On November 2, 2017 Radius Health, Inc. (“Radius” or the “Company”) (Nasdaq:RDUS), reported its financial results for the third quarter ended September 30, 2017, and provided a business update (Press release, Radius, NOV 2, 2017, View Source [SID1234521524]).
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“It is very encouraging for Radius to see TYMLOS gaining traction in the market,” said Jesper Høiland, President and CEO of Radius. “In addition to our stated goal of gaining market leadership for TYMLOS, we are excited by the positive response to the product by physicians, payors and patients. With the recent capital raise, we are also well funded to start investing in expanding the TYMLOS label and advancing the development of our other therapeutic candidates in the pipeline.”
“TYMLOS is proving itself to be an important treatment for a high unmet medical need, as demonstrated by the continued increase in lives covered through managed care contracts,” said David Snow, Chief Commercial Officer of Radius. “Postmenopausal women with osteoporosis at high risk for fractures deserve to have therapies that safely and effectively reduce that risk, with lower out of pocket costs. Our sales team is achieving strong reach and call frequency and we are continuing to expand payer acceptance while we see anabolic class volume stabilizing.”
TYMLOS (abaloparatide injection)
Third quarter reported sales of TYMLOS in the U.S. (the first full quarter since its launch) were approximately $3.5 million. Radius received FDA approval for TYMLOS on April 28, 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.
In September 2017, Radius presented results from the completed ACTIVExtend study in an abstract titled “Sustained Fracture Risk Reduction with Sequential Abaloparatide/Alendronate: Results of ACTIVExtend” at the ASBMR 2017 Annual Meeting in Denver, Colorado. In ACTIVExtend, patients who had completed 18 months of TYMLOS or placebo in the ACTIVE Phase 3 trial were transitioned to receive 24 additional months of open-label alendronate. Patients who received a sequential therapy of TYMLOS followed by alendronate demonstrated statistically significant fracture risk reductions through 3.5 years. At the 43-month timepoint, the previous TYMLOS-treated patients had a significant 84 percent relative risk reduction (p<0.0001) in the incidence of new vertebral fractures compared with women who received placebo followed by alendronate. Additionally, TYMLOS followed by alendronate demonstrated a 39 percent relative risk reduction in nonvertebral fractures (p=0.038), compared with women who received placebo followed by alendronate.
The Company expects to submit a labeling supplement to the FDA in connection with the ACTIVExtend results by the end of 2017.
Pipeline Updates
Abaloparatide — Subcutaneous (SC)
European MAA
Radius’ European Marketing Authorisation Application (MAA) for abaloparatide-SC for the treatment of postmenopausal women with osteoporosis is under review by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). On July 21, 2017, the CHMP issued a second Day-180 List of Outstanding Issues. Radius is working with the CHMP to address these issues, and discussed preliminary responses with the Rapporteurs in a formal Clarification Meeting. We expect an opinion from the CHMP regarding the MAA prior to the end of 2017.
Male Osteoporosis Trial
We recently gained agreement with the FDA 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 will be a randomized, double-blind, placebo-controlled trial that will enroll approximately 225 men with osteoporosis.
The primary endpoint is change in spine bone mineral density (“BMD”) at 12 months compared with placebo. TYMLOS has demonstrated in previous clinical trials that it increases BMD in postmenopausal women. The study will include specialized high-resolution imaging of bone structure in a subset of the study participants. We expect to initiate the trial in the first quarter of 2018.
Abaloparatide-Transdermal Patch (TD)
We have scheduled a meeting with the FDA in January 2018 to align on a regulatory pathway for a pivotal study (e.g. bioequivalence or BMD) for abaloparatide-TD and we are also discussing manufacturing arrangements with 3M Company related to potential commercial supplies of abaloparatide-TD. We are on track to complete manufacturing scale-up, production, and other required activities needed to initiate a pivotal study. The pharmacokinetic profile of an optimized abaloparatide-TD patch was successfully modified so as to improve comparability to abaloparatide-SC. We believe that the transdermal patch program, if approved, will offer patients who suffer from osteoporosis a convenient alternative.
Elacestrant (RAD1901)
In a meeting to discuss the elacestrant breast cancer development program, the FDA indicated that, depending on the study results, which must demonstrate an improvement over then available therapies, the planned single-arm Phase 2 trial could be considered a pivotal study for accelerated approval as long as a confirmatory study is ongoing by the time of the NDA submission. We will provide further study details when the Phase 2 study is initiated, which we expect will be in early 2018. In October, elacestrant received FDA Fast Track designation supporting a rapid speed to market strategy.
Elacestrant is also being evaluated at low doses as an estrogen receptor ligand for the potential relief of the frequency and severity of moderate to severe hot flashes in postmenopausal women with vasomotor symptoms. We are currently reviewing our elacestrant vasomotor development program and plan to provide an update by the end of 2017.
RAD140
In September 2017, the Company announced that the first patient had been enrolled in the Company’s Phase 1 study of RAD140, a nonsteroidal selective androgen receptor modulator (SARM) undergoing clinical evaluation for the treatment of hormone receptor positive breast cancer. The clinical trial is designed to evaluate the safety and maximum tolerated dose of RAD140 in approximately 40 patients.
