On March 1, 2018 Radius Health, Inc. ("Radius" or the "Company") (Nasdaq:RDUS), today reported its financial results for the fourth quarter and full year ended December 31, 2017, and provided a business update (Press release, Radius, MAR 1, 2018, View Source [SID1234524327]).
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"Our fourth-quarter and full year results highlight the great performance of TYMLOS which we expect to become the leader in the anabolic market," said Jesper Høiland, President and Chief Executive Officer of Radius.
"I’m also very pleased to announce that in January we aligned with the FDA on a regulatory path for our investigational abaloparatide patch, a novel technology with potential to provide a convenient, alternative treatment option for osteoporosis patients. This innovation is aimed at expanding both the abaloparatide and total anabolic addressable markets. We are also excited to announce that we have entered into a commercial supply agreement with 3M Company under which 3M has agreed to exclusively manufacture commercial supplies of abaloparatide patches," Mr. Høiland continued.
"Following the strong single-agent activity seen in our elacestrant Phase 1 study, we have finalized our global development strategy based on recent feedback from the EMA and the FDA. We expect to initiate a global, randomized, comparator-controlled Phase 2 study of elacestrant as a third-line monotherapy for ER-positive/HER2-negative advanced or metastatic breast cancer in the second half of 2018. Depending on the study results, this single trial could support applications for global marketing approvals."
"I believe our clinical progress and operational performance during 2017 have built solid momentum for a strong 2018 for Radius," Mr. Høiland concluded.
TYMLOS (abaloparatide injection)
Fourth-quarter sales of TYMLOS in the U.S. (the second full quarter since its launch) were $7.7 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.
Nine months after launch, TYMLOS has surpassed the level of commercial market access for the competing anabolic product, with approximately 259 million covered lives and 93% coverage in commercial plans. TYMLOS coverage in Medicare Part D plans has also increased to 41%.
TYMLOS market share continued to increase in the fourth quarter to approximately 32% of new patients starting anabolic therapy (NBRx) and 13% of total prescriptions in the anabolic market. The anabolic market also showed growth in 2017, for the first time since 2012.
A 5.9% price increase for TYMLOS took effect on February 22, 2018.
In the fourth quarter, a labeling supplement for TYMLOS was submitted to the FDA 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.
Pipeline Updates
Abaloparatide-Transdermal Patch (TD)
In January 2018, Radius met with the FDA to align on a 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 (BMD) at 12 months. The Company expects to initiate this pivotal trial in mid-2019.
In addition, on February 27, 2018, Radius entered into a scale-up and commercial supply agreement with 3M in which 3M agreed to exclusively manufacture commercial supplies of abaloparatide patches. As part of the agreement, in addition to per unit transfer prices, Radius will pay 3M a mid-to-low single digit royalty on worldwide net sales of abaloparatide patches and reimburse 3M for certain capital expenditures incurred to establish commercial supply of abaloparatide patches.
Abaloparatide — Subcutaneous (SC)
European MAA
Radius’ European Marketing Authorization 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 December 15, 2017, the CHMP issued a third Day-180 List of Outstanding Issues. As part of its ongoing risk-benefit assessment, the CHMP 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.
Male Osteoporosis Trial
In the fourth quarter, the Company 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 BMD at 12 months compared with placebo. The study is expected to be initiated in the first quarter of 2018.
Elacestrant (RAD1901)
An update on data as of October 30, 2017 from the Phase 1 clinical study was presented at the San Antonio Breast Cancer Symposium in December 2017, with the elacestrant 400mg single agent showing an objective response rate of 27.3%, a clinical benefit rate at 24 weeks of 47.4% and median progression free survival of 5.4 months in heavily treated, ER-positive/HER-2 negative advanced breast cancer patients. The results showed that elacestrant was well tolerated with low grade nausea and dyspepsia being the most commonly reported adverse events.
In October 2017, elacestrant received an FDA Fast Track designation. In February 2018, we received scientific advice from the EMA regarding a potential single-arm monotherapy Phase 2 trial of elacestrant in patients with ER-positive/HER2-negative advanced or metastatic breast cancer, and we had a meeting with the FDA regarding the registrational pathway for elacestrant at which we confirmed FDA’s guidance for a single-arm study and gained alignment on an alternative potential comparator study design. Based on feedback from the EMA and the FDA, we now intend to conduct a single, randomized, controlled Phase 2 trial of elacestrant as a third-line monotherapy in approximately 300 patients with ER positive/HER2 negative advanced/metastatic breast cancer. Patients in the study would be randomized to receive either elacestrant or the investigator’s choice of an approved hormonal agent and the primary endpoint of the study will be progression-free survival (PFS). The study would also include a planned interim PFS analysis. We believe that, depending on results, this single trial would support applications for global marketing approvals for elacestrant as a third-line monotherapy, including potentially accelerated approval for elacestrant in the United States. We will provide further study details when the Phase 2 study is started, which we expect will be in the second half of 2018.
Following a strategic review in December 2017, the elacestrant development program for vasomotor symptoms was discontinued.
