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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 9, 2023
| STEREOTAXIS, INC. |
| (Exact Name of Registrant as Specified in Its Charter) |
| Delaware |
| (State or Other Jurisdiction of Incorporation) |
| 001-36159 | 94-3120386 | |
| (Commission File Number) | (IRS Employer Identification No.) |
| 710 North Tucker Boulevard, Suite 110, St. Louis, Missouri | 63101 | |
| (Address of Principal Executive Offices) | (Zip Code) |
| (314) 678-6100 |
| (Registrant’s Telephone Number, Including Area Code) |
| (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:
| ☐ | 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)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
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 $0.001 per share | STXS | NYSE American LLC |
| Item 2.02 | Results of Operations and Financial Condition |
On November 9, 2023, Stereotaxis, Inc. (the “Company”) issued a press release (the “Earnings Press Release”) setting forth its financial results for the 2023 third quarter. A copy of the Earnings Press Release is being filed as Exhibit 99.1 hereto, and the statements contained therein are incorporated by reference herein.
Forward-Looking Statements and Additional Information
Statements are made herein or incorporated herein that are “forward-looking statements” as defined by the Securities and Exchange Commission (the “SEC”). All statements, other than statements of historical fact, included or incorporated herein that address activities, events or developments that the Company expects, believes or anticipates will or may occur in the future are forward-looking statements. These statements are not guarantees of future events or the Company’s future performance and are subject to risks, uncertainties and other important factors that could cause events or the Company’s actual performance or achievements to be materially different than those projected by the Company. For a full discussion of these risks, uncertainties and factors, the Company encourages you to read its documents on file with the SEC. Except as required by law, the Company does not intend to update or revise its forward-looking statements, whether as a result of new information, future events or otherwise.
In accordance with General Instruction B.2. of Form 8-K, the information contained in Item 2.02 and Exhibit 99.1 attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
| Item 9.01 | Financial Statements and Exhibits |
| (d) | Exhibits. |
| 99.1 | Stereotaxis, Inc. Earnings Press Release dated November 9, 2023. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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.
| STEREOTAXIS, INC. | ||
| Date: November 9, 2023 | By: | /s/ Kimberly R. Peery |
| Name: | Kimberly R. Peery | |
| Title: | Chief Financial Officer | |
Exhibit 99.1
Stereotaxis Reports 2023 Third Quarter Financial Results
ST. LOUIS, Nov. 9, 2023 (GLOBE NEWSWIRE) – Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today reported financial results for the third quarter ended September 30, 2023.
“Stereotaxis continues to deliver commercial results and advance a robust innovation strategy, while maintaining financial discipline,” said David Fischel, Chairman and CEO. “Revenue growth in the quarter was driven by continued demand for Genesis with revenue recognition of two robotic systems. System revenue growth counteracted the loss of royalties and residual pressure on procedures. A robust system pipeline along with existing system backlog of $13 million supports continued growth in the coming quarters.”
“We are making broad, methodical progress across the late stages of a comprehensive innovation strategy. Approval to enroll patients in a European clinical study of the MAGiC ablation catheter is expected within weeks. In the US, we determined it reasonable to submit a PMA Supplement for MAGiC and plan to make the regulatory submission prior to year-end. This approach holds the potential to significantly accelerate availability of MAGiC to physicians and patients who would benefit from it. Our collaborations with Abbott and MicroPort, and internal development of a next-generation highly-accessible robot, vascular interventional devices, and a digital surgery solution, continue to make meaningful progress. We remain confident these collectively drive a strategic transformation that makes robotics broadly accessible and impactful across endovascular surgery.”
“Reduced cash utilization reflects continued attention to financial discipline and benefits from the significant build up in inventory in previous quarters. We remain cognizant of the importance of maintaining financial strength and are confident in our ability to realize our innovation strategy with our current resources.”
2023 Third Quarter Financial Results
Revenue for the third quarter of 2023 totaled $7.8 million, compared to $7.7 million in the prior year third quarter. System revenue for the quarter was $3.5 million and recurring revenue was $4.3 million, compared to $2.4 million and $5.3 million in the prior year third quarter, respectively. System revenue growth reflects revenue recognition on the delivery of two Genesis systems. Recurring revenue was impacted by the absence of catheter royalties received in the prior year.
