Content analysis
?Positive | ||
Negative | ||
Uncertain | ||
Constraining | ||
Legalese | ||
Litigous | ||
Readability |
H.S. sophomore Avg
|
Financial report summary
?Risks
- Risks Relating to Our Business
- We are subject to a variety of risks due to our international operations and continued global expansion.
- We operate in highly competitive market segments, face competition from large, well-established medical device companies and tissue service providers with greater resources and we may not be able to compete effectively.
- We are significantly dependent on our revenues from tissue preservation services and are subject to a variety of risks affecting them.
- We are significantly dependent on our revenues from BioGlue and are subject to a variety of related risks.
- We are significantly dependent on our revenues from On-X products and are subject to a variety of related risks.
- Continued fluctuation of foreign currencies relative to the US Dollar could materially, adversely affect our business.
- Our charges resulting from acquisitions, restructurings, and integrations may materially, adversely affect the market value of our common stock.
- Public health crises have, may continue to have, and could have a material, adverse impact on us.
- We are heavily dependent on our suppliers and contract manufacturers to provide quality products.
- We are dependent on single and sole-source suppliers and single facilities.
- We are dependent on our specialized workforce.
- We continue to evaluate expansion through acquisitions of, or licenses with, investments in, and distribution arrangements with, other companies or technologies, which may carry significant risks.
- We may not realize all the anticipated benefits of our business development activities.
- We may not realize all the anticipated benefits of our corporate rebranding and it may result in unanticipated disruptions to our on-going business.
- Significant disruptions of information technology systems or breaches of information security systems could adversely affect our business.
- Our products and tissues are highly regulated and subject to significant quality and regulatory risks.
- Reclassification by the FDA of CryoValve SG pulmonary heart valve (“CryoValve SGPV”) may make it commercially infeasible to continue processing the CryoValve SGPV.
- We may not be successful in obtaining clinical results or regulatory clearances/approvals for new and existing products and services, and our approved products and services may not achieve market acceptance.
- Increased regulatory enforcement activities and private litigation activity relating to processes and materials used in our industry could have a material, adverse impact on us.
- We may be subject to fines, penalties, and other sanctions if we are deemed to be promoting the use of our products for unapproved, or off-label, uses.
- Healthcare policy changes may have a material, adverse effect on us.
- As a medical device manufacturer and tissue services provider we are exposed to risk of product liability claims and our existing insurance coverage may be insufficient, or we may be unable to obtain insurance in the future, to cover any resulting liability.
- We are subject to various US and international bribery, anti-kickback, false claims, privacy, transparency, and similar laws, any breach of which could cause a material, adverse effect on our business, financial condition, and profitability.
- The proliferation of new and expanded data privacy laws, including the General Data Protection Regulation in the European Union, could adversely affect our business.
- Some of our products and technologies are subject to significant intellectual property risks and uncertainty.
- The agreements governing our indebtedness contain restrictions that limit our flexibility in operating our business.
- Our indebtedness could adversely affect our ability to raise additional capital to fund operations and limit our ability to react to changes in the economy or our industry.
- We have pledged substantially all of our US assets as collateral under our existing Credit Agreement. If we default on the terms of such credit agreements and the holders of our indebtedness accelerate the repayment of such indebtedness, there can be no assurance that we will have sufficient assets to repay our indebtedness.
- Our business could be negatively impacted as a result of shareholder activism.
- Our business could be impacted by increased shareholder emphasis on environmental, social, and governance matters or efforts by certain governmental authorities to reduce such emphasis.
- We do not anticipate paying any dividends on our common stock for the foreseeable future.
- Provisions of Delaware law and anti-takeover provisions in our organizational documents may discourage or prevent a change of control, even if an acquisition would be beneficial to shareholders, which could affect our share price adversely and prevent attempts by shareholders to remove current management.
Management Discussion
- Revenues increased 13% for the twelve months ended December 31, 2023, as compared to the twelve months ended December 31, 2022. The increase in revenues for the twelve months ended December 31, 2023 was due to an increase in revenues from aortic stent grafts, On-X products, preservation services, other products, and surgical sealants. Excluding the effects of foreign exchange, revenues increased 12% for the twelve months ended December 31, 2023, as compared to the twelve months ended December 31, 2022. Revenues for the twelve months ended December 31, 2022 were negatively impacted in certain regions by delays or cancellations of some surgical procedures as a result of reduced hospital capacity and staffing and hospital restrictions due to the COVID-19 pandemic and local labor disputes.