In addition to other information set forth in this report, readers should carefully consider the factors discussed in Part I, Item 1A.
−Removed: "Risk Factors"
−Removed: of the 2022 Annual Report on Form 10-K, as updated and supplemented below.
+Added: "Risk Factors" of our 2023 Annual Report on Form 10-K.
Any of the risk factors disclosed in our reports could materially affect our business, financial condition or future results.
−Removed: The risks described here and in our 2022 Annual Report on Form 10-K are not the only risks we face.
+Added: The risks described in our 2023 Annual Report on Form 10-K are not the only risks we face.
Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially and adversely affect our business, financial condition and/or operating results.
−Removed: The discussion of the risk factors below updates the corresponding disclosure under the same headings in the 2022 Annual Report on Form 10-K and may contain material changes to the corresponding risk factor discussion in our 2022 Annual Report on Form 10-K.
−Removed: Our international operations make us subject to the U.S.
−Removed: Foreign Corrupt Practices Act and similar anti-bribery laws in non-U.S.
−Removed: jurisdictions, and our failure, or the failure of our distributors and agents, to comply with these laws could subject us to civil and criminal penalties and adversely affect our business.
−Removed: We currently conduct our business in various foreign countries, and we expect to continue to expand our foreign operations.
−Removed: As a result, we are subject to the U.S.
−Removed: Foreign Corrupt Practices Act (“FCPA”), the U.K.
−Removed: Bribery Act, and similar anti-corruption laws in non-U.S.
−Removed: jurisdictions.
−Removed: These laws generally prohibit companies and their intermediaries from illegally offering things of value to any individual for the purpose of obtaining or retaining business.
−Removed: Compliance with the FCPA and other anti-bribery laws presents challenges to our operations.
−Removed: Our policies mandate compliance with the FCPA and all other applicable anti-bribery laws.
−Removed: Further, we expect our employees, distributors, agents and others who work for us or on our behalf to comply with these anti-bribery laws.
−Removed: Despite our training and compliance programs, our internal control policies and procedures may not always protect us from reckless or criminal acts committed by our employees, distributors or agents.
−Removed: If our employees, distributors or agents violate the provisions of the FCPA or other anti-bribery laws, or even if there are allegations of such violations, we could be subject to investigations or civil and criminal penalties or other sanctions, which could have a material adverse effect on our reputation, business, results of operations, financial condition or cash flows.
−Removed: As disclosed in Note 10 “Commitments and Contingencies” to our consolidated financial statements, although we are unable to predict the scope, timing, significance or outcome of the SEC inquiry referenced in that note, the inquiry may cause a diversion of our management’s time and attention and could have a material adverse effect on our reputation, business, results of operations, financial condition or cash flows.
−Removed: We incur substantial costs when identifying, evaluating, negotiating and closing acquisitions, and failure to integrate acquired businesses may adversely impact our business and financial results.
−Removed: We have completed a series of significant acquisitions and, continue to evaluate other potential acquisitions and strategic transactions, certain of which may also be significant.
−Removed: We have incurred, and will likely continue to incur, significant expenses in connection with evaluating, negotiating and consummating various acquisition and other strategic transactions.
−Removed: As we grow through acquisitions, we face the additional challenges of integrating the operations, culture, information management systems and other characteristics of the acquired entity with our own, including sales models related to capital equipment.
−Removed: Our efforts to integrate acquisitions may be hampered by delays, the loss of certain employees, suppliers or customers, proceedings resulting from employment terminations, culture clashes, unbudgeted costs, and other issues, which may occur at levels that are more severe or prolonged than anticipated.
−Removed: For example, in May and June 2023 we completed the acquisitions of substantially all the assets of Bluegrass and a portfolio of dialysis catheter products and the BioSentry Biopsy Tract Sealant System from AngioDynamics.
−Removed: Our integrations of the acquired assets are in their early stages and substantial risks and uncertainties exist with respect to our ability to achieve the operating and financial results, product and market development and other benefits we have projected with respect to the acquisitions.
−Removed: Among other challenges, these acquisitions will require us to transfer the manufacturing operations conducted with respect to the acquired assets, develop new manufacturing capabilities, enhance and expand our sales and marketing capabilities and extend the capacities of our regulatory, and research and development groups.
−Removed: There is no certainty that we will be able to effectively integrate, manufacture, market or commercialize the acquired assets.
−Removed: We could also face other challenges associated with completed or prospective acquisitions, which we may not currently anticipate.
−Removed: Additionally, past and future acquisitions may increase the risks of competition we face by, among other things, extending our operations into industry segments and product lines where we have few existing customers or qualified sales personnel and limited expertise.
−Removed: Further, as a result of certain acquisitions, we are selling capital equipment, in addition to our historical sales of disposable medical devices.
−Removed: The sale of capital equipment may create additional risks and potential liability, which may negatively affect our business, operations or financial condition.
−Removed: In addition, we may not realize competitive advantages, synergies or other benefits anticipated in connection with any such acquisition or other transaction.
−Removed: If we do not adequately identify and value targets for, or manage issues related to, acquisitions and strategic transactions, such transactions may not produce the anticipated benefits and have an adverse effect on our business, operations or financial condition.
−Removed: We have incurred expenses in connection with the disposition of
−Removed: businesses and assets which we acquired but determined that they did not produce the benefits contemplated at the time of acquisition.
−Removed: We may incur similar expenses in the future.
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.