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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
FORM 10-Q
 
xQUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
For the quarterly period ended September 30, 2017March 31, 2022
Or
oTRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
For the transition period from              to             .
 
Commission File Number 001-35726
 
Radius Health, Inc.
(Exact name of registrant as specified in its charter)
Delaware80-0145732
(State or other jurisdiction of(IRSI.R.S. Employer
Incorporationincorporation or organization)Identification Number)No.)
 
950 Winter Street22 Boston Wharf Road, 7th Floor
Waltham,Boston, Massachusetts 0245102210
(Address of Principal Executive Offices and Zip Code)
 
(617) 551-4000
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
Title of each classTrading Symbol(s)Name of each exchange on which registered
Common Stock, $0.0001 par value per shareRDUSThe Nasdaq Global Market
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.  Yes x   No o

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Website, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).  Yes x   No o

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and "emerging“emerging growth company"company” in Rule 12b-2 of the Exchange Act.
Large accelerated filerAccelerated filer 
Non-accelerated filer Smaller reporting company 
Large accelerated filer x
Accelerated filer o
Non-accelerated filer o
Smaller reporting company o
Emerging growth company o


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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  o
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).  Yes o   No x


Number of shares of the registrant’s Common Stock, $.0001$0.0001 par value per share, outstanding as of October 30, 2017: 44,591,841 May 2, 2022: 47,570,107 shares



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RADIUS HEALTH, INC.
FORM 10-Q
FOR THE QUARTER ENDED SEPTEMBER 30, 2017
MARCH 31, 2022
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PART I— FINANCIAL INFORMATION
Item 1. Condensed Consolidated Financial Statements

Radius Health, Inc.
Condensed Consolidated Balance Sheets
(InUnaudited, in thousands, except share and per share amounts)
September 30,
2017
 December 31,
2016
March 31,
2022
December 31,
2021
(unaudited)   (unaudited) 
ASSETS 
  
ASSETS  
Current assets: 
  
Current assets:  
Cash and cash equivalents$446,938
 $258,567
Cash and cash equivalents$71,615 $111,533 
Restricted cash47
 47
Restricted cash567 567 
Marketable securities21,144
 73,880
Accounts receivable, net11,682
 
Accounts receivable, net30,280 23,355 
Inventory3,074
 
Inventory13,296 11,373 
Prepaid expenses and other current assets7,808
 2,315
Prepaid expensesPrepaid expenses16,273 10,050 
Other current assetsOther current assets13,738 16,201 
Total current assets490,693
 334,809
Total current assets145,769 173,079 
Property and equipment, net7,306
 4,922
Property and equipment, net763 647 
Intangible assets8,380
 
Intangible assets4,787 4,986 
Right of use assets - operating leasesRight of use assets - operating leases981 835 
Other assets558
 551
Other assets1,848 1,995 
Total assets$506,937
 $340,282
Total assets$154,148 $181,542 
   
LIABILITIES AND STOCKHOLDERS’ EQUITY 
  
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)  
Current liabilities: 
  
Current liabilities:  
Accounts payable$3,714
 $6,128
Accounts payable$15,791 $17,625 
Accrued expenses and other current liabilities34,411
 26,597
Accrued expenses and other current liabilities64,164 76,549 
Operating lease liability, currentOperating lease liability, current508 613 
Total current liabilities38,125
 32,725
Total current liabilities80,463 94,787 
Convertible notes payableConvertible notes payable190,686 190,479 
Term loanTerm loan148,473 148,265 
Operating lease liability, long termOperating lease liability, long term473 315 
Total liabilitiesTotal liabilities420,095 433,846 
   
Other non-current liabilities213
 379
Note payable162,759
 
Total liabilities$201,097
 $33,104
Commitments and contingencies

 

Stockholders’ equity: 
  
Common stock, $.0001 par value; 200,000,000 shares authorized, 44,531,913 shares and 43,141,134 shares issued and outstanding at September 30, 2017 and December 31, 2016, respectively4
 4
Stockholders’ equity (deficit):Stockholders’ equity (deficit):  
Common stock, 0.0001 par value; 200,000,000 shares authorized, 47,564,764 shares and 47,359,573 shares issued and outstanding at March 31, 2022 and December 31, 2021Common stock, 0.0001 par value; 200,000,000 shares authorized, 47,564,764 shares and 47,359,573 shares issued and outstanding at March 31, 2022 and December 31, 2021
Additional paid-in-capital1,117,101
 935,671
Additional paid-in-capital1,120,299 1,115,672 
Accumulated other comprehensive income2
 71
Accumulated other comprehensive income— 
Accumulated deficit(811,267) (628,568)Accumulated deficit(1,386,257)(1,367,981)
Total stockholders’ equity305,840
 307,178
Total liabilities and stockholders’ equity$506,937
 $340,282
Total stockholders’ equity (deficit)Total stockholders’ equity (deficit)$(265,947)(252,304)
Total liabilities and stockholders’ equity (deficit)Total liabilities and stockholders’ equity (deficit)$154,148 $181,542 
See accompanying notes to unaudited condensed consolidated financial statements.




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Radius Health, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited, in thousands, except share and per share amounts)
Three Months Ended
March 31,
 20222021
REVENUES:
Product revenue, net$42,958 $45,261 
License revenue200 11,000 
Total revenue$43,158 $56,261 
OPERATING EXPENSES:  
Cost of sales - product4,060 3,925 
Cost of sales - intangible amortization200 200 
Research and development, net of amounts reimbursable (a)22,697 31,440 
Selling, general and administrative30,048 34,097 
Loss from operations(13,847)(13,401)
OTHER INCOME (EXPENSE):  
Other income (expense)379 (1)
Interest expense(4,822)(4,364)
Interest income14 57 
Gain on extinguishment of debt— 1,960 
NET LOSS$(18,276)$(15,749)
OTHER COMPREHENSIVE LOSS:  
Foreign currency gain— 
Unrealized loss from available-for-sale debt securities— (21)
COMPREHENSIVE LOSS$(18,270)$(15,770)
LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS - BASIC AND DILUTED (Note 7)$(18,276)$(15,749)
LOSS PER SHARE:  
Basic and diluted$(0.39)$(0.34)
WEIGHTED AVERAGE SHARES:  
Basic and diluted47,441,821 46,981,016 
(a) Amounts reimbursable were $9.1 million and $14.3 million for the three months ended March 31, 2022 and 2021, respectively.
 Three Months Ended
September 30,
 Nine Months Ended
September 30,
 2017 2016 2017 2016
REVENUES:       
Product revenue, net$3,469
 $
 $4,449
 $
License revenue10,000
 
 10,000
 
OPERATING EXPENSES: 
  
    
Cost of sales - product253
 
 358
 
Cost of sales - intangible amortization200
 
 200
 
Research and development20,997
 27,453
 60,176
 81,827
Selling, general and administrative47,723
 19,240
 135,943
 50,079
Loss from operations(55,704) (46,693) (182,228) (131,906)
OTHER (EXPENSE) INCOME: 
  
  
  
Other expense, net(195) (78) (212) (174)
Interest expense(2,763) 
 (2,763) 
Interest income819
 585
 1,983
 1,996
NET LOSS$(57,843) $(46,186) $(183,220) $(130,084)
OTHER COMPREHENSIVE LOSS: 
  
  
  
Unrealized (loss) gain from available-for-sale securities(1) (136) (70) 47
COMPREHENSIVE LOSS$(57,844) $(46,322) $(183,290) $(130,037)
LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS - BASIC AND DILUTED (Note 10)$(57,843) $(46,186) $(183,220) $(130,084)
LOSS PER SHARE: 
  
  
  
Basic and diluted$(1.31) $(1.07) $(4.21) $(3.02)
        
WEIGHTED AVERAGE SHARES: 
  
  
  
Basic and diluted43,999,451
 43,092,921
 43,535,874
 43,049,734

See accompanying notes to unaudited condensed consolidated financial statements.




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Radius Health, Inc.
Condensed Consolidated Statements of Stockholders’ Equity (Deficit)
(Unaudited, in thousands, except share and per share amounts)
 Stockholders’ Equity (Deficit)
 Common StockAdditional Paid-In Capital 
Accumulated Other
Comprehensive Income
(Loss)
 Accumulated
Deficit
Total Stockholders’ Equity (Deficit)
 SharesAmountAmount Amount AmountAmount
Balance at December 31, 202046,779,479 $$1,222,137 $21 $(1,345,822)$(123,659)
Adjustment due to adoption of ASU 2020-06(134,450)48,017 (86,433)
Net loss(15,749)(15,749)
Unrealized loss from available-for-sale securities(21)(21)
Vesting of restricted shares202,018 — 
Exercise of options193,300 3,764 3,764 
Issuance of common stock upon purchase by employee stock purchase plan66,301 678 678 
Share-based compensation expense5,410 5,410 
Balance at March 31, 202147,241,098 $$1,097,539 $— $(1,313,554)$(216,010)
Balance at December 31, 202147,359,573 $$1,115,672 $— $(1,367,981)$(252,304)
Net loss(18,276)(18,276)
Foreign currency gain
Vesting of restricted shares139,056 — 
Share-based compensation expense related to share-based awards for employee stock purchase plan113 113 
Issuance of common stock upon purchase by employee stock purchase plan66,135 482 482 
Share-based compensation expense4,032 4,032 
Balance at March 31, 202247,564,764 $$1,120,299 $$(1,386,257)$(265,947)
See accompanying notes to unaudited condensed consolidated financial statements.











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Radius Health, Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited, in thousands)
Nine Months Ended
September 30,
Three Months Ended
March 31,
2017 2016 20222021
CASH FLOWS USED IN OPERATING ACTIVITIES: 
  
CASH FLOWS USED IN OPERATING ACTIVITIES:  
Net loss$(183,220) $(130,084)Net loss$(18,276)$(15,749)
Adjustments to reconcile net loss to net cash used in operating activities: 
  
Adjustments to reconcile net loss to net cash used in operating activities:  
Depreciation and amortization1,385
 371
Depreciation and amortization387 251 
Amortization of premium (discount) on marketable securities, net(100) 797
Amortization of premium/discount on marketable securities, netAmortization of premium/discount on marketable securities, net— 19 
Amortization of debt discount and debt issuance costs1,568
 
Amortization of debt discount and debt issuance costs415 358 
Stock-based compensation28,785
 18,702
Share-based compensationShare-based compensation4,145 5,410 
Gain on extinguishment of debtGain on extinguishment of debt— (1,960)
Changes in operating assets and liabilities: 
  
Changes in operating assets and liabilities:  
Inventory(3,074) 
Inventory(1,923)(256)
Accounts receivable, net(11,682) 
Accounts receivable, net(6,925)(5,995)
Prepaid expenses and other current assets(5,493) 3,308
Other long-term assets(7) (291)
Prepaid expensesPrepaid expenses(6,223)(1,012)
Other current assetsOther current assets2,463 (7,465)
Operating lease right of use assetsOperating lease right of use assets150 358 
Accounts payable(2,414) (3,563)Accounts payable(1,828)(2,143)
Deferred revenueDeferred revenue— (1,000)
Accrued expenses and other current liabilities7,327
 7,284
Accrued expenses and other current liabilities(12,385)10,693 
Other non-current liabilities(166) 402
Lease liability, operating leasesLease liability, operating leases(243)(622)
Net cash used in operating activities(167,091) (103,074)Net cash used in operating activities(40,243)(19,113)
CASH FLOWS (USED IN) PROVIDED BY INVESTING ACTIVITIES: 
  
CASH FLOWS PROVIDED BY INVESTING ACTIVITIES:CASH FLOWS PROVIDED BY INVESTING ACTIVITIES:  
Purchases of property and equipment(2,950) (2,125)Purchases of property and equipment(157)— 
Payments for capitalized milestones(8,712) 
Purchases of marketable securities(117,441) (225,497)
Sales and maturities of marketable securities170,208
 367,141
Sales and maturities of marketable securities— 23,240 
Net cash provided by investing activities41,105
 139,519
Net cash provided by investing activities(157)23,240 
CASH FLOWS PROVIDED BY FINANCING ACTIVITIES: 
  
CASH FLOWS PROVIDED BY FINANCING ACTIVITIES:  
Proceeds from exercise of stock options16,167
 2,442
Proceeds from exercise of stock options— 3,764 
Proceeds from issuance of convertible debt305,000
 
Payment of debt issuance costs(9,360) 
Proceeds from issuance of term loan, net of issuance costsProceeds from issuance of term loan, net of issuance costs— 122,687 
Repurchase of convertible notesRepurchase of convertible notes— (108,568)
Proceeds from issuance of shares under employee stock purchase plan2,550
 
Proceeds from issuance of shares under employee stock purchase plan482 678 
Net cash provided by financing activities314,357
 2,442
Net cash provided by financing activities482 18,561 
NET INCREASE IN CASH AND CASH EQUIVALENTS188,371
 38,887
CASH AND CASH EQUIVALENTS AT BEGINNING OF YEAR258,567
 159,678
CASH AND CASH EQUIVALENTS AT END OF PERIOD$446,938
 $198,565
NET INCREASE IN CASH, CASH EQUIVALENTS, AND RESTRICTED CASHNET INCREASE IN CASH, CASH EQUIVALENTS, AND RESTRICTED CASH(39,918)22,688 
CASH, CASH EQUIVALENTS, AND RESTRICTED CASH AT BEGINNING OF PERIODCASH, CASH EQUIVALENTS, AND RESTRICTED CASH AT BEGINNING OF PERIOD112,100 92,003 
CASH, CASH EQUIVALENTS, AND RESTRICTED CASH AT END OF PERIODCASH, CASH EQUIVALENTS, AND RESTRICTED CASH AT END OF PERIOD$72,182 $114,691 
SUPPLEMENTAL DISCLOSURES: 
  
SUPPLEMENTAL DISCLOSURES:  
Cash paid for income taxes$26
 $
Property and equipment purchases in accrued expenses at period end$487
 $406
Cash paid for interestCash paid for interest$5,797 $4,936 
Cash paid for amounts included in the measurement of operating lease liabilitiesCash paid for amounts included in the measurement of operating lease liabilities$253 0
Right of use assets obtained in exchange for operating lease liabilityRight of use assets obtained in exchange for operating lease liability$488 0
See accompanying notes to unaudited condensed consolidated financial statements.



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Radius Health, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
1. Organization
Radius Health, Inc. (“Radius”Radius,” the “Company,” “us,” “our” or the “Company”“we”) is a science-driven fully integratedglobal biopharmaceutical company that is committed to developing and commercializing innovative therapeuticsfocused on addressing unmet medical needs in the areas of osteoporosis, oncologybone health, neuroscience, and endocrine diseases. Ononcology. In April 28, 2017, the Company'sCompany’s first commercial product, TYMLOSTM for subcutaneous (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. The Company's European Marketing Authorisation Application ("MAA")We are also developing certain assets we acquired related to formulations of cannabidiol related to the oral administration of a solution of CBD for abaloparatidetherapeutic use in humans or animals (“RAD011”), for subcutaneous injection ("abaloparatide-SC") is under review bywhich the CommitteeCompany intends to seek FDA approval for Medicinal Productsa Phase 2/3 trial for Human Usetreatment of hyperphagia behavior and weight loss in patients with Prader Willi syndrome (“PWS”). In October 2021, together with our licensee, Berlin-Chemie AG, a company of the EMA ("CHMP"Menarini Group (“Berlin-Chemie”). The Company's clinical pipeline includes an, we announced the receipt of positive top-line results from the EMERALD Phase 3 study of our investigational abaloparatide transdermal patch ("abaloparatide-TD") for potential use in the treatment of women with postmenopausal osteoporosis; the investigational drugproduct candidate elacestrant, (RAD1901), a selective estrogen receptor degrader for potential use in the treatment of hormone-receptor positive breast cancer, as well as for potential use in the treatment of vasomotor symptoms in postmenopausal women;(“SERD”). Berlin-Chemie holds an exclusive, worldwide license to develop and the investigational drug RAD140, a non-steroidal, selective androgen receptor modulator for potential use in the treatment of hormone-receptor positive breast cancer.commercialize products containing elacestrant.
The Company is subject to the risks associated with biopharmaceuticalcommon to companies with ain its industry including, but not limited operating history, includingto, the dependence on key individuals,revenues from a developing business model, the necessity of securingsingle commercialized product, competition, uncertainty about clinical trial outcomes and regulatory approvals, uncertainties relating to market its investigationalpharmaceutical pricing reimbursement, uncertain protection of proprietary technology and potential product candidates, market acceptance and the successful commercialization of TYMLOS, or any of the Company’s investigational product candidates following receipt of regulatory approval, competition for TYMLOS or any of the Company's investigational product candidates following receipt of regulatory approval, and the continued ability to obtain adequate financing to fund the Company’s future operations. The Company has incurred losses and expects to continue to incur additional losses for the foreseeable future.liability. As of September 30, 2017,March 31, 2022, the Company had an accumulated deficit of $811.3$1,386.3 million, and total cash and cash equivalents and marketable securities of $468.1$71.6 million.
Based upon its cash and cash equivalents balance and marketable securities balancethe $25.0 million secured revolving credit facility available to the Company under its Revolving Credit Agreement with MidCap Financial Trust as discussed in Note 6, “Term Loan and Credit Facility” as of September 30, 2017,March 31, 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, U.S. commercial activities and other operational activities for not less than twelve monthsat least one year from the date of this filing. The Company expects to finance its commercial activities in the United Statesongoing and development costs offuture operations with its clinical product portfolio with itsrevenue, existing cash and cash equivalents, and marketable securities, as well as future product sales or through strategic financing opportunities that could include, but are not limited to partnering or other collaboration agreements future offerings of its equity, royalty-based financing arrangements,or the incurrence of debt, or other alternative financing arrangements which may include a combination of the foregoing.debt. However, there is no guarantee that any of these strategic or financing opportunities will be executed or executed on favorable terms, and some could be dilutive to existing stockholders. If the Company fails to obtain additional capital, it may be unable to conduct its planned commercialization activities or complete its planned preclinical studies and clinical trials and obtain approval of certain investigational product candidates from the FDA or foreign regulatory authorities.
2. 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 ninethree months ended September 30, 2017March 31, 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, 2017.2022. 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 ourthe Company’s Annual Report on Form 10-K for the year ended December 31, 2016 (“2016 Form 10-K”),2021, filed with the Securities and Exchange Commission (“SEC”) on February 24, 2017.2022.

Certain prior period amounts have been reclassified to conform to the current period presentation.
Significant Accounting Policies—The significant accounting policies identified in the Company’s 2016Annual Report on Form 10-K for the year ended December 31, 2021 that require the Company to make estimates and assumptions include: researchrevenue recognition, inventory obsolescence, long-lived assets and development costs, stock-basedintangible assets, accounting for share-based compensation, andcontingencies, tax valuation reserves, fair value measures.measures, and accrued expenses. There were no changes to significant accounting policies during the ninethree months ended September 30, 2017, except for the adoption of two Accounting Standards Updates ("ASU") issued by the Financial Accounting Standards Board ("FASB"), as well as significant accounting policies over revenue, inventory, intangibles, and convertible debt each of which is detailed below.March 31, 2022.
Stock-based Compensation— In March 2016, the FASB issued ASU No. 2016-09, Improvements to Employee Share-Based Payment Accounting (“ASU 2016-09”). This revised standard affects the accounting for forfeitures, cash flow presentation and income taxes. Specifically, this standard provides an accounting policy election to account for forfeitures as they occur, requires all excess tax benefits and deficiencies on share-based payment awards to be recognized as income tax expense or benefit in the statement of operations, requires the tax effects of exercised or vested awards should be treated as discrete items in the reporting period in which they occur, and requires that excess tax benefits to be classified with other income tax cash flows as an operating activity. The standard permits early adoption in any annual or interim period and will be applied by means of a cumulative-effect adjustment to retained earnings as of the beginning of the fiscal year of adoption.
Historically, the Company recognized stock-based compensation net of estimated forfeitures over the vesting period of the respective grant. Effective January 1, 2017, the Company adopted ASU 2016-09 and changed its accounting policy to recognize forfeitures as they occur. The new forfeiture policy election was adopted using a modified retrospective approach with a cumulative effect adjustment ofapproximately $0.5 millionto retained earnings as of January 1, 2017. In addition, the Company recognized $6.1 million of accumulated excess tax benefits as deferred tax assets that under the previous guidance could not be recognized until the benefits were realized through a reduction in cash taxes paid. This part of the guidance was applied using a modified retrospective method with a cumulative-effect adjustment to the accumulated deficit for the excess tax benefits not previously recognized. However, given the full valuation allowance placed on the additional $6.1 million of deferred tax assets, the recognition upon adoption had no impact to our accumulated deficit as of January 1, 2016. The adoption of ASU 2016-09 effective January 1, 2017 had no other material impacts on the Company’s results of operations, financial position or cash flows.
Revenue RecognitionIn April 2017, the FDA approved TYMLOS. Subsequent to receiving FDA approval, the Company entered into a limited number of arrangements with wholesalers in the U.S. (collectively, its “Customers”) to distribute TYMLOS. Additionally, in July 2017, the Company entered into a License and Development Agreement (the “Teijin Agreement”) with Teijin Limited (“Teijin”) for abaloparatide-SC in Japan. These arrangements are the Company’s initial contracts with customers and, as such, were evaluated and accounted for in compliance with Accounting Standards Codification (“ASC”) Topic 606 - Revenue from Contracts with Customers (“Topic 606”), which was adopted during the quarter ended June 30, 2017. In connection therewith, there was no transition to Topic 606 because the Company has no historical revenue. This standard applies to all contracts with customers, except for contracts that are within the scope of other standards. Under Topic 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to be entitled in exchange for those goods or services.
To determine revenue recognition for arrangements that an entity determines are within the scope of Topic 606, the entity performs the following five steps: (i) identify the contract(s) with a customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations in the contract, and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to arrangements that meet the definition of a contract under Topic 606, including when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of Topic 606, the Company assesses the goods or services promised within each contract, determines those that are performance obligations, and assesses whether each promised good or service is distinct. For a complete discussion of accounting for product revenue, see Product Revenue, Net (below).
Product Revenue, Net— The Company sells TYMLOS to a limited number of wholesalers in the U.S (collectively, its "Customers"). These Customers subsequently resell the Company’s products to specialty pharmacy providers, as well as other retail pharmacies and certain medical centers or hospitals. In addition to distribution agreements with Customers, the Company enters into arrangements with health care providers and payors that provide for government mandated and/or privately negotiated rebates, chargebacks, and discounts with respect to the purchase of the Company’s products.
The Company recognizes revenue on product sales when the Customer obtains control of the Company's product, which occurs at a point in time (upon delivery). Product revenues are recorded net of applicable reserves for variable consideration, including discounts and allowances.

