(State or other jurisdiction of | (I.R.S. Employer | |||||||
incorporation or organization) | Identification No.) |
Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||
☒ | Accelerated filer | ☐ | ||||||||||||
Non-accelerated filer | ☐ | Smaller reporting company | ||||||||||||
Emerging growth company |
June 30, 2022 | December 31, 2021 | ||||||||||
(unaudited) | |||||||||||
ASSETS | |||||||||||
Current assets: | |||||||||||
Cash and cash equivalents | $ | $ | |||||||||
Restricted cash | |||||||||||
Accounts receivable, net | |||||||||||
Inventory | |||||||||||
Prepaid expenses | |||||||||||
License receivables | |||||||||||
Other current assets | |||||||||||
Total current assets | |||||||||||
Property and equipment, net | |||||||||||
Intangible assets | |||||||||||
Right of use assets - operating leases | |||||||||||
Other assets | |||||||||||
Total assets | $ | $ | |||||||||
LIABILITIES AND STOCKHOLDERS’ DEFICIT | |||||||||||
Current liabilities: | |||||||||||
Accounts payable | $ | $ | |||||||||
Accrued expenses and other current liabilities | |||||||||||
Operating lease liability, current | |||||||||||
Total current liabilities | |||||||||||
Convertible notes payable | |||||||||||
Term loan | |||||||||||
Operating lease liability, long term | |||||||||||
Total liabilities | |||||||||||
Stockholders’ deficit: | |||||||||||
Common stock, | |||||||||||
Additional paid-in-capital | |||||||||||
Accumulated other comprehensive income | |||||||||||
Accumulated deficit | ( | ( | |||||||||
Total stockholders’ deficit | ( | ( | |||||||||
Total liabilities and stockholders’ deficit | $ | $ |
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||||||||||
REVENUES: | |||||||||||||||||||||||
Product revenue, net | $ | $ | $ | $ | |||||||||||||||||||
License revenue | |||||||||||||||||||||||
Total revenue | |||||||||||||||||||||||
OPERATING EXPENSES: | |||||||||||||||||||||||
Cost of sales - product | |||||||||||||||||||||||
Cost of sales - intangible amortization | |||||||||||||||||||||||
Research and development, net of amounts reimbursable (a) | |||||||||||||||||||||||
Selling, general and administrative | |||||||||||||||||||||||
Loss from operations | ( | ( | ( | ( | |||||||||||||||||||
OTHER INCOME (EXPENSE): | |||||||||||||||||||||||
Other (expense) income | ( | ( | ( | ||||||||||||||||||||
Interest expense | ( | ( | ( | ( | |||||||||||||||||||
Interest income | |||||||||||||||||||||||
Gain on extinguishment of debt | |||||||||||||||||||||||
NET LOSS | $ | ( | $ | ( | $ | ( | $ | ( | |||||||||||||||
OTHER COMPREHENSIVE LOSS: | |||||||||||||||||||||||
Foreign currency | |||||||||||||||||||||||
Unrealized loss from available-for-sale debt securities | ( | ||||||||||||||||||||||
COMPREHENSIVE LOSS | $ | ( | $ | ( | $ | ( | $ | ( | |||||||||||||||
LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS - BASIC AND DILUTED (Note 7) | $ | ( | $ | ( | $ | ( | $ | ( | |||||||||||||||
LOSS PER SHARE: | |||||||||||||||||||||||
Basic and diluted | $ | ( | $ | ( | $ | ( | $ | ( | |||||||||||||||
WEIGHTED AVERAGE SHARES: | |||||||||||||||||||||||
Basic and diluted |
Stockholders’ Deficit | |||||||||||||||||||||||||||||||||||
Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit | Total Stockholders’ Deficit | |||||||||||||||||||||||||||||||
Shares | Amount | Amount | Amount | Amount | Amount | ||||||||||||||||||||||||||||||
Balance at December 31, 2021 | $ | $ | $ | $ | ( | $ | ( | ||||||||||||||||||||||||||||
Net loss | — | — | — | — | ( | ( | |||||||||||||||||||||||||||||
Foreign currency translation adjustment | — | — | — | — | |||||||||||||||||||||||||||||||
Vesting of restricted shares | — | — | — | — | — | ||||||||||||||||||||||||||||||
Share-based compensation expense related to share-based awards for employee stock purchase plan | — | — | — | — | |||||||||||||||||||||||||||||||
Issuance of common stock upon purchase by employee stock purchase plan | — | — | — | ||||||||||||||||||||||||||||||||
Share-based compensation expense | — | — | — | — | |||||||||||||||||||||||||||||||
Balance at March 31, 2022 | 0 | $ | 0 | $ | 0 | $ | 0 | $ | ( | $ | ( | ||||||||||||||||||||||||
Net Loss | — | — | — | — | ( | ( | |||||||||||||||||||||||||||||
Foreign currency translation adjustment | — | — | — | — | |||||||||||||||||||||||||||||||
Vesting of restricted shares | — | — | — | — | — | ||||||||||||||||||||||||||||||
Share-based compensation expense related to share-based awards for employee stock purchase plan | — | — | — | — | |||||||||||||||||||||||||||||||
Issuance of common stock upon purchase by employee stock purchase plan | — | — | — | — | |||||||||||||||||||||||||||||||
Share-based compensation expense | — | — | — | — | |||||||||||||||||||||||||||||||
Balance at June 30, 2022 | $ | $ | $ | $ | ( | $ | ( |
Stockholders’ Deficit | |||||||||||||||||||||||||||||||||||
Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit | Total Stockholders’ Deficit | |||||||||||||||||||||||||||||||
Shares | Amount | Amount | Amount | Amount | Amount | ||||||||||||||||||||||||||||||
Balance at December 31, 2020 | $ | $ | $ | $ | ( | $ | ( | ||||||||||||||||||||||||||||
Net loss | — | — | — | — | ( | ( | |||||||||||||||||||||||||||||
— | — | ( | — | ( | |||||||||||||||||||||||||||||||
Unrealized gain from available-for-sale securities | — | — | — | ( | — | ( | |||||||||||||||||||||||||||||
Vesting of restricted shares | — | — | — | — | — | ||||||||||||||||||||||||||||||
Exercise of options | — | — | — | ||||||||||||||||||||||||||||||||
Issuance of common stock upon purchase by employee stock purchase plan | — | — | — | ||||||||||||||||||||||||||||||||
Share-based compensation expense | — | — | — | — | |||||||||||||||||||||||||||||||
Balance at March 31, 2021 | $ | $ | $ | $ | ( | $ | ( | ||||||||||||||||||||||||||||
Net loss | — | — | — | — | ( | ( | |||||||||||||||||||||||||||||
Vesting of restricted shares | — | — | — | — | — | ||||||||||||||||||||||||||||||
Exercise of options | — | — | — | ||||||||||||||||||||||||||||||||
Share-based compensation expense | — | — | — | ||||||||||||||||||||||||||||||||
Balance at June 30, 2021 | $ | $ | $ | $ | $ | ( | $ | ( |
Six Months Ended June 30, | |||||||||||
2022 | 2021 | ||||||||||
CASH FLOWS USED IN OPERATING ACTIVITIES: | |||||||||||
Net loss | $ | ( | $ | ( | |||||||
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||||||
Depreciation and amortization | |||||||||||
Amortization of premium/discount on marketable securities, net | |||||||||||
Amortization of debt discount and debt issuance costs | |||||||||||
Share-based compensation | |||||||||||
Gain on extinguishment of debt | ( | ||||||||||
Gain on the lease termination | ( | ||||||||||
Changes in operating assets and liabilities: | |||||||||||
Inventory | ( | ( | |||||||||
Accounts receivable, net | ( | ( | |||||||||
Prepaid expenses | ( | ||||||||||
License receivables | ( | ||||||||||
Other current assets | ( | ||||||||||
Operating lease right of use assets | |||||||||||
Other long-term assets | ( | ||||||||||
Accounts payable | ( | ||||||||||
Deferred revenue | ( | ||||||||||
Accrued expenses and other current liabilities | ( | ||||||||||
Lease liability, operating leases | ( | ( | |||||||||
Net cash used in operating activities | ( | ( | |||||||||
CASH FLOWS PROVIDED BY INVESTING ACTIVITIES: | |||||||||||
Purchases of property and equipment | ( | ||||||||||
Sales and maturities of marketable securities | |||||||||||
Net cash (used in) provided by investing activities | ( | ||||||||||
CASH FLOWS PROVIDED BY FINANCING ACTIVITIES: | |||||||||||
Proceeds from exercise of stock options | |||||||||||
Proceeds from issuance of term loan, net of issuance costs | |||||||||||
Repurchase of convertible notes | ( | ||||||||||
Proceeds from issuance of shares under employee stock purchase plan | |||||||||||
Net cash provided by financing activities | |||||||||||
NET (DECREASE) INCREASE IN CASH, CASH EQUIVALENTS, AND RESTRICTED CASH | ( | ||||||||||
CASH, CASH EQUIVALENTS, AND RESTRICTED CASH AT BEGINNING OF PERIOD | |||||||||||
CASH, CASH EQUIVALENTS, AND RESTRICTED CASH AT END OF PERIOD | $ | $ | |||||||||
SUPPLEMENTAL DISCLOSURES: | |||||||||||
Cash paid for interest | $ | $ | |||||||||
Cash paid for amounts included in the measurement of operating lease liabilities | $ | $ | |||||||||
Right of use assets obtained in exchange for operating lease liability | $ | $ |
As of June 30, 2022 | |||||||||||||||||||||||
Level 1 | Level 2 | Level 3 | Total | ||||||||||||||||||||
Assets | |||||||||||||||||||||||
Cash and cash equivalents: | |||||||||||||||||||||||
Cash | $ | $ | $ | $ | |||||||||||||||||||
Money market funds (1) | |||||||||||||||||||||||
Total | $ | $ | $ | $ | |||||||||||||||||||
As of December 31, 2021 | |||||||||||||||||||||||
Level 1 | Level 2 | Level 3 | Total | ||||||||||||||||||||
Assets | |||||||||||||||||||||||
Cash and cash equivalents: | |||||||||||||||||||||||
Cash | $ | $ | $ | $ | |||||||||||||||||||
Money market funds (1) | |||||||||||||||||||||||
Total | $ | $ | $ | $ | |||||||||||||||||||
June 30, 2022 | December 31, 2021 | |||||||||||||
