Delaware | 80-0145732 | |
(State or other jurisdiction of | (IRS Employer | |
Incorporation or organization) | Identification Number) |
Large accelerated filer x | Accelerated filer o | |
Non-accelerated filer o | Smaller reporting company o | |
Emerging growth company o |
PART I FINANCIAL INFORMATION | ||
September 30, 2018 | December 31, 2017 | ||||||
(unaudited) | |||||||
ASSETS | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 62,014 | $ | 118,564 | |||
Restricted cash | 558 | 55 | |||||
Marketable securities | 172,120 | 134,714 | |||||
Accounts receivable, net | 12,908 | 4,441 | |||||
Inventory | 5,546 | 4,366 | |||||
Prepaid expenses | 10,097 | 5,175 | |||||
Other current assets | 1,193 | 2,191 | |||||
Total current assets | 264,436 | 269,506 | |||||
Investments | 42,235 | 176,978 | |||||
Property and equipment, net | 4,561 | 6,195 | |||||
Intangible assets | 7,581 | 8,180 | |||||
Other assets | 589 | 799 | |||||
Total assets | $ | 319,402 | $ | 461,658 | |||
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 6,294 | $ | 3,915 | |||
Accrued expenses and other current liabilities | 41,759 | 49,512 | |||||
Total current liabilities | 48,053 | 53,427 | |||||
Other non-current liabilities | 118 | 189 | |||||
Notes payable | 176,180 | 166,006 | |||||
Total liabilities | $ | 224,351 | $ | 219,622 | |||
Commitments and contingencies | |||||||
Stockholders’ equity: | |||||||
Common stock, $.0001 par value; 200,000,000 shares authorized, 45,539,516 shares and 44,616,586 shares issued and outstanding at September 30, 2018 and December 31, 2017, respectively | 5 | 4 | |||||
Additional paid-in-capital | 1,158,417 | 1,124,630 | |||||
Accumulated other comprehensive loss | (848 | ) | (314 | ) | |||
Accumulated deficit | (1,062,523 | ) | (882,284 | ) | |||
Total stockholders’ equity | 95,051 | 242,036 | |||||
Total liabilities and stockholders’ equity | $ | 319,402 | $ | 461,658 |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
2018 | 2017 | 2018 | 2017 | ||||||||||||
REVENUES: | |||||||||||||||
Product revenue, net | $ | 27,639 | $ | 3,469 | $ | 64,815 | $ | 4,449 | |||||||
License revenue | — | 10,000 | — | 10,000 | |||||||||||
OPERATING EXPENSES: | |||||||||||||||
Cost of sales - product | 2,193 | 253 | 4,884 | 358 | |||||||||||
Cost of sales - intangible amortization | 200 | 200 | 599 | 200 | |||||||||||
Research and development | 26,804 | 20,997 | 75,979 | 60,176 | |||||||||||
Selling, general and administrative | 43,661 | 47,723 | 140,266 | 135,943 | |||||||||||
Other operating expenses | — | — | 10,801 | — | |||||||||||
Loss from operations | (45,219 | ) | (55,704 | ) | (167,714 | ) | (182,228 | ) | |||||||
OTHER (EXPENSE) INCOME: | |||||||||||||||
Other income (expense) | 17 | (195 | ) | 83 | (212 | ) | |||||||||
Interest expense | (5,793 | ) | (2,763 | ) | (17,041 | ) | (2,763 | ) | |||||||
Interest income | 1,193 | 819 | 4,433 | 1,983 | |||||||||||
NET LOSS | $ | (49,802 | ) | $ | (57,843 | ) | $ | (180,239 | ) | $ | (183,220 | ) | |||
OTHER COMPREHENSIVE LOSS: | |||||||||||||||
Unrealized gain (loss) from available-for-sale debt securities | 442 | (1 | ) | (534 | ) | (70 | ) | ||||||||
COMPREHENSIVE LOSS | $ | (49,360 | ) | $ | (57,844 | ) | $ | (180,773 | ) | $ | (183,290 | ) | |||
LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS - BASIC AND DILUTED (Note 11) | $ | (49,802 | ) | $ | (57,843 | ) | $ | (180,239 | ) | $ | (183,220 | ) | |||
LOSS PER SHARE: | |||||||||||||||
Basic and diluted | $ | (1.09 | ) | $ | (1.31 | ) | $ | (3.98 | ) | $ | (4.21 | ) | |||
WEIGHTED AVERAGE SHARES: | |||||||||||||||
Basic and diluted | 45,498,909 | 43,999,451 | 45,291,176 | 43,535,874 |
Nine Months Ended September 30, | |||||||
2018 | 2017 | ||||||
CASH FLOWS USED IN OPERATING ACTIVITIES: | |||||||
Net loss | $ | (180,239 | ) | $ | (183,220 | ) | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
Depreciation and amortization | 2,005 | 1,385 | |||||
Amortization of discount on marketable securities, net | (199 | ) | (100 | ) | |||
Amortization of debt discount and debt issuance costs | 10,174 | 1,568 | |||||
Stock-based compensation | 22,270 | 28,785 | |||||
Changes in operating assets and liabilities: | |||||||
Inventory | (1,180 | ) | (3,074 | ) | |||
Accounts receivable, net | (8,467 | ) | (11,682 | ) | |||
Prepaid expenses and other current assets | (4,922 | ) | (5,493 | ) | |||
Other current assets | 998 | — | |||||
Other long-term assets | 210 | (7 | ) | ||||
Accounts payable | 2,379 | (2,414 | ) | ||||
Accrued expenses and other current liabilities | (7,455 | ) | 7,327 | ||||
Other non-current liabilities | (71 | ) | (166 | ) | |||
Net cash used in operating activities | (164,497 | ) | (167,091 | ) | |||
CASH FLOWS PROVIDED BY INVESTING ACTIVITIES: | |||||||
Purchases of property and equipment | (70 | ) | (2,950 | ) | |||
Payments for capitalized milestones | — | (8,712 | ) | ||||
Purchases of marketable securities | (499 | ) | (117,441 | ) | |||
Sales and maturities of marketable securities | 97,501 | 170,208 | |||||
Net cash provided by investing activities | 96,932 | 41,105 | |||||
CASH FLOWS PROVIDED BY FINANCING ACTIVITIES: | |||||||
Proceeds from exercise of stock options and warrant exercises | 8,953 | 16,167 | |||||
Proceeds from issuance of convertible debt | — | 305,000 | |||||
Payment of debt issuance costs | — | (9,360 | ) | ||||
Proceeds from issuance of shares under employee stock purchase plan | 2,565 | 2,550 | |||||
Net cash provided by financing activities | 11,518 | 314,357 | |||||
NET DECREASE IN CASH, CASH EQUIVALENTS, AND RESTRICTED CASH | (56,047 | ) | 188,371 | ||||
CASH, CASH EQUIVALENTS, AND RESTRICTED CASH AT BEGINNING OF YEAR | 118,619 | 258,614 | |||||
CASH, CASH EQUIVALENTS, AND RESTRICTED CASH AT END OF PERIOD | $ | 62,572 | $ | 446,985 | |||
SUPPLEMENTAL DISCLOSURES: | |||||||
Cash paid for income taxes | $ | 22 | $ | 26 | |||
Property and equipment purchases in accrued expenses at period end | $ | 298 | $ | 487 |
As of | As of | ||||||
September 30, 2018 | September 30, 2017 | ||||||
Cash and cash equivalents | $ | 62,014 | $ | 446,938 | |||
Restricted cash | 558 | 47 | |||||
Total cash, cash equivalents, and restricted cash shown in the statement of cash flows | $ | 62,572 | $ | 446,985 |
September 30, 2018 | |||||||||||||||
Amortized Cost Value | Gross Unrealized Gains | Gross Unrealized Losses | Fair Value | ||||||||||||
Cash and cash equivalents: | |||||||||||||||
Cash | $ | 15,236 | $ | — | $ | — | $ | 15,236 | |||||||
Money market funds | 46,778 | — | — | 46,778 | |||||||||||
Total | $ | 62,014 | $ | — | $ | — | $ | 62,014 | |||||||
Marketable securities: | |||||||||||||||
Domestic corporate debt securities | $ | 155,346 | $ | — | $ | (643 | ) | $ | 154,703 | ||||||
Agency bonds | 59,981 | — | (329 | ) | 59,652 | ||||||||||
Total | $ | 215,327 | $ | — | $ | (972 | ) | $ | 214,355 |
December 31, 2017 | |||||||||||||||
Amortized Cost Value | Gross Unrealized Gains | Gross Unrealized Losses | Fair Value | ||||||||||||
Cash and cash equivalents: | |||||||||||||||
Cash | $ | 73,302 | $ | — | $ | — | $ | 73,302 | |||||||
Money market funds | 325 | — | — | 325 | |||||||||||
Domestic corporate commercial paper | 44,937 | — | — | 44,937 | |||||||||||
Total | $ | 118,564 | $ | — | $ | — | $ | 118,564 | |||||||
Marketable securities: | |||||||||||||||
Domestic corporate debt securities | $ | 207,320 | $ | 1 | $ | (235 | ) | $ | 207,086 | ||||||
Domestic corporate commercial paper | 29,844 | — | (7 | ) | 29,837 | ||||||||||
Agency bonds | 74,842 | — | (73 | ) | 74,769 | ||||||||||
Total | $ | 312,006 | $ | 1 | $ | (315 | ) | $ | 311,692 |
• | Level 1—Quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date. |
• | Level 2—Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. |
• | Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. |
As of September 30, 2018 | |||||||||||||||
Level 1 | Level 2 | Level 3 | Total | ||||||||||||
Assets | |||||||||||||||
Cash and cash equivalents: | |||||||||||||||
Cash | $ | 15,236 | $ | — | $ | — | $ | 15,236 | |||||||
Money market funds (1) | 46,778 | — | — | 46,778 | |||||||||||
Total | $ | 62,014 | $ | — | $ | — | $ | 62,014 | |||||||
Marketable Securities | |||||||||||||||
Domestic corporate debt securities (2) | $ | — | $ | 154,703 | $ | — | $ | 154,703 | |||||||
Agency bonds (2) | — | 59,652 | — | 59,652 | |||||||||||
Total | $ | — | $ | 214,355 | $ | — | $ | 214,355 |
As of December 31, 2017 | |||||||||||||||
Level 1 | Level 2 | Level 3 | Total | ||||||||||||
Assets | |||||||||||||||
Cash and cash equivalents: | |||||||||||||||
Cash | $ | 73,302 | $ | — | $ | — | $ | 73,302 | |||||||
Money market funds (1) | 325 | — | — | 325 | |||||||||||
Domestic corporate commercial paper (2) | — | 44,937 | — | 44,937 | |||||||||||
Total | $ | 73,627 | $ | 44,937 | $ | — | $ | 118,564 | |||||||
Marketable Securities | |||||||||||||||
Domestic corporate debt securities (2) | $ | — | $ | 207,086 | $ | — | $ | 207,086 | |||||||
Domestic corporate commercial paper (2) | — | 29,837 | — | 29,837 | |||||||||||
Agency bonds (2) | — | 74,769 | — | 74,769 | |||||||||||
Total | $ | — | $ | 311,692 | $ | — | $ | 311,692 |
September 30, 2018 | December 31, 2017 | |||||||
Raw materials | $ | 4,257 | $ | 3,852 | ||||
Work in process | 636 | 313 | ||||||
Finished goods | 653 | 201 | ||||||
Total inventories | $ | 5,546 | $ | 4,366 |
September 30, 2018 | Estimated useful life | ||||
Acquired and in-licensed rights | $ | 8,712 | 11 Years | ||
Less: accumulated amortization | (1,131 | ) | |||
Total intangible asset, net | $ | 7,581 |
September 30, 2018 | December 31, 2017 | ||||||
Commercial costs and product revenue reserves | $ | 13,567 | $ | 14,300 | |||
Research and development costs | 11,212 | 8,406 | |||||
Payroll and employee benefits | 11,619 | 16,934 | |||||
Interest | 763 | 3,482 | |||||
Restructuring costs | 628 | — | |||||
Professional fees | 3,875 | 6,295 | |||||
Other current liabilities | 95 | 95 | |||||
Total accrued expenses and other current liabilities | $ | 41,759 | $ | 49,512 |
(1) | during any calendar quarter commencing after the calendar quarter ending on December 31, 2017 (and only during such calendar quarter), if the last reported sale price of the Company's common stock for at least 20 trading days (whether consecutive or not) during a period of 30 consecutive trading days ending on the last trading day of the immediately preceding calendar quarter is greater than or equal to 130% of the conversion price on each applicable trading day; |
(2) | during the five-business day period after any five-consecutive trading day period (the “measurement period”) in which the “trading price” per $1,000 principal amount of the Convertible Notes for each trading day of the measurement period was less than 98% of the product of the last reported sale price of the Company’s common stock and the conversion rate on each such trading day; |
(3) | if the Company calls the Convertible Notes for redemption, until the close of business on the business day immediately preceding the redemption date; or |
(4) | upon the occurrence of specified corporate events. |
2024 Convertible Notes | |||
Liability component: | |||
Principal | $ | 305,000 | |
Less: debt discount and issuance costs, net | $ | (128,820 | ) |
Net carrying amount | $ | 176,180 | |
Equity component: | $ | 134,450 |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
2018 | 2017 | 2018 | 2017 | ||||||||||||
Contractual interest expense | $ | 2,287 | $ | 1,195 | $ | 6,863 | $ | 1,195 | |||||||
Amortization of debt discount | 3,379 | 1,568 | 9,804 | 1,568 | |||||||||||
Amortization of debt issuance costs | 127 | — | 370 | — | |||||||||||
Total interest expense | $ | 5,793 | $ | 2,763 | $ | 17,037 | $ | 2,763 |
Years ended December 31, | Future Minimum Payments | ||
2019 | $ | 9,150 | |
2020 | 9,150 | ||
2021 | 9,150 | ||
2022 | 9,150 | ||
2023 | 9,150 | ||
2024 and Thereafter | 314,150 | ||
Total minimum payments | $ | 359,900 | |
Less: interest | (54,900 | ) | |
Less: unamortized discount | (128,820 | ) | |
Less: current portion | — | ||
Long Term Debt | $ | 176,180 |
Shares | Weighted- Average Exercise Price (in dollars per share) | Weighted- Average Contractual Life (in years) | Aggregate Intrinsic Value | |||||||||
Options outstanding at December 31, 2017 | 5,648 | $ | 37.71 | |||||||||
Granted | 1,388 | 34.43 | ||||||||||
