UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended September 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period From to Commission file number: 001-38677 Ra Medical Systems, Inc. (Exact name of Registrant as specified in its charter) (State or other jurisdiction of incorporation or ...

Revenue Performance - Total net revenue for Q2 2021 was $1,005,000, an increase of 11.7% compared to $900,000 in Q2 2020[113]. - Product sales increased to $318,000 in Q2 2021 from $154,000 in Q2 2020, a growth of 106.5%[113]. - Service and other revenue decreased to $687,000 in Q2 2021 from $746,000 in Q2 2020, a decline of 7.9%[113]. - Total net revenue for the three months ended June 30, 2021, was $1.005 million, an increase of $105,000 compared to $900,000 in 2020[115]. - Vascular segment net revenue decreased to $9,000 for the three months ended June 30, 2021, down from $78,000 in 2020, a decline of approximately 88.5%[116]. - Dermatology segment net revenue increased to $996,000 for the three months ended June 30, 2021, up from $822,000 in 2020, an increase of approximately 21.2%[119]. Expenses and Losses - Gross loss for Q2 2021 was $(483,000), compared to $(267,000) in Q2 2020, reflecting a deterioration of 81%[113]. - Selling, general and administrative expenses decreased significantly to $3,741,000 in Q2 2021 from $7,896,000 in Q2 2020, a reduction of 47.4%[113]. - Research and development expenses increased to $3,018,000 in Q2 2021 from $1,953,000 in Q2 2020, an increase of 54.6%[113]. - The operating loss for Q2 2021 was $(7,242,000), an improvement of 28.5% compared to $(10,116,000) in Q2 2020[113]. - Gross loss for the three months ended June 30, 2021, was $483,000, compared to a gross loss of $267,000 in 2020, an increase of approximately 80.9%[126]. - Selling, general and administrative (SG&A) expenses decreased to $3.7 million for the three months ended June 30, 2021, down from $7.9 million in 2020, a decrease of approximately 53.2%[133]. - Research and development (R&D) expenses increased to $3.0 million for the three months ended June 30, 2021, up from $2.0 million in 2020, an increase of 50%[135]. - Adjusted EBITDA for the three months ended June 30, 2021, was negative $6.1 million, an improvement from negative $8.4 million in 2020[142]. Cash Flow and Financing - As of June 30, 2021, the company had cash and cash equivalents of $20.2 million and an accumulated deficit of $165.7 million[144]. - Net cash used in operating activities for the six months ended June 30, 2021, was $14.7 million, compared to $12.8 million for the same period in 2020[150][151]. - Net cash provided by financing activities was $10.6 million for the six months ended June 30, 2021, primarily from an "at the market" offering[154]. - Net cash provided by investing activities was $0.5 million for the six months ended June 30, 2021, a significant decrease from $16.0 million in the same period in 2020[153]. Future Outlook and Concerns - The company expects net revenue to continue to be negatively impacted by the COVID-19 pandemic, as patients postpone voluntary treatments and physician offices operate at reduced capacity[118]. - The company expects operating losses and negative cash flows to continue due to costs related to clinical trials and ongoing litigation, exacerbated by the COVID-19 pandemic[145]. - The company plans to address liquidity concerns by potentially raising additional funds through public or private equity or debt financings[148]. - Future capital requirements will depend on the successful completion of clinical trials and the revenue generated from product sales, particularly DABRA and Pharos products[147]. - The company incurred significant legal and related expenses, which are expected to remain high in the near term due to ongoing legal proceedings[146]. - The company continues to analyze opportunities for cost reductions, including potential workforce reductions and deferring capital expenditures[145]. - The company has raised substantial doubt about its ability to continue as a going concern for at least 12 months from the date of the financial statements due to ongoing uncertainties[148]. Clinical and Product Development - The company enrolled 69 subjects in its pivotal study for atherectomy indication as of August 2, 2021, with the study approved for up to 100 subjects[100]. - The DABRA catheter's shelf life is expected to be at least six months based on internal real-time aging test data[98]. - The company is evaluating multiple strategic options for its dermatology business, including potential investments and partnerships[102].

