VJET 8-K
Flyte Aviation, Inc. (VJET)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 8‑K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
November 12, 2020
Ra Medical Systems, Inc.
(Exact name of registrant as specified in its charter)
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Delaware |
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001-38677 |
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38-3661826 |
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(State or other jurisdiction |
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(Commission |
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(IRS Employer |
2070 Las Palmas Drive
Carlsbad, California 92011
(Address of principal executive offices, including zip code)
(760) 804-1648
(Registrant’s telephone number, including area code)
Not Applicable
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction 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)) |
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class |
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Trading Symbol(s) |
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Name of each exchange on which registered |
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Common Stock, par value $0.0001 per share |
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RMED |
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New York Stock Exchange |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
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 November 12, 2020, Ra Medical Systems, Inc. (the "Company") issued a press release announcing its financial results for the three and nine months ended September 30, 2020. The full text of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information in this Item 2.02, and Exhibit 99.1 attached hereto, is being furnished and shall not be deemed "filed" for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section. The information in this current report shall not be incorporated by reference into any registration statement or other document filed with the Securities and Exchange Commission, whether filed before or after the date hereof regardless of any general incorporation language in any such filing, unless the registrant expressly sets forth in such filing that such information is to be considered "filed" or incorporated by reference therein.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
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Exhibit No. |
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Description |
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Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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RA MEDICAL SYSTEMS, INC. |
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Date: November 12, 2020 |
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By: |
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/s/ Andrew Jackson |
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Andrew Jackson |
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Chief Financial Officer |
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(Principal Financial and Accounting Officer) |
Exhibit 99.1
Ra Medical Systems Reports 2020 Third Quarter Financial Results
Conference call begins at 4:30 p.m. Eastern time today
CARLSBAD, Calif. (November 12, 2020) – Ra Medical Systems, Inc. (NYSE: RMED), a medical device company focusing on commercializing excimer laser systems to treat vascular and dermatological diseases, reports financial results for the three and nine months ended September 30, 2020 and provides a business update.
Recent Operational Highlights
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Twelve subjects enrolled in the Company’s atherectomy pivotal clinical trial, for a total of 13 subjects enrolled to date |
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Positive test results support the path to extend the shelf life of future DABRA catheters |
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Next-generation DABRA catheter projects are advancing on or ahead of schedule with prototypes available for in vitro testing |
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The quality improvement program initiated in late 2019 is substantially complete |
“I’m encouraged by the progress we’ve made during the third quarter and in recent weeks, in particular with patient enrollment in our atherectomy pivotal trial and with improvements and enhancements to the DABRA catheter,” said Will McGuire, Ra Medical Systems CEO. “We are executing well on our engineering, clinical and quality initiatives, and I am confident that we will deliver on our milestones.”
Third Quarter Financial Highlights
Net revenue for the third quarter of 2020 was $0.9 million, which consisted of product sales of $0.2 million and service and other revenue of $0.7 million. This compares with net revenue of $1.9 million for the third quarter of 2019, which consisted of product sales of $1.1 million and service and other revenue of $0.8 million.
Net revenue from the vascular segment for the third quarter of 2020 was $0.1 million, compared with $0.2 million for the third quarter of 2019. Net revenue from the dermatology segment was $0.8 million for the third quarter of 2020, compared with $1.7 million for the third quarter of 2019.
Total cost of revenue for the third quarter of 2020 was $1.4 million, compared with $2.4 million for the third quarter of 2019.
Selling, general and administrative expenses for the third quarter of 2020 were $4.9 million, which included $0.8 million in stock-based compensation, compared with $15.9 million for the third quarter of 2019, which included $6.6 million in stock-based compensation. Research and development expenses for the third quarter of 2020 were $2.3 million, compared with $1.2 million for the third quarter of 2019. Research and development expenses for the third quarters of 2020 and 2019 included $0.1 million and $0.3 million of stock-based compensation, respectively.
The net loss for the third quarter of 2020 was $7.8 million, or $0.13 per share, compared with a net loss for the third quarter of 2019 of $17.4 million, or $1.30 per share.