Gross margin for the third quarter of 2023 was 52% of revenue. Recurring revenue gross margin was 80% and system gross margin was 18%. Operating expenses in the third quarter of $9.7 million include $2.6 million in non-cash stock compensation expense. Excluding non-cash stock compensation expense, adjusted operating expenses in the current quarter were $7.1 million compared to $6.9 million in the prior year third quarter.
Operating loss and net loss for the third quarter of 2023 were ($5.6) million and ($5.4) million, respectively, compared to ($5.1) million and ($4.9) million in the previous year. Adjusted operating loss and adjusted net loss for the quarter, excluding non-cash stock compensation expense, were ($3.0) million and ($2.8) million, respectively, compared to ($2.4) million and ($2.2) million in the previous year. Negative free cash flow for the third quarter was ($1.0) million.
Cash Balance and Liquidity
At September 30, 2023, Stereotaxis had cash and cash equivalents, including restricted cash, of $23.0 million and no debt.
Forward Looking Expectations
Stereotaxis expects continued revenue growth in the coming quarters driven by revenue recognition of system backlog and new system orders. Accelerating revenue growth in subsequent years is expected to be supported by new technology launches.
Stereotaxis expects to end the year with $22 million in cash and no debt. This balance sheet allows us to advance a transformative product ecosystem to market, fund its commercialization, and reach profitability without the need for additional financing.
Conference Call and Webcast
Stereotaxis will host a conference call and webcast today, November 9, 2023, at 10:00 a.m. Eastern Time. To access the conference call, dial 1-800-715-9871 (US and Canada) or 1-646-307-1963 (International) and give the participant pass code 3519052. Participants are asked to call 5-10 minutes prior to the start time. To access the live and replay webcast, please visit the investor relations section of the Stereotaxis website at https://ir.stereotaxis.com/.
About Stereotaxis
Stereotaxis (NYSE: STXS) is a pioneer and global leader in innovative surgical robotics for minimally invasive endovascular intervention. Its mission is the discovery, development and delivery of robotic systems, instruments, and information solutions for the interventional laboratory. These innovations help physicians provide unsurpassed patient care with robotic precision and safety, expand access to minimally invasive therapy, and enhance the productivity, connectivity, and intelligence in the operating room. Stereotaxis technology has been used to treat over 100,000 patients across the United States, Europe, Asia, and elsewhere. For more information, please visit www.Stereotaxis.com.
This press release includes statements that may constitute “forward-looking” statements, usually containing the words “believe”, “estimate”, “project”, “expect” or similar expressions. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially. Factors that would cause or contribute to such differences include, but are not limited to, the Company’s ability to manage expenses at sustainable levels, acceptance of the Company’s products in the marketplace, the effect of global economic conditions on the ability and willingness of customers to purchase its technology, competitive factors, changes resulting from healthcare policy, dependence upon third-party vendors, timing of regulatory approvals, the impact of pandemics or other disasters, and other risks discussed in the Company’s periodic and other filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release. There can be no assurance that the Company will recognize revenue related to its purchase orders and other commitments because some of these purchase orders and other commitments are subject to contingencies that are outside of the Company’s control and may be revised, modified, delayed, or canceled.
Company Contacts:
David L. Fischel
Chairman and Chief Executive Officer
Kimberly R. Peery
Chief Financial Officer
314-678-6100
Investors@Stereotaxis.com
STEREOTAXIS, INC.
