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): November 13, 2017
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)
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
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 Instructions 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)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
Item 2.02Results of Operations and Financial Condition.
On November 13, 2017, ViewRay, Inc. issued a press release announcing its financial results for the fiscal quarter ended September 30, 2017. 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 Exchange Act, or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of 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 |
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: November 13, 2017 |
By:/s/ Chris A. Raanes |
Exhibit 99.1
ViewRay Reports Third Quarter 2017 Financial Results
Strong Order Momentum in Q3, continuing in Q4
CLEVELAND, OH November 13, 2017 — ViewRay, Inc. (Nasdaq: VRAY) today announced financial results for the third quarter and nine months ended September 30, 2017.
Third Quarter & Recent Financial Highlights:
|
|
• |
Total revenue of $12.2 million in Q3 2017, up from $0.4 million in Q3 2016. |
|
|
• |
Received new orders for MRIdian Linac systems in Q3 2017 totaling $29.9 million, compared to orders totaling $24.5 million in Q3 2016. |
|
|
• |
Total backlog grew to $194.8 million, as of September 30, 2017, up from $125.2 million as of September 30, 2016. This is net of one cancellation received in Q3 2017. |
|
|
• |
Awarded a tender offer for two MRIdian Linacs in Copenhagen and one MRIdian Linac in Zurich in October. |
|
|
• |
Raised gross proceeds of approximately $50 million through sale of 8,382,643 shares of common stock in a direct registered offering in October. |
Third Quarter 2017 MRIdian Clinical Highlights:
|
|
• |
Completed first patient treatments on the MRIdian Linac at Henry Ford Hospital in Michigan |
|
|
• |
Strong presence at AAPM and ASTRO annual meetings with 51 presentations highlighting MRIdian's growing role in cancer care. |
|
|
• |
Announced multi-center prospective clinical trial for locally advanced unresectable pancreatic cancer following early retrospective clinical data suggesting nearly 2X prolonged median survival using MRIdian adaptive therapy. |
|
|
• |
Held inaugural meeting of ViewRay’s Clinical Cooperative Think Tank (C2T2), comprised of leading clinicians from 18 institutions around the world, focused on gathering evidence of the benefits of MR-guided radiation therapy. |
“In the third quarter we completed the installation of 2 MRIdian Linac systems and saw strong momentum in new orders for the MRIdian Linac,” said Chris A. Raanes, president and chief executive officer of ViewRay. "This momentum has continued into Q4, including winning competitive tenders for 3 new MRIdian Linacs at two sites in Europe in October. We also strengthened our cash position by raising $50 million to support the expanding commercialization of the MRIdian Linac.”
Financial Results
Total revenue for the third quarter ended September 30, 2017 was $12.2 million, compared to $0.4 million for the same period last year, including the recognition of revenue from two new MRIdian systems in the third quarter of 2017. Total revenue for the nine months ended September 30, 2017 was $14.1 million, compared to $6.1 million for the same period last year.
Cost of product revenue was $9.7 million for the third quarter ended September 30, 2017, compared to $0.8 million for the same period last year. Total gross profit (loss) for the third quarter ended September 30, 2017 was $2.0 million, compared to $(0.8) million for the same period last year. Cost of product revenue was $10.3 million for the nine months ended September 30, 2017, compared to $6.9 million for the same period last year. Total gross profit (loss) for the nine months ended September 30, 2017 was $2.0 million, compared to $(2.5) million for the same period last year.
Total operating expenses for the third quarter ended September 30, 2017 were $13.6 million, compared to $10.1 million for the same period last year. Total operating expenses for the nine months ended September 30, 2017 were $37.4 million, compared to $31.2 million for the same period last year.
Net loss for the third quarter ended September 30, 2017 was $(11.2) million, or $(0.19) per share, compared to $(14.1) million, or $(0.35) per share, for the same period last year. Net loss for the nine months ended September 30, 2017 was
$(47.5) million, or $(0.85) per share, compared to $(39.6) million, or $(1.02) per share, for the same period last year. The net loss in the third quarter and nine months ended September 30, 2017 included $2.3 million of other income and $6.9 million of other expense, respectively, primarily from changes in the fair value of warrant liabilities.
ViewRay had total cash and cash equivalents of $34.4 million at September 30, 2017.
Financial Guidance
The Company is repeating its expectation to deliver 7 to 8 MRIdian Linac Systems in 2017, but is adjusting the total revenue to be in the range of $42 million to $47 million.