Raw materials | $ | $ | ||||||||||||
Work in process | ||||||||||||||
Finished goods | ||||||||||||||
Total inventories | $ | $ |
2024 Convertible Notes | |||||
Liability | |||||
Principal | $ | ||||
Less: debt discount and issuance costs | ( | ||||
Net carrying amount | $ |
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||||||||||
Contractual interest expense | |||||||||||||||||||||||
Amortization of debt discount | |||||||||||||||||||||||
Amortization of debt issuance costs | |||||||||||||||||||||||
Total interest expense | $ | $ | $ | $ |
Years ended December 31, | Future Minimum Payments | ||||
2022 (excluding the 6 months ended June 30, 2022) | |||||
2023 | |||||
2024 | |||||
Total minimum payments | $ | ||||
Less: interest | ( | ||||
Less: unamortized discount | ( | ||||
Convertible notes payable | $ |
Term loan | |||||
Principal | $ | ||||
Less: debt issuance costs | ( | ||||
Net carrying amount | $ |
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||||||||||
Contractual interest expense | $ | $ | $ | $ | |||||||||||||||||||
Amortization of debt discount | |||||||||||||||||||||||
Total interest expense | $ | $ | $ | $ |
Years ended December 31, | Future Minimum Payments | ||||
2022 (excluding the 6 months ended June 30, 2022) | |||||
2023 | |||||
2024 | |||||
Total minimum payments | $ | ||||
Less: interest | ( | ||||
Less: unamortized issuance costs | ( | ||||
Term loan | $ | ||||
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||||||||||
Numerator: | |||||||||||||||||||||||
Net loss | $ | ( | $ | ( | $ | ( | $ | ( | |||||||||||||||
Denominator: | |||||||||||||||||||||||
Weighted-average number of common shares used in loss per share - basic and diluted | |||||||||||||||||||||||
Loss per share - basic and diluted | $ | ( | $ | ( | $ | ( | $ | ( |
Three and Six Months Ended June 30, | ||||||||||||||
2022 | 2021 | |||||||||||||
Options to purchase common stock | ||||||||||||||
Restricted stock units | ||||||||||||||
Performance units | ||||||||||||||
Performance options |
Chargebacks, Discounts, and Fees | Government and other rebates | Returns | Total | ||||||||||||||||||||
Ending balance at December 31, 2021 | $ | $ | $ | $ | |||||||||||||||||||
Provision related to sales in the current year | |||||||||||||||||||||||
Adjustments related to prior period sales | ( | ( | |||||||||||||||||||||
Credits and payments made | ( | ( | ( | ( | |||||||||||||||||||
Ending balance at June 30, 2022 | $ | $ | $ | $ | |||||||||||||||||||
Ending balance at December 31, 2020 | $ | $ | $ | $ | |||||||||||||||||||
Provision related to sales in the current year | |||||||||||||||||||||||
Adjustments related to prior period sales | ( | ( | ( | ( | |||||||||||||||||||
Credits and payments made | ( | ( | ( | ( | |||||||||||||||||||
Ending balance at June 30, 2021 | $ | $ | $ | $ | |||||||||||||||||||
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||||||||||
Program-specific costs - external: | |||||||||||||||||||||||
Abaloparatide-SC | $ | 913 | $ | 3,116 | $ | 3,026 | $ | 10,725 | |||||||||||||||
Abaloparatide-TD | 5,775 | 9,946 | 8,932 | 20,393 | |||||||||||||||||||
Elacestrant (RAD1901) | 1,756 | 212 | (762) | 1,622 | |||||||||||||||||||
RAD140 | — | 216 | 1 | 309 | |||||||||||||||||||
RAD011 | 5,197 | 3,612 | 10,969 | 3,621 | |||||||||||||||||||
Total program-specific costs - external | $ | 13,641 | $ | 17,102 | $ | 22,166 | $ | 36,670 | |||||||||||||||
Shared-services costs - external: | |||||||||||||||||||||||
R&D support costs | 4,751 | 3,041 | 9,358 | 8,167 | |||||||||||||||||||
Other operating costs | 90 | 163 | 928 | 369 | |||||||||||||||||||
Total shared-services costs - external | $ | 4,841 | $ | 3,204 | $ | 10,286 | $ | 8,536 | |||||||||||||||
Shared-services costs - internal | |||||||||||||||||||||||
Personnel-related costs | 6,087 | 4,997 | 13,163 | 9,887 | |||||||||||||||||||
Share-based compensation | 1,433 | 1,607 | 2,675 | 3,208 | |||||||||||||||||||
Occupancy costs | 268 | 9 | 636 | 18 | |||||||||||||||||||
Depreciation expense | 42 | 31 | 83 | 72 | |||||||||||||||||||
Total shared-services costs - internal | $ | 7,830 | $ | 6,644 | $ | 16,557 | $ | 13,185 | |||||||||||||||
Total research and development costs | $ | 26,312 | $ | 26,950 | $ | 49,009 | $ | 58,391 |
Three Months Ended | |||||||||||||||||||||||
June 30, | Change | ||||||||||||||||||||||
2022 | 2021 | $ | % | ||||||||||||||||||||
Revenues: | |||||||||||||||||||||||
Product revenue, net | $ | 52,535 | $ | 51,797 | $ | 738 | 1 | % | |||||||||||||||
License revenue | 5,750 | — | 5,750 | 100 | % | ||||||||||||||||||
Total revenue | 58,285 | 51,797 | 6,488 | 13 | % | ||||||||||||||||||
Operating expenses: | |||||||||||||||||||||||
Cost of sales - product | 5,377 | 4,394 | 983 | 22 | % | ||||||||||||||||||
Cost of sales - intangible amortization | 199 | 200 | (1) | (1) | % | ||||||||||||||||||
Research and development, net of amounts reimbursable | 26,312 | 26,950 | (638) | (2) | % | ||||||||||||||||||
Selling, general and administrative | 34,248 | 32,143 | 2,105 | 7 | % | ||||||||||||||||||
Loss from operations | (7,851) | (11,890) | 4,039 | 34 | % | ||||||||||||||||||
Other (expense) income: | |||||||||||||||||||||||
Other expense, net | (109) | (79) | (30) | (38) | % | ||||||||||||||||||
Interest expense | (4,861) | (4,847) | (14) | — | % | ||||||||||||||||||
Interest income | 88 | 6 | 82 | 1367 | % | ||||||||||||||||||
Net loss | $ | (12,733) | $ | (16,810) | $ | 4,077 | 24 | % |
Six Months Ended | |||||||||||||||||||||||
June 30, | Change | ||||||||||||||||||||||
2022 | 2021 | $ | % | ||||||||||||||||||||
Revenues: | |||||||||||||||||||||||
Product revenue, net | $ | 95,493 | $ | 97,057 | $ | (1,564) | (2) | % | |||||||||||||||
License revenue | 5,950 | 11,000 | (5,050) | (46) | % | ||||||||||||||||||
Total revenue | 101,443 | 108,057 | (6,614) | (6) | % | ||||||||||||||||||
Operating expenses: | |||||||||||||||||||||||
Cost of sales - product | 9,437 | 8,319 | 1,118 | 13 | % | ||||||||||||||||||
Cost of sales - intangible amortization | 399 | 399 | — | — | % | ||||||||||||||||||
Research and development, net of amounts reimbursable | 49,009 | 58,391 | (9,382) | (16) | % | ||||||||||||||||||
Selling, general and administrative | 64,296 | 66,240 | (1,944) | (3) | % | ||||||||||||||||||
Loss from operations | (21,698) | (25,292) | 3,594 | 14 | % | ||||||||||||||||||
Other (expense) income: | |||||||||||||||||||||||
Other income (expense), net | 269 | (80) | 349 | (436) | % | ||||||||||||||||||
Interest expense | (9,683) | (9,211) | (472) | (5) | % | ||||||||||||||||||
Interest income | 102 | 64 | 38 | 59 | % | ||||||||||||||||||
Gain on extinguishment of debt | — | 1,960 | (1,960) | (100) | % | ||||||||||||||||||
Net loss | $ | (31,010) | $ | (32,559) | 1,549 | 5 | % |
Six Months Ended | |||||||||||||||||||||||
June 30, | Change | ||||||||||||||||||||||
2022 | 2021 | $ | % | ||||||||||||||||||||
Net cash (used in) provided by: | |||||||||||||||||||||||
Operating activities | $ | (39,175) | $ | (34,104) | $ | (5,071) | (15) | % | |||||||||||||||
Investing activities | (349) | 23,240 | (23,589) | (102) | % | ||||||||||||||||||
Financing activities | 482 | 18,601 | (18,119) | (97) | % | ||||||||||||||||||
Net increase in cash, cash equivalents, and restricted cash | $ | (39,042) | $ | 7,737 | $ | (46,779) | (605) | % |
Incorporated by Reference | Filed/ | |||||||||||||||||||||||||||||||||||||
Exhibit | Filing | Furnished | ||||||||||||||||||||||||||||||||||||
Number | Exhibit Description | Form | File No. | Exhibit | Date | Herewith | ||||||||||||||||||||||||||||||||
Agreement and Plan of Merger, dated as of June 23, 2022, by and among the Company, Ginger Acquisition, Inc. and Ginger Merger Sub, Inc. | 8-K | 001-35726 | 2.1 | 6/23/2022 | ||||||||||||||||||||||||||||||||||
Restated Certificate of Incorporation | 8-K | 001-35726 | 3.1 | 6/13/2014 | ||||||||||||||||||||||||||||||||||
Amended and Restated By-Laws | 8-K | 001-35726 | 3.2 | 9/27/2021 | ||||||||||||||||||||||||||||||||||
Certification of Chief Executive Officer pursuant to Exchange Act Rule 13a-14(a)/15d-14(a) | * | |||||||||||||||||||||||||||||||||||||
Certification of Principal Financial Officer pursuant to Exchange Act Rule 13a-14(a)/15d-14(a) | * | |||||||||||||||||||||||||||||||||||||
Certification of Chief Executive Officer and Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | ** | |||||||||||||||||||||||||||||||||||||
101.SCH | Inline XBRL Taxonomy Extension Schema Document | * | ||||||||||||||||||||||||||||||||||||
101.CAL | Inline XBRL Taxonomy Extension Calculation Linkbase Document | * | ||||||||||||||||||||||||||||||||||||
101.LAB | Inline XBRL Taxonomy Extension Label Linkbase Document | * | ||||||||||||||||||||||||||||||||||||
101.PRE | Inline XBRL Taxonomy Extension Presentation Linkbase Document | * | ||||||||||||||||||||||||||||||||||||
101.DEF | Inline XBRL Taxonomy Extension Definition Linkbase Document | * | ||||||||||||||||||||||||||||||||||||
104 | Cover Page Interactive Data File (formatted as inline XBRL with applicable taxonomy extension information contained in Exhibits 101.*) | * |
