10-Q 1 vray-10q_20160331.htm 10-Q vray-10q_20160331.htm

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

FORM 10-Q

 

(Mark One)

x

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

For the quarterly period ended March 31, 2016

OR

o

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

 

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 Web site, 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, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer

 

o

  

Accelerated filer

 

o

 

 

 

 

Non-accelerated filer

 

o  (Do not check if a small reporting company)

  

Small reporting company

 

x

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

As of May 13, 2016, the registrant had 38,230,459 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.

Condensed Consolidated Financial Statements (Unaudited)

 

4

 

 

 

 

 

Condensed Consolidated Balance Sheets

 

4

 

 

 

 

 

Condensed Consolidated Statements of Operations

 

5

 

 

 

 

 

Condensed Consolidated Statements of Cash Flows

 

6

 

 

 

 

 

Notes to Condensed Consolidated Financial Statements

 

7

 

 

 

 

Item 2.

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

 

18

 

 

 

 

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

 

28

 

 

 

 

Item 4.

Controls and Procedures

 

28

 

 

 

 

 

PART II – OTHER INFORMATION

 

 

 

 

 

 

Item 1.

Legal Proceedings

 

29

 

 

 

 

Item 1A.

Risk Factors

 

29

 

 

 

 

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

 

60

 

 

 

 

Item 3.

Defaults Upon Senior Securities

 

61

 

 

 

 

Item 4.

Mine Safety Disclosures

 

61

 

 

 

 

Item 5.

Other Information

 

61

 

 

 

 

Item 6.

Exhibits

 

61

 

 

 

 

 

Signatures

 

62

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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 “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 commercially viable 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 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:

 

·

market acceptance of MRI-guided radiation therapy;

 

·

the benefits of MRI-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 MRI-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;

 

·

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

 

·

our financial performance;

 

·

our expectations related to the MRIdian linac technology;

 

·

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.  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)

 

 

 

March 31,

2016

 

 

December 31,

2015

 

 

 

(Unaudited)

 

 

 

 

 

ASSETS

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

5,729

 

 

$

20,667

 

Accounts receivable

 

 

 

 

 

830

 

Inventory

 

 

11,916

 

 

 

8,073

 

Deposits on purchased inventory

 

 

3,552

 

 

 

3,936

 

Deferred cost of revenue

 

 

3,895

 

 

 

8,782

 

Prepaid expenses and other current assets

 

 

1,371

 

 

 

1,329

 

Total current assets

 

 

26,463

 

 

 

43,617

 

Property and equipment, net

 

 

11,413

 

 

 

7,306

 

Restricted cash

 

 

943

 

 

 

943

 

Intangible assets, net

 

 

154

 

 

 

200

 

Other assets

 

 

92

 

 

 

91

 

TOTAL ASSETS

 

$

39,065

 

 

$

52,157

 

LIABILITIES AND STOCKHOLDERS’

   DEFICIT

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

6,655

 

 

$

4,358

 

Accrued liabilities

 

 

5,109

 

 

 

5,413

 

Customer deposits

 

 

9,390

 

 

 

12,763

 

Deferred revenue, current portion

 

 

5,889

 

 

 

5,616

 

Total current liabilities

 

 

27,043

 

 

 

28,150

 

Long-term debt

 

 

29,091

 

 

 

29,016

 

Deferred revenue, net of current portion

 

 

429

 

 

 

345

 

Other long-term liabilities

 

 

2,263

 

 

 

1,603

 

TOTAL LIABILITIES

 

 

58,826

 

 

 

59,114

 

Commitments and contingencies (Note 6)

 

 

 

 

 

 

 

 

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

   authorized at March 31, 2016 (unaudited) and December 31, 2015; no shares issued and

   outstanding at March 31, 2016 (unaudited) and December 31, 2015

 

 

 

 

 

 

Stockholders’ deficit:

 

 

 

 

 

 

 

 

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

   March 31, 2016 (unaudited) and December 31, 2015; 38,216,523 and

   38,204,960 shares issued and outstanding at March 31, 2016 (unaudited) and

   December 31, 2015

 

 

372

 

 

 

372

 

Additional paid-in capital

 

 

190,276

 

 

 

189,712

 

Accumulated deficit

 

 

(210,409

)

 

 

(197,041

)

TOTAL STOCKHOLDERS’ DEFICIT

 

 

(19,761

)

 

 

(6,957

)

TOTAL LIABILITIES AND STOCKHOLDERS’

   DEFICIT

 

$

39,065

 

 

$

52,157

 

 

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

4


VIEWRAY, INC.

Condensed Consolidated Statements of Operations

(In thousands, except share and per share data)

(Unaudited)

 

 

 

Three Months Ended March 31,

 

 

 

2016

 

 

2015

 

Revenue:

 

 

 

 

 

 

 

 

Product

 

$

5,240

 

 

$

99

 

Service

 

 

216

 

 

 

181

 

Total revenue

 

 

5,456

 

 

 

280

 

Cost of revenue:

 

 

 

 

 

 

 

 

Product

 

 

5,927

 

 

 

154

 

Service

 

 

601

 

 

 

623

 

Total cost of revenue

 

 

6,528

 

 

 

777

 

Gross margin

 

 

(1,072

)

 

 

(497

)

Operating expenses:

 

 

 

 

 

 

 

 

Research and development

 

 

3,399

 

 

 

2,248

 

Selling and marketing

 

 

1,279

 

 

 

964

 

General and administrative

 

 

6,320

 

 

 

4,323

 

Total operating expenses

 

 

10,998

 

 

 

7,535

 

Loss from operations

 

 

(12,070

)

 

 

(8,032

)

Interest income

 

 

1

 

 

 

1

 

Interest expense

 

 

(1,082

)

 

 

(484

)

Other income (expense), net

 

 

(217

)

 

 

60

 

Loss before provision for income taxes

 

$

(13,368

)

 

$

(8,455

)

Provision for income taxes

 

 

 

 

 

 

Net loss attributable to common stockholders

 

$

(13,368

)

 

$

(8,455

)

Net loss per share attributable to common stockholders, basic

   and diluted

 

$

(0.35

)

 

$

(9.27

)

Weighted-average common shares used to compute net loss per

   share attributable to common stockholders, basic and diluted

 

 

38,211,439

 

 

 

911,922

 

 

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

5


VIEWRAY, INC.

Condensed Consolidated Statements of Cash Flows

(In thousands)

(Unaudited)

 

 

 

Three Months Ended March 31,

 

 

 

2016

 

 

2015

 

CASH FLOWS FROM OPERATING ACTIVITIES:

 

 

 

 

 

 

 

 

Net loss

 

$

(13,368

)

 

$

(8,455

)

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

 

 

 

 

 

 

 

 

Depreciation and amortization

 

 

372

 

 

 

288

 

Stock-based compensation

 

 

556

 

 

 

74

 

Accretion on asset retirement obligation

 

 

9

 

 

 

 

Change in fair value of convertible preferred stock warrant liability

 

 

 

 

 

(66

)

Loss on disposal of property and equipment

 

 

2

 

 

 

 

Inventory lower of cost or market adjustment

 

 

235

 

 

 

 

Amortization of debt discount and interest accrual

 

 

462

 

 

 

115

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Accounts receivable

 

 

830

 

 

 

904

 

Inventory

 

 

(4,261

)

 

 

913

 

Deposits on purchased inventory

 

 

384

 

 

 

(686

)

Deferred costs

 

 

4,887

 

 

 

(3,619

)

Prepaid expenses and other assets

 

 

(43

)

 

 

(508

)

Accounts payable

 

 

1,957

 

 

 

(2,853

)

Accrued expenses and other long-term liabilities

 

 

504

 

 

 

(401

)

Customer deposits and deferred revenue

 

 

(3,016

)

 

 

4,690

 

Net cash used in operating activities

 

 

(10,490

)

 

 

