Stereotaxis, Inc. (STXS) FY 2024 MD&A
This page reproduces the company's own Item 7 MD&A text from the linked SEC filing. It is filer text, not grepcent analysis, scoring, or investment advice.
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The
following discussion and analysis should be read in conjunction with our consolidated financial statements and notes thereto included
in this report on Form 10-K. 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 Item 1A. “Risk Factors,” as well as various impacts related to our previously announced acquisition
of Access Point Technologies EP, 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 impact
of, and our response to the coronavirus (“COVID-19”) pandemic pandemics similar to the coronavirus (“COVID-19”)
pandemic (or COVID-19 resurgences), and statements relating to our recent acquisition of APT including any benefits expected from the
acquisition, potential strategic implications as a result of the acquisition, and the potential for achievement of the regulatory and
commercial milestones that would trigger contingent payments in the transaction. Such statements include, but are not limited to, statements
preceded by, followed by or that otherwise include the words “believes,” “expects,” “anticipates,”
“intends,” “estimates,” “projects,” “can,” “could,” “may,” “will,”
“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 were made. They give our expectations regarding the future but are not guarantees. We undertake
no obligation to update publicly or revise forward-looking statements, whether because 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. We have shared our aspiration and a product strategy to expand the clinical focus of our technology to several additional
endovascular indications including coronary, neuro, and peripheral interventions.
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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 150,000 arrhythmia patients with our robotic technology. Clinical use of our
technology has been documented in over 500 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 GenesisX 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 GenesisX RMN System, the latest generation of the Genesis RMN System, is designed to significantly
enhance the accessibility of Robotic Magnetic Navigation by eliminating the lengthy construction cycle necessary to install prior generation
RMN systems.
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 are actively developing the next generation imaging and collaboration solutions with Synchrony and SynX.
We
pursue arrangements with fluoroscopy system manufacturers to provide such systems in a bundled purchase offer for hospitals establishing
robotic interventional operating rooms. An integrated x-ray system is critical for customer adoption of RMN systems, and when offered
as a bundled purchase offer with the RMN System, may reduce 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 necessary for 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., Europe, and China,
and we are in the process of obtaining necessary registrations for extending our markets in other countries. The GenesisX RMN System,
the latest generation of the Genesis RMN System has received regulatory clearances and approvals in Europe, and we are in the process
of obtaining necessary registrations in the US and other countries, The Niobe System, our prior generation robotic magnetic navigation
system, the Odyssey Solution, Cardiodrive, e-Contact, and various disposable interventional devices, including the Map-iT
family of devices, have received regulatory clearances and approvals in the U.S., Europe, Canada, China, Japan and various other countries.
We have regulatory clearances and approvals that allow us to market the Vdrive and Vdrive Duo Systems with the V-CAS
device in the U.S., Canada, and Europe. We have obtained the CE marking for us to market the Stereotaxis MAGiC catheter in Europe
and are pursuing regulatory approval in the U.S. and various other 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.
Not
all products have and/or require regulatory clearance in all the markets we serve. Please refer to “Regulatory Approval”
in Item 1 for a description of the regulatory clearance, licensing, and/or approvals we currently have or are pursuing.
As
of December 31, 2024, we had approximately $15.2 million of backlog, consisting of outstanding purchase orders and other commitments
for these systems. Of the December 31, 2024 backlog, we expect approximately 70% to be recognized as revenue over the course of 2025.
We had backlog of approximately $14.7 million as of December 31, 2023. There can be no assurance that we will recognize such revenue
in any period or at all because some of our purchase orders and other commitments are subject to contingencies that are outside our control.
These orders and commitments may be revised, modified or canceled, either by their express terms, because of negotiations or by project
changes or delays. In addition, the sales cycle for the robotic magnetic navigation system is lengthy and generally involves construction
or renovation activities at customer sites. Consequently, revenues and/or orders resulting from sales of our robotic magnetic navigation
system can vary significantly from one reporting period to the next.
