NEWPORT BEACH, Calif. - Evolus, Inc. (NASDAQ: NASDAQ:EOLS), known for its aesthetic product portfolio, has recently achieved a significant regulatory milestone with the EU Medical Device Regulation (MDR) certification for its Estyme® line of injectable hyaluronic acid (HA) gels. This development, announced today, allows the company to enter the European dermal filler market, effectively doubling its addressable market outside the U.S. to an estimated $1.8 billion.
The MDR certification process, known for its rigorous safety and efficacy standards, has granted the CE Mark to the Estyme® brand, which is known as Evolysse™ in the U.S. Evolus plans to launch Estyme® in Europe through a limited experience program with select physician partners, aiming to refine its broader launch strategy based on the insights gathered. A full-scale European launch is anticipated for the second half of 2025.
David Moatazedi, President and CEO of Evolus, emphasized the importance of the certification, stating that it reflects the company's commitment to high-quality products that meet stringent regulatory standards. Dr. Rui Avelar, Chief Medical Officer and Head of R&D, highlighted the proprietary cold technology and breakthrough cross-linking technology used in Estyme®, which are expected to set the product apart in the marketplace.
Evolus has also confirmed that it is on track for U.S. approval and launch of the Evolysse™ injectable HA gels, targeting the beginning of 2025. The company's strategic expansion includes an exclusive agreement to distribute Evolysse™ in the U.S. and Estyme® in Europe.
The company's flagship product, Jeuveau® (prabotulinumtoxinA-xvfs), is the only neurotoxin dedicated exclusively to aesthetics and is manufactured using Hi-Pure™ technology. With the introduction of Estyme® and Evolysse™, Evolus continues to evolve its portfolio to meet the growing demand for premium aesthetic treatments.
This news is based on a press release statement from Evolus, Inc.
In other recent news, Evolus Inc . reported a profitable second quarter in 2024, with a 36% increase in revenue, amounting to $66.9 million. The medical aesthetics company revised its full-year 2024 revenue guidance upwards to between $260 million and $270 million. The firm H.C. Wainwright maintained a Buy rating for Evolus, citing the company's product Jeuveau's market gains and the anticipated launch of the Evolysse fillers. Meanwhile, Mizuho Securities also maintained an Outperform rating for Evolus, increasing its price target to $25.00 from $23.00. This adjustment followed Evolus' recent Analyst Day, which highlighted Evolus' strong branding, digital platform, and upcoming product launches, notably the fourth-quarter 2025 introduction of the Evolysse filler. Mizuho also revised its 2028 revenue estimate for Evolus upward to $706 million from the prior estimate of $661 million, following the introduction of Club Evolus, a unique subscription model. These are recent developments for Evolus.
InvestingPro Insights
Evolus Inc.'s recent regulatory success with the EU Medical Device Regulation certification for its Estyme® line aligns well with the company's strong financial performance and market positioning. According to InvestingPro data, Evolus has demonstrated impressive revenue growth, with a 40.71% increase in the last twelve months as of Q2 2024, reaching $237.26 million. This growth trajectory supports the company's expansion plans into the European dermal filler market.
The market has responded positively to Evolus's strategic moves, as evidenced by the company's stellar stock performance. InvestingPro Tips highlight that Evolus has seen a high return over the last year, with a remarkable 120.39% price total return. This surge in stock value suggests strong investor confidence in the company's growth prospects and product pipeline.
Despite these positive indicators, it's worth noting that Evolus is not currently profitable, with an operating income of -$30.16 million in the last twelve months. However, the company's gross profit margin stands at a healthy 69.72%, indicating efficient production processes and potential for future profitability as it scales its operations and enters new markets.
For investors seeking more comprehensive analysis, InvestingPro offers additional insights, with 8 more tips available for Evolus. These tips could provide valuable context for understanding the company's financial health and market position as it embarks on this significant European expansion.
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