Revenue Performance - Total net revenue for the three months ended March 31, 2021, was $1.118 million, a decrease of $256,000 from $1.374 million in the same period of 2020[107]. - Product sales decreased to $406,000 in Q1 2021 from $586,000 in Q1 2020, a decline of 30.7%[107]. - Service and other revenue also declined to $712,000 in Q1 2021 from $788,000 in Q1 2020, a decrease of 9.6%[107]. - The vascular segment generated minimal revenue of $4,000 in Q1 2021 compared to $113,000 in Q1 2020, reflecting a decrease of 96.5%[109]. - Dermatology segment revenue was $1.114 million in Q1 2021, down from $1.261 million in Q1 2020, a decrease of approximately 11.7%[111]. Expenses and Losses - Gross loss for Q1 2021 was $255,000, compared to a gross loss of $210,000 in Q1 2020, indicating a worsening of 21.4%[107]. - Total operating expenses decreased to $6.930 million in Q1 2021 from $7.580 million in Q1 2020, a reduction of $650,000[107]. - Research and development expenses increased to $2.816 million in Q1 2021 from $1.295 million in Q1 2020, an increase of 117.5%[107]. - SG&A expenses decreased by $2.2 million to $4.1 million, primarily due to reductions in legal expenses and other cost-saving measures[118]. - Management expects continued operating losses and negative cash flows due to ongoing clinical trials and the impact of the COVID-19 pandemic[128]. Cash Flow and Financial Position - Net cash used in operating activities was $8.1 million for the three months ended March 31, 2021, compared to $7.0 million in 2020[134][135]. - Cash and cash equivalents as of March 31, 2021, were $16.0 million, with an accumulated deficit of $160.4 million[127]. - Adjusted EBITDA was negative $6.1 million for the three months ended March 31, 2021, slightly improved from negative $6.2 million in 2020[126]. - As of March 31, 2021, the company had cash and cash equivalents of $16.0 million, which included net proceeds of $19.1 million from 2020 public offerings and $2.0 million from a Paycheck Protection Program loan[144]. Operational Impact and Future Outlook - The company expects continued negative impacts on revenue due to the COVID-19 pandemic, affecting both patient treatments and clinical trial enrollments[97]. - The company is focusing on obtaining an atherectomy indication for the DABRA catheter, with a pivotal study approved for up to 10 clinical sites and 100 subjects[93]. - Research and development expenses increased by $1.5 million to $2.8 million, driven by personnel, consulting expenses, and clinical study costs related to next-generation catheters[120]. Financial Policies and Risks - The company does not engage in off-balance sheet arrangements and had no material changes to contractual obligations during the reported period[141][142]. - A hypothetical 10% relative change in interest rates would not have had a material impact on the company's financial statements due to the short-term nature of cash and cash equivalents[145]. - Revenue is primarily denominated in U.S. dollars, and a 10% adverse change in foreign exchange rates would not have been material for the periods presented[146]. - The company has not entered into any material foreign currency hedging contracts but may consider doing so in the future as operations grow internationally[146]. - Inflation has not had a material effect on the company's business, but significant inflationary pressures could harm its financial condition[147]. - There have been no significant changes to critical accounting policies or estimates since the last annual report[139]. - The company believes that actual results may differ from estimates and assumptions made in financial reporting, which could be material[140]. - The investment policy focuses on liquidity and capital preservation, avoiding trading or speculative investments[144]. - The company does not have material exposure to changes in the fair value of assets due to interest rate fluctuations[145].

Ra Medical Systems, Inc. (RMED) Q1 2021 Earnings Conference Call May 11, 2021 4:30 PM ET Company Participants Jody Cain - LHA Investor Relations Will McGuire - Chief Executive Officer Andrew Jackson - Chief Financial Officer Conference Call Participants Operator Welcome to the Ra Medical Systems First Quarter 2021 Financial Results Conference Call. All participants will be in a listen-only mode. [Operator Instructions] At this time, I'd like to turn the conference call over to Jody Cain. Please go ahead. Jo ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Fiscal Year Ended December 31, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION item13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period From to Commission file number: 001-38677 Ra Medical Systems, Inc. (Exact name of Registrant as specified in its charter) Delaware 38-3661826 (State or other jurisdiction of i ...

