The conference call begins today at 4:30 PM Eastern Time
Carlsbad, California--(BUSINESS WIRE)--Ra Medical Systems, Inc.(NYSE American: RMED) is a medical device that focuses on developing its excimer laser system to treat vascular diseases The company has reported three-month and nine-month financial results as of September 30, 2021, and provides business updates.
"We are reporting the progress of all key initiatives," said Will McGuire, CEO of Ra Medical Systems. "First, the clinical team promoted the massive recruitment of our key clinical studies to obtain indications for plaque resection. Second, we advanced our engineering efforts to develop a more robust and deliverable DABRA catheter, and we continue to look forward to the next Submit an application to the FDA quarterly to seek regulatory approval for the first next-generation catheter. Third, I continue to be excited about our research work, showing that the DABRA laser system can be used to generate a shock wave large enough to destroy the calcium in the artery, usually called For endovascular lithotripsy, we believe this represents the potential to create significant shareholder value.
"Finally, I would like to commend the Ra Medical team for divesting our dermatology business. As mentioned earlier, we believe that focusing our resources on the huge and growing medical device market to treat PAD is the best way to create shareholder value. It is estimated that between 19 million and 21 million people in the United States suffer from PAD, and the market segment we are targeting is expected to have revenue of over US$900 million this year,” Mr. McGuire added.
Net income for the third quarter of 2021 includes product sales of $5,000. In contrast, net income from continuing operations in the third quarter of 2020 was US$68,000, of which product sales were US$66,000 and service and other income was US$2,000.
The total cost of revenue in the third quarter of 2021 is US$200,000, compared to US$600,000 in the third quarter of 2020.
Sales, general, and administrative expenses for the third quarter of 2021 were US$4.2 million, including US$100,000 in stock compensation, and in the third quarter of 2020, US$4.7 million, including US$800,000 in stock compensation. Research and development expenses for the third quarter of 2021 are US$2.9 million, including US$27,000 in stock compensation, while research and development expenses in the third quarter of 2020 are US$2.3 million, including US$100,000 in stock compensation.
The loss from continuing operations in the third quarter of 2021 was US$7.4 million, or 6.4 million weighted average issued shares was US$1.15 per share, while the loss in the third quarter of 2020 was US$7.5 million, or US$3.15 per share, and the weighted average 2.4 million shares-the average number of shares outstanding.
Adjusted EBITDA for the third quarter of 2021 was negative 6.9 million U.S. dollars, while in the third quarter of 2020 it was negative 6.1 million U.S. dollars. Adjusted EBITDA is a non-GAAP measure expressed as depreciation and amortization expenses, interest income, continuing operating losses before interest expenses, income taxes, stock-based compensation, gains and losses from the sale and disposal of property and equipment, and wages Termination benefits of protection plan (PPP) promissory notes. For more information on the non-GAAP financial measures discussed in this press release, please see "Non-GAAP Reconciliations" below.
Net income for the third quarter of 2021 was US$500,000, of which product sales were US$100,000 and service and other income was US$400,000. In contrast, net income in the third quarter of 2020 was US$800,000, which included US$100,000 in product sales and US$700,000 in service and other revenue.
The total cost of revenue in the third quarter of 2021 is US$400,000, compared to US$900,000 in the third quarter of 2020.
Sales, general, and administrative expenses for the third quarter of 2021 are US$300,000, compared to US$200,000 for the third quarter of 2020. Research and development expenses in the third quarter of 2021 will be US$100,000, compared to US$21,000 in the third quarter of 2020.
The loss caused by the suspension of production in the third quarter of 2021 was US$400,000, while the loss in the third quarter of 2020 was US$300,000.
In the third quarter of 2021, the sales revenue of the dermatology business was 3.5 million U.S. dollars.
In the third quarter of 2021, the revenue/loss of the closed business (including the proceeds from the sale of the dermatology business) was $3.1 million in revenue, or 6.4 million weighted average shares outstanding, and earnings per share of $0.48, compared with a loss in the third quarter. In the first quarter of 2020, US$300,000, or US$0.11 per share, has a weighted average of 2.4 million shares issued.
Net income for the first nine months of 2021 includes product sales of $17,000. In contrast, net income for the first nine months of 2020 is US$300,000, which mainly includes product sales.
The total cost of revenue for the first nine months of 2021 is US$1.2 million, while the total cost of revenue for the first nine months of 2020 is US$1.7 million.
