On February 27, 2020 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, 2019 and provided a business update (Press release, Radius, FEB 27, 2020, View Source [SID1234554869]).

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"I am very pleased that TYMLOS exited 2019 with a December majority share of postmenopausal osteoporosis patients starting on anabolic therapy in the U.S. market. In 2020, we have three critical objectives: continue expanding our market share for TYMLOS, reach anabolic total market share leadership, and complete recruitment in our three pivotal Phase 3 studies," said Jesper Hoeiland, President and Chief Executive Officer of Radius.

TYMLOS (abaloparatide) injection

Fourth quarter 2019 U.S. net sales of TYMLOS were $55.7 million, a 19% increase over the prior quarter and 62% increase from the fourth quarter of 2018. Full-year 2019 U.S. net sales of TYMLOS were $173.3 million, a 75% increase over full-year 2018.

In 2019, TYMLOS captured, on average, 36% of the U.S. anabolic osteoporosis market (based on Patient Months on Therapy, TRx PMOT). In the fourth quarter of 2019, TYMLOS’ average U.S. anabolic market share rose to 41% and it achieved a 50% share of new anabolic patient starts. Radius remains confident TYMLOS will become the anabolic market leader (based on TRx2) in 2020.

TYMLOS is covered for approximately 290 million U.S. insured lives, 99% of Commercial and 83% of Medicare Part D insured lives. The Medicare Part D coverage has increased 16 percentage

US Anabolic Osteoporosis Market; New Patients to Brand: NBRx PMOT. (Source: IQVIA)

Total Market Share, TRx PMOT. Source: IQVIA

points from 2019 due to decisions from Aetna, CIGNA and Anthem to cover TYMLOS for their Medicare Part D beneficiaries in 2020.

Pipeline Highlights

Abaloparatide-SC

Radius expects to complete recruitment of the ATOM Phase 3 Study, which is assessing the efficacy and safety of abaloparatide-SC in male osteoporosis, this year and report top-line data in the second half of 2021.

Abaloparatide-Patch

The wearABLe Phase 3 study is open for enrollment at more than 60 clinical sites in the U.S., reflecting strong interest from investigators. The Company has implemented a revised enrollment plan, added more clinical sites in the U.S., and made progress filing regulatory submissions to expand sites outside the U.S. The screen failure rate which started higher than expected at the initiation of the study is improving, driven by higher screening success at targeted bone specialty sites.

Radius expects to report top-line data from the study in the second half of 2021.

Elacestrant

The EMERALD Phase 3 study is currently enrolling patients in multiple countries and is on track to complete recruitment of 466 patients in the third quarter of 2020.

Financial Highlights and Guidance

With 2019 TYMLOS U.S. net sales reaching $173 million, Radius exceeded its 2019 full-year net sales guidance of $168 to $172 million. Radius closed 2019 with $161 million cash, cash equivalents and investments balance, driven by productivity initiatives, in line with its year-end guidance to exceed $130 million.

For 2020, Radius expects full-year TYMLOS U.S. net revenue to be between $220 and $235 million and its full-year cash burn to be below $80 million.

On January 10, 2020, the Company entered into a secured, non-dilutive credit facility for up to an aggregate amount of $95 million, comprised of a term loan of up to $55 million and a $20 million revolving credit facility based on accounts receivable and inventory, with the right, subject to certain conditions, to increase the revolver by $20 million. The credit facility has a maturity date of June 1, 2024. This funding is intended to support pre-launch activities for abaloparatide-patch, evaluation of opportunities in targeted endocrine diseases, and to strengthen the Company’s minimum cash balance toward profitability.

Over the next three years (2020-2022) Radius expects TYMLOS revenue to grow at a greater than 20% compound annual growth rate and the Company to achieve profitability.

Anticipated Milestones in 2020

Clinical Pipeline

Complete recruitment in Phase 3 ATOM study

Complete recruitment in Phase 3 wearABLe study

Complete recruitment in Phase 3 EMERALD study

TYMLOS

Grow full-year TYMLOS U.S. net sales to between $220 and $235 million

Capture anabolic TRx market leadership in 2H 2020

Expected Radius Presentations at Upcoming Conferences in Q1 2020

On February 27, 2020, the Company will present and host one-on-one meetings at the 9th Annual SVB Leerink Global Healthcare Conference in New York.

On March 4, 2020, the Company will present and host one-on-one meetings at Cowen 40th Annual Health Care Conference in Boston.

On March 17, 2020, the Company will host one-on-one meetings at the Morgan Stanley Healthcare Corporate Access Day in Boston.

