Q1 2021 Revance Therapeutics Inc Earnings Call

Welcome to the Vivat Therapeutics first quarter 2000, and shadow on the financial results and corporate update conference call.

Operator: the Revanced Therapeutics first quarter 2021 financial results and corporate update conference call. At this time, all participants are in the listen-only mode. Following management's prepared remarks, we will hold a Q&A session.

At this time all participants are in the listen only mode. Following management's prepared remarks, we will hold the Q&A session to ensure that we have ample time to address everyone's questions should you have any of the Q&A session.

Operator: that we have ample time to address everyone's questions during the Q&A session, we would ask for a limit of one question and one follow-up question per person. To ask a question at that time, please press star, followed by one on your touch-screen 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, May 10, 2021. I would like to turn the conference call over to Jessica Serra, head of investor relations and ESG for events. Please go ahead, ma'am. Thank you, Donna.

One of the limit of one session and one follow up question for person to ask the question at that time. Please press star followed by one audio Touchtone phone. If anyone has difficulty hearing of the conference call. Please press star zero for operator assistance as a reminder of this call is being recorded today.

And the tens of thousands of other one I would now like the turning the call conference call over to Jessica Sarah had a head of Investor Relations and ESG for events. Please go ahead ma'am.

Thank you Donna joining us on the call today from the van is President and Chief Executive Chief Executive Officer, Mark Foley, Chief Financial Officer, and Toby Schilke, Chief operating officer, and President of R&D and product operations, Dr. Joshi, Chief commercial officer of aesthetics and Therapeutics Dustin.

Jessica Serra: Joining us on the call today from Vance is President and Chief Executive Officer Mark Foley, Chief Financial Officer Toby Shilke, Chief Operating Officer and President of R&D and Product Operations, Dr. Apai Joshi, Chief Commercial Officer, Aesthetics and Therapeutics, Dust and Suits, and President of Innovation and Technology, Aubrey Rang. During this conference call, management will make forward-looking statements, including statements related to Revans's 2021 guidance, the clinical development of our product candidates, business strategy, and planned operations, commercialization plans, the timing and outcome of the FDA's inspection of our Northern California manufacturing facility, the potential benefits of our drug product candidates and technologies, the launch of the next generation Hinton Dysynthetic platform, the timing of any potential approval of Daxibotulatum toxin A for injection, and RJ1 by the FDA, the timing related to regulatory approval, submissions, and meetings, the market opportunity of our aesthetics and therapeutics franchises, the aesthetics industry, milestone expectations, and expect the cash runway, and financial performance.

And president of innovation and technology of ranking during.

During this conference call management will make forward looking statements, including statements related to prevent the 2020 one guidance the clinical development of our product candidates business strategy and planned operations commercialization plans and the timing and outcome of the Fda's inspection of our northern California, and manufacturing facility the potential benefits of <unk>.

The drug product candidates and technologies the launch of the next generation of hand from decent tech platform and the timing of any potential approval of the taxi botulinum toxin day for injection and RJ, one, but the F. D. A the timing related to regulatory approval submissions and meetings the market opportunity of our centex and therapeutics franchises.

That's the IDEXX industry milestone expectations and expect the cash runway and financial performance.

Jessica Serra: These forward-looking statements are based on the company's current expectations and inherently involve significant risks and uncertainty. Our actual results and the timing of events could defer materially from those anticipated and such forward-looking statements as a result of these risks and uncertainties. Factors that could cause results to be different from these statements include factors the company describes in the section titled Risk Factors in our current report on Form 10 Q to be filed with the SEC this afternoon on May 10, 2021. Revants undertakes no duty or obligation to update any forward-looking statements as a A reconciliation of non-gap to gap measures is included in the earnings release.

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 and such forward looking statements as a result of these risks and uncertainties.

Factors that could cause results to be different from these statements include factors. The company describes and the section titled Risk factors and our current reports on form 10-Q to be filed with the SEC. This afternoon on may 10th of 2020, one we've announced undertakes no duty or obligation to update any forward looking statements as a.

From new information future events or changes and its expectations.

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

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

Jessica Serra: With that, we'll turn over the call to Mark Foley. Mark?

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

Mark J. Foley: Thank you, Jessica. Good afternoon, everyone, and thank you for joining our first quarter 2021 Financial Results Conference Call. Before I cover the results and provide commentary for the first quarter, I'd like to provide an update on the BLA for our lead product, Vaxia Lina toxin A for injection for the Glavala line. Our standard operating procedure is to not comment on the status of our ongoing FDA review process or interactions with the agency.

Thank you Jessica and good afternoon, everyone and thank you for joining our first quarter of 2021 financial results Conference call.

Before I cover the results and provide commentary for the first quarter I'd like to provide and update on the BLA for our lead product the oxy botulinum toxin and April injection for Lamar and lives.

Our standard operating procedure is to not comment on the status of our ongoing FDA review process or interactions with the agency.

Mark J. Foley: However, given the unique environment that the COVID-19 pandemic has created and the length of time that has passed since our Purdue date, we felt that it was important to provide the investment community with an update. As of today, the FDA has not scheduled or conducted the pre-approval inspection of our Northern California manufacturing facility due to COVID-19 related travel restrictions.

However, given the unique environment that the COVID-19 pandemic has created and the length of time that is lost since the day, we felt that it was important to provide the investing community with an update as of <unk>.

Good day, the FDA is not scheduled to work conducted preapproval inspection of our northern California manufacturing facility due to COVID-19 related travel restrictions.

Mark J. Foley: While we had expected to have an inspection date by now, we continue to engage with the FDA and leverage all available resources to facilitate an inspection as soon as possible. We're also encouraged to see the FDA recently issue its most comprehensive guidance to date, which outlines the agency's planned inspection approach going forward. Combined with the ramp-up and vaccinations across the country, and the decline in COVID cases, particularly in the geographic area of our manufacturing site, we anticipate that we will be provided with an inspection date in the near term.

The expected to have and inspection date by now we continue to engage with the FDA and leverage all available resources to facilitate and inspection as soon as possible.

We're also encouraged to see the FDA recently issued its most comprehensive guidance today, which outlined the agency plan and inspection approach going forward.

Combined with the ramp up and vaccinations across the country, the decline and COVID-19 cases, particularly and the geographic area of our manufacturing site. We anticipate that we will be provided and inspection date in the near term.

Mark J. Foley: Furthermore, we will now make an announcement once we receive the official communication from the FDA regarding our inspection timing. As a reminder, the approval of our BLA by the Feduf on the date of November 25th, 2020, was deferred due to FDA's inability to conduct an inspection of our facility due to COVID-related travel restrictions. Importantly, the FDA did not indicate any other outstanding review issues beyond the pending inspection, and we did not receive a complete response letter.

Furthermore, we will now make an announcement once we receive the official communication from the FDA regarding our inspection timing.

As a reminder of the approval of our BLA by the <unk> date of November 25, 2020 was deferred due to the F. D. A inability to conduct and inspection of our facility due to COVID-19 related travel restrictions and importantly, the FDA did not indicate any other outstanding review issues beyond the pending inspection and we did not.

<unk> received the complete response letter.

Mark J. Foley: We remain ready to support an on-site inspection as soon as the agency is able to visit our facility, and we continue to build drug product inventory in anticipation of approval and are eager to introduce this unique product into the aesthetics market. Now, let me turn to our first quarter performance. Following our successful transition into a commercial entity in late 2020, we're very pleased to see the momentum in our aesthetics franchise continue in the first quarter of 2021.

We remain ready to support and onsite inspection as soon as the agency is able to visit our facility.

And we continue to build drug product inventory in anticipation of approval and are eager to introduce this unique product into the aesthetics market.

Yeah.

Now, let me turn to our first quarter performance.

Following our successful transition into a commercial entity and late 2020, we're very pleased to see the momentum and our Fedex franchise continue and the first quarter of 2021.

Mark J. Foley: We delivered strong revenue from our RHA collection of dermal fillers and saw a robust increase in processing volumes from the HNMD FinTech platform, despite the impact of COVID-19 and Q1, historically being a seasonally slower quarter for facial injectables. These results confirmed the market demand for our innovative and premium products and services and further validated our targeted launch strategy. 2021 will undoubtedly be another exciting year for the company with a focus on ongoing successful commercial execution. That said, our playbook for the year is anchored by five strategic priorities.

We delivered strong revenue from our <unk> collection of dermal fillers and saw robust increase and processing volumes from the NMB Fintech platform. Despite the COVID-19, despite the impact of COVID-19, and Q1, historically being the seasonally seasonally slower quarter for facial injectables.

These results confirmed the market demand for our innovative and premium products and services and further validated our targeted launch strategy.

2020, one will undoubtedly be another exciting year for the company with a focus on ongoing successful commercial execution.

That said our playbook for the year is anchored by five strategic priorities.

Mark J. Foley: First and foremost, our company's strategic priority is to obtain FDA approval for our lead neuromodulator product, Dactubotuline and Toxene A for injection, and to launch the product with the same targeted approach that we used for the RHA collection and HintMD platform. Our second strategic priority is to deliver on our commercial strategy and aesthetics. We're driving market segmentation with our premium products and prestige launch strategy, targeting elite practices and partners. Looking ahead, we are excited about broadening our aesthetics portfolio with the introduction of RHA1 once approved and the next version of the HintMD platform.

First and foremost is obtaining FDA approval on our bead neuromodulator product the oxy botulinum toxin, a free injection and launching the product with the same targeted approach we used for the <unk> collection and hit and the platform.

Our second strategic priority is to deliver on our commercial strategy and aesthetics, we're driving market segmentation with our premium products and prestige launch strategy targeting elite practices and partners.

Looking ahead, we are excited about broadening our aesthetics portfolio with the introduction of <unk> once approved and the next version of the hit from the platform.

Mark J. Foley: We are excited about our progress and aesthetics, and Dustin will cover more on that later in the call. Our third strategic priority relates to our therapeutics franchise, where we plan to bring the clinically proven benefits of Dacthubotulinum Toxia to muscle movement disorders and set a new standard of care for patients. With the expected completion of our Phase 3 Open Label Safety Study in cervical dystonia and submission of our end of phase two meeting requests in adult upper limb spasticity, or AULS, this year, we've begun building the commercial foundation for our therapeutics franchise, and I'll expand on that later in the call. Our fourth strategic priority is the continued focus on discipline and capital allocation.

We are excited about our progress and aesthetics and duston will cover more on that later on the call.

Our third strategic priority relates to our therapeutics franchise, where we plan to bring the clinically proven benefits of the oxy botulinum toxin, a and the muscle movement disorders and set the new standard of care for patients.

With the expected completion of our phase III open label safety study and cervical dystonia and submission of our end of phase II meeting request and adult upper limb spasticity or L. S. This year, we have begun building the commercial foundation for our therapeutics franchise and I'll expand on that later in the call.

Our fourth strategic priority is the continued focus on disciplined capital allocation.

Mark J. Foley: We entered 2021 with a strong balance sheet and cash cashed into 2024. We continue to execute on our strategy from a position of strength and are focused on ensuring that the investments we make today will allow us to realize our near-term growth objectives while also supporting our long-term strategic initiatives. Our fifth and final strategic priority for 2021 relates to our people initiatives, which are critical to our ability to drive sustainable growth in the years ahead. Revanced more than doubled in size last year, opened offices in three additional cities, and established a national sales organization.

We entered 2021 with a strong balance sheet and cash and a 2024.