Adjusted EBITDA for the third quarter of 2020 was negative $6.2 million, compared with negative $9.9 million for the third quarter of 2019. Adjusted EBITDA is a non-GAAP measure presented as net loss before depreciation and amortization expense, interest income, interest expense, income taxes and stock-based compensation. For additional information regarding the non-GAAP financial measures discussed in this news release, please see "Non-GAAP Reconciliations" below.
Ra Medical reported cash and cash equivalents of $33.6 million as of September 30, 2020.
Nine Month Financial Highlights
Net revenue for the first nine months of 2020 was $3.2 million, which consisted of product sales of $0.9 million and service and other revenue of $2.3 million. This compares with net revenue of $5.8 million for the first nine months of 2019, which consisted of product sales of $3.3 million and service and other revenue of $2.5 million.
Net revenue from the vascular segment was $0.3 million for the first nine months of 2020, compared with $1.1 million for the first nine months of 2019. Net revenue from the dermatology segment was $2.9 million for the first nine months of 2020, compared with $4.7 million for the first nine months of 2019.
Total cost of revenue for the first nine months of 2020 was $4.2 million, compared with $7.1 million for the first nine months of 2019.
Selling, general and administrative expenses for the first nine months of 2020 were $19.1 million, which included $2.5 million in stock-based compensation, compared with $42.9 million for the first nine months of 2019, which included $19.3 million in stock-based compensation. Research and development expenses for the first nine months of 2020 were $5.6 million, which included $0.3 million in stock-based compensation, compared with $3.7 million for the first nine months of 2019, which included $1.4 million in stock-based compensation.
The net loss for the first nine months of 2020 was $25.6 million, or $0.79 per share, compared with a net loss for the first nine months of 2019 of $47.2 million, or $3.63 per share.
Adjusted EBITDA for the first nine months of 2020 was negative $20.8 million, compared with negative $24.4 million for the first nine months of 2019.
Ra Medical will hold a conference call and audio webcast to discuss this announcement and answer questions at 4:30 p.m. Eastern time today. The conference call dial-in numbers are 866-777-2509 for domestic callers and 412-317-5413 for international callers, and the passcode is 10149446. A live webcast of the call will be available on the Investor Relations section of www.ramed.com.
A recording of the call will be available for 48 hours beginning approximately two hours after the completion of the call by dialing 877-344-7529 for domestic callers, 855-669-9658 for Canadian callers or 412-317-0088 for international callers. Please use the passcode 10149446. A webcast replay will be available on the Investor Relations section of www.ramed.com for 30 days, beginning approximately two hours after the completion of the call.
2
Ra Medical has presented certain financial information in accordance with U.S. GAAP and also on a non-GAAP basis for the three and nine month periods ended September 30, 2020 and September 30, 2019. EBITDA and Adjusted EBITDA are performance measures that provide supplemental information management believes is useful to analysts and investors to evaluate Ra Medical’s ongoing results of operations, when considered alongside other GAAP measures. These measures are intended to aid investors in better understanding Ra Medical’s current financial performance and prospects for the future as seen through management. Management uses non-GAAP measures to compare the company’s performance relative to forecasts and strategic plans and to benchmark the company’s performance externally against competitors. Management believes that these non-GAAP financial measures facilitate comparisons with Ra Medical’s historical results and with the results of peer companies who present similar measures (although other companies may define non-GAAP measures differently than we define them, even when similar terms are used to identify such measures). Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of the company’s operating results as reported under U.S. GAAP. Ra Medical encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP information and the reconciliation between these presentations, to more fully understand its business. Reconciliations between GAAP and non-GAAP operating results are presented in the accompanying tables of this release.
Investors are encouraged to review the related GAAP financial measures and the reconciliation of these non-GAAP financial measures to their most directly comparable GAAP financial measures, and not to rely on any single financial measure to evaluate our business. Ra Medical defines EBITDA as our GAAP net loss as adjusted to exclude depreciation and amortization, interest income, interest expense and income tax expense. Ra Medical defines Adjusted EBITDA as our GAAP net loss as adjusted to exclude depreciation and amortization, interest income, interest expense, income tax expense and stock-based compensation.
