rdus-20210331

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended March 31, 2021

☐ TRANSITION 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)


Delaware						80-0145732
(State or other jurisdiction of						(IRS Employer
Incorporation or organization)						Identification Number)

22 Boston Wharf Road, 7th Floor

Boston, Massachusetts 02210

(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 class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, $0.0001 par value per share	RDUS	The 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 ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted 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 such files). Yes ☒ No ☐

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 growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer

☒

Accelerated filer

☐

Non-accelerated filer

☐

Smaller reporting company

☐

Emerging growth company

☐

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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. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

Number of shares of the registrant’s Common Stock, $0.0001 par value per share, outstanding as of May 3, 2021: 47,242,659 shares

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RADIUS HEALTH, INC.

FORM 10-Q

FOR THE QUARTER ENDED MARCH 31, 2021

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PART I FINANCIAL INFORMATION

Item 1.	Condensed Consolidated Financial Statements (Unaudited)	4
	Condensed Consolidated Balance Sheets as of March 31, 202 1 and December 31, 2 020	4
	Condensed Consolidated Statements of Operations and Comprehensive Loss for the three months ended March 31 , 202 1 and 20 20	5
	Condensed Consolidated Statements of Cash Flows for the three months ended March 31 , 202 1 and 20 20	6
	Condensed Consolidated Statements of Stockholders’ Equity (Deficit) for the three months ended March 31 , 202 1 and 20 20	7
	Notes to Condensed Consolidated Financial Statements	8
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	20
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	33
Item 4.	Controls and Procedures	34

PART II OTHER INFORMATION		35

Item 1.	Legal Proceedings	35
Item 1A.	Risk Factors	35
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	36
Item 3.	Defaults Upon Senior Securities	36
Item 4.	Mine Safety Disclosures	36
Item 5.	Other Information	36
Item 6.	Exhibits	36

SIGNATURES		38

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PART I— FINANCIAL INFORMATION

Item 1. Condensed Consolidated Financial Statements

Radius Health, Inc.

Condensed Consolidated Balance Sheets

(Unaudited, in thousands, except share and per share amounts)


	March 31, 2021		December 31, 2020
	(unaudited)
ASSETS
Current assets:
Cash and cash equivalents	$	114,124	$	91,436
Restricted cash	567		567
Marketable securities	—		23,280
Accounts receivable, net	26,305		20,310
Inventory	9,430		9,174
Prepaid expenses	14,291		13,279
Other current assets	29,967		22,502
Total current assets	194,684		180,548

Property and equipment, net	745		796
Intangible assets	5,585		5,785
Right of use assets - operating leases	3,575		3,933
Other assets	520		520
Total assets	$	205,109	$	191,582

LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
Current liabilities:
Accounts payable	$	7,782	$	9,925
Accrued expenses and other current liabilities	70,452		59,758
Deferred revenue	—		1,000
Operating lease liability, current	2,165		2,490
Total current liabilities	80,399		73,173
Convertible notes payable	189,859		213,645
Term loan	147,640		24,905
Operating lease liability, long term	3,221		3,518
Total liabilities	421,119		315,241

Stockholders’ equity (deficit):
Common stock, 0.0001 par value; 200,000,000 shares authorized, 47,241,098 shares and 46,779,479 shares issued and outstanding at March 31, 2021 and December 31, 2020	5		5
Additional paid-in-capital	1,097,539		1,222,137
Accumulated other comprehensive income	—		21
Accumulated deficit	(1,313,554)		(1,345,822)
Total stockholders’ equity (deficit)	(216,010)		(123,659)
Total liabilities and stockholders’ equity (deficit)	$	205,109	$	191,582

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,
	2021		2020
REVENUES:
Product revenue, net	$	45,261	$	47,923
License revenue	11,000		—
Total revenue	$	56,261	$	47,923
OPERATING EXPENSES:
Cost of sales - product	3,925		3,861
Cost of sales - intangible amortization	200		200
Research and development, net of amounts reimbursable (a)	31,440		39,009
Selling, general and administrative	34,097		36,433

Income (Loss) from operations	(13,401)		(31,580)
OTHER INCOME (EXPENSE):
Other (expense) income	(1)		11
Interest expense	(4,364)		(6,756)
Interest income	57		671
Gain on extinguishment of debt	1,960		—
NET LOSS	$	(15,749)	$	(37,654)
OTHER COMPREHENSIVE LOSS:
Unrealized loss from available-for-sale debt securities	(21)		(669)
COMPREHENSIVE LOSS	$	(15,770)	$	(38,323)
LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS - BASIC AND DILUTED (Note 8)	$	(15,749)	$	(37,654)
LOSS PER SHARE:
Basic and diluted	$	(0.34)	$	(0.81)

WEIGHTED AVERAGE SHARES:
Basic and diluted	46,981,016		46,271,123

(a) Amounts reimbursable were $14.3 million and $0 for the three ended March 31, 2021 and 2020, respectively.

