Q2 2021 Revance Therapeutics Inc Earnings Call
[music].
Good day, everyone and welcome to revenge of Therapeutics second quarter, 2021 financial results and corporate update conference call. At this time, all participants are in a listen only mode.
Operator: everyone. Welcome to Wee-Vent Therapeutics Second Quarter 2021, Financial Assault, and Corporate Update Conference Call. At this time, all participants are in a listen-only mode. Following the management's prepared remarks, we will hold a Q&A session. To ensure that we will have ample time to address everyone's questions during Q&A, we would like to ask for a limit of one question and one follow-up question per person. To ask a question during that time, please press star, followed by one on your touchstone phone.
Following the managements prepared remarks, we will hold the Q&A session.
To ensure the we will have ample time to address everyones questions during Q&A.
I'd like to ask for a limit of 1 question and 1 follow up question per person.
To ask a question during that time. The please press star followed by 1 on your thoughts doing phone. If anyone has difficulty hearing of the conference call. Please press star zero for operator assistance.
Operator: If anyone has difficulty hearing the conference call, please press Star Zero for operator assistance. As a reminder, this call is being recorded today, August 5, 2021. I would now like to turn the conference over to Jessica Sarah, Head of Investor Relations and ESG for Rivens. Please go ahead, joining us on the call today, Ms. Rehan, and she is up.
The reminder, this call is being recorded today August 5 of 20 to anyone.
I would now like to turn the conference over to Jessica Sarah head of Investor Relations and ESG for me then.
Go ahead.
Yeah.
Jessica Serra: Announced joining us on the call today, Maria, of President and Chief Executive Officer Mark Foley, Chief Financial Officer Toby Shilke, Chief Operating Officer and President of R&D and Product Operations, Dr. Al-Bijot. She's Commercial Officer, Aesthetics, and President of Innovation and Technology Operations Thank you. First, Tom and call management only forward-looking statements, including statements related to the clinical development of our pocket candidates, our business strategy, plan operations, commercialization, forms, potential benefits of our drug product candidates, and technology, the launch of the next generation FITEC platform, the timing of any potential approval of that, Bajumontasas, Day, for injection.
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Unknown Executive: 2021 guidance, expected cash firm way.
Finally, 1 of items expected cash burn rate.
Unknown Executive: expected cash firm weight in the area These forward voting statements are based on the company's current expectations and, in health, involve risk and is not certain. Our actual results and the time you can differ materially from the anticipated such as the following statement.
These forward looking statements are based on the company.
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Actual results for the time.
Many of them.
Could differ materially from those.
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Unknown Executive: Also, in today's call, we will present both Gap and Non-Gap Financial Measures, a reconciliation of non-Gas messages.
As for adults.
On today's call.
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The financial metrics.
The foundation of non-GAAP GAAP.
GAAP much.
Unknown Executive: which is concluded about those For that, I would try to call over to Mark Pol. Thank you, Jessica.
Of that.
I will turn the call over to Mark Mark.
Thank you Jessica and good afternoon, everyone and thank you for joining our second quarter 2021, the financial results conference call for <unk>.
Very pleased to report strong second quarter results highlighted by $17 million and oriented revenue over 2000 of a set of accounts share across products and services.
Mark J. Foley: 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 rates. Our focus on execution, supported by a 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 Revenged organization working together as a team.
The over $500 million debt processing volume run rate of.
Focus on execution supported by healthy aesthetics market led to our third consecutive quarter of revenue growth since becoming the commercial entities and further validated for commercial launch strategy.
These results would not have been possible without the hiring if organization working together with the team.
I think the been impressed by the exceptional talent.
The name to attract of the company and by the unwavering commitment and dedication to deliver on our objectives.
With the FDA, having initiated their preapproval inspection of our manufacturing facility in June we continue to anticipate the approval of our lead product <unk>.
Bottom line and talk today for injection for free.
In terms of Cabela's lines this year.
The 3 of the team is actively building inventory.
On solidifying our commercial launch plans for innovative neuromodulators.
We look for to introducing the first true innovation in the neuromodulator category and over 30 years and once approved Dr. Botulinum toxin day for injection well not only for our aesthetics portfolio golf the lay the foundation for our therapeutics franchise.
Mark J. Foley: 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, Accomotuline and Toxidate for injection for the treatment of glabler lines this year. In the meantime, the remand team is actively building inventory and solidifying our commercial launch plans for this innovative neuromodulator.
We expect for the second half of the year to be very busy and exciting, particularly as we anticipate several catalysts in our therapeutics pipeline, which I'll cover later on 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.
Thank you Mark we are building the solid track record of execution since our initial commercial launch. So the 2000 accounts across 40 states now carrying the arbitration with.
And we're using our payments platform.
This is up from 1500 accounts from the first quarter.
Consistent results continue to reinforce our confidence and the proceeds go to market strategy.
Mark J. Foley: We look forward to introducing the first true innovation in their neuromodulator category in over 30 years, and once approved, Daxibotuline and ToxidAidAid for injection would not only anchor our aesthetics portfolio but also lay a foundation for our therapeutics franchise. We expect the second half of the year to be very busy and exciting, particularly as we anticipate several catalysts in our therapeutics pipeline, which I will discuss later in this call. With that, I will turn the call over to Dustin, who will discuss the performance of our aesthetics business in the second quarter. Thank you, Mark.
During the second quarter through a combination of our sales efforts and gesture of education or the case sales increased to $17 million up from 11.6 million in the prior quarter. Gross is also complemented by a seasonally busy period for a set of procedures.
As we noted before Q2 and 2 for are generally more active quarters for a set of procedures compared to Q1 and Q3.
Given these patterns, except for remainder of revenue growth to be moderate in the future, particularly as our sales team ramped up the training to prepare for the potential commercial launch of vastly botulinum toxin a for injection. Once approved we then expect to return to a seasonally stronger fourth quarter.
Turning to our set of Fintech platform. We're pleased to see continued growth on the platform processing volume run rate up from over $400 million in Q1 over $500 billion at the.
Dustin S. Sjuts: We have built a solid track record of execution since our initial commercial launch. With over 2,000 accounts across 40 states now carrying RHA collections or using our payment platform. This is up from 1,500 accounts in the first quarter. Our consistent results continue to reinforce our confidence and our prestige go-to-market strategy. During the second quarter, through a combination of our sales efforts and injector education, RHA sales increased $17 million, up from $11.6 million in the prior quarter. Growth was also complemented by a seasonally busy period for aesthetic receipts.
As of Q2.
We are also on target and completing the launch of the payback, becoming an authorized the payment facilitator until of extensive testing control and regulation.
Big undertakings of the entire organization is significant the cost.
We are now well positioned unlock substantial value in our service offering for the practices.
As a reminder, payback enabled us to participate in more on the credit card processing value chain further as the payback will be able to leverage the source data to build new features and functionality and enhance the overall value proposition of our services offering.
We are now in the market beta testing of our next generation Finfet platform, which the expected commercially launched from the fourth quarter gross.
Finalize the rollout plan and look forward to sharing more detail on the new platform share.
Given the technical and commercial preparations underway, we'll be moderating new accounts activation the launch of the new platform.
Until then we will include both the legacy and the new platform when accounting for our service revenue and payment processing the volume run rate.
Dustin S. Sjuts: As you've done before, Q2 and Q4 are generally more active quarters for aesthetic procedures compared to Q1 and Q3. Given these patterns, we expect our massive revenue growth to be moderated in the future, particularly as our stale team ramps up their training to prepare for the potential commercial launch of Daxi BOTS-A or injection once approved. We would then expect to return to a seasonally stronger fourth quarter.
Before I turn the call remark I'd like to introduce a few recent key hires across the vast set of.
And our vet therapeutics in support of our commercial evolution.
First as part of our commitment to developing our Fintech services segment I am pleased to share the appointment of chaos agile as the general manager of financial services and our Fintech platform.
And the brings over 20 years of experience in designing and building, except for consumer products and payments E Commerce, and financial services, and leading organizations, including the Quebec, Citigroup and Paypal Kols.
Dustin S. Sjuts: Turning to our Stetics FinTech platform, we're pleased to see continued growth in the platform's processing volume run rate, up from over $400 million in Q1 to over $500 billion at the end of Q2. We are also on target and completing the launch of Payfax, becoming an authorized payment facilitator and completing extensive testing, controls, and regulations. It was a big undertaking for the entire organization as significant accomplishments were made. We are now well positioned, and we have unlocked substantial value in our service law brains to practice. As a reminder, Payfack enabled us to participate in more of the credit card processing value chain.
He will be instrumental in setting our long term instead of services strategy, while also ensuring the smooth launch of our next generation Fintech platform where the.
So I didn't have the on board and look forward to leveraging of our leadership and experience as we continue to evolve and grow gift index franchise.
As for Therapeutics for now on a critical inflection point, we are pivoting our focus to the commercial launch preparations going strong data for our very successful phase III pivotal trial production of botulinum toxin H for injections in the treatment of cervical dystonia.
Following closely behind because of our clinical program for adult the specificity, which is preparing for phase III for.
For these reasons, we're pleased to announce the appointment of Rob Bancroft as the general manager of Therapeutics broadband for the strength of our team, bringing more than 25 years of experience in healthcare and life Sciences.
Dustin S. Sjuts: Further, as a PayFack partner, we'll be able to leverage the source data to build new features and functionality that enhance the overall value proposition of our services offering. We are now in the market, beta-setting our next generation FinTech platform, which we expect to commercially launch in the fourth quarter. You're finalizing a rollout 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 activation 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.
He also has a strong background in the therapy of talks of the space at Allergan, Rob was instrumental in the global pipeline development strategy for both of our therapeutics laying the groundwork for expansion of investments like specificity migraine neurogenic overactive bladder gross.
Recently from the CEO for collector of company focused on accelerating solutions for brands in the prior to that skews the executive Vice President of <unk> Biotherapeutics.
With the strong background and track record of Rob will help strengthen our therapeutics pipeline strategy and advance our clinical development on.
All of the guiding our franchise through commercialization.
The strong team of infrastructure in place, we look forward to elevate the value of our therapeutics franchise, the entering the growing to $3 billion global therapeutics for a modular market the bad.
I'll turn the call back over to Mark to discuss our upcoming pipeline.
Thanks, Tom.
We are anticipating using key.
Sales at our therapeutics pipeline in the second half of the year.
The mentioned we are currently in phase III clinical trials evaluating <unk> for you about your line of talk today for injection for the true.
Dustin S. Sjuts: Before I turn to call for Mark, I'd like to introduce a few recent key hires across revamped aesthetics and revamped 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 Akata Ansel as a general manager of Financial Services and our FinTech platform. Kata brings over 20 years of experience designing and building successful consumer products in payments, e-commerce, and financial services at leading organizations, including Kubek, Citibu, and PayPal.
<unk> of cervical dystonia.
In the second half, we expect to share the results from our Aspen Open label long term safety study.
Afterwards, the plan on filing the supplemental biologics license application in 2022 with anticipated approval in 2023.
Our clinical team is also preparing for phase III program in adult upper limb spasticity.
Recall that we completed our juniper phase II study in February of this year.
<unk> remains to hold at the end of phase II.
Commercial activities for the Dax botulinum toxin 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.
Dustin S. Sjuts: Kay will be instrumental in setting our long-term aesthetic services strategy and 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 for therapeutics, we're now at a critical inflection point. We're pivoting our focus to commercial launch preparations, following strong data from a very successful phase three pivotal trial for Daxia Daxia for injections in the treatment of cervical dystopia. Following closely behind is our clinical program for adult limb specificity, which is preparing for phase three.
Research and development expenses for $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 on.
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 cash equivalents and short term investments as of June 32021, or $336.3 million.
Dustin S. Sjuts: For these reasons, we're pleased to announce the appointment of Rob Van Craw as general manager of therapeutics. Rob adds to the strength of our team, bringing more than 25 years of experience in healthcare and life science. He also has a strong background in the therapeutic toxin space. At Allerhand, Rob was instrumental in leading the global pipeline development strategy for Bozox Therapeutics, laying the groundwork for expansion investments like festivity, migraine, neurogenic, and overactive bladder.
Which we believe the sufficient to fund our operating plan into 2024.
Further we reaffirmed our previously announced 2021 guidance.
For 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 Toby and.
In closing, we're very proud of our performance for the first half of the year and anticipate a strong finish in the second half with the potential approval of Dachsie botulinum toxin a for injection and further advancement in our therapeutics pipeline.
We all for me and a solid financial position with sufficient cash to support our growth initiatives into 2020 for with that.
Dustin S. Sjuts: Most recently, Rob was the CEO of Kumenta, a company focused on accelerating solutions for brain diseases. Prior to that, he was the Executive Vice President of Health Point Biotherapeutic. With this strong background and track record, Rob will help strengthen our therapeutic pipeline strategy and advance our clinical development, all of which will guide our franchise through commercialization. The strong team is the infrastructure in place.