We continue to execute on our strategy from a position of strength and are focused on ensuring that the investments. We make today will allow us to realize our near term growth objectives. While also supporting our long term strategic initiatives.

Our fifth and final strategic priority for 2020, one relates to our people initiatives, which are critical to our ability to drive sustainable growth and the years ahead.

We may have more than doubled in size last year opened offices and three additional cities and established the national sales organization.

Mark J. Foley: Our ability to build a strong culture and a working environment where all employees feel welcome, supported, and empowered is critical. This is important not only for attracting and retaining talent but also for fostering greater innovation in business outcomes. Throughout it all, we continue to lean in on our commitment to diversity and inclusion. In summary, we feel very good about where we are positioned and where we are headed. We've delivered two consecutive quarters of solid commercial results through our targeted launch strategy, amassed a growing body of clinical data supporting the consistent and differentiated performance profile of Daxubotuline and Toxia, maintained a strong financial profile, and lastly, built an incredibly talented and dedicated team, coupled with the key catalyst for this year, most notably the anticipated FDA approval of our lead neuromodulator product.

And our ability to build a strong culture and of working environment, where all employees feel welcome supported and empowered is critical.

Is important not only for attracting and retaining talent, but also for fostering greater innovation and business outcomes throughout it all we continue to lean in on our commitment to diversity and inclusion.

In summary, we feel very good about where we're positioned and where we're headed.

We have delivered two consecutive quarters solid commercial results through our targeted launch strategy amassed a growing body of clinical data supporting the consistent and differentiated performance profile of the oxy botulinum toxin day.

The maintained the strong financial profile, and lastly, built and incredibly talented and dedicated team.

Coupled with the key catalysts for this year, most notably the anticipated FDA approval of our lead neuromodulator product, we look forward to delivering another year of significant growth.

Mark J. Foley: We look forward to delivering another year of significant growth. With that, I'll turn the call over to Dustin, who will discuss the performance of our aesthetics business in the first quarter. Thank you, Mark. We started off the year squarely focused on executing our commercial strategy and optimizing our aesthetics infrastructure to support growth at scale. Our heads-down mentality paid off.

With that I'll turn the call over to Duston, who will cover the performance of our aesthetics business and the first quarter.

Thank you Marc we started off the year squarely focused on executing our commercial strategy and optimizing our infrastructure to support growth at scale are heads down mentality paid off as we exceeded our internal expectations for both our H eight and symptom data reporting of 11 6 million and total sales.

Dustin S. Sjuts: as we exceeded our internal expectations for both RHA and Hint MD, reporting $11.6 million in total sales and exiting the first quarter with a run rate of over $400 million in processing volume. We ended the quarter with over 1,500 accounts across RHA and HintmD, which is a substantial increase from the approximately 1,000 accounts we reported at year end 2020. These results were driven largely by our efforts to forge strong inroads with key elite practices and partners.

And exiting the first quarter with the run rate of over 400 billion and processing volume.

We ended the quarter with over 500 accounts across our H E and Hinton D, which is the substantial increase from the approximately 1000 accounts, we reported at year end 2020.

These results were driven largely by our efforts to forge strong inroads with key elite practices and partners more and more of elite practices are embracing the opportunities to Bryan to provide their clients with added value through innovation elevated outcomes and superior service.

Dustin S. Sjuts: More and more elite practices are embracing the opportunities to provide their clients with added value through innovation, elevated outcomes, and superior service. We're very encouraged by the early credibility we are establishing with the RANs aesthetics brand through the launch of RHA and HintMD. Our strong results for the quarter were also supported by a ramp-up of injector education programs to revance you. With increased vaccinations across the country, we were able to conduct more face-to-face trainings while also leveraging our robust virtual training platform. In fact, we began conducting training inside doctors' offices for the first time last month and attended our first in-person medical conference, an aesthetic meeting in Miami.

We're very encouraged by the early credibility, we are establishing with the romance of Fedex brand through the launch or a J and interim data.

Our strong results for the quarter also supported by a ramp up of injector education programs to advance you with increased vaccinations across the country, we were able to conduct more face to face training. While also leveraging our robust virtual training platform. In fact, we bet began conducting training inside the doctor's offices for the first time last month.

And attended our first in person Medical conference your static meeting in Miami.

Dustin S. Sjuts: These trends all point to the recovery of the aesthetics industry, which we believe will serve as a tailwind to our commercial story in the month ahead. During the quarter, we also prioritized consumer activation in multiple ways. We created and distributed a suite of content to be used by practices and across their social media, website, and CRM Plus. We also continued our Flaw Motion Consumer Initiative through a targeted digital campaign across channels with the goal of driving more clients to practices that carry the RHA collection.

These trends all points of the recovery of the aesthetics industry, which we believe will serve as a tailwind to our commercial story in the months ahead.

During the quarter, we also prioritize consumer activation and multiple ways, we created and distributed a suite of content to be used by practices and across the social media website and CRM platforms. We also continued our flawless and motion of consumer initiatives through and targeted digital campaign across channels with the goal of driving more clients.

The practices that carry the IHA collection.

Dustin S. Sjuts: Turning to HintmD, we were very pleased to see the processing volume run rate more than double in the quarter. This was largely due to increased account penetration complemented by a rise in cosmetic and aesthetic procedures as the broader economy opened up.

Turning to hit the MD, we're very pleased to see the processing volume run rate more than doubled and the quarter.

This was largely due to the increased account penetration complemented by a rise and cosmetic and aesthetic procedures as the broader economy opened up.

Dustin S. Sjuts: The adoption rate for HintmD benefited from the cross-selling opportunities generated by our salesperson. Many practices that adopted RHA are recognizing HintmD as a complementary aesthetic service that not only optimizes payment solutions but also has the potential to increase practice economics with future features such as subscription services, patient wallet, white label loyalty, and data analytics. HintmD is the first and only aesthetics-focused fintech platform. And unlike current loyalty and promotional programs offered in the aesthetics market today, HintmD has the potential to build customer loyalty with the practice as opposed to a specific brand. For these reasons, practices are leaning in.

The adoption rate for hints MD benefited from the cross selling opportunities generated by our sales team. Many practices that adopted <unk> are recognizing the anthem D. As a complementary aesthetic service, but not only optimize payment solutions, but also has the potential to increase practice economics with future features such as subscription services.

And wallet white label loyalty and data analytics and empty as the first and only aesthetics focused and fintech platform and unlike current loyalty and promotional programs offered and the aesthetics market today and somebody has the potential to build customer loyalty with the practice as opposed to a specific brands.

And for these reasons practices are leaning in.

Dustin S. Sjuts: Our near-term focus is to further increase the number of accounts on the platform and launch the next release of HintmD. We're in the beta phase of this release, and we are on track for launch in the coming month. We believe the integration of PAYFAC will unlock tremendous value for both Revans and our customers alike. As a payment facilitator, we will be able to participate in more of the credit card processing value chain, thereby increasing our margins on the transactions processed over time. Furthermore, since Payfax sits right at the transaction level, we'll be able to leverage the source data to build new features and functionality and enhance practice economics and customer loyalty.

Our near term focus is to further increase the number of accounts on the platform and launched the next release of him Tim day, when the beta phase of this release and are on track for launch in the coming months.

We believe the integration of pay fact will unlock tremendous value for both of our van and our customers of light as a payment facilitator, we will be able to participate and more of the credit card processing value chain, thereby increasing our margins on the transactions processed over time.

Further since the payback sits right at the transaction level, we will be able to leverage the source data to build new features and functionality and enhanced practice economics and customer loyalty.

Dustin S. Sjuts: We also strengthened our commercial infrastructure during the quarter so that it can support our growth at scale. We are near the final stages of building out our national corporate headquarters and experience center, which will serve as a key training and education hub for employees, practices, and partners. Our Experience Center will be the first of its kind in the industry, and we're excited to showcase our differentiated approach to enhancing learning and expanding access to our brand and product portfolio. In April, we successfully and safely hosted our second live national sales meeting, which included in-person training for our sales force, further equipping our team with the tools and resources needed to continue to grow the aesthetics franchise.

We also strengthened our commercial infrastructure during the quarter, so that can support our growth at scale.

We are near the final stages of building out our Nashville, corporate headquarters and experience center, which will serve as the key training and education hub for employees practices and partners.

Our experience center will be the first of its kind of and the industry and we're excited to showcase our differentiated approach to enhancing learning and expanding access to our brand and product portfolio.

And April we successfully and safely hosted our second live national sales meeting.

The meeting included in person training for our sales force further equipping our team with the tools and resources needed to continue to grow aesthetics franchise.

Dustin S. Sjuts: Overall, a very active first quarter on the commercial end as we continue to focus on execution. Now I'll turn the call over to Mark to discuss our therapeutics franchise. Thanks, Dustin.

Overall, a very active first quarter on the commercial and as we continue to focus on execution.

Now I'll turn the call over to Mark to discuss our therapeutics franchise arc.

Thanks to us and we're pleased to see our therapeutic opportunity and muscle movement disorders continue to advance this quarter and February we reported positive results from our Juniper phase II trial, Dachsie botulinum toxin and per injection for the treatment of adult upper limb spasticity.

Mark J. Foley: We're pleased to see our therapeutic opportunity and muscle movement disorders continue to advance this quarter. In February, we reported positive results from our Juniper Phase 2 trial, Daxiboculinum toxinate for injection for the treatment of adult upper limb spasticity. The study provided us with the necessary data to support our dosing strategy for the Phase 3 program. It also showed the consistent 24-week duration profile of doxyboculine and toxinase for injection as seen across our cervical dystonia clinical program and our set of clinical trials.

The study provided us with the necessary data to support our dosing strategy per phase III program.

It also shows the consistent 24 week duration profile of the oxy botulinum toxin nave per injection of seen across our cervical dystonia clinical program and our set of clinical trials.

Mark J. Foley: With the completion of our Phase 3 open label safety study in cervical dystonia, and an A-ULS and Phase 2 meeting planned for the second half of this year, the commercial path for our therapeutics franchise is beginning to take shape. For our cervical dystonia program, which is the furthest along in development, we plan to complete our regulatory filing with the FDA in 2022 and anticipate approval in 2023. There is meaningful value to be unlocked in the muscle movement disorders category.

And with the completion of our Phase III open label safety study and cervical dystonia and a U L S and the phase II meeting planned for the second half of this year the commercial path for our therapeutics franchise is beginning to take shape.

Our cervical dystonia program, which is the furthest along and development we plan to complete our regulatory filing with the FDA and 2022 and anticipate approval and 2023.

There is meaningful value to be unlocked and the muscle movement disorders category.

Mark J. Foley: The global market for cervical dystonia and spasticity, which includes upper and lower limb spasticity, is currently valued at over $1 billion and is projected to exceed $1.5 billion by 2025. Importantly, nearly 80% of that opportunity resides within the United States, representing a significant opportunity for research and development.

The global market for cervical dystonia, and spasticity, which includes upper and lower limb spasticity is currently valued at over $1 billion and is projected to exceed $1 $5 billion by 2025 and.

Importantly, near the 80% of that opportunity resides in the United States, representing a significant opportunity for revamps and.

Mark J. Foley: We're excited about the prospects of leading this market with our next generation neuromodulator, given the drug's safety and efficacy in providing symptom relief and its unique duration profile that has the ability to cut the number of required treatments by half. In short, Axibachyloininin A has the potential to not only provide a better treatment to patients but also bring substantial pharmacoeconomic benefits to the healthcare system. Based on our progress, we are beginning to focus on our go-to-market strategy while strengthening our internal infrastructure to support our transition from the clinical stage to commercial and therapeutics.

