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): March 12, 2020
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) |
(IRS Employer Identification No.) |
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2 Thermo Fisher Way Oakwood Village, Ohio |
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44146 |
(Address of Principal Executive Offices) |
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(Zip Code) |
Registrant’s Telephone Number, Including Area Code: (440) 703-3210
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)) |
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
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Trading Symbol(s) |
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Name of each exchange on which registered |
Common Stock, par value $0.01 |
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VRAY |
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The Nasdaq Global Market |
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 2.02 Results of Operations and Financial Condition.
On March 12, 2020, ViewRay, Inc. (“ViewRay” or the “Company”) issued a press release announcing its financial results for the fourth quarter and fiscal year ended December 31, 2019. 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 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 7.01 Regulation FD Disclosure.
Spokespersons of ViewRay, Inc. (“ViewRay”) plan to present the information in the presentation attached hereto as Exhibit 99.2 to analysts and investors from time to time on or after March 12, 2020. The presentation will be available on the Investor Relations page at Company’s website at: http://investors.viewray.com.
The furnishing of the attached presentation is not an admission as to the materiality of any information therein. The information contained in the presentation is summary information that is intended to be considered in the context of more complete information included in ViewRay’s filings with the U.S. Securities and Exchange Commission (the “SEC”) and other public announcements that ViewRay has made and may make from time to time by press release or otherwise. ViewRay undertakes no duty or obligation to update or revise the information contained in this report, although it may do so from time to time as its management believes is appropriate. Any such updating may be made through the filing of other reports or documents with the SEC, through press releases or through other public disclosures. For important information about forward looking statements, see the slide titled “Forward-Looking Statements & Disclaimer” in Exhibit 99.2 attached hereto.
The information in this Item 7.01 of this Current Report on Form 8-K and the Exhibit 99.2 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 the Company 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 9.01 Financial Statements and Exhibits.
(d) Exhibits.
ExhibitNumber |
Description |
99.1 |
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99.2 |
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 thereunto duly authorized.
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VIEWRAY, INC. |
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Date: March 12, 2020 |
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By: |
/s/ Robert S. McCormack |
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Robert S. McCormack |
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Senior Vice President, General Counsel and Corporate Secretary |
Exhibit 99.1
ViewRay Reports Fourth Quarter and Full Year 2019 Results
CLEVELAND, March 12, 2020 — ViewRay, Inc. (Nasdaq: VRAY) today announced financial results for the fourth quarter and full year ended December 31, 2019. A supplemental presentation for today's conference call is included on the Company's website at http://investors.viewray.com/events/event-details/q4-2019-viewray-inc-earnings-conference-call.
Full Year 2019 Highlights:
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• |
Total revenue of $87.8 million compared to 2018 revenue of $81.0 million, which is primarily from 15 revenue units including two system upgrades in each respective year. |
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Received 22 new orders for MRIdian systems, including three upgrades, totaling $118.5 million, compared to 23 new orders totaling $140.7 million in 2018. |
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Total backlog increased to $227.3 million as of December 31, 2019, compared to $212.3 million as of December 31, 2018. |
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Cash and cash equivalents were $226.8 million as of December 31, 2019. The Company received aggregate net proceeds of $138.4 million, after deducting underwriting discounts and commissions and offering expenses payable by the Company, from its December 2019 offering. |
Fourth Quarter 2019 Summary:
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• |
Total revenue was $16.5 million in the quarter, primarily from three revenue units including one system upgrade, compared to $20.7 million, primarily from four revenue units including one system upgrade, for the same period last year. |
“In 2019 we built significant organizational expertise, made progress on our innovation and clinical pipelines, and fortified our balance sheet,” said Scott Drake, President and CEO. “As we look at 2020, our commercial and operational activities are being impacted by the coronavirus and may be further impacted depending upon how the situation unfolds. As we look beyond the coronavirus uncertainty, we are confident in the capabilities we have built and how MRIdian is positioned to improve the paradigm of care."
Financial Results
Total revenue for the three months ended December 31, 2019 was $16.5 million compared to $20.7 million for the same period last year. Total revenue for the full year 2019 was $87.8 million compared to $81.0 million for the full year 2018.
Total cost of revenue for the three months ended December 31, 2019 was $20.4 million compared to $20.1 million for the same period last year. Total cost of revenue was $93.3 million for the full year 2019 compared to $74.4 million for the full year 2018.
