ITEM 1A. RISK FACTORS
Investing in our common
stock involves a high degree of risk. You should carefully consider the following risk factors, as well as the other information contained
in this report, before deciding whether to invest in shares of our common stock. If any of the following risks actually occur, our business,
financial condition, operating results, and prospects would suffer. In that case, the trading price of our common stock would likely decline
and you might lose all or part of your investment in our common stock. The risks described below are not the only ones we face. Additional
risks that we currently do not know about or that we currently believe to be immaterial may also impair our operations and business results.
Risks Related to Our Business and the Industry
in Which We Operate
A substantial portion of our revenue is derived
from a few customers. If we were to lose a key customer, it would have a material adverse effect on our business, financial condition,
and results of operations.
In fiscal 2024, our top three
customers accounted for 88% of our sales, with our current largest customer accounting for 71% of our sales. This customer has made purchase
commitments to us through a supply agreement to purchase surgical handpieces through calendar 2025, but there can be no assurance that
this customer will extend purchase commitments to us beyond that date. The loss of, or a material reduction in purchases from, this customer
or any of our significant customers would severely impact us, including having a material adverse effect on our business, financial condition,
cash flows, revenue, and results of operations.
A substantial portion of our business is
derived from our core business area that, if not serviced properly, may result in a material adverse impact upon our business, financial
condition, and results of operations.
In fiscal 2024, we derived
99% of our revenue from sales of our medical device products and related services. We believe that a primary factor in the market acceptance
of our products and services is the value they create for our customers. Our future financial performance will depend in large part on
our ability to continue to meet the increasingly sophisticated needs of our customers through the timely development, and successful introduction
and implementation, of new and enhanced products and services, while at the same time continuing to provide the value our customers have
come to expect from us. We have historically expended a significant percentage of our revenue on product development and believe that
significant continued product development efforts will be required to sustain our growth. Continued investment in our sales and marketing
efforts will also be required to support future growth.
There can be no assurance
that we will be successful in our product development efforts, that the market will continue to accept our existing products, or that
new products or product enhancements will be developed and implemented in a timely manner, meet the requirements of our customers, or
achieve market acceptance. If the market does not continue to accept our existing products, or our new products or product enhancements
do not achieve market acceptance, our business, financial condition, and results of operations could be materially adversely affected.
Our customers may cancel or reduce their orders, change production quantities,
or delay production, any of which would reduce our sales and adversely affect our results of operations.
Since
most of our customers purchase our products from us on a purchase order basis, they may cancel, change, or delay product purchase commitments
with little notice to us. As a result, we are not always able to forecast with certainty the sales that we will make in a given period
and sometimes we may increase our inventory, working capital, and overhead in expectation of orders that may never be placed, or, if placed,
may be delayed, reduced, or canceled.
The following factors, among others, affect our ability
to forecast accurately our sales and production capacity:
• Changes in the specific products or quantities our customers order; and
In addition to reducing our sales,
delayed, reduced, or canceled purchase orders also may result in our inability to recover costs that we incur in anticipation of those
orders, such as costs associated with purchased raw materials and write-offs of obsolete inventory.
In recent years, we have launched several
new medical device products and our estimates of warranty claims are based largely on our previous history from similar legacy products.
If actual warranty claims exceed our estimates, it could have an adverse effect on our results of operations and financial condition.
In recent years, we have completed
significant medical device development projects in the CMF and thoracic surgical segments for which we have made estimates of product
warranty claims based upon similar, legacy products. If the actual repair volumes or repair costs exceed the estimates that we have been
using, we may incur additional costs which could be materially adverse to our results of operations and financial condition.
We face significant competition from a number
of different sources, which could negatively impact our results of operations.
The markets for products
in the industries served by our customers are intensely competitive, and we face significant competition from a number of different sources.
Several of our competitors have significantly greater name recognition, as well as substantially greater financial, technical, product
development and marketing resources, than us.
We compete in all of our
markets with other major surgical device and related companies. As a provider of outsourced products and services, we also compete with
our customers’ own internal development groups. Competitive pressures and other factors, such as new product or new technology introductions
by us, our customers’ internal development and manufacturing departments, or our competitors, may result in price or market share
erosion that could have a material adverse effect on our business, results of operations and financial condition. Also, there can be no
assurance that our products and services will achieve broad market acceptance or will successfully compete with other products.
The industry in which we operate is subject to
significant technological change and any failure or delay in addressing such change could adversely affect our competitive position or
could make our current products obsolete.
The medical device market
is generally characterized by rapid technological change, changing customer needs, frequent new product introductions and evolving industry
standards. The introduction of products incorporating new technologies and the emergence of new industry standards could render our existing
products obsolete and unmarketable. There can be no assurance that we will be successful in developing and marketing new products that
respond to technological changes or evolving industry standards.
