On February 25, 2021 Radius Health, Inc. ("Radius" or the "Company") (Nasdaq: RDUS), reported its financial results for the fourth quarter ended December 31, 2020 as well as full year 2020 results (Press release, Radius, FEB 25, 2021, View Source [SID1234575675]). In addition, a number of brief business updates are included.

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Q4 2020 FINANCIAL AND BUSINESS HIGHLIGHTS:

Q4 2020 U.S. net sales of TYMLOS were $60 million, an 8% year-over-year increase vs. Q4 2019
TYMLOS U.S. new patient starts increased by 26% in Q4 2020 vs. Q3 2020
FY 2020 FINANCIAL AND BUSINESS HIGHLIGHTS:

FY 2020 U.S. TYMLOS net product revenue was $208 million vs. FY 2019 net product revenue of $173 million – year-over-year growth of 20%
Balance sheet: approx. $115 million of cash, cash equivalents, and marketable securities at year end
Reduced actual total company headcount by 25+% vs. full year 2020 budget
Reduced real estate footprint and infrastructure by approximately 50%
Pivoted U.S. commercial effort to focus on post-menopausal high risk fracture patients
Increased U.S. commercial productivity (net rev. per sales person) by approximately 50%
Completed elacestrant business development out-licensing transaction with the Menarini Group
Completed RAD140 business development out-licensing transaction with Ellipses Pharma Limited
Completed abaloparatide business development out-licensing transction with Paladin Labs in Canada
Completed RAD011 business development acquisition transaction for global rights
OTHER BUSINESS HIGHLIGHTS:

Abaloparatide

ATOM phase 3 study, evaluating abaloparatide for use in osteoporotic men at high risk for fracture, remains on track for 2H 2021 read-out
wearABLe phase 3 study, evaluating the effects on bone mineral density of abaloparatide delivered via a novel transdermal system, remains on track for 2H 2021 read-out
In Japan, our partner Teijin continues to make progress within the Japan regulatory and market processes
Our partner in Canada – Paladin Labs – is advancing with plans to progress the abaloparatide molecule through the regulatory process
In the EU, we continue to advance meetings and dialogue regarding a possible re-submission of abaloparatide
RAD011

A dedicated and experienced team has been created to advance the molecule and asset
Our initial focus: Prader Willi Syndrome (PWS) for the U.S. and other global markets
Assessing additional product pathways with focus on other orphan metabolic, endocrine indications
Elacestrant

EMERALD phase 3 Study, with partner Menarini Group, remains on track for a 2H 2021 read-out
Fourth Quarter 2020 Financial Results

Three Months Ended December 31, 2020

Net Loss
For the three months ended December 31, 2020, Radius reported a net loss of $21.4 million, or $0.46 per share, compared to a net loss of $24.7 million, or $0.54 per share, for the three months ended December 31, 2019.

For the three months ended December 31, 2020, non-GAAP adjusted net income, was $10.8 million, or $0.23 per share, compared to non-GAAP adjusted net loss of $13.3 million, or $0.29 per share, for the three months ended December 31, 2019.

Revenue
For the three months ended December 31, 2020, TYMLOS net product revenues were $59.9 million compared to approximately $55.7 million for the three months ended December 31, 2019.

Costs and Expenses
For the three months ended December 31, 2020, research and development expense was $36.4 million compared to $34.5 million for the three months ended December 31, 2019, an increase of $1.9 million, or 5%. This increase was primarily driven by a $16.0 million increase in RAD011 program expenses, a $3.4 million increase in abaloparatide transdermal system program costs, which was partially offset by a $18.4 million decrease in elacestrant program costs.

Twelve Months Ended December 31, 2020

Net Loss
For the twelve months ended December 31, 2020, Radius reported a net loss of $109.2 million, or $2.35 per share, compared to a net loss of $133.0 million, or $2.89 per share, for the twelve months ended December 31, 2019.

For the twelve months ended December 31, 2020, non-GAAP adjusted net loss was $62.3 million, or $1.34 per share, compared to non-GAAP adjusted net loss of $90.9 million, or $1.98 per share, for the twelve months ended December 31, 2019.

Revenue
For the twelve months ended December 31, 2020, TYMLOS net product revenues were $208.4 million compared to approximately $173.3 million for the twelve months ended December 31, 2019.

Costs and Expenses
For the twelve months ended December 31, 2020, research and development expense was $159.7 million compared to $116.8 million for the twelve months ended December 31, 2019, an increase of $43.0 million, or 37%. This increase was primarily a result of an increase of $39.9 million in program spending for the abaloparatide transdermal system project costs and an increase of $16.0 million in other costs due to the Benuvia licensing expense. These increases were partially offset by a $11.9 million decrease in program spending for elacestrant research which is a result of $39.3 million of reimbursable expenses offsetting year to date expenses.

For the twelve months ended December 31, 2020, selling, general and administrative expenses were $144.2 million compared to $152.7 million for the twelve months ended December 31, 2019, a decrease of $8.6 million, or 6%. This decrease was primarily the result of a $6.3 million decrease in professional fees, a $4.0 million decrease compensation related expenses. These decreases were offset by a $1.7 million increase in other costs.

As of December 31, 2020, Radius had $115.3 million in cash, cash equivalents, restricted cash, and marketable securities. Based upon our cash, cash equivalents and marketable securities balance as of December 31, 2020, 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 Fourth Quarter 2020 Financial Results, Radius will host a conference call and live audio webcast at 8:30 a.m. ET today, February 25, 2021, to review the commercial, research and development, and financial highlights and provide a Company update.

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 25th at 11:30 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 8266586.