Exercised | (461 | ) | 16.14 | |||||||||
Canceled | (407 | ) | 42.53 | |||||||||
Expired | (409 | ) | 52.04 | |||||||||
Options outstanding at September 30, 2018 | 5,759 | $ | 37.29 | 7.48 | $ | 5,728 | ||||||
Options exercisable at September 30, 2018 | 3,121 | $ | 36.56 | 6.38 | $ | 5,728 |
RSUs | Weighted- Average Grant Date Fair Value (in dollars per share) | |||||
RSUs Outstanding at December 31, 2017 | 147 | $ | 36.69 | |||
Granted | 221 | 37.83 | ||||
Vested | (24 | ) | 41.37 | |||
Forfeited | (82 | ) | 37.37 | |||
RSUs Outstanding at September 30, 2018 | 262 | $ | 37.00 |
Chargebacks, Discounts, and Fees | Government and other rebates | Returns | Total | ||||||||||||
Beginning balance at December 31, 2017 | $ | 1,986 | $ | 1,231 | $ | 421 | $ | 3,638 | |||||||
Provision related to sales in the current year | 9,750 | 15,350 | 229 | 25,329 | |||||||||||
Adjustments related to prior period sales | (76 | ) | (106 | ) | (111 | ) | (293 | ) | |||||||
Credits and payments made | (8,971 | ) | (9,257 | ) | (236 | ) | (18,464 | ) | |||||||
Ending balance at September 30, 2018 | $ | 2,689 | $ | 7,218 | $ | 303 | $ | 10,210 | |||||||
Beginning balance at December 31, 2016 | $ | — | $ | — | $ | — | $ | — | |||||||
Provision related to sales in the current year | 688 | 459 | 296 | 1,443 | |||||||||||
Adjustments related to prior period sales | — | ||||||||||||||
Credits and payments made | — | ||||||||||||||
Ending balance at September 30, 2017 | $ | 688 | $ | 459 | $ | 296 | $ | 1,443 |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
2018 | 2017 | 2018 | 2017 | ||||||||||||
Numerator: | |||||||||||||||
Net loss | $ | (49,802 | ) | $ | (57,843 | ) | $ | (180,239 | ) | $ | (183,220 | ) | |||
Denominator: | |||||||||||||||
Weighted-average number of common shares used in loss per share - basic and diluted | 45,498,909 | 43,999,451 | 45,291,176 | 43,535,874 | |||||||||||
Loss per share - basic and diluted | $ | (1.09 | ) | $ | (1.31 | ) | $ | (3.98 | ) | $ | (4.21 | ) |
Three and Nine Months Ended September 30, | ||||||
2018 | 2017 | |||||
Options to purchase common stock | 5,759,140 | 6,233,398 | ||||
Warrants | 120,532 | 605,415 | ||||
Restricted stock units | 262,002 | 108,940 |
• | our expectations regarding commercialization of TYMLOS in the U.S., including market access coverage expectations, and our ability to successfully commercialize TYMLOS in the U.S.; |
• | the therapeutic benefits and effectiveness of TYMLOS and our product candidates and the potential indications and market opportunities therefor; |
• | our ability to obtain U.S. and foreign regulatory approval for our product candidates, including supplemental regulatory approvals for TYMLOS, and the timing thereof, including the approval of abaloparatide-SC outside of the U.S. and the impact of the CHMP’s adoption of a negative opinion on our European Marketing Authorisation Application for abaloparatide-SC; |
• | our expectations regarding the timing of our regulatory submissions; |
• | our expectations for our Phase 3 study of elacestrant or other clinical trials, including projected costs, study designs or the timing for initiation, recruitment or completion; |
• | our ability to compete with other companies that are or may be developing or selling products that are competitive with TYMLOS or our investigational product candidates; |
• | anticipated trends and challenges in the market in which TYMLOS will compete and in other potential markets in which we may compete; |
• | our plans with respect to collaborations and licenses related to the development, manufacture or sale of TYMLOS and our investigational product candidates; |
• | the progress of, timing of and amount of expenses associated with our research, development and commercialization activities; |
• | the safety profile and related adverse events of TYMLOS and our investigational product candidates; |
• | the ability of our investigational product candidates to meet existing or future regulatory standards; |
• | our expectations regarding federal, state and foreign regulatory requirements; |
• | the success of our clinical studies for our investigational product candidates; |
• | our expectations as to future financial performance, expense levels, future payment obligations and liquidity sources; |
• | our ability to attract, motivate, and retain key personnel; and |
• | other factors discussed elsewhere in this Quarterly Report on Form 10-Q. |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
2018 | 2017 | 2018 | 2017 | ||||||||||||
Program-specific costs - external: | |||||||||||||||
Abaloparatide-SC* | $ | 1,344 | $ | 311 | $ | 4,561 | $ | 608 | |||||||
Abaloparatide-patch | 3,636 | 1,308 | 6,163 | 2,340 | |||||||||||
Elacestrant (RAD1901) | 6,656 | 4,083 | 13,817 | 6,990 | |||||||||||
RAD140 | 1,001 | 245 | 3,658 | 1,566 | |||||||||||
Total program-specific costs - external | $ | 12,637 | $ | 5,947 | $ | 28,199 | $ | 11,504 | |||||||
Shared-services costs - external: | |||||||||||||||
R&D support costs | 2,790 | 2,972 | 9,171 | 8,990 | |||||||||||
Other operating costs | 519 | 529 | 1,965 | 1,992 | |||||||||||
Total shared-services costs - external | $ | 3,309 | $ | 3,501 | $ | 11,136 | $ | 10,982 | |||||||
Shared-services costs - internal | |||||||||||||||
Personnel-related costs | 7,886 | 7,486 | 25,013 | 23,663 | |||||||||||
Stock-based compensation | 2,389 | 3,261 | 9,310 | 11,829 | |||||||||||
Occupancy costs | 332 | 548 | 1,562 | 1,616 | |||||||||||
Depreciation expense | 251 | 254 | 759 | 582 | |||||||||||
Total shared-services costs - internal | $ | 10,858 | $ | 11,549 | $ | 36,644 | $ | 37,690 | |||||||
Total research and development costs | $ | 26,804 | $ | 20,997 | $ | 75,979 | $ | 60,176 |
• | Shipment errors that were the result of an error by us; |
• | Quantity delivered that is greater than the quantity ordered; |
• | Product distributed by us that is damaged in transit prior to receipt by the customer; |
• | Expired product, previously purchased directly from us, that is returned during the period beginning six months prior to the product’s expiration date and ending twelve months after the product’s expiration date; |
• | Product subject to a recall; and |
• | Product that we, at our sole discretion, have specified to be returned. |
• | Expired product that is returned during the period beginning six months prior to the product’s expiration date and ending twelve months after the product’s expiration date; |
• | Product subject to a recall; and |
• | Product that we, at our sole discretion, have specified to be returned. |
Three Months Ended | ||||||||||||||
September 30, | Change | |||||||||||||
2018 | 2017 | $ | % | |||||||||||
Revenues: | ||||||||||||||
Product revenue, net | $ | 27,639 | $ | 3,469 | $ | 24,170 | 697 | % | ||||||
License revenue | — | 10,000 | (10,000 | ) | (100 | )% | ||||||||
Operating expenses: | ||||||||||||||
Cost of sales - product | 2,193 | 253 | 1,940 | 767 | % | |||||||||
Cost of sales - intangible amortization | 200 | 200 | — | — | ||||||||||
Research and development | 26,804 | 20,997 | 5,807 | 28 | % | |||||||||
Selling, general and administrative | 43,661 | 47,723 | (4,062 | ) | (9 | )% | ||||||||
Loss from operations | (45,219 | ) | (55,704 | ) | (10,485 | ) | (19 | )% | ||||||
Other (expense) income: | ||||||||||||||
Other expense | 17 | (195 | ) | 212 | 109 | % | ||||||||
Interest expense | (5,793 | ) | (2,763 | ) | 3,030 | 110 | % | |||||||
Interest income | 1,193 | 819 | 374 | 46 | % | |||||||||
Net loss | $ | (49,802 | ) | $ | (57,843 | ) | $ | (8,041 | ) | (14 | )% |
Nine Months Ended | ||||||||||||||
September 30, | Change | |||||||||||||
2018 | 2017 | $ | % | |||||||||||
Revenues: | ||||||||||||||
Product revenue, net | $ | 64,815 | $ | 4,449 | $ | 60,366 | 1,357 | % | ||||||
License revenue | — | 10,000 | (10,000 | ) | (100 | )% | ||||||||
Operating expenses: | ||||||||||||||
Cost of sales - product | 4,884 | 358 | 4,526 | 1,264 | % | |||||||||
Cost of sales - intangible amortization | 599 | 200 | 399 | 200 | % | |||||||||
Research and development | 75,979 | 60,176 | 15,803 | 26 | % | |||||||||
Selling, general and administrative | 140,266 | 135,943 | 4,323 | 3 | % | |||||||||
Other operating expenses | 10,801 | — | 10,801 | 100 | % | |||||||||
Loss from operations | (167,714 | ) | (182,228 | ) | (14,514 | ) | (8 | )% | ||||||
Other (expense) income: | ||||||||||||||
Other expense | 83 | (212 | ) | (295 | ) | (139 | )% | |||||||
Interest expense | (17,041 | ) | (2,763 | ) | 14,278 | 517 | % | |||||||
Interest income | 4,433 | 1,983 | 2,450 | 124 | % | |||||||||
Net loss | $ | (180,239 | ) | $ | (183,220 | ) | $ | (2,981 | ) | (2 | )% |
Nine Months Ended | ||||||||||||||
September 30, | Change | |||||||||||||
2018 | 2017 | $ | % | |||||||||||
Net cash (used in) provided by: | ||||||||||||||
Operating activities | $ | (164,497 | ) | $ | (167,091 | ) | $ | 2,594 | 2 | % | ||||
Investing activities | 96,932 | 41,105 | 55,827 | 136 | % | |||||||||
Financing activities | 11,518 | 314,357 | (302,839 | ) | (96 | )% | ||||||||
Net decrease in cash, cash equivalents, and restricted cash | $ | (56,047 | ) | $ | 188,371 | (244,418 | ) | (130 | )% |
Years ended December 31, | Future Minimum Payments | ||
2019 | 9,150 | ||
2020 | 9,150 | ||
2021 | 9,150 | ||
2022 | 9,150 | ||
2023 | 9,150 | ||
2024 and Thereafter | $ | 314,150 | |
Total minimum payments | $ | 359,900 | |
Less: interest | (54,900 | ) | |
Less: unamortized discount | (128,820 | ) | |
Less: current portion | — | ||
Long Term Debt | $ | 176,180 |
Incorporated by Reference | Filed/ | |||||||||||
Exhibit | Filing | Furnished | ||||||||||
Number | Exhibit Description | Form | File No. | Exhibit | Date | Herewith | ||||||
Restated Certificate of Incorporation | 8-K | 3.1 | 6/13/2014 | |||||||||
Amended and Restated By-Laws | 8-K | 3.1 | 3/2/2018 | |||||||||
10.1^ | Separation Agreement and General Release of Claims, dated September 19, 2018, between the Company and Gary Hattersley | * | ||||||||||
10.2^ | Consulting Agreement, dated September 19, 2018, between the Company and Gary Hattersley | * | ||||||||||
Certification of Chief Executive Officer pursuant to Exchange Act Rule 13a-14(a)/15d-14(a) | * | |||||||||||
Certification of Chief Financial Officer pursuant to Exchange Act Rule 13a-14(a)/15d-14(a) | * | |||||||||||
Certification of Chief Executive Officer and Chief Financial Officer Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | ** | |||||||||||
101.INS | XBRL Instance Document | * | ||||||||||
101.SCH | XBRL Taxonomy Extension Schema Document | * | ||||||||||
101.CAL | XBRL Taxonomy Extension Calculation Linkbase Document | * | ||||||||||
101.DEF | XBRL Taxonomy Extension Definition Linkbase Document | * | ||||||||||
101.LAB | XBRL Taxonomy Extension Label Linkbase Document | * | ||||||||||
101.PRE | XBRL Taxonomy Extension Presentation Linkbase Document | * | ||||||||||
RADIUS HEALTH, INC. | ||
By: | /s/ Jesper Hoeiland | |
Jesper Hoeiland | ||
President and Chief Executive Officer | ||
(Principal Executive Officer) | ||
Date: November 1, 2018 | ||
By: | /s/ Jose Carmona | |
Jose Carmona | ||
Chief Financial Officer | ||
(Principal Accounting and Financial Officer) | ||
Date: November 1, 2018 |
• | pay you salary accrued to you through the Separation Date; |
• | pay you for all accrued but unused paid time off through the Separation Date; |
• | provide you with the right to continue group health care coverage after the Separation Date under the law known as “COBRA,” which will be described in a separate written notice; and |
• | reimburse you for any outstanding, reasonable business expenses that you have incurred on the Company’s behalf through the termination of your employment, after the Company’s timely receipt of appropriate documentation pursuant to the Company’s business expense reimbursement policy. |
Option Type | Grant Date | Grant Price | Shares Granted | Shares already Exercised | Unvested Shares that will Forfeit | Vested and Exercisable at November 1, 2019 | Last Day to Exercise as ISO | Last Day to Exercise NQSO | ||
Incentive* | 11-07-2011 | $7.34 | 18,285 | 0 | 0 | 18,285 | 02-01-2019 | 02-01-2020 | ||
Incentive* | 06-05-2014 | $8.00 | 42,659 | 0 | 0 | 42,659 | 02-01-2019 | 02-01-2020 | ||
Non-Qualified | 06-05-2014 | $8.00 | 77,955 | 0 | 0 | 77,955 | 02-01-2020 | |||
