Revance Therapeutics Inc (RVNC) 2021 Q3 法說會逐字稿

Welcome to Revance Therapeutics Third Quarter 2021 Financial Results and Corporate Update Conference Call.

(Operator Instructions) As a reminder, this call is being recorded today, 9th of November 2021.

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

Please go ahead.

Thank you, Laurie.

Joining us on the call today from Revance, our Chief Executive Officer, Mark Foley; President, Dustin Sjuts; Chief Financial Officer, Toby Schilke; and Senior Vice President of Clinical Development, Roman Rubio.

During this conference call, management will make forward-looking statements, including statements related to the potential approval and timing of approval of DaxibotulinumtoxinA for Injection in glabellar lines and therapeutic indications; our ability to remediate deficiencies identified by the FDA regarding our BLA; a Type A meeting with the FDA; financial performance, revenue and processing volume run rate; financial performance and guidance; expected cash runway; our strategic priorities and cash preservation plans; our market and revenue opportunity and market demand for our products and services; the safety, efficacy and duration of DaxibotulinumtoxinA for Injection; the potential commercial success and worth of our products and services; the potential benefits of our drug product candidates and technologies; the clinical development of our product candidates; our business strategy; planned operations; commercialization plans; and the aesthetics and therapeutics industries.

These forward-looking statements are based on the company's current expectations and inherently involve significant risks and uncertainties.

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

Also on today's call, we will present both GAAP and non-GAAP financial measures.

A reconciliation of non-GAAP to GAAP measures is included in our earnings release.

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

Mark?

Thank you, Jessica.

Good afternoon, everyone, and thanks for joining our third quarter 2021 financial results conference call.

Before we cover our performance for the third quarter and review the positive results from our Phase III ASPEN-OLS study for cervical dystonia, I'd like to provide an update on our BLA for DaxibotulinumtoxinA for Injection in glabellar lines.

As most of you are aware, we received a CRL from the FDA on October 15, citing their inability to approve our application in its present form due to deficiencies related to the on-site inspection of our manufacturing facility.

We're obviously very disappointed by the FDA's response and also understand that the continued delay of our BLA has been frustrating for all of our stakeholders.

However, I can assure you that the entire Revance team is as determined as ever to get our neuromodulator product approved as soon as possible.

We are currently working on preparing the briefing book for a Type A meeting request to gain clarity and alignment on the requirements needed for approval and are incorporating the additional information that was provided by the FDA following our CRL, including our Establishment Inspection Report, to inform our submission.

Given where we are in this process and our pending engagement with the agency, it is inappropriate for us to comment beyond what we've already communicated until we have our Type A meeting.

We look forward to providing an update once we have confirmation on our pathway to approval.

This is not the first time we've experienced a launch delay.

Recall that last year, the commercial rollout of RHA was pushed back 5 months due to COVID-induced supply chain constraints from our partner, TEOXANE SA.

Despite the delay and working under the limited parameters of the pandemic, we safely onboarded over 100 sales reps, trained injectors and delivered a very successful launch that generated $58 million in its first 12 months and a revenue run rate of over $70 million as of Q3 2021.

Looking back, I'm proud of the tremendous progress we've made as an organization over the past 2 years.

First and foremost, in aesthetics, we submitted our BLA for our lead product, DaxibotulinumtoxinA for Injection for glabellar lines.

We also successfully completed the Phase II program for our drug product in upper facial lines, secured the exclusive distribution rights for TEOXANE's RHA line of fillers in the U.S., acquired HintMD and launched OPUL and built out a strong commercial infrastructure.

In therapeutics, we validated the opportunity for our long-acting neuromodulator in treating muscle movement disorders with the successful completion of our Phase III program in the treatment of cervical dystonia and our Phase II clinical trial for upper limb spasticity.

Collectively, the muscle movement disorder market opportunity currently stands at $1.2 billion worldwide, and about 78% of that opportunity is in the U.S. The completion of our ASPEN program for DaxibotulinumtoxinA for Injection in cervical dystonia arms the company's second successfully executed Phase III program supporting the differentiated performance profile of our neuromodulator across our [clinical] trials in aesthetics and therapeutics.