Total gross (loss) profit for the three months ended December 31, 2019 was $(3.9) million, compared to $0.6 million for the same period last year. Total gross (loss) profit for the full year 2019 was $(5.5) million compared to $6.6 million for the full year 2018.
Total operating expenses for the three months ended December 31, 2019 were $28.4 million, compared to $22.1 million for the same period last year. Total operating expenses for the full year 2019 were $115.3 million for the full year 2019 compared to $81.7 million for the full year 2018.
Net loss for the three months ended December 31, 2019 was $35.2 million, or $0.31 per share, compared to $16.7 million, or $0.17 per share, for the same period last year. Net loss for the full year 2019 was $120.2 million, or $1.18 per share, compared to $79.1 million, or $0.98 per share, for the full year 2018.
ViewRay had total cash and cash equivalents of $226.8 million at December 31, 2019. From its December 2019 offering, the Company received aggregate net proceeds of $138.4 million, after deducting underwriting discounts and commissions and offering expenses payable by the Company.
Financial Guidance
For the full year 2020, ViewRay anticipates total revenue to be in the range of $58 - $95 million, and total cash usage to be in the range of $60 - $80 million. Most notably, commercial and operational activities are being impacted and may be further impacted by the coronavirus. ViewRay has nine planned installations in 2020 in regions that have travel restrictions currently in place.
Conference Call and Webcast
ViewRay will hold a conference call to discuss results on Thursday, March 12, 2020 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 6095383. 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 March 19, 2020. 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 6095383.
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 purpose built to address specific challenges, including beam distortion, skin toxicity, and other concerns that potentially may 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 within the meaning of Section 27A of the Private Securities Litigation Reform Act. 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 2020 and ViewRay's conference calls to discuss its fourth quarter 2019 and year to date 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 commercialize MRIdian Linac System, demand for ViewRay's products, the ability to convert backlog into revenue, and the timing of delivery of ViewRay's products, 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, 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, 2019 and its 2019 Quarterly Reports on Form 10-Q, as updated periodically with the company's other filings with the SEC. 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.
Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
(In thousands, except share and per share data)
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Three Months Ended December 31, |
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Year Ended December 31, |
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2019 |
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2018 |
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2019 |
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2018 |
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Gross Orders |
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$ |
21,210 |
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$ |
48,700 |
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$ |
118,488 |
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$ |
140,717 |
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Backlog |
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$ |
227,312 |
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$ |
212,311 |
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$ |
227,312 |
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$ |
212,311 |
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Revenue: |
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Product |
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$ |
14,029 |
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$ |
19,389 |
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$ |
79,504 |
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$ |
76,626 |
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Service |
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2,321 |
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1,155 |
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7,803 |
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3,861 |
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Distribution rights |
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119 |
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119 |
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475 |
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475 |
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Total revenue |
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16,469 |
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20,663 |
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87,782 |
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80,962 |
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Cost of revenue: |
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Product |
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17,078 |
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16,958 |
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80,446 |
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66,522 |
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Service |
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3,325 |
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3,105 |
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12,814 |
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7,837 |
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Total cost of revenue |
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20,403 |
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20,063 |
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93,260 |
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74,359 |
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Gross margin |
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(3,934 |
) |
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600 |
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(5,478 |
) |
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6,603 |
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Operating expenses: |
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Research and development |
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6,659 |
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4,014 |
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23,794 |
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16,520 |
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Selling and marketing |
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5,961 |
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5,038 |
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25,806 |
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15,062 |
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General and administrative |
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15,829 |
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13,043 |
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65,717 |
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50,113 |
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Total operating expenses |
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28,449 |
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22,095 |
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115,317 |
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81,695 |
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Loss from operations |
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(32,383 |
) |
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(21,495 |
) |
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(120,795 |
) |
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(75,092 |
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Interest income |
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330 |
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2 |
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1,721 |
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8 |
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Interest expense |
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(1,425 |
) |
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(1,943 |
) |
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(4,327 |
) |
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(7,701 |
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Other income (expense), net |
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(1,731 |
) |
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6,696 |
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3,202 |
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6,389 |
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Loss before provision for income taxes |
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$ |
(35,209 |
) |
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$ |
(16,740 |
) |
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$ |
(120,199 |
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$ |
(76,396 |
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Provision for income taxes |
