ITEM 1A. RISK FACTORS
RISK FACTORS
An investment in our common stock involves significant risks. Before
making an investment in our common stock, you should carefully consider all of the information contained in this Annual Report on Form
10-K and our other filings with the SEC including the material risks and uncertainties that we have identified below. The risks
and uncertainties identified below are not the only risks and uncertainties we face. If any of the material risks or uncertainties
that we face were to occur, the trading price of our common stock could decline and you could lose part or all of your investment. Please
note that additional risks not currently known to us or that we currently deem immaterial also may adversely affect our business, operations,
results of operations, financial condition and prospects.
Risks Related to Our Business
If we are unable to successfully introduce new products or fail to
keep pace with advances in technology, our business, financial condition and results of operations could be adversely affected.
We need to successfully introduce new products to achieve our strategic
business objectives. A significant element of our strategy is to increase revenue growth by investing in innovation and new product
development, which will require substantial resources. Our successful product development will depend on many factors, including
our ability to attract strong talent to lead our research and development efforts, properly anticipate and satisfy customer needs, adapt
to new technologies, obtain regulatory concurrence on a timely basis, demonstrate satisfactory clinical results, manufacture products
in an economical and timely manner, obtain appropriate intellectual property protection for our products, gain and maintain market acceptance
of our products, and differentiate our products from those of our competitors. In addition, patents attained by others can preclude
or delay our commercialization of a product. There can be no assurance that any products now in development or that we may seek to develop
in the future will achieve technological
feasibility, obtain regulatory concurrence or gain market acceptance. If
we cannot successfully introduce new products or adapt to changing technologies, our products may become obsolete, and our revenue and
profitability could suffer.
Our business depends on an adequate supply of drugs to be administered
by our products.
Demand for our products depends on the availability of drugs to be administered
through our delivery system. Currently, most of our products require immunoglobulin therapies that rely on blood plasma collection
for drugs such as Hizentra® and Cuvitru®. Any disruption in the supply of these drugs for any reason, including contamination,
could significantly adversely affect our business. The change of any drug indication by the FDA or comparable foreign governmental
agencies could also result in decreased demand for our products. In addition, pharmaceutical companies and other competitors have
or are developing alternative therapies for disease states that are deliverable with devices we do not offer or without a medical device.
If there is not an adequate supply of drugs requiring administration by medical devices such as those provided by us or alternative
therapies are developed, our sales may suffer and/or our products may become obsolete.
The size of the markets for our products and any future products
may be smaller than we estimate and may decline.
Our estimates of the total addressable market for our products are based
on a number of internal and third-party estimates and assumptions, including, without limitation, the assumed prices at which we can
sell our products in those markets. While we believe our assumptions and the data underlying our estimates are reasonable, these assumptions
and estimates may not be correct and the conditions supporting our assumptions or estimates may change at any time, thereby reducing
the predictive accuracy of these underlying factors.
As a result, our estimates of the annual total addressable market for
our products may prove to be incorrect. If the actual number of patients with indications who would benefit from our products, the price
at which we can sell our products or the annual total addressable market for our products is smaller than we have estimated, it may impair
our prospective market and revenue opportunity.
We sell a majority of our products through only a few distributors
on whom we depend, and our financial results depend on their purchasing patterns.
Most of our customers prefer to purchase our products through distributors,
rather than directly from us, because of “one-stop shopping” convenience and their ability to ship directly to patients. We
sell most of our products through a small number of distributors, three in the U.S. and six outside the U.S. As of December 31,
2025, these nine distributors comprised approximately 77% of our net revenues with one U.S. distributor contributing 29%. Purchasing
patterns by these distributors cannot always be predicted and fluctuate from quarter to quarter and year to year based on, among other
things, their expectations of customer demand. Any decline in business with the distributors outside the U.S. could have an adverse
impact on our business. If we were unable to sell through the distributors outside the U.S., we would have to find other distributors
or broaden our customer base and expand direct
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relationships with customers. Other distributors may not be available
or may not agree to arrangements that are commercially reasonable. In the U.S. we could transition to direct customer purchase;
however, customers may not want to purchase directly from us and may decide to purchase competitors’ products through their distributors.
Moreover, a transition from distributors to direct customer purchase would be time consuming and costly.
Most of our components and raw materials, including all of our consumables
subassemblies, are sourced from single suppliers. If we are unable to obtain sufficient components or raw materials on a timely basis
or for a cost-effective price, or if we experience other supply difficulties, our business and results of operations may be adversely
affected.
Our ability to meet customer demand depends, in part, on our ability to
obtain timely and adequate delivery of raw materials and components for our products. A majority of the materials and components
that go into the manufacturing of our products, including all of our consumables subassemblies, are single-sourced from third-party suppliers.
The price and supply of materials and components for our products may be
impacted or disrupted for reasons beyond our control. A significant price increase from a single-source supplier could have a material
impact on our financial results. While we work with suppliers to ensure continuity of supply, no assurance can be given that these efforts
will be successful. Although we do carry strategic inventory and maintain insurance to help mitigate the potential risk related
to any supply disruption, there can be no assurance that such measures will be sufficient or effective. The termination, reduction
or interruption in supply of raw materials and components and an inability to quickly develop acceptable alternative sources for such
supply, could adversely impact our ability to manufacture and sell our products in a timely or cost-effective manner.
We do not have long-term agreements in place with any of our suppliers,
with the exception of an agreement with Command that expires December 31, 2026, subject to renewal. Due to regulatory requirements relating
to the qualification of suppliers, we are not likely to be able to establish additional or replacement sources on a timely basis or without
excessive cost. We are in the process of establishing alternative sources of supply for our raw materials and components, but there
can be no assurance we will be able to do so.
