Revance Therapeutics Inc (RVNC) 2021 Q2 法說會逐字稿

Good day, everyone. Welcome to Revance Therapeutics Second Quarter 2021 Financial Results and Corporate Update Conference Call. (Operator Instructions) As a reminder, this call is being recorded today, August 5, 2021.

I would now like to turn the conference over to Jessica Serra, Head of Investor Relations and ESG for Revance. Please go ahead.

Joining us on the call today from Revance is President and Chief Executive Officer, Mark Foley; Chief Financial Officer, Tobin Schilke; Chief Operating Officer and President of R&D and Product Operations,Dr. Abhay Joshi; Chief Commercial Officer, Aesthetics and Therapeutics, Dustin Sjuts; and President of Innovation and Technology, Aubrey Rankin.

During this conference call, management will make forward-looking statements including statements related to the clinical development of our product candidates, our business strategy, planned operations, commercialization plans, potential benefits of our drug product candidates and technology, the launch of the next-generation fintech platform, the timing of any potential approval of DaxibotulinumtoxinA for injection, 2021 guidance, expected cash runway and and financial performance. These forward-looking statements are based on the company's current expectations and inherently involve significant risks and uncertainties.

Our actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties.

Also on today's call, we will present both GAAP and non-GAAP financial measures. A reconciliation of non-GAAP to GAAP measures included in our earnings release.

With that, I will turn the call over to Mark Foley. Mark?

Thank you, Jessica. Good afternoon, everyone, and thank you for joining our second quarter 2021 financial results conference call. We're very pleased to report strong second quarter results highlighted by $17 million in RHA revenue over 2,000 aesthetic accounts shared across products and services, and over $500 million in fintech processing volume run rate. Our focus on execution, supported by healthy aesthetics market led to our third consecutive quarter of revenue growth since becoming a commercial entity and further validated our commercial launch strategy. These results would not have been possible without the entire Revance organization working together as a team. I continue to be impressed by the exceptional talent we've been able to attract to the company and by their unwavering commitment and dedication to deliver on our objectives.

With the FDA having initiated their pre-approval inspection of our manufacturing facility in June, we continue to anticipate the approval of our lead product, DaxibotulinumtoxinA for injection for the treatment of glabellar lines this year. In the meantime, the Revance team is actively building inventory and solidifying our commercial launch plans for innovative neuromodulators. We look forward to introducing the first true innovation in the neuromodulator category in over 30 years. And once approved, DaxibotulinumtoxinA for injection will not only anchor our aesthetics portfolio and also lay the foundation for our therapeutics franchise. We expect the second half of the year to be very busy and exciting, particularly we anticipate several catalysts in our therapeutic pipeline, which I'll cover later in this call.

With that, let me turn the call over to Dustin, who will cover the performance of our aesthetics business in the second quarter. Dustin?

Thank you, Mark. We have built a solid track record of execution since our initial commercial launch with over 2,000 accounts across 40 states, now carrying arctic collection and/or using our payment platform. This is up from 1,500 accounts in the first quarter. Our consistent results continue to reinforce our confidence in our proceeds go-to-market strategy. During the second quarter, through a combination of our sales efforts and injector education, RHA sales increased to $17 million, up from $11.6 million in the prior quarter. Growth was also complemented by a seasonally busy period for aesthetic procedures.

As we've noted before, Q2 and Q4 are generally more active quarters for aesthetic procedures compared to Q1 and Q3. Given these patterns, we expect our revenue growth to be moderated in Q3, particularly as our sales team ramped up their training to prepare for the potential commercial launch of DaxibotulinumtoxinA for injection once approved. We then expect to return to a seasonally stronger fourth quarter.

Turning to our aesthetic fintech platform. We're pleased to see continued growth in the platform's processing volume run rate, up to over $400 million in Q1 to over $500 million at the end of Q2. We were also on target and completing the launch of PayFac , becoming an authorized payment facilitator entail extensive testing, controls and regulations. With a big undertaking the entire organization, as a significant accomplishment, we are now well positioned to unlock substantial value in our service offering for practices.

