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):

 

August 11, 2020

 

Ra Medical Systems, Inc.

(Exact name of registrant as specified in its charter)

 

 

Delaware

 

001-38677

 

38-3661826

(State or other jurisdiction
of incorporation)

 

(Commission
File Number)

 

(IRS Employer
Identification No.)

 

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):

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 $0.0001 per share

 

RMED

 

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 August 11, 2020, Ra Medical Systems, Inc. (the "Company") issued a press release announcing its financial results for the three and six months ended June 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

 

Exhibit No.

 

Description

 

 

 

99.1

 

Press release dated August 11, 2020.

 

 

 

 


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 hereunto duly authorized.

 

 

 

 

 

RA MEDICAL SYSTEMS, INC.

 

 

 

 

 

Date: August 11, 2020

 

By:

 

/s/ Andrew Jackson

 

 

 

 

Andrew Jackson

 

 

 

 

Chief Financial Officer

 

 

 

 

(Principal Financial and Accounting Officer)

 

 

Exhibit 99.1

 

Ra Medical Systems Reports 2020 Second Quarter Financial Results

 

Conference call begins at 4:30 p.m. Eastern time today

 

CARLSBAD, Calif. (August 11, 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 six months ended June 30, 2020 and provides a business update.

 

Recent Operational Highlights

 

 

Identified fundamental contributors to DABRA catheter shelf life limitations and began pursuing mitigations

 

Filled additional key roles in engineering, quality assurance and clinical affairs to further advance critical R&D projects, quality improvement plan initiatives and the atherectomy clinical study

 

Cleared third U.S. site to begin enrollment in the FDA-approved IDE clinical study to obtain an atherectomy indication

 

Received $19.3 million in net proceeds from two public equity offerings

 

“I’m encouraged by our progress during the second quarter and recent weeks, particularly with our engineering efforts on the various DABRA catheter initiatives.  We have added substantial engineering resources this year through hiring skilled personnel and engaging experienced consultants.  I am confident we have the right team in place to achieve our engineering milestones,” said Will McGuire, Ra Medical Systems CEO.  “We are operating in two large and growing markets, and are committed to our mission of saving limbs and lives.”

 

Second Quarter Financial Highlights

 

Net revenue for the second 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 $2.2 million for the second quarter of 2019, which consisted of product sales of $1.3 million and service and other revenue of $0.9 million.  

 

Net revenue from the vascular segment for the second quarter of 2020 was $0.1 million, compared with $0.4 million for the second quarter of 2019. Net revenue from the dermatology segment was $0.8 million, compared with $1.8 million for the second quarter of 2019.  

 

Total cost of revenue for the second quarter of 2020 was $1.2 million, compared with $2.7 million for the second quarter of 2019.

 

Selling, general and administrative expenses for the second quarter of 2020 were $7.9 million, which included $0.8 million in stock-based compensation, compared with $13.8 million for the second quarter of 2019, which included $6.4 million in stock-based compensation. Research and development expenses for the second quarter of 2020 were $2.0 million, compared with $1.0 million for the second quarter of 2019. Research and development expenses for the second quarters of 2020 and 2019 included $0.1 million and $0.3 million of stock-based compensation, respectively.

 

The net loss for the second quarter of 2020 was $10.1 million, or $0.43 per share, compared with a net loss for the second quarter of 2019 of $15.1 million, or $1.16 per share.

 

Adjusted EBITDA for the second quarter of 2020 was negative $8.4 million, compared with negative $7.8 million for the second 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 $29.4 million as of June 30, 2020.

 

Six Month Financial Highlights

 

Net revenue for the first six months of 2020 was $2.3 million, which consisted of product sales of $0.7 million and service and other revenue of $1.6 million. This compares with net revenue of $3.9 million for the first six months of 2019, which consisted of product sales of $2.2 million and service and other revenue of $1.7 million.  

 

Net revenue from the vascular segment was $0.2 million for the first six months of 2020, compared with $0.9 million for the first six months of 2019. Net revenue from the dermatology segment was $2.1 million for the first six months of 2019, compared with $3.0 million for the first six months of 2019.  

 

Total cost of revenue for the first six months of 2020 was $2.8 million, compared with $4.7 million for the first six months of 2019.

 

Selling, general and administrative expenses for the first six months of 2020 were $14.2 million, which included $1.7 million in stock-based compensation, compared with $27.0 million for the first six months of 2019, which included $12.7 million in stock-based compensation. Research and development expenses for the first six months of 2020 were $3.2 million, which included $0.2 million in stock-based compensation, compared with $2.5 million for the first six months of 2019, which included $1.2 million in stock-based compensation.

 

The net loss for the first six months of 2020 was $17.8 million, or $0.95 per share, compared with a net loss for the first six months of 2019 of $29.8 million, or $2.32 per share.

 

Adjusted EBITDA for each of the first six months of 2020 and 2019 was negative $14.6 million. 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.

 

Conference Call and Webcast

 

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 866-789-3291 for domestic callers and 409-937-8946 for international callers, and the passcode is 5978409. A live webcast of the call will be available on the Investors 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 855-859-2056 for domestic callers or 404-537-3406 for international callers. Please use the passcode 5978409. A webcast replay will be available on the Investors section of www.ramed.com for 30 days, beginning approximately two hours after the completion of the call.

