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New words:
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abbreviation, affixed, Albany, Amendment, appeal, Appellate, Appendix, Armstrong, asterisk, Attorney, August, behalf, cancel, CE, century, Community, comparable, Complaint, Conformit, Consent, court, defense, denied, description, designated, Discontinuance, discontinued, dismissal, dismissed, Division, duly, Earl, electricity, employed, enforceable, evaluate, exceeded, Exhibit, forgo, formatted, French, fringe, furnished, Grid, herewith, honored, iii, implementation, inapplicable, incorporation, Indemnification, Index, interactive, invoice, issue, iv, John, leasing, leave, lessee, LLP, March, Mohawk, motion, moved, multiplied, NCG, Niagara, notified, Notwithstanding, obligated, operated, oral, power, premature, prepayment, ratably, reflecting, Refsland, reply, restated, restraining, reversed, RubinBrown, ruled, ruling, running, Schedule, sending, shorter, signature, sought, Stipulation, stopped, Supreme, thereunto, Trademark, trial, uncollectibility, undergo, undersigned, Weil, withdraw, XBRL
Financial report summary
?Risks
- We are subject to substantial domestic and international government regulation, including regulatory quality standards applicable to our manufacturing and quality processes. Failure by us to comply with these standards could have an adverse effect on our business, financial condition or results of operations.
- Our products may be subject to product recalls even after receiving FDA clearance or approval, which would harm our reputation and our business.
- Our success depends upon the development of new products and product enhancements, which entails considerable time and expense.
- We are dependent on adequate protection of our patent and proprietary rights.
- Decreased availability or increased costs of raw materials could increase our costs of producing our products.
- We are exposed to certain credit risks, resulting primarily from customer sales.
- Our common stock is thinly traded and its market price may fluctuate widely.
- If a natural or man-made disaster strikes our manufacturing facilities, we may be unable to manufacture certain products for a substantial amount of time and our revenue could decline.
- If we are unable to hire or retain key employees, it could have a negative impact on our business.
- We have a history of net losses in fiscal 2019, 2020 and 2022 and we may not be able to return to profitability in the future and there is substantial doubt about our ability to continue as a going concern.
- We participate in a highly competitive environment.
- Our business of manufacturing, marketing, and selling of medical devices involves the risk of liability claims and such claims could seriously harm our business, particularly if our insurance coverage is inadequate.
- Changes to the U.S. healthcare industry and third party payment structures may not be favorable to us.
Management Discussion
- Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations
- The Company believes that the Covid-19 pandemic resulted in increased sales in of ventilator products in fiscal 2021, however, this peak in demand ended in fiscal 2021 and the impacts of the COVID-19 continue to develop. In fiscal 2022 demand dropped from the peak, and the Company believes that COVID-19 is no longer contributing positively to product demand.
- The pandemic is partially responsible for broad economic changes which have impacted the Company in fiscal 2021, and fiscal 2022 and continue to impact the Company as the Company begins fiscal 2023. Inflation has raised the cost of products and services the Company uses to provide its products. In fiscal year 2021, the Company estimates that inflationary price increases raised product cost by approximately $500,000. In fiscal year 2022, the Company estimates that inflationary price increases raised product cost by an additional $1.3 million dollars. While the Federal Reserve initially believed some of the inflation in the economy was transitory in nature, the Company believes inflation will continue to increase cost in fiscal 2023.