New product development
requires significant research and development expenditures that we have historically funded through operations; however, we may be unable
to do so in the future. Any significant decrease in revenues or research funding could impair our ability to respond to technological
advances in the marketplace and to remain competitive. If we are unable, for technological or other reasons, to develop and introduce
new products in a timely manner in response to changing market conditions or customer requirements, our business, results of operations,
and financial condition may be materially adversely affected. Although we continue to target new markets for access, develop new products,
and update existing products, there can be no assurance that we will do so successfully or that, even if we are successful, such efforts
will be completed concurrently with or prior to the introduction of competing products. Any such failure or delay could adversely affect
our competitive position or could make our current products obsolete.
We rely heavily on our proprietary technology,
which, if not properly protected or if deemed invalid, could have a material adverse effect on our business, financial condition, and
results of operations.
We are dependent on the
maintenance and protection of our proprietary technology and rely on patent filings, exclusive development and supply agreements, confidentiality
procedures and employee nondisclosure agreements to protect it. There can be no assurance that the legal protections and precautions taken
by us will be adequate to prevent misappropriation of our technology or that competitors will not independently develop technologies equivalent
or superior to ours. Further, the laws of some foreign countries do not protect our proprietary rights to as great an extent as do the
laws of the United States and are often not enforced as vigorously as those in the United States.
We do not believe that our
operations or products infringe on the intellectual property rights of others. However, there can be no assurance that others will not
assert infringement or trade secret claims against us with respect to our current or future products. Assertions or claims by others,
whether or not valid, could cause us to incur significant legal costs defending our intellectual property rights and potentially require
us to enter into a license agreement or royalty arrangement with the party asserting the claim or to cease our use of the infringing technology,
any of which could have a material adverse effect on our business, financial condition and results of operations.
If our technology infrastructure is compromised,
damaged or interrupted by a cybersecurity incident, data security breach or other security problems, our results of operations and financial
condition could be adversely affected.
We use technology in substantially
all aspects of our business operations, and our ability to serve customers most effectively depends on the reliability of our technology
systems. We use software and other technology systems, among other things, to generate sales orders, job orders, and purchase orders and
to monitor and manage our business on a day-to-day basis. Cybersecurity incidents can include computer viruses, computer denial-of-service
attacks, worms, and other malicious software programs or other attacks, covert introduction of malware to computers and networks, impersonation
of authorized users, and efforts to discover and exploit any design flaws, bugs, security vulnerabilities or security weaknesses, as well
as intentional or unintentional acts by employees or other insiders with access privileges, intentional acts of vandalism by third parties
and sabotage.
In addition, our technology
infrastructure and systems are vulnerable to damage or interruption from natural disasters, power loss and telecommunications failures.
Any such disruption to our systems, or the technology systems of third parties on which we rely, the failure of these systems to otherwise
perform as anticipated, or the theft, destruction, loss, misappropriation, or release of sensitive and/or confidential information or
intellectual property, could result in business disruption, negative publicity, loss of customers, potential liability, including litigation
or other legal actions against us or the imposition of penalties, fines, fees or liabilities, which may not be covered by our insurance
policies, and competitive disadvantage, any or all of which would potentially adversely affect our customer service, decrease the volume
of our business and result in increased costs and lower profits. Moreover, a cybersecurity breach could require us to devote significant
management resources to address the problems associated with the breach and to expend significant additional resources to upgrade further
the security measures we employ to protect information against cyber-attacks and other wrongful attempts to access such information, which
could result in a disruption of our operations.
While we have invested,
and continue to invest, in technology security initiatives and other measures to prevent security breaches and cyber incidents, as well
as disaster recovery plans, these initiatives and measures may not be entirely effective to insulate us from technology disruption that
could result in adverse effects on our results of operations and financial condition.
To service our debt obligations, we will require
a significant amount of cash. However, our ability to generate cash depends on many factors beyond our control.
Our ability to make payments
on, and to refinance, our debt obligations and to fund capital expenditures, will depend on our ability to generate cash in the future,
which, in turn, is subject to general economic, financial, competitive, regulatory and other factors, many of which are beyond our control.
Our business may not generate
sufficient cash flow from operations, and we may not have available to us future borrowings in an amount sufficient to enable us to pay
our debt obligations or to fund our other liquidity needs. In these circumstances, we may need to refinance all or a portion of our debt
obligations on or before maturity. We may not be able to refinance any of our debt obligations, on commercially reasonable terms, or at
all. Without this financing, we could be forced to sell assets or secure additional financing to make up for any shortfall in our payment
obligations under unfavorable circumstances. However, we may not be able to secure additional financing on terms favorable to us or at
all and, in addition, the agreements governing our debt obligations limit our ability to sell assets. In addition, we may not be able
to sell assets quickly enough or for sufficient amounts to enable us to meet our obligations.
Our cash and cash equivalents may be exposed to
banking institution risk.
We hold our cash balances with
a single financial institution which institution is subject to risks, which may include failure or other circumstances that limit our
access to deposits or other banking services. For example, in March 2023, Silicon Valley Bank (“SVB”) was unable to continue
their operations and the Federal Deposit Insurance Corporation (“FDIC”) was appointed as receiver for SVB. However, if similar
failures in financial institutions occur where we hold deposits, we could experience additional risk. Any such loss or limitation on our
cash and cash equivalents would adversely affect our business.