About Ra Medical Systems
Ra Medical Systems commercializes excimer lasers and catheters for the treatment of vascular and dermatological diseases. In May 2017, the DABRA excimer laser system received FDA 510(k) clearance in the U.S. for crossing chronic total occlusions, or CTOs, in patients with symptomatic infrainguinal lower extremity vascular disease with an intended use for ablating a channel in occlusive peripheral vascular disease. The Pharos excimer laser system is FDA-cleared and is used as a tool in the treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma. DABRA and Pharos are both based on Ra Medical’s core excimer laser technology platform and deploy similar mechanisms of action. Ra Medical manufactures DABRA and Pharos excimer lasers and catheters in a 32,000-square-foot facility located in Carlsbad, Calif. The vertically integrated facility is ISO 13485 certified and is licensed by the State of California to manufacture sterile, single-use catheters in controlled environments.
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Cautionary Note Regarding Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements generally relate to future events or Ra Medical’s future financial or operating performance. In some cases, you can identify forward-looking statements because they contain words such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “could,” “intends,” “target,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these words or other similar terms or expressions that concern Ra Medical’s future expectations, strategy, plans or intentions. Forward-looking statements in this press release include, but are not limited to, statements regarding Ra Medical’s business strategy. Ra Medical’s expectations and beliefs regarding these matters may not materialize, and actual results in future periods are subject to risks and uncertainties that could cause actual results to differ materially from those projected or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, challenges inherent in developing, manufacturing, launching, marketing, and selling new products; risks associated with acceptance of DABRA and Pharos and procedures performed using such devices by physicians, payors, and other third parties; development and acceptance of new products or product enhancements; clinical and statistical verification of the benefits achieved via the use of Ra Medical’s products; the results from our clinical trials, which may not support intended indications or may require Ra Medical to conduct additional clinical trials or modify ongoing clinical trials; challenges related to commencement, patient enrollment, completion, an analysis of clinical trials; Ra Medical’s ability to manage operating expenses; Ra Medical’s ability to effectively manage inventory; Ra Medical’s ability to recruit and retain management and key personnel; Ra Medical’s need to comply with complex and evolving laws and regulations; intense and increasing competition and consolidation in Ra Medical’s industry; the impact of rapid technological change; costs and adverse results in any ongoing or future legal proceedings; adverse outcome of regulatory inspections; and the other risks and uncertainties described in Ra Medical’s news releases and filings with the Securities and Exchange Commission. Information on these and additional risks, uncertainties, and other information affecting Ra Medical’s business and operating results is contained in Ra Medical’s Annual Report on Form 10-K for the year ended December 31, 2019 and in its other filings with the Securities and Exchange Commission. Additional information will also be set forth in Ra Medical’s Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2020 to be filed with the Securities and Exchange Commission. The forward-looking statements in this press release are based on information available to Ra Medical as of the date hereof, and Ra Medical disclaims any obligation to update any forward-looking statements, except as required by law.
Ra Medical investors and others should note that we announce material information to the public about the company through a variety of means, including our website (www.ramed.com), our investor relations website (https://ir.ramed.com/), press releases, SEC filings and public conference calls in order to achieve broad, non-exclusionary distribution of information to the public and to comply with our disclosure obligations under Regulation FD. We encourage our investors and others to monitor and review the information we make public in these locations as such information could be deemed to be material information. Please note that this list may be updated from time to time.