I will now open the call up for questions operator.
Thank you as a reminder, the ask a question you May Press Star then the number 1 on the telephone keypad that's true.
1 on the telephone line.
We will have our first question from the line of seamless Fernandez from Guggenheim. Your line is now open.
Well, thanks very much so.
I'll do my 1 question and follow up.
Just the.
Dustin S. Sjuts: We look forward to elevating the value of the Therapeutic franchise and entering the growing $2.3 billion global therapeutic hermodiated market. With that, I'll turn the call back over to Mark to discuss our upcoming pipeline milestones. Mark?
Kick off with the first question.
Abbvie really.
Under the al again.
The moniker.
Really delivered a very very strong second quarter. Congrats on your guidance second quarter, 1 thing that they commented on.
Mark J. Foley: Thanks, Dustin. We are anticipating two key milestones in our therapeutic pipeline during the second half of the year. As Dustin mentioned, we are currently in phase three clinical trials evaluating doxibachilina toxinate 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. Afterward, we plan on filing a supplemental biologics license application in 2022, with anticipated approval in 2023. Our clinical team is also preparing for a phase three program in adult upper limb spasticity.
Was that they anticipated debt approximately 2 thirds of the.
The demand was regular way demand and then about 1 third 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 have 1 other follow up question.
Thank you for this 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 of 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 theres definitely a pretty healthy backlog on so we're talking with the there's no doubt there is some pent up demand there is clearly some new.
Mark J. Foley: Do recall that we completed our Juniper phase two study in February this year, and our plan remains to hold end of phase two months commercial activities for Daxibachyana and toxin A for injection. SGNA expenses include depreciation and amortization and stock-based compensation; excluding these expenses, non-G&A expenses, or $42.4 million. Research and Development expenses were $29.4 million for the second quarter, reflecting costs related to clinical trials, regulatory support for the ongoing biologics license application, pre-commercial manufacturing, and our fintech platform development.
Consumers that are entering the market somewhat of the zoom effect on everything else and we feel very good that we've returned at least for now back to levels that were pre pandemic and Joe certainly of we would expect that we will 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 that you can tell with the.
The roughly 2000 or so of accounts that were in between our products and services that were being pretty targeted.
Clearly, we're seeing a nice healthy market right now.
Great and then just as the 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 is going.
Women Leigh maybe you could just give us the 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.
Mark J. Foley: R&D expenses include depreciation and amortization and stock-based compensation; excluding these expenses, non-GAP R&E 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 30th, 2021, or $336.3 million, which we believe is sufficient to fund our operating plan into 2024. Further, we reaffirmed our previously announced 2021 guidance of approximately 71.8 million, with 76.7 million fully diluted shares, excluding the impact of convertible death.
Through the balance for you know, 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 of where we're at now consistent with prior commentary indicated that prior to or produce the day everything had been addressed except for the on site inspection as part of our AI.
On where we press released and inspection day had not been scheduled yet and then in June the FDA delays, we were at a bit of a holding pattern waiting for that to occur given that this is there for drug approval.
Note inspection without a possibility in the we're going to need to physically inspect the plant.
On the spring put out a press release that we had been given an inspection day to occur before the end of Q2.
Our press release and in our remarks on the FAA has shown up at our facility. So we continue to feel very good that they're following sort of through with you on the east.
Mark J. Foley: And with that, I'll turn the call back over tomorrow. Thank you, Toby. 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 Daxubotuline and toxinate for injection and further advancement in our therapeutic pipeline. We also remain in a solid financial position with division.
The expected inspection plan.
Yes, I think youre assessing consistency with our talent around the expected approval before year end on Wednesday.
The advantage of this time to keep up sort of our readiness for the inspection and continue to <unk>.
Advance our commercial preparation plants in.
In terms of the launch trajectory. We've also tried to be consistent this will be the the first time that our product has been used outside of clinical trials and as the results, we're going to be sort of very thoughtful intentional.
Operator: Thank you. As a reminder, to ask a question, you may press star, then the number one on your telephone keypad. That's star one on your telephone. We will have our first question from the line of Seamus Fernandes from Guggenheim. Your line is now open.
And the first phase of our launch.
Excuse me similar to what we did with the <unk> filler line and so I think for the balance of.
This year likely in post approval, we're going to spend most of our on focusing on ensuring.
We're going to get really good reproducible outcomes that are consistent with our clinical trial data and that for commercial launch is likely to be much more of of 2022 phenomenon. So that's how we're thinking about it but there will be the stub period post approval, where we are going to need to spend some time with a select group of customers the real world commercial experience before going through our more.
Seamus Christopher Fernandez: Oh, thanks very much. So I'll do my one question and follow-up, but just to kick off with the first question, you know, Abbe really, under the Allegan moniker, really delivered a very, very strong second quarter. Congratulations on your guys' second quarter.
Traditional watch.
Great. Thanks for your question.
Thank you and now the next question comes from the line of Terence Flynn from Goldman Sachs. Your line is now open.
Seamus Christopher Fernandez: Congratulations on your guys' second quarter. One thing that they commented on was that they anticipated that approximately two-thirds of the demand was regular-way demand, and then about one-third was pent up. Would you guys maybe just comment on your thoughts around that statement and, you know, what it means relative to, you know, 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. This is Mark.
Great. Thanks for taking the questions maybe just 1 follow up mark on the Dax the manufacturing side in the past I think you've noted about a 6 to 10 week timeline.
For a turnaround from the agency just wondering if that's still your expectation and the.
Obviously, a strong quarter for the filler side.
Here, so and obviously breath contributed but just wondering what youre seeing from the reorder side of things. Thank you.
Okay.
Mark J. Foley: I don't know that we've got any sort of better data than that. You know, we're in the launch phase, so obviously, the accounts we're dealing with represent sort of a smaller fraction of the overall market. Having said that, I would say that, you know, 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 heightened demand.
Just the first half we.
In terms of it didn't get sort of a set timeframe because were outside of the produce the clock.
We're within the produce of framework everything is moving towards the deadline.
Hard to know exactly the timeframe that the agency is going to work on there as it relates to the inspection clearly are trying their best I think to resolve any of these outstanding issues and so we continue to stinker of commentary that we're focused on on approval certainly for the end of 2021 and have full preparation and build schedule of <unk>.
Mark J. Foley: There's clearly, you know, some new consumers that are entering the market, somewhat as a Zoom effect and everything else. And we feel very good that, at least for now, we've returned, at least for now, to levels that were pre-pandemic. And, you know, 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, you know, roughly 2,000 or so accounts that we have between our products and services that were pretty targeted. But clearly, we're seeing a nice, healthy market right now. Great, and then just as a second question very quickly on just, obviously, you're expressing a high degree of confidence in the launch.
Going on in the interim.
Regarding that the filler and reorder rates I think it's still a little early for us to.
The make a lot of commentary around the doses are our third full quarter of launch that we still are seeing the cycle of the accounts coming on line and figuring out where it fits in their practice and then we also expect.
With the approval of our neuromodulator that has kind of introduced another new dynamic in there that.
<unk> changed a little bit of sort of the percent of the.
The business on accounts willing to consider giving to us which accounts might be willing to lean in net were otherwise waiting until we had to pull back. So I think it's still a little bit early as certainly as we get visibility.
City 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 for we still think work for a little bit early on that process.
Great. Thanks next question.
Thank you. Our next question comes from the line of kind of Louis Chamois from Stifel. Your line is now open.
Seamus Christopher Fernandez: 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
Hi, guys. Thanks for taking my question.
Just a little bit more on the commercial.
Preparations for doing ahead of the approval what are you able to day, obviously penetrated of data.
Seamus Christopher Fernandez: 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 of 2022. Or, you know, maybe just without guidance specifically, but just kind of the rollout through the balance of 2022. Thanks.
On the amount of accounts is there anything that you can do outside of it.
The potential training and education, such as the commercial work contracting where preliminary contracting preliminary negotiation.
Any of that stuff I can happen ahead of time that could potentially have smoothed the process for the launch not pull away.
Mark J. Foley: You know, first on the FDA process and where we're at, consistent with prior commentary. We indicated that prior to our producing a date, everything, you know, had been addressed except for the on-site inspection as part of our PAI, where we released a press release 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 was not a possibility, and they were going to need to physically inspect the plant.
Too much of the energy from.
On the filler.
Mentum that youre, having and then on the manufacturing side.
I realize that.
<unk> said that this is the process.
And so I imagine that means theres a bit of of back and forth.
If there are any issues on that.
Would you be telegraphing any of that or is it just you're keeping it as part of the process and they're still on board for second half of that's about all of your and the same thing.
Mark J. Foley: We then, in the spring, put out a press release that we'd 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, you know, they're following sort of through with the expected inspection plan. Yes, I think you're sensing consistency with our tone around the expected approval before year end.
Yes, the first on many of 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 you know we've continued to refine our pricing strategy and more market research work that we've been doing.
We've taken advantage of this of this gap between the launch of the pillar <unk>.
The expected approval of the neuromodulator.
Mark J. Foley: And we've taken advantage of this time to, you know, beef up sort of our readiness for the inspection and continue to, you know, advance our commercial preparation plans. In terms of the launch trajectory, you know, 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.
Bill for inter relationships with physicians at the customer level. So we're continuing to establish the prestige revamped the threat of the aesthetics brand I think people see us now as a company that's working towards a broader range of products both from a services on a product stage.
And then obviously, we talked about building inventory in advance of launch so a lot of the launch prep is internal activities getting all of our sales materials ready and everything to support that so that's that's kind of more of what we're doing on the commercial prep side, you're on the matter of manufacturing side, we kind of broke protocol and commenting on where we were in our FDA journey.
Mark J. Foley: Excuse me, similar to what we did with the RHA filler line. And so I think for the balance of, you know, 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 you know 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 step period post-approval where we are going to need to spend some time with a select group of customers getting real world commercial experience before going through a more traditional launch
Given the pandemic when we talked about the fact that of inspection had not been scheduled prior to the <unk>.
And then again, putting out a press release of what had been scheduled to occur before the end of June So I wouldn't read into my commentary about the process. This is sort of a standard the piece that needs to happen before approval.
So the next communication you will hear from US is kind of once we get the FDA decision, but again.
Back to the fact that we built.
Very good about our prep and where we were in that process and we continue all of our preparations.
In the in the hopeful approval of crop.
Yeah.
Okay.
Yeah.
Next question.
Thank you. Our next question comes from the line of David <unk> from Piper Sandler. Your line is now open.
Operator: Thank you. And now our next question comes from the line of Terrence Flynn from Goldman Sachs. Your line is now open. Great.
Hey, Thanks. So first question is.
On the sellers.
I don't know if you've talked about this in your prepared remarks, I'm, sorry, if I missed it but can you just talk about.
Terence C. Flynn: Great, thanks for digging into the questions. Maybe just one follow-up mark on the Daxi manufacturing side. In the past, I think you've noted about a six to ten-week timeline 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 on the reorder side of things. Thank you.
The the mix.
On the the different Skus are there any of their predominating.
Are there any of that of gain particular traction or the practices of a real affinity for thus.
Thus far I know.
It's sort.
Still relatively early in the commercial life on these early days, but you know.
Mark J. Foley: Because the first off, you know, we intentionally didn't give sort of a set time frame because we're outside of the Padoof o'clock, where within the Padofa framework, you know, everything is moving towards a deadline. You know, it's hard to know exactly the timeframe 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 outstanding issues.
As things evolve you know what are you seeing out there in the field.
So that's the number 1.
And then number 2 can you just remind us on on Dachsie once you get approval.
What's what sort of net are you going to cash in terms of.
On the training of the injectors in other words how.
How many should we expect you to of trained within the first 6 in say 12 months.
Mark J. Foley: And so, you know, we continue to stick to our commentary that, you know, we're focused on an approval, certainly before the end of 2021, and we 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, so we are still seeing the cycle of accounts coming online and figuring out where it fits in their practice.
Of the.
Of the commercial life of DAC C L.
And over time should we expect some sales force expansion.
Given that there are more injectors of neuromodulators than there are <unk>.
So how should we think about that thanks.
Great. Thanks, David So the first 1 on the mix side of it we didn't address those on our scripted comments. The previously what we said last quarter was that it was roughly a third a third of third we're not seeing of major shifts between Q3 and for.
Mark J. Foley: And then we also expect, you know, with the, you know, approval of our neuromodulator, that's going to introduce another new dynamic in there that, you know, may change a little bit the percent of the business and accounts willing to consider giving to us, which accounts might be willing to lean in that we're, you know, otherwise waiting until we have a full bag. So I think it's still a little bit early. Certainly as we get visibility and have data that we think is more
We're still early I think people are still figuring out in and I've been surprised of when we've been out of the field kind of the the.
Of the range of places that that people are using it obviously, we're limited to focusing on indications on the <unk> lines, but.
I think the refining of used.
Use this.
For different performance characteristics and you'll hear from 1 party that they liked the performance characteristics of.
