in the first quarter of 2018.
Meanwhile, the company presented positive data on elacestrant for breast cancer in December 2017. The FDA also granted Fast Track designation to elacestrant in October 2017.
In February 2018, Radius Health obtained scientific advice from the EMA regarding a potential single-arm monotherapy phase II trial of elacestrant in patients with ER-positive/HER2-negative advanced or metastatic breast cancer. Based on feedback from the EMA and the FDA, the company will conduct a single, randomized, controlled phase II trial of elacestrant as a third-line monotherapy in approximately 300 patients with ER positive/HER2 negative advanced/metastatic breast cancer.
How Have Estimates Been Moving Since Then?
In the past month, investors have witnessed an upward trend in fresh estimates. There have been two revisions higher for the current quarter.
Radius Health, Inc. Price and Consensus
Radius Health, Inc. Price and Consensus | Radius Health, Inc. Quote
VGM Scores
At this time, RDUS has a poor Growth Score of F and a grade with the same score on the momentum front. The stock was also allocated a grade of F on the value side, putting it in the lowest quintile for this investment strategy.
Overall, the stock has an aggregate VGM Score of F. If you aren't focused on one strategy, this score is the one you should be interested in.
Our style scores indicate investors will probably be better served looking elsewhere.
Outlook
Estimates have been trending upward for the stock and the magnitude of these revisions indicates a downward shift. Interestingly, RDUS has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months.