rmed-10q_20200930.htm

(Former name, former address and former fiscal year, if changed since last report)

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 (§232.405 of this chapter) 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.

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 ☒

As of November 11, 2020, the registrant had 72,982,062 shares of common stock, par value $0.0001 per share, outstanding.

	September 30, 2020			December 31, 2019
ASSETS
Current Assets
Cash and cash equivalents	$	33,646		$	14,584
Short-term investments		—			15,993
Accounts receivable, net		475			786
Inventories		2,592			2,777
Prepaid expenses and other current assets		466			1,860
Total current assets		37,179			36,000
Property and equipment, net		3,581			5,050
Operating lease right-of-use-assets		2,574			2,835
Other non-current assets		120			196
TOTAL ASSETS	$	43,454		$	44,081
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current Liabilities
Accounts payable	$	899		$	1,532
Accrued expenses		4,591			2,642
Current portion of deferred revenue		1,729			2,029
Current portion of equipment financing		306			293
Current portion of promissory note		168			—
Current portion of operating lease liabilities		346			318
Total current liabilities		8,039			6,814
Deferred revenue		656			1,232
Equipment financing		34			265
Promissory note		1,832			—
Operating lease liabilities		2,355			2,620
Total liabilities		12,916			10,931
Commitments and contingencies (Note 13)
Stockholders’ Equity
Preferred stock, $0.0001 par value, 10,000,000 authorized at September 30, 2020 and December 31, 2019, respectively; none issued		—			—
Common stock, $0.0001 par value, 300,000,000 shares authorized; 72,468,337 and 13,770,349 issued and outstanding at September 30, 2020 and December 31, 2019, respectively		7			1
Additional paid-in capital		173,289			150,280
Accumulated deficit		(142,758	)		(117,157	)
Accumulated other comprehensive income		—			26
Total stockholders’ equity		30,538			33,150
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY	$	43,454		$	44,081

	Three Months Ended September 30,						Nine Months Ended September 30,
	2020			2019			2020			2019
Net revenue
Product sales	$	183		$	1,078		$	923		$	3,256
Service and other		731			830			2,265			2,553
Total net revenue		914			1,908			3,188			5,809
Cost of revenue
Product sales		670			1,518			2,258			4,848
Service and other		748			907			1,911			2,252
Total cost of revenue		1,418			2,425			4,169			7,100
Gross loss		(504	)		(517	)		(981	)		(1,291	)
Operating expenses
Selling, general and administrative		4,933			15,889			19,114			42,907
Research and development		2,332			1,182			5,580			3,692
Total operating expenses		7,265			17,071			24,694			46,599
Operating loss		(7,769	)		(17,588	)		(25,675	)		(47,890	)
Other income (expense), net
Interest income	4				245		128				870
Interest expense		(14	)		(72	)		(54	)		(186	)
Total other income (expense), net		(10	)		173			74			684
Loss before income tax expense		(7,779	)		(17,415	)		(25,601	)		(47,206	)
Income tax expense		—			3			—			8
Net loss		(7,779	)		(17,418	)		(25,601	)		(47,214	)
Basic and diluted net loss per share	$	(0.13	)	$	(1.30	)	$	(0.79	)	$	(3.63	)
Basic and diluted weighted average common shares outstanding		59,638			13,370			32,443			13,023

	Three Months Ended September 30,						Nine Months Ended September 30,
	2020			2019			2020			2019
Net loss	$	(7,779	)	$	(17,418	)	$	(25,601	)	$	(47,214	)
Other comprehensive (loss) income:
Unrealized (losses) gains related to short-term investments		—			(13	)		(26	)		38
Total other comprehensive (loss) income	$	—		$	(13	)	$	(26	)	$	38
Comprehensive loss	$	(7,779	)	$	(17,431	)	$	(25,627	)	$	(47,176	)