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— |
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— |
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— |
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— |
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Net loss and comprehensive loss |
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$ |
(35,209 |
) |
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$ |
(16,740 |
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$ |
(120,199 |
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$ |
(76,396 |
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Amortization of beneficial conversion feature related to Series A convertible preferred stock |
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— |
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— |
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— |
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(2,728 |
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Net loss attributable to common stockholders, basic and diluted |
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$ |
(35,209 |
) |
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$ |
(16,740 |
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$ |
(120,199 |
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$ |
(79,124 |
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Net loss per share, basic and diluted |
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$ |
(0.31 |
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$ |
(0.17 |
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$ |
(1.18 |
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$ |
(0.98 |
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Weighted-average common shares used to compute net loss per share attributable to common stockholders, basic and diluted |
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114,585,685 |
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95,822,255 |
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102,001,954 |
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81,123,140 |
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(Unaudited)
(In thousands, except share and per share data)
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December 31, |
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2019 |
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2018 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
226,783 |
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$ |
167,432 |
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Accounts receivable |
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16,817 |
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36,867 |
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Inventory |
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55,031 |
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49,462 |
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Deposits on purchased inventory |
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6,457 |
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8,142 |
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Deferred cost of revenue |
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3,466 |
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9,736 |
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Prepaid expenses and other current assets |
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3,310 |
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6,045 |
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Total current assets |
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311,864 |
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277,684 |
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Property and equipment, net |
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23,399 |
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13,958 |
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Restricted cash |
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1,404 |
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1,933 |
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Intangible assets, net |
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55 |
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— |
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Right-of-use assets |
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11,720 |
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— |
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Other assets |
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1,577 |
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|
1,395 |
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TOTAL ASSETS |
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$ |
350,019 |
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$ |
294,970 |
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
13,739 |
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$ |
10,207 |
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Accrued liabilities |
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21,390 |
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9,983 |
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Customer deposits |
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9,662 |
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19,968 |
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Operating lease liability, current |
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2,264 |
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— |
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Current portion of long-term debt |
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1,556 |
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— |
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Deferred revenue, current portion |
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10,457 |
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13,731 |
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Total current liabilities |
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59,068 |
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53,889 |
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Deferred revenue, net of current portion |
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3,553 |
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5,744 |
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Long-term debt |
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53,995 |
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55,364 |
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Warrant liability |
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5,373 |
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11,844 |
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Operating lease liability, noncurrent |
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10,479 |
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— |
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Other long-term liabilities |
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1,377 |
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|
820 |
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TOTAL LIABILITIES |
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133,845 |
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127,661 |
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Commitments and contingencies (Note 6) |
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Stockholders’ equity: |
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Convertible preferred stock, par value $0.01 per share; 10,000,000 shares authorized at December 31, 2019 and 2018; no shares issued and outstanding at December 31, 2019 and 2018 |
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— |
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— |
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Common stock, par value of $0.01 per share; 300,000,000 shares authorized at December 31, 2019 and 2018; 147,191,695 and 96,332,023 shares issued and outstanding at December 31, 2019 and 2018 |
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1,462 |
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|
952 |
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Additional paid-in capital |
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733,888 |
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|
565,334 |
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Accumulated deficit |
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(519,176 |
) |
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(398,977 |
) |
TOTAL STOCKHOLDERS’ EQUITY |
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|
216,174 |
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|
167,309 |
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TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY |
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$ |
350,019 |
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|
$ |
294,970 |
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Investor Relations:
Michaella Gallina
Vice President, Chief of Staff, Head of Investor Relations and Communications
ViewRay, Inc.
1-844-MRIdian (674-3426)
Email: investors@viewray.com
Media Enquiries:
Karen Hackstaff
Vice President, Strategy and Brand
ViewRay, Inc.
Phone: +1 408-242-2994
Email: media@viewray.com
Q4 2019 Earnings Conference Call March 12, 2020 ©2020 ViewRay, Inc. All rights reserved.