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We
have strategic relationships with technology leaders and innovators in the global interventional market. Through these strategic relationships
we provide compatibility with our robotic magnetic navigation system, integrated x-ray systems, digital imaging and 3D catheter location
sensing technology, and compatible 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
July 31, 2024, the Company completed its acquisition of all the shares of capital stock of Access Point Technologies EP, Inc., a Minnesota
corporation (“APT”), from APT Holding Company, Inc., a Minnesota corporation. APT, based in Rogers, Minnesota, designs, manufactures,
and commercializes a portfolio of differentiated high-quality diagnostic catheters, branded as Map-iT catheters, used during cardiac
ablation procedures that are commercially available across key global geographies.
The
transaction was concluded pursuant to that certain Share Purchase Agreement, dated May 11, 2024. The transaction consideration included
an upfront payment of 1,486,620 shares of Company common stock issued at closing, as well as additional contingent payments of Company
common stock based upon the achievement of specified product revenue and regulatory approval milestones through September 30, 2029. All
consideration is payable in Stereotaxis common stock.
The
integration with APT provides in-house catheter development, manufacturing expertise and specialized knowledge that will further Stereotaxis’
innovation efforts in developing a broad family of interventional devices navigated by our robots within electrophysiology and across
a range of endovascular procedures.
In
addition to the integration with APT, Stereotaxis has made other advancements in robotically enabled interventional devices. The Stereotaxis
MAGiC catheter, a robotically navigated magnetic ablation catheter designed to perform minimally invasive cardiac ablation procedures,
obtained the CE marking in Europe in the first quarter, 2025, and we are in the process of obtaining necessary approvals in the U.S.
and other countries. We are also currently seeking FDA clearances for other devices including the MAGiC Sweep™ catheter, the first
high-density EP mapping catheter developed to be robotically navigated using Stereotaxis’ Robotic Magnetic Navigation system, and
the EMAGIN 5F catheter guide designed to robotically navigate tortuous venous and arterial vasculature.
Beyond
interventional devices, we continue to drive our broad-based innovation plan with ongoing regulatory and development efforts for our
RMN systems. In the third quarter of 2024, we attained CE Mark for the GenesisX RMN System and are working towards FDA 510(k)
regulatory clearance within the United States. This latest generation of the RMN System is designed to significantly enhance the accessibility
of Robotic Magnetic Navigation by eliminating the lengthy construction cycle necessary to install prior generation RMN systems. In November
2024, the Genesis RMN system, our current generation system, received regulatory approval from China’s National Medical
Products Administration (NMPA), and our partner MicroPort received the regulatory clearances and for their integrated mapping system
and novel ablation catheter making available the most current advances minimally-invasive robotic technology to physicians and patients
in China.
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, tariffs or other trade
restrictions, 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 COVID-19 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.
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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 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 or similar occurrences may 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-pandemic areas, leading to the
performance of fewer procedures in which our disposable products are used. The impact varied widely over time by individual geography.
For instance, in 2022, procedure volumes were challenged by periodic resurgences of COVID-19, ongoing hospital staffing issues and other
factors. In the first quarter of 2023, COVID-19 resurgences in China continued to negatively impact our procedure volumes in that region,
but as infections and hospitalization decreased, we saw a recovery of procedure volumes with no further impacts in the current year.
Significant decreases to our capital or recurring revenues could have a material adverse effect on our business, operating results, and
financial condition. We continue to anticipate periodic disruptions to our manufacturing operations, supply chains, procedures volumes,
service activities, and capital system orders and placements relating to new or ongoing periodic resurgences of pandemic-related issues,
any of which could have a material adverse effect on our business, financial condition, results of operations, or cash flows.
As
a result of the acquisition, we will be managing APT’s ongoing business of manufacturing, commercializing, development and sales
of APT’s catheters and related products and services. The manufacturing process of catheters is complex, highly technical, and
our prior experience in this field is dated. The process can be subject to periodic worldwide supply chain disruptions, including labor
shortages and inflationary pressures, tariffs or other trade restrictions, and logistics delays which make it difficult for us to source
parts and ship our products. We may require a higher level of overhead than currently anticipated. Our ability to successfully manage
this new aspect of our business will depend, in part, upon management’s ability to design and implement strategic initiatives that
address not only the integration of APT into us, but also the increased scope of the combined business with its associated increased
costs and complexity. We are still integrating the businesses and implementing safeguards to minimize any negative impacts on our financial
position, results of operations and cash flows post-acquisition.
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-term 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.