Additionally, volatility in our cost of energy, raw materials, components,
subassemblies, transportation/freight, and manufacturing and distribution could adversely affect our results of operations. Climate
change (including laws or regulations passed in response to it) could increase our costs, in particular our costs of supply, energy and
transportation/freight. Material or sustained increases in the price of oil and natural gas could have an adverse impact on the
cost of many of the plastic materials we use to make and package our products, as well as our transportation/freight costs. These
outcomes may in turn result in customers transitioning to available competitive products, loss of market share, negative publicity, reputational
damage, loss of customer confidence or other negative consequences (including a decline in stock price).
Interruption of our manufacturing or our contract manufacturing operations
could adversely affect our business.
Command currently provides subassemblies for all of our consumables (needle
and tubing sets), and manufactures, assembles and packages approximately 85% of our consumables. In the event of any interruption in Command’s
operations or supply of goods, the Company may have to seek alternative sources of subassemblies, which may be not be readily available
on commercially reasonable terms or at all, and increase its capacity for manufacturing finished goods in Mahwah, NJ, which could be time-consuming
and costly.
The FDA and other U. S. and non-U.S. government agencies regulate our manufacturing
and contract manufacturing operations for all of our products. Variations in our or Command’s manufacturing process may result in
production failures which could lead to launch delays, product shortage, unanticipated costs, lost revenues and damage to our reputation.
A failure to identify and address manufacturing problems prior to the release of products to our customers may also result in a
quality or safety issue that could result in a recall or other inability to sell our products.
Our products are currently manufactured in Nicaragua and Mahwah, NJ, and
stored in warehouse space at our corporate headquarters in Mahwah, NJ. Loss or damage to our manufacturing or contract manufacturing
and storage site due to weather, vandalism, terrorism, a natural disaster, issues in our manufacturing process, equipment failure or other
factors, could adversely affect our ability to manufacture sufficient quantities of products or otherwise deliver products to meet customer
demand or contractual requirements which may result in a loss of revenue and other adverse business consequences, including damage to
our relationship with customers. Additionally, because Command manufactures and supplies the Company’s subassemblies and finished
goods for needle sets and tubing products in Nicaragua, there could be a delay in providing the products timely due to their climate and
international boundaries. Command currently stores our finished goods in their warehouse located in Miami Florida once the products are
released from Nicaragua.
We take precautions to safeguard our facility, including acquiring insurance,
adopting health and safety protocols and utilizing off-site storage of computer data. Our insurance may not cover our losses in
any particular case. In addition, regardless of the level of insurance coverage, damage to our facility may harm our business, financial
condition and operating results.
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If we are unable to compete successfully in our highly competitive
industry, our business and financial condition may be adversely affected.
We operate in a single market – infusion – and are dependent
upon our success in that market. We face competition in our market from a wide range of international and domestic companies, including
those that deliver electronic volumetric pumps, elastomeric infuser pumps, other mechanical devices, novel drug delivery devices and methodologies,
and devices and formulation technologies that allow drugs to be delivered in volumes smaller than the FREEDOM System is designed to deliver.
These include large medical device companies with multiple product lines, some of which may have greater financial and marketing resources
than we do. We also face competition from companies that are even more specialized than ours with respect to particular markets
or product lines. Some of those companies have greater financial and sales and marketing resources than we do or offer products
at a lower price point than ours. In addition, former employees may develop products that are competitive with ours or capitalize
on customer relationships developed while employed with us, subject to their continuing obligations under confidentiality agreements and
other restrictive covenants that may survive their employment. We face competition on the basis of product features, clinical or
economic outcomes, product quality, availability, price, services, technological innovation and other factors. In addition, we face
changing customer preferences and requirements, changes in the ways healthcare services are delivered, including the transition of high-acuity
care to lower-acuity, and non-acute care settings.
Competition may increase further as additional companies begin to enter
our market or modify their existing products to compete directly with ours. If we are forced to reduce our prices due to increased
competition, our business could suffer.
The medical technology industry has also experienced a significant amount
of consolidation, resulting in larger companies with greater access to markets. Pharmaceutical manufacturers, healthcare systems,
other healthcare companies and even retail pharmacies are also consolidating, resulting in greater purchasing power for these companies.
As a result, competition among medical device suppliers to provide goods and services has increased. Group purchasing organizations
and integrated health delivery networks have also served to concentrate purchasing decisions for some customers, which has led to downward
pricing pressure for medical device suppliers. Further consolidation in the industry could intensify competition among medical device
suppliers and exert additional pressure on the prices of our products.
Consolidation in the medical industry could have a negative impact with
payor and provider relationships and distributor relationships, as we could lose market share as consolidation occurs.
Technological developments by others may disrupt our business and
negatively impact our revenues.
The medical device industry is subject to rapid technological change and
discovery and frequent product introductions. The development of new or improved products, processes or technologies by other companies
that provide better features, pricing or clinical outcomes or economic value may render our products or proposed products obsolete or
less competitive. If our competitors respond more quickly to new or emerging technologies and changes in customer requirements or
we do not introduce new versions or upgrades to our product portfolio in response to those requirements, our products may not be marketable.
If competitors develop more effective or affordable products or achieve earlier patent protection or product commercialization for
new products than we do, our operations will likely be adversely affected.
If a cybersecurity incident was to occur, it could cause substantial
disruption to our information systems and breaches of our security systems which could harm our business, customer relations and financial
condition.
We collect and store sensitive data in the regular course of business
on our networks and on third-party controlled applications. Such sensitive information includes our intellectual property and proprietary
business information, information about our customers, suppliers and business partners, and personally identifiable information of our
customers and employees. The secure processing, maintenance and transmission of this information is critical to our operations and business
strategy. Our information technology and infrastructure may be subject to cybersecurity attacks by hackers or breached due to human error,
malfeasance or other disruptions. Any such breach could compromise our networks and the information stored there could be accessed, publicly
disclosed, lost or stolen. Any such access, disclosure or other loss of information could result in legal claims or proceedings, liability
under laws that protect the privacy of personal information, regulatory penalties, disruption of our operations and the services we provide
to customers, and damage to our reputation and loss of confidence in our products and services, which could adversely affect our business,
operating margins, revenues and competitive position. In addition, the regulatory environment regarding data security and privacy evolves
frequently and has become increasingly restrictive.
