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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
10-Q
(MARK
ONE)
☒ |
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
FOR
THE QUARTERLY PERIOD ENDED MARCH 31, 2024
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 001-36159
STEREOTAXIS,
INC.
(Exact
name of the Registrant as Specified in its Charter)
delaware |
|
94-3120386 |
(State
or Other Jurisdiction of
Incorporation
or Organization) |
|
(I.R.S.
Employer
Identification
Number) |
710
North Tucker Boulevard, Suite 110
St.
Louis, MO 63101
(Address
of Principal Executive Offices including Zip Code)
(314)
678-6100
(Registrant’s
Telephone Number, Including Area Code)
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 |
Securities
registered pursuant to Section 12(g) of the Act: None
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T “See 232.405 of this Chapter” during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files). Yes ☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer”,
“smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer ☐ |
Accelerated
Filer ☐ |
Non-accelerated
filer ☒ |
Smaller
reporting company ☒ |
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. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No ☒
The
number of outstanding shares of the registrant’s common stock on April 30, 2024, was 82,643,243.
STEREOTAXIS,
INC.
INDEX
TO FORM 10-Q
ITEM
1. FINANCIAL STATEMENTS
STEREOTAXIS,
INC.
BALANCE
SHEETS
(in thousands, except share amounts) | |
March 31, 2024 | | |
December 31, 2023 | |
| |
(Unaudited) | | |
| |
Assets | |
| | | |
| | |
Current assets: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 17,633 | | |
$ | 19,818 | |
Restricted cash - current | |
| 525 | | |
| 525 | |
Accounts receivable, net of allowance of $609 and $672 at 2024 and 2023, respectively | |
| 3,953 | | |
| 3,822 | |
Inventories, net | |
| 8,252 | | |
| 8,426 | |
Prepaid expenses and other current assets | |
| 845 | | |
| 676 | |
Total current assets | |
| 31,208 | | |
| 33,267 | |
Property and equipment, net | |
| 3,164 | | |
| 3,304 | |
Restricted cash | |
| 88 | | |
| 219 | |
Operating lease right-of-use assets | |
| 4,876 | | |
| 4,982 | |
Prepaid and other non-current assets | |
| 116 | | |
| 137 | |
Total assets | |
$ | 39,452 | | |
$ | 41,909 | |
| |
| | | |
| | |
Liabilities and stockholders’ equity | |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 3,307 | | |
$ | 3,190 | |
Accrued liabilities | |
| 3,164 | | |
| 2,972 | |
Deferred revenue | |
| 5,938 | | |
| 6,657 | |
Current portion of operating lease liabilities | |
| 443 | | |
| 428 | |
Total current liabilities | |
| 12,852 | | |
| 13,247 | |
Long-term deferred revenue | |
| 1,581 | | |
| 1,637 | |
Operating lease liabilities | |
| 4,945 | | |
| 5,062 | |
Other liabilities | |
| 43 | | |
| 43 | |
Total liabilities | |
| 19,421 | | |
| 19,989 | |
| |
| | | |
| | |
Series A - Convertible preferred stock: | |
| | | |
| | |
Convertible preferred stock, Series A, par value $0.001;
10,000,000 shares authorized, 21,908
and 22,358
shares outstanding at 2024 and 2023 | |
| 5,464 | | |
| 5,577 | |
| |
| | | |
| | |
Stockholders’ equity: | |
| | | |
| | |
Common stock, par value $0.001; 300,000,000 shares authorized, 82,132,777 and 80,949,697 shares issued
at 2024 and 2023, respectively | |
| 82 | | |
| 81 | |
Additional paid in capital | |
| 556,878 | | |
| 554,148 | |
Treasury stock, 4,015 shares at 2024 and 2023 | |
| (206 | ) | |
| (206 | ) |
Accumulated deficit | |
| (542,187 | ) | |
| (537,680 | ) |
Total stockholders’ equity | |
| 14,567 | | |
| 16,343 | |
Total liabilities and stockholders’ equity | |
$ | 39,452 | | |
$ | 41,909 | |
See
accompanying notes.
STEREOTAXIS,
INC.
STATEMENTS
OF OPERATIONS
(Unaudited)
(in thousands, except share and per share amounts) | |
2024 | | |
2023 | |
| |
Three Months Ended March 31, | |
(in thousands, except share and per share amounts) | |
2024 | | |
2023 | |
Revenue: | |
| | | |
| | |
Systems | |
$ | 2,612 | | |
$ | 1,821 | |
Disposables, service and accessories | |
| 4,268 | | |
| 4,727 | |
Total revenue | |
| 6,880 | | |
| 6,548 | |
| |
| | | |
| | |
Cost of revenue: | |
| | | |
| | |
Systems | |
| 1,900 | | |
| 1,697 | |
Disposables, service and accessories | |
| 1,014 | | |
| 975 | |
Total cost of revenue | |
| 2,914 | | |
| 2,672 | |
| |
| | | |
| | |
Gross margin | |
| 3,966 | | |
| 3,876 | |
| |
| | | |
| | |
Operating expenses: | |
| | | |
| | |
Research and development | |
| 2,243 | | |
| 2,746 | |
Sales and marketing | |
| 3,003 | | |
| 3,148 | |
General and administrative | |
| 3,466 | | |
| 3,601 | |
Total operating expenses | |
| 8,712 | | |
| 9,495 | |
Operating loss | |
| (4,746 | ) | |
| (5,619 | ) |
| |
| | | |
| | |
Interest income, net | |
| 239 | | |
| 272 | |
Net loss | |
$ | (4,507 | ) | |
$ | (5,347 | ) |
| |
| | | |
| | |
Cumulative dividend on convertible preferred stock | |
| (331 | ) | |
| (331 | ) |
Net loss attributable to common stockholders | |
$ | (4,838 | ) | |
$ | (5,678 | ) |
| |
| | | |
| | |
Net loss per share attributable to common stockholders: | |
| | | |
| | |
Basic | |
$ | (0.06 | ) | |
$ | (0.07 | ) |
Diluted | |
$ | (0.06 | ) | |
$ | (0.07 | ) |
| |
| | | |
| | |
Weighted average number of common shares and equivalents: | |
| | | |
| | |
Basic | |
| 83,476,498 | | |
| 76,500,965 | |
Diluted | |
| 83,476,498 | | |
| 76,500,965 | |
See
accompanying notes.
STEREOTAXIS,
INC.
STATEMENTS
OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY
(Unaudited)
Three
Months Ended March 31, 2023
| |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| |
(in
thousands, except share amounts) | |
Convertible Preferred
Stock
Series A
(Mezzanine) | | |
Convertible Preferred
Stock
Series B | | |
Common
Stock | | |
Additional
Paid-In
Capital | | |
Treasury
Stock | | |
Accumulated
Deficit | | |
Total
Stockholders’
Equity
(Deficit) | |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Amount | | |
Amount | | |
Amount | | |
Amount | |
Balance
at December 31, 2022 | |
| 22,383 | | |
$ | 5,583 | | |
| 5,610,121 | | |
$ | 6 | | |
| 74,874,459 | | |
$ | 75 | | |
$ | 543,438 | | |
$ | (206 | ) | |
$ | (516,967 | ) | |
$ | 26,346 | |
Stock
issued for the exercise of stock options | |
| | | |
| - | | |
| | | |
| | | |
| 29,188 | | |
| | | |
| 33 | | |
| | | |
| | | |
| 33 | |
Stock-based
compensation | |
| | | |
| | | |
| | | |
| | | |
| 144,054 | | |
| | | |
| 2,655 | | |
| | | |
| | | |
| 2,655 | |
Components
of net loss | |
| | | |
| - | | |
| - | | |
| - | | |
| | | |
| - | | |
| - | | |
| - | | |
| (5,347 | ) | |
| (5,347 | ) |
Employee
stock purchase plan | |
| | | |
| | | |
| | | |
| - | | |
| 11,798 | | |
| | | |
| 23 | | |
| | | |
| | | |
| 23 | |
Balance
at March 31, 2023 | |
| 22,383 | | |
$ | 5,583 | | |
| 5,610,121 | | |
$ | 6 | | |
| 75,059,499 | | |
$ | 75 | | |
$ | 546,149 | | |
$ | (206 | ) | |
$ | (522,314 | ) | |
$ | 23,710 | |
Three
Months Ended March 31, 2024
(in
thousands, except share amounts) | |
Convertible Preferred
Stock
Series A
(Mezzanine) | | |
Convertible Preferred
Stock
Series B | | |
Common
Stock | | |
Additional
Paid-In
Capital | | |
Treasury
Stock | | |
Accumulated
Deficit | | |
Total
Stockholders’
Equity
(Deficit) | |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Amount | | |
Amount | | |
Amount | | |
Amount | |
| |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| |
Balance
at December 31, 2023 | |
| 22,358 | | |
$ | 5,577 | | |
| - | | |
$ | - | | |
| 80,949,697 | | |
$ | 81 | | |
$ | 554,148 | | |
$ | (206 | ) | |
$ | (537,680 | ) | |
$ | 16,343 | |
Balance | |
| 22,358 | | |
$ | 5,577 | | |
| - | | |
$ | - | | |
| 80,949,697 | | |
$ | 81 | | |
$ | 554,148 | | |
$ | (206 | ) | |
$ | (537,680 | ) | |
$ | 16,343 | |
Stock
issued for the exercise of stock options | |
| | | |
| | | |
| | | |
| | | |
| 9,550 | | |
| | | |
| 8 | | |
| | | |
| | | |
| 8 | |
Stock-based
compensation | |
| | | |
| | | |
| | | |
| | | |
| 161,474 | | |
| | | |
| 2,589 | | |
| | | |
| | | |
| 2,589 | |
Components
of net loss | |
| | | |
| - | | |
| | | |
| - | | |
| | | |
| - | | |
| - | | |
| - | | |
| (4,507 | ) | |
| (4,507 | ) |
Employee
stock purchase plan | |
| | | |
| | | |
| | | |
| | | |
| 13,388 | | |
| | | |
| 22 | | |
| | | |
| | | |
| 22 | |
Preferred
stock conversion | |
| (450 | ) | |
| (113 | ) | |
| | | |
| | | |
| 998,668 | | |
| 1 | | |
| 111 | | |
| | | |
| | | |
| 112 | |
Balance
at March 31, 2024 | |
| 21,908 | | |
$ | 5,464 | | |
| - | | |
$ | - | | |
| 82,132,777 | | |
$ | 82 | | |
$ | 556,878 | | |
$ | (206 | ) | |
$ | (542,187 | ) | |
$ | 14,567 | |
Balance | |
| 21,908 | | |
$ | 5,464 | | |
| - | | |
$ | - | | |
| 82,132,777 | | |
$ | 82 | | |
$ | 556,878 | | |
$ | (206 | ) | |
$ | (542,187 | ) | |
$ | 14,567 | |
See
accompanying notes.
STEREOTAXIS,
INC.
STATEMENTS
OF CASH FLOWS
(Unaudited)
(in thousands) | |
2024 | | |
2023 | |
| |
Three Months Ended March 31, | |
(in thousands) | |
2024 | | |
2023 | |
Cash flows from operating activities | |
| | | |
| | |
Net loss | |
$ | (4,507 | ) | |
$ | (5,347 | ) |
Adjustments to reconcile net loss to cash used in operating activities: | |
| | | |
| | |
Depreciation | |
| 140 | | |
| 160 | |
Non-cash lease expense | |
| 3 | | |
| 7 | |
Stock-based compensation | |
| 2,589 | | |
| 2,655 | |
Accretion and short-term investment discount | |
| - | | |
| (197 | ) |
Changes in operating assets and liabilities: | |
| | | |
| | |
Accounts receivable | |
| (131 | ) | |
| 216 | |
Inventories | |
| 174 | | |
| (97 | ) |
Prepaid expenses and other current assets | |
| (169 | ) | |
| (7 | ) |
Other assets | |
| 21 | | |
| 24 | |
Accounts payable | |
| 117 | | |
| 563 | |
Accrued liabilities | |
| 192 | | |
| (1,547 | ) |
Deferred revenue | |
| (775 | ) | |
| 768 | |
Net cash used in operating activities | |
| (2,346 | ) | |
| (2,802 | ) |
Cash flows from investing activities | |
| | | |
| | |
Purchase of property and equipment | |
| - | | |
| (349 | ) |
Net cash used in investing activities | |
| - | | |
| (349 | ) |
Cash flows from financing activities | |
| | | |
| | |
Proceeds from issuance of stock, net of issuance costs | |
| 30 | | |
| 56 | |
Net cash provided by financing activities | |
| 30 | | |
| 56 | |
Net decrease in cash, cash equivalents, and restricted cash | |
| (2,316 | ) | |
| (3,095 | ) |
Cash, cash equivalents, and restricted cash at beginning of period | |
| 20,562 | | |
| 9,855 | |
Cash, cash equivalents, and restricted cash at end of period | |
$ | 18,246 | | |
$ | 6,760 | |
| |
| | | |
| | |
Supplemental disclosure of cash flow information: | |
| | | |
| | |
Purchase of property and equipment included in accounts payable | |
$ | - | | |
$ | 15 | |
| |
| | | |
| | |
Reconciliation of cash, cash equivalents, and restricted cash to balance sheet as of March 31st: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 17,633 | | |
$ | 5,623 | |
Restricted cash - current | |
| 525 | | |
| 525 | |
Restricted cash | |
| 88 | | |
| 612 | |
Total cash, cash equivalents, and restricted cash | |
$ | 18,246 | | |
$ | 6,760 | |
See
accompanying notes.
STEREOTAXIS,
INC.
NOTES
TO FINANCIAL STATEMENTS
(Unaudited)
Notes
to Financial Statements
In
this report, “Stereotaxis”, the “Company”, “Registrant”, “we”, “us”, and
“our” refer to Stereotaxis, Inc. and its wholly owned subsidiaries. Genesis RMN®, Niobe®, Navigant®,
Odyssey®, Odyssey Cinema™, Vdrive®, Vdrive Duo™, V-CAS™,
V-Loop™, V-Sono™, QuikCAS™, Cardiodrive®, and MAGiC ™ are
trademarks of Stereotaxis, Inc. All other trademarks that appear in this report are the property of their respective owners.
1.
Description of Business
Stereotaxis
designs, manufactures and markets robotic systems, instruments and information systems for the interventional laboratory. Our proprietary
robotic technology, Robotic Magnetic Navigation, fundamentally transforms endovascular interventions using precise computer-controlled
magnetic fields to directly control the tip of flexible interventional catheters or devices. Direct control of the tip of an interventional
device, in contrast to all manual hand-held devices that are controlled from their handle, can improve the precision, stability, reach
and safety of these devices during procedures.
Our
primary clinical focus has been electrophysiology, specifically cardiac ablation procedures for the treatment of arrhythmias. Cardiac
ablation has become a well-accepted therapy for arrhythmias and a multi-billion-dollar medical device market with expectations for substantial
long-term growth. Our product strategy is to expand the clinical focus of our technology to several additional
endovascular indications including coronary, neuro, and peripheral interventions.
There
is substantial real-world evidence and clinical literature for Robotic Magnetic Navigation in electrophysiology. Hundreds of electrophysiologists
at over one hundred hospitals globally have treated over 100,000 arrhythmia patients with our robotic technology. Clinical use of our
technology has been documented in over 400 clinical publications. Robotic Magnetic Navigation is designed to enable physicians to complete
more complex interventional procedures with greater success and safety by providing image-guided delivery of catheters through the blood
vessels and chambers of the heart to treatment sites. This is achieved using externally applied computer-controlled magnetic fields that
govern the motion of the working tip of the catheter, resulting in improved navigation. The more flexible atraumatic design of catheters
driven using magnetic fields may reduce the risk of patient harm and other adverse events. Performing the procedure from a control cockpit
enables physicians to complete procedures in a safe location protected from x-ray exposure, with greater ergonomics, and improved efficiency.
We believe these benefits can be applicable in other endovascular indications where navigation through complex vasculature is often challenging
or unsuccessful and generates significant x-ray exposure, and we are investing in research and development in these areas.
Our
primary products include the Genesis RMN System, the Odyssey Solution, and other related devices. Through our strategic
relationships with fluoroscopy system manufacturers, providers of catheters and electrophysiology mapping systems, and other parties,
we offer our customers x-ray systems and other accessory devices.
The
Genesis RMN System is designed to enable physicians to complete more complex interventional procedures by providing image-guided
delivery of catheters through the blood vessels and chambers of the heart to treatment sites. This is achieved using externally applied
magnetic fields that govern the motion of the working tip of the catheter, resulting in improved navigation, efficient procedures, and
reduced x-ray exposure.
The
Odyssey Solution consolidates lab information onto one large integrated display, enabling physicians to view and control all the
key information in the operating room. This is designed to improve lab layout and procedure efficiency. The system also features a remote
viewing and recording capability called Odyssey Cinema, which is an innovative solution that delivers synchronized content for
optimized workflow, advanced care, and improved productivity. This tool includes an archiving capability that allows clinicians to store
and replay entire procedures or segments of procedures. This information can be accessed from locations throughout the hospital local
area network and over the global Odyssey Network providing physicians with a tool for clinical collaboration, remote consultation, and
training.
We
have arrangements with fluoroscopy system manufacturers to provide such systems in a bundled purchase offer for hospitals establishing
robotic interventional operating rooms. These are single-plane, full-power x-ray systems and include the c-arm and powered table. The
combination of RMN Systems with our partnered x-ray systems reduces the cost of acquisition, the ongoing cost of ownership, and the complexity
of installation of a robotic electrophysiology practice.
We
promote our full suite of products in a typical hospital implementation, subject to regulatory approvals or clearances. This implementation
requires a hospital to agree to an upfront capital payment and recurring payments. The upfront capital payment typically includes equipment
and installation charges. The recurring payments typically include disposable costs for each procedure, equipment service costs beyond
the warranty period, and ongoing software updates. In hospitals where our full suite of products has not been implemented, equipment
upgrade or expansion can be implemented upon purchasing of the necessary upgrade or expansion.
We
have received regulatory clearances and approvals necessary for us to market the Genesis RMN System in the U.S. and Europe, and
we are in the process of obtaining necessary registrations for extending our markets in other countries. The Niobe System, our
prior generation robotic magnetic navigation system, the Odyssey Solution, Cardiodrive, e-Contact, and various disposable
interventional devices have received regulatory clearances and approvals in the U.S., Europe, Canada, China, Japan and various other
countries. We have received the regulatory clearances and approvals that allow us to market the Vdrive and Vdrive Duo Systems
with the V-CAS device in the U.S. and Canada. We are pursuing regulatory approvals for the Stereotaxis MAGiC catheter, a robotically-navigated
magnetic ablation catheter designed to perform minimally invasive cardiac ablation procedures, in various global geographies. Approval
processes can be lengthy and uncertain, submissions may require revised or additional non-clinical and clinical data, and regulatory
applications could be denied.
We
have strategic relationships with technology leaders and innovators in the global interventional market. Through these strategic relationships
we provide compatibility between our robotic magnetic navigation system, x-ray systems, and digital imaging and 3D catheter location
sensing technology, as well as disposable interventional devices. The maintenance of these strategic relationships, or the establishment
of equivalent alternatives, is critical to our commercialization efforts. There are no guarantees that any existing strategic relationships
will continue, and efforts are ongoing to ensure the availability of compatible systems and devices and/or equivalent alternatives. We
cannot provide assurance as to the timeline of the ongoing availability of such compatible systems or our ability to obtain equivalent
alternatives on competitive terms or at all.
2.
Summary of Significant Accounting Policies
Basis
of Presentation
The
accompanying unaudited financial statements of Stereotaxis, Inc. have been prepared in accordance with U.S. generally accepted accounting
principles (“GAAP”) for interim financial information and the instructions to Form 10-Q. Accordingly, they do not include
all the disclosures required by GAAP for complete financial statements. In the opinion of management, they include all adjustments, consisting
only of normal recurring adjustments, necessary for a fair presentation of the results for the interim periods presented. Operating results
for the three-month period ended March 31, 2024, are not necessarily indicative of the results that may be expected for the year ending
December 31, 2024, or for future operating periods.
These
interim financial statements and the related notes should be read in conjunction with the annual financial statements and notes included
in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission
(SEC) on March 8, 2024.
Risks
and Uncertainties
Future
results of operations could be materially adversely impacted by macroeconomic and geopolitical factors. The Company continues to experience
difficulties with periodic worldwide supply chain disruptions, including shortages and inflationary pressures, and logistics delays which
make it difficult for us to source parts and ship our products. We have generally been able to conduct normal business activities albeit
in a more deliberate manner than prior to the pandemic, including taking action to increase inventory levels and engaging in discussions
with our vendors on contractual obligations, but we cannot guarantee that they will not be impacted more severely in the future. Our
suppliers and contract manufacturers have experienced, and may continue to experience, similar difficulties. If our manufacturing operations
or supply chains are materially interrupted, it may not be possible for us to timely manufacture or service our products at required
levels, or at all. Changes in economic conditions and supply chain constraints could lead to higher inflation than previously experienced
or expected, which could, in turn, lead to an increase in costs. We may be unable to raise the prices of our products sufficiently to
keep up with the rate of inflation. A material reduction or interruption in any of our manufacturing processes or a substantial increase
in costs would have a material adverse effect on our business, operating results, and financial condition.
Many
of our hospital customers, for whom the purchase of our system involves a significant capital purchase which may be part of a larger
construction project at the customer site (typically the construction of a new building), may themselves be under economic pressures.
Hospitals continue to experience challenges with staffing and cost pressures as supply chain constraints and inflation drive up operating
costs. This may cause delays or cancellations of current purchase orders and other commitments and may exacerbate the long and variable
sales and installation cycles for our robotic magnetic navigation systems. Our hospital customers have also experienced challenges in
sourcing supplies, such as catheters, needed to perform procedures. Such shortages have, and may continue to, put pressure on procedures
and our disposable revenue.
Any
disruption to the capital markets could negatively impact our ability to raise capital. If the capital markets are disrupted for an extended
period of time and we need to raise additional capital, such capital may not be available on acceptable terms, or at all. Disruptions
to the capital markets and other financing sources could also negatively impact our hospital customers’ ability to raise capital
or otherwise obtain financing to fund their operations and capital projects. Such could result in delayed spending on current projects,
a longer sales cycle for new projects where a large capital commitment is required, and decreased demand for our disposable products
as well as an increased risk of customer defaults or delays in payments for our system installations, service contracts and disposable
products.
In
addition to the aforementioned macroeconomic factors, the COVID-19 pandemic negatively affected, and any resurgence of a variant of
COVID-19 or any similar occurrences may in the future negatively affect demand for both our systems and our disposable products. In
the past, we have experienced business disruptions, including travel restrictions on us and our third-party distributors, which
negatively affected our complex sales, marketing, installation, distribution and service network relating to our products and
services. We also experienced reductions in demand for our disposable products as our healthcare customers (physicians and
hospitals) re-prioritized the treatment of patients and diverted resources away from non-coronavirus areas, leading to the
performance of fewer procedures in which our disposable products are used. Significant decreases to our capital or recurring
revenues could have a material adverse effect on our business, operating results, and financial condition. While we cannot reliably
estimate the ultimate duration of the impact or the severity of ongoing periodic resurgences of pandemic-related issues, we continue
to anticipate periodic disruptions to our manufacturing operations, supply chains, procedures volumes, service activities, and
capital system orders and placements, any of which could have a material adverse effect on our business, financial condition,
results of operations, or cash flows. The impact has varied widely over time by individual geography.
Concentration
of Credit Risk
Financial
instruments that potentially subject the Company to concentration of credit risk consist of cash, cash equivalents and marketable securities.
Our investments may include, at any time, a diversified portfolio of cash equivalents and short- and long-term investments in a variety
of high-quality securities, including money market funds, U.S. treasury and U.S. government agency securities, corporate notes and bonds,
commercial paper, non-U.S. government agency securities, and municipal notes. The Company’s exposure to any individual corporate
entity is limited by policy. Deposits may exceed federally insured limits, and the Company is exposed to credit risk on deposits in the
event of default by the financial institutions to the extent account balances exceed the amount insured by the Federal Deposit Insurance
Corporation (FDIC). The Company closely monitors events involving limited liquidity, defaults, non-performance or other adverse developments
that affect financial institutions or other companies in the financial services industry or the financial services industry generally,
including Silicon Valley Bank. On March 10, 2023, Silicon Valley Bank (“SVB”), where the Company maintained accounts with
a cash balance of less than 6% of the Company’s total cash, cash equivalents and marketable securities, was closed by the California
Department of Financial Protection and Innovation and the FDIC was appointed as receiver. On March 12, 2023, the U.S. Department of the
Treasury, Federal Reserve Board, and FDIC released a joint statement announcing that the FDIC would complete its resolution of SVB in
a manner that fully protected all depositors at SVB and that depositors would have access to all of their money starting March 13, 2023.
On March 26, 2023, it was announced that First-Citizens Bank & Trust Company would assume all of SVB’s deposits and loans as
of March 27, 2023. During the periods presented, the Company has not experienced any losses on its deposits of cash, cash equivalents
or marketable securities.
Cash
and Cash Equivalents
Cash
and cash equivalents include cash on hand, money market instruments, and other highly liquid investments with original maturities of
three months or less from the date of purchase. Accrued interest receivable on money market instruments, included in other current assets, was less
than $0.1
million as of March 31, 2024, and December 31,
2023.
Restricted
Cash
Restricted
cash primarily consists of cash that the Company is obligated to maintain in accordance with contractual obligations. The Company’s
restricted cash was $0.6 million and $0.7 million as of March 31, 2024, and December 31, 2023, respectively.
