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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 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 September 30, 2020

OR

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: 001-37725

 

ViewRay, Inc.

(Exact Name of Registrant as Specified in its Charter)

 

 

Delaware

 

42-1777485

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

2 Thermo Fisher Way

Oakwood Village, OH

 

44146

(Address of principal executive offices)

 

(Zip Code)

Registrant’s telephone number, including area code: (440) 703-3210

 

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, par value $0.01

 

VRAY

 

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 (§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.

 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  

As of October 29, 2020, the registrant had 148,499,601 shares of common stock, $0.01 par value per share, outstanding.

 

 

 

 


VIEWRAY, INC.

FORM 10-Q

TABLE OF CONTENTS

 

 

 

 

Page

 

 

 

 

PART I.

FINANCIAL INFORMATION

 

 

 

 

 

 

 

Cautionary Note Regarding Forward-Looking Statements

 

3

 

 

 

 

Item 1.

Unaudited Condensed Consolidated Financial Statements

 

4

 

 

 

 

 

Condensed Consolidated Balance Sheets

 

4

 

 

 

 

 

Condensed Consolidated Statements of Operations and Comprehensive Loss

 

5

 

 

 

 

 

Condensed Consolidated Statements of Stockholders’ Equity

 

6

 

 

 

 

 

Condensed Consolidated Statements of Cash Flows

 

7

 

 

 

 

 

Notes to the Condensed Consolidated Financial Statements

 

8

 

 

 

 

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

21

 

 

 

 

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

 

31

 

 

 

 

Item 4.

Controls and Procedures

 

31

 

 

 

 

PART II.

OTHER INFORMATION

 

 

 

 

 

 

Item 1.

Legal Proceedings

 

32

 

 

 

 

Item 1A.

Risk Factors

 

33

 

 

 

 

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

 

34

 

 

 

 

Item 3.

Defaults Upon Senior Securities

 

34

 

 

 

 

Item 4.

Mine Safety Disclosures

 

34

 

 

 

 

Item 5.

Other Information

 

34

 

 

 

 

Item 6.

Exhibits

 

35

 

 

 

 

 

Signatures

 

36

 


2


CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q, or this Report, contains forward-looking statements, including, without limitation, in the sections captioned “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and elsewhere. Any and all statements contained in this Report that are not statements of historical fact may be deemed forward-looking statements. Terms such as “will”, “may,” “might,” “would,” “should,” “could,” “project,” “estimate,” “pro forma,” “predict,” “potential,” “strategy,” “anticipate,” “attempt,” “develop,” “plan,” “help,” “believe,” “continue,” “intend,” “expect,” “future” and terms of similar import (including the negative of any of the foregoing) may be intended to identify forward-looking statements. However, not all forward-looking statements may contain one or more of these identifying terms. Forward-looking statements in this Report may include, without limitation, statements regarding (i) the plans and objectives of management for future operations, including plans or objectives relating to the development of products, (ii) a projection of income (including income/loss), earnings (including earnings/loss) per share, capital expenditures, dividends, capital structure or other financial items, (iii) our future financial performance, including any such statement contained in a discussion and analysis of financial condition by management or in the results of operations included pursuant to the rules and regulations of the Securities and Exchange Commission, or the SEC, and (iv) the assumptions underlying or relating to any statement described in points (i), (ii) or (iii) above.

The forward-looking statements are not meant to predict or guarantee actual results, performance, events or circumstances and may not be realized because they are based upon our current projections, plans, objectives, beliefs, expectations, estimates and assumptions and are subject to a number of risks and uncertainties and other influences, many of which we have no control over. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. Factors that may influence or contribute to the inaccuracy of the forward-looking statements or cause actual results to differ materially from expected or desired results may include, without limitation:

 

the effect of coronavirus and its associated disruption to the global economy and our business operations and financial condition;

 

market acceptance of magnetic resonance imaging (“MRI”) guided radiation therapy;

 

the benefits of MR Image-Guided radiation therapy;

 

our ability to successfully sell and market MRIdian® in our existing and expanded geographies;

 

the performance of MRIdian in clinical settings;

 

competition from existing technologies or products or new technologies and products that may emerge;

 

the pricing and reimbursement of MR Image-Guided radiation therapy;

 

the implementation of our business model and strategic plans for our business and MRIdian;

 

the scope of protection we are able to establish and maintain for intellectual property rights covering MRIdian;

 

our ability to obtain regulatory approval in targeted markets for MRIdian;

 

our ability to procure materials and components in connection with the manufacture and installation of MRIdian;

 

estimates of our future revenue, expenses, capital requirements and our need for additional financing;

 

our financial performance;

 

our expectations related to the MRIdian linear accelerator technology, or MRIdian Linac;

 

developments relating to our competitors and the healthcare industry; and

 

other risks and uncertainties, including those listed under the section titled “Risk Factors.”