FORWARD-LOOKING STATEMENTS This presentation has been prepared solely for use at this meeting and is intended for investors and analysts only. The material is given in conjunction with an oral presentation and should not be taken out of context. Unless the context requires otherwise, references to “ViewRay,” “the company,” “we,” “us” and “our,” refer to ViewRay, Inc. Except for historical information, ViewRay’s written and accompanying oral presentation may contain forward-looking statements, including statements about the overall industry, including but not limited to: our current expectations of the market; growth drivers; future trends; demand for radiation oncology products and features; and innovation and growth opportunities. Forward-looking statements also include, but are not limited to, statements about ViewRay’s: future orders; backlog or earnings growth; future financial results; and market acceptance of ViewRay’s existing products, future products, or technology. Words such as “could,” “anticipates,” “expects,” “outlook,” “intends,” “plans,” “believes,” “seeks,” “vision,” “estimates,” “may,” “will,” “future,” “horizon,” “aiming,” “driving,” “target” (or variations of them,) and similar statements, are forward-looking statements. These types of statements express management’s beliefs based on the information available to us as of the date of this presentation, are subject to change, and are not guarantees of future performance. Forward-looking statements involve risks, uncertainties, and assumptions that are difficult to predict and could cause ViewRay’s results to differ materially from those presented. These risks, uncertainties, and assumptions include, but are not limited to, changes in: the regulatory environment; global economics; trade compliance requirements, duties or tariffs; third-party reimbursement levels; currency exchange rates; taxation, healthcare law, and product clearance requirements, as well as those related to: adverse publicity about ViewRay and our products; our reliance on sole or limited source suppliers; our ability to commercialize our products successfully; the impact of competitive products and pricing, and all other risks listed from time to time in the company’s filings with the Securities and Exchange Commission, which are incorporated into this Forward-Looking Statements disclosure by this reference. We do not assume any obligation to update or revise the forward-looking statements in ViewRay’s written or oral presentation, whether based on future events, new or additional information or otherwise. ViewRay’s written and oral presentation does not constitute an offer to sell, or the solicitation of an offer to buy, securities. The opinions and clinical experiences presented herein are specific to the featured physicians and/or the featured patients and are for information purposes only. Nothing in this material is intended to provide specific medical advice or to take the place of written law or regulations. Individual customer results are illustrative only and are not predictive of future results. MEDICAL ADVICE DISCLAIMER ViewRay is a medical device manufacturer and cannot and does not recommend specific treatment approaches. Individual results may vary. Forward-Looking Statements & Disclaimer ©2020 ViewRay, Inc. All rights reserved. 2
Our Mission: Treat and Prove What Others Can’t. ©2020 ViewRay, Inc. All rights reserved. patients treated to date1 systems1 Merit demonstrated in of peer-reviewed journal articles and abstracts1 >8,000 34 Hundreds 3
2020 Guidance ©2020 ViewRay, Inc. All rights reserved. Revenue in the range of $58 - $95 million Cash use in the range of $60 to $80 million Full year impact is uncertain 9 installations planned for 2020 in regions with travel restrictions currently in place REVENUE CASH USE CORONAVIRUS 4
Current Technology for SBRT Evidence has shown that ablative dose, 75-100 Gy biological effective doses (BED10), drive favorable outcomes2 Conventional LINACs are limited by dose constraints of surrounding health tissue Clinicians balance the need for ablative doses/tumor coverage vs the risk of toxicity/injury to organs at risk ©2020 ViewRay, Inc. All rights reserved. LOCAL CONTROL TOXICITY Trade-off Between Safety and Effectiveness Limits Adoption of New Treatment Paradigms 5