RADIUS HEALTH, INC. | ||||||||
By: | /s/ G. Kelly Martin | |||||||
G. Kelly Martin | ||||||||
President and Chief Executive Officer | ||||||||
(Principal Executive Officer) | ||||||||
Date: August 9, 2022 | ||||||||
By: | /s/ Mark W. Conley | |||||||
Mark W. Conley | ||||||||
Vice President and Chief Financial Officer | ||||||||
(Principal Accounting and Financial Officer) | ||||||||
Date: August 9, 2022 |
/s/ G. Kelly Martin | |||||
G. Kelly Martin | |||||
President and Chief Executive Officer |
/s/ Mark W. Conley | |||||
Mark W. Conley | |||||
Vice President and Chief Financial Officer |
Date: | August 9, 2022 | |||||||||||||
By: | /s/ G. Kelly Martin | |||||||||||||
G. Kelly Martin | ||||||||||||||
President and Chief Executive Officer | ||||||||||||||
Date: | August 9, 2022 | |||||||||||||
By: | /s/ Mark W. Conley | |||||||||||||
Mark W. Conley | ||||||||||||||
Vice President and Chief Financial Officer |
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares |
Jun. 30, 2022 |
Dec. 31, 2021 |
---|---|---|
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) | 47,607,604 | 47,359,573 |
Common stock, shares outstanding (in shares) | 47,607,604 | 47,359,573 |
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands |
3 Months Ended | 6 Months Ended | ||||
---|---|---|---|---|---|---|
Jun. 30, 2022 |
Jun. 30, 2021 |
Jun. 30, 2022 |
Jun. 30, 2021 |
|||
REVENUES: | ||||||
Total revenue | $ 58,285 | $ 51,797 | $ 101,443 | $ 108,057 | ||
OPERATING EXPENSES: | ||||||
Cost of sales - product | 5,377 | 4,394 | 9,437 | 8,319 | ||
Cost of sales - intangible amortization | 199 | 200 | 399 | 399 | ||
Research and development, net of amounts reimbursable | [1] | 26,312 | 26,950 | 49,009 | 58,391 | |
Selling, general and administrative | 34,248 | 32,143 | 64,296 | 66,240 | ||
Loss from operations | (7,851) | (11,890) | (21,698) | (25,292) | ||
OTHER INCOME (EXPENSE): | ||||||
Other (expense) income | (109) | (79) | 269 | (80) | ||
Interest expense | (4,861) | (4,847) | (9,683) | (9,211) | ||
Interest income | 88 | 6 | 102 | 64 | ||
Gain on extinguishment of debt | 0 | 0 | 0 | 1,960 | ||
NET LOSS | (12,733) | (16,810) | (31,010) | (32,559) | ||
OTHER COMPREHENSIVE LOSS: | ||||||
Foreign currency | 44 | 0 | 50 | 0 | ||
Unrealized loss from available-for-sale debt securities | 0 | 0 | 0 | (21) | ||
COMPREHENSIVE LOSS | (12,689) | (16,810) | (30,960) | (32,580) | ||
LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS - BASIC | (12,733) | (16,810) | (31,010) | (32,559) | ||
LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS - DILUTED | $ (12,733) | $ (16,810) | $ (31,010) | $ (32,559) | ||
LOSS PER SHARE: | ||||||
Basic (in dollars per share) | $ (0.27) | $ (0.35) | $ (0.65) | $ (0.69) | ||
Diluted (in dollars per share) | $ (0.27) | $ (0.35) | $ (0.65) | $ (0.69) | ||
WEIGHTED AVERAGE SHARES: | ||||||
Basic (in shares) | 47,588,158 | 47,391,530 | 47,515,394 | 47,114,947 | ||
Diluted (in shares) | 47,588,158 | 47,391,530 | 47,515,394 | 47,114,947 | ||
Product revenue, net | ||||||
REVENUES: | ||||||
Total revenue | $ 52,535 | $ 51,797 | $ 95,493 | $ 97,057 | ||
License revenue | ||||||
REVENUES: | ||||||
Total revenue | $ 5,750 | $ 0 | $ 5,950 | $ 11,000 | ||
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Condensed Consolidated Statements of Operations and Comprehensive Loss (Parenthetical) - USD ($) $ in Millions |
3 Months Ended | 6 Months Ended | ||
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Jun. 30, 2022 |
Jun. 30, 2021 |
Jun. 30, 2022 |
Jun. 30, 2021 |
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Income Statement [Abstract] | ||||
Reimbursable expenses | $ 9.6 | $ 18.5 | $ 18.7 | $ 32.8 |
Organization |
6 Months Ended |
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Jun. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization | Organization Radius Health, Inc. (“Radius,” the “Company,” “us,” “our” or “we”) is a global biopharmaceutical company focused on addressing unmet medical needs in the areas of bone health, neuroscience, 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. We are also developing certain assets we acquired related to formulations of cannabidiol related to the oral administration of a solution of CBD for therapeutic use in humans or animals (“RAD011”), for which the Company intends to seek FDA approval for a Phase 2/3 trial for treatment of hyperphagia behavior and weight loss in patients with Prader Willi syndrome (“PWS”). In June 2022, with support from the Company, our licensee, Berlin-Chemie AG, a company of the Menarini Group (“Berlin-Chemie”), submitted a New Drug Application (“NDA”) to the FDA for elacestrant in patients with ER+/HER2- advanced or metastatic breast cancer. The NDA submission was based on positive top-line results from the EMERALD Phase 3 study of our investigational product candidate elacestrant that was previously announced in October 2021. Berlin-Chemie holds an exclusive, worldwide license to develop and commercialize products containing elacestrant. The Company is subject to risks common to companies in its industry including, but not limited to, the dependence on revenues from a single commercialized product, competition, uncertainty about clinical trial outcomes and regulatory approvals, uncertainties relating to pharmaceutical pricing reimbursement, uncertain protection of proprietary technology and potential product liability. As of June 30, 2022, the Company had an accumulated deficit of $1,399.0 million, and total cash and cash equivalents of $72.5 million. Based upon its cash and cash equivalents balance and the $25.0 million secured revolving credit facility available to the Company under its Revolving Credit Agreement with MidCap Funding IV Trust as discussed in Note 6, “Term Loan and Credit Facilities” as of June 30, 2022, the Company believes that, prior to the consideration of revenue from the potential future sales of any of its investigational products that may receive regulatory approval or proceeds from partnering and/or collaboration activities, it has sufficient capital to fund its commercial operations, development plans, and other operational activities for at least one year from the date of this filing. The Company expects to finance its ongoing and future operations with its product revenue, existing cash and cash equivalents, or through strategic financing opportunities that could include, but are not limited to collaboration agreements or the incurrence of debt. However, there is no guarantee that any strategic or financing opportunities will be executed or executed on favorable terms, and some could be dilutive to existing stockholders. Pending Transaction On June 23, 2022, the Company entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Ginger Acquisition, Inc., (“Parent”), a subsidiary jointly owned by affiliates of Gurnet Point Capital, LLC and Patient Square Capital, LP, and Ginger Merger Sub, Inc., a wholly owned subsidiary of Parent (“Purchaser”). Pursuant to the Merger Agreement, and upon the terms and subject to the conditions thereof, Purchaser has commenced a tender offer (the “Offer”) to purchase each issued and outstanding share (the “Shares”) of common stock of the Company (the “Common Stock”) in exchange for an amount in cash equal to $10.00 and one contractual contingent value right (a “CVR”) that will represent the right to receive a contingent payment of $1.00 in cash, without interest but subject to applicable withholding upon the achievement of the sum of (A) cumulative net sales of TYMLOS in the United States and (B) either (i) royalty payments based on sales of TYMLOS in Japan or (ii) if and at such time that no such royalty payments are owed, supply payments based on the supply of TYMLOS for sale in Japan that together exceed $300 million during any consecutive 12-month period beginning on the date of the CVR Agreement (defined below) and ending on or prior to December 31, 2025, pursuant to a Contingent Value Rights Agreement (the “CVR Agreement”) to be entered into between Parent and a rights agent. The Offer is currently scheduled to expire at one minute after 11:59 p.m. Eastern Time on August 10, 2022, the twentieth business day following the commencement of the Offer, but may be extended in accordance with the terms of the Merger Agreement. Subject to the terms and conditions of the Merger Agreement, if certain conditions are satisfied and the Offer closes, Parent, no later than the second day following the satisfaction of such conditions, would acquire any remaining shares by virtue of a merger of Purchaser with and into the Company (the “Merger”), with the Company being the surviving corporation and a wholly-owned subsidiary of Parent. If the Merger is consummated, the Company will cease to be a publicly-traded company. The consummation of the transaction is subject to customary closing conditions, including the Company’s stockholders tendering a minimum number of Shares in the Offer and receipt of regulatory approvals.
