Q4 2021 Revance Therapeutics Inc Earnings Call
Operator: Welcome to the Revance Therapeutics' fourth quarter and four-year 2021 financial results and corporate update conference call. All participants are in a listen only mode.
Welcome to the revenge therapeutics fourth quarter and full year 2021 financial results and corporate update conference call. At this time all participants are in a listen only mode. Following management's prepared remarks, we will hold a Q&A session to ensure that we have ample time address everyones.
During the Q&A session.
Ask for a limit of one question and one follow up question per person.
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Mind you. This call is being recorded today Monday February 28, 2022 ill now like to turn the call conference call over to Jessica Sarah head of Investor Relations and ESG for revenge. Please go ahead.
Jessica Serra: Thank you, Victor. Joining us today on the call from Revance are Chief Executive Officer Mark Foley, President Dustin Sjuts, and Chief Financial Officer Toby Schilke. During this conference call, management will make forward-looking statements, including statements related to the regulatory process and potential approval and timing of approval for doxybotulinum toxidase for injection and globular lines, as well as in therapeutic indications, plans related to the RRJC collection and OPAL platform, our financial performance, processing volume runway, 2022 guidance, expected cash runway, strategic priorities and capital allocation plans, our market and revenue opportunity, and the market demand for our products and services, and our business strategy, planned operations, and commercialization plans.
Thank you Victor joining us today on the call.
Chief Executive Officer, Mark Foley President.
And Chief Financial Officer, Toby Schilke gentlemen.
During this conference call management will make forward looking statements, including statements related to the regulatory potential.
Potential approval timing.
That's a bunch of laptops for injection.
Well listen therapeutic indications and it's related to Archie collection form our financial performance.
On May 22 filings expected cash flow should.
Strategic priorities of capital allocation, our market and revenue opportunity on the market demand for our products and services and our business strategy and operations.
Okay.
Jessica Serra: These forward-looking statements are based on the company's current expectations and inherently involve significant risks and assertions. 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.
These forward looking statements are based on the company's current expectations and inherently involve significant risks.
Our actual results and the timing of events could differ materially from those anticipated.
And such forward looking statements as a result.
Yeah.
Also on today's call, we will present, both GAAP and non-GAAP financial measures.
Conciliation of non-GAAP to GAAP measures is included in our earnings release with.
With that I will turn the call over to Mark Foley Chief Executive Officer.
Mark.
Mark Foley: Thank you for joining our fourth quarter employee or 2021 financial results conference call. 2021 marked Revance's first full commercial year, and we could not be more pleased with our execution, ending the year with over $72 million across our products and services. These results were led by RHA Collection, the latest advancement in hyaluronic acid dermal filler technology that continues to gain share in the large and growing U.S. filler market. We now have over 3,000 accounts across our Dermal Filler and FinTech platform, which generated over half a billion dollars in gross payment volume for the year.
Thank you Jessica good afternoon, everyone. Thank you for joining our fourth quarter and full year 2021 financial results Conference call.
21, Mark Revamps his first full commercial year, and we cannot be more pleased with our execution ending the year with over $72 million across our products and services.
These results were led by our <unk> collection, the latest advancement in the hyaluronic acid dermal filler technology continues to gain share in the large and growing U S solar market.
We now have over 3000 accounts in the U S across our dermal filler in Fintech platform, which generated over half a billion dollars in gross payment volume for the year.
Our focus on innovation and our customers will continue to be core to our ability to scale in the years ahead.
Mark Foley: Our focus on innovation and our customers will continue to be core to our ability to scale in the years ahead. Going into 2021, we have five key strategic priorities. [inaudible] Obtaining FDA approval for daxubotulinum toxin A for injection for the treatment of co-pillar lines following the deferred action of our PDUCA date in November of 2020. Strong Commercial Execution [inaudible] Advancement of our Therapeutics Franchise. Discipline Capital Allocation and the focus on our people, culture, and diversity and inclusion.
Coming into 2021, we have five key strategic priorities, obtaining FDA approval productive botulinum toxin nave for injection for the treatment of <unk> lines. Following the deferred action of our <unk> date in November of 2020.
Strong commercial execution.
Management of our therapeutics franchise.
Disciplined capital allocation.
And our focus on our people culture and diversity and inclusion.
Mark Foley: We'd like to take a moment to review how we are tracking on these priorities, as well as provide some recent updates. First, while we did not receive FDA approval for our neuromodulator product, as we had anticipated, we made meaningful progress in advancing our regulatory path. Earlier today, we announced that we have successfully manufactured three consecutive drug substance lots and one drug product lot as required by the FDA for the qualification of our new working cell bank. Completion of the manufacturing activities paves the way for the resubmission of our BLA for Daxiboxylinotoxin A for injection for glabellar lines as soon as possible.
I would like to take a moment to review how we track how these priorities as well as provide some recent updates.
First while we did not receive FDA approval for our neuromodulator product as we had anticipated we made meaningful progress in advancing our regulatory path.
Earlier today, we announced that we have successfully manufactured three consecutive drug substance lots and one drug product bought as required by the FDA for the qualification of our new working cell banks are.
The completion of the manufacturing activities paves the way for the Resubmission of our BLA Pradaxa botulinum toxin APRA injection.
Well the other lines as soon as possible.
Mark Foley: You'll recall that based on our Taipei meeting with the agency in December, a complete response to address the outstanding observations related to one, the qualification of our new working cell bank in two, our drug substance manufacturing process required us to qualify our new working cell bank by producing three consecutive drug substance lots and one drug product lot. This qualification process was already underway at the time we announced our type A meeting results, and we are very pleased to have completed the qualification activities in a timely manner.
Call that based on our type a meeting with the agency in December .
Fleet response to address the outstanding observations related to one the qualification of our new working cell banks into our drug substance manufacturing process required us to qualify our new working cell banks by producing three consecutive drug substance lots and one drug product law.
It's a qualification process was already underway at the time, we announced our type a meeting results and we are very pleased to have completed the qualification activities in a timely manner.
Mark Foley: We are now working on a resubmission package and will provide an update once we have resubmitted our BLA. As we have indicated previously, and based on our Type A meeting, a reinspection of our manufacturing facility will be necessary once a resubmission is accepted by the agency. Furthermore, based on FDA regulations, once the resubmission is accepted, the agency has up to six months to complete its re-inspection of our facility, along with the review of our resubmitted VLA.