PART I. FINANCIAL INFORMATION [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) The company's Q3 2020 financial statements reflect significant revenue decline, continued net losses, and increased cash from financing, with substantial doubt about its going concern status [Condensed Balance Sheets](index=3&type=section&id=Condensed%20Balance%20Sheets) As of September 30, 2020, cash significantly increased to **$33.6 million** due to financing, while total assets slightly decreased and accumulated deficit grew to **$142.8 million** Condensed Balance Sheet Highlights (in thousands) | Balance Sheet Item | Sep 30, 2020 | Dec 31, 2019 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $33,646 | $14,584 | | Total current assets | $37,179 | $36,000 | | TOTAL ASSETS | $43,454 | $44,081 | | **Liabilities & Equity** | | | | Total current liabilities | $8,039 | $6,814 | | Total liabilities | $12,916 | $10,931 | | Accumulated deficit | ($142,758) | ($117,157) | | Total stockholders' equity | $30,538 | $33,150 | | TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $43,454 | $44,081 | [Condensed Statements of Operations](index=4&type=section&id=Condensed%20Statements%20of%20Operations) Q3 2020 net revenue decreased **52%** to **$0.9 million** due to lower product sales, resulting in a **$7.8 million** net loss despite reduced operating expenses Statement of Operations Summary (in thousands, except per share data) | Metric | Q3 2020 | Q3 2019 | Nine Months 2020 | Nine Months 2019 | | :--- | :--- | :--- | :--- | :--- | | Total net revenue | $914 | $1,908 | $3,188 | $5,809 | | Gross loss | ($504) | ($517) | ($981) | ($1,291) | | Selling, general and administrative | $4,933 | $15,889 | $19,114 | $42,907 | | Research and development | $2,332 | $1,182 | $5,580 | $3,692 | | Operating loss | ($7,769) | ($17,588) | ($25,675) | ($47,890) | | Net loss | ($7,779) | ($17,418) | ($25,601) | ($47,214) | | Basic and diluted net loss per share | ($0.13) | ($1.30) | ($0.79) | ($3.63) | [Condensed Statements of Cash Flows](index=6&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) For the nine months ended September 30, 2020, net cash used in operations improved, while **$22.0 million** from financing activities led to a **$19.1 million** net increase in cash Cash Flow Summary for Nine Months Ended Sep 30 (in thousands) | Cash Flow Activity | 2020 | 2019 | | :--- | :--- | :--- | | Net cash used in operating activities | ($18,890) | ($23,601) | | Net cash provided by (used in) investing activities | $15,928 | ($25,984) | | Net cash provided by (used in) financing activities | $22,024 | ($218) | | **Net change in cash and cash equivalents** | **$19,062** | **($49,803)** | [Notes to Condensed Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) Notes highlight substantial doubt about going concern, COVID-19 impact, **$19.1 million** raised from public offerings, and ongoing SEC/DOJ investigations with a **$2.7 million** accrual - The company's ability to continue as a going concern is in **substantial doubt** due to recurring net losses, negative cash flows, and ongoing COVID-19 uncertainty[25](index=25&type=chunk)[29](index=29&type=chunk) - The COVID-19 pandemic is expected to continue adversely impacting revenue and delaying enrollment in the company's atherectomy clinical trial[23](index=23&type=chunk)[27](index=27&type=chunk) - The company is subject to active investigations by the **SEC** and **DOJ** regarding potential violations, with a **$2.7 million** accrual for the DOJ False Claims Act investigation[84](index=84&type=chunk)[85](index=85&type=chunk) - In May and August 2020, the company completed public offerings, raising aggregate net proceeds of approximately **$19.1 million**[69](index=69&type=chunk)[72](index=72&type=chunk) - In May 2020, the company received a **$2.0 million** loan under the Paycheck Protection Program (PPP), potentially forgivable if used for eligible purposes[59](index=59&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses DABRA catheter improvements, COVID-19 clinical trial delays, Q3 2020 revenue decline, reduced operating expenses, bolstered liquidity, and ongoing going concern doubts [Overview and Recent Developments](index=20&type=section&id=Overview%20and%20Recent%20Developments) Ra Medical focuses on improving DABRA catheter and advancing its atherectomy clinical trial, which faces COVID-19 delays, while commercial shipments are paused until Q1 2021 - The company's vascular strategy focuses on engineering efforts to improve the **DABRA catheter's shelf life, robustness, and guidewire