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Basis of Presentation and Significant Accounting Policies |
6 Months Ended |
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Jun. 30, 2022 | |
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, revenue, expenses and related disclosures at the date of the financial statements. Actual results could differ from those estimates. Additionally, operating results for the three and six months ended June 30, 2022 are not necessarily indicative of the results that may be expected for any other interim period or for the fiscal year ending December 31, 2022. 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, 2021, filed with the Securities and Exchange Commission (“SEC”) on February 24, 2022. Significant Accounting Policies The significant accounting policies identified in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 that require the Company to make estimates and assumptions include: revenue recognition, inventory obsolescence, long-lived assets and intangible assets, accounting for share-based compensation, contingencies, tax valuation reserves, fair value measures, and accrued expenses. There were no changes to significant accounting policies during the six months ended June 30, 2022. Recent Accounting Standards Not Yet Adopted There are no applicable material accounting pronouncements recently issued that have not yet been adopted by the Company.
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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: •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. 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 six months ended June 30, 2022 or 2021. The following table summarizes the financial instruments measured at fair value on a recurring basis as of June 30, 2022 and December 31, 2021 (in thousands):
(1) Fair value is based upon quoted market prices. The Company considers only those investments that are highly liquid, readily convertible to cash, and that mature within three months from the date of purchase to be cash equivalents. From time to time, the Company may have balances in financial institutions in excess of insurance limits. The Company has not experienced any losses related to these balances. The Company’s Convertible Notes are classified within Level 2 in the fair value hierarchy. 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. 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 June 30, 2022 was approximately $189.1 million. The Company’s Term Loan falls into the Level 2 category within the fair value level hierarchy and the fair value was determined using quoted prices for similar liabilities in active markets, as well as inputs that are observable for the liability (other than quoted prices), such as interest rates that are observable at commonly quoted intervals. The estimated fair value of the Term Facility as of June 30, 2022 was approximately $147.2 million. As of June 30, 2022, the carrying amounts of the cash and cash equivalents, restricted cash, accounts receivable, prepaid expenses, license receivables, other current assets, accounts payable, accrued expenses, and operating lease liabilities approximated their estimated fair values.
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Inventory |
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Inventory Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Inventory | Inventory Inventory consisted of the following as of June 30, 2022 and December 31, 2021 (in thousands):
Finished goods manufactured by the Company have a 36-month shelf life from date of manufacture.
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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 $300.0 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 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. 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. 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. The Convertible Notes may be redeemed at the Company’s option, in whole or in part, if the conditions described below are satisfied. The redemption of the Convertible Notes may also be subject to certain restrictions in the Credit Agreements. 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: (1)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. As of June 30, 2022, none of the above circumstances had occurred and, as such, the Convertible Notes were not convertible. The Company expects that a fundamental change, a make-whole fundamental change and a share exchange event will occur upon the consummation of the Offer and the Merger. Upon a fundamental change, holders of Convertible Notes are permitted to require the Company to repurchase for cash all or any portion of their Convertible Notes at a fundamental change repurchase price equal to 100% of the principal amount of the Convertible Notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date. Upon a make-whole fundamental change, under certain circumstances, the conversion rate for notes converted in connection with such make-whole fundamental change will increase. However, if the price per share of our common stock paid (or deemed paid) in the transaction is less than $36.835 per share, the conversion rate will not be increased. As a result, the Company does not expect the make-whole fundamental change will trigger an adjustment to the conversion rate. On or after the occurrence of a share exchange event, the right to convert the Convertible Notes will be substituted with the right to receive an amount in cash equal to the per share amount of cash received by holders of the Company’s common stock 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. In March 2021, the Company entered into separate, privately negotiated transactions with certain holders of the Convertible Notes to repurchase $112.2 million face amount of the Convertible Notes for a cash purchase of $108.6 million. As the Company only extinguished a portion of the debt, the difference between the reacquisition price and the net carrying amount of the extinguished portion resulted in a gain on extinguishment of $2.0 million. Third party costs associated with the extinguishment of $0.3 million were included in selling, general and administrative expense for the six months ended June 30, 2021. The outstanding balances of the Convertible Notes as of June 30, 2022 consisted of the following (in thousands):
The debt issuance costs on the Convertible Notes will be amortized over the remaining period. The Company determined the expected life of the Convertible Notes was equal to their seven-year term. The effective interest rate on the Convertible Notes is 3.43%. As of June 30, 2022, the “if-converted value” did not exceed the remaining principal amount of the Convertible Notes. The following table sets forth total interest expense recognized related to the Convertible Notes during the three months and six ended June 30, 2022 and 2021 (in thousands):
Future minimum payments on the Company’s Convertible Notes as of June 30, 2022 are as follows (in thousands):
On March 3, 2021, the Company and two of its wholly-owned subsidiaries, Radius Pharmaceuticals, Inc. and Radius Health Ventures, Inc. (collectively with the Company, the “Borrowers”), entered into an (i) Amended and Restated Credit and Security Agreement (Term Loan) (the “Term Credit Agreement”), with MidCap Funding IV Trust, in its capacity as administrative agent, and the financial institutions or other entities from time to time parties thereto as lenders (the “Term Lenders”) and (ii) Amended and Restated Credit and Security Agreement (Revolving Loan) (the “Revolving Credit Agreement,” together with the Term Credit Agreement, the “Credit Agreements”), with MidCap Funding IV Trust, in its capacity as administrative agent, and the financial institutions or other entities from time to time parties thereto as lenders. The Term Credit Agreement provides for a secured term loan facility (the “Term Facility”) in an aggregate principal amount of $150.0 million (the “Initial Term Loan”), an increase of $125.0 million from the arrangement entered into in January 2020. The Revolving Credit Agreement provides for a secured revolving credit facility (the “Revolving Facility”, together with the Term Facility, the “Facilities”) under which the Borrowers may borrow up to $25.0 million, the availability of which is determined based on a borrowing base as follows: (i) up to 85% of the net collectable value of the Borrowers’ domestic accounts receivable due from eligible direct and third-party payors, plus (ii) up to 40% of the Borrowers’ domestic eligible inventory, minus certain reserves; provided that the availability from eligible inventory may not exceed 20% of the borrowing base at any time. As of June 30, 2022 and up to the date of issuance of these condensed consolidated financial statements, the Company was eligible to borrow $25.0 million of the Revolving Facility. The Facilities have a maturity date of June 1, 2024. The obligations under the Credit Agreements are guaranteed by the Borrowers and are guaranteed by certain future subsidiaries of the Borrowers, subject to certain exceptions. The obligations under the Facilities are secured by substantially all of the assets of the Borrowers, and are secured by substantially all assets of the future subsidiaries of the Borrowers that become borrowers or guarantors under the Facilities, subject to certain exceptions. Borrowings under the Term Facility bear interest through maturity at a variable rate based upon the LIBOR rate plus 5.75%, subject to a LIBOR floor of 2.00%. Borrowings under the Revolving Facility bear interest through maturity at a variable rate based upon the LIBOR rate plus 3.50%, subject to a LIBOR floor of 2.00%. The Borrowers are required to pay a monthly commitment fee on the unused commitments under the Revolving Facility of 0.50% per annum. The Company’s obligations under the Credit Agreement are secured by substantially all of the assets of the Borrowers and their wholly-owned subsidiaries. The security interest granted over these assets could limit the Company’s ability to obtain additional debt financing. In addition, the Credit Agreements contain affirmative and negative covenants customarily applicable to senior secured credit facilities, including covenants that, among other things, will limit or restrict the Company’s ability, subject to negotiated exceptions, to incur additional indebtedness and additional liens on its assets, engage in mergers or acquisitions or dispose of assets, pay dividends or make other distributions, voluntarily prepay other indebtedness, enter into transactions with affiliated persons, make investments, and change the nature of its businesses. In addition, the Company is required to maintain an amount of unrestricted cash of at least $50.0 million and to achieve net revenue for each preceding twelve-month period of at least certain specified amounts. Failure to comply with the covenants in the Credit Agreements, including the minimum cash and minimum net revenue covenants, could result in the acceleration of its obligations under the Credit Agreements. The Company expects the Credit Agreements to be repaid in full and terminated in connection with the consummation of the Offer and the Merger. On March 11, 2021, the Company received proceeds of $122.6 million under the Term Loan, net of fees and expenses of $2.4 million. With the issuance of a new term loan, the Company performed an assessment comparing the discounted cash flows of the original debt and the new debt as of the modification date, and concluded that the change is considered a modification. As of the modification date, the Company established a new effective interest rate based on the carrying value of the debt and the revised cash flows. Fees paid to the lender of $2.4 million were capitalized as debt discount and will be amortized to interest expense using the effective interest method over the term of the loan. Third party costs associated with the modification of $2.8 million were included in selling, general and administrative expense for the six months ended June 30, 2021. The outstanding balance of the Term Loan as of June 30, 2022 consisted of the following (in thousands):