We also use third-party information technology systems to store information,
interface with customers, maintain financial accuracy, secure our data and accurately produce our financial statements. If our information
technology systems do not effectively and securely collect, store, process and report relevant data for the operation of our business,
whether due to equipment malfunction or constraints, software deficiencies, human error or cyber incident, our ability to effectively
plan, forecast and execute our business plan and comply with applicable laws and regulations would be materially impaired. Any such impairment
could have a material adverse effect on our results of operations, financial condition and the timeliness in which we report our operating
results.
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Our insurance coverage related to information risks, breaches, and business interruption is subject to deductibles
and coverage limitations. We may not be able to maintain our current insurance coverage on acceptable terms, if at all, and, if available,
coverage may not be adequate to protect us against future claims. If we are unable to obtain insurance at an acceptable cost or on acceptable
terms or otherwise protect against such information risks and breach claims, we could be exposed to significant liabilities.
If we are unable to protect our patents or other proprietary rights,
or if we infringe the patents or other proprietary rights of others, our competitiveness and business prospects may be materially damaged.
Patent and other proprietary rights are essential to our business. We
own patents, trade secrets, trademarks and/or other intellectual property rights related to many of our products. Our success depends
to a significant degree on our ability to obtain and enforce patents, both in the U.S. and in other countries. We can lose the protection
afforded by these intellectual property assets through patent expirations, legal challenges or governmental action. Additionally,
our intellectual property rights may be challenged or infringed upon by third parties, particularly in countries where property rights
are not highly developed or protected, or we may be unable to enter into license agreements with third-party owners of intellectual property
on reasonable terms. Unauthorized use of our intellectual property rights or inability to preserve existing intellectual property
rights could adversely impact our competitive position and results of operations.
The patent position of a medical device company is often uncertain and
involves complex legal and factual questions. Significant litigation concerning patents and products is pervasive in our industry.
Patent claims include challenges to the coverage and validity of our patents on products or processes as well as allegations that
our products infringe patents held by competitors or other third parties. A loss in any of these types of cases could result in
a loss of patent protection or the ability to market products, which could lead to a significant loss of sales, or otherwise materially
affect future results of operations. We also rely on trademarks, trade secrets and know-how to develop, maintain and strengthen
our competitive positions. Third parties may know, discover or independently develop equivalent proprietary information or techniques,
or they may gain access to our trade secrets or disclose our trade secrets to the public.
Although our employees, consultants, parties to collaboration agreements
and other business partners are generally subject to confidentiality or similar agreements to protect our confidential and proprietary
information, these agreements may be breached, and we may not have adequate remedies in the event of a breach of confidence. To
the extent that our employees, consultants, parties to collaboration agreements and other business partners use intellectual property
owned by others in their work for us, disputes may arise as to the rights in related or resulting know-how and inventions.
Furthermore, our intellectual property, other proprietary technology and
other sensitive company data is potentially vulnerable to loss, damage or misappropriation from system malfunction, computer viruses,
unauthorized access to our data or misappropriation or misuse thereof by those with permitted access and other events. While we
have invested to protect our intellectual property, confidential information and other data, and continue to work diligently in this area,
there can be no assurance that our precautionary measures will prevent breakdowns, breaches, cyber incidents or other events. Such events
could have a material adverse effect on our reputation, business, financial condition or results of operations.
Misappropriation or other loss of our intellectual property from any of
the foregoing would have an adverse effect on our competitive position and may cause us to incur substantial litigation costs.
We need to attract and retain key employees to be competitive.
Our ability to compete effectively depends upon our ability to attract
and retain executives and other key employees, including people in technical, marketing, sales, research and development, quality assurance
and regulatory compliance positions. We depend on key management personnel and attracting and retaining other qualified personnel,
and our business could be harmed if we lose key management personnel or cannot attract and retain other qualified personnel. We
do not maintain any “key man” insurance policies on the lives of any of our employees.
The failure to attract, integrate, motivate, and retain skilled and qualified
personnel could have a material adverse effect on our business. We compete for such personnel against numerous companies, including
larger, more established companies with significantly greater financial resources than we possess. Our ability to recruit such talent
will depend on a number of factors, including compensation and benefits, work location and work environment. There can be no assurance
that we will be successful in attracting or retaining such personnel and the failure to do so could have a material adverse effect on
our business, financial condition and results of operations.
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Recent immigration enforcement actions in the U.S. could impact our operations
or the operations of our suppliers and vendors, and the ability to retain talented personnel.
Recent immigration enforcement by the U.S. government has resulted in increased
audits of our employment records, as well those of our suppliers and vendors, and the classification of employees, and may limit access
to visa programs for employees. Such changes may affect our ability, and the ability of our suppliers and vendors, to retain talent, increase
recruitment costs and affect innovation. We may be required to spend more time focusing on compliance with such immigration controls and
spend more costs on employment and immigration attorneys and human resources specialists to ensure compliance with U.S. government requirements.
Risks Related to Our Industry
Failure to obtain 510(k) clearance or PMA approval from the FDA for
our new products or enhancements to our existing products may affect our ability to grow our business.
