On November 5, 2019 Radius Health, Inc. ("Radius" or the "Company") (Nasdaq: RDUS), reported its financial and operating results for the third quarter ended September 30, 2019 and provided a strategic business update (Press release, Radius, NOV 5, 2019, View Source [SID1234550338]).

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Radius remains confident TYMLOS will become the anabolic market leader (based on TRx2) in 2020. In line with the Company’s goal of obtaining majority share in new patients, TYMLOS has been capturing half of new patient starts with an average 50% NBRx market share in October. Effective January 1, 2020, TYMLOS coverage will expand to approximately 290 million U.S. insured lives, representing approximately 99% of U.S. commercial and 79% of Medicare insured lives.

Radius is committed to transforming the use of anabolics to meet the unmet needs of high risk osteoporosis patients with the development and potential launch of abaloparatide-transdermal patch (abaloparatide-patch).

Radius will build on its strong scientific foundation and successful commercial franchise in osteoporosis to accelerate its growth and sharpen its strategic focus in targeted endocrine diseases. Radius will selectively evaluate in-licensing and partnership opportunities to expand its clinical pipeline and commercial assets in high potential targeted endocrine diseases.

In oncology, Radius continues to enroll patients in its EMERALD Phase 3 monotherapy study of elacestrant with completion of recruitment targeted in the third quarter of 2020. Given its focus on bone health and targeted endocrine diseases, the Company is considering all strategic options for its oncology assets to maximize their potential. The value of Radius’ oncology assets is expected to be most effectively realized by an oncology focused company with strong capabilities in this area. Radius does not plan to initiate further clinical development for elacestrant or RAD140 beyond the ongoing EMERALD study.

New Patients to Brand, NBRx PMOT. Source: IQVIA

Total Market Share, TRx PMOT. Source: IQVIA

"I am very pleased with our continued strong performance with TYMLOS. We are on a path to make TYMLOS the treatment of choice for high risk postmenopausal osteoporosis patients and shift the treatment paradigm with the patch," said Jesper Hoeiland, Chief Executive Officer of Radius. "With our refined strategy, we are excited to refocus our future by building on our core strengths and allocating resources efficiently to bring new and innovative medicines to patients and maximize opportunities for our business and shareholders."

TYMLOS (abaloparatide) injection

Third quarter 2019 U.S. net sales of TYMLOS were $47 million, a 69% increase from the third quarter of 2018. The anabolic market grew 4% in the third quarter of 2019 as compared to the third quarter of 2018.

Radius continued increasing its market share with TYMLOS capturing, on average, 38% of the U.S. anabolic osteoporosis market (based on Patient Months on Therapy, TRx PMOT) in the third quarter. In October 2019, TYMLOS achieved an average 50% NBRx share and its total market TRx share further increased to 40%.

After decisions from Aetna, Cigna and others, 2020 Medicare Part D coverage for TYMLOS will increase from 67% to 79% of those enrolled in Medicare Part D plans in the U.S. Effective January 1, 2020, TYMLOS is expected to be covered for approximately 290 million U.S. insured lives, representing approximately 99% of U.S. commercial and 79% of Medicare insured lives.

Pipeline Highlights

Abaloparatide-Patch

The wearABLe Phase 3 study which was initiated in August is now open for enrollment at more than 60 clinical sites in the U.S. reflecting strong interest from investigators. The ramp-up in patient enrollment has been slower than expected due to a higher than anticipated screen failure rate. A revised enrollment plan is being implemented that includes identified measures to improve site recruitment efforts, including adding sites outside the U.S. 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 with a majority of sites open and activated. Radius expects to complete patient recruitment in the third quarter of 2020.

Financial Highlights and Guidance

In the third quarter of 2019, TYMLOS gross profit covered the Company’s selling, general and administrative and internal research and development expenses and started partially funding the clinical pipeline projects.

Radius increased its full-year 2019 financial guidance for TYMLOS U.S. net revenues to $168 to $172 million (from $165 to $170 million) and its guidance for year-end cash, cash equivalents and investments balance to over $130 million (from $120 million).

Following an expanded formulary coverage in 2020 and increase in manufacturer reimbursement during the Medicare Part D coverage gap, the net price for TYMLOS is expected to remain flat in FY 2020 versus FY 2019.

Anticipated Milestones in Q4 2019

Elacestrant

Advance recruitment in Phase 3 EMERALD monotherapy study

TYMLOS/Financial

Grow full-year TYMLOS U.S. net sales to between $168 to $172 million

Deliver greater than $130 million cash, cash equivalents and investments balance at year-end

Expected Radius Presentations at Upcoming Conferences in Q4 2019

On November 21, 2019, the Company will present and host one-on-one meetings at the Jefferies 2019 London Healthcare Conference in London, UK.

