On August 5, 2021 Radius Health, Inc. ("Radius" or the "Company") (Nasdaq: RDUS), reported its financial results for the second quarter ended June 30, 2021 and year-to-date (Press release, Radius, AUG 5, 2021, View Source [SID1234585911]). In addition, the Company provided an update on components of the business.

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"Over the past 12 months we have focused on repositioning the business in a comprehensive manner," said Kelly Martin, Radius’ President and CEO. Martin continued, "within this effort three specific goals warrant being highlighted. They are, to become a cash flow positive company, to complete enrollment and execute our three ongoing pivotal trials in a high-quality manner, and opportunistically add assets that have the potential to enhance the Company’s value proposition. While there is still more to do, significant progress on all three of these objectives has been made to date."

Q2 and YTD FINANCIAL HIGHLIGHTS:

Total Net Revenue vs. prior year:
$52 million in Q2, 2021 vs. $50 million in Q2, 2020, +3% year-over-year
$108 million 1H, 2021 vs. $98 million 1H, 2020, +10% year-over-year
TYMLOS Net Revenue:
$52 million in Q2, 2021 vs. $50 million in Q2, 2020, +3% year-over-year
$97 million 1H, 2021 vs. $98 million 1H, 2020, -1% year-over-year
Total Company Adjusted EBITDA:
($6) million in Q2, 2021 vs. ($29) million in Q2, 2020
($11) million 1H, 2021 vs. ($55) million 1H, 2020
FY 2021 guidance: reiterate Adj. EBITDA of $10 million; while reducing TYMLOS revenue from $250 to $240 million
Liquidity position: $100 million of cash, cash equivalents and marketable securities as of 6/30/2021
ABALOPARATIDE COMMERCIAL UPDATE:

Patient growth continues in both quarter-over-quarter and year-over-year periods. Progress on business and market segment includes:

TYMLOS year-over-year new patient growth of 40+% in Q2, 2021 and 18% in 1H, 2021
Top 500 prescribers accounted for ~50% of new patients in Q2, 2021 vs. ~32% in Q1, 2021
In Q2, 2021, ~50% of our top 125 prescribers were orthopedic or spine-focused practices
New patient growth attributable to ortho/spine and bone health prescribers accelerated vs. prior quarter
As a reflection of the timing of new patient adds, we are reducing our FY 2021 TYMLOS net revenue guidance by $10 million. Given new patient growth during Q4, 2020 and 1H, 2021, we anticipate that the net revenue for TYMLOS in 2H, 2021 will be stronger than 1H, 2021.

The Company remains focused on making further progress in the commercial market space by concentrating resources, time, and effort on postmenopausal women with osteoporosis at high risk of fracture, including those with recent fractures.

ELACESTRANT UPDATE:

In partnership with the Menarini Group, progress continues to be made on the elacestrant asset and pivotal trial. The topline readout is still expected to occur in 2H, 2021 as previously communicated.

Importantly, there was a successful outcome in the completion of the bioequivalency study (BE study). This critical path item establishes equivalency between the clinical trial product and commercial product and is an important step forward on the progression of the asset.

Life cycle discussions and planning have been held with Menarini, and will continue to take place, regarding the possible therapeutic applications of elacestrant within the selective estrogen degrader (SERD) space.

RAD011 UPDATE:

As announced in a press release on July 23, Radius plans to initiate a seamless Phase 2/3 pivotal trial for patients with Prader-Willi Syndrome (PWS) in Q4, 2021 or early Q1, 2022. This trial will be global and incorporates feedback from the FDA, the KOL community as well as input from patient advocacy organizations.

Second Quarter 2021 Financial Results

Three Months Ended June 30, 2021

Net Loss
For the three months ended June 30, 2021, Radius reported a net loss of $16.8 million, or $0.35 per share, compared to a net loss of $43.9 million, or $0.95 per share, for the three months ended June 30, 2020.

For the three months ended June 30, 2021, non-GAAP adjusted net loss, was $10.5 million, or $0.22 per share, compared to non-GAAP adjusted net loss of $31.1 million, or $0.67 per share, for the three months ended June 30, 2020.