We're excited about the prospects of leading this market with our next generation neuromodulator, given the drug safety and efficacy and providing symptom relief and its unique duration profile and has the ability to cut the number of required treatments by half.

In short after the botulinum toxin, a and the potential and to not only provide a better treatment to patients, but also brings substantial pharmacopeia economic benefits to the health care system.

Based on our progress we are beginning to focus on our go to market strategy, while strengthening our internal infrastructure to support our transition from clinical stage to commercial and therapeutics to.

Mark J. Foley: To that end, we have been focused on building out our therapeutics leadership team and have made several key hires in promotions, including our newest appointment, Angela Willis, who will serve as our vice president of market access. Angela has more than 20 years of experience in biopharmaceutical market access and pricing strategy across multiple therapeutic areas, including neurology and migraine. We're excited about the strong team we have in place, which will support our growth in therapeutics in the years ahead.

So that and we have been focused on building out our therapeutics leadership team and have made several key hires and promotions, including our newest appointment Angela Willis who will serve as our vice president of market access.

Angela has more than 20 years of experience and Biopharma market access and price can strategy across multiple therapeutic areas, including neurology and migraine.

We're excited about the strong team, we have in place, which will support our growth and therapeutics and the years ahead.

Mark J. Foley: Before I turn the call over to Toby, I would like to briefly touch on the recent advancements in our partnership. In April, we announced that Shanghai Poston Pharmaceutical Industrial Company enrolled and injected their first patients in their face three trials, Daxibachiline, for glabella lines and cervical dystonia in China.

Before I turn the call over to Toby I would like to briefly touch on the recent advancements in our partnerships and April we.

We announced the Shanghai boats, and pharmaceutical and industrial company enrolled and injected their first patients and their phase III trials. The Doxy botulinum toxin day from glabella lines, and cervical dystonia and China.

Tobin C. Schilke: China is the second largest neuromodulator market in the world, and we are excited about our potential to establish a foothold in this attractive market for a great partner like both. Finally, we are pleased that our biosimilar collaboration with Beatrice is also progressing nicely. We recently submitted the briefing package for a biosimilar to Botox to the FDA for agreement on a page three program. This is an encouraging development and shows our ability to participate in the short-acting neuromodulator category while we prepare for the launch of our longer-acting neuromodulator in both aesthetics and therapeutics. With that, I will now turn the call over to Toby to cover their first quarter financials. Thanks, Mark.

China is the second largest neurologic neuro neuromodulator market and the world and we are excited about our potential to establish a foothold and this attractive market for a break partner like Boston.

Finally, we are pleased that our biosimilar collaboration with the interest is also progressing nicely.

We recently submitted the briefing package for a biosimilar to botox to the FDA per agreement on the Phase III program.

And as an encouraging development and our ability to participate and the short acting neuromodulator category, while we prepare for the launch of our longer acting neuromodulator and both aesthetics and therapeutics.

With that I will now turn the call over to Toby to cover the first quarter financials.

Thanks, Mark the earnings release, we issued today outlines our financial results and full so I'll touch on the highlights on this call.

Tobin C. Schilke: The earnings release we issued today outlines our financial results in full, so I'll touch on the highlights on this call. Total revenue was $13.3 million for the first quarter, which included $11.6 million in RHA collection revenue, $1.5 million from our partnership with Vatris on the biosimilar to Botox, and $0.1 million from our Hintmd Fintech platform. As Dustin mentioned earlier, HintmD's processing volume run rate increased to over $400 million during the quarter. However, revenue growth for the quarter lagged processing volume growth, primarily because new practices received payment devices that were accounted for as contra revenue. As we have indicated before, processing volume is the best way to measure the growth and performance of the HintmD platform.

Total revenue was $13 $3 million for the first quarter, which included $11 $6 million and RH, a collection revenue $1 $5 million from our partnership with VA interest on the Biosimilar to Botox and zero point $1 million from our hint MD pinta.

<unk> platform.

As Dustin mentioned earlier and <unk>.

These processing volume run rate increased to over $400 million during the quarter.

Revenue growth for the quarter of lagged processing volume growth, primarily because new practices received payment devices that were accounted for as a contra revenue as.

And as we've indicated before processing volume is the best way to measure the growth and performance of the hint of MD platform. It is the leading indicator for both account penetration and account processing activity, which directionally translates to our revenue potential.

Tobin C. Schilke: It is the leading indicator for both account penetration and account processing activity, which directly translates to our revenue potential. Turning to operating expenses, selling, general, and administrative expenses for the first quarter of 2021, or $49 million, reflecting sales and marketing expenses related to the RHA collection of dermal fillers, pre-commercial activities for Daxibachilina, and A, and headcount-related expenses for HintMD. SGNA expenses include depreciation and amortization and stock-based compensation. Excluding these expenses, non-gap SG&A expenses were $40.8 million for the first quarter of 2021.

Turning to operating expenses.

Selling general and administrative expenses for the first quarter 2021 or $49 million, reflecting.

The reflecting sales and marketing expenses related to the <unk> collection of dermal fillers pre commercial activities for Dachsie botulinum, AA and head count related expenses for him empty.

SG&A and a expenses include depreciation and amortization and stock based compensation.

Excluding these expenses non-GAAP SG&A expenses were $48 million for the first quarter 2020 one.

Tobin C. Schilke: Research and Development expenses for the first quarter 2021 totaled $27.3 million, reflecting costs related to clinical trials, regulatory support for ongoing biologics license applications, and other developmental efforts. R&D expenses include depreciation and amortization and stock-based compensation. Excluding these expenses, non-gap R&D expenses were $23.5 million for the first quarter 2021. Total Gap operating expenses were $83.

Research and development expenses for the first quarter 2021 totaled $27 $3 million, reflecting costs related to clinical trials regulatory support for ongoing biologics license application and other developmental efforts R&D expenses include depreciation and <unk>.

Amortization and stock based compensation, excluding these expenses non-GAAP R&D expenses were $23 $5 million for the first quarter 2021.

Total GAAP operating expenses were $83 3 million for the first quarter.

Tobin C. Schilke: $1 million for the first quarter. Excluding stock-based compensation, depreciation, and amortization, and costs of revenue, non-gap operating expenses were $64.2 million for the quarter. We continue to be in a strong financial position from McBalanchee's perspective. Cash, Cash Equivalents, and Short-Term Investments as of March 31, 2021, or $386.8 million, which we believe is sufficient to fund our operating plan into 2024. In terms of outlook, we are confirming our previously announced 2021 GAAP operating expenses of between $375 to $390 million and non-GAAP operating expenses of between $270 to $285 million.

Excluding stock based compensation depreciation and amortization and cost of revenue non-GAAP operating expenses were $64 $2 million for the quarter.

We continue to be and a strong financial position from a balance sheet perspective.

Cash cash equivalents and short term investments as of March 31, 2021, or $386 8 million, which we believe is sufficient to fund our operating plan into 2024.

In terms of outlook, we are confirming our previously announced 2021 GAAP operating expenses of between $375 million to $390 million and non-GAAP operating expenses between 270 to 280 $85 million.

Tobin C. Schilke: We expect 2021 non-gap research and development expenses, including HinMB, to be $95 to $105 million. Finally, Revances shares outstanding as of April 27, 2021, were approximately 71. 71.5 million, with 66.5 million fully diluted shares, excluding the impact of convertible debt.

We expect 2021, non-GAAP research and development expense, including and MB to be $95 million to $105 million.

Finally revamp the shares outstanding as of April 27, 2021 were approximately $71 5 million with $66 5 million fully diluted shares excluding the impact of convertible debt and with that I'll now turn the call back over to Mark.

Mark J. Foley: And with that, I'll now turn the call back over to Mark. Thank you, Toby. In closing, we delivered a strong start to the year in both our aesthetics and therapeutics franchises and believe we are well positioned for continued growth with a number of important upcoming catalysts. 2021 will be another pivotal year for Revans, and we look forward to updating all of you on the progress we are making on our key priorities throughout the year.

Thank you Tobey and closing we delivered a strong start to the year and both of our aesthetics and therapeutics franchises and believe we are well positioned for continued growth with the number of important upcoming catalysts 2021 will be another pivotal year for rebounds, and we look forward to updating all of you on the progress we're making on.

Our key priorities throughout the year.

Mark J. Foley: Lastly, I want to take this opportunity to thank our team for their tireless commitment to the company and efforts in the support of each other. The COVID-19 pandemic has placed a tremendous strain on so many employees and their families, yet they have found a way to not only persevere but successfully adapt to allow us to achieve our goals. With that, I will now open up the call to questions. Operator?

Lastly, I want to take this opportunity to thank our team for their tireless commitment to the company and efforts and the support of each other the <unk>.

Moving 19 pandemic has placed the tremendous strain on so many employees and their families get the have found a way and not only per severe but successfully adapt to allow us to achieve our goals.

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

Operator: As a reminder to ask a question, you will need to press star one, then the number one on your turn.

As a reminder to ask the question you will need to press star one and the number one and I know Touchstone zone, we will pause switches from the woman to compile the Q&A last day.

Operator: and you will need to press star 1, then the number one on your touchstone phone. We will pause for just a moment to compile the Q&A roster. Your first question comes from the line of Kent, Katja Torre, from Cowan and Company. Your line is now open.

Yes.

Your first question comes from the line of Ken Cacciatore from Cowen and company. Your line is now open.

Unknown Attendee: Thanks, guys. Just a really wonderful performance, just unexpectedly strong. So congratulations to you all. Just wondering, as we're clearly a little bit delayed on Daxi than we would have hoped, you're obviously able to establish relationships with the clinicians in a way differently than you probably thought when you were originally going to be introducing the products. So just wondering, how does that help you accelerate any part of your original game plan? Does it allow you to maybe accelerate DTC once you get it?

Thanks, guys, just really wonderful performance just unexpectedly strong so congratulations to you all just wondering as were clearly a little bit the lead further on taxi than we would've hoped you're obviously able to establish relationships with the clinicians and a way of differently than you probably thought when you were originally going to be.

Introducing the products I was just wondering how does that help you accelerate any part of your original game plan does that allow you to maybe accelerate DTC once you get sort of.

Mark J. Foley: get to a certain level of training, just trying to understand how the connectivity maybe changes the way when we finally do get Daxi, you'll approach it. And then wondering about the inspection. You've had a little bit of time now, more time to prepare. Can you talk about what you've done behind the scenes? Are you having consultants do mock walkthroughs? Is there any kind of corrective action you've been able to take just to really make sure that we nail it the first time around?

Certain level of training just trying to understand.

How the connectivity maybe changes the way when we finally do get taxi of you'll approach it and and then wondering on the inspection you've had a little bit of time now more time to prepare just can you talk about what you've done and behind the scenes of you having consultants do mark walked through is there any kind of corrective action and you've been able to take just to really make sure that we know it.

The first time around thanks, so much.

Mark J. Foley: Thanks so much. Yeah, thanks, Ken. So first off, in terms of, you know, the delay in our neuromodulator and the impact, yeah, as you point out, the great thing about having the suite of products and services that we have is that, you know, our strategy is based on the combination in our portfolio. So with the RHA line of fillers, I think, if anything, it's allowed us to lean in more on the fillers and really do a good job of to be the lead there.