Of our G suite with somebody else on our 8-K for so right now it's still pretty even I am sure will cease of separation over time, but right now it continues to be pretty evenly split the third a third of third.
Operator: Thank you. Our next question comes from the line of Annabel Sammy from Stifall. Your line is now open. Hi, thanks for taking my question.
In terms of of.
Our neuromodulator and kind of how we're thinking about the launch in 6 to 12 months post launch.
We remain committed to the kind of the prestige and targeted strategy and what we've talked about before as debt.
Annabel Eva Samimy: 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
Out of the out of the 30% to 40000 injector accounts that we can do or are in the U S of top third of those are really the target that we're going after and that we would expect over time to be roughly half of that top third so right. Now. We're in 2000 accounts those are obviously going to be sort of on our bias accounts to go after first because the.
Annabel Eva Samimy: a decent number of accounts. Is there anything that you can do outside of, you know?
Annabel Eva Samimy: potential training and education, such as commercial work, contracting work, and preliminary contracting
The leaned in with our JV because of the prestige strategy. They like the idea of no pricing and so that's the the same group of customers that we expect of and 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 the target over time, I think that starts getting a little bit more towards guidance, but.
Annabel Eva Samimy: 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...
Annabel Eva Samimy: manufacturing side. I realize that, you know, you said that this is a process. And so, you know, I imagine that means that there's a bit of a back and forth.
Phase 1 is going to be make sure that as the products used for.
Commercially that debt were building from a position of strength in terms of the outcomes and then after that we will sort of more broadly introduce it certainly to the prestige accounts that have already expressed an interest with us and.
Annabel Eva Samimy: 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 the second half, and that's about all you're going to say? Yeah, 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 approvals. So when we talk about commercial prep, it's all around, you know; we continue to refine our pricing strategy and more market research work that we've been doing.
And then there is no doubt that there will be a broader number of accounts that I think are going to have an interest of leaning in with us once the neuromodulator group.
Yeah.
Great. Thanks.
Alright. Thank you. Thank you.
Thank you. Our next question comes from the line of Tim Lugo from William Blair. Your line is now open.
Thanks for taking my question and I know most.
Most of them on the phone, who probably has a question over the past.
2 years.
Annabel Eva Samimy: You know, I think that we've taken advantage of this gap between the launch of the filler and the expected approval of the neuromodulator to build further relationships with positions at the customer level. So, you know, we're continuing to establish the prestige revans as a threat aesthetic brand.
Debt ahead of hopefully an approval on launch of debt.
I just wanted to revolve.
On the thoughts around physicians and how they want to see the patients more often the less often and agree with that view, but could you just refresh us with kind of what are you hearing from physicians, who have used that from the clinical trials.
Mark J. Foley: 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 a lot of the launch preparation is internal activities, getting all our sales materials ready and everything to support that. So that's kind of more of what we're going to do. we're doing on the commercial press side.
And maybe some of the interest youre hearing from the field from our U K marketing.
Just really an update on that thought.
A long duration.
Both of the short acting neurotoxin in the timing around that.
Okay.
Yes.
Tim as it relates to sort of the.
The long duration profile that we've seen on our clinical trials with our neuromodulator and sort of how that might fit into clinical practice to be impacted couple of day.
Mark J. Foley: On the manufacturing side, you know, 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 an inspection had not been scheduled prior to the PDUFA. And then again, putting out a press release that one had been scheduled.
The points that will bring out the there's a lot of market data out there that despite congressional neuromodulators lasting kind of 3 months for months debt average consumers only come in sort of 1.9 times of year for less so first and foremost we think figures in very well for what the normal pattern of consumers second.
Operator: Thank you. Our next question comes from the line of David Amsalam from Piper Sandler. Your line is now open.
For you, particularly with the prestige accounts that we're going after when we've been out in the field. The stopes if anything have long waiting lists and so getting into these accounts is the challenge so Europe provider of.
David A. Amsellem: Hey, thanks. So the first question is on
The only way that you can necessarily increase sort of the services that you offer to your patience for increased profitability and so if you can do more service the same setting in a neuromodulator treatment every twice a year its really well with also providing pillar as well for this idea that you can add sort of both the pillar of Neurotoxins.
David A. Amsellem: My first question is on the fillers. I don't know if you've talked about this in your prepared remarks, I'm sorry if I missed it, but can you just talk about the mix among the different SKUs? Are there any of them predominating, or are there any that have gained particular traction or that practices have a real affinity for thus far?
Gather to give better outcomes for patients and increase the per visit ticket makes it kind of SaaS 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 of the last thing I would say is innovation for us underpins everything, but what that does also creates choice.
David A. Amsellem: I know it's still relatively early in commercial life and these early days, but, you know, as things evolve, what are you seeing out there in the field? So that's number one. And then number two, can you just remind us about Daxi: once you get approval, what sort of net are you going to cast in terms of training injectors? In other words, you know, how many should we expect you to have trained within the first six and, say, 12 months of the commercial life of Daxi? And over time, should we expect some Salesforce expansion, given that there are more injectors of neuromodulators than there are of fillage? So how should we think about that thing? Great, thanks, David.
Creates more choice of the physician level and on the consumer level and so with the longer acting neuromodulator, we're not trying to be everything to everybody and so there are consumers of the practice that prefer coming in 3 or 4 times a year and that's the cadence that they want the practice of it that's great but based on our market research. We think there is a not insignificant number of consumer.
That really will put a premium on a neuromodulator that lasts longer and so we think practices being able to provide choice figuring out what fits makes a lot of sense. So we continue to feel really good about the value proposition and how this is going to fit in the practices, but from a consumer demand and from a profitability standpoint.
Mark J. Foley: So the first one on the mixed side of it, we didn't address that in our scripted comments, but previously, what we said last quarter was that it was roughly a third, a third, a third. We're not seeing a major shift between two, three, and four. We're still early.
That's great to hear thank you for clarifying and maybe my 1 follow up.
In the therapeutic category.
Don't understand why of long duration.
Mark J. Foley: I think, you know, people are still figuring things out. And I've been surprised when we've been out in the field, kind of the range of places that people are using them. Obviously, we're limited to focusing on indications on the glabella lines, but, you know, I think that we're finding folks use this for different performance characteristics. And you'll hear from one party that they like the performance characteristics of RHA2 and somebody else on RHA4. So right now, it's still pretty even.
All of it would not the would not capture the majority of share of eventually.
In the case, Mike cervical dystonia.
Yes, I know youre, obviously, adding to the kind of cute.
Side of your franchise.
With the additional but can you maybe talk to some of the market research.
Mind us about the micro research indicated for you to play.
Sure Timna on I would say that's sort of aware of market research shows as well it actually shows that in the therapeutic area that we could become a share of leader on when I think it speaks to the fact that these are the debilitating diseases and that the ability to reduce the for.
Mark J. Foley: I'm sure we'll see some separation over time, but right now, it continues to be pretty evenly split, the third and third of third. In terms of, you know, our neuromodulator and kind of how we're thinking about the launch in, you know, minutes, it's kind of this prestige and targeted strategy. And what we've talked about before is that, you know, out of the kind of the 30 to 40,000 injector accounts that we think there are in the U.S., a top third of those are really the targets that we're going after, and that, you know, we would expect over time to be in roughly half of that top third.
Frequency of visits.
Obviously, it gets prolonged symptom relief, but it also takes some stress off of the system right. It's less facilities, the physician time and everything else.
Mark J. Foley: So, you know, right now we're in 2,000 accounts. Those are obviously going to be sort of our biased 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 you know, phase one is going to be make sure that,
Operator: Thank you. Our next question comes from the line of Kim Lugo from William Blair. The line is now open.
Timothy Francis Lugo: Thanks for taking the question. And I know most people on the phone have probably heard this question over the past few years.
Timothy Francis Lugo: But ahead of, hopefully, an approval and launch of Daxi, I just wanted to revive 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 Dax in the clinical trials and maybe some of the interests you're hearing from the field from RHA marketing. And just really an update on that thought of a long duration asset versus a short acting neurotoxigen and the excitement around the Yeah, so tend as it relates to sort of the long duration profile that we've seen in clinical trials with our neuromodulator and sort of how that might fit into clinical practice in terms of impact
Thanks.
Yes.
We've reported for the total number provided accounts between our services platform in our products, which starchy product line at the end of of each quarter of so we talked about there being over 500 at the end of Q3 over a thousand at the end of the queue for over 1500 at the end of the Q1 and now over 2000 at the end of the queue too. So we've been.
The averaging 500, or so new accounts as per quarter.
Obviously with some of the new products of programs that we have coming out of all need to sort of look to say is account activation as important as settling for making sure that with some of these new services that were going deeper than the existing accounts, but I think those of reasonable numbers for now I think posted approve of our neuromodulator, we'll need to revisit that because again our strategy is much more of.
Mark J. Foley: Yeah, as it relates to sort of, you know, the long duration profile that we've seen in clinical trials with our neuromodulator and sort of how that might fit into clinical practice, and the impact of a couple data points that will come out. You know, there's a lot of market data out there that despite conventional neuromodulators lasting, you know, kind of three months, four months, average consumers only come in sort of 1.9 times a year or less. So, first and foremost, we think it figures in very well.
Versus the deeper we clearly have a lot of the rubber room in the accounts that we view to be on target market opportunity, but Joey the with this tracking right now it's not unreasonable the sort of look at 500 of new account as per quarter as something that could could continue to exist for the balance of the year.
Thanks, Mark that's helpful and maybe a quick on on.
From <unk> from the both of the just the way our both your.
Mark J. Foley: Secondly, particularly with the prestige accounts that we're going after, when we've been out in the field, these folks, if anything, have long waiting lists. And so getting into these accounts is the challenge.
Mark J. Foley: And so if you're a provider, the only way that you can necessarily increase the services that you offer to your patients for increased profitability is if you can do more services at the same setting. And a neuromodulator treatment every, you know, twice a year fits really well with also providing filler as well. So this idea that you can add some sort of both filler and neurotoxins together to give better outcomes to patients and increase the per visit ticket makes a ton of sense.
Mark J. Foley: So in the customers that we're talking to, and obviously, we've got a bias towards those that are leaning towards the prestige strategy, it resonates a lot. The last thing I would say is, innovation for us underpins everything, but what that does also creates choice, creates more choice at the position level and 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 the practice that prefer coming in three, four times a year, and that's the case that they want, and the practice wants it.
Mark J. Foley: 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, you know, practice is being able to provide choice and figure out what fits 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, but from a consumer demand and from a profitability perspective.
The safety profile of the product and how patients respond to again the 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.
Yeah.
Okay.
Secondly.
With the addition of the raw Bancroft for the Therapeutics team should we look at that as the kind of confirmation that you're moving forward with the commercialization.
Mark J. Foley: That's great to hear. Thank you for clarifying. And maybe my one follow-up. In the therapeutic category, I just don't understand why a long-duration product would not be, or would not capture a majority of share eventually in an indication like cervical dystonia. I know you're obviously adding to the therapeutic side of your franchise with the addition of Rob, but can you maybe talk about some of the market research and remind us about the market research for the therapeutic side? Sure, and I would say that's sort of a wearable market.
Commercialization effort for the muscle movement disorder in the room.
For the commercial partnership.
Yeah. That's correct you know in addition to Rob We also announced last quarter. The addition of <unk>.
And other senior level person on the health care reimbursement side of it so that we're focused on count on that as well and so we've long talked about our focus on building out.
Sort of of direct sales force and the muscle movement of space and these are some of the key features that we're putting in place to allow us to access and enter that market.
Mark J. Foley: Sure, I would say that's sort of what our market research shows as well. It actually shows that in the therapeutic area, we could become a shared leader. I think it speaks to the fact that, you know, these are debilitating diseases and that, you know, the ability to reduce the frequency of visits obviously gives prolonged symptom relief, but it also takes some stress off of the system, right? It's, you know, less facility fees, physician time, and everything else.
As it relates to cervical dystonia, we've talked about of filing in 'twenty, 2 and an approval of <unk> 23, So it's not too far away and we believe that theres, a fair bit of of opportunity to be unlocked there and as we've talked previously we think that the performance profile of our product will allow us to be very competitive in the therapeutic category.
Thank you.
Okay.
Thank you. Our next question comes from the line of Ken <unk> from Keybanc. Your line is now open.
Mark J. Foley: And so, you know, if you look at the data that we generated from our CD program, not only was the duration profile really strong, but we had a very encouraging safety signal as well with low dysdacia rates. And so, we really are optimistic about our neuromodulator performance in clinical trials and therapeutics. And so that's why we announced some of the new hires that we have, you know; we're starting to get ready for commercial introduction of our, you know, cervical dystonia.
How're you doing team congratulations just really great performance without yet having back seat so.
As we think for it I know Marc you want to be thoughtful in terms of how the product is rolled out and the experience of 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 debt, maybe you all could occur.