RAD140
In September 2017, a Phase 1 study of RAD140, a nonsteroidal selective androgen receptor modulator (SARM), was initiated in patients with hormone receptor-positive, locally advanced or metastatic breast cancer. The clinical trial is designed to evaluate the safety and maximum tolerated dose of RAD140 in approximately 40 patients. We expect to provide an update on our RAD140 development program by the end of 2018.
Corporate Update
In November 2017, we announced the appointment of Joseph Kelly as Senior Vice President of Sales and Marketing, and the promotion of Amanda Mott to Senior Vice President of Market Access.
Upcoming Milestones
Abaloparatide-SC
– Initiate a male osteoporosis study in the first quarter of 2018
– Receive Committee for Medicinal Products for Human Use (CHMP) opinion regarding the EMA’s review of the abaloparatide-SC MAA in the first half of 2018
– Publication of ACTIVExtend Phase 3 data
– Enter into a partnership for the potential commercialization of abaloparatide-SC outside the US and Japan
Elacestrant
– Initiate a potentially pivotal Phase 2 clinical trial as third-line monotherapy in advanced/metastatic ER-positive/HER2-negative breast cancer patients in the second half of 2018
– Collaboration agreement for elacestrant combination
RAD140
– Continue enrollment in the Phase 1 study and provide a program update by the end of 2018.
Expected Radius Presentations at Investor Conferences in 1H 2018:
On March 12-14, the Company will present and host one-on-one meetings at the 38th Cowen Annual Healthcare Conference in Boston, Mass.
On May 8-9, the Company will present and host one-on-one meetings at the Deutsche Bank Annual Healthcare Conference in Boston, Mass.
On May 15-17, the Company will present and host one-on-one meetings at the Bank of America Merrill Lynch Healthcare Conference in Las Vegas, NV.
On June 12-14, the Company will present and host one-on-one meetings at the Goldman Sachs Global Healthcare Conference in Palos Verdes, CA.
Fourth Quarter 2017 Finance Review
For the three months ended December 31, 2017, Radius reported a net loss of $71.0 million, or $1.59 per share, compared to a net loss of $52.7 million, or $1.22 per share, for the three months ended December 31, 2016.
For the three months ended December 31, 2017, Radius reported TYMLOS net product revenues of $7.7 million, which reflects the second full quarter of recorded sales. Radius had no revenue in the three months ended December 31, 2016 as the FDA approved TYMLOS on April 28, 2017.
Research and development expense for the three months ended December 31, 2017, was $22.9 million compared to $25.6 million for the three months ended December 31, 2016, a decrease of $2.7 million or 10.5 percent, primarily attributable to a decrease in R&D costs associated with the development of TYMLOS and elacestrant.
Selling, general, and administrative expense for the three months ended December 31, 2017, was $50.7 million compared to $27.5 million for the three months ended December 31, 2016, an increase of $23.2 million or 84.4 percent primarily due to personnel, promotional, and consulting expenses related to the launch of TYMLOS.
Full Year 2017 Finance Review
For the twelve months ended December 31, 2017, Radius reported a net loss of $254.2 million, or $5.80 per share, compared to a net loss of $182.8 million, or $ 4.24 per share, for the twelve months ended December 31, 2016.
For the twelve months ended December 31, 2017 Radius reported TYMLOS net product revenues of $12.1 million. Radius had no revenue in the twelve months ended December 31, 2016 as the FDA approved TYMLOS on April 28, 2017.
Research and development expense for the twelve months ended December 31, 2017, was $83.1 million compared to $107.4 million for the twelve months ended December 31, 2016, a decrease of $24.3 million or 22.6 percent primarily due to the reduction in R&D expenses associated with the elacestrant projects and the development of TYMLOS.
Selling, general, and administrative expense for the twelve months ended December 31, 2017, was $186.7 million compared to $77.5 million for the twelve months ended December 31, 2016, an increase of $109.2 million, or 140.9%, primarily attributable to personnel and other support costs resulting from the commercial launch of TYMLOS.
As of December 31, 2017, Radius had $430.3 million in cash, cash equivalents and marketable securities. Based upon our cash, cash equivalents and marketable securities balance, 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.
Webcast and Conference Call
In connection with today’s reporting of Fourth Quarter and Full Year Financial Results, Radius will host a conference call and live audio webcast at 4:30 p.m. ET on Thursday, March 1, 2018 to discuss the commercial outlook for TYMLOS, review the financial results and provide a Company update.
Webcast Information:
Date: Thursday, March 1, 2018
Time: 4:30 p.m. ET
Live webcast: View Source
A replay of the webcast will be available on the Company’s website, www.radiuspharm.com in the Investor section under Events and Presentations for 7 days following the live webcast.
Conference Call Information:
Domestic Dial-in Number: (866) 323-7965
International Dial-in Number: (346) 406-0961
Conference ID: 3484256
For those unable to participate in the conference call or webcast, a replay will be available beginning March 1, 2018, at 7:30 p.m. ET until March 8, 2018 at 7:30 p.m. ET. To access the replay, dial (855) 859-2056 for U.S. or (404) 537-3406 for International. The replay pin number is 3484256.
A live audio webcast of the call can be accessed from the Investors section of the Company’s website, www.radiuspharm.com, where a webcast replay will be also available for 14 days. The full text of the announcement and financial results will also be available on the Company’s website.