In addition, in such circumstances
we might not be able to receive timely payment from customers. We and they may maintain cash balances that are not insured or are in excess
of the FDIC’s insurance limit. Any delay in ours or our customers’ ability to access funds could have a material adverse effect
on our operations. If any parties with which we conduct business are unable to access funds pursuant to such instruments or lending arrangements
with such a financial institution, such parties’ ability to continue to fund their business and perform their obligations to us
could be adversely affected, which, in turn, could have a material adverse effect on our business, financial condition and results of
operations.
We periodically invest surplus cash in marketable
securities and other investments in order to realize a positive return, although there can be no assurance that a positive return will
be realized, and we could lose some or all of our investments, which could adversely affect our financial condition and results of operation.
We invest a significant portion
of our excess capital in marketable securities, including equity securities of publicly traded companies. At June 30, 2024, the fair value
of our investments was approximately $5.8 million. Of that amount $3.2 million relates to an investment in Monogram Technologies, Inc.,
formerly Monogram Orthopaedics Inc. (“Monogram”), described more fully in Note 4 to the consolidated financial statements
contained elsewhere in this report. While we intend to hold our investments, including our investment in Monogram, until such time as
we believe it is appropriate to sell them in accordance with our overall investment policy, we may have unexpected cash requirements that
could necessitate the sale of some or all of these investments for a loss. Additionally, these investments are subject to changes in their
valuation, and are recorded at their estimated fair value at each measurement date, with unrealized gains and losses presented in other
income (expense) in our consolidated income statements, which can result in material upward or downward non-cash adjustments to our income
from quarter-to-quarter.
Our operations are dependent upon our key personnel.
If such personnel were to leave unexpectedly, we may not be able to execute our business plan.
Our future performance depends
in significant part upon the continued service of our key technical and senior management personnel. Because we have a relatively small
number of employees when compared to other companies in the same industry, our dependence on maintaining our relationship with key employees
is particularly significant. We are also dependent on our ability to attract and retain high quality personnel, particularly in the areas
of product development, operations management, marketing and finance.
A high level of employee
mobility and the aggressive recruiting of skilled personnel characterize the medical device industry. There can be no assurance that our
current employees will continue to work for us. Loss of services of key employees could have a material adverse effect on our business,
results of operations, and financial condition. Furthermore, we may need to provide enhanced forms of incentive compensation to attract
and retain such key personnel, which could potentially dilute the holdings of other shareholders.
We may not be able to successfully integrate our business acquisitions,
which could adversely affect our business, financial condition, and results of operations.
We have acquired, and may
acquire in the future, businesses, products, and technologies that complement or expand our current operations. Acquisitions could require
significant capital investments and require us to integrate with companies that have different cultures, management teams, and business
infrastructure. Depending on the size and complexity of an acquisition, our successful integration of the acquisition could depend on
several factors, including:
• The retention of key employees;
• Management of facilities and employees in separate geographic areas;
• Successfully converting information and accounting systems; and
• Diversion of resources and management attention from our other operations.
If market conditions or
other factors require us to change our strategic direction, we may fail to realize the expected value from one or more of our acquisitions.
Our failure to successfully integrate any future acquisitions or realize the expected value from past or future acquisitions could harm
our business, financial condition, and results of operations.
We have experienced losses in the past, and we cannot be certain that
we will sustain our current profitability; we may need additional capital in the future to fund our businesses, which we may not be able
to obtain on acceptable terms.
We have experienced operating
losses in the past. Our ability to achieve or sustain profitability is based on a number of factors, many of which are out of our control,
including the material costs for our products and the demand for our products.
We currently anticipate that our
available capital resources, including our existing cash and cash equivalents and accounts receivable balances, will be sufficient to
meet our expected working capital and capital expenditure requirements as our business is currently conducted for at least the next 12 months.
However, if our available capital resources become insufficient, we may attempt to raise additional funds through public or private debt
or equity financings, if such financings become available on acceptable terms. We cannot be certain that any additional financing we may
need will be available on terms acceptable to us, or at all. If adequate funds are not available or are not available on acceptable terms,
we may not be able to take advantage of opportunities, develop new products, or otherwise respond to competitive pressures, and our operating
results and financial condition could be adversely affected.
Risks Related to Ownership of Our Common
Stock
Two of our directors hold voting power with
respect to a substantial portion of our outstanding common stock that enables them to have significant influence over the outcome of all
matters submitted to our shareholders for approval, which influence may conflict with our interests and the interests of other shareholders.
As of August 20, 2024, two
of our directors, Nicholas J. Swenson and Raymond E. Cabillot, directly or indirectly, controlled voting power over approximately 42%
(31% and 11%, respectively) of the outstanding shares of our common stock. As a result of such voting control, these directors will have
significant influence over all matters submitted to our shareholders for approval, including the election of our directors and other corporate
actions, and may have interests that conflict with our interests and the interests of other shareholders.