As a reminder, PayFac enabled us to participate in more of a credit card processing value chain. Further, as a PayFac, we'll be able to leverage the source data to build new features and functionalities that enhance the overall value proposition of our services offering. We are now in the market, beta-testing our next-generation Fintech platform, which we expect to commercially launch in the fourth quarter. We are finalizing roll out plan and look forward to sharing more details on the new platform soon.

Given the technical and commercial preparations underway, we will be moderating new account activations with the launch of the new platform. Until then, we'll include both the legacy and the new platform when accounting for our service revenue and payment processing volume run rate.

Before I turn the call to Mark, I'd like to introduce a few recent key hires across Revance aesthetics and Revance therapeutics in support of our commercial evolution. First, as part of our commitment to developing our fintech services segment, I'm pleased to share the appointment of Käthe Anchel as the General Manager of Financial Services in our fintech platform. He brings over 20 years of experience in designing and building successful consumer products in payments, e-commerce and financial services at leading organizations, including Umpqua Bank, Citigroup and PayPal. Käthe will be instrumental in setting our long-term aesthetic services strategy while also ensuring a smooth launch of our next-generation fintech platform. We're excited to have her on board and look forward to leveraging her leadership and experience, as we continue to evolve and grow the aesthetics franchise.

As to therapeutics, we're now at a critical inflection point. We are pivoting our focus to commercial launch preparations, following strong data from a very successful Phase III pivotal trial for DaxibotulinumtoxinA for injection in the treatment of cervical dystonia, following closely behind of our clinical for adult limb spasticity, which is preparing for Phase II. For these reasons, we're pleased to announce the appointment of Rob Bancroft as the General Manager of Therapeutics. Rob adds the strength of our team, bringing more than 25 years of experience in healthcare and life sciences industries. He also has a strong background in the therapeutic toxin space. At Allergan, Rob is instrumental in leading global pipeline development strategies for both our therapeutics, laying the groundwork for expansion investments like spasticity, migraine, neurogenic/ overactive bladder. Most recently, Rob was the CEO for QMENTA, a company focused on accelerating solutions for brain diseases. Prior to that, he was Executive Vice President of Healthpoint Biotherapeutics. With a strong background and track record, Rob will help strengthen our therapeutics pipeline strategy and advance our clinical development, all of our franchise through commercialization. The strong team and infrastructure in place, we look forward to elevating the value of our therapeutics franchise and entering the growing $2.3 billion global therapeutic modulate market.

With that, I'll turn the call back over to Mark to discuss our upcoming pipeline on outlets. Mark?

Thanks, Dustin. We are anticipating key milestones in our therapeutics pipeline in the second half of the year. As Dustin mentioned, we are currently in Phase III clinical trials evaluating DaxibotulinumtoxinA for injection for the treatment of cervical dystonia. In the second half, we expect to share the results from our ASPEN open-label long-term safety study. Afterwards, we plan on filing the supplemental biologics license application in 2022 with anticipated approval in 2023.

Our clinical team is also preparing for a Phase III program in adult upper limb spasticity. You'll recall that we completed our JUNIPER Phase II study in February of this year, and our plan remains to hold an end of Phase II (technical difficulty) Commercial activities for the DaxibotulinumtoxinA for injection. SG&A expenses include depreciation and amortization and stock-based compensation. Excluding these expenses, non-GAAP SG&A expenses were $42.4 million.

Research and development expenses were $29.4 million for the second quarter, reflecting costs related to clinical trials, regulatory support for ongoing biologics license application, pre-commercial manufacturing and our fintech platform development.

R&D expenses include depreciation and amortization and stock-based compensation. Excluding these expenses, non-GAAP R&D expenses were $24.9 million. We continue to balance growth with financial discipline during the quarter, and our balance sheet remains strong heading into the second half of the year.

Cash, cash equivalents and short-term investments as of June 30, 2021, were $336.3 million, which we believe is sufficient to fund our operating plan into 2024. Further, we reaffirmed our previously announced 2021 guidance. (technical difficulty) Approximately 71.8 million with 76.7 million fully diluted shares, excluding the impact of convertible debt.

And with that, I'll turn the call back over to Mark.

Thank you, Tobin. In closing, we're very proud of our performance in the first half of the year and anticipate a strong finish in the second half with the potential approval of DaxibotulinumtoxinA for injection and further advancement in our therapeutics pipeline. We also remain in a solid financial position with division cash to support our growth initiatives into 2024.