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)


	Three Months Ended March 31,
	2021		2020
CASH FLOWS USED IN OPERATING ACTIVITIES:
Net loss	$	(15,749)	$	(37,654)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	251		492
Amortization of premium/discount on marketable securities, net	19		(4)
Amortization of debt discount and debt issuance costs	358		4,289


Stock-based compensation	5,410		5,459

Gain on extinguishment of debt	(1,960)		—
Changes in operating assets and liabilities:
Inventory	(256)		(679)
Accounts receivable, net	(5,995)		(7,082)
Prepaid expenses	(1,012)		2,887
Other current assets	(7,465)		(368)
Operating lease right of use assets	358		510

Accounts payable	(2,143)		3,162
Deferred revenue	(1,000)		—
Accrued expenses and other current liabilities	10,693		(3,619)
Lease liability, operating leases	(622)		(578)

Net cash used in operating activities	(19,113)		(33,185)
CASH FLOWS PROVIDED BY INVESTING ACTIVITIES:


Purchases of marketable securities	—		(39,907)
Sales and maturities of marketable securities	23,240		33,000
Net cash provided by (used in) investing activities	23,240		(6,907)
CASH FLOWS PROVIDED BY FINANCING ACTIVITIES:
Proceeds from exercise of stock options and warrant exercises	3,764		—

Proceeds from issuance of term loan, net of issuance costs	122,687		9,939


Repurchase of convertible notes	(108,568)		—
Proceeds from issuance of shares under employee stock purchase plan	678		990
Net cash provided by financing activities	18,561		10,929
NET INCREASE IN CASH, CASH EQUIVALENTS, AND RESTRICTED CASH	22,688		(29,163)
CASH, CASH EQUIVALENTS, AND RESTRICTED CASH AT BEGINNING OF PERIOD	92,003		70,453
CASH, CASH EQUIVALENTS, AND RESTRICTED CASH AT END OF PERIOD	$	114,691	$	41,290
SUPPLEMENTAL DISCLOSURES:
Cash paid for interest	$	4,936	$	4,685

Cash paid for amounts included in the measurement of operating lease liabilities	$	—	$	682
Right of use assets obtained in exchange for operating lease liability	$	—	$	1,110

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 Stock			Additional Paid-In Capital		Accumulated Other Comprehensive Income (Loss)		Accumulated Deficit		Total Stockholders’ Equity (Deficit)
	Shares	Amount		Amount		Amount		Amount		Amount
Balance at December 31, 2019	46,189,870	$	5	$	1,194,327	$	3	$	(1,236,614)	$	(42,279)
Net loss								(37,654)		(37,654)
Unrealized gain from available-for-sale securities						(669)				(669)
Vesting of restricted shares	142,270									—



Issuance of common stock upon purchase by employee stock purchase plan	55,297			990						990

Share-based compensation expense				5,459						5,459
Balance at March 31, 2020	46,387,437	$	5	$	1,200,776	$	(666)	$	(1,274,268)	$	(74,153)

Balance at December 31, 2020	46,779,479	$	5	$	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 shares	202,018									—
Exercise of options	193,300			3,764						3,764

Issuance of common stock upon purchase by employee stock purchase plan	66,301			678						678

Share-based compensation expense				5,410						5,410
Balance at March 31, 2021	47,241,098	$	5	$	1,097,539	$	—	$	(1,313,554)	$	(216,010)

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” or the “Company”, “us”, “our” or “we”) is a commercial biopharmaceutical company committed to serving patients with unmet medical needs in endocrinology and other therapeutic areas. In April 2017, the Company’s first commercial product, TYMLOS (abaloparatide) injection, was approved by the U.S. Food and Drug Administration (“FDA”) for the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. We are a party to a license and development agreement with Teijin Limited (“Teijin”) for abaloparatide for subcutaneous injection (“abaloparatide-SC”) in Japan. In March 2021, Teijin received approval in Japan 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. The Company is developing an abaloparatide transdermal system, or abaloparatide-TD, for potential use in the treatment of postmenopausal women with osteoporosis. In 2020, we acquired certain assets related to formulations of cannabidiol (“CBD”) related to the oral administration of a solution of CBD for therapeutic use in humans or animals (“RAD011”). We are seeking FDA approval for a Phase 2/3 trial for RAD011 for treatment of hyperphagia-related behavior and anxiety in patients with Prader-Willi syndrome.

The Company is subject to risks common to companies in its industry including, but not limited to, the dependence on revenues from a single product, competition, uncertainty about clinical trial outcomes and regulatory approvals, uncertainties relating to pharmaceutical pricing reimbursement, uncertain protection of proprietary technology and potential product liability. As of March 31, 2021, the Company had an accumulated deficit of $1,313.6 million, and total cash and cash equivalents of $

SEC Form 10-Q filed by Radius Health, Inc.