Incentive* | 12-17-2014 | $30.97 | 3,228 | 0 | 0 | 3,228 | 02-01-2019 | 02-01-2020 | ||
Non-Qualified | 12-17-2014 | $30.97 | 96,772 | 0 | 0 | 96,772 | 02-01-2020 | |||
Non-Qualified** | 02-10-2016 | $29.89 | 6,470 | 0 | 3,125 | 3,345 | 02-01-2020 | |||
Non-Qualified | 02-10-2016 | $29.89 | 68,530 | 0 | 3,125 | 65,405 | 02-01-2020 | |||
Non-Qualified | 02-17-2017 | $45.65 | 75,000 | 0 | 25,000 | 50,000 | 02-01-2020 | |||
Non-Qualified | 02-13-2018 | $37.83 | 60,000 | 0 | 35,000 | 25,000 | 02-01-2020 | |||
Total: | 448,899 | 0 | 66,250 | 382,649 |
• | Severance Pay – Pursuant to Section 2(a)(ii) of the Executive Severance Agreement, the Company will pay you severance pay consisting of your salary at your final base salary rate of $434,500 per year effective for the six (6) month period immediately following the Separation Date (the “Salary Severance Period”), which equals a total severance payment of $217,250 (the “Severance Pay”). The Company shall pay you the Severance Pay in a fully taxable lump sum on the next regular payroll date after the Release becomes effective. |
• | Annual Bonus – Because you have already received your annual bonus for the 2017 calendar year, you are not entitled to any further payments under Section 2(a)(iii) of the Severance Agreement. |
• | Health Benefits – Pursuant to Section 2(a)(iv) of the Severance Agreement, the Company will pay you a fully taxable lump sum cash payment equal to the COBRA premiums necessary to continue your health insurance coverage (in effect on the Separation Date) for a period of 6 months, without regard to whether you elect continuation coverage under COBRA, subject to applicable tax withholding (the “COBRA Pay”). The Company shall pay you the COBRA Pay on the next regular payroll date after the Release becomes effective. |
1. | Definitions. |
2. | Services. |
3. | Term. |
4. | Confidentiality; Publication; Data Privacy. |
5. | Intellectual Property. |
6. | Insider Trading. |
7. | Representations. |
(a) | Radius enters into this Agreement with Consultant in order to meet a legitimate and genuine business need for the Services and that the selection of Consultant is based exclusively on Consultant’s qualifications, expertise, experience, knowledge and ability to meet this legitimate and genuine business need; |
(b) | entry into this Agreement, its performance and the payment for the Services, are in no way contingent, conditional or depending on any other previous, current, or potential future business that is or may be generated by Consultant; and |
(c) | entry into this Agreement, its performance and payment for the Services, are in no way contingent, conditional or dependent on any other previous, current, or potential future agreements between the Parties. |
(a) | Consultant has not (i) been excluded, debarred, suspended or otherwise made ineligible to exercise its or his or her profession under Applicable Laws; or (ii) engaged in any act that would be grounds for such exclusion, debarment or suspension; Upon learning or acquiring knowledge of any facts or circumstances that may lead to actions relating to the representations above, Consultant will immediately disclose such facts or circumstances to Radius; and |
(b) | Consultant is authorized to enter into this Agreement and that Consultant is not a party to any other agreement or under any obligation to any third party which would prevent Consultant from entering into this Agreement or from performing Consultant’s obligations hereunder and shall inform Radius immediately if such authorizations or permissions, including under future employment contract provisions for Consultant, are rescinded at a later date, and in such event, Radius shall have the option to terminate this Agreement immediately, pursuant to Section 3.3. |
8. | Ethical Business Practices. |
9. | DISCLAIMER. |
10. | Independent Contractor Status. |
11. | Compensation; Continued Vesting of Equity |
12. | Miscellaneous Matters. |
By: | /s/ Jesper Høiland | By: | /s/ Gary Hattersley | |
Name: | Jesper Høiland | Name: | Gary Hattersley, Ph.D. | |
Title: | President and CEO | Date: | September 19, 2018 | |
Date: | September 19, 2018 |
/s/ Jesper Hoeiland | |
Jesper Hoeiland | |
President and Chief Executive Officer |
/s/ Jose Carmona | |
Jose Carmona | |
Chief Financial Officer |
Date: | November 1, 2018 | ||
By: | /s/ Jesper Hoeiland | ||
Jesper Hoeiland | |||
President and Chief Executive Officer | |||
Date: | November 1, 2018 | ||
By: | /s/ Jose Carmona | ||
Jose Carmona | |||
Chief Financial Officer |
Document and Entity Information - shares |
9 Months Ended | |
---|---|---|
Sep. 30, 2018 |
Oct. 31, 2018 |
|
Document and Entity Information | ||
Entity Registrant Name | Radius Health, Inc. | |
Entity Central Index Key | 0001428522 | |
Document Type | 10-Q | |
Document Period End Date | Sep. 30, 2018 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Emerging Growth Company | false | |
Entity Small Business | false | |
Entity Common Stock, Shares Outstanding (in shares) | 45,539,516 | |
Document Fiscal Year Focus | 2018 | |
Document Fiscal Period Focus | Q3 |
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares |
Sep. 30, 2018 |
Dec. 31, 2017 |
---|---|---|
Statement of Financial Position [Abstract] | ||
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized (in shares) | 200,000,000 | 200,000,000 |
Common stock, shares issued (in shares) | 45,476,455 | 44,616,586 |
Common stock, shares outstanding (in shares) | 45,476,455 | 44,616,586 |
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands |
3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Sep. 30, 2018 |
Sep. 30, 2017 |
Sep. 30, 2018 |
Sep. 30, 2017 |
|
OPERATING EXPENSES: | ||||
Cost of sales - intangible amortization | $ 200 | $ 200 | $ 599 | $ 200 |
Research and development | 26,804 | 20,997 | 75,979 | 60,176 |
Selling, general and administrative | 43,661 | 47,723 | 140,266 | 135,943 |
Other operating expenses | 0 | 0 | 10,801 | 0 |
Loss from operations | (45,219) | (55,704) | (167,714) | (182,228) |
OTHER (EXPENSE) INCOME: | ||||
Other income (expense) | 17 | (195) | 83 | (212) |
Interest expense | (5,793) | (2,763) | (17,041) | (2,763) |
Interest income | 1,193 | 819 | 4,433 | 1,983 |
NET LOSS | (49,802) | (57,843) | (180,239) | (183,220) |
OTHER COMPREHENSIVE LOSS: | ||||
Unrealized gain (loss) from available-for-sale debt securities | 442 | (1) | (534) | (70) |
COMPREHENSIVE LOSS | (49,360) | (57,844) | (180,773) | (183,290) |
LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS - BASIC AND DILUTED | $ (49,802) | $ (57,843) | $ (180,239) | $ (183,220) |
LOSS PER SHARE: | ||||
Basic and diluted (in dollars per share) | $ (1.09) | $ (1.31) | $ (3.98) | $ (4.21) |
WEIGHTED AVERAGE SHARES: | ||||
Basic and diluted (in shares) | 45,498,909 | 43,999,451 | 45,291,176 | 43,535,874 |
Product | ||||
REVENUES: | ||||
Product revenue, net | $ 27,639 | $ 3,469 | $ 64,815 | $ 4,449 |
OPERATING EXPENSES: | ||||
Cost of sales - product | 2,193 | 253 | 4,884 | 358 |
License | ||||
REVENUES: | ||||
Product revenue, net | $ 0 | $ 10,000 | $ 0 | $ 10,000 |
Organization |
9 Months Ended |
---|---|
Sep. 30, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization | Organization Radius Health, Inc. (“Radius” or the “Company”) 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. In April 2017, the Company's first commercial product, TYMLOS® (abaloparatide) injection, was approved by the U.S. Food and Drug Administration (“FDA”) for the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. In April 2018, the Company submitted a request for re-examination of the negative opinion adopted by the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) on the Company’s European Marketing Authorisation Application (“MAA”) for abaloparatide for subcutaneous administration (“abaloparatide-SC”) and in July 2018, following a re-examination procedure, the CHMP maintained its negative opinion. The Company's clinical pipeline includes an investigational abaloparatide transdermal patch (“abaloparatide-patch”) for potential use in the treatment of postmenopausal women with osteoporosis; the investigational drug elacestrant (RAD1901), a selective estrogen receptor degrader for potential use in the treatment of hormone-receptor positive breast cancer; and the investigational drug RAD140, a non-steroidal, selective androgen receptor modulator for potential use in the treatment of hormone-receptor positive breast cancer. The Company is subject to the risks associated with biopharmaceutical companies with a limited operating history, including dependence on key individuals, a developing business model, the necessity of securing regulatory approvals to market its investigational product candidates, market acceptance and the successful commercialization of TYMLOS, or any of the Company’s investigational product candidates following receipt of regulatory approval, competition for TYMLOS or any of the Company's investigational product candidates following receipt of regulatory approval, and the continued ability to obtain adequate financing to fund the Company’s future operations. The Company has incurred losses and expects to continue to incur additional losses for the foreseeable future. As of September 30, 2018, the Company had an accumulated deficit of $1,062.5 million, and total cash, cash equivalents, restricted cash, marketable securities, and investments of $276.9 million. Based upon its cash, cash equivalents, marketable securities, and investments as of September 30, 2018, the Company believes that, prior to the consideration of potential proceeds from partnering and/or collaboration activities, it has sufficient capital to fund its development plans, U.S. commercial activities and other operational activities for at least twelve months from the date of this filing. The Company expects to finance its commercial activities in the United States and development costs of its clinical product portfolio with its existing cash and cash equivalents, marketable securities and investments, as well as future product sales or through strategic financing opportunities that could include, but are not limited to, partnering or other collaboration agreements, future offerings of its equity, royalty based financing arrangements, or the incurrence of debt or other alternative financing arrangements which may include a combination of the foregoing. However, there is no guarantee that any of these strategic or financing opportunities will be executed or executed on favorable terms, and some could be dilutive to existing stockholders. If the Company fails to obtain additional capital, it may be unable to conduct its ongoing commercialization activities or complete its planned preclinical studies and clinical trials and obtain approval of certain of its investigational product candidates from the FDA or foreign regulatory authorities. |
Basis of Presentation and Significant Accounting Policies |