MRIdian: No Compromise Necessary On-table adaptation provides clinicians: Dose escalation in multiple tumor sites to 75-100 Gy BED103 Maintenance of normal organ dose limits or constraints Tighter treatment margins, PTV ≅ CTV3 Real time tumor tracking & gating: Treat the tumor and spare healthy tissue3 Reduces dose to organs at risk5 by reducing treatment margins Real-time MR Imaging Enables: High-dose, ablative SBRT Reduced toxicity Improved outcomes No fiducials/surrogates required ©2020 ViewRay, Inc. All rights reserved. 6
When ‘Good Enough’ Is Not Good Enough MRIdian vs. Traditional CT Linac Images courtesy of the Siteman Cancer Center at Washington University School of Medicine MRIdian Market-leading CT LINAC 15 – 30mm Treatment Margins 1 – 5mm Treatment Margins Visibly Different Treatment Margins Software differentiates soft tissue from organs and spares healthy tissue ©2020 ViewRay, Inc. All rights reserved. 7
Where We Are Today: MRIdian has been utilized to treat over 50 ICD cancer types, and its evidence has been documented in hundreds of peer-reviewed journal articles and abstracts ©2020 ViewRay, Inc. All rights reserved. Red Journal6 AUMC treated high-risk lung patients, demonstrating the ability to deliver high doses in a complex patient population with low resulting toxicity Red Journal4 Washington University treating APBI in a single fraction, enabled by MRIdian’s small treatment margins MRIdian “provides a convenient, less-toxic, and more feasible option for breast cancer patients post surgery.” Lancet Oncology5 Identified MR-guided therapy as a “practice changing technology that allows for precise delivery of high dose in liver and elsewhere.” 8
BED10 in Gy BED (biologically effective dose) calculations involve the use of an accepted radiobiological equation to compare different fractionations regimens by converting them to comparable values for a given tissue of interest. Grade 3+ Toxicity7 Central Lung SBRT Conventional linac @ >100Gy Up to 33% (up to 8.6% Grade 5) MRIdian linac @ >100Gy Up to 8% Liver SBRT Conventional linac @ >100Gy Up to 21.5% MRIdian linac @ >100Gy Up to 7.7% Pancreas SBRT Conventional linac @ >70Gy Up to 12.3% MRIdian linac @ >70Gy 0% Oligomet SBRT Conventional linac @ >100Gy Up to 29% (Up to 5% Grade 5) MRIdian linac @ >100Gy 0% We Safely Deliver ‘Ablative’ Doses ©2020 ViewRay, Inc. All rights reserved. 9
Some may prescribe very high dose but allow the target coverage to be potentially horribly low. This is how toxicity might be mitigated but on the other hand they are not giving ablative doses to most or all of the tumor in some cases. I am able to treat with ablative doses to all or nearly all of the tumor with MRIdian and still cause almost no major toxicity. ©2020 ViewRay, Inc. All rights reserved. Michael Chuong, M.D. Department of Radiation Oncology Director of Proton Therapy and MR-Guided Radiation Therapy Miami Cancer Institute KOL Perspective “ “ 10
Where We Are Going: Clinical Roadmap clinical collaborators physician-initiated projects in 2020 Multiple tumor sites that prove what others can’t: safely delivering truly ablative doses while reducing toxicity. 26 >30 Plus phase II and III trials in areas such as: Pancreas (our ongoing 13-center study) Central lung Prostate Oligomets Liver Today Tomorrow ©2020 ViewRay, Inc. All rights reserved. 11
Strategic Value Yields Economic Value ©2020 ViewRay, Inc. All rights reserved. UP TO 80 INCREMENTAL PATIENTS FOR CANCER PROGRAMS8 + = Powerful Combination ü “…had no other viable options for treatment.” – Dr. Siddiqui, Henry Ford Health Systems ü Multimodality cancer program with MRIdian enables movement of high fraction patients to fewer fraction SBRT, capturing operational efficiencies to expand program capacity ü Patients with No Other Options Net New Patients Optimizing Care Delivery 12
