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): January 13, 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.)

 

 

 

2 Thermo Fisher Way

Oakwood Village, Ohio

 

44146

(Address of Principal Executive Offices)

 

(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

 

Trading

Symbol(s)

 

Name of each exchange on which registered

Common Stock, par value $0.01

 

VRAY

 

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 January 13, 2020, ViewRay, Inc. (“ViewRay” or the “Company”) issued a press release announcing preliminary results for the fourth quarter and full 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 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

 

On January 13, 2020, the Company announced that James (“Jim”) Alecxih will resign as the Company’s Chief Commercial Officer, effective as of January 17, 2020. Mr. Alecxih’s departure from the Company is not the result of any issue, concern or disagreement regarding the Company’s operations, policies or practices of the Company. At this time the Company does not intend to backfill the Chief Commercial Officer role.

 

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 January 13, 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 “Disclaimer” in Exhibit 99.2 attached hereto.

 

The information in this Item 7.01 of this 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

Press Release dated January 13, 2020.

99.2

ViewRay Investor Presentation.

 

 


 

 

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.

 

 

 

VIEWRAY, INC.

 

 

 

 

Date: January 13, 2020

 

By:

/s/ Robert S. McCormack

 

 

 

Robert S. McCormack

 

 

 

Senior Vice President, General

Counsel and Corporate Secretary

 

 

 

Exhibit 99.1

 

ViewRay Announces Preliminary Fourth Quarter and Full Year 2019 Results

 

CLEVELAND, Ohio, January 13, 2020—ViewRay, Inc. (NASDAQ: VRAY) today announced preliminary results for the fourth quarter and full fiscal year ended December 31, 2019. The preliminary results have not been audited and are subject to change.

 

Selected Fourth Quarter and Full Year 2019 Preliminary Results:

 

 

Total revenue of approximately $17 million in the fourth quarter of 2019, primarily from three revenue units including one system upgrade, compared to total revenue of $21 million, primarily from four revenue units including one system upgrade, in the fourth quarter of 2018.

 

 

Received four new orders for MRIdian systems totaling approximately $21 million in the fourth quarter of 2019, compared to eight new orders totaling approximately $49 million in the fourth quarter of 2018.

 

 

Full year 2019 revenue of approximately $88 million, primarily from 15 revenue units, including two system upgrades, compared to 2018 revenue of approximately $81 million, primarily from 15 revenue units, including two system upgrades.

 

 

Total backlog was approximately $227 million as of December 31, 2019.

 

 

Cash and cash equivalents were approximately $227 million as of December 31, 2019. Cash burn in the fourth quarter of 2019, excluding the impact of the December 2019 financing, was approximately $3 million.

 

 

Chief Commercial Officer Jim Alecxih will be leaving the company effective January 17, 2020. At this time the company does not intend to backfill the Chief Commercial Officer role.

 

“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. “We are now better positioned than ever to improve the treatment paradigm for cancer patients. Today we also announced that Jim Alecxih, our Chief Commercial Officer, will be leaving the company to pursue other opportunities. We thank Jim for his service."

 

Financial guidance for 2020 will be provided on the company’s fourth quarter earnings conference call later this year.

 

About ViewRay

 

ViewRay®, Inc. (Nasdaq: VRAY), designs, manufactures, and markets the MRIdian® radiation therapy system. MRIdian is built upon a proprietary high-definition MR imaging system designed from the ground up to address the unique challenges and clinical workflow for advanced radiation oncology. Unlike MR systems used in diagnostic radiology, MRIdian's high-definition MR was purposely built to deliver high-precision radiation without unnecessary beam distortion, and consequently, help to mitigate skin toxicity and other safety concerns that may otherwise arise when high magnetic fields interact with radiation beams.

 



 

 

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 2019 and ViewRay's conference call to discuss its fourth quarter 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, 2018 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.