Operator: Thank you. Our next question comes from the line of Balaji, Prasad, from Barclays. Your line is now open. Again, our next question comes from the line of Balaji Prasat. Your line is now open.
Fly or as you step back and look at the overall marketplace.
Balaji V. Prasad: Hi, good afternoon, everyone. Thanks for the questions. Apologies if this has been asked before, but I just want to go back to the number of accounts open this quarter, or net accounts opened in 2000, 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.
In terms of timing for you all in D. T C and really differentiating this product as we think through maybe the the 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 of the in the future of thanks. So much.
Mark J. Foley: Yeah, thanks a lot. You know, we've reported the total number of my accounts between our services platform and our products, which is the RHA product line at the end of each quarter. So, you know, we talked about there being, you know, over 500 at the end of Q3, over 1, over 1,000 at the end of Q1, and now over 2,000 at the end of Q2. So we've been, you know, averaging 500 or so new accounts ads per quarter.
Sure. 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 pushes the training new injector, so theyre going to expand sort of the number of folks that are actually doing toxin treatments of 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 and help grow the overall market. So we would expect that they're going to continue to.
To run their playbook, which is more awareness dollars for couponing of customers' training of new injectors of all of which will help grow the market and as we come into the market with innovation.
Mark J. Foley: Obviously, with some of the new products and programs that we have coming out, we'll need to sort of look to say, his account activation is important, is doubling back, and making sure that with some of these new services that we're going deeper into the existing accounts, but I think those are reasonable numbers for now. I think post-improvement of our neuromodulator will need to revisit that because, again, our strategy is much more versus deep versus wide.
We will also drive for consumer awareness for coming in but ours is going to be much for focused again on these kind of prestige and of high end practices. So we.
We don't expect a whole lot of different in terms of the way that we view the market certainly once we hit the market.
Mark J. Foley: We clearly have a lot of run room in the accounts that we view to be our target market opportunity, but, you know, with this tracking right now, it's not unreasonable to sort of look at, you know, 500 new accounts per quarter as, you know, something that's achievable.
Mark J. Foley: Thanks, Mark, that's helpful and maybe a quick one on bias in the Botox to just see where you are post your resubmission or submission Sorry, this with regard to the FDA data data package that was submitted a couple months ago.
Mark J. Foley: But we continue to be encouraged by the dialogue that we have 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 you're in.
Operator: Thank you. Our next question comes from the line of Search Belanger from Needham and Company. Your line is now open.
Serge D. Belanger: Hey, good afternoon. Thanks for taking my questions.
Serge D. Belanger: 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. For example, in the open-label safety study, it was really a dose escalation study looking at, you know, the primary end point there was to look at the safety of, you know, sort of repeat doses over time.
The margin stream of the of credit card processing. It is the the big advantage of that gives us the access to the sort of level of data. So right now the the NMD system is.
Robust credit card processor, but it doesn't necessarily give us access to the source of all of the data. So things are on data analytics and insight and even automating.
Subscription services in a way that seamless and easy to setup and white label loyalty become a lot harder. If you don't have access to the source data. So maybe becoming a payment of facilitator. We then are able to scrape debt source data, which again it'll be the practices information, but then we can turn around and use that to help them with data insight on annulled.
Serge D. Belanger: And so when we report that out, it's much more of a look at the safety profile of the product and, you know, how patients respond to, again, these different doses that occur over time and increase in doses if that's what the clinician ultimately decides. 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 on. And secondly, with the addition of Rob Bank.
<unk> and so that's that's really the key functional functionality, that's going to have to work very encouraged with all of the the debate of launch fat 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 it 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 it back to the practices.
On the migraine side of it to your of what we've talked about it sort of not if in the winter I think what we said most recently is that we would sort of consider this is part of our of 2022 planning cycle and so will will be better prepared to address sort of our migraine fits into our overall therapeutics strategy and what priorities that we have ultimately.
Serge D. Belanger: To the therapeutics team, should we look at that as
Serge D. Belanger: kind of confirmation that you're moving forward.
Serge D. Belanger: with a commercialization effort for the muscle movement disorder.
For 2022, when we give a little bit more Colorado Springs corporate.
Serge D. Belanger: movement disorder, and you're in a commercial partnership. Yeah, that's correct.
Mark J. Foley: Yeah, that's correct. In addition to Rob, we also announced last quarter the addition of another senior-level person on the healthcare reimbursement side of it, so we're focusing on that as well. And so, you know, we've long talked about our focus on building out, you know, sort of a direct sales force in the muscle movement space. And, you know, these are some of the key pieces that we're putting in place to allow us to access and enter that market.
Okay alright, thank you.
Okay. Thanks, Paul.
Thank you. Our next question comes from the line of them Yeah from HSE Lane right in the line is now open.
Alright, everyone Christy all the chair on for a dog. So congrats on the quarter on so I was just a little bit interested in the prestige Craig Mitchell targeting would pradaxa the amount will compare the of yours is the heavily targeting the millennial demographic and I was just wondering how much overlap there is between these 2.
Mark J. Foley: You know, as it relates to cervical dystrophy, we've 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.
Thanks.
I think we use of.
Right of the segregation of on a consumer and as the branch around the track.
Operator: Thank you. Our next question comes from the line of Ken Cassiatori from Calvin. Your line is now open.
Those force the strategy of around our focus on partnering with those practices that drive value for the.
The provider of patients as well as the outcome of the price of fish. So those practices of Asian type.
Ken Cassiatori: How are you doing, team? Congratulations, just a really great performance without yet having Daxi.
Of those might be millenniums, and waved at all of the sweet or.
Ken Cassiatori: So as we think forward, I know Mark, you want to be thoughtful in terms of how the product is rolled out, the experience, and the initial experience, some of the kind of key users have. Can you talk a little bit about now that Abbe 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 market, position 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?
It's really different from the other than that we believe we build the most of the amount of oil revenue to those practices by providing a strength.
The biggest product and then the consumers that thanks for you to be loyal to the practice are low drooling like the driving to those price.
So the those references the.
Ultimately the meals that will be coming to the stages the questions.
Awesome, that's very helpful. Thank you.
Baker.
Thank you.
Again as a reminder to ask a question of you will need to <unk> and the number 1 on your telephone.
The star 1 on your telephone keypad.
We don't have any further questions I would now like the hand, the call back to Mark Foley.
Ken Cassiatori: Is there any kind of nuances you can give us as you approach this market that maybe have been different in the past that we're going to try to do a little bit differently in the future? Thanks so much.
Thank you operator before I, even make my closing comments I just wanted to recap some of our third of our therapeutic milestones for the second app understanding of set the.
So on volume for that section was the grades so in the second half we expect the second half of this year, we expect to share the results of our App physical the label long term safety study afterwards, the plan on file of of supplemental biologic flight application in 2022 with anticipated in 2023 and again that's for our circle the stoning program.
Mark J. Foley: 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 the number of folks that are actually doing toxin treatments. Our strategies are a little different, right? We're going after sort of the top of the pyramid on that side of it.
And then our clinical team is also preparing for based free program and adult upper level of spastic, you'll recall the we completed the arcade of her face to study in February of this year at our play remains to hold of interface to meeting with the FDA before year end.
Mark J. Foley: But I think, you know, all of these things happening in concert are no doubt going to help grow the overall market. So, you know, we would expect that they're going to continue to run their playbook, which is, you know, 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, you know, we will also drive more consumer awareness, 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 to be 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 you know,
So to close things out in the coming months, we plan to virtually tens of city in Wells Fargo healthcare conferences. We welcome your request for meetings of these events for directing true us feel free to reach out to Jessica if you'd like to schedule. Some time with that I think all of the room for participating in today's call.
Ladies and gentlemen, this concludes today's conference call. Thank you for participating in the know disconnect.
[music].
Operator: Thank you. As a reminder, to ask a question, you will need to press star, then the number one on your telephone. That's star one on your telephone. Our next question comes from the line of Vamil Devon from Mizuho. Your line is now open.
Vamil Devon: Great, thanks for taking the questions. So maybe just a couple from me. One on the PAYPAC integration that you've talked about for next quarter. Can you maybe just provide a little more insight into the benefits you think that's going to provide for that side of your business?
Vamil Devon: Part would just be maybe any update you might have around your efforts or on migraine. And you've talked about that being a matter of sort of when you work on that as well, if you work on that, but just curious if there's anything new as has that market office, which is evolving pretty rapidly as well. So any new thoughts will be helpful, thanks. Great, thanks. First on the Payback side of it, you know, the real advantage of payback, in addition to participating in more of the overall margin stream of the credit card processing, the big advantage is that it gives us access to the source level data.
Vamil Devon: So right now, the HintmD system is a robust credit card processor, but it doesn't necessarily give it access to the source level data. So things around data analytics and insights and even automating some sort of subscription services in a way that's, you know, seamless and easy to set up and white label loyalty become a lot harder if you don't have access to the source data. So by becoming a payment facilitator, we are then able to scrape that source data, which will be the practices' information, but then we can turn around and use that to help them with data, insight, and analytics.
Vamil Devon: And so that's really the key functionality piece that's going to enhance it. So we're very encouraged with how the beta launch of that is going and how it's being prepared. And again, that will be sort of the foundation that we 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, you know, if we choose to hold on to that or, you know, if we choose to give it back to the practices.
[music].
Vamil Devon: On the migraine side of it, you know, to your point, we talked about it, sort of not as 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 fits into our overall therapeutic strategy and what priorities that we have ultimately for, you know, 2020 when we give a little bit more color on our 2020 operations.
Mark J. Foley: Okay, all right, thank you.
Operator: Thank you. Our next question comes from the line of Dog Tiao from H.C. Wainwright: "Airline is now open."
Chris Shibutani: Hi Chris Bialis here on behalf of Doug Sow. Congratulations on the Quarter. So I was just a little bit interested in the prestige segment that you're targeting for Daxi. Now, a competitor of yours is heavily targeting the millennial demographic, and I was just wondering how much overlap there is between these two segments. Thanks.
Mark J. Foley: Hey Chris, I think we need to separate the segmentation around consumer and then separation around practice. So the perceived strategy is around our focus is really on partnering with those practices that drive value in the experiences they provide their patients as well as the outcomes they provide their patients. So those practices see all patient types. Those might be millennials and lay it all in between.
Mark J. Foley: So our strategy is really different from the others in that we believe we can build the most of the most of the types of amount of loyalty directly to those practices by providing that experience with us and great innovative products. And then the consumers that they treat are loyal to the practice. So our loyalty really lies in driving it to those practices. So those practices will see all the millennials that will be coming into the space just as much as the
Chris Shibutani: Awesome, that's very helpful. Thank you.
Operator: Thank you. Again, as a reminder, to ask a question, you will need to press star, then the number one, on your telephone. Let's press star one on your telephone keypad. We don't have any further questions. I would now like to hand the call back to Mark Foley. Thank you, operator.
Mark J. 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.
Mark J. Foley: So in the second half, we expect, second half this year, we expect to share the results from our Aspen, open label, long-term safety study. Afterward, we plan on filing a supplemental biologic license application in 2022, and then Tisipaget in 2023, and again, that's for our cervical dystonia program. And our clinical team is also preparing for a phase three program in adult upper limb spasticity. You'll recall that we completed our Juniper Phase 2 study in February this year, and our plan remains to hold an end of phase two meeting with the FDA before year end.
Mark J. Foley: So to close things out, in the coming months, we plan to attend the virtual Wells Fargo healthcare conferences in this city. We welcome your requests for meetings at these events through us. Feel free to reach out to Jessica if you'd like to schedule some time. With that, I would like to thank all of you for participating in today's call.
Operator: Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.
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Operator: Good morning everyone. Welcome to RELAN's Therapeutic Second Quarter 2021, Financial Assault, and Corporate Update Conference Call. At this time, all participants are in a listen-only mode. Following the management's prepared remarks, we will hold a Q&A session. To ensure that we will have ample time to address everyone's questions during Q&A, we would like to ask for a limit of one question and one follow-up question per person.
Jessica Serra: To ask a question during that time, please press Star, followed by one on your touchtone phone. If anyone has difficulty hearing the conference call, please press Star Zero for operator assistance. As a reminder, this call is being recorded today, August 5, 2021. I would now like to turn the conference over to Jessica Tara, Head of Investor Relations and ESG for Rivens. Please go ahead, and joining us on the call today is Maria, President and Chief Executive Officer of Monopoly. She's the financial officer,
Unknown Executive: I'm president of innovation and technology operations Where is a common call, management only forwards statements.
Unknown Executive: potential benefits of our drug-cotic candidates and technology.
Unknown Executive: and launch of the next generation FitTech platform, the timing of any potential approval of that Pivajama Top State for injection. 2021 guidance, expected cash runway, These forward-moving states are based on the company's current expectations, and in health, involves specific risks and is not certain; our actual results and the time you know that can differ materially from the anticipated assessment.
