UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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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):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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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 August 5, 2021, ViewRay, Inc. (“ViewRay” or the “Company”) issued a press release announcing its financial results for the quarter ended June 30, 2021. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
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 August 5, 2021. 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 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 and 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, 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.
Exhibit Number |
Description |
99.1 |
Press Release dated August 5, 2021 announcing financial results for the quarter ended June 30, 2021. |
99.2 |
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104 |
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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 thereunto duly authorized.
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VIEWRAY, INC. |
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Date: August 5, 2021 |
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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 Second Quarter 2021 Results
CLEVELAND, August 5, 2021 — ViewRay, Inc. (Nasdaq: VRAY) (the "Company") today announced financial results for the second quarter ended June 30, 2021.
Second Quarter 2021 Highlights
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Received seven new orders for MRIdian systems totaling $37.9 million, compared to four new orders totaling $24.6 million in the second quarter of 2020. |
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Total backlog increased to $278.4 million as of June 30, 2021, compared to $232.2 million as of June 30, 2020. |
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Total revenue of $15.0 million primarily from two revenue units, compared to $14.2 million primarily from two revenue units in the second quarter of 2020. |
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Cash usage in the second quarter of 2021 was approximately $15 million compared to approximately $11 million in the second quarter of 2020. |
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Cash and cash equivalents were $166.9 million as of June 30, 2021. |
“Our second quarter performance is a solid step forward and reflects progress on our commercial, innovation, and clinical pipelines. Our team has executed very well in an environment that continues to be challenging.” said Scott Drake, President and CEO. “We are well positioned to drive further growth, therapy adoption, and extend our innovation lead.”
Three Months Ended June 30, 2021 Financial Results
Total revenue for the three months ended June 30, 2021 was $15.0 million compared to $14.2 million for the same period last year.
Total gross profit (loss) for the three months ended June 30, 2021 was ($1.7) million, compared to ($1.0) million for the same period last year.
Total operating expenses for the three months ended June 30, 2021 were $24.8 million, compared to $24.5 million for the same period last year.
Net loss for the three months ended June 30, 2021 was $31.0 million, or $0.19 per share, compared to $26.2 million, or $0.18 per share, for the same period last year.
ViewRay had total cash and cash equivalents of $166.9 million at June 30, 2021.
Six Months Ended June 30, 2020 Financial Results:
Total revenue for the six months ended June 30, 2021 was $30.6 million compared to $28.5 million for the same period last year.
Total gross profit (loss) for the six months ended June 30, 2021 was $(1.4) million, compared to $(3.1) million for the same period last year.
Total operating expenses for the six months ended June 30, 2021 were $49.8 million, compared to $52.5 million for the same period last year.
Net loss for the six months ended June 30, 2021 was $57.7 million, or $0.36 per share, compared to $53.7 million, or $0.36 per share, for the same period last year.
Financial Guidance
For the full year 2021, ViewRay anticipates total revenue to be in the range of $63 million to $73 million, and total cash usage to be in the range of $58 million to $68 million.
Conference Call and Webcast
ViewRay will hold a conference call to discuss results on Thursday, August 5, 2021 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 confirmation number is 8473598. A live webcast of the conference call will be available on the investor relations page of ViewRay's corporate website at http://investors.viewray.com/events-and-presentations/upcoming-events.
After the live webcast, a replay will remain available online on the investor relations page of ViewRay's website, under "Financial Events and Webinars", for 14 days following the call. In addition, a telephonic replay of the call will be available for seven days after the call. 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 8473598.
About ViewRay®
ViewRay, Inc. (Nasdaq: VRAY), designs, manufactures, and markets the MRIdian® MR-Guided 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, anticipated future orders, ViewRay's financial guidance for the full year 2021, anticipated future operating and financial performance, treatment results, therapy adoption, innovation and the performance of the MRIdian systems. 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, the timing of delivery of ViewRay's products, the timing, length, and severity of the recent COVID-19 (coronavirus) pandemic, including its impacts across our businesses on demand, operations and our global supply chains, the 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, 2020 and its 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.
VIEWRAY, INC.
Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
(In thousands, except share and per share data)
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For the Three Months Ended June 30, |
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For the Six Months Ended June 30, |
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2021 |
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2020 |
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2021 |
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2020 |
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Revenue: |
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Product |
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$ |
10,917 |
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$ |
10,615 |
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$ |
22,296 |
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$ |
22,085 |
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Service |
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3,994 |
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3,490 |
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8,021 |
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6,151 |
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Distribution rights |
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119 |
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119 |
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238 |
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238 |
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Total revenue |
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15,030 |
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14,224 |
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30,555 |
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28,474 |
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Cost of revenue: |
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Product |
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12,180 |
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12,714 |
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22,865 |
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25,843 |
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Service |
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4,522 |
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2,552 |
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9,040 |
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5,780 |
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Total cost of revenue |
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16,702 |
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15,266 |
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31,905 |
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31,623 |
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Gross profit (loss) |
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(1,672 |
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(1,042 |
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(1,350 |
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(3,149 |
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Operating expenses: |
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Research and development |
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7,903 |
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6,211 |
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14,413 |
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12,548 |
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Selling and marketing |
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3,052 |
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3,093 |
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5,900 |
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8,916 |
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General and administrative |
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13,858 |
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15,227 |
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29,497 |
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31,015 |
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Total operating expenses |
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24,813 |
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24,531 |
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49,810 |
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52,479 |
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Loss from operations |
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(26,485 |
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(25,573 |
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(51,160 |
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(55,628 |
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Interest income |
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3 |
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87 |
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5 |
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782 |
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Interest expense |
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(1,060 |
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(1,071 |
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(2,118 |
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(2,109 |
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Other income (expense), net |
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(3,434 |
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405 |
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(4,446 |
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3,271 |
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Loss before provision for income taxes |
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$ |
(30,976 |
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$ |
(26,152 |
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$ |
(57,719 |
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$ |
(53,684 |
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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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$ |
(30,976 |
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$ |
(26,152 |
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$ |
(57,719 |
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$ |
(53,684 |
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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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— |
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Net loss attributable to common stockholders, basic and diluted |
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$ |
(30,976 |
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$ |
(26,152 |
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$ |
(57,719 |
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$ |
(53,684 |
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Net loss per share, basic and diluted |
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$ |
(0.19 |
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$ |
(0.18 |
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$ |
(0.36 |
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$ |
(0.36 |
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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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162,283,348 |
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147,563,278 |
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161,217,083 |
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147,506,244 |
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Gross Orders |
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$ |
37,900 |
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$ |
24,600 |
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$ |
78,750 |
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$ |
47,200 |
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Backlog |
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$ |
278,434 |
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$ |
232,273 |
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$ |
278,434 |
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$ |
232,273 |
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VIEWRAY, INC.
(Unaudited)
(In thousands, except share and per share data)
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June 30, 2021 |
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December 31, 2020 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
166,925 |
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$ |
156,720 |
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Accounts receivable |