	Nine Months Ended September 30,
	2020			2019
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$	(25,601	)	$	(47,214	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation		1,584			1,046
Operating lease right-of-use-assets amortization		261			245
Provision for doubtful accounts		25			266
Stock-based compensation		3,044			22,154
Loss on disposal of property and equipment		64			—
Changes in operating assets and liabilities:
Accounts receivable		286			(242	)
Inventories		78			(1,774	)
Prepaid expenses and other assets		1,437			438
Accounts payable		(633	)		(121	)
Accrued expenses		1,678			1,577
Deferred revenue		(876	)		234
Other liabilities		(237	)		(210	)
Net cash used in operating activities		(18,890	)		(23,601	)
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchases of available-for-sale securities		—			(36,461	)
Proceeds from maturities of available-for-sale securities		16,000			10,697
Purchases of property and equipment		(72	)		(220	)
Net cash provided by (used in) investing activities		15,928			(25,984	)
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from issuance of common stock and warrants, net of placement agent fees of $2,113		19,887			—
Proceeds from issuance of common stock in connection with the exercise of warrants		827			—
Proceeds from issuance of common stock in connection with the employee stock purchase plan		27			37
Proceeds from promissory note		2,000			—
Payments on equipment financing		(218	)		(255	)
Payments of offering costs related to the issuance of common stock and warrants		(499	)		—
Net cash provided by (used in) financing activities		22,024			(218	)
NET CHANGE IN CASH AND CASH EQUIVALENTS		19,062			(49,803	)
CASH AND CASH EQUIVALENTS, beginning of period		14,584			64,315
CASH AND CASH EQUIVALENTS, end of period	$	33,646		$	14,512
SUPPLEMENTAL DISCLOSURE OF NON-CASH INVESTING AND FINANCING ACTIVITIES:
Unpaid offering costs	$	281		$	—
Transfer from inventories to property and equipment for lasers	$	107		$	1,299
Unpaid property and equipment included in equipment financing	$	—		$	156
SUPPLEMENTAL CASH FLOW INFORMATION:
Cash payments for interest	$	23		$	39
Cash payments for taxes	$	—		$	24

	Common Stock Shares		Common Stock Amount		Additional Paid- in- Capital		Accumulated Other Comprehensive Income (Loss)			Accumulated Deficit			Total Stockholders’ Equity
Balances at December 31, 2019		13,770	$	1	$	150,280	$	26		$	(117,157	)	$	33,150
Common stock issued		125		—		—		—			—			—
Stock-based compensation		—		—		1,047		—			—			1,047
Other comprehensive loss		—		—		—		(22	)		—			(22	)
Net loss		—		—		—		—			(7,701	)		(7,701	)
Balances at March 31, 2020		13,895	$	1	$	151,327	$	4		$	(124,858	)	$	26,474
Common stock issued, net		22,222		2		5,282		—			—			5,284
Warrants issued, net		—		—		3,464		—			—			3,464
Exercise of warrants		1,838		1		826		—			—			827
Common stock issued pursuant to the vesting of restricted stock units and ESPP		228		—		27		—			—			27
Stock-based compensation		—		—		1,033		—			—			1,033
Other comprehensive loss		—		—		—		(4	)		—			(4	)
Net loss		—		—		—		—			(10,121	)		(10,121	)
Balances at June 30, 2020		38,183	$	4	$	161,959	$	—		$	(134,979	)	$	26,984
Common stock issued, net		34,285		3		6,338		—			—			6,341
Warrants issued, net		—		—		4,028		—			—			4,028
Stock-based compensation		—		—		964		—			—			964
Net loss		—		—		—		—			(7,779	)		(7,779	)
Balances at September 30, 2020		72,468	$	7	$	173,289	$	—		$	(142,758	)	$	30,538