Optimizing Care Delivery Today ©2020 ViewRay, Inc. All rights reserved. Common IMRT Practice: 28 – 44 Fx × 15 min = 420 – 660 min POTENTIAL TO INCREASE PATIENT THROUGHPUT BY 2.3× TO 3.7× Prostate Cancer MRIdian SBRT: 5 Fx with 2 adaptions = 180 min9 13
Economic Value Development ©2020 ViewRay, Inc. All rights reserved. Flexible Alternative Acquisition Model Reduce Treatment Times Appropriate and Higher Reimbursement $1 million of COGS reduction over the next three years Sub 30-minute treatment times in prostate and breast Continue to work on differentiated reimbursement in the US, Japan, and select European countries ü ü ü 14
Summary ©2020 ViewRay, Inc. All rights reserved. ü ü Roadmap to Win: Further Expanding our Clinical, Strategic, and Economic Value Clinical: 30 physician-initiated projects in 2020, plus developing phase II and III studies Strategic and Economic: Sub 30-minute treatment times, flexible alternative acquisition model, appropriate and higher reimbursement MRIdian offers a no compromise solution to safely deliver ablative doses 15
Q4 Financial Summary Total revenue of $16.5 million in the quarter, primarily from three revenue units, including one system upgrade Received 4 MRIdian orders in the quarter totaling approximately $21.2 million Total backlog as of December 31, 2019: $227.3 million Cash and cash equivalents as of December 31, 2019: $226.8 million ©2020 ViewRay, Inc. All rights reserved. 16
References ©2020 ViewRay, Inc. All rights reserved. 2020 internal and historical company data Hong JC, Ayala-Peacock DN, Lee J, Blackstock AW, Okunieff P, Sung MW, et al. (2018) Classification for long-term survival in oligometastatic patients treated with ablative radiotherapy: A multi-institutional pooled analysis. PLoS ONE 13(4): e0195149; Schneider BJ, Daly ME, Kennedy EB, et al. Stereotactic Body Radiotherapy for Early-Stage Non-Small-Cell Lung Cancer: American Society of Clinical Oncology Endorsement of the American Society for Radiation Oncology Evidence-Based Guideline. J Clin Oncol. 2018;36(7):710–719; Finazzi T, Haasbeek CJA, Spoelstra FOB, Palacios MA, Admiraal MA, Bruynzeel AME, Slotman BJ, Lagerwaard FJ, Senan S, Clinical outcomes of stereotactic MR-guided adaptive radiation therapy for high-risk lung tumors International Journal of Radiation Oncology • Biology• Physics (2020); Toesca DA, Osmundson EC, Eyben RV, et al. Central liver toxicity after SBRT: An expanded analysis and predictive nomogram. Radiother Oncol. 2017;122(1):130–136; Rosenberg S. A. et al. (2018). A multi-institutional experience of MR-guided liver stereotactic body radiation therapy. Advances in Radiation Oncology, 4(1), 142-149; Herman JM, Chang DT, Goodman KA, et al. Phase 2 multi-institutional trial evaluating gemcitabine and stereotactic body radiotherapy for patients with locally advanced unresectable pancreatic adenocarcinoma. Cancer. 2015;121(7):1128-1137. ; Rudra S. et al. (2019). Using adaptive magnetic resonance image-guided radiation therapy for treatment of inoperable pancreatic cancer. Cancer Medicine, 8(5), 2123-2132; Palma DA, Olson R, Harrow S, et al. Stereotactic ablative radiotherapy versus standard of care palliative treatment in patients with oligometastatic cancers (SABR-COMET): a randomised, phase 2, open-label trial. Lancet. 2019;393(10185):2051–2058. doi:10.1016/S0140-6736(18)32487-5; Henke, L., et al. (2018). Phase I trial of stereotactic MR-guided online adaptive radiation therapy (SMART) for the treatment of oligometastatic or unresectable primary malignancies of the abdomen. Radiotherapy and Oncology, 126(3),Henke, L., et al. (2018). Phase I trial of stereotactic MR-guided online adaptive radiation therapy (SMART) for the treatment of oligometastatic or unresectable primary malignancies of the abdomen. Radiotherapy and Oncology, 126(3), 519-526; Henke LE, et al. Stereotactic mr-guided online adaptive radiation therapy (smart) for ultracentral thorax malignancies: Results of a phase 1 trial. Adv Radiat Oncol 2019;4:201-209; Rosenberg SA, et al. A multi-institutional experience of mr-guided liver stereotactic body radiation therapy. Adv Radiat Oncol 2019;4:142-149; Finazzi T, Haasbeek CJA, Spoelstra FOB, Palacios MA, Admiraal MA, Bruynzeel AME, Slotman BJ, Lagerwaard FJ, Senan