compatibility**[106](index=106&type=chunk)[112](index=112&type=chunk) - The company is conducting a pivotal IDE clinical study for an atherectomy indication, but enrollment is substantially delayed by the **COVID-19 pandemic**[107](index=107&type=chunk)[108](index=108&type=chunk) - Commercial shipments of DABRA catheters are paused due to shelf-life stability issues, with resolution and FDA approval expected in **Q1 2021**[109](index=109&type=chunk) [Results of Operations](index=23&type=section&id=Results%20of%20Operations) Q3 2020 net revenue decreased **52%** to **$0.9 million** across both segments, while SG&A expenses significantly declined, and R&D expenses increased, leading to improved Adjusted EBITDA Net Revenue by Segment (in thousands) | Segment | Q3 2020 | Q3 2019 | Change $ | | :--- | :--- | :--- | :--- | | Vascular | $68 | $226 | ($158) | | Dermatology | $846 | $1,682 | ($836) | | **Total net revenue** | **$914** | **$1,908** | **($994)** | - SG&A expenses for Q3 2020 decreased by **$11.0 million** year-over-year, primarily due to lower stock-based compensation, legal expenses, and personnel costs[139](index=139&type=chunk) - R&D expenses for Q3 2020 increased by **$1.1 million** year-over-year, driven by higher personnel, consulting, and supply costs for catheter improvement initiatives[141](index=141&type=chunk) Reconciliation of Net Loss to Adjusted EBITDA (in thousands) | Metric | Q3 2020 | Q3 2019 | | :--- | :--- | :--- | | Net loss | ($7,779) | ($17,418) | | Depreciation and amortization | 631 | 460 | | Interest income | (4) | (245) | | Interest expense | 14 | 72 | | Income tax expense | — | 3 | | Stock-based compensation | 964 | 7,277 | | **Adjusted EBITDA** | **($6,174)** | **($9,851)** | [Liquidity and Capital Resources](index=27&type=section&id=Liquidity%20and%20Capital%20Resources) As of September 30, 2020, the company had **$33.6 million** in cash, bolstered by **$19.1 million** from offerings and a **$2.0 million** PPP loan, but substantial doubt about going concern persists - As of September 30, 2020, the company had cash and cash equivalents of **$33.6 million** and an accumulated deficit of **$142.8 million**[150](index=150&type=chunk) - The company raised net proceeds of **$19.1 million** from public offerings in 2020 and received a **$2.0 million** PPP loan[150](index=150&type=chunk)[151](index=151&type=chunk) - Cost-saving initiatives included reducing the DABRA sales force from **34 employees** to **five clinical specialists**[152](index=152&type=chunk) - Management concluded that **substantial doubt** exists about the company's ability to continue as a going concern within 12 months from the financial statements' issuance[155](index=155&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=30&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company reports minimal material exposure to market risks, including interest rate and foreign currency exchange risks, due to its short-term cash and U.S. dollar denominated revenues - The company believes it has no material exposure to changes in fair value from interest rate changes due to the **short-term nature of its cash and cash equivalents**[170](index=170&type=chunk) - Foreign currency exchange risk is not considered material as revenues are denominated in **U.S. dollars** and international operations are limited[171](index=171&type=chunk) [Item 4. Controls and Procedures](index=31&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of September 30, 2020, with no material changes in internal control over financial reporting - Management concluded that as of September 30, 2020, the company's disclosure controls and procedures were **effective** at the reasonable assurance level[175](index=175&type=chunk) - No material changes in internal control over financial reporting occurred during the three months ended September 30, 2020[176](index=176&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=32&type=section&id=Item%201.%20Legal%20Proceedings) The company faces significant legal challenges, including a securities class action lawsuit and multiple ongoing government investigations by the SEC and DOJ, with a **$2.7 million** accrual - The company is defending against a **securities class action lawsuit** alleging material misstatements in its IPO registration statement and disclosures[179](index=179&type=chunk) - The company is subject to an **SEC investigation** and separate **civil and criminal investigations by the DOJ**[182](index=182&type=chunk)[184](index=184&type=chunk)[185](index=185&type=chunk) - The DOJ's civil investigation concerns potential **False Claims Act violations**, with a **$2.7 million** accrual for this matter[184](index=184&type=chunk) [Item 1A. Risk Factors](index=34&type=section&id=Item%201A.