−Removed: The Company has experienced challenges within the global supply chain which has impacted the business in three key areas:
−Removed: (i) movement and/or delay in production schedules due to component shortages, (ii) continued delays to global shipping and receipt of goods and (iii) increased shipping costs which has reduced gross profit margin.
−Removed: In addition, there is presently a global silicon chip supply shortage that could potentially cause disruptions in our supply chain.
−Removed: While the Company’s business has not yet been materially affected by such disruption, in the event any of the Company’s suppliers experience such supply chain disruption, there is potential that such disruption could ultimately affect our ability to timely obtain and deliver finished goods and products.
−Removed: Furthermore, there is heightened uncertainty surrounding global supply chains, global markets and general global economic uncertainty as a result of the ongoing conflict between Russia and the Ukraine and the continuing COVID-19 pandemic.
−Removed: As a result of our operations outside of the U.S., the Company is exposed to exchange rate risk that our operations and profitability may be affected by changes in the exchange rates between currencies.
−Removed: There are three types of risk caused by currency volatility:
−Removed: transaction exposure, translation exposure, and economic or operating exposure.
−Removed: Transaction exposure arises from the effect that exchange rate fluctuations have on a company’s obligations to make or receive payments in a foreign currency, translation exposure arises from the effects of currency fluctuations on a company’s consolidated financial statements and economic exposure is the effect of unexpected currency fluctuations on a company’s future cash flows and market value.
−Removed: In general, our reported financial results are affected positively by a weaker U.S.
−Removed: Dollar and are affected negatively by a stronger U.S.
−Removed: Dollar as compared to the foreign currencies in which we conduct our business.
−Removed: For additional risk factors pertinent to the Company’s business please refer to the Part I Item 1A of the Company’s 2021 Annual Report on Form 10-K, which was filed with the SEC on April 13, 2022 and is incorporated by reference herein.
+Added: For information regarding risk factors pertinent to the Company’s business please refer to Part I Item 1A of the Company’s 2022 Annual Report on Form 10-K, which was filed with the SEC on March 17, 2023 and is incorporated by reference herein.
+Added: There have been no material changes from the risk factors described in our Form 10-K other than the following:
+Added: Unstable market and economic conditions and potential disruptions in the credit markets may adversely affect our business, including the availability and cost of short-term funds for liquidity requirements and our ability to meet long-term commitments, which could adversely affect our results of operations, cash flows and financial condition.
+Added: If internally generated funds are not available from operations, we may be required to rely on the banking and credit markets to meet our financial commitments and short-term liquidity needs.
+Added: Our access to funds under our revolving credit facility or pursuant to arrangements with other financial institutions is dependent on the financial institution’s ability to meet funding commitments.
+Added: Financial institutions may not be able to meet their funding commitments if they experience shortages of capital and liquidity or if they experience high volumes of borrowing requests from other borrowers within a short period of time.
+Added: In addition, the global credit and financial markets have recently experienced extreme volatility and disruptions, including severely diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth, inflationary pressure and interest rate changes and uncertainty about economic stability.
+Added: More recently, the closures of Silicon Valley Bank, Signature Bank and First Republic Bank and their placement into receivership with the Federal Deposit Insurance Corporation (FDIC) created bank-specific and broader financial institution liquidity risk and concerns.
+Added: Although the Department of the Treasury, the Federal Reserve and the FDIC jointly released a statement that depositors at Silicon Valley Bank and Signature Bank would have access to their funds, even those in excess of the standard FDIC insurance limits, under a systemic risk exception, future adverse developments with respect to specific financial institutions or the broader financial services industry may lead to market-wide liquidity shortages, impair the ability of companies to access near-term working capital needs, and create additional market and economic uncertainty.
+Added: There can be no assurance that future credit and financial market instability and a deterioration in confidence in economic conditions will not occur.
+Added: Our general business strategy may be adversely affected by any such economic downturn, liquidity shortages, volatile business environment or continued unpredictable and unstable market conditions.
+Added: If the equity and credit markets deteriorate, or if adverse developments are experienced by financial institutions, it may cause short-term liquidity risk and also make any necessary debt or equity financing more difficult, more costly and more dilutive.
+Added: Failure to secure any necessary financing in a timely manner and on favorable terms could have a material adverse effect on our growth strategy, financial performance and stock price and could require us to delay or abandon clinical development plans.
+Added: In addition, there is a risk that one or more of our current service providers, financial institutions, manufacturers and other partners may be adversely affected by the foregoing risks, which could directly affect our ability to attain our operating goals on schedule and on budget.
Unregistered Sales of Equity Securities and Use of Proceeds.
DEFAULTS UPON SENIOR SECURITIES
+Added: Not Applicable
MINE SAFETY DISCLOSURES
1 unchanged sentence
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.