	Common Stock Shares		Common Stock Amount		Additional Paid- in- Capital		Accumulated Other Comprehensive Income (Loss)			Accumulated Deficit			Total Stockholders’ Equity
Balances at December 31, 2018		12,689	$	1	$	126,925	$	—		$	(60,221	)	$	66,705
Adoption of accounting standard (See Note 2)		—		—		—		—			21			21
Balances at January 1, 2019		12,689		1		126,925		—			(60,200	)		66,726
Common stock issued		148		—				—			—			—
Stock-based compensation		—		—		7,745		—			—			7,745
Net loss		—		—		—		—			(14,674	)		(14,674	)
Balances at March 31, 2019		12,837	$	1	$	134,670	$	—		$	(74,874	)	$	59,797
Common stock issued		384		—		37		—			—			37
Stock-based compensation		—		—		7,132		—			—			7,132
Other comprehensive income		—		—		—		51			—			51
Net loss		—		—		—		—			(15,122	)		(15,122	)
Balances at June 30, 2019		13,221	$	1	$	141,839	$	51		$	(89,996	)	$	51,895
Common stock issued		187		—		—		—			—			—
Stock-based compensation		—		—		7,277		—			—			7,277
Other comprehensive income		—		—		—		(13	)		—			(13	)
Net loss		—		—		—		—			(17,418	)		(17,418	)
Balances at September 30, 2019		13,408	$	1	$	149,116	$	38		$	(107,414	)	$	41,741

Ra Medical Systems, Inc. (the “Company”) was formed in September 4, 2002, in the state of California and reincorporated in Delaware on July 14, 2018. The Company is a medical device company that develops, manufactures and markets advanced excimer laser systems for use in the treatment of vascular and dermatological diseases. The Company’s product development centers around proprietary applications of its advanced excimer laser technology for use as a tool in the treatment of peripheral artery disease (“PAD”) and psoriasis, vitiligo, atopic dermatitis and leukoderma.

In July 2018, the Company reincorporated in Delaware. In connection with the Company’s initial public offering (“IPO”), which closed on October 1, 2018, the Company filed an Amended and Restated Certificate of Incorporation which authorizes the issuance of 300,000,000 shares of common stock with a par value of $0.0001 and 10,000,000 shares of preferred stock with a par value of $0.0001.

COVID-19—The global spread of the novel coronavirus (COVID-19) has created significant volatility, uncertainty and economic disruption. The ultimate effects of the COVID-19 on the Company’s business, operations and financial condition are unknown at this time. In the near term, the Company expects that its revenue will continue to be adversely impacted and enrollment in its atherectomy clinical trial will continue to be delayed or slowed, as patients elect to postpone voluntary treatments and many physicians’ offices have been either closed or operating at a reduced capacity. In addition, some customers are requesting more flexible payment terms on a temporary basis. The Company’s manufacturing facility located in Carlsbad, California is currently operational. Employee travel is limited to essential travel only and many employees are working from home when feasible. The Company has experienced minor delays in receiving shipments of parts, which has not had a material impact on the timing of its key engineering efforts, nor ability to support its atherectomy indication clinical trial. However, the extent to which COVID-19 impacts its business will depend on future developments, which are highly uncertain and cannot be predicted, including new information which may emerge concerning the severity of COVID-19 and the actions to contain it or treat its impact, among others.

Going Concern — The condensed financial statements have been prepared on a going concern basis, which contemplates the realization of assets and settlement of liabilities in the normal course of business, and do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or amounts and classification of liabilities that may result from the outcome of this uncertainty.

The Company has experienced recurring net losses from operations and negative cash flows from operating activities, has a significant accumulated deficit and expects to continue to incur net losses into the foreseeable future. The Company had an accumulated deficit of $142.8 million at September 30, 2020. For the year ended December 31, 2019 and the nine months ended September 30, 2020, the Company used $33.2 million and $18.9 million for operating activities, respectively.

As of September 30, 2020, the Company had cash and cash equivalents of $33.6 million.

Management expects operating losses and negative cash flows to continue for the foreseeable future with the Company’s reduced commercial footprint, and as the Company continues to incur costs related to its atherectomy clinical trial, engineering efforts to improve the shelf-life of its catheters and develop next generation products and legal costs associated with ongoing litigation. In September 2020, the Company paused commercial sales of DABRA catheters not being used for the atherectomy clinical trial while it continues its engineering efforts to improve the shelf-life of its catheters. Additional test data will need to be submitted and approved by the FDA prior to resuming commercial shipments of catheters. The Company expects this to be resolved in the first quarter of 2021. The Company also expects the COVID-19 pandemic to have a continued negative impact on its revenue and the timing of enrollment in its atherectomy clinical trial as well as the Company’s ability to secure additional financing in a timely manner or on favorable terms, if at all.

