EvolusIn Inc. announced it 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 second half of 2024 and commercialization under the brand name Estyme(R) (pronounced "esteem") fillers in 2025. It is the second agreement made with Symatese this year -- with the first obtaining exclusive distribution rights to the same product line in the U.S., where it will be commercialized under the brand name Evolysse(TM) in 2025. As a result of the geographic expansion of the filler line, the company has doubled its total addressable international market (outside the U.S.) to $1.8 billion.

Neurotoxins and dermal fillers are the two most requested medical aesthetic procedures in the U.S. and Europe. The two distribution agreements for the Evolysse(TM). The two distribution agreements for theEvolysse(TM) /Estyme(R) fillers portfolio will grant Evolus the ability to offer a complete range of 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(R) (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(R) filler to Symatese for distribution in France, marks the fifth European market that EvOLus has now entered. In Additionally, Evolus will sub the distribution rights for the EstyMe(R) fillers line to a Symatese subsidiary for distribution in France. "We are extremely excited to expand partnership with Evolus beyond the U.S. to now include the U.K. and Europe.

Symatese has a unique and combined expertise in the field of hyaluronic acid and injection systems and is well known for the development of the latest generation of Restylane(R) products in the U.S. based on XpresHAn Technology(TM)/OBT(R). The products within the licensing agreement are a next-generation filler technology -- the first to be developed using cold crosslinking manufacturing -- which will be presented at IMCAS, 1st) -3rd) 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: EUR1.2 million on the second anniversary of certain regulatory approvals currently expected to be achieved in 2026, and EUR1.9 million on the earlier of the third anniversary of certain regulatory approvals or following a year in which Evolus achieves EUR25 million in revenue in Europe, currently expected to be achieved by 2027, both of which will be after the commercialization of the applicable products. Evolus is expanding its product portfolio having entered into a definitive agreement with symatese.