We're now working on our Resubmission package and will provide an update once we have resubmitted our BLA.
As we've indicated previously and based on our type a meeting a re inspection of our manufacturing facility will be necessary. Once our resubmission is accepted by the agency.
Other based on the FDA regulations once the Resubmission has accepted the agency has up to six months to complete its reinspection of our facility along with a review of our resubmitted BLA.
Mark Foley: We remain focused on getting our neuromodulator product approved as soon as possible and look forward to engaging with the agency to facilitate this process. As I have already addressed our commercial execution in my opening remarks, I will now turn to our third strategic priority for 2021, the advancement of our therapeutics franchise. In 2021, we successfully completed both our Aspen Phase 3 clinical program for cervical dystonia and our Phase 2 clinical program for adult upper limb spasticity.
We remain focused on getting our neuroma modulator product approved as soon as possible and look forward to engaging with the agency to facilitate this process.
As I already addressed our commercial execution in my opening remarks, I will now turn to our third strategic priority for 2021, the advancements of our therapeutics franchise.
In 2021 and was successfully completed both our Aspen phase III clinical program for cervical dystonia, and our phase III clinical program for adult upper limb spasticity.
Mark Foley: The completion of our Cervical Dystonia Clinical Program marked the second successfully completed Phase III program for doxybotulinum toxin A for injection, demonstrating that the drug was generally safe and well-tolerated with an extended duration profile across both therapeutic and aesthetic indications.
The completion of our cervical dystonia clinical program Mark the second successfully completed phase III program for Doxy botulinum toxin aimed for injection demonstrating that the drug was generally safe and well tolerated with an extended duration profile across both therapeutic and aesthetic indications.
Mark Foley: For our Dolce Buckerlin's Baptist indication, we completed the Phase II Clinical Program and also held a productive end-of-phase II meeting with the FDA, which informed the requirements for a Phase III Program for this indication. Given our progress, we are poised to file a supplemental BLA for cervical dystonia following the approval of Daxibotulinum toxin A for injection in clovellar lines. For our adult upper limb spasticity program, given some of the cash conservation measures that we implemented last year due to the delayed approval of our neuromodulator, we have paused the commencement of that pay three program and will continue to evaluate proper timing for its initiation.
For our adult upper limb spasticity indication, we completed the phase II clinical program and also held a productive end of phase II meeting with the FDA, which informed the requirements for our phase III program or the syndication.
Given our progress we are poised to file a supplemental BLA in cervical dystonia following the approval Doxy botulinum toxin eight for injection in both our lives.
For our adult upper limb spasticity program, given some of the cash conservation measures that we've implemented late last year due to the delayed approval of our neuromodulator, we have paused the commencement of that phase III program and we'll continue to evaluate the proper timing for its initiation.
Mark Foley: Turning to Capitol Allocation, we have been disciplined in evaluating and pursuing opportunities that will generate the highest return for our stockholders. To that end, we have been prudent in our efforts to balance growth and cost throughout the year, particularly following our CRL to maximize our financial flexibility. His ongoing efforts to allow us to end the year with cash into 2023. Finally, in spite of the challenges presented by our remote and hybrid work policies due to the COVID-19 pandemic, we have worked hard to foster employee engagement while also creating a strong culture that embraces diversity and inclusion. He's a priority involved in programs and initiatives across all levels of the organization.
Turning to capital allocation, we have been disciplined in evaluating and pursuing opportunities that will generate the highest return for our stockholders.
To that end, we have been prudent in our efforts to balance growth and cost throughout the year, particularly following our CRM to maximize our financial flexibility.
These ongoing efforts have allowed us to end the year with cash into 2023.
Finally in spite of the challenges presented by our remote and hybrid work policies due to the COVID-19 pandemic. We have worked hard to foster employee engagement, while also creating strong culture that embraces diversity and inclusion.
These priorities involve programs and initiatives across all levels of the organization.
Mark Foley: Hubnote, we successfully met our corporate diversity and inclusion goal for the year, expanding across talent acquisition and internal educational and leadership forum. Before I turn the call over to Dustin to walk us through our fourth quarter operational achievements, I would like to review our strategic priorities for 2022. First, our primary goal remains gaining FDA approval for doxybotulinum toxin A for injection in globular lines as soon as possible.
Of note, we successfully met our corporate diversity and inclusion both for the year spanning across talent acquisition and internal educational leadership forums.
Before I turn the call over to Dustin to walk through our fourth quarter operational achievements I would like to review our strategic priorities for 2022.
First our primary goal remains gaining FDA approval for doxey botulinum toxin APRA injection.
Obama lines as soon as possible, we're actively working on a resubmission, which will bring us one step closer to that goal.
Mark Foley: We're actively working on a resubmission, which will bring us one step closer to that goal. Our second priority is to continue to drive top-line growth through our products and services, which will continue to be anchored by the RHA collection of dermal fillers in 2022. Third, we plan to drive the execution of our Opal Relational Commerce Platform now that we have completed the Payback Migration and are able to expand the platform's functionality. We will continue to focus on disciplined capital allocation to drive long-term value for our stockholders.
Our second priority is to continue to drive topline growth for our products and services, which will continue to be anchored by the Orange a collection of dermal fillers in 2022.
Third we plan to drive deeper penetration of our Opal relational commerce platform now that we have completed the payback migration and are able to expand the platform functionality.
Fourth we will continue to focus on disciplined capital allocation to drive long term value for our stockholders.
Mark Foley: Fifth, and finally, we will continue to invest in our people and our culture, upon which our success is built. I'm thankful for all the efforts and dedication of the Revance organization in 2021, and I look forward to our shared success in 2022. With that, let me turn the call over to Dustin, who will cover our performance in the fourth quarter.
Fifth and finally, we will continue to invest in our people and our culture on which our success is built.
I'm thankful for all the efforts and dedication of the Readouts organization in 2021, and I look forward to our shared success in 2022.
With that let me turn the call over to Dustin who will cover our performance in the fourth quarter.
Dustin Sjuts: Thank you, Mark. Let me start by echoing your appreciation to everyone in the organization for all the hard work and progress we've made during the year across both aesthetics and therapeutics. In 2021, we capped off our first full year of commercialization, a record of over $70.8 million in total RHA. These results were driven by RHA's innovative technology and the strong execution across our Revance aesthetic strategy, which continues to differentiate Revance from other competitors.
Yes.