With that, I will now open the call up for questions. Operator?

(Operator Instructions) We will have our first question from the line of Seamus Fernandez from Guggenheim.

So I'll do my one question and follow-up. But just to kick off with the first question. Your AbbVie really -- under the Allergan moniker, really delivered a very, very strong second quarter. Congrats on your guys' second quarter. One thing that they commented on was that they anticipated that approximately 2/3 of the demand was regular way demand and then about 1/3 was pent up. Would you guys maybe just comment on your thoughts around that statement? And what it means relative to sort of the growth of the market relative to share taking as you think about it? And then I'll just -- I have one other follow-up question.

Seamus, this is Mark. I don't know that we've got any sort of better data than that. We're in launch phase. So obviously, the accounts that we're dealing with represents sort of a smaller fraction of the overall market. Having said that, I would say that our focus on prestige and the high-end nature of these accounts, there's definitely a pretty healthy backlog. And so we're talking with them. There's no doubt there's some pent-up demand. There's clearly some new consumers that are entering the market somewhat in the Zoom effect and everything else. We feel very good that we've returned at least for now back to levels that were pre-pandemic. And certainly, we would expect that we'll continue to see overall market growth. But I don't know that we have anything additional to add. We feel very good about where we are in the market, where we are with accounts, as you can tell with the roughly 2,000 or so accounts that we're in between our products and services that were being pretty targeted. But clearly, we're seeing a nice healthy market right now.

Great. And then just as the second question very quickly on just obviously, you're expressing a high degree of confidence in the launch. And so I'm assuming that the FDA inspection is going swimmingly. Maybe you could just give us a general sense of how you would encourage us to think about the launch and uptake, obviously, given your premium strategy in the fourth quarter versus how we should think about the rollout through the balance and maybe just without guiding specifically, but just kind of the rollout through the balance of 2022.

Yes. Thanks for asking that. First, on the FDA process and where we're at, consistent with prior commentary, we indicated that prior to our PDUFA date, everything had been addressed except for the on-site inspection as part of our PAI, where we press released that an inspection date had not been scheduled yet. And then due to the FDA delays, we were in a bit of a holding pattern waiting for that to occur. Given that this is our first drug approval, remote inspection without possibility and they're going to need to physically inspect the plant. We then in the spring, put out a press release that we've been given an inspection date to occur before the end of Q2. And obviously, in our press release and in our remarks, the FDA has shown up at our facility. So we continue to feel very good that they're following sort of through with the expected inspection plan.

I think you're sensing consistency with our tone around the expected approval before year-end. We've taken advantage of this time to keep up sort of our readiness for the inspection and continue to advance our commercial preparation plans.

In terms of the launch trajectory, we've also tried to be consistent. This will be the first time that our product has been used outside of clinical trials. And as a result, we're going to be sort of very thoughtful and intentional in the first phase of our launch, similar to what we did with the RHA filler line. And so I think for the balance of this year likely and post approval, we're going to spend most of our time focusing on ensuring that we're going to get really good, reproducible outcomes that are consistent with our clinical trial data. And that commercial launch is likely to be much more of a 2022 phenomenon.

So that's how we're thinking about it, but there will be this stub period post approval, where we are going to need to spend some time with a select group of customers, getting real low commercial experience before going through a more traditional launch.

And now our next question comes from the line of Terence Flynn from Goldman Sachs.

Maybe just one follow-up, Mark, on the DAXI manufacturing side. In the past, I think you've noted about a 6- to 10-week time line for a turnaround from the agency. Just wondering if that's still your expectation. And then obviously, a strong quarter for the filler side here. So -- and obviously, breadth contributed, but just wondering what you're seeing from the reorder side of things.

Yes. So first off, we intentionally didn't give sort of a set time frame because we're outside of the PDUFA clock, where within the PDUFA framework, everything is moving towards the deadline. It's hard to know exactly the time frame that the agency is going to work under as it relates to the inspection. Clearly, they're trying their best, I think, to resolve any of these outstanding issues. And so we continue to pick our commentary that we're focused on an approval certainly before the end of 2021, and have full preparation and build schedule going on in the interim.

