Evolus Stock Price, News & Analysis

Evolus (NASDAQ: EOLS) has submitted the final module of its premarket approval (PMA) application to the FDA for its Evolysse™ Lift and Evolysse™ Smooth dermal filler products, aimed at treating nasolabial folds (NLF). The submission is a significant milestone for the company, expecting FDA approval in the second half of 2025. The PMA includes data from a U.S. pivotal study involving 140 patients, comparing Evolysse™ fillers to Restylane-L. Both products met their primary endpoint of non-inferiority and showed superiority to Restylane-L at six months. Evolus aims to position Evolysse™ Lift as versatile for facial wrinkles and folds, while Evolysse™ Smooth offers a softer alternative.

Evolus has launched its botulinum toxin type A product, Nuceiva, in Spain, one of Europe's largest markets for aesthetic injectables. This move is part of Evolus's geographic expansion strategy.

Nuceiva is approved for the temporary improvement of moderate to severe glabellar lines in adults under 65. The launch signifies Evolus's commitment to growth by establishing a direct presence in key regions. Led by Maria Cudeiro, Evolus aims to work closely with Spanish healthcare professionals to offer effective treatments.

Nuceiva has shown promising results in three Phase III trials and two long-term safety studies, with side effects similar to other neurotoxins. The product is known as Jeuveau in the US and has been the fastest-growing neurotoxin there for three consecutive years.

Evolus, a performance beauty company, announced the grant of stock options and restricted stock units (RSUs) to 9 newly hired non-executive employees. The grants consist of options to purchase 30,778 shares and 29,546 RSUs under the 2023 Inducement Incentive Plan.

The stock options, with an exercise price of $11.69, have a 10-year term and vest over 4 years, while the RSUs vest 25% annually over four years. These measures were taken as inducement for new employees, in line with Nasdaq Listing Rule 5635(c)(4).

Evolus has announced positive topline results from a U.S. pivotal study for its dermal fillers, Evolysse™ Lift and Smooth. Presented at the 2024 SCALE Meeting, the study showed that both products met primary and secondary endpoints, demonstrating superiority over Restylane-L in improving nasolabial fold severity at multiple time points. The safety profiles of the products were similar to Restylane-L with no serious adverse events. Evolus plans to submit Premarket Approval applications to the FDA within the next 90 days, potentially expanding their market by 78%, complementing their neurotoxin Jeuveau®.

Evolus celebrates the fifth anniversary of its flagship product, Jeuveau®, at the Women's Wear Daily (WWD) Beauty CEO Summit, where CEO David Moatazedi speaks.

Jeuveau® has been the fastest-growing aesthetic neurotoxin in the U.S. over the last three years, emphasizing the company's market impact. Evolus aims to redefine beauty through its performance beauty approach, focusing on younger demographics. The summit highlights Evolus' role in driving growth and innovation in global beauty.

Moatazedi reflects on Evolus' progress, evolving from a single-product company to a multi-product innovator in the beauty aesthetics space.

Evolus, Inc. reported granting stock options and restricted stock units to 14 new non-executive employees under the 2023 Inducement Incentive Plan. The awards have a vesting commencement date of May 7, 2024, with stock options priced at $13.42 per share and a 10-year term. RSUs vest annually over 4 years. The grants are compliant with Nasdaq Listing Rule 5635(c)(4).

Evolus, Inc. announced that Sandra Beaver, the Chief Financial Officer, has been honored as the Public Company CFO of the Year by the Orange County Business Journal. Since joining in 2022, she has significantly contributed to the company's growth and success. Sandra supported the licensing agreements expanding the product portfolio by adding late-stage dermal fillers in the U.S. and European markets, increasing the addressable market by 78% to $6 billion. She also led the geographic expansion to Austria, Germany, and Italy, guiding the company to financial success and strategic decision-making.

Evolus, Inc. (NASDAQ: EOLS) reported Q1 2024 net revenue of $59.3 million, a 42% increase from Q1 2023. They aim for non-GAAP profitability in Q4 2024 and full year 2025. The company completed U.S. clinical trials for Evolysse® Lift and Smooth fillers, with FDA submission expected soon. Evolus reaffirmed full-year 2024 net revenue guidance of $255 million to $265 million, on track to achieve total net revenue goal of $700 million by 2028.