All of these milestones position us to create meaningful value within our aesthetics and therapeutics franchises.

To put it simply, the opportunity for a long-acting neuromodulator remains strong and continues to be an unmet need for patients and consumers.

We continue to believe in the approvability of our product, and based on the CRL, the deficiencies cited were limited to observations made during the agency's on-site inspection of our manufacturing facility.

In other words, the CRL is not related to our clinical data package or our product anticipated label.

That said, I'd like to outline our strategic priorities going forward while also announcing some related organizational changes.

Our number one strategic priority is to obtain FDA approval for DaxibotulinumtoxinA for Injection for glabellar lines as soon as possible.

Number two is to continue to increase our revenue in the $1.2 billion U.S. dermal filler market with our RHA Collection.

And number three is to expand and cultivate deep and lasting customer relationships through OPUL, our fintech platform.

In addition to aligning our capital allocation strategy with these priorities, we will also be preserving cash to enhance our financial flexibility.

Dustin and Toby will cover more on the specifics of our priorities later in the call.

In line with our strategic initiatives and in order to optimize our structure for performance, I'm pleased to announce the promotion of Dustin Sjuts, our Chief Commercial Officer, to President of Revance.

This change allows me to streamline my reports as I assume direct and personal oversight for all aspects of our BLA for DaxibotulinumtoxinA for Injection.

Further, this change positions the organization to better align resources, facilitate capital allocation efforts and enhance performance.

Dustin's promotion to President reflects the strong performance and the confidence we have in his leadership.

He was instrumental in developing Revance's commercial strategy, integrating HintMD, building an exceptional team and successfully commercializing our aesthetics portfolio.

His experience and background will continue to be invaluable to our organization.

With that, let me turn the call over to Dustin who will cover our performance for the quarter.

Dustin?

Thank you, Mark.

First, let me say -- by saying I'm honored to serve as President of Revance.

To echo Mark's comments, we've come a long way over the past 2 years in laying the foundation for growth.

And none of that would have been possible without our team.

In my years overseeing commercial operations, interfacing with the departments across the organization, I continue to believe that we have the right vision, strategy and people in place to realize our potential across both aesthetics and therapeutics.

The market demand for long-lasting neuromodulator remains robust, and this is supported by recent clinical programs initiated by our peers to attempt to show extended durations with higher doses of their existing neuromodulator formulations.

Our formulation is new and uniquely different from what's available on the market today.

It's the only neuromodulator product with a proprietary peptide formulation with clinical data demonstrating a long duration profile in addition to safety and efficacy.

In our SAKURA studies, a 40-unit dose of DaxibotulinumtoxinA for Injection showed a median duration of effect of 6 months and up to 9 months for certain patients.

Further, our strong clinical data for aesthetic indications in glabellar lines, forehead lines, lateral canthal lines and upper facial lines as well as therapeutic indications in cervical dystonia and upper limb spasticity have all consistently demonstrated a long duration profile.

For these reasons, we believe DaxibotulinumtoxinA for Injection is the most differentiated potential neuromodulator formulation to date.

Turning to our results.

Total RHA revenue for the third quarter was $18.3 million, a 7.4% increase over Q2 despite a slower period.

Growth was driven by higher sales from existing accounts as well as the addition of new accounts.

During the quarter, we added over 500 accounts across RHA and our fintech platform, bringing our total aesthetic accounts to over 2,500.

Looking ahead and given the continued strength in the overall market, we expect a seasonally strong Q4 heading into the holiday season.

Since its commercial launch 1 year ago, the RHA Collection is proving to be a valuable and differentiated product line.

It's the most natural and least modified hyaluronic acid dermal filler on the market today, and we're pleased with the traction we have built thus far.

Our commercial team is focused on expanding the prestige customer base for RHA, which in turn will serve directly as the commercial foundation for DaxibotulinumtoxinA for Injection once approved.