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Accounting Policies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Basis of Presentation and Significant Accounting Policies | Basis of Presentation and Significant Accounting Policies Basis of Presentation—The accompanying unaudited condensed consolidated financial statements and the related disclosures of the Company have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) for interim financial reporting and as required by Regulation S-X, Rule 10-01. Accordingly, they do not include all the information and footnotes required by U.S. GAAP for complete financial statements. In the opinion of management, all adjustments (including those which are normal and recurring) considered necessary for a fair presentation of the interim financial information have been included. When preparing financial statements in conformity with U.S. GAAP, the Company must make estimates and assumptions that affect the reported amounts of assets, liabilities, expenses and related disclosures at the date of the financial statements. Actual results could differ from those estimates. Additionally, operating results for the nine months ended September 30, 2018 are not necessarily indicative of the results that may be expected for any other interim period or for the fiscal year ending December 31, 2018. Subsequent events have been evaluated up to the date of issuance of these financial statements. These interim condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes, which are contained in the Company's Annual Report on Form 10-K for the year ended December 31, 2017 (“2017 Form 10-K”), filed with the Securities and Exchange Commission (“SEC”) on March 1, 2018. Certain prior period amounts have been reclassified to conform to the current period presentation. Significant Accounting Policies—The significant accounting policies identified in the Company’s 2017 Form 10-K that require the Company to make estimates and assumptions include: revenue recognition, inventory obsolescence, long-lived assets and intangible assets, accounting for stock-based compensation, contingencies, tax valuation reserves, fair value measures, and accrued expenses. There were no changes to significant accounting policies during the nine months ended September 30, 2018, except for the adoption of three Accounting Standards Updates (“ASU”) issued by the Financial Accounting Standards Board (“FASB”), which are detailed below. Accounting Standards Updates, Recently Adopted—In August 2016, the FASB issued ASU No. 2016-15, Classification of Certain Cash Receipts and Cash Payments (“ASU 2016-15”). ASU 2016-15 addresses eight specific cash flow issues with the objective of reducing the existing diversity in practice. ASU 2016-15 is effective for fiscal years, and interim periods within those years, beginning after December 15, 2017. The Company adopted this ASU as of January 1, 2018 and it did not have a material impact on its condensed consolidated financial statements. In November 2016, the FASB issued ASU 2016-18, Statement of Cash Flows: Restricted Cash (“ASU 2016-18”). The amendments in this update require that amounts generally described as restricted cash and restricted cash equivalents be included within cash and cash equivalents when reconciling the beginning-of-period and end-of-period total amounts shown on the statement of cash flows. ASU 2016-18 became effective January 1, 2018. As a result of adopting ASU 2016-18, the Company includes its restricted cash balance in the cash and cash equivalents reconciliation of operating, investing and financing activities. The following table provides a reconciliation of cash, cash equivalents, and restricted cash within the consolidated balance sheet that sum to the total of the same such amounts shown in the statement of cash flows.
In May 2017, the FASB issued ASU 2017-09, Compensation-Stock Compensation (Topic 718) Scope of Modification Accounting (“ASU 2017-09”). ASU 2017-09 provides clarification on when modification accounting should be used for changes to the terms or conditions of a share-based payment award. The amendments in ASU 2017-09 are effective for all entities for annual periods, and interim periods within those annual periods, beginning after December 15, 2017, with early adoption permitted, applied prospectively to an award modified on or after the adoption date. This ASU does not change the accounting for modifications but clarifies that modification accounting guidance should only be applied if there is a change to the value, vesting conditions, or award classification and would not be required if the changes are considered non-substantive. The Company adopted this ASU as of January 1, 2018 and it did not have a material impact on its condensed consolidated financial statements. Accounting Standards Updates, Recently Issued—In June 2018, the FASB issued ASU No. 2018-07, Compensation-Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting (“ASU 2018-07”). ASU 2018-07 amends the FASB Accounting Standards Codification (“ASC”) to expand the scope of FASB ASC Topic 718, Compensation-Stock Compensation, to include accounting for share-based payment transactions for acquiring goods and services from non-employees. The amendments in ASU 2018-07 are effective for all entities for annual periods, and interim periods within those annual periods, beginning after December 15, 2018. Early adoption is permitted. The Company is currently assessing the potential impact of adopting ASU 2018-07 on its financial statements and related disclosures In February 2016, the FASB issued ASU 2016-02, Leases (“ASU 2016-02”). ASU 2016-02 supersedes the lease guidance under FASB ASC Topic 840, Leases, resulting in the creation of FASB ASC Topic 842, Leases. ASU 2016-02 requires a lessee to recognize in the statement of financial position a liability to make lease payments and a right-of-use asset representing its right to use the underlying asset for the lease term for both finance and operating leases. In July 2018, the FASB issued ASU 2018-10, Codification Improvements to Topic 842, Leases (“ASU 2018-10”) and ASU No. 2018-11, Target Improvements to Topic 842, Leases (“ASU 2018-11”). The amendments in ASU 2018-10 provide additional clarification and implementation guidance on certain aspects of ASU 2016-02 and have the same effective and transition requirements as ASU 2016-02. ASU 2018-11 gives entities the option to not provide comparative period financial statements and instead apply the transition requirements as of the effective date of the new standard. ASU 2016-02, ASU 2018-10 and ASU 2018-11 are effective for fiscal years, and interim periods within those years, beginning after December 15, 2018. Early adoption is permitted. The Company plans to adopt the new standard using the optional method under ASU 2018-11 and is currently working through lease contract scoping, design and implementation of transition related controls, and finalization of accounting elections. The Company is still assessing the impact that this standard will have on its condensed consolidated financial statements and related disclosures; however, it anticipates that the new standard will result in the Company recording additional right of use assets and corresponding liabilities on its consolidated balance sheet. In July 2018, the FASB issued ASU 2018-09, Codification Improvements, or (“ASU 2018-09”). This amendment makes changes to a variety of topics to clarify, correct errors in, or make minor improvements to the ASC. The majority of the amendments in ASU 2018-09 will be effective for the Company in annual periods beginning after December 15, 2018. The Company is currently evaluating the effects the adoption of ASU 2018-09 will have on its consolidated financial statements, results of operations and cash flows. In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement - Disclosure Framework-Changes to the Disclosure Requirement for Fair Value Measurement, or (“ASU 2018-13”). The amendments in this ASU 2018-13 modify the disclosure requirements on fair value measurements in Topic 820, Fair Value Measurement, based on the concepts in the Concepts Statement, including the consideration of costs and benefits. The amendment under ASU 2018-13 are effective for interim and annual fiscal periods beginning after December 15, 2019, with early adoption permitted. The Company is currently evaluating the effects the adoption of ASU 2018-13 will have on its consolidated financial statements and related disclosures. In August 2018, the FASB issued ASU 2018-15, Intangible-Goodwill and Other Internal-Use Software (Subtopic 350-40 (“ASU 2018-15”). ASU 2018-15 updates guidance regarding accounting for a cloud computing arrangement that is a service contract. The amendments under ASU 2018-15 are effective for interim and annual fiscal periods beginning after December 15, 2019, with early adoption permitted. The Company does not expect the adoption of ASU 2018-15 to have a material impact on its results of operations, financial position or cash flows. On August 17, 2018, the SEC issued an amendment to Rule 3-04 of Regulation S-X, which extended the annual disclosure requirement of reporting changes in stockholders’ equity to interim periods. Such disclosures are to be provided in a note to the financial statements or in a separate financial statement and requires both the year-to-date information and subtotals for each interim period. On September 25, 2018, the SEC issued guidance under a Compliance and Disclosure Interpretation (C&DI 105.09) to clarify the effective date of the requirement. Under the guidance in C&DI 105.09, the Company plans to implement this updated disclosure requirement beginning with the first quarter 2019 Form 10-Q. |
Marketable Securities |
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Investments, Debt and Equity Securities [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Marketable Securities | Marketable Securities Available-for-sale marketable securities and cash and cash equivalents as of September 30, 2018 and December 31, 2017 consist of the following (in thousands):
There were no available-for-sale marketable securities that had been in an unrealized loss position for more than 12 months as of September 30, 2018 or December 31, 2017, respectively. There were 29 marketable securities with an aggregate fair value of $214.4 million in an unrealized loss position for less than 12 months as of September 30, 2018. There were 38 marketable securities with an aggregate fair value of $299.2 million in an unrealized loss position for less than 12 months as of December 31, 2017. The Company considered the decrease in market value for these securities to be primarily attributable to current economic conditions. As it was not more likely than not that the Company would be required to sell these securities before the recovery of their amortized cost basis, which may be at maturity, the Company did not consider these investments to be other-than-temporarily impaired as of September 30, 2018. As of September 30, 2018, the aggregate fair value of marketable securities maturing within one year and after one year through two years was $172.1 million and $42.2 million, respectively. |
Fair Value Measurements |
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Fair Value Disclosures [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fair Value Measurements | Fair Value Measurements The Company determines the fair value of its financial instruments based upon the fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. Below are the three levels of inputs that may be used to measure fair value:
Transfers into or out of any hierarchy level are recognized at the end of the reporting period in which the transfers occurred. There were no material transfers between any levels during the nine months ended September 30, 2018. There were no material transfers between any levels during 2017. The following table summarizes the financial instruments measured at fair value on a recurring basis in the Company’s accompanying condensed consolidated balance sheets as of September 30, 2018 and December 31, 2017 (in thousands):
(1) Fair value is based upon quoted market prices. (2) Fair value is based upon quoted prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active and model-based valuation techniques for which all significant assumptions are observable in the market or can be corroborated by observable market data for substantially the full term of the assets. Inputs are obtained from various sources, including market participants, dealers and brokers. |
Inventory |
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Inventory Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Inventory | Inventory Inventory consisted of the following at September 30, 2018 and December 31, 2017 (in thousands):
Inventory acquired prior to receipt of the marketing approval for TYMLOS, totaling approximately $1.6 million, was expensed as research and development expense as incurred. The Company began to capitalize the costs associated with the production of TYMLOS upon receipt of FDA approval on April 28, 2017. Finished goods manufactured by the Company have a 36-month shelf life from date of manufacture. |
Intangible Assets |
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Goodwill and Intangible Assets Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||
Intangible Assets | Intangible Assets The following table presents intangible assets as of September 30, 2018 (in thousands):