Regarding this filler and reorder rates, I think it's still a little early for us to make a lot of commentary around it. This is our third full quarter of launch that we still are seeing a cycle of accounts coming online, figuring out where it fits in their practice. And then we also expect with the approval of our neuromodulator that's going to introduce another new dynamic in there that may change a little bit sort of the percent of the business and accounts willing to consider giving to us, which accounts might be willing to lean in that we're otherwise waiting until we had a pull back. So I think it's still a little bit early as certainly as we get visibility and have data that we think is more reflective of what the business is going to look like going forward. We're happy to share, but we still think we're a little bit early in that process.

Your next question comes from the line of Annabel Samimy from Stifel.

Just a little bit more on the commercial preparations you're doing ahead of the approval. What are you able to do? You've obviously penetrated a decent amount of accounts. Is there anything that you can do outside of potential training and education such as commercial work, contracting work, preliminary contracting, preliminary negotiation? Is there any of that stuff that can happen ahead of time that could potentially smooth the process for the launch and not pull away too much of the energy from the filler momentum that you're having?

And then on the manufacturing side, I realize that you said that this is a process. And so I imagine that means that there's a bit of a back and forth, if there are any issues that do come up, would you be telegraphing any of that? Or is this just -- you're keeping it as part of the process and you're still on board for second half, and that's about what you're going to say.

So first on the commercial prep, obviously, in the absence of approval, there's not much that we can do from a promotional standpoint or anything until we have approval. So when we talk about commercial prep, it's all around -- we continue to refine our pricing strategy and more market research work that we've been doing. I think that we've taken advantage of this gap between the launch of the filler and the expected approval of neuromodulator to build further relationships with physicians at the customer level. So we're continuing to establish the prestige Revance for aesthetics brand. I think people see us now as a company that's working towards a broader range of products, both from a services and a product stage.

And then obviously, we talked about building inventory in advance of launch. So one of the launch preps is internal activities, getting all our sales materials ready and everything to support that. So that's kind of more of what we're doing on the commercial prep side. On the manufacturing side, we kind of broke protocol in commenting on where we were in our FDA journey, given the pandemic when we talked about the fact that inspection had not been scheduled prior to the PDUFA. And then again, putting out a press release that one had been scheduled for the end of June. So I wouldn't read into my commentary about process. This is sort of a standard piece that needs to happen before approval. So the next communication you'll hear from us is kind of once we get the decision. But again, come back to the fact that we feel very good about our prep and where we were in that process and we continue all of our preparations in the hopeful approval of the product.

Our next question comes from the line of David Amsellem from Piper Sandler.

So first question is on the fillers. I don't know if you talked about this in your prepared remarks and sorry if I missed it, but can you just talk about the mix among the different SKUs? Are there any that have predominating? Or are there any that have gained particular traction or that practices have a real affinity for, thus far? I know it's still relatively early in the commercial life, and these are early days. But as things evolve, what are you seeing out there in the field? So that's the number one.

And then number two, can you just remind us on DAXI once you get approval, what sort of net are you going to cast in terms of training of injectors. In other words, how many should we expect you to have trained within the first 6 and, say, 12 months of the commercial life of DAXI. And over time, should we expect some sales force expansion, given that there are more injectors of neuromodulators than there are of filers. So how should we think about that?

Great. Thanks, David. So the first one on the mix side of it, we didn't address those in our scripted comments that previously what we said last quarter was that it was roughly 1/3, 1/3, 1/3. We're not seeing a major shift between Q3 and 4. We're still early, I think people are still figuring out. And I've been surprised when we've been out on the field, kind of the range of places that people are using it. Obviously, we're limited to focusing on indications on glabellar lines. But I think that we're finding folks use this or different performance characteristics. And you'll hear from 1 already that they like the performance characteristics for RHA 2, somebody else on RHA 4. So right now, it's still pretty even. I'm sure we'll see some separation over time. But right now, it continues to be presumably split, the 1/3, 1/3, 1/3.

