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Form 8-K ViewRay, Inc. For: Aug 15

August 15, 2016 4:09 PM EDT

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 15, 2016

 

VIEWRAY, INC.

(Exact name of registrant as specified in its charter)

 

 

 

 

 

 

 

Delaware

 

001-37725

 

42-1777485

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification Number)

2 Thermo Fisher Way

Oakwood Village, Ohio 44146

(Address of principal executive offices, including zip code)

(440) 703-3210

(Registrant’s telephone number, including area code)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

¨Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 


 

Item 2.02

Results of Operations and Financial Condition.

On August 15, 2016, ViewRay, Inc. issued a press release announcing its financial results for the fiscal quarter ended June 30, 2016. The press release is attached hereto as Exhibit 99.1.

The information in this Item 2.02 of this Current Report on Form 8-K and the Exhibit 99.1 attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), or incorporated by reference in any filing of ViewRay, Inc. under the Securities Act or the Exchange Act, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

Item 7.01Regulation FD Disclosure.


The information set forth under Item 2.02 of this Current Report on Form 8-K is incorporated by reference into this Item 7.01.

The information in this Item 7.01 of this Current Report on Form 8-K and the Exhibit 99.1 attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), or incorporated by reference in any filing of ViewRay, Inc. under the Securities Act or the Exchange Act, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

Item 9.01Financial Statements and Exhibits.

 

(d)       Exhibits.

 

ExhibitNumber

Description

99.1

Press Release dated August 15, 2016.

 

 

 

 


 


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

VIEWRAY, INC.

Dated: August 15, 2016

By:/s/ Chris A. Raanes
Name:Chris A. Raanes
Title:Chief Executive Officer


 


EXHIBIT INDEX

 

ExhibitNumber

Description

99.1

Press Release dated August 15, 2016.

 

 

Exhibit 99.1

 

ViewRay Reports Second Quarter 2016 Financial Results

Company expects to submit MRIdian linac technology for FDA 510(k) clearance and CE Mark by end of 2016

Recent Highlights:

 

·

Received 3 new orders for MRIdian Systems, totaling $17.1 million; shipped one system

 

·

Total backlog of $100.7 million, representing 18 signed sales contracts, as of June 30, 2016

 

·

Extended cash runway with $15.0 million from term loan facility in May

 

·

Unique abilities of MRIdian to treat cancer patients were highlighted in 3 separate TV segments

 

·

ViewRay’s MRIdian System Receives Japanese Regulatory Approval (Shonin)

 

CLEVELAND, August 15, 2016 — ViewRay, Inc. (Nasdaq: VRAY) today announced financial results for the second quarter and six months ended June 30, 2016.

 

“We are making exciting progress, highlighted by the continued development of our MRIdian linac technology.  During site visits to assess the technology, clinicians and scientists have commented that they are particularly impressed by the sharpness of the beam and the high dose rate,” said Chris A. Raanes, President and Chief Executive Officer of ViewRay. “Recently, we presented the first technical data on the capabilities of MRIdian linac technology at the American Association of Physicists in Medicine in Washington DC. We anticipate presenting additional data on the MRIdian linac technology at the American Society for Radiation Oncology (ASTRO) annual meeting in September. We are on track with our linac development program and anticipate submitting for FDA 510(k) clearance and CE Mark in Europe by the end of the year.”

 

Mr. Raanes added, “We received three new orders in the second quarter, including our first order at a prestigious academic institution in Manhattan. As of June 30, 2016 our backlog exceeded $100 million, representing 18 signed sales contracts. We also shipped one MRIdian System in the quarter that we anticipate will be recognized as revenue upon completion of installation.  The unique abilities of the MRIdian System were recently highlighted in three different television segments.” These stories can be viewed on ViewRay’s website at http://www.viewray.com/in-the-news.

 

Financial Results

 

Total revenue for the fiscal quarter ended June 30, 2016 was $0.3 million, compared to $0.2 million for the same period last year. Total revenue for the six months ended June 30, 2016 was $5.8 million, compared to $0.5 million for the same period last year.

 

Cost of product revenue was $0.1 million for the fiscal quarter ended June 30, 2016, compared to $0.4 million for the same period last year. Total gross profit (loss) for the fiscal quarter ended June 30, 2016 was $(0.6) million, compared to $(0.7) million for the same period last year. Cost of product revenue was $6.1 million for the six months ended June 30, 2016, compared to $0.5 million for the same period last year. Total gross profit (loss) for the six months ended June 30, 2016 was $(1.6) million, compared to $(1.1) million for the same period last year.