Unknown Executive: Also, in today's call, we will present both Gap and Non-Gas Financial Measures. The reconciliation of non-gast net features includes
Mark J. Foley: Just included about those. For that, I would turn to call over to Mark Polar. Thank you, Jessica.
Mark J. Foley: 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 syntax processing volume run rate. Our focus on execution, supported by a 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 Reamance organization working together as a team.
[music].
Mark J. Foley: 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, accioduline, and toxin A for injection for the treatment of clobler lines this year. In the meantime, the remand team is actively building inventory and solidifying our commercial launch plans for this innovative neuromodulator.
Mark J. Foley: We look forward to introducing the first true innovation in their neuromodulator category in over 30 years, and once approved, Daxibotulinin-Aid for injection will not only anchor our aesthetics portfolio but also lay a foundation for our therapeutics franchise. We expect the second half of the year to be very busy and exciting, particularly as we anticipate several catalysts in our therapeutics pipeline, which will be discussed later in this call. With that, I will turn the call over to Dustin, who will discuss the performance of our aesthetics business in the second quarter. Thank you, Mark.
Dustin S. Sjuts: We have built a solid track record of execution since our initial commercial launch. With over 2,000 accounts across 40 states now carrying RHA collections or using our payment platform. This is up from 1,500 accounts in the first quarter. Our consistent results continue to reinforce our confidence and our prestige go-to-market strategy. During the second quarter, through a combination of our sales efforts and injector education, RHA sales increased $17 million, up from $11.6 million in the prior quarter. Growth was also complemented by a seasonally busy period for aesthetic procedures.
Dustin S. Sjuts: As we've done before, Q2 and Q4 are generally more active quarters for aesthetic procedures compared to Q1 and Q3. Given these patterns, expect our rates of revenue growth to be moderated in future, particularly as our Sato team ramps up their training to prepare for the potential commercial launch of Daxi-Botoxin A or injection once approved. We would then expect to return to a seasonally stronger fourth quarter.
Dustin S. Sjuts: Turning to our Stetics FinTech platform, we're pleased to see continued growth in the platform's processing volume run rate, up from over $400 million in Q1 to over $500 billion at the end of Q2. We are also on target and completing the launch of Payfack. Becoming an authorized Payne and facilitator entails excessive testing, controls, and regulations was a big undertaking with the entire organization and a significant accomplishment. We are now well positioned to unlock substantial value in our service ball brain to practice. As a reminder, Payfack enabled us to participate in more of the credit card processing value chain. Further, as a Payfack partner, we'll be able to leverage the source data to build new features and functionality that enhance the overall value proposition of our services offering.
Dustin S. Sjuts: We are now in the market, beta-setting our next generation FinTech platform, which is expected to be commercially launched in the fourth quarter. They're finalizing a rollout 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 activation 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.
Good day, everyone and welcome to events of Therapeutics second quarter, 2021 financial results and corporate update conference call. At this time, all participants are in a listen only mode.
Dustin S. Sjuts: Before I turn the call over to you, I'd like to introduce a few recent key hires across revamped aesthetics and advanced 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 Kada Ansel as a general manager of financial services and our FinTech platform. Kater brings over 20 years of experience designing and building successful consumer products in payments, e-commerce, and financial services for leading organizations, including KUKBai, Citigroup, and PayPal.
Following the managements prepared remarks, we will hold of Q&A session.
To ensure the we will have ample time to address everyones questions. During Q&A, we would like to ask for a limit of 1 question and 1 follow up question for a person.
The ask a question on during that time. The please press star followed by 1 on your Touchtone phone. If anyone has difficulty hearing of the conference call. Please press star zero for operator assistance as a reminder, this call is being recorded today August 5 it's a need for anyone.
Dustin S. Sjuts: Kable will be instrumental in setting our long-term aesthetic services strategy and 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 for therapeutics, we're now at a critical inflection point. We're pivoting our focus to commercial launch preparations, following strong data from a very successful phase-3 pivotal trial for Dr. Bocciana and Toxin A for injection in the treatment of cervical dystopia.
I would now like to turn the conference over at the Jessica Sarah head of Investor Relations and ESG for events.
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Yeah.
On the call today.
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Chief Financial Officer.
Dustin S. Sjuts: Following closely behind is our clinical program for adult limb specificity, which is preparing for phase three. For these reasons, we're pleased to announce the appointment of Rob-Begraff as general manager, therapy. Rob adds to the strength of our team, bringing more than 25 years of experience in health care and life science and impact. He also has a strong background in the therapeutic toxin space. At Out of Hand, Brahma's been instrumental in leading the global pipeline development strategy for Botox Therapeutics, laying the groundwork for expansion investments like festicity, migraine, neurogenic, and overactive bladder. Most recently, Rob was the CEO for Kumenta, a company focused on accelerating solutions for brain disease. Prior to that, he was the Executive Vice President of Health Point Biotherapeutics.
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For any potential losses.
Cash.
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These forward looking statements on based on the current expectation.
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Dustin S. Sjuts: With this strong background and track record, Rob will help strengthen our therapeutic pipeline strategy and advance our clinical development, all of which will guide our franchise through commercialization. With the strong team infrastructure in place, we look forward to elevating the value of the therapeutic franchise and entering the growing $2.3 billion global therapeutic hermodulator market. With that, I'll turn to call back over to Mark to discuss our upcoming pipeline milestones. Thanks, Dustin.
On today's call.
A GAAP to non-GAAP financial measures.
The foundation of non-GAAP GAAP.
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Of that I will turn the call over to Mark Mark.
Thank you Jessica and good afternoon, everyone and thank you for joining our second quarter of 2021 financial results Conference call.
We're very pleased to report strong second quarter results highlighted by $17 million.
And oriented revenue.
So like accounts share across the products and services.
The $500 million instead.
Is that the processing volume run rate.
On the execution supported by healthy set of market led to our third consecutive quarter of revenue growth since becoming the commercial activity and further validated for commercial launch strategy.
These results would not have been possible without the higher.
Mark J. Foley: We are anticipating two key milestones in our therapeutic pipeline in the second half of the year. As Dustin mentioned, we are currently in phase three clinical trials evaluating doxibachialine, an toxinate 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. Afterward, we plan on filing a supplemental biologics license application in 2022 with anticipated approval in 2023. Our clinical team is also preparing for a phase three program in adult upper limb spasticity.
Here, we have of organizations work together.
I think the been impressed by the exceptional talent.
And then to attract to the company.
On your unwavering commitment and dedication to deliver on our objectives.
With the FDA, having initiated their pre approval inspection of our manufacturing facility in June.
The anticipated approval of our lead product <unk>.
Bottom line in talks on a per injection free.
The other lines of this year.
For the Caribbean actively building inventory most of it.
On the solidifying our commercial launch plans for innovative neuromodulators.
We look forward to introducing the first of true innovation in their neuromodulator category and over 30 years and once approved Dr. Botulinum toxin day for injection well not only on for our portfolio.
Mark J. Foley: You recall that we completed our Juniper Phase 2 study in February this year, and our plan remains to hold an end of phase 2, commercial activities for Daxibotiline and toxin A for injection. SGNA expenses include depreciation and amortization and stock-based compensation; excluding these expenses, non-G&A expenses total $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 applications, pre-commercial manufacturing, and our fintech platform development.
Lay the foundation for our Therapeutics franchise.
We expect for the second half of the year to be very busy and exciting, particularly as we anticipate several cash tablets and our therapeutics pipeline with several of our later on this call.
With that let me turn the call over to Doug who will cover the performance of our aesthetics business in the second quarter.
Thank you Mark we have built the solid track record execution since our initial commercial launch low for 2000 accounts across 40 states now carrying the artificial lift.
And order of using our payments platform.
Up from 55 accounts from the first quarter, our consistent results continue to reinforce our confidence.
<unk> go to market strength.
During the second quarter through a combination of our sales efforts and jet for education.
Sales increased $17 million.
From the 11.6 million in the prior quarter gross was also complemented by a seasonally busy period for a set of procedures.
Mark J. Foley: R&D expenses include depreciation and amortization and stock-based compensation; excluding these expenses, non-GAP 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 30th, 2021, or $336.3 million, which we believe is sufficient to fund our operating plan into 2024. Further, we reaffirmed our previously announced 2021 guidance of approximately 71.8 million, with 76.7 million fully diluted shares, excluding the impact of convertible debt.
For Q2 energy for our generally more active quarters for aesthetic procedures compared to Q1 and Q3.
Given the fact that we expect from annual revenue growth to be moderate in the future, particularly as our sales team ramps up the training to prepare for the potential commercial launch that from parts of item of talks for a for injection. Once approved we then expect to return to a seasonally stronger fourth quarter.
Turning to the extent of Fintech platform. We're pleased to see continued growth of the platform is processing volume revenue up from over $400 million in Q1 to over 500 billion at the.
Again for Q2.
We are also on target and completing the launch of a payback the Kevin an authorized the payment facilitator and tail of extensive testing control and regulation.
For the big undertakings of the entire organization is significant the cost that.
We are now well positioned unlock substantial value in our service offering for the practices.
Mark J. Foley: And with that, I'll turn the call back over to Toby tomorrow. Thank you, Toby. 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 a potential approval of Daxibachlina.
As a reminder, payback enables us to participate in more of the credit card processing value chain further as the payback will be able to leverage the source of data to build new features and functionality and enhance the overall value proposition of our sort.
On the software.
We are now in the market beta testing of our next generation Finfet platform with the expected commercially launched from the fourth quarter.
Operator: Thank you. As a reminder, to ask a question, you may press star, then the number one on your telephone keypad. That's star one on your telephone. We will have our first question from the line of Seamus Fernandez from Guggenheim. Your line is now open.
We're finalizing on rollout plan and look forward to share more detail on the new platform share.
Given the technical and commercial preparations underway moving moderating new accounts activation with the launch of the new platform.
Until then we will include both the legacy and the new platform when accounting for our service revenue and payment processing volume run rate.
Seamus Christopher Fernandez: Oh, thanks very much. So I'll do my one question and follow-up, but just to kick off with the first question, you know, Abbe really, under the Allegan moniker, really delivered a very, very strong second quarter. Congratulations on your guys' second quarter. One thing.
Before I turn the call remark I'd like to introduce a few recent the higher across the revamped aesthetics and therapeutics at the <unk>.
Part of our commercial evolution.
Further as part of our commitment to developing our Fintech services segment I am pleased to share the appointment of Kate.
Angela and the general manager financial services, and our Fintech platform.
Brings over 20 years of experience in designing and building the successful consumer product and payments.
Seamus Christopher Fernandez: Quarter, congrats on your guys' second quarter. One thing that they commented on was that they anticipated that approximately two-thirds of the demand was regular-way demand, and then about one-third was pent up. Would you guys maybe just comment on your thoughts around that statement and, you know, what it means relative to, you know, the growth of the market relative to sharetaking as you think about it? And then I'll just, I have one other follow-up. This is Mark.
Commerce, and financial services, and leading organizations, including the Quebec Citigroup on Paypal share will be instrumental in setting our long term instead of services strategy. While also ensuring a smooth the launch of our next generation Fintech platform. We're excited to have her on board and look forward to leveraging current leadership and experience is.
We continue to evolve and grow index franchise.
As for Therapeutics, we're now on the critical inflection points, we are pivoting our focus to the commercial launch preparations on strong data for our very successful phase III pivotal trial of <unk> bus a lot of talk from a per injection in the treatment of cervical dystonia following closely behind because of our clinical program for adult in the specificity which is.
Mark J. Foley: I don't know that we've got any sort of better data than that. You know, we're in the launch phase, so obviously, the accounts that we're dealing with represent sort of a smaller fraction of the overall market. Having said that, I would say that, you know, 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.
Preparing for phase III for these for these reasons, we're pleased to announce the appointment of Rob banks.
And the general manager of Therapeutics from added to the strength of our team, bringing more than 25 years of experience in healthcare and life Sciences.
He also has a strong background in the therapy of toxin space at Allergan relative instrumental for leading global pipeline of development strategies for both of our therapeutics laying the groundwork for expansion of investment like specificity migraine neurogenic overactive bladder gross.
Recently from the CEO of our commitment the company focus on accelerating solutions for brands.
Prior to that skews, the executive Vice President of health points out there.
Mark J. Foley: There's clearly, you know, some new consumers that are entering the market, partly due to the Zoom effect and everything else. And we feel very good that, at least for now, we've returned, at least for now, to levels that were pre-pandemic. And, you know, 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 see, with the roughly 2,000 or so accounts that we have between our products and services that were pretty targeted. But clearly, we're seeing a nice, healthy market right now.
With the strong background and track record, Rob will help strengthen our therapeutics pipeline strategy and advance our clinical development of bank of our franchise through commercialization.
Strong team of infrastructure in place, we look forward to elevate the value of our therapeutics franchise, the entering the growing to $3 billion of global Therapeutics Neuromodulator market.
I'll turn the call back over to Mark to discuss our upcoming pipeline milestones.