If taxes should be collected from Customers relating to product sales and remitted to governmental authorities, they will be excluded from revenue. The Company expenses incremental costs of obtaining a contract when incurred, if the expected amortization period of the asset that the Company would have recognized is one year or less. However, no such costs were incurred during the three and nine months ended September 30, 2017.
Reserves for Variable Consideration— Revenues from product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established. Components of variable consideration include trade discounts and allowances, product returns, provider chargebacks and discounts, government rebates, payor rebates, and other incentives, such as voluntary patient assistance, and other allowances that are offered within contracts between the Company and its Customers, payors, and other indirect customers relating to the Company’s sale of its products. These reserves, as detailed below, are based on the amounts earned, or to be claimed on the related sales, and are classified as reductions of accounts receivable (if the amount is payable to the Customer) or a current liability (if the amount is payable to a party other than a Customer). These estimates take into consideration a range of possible outcomes which are probability-weighted in accordance with the expected value method in Topic 606 for relevant factors such as current contractual and statutory requirements, specific known market events and trends, industry data, and forecasted customer buying and payment patterns. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the respective underlying contracts.
The amount of variable consideration which is included in the transaction price may be constrained, and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized under the contract will not occur in a future period. The Company’s analyses also contemplated application of the constraint in accordance with the guidance, under which it determined a material reversal of revenue would not occur in a future period for the estimates detailed below as of September 30, 2017 and, therefore, the transaction price was not reduced further during the three and nine months ended September 30, 2017. Actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results in the future vary from the Company’s estimates, the Company will adjust these estimates, which would affect net product revenue and earnings in the period such variances become known.
Trade Discounts and Allowances— The Company generally provides Customers with discounts which include incentive fees that are explicitly stated in the Company’s contracts and are recorded as a reduction of revenue in the period the related product revenue is recognized. In addition, the Company compensates (through trade discounts and allowances) its Customers for sales order management, data, and distribution services. However, the Company has determined such services received to date are not distinct from the Company’s sale of products to the Customer and, therefore, these payments have been recorded as a reduction of revenue within the statement of operations and comprehensive loss through September 30, 2017, as well as a reduction to trade receivables, net on the condensed consolidated balance sheets.
Product Returns— Consistent with industry practice, the Company generally offers Customers a limited right of return for product that has been purchased from the Company based on the product’s expiration date, which lapses upon shipment to a patient. The Company estimates the amount of its product sales that may be returned by its Customers and records this estimate as a reduction of revenue in the period the related product revenue is recognized, as well as reductions to trade receivables, net on the condensed consolidated balance sheets. The Company currently estimates product return liabilities using available industry data and its own sales information, including its visibility into the inventory remaining in the distribution channel. The Company has received an immaterial amount of returns to date and believes that returns of product in future periods will be minimal.
Provider Chargebacks and Discounts— Chargebacks for fees and discounts to providers represent the estimated obligations resulting from contractual commitments to sell products to qualified healthcare providers at prices lower than the list prices charged to Customers who directly purchase the product from the Company. Customers charge the Company for the difference between what they pay for the product and the ultimate selling price to the qualified healthcare providers. These reserves are established in the same period that the related revenue is recognized, resulting in a reduction of product revenue and trade receivables, net. Chargeback amounts are generally determined at the time of resale to the qualified healthcare provider by Customers, and the Company generally issues credits for such amounts within a few weeks of the Customer’s notification to the Company of the resale. Reserves for chargebacks consist of credits that the Company expects to issue for units that remain in the distribution channel inventories at each reporting period-end that the Company expects will be sold to qualified healthcare providers, and chargebacks that Customers have claimed, but for which the Company has not yet issued a credit.
Government Rebates— The Company is subject to discount obligations under state Medicaid programs and Medicare. These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included in accrued expenses and other current liabilities on the condensed consolidated balance sheets. For Medicare, the Company also estimates the number of patients in the prescription drug coverage gap for whom the Company will owe an additional liability under the Medicare Part D program. The Company’s liability for these rebates consists of invoices received for claims from prior quarters that have not been paid or for which an

invoice has not yet been received, estimates of claims for the current quarter, and estimated future claims that will be made for product that has been recognized as revenue, but which remains in the distribution channel inventories at the end of each reporting period.
Payor Rebates— The Company contracts with certain private payor organizations, primarily insurance companies and pharmacy benefit managers, for the payment of rebates with respect to utilization of its products. The Company estimates these rebates and records such estimates in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability.
Other Incentives— Other incentives which the Company offers include voluntary patient assistance programs, such as the Company's co-pay assistance program, which are intended to provide financial assistance to qualified commercially-insured patients with prescription drug co-payments required by payors. The calculation of the accrual for co-pay assistance is based on an estimate of claims and the cost per claim that the Company expects to receive associated with product that has been recognized as revenue, but remains in the distribution channel inventories at the end of each reporting period. The adjustments are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included as a component of accrued expenses and other current liabilities on the condensed consolidated balance sheets.
Collaboration Revenues— The Company enters into out-licensing agreements which are within the scope of Topic 606, under which it licenses certain rights to its product candidates to third parties. The terms of these arrangements typically include payment to the Company of one or more of the following: non-refundable, up-front license fees; development, regulatory, and commercial milestone payments; payments for manufacturing supply services the Company provides through its contract manufacturers; and royalties on net sales of licensed products. Each of these payments may result in license, collaboration, or other revenue, except revenue from royalties on net sales of licensed products, which would be classified as royalty revenue.
In determining the appropriate amount of revenue to be recognized as it fulfills its obligations under each of its agreements, the Company performs the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation. As part of the accounting for these arrangements, the Company must develop assumptions that require judgment to determine the stand-alone selling price for each performance obligation identified in the contract. The Company uses key assumptions to determine the stand-alone selling price, which may include forecasted revenues, development timelines, reimbursement rates for personnel costs, discount rates, and probabilities of technical and regulatory success.
Licenses of Intellectual PropertyIf the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenue from non-refundable, up-front fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. The Company will evaluate the measure of progress each reporting period and, if necessary, adjust the measure of performance and related revenue recognition.
Milestone PaymentsAt the inception of each arrangement that includes development milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the customer, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as, or when, the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company will re-evaluate the probability of achievement of such development milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect license, collaboration, other revenue, and earnings in the period of adjustment.
Manufacturing Supply ServicesArrangements that include a promise for future supply of drug substance or drug product for either clinical development or commercial supply, at the customer’s discretion, are generally considered as options. The Company assesses if these options provide a material right to the licensee and, if so, they are accounted for as separate performance obligations. If the Company is entitled to additional payments when the licensee exercises these options, any

additional payments are recorded in license, collaboration, or other revenue when the customer obtains control of the goods, which is upon delivery.
RoyaltiesFor arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all the royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized any royalty revenue resulting from its out-licensing arrangement.
Product Revenue Reserves and AllowancesChargebacks, discounts, fees, and returns are recorded as reductions of trade receivables, net on the condensed consolidated balance sheets. Government and other rebates are recoded as a component of accrued expenses and other current liabilities on the condensed consolidated balance sheets.
Inventory—The Company values its inventories at the lower of cost or estimated net realizable value. The Company determines the cost of its inventories, which includes amounts related to materials and manufacturing overhead, on a first-in, first-out basis. The Company performs an assessment of the recoverability of capitalized inventory during each reporting period, and it writes down any excess and obsolete inventories to their estimated realizable value in the period in which the impairment is first identified. Such impairment charges, should they occur, are recorded within cost of product revenues. The determination of whether inventory costs will be realizable requires estimates by management. If actual market conditions are less favorable than projected by management, additional write-downs of inventory may be required which would be recorded as a cost of product sales in the consolidated statements of operations and comprehensive loss.
The Company capitalizes inventory costs associated with the Company’s products after regulatory approval when, based on management’s judgment, future commercialization is considered probable and the future economic benefit is expected to be realized. Inventory acquired prior to receipt of marketing approval of a product candidate is expensed as research and development expense as incurred. Inventory that can be used in either the production of clinical or commercial product is expensed as research and development expense when selected for use in a clinical manufacturing campaign.
Shipping and handling costs for product shipments are recorded as incurred in cost of product revenues along with costs associated with manufacturing the product, and any inventory write-downs.
Intangible Assets—The Company maintains definite-lived intangible assets related to certain capitalized milestones. These assets are amortized over their remaining useful lives, which are estimated based on the shorter of the remaining patent life or the estimated useful life of the underlying product. Intangible assets are amortized using the economic consumption method if anticipated future revenues can be reasonably estimated. The straight-line method is used when future revenues cannot be reasonably estimated. 
The Company assesses its intangible assets for impairment if indicators are present or changes in circumstance suggest that impairment may exist. Events that could result in an impairment, or trigger an interim impairment assessment, include the receipt of additional clinical or nonclinical data regarding one of the Company’s drug candidates or a potentially competitive drug candidate, changes in the clinical development program for a drug candidate, or new information regarding potential sales for the drug. If impairment indicators are present or changes in circumstance suggest that impairment may exist, the Company performs a recoverability test by comparing the sum of the estimated undiscounted cash flows of each intangible asset to its carrying value on the condensed consolidated balance sheet. If the undiscounted cash flows used in the recoverability test are less than the carrying value, the Company would determine the fair value of the intangible asset and recognize an impairment loss if the carrying value of the intangible asset exceeds its fair value.
Convertible Note Payable— In accordance with accounting guidance for debt with conversion and other options, the Company separately accounted for the liability and equity components of the Company's 3% Convertible Senior Notes due by 2024 (the "Convertible Notes") by allocating the proceeds between the liability component and the embedded conversion option (the “Equity Component”) due to the Company’s ability to settle the Convertible Notes in cash, common stock or a combination of cash and common stock, at its option. The carrying amount of the liability components was calculated by measuring the fair value of a similar liability that does not have an associated convertible feature. The allocation was performed in a manner that reflected the Company’s non-convertible debt borrowing rate for similar debt. The Equity Component of the Convertible Notes was recognized as a debt discount and represents the difference between the proceeds from the issuance of the Convertible Notes and the fair value of the liability of the Convertible Notes on their respective dates of issuance. The excess of the principal amount of the liability component over its carrying amount (the “Debt Discount”) is amortized to interest expense using the effective interest method over seven years. The Equity Component is not remeasured as long as it continues to meet the conditions for equity classification. In connection with issuance of the Convertible Notes, the Company also incurred certain offering costs directly attributable to the offering. Such costs are deferred and amortized over the term of the debt to

interest expense using the effective interest method. A portion of the deferred financing costs incurred in connection with the Convertible Notes was deemed to relate to the Equity Component and was allocated to additional paid-in capital.
Accounting Standards Updates— In January 2016, the FASB issued ASU No. 2016-01, Financial Statements-Overall (Subtopic 825-10) (“ASU 2016-01”). ASU 2016-01 provides updated guidance on the recognition and measurement of financial assets and financial liabilities that will supersede most current guidance. ASU 2016-01 primarily affects the accounting for equity investments, financial liabilities under the fair value option, and the presentation and disclosure requirements for financial instruments. The amendments in ASU 2016-01 supersede the guidance to classify equity securities with readily determinable fair values into different categories and require equity securities to be measured at fair value with changes in the fair value recognized through net income. The amendments under ASU 2016-01 are effective, for public business entities, for periods beginning after December 15, 2017, including interim periods within those fiscal years. Early adoption is permitted. The Company does not expect the adoption of ASU 2016-01 to have a material impact on its results of operations, financial position or cash flows.
In February 2016, the FASB issued ASU No. 2016-02, Leases (“ASU 2016-02”). ASU 2016-02 supersedes the lease guidance under FASB ASC Topic 840, Leases, resulting in the creation of FASB ASC Topic 842, Leases. ASU 2016-02 requires a lessee to recognize in the statement of financial position a liability to make lease payments and a right-of-use asset representing its right to use the underlying asset for the lease term for both finance and operating leases. ASU 2016-02 is effective for fiscal years, and interim periods within those years, beginning after December 15, 2018. Early adoption is permitted. The Company is currently assessing the potential impact of adopting ASU 2016-02 on its financial statements and related disclosures.
In August 2016, the FASB issued ASU No. 2016-15, Classification of Certain Cash Receipts and Cash Payments (“ASU 2016-15”). ASU 2016-15 addresses eight specific cash flow issues with the objective of reducing the existing diversity in practice. ASU 2016-15 is effective for fiscal years, and interim periods within those years, beginning after December 15, 2017. Early adoption is permitted. The Company does not expect the adoption of ASU 2016-05 to have a material impact on its results of operations, financial position or cash flows.
In May 2017, the FASB issued ASU 2017-09, Compensation-Stock Compensation (Topic 718) ("ASU 2017-09") Scope of Modification Accounting. ASU 2017-09 provides clarification on when modification accounting should be used for changes to the terms or conditions of a share-based payment award. The amendments in ASU 2017-09 are effective for all entities for annual periods, and interim periods within those annual periods, beginning after December 15, 2017, with early adoption permitted, applied prospectively to an award modified on or after the adoption date. This ASU does not change the accounting for modifications but clarifies that modification accounting guidance should only be applied if there is a change to the value, vesting conditions, or award classification and would not be required if the changes are considered non-substantive. The Company is currently assessing the impact that adopting this new accounting standard will have on its consolidated financial statements.
3. Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consist of the following (in thousands):
 September 30,
2017
 December 31,
2016
Commercial costs$8,652
 $4,038
Research costs6,780
 9,632
Payroll and employee benefits12,967
 9,338
Interest1,195
 
Professional fees4,722
 3,494
Other current liabilities95
 95
Total accrued expenses and other current liabilities$34,411
 $26,597

4. Marketable Securities
Available-for-sale marketable securities and cash and cash equivalents as of September 30, 2017 and December 31, 2016 consist of the following (in thousands):

 September 30, 2017
 Amortized Cost Value 
Gross 
Unrealized 
Gains
 
Gross 
Unrealized 
Losses
 Fair Value
Cash and cash equivalents: 
  
  
  
Cash$110,853
 $
 $
 $110,853
Money market funds315,110
 
 
 315,110
Domestic corporate debt securities7,000
 
 
 7,000
Domestic corporate commercial paper13,975
 
 
 13,975
Total$446,938
 $
 $
 $446,938
        
Marketable securities: 
  
  
  
Domestic corporate debt securities$11,655
 $
 $
 $11,655
Domestic corporate commercial paper9,487
 2
 
 9,489
Total$21,142
 $2
 $
 $21,144
 December 31, 2016
 Amortized Cost Value 
Gross 
Unrealized 
Gains
 
Gross 
Unrealized 
Losses
 Fair Value
Cash and cash equivalents: 
  
  
  
Cash$77,443
 $
 $
 $77,443
Money market funds173,631
 
 
 173,631
Domestic corporate commercial paper5,487
 
 
 5,487
Domestic corporate debt securities2,006
 
 
 2,006
Total$258,567
 $
 $
 $258,567
        
Marketable securities: 
  
  
  
Domestic corporate debt securities$19,317
 $
 $(2) $19,315
Domestic corporate commercial paper31,852
 78
 
 31,930
Asset-backed securities22,639
 
 (4) 22,635
Total$73,808
 $78
 $(6) $73,880
There were no debt securities that had been in an unrealized loss position for more than 12 months as of September 30, 2017 or December 31, 2016, respectively. There were 3 debt securities in an unrealized loss position for less than 12 months at September 30, 2017 and there were 13 debt securities that had been in an unrealized loss position for less than 12 months at December 31, 2016. The aggregate unrealized loss on these securities as of September 30, 2017 and December 31, 2016 was less than $1 thousand and $6 thousand, respectively, and the fair value was $9.4 million and $35.7 million, respectively. The Company considered the decrease in market value for these securities to be primarily attributable to current economic conditions. As it was not more likely than not that the Company would be required to sell these securities before the recovery of their amortized cost basis, which may be at maturity, the Company did not consider these investments to be other-than-temporarily impaired as of September 30, 2017.
As of September 30, 2017, marketable securities consisted of investments that mature within one year.
5. Fair Value Measurements
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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 ninethree months ended September 30, 2017 and 2016, respectively.March 31, 2022 or 2021.
The following table summarizes the financial instruments measured at fair value on a recurring basis in the accompanying condensed consolidated balance sheets as of September 30, 2017March 31, 2022 and December 31, 20162021 (in thousands):
As of September 30, 2017 As of March 31, 2022
Level 1 Level 2 Level 3 Total Level 1Level 2Level 3Total
Assets 
  
  
  
Assets    
Cash and cash equivalents: 
  
  
  
Cash and cash equivalents:    
Cash$110,853
 $
 $
 $110,853
Cash$21,363 $— $— $21,363 
Money market funds (1)315,110
 
 
 315,110
Money market funds (1)50,252 — — 50,252 
Domestic corporate debt securities (2)
 7,000
 
 7,000
Domestic corporate commercial paper (2)
 13,975
 
 13,975
Total$425,963
 $20,975
 $
 $446,938
Total$71,615 $— $— $71,615 
Marketable Securities 
  
  
  
Domestic corporate debt securities (2)$
 $11,655
 $
 $11,655
Domestic corporate commercial paper (2)
 9,489
 
 9,489
Total$
 $21,144
 $
 $21,144
 
As of December 31, 2016 As of December 31, 2021
Level 1 Level 2 Level 3 Total Level 1Level 2Level 3Total
Assets 
  
  
  
Assets    
Cash and cash equivalents: 
  
  
  
Cash and cash equivalents:    
Cash$77,443
 $
 $
 $77,443
Cash$41,285 $— $— $41,285 
Money market funds (1)173,631
 
 
 173,631
Money market funds (1)70,248 — — 70,248 
Domestic corporate commercial paper (2)
 5,487
 
 5,487
Domestic corporate debt securities (2)
 2,006
 
 2,006
Total$251,074
 $7,493
 $
 $258,567
Total$111,533 $— $— $111,533 
Marketable Securities 
  
  
  
Domestic corporate debt securities (2)$
 $19,315
 $
 $19,315
Domestic corporate commercial paper (2)
 31,930
 
