In addition to the other information set forth in this Quarterly Report on Form 10-Q, you should carefully consider the factors discussed in “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025 filed with the SEC on March 4, 2026, which could materially affect our business, financial condition or future results.
−Removed: Except as set forth below, there have been no material changes in our risk factors from those disclosed in that Annual Report.
−Removed: A reduction or elimination of coverage or reimbursement of our products by third-party payors, including Medicare, in the future could adversely affect our business and results of operations.
−Removed: A substantial portion of our revenues are derived from reimbursement by Medicare and other third-party payors for our ventilator products and services.
−Removed: Currently, ventilators are covered under the National Coverage Determination ("NCD") for the DME Reference List, effective since April 1, 2003, for the treatment of neuromuscular diseases, thoracic restrictive diseases, and chronic respiratory failure resulting from chronic obstructive pulmonary disease ("COPD").
−Removed: While the DME Reference List has been updated, no standalone NCD has been issued for ventilators.
−Removed: On June 9, 2025, CMS finalized a new NCD establishing clear medical necessity criteria for noninvasive positive pressure ventilation ("NIPPV") in the home for treatment of chronic respiratory failure related to COPD.
−Removed: We actively participated in the national coverage analysis process, including submission of formal comments and ongoing engagement with CMS, the Department of Health and Human Services, and members of Congress.
−Removed: The final NCD may significantly affect patient access, reimbursement, and utilization of ventilator therapies.
−Removed: Because Medicare coverage policies often influence commercial payors, including Medicare Advantage plans, changes to Medicare policy may have broader implications across our payer base.
−Removed: Any reduction or elimination of coverage or reimbursement by Medicare or other third-party payors, or an inability to maintain or expand coverage with additional commercial payors, could materially and adversely impact our business, financial condition, and results of operations.
−Removed: Adverse global macroeconomic conditions, including supply chain disruptions, tariffs, and fluctuations in foreign currency exchange rates, could negatively impact our operations, costs, and profitability.
−Removed: Our business may be affected by a range of global macroeconomic conditions, including newly imposed tariffs, disruptions to the supply chain, and fluctuations in foreign currency exchange rates.
−Removed: While nearly all of our revenues are generated within the United States and denominated in U.S.
−Removed: dollars, we rely on both domestic and international suppliers for the medical equipment and supplies we rent and sell to patients.
−Removed: As a result, our cost structure and operational efficiency are subject to global market dynamics that may influence the availability and pricing of key products.
−Removed: We are primarily exposed to trade policy and tariff developments indirectly, through supplier pricing and component sourcing rather than direct import activity.
−Removed: In early 2025, the U.S.
−Removed: government announced new tariffs on a broad range of imported goods from multiple countries, prompting reciprocal tariffs from affected trade partners.
−Removed: While medical equipment has traditionally been excluded from such tariffs, the expanded scope of recent trade measures and the possibility of further escalation create significant uncertainty around equipment pricing and supply availability.
−Removed: To date, we have not experienced a significant impact on our operating costs or supply availability as a result of these tariff actions, but the timing, scope, and duration of future measures remain unpredictable.
−Removed: The Company is actively monitoring these developments and continuously assessing their potential operational and financial impacts.
−Removed: Additionally, global supply chain constraints continue to pose risks to our ability to acquire essential equipment and components in a timely and efficient manner.
−Removed: Factors such as raw material shortages, longer lead times from suppliers, and increased transportation expenses may limit our responsiveness to patient needs and may affect our ability to scale the business effectively.
−Removed: Although our operations are primarily domestic, we are indirectly exposed to foreign currency exchange rate fluctuations through our international sourcing activities.
−Removed: Changes in the value of the U.S.
−Removed: dollar relative to other currencies, including the Canadian
−Removed: dollar and Chinese yuan, may impact the prices we pay to suppliers, which could increase our cost of goods sold and reduce our gross margins.
−Removed: If these macroeconomic pressures persist or worsen, our ability to manage supply continuity, control costs, and meet patient demand could be adversely affected.
−Removed: As a result, our financial condition, operating results, and long-term strategic objectives may be negatively impacted.
+Added: There have been no material changes in our risk factors from those disclosed in that Annual Report.
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.