Barbara.
Thanks, Jonathan.
Participating to the key milestones that our therapeutics pipeline in the second half of the year.
<unk> mentioned, we are currently in phase III clinical trials evaluating talk to you about your line of products a day for injection for the treatment of cervical dystonia and the.
The second half, we expect to share the results of 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.
Seamus Christopher Fernandez: Great, and then just as a second question,
Youll recall that we completed our juniper phase II study in February of this year and our plan remains to hold at the end of phase II.
Seamus Christopher Fernandez: Very quickly on just, obviously you're expressing a high degree of confidence in the launch.
Seamus Christopher Fernandez: 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 of 2022. Or, you know, maybe just without guidance specifically, but just kind of the rollout through the balance of 2022. Thanks. Yeah, thanks for asking that. You know, first on the FDA process of where we're at.
Commercial activities for the taxi botulinum toxin 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 for $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 on.
R&D expenses include depreciation and amortization and stock based compensation.
Excluding these expenses non-GAAP R&D expenses were $24.9 million.
Mark J. Foley: FDA process and where we're at, you know, consisted of prior commentary; we indicated that prior to our producing a date, everything, you know, had been addressed except for the on-site inspection as part of our PAI, where we released a press release that an inspection date had not been scheduled yet, and then due to 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 was not a possibility, and they were going to need to physically inspect the plant.
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 cash equivalents and short term investments as of June 32021, or $336.3 million.
Which we believe the sufficient to fund our operating plan into 2024.
Further we reaffirmed our previously announced 2021 guidance.
Hi.
For 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.
Mark J. Foley: We then, in the spring, put out a press release that we had done. been given an inspection date to occur before the end of Q2. And obviously, in our press release and in our remarks on the FDA, has shown up at our facility. So we continue to feel very good that, you know, they're following sort of through with the expected inspection plan. Yes, I think, you know, you're sensing consistency with our tone around the expected approval before year end.
Thank you Tobey.
In closing, we're very proud of our performance for the first half of the year and anticipate a strong finish in the second half with the potential approval of the oxy botulinum toxin a for injection and further advancement in our therapeutics pipeline.
We also remain the solid financial position with sufficient cash to support our growth initiatives into 2020 for with that I'll now open the call up for questions operator.
Thank you as a reminder to ask a question you May Press Star then the number 1 on the telephone keypad Thats star 1 on the telesales.
Mark J. Foley: And we've taken advantage of this time to, you know, keep up sort of our readiness for the inspection and continue to, you know, advance our commercial preparation plans. In terms of the launch trajectory, you know, 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, excuse me, similar to what we did with the RHA filler line.
We will have our first question from the line of seamless Fernandez from Guggenheim. Your line is now open.
Alright, thanks very much so.
I'll do my 1 question and follow up.
Good day.
The kick off with the first question.
Abbvie really.
Under the al again.
Mark J. Foley: And so I think for the balance of, you know, this year and post-approval, we're going to spend most of our time focusing on ensuring that we get really good reproducible outcomes that are consistent with our clinical trial data and that, you know, her 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 step period post-approval where we are going to need to spend some time with a select group of customers getting real world commercial experience before going through a more traditional launch.
Monica.
Really delivered a very very strong second quarter. Congrats on your guys' second quarter, 1 thing that they commented on.
Was that they anticipate the debt approximately 2 thirds of the.
The demand was regular way demand the men about 1 third was pent up.
Would you guys, maybe just comment on your thoughts around.
That statement and.
So what it means relative to sort of the growth of the market relative to share taking.
Operator: Thank you. And now, the next question comes from the line of Terrence Flynn from Goldman Sachs. Your line is now open. Great.
As you think about it and then I'll just have 1 other follow up question.
Yeah.
Thank you for this this is mark I don't know that we've got any sort of better data than that.
Terence C. Flynn: Great, thanks for digging into the questions. Maybe just one follow-up mark on the Daxi manufacturing side. In the past, I think you've noted about a six to ten-week timeline 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've seen from the reorder side of things. Thank you.
We're in launch phase. So obviously the accounts that were dealing with represents sort of of 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 theres definitely a pretty healthy backlog on so we're talking with them. There is no doubt there is some pent up demand there is clearly some new.
Consumers that are entering the market somewhat of the zoom effect on everything else and 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 the accounts that you can tell with the.
Mark J. Foley: Just the first off, you know, we intentionally didn't get sort of a set time frame because we're outside of the Padoof o'clock, where within the Padoofa framework, you know, everything is moving towards a deadline. You know, it's hard to know exactly the timeframe 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 outstanding issues.
The roughly 2000 or so of accounts that were in between our products and services that were being pretty targeted.
Clearly, we're seeing a nice healthy market right now.
Great and then just as the the second question.
Very quickly on just obviously, you're expressing a high degree of confidence.
In the launch.
So I'm assuming that the FDA inspection is is going.
Swimmingly, maybe you could just give us the 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.
Mark J. Foley: And so, you know, we continue to stick to our commentary that, you know, we're focused on an approval, certainly before the end of 2021, and we have full preparation and build schedule going on in the interim. Regarding the filler and reorder rates, I think it's still a little early for us to make a lot of commentary around that. I know this is our third full quarter of launch, so we are still seeing the cycle of accounts coming online and figuring out where it fits in their practice.
For the balance.
Maybe just without guiding specifically, but just kind of the rollout through the balance of 2022.
Mark J. Foley: And then we also expect, you know, with the, you know, approval of our neuromodulator, that's going to introduce another new dynamic in there that, you know, may change a little bit the percent of the business and accounts willing to consider giving to us, which accounts might be willing to lean in that we're, you know, otherwise waiting until we have a full bag. So I think it's still a little bit early, certainly as we, you know, get visibility and have data that we think is more reflective.
Yeah. Thanks for asking that first on the FDA process of where we're at now consistent with prior commentary indicated that prior to or produce the day everything had been addressed except for the on site inspection as part of our AI.
<unk> press release and inspection they had not been scheduled yet and then just of the FDA delays, we were in a bit of a holding pattern waiting for that to occur given that this is the first drug approval remote inspection without a possibility in the we're going to need to physically inspect the plant than the spring put out a press release that we had been given an inspection day to occur before the end of.
Operator: Thank you. Our next question comes from the line of Annabel Sammy from Stifall. Your line is now open. Thanks for taking my question.
The Q2.
In our press release and in our remarks on the FAA 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 yes.
Annabel Eva Samimy: Just a little bit more on that
Annabel Eva Samimy: 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, you know, potential training and education, such as
Yes, I think youre assessing consistency with our tone around the expected approval before year end on Wednesday.
The advantage of this time to keep up sort of our readiness for the inspection and continue to <unk>.
Annabel Eva Samimy: as commercial work, contracting work, preliminary contracting,
Annabel Eva Samimy: preliminary negotiation. Is there any of that stuff that can happen ahead of time that could potentially happen?
Advance our commercial preparation plants in.
In terms of the launch trajectory. We've also tried to be consistent this will be the 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 intentional.
Annabel Eva Samimy: the process for the launch and not pull away too much of the energy from the filler
Annabel Eva Samimy: momentum that you're having.
And the first phase of our launch.
Annabel Eva Samimy: And then on the manufacturing side,
Excuse me similar to what we did with the <unk> filler line.
Annabel Eva Samimy: I realized that, you know, you said that this is a process.
So I think for the balance of.
This year likely in post approval, we're going to spend most of our on focusing on ensuring.
Annabel Eva Samimy: And so, you know, I imagine that means that there's
That we're going to get really good reproducible outcomes that are consistent with our clinical trial data and that you know for commercial launches of likely to be much more of of 2022 phenomenon. So that's how we're thinking about it but there will be the stub period post approval, where we are going to need to spend some time with a select group of customers paying for.
Annabel Eva Samimy: It's been 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 the second half, and that's about all you're going to say? Thanks.
Real world commercial experience before going through our more traditional watch.
Mark J. Foley: If that does 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 the second half, and that's about all you're going to say. Thanks. Yeah, 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 approvals. So when we talk about commercial prep, it's all around, you know, we continue to refine our pricing strategy and,
Great. Thanks for your question.
Thank you and now the next question comes from the line of Terence Flynn from Goldman Sachs. Your line is now open.
Great. Thanks for taking the questions maybe just 1 follow up mark on the deck the manufacturing side in the past I think you've noted about a 6 to 10 week timeline for.
For a turnaround from the agency just wondering if thats still your expectation.
And then obviously a strong quarter for the filler side.
Here, so and obviously breath contributed but just wondering what youre seeing from the reorder side of things. Thank you.
Mark J. Foley: at the customer level. So, you know, we're continuing to establish the prestige, revans of Threat, an 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 a lot of the launch preparation is internal activities, getting all our sales materials ready and everything to support that.
Okay.
Just the first half.
In terms of it didn't get sort of a set timeframe because were outside of the produce the clock.
Where within the for due for framework everything is moving towards the deadline, it's hard to know exactly the timeframe that the agency is going to work under as it relates to the inspection clearly are trying their best I think to resolve any of these outstanding issues and so we continue to stick to our commentary that we're focused on on approval certainly for the.
End of 2021 and have full preparation and build schedule going on in the interim.
Regarding that the filler and reorder rates I think it's still a little early for us to make.
A lot of commentary around of doses are our full quarter of launch. So we still are seeing the cycle of the accounts coming on line figuring out where it fits in their practice and then we also expect.
Mark J. Foley: So that's kind of more of what we're doing on the commercial prep side. You on the match to the match. 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 inspections had not been scheduled prior to the Fedufa, and then again putting out a press release that one had been scheduled to occur before the end of June.
With the approval of our neuromodulator that has kind of introduced another new dynamic in there that.
May change a little bit of sort of the percent of.
The business and accounts willing to consider giving to us which accounts might be willing to lean in net were otherwise waiting until we had to pull back. So I think it's still a little bit early as certainly as we get visibility on have data that we think is more reflective of what the business is going to look like going forward. We're happy to share for we still think we're a little bit early on that process.
Mark J. Foley: So I wouldn't read into my commentary about the process. This is sort of a standard piece that needs to happen before approval. So, you know, the next communication you'll hear from us is kind of once we get the FDA decision. But again, I come back to the fact that we feel very good about our preparation and where we are in that process, and we continue all of our preparation.
Great. Thanks next question.
Thank you all of our next question comes from the line of kind of Louis Chamois from Stifel. Your line is now open.
Hi, guys. Thanks for taking my question.
Just a little bit more on the commercial.
Operator: Thank you. Our next question comes from the line of David Amselam from Piper Sandler. Your line is now open.
Preparations for getting ahead of the approval on.
What are you able to day, obviously penetrated a decent amount of accounts is there anything that you can do outside of <unk>.
David A. Amsellem: Hey, thanks. So my first question is on the fillers. I don't know if you've talked about this in your prepared remarks. I'm sorry if I missed it, but can you just talk about the mix among the different SKUs? Are there any of them predominating, or are there any that have gained particular traction or that practices have a real affinity for thus far?
On the potential training and education, such as the commercial work contracting where preliminary contracting preliminary negotiation is there any of that stuff I can happen ahead of time that could potentially smoothed the process for the launch not pull away.
David A. Amsellem: I know it's still relatively early in commercial life in these early days, but, you know, if things evolve, what are you seeing out there in the field? So that's number one. And then number two, can you just remind us about Daxi: once you get approval, what sort of net are you going to cast in terms of training injectors? In other words, you know, how many should we expect you to have trained within the first six and, say, 12 months of the commercial life of Daxi? And over time, should we expect some Salesforce expansion, given that there are more injectors of neuromodulators than there are of fillage? So how should we think about that thing? Great, thanks, David.
Too much of the energy from the.
On the filler.
The momentum that you're having and then on the manufacturing side.
I realize that.
You said that this is the process and.
And so you know I imagine that means that there is a bit of of back and forth. If there are any issues that come on.
Would you be telegraphing any of that or is this just you're keeping it as part of the process and they're still on board for second half of that's about all you are in the same thanks.
Mark J. Foley: So the first one on the mix side of it, we didn't address that in our scripted comments, but previously, what we said last quarter was that it was roughly a third, a third, a third. We're not seeing a major shift between two, three, and four. We're still early.
Yes, the first on the commercial prep, obviously in the absence of approval, there's not much of what we can do from a promotional standpoint or anything until we have approval. So when we talk about commercial prep. It's all around you know we've continued to refine our pricing strategy and more market research work that we've been doing.
We've taken advantage of this of this gap between the launch of the filler.
Mark J. Foley: I think, you know, people are still figuring things out. And I've been surprised that, you know, when we've been out in the field, kind of the range of places that people are using it. Obviously, we're limited to focusing on indications on the glabella lines, but, you know, I think that we're finding folks use this for different performance characteristics. And you'll hear from one party that they like the performance characteristics of RHA2 and somebody else on RHA4. So right now, it's still pretty even.