Revenue
For the three months ended June 30, 2021, TYMLOS net product revenues were $51.8 million compared to $50.1 million for the three months ended June 30, 2020.

Costs and Expenses
For the three months ended June 30, 2021, research and development expense was $27.0 million compared to $44.9 million for the three months ended June 30, 2020, a decrease of $17.9 million, or 40%. This decrease was primarily driven by a decrease of $10.6 million in abaloparatide-TD program cost, a $0.4 million decrease in occupancy and depreciation costs, a $4.6 million decrease in compensation expense, which is comprised of a $1.7 million decrease in compensation expense related to headcount and $2.9 million of billed reimbursable expenses, and a $8.8 million decrease in elacestrant program costs, which is comprised of a $6.6 million increase in gross program expenses offset by $15.4 million of billed reimbursable expenses. These decreases were offset by a $0.8 million increase in abaloparatide-SC program costs, a $3.6 million increase in RAD011 program costs, and a $2.1 million increase in professional fees and other expenses.

For the three months ended June 30, 2021, selling, general and administrative expenses were $32.1 million compared to $38.2 million for the three months ended June 30, 2020, a decrease of $6.1 million, or 16%. This decrease was primarily the result of a $2.6 million decrease in compensation cost, a $3.9 million decrease in professional support costs, and a $0.2 million decrease in occupancy and depreciation costs. These decreases were partially offset by a $0.5 million increase in travel and entertainment costs, and a $0.1 million increase in other operating costs.

Six Months Ended June 30, 2021

Net Loss
For the six months ended June 30, 2021, Radius reported a net loss of $32.6 million, or $0.69 per share, compared to a net loss of $81.5 million, or $1.76 per share, for the six months ended June 30, 2020.

For the six months ended June 30, 2021, non-GAAP adjusted net loss, was $19.0 million, or $0.40 per share, compared to non-GAAP adjusted net loss of $58.6 million, or $1.26 per share, for the six months ended June 30, 2020.

Revenue
For the six months ended June 30, 2021, TYMLOS net product revenues were $97.1 million compared to $98.0 million for the six months ended June 30, 2020.

For the six months ended June 30, 2021, license revenue was $11.0 million. No license revenue was recognized for the six months ended June 30, 2020.

Costs and Expenses
For the six months ended June 30, 2021, research and development expense was $58.4 million compared to $83.9 million for the six months ended June 30, 2020, a decrease of $25.5 million, or 30%. This decrease was primarily driven by a decrease of $14.0 million in abaloparatide-TD program cost, a $0.2 million decrease in RAD140 program costs, a $0.8 million decrease in occupancy and depreciation costs, a $9.3 million decrease in compensation expense, which is comprised of a $2.8 million decrease in compensation expense related to headcount and $6.5 million of billed reimbursable expenses, and a $16.4 million decrease in elacestrant program costs, which is comprised of a $9.6 million increase in gross program expenses offset by $26.0 million of billed reimbursable expenses. These decreases were offset by a $6.1 million increase in abaloparatide-SC program costs, a $3.6 million increase in RAD011 program costs, and a $5.8 million increase in professional fees and other expenses.

For the six months ended June 30, 2021, selling, general and administrative expenses were $66.2 million compared to $74.7 million for the six months ended June 30, 2020, a decrease of $8.4 million, or 11%. This decrease was primarily the result of a $2.0 million decrease in professional support costs, a $6.1 million decrease in compensation cost, and a $0.3 million decrease in other operating costs.

Webcast and Conference Call

In connection with today’s reporting of Second Quarter 2021 Financial Results, Radius will host a conference call and live audio webcast at 8:30 a.m. ET today, August 5, 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.

A replay of the conference call will be available on August 5 at 11:30 a.m. ET and the audio webcast of the call will be archived on the Company’s website for ninety days. To access the replay, dial (855) 859-2056 or (404) 537-3406 for International, using conference ID number 3659752. The live audio webcast of the call can be accessed from the Investors section of the Company’s website, View Source The full text of the announcement and financial results will also be available on the Company’s website.