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15,416 |
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11,769 |
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Inventory, net of allowance of $2,181 and $2,286, respectively |
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41,878 |
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46,641 |
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Deposits on purchased inventory |
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3,679 |
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2,084 |
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Deferred cost of revenue |
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1,199 |
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1,954 |
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Prepaid expenses and other current assets |
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5,101 |
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5,257 |
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Total current assets |
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234,198 |
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224,425 |
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Property and equipment, net |
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21,754 |
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24,062 |
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Restricted cash |
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1,460 |
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1,460 |
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Intangible assets, net |
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47 |
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50 |
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Right-of-use assets |
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9,018 |
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10,129 |
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Other assets |
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7,392 |
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1,426 |
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TOTAL ASSETS |
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$ |
273,869 |
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$ |
261,552 |
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
7,525 |
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$ |
9,984 |
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Accrued liabilities |
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18,304 |
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19,281 |
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Customer deposits |
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14,183 |
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15,463 |
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Operating lease liability, current |
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1,938 |
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2,089 |
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Deferred revenue, current |
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11,041 |
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10,094 |
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Total current liabilities |
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52,991 |
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56,911 |
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Deferred revenue, net of current portion |
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4,962 |
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2,572 |
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Long-term debt |
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57,101 |
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56,940 |
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Warrant liabilities |
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9,212 |
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4,864 |
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Operating lease liability, noncurrent |
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8,039 |
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9,043 |
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Other long-term liabilities |
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2,513 |
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|
956 |
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TOTAL LIABILITIES |
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134,818 |
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131,286 |
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Commitments and contingencies (Note 6) |
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Stockholders’ equity: |
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Preferred stock, par value of $0.01 per share; 10,000,000 shares authorized at June 30, 2021 and December 31, 2020; no shares issued and outstanding at June 30, 2021 and December 31, 2020 |
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— |
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— |
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Common stock, par value of $0.01 per share; 300,000,000 shares authorized at June 30, 2021 and December 31, 2020; 163,590,744 and 148,615,351 shares issued and outstanding at June 30, 2021 and December 31, 2020 |
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1,624 |
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1,476 |
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Additional paid-in capital |
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822,230 |
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755,874 |
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Accumulated deficit |
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(684,803 |
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(627,084 |
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TOTAL STOCKHOLDERS’ EQUITY |
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139,051 |
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130,266 |
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TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY |
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$ |
273,869 |
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$ |
261,552 |
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Contact:
Investor Relations:
Ashley Kluth
Investor Relations
ViewRay, Inc.
1-844-MRIdian (674-3426)
Email: investors@viewray.com
Media Enquiries:
Samantha Pfeil
Marketing Communications
ViewRay, Inc.
Email: media@viewray.com
Earnings Call – Q2 2021 August 5, 2021 Exhibit 99.2
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 financial guidance; current expectations of the market; growth drivers; future trends; demand for radiation oncology products and features; treatment results; 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: the effect of COVID-19 on our business operations and financial condition; 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. ViewRay issued a press release and presentation for today’s call. The presentation can be viewed live on the webcast or downloaded from the “financial events and webinars” portion of our website at www.investors.viewray.com. The call is being broadcast and webcast live, and a replay will be available for 14 days. Listeners are cautioned that comments made by management during this call may include forward-looking statements within the meaning of federal securities laws. These statements involve material risks and uncertainties, and actual results could differ from those projected in any forward-looking statement due to numerous factors. For a description of these risks and uncertainties, please see ViewRay's Annual Report on Form 10-K for the fiscal year ended December 31, 2020, and its Quarterly Reports on Form 10-Q, as updated periodically with the company's other SEC filings. Furthermore, the content of this conference call contains time-sensitive information accurate only as of today, May 6, 2021. ViewRay undertakes no obligation to revise or otherwise update any statements to reflect events or circumstances after the date of this call. 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
Our mission: Treat and prove what others can’t. ©2021 ViewRay, Inc. All rights reserved.
What We Achieved Q2 2021 financial results 2Q 2020 2Q 2021 ©2021 ViewRay, Inc. All rights reserved.
Customers’ Definition of Clinical Success MRIdian SMART: Stereotactic MR-guided Adaptive Radiotherapy Among alternatives in the clinical landscape, we have found only MRIdian’s evidence fits this criteria.1 Ablative Dose Tight Margins No Fiducials No or Low Grade 3 Toxicity The MRIdian 5 1 2 3 5 5 or Fewer Fractions 4 ©2021 ViewRay, Inc. All rights reserved.