On December 11, 2019, the Company will host one-on-one meetings at the Citi Global Healthcare Conference in New York, NY.

On December 12, 2019, the Company will host one-on-one meetings at Jefferies Denver Summit in Denver, CO.

Third Quarter 2019 Financial Results

Three Months Ended September 30, 2019

For the three months ended September 30, 2019, Radius reported a net loss of $30.0 million, or $0.65 per share, compared to a net loss of $49.8 million, or $1.09 per share, for the three months ended September 30, 2018.

For the three months ended September 30, 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 $20.4 million, or $0.44 per share, compared to non-GAAP adjusted net loss of $38.3 million, or $0.84 per share, for the three months ended September 30, 2018.

For the three months ended September 30, 2019 we recorded approximately $46.8 million of net product revenue compared to $27.6 million for the three months ended September 30, 2018.

For the three months ended September 30, 2019, research and development expense was $31.8 million compared to $26.8 million for the three months ended September 30, 2018, an increase of $5.0 million, or 19%. This increase was primarily driven by a $3.5 million increase in abaloparatide-patch program costs, a $2.0 million increase in elacestrant project costs, a $0.7 million increase in professional support costs, a $0.6 million increase in abaloparatide-SC program costs, and a $0.4 million increase in occupancy costs. These increases were partially offset by a $0.4 million decrease in RAD140 program costs and a $1.8 million decrease in compensation expense.

For the three months ended September 30, 2019, selling, general and administrative expense was $35.6 million compared to $43.7 million for the three months ended September 30, 2018, a decrease of $8.0 million, or 18%. This decrease was primarily the result of a $4.6 million decrease in professional support costs, a $2.1 million decrease in compensation related expenses attributed to a decrease in headcount from 384 selling, general, and administrative employees as of September 30, 2018 to 286 selling, general, and administrative employees as of September 30, 2019, a $0.9 million decrease in other operating costs, and a $0.5 million decrease in occupancy and depreciation costs. These decreases were partially offset by a $0.1 million increase in travel and entertainment expenses.

Nine Months Ended September 30, 2019

For the nine months ended September 30, 2019, Radius reported a net loss of $108.3 million, or $2.36 per share, compared to a net loss of $180.2 million, or $3.98 per share, for the nine months ended September 30, 2018.

For the nine months ended September 30, 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 $77.6 million, or $1.69 per share, compared to non-GAAP adjusted net loss of $133.0 million, or $2.94 per share, for the nine months ended September, 2018.

For the nine months ended September 30, 2019 we recorded approximately $117.7 million of net product revenue compared to $64.8 million for the nine months ended September 30, 2018.

For the nine months ended September 30, 2019, research and development expense was $82.2 million compared to $76.0 million for the nine months ended September 30, 2018, an increase of $6.3 million, or 8%. This increase was primarily driven by a $10.4 million increase in abaloparatide-patch project costs, a $4.4 million increase in elacestrant program costs, a $1.5 million increase in abaloparatide-SC program costs, and $0.5 million increase in professional and support fees. These increases were partially offset by a $1.7 million decrease in RAD140 program costs, a $0.2 million decrease in occupancy and depreciation costs, a $0.1 million decrease in travel and entertainment expenses, a $0.1 million decrease in other operating costs, and a $8.4 million decrease in compensation and personnel costs due to decreases in stock compensation, severance, temporary services of consultants, and headcount.

For the nine months ended September 30, 2019, selling, general and administrative expense was $116.9 million compared to $140.3 million for the nine months ended September 30, 2018, a decrease of $23.3 million, or 17%. This decrease was primarily the result of a $13.0 million decrease in compensation related to a decrease in headcount from 384 selling, general, and administrative employees as of September 30, 2018 to 286 selling, general, and administrative employees as of September 30, 2019, a $5.5 million decrease in professional support fees, a $2.7 million decrease in travel and entertainment related costs, a $1.8 million decrease in other operating costs, and a $0.3 decrease in occupancy and depreciation costs.

As of September 30, 2019, Radius had $168.7 million in cash, cash equivalents, restricted cash, and marketable securities. Based upon our cash, cash equivalents and marketable securities balance as of September 30, 2019, 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.

Webcast and Conference Call

In connection with today’s reporting of Third Quarter 2019 Financial Results, Radius will host a conference call and live audio webcast at 4:30 p.m. ET today, November 5, 2019, to review the commercial, research and development, and financial highlights and provide a Company update.

Conference Call Information:

Date: November 5, 2019

Time: 4:30 p.m. ET

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

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

Conference ID: 2490257

Live webcast:
View Source

For those unable to participate in the conference call or webcast, a replay will be available on Tuesday, November 5, 2019 at 7:30 p.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 2490257.

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.