Sales, general and administrative expenses for the first nine months of 2021 are US$11.3 million, including US$1.6 million in stock compensation, while sales, general and administrative expenses for the first nine months of 2020 are US$18.2 million, including 2.4 million Stock compensation in US dollars. The research and development expenses for the first nine months of 2021 are US$8.5 million, including US$300,000 in stock compensation, and the research and development expenses for the first nine months of 2020 are US$5.5 million, including US$300,000 in stock compensation.
The loss from continuing operations for the first nine months of 2021 was US$19 million, or 4.5 million shares issued, a weighted average loss per share of US$4.23, while the loss for the first nine months of 2020 was US$25.1 million, or US$19.32 per share, and 1.3 Million weighted average shares outstanding.
Adjusted EBITDA for the first nine months of 2021 is negative $18.6 million, and for the first nine months of 2020, it is negative $20.8 million. For more information on the non-GAAP financial measures discussed in this press release, please see "Non-GAAP Reconciliations" below.
As of September 30, 2021, Ra Medical reported cash and cash equivalents of $20.6 million.
Net income for the first nine months of 2021 was US$2.6 million, including US$900,000 in product sales and US$1.7 million in service and other income. In comparison, net income for the first nine months of 2020 was US$2.9 million, of which product sales were US$700,000 and service and other income was US$2.2 million.
The total cost of revenue for the first nine months of 2021 is US$2.3 million, while the total cost of revenue for the first nine months of 2020 is US$2.4 million.
Sales, general, and administrative expenses for the first nine months of 2021 are US$1.1 million, and for the first nine months of 2020, they are US$1 million. The research and development expenses for the first nine months of 2021 will be USD 400,000, and the first nine months will be USD 47,000 in 2020.
The loss of business closure in the first nine months of 2021 was US$1.3 million, while the loss in the first nine months of 2020 was US$500,000.
In the first nine months of 2021, sales revenue from the dermatology business was US$3.5 million.
In the first nine months of 2021, the income/loss from discontinued operations (including the proceeds from the sale of the dermatology business) was $2.2 million in revenue, which is a weighted average of 4.5 million shares outstanding at $0.49 per share, compared to the third quarter of 2020 US$500,000, or 1.3 million weighted average shares outstanding, US$0.40 per share.
Ra Medical will hold a conference call and audio webcast at 4:30 pm Eastern time today to discuss this announcement and answer questions. The dial-in number for the conference call is 866-777-2509 for domestic calls, 412-317-5413 for international calls, and 10161581 for passwords. The live broadcast of the call will be available in the investor relations section of www.ramed.com.
Call recording will be provided within about 2 hours after the call ends. Domestic callers dial 877-344-7529, Canadian callers dial 855-669-9658, and international callers dial 412-317-0088. Please use password 10157984. A 30-day web replay will be provided in the Investor Relations section of www.ramed.com, starting approximately two hours after the call ends.
Ra Medical has submitted certain financial information for the three-month and nine-month periods ending September 30, 2021 and September 30, 2020 in accordance with U.S. generally accepted accounting principles and non-GAAP. EBITDA and adjusted EBITDA provide supplementary performance indicators. Information management believes that, when considered together with other GAAP measures, it is useful for analysts and investors to evaluate Ra Medical's continued operating performance. These measures are designed to help investors better understand Ra Medical's current financial performance and the future prospects as seen by management. Management uses non-GAAP measures to compare the company's performance relative to forecasts and strategic plans, and externally compare company performance with competitors. Management believes that these non-GAAP financial measures are useful for comparison with Ra Medical’s historical performance and the performance of peer companies that use similar measures (although other companies’ definitions of non-GAAP measures may differ from our definition of them, even if they are used Similar terms were used to identify such measures). Non-GAAP information is not prepared in accordance with a comprehensive set of accounting rules and can only be used to supplement the understanding of the company's operating performance reported by the US GAAP. Ra Medical encourages investors to carefully consider its results under GAAP, as well as its supplementary non-GAAP information and reconciliations between these presentations in order to gain a more comprehensive understanding of its business. The reconciliations between GAAP and non-GAAP operating results are listed in the table attached to this press release.
Investors are encouraged to review relevant GAAP financial measures and the reconciliation of these non-GAAP financial measures with their most directly comparable GAAP financial measures, rather than relying on any single financial measure to evaluate our business. Ra Medical defines EBITDA as our GAAP continuing operating loss, adjusted to exclude depreciation and amortization, interest income, interest expense and income tax expense. Ra Medical defines adjusted EBITDA as adjusted EBITDA to exclude stock-based compensation, the elimination of gains from PPP promissory notes, and losses (gains) from the sale and disposal of property and equipment.