In the U.S., our device products are subject to clearance or approval by
FDA under the FFDCA. Before we can market a new medical device, or a new use of, new claim for, or significant modification to,
an existing product, we must first receive either 510(k) clearance or approval of a PMA application from the FDA, unless an exemption
applies. Under the 510(k) process, the manufacturer must submit to the FDA a premarket notification, demonstrating that the device
is “substantially equivalent,” as defined in the statute, to a legally marketed predicate device. To be “substantially
equivalent,” the proposed device must have the same intended use as the predicate device, and either have the same technological
characteristics as the predicate device or have different technological characteristics and not raise different questions of safety or
effectiveness than the predicate device. If the manufacturer is unable to demonstrate substantial equivalence to FDA’s satisfaction,
or if there is no available predicate device, then the manufacturer may be required to seek approval through the PMA application process,
which is generally more costly and time consuming than the 510(k) process. Through the PMA application process, the applicant must
submit data and information demonstrating reasonable assurance of the safety and effectiveness of the device for its intended use. Accordingly,
a PMA application typically includes, but is not limited to, extensive technical information regarding device design and development,
pre-clinical and clinical trial data, manufacturing information, labeling and financial disclosure information for the clinical investigators
in device studies. In the future our device products may be approved as part of a drug submission under a combination product regulatory
pathway. Under the combination product approval process, our device would typically be submitted as part of a drug application, typically
a BLA or NDA in the United States. The proof required for approval as a combination product is similar to that required for a 510(k),
but may differ in material ways. In addition, the regulatory approval is held by the pharmaceutical manufacturer, not KORU.
We cannot guarantee that we will be able to obtain or maintain FDA 510(k)
clearance or premarket approval for our new products or enhancements or modifications to existing products (including the use of our FREEDOM
System with therapies not covered by the existing FDA clearance), and the failure to maintain approvals or clearances, or obtain approval
or clearance could have a material adverse effect on our business, results of operations, financial condition and cash flows. Even if
we are able to obtain approval or clearance, it may:
• take a significant amount of time
• require the expenditure of substantial resources
• involve modifications, repairs, or replacements of our products, and
• limit the proposed uses of our products.
Such increased costs and delays or failures associated with the clearance
and approval process and continuing review of approved products, could adversely affect our business, operating results and prospects.
There is no assurance that future clearance or approval of our new products or enhancements to our existing products will be granted,
or that we will be able to continue selling our products. Such failures could hurt our ability to maintain and grow our business.
Healthcare policy changes and industry cost-containment measures
could result in downward pricing pressure for our products and limit our sales.
Most of our customers, and those to whom our customers supply medical devices,
rely on third-party payers, including government programs and private health insurance plans, to reimburse some or all the cost of the
medical devices we manufacture. The continuing efforts of governmental authorities, insurance companies and other payers of healthcare
costs to contain or reduce these costs and, more generally, to reform the healthcare system, could limit the prices we are able to charge
for our products or the amounts of reimbursement available for our products or the drugs that they administer, which would put pressure
on us to reduce our prices for our products and/or limit our sales. The adoption of some or all of these proposals could have a
material adverse effect on our business, results of operations, financial condition and cash flows.
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Issues with product quality could have an adverse effect upon our
business, subject us to regulatory actions, cause a loss of customer confidence in us or our products, among other negative consequences.
Quality management plays an essential role in determining and meeting customer
requirements, preventing defects, improving our products and services, and assuring the safety and efficacy of our products. Our
future success depends on our ability to maintain and continuously improve our quality management program. While we have a quality
system that covers the lifecycle of our products, quality and safety issues may occur with respect to any of our products. A quality
or safety issue may result in adverse inspection reports, voluntary or official action indicated, warning letters, import bans, product
recalls (either voluntary or required by the FDA or similar governmental authorities in other countries) or seizures, monetary sanctions,
injunctions to halt manufacture and distribution of products, civil or criminal sanctions, costly litigation, refusal of a government
to grant approvals and licenses, restrictions on operations or withdrawal of existing approvals and licenses. An inability to address
a quality or safety issue in an effective and timely manner may also cause negative publicity, a loss of customer confidence in us or
our current or future products, which may result in the loss of sales and difficulty in successfully launching new products.
Defects or quality issues associated with our products could adversely
affect the results of our operations.
The design, manufacture and marketing of medical devices involve certain
inherent risks. Manufacturing or design defects, component failures, unapproved or improper use of our products, or inadequate disclosure
of risks or other information relating to the use of our products can lead to injury or other serious adverse events. We are subject
to the FDA’s medical device reporting regulations and similar foreign regulations, which require us to report to the FDA when we
receive or become aware of information that reasonably suggests that one or more of our products may have caused or contributed to a death
or serious injury or malfunctioned in a way that, if the malfunction were to recur, it could cause or contribute to a death or serious
injury. The timing of our obligation to report is triggered by the date we become aware of the adverse event as well as the nature
of the event. If we fail to comply with our reporting obligations, the FDA could take action, including warning letters, untitled
letters, administrative actions, criminal prosecution, imposition of civil monetary penalties, revocation of our device clearances or
approvals, seizure of our products, or delay in clearance or approval of future products.
These adverse events could also lead to safety alerts relating to our products
or recalls (either voluntary or as required by the FDA or similar governmental authorities in other countries), and could result, in certain
cases, in the removal of a product from the market. A recall could result in significant costs and lost sales and customers, enforcement
actions and/or investigations by state and federal governments or other enforcement bodies, as well as negative publicity and damage to
our reputation that could reduce future demand for our products. Any corrective action, whether voluntary or involuntary, as well
as defending ourselves in a lawsuit, will require the dedication of our time and capital, distract management from operating our business
and may harm our reputation and financial results.
Personal injuries relating to the use of our products can also result in
significant product liability claims being brought against us. A product liability claim, regardless of its merit or outcome, could
not only result in significant legal defense costs, but also have a material adverse effect on our business and reputation and ability
to attract and retain customers for our products. In some circumstances, adverse events could also cause delays in regulatory approval
of new products or the imposition of post-market approval requirements.