 

Contact

 

Investor Relations:

Michaella Gallina

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

 

SLIDE 1

January 2020 Exhibit 99.2

SLIDE 2

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. MEDICAL ADVICE DISCLAIMER ViewRay is a medical device manufacturer and cannot and does not recommend specific treatment approaches. Individual results may vary. ADDITIONAL INFORMATION We have filed with the Securities and Exchange Commission (SEC) a registration statement on Form S-3 (including a prospectus) and will file with the SEC a prospectus supplement to the prospectus for the offering to which this presentation relates.  Before you invest, you should read the prospectus supplement and accompanying prospectus in that registration statement and the documents incorporated by reference or filed as exhibits to the registrations statement for more complete information about ViewRay and this offering.  You may obtain these documents and other documents for free by visiting EDGAR on the SEC website. Alternatively, copies of the preliminary prospectus supplement and accompanying prospectus, when available, may be obtained from Piper Jaffray & Co. by telephone at (800) 747-3924 or by e-mail at prospectus@pjc.com. This presentation shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction. FORWARD-LOOKING STATEMENTS & DISCLAIMER

SLIDE 3

Clearly Differentiated Technology Moving to personalized care RADIATION ONCOLOGY SURGERY MEDICAL ONCOLOGY

SLIDE 4

MRIDIAN XRAY CONE BEAM CT The Evolution of Radiation Therapy

SLIDE 5

MRIdian Market-leading CT LINAC Images courtesy of Amsterdam UMC Clearly Differentiated Technology When a millimeter is a mile

SLIDE 6

Proven next-generation radiation therapy Differentiated: safely delivers high-dose, adaptive, beam-gated SBRT Significant reduction in toxicities across a variety of tumor sites1,2,3,4,5,6 Surpassing 6,500* patients 100s of peer-reviewed journal articles and abstracts proving clinical utility MRIdian MRI-Guided Radiotherapy * As of November 2019

SLIDE 7

MRIdian is the only system that: Offers personalized, precision radiation therapy Sees and tracks tumors in real-time Provides automatic beam gating for precise and accurate dosing Enables complete, on-table re-optimization of treatment plans Defining & Delivering A NEW STANDARD OF CARE

SLIDE 8

Key Opinion Leader Perspective Daphne A. Haas-Kogan, MD Chair, Radiation Oncology Dana-Farber Cancer Institute Brigham and Women's Hospital and Boston Children's Hospital Just as the two-dimensional x-rays we relied on in the 1980s were replaced by CT-guided radiotherapy, so will MR-guided radiation technology render CT-guided radiation obsolete.13 “ MRIdian Therapeutically Relevant Imaging MRIdian Enhanced CBCT CBCT images http://medicalaffairs.varian.com/halcyon-images?l=100 “

SLIDE 9

Moments later in treatment Day of treatment planning During treatment MRIdian adapts to changes in size, shape, and location of tumors, organs at risk, and soft tissue  Images courtesy of Henke et al. Int J Radiation Oncol Bio Phys Motion: MRI real-time, on-table adaptive with high-dose, beam-gated therapy Seeing is Believing

SLIDE 10

Making the Invisible Visible M. Salim Siddiqui, MD Director, Stereotactic Radiation Program and MR Simulation Program Henry Ford Cancer Center This would have been unimaginable before MRIdian. “ Image and quote courtesy of Siddiqui, S. (2018). MR Image-Guided RT Case Review: Making the Invisible, Visible. Miami Symposium. Miami, Florida. Retrieved from https://vimeo.com/293473054 “

SLIDE 11

Beyond a Treatment We are advancing cancer care. In the MRIdian vault, this is where we cure cancer. Down the hall they treat it. “ Clinician Amsterdam UMC Upon completing 36Gy in a single fraction to treat lung cancer “

SLIDE 12

How We Win Commercial Organization Customer Service Operational Excellence Therapy Adoption via Innovation, Clinical Data, & Training

SLIDE 13

Bold Commercial Strategy Providing access and serving more patients Built commercial team, building distribution network Initial focus on United States, EMEA, and Japan This is ~70% of market opportunity Markets & Markets, 2015 Radiotherapy Market Global Forecasts 2020

SLIDE 14

Relentless Focus on Operational Excellence Vault readiness Installation Manufacturing efficiencies, supply chain management Driving efficiency across the organization

SLIDE 15

Customer Service Radical customer delight World-class service and support Clinical workflow Innovation, clinical data, and training