Our quarterly results can fluctuate significantly
from quarter to quarter, which may negatively impact the price of our shares and/or cause significant variances in the prices at which
our shares trade.
Our sales have fluctuated
in the past, and may fluctuate in the future from quarter to quarter and period to period, as a result of a number of factors, including,
without limitation: the size and timing of orders from customers; the length of new product development cycles; market acceptance of new
technologies; changes in pricing policies or price reductions by us or our competitors; the timing of new product announcements and product
introductions by us or our competitors; the financial stability of major customers; our success in expanding our sales and marketing programs;
acceleration, deferral, or cancellation of customer orders and deliveries; changes in our strategy; revenue recognition policies in conformity
with accounting principles generally accepted in the United States (“U.S. GAAP”); personnel changes; and general market and
economic factors.
Because a significant percentage
of our expenses are fixed, a variation in the timing of sales can cause significant fluctuations in operating results from quarter to
quarter. As a result, we believe that interim period-to-period comparisons of our results of operations are not necessarily meaningful
and should not be relied upon as indications of future performance. Further, our historical operating results are not necessarily indicative
of future performance for any particular period.
In addition, it is possible
that our operating results in future quarters may be below the expectations of public market analysts and investors. In such an event,
the price of our common stock could be materially adversely affected.
Regulatory & Compliance Risks
Our operations are subject to a number of
complex government regulations, the violation of which could have a material adverse effect on our business.
The manufacture and distribution
of medical devices are subject to state and federal requirements set forth by various government agencies including the FDA and EPA. The
statutes, regulations, administrative orders, and advisories that affect our businesses are complex and subject to diverse, often conflicting,
interpretations. While we make every effort to maintain full compliance with all applicable laws and regulations, we are unable to eliminate
the ongoing risk that one or more of our activities may at some point be determined to be non-compliant. The penalties for non-compliance
could range from an administrative warning to termination of a portion of our business. Furthermore, even if we are subsequently determined
to have fully complied with applicable laws or regulations, the costs to achieve such a determination and the intervening loss of business
could adversely affect or result in the cessation of a portion of our business. A change in such laws or regulations at any time may have
an adverse effect on our operations.
The FDA designates all medical
devices into one of three classes (Class I, II, or III) based on the level of control necessary to assure the safety and effectiveness
of the device (with Class I requiring the lowest level of control and Class III requiring the greatest level of control). The surgical
instrumentation we manufacture is generally classified into Class I. The FDA has broad enforcement powers to recall and prohibit the sale
of products that do not comply with federal regulations and to order the cessation of non-compliant processes. No claim has been made
to date by the FDA regarding any of our products or processes. Nevertheless, as is common in the industry, certain of our products and
processes are from time to time subject to routine governmental reviews and investigations. We are also subject to EPA regulations concerning
the disposal of industrial waste.
While management believes
that our products and processes fully comply with applicable laws and regulations, we are unable to predict the outcome of any such future
review or investigation.
We face risks and uncertainties associated
with potential litigation by or against us, which could have a material adverse effect on our business, financial condition, and results
of operations.
We continually face the
possibility of litigation as either a plaintiff or a defendant. It is not reasonably possible to estimate the awards or damages, or the
range of awards or damages, if any, that we might incur in connection with such litigation.
Many of our products are
complex and technologically advanced. Such products may, from time to time, be the subject of claims concerning product performance
and construction, including warranty and patent infringement claims. While we are committed to investigating such concerns and correcting
them, there is no assurance that solutions will be found on a timely basis, if at all, to satisfy customer demands or to avoid potential
claims or litigation. Also, due to the location of our facilities, as well as the nature of our business activities, there is a risk that
we could be subject to litigation related to environmental remediation claims. We maintain insurance to protect against claims associated
with the manufacture and use of our products as well as environmental pollution, but there can be no assurance that our insurance coverage
will adequately cover any claim asserted against us.
The uncertainty associated
with potential litigation may have an adverse impact on our business. In particular, litigation could impair our relationships with existing
customers and our ability to obtain new customers. Defending or prosecuting litigation could result in significant legal costs and a diversion
of management’s time and attention away from business operations, either of which could have a material adverse effect on our business,
financial condition, and results of operations. There can be no assurance that litigation would not result in liability in excess of our
insurance coverage, that our insurance will cover such claims, or that appropriate insurance will continue to be available to us in the
future at commercially reasonable rates.
The agreements governing our various debt obligations
impose restrictions on our business and could adversely affect our ability to undertake certain corporate actions.
The agreements governing
our debt obligations include covenants imposing significant restrictions on our business. These restrictions may affect our ability to
operate our business and may limit our ability to take advantage of potential business opportunities as they arise. These covenants place
restrictions on our ability to, among other things:
•
incur additional debt;
• declare
or pay dividends to shareholders;
•
create liens or use assets as security in other transactions;
•
be acquired by a third party;
•
pursue strategic acquisitions;
• engage
in transactions with affiliates; and
•
sell or transfer assets.
The agreements governing
our debt obligations also require us to comply with a number of financial ratios, borrowing base requirements and additional covenants.
