TYMLOS® U.S. net sales were
TYMLOS continued increasing its share in the U.S. anabolic osteoporosis market capturing an average of 30% total market share and 42% share in new patients in the first quarter of 2019.
Radius expects TYMLOS to assume anabolic market leadership of new patient starts during the second half of 2019, which if achieved, is expected to translate to total TRx market leadership during 2020.
Radius tightens full-year 2019 financial guidance for TYMLOS U.S. net sales from
Conference call scheduled for
“I am very pleased to see continued strong market share gains by TYMLOS, which we believe is poised to achieve anabolic leadership of new patient starts in the second half of 2019. Our first quarter sales set the stage for continued growth throughout the year as key new account wins come online and temporary
TYMLOS (abaloparatide) injection
- First quarter 2019 U.S. net sales of TYMLOS were
$29.8 million , a 105% increase from the first quarter of 2018. The anabolic market grew 6% in the first quarter of 2019 as compared to the first quarter of 2018.
- First quarter 2019 TYMLOS U.S. net sales were impacted by anabolic market seasonality that showed lower volumes versus the fourth quarter of 2018, higher gross-to-net expenses due to the impact of the
Medicare Part D coverage gap on manufacturers and increased support for commercial patient deductibles. - In the first quarter of 2019, TYMLOS continued to increase its market share and captured, on average, 30% of the U.S. anabolic osteoporosis market (based on Patient Months on Therapy, TRx PMOT) and 42% of new anabolic patient starts (NBRx). TYMLOS continued to increase its market share in April capturing a 34% share of the U.S. anabolic osteoporosis market and over 44% of new anabolic patient starts. During the second half of 2019, Radius expects TYMLOS to become the NBRx anabolic market leader by reaching over 50% of new patient starts. If achieved, the Company further expects this performance would translate to total TRx market leadership for TYMLOS during 2020.
- At the end of the first quarter of 2019, TYMLOS was covered for approximately 283 million U.S. insured lives, representing approximately 99% of U.S. commercial, 67% of
Medicare and 97%Medicaid /Other insured lives. After the decisions ofSilverScript Insurance Company (CVS),WellCare Health Plans, Inc. , and Prime Therapeutics to cover TYMLOS for theirMedicare Part D beneficiaries in 2019, TYMLOS volume in new scripts fromMedicare Part D business increased by 22% in the first quarter of 2019 as compared to the fourth quarter of 2018. Growth of TYMLOS volume in new scripts in the commercial business was also strong with a 17% increase in the first quarter of 2019 over the fourth quarter of 2018. - As of its second anniversary since commercial launch, more than 20,000 patients have received TYMLOS. In three separate network meta-analyses1 of approved osteoporosis treatments published in the first quarter 2019, TYMLOS showed strong efficacy results in vertebral and non-vertebral fracture risk reduction.
- Radius presented a post-hoc subset analysis on postmenopausal osteoporosis patients with Type 2 diabetes from the Phase 3 ACTIVExtend Study at the
American Association of Clinical Endocrinologists conference inApril 2019 . Among this subgroup of patients, abaloparatide for subcutaneous injection (abaloparatide-SC) treatment for 18 months followed by 25 months of alendronate therapy showed numerical reductions in the risk of vertebral, nonvertebral, clinical and major osteoporotic fractures and significant improvements in bone mineral density versus placebo followed by alendronate. Previously, in the ACTIVE Study cohort that included patients with Type 2 Diabetes, use of abaloparatide-SC for 18 months led to significant improvement in lumbar spine TBS (trabecular bone score), suggesting that abaloparatide-SC improved bone microarchitecture. As the incidence of both Type 2 diabetes and osteoporosis increase with age, they frequently coexist and represent a high unmet medical need population with a lower diagnosis rate for osteoporosis, compromised bone quality and higher fracture risk.
________________________
(1) Moreno PB, Kapoor Asi N, et al. Efficacy of pharmacological therapies for the prevention of fractures in postmenopausal women; a network meta-analysis; J Clin Endocrinol Metab. 2019; 104(5)
Abaloparatide for risk reduction of nonvertebral and vertebral fractures in postmenopausal women with osteoporosis: a network meta-analysis Reginster et Al;
Drug efficacies on bone mineral density and fracture rate for the treatment of postmenopausal osteoporosis: a network meta-analysis. Yang et Al; Review for Medical and Pharmacological Sciences 2019
Financial Guidance
- Radius tightens its full-year 2019 financial guidance for TYMLOS U.S. net sales from
$155 to $175 million to$160 to $175 million and increases guidance for its year-end cash, cash equivalents and investments balance from over$100 million to over$110 million .