We believe that we can realize significant cross-selling opportunities and operating leverage with our aesthetic franchise over time.

OPUL, the first Relational Commerce platform for the aesthetics vertical, adds another exciting piece to our portfolio.

We have long believed that the best way to retain and attract customers is to be their true partner to help them build a better practice and stronger consumer loyalty.

[It equips us] to develop a fintech platform that can not only complement our product offering but also support practice growth.

OPUL leverages data from its transactions to help owners build a better relationship with their customers.

It's a first-of-its-kind technology platform that we believe has the ability to transform patient and physician experiences.

In addition to helping us create deep and lasting customer relationships, OPUL provides us with the opportunity to participate in the $68 billion U.S. aesthetics payment processing market.

And now as a registered payback, the platform can capture more of the credit card processing value chain.

Over time, we believe this can represent a substantial revenue opportunity north of $500 million.

During the third quarter, we maintained a payment processing volume run rate of over $0.5 billion despite a traditionally slower season.

Looking ahead, we believe OPUL has a significant runway for growth.

We'll be very focused on account penetration, building new features and completing customer migration in HintMD through OPUL.

Turning to therapeutics.

I'd like to share the positive top line results from our Phase III ASPEN-OLS study for cervical dystonia.

As a reminder, our Phase III program consists of 2 trials: the ASPEN-1 and the ASPEN-OLS or open-label safety study.

ASPEN-1 was a pivotal study evaluating the efficacy of DaxibotulinumtoxinA for Injection for the treatment of cervical dystonia and was successfully completed in October of 2020.

ASPEN-OLS was an open-label, multicenter trial to evaluate the long-term safety of repeat treatment of DaxibotulinumtoxinA for Injections in adults with cervical dystonia.

The study enrolled a total of 357 subjects, of which approximately 90% rolled over from the ASPEN-1 study.

Subjects could receive up to 4 treatments over a 52-week period, and the doses evaluated included 125, 200, 250 and 300 units.

We are pleased to report that the study demonstrated DaxibotulinumtoxinA for Injection was found to be generally safe and well tolerated as well as effective across all doses with repeat treatment.

The most common treatment-related adverse events on a per treatment basis were muscular weakness at 4.9%.

dysphagia at 4.2% and injection site pain at 2.7%.

There were no serious treatment-related adverse events or dose-dependent increases in adverse events.

We are pleased to see that the efficacy data in ASPEN-OLS is consistent with the efficacy results and duration profile observed in the ASPEN-1 study.

In the ASPEN-OLS  study, the median duration of effect, as defined by the time to reach target TWSTRS score, ranged from 19.9 weeks to 26 weeks across doses within the evaluable treatment cycles.

Comparatively, median duration of effect observed in ASPEN-1 study was 20 to 24 weeks for 250 units and 125 units.

Given the safety, efficacy and long duration profile, we continue to believe that DaxibotulinumtoxinA for Injection can be promising -- can be a promising new treatment option for adults with this condition.

In particular, we believe the compelling dose-ranging data from the study can help physicians optimize treatment plans for patients, especially since the dosing strategy and treatment effect can vary with each patient.

ASPEN-3 clinical program is our second successfully completed Phase III program with DaxibotulinumtoxinA for Injection across 2 different treatment categories.

We'll assess the best way to advance our opportunity in cervical dystonia and upper limb spasticity following clarity from the FDA on the approval path of our BLA for glabellar lines.

With that, I'll turn the call over to Toby to cover our third quarter financials.

Thanks, Dustin.

Total revenue was $19.7 million for the third quarter, which included $18.3 million from our RHA Collection, $1.1 million from our partnership with Viatris on the biosimilar to BOTOX and $0.3 million from our fintech platform.

Turning to our operating expenses.

Selling, general and administrative expenses for the third quarter were $52.8 million.

This primarily included sales and marketing expenses related to RHA and pre-commercial activities for DaxibotulinumtoxinA for Injection.

SG&A expenses included depreciation, amortization and stock-based compensation.

Excluding these expenses, non-GAAP SG&A expenses were $45.1 million.