Although the Company has bolstered its liquidity resources in 2020, management concluded that the aforementioned conditions, particularly the ongoing uncertainty related to the negative impacts of the COVID-19 pandemic, continue to raise substantial doubt about the Company’s ability to continue as a going concern within 12 months from the date of issuance of the financial statements. Management’s plans to address this uncertainty include raising additional funding, if necessary, through public or private equity or debt financings. However, the Company may not be able to secure such financing in a timely manner or on favorable terms, if at all. Furthermore, if the Company issues equity securities to raise additional funds, its existing stockholders may experience dilution, and the new equity securities may have rights, preferences and privileges senior to those of the Company’s existing stockholders.

Interim condensed financial information—The unaudited interim condensed financial statements have been prepared on the same basis as the annual financial statements and reflect all adjustments of a normal and recurring nature that are necessary for the fair presentation of the Company’s condensed balance sheets, results of operations, cash flows and statement of stockholders’ equity for the periods presented. The results of operations for the three and nine months ended September 30, 2020 are not necessarily indicative of the results to be expected for the year ending December 31, 2020 or for any other future annual or interim period. The balance sheet as of December 31, 2019 included herein was derived from the audited financial statements as of that date. These unaudited condensed financial statements should be read in conjunction with the Company’s audited financial statements included in the Company’s Annual Report on Form 10-K filed with the SEC on March 11, 2020.

Use of estimates—The financial statements of the Company have been prepared by management in accordance with accounting principles generally accepted in the United States of America. The preparation of the financial statements requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities and reported disclosures of contingent liabilities at the dates of the financial statements and the reported amounts of revenue and expenses during the reporting periods. Actual results could differ from those estimates. The Company’s financial statements are based upon a number of estimates, including but not limited to, allowance for doubtful accounts, reserves for warranty costs including product recalls, evaluation of probable loss contingencies, fair value of stock option awards granted and revenue recognition for multiple performance obligations.

Fair value measurements—Fair value represents the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants and is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. A three-tier value hierarchy is used to identify inputs used in measuring fair value as follows:

Level 1—Observable inputs that reflect quoted market prices (unadjusted) for identical assets or liabilities in active markets.

Level 2—Inputs other than the quoted prices in active markets that are observable either directly or indirectly in the marketplace for identical or similar assets and liabilities; and

Level 3—Unobservable inputs that are supported by little or no market data, which require the Company to develop its own assumptions.

The hierarchy requires the Company to use observable market data, when available, and to minimize the use of unobservable inputs when determining fair value.

The Company measures its cash and cash equivalents and short-term investments at fair value.

Product warranty—The Company records estimated product warranty costs at the time of sale. Products are warrantied against defects in material and workmanship when properly used for their intended purpose and appropriately maintained. Accordingly, the Company generally replaces catheters that kink or fail to calibrate. The product warranty liability is determined based on historical information such as past experience, product failure rates or number of units repaired, estimated cost of material and labor. The product warranty liability also includes the estimated costs of a product recall.

Product warranties are included for the first year after the sale for laser sales. For lasers, the customer may purchase an extended service contract, which is either negotiated in the contract or sold as a separate component for which revenue is recognized over the term of the agreement.

The warranty accrual is included in accrued expenses in the accompanying balance sheets. Warranty expenses are included in cost of revenue in the accompanying statements of operations. Changes in estimates to previously established warranty accruals

result from current period updates to assumptions regarding repair and product recall costs and are included in current period warranty expense.

Inventories—Inventories are stated at the lower of cost (first-in, first-out method) or net realizable value. Cost includes materials, labor and manufacturing overhead related to the purchase and production of inventories. The Company reduces the carrying value of inventories for those items that are potentially excess, obsolete or slow-moving based on changes in customer demand, technological developments or other economic factors.

