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. 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.
In addition, diversion of products into other channels may result in reduced revenues. 9 Table of Contents General Risk Factors We face risk factors common to other U.S. businesses. We could be subject to complex and costly regulation. Our business could suffer if we or our suppliers encounter manufacturing problems or disruptions to transportation channels.
In addition, diversion of products into other channels may result in reduced revenues. General Risk Factors We face risk factors common to other U.S. businesses. We could be subject to complex and costly regulation. Our business could suffer if we or our suppliers encounter manufacturing problems or disruptions to transportation channels.
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.
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.
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 2022 annual report indicated that the company had 1,900 employees, as compared to our workforce of less than 200 employees.
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 2023 annual report indicated that the company had 2,200 employees, as compared to our workforce of less than 200 employees.
Even with increased domestic production, we may not be able to avoid a disruption in supply. Trade protection measures, including tariffs, and/or changes to import or export requirements could materially adversely impact our operations. We cannot predict the impact of potential changes to U.S. foreign trade policy. Additionally, we derived 44.9% of our revenues in 2022 from international sales.
Even with increased domestic production, we may not be able to avoid a disruption in supply. Trade protection measures, including tariffs, and/or changes to import or export requirements could materially adversely impact our operations. We cannot predict the impact of potential changes to U.S. foreign trade policy. Additionally, we derived 20.6% of our revenues in 2023 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 Controlled by One Shareholder Thomas J. Shaw, our President and Chief Executive Officer, has investment or voting power over a total of 51.4% of the outstanding Common Stock as of March 10, 2023. Mr.
International sales, particularly in emerging market countries, are further subject to a variety of regulatory, economic, and political risks as well. We Are Controlled by One Shareholder Thomas J. Shaw, our President and Chief Executive Officer, has investment or voting power over a total of 50.8% of the outstanding Common Stock as of March 11, 2024. Mr.
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. VanishPoint ® syringes comprised 91.5% of sales in 2022.
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 78.3% of sales in 2023.
With resources greatly in excess of our own, we expect Embecta will be a formidable competitor. Operations May Be Affected by Foreign Trade Policy We are subject to risks associated with foreign trade policy. In 2022, we used Chinese manufacturers to produce 91.6% of our products.
With resources greatly in excess of our own, we expect Embecta will be a formidable competitor. 6 Table of Contents Operations May Be Affected by Foreign Trade Policy We are subject to risks associated with foreign trade policy. In 2023, we used Chinese manufacturers to produce 88.4% of our products.
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. Item 1B. Unresolved Staff Comments. Not applicable and none.
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.
Item 1A. Risk Factors. You should carefully consider the following material risks facing us. If any of these risks occur, our business, results of operations, or financial condition could be materially affected. We Are Concerned that Our Stock May Be Manipulated As previously disclosed, we are concerned there may be manipulation of our stock.
Item 1A. Risk Factors. You should carefully consider the following material risks facing us. If any of these risks occur, our business, results of operations, or financial condition could be materially affected.
Shaw has considerable influence on all business combination decisions. 7 Table of Contents Supply Chain Disruptions Could Negatively Impact our Profitability Our operations are dependent upon timely delivery of finished goods from our Chinese manufacturers and timely delivery of sufficient quantities of components and raw materials for domestic manufacturing.
Supply Chain Disruptions Could Negatively Impact our Profitability Our operations are dependent upon timely delivery of finished goods from our Chinese manufacturers and timely delivery of sufficient quantities of components and raw materials for domestic manufacturing.
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.
Widespread health crises also negatively affect economies which could affect demand for 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.
Any import or export or other cargo restrictions related to our products or the raw materials used to manufacture our products could restrict our ability to manufacture and ship products and harm our business, financial condition, and results of operations.
Any import or export or other cargo restrictions related to our products or the raw materials used to manufacture our products could restrict our ability to manufacture and ship products and harm our business, financial condition, and results of operations. 8 Table of Contents Our key personnel and other employees could be affected by COVID-19 or any future pandemic, which could affect our ability to operate efficiently.
As such, independent of the rights granted to Mr. Shaw under the Amendment, as beneficial owner of 51.4% of our stock and Chairman of the Board, Mr.
As such, independent of the rights granted to Mr. Shaw under the Amendment, as beneficial owner of 50.8% of our stock and Chairman of the Board, Mr. Shaw has considerable influence on all business combination decisions.
These competitors may be able to use these 6 Table of Contents resources to improve their products through research and acquisitions or develop new products, which may compete more effectively with our products.
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.
As of December 31, 2022, our market capitalization was $49.1 million (based on a $1.64 per share closing price) and total stockholders’ equity was $108 million. Our Customers Have Excess Product In Inventory and We Cannot Predict When It Will Be Depleted We believe domestic customers have retained Retractable products purchased or provided for vaccination purposes in inventory, leading to a decrease in demand for our products.
Our stock price reached a low of $0.95 per share in 2023 despite our strong balance sheet. Our Customers Have Excess Product In Inventory and We Cannot Predict When It Will Be Depleted We believe domestic customers have retained Retractable products (as well as competitive products) purchased or provided for vaccination purposes in inventory, leading to a decrease in demand for our products.
Because 15.2% 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. 8 Table of Contents 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.
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.
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. Our Stock Has Recently Experienced Significant Price Fluctuation Our stock price experienced significant fluctuation during 2022 and may continue to be unpredictable.
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. 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.