- TYMLOS® Q3, 2021 net revenue:
$57 million , +13% vs. Q3, 2020 - Added 4,461 new patients on TYMLOS in Q3, 2021, +10% vs. Q3, 2020
- Adjusted EBITDA of
($11) million vs.$9 million in Q3, 2020 which included elacestrant license revenue - ATOM Pivotal Study evaluating abaloparatide-SC for use in males with osteoporosis met primary and key secondary endpoints; sNDA filing is expected Q1, 2022
- Resubmitted abaloparatide-SC to the
European Medicines Agency (EMA) onNovember 4, 2021 - wearABLe Pivotal Study (abaloparatide-TD) topline readout remains on track for Q4, 2021
- EMERALD Pivotal Study evaluating elacestrant in breast cancer was positive as a monotherapy vs. standard of care in patients with ER+/HER2- mBC, including ESR1 patients
- Working with our partner –
Menarini Group – onU.S. andEurope regulatory submissions in 2022 Menarini Group is planning several combination trials with elacestrant- Data to be shared at the San Antonio Breast Cancer Symposium taking place in December, 2021
- Working with our partner –
- Return of Capital: Radius intends to utilize a minimum of 50% of the up to
$300 million in potential future sales milestones from elacestrant to strengthen its capital structure
Q3, 2021 FINANCIAL HIGHLIGHTS:
- TYMLOS Net Revenue:
$57 million in Q3, 2021 vs.$50 million in Q3, 2020, +13% year-over-year - Total Company Headcount: 285 in Q3, 2021 vs. 317 in Q3, 2020 a 10% reduction
- TYMLOS Net Revenue per commercial employee: 50% increase in productivity in Q3, 2021 vs. Q3, 2020
- Total Net Revenue:
$57 million in Q3, 2021 vs.$78 million in Q3, 2020, -27% year-over-year due to$27 million in upfront license revenue received fromMenarini Group for the elacestrant asset - Total Company Adjusted EBITDA:
($11) million in Q3, 2021 vs.$9 million in Q3, 2020, down year-over-year as 2020 results included the elacestrant upfront license revenue - RAD011 expenses increased by
$5.5 million driven by life cycle planning and key talent recruitment - Total Operating Expenses:
$69 million in Q3, 2021 vs.$73 million in Q3, 2020 - Liquidity position:
$110 million of cash, cash equivalents and marketable securities as of9/30/2021
Our shift from a general osteoporosis sales approach to one that focuses on – primarily – the fracture patient segment continues to evolve. We have made progress and expect to make more in the future. However, due to lower-than-expected year-to-date TYMLOS net revenue, the Company is making the following changes to full year 2021 forecasts:
- TYMLOS Net Revenue FY 2021: now
$210 to$220 million vs. previous forecast of$240 million - Total Company FY 2021 Adjusted EBITDA: now (
$5 ) to($15) million vs. previous forecast of$10 million
ELACESTRANT:
On
Kelly Martin, Chief Executive Officer of Radius, elaborated, “We work closely with the
He added, “Given the significance of the positive topline data to Radius, it is important to outline key aspects of the molecule as well as the financial/business relationship that exists between the
Martin concluded, “Creating tangible value for our capital providers is a fundamental objective of our business and central to our management approach and operating philosophy. To that end, we intend to utilize a minimum of 50% of the up to
As to the detail – mentioned above – the following five (5) items are of particular relevance to Radius shareholders, capital providers, and other stakeholders:
- Radius is eligible to receive:
- Up to
$20 million in development and regulatory milestone payments - Up to
$300 million in sales milestones - A tiered net royalty up to 9% that is based on global net sales
- Up to
- Royalties and sales milestones are:
- Based on global net sales of elacestrant
- Inclusive of monotherapy as well as any/all utilization as a combination therapeutic
- Inclusive of all other potential therapeutic applications
- Intellectual Property – three (3)
U.S. issued patents for elacestrant:- Composition of matter (
August 2026 , subject to patent term extension up toAugust 2030 ) - Method of treatment (
October 2034 ) - Polymorph/Crystalline (
January 2038 ) - Additional patents are pending
- Composition of matter (
- Exclusivity – as a new chemical entity, elacestrant has the potential to receive regulatory exclusivity of:
- 5 years in the
U.S. - 10 years in
