We expect that as we increase our materials acquisition levels for domestic production, we will be able to achieve economies of scale and greater volume-purchasing agreements with our suppliers, but there is no guarantee such benefits will materialize. 8 Table of Contents Vaccine Hesitancy Could Impact Demand Overall demand may be affected by public sentiment and acceptance of the safety and efficacy of vaccinations.
We expect that as we increase our materials acquisition levels for domestic production, we will be able to achieve economies of scale and greater volume-purchasing agreements with our suppliers, but there is no guarantee such benefits will materialize. Vaccine Hesitancy Could Impact Demand Overall demand may be affected by public sentiment and acceptance of the safety and efficacy of vaccinations.
In the event of a resurgence of COVID-19 or in the case of any future pandemic, there is no guarantee that revenues from syringes needed for vaccines would offset the effects to our business of a global economic decline. 9 Table of Contents Travel and import restrictions may also disrupt our ability to manufacture or distribute our products.
In the event of a resurgence of COVID-19 or in the case of any future pandemic, there is no guarantee that revenues from syringes needed for vaccines would offset the effects to our business of a global economic decline. Travel and import restrictions may also disrupt our ability to manufacture or distribute our products.
Because 25.1% of our total assets are invested in the market, fluctuations in market values could have a material adverse impact on our business, financial condition, results of operations, or cash flows.
Because 24.1% of our total assets are invested in the market, fluctuations in market values could have a material adverse impact on our business, financial condition, results of operations, or cash flows.
Health Crises Could Have an Adverse Effect on Our Business In any future health crisis, we may elect or be required to close temporarily which would result in a disruption in our activities and operations. Our supply chain, including transportation channels, may be impacted by any such restrictions as well. Any such disruption could impact our sales and operating results.
Health Crises Could Have an Adverse Effect on Our Business In any future health crisis, we may elect or be required to close temporarily which would result in a disruption in our activities and operations. Our supply chain, including transportation channels, may be impacted by any such restrictions as well.
As such, independent of the rights granted to Mr. Shaw under the Amendment, as beneficial owner of 53.3% of our stock and Chairman of the Board, Mr. Shaw has considerable influence on all business combination decisions.
As such, independent of the rights granted to Mr. Shaw under the Amendment, as beneficial owner of 55.7% of our stock and Chairman of the Board, Mr. Shaw has considerable influence on all business combination decisions.
Even with increased domestic production, we may not be able to avoid a disruption in supply. We derived 11.1% of our revenues in 2024 from international sales. International sales, particularly in emerging market countries, are further subject to a variety of regulatory, economic, and political risks as well.
Even with increased domestic production, we may not be able to avoid a disruption in supply. We derived 15.8% of our revenues in 2025 from international sales. International sales, particularly in emerging market countries, are further subject to a variety of regulatory, economic, and political risks as well.
We are dependent on patent rights, and if the patent rights are invalidated or circumvented, our business would be adversely affected. Patent protection is considered, in the aggregate, to be of material importance in the design, development, and marketing of our products. Syringes comprised 68.5% of sales in 2024.
We are dependent on patent rights, and if the patent rights are invalidated or circumvented, our business would be adversely affected. Patent protection is considered, in the aggregate, to be of material importance in the design, development, and marketing of our products. Syringes comprised 65.1% of sales in 2025.
With resources greatly in excess of our own, we expect Embecta will be a formidable competitor. 7 Table of Contents We Are Controlled by One Shareholder Thomas J. Shaw, our President and Chief Executive Officer, has investment or voting power over a total of 53.3% of the outstanding Common Stock as of March 10, 2025. Mr.
With resources greatly in excess of our own, we expect Embecta will be a formidable competitor. We Are Controlled by One Shareholder Thomas J. Shaw, our President and Chief Executive Officer, has investment or voting power over a total of 55.7% of the outstanding Common Stock as of March 9, 2026. Mr.
Any disruption in our suppliers’ operations or timely availability of shipments from our third-party freight carriers could disrupt our ability to provide product to our customers in a timely manner, which could materially and adversely affect our results of operations and cash flows. Inflationary Price Pressures and Uncertain Availability of Commodities, Raw Materials, Utilities, Labor or Other Inputs Used by us and our Suppliers, or Instability in Logistics and Related Costs, Could Negatively Impact our Profitability Increases in the price of commodities, raw materials, utilities, labor or other inputs that we or our suppliers use in manufacturing and supplying products, components and parts, along with logistics and other related costs, may lead to higher production and shipping costs for our products, parts, and components.
Any disruption in our suppliers’ operations or timely availability of shipments from our third-party freight carriers could disrupt our ability to provide product to our customers in a timely manner, which could materially and adversely affect our results of operations and cash flows. Geopolitical conflicts, including ongoing tensions in the Middle East, could disrupt our supply chain and limit the timely availability of components or finished goods, which could materially and adversely affect our results of operations and cash flows. 7 Table of Contents Inflationary Price Pressures and Uncertain Availability of Commodities, Raw Materials, Utilities, Labor or Other Inputs Used by us and our Suppliers, or Instability in Logistics and Related Costs, Could Negatively Impact our Profitability Increases in the price of commodities, raw materials, utilities, labor or other inputs that we or our suppliers use in manufacturing and supplying products, components and parts, along with logistics and other related costs, may lead to higher production and shipping costs for our products, parts, and components.
We could be subject to risks associated with doing business outside of the U.S, including risks associated with global economic, regulatory, or political changes, or health crises. Current or worsening economic conditions may adversely affect our business and financial condition.