 

Total operating expenses for the fiscal quarter ended June 30, 2016 were $10.2 million, compared to $10.7 million for the same period last year. Total operating expenses for the six months ended June 30, 2016 were $21.2 million, compared to $18.2 million for the same period last year.

 

Net loss for the second quarter ended June 30, 2016 was $(12.1) million, or $(0.32) per share, compared to $(12.2) million, or $(13.24) per share for the same period last year. Net loss for the six months ended June 30, 2016 was $(25.5) million, or $(0.67) per share, compared to $(20.6) million, or $(22.52) per share, for the same period last year.

 

ViewRay had total cash and cash equivalents of $9.4 million at June 30, 2016. In May 2016, ViewRay borrowed $15.0 million under its Term Loan Agreement with CRG.

 

 


Exhibit 99.1

 

Conference Call and Webcast

 

ViewRay will hold a conference call on Monday, August 15, 2016 at 4:30 p.m. ET / 1:30 p.m. PT to discuss the results. The dial-in numbers are 844-277-1426 for domestic callers and 336-525-7129 for international callers. The conference ID number is 60847362. A live webcast of the conference call will be available on the investor relations page of ViewRay’s corporate website at www.viewray.com.

After the live webcast, a replay of the webcast will remain available online on the investor relations page of ViewRay’s corporate website, www.viewray.com, for 90 days following the call. In addition, a telephonic replay of the call will be available until August 22, 2016. The replay dial-in numbers are 855-859-2056 for domestic callers and 404-537-3406 for international callers. Please use the replay pin number 60847362.

 

About ViewRay

 

ViewRay®, Inc. (Nasdaq: VRAY) designs, manufactures and markets the MRIdian® radiation therapy system. MRIdian integrates MRI technology, radiation delivery and proprietary software to locate, target and track the position and shape of soft-tissue tumors during radiation. ViewRay believes this combination of enhanced visualization and accuracy will significantly improve outcomes for patients.

 

The MRIdian linac is a technology under development and not available for sale or distribution in the United States. ViewRay and MRIdian are registered trademarks of ViewRay, Inc.

 

Forward Looking Statements:

 

This press release contains forward-looking statements. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, references to filing for regulatory approval of ViewRay’s MRIdian linac technology in the second half of 2016, the development of ViewRay’s MRIdian linac technology, the presentation of additional data at the ASTRO annual meeting in September, the recognition as revenue of the MRIdian System shipped in the second quarter of 2016 and ViewRay’s conference call to discuss its second quarter 2016 financial results. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to raise the additional funding needed to continue to pursue ViewRay’s business and product development plans, the inherent uncertainties associated with developing new products or technologies, the ability to commercialize MRIdian linac technology, competition in the industry in which ViewRay operates and overall market conditions. These forward-looking statements are made as of the date of this press release, and ViewRay assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents ViewRay files with the SEC available at www.sec.gov.

 

Contact:

 

Investor Relations:

Ajay Bansal

Chief Financial Officer

1-844-MRIdian (674-3426)

 

 


Exhibit 99.1

 

Media Enquiries:

Michael Saracen

Senior Director, Marketing

Phone: +1 440.703.3210, ext. 200

Email: [email protected]


 


Exhibit 99.1

 

VIEWRAY, INC.

Condensed Consolidated Statements of Operations

(In thousands, except share and per share data)

(Unaudited)

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2016

 

 

2015

 

 

2016

 

 

2015

 

Gross Orders

 

$

17,100

 

 

$

 

 

$

28,280

 

 

$

17,200

 

Backlog

 

$

100,740

 

 

$

71,860

 

 

$

100,740

 

 

$

71,860

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Product

 

$

 

 

$

 

 

$

5,240

 

 

$

99

 

Service

 

 

299

 

 

 

182

 

 

 

515

 

 

 

363

 

Total revenue

 

 

299

 

 

 

182

 

 

 

5,755

 

 

 

462

 

Cost of revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Product

 

 

139

 

 

 

391

 

 

 

6,066

 

 

 

545

 

Service

 

 

724

 

 

 

442

 

 

 

1,325

 

 

 

1,065

 

Total cost of revenue

 

 

863

 

 

 

833

 

 

 

7,391

 

 

 

1,610

 

Gross margin

 

 

(564

)

 

 

(651

)

 

 

(1,636

)

 

 

(1,148

)

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

2,964

 

 

 

2,258

 

 

 

6,363

 

 

 

