On February 28, 2019 Radius Health, Inc. ("Radius" or the "Company") (Nasdaq: RDUS), reported its financial and operating results for the fourth quarter and full-year ended December 31, 2018 and provided a business update (Press release, Radius, FEB 28, 2019, View Source [SID1234533903]).
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"I am very pleased with the continued strong performance of TYMLOS in the U.S. market. In 2019, we expect to continue expanding our market share for TYMLOS in the U.S. anabolic market and advancing our late-stage clinical pipeline with our pivotal elacestrant and abaloparatide-patch Phase 3 studies," said Jesper Hoeiland, President and Chief Executive Officer of Radius.
TYMLOS (abaloparatide) injection
Fourth quarter 2018 U.S. net sales of TYMLOS were $34.4 million, a 25% increase over the prior quarter and 349% increase from the fourth quarter of 2017. Full-year 2018 U.S. net sales of TYMLOS were $99.2 million, a more than sevenfold increase from full-year 2017.
In 2018, TYMLOS captured, on average, 20% of the U.S. anabolic osteoporosis market (based on Patient Months on Therapy, TRx PMOT). In the fourth quarter of 2018, TYMLOS’ average U.S. anabolic market share rose to 26% and it achieved a 39% share of new anabolic patient starts. In the first six weeks of 2019, TYMLOS has reached, on average, a 29% share of the U.S. anabolic osteoporosis market and over 40% of new anabolic patient starts.
The growth trajectory of the U.S. anabolic market since TYMLOS launched in May 2017 continued in the fourth quarter of 2018, showing 7% volume growth as compared to the fourth quarter of 2017 and 8% volume growth in full-year 2018 as compared to full-year 2017.
A 5.9% price increase for TYMLOS took effect on January 1, 2019.
As of January 1, 2019, TYMLOS was covered for approximately 283 million U.S. insured lives, representing approximately 99% of U.S. commercial, 67% of Medicare and 96% Medicaid/Other
insured lives. 2019 Medicare Part D coverage for TYMLOS increased to approximately 26 million lives, or 67% of those enrolled in Medicare Part D plans in the U.S., from 18 million lives, or 44% enrollees, in 2018, after decisions from SilverScript Insurance Company (CVS), WellCare Health Plans, Inc., Prime Therapeutics and others to cover TYMLOS for their Medicare Part D beneficiaries.
Effective as of January 1, 2019, manufacturers of brand-name drugs, like TYMLOS, will be required to pay a 70% discount during the coverage gap phase of the Medicare Part D program, up from the 50% coverage gap discount required in 2018.
With 2018 TYMLOS U.S. net sales reaching $99.2 million, Radius exceeded its 2018 full-year net sales guidance of $95 to $98 million. Radius’ 2018 year-end cash, cash equivalents and investments balance of $237 million was in line with its guidance for it to exceed $220 million.
Radius maintains its 2019 financial guidance with full-year TYMLOS U.S. net sales expected to be between $155 to $175 million and its year-end cash, cash equivalents and investments balance expected to exceed $100 million.
Abaloparatide-Transdermal Patch (abaloparatide-patch)
In 2018, Radius made substantial progress in its readiness for clinical supplies for its Phase 3 study, which is expected to start in mid-2019. Scale-up of production continues to progress, a significant portion of analytical method validations are near completion and progress is being made on the patch applicator device design qualification. In the second half of 2018, Radius completed further evaluation confirming that a five minute application of abaloparatide-patch to the thigh resulted in a pharmacokinetic profile highly similar (AUC >90%) to abaloparatide-SC. Further evaluation is in progress to confirm that clinical trial subjects will be able to correctly self-administer abaloparatide-patch.
Radius has also made significant progress scaling up for potential commercial supplies of abalopartide-patch, and in partnership with 3M Company, selected Patheon, part of Thermo Fisher Scientific, to conduct the abaloparatide-patch coating process and packaging operations. Critical capital equipment for the manufacturing of commercial supplies was purchased and Radius is working with 3M to finalize engineering equipment designs. Build out of the commercial manufacturing facility at Patheon has started and equipment installation at Patheon is planned to start in the first half of 2019.
Radius initiated its Phase 3 EMERALD study of elacestrant in late November 2018. It is the first Phase 3 study to prospectively evaluate treatment benefit for second- and third-line breast
cancer patients following CDK 4/6 inhibitor therapy as well as to prospectively compare outcomes in patients whose tumors harbor estrogen receptor 1 gene (ESR1) mutations. The study is open to enrollment with a planned recruitment period of 18-21 months and potential data read-out in 2021.
In December 2017, we reported mature data from our multiple-part Phase 1 dose-escalation and expansion study of elacestrant in postmenopausal women with ER-positive and HER2-negative advanced breast cancer. As of the study cut-off date of October 30, 2017, data from 40 patients treated at the 400 mg elacestrant dose in Parts A through C of this study showed an elacestrant single agent objective response rate (ORR) of 27.3%, with six confirmed partial responses out of 22 patients with RECIST measurable disease, a 5.4 month median progression free survival (PFS) rate and 47.4% clinical benefit rate at 24 weeks. These results showed that elacestrant was well-tolerated with the most commonly reported adverse events being low grade nausea, dyspepsia and vomiting.
