cfms-20210331

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

☒ 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: 001-37474

Conformis, Inc.

(Exact name of registrant as specified in its charter)


Delaware			56-2463152
(State or other jurisdiction of incorporation or organization)			(I.R.S. Employer Identification Number)


600 Technology Park Drive Billerica, MA			01821
(Address of principal executive offices)			(Zip Code)

(781) 345-9001

(Registrant’s telephone number, including area code)

(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, or a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer” and “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	☐

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 ☒

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, $0.00001 par value

CFMS

The Nasdaq Capital Market

As of April 30, 2021, there were 182,476,224 shares of Common Stock, $0.00001 par value per share, outstanding.

Conformis, Inc.

INDEX


			Page

Part I - FINANCIAL INFORMATION
Item 1. Financial Statements (interim periods unaudited)			1
Consolidated Balance Sheets as of March 3 1 , 202 1 and December 31, 2020			1
Consolidated Statements of Operations for the three months ended March 3 1 , 202 1 and 20 20			2
Consolidated Statements of Comprehensive Loss for the three months ended March 3 1 , 202 1 and 20 20			3
Consolidated Statements of Changes in Stockholders' Equity for the three months ended March 3 1 , 202 1 and 20 20			4
Consolidated Statements of Cash Flows for the three months ended March 3 1 , 202 1 and 20 20			5
Notes to Consolidated Financial Statements			6
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations			29

Item 4. Controls and Procedures			44

Part II- OTHER INFORMATION
Item 1. Legal Proceedings			45
Item 1A. Risk Factors			46
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds			47
Item 5. Other Information			47
Item 6. Exhibits			48
Signatures			49

PART I - FINANCIAL INFORMATION

Item 1. FINANCIAL STATEMENTS

CONFORMIS, INC. AND SUBSIDIARIES

Consolidated Balance Sheets

(in thousands, except share and per share data)


	March 31, 2021		December 31, 2020
	(unaudited)
Assets
Current Assets
Cash and cash equivalents	$	104,597	$	28,673

Accounts receivable, net	8,223		8,515
Royalty and licensing receivable	131		1,256
Inventories, net	13,341		12,585
Prepaid expenses and other current assets	2,587		2,315
Total current assets	128,879		53,344
Property and equipment, net	11,547		12,240
Operating lease right-of-use assets	4,903		5,215
Other Assets
Restricted cash	462		462



Other long-term assets	229		239
Total assets	$	146,020	$	71,500

Liabilities and stockholders' equity
Current liabilities
Accounts payable	$	5,005	$	4,918
Accrued expenses	6,357		7,213
Operating lease liabilities	1,658		1,620
Advance on research and development	2,651		3,168
Contract liability	14,000		14,000

Total current liabilities	29,671		30,919



Long-term debt, less debt issuance costs	25,172		25,003
Operating lease liabilities	3,852		4,206
Total liabilities	58,695		60,128
Commitments and contingencies
Stockholders’ equity
Preferred stock, $0.00001 par value:
Authorized: 5,000,000 shares authorized at March 31, 2021 and December 31, 2020; no shares issued and outstanding as of March 31, 2021 and December 31, 2020	—		—
Common stock, $0.00001 par value:
Authorized: 200,000,000 shares authorized at March 31, 2021 and December 31, 2020; 182,428,111 and 95,546,577 shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively	2		1
Additional paid-in capital	629,622		543,809
Accumulated deficit	(539,944)		(528,438)
Accumulated other comprehensive loss	(2,355)		(4,000)
Total stockholders’ equity	87,325		11,372
Total liabilities and stockholders’ equity	$	146,020	$	71,500

The accompanying notes are an integral part of these consolidated financial statements.

CONFORMIS, INC. AND SUBSIDIARIES

Consolidated Statements of Operations

(unaudited)

(in thousands, except share and per share data)


	Three Months Ended March 31,
	2021		2020
Revenue
Product	$	13,711	$	16,290
Royalty and licensing	124		185
Total revenue	13,835		16,475
Cost of revenue	7,662		9,261
Gross profit	6,173		7,214

Operating expenses
Sales and marketing	5,113		6,563
Research and development	3,540		2,990
General and administrative	6,666		5,736

Total operating expenses	15,319		15,289
Loss from operations	(9,146)		(8,075)

Other income and expenses
Interest income	18		35
Interest expense	(594)		(574)

Foreign currency exchange transaction loss	(1,761)		(714)
Total other expenses	(2,337)		(1,253)
Loss before income taxes	(11,483)		(9,328)
Income tax provision	23		25

Net loss

SEC Form 10-Q filed by ConforMIS, Inc.