(9,604

)

CASH FLOWS FROM INVESTING ACTIVITIES:

 

 

 

 

 

 

 

 

Purchase of property and equipment

 

 

(4,456

)

 

 

(489

)

Net cash used in investing activities

 

 

(4,456

)

 

 

(489

)

CASH FLOWS FROM FINANCING ACTIVITIES:

 

 

 

 

 

 

 

 

Proceeds from issuance of convertible notes, net

 

 

 

 

 

15,729

 

Payments of long-term debt

 

 

 

 

 

(1,328

)

Payment of offering costs related to common stock private placement

 

 

 

 

 

(272

)

Proceeds from the exercise of stock options

 

 

8

 

 

 

8

 

Net cash provided by financing activities

 

 

8

 

 

 

14,137

 

NET INCREASE (DECREASE) IN CASH

 

 

(14,938

)

 

 

4,044

 

CASH — BEGINNING OF PERIOD

 

 

20,667

 

 

 

11,129

 

CASH — END OF PERIOD

 

$

5,729

 

 

$

15,173

 

SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION:

 

 

 

 

 

 

 

 

Cash paid for interest

 

$

621

 

 

$

379

 

Cash paid for taxes

 

$

 

 

$

 

SUPPLEMENTAL NON-CASH INVESTING AND FINANCING ACTIVITIES:

 

 

 

 

 

 

 

 

Purchase of fixed assets in accounts payable and accrued expenses

 

$

932

 

 

$

28

 

Transfer of fixed assets from inventory

 

$

1,728

 

 

$

 

Offering cost in accounts payable and accrued expenses

 

$

 

 

$

1,216

 

 

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

6


VIEWRAY, INC.

Notes to Condensed Consolidated Financial Statements

(Unaudited)

 

 

1.

Background and Organization

On July 8, 2015, ViewRay, Inc. (f/k/a Mirax Corp.), or ViewRay, we, us, our or the Company, completed a 1.185763-for-1 forward stock split of our common stock in the form of a dividend with the result that 4,343,339 shares of common stock, par value $0.001 per share, outstanding immediately prior to the stock split became 5,150,176 shares of common stock, par value $0.001 per share, outstanding immediately thereafter. On July 15, 2015, we changed our name to ViewRay, Inc. by filing the Certificate of Amendment to our Articles of Incorporation. Additionally, on July 21, 2015, we changed our domicile from the State of Nevada to the State of Delaware by reincorporation, or the Conversion, and as a result of the Conversion, increased our authorized capital stock from 75,000,000 shares of common stock, par value $0.001 per share, to 300,000,000 shares of common stock, par value $0.01 per share and 10,000,000 shares of “blank check” preferred stock, par value $0.01 per share.

On July 23, 2015, the Company and ViewRay Technologies, Inc. (f/k/a ViewRay Incorporated) consummated an Agreement and Plan of Merger and Reorganization, or Merger Agreement. Pursuant to the Merger Agreement, the stockholders of ViewRay Technologies, Inc. contributed all of their equity interests to the Company for shares of the Company’s common stock and merged with the Company’s subsidiary, which resulted in ViewRay Technologies, Inc. becoming a wholly-owned subsidiary of the Company, or the Merger.

On August 17, 2015, we completed the third and final closing of a private placement offering, or the Private Placement, through which we sold an aggregate of 5,884,504 shares of our common stock at a purchase price of $5.00 per share and raised a total of $26.3 million, net of offering costs.

The Merger was accounted for as a reverse-merger and recapitalization.  ViewRay Technologies, Inc. is the acquirer for the financial reporting purposes and ViewRay, Inc. is the acquired company under the acquisition method of accounting.  Consequently, the assets, liabilities and operations that were reflected in the historical consolidated financial statements prior to the Merger became those of ViewRay Technologies, Inc. and were recorded at the historical cost basis, and the condensed consolidated financial statements after completion of the Merger included the assets, liabilities and results of operations of ViewRay Technologies, Inc. up to the day prior to the closing of the Merger and the assets, liabilities and results of operations of the combined company from and after the closing date of the Merger.  

On March 31, 2016, the Company’s shares of common stock commenced trading on the Nasdaq Global Market under the symbol “VRAY.”  Prior to this time, the Company’s common stock was quoted on the OTC Markets, OTCQB tier of OTC Markets Group, Inc. under the same symbol.  

ViewRay, Inc. and its wholly-owned subsidiary ViewRay Technologies, Inc., designs, manufactures and markets MRIdian, the first and only MRI-guided radiation therapy system to image and treat cancer patients simultaneously.

Since inception, ViewRay Technologies, Inc. has devoted substantially all of its efforts towards research and development, initial selling and marketing activities, raising capital and preparing for the manufacturing and shipment of MRIdian systems. In May 2012, ViewRay Technologies, Inc. was granted clearance from the U.S. Food and Drug Administration, or FDA, to sell MRIdian. In November 2013, ViewRay Technologies, Inc. received its first clinical acceptance of a MRIdian at a customer site, and the first patient was treated with that system in January 2014. Since November 2014, ViewRay Technologies, Inc. has the right to affix the CE mark to MRIdian.

 

The Company’s condensed consolidated financial statements have been prepared on the basis of the Company continuing as a going concern for a reasonable period of time.  The Company’s principal sources of liquidity are cash flows from investment capital and available borrowings under its Term Loan agreement.  These have historically been sufficient to meet working capital needs, capital expenditures, and debt service obligations.  During the quarter ended March 31, 2016, the Company incurred a net loss from operations of $12.1 million and used cash from operations of $10.5 million.  The Company plans that it will have sufficient cash flows from its operations to continue as a going concern; however, these plans rely on certain underlying assumptions and estimates that may differ from actual results.  Such assumptions include FDA approval of the Company’s MRIdian linac technology, which may broaden the Company’s addressable market, accelerate the Company’s sales cycle, accelerate backlog conversion time and improve gross margins.  The Company’s plans also include the ability to execute Amendment No. 1 to the Capital Royalty Partners, L.P. debt agreement (see Note 5, Debt) to provide access to an additional $15.0 million of working capital.  On May 9, 2016, the Company drew down the first $5.0 million and expects to receive the remaining $10.0 million on or about May 20, 2016. The Company expects that its existing cash and cash equivalents, together with cash receipts from sales of MRIdian systems, the additional draw down from the

7


CRG Term Loan and the plan to raise additional financing from various sources from time to time will enable the Company to conduct its planned operations for at least the next 12 months.

2.

Summary of Significant Accounting Policies

The accompanying condensed consolidated financial statements reflect the application of certain significant accounting policies, as described below and elsewhere in the accompanying notes to the condensed consolidated financial statements.

Basis of Presentation

The condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America, or GAAP, and pursuant to the rules and regulation of the Securities and Exchanges Commission, or SEC. The condensed consolidated financial statements include the accounts of ViewRay, Inc. and its wholly-owned subsidiary, ViewRay Technologies, Inc.  All inter-company accounts and transactions have been eliminated in consolidation.

In the opinion of management, all adjustments, including normal recurring adjustments, considered necessary for a fair presentation of the Company’s unaudited condensed consolidated financial statements have been included. The results of operations for the three months ended March 31, 2016 are not necessarily indicative of the results that may be expected for the year ending December 31, 2016 or any future period. These unaudited condensed consolidated financial statements and notes thereto should be read in conjunction with the audited consolidated financial statements and notes thereto for the year ended December 31, 2015.

The significant accounting policies used in preparation of these condensed consolidated financial statements are disclosed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2015 filed with the SEC on March 28, 2016, and have not changed significantly since such filing.  

Use of Estimates

The preparation of the condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported and disclosed in the condensed consolidated financial statements and accompanying notes. Such estimates include, but are not limited to, allocation of revenue to its multiple deliverable elements, inventory write-downs to reflect lower of cost and market value, assumptions used in the valuation of stock-based awards and a convertible preferred stock warrant and valuation allowances against deferred tax assets. Actual results could differ from those estimates.

