Q4 2020 Revance Therapeutics Inc Earnings Call

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Operator: Welcome to the Revance Therapeutics fourth quarter and full year 2020 financial results and corporate update conference call. At this time, all participants are in a listen-only mode. Following management's prepared remarks, we will hold a Q&A session. To ask a question at that time, please press a star followed by one on your touchtone phone. If anyone has difficulty hearing the conference, please press star zero for operator assistance.

Welcome to the rhythms therapeutics fourth quarter, and full year, 'twenty and 'twenty financial results and corporate update conference call. At this time all participants are in a listen only mode. Following management's prepared remarks, we will hold a Q&A session.

To ask a question at that time. Please press star followed by one on your Touchtone phone. If anyone has difficulty hearing the conference. Please press star zero for operator assistance as a reminder, this call is being recorded today February 22, 2021, I would now like to turn the conference call over to Jessica Sara.

Operator: As a reminder, this call is being recorded today, February 22, 2021. I would now like to turn the conference call over to Jessica Serra, Head of Investor Relations and ESG for Revance. Please go ahead. Thank you, FATE.

Head of Investor Relations and ESG for Robinson. Please go ahead.

Thank you for fate.

Jessica Serra: Joining us on the call today from Revance is President and Chief Executive Officer Mark Foley, Chief Financial Officer Toby Schilke, Chief Operating Officer and President of R&D and Product Operations Dr. Abhay Joshi, Chief Commercial Officer Aesthetics and Therapeutics Dustin Sjuts, President of Innovation and Technology Aubrey Rankin, and Senior Vice President Clinical Development Dr. Roman, During this call, management will make forward-looking statements, including statements related to Revance's 2021 guidance, the clinical development of our product candidates, business strategy and planned operations, commercial launch of the RHA collection of dermal fillers and Henton D. Fintech platform, the timing of any potential approval of Daxibotulinum toxin A for injection by the FDA, the market opportunity of our aesthetics and therapeutics franchises, These forward-looking statements are based on the company's current expectations and inherently involve significant risks and uncertainties. Our actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, factors that could cause, Results to be different from these statements include factors the company describes in the section titled Risk Factors in our quarterly report on Form 10-Q as filed with the SEC on November 7, 2020.

Joining us on the call today from <unk>.

President and Chief Executive Officer, Mark Foley, Chief Financial Officer, Toby Schilke, Inc.

<unk> operating officer, and president of R&D and product operations Dr.

And by Joshi, Chief commercial officer aesthetics, and Therapeutics Dustin.

President of innovation and technology operating Reagan.

And senior Vice President clinical development Dr.

During this call management will make forward looking statements, including statements related to rebound since 2010.

And one guidance.

Clinical development of our product candidates business strategy and planned operations commercial launch of the RJ collection of dermal fillers and tend to decent tech platform. The timing of any potential approval of taxi botulinum toxin a for injection by the FDA the market opportunity of our study.

European ex franchises milestone expectations unexpected cash runway and financial performance.

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

Our actual results and the timing of events could differ materially from those anticipated.

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

That could cost.

The results to be different from these statements include factors. The company describes in the section titled Risk factors and our quarterly report on form 10-Q as filed with the SEC on November 7th.

'twenty and 'twenty.

Jessica Serra: Revance undertakes no obligation or obligation to update any forward-looking statements as a result of new information, future events, or changes in its expectations. Also, on today's call, we will present both GAAP and non-GAAP financial measures. A reconciliation of non-GAAP to GAAP measures is included in our earnings release. With that, I will turn the call over to Mark Foley.

Revamped undertakes no obligation or obligation to update any forward looking statements as a result of new information future events or changes and expectations.

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

<unk> measures is included in our earnings release.

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

Mark J. Foley: Thank you, Jessica. Good afternoon, everyone, and thank you for joining our fourth quarter and full year 2020 earnings conference call. 2020 was truly a transformational year for Revance. Our team more than doubled in size. We advanced both of our aesthetics and therapeutics pipelines and strengthened our balance sheet, extending our cash runway into 2024. We also integrated HintMD, a next-generation point-of-sale payment and consumer loyalty platform for aesthetic practices that provides us with a diversified revenue stream.

Thank you Jessica good afternoon, everyone and thank you for joining our fourth quarter and full year, 'twenty and 'twenty earnings Conference call.

'twenty and 'twenty was truly a transformational year for revamps.

Two more.

More than doubled in size, we advanced both of our aesthetics and therapeutics pipelines and strengthened our balance sheet, extending our cash runway into 'twenty and 'twenty four.