Research and development expenses were $30.1 million for the third quarter, reflecting costs related to clinical trials, regulatory support for our ongoing BLA, pre-commercial manufacturing and quality activities and fintech platform development.

R&D expenses included depreciation and amortization and stock-based compensation.

Excluding these expenses, non-GAAP R&D expenses were $25.7 million.

Cash, cash equivalents and short-term investments as of September 30, 2021, were $273.7 million.

Revance's shares of common stock outstanding as of October 28, 2021, were approximately 71.8 million, with 76.8 million fully diluted shares excluding the impact of convertible debt.

Now I'd like to review our capital allocation priorities and the prudent measures we are taking to extend our cash runway.

As Mark and Dustin mentioned, our investments at this time are focused on obtaining FDA approval for DaxibotulinumtoxinA for Injection, driving greater adoption of RHA and expanding and deepening our customer relationships through OPUL.

We believe this will maintain our strong commercial momentum and enhance our financial flexibility.

The proactive steps we are taking to preserve cash include but are not limited to pausing noncritical hires, deferring a Phase III clinical program for upper limb spasticity as well as other therapeutic pipeline activities and pausing international regulatory and commercial investments for DaxibotulinumtoxinA for Injection with the exception of our collaboration with Fosun in China.

Due to the CRL we received from the FDA, we are withdrawing our previously stated cash guidance of cash into 2024, which assumed FDA approval of DaxibotulinumtoxinA for Injection in 2021.

Following our Type A meeting with the agency and upon gaining clarity for -- on our approval pathway, we plan to provide an updated cash guidance and our 2022 GAAP and non-GAAP operating expense guidance.

I'd like to emphasize that while our measures to preserve cash are important, we also expect them to be temporary.

We remain committed to building our business long term and particularly our therapeutics franchise given the strong clinical data we have accumulated, underscoring the differentiated performance profile of DaxibotulinumtoxinA for Injection.

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

Thank you, Toby.

In closing, we executed on our commercial strategy and delivered a strong Q3 in our base business despite the impact of seasonality.

We're also very pleased to advance our therapeutics potential to treat cervical dystonia with the completion of our Phase III ASPEN clinical program, representing a market opportunity north of $300 million in the U.S. In the near term, obtaining FDA approval is our top priority.

As we speak, we are preparing a briefing book for the Type A meeting request, and we'll provide an update once we have confirmation on our path forward.

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

Operator?

(Operator Instructions) And our first question is from Ken Cacciatore of Cowen and Company.

Mark and team, a question around the CRL.

I know when you received it, there was a little bit of lack of clarity into all the different things that were being asked for.

I know you now indicated you have the Establishment Inspection Report.

So wondering if that provided you any more clarity.

Does it provide any more comfort or discomfort after you've now seen that?

And then secondly, can you just talk about the folks that you've been working with, both internally and externally, consulting with you that have expertise here?

Have you changed that at all?

Are there folks you've brought in?

Or is it the same folks, and you feel fairly comfortable with who's helping you navigate through the process?

Thanks, Ken.

So first, on the CRL, as we mentioned at the time that we received the CRL, there was no clarity exactly on which of our responses to the 483 were going to be sufficient or not sufficient.

And we indicated at that time that prior to requesting a Type A meeting, we're hoping to gain additional clarity from the agency before filing the Type A meeting request.

Subsequently, as we commented on in our prepared remarks that we have received the EIR and additional feedback from the agency, which is going to guide sort of the submission of the Type A meeting request.

We continue to feel really good about the responses that we provided to the 483.

This will allow us to target more of those responses.

At this point, we're not going to get into sort of surmising anything.

We're getting into sort of a play-by-play with the agency.

We do feel like the Type A meeting is the point where we plan to get more clarity from the agency, and we'll provide more context and color at that time.

On the consultant side of it, we feel, first off, really good with the responses that we provided to the 483.

We were, frankly, surprised that we didn't have any communication from the agency along that journey.

And so receiving the CRL in response to our 483 responses was disappointing and surprising.

