EOLS 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-05-04

• The global economy has experienced heightened volatility and disruptions, including enacted and threatened tariffs. While inflation in the United States is moderating, job growth has been muted, and consumer confidence has generally been weakening.

• Recently enacted tariffs by the United States have adversely affected and potentially will continue to adversely affect overall consumer sentiment and discretionary spending. As a result, lower consumer sentiment and discretionary spending have negatively impacted aesthetic procedures and our sales …

• The United States trade policy has been characterized by rapid changes in both the scope and legal basis of tariffs, including the imposition, invalidation and replacement of tariff regimes. Tariff policy remains subject to change, including through shifts in legal authority, scope, and duration, an…

• On February 20, 2026, the U.S. Supreme Court invalidated tariffs imposed under the International Emergency Economic Powers Act (“IEEPA”), creating the possibility that previously collected tariffs may be refunded by the U.S. government. In response, the U.S. government implemented new tariffs to rep…

• Additionally, on April 2, 2026, the White House issued a proclamation addressing imports of patented pharmaceuticals. The proclamation authorizes tariffs on certain imports, including from countries such as South Korea, subject to product scope, country treatment and company-specific arrangements, i…

相对上期删除的文字 · 来源:10-Q · 2025-11-05

• The global economy, including the financial and credit markets, has experienced heightened volatility and disruptions, including fluctuations in interest rates, newly enacted and threatened tariffs, and weakening consumer confidence. Elevated levels of inflation and recently enacted tariffs by the U…

• In April 2025, we launched Evolysse™ Form and Evolysse™ Smooth in the United States.

• On May 5, 2025, we entered into an Amended and Restated Loan Agreement (the “A&R Loan Agreement”) with Pharmakon (as defined below), which amends and restates the Prior Pharmakon Loan Agreement. Under the A&R Loan Agreement, Pharmakon agreed to make a senior secured term loan to us in an aggregate p…

• In August 2025, we announced the submission of Premarket Approval Application (“PMA”) to the U.S. Food and Drug Administration (“FDA”) for Evolysse™ Sculpt. We anticipate that the FDA’s review will follow the standard PMA process, with approval expected in the second half of 2026.

• We performed a strategic cost structure optimization during the quarter ended September 30, 2025, and, in connection with the restructuring initiative, $1.4 million of restructuring related costs were incurred.

相对上期新增的文字 · 来源:10-Q · 2026-05-04

• We have incurred significant losses since our inception, and we may continue to incur losses, which could adversely affect the market price of our common stock and our ability to raise additional capital.

• We are a global performance beauty company with a history of significant losses. To date, we have invested substantially all of our efforts and financial resources in the clinical development, regulatory approval, and commercial launch of Jeuveau® and Evolysse®. We began generating revenue in May 20…

• market share in the medical aesthetic market and long-standing customer loyalty programs and sales contracts with large customers which creates established business and financial relationships with customers, aesthetic societies and universities.

• With respect to consumer demand, the treatment with our products is an elective procedure, the cost of which must be borne by the consumer, and we do not expect costs related to the treatment to be reimbursable through any third-party payor, such as Medicaid, Medicare or commercial insurance. The de…

• If Jeuveau®, Evolysse®, or any future product candidates fail to achieve the broad degree of aesthetic practitioner adoption necessary for commercial success or the requisite consumer demand, our operating results and financial condition will be adversely affected, which may delay, prevent or limit …

相对上期删除的文字 · 来源:10-Q · 2025-11-05

• We are a global performance beauty company with a history of significant losses. To date, we have invested substantially all of our efforts and financial resources in the clinical development, regulatory approval, and commercial launch of Jeuveau® and Evolysse™. We began generating revenue in May 20…

• a strong market position before we are able to enter the market, which may create additional barriers to successfully commercializing Jeuveau®, Evolysse™ and any future product candidates and attracting practitioner and consumer demand.

• In addition, in its clinical trials, Jeuveau® was clinically tested and compared to BOTOX, both of which contain a 900 kDa complex. We believe that aesthetic practitioners’ familiarity with the 900 kDa complex’s handling, preparation and dosing will more easily facilitate incorporation of Jeuveau® i…

• With respect to consumer demand, the treatment with our products is an elective procedure, the cost of which must be borne by the consumer, and we do not expect costs related to the treatment to be reimbursable through any third-party payor, such as Medicaid, Medicare or commercial insurance. The de…

• If Jeuveau®, Evolysse™, or any future product candidates fail to achieve the broad degree of aesthetic practitioner adoption necessary for commercial success or the requisite consumer demand, our operating results and financial condition will be adversely affected, which may delay, prevent or limit …