NEWPORT BEACH, Calif. - Evolus, Inc. (NASDAQ: NASDAQ:EOLS), a performance beauty company, announced its Evolysse™ dermal fillers showed positive results in a pivotal clinical trial against competitor Restylane-L. The study's findings were presented at the SCALE Meeting in Nashville on May 17, 2024.
The trial, which evaluated the efficacy of Evolysse™ Lift and Evolysse™ Smooth in treating nasolabial folds, met its primary endpoint of non-inferiority and demonstrated superiority to Restylane-L at six months. Secondary endpoints indicated significant improvement in fold severity at all measured timepoints over a 12-month period for Evolysse™ Lift, and at six and nine months for Evolysse™ Smooth.
The multicenter trial used a split face design, treating 140 patients with either Evolysse™ product on one side of the face and Restylane-L on the other, allowing for direct comparison. The primary endpoint was assessed using a validated 5-point scale by a blinded independent review panel.
No treatment-related serious adverse events were reported, and the safety profiles of the Evolysse™ fillers were similar to Restylane-L. These results support Evolus's plan to submit Premarket Approval applications for both products to the FDA within the next 90 days.
David Moatazedi, President and CEO of Evolus, expressed confidence in the upcoming submission, citing the trial's consistency with previous European data. Dr. Rui Avelar, Chief Medical Officer and Head of R&D, echoed this sentiment, emphasizing the trial's reinforcement of the company's R&D capabilities.
Dr. Steven Dayan, an investigator in the trial, noted the precision and effectiveness of the Evolysse™ HA filler line, which utilizes a novel Cold Technology process aimed at preserving the natural HA molecule structure.
Evolus's expansion into the dermal filler market complements its flagship neurotoxin product, Jeuveau®, and is anticipated to increase its total addressable market by 78%.
This announcement is based on a press release statement. The company's forward-looking statements involve risks and uncertainties, including the timing of regulatory submissions and approvals. Evolus has provided no specific financial details or commercial launch dates for the new products.
InvestingPro Insights
As Evolus, Inc. (NASDAQ: EOLS) gears up for its FDA submissions, recent market data from InvestingPro offers a glimpse into the company's financial health and stock performance. With a market capitalization of $850.88 million, Evolus is navigating the performance beauty space with a keen eye on expansion and innovation. Notably, the company has seen a significant return over the last week, with a 7.77% increase, and an even more impressive 17.87% return over the last month, reflecting positive investor sentiment following the clinical trial results of its Evolysse™ dermal fillers.
While the company has demonstrated strong revenue growth of 40.45% over the last twelve months as of Q1 2024, analysts are cautious, as they do not anticipate Evolus will be profitable this year. This is further underscored by a negative P/E ratio of -13.06, indicating that the company is currently not generating earnings to cover its share price. Nonetheless, Evolus operates with a moderate level of debt and has liquid assets that exceed its short-term obligations, suggesting a degree of financial stability as it moves forward with its product line expansion.
Investors interested in deeper analysis will find additional InvestingPro Tips for Evolus, including insights on the company's Price / Book multiple and its operating income margins. For those looking to make informed investment decisions, there are more tips available at InvestingPro. To enhance your InvestingPro experience, use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
It's worth noting that while Evolus does not pay a dividend to shareholders, the company's strategic moves in the performance beauty market, including the promising trial results of Evolysse™, could be a driving factor for future financial performance. With 9 additional InvestingPro Tips available, investors can gain a comprehensive understanding of Evolus's market position and potential growth trajectory.
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