 31,930
Asset-backed securities (2)
 22,635
 
 22,635
Total$
 $73,880
 $
 $73,880
(1)Fair value is based upon quoted market prices.
(2)FairThe 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 based uponinfluenced by interest rates, the Company’s stock price and stock price volatility. The estimated fair value of the Convertible Notes as of March 31, 2022 was approximately $187.3 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 instrumentsliabilities in active markets, quoted prices for identical or similar instruments in marketsas well as inputs that are not active and model-based valuation techniquesobservable for which all significant assumptionsthe 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 March 31, 2022 was approximately $145.8 million.
As of March 31, 2022, the carrying amounts of the cash and cash equivalents, restricted cash, accounts receivable, prepaid expenses, other current assets, accounts payable, accrued expenses, and operating lease liabilities approximated their estimated fair values.
4. Inventory
Inventory consisted of the following as of March 31, 2022 and December 31, 2021 (in thousands):
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March 31,
2022
December 31,
2021
Raw materials$9,035 $7,159 
Work in process693 1,335 
Finished goods3,568 2,879 
Total inventories$13,296 $11,373 
Finished goods manufactured by the Company have a 36-month shelf life from date of manufacture.
5. Convertible Notes Payable
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 market or can be corroborated by observable market data for substantiallyoffering. In connection with the full termissuance of the assets. InputsConvertible 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 obtained from various sources, including market participants, dealerssenior unsecured obligations of the Company and brokers.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 included in Note 6, “Term Loan and Credit Facility.” 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:
6. License Agreements(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;
Ipsen(2)during the 5-business day period after any 5-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 March 31, 2022, none of the above circumstances had occurred and, as such, the Convertible Notes were not convertible.
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 5 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 September 2005,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 license agreement (the "License Agreement"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
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extinguishment of $0.3 million were included in selling, general and administrative expense for the three months ended March 31, 2021.
The outstanding balances of the Convertible Notes as of March 31, 2022 consisted of the following (in thousands):
2024 Convertible Notes
Liability
Principal$192,753 
Less: debt discount and issuance costs, net(2,067)
Net carrying amount$190,686 
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 March 31, 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 ended March 31, 2022 and 2021 (in thousands):
Three Months Ended March 31,
20222021
Contractual interest expense$1,446 $2,157 
Amortization of debt discount196 293 
Amortization of debt issuance costs11 16 
Total interest expense$1,653 $2,466 
Future minimum payments on the Company’s Convertible Notes as of March 31, 2022 are as follows (in thousands):
Years ended December 31,Future Minimum Payments
20222,891 
20235,783 
2024198,535 
Total minimum payments$207,209 
Less: interest(14,456)
Less: unamortized discount(2,067)
Less: current portion— 
Convertible notes payable$190,686 
6. Term Loan and Credit Facility
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 Financial Trust, in its capacity as amended,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 affiliateaggregate principal amount of Ipsen Pharma SAS ("Ipsen"$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 Company exclusively licensedBorrowers 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
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accounts receivable due from eligible direct and third-party payors, plus (ii) up to 40% of the Borrowers’ domestic eligible inventory, minus certain Ipsen compound technologyreserves; provided that the availability from eligible inventory may not exceed 20% of the borrowing base at any time. As of March 31, 2022 and related patents covering abaloparatideup to research, develop, manufacture, and commercialize certain compounds and related products

in all countries, except Japan (wherethe date of issuance of these condensed consolidated financial statements, the Company has an optionwas eligible to negotiateborrow $25.0 million of the Revolving Facility.
The Facilities have a co-promotion agreement for abaloparatide-SC)maturity date of June 1, 2024. The obligations under the Credit Agreements are guaranteed by the Borrowers and France (whereare guaranteed by certain future subsidiaries of the Company’s commercialization rights wereBorrowers, subject to certain co-marketingexceptions. The obligations under the Facilities are secured by substantially all of the assets of the Borrowers, and co-promotion rights exercisableare secured by Ipsen, providedsubstantially all assets of the future subsidiaries of the Borrowers that become borrowers or guarantors under the Facilities, subject to certain conditionsexceptions.
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.
On March 11, 2021, the Company received proceeds of $122.6 million under the Term Facility, 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 License Agreementthree months ended March 31, 2021. The outstanding balance of the Term Loan as of March 31, 2022 was (in thousands):
Term loan
Principal$150,000 
Less: debt issuance costs, net(1,527)
Net carrying amount$148,473 
The following table sets forth total interest expense recognized related to the Term Facility during the three months ended March 31, 2022 and 2021 (in thousands):
Three Months Ended March 31
20222021
Contractual interest expense$2,961 $1,037 
Amortization of debt discount208 49 
Total interest expense$3,169 $1,086 
Future minimum payments on the Term Facility as of March 31, 2022 are as follows (in thousands):
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Years ended December 31,Future Minimum Payments
20228,719 
202361,302 
2024102,260 
Total minimum payments$172,281 
Less: interest(22,281)
Less: unamortized issuance costs(1,527)
Less: current portion— 
Term loan$148,473 
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7. 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):

Three Months Ended
March 31,
 20222021
Numerator:  
Net loss$(18,276)$(15,749)
Denominator:  
Weighted-average number of common shares used in loss per share - basic and diluted47,441,821 46,981,016 
Loss per share - basic and diluted$(0.39)$(0.34)
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 months ended March 31, 2022 and 2021, respectively, all of the Company’s options to purchase common stock, restricted stock units outstanding, and performance options were met). assumed to be anti-dilutive as earnings attributable to common stockholders was in a loss position.
Three Months Ended March 31,
 20222021
Options to purchase common stock5,822,796 6,203,490 
Restricted stock units1,765,418 460,907 
Performance units960,000 — 
Performance options1,035,000 1,035,000 
The Company believes that Ipsen's co-marketinghas 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 March 31, 2022, they are not participating securities and co-promotion rightsthey 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 month periods ended March 31, 2022 and 2021, respectively. The Company uses the if-converted method for the Convertible Notes.
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8. 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 France have permanently expired. Ipsen also granted the Company an exclusive right and license under the Ipsen compound technology and related patents to make, and have made, compounds or products in Japan. Ipsen further granted the Company an exclusive right and license under certain Ipsen formulation technology and related patents solely for purposes of enabling the Company to develop, manufacture, and commercialize compounds and products covered by the compound technology license in all countries, except Japan and France (as discussed above).
In consideration for these rights, the Company made nonrefundable, non-creditable payments in the aggregate of $13.0 million to Ipsen, including payment in recognition of certain milestones having been achieved through September 30,May 2017. The License Agreement providesfollowing table summarizes activity in each of the product revenue allowance and reserve categories for further payments upon the achievement of certain future regulatorythree months ended March 31, 2022 and commercial milestones. Total additional milestone payments that could be payable under the agreement is €24.0 million (approximately $28.4 million). In connection with the FDA's approval of TYMLOS in April 2017, the Company paid Ipsen a milestone of €8.0 million (approximately $8.7 million) under the License Agreement, which the Company2021 (in thousands):
Chargebacks, Discounts, and FeesGovernment and other rebatesReturnsTotal
Ending balance at December 31, 2020$1,891 $14,644 $2,572 $19,107 
Provision related to sales in the current year4,383 25,681 118 30,182 
Adjustments related to prior period sales(90)(534)(2,249)(2,873)
Credits and payments made(5,080)(18,984)(127)(24,191)
Ending balance at March 31, 20211,104 20,807 314 22,225 
Ending balance at December 31, 2021$2,061 $24,604 $224 $26,889 
Provision related to sales in the current year4,453 30,087 119 34,659 
Adjustments related to prior period sales— 239 — 239 
Credits and payments made(4,690)(28,168)(109)(32,967)
Ending balance at March 31, 2022$1,824 $26,762 $234 $28,820 
Chargebacks, discounts, fees, and returns are recorded as an intangible asset withinreductions of accounts receivables, net on the condensed consolidated balance sheetsheets. Government and will amortize over the remaining patent life or the estimated useful lifeother rebates are recorded as a component of the underlying product. The agreement also provides that the Company will pay to Ipsen a fixed five percent royalty based on net sales of the product by the Company or its sublicensees on a country-by-country basis until the later of the last to expire of the licensed patents or for a period of 10 years after the first commercial sale in such country. The royalty expense was immaterial for the threeaccrued expenses and nine months ended September 30, 2017. The date of the last to expire of the abaloparatide patents licensed from or co-owned with Ipsen, barring any extension thereof, is expected to be March 26, 2028.
If the Company sublicenses abaloparatide to a third party, then the agreement provides that the Company would pay Ipsen a percentage of certain payments received from such sublicensee (in lieu of milestone payments not achieved at the time of such sublicense). The applicable percentage is in the low double-digit range. In addition, if the Company or its sublicensees commercialize a product that includes a compound discovered by it based on or derived from confidential Ipsen know-how, then the agreement provides that the Company would pay to Ipsen a fixed low single digit royalty on net sales of such product on a country-by-country basis until the later of the last to expire of licensed patents that cover such product or for a period of 10 years after the first commercial sale of such product in such country.
The License Agreement expires on a country-by-country basisother current liabilities on the later of (1) the date the last remaining valid claim in the licensed patents expires in that country, or (2) a period of 10 years after the first commercial sale of the licensed products in such country, unless it is sooner terminated in accordance with its terms.condensed consolidated balance sheets.
9. License Revenue and Reimbursable Expenses
General
The Company is currently in arbitration proceedingshas generated revenue from contracts with Ipsen in connection with the License Agreement. See "Legal Proceedings"customers, which include upfront payments for more information.
Eisai Co. Ltd.
In June 2006, the Company entered into a license agreement (the “Eisai Agreement”), with Eisai Co. Ltd. (“Eisai”). Under the Eisai Agreement, Eisai granted to the Company an exclusive right and license to research, develop, manufacture and commercialize elacestrant (RAD1901) and related products from Eisai in all countries, except Japan. In consideration for the rights to elacestrant, the Company paid Eisai an initial license fee of $0.5 million, which was expensed during 2006. In March 2015, the Company entered into an amendment to the Eisai Agreement (the “Eisai Amendment”) in which Eisai granted to the Company the exclusive right and license to research, develop, manufacture and commercialize elacestrant in Japan. In consideration for the rights to elacestrant in Japan, the Company paid Eisai an initial license fee of $0.4 million upon execution of the Eisai Amendment, which was recognized as research and development expense in 2015. The Eisai Amendment, as amended, also provides for additional payments of up to $22.3 million, payable upon the achievement of certain clinical and regulatory milestones.
Under the Eisai Agreement, as amended, should a product covered by the licensed technology be commercialized, the Company will be obligated to pay to Eisai royalties in a variable mid-single digit range based on net sales of the product on a country-by-country basis. The royalty rate will be reduced, on a country-by-country basis, at such time as the last remaining valid claim in the licensed patents expires, lapses, or is invalidated and the product is not covered by data protection clauses. In addition, the royalty rate will be reduced, on a country-by-country basis, if, in addition to the conditions specified in the previous sentence, sales of lawful generic versions of such product account for more than a specified minimum percentage of the total sales of all products that contain the licensed compound during a calendar quarter. The latest licensed patent is expected to expire, barring any extension thereof, on August 18, 2026.
The Eisai Agreement, as amended, also grants the Company the right to grant sublicenses with prior written approval from Eisai. If the Company sublicenses the licensed technology to a third party, the Company will be obligated to pay Eisai, in

addition to the milestones referenced above, a fixed low double-digit percentage of certain fees received from such sublicensee and royalties in the low single digit range based on net sales of the sublicensee. The Eisai Agreement expires on a country-by-country basis on the later of (1) the date the last remaining valid claim in the licensed patents expires, lapses or is invalidated in that country, the product is not covered by data protection clauses, and the sales of lawful generic versions of the product account for more than a specified percentage of the total sales of all pharmaceutical products containing the licensed compound in that country; or (2) a period of 10 years after the first commercial sale of the licensed products in such country, unless it is sooner terminated.licenses.
Teijin Limited
In July 2017, the Company entered into a License and Development Agreement (the “Teijin Agreement”) with Teijin Limited (“Teijin”) for abaloparatide-SCabaloparatide 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, and (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.Japan, and (vi) a right to request that the Company arrange for Teijin to directly enter into commercial supply agreements with the Company’s existing contract manufacturers on the same pricing terms and on substantially similar commercial terms to those set forth in the Company’s existing agreements with such contract manufacturers. In consideration for these rights, the Company received an upfront payment of $10.0 million, and may receive further payments upon the achievement of certain regulatory and sales milestones, as well as a fixed low double-digit royalty based on net sales of abaloparatide-SC in Japan during the royalty term, as defined below. In addition, the Company has an option to negotiate a co-promotion agreement with Teijin for abaloparatide-SC in Japan upon commercialization.

Pursuant to the Teijin Agreement, the parties may further collaborate on new indications for abaloparatide-SC, and theabaloparatide-SC. The Company also maintains full global rights to its development program for abaloparatide-TD,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.
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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 recently completed 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. The Company received this amount in October 2017. 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 future regulatory milestone, which represents variable consideration that was evaluated under the most likely amount method, haswas not been included in the transaction price, because the amount was fully constrained as of September 30, 2017.constrained. As part of its evaluation of the constraint, the Company considered numerous factors, including that receipt of the milestone iswas outside the control of the Company. Separately, anyAny 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.
DuringIn 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 and nine months ended September 30, 2017,March 31, 2021.
Berlin-Chemie
In July 2020, the Company recognized $10.0 million ofentered into to a license revenue, as it had satisfied its promisesagreement (“License Agreement”) with Berlin-Chemie under which the performance obligation for the commercializationCompany granted Berlin-Chemie an exclusive license to develop and manufacturing licenses, including the right of reference to certain regulatory information, by transferring them at a point in time during the quarter. As of September 30, 2017, the upfront payment was recorded on the Company’s condensed consolidated balance sheet within accounts receivable, net, as payment was not received until October 2017.commercialize products containing elacestrant (RAD1901) worldwide.
7. Research Agreements
Abaloparatide-SC Phase 3 Extension Study
The Company contracted with Nordic Bioscience Clinical Development VII A/S ("Nordic"and Berlin-Chemie simultaneously entered into a Transition Services Agreement (the “TSA”), pursuant to conduct awhich the Company has agreed to perform certain services for Berlin-Chemie related to the EMERALD Phase 3 clinical trialmonotherapy study until the earlier of abaloparatide-SC (the "Phase 3 Clinical Trial"). The Company also contracted with Nordic to perform an extension study to evaluate six months of standard-of-care osteoporosis management following the completion of the Phase 3 Clinical Trialcontemplated services or the filing with the FDA of a New Drug Application (the "Extension Study"“NDA”), and, upon completion of this initial six months, an additional period of 18 months of standard-of-care osteoporosis management (the “Second Extension”).
In April 2015, for elacestrant. Pursuant to the TSA, Berlin-Chemie agreed to reimburse the Company contracted with Nordic to perform additional services, including additional monitoring of patients enrolledfor all out-of-pocket and full-time employee costs in the Second Extension. Payments in cash made to Nordic for these additional services were denominated in euros and totaled up to approximately €4.1 million (approximately $4.3 million).
Payments in cash made to Nordic forperforming the services, related to the Extension Study and Second Extension were denominated in both euros and U.S. dollars and totaled up to €11.9 million (approximately $12.5 million) and $1.1 million, respectively. Asfor total estimated reimbursements of December 31, 2016, the last patient's final visit in the Second Extension had occurred and all obligations due to Nordic in relation to the Extension Study had been paid.
8. Stock-Based Compensation
Stock Options

A summary of stock option activity during the nine months ended September 30, 2017 is as follows (in thousands, except for per share amounts):
 Shares 
Weighted-
Average
Exercise
Price (in
dollars per
share)
 
Weighted-
Average
Contractual
Life (in
years)
 
Aggregate
Intrinsic
Value
Options outstanding at December 31, 20166,374
 $31.60
    
Granted1,977
 43.54
    
Exercised(1,301) 12.43
    
Cancelled(802) 40.01
    
Expired(15) 65.62
    
Options outstanding at September 30, 20176,233
 $38.23
 7.90 $41,269
Options exercisable at September 30, 20172,798
 $32.85
 6.77 $32,626
The weighted-average grant-date fair value per share of options granted during the three and nine months ended September 30, 2017 was $23.00 and $23.84, respectively. As of September 30, 2017, there was approximately $65.4 million of total unrecognized compensation expense related to unvested stock options, which is expected to be recognized over a weighted-average period of approximately 2.7 years.
Restricted Stock Units
$114.6 million. The Company awards restricted stock units ("RSUs")will continue to employees under its 2011 Equity Incentive Plan. Each RSU entitles the holder to receive one shareincur research and development expenses in support of the Company's common stock when the RSU vests. The RSUs vest in four substantially equal installments on each of the first four anniversaries of the vesting commencement date, subject to the employee's continued employment with, or service to, the Company on such vesting date. Compensation expense is recognized on a straight-line basis. In February 2017, the Company awarded 84,950 restricted stock units ("RSUs") to employees at an average grant date fair value of $45.65 per RSU.
A summary of RSU activity during the nine months ended September 30, 2017 is as follows (in thousands, except for per share amounts):
 RSUs 
Weighted-
Average
Grant Date
Fair Value 
(in dollars 
per share)
RSUs Outstanding at December 31, 201657
 $33.03
Granted85
 45.65
Vested(14) 33.03
Forfeited(18) 40.72
RSUs Outstanding at September 30, 2017110
 $41.59
As of September 30, 2017, there was approximately $3.8 million of total unrecognized compensation expense related to unvested RSUs, which is expected to be recognized over a weighted-average period of approximately 3.2 years.
Employee Stock Purchase Plan
In September 2016, the Company initiated the first offering periodscale up costs under the Company's 2016 Employee Stock Purchase Plan (the “ESPP”), pursuant to which eligible employees may purchase shares of the Company’s common stock on the last day of each predetermined six-month offering period at 85% of the lower of the fair market value per share at the beginning or end of the applicable offering period. The offering periods run from March 1 through August 31 and from September 1 through February 28 (or February 29, in a leap year) of each year.TSA.
As of September 30, 2017, the Company had recorded a liability of $0.4 million related to its ESPP obligations. In accordance with the terms of our employee stock purchase plan, the Company recorded stock-based compensation expense of $0.3 million and $0.8 million for the three and nine-month periods ended September 30, 2017, respectively.

9. Income Taxes
The Company did not record a federal or state income tax provision or benefit for the nine months ended September 30, 2017 and 2016 due to the expected loss before income taxes to be incurred for the years ended December 31, 2017 and 2016, as well as the Company’s continued maintenance of a full valuation allowance against its net deferred tax assets.
In December 2016, the Company migrated certain of its intellectual property to a foreign holding company operating in Bermuda. During 2017, the Company implemented additional steps relating to this internal strategy including executing transfer-pricing and cost share arrangements.
10. Net Loss Per Share
Basic and diluted net loss per share is calculated as follows (in thousands, except share and per share amounts):
 Three Months Ended
September 30,
 Nine Months Ended
September 30,
 2017 2016 2017 2016
Numerator: 
  
    
Net loss$(57,843) $(46,186) $(183,220) $(130,084)
        
Denominator: 
  
  
  
Weighted-average number of common shares used in loss per share - basic and diluted43,999,451
 43,092,921
 43,535,874
 43,049,734
Loss per share - basic and diluted$(1.31) $(1.07) $(4.21) $(3.02)
The following potentially dilutive securities, prior to the use of the treasury stock method, have been excluded from the computation of diluted weighted-average shares outstanding, as they would be anti-dilutive. For the three and nine months ended September 30, 2017 and 2016, all the Company’s options to purchase common stock, warrants, and restricted stock units outstanding were assumed to be anti-dilutive as earnings attributable to common stockholders was in a loss position.
  Three and Nine Months Ended September 30,
  2017 2016
Options to purchase common stock 6,233,398
 6,274,181
Warrants 605,415
 631,587
Restricted stock units 108,940
 56,250
Pursuant to the terms of the Convertible Notes,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
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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 referenced abovea 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 Note 2, Basisarrangement inception, should be combined with the know-how and regulatory filings as they are not capable of Presentationbeing distinct (the “License”). The Company also concluded that the license rights, know-how, and Significant Accounting Policies,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 a choiceallocated $27.4 million to settle the conversion obligationLicense and $2.6 million to the inventory. The Company concluded that the reimbursements for the Convertible Notesresearch and development transition services and participation in cash, shares or any combinationthe joint steering committees was commensurate with the standalone selling prices of the two. Asservices, and as such, will be attributed to those services. The reimbursements for these services are recorded as a reduction of the Convertible Notesrelated research and development expenses as the expenses are not participating securities, theyincurred.
Under the Berlin-Chemie agreements, the Company is eligible to receive various development and regulatory, and sales milestones. There is uncertainty that the 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 have an impactoccur. 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 months ended March 31, 2022 and 2021, the Company recorded $9.1 million and $14.3 million, respectively, as reductions of research and development expenses for reimbursement of transition services performed under the TSA. As of March 31, 2022 and December 31, 2021, we had receivable balances of $14.1 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 calculation of basic earnings or loss per share. Based on the Company's net loss position, there is no impact on the calculation of dilutive loss per share during the three and nine month periods ended September 30, 2017, respectively.condensed consolidated balance sheet.
11.10. Commitments and Contingencies
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Litigation- The
From time to time, the Company may bebecome subject to legal proceedings and claims which arise in the ordinary course of its business. In the Company's opinion, the ultimate resolution of these matters is not expected to have a material effect on its consolidated financial statements. The Company records a liability in its 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.
In November 2016,As of March 31, 2022, the Company received notice that in October 2016, Ipsen had initiated arbitration proceedings againstwas not party to any significant litigation.
Kindeva
The Company is a party to a Scale-Up and Commercial Supply Agreement (the “Supply Agreement”) with Kindeva, as successor to 3M Company and 3M Innovative Properties Company (collectively with 3M Company, “3M”), pursuant to which Kindeva has agreed to exclusively manufacture Phase 3 and global commercial supplies of an abaloparatide-coated transdermal system (“abaloparatide-TD”). Under the Supply Agreement, Kindeva will manufacture 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 manufacture commercial supplies of abaloparatide-TD at unit prices that decrease with an increase in the International Chamber of Commerce’s International Court of Arbitration. Ipsen’s Request for Arbitration alleged thatquantity the Company breached various provisionsorders. The Company would pay 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 is responsible for providing, at its expense, supplies of abaloparatide drug substance to be used in manufacturing abaloparatide-TD. During the term of the LicenseSupply Agreement, concerning abaloparatide, including regarding Ipsen's rightKindeva and the Company have agreed to co-promote abaloparatide in France and a license from the Companywork exclusively with each other with respect to Japan. Ipsen is seekingthe delivery of abaloparatide, parathyroid hormone (“PTH”), and/or PTH related proteins via active transdermal, intradermal, or microneedle technology.

