Radius Health, Inc.: First Quarter 2021 Results
- Total net revenue: $56 million vs. $48 million in Q1, 2020, +17% year-over-year
- TYMLOS® U.S. product net revenue: $45 million vs. $48 million in Q1, 2020, -6% year-over-year
- Significant operating leverage improvement:
- Q1, 2021 adjusted EBITDA: ($5) million vs. ($26) million in Q1, 2020
- Q1, 2021 EPS: ($0.34) vs. ($0.81) in Q1, 2020
- Reiterating $250 million for full year 2021 net revenue guidance for the U.S. TYMLOS product
- Humana added TYMLOS to the formularies of its Medicare Advantage Plans on May 1, 2021
- Abaloparatide pivotal trials: ATOM (male) and wearABLe (TD) on schedule for 2H, 2021 readouts
- Confirming target to resubmit abaloparatide with the EMA in Q4, 2021
- Type C meeting with the FDA for RAD011 on Prader Willi Syndrome (PWS) in June
BOSTON, May 07, 2021 (GLOBE NEWSWIRE) -- Radius Health, Inc. (“Radius” or the “Company”) (Nasdaq: RDUS), today reported its financial results for the first quarter ended March 31, 2021.
The following are key components of Q1, 2021 performance:
Q1, 2021 FINANCIAL HIGHLIGHTS:
- Total net revenue improved by 17% year-over-year: $56 million in 2021 vs. $48 million in 2020
- TYMLOS U.S. product net revenue down 6% year-over-year: $45 million in 2021 vs. $48 million in 2020
- Reduced unit volumes from inventory channel destocking plus volatility in patient activity as a result of Covid-19 during 2020; there was a partial offset from an increase in net price
- TYMLOS U.S. new patient adds grew by 14% in Q1, 2021 vs. Q4, 2020
- Strong cash balance: $115 million of cash, cash equivalents and marketable securities as of 3/31/2021
- Strategic and proactive management of capital structure:
- Completed $175 million financing transaction in March, 2021
- Redeemed ~37% of aggregate principal amount of the existing 3.00% convertible notes
- Eliminated potential future dilution by ~2 million shares (~4.9% of outstanding shares)
- Improved financial flexibility with a more balanced mix of secured and unsecured tranches
- Added cash to the balance sheet to enhance liquidity
BUSINESS HIGHLIGHTS:
Abaloparatide:
- On May 1, 2021, Humana added TYMLOS to the formularies of its Medicare Advantage Plans
- Impact #1: adds ~5 million beneficiaries, which moves Medicare Part D coverage from 83% to 91%
- Impact #2: increases coverage for first line PMO patients with history of fracture from 77% to 78%
- Q1 TYMLOS new patient prescribers: 42 of top 50 HCP’s are now orthopedic or specialist bone practices
- New patient growth for this group (the 42) was 26% vs. 14% for total Q1 TYMLOS prescriber activity
- Re-submission of abaloparatide to the EMA targeted to occur in Q4, 2021
- TYMLOS Black Box Warning: FDA process ongoing with clarity expected in Q4, 2021
- Submitted data from the histomorphometry study for inclusion in the abaloparatide label
Elacestrant:
- EMERALD phase 3 trial with our partner, Menarini Group, remains on track for 2H, 2021 topline readout
RAD011:
- Type C meeting with the FDA in June, 2021 for PWS phase 3 protocol review
- RAD011 previous data to be presented at the PWSA/USA conference June 23-25, 2021
- Additional orphan indications being assessed with 2H, 2021 timetable to finalize plan(s)
- Hired Head of Science and Technology for CBD, cannabinoid derivatives, formulations and delivery
First Quarter 2021 Financial Results
Three Months Ended March 31, 2021
Net Loss
For the three months ended March 31, 2021, Radius reported a net loss of $15.7 million, or $0.34 per share, compared to a net loss of $37.7 million, or $0.81 per share, for the three months ended March 31, 2020.
For the three months ended March 31, 2021, non-GAAP adjusted net loss, was $8.6 million, or $0.18 per share, compared to non-GAAP adjusted net loss of $27.4 million, or $0.59 per share, for the three months ended March 31, 2020.
Revenue
For the three months ended March 31, 2021, TYMLOS net product revenues were $45.3 million compared to approximately $47.9 million for the three months ended March 31, 2020.
For the three months ended March 31, 2021, license revenue was $11.0 million. No license revenue was recognized for the three months ended March 31, 2020.
Costs and Expenses
For the three months ended March 31, 2021, research and development expense was $31.4 million compared to $39.0 million for the three months ended March 31, 2020, a decrease of $7.6 million, or 19%. This decrease was primarily driven by a decrease of $3.3 million in abaloparatide-TD program cost, a $4.8 million decrease in compensation expense, which is comprised of a $1.1 million decrease in compensation expense and $3.7 million of billed reimbursable expenses, and a $7.7 million decrease in elacestrant program costs, which is comprised of a $2.9 million increase in gross program expenses offset by $10.6 million of billed reimbursable expenses. These decreases were partially offset by a $5.3 million increase in abaloparatide-SC program costs and a $2.9 million increase in professional fees and other expenses.