Conference Call and Webcast
ViewRay will hold a conference call on Monday, November 13, 2017 at 8:30 a.m. ET / 5:30 a.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 5588908. 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 14 days following the call. In addition, a telephonic replay of the call will be available until November 20, 2017. The replay dial-in numbers are (855) 859-2056 for domestic callers and (404) 537-3406 for international callers. Please use the conference ID number 5588908.
About ViewRay
ViewRay®, Inc. (Nasdaq: VRAY), designs, manufactures and markets the MRIdian® radiation therapy system. MRIdian is built upon a proprietary high-definition MR imaging system designed from the ground up to address the unique challenges and clinical workflow for advanced radiation oncology. Unlike MR systems used in diagnostic radiology, MRIdian’s high-definition MR was purposely built to deliver high-precision radiation without unnecessary beam distortion, and consequently, help to mitigate skin toxicity and other safety concerns that may otherwise arise when high magnetic fields interact with radiation beams. 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, the rate of new orders, upgrades and installations, ViewRay’s financial guidance for the full year 2017 and ViewRay’s conference call to discuss its third quarter 2017 financial results. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the timing, results and other uncertainties associated with clinical trials, 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 System, competition in the industry in which ViewRay operates and overall market conditions. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to ViewRay's business in general, see ViewRay's current and future reports filed with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2016 and its Quarterly Report on Form 10-Q for the quarter ended September 30, 2017. 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.
|
Investor Relations: |
|
Media Enquiries: |
|
Ajay Bansal |
|
Michael Saracen |
|
Chief Financial Officer |
|
Vice President, Marketing |
|
1-844-MRIdian (674-3426) |
|
Phone: +1 408-242-2994 |
|
|
|
Email: media@viewray.com |
Condensed Consolidated Statements of Operations
(In thousands, except share and per share data)
(Unaudited)
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||
|
|
|
2017 |
|
|
2016 |
|
|
2017 |
|
|
2016 |
|
||||
|
Gross Orders |
|
$ |
29,850 |
|
|
$ |
24,500 |
|
|
$ |
79,460 |
|
|
$ |
52,780 |
|
|
Backlog |
|
$ |
194,769 |
|
|
$ |
125,240 |
|
|
$ |
194,769 |
|
|
$ |
125,240 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product |
|
$ |
11,358 |
|
|
$ |
— |
|
|
$ |
11,358 |
|
|
$ |
5,240 |
|
|
Service |
|
|
721 |
|
|
|
298 |
|
|
|
2,408 |
|
|
|
813 |
|
|
Distribution Rights |
|
|
118 |
|
|
|
59 |
|
|
|
356 |
|
|
|
59 |
|
|
Total revenue |
|
|
12,197 |
|
|
|
357 |
|
|
|
14,122 |
|
|
|
6,112 |
|
|
Cost of revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product |
|
|
9,728 |
|
|
|
803 |
|
|
|
10,322 |
|
|
|
6,869 |
|
|
Service |
|
|
484 |
|
|
|
380 |
|
|
|
1,758 |
|
|
|
1,705 |
|
|
Total cost of revenue |
|
|
10,212 |
|
|
|
1,183 |
|
|
|
12,080 |
|
|
|
8,574 |
|
|
Gross margin |
|
|
1,985 |
|
|
|
(826 |
) |
|
|
2,042 |
|
|
|
(2,462 |
) |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
3,616 |
|
|
|
2,654 |
|
|
|
9,781 |
|
|
|
9,017 |
|
|
Selling and marketing |
|
|
2,510 |
|
|
|
1,570 |
|
|
|
5,453 |
|
|
|
4,251 |
|
|
General and administrative |
|
|
7,502 |
|
|
|
5,829 |
|
|
|
22,116 |
|
|
|
17,937 |
|