Investments
Our
investments may include, at any time, a diversified portfolio of cash equivalents and short-and long-term investments in a variety of
high-quality securities, including money market funds, U.S. treasury and U.S. government agency securities, corporate notes and bonds,
commercial paper, non-U.S. government agency securities, and municipal notes. As of March 31, 2024, and December 31, 2023, the Company had no short-term investments.
Amortized
cost of U.S. treasury securities and marketable debt securities are based on the Company’s purchase price adjusted for accrual
of discount, or amortization of premium, and recognition of impairment charges, if any. The amortized cost of securities the Company
purchases at a discount or premium will equal the face or par value at maturity or the call date, if applicable. Stated interest on investments
is reported as income when earned and is adjusted for amortization or accretion of any premium or discount.
The
Company segments its portfolio based on the underlying risk profiles of the securities and has a zero-loss expectation for U.S. treasury
and U.S. government agency securities. The Company regularly reviews the securities using the probability of default method and analyzes
the unrealized loss positions and evaluates the current expected credit loss by considering factors such as credit ratings, issuer-specific
factors, current economic conditions, and reasonable and supportable forecasts. The Company did not have any material expected credit
losses on investments or material expected credit losses on accrued interest related to investments during the three months ended March
31, 2024, or year ended December 31, 2023.
Fair
Value Measurements
Financial
instruments consist of cash and cash equivalents, restricted cash, investments, accounts receivable, and accounts payable.
The
Company measures certain financial assets and liabilities at fair value on a recurring basis. General accounting principles for fair
value measurement establishes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value.
The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets and liabilities (“Level
1”) and the lowest priority to unobservable inputs (“Level 3”). The three levels of the fair value hierarchy are described
below:
Level
1: |
|
Values
are based on unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets
or liabilities. |
|
|
|
Level
2: |
|
Values
are based on quoted prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets
that are not active, or other model-based valuation techniques for which all significant assumptions are observable in the market. |
|
|
|
Level
3: |
|
Values
are generated from model-based techniques that use significant assumptions not observable in the market. |
As
of March 31, 2024, and December 31, 2023, financial assets classified as Level 2 consisted of money market funds. The Company reviews
trading activity and pricing for these investments as of the measurement date. When sufficient quoted pricing for identical securities
is not available, the Company uses market pricing and other observable market inputs for similar securities. These inputs either represent
quoted prices for similar assets in active markets or have been derived from observable market data. This approach results in the Level
2 classification of these securities within the fair value hierarchy.
Accounts
Receivable, Contract Assets, and Allowance for Credit Losses
Accounts
receivable primarily include amounts due from hospitals and distributors for acquisition of magnetic systems, associated disposable device
sales and service contracts, net of allowances for expected credit losses. Credit is granted on a limited basis, with balances due generally
within 30 days of billing. Contract assets primarily represent the difference between the revenue that was earned but not billed on service
contracts and revenue from system contracts that was recognized based on the relative selling price of the related performance obligations
and the contractual billing terms in the arrangements. The Company reports accounts receivable and contract
assets net of an allowance for expected credit losses in accordance with Accounting Standards Codification Topic 326, Financial Instruments
– Credit Losses (“ASC 326”). The provision for credit loss
is based upon management’s assessment of historical and expected net collections considering business and economic conditions and
other collection indicators. We assess collectability by reviewing the accounts receivable aging schedule on an aggregated basis where
similar characteristics exist and on an individual basis when we identify specific customers with known disputes or collectability issues.
Amounts deemed uncollectible are recorded as an allowance for expected credit losses.
Revenue
and Costs of Revenue
The
Company accounts for revenue in accordance with Accounting Standards Codification Topic 606 (“ASC 606”), Revenue from
Contracts with Customers.
We
generate revenue from the initial capital sales of systems as well as recurring revenue from the sale of our proprietary disposable devices,
from royalties paid to the Company on the sale of various devices as provided by co-development and co-placement arrangements, and from
other recurring revenue including ongoing software updates and service contracts.
We
account for a contract with a customer when there is a legally enforceable contract between the Company and the customer, the rights
of the parties are identified, the contract has commercial substance, and collectability of the contract consideration is probable. We
record our revenue based on consideration specified in the contract with each customer, net of any taxes collected from customers that
are remitted to government authorities.
For
contracts containing multiple products and services, the Company accounts for individual products and services as separate performance
obligations if they are distinct, which is if a product or service is separately identifiable from other items in the bundled package,
and if a customer can benefit from it on its own or with other resources that are readily available to the customer. The Company recognizes
revenues as the performance obligations are satisfied by transferring control of the product or service to a customer.
For
arrangements with multiple performance obligations, revenue is allocated to each performance obligation based on its relative standalone
selling price. Standalone selling prices are based on observable prices at which the Company separately sells the products or services.
If a standalone selling price is not directly observable, then the Company estimates the standalone selling price considering market
conditions and entity-specific factors including, but not limited to, features and functionality of the products and services and market
conditions. The Company regularly reviews standalone selling prices and updates these estimates if necessary.
Our
revenue recognition policy affects the following revenue streams in our business as follows:
Systems:
Contracts
related to the sale of systems typically contain separate obligations for the delivery of system(s), installation, service-type warranty,
and an implied obligation to provide software enhancements if and when available for one year following installation. Revenue is recognized
when the Company transfers control to the customer, which is generally at the point when acceptance occurs that indicates customer acknowledgment
of delivery or installation, depending on the terms of the arrangement. Revenue from service-type warranties and the implied obligation
to deliver software enhancements if and when available is included in Other Recurring Revenue and is recognized ratably typically over
the first year following installation of the system as the customer receives the service-type warranty and right to software updates
throughout the period. The Company’s system contracts generally do not provide a right of return. Systems are generally covered
by a one-year service-type warranty or a one-year assurance-type warranty. Assurance-type warranty costs were less than $0.1 million
for the three months ended March 31, 2024, and 2023. Revenue from system delivery and installation represented 38% and 28% of revenue
for the three months ended March 31, 2024, and 2023, respectively.
Disposables:
Revenue
from sales of disposable products is recognized when control is transferred to the customers, which generally occurs at the time of shipment,
but can also occur at the time of delivery depending on the customer arrangement. Disposable products are covered by an assurance type
warranty that provides for the return of defective products. Warranty costs were not material for the three months ended March 31, 2024,
and 2023. Disposable revenue represented 21% and 24% of revenue for the three months ended March 31, 2024, and 2023, respectively.
Royalty:
The
Company receives royalties on the sale of various devices as provided by co-development and co-placement arrangements with various manufacturers.
Royalty revenue represented less than 1% of revenue for the three months ended March 31, 2024, and 2023.
Other
Recurring Revenue:
Other
recurring revenue includes revenue from product maintenance plans, service-type warranties, other post warranty maintenance, and the
implied obligation to provide software enhancements if and when available for a specified period, typically one year following installation
of our systems. Revenue from services and software enhancements, service-type warranties, and the implied obligation to provide software
enhancements are deferred and amortized over the service or update period, which is typically one year. Revenue related to services performed
on a time-and-materials basis is recognized when performed. Other recurring revenue represented 41% and 48% of revenue for the three
months ended March 31, 2024, and 2023, respectively.
The
following table summarizes the Company’s revenue for systems, disposables, and service and accessories for the three months ended
March 31, 2024, and 2023 (in thousands):
Schedule of Revenue Disaggregated by Type
| |
2024 | | |
2023 | |
| |
Three Months Ended March 31, | |
| |
2024 | | |
2023 | |
Systems | |
$ | 2,612 | | |
$ | 1,821 | |
Disposables, service and accessories | |
| 4,268 | | |
| 4,727 | |
Total revenue | |
$ | 6,880 | | |
$ | 6,548 | |
Transaction
price allocated to remaining performance obligations relates to amounts allocated to products and services for which the revenue has
not yet been recognized. A significant portion of this amount relates to the Company’s systems contracts and obligations that will
be recognized as revenue in future periods. These obligations are generally satisfied within two years after contract inception but may
occasionally extend longer. Transaction price representing revenue to be earned on remaining performance obligations on system contracts
was approximately $11.9 million as of March 31, 2024. Performance obligations arising from contracts for disposables and service are
generally expected to be satisfied within one year after entering into the contract.
The
following table summarizes the Company’s contract assets and liabilities (in thousands):
Summary of Contract Assets and Liabilities
| |
March 31, 2024 | | |
December 31, 2023 | |
Contract Assets - unbilled receivables | |
$ | 77 | | |
$ | 72 | |
| |
| | | |
| | |
Customer deposits | |
$ | 1,850 | | |
$ | 2,105 | |
Product shipped, revenue deferred | |
| 1,509 | | |
| 1,413 | |
Deferred service and license fees | |
| 4,160 | | |
| 4,776 | |
Total deferred revenue | |
$ | 7,519 | | |
$ | 8,294 | |
Less: Long-term deferred revenue | |
| (1,581 | ) | |
| (1,637 | ) |
Total current deferred revenue | |
$ | 5,938 | | |
$ | 6,657 | |
The
Company invoices its customers based on the billing schedules in its sales arrangements. Contract assets primarily represent the difference
between the revenue that was earned but not billed on service contracts and revenue from system contracts that was recognized based on
the relative selling price of the related performance obligations and the contractual billing terms in the arrangements. Customer deposits
primarily relate to future system sales but can also include deposits on disposable sales. Deferred revenue is primarily related to service
contracts, for which the service fees are billed up-front, generally quarterly or annually, and for amounts billed in advance for system
contracts for which some performance obligations remain outstanding. For service contracts, the associated deferred revenue is generally
recognized ratably over the service period. For system contracts, the associated deferred revenue is recognized when the remaining performance
obligations are satisfied. The Company did not have any impairment losses on its contract assets for the periods presented.
Revenue
recognized for the three months ended March 31, 2024, and 2023, that was included in the deferred revenue balance at the beginning of
each reporting period was $3.0 million.
Assets
Recognized from the Costs to Obtain a Contract with a Customer
The
Company has determined that sales incentive programs for the Company’s sales team meet the requirements to be capitalized as the
Company expects to generate future economic benefits from the related revenue generating contracts after the initial capital sales transaction.
The costs capitalized as contract acquisition costs included in prepaid expenses and other assets, in the Company’s balance sheet
were $0.1 million as of March 31, 2024, and December 31, 2023. The Company did not incur any impairment losses during any of the periods
presented.
Costs
of systems revenue include direct product costs, installation labor and other costs including estimated assurance-type warranty costs,
and initial training costs, when applicable. These costs are recognized at the time of sale. Costs of disposable revenue include direct
product costs and estimated warranty costs and are recognized at the time of sale. Cost of revenue from services and license fees are
recognized when incurred.
Leasing
Arrangements
A
lease is defined as a contract, or part of a contract, that conveys the right to control the use of identified property, plant or equipment
for a period of time in exchange for consideration. The Company accounts for leases in accordance with Accounting Standards Update No.
2016-02 “Leases” (Topic 842) and all subsequent ASUs that modified Topic 842 (“ASC 842”). The Company determines
if an arrangement contains a lease at inception.
The
Company leases its facilities under operating leases. In accordance with ASC 842, operating lease agreements are recognized on the balance
sheet as a right-of-use (“ROU”) asset and a corresponding lease liability. These leases generally do not have significant
rent escalation holidays, concessions, leasehold improvement incentives, or other build-out clauses. Further, the leases do not contain
contingent rent provisions. Many of our leases include both lease (i.e., fixed payments including rent, taxes, and insurance costs) and
non-lease components (i.e., common-area or other maintenance costs) which are accounted for as a single lease component as we have elected
the practical expedient to group lease and non-lease components for all leases.
The
Company’s lease agreements often include one or more options to renew at the Company’s discretion. If at lease inception,
the Company considers the exercising of a renewal option to be reasonably certain, the Company will include the extended term in the
calculation of the ROU asset and lease liability. The Company elected not to include short-term leases (i.e., leases with initial terms
of twelve months or less) on the balance sheet.
The
calculated amounts of the ROU assets and lease liabilities are impacted by the length of the lease term and the discount rate used to
calculate the present value of the minimum lease payments. ASC 842 requires the use of the discount rate implicit in the lease whenever
this rate is readily determinable. As this rate is rarely determinable, the Company utilizes its incremental borrowing rate at lease
inception.
Stock-Based
Compensation
The
Company accounts for its grants of stock options, non-qualified stock options, stock appreciation rights, restricted shares,
restricted stock units and for its employee stock purchase plan in accordance with the provisions of general accounting principles
for share-based payments. These accounting principles require the determination of the fair value of the stock-based compensation at
the grant date and the recognition of the related expense over the period in which the stock-based compensation vests.
For
time-based awards, the Company utilizes the Black-Scholes valuation model to determine the fair value of stock options and stock
appreciation rights at the date of grant. The weighted average assumptions and fair value for options granted during the three
months ended March 31, 2024, were 1) expected dividend rate of 0%;
2) expected volatility of 76%
based on the Company’s historical volatility; 3) risk-free interest rate based on the Treasury yield on the date of grant; and
4) expected term of 6.25
years. The resulting compensation expense is recognized over the requisite service period, which is generally four years. Restricted
shares and units granted to employees and non-employee directors are valued at the fair market value at the date of grant. The
Company amortizes the fair market value to expense over the service period, which is generally four years except for grants to directors which are generally earned over a period of six months. If the shares are subject to performance objectives, the
resulting compensation expense is amortized over the anticipated vesting period and is subject to adjustment based on the actual
achievement of objectives.
For
market-based awards, stock-based compensation expense is recognized over the minimum service period regardless of whether or not the
market target is probable of being achieved. The fair value of such awards is estimated on the grant date using Monte Carlo simulations.
Shares
purchased by employees under the 2022 Employee Stock Purchase Plans are considered to be non-compensatory.
Net
Loss per Common Share
Basic
earnings (loss) per common share is computed by dividing the net earnings (loss) for the period by the weighted average number of common
shares outstanding during the period. In periods where there is net income, we apply the two-class method to calculate basic and diluted
net income (loss) per share of common stock, as our convertible preferred stock is a participating security. The two-class method is
an earnings allocation formula that treats a participating security as having rights to earnings that otherwise would have been available
to common stockholders. In periods where there is a net loss, the two-class method of computing earnings per share does not apply as
our convertible preferred stock does not contractually participate in our losses. We compute diluted net income (loss) per common share
using net income (loss) as the “control number” in determining whether potential common shares are dilutive, after giving
consideration to all potentially dilutive common shares, including stock options, warrants, unvested restricted stock units outstanding
during the period and potential issuance of stock upon the conversion of our convertible preferred stock issued and outstanding during
the period, except where the effect of such securities would be antidilutive.
The
following table sets forth the computation of basic and diluted EPS (in thousands except for share and per share amounts):
Schedule
of Computation of Basic and Diluted Earnings Per Share
| |
2024 | | |
2023 | |
| |
Three Months Ended March 31, | |
| |
2024 | | |
2023 | |
Net loss | |
$ | (4,507 | ) | |
$ | (5,347 | ) |
Cumulative dividend on convertible preferred stock | |
| (331 | ) | |
| (331 | ) |
Net loss attributable to common stockholders | |
$ | (4,838 | ) | |
$ | (5,678 | ) |
| |
| | | |
| | |
Weighted average number of common shares and equivalents: | |
| 83,476,498 | | |
| 76,500,965 | |
Basic EPS | |
$ | (0.06 | ) | |
$ | (0.07 | ) |
Diluted EPS | |
$ | (0.06 | ) | |
$ | (0.07 | ) |
The
Company did not include any portion of unearned restricted shares, outstanding options, stock appreciation rights, warrants or convertible
preferred stock in the calculation of diluted loss per common share because all such securities are anti-dilutive for all periods presented.
The application of the two-class method of computing earnings per share under general accounting principles for participating securities
is not applicable during these periods because those securities do not contractually participate in its losses.
As
of March 31, 2024, the Company had 3,470,733 shares of common stock issuable upon the exercise of outstanding options and stock appreciation
rights at a weighted average exercise price of $3.92 per share, 48,885,547 shares of our common stock issuable upon conversion of our
Series A Convertible Preferred Stock and 1,741,741 shares of unvested restricted share units. The Company had no unearned restricted
shares outstanding as of March 31, 2024.
Recently
Issued Accounting Pronouncements
In
June 2016, the FASB issued ASU 2016-13, “Financial Instruments-Credit Losses (Topic 326), Measurement of Credit Losses on Financial
Instruments” and also issued subsequent amendments to the initial guidance under ASU 2018-19, ASU 2019-04 and ASU 2019-05. The
standard modifies the measurement approach for credit losses on financial instruments, including trade receivables, from an incurred
loss method to a current expected credit loss method, otherwise known as “CECL.” The standard requires the measurement of
expected credit losses to be based on relevant information, including historical experience, current conditions and a forecast that is
supportable. The Company adopted the standard in the first quarter of 2023. The impact to the Company’s financial results was immaterial.
In
December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”),
which requires enhanced income tax disclosures, primarily related to the effective tax rate reconciliation and income taxes paid. The
Company does not expect a significant impact on its income tax disclosures upon adoption of the ASU which will be effective in the Company’s
year ending December 31, 2025.
3.
Financial Instruments
The
following tables summarize the Company’s cash and fair value by significant category reported as cash and cash equivalents and
restricted cash as of March 31, 2024, and December 31, 2023:
Schedule
of Cash and Cash Equivalents, Restricted Cash and Investments
| |
March 31, 2024 | |
| |
Valuation | | |
Reported as: | |
(in thousands) | |
Amortized
Cost | | |
Gross
Unrealized
Gains | | |
Gross
Unrealized
Losses | | |
Fair
Value | | |
Cash and
Cash Equivalents | | |
Restricted
Cash-
current | | |
Short-
term
Investments | | |
Restricted
Cash | |
Cash | |
$ | 1,662 | | |
$ | - | | |
$ | - | | |
$ | 1,662 | | |
$ | 1,662 | | |
$ | - | | |
$ | - | | |
$ | - | |
Level 2 | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Money market funds | |
| 16,584 | | |
| - | | |
| - | | |
| 16,584 | | |
| 15,971 | | |
| 525 | | |
| - | | |
| 88 | |
Subtotal | |
| 16,584 | | |
| - | | |
| - | | |
| 16,584 | | |
| 15,971 | | |
| 525 | | |
| - | | |
| 88 | |
Total assets measured at fair value | |
$ | 18,246 | | |
$ | - | | |
$ | - | | |
$ | 18,246 | | |
$ | 17,633 | | |
$ | 525 | | |
$ | - | | |
$ | 88 | |
| |
December 31, 2023 | |
| |
Valuation | | |
Reported as: | |
(in thousands) | |
Amortized
Cost | | |
Gross
Unrealized
Gains | | |
Gross
Unrealized
Losses | | |
Fair
Value | | |
Cash and
Cash
Equivalents | | |
Restricted
Cash-
current | | |
Short-
term
Investments | | |
Restricted
Cash | |
Cash | |
$ | 2,122 | | |
$ | - | | |
$ | - | | |
$ | 2,122 | | |
$ | 2,122 | | |
$ | - | | |
$ | - | | |
$ | - | |
Level 2 | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Money market funds | |
| 18,440 | | |
| - | | |
| - | | |
| 18,440 | | |
| 17,696 | | |
| 525 | | |
| - | | |
| 219 | |
Subtotal | |
| 18,440 | | |
| - | | |
| - | | |
| 18,440 | | |
| 17,696 | | |
| 525 | | |
| - | | |
| 219 | |
Total assets measured at fair value | |
$ | 20,562 | | |
$ | - | | |
$ | - | | |
$ | 20,562 | | |
$ | 19,818 | | |
$ | 525 | | |
$ | - | | |
$ | 219 | |
Interest
income was approximately $0.2 million and $1.1 million during the three months ended March 31, 2024, and
the year ended December 31, 2023, respectively.
As
of March 31, 2024, and December 31, 2023, the Company did not have any financial assets classified as Level 1 or Level 3 nor did the
Company have financial liabilities valued at fair value on a recurring basis.
4.
Inventories
Inventories
consist of the following (in thousands):
Schedule of Inventories
| |
March 31, 2024 | | |
December 31, 2023 | |
Raw materials | |
$ | 6,507 | | |
$ | 5,918 | |
Work in process | |
| 457 | | |
| 1,034 | |
Finished goods | |
| 3,255 | | |
| 3,413 | |
Reserve for excess and obsolescence | |
| (1,967 | ) | |
| (1,939 | ) |
Total inventory | |
$ | 8,252 | | |
$ | 8,426 | |
The
reserve for excess and obsolescence primarily includes Niobe Systems and related raw materials and spare parts.
5.
Prepaid Expenses and Other Assets
Prepaid
expenses and other assets consist of the following (in thousands):
Schedule of Prepaid Expenses and Other Assets
| |
March 31, 2024 | | |
December 31, 2023 | |
Prepaid expenses | |
$ | 465 | | |
$ | 181 | |
Prepaid commissions | |
| 92 | | |
| 110 | |
Deposits | |
| 284 | | |
| 424 | |
Other assets | |
| 120 | | |
| 98 | |
Total prepaid expenses and other assets | |
| 961 | | |
| 813 | |
Less: Noncurrent prepaid expenses and other assets | |
| (116 | ) | |
| (137 | ) |
Total current prepaid expenses and other assets | |
$ | 845 | | |
$ | 676 | |
6.
Property and Equipment
Property
and Equipment consist of the following (in thousands):
Schedule of Property and Equipment
| |
March 31, 2024 | | |
December 31, 2023 | |
Equipment | |
$ | 4,269 | | |
$ | 4,269 | |
Leasehold improvements | |
| 2,911 | | |
| 2,911 | |
Gross property and equipment | |
| 7,180 | | |
| 7,180 | |
Less: Accumulated depreciation | |
| (4,016 | ) | |
| (3,876 | ) |
Net property and equipment | |
$ | 3,164 | | |
$ | 3,304 | |
The
Company had no additions of property and equipment during the three months ended March 31, 2024, and had less than $0.1 million of property
and equipment additions during the year ended December 31, 2023, associated with the buildout of the new leased space in St. Louis, Missouri.
7.
Leases
On
March 1, 2021, the Company entered into an office lease agreement (the “Lease”) with Globe Building Company (the “Landlord”),
under which the Company leases executive office space and manufacturing facilities of approximately 43,100 square feet of rentable space
located at 710 N. Tucker Boulevard, St. Louis, Missouri (the “Premises”) that serves as the Company’s principal executive
and administrative offices and manufacturing facility. Lease payments commenced on January 1, 2022, and the lease has a term of ten years,
with two renewal options of five years each. The minimum annual rent under the terms of the Lease ranges from approximately $0.8 million
in 2022 to $1.0 million in 2031.
As
of March 31, 2024, the weighted average discount rate for operating leases was 9% and the weighted average remaining lease term for operating
lease term is 7.74 years.
The
following table represents lease costs and other lease information (in thousands):
Schedule of Lease Costs and Other Lease Information
| |
2024 | | |
2023 | |
| |
Three Months Ended March 31, | |
| |
2024 | | |
2023 | |
Operating lease cost | |
$ | 227 | | |
$ | 227 | |
Short-term lease cost | |
| 3 | | |
| 4 | |
Total net lease cost | |
$ | 230 | | |
$ | 231 | |
| |
| | | |
| | |
Cash paid within operating cash flows | |
$ | 258 | | |
$ | 242 | |
Variable
lease costs consist primarily of taxes, insurance, and common area or other maintenance costs for our leased facilities and equipment
which are paid based on actual costs incurred.
Future
minimum payments for operating leases with initial or remaining terms of one year or more as of March 31, 2024, were as follows (in thousands):
Schedule of Future Minimum Operating Lease Payments
| |
March 31, 2024 | |
2024 | |
$ | 674 | |
2025 | |
| 919 | |
2026 | |
| 935 | |
2027 | |
| 956 | |
2028 | |
| 976 | |
2029 and thereafter | |
| 3,054 | |
Total lease payments | |
| 7,514 | |
Less: Interest | |
| (2,126 | ) |
Present value of lease liabilities | |
$ | 5,388 | |
8.
Accrued Liabilities
Accrued
liabilities consist of the following (in thousands):
Schedule of Accrued Liabilities
| |
March 31, 2024 | | |
December 31, 2023 | |
Accrued salaries, bonus, and benefits | |
$ | 1,210 | | |
$ | 1,222 | |
Accrued licenses and maintenance fees | |
| 484 | | |
| 484 | |
Accrued warranties | |
| 90 | | |
| 107 | |
Accrued professional services | |
| 109 | | |
| 138 | |
Accrued investigational sites | |
| 182 | | |
| - | |
Deferred contract obligation | |
| 1,045 | | |
| 1,045 | |
Other | |
| 87 | | |
| 19 | |
Total accrued liabilities | |
| 3,207 | | |
| 3,015 | |
Less: Long term accrued liabilities | |
| (43 | ) | |
| (43 | ) |
Total current accrued liabilities | |
$ | 3,164 | | |
$ | 2,972 | |
9.
Convertible Preferred Stock and Stockholders’ Equity
The
holders of common stock are entitled to one vote for each share held and to receive dividends when and as declared by the Board of Directors
out of funds legally available for dividends, subject to the prior rights or preferences applicable to any preferred stock as may then
be outstanding. No dividends have been declared or paid as of March 31, 2024, and the Company does not presently intend to pay any cash
dividends in the foreseeable future.