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Critical
Accounting Policies and Estimates
Our
discussion and analysis of our financial condition and results of operations are based on our consolidated financial statements, which
have been prepared in accordance with U.S. generally accepted accounting principles. The preparation of these consolidated financial
statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenue and expenses
and related disclosures. We review our estimates and judgments on an ongoing 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 consolidated
financial statements.
Revenue
Recognition
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.
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.
Our
revenue recognition policy affects the following revenue streams in our business as follows:
Systems:
| Column 1 | Column 2 |
|---|---|
| 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 may be covered by a one-year assurance-type warranty in lieu of a service-type warranty. Assurance-type warranty costs were less than $0.1 million for the year ended December 31, 2024 and approximately $0.5 million for the year ended December 31, 2023, respectively. |
Disposables:
| Column 1 | Column 2 |
|---|---|
| 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 periods presented. |
Royalty:
| Column 1 | Column 2 |
|---|---|
| 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:
| Column 1 | Column 2 |
|---|---|
| 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. |
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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. See Note 2 to the consolidated financial statements for additional details 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 approximately $0.1 million as of December 31, 2024 and 2023. respectively. 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, estimated warranty costs, initial training costs
and product maintenance costs. These costs are recorded at the time of sale. Costs of disposable revenue include direct product costs
and estimated warranty costs and are recorded at the time of sale. Cost of revenue from services and license fees are recorded when incurred.
Goodwill
and Intangible Assets
Goodwill
represents the excess of the purchase price over the fair value of the net assets acquired in business combinations and is allocated
to the appropriate reporting unit when acquired. Other acquired intangible assets are stated at the fair value acquired. Goodwill is
not amortized; rather, it is evaluated for impairment annually and whenever events or changes in circumstances indicate that the value
of the asset may be impaired. Definite-lived intangible assets are considered long-lived assets and are amortized on a straight-line
basis over the periods that expected economic benefits will be provided. See Note 3, Acquisitions for further discussion of the
goodwill and intangible assets recorded as of the acquisition date and as of December 31, 2024.
Contingent
Liabilities- Earnout Consideration
The
Company has determined that the contingent consideration due under the terms of its July 31, 2024, acquisition agreement with APT Holding
Company, Inc. represents a contingent liability in accordance with the provisions of Accounting Standard 805, Business Combinations.
The Company has established short-term and long-term contingent liabilities for the net present fair value of contingent payments which
are both probable of occurrence and reasonably estimable. The initial fair value of the contingent consideration was determined by a
third-party valuation firm using both a Monte Carlo simulation and probability based approaches. The contingent consideration is remeasured
to fair value at each reporting date until the contingency is resolved. Changes in fair value are recognized in the Company’s earnings
as a charge to General and Administrative expenses. See Note 3, Acquisitions for further discussion of the contingent consideration
recorded as of the acquisition date and as of December 31, 2024.
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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, 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 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 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.
Valuation
of Inventory
We
value our inventory at the lower of: (1) the actual cost of our inventory, determined using the first-in, first-out (FIFO) method, or
(2) its net realizable value. We periodically review our physical inventory for excess, obsolete, and potentially impaired items and
reserve accordingly. Our reserve estimate for excess and obsolete is based on expected future use. Excess manufacturing overhead costs
attributable to idle facility expenses or abnormally low production volumes are excluded from inventory and recorded as an expense in
the period incurred.
Income
Taxes
Deferred
tax assets and liabilities are determined based on the difference between the financial statement and tax basis of assets
and liabilities using the enacted tax rates in effect for the year in which the differences are expected to affect taxable income. Valuation
allowances are established when necessary to reduce deferred tax assets to the amounts expected to be realized. We have established a
valuation allowance against the entire amount of our deferred tax assets net of liabilities because we are not able to conclude, due
to our history of operating losses, that it is more likely than not that we will be able to realize any portion of the deferred tax assets.
In
assessing whether and to what extent deferred tax assets are realizable, we consider whether it is more likely than not that some portion
or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation
of future taxable income during the periods in which those temporary differences become deductible. We consider projected future taxable
income and tax planning strategies in making this assessment. Based upon the level of historical taxable losses, limitations imposed
by Section 382 of the Internal Revenue Code and projections for future losses over periods which the deferred tax assets are deductible,
we determined that a 100% valuation allowance of deferred tax assets net of liabilities was appropriate.