S, Clinical outcomes of stereotactic MR-guided adaptive radiation therapy for high-risk lung tumors International Journal of Radiation Oncology • Biology• Physics (2020); Rudra S. et al. (2019). Using adaptive magnetic resonance image-guided radiation therapy for treatment of inoperable pancreatic cancer. Cancer Medicine, 8(5), 2123-2132; Finazzi, et al. Role of on-table plan adaptation in MR-guided ablative radiation therapy for central lung tumors. Int J Radiat Oncol Biol Phys. 2019 Jul 15;104(4):933-941. doi: 10.1016/j.ijrobp.2019.03.035. Epub 2019 Mar 28; Kennedy WR, Thomas MA, Stanley JA, Luo J, Ochoa LL, Clifton KK, Cyr AE, Margenthaler JA, DeWees TA, Price A, Kashani R, Green O, Zoberi I, Single Institution Phase I/II Prospective Clinical Trial of Single Fraction High Gradient Adjuvant Partial Breast Irradiation for Hormone Sensitive Stage 0-I Breast Cancer, International Journal of Radiation Oncology • Biology • Physics (2020); Henke, L., et al. (2018). Phase I trial of stereotactic MR-guided online adaptive radiation therapy (SMART) for the treatment of oligometastatic or unresectable primary malignancies of the abdomen. Radiotherapy and Oncology, 126(3), 519-526; Bruynzeel AME, Tetar SU, Oei SS, Senan S, Haasbeek CJA, Spoelstra FOB, Piet AHM, Meijnen P, Bakker van der Jagt MAB, Fraikin T, Slotman BJ, van Moorselaar RJA, Lagerwaard FJ, A prospective single-arm phase II study of stereotactic magnetic-resonance-guided adaptive radiotherapy for prostate cancer: Early toxicity results, International Journal of Radiation Oncology • Biology • Physics (2019); Finazzi T, Haasbeek CJA, Spoelstra FOB, Palacios MA, Admiraal MA, Bruynzeel AME, Slotman BJ, Lagerwaard FJ, Senan S, Clinical outcomes of stereotactic MR-guided adaptive radiation therapy for high-risk lung tumors International Journal of Radiation Oncology • Biology • Physics (2020); El-Bared N, et al. Dosimetric benefits and practical pitfalls of daily online adaptive mri-guided stereotactic radiotherapy for pancreatic cancer. Pract Radiat Oncol 2018; Hegde JV, et al. Magnetic resonance imaging guidance mitigates the effects of intrafraction prostate motion during stereotactic body radiotherapy for prostate cancer. Cureus 2018;10:e2442; Kishan AU, et al. Mri-guided dose-escalated salvage radiotherapy for bulky bladder neck recurrence of prostate cancer. Cureus 2018;10:e2360. Henke, L., et al. (2018). Phase I trial of stereotactic MR-guided online adaptive radiation therapy (SMART) for the treatment of oligometastatic or unresectable primary malignancies of the abdomen. Radiotherapy and Oncology, 126(3), 519-526; Henke LE, et al. Stereotactic mr-guided online adaptive radiation therapy (smart) for ultracentral thorax malignancies: Results of a phase 1 trial. Adv Radiat Oncol 2019;4:201-209; Rosenberg SA, et al. A multi-institutional experience of mr-guided liver stereotactic body radiation therapy. Adv Radiat Oncol 2019;4:142-149; Finazzi T, Haasbeek CJA, Spoelstra FOB, Palacios MA, Admiraal MA, Bruynzeel AME, Slotman BJ, Lagerwaard FJ, Senan S, Clinical outcomes of stereotactic MR-guided adaptive radiation therapy for high-risk lung tumors International Journal of Radiation Oncology • Biology• Physics (2020); Rudra S. et al. (2019). Using adaptive magnetic resonance image-guided radiation therapy for treatment of inoperable pancreatic cancer. Cancer Medicine, 8(5), 2123-2132; Finazzi, et al. Role of on-table plan adaptation in MR-guided ablative radiation therapy for central lung tumors. Int J Radiat Oncol Biol Phys. 2019 Jul 15;104(4):933-941. doi: 10.1016/j.ijrobp.2019.03.035. Epub 2019 Mar 28; Kennedy WR, Thomas MA, Stanley JA, Luo J, Ochoa LL, Clifton KK, Cyr AE, Margenthaler JA, DeWees TA, Price A, Kashani R, Green O, Zoberi I, Single Institution Phase I/II Prospective Clinical Trial of Single Fraction High Gradient Adjuvant Partial Breast Irradiation for Hormone Sensitive Stage 0-I Breast Cancer, International Journal of Radiation Oncology • Biology • Physics (2020); Henke, L., et al. (2018). Phase I trial of stereotactic MR-guided online adaptive radiation therapy (SMART) for the treatment of oligometastatic or