Fourth Quarter and Full-Year 2019 Financial Results

Three months ended December 31, 2019

For the three months ended December 31, 2019, Radius reported a net loss of $24.7 million, or $0.54 per share, compared to a net loss of $41.1 million, or $0.90 per share, for the three months ended December 31, 2018.

For the three months ended December 31, 2019, non-GAAP adjusted net loss, which excludes expenses related to stock-based compensation, depreciation, non-cash interest obligations under debt obligations, and amortization of intangible assets, was $13.3 million, or $0.29 per share, compared to non-GAAP adjusted net loss of $30.0 million, or $0.66 per share, for the three months ended December 31, 2018.

For the three months ended December 31, 2019 we recorded approximately $55.7 million of net product revenue compared to $34.4 million for the three months ended December 31, 2018.

For the three months ended December 31, 2019, research and development expense was $34.5 million compared to $23.9 million for the three months ended December 31, 2018, an increase of $10.6 million, or 44%. This increase was primarily driven by increases in elacestrant project costs and abaloparatide-patch project costs of $5.4 million and $5.7 million, respectively.

For the three months ended December 31, 2019, selling, general and administrative expense was $35.7 million compared to $43.9 million for the three months ended December 31, 2018, a decrease of $8.2 million, or 19%. This decrease was primarily the result of a $4.4 million decrease in professional fees, a $2.3 million decrease in compensation and travel costs, and a $0.9 million decrease in other operating costs.

Twelve months Ended December 31, 2019

For the twelve months ended December 31, 2019, Radius reported a net loss of $133.0 million, or $2.89 per share, compared to a net loss of $221.4 million, or $4.88 per share, for the twelve months ended December 31, 2018.

For the twelve months ended December 31, 2019, non-GAAP adjusted net loss, which excludes expenses related to stock-based compensation, restructuring plans, depreciation, non-cash interest obligations under debt obligations, impairment of operating lease right of use assets, and amortization of intangible assets, was $90.9 million, or $1.98 per share, compared to non-GAAP adjusted net loss of $163.0 million, or $3.59 per share, for the twelve months ended December 31, 2018.

For the twelve months ended December 31, 2019 we recorded approximately $173.3 million of net product revenue compared to $99.2 million for the twelve months ended December 31, 2018.

For the twelve months ended December 31, 2019, research and development expense was $116.8 million, as compared to $99.9 million for the twelve months ended December 31, 2018, an increase of $16.8 million, or 17%. This increase was primarily a result of an increase of $16.1 million in program spending for the abaloparatide-patch program, a $9.8 million increase in program spending for elacestrant research, a $1.7 million increase in professional services, and $0.6 million increase in program spending for the abaloparatide-SC program. These increases were partially offset by a $1.9 million decrease in program spending for RAD-140 program, a $0.3 million decrease in R&D support costs as well as an $9.2 million decrease in compensation related costs.

For the twelve months ended December 31, 2019, selling, general, and administrative expense was $152.7 million, as compared to $184.2 million for the twelve months ended December 31, 2018, a decrease of $31.5 million, or 17%. This decrease was primarily due to a $10.0 million decrease in professional fees related to commercial operations and general and administrative activities, a $17.9 million decrease in compensation and travel entertainment costs and a $3.6 million decrease in other costs.

As of December 31, 2019, Radius had $161.5 million in cash, cash equivalents, restricted cash, and marketable securities. Based upon our cash, cash equivalents and marketable securities balance as of December 31, 2019 and funds available to us through our credit facilities, 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.

Common stock, $0.0001 par value; 200,000,000 shares authorized, 46,189,870 shares and 45,563,693 shares issued and outstanding at December 31, 2019 and December 31, 2018, respectively

Webcast and Conference Call

In connection with today’s reporting of Fourth Quarter and Full Year 2019 Financial Results, Radius will host a conference call and live audio webcast at 8:00 a.m. ET today, February 27, 2020, to review the commercial, research and development, and financial highlights and provide a Company update.

Conference Call Information:

Date: February 27, 2020

Time: 8:00 a.m. ET

Domestic Dial-in Number: (866) 323-7965

International Dial-in Number: (346) 406-0961

Conference ID: 2998060

Live webcast: View Source

A live audio webcast of the call can be accessed from the Investors section of the Company’s website, www.radiuspharm.com. The full text of the announcement and financial results will also be available on the Company’s website.

For those unable to participate in the conference call or webcast, a replay will be available on Thursday, February 27, 2020 at 11:00 a.m. ET and will be archived on the Company’s website for 90 days. To access the replay, dial (855) 859-2056 for U.S. or (404) 537-3406 for International, using conference ID number 2998060.