Series
A Convertible Preferred Stock and Warrants
In
September 2016, the Company issued (i) 24,000 shares of Series A Convertible Preferred Stock (the “Series A Preferred Stock”),
par value $0.001 per share, with a stated value of $1,000 per share, which are convertible into shares of the Company’s common
stock at an initial conversion rate of $0.65 per share, subject to adjustment for events such as stock splits, combinations and the like
as provided in the certificate of designations covering such Series A Preferred Stock, and (ii) (the SPA Warrants) to purchase an aggregate
of 36,923,078 shares of common stock. The shares of Series A Preferred Stock are entitled to vote on an as-converted basis with the common
stock, subject to specified beneficial ownership issuance limitations. The Series A Preferred Stock bear dividends at a rate of six percent
(6%) per annum, which are cumulative and accrue daily from the date of issuance on the $1,000 stated value. Such dividends will not be
paid in cash except in connection with any liquidation, dissolution or winding up of the Company or any redemption of the Series A Preferred
Stock. Each holder of convertible preferred shares has the right to require us to redeem such holder’s shares of Series A Preferred
Stock upon the occurrence of specified events, which include certain business combinations, the sale of all or substantially all of the
Company’s assets, or the sale of more than 50% of the outstanding shares of the Company’s common stock. In addition, the
Company has the right to redeem the Series A Preferred Stock in the event of a defined change of control. The Series A Preferred Stock
ranks senior to our common stock as to distributions and payments upon the liquidation, dissolution, and winding up of the Company. Since
the Series A Preferred Stock are subject to conditions for redemption that are outside the Company’s control, the Series A Preferred
Stock are presently reported in the mezzanine section of the balance sheet.
2021
CEO Performance Award Unit Grant
On
February 23, 2021, the Company`s Board of Directors, upon recommendation of the Compensation Committee, approved the grant of the CEO
Performance Award to the Company’s Chief Executive Officer. The CEO Performance award is a 10-year performance award of up to 13,000,000
shares, tied to the achievement of market capitalization milestones and subject to minimum service requirements.
As
detailed in the table below, the CEO Performance Award consists of ten vesting tranches. The first market capitalization milestone is
$1.0 billion, and each of the remaining nine market capitalization milestones are in additional $500 million increments, up to $5.5 billion.
Summary of Performance Award And Market Capitalization Milestones
Tranche # | |
No. of Shares Subject to PSU | | |
Market Capitalization Milestones(1) | |
1 | |
| 1,000,000 | | |
$ | 1,000,000,000 | |
2 | |
| 1,500,000 | | |
$ | 1,500,000,000 | |
3 | |
| 1,500,000 | | |
$ | 2,000,000,000 | |
4 | |
| 2,000,000 | | |
$ | 2,500,000,000 | |
5 | |
| 1,000,000 | | |
$ | 3,000,000,000 | |
6 | |
| 1,000,000 | | |
$ | 3,500,000,000 | |
7 | |
| 1,000,000 | | |
$ | 4,000,000,000 | |
8 | |
| 2,000,000 | | |
$ | 4,500,000,000 | |
9 | |
| 1,000,000 | | |
$ | 5,000,000,000 | |
10 | |
| 1,000,000 | | |
$ | 5,500,000,000 | |
Total: | |
| 13,000,000 | | |
| | |
Each
tranche represents a portion of the PSUs covering the number of shares outlined in the table above. Each tranche vests upon (i) satisfaction
of the market capitalization milestones and (ii) continued employment as CEO of the Company from the grant date through December 31,
2030. Absent an earlier termination, the PSUs will expire on December 31, 2030. If our CEO ceases employment as CEO of the Company for
any reason including death, disability, termination for cause or without cause (as defined in the award agreement), or if he voluntary
terminates after service as CEO for at least five years, the remaining service period will be waived and he will retain any PSUs that
have vested through the date of termination.
The
Company received Shareholder approval at its annual meeting on May 20, 2021, for shares to be issued under the award.
The
market capitalization requirement is considered a market condition under FASB Accounting Standards Codification Topic 718 “Compensation
– Stock Compensation” and is estimated on the grant date using Monte Carlo simulations. Recognition of stock-based compensation
expense of all the tranches commenced on February 23, 2021, the date of grant, as the probability of meeting the ten market capitalization
milestones is not considered in determining the timing of expense recognition. The expense will be recognized on an accelerated basis
through 2030. Key assumptions for estimating the performance-based awards fair value at the date of grant included share price on grant
date, volatility of the Company’s common stock price, risk free interest rate, and grant term.
Total
stock-based compensation recorded as operating expense for the CEO Performance Award was $1.8 million for the three months ended March
31, 2024, and 2023. As of March 31, 2024, and 2023, the Company had approximately $35.2 million and $42.4 million, respectively, of total
unrecognized stock-based compensation expense remaining under the CEO Performance Award assuming the grantee’s continued employment
as CEO of the Company, or in a similar capacity, through 2030. As of March 31, 2024, none of the performance milestones established by
the 2021 CEO Incentive Program have been achieved, and no awards have been earned.
Stock
Award Plans
In
February 2022, the Compensation Committee of the Board of Directors adopted the 2022 Stock Incentive Plan (the “Plan”) which
was subsequently approved by the Company’s shareholders. This plan replaced the 2012 Stock Incentive Plan which expired on May
19, 2022. The 2022 Stock Incentive Plan allows for the grant of incentive stock options, non-qualified stock options, stock appreciation
rights, restricted shares and restricted share units to employees, non-employee directors, and third-party consultants.
At
March 31, 2024, the Company had 2,297,196 remaining shares of the Company’s common stock to provide for current and future grants
under its various equity plans.
At
March 31, 2024, the total compensation cost related to options and non-vested stock granted to employees
and non-employees under the Company’s stock award plans but not yet recognized was approximately $3.0 million, excluding compensation
not yet recognized related to the CEO Performance Award discussed above. This cost will be amortized over a period of up to four years
over the underlying estimated service periods and will be adjusted for subsequent changes in actual forfeitures and anticipated vesting
periods.
A
summary of the option and stock appreciation rights activity for the three-month period ended March 31, 2024, is as follows:
Summary of Option and Stock Appreciation Rights Activity
| |
Number of Options/SARs | | |
Range of Exercise Price | | |
Weighted Average Exercise Price per Share | |
Outstanding, December 31, 2023 | |
| 3,650,115 | | |
| $0.74 - $9.87 | | |
$ | 3.93 | |
Granted | |
| 20,000 | | |
| $2.80 | | |
$ | 2.80 | |
Exercised | |
| (9,550 | ) | |
| $0.74 - $2.03 | | |
$ | 0.80 | |
Forfeited | |
| (189,832 | ) | |
| $0.74 - $6.96 | | |
$ | 4.03 | |
Outstanding, March 31, 2024 | |
| 3,470,733 | | |
| $0.74 - $9.87 | | |
$ | 3.92 | |
A
summary of the restricted stock unit activity for the three-month period ended March 31, 2024, is as follows:
Summary of Restricted Stock Unit Activity
| |
Number of Restricted Stock Units | | |
Weighted Average Grant Date Fair Value per Unit | |
Outstanding, December 31, 2023 | |
| 1,502,131 | | |
$ | 3.94 | |
Granted | |
| 389,610 | | |
$ | 1.54 | |
Vested | |
| (150,000 | ) | |
$ | 1.19 | |
Outstanding, March 31, 2024 | |
| 1,741,741 | | |
$ | 3.64 | |
10.
Product Warranty Provisions
The
Company’s standard policy is to warrant all capital systems against defects in material or workmanship for one year following installation.
The Company’s estimate of costs to service the warranty obligations is based on historical experience and current product performance
trends. A regular review of warranty obligations is performed to determine the adequacy of the reserve and adjustments are made to the
estimated warranty liability as appropriate.
Accrued
warranty, which is included in other accrued liabilities, consists of the following (in thousands):
Schedule
of Accrued Warranty
| |
March 31, 2024 | | |
December 31, 2023 | |
Warranty accrual, beginning of the fiscal period | |
$ | 107 | | |
$ | 163 | |
Accrual adjustment for product warranty | |
| (1 | ) | |
| 547 | |
Payments made | |
| (16 | ) | |
| (603 | ) |
Warranty accrual, end of the fiscal period | |
$ | 90 | | |
$ | 107 | |
11.
Commitments and Contingencies
The
Company at times becomes a party to claims in the ordinary course of business. Management believes that the ultimate resolution of
pending or threatened proceedings will not have a material effect on the financial position, results of operations or liquidity of
the Company. In February 2024, a vendor filed financing statements under the Uniform Commercial Code (“UCC”) on
underlying inventory for approximately $0.6
million. We believe the financing statements were filed without merit, and we fully intend on contesting the propriety of such
actions.
In
April 2021, the Company entered into a letter of credit pursuant to the Lease agreement totaling approximately $1.8 million to be delivered
in four equal installments of which the first was delivered in April 2021, the second was delivered in July 2021, the third was delivered
in October 2021, and the fourth was delivered in January 2022. The amount available under this letter of credit automatically reduces
by one fortieth at the end of each month during the lease term.
12.
Subsequent Events
On
May 11, 2024, the Company entered into a definitive share purchase agreement to acquire all of the outstanding equity capital stock of
Access Point Technologies, Inc., a privately-held Minnesota-based developer of innovative electrophysiology catheters, for $3.0 million
of Company common stock at closing and, in addition, Company common stock contingently issuable over five years after closing upon achieving
certain key regulatory and commercial milestones. The acquisition is expected to close by the end of the third quarter of 2024 subject
to customary closing conditions.
ITEM
2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The
following discussion and analysis should be read in conjunction with our financial statements and notes thereto included in this Quarterly
Report on Form 10-Q and in our Annual Report on Form 10-K for the year ended December 31, 2023. Operating results are not necessarily
indicative of results that may occur in future periods.
This
report includes various forward-looking statements that are subject to risks and uncertainties, many of which are beyond our
control. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of
various factors, including those set forth in “Part II - Item 1A. Risk Factors” included in this Quarterly Report on
Form 10-Q and in Part I, Item 1A, “Risk Factors,” included in our Annual Report on Form 10-K for the year ended December
31,2023, as well as various impacts related to our recently announced proposed acquisition of Access Point Technologies, Inc.
(“APT”). Forward-looking statements discuss matters that are not historical facts. Forward-looking statements
include, but are not limited to, discussions regarding our operating strategy, sales and marketing strategy, regulatory strategy,
industry, economic conditions, financial condition, liquidity, capital resources, results of operations, the on-going impact of the
coronavirus (“COVID-19”) pandemic and our response to it or any impact of a similar pandemic, and statements relating to our ability to consummate the APT acquisition
within the expected timing, or at all. Such statements include, but are not limited to, statements
preceded by, followed by, or that otherwise include the words “believe”, “expects”,
“anticipates”, “intends”, “estimates”, “projects”, “can”,
“could”, “may”, “would”, or similar expressions. For those statements, we claim the protection
of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. You should not
unduly rely on these forward-looking statements, which speak only as of the date on which they are made. They give our expectations
regarding the future but are not guarantees. We undertake no obligation to update publicly or revise any forward-looking statements,
whether as a result of new information, future events or otherwise, unless required by law.
Overview
Stereotaxis
designs, manufactures and markets robotic systems, instruments and information systems for the interventional laboratory. Our proprietary
robotic technology, Robotic Magnetic Navigation, fundamentally transforms endovascular interventions using precise computer-controlled
magnetic fields to directly control the tip of flexible interventional catheters or devices. Direct control of the tip of an interventional
device, in contrast to all manual hand-held devices that are controlled from their handle, can improve the precision, stability, reach
and safety of these devices during procedures.
Our
primary clinical focus has been electrophysiology, specifically cardiac ablation procedures for the treatment of arrhythmias. Cardiac
ablation has become a well-accepted therapy for arrhythmias and a multi-billion-dollar medical device market with expectations for substantial
long-term growth. Our product strategy is to expand the clinical focus of our technology to several additional
endovascular indications including coronary, neuro, and peripheral interventions.
There
is substantial real-world evidence and clinical literature for Robotic Magnetic Navigation in electrophysiology. Hundreds of electrophysiologists
at over one hundred hospitals globally have treated over 100,000 arrhythmia patients with our robotic technology. Clinical use of our
technology has been documented in over 400 clinical publications. Robotic Magnetic Navigation is designed to enable physicians to complete
more complex interventional procedures with greater success and safety by providing image-guided delivery of catheters through the blood
vessels and chambers of the heart to treatment sites. This is achieved using externally applied computer-controlled magnetic fields that
govern the motion of the working tip of the catheter, resulting in improved navigation. The more flexible atraumatic design of catheters
driven using magnetic fields may reduce the risk of patient harm and other adverse events. Performing the procedure from a control cockpit
enables physicians to complete procedures in a safe location protected from x-ray exposure, with greater ergonomics, and improved efficiency.
We believe these benefits can be applicable in other endovascular indications where navigation through complex vasculature is often challenging
or unsuccessful and generates significant x-ray exposure, and we are investing in research and development in these areas.
Our
primary products include the Genesis RMN System, the Odyssey Solution, and other related devices. Through our strategic
relationships with fluoroscopy system manufacturers, providers of catheters and electrophysiology mapping systems, and other parties,
we offer our customers magnetically compatible x-ray systems and other accessory devices.
The
Genesis RMN System is designed to enable physicians to complete more complex interventional procedures by providing image-guided
delivery of catheters through the blood vessels and chambers of the heart to treatment sites. This is achieved using externally applied
magnetic fields that govern the motion of the working tip of the catheter, resulting in improved navigation, efficient procedures, and
reduced x-ray exposure.
The
Odyssey Solution consolidates lab information onto one large integrated display, enabling physicians to view and control all the
key information in the operating room. This is designed to improve lab layout and procedure efficiency. The system also features a remote
viewing and recording capability called Odyssey Cinema, which is an innovative solution that delivers synchronized content for
optimized workflow, advanced care, and improved productivity. This tool includes an archiving capability that allows clinicians to store
and replay entire procedures or segments of procedures. This information can be accessed from locations throughout the hospital local
area network and over the global Odyssey Network providing physicians with a tool for clinical collaboration, remote consultation, and
training.
We
have arrangements with fluoroscopy system manufacturers to provide such systems in a bundled purchase offer for hospitals establishing
robotic interventional operating rooms. These are single-plane, full-power x-ray systems and include the c-arm and powered table. The
combination of RMN Systems with our partnered x-ray systems reduces the cost of acquisition, the ongoing cost of ownership, and the complexity
of installation of a robotic electrophysiology practice.
We
promote our full suite of products in a typical hospital implementation, subject to regulatory approvals or clearances. This implementation
requires a hospital to agree to an upfront capital payment and recurring payments. The upfront capital payment typically includes equipment
and installation charges. The recurring payments typically include disposable costs for each procedure, equipment service costs beyond
the warranty period, and ongoing software updates. In hospitals where our full suite of products has not been implemented, equipment
upgrade or expansion can be implemented upon purchasing of the necessary upgrade or expansion.
We
have received regulatory clearances and approvals necessary for us to market the Genesis RMN System in the U.S. and Europe, and
we are in the process of obtaining necessary registrations for extending our markets in other countries. The Niobe System, our
prior generation robotic magnetic navigation system, the Odyssey Solution, Cardiodrive, e-Contact, and various disposable
interventional devices have received regulatory clearances and approvals in the U.S., Europe, Canada, China, Japan and various other
countries. We have received the regulatory clearances and approvals that allow us to market the Vdrive and Vdrive Duo Systems
with the V-CAS device in the U.S. and Canada. We are pursuing regulatory approvals for the Stereotaxis MAGiC catheter, a robotically-navigated
magnetic ablation catheter designed to perform minimally invasive cardiac ablation procedures, in various global geographies. Approval
processes can be lengthy and uncertain, submissions may require revised or additional non-clinical and clinical data, and regulatory
applications could be denied.
We
have strategic relationships with technology leaders and innovators in the global interventional market. Through these strategic relationships
we provide compatibility between our robotic magnetic navigation system, x-ray systems, and digital imaging and 3D catheter location
sensing technology, as well as disposable interventional devices. The maintenance of these strategic relationships, or the establishment
of equivalent alternatives, is critical to our commercialization efforts. There are no guarantees that any existing strategic relationships
will continue, and efforts are ongoing to ensure the availability of compatible systems and devices and/or equivalent alternatives. We
cannot provide assurance as to the timeline of the ongoing availability of such compatible systems or our ability to obtain equivalent
alternatives on competitive terms or at all.
Corporate Developments
On
May 11, 2024, the Company entered into a definitive share purchase agreement to acquire all of the outstanding equity capital stock of
Access Point Technologies, Inc., a privately held Minnesota-based developer of innovative electrophysiology catheters, for $3.0 million
of Company common stock at closing and, in addition, Company common stock contingently issuable over five years after closing upon achieving
certain key regulatory and commercial milestones. The acquisition is expected to close by the end of the third quarter of 2024 subject
to customary closing conditions.
Risks
and Uncertainties
Future
results of operations could be materially adversely impacted by macroeconomic and geopolitical factors. The Company continues to experience
difficulties with periodic worldwide supply chain disruptions, including shortages and inflationary pressures, and logistics delays which
make it difficult for us to source parts and ship our products. We have generally been able to conduct normal business activities albeit
in a more deliberate manner than prior to the pandemic, including taking action to increase inventory levels and engaging in discussions
with our vendors on contractual obligations, but we cannot guarantee that they will not be impacted more severely in the future. Our
suppliers and contract manufacturers have experienced, and may continue to experience, similar difficulties. If our manufacturing operations
or supply chains are materially interrupted, it may not be possible for us to timely manufacture or service our products at required
levels, or at all. Changes in economic conditions and supply chain constraints could lead to higher inflation than previously experienced
or expected, which could, in turn, lead to an increase in costs. We may be unable to raise the prices of our products sufficiently to
keep up with the rate of inflation. A material reduction or interruption in any of our manufacturing processes or a substantial increase
in costs would have a material adverse effect on our business, operating results, and financial condition.
Many
of our hospital customers, for whom the purchase of our system involves a significant capital purchase which may be part of a larger
construction project at the customer site (typically the construction of a new building), may themselves be under economic pressures.
Hospitals continue to experience challenges with staffing and cost pressures as supply chain constraints and inflation drive up operating
costs. This may cause delays or cancellations of current purchase orders and other commitments and may exacerbate the long and variable
sales and installation cycles for our robotic magnetic navigation systems. Our hospital customers have also experienced challenges in
sourcing supplies, such as catheters, needed to perform procedures. Such shortages have, and may continue to, put pressure on procedures
and our disposable revenue.
Any
disruption to the capital markets could negatively impact our ability to raise capital. If the capital markets are disrupted for an extended
period of time and we need to raise additional capital, such capital may not be available on acceptable terms, or at all. Disruptions
to the capital markets and other financing sources could also negatively impact our hospital customers’ ability to raise capital
or otherwise obtain financing to fund their operations and capital projects. Such could result in delayed spending on current projects,
a longer sales cycle for new projects where a large capital commitment is required, and decreased demand for our disposable products
as well as an increased risk of customer defaults or delays in payments for our system installations, service contracts and disposable
products.
In
addition to the aforementioned macroeconomic factors, the COVID-19 pandemic negatively affected, and any resurgence of a variant of
COVID-19 or any similar occurrences may in the future negatively affect demand for both our systems and our disposable products. In
the past, we have experienced business disruptions, including travel restrictions on us and our third-party distributors, which
negatively affected our complex sales, marketing, installation, distribution and service network relating to our products and
services. We also experienced reductions in demand for our disposable products as our healthcare customers (physicians and
hospitals) re-prioritized the treatment of patients and diverted resources away from non-coronavirus areas, leading to the
performance of fewer procedures in which our disposable products are used. Significant decreases to our capital or recurring
revenues could have a material adverse effect on our business, operating results, and financial condition. While we cannot reliably
estimate the ultimate duration of the impact or the severity of ongoing periodic resurgences of pandemic-related issues, we continue
to anticipate periodic disruptions to our manufacturing operations, supply chains, procedures volumes, service activities, and
capital system orders and placements, any of which could have a material adverse effect on our business, financial condition,
results of operations, or cash flows. The impact has varied widely over time by individual geography.
Concentration
of Credit Risk
Financial
instruments that potentially subject the Company to concentration of credit risk consist of cash, cash equivalents and marketable securities.
Our investments may include, at any time, a diversified portfolio of cash equivalents and short- and long-term investments in a variety
of high-quality securities, including money market funds, U.S. treasury and U.S. government agency securities, corporate notes and bonds,
commercial paper, non-U.S. government agency securities, and municipal notes. The Company’s exposure to any individual corporate
entity is limited by policy. Deposits may exceed federally insured limits, and the Company is exposed to credit risk on deposits in the
event of default by the financial institutions to the extent account balances exceed the amount insured by the Federal Deposit Insurance
Corporation (FDIC). The Company closely monitors events involving limited liquidity, defaults, non-performance or other adverse developments
that affect financial institutions or other companies in the financial services industry or the financial services industry generally,
including Silicon Valley Bank. On March 10, 2023, Silicon Valley Bank (“SVB”), where the Company maintained accounts with
a cash balance of less than 6% of the Company’s total cash, cash equivalents and marketable securities, was closed by the California
Department of Financial Protection and Innovation and the FDIC was appointed as receiver. On March 12, 2023, the U.S. Department of the
Treasury, Federal Reserve Board, and FDIC released a joint statement announcing that the FDIC would complete its resolution of SVB in
a manner that fully protected all depositors at SVB and that depositors would have access to all of their money starting March 13, 2023.
On March 26, 2023, it was announced that First-Citizens Bank & Trust Company would assume all of SVB’s deposits and loans as
of March 27, 2023. During the periods presented, the Company has not experienced any losses on its deposits of cash, cash equivalents
or marketable securities.
Critical
Accounting Policies and Estimates
Our
discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared
in accordance with U.S. generally accepted accounting principles. The preparation of these financial statements requires us to make estimates
and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosures. We review our
estimates and judgments on an on-going basis. We base our estimates and judgments on historical experience and on various other assumptions
that we believe to be reasonable under the circumstances. Actual results may differ from these estimates. We believe the following accounting
policies are critical to the judgments and estimates we use in preparing our financial statements. For a complete listing of our critical
accounting policies, please refer to our Annual Report on Form 10-K for the year ended December 31, 2023.
Revenue
Recognition
We
generate revenue from the initial capital sales of systems as well as recurring revenue from the sale of our proprietary disposable devices,
from royalties paid to the Company on the sale of various devices as provided by co-development and co-placement arrangements, and from
other recurring revenue including ongoing software updates and service contracts.
In
accordance with Accounting Standards Codification Topic 606 (“ASC 606”), “Revenue from Contracts with Customers,”
we account for a contract with a customer when there is a legally enforceable contract between the Company and the customer, the rights
of the parties are identified, the contract has commercial substance, and collectability of the contract consideration is probable. We
record our revenue based on consideration specified in the contract with each customer, net of any taxes collected from customers that
are remitted to government authorities.
For
contracts containing multiple products and services the Company accounts for individual products and services as separate performance
obligations if they are distinct, which is if a product or service is separately identifiable from other items in the bundled package,
and if a customer can benefit from it on its own or with other resources that are readily available to the customer. The Company recognizes
revenues as the performance obligations are satisfied by transferring control of the product or service to a customer.
For
arrangements with multiple performance obligations, revenue is allocated to each performance obligation based on its relative standalone
selling price. Standalone selling prices are based on observable prices at which the Company separately sells the products or services.
If a standalone selling price is not directly observable, then the Company estimates the standalone selling price considering market
conditions and entity-specific factors including, but not limited to, features and functionality of the products and services and market
conditions. The Company regularly reviews standalone selling prices and updates these estimates as necessary.
Systems:
Contracts
related to the sale of systems typically contain separate obligations for the delivery of system(s), installation, service-type warranty,
and an implied obligation to provide software enhancements if and when available for one year following installation. Revenue is recognized
when the Company transfers control to the customer, which is generally at the point when acceptance occurs that indicates customer acknowledgment
of delivery or installation, depending on the terms of the arrangement. Revenue from service-type warranties and the implied obligation
to deliver software enhancements if and when available is included in Other Recurring Revenue and is recognized ratably typically over
the first year following installation of the system as the customer receives the service-type warranty and right to software updates
throughout the period. The Company’s system contracts generally do not provide a right of return. Systems are generally covered
by a one-year service-type warranty or a one-year assurance-type warranty. Assurance-type warranty costs were less than $0.1 million
for the three months ended March 31, 2024, and 2023.
Disposables:
Revenue
from sales of disposable products is recognized when control is transferred to the customers, which generally occurs at the time of shipment,
but can also occur at the time of delivery depending on the customer arrangement. Disposable products are covered by an assurance type
warranty that provides for the return of defective products. Warranty costs were not material for the three months ended March 31, 2024,
and 2023.
Royalty:
The
Company receives royalties on the sale of various devices as provided by co-development and co-placement arrangements with various manufacturers.
Other
Recurring Revenue:
Other
recurring revenue includes revenue from product maintenance plans, service-type warranties, other post warranty maintenance, and the
implied obligation to provide software enhancements if and when available for a specified period, typically one year following installation
of our systems. Revenue from services and software enhancements, service-type warranties, and the implied obligation to provide software
enhancements are deferred and amortized over the service or update period, which is typically one year. Revenue related to services performed
on a time-and-materials basis is recognized when performed.
The
Company invoices its customers based on the billing schedules in its sales arrangements. Contract assets primarily represent the difference
between the revenue that was recognized based on the relative selling price of the related performance obligations and the contractual
billing terms in the arrangements. Customer deposits primarily relate to future system sales but can also include deposits on disposable
sales. Deferred revenue is primarily related to service contracts, for which the service fees are billed up-front, generally quarterly
or annually, and for amounts billed in advance for system contracts for which some performance obligations remain outstanding. For service
contracts, the associated deferred revenue is generally recognized ratably over the service period. For system contracts, the associated
deferred revenue is recognized when the remaining performance obligations are satisfied. See Note 2 for additional detail on deferred
revenue. The Company did not have any impairment losses on its contract assets for the periods presented.