Yeah. Thanks, Ken So first off in terms of the delay and our neuromodulator and the impact Yes, you point out the great thing about having the suite of products and services that we have is that our strategy is based on the combination of our portfolio.

With the RH a line of pillars, and I think if anything it's allowed us to lean and more on the fillers and really do a good job of highlighting the benefits of the product line versus sort of leaning on our neuromodulator to be the lead there. So we're obviously very encouraged by the traction that we're getting and the feedback that we're getting on the overall portfolio.

Mark J. Foley: So we're obviously very encouraged by the traction that we're getting and the feedback that we're getting on the overall portfolio. And as you point out, obviously, with an expanding group of relationships that we're establishing in the market, by the time that we do ultimately kind of broadly launch our neuromodulator product, we will certainly be doing that with a broader set of relationships and an entrenched partnership. So we do think that, over time, we'll certainly be able to leverage the traction that we're seeing in the market today.

<unk> and as you point out obviously with and expanding group of relationships that were established and the market by the time that we do ultimately kind of broadly launch of our neuromodulator product, we will certainly be doing that with a broader set of relationships and entrenched partnership. So we do think that over time certainly.

And we'll be able to leverage the traction that we're seeing and the market today.

Mark J. Foley: On the, you know, the overall preparation side of it, absolutely. You know, our team did a great job of taking sort of advantage of this downtime where we were engaged with outside consultants and experts to do mock audits and pressure test our systems. And, you know, we are actively building inventory in preparation for our launch. So, you know, things aren't changing there. We've actually trained our sales force as well. And so, you know, we continue to be leaning in. And, you know, we continue to be leaning in.

On the you know the overall preparation side of it absolutely.

Our team has done a great job of of taking sort of advantage of this downtime, where we have been engaged with outside consultants and experts to do mock audits to pressure test our systems and we are actively building inventory and preparation for our launch so things are changing there we've actually trained our sales force as well and so we continue.

To be leaning in and.

Mark J. Foley: will certainly be ready once approval comes. Thanks so much. Thanks, thanks. Thank you. Your next question comes from the line of Cines from Guggenheim. Your line is now open.

We'll certainly be ready once approval comes.

Okay. Thanks, so much.

Thanks.

Thank you. Your next question comes from the line of Seamus Fernandez from Guggenheim. Your line is now open.

Operator: Oh, great, thanks. So just a couple of quick questions, guys, and congratulations on a great quarter as well.

Great. Thanks, So just a couple of quick questions guys.

And congrats on a great quarter as well.

The on the debt.

Unknown Attendee: On the share market that you guys are seeing at this point, in terms of the uptake in the practices that you're in, can you just maybe give us a sense of directionally how the RHE fillers are performing within that bucket? And really where you're seeing the use of the product, you know, have its biggest, it's biggest, biggest impact.

The share of market that you guys are seeing at this point.

In terms of the uptake in the practices that you're in.

Can you just maybe give us a sense of of Directionally how.

The the Archie pillars are performing.

Within that.

The debt that bucket and.

And and really where youre seeing the the use of the product.

Unknown Attendee: And then, you know, the second question, just as we think about

Habits its biggest.

The biggest impact and then the second question just as we think about.

Unknown Attendee: The opportunity for Daxi, you know, obviously your execution has been very impressive. What really would you say are the kind of biggest headwinds from a competitor perspective? Is it, you know, do you feel like it's pricing? Is it just, you know, feet on the ground? You know, obviously I know

The.

The opportunity for Dachsie.

Obviously your execution has been very impressive.

And what really would you say are kind of the biggest headwinds.

From a competitor perspective.

Is it do you feel like it's pricing is it just you know feet.

Feet on the ground.

Unknown Attendee: You guys are going to be fully resourced to get after this, but you know, given the launch of the fillers, you know, it would see

Obviously, I know you guys are going to be fully resource to get after this.

But given the launch of the fillers.

Unknown Attendee: Given the launch of the fillers, you know, it would seem like the opportunity is quite significant once you actually have the product available. Great, thanks, Seamus. So we'll take the first part of the first one and then have Dustin comment on sort of the use of the product and kind of where we're seeing it. I would break it down in kind of four buckets.

It would seem like the opportunity is quite significant.

Once you actually have the product available. Thanks.

Great. Thanks, Seamus So maybe I'll take the first part of the first one and then have dusted and comment on sort of of the use of product and kind of where we're seeing it I would break it down and kind of four buckets. We're still obviously early and are overall ramp and.

Mark J. Foley: You know, we're still obviously early in our overall ramp and, you know, better understanding what the overall account adoption profile is going to look like. So we've got some accounts that are leaning and heavy. They like the product. They think it's, you know, the best product out there. And so we're getting a majority of their filler share because they've made the decision, either through the product, the relationship, the strategy, the no advertised pricing, the prestige approach, that this is kind of really going to be the main sort of workforce, you know, line of products for them. The second group are those that have leaned in.

Better understanding what the overall account adoption profile is going to look like so we've got some accounts that are leaning in heavy and they liked the product. They think it's the best product out there and so we're getting the majority of their filler share because they've made the decision either through the product the relationship the strategy the new advertising.

Pricing the prestige approach that this is kind of really going to be the the main sort of work force line of products for them.

The second group are those that have leaned in and they really like the products, but they're only going to give us so much share until our neuromodulator product comes into the market because they don't want to break up the bundle and incur higher pricing across the other products and so and that we are.

Mark J. Foley: They really like the product, but they're only going to give us so much share until our neuromodulator product comes into the market because they don't want to break up the bundle and incur higher pricing across their other products. And so in that, they like the product. They will definitely use it, but they will cap the limit the usage until we have their neuromodulator. We then have, you know, the next group of customers who are using it, and they've found sort of where it fits for them independent of pricing.

And the like the products they will definitely use it but they will cap the limit the usage and until we have the neuromodulator. We then have the next group of customers, who are using it and they found sort of where it fits for them independent of pricing I like it for this and here's where I'm using it and then we have some of those other accounts that have tried it for whatever reason.

Mark J. Foley: I like it for this, and here's where I'm using it. And then we have some of those other accounts that have tried it for whatever reason. It's not the right product for them. Either, hey, come back and talk to me when your neuromodulators are approved because the pricing. I don't want to break up the bundle.

Not the right product for them either.

Hey come back and talk to me when Youre Neuromodulators approved because the pricing I don't want to break up the bundle I like it here, but I feel I've got alternatives and so we've got a broad range, but obviously with the performance that we've had now for two consecutive quarters. The strategy is working the story is resonating, we're disciplined and sort of the accounts.

Mark J. Foley: I like it here, but, you know, I feel I've got alternatives. And so we have a broad range. But obviously, with the performance that we've had now for two consecutive quarters, the strategy is working, the story is responding. We're disciplined, and sort of the accounts that we're going after that really see value in the prestige category. And so as we get further into the launch, I think we'll have a better sense for kind of how those, you know, buckets are shaking out.

We're going after that when we see value and the prestige category and so as we get further end of the launch I think we'll have a better sense for kind of how those.

Mark J. Foley: And then I think it has the ability to morph again once we have the neuromodulate in the market. I don't know, Duffin, if you want to talk about kind of where we're seeing product usage, more specifically. Yeah, I think, you hit it on the head, a hit that there's variability, right? You've got some accounts using it more than others.

Buckets are shaking out and then I think it has the ability to more of again once we have the neuromodulator in the market kind of desk.

And if you want to talk about kind of where we're seeing product usage and more particularly I think.

You hit it on the head of hit that Theres variability right, you've got some accounts using it more than the others, but what's nice is we're the first company to launch the entire range at one time the Halo framework for the technology is resonating. The fact that we are the most natural lease modified Colorado acid allows the practices to have a nice story for consumers.

Dustin S. Sjuts: But what's nice is, while we're the first company to launch an entire range at one time, the halo framework for the technology is responding. The fact that we are the most natural, least modified ponderonic acid allows the practices to have a nice story for consumers. I'd say they're deciding what fits their practice best, whether it's two, three, or four. And then once they get started with that, we've got an opportunity. to expand. So I really think it varies based on the needs of the practice, but we haven't found a situation where, you know, it just doesn't fit.

I'd say, they're deciding what is it's the practice password, whether it's two three or four and then once they get started with that we've gotten the opportunity to expand so I really think of it varies based off of the in each of the practice, but we haven't found the situation where.

It just doesn't fit theres opportunities for us to continue to grow and even build on the foundation that we've started so far.

Mark J. Foley: There are opportunities for us to continue to grow and even build on the foundation that we've started. And in terms of the headwinds and opportunities for Daxi, I mean, you know, we're going up against some formidable competitors who have longstanding relationships in the business. But again, I think we've stated our strategy. We're coming at it with leading products and services. We're going to be exclusive.

And in terms of the the headwinds and opportunity for taxi.

We're going up against some formidable competitors, who have long standing relationships in the business, but again I think we've stated our strategy, we're coming at it with leading products and services, we're going to be exclusive we're going to deal with leading practices. So.

Mark J. Foley: We're going to deal with leading practices. So, you know, we expect that we'll continue to see our competitors try and create incentives for customers to put a lot of product on the shelf to make it harder to pull our product. to lean in heavily with DTC efforts to drive more consumer awareness and demand. But, at the end of the day, I think that, you know, our strategy is different.

We expect that we'll continue to see our competitors.

Try and create incentives for customers to put a lot of product on the shelf to make it harder to pull our products the lean and heavily with DTC efforts to drive more consumer awareness and demand.

But at the end of the day I think that our strategy is different and it's going to resonate with some customers.

Mark J. Foley: And it's going to resonate with some customers and not all, but again, we're not trying to be everything to everybody either. And so, you know, we're encouraged by the traction we're seeing. I would also say that, you know, we're also seeing a return to sort of normal volumes, and this is a very healthy market. And so, at some level, we're all winning in the marketplace out there. Procedures are growing. More consumers are engaging, so kind of everybody's benefiting from that lift too. And so it's not necessarily just a zero-sum game either.

And and not all but again, we're not trying to be everything to everybody either and so we're encouraged by the traction we're seeing I would also say that we're we're also seeing a return to sort of normal volumes and this is a very healthy market and so at some level. We're all winning in the marketplace out there procedures are growing more consumers are engaged.

Aging so kind of everybody is benefiting from the lift two and so it's not necessarily just the zero sum game either.

Operator: Thanks, thanks, Jim. Next question.

Thanks, Jim next question.

Operator: Thank you. Your next question comes from the light of

Thank you and your next question comes from the line of Terence Flynn from Goldman Sachs. Your line is now open.

Operator: from the line of Terrence Flynn from Coldman Sachs. Your line is now open. Great. Thanks so much for taking the questions.

Great. Thanks, so much for taking the questions.

Unknown Attendee: Great. Thanks so much for taking the questions.

I was just wondering.

Unknown Attendee: I was just wondering, maybe if you could comment or speculate with respect to the timing of the manufacturing inspection, if you think that might occur this year. And then, you know, just broader, as you think about the recovery here and aesthetics, maybe you guys could tell us what you're seeing out there in the marketplace, maybe March trends versus earlier in the quarter. And then any update on how you're thinking about the international opportunity for you, for Daxi.

And maybe if you could comment or speculate with respect to the timing of of the manufacturing inspection. If you think that might occur this year and.