Catheters are manufactured in-house and each catheter is tested at various stages of the manufacturing process for adherence to quality standards. Catheters that do not meet functionality specification at each test point are destroyed and immediately written off, with the expense recorded in cost of revenue in the statement of operations. Once manufactured, completed catheters that pass quality assurance, are sent to a third-party for sterilization and sealed in a sterile container. Upon return from the third-party sterilizer, a sample of catheters from each batch are re-tested. If the sample tests are successful, the batch is accepted into finished goods inventory and if the sample tests are unsuccessful, the entire batch is written off, with the expense recorded in cost of revenue in the statement of operations.

Revenue—The Company generates revenue from the sale of products and services. Product sales consist of the sale of DABRA and Pharos laser systems, the sale of catheters for use with the DABRA laser, and the sale of consumables and replacement parts. The Company’s sales agreements generally do not include right-of-return provisions for any form of consideration including partial refund or credit against amounts owed to the Company. Services and other revenue primarily consist of sales of extended warranty and billable services, including repair activity and income from rental of lasers.

The Company enters into a DABRA laser commercial usage agreement or DABRA laser placement acknowledgement with each customer that is supplied a DABRA laser, collectively the “usage agreement”. The usage agreement provides for specific terms of continued use of DABRA laser, including a nominal periodic fee. The terms of a usage agreement typically allow the Company to place a DABRA laser at a customer’s specified location without a specified contract term. Under the usage agreement terms, the Company retains all ownership rights to the DABRA laser and is permitted to request the return of the equipment within 10 business days of notification. While the laser periodic fees are nominal, the laser usage agreements provide the Company the exclusive rights to supply related single-use catheters to the customer which aggregate the majority of the vascular segment revenue. There are no specified minimum purchase commitments for the catheters.

The Company recognizes revenue associated with the usage agreement and catheter supply arrangements in accordance with Topic 606 as the contract primarily includes variable payments, the catheters are priced at their standalone selling price and the laser equipment is insignificant in the context of the contract. Revenue is recognized when the performance obligation is satisfied, which is generally upon shipment of the catheter.

Sales of laser systems and are included in product sales in the statements of operations. The Company recognizes revenue on laser sales at the point in time that control transfers to the customer. Control of the product typically transfers upon shipment.

The Company typically provides a 12-month warranty with the purchase of its laser systems. Customers can extend the warranty period through the purchase of extended warranty service contracts. Extended warranty service contracts are sold with contract terms ranging from 12 to 60 months and cover periods after the end of the initial 12-month warranty period. The warranty provides the customer with maintenance services in addition to the assurance that the laser product complies with agreed-upon specifications. Therefore, the warranty service is treated as a separate performance obligation from the laser system. Warranty services are a stand-ready obligation, and the Company recognizes revenue on a straight-line basis over the service contract term. Warranty service revenue is included in service and other revenue in the statements of operations. Deferred revenue at December 31, 2019 was $3.3 million. Revenue recognized in each of the three months ended September 30, 2020 and 2019 relating to amounts previously included in deferred revenue was $0.4 million. Revenue recognized in the nine months ended September 30, 2020 and 2019 was $1.7 million and $1.6 million, respectively. The deferred revenue greater than one year will be recognized during the remaining service period through 2024.

In certain markets outside the U.S., the Company sells products and provides services to customers through distributors that specialize in medical device products. The terms of sales transactions through distributors are generally consistent with the terms of direct sales to customers. The Company accounts for these transactions in accordance with the Company’s revenue recognition policy described herein.

The Company capitalizes costs to obtain contracts that are considered incremental and recoverable, such as sales commissions. The capitalized costs are amortized to selling, general and administrative expense over the estimated period of benefit of the asset, which is the contract term. The Company elected to use the practical expedient to expense the costs to obtain a contract when the amortization period is less than one year. The Company has contract costs of $0.2 million and $0.4 million capitalized at September 30, 2020 and December 31, 2019, respectively.