Inventory Valuation

Inventory consists primarily of purchased components for assembling MRIdian systems and other direct costs associated with MRIdian system installation. Inventory is stated at the lower of cost (on a weighted-average basis) or market value. When the net realizable value of the inventory is lower than related costs, we reduce the carrying value of the inventory for the difference while recording a corresponding charge to cost of product revenues. The assumptions we used in estimating the net realizable value of the inventory primarily include the total cost to complete the applicable MRIdian system.

Recent Accounting Pronouncements

In May 2014, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update (ASU) 2014-09, Revenue from Contracts with Customers (Topic 606), which supersedes the revenue recognition requirements in Accounting Standards Codification 605, Revenue Recognition. This ASU is based on the principle that revenue is recognized to depict the transfer of goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. The ASU also requires additional disclosure about the nature, amount, timing and uncertainty of revenues and cash flows arising from customer contracts, including significant judgments and changes in judgments and assets recognized from costs incurred to obtain or fulfill a contract. In August 2015, the FASB issued ASU 2015-14, which provides a one-year deferral in the effective date of ASU 2014-09. Early adoption will be permitted, but not earlier than the original effective date for annual and interim periods. In accordance with the deferral, the effective date applicable to the Company will be the first quarter of fiscal 2018. The Company has not yet selected a transition method and is currently evaluating the effect that the updated standard will have on its consolidated financial statements and related disclosures.

In August 2014, the FASB issued ASU 2014-15, Presentation of Financial Statements—Going Concern (Subtopic 205-40), which requires management to assess if there is substantial doubt about an entity’s ability to continue as a going concern and to provide related footnote disclosures in certain circumstances.  In connection with each annual and interim period, management must assess if there is substantial doubt about an entity’s ability to continue as a going concern within one year after the financial statement issuance date.  Disclosures are required if conditions give rise to substantial doubt.  The new standard is effective for all entities in the first annual period ending after December 31, 2016.  The Company has not elected to early adopt this accounting pronouncement.  

8


In April 2015, the FASB issued ASU 2015-03, Simplifying the Presentation of Debt Issuance Costs, which requires all debt issuance costs be presented in the balance sheet as a direct deduction from the carrying value of the associated debt. Under ASU 2015-03, the presentation of debt issuance costs is consistent with the presentation for a debt discount, which is a direct adjustment to the carrying value of the debt. Accordingly, the amortization of such costs should continue to be calculated using the interest method and be reported as interest expense. ASU 2015-03 is effective for fiscal years beginning after December 15, 2015, and interim periods therein. Early application is permitted. The Company has elected to early adopt this guidance and recorded the debt issuance cost related to the CRG Term Loan as a debt discount. The adoption also did not result in a retrospective restatement of our financial statements as there were no significant historical debt issuance costs incurred in prior periods that were not accounted for as a debt discount.  The CRG debt issuance cost is amortized to interest expense during the life of the Term Loan using the effective interest method. See Note 5, Debt.

In July 2015, the FASB issued ASU 2015-11, Simplifying the Measurement of Inventory, which requires entities to measure most inventory at the lower of cost and net realizable value, thereby simplifying the current guidance under which an entity must measure inventory at the lower of cost or market. ASU 2015-11 is effective prospectively for annual periods beginning after December 15, 2016 and interim periods therein. Early application is permitted. The Company is reviewing the provisions of ASU 2015-11 and expects that the new guidance will not have a material impact on its financial reporting.

In November 2015, the FASB issued ASU 2015-17, Balance Sheet Classification of Deferred Taxes, which eliminates the current requirement for an entity to separate deferred income tax liabilities and assets into current and non-current amounts in the consolidated balance sheets. To simplify the presentation of deferred income taxes, the amendments in this ASU require that deferred tax liabilities and assets be classified as non-current in the consolidated balance sheets. ASU 2015-17 is effective for annual periods beginning after December 15, 2017 and interim periods therein. Early application is permitted. The Company is currently evaluating adoption methods and whether this standard will have a material impact on its financial reporting.

In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842), which supersedes the Accounting Standards Codification 840, Leases. This ASU requires lessees to begin recognize all leases, with exception of short-term lease, as a lease liability on the balance sheet. Under this ASU, a lease is defined as a lessee’s obligation to make lease payments arising from a lease, measured on a discounted basis, and a right-of-use asset which is an asset that represents the lessee’s right to use, or control the use of, a specified asset during the lease term. The ASU also requires additional disclosure about the amount, timing and uncertainty of cash flow from leases. The new standard is effective for fiscal years beginning after December 15, 2018, and interim periods therein. Early adoption is permitted. The Company is currently evaluating the effect the new standard will have on its consolidated financial statements and related disclosure.

In March 2016, the FASB issued ASU 2016-09, Compensation – Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting, which simplifies several aspects of the accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities, and classification on the statement of cash flows.  ASU 2016-09 is effective for fiscal years beginning after December 15, 2016, and interim periods within those fiscal therein.  Early adoption is permitted.  The Company is currently evaluating the impact of adoption on its consolidated financial statements and related disclosure.  

In April 2016, the FASB issued ASU 2016-10, Identifying Performance Obligations and Licensing, that amends the revenue guidance in ASU 2014-09 on identifying performance and accounting for licenses of intellectual property.  ASU 2016-10 changed the FASB’s previous proposals on renewals of right-of-use licenses and contractual licenses and contractual restrictions.  The effective date of this standard for the Company will coincide with ASU 2014-09 during the first quarter of fiscal 2018.  The Company is currently evaluating the effect that the updated standard will have on its consolidated financial statements and related disclosures.  

9


3.

Balance Sheet Components

Property and Equipment

Property and equipment consisted of the following (in thousands):

 

 

 

March 31,

2016

 

 

December 31,

2015

 

 

 

(Unaudited)

 

 

 

 

 

Prototype

 

$

6,476

 

 

$

6,492

 

Machinery and equipment

 

 

8,871

 

 

 

7,128

 

Leasehold improvements

 

 

1,524

 

 

 

1,532

 

Furniture and fixtures

 

 

359

 

 

 

350

 

Software

 

 

866

 

 

 

832

 

Construction in progress

 

 

4,506

 

 

 

1,851

 

Property and equipment, gross

 

 

22,602

 

 

 

18,185

 

Less: accumulated depreciation and amortization

 

 

(11,189

)

 

 

(10,879

)

Property and equipment, net

 

$

11,413

 

 

$

7,306

 

 

Depreciation and amortization expense related to property and equipment were $326 thousand and $246 thousand during the three months ended March 31, 2016 and 2015, respectively.

Intangible Assets

Intangible assets consisted of the following (in thousands):

 

 

 

March 31,

2016

 

 

December 31,

2015

 

 

 

(Unaudited)

 

 

 

 

 

License cost

 

$

500

 

 

$

500

 

Patents

 

 

104

 

 

 

104

 

Intangible assets, gross

 

$

604

 

 

$

604

 

Accumulated amortization

 

 

(450

)

 

 

(404

)

Intangible assets, net

 

$

154

 

 

$

200

 

 

Intangible amortization expense were $46 thousand and $42 thousand during the three months ended March 31, 2016 and 2015, respectively, which were recorded in general and administrative expenses in the condensed consolidated statements of operations.