©2021 ViewRay, Inc. All rights reserved. + This presentation is intended for investors and analysts only. Some features described herein are not and may never be cleared or approved for sale in any markets. Recent Highlights Innovation and clinical pipelines accrue customer traction
Prospective studies. Larger ‘N’ Confirm signals in key tumor sites Safety and Efficacy endpoints Randomized controlled trials Comparative Safety and efficacy endpoints 60+ investigator-initiated trials Feasibility Explore new indications/expand SMART Reduce fx and improve workflow MIRAGE (CT vs. MRIdian prostate) PANCOSAR (SMART in medically inoperable pancreas) SMART Pancreas SHORTER (20 vs 5 fx post-op prostate) SCIMITAR (post-op SMART) Immunotherapy + SMART Lung STAAR (central/ultra central SMART) Pre-op Gastric SMILE (prostate SBRT German multi-cent) MARTHA (head and neck) MASPAC (late-stage pancreas multi-cent) Compassionate Access Program (pancreas) Radiomics Synthetic CT Workflow efficiency Prone Breast APBI Oligomets AI dose calculation DWI SMART ONE Sarcoma Lymphoma Cervical Rectal Liver mets SMART Master CONFIRM Phase 3 (Definitive) 3 Phase 2 (Confirmatory) 2 Phase 1 (Exploratory)1 MRIdian Clinical Pipeline Constant flow of proof to drive adoption ©2021 ViewRay, Inc. All rights reserved.
Prospective studies. Larger ‘N’ Confirm signals in key tumor sites Safety and Efficacy endpoints Randomized controlled trials Comparative Safety and efficacy endpoints 60+ investigator-initiated trials Feasibility Explore new indications/expand SMART Reduce fx and improve workflow MIRAGE (CT vs. MRIdian prostate) PANCOSAR (SMART in medically inoperable pancreas) SMART Pancreas SHORTER (20 vs 5 fx post-op prostate) SCIMITAR (post-op SMART) Immunotherapy + SMART STAAR Lung (central/ultra central SMART) Pre-op Gastric SMILE (prostate SBRT German multi-cent) MARTHA (head and neck) MASPAC (late-stage pancreas multi-cent) Compassionate Access Program (pancreas) Radiomics Synthetic CT Workflow efficiency Prone Breast APBI Oligomets AI dose calculation DWI SMART ONE Sarcoma Lymphoma Cervical Rectal Liver mets SMART Master CONFIRM Phase 3 (Definitive) Phase 2 (Confirmatory) 2 Phase 1 (Exploratory) 1 Lung STAAR central/ultra central SMART Dr. Rupesh Kotecha, MCI Prospective trial Safely treat with little to no toxicity Preliminary data published SMART ONE Dr. Michael Chuong, MCI Patient enrollment started Single fraction ablative dose to multiple tumors in single patient MRIdian Clinical Pipeline Constant flow of proof to drive adoption ©2021 ViewRay, Inc. All rights reserved.
©2021 ViewRay, Inc. All rights reserved. Proving Economic and Strategic Value Executive Customer Roundtable1 ” “Game-changer” “Mind-blowing” “Exceeded all expectations” “Truly transformative” “Patients came here because of the machine itself. ” Individual customer results are illustrative only and are not predictive of future results.
©2021 ViewRay, Inc. All rights reserved. Proving Economic and Strategic Value Executive Customer Roundtable1 Dana-Farber Brigham & Women’s Miami Cancer Institute 24% of patients from outside catchment area Almost doubled expected ROI in just 3 years “MRIdian is APM friendly” Technological differentiator 25% Net new patients vs 13% expected Demand for machine has outpaced availability 98% SBRT vs 50% Expected Individual customer results are illustrative only and are not predictive of future results.
More patients. More proof. More promise. ©2021 ViewRay, Inc. All rights reserved. = Therapy Adoption + Program development Innovation Commercial Sub 20-minute treatment times Workflow Automation Enhanced MRI imaging Increased dosing Brain treatment package Remote access Cost reduction Incremental Investment Driving Program Success Define customer success Deliver customer success Build successful MRIdian programs Drive improved commercial performance and value creation One successful MRIdian program leads to another This presentation is intended for investors and analysts only. Some features described herein are not and may never be cleared or approved for sale in any markets.
Financial Results Q2 2021
ASP of $6.1M excluding upgrades Backlog increased 20% YoY Strong customer engagement despite the challenges posed by the ongoing pandemic Operating Expenses effectively flat YoY R&D up 27% S&M flat G&A down 9% Revenue increased 6% U.S. revenue: $12.4 million Outside of U.S. revenue: $2.6 million Financial Highlights ©2021 ViewRay, Inc. All rights reserved.