Our ability to comply with
these covenants may be affected by events beyond our control, including prevailing economic, financial, and industry conditions. These
covenants could adversely affect our business by limiting our ability to take advantage of financing, merger and acquisition, or other
corporate opportunities. The breach of any of these covenants or restrictions could result in a default under our debt obligations. If
we were unable to repay our debt or are otherwise in default under any provision governing our secured debt obligations, our lender could
proceed against us and against the collateral (consisting of substantially all of our assets) securing that debt.
We are subject to changes in and interpretations of financial accounting
matters that govern the measurement of our performance, compliance with which could be costly and time-consuming.
We are subject to changes
in and interpretations of financial accounting standards that govern the measurement of our performance. Based on our reading and interpretations
of relevant pronouncements, guidance, or concepts issued by, among other authorities, the Financial Accounting Standards Board, the SEC,
and the American Institute of Certified Public Accountants, management believes our performance, including current sales contract terms
and business arrangements, has been properly reported. However, there continue to be issued pronouncements, interpretations, and guidance
for applying the relevant standards to a wide range of contract terms and business arrangements that are prevalent in the industries in
which we operate. Future interpretations or changes by the regulators of existing accounting standards or changes in our business practices
may result in future changes in our accounting policies and practices that could have a material adverse effect on our business, financial
condition, cash flows, revenue, and results of operations.
We have identified material weaknesses in
our internal control over financial reporting. Failure to achieve and maintain effective internal control over financial reporting could
materially and adversely affect our business, results of operations, financial condition, and stock price.
We identified material weaknesses
in our internal control over financial reporting as of June 30, 2024, and June 30, 2023. The material weaknesses as of June 30,
2024, related to our inventory accounting and the valuation of one of our Level 2 investments. The material weakness as of June 30,
2023, related to the valuation of our Level 3 investment. As a result of these material weaknesses, as of June 30, 2024, and
June 30, 2023, our management concluded that our internal control over financial reporting was not effective based on the framework
in Internal Control-Integrated Framework (2013), issued by the Committee of Sponsoring Organizations of the Treadway Commission.
In fiscal 2024, we implemented
a remediation plan designed to address our June 30, 2023 material weakness, which was both time consuming and costly. We are actively
engaged in implementing a remediation plan designed to address the June 30, 2024 material weaknesses. However, as with the June 30,
2023 material weakness, our remediation efforts could be both time consuming and costly. In addition, if our remedial measures are insufficient
to address the material weaknesses, or if additional material weaknesses or significant deficiencies in our internal control are discovered
or occur in the future, our consolidated financial statements may contain material misstatements and we could be required to restate our
financial results.
Even if the June 30,
2024 material weaknesses are quickly remedied, or if we or our auditors discover one or more additional material weaknesses in our internal
controls, the market’s confidence in our financial statements could decline and our stock price may be harmed. In addition, our
failure to maintain effective controls over financial reporting could subject us to sanctions or investigations by The Nasdaq Stock Market,
the SEC, or other regulatory authorities.
Our evaluation of internal controls and remediation
of potential problems is costly and time-consuming and could expose weaknesses in financial reporting.
Section 404 of the Sarbanes-Oxley
Act of 2002, as amended, requires management’s assessment of the effectiveness of our internal control over financial reporting.
This process is expensive and time consuming and requires significant attention of management. Management can give no assurance that material
weaknesses in internal controls will not be discovered (see above, “We have identified material weaknesses in our internal control
over financial reporting. Failure to achieve and maintain effective internal control over financial reporting could materially and adversely
affect our business, results of operations, financial condition, and stock price.”). We cannot be certain that a future material
weakness will not occur and that it will not be time consuming and costly to remediate and could further divert the attention of management.
The disclosure of a material weakness, even if quickly remedied, could reduce the market’s confidence in our financial statements
and harm our stock price, especially if a restatement of financial statements for past periods is required.
General Risks
The global economic environment may impact
our business, financial condition, and results of operations.
Changes in the global economic
environment have caused, and may cause in the future, a general tightening in the credit markets, lower levels of liquidity, increases
in rates of default and bankruptcy, high rates of inflation, higher interest rates, and extreme volatility in credit, equity and fixed
income markets. These macroeconomic developments could negatively affect our business, operating results or financial condition should
they cause, for example, current or potential customers to become unable to fund purchases of our products, in turn resulting in
delays, decreases or cancellations of purchases of our products and services, or causing the customer to not pay us or to delay paying
us for previously purchased products and services. In addition, financial institution failures may cause us to incur increased expenses
or make it more difficult either to obtain financing for our operations, investing activities (including the financing of any future acquisitions),
or financing activities. Additional economic risks and uncertainties not currently known to us or that we currently deem to be immaterial
also may materially and adversely affect our business, financial condition, and results of operations.
ITEM 1B. UNRESOLVED STAFF COMMENTS
None.