The therapeutic efficacy of certain of our biopharma customers’
products that may utilize our device are either unproven in humans or has only been proven in limited circumstances, and we may not be
able to successfully develop and sell our products in combination with our biopharma customers’ products.
While some of our biopharma customers use our products with established,
approved drugs, in certain instances, the benefits of those drugs as injectable therapies are either unproven or have only been proven
in limited circumstances. Our ability to generate revenue from our products will depend heavily on the successful development, commercialization
and sales of our biopharma customers’ products, which is subject to many potential risks. For example, data developed in clinical
trials or following the commercialization of our biopharma customers’ products may show that such therapies do not prove to be effective
treatments for the targets they are being designed to act against (or as effective as other treatments available). In clinical trials
or following commercialization, it may be shown that those drugs interact with human biological systems in unforeseen, ineffective or
harmful ways. If those drugs are associated with undesirable side effects or have characteristics that are unexpected, the pharmaceutical
companies that make those drugs may need to abandon clinical development or discontinue commercial sales or limit clinical development
or sales to certain uses or subpopulations in which the undesirable side effects or other characteristics are less prevalent, less severe
or more acceptable from a risk-benefit perspective. As a result of these and other risks described herein that are inherent in the
development and sale of therapeutic agents, pharmaceutical companies may never successfully develop or successfully commercialize their
drugs, or the commercialization of their drugs may be abandoned or severely limited, which may limit our profitability with respect to
biopharma customers with drugs or drug-device combination products including those drugs and our device, and we may not be successful
in achieving commercial scale production and sales of our injectable drug delivery systems in combination with certain drugs.
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Certain of the injectable therapies being targeted for use with our
products are not approved but are in various phases of clinical development. These injectable therapies may be independently terminated
by their makers prior to submission of a regulatory filing or even after regulatory approval and pharmaceutical developers may cease their
efforts with us, resulting in the cessation of any revenue associated with that contract or program.
We work with pharmaceutical and biotechnology companies who are targeting
the use of our products with a variety of injectable therapies. When we collaborate with pharmaceutical developers, they may engage
us in a variety of ways, including in vitro feasibility testing, product customization and validation (“development”),
non-interventional user testing of our devices, animal or human clinical research using our devices, regulatory submissions, manufacturing
development, and commercialization. Certain of those injectable therapies are not FDA approved and are in various phases of clinical development.
The clinical development of these pipeline therapies can be terminated by their developers at any stage. Our biopharma customers
may choose to continue their drug program without use of our devices. Use in one stage of work does not guarantee use in a future development
stage or in commercialization. Furthermore, these pharmaceutical companies could obtain regulatory approval for their injectable therapies
and decide for business reasons not to require or encourage utilization of our device. Prior investments we have made in manufacturing
capacity or research and development will then not result in the generation of revenue that would have previously been anticipated.
Our commercial success depends upon the attainment of significant
market acceptance of drug product candidates to be included in our biopharma customers’ products that may utilize our device, if
approved, among physicians, patients, healthcare payers or the medical community.
Even if biopharmaceutical companies obtain regulatory approval for their
drug product candidates, their product candidates may not gain sufficient levels of market acceptance among physicians, healthcare payers,
patients or the medical community to make them commercially feasible. Market acceptance of our biopharma customers’ product candidates,
if they receive approval, depends on a number of factors, including the:
• efficacy and safety of the product candidates;
• clinical indications for which the product candidates are approved;
• safety of the product candidates seen in a broader patient group;
• prevalence and severity of any side effects;
• cost of treatment in relation to alternative treatments;
• relative convenience and ease of administration; and
• effectiveness of the pharmaceutical companies’ sales and marketing efforts.
If pharmaceutical companies’ candidates are approved but fail to
achieve market acceptance among physicians, patients or healthcare payers, we may not be able to generate anticipated revenue. This
may limit our ability to generate anticipated revenue from our prior investments. Moreover, even if we achieve commercial scale
production and sales of our injectable drug delivery systems in combination with certain injectable therapies, the makers of such therapies
may face indirect competition from companies who develop and market other brand name, biosimilar or generic injectable therapies as well
as alternative treatments and delivery methods that compete with our biopharma customers’ products that may utilize our device,
which may have a material adverse effect on our results of operations, our financial condition and/or cash flows.
If coverage and reimbursement from third-party payors for procedures
utilizing our products are inadequate, adoption of our products will be adversely affected and our revenues and prospects for profitability
will suffer.
Purchasers of our products bill various third-party payors, including
governmental healthcare programs, such as Medicare, and private insurance plans, for procedures in which our products are used. Reimbursement
is a significant factor considered those purchasers in determining whether to acquire and utilize medical devices. Therefore, our ability
to successfully commercialize our products depends significantly on the adequacy of coverage and reimbursement from these third-party
payors.
Third-party payors, whether foreign or domestic, governmental or commercial,
are developing increasingly sophisticated methods of controlling healthcare costs. In addition, in the U.S., no uniform policy of coverage
and reimbursement for medical device products exists among third-party payors. Therefore, coverage and reimbursement for medical device
products can differ significantly from payor to payor. In addition, payors continually review new technologies for possible coverage
and can, without notice, deny coverage for these new products. As a result, the coverage determination process is often a time-consuming
and costly process that will require us to provide scientific and clinical support for the use of our products to each payor separately,
with no assurance that coverage and adequate reimbursement will be obtained or maintained if obtained.
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Reimbursement systems in international markets vary significantly by country and by region within some countries,
and reimbursement approvals must be obtained on a country-by-country basis. In many international markets, a product must be approved
for reimbursement before it can be approved for sale in that country. Further, many international markets have government-managed healthcare
systems that control reimbursement for new devices and procedures. In most markets, there are private insurance systems as well as government-managed
systems.