We also integrated and M D and next generation point of sale payments and consumer loyalty platform for static practices that provides us with a diversified.

Revenue stream.

Mark J. Foley: This year culminated with our successful transition into a commercial entity as we launched the RHA collection of dermal fillers and the HnMD FinTech platform. These would all be significant accomplishments in a normal year, but even more noteworthy against the backdrop of the global COVID-19 pandemic. I'm incredibly proud of our team for coming together during these challenging times and delivering on our key objectives for the year.

This year and culminated with our successful transition into a commercial entity as we launched the <unk> collection of dermal fillers and the N M D Fintech platform.

These would all be significant accomplishments and a normal year for even more noteworthy against the backdrop of the global COVID-19 pandemic.

I'm incredibly proud of our team for coming together during these challenging times and delivering on our key objectives for the year.

Mark J. Foley: Before I cover our fourth quarter highlights and milestones for this year, I'd like to review the results from our Juniper Phase 2 trial of Daxibotulinum toxin A for injection for adult upper limb spasticity, which we will refer to as adult ULS on this call. This is our second muscle movement disorder clinical program for Daxibotulinum toxin A for injection, and we are very pleased with the data from the phase two study Before I pass the call over to Roman to review the study, let me talk a little bit more about upper limb spasticity. Adult ULS is a condition that affects movement in the arms and hands, making muscles stiff, flexed, and sometimes spasm. It is most often caused by stroke, disease, or traumatic brain injury.

Before I cover our fourth quarter highlights and milestones for this year I'd like to review the results from our Juniper Phase II trial, Dachsie botulinum toxin day for injection for adult upper limb spasticity.

Which we will refer to as adult <unk> on this call.

This is our second muscle movement disorder clinical program for Doxey botulinum toxin day for injection and we are very pleased with the data from the phase II study.

Before I pass the call over to Roland to review the study, let me talk a little bit more about upper limb spasticity.

Adult <unk> is a condition that affects movement, and the arms and hands, making muscle stiff flex and sometimes spasm.

It is most often caused by stroke disease or traumatic brain injury.

Mark J. Foley: Although not life-threatening, spasticity can be painful and debilitating, impacting a patient's ability to perform daily tasks. Botulinum toxin injections have shown to be effective in relieving many symptoms of spasticity, particularly when combined with physical therapy. Injections are typically administered by physiatrists and neurologists who treat problems with the brain and nervous system. Total spasticity, which includes upper and lower limb spasticity, is one of the largest of the muscle movement disorders, representing a $620 million global opportunity in 2020 and expected to grow to over $1 billion by 2025.

Although not life threatening it can be painful and debilitating impacting a patient's ability to perform daily tasks.

<unk> line and toxin injections have shown to be effective and relieving many symptoms of spasticity, particularly when combined with physical therapy and.

Injections are typically administered by Physiatrists, and neurologists, who treat problems with the brain and nervous system.

Total spasticity, which includes upper and lower limb spasticity is.

The largest of the muscle movement disorders, representing $620 million global opportunity in 2020 and expected to grow to over $1 billion by 2025.

Mark J. Foley: The prevalence of spasticity is estimated to be 12 million people worldwide. However, less than 20 percent of patients receive treatment. As with cervical dystonia, there are challenges with the currently approved Fosulinum toxins in the treatment of adult ULS. In present-day practice, patients are typically injected every 12 weeks. However, patients often experience a return of symptoms prior to the approved treatment interval by payers. For these reasons, there is a significant unmet need in this patient population, similar to what is seen in cervical dystonia patients, for a long-lasting and more cost-effective therapy.

The prevalence of spasticity is estimated to be 12 million people worldwide, however, less than 20% of patients receive treatment.

As for cervical dystonia, there are challenges with the currently approved <unk> line and toxins and the treatment of adult <unk>.

And present day practice patients are typically injected every 12 weeks, however, patients often experience a return of symptoms prior to the approved treatment interval by payers.

For these reasons.

And there's a significant unmet need and this patient population.

To what is seen and cervical dystonia patients for a long lasting and more cost effective therapy.

Mark J. Foley: We hope that daxubotulinum toxin A for injection, once approved, would encourage a greater population of patients with this condition to seek treatment. Now, I'll pass the call to Roman to review the trial design and results.

And we hope that the oxy botulinum toxin and <unk> for injection once approved would encourage a greater population of patients with this condition to seek treatment.

Now.

I'll pass the call to Robyn to review the trial design and results Robyn.