The following table sets forth total interest expense recognized related to the Term Facility during the three and six months ended June 30, 2022 and 2021 (in thousands):
Future minimum payments on the Term Facility as of June 30, 2022 are as follows (in thousands):
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Term Loan and Credit Facilities |
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Debt Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Term Loan and Credit Facilities | Convertible Notes Payable On August 14, 2017, in a registered underwritten public offering, the Company issued $300.0 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 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. 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. 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. The Convertible Notes may be redeemed at the Company’s option, in whole or in part, if the conditions described below are satisfied. The redemption of the Convertible Notes may also be subject to certain restrictions in the Credit Agreements. 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: (1)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. As of June 30, 2022, none of the above circumstances had occurred and, as such, the Convertible Notes were not convertible. The Company expects that a fundamental change, a make-whole fundamental change and a share exchange event will occur upon the consummation of the Offer and the Merger. Upon a fundamental change, holders of Convertible Notes are permitted to require the Company to repurchase for cash all or any portion of their Convertible Notes at a fundamental change repurchase price equal to 100% of the principal amount of the Convertible Notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date. Upon a make-whole fundamental change, under certain circumstances, the conversion rate for notes converted in connection with such make-whole fundamental change will increase. However, if the price per share of our common stock paid (or deemed paid) in the transaction is less than $36.835 per share, the conversion rate will not be increased. As a result, the Company does not expect the make-whole fundamental change will trigger an adjustment to the conversion rate. On or after the occurrence of a share exchange event, the right to convert the Convertible Notes will be substituted with the right to receive an amount in cash equal to the per share amount of cash received by holders of the Company’s common stock 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. In March 2021, the Company entered into separate, privately negotiated transactions with certain holders of the Convertible Notes to repurchase $112.2 million face amount of the Convertible Notes for a cash purchase of $108.6 million. As the Company only extinguished a portion of the debt, the difference between the reacquisition price and the net carrying amount of the extinguished portion resulted in a gain on extinguishment of $2.0 million. Third party costs associated with the extinguishment of $0.3 million were included in selling, general and administrative expense for the six months ended June 30, 2021. The outstanding balances of the Convertible Notes as of June 30, 2022 consisted of the following (in thousands):
The debt issuance costs on the Convertible Notes will be amortized over the remaining period. The Company determined the expected life of the Convertible Notes was equal to their seven-year term. The effective interest rate on the Convertible Notes is 3.43%. As of June 30, 2022, the “if-converted value” did not exceed the remaining principal amount of the Convertible Notes. The following table sets forth total interest expense recognized related to the Convertible Notes during the three months and six ended June 30, 2022 and 2021 (in thousands):
Future minimum payments on the Company’s Convertible Notes as of June 30, 2022 are as follows (in thousands):
On March 3, 2021, the Company and two of its wholly-owned subsidiaries, Radius Pharmaceuticals, Inc. and Radius Health Ventures, Inc. (collectively with the Company, the “Borrowers”), entered into an (i) Amended and Restated Credit and Security Agreement (Term Loan) (the “Term Credit Agreement”), with MidCap Funding IV Trust, in its capacity as administrative agent, and the financial institutions or other entities from time to time parties thereto as lenders (the “Term Lenders”) and (ii) Amended and Restated Credit and Security Agreement (Revolving Loan) (the “Revolving Credit Agreement,” together with the Term Credit Agreement, the “Credit Agreements”), with MidCap Funding IV Trust, in its capacity as administrative agent, and the financial institutions or other entities from time to time parties thereto as lenders. The Term Credit Agreement provides for a secured term loan facility (the “Term Facility”) in an aggregate principal amount of $150.0 million (the “Initial Term Loan”), an increase of $125.0 million from the arrangement entered into in January 2020. The Revolving Credit Agreement provides for a secured revolving credit facility (the “Revolving Facility”, together with the Term Facility, the “Facilities”) under which the Borrowers may borrow up to $25.0 million, the availability of which is determined based on a borrowing base as follows: (i) up to 85% of the net collectable value of the Borrowers’ domestic accounts receivable due from eligible direct and third-party payors, plus (ii) up to 40% of the Borrowers’ domestic eligible inventory, minus certain reserves; provided that the availability from eligible inventory may not exceed 20% of the borrowing base at any time. As of June 30, 2022 and up to the date of issuance of these condensed consolidated financial statements, the Company was eligible to borrow $25.0 million of the Revolving Facility. The Facilities have a maturity date of June 1, 2024. The obligations under the Credit Agreements are guaranteed by the Borrowers and are guaranteed by certain future subsidiaries of the Borrowers, subject to certain exceptions. The obligations under the Facilities are secured by substantially all of the assets of the Borrowers, and are secured by substantially all assets of the future subsidiaries of the Borrowers that become borrowers or guarantors under the Facilities, subject to certain exceptions. Borrowings under the Term Facility bear interest through maturity at a variable rate based upon the LIBOR rate plus 5.75%, subject to a LIBOR floor of 2.00%. Borrowings under the Revolving Facility bear interest through maturity at a variable rate based upon the LIBOR rate plus 3.50%, subject to a LIBOR floor of 2.00%. The Borrowers are required to pay a monthly commitment fee on the unused commitments under the Revolving Facility of 0.50% per annum. The Company’s obligations under the Credit Agreement are secured by substantially all of the assets of the Borrowers and their wholly-owned subsidiaries. The security interest granted over these assets could limit the Company’s ability to obtain additional debt financing. In addition, the Credit Agreements contain affirmative and negative covenants customarily applicable to senior secured credit facilities, including covenants that, among other things, will limit or restrict the Company’s ability, subject to negotiated exceptions, to incur additional indebtedness and additional liens on its assets, engage in mergers or acquisitions or dispose of assets, pay dividends or make other distributions, voluntarily prepay other indebtedness, enter into transactions with affiliated persons, make investments, and change the nature of its businesses. In addition, the Company is required to maintain an amount of unrestricted cash of at least $50.0 million and to achieve net revenue for each preceding twelve-month period of at least certain specified amounts. Failure to comply with the covenants in the Credit Agreements, including the minimum cash and minimum net revenue covenants, could result in the acceleration of its obligations under the Credit Agreements. The Company expects the Credit Agreements to be repaid in full and terminated in connection with the consummation of the Offer and the Merger. On March 11, 2021, the Company received proceeds of $122.6 million under the Term Loan, net of fees and expenses of $2.4 million. With the issuance of a new term loan, the Company performed an assessment comparing the discounted cash flows of the original debt and the new debt as of the modification date, and concluded that the change is considered a modification. As of the modification date, the Company established a new effective interest rate based on the carrying value of the debt and the revised cash flows. Fees paid to the lender of $2.4 million were capitalized as debt discount and will be amortized to interest expense using the effective interest method over the term of the loan. Third party costs associated with the modification of $2.8 million were included in selling, general and administrative expense for the six months ended June 30, 2021. The outstanding balance of the Term Loan as of June 30, 2022 consisted of the following (in thousands):
The following table sets forth total interest expense recognized related to the Term Facility during the three and six months ended June 30, 2022 and 2021 (in thousands):
Future minimum payments on the Term Facility as of June 30, 2022 are as follows (in thousands):
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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 six months ended June 30, 2022 and 2021, respectively, all of the Company’s options to purchase common stock, restricted stock units outstanding, and performance options 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 June 30, 2022, 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 six month periods ended June 30, 2022 and 2021, respectively. The Company uses the if-converted method for the Convertible Notes.