A preliminary review of data from a Part D cohort of this study was conducted in January 2019. The Part D Cohort was intended to study the impact of elacestrant in patients who had progressed on at least two prior lines of endocrine therapy for advanced disease, including fulvestrant and prior treatment with a CDK 4/6 inhibitor. Due to a change in the Company’s final design of its Phase 3 study of elacestrant, with a shift to target an earlier line of therapy, only 10 of the originally planned 36 subjects were enrolled in the Part D cohort. A preliminary review of the data as of December 27, 2018 showed that overall the subjects in this cohort were more heavily pretreated and a higher proportion of subjects had visceral metastases than subjects in Parts A through C of this study. In addition, out of the nine subjects in this cohort with measurable disease, four had a best response of stable disease, two of them for greater than 24 weeks. No significant differences in safety profiles were seen between Cohorts A through C compared to Cohort D. Combined data, as of December 27, 2018, from all four study Parts (A through D) at 400 mg showed that the overall elacestrant single agent ORR was 19.4% and the median PFS was 4.5 months. As of January 3, 2019, one subject remained on treatment in the Part D cohort.
The Company’s Phase 1 dose escalation study of RAD140 in HR+ breast cancer patients is ongoing and enrollment is expected to remain active through the first quarter of 2019. A provisional maximum tolerated dose (MTD) was identified and an additional cohort has been opened to further confirm tolerability, pharmacokinetics, and on-treatment pharmacodynamics effects of RAD140 at that dose.
Anticipated Milestones in 2019
Initiate Phase 3 study in mid-2019
Advance recruitment in Phase 3 EMERALD monotherapy study
Global co-development/co-commercialization partnership for elacestrant
Initiate a combination trial for elacestrant in conjunction with a partner
Grow full-year TYMLOS U.S. net sales to between $155M to $175M
Deliver a strong balance sheet with greater than $100M cash, cash equivalents and investments balance at year-end
Expected Radius Presentations at Upcoming Conferences in Q1 2019
On March 1, 2019, the Company will present and host one-on-one meetings at the Leerink Partners 8th Annual Healthcare Conference in New York.
On March 5, 2019, the Company will host one-on-one meetings at the Credit Suisse Annual Healthcare Conference in London.
On March 13, 2019, the Company will present and host one-on-one meetings at the Cowen 39th Annual Healthcare Conference in Boston.
On March 19, 2019, the Company will host one-on-one meetings at the Morgan Stanley Healthcare Corporate Access Day in Boston.
Fourth Quarter and Full Year 2018 Financial Results
Three Months Ended December 31, 2018
For the three months ended December 31, 2018, Radius reported a net loss of $41.1 million, or $0.90 per share, compared to a net loss of $71.0 million, or $1.59 per share, for the three months ended December 31, 2017.
For the three months ended December 31, 2018, non-GAAP adjusted net loss, which excludes expenses related to stock-based compensation, restructuring plans, depreciation, non-cash interest obligations under debt obligations, litigation related payments, and amortization of intangible assets, was $30.0 million, or $0.66 per share, compared to non-GAAP adjusted net loss of $60.5 million, or $1.36 per share, for the three months ended December 31, 2017.
For the three months ended December 31, 2018, TYMLOS net product revenues were $34.4 million compared to approximately $7.7 million for the three months ended December 31, 2017.
Research and development expense for the three months ended December 31, 2018 was $23.9 million compared to $22.9 million for the three months ended December 31, 2017, an increase of $1.0 million, or 4%. This increase was primarily driven by increases in elacestrant project costs and abaloparatide-patch project costs.
For the three months ended December 31, 2018, selling, general and administrative expense was $43.9 million compared to $50.7 million for the three months ended December 31, 2017, a decrease of $6.8 million, or 13%. This decrease was primarily the result of $3.7 million and $3.0 million decreases in compensation and travel related expenses and professional fees, respectively.
Twelve Months Ended December 31, 2018
For the twelve months ended December 31, 2018, Radius reported a net loss of $221.4 million, or $4.88 per share, compared to a net loss of $254.2 million, or $5.80 per share, for the twelve months ended December 31, 2017.
For the twelve months ended December 31, 2018, non-GAAP adjusted net loss, which excludes expenses related to stock-based compensation, restructuring plans, depreciation, non-cash interest obligations under debt obligations, litigation related payments, and amortization of intangible assets, was $163.0 million, or $3.59 per share, compared to non-GAAP adjusted net loss of $212.0 million, or $4.84 per share, for the twelve months ended December 31, 2017.
For the twelve months ended December 31, 2018, TYMLOS net product revenues were $99.2 million compared to approximately $12.1 million for the twelve months ended December 31, 2017.
Research and development expense for the twelve months ended December 31, 2018 was $99.9 million compared to $83.1 million for the twelve months ended December 31, 2017, an increase of $16.8 million, or 20%. This increase was primarily a result of an increase of $7.1 million in program spending for the abaloparatide-patch program, a $5.9 million increase in program spending for continuing research for TYMLOS, a $4.9 million increase in program spending for elacestrant research, and a $1.9 million increase in program spending for RAD140 research. These increases were partially offset by a $1.3 million decrease in R&D support costs as well as a $1.7 million decrease in compensation related costs primarily due to the decrease in stock compensation expense for the year ended December 31, 2018. We expect our research and development expenses to continue to increase as the result of conducting our elacestrant Phase 3 study and the expected launch in 2019 of our abaloparatide-patch Phase 3 study and related manufacturing scale-up activities.
Selling, general, and administrative expense for the twelve months ended December 31, 2018, was $184.2 million compared to $186.7 million for the twelve months ended December 31, 2017, a decrease of $2.5 million, or 1%. This decrease was primarily due to a $3.3 million decrease in professional fees related to commercial operations and general and administrative activities. This decrease was partially offset by a $0.9 million increase in dues and subscriptions.
As of December 31, 2018, Radius had $237.0 million in cash, cash equivalents, restricted cash, and marketable securities. Based upon our cash, cash equivalents and marketable securities balance as of December 31, 2018, we believe that, prior to the consideration of potential proceeds from partnering and/or collaboration activities, we have sufficient capital to fund our development plans, U.S. commercial and other operational activities for at least twelve months from the date of this press release.