Pipeline Highlights
Abaloparatide-Transdermal Patch (abaloparatide-patch)
In the first quarter of 2019, Radius made continued progress in its readiness for clinical supplies for its planned Phase 3 study, reaching targeted scale-up of production and completing analytical method validations. Clinical supplies are planned to be manufactured in the second quarter of 2019 for the Phase 3 study, which the Company expects to initiate in
Anticipated Milestones in 2019
- Abaloparatide-patch
- Initiate Phase 3 study in
August 2019
- Initiate Phase 3 study in
- Elacestrant
- Advance recruitment in Phase 3 EMERALD monotherapy study
- Global co-development/co-commercialization partnership for elacestrant
- Initiate a combination trial for elacestrant in conjunction with a partner
- TYMLOS/Financial
- Grow full-year TYMLOS U.S. net sales to between
$160M to $175M - Deliver a strong balance sheet with greater than
$110M cash, cash equivalents and investments balance at year-end
- Grow full-year TYMLOS U.S. net sales to between
Expected Radius Presentations at Upcoming Conferences in Q2 2019
- On
May 16, 2019 , the Company will present and host one-on-one meetings at theBank of America Merrill Lynch 2019Health Care Conference inLas Vegas . - On
June 11-13, 2019 , the Company will host one-on-one meetings at theGoldman Sachs 40th Annual Global Healthcare Conference in Palos Verdes, CA.
First Quarter 2019 Financial Results
Three Months Ended
For the three months ended
For the three months ended
For the three months ended
Research and development expense for the three months ended
For the three months ended
As of
Condensed Consolidated Balance Sheets
(Amounts in thousands, except share and per share amounts)
March 31, | December 31, | ||||||
2019 | 2018 | ||||||
ASSETS | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 71,504 | $ | 59,321 | |||
Restricted cash | 562 | 560 | |||||
Marketable securities | 132,679 | 177,140 | |||||
Accounts receivable, net | 20,750 | 16,758 | |||||
Inventory | 5,646 | 6,210 | |||||
Prepaid expenses | 12,372 | 13,842 | |||||
Other current assets | 2,651 | 1,202 | |||||
Total current assets | 246,164 | 275,033 | |||||
Property and equipment, net | 3,570 | 4,003 | |||||
Intangible assets | 7,182 | 7,382 | |||||
Right of use assets - operating leases | 7,450 | - | |||||
Other assets | 501 | 544 | |||||
Total assets | $ | 264,867 | $ | 286,962 | |||
LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 9,880 | $ | 4,226 | |||
Accrued expenses and other current liabilities | 35,632 | 42,203 | |||||
Operating lease liability, current | $ | 2,168 | $ | - | |||
Total current liabilities | 47,680 | 46,429 | |||||
Notes payable | 183,556 | 179,806 | |||||
Operating lease liability, long term | 5,556 | - | |||||
Other non-current liabilities | 71 | 95 | |||||
Total liabilities | 236,863 | 226,330 | |||||
Stockholders’ equity: | |||||||
Common stock, $.0001 par value; 200,000,000 shares authorized, 45,967,080 shares and 45,563,693 shares issued and outstanding at March 31, 2019 and December 31, 2018, respectively | 5 | 5 | |||||
Additional paid-in-capital | 1,174,661 | 1,165,003 | |||||
Accumulated other comprehensive loss | (281 | ) | (755 | ) | |||
Accumulated deficit | $ | (1,146,381 | ) | $ | (1,103,621 | ) | |
Total stockholders’ equity | 28,004 | 60,632 | |||||
Total liabilities and stockholders’ equity | $ | 264,867 | $ | 286,962 | |||
Condensed Consolidated Statement of Operations and Comprehensive Loss –
(Amounts in thousands, except share and per share amounts)
Three Months Ended | |||||||
March 31, | |||||||
2019 | 2018 | ||||||
REVENUES: | |||||||
Product revenue, net | $ | 29,844 | $ | 14,547 | |||
OPERATING EXPENSES: | |||||||
Cost of sales - product | 3,030 | 1,088 | |||||
Cost of sales - intangible amortization | 200 | 200 | |||||
Research and development | 23,259 | 22,851 | |||||
Selling, general and administrative | 41,186 | 48,025 | |||||
Loss from operations | (37,831 | ) | (57,617 | ) | |||
OTHER (EXPENSE) INCOME: | |||||||
Other income (expense) | 4 | (104 | ) | ||||
Interest expense | (6,037 | ) | (5,566 | ) | |||
Interest income | 1,104 | 1,732 | |||||
NET LOSS | (42,760 | ) | (61,555 | ) | |||
OTHER COMPREHENSIVE LOSS: | |||||||
Unrealized gain (loss) from available-for-sale debt securities | $ | 474 | $ | (1,169 | ) | ||
COMPREHENSIVE LOSS | (42,286 | ) | (62,724 | ) | |||
LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS - BASIC AND DILUTED | $ | (42,760 | ) | $ | (61,555 | ) | |
LOSS PER SHARE: | |||||||
Basic and diluted | $ | (0.94 | ) | $ | (1.37 | ) | |
WEIGHTED AVERAGE SHARES: | |||||||
Basic and diluted | 45,671,502 | 44,937,776 | |||||
Reconciliation of GAAP to Non-GAAP Financial Information
(Unaudited amounts in thousands, except share and per share amounts)
Three Months Ended | |||||||
March 31, | |||||||
2019 | 2018 | ||||||
Net loss reconciliation: | |||||||
GAAP net loss | $ | (42,760 | ) | $ | (61,555 | ) | |