ITEM 1C. CYBERSECURITY
Risk management and strategy
We have implemented and maintain
various information security processes in accordance with our business designed to identify, assess, manage and protect against material
risks from cybersecurity threats to our critical computer networks, communication systems, hardware and software, and our critical data,
including intellectual property and confidential information.
Depending on the environment,
we implement and maintain various technical, physical and organizational measures, processes, and policies designed to manage and mitigate
material risks from cybersecurity threats to our information systems and data, including, for example, incident detection and response
plans; disaster recovery and business continuity plans; maintaining network security and access controls; asset management; monitoring
certain of our systems and network; cybersecurity insurance; and training our employees about certain cybersecurity risks and threats.
We currently engage third party
information technology partners to design and manage our information security processes and system. Working with our outsourced security
team, our Chief Financial Officer manages the risk assessment and mitigation process. We have budgeted to add information technology staff
to our organization to increase our in-house expertise in this area. As we grow, we plan to develop a more robust and detailed strategy
for cybersecurity.
Governance
Cybersecurity risks are overseen
by the full Board of Directors and the Audit Committee as part of their regular oversight. Members of the Board and Audit Committee are
encouraged to engage in ad hoc conversations with management on cybersecurity related updates to our risk management and strategy. Cybersecurity
incidents are reported to the Chief Financial Officer to determine incident severity and response. In an effort to deter and detect cyber
threats, we also provide all employees with access to digital assets with an ongoing cybersecurity awareness training program, which further
educates employees and covers timely and relevant topics, including phishing, password protection, asset use and mobile security.
Risks from cybersecurity threats
To date, we have not identified
any cybersecurity incidents or threats that have materially affected us, or are reasonably likely to materially affect us, including our
business strategy, results of operations, or financial condition. However, like many companies in our industry, we face numerous and evolving
cybersecurity threats that could adversely affect our business. For more information about the risks from cybersecurity threats that may
materially affect us and how they may do so, see our risk factors under Part 1 Item 1A Risk Factors contained elsewhere in this report.
ITEM 2. PROPERTIES
Our executive offices and
manufacturing facility are located at 2361 McGaw Avenue, Irvine, California 92614. We lease the 28,000 square foot facility from an unrelated
third party at a current base monthly lease rate of approximately $44,000 with 3% annual escalations through the expiration of the lease
in September 2027. The building is a one-story, stand-alone structure of concrete “tilt-up” construction, approximately 45
years old and in good condition.
Our Franklin Property, located
at 14401 Franklin Avenue, Tustin, California 92780, is used primarily for our assembly and repairs operations. We purchased this 25,000
square foot facility in November 2020 from an unrelated third party, with the majority of the purchase price financed by a property loan
(See Notes 4 and 7 of to the consolidated financial statements contained elsewhere in this report). The building is a one-story, stand-alone
structure of concrete “tilt-up” construction, approximately 45 years old and in good condition.
We believe that our facilities
are adequate for our current and expected future needs and are in full compliance with applicable state, EPA and other agency environmental
standards.
ITEM 3. LEGAL PROCEEDINGS
See
Note 9 to the consolidated financial statements contained elsewhere in this report.
ITEM 4. MINE SAFETY DISCLOSURES
Not applicable.
PART II
Market Information
Our common stock is quoted
under the symbol “PDEX” on the Nasdaq Capital Market (“NASDAQ”). The following table sets forth for the quarters
indicated the high and low sales prices of our common stock as reported by NASDAQ. The quotations reflect inter-dealer prices, without
retail markup, markdown, or commissions, and may not necessarily represent actual transactions. On September 3, 2024, the last sale price
of our common stock as reported by NASDAQ was $22.33 per share.
High Low
Holders
As of September 3, 2024,
there were 122 holders of record of our common stock. This number does not include beneficial owners including holders whose shares are
held in nominee, or “street,” name.
Dividends
We have never paid a cash
dividend with respect to our common stock. The current policy of our Board of Directors is to retain any future earnings to provide funds
for the operation and expansion of our business or for repurchases of our common stock pursuant to our repurchase plans. Any determinations
to pay dividends in the future will be at the discretion of our Board of Directors. In addition, our current credit facilities contain
covenants that prohibit us from paying dividends.
Repurchases
During
the fourth quarter of fiscal 2024 and 2023, we repurchased 88,011 and 0 shares of our common stock, respectively, at an aggregate cost
of $1.7 million and $0, respectively, through Board approved prearranged share repurchase plans intended to qualify for the safe harbor
under Rule 10b5-1 under the Securities Exchange Act of 1934, as amended (the “Exchange Act”).
(1) In
December 2019, we announced that our Board of Directors authorized the repurchase of up to one million shares of our outstanding common
stock. The extent to which we repurchase our shares, and the timing of such repurchases is at our discretion and will depend upon a variety
of factors, including working capital requirements, market conditions, legal requirements, business condition, and other factors. Our
repurchase program has no stated expiration and may be discontinued at any time
ITEM 6. RESERVED
The following discussion
of our financial condition and results of operations should be read in conjunction with our consolidated financial statements and the
notes thereto contained elsewhere in this report, as well as the Risk Factors included in Item 1A of this report. The following discussion
contains forward-looking statements. (See “Cautionary Note Regarding Forward-Looking Statements” included in Part I of this
report.)