Thank you Mark let me start by echoing your appreciation to everyone in the organization all the hard work and progress we've made during the year across both aesthetics and therapeutics in 2021 capped off our first full year of commercialization our reporting over $78 million in total RJ. So these.
Results were driven by our innovative technology and a strong execution across our revamped aesthetics strategy, which continues to differentiate romance from other competitors.
Dustin Sjuts: In the fourth quarter, RHA sales totaled $23.8 million dollars, representing an increase of 138% over our first long quarter, supported by new account growth, increased account productivity, and the impact of traditional seasonality. The second and fourth quarters are typically the strongest periods for aesthetic procedures each calendar year.
In the fourth quarter RJ sales totaled $23 8 million representing.
Representing an increase of 138% over our first launch quarter supported by new account growth increased account productivity and the impact of traditional seasonality.
The second and fourth quarters are typically the strongest periods for certain procedures each calendar year.
Dustin Sjuts: We're excited to build on RHA's momentum in 2022, particularly as we leverage cross-selling opportunities in our products and services and as we introduce RHA Redensity to our collection. You will recall, at the end of 2021, our partner, Chioxane S.A., received FDA approval for RHA rodentic, which was previously referred to as RHA-1. The approved indication for the treatment of moderate to severe dynamic periolitis or lip lines further augments the versatility of the RHA collection, providing injectors with a wider range of treatment options.
We're excited to build on our momentum in 2022, particularly as we leverage cross selling opportunities and our products and services.
And as we introduced our <unk> density to our collection.
You'll recall at the end of 2021, our partner <unk> SA received FDA approval for RH APRA density, which was previously referred to as our IHA one the.
The approved indication for the treatment of moderate to severe dynamic carryall writers or lift lines further augment the versatility of the IHA collection, providing injectors that the wider range of treatment options.
Dustin Sjuts: The product was well received by investigators in clinical trials, and we look forward to its launch in the second half of the year. The RIT collection now includes four distinct formulations that are dynamic, natural, and adaptable. We are currently working with Teoxin to bring new filler innovations to the market that will enable us to continue to fulfill the unmet needs of both injectors and consumers. Turning to our FinTech platform, an important highlight of 2021 was the launch of Opal. Opal is designed to help aesthetic practices optimize operations while enhancing consumer relationships.
Product was well received by investigators in clinical trials and we look forward to launching our density in the second half of the year.
Arctic collection now includes four distinct formulations that are dynamic natural and adaptable.
We're currently working with <unk> to bring new innovations to the market that will enable us to continue to fulfill the unmet needs of both injectors and consumers.
Turning to our Fintech platform, an important highlight of 2021 with the launch of <unk>.
It was designed to help a static practices optimize operations, while enhancing consumer relationships.
Dustin Sjuts: It's the first-of-its-kind relational commerce platform for the aesthetics industry. Initial launch features include seamless payments, practice reporting and analytics, and customizable checkout options containing a catalog of over 6,000 SKUs. We are currently developing new features to enhance adoption and retention. The team is leveraging practice insights to develop membership programs that will be meaningful to both practices and consumers.
It's the first of its kind relational commerce platform for the aesthetics industry.
Initial launch features include seamless payments practice reporting and analytics and customizable checkout options containing a catalog of over 6000 skus.
We are currently developing new features to enhance adoption and retention.
The team is leveraging practice insights developed membership programs that will be meaningful to both practices and consumers.
Dustin Sjuts: We began 2021 with a payment processing run rate of over $200 million, and through increased account penetration, we're able to nearly triple that run rate to almost $600 million at year end. As we previously indicated, payment processing volume is a key performance indicator for our FinTech product. Going forward, we'll be providing our gross payment volume for GPV, defined as a total dollar amount of all transactions processed in the period to our opal and his and D platforms, net of refunds.
Began 2021 with a payment processing run rate over $200 million.
Through increased account penetration, we're able to nearly triple that run rate to almost $600 million at year end.
As we previously indicated payment processing volume is a key performance indicator for a fintech platform.
Going forward, we will be providing our gross payment volume or <unk> defined as the total dollar amount of all transactions processed in the period through our Opal and <unk> platforms net of refunds.
For the full year 2021, or <unk> was $506 million in.
In 2022, our goal is to continue to grow our accounts develop new features and complete the migration of our legacy <unk> customers to Opel.
Toby Schilke: For the full year 2021, RGPV was $506 million. In 2022, our goal is to continue to grow our accounts, develop new features, and complete the migration of our legacy HintMD customers to Opal. With that, I will turn the call over to Toby to cover our fourth quarter and full year financials. Thank you, Dustin. We are pleased to report strong financial results for the fourth quarter and for the year. Revenue for the fourth quarter and full year 2021 was $26.0 million and $77.8 million, compared to $11.1 million and $15.3 million for the same period in 2020.
With that I'll turn the call over to Toby to cover our fourth quarter and full year financials.
Toby Schilke: Revenue growth on a quarterly and annual basis was driven primarily by increased sales of the RHA collection of dermal fillers. Revenue for the fourth quarter included $23.8 million of product revenue from the RHA collection of dermal fillers, $1.6 million of collaboration revenue from our partnership with VHS, and $0.5 million of service revenue from our FinTech class. For the year 2021, revenues included $70.8 million of our product revenue, $5.7 million of collaboration revenue, and $1.3 million from our fintech platform.
Thank you Dustin we're pleased to report strong financial results for the fourth quarter and for the year.
Revenue for the fourth quarter and full year 2021 was 26.0 million.
And $77 8 million.
<unk> to $11 1 million and $15 3 million for the same periods in 2020.
Revenue growth on a quarterly and annual basis was driven primarily by increased sales of the <unk> collection of dermal fillers revenue for the fourth quarter included $23 $8 million of product revenue from the RH, a collection of dermal fillers $1 $6 million of collaborate.
<unk> revenue from our partnership with DHS and <unk> $5 million of service revenue from our Fintech platform.
For the year 2021 revenues included $70 8 million.
Of our product revenue $5 $7 million of collaboration revenue and $1 $3 million from our Fintech platform.
Toby Schilke: Operating expenses for the fourth quarter and Foley Ear 2021 were $87.6 million and $352.5 million for the Foley Ear. Excluding depreciation and amortization and stock-based compensation, non gap operating expenses were $63.3 million for the fourth quarter and $265.8 million for the year.
Operating expenses for the fourth quarter and full year, 2021 were $87 $6 million and $352 $5 million for the full year excluding.