Given that, however, in the sort of the importance of getting our product on market as soon as possible, we certainly continue to leverage the external experts that we've used along this entire BLA journey and have sought out additional experts and advisers along the way to make sure that we are getting the benefit of the latest information and the best information that's out there.

And so again, this is #1 priority.

We're looking at sort of all different avenues to try and get our product onto the market as soon as possible.

And again, with this additional information, it's allowed us to refine our Type A meeting request.

And our next question is from David Amsellem of Piper Sandler.

So just a couple on the CRL and the path forward here.

So the FDA action was essentially delayed for almost a year due to pandemic-related constraints.

So I wanted to ask you, to the extent that you can answer this, assuming the agency is going to go -- have to go back into the facility and do an inspection, is the pandemic in any way a factor into your calculation regarding turnaround time?

And how should we think about that?

And maybe do you have any sort of feedback from the FDA as to what their constraints are right now since that has been a consideration in the past?

So that's number one.

And then number two is, with these kind of processes with consultants, internal consultants, external consultants, et cetera, do you have a sense of what kind of spend you might need or additional spend, if you will, to get to a point where you have all your ducks in a row in terms of manufacturing?

And maybe you don't know the answer to that, maybe that's post-Type A meeting, but can you just help us understand just at least qualitatively what your thoughts are there?

Sure.

So first, David, on your question around the CRL and the path forward and any impact from the pandemic, again, I -- and listen, I get sort of the desire for clarity, and even internally, we're trying to make sure that we're being as transparent as we can.

I think given where we are, what we want to make sure is that when we do communicate, we communicate with certainty and clarity.

And so right now, we'd be speculating further as to whether or not there will be pandemic-related issues in terms of timing.

Again, we believe that the best way to get clarity on this is through a Type A meeting.

Obviously, the sooner we can get that clarity, the better.

And once we get that, I think we'll be able to lay out with a lot more certainty exactly what the path forward is going to be and what it's going to take.

On the consultant side of it, in terms of spend and manufacturing and everything else, we talked earlier about sort of the priorities that we've laid out to getting approval.

It's delivering on the RHA revenue and continuing to drive adoption of the OPUL platform while being judicious with our spend.

And so we believe we've got the right plan in place, and we'll resource all of those appropriately to make sure that we continue to not lose momentum and deliver on those key priorities for the company.

And our next question is from Seamus Fernandez of Guggenheim.

So just a couple of quick ones.

I'll move beyond the CRL, but wanted to just get a sense of how the trajectory for the RHA fillers you feel is likely to continue into the fourth quarter and into next year.

It sounds like there's high conviction that, that continued growth will be there.

But it was our understanding that DAXI was also sort of a forward use opportunity for some of your key positions.

So is the goal next year to really broaden out the RHA account number substantially beyond sort of the 2,500?

Or is it really to increase the penetration of the existing practices?

I know that -- I'm sure you're going to increase penetration of the existing practices as part of the standard.

But the question is, does the pullback on spend limit your ability to expand to new accounts in any way, shape or form?

And I have a second question after that.

Sure.

So maybe I'll jump in and maybe let Dustin add a little context and color as well.

So first off, in terms of the trajectory, let me start by saying we're incredibly pleased with how well the RHA launch has gone.

I mean in a short period of time, we've validated the strategy.

We generated really good revenue growth.

And I think it's a testament to the strategy and the execution of our commercial team that's out there and the quality of the RHA product line.

We're also still looking forward to getting RHA 1 approved, which we also think will help going forward.

So a couple of macro things.

The overall market dynamics continue to be really healthy.

So consumer is engaging in facial injectables.

That continues to be a really robust market.

We think Q4 seasonally tends to be stronger than Q3.

So that's all good.

And then if you look at sort of the headwinds and the tailwinds, on the tailwinds side of it, you've got ongoing focus on the RHA product lines, which would have competed for a little bit of time with the launch of our neuromodulator.

So we'll continue to drive that.

As you mentioned, Seamus, the number of accounts, we've talked about sort of going after the prestige category in the market, which is the top third, which is roughly 15,000 or so, which we said we'd kind of get into roughly half of those.