4,506

 

Selling and marketing

 

 

1,402

 

 

 

1,227

 

 

 

2,681

 

 

 

2,191

 

General and administrative

 

 

5,788

 

 

 

7,174

 

 

 

12,108

 

 

 

11,497

 

Total operating expenses

 

 

10,154

 

 

 

10,659

 

 

 

21,152

 

 

 

18,194

 

Loss from operations

 

 

(10,718

)

 

 

(11,310

)

 

 

(22,788

)

 

 

(19,342

)

Interest income

 

 

 

 

 

 

 

 

1

 

 

 

1

 

Interest expense

 

 

(1,377

)

 

 

(839

)

 

 

(2,459

)

 

 

(1,323

)

Other income (expense), net

 

 

(20

)

 

 

(25

)

 

 

(237

)

 

 

35

 

Loss before provision for income taxes

 

$

(12,115

)

 

$

(12,174

)

 

$

(25,483

)

 

$

(20,629

)

Provision for income taxes

 

 

 

 

 

 

 

 

 

 

 

 

Net loss attributable to common stockholders

 

$

(12,115

)

 

$

(12,174

)

 

$

(25,483

)

 

$

(20,629

)

Net loss per share attributable to common stockholders, basic

   and diluted

 

$

(0.32

)

 

$

(13.24

)

 

$

(0.67

)

 

$

(22.52

)

Weighted-average common shares used to compute net loss per

   share attributable to common stockholders, basic and diluted

 

 

38,234,703

 

 

 

919,776

 

 

 

38,223,071

 

 

 

915,870

 

 

 

 


 


Exhibit 99.1

 

VIEWRAY, INC.

Condensed Consolidated Balance Sheets

(In thousands)

(Unaudited)

 

June 30,

2016

 

 

December 31,

2015 (1)

 

 

 

(Unaudited)

 

 

 

 

 

ASSETS

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

9,429

 

 

$

20,667

 

Accounts receivable

 

 

1,710

 

 

 

830

 

Inventory

 

 

11,193

 

 

 

8,073

 

Deposits on purchased inventory

 

 

2,877

 

 

 

3,936

 

Deferred cost of revenue

 

 

7,545

 

 

 

8,782

 

Prepaid expenses and other current assets

 

 

1,783

 

 

 

1,329

 

Total current assets

 

 

34,537

 

 

 

43,617

 

Property and equipment, net

 

 

12,238

 

 

 

7,306

 

Restricted cash

 

 

943

 

 

 

943

 

Intangible assets, net

 

 

120

 

 

 

200

 

Other assets

 

 

31

 

 

 

91

 

TOTAL ASSETS

 

$

47,869

 

 

$

52,157

 

LIABILITIES AND STOCKHOLDERS’

   DEFICIT

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

5,957

 

 

$

4,358

 

Accrued liabilities

 

 

5,154

 

 

 

5,413

 

Customer deposits

 

 

11,950

 

 

 

12,763

 

Deferred revenue, current portion

 

 

8,644

 

 

 

5,616

 

Total current liabilities

 

 

31,705

 

 

 

28,150

 

Long-term debt, net

 

 

44,135

 

 

 

29,016

 

Deferred revenue, net of current portion

 

 

302

 

 

 

345

 

Other long-term liabilities

 

 

2,812

 

 

 

1,603

 

TOTAL LIABILITIES

 

 

78,954

 

 

 

59,114

 

Commitments and contingencies (Note 6)

 

 

 

 

 

 

 

 

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

   authorized at June 30, 2016 (unaudited) and December 31, 2015; no shares issued and

   outstanding at June 30, 2016 (unaudited) and December 31, 2015

 

 

 

 

 

 

Stockholders’ deficit:

 

 

 

 

 

 

 

 

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

   June 30, 2016 (unaudited) and December 31, 2015; 38,362,134 and

   38,204,960 shares issued and outstanding at June 30, 2016 (unaudited) and

   December 31, 2015

 

 

374

 

 

 

372

 

Additional paid-in capital

 

 

191,065

 

 

 

189,712

 

Accumulated deficit

 

 

(222,524

)

 

 

(197,041

)

TOTAL STOCKHOLDERS’ DEFICIT

 

 

(31,085

)

 

 

(6,957

)

TOTAL LIABILITIES AND STOCKHOLDERS’

   DEFICIT

 

$

47,869

 

 

$

52,157

 

 

(1) The condensed consolidated balance sheet as of December 31, 2015 was derived from audited financial statements as of that date.

 



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