Item 1A. Risk Factors
Item 1A. Risk Factors
The COVID-19 pandemic has disrupted how we, our suppliers and our customers operate and the duration and extent to which this will impact our business, future results of operations, liquidity and overall financial performance remains uncertain.
In late 2019, a novel coronavirus (“COVID-19”) was first reported in Wuhan, China, and on March 11, 2020, the World Health Organization characterized COVID-19 as a global pandemic. The outbreak has spread globally and has led governments and other authorities around the world, including federal, state and local authorities in the United States and elsewhere, to impose measures intended to control its spread, including restrictions on freedom of movement and business operations such as travel restrictions, border closings, business closures, quarantines and shelter-in-place orders. Additionally, the COVID-19 pandemic and the measures taken to limit its spread have negatively impacted the economy across many industries. As such, COVID-19 pandemic may pose significant risks to our business. We operate globally and the COVID-19 pandemic and its adverse effects have impacted most of the locations where we, our customers and our suppliers conduct business and as a result, during the second and third quarter of 2020, we have experienced some disruption to our operations, most notably due to reduced demand for our disposable product portfolio.
As a result of the COVID-19 pandemic, our non-essential offices and facilities, including our corporate headquarters remain closed to non-essential employees. With a large number of employees now working remotely there is a potential loss of productivity, which could negatively impact our future results.
Our manufacturing, distribution, and pump service facilities are operating under our business continuity plan due to the need for our critical healthcare products, however, we have taken certain precautionary measures including the following to maximize the safety of our employees and to mitigate disruption to our operations:
• implemented physical distancing measures;
• enhanced hygiene protocols and increased frequency of cleaning procedures;
• acquired additional personal protective equipment;
• developed contingency plans and protocols to assess employee illness;
• helped employees with childcare issues due to school and daycare closures;
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• implemented COVID-19 temperature screening for employees and visitors entering our manufacturing and distribution facilities; and
• initiated a visitor pre-entry questionnaire to limit potential exposure in our facilities.
While we anticipate that the foregoing measures are temporary, we cannot predict the specific duration for which these precautionary measures will stay in effect, and we may elect to take additional measures as the information available to us continues to develop. These actions, and any future actions we may take in response to the COVID-19 pandemic, could negatively impact our business, financial condition and results of operations.
During the first nine months of 2020, our operations have been impacted globally by lower admission rates and procedural volumes at our hospital customers. We have also incurred increased expenses as a result of COVID-19 for additional compensation paid to our manufacturing and distribution facility workers along with personal protection equipment and other items. At the same time, we have seen some expense decreases due to reductions in travel and other discretionary spending. The total impact of the COVID-19 pandemic on our business will not be fully reflected in our results of operations and overall financial performance until future periods. The duration and extent of the impact on our business from the COVID-19 pandemic depends on future developments that cannot be fully predicted at this time, as such, the impact of the COVID-19 pandemic on our future results of operations and overall financial performance remain uncertain and cannot as yet be quantified. A continued decline in the global economy could delay or significantly decrease purchases of our products in the future. Adverse economic and market conditions could also harm the parties with whom we do business, including our customers, distributors and suppliers. Additional factors that have contributed or may contribute to the adverse impact of the COVID-19 pandemic, on our business, results of operations, financial condition and liquidity include, without limitation, the following:
• lost revenue or additional costs associated with either disruptions at our production and distribution facilities or interruptions in our supply chain;
• fluctuations in demand from customers as a result of an increase in COVID-19 patient admissions in hospitals offset by the decline in non-COVID-19 patient admissions;
• healthcare customers that defer the more profitable elective procedures may experience financial difficulties and may be unable to pay within payment terms for the products they purchased;
• potential lower demand in future periods due to over-purchasing of our products due to the COVID-19 pandemic;
• reduced revenue due to delays in implementation of our infusion systems and oncology products at hospital locations due to restricted access;
• higher operating costs related to additional compensation paid to our manufacturing and distribution facility workers;
• volatility in revenue and income due to foreign currency fluctuations;
• lower travel and entertainment costs due to global travel restrictions;
• lower income due to a delay in cost savings projects as a result of the travel and social distancing requirements of COVID-19; and
• lower interest income on cash balances due to recent reductions in interest rates along with higher interest expense from borrowing under our Credit Facility if necessary to maintain adequate liquidity.
