Evolus, Inc. has entered into a definitive agreement with Symatese to be the exclusive distributor in the United Kingdom (U.K.) and Europe of four unique dermal fillers in late-stage development with anticipated regulatory clearances in the second half of 2024 and commercialization under the brand name Estyme (pronounced “esteem”) fillers in 2025.
This marks the second agreement Evolus has made with Symatese this year. The first obtained exclusive distribution rights to the same product line in the US, where it will be commercialized under the brand name Evolysse in 2025.
“The addition of the Estyme facial fillers in the U.K. and Europe will complement the recent launch of Nuceiva, our flagship neurotoxin, which has been met with very strong interest and growing demand from customers,” says David Moatazedi, President and Chief Executive Officer of Evolus, in a news release. “We are increasingly optimistic about the near-term potential that the next-generation technology in the Evolysse and Estyme fillers lines will offer customers in the fast-growing facial HA market. We are confident that these innovative new products, along with our growing brand loyalty to our market-leading neurotoxin and the associated digital infrastructure and distribution platform will drive our topline growth for years to come.”
The two distribution agreements for the Evolysse /Estyme fillers portfolio will grant Evolus the ability to offer filler solutions to cover mid-face, nasolabial folds, and lip indications in Europe plus an eye product line in the U.S.
Regulatory approval has been received for the first nasolabial fold product in Europe and the remaining three products are anticipated to be approved in the back half of 2024. U.S. regulatory approval remains on track to begin in 2025. The company plans to commence commercialization of the approved product lines in 2025 with subsequent product launches in 2026 and 2027.
As part of the new agreement, Evolus will be licensing its neurotoxin, Nuceiva (botulinum toxin type A), to Symatese for distribution in France, marking the fifth European market that Evolus has now entered. In addition, Evolus will sub-license its distribution rights for the Estyme fillers line to a Symatese subsidiary for distribution in France.
“We are extremely excited to expand our partnership with Evolus beyond the U.S. to now include the U.K. and Europe,” adds Jean-Paul Gérardin, CEO of Symatese, a privately held French company specializing in Class I to III medical devices. “We firmly believe in the growth opportunity for our innovative filler lines in these markets and also in Evolus’ accelerating growth in the neurotoxin market. As such, we have agreed to receive payment for the license for the European markets in the form of Evolus’ common shares. We have complete confidence in the Evolus team, and we look forward to pursuing this exceptional growth opportunity together.”
The products within the licensing agreement are a next-generation filler technology and the first to be developed using cold crosslinking manufacturing, which will be presented at IMCAS in February 2024.
Transaction Terms and Updated Outlook
In exchange for the exclusive distribution rights in the United Kingdom and Europe, Evolus will issue 610,000 shares of the company’s common stock to Symatese. Two milestone payments will be made: (1) €1.2 million on the second anniversary of certain regulatory approvals currently expected to be achieved in 2026, and (2) €1.9 million on the earlier of the third anniversary of certain regulatory approvals or following a year in which Evolus achieves €25 million in revenue in Europe, currently expected to be achieved by 2027, both of which will be after the commercialization of the applicable products. This agreement has no material impact on the company’s continued expectation to be fully funded to profitability by 2025.
Evolus will also pay Symatese a mid-single-digit royalty based on net sales and a transfer price for the product. Symatese will be responsible for the development of the products, including clinical studies, product testing, and the conduct of regulatory activities required to obtain and maintain all necessary regulatory approvals. The initial agreement is for a term of 15 years, with automatic five-year renewal provisions.
By leveraging the existing Evolus digital infrastructure, sales force, rewards program, and co-branded media, the company expects the Evolysse line to achieve a high contribution margin at scale, which is expected to drive an expansion of our consolidated operating margin and income.
Additionally, Evolus will pre-announce preliminary, unaudited fourth quarter and full-year 2023 results and revenue guidance for 2024 in January.