Europe - 8 years in
Japan , assuming no generic competitor entrant to the market - All the above are subject to regulatory approval(s)
- 5 years in the
- Radius intends to utilize a minimum of 50% of the up to
$300 million in potential future sales milestones from elacestrant to strengthen its capital structure
ABALOPARATIDE:
Clinical and Regulatory
- Resubmitted abaloparatide-SC dossier to the EMA for potential approval in the EU on
November 4, 2021 - Announced that the ATOM study evaluating abaloparatide-SC for use in males with osteoporosis met its primary endpoint as well as key secondary endpoints with plans to submit a sNDA in Q1, 2022
- Previously announced an update to the MOA section of the TYMLOS label following data from the histomorphometry study that showed TYMLOS stimulated new bone formation in humans
- Assist partner,
Paladin Labs Inc. , in the abaloparatide regulatory submission inCanada (Q4, 2021)
Commercial
- Added 4,461 new patients on TYMLOS in Q3, 2021, +10% vs. Q3, 2020
- Top 500 TYMLOS prescribers represent 50% of total new patients in Q3, 2021
- Top 50 TYMLOS prescribers had new patient growth of 15% vs. Q2, 2021
- Full year TYMLOS Net Revenue projection has been adjusted to
$210 to$220 million vs.$240 million - Our focus on continuing to position TYMLOS for additional growth:
- Increase depth vs. breadth in the fracture patient segments
- Emphasis on best people and talent aligned to the opportunity
- Properly utilize data – with larger institutions – for patient identification, tracking, and interface
- Prepare for the possibility of adding male indication to TYMLOS
- Plan for abaloparatide-TD following pivotal data readout expected in Q4, 2021
RAD011:
All remains on track as previously communicated for Prader-Willi Syndrome (PWS). The seamless pivotal trial (SCOUT) is expected to commence in Q4, 2021 or early Q1, 2022.
We will provide a further update on the RAD011 molecule in the near term. We plan to add at least two additional neurological orphan disease indications and progress those forward with pivotal trials.
Third Quarter 2021 Financial Results
Three Months Ended
Net Loss
For the three months ended
For the three months ended
Revenue
For the three months ended
For the three months ended
Costs and Expenses
For the three months ended
For the three months ended
Nine Months Ended
Net Loss
For the nine months ended
For the nine months ended
Revenue
For the nine months ended
For the nine months ended
Costs and Expenses
For the nine months ended
For the nine months ended
Consolidated Balance Sheets
(Amounts in thousands, except share and per share amounts)
2021 | 2020 | |||||||
ASSETS | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 109,559 | $ | 91,436 | ||||
Restricted cash | 567 | 567 | ||||||
Marketable securities | - | 23,280 | ||||||
Accounts receivable, net | 26,545 | 20,310 | ||||||
Inventory | 11,604 | 9,174 | ||||||
Prepaid expenses | 9,131 | 13,279 | ||||||
Other current assets | 20,070 | 22,502 | ||||||
Total current assets | 177,476 | 180,548 | ||||||
Property and equipment, net | 660 | 796 | ||||||
Intangible assets | 5,186 | 5,785 | ||||||
Right of use assets - operating leases | 720 | 3,933 | ||||||
Other assets | 2,141 | 520 | ||||||
Total assets | $ | 186,183 | $ | 191,582 | ||||
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 13,548 | $ | 9,925 | ||||
Accrued expenses and other current liabilities | 75,766 | 59,758 | ||||||
Deferred Revenue | - | 1,000 | ||||||
Operating lease liability, current | 725 | 2,490 | ||||||
Total current liabilities | 90,039 | 73,173 | ||||||
Convertible notes payable | 190,272 | 213,645 | ||||||
Term loan | 148,057 | 24,905 | ||||||
Operating lease liability, long term | 364 | 3,518 | ||||||
Total liabilities | 428,732 | 315,241 | ||||||
Stockholders’ equity (deficit): | ||||||||
Common stock, | 5 | 5 | ||||||
Additional paid-in-capital | 1,109,843 | 1,222,137 | ||||||
Accumulated other comprehensive income (loss) | - | 21 | ||||||
Accumulated deficit | (1,352,397 | ) | (1,345,822 | ) | ||||
Total stockholders’ equity (deficit) | (242,549 | ) | (123,659 | ) | ||||
Total liabilities and stockholders’ equity (deficit) | $ | 186,183 | $ | 191,582 |
Consolidated Statement of Operations and Comprehensive Loss