The Company also derives income pursuant to product lease agreements for its Pharos laser systems, as operating leases. Consequently, the Company retains title to the equipment and the equipment remains on Company’s balance sheet within property and equipment. Depreciation expense on these leased lasers is recorded to cost of revenues on a straight-line basis. The costs to maintain these leased lasers are charged to cost of revenues as incurred.

These lease arrangements contain one lease component (the laser) and one nonlease component (warranty service) for which the Company elected the practical expedient to not separate the nonlease component from the lease component. The Company accounts for the combined lease component as an operating lease and recognizes lease income on a straight-line basis over the lease term. Rental income from lease arrangements for the three months ended September 30, 2020 and September 30, 2019 was $0.1 million and $0.2 million, respectively. Rental income from lease arrangements for each of the nine months ended September 30, 2020 and 2019 was $0.4 million and $0.5 million, respectively.

Recently Adopted Accounting Pronouncements—In June 2018, the FASB issued ASU 2018-07, Improvements to Nonemployee Share-Based Payment Accounting. ASU 2018-07 expands the scope of Topic 718, Compensation—Stock Compensation, to include share-based payments issued to nonemployees for goods or services. Consequently, the accounting for share-based payments to nonemployees and employees will be substantially aligned. ASU 2018-07 supersedes Subtopic 505-50, Equity—Equity-Based Payments to Non-Employees. The amendments are effective for fiscal years beginning after December 15, 2019. Early adoption is permitted, but no earlier than a company’s adoption date of Topic 606, Revenue from Contracts with Customers. The Company adopted this guidance on January 1, 2020 and there was no impact on the financial statements and related disclosures.

In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820) - Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement, which is designed to improve the effectiveness of disclosures by removing, modifying and adding disclosures related to fair value measurements. ASU No. 2018-13 is effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years, and the ASU allows for early adoption in any interim period after issuance of the update. The Company adopted this guidance of January 1, 2020 and there was no impact on the financial statements and related disclosures.

In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326), to require the measurement of expected credit losses for financial instruments held at the reporting date based on historical experience, current conditions and reasonable forecasts and applies to all financial assets, including trade receivables. The main objective of this ASU is to provide financial statement users with more decision-useful information about the expected credit losses on financial instruments and other commitments to extend credit held by a reporting entity at each reporting date. ASU No. 2016-13 is effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years. The Company adopted this guidance on January 1, 2020 and there was no material impact on the financial statements and related disclosures.

The following table presents the hierarchy for assets measured at fair value on a recurring basis (in thousands):

	Total Fair Value		Quoted Market Prices for Identical Assets (Level 1)		Other Observable Inputs (Level 2)		Unobservable Inputs (Level 3)
As of September 30, 2020
Money market funds	$	18,393	$	18,393	$	—	$	—
As of December 31, 2019
Money market funds	$	13,219	$	13,219	$	—	$	—
U.S. government securities	$	14,993	$	14,993	$	—	$	—
U.S. agency securities	$	1,000	$	—	$	1,000	$	—

Delaware		38-3661826
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)

2070 Las Palmas Drive Carlsbad, California		92011
(Address of principal executive offices)		(Zip Code)

PART I. FINANCIAL INFORMATION		Page
Item 1.	Financial Statements:	3
	Condensed Balance Sheets (unaudited)	3
	Condensed Statements of Operations (unaudited)	4
	Condensed Statements of Comprehensive Loss (unaudited)	5
	Condensed Statements of Cash Flows (unaudited)	6
	Condensed Statements of Stockholders’ Equity (unaudited)	7
	Notes to Condensed Financial Statements (unaudited)	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	30
Item 4.	Controls and Procedures	31
PART II. OTHER INFORMATION		32
Item 1.	Legal Proceedings	32
Item 1A.	Risk Factors	34
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	82
Item 3.	Defaults Upon Senior Securities	82
Item 4.	Mine Safety Disclosures	82
Item 5.	Other Information	83
Item 6.	Exhibits	84
SIGNATURES		85

	September 30, 2020		December 31, 2019
Raw materials	$	2,259	$	2,300
Work in process		167		215
Finished goods		166

Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
		Emerging growth company	☒