And then just broader as you think about the recovery here in aesthetics, maybe you guys could could tell us what youre seeing out there and the marketplace maybe march trends versus earlier in the quarter and then any update on how youre thinking about the international opportunity for <unk>. Thank you.

Mark J. Foley: Thank you. Sure, thanks, Terence. So first off, the inspection timing, you know, again, we continue to expect that we'll be approved and on the market before the end of 2021. As I mentioned in my prepared remarks, you know, we do expect that we'll receive an inspection date in the not too distant future. Again, if you look at, you know, the COVID numbers are trending down, certainly in the Northern California area where a manufacturing facility is, you know, the agency just recently last week put out stated guidance, which is their most comprehensive to date in terms of their stated goals about how they're going to approach things.

Sure. Thanks parents parents, so first off the inspection timing and we continue to expect that will be approved and on the market where at the end of 2021 as I mentioned in my prepared remarks, we do expect debt will receive and inspection date, and then and the not too distant future.

Again, if you look at.

The COVID-19 numbers are trending down and certainly in the northern California area, where our manufacturing facility as the agency just recently last week put out updated guidance, which is the most comprehensive to date in terms of their stated goals about how they're going to approach things and based on our ongoing engagement with the agency and.

Mark J. Foley: And, you know, based on our ongoing engagement with the agency and, you know, leveraging other resources, we continue to feel that we will be provided with an inspection date again in the not-too-distant future. And while typically we wouldn't be making these comments, given the unique COVID environment, we will announce publicly once we get a date from the agency. So we'll have that to be able to share.

And leveraging other resources, we continue to feel that the.

We will be provided with and inspection date, again, and the not too distant future and well.

Well typically we wouldn't be making these comments given the unique COVID-19 environment, we will announce.

Publicly once we get the date from the agency.

We'll have that to be able to share and then.

Mark J. Foley: And then, you know, maybe I'll let Dustin talk a little bit about sort of the recovery trends and what we're seeing there. Yeah, I think overall trends in the aesthetic industry are always a bit complex, right? You've got seasonality from Q1 to Q4. You've got different pricing programs or loyalty discount programs that drive certain purchase behaviors. And so it's a bit complex to trend out. And then layer on top of the COVID environment, it makes it even more complex.

Maybe I'll, let dust and talk a little bit about sort of the recovery trends and what we're seeing there yeah, I think overall trends and the aesthetic and industry are always a bit complex right. You've got seasonality from Q1 to Q4, you've got different pricing programs or loyalty discount programs that drive certain purchase behaviors and so it's a bit of complex the trend.

And then layer on top of the COVID-19 environment. It makes it even more complex however, as it looks to the recovery looking at how well the market is trending I think youre seeing that we've reported volumes are up from a processing volume. So that speaks of the health of the overall practice.

Dustin S. Sjuts: However, as it looks to the recovery, looking at how well the market's trending, I think you're seeing that we've reported volumes that are up from our processing volumes. So that speaks to the health of the overall practice. Leveraging that data, we can see that practices are growing, not just in injectables. We talked about more live meetings. We went to the first live meeting in Miami that was held.

Leveraging that data we can see the practices are growing not just and injectables.

We've talked about more live meetings, we went to the first live meeting in Miami.

That was held so a lot of education has begun the gun again as well as travelling and Youre starting to see increase in travel and so we feel like we're in a real good position for the recovery of the aesthetic market today.

Dustin S. Sjuts: So live education has begun again, as well as travel. You're starting to see an increase in travel. So we feel like we're in a really good position for the recovery of the aesthetic market. And then on the international opportunity, you know, we clearly think that the value story in the U.S. will play internationally as well. So we believe that this is a product that we can take into all international markets and drive, you know, real value and pick up sort of our fair share of the market.

And then on the international opportunity, we clearly think that the <unk>.

<unk> story and the U S will play internationally as well. So we believe that this is a product that we can take into all international markets and drive real value and pick up sort of our fair share of the market, having said that given the size of the U S market, the favorable pricing dynamics and our focus with the <unk>.

Dustin S. Sjuts: Having said that, given the size of the U.S. market, the favorable pricing dynamics, and, you know, our focus with the RHA fillers and the HINMD platform, we really feel that it's the best return for us right now to focus our efforts in North America.

And hidden in the platform.

And really feel that it's the best return for US right now to focus our efforts in North America.

Mark J. Foley: You know, going forward, we'll get more context in color because we certainly do plan to expand in other markets. Obviously, with our partnership with FOSIN, we're heading down that path toward China. Canada's an obvious one for us, given the, you know, contiguous nature and sharing of KOLs with the U.S.

Going forward, and we'll give more context and color because we certainly do plan to expand and other markets, obviously with our partnership with Bose and we're heading down that path towards China.

And obviously and obvious one for us given the contiguous nature and.

And sharing of Kols with with the U S. But we will provide more of a comprehensive update later in the year early next year with regards to the international plans, we do expense to do plan to go global overtime.

Mark J. Foley: But we'll provide more of a comprehensive update later in the year, early next year, with regard to international plans. We do intend to go global over time. Next question. Thank you. And your next question comes from the line of Annabon Sunini from Cepo. Your line is now open. Hi, thanks for taking my question. I had a few.

Next question.

Thank you and your next question comes from the line of kind of <unk> from Stifel. Your line is now open.

Hi, Thanks for taking my question and I had a few.

Operator: First on RHA, Siller, is there anything you can share in terms of reordering patterns? You gave us a nice outline of the various buckets of clients, but within those, do you have a reordering rate? On market growth that you commented on earlier, you know, in the market opening up and travel starting to sort of come back, I guess there's some commentary that there is extra disposable income because people are traveling less. Do you think this might have any impact going forward on demand in the aesthetics market?

First on the RSA pillar of this or anything you can share in terms of the reordering patterns you gave us the nice outline of the various buckets of claim.

And but within the.

Do you have of reordering rates.

And on market growth and you commented on earlier.

You know and the market opening up and travel starting to sort of come back I guess, there's the there's some commentary that there was extra of disposable income.

And people are traveling less do you. How do you think this might have any impact going forward on on demand and the aesthetics market and then finally, if we can talk a little bit about the therapeutic side NAV.

Operator: And then finally, if we can talk a little bit about the therapeutic side, you know, after the data in cervical dystonia and upper limb spasticity, it seems to be that the safest areas for study are areas in which neuromodulators have already been validated. So, you know, I guess. Does that lend any thoughts as to what your next move is here? Are you going to still explore any new avenues of study, or are you going to stick with the areas where neuromodulators have been validated and anything to update on new programs there? Yeah, thanks, Annabelle. We'll try and tick these off in order.

And after the data and cervical dystonia and upper limb spasticity it seems.

And at the safest area of study or errors and wished neuromodulators have already.

And validated so.

I guess.

Does that lend any thoughts as to what your next move is here.

And still explore any new avenues of of study or are you going to stick with the areas where and neuromodulators.

And had been validated and anything.

The update on new programs there.

Yeah. Thanks, Annabel, we'll try and kick these off and order so on the filler side. It's just it's still a little early for us to provide context to the reorder rates because.

Unknown Attendee: So on the RHA filler side, it's still a little early for us to provide context to the reorder rates because, you know, when they started on board, how they purchased it, you know, some lean in early, some kind of use it, and then want to see a little bit before they make their decision. So it's early. Clearly, with the growth we're seeing in Q1, which is historically, you know, a seasonally slower quarter, we're encouraged.

When they started on board how they purchase debt.

Some lean and early some kind of use it and then want to see a little bit before they make their decision. So it's early clearly with the the.

The growth we're seeing.

In Q1, which is historically a seasonally slower quarter were encouraged.

Unknown Attendee: And as we feel like we've got a good handle on that, we'll be happy to share it, but I think it's just still a little bit too early for that. In terms of market growth, I think, as Dustin mentioned, we're seeing good healthy trends overall for sure. And I think, you know, some of our competitors are reporting a very healthy market as well. You know, certainly extra disposable income isn't going to hurt that and would certainly be a tail win.

And as we feel like we've got a good handle on that information, we'll be happy to share and I think it's just still a little bit too early for that.

In terms of the market growth I think of Dustin mentioned, we're seeing good healthy trends overall for sure and I think some of our competitors are reporting very healthy market as well.

Certainly extra disposable income and hurt that and would certainly be a tailwind, but if you think about it we're much more focused on a select part of the market. We're going after these higher and prestige practices and they are probably a little less susceptible to.

Mark J. Foley: But if you think about it, we're much more focused on a select part of the market. We're going after these higher-end, you know, prestige practices. And they're probably a little less susceptible to, you know, disposable income. But it, you know, clearly, there's a very healthy trend right now in the aesthetics market. There still are a few pockets that are a little slower than others that are taking a little longer to open up where, you know, certainly, for example, like New York City, a lot of people sort of got out of the city.

Disposable income.

But clearly there is a very healthy trend right now and the aesthetics market. There still are a few pockets that are a little slower than others that are taking a little longer to open up. We're certainly for example, like New York City of lot of people sort of got out of the city.

Mark J. Foley: But we expect that those will also start to rebound in a healthy way as we kind of move into the middle part of the year. But, again, based on the accounts that we're calling on, we're seeing, you know, very healthy procedure volumes. And then the last one on the therapeutic side of it, you know, given the planter fasciitis results where we saw an encouraging trend but not a statistical difference in terms of the improvement in pain there, we sort of huddle back up.

But we expect that those will also start to rebound and a healthy way as we kind of move into the middle part of the year, but.

And so again based on the accounts that we're calling on and we're seeing very healthy procedure volumes. There and then last one on the other therapeutics side of it.

Given the.

And the plantar fasciitis results, where we saw an encouraging trend, but not of statistical difference in terms of the <unk>.

Improvement in pain, and there we sort of huddle back up and we think our best return is to go after those indications where there is already an established market the duration benefit that our product offers is pretty clear and and those markets. There is also significant pharma go economic savings. So we're in CD.

Mark J. Foley: And we think our best return is to go after those indications where there's already an established market. You know, the duration benefit that our product offers is pretty clear. And in those markets, there are also significant pharmacoeconomic savings. So, you know, we're in CD, adult upper limb spasticity. Obviously, we've historically talked about migraine due to its size, something that it's not an if, it's a when. But I think our approach right now is going to be more focused on, you know, those established market indications. Obviously, as we mature in that market, you know, we might evaluate some other alternatives. But right now, that's where our focus is.

Adult upper limb spasticity, obviously, we've historically talked about migraine due to the size is something that.

If it's a win but I think our approach right now is going to be more focused on.

Those established market indications, obviously, as we mature and that market, we might evaluate some other alternatives right now that's where our focus is.

Mark J. Foley: Great, thank you. Great, thanks, Annabelle. Thank you, and again, to ask a question, please press Star 1 on your phone's keypad. We would also like to ask for a limit of one question and one follow-up question per session. Your next question comes from the line of Pallaji Prasad from Bark.

Okay, great. Thank you.

Great. Thanks Annabel.

Thank you and again to ask the question. Please press star one on your thoughts keypad and I'd also like to ask for a limit of one question and one follow up question for the session.

Our next question comes from the line of <unk> Prasad from Barclays. Your line is now open.

Operator: from Barclays: your line is now open. Hi, good afternoon, thanks for the questions. So, firstly, on biosimilar Botox, your partner commented this morning that they submitted the FDA data package. What does this mean in terms of submission timelines and any updated thoughts around there? And on the same topic, it's been a while since we had an update on the topical biosimilor program. So what steps are needed to be done before you can consider moving that to phase one? Thank you.