|
Total operating expenses |
|
|
13,628 |
|
|
|
10,053 |
|
|
|
37,350 |
|
|
|
31,205 |
|
|
Loss from operations |
|
|
(11,643 |
) |
|
|
(10,879 |
) |
|
|
(35,308 |
) |
|
|
(33,667 |
) |
|
Interest income |
|
|
1 |
|
|
|
1 |
|
|
|
3 |
|
|
|
2 |
|
|
Interest expense |
|
|
(1,843 |
) |
|
|
(1,707 |
) |
|
|
(5,372 |
) |
|
|
(4,166 |
) |
|
Other income (expense), net |
|
|
2,269 |
|
|
|
(1,561 |
) |
|
|
(6,853 |
) |
|
|
(1,798 |
) |
|
Loss before provision for income taxes |
|
$ |
(11,216 |
) |
|
$ |
(14,146 |
) |
|
$ |
(47,530 |
) |
|
$ |
(39,629 |
) |
|
Provision for income taxes |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
Net loss |
|
$ |
(11,216 |
) |
|
$ |
(14,146 |
) |
|
$ |
(47,530 |
) |
|
$ |
(39,629 |
) |
|
Net loss per share, basic and diluted |
|
$ |
(0.19 |
) |
|
$ |
(0.35 |
) |
|
$ |
(0.85 |
) |
|
$ |
(1.02 |
) |
|
Weighted-average common shares used to compute net loss per share attributable to common stockholders, basic and diluted |
|
|
59,061,149 |
|
|
|
40,156,851 |
|
|
|
56,064,562 |
|
|
|
38,915,156 |
|
Condensed Consolidated Balance Sheets
(In thousands, except share and per share data)
|
|
|
September 30, 2017 |
|
|
December 31, 2016(1) |
|
||
|
|
|
(Unaudited) |
|
|
|
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
34,413 |
|
|
$ |
14,198 |
|
|
Accounts receivable |
|
|
1,042 |
|
|
|
4,200 |
|
|
Inventory |
|
|
18,453 |
|
|
|
8,082 |
|
|
Deposits on purchased inventory |
|
|
6,115 |
|
|
|
2,522 |
|
|
Deferred cost of revenue |
|
|
10,390 |
|
|
|
3,909 |
|
|
Prepaid expenses and other current assets |
|
|
5,091 |
|
|
|
3,023 |
|
|
Total current assets |
|
|
75,504 |
|
|
|
35,934 |
|
|
Property and equipment, net |
|
|
11,318 |
|
|
|
11,560 |
|
|
Restricted cash |
|
|
1,143 |
|
|
|
1,143 |
|
|
Intangible assets, net |
|
|
82 |
|
|
|
97 |
|
|
Other assets |
|
|
86 |
|
|
|
30 |
|
|
TOTAL ASSETS |
|
$ |
88,133 |
|
|
$ |
48,764 |
|
|
LIABILITIES AND STOCKHOLDERS’ DEFICIT |
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
6,799 |
|
|
$ |
4,980 |
|
|
Accrued liabilities |
|
|
9,040 |
|
|
|
6,334 |
|
|
Customer deposits |
|
|
20,920 |
|
|
|
19,400 |
|
|
Deferred revenue, current portion |
|
|
10,873 |
|
|
|
6,515 |
|
|
Total current liabilities |
|
|
47,632 |
|
|
|
37,229 |
|
|
Deferred revenue, net of current portion |
|
|
3,215 |
|
|
|
3,918 |
|
|
Long-term debt |
|
|
44,458 |
|
|
|
44,290 |
|
|
Warrant liabilities |
|
|
12,835 |
|
|
|
2,723 |
|
|
Other long-term liabilities |
|
|
6,568 |
|
|
|
4,257 |
|
|
TOTAL LIABILITIES |
|
|
114,708 |
|
|
|
92,417 |
|
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
|
Stockholders’ deficit: |
|
|
|
|
|
|
|
|
|
Preferred stock, par value $0.01 per share; 10,000,000 shares authorized at September 30, 2017 (unaudited) and December 31, 2016; no shares issued and outstanding at September 30, 2017 (unaudited) and December 31, 2016 |
|
|
— |
|
|
|
— |
|
|
Common stock, par value of $0.01 per share; 300,000,000 shares authorized at September 30, 2017 (unaudited) and December 31, 2016; 59,071,653 and 43,581,184 shares issued and outstanding at September 30, 2017 (unaudited) and December 31, 2016 |
|
|
581 |
|
|
|
426 |
|
|
Additional paid-in capital |
|
|
268,051 |
|
|
|
203,598 |
|
|
Accumulated deficit |
|
|
(295,207 |
) |
|
|
(247,677 |
) |
|
TOTAL STOCKHOLDERS’ DEFICIT |
|
|
(26,575 |
) |
|
|
(43,653 |
) |
|
TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT |
|
$ |
88,133 |
|
|
$ |
48,764 |
|
(1) The condensed consolidated balance sheet as of December 31, 2016 was derived from audited financial statements as of that date.