Assets
Recognized from the Costs to Obtain a Contract with a Customer
The
Company has determined that sales incentive programs for the Company’s sales team meet the requirements to be capitalized as the
Company expects to generate future economic benefits from the related revenue generating contracts after the initial capital sales transaction.
The costs capitalized as contract acquisition costs included in prepaid expenses and other assets in the Company’s balance sheets
were $0.1 million as of March 31, 2024, and December 31, 2023. The Company did not incur any impairment losses during any of the periods
presented.
Cost
of Contracts
Costs
of systems revenue include direct product costs, installation labor and other costs including estimated assurance-type warranty costs
and initial training costs, when applicable. These costs are recognized at the time of sale. Costs of disposable revenue include direct
product costs and estimated warranty costs and are recognized at the time of sale. Cost of revenue from services and license fees are
recognized when incurred.
Stock-Based
Compensation
Stock
compensation expense, which is a non-cash charge, results from stock option, non-qualified stock options, stock appreciation rights,
and restricted share grants made to employees, non-employee directors, and third-party consultants at the fair value of the grants.
For time-based awards, the fair value of options and stock appreciation rights granted was determined using the Black-Scholes
valuation method which gives consideration to the estimated value of the underlying stock at the date of grant, the exercise price
of the option, the expected dividend yield and volatility of the underlying stock, the expected life of the option and the
corresponding risk-free interest rate. The fair value of the grants of restricted shares and units was determined based on the
closing price of our stock on the date of grant. Stock compensation expense for options, stock appreciation rights and for
time-based restricted share grants and units is amortized on a straight-line basis over the vesting period of the underlying issue,
generally over four years except for grants to non-employee directors which are generally earned over a period of six months. Stock
compensation expense for performance-based restricted shares, if any, is amortized on a straight-line basis over the anticipated
vesting period and is subject to adjustment based on the actual achievement of objectives. Compensation expense is recognized only
for those options expected to vest, net of actual forfeitures. Estimates of the expected life of options have been based on the
average of the vesting and expiration periods, which is the simplified method under general accounting principles for share-based
payments. Estimates of volatility utilized in calculating stock-based compensation have been prepared based on historical data.
Actual experience to date has been consistent with these estimates.
For
market-based awards, stock-based compensation expense is recognized over the minimum service period regardless of whether or not the
market target is probable of being achieved. The fair value of such awards is estimated on the grant date using Monte Carlo simulations.
The
amount of compensation expense to be recorded in future periods may increase if we make additional grants of options, stock appreciation
rights or restricted shares. The amount of expense to be recorded in future periods may decrease if the requisite service periods are
not completed.
Results
of Operations
Comparison
of the Three Months Ended March 31, 2024, and 2023
Revenue.
Revenue increased from $6.5 million for the three months ended March 31, 2023, to $6.9 million for the three months ended March 31,
2024, an increase of 5%. Revenue from the sales of systems increased to $2.6 million for the three months ended March 31, 2024, from
$1.8 million for the three months ended March 31, 2023, driven by increased system sales volumes and changes in product mix in the
current year period. Revenue from sales of disposable interventional devices, service, and accessories decreased to approximately
$4.3 million for the three months ended March 31, 2024, from $4.7 million for the three months ended March 31, 2023, a decrease of
approximately 10%. The decrease was primarily driven by lower service revenue from time and material contracts in addition to lower
current period disposable sales volumes related to Biosense Webster catheter shortages.
Cost
of Revenue. Cost of revenue increased from $2.7 million for the three months ended March 31, 2023, to $2.9 million for the three
months ended March 31, 2024, an increase of approximately 9%. As a percentage of our total revenue, overall gross margin remained fairly
consistent at 58% for the three months ended March 31, 2024, compared to 59% for the three months ended March 31, 2023. Cost of revenue
for systems sold increased to $1.9 million for the three months ended March 31, 2024, from $1.7 million for the three months ended March
31, 2023, driven by increased system sales volumes and changes in product mix in the current year period. Gross margin for systems was
$0.7 million for the three months ended March 31, 2024, compared to $0.1 million for the three months ended March 31, 2023. Cost of revenue
for disposables, service, and accessories remained consistent at $1.0 million for the three months ended March 31, 2023, and 2024. Gross
margin for disposables, service, and accessories was 76% for the three months ended March 31, 2024, compared to 79% for the three months
ended March 31, 2023.
Research
and Development Expenses. Research and development expenses decreased from $2.7 million for the three months ended March 31, 2023,
to $2.2 million for the three months ended March 31, 2024, a decrease of approximately 18%. This decrease was primarily driven by project
timing and decreased headcount-related costs in the current year period, partially offset by higher clinical trial costs.
Sales
and Marketing Expenses. Sales and marketing expenses decreased from $3.1 million for the three months ended March 31, 2023, to $3.0
million for the three months ended March 31, 2024, a decrease of approximately 5% primarily due to decreased headcount-related costs
in the current year period.
General
and Administrative Expenses. General and administrative expenses include finance, information systems, legal, and general management.
General and administrative expenses decreased from $3.6 million for the three months ended March 31, 2023, to $3.5 million for the three
months ended March 31, 2024, a decrease of approximately 4%. This decrease was driven by lower administrative and headcount-related costs
in the current period.
Interest
Income (Expense). Net interest income was approximately $0.2 million for the three months ended March 31, 2024, compared to approximately
$0.3 million for the three months ended March 31, 2023. The decrease was driven by lower invested balances in the current year period.
Liquidity
and Capital Resources
Liquidity
refers to the liquid financial assets available to fund our business operations and pay for near-term obligations. These liquid financial
assets consist of cash, cash equivalents, and investments.
As
of March 31, 2024, we had $18.2 million of cash and cash equivalents, inclusive of restricted cash. We had working capital of $18.4 million
as of March 31, 2024, compared to $20.0 million as of December 31, 2023.
The
following table summarizes our cash flow by operating, investing and financing activities for the three months ended March 31, 2024,
and 2023 (in thousands):
| |
Three Months Ended March 31, | |
| |
2024 | | |
2023 | |
Cash flow used in operating activities | |
$ | (2,346 | ) | |
$ | (2,802 | ) |
Cash flow used in investing activities | |
| - | | |
| (349 | ) |
Cash flow provided by financing activities | |
| 30 | | |
| 56 | |
Net
cash used in operating activities. We used approximately $2.3 million and $2.8 million of cash for operating activities during the
three months ended March 31, 2024, and 2023, respectively. The decrease in cash used in operating activities was driven by the decrease
in operating loss in the current year period partially offset by changes in working capital.
Net
cash used in investing activities. We did not use any cash for investing activities during the three months ended March 31, 2024.
We used approximately $0.3 million during the three months ended March 31, 2023, for the purchase of equipment, construction and design
costs associated with our new facility.
Net
cash provided by financing activities. We generated less than $0.1 million of cash from financing activities during the three months
ended March 31, 2024, and 2023. The cash generated in both periods was driven by the proceeds from issuance of stock from the exercise
of options, net of issuance costs, and from our employee stock purchase program.
Capital
Resources
As
of March 31, 2024, the Company did not have any debt.
Off-Balance
Sheet Arrangements
We
do not currently have, nor have we ever had, any relationships with unconsolidated entities or financial partnerships, such as entities
often referred to as structured finance or special purpose entities, which would have been established for the purpose of facilitating
off-balance sheet arrangements or other contractually narrow or limited purposes. In addition, we do not engage in trading activities
involving non-exchange traded contracts. As a result, we are not materially exposed to any financing, liquidity, market, or credit risk
that could have arisen if we had engaged in these relationships.
ITEM
3. [RESERVED]
None.
ITEM
4. CONTROLS AND PROCEDURES
Disclosure
Controls and Procedures: The Company’s management, with the participation of the Company’s Chief Executive Officer and
Chief Financial Officer, has evaluated the effectiveness of the Company’s disclosure controls and procedures (as such term is defined
in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)), as of the end
of the period covered by this report. Any controls and procedures, no matter how well designed and operated, can provide only reasonable
assurance of achieving the desired control objectives, and management is required to apply its judgment in evaluating the cost-benefit
relationship of possible controls and procedures. Based on such evaluation, the Company’s Chief Executive Officer and Chief Financial
Officer have concluded that, as of the end of such period, the Company’s disclosure controls and procedures were effective.
Changes
In Internal Control Over Financial Reporting: The Company’s management, with the participation of the Company’s Chief
Executive Officer and Chief Financial Officer, also conducted an evaluation of the Company’s internal control over financial reporting
to determine whether any changes occurred during the period covered by this report that have materially affected, or are reasonably likely
to materially affect, the Company’s internal control over financial reporting. Based on that evaluation, there has been no such
change during the period covered by this report.
PART
II – OTHER INFORMATION
ITEM
1. LEGAL PROCEEDINGS
None.
ITEM
1A. RISK FACTORS
None.
ITEM
2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
None.
ITEM
3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM
4. [RESERVED]
None.
ITEM
5. OTHER INFORMATION
None.
ITEM
6. EXHIBITS
Number |
|
Description |
|
|
|
3.1 |
|
Restated Articles of Incorporation of the Registrant, incorporated by reference to Exhibit 3.1 of the Registrant’s Form 10-Q (File No. 000-50884) for the fiscal quarter ended September 30, 2004. |
|
|
|
3.2 |
|
Certificate of Amendment to Amended and Restated Certificate of Incorporation, incorporated by reference to Exhibit 3.1 of the Registrant’s Form 8-K (File No. 000-50884) filed on July 10, 2012. |
|
|
|
3.3 |
|
Certificate of Designations, Preferences and Rights of Series A Convertible Preferred Stock, incorporated by reference to Exhibit 3.1 of the Registrant’s Current Report on Form 8-K (File No. 001-36159) filed on September 30, 2016. |
|
|
|
3.4 |
|
Restated Bylaws of the Registrant, incorporated by reference to Exhibit 3.2 of the Registrant’s Form 10-Q (File No. 000-50884) for the fiscal quarter ended September 30, 2004. |
|
|
|
31.1 |
|
Rule 13a-14(a)/15d-14(a) Certification (pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, executed by Chief Executive Officer). |
|
|
|
31.2 |
|
Rule 13a-14(a)/15d-14(a) Certification (pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, executed by Chief Financial Officer). |
|
|
|
32.1 |
|
Section 1350 Certification (pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, executed by Chief Executive Officer). |
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32.2 |
|
Section 1350 Certification (pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, executed by Chief Financial Officer). |
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101.INS |
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Inline
XBRL Instance Document. |
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101.SCH |
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Inline
XBRL Taxonomy Extension Schema Document. |
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101.CAL |
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Inline
XBRL Taxonomy Extension Calculation Linkbase Document. |
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101.DEF |
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Inline
XBRL Taxonomy Extension Definition Linkbase Document. |
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101.LAB |
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Inline
XBRL Taxonomy Extension Label Linkbase Document. |
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101.PRE |
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Inline
XBRL Taxonomy Extension Presentation Linkbase Document. |
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104 |
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Cover
Page Interactive Data File (embedded within the Inline XBRL document) |
STEREOTAXIS,
INC.
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 thereunto duly authorized.
|
STEREOTAXIS,
INC. (Registrant) |
|
|
|
Date:
May 15, 2024 |
By: |
/s/
David L. Fischel |
|
|
David
L. Fischel |
|
|
Chief
Executive Officer |
|
|
|
Date:
May 15, 2024 |
By: |
/s/
Kimberly R. Peery |
|
|
Kimberly
R. Peery |
|
|
Chief
Financial Officer |
Exhibit
31.1
Certification
of Principal Executive Officer
I,
David L. Fischel, certify that:
1. |
I
have reviewed this quarterly report on Form 10-Q of Stereotaxis, Inc.; |
|
|
2. |
Based
on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to
the period covered by this report; |
|
|
3. |
Based
on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in
this report; |
|
|
4. |
The
registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange
Act Rules 13a – 15(f) and 15d – 15(f)) for the registrant and have: |
(a)
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared;
(b)
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under
our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles;
(c)
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions
about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and
(d)
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal
control over financial reporting; and
5. |
The
registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial
reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing
the equivalent functions): |
(a)
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and
(b)
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting.
Date:
May 15, 2024 |
/s/
David L. Fischel |
|
David
L. Fischel |
|
Chief
Executive Officer |
|
Stereotaxis,
Inc. |
|
(Principal
Executive Officer) |
Exhibit
31.2
Certification
of Principal Financial Officer
I,
Kimberly R. Peery, certify that:
1. |
I
have reviewed this quarterly report on Form 10-Q of Stereotaxis, Inc.; |
|
|
2. |
Based
on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to
the period covered by this report; |
|
|
3. |
Based
on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in
this report; |
|
|
4. |
The
registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange
Act Rules 13a – 15(f) and 15d – 15(f)) for the registrant and have: |
(a)
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared;
(b)
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under
our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles;
(c)
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions
about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and
(d)
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal
control over financial reporting; and
5. |
The
registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial
reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing
the equivalent functions): |
(a)
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and
(b)
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting.
Date:
May 15, 2024 |
/s/
Kimberly R. Peery |
|
Kimberly
R. Peery |
|
Chief
Financial Officer |
|
Stereotaxis,
Inc. |
|
(Principal
Financial Officer) |
Exhibit
32.1
CERTIFICATION
PURSUANT TO 18 U.S.C. SECTION 1350,
AS
ADOPTED PURSUANT TO
SECTION
906 OF THE SARBANES-OXLEY ACT OF 2002
In
connection with the quarterly report of Stereotaxis, Inc. (the “Company”) on Form 10-Q for the period ended March 31, 2024
as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, David L. Fischel, Chief Executive
Officer of the Company, certify, pursuant to Rule 13a-14(b) and Section 1350 of Chapter 63 of Title 18 of the United States Code, as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to the best of my knowledge:
(1)
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2)
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations
of the Company.
Date:
May 15, 2024 |
/s/
David L. Fischel |
|
David
L. Fischel |
|
Chief
Executive Officer |
|
Stereotaxis,
Inc. |
Exhibit
32.2
CERTIFICATION
PURSUANT TO 18 U.S.C. SECTION 1350,
AS
ADOPTED PURSUANT TO
SECTION
906 OF THE SARBANES-OXLEY ACT OF 2002
In
connection with the quarterly report of Stereotaxis, Inc. (the “Company”) on Form 10-Q for the period ended March 31, 2024
as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Kimberly R. Peery, Chief Financial
Officer of the Company, certify, pursuant to Rule 13a-14(b) and Section 1350 of Chapter 63 of Title 18 of the United States Code, as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to the best of my knowledge:
(1)
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2)
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations
of the Company.
Date:
May 15, 2024 |
/s/
Kimberly R. Peery |
|
Kimberly
R. Peery |
|
Chief
Financial Officer |
|
Stereotaxis,
Inc. |
v3.24.1.1.u2
Cover - shares
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3 Months Ended |
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Mar. 31, 2024 |
Apr. 30, 2024 |
Cover [Abstract] |
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STEREOTAXIS,
INC.
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v3.24.1.1.u2
Balance Sheets - USD ($) $ in Thousands |
Mar. 31, 2024 |
Dec. 31, 2023 |
Current assets: |
|
|
Cash and cash equivalents |
$ 17,633
|
$ 19,818
|
Restricted cash - current |
525
|
525
|
Accounts receivable, net of allowance of $609 and $672 at 2024 and 2023, respectively |
3,953
|
3,822
|
Inventories, net |
8,252
|
8,426
|
Prepaid expenses and other current assets |
845
|
676
|
Total current assets |
31,208
|
33,267
|
Property and equipment, net |
3,164
|
3,304
|
Restricted cash |
88
|
219
|
Operating lease right-of-use assets |
4,876
|
4,982
|
Prepaid and other non-current assets |
116
|
137
|
Total assets |
39,452
|
41,909
|
Current liabilities: |
|
|
Accounts payable |
3,307
|
3,190
|
Accrued liabilities |
3,164
|
2,972
|
Deferred revenue |
5,938
|
6,657
|
Current portion of operating lease liabilities |
443
|
428
|
Total current liabilities |
12,852
|
13,247
|
Long-term deferred revenue |
1,581
|
1,637
|
Operating lease liabilities |
4,945
|
5,062
|
Other liabilities |
43
|
43
|
Total liabilities |
19,421
|
19,989
|
Series A - Convertible preferred stock: |
|
|
Convertible preferred stock, Series A, par value $0.001; 10,000,000 shares authorized, 21,908 and 22,358 shares outstanding at 2024 and 2023 |
5,464
|
5,577
|
Stockholders’ equity: |
|
|
Common stock, par value $0.001; 300,000,000 shares authorized, 82,132,777 and 80,949,697 shares issued at 2024 and 2023, respectively |
82
|
81
|
Additional paid in capital |
556,878
|
554,148
|
Treasury stock, 4,015 shares at 2024 and 2023 |
(206)
|
(206)
|
Accumulated deficit |
(542,187)
|
(537,680)
|
Total stockholders’ equity |
14,567
|
16,343
|
Total liabilities and stockholders’ equity |
$ 39,452
|
$ 41,909
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v3.24.1.1.u2
Balance Sheets (Parenthetical) - USD ($) $ in Thousands |
Mar. 31, 2024 |
Dec. 31, 2023 |
Statement of Financial Position [Abstract] |
|
|
Accounts receivable, allowance |
$ 609
|
$ 672
|
Series A convertible preferred stock, par value |
$ 0.001
|
$ 0.001
|
Series A convertible preferred stock, shares authorized |
10,000,000
|
10,000,000
|
Series A convertible preferred stock, shares outstanding |
21,908
|
22,358
|
Common stock, par value |
$ 0.001
|
$ 0.001
|
Common stock, shares authorized |
300,000,000
|
300,000,000
|
Common stock, shares issued |
82,132,777
|
80,949,697
|
Treasury stock, shares |
4,015
|
4,015
|
X |
- DefinitionAmount of allowance for credit loss on accounts receivable, classified as current.
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v3.24.1.1.u2
Statements of Operations (Unaudited) - USD ($) $ in Thousands |
3 Months Ended |
Mar. 31, 2024 |
Mar. 31, 2023 |
Revenue: |
|
|
Total revenue |
$ 6,880
|
$ 6,548
|
Cost of revenue: |
|
|
Total cost of revenue |
2,914
|
2,672
|
Gross margin |
3,966
|
3,876
|
Operating expenses: |
|
|
Research and development |
2,243
|
2,746
|
Sales and marketing |
3,003
|
3,148
|
General and administrative |
3,466
|
3,601
|
Total operating expenses |
8,712
|
9,495
|
Operating loss |
(4,746)
|
(5,619)
|
Interest income, net |
239
|
272
|
Net loss |
(4,507)
|
(5,347)
|
Cumulative dividend on convertible preferred stock |
(331)
|
(331)
|
Net loss attributable to common stockholders |
$ (4,838)
|
$ (5,678)
|
Net loss per share attributable to common stockholders: |
|
|
Basic |
$ (0.06)
|
$ (0.07)
|
Diluted |
$ (0.06)
|
$ (0.07)
|
Weighted average number of common shares and equivalents: |
|
|
Basic |
83,476,498
|
76,500,965
|
Diluted |
83,476,498
|
76,500,965
|
Systems [Member] |
|
|
Revenue: |
|
|
Total revenue |
$ 2,612
|
$ 1,821
|
Cost of revenue: |
|
|
Total cost of revenue |
1,900
|
1,697
|
Disposables Service and Accessories [Member] |
|
|
Revenue: |
|
|
Total revenue |
4,268
|
4,727
|
Cost of revenue: |
|
|
Total cost of revenue |
$ 1,014
|
$ 975
|
X |
- DefinitionThe aggregate cost of goods produced and sold and services rendered during the reporting period.
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v3.24.1.1.u2
Statements of Convertible Preferred Stock and Stockholders' Equity (Unaudited) - USD ($) $ in Thousands |
Convertible preferred stock series A [Member] |
Convertible preferred stock series B [Member] |
Common Stock [Member] |
Additional Paid-in Capital [Member] |
Treasury Stock, Common [Member] |
Retained Earnings [Member] |
Total |
Balance at Dec. 31, 2022 |
$ 5,583
|
$ 6
|
$ 75
|
$ 543,438
|
$ (206)
|
$ (516,967)
|
$ 26,346
|
Balance, shares at Dec. 31, 2022 |
22,383
|
5,610,121
|
74,874,459
|
|
|
|
|
Stock issued for the exercise of stock options |
|
|
|
33
|
|
|
33
|
Stock issued for the exercise of stock options, shares |
|
|
29,188
|
|
|
|
|
Stock-based compensation |
|
|
|
2,655
|
|
|
2,655
|
Stock-based compensation, shares |
|
|
144,054
|
|
|
|
|
Components of net loss |
|
|
|
|
|
(5,347)
|
(5,347)
|
Employee stock purchase plan |
|
|
|
23
|
|
|
23
|
Employee stock purchase plan, shares |
|
|
11,798
|
|
|
|
|
Balance at Mar. 31, 2023 |
$ 5,583
|
$ 6
|
$ 75
|
546,149
|
(206)
|
(522,314)
|
23,710
|
Balance, shares at Mar. 31, 2023 |
22,383
|
5,610,121
|
75,059,499
|
|
|
|
|
Balance at Dec. 31, 2023 |
$ 5,577
|
|
$ 81
|
554,148
|
(206)
|
(537,680)
|
16,343
|
Balance, shares at Dec. 31, 2023 |
22,358
|
|
80,949,697
|
|
|
|
|
Stock issued for the exercise of stock options |
|
|
|
8
|
|
|
8
|
Stock issued for the exercise of stock options, shares |
|
|
9,550
|
|
|
|
|
Stock-based compensation |
|
|
|
2,589
|
|
|
2,589
|
Stock-based compensation, shares |
|
|
161,474
|
|
|
|
|
Components of net loss |
|
|
|
|
|
(4,507)
|
(4,507)
|
Employee stock purchase plan |
|
|
|
22
|
|
|
22
|
Employee stock purchase plan, shares |
|
|
13,388
|
|
|
|
|
Preferred stock conversion |
$ (113)
|
|
$ 1
|
111
|
|
|
112
|
Preferred stock conversion, shares |
(450)
|
|
998,668
|
|
|
|
|
Balance at Mar. 31, 2024 |
$ 5,464
|
|
$ 82
|
$ 556,878
|
$ (206)
|
$ (542,187)
|
$ 14,567
|
Balance, shares at Mar. 31, 2024 |
21,908
|
|
82,132,777
|
|
|
|
|
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v3.24.1.1.u2
Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands |
3 Months Ended |
Mar. 31, 2024 |
Mar. 31, 2023 |
Cash flows from operating activities |
|
|
Net loss |
$ (4,507)
|
$ (5,347)
|
Adjustments to reconcile net loss to cash used in operating activities: |
|
|
Depreciation |
140
|
160
|
Non-cash lease expense |
3
|
7
|
Stock-based compensation |
2,589
|
2,655
|
Accretion and short-term investment discount |
|
(197)
|
Changes in operating assets and liabilities: |
|
|
Accounts receivable |
(131)
|
216
|
Inventories |
174
|
(97)
|
Prepaid expenses and other current assets |
(169)
|
(7)
|
Other assets |
21
|
24
|
Accounts payable |
117
|
563
|
Accrued liabilities |
192
|
(1,547)
|
Deferred revenue |
(775)
|
768
|
Net cash used in operating activities |
(2,346)
|
(2,802)
|
Cash flows from investing activities |
|
|
Purchase of property and equipment |
|
(349)
|
Net cash used in investing activities |
|
(349)
|
Cash flows from financing activities |
|
|
Proceeds from issuance of stock, net of issuance costs |
30
|
56
|
Net cash provided by financing activities |
30
|
56
|
Net decrease in cash, cash equivalents, and restricted cash |
(2,316)
|
(3,095)
|
Cash, cash equivalents, and restricted cash at beginning of period |
20,562
|
9,855
|
Cash, cash equivalents, and restricted cash at end of period |
18,246
|
6,760
|
Supplemental disclosure of cash flow information: |
|
|
Purchase of property and equipment included in accounts payable |
|
15
|
Reconciliation of cash, cash equivalents, and restricted cash to balance sheet as of March 31st: |
|
|
Cash and cash equivalents |
17,633
|
5,623
|
Restricted cash - current |
525
|
525
|
Restricted cash |
88
|
612
|
Total cash, cash equivalents, and restricted cash |
$ 18,246
|
$ 6,760
|
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v3.24.1.1.u2
Description of Business
|
3 Months Ended |
Mar. 31, 2024 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Description of Business |
1.
Description of Business
Stereotaxis
designs, manufactures and markets robotic systems, instruments and information systems for the interventional laboratory. Our proprietary
robotic technology, Robotic Magnetic Navigation, fundamentally transforms endovascular interventions using precise computer-controlled
magnetic fields to directly control the tip of flexible interventional catheters or devices. Direct control of the tip of an interventional
device, in contrast to all manual hand-held devices that are controlled from their handle, can improve the precision, stability, reach
and safety of these devices during procedures.
Our
primary clinical focus has been electrophysiology, specifically cardiac ablation procedures for the treatment of arrhythmias. Cardiac
ablation has become a well-accepted therapy for arrhythmias and a multi-billion-dollar medical device market with expectations for substantial
long-term growth. Our product strategy is to expand the clinical focus of our technology to several additional
endovascular indications including coronary, neuro, and peripheral interventions.