And the expected approval of the neuromodulator to build.
Bill for the relationships with physicians at the customer level. So we're continuing to establish the prestige revamped the threat of aesthetics brand.
I think people see us now as a company that's working towards a broader range of products both from a services on a product stage.
And then obviously, we talked about building inventory in advance of launch so a lot of the launch prep is internal activities getting all of our sales materials ready and everything to support that so that's that's kind of more of what we're doing on the commercial prep side, you're on the master of manufacturing side, we kind of broke protocol and commenting on where we were in our SBA journey.
Mark J. Foley: I'm sure we'll see some separation over time, but right now, it continues to be pretty evenly split, the third of third and third. In terms of, you know, our neuromodulator and kind of how we're thinking about the launch in terms of, you know, this prestige and targeted strategy. And what we've talked about before is that, you know, out of the 30 to 40,000 injector accounts that we think there are in the U.S., a top third of those are really the targets that we're going after, and that, you know, we would expect over time to be in roughly half of that top third.
On the pandemic when we talked about the fact that of inspection had not been scheduled prior to the <unk>.
And then again, putting out a press release that 1 had been scheduled to occur before the end of June So I wouldn't read into my commentary about the process. This is sort of a standard the piece that needs to happen before approval.
So the next communication you will hear from US is kind of once we get the FDA decision, but again I come back to the fact that we fill.
Very good about our prep and where we were in that process and we continue all of our preparations.
And the in the hopeful approval of the crop.
Okay.
Okay.
Yeah.
Next question.
Thank you. Our next question comes from the line of David <unk> from Piper Sandler. Your line is now open.
Mark J. Foley: So, you know, right now we're in 2,000 accounts. Those are obviously going to be sort of our biased accounts to go after first because they lean 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 the number of accounts that we expect to target over time. I think that starts getting a little bit more towards guidance. But, you know, phase one is going to be making sure that as the product's used,
Hey, thanks.
First question is.
On the fillers.
I don't know if you've talked about this in your prepared remarks, I'm, sorry, if I'm if I missed it but can you just talk about.
The the mix.
On the the different Skus are there any of the dominating our of.
Are there any of that of gain particular traction or the practices of a real affinity for thus far I know.
It's still relatively early in the commercial life in these early days, but you know.
As things evolve what are you seeing out there on the field.
Operator: Thank you. Our next question comes from the line of Kim Lugo from William Blair. Your line is now open.
So that's the number 1.
Timothy Francis Lugo: Thanks for taking the question. And I know most people on the phone have probably heard this question over the past few years.
And then number 2 can you just remind us on on Dachsie once you get approval.
Timothy Francis Lugo: But ahead of, hopefully, an approval and launch of Daxi, I just wanted to revive 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 Daxin in the clinical trials and maybe some of the interest you're hearing from the field from RHA marketing. And just really an update on that thought of a long-duration asset versus a short-acting neurotoxigen in the excitement around the Yeah, so.
What's what sort of net are you going to cash in terms of.
On the training.
Training of the injectors in other words are you know.
How many should we expect you to have trained within the first 6 in say 12 months of the.
Of the commercial life of DAC C L.
And over time should we expect some sales force expansion.
Given that there are more injectors of neuromodulators than there are of <unk>.
Mark J. Foley: Yeah, as it relates to sort of, you know, the long duration profile that we've seen in clinical trials with our neuromodulator and sort of how that might fit into clinical practice, and the impact of a couple data points that will come out. There's a lot of market data out there that despite conventional neuromodulators lasting, you know, kind of three months, four months, average consumers only come in sort of 1.9 times a year or less. So, first and foremost, we think it figures in very well.
So how should we think about that thanks.
Great. Thanks, David So the first 1 on the mix side of it we didn't address those on our scripted comments. The previously what we said last quarter. We said it was roughly a third a third of third we're not seeing of major shifts between Q3 and for.
We're still early I think people are still figuring out and and I've been surprised of when we've been out of the field kind of the.
The range of places that that people are using it obviously, we're limited to focusing on indications on the glabella lines, but.
I think the refining of use this.
For the <unk>.
The performance characteristics and you'll hear from 1 party that they liked the performance characteristics of.
Mark J. Foley: to what the normal pattern is of consumers. Secondly, particularly with the prestige accounts that we're going after, when we've been out in the field, these folks, if anything, have long weeding lists. And so getting into these accounts is the challenge.
Of our G suite with somebody else on our 8-K for 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 pretty evenly split the third a third of third.
In terms of.
Mark J. Foley: And so if you're a provider, the only way that you can necessarily increase the services that you offer to your patients for increased profitability is if you can do more services at the same setting. And a neuromodulator treatment every, you know, twice a year fits really well with also providing filler as well. So this idea that you can add some sort of both filler and neurotoxins together to give better outcomes to patients and increase the per visit ticket makes a ton of sense.
Our neuromodulator and kind of how we're thinking about the launch in 6 to 12 months post launch.
We remain committed to the kind of the prestige and targeted strategy and what we've talked about before as debt.
Out of the kind of the 30 to 40000 injector accounts that we can do or are in the U S of top third of those are really the target that we're going after and that we would expect over time to be roughly half of that top third so right. Now. We're in 2000 accounts those are obviously going to be sort of on our bias accounts to go after first because.
The leaned in with our JV because of the prestige strategy. They like the idea of no pricing and so that's the 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 the target over time, I think that starts getting a little bit more towards guidance, but.
Mark J. Foley: So in the customers that we're talking to, and obviously we've got a bias towards those that are leaning towards the prestige strategy, it resonates a lot. The last thing I would say is, innovation for us underpins everything, but what that does also creates choice, creates more choice at the position level and at the consumer level. And so with that, the longer acting neuromodulator, we're not trying to be everything to everybody.
Phase 1 is going to be make sure that as the products use of <unk>.
Commercially that debt were building from a position of strength in terms of the outcomes and net after that we will sort of more broadly introduce it certainly to the prestige accounts that have already expressed an interest with us and.
Mark J. Foley: And so there are consumers in the practice that prefer coming in three, four times a year, and that's the cadence that they want, and the practice wants it. 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, you know, practice is being able to provide choice and figure out what fits 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.
And then there is no doubt that there will be a broader number of accounts that I think are going to have an interest of leaning in with us once the interim months later as a group.
Yeah.
Great. Thanks.
Alright. Thank you. Thank you.
Thank you. Our next question comes from the line of Tim Lugo from William Blair. Your line is now open.
Thanks for taking my question and I know most.
Most people on the phone have probably heard the question over the past year.
2 years.
It ahead of hopefully an approval on launch of debt.
I just wanted to revolve.
On the thoughts around physicians on how they want to see the patients more often the less often and agree with that view, but could you just refresh us with kind of what are you hearing from physicians, who have used that from the clinical trials.
Timothy Francis Lugo: That's great to hear. Thank you for clarifying.
Mark J. Foley: And maybe my one follow-up. In the therapeutic category, I just don't understand why a long-duration product would not be, or would not capture a majority of share eventually in an indication like cervical dystonia. Could, you 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.
And maybe some of the interest youre hearing from the field from our U K marketing.
Just really an update on that thought.
On a long duration versus the short acting neurotoxin in the kind of enrollment.
Okay.
Yes.
10 of it relates to sort of the long.
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 to the impacted couple of data points that will bring up the other there's a lot of market data out there that despite congressional neuromodulators lasting kind of 3 months for months debt average consumers only come in sort of 1.
Mark J. Foley: debilitating diseases and that, you know, the ability to reduce the frequency of visits obviously gives prolonged symptom relief, but it also takes some stress off of the system, right? It's, you know, less facility fee, physician time, and everything else. And so, you know, if you look at the data that we generated from our CD program, not only was the duration profile really strong, but we had a very encouraging safety signal as well with low dyspacia rates. And so, we really are optimistic about our neuromodulator performance in clinical trials and therapeutics. And so that's why we announced some of the new hires that we have, you know; we're starting to get ready for the commercial introduction of our, you know, cervical distone.
9 tenths of the airport last so first and foremost we think figures in very well for what the normal pattern of consumers secondly, particularly with the prestige accounts that we're going after when we've been out on the deal. These folks if anything have long waiting lists and so getting into these accounts is the challenge so Europe provider.
The only way that you can necessarily increase sort of the services that you offer to your patience for increased profitability and so if you can do more services in the same setting in a neuromodulator treatment every twice a year its really well with also providing pillar as well for this idea that you can add sort of both pillar of neurotoxins.
Together to give better outcomes for patients and increase the per visit ticket makes it part of SaaS. 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 of the last thing I would say is innovation for us underpins everything, but what that does all sorts of creates choice.
Operator: Thank you. Our next question comes from the line of Balaji Prasad from Barclays. Your line is now open. Again, your line is now open. Hi, good afternoon, everyone. Thanks for the questions. Apologies if this has been asked before, but I just want to go back to the number of accounts open this quarter, net accounts open, 2010.
Creates more choice of the physician level on at the consumer level and so with the longer acting neuromodulator, we're not trying to be everything to everybody and so there are consumers of the practice the prefer coming in 3 or 4 times of year end, that's the cadence that they want the practice of it.
Great, but based on our market research, we think theres, a not insignificant number of consumers that really will put a premium on a neuromodulator that lasts longer and so we think practices being able to provide choice figuring out what fits makes a lot of sense. So we continue to feel really good about the value proposition and how this is going to fit in the practices, but from a.
Balaji V. Prasad: Hi, good afternoon, everyone. Thanks for the questions. Apologies if this has been asked before, but I just want to go back to the number of accounts opened this quarter, net accounts open, 2000, 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 taxi launch.
Tumor demand and from a profitability standpoint.
That's great to hear thank you for clarifying and maybe my 1 follow up.
In the therapeutic category.
I understand why of long duration product would not the would not capture the majority of share of eventually and in.
In the case, Mike cervical dystonia.
Yes, I know Youre, obviously add into therapeutics.
Mark J. Foley: or so new accounts ads per quarter. Obviously, with some of the new products and programs that we have coming out, we'll need to sort of look to say, is account activation important, is doubling back 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 modulator, we will need to revisit that because, again, our strategy is much more versus deep versus wide.
Part of your franchise.
With the addition of but can you maybe talk to some of the market research.
Mind us about the micro research.
And the kind of to decline.
Sure and on I would say that's sort of aware of market research shows as well it actually shows that in the therapeutic area that we can become a share of leader I think it speaks to the fact that these are debilitating diseases and that the ability to reduce the <unk>.
Frequency of visits.
Obviously, it gets prolonged symptom relief, but it also takes some stress off of the system right. It's less facility fee physician time and everything else.
Mark J. Foley: We clearly have a lot of run room in the accounts that we view to be our target market market opportunity, but you know, with this tracking right now, it's not unreasonable to sort of look at, you know, 500 new accounts per quarter as, you know,
And so if you look at the data that we generated from our CD program not only with the duration profile of really strong of where we had a very encouraging safety signal as well with low dose safety of rates.
So we really are optimistic about the neuromodulator performance in clinical trials for therapeutics and so.
Mark J. Foley: Thanks, Mark, that's helpful. And maybe a quick one on bias in Botox to just see where you are post your resubmission or submission. Sorry, just with regard to the FDA data package that was submitted a couple months ago.
That's why we announced some of the new hires that we have starting to get ready for commercial introduction of our.
Cervical dystonia indication and the silver.
So very good about the performance profile of the product and the therapeutic market.
Operator: Thank you. Our next question comes from the line of Search Belanger from Needham and Company. Your line is now open.
Thank you for the question.
Thanks, Tim.
Thank you. Our next question comes from the line of <unk> Prasad from Barclays. Your line is now open.
Serge D. Belanger: Hey, good afternoon. Thanks for taking my question.
Serge D. Belanger: 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 correctly, patients
Good day and our next question comes from the line of from the Lucky for Seth. Your line is now open.
Hi, good afternoon, everyone. Thanks for the thanks for the question I apologize. If this is the main asked before but just wanted to go back to the number of accounts hope on this quarter 2000, and net accounts opened 2000 and try to extrapolate this as to what's likely to be the account opening run rate by the end of the year on how this.
Serge D. Belanger: 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 and safety. So in the open-label safety study, it was really a dose escalation study looking at, you know, the primary end point there was to look at the safety of, you know, sort of repeat doses over time, and so when
So your eventual index a launch.
Thanks.
Yes, so thanks a lot.
Serge D. Belanger: So the open-label safety study was really a dose escalation study looking at, you know, the primary end point there was to look at the state.
We've reported for the scope of our combined accounts between our services platform and our products, which start of chase product line at the end of each quarter. So we talked about there being over 500 at the end of Q3 over 1000 at the end of Q4 or 500 at the end of Q1 and now over 2000 at the end of Q2, so we've been averaging.
Serge D. Belanger: And secondly, with the addition of Rob Bancroft to the therapeutics team, should we look at that as a kind of confirmation that you're moving forward with commercialization?