Radius Anticipates the Following Milestones
Abaloparatide
Receive Committee for Medicinal Products for Human Use (CHMP) opinion regarding the EMA’s review of the abaloparatide-SC MAA before the end of 2017
Submit a labeling supplement in connection with the ACTIVExtend data to the FDA by 2017 year end
Provide updates on the potential regulatory pathway for an abaloparatide-transdermal patch (TD) pivotal study following a scheduled meeting with the FDA in January 2018 and discussions with 3M Company for potential commercial supplies of abaloparatide-TD
Initiate a male osteoporosis study in the first quarter of 2018
Enter into a partnership for the potential commercialization of abaloparatide-SC outside the US and Japan prior to commercial launch in the European Union
Elacestrant
Initiate Phase 2 single-arm monotherapy clinical trial in metastatic breast cancer patients in early 2018
Complete review of the elacestrant vasomotor development program and provide an update by the end of 2017
RAD140
Continue enrollment in the Phase 1 study
Corporate Update
The Company also announced today that Ansbert Gadicke, M.D., has resigned from the Board of Directors of the Company effective November 8, 2017, after having served on the Board of the Company and its predecessor since 2003. Following Dr. Gadicke’s resignation, the Company expects to reduce the size of the Board from 10 to 9 members.
Radius Expects to Make Presentations at the Following Upcoming Conferences
On December 5-9, 2017, Gary Hattersley, PhD, Chief Scientific Officer, will present at the San Antonio Breast Cancer Symposium and Radius will host one-on-one meetings
On January 8-11, 2018, Jesper Høiland, Radius President and CEO, will present and host one-on-one meetings at the 36th JP Morgan Annual Healthcare Conference in San Francisco
On March 12-14, 2018, Jesper Høiland, Radius President and CEO, will present and host one-on-one meetings at the 38th Cowen Annual Healthcare Conference
Third Quarter 2017 Financial Results
Three Months Ended September 30, 2017
For the three months ended September 30, 2017, Radius reported a net loss of $57.8 million, or $1.31 per share, compared to a net loss of $46.2 million, or $1.07 per share, for the three months ended September 30, 2016.
For the three months ended September 30, 2017, Radius reported TYMLOS net product revenues of about $3.5 million, which reflects the first full quarter of recorded sales. Radius had no revenue in the three months ended September 30, 2016 as the FDA approved TYMLOS on April 28, 2017.
Research and development expense for the three months ended September 30, 2017, was $21.0 million compared to $27.5 million for the three months ended September 30, 2016, a decrease of $6.5 million, or 24%. This decrease was primarily driven by a $3.4 million decrease in vasomotor project related spending, a $2.0 million decrease in abaloparatide-SC project costs, and a $1.1 million decrease in RAD1901 oncology project costs.
Selling, general, and administrative expense for the three months ended September 30, 2017, was $47.7 million compared to $19.2 million for the three months ended September 30, 2016, an increase of $28.5 million, or 148%. This increase was primarily the result of an increase of approximately $10.1 million in professional fees and support costs, including the costs associated with increasing headcount and preparing for the commercialization of TYMLOS in the United States. This increase was also driven by a $15.2 million increase in compensation expense, including stock-based compensation, due to the increase in headcount.
Nine Months Ended September 30, 2017
For the nine months ended September 30, 2017, Radius reported a net loss of $183.2 million, or $4.21 per share, compared to a net loss of $130.1 million, or $3.02 per share, for the nine months ended September 30, 2016.
For the nine months ended September 30, 2017 Radius reported TYMLOS net product revenues of about $4.4 million, which reflects the first full quarter of reported sales. Radius had no revenue in the nine months ended September 30, 2016 as the FDA approved TYMLOS on April 28, 2017.
Research and development expense for the nine months ended September 30, 2017, was $60.2 million compared to $81.8 million for the nine months ended September 30, 2016, a decrease of $21.6 million, or 26%. This decrease was primarily driven by a $14.9 million decrease in RAD1901 project costs, a $14.1 million decrease in abaloparatide-SC project costs, and a $2.2 million decrease in development costs associated with abaloparatide-TD. This decrease was partially offset by a $9.7 million increase in compensation expense, including stock-based compensation, due to an increase in headcount.
Selling, general, and administrative expense for the nine months ended September 30, 2017, was $135.9 million compared to $50.1 million for the nine months ended September 30, 2016, an increase of $85.8 million, or 171%. This increase was primarily the result of an increase of approximately $27.9 million in professional fees and support costs during the nine months ended September 30, 2017, including the costs associated with increasing headcount and preparing for the commercialization of TYMLOS in the United States. This increase was also driven by a $49.4 million increase in compensation expense, including stock-based compensation, due to an increase in headcount.
As of September 30, 2017, Radius had $468.1 million in cash, cash equivalents and marketable securities. Based upon our cash, cash equivalents and marketable securities balance as of September 30, 2017, we believe that, prior to the consideration of proceeds from partnering and/or collaboration activities, we have sufficient capital to fund our development plans, U.S. commercial and other operational activities for not less than twelve months from the date of this press release.