At March 31, 2016, the estimated future amortization expense of purchased intangible assets was as follows (in thousands):

 

Year Ending December 31,

 

Estimated Future

Amortization

Expense

 

 

 

(Unaudited)

 

The remainder of 2016

 

$

69

 

2017

 

 

18

 

2018

 

 

18

 

2019

 

 

18

 

2020

 

 

18

 

2021

 

 

13

 

Thereafter

 

 

 

Total amortization expense

 

$

154

 

 

10


Accrued Liabilities

Accrued liabilities consisted of the following (in thousands):

 

 

 

March 31,

2016

 

 

December 31,

2015

 

 

 

(Unaudited)

 

 

 

 

 

Accrued payroll and related benefits

 

$

2,205

 

 

$

1,938

 

Accrued accounts payable

 

 

1,055

 

 

 

1,880

 

Sales tax and medical device excise tax payable

 

 

343

 

 

 

219

 

Accrued legal and accounting

 

 

813

 

 

 

857

 

Other

 

 

693

 

 

 

519

 

Total accrued liabilities

 

$

5,109

 

 

$

5,413

 

 

Deferred Revenue

Deferred revenue consisted of the following (in thousands):

 

 

 

March 31,

2016

 

 

December 31,

2015

 

 

 

(Unaudited)

 

 

 

 

 

Deferred revenue:

 

 

 

 

 

 

 

 

Product

 

$

5,050

 

 

$

5,050

 

Services

 

 

1,268

 

 

 

911

 

Total deferred revenue

 

 

6,318

 

 

 

5,961

 

Less: current portion of deferred revenue

 

 

(5,889

)

 

 

(5,616

)

Noncurrent portion of deferred revenue

 

$

429

 

 

$

345

 

 

 

4.

Fair Value of Financial Instruments

The Company’s financial instruments that are carried at fair value mainly consist of Level 1 assets and Level 3 liabilities. Level 1 assets include highly liquid bank deposits and money market funds, which were not material at March 31, 2016 and December 31, 2015. Level 3 liabilities that are measured on a recurring basis consist of the convertible preferred stock warrant liability. The convertible preferred stock warrant liability was valued using the Black-Scholes option-pricing model. Generally, increases (decreases) in the fair value of the underlying stock and estimated term would result in a directionally similar impact to the fair value of the warrant (see Note 8).

The convertible preferred stock warrants were issued in December 2013 and in July 2015, upon the closing of the Merger, the convertible preferred stock warrants were converted into warrants to purchase the Company’s common stock. The aggregate fair value of these warrants upon the closing of the Merger was $93 thousand, which was reclassified from liabilities to common stock additional paid-in-capital, a component of the condensed consolidated stockholder’s deficit, and the Company ceased recording further related periodic fair value change adjustments.

During the three months ended March 31, 2015, the Company recorded a change in fair value of financial liabilities of $66 thousand.  At March 31, 2016, the Company had no change in fair value of financial liabilities.  

The gains and losses from re-measurement of Level 3 financial liabilities are recorded as part of other income (expense), net in the condensed consolidated statements of operations.

5.

Debt

 

Hercules Term Loan

In December 2013, ViewRay Technologies, Inc. entered into a Loan and Security Agreement, or the Hercules Term Loan, with Hercules Technology Growth Capital, Inc. and Hercules Technology III, L.P., or together, Hercules, for $15.0 million that was outstanding at December 31, 2014. Borrowings under the Hercules Term Loan bear cash interest at the greater of the annual prime rate plus 7.0% or 10.25%, which was 10.25% at December 31, 2014. In addition, borrowings under the Hercules Term Loan bear deferred payment in-kind interest at 1.5% per annum. Interest only payments began in January 2014, with monthly principal and interest payments beginning on January 1, 2015 and the entire balance of the Hercules Term Loan are to be paid in full by the June 1, 2017

11


maturity date. The Hercules Term Loan is subject to a prepayment penalty of 5% on the outstanding balance during the first 12 months following the funding of the loan and 1% on the outstanding balance thereafter until maturity. The Hercules Term Loan was issued at a discount of $466 thousand, which was amortized to interest expense during the life of the loan using the effective interest method. The discount included the fair value of a convertible preferred stock warrant that was issued with the Hercules Term Loan, as discussed in the following paragraph, and the related transaction costs. The Hercules Term Loan is collateralized by essentially all the assets of ViewRay Technologies, Inc. and limits its ability with respect to additional indebtedness, investments or dividends, among other things, subject to customary exceptions.

In connection with the issuance of the Hercules Term Loan, ViewRay Technologies, Inc. entered into a Warrant Agreement with Hercules to issue a fully-vested and exercisable warrant to purchase 128,231 shares of Series C convertible preferred stock with an exercise price of $5.84 per share. The warrant is exercisable any time before the later of 10 years from issuance or five years after an IPO. The warrant provides for anti-dilution rights on the Series C convertible preferred stock, which includes one-time down-round protection. The fair value of the warrant upon issuance of $158 thousand was recorded as convertible preferred stock warrant liability and a discount to the carrying value of the Hercules Term Loan. The fair value of the warrant at the time of issuance was estimated using the Black-Scholes option-pricing model with the following assumptions: expected term of two years, expected volatility of 30%, risk-free interest rate of 0.4% and expected dividend yield of 0%. See Note 8 for assumptions used to estimate the fair value of convertible preferred stock warrant liability upon conversion into warrants to purchase common stock and at December 31, 2014.

In June 2015, ViewRay Technologies, Inc. paid off in full the outstanding balances on Hercules Term Loan, including the related interest and other penalty fee, using part of the proceeds received from the CRG Term Loan discussed below.

 

CRG Term Loan

 

In June 2015, ViewRay Technologies, Inc. entered into a Term Loan Agreement, or the CRG Term Loan, with Capital Royalty Partners II L.P., Capital Royalty Partners II – Parallel Fund “A” L.P., Capital Royalty Partners II (Cayman) L.P. and Parallel Investment Opportunities Partners II L.P. or together with their successors by assignment, CRG, for up to $50.0 million of which $30.0 million was made available to us upon closing with the remaining $20.0 million to be available on or before June 26, 2016 at our option upon the occurrence of either (i) an initial public offering of our common stock on a nationally recognized securities exchange that raises a minimum of $40.0 million in net cash proceeds with a minimum of $120.0 million post-money valuation, or Qualifying IPO, or (ii) achievement of a minimum of $25.0 million gross revenue from the sales of the MRIdian system during any consecutive 12 months before March 31, 2016. We drew down the first $30.0 million on closing date. The CRG Term Loan has a maturity date of June 26, 2020 and bears cash interest at a rate of 12.5% per annum to be paid quarterly during the interest-payment-only period of 3 years. The interest-payment-only period can be extended for another year until June 26, 2019 if the Company completes an underwritten public offering on or before June 26, 2018. During the interest-payment-only period, the Company has the option to elect to pay only 8% of the 12.5% per annum interest in cash, and the remaining 4.5% of the 12.5% per annum interest as compounded interest, or deferred payment in-kind interest, added to the aggregate principal amount of the CRG Term Loan. Principal payment and any deferred payment in-kind interest will be paid quarterly in equal installments following the end of the interest-payment-only period through maturity date.

In March 2016, the Company and CRG executed an amendment to the original terms of the CRG Term Loan such that, with regard to the conditions for borrowing the remaining $20.0 million available under the CRG Term Loan, the Company may, at its election, draw down (i) an amount of either $10.0 million or $15.0 million in up to two advances upon achievement of a minimum of $15.0 million or aggregate product and service revenue during any consecutive 12 month period ending on or before March 31, 2016 and (ii) an additional $5.0 million (or $10.0 million, if the previous draw made was only in an amount of $10.0 million) upon achievement of a minimum of $25.0 million of aggregate product and service revenue during any consecutive 12 month period ending on or before December 31, 2016 and upon execution of the first sales contract of the Company’s second generation product.  At March 31, 2016, the Company achieved the minimum of $15.0 million gross revenue requirement which makes the first $15.0 million of the remaining $20.0 million immediately available for draw down by the Company.

In April 2016, the Company provided CRG with a Notice of Borrowing to draw down the $15.0 million available amount.  The Company received the first $5.0 million on May 9, 2016 and expects to receive the remaining $10.0 million on or about May 20, 2016.