Hi, good afternoon, and thanks for the questions.

And so firstly on the Biosimilar botox.

And so your partner of commented this morning debt, that's something to the FDA data package. What does this mean in terms of submission timelines on any updated thoughts around there and.

And on the same topic.

It's been a while since we had and update on the topical Biosimilar program.

Topical program. So what steps are needed to be done before you can kind of stumbling debt the phase one and thank you.

Unknown Attendee: Thanks, Blasch. Maybe I'll take the second one first and then ask Obai to comment on the biosimilar program. But on the topical side of it, you know, we've really focused our efforts on the injectable formulation because that's where, you know, we have the clinical data to support it, you know, a healthy, differentiated product profile. And so we're leaning in on that. Obviously, with all the work that we did in the topical program, that is something that, you know, we may go back and revisit as we go forward.

Thanks philosophy of maybe I'll take the second one first and then ask all by the comment on the Biosimilar program, but on the the.

The topical side of it and we've really focused our efforts on the injectable formulation because thats where.

We've got the clinical data to support it.

And the differentiated product profile and so we're leaning in on that obviously with all of the work that we did and the topical program that is something that we may go back and revisit as we go forward.

Unknown Attendee: But, you know, right now, our primary focus is on, you know, dactylotulinum toxin A for injection. So, if and when we lean into that a little bit more, we'll certainly come back to the investor community on Friday to provide an update. And then, Avai, you want to take the biosimilar question? Yeah, so, Balaji, since our last initial bioadverse meeting with the FDA, we continue to make progress with great cooperation from our partner, Waitress.

But right now our primary focus is on.

Back to the botulinum toxin day for injection.

So if and when we lean into that a little bit more and we will certainly come back to the investor community and Friday and provide an update and then of how you want to take the at the Biosimilar question, Yes.

Yes, so <unk> since our last of initial buy adversity of meeting with the FDA.

To make progress and with great cooperation from our partner of interest.

Unknown Attendee: We are making study progress towards the biochemical characterization work and have adequate data to share with the FDA. And with the filing of the briefing book, our focus is on seeking agreement on the Phase 3 study. After our meeting with the FDA, we'll be in a position to assess more in terms of timings for R&D and the

Making steady progress towards the biochemical characterization work and of adequate data to share with the FDA and with the.

Filing of the briefing book, our focus is on seeking the agreement on the Phase III program.

And after our meeting with the FDA it could be.

And to assess more in terms of timings for the R&D and upwards.

Mark J. Foley: Great, thanks. If we could just have a follow-up on RHA-1. So you gave expectations around getting an approval in H-2. So realistically, could we see a launch at the end of this year with RHA-1-2?

Great. Thanks, if I could just kind of follow up on auto channel one.

So you can go and expectations around getting and a per lowly niche too. So realistically could we see and launch of the end of the Sierra with IHL and too.

Mark J. Foley: Yeah, so Teoxi and our partner have already filed the submission on the RHA1. Again, we don't control sort of that process. You know, they're the ones that drive the regulatory process.

Yes, so to say and our partner has already filed the submission on the RAC of one again, we don't control sort of that process there the.

One's that drive that the regulatory process, but based on that filing and the timeline. We've indicated that we would expect and approval sometime in the second half assuming ever.

Mark J. Foley: But based on that filing and the timeline, we've indicated that we would expect an approval sometime in the second half, assuming, you know, everything's straightforward there. And so that's what we're planning for, an approval and introduction in the second half of this year. Great, thanks, Mark. Okay, thanks so much for Lach. Thank you. Your next question comes from the line of Team Ludo. From William Blair: Your line is now open.

Everything is straightforward there and so that's what we're planning for would be and approval and introduction and the second half of this year.

Great. Thanks, Mark.

Okay.

Thank you and your next question comes from the line of Tim Lugo from William Blair. Your line is now open.

Operator: Thanks for taking the question. Congratulations on all the progress in a difficult macro environment.

Thanks for taking my question and congratulations and all of the <unk>.

You know kind of a difficult macro environment.

Which is hopefully improving.

Unknown Attendee: which is hopefully improving. And thank you for talking about communicating with the street about the inspection date. So once you share the date with us, I guess how long it will take from that.

<unk>.

And thank you for talking about communicating with the street about the <unk>.

Specs and date. So one can you share of the day with US I guess, how long from the date of inspection. If it is clean and do you expect the FDA action is there any sense, you're getting from your interactions with the agency of goods.

Unknown Attendee: I guess how long from that date of inspection, if it is clean, do you expect FDA action? Is there any sense you're getting from your interactions at the agency? Is it roughly weeks?

Roughly week for the month.

Mark J. Foley: Yes, Tim, on that, I think, as we said, we typically wouldn't be commenting on this, but given the unique environment, to your point, we thought it was appropriate to level set everybody on that. So I don't know that it's appropriate to be getting into speculating about kind of timeframes, you know, post-inspection and everything else. Again, we are prepared. We're ready to support an inspection, as we stated. You know, we were hoping that we'd get an inspection date in the not too distant future, and once we do, we'll communicate that.

Yeah, So Tim on that I think.

As we said, we typically wouldn't be commenting on this given the unique environment to your point, we thought it was appropriate to level set everybody on that so I don't I don't know that it's appropriate to be getting and the speculating kind of timeframes.

Post inspection and everything else.

Again, we are prepared we are ready to support and inspection as we stated we would we're hoping that we'll get and inspection data and not too distant future and once we do we'll communicate that and then the process will take its of course from there.

Mark J. Foley: And then, you know, the process will take. It'll take off from there. Okay, understood. And, you know, given the HintmD product offering, are you able to see or what kind of rough penetration you're getting right now in the accounts with your feather line? You kind of gave us the buckets early.

Okay understood and.

And given the 10.

The product offering.

Are you able to see or what's kind of the rough kind of trace and youre getting right now and the accounts with your with your filler line.

You kind of gave us the buckets earlier and it seemed like maybe the second bucket.

Mark J. Foley: earlier and seemed like maybe the second bucket of those who are using RHA and happy with it and kind of waiting.

Those who are using our IHA and happy with it and kind of waiting for the neuromodulator too.

Unknown Attendee: for the neuromodulator to come so they don't have issues with their

So they don't have issues with their bundle.

Unknown Attendee: They don't have issues with their bundle; seems like those would be people that kind of rapidly increase their use of both products once available. Yeah, well, I think

Seems like those would be people the.

Kind of rapidly increase their youth.

Both products once available.

Mark J. Foley: Yeah, well, I think with the HintMD system, it's still early to recognize that there's not 100% overlap between our HintMD accounts and our Filler accounts. So we're in a subset of our filler accounts with the HintMD platform. And again, it's still early to kind of talk about trends and market share and everything, given that we have a wide range. And some people are still working their way through their processes of trying to figure out where it does fit in the practice.

Yeah, well I think with the hint MD system. Its still early recognize that there is not 100% overlap between our MD accounts and our filler accounts. So we're in a subset of our filler accounts with the hint MD platform and again, it's still early to kind of talk about trends and market share and everything given that we've got.

A wide range and some people are still working their way through their process of trying to figure out where it does fit in and the practice. So I think as we get more towards the back part of the year, we will have the <unk>.

Mark J. Foley: So I think as we get, you know, more towards the back part of the year, we'll have, you know, better metrics and more data that will help sort of inform our view on this and what we're comfortable sharing.

Better metrics and more data that will help sort of inform our view on this and what we're comfortable sharing.

Operator: Thank you. Your next question comes from the line of T with Am Solon from Piper Sandler. Your line is no.

Alright, thank you.

Alright, Thanks, Tim.

Thank you. Your next question comes from the line of David <unk> from Piper Sandler. Your line is now open.

Unknown Attendee: Hey, thanks. So, on the RHA, 2, 3, and 4, and I apologize if I miss this in your prepared remarks or other questions, you just talk about which of the SKUs you're seeing the greatest amount of usage and just talk about whether there is any sort of one that predominates or has, you know, gotten out of the gate the fastest. So that's number one. And then number two is on RHA1. I don't know you talked about it being filed and the potential approval. I guess what you think RHA1 adds to the overall portfolio and specifically where does it make the franchise more competitive, or what?

I think so.

On the RSA, two three and four and I apologize if I missed this in your prepared remarks of other question can you just talk about.

Which of the Skus you are seeing the the greatest amount of usage and just talk about is there any sort of one debt predominates or has gotten out of the gate the fastest.

So that's number one and then number two is on the <unk> one.

And you talked about it being filed and the potential approval I guess what are you.

I think our HLA one ads.

To the overall portfolio and specifically where does it make the franchise more competitive.

Unknown Attendee: competitor products are the most analogous to in terms of where you

Or what.

Petitor products as the most analogous to in terms of.

Unknown Attendee: is the most analogous to in terms of where you think it can gain a footprint, a foothold, if you will. Thanks, David.

Where do you think it can gain.

Our footprint of foothold if you will.

Thanks, David.

Mark J. Foley: I'll maybe provide a couple of framing comments and ask Dustin to add a little bit of additional color. In terms of the mix of the products, we did not cover that in the prepared remarks, but it's relatively evenly split between all of them. And again, what's interesting is you don't find a consistent pattern where all accounts use the same amount. You know, some people will say, I like three for this area, or I like two for this area. And, you know, it can vary based on kind of how the practice approaches things, you know, what look they're going for. You know, their mix of patients, are they younger, are they older.

Maybe provide a couple of framing comments and that stuff and to add a little bit of additional color in terms of the mix of the products. We did not cover that in the prepared remarks, but it's relatively evenly split between all of them and again. What's interesting is you don't find consistent pattern, where all accounts use the same amount some people will say.

And I like free for this area or two for this area and.

It can vary based on kind of how the practice of.

Approaches things, what look theyre going for.

The mix of patients or the younger and the older and so right now it's pretty evenly split overtime I would imagine that will separate a little bit.

Mark J. Foley: And so right now, it's pretty evenly split over time. I would imagine that that will separate a little bit. You know, RHA4 being sort of the heaviest of the gels is used deeper. And so in cases, you sometimes see that when it's used, there's more volume that's used, whereas two being a little more superficial.

RJ or being sort of the the heaviest of the gels is deeper and so and cases.

Sometimes see that when used theres more volume that's used for is to being a little more superficial.

Mark J. Foley: It's a really nice product in that it moves very naturally and maybe not as much on a per patient basis but might have, you know, sort of broader adoption on that. And then on the RHA side of things, it's for, you know, sort of peri-oral lines. So, sort of fine lines, very superficial.

A really nice product and that it moves here and nationally and and maybe not as much on a per patient, but might have sort of broader adoption on that.

And then on the RH and one side of things.

It will be a smaller market, it's for sort of <unk> oral lines, and so sort of fine lines very superficial, but but there's not really another product out there right now that is as unique as it is and so while it will be a smaller part of the market. It is a differentiated offering that will certainly I think enhance the the different.

Mark J. Foley: But there's not really another product out there right now that is as unique as it is. And so while it will be a smaller part of the market, it's a differentiated offering that will certainly, I think, enhance the different products that we can offer. And frankly, we'll give them a foot in the door too for some accounts where, you know, if they don't feel like the two, three, and four, give them something that they can't do today. It will do that.