Mark J. Foley: commercialization effort for the muscle movement disorder, and you're part of a commercial partnership Yeah, that's correct. In addition to Rob, we also announced last quarter the addition of, you know, another senior-level person on the healthcare reimbursement side of it, so we're focusing on that as well. And so, you know, we've long talked about our focus on building out, you know, sort of a direct sales force in the muscle movement space. And, you know, these are some of the key pieces that we're putting in place to allow us to access and enter that market.
<unk> 500, or so of new accounts as per quarter.
Obviously with some of the new products of programs that we have coming out of all need to sort of look to say his account activation is important is selling for actually making sure that with some of these new services that we're going deeper in the existing accounts, but I think those of reasonable numbers for now I think post approval of our neuromodulator, we'll need to revisit that because again our strategy is much more.
Versus the deep versus wide, we clearly have a lot of run room in the accounts that we view to be our target market opportunity, but can we did with this tracking right now it's not unreasonable to sort of look at 500, new accounts as per quarter as something that could continue to exist for the balance of the year.
Operator: Thank you. Our next question comes from the line of Ken Kassiatori from Calvin. Your line is now open.
Thanks, Mark that's helpful and maybe a quick 1 on.
But from the both of the just the var both gere.
Ken Cassiatori: How are you doing, team? Congratulations, just a really great performance without yet having a backseat.
For a submission of submission.
Sorry. This is the thing on to the FDA data the data data package for somebody does the cups.
Ken Cassiatori: So as we think forward, I know Mark, you want to be thoughtful in terms of how the product is rolled out, the experience, and 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 market, position 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?
For months ago.
So on the Biosimilar of what we indicated was that the next step of 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 the outlet before year end.
I know that the interest has their own the 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 just to lay out sort of what that program is going to look like for you Greg.
Got it thanks, Mike.
Great. Thank you.
Okay.
Okay.
Thank you. Our next question comes from the line of search of a lower from Needham and company. Your line is now open.
Hey, good afternoon, thanks for taking my questions.
Ken Cassiatori: Is there any kind of nuances you can give us as you approach this market that maybe have been different in the past that we're going to try to do a little bit differently in the future? Thanks so much. Thanks again.
The first 1 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 from the second half.
Mark J. Foley: 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 the number of folks that are actually doing toxic treatments. Our strategies are a little different, right? We're going after sort of the top of the pyramid on that side of it.
Recall patients are eligible to receive multiple courses of treatment. So maybe just give us the idea of what you'd be looking for in terms of.
Efficacy of duration and safety.
Just 1 on the open label safety study it would seem really of dose escalation study looking at primary endpoint there were still look at the safety of.
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 the different doses that occur over time and an increase in doses assessed 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 sort of.
Mark J. Foley: But I think, you know, all of these things happening in concert are no doubt going to help grow the overall market. So, you know, we would expect that they're going to continue to run their playbook, which is, you know, 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, you know, we will also drive more consumer awareness coming in, but ours is going to be much more focused again on these kinds of prestige and high-end practices.
We'll be reporting out on that.
Yeah.
Okay.
Secondly.
With the addition of the raw Bancroft for the.
<unk> therapeutics team.
We look at that as the.
Kind of a confirmation that youre moving forward with the commercialization.
The commercialization effort for the muscle movement disorders and the.
For the commercial partnership.
Yes, that's correct. In addition to Rob We also announced last quarter. The addition of.
And other senior level person on the health care reimbursement side of it so that we're focusing on that as well on.
<unk> talked about.
Our focus on building out.
Net of a direct sales force in the muscle movement of the space and these are some of the key pieces that we're putting in place to allow us to access and enter that market.
Mark J. Foley: So we don't expect a whole lot of difference 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, you know, you know, both of us will have kind of the playbooks that will run once we hit there. But from an overall approach to the market, I don't, I don't see any major differences from that standpoint.
As it relates to the cervical dystonia, we've talked about of filing in 'twenty, 2 and approval of <unk> 23, So it's not too far away and we believe that there is a fair bit of of opportunity to be unlock there.
Obviously, we think that the performance profile of our product will allow us the very competitive in the therapeutic category.
Yeah.
Thank you.
Yes.
Okay.
Thank you. Our next question comes from the line of Ken.
Operator: Thank you. As a reminder, to ask a question, you will need to press star, then the number one on your telephone. That's star one on your telephone. Our next question comes from the line of Vermil Devon from Mizuho. Your line is now open.
<unk> from Keybanc. Your line is now open.
How're you doing team congratulation, so just really great performance without yet having backseat so.
Vamil Devon: Great, thanks for taking the questions. So maybe just a couple from me. One on the PAYPAC integration that you've talked about for next quarter, can you maybe just provide a little more insight into the benefits you think that's going to provide for that side of your business?
As we think for it I know Marc do you want to be thoughtful in terms of how the product is rolled out the experience of the initial experienced 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 debt, maybe you all could occur.
Vamil Devon: and then the second part would just be maybe any update you might have around your efforts around migraines. You've talked about that being a matter of sort of
Or as you step back and look at the overall marketplace.
Vamil Devon: when you work on that as well, if you work on that, but just curious if there's anything new in that market. It's evolving pretty rapidly as well. So any new thoughts will be helpful. Thanks. Great, thanks, so first on the Payback side of it, you know, the real advantage of payback, in addition to participating in more of the overall margin stream of the credit card processing, the big advantage is that it gives us access to the store.
In terms of timing for you all on DTC and really differentiating this product as we think through maybe the the latter part of 2022 not necessarily the near term is there kind of any nuance 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 of the in the future. Thanks. So much.
Mark J. Foley: Great, thanks, so first on the Payback side of it, you know, the real advantage of payback, in addition to participating in more of the overall margin stream of the credit card processing, the big advantage is that 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 it access to the source level data. So things around data analytics and insights and even automating subscription services in a way that's, you know, seamless and easy to set up and white label loyalty become a lot harder if you don't have access to the source data.
Sure Thanks, Ken no.
Not really I mean, obviously as the market leader of they've talked a lot about sort of increasing DTC dollars, they've got a big push into the training new injectors, so theyre going to expand sort of the number of folks that are actually doing toxin treatments of our strategy for 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 we would expect that theyre going to continue to run their playbook, which is more awareness dollars.
Couponing, the customers' training of new injectors of all of which will help grow the market and as we come into the market with innovation we will.
Also drive for consumer awareness for 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 of the playbooks that we will run once we get there, but the from an overall approach to the market.
Mark J. Foley: So by becoming a payment facilitator, we are then able to scrape that source data, which again will be the practices' information, but then we can turn around and use that to help them with data, insight, and analytics. And so that's really the key functional functionality piece that's going to come into play. So we're very encouraged with how the beta launch of that is going and how it's performing. And again, that will be sort of the foundation that we will build out these other services on top of.
I don't see any major differences from that standpoint.
Thanks, so much.
Okay.
Thank you and the reminder to ask a question you will need to press Star then the number 1 on the telephone the star 1 on your telephone.
Our next question comes from the line of the meal demand from Mizuho. Your line is now open.
Great. Thanks for taking the question. So maybe just a couple from me 1 on the pay back on integration that you've talked about for next quarter can you, maybe just kind of little more insight and for the benefit do you think that can provide.
Mark J. Foley: And again, it will allow us the ability to participate in a little bit more margin spread, you know, if we choose to, you know, hold on to that or, you know, if we choose to give it back to the practices. On the migraine side of it, you know, to your point, we talked about it, sort of not as 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.
Kind of on that side of your business and then the second part would just be maybe any of you might have.
Around your efforts around the migraine and then you've talked about that being a matter of sort of.
When you work on that as most of the if you're working on that but just curious if there's anything new as debt.
On this is evolving pretty rapidly as well so any new thoughts would be helpful.
Mark J. Foley: And so we'll be, I think, better prepared to address sort of where migraine fits into our overall therapeutic strategy and what priorities that we have ultimately for, you know, 2020 when we give a little bit more color on our 2020 operations.
<unk>.
For example, our first on the Paypal side of it you know the real advantage of payback. In addition to participating in more of the overall margin stream of the credit card processing, it's the big advantages. It gives us the access to the store level data. So right now that the hint MD system is a robust credit for.
Vamil Devon: Okay, all right, thank you.
Operator: Thank you. Our next question comes from the line of Dog Tiao from H.C. Wainwright: "Airline is now open."
Card processor, but it doesn't necessarily give us access to the source level of data. So things are on data analytics and insights and EBIT automating subscription.
Chris Shibutani: Hi Chris Dallis here on behalf of Doug Stow. Congratulations on the Quarter. So I was just a little bit interested in the prestige segment that you're targeting for Daxi. Now, a competitor of yours is heavily targeting the millennial demographic, and I was just wondering how much overlap there is between these two segments. Thanks.
Subscription services in a way that's.
Seamless and easy to set up on white label loyalty becomes a lot harder. If you don't have access to the source data sort of becoming a payment facilitator. We then are able to scrape that source data, which again that'll be the practices information, but then we can turn around and use that to help them with data insight and analytics and so that's that's really the key on.
Channel functionality piece, that's going to hand, the we're very encouraged with how the the debate of launch of that is going and how it's performing in the 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.
Mark J. Foley: Hey, Chris, I think we need to separate the segmentation around consumer and then separation around practice. So the perceived strategies around our focus are really on partnering with those practices that drive value to the experiences they provide their patients, as well as the outcomes they provide their patients. So those practices see all patient types. Those might be millennials and everything in between.
For that or if we choose to get them back to the practices.
On the migraine side of it to your point, we talked about it sort of non if an awareness 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 better prepared to address sort of where migraine fits into our overall therapeutics strategy and what priorities that we have ultimately.
Mark J. Foley: So our strategy is really different from the others in that we believe we can build the most of the most of the types of loyalty directly to those practices by providing that experience with us and great innovative products, and then the consumers that they treat to be loyal to the practice. So our loyalty really lies in driving it to those practices. So those practices will see all the millennials that will be coming into the space just as much as the others.
For 2022, when we give a little bit more color on our 2020 cooperating.
Okay alright, thank you.
Okay. Thanks, Paul.
Thank you. Our next question comes from the line of Doug <unk> from H C. Wainwright. Your line is now open.
Hi, everyone Christiane share on for Doug So all congrats on the quarter.
So I was just a little bit interested in the.
The prestige segment that you're targeting.
Chris Shibutani: Awesome, that's very helpful. Thank you.
For taxi now of competitor of yours is the heavily targeting the millennial demographic and I was just wondering how much overlap there is between these 2 segments. Thanks.
Operator: Thank you. Again, as a reminder, to ask a question, you will need to press star, then the number one, on your telephone. That's star one on your telephone keypad. 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 this year, we expect to share the results from our Aspen, open label, long-term safety,
Hey, Chris This is no, but I think we need to separate the second based on around consumer and then separation around craft those of the prestige strategy around our focus is really on partnering with those practices that drive value for the experience they provide the patient as well as the outcome there.
So those practices see all patient types of those might be millennials and weighted all in between so our strategy is really different from the other 2 that we believe we can build the most amount of oilseeds directly for those practices by providing the experience with us and great innovative product and then the consumers that increase the loyalty of the Frac.
Our loans, we really liked the drive units to those products. So it was all of those practices.
Automobile sales coming in the space just a question on the other price.
Awesome, that's very helpful. Thank you.
Mark J. 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.
Excellent.
Thank you again.
Again as a reminder to ask a question of you will need to press Star then the number 1 on your telephone.
The star 1 on your telephone keypad.
Yeah.
Okay.
We don't have any further questions I would now like to hand, the call back to Mark Foley.
Mark J. Foley: So in the second half, we expect, second half this year, we expect to share the results from our Aspen, open label, long-term safety study. Afterward, we plan on filing a supplemental biologic license application in 2022, with approval expected in 2023. And again, that's for our cervical dystoning program. And our clinical team is also preparing for a phase three program in adult upper limb spasticity. You'll recall that we completed our Juniper Phase 2 study in February this year, and our plan remains to hold an end of phase two meeting with the FDA before year end.
Thank you operator before I make my closing comments I just wanted to recap some of our third of our therapeutics 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 the supplemental biologics license application in 2022 with anticipated 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 data for phase III study in February of this year and on <unk>.
<unk> remains the hold an end of phase II meeting with the FDA before year end.
Mark J. Foley: So to close things out, in the coming months, we plan to virtually attend this city's 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 would like to thank all of you for participating in today's call. Thanks.
So at the close things out in the coming months, we plan to virtually turned the Citi and Wells Fargo Health care conferences. We welcome your request for meeting for these events are directly through us feel free to reach out the Jessica if you'd like to schedule some time with the.
I would like to thank all of you for participating in today's call.
Okay.
Ladies and gentlemen, this concludes today's conference call. Thank you for participating. Goodbye. You may now disconnect.
Ladies and gentlemen, this concludes today's conference call. Thank you for participating you may now disconnect.