unresectable primary malignancies of the abdomen. Radiotherapy and Oncology, 126(3), 519-526; Bruynzeel AME, Tetar SU, Oei SS, Senan S, Haasbeek CJA, Spoelstra FOB, Piet AHM, Meijnen P, Bakker van der Jagt MAB, Fraikin T, Slotman BJ, van Moorselaar RJA, Lagerwaard FJ, A prospective single-arm phase II study of stereotactic magnetic-resonance-guided adaptive radiotherapy for prostate cancer: Early toxicity results, International Journal of Radiation Oncology • Biology • Physics (2019); Finazzi T, Haasbeek CJA, Spoelstra FOB, Palacios MA, Admiraal MA, Bruynzeel AME, Slotman BJ, Lagerwaard FJ, Senan S, Clinical outcomes of stereotactic MR-guided adaptive radiation therapy for high-risk lung tumors International Journal of Radiation Oncology • Biology • Physics (2020); El-Bared N, et al. Dosimetric benefits and practical pitfalls of daily online adaptive mri-guided stereotactic radiotherapy for pancreatic cancer. Pract Radiat Oncol 2018; Hegde JV, et al. Magnetic resonance imaging guidance mitigates the effects of intrafraction prostate motion during stereotactic body radiotherapy for prostate cancer. Cureus 2018;10:e2442; Kishan AU, et al. Mri-guided dose-escalated salvage radiotherapy for bulky bladder neck recurrence of prostate cancer. Cureus 2018;10:e2360. Kennedy WR, Thomas MA, Stanley JA, Luo J, Ochoa LL, Clifton KK, Cyr AE, Margenthaler JA, DeWees TA, Price A, Kashani R, Green O, Zoberi I, Single Institution Phase I/II Prospective Clinical Trial of Single Fraction High Gradient Adjuvant Partial Breast Irradiation for Hormone Sensitive Stage 0-I Breast Cancer, International Journal of Radiation Oncology • Biology • Physics (2020) Witt, J., et al. (2020). MRI-guided adaptive radiotherapy for liver tumours: visualizing the future. Lancet Oncol 2020; 21:e74-82. Finazzi T, Haasbeek CJA, Spoelstra FOB, Palacios MA, Admiraal MA, Bruynzeel AME, Slotman BJ, Lagerwaard FJ, Senan S, Clinical outcomes of stereotactic MR-guided adaptive radiation therapy for high-risk lung tumors International Journal of Radiation Oncology • Biology • Physics (2020) Schneider BJ, Daly ME, Kennedy EB, et al. Stereotactic Body Radiotherapy for Early-Stage Non-Small-Cell Lung Cancer: American Society of Clinical Oncology Endorsement of the American Society for Radiation Oncology Evidence-Based Guideline. J Clin Oncol. 2018;36(7):710–719; Finazzi T, Haasbeek CJA, Spoelstra FOB, Palacios MA, Admiraal MA, Bruynzeel AME, Slotman BJ, Lagerwaard FJ, Senan S, Clinical outcomes of stereotactic MR-guided adaptive radiation therapy for high-risk lung tumors International Journal of Radiation Oncology • Biology• Physics (2020); Toesca DA, Osmundson EC, Eyben RV, et al. Central liver toxicity after SBRT: An expanded analysis and predictive nomogram. Radiother Oncol. 2017;122(1):130–136; Rosenberg S. A. et al. (2018). A multi-institutional experience of MR-guided liver stereotactic body radiation therapy. Advances in Radiation Oncology, 4(1), 142-149; Herman JM, Chang DT, Goodman KA, et al. Phase 2 multi-institutional trial evaluating gemcitabine and stereotactic body radiotherapy for patients with locally advanced unresectable pancreatic adenocarcinoma. Cancer. 2015;121(7):1128-1137; Rudra S. et al. (2019). Using adaptive magnetic resonance image-guided radiation therapy for treatment of inoperable pancreatic cancer. Cancer Medicine, 8(5), 2123-2132; Palma DA, Olson R, Harrow S, et al. Stereotactic ablative radiotherapy versus standard of care palliative treatment in patients with oligometastatic cancers (SABR-COMET): a randomised, phase 2, open-label trial. Lancet. 2019;393(10185):2051–2058. doi:10.1016/S0140-6736(18)32487-5; Henke, L., et al. (2018). Phase I trial of stereotactic MR-guided online adaptive radiation therapy (SMART) for the treatment of oligometastatic or unresectable primary malignancies of the abdomen. Radiotherapy and Oncology, 126(3), 519-526. Based on 2020 customer survey data Internal company data; Clinical implementation of magnetic resonance imaging guided adaptive radiotherapy for localized prostate cancer Tetar, Shyama U. et al. Physics and Imaging in Radiation Oncology, Volume 9, 69 – 76.