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Product Revenue Reserves and Allowances |
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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 six months ended June 30, 2022 and 2021 (in thousands):
Chargebacks, discounts, fees, and returns are recorded as reductions of accounts 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.
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License Revenue and Reimbursable Expenses |
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Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
License Revenue and Reimbursable Expenses | License Revenue and Reimbursable Expenses General The Company has generated revenue from contracts with customers, which include upfront payments for licenses. Teijin In July 2017, the Company entered into a License and Development Agreement (the “Teijin Agreement”) with Teijin Limited (“Teijin”) for abaloparatide for subcutaneous injection (“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, at Teijin’s request, to have 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. The Company also maintains full global rights to the abaloparatide-coated transdermal system product (“abaloparatide-TD”) that we are developing with Kindeva Drug Delivery (“Kindeva”), which is not currently 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. The Company assessed this arrangement in accordance with Topic 606 and concluded that the contract counterparty, Teijin, is a customer. The Company identified the following material promises under the contract: the commercialization and manufacturing licenses under certain intellectual property rights relating to abaloparatide-SC in Japan, as well as the right of reference to certain regulatory information. In addition, the Company identified the following customer option that would create an obligation for the Company if exercised by Teijin - the transfer of manufacturing know-how. The customer option for the transfer of manufacturing know-how represents a material right. Finally, the Company also identified the following customer option that would create a manufacturing obligation for the Company if exercised by Teijin - the supply of abaloparatide-SC for Teijin’s clinical trial needs. The customer option for clinical supply of abaloparatide-SC does not represent a material right. Based on these assessments, the Company identified the (i) commercialization and manufacturing licenses, as well as the right of reference to certain regulatory information, and (ii) transfer of manufacturing know-how as the only performance obligations at the inception of the arrangement, which were both deemed to be distinct. The Company further determined that the up-front payment of $10.0 million constituted the entirety of the consideration to be included in the transaction price, which was allocated to the performance obligations based on the Company’s best estimate of their relative stand-alone selling prices. For the commercialization and manufacturing licenses, including the right of reference to certain regulatory information, the stand-alone selling price was calculated using the expected cost approach by leveraging the direct costs incurred by the Company in its ACTIVExtend Phase 3 clinical trial for abaloparatide-SC, plus an estimated inflation rate. The stand-alone selling price of the transfer of manufacturing know-how was computed using a cost plus margin approach reflecting the level of effort required, which can be reasonably estimated to be incurred over the performance period, multiplied by a fully-burdened internal labor rate plus an expected margin. Based on the estimates of the stand-alone selling prices for each of the performance obligations, as referenced above, the Company determined that substantially all of the $10.0 million transaction price should be allocated to the performance obligation for the commercialization and manufacturing licenses, including the right of reference to certain regulatory information. The consideration allocated to the performance obligation for the transfer of manufacturing know-how was immaterial. The Company believes that a change in the assumptions used to determine its best estimate of the selling price for the commercialization and manufacturing licenses, including the right of reference to certain regulatory information, would not have a significant effect on the allocation of the underlying consideration to the performance obligations. Upon execution of the Teijin Agreement, the transaction price included only the $10.0 million up-front payment owed to the Company. As referenced above, the Company has received and 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. The regulatory milestone, which represents variable consideration that was evaluated under the most likely amount method, was not included in the transaction price, because the amount was fully constrained. As part of its evaluation of the constraint, the Company considered numerous factors, including that receipt of the milestone was outside the control of the Company. Any consideration related to sales-based milestones as well as royalties on net sales upon commercialization by Teijin, will be recognized when the related sales occur as they were determined to relate predominantly to the licenses granted to Teijin and, therefore, have also been excluded from the transaction price in accordance with the sales-based royalty exception. The Company will re-evaluate the transaction price in each reporting period, as uncertain events are resolved, or as other changes in circumstances occur. In March 2021, Teijin received approval for Ostabaro® abaloparatide acetate for the treatment of osteoporosis and for promotion of bone formation in both female and male patients with high risk fracture. Upon achievement of this regulatory milestone the Company received a payment of $10.0 million from Teijin, which was recognized as license revenue during the three months ended June 30, 2021. Berlin-Chemie In July 2020, the Company entered into to a license agreement (“License Agreement”) with Berlin-Chemie under which the Company granted Berlin-Chemie an exclusive license to develop and commercialize products containing elacestrant (RAD1901) worldwide. The Company and Berlin-Chemie simultaneously entered into a Transition Services Agreement (the “TSA”), pursuant to which the Company has agreed to perform certain services for Berlin-Chemie related to the EMERALD Phase 3 monotherapy study until the earlier of the completion of the contemplated services or the filing with the FDA of a NDA for elacestrant. Following submission of the NDA for elacestrant in patients with ER+/HER2- advanced or metastatic breast cancer, the Company no longer has any obligations to perform services for Berlin-Chemie. Pursuant to the TSA as amended in June 2022, Berlin-Chemie agreed to reimburse the Company for all out-of-pocket and full-time employee costs in performing the services, for total estimated reimbursements of $109.7 million of which $90.8 million has been reimbursed through June 30, 2022. Pursuant to the terms of the License Agreement, Berlin-Chemie made a nonrefundable initial license fee payment to the Company of $30.0 million in July 2020. The Company is also eligible to receive up to $20.0 million in development and regulatory milestone payments and up to $300.0 million in sales milestone payments, with such payments contingent on the achievement of specified milestones with respect to the licensed products. The Company is also eligible to receive tiered royalties on sales of licensed products at percentages ranging from low to mid-teens, subject to certain reductions. Royalties on net sales will be payable on a product-by-product and country-by-country basis until the latest of the expiration date of the last to expire of the relevant patent rights, the expiration of regulatory exclusivity, or ten years from such first commercial sale. The License Agreement will continue on a licensed product-by-licensed product and country-by-country basis until the last to expire royalty term. Either party may terminate the License Agreement for an uncured material breach by the other party or upon the bankruptcy or insolvency of the other party. The Company may terminate the License Agreement for certain patent challenges or if no development, manufacture or commercialization activity occurs in any given 24-month period. Berlin-Chemie may terminate the License Agreement at its discretion for any reason by delivering 180 days’ prior written notice to the Company; provided that such termination will not be effective prior to the third anniversary of the effective date. The Company determined that the License Agreement and TSA should be combined and evaluated as a single arrangement as they were executed on the same date and negotiated as a package. The arrangement with Berlin-Chemie provides for the transfer of the following goods or services: (i) license, (ii) know-how, (iii) regulatory filings, (iv) inventory, (v) transition services, including certain clinical, manufacturing, regulatory and other services associated with the Phase 3 EMERALD monotherapy study, and (vi) participation in various joint committees. Management applied the guidance in ASC 606 to identify all distinct goods and services within the arrangement to assess whether there is a unit of account that should be accounted for under ASC 606. Management evaluated all of the promised goods or services within the contract and determined which of those were separate performance obligations. The Company determined that the license granted, at arrangement inception, should be combined with the know-how and regulatory filings as they are not capable of being distinct (the “License”). The Company also concluded that the license rights, know-how, and regulatory filings are capable of being distinct from the supply of inventory, as Berlin-Chemie would be able to benefit from the inventory on its own or with other resources that are readily available, and capable of being distinct from the transition services and participation in joint committees as these are research and development services that can typically be performed by other third parties. The License and the initial transfer of inventory are elements of the arrangement that are subject to the revenue recognition accounting guidance, as the performance obligations are an output of the Company’s ordinary activities in exchange for consideration. Conversely, the transition services, and the participation on joint committees are elements of the arrangements that are outside the scope of the revenue recognition guidance, as the Company is providing goods and services that are not an output of the Company’s ordinary activities. The transaction price at inception was comprised of fixed consideration of $30.0 million. The $30.0 million upfront fee, which represents the fixed consideration in the transaction price, was allocated to the License and the supply of inventory, on a relative standalone selling price basis. The Company estimated the standalone selling price for the License by applying a risk adjusted, net present value, estimate of future potential cash flows approach and determined the standalone selling price for the inventory using a cost approach. Accordingly, the Company has allocated $27.4 million to the License and $2.6 million to the inventory. The Company concluded that the reimbursements for the research and development transition services and participation in the joint steering committees was commensurate with the standalone selling prices of the services, and as such, will be attributed to those services. The reimbursements for these services are recorded as a reduction of the related research and development expenses as the expenses are incurred. Under the Berlin-Chemie agreements, the Company is eligible to receive various development and regulatory, and sales milestones. In June 2022, Berlin-Chemie, with support from the Company, submitted an NDA to the FDA for elacestrant in patients with ER+/HER2- advanced or metastatic breast cancer, which submission triggered one of the three development and commercialization milestones. Accordingly, the Company recorded $5.0 million in License revenue during the three months ended June 30, 2022 that is payable within 60 days after achievement of the milestone. There is uncertainty that the remaining events to obtain the development and regulatory milestones will be achieved. The Company has thus determined that all such milestones will be constrained until it is deemed probable that a significant revenue reversal will not occur. Additional transaction price recognized in future periods related to milestone payments and royalties will be allocated solely to the License. Sales milestones and sales-based royalties were also excluded from the transaction price as the License is deemed to be the predominant item to which the sales milestones and sales-based royalties relate. The Company will recognize such revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). During the three and six months ended June 30, 2022 and 2021, the Company recorded $9.6 million and $18.7 million for the three and six months ended June 30, 2022, respectively, and $18.5 million and $32.8 million for the three and six months ended June 30, 2021, respectively, as reductions of research and development expenses for reimbursement of transition services performed under the TSA. As of June 30, 2022 and December 31, 2021, the Company had receivable balances of $12.2 million and $11.8 million, respectively, related to reimbursable research and development expenses under this agreement, which is presented in other current assets on the condensed consolidated balance sheet. The Company also had a license receivable of $5.0 million related to achievement of milestones under the License Agreement, which is presented in License receivables on the condensed consolidated balance sheet.