Ra Medical Systems manufactures DABRA excimer lasers and catheters for the treatment of vascular diseases. DABRA has been approved by the FDA for crossing chronic complete occlusion in patients with symptomatic lower extremity vascular disease and is expected to be used to ablate channels in occlusive peripheral vascular disease. In addition, DABRA has received CE mark approval and can be used for endovascular treatment of subinguinal arteries through plaque resection and span complete occlusion. DABRA breaks down plaques into their basic chemical components, such as proteins, lipids, and other compounds, and eliminates blockages by essentially dissolving them without producing potentially harmful particles. DABRA excimer lasers and catheters are manufactured in a 32,000 square foot facility in Carlsbad, California. The vertically integrated factory is ISO 13485 certified and licensed by the State of California to manufacture sterile disposable catheters in a clean room environment.
Note on 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 information such as "may", "will", "should", "expect", "plan", "anticipate", "may", "intend", " Goal, "project", "consider", "believe", "estimate", "predict", "potential" or "continue" or the negative words of these words or other similar terms or expressions, these words or expressions are the same as Ra Medical Future expectations, strategies, plans or intentions. The forward-looking statements in this press release include but are not limited to Ra Medical’s business strategy, the potential of the DABRA system in new applications, current and potential market opportunities and growth, and their The statement of the ability to continue to develop manages expenses and cash consumption rates at a sustainable level. Ra Medical’s expectations and beliefs on these matters may not be realized, and the actual results in the future period are affected by risks and uncertainties, which may lead to actual results There are material differences with the results predicted or implied by such forward-looking statements. The potential risks and uncertainties that lead to the uncertainty of these statements include the inherent challenges of developing, manufacturing, releasing, marketing and selling new products or new uses; and Accept DABRA equipment for current and potential use applications and risks associated with procedures performed by doctors, payers and other third parties using such equipment; develop and accept new products, product enhancements or use applications; through the use of Ra Medical’s products Clinical and statistical verification of the benefits obtained; our clinical trial results may not support the intended indication, or may require Ra Medical to conduct additional clinical trials or modify ongoing clinical trials; and start, patient registration, completion, and clinical trials Analysis of related challenges; Ra Medical’s ability to manage operating expenses; Ra Medical’s ability to recruit and retain managers and key personnel; Ra Medical’s need to comply with complex and changing laws and regulations; Ra Medical’s fierce and increasingly fierce competition and Integration; the impact of rapid technological change; the unfavorable results of regulatory inspections; and other risks and uncertainties described in Ra Medical’s press releases and filings with the US Securities and Exchange Commission. These and other risks, uncertainties, and impacts Other information on Ra Medical’s business and operating performance is contained in Ra Medical’s annual report on Form 10-K for the year ended December 31, 2020 and other documents filed with the U.S. Securities and Exchange Commission. Ra Medical to the U.S. Securities and Exchange Commission Additional information is contained in the Committee’s quarterly report on Form 10-Q for the quarter ended September 30, 2021. The forward-looking statements in this press release are based on information available to Ra Medical as of the date of this press release, except Except as required by law, Ra Medical assumes no obligation to update any forward-looking statements .
Ra Medical investors and others should note that we publish important information about the company to the public in various ways, including our website (www.ramed.com), our investor relations website (https://ir.ramed .com/ ), press releases, SEC documents, and public conference calls to achieve a wide, non-exclusive distribution of information to the public, and to comply with our disclosure obligations under the regulation FD. We encourage our investors and others to monitor and review the information we disclose in these places, as this information may be considered important information. Please note that this list may be updated from time to time.
Prepaid expenses and other liquid assets
Discontinued current assets
Discontinued long-term assets
Current portion of operating lease liabilities
The current part of equipment financing
The current part of the PPP promissory note
Current liabilities of discontinued operations
Discontinued long-term liabilities
Total liabilities and shareholders' equity
(In thousands, except per share data)
Loss from continuing operations before income tax
Income (loss) from discontinued operations before income tax (including sales proceeds of $3,500)
Income from discontinuation (loss)
Net (loss) income per share, basic and diluted
Total net loss per share, basic and diluted
Basic and diluted weighted average common shares outstanding
In the company: Andrew Jackson Chief Financial Officer, Ra Medical Systems 760-496-9540 ajackson@ramed.com
Investor: LHA Investor Relations Jody Cain 310-691-7100 jcain@lhai.com
In the company: Andrew Jackson Chief Financial Officer, Ra Medical Systems 760-496-9540 ajackson@ramed.com
Investor: LHA Investor Relations Jody Cain 310-691-7100 jcain@lhai.com