FDA 510(k) Clearance of MRIdian Linac in February Follows Strong 2016
Company Provides 2017 Financial Guidance
CLEVELAND, OH March 16, 2017 — ViewRay, Inc. (Nasdaq: VRAY) today announced financial results for the fourth quarter and full year ended December 31, 2016.
Fourth Quarter 2016 Highlights:
Total revenue of $16.1 million, up from $4.6 million in Q4 2015
Received 4 new orders for MRIdian Systems, totaling $24.3 million, up from 2 orders totaling $11.3 million in Q4 2015
Total backlog grew to $133.2 million, representing 23 signed sales contracts, as of December 31, 2016, up from $84.4 million, representing 15 signed sales contracts, as of December 31, 2015
Full Year 2016 Highlights:
Total revenue of $22.2 million, up from $10.4 million in 2015
Received 13 new orders for MRIdian Systems, totaling $77.0 million, up from 7 new orders totaling $40.1 million 2015
Completed $26.1 million private placement in January 2017
Raised $21.9 million from the sale of 3.884 million shares of common stock through “at the market offerings” in February and March 2017
“2016 was a transformative year for ViewRay, highlighted by the development of our MRIdian Linac System and expansion of our backlog and installed base,” said Chris A. Raanes, president and chief executive officer of ViewRay. “Moving forward, we expect the recent FDA clearance of our MRIdian Linac System and the growing body of clinical evidence on the benefits of the MRIdian System to be significant catalysts for new orders and installations. On the operational side, we expect installations of our MRIdian Linac Systems to significantly improve our gross margins.”
Total revenue for the fiscal fourth quarter ended December 31, 2016 was $16.1 million, compared to $4.6 million for the same period last year. Total revenue for the full year 2016 was $22.2 million, compared to $10.4 million for the full year 2015.
Cost of product revenue was $17.0 million for the fiscal quarter ended December 31, 2016, compared to $6.4 million for the same period last year. Cost of product revenue was $23.9 million for the full year 2016, compared to $12.7 million for the full year 2015.
Total gross profit (loss) for the fiscal quarter ended December 31, 2016 was $(1.2) million, compared to $(2.2) million for the same period last year. Total gross profit (loss) for the full year 2016 was $(3.6) million, compared to $(4.2) million for the full year 2015.
Total operating expenses for the fiscal quarter ended December 31, 2016 were $9.3 million, compared to $10.8 million for the same period last year. Total operating expenses for the full year 2016 were $40.5 million, compared to $37.3 million for the same period last year.
Net loss for the fiscal quarter ended December 31, 2016 was $(11.0) million, or $(0.25) per share, compared to $(14.1) million, or $(0.37) per share, for the same period last year. Net loss for the full year 2016 was $(50.6) million, or $(1.26) per share, compared to $(45.0) million, or $(2.58) per share, for the full year 2015.
ViewRay had total cash and cash equivalents of $14.2 million at December 31, 2016.
For the full year 2017, ViewRay anticipates total revenue to be in the range of $45 million to $50 million, primarily from 7 to 8 MRIdian Linac Systems.
“With FDA clearance in hand, we have started ramping up procurement for the new generation systems and have begun installing the first MRIdian Linac systems,” said Ajay Bansal, Chief Financial Officer of ViewRay. “We expect to recognize revenue for these systems in the second half of 2017 upon system completion and acceptance.”
Conference Call and Webcast
ViewRay will hold a conference call on Thursday, March 16, 2017 at 4:30 p.m. ET / 1:30 p.m. PT. The dial-in numbers are (844) 277-1426 for domestic callers and (336) 525-7129 for international callers. The conference ID number is 68851407. 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 March 23, 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 68851407.
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.
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 and installations, the improvement of ViewRay’s gross margins, the benefits of the MRIdian System’s MRI-guided radiation therapy, ViewRay’s financial guidance for the full year 2017 and ViewRay’s conference call to discuss its fourth quarter and full year 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 System, 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 atwww.sec.gov.
Chief Financial Officer
Senior Director, Marketing
Phone: +1 408-242-2994
Condensed Consolidated Statements of Operations
(In thousands, except share and per share data)
|Three Months Ended December 31,||Year Ended December 31,|
|Cost of revenue:|
|Total cost of revenue||17,292||6,843||25,866||14,544|
|Research and development||2,425||3,041||11,442||10,449|
|Selling and marketing||1,350||1,824||5,601||5,139|
|General and administrative||5,566||5,906||23,503||21,685|
|Total operating expenses||9,341||10,771||40,546||37,273|
|Loss from operations||(10,508||)||(13,002||)||(44,175||)||(41,427||)|
|Other income (expense), net||1,286||(28||)||(512||)||(117||)|
|Loss before provision for income taxes||$||(11,007||)||$||(14,105||)||$||(50,636||)||$||(44,994||)|
|Provision for income taxes||—||1||—||1|
|Net loss per share, basic and diluted||$||(0.25||)||$||(0.37||)||$||(1.26||)||$||(2.58||)|
|Weighted-average common shares used to compute net loss per share attributable to common stockholders, basic and diluted||43,502,692||38,202,343||40,068,307||17,432,434|
Condensed Consolidated Balance Sheets
|Cash and cash equivalents||$||14,198||$||20,667|
|Deposits on purchased inventory||2,522||3,936|
|Deferred cost of revenue||3,909||8,782|
|Prepaid expenses and other current assets||3,023||1,329|
|Total current assets||35,934||43,617|
|Property and equipment, net||11,560||7,306|
|Intangible assets, net||97||200|
|LIABILITIES AND STOCKHOLDERS’ DEFICIT|
|Deferred revenue, current portion||6,515||5,616|
|Total current liabilities||37,229||28,150|
|Long-term debt, net||44,290||29,016|
|Deferred revenue, net of current portion||3,918||345|
|Other long-term liabilities||4,257||1,603|
|Commitments and contingencies|
|Convertible preferred stock, par value $0.01 per share; 10,000,000 shares authorized at December 31, 2016 and 2015; no shares issued and outstanding at December 31, 2016 and 2015||—||—|
|Common stock, par value of $0.01 per share; 300,000,000 shares authorized at December 31, 2016 and 2015; 43,581,184 and 38,204,960 shares issued and outstanding at December 31, 2016 and 2015||426||372|
|Additional paid-in capital||203,598||189,712|
|TOTAL STOCKHOLDERS’ DEFICIT||(43,653||)||(6,957||)|
|TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT||$||48,764||$||52,157|