Overview
The following discussion and analysis
provides information that management believes is relevant to an assessment and understanding of our results of operations and financial
condition for the fiscal years ended June 30, 2024 and 2023.
We specialize in the design, development,
and manufacture of autoclavable, battery-powered and electric, multi-function surgical drivers and shavers used primarily in the orthopedic,
thoracic, and CMF markets. Additionally, we provide engineering, quality, and regulatory consulting
services to our customers. We also sell rotary air motors. Our products are found in hospitals, medical engineering labs, scientific
research facilities, and high-tech manufacturing operations around the world. We are headquartered in Irvine, California.
Critical Accounting Policies and Estimates
Our consolidated financial
statements are prepared in accordance with U.S. GAAP. The preparation of our financial statements requires management to make estimates
and judgments that affect the reported amounts of assets, liabilities, revenues, expenses, and related disclosures. We base our estimates
on historical experience and various other assumptions that are believed to be reasonable under the circumstances, the results of which
form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources.
Actual results may differ from these estimates.
Revenue Recognition
Under Accounting Standards Update
(“ASU”) 2014-09, (Topic 606) “Revenue From Contracts with Customers,” we recognize revenue from the sales
of products and services by applying the following steps: (1) identify the contract with a customer; (2) identify the performance obligations
in the contract; (3) determine the transaction price; (4) allocate the transaction price to each performance obligation in the contract;
and (5) recognize revenue when each performance obligation is satisfied. We primarily sell finished products and recognize revenue at
point of sale or delivery. However, we also perform services when we are engaged to design a product for a customer and there is more
judgment involved in determining the amount and timing of revenue recognition under those types of contracts. In fiscal 2024, the revenue
from NRE and prototype services represents approximately 1% of total revenue.
Returns of our product for
credit are not material; accordingly, we do not establish a reserve for product returns at the time of sale.
Estimated Losses on Product Development Services
Cost
and revenue estimates related to the product development service portions of development and supply contracts are reviewed and updated
quarterly. An expected loss on development service contracts is recognized immediately in cost of sales. Losses recorded in fiscal 2024
and 2023 related to these services totaled $118,000 and $108,000, respectively.
Due
to the complexity of many of the contracts we have undertaken, the cost estimation process requires significant judgment. It is based
upon the knowledge and experience of our project managers, engineers, and finance professionals. Factors that are considered in estimating
the cost of work to be completed and ultimate profitability of the fixed price product development portion of development and supply contracts
include the nature and complexity of the work to be performed, availability and productivity of labor, the effect of change orders, the
availability of materials, performance of subcontractors, and expected costs for specific regulatory approvals.
Warranties
Most of our products are
sold with a warranty that provides for repairs or replacement of any defective parts for a period, generally one to two years, after the
sale. At the time of the sale, we accrue an estimate of the cost of providing the warranty based on prior experience with such factors
as return rates and repair costs, which factors are reviewed quarterly.
Warranty expenses, including
changes of estimates, are included in cost of sales in our statements of operations.
Inventories
Inventories are stated
at the lower of cost (first-in, first-out method) or net realizable value. Reductions to estimated net realizable value are recorded,
and charged to cost of sales, when indicated based on a formula that compares on-hand quantities to both historical usage and estimated
demand from the measurement date.
Accounts Receivable
Trade receivables are stated
at their original invoice amounts, less an allowance for credit losses. Management determines the allowance for credit losses based on
facts and circumstances related to specific accounts, and on historical experience related to the age of accounts. Trade receivables are
written off when deemed uncollectible. Recoveries of trade receivables previously reserved are offset against the allowance when received.
Deferred Costs
Deferred costs reflect
costs incurred related to NRE services under the terms of the related development and supply contracts. These costs get recorded to cost
of sales in the period that the revenue is recognized.
Investments
Investments consist
of marketable equity securities of publicly held companies and, as of June 30, 2023, a warrant (the “Monogram Warrant”) to
purchase common stock of a publicly held company (which we exercised in the second quarter of fiscal 2024). The investments were made
to realize a reasonable return, although there is no assurance that positive returns will be realized. Investments are marked to market
at each measurement date, with unrealized gains and losses presented in other income (expense) in our consolidated income statements.
Some of our investments include the common stock of public companies that are thinly traded. Certain of these investments are classified
as long-term in nature, as we may not be able to liquidate the investments in a timely manner even if we wish to sell them. All of our
investments were subject to a valuation analysis as of June 30, 2024 and 2023.
Long-lived Assets
We review the recoverability
of long-lived assets, consisting of building, equipment, and improvements, when events or changes in circumstances occur that indicate
carrying values may not be recoverable.
Building, equipment, and
improvements are recorded at historical cost and depreciation is provided using the straight-line method over the following periods:
Building Thirty years
Equipment Three to ten years
Intangibles
Other
intangibles consist of legal fees incurred in connection
with patent applications. The legal fees will be amortized over the estimated life of the product(s) that will be utilizing the technology
or expensed immediately in the event the patent office denies the issuance of the patent. The expense associated with the amortization
of the patent costs is recognized in research and development costs.