Results
of Operations
Comparison
of the Years ended December 31, 2024 and 2023
Revenue.
Revenue increased from $26.8 million for the year ended December 31, 2023, to $26.9 million for the year ended December 31, 2024, an
increase of less than 1%. Revenue from sales of systems decreased from $8.7 million for the year ended December 31, 2023, to $8.6 million
for the year ended December 31, 2024, a decrease of approximately 1%, driven by decreased system sales volumes in the current year period.
Revenue from sales of disposable interventional devices, service and accessories increased to $18.3 million for the year ended December
31, 2024, from $18.0 million for the year ended December 31, 2023, an increase of approximately 1%. The increase was primarily driven
by the contributions from our recent acquisition of APT partially offset by decreased service revenue in the current year period.
Cost
of Revenue. Cost of revenue increased from $11.9 million for the year ended December 31, 2023, to $12.3 million for the year ended
December 31, 2024, an increase of approximately 3%. As a percentage of our total revenue, overall gross margin was 54% and 56% for the
years ended December 31, 2024, and December 31, 2023, respectively. The decrease was primarily due to changes in product mix. Cost of
revenue for systems sold decreased from $8.1 million for the year ended December 31, 2023, to $6.9 million for the year ended December
31, 2024, primarily due to decreased system sales volume and changes in product mix in the current year period. Gross margin for systems
increased from $0.7 million for the year ended December 31, 2023, to $1.8 million for the year ended December 31, 2024. Cost of revenue
for disposables, service, and accessories increased from $3.9 million for the year ended December 31, 2023, to $5.4 million for the year
ended December 31, 2024. Gross margin for disposables, service and accessories was 70% for the current year period compared to 79% for
the year ended December 31, 2023, primarily driven by acquisition related accounting which required the valuation of acquired finished
good inventory to fair value.
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Research
and Development Expense. Research and development expenses decreased from $10.3 million for the year ended December 31, 2023, to
$9.8 million for the year ended December 31, 2024, a decrease of approximately 5%. This decrease was primarily driven by the reversal
of an accrued regulatory license fee.
Sales
and Marketing Expense. Sales and marketing expenses remained consistent at $12.4 million for the years ended December 31, 2024 and
2023.
General
and Administrative Expense. General and administrative expenses include finance, information systems, legal, and general management
expenses, amortization of acquisition related intangible assets, and the gain or loss associated with the remeasurement of the acquisition
related contingent consideration. General and administrative expenses increased from $14.1 million for the year ended December 31, 2023,
to $17.2 million for the year ended December 31, 2024, an increase of approximately 22%. This increase was primarily driven by the remeasurement
of the contingent consideration, higher administrative expenses and professional service fees in the current year period, and amortization
of the acquisition related intangible assets.
Interest
Income. Net interest income was $0.7 million for the year ended December 31, 2024, and $1.1 million for the year ended December 31,
2023. The decrease was driven by lower invested balances and declining interest rates in the current year period.
Income
Taxes
Realization
of deferred tax assets is dependent upon future earnings, the timing and amount of which are uncertain. Accordingly, net deferred tax
assets have been fully offset by valuation allowances as of December 31, 2024, and December 31, 2023, to reflect these uncertainties.
As of December 31, 2024, we had gross federal net operating loss carryforwards arising from our operations of approximately $134.9 million.
The federal net operating loss carryforwards reflect accumulated book losses reduced for the 2013 IRC Section 382 ownership change limitation
of $188.0 million, book/tax differences and expiration of carryforwards. The federal net operating loss carryforwards generated prior
to the 2018 tax year of approximately $98.8 million will expire between 2030 and 2037. The federal net operating losses generated in
2018 and thereafter will be carried forward indefinitely as a result of changes in the tax law following the Tax Cuts and Jobs Act (“TCJA”).
As of December 31, 2024, we had gross state net operating loss carryforward of approximately $38.1 million which will expire at various
dates between 2025 and 2043 if not utilized.