So that we can offer and frankly will give us a put and the door too for some accounts, where if they don't feel like the two three and four give them something that they can't do today, and we'll do that and I don't know adjusted if you want to add color on what's closest to our each day, one and then any other insights from two three and four.

Dustin S. Sjuts: And I don't know, Justin, if you want to add color on, you know, what's closest to RHA1 and then any other insights on two, three, and four. You know, I think you hit it pretty well on two, three, and four. I think that's the uniqueness of launching them all at once.

You hit it pretty well and there are two three and four I think thats the uniqueness of launching them all at once the allows us to create an opportunity for practice to utilize what fits best for them versus taking one product and kind of trying to get them to shove. It down you have to use the process. So I do think over time four will likely be the the larger of product just based off of pure volume, but we've been very.

Dustin S. Sjuts: It allows us to create an opportunity for practice to utilize what fits best for them, versus taking one product and kind of trying to get them to shove it down. You have to use this product. So I do think, over time, four will likely be the larger product just based on pure volume. But we've been very happy with how three and two have held up as well.

Happy with how free into have held up as well on the IHA one is a bit unique.

Dustin S. Sjuts: An RHA1, it's a bit unique. It has the same technology platform as RHAs two, three, and four, being the least modified and most natural. It also has the lowest amount of cross-linked RHA, the lowest concentration, which allows the product to be used a bit more superficially than anything that's on the market today. That's what we're hearing from some of our colleagues in Europe. while it will be indicated in the United States for parallel wines, specifically, there are other areas in which it's being utilized as well.

Has the same technology platform as R. J, two three and four being the least modified most natural and also has the lowest.

The amount of cross linked RJ lowest concentration, which allows the product to be used a bit more superficial than anything in from the market today and that's what we're hearing from some of our colleagues and Europe, while it will be indicated and the United States repair or wine, specifically theres other areas and which is being utilized as well. So it should be a nice complementary addition to Mark's point that the low.

Dustin S. Sjuts: So it should be a nice complementary addition to Mark's point that with the lower volume product, you're not going to use multiple syringes of that type of product. And so it will just add that rounding out, and it also stands alone as something that isn't available today. What they use for some of those products, or the main one would probably be Bobela, is where they're probably using the most superficial products, and then some other products.

Sure volume products Youre, not going to use multiple syringes of that type of product and so it will just add that rounding out and it also stands alone is something that isn't kind of available today and what they use for some of those products of the main one would probably flow Bella is where it's probably they are using the most superficial products and then some other products like military and other.

Dustin S. Sjuts: like Velatero and others, I believe, are using in some of those superficial areas as well, too. But we feel like it'll add a nice halo, as well as leverage what is currently responding to an innovative technology platform being least modified. Okay, that's helpful. Thank you. Prick. Thanks, David.

And I believe we're using and some of the superficial areas as well too, but we feel like it'll add.

A nice halo as well as being of the leverage what is currently resonating and innovative technology platform being leased modified.

Okay. That's helpful. Thank you.

Great. Thanks, David.

Operator: Thank you, and your next question comes from the line of Jacob Hughes from Wells Fargo Securities. Your line is now open. Hi, good afternoon.

Sure.

Thank you and your next question comes from the line of Jacob Hughes from Wells Fargo Securities. Your line is now open.

<unk>.

Hi, good afternoon, and thanks for taking my question Mark just the.

Unknown Attendee: Thanks for taking my question. Mark, just elegant aesthetics announced a deal today to add to their offering. Are there any additional areas you're looking to add on an inorganic basis over the next 12 months? And then, you know, thank you very much for the additional disclosure on the inspection. Based on your interactions with FDA, has there been any additional feedback on a potential label? Thanks very much.

Elegant of aesthetics to announce the deal today to add to their offering is there any additional areas youre looking to add to and Ah.

Panic basis over the next 12 months and then.

Thank you very much for the additional disclosure on the inspection.

Based on your interactions with FDA has the has there been any additional feedback on the potential label. Thanks very much.

Mark J. Foley: Sure, thanks, Jacob. So first, you know, in terms of other areas, you know, if you go back a little over a year, we were just a neuromodulator company, right? And so, you know, we recognize that to effectively compete in the facial injectable market, having a leading filler and a services offering, which we acquired in NMD, was going to be critical to advancing this prestige strategy. Also, when we look at the overall facial injectable market, that's a sales force that's the same sales force that sells all those products.

Sure. Thanks, Jacob So first and.

In terms of other areas.

And you go back a little over a year, we were just neuromodulator company right and so we recognize that to effectively compete and the facial injectable market that having a leading filler and a services offering which we acquired in and indeed was going to be critical to advancing this prestige strategy.

And when we look at the overall facial injectable market.

The <unk>.

Sales force.

The same sales force that sells all of those products as soon as you start moving into other areas skincare brass devices Youre talking about of different sales force. So I think we feel right now we've got the right assets to compete we really liked the facial injectable category. These are built.

Mark J. Foley: As soon as you start moving into other areas, skincare, breasts, devices, you're talking about a different sales force. So I think we feel right now we've got the right assets to compete. We really like the facial injectable category. These are, you know, billion dollar plus categories in the filler area and in the neuromodulator area in the U.S. alone. And so, you know, we feel we've got enough on our plate right now to focus and execute.

Billion.

The categories and the filler area and and the Neuromodulator area and the U S alone.

And so we feel we've got enough on our plate right now to focus and execute and this year will be.

Mark J. Foley: And this year will be, you know, very important that we execute well. And certainly, over time, we'll continue to be open-minded if we think that, you know, there are different products that would further advance what we're trying to build here. But for now, we sort of like how we're positioned in the facial injectable category. And then, the second one, in terms of, you know, FDA and any kind of, you know, feedback on that side of it, we continue to feel good about the discussions.

Very important that we execute well certainly over time, we will continue to be open minded if we think that.

And theres different products that would further advance what we're trying to build here, but for now we sort of like how we're positioned in the facial injectable category.

And then the second one in terms of FDA and any kind of feedback on that side of it.

We continue to feel good with the discussions I'd point, you back to our scripted comments, where we are hopeful that we'll get and inspection date, and the not too distant future and that will be able to.

Mark J. Foley: I point you back to our scripted comments where, you know, we are hopeful that we'll get an inspection date in the not too distant future and that we'll be able to, you know, turn that around and get the product on the market, you know, shortly thereafter.

Turn that around and get the product on the market shortly thereafter.

Okay got it and if they get any of that.

Mark J. Foley: Okay, I got it. And if they get any of the label, I missed it.

Of the Lake.

And I missed it yeah, so on the label.

Mark J. Foley: Yeah, so on the label. When we announced that we were not going to get approved on our Purdue date of November 25th, what we basically stated was that, you know, everything else had already been worked through with the agency, CMC, clinical, pre-clinical, and that the only outstanding item at that point was, you know, the on-site physical inspection as part of the PAI. So, you know, that's the last piece that we need to complete in order to get the product approved. And so, by default, you know, we feel good about where we are with all the other people. Thanks, Mark. Congratulations on your progress.

Yes.

And we.

The announced that we were not going to get approved on or produce the date of November 25th what we basically stated was that.

Everything else had already been.

Worked through with the agency CMC clinical and preclinical and at the only outstanding item at that point was.

The onsite physical inspection as part of the P. AI so.

The last piece that we need to complete in order to get the product approved and so by default we feel good about.

And where we are with all of the other pieces.

Most of our congrats on the progress.

Operator: Thank you, and to ask a question, you will need to press Star 1 on your phone's keypad. Your next question comes from the line of Vamil Divan from Missoujo. Securities, your line is now open. Great, thanks for taking my questions. Maybe just a follow-up on a couple topics to touch on. One, I guess, would be the migraine opportunity on the therapeutic side. I know sometimes you guys have been saying it's a matter of when you pursue that as opposed to if you can pursue it.

Right. Thanks Jacob.

Yeah.

Thank you and to ask the question you will need to press star one on their phones keypad.

Your next question comes from the line of venue of the ban from Mizuho Securities. Your line is now open.

Great. Thanks for taking my question. So maybe just a follow up on a couple of topics you guys touched on one I guess would be the migraine opportunity of the therapeutic side I know for some time that you guys have been saying, it's sort of a matter of when.

Your pursuit of that as opposed to if you can pursue it I guess I'm just sort of wondering what.

Operator: I guess I'm just sort of wondering what you're waiting for. It's obviously a pretty large market, but also competitive, and maybe more competitors coming. So I think you'd want to get to the market sooner than later, so just maybe you can share your thoughts on as you're thinking about that opportunity. And then the other one, just maybe more as you're thinking about DAXI and sort of the go-to-market strategy, especially around pricing. I'm just curious if there's anything new or different in how you're thinking about it.

Youre waiting for what's going and just make the decision to move forward is obviously pretty large market.

But also of competitive and maybe more competitors coming so I think you'd want to get to the market sooner than later. So just maybe you can share your thoughts on and as you think.

And you about that opportunity and and the other one just maybe.

Or as you're thinking about the taxi and sort of the go to market strategy, especially on pricing I'm. Just curious if there's anything new or different and how youre thinking of I know you've talked about potentially getting a premium product to maybe be a premium price, maybe anything north or you could share there.

Unknown Attendee: I know you've talked about potential premium products and maybe it'd be a premium price. Maybe there's anything more you could share there, given others who've been delayed a little bit, but there's also a very evolving economic backdrop that you'd be launching into. So any updated thoughts there would be helpful. Thank you.

And all of this had been delayed a little bit but is also a very evolving economic backdrop that you've been launching and two so any updated thoughts there would be helpful. Thank you.

Yeah. Thanks, it's almost the first on the on migraine, if you wind back the clock a little over a year ago, and we didn't have any products and the market. We were supporting three different clinical trials independent of our aesthetics and the therapeutic side with the plantar fasciitis cervical dystonia upper limb spasticity, So frankly was a little bit of our capital allocation.

Mark J. Foley: Sure. Yeah, thanks. So first on migraines, you know, if you wind back the clock a little over a year ago, we didn't have any products in the market. We were supporting, you know, three different clinical trials, independent of our aesthetics and the therapeutic side with planar fasciitis, cervical, lestonia, and upper limb spasticity. So, frankly, it was a little bit of a capital allocation and where we were with these different things. And so we had to make choices about where we thought we could generate the best return. And so that was really the biggest influencer.

And where we were with these different things and so we had to make choices about where we thought we could generate the best return.

And so that was really the biggest influencer we share your view of that certainly the migraine market is very large and size and therefore, the sooner you get going and as soon as you kind of lock it but it was really more of a capital allocation decision and so for this year given the launch of our aesthetics franchise and the importance of getting that right. We said you know migraine is not something that were.

Mark J. Foley: Or, we share your view that the migraine market is very large in size. And therefore, the sooner you get going, the sooner you kind of lock it in, but it was really more of a capital allocation decision. And so for this year, given the launch of our aesthetics franchise and the importance of getting that right, we said, you know, migraine is not something that we're going to advance this year. And that it's, you know, not an if, it's a win.

And to advance this year and that it's.

Not and if it's a win and so obviously that's going to be one of the key areas that gets discussed as we kind of move into the planning cycle for 2022.

And we'll also get the benefit of our neuromodulator product being in the market and getting some feedback on overall performance. There. So I think thats something that will help us as well so stay tuned on that we do like our.

Mark J. Foley: And so, you know, obviously, that's going to be one of the key areas that gets discussed as we kind of move into the planning cycle for 2022. We'll also get the benefit of, you know, our neuromodulator product being in the market and getting, you know, some feedback on, you know, overall performance there. So I think that's something that will help us as well. So stay tuned on that.