Acquired and in-licensed rights as of September 30, 2018 consist of the €8.0 million (approximately $8.7 million on the date paid) milestone paid to Ipsen, which was triggered by FDA approval of TYMLOS on April 28, 2017. The Company recorded approximately $0.2 million and $0.6 million in amortization expense related to intangible assets, using the straight-line methodology, which is considered the best estimate of economic benefit, during the three and nine months ended September 30, 2018. Estimated future amortization expense for intangible assets as of September 30, 2018 is approximately $0.2 million for the remainder of 2018, and approximately $0.8 million per year over the remaining life. |
Accrued Expenses and Other Current Liabilities |
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Accrued Expenses and Other Current Liabilities | Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consisted of the following for the periods set forth below (in thousands):
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Convertible Notes Payable |
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Debt Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Convertible Notes Payable | Convertible Notes Payable On August 14, 2017, in a registered underwritten public offering, the Company issued $300 million aggregate principal amount of 3% Convertible Senior Notes due September 1, 2024 (the “Convertible Notes”). In addition, on September 12, 2017, the Company issued an additional $5.0 million principal amount of Convertible Notes pursuant to the exercise of an over-allotment option granted to the underwriters in the offering. In accordance with accounting guidance for debt with conversion and other options, the Company separately accounted for the liability component (“Liability Component”) and embedded conversion option (the “Equity Component”) of the Convertible Notes by allocating the proceeds between the Liability Component and the Equity Component, due to the Company’s ability to settle the Convertible Notes in cash, common stock or a combination of cash and common stock, at its option. In connection with the issuance of the Convertible Notes, the Company incurred approximately $9.4 million of debt issuance costs, which primarily consisted of underwriting, legal and other professional fees, and allocated these costs to the Liability and Equity Components based on the allocation of the proceeds. Of the total $9.4 million of debt issuance costs, $4.3 million was allocated to the Equity Component and recorded as a reduction to additional paid-in capital and $5.1 million was allocated to the liability component and is now recorded as a reduction of the Convertible Notes in the Company’s condensed consolidated balance sheet. The portion allocated to the liability component is amortized to interest expense using the effective interest method over seven years. The Convertible Notes are senior unsecured obligations of the Company and bear interest at a rate of 3.00% per annum, payable semi-annually in arrears on March 1 and September 1, beginning on March 1, 2018. Upon conversion, the Convertible Notes will be convertible into cash, shares of the Company’s common stock or a combination of cash and shares of the Company’s common stock, at the Company’s election. Prior to December 31, 2017, the Convertible Notes were not convertible except in connection with a make whole fundamental change, as defined in the respective indentures. The Convertible Notes will be subject to redemption at the Company’s option, on or after September 1, 2021, in whole or in part, if the conditions described below are satisfied. The Convertible Notes will mature on September 1, 2024, unless earlier converted, redeemed or repurchased in accordance with their terms. Subject to satisfaction of certain conditions and during the periods described below, the Convertible Notes may be converted at an initial conversion rate of 20.4891 shares of common stock per $1,000 principal amount of the Convertible Notes (equivalent to an initial conversion price of approximately $48.81 per share of common stock). Holders of the Convertible Notes may convert all or any portion of their notes, in multiples of $1,000 principal amount, at their option at any time prior to the close of business on the business day immediately preceding June 1, 2024 only under the following circumstances:
As of September 30, 2018, none of the above circumstances had occurred and as such, the Convertible Notes may not be converted. Prior to September 1, 2021, the Company may not redeem the Convertible Notes. On or after September 1, 2021, the Company may redeem for cash all or part of the Convertible Notes if the last reported sale price of the Company’s common stock equals or exceeds 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30-consecutive trading day period ending within five trading days prior to the date on which the Company provides notice of the redemption. The redemption price will be the principal amount of the Convertible Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date. In addition, calling any Convertible Note for redemption will constitute a make-whole fundamental change with respect to that Convertible Note, in which case the conversion rate applicable to the conversion of that Convertible Note, if it is converted in connection with the redemption, will be increased in certain circumstances. The initial carrying amount of the Liability Component of $166.3 million was calculated by measuring the fair value of a similar liability that does not have an associated convertible feature. The allocation was performed in a manner that reflected the Company's non-convertible debt borrowing rate for similar debt. The Equity Component of the Convertible Notes of $138.7 million was recognized as a debt discount and represents the difference between the proceeds from the issuance of the Convertible Notes of $305.0 million and the fair value of the Liability of the Convertible Notes of approximately $166.3 million on their respective dates of issuance. The excess of the principal amount of the Liability Component over its carrying amount (the “Debt Discount”) is amortized to interest expense using the effective interest method over seven years. The Equity Component is not remeasured as long as it continues to meet the conditions for equity classification. In connection with issuance of the Convertible Notes, the Company also incurred certain offering costs directly attributable to the offering. Such costs are deferred and amortized over the term of the debt to interest expense using the effective interest method. A portion of the deferred financing costs incurred in connection with the Convertible Notes was deemed to relate to the Equity Component and was allocated to additional paid-in capital. The outstanding balances of the Convertible Notes as of September 30, 2018 consisted of the following (in thousands):
The Company determined the expected life of the Convertible Notes was equal to its seven-year term. The effective interest rate on the Liability Components of the Convertible Notes for the period from the date of issuance through September 30, 2018 was 13.04%. As of September 30, 2018, the “if-converted value” did not exceed the remaining principal amount of the Convertible Notes. The fair values of the Convertible Notes are based on data from readily available pricing sources which utilize market observable inputs and other characteristics for similar types of instruments, and, therefore, the Convertible Notes are classified within Level 2 in the fair value hierarchy. The fair value of the Convertible Notes, which differs from their carrying value, is influenced by interest rates, the Company’s stock price and stock price volatility. The estimated fair value of the Convertible Notes as of September 30, 2018 was approximately $234.0 million. The following table sets forth total interest expense recognized related to the Convertible Notes during the three and nine months ended September 30, 2018 and 2017 (in thousands):
Future minimum payments on the Company's long-term debt as of September 30, 2018 are as follows (in thousands):
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Stock-Based Compensation |
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Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock-Based Compensation | Stock-Based Compensation Stock Options A summary of stock option activity during the nine months ended September 30, 2018 is as follows (in thousands, except for per share amounts):
The weighted-average grant-date fair value per share of options granted during the three and nine months ended September 30, 2018 was $12.86 and $19.07, respectively. As of September 30, 2018, there was approximately $49.3 million of total unrecognized compensation expense related to unvested stock options, which is expected to be recognized over a weighted-average period of approximately 2.64 years. Restricted Stock Units A summary of RSU activity during the nine months ended September 30, 2018 is as follows (in thousands, except for per share amounts):
As of September 30, 2018, there was approximately $7.3 million of total unrecognized compensation expense related to unvested RSUs, which is expected to be recognized over a weighted-average period of approximately 2.84 years. Employee Stock Purchase Plan In September 2016, the Company initiated the first offering period under the Company's 2016 Employee Stock Purchase Plan (the “ESPP”), pursuant to which eligible employees may purchase shares of the Company’s common stock on the last day of each predetermined six-month offering period at 85% of the lower of the fair market value per share at the beginning or end of the applicable offering period. The offering periods run from March 1 through August 31 and from September 1 through February 28 (or February 29, in a leap year) of each year. As of September 30, 2018, the Company had recorded a liability of $0.2 million related to its ESPP obligations. In accordance with the terms of its ESPP, the Company recorded stock-based compensation expense of $0.2 million and $0.6 million for the three and nine-month periods ended September 30, 2018, respectively. |
Product Revenue Reserves and Allowances |
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Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Product Revenue Reserves and Allowances | Product Revenue Reserves and Allowances To date, the Company’s only source of product revenue has been from the U.S. sales of TYMLOS, which it began shipping to customers in May 2017. The following table summarizes activity in each of the product revenue allowance and reserve categories for the nine months ended September 30, 2018 and 2017 (in thousands):
Chargebacks, discounts, fees, and returns are recorded as reductions of trade receivables, net on the condensed consolidated balance sheets. Government and other rebates are recorded as a component of accrued expenses and other current liabilities on the condensed consolidated balance sheets. The total provision related to sales for 2018 of $25.3 million is comprised of $6.1 million, $8.6 million, and $10.6 million, respectively, for activity during the quarters ended March 31, June 30, and September 30, 2018. The total adjustments related to prior period sales in 2018 of $293 thousand is comprised of $245 thousand, $(29) thousand, and $77 thousand, respectively, for the quarters ended March 31, June 30, and September 30, 2018. The total credits and payments made for 2018 of $18.5 million is comprised of $3.0 million, $6.7 million, and $8.8 million, respectively, for activity during the quarters ended March 31, June 30, and September 30, 2018. |
Net Loss Per Share |
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Net Loss Per Share | Net Loss Per Share Basic and diluted net loss per share for the periods set forth below is calculated as follows (in thousands, except share and per share amounts):
The following potentially dilutive securities, prior to the use of the treasury stock method, have been excluded from the computation of diluted weighted-average shares outstanding, as they would be anti-dilutive. For the three and nine months ended September 30, 2018 and 2017, respectively, all the Company’s options to purchase common stock, warrants, and restricted stock units outstanding were assumed to be anti-dilutive as earnings attributable to common stockholders was in a loss position.
