COVID-19 Impacts
Meridian’s number one focus has been on protecting the health and welfare of the Meridian family, followed closely behind by meeting our commitments as a critical supplier to the health care industry. To date, Meridian has been successful in meeting both objectives.
Meridian has not experienced any material supply chain issues to date. Meridian maintains relationships with a number of critical suppliers operating in countries around the world including areas that are currently under or could be under “shelter in place” or similar orders. Just as Meridian serves as a critical supplier to the health care industry, many of our suppliers also are deemed to be critical businesses, which are generally exempt from governmental orders to temporarily cease operations; however, in some cases our suppliers may still not be able to operate or have reduced capacity due to staff that are unable to report to work for a variety of reasons. In general, Meridian maintains a multi-month inventory of raw materials and other components, and our suppliers continue to meet our demand. Where there has been some disruption or delay in supply, we have qualified backup suppliers and are continuously monitoring our supply chains.
Many of our clinical trial partners have suspended operations, which will likely result in delays for our products in the pipeline. This includes new assays for the revogene® and Curian® platforms, as well as our new PediaStat® system and its initial lead assay. While those new assays were not expected to receive FDA approval and contribute to revenue in fiscal 2020, their ultimate approval and contribution will be delayed, the extent to which remains unknown. For fiscal 2020, we expect this to reduce our R&D spending below our previously communicated amounts.
Meridian’s outlook on future periods and the aforementioned impacts reflect facts, circumstances and the Company’s assumptions as of today. The impacts ofCOVID-19 are evolving daily and the extent to whichCOVID-19 impacts Meridian’s business, operations, and financial results, including the duration and magnitude of such impacts, will depend on numerous risks , uncertainties and other factors the Company may not be able to accurately predict, including those discussed in the Risk Factors set forth in Meridian’s Annual Report on Form10-K and other reports filed with the U.S. Securities and Exchange Commission.
FORWARD-LOOKING STATEMENTS
The Private Securities Litigation Reform Act of 1995 provides a safe harbor from civil litigation for forward-looking statements accompanied by meaningful cautionary statements. Except for historical information, this report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, which may be identified by words such as “continues”, “estimates”, “anticipates”, “projects”, “plans”, “seeks”, “may”, “will”, “expects”, “intends”, “believes”, “signals”, “should”, “can” and similar expressions or the negative versions thereof and which also may be identified by their context. All statements that address operating performance or events or developments that Meridian expects or anticipates will occur in the future, including, but not limited to, statements relating to per share diluted earnings, sales, product demand, revenue and the impact ofCOVID-19 on our business and prospects, are forward-looking statements. Such statements, whether expressed or implied, are based upon current expectations of the Company and speak only as of the date made. Specifically, Meridian’s forward-looking statements are, and will be, based on management’s then-current views and assumptions regarding future events and operating performance. Meridian assumes no obligation to publicly update or revise any forward-looking statements even if experience or future changes make it clear that any projected results expressed or implied therein will not be realized. These statements are subject to various risks, uncertainties and other factors that could cause actual results to differ materially, including, without limitation, those described below.