There
is substantial real-world evidence and clinical literature for Robotic Magnetic Navigation in electrophysiology. Hundreds of electrophysiologists
at over one hundred hospitals globally have treated over 100,000 arrhythmia patients with our robotic technology. Clinical use of our
technology has been documented in over 400 clinical publications. Robotic Magnetic Navigation is designed to enable physicians to complete
more complex interventional procedures with greater success and safety by providing image-guided delivery of catheters through the blood
vessels and chambers of the heart to treatment sites. This is achieved using externally applied computer-controlled magnetic fields that
govern the motion of the working tip of the catheter, resulting in improved navigation. The more flexible atraumatic design of catheters
driven using magnetic fields may reduce the risk of patient harm and other adverse events. Performing the procedure from a control cockpit
enables physicians to complete procedures in a safe location protected from x-ray exposure, with greater ergonomics, and improved efficiency.
We believe these benefits can be applicable in other endovascular indications where navigation through complex vasculature is often challenging
or unsuccessful and generates significant x-ray exposure, and we are investing in research and development in these areas.
Our
primary products include the Genesis RMN System, the Odyssey Solution, and other related devices. Through our strategic
relationships with fluoroscopy system manufacturers, providers of catheters and electrophysiology mapping systems, and other parties,
we offer our customers x-ray systems and other accessory devices.
The
Genesis RMN System is designed to enable physicians to complete more complex interventional procedures by providing image-guided
delivery of catheters through the blood vessels and chambers of the heart to treatment sites. This is achieved using externally applied
magnetic fields that govern the motion of the working tip of the catheter, resulting in improved navigation, efficient procedures, and
reduced x-ray exposure.
The
Odyssey Solution consolidates lab information onto one large integrated display, enabling physicians to view and control all the
key information in the operating room. This is designed to improve lab layout and procedure efficiency. The system also features a remote
viewing and recording capability called Odyssey Cinema, which is an innovative solution that delivers synchronized content for
optimized workflow, advanced care, and improved productivity. This tool includes an archiving capability that allows clinicians to store
and replay entire procedures or segments of procedures. This information can be accessed from locations throughout the hospital local
area network and over the global Odyssey Network providing physicians with a tool for clinical collaboration, remote consultation, and
training.
We
have arrangements with fluoroscopy system manufacturers to provide such systems in a bundled purchase offer for hospitals establishing
robotic interventional operating rooms. These are single-plane, full-power x-ray systems and include the c-arm and powered table. The
combination of RMN Systems with our partnered x-ray systems reduces the cost of acquisition, the ongoing cost of ownership, and the complexity
of installation of a robotic electrophysiology practice.
We
promote our full suite of products in a typical hospital implementation, subject to regulatory approvals or clearances. This implementation
requires a hospital to agree to an upfront capital payment and recurring payments. The upfront capital payment typically includes equipment
and installation charges. The recurring payments typically include disposable costs for each procedure, equipment service costs beyond
the warranty period, and ongoing software updates. In hospitals where our full suite of products has not been implemented, equipment
upgrade or expansion can be implemented upon purchasing of the necessary upgrade or expansion.
We
have received regulatory clearances and approvals necessary for us to market the Genesis RMN System in the U.S. and Europe, and
we are in the process of obtaining necessary registrations for extending our markets in other countries. The Niobe System, our
prior generation robotic magnetic navigation system, the Odyssey Solution, Cardiodrive, e-Contact, and various disposable
interventional devices have received regulatory clearances and approvals in the U.S., Europe, Canada, China, Japan and various other
countries. We have received the regulatory clearances and approvals that allow us to market the Vdrive and Vdrive Duo Systems
with the V-CAS device in the U.S. and Canada. We are pursuing regulatory approvals for the Stereotaxis MAGiC catheter, a robotically-navigated
magnetic ablation catheter designed to perform minimally invasive cardiac ablation procedures, in various global geographies. Approval
processes can be lengthy and uncertain, submissions may require revised or additional non-clinical and clinical data, and regulatory
applications could be denied.
We
have strategic relationships with technology leaders and innovators in the global interventional market. Through these strategic relationships
we provide compatibility between our robotic magnetic navigation system, x-ray systems, and digital imaging and 3D catheter location
sensing technology, as well as disposable interventional devices. The maintenance of these strategic relationships, or the establishment
of equivalent alternatives, is critical to our commercialization efforts. There are no guarantees that any existing strategic relationships
will continue, and efforts are ongoing to ensure the availability of compatible systems and devices and/or equivalent alternatives. We
cannot provide assurance as to the timeline of the ongoing availability of such compatible systems or our ability to obtain equivalent
alternatives on competitive terms or at all.
|
X |
- DefinitionThe entire disclosure for the nature of an entity's business, major products or services, principal markets including location, and the relative importance of its operations in each business and the basis for the determination, including but not limited to, assets, revenues, or earnings. For an entity that has not commenced principal operations, disclosures about the risks and uncertainties related to the activities in which the entity is currently engaged and an understanding of what those activities are being directed toward.
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v3.24.1.1.u2
Summary of Significant Accounting Policies
|
3 Months Ended |
Mar. 31, 2024 |
Accounting Policies [Abstract] |
|
Summary of Significant Accounting Policies |
2.
Summary of Significant Accounting Policies
Basis
of Presentation
The
accompanying unaudited financial statements of Stereotaxis, Inc. have been prepared in accordance with U.S. generally accepted accounting
principles (“GAAP”) for interim financial information and the instructions to Form 10-Q. Accordingly, they do not include
all the disclosures required by GAAP for complete financial statements. In the opinion of management, they include all adjustments, consisting
only of normal recurring adjustments, necessary for a fair presentation of the results for the interim periods presented. Operating results
for the three-month period ended March 31, 2024, are not necessarily indicative of the results that may be expected for the year ending
December 31, 2024, or for future operating periods.
These
interim financial statements and the related notes should be read in conjunction with the annual financial statements and notes included
in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission
(SEC) on March 8, 2024.
Risks
and Uncertainties
Future
results of operations could be materially adversely impacted by macroeconomic and geopolitical factors. The Company continues to experience
difficulties with periodic worldwide supply chain disruptions, including shortages and inflationary pressures, and logistics delays which
make it difficult for us to source parts and ship our products. We have generally been able to conduct normal business activities albeit
in a more deliberate manner than prior to the pandemic, including taking action to increase inventory levels and engaging in discussions
with our vendors on contractual obligations, but we cannot guarantee that they will not be impacted more severely in the future. Our
suppliers and contract manufacturers have experienced, and may continue to experience, similar difficulties. If our manufacturing operations
or supply chains are materially interrupted, it may not be possible for us to timely manufacture or service our products at required
levels, or at all. Changes in economic conditions and supply chain constraints could lead to higher inflation than previously experienced
or expected, which could, in turn, lead to an increase in costs. We may be unable to raise the prices of our products sufficiently to
keep up with the rate of inflation. A material reduction or interruption in any of our manufacturing processes or a substantial increase
in costs would have a material adverse effect on our business, operating results, and financial condition.
Many
of our hospital customers, for whom the purchase of our system involves a significant capital purchase which may be part of a larger
construction project at the customer site (typically the construction of a new building), may themselves be under economic pressures.
Hospitals continue to experience challenges with staffing and cost pressures as supply chain constraints and inflation drive up operating
costs. This may cause delays or cancellations of current purchase orders and other commitments and may exacerbate the long and variable
sales and installation cycles for our robotic magnetic navigation systems. Our hospital customers have also experienced challenges in
sourcing supplies, such as catheters, needed to perform procedures. Such shortages have, and may continue to, put pressure on procedures
and our disposable revenue.
Any
disruption to the capital markets could negatively impact our ability to raise capital. If the capital markets are disrupted for an extended
period of time and we need to raise additional capital, such capital may not be available on acceptable terms, or at all. Disruptions
to the capital markets and other financing sources could also negatively impact our hospital customers’ ability to raise capital
or otherwise obtain financing to fund their operations and capital projects. Such could result in delayed spending on current projects,
a longer sales cycle for new projects where a large capital commitment is required, and decreased demand for our disposable products
as well as an increased risk of customer defaults or delays in payments for our system installations, service contracts and disposable
products.
In
addition to the aforementioned macroeconomic factors, the COVID-19 pandemic negatively affected, and any resurgence of a variant of
COVID-19 or any similar occurrences may in the future negatively affect demand for both our systems and our disposable products. In
the past, we have experienced business disruptions, including travel restrictions on us and our third-party distributors, which
negatively affected our complex sales, marketing, installation, distribution and service network relating to our products and
services. We also experienced reductions in demand for our disposable products as our healthcare customers (physicians and
hospitals) re-prioritized the treatment of patients and diverted resources away from non-coronavirus areas, leading to the
performance of fewer procedures in which our disposable products are used. Significant decreases to our capital or recurring
revenues could have a material adverse effect on our business, operating results, and financial condition. While we cannot reliably
estimate the ultimate duration of the impact or the severity of ongoing periodic resurgences of pandemic-related issues, we continue
to anticipate periodic disruptions to our manufacturing operations, supply chains, procedures volumes, service activities, and
capital system orders and placements, any of which could have a material adverse effect on our business, financial condition,
results of operations, or cash flows. The impact has varied widely over time by individual geography.
Concentration
of Credit Risk
Financial
instruments that potentially subject the Company to concentration of credit risk consist of cash, cash equivalents and marketable securities.
Our investments may include, at any time, a diversified portfolio of cash equivalents and short- and long-term investments in a variety
of high-quality securities, including money market funds, U.S. treasury and U.S. government agency securities, corporate notes and bonds,
commercial paper, non-U.S. government agency securities, and municipal notes. The Company’s exposure to any individual corporate
entity is limited by policy. Deposits may exceed federally insured limits, and the Company is exposed to credit risk on deposits in the
event of default by the financial institutions to the extent account balances exceed the amount insured by the Federal Deposit Insurance
Corporation (FDIC). The Company closely monitors events involving limited liquidity, defaults, non-performance or other adverse developments
that affect financial institutions or other companies in the financial services industry or the financial services industry generally,
including Silicon Valley Bank. On March 10, 2023, Silicon Valley Bank (“SVB”), where the Company maintained accounts with
a cash balance of less than 6% of the Company’s total cash, cash equivalents and marketable securities, was closed by the California
Department of Financial Protection and Innovation and the FDIC was appointed as receiver. On March 12, 2023, the U.S. Department of the
Treasury, Federal Reserve Board, and FDIC released a joint statement announcing that the FDIC would complete its resolution of SVB in
a manner that fully protected all depositors at SVB and that depositors would have access to all of their money starting March 13, 2023.
On March 26, 2023, it was announced that First-Citizens Bank & Trust Company would assume all of SVB’s deposits and loans as
of March 27, 2023. During the periods presented, the Company has not experienced any losses on its deposits of cash, cash equivalents
or marketable securities.
Cash
and Cash Equivalents
Cash
and cash equivalents include cash on hand, money market instruments, and other highly liquid investments with original maturities of
three months or less from the date of purchase. Accrued interest receivable on money market instruments, included in other current assets, was less
than $0.1
million as of March 31, 2024, and December 31,
2023.
Restricted
Cash
Restricted
cash primarily consists of cash that the Company is obligated to maintain in accordance with contractual obligations. The Company’s
restricted cash was $0.6 million and $0.7 million as of March 31, 2024, and December 31, 2023, respectively.
Investments
Our
investments may include, at any time, a diversified portfolio of cash equivalents and short-and long-term investments in a variety of
high-quality securities, including money market funds, U.S. treasury and U.S. government agency securities, corporate notes and bonds,
commercial paper, non-U.S. government agency securities, and municipal notes. As of March 31, 2024, and December 31, 2023, the Company had no short-term investments.
Amortized
cost of U.S. treasury securities and marketable debt securities are based on the Company’s purchase price adjusted for accrual
of discount, or amortization of premium, and recognition of impairment charges, if any. The amortized cost of securities the Company
purchases at a discount or premium will equal the face or par value at maturity or the call date, if applicable. Stated interest on investments
is reported as income when earned and is adjusted for amortization or accretion of any premium or discount.
The
Company segments its portfolio based on the underlying risk profiles of the securities and has a zero-loss expectation for U.S. treasury
and U.S. government agency securities. The Company regularly reviews the securities using the probability of default method and analyzes
the unrealized loss positions and evaluates the current expected credit loss by considering factors such as credit ratings, issuer-specific
factors, current economic conditions, and reasonable and supportable forecasts. The Company did not have any material expected credit
losses on investments or material expected credit losses on accrued interest related to investments during the three months ended March
31, 2024, or year ended December 31, 2023.
Fair
Value Measurements
Financial
instruments consist of cash and cash equivalents, restricted cash, investments, accounts receivable, and accounts payable.
The
Company measures certain financial assets and liabilities at fair value on a recurring basis. General accounting principles for fair
value measurement establishes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value.
The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets and liabilities (“Level
1”) and the lowest priority to unobservable inputs (“Level 3”). The three levels of the fair value hierarchy are described
below:
Level
1: |
|
Values
are based on unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets
or liabilities. |
|
|
|
Level
2: |
|
Values
are based on quoted prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets
that are not active, or other model-based valuation techniques for which all significant assumptions are observable in the market. |
|
|
|
Level
3: |
|
Values
are generated from model-based techniques that use significant assumptions not observable in the market. |
As
of March 31, 2024, and December 31, 2023, financial assets classified as Level 2 consisted of money market funds. The Company reviews
trading activity and pricing for these investments as of the measurement date. When sufficient quoted pricing for identical securities
is not available, the Company uses market pricing and other observable market inputs for similar securities. These inputs either represent
quoted prices for similar assets in active markets or have been derived from observable market data. This approach results in the Level
2 classification of these securities within the fair value hierarchy.
Accounts
Receivable, Contract Assets, and Allowance for Credit Losses
Accounts
receivable primarily include amounts due from hospitals and distributors for acquisition of magnetic systems, associated disposable device
sales and service contracts, net of allowances for expected credit losses. Credit is granted on a limited basis, with balances due generally
within 30 days of billing. Contract assets primarily represent the difference between the revenue that was earned but not billed on service
contracts and revenue from system contracts that was recognized based on the relative selling price of the related performance obligations
and the contractual billing terms in the arrangements. The Company reports accounts receivable and contract
assets net of an allowance for expected credit losses in accordance with Accounting Standards Codification Topic 326, Financial Instruments
– Credit Losses (“ASC 326”). The provision for credit loss
is based upon management’s assessment of historical and expected net collections considering business and economic conditions and
other collection indicators. We assess collectability by reviewing the accounts receivable aging schedule on an aggregated basis where
similar characteristics exist and on an individual basis when we identify specific customers with known disputes or collectability issues.
Amounts deemed uncollectible are recorded as an allowance for expected credit losses.
Revenue
and Costs of Revenue
The
Company accounts for revenue in accordance with Accounting Standards Codification Topic 606 (“ASC 606”), Revenue from
Contracts with Customers.
We
generate revenue from the initial capital sales of systems as well as recurring revenue from the sale of our proprietary disposable devices,
from royalties paid to the Company on the sale of various devices as provided by co-development and co-placement arrangements, and from
other recurring revenue including ongoing software updates and service contracts.
We
account for a contract with a customer when there is a legally enforceable contract between the Company and the customer, the rights
of the parties are identified, the contract has commercial substance, and collectability of the contract consideration is probable. We
record our revenue based on consideration specified in the contract with each customer, net of any taxes collected from customers that
are remitted to government authorities.
For
contracts containing multiple products and services, the Company accounts for individual products and services as separate performance
obligations if they are distinct, which is if a product or service is separately identifiable from other items in the bundled package,
and if a customer can benefit from it on its own or with other resources that are readily available to the customer. The Company recognizes
revenues as the performance obligations are satisfied by transferring control of the product or service to a customer.
For
arrangements with multiple performance obligations, revenue is allocated to each performance obligation based on its relative standalone
selling price. Standalone selling prices are based on observable prices at which the Company separately sells the products or services.
If a standalone selling price is not directly observable, then the Company estimates the standalone selling price considering market
conditions and entity-specific factors including, but not limited to, features and functionality of the products and services and market
conditions. The Company regularly reviews standalone selling prices and updates these estimates if necessary.
Our
revenue recognition policy affects the following revenue streams in our business as follows:
Systems:
Contracts
related to the sale of systems typically contain separate obligations for the delivery of system(s), installation, service-type warranty,
and an implied obligation to provide software enhancements if and when available for one year following installation. Revenue is recognized
when the Company transfers control to the customer, which is generally at the point when acceptance occurs that indicates customer acknowledgment
of delivery or installation, depending on the terms of the arrangement. Revenue from service-type warranties and the implied obligation
to deliver software enhancements if and when available is included in Other Recurring Revenue and is recognized ratably typically over
the first year following installation of the system as the customer receives the service-type warranty and right to software updates
throughout the period. The Company’s system contracts generally do not provide a right of return. Systems are generally covered
by a one-year service-type warranty or a one-year assurance-type warranty. Assurance-type warranty costs were less than $0.1 million
for the three months ended March 31, 2024, and 2023. Revenue from system delivery and installation represented 38% and 28% of revenue
for the three months ended March 31, 2024, and 2023, respectively.
Disposables:
Revenue
from sales of disposable products is recognized when control is transferred to the customers, which generally occurs at the time of shipment,
but can also occur at the time of delivery depending on the customer arrangement. Disposable products are covered by an assurance type
warranty that provides for the return of defective products. Warranty costs were not material for the three months ended March 31, 2024,
and 2023. Disposable revenue represented 21% and 24% of revenue for the three months ended March 31, 2024, and 2023, respectively.
Royalty:
The
Company receives royalties on the sale of various devices as provided by co-development and co-placement arrangements with various manufacturers.
Royalty revenue represented less than 1% of revenue for the three months ended March 31, 2024, and 2023.
Other
Recurring Revenue:
Other
recurring revenue includes revenue from product maintenance plans, service-type warranties, other post warranty maintenance, and the
implied obligation to provide software enhancements if and when available for a specified period, typically one year following installation
of our systems. Revenue from services and software enhancements, service-type warranties, and the implied obligation to provide software
enhancements are deferred and amortized over the service or update period, which is typically one year. Revenue related to services performed
on a time-and-materials basis is recognized when performed. Other recurring revenue represented 41% and 48% of revenue for the three
months ended March 31, 2024, and 2023, respectively.
The
following table summarizes the Company’s revenue for systems, disposables, and service and accessories for the three months ended
March 31, 2024, and 2023 (in thousands):
Schedule of Revenue Disaggregated by Type
| |
2024 | | |
2023 | |
| |
Three Months Ended March 31, | |
| |
2024 | | |
2023 | |
Systems | |
$ | 2,612 | | |
$ | 1,821 | |
Disposables, service and accessories | |
| 4,268 | | |
| 4,727 | |
Total revenue | |
$ | 6,880 | | |
$ | 6,548 | |
Transaction
price allocated to remaining performance obligations relates to amounts allocated to products and services for which the revenue has
not yet been recognized. A significant portion of this amount relates to the Company’s systems contracts and obligations that will
be recognized as revenue in future periods. These obligations are generally satisfied within two years after contract inception but may
occasionally extend longer. Transaction price representing revenue to be earned on remaining performance obligations on system contracts
was approximately $11.9 million as of March 31, 2024. Performance obligations arising from contracts for disposables and service are
generally expected to be satisfied within one year after entering into the contract.
The
following table summarizes the Company’s contract assets and liabilities (in thousands):
Summary of Contract Assets and Liabilities
| |
March 31, 2024 | | |
December 31, 2023 | |
Contract Assets - unbilled receivables | |
$ | 77 | | |
$ | 72 | |
| |
| | | |
| | |
Customer deposits | |
$ | 1,850 | | |
$ | 2,105 | |
Product shipped, revenue deferred | |
| 1,509 | | |
| 1,413 | |
Deferred service and license fees | |
| 4,160 | | |
| 4,776 | |
Total deferred revenue | |
$ | 7,519 | | |
$ | 8,294 | |
Less: Long-term deferred revenue | |
| (1,581 | ) | |
| (1,637 | ) |
Total current deferred revenue | |
$ | 5,938 | | |
$ | 6,657 | |
The
Company invoices its customers based on the billing schedules in its sales arrangements. Contract assets primarily represent the difference
between the revenue that was earned but not billed on service contracts and revenue from system contracts that was recognized based on
the relative selling price of the related performance obligations and the contractual billing terms in the arrangements. Customer deposits
primarily relate to future system sales but can also include deposits on disposable sales. Deferred revenue is primarily related to service
contracts, for which the service fees are billed up-front, generally quarterly or annually, and for amounts billed in advance for system
contracts for which some performance obligations remain outstanding. For service contracts, the associated deferred revenue is generally
recognized ratably over the service period. For system contracts, the associated deferred revenue is recognized when the remaining performance
obligations are satisfied. The Company did not have any impairment losses on its contract assets for the periods presented.
Revenue
recognized for the three months ended March 31, 2024, and 2023, that was included in the deferred revenue balance at the beginning of
each reporting period was $3.0 million.
Assets
Recognized from the Costs to Obtain a Contract with a Customer
The
Company has determined that sales incentive programs for the Company’s sales team meet the requirements to be capitalized as the
Company expects to generate future economic benefits from the related revenue generating contracts after the initial capital sales transaction.
The costs capitalized as contract acquisition costs included in prepaid expenses and other assets, in the Company’s balance sheet
were $0.1 million as of March 31, 2024, and December 31, 2023. The Company did not incur any impairment losses during any of the periods
presented.
Costs
of systems revenue include direct product costs, installation labor and other costs including estimated assurance-type warranty costs,
and initial training costs, when applicable. These costs are recognized at the time of sale. Costs of disposable revenue include direct
product costs and estimated warranty costs and are recognized at the time of sale. Cost of revenue from services and license fees are
recognized when incurred.
Leasing
Arrangements
A
lease is defined as a contract, or part of a contract, that conveys the right to control the use of identified property, plant or equipment
for a period of time in exchange for consideration. The Company accounts for leases in accordance with Accounting Standards Update No.
2016-02 “Leases” (Topic 842) and all subsequent ASUs that modified Topic 842 (“ASC 842”). The Company determines
if an arrangement contains a lease at inception.
The
Company leases its facilities under operating leases. In accordance with ASC 842, operating lease agreements are recognized on the balance
sheet as a right-of-use (“ROU”) asset and a corresponding lease liability. These leases generally do not have significant
rent escalation holidays, concessions, leasehold improvement incentives, or other build-out clauses. Further, the leases do not contain
contingent rent provisions. Many of our leases include both lease (i.e., fixed payments including rent, taxes, and insurance costs) and
non-lease components (i.e., common-area or other maintenance costs) which are accounted for as a single lease component as we have elected
the practical expedient to group lease and non-lease components for all leases.
The
Company’s lease agreements often include one or more options to renew at the Company’s discretion. If at lease inception,
the Company considers the exercising of a renewal option to be reasonably certain, the Company will include the extended term in the
calculation of the ROU asset and lease liability. The Company elected not to include short-term leases (i.e., leases with initial terms
of twelve months or less) on the balance sheet.
The
calculated amounts of the ROU assets and lease liabilities are impacted by the length of the lease term and the discount rate used to
calculate the present value of the minimum lease payments. ASC 842 requires the use of the discount rate implicit in the lease whenever
this rate is readily determinable. As this rate is rarely determinable, the Company utilizes its incremental borrowing rate at lease
inception.
Stock-Based
Compensation
The
Company accounts for its grants of stock options, non-qualified stock options, stock appreciation rights, restricted shares,
restricted stock units and for its employee stock purchase plan in accordance with the provisions of general accounting principles
for share-based payments. These accounting principles require the determination of the fair value of the stock-based compensation at
the grant date and the recognition of the related expense over the period in which the stock-based compensation vests.
For
time-based awards, the Company utilizes the Black-Scholes valuation model to determine the fair value of stock options and stock
appreciation rights at the date of grant. The weighted average assumptions and fair value for options granted during the three
months ended March 31, 2024, were 1) expected dividend rate of 0%;
2) expected volatility of 76%
based on the Company’s historical volatility; 3) risk-free interest rate based on the Treasury yield on the date of grant; and
4) expected term of 6.25
years. The resulting compensation expense is recognized over the requisite service period, which is generally four years. Restricted
shares and units granted to employees and non-employee directors are valued at the fair market value at the date of grant. The
Company amortizes the fair market value to expense over the service period, which is generally four years except for grants to directors which are generally earned over a period of six months. If the shares are subject to performance objectives, the
resulting compensation expense is amortized over the anticipated vesting period and is subject to adjustment based on the actual
achievement of objectives.
For
market-based awards, stock-based compensation expense is recognized over the minimum service period regardless of whether or not the
market target is probable of being achieved. The fair value of such awards is estimated on the grant date using Monte Carlo simulations.
Shares
purchased by employees under the 2022 Employee Stock Purchase Plans are considered to be non-compensatory.
Net
Loss per Common Share
Basic
earnings (loss) per common share is computed by dividing the net earnings (loss) for the period by the weighted average number of common
shares outstanding during the period. In periods where there is net income, we apply the two-class method to calculate basic and diluted
net income (loss) per share of common stock, as our convertible preferred stock is a participating security. The two-class method is
an earnings allocation formula that treats a participating security as having rights to earnings that otherwise would have been available
to common stockholders. In periods where there is a net loss, the two-class method of computing earnings per share does not apply as
our convertible preferred stock does not contractually participate in our losses. We compute diluted net income (loss) per common share
using net income (loss) as the “control number” in determining whether potential common shares are dilutive, after giving
consideration to all potentially dilutive common shares, including stock options, warrants, unvested restricted stock units outstanding
during the period and potential issuance of stock upon the conversion of our convertible preferred stock issued and outstanding during
the period, except where the effect of such securities would be antidilutive.