We could be subject to risks associated with doing business outside of the U.S, including risks associated with global economic, regulatory, or political changes, or health crises. Current or worsening economic conditions may adversely affect our business and financial condition. 9 Table of Contents Item 1B. Unresolved Staff Comments. Not applicable and none.
Among the political risk we face with regard to international sales is the risk that our products may be subject to reciprocal tariffs in foreign countries in reaction to recently enacted and threatened tariffs by the U.S.
Among the political risk we face with regard to international sales is the risk that our products may be subject to reciprocal tariffs in foreign 5 Table of Contents countries in reaction to recently enacted and threatened tariffs by the U.S. The overall risk to our successful efforts in international markets is unknown and difficult to predict.
Though newly formed, Embecta licenses existing BD intellectual property and has continued to use the BD branding on its products and is provided with certain other services by BD. Embecta’s 2024 annual report indicated that the company had 2,100 employees, as compared to our workforce of 227 employees.
(“Embecta”) in April 2022. Embecta licenses existing BD intellectual property and has continued to use the BD branding on its products and is provided with certain other services by BD. Embecta’s 2025 annual report indicated that the company had 1,850 employees, as compared to our workforce of 201 employees.
In 2024, we used Chinese manufacturers to produce 83.9% of our products. Recently enacted tariffs on our products are expected to have a material negative impact to our results of operations and financial position.
In 2025, we used Chinese manufacturers to produce 62.6% of our products. Tariffs on our products continue to have a material negative impact to our results of operations and financial position.
These competitors may be able to use these resources to improve their products through research and acquisitions or develop new products which may compete more effectively with our products. If our competitors choose to use their resources to create products superior to ours, we may be unable to sell our products and our ability to continue operations would be weakened.
These competitors may be able to use these resources to improve their products through research and acquisitions or develop new products which may compete more effectively with our products.
A material increase in the cost of inputs to our production could lead to higher costs for our products and could negatively impact our operating results. The full impact of greater domestic production on our sourcing materials through our supply chain is not yet known and difficult to estimate.
A material increase in the cost of inputs to our production could lead to higher costs for our products and could negatively impact our operating results.
However, we have recently adapted some equipment to increase our domestic manufacturing capabilities. While we are committed to decreasing our reliance on imported products, and decreasing the negative financial impact such tariffs carry, there is no guarantee that our efforts will be successful.
Notwithstanding our efforts to shift the majority of our manufacturing to our domestic facility, we are still reliant on our Chinese manufacturers to provide products we are not able to manufacture. While we are committed to decreasing our reliance on imported products, and decreasing the negative financial impact such tariffs carry, there is no guarantee that our efforts will be successful.
We are working to lessen the financial impact of the tariffs, including shifting a larger portion of manufacturing of 1mL, 3mL, and EasyPoint ® needles to our domestic manufacturing facility, but these actions are expensive, and the timeline remains uncertain. In addition, the tariffs implemented in 2025 are expanded beyond the original 2024 tariffs placed on syringes and needles.
We are working to lessen the financial impact of the tariffs, including shifting a larger portion of manufacturing of 1mL, 3mL, and EasyPoint ® needles to our domestic manufacturing facility.
For instance, Becton, Dickinson and Company (“BD”), a global company which we had previously considered our primary competitor, spun off a portion of its syringe, needle, and injection product division as Embecta Corp. (“Embecta”) in April 2022.
If our competitors choose to use their resources to create products superior to ours, we may be unable to sell our products and our ability to continue operations would be weakened. 6 Table of Contents For instance, Becton, Dickinson and Company (“BD”), a global company which we had previously considered our primary competitor, spun off a portion of its syringe, needle, and injection product division as Embecta Corp.
Widespread health crises also negatively affect economies which could affect demand for our products.
Any such disruption could impact our sales and operating results. 8 Table of Contents Widespread health crises also negatively affect economies which could affect demand for our products.
While some products in our catalog of products are unrelated to the administration of vaccines, changes in the acceptance of vaccinations could have a material impact on our business. We Face Inherent Product Liability Risks As a manufacturer and provider of safety needle products, we face an inherent business risk of exposure to product liability claims.
Centers for Disease Control and Prevention (CDC) may negatively impact demand for our products used in vaccine administration. We Face Inherent Product Liability Risks As a manufacturer and provider of safety needle products, we face an inherent business risk of exposure to product liability claims.
The overall risk to our successful efforts in international markets is unknown and difficult to predict. 6 Table of Contents We Are Concerned that Our Stock Price is Not Correlated with Value As of December 31, 2024, our market capitalization was $20.7 million (based on a $0.69 per share closing price) and total stockholders’ equity was $87.2 million.
We Are Concerned that Our Stock Price is Not Correlated with Value As of December 31, 2025, our market capitalization was $23.1 million (based on a $0.77 per share closing price) and total stockholders’ equity was $74.4 million. Our stock price reached a low of $0.62 per share in 2025 despite our strong balance sheet.
If a superior technology is created, the demand for our products could greatly diminish. Our Competitors Have Greater Resources Our competitors have greater financial resources, larger and more established sales and marketing and distribution organizations, and greater market influence, including long-term contracts.
Any such changes could materially and adversely affect our net sales, margins, financial condition, results of operations, and cash flows. Our Competitors Have Greater Resources Our competitors have greater financial resources, larger and more established sales and marketing and distribution organizations, and greater market influence, including long-term contracts.