Revance CEO Mark Foley joins Yahoo Finance Live to discuss the therapeutic company's anti-wrinkle Daxxify treatment, its multi-use purposes, and its competition with traditional Botox injections.
SEANA SMITH: A big development in the health care space. The FDA approving a new treatment from Revance Therapeutics. And analysts saying that it is a big threat to Botox shares. Revance rallying today. You can see it up just about 21%.
Well, joining us now is Mark Foley. He's the CEO of Revance Therapeutics, along with Yahoo Finance's reporter Anjalee Khemlani. Mark, it's great to see you. Obviously, congratulations on the approval for your treatment.
A number of analysts weighing in. One of them, being from Cowen, called out with a note saying that this is, quote, "the first real competitive threat here to Botox." So, in your words, how does it stack up?
MARK FOLEY: Well, for us, I'd put it in three terms. Number one is the duration profile. So in our trials, we've seen six-month median duration with some patients, seeing results out to nine months.
The second is the actual differentiated way that we formulate the product. And so, we use a peptide instead of human serum albumin or animal proteins, which is what most of the competitors use. So we've been able to accomplish this based on the differentiated formulation that we have.
And the last thing is the unmet need. So in all of our market research, the duration of toxins, 88% of consumers would like to see a longer-acting acting toxin, and 86% of injectors. So we're coming into a large established market with a very differentiated product that we think is going to meet the desires of the consumers and the injectors.
ANJALEE KHEMLANI: Mark, Anjalee here. On that point of the toxins, you still have the same warning on the label as all the other products that are out there. Walk us through, you know, what the risks are there, and how that differentiates between other Botox and toxin products.
MARK FOLEY: So what we've seen in the clinical trials, and they've been extensively studied, is that the safety profile of our product is very consistent with other neuromodulators that are on the market. And for a large part, they're very safe, and most of the side effects are transient in nature.
So in our trials, for example, we saw 6% headaches. We saw 2% of ptosis, which is a droopiness. And 1% of a facial paresis, which is very much in line with conventional neurotoxins.
And as you're probably aware, these are done millions of times a year, so the safety profile is great. And where we're seeing the real differentiation is on the duration side, in terms of the median duration of six months. And again, some patients seeing results out to nine months.
ANJALEE KHEMLANI: We also know that Botox, in particular, has been used for other indications as well. Do you see room for a trial for that as well and expanding the use?
MARK FOLEY: Absolutely. So while toxins are probably more known in the aesthetic category, it's a little-known fact that, actually they are more broadly used-- or the market size is bigger outside of aesthetics-- in therapeutic indications. So migraines, cervical dystonia, upper limb spasticity, overactive bladder. And so, there's a huge opportunity in the therapeutic category.
We've already completed a clinical program in cervical dystonia and will be submitting what's called a Supplemental BLA for that indication shortly, and would expect a PDUFA action date for that indication in 2023. So we absolutely do plan to enter the therapeutic market. We believe that the duration profile that we've demonstrated in our clinical trials is going to be of great interest to those patients that are suffering with some of these debilitating conditions.
SEANA SMITH: Mark, you mentioned earlier that this is a large established market. There's a lot of big Botox believers out there. How do you overcome that loyalty and draw in those patients?
MARK FOLEY: Well, as you mentioned-- so large market-- the US neurotoxin market for aesthetics is about a $1.7 billion market that continues to see impressive growth. High single digits, low double digits on a year-over-year basis. So when you're coming into an established large category, the best way to compete is with differentiation.
This product that we're bringing into the market will be the first true innovation in formulation in over 30 years in this category. And so, we plan to go after the unmet need, where both consumers and injectors have indicated a desire to have a product that lasts longer. And so, we're already in the market in the US with a line of hyaluronic acid fillers.
We have found that the strategy that we're using in the market is resonating and working. We've generated over $130 million of revenue since launch with this line of fillers. And so, now that we have this very differentiated neurotoxin coming into the market, we'll partner with the fillers. We'll sell it through the same US sales force to the same customer. So we're really excited about the portfolio that we've assembled, and, obviously, this will be the cornerstone for that platform.
ANJALEE KHEMLANI: Jumping off of Seana's question as well, looking at also the cost. How do you plan on differentiating yourself in the market there?
MARK FOLEY: Yes. So we're an interesting business. First off, it's cash pay and not reimbursed, so it's a bit of a free market in terms of whatever injectors feel consumers will pay. That's what they charge. And we're a B2B2C business, so we'll sell to the accounts. The injectors or the physicians will then turn around and determine what price to target the consumers.
We do expect this to carry a premium to existing neurotoxins out there. But there's a lot of factors that ultimately influence the price to the practice and then, ultimately, the practice to the patient. So it'll depend a little bit on what practices feel is the appropriate price for consumers. But we would expect it to be at a slight premium to the conventional neurotoxin market.
ANJALEE KHEMLANI: Broadly speaking, we know that aesthetics really took off during the pandemic. Are you hoping that that continues moving forward and to, sort of, capture the market from there?
MARK FOLEY: We do. Again, if you look at the trends-- certainly in the pandemic environment where Zoom became the de facto way of communicating, people were looking at themselves all day on camera and realized that, hey, there are some wrinkles or volume loss that I would like to treat. And so, that has certainly helped activate the market even more so.
But if you go back pre-pandemic, the market was already growing in the high single digits. And so, we think there are some global trends that are going to continue. Younger people engaging in aesthetic treatments. People wanting to retain the best version of themselves and pursuing non-invasive treatments over invasive treatments.
And we're still-- what we would consider under-penetrated in the US market when you look at some of the markets outside of the United States. So we continue to be very bullish in terms of what we think the growth trends are going to be going forward.
SEANA SMITH: Mark Foley, CEO of Revance Therapeutics, thanks so much for joining us. And our thanks to Anjalee Khemlani as well.