Reputed franchise is now starting to come into view, we are starting to move out of that clinical phase and are focused on commercial. So we're excited that we think will finally be able to start getting.

Some some traction and credit for the investments that we've made there.

On the DAC the pricing nothing really new there we've historically talked about the fact, we've invested hundreds of millions of dollars to bring true innovation into this category and as a result.

Mark J. Foley: We do like, you know, our therapeutics franchise is now starting to come into view. We're starting to move out of that clinical phase and are focused on commercials. So we're excited that we think we'll finally be able to start getting, you know, some traction and credit for the investments that we've made there.

Just on the duration profile and our market research, we believe that we can charge a premium or physicians will pay a premium and they can charge there.

The consumers of premium two and that everybody wins and that stack also we're not trying to be everything and everybody. Our strategy of prestige category means that it will work for some consumers and some practices and not for everybody, but we think within that overall sort of price and stack that physicians will be able to make more money consumers will pay more and that we have and ability.

Mark J. Foley: On Dacti pricing, nothing really new there, you know; we've historically talked about the fact that we've invested hundreds of millions of dollars to bring, you know, true innovation into this category. And as a result, based on the duration profile and our market research, we believe that we can charge a premium. Our positions will pay a premium, and they can charge their consumers a premium, too, so everybody wins in that stack.

Charge more than the marketed products today, so obviously more to come on the pricing details once once we launch and are and the market.

Okay. Thank you.

Alright, Thanks model.

Thank you and your next question comes from the line of cash Bill Andrews from Needham and company. Your line is now open.

Mark J. Foley: Also, we're not trying to be everything to anybody. Our strategy of the prestige category means that it'll work for some consumers and some practices and not for everybody. But we think within that overall sort of pricing stack, positions will be able to make more money, consumers will pay more, and we have an ability to charge more than the marketed products today. So obviously, more to come on the pricing details once we launch and are in the market.

Hey, good afternoon, thanks for taking my questions.

First one on the are a true fillers and Mark I know you don't want to give.

And for this product at this time, but you had a really solid quarter and what is normally a slower.

Weak seasonal quarter for the aesthetics market.

And you just give us an idea of what is the usual step down from <unk> to <unk> and aesthetic procedure volumes and whether and how.

Mark J. Foley: Thank you. And for your next question.

Operator: comes from the line of search Belanger from Needham and Company. Your line is now open. Hey, good afternoon.

And how much more depressed it was because of COVID-19 and how we should think about those revenue is going forwards.

Unknown Attendee: Thanks for taking my question. First one on the RHA fillers, Mark, I know you don't want to give guidance for this product at this time, but you had a really solid quarter in what is normally a slower, winter seasonal quarter for the aesthetics market. So you just give us an idea of what the usual step down from 4Q to 1Q in aesthetic procedure volumes and whether how much more depressed it was because of COVID and how we should think about those revenues going forward. Yeah, so on the filler side, I mean, I guess it's a little hard search because, you know, you've got some headwinds and you've got some tailwinds.

Yes, so on the filler side I mean, I guess, it's a little hard search because you've got you've got some headwinds and you've got some tailwind the tailwind. We're in launch mode right. So we have the ability to grow a little bit just by opening up new accounts at a more rapid pace given the fact that we have new products and the marketplace.

And as you pointed out the historical trends Q4 to Q1, I mean, it could be down as much as 20% from.

From an overall procedure volume standpoint, but we've also got things that are starting to open up with the pandemic. So were seeing some benefits there as well and so.

Mark J. Foley: I mean, the tailwind. We're in launch mode, right? So we have the ability to grow a little bit just by opening up new accounts, right, at a more rapid pace, given, you know, the fact that we have new products in the marketplace. You know, as you pointed out the historical trends, you know, Q4 to Q1. I mean, it can be down as much as 20%, you know, from an overall procedure volume standpoint. But we've also got things that are starting to open up with the pandemic, so we're seeing some benefits there as well. And so I just, it's hard.

It's just it's hard.

Working our way through our funnel and we're also targeting those accounts that are more amenable to leaning in and as we work our way through that and as we go towards the back part of the year.

It's possible that that gets a little harder as the.

And those folks there and then certainly once our neuromodulator comes in it's going to create yet another new opportunity for people to engage so I know, it's the big non the answer but.

We were very pleased with the performance in Q1 again, it's sort of outpaced our internal expectations. It is still early we are cautiously optimistic we would expect that given we're still and the launch base debt certainly Q1 to Q2 that revenue will be up and.

Mark J. Foley: We're obviously working our way through our funnel, and we're also targeting those accounts that are more amenable to leaning in. And as we work our way through that, and as we go towards the back part of the year, you know, it's possible that that gets a little harder as, you know, those folks there. And then certainly, what their neuromodulator comes in is going to create yet another new opportunity for people to engage.

And that will continue to drive more accounts.

Automation and that will get the benefit of the reorder rates. So.

Stay tuned and we'll again, we're happy to share of some of these metrics. Once we have confidence that we've got enough data to tease out some trends.

Mark J. Foley: So I know it's a lot of new opportunity for people to engage. So I know it's a big non-answer, but, you know, we were very pleased with the performance in Q1. Again, it's sort of outpaced our internal expectations. But it's still early.

Okay.

Just a quick one on the hit M D.

And as you expand your presence there.

Are you displacing and with the release of the Nextgen platform.

Does that change the economics at all on.

The way you can capture from the <unk>.

Mark J. Foley: We're cautiously optimistic. We would expect that given we're still in the launch phase, that certainly, you know, Q1 to Q2, revenue will be up. And that we'll continue to drive more account activations and that we'll get the benefit of the reorder rate. So, you know, stay tuned. And again, we're happy to share some of these metrics once we have confidence that we have enough data to tease out some friends. Okay. Just a quick one on HITMD.

The growing processing volumes.

Yeah. So in terms of who we're displacing I mean theres a lot of different credit card processing companies that are out there. So it's not like there is free.

Three or four and we're fighting the share battle so.

Some cases, they might have of square device that they are using or it might be a device provided by a third party credit card reseller and so I think it's the mix of who we're displacing and at some level of that helps a little bit because there's not sort of and organized large company out there that we're battling over and we have a bit of an unfair advantage.

Mark J. Foley: As you expand your presence there, what are you displacing? And with the release of the next-gen platform, does that change the economics at all on, you know, what you can capture from the growing processing volumes? Yes, so in terms of who we're displacing, I mean, there are a lot of different credit card processing companies that are out there, so it's not like there are, you know, three or four, and we're fighting the share battle. So, you know, in some cases, they might have a Square device that they're using, or it might be a device provided by a third-party credit card reseller.

And given our domain expertise because of lot of these companies sell credit card systems that go into a variety of different industries.

And they aren't necessarily specifically designed and developed for it.

Right now.

Until we launched the next version which has payment facilitator of capabilities.

And competing right now on a little bit competitive credit card pricing. So some people are saying, hey, I like where this is going if you could give me competitive pricing.

Mark J. Foley: And so I think it's a mix of who we're displacing, and at some level, that helps a little bit because there's not sort of an organized, large company out there that we're battling over, and we have a bit of an unfair advantage given our domain expertise because a lot of these companies sell credit card systems that go into a variety of different industries, and they aren't necessarily specifically designed and developed for You know, right now, until we launch the next version, which has payment facilitator capabilities, you know, we're really competing right now on a little bit competitive credit card pricing. So some people are saying, "Hey, I like where this is going." If you can give me competitive pricing, I'll be happy. to kind of get started with you.

The day to kind of get started with you.

Once we turn on the payment facilitator than we have and ability to participate and a little bit more of the credit card stack from a revenue perspective, but we also more importantly, we'll be able to turn on some functionality around.

Against subscriptions White label loyalty data analytics, and I think that's when the value of the platform will be more cleared of some of these practices. So I would expect as we move through the App part of it'll be some of the services that we start turning on and we made sort of the conscious effort not to try and do any of that until we have this next software version.

Ready to go.

Mark J. Foley: Once we turn on the payment facilitator, then, you know, we have an ability to participate in a little bit more of the credit card stack from a revenue perspective, but we also, more importantly, will be able to turn on some functionality around, again, subscriptions, what label loyalty, data analytics. And I think that's when the value of the platform will be, you know, more clear to some of these practices. So I would expect that as we move through that back part, it'll be some of these services that we start turning on.

The facilitator because.

And the current platform. It takes a lot of handholding and and we think it's just not the scalable so once the new.

Software upgrade comes and we think we'll be better positioned for that so again.

We are encouraged to get that out there and beta right now and seeing some good results.

Okay. Thank you.

Thank you and your next question comes from the line of John Chow from H C. Wainwright. Your line is now open.

Hey, everyone. Thanks for taking my question Christy all of a sudden for dog. So I just wanted to see if I could get a little bit more color on the.

Mark J. Foley: We made sort of the conscious effort not to try and do any of that until we have this next software version ready to go. That's a payment facilitator because, you know, on the current platform, it takes a lot of handholding, and we think it's just not scalable. So once this new software upgrade comes in, we think we'll be in a better position for that. So again, you know, we're encouraged to get that out there. We're in beta right now and, you know, seeing some good results.

Chinese partnership.

When you are.

Your timeline for this when do you expect a study to conclude and potential launch and as a follow up I was wondering are you just planning for.

Static indications are you also thinking about international therapeutic indications. Thanks.

And thanks for the question and I'll buy one and I turn that over to you to answer.

Mark J. Foley: Thank you, and your next question comes from the line of talk. Chao from H.C. Wainwright, your line is now open. Hey, everyone, thanks for taking my question.

Sure, Yes of Chris a great question on the on the.

First of on site.

And we are really excited about the advancement of our program into clinical collaboration.

Collaboration and two indications of global Airlines and.

Operator: Thanks for the question. Oppai, why don't I turn that over to you to answer? Sure, yes, Chris, a great question on the Fawson side.

Some of them to Sony of both the clinical trials for GL and CD run by a portion of which we support the partnership and so other will inform you of other trial completion dates and the progress as we.

Unknown Executive: We are really excited about the advancement of our program into clinicals with our collaboration on indications for Labrador Lines and cervical dystonia. Both the clinical trials for GL and CD are run by Foson, which we support the partnership for, and so we will inform you about the trial completion dates and the progress as we go along further in the clinical trials program. With regard to other indications, at this point, we only plan to initiate our program for the Global Alliance and Subcommittee Dispical Dispals.

And go along further in the clinical trials program.

The other indications at this point of the only plan to initiate our.

Program for a number of lines in cervical dystonia.

Great. Thank you.

Thanks Matthew.

And if other questions at this time I'll turn the call over back to Mike Maloney.

Thank you operator, and the coming months, we plan to virtually and the William Blair and Goldman Sachs Health care conferences. We welcome your requests for meetings that these events are directly through us.

Operator: And no further questions at this time; I'll turn to call back to Mark Foley.

Mark J. Foley: Thank you, Operator. In the coming months, we plan to attend the William Blair and Goldman Sachs Health Care conferences virtually. We welcome your requests for meetings at these events 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. This concludes today's conference call. You may now disconnect. Goodbye.

The free to reach out the 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.

This concludes today's conference call you may now disconnect.

Goodbye.

Okay.

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Operator: and so on the way. Thank you.

Yes.

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