%20Risk%20Factors) The company faces high risks including substantial doubt about going concern, DABRA product issues, intense competition, regulatory compliance, ongoing government investigations, and potential NYSE delisting - There is **substantial doubt** about the company's ability to continue as a going concern, requiring additional financing[196](index=196&type=chunk) - The company's success is highly dependent on the **DABRA catheter**, which faces unresolved performance, shelf life, and calibration issues leading to paused commercial sales[198](index=198&type=chunk)[199](index=199&type=chunk) - The company is subject to active and ongoing **government investigations (DOJ, SEC)** and litigation that may adversely affect its business[219](index=219&type=chunk)[220](index=220&type=chunk) - The company must comply with **NYSE's continued listing requirements**, including minimum share price and market capitalization, to avoid delisting[407](index=407&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=82&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered equity sales occurred; remaining IPO proceeds will fund the atherectomy clinical trial, DABRA catheter improvements, and general corporate purposes - There were **no unregistered sales of equity securities** in the reported period[440](index=440&type=chunk) - The company intends to use remaining IPO proceeds for its **atherectomy clinical trial**, DABRA catheter improvements, and general corporate purposes[443](index=443&type=chunk) [Item 5. Other Information](index=83&type=section&id=Item%205.%20Other%20Information) Jeffrey Kraws, the company's President, provided notice of his resignation effective January 15, 2021 - Jeffrey Kraws, the Company's President, announced his resignation effective **January 15, 2021**[447](index=447&type=chunk)

Ra Medical Systems, Inc. (SPH) Q4 2020 Earnings Conference Call November 12, 2020 4:30 PM ET Company Participants Jody Cain - Lippert/Heilshorn & Associates Will McGuire - CEO Andrew Jackson - CFO Conference Call Participants Adam Maeder - Piper Sandler Anthony Vendetti - Maxim Group Operator Ladies and gentlemen, thank you for standing by. Welcome to the Ra Medical Systems Third Quarter 2020 Conference Call. As a reminder, this call is being recorded November 12, 2020. [Operator Instructions]. I'd now like ...

Product & Technology - DABRA is an excimer laser system with disposable catheters for treating peripheral artery disease (PAD) by crossing total chronic occlusions (CTOs) and ablating a channel[7] - DABRA utilizes photoablation to disintegrate plaque in the artery and is designed to track the patient's true lumen[8,19] - PHAROS, using the same laser platform as DABRA, has US FDA 510(k) clearance and Europe CE Mark for treating psoriasis, vitiligo, atopic dermatitis, and leukoderma[8] Clinical & Market - In a pivotal study, DABRA demonstrated 94% effectiveness in successful crossing of target lesions based on angiographic analysis[26] - The company targets a $1.1 billion global annual total addressable market (TAM) with over 17 million PAD sufferers in the US[9,28] - Only 20% to 30% of peripheral artery disease patients are actively being treated[12,28] Financials - For the six months ended June 30, 2020, total net revenue was $2.274 million, including $191 thousand from vascular and $2.083 million from dermatology[53] - For the year ended December 31, 2019, total net revenue was $7.199 million, including $1.275 million from vascular and $5.924 million from dermatology[53] - As of June 30, 2020, the company had $29.380 million in cash and cash equivalents and short-term investments[55]

Ra Medical Systems, Inc. (RMED) Q2 2020 Earnings Conference Call August 11, 2020 4:30 PM ET Company Participants Jody Cain - Lippert/Heilshorn & Associates Jonathan McGuire - CEO & Director Andrew Jackson - CFO Conference Call Participants Andrew Stafford - Piper Sandler & Co. Anthony Vendetti - Maxim Group Operator Ladies and gentlemen, thank you for standing by. Welcome to the Ra Medical Systems Second Quarter 2020 Conference Call. As a reminder, this call is being recorded today, August 11, 2020. [Operat ...

Ra Medical Systems, Inc. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended June 30, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period From to Commission file number: 001-38677 (Exact name of Registrant as specified in its charter) (State or other jurisdiction of incorporation or orga ...