Any forward-looking statements in this Report reflect our current views with respect to future events or to our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. Factors that may cause actual results to differ materially from current expectations include, among other things, those listed under Part II, Item 1A, titled “Risk Factors” and discussed elsewhere in this Report, and in Part I, Item 1A, titled “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2019. Given these uncertainties, you are cautioned not to place undue reliance on these forward-looking statements. We disclaim any obligation to update the forward-looking statements contained in this Report to reflect any new information or future events or circumstances or otherwise, except as required by law.

This Report also contains estimates, projections and other information concerning our industry, our business, and the markets for certain devices, including data regarding the estimated size of those markets. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties and actual events or circumstances may differ materially from events and circumstances reflected in this information. Unless otherwise expressly stated, we obtained this industry, business, market and other data from reports, research surveys, studies and similar data prepared by market research firms and other third parties, industry, medical and general publications, government data and similar sources.

3


PART I—FINANCIAL INFORMATION

 

Item 1. Unaudited Condensed Consolidated Financial Statements

VIEWRAY, INC.

Condensed Consolidated Balance Sheets

(In thousands, except share and per share data)

(Unaudited)

 

 

 

September 30, 2020

 

 

December 31, 2019

 

ASSETS

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

163,881

 

 

$

226,783

 

Accounts receivable

 

 

26,548

 

 

 

16,817

 

Inventory

 

 

46,456

 

 

 

55,031

 

Deposits on purchased inventory

 

 

4,254

 

 

 

6,457

 

Deferred cost of revenue

 

 

8,705

 

 

 

3,466

 

Prepaid expenses and other current assets

 

 

4,659

 

 

 

3,310

 

Total current assets

 

 

254,503

 

 

 

311,864

 

Property and equipment, net

 

 

22,533

 

 

 

23,399

 

Restricted cash

 

 

1,460

 

 

 

1,404

 

Intangible assets, net

 

 

51

 

 

 

55

 

Right-of-use assets

 

 

10,055

 

 

 

11,720

 

Other assets

 

 

1,485

 

 

 

1,577

 

TOTAL ASSETS

 

$

290,087

 

 

$

350,019

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

7,607

 

 

$

13,739

 

Accrued liabilities

 

 

17,966

 

 

 

21,390

 

Customer deposits

 

 

16,080

 

 

 

9,662

 

Operating lease liability, current

 

 

2,251

 

 

 

2,264

 

Current portion of long-term debt

 

 

15,556

 

 

 

1,556

 

Deferred revenue, current

 

 

21,838

 

 

 

10,457

 

Total current liabilities

 

 

81,298

 

 

 

59,068

 

Deferred revenue, net of current portion

 

 

2,884

 

 

 

3,553

 

Long-term debt

 

 

40,134

 

 

 

53,995

 

Warrant liabilities

 

 

4,092

 

 

 

5,373

 

Operating lease liability, noncurrent

 

 

8,816

 

 

 

10,479

 

Other long-term liabilities

 

 

1,827

 

 

 

1,377

 

TOTAL LIABILITIES

 

 

139,051

 

 

 

133,845

 

Commitments and contingencies (Note 6)

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

Preferred stock, par value of $0.01 per share; 10,000,000 shares authorized

   at September 30, 2020 and December 31, 2019; no shares issued and outstanding

   at September 30, 2020 and December 31, 2019

 

 

 

 

 

 

Common stock, par value of $0.01 per share; 300,000,000 shares authorized at

   September 30, 2020 and December 31, 2019; 147,954,426 and 147,191,695 shares

   issued and outstanding at September 30, 2020 and December 31, 2019

 

 

1,469

 

 

 

1,462

 

Additional paid-in capital

 

 