The CRG Term Loan is subject to a prepayment penalty of 3% on the outstanding balance during the first 12 months following the funding of the Term Loan, 2% on the outstanding balance after year 1 but on or before year 2, 1% on the outstanding balance after year 2 but on or before year 3, and 0% on the outstanding loan if prepaid after year 3 thereafter until maturity. The Term Loan is also subject to a facility fee of 7% based on the sum of the amount drawn and any outstanding payment in-kind interest payable on maturity date or the date such loan becomes due. All direct financing costs were accounted for as a discount on the CRG Term Loan and will be amortized to interest expense during the life of the loan using the effective interest method. The CRG Term Loan is subject to financial covenants and is collateralized by essentially all our assets of the Company and limits its ability with respect to additional indebtedness, investments or dividends, among other things, subject to customary exceptions.

12


 

6.

Commitments and Contingencies

Operating Leases

The Company leases office space in Oakwood Village, Ohio and Mountain View, California under non-cancellable operating leases. At March 31, 2016, the future minimum payments for the operating leases are as follows (in thousands):

 

Year Ending December 31,

 

Future Minimum

Payments

 

The remainder of 2016

 

$

837

 

2017

 

 

1,106

 

2018

 

 

963

 

2019

 

 

823

 

2020 and thereafter

 

 

 

Total future minimum payments

 

$

3,729

 

 

Contingencies

The Company is subject to claims and assessments from time to time in the ordinary course of business. The Company records a provision for a liability when it believes that it is both probable that a liability has been incurred and the amount can be reasonably estimated. Significant judgment is required to determine both probability and the estimated amount.

In the normal course of business, the Company may become involved in legal proceedings. The Company will accrue a liability for such matters when it is probable that a liability has been incurred and the amount can be reasonably estimated. When only a range of possible loss can be established, the most probable amount in the range is accrued. If no amount within this range is a better estimate than any other amount within the range, the minimum amount in the range is accrued. The accrual for a litigation loss contingency might include, for example, estimates of potential damages, outside legal fees and other directly related costs expected to be incurred. At March 31, 2016 and December 31, 2015, the Company was not involved in any material legal proceedings.

Purchase Commitments

At March 31, 2016 and December 31, 2015, the Company had no outstanding firm purchase commitments.

 

 

7.

Convertible Preferred Stock

In January 2015, ViewRay Technologies, Inc. issued an aggregate of 162,407 shares of Series C convertible preferred stock to a new investor at a price of $5.84 per share for a total gross consideration of $950 thousand.

In February 2015, ViewRay Technologies, Inc. issued 2,564,652 shares of Series C convertible preferred stock to another investor at a price of $5.84 per share for total gross consideration of $15.0 million.

In July 2015, upon the closing of the Merger, all of ViewRay Technologies, Inc.’s 30,381,987 shares of outstanding convertible preferred stock were converted into the Company’s common stock at a 1:1 conversion rate.  As a result, the Company had no convertible preferred stock issued and outstanding as of March 31, 2016 and December 31, 2015.  

8.

Warrants

In connection with the Hercules Term Loan (see Note 5, Debt), the Company issued a warrant to purchase 128,231 shares of Series C convertible preferred stock. The convertible preferred stock warrant was recorded as a liability and is adjusted to fair value at each balance sheet date, with the change in fair value being recorded as a component of other income (expense), net in the condensed consolidated statements of operations. Upon issuance, the fair value of the warrant was estimated to be $158 thousand.  The Company recorded a gain of $66 thousand related to the change in fair value of preferred stock warrant liability as part of other income (expense), net in the accompanying condensed consolidated statements of operations for the three months ended March 31, 2015.  

13


The Company used Black-Scholes option-pricing model to estimate the fair value of the convertible preferred stock with the following assumptions:

 

 

March 31,

2015

 

Series C Warrant:

 

 

 

 

Expected term (in years)

 

0.5 – 1.2

 

Expected volatility

 

 

25.0%

 

Risk-free interest rate

 

0.3% – 0.6%

 

Expected dividend yield

 

 

0%

 

Upon the closing of the Merger on July 23, 2015, all shares of Series C convertible preferred stock were converted into common stock, and the warrant to purchase Series C convertible preferred stock was converted into the warrant to purchase 128,231 shares of the Company’s common stock.  As a result, the fair value of the preferred stock warrant liability of $93 thousand was reclassified into additional paid-in capital.  At March 31, 2016 and December 31, 2015, the warrant had not been exercised and was still outstanding.

In connection with the Merger and the Private Placement, in July and August 2015, the Company issued warrants to purchase 198,760 shares of common stock at an exercise price of $5.00 per share to private placement agents as payment for services provided. These placement warrants are exercisable at any time at the option of the holder until the five year anniversary of its date of issuance.

The Company estimated the aggregate fair value of the placement warrants on the issuance date to be $316 thousand which was recorded in additional paid-in-capital as an offering cost against the total proceeds from the Private Placement.  The placement warrants were accounted for as equity awards.  At March 31, 2016 and December 31, 2015, the placement warrants had not been exercised and were still outstanding.  

 

The fair value of the placement warrants were valued at their grant dates using the Black-Scholes pricing model and the following weighted-average assumptions:

 

 

 

Upon Issuance

 

Preferred Stock Warrant:

 

 

 

 

Expected term (in years)

 

 

5.0

 

Expected volatility

 

 

31.8%

 

Risk-free interest rate

 

 

1.6%

 

Expected dividend yield

 

 

0%

 

 

 

9.

Stock-Based Compensation

A summary of the Company’s stock option activity and related information is as follows:

 

 

 

 

 

 

 

Options Outstanding

 

 

 

Shares

Available

for Grant

 

 

Number

of Stock

Options

Outstanding

 

 

Weighted-

Average

Exercise

Price

 

 

Weighted-

Average

Remaining

Contractual Life

(Years)

 

 

Aggregate

Intrinsic

Value

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(In thousands)

 

Balance at December 31, 2015

 

 

3,166,968

 

 

 

6,053,672

 

 

$

2.13

 

 

 

7.6

 

 

$

20,605

 

Granted (unaudited)

 

 

(34,380

)

 

 

34,380

 

 

 

4.90

 

 

 

 

 

 

 

 

 

Exercised (unaudited)

 

 

 

 

 

(11,563

)

 

 

0.74

 

 

 

 

 

 

 

 

 

Cancelled (unaudited)

 

 

21,020

 

 

 

(21,020

)

 

 

3.38

 

 

 

 

 

 

 

 

 

Balance at March 31, 2016 (unaudited)

 

 

3,153,608

 

 

 

6,055,469

 

 

$

2.15

 

 

 

7.4

 

 

$

14,637

 

Vested and exercisable at March 31, 2016 (unaudited)

 

 

 

 

 

 

3,459,650

 

 

$

1.09

 

 

 

6.3

 

 

$

11,302

 

Vested and expected to vest at March 31, 2016 (unaudited)

 

 

 

 

 

 

5,814,927

 

 

$

2.10

 

 

 

7.3

 

 

$

14,294

 

 

The weighted-average grant date fair value of options granted to employees was $3.06 and $4.08 per share during the three months ended March 31, 2016 and 2015, respectively. The grant date fair value of options vested was $444 thousand and $61 thousand during three months ended March 31, 2016 and 2015, respectively.

Aggregate intrinsic value represents the difference between the estimated fair value of the underlying common stock and the exercise price of outstanding, in-the-money options.  The aggregate intrinsic value of options exercised was insignificant during the three months ended March 31, 2016 and 2015.  

14


At March 31, 2016, total unrecognized compensation cost related to stock-based awards granted to employees, net of estimated forfeitures, was $4.8 million which is expected to be recognized over a weighted-average period of 3.0 years.

