Details are yet to come about Evolus Inc.'s "user-centric" focus regarding Jeuveau (prabotulinumtoxinA-xvfs) for injection, as the product goes up against Botox (onabotulinumtoxinA, Allergan plc) as well as Dysport (abobotulinumtoxinA, Galderma Laboratories LP) in treating severe glabellar (frown) lines associated with corrugator and/or procerus muscle activity in adults. There's also Xeomin (botulinum toxin type A, Merz Pharma GmbH & Co. KGaA).

Evolus CEO David Moatazedi said during a conference call that "as we get closer to commercialization [in the spring], we will provide more color around how we plan to execute the details." In any case, he said, the firm is confident that Jeuveau can become number two in frown-line therapy by volume at the end of 24 months, based on the "rapid uptake that we've observed with other products in the space. If you use other launched products as an analogue, generally the first 12 to 18 months is where they achieve the majority of their market share."

Jeuveau's name is meant to echo "nouveau," meaning "modern, up to date," and to fit nicely with the company's moniker, intended to signify an urge that consumers as well as the marketplace "evolve with us."

The clinical program with Jeuveau called Transparency involved the study of more than 2,100 patients globally, which included two U.S. pivotal phase III trials and a European and Canadian phase III head-to-head study vs. Botox in which all the primary and secondary endpoints were met with no serious drug-related adverse events reported. Jeuveau, which the company said would be priced well below market leader Botox, won approval after the company resubmitted the BLA to address deficiencies cited by the FDA in chemistry, manufacturing and controls.

Jeuveau is meant to be given three times over the course of a year. But the compound, unlike other therapies, bears no duration data in the label, which Moatazedi said was deliberate. Duration wasn't measured in experiments, which placed emphasis on responder rate, because the FDA's view of duration has changed over time. "We did not want a comparison of apples to oranges as a result of that shifting of the definition," he said. "We believe the doctor will make the decision to bring Jeuveau into practice based on the comprehensive Transparency data." Patients were followed out to five months, he noted. Michael Jafar, chief marketing officer, said that the "clinician wants to talk about duration in a different way," and having a broad dataset allows the doctor to "look at whatever day, be it 120, 150, whatever you want. You can make whatever comparison you like."

Mizuho analyst Irina Koffler noted in a report that the approval "was a widely anticipated event for both Evolus and Allergan," calling Jeuveau "essentially interchangeable" with Botox, and predicting that "doctors will be extremely receptive to a new 'frictionless' and lower-cost Botox alternative." Evolus will initially attempt to capture more share from Dysport rather than Botox, in her view. Botox has also been given marketing clearance for an array of other indications such as migraine, lower limb spasticity, overactive bladder, urinary incontinence and upper limb spasticity.

Koffler modeled $19.2 million in U.S. sales this year, growing to $300.4 million in 2026, with contribution from the outside-the-U.S. market beginning in 2020, and most sales this year taking place in the fourth quarter. A discounted price to cosmetic Botox and "the strong growth trends in the aesthetic market" should help Evolus, she said. With pricing "some 20-25 percent below Botox, and we already estimate 24 percent discounts, so we are leaving our forecast intact for now," she added, pointing out that "there could be some elasticity around this range based on clinic volumes."

Jeuveau's regulatory path, unlike its potential adoption, has not been without friction. In May of last year, the FDA issued a complete response letter related to the BLA, citing deficiencies limited to chemistry, manufacturing and controls. Paperwork was resubmitted in early August.

Also in play is Newark, Calif.-based Revance Therapeutics Inc., which in December disclosed that its long-acting neuromodulator, daxibotulinumtoxinA for injection (RT-002) with stabilizing excipient peptide technology, delivered positive top-line results in alleviating moderate to severe glabellar lines in the Sakura 3 phase III open-label, long-term safety study. The company plans to submit a BLA in the first half of this year.

Shares of Newport Beach, Calif.-based Evolus (NASDAQ:EOLS) ended Monday at $20.50, up $2.16 or 11.8 percent.