So we're kind of 2,500 along that journey, adding roughly 500 accounts per quarter.

So we do think that there's still room to drive ongoing penetration there.

Countering that a little bit is obviously, we know that having a neuromodulator in our bag will also help unlock opportunity in some accounts.

So again, tailwinds, we've got focus, we've got new accounts that we can open.

And then headwinds, I think, partnering it with the neuromodulator, but we are heading into sort of a strong season.

And I don't know, Dustin, if you want to add anything to that.

Just a couple of things.

I think the strategy for Rev Aesthetics focused on the account and not on driving consumers' loyalty kind of beyond the agnostic of an account has really resonated.

That resonates well with RHA and we get some lift on that.

I will address the spend question as well.

We feel very confident that as we laid out those strategic priorities, we're able to make adjustments in resources to ensure that we're not choking the spend on the RHA line and investing in those things that have the highest return.

So very good growing markets in dermal fillers, and we think that we'll continue to be able to drive growth.

While it'd be great to have DAXI right now, we feel like we can utilize this time to focus on RHA.

And the demand for DAXI is there.

I get countless calls for -- from doctors already asking when it's coming, when it's coming, as you can imagine.

So we feel like we could use that momentum around the Revance aesthetics strategy with OPUL and RHA to get us started and grow both new accounts as well as our penetration.

Great.

And then just in terms of the planned filing for CD that I think we were anticipating this year, how should we think about the CRL, the manufacturing discussion points and when you'll be able to provide us with a detailed update on the overall sort of filing strategy in 2023?

Will that come alongside the Type -- the post-Type A meeting updates?

Or will that come perhaps at a later point in time?

Yes, Seamus.

So just to reset, sort of what we communicated on CD was to complete sort of the OLS program in '21, file in '22, approvals in '23.

And now that we've completed the overall Phase III program, we are certainly in a position to be able to file that.

Our strategy all along was to file this as a BLA supplement to the glabellar lines approval.

We continue to think that that's the most prudent strategy and approach.

However, given the linkage between the sBLA filing and the approval of our glabellar lines indication, I think the most appropriate time to give an update on that will again be after the Type A meeting, we will have more clarity and visibility.

Great.

And then just one final question.

Any visibility on the actual timing or kind of the regulatory timing of the Type A meeting itself?

It was our understanding that it would be -- probably take 2 weeks to request and then 30 days post that to actually get the meeting, but we're hearing about some delays at FDA, a lot of backlog.

Just wanted to see if there was any sort of general clarity on that, that you might be able to provide.

Just even the outside possibility that this could be kind of an end-of-Q1 meeting is something that we're getting questions from investors on.

Sure.

Yes, I'll go back to kind of Ken's earlier question.

Again, what we'd indicated previously when we received the CRL, given that there wasn't any specifics in the CRL itself, we were hoping to get a little bit more clarity, which we now have, to sort of refine the meeting request binder that we put together.

So we think we've got that clarity to guide that filing.

And then we know what the statutory time lines are.

Typically, it's 14 days for them to sort of review and make a decision on granting a Type A meeting or not.

And then that gets scheduled within 30 days.

Certainly with the pandemic, I'm sure there are scenarios where that could get pushed out.

We're hopeful that, that will stay on track and on target.

And again, our plan is to communicate with clarity once we've got the Type A meeting.

And our next question is from Annabel Samimy of Stifel.

This is Nick Rubino on for Annabel.

Congratulations, Dustin.

So you mentioned the double dosing regimens from competitors.

What have you seen in the marketplace in terms of trends towards practices utilizing this method?

And do you see the economics around this regimen potentially infringing on DAXI's value prop?

And then just a quick one.

Did the end-of-Phase II meeting change anything about how you're thinking about the JUNIPER study going forward?

I know it's kind of on the back burner for now, but just any thoughts around that meeting?

Sure.

So first on double dosing, if anything, I think we look at it as sort of further credentialing of the long-acting neuromodulator opportunity.