Income Taxes
We recognize deferred tax
assets and liabilities for temporary differences between the financial reporting basis and the tax basis of our assets and liabilities,
along with net operating loss and tax credit carryovers. Deferred tax assets and liabilities at June 30, 2024 and 2023 consisted primarily
of basis differences related to unrealized gain/loss related to investments, stock-based compensation, fixed assets, accrued expenses
and inventories. Deferred tax assets and liabilities are adjusted for the effects of changes in tax laws and rates on the date of enactment.
Significant management judgment
is required in determining our provision for income taxes and the recoverability of our deferred tax assets. Such determination is based
on our historical taxable income, with consideration given to our estimates of future taxable income and the periods over which deferred
tax assets will be recoverable. In evaluating our ability to recover our deferred tax assets, we consider all available positive and negative
evidence, including reversals of deferred tax liabilities, projected future taxable income, and results of recent operations. The assumptions
about future taxable income require significant judgment and are consistent with the plans and estimates we are using to manage the underlying
business. In evaluating the objective evidence that historical results provide, we consider three years of cumulative operating income
(loss).
Results of Operations for the Fiscal Year Ended
June 30, 2024 Compared to the Fiscal Year Ended June 30, 2023
The following tables set
forth results from operations for the fiscal years ended June 30, 2024 and 2023:
Years Ended June 30,
Dollars in thousands
% of Net Sales % of Net Sales
General and administrative expenses 4,072 8 % 4,028 9 %
Other income (expense), net (4,539 ) (8 %) 3,666 7 %
Net Sales
The
majority of our revenue is derived from designing, developing, manufacturing and\ repairing
powered surgical instruments for medical device original equipment manufacturers. We also manufacture
and sell rotary air motors to a wide range of industries. The proportion of total sales by product/service
type is as follows:
Years Ended June 30, Increase (Decrease) From 2023
Dollars in thousands
% of Net Sales % of Net Sales
Net sales:
Net
sales in fiscal 2024 increased by $7.8 million, or 17%, as compared to fiscal 2023, due primarily to an increase in repair revenue of
$3.9 million and an increase in medical device revenue of $6.2 million offset by a decrease in NRE and prototype services of $1.9 million.
Details of our medical device sales by type is as follows:
Years Ended June 30, Increase (Decrease) From 2023
Dollars in thousands
% of Total % of Total
Medical device sales:
Sales
of our medical device products increased $6.2 million, or 20%, during fiscal 2024 as compared to fiscal 2023. During fiscal 2024, thoracic
sales increased by $460,000 to $3.0 million, up from $2.6 million in fiscal 2023, due to a product launch for a second distributor in
the first quarter of fiscal 2024. Recurring revenue from distributors of CMF drivers increased $1.8 million in fiscal 2024 compared
to fiscal 2023. We do not have much visibility into our customers’ distribution networks, but we surmise the increase relates to
a replenishment of customer inventory. Our orthopedic sales increased $3.9 million in fiscal 2024 compared to fiscal 2023, due to continued
demand from our largest customer.
Sales
of our industrial and scientific products, which consist primarily of our compact pneumatic air
motors, decreased $100,000, or 12%, for fiscal 2024 compared to fiscal 2023. The revenue decrease is expected as these are legacy products
with no substantive marketing or sales efforts.
Sales
of our NRE & prototype services decreased $1.9 million or 71% compared to fiscal 2023 and relates to a reduction in the number of
billable engagements during fiscal 2024 compared to fiscal 2023.
Sales
of our dental products and components in fiscal 2024 decreased $56,000, or 22%, as compared to fiscal 2023. The decrease is as expected
and we expect future declines in this area as we are no longer manufacturing dental products, but rather are simply selling remaining
component inventory.
Our
fiscal 2024 repair revenue increased approximately $3.9 million, or 31%, to $16.5 million, as compared to fiscal 2023, due to increased
repairs of the orthopedic handpiece we sell to our largest customer. We expected repair revenue to increase based upon the customer’s
requested refurbishments to upgrade previously purchased handpieces to the next generation, which we collectively term “enhanced
repairs”. We are rapidly refurbishing these handpieces and we believe that our largest customer will request enhanced repairs for
a similar volume or number of handpieces in fiscal 2025; however, there are no assurances as to the number of enhanced repairs that will
ultimately be requested from this client in fiscal 2025 or thereafter.
At June 30, 2024, we
had a backlog of $19.8 million compared with a backlog of $41.6 million at June 30, 2023. Our backlog represents firm purchase orders
received and acknowledged from our customers and does not include all revenue expected to be generated from existing customer contracts.
Substantially all of our backlog at June 30, 2024, as well as certain purchase orders received subsequent to June 30, 2024, are expected
to be delivered during fiscal 2025. We have experienced, and may continue to experience, variability in our new order bookings due to,