In
addition to the net operating loss carryovers related to our operations, in connection with our acquisition of APT as discussed in
Note 3, we acquired federal and state net operating loss and tax credit carryovers of APT. Our ability to utilize those carryovers
and credits will be limited under IRC Section 382. The Section 382 limited net operating loss carryovers total approximately $9.1
million, of which $0.6 million was incurred prior to the 2018 effective date of the TCJA and will expire between 2035 and 2037 with
the remainder available for indefinite carryforward. The applicable state net operating loss carryforwards related to APT are
approximately $9.6 million with $9.1 million expiring at various dates between 2030-2038 with the remaining carried forward
indefinitely. The acquired tax credit carryovers total $0.2 million for federal income tax purposes, which expire between 2036 and
2043, and state credit carryovers of $0.3 million, which expire between 2031 and 2038. Consistent with our conclusion with respect
the need for valuation allowances associated with our other deferred tax assets, the net deferred tax assets related to APT of $1.6
million at the acquisition date as well as those at December 31, 2024 were fully included in our valuation allowance.
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 December 31, 2024, our accumulated deficit was $561.7 million with cash and cash equivalents of $12.4 million, inclusive of restricted
cash. Since inception, we have financed our operations primarily through cash generated by operations and proceeds from our debt and
stock offerings.
Capital
Resources
As
of December 31, 2024 and 2023, the Company did not have any debt.
Liquidity
The
following table summarizes our cash flow by operating, investing and financing activities for years ended December 31, 2024 and 2023
(in thousands):
| Year Ended December 31, | ||||||||
|---|---|---|---|---|---|---|---|---|
| 2024 | 2023 | |||||||
| Cash flow used in operating activities | $ | (8,497 | ) | $ | (9,139 | ) | ||
| Cash flow provided by investing activities | 74 | 19,765 | ||||||
| Cash flow provided by financing activities | 297 | 81 |
Net
cash used in operating activities. We used approximately $8.5 million and $9.1 million of cash in operating activities during the
years ended December 31, 2024 and 2023, respectively. The decrease in cash used in operating activities was driven by the increased operating loss partially offset by changes in working capital.
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Net cash provided by investing activities.
Cash provided by investing activities for the year ended December 31, 2024, consisted of $0.1 million. The cash generated during the year
ended December 31, 2024, was primarily from cash acquired in the APT business acquisition. Cash
provided by investing activities for the year ended December 31, 2023, consisted of 19.8 million. The cash generated during the year ended
December 31, 2023, was from proceeds received from the maturity of short-term investments of $20.1 million, partially offset by $0.4 million
of cash paid for equipment, construction and design costs associated with our new facility.
Net cash provided by financing
activities. We generated approximately $0.3 million and $0.1 million of cash for the years ended December 31, 2024 and 2023, respectively.
The cash generated in both periods was driven by the exercise of stock options, net of issuance costs, and our employee stock purchase
program.
At December 31, 2024, we had working
capital of approximately $4.8 million, compared to a working capital of approximately $20.0 million at December 31, 2023. The decrease
in working capital was primarily driven by the net loss incurred and acquisition of APT during the year ended December 31, 2024.
Our principal source of liquidity
is cash provided by operations and by the issuance of common stock through the exercise of stock options and our employee stock purchase
program as well as cash received from past equity raises. In addition, the Company filed a universal shelf registration statement on Form
S-3 with the SEC in May 2023, which was declared effective by the SEC on June 6, 2023, registering for sale up to $100.0 million of any
combination of our common stock, preferred stock, debt securities, warrants, rights and/or units from time to time and at prices and on
terms that we may determine. The net proceeds of any securities we sell under our shelf registration statement may be used for general
corporate purposes, including among other possible uses, the acquisition of companies or businesses, repayment and refinancing of debt,
working capital and capital expenditures.
The Company believes the cash,
and cash equivalents on hand as of December 31, 2024, will be sufficient to meet its obligations as they become due in the ordinary course
of business for at least 12 months following the date of the consolidated financial statements included in this Annual Report on Form
10-K, as well as for periods beyond that 12-month period. Our cash requirements depend on numerous factors, including success of clinical
adoption within the installed base of robotic magnetic systems, new placements of capital systems, the resources we devote to developing
and supporting our products, and other factors. We expect to continue to fund our operations with cash resources primarily generated from
the proceeds of our past equity raises and from our working capital. In the future, we may finance cash needs through the sale of other
equity securities or non-core assets, strategic collaboration agreements, debt financings or through distribution rights.
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.
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