The Company has the option to settle the conversion obligation for the Convertible Notes in cash, shares or any combination of the two. As the Convertible Notes are not convertible as of September 30, 2018, they are not participating securities and they will not have an impact on the calculation of basic earnings or loss per share. Based on the Company's net loss position, there is no impact on the calculation of dilutive loss per share during the three and nine-month periods ended September 30, 2018 and 2017, respectively. |
License Agreements |
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Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
License Agreements | License Agreements 3M In February 2018, the Company entered into a Scale-Up And Commercial Supply Agreement (the “Supply Agreement”) with 3M Company and 3M Innovative Properties Company (collectively with 3M Company, “3M”), pursuant to which 3M has agreed to exclusively manufacture Phase 3 and global commercial supplies of an abaloparatide-coated transdermal patch product (“Product”) and associated applicator devices (“Applicator”). Under the Supply Agreement, 3M will manufacture Product and Applicator for the Company according to agreed-upon specifications in sufficient quantities to meet the Company’s projected supply requirements. 3M will manufacture commercial supplies of Product at unit prices that decrease with an increase in the quantity the Company orders. The Company will pay 3M a mid-to-low single-digit royalty on worldwide net sales of Product and reimburse 3M for certain capital expenditures incurred to establish commercial supply of Product. The Company is responsible for providing, at its expense, supplies of abaloparatide drug substance to be used in manufacturing Product. During the term of the Supply Agreement, 3M and the Company have agreed to work exclusively with each other with respect to the delivery of abaloparatide, parathyroid hormone (“PTH”), and/or PTH related proteins via active transdermal, intradermal, or microneedle technology. In October 2018, the Company committed to fund 3M's purchase of capital equipment totaling approximately $9.6 million in preparation for manufacturing Phase 3 and potential commercial supplies of Product. Milestone payments for the equipment are expected to be made between the fourth quarter of 2018 and the third quarter of 2020. The initial term of the Supply Agreement began on its effective date, February 27, 2018, and will continue for five years after the first commercial sale of Product. The Supply Agreement then automatically renews for successive three-year terms, unless earlier terminated pursuant to its terms or upon either party’s notice of termination to the other 24 months prior to the end of the then-current term. The Supply Agreement may be terminated by either party upon an uncured material breach of its terms by the other party, or due to the other party’s bankruptcy, insolvency, or dissolution. The Company may terminate the Supply Agreement upon the occurrence of certain events, including for certain clinical, technical, or commercial reasons impacting Product, if it is unable to obtain U.S. regulatory approval for Product within a certain time period, or if it ceases development or commercialization of Product. 3M may terminate the Supply Agreement upon the occurrence of certain events, including if there are certain safety issues related to Product, if the Company is unable to obtain U.S. regulatory approval for Product within a certain time period, or if the Company fails to order Product for a certain period of time after commercial launch of the Product in the U.S. Upon certain events of termination, 3M is required to transfer the manufacturing processes for Product and Applicator to the Company or a mutually agreeable third party and continue supplying Product and Applicator for a period of time pursuant to the Company’s projected supply requirements. In June 2009, the Company entered into a Development and Clinical Supplies Agreement with 3M, as amended (the “Development Agreement”), under which Product and Applicator development activities occur and 3M has manufactured phase 1 and 2 clinical trial supplies on an exclusive basis. The term of the Development Agreement runs until June 2019 and then automatically renews for additional one-year terms, unless earlier terminated, until the earliest of (i) the expiration or termination of the Supply Agreement, (ii) the mutual written agreement of the parties, or (iii) prior written notice by either party to the other party at least ninety days prior to the end of the then-current term of the Development Agreement that such party declines to extend the term. Either party may terminate the agreement in the event of an uncured material breach by the other party. The Company pays 3M for services delivered pursuant to the agreement on a fee-for-service or a fee-for-deliverable basis as specified in the agreement. The Company has paid 3M approximately $24.0 million, in the aggregate, through September 30, 2018 with respect to services and deliverables delivered pursuant to the Development Agreement. Ipsen In September 2005, the Company entered into a license agreement (the “License Agreement”), as amended, with an affiliate of Ipsen Pharma SAS (“Ipsen”) under which the Company exclusively licensed certain Ipsen compound technology and related patents covering abaloparatide to research, develop, manufacture, and commercialize certain compounds and related products in all countries, except Japan (where the Company has an option to negotiate a co-promotion agreement for abaloparatide-SC) and France (where the Company’s commercialization rights were subject to certain co-marketing and co-promotion rights exercisable by Ipsen, provided that certain conditions included in the License Agreement were met). The Company believes that Ipsen's co-marketing and co-promotion rights in France have permanently expired. Ipsen also granted the Company an exclusive right and license under the Ipsen compound technology and related patents to make, and have made, compounds or products in Japan. Ipsen further granted the Company an exclusive right and license under certain Ipsen formulation technology and related patents solely for purposes of enabling the Company to develop, manufacture, and commercialize compounds and products covered by the compound technology license in all countries, except Japan and France (as discussed above). In consideration for these rights, to date, the Company has made nonrefundable, non-creditable payments in the aggregate of $13.0 million to Ipsen, including payment in recognition of certain milestones having been achieved through September 30, 2018. The License Agreement provides for further payments upon the achievement of certain future regulatory and commercial milestones. Total additional milestone payments that could be payable under the agreement are €24.0 million (approximately $28.0 million). In connection with the FDA's approval of TYMLOS in April 2017, the Company paid Ipsen a milestone of €8.0 million (approximately $8.7 million on the date paid) under the License Agreement, which the Company recorded as an intangible asset within the condensed consolidated balance sheet and will amortize over the remaining patent life or the estimated useful life of the underlying product. The agreement also provides that the Company will pay to Ipsen a fixed five percent royalty based on net sales of the product by the Company or its sublicensees on a country-by-country basis until the later of the last to expire of the licensed patents or for a period of 10 years after the first commercial sale in such country. The royalty expense was $1.4 million and $3.2 million for the three and nine months ended September 30, 2018, respectively, and is included within cost of sales. The date of the last to expire of the abaloparatide patents licensed from or co-owned with Ipsen, barring any extension thereof, is expected to be March 26, 2028. If the Company sublicenses abaloparatide to a third party, then the agreement provides that the Company would pay Ipsen a percentage of certain payments received from such sublicensee (in lieu of milestone payments not achieved at the time of such sublicense). The applicable percentage is in the low double-digit range. In addition, if the Company or its sublicensees commercialize a product that includes a compound discovered by it based on or derived from confidential Ipsen know-how, then the agreement provides that the Company would pay to Ipsen a fixed low single-digit royalty on net sales of such product on a country-by-country basis until the later of the last to expire of licensed patents that cover such product or for a period of 10 years after the first commercial sale of such product in such country. The License Agreement expires on a country-by-country basis on the later of (1) the date the last remaining valid claim in the licensed patents expires in that country, or (2) a period of 10 years after the first commercial sale of the licensed products in such country, unless it is sooner terminated in accordance with its terms. Pursuant to a final decision in arbitration proceedings with Ipsen in connection with the License Agreement, the Company is obligated to pay Ipsen $5.0 million if abaloparatide receives marketing approval in Japan and a fixed mid single-digit royalty based on net sales of abaloparatide in Japan. Eisai Co. Ltd. In June 2006, the Company entered into a license agreement (the “Eisai Agreement”), with Eisai Co. Ltd. (“Eisai”). Under the Eisai Agreement, Eisai granted to the Company an exclusive right and license to research, develop, manufacture and commercialize elacestrant (RAD1901) and related products from Eisai in all countries, except Japan. In consideration for the rights to elacestrant, the Company paid Eisai an initial license fee of $0.5 million, which was expensed during 2006. In March 2015, the Company entered into an amendment to the Eisai Agreement (the “Eisai Amendment”) in which Eisai granted to the Company the exclusive right and license to research, develop, manufacture and commercialize elacestrant in Japan. In consideration for the rights to elacestrant in Japan, the Company paid Eisai an initial license fee of $0.4 million upon execution of the Eisai Amendment, which was recognized as research and development expense in 2015. The Eisai Agreement, as amended, also provides for additional payments of up to $22.3 million, payable upon the achievement of certain clinical and regulatory milestones. To date, the Company has paid Eisai approximately $1.0 million in connection with the achievement of certain milestones. Under the Eisai Agreement, as amended, should a product covered by the licensed technology be commercialized, the Company will be obligated to pay to Eisai royalties in a variable mid-single-digit range based on net sales of the product on a country-by-country basis. The royalty rate will be reduced, on a country-by-country basis, at such time as the last remaining valid claim in the licensed patents expires, lapses, or is invalidated and the product is not covered by data protection clauses. In addition, the royalty rate will be reduced, on a country-by-country basis, if, in addition to the conditions specified in the previous sentence, sales of lawful generic versions of such product account for more than a specified minimum percentage of the total sales of all products that contain the licensed compound during a calendar quarter. The latest licensed patent is expected to expire, barring any extension thereof, on August 18, 2026. The Eisai Agreement, as amended, also grants the Company the right to grant sublicenses with prior written approval from Eisai. If the Company sublicenses the licensed technology to a third party, the Company will be obligated to pay Eisai, in addition to the milestones referenced above, a fixed low double-digit percentage of certain fees received from such sublicensee and royalties in the low single-digit range based on net sales of the sublicensee. The Eisai Agreement expires on a country-by-country basis on the later of (1) the date the last remaining valid claim in the licensed patents expires, lapses or is invalidated in that country, the product is not covered by data protection clauses, and the sales of lawful generic versions of the product account for more than a specified percentage of the total sales of all pharmaceutical products containing the licensed compound in that country; or (2) a period of 10 years after the first commercial sale of the licensed products in such country, unless it is sooner terminated. Duke University In December 2017, the Company entered into a patent license agreement (the “Duke Agreement”) with Duke University (“Duke”). Under the Duke Agreement, the Company acquired an exclusive worldwide license to certain Duke patents associated with elacestrant related to the use of elacestrant in the treatment of breast cancer as a monotherapy and in a combination therapy (collectively the “Duke Patents”). In consideration for these rights, the Company incurred non-refundable, non-creditable obligations to pay Duke an aggregate of $1.3 million, which were expensed as research and development costs during 2017. The Duke Agreement provides for additional payments upon the achievement of certain regulatory and commercial milestones totaling up to $3.8 million. To date, the Company has paid Duke approximately $0.5 million in connection with the achievement of certain milestones. The agreement provides that the Company would pay Duke a fixed low single-digit royalty based on net sales of a licensed product, on a country-by-country basis, beginning in August 2029 and ending upon expiration of the last licensed patent rights to expire in a country. The latest licensed patent is expected to expire, barring any extension thereof, on October 10, 2034. If the Company sublicenses the Duke Patents to a third party, the agreement provides that the Company will pay Duke a percentage of certain payments received by it from such sublicensee(s). The applicable percentage is in the high single-digit range on certain payments received in excess of a pre-specified amount. The Duke Agreement may be terminated by either party upon an uncured material breach of the agreement by the other party. The Company may terminate the agreement upon 60 days written notice to Duke, if the Company suspends its manufacture, use and sale of the licensed products. Teijin Limited In July 2017, the Company entered into a license and development agreement (the “Teijin Agreement”) with Teijin Limited (“Teijin”) for abaloparatide-SC in Japan. Pursuant to the Teijin Agreement, the Company granted Teijin: (i) an exclusive payment-bearing license under certain of the Company’s intellectual property to develop and commercialize abaloparatide-SC in Japan, (ii) a non-exclusive payment-bearing license under certain of the Company’s intellectual property to manufacture abaloparatide-SC for commercial supply in Japan, (iii) a right of reference to certain of the Company’s regulatory data related to abaloparatide-SC for purposes of developing, manufacturing and commercializing abaloparatide-SC in Japan, (iv) a manufacture transfer package, upon Teijin’s request, consisting of information and the Company’s know-how that is necessary for the manufacture of active pharmaceutical ingredient and abaloparatide-SC, (v) a right to request that the Company manufacture (or arrange for a third party to manufacture) and supply (or arrange for a third party to supply) the active pharmaceutical ingredient for the clinical supply of abaloparatide-SC in sufficient quantities to enable Teijin to conduct its clinical trials in Japan, and (vi) a right to request that the Company arrange for Teijin to directly enter into commercial supply agreements with the Company's existing contract manufacturers on the same pricing terms and on substantially similar commercial terms to those set forth in the Company's existing agreements with such contract manufacturers. In consideration for these rights, the Company received an upfront payment of $10.0 million, and may receive further payments upon the achievement of certain regulatory and sales milestones, as well as a fixed low double-digit royalty based on net sales of abaloparatide-SC in Japan during the royalty term, as defined below. In addition, the Company has an option to negotiate a co-promotion agreement with Teijin for abaloparatide-SC in Japan upon commercialization. Pursuant to the Teijin Agreement, the parties may further collaborate on new indications for abaloparatide-SC, and the Company also maintains full global rights to its development program for abaloparatide-patch, which is not part of the Teijin Agreement. Unless earlier terminated, the Teijin Agreement expires on the later of the (i) date on which the use, sale or importation of abaloparatide-SC is no longer covered by a valid claim under the Company’s patent rights licensed to Teijin in Japan, (ii) expiration of marketing or data exclusivity for abaloparatide-SC in Japan, or (iii) 10th anniversary of the first commercial sale of abaloparatide-SC in Japan. Upon execution of the Teijin Agreement, the transaction price included only the $10.0 million up-front payment owed to the Company. The Company received this amount in October 2017. As referenced above, the Company may receive further payments upon the achievement of certain regulatory and sales milestones, totaling up to $40.0 million, as well as a fixed low double-digit royalty based on net sales of abaloparatide-SC in Japan during the royalty term. |
Income Taxes |
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Sep. 30, 2018 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes The Company did not record a federal or state income tax provision or benefit for the three and nine months ended September 30, 2018 and 2017 due to the expected loss before income taxes to be incurred for the years ended December 31, 2018 and 2017, as well as the Company’s continued maintenance of a full valuation allowance against its net deferred tax assets. On December 22, 2017, the SEC staff issued Staff Accounting Bulletin No. 118 (“SAB 118”) to address the application of U.S. GAAP in situations when a registrant does not have the necessary information available, prepared, or analyzed (including computations) in reasonable detail to complete the accounting for certain income tax effects of the U.S. Tax Cuts and Jobs Act (the “Tax Reform Act”), which was enacted in December 2017. The Company has recognized the provisional tax impacts related to the revaluation of the deferred tax assets and liabilities and included these amounts in its consolidated financial statements for the year ended December 31, 2017. The ultimate impact may differ from these provisional amounts due to, among other things, additional analysis, changes in interpretations and assumptions the Company has made, additional regulatory guidance that may be issued, and actions the Company may take as a result of the Tax Reform Act. The accounting was completed when the Company's 2017 U.S. corporate income tax return was filed in October 2018. |