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Commitments and Contingencies |
6 Months Ended |
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Jun. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Litigation From time to time, the Company may become subject to legal proceedings and claims which arise in the ordinary course of its business. The Company records a liability in its condensed 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 condensed 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 June 30, 2022, the Company was not party to any significant litigation. Kindeva The Company was, until June 10, 2022, a party to a Scale-Up and Commercial Supply Agreement (the “Supply Agreement”) with Kindeva Drug Delivery (“Kindeva”) as successor to 3M Company and 3M Innovative Properties Company (collectively with 3M Company, “3M”), pursuant to which Kindeva agreed to exclusively manufacture Phase 3 and global commercial supplies of an abaloparatide-coated transdermal system (“abaloparatide-TD”). Under the Supply Agreement, Kindeva manufactured abaloparatide-TD for the Company according to agreed-upon specifications in sufficient quantities to meet the Company’s projected supply requirements. If abaloparatide-TD is commercialized, Kindeva would have manufactured commercial supplies of abaloparatide-TD at unit prices that decrease with an increase in the quantity the Company orders. The Company would have paid Kindeva a mid-to-low single-digit royalty on worldwide net sales of abaloparatide-TD and reimburse Kindeva for certain capital expenditures incurred to establish commercial supply of abaloparatide-TD. The Company was responsible for providing, at its expense, supplies of abaloparatide drug substance to be used in manufacturing abaloparatide-TD. During the term of the Supply Agreement, Kindeva and the Company 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 December 2021, the Company announced the results of its Phase 3 clinical trial for abaloparatide-TD whereby the wearABLe Trial did not meet its primary or secondary endpoints. Based upon both the Company’s internal analysis and regulatory feedback from the FDA on possible paths forward for abaloparatide-TD, in June 2022 the Company announced the decision to cease all work on abaloparatide-TD, and the Company terminated the Supply Agreement effective June 10, 2022 as permitted within the terms of the contract which allows for the Company to terminate the Supply Agreement upon the occurrence of certain events, including if the Company ceased development or commercialization of abaloparatide-TD. As a result, the Company recorded approximately $3.2 million in expenses related to the termination of the abaloparatide-TD program. The Company has paid 3M and Kindeva approximately $70.9 million, in the aggregate, through June 30, 2022 with respect to performance under the Supply Agreement. Until June 2022, the Company was a party to the Development and Clinical Supplies Agreement with 3M, as amended (the “Development Agreement”), under which abaloparatide-TD development activities occurred and 3M manufactured phase 1 and 2 clinical trial supplies on an exclusive basis. The initial term of the Development Agreement remained in effect until June 2022 when the Supply Agreement was terminated. The Company has paid 3M and Kindeva approximately $31.8 million, in the aggregate, through June 30, 2022 with respect to performance under the Development Agreement. Manufacturing Agreements The Company is a party to a Supply Agreement with Ypsomed AG (“Ypsomed”), as amended, pursuant to which Ypsomed has 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 has 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 to pay a one-time capacity fee. All costs and payments under the agreement are delineated in Swiss Francs. The agreement had an initial term of three years, which began on June 1, 2017, after which it automatically renewed for a two-year term. Following its current term, the agreement automatically renews for additional two-year terms unless either party terminates the agreement upon 18 months’ notice prior to the end of the then-current term. During the two-year term beginning May 2020, the Company is required to purchase a minimum number of batches for CHF 1.9 million (approximately $2.0 million). The Company is also a party to a Commercial Supply Agreement with Vetter Pharma International GmbH (“Vetter”), as amended, pursuant to which Vetter has agreed to formulate the finished abaloparatide-SC drug product containing abaloparatide, the API, to fill cartridges with the drug product, to assemble the pen delivery device, and to package the pen for commercial distribution. The Company has agreed to purchase the cartridges and pens in specified batch sizes at a price per unit. For labeling and packaging services, the Company has 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 term of the agreement automatically renewed on January 1, 2021 for an additional two-year term and will automatically renew for additional two-year terms thereafter, unless either party notifies the other party two years before the end of the then-current term that it does not intend to renew. The Company is also a party to a Manufacturing Services Agreement with Polypeptide Laboratories Holding AB (“PPL”), as amended, as successor-in-interest to Lonza Group Ltd., pursuant to which PPL has agreed to manufacture the commercial and clinical supplies of the API for abaloparatide. The Company has agreed to purchase the API in batches at a price per gram in euros, subject to an annual increase by PPL. The Company is also required to purchase a minimum number of batches annually, equal to €2.9 million (approximately $3.0 million) per year and $17.2 million in total through the year ended December 31, 2022. 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. Asset Purchase Agreement In December 2020, the Company entered into an Asset Purchase Agreement with Fresh Cut Development, LLC and Benuvia Therapeutics Inc. for the acquisition of certain assets related to formulations of cannabidiol (“CBD”) related to the oral administration of a liquid formulation of CBD for therapeutic use in humans or animals (“RAD011”). Under the terms of the agreement, the Company may be obligated to make additional payments of up to $60.0 million in future periods, which would become due and payable only upon the achievement of certain development milestones. In addition, the Company may be obligated to pay up to $30.0 million in sales milestones contingent upon the realization of sales revenues and sublicense revenue. As of June 30, 2022, the Company has a liability of $2.5 million, related to certain development milestones that were deemed probable of achievement.
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Income Taxes |
6 Months Ended |
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Jun. 30, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income TaxesThe Company did not record a federal or state income tax provision or benefit for each of the six months ended June 30, 2022 and 2021 due to the expected loss before income taxes to be incurred for the years ended December 31, 2022 and 2021, as well as the Company’s continued maintenance of a full valuation allowance against its net deferred tax assets. |
Subsequent Events |
6 Months Ended |
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Jun. 30, 2022 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent Events In July 2022, the Company and Teijin entered into the Amended License and Development Agreement (the “Amended Teijin Agreement”) and concurrently executed a Commercial Supply Agreement (the “Teijin Supply Agreement” and together with the Amended Teijin Agreement, the “Teijin Development and Supply Agreements”). The Amended Teijin Agreement amended the terms of the Teijin Agreement referenced in Note 9. The Teijin Agreement has been amended to remove references to the joint commercialization opportunity and to waive the royalty on net sales of any abaloparatide-SC purchased by Teijin through the Teijin Supply Agreement. The Teijin Development and Supply Agreements does not have any impact on royalties owed on sales of abaloparatide-SC not purchased through the Teijin Supply Agreement, and accordingly, for any abaloparatide-SC sold by Teijin but not purchased through the Teijin Supply Agreement, royalty payments will be owed by Teijin to the Company under the Teijin Agreement referenced in Note 9 in consideration for the license granted by the Company to Teijin thereunder. Under the Teijin Supply Agreement, the Company will supply to Teijin, and Teijin will purchase from the Company, a finished product comprising of a cartridge filled with abaloparatide-SC. Specifically, the Company will purchase, for Teijin, the abaloparatide-SC from a material supplier and then have a commercial supplier fill the cartridges with abaloparatide-SC and supply final abaloparatide-SC for commercialization and distribution by Teijin in Japan. As consideration, the Company will receive an annual fee and a per-unit supply price for all abaloparatide-SC purchased by Teijin through the Company under the Teijin Supply Agreement. Any other costs borne by the Company for the purchase of abaloparatide-SC or manufacture of the abaloparatide-SC will be reimbursed by Teijin. The Company has also agreed under the Teijin Supply Agreement, in the event of any breach of the supply agreement by the commercial supplier resulting in the Company’s breach of the Teijin Supply Agreement, to pursue any potential claims against commercial supplier on behalf of Teijin to the extent required under the Teijin Supply Agreement.The Teijin Supply Agreement will remain in effect, unless terminated earlier for breach, until the earlier of the expiration or termination of the Teijin Agreement, the expiration or termination of the Company’s commercial supply agreement with the commercial supplier, or termination by either party in the event of the other party’s bankruptcy.