Contacts
At the Company:
Jeffrey Kraws
President, Ra Medical Systems
760-496-9008
Investors:
LHA Investor Relations
Jody Cain
310-691-7100
4
(Unaudited)
(in thousands)
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September 30, 2020 |
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December 31, 2019 |
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ASSETS |
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Current Assets |
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Cash and cash equivalents |
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$ |
33,646 |
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$ |
14,584 |
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Short-term investments |
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— |
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15,993 |
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Accounts receivable, net |
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475 |
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786 |
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Inventories |
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2,592 |
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2,777 |
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Prepaid expenses and other current assets |
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466 |
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1,860 |
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Total current assets |
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37,179 |
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36,000 |
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Property and equipment, net |
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3,581 |
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5,050 |
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Operating lease right-of-use-assets |
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2,574 |
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2,835 |
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Other non-current assets |
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120 |
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196 |
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TOTAL ASSETS |
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$ |
43,454 |
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$ |
44,081 |
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Current Liabilities |
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Accounts payable |
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$ |
899 |
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$ |
1,532 |
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Accrued expenses |
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4,591 |
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2,642 |
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Current portion of deferred revenue |
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1,729 |
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2,029 |
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Current portion of equipment financing |
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306 |
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293 |
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Current portion of promissory note |
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168 |
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— |
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Current portion of operating lease liabilities |
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346 |
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318 |
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Total current liabilities |
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8,039 |
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6,814 |
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Deferred revenue |
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656 |
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1,232 |
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Equipment financing |
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34 |
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265 |
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Promissory note |
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1,832 |
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— |
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Operating lease liabilities |
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2,355 |
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2,620 |
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Total liabilities |
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12,916 |
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10,931 |
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Total stockholders’ equity |
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30,538 |
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33,150 |
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TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY |
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$ |
43,454 |
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$ |
44,081 |
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5
Condensed Statements of Operations
(Unaudited)
(in thousands, except per share data)
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2020 |
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2019 |
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2020 |
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2019 |
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Net revenue |
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Product sales |
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$ |
183 |
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$ |
1,078 |
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$ |
923 |
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$ |
3,256 |
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Service and other |
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731 |
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830 |
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2,265 |
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2,553 |
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Total net revenue |
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914 |
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1,908 |
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3,188 |
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5,809 |
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Cost of revenue |
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Product sales |
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670 |
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1,518 |
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2,258 |
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4,848 |
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Service and other |
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748 |
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907 |
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1,911 |
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2,252 |
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Total cost of revenue |
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1,418 |
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2,425 |
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4,169 |
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7,100 |
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Gross loss |
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(504 |
) |
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(517 |
) |
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(981 |
) |
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(1,291 |
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Operating expenses |
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Selling, general and administrative |
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4,933 |
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15,889 |
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19,114 |
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42,907 |
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Research and development |
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2,332 |
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1,182 |
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5,580 |
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3,692 |
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Total operating expenses |
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7,265 |
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17,071 |
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24,694 |
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46,599 |
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Operating loss |
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(7,769 |
) |
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(17,588 |
) |
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(25,675 |
) |
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(47,890 |
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Other income (expense), net |
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(10 |
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173 |
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74 |
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684 |
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Loss before income tax expense |
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(7,779 |
) |
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(17,415 |
) |
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(25,601 |
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(47,206 |
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Income tax expense |
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— |
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3 |
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— |
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8 |
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Net loss |
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$ |
(7,779 |
) |
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$ |
(17,418 |
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$ |
(25,601 |
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$ |
(47,214 |
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Basic and diluted net loss per share |
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$ |
(0.13 |
) |
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$ |
(1.30 |
) |
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$ |
(0.79 |
) |
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$ |
(3.63 |
) |
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Basic and diluted weighted average common shares outstanding |
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59,638 |
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13,370 |
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32,443 |
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|
13,023 |
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6
Non-GAAP Reconciliations
(Unaudited)
(in thousands)
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2020 |
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2019 |
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2020 |
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2019 |
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Statements of Operations Data: |
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Net loss |
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$ |
(7,779 |
) |
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$ |
(17,418 |
) |
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$ |
(25,601 |
) |
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$ |
(47,214 |
) |
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Depreciation and amortization |
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631 |
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|
460 |
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1,845 |
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1,291 |
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Interest income |
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(4 |
) |
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(245 |
) |
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(128 |
) |
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(870 |
) |
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Interest expense |
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|
14 |
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|
|
72 |
|
|
|
54 |
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|
|
186 |
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Income tax expense |
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— |
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3 |
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— |
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8 |
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EBITDA |
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(7,138 |
) |
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|
(17,128 |
) |
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(23,830 |
) |
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(46,599 |
) |
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Stock-based compensation |
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964 |
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7,277 |
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3,044 |
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22,154 |
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Adjusted EBITDA |
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$ |
(6,174 |
) |
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$ |
(9,851 |
) |
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$ |
(20,786 |
) |
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$ |
(24,445 |
) |
# # #
7