©2021 ViewRay, Inc. All rights reserved. FY 2020 FY 2021 GROWTH % Guidance (1) Excludes the January 2021 equity financing
Presentation Citations Slide 3 Internal and historical company data 06/30/2021 MRIdian log data Slide 5 Ablative dose, Tight margins, No fiducials: Chuong MD, Bryant J, Mittauer KE, Hall M, Kotecha R, Alvarez D, Romaguera T, Rubens M, Adamson S, Godley A, Mishra V, Luciani G, Gutierrez AN, Ablative 5-fraction stereotactic magnetic resonance-guided radiation therapy (MRgRT) with on-table adaptive replanning and elective nodal irradiation for inoperable pancreas cancer, Practical Radiation Oncology (2020) Five or fewer factions, No or low grade 3 toxicity: 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); 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; 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; 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; 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); 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) Slide 6 SMART ONE: Miami Cancer Institute, PI: Dr. Michael Chuong, “Stereotactic MRI-Guided Adaptive Radiation Therapy Delivered in One Fraction for Inoperable Primary or Metastatic Carcinoma (SMART One)” LUNG STAAR: LUNG STAAR: Miami Cancer Institute, PI: Dr. Rupesh Kotecha, “Phase II Study of Stereotactic MR Guided Adaptive Radiotherapy for Central and Ultra-central Lung Tumors”
Presentation Citations Slide 7 1. Phase 1 (Exploratory) - SMART ONE: Miami Cancer Institute, PI: Dr. Michael Chuong, “Stereotactic MRI-Guided Adaptive Radiation Therapy Delivered in One Fraction for Inoperable Primary or Metastatic Carcinoma (SMART One)” - SMART Master: https://clinicaltrials.gov/ct2/show/NCT04115254 - CONFIRM: https://clinicaltrials.gov/ct2/show/NCT04368702 2. Phase 2 (Confirmatory) - SMART Pancreas: https://clinicaltrials.gov/ct2/show/NCT03621644 - SHORTER: https://clinicaltrials.gov/ct2/show/NCT04422132 - SCIMITAR: https://clinicaltrials.gov/ct2/show/NCT03541850 - Immunotherapy + SMART: https://clinicaltrials.gov/ct2/show/NCT04376502 - LUNG STAAR: LUNG STAAR: Miami Cancer Institute, PI: Dr. Rupesh Kotecha, “Phase II Study of Stereotactic MR Guided Adaptive Radiotherapy for Central and Ultra-central Lung Tumors” - Pre-op Gastric: https://clinicaltrials.gov/ct2/show/NCT04162665 - SMILE: Heidelberg University, PI: Dr. Stefan Korber, “Stereotactic MRI-guided radiation therapy for Localized prostate cancer (SMILE)” - MARTHA: https://clinicaltrials.gov/ct2/show/NCT03972072 - MASPAC: University of Zurich, PI: Dr. Matea Pavic, “MR-guided Adaptive Stereotactic Body Radiotherapy (SBRT) of primary tumor for pain control in metastatic Pancreatic ductal adenocarcinoma (mPDAC) – a multicenter randomized, controlled, open-label, phase IIb trial (MASPAC Study)” - Compassionate Access Program: https://www.genesiscare.com/uk/compassionate-access-programme/ 3. Phase 3 (Definitive) - MIRAGE: https://clinicaltrials.gov/ct2/show/NCT04384770 - PANCOSAR: https://www.oncologie.nu/nieuws/stereotactische-radiotherapie-voor-kwetsbare-pati%C3%ABnten-met-lokaal-pancreascarcinoom/ Slide 8 SMART ONE: Miami Cancer Institute, PI: Dr. Michael Chuong, “Stereotactic MRI-Guided Adaptive Radiation Therapy Delivered in One Fraction for Inoperable Primary or Metastatic Carcinoma (SMART One)” LUNG STAAR: LUNG STAAR: Miami Cancer Institute, PI: Dr. Rupesh Kotecha, “Phase II Study of Stereotactic MR Guided Adaptive Radiotherapy for Central and Ultra-central Lung Tumors” Slide 9 Executive customer round table: https://viewray.com/webinars/ Slide 10 Executive customer round table: https://viewray.com/webinars/
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