Excluding depreciation and amortization and stock based compensation.
non-GAAP operating expenses were.
$63 3 million for the fourth quarter and $265 8 million for the year.
Toby Schilke: As previously mentioned, our capital allocation at this time is focused on obtaining FDA approval for Daxibotulinum toxin A for injection. Driving top-line growth with our products and services, expanding and deepening our customer relationships through OVAL, and investing in our people and culture. We have also taken prudent steps to conserve and preserve cash by pausing non-critical hires, deferring a phase three clinical program for upper limb spasticity, as well as other therapeutic pipeline activities, and pausing international regulatory and commercial investment for daxibotulinum toxin A for injection, with the exception of our collaboration with Fosun in China. Due to these efforts, our GAAP and non-GAAP operating expenses for the year were below our previously announced guidance ranges.
As previously mentioned our capital allocation at this time it is focused on obtaining FDA approval for doxey botulinum toxin a for injection driving topline growth with our products and services, expanding and deepening our customer relationships and investing in our people and culture.
We have also taken prudent steps to conserve and preserve cash by pausing non critical 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 Dachsie botulinum toxin injection.
With the exception of our collaboration with Fosun in China.
Due to these efforts our GAAP and non-GAAP operating expenses for the year were below our previously announced guidance ranges.
Toby Schilke: Looking ahead, we expect 2022 GAAP operating expenses to be $375 million to $400 million, and our non-GAAP operating expenses, which exclude costs of revenue, depreciation, and amortization, and stock-based compensation, to be $260 to $280 million. Additionally, we expect non-GAAP research and development expenses to be $100 million to $110 million. R&D expenses in 2022 are primarily driven by manufacturing costs for Daxibotulinum toxin A per injection, which, according to GAAP accounting standards, are expensed as a period cost until the drug product is approved.
Looking ahead, we expect 2022, GAAP operating expenses to be $375 million to $400 million.
And our non-GAAP operating expenses, which exclude cost of revenue depreciation and amortization and stock based compensation to be $260 million to $280 million.
Further we expect non-GAAP research and development expense to be $100 million to $110 million.
R&D expenses in 2022 are primarily driven by manufacturing cost for doxey botulinum toxin a per injection, which according to GAAP accounting standards are expensed as a period cost until the drug product is approved.
Toby Schilke: Turning to our balance sheet, cash, cash equivalents, and short-term investments, as of December 31, 2021, were $225.1 million, which we believe is sufficient to fund our planned operations into 2023. Finally, revance the number of shares of common stock outstanding as of February 17, 2022 were approximately 71.5 million, with 78.2 million fully diluted shares, excluding the impact of convertible debt.
Turning to our balance sheet cash cash equivalents and short term investments as of December 31, 2021 for $225 $1 million, which we believe is sufficient to fund our planned operations into 2023.
Finally, <unk> shares of common stock outstanding as of February 17, 2022, or approximately $71 5 million with $78 2 million fully diluted shares excluding the impact of convertible debt.
Toby Schilke: And with that, I'll turn the call back over tomorrow. I'll turn the call back over tomorrow. Thank you, Toby.
With that I'll turn the call back over to Mark.
Mark Foley: In closing, we have a differentiated commercial strategy that is delivering the desired results but also allowing us to forge inroads into elite aesthetic practices that will provide us with a strong commercial foundation for a neuromodulator once approved. Our main priority for 2022 is obtaining FDA approval for doxybotulinum toxin A for injection into glabellar lines, which should not only accelerate our growth in aesthetics but will also pave the way for us to advance our therapeutics opportunities by filing a supplemental BLA for cervical dystonia.
Thank you Tony.
Closing, we have a differentiated commercial strategy that is delivering the desired results, while also allowing us to forge inroads into elite static practices that will provide us with a strong commercial foundation for our neuromodulator once approved.
Our main priority for 2022, it's obtaining FDA approval for doxey botulinum toxin nave for injection and global airline.
That should not only accelerate our growth in aesthetics.
Also paved the way for us to advance our therapeutics opportunity by filing a supplemental BLA for cervical dystonia.
I'd like to thank all of our stockholders for your continued support of Revamps I look forward to updating you on our progress in the new year.
Mark Foley: I'd like to thank all of our stockholders for your continued support of Revance. I look forward to updating you on our progress in the new year. With that, I will now open the call to questions. Operator.
I will now open the call up for questions operator.
Operator: As a reminder, to ask a question, you need to press star one on your telephone. And to withdraw your question, just press the pound. With our first question from Ken Cassiator from Cali, you may begin. Thanks so much.
As a reminder to ask a question you will need to press star one on your telephone.
And to withdraw your question press the pound key.
Our first question comes from the line of Ken.
I kind of see a tour from Cowen you may begin.
Mark Foley: Great to hear all the progress, guys. Mark, just wondering about the timing of the refiling; can you help us characterize that? Is it weeks? Or is it months? Can you can you put a little bit of a context around it would be great.
Thanks, so much.
To hear all the progress guys Mark just wondering on the timing of the re filing can you help us characterize that is it weeks or is it months can you can you put a little bit of context around that would be great. And then is there anything else from the 43 or are we just waiting here on the filing for the for the working cell banks.
<unk> of it thanks, so much.
Mark Foley: And then is there anything else from the 43? Or are we just waiting here on the filing for the working cell bank, the qualification of it? Thanks so much. Yeah, Ken, for the first one in the timing, we're not going to give specifics on it, but clearly, the long lead item was the qualification work related to the new working sell back. So at this point, it's a little bit more administrative in nature to just pull everything together.
Yes, I can so for the first one the timing, we're not going to give specifics on it but clearly the long lead item was the qualification work related to the new working cell banks. So at this point, it's a little bit more administrative in nature to just pull everything together and as we indicated we will definitely put out publicly.
<unk> then once we have refiled BLA. So obviously this is a.
High level of focus for us and again, it's more administrative in nature at this point.
Gardens to the 480 threes previously we said there were 540 threes and.
Our responses to the agency items three through five agency indicated our responses.
Appeared sufficient and then for items, one and two as we went into the type a meeting for it and that type a meeting coming out of that.
The what the FDA wanted to see was the qualification of the new working cell banks with three consecutive drug substance drug product that so.
That's what we've been working on providing.
The actual complete response, we will need to just sort of update the clinical.
Portion of our applications from a safety perspective.
And as it relates to the name just another name search on that but that's pretty much it.
Where that and we're working on those activities.