declaratory relief, compliance with the License Agreement, damages, costs and fees as a resultThe initial term of the purported breaches,Supply Agreement began on its effective date, February 27, 2018 and has alleged thatwill continue for five years after the monetary valuefirst commercial sale of these claimsabaloparatide-TD. The Supply Agreement then automatically renews for successive three-year terms, unless earlier terminated pursuant to its terms or upon either party’s notice of termination to the other 24 months prior to the end of the then-current term. The Supply Agreement may be terminated by either party upon an uncured material breach of its terms by the other party, or due to the other party’s bankruptcy, insolvency, or dissolution. The Company may terminate the Supply Agreement upon the occurrence of certain events, including for certain clinical, technical, or commercial reasons impacting abaloparatide-TD, if it is approximately €50 million.
In January 2017,unable to obtain U.S. regulatory approval for abaloparatide-TD within a certain time period, or if it ceases development or commercialization of abaloparatide-TD. Kindeva may terminate the Supply Agreement upon the occurrence of certain events, including if there are certain safety issues related to abaloparatide-TD, if the Company submitted an Answer denying Ipsen’s claims and alleging counterclaims against Ipsenis unable to obtain U.S. regulatory approval for breachabaloparatide-TD within a certain time period, or if the Company fails to order abaloparatide-TD for a certain period of time after commercial launch of the License Agreementabaloparatide-TD in the U.S. Upon certain events of termination, Kindeva is required to transfer the manufacturing processes for abaloparatide-TD to the Company or a mutually agreeable third party and other declaratory judgment.continue supplying abaloparatide-TD for a period of time pursuant to the Company’s projected supply requirements. The Company asserted, among other things, that Ipsen's claimed rights to co-promote abaloparatidehas paid 3M and Kindeva approximately $63.0 million, in France and to a license from the Companyaggregate, through March 31, 2022 with respect to Japan have permanently expired,performance under the Supply Agreement. In addition, there are cancellable purchase commitments in place to fund certain facility build out and that Ipsen has breached the License Agreement by, among other things, allowing certain patents to expire and by purporting to license to a third party certain manufacturing and other rights that the Company contends Ipsen exclusively licensed to the Company. The Company is seeking dismissalfuture purchases of Ipsen’s claims, as well as declaratory relief, compliance with the License Agreement, and other damages, costs and fees to be determined by the Arbitral Tribunal.capital equipment.
In February 2017, Ipsen submitted a Reply denying the Company's counterclaims and alleging that the Company is precluded from asserting them. Following a preliminary hearing before the Arbitral Tribunal to determine certain jurisdictional and contractual defenses asserted by Ipsen in its Reply, on July 17, 2017, the Arbitral Tribunal issued a decision finding it has jurisdiction to decide the Company's counterclaims and that the Company's counterclaims are not contractually barred.
On July 31, 2017, Ipsen submitted its Statement of Claim to the Arbitral Tribunal and on September 14, 2017, Radius submitted its Statement of Defense and Counterclaims. Subsequently, on October 20, 2017, Ipsen submitted its Reply and Statement of Defense to Radius’s Counterclaims to the Arbitral Tribunal. The arbitration proceeding is continuing and, following additional briefing, a hearing on the merits is anticipated to be held in December 2017.  Given that this matter is at a preliminary stage, the Company cannot predict or assess the likely outcome of these proceedings.
Manufacturing Agreements - In June 2016,2009, the Company entered into a supplyDevelopment and Clinical Supplies Agreement with 3M, as amended (the “Development Agreement”), under which abaloparatide-TD development activities occur and 3M has manufactured phase 1 and 2 clinical trial supplies on an exclusive basis. The initial term of the Development Agreement remained in effect until June 2019, after which it automatically renews for successive one-year terms, unless earlier terminated, until the earliest of (i) the expiration or termination of the Supply Agreement, (ii) the mutual written agreement of the parties, or (iii) prior written notice by either party to the other party at least ninety days prior to the end of the then-current term of the Development Agreement that such party declines to extend the term. Either party may terminate the agreement in the event of an uncured material breach by the other party. The Company pays 3M for services delivered pursuant to the agreement on a fee-for-service or a fee-for-deliverable basis as specified in the agreement. The Company has paid 3M and Kindeva approximately $31.8 million, in the aggregate, through March 31, 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 (the “Device”) customized for subcutaneous injection of abaloparatide, the active pharmaceutical ingredient (“API”) for TYMLOS. The Company has agreed to purchase a minimum number of Devicesdevices at prices per Devicedevice that decrease with an increase in quantity supplied. In addition, the Company agreed to makehas made milestone payments for Ypsomed’s capital developments regardingin connection with the initiation of the commercial supply of the Device
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device and to pay a one-time capacity fee. All costs and payments under the agreement are delineated in Swiss Francs. The agreement hashad an initial term of three years, from the earlier of the date of delivery of the first commercial Devices for regulatory approval andwhich 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 until terminated. 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 $2.1 million).

The Company agreedis also a party to purchase the Device subject to certain minimum annual quantity requirements under the agreement. During the initial term of the agreement, the Company estimates that it will be obligated to make total minimum payments to Ypsomed of approximately CHF 3.9 million ($4.0 million) in the aggregate, including the milestone payments and one-time capacity fee.
In June 2016, the Company entered into a commercial supply agreementCommercial Supply Agreement with Vetter Pharma International GmbH (“Vetter”), as amended, pursuant to which Vetter has agreed to formulate the finished TYMLOSabaloparatide-SC drug product containing abaloparatide, the active pharmaceutical ingredient (“API”) of TYMLOS,API, to fill cartridges with the drug product, to assemble the pen delivery device, and to package and label 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-unitper unit price dependent upon the number of pens loaded with cartridges that are labeled and packaged. These prices are subject to an annual price adjustment. The agreement has an initial term of five years, which beganthe agreement automatically renewed on January 1, 2016, after which, it2021 for an additional two-year term and will automatically renewsrenew for additional two-year terms thereafter, unless either party provides notice of non-renewalnotifies the other party two years before the end of the then current term. There are no minimum purchase requirements under the terms of this contract.then-current term that it does not intend to renew.
In July 2016, the
The Company entered intois also a manufacturing services agreementparty to a Manufacturing Services Agreement with Polypeptide Laboratories Holding AB ("PPL"(“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 TYMLOS.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 agreedrequired to purchase a minimum number of batches annually.annually, equal to €2.9 million (approximately $3.1 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
12. Inventory
Inventory consistsIn 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 following at September 30, 2017 (in thousands):

  September 30,
2017
 December 31,
2016
Raw materials $2,724
 $
Work in process 273
 
Finished goods 77
 
Total inventories $3,074
 $
Inventory acquired prioragreement, the Company may be obligated to receiptmake additional payments of up to $60.0 million in future periods, which would become due and payable only upon the marketing approval for TYMLOS, totaling approximately $1.6achievement of certain development milestones. In addition, the Company may be obligated to pay up to $30.0 million was expensed as researchin sales milestones contingent upon the realization of sales revenues and development expense as incurred. Thesublicense revenue. As of March 31, 2022, the Company began to capitalize the costs associated with the productionrecognized a liability of TYMLOS upon receipt of FDA approval on April 28, 2017.
13. Product Revenue Reserves and Allowances
To date, the Company’s only source of product revenue has been from the U.S. sales of TYMLOS,$2.5 million, which it began shipping to Customers in May 2017. The following table summarizes activity in each of the product revenue allowance and reserve categories for the nine months ended September 30, 2017 (in thousands):
 
Chargebacks, Discounts, and Fees

 
Government and other rebates

 Returns Total
Beginning balance at December 31, 2016$
 $
 $
 $
Provision related to sales in the current year, net of credits and payments688
 459
 296
 $1,443
Ending balance at September 30, 2017$688
 $459
 $296
 $1,443
Chargebacks, discounts, fees, and returns areis recorded as reductions of trade receivables, net on the condensed consolidated balance sheets. Government and other rebates are recoded as a component of accrued expenses and other current liabilities onwithin the condensed consolidated balance sheets. Credits and paymentssheet for certain development milestones that were deemed probable of achievement.
11. Income Taxes
The Company did not record a federal or state income tax provision or benefit for each of the ninethree months ended September 30, 2017 are not significant.
14. Intangible Assets
The following table presents intangible assets as of September 30, 2017 (in thousands):
 September 30,
2017
 Estimated useful life
Acquired and in-licensed rights$8,712
 11 Years
Less: accumulated amortization(332)  
  Total intangible asset, net$8,380
  
The increase in acquiredMarch 31, 2022 and in-licensed rights as of September 30, 2017 was2021 due to the milestone of €8.0 million (approximately $8.7 million) paidexpected loss before income taxes to Ipsen, which was triggered by the FDA approval of TYMLOS on April 28, 2017.
The Company recorded approximately $0.2 million and $0.3 million in amortization expense related to intangible assets, using the straight-line methodology, during the three and nine months ended September 30, 2017. Estimated future amortization expense for intangible assets as of September 30, 2017 is approximately $0.2 millionbe incurred for the remainder of 2017,years ended December 31, 2022 and approximately $0.8 million per year thereafter.
15. Convertible Notes Payable
On August 14, 2017, in a registered underwritten public offering, the Company issued $300 million aggregate principal amount of the Convertible Notes. In addition, on September 12, 2017, the Company issued an additional $5.0 million principal amount of Convertible Notes pursuant to the exercise of an over-allotment option granted to the underwriters in the offering. In accordance with accounting guidance for debt with conversion and other options, the Company separately accounted for the Liability and Equity Components of the Convertible Notes by allocating the proceeds between the Liability Component and the Equity Component, due to2021, as well as the Company’s ability to settle the Convertible Notes in cash, common stock or a combination of cash and common stock, at its option. In connection with the issuance of the Convertible Notes, the Company incurred

approximately $9.4 million of debt issuance costs, which primarily consisted of underwriting, legal and other professional fees, and allocated these costs to the Liability and Equity Components based on the allocation of the proceeds. Of the total $9.4 million of debt issuance costs, $4.3 million was allocated to the Equity Component and recorded as a reduction to additional paid-in capital and $5.1 million was allocated to the liability component and is now recorded as a reduction of the Convertible Notes in the Company’s condensed consolidated balance sheet. The portion allocated to the liability component is amortized to interest expense using the effective interest method over seven years.
The Convertible Notes are senior unsecured obligations of the Company and bear interest at a rate of 3.00% per annum, payable semi-annually in arrears on March 1 and September 1, beginning on March 1, 2018. Upon conversion, the Convertible Notes will be convertible into cash, shares of the Company’s common stock or a combination of cash and shares of the Company’s common stock, at the Company’s election. Prior to December 31, 2017, the Convertible Notes were not convertible except in connection with a make whole fundamental change, as defined in the respective indentures.The Convertible Notes will be subject to redemption at our option, on or after September 1, 2021, in whole or in part, if the conditions described below are satisfied. The Convertible Notes will mature on September 1, 2024, unless earlier converted, redeemed or repurchased in accordance with their terms. Subject to satisfaction of certain conditions and during the periods described below, the Convertible Notes may be converted at an initial conversion rate of 20.4891 shares of common stock per $1,000 principal amount of the Convertible Notes (equivalent to an initial conversion price of approximately $48.81 per share of common stock).
Holders of the Convertible Notes may convert all or any portion of their notes, in multiples of $1,000 principal amount, at their option at any time prior to the close of business on the business day immediately preceding June 1, 2024 only under the following circumstances:
(1)during any calendar quarter commencing after the calendar quarter ending on December 31, 2017 (and only during such calendar quarter), if the last reported sale price of the Company's common stock for at least 20 trading days (whether consecutive or not) during a period of 30 consecutive trading days ending on the last trading day of the immediately preceding calendar quarter is greater than or equal to 130% of the conversion price on each applicable trading day;
(2)during the five-business day period after any five-consecutive trading day period (the “measurement period”) in which the "trading price" per $1,000 principal amount of the Convertible Notes for each trading day of the measurement period was less than 98% of the product of the last reported sale price of the Company’s common stock and the conversion rate on each such trading day;
(3)if the Company calls the Convertible Notes for redemption, until the close of business on the business day immediately preceding the redemption date; or
(4)upon the occurrence of specified corporate events.
Prior to September 1, 2021, the Company may not redeem the Convertible Notes. On or after September 1, 2021, the Company may redeem for cash all or part of the Convertible Notes if the last reported sale price of the Company’s common stock equals or exceeds 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30-consecutive trading day period ending within five trading days prior to the date on which the Company provides notice of the redemption. The redemption price will be the principal amount of the Convertible Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date. In addition, calling any Convertible Note for redemption will constitute a make-whole fundamental change with respect to that Convertible Note, in which case the conversion rate applicable to the conversion of that Convertible Note, if it is converted in connection with the redemption, will be increased in certain circumstances.
In accordance with accounting guidance for debt with conversion and other options, the Company separately accounted for the liability and equity components of the Convertible Notes by allocating the proceeds between the liability component and the embedded conversion option (the “Equity Component”) due to the Company's ability to settle the Convertible Notes in cash, common stock or a combination of cash and common stock, at its option. The carrying amount of the Liability Component of $166.3 million was calculated by measuring the fair valuecontinued maintenance of a similar liability that does not have an associated convertible feature. The allocation was performed in a manner that reflected the Company's non-convertible debt borrowing rate for similar debt. The Equity Component of the Convertible Notes of $138.7 million was recognized as a debt discount and represents the difference between the proceeds from the issuance of the Convertible Notes of $305.0 million and the fair value of the liability of the Convertible Notes of approximately $305.0 million on their respective dates of issuance. The excess of the principal amount of the liability component overfull valuation allowance against its carrying amount (the “Debt Discount”) is amortized to interest expense using the effective interest method over seven years. The Equity Component is not remeasured as long as it continues to meet the conditions for equity classification. In connection with issuance of the Convertible Notes, the Company also incurred certainnet deferred tax assets.

offering costs directly attributable to the offering. Such costs are deferred and amortized over the term of the debt to interest expense using the effective interest method. A portion of the deferred financing costs incurred in connection with the Convertible Notes was deemed to relate to the Equity Component and was allocated to additional paid-in capital.
The outstanding balances of the Convertible Notes as of September 30, 2017 consisted of the following (in thousands):
 2024 Convertible Notes
Liability component: 
Principal$305,000
Less: debt discount and issuance costs, net(142,241)
Net carrying amount$162,759
  
Equity component:$134,450
The Company determined the expected life of the Convertible Notes was equal to its seven year term. The effective interest rate on the Liability Components of the Convertible Notes for the period from the date of issuance through September 30, 2017 was 12.91%. As of September 30, 2017, the "if-converted value" did not exceed the remaining principal amount of the Convertible Notes. The fair values of the 3% Convertible Senior Notes due September 1, 2024 are based on data from readily available pricing sources which utilize market observable inputs and other characteristics for similar types of instruments, and, therefore, these convertible senior notes are classified within Level 2 in the fair value hierarchy. The fair value of the Convertible Notes, which differs from their carrying value, is influenced by interest rates, the Company’s stock price and stock price volatility. The estimated fair value of the Convertible Notes as of September 30, 2017 was approximately $308.5 million.
The following table sets forth total interest expense recognized related to the Convertible Notes during the three and nine months ended September 30, 2017 and 2016 (in thousands):
 Three and Nine Months Ended
September 30,
 2017 2016
Contractual interest expense$1,195
 $
Amortization of debt discount1,568
 
Total interest expense$2,763
 $
Future minimum payments on our long-term debt as of September 30, 2017 were as follows (in thousands):
Years ended December 31,Future Minimum Payments
2017$
20189,582
20199,150
20209,150
20219,150
2022 and Thereafter332,450
Total minimum payments$369,482
Less: interest(64,482)
Less: unamortized discount(142,241)
Less: current portion
Long Term Debt$162,759
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
Cautionary Statement

This Quarterly Report on Form 10-Q, including in the sections titled “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and including the information incorporated by reference herein, contains, in addition to historical information, forward-looking statements. We may, in some cases, use words such as “project,” “believe,” “anticipate,” “plan,” “expect,” “estimate,” “intend,” “continue,” “should,” “would,” “could,” “potentially,” “will,” “may” or similar words and expressions that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements in this Quarterly Report on Form 10-Q may include, among other things, statements about:
our expectations regarding commercialization of TYMLOS in the U.S. and, including our ability to successfully commercialize TYMLOS in the U.S.;market access coverage expectations;
the therapeutic benefits and effectiveness of TYMLOS and our investigational product candidates;candidates and the potential indications and market opportunities therefor;
our ability to obtain U.S. and foreign regulatory approval for our product candidates, including supplemental regulatory approvals for TYMLOS, and the timing thereof;
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our ability to compete with other companies that are or may be developing or selling products that are competitive with TYMLOS or our investigational product candidates;
anticipated trendsthe direct and challenges inindirect impact of the market in which TYMLOS will competeCOVID-19 pandemic on the U.S. and in other potential markets in which we may compete;global economies and our business and operations, including sales, expenses, supply chain, manufacturing, research and development costs, clinical trials and employees;
our plans with respect to collaborations and licenses related to the development, manufacture or sale of TYMLOS and our investigational product candidates;candidates,
our goals and expectations with respect to development and commercialization of RAD011, our cannabidiol oral asset (“CBD”);
our expectations with respect to development and commercialization of elacestrant by Berlin-Chemie;
our plans with respect to expanding our product portfolio;
our plans and expectations with respect to our intellectual property profile;
our expectations regarding the timing of our regulatory submissions;
our expectations for our clinical trials, including projected costs, study designs or the timing for initiation, recruitment, completion, or reporting top-line data;
the progress of, timing of and amount of expenses associated with our research, development and commercialization activities;
the safety profile and related adverse events of TYMLOS and our investigational product candidates;
the ability of our investigational product candidates to meet existing or future regulatory standards;
our expectations regarding federal, state and foreign regulatory requirements;
the success of our clinical studies for our investigational product candidates;
our expectations as to future financial performance, expense levels, future payment obligations and liquidity sources;
our ability to attract, motivate, and retain key personnel; and
other factors discussed elsewhere in this report.Quarterly Report on Form 10-Q.