750,552

 

 

 

733,888

 

Accumulated deficit

 

 

(600,985

)

 

 

(519,176

)

TOTAL STOCKHOLDERS’ EQUITY

 

 

151,036

 

 

 

216,174

 

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

 

$

290,087

 

 

$

350,019

 

 

 

 

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

4


VIEWRAY, INC.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(In thousands, except share and per share data)

(Unaudited)

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Product

 

$

6,210

 

 

$

18,696

 

 

$

28,295

 

 

$

65,475

 

Service

 

 

3,758

 

 

 

2,048

 

 

 

9,909

 

 

 

5,482

 

Distribution rights

 

 

118

 

 

 

118

 

 

 

356

 

 

 

356

 

Total revenue

 

 

10,086

 

 

 

20,862

 

 

 

38,560

 

 

 

71,313

 

Cost of revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Product

 

 

8,550

 

 

 

18,521

 

 

 

34,393

 

 

 

63,368

 

Service

 

 

2,600

 

 

 

1,767

 

 

 

8,380

 

 

 

9,489

 

Total cost of revenue

 

 

11,150

 

 

 

20,288

 

 

 

42,773

 

 

 

72,857

 

Gross margin

 

 

(1,064

)

 

 

574

 

 

 

(4,213

)

 

 

(1,544

)

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

5,245

 

 

 

5,641

 

 

 

17,793

 

 

 

17,135

 

Selling and marketing

 

 

2,669

 

 

 

7,297

 

 

 

11,585

 

 

 

19,845

 

General and administrative

 

 

16,031

 

 

 

19,381

 

 

 

47,046

 

 

 

49,888

 

Total operating expenses

 

 

23,945

 

 

 

32,319

 

 

 

76,424

 

 

 

86,868

 

Loss from operations

 

 

(25,009

)

 

 

(31,745

)

 

 

(80,637

)

 

 

(88,412

)

Interest income

 

 

5

 

 

 

484

 

 

 

787

 

 

 

1,391

 

Interest expense

 

 

(1,074

)

 

 

(1,069

)

 

 

(3,183

)

 

 

(2,902

)

Other (expense) income, net

 

 

(2,047

)

 

 

11,499

 

 

 

1,224

 

 

 

4,933

 

Loss before provision for income taxes

 

$

(28,125

)

 

$

(20,831

)

 

$

(81,809

)

 

$

(84,990

)

Provision for income taxes

 

 

 

 

 

 

 

 

 

 

 

 

Net loss and comprehensive loss

 

$

(28,125

)

 

$

(20,831

)

 

$

(81,809

)

 

$

(84,990

)

Net loss per share, basic and diluted

 

$

(0.19

)

 

$

(0.21

)

 

$

(0.55

)

 

$

(0.87

)

Weighted-average common shares used to compute net loss per

   share attributable to common stockholders, basic and diluted

 

 

148,042,972

 

 

 

99,039,789

 

 

 

147,683,344

 

 

 

97,763,964

 

 

 

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

 

5


VIEWRAY, INC.

Condensed Consolidated Statements of Stockholders’ Equity

(In thousands, except share and per share data)

(Unaudited)

 

 

 

Common Stock

 

 

 

 

 

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Additional

Paid-in

Capital

 

 

Accumulated

Deficit

 

 

Total

Stockholders’

Equity

 

Three Months Ended September 30, 2020

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at June 30, 2020

 

 

147,616,373

 

 

$

1,466

 

 

$

745,418

 

 

$

(572,860

)

 

$

174,024

 

Stock-based compensation

 

 

 

 

 

 

 

 

5,759

 

 

 

 

 

 

5,759

 

Issuance of common stock from releases of restricted stock units

 

 

338,053

 

 

 

3

 

 

 

(3

)

 

 

 

 

 

 

Tax withholding paid on behalf of employees for stock-based awards

 

 

 

 

 

 

 

 

(622

)

 

 

 

 

 

(622

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

(28,125

)

 

 

(28,125

)

Balance at September 30, 2020

 

 

147,954,426

 

 

$

1,469

 

 

$

750,552

 

 

$

(600,985

)

 

$

151,036

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Nine Months Ended September 30, 2020

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at December 31, 2019

 

 

147,191,695

 

 

$

1,462

 

 

$

733,888

 