To the extent the COVID-19 pandemic and related containment measures continue to adversely affect regional, national and global economic conditions and financial markets, as well as the business, results of operations, financial conditions and liquidity of us, our suppliers and our customers, it may also have the effect of heightening many of the risks described in this ‘‘Risk Factors’’ section and elsewhere in this Quarterly Report on Form 10-Q for the quarter ended September 30, 2020 and many of the risks described under the caption ‘‘Risk Factors’’ and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2019, including the risks resulting from our dependency on key personnel; impairment of our supply chain or manufacturing facilities; and the impact of negative economic conditions. In addition, in light of the COVID-19 pandemic and the measures taken to limit its spread, our historical information regarding our business, results of operations, financial condition or liquidity may not be representative of the future results of operations, financial condition, liquidity or other financial or operating results of us or our business.
Our ability to manufacture products may be materially adversely impacted by COVID-19.
We manufacture out of four main facilities, Austin, Texas, Salt Lake City, Utah, Costa Rica and Mexico. If the manufacturing capabilities of any of these sites are impacted as a result of COVID-19, we may not be able to timely manufacture our products at the required levels or at all. A disruption at any of our manufacturing facilities could have a material, adverse effect on our business, results of operations, financial condition and cash flows. For example, the COVID-19 pandemic could have a substantial impact on our employees’ attendance and productivity due to a variety of factors, such as
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shelter-in-place orders, quarantines and short and long term illness, all of which could interrupt and delay the manufacture of our products.
Our suppliers may experience financial difficulties or business disruptions that could negatively affect their operations and their ability to supply us with the raw materials and components required for our products. Any delay or shortages of raw materials or components from our suppliers could interrupt and delay the manufacturing of our products.
Our sales may be materially adversely impacted by COVID-19.
Our non-essential offices and facilities remain closed to our non-essential employees, including our corporate headquarters, and a large number of employees continue to work remotely. In addition to this potentially hindering productivity, our sales force typically operates by meeting in person with customers to discuss our products. As many hospitals are currently restricting access to their facilities to essential personnel, this may negatively affect demand for our products by limiting the ability of our sales personnel to negotiate new and maintain existing contracts with customers. We may also experience significant reductions in demand for certain products as our health care customers re-prioritize the treatment of patients, delay elective procedures and shift resources and operations to fight COVID-19 and the complications it causes. For example, during the second and third quarters of 2020, we have experienced lower demand from hospital customers for our products other than our infusion pump hardware due to COVID-19. Additionally, the COVID-19 pandemic will potentially adversely affect our distributors as they may not be able to maintain the current levels of sales. As such, the impacts of COVID-19 on our sales force and our distributors could have a material adverse effect on our business, results of operations, financial condition and cash flows.
The COVID-19 pandemic has resulted in significant financial market and foreign currency volatility, which could adversely affect our earnings and cash flows.
The COVID-19 pandemic has led to periods of significant volatility in financial markets and foreign currency exchange rates. Given that our financial results are reported in U.S. dollars, but our operations are conducted internationally, currency exchange rate changes can have a significant impact on our financial results. During the nine months ended September 30, 2020, we recognized $6.0 million in net foreign exchange losses in our results of operations.
We are subject to risks associated with debt financing.
The credit agreement governing our Credit Facility contains, among other things, certain customary restrictive covenants that limit our ability to incur additional indebtedness and liens, merge with other companies or consummate certain changes of control, acquire other companies, make certain investments, pay dividends, enter into certain transactions with affiliates, and transfer or dispose of assets as well as financial covenants requiring us to maintain a specified consolidated total leverage ratio and a specified consolidated fixed charge coverage ratio. While we have not previously breached and are not currently in breach of these or any other covenants contained in our credit agreement, there can be no guarantee that we will not breach these covenants in the future.
Additionally, our ability to comply with these covenants may be affected by events beyond our control, including the COVID-19 pandemic. A breach of any of these covenants could result in a default under the credit agreement, which could cause all of the outstanding indebtedness under our Credit Facility to become immediately due and payable. These covenants could also limit our ability to seek capital through the incurrence of new indebtedness or, if we are unable to meet our obligations, require us to repay any outstanding amounts with sources of capital we may otherwise use to fund our business. As such, these restrictive covenants contained in our Credit Facility may restrict our ability to pursue our business strategies.
In evaluating an investment in our common stock, investors should consider carefully, among other things, the risk factors previously disclosed in Part I, Item 1A of our Annual Report on Form 10-K filed with the SEC for the year ended December 31, 2019, including the risks resulting from our foreign currency exchange rates, as well as the information contained in this Quarterly Report and our other reports and registration statements filed with the SEC.
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.