Determination of Fair Value

The determination of the fair value of stock options on the date of grant using an option-pricing model is affected by the estimated fair value of the Company’s common stock, as well as assumptions regarding a number of complex and subjective variables. The variables used to calculate the fair value of stock options using the Black-Scholes option-pricing model include actual and projected employee stock option exercise behaviors, expected price volatility of the Company’s common stock, the risk-free interest rate and expected dividends. Each of these inputs is subjective and generally requires significant judgment to determine.

Fair Value of Common Stock

Prior to the Merger, the fair value of the common stock underlying the stock-based awards was determined by ViewRay Technologies, Inc.’s board of directors, with input from management and third-party valuations. Post-Merger and up through March 30, 2016, our common stock shares were listed on the OTC Bulletin Board. Beginning March 31, 2016, our common stock shares were listed on The NASDAQ Global Market, or NASDAQ.  Fair value of the common stock is the adjusted closing price of the Company’s common stock on the trading date on these stock exchanges.

Expected Term

The expected term represents the period that the Company’s option awards are expected to be outstanding. The Company considers several factors in estimating the expected term of options granted, including the expected lives used by a peer group of companies within the Company’s industry that the Company considers to be comparable to its business and the historical option exercise behavior of its employees, which the Company believes is representative of future behavior.

Expected Volatility

As the Company does not have a sufficient trading history for its common stock, the expected stock price volatility for the Company’s common stock was estimated by taking the average historic price volatility for industry peers based on daily price observations over a period equivalent to the expected term of the stock option grants. Industry peers consist of several public companies in the Company’s industry which were the same as the comparable companies used in the common stock valuation analysis. The Company intends to continue to consistently apply this process using the same or similar public companies until a sufficient amount of historical information regarding the volatility of its own share price becomes available, or unless circumstances change such that the identified companies are no longer similar to the Company, in which case, more suitable companies whose share prices are publicly available would be used in the calculation.

Risk-Free Interest Rate

The risk-free interest rate is based on the zero coupon U.S. Treasury notes, with maturities similar to the expected term of the options.

Expected Dividend Yield

The Company does not anticipate paying any dividends in the foreseeable future and, therefore, uses an expected dividend yield of zero in the Black-Scholes option-valuation model.

In addition to the Black-Scholes assumptions discussed immediately above, the estimated forfeiture rate also has a significant impact on the related stock-based compensation. The forfeiture rate of stock options is estimated at the time of grant and revised in subsequent periods if actual forfeitures differ from those estimates. The Company uses historical data to estimate pre-vesting option forfeitures and records stock-based compensation expense only for those awards that are expected to vest.

15


The fair value of employee stock option was estimated at the date of grant using a Black-Scholes option-pricing model with the following weighted-average assumptions:  

 

 

 

Three Months

Ended March 31,

2016

 

Three Months

Ended March 31,

2015

 

 

 

(Unaudited)

 

Expected term (in years)

 

 

6.0

 

 

6.0

 

Expected volatility%

 

 

69.8%

 

 

52.3%

 

Risk-free interest rate%

 

 

1.5%

 

 

1.6%

 

Expected dividend yield%

 

 

0.0%

 

 

0.0%

 

 

Stock-Based Compensation Expense

Total stock-based compensation expense recognized in the Company’s condensed consolidated statements of operations is classified as follows (in thousands):

 

 

 

Three Months Ended March 31, 2016

 

 

 

2016

 

 

2015

 

 

 

(Unaudited)

 

Research and development

 

$

121

 

 

$

25

 

Selling and marketing

 

 

24

 

 

 

5

 

General and administrative

 

 

411

 

 

 

44

 

Total stock-based compensation expense

 

$

556

 

 

$

74

 

 

During the three months ended March 31, 2016 and 2015, there were no stock-based compensation expenses capitalized as a component of inventory or recognized in cost of revenue. Stock-based compensation relating to stock-based awards granted to consultants was insignificant for the three months ended March 31, 2016 and 2015.

 

 

16


10.

Income Tax

Due to the current operating losses, the Company recorded zero income tax expense for the three months ended March 31, 2016 and 2015, respectively.  During these periods, the Company’s activities were limited to U.S. federal and state tax jurisdictions, as it does not have any foreign operations.  The federal and state effective tax rate is approximately 37%.

Due to the Company’s history of cumulative losses, management concluded that, after considering all the available objective evidence, it is not more likely than not that all of the Company’s net deferred tax assets will be realized.  Accordingly, the Company’s deferred tax assets, which includes net operating loss, or NOL, carryforwards and tax credits related primarily to research and development continue to be subject to a valuation allowance as of March 31, 2016.  The Company will continue to maintain a full valuation allowance until there is sufficient evidence to support recoverability of its deferred tax assets.      

The Company had $742 thousand in unrecognized tax benefit at March 31, 2016 and December 31, 2015.  The reversal of the uncertain tax benefits would not affect the effective tax rate to the extent that the Company continues to maintain a full valuation allowance against its deferred tax assets.  Unrecognized tax benefits may change during the next 12 months for items that arise in the ordinary course of business.  

Interest and/or penalties related to income tax matters are recognized as a component of income tax expense.  At March 31, 2016, there were no accrued interest and penalties related to uncertain tax positions.  

 

11.

Net Loss per Share

The following weighted-average common stock equivalents were excluded from the calculation of diluted net loss per share for the periods presented because including them would have had an anti-dilutive effect:

 

 

 

Three Months Ended March 31,

 

 

 

2016

 

 

2015

 

 

 

(Unaudited)

 

Convertible preferred stock (if converted)

 

 

 

 

 

29,006,955

 

Options to purchase common stock

 

 

6,063,836

 

 

 

4,286,236

 

Preferred stock warrants (if converted)

 

 

 

 

 

128,231

 

Common stock warrants (if converted)

 

 

326,991

 

 

 

 

 

12.

Related Party Transactions

In December 2004, the Company entered into a licensing agreement with the University of Florida Research Foundation, or UFRF, whereby UFRF granted the Company a worldwide exclusive license to certain of UFRF’s patents in exchange for 33,652 shares of common stock and a 1% royalty from sales of products developed and sold by the Company utilizing the licensed patents.  

13.

Segment and Geographic Information

The Company has one business activity, which is radiation therapy technology combined with magnetic resonance imaging, and operates in one reportable segment.  The Company’s chief operating decision-maker, its chief executive officer, reviews its operating results on an aggregate basis for purposes of allocating resources and evaluating financial performance.  Also, the Company does not have segment managers as the Company manages its operations as a single operating segment.

 

14.

Subsequent Events

On April 25, 2016, the Company gave a Notice of Borrowing to CRG to draw down the $15.0 million available amount.  The Company received the first $5.0 million on May 9, 2016 and expects to receive the remaining $10.0 million on or about May 20, 2016.  

 

 

 

17


Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION

AND RESULTS OF OPERATIONS

The interim financial statements included in this Quarterly Report on Form 10-Q and this Management’s Discussion and Analysis of Financial Condition and Results of Operations should be read in conjunction with the financial statements and notes thereto for the year ended December 31, 2015, and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations, contained in the Annual Report filed with the SEC on March 28, 2016.  In addition to historical information, this discussion and analysis contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. These forward-looking statements are subject to risks and uncertainties, including those under “Risk Factors” in this Quarterly Report, that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements.

Unless otherwise indicated, references in this section to “ViewRay,” “we,” “us,” “our” and “the Company” refer to ViewRay, Inc. and its consolidated subsidiary, ViewRay Technologies, Inc.

As previously reported, on July 23, 2015, our wholly-owned subsidiary, Vesuvius Acquisition Corp., a corporation formed in the State of Delaware on July 16, 2015, or the Acquisition Sub, merged with and into ViewRay Technologies, Inc., a corporation incorporated in 2004 in the State of Florida originally under the name of ViewRay Incorporated, subsequently reincorporated in the State of Delaware in 2007. Pursuant to this transaction, or the Merger, ViewRay Technologies, Inc. was the surviving corporation and became our wholly-owned subsidiary. All of the outstanding capital stock of ViewRay Technologies, Inc. was converted into shares of our common stock, as described in more detail below.