 

$

(519,176

)

 

$

216,174

 

Issuance of common stock from option exercises

 

 

20,579

 

 

 

 

 

 

15

 

 

 

 

 

 

15

 

Stock-based compensation

 

 

 

 

 

 

 

 

17,063

 

 

 

 

 

 

17,063

 

Issuance of common stock from releases of restricted stock units

 

 

659,920

 

 

 

6

 

 

 

(6

)

 

 

 

 

 

 

Tax withholding paid on behalf of employees for stock-based awards

 

 

 

 

 

 

 

 

(754

)

 

 

 

 

 

(754

)

Issuance of common stock from employee stock purchase plan

 

 

82,232

 

 

 

1

 

 

 

155

 

 

 

 

 

 

156

 

Write-down of offering costs related to previous issuance of common stock upon public offering

 

 

 

 

 

 

 

 

191

 

 

 

 

 

 

191

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(81,809

)

 

 

(81,809

)

Balance at September 30, 2020

 

 

147,954,426

 

 

$

1,469

 

 

$

750,552

 

 

$

(600,985

)

 

$

151,036

 

 

 

 

Common Stock

 

 

 

 

 

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Additional

Paid-in

Capital

 

 

Accumulated

Deficit

 

 

Total

Stockholders’

Equity

 

Three Months Ended September 30, 2019

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at June 30, 2019

 

 

98,259,203

 

 

$

973

 

 

$

585,080

 

 

$

(463,136

)

 

$

122,917

 

Issuance of common stock from option exercises

 

 

517,624

 

 

 

5

 

 

 

1,433

 

 

 

 

 

 

1,438

 

Stock-based compensation

 

 

 

 

 

 

 

 

4,910

 

 

 

 

 

 

4,910

 

Issuance of common stock from releases of restricted stock units

 

 

335,863

 

 

 

3

 

 

 

(3

)

 

 

 

 

 

 

Tax withholding paid on behalf of employees for stock-based awards

 

 

 

 

 

 

 

 

(2,410

)

 

 

 

 

 

(2,410

)

Issuance of common stock from warrant exercises

 

 

293,115

 

 

 

3

 

 

 

(3

)

 

 

 

 

 

 

Reclassification of warrant liability to additional paid-in capital upon warrant exercises

 

 

 

 

 

 

 

 

1,871

 

 

 

 

 

 

1,871

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(20,831

)

 

 

(20,831

)

Balance at September 30, 2019

 

 

99,405,805

 

 

$

984

 

 

$

590,878

 

 

$

(483,967

)

 

$

107,895

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Nine Months Ended September 30, 2019

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at December 31, 2018

 

 

96,332,023

 

 

$

952

 

 

$

565,334

 

 

$

(398,977

)

 

$

167,309

 

Issuance of common stock from option exercises

 

 

2,219,251

 

 

 

23

 

 

 

9,618

 

 

 

 

 

 

9,641

 

Stock-based compensation

 

 

 

 

 

 

 

 

14,369

 

 

 

 

 

 

14,369

 

Issuance of common stock from releases of restricted stock units

 

 

390,332

 

 

 

4

 

 

 

(4

)

 

 

 

 

 

 

Tax withholding paid on behalf of employees for stock-based awards

 

 

 

 

 

 

 

 

(2,410

)

 

 

 

 

 

(2,410

)

Issuance of common stock from warrant exercises

 

 

464,199

 

 

 

5

 

 

 

(5

)

 

 

 

 

 

 

Reclassification of warrant liability to additional paid-in capital upon warrant exercises

 

 

 

 

 

 

 

 

3,976

 

 

 

 

 

 

3,976

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(84,990

)

 

 

(84,990

)

Balance at September 30, 2019

 

 

99,405,805

 

 

$

984

 

 

$

590,878

 

 

$

(483,967

)

 

$

107,895

 

 

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

 

 

6


VIEWRAY, INC.

Condensed Consolidated Statements of Cash Flows

(In thousands)

(Unaudited)

 

 

 

Nine Months Ended September 30,

 

 

 

2020

 

 

2019

 

CASH FLOWS FROM OPERATING ACTIVITIES:

 

 

 

 

 

 

 

 

Net loss

 

$

(81,809

)

 

$

(84,990

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

 

 

Depreciation and amortization