Most brand name injectable therapies will face future competition
from generic or biosimilar therapies, which could significantly reduce their commercial viability.
Brand name injectable therapies will usually become exposed to competition
from generic or biosimilar rivals at some time after their regulatory approval and commercial launch. The average selling price
and market share of brand name injectable therapies can be significantly diminished following the introduction of generic or biosimilar
competition. These factors may result in our biopharma customers using our products with their brand name injectable therapies seeking
to withdraw such injectable therapy from the market or change market tactics in a way that makes the use of our products cost prohibitive.
This may result in reduction of revenues due to lower demand, termination of supply contracts, and other factors.
Risks Related to Legal and Regulatory Compliance
We are subject to costly and complex laws and governmental regulations
and any adverse regulatory action may materially adversely affect our financial condition and business operations.
Our medical devices and technologies, as well as our business activities,
are subject to a complex set of regulations and rigorous enforcement, principally by the FDA, numerous other federal, state, and non-U.S.
governmental authorities and equivalent regulatory bodies of other countries. To varying degrees, each of these agencies requires
us to comply with laws and regulations governing the design, development, and manufacturing; testing, labeling, content and language of
instructions for use and storage; clinical trials; product safety; establishment registration and device listing; marketing, promotion,
and distribution of our products; premarket clearance and approval; record keeping procedures; advertising and promotion; recalls and
field safety corrective actions; post-market surveillance, including reporting of deaths or serious injuries and malfunctions that, if
they were to recur, could lead to death or serious injury; post-market approval studies; and product import and export.
Both before and after a product is commercially released, we have ongoing
responsibilities under the FDA and other applicable non-U.S. government agency laws and regulations. The FDA and other worldwide
regulatory agencies actively monitor compliance with local laws and regulations through review and inspection of design and manufacturing
practices, recordkeeping, reporting of adverse events, labeling and promotional practices. The results of these inspections can
include inspectional observations on the FDA’s Form 483, warning letters, or other forms of enforcement. If the FDA or any
state or foreign regulatory authorities were to conclude that we are not in compliance with any applicable laws or regulations, or that
any of our medical products are ineffective or pose an unreasonable health risk, they could deem our products adulterated or misbranded,
and take enforcement action against us. FDA and state and foreign regulatory authorities have broad enforcement powers. Possible
enforcement actions include, but are not limited to: temporarily or permanently suspending the sale and/or distribution of such
medical products; detaining or seizing all adulterated or misbranded medical products; ordering recall, repair, replacement, or refund
of such products; refusing to grant pending pre-market approval or 510(k) clearance applications; and/or requiring us to notify health
professionals and others that the devices present unreasonable risks of substantial harm to the public health. In addition, the
FDA prohibits device manufacturers from promoting their products for uses and indications other than those set forth in the approved product
labeling, and failure to comply with this prohibition could subject us to significant civil or criminal exposure, administrative obligations
and costs, and/or other potential penalties from, and/or agreements with, the federal government. The FDA and other non-U.S. government
agencies may also assess civil or criminal penalties against us, our officers or employees and impose operating restrictions on a company-wide
basis. The FDA may also recommend prosecution to the U.S. Department of Justice. Any adverse regulatory action, depending
on its magnitude, may restrict us from effectively marketing and selling our products and limit our ability to obtain future pre-market
clearances or approvals, and could result in a substantial modification to our business practices and operations.
Regulations regarding the development, manufacture and sale of medical
devices are evolving and subject to future change and have tended to become more stringent over time. Regulatory changes could result
in restrictions on our ability to continue or expand our operations, higher than anticipated costs, or lower than anticipated sales. We
cannot predict what impact, if any, those changes might have on our business; however, failure to comply with applicable regulatory requirements
could have a material adverse effect on our business, financial condition, and results of operations. Later discovery of previously
unknown problems with a product or manufacturer could result in fines, delays or suspensions of regulatory clearances or approvals, seizures
or recalls of products, physician advisories or other field actions, operating restrictions and/or criminal prosecution. We may
also initiate field actions as a result of a failure to strictly comply with our internal quality policies. The failure to receive
product approval clearance on a timely basis, suspensions of regulatory clearances, seizures or recalls of products, physician advisories
or other field actions, or the withdrawal of product approval by the FDA or by comparable agencies in foreign countries could have a material
adverse effect on our business, financial condition or results of operations.
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Governmental regulations outside the U.S. have also, and may continue to,
become increasingly stringent and common. Penalties for regulatory non-compliance could be severe, including fines and revocation
or suspension of a company’s EU device approval, ability to distribute products and criminal sanctions. Future foreign governmental
laws and regulations may have a material adverse effect on us.
In addition, exported devices are subject to the regulatory requirements
of each country to which the device is exported. Some countries do not have medical device regulations, but in most foreign countries,
medical devices are regulated. Frequently, regulatory approval may first be obtained in a foreign country prior to application in
the U.S. due to differing regulatory requirements; however, other countries, such as China for example, require approval in the country
of origin or legal manufacturer first. Most countries outside of the U.S. require that product approvals be renewed or recertified
on a regular basis, generally every four to five years. The renewal or recertification process requires that we evaluate any device
changes and any new regulations or standards relevant to the device and conduct appropriate testing to document continued compliance.
Where renewal or recertification applications are required, they may need to be renewed and/or approved in order to continue selling
our products in those countries. There can be no assurance that we will receive the required approvals for new products or modifications
to existing products on a timely basis or that any approval will not be subsequently withdrawn or conditioned upon extensive post market
study requirements.