The
following table sets forth the computation of basic and diluted EPS (in thousands except for share and per share amounts):
Schedule
of Computation of Basic and Diluted Earnings Per Share
| |
2024 | | |
2023 | |
| |
Three Months Ended March 31, | |
| |
2024 | | |
2023 | |
Net loss | |
$ | (4,507 | ) | |
$ | (5,347 | ) |
Cumulative dividend on convertible preferred stock | |
| (331 | ) | |
| (331 | ) |
Net loss attributable to common stockholders | |
$ | (4,838 | ) | |
$ | (5,678 | ) |
| |
| | | |
| | |
Weighted average number of common shares and equivalents: | |
| 83,476,498 | | |
| 76,500,965 | |
Basic EPS | |
$ | (0.06 | ) | |
$ | (0.07 | ) |
Diluted EPS | |
$ | (0.06 | ) | |
$ | (0.07 | ) |
The
Company did not include any portion of unearned restricted shares, outstanding options, stock appreciation rights, warrants or convertible
preferred stock in the calculation of diluted loss per common share because all such securities are anti-dilutive for all periods presented.
The application of the two-class method of computing earnings per share under general accounting principles for participating securities
is not applicable during these periods because those securities do not contractually participate in its losses.
As
of March 31, 2024, the Company had 3,470,733 shares of common stock issuable upon the exercise of outstanding options and stock appreciation
rights at a weighted average exercise price of $3.92 per share, 48,885,547 shares of our common stock issuable upon conversion of our
Series A Convertible Preferred Stock and 1,741,741 shares of unvested restricted share units. The Company had no unearned restricted
shares outstanding as of March 31, 2024.
Recently
Issued Accounting Pronouncements
In
June 2016, the FASB issued ASU 2016-13, “Financial Instruments-Credit Losses (Topic 326), Measurement of Credit Losses on Financial
Instruments” and also issued subsequent amendments to the initial guidance under ASU 2018-19, ASU 2019-04 and ASU 2019-05. The
standard modifies the measurement approach for credit losses on financial instruments, including trade receivables, from an incurred
loss method to a current expected credit loss method, otherwise known as “CECL.” The standard requires the measurement of
expected credit losses to be based on relevant information, including historical experience, current conditions and a forecast that is
supportable. The Company adopted the standard in the first quarter of 2023. The impact to the Company’s financial results was immaterial.
In
December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”),
which requires enhanced income tax disclosures, primarily related to the effective tax rate reconciliation and income taxes paid. The
Company does not expect a significant impact on its income tax disclosures upon adoption of the ASU which will be effective in the Company’s
year ending December 31, 2025.
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Financial Instruments
|
3 Months Ended |
Mar. 31, 2024 |
Investments, All Other Investments [Abstract] |
|
Financial Instruments |
3.
Financial Instruments
The
following tables summarize the Company’s cash and fair value by significant category reported as cash and cash equivalents and
restricted cash as of March 31, 2024, and December 31, 2023:
Schedule
of Cash and Cash Equivalents, Restricted Cash and Investments
| |
March 31, 2024 | |
| |
Valuation | | |
Reported as: | |
(in thousands) | |
Amortized
Cost | | |
Gross
Unrealized
Gains | | |
Gross
Unrealized
Losses | | |
Fair
Value | | |
Cash and
Cash Equivalents | | |
Restricted
Cash-
current | | |
Short-
term
Investments | | |
Restricted
Cash | |
Cash | |
$ | 1,662 | | |
$ | - | | |
$ | - | | |
$ | 1,662 | | |
$ | 1,662 | | |
$ | - | | |
$ | - | | |
$ | - | |
Level 2 | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Money market funds | |
| 16,584 | | |
| - | | |
| - | | |
| 16,584 | | |
| 15,971 | | |
| 525 | | |
| - | | |
| 88 | |
Subtotal | |
| 16,584 | | |
| - | | |
| - | | |
| 16,584 | | |
| 15,971 | | |
| 525 | | |
| - | | |
| 88 | |
Total assets measured at fair value | |
$ | 18,246 | | |
$ | - | | |
$ | - | | |
$ | 18,246 | | |
$ | 17,633 | | |
$ | 525 | | |
$ | - | | |
$ | 88 | |
| |
December 31, 2023 | |
| |
Valuation | | |
Reported as: | |
(in thousands) | |
Amortized
Cost | | |
Gross
Unrealized
Gains | | |
Gross
Unrealized
Losses | | |
Fair
Value | | |
Cash and
Cash
Equivalents | | |
Restricted
Cash-
current | | |
Short-
term
Investments | | |
Restricted
Cash | |
Cash | |
$ | 2,122 | | |
$ | - | | |
$ | - | | |
$ | 2,122 | | |
$ | 2,122 | | |
$ | - | | |
$ | - | | |
$ | - | |
Level 2 | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Money market funds | |
| 18,440 | | |
| - | | |
| - | | |
| 18,440 | | |
| 17,696 | | |
| 525 | | |
| - | | |
| 219 | |
Subtotal | |
| 18,440 | | |
| - | | |
| - | | |
| 18,440 | | |
| 17,696 | | |
| 525 | | |
| - | | |
| 219 | |
Total assets measured at fair value | |
$ | 20,562 | | |
$ | - | | |
$ | - | | |
$ | 20,562 | | |
$ | 19,818 | | |
$ | 525 | | |
$ | - | | |
$ | 219 | |
Interest
income was approximately $0.2 million and $1.1 million during the three months ended March 31, 2024, and
the year ended December 31, 2023, respectively.
As
of March 31, 2024, and December 31, 2023, the Company did not have any financial assets classified as Level 1 or Level 3 nor did the
Company have financial liabilities valued at fair value on a recurring basis.
|
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- DefinitionThe entire disclosure for financial instruments. This disclosure includes, but is not limited to, fair value measurements of short and long term marketable securities, international currencies forward contracts, and auction rate securities. Financial instruments may include hedging and non-hedging currency exchange instruments, derivatives, securitizations and securities available for sale at fair value. Also included are investment results, realized and unrealized gains and losses as well as impairments and risk management disclosures.
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Inventories
|
3 Months Ended |
Mar. 31, 2024 |
Inventory Disclosure [Abstract] |
|
Inventories |
4.
Inventories
Inventories
consist of the following (in thousands):
Schedule of Inventories
| |
March 31, 2024 | | |
December 31, 2023 | |
Raw materials | |
$ | 6,507 | | |
$ | 5,918 | |
Work in process | |
| 457 | | |
| 1,034 | |
Finished goods | |
| 3,255 | | |
| 3,413 | |
Reserve for excess and obsolescence | |
| (1,967 | ) | |
| (1,939 | ) |
Total inventory | |
$ | 8,252 | | |
$ | 8,426 | |
The
reserve for excess and obsolescence primarily includes Niobe Systems and related raw materials and spare parts.
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Prepaid Expenses and Other Assets
|
3 Months Ended |
Mar. 31, 2024 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] |
|
Prepaid Expenses and Other Assets |
5.
Prepaid Expenses and Other Assets
Prepaid
expenses and other assets consist of the following (in thousands):
Schedule of Prepaid Expenses and Other Assets
| |
March 31, 2024 | | |
December 31, 2023 | |
Prepaid expenses | |
$ | 465 | | |
$ | 181 | |
Prepaid commissions | |
| 92 | | |
| 110 | |
Deposits | |
| 284 | | |
| 424 | |
Other assets | |
| 120 | | |
| 98 | |
Total prepaid expenses and other assets | |
| 961 | | |
| 813 | |
Less: Noncurrent prepaid expenses and other assets | |
| (116 | ) | |
| (137 | ) |
Total current prepaid expenses and other assets | |
$ | 845 | | |
$ | 676 | |
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Property and Equipment
|
3 Months Ended |
Mar. 31, 2024 |
Property, Plant and Equipment [Abstract] |
|
Property and Equipment |
6.
Property and Equipment
Property
and Equipment consist of the following (in thousands):
Schedule of Property and Equipment
| |
March 31, 2024 | | |
December 31, 2023 | |
Equipment | |
$ | 4,269 | | |
$ | 4,269 | |
Leasehold improvements | |
| 2,911 | | |
| 2,911 | |
Gross property and equipment | |
| 7,180 | | |
| 7,180 | |
Less: Accumulated depreciation | |
| (4,016 | ) | |
| (3,876 | ) |
Net property and equipment | |
$ | 3,164 | | |
$ | 3,304 | |
The
Company had no additions of property and equipment during the three months ended March 31, 2024, and had less than $0.1 million of property
and equipment additions during the year ended December 31, 2023, associated with the buildout of the new leased space in St. Louis, Missouri.
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- DefinitionThe entire disclosure for long-lived, physical asset used in normal conduct of business and not intended for resale. Includes, but is not limited to, work of art, historical treasure, and similar asset classified as collections.
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v3.24.1.1.u2
Leases
|
3 Months Ended |
Mar. 31, 2024 |
Leases |
|
Leases |
7.
Leases
On
March 1, 2021, the Company entered into an office lease agreement (the “Lease”) with Globe Building Company (the “Landlord”),
under which the Company leases executive office space and manufacturing facilities of approximately 43,100 square feet of rentable space
located at 710 N. Tucker Boulevard, St. Louis, Missouri (the “Premises”) that serves as the Company’s principal executive
and administrative offices and manufacturing facility. Lease payments commenced on January 1, 2022, and the lease has a term of ten years,
with two renewal options of five years each. The minimum annual rent under the terms of the Lease ranges from approximately $0.8 million
in 2022 to $1.0 million in 2031.
As
of March 31, 2024, the weighted average discount rate for operating leases was 9% and the weighted average remaining lease term for operating
lease term is 7.74 years.
The
following table represents lease costs and other lease information (in thousands):
Schedule of Lease Costs and Other Lease Information
| |
2024 | | |
2023 | |
| |
Three Months Ended March 31, | |
| |
2024 | | |
2023 | |
Operating lease cost | |
$ | 227 | | |
$ | 227 | |
Short-term lease cost | |
| 3 | | |
| 4 | |
Total net lease cost | |
$ | 230 | | |
$ | 231 | |
| |
| | | |
| | |
Cash paid within operating cash flows | |
$ | 258 | | |
$ | 242 | |
Variable
lease costs consist primarily of taxes, insurance, and common area or other maintenance costs for our leased facilities and equipment
which are paid based on actual costs incurred.
Future
minimum payments for operating leases with initial or remaining terms of one year or more as of March 31, 2024, were as follows (in thousands):
Schedule of Future Minimum Operating Lease Payments
| |
March 31, 2024 | |
2024 | |
$ | 674 | |
2025 | |
| 919 | |
2026 | |
| 935 | |
2027 | |
| 956 | |
2028 | |
| 976 | |
2029 and thereafter | |
| 3,054 | |
Total lease payments | |
| 7,514 | |
Less: Interest | |
| (2,126 | ) |
Present value of lease liabilities | |
$ | 5,388 | |
|
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v3.24.1.1.u2
Accrued Liabilities
|
3 Months Ended |
Mar. 31, 2024 |
Payables and Accruals [Abstract] |
|
Accrued Liabilities |
8.
Accrued Liabilities
Accrued
liabilities consist of the following (in thousands):
Schedule of Accrued Liabilities
| |
March 31, 2024 | | |
December 31, 2023 | |
Accrued salaries, bonus, and benefits | |
$ | 1,210 | | |
$ | 1,222 | |
Accrued licenses and maintenance fees | |
| 484 | | |
| 484 | |
Accrued warranties | |
| 90 | | |
| 107 | |
Accrued professional services | |
| 109 | | |
| 138 | |
Accrued investigational sites | |
| 182 | | |
| - | |
Deferred contract obligation | |
| 1,045 | | |
| 1,045 | |
Other | |
| 87 | | |
| 19 | |
Total accrued liabilities | |
| 3,207 | | |
| 3,015 | |
Less: Long term accrued liabilities | |
| (43 | ) | |
| (43 | ) |
Total current accrued liabilities | |
$ | 3,164 | | |
$ | 2,972 | |
|
X |
- DefinitionThe entire disclosure for accounts payable and accrued liabilities at the end of the reporting period.
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v3.24.1.1.u2
Convertible Preferred Stock and Stockholders’ Equity
|
3 Months Ended |
Mar. 31, 2024 |
Equity [Abstract] |
|
Convertible Preferred Stock and Stockholders’ Equity |
9.
Convertible Preferred Stock and Stockholders’ Equity
The
holders of common stock are entitled to one vote for each share held and to receive dividends when and as declared by the Board of Directors
out of funds legally available for dividends, subject to the prior rights or preferences applicable to any preferred stock as may then
be outstanding. No dividends have been declared or paid as of March 31, 2024, and the Company does not presently intend to pay any cash
dividends in the foreseeable future.
Series
A Convertible Preferred Stock and Warrants
In
September 2016, the Company issued (i) 24,000 shares of Series A Convertible Preferred Stock (the “Series A Preferred Stock”),
par value $0.001 per share, with a stated value of $1,000 per share, which are convertible into shares of the Company’s common
stock at an initial conversion rate of $0.65 per share, subject to adjustment for events such as stock splits, combinations and the like
as provided in the certificate of designations covering such Series A Preferred Stock, and (ii) (the SPA Warrants) to purchase an aggregate
of 36,923,078 shares of common stock. The shares of Series A Preferred Stock are entitled to vote on an as-converted basis with the common
stock, subject to specified beneficial ownership issuance limitations. The Series A Preferred Stock bear dividends at a rate of six percent
(6%) per annum, which are cumulative and accrue daily from the date of issuance on the $1,000 stated value. Such dividends will not be
paid in cash except in connection with any liquidation, dissolution or winding up of the Company or any redemption of the Series A Preferred
Stock. Each holder of convertible preferred shares has the right to require us to redeem such holder’s shares of Series A Preferred
Stock upon the occurrence of specified events, which include certain business combinations, the sale of all or substantially all of the
Company’s assets, or the sale of more than 50% of the outstanding shares of the Company’s common stock. In addition, the
Company has the right to redeem the Series A Preferred Stock in the event of a defined change of control. The Series A Preferred Stock
ranks senior to our common stock as to distributions and payments upon the liquidation, dissolution, and winding up of the Company. Since
the Series A Preferred Stock are subject to conditions for redemption that are outside the Company’s control, the Series A Preferred
Stock are presently reported in the mezzanine section of the balance sheet.
2021
CEO Performance Award Unit Grant
On
February 23, 2021, the Company`s Board of Directors, upon recommendation of the Compensation Committee, approved the grant of the CEO
Performance Award to the Company’s Chief Executive Officer. The CEO Performance award is a 10-year performance award of up to 13,000,000
shares, tied to the achievement of market capitalization milestones and subject to minimum service requirements.
As
detailed in the table below, the CEO Performance Award consists of ten vesting tranches. The first market capitalization milestone is
$1.0 billion, and each of the remaining nine market capitalization milestones are in additional $500 million increments, up to $5.5 billion.
Summary of Performance Award And Market Capitalization Milestones
Tranche # | |
No. of Shares Subject to PSU | | |
Market Capitalization Milestones(1) | |
1 | |
| 1,000,000 | | |
$ | 1,000,000,000 | |
2 | |
| 1,500,000 | | |
$ | 1,500,000,000 | |
3 | |
| 1,500,000 | | |
$ | 2,000,000,000 | |
4 | |
| 2,000,000 | | |
$ | 2,500,000,000 | |
5 | |
| 1,000,000 | | |
$ | 3,000,000,000 | |
6 | |
| 1,000,000 | | |
$ | 3,500,000,000 | |
7 | |
| 1,000,000 | | |
$ | 4,000,000,000 | |
8 | |
| 2,000,000 | | |
$ | 4,500,000,000 | |
9 | |
| 1,000,000 | | |
$ | 5,000,000,000 | |
10 | |
| 1,000,000 | | |
$ | 5,500,000,000 | |
Total: | |
| 13,000,000 | | |
| | |
Each
tranche represents a portion of the PSUs covering the number of shares outlined in the table above. Each tranche vests upon (i) satisfaction
of the market capitalization milestones and (ii) continued employment as CEO of the Company from the grant date through December 31,
2030. Absent an earlier termination, the PSUs will expire on December 31, 2030. If our CEO ceases employment as CEO of the Company for
any reason including death, disability, termination for cause or without cause (as defined in the award agreement), or if he voluntary
terminates after service as CEO for at least five years, the remaining service period will be waived and he will retain any PSUs that
have vested through the date of termination.
The
Company received Shareholder approval at its annual meeting on May 20, 2021, for shares to be issued under the award.
The
market capitalization requirement is considered a market condition under FASB Accounting Standards Codification Topic 718 “Compensation
– Stock Compensation” and is estimated on the grant date using Monte Carlo simulations. Recognition of stock-based compensation
expense of all the tranches commenced on February 23, 2021, the date of grant, as the probability of meeting the ten market capitalization
milestones is not considered in determining the timing of expense recognition. The expense will be recognized on an accelerated basis
through 2030. Key assumptions for estimating the performance-based awards fair value at the date of grant included share price on grant
date, volatility of the Company’s common stock price, risk free interest rate, and grant term.
Total
stock-based compensation recorded as operating expense for the CEO Performance Award was $1.8 million for the three months ended March
31, 2024, and 2023. As of March 31, 2024, and 2023, the Company had approximately $35.2 million and $42.4 million, respectively, of total
unrecognized stock-based compensation expense remaining under the CEO Performance Award assuming the grantee’s continued employment
as CEO of the Company, or in a similar capacity, through 2030. As of March 31, 2024, none of the performance milestones established by
the 2021 CEO Incentive Program have been achieved, and no awards have been earned.
Stock
Award Plans
In
February 2022, the Compensation Committee of the Board of Directors adopted the 2022 Stock Incentive Plan (the “Plan”) which
was subsequently approved by the Company’s shareholders. This plan replaced the 2012 Stock Incentive Plan which expired on May
19, 2022. The 2022 Stock Incentive Plan allows for the grant of incentive stock options, non-qualified stock options, stock appreciation
rights, restricted shares and restricted share units to employees, non-employee directors, and third-party consultants.
At
March 31, 2024, the Company had 2,297,196 remaining shares of the Company’s common stock to provide for current and future grants
under its various equity plans.
At
March 31, 2024, the total compensation cost related to options and non-vested stock granted to employees
and non-employees under the Company’s stock award plans but not yet recognized was approximately $3.0 million, excluding compensation
not yet recognized related to the CEO Performance Award discussed above. This cost will be amortized over a period of up to four years
over the underlying estimated service periods and will be adjusted for subsequent changes in actual forfeitures and anticipated vesting
periods.
A
summary of the option and stock appreciation rights activity for the three-month period ended March 31, 2024, is as follows:
Summary of Option and Stock Appreciation Rights Activity
| |
Number of Options/SARs | | |
Range of Exercise Price | | |
Weighted Average Exercise Price per Share | |
Outstanding, December 31, 2023 | |
| 3,650,115 | | |
| $0.74 - $9.87 | | |
$ | 3.93 | |
Granted | |
| 20,000 | | |
| $2.80 | | |
$ | 2.80 | |
Exercised | |
| (9,550 | ) | |
| $0.74 - $2.03 | | |
$ | 0.80 | |
Forfeited | |
| (189,832 | ) | |
| $0.74 - $6.96 | | |
$ | 4.03 | |
Outstanding, March 31, 2024 | |
| 3,470,733 | | |
| $0.74 - $9.87 | | |
$ | 3.92 | |
A
summary of the restricted stock unit activity for the three-month period ended March 31, 2024, is as follows:
Summary of Restricted Stock Unit Activity
| |
Number of Restricted Stock Units | | |
Weighted Average Grant Date Fair Value per Unit | |
Outstanding, December 31, 2023 | |
| 1,502,131 | | |
$ | 3.94 | |
Granted | |
| 389,610 | | |
$ | 1.54 | |
Vested | |
| (150,000 | ) | |
$ | 1.19 | |
Outstanding, March 31, 2024 | |
| 1,741,741 | | |
$ | 3.64 | |
|
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Product Warranty Provisions
|
3 Months Ended |
Mar. 31, 2024 |
Guarantees and Product Warranties [Abstract] |
|
Product Warranty Provisions |
10.
Product Warranty Provisions
The
Company’s standard policy is to warrant all capital systems against defects in material or workmanship for one year following installation.
The Company’s estimate of costs to service the warranty obligations is based on historical experience and current product performance
trends. A regular review of warranty obligations is performed to determine the adequacy of the reserve and adjustments are made to the
estimated warranty liability as appropriate.
Accrued
warranty, which is included in other accrued liabilities, consists of the following (in thousands):
Schedule
of Accrued Warranty
| |
March 31, 2024 | | |
December 31, 2023 | |
Warranty accrual, beginning of the fiscal period | |
$ | 107 | | |
$ | 163 | |
Accrual adjustment for product warranty | |
| (1 | ) | |
| 547 | |
Payments made | |
| (16 | ) | |
| (603 | ) |
Warranty accrual, end of the fiscal period | |
$ | 90 | | |
$ | 107 | |
|
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Commitments and Contingencies
|
3 Months Ended |
Mar. 31, 2024 |
Commitments and Contingencies Disclosure [Abstract] |
|
Commitments and Contingencies |
11.
Commitments and Contingencies
The
Company at times becomes a party to claims in the ordinary course of business. Management believes that the ultimate resolution of
pending or threatened proceedings will not have a material effect on the financial position, results of operations or liquidity of
the Company. In February 2024, a vendor filed financing statements under the Uniform Commercial Code (“UCC”) on
underlying inventory for approximately $0.6
million. We believe the financing statements were filed without merit, and we fully intend on contesting the propriety of such
actions.
In
April 2021, the Company entered into a letter of credit pursuant to the Lease agreement totaling approximately $1.8 million to be delivered
in four equal installments of which the first was delivered in April 2021, the second was delivered in July 2021, the third was delivered
in October 2021, and the fourth was delivered in January 2022. The amount available under this letter of credit automatically reduces
by one fortieth at the end of each month during the lease term.
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Subsequent Events
|
3 Months Ended |
Mar. 31, 2024 |
Subsequent Events [Abstract] |
|
Subsequent Events |
12.
Subsequent Events
On
May 11, 2024, the Company entered into a definitive share purchase agreement to acquire all of the outstanding equity capital stock of
Access Point Technologies, Inc., a privately-held Minnesota-based developer of innovative electrophysiology catheters, for $3.0 million
of Company common stock at closing and, in addition, Company common stock contingently issuable over five years after closing upon achieving
certain key regulatory and commercial milestones. The acquisition is expected to close by the end of the third quarter of 2024 subject
to customary closing conditions.
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Summary of Significant Accounting Policies (Policies)
|
3 Months Ended |
Mar. 31, 2024 |
Accounting Policies [Abstract] |
|
Basis of Presentation |
Basis
of Presentation
The
accompanying unaudited financial statements of Stereotaxis, Inc. have been prepared in accordance with U.S. generally accepted accounting
principles (“GAAP”) for interim financial information and the instructions to Form 10-Q. Accordingly, they do not include
all the disclosures required by GAAP for complete financial statements. In the opinion of management, they include all adjustments, consisting
only of normal recurring adjustments, necessary for a fair presentation of the results for the interim periods presented. Operating results
for the three-month period ended March 31, 2024, are not necessarily indicative of the results that may be expected for the year ending
December 31, 2024, or for future operating periods.
These
interim financial statements and the related notes should be read in conjunction with the annual financial statements and notes included
in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission
(SEC) on March 8, 2024.
|
Risks and Uncertainties |
Risks
and Uncertainties
Future
results of operations could be materially adversely impacted by macroeconomic and geopolitical factors. The Company continues to experience
difficulties with periodic worldwide supply chain disruptions, including shortages and inflationary pressures, and logistics delays which
make it difficult for us to source parts and ship our products. We have generally been able to conduct normal business activities albeit
in a more deliberate manner than prior to the pandemic, including taking action to increase inventory levels and engaging in discussions
with our vendors on contractual obligations, but we cannot guarantee that they will not be impacted more severely in the future. Our
suppliers and contract manufacturers have experienced, and may continue to experience, similar difficulties. If our manufacturing operations
or supply chains are materially interrupted, it may not be possible for us to timely manufacture or service our products at required
levels, or at all. Changes in economic conditions and supply chain constraints could lead to higher inflation than previously experienced
or expected, which could, in turn, lead to an increase in costs. We may be unable to raise the prices of our products sufficiently to
keep up with the rate of inflation. A material reduction or interruption in any of our manufacturing processes or a substantial increase
in costs would have a material adverse effect on our business, operating results, and financial condition.
Many
of our hospital customers, for whom the purchase of our system involves a significant capital purchase which may be part of a larger
construction project at the customer site (typically the construction of a new building), may themselves be under economic pressures.
Hospitals continue to experience challenges with staffing and cost pressures as supply chain constraints and inflation drive up operating
costs. This may cause delays or cancellations of current purchase orders and other commitments and may exacerbate the long and variable
sales and installation cycles for our robotic magnetic navigation systems. Our hospital customers have also experienced challenges in
sourcing supplies, such as catheters, needed to perform procedures. Such shortages have, and may continue to, put pressure on procedures
and our disposable revenue.