I think if you go back in time, there was sort of a long narrative that there really wasn't a need and patients didn't want it.

But I think pretty quickly now it's coming to a point where people recognize that there is a real need in the market, and I think that it's reassuring to see competitors starting to talk about the long-acting category.

However, these products have been on the market for over 30 years, and a lot of effort has been put into trying to characterize different dosing and different ways of evaluating performance.

So until there's a true Phase III data out there that looks at it, we continue to think that in the absence of a differentiated formulation, it's going to be hard to match the duration profile matched with the safety and efficacy of our product.

So we continue to feel like there's a huge opportunity on that.

You mentioned the economics.

Certainly, if you start getting into double dosing with conventional short-acting neuromodulators, you do start to bump up against sort of what's the affordability of that.

And as we've talked in the past, in terms of positioning, we think that there's an ability for us to get a premium and for customers to pay a premium and practices to make more margin.

But we think that the economics with our product will work, whereas with some of the higher dosing, I think that's a little bit of a TBD.

On the end-of-Phase II ULS program, we are very encouraged by the feedback that we received from the agency in that end-of-Phase II meeting.

So we now have clarity around the Phase III program that will be needed to move that forward and to ultimately seek approval for that indication.

As Toby mentioned in his remarks, given sort of the need to prioritize the approval of the BLA, the ongoing sort of adoption of the RHA line of filler products and getting OPUL out into the marketplace, we're going to pause sort of the Phase III program.

But again, this is not an if.

It's a when.

And we will look to sort of resume activities around our therapeutics pipeline once we feel that we're in a position to do so.

But again, very good end-of-Phase II meeting with the agency, and we feel, again, we've got the clarity that we were looking for on our Phase III program there.

Great.

And just a quick clarification, are you seeing it -- the double dosing, as far as actually being used in the market, are you seeing trends of that increasing?

Like are more people doing that now versus before?

Or is it more just -- it's generating clinical buzz as opposed to commercial use?

This is Dustin.

We actually haven't seen it really resonating.

These are clinical trials.

A lot of these have been IITs and obviously other Phase IVs.

So the rigor of those is not necessarily the same as a Phase III program with stringent end points.

I think it's a novel concept that people are trying to do as it relates to kind of data generation, but practicality is, I don't believe any manufacturers cut their price in half.

If they haven't done that, the value for the practitioners to try to do that for a slightly increased duration profile is one that doesn't seem to resonate.

And also, there's never really been long-term safety on increasing the neuromodulator dosing to try to drive that efficacy.

So to date, no, we have not seen that resonate outside of a few publications.

And our next question is from Vamil Divan of Mizuho.

So maybe one around DAXI.

And just in terms of the EIR, can you give any clarity around that specifically?

Was it specified as a Voluntary Action Indicated or Official Action Indicated or anything sort of more in terms of what you saw there?

And then maybe just a couple of sort of quick kind of clarifications from -- I guess, for Toby.

Just as you sort of think about your cash position and some of the changes you're making, can you just talk about how that impacts the Viatris collaboration in terms of spend there?

And then just in terms of sort of SG&A, R&D, sort of I don't know if you can provide any sort of run rate that we should think about for fourth quarter or maybe for the first couple of quarters of next year as we update our models just in terms of kind of how that might be impacted by these efforts you're making.

Vamil, this is Mark.

I'll take the first one and then let Toby take your second question.

So in terms of more clarity on the EIR, again, I completely understand the desire for more information.

But we -- yes, I think actually, we feel really good about the responses that we provided to the observations in the 483.

We believe that we've got the additional information that we need to refine our Type A meeting request, and we're not going to be commenting on additional specifics until we get the Type A meeting with the agency to make sure that, again, we've got full clarity on what's going to be needed going forward.

Toby?

And then with regards to the question around Viatris, again, we continue to believe in that collaboration and that partnership that we have.

We had a successful Type 2 meeting that provided clarity on what's needed to conduct a successful clinical trial for the biosimilar to BOTOX.

So we will continue to invest alongside Viatris.