STATEMENTS OF OPERATIONS
(Unaudited)
| (in thousands, except share and per share amounts) | Three Months Ended September 30, |
Nine Months Ended September 30, |
||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Revenue: | ||||||||||||||||
| Systems | $ | 3,539 | $ | 2,413 | $ | 8,673 | $ | 4,649 | ||||||||
| Disposables, service and accessories | 4,260 | 5,244 | 13,533 | 16,197 | ||||||||||||
| Total revenue | 7,799 | 7,657 | 22,206 | 20,846 | ||||||||||||
| Cost of revenue: | ||||||||||||||||
| Systems | 2,909 | 2,016 | 7,309 | 3,817 | ||||||||||||
| Disposables, service and accessories | 831 | 1,074 | 2,775 | 2,868 | ||||||||||||
| Total cost of revenue | 3,740 | 3,090 | 10,084 | 6,685 | ||||||||||||
| Gross margin | 4,059 | 4,567 | 12,122 | 14,161 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 2,668 | 2,818 | 8,061 | 8,158 | ||||||||||||
| Sales and marketing | 3,097 | 3,111 | 9,585 | 9,337 | ||||||||||||
| General and administrative | 3,933 | 3,690 | 11,011 | 10,986 | ||||||||||||
| Total operating expenses | 9,698 | 9,619 | 28,657 | 28,481 | ||||||||||||
| Operating loss | (5,639 | ) | (5,052 | ) | (16,535 | ) | (14,320 | ) | ||||||||
| Other income | - | - | 27 | - | ||||||||||||
| Interest income, net | 270 | 135 | 835 | 182 | ||||||||||||
| Net loss | $ | (5,369 | ) | $ | (4,917 | ) | $ | (15,673 | ) | $ | (14,138 | ) | ||||
| Cumulative dividend on convertible preferred stock | (338 | ) | (339 | ) | (1,004 | ) | (1,005 | ) | ||||||||
| Net loss attributable to common stockholders | $ | (5,707 | ) | $ | (5,256 | ) | $ | (16,677 | ) | $ | (15,143 | ) | ||||
| Net loss per share attributed to common stockholders: | ||||||||||||||||
| Basic | $ | (0.07 | ) | $ | (0.07 | ) | $ | (0.21 | ) | $ | (0.20 | ) | ||||
| - | ||||||||||||||||
| Diluted | $ | (0.07 | ) | $ | (0.07 | ) | $ | (0.21 | ) | $ | (0.20 | ) | ||||
| Weighted average number of common shares and equivalents: | ||||||||||||||||
| Basic | 82,468,971 | 76,100,007 | 80,028,243 | 75,977,920 | ||||||||||||
| Diluted | 82,468,971 | 76,100,007 | 80,028,243 | 75,977,920 | ||||||||||||
STEREOTAXIS, INC.
BALANCE SHEETS
| September 30, | December 31, | |||||||
| (in thousands, except share amounts) | 2023 | 2022 | ||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 22,100 | $ | 8,586 | ||||
| Restricted cash - current | 525 | 525 | ||||||
| Short-term investments | - | 19,844 | ||||||
| Accounts receivable, net of allowance of $596 and $235 at 2023 and 2022, respectively | 5,246 | 5,090 | ||||||
| Inventories, net | 6,788 | 7,876 | ||||||
| Prepaid expenses and other current assets | 855 | 1,325 | ||||||
| Total current assets | 35,514 | 43,246 | ||||||
| Property and equipment, net | 3,443 | 3,831 | ||||||
| Restricted cash | 350 | 744 | ||||||
| Operating lease right-of-use assets | 5,086 | 5,384 | ||||||
| Prepaid and other non-current assets | 135 | 208 | ||||||
| Total assets | $ | 44,528 | $ | 53,413 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 3,243 | $ | 3,270 | ||||
| Accrued liabilities | 3,160 | 3,306 | ||||||
| Deferred revenue | 6,216 | 7,342 | ||||||
| Current portion of operating lease liabilities | 413 | 373 | ||||||
| Total current liabilities | 13,032 | 14,291 | ||||||
| Long-term deferred revenue | 1,982 | 1,654 | ||||||
| Operating lease liabilities | 5,173 | 5,488 | ||||||
| Other liabilities | 43 | 51 | ||||||
| Total liabilities | 20,230 | 21,484 | ||||||
| Series A - Convertible preferred stock: | ||||||||
| Convertible preferred stock, Series A, par value $0.001; 22,383 shares outstanding at 2023 and 2022 | 5,583 | 5,583 | ||||||
| Stockholders’ equity: | ||||||||
| Convertible preferred stock, Series B, par value $0.001; 10,000,000 shares authorized, 5,610,121 shares outstanding at 2022 | - | 6 | ||||||
| Common stock, par value $0.001; 300,000,000 shares authorized, 80,873,295 and 74,874,459 shares issued at 2023 and 2022, respectively | 81 | 75 | ||||||
| Additional paid-in capital | 551,480 | 543,438 | ||||||
| Treasury stock, 4,015 shares at 2023 and 2022 | (206 | ) | (206 | ) | ||||
| Accumulated deficit | (532,640 | ) | (516,967 | ) | ||||
| Total stockholders’ equity | 18,715 | 26,346 | ||||||
| Total liabilities and stockholders’ equity | $ | 44,528 | $ | 53,413 | ||||