Hello.
Great. Thanks, so much.
Thanks.
Operator: Thanks. Our next question will come from Seanis Fernandez from Guggenheim. You may begin. Hey there, this is Alana on behalf of Seamus.
Our next question will come from the line.
Sean It's Fernandez from Guggenheim you may begin.
Operator: Thanks for taking our question and congratulations on a quick turnaround with the working cell bank. And so we just have a question regarding, you know, any potential range of options that you're considering for financing the company beyond 23. And in particular, any interest in a royalty transaction that would not only raise capital but validate the potential peak sales around Daxi. Any comment on that would be great. Thank you. Thanks Alana. This is Toby Schilke.
Hey, Dan this is.
I'm sorry, Seamus Thanks for taking my question and congrats on the quick turnaround with DIY consulting.
So we just have a question regarding any potential range of options that youre considering for financing the company beyond 'twenty three.
And in particular any interest in a royalty transaction that would not only raised capital, but validate the potential peak sales.
Any color on that would be great. Thank you.
Toby Schilke: You know, as we noted on the call, we have sufficient cash to fund our operations into 2023. Given our revenue profile and the late stage that we are with DAX, we have optionality. Obviously, you know, extending our cash runway is a key priority. And, you know, we'll take a thoughtful approach to a variety of financing strategies to balance where we are with our cash needs. While we can't comment on the specifics, we are taking this as a top priority. Awesome. Thank you.
Thanks, a lot of this is Toby schilke.
As we noted on the call we have sufficient cash to fund our operations into 2023, given our revenue profile in late stage that we are with <unk> vaccine we have optionality.
Obviously.
Extending our cash runway as a key priority.
And we'll take a thoughtful approach for a variety of financing strategies to balance where we are with our cash needs. So while we can't comment on the specifics we are taking this as a top priority.
Awesome. Thank you Matt.
Why.
Operator: Our next question comes from David Amsellem from Piper Sander. You may begin. Hey, thanks. So just a couple of questions on RHA. With your approval, I think that's the RHA-1 SKU.
Our next question I was I was wondering though David <unk> from Piper Sandler you may begin.
Hey, Thanks, So just a couple on alright.
With the approval I think that's the right one.
Operator: Can you talk about the extent to which that could provide an incremental bump in the sales trajectory or just talk about that opportunity in general? And then, secondly, just a broader question about the market here. Obviously, you had a good first year and the product's growing. I know you've said in Europe that the share is something like nine or 10%.
<unk> can you talk about the extent to which that could provide an incremental bump.
And the sales trajectory or just let's just talk about that.
Opportunity.
In General and then secondly, just a broader question about the market.
Here, obviously you had a good.
First year end.
And the products growing I know you've said in Europe your shares something like nine or 10% do you think that's where peak share could be in the United States do you think it could be higher how do you think about that in general thanks.
Mark Foley: Do you think that's where peak share could be in the United States? Do you think it could be higher? How do you think about that in general? Thanks. Thanks, David. I'll have, you know, Dustin answer the first part of that, and maybe I'll take Cracker a little bit on the back part of it.
Thanks, David I'll have Justin answer the first part of that and maybe I'll take a crack at a little bit in the back part of that sure. So yeah. Thanks, David So we're really excited about the approval of our Hai Route density, which you agree which you did mentioned was formerly called <unk> one.
Dustin Sjuts: Sure. So, yeah, thanks, David. So we're really excited about the approval of RHA Redensity, which you agreed, which you did mention was formerly called RHA-1, as the only approved filler for dynamic perioral rites or lip lines. You know, the perioral region is a bit challenging to treat because of the structure and the facial anatomy.
As the only approved filler for dynamic carryover items or lift one.
Dustin Sjuts: So we feel that RHA Redensity will give us a unique opportunity and add yet another tool in the toolbox for our injectors. RHA Redensity is built off of a technology that allows us to mimic the most natural HA that continues between RHA-2, 3, and 4 and RHA Redensity. So we look at this being a ninth edition, and it allows us to continue to kind of talk about our innovation profile. As it relates to volume, as you'll imagine, lip lines and small, more superficial areas aren't a high volume utilization of a filler, nor is it the first thing most people come in for.
The parallel region is a bit challenging a tree because of the structure and the facial anatomies. So we feel that our HCA where density will give us a unique opportunity and add yet another tool in the toolbox for our injectors are HLA is built off of a technology that allows us to be may make the most natural a J that continues between <unk> three.
And for <unk>. So we look at this being a nice addition.
It allows us to continue to kind of talk about our innovation profile as it relates to kind of volume as you imagine libert line and small more superficial area isn't a high volume utilization of a filler.
Nor is it the first thing most people come in for we feel like it's a nice icing on the cake that allows us to continue to kind of highlight the portfolio. So it's been a pillar space you see that we're constantly use this constant stream of innovation to keep being relevant trading new injectors allow us to continue to highlight that technology, so with that I'll talk.
Dustin Sjuts: We feel like it's a nice icing on the cake that allows us to continue to kind of highlight the portfolio. So within the filler space, you see that we'll constantly use this constant stream of innovation to keep being relevant, training new injectors, and allow us to continue to highlight that technology. So with that, I'll pass it over to Mark.
Over the past several months.
Mark Foley: Yeah, just I think, David, on your comments about market share, you know, what we've previously said that, you know, Deoxane in their top five EU markets had roughly a 10% share. You know, our share of the market right now depends a little bit on, you know, kind of what data you're looking at for the market. The last data we had was, you know, sort of 1.1 billion in the US.
David on your comments about market share what we previously said that.
The octane and their top five EU markets had roughly a 10% share.
Our share of the market right now depends a little bit on kind of what data youre looking at for the market. The last data we had was sort of.
$1 1 billion in the U S and so we're trending towards the high single digit penetration right now.
Mark Foley: And so, you know, we're trending towards a high single-digit penetration right now. The market continues to grow, so we've been encouraged by what we've seen there. We certainly don't feel that there are constraints in our opportunity in terms of, you know, penetration that is going to be limited to where Deoxane is in their top market, partly because there are, you know, fewer competitors in the US.
The market continues to grow so we've been encouraged by what we've seen there.
Certainly don't feel that there are constraints in our opportunity in terms of penetration that's going to be limited to wear shop tenants in their top market and partly because there is a.
Fewer competitors in the U S and we do think that once our neuromodulators approved that is going to allow us to compete certainly more effectively.