Our global regulatory environment is becoming increasingly stringent and
unpredictable, which could increase the time, cost and complexity of obtaining regulatory approvals for our products, as well as the clinical
and regulatory costs of supporting those approvals. Several countries that did not have regulatory requirements for medical devices
have established such requirements in recent years and other countries have expanded on existing regulations. Certain regulators
are exhibiting less flexibility and are requiring local preclinical and clinical data in addition to global data. While harmonization
of global regulations has been pursued, requirements continue to differ significantly among countries. In the United Kingdom, for
example, the Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating the UK medical device market. With
recent changes in the United Kingdom’s membership with the European Union, the MHRA has and will continue to impose new regulatory
obligations for medical device manufacturers. We expect this global regulatory environment will continue to evolve, which could
impact our ability to obtain future approvals for our products or could increase the cost and time to obtain such approvals in the future.
We and the biopharmaceutical companies with whom we do novel therapies
business (“our biopharma customers”) are subject to extensive regulation by governments around the world, and if these regulations
are not complied with, existing and future operations may be curtailed, and we could be subject to liability.
Our devices and our biopharma customers’ products that may utilize
our device are subject to extensive regulation by governmental authorities in the United States, Europe and other countries, including
the FDA. Not only do these regulations present challenges during the regulatory approval process, but after our devices or our biopharma
customers’ products that may utilize our device are approved for new indications and placed in the market, numerous regulatory requirements
will apply. These include, but are not limited to QSR, labeling regulations and FDA prohibitions against the promotion of products
for uncleared, unapproved or “off label” uses, medical device reporting regulations and post-market surveillance regulations,
and laws and regulations that govern the development, testing, manufacturing, advertising, marketing and distribution of medical devices,
including our devices and our biopharma customers’ products that may utilize our device. The FDA has broad post-market and
regulatory enforcement powers.
If our devices are commercialized as part of a drug-delivery combination
product we, as the manufacturer of the device component of that combination product, we are subject to unannounced and preapproval inspections
by the FDA of our manufacturing facility to determine our compliance with QSR and cGMP.
Failure to comply with applicable regulatory requirements can result in
an enforcement action by the FDA or other regulatory authority, which may include any or all of the following sanctions: fines, injunctions,
consent decrees and civil penalties, recall or seizure of our products or our biopharma customers’ products, operating restrictions,
partial suspensions or total shutdown of production, refusing our biopharma customers’ requests for regulatory approvals of their
drug-device combination products or new intended uses, as applicable, refusing our requests for regulatory approval of our devices, withdrawing
our biopharma customers’ or our regulatory approvals that may be granted and criminal prosecution.
Our compliance with EU MDR regulations by December 2028 will require
significant investment and, if we are not in compliance by that time, we will not be able to sell our products in the EU.
In the European Union (“EU”), we are required to comply with
the new Medical Device Regulation (“MDR” or “EU MDR”) effective May 2021, which supersedes the prior Medical Device
Directives. Medical devices which have a valid CE certificate to the current Medical Device Directives (issued before May 2021), as do
all of our current products, can continue to be sold until December 2028 or until the CE certificate expires, whichever comes first, providing
there are no significant changes as defined in Article 120 of EU MDR.
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The MDR was published in May 2017 with a 3-year transition period.
That transition period was extended to May 2021 due to the COVID-19 pandemic. In early 2023, the transition period was further extended
to December 2028 for class IIa products. The CE mark required to sell medical devices in the EU is affixed following conformity
assessment and either approval from an appointed independent notified body or through self-certification by the manufacturer. The selected
pathway to CE marking is based on product risk classification. CE marking indicates conformity to the applicable essential requirements
of the relevant Medical Device Directives and in the future to the general safety and performance requirements for the new MDR. The MDR
will change multiple aspects of the existing regulatory framework for CE marking, such as increased clinical evidence requirements and
other new requirements, including Unique Device Identification (“UDI”) as well as many other post-market obligations. MDR
also significantly modifies and increases the compliance requirements for the industry and will require significant investment by us in
the near future to implement.
If we are unable to comply with the MDR by December 2028, we will not be
able to sell our products in the EU, which will materially impact our net revenues.
Our failure to comply with laws and regulations relating to reimbursement
of healthcare products may subject us to penalties and adversely impact our reputation, business, results of operations, financial condition
and cash flows.
Our devices are purchased principally by specialty pharmacies and ambulatory
service providers or hospitals that typically bill various third-party payers, such as governmental programs (e.g., Medicare, Medicaid
and comparable non-U.S. programs), private insurance plans and managed care plans, for the healthcare services provided to their patients.
The ability of those customers to obtain appropriate reimbursement from third-party payers for our products and the drugs they administer
is critical because it affects which products customers purchase and the prices they are willing to pay. As a result, our devices
are subject to regulation regarding quality and cost by U.S. governmental agencies, including the Centers for Medicare & Medicaid
Services (“CMS”), as well as comparable state and non-U.S. agencies responsible for reimbursement and regulation of healthcare
goods and services, including laws and regulations related to kickbacks, false claims, self-referrals and healthcare fraud. Many
states have similar laws that apply to reimbursement by state Medicaid and other funded programs, and in some cases to all payers. In
certain circumstances, insurance companies can attempt to bring a private cause of action against a manufacturer for causing a false claim
to be filed under the Federal Racketeer Influenced and Corrupt Organizations Act. In addition, as a manufacturer of FDA-approved devices
reimbursable by federal healthcare programs, we are subject to the Physician Payments Sunshine Act, which requires us to annually report
certain payments and other transfers of value we make to U.S.-licensed physicians or U.S. teaching hospitals. Any failure to comply
with these laws and regulations could subject us or our officers and employees to criminal and civil financial penalties. Similar
reporting requirements applicable to medical device manufacturers have also been implemented by some states. Failure to comply with these
state requirements could result in civil monetary penalties being assessed against us.