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Basis of Presentation and Significant Accounting Policies (Policies) |
6 Months Ended |
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Jun. 30, 2022 | |
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, revenue, expenses and related disclosures at the date of the financial statements. Actual results could differ from those estimates. Additionally, operating results for the three and six months ended June 30, 2022 are not necessarily indicative of the results that may be expected for any other interim period or for the fiscal year ending December 31, 2022. 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, 2021, filed with the Securities and Exchange Commission (“SEC”) on February 24, 2022. Significant Accounting Policies The significant accounting policies identified in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 that require the Company to make estimates and assumptions include: revenue recognition, inventory obsolescence, long-lived assets and intangible assets, accounting for share-based compensation, contingencies, tax valuation reserves, fair value measures, and accrued expenses. There were no changes to significant accounting policies during the six months ended June 30, 2022.
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Recent Accounting Standards Not Yet Adopted | Recent Accounting Standards Not Yet AdoptedThere are no applicable material accounting pronouncements recently issued that have not yet been adopted by the Company. |
Fair Value Measurements (Tables) |
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Fair Value Disclosures [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule 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 as of June 30, 2022 and December 31, 2021 (in thousands):
(1) Fair value is based upon quoted market prices.
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Inventory (Tables) |
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Jun. 30, 2022 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Inventory Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Inventory | Inventory consisted of the following as of June 30, 2022 and December 31, 2021 (in thousands):
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Convertible Notes Payable (Tables) |
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Debt Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Outstanding Balances of Convertible Notes | The outstanding balances of the Convertible Notes as of June 30, 2022 consisted of the following (in thousands):
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Schedule of Interest Expense Recognized Related to Debt | The following table sets forth total interest expense recognized related to the Convertible Notes during the three months and six ended June 30, 2022 and 2021 (in thousands):
The following table sets forth total interest expense recognized related to the Term Facility during the three and six months ended June 30, 2022 and 2021 (in thousands):
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Schedule of Future Minimum Payments on Long-Term Debt | Future minimum payments on the Company’s Convertible Notes as of June 30, 2022 are as follows (in thousands):
Future minimum payments on the Term Facility as of June 30, 2022 are as follows (in thousands):
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Term Loan and Credit Facilities (Tables) |
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Debt Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Carrying Values of Debt Instruments | The outstanding balance of the Term Loan as of June 30, 2022 consisted of the following (in thousands):
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Schedule of Interest Expense Recognized Related to Debt | The following table sets forth total interest expense recognized related to the Convertible Notes during the three months and six ended June 30, 2022 and 2021 (in thousands):
The following table sets forth total interest expense recognized related to the Term Facility during the three and six months ended June 30, 2022 and 2021 (in thousands):
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Schedule of Future Minimum Payments on Long-Term Debt | Future minimum payments on the Company’s Convertible Notes as of June 30, 2022 are as follows (in thousands):
Future minimum payments on the Term Facility as of June 30, 2022 are as follows (in thousands):
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Net Loss Per Share (Tables) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2022 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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 six months ended June 30, 2022 and 2021, respectively, all of the Company’s options to purchase common stock, restricted stock units outstanding, and performance options were assumed to be anti-dilutive as earnings attributable to common stockholders was in a loss position.
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Product Revenue Reserves and Allowances (Tables) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2022 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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 six months ended June 30, 2022 and 2021 (in thousands):
|
Organization (Details) - USD ($) $ / shares in Units, $ in Thousands |
Jun. 30, 2022 |
Dec. 31, 2021 |
---|---|---|
Condensed Financial Statements, Captions [Line Items] | ||
Accumulated deficit | $ (1,398,990) | $ (1,367,981) |
Cash, cash equivalents, marketable securities, and investments | $ 72,500 | |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Gurnet Point Capital | Radius Health, Inc. | ||
Condensed Financial Statements, Captions [Line Items] | ||
Acquisition price per share (in dollars per share) | 10.00 | |
Common stock, par value (in dollars per share) | $ 1.00 | |
Net sales | $ 300,000 | |
Revolving Credit Facility | Line of Credit | ||
Condensed Financial Statements, Captions [Line Items] | ||
Maximum borrowing capacity (up to) | $ 25,000 |
Inventory (Details) - USD ($) $ in Thousands |
6 Months Ended | |
---|---|---|
Jun. 30, 2022 |
Dec. 31, 2021 |
|
Inventory Disclosure [Abstract] | ||
Raw materials | $ 7,716 | $ 7,159 |
Work in process | 1,377 | 1,335 |
Finished goods | 3,398 | 2,879 |
Total inventories | $ 12,491 | $ 11,373 |
Finished goods shelf life (in months) | 36 months |
Convertible Notes Payable - Summary of Outstanding Balances of Convertible Notes (Details) - Convertible debt - 3.00% Convertible notes $ in Thousands |
Jun. 30, 2022
USD ($)
|
---|---|
Debt Instrument [Line Items] | |
Principal | $ 192,753 |
Less: debt discount and issuance costs | (1,861) |
Net carrying amount | $ 190,892 |
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 | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2022 |
Jun. 30, 2021 |
Jun. 30, 2022 |
Jun. 30, 2021 |
|
Debt Instrument [Line Items] | ||||
Contractual interest expense | $ 1,446 | $ 1,446 | $ 2,892 | $ 3,602 |
Amortization of debt discount | 195 | 196 | 391 | 489 |
Amortization of debt issuance costs | 11 | 11 | 22 | 26 |
Total interest expense | $ 1,652 | $ 1,653 | $ 3,305 | $ 4,117 |
Convertible Notes Payable - Schedule of Future Minimum Payments on Long-Term Debt (Details) - Convertible debt - 3.00% Convertible notes $ in Thousands |
Jun. 30, 2022
USD ($)
|
---|---|
Future Minimum Payments | |
2022 (excluding the 6 months ended June 30, 2022) | $ 2,891 |
2023 | 5,783 |
2024 | 198,535 |
Total minimum payments | 207,209 |
Less: interest | (14,456) |
Less: unamortized discount | (1,861) |
Net carrying amount | $ 190,892 |
Term Loan and Credit Facilities - Carrying Value (Details) - Medium-term Notes - Term Facility - USD ($) |
Jun. 30, 2022 |
Mar. 03, 2021 |
---|---|---|
Debt Instrument [Line Items] | ||
Principal | $ 150,000,000 | |
Debt Instrument, Tranche One | ||
Debt Instrument [Line Items] | ||
Principal | $ 150,000,000 | |
Less: debt issuance costs | (1,319,000) | |
Net carrying amount | $ 148,681,000 |
Term Loan and Credit Facilities - Interest Expense (Details) - Debt Instrument, Tranche One - Medium-term Notes - Term Facility - USD ($) $ in Thousands |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2022 |
Jun. 30, 2021 |
Jun. 30, 2022 |
Jun. 30, 2021 |
|
Debt Instrument [Line Items] | ||||
Contractual interest expense | $ 2,968 | $ 2,939 | $ 5,929 | $ 3,976 |
Amortization of debt discount | 208 | 208 | 416 | 256 |
Total interest expense | $ 3,176 | $ 3,147 | $ 6,345 | $ 4,232 |
Term Loan and Credit Facilities - Future Minimum Payments (Details) - Debt Instrument, Tranche One - Medium-term Notes - Term Facility $ in Thousands |
Jun. 30, 2022
USD ($)
|
---|---|
Debt Instrument [Line Items] | |
2022 (excluding the 6 months ended June 30, 2022) | $ 5,813 |
2023 | 61,302 |
2024 | 102,260 |
Total minimum payments | 169,375 |
Less: interest | (19,375) |
Less: unamortized issuance costs | (1,319) |
Term loan | $ 148,681 |
Net Loss Per Share - Basic and Diluted (Details) - USD ($) $ / shares in Units, $ in Thousands |
3 Months Ended | 6 Months Ended | ||||
---|---|---|---|---|---|---|
Jun. 30, 2022 |
Mar. 31, 2022 |
Jun. 30, 2021 |
Mar. 31, 2021 |
Jun. 30, 2022 |
Jun. 30, 2021 |
|
Numerator: | ||||||
Net loss | $ (12,733) | $ (18,276) | $ (16,810) | $ (15,749) | $ (31,010) | $ (32,559) |
Denominator: | ||||||
Weighted-average number of common shares used in loss per share - basic (in shares) | 47,588,158 | 47,391,530 | 47,515,394 | 47,114,947 | ||
Weighted-average number of common shares used in loss per share - diluted (in shares) | 47,588,158 | 47,391,530 | 47,515,394 | 47,114,947 | ||
Loss per share - basic (in dollars per share) | $ (0.27) | $ (0.35) | $ (0.65) | $ (0.69) | ||
Loss per share - diluted (in dollars per share) | $ (0.27) | $ (0.35) | $ (0.65) | $ (0.69) |
Label | Element | Value |
---|---|---|
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