Mark Foley: And we do think that once our neuromodulators prove that they work, it's going to allow us to compete certainly more effectively from a bundling standpoint and meet all the needs of the injector. So we certainly are pleased with, you know, where we are from the start. And we do believe that once our neuromodulators prove that, it's going to give us additional opportunity to continue to drive deep earnings accounts. Okay, helpful. Thank you. (Inaudible) Thank you.
From a bundling standpoint, and meeting all the needs of the injector. So we certainly are pleased with where we are from a start and we do believe that once our neuromodulators approved that its going to give us additional opportunity to continue to drive deeper discounts.
Okay helpful. Thank you.
Thanks, David.
Operator: Our next question comes from Annabel Samimy from Stiefel. You may begin. Hi all.
Our next question comes from the line of Annabel Sammy sorry Annabel.
So Mimi from Stifel you may begin.
Operator: Thanks for taking my question. Congratulations on the progress. I suppose you're not commenting on the timing of the resubmission, but in the past, you've talked about hoping to get a launch before the end of the year and approval by the end of the year. Are you still planning on that if everything on the regulatory front goes according to plan following the resubmission? And then secondly, you know, Revance has been making quite an effort building up the aesthetics platform and working closely with practices with Opal and the FinTech platform. And it may be premature to ask this, but would any of these activities be precluded when you start adding therapeutic indications?
Hello.
Thanks for taking my question and congratulations on the progress.
I suppose you're not commenting on the timing of the resubmission, but in the past you've talked about hoping to get a launch before the end of beer and approval by the end of the year are you still <unk>.
And on that if everything on the regulatory front goes according to plan following resubmission.
And then secondly.
You know reverb system, making quite an effort building up the aesthetics platform.
And working closely with practices with football.
And the Fintech platform and maybe premature to ask this but what any of these activities be precluded.
When do you start.
Adding therapeutics indications.
Mark Foley: And have you given any further thoughts on whether aesthetics and therapeutics should be under the same umbrella? Thanks. Good questions there, Annabel. So, let me try and work through them.
Given any further thoughts, whether it's Fedex and therapeutics should be under the same umbrella.
Mark Foley: So on the launch timing, you know, we continue to be ready and prepared for launch when it happens. What we've said is that, following the resubmission, we would expect to get a new six-month BDUFA clock, given the agency's indication that a reinspection will be required. And given sort of where we are with the qualification for the cell bank, you know, we're certainly hopeful to, you know, get our application in as soon as possible.
Yes.
Two good questions. There Annabel so let me try and work through them. So on the launch timing.
We continue to be ready and prepared for launch.
When it happens.
<unk> said is that you will following the Resubmission, we would expect to get a new six months given the agency's indication that a re inspection will be required.
And given sort of where we are with the qualification of the cell bank were certainly helpful too.
Mark Foley: And sort of with a six-month clock after that, you know, 2022 is very much a priority for us in terms of, you know, getting DACSI approval. Shifting over to kind of the aesthetics, therapeutics, FinTech, once we move into therapeutics, does it in any way challenge our ability to continue to focus on the aesthetic initiatives that we've laid out? No, we don't believe so at all.
Get our application and as soon as possible.
With a <unk>.
Six months after that two.
2022 is very much a priority for us in terms of getting back to your approval.
Shifting over to kind of the aesthetics and therapeutics Fintech once we move into therapeutics does it in any way challenge our ability to continue to focus on aesthetic initiatives that we've laid out.
No. We don't believe so at all I mean.
The Fintech platform, we believe sort of stands on its own and is an important part of our products and services offering in the facial injectable category. The one thing that we've long talked about is that there will be price linkage between aesthetic and therapeutic but that that's the same with all the other competitors that are in that market.
Mark Foley: I mean, you know, the FinTech platform, we believe, sort of stands on its own and is an important part of our products and services offering in the facial injectable category. You know, the one thing that we've long talked about is that there will be price linkage between aesthetic and therapeutic. But, you know, that's the same with all the other competitors that are in that market.
Mark Foley: You know, we think there's a lot of value that we can unlock on the therapeutic side. And so, you know, we're going to continue to try and build a great aesthetic franchise. And that, you know, once we file our supplemental BLA for cervical dystonia, we'll start to build out that therapeutics franchise. And, of course, we're always going to be thoughtful about how we build the right shareholder value long-term.
We think theres a lot of value that we can unlock on the therapeutic side and so we're going to continue to try and build a great stat.
Franchise and once we file our feel our supplemental BLA for cervical dystonia, we'll start to build out that therapeutics franchise of course of course, we're always going to be thoughtful about how we build the right shareholder value long term.
Mark Foley: You know, today, we really like where we're positioned, and we think that the value proposition for a long-acting neuromodulator has never been better in terms of, you know, the opportunity, and I think the recognition in the competitive community that, you know, having a long-acting neuromodulator is going to be an important asset to have in the longer term.
Today, we really like where we're positioned and we think that the value proposition.
For a long acting neuromodulator.
It's never been better in terms of the opportunity and I think the recognition and the competitive community that happened a long acting neuromodulator is going to be an important asset to have longer term. So we will continue to evaluate that to see what we think makes the most sense, but right now we're very focused on kind of the plan as we've laid it out.
Okay, great. Thank you.
Mark Foley: So, we'll continue to evaluate that and see what we think makes the most sense. But, you know, right now, we're very focused on, you know, kind of the plan as we've laid it out. Great, thank you. Our next question will come from Elaina Balaji Prasad from Barclays. You may begin. Hi, good evening. Thanks for the questions. A couple of questions from me.
Our next question comes line of personnel from Barclays.
Again.
Operator: Firstly, on the supplemental DLA, can you help us understand what kind of timelines you would need to file it, assuming DAX is approved? Is it a question of a couple of months or longer? One. Two, also on the non-GAAP R&D that you guided us towards, the manufacturing costs being expensed, what kind of inventory is this for? Is it around six to nine months or more than a year?
Hi, good evening, thanks for the questions a couple of questions from me Firstly on the supplemental BLA can you help them. It doesn't stand what kind of timelines would you need to file it assuming vaccine approach is it a question of couple of months or longer.
One two also on the non-GAAP R&D that you that you guided towards the manufacturing costs being expense.
What kind of inventories. This fall is it around six to nine months or more than a year.