SLIDE 16

Extending our leadership position Investing in innovation Machine vision, biologic imaging Simplified workflow Faster treatment times “Groundbreaking” long-term pipeline Game-changing Technological Innovation Therapy Adoption

SLIDE 17

Increase in Overall Survival with simultaneous vanishing of Grade 3+ Toxicity in unresectable pancreatic cancer1,2,3,4 Ability to treat prostate with very high doses in few sessions with very low toxicity5, even in high risk populations12 Ability to treat partial breast with very high doses in few sessions with excellent cosmesis6,7,8,9,10 50% less treatment volumes in whole breast11 Many more examples in lung, liver, oligomets in the abdomen, adrenal tumors, etc. Over 6,500 Patients Treated Globally - Early, Compelling Data Therapy Adoption

SLIDE 18

Selected Fourth Quarter and Full Year 2019 Preliminary Results ©2019 ViewRay, Inc. All rights reserved. Total revenue of approximately $17 million in the fourth quarter of 2019, primarily from three revenue units including one system upgrade, compared to total revenue of $21 million, primarily from four revenue units including  one system upgrade, in the fourth quarter of 2018.  Received four new orders for MRIdian systems totaling approximately $21 million in the fourth quarter of 2019, compared to eight new orders totaling approximately $49 million in the fourth quarter of 2018.  Full year 2019 revenue of approximately $88 million, primarily from 15 revenue units including two system upgrades, compared to 2018 revenue of approximately $81 million, primarily from 13 revenue units including two system upgrades.  Total backlog was approximately $227 million as of December 31, 2019.  Cash and cash equivalents were approximately $227 million as of December 31, 2019. Cash burn in the fourth quarter of 2019, excluding the impact of the December 2019 financing, was approximately $3 million.   Chief Commercial Officer Jim Alecxih will be leaving the company effective January 17, 2020. At this time the company does not intend to backfill the Chief Commercial Officer role. 

SLIDE 19

Investment Highlights Large Market Opportunity Paradigm Shift in MR-technology to Standard of Care Experienced Management Team Growing Clinical Data Compendium In-line with Market Trends: Non-invasive, Precise, Personalized Medicine Investing in Innovation to Extend Lead

SLIDE 20

BOLDLY INNOVATIVE. CLINICALLY DRIVEN. COMMITTED TO CONQUERING CANCER.

SLIDE 21

1 Dr. Henke, ASTRO 2018, https://vimeo.com/298626732#t=458 2 Dr. Bassetti, Miami Symposium 2018, https://vimeo.com/293472071#t=1224 3 Dr. Parikh ASTRO 2017 Abstract, ASTRO 2017 multi-institutional, https://www.redjournal.org/article/S0360-3016(17)32096-5/fulltext 4 Washington University, Abstract from ASTRO 2018, https://www.redjournal.org/article/S0360-3016(18)31888-1/fulltext 5 Dr. Ben Slotman, Amsterdam Symposium March 2018, https://vimeo.com/264778067#t=145 6 Dr. Zoberi, Washington University School of Medicine, ASTRO 2018, https://vimeo.com/300878157#t=980 7 ASTRO Abstract 2018 – single fraction, https://www.redjournal.org/article/S0360-3016(18)31564-5/fulltext 8 ASTRO Abstract 2017 – single fraction, https://www.redjournal.org/article/S0360-3016(17)31788-1/fulltext 9 ASTRO 2016 Abstract – APBI 10 FX BID, https://www.redjournal.org/article/S0360-3016(16)31037-9/fulltext 10 Red Journal Manuscript, https://www.redjournal.org/article/S0360-3016(16)33065-6/abstract 11 Dr. Zoberi, Washington University School of Medicine, ASTRO 2018, https://vimeo.com/300878157#t=860 12 AUMC Prostate Data https://www.redjournal.org/article/S0360-3016(19)33640-5/fulltext 13 Dargan, R. (2017, November). Opportunities abound for radiation oncology in the era of personalized medicine, RSNA: Daily Bulletin, https://rsna2017.rsna.org/dailybulletin/index.cfm?pg=17thu01 Appendix