Any
disruption to the capital markets could negatively impact our ability to raise capital. If the capital markets are disrupted for an extended
period of time and we need to raise additional capital, such capital may not be available on acceptable terms, or at all. Disruptions
to the capital markets and other financing sources could also negatively impact our hospital customers’ ability to raise capital
or otherwise obtain financing to fund their operations and capital projects. Such could result in delayed spending on current projects,
a longer sales cycle for new projects where a large capital commitment is required, and decreased demand for our disposable products
as well as an increased risk of customer defaults or delays in payments for our system installations, service contracts and disposable
products.
In
addition to the aforementioned macroeconomic factors, the COVID-19 pandemic negatively affected, and any resurgence of a variant of
COVID-19 or any similar occurrences may in the future negatively affect demand for both our systems and our disposable products. In
the past, we have experienced business disruptions, including travel restrictions on us and our third-party distributors, which
negatively affected our complex sales, marketing, installation, distribution and service network relating to our products and
services. We also experienced reductions in demand for our disposable products as our healthcare customers (physicians and
hospitals) re-prioritized the treatment of patients and diverted resources away from non-coronavirus areas, leading to the
performance of fewer procedures in which our disposable products are used. Significant decreases to our capital or recurring
revenues could have a material adverse effect on our business, operating results, and financial condition. While we cannot reliably
estimate the ultimate duration of the impact or the severity of ongoing periodic resurgences of pandemic-related issues, we continue
to anticipate periodic disruptions to our manufacturing operations, supply chains, procedures volumes, service activities, and
capital system orders and placements, any of which could have a material adverse effect on our business, financial condition,
results of operations, or cash flows. The impact has varied widely over time by individual geography.
|
Concentration of Credit Risk |
Concentration
of Credit Risk
Financial
instruments that potentially subject the Company to concentration of credit risk consist of cash, cash equivalents and marketable securities.
Our investments may include, at any time, a diversified portfolio of cash equivalents and short- and long-term investments in a variety
of high-quality securities, including money market funds, U.S. treasury and U.S. government agency securities, corporate notes and bonds,
commercial paper, non-U.S. government agency securities, and municipal notes. The Company’s exposure to any individual corporate
entity is limited by policy. Deposits may exceed federally insured limits, and the Company is exposed to credit risk on deposits in the
event of default by the financial institutions to the extent account balances exceed the amount insured by the Federal Deposit Insurance
Corporation (FDIC). The Company closely monitors events involving limited liquidity, defaults, non-performance or other adverse developments
that affect financial institutions or other companies in the financial services industry or the financial services industry generally,
including Silicon Valley Bank. On March 10, 2023, Silicon Valley Bank (“SVB”), where the Company maintained accounts with
a cash balance of less than 6% of the Company’s total cash, cash equivalents and marketable securities, was closed by the California
Department of Financial Protection and Innovation and the FDIC was appointed as receiver. On March 12, 2023, the U.S. Department of the
Treasury, Federal Reserve Board, and FDIC released a joint statement announcing that the FDIC would complete its resolution of SVB in
a manner that fully protected all depositors at SVB and that depositors would have access to all of their money starting March 13, 2023.
On March 26, 2023, it was announced that First-Citizens Bank & Trust Company would assume all of SVB’s deposits and loans as
of March 27, 2023. During the periods presented, the Company has not experienced any losses on its deposits of cash, cash equivalents
or marketable securities.
|
Cash and Cash Equivalents |
Cash
and Cash Equivalents
Cash
and cash equivalents include cash on hand, money market instruments, and other highly liquid investments with original maturities of
three months or less from the date of purchase. Accrued interest receivable on money market instruments, included in other current assets, was less
than $0.1
million as of March 31, 2024, and December 31,
2023.
|
Restricted Cash |
Restricted
Cash
Restricted
cash primarily consists of cash that the Company is obligated to maintain in accordance with contractual obligations. The Company’s
restricted cash was $0.6 million and $0.7 million as of March 31, 2024, and December 31, 2023, respectively.
|
Investments |
Investments
Our
investments may include, at any time, a diversified portfolio of cash equivalents and short-and long-term investments in a variety of
high-quality securities, including money market funds, U.S. treasury and U.S. government agency securities, corporate notes and bonds,
commercial paper, non-U.S. government agency securities, and municipal notes. As of March 31, 2024, and December 31, 2023, the Company had no short-term investments.
Amortized
cost of U.S. treasury securities and marketable debt securities are based on the Company’s purchase price adjusted for accrual
of discount, or amortization of premium, and recognition of impairment charges, if any. The amortized cost of securities the Company
purchases at a discount or premium will equal the face or par value at maturity or the call date, if applicable. Stated interest on investments
is reported as income when earned and is adjusted for amortization or accretion of any premium or discount.
The
Company segments its portfolio based on the underlying risk profiles of the securities and has a zero-loss expectation for U.S. treasury
and U.S. government agency securities. The Company regularly reviews the securities using the probability of default method and analyzes
the unrealized loss positions and evaluates the current expected credit loss by considering factors such as credit ratings, issuer-specific
factors, current economic conditions, and reasonable and supportable forecasts. The Company did not have any material expected credit
losses on investments or material expected credit losses on accrued interest related to investments during the three months ended March
31, 2024, or year ended December 31, 2023.
|
Fair Value Measurements |
Fair
Value Measurements
Financial
instruments consist of cash and cash equivalents, restricted cash, investments, accounts receivable, and accounts payable.
The
Company measures certain financial assets and liabilities at fair value on a recurring basis. General accounting principles for fair
value measurement establishes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value.
The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets and liabilities (“Level
1”) and the lowest priority to unobservable inputs (“Level 3”). The three levels of the fair value hierarchy are described
below:
Level
1: |
|
Values
are based on unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets
or liabilities. |
|
|
|
Level
2: |
|
Values
are based on quoted prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets
that are not active, or other model-based valuation techniques for which all significant assumptions are observable in the market. |
|
|
|
Level
3: |
|
Values
are generated from model-based techniques that use significant assumptions not observable in the market. |
As
of March 31, 2024, and December 31, 2023, financial assets classified as Level 2 consisted of money market funds. The Company reviews
trading activity and pricing for these investments as of the measurement date. When sufficient quoted pricing for identical securities
is not available, the Company uses market pricing and other observable market inputs for similar securities. These inputs either represent
quoted prices for similar assets in active markets or have been derived from observable market data. This approach results in the Level
2 classification of these securities within the fair value hierarchy.
|
Accounts Receivable, Contract Assets, and Allowance for Credit Losses |
Accounts
Receivable, Contract Assets, and Allowance for Credit Losses
Accounts
receivable primarily include amounts due from hospitals and distributors for acquisition of magnetic systems, associated disposable device
sales and service contracts, net of allowances for expected credit losses. Credit is granted on a limited basis, with balances due generally
within 30 days of billing. Contract assets primarily represent the difference between the revenue that was earned but not billed on service
contracts and revenue from system contracts that was recognized based on the relative selling price of the related performance obligations
and the contractual billing terms in the arrangements. The Company reports accounts receivable and contract
assets net of an allowance for expected credit losses in accordance with Accounting Standards Codification Topic 326, Financial Instruments
– Credit Losses (“ASC 326”). The provision for credit loss
is based upon management’s assessment of historical and expected net collections considering business and economic conditions and
other collection indicators. We assess collectability by reviewing the accounts receivable aging schedule on an aggregated basis where
similar characteristics exist and on an individual basis when we identify specific customers with known disputes or collectability issues.
Amounts deemed uncollectible are recorded as an allowance for expected credit losses.
|
Revenue and Costs of Revenue |
Revenue
and Costs of Revenue
The
Company accounts for revenue in accordance with Accounting Standards Codification Topic 606 (“ASC 606”), Revenue from
Contracts with Customers.
We
generate revenue from the initial capital sales of systems as well as recurring revenue from the sale of our proprietary disposable devices,
from royalties paid to the Company on the sale of various devices as provided by co-development and co-placement arrangements, and from
other recurring revenue including ongoing software updates and service contracts.
We
account for a contract with a customer when there is a legally enforceable contract between the Company and the customer, the rights
of the parties are identified, the contract has commercial substance, and collectability of the contract consideration is probable. We
record our revenue based on consideration specified in the contract with each customer, net of any taxes collected from customers that
are remitted to government authorities.
For
contracts containing multiple products and services, the Company accounts for individual products and services as separate performance
obligations if they are distinct, which is if a product or service is separately identifiable from other items in the bundled package,
and if a customer can benefit from it on its own or with other resources that are readily available to the customer. The Company recognizes
revenues as the performance obligations are satisfied by transferring control of the product or service to a customer.
For
arrangements with multiple performance obligations, revenue is allocated to each performance obligation based on its relative standalone
selling price. Standalone selling prices are based on observable prices at which the Company separately sells the products or services.
If a standalone selling price is not directly observable, then the Company estimates the standalone selling price considering market
conditions and entity-specific factors including, but not limited to, features and functionality of the products and services and market
conditions. The Company regularly reviews standalone selling prices and updates these estimates if necessary.
Our
revenue recognition policy affects the following revenue streams in our business as follows:
Systems:
Contracts
related to the sale of systems typically contain separate obligations for the delivery of system(s), installation, service-type warranty,
and an implied obligation to provide software enhancements if and when available for one year following installation. Revenue is recognized
when the Company transfers control to the customer, which is generally at the point when acceptance occurs that indicates customer acknowledgment
of delivery or installation, depending on the terms of the arrangement. Revenue from service-type warranties and the implied obligation
to deliver software enhancements if and when available is included in Other Recurring Revenue and is recognized ratably typically over
the first year following installation of the system as the customer receives the service-type warranty and right to software updates
throughout the period. The Company’s system contracts generally do not provide a right of return. Systems are generally covered
by a one-year service-type warranty or a one-year assurance-type warranty. Assurance-type warranty costs were less than $0.1 million
for the three months ended March 31, 2024, and 2023. Revenue from system delivery and installation represented 38% and 28% of revenue
for the three months ended March 31, 2024, and 2023, respectively.
Disposables:
Revenue
from sales of disposable products is recognized when control is transferred to the customers, which generally occurs at the time of shipment,
but can also occur at the time of delivery depending on the customer arrangement. Disposable products are covered by an assurance type
warranty that provides for the return of defective products. Warranty costs were not material for the three months ended March 31, 2024,
and 2023. Disposable revenue represented 21% and 24% of revenue for the three months ended March 31, 2024, and 2023, respectively.
Royalty:
The
Company receives royalties on the sale of various devices as provided by co-development and co-placement arrangements with various manufacturers.
Royalty revenue represented less than 1% of revenue for the three months ended March 31, 2024, and 2023.
Other
Recurring Revenue:
Other
recurring revenue includes revenue from product maintenance plans, service-type warranties, other post warranty maintenance, and the
implied obligation to provide software enhancements if and when available for a specified period, typically one year following installation
of our systems. Revenue from services and software enhancements, service-type warranties, and the implied obligation to provide software
enhancements are deferred and amortized over the service or update period, which is typically one year. Revenue related to services performed
on a time-and-materials basis is recognized when performed. Other recurring revenue represented 41% and 48% of revenue for the three
months ended March 31, 2024, and 2023, respectively.
The
following table summarizes the Company’s revenue for systems, disposables, and service and accessories for the three months ended
March 31, 2024, and 2023 (in thousands):
Schedule of Revenue Disaggregated by Type
| |
2024 | | |
2023 | |
| |
Three Months Ended March 31, | |
| |
2024 | | |
2023 | |
Systems | |
$ | 2,612 | | |
$ | 1,821 | |
Disposables, service and accessories | |
| 4,268 | | |
| 4,727 | |
Total revenue | |
$ | 6,880 | | |
$ | 6,548 | |
Transaction
price allocated to remaining performance obligations relates to amounts allocated to products and services for which the revenue has
not yet been recognized. A significant portion of this amount relates to the Company’s systems contracts and obligations that will
be recognized as revenue in future periods. These obligations are generally satisfied within two years after contract inception but may
occasionally extend longer. Transaction price representing revenue to be earned on remaining performance obligations on system contracts
was approximately $11.9 million as of March 31, 2024. Performance obligations arising from contracts for disposables and service are
generally expected to be satisfied within one year after entering into the contract.
The
following table summarizes the Company’s contract assets and liabilities (in thousands):
Summary of Contract Assets and Liabilities
| |
March 31, 2024 | | |
December 31, 2023 | |
Contract Assets - unbilled receivables | |
$ | 77 | | |
$ | 72 | |
| |
| | | |
| | |
Customer deposits | |
$ | 1,850 | | |
$ | 2,105 | |
Product shipped, revenue deferred | |
| 1,509 | | |
| 1,413 | |
Deferred service and license fees | |
| 4,160 | | |
| 4,776 | |
Total deferred revenue | |
$ | 7,519 | | |
$ | 8,294 | |
Less: Long-term deferred revenue | |
| (1,581 | ) | |
| (1,637 | ) |
Total current deferred revenue | |
$ | 5,938 | | |
$ | 6,657 | |
The
Company invoices its customers based on the billing schedules in its sales arrangements. Contract assets primarily represent the difference
between the revenue that was earned but not billed on service contracts and revenue from system contracts that was recognized based on
the relative selling price of the related performance obligations and the contractual billing terms in the arrangements. Customer deposits
primarily relate to future system sales but can also include deposits on disposable sales. Deferred revenue is primarily related to service
contracts, for which the service fees are billed up-front, generally quarterly or annually, and for amounts billed in advance for system
contracts for which some performance obligations remain outstanding. For service contracts, the associated deferred revenue is generally
recognized ratably over the service period. For system contracts, the associated deferred revenue is recognized when the remaining performance
obligations are satisfied. The Company did not have any impairment losses on its contract assets for the periods presented.
Revenue
recognized for the three months ended March 31, 2024, and 2023, that was included in the deferred revenue balance at the beginning of
each reporting period was $3.0 million.
|
Assets Recognized from the Costs to Obtain a Contract with a Customer |
Assets
Recognized from the Costs to Obtain a Contract with a Customer
The
Company has determined that sales incentive programs for the Company’s sales team meet the requirements to be capitalized as the
Company expects to generate future economic benefits from the related revenue generating contracts after the initial capital sales transaction.
The costs capitalized as contract acquisition costs included in prepaid expenses and other assets, in the Company’s balance sheet
were $0.1 million as of March 31, 2024, and December 31, 2023. The Company did not incur any impairment losses during any of the periods
presented.
Costs
of systems revenue include direct product costs, installation labor and other costs including estimated assurance-type warranty costs,
and initial training costs, when applicable. These costs are recognized at the time of sale. Costs of disposable revenue include direct
product costs and estimated warranty costs and are recognized at the time of sale. Cost of revenue from services and license fees are
recognized when incurred.
|
Leasing Arrangements |
Leasing
Arrangements
A
lease is defined as a contract, or part of a contract, that conveys the right to control the use of identified property, plant or equipment
for a period of time in exchange for consideration. The Company accounts for leases in accordance with Accounting Standards Update No.
2016-02 “Leases” (Topic 842) and all subsequent ASUs that modified Topic 842 (“ASC 842”). The Company determines
if an arrangement contains a lease at inception.
The
Company leases its facilities under operating leases. In accordance with ASC 842, operating lease agreements are recognized on the balance
sheet as a right-of-use (“ROU”) asset and a corresponding lease liability. These leases generally do not have significant
rent escalation holidays, concessions, leasehold improvement incentives, or other build-out clauses. Further, the leases do not contain
contingent rent provisions. Many of our leases include both lease (i.e., fixed payments including rent, taxes, and insurance costs) and
non-lease components (i.e., common-area or other maintenance costs) which are accounted for as a single lease component as we have elected
the practical expedient to group lease and non-lease components for all leases.
The
Company’s lease agreements often include one or more options to renew at the Company’s discretion. If at lease inception,
the Company considers the exercising of a renewal option to be reasonably certain, the Company will include the extended term in the
calculation of the ROU asset and lease liability. The Company elected not to include short-term leases (i.e., leases with initial terms
of twelve months or less) on the balance sheet.
The
calculated amounts of the ROU assets and lease liabilities are impacted by the length of the lease term and the discount rate used to
calculate the present value of the minimum lease payments. ASC 842 requires the use of the discount rate implicit in the lease whenever
this rate is readily determinable. As this rate is rarely determinable, the Company utilizes its incremental borrowing rate at lease
inception.
|
Stock-Based Compensation |
Stock-Based
Compensation
The
Company accounts for its grants of stock options, non-qualified stock options, stock appreciation rights, restricted shares,
restricted stock units and for its employee stock purchase plan in accordance with the provisions of general accounting principles
for share-based payments. These accounting principles require the determination of the fair value of the stock-based compensation at
the grant date and the recognition of the related expense over the period in which the stock-based compensation vests.
For
time-based awards, the Company utilizes the Black-Scholes valuation model to determine the fair value of stock options and stock
appreciation rights at the date of grant. The weighted average assumptions and fair value for options granted during the three
months ended March 31, 2024, were 1) expected dividend rate of 0%;
2) expected volatility of 76%
based on the Company’s historical volatility; 3) risk-free interest rate based on the Treasury yield on the date of grant; and
4) expected term of 6.25
years. The resulting compensation expense is recognized over the requisite service period, which is generally four years. Restricted
shares and units granted to employees and non-employee directors are valued at the fair market value at the date of grant. The
Company amortizes the fair market value to expense over the service period, which is generally four years except for grants to directors which are generally earned over a period of six months. If the shares are subject to performance objectives, the
resulting compensation expense is amortized over the anticipated vesting period and is subject to adjustment based on the actual
achievement of objectives.
For
market-based awards, stock-based compensation expense is recognized over the minimum service period regardless of whether or not the
market target is probable of being achieved. The fair value of such awards is estimated on the grant date using Monte Carlo simulations.
Shares
purchased by employees under the 2022 Employee Stock Purchase Plans are considered to be non-compensatory.
|
Net Loss per Common Share |
Net
Loss per Common Share
Basic
earnings (loss) per common share is computed by dividing the net earnings (loss) for the period by the weighted average number of common
shares outstanding during the period. In periods where there is net income, we apply the two-class method to calculate basic and diluted
net income (loss) per share of common stock, as our convertible preferred stock is a participating security. The two-class method is
an earnings allocation formula that treats a participating security as having rights to earnings that otherwise would have been available
to common stockholders. In periods where there is a net loss, the two-class method of computing earnings per share does not apply as
our convertible preferred stock does not contractually participate in our losses. We compute diluted net income (loss) per common share
using net income (loss) as the “control number” in determining whether potential common shares are dilutive, after giving
consideration to all potentially dilutive common shares, including stock options, warrants, unvested restricted stock units outstanding
during the period and potential issuance of stock upon the conversion of our convertible preferred stock issued and outstanding during
the period, except where the effect of such securities would be antidilutive.
The
following table sets forth the computation of basic and diluted EPS (in thousands except for share and per share amounts):
Schedule
of Computation of Basic and Diluted Earnings Per Share
| |
2024 | | |
2023 | |
| |
Three Months Ended March 31, | |
| |
2024 | | |
2023 | |
Net loss | |
$ | (4,507 | ) | |
$ | (5,347 | ) |
Cumulative dividend on convertible preferred stock | |
| (331 | ) | |
| (331 | ) |
Net loss attributable to common stockholders | |
$ | (4,838 | ) | |
$ | (5,678 | ) |
| |
| | | |
| | |
Weighted average number of common shares and equivalents: | |
| 83,476,498 | | |
| 76,500,965 | |
Basic EPS | |
$ | (0.06 | ) | |
$ | (0.07 | ) |
Diluted EPS | |
$ | (0.06 | ) | |
$ | (0.07 | ) |
The
Company did not include any portion of unearned restricted shares, outstanding options, stock appreciation rights, warrants or convertible
preferred stock in the calculation of diluted loss per common share because all such securities are anti-dilutive for all periods presented.
The application of the two-class method of computing earnings per share under general accounting principles for participating securities
is not applicable during these periods because those securities do not contractually participate in its losses.
As
of March 31, 2024, the Company had 3,470,733 shares of common stock issuable upon the exercise of outstanding options and stock appreciation
rights at a weighted average exercise price of $3.92 per share, 48,885,547 shares of our common stock issuable upon conversion of our
Series A Convertible Preferred Stock and 1,741,741 shares of unvested restricted share units. The Company had no unearned restricted
shares outstanding as of March 31, 2024.
|
Recently Issued Accounting Pronouncements |
Recently
Issued Accounting Pronouncements
In
June 2016, the FASB issued ASU 2016-13, “Financial Instruments-Credit Losses (Topic 326), Measurement of Credit Losses on Financial
Instruments” and also issued subsequent amendments to the initial guidance under ASU 2018-19, ASU 2019-04 and ASU 2019-05. The
standard modifies the measurement approach for credit losses on financial instruments, including trade receivables, from an incurred
loss method to a current expected credit loss method, otherwise known as “CECL.” The standard requires the measurement of
expected credit losses to be based on relevant information, including historical experience, current conditions and a forecast that is
supportable. The Company adopted the standard in the first quarter of 2023. The impact to the Company’s financial results was immaterial.
In
December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”),
which requires enhanced income tax disclosures, primarily related to the effective tax rate reconciliation and income taxes paid. The
Company does not expect a significant impact on its income tax disclosures upon adoption of the ASU which will be effective in the Company’s
year ending December 31, 2025.