(Amounts in thousands, except share and per share amounts)
Three Months Ended | Nine Months Ended | ||||||||||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||||||||||
REVENUES: | |||||||||||||||||||
Product revenue, net | $ | 56,810 | $ | 50,412 | $ | 153,867 | $ | 148,448 | |||||||||||
License Revenue | - | 27,414 | 11,000 | 27,414 | |||||||||||||||
Total Revenue | 56,810 | 77,826 | 164,867 | 175,862 | |||||||||||||||
OPERATING EXPENSES: | |||||||||||||||||||
Cost of sales - product | 4,873 | 3,839 | 13,192 | 11,771 | |||||||||||||||
Cost of sales - intangible amortization | 200 | 200 | 599 | 599 | |||||||||||||||
Research and development, net of amounts reimbursable (a) | 34,738 | 39,450 | 93,128 | 123,340 | |||||||||||||||
Selling, general, and administrative | 34,256 | 33,692 | 100,496 | 108,356 | |||||||||||||||
Income (Loss) from operations | (17,257 | ) | 645 | (42,548 | ) | (68,204 | ) | ||||||||||||
OTHER (EXPENSE) INCOME: | |||||||||||||||||||
Other income (expense) | 90 | (87 | ) | 10 | (144 | ) | |||||||||||||
Interest expense | (4,873 | ) | (7,069 | ) | (14,084 | ) | (20,747 | ) | |||||||||||
Interest income | 7 | 222 | 70 | 1,272 | |||||||||||||||
Gain on extinguishment of debt | - | - | 1,960 | - | |||||||||||||||
NET LOSS | $ | (22,033 | ) | $ | (6,289 | ) | $ | (54,592 | ) | $ | (87,823 | ) | |||||||
OTHER COMPREHENSIVE LOSS: | |||||||||||||||||||
Unrealized gain (loss) from available-for-sale debt securities | - | (26 | ) | (21 | ) | 79 | |||||||||||||
COMPREHENSIVE LOSS | $ | (22,033 | ) | $ | (6,315 | ) | $ | (54,613 | ) | $ | (87,744 | ) | |||||||
LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS - BASIC AND DILUTED: | $ | (22,033 | ) | $ | (6,289 | ) | $ | (54,592 | ) | $ | (87,823 | ) | |||||||
LOSS PER SHARE: | |||||||||||||||||||
Basic and diluted | $ | (0.47 | ) | $ | (0.14 | ) | $ | (1.16 | ) | $ | (1.89 | ) | |||||||
WEIGHTED AVERAGE SHARES: | |||||||||||||||||||
Basic and diluted | 47,288,212 | 46,493,126 | 47,173,337 | 46,395,124 | |||||||||||||||
(a) Amounts reimbursable for the three and nine months ended | |||||||||||||||||||
Reconciliation of GAAP to Non-GAAP Financial Information
(Unaudited amounts in thousands, except share and per share amounts)
Three Months Ended | Nine Months Ended | ||||||||||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||||||||||
Net loss reconciliation: | |||||||||||||||||||
GAAP net loss | $ | (22,033 | ) | $ | (6,289 | ) | $ | (54,592 | ) | $ | (87,823 | ) | |||||||
Intangible amortization | 200 | 200 | 599 | 599 | |||||||||||||||
Stock-based compensation expense | 6,083 | 6,522 | 17,197 | 19,821 | |||||||||||||||
Restructuring charges | - | - | - | - | |||||||||||||||
Depreciation | 42 | 472 | 137 | 1,020 | |||||||||||||||
Non-cash interest | 415 | 4,588 | 1,189 | 13,313 | |||||||||||||||
Gain on extinguishment of debt | - | - | (1,960 | ) | - | ||||||||||||||
Debt refinancing charges | - | - | 3,143 | - | |||||||||||||||
Operating lease impairment | - | 1,510 | - | 1,510 | |||||||||||||||
Non-GAAP net loss | $ | (15,293 | ) | $ | 7,003 | $ | (34,287 | ) | $ | (51,560 | ) | ||||||||
Reconciliation of diluted loss per share: | |||||||||||||||||||
GAAP loss per share | $ | (0.47 | ) | $ | (0.14 | ) | $ | (1.16 | ) | $ | (1.89 | ) | |||||||
Intangible amortization | 0.00 | 0.00 | 0.01 | 0.01 | |||||||||||||||
Stock-based compensation expense | 0.13 | 0.14 | 0.36 | 0.43 | |||||||||||||||
Restructuring charges | - | - | - | - | |||||||||||||||
Depreciation | 0.00 | 0.01 | 0.00 | 0.02 | |||||||||||||||
Non-cash interest | 0.01 | 0.10 | 0.03 | 0.29 | |||||||||||||||
Gain on extinguishment of debt | - | - | (0.04 | ) | - | ||||||||||||||
Debt refinancing charges | - | - | 0.07 | - | |||||||||||||||
Operating lease impairment | - | 0.03 | - | 0.03 | |||||||||||||||
Non-GAAP loss per share | $ | (0.32 | ) | $ | 0.15 | $ | (0.73 | ) | $ | (1.11 | ) | ||||||||
Reconciliation of shares used in loss per share calculation: | |||||||||||||||||||
GAAP shares used in loss per share | 47,288,212 | 46,493,126 | 47,173,337 | 46,395,124 | |||||||||||||||
Non-GAAP dilutive share adjustments | - | - | - | - | |||||||||||||||
Non-GAAP shares used in loss per share | 47,288,212 | 46,493,126 | 47,173,337 | 46,395,124 |
Webcast and Conference Call