Also as previously reported, immediately prior to the closing of the Merger, under the terms of a split-off agreement, or the Split-Off Agreement, and a general release agreement, we transferred all of its pre-Merger operating assets and liabilities to Acquisition Sub, or the Split-Off.

In connection with the Merger and pursuant to the Split-Off Agreement, we transferred our pre-Merger assets and liabilities to our pre-Merger majority stockholder, in exchange for the surrender and cancellation of 4,150,171 shares of our common stock.

As a result of the Merger and Split-Off, we discontinued our pre-Merger business, acquired the business of ViewRay Technologies, Inc. and continued the business operations of ViewRay Technologies, Inc., as a publicly-traded company under the name ViewRay, Inc.

As a result of the Merger and the change in business and operations of the Company, a discussion of the past financial results of the Company is not pertinent, and under applicable accounting principles the historical financial results of ViewRay Technologies, Inc., the accounting acquirer, prior to the Merger are considered the historical financial results of the Company.

The following discussion highlights ViewRay’s results of operations and the principal factors that have affected our financial condition as well as our liquidity and capital resources for the periods described, and provides information that management believes is relevant for an assessment and understanding of the statements of financial condition and results of operations presented herein. The following discussion and analysis are based on ViewRay’s unaudited consolidated financial statements contained in this Quarterly Report, which we have prepared in accordance with United States generally accepted accounting principles. You should read the discussion and analysis together with such consolidated financial statements and the related notes thereto.

Basis of Presentation

The unaudited condensed consolidated financial statements of ViewRay for the three months ended March 31, 2016 and 2015, contained herein include a summary of our significant accounting policies and should be read in conjunction with the discussion below. In the opinion of management, all material adjustments necessary to present fairly the results of operations for such periods have been included in these condensed consolidated financial statements. All such adjustments are of a normal recurring nature.

Company Overview

We design, manufacture and market MRIdian, the first and only MRI-guided radiation therapy system to image and treat cancer patients simultaneously. MRI is a broadly used imaging tool that has the ability to differentiate between types of soft tissue clearly, unlike X-ray or computed tomography, or CT, which are the most commonly used imaging technologies in radiation therapy today. MRIdian integrates MRI technology, radiation delivery and our proprietary software to locate, target and track the location and shape of soft-tissue tumors while radiation is delivered. These capabilities allow MRIdian to accurately deliver radiation to the tumor while

18


reducing the amount delivered to healthy tissue, as compared to other radiation therapy treatments today. We believe this leads to improved patient outcomes and reduced side effects from off-target radiation delivery.

We received initial 510(k) marketing clearance from the FDA for our treatment planning and delivery software in January 2011 and for MRIdian in May 2012. We also received permission to affix the CE mark in November 2014, allowing MRIdian to be sold within the European Economic Area. At March 31, 2016, patients had received radiation treatment on MRIdian systems at four cancer centers located at Washington University in St. Louis, University of California, Los Angeles, University of Wisconsin—Madison and Seoul National University in South Korea. In December 2015, the fifth MRIdian system was installed at the Sylvester Comprehensive Cancer Center at the University of Miami and patient treatment began there in April 2016.  In March 2016, the sixth MRIdian system was installed at the VU University Medical Center in Amsterdam, and is awaiting the start of patient treatment.  

We currently market MRIdian through a direct sales force in the United States and distributors in the rest of the world. We market MRIdian to a broad range of worldwide customers, including university research and teaching hospitals, community hospitals, private practices, government institutions and freestanding cancer centers. Our sales and revenue cycle varies based on the customer and can be lengthy, sometimes lasting up to 18 to 24 months or more from initial customer contact to sales contract execution. Following execution of a sales contract, it generally takes nine to 12 months for a customer to customize an existing facility or construct a new vault. After the customer completes their customization, it typically takes forty-five to ninety days for us to install MRIdian and perform on-site testing of the system, including the completion of acceptance test procedures.

We generated product and service revenue of $5.5 million and $0.3 million, and had net losses of $13.4 million and $8.5 million during the three months ended March 31, 2016 and 2015, respectively. At March 31, 2016, we had 16 signed orders representing a backlog value of $89.6 million.

We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future. We expect our expenses will increase substantially in connection with our ongoing activities, as we:

 

·

add personnel to support our product development and commercialization efforts;

 

·

continue our research and development efforts;

 

·

seek regulatory approval for MRIdian in foreign countries; and

 

·

operate as a public company.

Accordingly, we may seek to fund our operations through public or private equity, debt financings or other sources. However, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. Our failure to raise capital or enter into such other arrangements as and when needed would have a negative impact on our financial condition and our ability to develop enhancements to and integrate new technologies into MRI-guided radiation therapy systems.

New Orders and Backlog

New orders are defined as the sum of gross product orders recorded during the period.  We define backlog as the accumulation of all orders for which revenue has not been recognized and we consider valid. Backlog includes customer deposits or letters of credit.  Deposits received are recorded as a liability on the balance sheet. Orders may be revised or cancelled according to their terms or upon mutual agreement between the parties. Therefore, it is difficult to predict with certainty the amount of backlog that will ultimately result in revenue. The determination of backlog includes objective and subjective judgment about the likelihood of an order contract becoming revenue. We perform a quarterly review of backlog to verify that outstanding orders in backlog remain valid, and based upon this review, orders that are no longer expected to result in revenue are removed from backlog. Our criteria include an outstanding and effective written agreement for the delivery of a MRIdian signed by customers, receipt of a minimum customer deposit or a letter of credit, any changes in customer or distributor plans or financial conditions, the customer’s or distributor’s continued intent and ability to fulfill the order contract, changes to regulatory requirements, the status of regulatory approval required in the customer’s jurisdiction, if any, or reasons for cancellation of order contracts.

During the three months ended March 31, 2016, our new orders were $11.2 million. At March 31, 2016, we had 16 signed sales contracts for MRIdian systems in backlog with a total value of $89.6 million.

19


Components of Statements of Operations

Revenue

Product Revenue. Product revenue consists of sales of MRIdian systems, as well as optional components, such as additional planning workstations and body coils.

Following execution of a sales contract, it generally takes nine to 12 months for a customer to customize an existing facility or construct a new vault. Upon the commencement of installation at a customer’s facility, it typically takes forty-five to ninety days to complete the installation and on-site testing of the system, including the completion of acceptance test procedures. On-site training takes approximately one week and can be conducted concurrently with installation and acceptance testing. Sales contracts generally include customer deposits upon execution of the agreement, and in certain cases, additional amounts due at shipment or commencement of installation, and final payment due generally upon customer acceptance.

Service Revenue. We generally offer maintenance service at no cost to customers to cover parts, labor and maintenance for one to two years. In addition, we offer multi-year, post-installation maintenance and support contracts that provide various levels of service support, which enables our customers to select the level of on-going support services, including parts and labor, which they require. These post-installation contracts are for a period of one to five years and provide services ranging from 24/7 on-site parts and labor, and preventative maintenance to labor only with a longer response time. We also offer technology upgrades to our MRIdian systems, when and if available, for an additional fee. Service revenue is recognized on a straight-line basis over the term during which the contracted services are provided.