 

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Non-GAAP Financial Measures

 

Ra Medical has presented certain financial information in accordance with U.S. GAAP and also on a non-GAAP basis for the three and six month periods ended June 30, 2020 and June 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 June 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

jkraws@ramed.com

 

Investors:

LHA Investor Relations

Jody Cain

310-691-7100

jcain@lhai.com

 

4

 


Ra Medical Systems, Inc.

Condensed Balance Sheets

(Unaudited)

(in thousands)

 

 

 

June 30,

2020

 

 

December 31,

2019

 

ASSETS

 

 

 

 

 

 

 

 

Current Assets

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

29,380

 

 

$

14,584

 

Short-term investments

 

 

 

 

 

15,993

 

Accounts receivable, net

 

 

474

 

 

 

786

 

Inventories

 

 

2,704

 

 

 

2,777

 

Prepaid expenses and other current assets

 

 

1,221

 

 

 

1,860

 

Total current assets

 

 

33,779

 

 

 

36,000

 

Property and equipment, net

 

 

4,106

 

 

 

5,050

 

Operating lease right-of-use-assets

 

 

2,662

 

 

 

2,835

 

Other non-current assets

 

 

144

 

 

 

196

 

TOTAL ASSETS

 

$

40,691

 

 

$

44,081

 

 

 

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

Current Liabilities

 

 

 

 

 

 

 

 

Accounts payable

 

$

1,870

 

 

$

1,532

 

Accrued expenses

 

 

3,937

 

 

 

2,642

 

Current portion of deferred revenue

 

 

1,859

 

 

 

2,029

 

Current portion of equipment financing

 

 

301

 

 

 

293

 

Current portion of operating lease liabilities

 

 

337

 

 

 

318

 

Total current liabilities

 

 

8,304

 

 

 

6,814

 

Deferred revenue

 

 

846

 

 

 

1,232

 

Equipment financing

 

 

112

 

 

 

265

 

Promissory note

 

 

2,000

 

 

 

 

Operating lease liabilities

 

 

2,445

 

 

 

2,620

 

Total liabilities

 

 

13,707

 

 

 

10,931

 

Total stockholders’ equity

 

 

26,984

 

 

 

33,150

 

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

 

$

40,691

 

 

$

44,081

 

 

5

 


Ra Medical Systems, Inc.

Condensed Statements of Operations

(Unaudited)

(in thousands, except per share data)

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Net revenue

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Product sales

 

$

154

 

 

$

1,284

 

 

$

740

 

 

$

2,178

 

Service and other

 

 

746

 

 

 

869

 

 

 

1,534

 

 

 

1,723

 

Total net revenue

 

 

900

 

 

 

2,153

 

 

 

2,274

 

 

 

3,901

 

Cost of revenue

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Product sales

 

 

624

 

 

 

1,935

 

 

 

1,588

 

 

 

3,330

 

Service and other

 

 

543

 

 

 

798

 

 

 

1,163

 

 

 

1,345

 

Total cost of revenue

 

 

1,167

 

 

 

2,733

 

 

 

2,751

 

 

 

4,675

 

Gross loss

 

 

(267

)

 

 

(580

)

 

 

(477

)

 

 

(774

)

Operating expenses

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Selling, general and administrative

 

 

7,896

 

 

 

13,789

 

 

 

14,181

 

 

 

27,018

 

Research and development

 

 

1,953

 

 

 

979

 

 

 

3,248

 

 

 

2,510

 

Total operating expenses

 

 

9,849

 

 

 

14,768

 

 

 

17,429

 

 

 

29,528

 

Operating loss

 

 

(10,116

)

 

 

(15,348

)

 

 

(17,906

)

 

 

(30,302

)

Other income (expense), net

 

 

(5

)

 

 

231

 

 

 

84

 

 

 

511

 

Loss before income tax expense

 

 

(10,121

)

 

 

(15,117

)

 

 

(17,822

)

 

 

(29,791

)

Income tax expense

 

 

 

 

 

5

 

 

 

 

 

 

5

 

Net loss

 

$

(10,121

)

 

$

(15,122

)

 

$

(17,822

)

 

$

(29,796

)

Basic and diluted net loss per share

 

$

(0.43

)

 

$

(1.16

)

 

$

(0.95

)

 

$

(2.32

)

Basic and diluted weighted average common shares outstanding

 

 

23,621

 

 

 

13,000

 

 

 

18,696

 

 

 

12,847

 

 

6

 


Ra Medical Systems, Inc.

Non-GAAP Reconciliations

(Unaudited)

(in thousands)

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Statements of Operations Data:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(10,121

)

 

$

(15,122

)

 

$

(17,822

)

 

$

(29,796

)

Depreciation and amortization

 

 

636

 

 

 

447

 

 

 

1,214

 

 

 

831

 

Interest income

 

 

(10

)

 

 

(297

)

 

 

(124

)

 

 

(625

)

Interest expense

 

 

15

 

 

 

66

 

 

 

40

 

 

 

114

 

Income tax expense

 

 

 

 

 

5

 

 

 

 

 

 

5

 

EBITDA

 

 

(9,480

)

 

 

(14,901

)

 

 

(16,692

)

 

 

(29,471

)

Stock-based compensation

 

 

1,033

 

 

 

7,132

 

 

 

2,080

 

 

 

14,877

 

Adjusted EBITDA

 

$

(8,447

)

 

$

(7,769

)

 

$

(14,612

)

 

$

(14,594

)

 

 

#  #  #

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