Mark Foley: And the linked question, what happens to the inventory in case the DLA filing gets further delayed? Hopefully, we won't get there, but in case it happens, what would happen to this inventory? Thanks. Yeah, this is Mark. I'll try and take maybe one and three and then hand it over to Toby for two.
And linked question what happens for the inventory in case, the BLA filing gets further delayed hopefully we don't reach them, but in case. It happens what were bell whatsapp into those inventory. Thanks.
Yes. This is mark I'll try and take maybe one and three and then hand it over to Toby for too.
Mark Foley: You know, the SPLA filing for cervical dystonia is teed up to be filed after we get approval for Vaxubotulinum toxin A for injection for glabellar lines. Given that we've already wrapped up that Phase 3 program, you know, we would expect to submit the application not too long after the approval of the glabellar lines indication. So, you know, we think that that is something that we can accomplish in a reasonable time frame, given, you know, sort of the time that we've had to prepare that application.
The <unk> filing for cervical dystonia is teed up to be filed after we get approval for vaccines extra botulinum toxin APRA injection for glabella lines, given that we've already wrapped up that phase III program.
We would expect to submit.
Not too long after the approval of the glabella lines indication. So we think that that is something that we can accomplish in a reasonable timeframe given sort of the time that we've had to prepare that that application.
Mark Foley: And then on the inventory that we've manufactured thus far, we've got a three-year dating on the product that we've manufactured. So, you know, we continue to feel like we're in a good position to be able to leverage and use that inventory. Obviously, it depends on timing.
And then on the.
The inventory that we manufactured thus far we've got.
Three year dating on the product that we manufacture. So we continue to feel like we're in a good position to be able to leverage and use that inventory.
Obviously, it depends on timing, but we've got a good amount of inventory with good data on it. So we feel we're in good position there Toby for number two perfect and just to expand on Mark's Mark's comments on the inventory, we have bulk drug substance and drug product inventory and they each have sequential dating on them. So that further extends that.
Mark Foley: But, you know, we've got a good amount of inventory with good dates on it, so we feel we're in a good position there. Toby for number two.
Toby Schilke: Yeah, perfect. And just to expand on Mark's comments on the inventory, we have both a drug substance and a drug product inventory, and they each have sequential dating on them. So that further extends that.
Toby Schilke: If you were to look, we just filed a Form 10-K, and we break down our R&D expenses a bit further. And if you were to look at the back schedule there, of the approximately $99 million of non-GAAP R&D expenses in the year 2021, 40% of that was for manufacturing costs, and the balance was between focal development costs and clinical expenditures.
If you were to look we just filed our Form 10-K , and we breakdown our R&D expenses a bit further and if you were to look at the back schedule there.
Approximately $99 million non-GAAP R&D expenses in the year 2021, 40% of that was on manufacturing costs and the balance was between <unk> development costs and clinical expenditures.
Toby Schilke: The local development costs will continue to be, we estimate to be flat, year on year, looking into 2022, whereas the clinical expenditures will continue to decline as we're not executing clinical trials, and that will be offset by the manufacturing costs for the vaccine, which are expensive in a period according to the gap. Thank you all. Thanks for watching.
The Opel development costs will continue to be we estimate to be flat year on year looking into 2022, whereas b. The clinical expenditures will continue to decline as we're not executing clinical trials and that will be offset by the manufacturing cost for <unk> that are expense in the <unk>.
According to GAAP.
Thank you all.
Thanks Mark.
Operator: Our next question will come from Tim Luzzo from William Blair. You may begin. Thanks for the question and congrats on what sounds like a productive type A meeting. Can you talk at all about how the sales force has shifted over the past two quarters following the CRL? I know RHA has done well, but I assume there may have been some attrition given the delayed launch. This is Dustin.
Our next question comes from the line of Tim Lugo from William Blair You may begin.
Thanks for the question and congrats on what sounds like a productive type a meeting can you talk at all how the sales force has shifted over the past two quarters following the CRM alike.
RSA is done well, however, I assume there may have been some attrition given the delayed launch.
Dustin Sjuts: Actually, our sales forces are in a really good place. We did not see any kind of break and trend as relates to any kind of turnover after the CRL. I think we feel confident that the revamped aesthetic strategy is a portfolio strategy, of course, anchored by Daxi, but those that have come into the organization see the value of RHA, see the value of Opal, see the value of how we're approaching the market for revamped aesthetics and are waiting and willing and ready and excited to sell Daxi upon approval.
Hey, Tim this is Dustin.
Our salesforce is a really good place we did not see any kind of break in trend as it relates to kind of turnover. After the CRM I think we feel confident that the revamped aesthetics strategy to portfolio strategy of course anchored by taxi, but those that have come into the organizations see the value of our <unk> issue the value they see the value of how.
We are approaching the market for advanced aesthetics, and are waiting and willing and ready and excited to sell back. The upon approval. So we did not see kind of a significant turn of course at the end of the year for all sales organizations. You typically have some kind of turnover, we feel that its been within healthy ranges. It didnt see a significant change just hope.
<unk>.
Our team here live International Global headquarters and training Center is the first time, our team got to see kind of the the.
Kind of high Tech investment we've made in towards the ejection centers innovate you and others and they left extremely excited and energized to sell R. J <unk> and our prepared upon <unk> approval.
Good to hear and maybe can you give us a little more granularity on the Q1 Q2 growth.
Patients.
I know coming out of Covid utilization and visits have been very strong across the aesthetics industry.
For these kind of typically seasonally strong quarters can you just are they going to be kind of turbo boost this year.
Mark Foley: I mean, you know, historically, as Dustin mentioned in the prepared Mark, there is seasonality in the business. So normally, Q4, Q1, you'll see a decline of kind of mid teens to high teens, given sort of the growth that we've seen in the market. You know, I think that Q4 benefited from that. So on a relative basis, even though Q1 is likely going to be up relative to Q4, that's probably a reasonable trend that you see.
Hey, Tim This is mark I mean historically.
As Dustin mentioned in the prepared remark there is seasonality in the business. So normally in Q4 to Q1, you'll see a decline.
Kind of mid teens to high teens.
Given sort of the growth that we've seen in the market.
I think that Q4 benefited from that so on a relative basis, even though Q1 is likely going to be up on a relative basis Q4 to Q1.
Probably a reasonable trend that you see and again, we would expect Q4 to be back up. So obviously, we're still in the earlier stages of launch and certainly there's headwinds and <unk>, obviously once taxis approved that will be a tailwind.
But that's the normal seasonal trend even with the growth that we've seen in the market.