In terms of our neuromodulator and how we're thinking about the launch in 6 to 12 months post launch, we remain committed to kind of the prestige and targeted strategy and what we've talked about before is that out of the 30,000 to 40,000 injector accounts that we think there are in the U.S., a top 1/3 of those are really the targets that we're going after and that we would expect over time to be in roughly half of that top 1/3. So right now, we're in 2,000 accounts. Those are obviously going to be sort of our bias accounts to go after first because they leaned in with RHA because of the prestige strategy. They like the idea of no pricing. And so that's the same group of customers that we expect are going to appreciate the differentiated value of our neuromodulator. And so we're still a little early to talk about exactly kind of the number of accounts that we expect to target over time. I think that starts getting a little bit more towards guidance. But Phase I is going to be make sure that as the product is used commercially that we're building from a position of strength in terms of the outcomes. And then after that, we'll sort of more broadly introduce it certainly to the prestige accounts that have already expressed an interest with us. And then there's no doubt that there will be a broader number of accounts that I think are going to have an interest in leaning in with us once the neuromodulator is approved.

Your next question comes from the line of Tim Lugo from William Blair.

And I know most of you all on the phone have probably heard this question over the past few years, but ahead of, hopefully, an approval and launch of DAXI, I just wanted to revolve the thoughts around physicians and how they want to see their patients more often, not less often. I don't agree with that view. But could you just refresh us with kind of what you're hearing from physicians, who have used DAXI in the clinical trials and maybe some of the interest you're hearing from the field from RHA marketing? Just really an update on that thought of a long-duration asset versus the short-acting neurotoxin and the excitement around this?

Yes. So Tim, as it relates to sort of the long duration profile that we've seen in the clinical trials with our neuromodulator and sort of how that might fit into clinical practice and the impact at couple of data points that we'll bring up. There's a lot of market data out there that despite conventional neuromodulators lasting kind of 3 months, 4 months, that average consumers only come in sort of 1.9x a year or less. So first and foremost, we think it figures in very well to what the normal pattern is of consumers. Secondly, particularly with the prestige accounts that we're going after, when we've been out on the field, these folks if anything have long waiting lists. And so getting into these accounts is the challenge. And so if you're a provider, the only way that you can necessarily increase sort of the services that you offer to your patients were increased profitability so you can do more services at the same setting. And a neuromodulator treatment every twice a year fits really well with also providing filler as well. So this idea that you can add sort of both filler and neurotoxins together to give better outcomes to patients and increase the per-visit ticket makes a kind of sense.

So in the customers that we're talking to, and obviously, we've got a bias towards those that are leaning into the prestige strategy, it resonates a lot. The last thing I would say is, innovation for us underpins everything, but what that does also create choice -- creates more choice at the physician level and at the consumer level. And so with a longer-acting neuromodulator, we're not trying to be everything to everybody. And so there are consumers in a practice that prefer coming in 3, 4 times a year, and that's the case that they want to practice more often. That's great. But based on our market research, we think there's a not insignificant number of consumers that really will put a premium on a neuromodulator that lasts longer. And so we think practice is being able to provide choice, figuring out what this makes a lot of sense. So we continue to feel really good about the value proposition and how this is going to fit into practices both from a consumer demand and from a profitability standpoint.

That's great to hear. And maybe my one follow-up. In the therapeutic category, I just don't understand why a long-duration product would not be -- would not capture a majority of share eventually in an indication like cervical dystonia, could -- I know you're obviously adding to the therapeutic side of your franchise with the addition of Rob. But can you maybe talk to some of the market research and remind us about the market research in the therapeutic side?

Sure, Tim. I would say that's sort of -- what our market research shows as well. It actually shows that in the therapeutic area that we could become a share leader. I think it speaks to the fact that these are debilitating diseases and that the ability to reduce the frequency of visits obviously gives a prolonged symptom relief, but it also takes some stress off of the system, right? It's less facility fee, physician time and everything else. And so if you look at the data that we generated from our CD program, not only was the duration profile, a really strong but we had a very encouraging safety signal as well with low dysphagia rates. And so we really are optimistic about the neuromodulator performance in clinical trials and therapeutics. And so that's why we announced some of the new hires that we have starting to get ready for commercial introduction of our cervical dystonia indications and feel very good about the performance profile of the product in the therapeutic market.

Our next question comes from the line of Balaji Prasad from Barclays. Again, our next question comes from the line of Balaji Prasad.