|
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v3.24.1.1.u2
Summary of Significant Accounting Policies (Tables)
|
3 Months Ended |
Mar. 31, 2024 |
Accounting Policies [Abstract] |
|
Schedule of Revenue Disaggregated by Type |
The
following table summarizes the Company’s revenue for systems, disposables, and service and accessories for the three months ended
March 31, 2024, and 2023 (in thousands):
Schedule of Revenue Disaggregated by Type
| |
2024 | | |
2023 | |
| |
Three Months Ended March 31, | |
| |
2024 | | |
2023 | |
Systems | |
$ | 2,612 | | |
$ | 1,821 | |
Disposables, service and accessories | |
| 4,268 | | |
| 4,727 | |
Total revenue | |
$ | 6,880 | | |
$ | 6,548 | |
|
Summary of Contract Assets and Liabilities |
The
following table summarizes the Company’s contract assets and liabilities (in thousands):
Summary of Contract Assets and Liabilities
| |
March 31, 2024 | | |
December 31, 2023 | |
Contract Assets - unbilled receivables | |
$ | 77 | | |
$ | 72 | |
| |
| | | |
| | |
Customer deposits | |
$ | 1,850 | | |
$ | 2,105 | |
Product shipped, revenue deferred | |
| 1,509 | | |
| 1,413 | |
Deferred service and license fees | |
| 4,160 | | |
| 4,776 | |
Total deferred revenue | |
$ | 7,519 | | |
$ | 8,294 | |
Less: Long-term deferred revenue | |
| (1,581 | ) | |
| (1,637 | ) |
Total current deferred revenue | |
$ | 5,938 | | |
$ | 6,657 | |
|
Schedule of Computation of Basic and Diluted Earnings Per Share |
The
following table sets forth the computation of basic and diluted EPS (in thousands except for share and per share amounts):
Schedule
of Computation of Basic and Diluted Earnings Per Share
| |
2024 | | |
2023 | |
| |
Three Months Ended March 31, | |
| |
2024 | | |
2023 | |
Net loss | |
$ | (4,507 | ) | |
$ | (5,347 | ) |
Cumulative dividend on convertible preferred stock | |
| (331 | ) | |
| (331 | ) |
Net loss attributable to common stockholders | |
$ | (4,838 | ) | |
$ | (5,678 | ) |
| |
| | | |
| | |
Weighted average number of common shares and equivalents: | |
| 83,476,498 | | |
| 76,500,965 | |
Basic EPS | |
$ | (0.06 | ) | |
$ | (0.07 | ) |
Diluted EPS | |
$ | (0.06 | ) | |
$ | (0.07 | ) |
|
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v3.24.1.1.u2
Financial Instruments (Tables)
|
3 Months Ended |
Mar. 31, 2024 |
Investments, All Other Investments [Abstract] |
|
Schedule of Cash and Cash Equivalents, Restricted Cash and Investments |
The
following tables summarize the Company’s cash and fair value by significant category reported as cash and cash equivalents and
restricted cash as of March 31, 2024, and December 31, 2023:
Schedule
of Cash and Cash Equivalents, Restricted Cash and Investments
| |
March 31, 2024 | |
| |
Valuation | | |
Reported as: | |
(in thousands) | |
Amortized
Cost | | |
Gross
Unrealized
Gains | | |
Gross
Unrealized
Losses | | |
Fair
Value | | |
Cash and
Cash Equivalents | | |
Restricted
Cash-
current | | |
Short-
term
Investments | | |
Restricted
Cash | |
Cash | |
$ | 1,662 | | |
$ | - | | |
$ | - | | |
$ | 1,662 | | |
$ | 1,662 | | |
$ | - | | |
$ | - | | |
$ | - | |
Level 2 | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Money market funds | |
| 16,584 | | |
| - | | |
| - | | |
| 16,584 | | |
| 15,971 | | |
| 525 | | |
| - | | |
| 88 | |
Subtotal | |
| 16,584 | | |
| - | | |
| - | | |
| 16,584 | | |
| 15,971 | | |
| 525 | | |
| - | | |
| 88 | |
Total assets measured at fair value | |
$ | 18,246 | | |
$ | - | | |
$ | - | | |
$ | 18,246 | | |
$ | 17,633 | | |
$ | 525 | | |
$ | - | | |
$ | 88 | |
| |
December 31, 2023 | |
| |
Valuation | | |
Reported as: | |
(in thousands) | |
Amortized
Cost | | |
Gross
Unrealized
Gains | | |
Gross
Unrealized
Losses | | |
Fair
Value | | |
Cash and
Cash
Equivalents | | |
Restricted
Cash-
current | | |
Short-
term
Investments | | |
Restricted
Cash | |
Cash | |
$ | 2,122 | | |
$ | - | | |
$ | - | | |
$ | 2,122 | | |
$ | 2,122 | | |
$ | - | | |
$ | - | | |
$ | - | |
Level 2 | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Money market funds | |
| 18,440 | | |
| - | | |
| - | | |
| 18,440 | | |
| 17,696 | | |
| 525 | | |
| - | | |
| 219 | |
Subtotal | |
| 18,440 | | |
| - | | |
| - | | |
| 18,440 | | |
| 17,696 | | |
| 525 | | |
| - | | |
| 219 | |
Total assets measured at fair value | |
$ | 20,562 | | |
$ | - | | |
$ | - | | |
$ | 20,562 | | |
$ | 19,818 | | |
$ | 525 | | |
$ | - | | |
$ | 219 | |
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v3.24.1.1.u2
Inventories (Tables)
|
3 Months Ended |
Mar. 31, 2024 |
Inventory Disclosure [Abstract] |
|
Schedule of Inventories |
Inventories
consist of the following (in thousands):
Schedule of Inventories
| |
March 31, 2024 | | |
December 31, 2023 | |
Raw materials | |
$ | 6,507 | | |
$ | 5,918 | |
Work in process | |
| 457 | | |
| 1,034 | |
Finished goods | |
| 3,255 | | |
| 3,413 | |
Reserve for excess and obsolescence | |
| (1,967 | ) | |
| (1,939 | ) |
Total inventory | |
$ | 8,252 | | |
$ | 8,426 | |
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v3.24.1.1.u2
Prepaid Expenses and Other Assets (Tables)
|
3 Months Ended |
Mar. 31, 2024 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] |
|
Schedule of Prepaid Expenses and Other Assets |
Prepaid
expenses and other assets consist of the following (in thousands):
Schedule of Prepaid Expenses and Other Assets
| |
March 31, 2024 | | |
December 31, 2023 | |
Prepaid expenses | |
$ | 465 | | |
$ | 181 | |
Prepaid commissions | |
| 92 | | |
| 110 | |
Deposits | |
| 284 | | |
| 424 | |
Other assets | |
| 120 | | |
| 98 | |
Total prepaid expenses and other assets | |
| 961 | | |
| 813 | |
Less: Noncurrent prepaid expenses and other assets | |
| (116 | ) | |
| (137 | ) |
Total current prepaid expenses and other assets | |
$ | 845 | | |
$ | 676 | |
|
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v3.24.1.1.u2
Property and Equipment (Tables)
|
3 Months Ended |
Mar. 31, 2024 |
Property, Plant and Equipment [Abstract] |
|
Schedule of Property and Equipment |
Property
and Equipment consist of the following (in thousands):
Schedule of Property and Equipment
| |
March 31, 2024 | | |
December 31, 2023 | |
Equipment | |
$ | 4,269 | | |
$ | 4,269 | |
Leasehold improvements | |
| 2,911 | | |
| 2,911 | |
Gross property and equipment | |
| 7,180 | | |
| 7,180 | |
Less: Accumulated depreciation | |
| (4,016 | ) | |
| (3,876 | ) |
Net property and equipment | |
$ | 3,164 | | |
$ | 3,304 | |
|
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v3.24.1.1.u2
Leases (Tables)
|
3 Months Ended |
Mar. 31, 2024 |
Leases |
|
Schedule of Lease Costs and Other Lease Information |
The
following table represents lease costs and other lease information (in thousands):
Schedule of Lease Costs and Other Lease Information
| |
2024 | | |
2023 | |
| |
Three Months Ended March 31, | |
| |
2024 | | |
2023 | |
Operating lease cost | |
$ | 227 | | |
$ | 227 | |
Short-term lease cost | |
| 3 | | |
| 4 | |
Total net lease cost | |
$ | 230 | | |
$ | 231 | |
| |
| | | |
| | |
Cash paid within operating cash flows | |
$ | 258 | | |
$ | 242 | |
|
Schedule of Future Minimum Operating Lease Payments |
Future
minimum payments for operating leases with initial or remaining terms of one year or more as of March 31, 2024, were as follows (in thousands):
Schedule of Future Minimum Operating Lease Payments
| |
March 31, 2024 | |
2024 | |
$ | 674 | |
2025 | |
| 919 | |
2026 | |
| 935 | |
2027 | |
| 956 | |
2028 | |
| 976 | |
2029 and thereafter | |
| 3,054 | |
Total lease payments | |
| 7,514 | |
Less: Interest | |
| (2,126 | ) |
Present value of lease liabilities | |
$ | 5,388 | |
|
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v3.24.1.1.u2
Accrued Liabilities (Tables)
|
3 Months Ended |
Mar. 31, 2024 |
Payables and Accruals [Abstract] |
|
Schedule of Accrued Liabilities |
Accrued
liabilities consist of the following (in thousands):
Schedule of Accrued Liabilities
| |
March 31, 2024 | | |
December 31, 2023 | |
Accrued salaries, bonus, and benefits | |
$ | 1,210 | | |
$ | 1,222 | |
Accrued licenses and maintenance fees | |
| 484 | | |
| 484 | |
Accrued warranties | |
| 90 | | |
| 107 | |
Accrued professional services | |
| 109 | | |
| 138 | |
Accrued investigational sites | |
| 182 | | |
| - | |
Deferred contract obligation | |
| 1,045 | | |
| 1,045 | |
Other | |
| 87 | | |
| 19 | |
Total accrued liabilities | |
| 3,207 | | |
| 3,015 | |
Less: Long term accrued liabilities | |
| (43 | ) | |
| (43 | ) |
Total current accrued liabilities | |
$ | 3,164 | | |
$ | 2,972 | |
|
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v3.24.1.1.u2
Convertible Preferred Stock and Stockholders’ Equity (Tables)
|
3 Months Ended |
Mar. 31, 2024 |
Equity [Abstract] |
|
Summary of Performance Award And Market Capitalization Milestones |
Summary of Performance Award And Market Capitalization Milestones
Tranche # | |
No. of Shares Subject to PSU | | |
Market Capitalization Milestones(1) | |
1 | |
| 1,000,000 | | |
$ | 1,000,000,000 | |
2 | |
| 1,500,000 | | |
$ | 1,500,000,000 | |
3 | |
| 1,500,000 | | |
$ | 2,000,000,000 | |
4 | |
| 2,000,000 | | |
$ | 2,500,000,000 | |
5 | |
| 1,000,000 | | |
$ | 3,000,000,000 | |
6 | |
| 1,000,000 | | |
$ | 3,500,000,000 | |
7 | |
| 1,000,000 | | |
$ | 4,000,000,000 | |
8 | |
| 2,000,000 | | |
$ | 4,500,000,000 | |
9 | |
| 1,000,000 | | |
$ | 5,000,000,000 | |
10 | |
| 1,000,000 | | |
$ | 5,500,000,000 | |
Total: | |
| 13,000,000 | | |
| | |
|
Summary of Option and Stock Appreciation Rights Activity |
Summary of Option and Stock Appreciation Rights Activity
| |
Number of Options/SARs | | |
Range of Exercise Price | | |
Weighted Average Exercise Price per Share | |
Outstanding, December 31, 2023 | |
| 3,650,115 | | |
| $0.74 - $9.87 | | |
$ | 3.93 | |
Granted | |
| 20,000 | | |
| $2.80 | | |
$ | 2.80 | |
Exercised | |
| (9,550 | ) | |
| $0.74 - $2.03 | | |
$ | 0.80 | |
Forfeited | |
| (189,832 | ) | |
| $0.74 - $6.96 | | |
$ | 4.03 | |
Outstanding, March 31, 2024 | |
| 3,470,733 | | |
| $0.74 - $9.87 | | |
$ | 3.92 | |
|
Summary of Restricted Stock Unit Activity |
A
summary of the restricted stock unit activity for the three-month period ended March 31, 2024, is as follows:
Summary of Restricted Stock Unit Activity
| |
Number of Restricted Stock Units | | |
Weighted Average Grant Date Fair Value per Unit | |
Outstanding, December 31, 2023 | |
| 1,502,131 | | |
$ | 3.94 | |
Granted | |
| 389,610 | | |
$ | 1.54 | |
Vested | |
| (150,000 | ) | |
$ | 1.19 | |
Outstanding, March 31, 2024 | |
| 1,741,741 | | |
$ | 3.64 | |
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v3.24.1.1.u2
Product Warranty Provisions (Tables)
|
3 Months Ended |
Mar. 31, 2024 |
Guarantees and Product Warranties [Abstract] |
|
Schedule of Accrued Warranty |
Accrued
warranty, which is included in other accrued liabilities, consists of the following (in thousands):
Schedule
of Accrued Warranty
| |
March 31, 2024 | | |
December 31, 2023 | |
Warranty accrual, beginning of the fiscal period | |
$ | 107 | | |
$ | 163 | |
Accrual adjustment for product warranty | |
| (1 | ) | |
| 547 | |
Payments made | |
| (16 | ) | |
| (603 | ) |
Warranty accrual, end of the fiscal period | |
$ | 90 | | |
$ | 107 | |
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v3.24.1.1.u2
Summary of Contract Assets and Liabilities (Details) - USD ($) $ in Thousands |
Mar. 31, 2024 |
Dec. 31, 2023 |
Product Information [Line Items] |
|
|
Contract Assets - unbilled receivables |
$ 77
|
$ 72
|
Total deferred revenue |
7,519
|
8,294
|
Less: Long-term deferred revenue |
(1,581)
|
(1,637)
|
Total current deferred revenue |
5,938
|
6,657
|
Customer Deposits [Member] |
|
|
Product Information [Line Items] |
|
|
Total deferred revenue |
1,850
|
2,105
|
Product Shipped Revenue Deferred [Member] |
|
|
Product Information [Line Items] |
|
|
Total deferred revenue |
1,509
|
1,413
|
Deferred Service and License Fees [Member] |
|
|
Product Information [Line Items] |
|
|
Total deferred revenue |
$ 4,160
|
$ 4,776
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v3.24.1.1.u2
Schedule of Computation of Basic and Diluted Earnings Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands |
3 Months Ended |
Mar. 31, 2024 |
Mar. 31, 2023 |
Accounting Policies [Abstract] |
|
|
Net loss |
$ (4,507)
|
$ (5,347)
|
Cumulative dividend on convertible preferred stock |
(331)
|
(331)
|
Net loss attributable to common stockholders |
$ (4,838)
|
$ (5,678)
|
Weighted average number of common shares and equivalents, basic |
83,476,498
|
76,500,965
|
Weighted average number of common shares and equivalents, diluted |
83,476,498
|
76,500,965
|
Basic EPS |
$ (0.06)
|
$ (0.07)
|
Diluted EPS |
$ (0.06)
|
$ (0.07)
|
X |
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v3.24.1.1.u2
Summary of Significant Accounting Policies (Details Narrative) - USD ($) $ / shares in Units, $ in Millions |
3 Months Ended |
12 Months Ended |
Mar. 31, 2024 |
Mar. 31, 2023 |
Dec. 31, 2023 |
Product Information [Line Items] |
|
|
|
Restricted cash |
$ 0.6
|
|
$ 0.7
|
Short-term investments |
|
|
|
Expected credit loss on investments or accrued interest, description |
The Company did not have any material expected credit
losses on investments or material expected credit losses on accrued interest related to investments during the three months ended March
31, 2024, or year ended December 31, 2023.
|
|
The Company did not have any material expected credit
losses on investments or material expected credit losses on accrued interest related to investments during the three months ended March
31, 2024, or year ended December 31, 2023.
|
Remaining performance obligations |
$ 11.9
|
|
|
Contract with customer liability revenue recognized |
3.0
|
$ 3.0
|
|
Capitalized contract cost |
$ 0.1
|
|
$ 0.1
|
Expected dividend rate |
0.00%
|
|
|
Expected volatility |
76.00%
|
|
|
Expected term |
6 years 3 months
|
|
|
Series A Convertible Preferred Stock [Member] |
|
|
|
Product Information [Line Items] |
|
|
|
Potential common shares excluded from diluted earnings per share |
48,885,547
|
|
|
Stock Options and Stock Appreciation Rights [Member] |
|
|
|
Product Information [Line Items] |
|
|
|
Potential common shares excluded from diluted earnings per share |
3,470,733
|
|
|
Weighted average exercise price |
$ 3.92
|
|
|
Restricted Stock [Member] |
|
|
|
Product Information [Line Items] |
|
|
|
Potential common shares excluded from diluted earnings per share |
1,741,741
|
|
|
Unearned Restricted Shares [Member] |
|
|
|
Product Information [Line Items] |
|
|
|
Potential common shares excluded from diluted earnings per share |
0
|
|
|
Revenue From System Delivery and Installation [Member] | Product Concentration Risk [Member] |
|
|
|
Product Information [Line Items] |
|
|
|
Concentration risk percentage |
38.00%
|
28.00%
|
|
Disposable revenue [Member] | Product Concentration Risk [Member] |
|
|
|
Product Information [Line Items] |
|
|
|
Concentration risk percentage |
21.00%
|
24.00%
|
|
Royalty Revenue [Member] | Product Concentration Risk [Member] |
|
|
|
Product Information [Line Items] |
|
|
|
Concentration risk percentage |
1.00%
|
1.00%
|
|
Other Recurring Revenue [Member] | Product Concentration Risk [Member] |
|
|
|
Product Information [Line Items] |
|
|
|
Concentration risk percentage |
41.00%
|
48.00%
|
|
Systems [Member] |
|
|
|
Product Information [Line Items] |
|
|
|
Warranty costs |
$ 0.1
|
$ 0.1
|
|
Other Current Assets [Member] | Maximum [Member] |
|
|
|
Product Information [Line Items] |
|
|
|
[custom:AccruedInterestReceivableOnInvestment-0] |
$ 0.1
|
|
$ 0.1
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v3.24.1.1.u2
Schedule of Cash and Cash Equivalents, Restricted Cash and Investments (Details) - USD ($) $ in Thousands |
Mar. 31, 2024 |
Dec. 31, 2023 |
Mar. 31, 2023 |
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
|
Cash and Cash Equivalents |
$ 17,633
|
$ 19,818
|
$ 5,623
|
Restricted Cash- current |
525
|
525
|
525
|
Short-term Investments |
|
|
|
Restricted Cash |
88
|
219
|
$ 612
|
Total assets measured at fair value, Amortized Cost |
18,246
|
20,562
|
|
Total assets measured at fair value, Gross Unrealized Gains |
|
|
|
Total assets measured at fair value, Gross Unrealized Losses |
|
|
|
Total assets measured at fair value, Fair value |
18,246
|
20,562
|
|
Fair Value, Inputs, Level 2 [Member] |
|
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
|
Cash and Cash Equivalents |
15,971
|
17,696
|
|
Restricted Cash- current |
525
|
525
|
|
Short-term Investments |
|
|
|
Restricted Cash |
88
|
219
|
|
Cash and Held to maturity securities, Amortized Cost |
16,584
|
18,440
|
|
Cash and Held to maturity securities, Gross Unrealized Gains |
|
|
|
Cash and Held to maturity securities, Gross Unrealized Losses |
|
|
|
Cash and Held to maturity securities, Fair Value |
16,584
|
18,440
|
|
Cash [Member] |
|
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
|
Cash, Amortized Cost |
1,662
|
2,122
|
|
Cash, Gross Unrealized Gains |
|
|
|
Cash, Gross Unrealized Losses |
|
|
|
Cash, Fair Value |
1,662
|
2,122
|
|
Cash and Cash Equivalents |
1,662
|
2,122
|
|
Restricted Cash- current |
|
|
|
Short-term Investments |
|
|
|
Restricted Cash |
|
|
|
Money Market Funds [Member] | Fair Value, Inputs, Level 2 [Member] |
|
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
|
Cash, Amortized Cost |
16,584
|
18,440
|
|
Cash, Gross Unrealized Gains |
|
|
|
Cash, Gross Unrealized Losses |
|
|
|
Cash, Fair Value |
16,584
|
18,440
|
|
Cash and Cash Equivalents |
15,971
|
17,696
|
|
Restricted Cash- current |
525
|
525
|
|
Short-term Investments |
|
|
|
Restricted Cash |
$ 88
|
$ 219
|
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Schedule of Inventories (Details) - USD ($) $ in Thousands |
Mar. 31, 2024 |
Dec. 31, 2023 |
Inventory Disclosure [Abstract] |
|
|
Raw materials |
$ 6,507
|
$ 5,918
|
Work in process |
457
|
1,034
|
Finished goods |
3,255
|
3,413
|
Reserve for excess and obsolescence |
(1,967)
|
(1,939)
|
Total inventory |
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|
$ 8,426
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Schedule of Property and Equipment (Details) - USD ($) $ in Thousands |
Mar. 31, 2024 |
Dec. 31, 2023 |
Property, Plant and Equipment [Line Items] |
|
|
Gross property and equipment |
$ 7,180
|
$ 7,180
|
Less: Accumulated depreciation |
(4,016)
|
(3,876)
|
Net property and equipment |
3,164
|
3,304
|
Equipment [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Gross property and equipment |
4,269
|
4,269
|
Leasehold Improvements [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Gross property and equipment |
$ 2,911
|
$ 2,911
|
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v3.24.1.1.u2
Schedule of Accrued Liabilities (Details) - USD ($) $ in Thousands |
Mar. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2022 |
Payables and Accruals [Abstract] |
|
|
|
Accrued salaries, bonus, and benefits |
$ 1,210
|
$ 1,222
|
|
Accrued licenses and maintenance fees |
484
|
484
|
|
Accrued warranties |
90
|
107
|
$ 163
|
Accrued professional services |
109
|
138
|
|
Accrued investigational sites |
182
|
|
|
Deferred contract obligation |
1,045
|
1,045
|
|
Other |
87
|
19
|
|
Total accrued liabilities |
3,207
|
3,015
|
|
Less: Long term accrued liabilities |
(43)
|
(43)
|
|
Total current accrued liabilities |
$ 3,164
|
$ 2,972
|
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v3.24.1.1.u2
Summary of Performance Award And Market Capitalization Milestones (Details) - PSU Agreement [Member] - Mr. Fischel [Member]
|
Feb. 23, 2021
USD ($)
shares
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
Number of shares subject to PSU | shares |
13,000,000
|
Market capitalization milestone, amount | $ |
$ 1,000,000,000.0
|
Share-Based Payment Arrangement, Tranche One [Member] |
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
Number of shares subject to PSU | shares |
1,000,000
|
Market capitalization milestone, amount | $ |
$ 1,000,000,000
|
Share-Based Payment Arrangement, Tranche Two [Member] |
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
Number of shares subject to PSU | shares |
1,500,000
|
Market capitalization milestone, amount | $ |
$ 1,500,000,000
|
Share-Based Payment Arrangement, Tranche Three [Member] |
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
Number of shares subject to PSU | shares |
1,500,000
|
Market capitalization milestone, amount | $ |
$ 2,000,000,000
|
ShareBased Compensation Award Tranche Four [Member] |
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
Number of shares subject to PSU | shares |
2,000,000
|
Market capitalization milestone, amount | $ |
$ 2,500,000,000
|
ShareBased Compensation Award Tranche Five [Member] |
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
Number of shares subject to PSU | shares |
1,000,000
|
Market capitalization milestone, amount | $ |
$ 3,000,000,000
|
ShareBased Compensation Award Tranche Six [Member] |
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
Number of shares subject to PSU | shares |
1,000,000
|
Market capitalization milestone, amount | $ |
$ 3,500,000,000
|
ShareBased Compensation Award Tranche Seven [Member] |
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
Number of shares subject to PSU | shares |
1,000,000
|
Market capitalization milestone, amount | $ |
$ 4,000,000,000
|
ShareBased Compensation Award Tranche Eight [Member] |
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
Number of shares subject to PSU | shares |
2,000,000
|
Market capitalization milestone, amount | $ |
$ 4,500,000,000
|
ShareBased Compensation Award Tranche Nine [Member] |
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
Number of shares subject to PSU | shares |
1,000,000
|
Market capitalization milestone, amount | $ |
$ 5,000,000,000
|
ShareBased Compensation Award Tranche Ten [Member] |
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
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1,000,000
|
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$ 5,500,000,000
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v3.24.1.1.u2
Summary of Option and Stock Appreciation Rights Activity (Details) - Equity Option [Member] - Stock Appreciation Rights (SARs) [Member]
|
3 Months Ended |
Mar. 31, 2024
$ / shares
shares
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
Number of Options/SARs, Outstanding, Beginning | shares |
3,650,115
|
Weighted Average Exercise Price per Share, Outstanding, Beginning |
$ 3.93
|
Number of Options/SARs, Granted | shares |
20,000
|
Range of Exercise Price, Granted |
$ 2.80
|
Weighted Average Exercise Price per Share, Granted |
$ 2.80
|
Number of Options/SARs, Exercised | shares |
(9,550)
|
Weighted Average Exercise Price per Share, Exercised |
$ 0.80
|
Number of Options/SARs, Forfeited | shares |
(189,832)
|
Weighted Average Exercise Price per Share, Forfeited |
$ 4.03
|
Number of Options/SARs, Outstanding, Ending | shares |
3,470,733
|
Weighted Average Exercise Price per Share, Outstanding, Ending |
$ 3.92
|
Minimum [Member] |
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
Range of Exercise Price, Outstanding |
0.74
|
Range of Exercise Price, Exercised |
0.74
|
Range of Exercise Price, Forfeited |
0.74
|
Range of Exercise Price, Outstanding, Ending |
0.74
|
Maximum [Member] |
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
Range of Exercise Price, Outstanding |
9.87
|
Range of Exercise Price, Exercised |
2.03
|
Range of Exercise Price, Forfeited |
6.96
|
Range of Exercise Price, Outstanding, Ending |
$ 9.87
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Summary of Restricted Stock Unit Activity (Details) - Restricted Stock Units (RSUs) [Member]
|
3 Months Ended |
Mar. 31, 2024
$ / shares
shares
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Number of Restricted Stock Units, Outstanding, Beginning | shares |
1,502,131
|
Weighted Average Grant Date Fair Value per Unit, Outstanding, Beginning | $ / shares |
$ 3.94
|
Number of Restricted Stock Units, Outstanding, Granted | shares |
389,610
|
Weighted Average Grant Date Fair Value per Unit, Granted | $ / shares |
$ 1.54
|
Number of Restricted Stock Units, Outstanding, Vested | shares |
(150,000)
|
Weighted Average Grant Date Fair Value per Unit, Vested | $ / shares |
$ 1.19
|
Number of Restricted Stock Units, Outstanding, Ending | shares |
1,741,741
|
Weighted Average Grant Date Fair Value per Unit, Outstanding, Ending | $ / shares |
$ 3.64
|
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v3.24.1.1.u2
Convertible Preferred Stock and Stockholders’ Equity (Details Narrative) - USD ($)
|
|
1 Months Ended |
3 Months Ended |
Feb. 23, 2021 |
Sep. 30, 2016 |
Mar. 31, 2024 |
Mar. 31, 2023 |
Class of Stock [Line Items] |
|
|
|
|
Common stock, voting rights |
|
|
The
holders of common stock are entitled to one vote for each share held
|
|
Payments of dividends common stock |
|
|
$ 0
|
|
Stock-based compensation expense |
|
|
2,589,000
|
$ 2,655,000
|
Unrecognized stock-based compensation expense |
|
|
$ 3,000,000.0
|
|
Share based payment arrangement, cost not yet recognized, period |
|
|
4 years
|
|
2012 Stock Incentive Plan [Member] |
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
Stock plan expiration date |
|
|
May 19, 2022
|
|
Stock Award Plans [Member] |
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
Common stock, shares reserved for future grants |
|
|
2,297,196
|
|
PSU Agreement [Member] | Mr. Fischel [Member] |
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
Performance award term |
10 years
|
|
|
|
Number of shares granted |
13,000,000
|
|
|
|
Maximum market capitalization milestone, amount |
$ 1,000,000,000.0
|
|
|
|
Increase in market capitalization milestone, amount |
$ 500,000,000
|
|
|
|
Award vesting rights, description |
Each
tranche represents a portion of the PSUs covering the number of shares outlined in the table above. Each tranche vests upon (i) satisfaction
of the market capitalization milestones and (ii) continued employment as CEO of the Company from the grant date through December 31,
2030. Absent an earlier termination, the PSUs will expire on December 31, 2030. If our CEO ceases employment as CEO of the Company for
any reason including death, disability, termination for cause or without cause (as defined in the award agreement), or if he voluntary
terminates after service as CEO for at least five years, the remaining service period will be waived and he will retain any PSUs that
have vested through the date of termination.
|
|
|
|
Stock-based compensation expense |
|
|
$ 1,800,000
|
1,800,000
|
Unrecognized stock-based compensation expense |
|
|
$ 35,200,000
|
$ 42,400,000
|
PSU Agreement [Member] | Mr. Fischel [Member] | Maximum [Member] |
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
Maximum market capitalization milestone, amount |
$ 5,500,000,000
|
|
|
|
Series A Convertible Preferred Stock [Member] |
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
Sale of stock, number of shares sold |
|
24,000
|
|
|
Preferred stock, par value |
|
$ 0.001
|
|
|
Preferred stock, stated value |
|
1,000
|
|
|
Redemption price per share |
|
$ 0.65
|
|
|
Common stock issuable from warrants |
|
36,923,078
|
|
|
Preferred stock dividend rate |
|
6.00%
|
|
|
Preferred stock redemption, triggering event, percent of common stock sold threshold |
|
50.00%
|
|
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