For the three months ended March 31, 2021, selling, general and administrative expenses were $34.1 million compared to $36.4 million for the three months ended March 31, 2020, a decrease of $2.3 million, or 6%. This decrease was primarily the result of a $0.4 million decrease in travel and entertainment expenses, a $3.6 million decrease in compensation cost, and a $0.4 million decrease in other operating costs. These decreases were partially offset by a $1.9 million increase in professional support costs, and a $0.2 million increase in occupancy and depreciation costs.
Consolidated Balance Sheets
(Amounts in thousands, except share and per share amounts)
March 31, | December 31, | ||||||
2021 | 2020 | ||||||
ASSETS | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 114,124 | $ | 91,436 | |||
Restricted cash | 567 | 567 | |||||
Marketable securities | - | 23,280 | |||||
Accounts receivable, net | 26,305 | 20,310 | |||||
Inventory | 9,430 | 9,174 | |||||
Prepaid expenses | 14,291 | 13,279 | |||||
Other current assets | 29,967 | 22,502 | |||||
Total current assets | 194,684 | 180,548 | |||||
Property and equipment, net | 745 | 796 | |||||
Intangible assets | 5,585 | 5,785 | |||||
Right of use assets - operating leases | 3,575 | 3,933 | |||||
Other assets | 520 | 520 | |||||
Total assets | $ | 205,109 | $ | 191,582 | |||
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 7,782 | $ | 9,925 | |||
Accrued expenses and other current liabilities | 70,452 | 59,758 | |||||
Deferred revenue | - | 1,000 | |||||
Operating lease liability, current | 2,165 | 2,490 | |||||
Total current liabilities | 80,399 | 73,173 | |||||
Convertible notes payable | 189,859 | 213,645 | |||||
Term loan | 147,640 | 24,905 | |||||
Operating lease liability, long term | 3,221 | 3,518 | |||||
Total liabilities | 421,119 | 315,241 | |||||
Stockholders’ equity (deficit): | |||||||
Common stock, 0.0001 par value; 200,000,000 shares authorized, 47,241,098 shares and 46,779,479 shares issued and outstanding at March 31, 2021 and December 31, 2020 | 5 | 5 | |||||
Additional paid-in-capital | 1,097,539 | 1,222,137 | |||||
Accumulated other comprehensive income | - | 21 | |||||
Accumulated deficit | (1,313,554 | ) | (1,345,822 | ) | |||
Total stockholders’ equity (deficit) | (216,010 | ) | (123,659 | ) | |||
Total liabilities and stockholders’ equity (deficit) | $ | 205,109 | $ | 191,582 |
Consolidated Statement of Operations and Comprehensive Loss
(Amounts in thousands, except share and per share amounts)
Three Months Ended | |||||||
March 31, | |||||||
2021 | 2020 | ||||||
REVENUES: | |||||||
Product revenue, net | $ | 45,261 | $ | 47,923 | |||
License Revenue | 11,000 | - | |||||
Total revenue | 56,261 | 47,923 | |||||
OPERATING EXPENSES: | |||||||
Cost of sales - product | 3,925 | 3,861 | |||||
Cost of sales - intangible amortization | 200 | 200 | |||||
Research and development, net of amounts reimbursable (a) | 31,440 | 39,009 | |||||
Selling, general, and administrative | 34,097 | 36,433 | |||||
Income (Loss) from operations | (13,401 | ) | (31,580 | ) | |||
OTHER INCOME (EXPENSE): | |||||||
Other income (expense) | (1 | ) | 11 | ||||
Interest expense | (4,364 | ) | (6,756 | ) | |||
Interest income | 57 | 671 | |||||
Gain on extinguishment of debt | 1,960 | - | |||||
NET LOSS | $ | (15,749 | ) | $ | (37,654 | ) | |
OTHER COMPREHENSIVE LOSS: | |||||||
Unrealized loss from available-for-sale debt securities | (21 | ) | (669 | ) | |||
COMPREHENSIVE LOSS | $ | (15,770 | ) | $ | (38,323 | ) | |
LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS - BASIC AND DILUTED: | $ | (15,749 | ) | $ | (37,654 | ) | |
LOSS PER SHARE: | |||||||
Basic and diluted | $ | (0.34 | ) | $ | (0.81 | ) | |
WEIGHTED AVERAGE SHARES: | |||||||
Basic and diluted | 46,981,016 | 46,271,123 | |||||
(a) Amounts reimbursable were $14.3 million and $0 for the three ended March 31, 2021 and 2020. |
Reconciliation of GAAP to Non-GAAP Financial Information
(Unaudited amounts in thousands, except share and per share amounts)
Three Months Ended | |||||||
March 31, | |||||||
2021 | 2020 | ||||||
Net loss reconciliation: | |||||||
GAAP net loss | $ | (15,749 | ) | $ | (37,654 | ) | |
Intangible amortization | 200 |
By: GlobeNewswire
- 07 May 2021
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