Apologies if this has been asked before, but just want to go back to the number of accounts opened this quarter -- net accounts opened 2,000 and try to extrapolate this as to what's likely to be the account opening run rate by the end of the year? And how this could tie up to your eventual DAXI launch?

Yes. So thanks a lot. We've reported sort of the total number of combined accounts between our services platform and our products, which is our RHA product line at the end of each quarter. So we talked about there being over 500 at the end of Q3, over 1,000 at the end of Q4, over 1,500 at the end of Q1. And now over 2,000 at the end of Q2. So we've been averaging 500 or so new accounts as per quarter. Obviously, with some of the new products and programs that we have coming out, we need to sort of look to say, the account activation is important and making sure that with some of these new services that we're going deeper in the existing accounts, but I think those are reasonable numbers for now. I think post approval of our neuromodulator, we'll need to revisit that because, again, our strategy is much more . We clearly have a lot of run room in these accounts that we view to be our target market opportunity. But certainly with this tracking right now, it's not unreasonable to sort of look at 500 new account adds per quarter, as something that could continue to exist for the balance of the year.

Mark, that's helpful. And maybe a quick one on bias in the BOTOX to just see where you are post your rate submission? Sorry, this is with regard to the FDA data package that submitted a couple of months ago.

On the biosimilar, what we indicated was that the next step in that program is to have a meeting with the agency to determine the Phase III program that would be required for approval. We expect that to happen before year-end. I know that the agency has their own conference call coming up soon, they might give a little bit more commentary on it, but we continue to be encouraged by the dialogue that we've had with them. And again, there will be a meeting with the agency to lay out sort of what that program is going to look like before year-end.

Our next question comes from the line of Serge Belanger from Needham & Company.

First one for Mark. Can you just give us a refresher of the open-label safety study in cervical dystonia, from which you'll be reporting results in the second half. If I recall, patients are eligible to receive multiple courses of treatment. So maybe just give us an idea of what you'll be looking for in terms of efficacy, duration and safety?

Yes. So on the open-label safety study, it was really a dose escalation study, looking at primary endpoint that was to look at the safety of sort of repeat doses over time. And so when we report that out, it's much more of a looking at the safety profile of the product and how patients respond to, again, these different doses that occur over time and an increase in doses if that's what the clinicians ultimately decide. So it's less about sort of the duration profile and more about the safety side of it. So that's what we'll be reporting out on that.

Okay. And secondly, with the addition of Rob Bancroft to the therapeutics team, should we look at that as kind of confirmation that you're moving forward with the commercialization effort for the muscle movement disorder in view of commercial partnership?

Yes, that's correct. In addition to Rob, we also announced last quarter the addition of another senior level person on the healthcare reimbursement side that -- so that we're focusing on that as well. And so we've long talked about our focus on building out sort of a direct sales force in the muscle movement space. And these are some of the key pieces that we're putting in place to allow us to access and enter that market. As it relates to cervical dystonia, we talked about filing in '22 and approval in '23. So it's not too far away. And we believe that there's a fair bit of opportunity to be unlocked there. And as we talked previously, we think that the performance profile of our product will allow us to be very competitive in the therapeutic category.

Our next question comes from the line of Ken Cacciatore from Cowen.

Congratulations, just really great performance without yet having DAXI. So as we think forward, I know, Mark, you want to be thoughtful in terms of how the product has rolled out the experience -- the initial experience, some of the kind of key users have. Can you talk a little bit about now that AbbVie has taken over control of the BOTOX franchise. Kind of anything that they're doing different that maybe you all could apply or as you step back and look at the overall marketplace in terms of timing for you all and DTC and really differentiating this product as we think through maybe the latter part of 2022, not necessarily the near term. Is there kind of any nuances you can give us as you approach this market that maybe has been different in the past that we're going to try to do a little bit different in the future?