Commitments and Contingencies |
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Sep. 30, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Litigation The Company may be subject to legal proceedings and claims which arise in the ordinary course of its business. In the Company's opinion, the ultimate resolution of these matters is not expected to have a material effect on its consolidated financial statements. The Company records a liability in its consolidated financial statements for these matters when a loss is known or considered probable and the amount can be reasonably estimated. The Company reviews these estimates each accounting period as additional information is known and adjusts the loss provision when appropriate. If a matter is both probable to result in a liability and the amounts of loss can be reasonably estimated, the Company estimates and discloses the possible loss or range of loss to the extent necessary to make the consolidated financial statements not misleading. If the loss is not probable or cannot be reasonably estimated, a liability is not recorded in its consolidated financial statements. As of September 30, 2018, the Company was not party to any significant litigation. Manufacturing Agreements In June 2016, the Company entered into a Supply Agreement with Ypsomed AG (“Ypsomed”), pursuant to which Ypsomed agreed to supply commercial and clinical supplies of a disposable pen injection device customized for subcutaneous injection of abaloparatide, the active pharmaceutical ingredient (“API”) for TYMLOS. The Company agreed to purchase a minimum number of devices at prices per device that decrease with an increase in quantity supplied. In addition, the Company has made milestone payments for Ypsomed’s capital developments in connection with the initiation of the commercial supply of the device and paid a one-time capacity fee. All costs and payments under the agreement are delineated in Swiss Francs. The agreement has an initial term of three years, which began on June 1, 2017, after which it automatically renews for two-year terms unless either party terminates the agreement upon 18 months' notice prior to the end of the then-current term. The Company agreed to purchase the devices at prices that decrease based on the quantity ordered, subject to an annual increase by Ypsomed and to minimum annual quantity requirements over the initial three-year term of the agreement. The Company is required to purchase a minimum number of batches equal to approximately CHF 0.5 million (approximately $0.5 million) per year and CHF 2.9 million (approximately $3.0 million) in total, subject to any annual price adjustments, during the initial term. In June 2016, the Company entered into a Commercial Supply Agreement with Vetter Pharma International GmbH (“Vetter”), pursuant to which Vetter has agreed to formulate the finished abaloparatide-SC drug product containing abaloparatide API, to fill cartridges with the drug product, to assemble the pen delivery device, and to package the pen for commercial distribution. The Company agreed to purchase the cartridges and pens in specified batch sizes at a price per unit. For labeling and packaging services, the Company agreed to pay a per unit price dependent upon the number of pens loaded with cartridges that are labeled and packaged. These prices are subject to an annual price adjustment. The agreement has an initial term of five years, which began on January 1, 2016, after which, it automatically renews for two-year terms unless either party notifies the other party two years before the end of the then-current term that it does not intend to renew. In July 2016, the Company entered into a Manufacturing Services Agreement with Polypeptide Laboratories Holding AB (“PPL”), as successor-in-interest to Lonza Group Ltd., pursuant to which PPL agreed to manufacture the commercial and clinical supplies of the API for abaloparatide. The Company agreed to purchase the API in batches at a price per gram in euros, subject to an annual increase by PPL. The agreement has an initial term of six years, which began on June 28, 2016, after which, it automatically renews for three-year terms unless either party provides notice of non-renewal 24 months before the end of the then-current term. The Company is also required to purchase a minimum number of batches annually, equal to approximately €2.9 million (approximately $3.4 million) per year and approximately €16.1 million (approximately $18.7 million) in total, subject to any annual price adjustments, during the initial term. Restructuring In March 2018, the Company implemented a restructuring plan to consolidate operations into its two main offices in Waltham, Massachusetts and Wayne, Pennsylvania to achieve operational efficiencies. As part of that effort, the Company will shut down its Parsippany, New Jersey office. Costs incurred in connection with the restructuring comprise one-time benefits to employees who are involuntarily terminated, costs related to the early termination of contracts, and retention costs for certain employees who will continue to work remotely for the Company after the Parsippany office is closed. Employee termination and retention related costs are generally recognized ratably over the future service period and contract termination costs are generally recognized as of the cease-use date. During the nine months ended September 30, 2018, the Company incurred $1.5 million of employee termination and retention costs, with related cash payments to be made through the first quarter of 2019. In June 2018, the Company implemented a restructuring plan designed to increase the impact and efficiency of its field sales by re-allocating commercial resources across certain territories. Costs incurred in connection with the restructuring comprise one-time benefits to employees who are involuntarily terminated. During the nine months ended September 30, 2018, the Company incurred $0.5 million of employee termination costs, and made related cash payments in the third quarter of 2018. |
Basis of Presentation and Significant Accounting Policies (Policies) |
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Accounting Policies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Basis of Presentation and Significant Accounting Policies | Basis of Presentation—The accompanying unaudited condensed consolidated financial statements and the related disclosures of the Company have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) for interim financial reporting and as required by Regulation S-X, Rule 10-01. Accordingly, they do not include all the information and footnotes required by U.S. GAAP for complete financial statements. In the opinion of management, all adjustments (including those which are normal and recurring) considered necessary for a fair presentation of the interim financial information have been included. When preparing financial statements in conformity with U.S. GAAP, the Company must make estimates and assumptions that affect the reported amounts of assets, liabilities, expenses and related disclosures at the date of the financial statements. Actual results could differ from those estimates. Additionally, operating results for the nine months ended September 30, 2018 are not necessarily indicative of the results that may be expected for any other interim period or for the fiscal year ending December 31, 2018. Subsequent events have been evaluated up to the date of issuance of these financial statements. These interim condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes, which are contained in the Company's Annual Report on Form 10-K for the year ended December 31, 2017 (“2017 Form 10-K”), filed with the Securities and Exchange Commission (“SEC”) on March 1, 2018. Certain prior period amounts have been reclassified to conform to the current period presentation. Significant Accounting Policies—The significant accounting policies identified in the Company’s 2017 Form 10-K that require the Company to make estimates and assumptions include: revenue recognition, inventory obsolescence, long-lived assets and intangible assets, accounting for stock-based compensation, contingencies, tax valuation reserves, fair value measures, and accrued expenses. There were no changes to significant accounting policies during the nine months ended September 30, 2018, except for the adoption of three Accounting Standards Updates (“ASU”) issued by the Financial Accounting Standards Board (“FASB”), which are detailed below. |
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Accounting Standards Updates, Recently Adopted | Accounting Standards Updates, Recently Adopted—In August 2016, the FASB issued ASU No. 2016-15, Classification of Certain Cash Receipts and Cash Payments (“ASU 2016-15”). ASU 2016-15 addresses eight specific cash flow issues with the objective of reducing the existing diversity in practice. ASU 2016-15 is effective for fiscal years, and interim periods within those years, beginning after December 15, 2017. The Company adopted this ASU as of January 1, 2018 and it did not have a material impact on its condensed consolidated financial statements. In November 2016, the FASB issued ASU 2016-18, Statement of Cash Flows: Restricted Cash (“ASU 2016-18”). The amendments in this update require that amounts generally described as restricted cash and restricted cash equivalents be included within cash and cash equivalents when reconciling the beginning-of-period and end-of-period total amounts shown on the statement of cash flows. ASU 2016-18 became effective January 1, 2018. As a result of adopting ASU 2016-18, the Company includes its restricted cash balance in the cash and cash equivalents reconciliation of operating, investing and financing activities. The following table provides a reconciliation of cash, cash equivalents, and restricted cash within the consolidated balance sheet that sum to the total of the same such amounts shown in the statement of cash flows.
In May 2017, the FASB issued ASU 2017-09, Compensation-Stock Compensation (Topic 718) Scope of Modification Accounting (“ASU 2017-09”). ASU 2017-09 provides clarification on when modification accounting should be used for changes to the terms or conditions of a share-based payment award. The amendments in ASU 2017-09 are effective for all entities for annual periods, and interim periods within those annual periods, beginning after December 15, 2017, with early adoption permitted, applied prospectively to an award modified on or after the adoption date. This ASU does not change the accounting for modifications but clarifies that modification accounting guidance should only be applied if there is a change to the value, vesting conditions, or award classification and would not be required if the changes are considered non-substantive. The Company adopted this ASU as of January 1, 2018 and it did not have a material impact on its condensed consolidated financial statements. Accounting Standards Updates, Recently Issued—In June 2018, the FASB issued ASU No. 2018-07, Compensation-Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting (“ASU 2018-07”). ASU 2018-07 amends the FASB Accounting Standards Codification (“ASC”) to expand the scope of FASB ASC Topic 718, Compensation-Stock Compensation, to include accounting for share-based payment transactions for acquiring goods and services from non-employees. The amendments in ASU 2018-07 are effective for all entities for annual periods, and interim periods within those annual periods, beginning after December 15, 2018. Early adoption is permitted. The Company is currently assessing the potential impact of adopting ASU 2018-07 on its financial statements and related disclosures In February 2016, the FASB issued ASU 2016-02, Leases (“ASU 2016-02”). ASU 2016-02 supersedes the lease guidance under FASB ASC Topic 840, Leases, resulting in the creation of FASB ASC Topic 842, Leases. ASU 2016-02 requires a lessee to recognize in the statement of financial position a liability to make lease payments and a right-of-use asset representing its right to use the underlying asset for the lease term for both finance and operating leases. |
Basis of Presentation and Significant Accounting Policies (Tables) |
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Accounting Policies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Cash and Cash Equivalents | The following table provides a reconciliation of cash, cash equivalents, and restricted cash within the consolidated balance sheet that sum to the total of the same such amounts shown in the statement of cash flows.
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Marketable Securities (Tables) |
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Investments, Debt and Equity Securities [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of available-for-sale marketable securities and cash and cash equivalents | Available-for-sale marketable securities and cash and cash equivalents as of September 30, 2018 and December 31, 2017 consist of the following (in thousands):
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Fair Value Measurements (Tables) |
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Sep. 30, 2018 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fair Value Disclosures [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of financial instruments measured at fair value on a recurring basis | The following table summarizes the financial instruments measured at fair value on a recurring basis in the Company’s accompanying condensed consolidated balance sheets as of September 30, 2018 and December 31, 2017 (in thousands):
(1) Fair value is based upon quoted market prices. (2) Fair value is based upon quoted prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active and model-based valuation techniques for which all significant assumptions are observable in the market or can be corroborated by observable market data for substantially the full term of the assets. Inputs are obtained from various sources, including market participants, dealers and brokers. |
Inventory (Tables) |
9 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Sep. 30, 2018 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Inventory Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of inventory | Inventory consisted of the following at September 30, 2018 and December 31, 2017 (in thousands):
|
Intangible Assets (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||
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Sep. 30, 2018 | |||||||||||||||||||||||||||||||||||||
Goodwill and Intangible Assets Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||
Schedule of intangible assets | The following table presents intangible assets as of September 30, 2018 (in thousands):
|
Accrued Expenses and Other Current Liabilities (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Sep. 30, 2018 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Payables and Accruals [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of accrued expenses and other current liabilities | Accrued expenses and other current liabilities consisted of the following for the periods set forth below (in thousands):
|
Convertible Notes Payable (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Sep. 30, 2018 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Debt Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of outstanding balances of convertible notes | The outstanding balances of the Convertible Notes as of September 30, 2018 consisted of the following (in thousands):
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Schedule of interest expense recognized related to convertible notes | The following table sets forth total interest expense recognized related to the Convertible Notes during the three and nine months ended September 30, 2018 and 2017 (in thousands):
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Schedule of future minimum payments on long-term debt | Future minimum payments on the Company's long-term debt as of September 30, 2018 are as follows (in thousands):
|
Stock-Based Compensation (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Sep. 30, 2018 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of stock option activity | A summary of stock option activity during the nine months ended September 30, 2018 is as follows (in thousands, except for per share amounts):
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Summary of restricted stock units activity | A summary of RSU activity during the nine months ended September 30, 2018 is as follows (in thousands, except for per share amounts):
|
Product Revenue Reserves and Allowances (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Sep. 30, 2018 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of product revenue allowance and reserve categories | The following table summarizes activity in each of the product revenue allowance and reserve categories for the nine months ended September 30, 2018 and 2017 (in thousands):
|
Net Loss Per Share (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Sep. 30, 2018 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Earnings Per Share [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of basic and diluted net loss per share | Basic and diluted net loss per share for the periods set forth below is calculated as follows (in thousands, except share and per share amounts):
|
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Schedule of potentially dilutive securities excluded from the computation of diluted weighted-average shares outstanding | The following potentially dilutive securities, prior to the use of the treasury stock method, have been excluded from the computation of diluted weighted-average shares outstanding, as they would be anti-dilutive. For the three and nine months ended September 30, 2018 and 2017, respectively, all the Company’s options to purchase common stock, warrants, and restricted stock units outstanding were assumed to be anti-dilutive as earnings attributable to common stockholders was in a loss position.