Cost of Revenue

Product Cost of Revenue. Product cost of revenue primarily consists of the cost of materials, installation and services associated with the manufacture and installation of MRIdian systems, as well as medical device excise tax and royalty payments to the University of Florida Research Foundation. Product cost of revenue also includes lower of cost or market inventory, or LCM, adjustments if the carrying value of the inventory is greater than its net realizable value. For strategic reasons, we initially sold our MRIdian systems prior to December 31, 2015 at prices lower than our projected costs to manufacture and install. As we accumulated materials, installation and other costs for these systems, we regularly assessed the carrying value of the related inventory value and recorded charges, or LCM adjustments, to reduce inventory to the lower of cost and net realizable value. The remaining realizable value of inventory was charged to product cost of revenue as those initial sites were completed and accepted.  Since January 1, 2016 and the receipt of FDA marketing clearance, we have been able to increase sales prices and lower our cost; however, for the three months ended March 31, 2016, costs exceeded revenue, resulting in LCM charges of $235 thousand as compared to $0 for the three months ended March 31, 2015. LCM charges were higher in 2016 since the majority of the LCM charges related to the two MRIdian systems installed in the three months ended March 31, 2015 were already recorded in 2014 when the systems were built.

We expect our materials, installation and service costs to decrease as we continue to scale our operations, improve product designs and work with our third-party suppliers to lower costs.  In addition, we have increased sales prices for MRIdian systems. We expect to continue to lower costs and increase sales prices as we transition to the MRIdian linac technology.  

Service Cost of Revenue. Service cost of revenue is comprised primarily of personnel costs, training and travel expenses to service and maintenance of installed MRIdian systems. Service cost of revenue also includes the costs of replacement parts under maintenance and support contracts.

Operating Expenses

Research and Development. Research and development expenses consist primarily of compensation and related costs for personnel, including stock-based compensation, employee benefits and travel. Other significant research and development costs arise from development, manufacturing and commercialization of MRIdian. These costs consist of third-party consulting services, laboratory supplies, research materials, medical equipment, computer equipment and licensed technology, and related depreciation and amortization. We expense research and development expenses as incurred. As we continue to invest in improving MRIdian and developing new technologies, we expect research and development expenses to increase in absolute dollars.

Selling and Marketing. Selling and marketing expenses consist primarily of compensation and related costs for personnel, including stock-based compensation, employee benefits and travel associated with our selling and marketing organization, including our direct sales force and sales management and our marketing and customer support personnel. Selling and marketing expenses also include costs related to trade shows and marketing programs. We expense selling and marketing costs as incurred. We expect selling and marketing expenses to increase in future periods as we expand our sales force and our marketing and customer support organization and increase our participation in trade shows and marketing programs.

20


General and Administrative. Our general and administrative expenses consist primarily of compensation and related costs for personnel, including stock-based compensation, employee benefits and travel, and for our operations, finance, human resources, regulatory and other administrative personnel. In addition, general and administrative expenses include third-party consulting, legal, audit, accounting services, quality and regulatory functions and facilities costs, and gain or loss on the disposal of property and equipment. While we expect administrative and finance related expenses to remain generally flat, general and administrative expenses related to operations and quality and regulatory functions are likely to increase in absolute dollars due to the costs associated with the development of linac technology as well as growth in the business and costs associated with being a public company.

Interest Income

Interest income consists primarily of interest income received on our cash and cash equivalents.

Interest Expense

Interest expense consists primarily of interest and amortization of the debt discount related to our long-term debt entered in 2013 from Hercules Technology III, L.P. and Hercules Technology Growth Capital, Inc., or together, Hercules, convertible promissory notes issued in 2014 and long-term debt entered in 2015 from Capital Royalty II L.P., Capital Royalty Partners II – Parallel Fund “A” L.P., Capital Royalty Partners II (Cayman) L.P. and Parallel Investment Opportunities Partners II L.P., or together with their successors by assignment, CRG, and such loan the CRG Term Loan.

Other Income (Expense), Net

Other income (expense), net consists primarily of foreign currency exchange gains and losses and changes in the fair value of a convertible preferred stock warrant.

The outstanding convertible stock warrant is re-measured to fair value at each balance sheet date with the corresponding gain or loss from the adjustment recorded as a component of other income (expense), net. In July 2015, upon the closing of the Merger, the convertible preferred stock warrants were converted into warrants to purchase common stock. The aggregate fair value of these warrants upon the closing of the Merger was reclassified from liabilities to additional paid-in-capital, a component of stockholders’ deficit, and we no longer recorded the change in fair value adjustments.

21


Results of Operations

The following tables set forth our results of operations for the periods presented (in thousands):

 

 

 

Three Months Ended March 31,

 

 

 

2016

 

 

2015

 

 

 

(Unaudited)

 

Revenue:

 

 

 

 

 

 

 

 

Product

 

$

5,240

 

 

$

99

 

Service

 

 

216

 

 

 

181

 

Total revenue

 

 

5,456

 

 

 

280

 

Cost of revenue:

 

 

 

 

 

 

 

 

Product

 

 

5,927

 

 

 

154

 

Service

 

 

601

 

 

 

623

 

Total cost of revenue

 

 

6,528

 

 

 

777

 

Gross margin

 

 

(1,072

)

 

 

(497

)

Operating expenses:

 

 

 

 

 

 

 

 

Research and development

 

 

3,399

 

 

 

2,248

 

Selling and marketing

 

 

1,279

 

 

 

964

 

General and administrative

 

 

6,320

 

 

 

4,323

 

Total operating expenses:

 

 

10,998

 

 

 

7,535

 

Loss from operations

 

 

(12,070

)

 

 

(8,032

)

Interest income

 

 

1

 

 

 

1

 

Interest expense

 

 

(1,082

)

 

 

(484

)

Other income (expense), net

 

 

(217

)

 

 

60

 

Loss before provision for income taxes

 

 

(13,368

)

 

 

(8,455

)

Provision for income taxes

 

 

 

 

 

 

Net loss

 

$

(13,368

)

 

$

(8,455

)

 

Comparison of the Three Months Ended March 31, 2016 and 2015

Revenue

 

 

 

Three Months Ended March 31,

 

 

 

 

 

 

 

2016

 

 

2015

 

 

Change

 

 

 

(in thousands)

 

 

 

 

 

Product

 

$

5,240

 

 

$

99

 

 

$

5,141

 

Service

 

 

216

 

 

 

181

 

 

 

35

 

Total revenue

 

$

5,456

 

 

$

280

 

 

$

5,176

 

 

Total revenue during the three months ended March 31, 2016 increased $5.2 million compared to the three months ended March 31, 2015. The increase was primarily due to revenue on one MRIdian system installed in March 2016 compared to selling components in the three months ended March 31, 2015.

Product Revenue. Product revenue during the three months ended March 31, 2016 increased $5.1 million compared to the three months ended March 31, 2015. The increase was primarily due to $5.2 million of MRIdian system revenue recognized in the three months ended March 31, 2016 related to VU University Medical Center in Amsterdam compared to $0.1 million due to delivery of certain components to customers during the three months ended March 31, 2015.

Service Revenue. Service revenue increased $35 thousand during the three months ended March 31, 2016 compared to the three months ended March 31, 2015.

22


Cost of Revenue

 

 

 

Three Months Ended March 31,

 

 

 

 

 

 

 

2016

 

 

2015

 

 

Change

 

 

 

(in thousands)

 

 

 

 

 

Product

 

$

5,927

 

 

$

154

 

 

$

5,773

 

Service

 

 

601

 

 

 

623

 

 

 

(22

)

Total cost of revenue

 

$

6,528

 

 

$

777

 

 

$

5,751

 

 

Product Cost of Revenue. Product cost of revenue increased $5.8 million during the three months ended March 31, 2016 compared to the three months ended March 31, 2015 primarily due to the installation of a MRIdian system at VU University Medical Cancer Center in Amsterdam.

Service Cost of Revenue. Service cost of revenue decreased $22 thousand during the three months ended March 31, 2016 compared to the three months ended March 31, 2015.  

Operating Expenses

 

 

 

Three Months Ended March 31,

 

 

 

 

 

 

 

2016

 

 

2015

 

 

Change

 

 

 

(in thousands)

 

 

 

 

 

Research and development

 

$

3,399

 

 

$

2,248

 

 

$

1,151

 

Selling and marketing

 

 

1,279

 

 

 

964