The outcome of the events described in these forward-looking statements is subject to known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from the results anticipated by these forward-looking statements. These important factors include our financial performance, the uncertainties inherent in the launch of any newcommercializing pharmaceutical productproducts or the initiation, execution and completion of clinical trials, uncertainties surrounding the timing of availability of data from our clinical trials, ongoing discussions with and actions by regulatory authorities, our ability to attract and retain customers, our development activities and those other factors we discuss under the caption “Riskin Part I, “Item 1A. Risk Factors” in Item 1A of this Quarterlyour Annual Report on Form 10-Q.10-K for the year ended December 31, 2021. You should read these factors and the other cautionary statements made in this Quarterly Report on Form 10-Q as being applicable to all related forward-looking statements wherever they appear in this Quarterly Report on Form 10-Q. These important factors are not exhaustive and other sections of this Quarterly Report on Form 10-Q may include additional factors which could adversely impact our business and financial performance.
You should read the following discussion of our financial condition and results of operations in conjunction with our financial statements and related notes set forth in this report. Unless the context otherwise requires, “we,” “our,” “us”“us,” “Radius,” “Company,” and similar expressions used in this Management’s Discussion and Analysis of Financial Condition and Results of Operations section refer to Radius Health, Inc. and our consolidated entities.
Executive Overview
We are a science-driven fully integratedglobal biopharmaceutical company that is committed to developing and commercializing innovative therapeuticsfocused on addressing unmet medical needs in the areas of osteoporosis, oncologybone health, neuroscience, and endocrine diseases. Ononcology.
In April 28, 2017, our first commercial product, TYMLOS (abaloparatide) injection, was approved by the U.S. Food and Drug Administration ("FDA"(“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. WeIn May 2017, we commenced U.S. commercial sales of TYMLOS during the second quarterand as of 2017.April 1, 2022 TYMLOS was available and covered for approximately 287 million U.S. insured lives, representing approximately 99% of U.S. commercial and 73% of Medicare Part D insured lives.
We are pursuing potential additional indications for TYMLOS. In May 2017,October 2021, we announced positive top-line results from our completed 24-month ACTIVExtendPhase 3 clinical trial for TYMLOS, which met all of its primary and secondary endpoints. In July 2017, we entered into a license and development agreement with Teijin Limited (“Teijin”) forevaluating abaloparatide for subcutaneous injection (“abaloparatide-SC”) for use in Japan. Under this agreement, we received an upfront payment of $10.0 millionmales with osteoporosis (the “ATOM Trial”). The ATOM Trial met its primary and secondary endpoints and demonstrated a safety profile consistent with previous trials. We are entitled to receive additional milestone payments upon the achievement of certain regulatory and sales milestones, and a fixed low double-digit royalty based on net sales of abaloparatide-SC in Japan during the royalty term. In addition, we have an option to negotiate for a co-promotion agreement with Teijin for abaloparatide-SC in Japan. Our European Marketing Authorisation Application (“MAA”) for abaloparatide-SC is under review by the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) and we expect an opinion from the CHMP regarding the MAA prior to the end of 2017.

Our clinical pipeline includesalso developing an abaloparatide transdermal patch, or abaloparatide-TD,system (“abaloparatide-TD”) for potential
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use in the treatment of postmenopausal women with postmenopausal osteoporosis. In December 2021, we announced the results of our Phase 3 clinical trial for abaloparatide-TD, a different formulation of abaloparatide delivered using Kindeva Drug Delivery’s (“Kindeva”) patented microstructured transdermal system technology (the “wearABLe Trial”). The wearABLe Trial did not meet its primary or secondary endpoints.
We have scheduledare also developing RAD011, a pharmaceutical-grade synthetic cannabidiol oral solution, manufactured utilizing traditional pharmaceutical manufacturing processes. Based on feedback received from the Type C meeting with the FDA in January 2018 to align on a regulatory pathway for a pivotal study (e.g. bioequivalence or BMD) for abaloparatide-TD that will be initiated following completion of activities related to manufacturing scale-up, production, and other activities required for the initiation of that study. We are also discussing manufacturing arrangements with 3M Company related to potential commercial supplies of abaloparatide-TD . In addition,June 2021, we are evaluating our investigational product candidate, elacestrant (RAD1901),moving forward with a selective estrogen receptor degrader (“SERD”),potentially pivotal Phase 2/3 study for potential use in the treatment of hormone-receptor positive breast cancer, as well as for potential use in the treatment of vasomotor symptoms in postmenopausal women. We have completed enrollment in our ongoing dose escalation Part A, and dose expansion Part B and C, and in the 18F fluoroestradiol positron emission tomography (“FES-PET”) imaging Phase 1 studies of elacestrant in advanced metastatic breast cancer. In June 2017, we discussed the data from these ongoing Phase 1 studies with the FDA to gain alignment on defining the next steps for our elacestrant breast cancer program, including the design of a Phase 2 trial. Following this discussion, the FDA agreed that a single-arm monotherapy Phase 2 study of under 200 patients is appropriate and provided additional feedback on the proposed clinical protocol, including confirmation that the primary endpoint will be objective response rate (“ORR”), coupled with durability of response (“DOR”). The FDA indicated that, depending on the study results, which must demonstrate an improvement over then available therapies, the single-arm Phase 2 trial could be considered a pivotal study for accelerated approval as long as a confirmatory study is ongoing at the time of our New Drug Application ("NDA") submission. We plan to provide further study details when the Phase 2 study is started, which we expect will be in early 2018. In October 2017, the FDA granted Fast Track designation for our elacestrant breast cancer program. We are reviewing our elacestrant vasomotor development program and expect to provide an update by the end of 2017.
We are also developing our internally discovered investigational product candidate, RAD140, a non-steroidal selective androgen receptor modulator ("SARM") for potential use in the treatment of hormone-receptor positive breast cancer. In September 2017, we initiated a Phase 1 study of RAD140hyperphagia-related behavior in patients with locally advanced or metastatic breast cancer.Prader-Willi syndrome (“PWS”) in the first half of 2022. We also plan to initiate, on a gated basis, two additional clinical trials in Angelman syndrome (“AS”), with the goal of reducing seizures, and infantile spasms (“IS”), with the goal of spasm resolution. RAD011 has been granted Orphan Drug Designation by the FDA for treatment of PWS, AS and IS.
Abaloparatide
On April 28, 2017, the FDA approved We have developed or targeted two formulations of abaloparatide: abaloparatide-SC and abaloparatide-TD.
Abaloparatide-SC
TYMLOS for the(abaloparatide-SC) is an FDA-approved treatment offor 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 developing two formulations of abaloparatide: abaloparatide-SC and abaloparatide-TD.
Abaloparatide-SC
TYMLOS was approved in the United States in April 2017 for the treatment of postmenopausal women with osteoporosis at high risk for fracture. The first commercial sales of TYMLOS in the United States occurred in the second quarter of 2017. We are commercializing TYMLOS in the United States through our internal commercial organization. We hold worldwide commercialization rights to abaloparatide-SC, except for Japan and Canada, where we have an optionare entitled to negotiate a co-promotion agreement with Teijin for abaloparatide-SC. In December 2014, we announced positive 18-month top-line data from our Phase 3 ACTIVE clinical trial. These results were published inreceive milestones and royalties based on the Journal of the American Medical Association ("JAMA") in August 2016. In June 2015, we announced the positive top-line data from the first six months of the ACTIVExtend clinical trial of TYMLOSdevelopment and the 25-month combined fracture data from the ACTIVE and ACTIVExtend clinical trials. These data were published in the Mayo Clinic Proceedings in February 2017.
The combined 25-month fracture data from our Phase 3 clinical trial program for TYMLOSformed the basis of our regulatory submissions in the United States and Europe. In November 2015, we submitted an MAA for abaloparatide-SC to the EMA, which was validated and is currently undergoing active regulatory assessment by the CHMP. In July 2017, the CHMP issued a second Day-180 List of Outstanding Issues and requested additional data analyses related to the safety and efficacy of abaloparatide-SC in the process of their ongoing regulatory review. We expect that the CHMP may adopt an opinion regarding our MAA prior to the end of 2017. Assuming regulatory success, we intend to enter into one or more collaborations for the commercialization of abaloparatide-SC outside of the United States prior to commercial launch in the European Union.
In May 2017, we announced positive top-line results from the completed 24-month ACTIVExtend clinical trial of TYMLOS, which met all of its primaryunder our license and secondary endpoints. In ACTIVExtend, patients who had completed 18 months of TYMLOS (abaloparatide) injections or placebo in the ACTIVE Phase 3 trial were transitioned to receive 24 additional months of open-label alendronate. For the subset of ACTIVE trial patients (n=1139) that enrolled in the ACTIVExtend trial, the previous TYMLOS-treated patients had a significant 84% relative risk reduction (p<0.0001) in the incidence of new vertebral fractures compared with patients who received placebo followed by alendronate. They also demonstrated a 39% risk reduction in nonvertebral fractures (p=0.038), a 34% risk reduction clinical fractures (p=0.045) and a 50% risk reduction in major osteoporotic fractures (p=0.011) compared with patients who received placebo followed by alendronate. At the 43-month timepoint, for all patients (n=1645) that enrolled in the ACTIVE trial, TYMLOS-treated patients had a statistically significant

risk reduction in new vertebral fractures (p<0.0001), nonvertebral fractures (p=0.038), clinical fractures (p=0.045), and major osteoporotic fractures (p<0.001), compared with patients who received placebo followed by alendronate. While not a pre-specified endpoint, there was also a statistically significant risk reduction in hip fractures (p=0.027) at the 43-month time point in the TYMLOS-treated patients, compared with patients who received placebo followed by alendronate. The adverse events reported during the alendronate treatment period were similar between the previous TYMLOS-treated patients and the previous placebo group. The incidences of cardiovascular adverse events including serious adverse events were similar between groups. There have been no cases of osteonecrosis of the jaw or atypical femoral fracture in the entire TYMLOS development program. The results from the completed ACTIVExtend trial were presented at a major scientific meeting in September 2017 and we plan to submit a labeling supplement in connection with this data to the FDA prior to the end of 2017.agreements.
In July 2017, we entered into a license and development agreement with Teijin Pharma Limited (“Teijin”) for abaloparatide-SC in Japan. In May 2020, we announced that Teijin submitted an NDA for abaloparatide-SC in Japan for the treatment of osteoporosis in patients who are high risk of fracture and in March 2021, we announced the approval in Japan of Ostabaro® abaloparatide acetate for the treatment of osteoporosis and for promotion of bone formation in both female and male patients with high risk of fracture in Japan. Pursuant to the agreement with Teijin, we have received an upfront payment and a regulatory milestone payment upon the approval of $10 million and weOstabaro.We may receive additional milestone payments upon the achievement of certain regulatory and sales milestones, and a fixed low double-digit royalty based on net sales of abaloparatide-SC in Japan during the royalty term.
In addition,October 2021, we have an option to negotiateannounced positive top-line results of our ATOM Trial, evaluating TYMLOS for a co-promotion agreement with Teijin for abaloparatide-SCuse in Japan.
We recently gained agreement with the FDA on the designtreatment of a clinical trial in men with osteoporosis which, if successful,osteoporosis. This study met its primary endpoint of change in lumbar spine bone mineral density (“BMD”) at 12 months compared to placebo, demonstrating statistical significance after 12 months. It also met secondary endpoints of change in lumbar spine BMD at 6 months compared to placebo, change in total hip BMD at 12 months compared to placebo, and change in femoral neck BMD at 12 months compared to placebo. We expect that these results will form the basis of a supplemental NDA seeking to expand the use of TYMLOS to treatincrease bone mass in men with osteoporosis at high risk for fracture. The study will beATOM Trial was a randomized, double-blind, placebo-controlled trial that will enroll approximately 225enrolled 228 men with osteoporosis. The primary endpoint is change in lumbar spine bone mineral density (“BMD”)BMD at 12 months compared with placebo. In previous clinical trials, TYMLOS has demonstrated increases in previous clinical trials that it increases BMD in postmenopausal women. The study will includeATOM Trial includes specialized high-resolution imaging to examine the effect of abaloparatide on bone structure, such as the hip, in a subset of the study participants. We expect to initiateOn February 25, 2022, the trialCompany filed a Supplemental New Drug Application (“sNDA”) with the FDA for TYMLOS subcutaneous injection in men with osteoporosis at high risk for fracture. The sNDA filing will be a 10-month FDA review and is based on the first quarter of 2018.data from the Phase 3 ATOM study that was announced on October 18, 2021.
Abaloparatide-TD
In December 2021, we announced Phase 3 top-line results from the wearABLe Trial, which evaluated the non-inferiority of abaloparatide-TD as compared to TYMLOS. The trial did not meet its primary endpoint, as patients treated with abaloparatide-TD demonstrated an increase of 7.1% in lumbar spine BMD versus an increase of 10.9% for those treated with TYMLOS. The wearABLe Trial similarly did not meet its secondary endpoint. The wearABLe study was a single, pivotal, randomized, open label, active controlled, BMD non-inferiority bridging study with an enrollment of approximately 500 patients with postmenopausal osteoporosis at high risk of fracture.
We, along with our partner Kindeva, continue to evaluate all strategic options for the abaloparatide-TD program.
RAD011
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We are also developing abaloparatide-transdermal, which we refer to as abaloparatide-TD, based on 3M’s patented Microstructured Transdermal System technology for potential use asRAD011, a short wear-time transdermal patch.pharmaceutical-grade synthetic cannabidiol oral solution, manufactured utilizing traditional pharmaceutical manufacturing processes. We hold worldwide commercialization rightsacquired RAD011 from Fresh Cut Development, LLC and Benuvia Therapeutics Inc. in December 2020. Prior to the abaloparatide-TD technology. We are developing abaloparatide-TD toward future global regulatory submissions to build uponCompany’s acquisition of RAD011, it was granted fast track designation by the potential successFDA in 2017 and orphan drug designation in August 2020 for the treatment of TYMLOS. We commencedhyperphagia behavior and weight loss in patients with PWS. In June 2021, we participated in a human replicative clinical evaluation of the optimized abaloparatide-TD patch in December 2015, with the goal of achieving comparability to TYMLOS. In September 2016, we presented results from this evaluation, which showed that the pharmacokinetic profile of an optimized abaloparatide-TD patch with respect to Tmax, T1/2, and AUC was successfully modified so as to improve comparability to TYMLOS. We have schedule aType C meeting with the FDA in January 2018 to aligndiscuss initiation of a potentially pivotal Phase 2/3 study for treatment of PWS. Based on a regulatory pathway for afeedback from that meeting, we intend to initiate the potentially pivotal study. This Synthetic Cannabidiol Oral Solution (“SCOUT”) 015 study (e.g. bioequivalence or BMD) for abaloparatide-TD that will be initiated following completion of activities relateda randomized double-blind placebo-controlled seamless Phase 2/3 trial designed to manufacturing scale-up, production, and other activities requiredsupport a 505(b)(2) NDA submission for the initiation of that study. We are also discussing manufacturing arrangements with 3M Company related to potential commercial supplies of abaloparatide-TD.
Commercial, Medical and Compliance Organizations
We are commercializing TYMLOS in the United States through our field-based sales organization of more than 200 regional sales managers and clinical sales specialists who are experienced in launching specialty pharmaceutical products, including many with osteoporosis sales experience.
After receiving regulatory approval of TYMLOS in the United States in April 2017RAD011 for the treatment of postmenopausal women at high riskhyperphagia in patients with PWS. We will move forward with the development of osteoporotic fracture, we have focused commercial effortsRAD011 as not scheduled under the Controlled Substance Act (“CSA”) based on increasing access to, and utilizationguidance from the U.S. Drug Enforcement Administration (“DEA”). The guidance states that if a product does not contain any quantity of TYMLOS. We havesynthetic tetrahydrocannabinol (“THC”) (or any other controlled substance), it is not controlled under the CSA. RAD011 is not scheduled as it does not contain traceable amounts of THC or any other controlled substance. The Company anticipates initiating a commercialization team that includes experienced professionals in marketing, communications, professional education, patient education, reimbursement and market access, trade, distribution and call centers, commercial operations, commercial analytics, market research, and forecasting.
We also have a distribution network of well-established distributors and specialty pharmaciesseamless Phase 2/3 study for TYMLOSpatients with PWS in the United States. Underfirst half of 2022, as well as for patients with AS and AI.
Elacestrant (RAD1901)
In October 2021, we and our distribution model, bothlicensee, Berlin-Chemie AG, a company of the distributors and specialty pharmacies take physical delivery of TYMLOS andMenarini Group (“Berlin-Chemie”), together announced positive top-line results from the specialty pharmacies dispense TYMLOS directly to patients.
Our medical organization is comprised of approximately 40 professionals, many field-based, with clinical and scientific experience within academic medical centers, clinical medical practice, research institutions, and industry. Our team is organized by key functions, including medical affairs, pharmacovigilance, medical information, publications, and health economics outcomes research.
Under the leadershipEMERALD Phase 3 study of our Chief Compliance Officer, we have implemented investigational product candidate elacestrant, a compliance program in support of a strong culture of compliance and good corporate governance. Our leadership, managers and staff have devoted substantial amounts of time to compliance initiatives, including establishing and maintaining effective disclosure and financial controls and corporate

governance practices, as required by the Sarbanes-Oxley Act of 2002, as amended, and rules subsequently implemented by the Securities and Exchange Commission ("SEC") and NASDAQ.
Elacestrant (RAD1901)
Elacestrant (RAD1901) is a SERD that has potential for use as a once daily oral treatment for hormone-receptor positive breast cancer. We hold worldwide commercialization rights to elacestrant. Elacestrant is currently being investigated in women with advancedselective estrogen receptor positive, or ER-positive, and HER2-negative, or human epidermal receptor 2 negative, breast cancer, the most common subtype of the disease. Studies completed to date indicate that the compound has the potential for use as a single agent or in combination with other therapies for the treatment of breast cancer. In April 2017, we presented new preclinical data on the impact of elacestrant in preclinical models of endocrine sensitive/resistant breast cancer.In October 2017, the FDA granted Fast Track designation for elacestrant - a process the FDA designed to facilitate the development and expedite the review of new therapies to treat serious conditions and fill unmet medical needs.
degrader (“SERD”). The EMERALD Phase 1 - Dose-Escalation and Expansion Study
In December 2014, we commenced a Phase 1, multicenter, open-label, multiple-part, dose-escalation study of elacestrant in postmenopausal women with ER-positive and HER2-negative advanced breast cancer in the United States to determine the recommended dose for a Phase 2 clinical trial and to make a preliminary evaluation of the potential anti-tumor effect of elacestrant. Part A of this Phase 13 study was designed to evaluate escalating doseselacestrant as a second or third-line monotherapy versus the standard of elacestrant. The Part B expansion cohort was initiated at 400-mg daily dosing in March 2016 to allowcare for an evaluationtreatment of additional safety, tolerability and preliminary efficacy. The patients enrolled in this study are heavily pretreated ER-positive, HER2-negative advanced breast cancer patients who have received a median of 3 prior lines of therapy including fulvestrant and CDK4/6 inhibitors, and about 50% of the patients had ESR1 mutations. We have completed enrollment in the ongoing dose-escalation Part A and expansion study parts B and C. We have recently opened a Part D cohort in this study to provide additional data on a more homogeneous and genetically defined patient population to support our overall elacestrant clinical development program and anticipated regulatory submissions.
In December 2016, we reported positive results from this ongoing Phase 1 dose-escalation and expansion study. These results showed that elacestrant was well-tolerated with the most commonly reported adverse events being low grade nausea and dyspepsia. Enrollment in the Part C tablet dosage form cohort was completed in November 2016.
In June 2017, we reported additional positive data from this ongoing Phase 1 dose-escalation and expansion study. As of the study cut-off date of April 28, 2017, the elacestrant single agent ORR, was 23% with five confirmed partial responses in heavily pre-treated patients with advanced ER-positive breast cancer. In the 400-mg patient group of 26 patients with mature data, the median progression free survival was 4.5 months. These results showed that elacestrant was well-tolerated with the most commonly reported adverse events being low grade nauseaestrogen receptor-positive (“ER+”) and dyspepsia.
Phase 1 - FES-PET Study
In December 2015, we commenced a Phase 1 FES-PET study in patients with metastatic breast cancer in the European Union which includes the use of FES-PET imaging to assess estrogenhuman epidermal growth factor receptor occupancy in tumor lesions following elacestrant treatment. We have completed patient enrollment in the European Phase I FES-PET study.
In December 2016, we reported positive results from the ongoing Phase 1 FES-PET study. The first three enrolled patients dosed at the 400-mg cohort had a tumor FES-PET signal intensity reduction ranging from 79% to 91% at day 14 compared to baseline. The most commonly reported adverse events reported to date in this study have been grade 1 and 2 nausea and dyspepsia. We enrolled 5 additional patients in the 400-mg daily oral cohort, followed by 8 patients in the 200-mg daily oral cohort.
Phase 1 - Recent Progress
To date, no dose limiting toxicities have been reported in the elacestrant program. We have completed enrollment in our ongoing FES-PET imaging study and dose-escalation Part A and expansion study parts B and C Phase 1 breast cancer trials. In June 2017, we discussed the data from the ongoing Phase 1 studies with the FDA to gain alignment on defining the next steps for our elacestrant breast cancer program, including the design of a Phase 2 trial. Following this discussion, the FDA agreed that a single-arm monotherapy Phase 2 study of under 200 patients is appropriate and provided additional feedback on the proposed clinical protocol, including confirmation that the primary endpoint will be ORR, coupled with DOR. The FDA indicated that, depending on the study results, which must demonstrate an improvement over then available therapies, the single-arm Phase 2 trial could be considered a pivotal study for accelerated approval as long as a confirmatory study is ongoing at the time of our NDA submission. We plan to provide further study details when the Phase 2 study is started, which we expect will be in early 2018.

