3 unchanged sentences
Additional risks and uncertainties not currently known to UTMD or currently deemed to be immaterial also may materially adversely affect the Company’s business, financial condition and/or operating results.
−Removed: Legislative or executive order healthcare reform in the United States , particularly as suggested by leading candidates in a presidential election year, have the potential to render the U.S.
+Added: Legislative or executive order healthcare interference in the United States renders the U.S.
medical device marketplace unpredictable.
A fully government-run healthcare system would likely eliminate healthcare consumer choice as well as commercial incentives for innovation.
−Removed: Government-mandated shutdowns of “nonessential” medical procedures with the intent of protecting the public from a virus have the potential to substantially reduce demand for UTMD’s medical devices.
+Added: Restrictions on “nonessential” medical procedures during a pandemic reduce the demand for certain of UTMD’s medical devices.
Increasing regulatory burdens, including premarketing approval delays, may result in significant loss of revenue, unpredictable costs and loss of management focus on developing and marketing products that improve the quality of healthcare:
2 unchanged sentences
The risks associated with such circumstances relate not only to substantial out-of-pocket costs, including potential litigation in millions of dollars, but also loss of business and a diversion of attention of key employees for an extended period of time from managing their normal responsibilities, particularly in new product development and routine quality assurance activities.
−Removed: The dominance of Group Purchasing Organizations (GPOs) adds non-productive costs, typically weakens the Company’s marketing and sales efforts and may result in lower revenues:
+Added: Group Purchasing Organizations (GPOs) add non-productive costs, weaken the Company’s marketing and sales efforts and cause lower revenues by restricting access:
GPOs, theoretically acting as bargaining agents for member hospitals, but actually collecting revenues from the companies that they are negotiating with, have made a concerted effort to turn medical devices that convey special patient safety advantages and better health outcomes, like UTMD’s, into undifferentiated commodities.
GPOs have been granted an antitrust exemption by the U.S.
−Removed: Their business model based on “kickbacks” would be a violation of law in any other industry.
−Removed: These bureaucratic entities do not recognize or understand the overall cost of care as it relates to safety and effectiveness of devices, and they create a substantial administrative burden that is primarily driven by collection of administrative fees.
+Added: Otherwise, their business model based on “kickbacks” would be a violation of law.
+Added: Despite rhetoric otherwise, these bureaucratic entities do not recognize or understand the overall cost of care as it relates to safety and effectiveness of devices, and they create a substantial administrative burden that is primarily driven by collection of administrative fees.
The Company’s business strategy may not be successful in the future:
−Removed: As the level of complexity and uncertainty in the medical device industry increases, evidenced, for example, by the unpredictable regulatory environment, the Company’s views of the future and product/ market strategy may not yield financial results consistent with the past.
+Added: As the level of complexity and uncertainty in the medical device industry increases, evidenced, for example, by the unpredictable and overly cumbersome regulatory environment, the Company’s views of the future and product/ market strategy may not yield financial results consistent with the past.
As the healthcare industry becomes increasingly bureaucratic it puts smaller companies like UTMD at a competitive disadvantage:
8 unchanged sentences
The Company’s reliance on third party distributors in some markets may result in less predictable revenues:
−Removed: UTMD’s distributors have varying expertise in marketing and distributing specialty medical devices.
+Added: UTMD’s distributors have varying expertise in marketing and selling specialty medical devices.
They also sell other devices that may result in less focus on the Company’s products.
10 unchanged sentences
made raw materials and components are likely being purchased in fixed USD.
+Added: Trade restrictions and /or tariffs resulting from changing government trade policies have the potential to disrupt UTMD’s supply chain.
+Added: The corona virus pandemic could potentially disrupt UTMD’s supply chain or interfere with normal business operations due to the loss of employee availability.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.