These laws and regulations, among other things, constrain our business,
marketing and other promotional activities by limiting the kinds of financial arrangements, including sales programs, we may have with
hospitals, physicians or other potential purchasers of our products. Due to the breadth of these laws, the narrowness of statutory exceptions
and regulatory safe harbors available, and the range of interpretations to which they are subject, it is possible that some of our current
or future practices might be challenged under one or more of these laws.
To enforce compliance with the healthcare regulatory laws, certain enforcement
bodies have recently increased their scrutiny of interactions between healthcare companies and healthcare providers, which has led to
a number of investigations, prosecutions, convictions and settlements in the healthcare industry. Responding to investigations can be
time-and resource-consuming and can divert management’s attention from the business. Additionally, as a result of these investigations,
healthcare providers and entities may have to agree to additional compliance and reporting requirements as part of a consent decree or
corporate integrity agreement. Any such investigation or settlement could increase our costs or otherwise have an adverse effect on our
business. Even an unsuccessful challenge or investigation into our practices could cause adverse publicity and be costly to respond
to. If our operations are found to be in violation of any of the healthcare laws or regulations described above or any other healthcare
regulations that apply to us, we may be subject to penalties, including administrative, civil and criminal penalties, damages, fines,
exclusion from participation in government healthcare programs, such as Medicare and Medicaid, imprisonment, contractual damages, reputational
harm, disgorgement and the curtailment or restructuring of our operations. In addition, we are subject to the U.S. Foreign Corrupt
Practices Act and similar anti-corruption laws outside the U.S. Actual or alleged violation of these laws by our employees, consultants,
sales agents or distributors could subject us to investigations by the U.S. or foreign governments, significant criminal or civil sanctions
and other liabilities, and damage our reputation.
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Risks Related to Economic Conditions
Our distribution network and other operations outside the U.S. subject
us to certain risks.
Approximately 26% of our net revenues in the year ended December 31, 2025,
came from our operations outside the U.S., and we intend to continue to pursue growth opportunities in foreign markets. Our foreign
operations subject us to certain risks, including, among others, the effects of fluctuations in foreign currency exchange, uncertainties
with respect to local economic and political conditions, competition from local companies, trade protectionism and restrictions on the
transfer of goods across borders, including tariffs or other barriers to market participation, pricing pressure that we may experience
internationally, U.S. diplomatic and trade relations with the governments of the foreign countries in which we operate,
foreign regulatory requirements or changes in such requirements, local product preferences and product requirements, longer payment terms
for accounts receivable than we experience in the U.S., difficulty in establishing, staffing and managing foreign operations, changes
to international trade agreements and treaties, changes in tax laws, weakening or loss of the protection of intellectual property rights
in some countries, and import or export licensing requirements.
There may be greater uncertainty and market volatility following U.S. and
global elections, resulting from potential shifts in trade policies, tariffs or other trade protection measures, and the reaction of other
countries thereto, or changes to international trade agreements, which could have a material adverse effect on our operations, including
our ability to source and manufacture products in a timely and cost effective manner, financial condition, results of operations and/or
liquidity. Geopolitical developments related to various global conflicts are sources of uncertainty and may cause disruptions to global
or regional markets, supply chains or operations in the regions. Such global conflicts include, but are not limited to, Russia’s
invasion of Ukraine in 2022, uncertainty in the Middle East region, increasing tensions between China and Taiwan, and U.S. military operations
in Venezuela. Sanctions and export restrictions may continue to proliferate, leading to greater uncertainty in emerging and growth markets.
Any significant changes in the political, economic, financial, competitive, legal and regulatory or reimbursement conditions where we
conduct, or plan to expand, our international operations may have a material impact on our business, financial condition or results of
operations.
Rising inflation increases economic uncertainty and may require us
to raise prices in order to maintain our operating margins.
For much of the past two years, inflation rates have risen or held steady
at rates not seen in a generation or more. Higher level of inflation not only reduces the real value of the profits we generate from
our business (and in turn our returns to investors), but it also increases the costs of goods and services, including those from our
single-source suppliers, that we need to run our business. Should such trends continue, it would not only have a destabilizing macroeconomic
effect on the broader U.S. and global economy, but it may also require us to increase the price of our products in order to maintain
sufficient operations margins. Any increase in the prices we charge our customers could reduce the demand for our products, perhaps significantly.
We will continue to monitor inflation trends and will make adjustments to our business as necessary.
We are subject to foreign currency exchange risk.
A portion of our revenues is currently, and we expect in the future to
be, derived from international operations. Our revenues from sales outside the U.S. may be adversely affected by fluctuations in
foreign currency exchange rates. We cannot predict with any certainty changes in foreign currency exchange rates or our ability
to mitigate these risks. We may experience additional volatility as a result of inflationary pressures and other macroeconomic factors.
If we cannot adequately mitigate foreign currency exchange rates, our revenues and profit may suffer.
A government shutdown may have a material adverse impact on our business
and results of operations.
The Company is subject to various federal regulations and various federal
agency oversight. A government shutdown or understaffing at applicable federal agencies could result in unforeseen delays despite compliance
with these regulations and federal agency requirements. Such a delay could materially and adversely affect the Company’s results
of operations, cash flows and liquidity.
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A downturn in global economic conditions in government-sponsored
healthcare systems could adversely affect our operations.
Deterioration in the global economic environment, particularly in countries
with government-sponsored healthcare systems, may cause decreased demand for our products and increased competition, which could result
in lower sales volume, lower end-user demand through changes to payor reimbursement, and downward pressure on the prices for our products,
longer sales cycles, and slower adoption of new technologies. A weakening of economic conditions in the U.S. and/or abroad may also adversely
affect our suppliers, which could result in interruptions in supply. Further, sanctions, tariffs, or other measures that restrict international
trade, as well as instability resulting from global conflicts, could negatively affect our business operations and results.
Public health crises, such as the COVID-19 pandemic, have had, and