Potential for use in Combination Therapy
In July 2015, we announced that early but promising preclinical data showed that our investigational drug elacestrant, in combination with Pfizer’s palbociclib, a cyclin-dependent kinase, or CDK 4/6 inhibitor, or Novartis’ everolimus, an mTOR inhibitor, was effective in shrinking tumors. In preclinical patient-derived xenograft breast cancer models with either wild type or mutant ESR1, treatment with elacestrant resulted in marked tumor growth inhibition, and the combination of elacestrant with either agent, palbociclib or everolimus, showed anti-tumor activity that was significantly greater than either agent alone. We believe that this preclinical data suggests that elacestrant has the potential to overcome endocrine resistance, is well-tolerated, and has a profile that is well suited for use in combination therapy.
Collaborations
In July 2016, we entered into a preclinical collaboration with Takeda Pharmaceutical Company Limited to evaluate the combination of our investigational drug elacestrant with Takeda's investigational drug TAK-228, an oral mTORC 1/2 inhibitor in Phase 2b development for the treatment of breast, endometrial and renal cancer, with the goal of potentially exploring such combination in a clinical study.
In January 2016, we entered into a worldwide clinical collaboration with Novartis Pharmaceuticals to evaluate the safety and efficacy of combining our investigational drug elacestrant, with Novartis’ investigational agent LEE011 (ribociclib), a CDK 4/6 inhibitor, and BYL719 (alpelisib), an investigational phosphoinositide 3-kinase inhibitor. We expect the results from these studies will be presented at an upcoming scientific meeting.
Vasomotor Symptoms
Elacestrant is also being evaluated at low doses as an estrogen receptor ligand for the potential relief of the frequency and severity of moderate to severe hot flashes in postmenopausal women with vasomotor symptoms. We are currently reviewing our elacestrant vasomotor development program and plan to provide an update by the end of 2017.
RAD140
RAD140 is an internally discovered SARM. The androgen receptor, or AR, is highly expressed in many ER-positive, ER-negative, and triple-negative receptor breast cancers. Due to its receptor and tissue selectivity, potent activity, oral bioavailability, and long half-life, we believe RAD140 could have clinical potential in the treatment of breast cancer. We hold worldwide commercialization rights to RAD140.
In September 2017, we initiated a Phase 1 study of RAD140 in patients with locally2-negative (“HER2-”) advanced or metastatic breast cancer. The clinical trial is designedstudy met both primary endpoints, demonstrating statistically significant progression-free survival in the overall population and in patients with tumors harboring estrogen receptor 1 (“ESR1”) mutations. Based on these results, in the second quarter of 2022, we expect to evaluateproceed with applications for marketing approval in the safetyUnited States and maximum tolerated dose of RAD140the European Union in approximately 40 patients. Primary safety outcomes from the trial include rate of dose-limiting toxicities, adverse events relatedcollaboration with Berlin-Chemie.
Berlin-Chemie holds an exclusive, worldwide license to treatment,develop and tolerability as measured by dose interruptions or adjustments. In addition, pharmacokinetics, pharmacodynamics and tumor response will also be evaluated.
In July 2016, we reported that RAD140 in preclinical xenograft models of breast cancer demonstrated potent tumor growth inhibition when administered alone or in combinations with CDK4/6 inhibitors. It is estimated that 77% of breast cancers show expressioncommercialize products containing elacestrant. For a more detailed discussion of the androgen receptor. Our data suggest that RAD140 activity atterms of our license agreement with Berlin-Chemie, please see Note 9 in the androgen receptor leadsNotes to activationCondensed Consolidated Financial Statements included in Part I, Item 1 of AR signaling pathways including an AR-specific tumor suppressor and suppression of ER signaling. In April 2017, we presented these RAD140 preclinical results at a major scientific congress.this Quarterly Report on Form 10-Q.
Financial Overview
Product Revenue
Product revenue is derived from our sales of our commercial product, TYMLOS,TM, in the United States.
License Revenue
License revenue is derived from payments received from contracts with customers, which includes upfront payments for licenses.
Cost of Product Revenue
Cost of product revenue consist primarily of costs associated with the manufacturing of TYMLOS, royalties owed to our licensor for such sales, and certain period costs.
Research and Development Expenses
Research and development expenses consist primarily of clinical testingtrial costs made to contract research organizations ("CROs"(“CROs”), salaries and related personnel costs, fees paid to consultants and outside service providers for regulatory and quality assurance support, licensing of drug compounds and other expenses relating to the manufacture, development, testing and enhancement of our product candidates. We expense our research and development costs as they are incurred.
None of the research and development expenses, in relation to our investigational product candidates, are currently borne by third parties. TYMLOS (abaloparatide) historically has representedparties, with the exception of elacestrant (“RAD1901”). Abaloparatide represents the largest portion of our research and development expenses for our development programs.investigational product candidates since our inception. We began tracking program expenses for TYMLOS (abaloparatide)(abaloparatide-SC) in 2005, and program expenses from inception to September 30, 2017March 31, 2022 were approximately $213.5$261.3 million. We began tracking program

expenses for abaloparatide-TD in 2007, and program expenses from inception to September 30, 2017March 31, 2022 were approximately $41.4$195.1 million. We began tracking program expenses for elacestrant (RAD1901)RAD1901 in 2006, and program expenses from inception to September 30, 2017March 31, 2022 were approximately $62.5$130.1 million. We began tracking program expenses for RAD140 in 2008, and program expenses from inception to September 30, 2017March 31, 2022 were approximately $10.5$18.0 million. We began tracking program expenses for RAD011 in 2020, and program expenses from inception to March 31, 2022 were approximately
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$31.1 million. These expenses relate primarily to external costs associated with manufacturing, preclinical studies and clinical trial costs.
Costs related to facilities, depreciation, stock-basedshare-based compensation, and research and development support services are not directly charged to programs as they benefit multiple research programs that share resources.
The following table sets forth our research and development expenses that are directly attributable to the programs listed below for the three and nine months ended September 30, 2017March 31, 2022 and 20162021 (in thousands):
 Three Months Ended September 30, Nine Months Ended September 30,
 2017 2016 2017 2016
Abaloparatide-SC*$311
 $2,358
 $608
 $14,748
Abaloparatide-TD1,308
 855
 2,340
 4,545
Elacestrant (RAD1901)4,083
 8,605
 6,990
 21,865
RAD140245
 699
 1,566
 1,826
*2017 expenses were net of the FDA's refund of NDA fees of $2.4 million previously paid and expensed in the first quarter of 2016.
Three Months Ended March 31,
 20222021
Program-specific costs - external:
Abaloparatide-SC$2,113 $7,609 
Abaloparatide-TD3,157 10,448 
Elacestrant (RAD1901)(2,907)1,409 
RAD140— 93 
RAD0115,772 
Total program-specific costs - external$8,135 $19,568 
Shared-services costs - external:
R&D support costs4,996 7,366 
Other operating costs840 206 
Total shared-services costs - external$5,836 $7,572 
Shared-services costs - internal
Personnel-related costs7,076 2,649 
Share-based compensation1,242 1,601 
Occupancy costs368 10 
Depreciation expense40 40 
Total shared-services costs - internal$8,726 $4,300 
Total research and development costs$22,697 $31,440 
Selling, General and Administrative Expenses
Selling, general and administrative expenses consist primarily of salaries and related expenses for pre-launch and post-launch commercial operations, executive, finance and other administrative personnel, professional fees, business insurance, rent, general legal activities, including the cost of maintaining our intellectual property portfolio, and other corporate expenses.
Our results also include stock-basedshare-based compensation expense including as a result of the issuance of stock option, restricted stock unit, and performance unit grants to our employees, directors and consultants. The stock-basedshare-based compensation expense is included in the respective categories of expense in the statementour condensed consolidated statements of operations and comprehensive loss (i.e., research and development or selling, general and administrative expenses). We expect to record additional non-cash compensation expense in the future, which may be significant.
Interest Income and Other Income
Interest income reflects interest earned on our cash, cash equivalents and marketable securities. Other income for the first half of 2017 reflects a portion of the Massachusetts Life Science Center awards recognized as income for certain taxes paid.equivalents.
Interest Expense
Interest expense consists of interest expense related to the Convertible Notes.Notes the Company issued in a registered unwritten public offering on August 14, 2017 (“Convertible Notes”) and Amended and Restated Credit and Security Agreement with MidCap Financial Trust (“Term Loan”) the Company refinanced on March 3, 2021. A portion of the interest expense on the Convertible Notes is non-cash expense relating to accretion of the debt discount and amortization of issuance costs.
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Critical Accounting Policies and Estimates
Our management’s discussion and analysis of financial condition and results of operations is based upon our consolidated financial statements, which have been prepared in accordance with the rules and regulations of the Securities and Exchange Commission ("SEC"(“SEC”), and generally accepted accounting principles in the United States ("(“U.S. GAAP"GAAP”). The preparation of these financial statements requires us to make estimates and judgmentsassumptions that affect the reported amounts of assets and liabilities and expenses,the disclosure of contingent assets and liabilities at the date of the financial statements, as well as related disclosures.reported revenues and expenses during the reporting periods. We evaluate our policiesestimates and estimatesjudgements on an ongoing basis, including those related to revenue recognition, accrued clinical expenses, research and development expenses, stock-basedshare-based compensation, and fair value measures, among others, which we discussed in our Annual Report on Form 10-K for the year ended December 31, 2016.2021. We base our estimates on historical experience and various other assumptions that we believe are reasonable under the circumstances.circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Our actual results may differ from these estimates under different assumptions or conditions.
We have reviewed our policies and estimates to determine our critical accounting policies for the three and nine months ended September 30, 2017.March 31, 2022. There were no changes to significant accounting policies during the ninethree months ended September 30, 2017,March 31, 2022, except for the adoption of two Accounting Standards Updatescertain ASUs issued by the Financial Accounting Standards Board,FASB, as well as significant accounting policies over revenue, inventory, and intangibles, each of which is detailed below, except intangibles, which is not considered a critical accounting policy and estimate by management.

Stock-based Compensation- In March 2016, the FASB issued Accounting Standards Update No. 2016-09, Improvements to Employee Share-Based Payment Accounting (“ASU 2016-09”). This revised standard affects the accounting for forfeitures, cash flow presentation and income taxes. Specifically, this standard provides an accounting policy election to account for forfeitures as they occur, requires all excess tax benefits and deficiencies on share-based payment awards to be recognized as income tax expense or benefit in the statement of operations, requires the tax effects of exercised or vested awards should be treated as discrete items in the reporting period in which they occur, and requires that excess tax benefits to be classified with other income tax cash flows as an operating activity. The standard permits early adoption in any annual or interim period and will be applied by means of a cumulative-effect adjustment to retained earnings as of the beginning of the fiscal year of adoption.
Historically, the Company recognized stock-based compensation net of estimated forfeitures over the vesting period of the respective grant. Effective January 1, 2017, the Company adopted ASU 2016-09 and changed its accounting policy to recognize forfeitures as they occur. The new forfeiture policy election was adopted using a modified retrospective approach with a cumulative effect adjustment ofapproximately $0.5 millionto retained earnings as of January 1, 2017. In addition, the Company recognized $6.1 million of accumulated excess tax benefits as deferred tax assets that under the previous guidance could not be recognized until the benefits were realized through a reduction in cash taxes paid. This part of the guidance was applied using a modified retrospective method with a cumulative-effect adjustment to the accumulated deficit for the excess tax benefits not previously recognized. However, given the full valuation allowance placed on the additional $6.1 million of deferred tax assets, the recognition upon adoption had no impact to our accumulated deficit as of January 1, 2016. The adoption of ASU 2016-09 effective January 1, 2017 had no other material impacts on the Company’s results of operations, financial position or cash flows.
Revenue RecognitionOn April 28, 2017, the FDA approved TYMLOS in the U.S. Subsequent to receiving FDA approval, the Company entered into a limited number of arrangements with wholesalers in the U.S. (collectively, its “Customers”) to distribute TYMLOS. These arrangements are the Company’s initial contracts with customers and, as a result, the Company adopted Accounting Standards Codification (“ASC”) Topic 606 - Revenue from Contracts with Customers (“Topic 606”). There is no transition to Topic 606 because the Company has no historical revenue. This standard applies to all contracts with customers, except for contracts that aredisclosed above within the scope of other standards, such as leases, insurance, collaboration arrangements, and financial instruments. Under Topic 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to be entitled in exchange for those goods or services.
To determine revenue recognition for arrangements that an entity determines are within the scope of Topic 606, the entity performs the following five steps: (i) identify the contract(s) with a customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations in the contract, and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to arrangements that meet the definition of a contract under Topic 606, including when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of Topic 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.
Product Revenue, Net— The Company sells TYMLOS to a limited number of wholesalers in the U.S (collectively, its "Customers"). These Customers subsequently resell the Company’s products to specialty pharmacy providers, as well as other retail pharmacies and certain medical centers or hospitals. In addition to distribution agreements with Customers, the Company enters into arrangements with health care providers and payors that provide for government mandated and/or privately negotiated rebates, chargebacks, and discounts with respect to the purchase of the Company’s products.
The Company recognizes revenue on product sales when the Customer obtains control of the Company's product, which occurs at a point in time (upon delivery). Product revenues are recorded net of applicable reserves for variable consideration, including discounts and allowances.
If taxes should be collected from Customers relating to product sales and remitted to governmental authorities, they will be excluded from revenue. The Company expenses incremental costs of obtaining a contract when incurred, if the expected amortization period of the asset that the Company would have recognized is one year or less. However, no such costs were incurred during the three and nine months ended September 30, 2017.
Reserves for Variable Consideration— Revenues from product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established. Components of variable consideration include trade discounts and allowances, product returns, provider chargebacks and discounts, government rebates, payor

rebates, and other incentives, such as voluntary patient assistance, and other allowances that are offered within contracts between the Company and its Customers, payors, and other indirect customers relating to the Company’s sale of its products. These reserves, as detailed below, are based on the amounts earned, or to be claimed on the related sales, and are classified as reductions of accounts receivable (if the amount is payable to the Customer) or a current liability (if the amount is payable to a party other than a Customer). These estimates take into consideration a range of possible outcomes which are probability-weighted in accordance with the expected value method in Topic 606 for relevant factors such as current contractual and statutory requirements, specific known market events and trends, industry data, and forecasted customer buying and payment patterns. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the respective underlying contracts.
The amount of variable consideration which is included in the transaction price may be constrained, and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized under the contract will not occur in a future period. The Company’s analyses also contemplated application of the constraint in accordance with the guidance, under which it determined a material reversal of revenue would not occur in a future period for the estimates detailed below as of September 30, 2017 and, therefore, the transaction price was not reduced further during the three and nine months ended September 30, 2017. Actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results in the future vary from the Company’s estimates, the Company will adjust these estimates, which would affect net product revenue and earnings in the period such variances become known.
Trade Discounts and Allowances— The Company generally provides Customers with discounts which include incentive fees that are explicitly stated in the Company’s contracts and are recorded as a reduction of revenue in the period the related product revenue is recognized. In addition, the Company compensates (through trade discounts and allowances) its Customers for sales order management, data, and distribution services. However, the Company has determined such services received to date are not distinct from the Company’s sale of products to the Customer and, therefore, these payments have been recorded as a reduction of revenue within the statement of operations and comprehensive loss through September 30, 2017, as well as a reduction to trade receivables, net on the condensed consolidated balance sheets.
Product Returns— Consistent with industry practice, the Company generally offers Customers a limited right of return for product that has been purchased from the Company based on the product’s expiration date, which lapses upon shipment to a patient. The Company estimates the amount of its product sales that may be returned by its Customers and records this estimate as a reduction of revenue in the period the related product revenue is recognized, as well as reductions to trade receivables, net on the condensed consolidated balance sheets. The Company currently estimates product return liabilities using available industry data and its own sales information, including its visibility into the inventory remaining in the distribution channel. The Company has received an immaterial amount of returns to date and believes that returns of product in future periods will be minimal.
Provider Chargebacks and Discounts— Chargebacks for fees and discounts to providers represent the estimated obligations resulting from contractual commitments to sell products to qualified healthcare providers at prices lower than the list prices charged to Customers who directly purchase the product from the Company. Customers charge the Company for the difference between what they pay for the product and the ultimate selling price to the qualified healthcare providers. These reserves are established in the same period that the related revenue is recognized, resulting in a reduction of product revenue and trade receivables, net. Chargeback amounts are generally determined at the time of resale to the qualified healthcare provider by Customers, and the Company generally issues credits for such amounts within a few weeks of the Customer’s notification to the Company of the resale. Reserves for chargebacks consist of credits that the Company expects to issue for units that remain in the distribution channel inventories at each reporting period-end that the Company expects will be sold to qualified healthcare providers, and chargebacks that Customers have claimed, but for which the Company has not yet issued a credit.
Government Rebates— The Company is subject to discount obligations under state Medicaid programs and Medicare. These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included in accrued expenses and other current liabilities on the condensed consolidated balance sheets. For Medicare, the Company also estimates the number of patients in the prescription drug coverage gap for whom the Company will owe an additional liability under the Medicare Part D program. The Company’s liability for these rebates consists of invoices received for claims from prior quarters that have not been paid or for which an invoice has not yet been received, estimates of claims for the current quarter, and estimated future claims that will be made for product that has been recognized as revenue, but which remains in the distribution channel inventories at the end of each reporting period.
Payor Rebates— The Company contracts with certain private payor organizations, primarily insurance companies and pharmacy benefit managers, for the payment of rebates with respect to utilization of its products. The Company estimates these rebates and records such estimates in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability.

Other Incentives— Other incentives which the Company offers include voluntary patient assistance programs, such as the Company's co-pay assistance program, which are intended to provide financial assistance to qualified commercially-insured patients with prescription drug co-payments required by payors. The calculation of the accrual for co-pay assistance is based on an estimate of claims and the cost per claim that the Company expects to receive associated with product that has been recognized as revenue, but remains in the distribution channel inventories at the end of each reporting period. The adjustments are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included as a component of accrued expenses and other current liabilities on the condensed consolidated balance sheets.
Collaboration Revenues— The Company enters into out-licensing agreements which are within the scope of Topic 606, under which it licenses certain rights to its product candidates to third parties. The terms of these arrangements typically include payment to the Company of one or more of the following: non-refundable, up-front license fees; development, regulatory, and commercial milestone payments; payments for manufacturing supply services the Company provides through its contract manufacturers; and royalties on net sales of licensed products. Each of these payments may result in license, collaboration, or other revenue, except revenue from royalties on net sales of licensed products, which would be classified as royalty revenue.
In determining the appropriate amount of revenue to be recognized as it fulfills its obligations under each of its agreements, the Company performs the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation. As part of the accounting for these arrangements, the Company must develop assumptions that require judgment to determine the stand-alone selling price for each performance obligation identified in the contract. The Company uses key assumptions to determine the stand-alone selling price, which may include forecasted revenues, development timelines, reimbursement rates for personnel costs, discount rates, and probabilities of technical and regulatory success.
Licenses of Intellectual PropertyIf the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenue from non-refundable, up-front fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. The Company will evaluate the measure of progress each reporting period and, if necessary, adjust the measure of performance and related revenue recognition.
Milestone PaymentsAt the inception of each arrangement that includes development milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the customer, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as, or when, the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company will re-evaluate the probability of achievement of such development milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect license, collaboration, other revenue, and earnings in the period of adjustment.
Manufacturing Supply ServicesArrangements that include a promise for future supply of drug substance or drug product for either clinical development or commercial supply, at the customer’s discretion, are generally considered as options. The Company assesses if these options provide a material right to the licensee and, if so, they are accounted for as separate performance obligations. If the Company is entitled to additional payments when the licensee exercises these options, any additional payments are recorded in license, collaboration, or other revenue when the customer obtains control of the goods, which is upon delivery.
RoyaltiesFor arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all the royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized any royalty revenue resulting from its out-licensing arrangement.