|
Organization (Details) - USD ($) $ in Thousands |
9 Months Ended | |
---|---|---|
Sep. 30, 2018 |
Dec. 31, 2017 |
|
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Accumulated deficit | $ 1,062,523 | $ 882,284 |
Cash, cash equivalents, marketable securities, and investments | $ 276,900 | |
Minimum | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Cash and cash equivalents, period to support operations | 12 months |
Basis of Presentation and Significant Accounting Policies - Restricted Cash (Details) - USD ($) $ in Thousands |
Sep. 30, 2018 |
Dec. 31, 2017 |
Sep. 30, 2017 |
Dec. 31, 2016 |
---|---|---|---|---|
Accounting Policies [Abstract] | ||||
Cash and cash equivalents | $ 62,014 | $ 118,564 | $ 446,938 | |
Restricted cash | 558 | 47 | ||
Total cash, cash equivalents, and restricted cash shown in the statement of cash flows | $ 62,572 | $ 118,619 | $ 446,985 | $ 258,614 |
Marketable Securities - Narrative (Details) $ in Millions |
Sep. 30, 2018
USD ($)
security
|
Dec. 31, 2017
USD ($)
security
|
---|---|---|
Investments, Debt and Equity Securities [Abstract] | ||
Debt securities held in an unrealized loss position for more than 12 months | security | 0 | 0 |
Debt securities held in an unrealized loss position for less than 12 months | security | 29 | 38 |
Fair value of debt securities in an unrealized loss position for less than 12 months | $ 214.4 | $ 299.2 |
Aggregate fair value of marketable securities maturing within one year | 172.1 | |
Aggregate fair value of marketable securities maturing after one year through two years | $ 42.2 |
Inventory (Details) - USD ($) $ in Thousands |
3 Months Ended | 4 Months Ended | 9 Months Ended | |||
---|---|---|---|---|---|---|
Sep. 30, 2018 |
Sep. 30, 2017 |
Apr. 28, 2017 |
Sep. 30, 2018 |
Sep. 30, 2017 |
Dec. 31, 2017 |
|
Inventory Disclosure [Abstract] | ||||||
Raw materials | $ 4,257 | $ 4,257 | $ 3,852 | |||
Work in process | 636 | 636 | 313 | |||
Finished goods | 653 | 653 | 201 | |||
Total inventories | 5,546 | 5,546 | $ 4,366 | |||
Research and development | $ 26,804 | $ 20,997 | $ 1,600 | $ 75,979 | $ 60,176 | |
Finished goods shelf life | 36 months |
Intangible Assets - Schedule of Intangible Assets (Details) - USD ($) $ in Thousands |
9 Months Ended | |
---|---|---|
Sep. 30, 2018 |
Dec. 31, 2017 |
|
Finite-Lived Intangible Assets, Net [Abstract] | ||
Acquired and in-licensed rights | $ 8,712 | |
Less: accumulated amortization | (1,131) | |
Total intangible asset, net | $ 7,581 | $ 8,180 |
Estimated useful life | 11 years |
Intangible Assets - Narrative (Details) $ in Thousands, € in Millions |
1 Months Ended | 3 Months Ended | 9 Months Ended | |||
---|---|---|---|---|---|---|
Apr. 30, 2017
USD ($)
|
Apr. 30, 2017
EUR (€)
|
Sep. 30, 2018
USD ($)
|
Sep. 30, 2018
USD ($)
|
Sep. 30, 2018
EUR (€)
|
Sep. 30, 2017
USD ($)
|
|
Finite-Lived Intangible Assets [Line Items] | ||||||
Milestone payments that triggered intangible asset recognition | $ 0 | $ 8,712 | ||||
Amortization expense | $ 200 | 600 | ||||
Estimated future amortization expense for intangible assets, remainder of year | 200 | 200 | ||||
Estimated future amortization expense for intangible assets, per year thereafter | $ 800 | 800 | ||||
Collaborative Arrangement | Ipsen | ||||||
Finite-Lived Intangible Assets [Line Items] | ||||||
Milestone payments that triggered intangible asset recognition | $ 8,700 | € 8.0 | $ 8,700 | € 8.0 |
Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands |
Sep. 30, 2018 |
Dec. 31, 2017 |
---|---|---|
Payables and Accruals [Abstract] | ||
Commercial costs and product revenue reserves | $ 13,567 | $ 14,300 |
Research and development costs | 11,212 | 8,406 |
Payroll and employee benefits | 11,619 | 16,934 |
Interest | 763 | 3,482 |
Restructuring costs | 628 | 0 |
Professional fees | 3,875 | 6,295 |
Other current liabilities | 95 | 95 |
Total accrued expenses and other current liabilities | $ 41,759 | $ 49,512 |
Convertible Notes Payable - Summary of Outstanding Balances of Convertible Notes (Details) - USD ($) $ in Thousands |
Sep. 30, 2018 |
Dec. 31, 2017 |
Aug. 14, 2017 |
---|---|---|---|
Debt Instrument [Line Items] | |||
Net carrying amount | $ 176,180 | $ 166,006 | |
Convertible debt | 3.00% Convertible notes | |||
Debt Instrument [Line Items] | |||
Principal | 305,000 | $ 305,000 | |
Less: debt discount and issuance costs, net | (128,820) | ||
Net carrying amount | 176,180 | 166,300 | |
Equity component | $ 134,450 | $ 138,700 |
Convertible Notes Payable - Summary of Total Interest Expense Recognized Related to the Convertible Notes (Details) - Convertible debt - 3.00% Convertible notes - USD ($) $ in Thousands |
3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Sep. 30, 2018 |
Sep. 30, 2017 |
Sep. 30, 2018 |
Sep. 30, 2017 |
|
Debt Instrument [Line Items] | ||||
Contractual interest expense | $ 2,287 | $ 1,195 | $ 6,863 | $ 1,195 |
Amortization of debt discount | 3,379 | 1,568 | 9,804 | 1,568 |
Amortization of debt issuance costs | 127 | 0 | 370 | 0 |
Total interest expense | $ 5,793 | $ 2,763 | $ 17,037 | $ 2,763 |
Convertible Notes Payable - Schedule of Future Minimum Payments on Long-Term Debt (Details) - USD ($) $ in Thousands |
Sep. 30, 2018 |
Dec. 31, 2017 |
Aug. 14, 2017 |
---|---|---|---|
Future Minimum Payments | |||
Long Term Debt | $ 176,180 | $ 166,006 | |
Convertible debt | 3.00% Convertible notes | |||
Future Minimum Payments | |||
2019 | 9,150 | ||
2020 | 9,150 | ||
2021 | 9,150 | ||
2022 | 9,150 | ||
2023 | 9,150 | ||
2024 and Thereafter | 314,150 | ||
Total minimum payments | 359,900 | ||
Less: interest | (54,900) | ||
Less: unamortized discount | (128,820) | ||
Less: current portion | 0 | ||
Long Term Debt | $ 176,180 | $ 166,300 |
Stock Based Compensation - Stock Options and Restricted Stock Units Narrative (Details) $ / shares in Units, $ in Millions |
3 Months Ended | 9 Months Ended |
---|---|---|
Sep. 30, 2018
USD ($)
$ / shares
|
Sep. 30, 2018
USD ($)
$ / shares
|
|
Options to purchase common stock | ||
Stock-based Compensation | ||
Weighted-average grant-date fair value (in dollars per share) | $ / shares | $ 12.86 | $ 19.07 |
Total unrecognized compensation expense | $ 49.3 | $ 49.3 |
Weighted average period over which unrecognized compensation is expected to be recognized | 2 years 234 days | |
RSUs | ||
Stock-based Compensation | ||
Total unrecognized compensation expense | $ 7.3 | $ 7.3 |
Weighted average period over which unrecognized compensation is expected to be recognized | 2 years 307 days |
Stock-Based Compensation - Summary of Restricted Stock Units (Details) - Restricted stock units (RSUs) shares in Thousands |
9 Months Ended |
---|---|
Sep. 30, 2018
$ / shares
shares
| |
RSUs | |
RSUs Outstanding at beginning of period (in shares) | shares | 147 |
Granted (in shares) | shares | 221 |
Vested (in shares) | shares | (24) |
Forfeited (in shares) | shares | (82) |
RSUs Outstanding at end of period (in shares) | shares | 262 |
Weighted- Average Grant Date Fair Value (in dollars per share) | |
RSUs outstanding at the beginning of the period (in dollars per share) | $ / shares | $ 37.00 |
Granted (in dollars per share) | $ / shares | 37.83 |
Exercised (in dollars per share) | $ / shares | 41.37 |
Forfeited (in dollars per share) | $ / shares | 37.37 |
RSUs outstanding at the end of the period (in dollars per share) | $ / shares | $ 36.69 |
Stock-Based Compensation - Employee Stock Purchase Plan Narrative (Details) - Employee Stock Purchase Plan 2016 - USD ($) $ in Millions |
1 Months Ended | 3 Months Ended | 9 Months Ended |
---|---|---|---|
Sep. 30, 2016 |
Sep. 30, 2018 |
Sep. 30, 2018 |
|
Stock-based Compensation | |||
Share-based compensation arrangement by share-based payment award, award vesting rights, offering period | 6 months | ||
Employee stock purchase plan, purchase price of common stock, percent | 85.00% | ||
Employee stock purchase plan obligation | $ 0.2 | $ 0.2 | |
Stock-based compensation expense | $ 0.2 | $ 0.6 |
Product Revenue Reserves and Allowances Product Revenue Reserves and Allowances - Narrative (Details) - Product Revenue Allowance and Reserves - USD ($) $ in Thousands |
3 Months Ended | 9 Months Ended | |||
---|---|---|---|---|---|
Sep. 30, 2018 |
Jun. 30, 2018 |
Mar. 31, 2018 |
Sep. 30, 2018 |
Sep. 30, 2017 |
|
SEC Schedule, 12-09, Valuation and Qualifying Accounts Disclosure [Line Items] | |||||
Provision related to sales in the current year | $ 10,600 | $ 8,600 | $ 6,100 | $ 25,329 | $ 1,443 |
Adjustments related to prior period sales | (77) | 29 | (245) | 293 | 0 |
Credits and payments made | $ (8,838) | $ (6,745) | $ (2,981) | $ 18,464 | $ 0 |
Net Loss Per Share - Basic and Diluted (Details) - USD ($) $ / shares in Units, $ in Thousands |
3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Sep. 30, 2018 |
Sep. 30, 2017 |
Sep. 30, 2018 |
Sep. 30, 2017 |
|
Numerator: | ||||
Net loss | $ (49,802) | $ (57,843) | $ (180,239) | $ (183,220) |
Denominator: | ||||
Weighted-average number of common shares used in loss per share - basic and diluted (in shares) | 45,498,909 | 43,999,451 | 45,291,176 | 43,535,874 |
Loss per share - basic and diluted (in dollars per share) | $ (1.09) | $ (1.31) | $ (3.98) | $ (4.21) |
Commitments and Contingencies - Restructuring (Details) $ in Millions |
9 Months Ended | |
---|---|---|
Mar. 27, 2018
office
|
Sep. 30, 2018
USD ($)
|
|
Restructuring Cost and Reserve [Line Items] | ||
Number of offices consolidated | office | 2 | |
Employee Termination | New Jersey Program | ||
Restructuring Cost and Reserve [Line Items] | ||
Employee termination costs | $ 1.5 | |
Employee Termination | Sales Territory Program | ||
Restructuring Cost and Reserve [Line Items] | ||
Employee termination costs | $ 0.5 |
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