Recall that, that R&D collaborations is a 50-50 cost share going forward.

Then your third question was on the mix of fourth quarter spend and sort of projected run rates going forward for OpEx.

I think there will be a little bit of puts and takes as we approach fourth quarter on sort of where we are for the full year just given that there will still be -- we had anticipated a little bit more capitalization of sort of the manufacturing costs for the inventory reduction of DAXI.

However, that will be offset by less SG&A on sort of the launch and the [peri] launch for DAXI if that makes sense.

And then the cash preservation initiatives that we already have underway to extend our cash runway, I'll just guide you to our Form 10-Q that we filed today where we assessed that operating plan that we described in the prepared remarks against sort of our current financial resources.

And in there, we concluded we had sufficient balance sheet resources to fund our operations for at least 12 months filing the Form 10-Q.

(Operator Instructions) And we have a question from Tim Lugo of William Blair.

Now that you've had RHA out there for a year, and I know we're all hoping for a relatively quick resolution at the agency around DAXI, but how are you game-planning 2022 if DAXI is not on the market for the whole year?

And how should The Street kind of expect to see RHA and, I guess, also OPUL sequentially grow throughout the next few quarters?

Or is it to the extent of we're just waiting for DAXI and that halo effect that will come when DAXI is approved?

Yes, Tim.

So first off, on RHA, again, we -- if you look at our commercial infrastructure and the people that we have in place, the strategy, the dollars that were supporting that brand, we feel like we continue to drive adoption independent of DAXI.

And if you look at sort of the success that we've had to date and the commentary we made earlier about the fact that we're still largely -- or pretty thinly penetrated into our target market, the fact that our team is very focused on it, the fact that we expect RHA 1 to come online here, we continue to like how we're positioned in the market and the ability to continue to drive penetration.

And the same with OPUL, too, we just recently integrated the payback functionality in there, which will start to allow us to turn on additional features.

And so we continue to think that both of these can stand on their own.

It's obviously premature to speculate sort of what that runway looks like independent of our neuromodulator.

And that's why I think once we have clarity from the agency around the Type A, we'll be in a better position to sort of talk about what the ramp and the specific growth runway looks like.

I don't know, Dustin, if you want to add anything on that.

I think we feel really good.

The market is continuing to grow.

We've been purposeful about building a standing value proposition for the unique characteristics of RHA.

You didn't see us coming out with pricing programs, coupons and others that are artificially driving demand based off of price.

People are choosing to buy RHA because the technology is different than what they have in their practices today.

And our strategy for Rev Aesthetics is different than what they're getting from other manufacturers.

That doesn't change without DAXI.

Of course, we want DAXI, and we look forward to having it as quickly as possible.

We feel very good about the strength of RHA and OPUL agnostic to DAXI.

That's great to hear.

And is there any update with your partnership with TEOXANE?

I know that they took stock in the deal, and obviously, the stock has been extremely weak since the CRL.

Is there -- what kind of -- I guess what's the general status of the relationship?

And is there -- are there any kind of triggers around share price that could be -- that could impact the relationship?

Yes, Tim.

No, the upfront sort of stock grant that we made was part of the overall distribution deal that we had, which was a 10-year deal in the U.S. with the ability to extend it for 2 1-year periods up to a total of 12.

There are minimums in there around sort of revenue and spend.

But they've been a great partner.

We continue to feel really good about how we're performing in the marketplace.

So if anything, given the delay in our neuromodulator, we're able to focus more resources and focus on building the brand, which over time we think will benefit us in terms of a larger account base once we ultimately get our neuromodulator approved.

But now the relationship continues to be really strong, and there's nothing related to the equity from a relationship perspective.

And there are no further questions at this time.

I will now turn the call over back to Mark Foley, Chief Executive Officer, for his closing remarks.

Thank you, operator.

In the coming months, we plan to virtually attend the Stifel and Piper Sandler health care conferences.

We welcome your requests for meetings at these events or 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.

And this concludes today's conference call.

Thank you for participating.

You may now disconnect.

Goodbye.