Product Revenue Reserves and AllowancesChargebacks, discounts, fees, and returns are recorded as reductions of trade receivables, net on the condensed consolidated balance sheets. Government and other rebates are recoded as a component of accrued expenses and other current liabilities on the condensed consolidated balance sheets.
Inventory— The Company values its inventories at the lower of cost or estimated net realizable value. The Company determines the cost of its inventories, which includes amounts related to materials and manufacturing overhead, on a first-in, first-out basis. The Company performs an assessment of the recoverability of capitalized inventory during each reporting period, and it writes down any excess and obsolete inventories to their estimated realizable value in the period in which the impairment is first identified. Such impairment charges, should they occur, are recorded within cost of product revenues. The determination of whether inventory costs will be realizable requires estimates by management. If actual market conditions are less favorable than projected by management, additional write-downs of inventory may be required, which would be recorded as a cost of product sales in the consolidated statements of operations and comprehensive loss.
The Company capitalizes inventory costs associated with the Company’s products after regulatory approval when, based on management’s judgment, future commercialization is considered probable and the future economic benefit is expected to be realized. Inventory acquired prior to receipt of marketing approval of a product candidate is expensed as research and development expense as incurred. Inventory that can be used in either the production of clinical or commercial product is expensed as research and development expense when selected for use in a clinical manufacturing campaign.
Shipping and handling costs for product shipments are recorded as incurred in cost of product revenues along with costs associated with manufacturing the product, and any inventory write-downs.
Results of Operations
Three Months Ended September 30, 2017 and 2016 (in thousands, except percentages)
 Three Months Ended    
 September 30, Change
 2017 2016 $ %
Revenues:       
Product revenue, net$3,469
 $
 $3,469
 100 %
License revenue10,000
 
 10,000
 100 %
Operating expenses:

       
Cost of sales - product253
 
 253
 100 %
Cost of sales - intangible amortization200
 
 200
 100 %
Research and development20,997
 27,453
 (6,456) (24)%
Selling, general and administrative47,723
 19,240
 28,483
 148 %
Loss from operations(55,704) (46,693) 9,011
 19 %
Other (expense) income: 
  
  
  
Other expense, net(195) (78) 117
 150 %
Interest expense(2,763) 
 2,763
 100 %
Interest income819
 585
 234
 40 %
Net loss$(57,843) $(46,186) $11,657
 25 %
Product revenue— We began commercial sales of TYMLOS within the United States in May 2017, following receipt of FDA marketing approval on April 28, 2017. For the three months ended September 30, 2017 we recorded approximately $3.5 million of net product revenue. For further discussion regarding our revenue recognition policy, see Note 2, “Basis of Presentation and Significant Accounting Policies”,Policies,” in the Notes to Condensed Consolidated Financial Statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q.
CostResults of salesCost of sales of $0.5 million for the three months ended September 30, 2017, consisted of costs associated with the manufacturing of TYMLOS, royalties owed to our licensor for such sales, and certain period costs. Based on our policy to expense costs associated with the manufacture of our products prior to regulatory approval, certain of the costs of TYMLOS units recognized as revenue during the three months ended September 30, 2017 were expensed prior to the April 2017 FDA approval and, therefore, are not included in cost of sales during this period. We expect cost of sales to increase in relation to product revenues as we deplete these inventories.Operations

Research and development expenses— For the three months ended September 30, 2017, research and development expense was $21.0 million compared to $27.5 million for the three months ended September 30, 2016, a decrease of $6.5 million, or 24%. This decrease was primarily driven by a $3.4 million decrease in vasomotor project related spending, a $2.0 million decrease in abaloparatide-SC project costs, and a $1.1 million decrease in RAD1901 oncology project costs. Additionally, there was an increase in headcount from 101 research and development employees as of September 30, 2016 to 105 research and development employees as of September 30, 2017.
Selling, general and administrative expenses— For the three months ended September 30, 2017, selling, general and administrative expense was $47.7 million compared to $19.2 million for the three months ended September 30, 2016, an increase of $28.5 million, or 148%. This increase was primarily the result of an increase of approximately $10.1 million in professional fees and support costs during the three months ended September 30, 2017, including the costs associated with increasing headcount and preparing for the commercialization of TYMLOS in the United States. This increase was also driven by a $15.2 million increase in compensation expense, including stock-based compensation, due to an increase in headcount from 90 general and administrative employees as of September 30, 2016 to 65 general and administrative employees and 296 selling related personnel as of September 30, 2017.
Interest income—For the three months ended September 30, 2017, interest income was approximately $0.8 million compared to $0.6 million for the three months ended September 30, 2016, an increase of $0.2 million, or 40%. This decrease was primarily due to the combined effects of a decrease in the balance of our investments coupled with an increase in the rate of return on investments in the three months ended September 30, 2017 as compared to those of the three months ended September 30, 2016.
Interest expense—For the three months ended September 30, 2017, interest expense was approximately $2.8 million compared to $0 for the three months ended September 30, 2016, an increase of $2.8 million, or 100%. This increase was the result of the issuance of the Convertible Notes during the three months ended September 30, 2017, while there was no debt outstanding for the three months ended September 30, 2016.
NineThree Months Ended September 30, 2017March 31, 2022 and 20162021 (in thousands, except percentages)
 Three Months Ended  
 March 31,Change
 20222021$%
Revenues:
Product revenue, net$42,958 $45,261 $(2,303)(5)%
License revenue$200 11,000 $(10,800)(98)%
Total revenue$43,158 56,261 $(13,103)(23)%
Operating expenses:
Cost of sales - product$4,060 3,925 $135 %
Cost of sales - intangible amortization$200 200 $— — 
Research and development, net of amounts reimbursable$22,697 31,440 $(8,743)(28)%
Selling, general and administrative$30,048 34,097 $(4,049)(12)%
Loss from operations$(13,847)(13,401)$(446)(3)%
Other (expense) income:    
Other income (expense), net$379 (1)$380 38,000 %
Interest expense$(4,822)(4,364)$(458)(10)%
Interest income$14 57 $(43)(75)%
Gain on extinguishment of debt$— 1,960 $(1,960)100 %
Net loss$(18,276)$(15,749)$(2,527)(16)%
 Nine Months Ended    
 September 30, Change
 2017 2016 $ %
Revenues:       
Product revenue, net$4,449
 $
 $4,449
 100 %
License revenue10,000
 
 10,000
 100 %
Operating expenses: 
  
  
  
Cost of sales - product358
 
 358
 100 %
Cost of sales - intangible amortization200
 
 200
 100 %
Research and development60,176
 81,827
 (21,651) (26)%
Selling, general and administrative135,943
 50,079
 85,864
 171 %
Loss from operations(182,228) (131,906) 50,322
 38 %
Other (expense) income: 
  
  
  
Other expense, net(212) (174) 38
 22 %
Interest expense(2,763) 
 2,763
 100 %
Interest income1,983
 1,996
 (13) (1)%
Net loss$(183,220) $(130,084) $53,136
 41 %
Product revenue— We began U.S. commercial sales of TYMLOS within the United States in May 2017, following receipt of FDA marketing approval on April 28, 2017. For the ninethree months ended September 30, 2017March 31, 2022, we recorded approximately $4.4$43.0 million of net product revenue compared to $45.3 million for the three months ended March 31, 2021. The decrease in product revenue was primarily driven by decreases in both unit volume and net sales price.
License revenue— For the three months ended March 31, 2022, we recorded $0.2 million of license revenue. For further discussion regardingIn 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 of fracture. Pursuant to our revenue recognition policy, see Note 2, “Basis of Presentationlicense and Significant Accounting Policies”,development agreement with Teijin, we recognized $10.0 million during the three months ended March 31, 2021 in connection with the Notes to Condensed Consolidated Financial Statements included in Part I, Item 1completion of this Quarterly Report on Form 10-Q.regulatory milestone. In addition, we recognized $1.0 million in license revenue in connection with other license agreements for the three months ended March 31, 2021.
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Cost of salesCost of sales of $0.6was $4.1 million for the ninethree months ended September 30, 2017, consisted of costs associated withMarch 31, 2022 and $3.9 million the manufacturing of TYMLOS, royalties owed to our licensor for such sales, and certain period costs. Based on our policy to expense costs associated with the manufacture of our products prior to regulatory approval, certain of the costs of TYMLOS

units recognized as revenue during the ninethree months ended September 30, 2017 were expensed prior toMarch 31, 2021. This increase was primarily driven by an increase foreign currency revaluation, partially offset by a decrease in the April 2017 FDA approval and, therefore, are not included in cost of sales during this period. We expect cost of sales to increase in relation to product revenues as we deplete these inventories.overhead allocation.
Research and development expenses— For the ninethree months ended September 30, 2017,March 31, 2022, research and development expense was $60.2$22.7 million compared to $81.8$31.4 million for the ninethree months ended September 30, 2016,March 31, 2021, a decrease of $21.7$8.7 million, or 26%28%. This decrease was primarily driven by a $14.9decrease of $7.3 million decrease in RAD1901 projectabaloparatide-TD program costs, a $14.1$5.5 million decrease in abaloparatide-SC projectprogram costs, a $1.0 million decrease in professional fees driven by billed reimbursable consultant costs, and a $2.2$2.1 million decrease in developmentelacestrant program costs, associated with abaloparatide-TD. Thiswhich is comprised of a $7.3 million decrease was partiallyin gross program expenses as well as a $5.2 million change in billed reimbursable expenses. These decreases were offset by a $9.7$6.1 million increase in RAD011 program costs, a $0.4 million increase in occupancy and depreciation costs, a $0.2 million increase in other operating costs, and a $0.4 million increase in compensation expense, including stock-based compensation, due to anwhich is comprised of a $1.0 million increase in compensation expense related to headcount from 101 research and development employees asoffset by $0.5 million of September 30, 2016 to 105 research and development employees as of September 30, 2017.billed reimbursable expenses.
Selling, general and administrative expenses— For the ninethree months ended September 30, 2017,March 31, 2022, selling, general and administrative expense was $135.9expenses were $30.0 million compared to $50.1$34.1 million for the ninethree months ended September 30, 2016, an increaseMarch 31, 2021, a decrease of $85.9$4.0 million, or 171%12%. This increasedecrease was primarily the result of an increase of approximately $27.9a $3.5 million decrease in professional fees and support costs during the nine months ended September 30, 2017, including theand a $1.2 million decrease in wages and employee benefit costs associated with increasing headcount and preparing for the commercialization of TYMLOSdue to a decrease in the United States. This increase was also drivenheadcount. These decreases were offset by a $49.4$0.7 million increase in compensation expense, including stock-based compensation, due to an increase in headcount from 90 generaloccupancy and administrative employees as of September 30, 2016 to 65 generaldepreciation costs and administrative employees and 296 selling related personnel as of September 30, 2017.other operating costs.
InterestOther income (expense), net—For the ninethree months ended September 30, 2017,March 31, 2022, other income, net of expense was $0.4 million, as compared to other expense, net of other income of $1.0 thousand during the three months ended March 31, 2021. Other expense, net of other income, of $379.0 thousand for the three months ended March 31, 2022 consisted primarily of other taxes and foreign currency revaluation gains.
Interest income— For the three months ended March 31, 2022, interest income was approximately $2.0 million$14.0 thousand compared to $2.0 million$57.0 thousand for the ninethree months ended September 30, 2016,March 31, 2021, a decrease of $13.0$43.0 thousand, or 1%75%. This decrease was primarily due to the combined effects of a decrease in the balance of our investments coupled with an increase incash equivalents, which were used to fund operations.
Interest expense— For the rate of return on investments in the ninethree months ended September 30, 2017 as compared to those of the nine months ended September 30, 2016.
Interest expense—For the nine months ended September 30, 2017,March 31, 2022, interest expense was approximately $2.8$4.8 million compared to $0$4.4 million for the ninethree months ended September 30, 2016,March 31, 2021, an increase of $2.8$0.5 million, or 100%10%. This increase was the result ofdriven the issuance of the new term loan in March 2021 which resulted in a $2.1 million increase in interest. This increase was partially offset by a $0.8 million decrease in interest expense as a result of the repurchase of $112.2 million face amount of the 3% Convertible Senior Notes duringin March 2021.
Gain on extinguishment of debt— For the ninethree months ended September 30, 2017, while there was noMarch 31, 2021, we recognized a gain on the extinguishment of debt outstanding forof $2.0 million related to the nine months ended September 30, 2016.repurchase of a portion of our Convertible Notes.
Liquidity and Capital Resources
From inception to September 30, 2017,March 31, 2022, we have incurred an accumulated deficit of $811.3$1,386.3 million, primarily as a result of expenses incurred through a combination of research and development activities related to our various product candidates and expenses supporting those activities. Our total cash and cash equivalents and short-term marketable securities balance as of September 30, 2017March 31, 2022 was $468.1$71.6 million. We have historically financed our operations since inception primarily through the public offerings of our common stock, issuance of convertible debt, private sales of preferred stock, and borrowings under credit facilities, and followingfacilities. Following our U.S. commercial launch of TYMLOS in the United States,May 2017, we have recently begun financingfinanced a portion of our operations through product revenue.
Based upon our cash and cash equivalents balance as of March 31, 2022 and marketable securities balance,funds available to us through our credit facilities, we believe that, prior to the consideration of potential proceeds from partnering and/or collaboration activities, we have sufficient capital to fund our development plans and our U.S. commercial and other operational activities for not less thanat least twelve months from the date of this filing. We expect to finance the future U.S. commercial activities and development costs of our clinical product portfolio with our existing cash and cash equivalents, and marketable securities,as well as through future product sales, or through strategic financing opportunities, that could include, but are not limited to partnering or other collaboration agreements, future offerings of equity, royalty-based financing arrangements, or the incurrence of additional debt, or other alternative financing arrangements. arrangements, which may involve a combination of the foregoing.
There is no guarantee that any of thesestrategic or financing opportunitiesopportunity will be available to usexecuted or executed on favorable terms, and some could be dilutive to existing stockholders. Our future capital requirements will depend on many factors, including the scope of and progress made in our research and development and commercialization activities, the results of our clinical trials, and the review and potential approval of our products by the FDA and the EMA.or other foreign regulatory authorities. The successful development of our investigational product candidates is subject to numerous risks and uncertainties associated with commercializing and developing drugs, which could have a significant impact on the cost and timing associated with the commercialization and development of our products
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and product candidates. If we fail to obtain additional future capital, we may be unable to complete our planned commercialization activities or complete preclinical and clinical trials and obtain approval of any investigationalof our product candidates from the FDA andor foreign regulatory authorities.
TYMLOS is our only approved product and our business currently depends heavily on its continued successful commercialization. Successful commercialization of an approved product is an expensive and uncertain process. See “Risk Factors - Risks Related to the Discovery,Commercialization and Development and Commercialization of Our Product Candidates” set forth under Itemin Part I, “Item 1A.

Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2021.
The following table sets forth the major sources and uses of cash for each of the periods set forth below (in thousands):
Nine Months Ended     Three Months Ended  
September 30, Change March 31,Change
2017 2016 $ % 20222021$%
Net cash (used in) provided by: 
  
  
  
Net cash (used in) provided by:    
Operating activities$(167,091) $(103,074) $(64,017) (62)%Operating activities$(40,243)$(19,113)$(21,130)(111)%
Investing activities41,105
 139,519
 (98,414) (71)%Investing activities(157)23,240 (23,397)(101)%
Financing activities314,357
 2,442
 311,915
 12,773 %Financing activities482 18,561 (18,079)(97)%
Net decrease in cash and cash equivalents$188,371
 $38,887
 149,484
 384 %
Net increase in cash, cash equivalents, and restricted cashNet increase in cash, cash equivalents, and restricted cash$(39,918)$22,688 $(62,606)(276)%
Cash Flows from Operating Activities
Net cash used in operating activities during the ninethree months ended September 30, 2017March 31, 2022 was $167.1$40.2 million, which was primarily the result of a net loss of $183.2$18.3 million, partially offset by $31.6$4.9 million of net non-cash adjustments to reconcile net loss to net cash used in operations and net changes in working capital of $14.8$26.9 million. The $183.2$18.3 million net loss was primarily due to abaloparatide-SC program costs, abaloparatide-TD program costs, elacestrant and elacestrantRAD011 program development expenses along with employee compensation and consulting costs incurred to support regulatory submissions and preparation for the commercial launchcommercialization of TYMLOS in the United States. The $31.6$4.9 million net non-cash adjustments to reconcile net loss to net cash used in operations primarily included stock-basedshare-based compensation expense of $28.8$4.1 million, depreciation of $0.4 million and amortization of debt discountdiscounts of $1.6 million, and depreciation of $1.4$0.4 million.
Net cash used in operating activities during the ninethree months ended September 30, 2016March 31, 2021 was $103.1$19.1 million, which was primarily the result of a net loss of $130.1$15.7 million, partially offset by $19.9$4.1 million of net non-cash adjustments to reconcile net loss to net cash used in operations and net changes in working capital of $6.6$7.4 million. The $130.1$15.7 million net loss was primarily due to abaloparatide-SC program costs, abaloparatide-TD program costs, elacestrant and RAD011 program development expenses including clinical and manufacturing costs, along with employee compensation and consulting costs incurred to support regulatory submissions and preparation for the commercial launchcommercialization of TYMLOS in the United States. The $19.9$4.1 million net non-cash adjustments to reconcile net loss to net cash used in operations primarily included stock-basedshare-based compensation expense of $18.7$5.4 million, amortizationdepreciation of premiums on marketable securities of $0.8$0.3 million and depreciationother non-cash adjustments offset by gain on extinguishment of $0.4debt of $2.0 million.
Cash Flows from Investing Activities
Net cash provided byused in investing activities during the ninethree months ended September 30, 2017March 31, 2022 was $41.1$0.2 million, which was primarily the result of $117.4 millionthe purchase of purchases of marketable securitiesproperty and $8.7 million payments for capitalized milestones. These activities were partially offset by $170.2 million of net proceeds received from the sale or maturity of marketable securities.equipment.
Net cash provided by investing activities during the ninethree months ended September 30, 2016March 31, 2021 was $139.5$23.2 million, which was primarily the result of $367.1 million of net proceeds received from the sale or maturitysales and maturities of marketable securities partially offset by $225.5 million of purchases of marketable securities.
Our investing cash flows will be impacted by the timing of purchases and sales of marketable securities. Because our marketable securities are primarily short-term in duration, we would not expect our operational results or cash flows to be significantly affected by a change in market interest rates.
Cash Flows from Financing Activities
Net cash provided by financing activities during the ninethree months ended September 30, 2017March 31, 2022 was $314.4$0.5 million, which primarily consisted of $295.6 million of proceeds from our 3% Convertible Senior Notes due 2024, $16.2 million of proceeds received from exercises of stock options and $2.6 millioncash received upon issuance of common stock under the Radius Health, Inc. 2016 Employee Stock Purchase Plan.Plan (“ESPP”).
Net cash provided by financing activities during the ninethree months ended September 30, 2016March 31, 2021 was $18.6 million, which consisted of $2.4$122.7 million of proceeds received from issuance of the exerciseterm loan, $3.8 million of proceeds received from exercises of stock options.options, and $0.7 million received upon issuance of common stock under the ESPP. These proceeds were offset by the use of $108.6 million to repurchase convertible notes.
Borrowings and Other Liabilities

There were no material changes in borrowing arrangements and equity offerings since the filing of our most recent Annual Report.
In August 2017,Contractual Obligations and Commitments
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Contractual obligations represent future cash commitments and liabilities under agreements with third parties and exclude contingent liabilities for which we issued $300.0 million aggregate principal amountcannot reasonably predict future payment. We enter into contracts in the normal course of Convertible Notes, as discussed in more detail in Note 15, “Convertible Notes Payable,” to our condensed consolidated financial statementsbusiness for marketing and promotion, commercial activities, preclinical and clinical research studies, research supplies, and other services and products for operating purposes. These contracts generally provide for termination on notice, and therefore are cancellable contracts and not included in this Quarterlythe table of contractual obligations and commitments. We are also a party to certain material supply, manufacturing, license and other agreements entered into outside of the normal course of our business, as more fully described in our Annual Report on Form 10-Q. We received net proceeds of approximately $290.8 million from10-K for the sale of the Convertible Notes, after deducting fees and expenses of $9.2 million. In addition, on September 12, 2017, we issued an additional $5.0 million aggregate principal amount of the Convertible Notes pursuant to the exercise of an over-allotment option granted to the underwriters in the offering. We received net proceeds of approximately $4.8 million from the sale of the over-allotment option, after deducting fees and expenses of $0.2 million.
Future minimum payments on our long-term debt as of September 30, 2017 were as follows (in thousands):
Years ended December 31,Future Minimum Payments
2017$
20189,582
20199,150
20209,150
20219,150
2022 and Thereafter$332,450
Total minimum payments$369,482
Less: interest(64,482)
Less: unamortized discount(142,241)
Less: current portion
Long Term Debt$162,759
Contractual Obligations
Supply and Manufacturing Agreements
In June 2016, we entered into a supply agreement with Ypsomed AG ("Ypsomed"), pursuant to which Ypsomed agreed to supply commercial and clinical supplies of a disposable pen injection device ("Device"), customized for subcutaneous injection of TYMLOS. We agreed to purchase a minimum number of Devices at prices per Device that decrease with an increase in quantity supplied. year ended December 31, 2021.In addition, we agreedhave certain obligations to make 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 has an initial term of three years from the earlier of the date of delivery of the first commercial Devices for regulatory approval and June 1, 2017, after which, it automatically renews for two-year terms until terminated. During the initial term of the agreement, we estimate that we will be obligated to make total minimumfuture payments to Ypsomed of approximately CHF 3.9 million ($4.0 million) in the aggregate, including the milestone paymentsthird parties that become due and one-time capacity fee.
In June 2016, we entered into a commercial supply agreement with Vetter Pharma International, GmbH ("Vetter"), pursuant to which Vetter agreed to formulate the finished TYMLOS drug product containing the active pharmaceutical ingredient ("API"), of TYMLOS, to fill cartridges with the drug product, to assemble the pen delivery device, and to package and label the pen for commercial distribution. We agreed to purchase the cartridges and pens in specified batch sizes at a price per unit. For labeling and packaging services, we agreed to pay a per unit price dependent upon the number of pens loaded with cartridges that are labeled and packaged. These prices are subject to an annual price adjustment. The agreement has an initial term of five years, which beganpayable on January 1, 2016, after which, it automatically renews for two-year terms unless either party provides notice of non-renewal two years before the end of the then-current term. There are no minimum purchase requirements under the terms of this contract.
In July 2016, we entered into a manufacturing services agreement with Polypeptide Laboratories Holding AB ("PPL"), as successor-in-interest to Lonza Group Ltd., pursuant to which PPL agreed to manufacture the commercial and clinical supplies of the API for TYMLOS. We agreed to purchase the API in batches at a price per gram in euros, subject to an annual increase by PPL. We also agreed to purchase a minimum number of batches annually. The agreement has an initial term of a six years, 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.
Research and Development Agreements