Alright, thank you.
Mark Foley: All right, thank you. All right, next question. We'll come for a line of Douglas style from H.C. Winwright at the beginning.
Our next question will come from the line Douglas Tsao from H C. Wainwright you may begin.
Operator: Hi, good afternoon. Thanks for taking the questions. Just one clarification. So in terms of the manufacturing runs that have been completed, have you also completed the needed analytical work to characterize those runs? Or is that still part of the work that needs to be done for us in terms of putting together the resubmission?
Hi, good afternoon. Thanks for taking the questions just one clarification. So in terms of the manufacturing runs that have been completed have you also completed the needed analytical work to characterize those runs.
Or is that still.
Part of the work that needs to be done for us in terms of putting together the resubmission. Thank you.
Yeah, Doug So we have completed the analytical work associated with manufacturing.
Manufacturing batches.
We've completed the manufacturing activities related to those batches.
Okay, great. Thank you so much and congratulations.
Unknown Executive: Thank you. So we have completed the analytical work associated with those manufacturing batches, so we've completed the manufacturing activities related to those batches. Okay, great, thank you so much, and congratulations. [inaudible] Our next question comes from line up, Serge Belanger, from Needham. You may begin. Hi, this is Rohit on behalf of Serge. Thanks for taking my question. Just in terms of the Opal platform, how do you expect it to grow in 2022? Do you see Daxi as a growth driver for the platform when it gets released? Hey, this is Dustin.
Our next question comes from the line of Serge Belanger from Needham you may begin.
Hi, This is Robert on for Serge. Thanks for taking my question just in terms of the open platform. How do you expect it to grow in 2022 do you see <unk> as a growth driver for the platform when it gets on the market.
Dustin Sjuts: I'll start with the Opal platform. Yeah, we're definitely excited about Opal. As you know, we're in that next phase of now having a new platform, new technology with new features, and building on the foundation of what those features can add in terms of value for our current customers. We're also focusing this year on migrating those Hint MD customers over to the new platform, while also testing out these new features and expanding them.
I think this is dustin and I'll start with the open platform. Yes, we're definitely excited about opening as you know we are in that next phase of now having a new platform a new technology with new features and building on the foundation of what those features can add in terms of value for our current customers. We're also focusing this year.
On migrating those <unk> customers over to the new platform. While also testing out. These new features and expanding of course taxi is has a lot of pent up demand and excitement in the marketplace and we will have impact on Opal, we do see the value of all of these items kind of being a bit the link in the sense of Opel has a standalone value.
Dustin Sjuts: Of course, DAX has a lot of pent-up demand and excitement in the marketplace, and will have an impact on Opal. We do see the value of all of these items kind of being a bit de-linked in the sense that Opal has a standalone value, RHA has a standalone value, DAX has a standalone value, but then the combination can help all three in the right way.
Jay has standalone value taxi as standalone value, but then the combination can help all three are in the right account. So we're excited to continue the progression of Opel and bringing more value and services to the customer.
Dustin Sjuts: So we're excited to continue the progression of Opal and bring more value and services to the customer. Great, thank you. Thank you, and I'm not showing any further questions in the queue. I'd like to turn the call back over to Mark for any closing remarks. Thank you, operator. In the coming weeks, we plan to participate in the Cowan Health Care Conference and welcome your requests for meetings at this event or directly through us. Feel free to reach out to Jessica if you'd like to schedule some time.
Great. Thank you.
Thank you.
Showing any further questions in the queue I'd like to turn the call back over to Mark for any closing remarks.
Thank you operator in the coming weeks, we plan to participate in the Cowen Healthcare conference.
We welcome your requests for meetings at this event 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.
Mark Foley: With that, I would like to thank all of you for participating in today's call. This concludes today's conference call. Thank you for participating. You may now disconnect. Everyone have a great day.
Yeah.
This concludes today's conference call. Thank you for participating you may now disconnect everyone have a great day.
Okay.
[music].
Jessica Serra: Also, on today's call, we will present both Gap and non-Gap financial measures, a reconciliation of non-Gap to Gap's measures to include it in the orange release. But that I will turn the call over to Mark Foley, Chief Executive Officer of the Gap. Mark. Thank you, Jessica. Good afternoon, everyone.
Operator: Following management for paper marks, we will hold a Q&A session to ensure that we have ample time to address everyone's questions during the Q&A session. To ask a question at 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, Monday, February 28, 2022. I would now like to turn the conference call over to Jessica Serra, Head of Investor Relations and ESG for Revance. Please go ahead.
Mark Foley: And as we indicated, we will definitely put out a public announcement once we have refiled the BLA. So obviously, this is a high-level focus for us. And again, it's more administrative in nature at this point.
Dustin Sjuts: So we did not see a kind of significant turn. Of course, at the end of the year for all sales organizations, you could perhaps see some kind of turnover. We feel that it's been been within healthy ranges and didn't see a significant change. We just hosted our team here live at our National Global Headquarters and Training Center.
Mark Foley: And again, we would expect kind of Q4 to be back up. So obviously, we're still in the earlier stages of launch, and sort of there are headwinds and tailwinds. Obviously, you know, once the axis approves, that will be a tailwind. But, you know, that's the normal seasonal trend, even with the growth that we've seen in the market.
Mark Foley: In regards to the 483s, you know, previously we said there were 5483s in our responses to the agency on items 3 through 5, the agency indicated our responses appeared sufficient. And then for items 1 and 2, which is what we went into the type A meeting for it in that type A meeting coming out of that. You know, the thing the FDA wanted to see was the qualification of the new working sell bank with reconceptive drug substance and when the drug product that.
Dustin Sjuts: The first time, our team got to see kind of the kind of high second best we've made into toward the ejection centers, innovate you, and others. And they left extremely excited and energized to sell RHA, Opal, and are prepared to conduct your approval. Good to hear. And maybe you can give us a little more granularity on the Q1, Q2 growth expectations. You know, coming out of COVID, utilization and visits have been very strong across the aesthetics industry. You know, for these kind of typically seasonally strong quarters, you are just going to be kind of turbo-boosted this year. Ethan, this is Mark.
Mark Foley: So, you know, that's what we've been working on providing. In the actual complete response, we will need to just sort of update the clinical portion of our applications, you know, from a safety perspective. And is it related to the name, just another name search on that, that's pretty much it if we've been aware of that, and we're working on those activities in parallel. Great, thanks so much.