Intangible amortization | 200 | 200 | |||||
Stock-based compensation expense | 6,115 | 7,549 | |||||
Restructuring charges | 147 | - | |||||
Depreciation | 433 | 471 | |||||
Non-cash interest | 3,750 | 3,278 | |||||
Operating Lease Impairment | 339 | - | |||||
Non-GAAP net loss | $ | (31,776 | ) | $ | (50,057 | ) | |
Reconciliation of diluted loss per share: | |||||||
GAAP loss per share | (0.94 | ) | (1.37 | ) | |||
Intangible amortization | - | - | |||||
Stock-based compensation expense | 0.14 | 0.17 | |||||
Restructuring charges | - | - | |||||
Depreciation | 0.01 | 0.01 | |||||
Non-cash interest | 0.08 | 0.08 | |||||
Operating Lease Impairment | 0.01 | - | |||||
Non-GAAP loss per share | $ | (0.70 | ) | $ | (1.11 | ) | |
Reconciliation of shares used in loss per share calculation: | |||||||
GAAP shares used in loss per share | 45,671,502 | 44,937,776 | |||||
Non-GAAP dilutive share adjustments | - | - | |||||
Non-GAAP shares used in loss per share | 45,671,502 | 44,937,776 | |||||
Webcast and Conference Call
In connection with today’s reporting of First Quarter 2019 Financial Results, Radius will host a conference call and live audio webcast at
Conference Call Information:
Date:
Time:
International Dial-in Number: (346) 406-0961
Conference ID: 5856126
Live webcast:
https://edge.media-server.com/m6/p/c3hxzj9k
For those unable to participate in the conference call or webcast, a replay will be available on
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.
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 science-driven fully integrated biopharmaceutical company that is committed to developing and commercializing innovative endocrine therapeutics in the areas of osteoporosis and oncology. Radius’ lead product, TYMLOS (abaloparatide) injection, was approved by the
About TYMLOS (abaloparatide) injection
TYMLOS (abaloparatide) injection was approved by the
About Elacestrant (RAD1901)
Elacestrant is a selective estrogen receptor degrader (SERD), which is being evaluated for potential use as a once daily oral treatment for hormone-receptor positive breast cancer. Elacestrant is currently being investigated for potential use in women with advanced estrogen receptor positive, HER2 negative, breast cancer, the most common form of the disease. Studies completed to date indicate that the compound has the potential for use as a single agent or in combination with other therapies for the treatment of breast cancer.
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 for full-year TYMLOS U.S. net sales and our year-end cash, cash equivalents and investments balance; our expectations regarding commercialization of TYMLOS in the U.S., including expectations that it will become the leader in the U.S. anabolic osteoporosis market and the timing thereof; our expectations regarding our regulatory submissions, including the timing thereof; our expectations regarding our clinical trials, including the design and timing thereof; our entry into potential collaborations, including the timing thereof, including our plans to enter into a global co-development, co-commercialization partnership for elacestrant; the progress in the development of our product candidates, including abaloparatide-patch, elacestrant (RAD1901) and RAD140; each of the statements under the headings “Anticipated Milestones in 2019,” and “Expected Radius Presentations at Upcoming Conferences in Q2 2019;” the sufficiency of our cash, cash equivalents, restricted cash, marketable securities and investments balance; and the potential clinical uses and therapeutic and other benefits of our product candidates, including abaloparatide-patch, elacestrant and RAD140.
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: we expect to need to raise additional funding, which may not be available; risks related to raising additional capital; our limited operating history; 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 U.S. or be successfully commercialized in any market in which it is approved, including as a result of risk related to coverage, pricing and reimbursement; risks related to competitive products; risks related to our ability to successfully enter into collaboration agreements and any executed collaboration agreements failing to be successful; risks related to clinical trials, including our reliance on third parties to conduct key portions of our clinical trials and uncertainty that results will support our product candidate claims; the risk that adverse side effects will be identified during the development of our product candidates or during commercialization, if approved; risks related to manufacturing, supply and distribution; and the risk of litigation or other challenges regarding our intellectual property rights. These and other important risks and uncertainties discussed in our filings with the
Investor & Media Relations Contact:
Email: ewebb@radiuspharm.com
Phone: 617-551-4011
Source: Radius Health Inc.