Abaloparatide-SC Phase 3 Clinical Trial
In February 2013, we contracted with Nordic Bioscience Clinical Development VII A/S ("Nordic"), to conduct our Phase 3 clinical trial of abaloparatide-SC, or the Phase 3 Clinical Trial. Nordic also agreed to perform an extension study to evaluate six months of standard-of-care osteoporosis management following the completion of the Phase 3 Clinical Trial ("Extension Study"), and, upon completion of this initial six months, an additional period of 18 months of standard-of-care osteoporosis management ("Second Extension").
In April 2015, we contracted with Nordic to perform additional services, including monitoring of patients enrolled in the Second Extension. Payments in cash to be made to Nordic for these additional services are denominated in euro and total up to approximately €4.1 million (approximately $4.3 million).
Payments in cash to be made to Nordic for the services related to the Extension Study and the Second Extension are denominated in both euros and U.S. dollars and total up to €11.9 million (approximately $12.5 million) and $1.1 million, respectively. As of December 31, 2016, the last patient's final visit in the Second Extension had occurred and all obligations due to Nordic in relation to the Extension Study have been paid.
License Agreement Obligations
TYMLOS (abaloparatide)
In September 2005, we entered into a license agreement with Ipsen, as amended, or the License Agreement, under which we exclusively licensed certain Ipsen compound technology and related patents covering abaloparatide to research, develop, manufacture and commercialize certain compounds and related products in all countries, except Japan (where we have an option to negotiate a co-promotion agreement for abaloparatide-SC with Teijin) and France (where our commercialization rights were subject to certain co-marketing and co-promotion rights exercisable by Ipsen, provided that certain conditions included in the License Agreement were met). We believe that Ipsen's co-marketing and co-promotion rights in France have permanently expired. Ipsen also granted us an exclusive right and license under the Ipsen compound technology and related patents to make and have made compounds or product in Japan. Ipsen further granted us an exclusive right and license under certain Ipsen formulation technology and related patents solely for purposes of enabling us to develop, manufacture and commercialize compounds and products covered by the compound technology license in all countries, except Japan and France (as discussed above).
In consideration for the rights to abaloparatide and in recognition of certain milestones having been met to date, we have paid to Ipsen an aggregate amount of $13.0 million. The License Agreement further requires us to make payments upon the achievement of certain futuredevelopment, regulatory and commercial milestones. Total additional milestonemilestones, such as the start of a clinical trial, filing of an NDA, approval by the FDA, or product launch. The disclosed balances exclude the potential payments that couldwe may be payablerequired to make under our agreements because the agreementtiming of payments and actual amounts paid under those agreements may be different depending on the timing of receipt of goods or services or changes to agreed-upon terms or amounts for some obligations, and those agreements are €24.0 million (approximately $28.4 million). In connection withcancellable upon written notice by us and therefore, not long-term liabilities. Additionally, the FDA's approvalexpected timing of TYMLOS in April 2017, we paid Ipsen a milestone of €8.0 million (approximately $8.7 million) under the License Agreement, which we have recorded as an intangible asset and will amortize over the remaining patent life or the estimated useful lifepayment of the underlying product, whicheverobligations presented below is shorter. The agreement also provides that we will pay to Ipsen a fixed five percent royaltyestimated based on net salescurrent information.
During the three months ended March 31, 2022, there were no material changes to our contractual obligations described under “Management’s Discussion and Analysis of the product by us orFinancial Condition and Results of Operations” included in our sublicenseesAnnual Report on a country-by-country basis until the later of the last to expire of the licensed patents or for a period of 10 years after the first commercial sale in such country. The date of the last to expire of the abaloparatide patents licensed from or co-owned with Ipsen, barring any extension thereof, is expected to be March 26, 2028.
If we sublicense abaloparatide to a third party, the agreement provides that we would pay a percentage of certain payments received from such sublicensee (in lieu of milestone payments not achieved at the time of such sublicense). The applicable percentage is in the low double-digit range. In addition, if we or our sublicensees commercialize a product that includes a compound discovered by us based on or derived from confidential Ipsen know-how, the agreement provides that we would pay to Ipsen a fixed low single digit royalty on net sales of such product on a country-by-country basis until the later of the last to expire of our patents that cover such product or for a period of 10 years after the first commercial sale of such product in such country.
The License Agreement expires on a country-by-country basis on the later of (1) the date the last remaining valid claim in the licensed patents expires in that country, or (2) a period of 10 years after the first commercial sale of the licensed products in such country, unless it is sooner terminated in accordance with its terms.
Prior to executing the License Agreement for abaloparatide with Radius, Ipsen licensed the Japanese rights for abaloparatide to Teijin. Teijin has initiated a Phase 3 clinical study of abaloparatide-SC in JapanForm 10-K for the treatment of postmenopausal osteoporosis. We have an option to negotiate a co-promotion agreement with Teijin for abaloparatide-SC in Japan and we maintain full global rights to our development program for abaloparatide-TD.

We are currently in arbitration proceedings with Ipsen in connection with the License Agreement. See “Legal Proceedings” for more information.
Elacestrant (RAD1901)
In June 2006, we entered into a license agreement ("Eisai Agreement"), with Eisai Co. Ltd. ("Eisai"). Under the Eisai Agreement, Eisai granted to us an exclusive right and license to research, develop, manufacture and commercialize elacestrant (RAD1901) and related products from Eisai in all countries, except Japan. In consideration for the rights to elacestrant, we paid Eisai an initial license fee of $0.5 million, which was expensed during 2006. In March 2015, we entered into an amendment to the Eisai Agreement, or the "Eisai Amendment," in which Eisai granted to us the exclusive right and license to research, develop, manufacture and commercialize elacestrant in Japan. In consideration for the rights to elacestrant in Japan, we paid Eisai an initial license fee of $0.4 million upon execution of the Eisai Amendment, which was recognized as research and development expense in 2015. The Eisai Amendment, as amended, also provides for additional payments of up to $22.3 million, payable upon the achievement of certain future clinical and regulatory milestones.
Under the Eisai Agreement, as amended, should a product covered by the licensed technology be commercialized, we will be obligated to pay to Eisai royalties in a variable mid-single digit range based on net sales of the product on a country-by-country basis. The royalty rate will be reduced, on a country-by-country basis, at such time as the last remaining valid claim in the licensed patents expires, lapses or is invalidated and the product is not covered by data protection clauses. In addition, the royalty rate will be reduced, on a country-by-country basis, if, in addition to the conditions specified in the previous sentence, sales of lawful generic versions of such product account for more than a specified minimum percentage of the total sales of all products that contain the licensed compound during a calendar quarter. The latest licensed patent is expected to expire, barring any extension thereof, on August 18, 2026.
The Eisai Agreement, as amended, also grants us the right to grant sublicenses with prior written approval from Eisai. If we sublicense the licensed technology to a third party, we will be obligated to pay Eisai, in addition to the milestones referenced above, a fixed low double-digit percentage of certain fees received from such sublicensee and royalties in the low single digit range based on net sales of the sublicensee. The Eisai Agreement expires on a country-by-country basis on the later of (1) the date the last remaining valid claim in the licensed patents expires, lapses or is invalidated in that country, the product is not covered by data protection clauses, and the sales of lawful generic versions of the product account for more than a specified percentage of the total sales of all pharmaceutical products containing the licensed compound in that country; or (2) a period of 10 years after the first commercial sale of the licensed products in such country, unless it is sooner terminated.
Teijin Limited
In July 2017, we entered into a license and development agreement with Teijin for abaloparatide-SC in Japan. Teijin is developing abaloparatide-SC in Japan under an agreement with Ipsen and has initiated a Phase 3 trial in Japanese patients with osteoporosis. Pursuant to the Teijin Agreement, we granted Teijin (i) an exclusive payment bearing license under certain of our intellectual property to develop and commercialize abaloparatide-SC in Japan, (ii) a non-exclusive payment bearing license under certain of our intellectual property to manufacture abaloparatide-SC for commercial supply in Japan, (iii) a right of reference to certain of our 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) an obligation, at Teijin’s request, to 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) an obligation, at Teijin’s request, to 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, we received an upfront payment of $10.0 million. The Teijin Agreement also provides for additional payments to us of up to an aggregate of $40.0 million upon the achievement of certain regulatory and sales milestones, and requires Teijin to pay us a fixed low double-digit royalty based on net sales of abaloparatide-SC in Japan during the royalty term, as defined below.In addition, we have an option to negotiate a co-promotion agreement with Teijin for abaloparatide-SC in Japan.
Teijin granted us (i) an exclusive license under certain of Teijin’s intellectual property to develop, manufacture and commercialize abaloparatide-SC outside Japan and (ii) a right of reference to certain of Teijin’s regulatory data related to abaloparatide-SC for purposes of developing, manufacturing and commercializing abaloparatide-SC outside Japan. We maintain full global rights to its development program for abaloparatide-TD, which is not part of the Teijin Agreement. Pursuant to the Teijin Agreement, the parties may further collaborate on new indications for abaloparatide-SC.

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 our 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.year ended December 31, 2021.
Net Operating Loss Carryforwards
As of December 31, 2016,2021, we had federal and state net operating loss carryforwards of approximately $526.7$1,033.8 million and $385.3$710.5 million, respectively, subject to limitation, as described below. If not utilized, the net operating loss carryforwards will expire at various dates through 2036.
Under Section 382 of the Internal Revenue Code of 1986, or Section 382, substantial changes in our ownership may limit the amount of net operating loss carryforwards that could be used annually in the future to offset taxable income. We have completed studies through December 31, 2015,February 28, 2022, to determine whether any ownership change has occurred since our formation and have determined that transactions have resulted in two ownership changes, as defined under Section 382. There could be additional ownership changes and/or in the future that could further limit the amount of net operating loss and tax credit carryforwards that we can utilize.
A full valuation allowance has been recorded against our net operating loss carryforwards and other deferred tax assets, as the realization of the deferred tax asset is uncertain.
As a result, we have not recorded any federal or state income tax benefit in our statementcondensed consolidated statements of operations.
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements or any relationships with unconsolidated entities of financial partnerships, such as entities often referred to as structured finance or special purpose entities.
New Accounting Standards
See Note 2 - Basis of Presentation and Significant Accounting Policies - Accounting Standards Updates in the accompanying unaudited condensed consolidated financial statements in this Quarterly Report on Form 10-Q for a discussion of new accounting standards.

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Item 3.Quantitative and Qualitative Disclosures about Market Risk.
We are exposed to market risk related to changes in the dollar/euro and dollar/Swiss franc exchange ratesrate because a portion of our development and costs of goods expenses are denominated in foreign currencies.euros. We do not hedge our foreign currency exchange rate risk. However, an immediate 10%10 percent adverse change in the dollar/euro or dollar/Swiss Franc exchange rate would not have a material effect on our financial results.
We are exposed to market risk related to changes in interest rates. As of September 30, 2017,March 31, 2022, we had cash, cash equivalents, and short-term marketable securitiesrestricted cash of $468.1 million, consisting of cash, money market funds, domestic corporate debt securities, domestic corporate commercial paper, and asset-backed securities.$72.2 million. This exposure to market risk is interest rate sensitivity, which is affected by changes in the general level of U.S. interest rates, particularly because our investments are in marketable securities. Because our marketable securities are short-term in duration, and have a low risk profile, an immediate 10% change in interest rates would not have a material effect on the fair market value of our portfolio. We generally have the ability to hold our investments until maturity, and therefore we would not expect our operating results or cash flows to be affected to any significant degree by a change in market interest rates on our investments. We carry our investments based on publicly available information.rates. As of September 30, 2017,March 31, 2022, we dodid not have any hard-to-value investment securities or securities for which a market is not readily available or active.
We are also exposed to interest rate volatility with regard to existing debt issuances. As of March 31, 2022, we had a term loan balance of $148.5 million and borrowings under this 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% and 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%. An immediate 10% change in interest rates would not have a material effect on the fair value of our term loan, and would not have a significant impact on our financial statements as we do not record debt at fair value.
We are not subject to significant credit risk as this risk does not have the potential to materially impact the value of our assets and liabilities.




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Table of Contents
Item 4.Controls and Procedures.
Disclosure Controls and Procedures
Our management, with the participation of our principal executive officer and principal financial officer, evaluated the effectiveness of our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, as of the end of the period covered by this Quarterly Report on Form 10-Q. Based on this evaluation, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures were effective as of September 30, 2017.March 31, 2022.
Changes in Internal Control over Financial Reporting
We consider the accounting for our net product revenue from sales of TYMLOSThere was no change in the United States to be material to the results of operations for the three months ended September 30, 2017, and believe that the additional internal controls and procedures relating to the accounting for net product revenues, as well as adoption of Topic 606 in connection therewith, and related commercial inventory, have a material effect on our internal control over financial reporting. Duringreporting during the quarterthree months ended September 30, 2017, there were no further changes inMarch 31, 2022 that has materially affected, or is reasonably likely to materially affect, our internal controlscontrol over financial reporting. See Note 2, "Basis


29

Table of Presentation and Significant Accounting Policies" to our unaudited condensed consolidated financial statements contained in this Quarterly Report on Form 10-Q for further details.Contents

PART II— OTHER INFORMATION
Item 1.Legal Proceedings.
In November 2016,From time to time, we received notice that in October 2016, Ipsen had initiated arbitration proceedings against usare party to litigation arising in the International Chamberordinary course of Commerce’s International Courtour business. As of Arbitration. Ipsen’s Request for Arbitration alleged thatMarch 31, 2022, we breached various provisions of the License Agreement concerning abaloparatide, including with regardwere not party to Ipsen's right to co-promote abaloparatide in France and a license from us with respect to Japan. Ipsen is seeking declaratory relief, compliance with the License Agreement, damages, costs and fees as a result of the purported breaches, and has alleged the monetary value of these claims is approximately €50 million.any significant litigation.
In January 2017, we submitted an Answer denying Ipsen’s claims and alleging counterclaims against Ipsen for breach of the License Agreement and other declaratory judgment. We asserted, among other things, that Ipsen's claimed rights to co-promote abaloparatide in France and to a license from us with respect to Japan have permanently expired, and that Ipsen has breached the License Agreement by, among other things, allowing certain patents to expire and by purporting to license to a third party certain manufacturing and other rights that we contend Ipsen exclusively licensed to us. We are seeking dismissal of Ipsen’s claims, as well as declaratory relief, compliance with the License Agreement, and other damages, costs and fees to be determined by the Arbitral Tribunal.
In February 2017, Ipsen submitted a Reply denying our counterclaims and alleging that we are precluded from asserting them. Following a preliminary hearing before the Arbitral Tribunal to determine certain jurisdictional and contractual defenses asserted by Ipsen in its Reply, on July 17, 2017, the Arbitral Tribunal issued a decision finding it has jurisdiction to decide our counterclaims and that our counterclaims are not contractually barred.
On July 31, 2017, Ipsen submitted its Statement of Claim to the Arbitral Tribunal and on September 14, 2017 Radius submitted its Statement of Defense and Counterclaims. Subsequently, on October 20, 2017, Ipsen submitted its Reply and Statement of Defense to Radius’s Counterclaims to the Arbitral Tribunal. The arbitration proceeding is continuing and following additional briefing a hearing on the merits is anticipated to be held in December 2017. Given that this matter is at a preliminary stage, we cannot predict or assess the likely outcome of these proceedings.
Item 1A.Risk Factors.
Our business faces significant risks and uncertainties. Certain important factors may have a material adverse effect on our business prospects, financial condition and results of operations, and you should carefully consider them. Accordingly, in evaluating our business, we encourage you to carefully consider the discussion of risk factors in Part II,I, “Item 1A. Risk Factors” in our QuarterlyAnnual Report on Form 10-Q10-K for the quarteryear ended June 30, 2017,December 31, 2021, which could materially affect our business, financial condition or future results, in addition to other information contained in or incorporated by reference into this Quarterly Report on Form 10-Q and our other public filings with the SecuritiesSEC.

The Company reviewed its risk factors as of March 31, 2022 and Exchange Commission, ordetermined that there were no material changes from the SEC.ones set forth in its Annual Report on Form 10-K for the year ended December 31, 2021.



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Item 2.Unregistered Sales of Equity Securities and Use of Proceeds.
None.

Item 3.Defaults Upon Senior Securities.
None.

Item 4.Mine Safety Disclosures.
None.

Item 5.Other Information.
None.

Item 6.Exhibits.
A list of exhibits is set forth onin the Exhibit Index immediately following the signature page of this Quarterly Report on Form 10-Q, andbelow, which is incorporated herein by reference.

31


EXHIBIT INDEX
Unless otherwise indicated, all references to previously filed Exhibits refer to the Company’s filings with the Securities and Exchange Commission, under File No. 001-35726.
  Incorporated by ReferenceFiled/
Exhibit    FilingFurnished
NumberExhibit DescriptionFormFile No.ExhibitDateHerewith
Restated Certificate of Incorporation8-K001-357263.16/13/2014
Amended and Restated By-Laws8-K001-357263.29/27/2021
Offer Letter between the Company and Mark Conley8-K001-3572610.13/16/2022
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.SCHInline XBRL Taxonomy Extension Schema Document*
101.CALInline XBRL Taxonomy Extension Calculation Linkbase Document*
101.LABInline XBRL Taxonomy Extension Label Linkbase Document*
101.PREInline XBRL Taxonomy Extension Presentation Linkbase Document*
101.DEFInline 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.*)         *
*Filed herewith.
**Furnished herewith.

SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
 
 
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RADIUS HEALTH, INC.
By:/s/ Jesper Høiland
Jesper Høiland

President and Chief Executive Officer
(Principal Executive Officer)
Date: November 2, 2017
By:/s/ Jose Carmona
Jose Carmona
Chief Financial Officer
(Principal Accounting and Financial Officer)
Date: November 2, 2017


EXHIBIT INDEX
    Incorporated by Reference Filed/
Exhibit         Filing Furnished
Number Exhibit Description Form File No. Exhibit Date Herewith
             
 Restated Certificate of Incorporation, filed on June 11, 2014 8-K 001-35726 3.1 6/13/2014  
             
 Amended and Restated By-Laws 8-K 001-35726 3.2 6/13/2014  
             
10.1
 License and Development Agreement, dated July 13, 2017, between the Company and Teijin Limited         *
             
 Agreement and General Release, dated July 16, 2017, between the Company and Robert Ward 8-K 001-35726 10.3 7/17/2017  
             
 Employment Inducement Stock Option Agreement, dated July 17, 2017, between the Company and Jesper Høiland 8-K 001-35726 10.2 7/17/2017  
             
 Amended and Restated First Amendment to Sublease, dated August 1, 2017, between the Company and Rovi Corporation         *
             
 Certification of Chief Executive Officer pursuant to Exchange Act Rule 13a-14(a)/15d-14(a)         *
             
 Certification of Chief Financial Officer pursuant to Exchange Act Rule 13a-14(a)/15d-14(a)         *
             
 Certification of Chief Executive Officer and Chief Financial Officer Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002         **
             
101.INS XBRL Instance Document         *
             
101.SCH XBRL Taxonomy Extension Schema Document         *
             
101.CAL XBRL Taxonomy Extension Calculation Linkbase Document         *
             
101.DEF XBRL Taxonomy Extension Definition Linkbase Document         *
             
101.LAB XBRL Taxonomy Extension Label Linkbase Document         *
             
101.PRE XBRL Taxonomy Extension Presentation Linkbase Document         *
             

RADIUS HEALTH, INC.
By:/s/ G. Kelly Martin
G. Kelly Martin
President and Chief Executive Officer
(Principal Executive Officer)
Date: May 5, 2022
By:/s/ Mark W. Conley
Mark W. Conley
Vice President and Chief Financial Officer
(Principal Accounting and Financial Officer)
Date: May 5, 2022
*Filed herewith.
**Furnished herewith.
† Confidential treatment has been requested with respect to certain portions of this exhibit, which portions have been filed separately with the Securities and Exchange Commission.



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