Thanks, Ken. No, not really. I mean, obviously, as the market leader, they talk a lot about sort of increasing DTC dollars. They've got a big push into training new injectors. So they're going to expand sort of the number of folks that are actually doing toxin treatments. Our strategy is a little different, right? We're going after sort of the top of the pyramid on that side of it. But I think all of these things happening in concert, are no doubt going to help grow the overall market. So if we would expect that they're going to continue to run their playbook, which is more awareness dollars, more couponing to customers, training of new injectors, all of which will help grow the market. And as we come into the market with innovation, we will also drive more consumer awareness who are coming in, but ours is going to be much more focused again on these kind of prestige and high-end practices. So we don't expect a whole lot different in terms of the way that we view the market. Certainly, once we hit the market, I'm sure it's going to be quite competitive. But both of us will have kind of the playbooks that we'll run once we hit there. But from an overall approach to the market, I don't see any major differences from that standpoint.

(Operator Instructions) Our next question comes from the line of Vamil Divan from Mizuho.

So maybe just a couple for me. One on the PayFac integration that you talked about for next quarter. Can you maybe just provide a little more insight for the benefits do you think that's going to provide kind of that side of your business? And then the second part, would just be maybe any update you might have around your efforts around migraine and you've talked about that being a matter of sort of when you work on that as opposed to if you work on that, but just curious if there's anything new as that market obviously is evolving pretty rapidly as well. So any new thoughts would be helpful.

Great. Thanks, Vamil. So first on the PayFac side of it, the real advantage to PayFac in addition to participating in more of the overall margin stream of the credit card processing is -- the big advantage is it gives us access to the source level data. So right now, the HintMD system is a robust credit card processor, but it doesn't necessarily give us access to the source level data. So things around data analytics and insights and even automating subscription services in a way that's seamless and easy to set up and white label loyalty becomes a lot harder if you don't have access to the source data. So by becoming a payment facilitator, we then are able to scrape that source data, which, again, it will be the practices information, but then we can turn around and use that to help them with data insights and analytics. And so that's really the key functional -- functionality piece that's going to hand. So we're very encouraged with how the data launch of that is going and how it's performing. And again, that will be sort of the foundation that will build out these other services on top of. And again, it will allow us the ability to participate in a little bit more margin spread if we choose to hold on to that or if we choose to give them back to the practices.

On the migraine side of it, to your point, we talked about it, sort of not an if and when. And I think what we said most recently is that we would sort of consider this as part of our 2022 planning cycle. And so we'll be, I think, better prepared to address sort of where migraine fit in to our overall therapeutic strategy and what priorities that we have ultimately for 2022 when we give a little bit more color on our 2022 operating plan.

Our next question comes from the line of Douglas Tsao from H. C. Wainright.

Chris Bialas here on for Douglas Tsao. Congrats on the quarter. So I was just a little bit interested in the prestige segment that you're targeting for DAXI now. Our competitor yours is heavily targeting the millennial demographic. And I was just wondering how much overlap that is between these two segments.

Chris, this is Dustin. I think we need to separate the segmentation around consumer and in separation around practices. So the prestige strategy is around, our focus is really on partnering with those practices that drive value to the experience they provide to patients as well as an outcome they rise to patients. So those practices see all patient types. Those might be millennials and ways that all between. So our strategy is really different from the other than that we believe we can build the most amount of loyalty directly to those practices by providing that experience with us and great innovated products and then the consumers that they treat the loyalty practice. So our loyalty really lies in driving it to those factors. So those factors will see all the millennials that will be coming into the space, just as much as the others.

(Operator Instructions) We don't have any further questions. I would now like to hand the call back to Mark Foley.

Thank you, operator. Before I make my closing comments, I just wanted to recap some of our therapeutic milestones for the second half. My understanding is that the sound quality for that section was not great. So in the second half, we expect -- second half of this year, we expect to share the results of our ASPEN open-label long-term safety study. Afterwards, we plan on filing a supplemental biologics license application in 2022 with anticipated in 2023. And again, that's for our cervical dystonia program. And then our clinical team is also preparing for a Phase III program in adult upper limb spasticity. You'll recall that we completed our JUNIPER Phase II study in February of this year, and our plan remains to hold an end of Phase II meeting with the FDA before year-end.

So to close things out in the coming months, we plan to virtually attend the Citi and Wells Fargo healthcare conferences. We welcome your request for meetings. These events are directly through us. Feel free to reach out to Jessica if you'd like to schedule some time.

With that, I'd like to thank all of you for participating in today's call. Thanks.

Ladies and gentlemen, this concludes today's conference call. Thank you for participating.

Goodbye.

You may now disconnect.