In connection with today’s reporting of Third Quarter 2021 Financial Results, Radius will host a conference call and live audio webcast at
Conference Call Information:
Date:
Time:
Domestic Dial-In Number: 1 (866) 323-7965
International Dial-In Number: 1 (346) 406-0961
Conference ID: 9322858
Webcast Link: https://edge.media-server.com/mmc/p/945gpbaj
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
Use of Non-GAAP Financial Measures
To supplement our condensed consolidated financial statements, which are prepared and presented in accordance with generally accepted accounting principles in
About Radius
Radius is a global biopharmaceutical company focused on addressing unmet medical needs in the areas of bone health, orphan diseases, and oncology. Radius’ lead product, TYMLOS® (abaloparatide) injection, was approved by the
About TYMLOS (abaloparatide) injection
TYMLOS (abaloparatide) injection was approved by the
About ATOM Phase 3 Study
The ATOM Phase 3 study is a randomized, double-blind, placebo-controlled study to assess efficacy and safety of abaloparatide injection in 228 men with osteoporosis. The primary endpoint is change in lumbar spine BMD at 12 months compared with placebo, and it is expected to form the basis of a supplemental NDA seeking to expand the use of TYMLOS to treat men with osteoporosis at high risk for fracture.
About the Abaloparatide Transdermal System and wearABLe Phase 3 Study
The abaloparatide transdermal system was developed in a collaboration between Radius and
About Elacestrant (RAD1901) and EMERALD Phase 3 Study
Elacestrant is a selective estrogen receptor degrader (SERD), out-licensed to
About Prader-Willi Syndrome
PWS, an orphan disease, is a complex genetic disorder with clinical manifestations on the endocrine and neurological systems. Clinical signs of PWS develop throughout childhood, with hyperphagia and anxiety ranked as the key clinical features seeking medical attention by caregivers of individuals with PWS. Hyperphagia is a relentless, insatiable, pathological drive to eat that requires caregivers to strictly manage access to food through the locking of cabinets and refrigerators. PWS is recognized as the leading genetic cause of life-threatening obesity in children. As life-threatening hyperphagia persists into adulthood, metabolic syndrome expressed through obesity and diabetes can develop and contribute to morbidity and mortality. In addition to food-related behaviors, the behavioral symptoms commonly observed in PWS include high irritability, habitual skin picking, oppositional defiance and cognitive rigidity. There are currently no approved therapies to treat this disorder’s hyperphagia, irritability, or metabolic aspects. In the
About RAD011
Investigational drug RAD011 is a pharmaceutical-grade synthetic cannabidiol oral solution, manufactured utilizing traditional pharmaceutical manufacturing processes. The product has purity specifications that meet standardized regulatory and quality control requirements and, compared to the process of developing a plant-derived product, the synthetic manufacturing process usually enables increased consistency and greater precision in the product supply. RAD011 has been assessed in over 150 patients across multiple indications and has potential utilization in multiple endocrine and metabolic orphan diseases. Radius is initially targeting Prader-Willi syndrome (PWS) and anticipates initiating a seamless pivotal Phase 2/3 study for patients with PWS in the fourth quarter of 2021 or first quarter of 2022.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding our expectations with respect to the continued commercialization of TYMLOS in the
These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the adverse impact the ongoing COVID-19 pandemic is having and is expected to continue to have on our business, financial condition and results of operations, including our commercial operations and sales, clinical trials, preclinical studies, and employees; quarterly fluctuation in our financial results; our dependence on the success of TYMLOS, and our inability to ensure that TYMLOS will obtain regulatory approval outside the
Investor & Media Relations Contact:
Email: investor-relations@radiuspharm.com
Phone: (617) 583-2017
Source:
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