Roman: Thank you, Mark. Howard Juniper's study was a Phase II randomized... A Double Blind Placebo Controlled Multicenter Trial to Evaluate the Efficacy and Safety of Daxibotulinum Toxin A for Injection for the Treatment of Adult ULS Following a Stroke or Traumatic Brain Injury. The study was also designed to identify a dose to help us advance into a phase three program. There were three doses of the drug evaluated, 250, 375, and 500 units compared with placebo.

Thank you Mark our Juniper study was a phase III randomized.

Double blind placebo controlled multi center trial to evaluate the efficacy and safety of taxi botulinum toxin.

<unk> injection for the treatment of adult <unk>, following a stroke or traumatic brain injury.

The study was also.

Designed to identify a dose to help us advance into a phase III program. There were three doses of the drug evaluated $2 15, $3 75, and 500 units compared with placebo.

Roman: The trial was originally designed to include 128 subjects, but given COVID-19 concerns, we made the decision in June of 2020 to curtail the enrollment size to 83 subjects. Our concerns were related to challenges with subject enrollment.

And <unk> was originally.

Designed to include 128 subjects, but given COVID-19 concerns we made the decision in June of 2020 to curtail the enrollment size to 83 subjects.

Our concerns were related to challenges with subject enrollment.

Roman: The scheduling of in-person study visits and the lack of a validated Assessment for Patients that could be used remotely, with a revised sample size of 83 subjects. We determined that the Phase II study design would still be adequate to meet the goal of identifying an acceptable dose with efficacy and safety, from an efficacy and safety standpoint, to advance into a Phase II program, especially given the known performance profile of other neuromodulators in the treatment of this condition. This study enrolled adult patients between the ages of 18 to 75 with moderate to severe upper limb spasticity at the elbow, wrist, and finger flexors.

The scheduling of in person study visits.

They're trying to lack of a validated.

Assessment for patients that can be used remotely.

With the revised sample size of 83 subjects.

We determined that the phase III study design would still be adequate to meet the goal of identifying and acceptable dose with an efficacy and safety from.

From an efficacy and safety standard.

And then to advance into a phase II program, especially given the known performance profile of other neuromodulators and the treatment of this condition.

The study enrolled adult patients between the ages of 18% to 75%.

With moderate to severe upper limb spasticity at the elbow wrist and finger <unk>.

Roman: We conducted the trial at 30 sites in the U.S., and patients were randomized one-to-one to one-to-one between active and placebo treatment groups. Unknown Speaker, designed to run up to 36 weeks with two co-primary outcome measures. First, the mean change from baseline and Muscle Tone at Week 6 that was measured with the Modified ASHRA Score, or MAS, and the most affected muscle group between the elbow, wrist, or finger flexors, which was designated as the suprahypertonic Muscle Group, or SMG.

<unk>.

Conducted the trial at 30 sites and the U S and patients were randomized one to one to one to one between active and placebo treatment groups and the study with.

Designed to run up to 36 weeks with two co primary outcome measures for.

And the mean change from baseline.

And.

Muscle tone at week, six that was measured with the modified ashworth score or MFS and the most effective and muscle group between the elbow wrist or finger flexors.

Which was designated as the Super Hypertonic.

Muscle group or SMG and second the main score of the.

Roman: And second, the mean score of the Physician Global Impression of Change, or PGIC, at Week 6. In addition, the duration of effect was evaluated as a key secondary. We'll now turn to the CUNAPR results on the co-primary endpoints at Week 6. The proof of concept was demonstrated with all three doses being numerically higher than placebo as measured on the MAS. The 500 unit dose was able to demonstrate a meaningful and statistically significant reduction of muscle tone on the MAS from baseline compared with placebo. Additionally, each of the three doses was able to demonstrate a numerical improvement when compared with placebo on the PGIC assessment. However, this difference was not able to reach statistical significance with the reduced enrollment size.

Position global impression of change or P. J at week six in addition, the duration of effect was evaluated as a key secondary endpoint.

I will now turn to the Juniper results.

On the co primary endpoints at week six.

The proof of concept was.

Constrained with all three doses.

Being.

Numerically higher than placebo as measured on the Emas for 500 unit dose was able to demonstrate a meaningful and statistically significant reduction of muscle tone on the MAA asked from baseline compared with placebo.

Additionally.

<unk> each of the three doses was able to demonstrate a numerical improvement when compared with placebo on the P. J assessment. However, this difference was not able to reach statistical significance with a reduced enrollment size.

Roman: That said, we were pleased and encouraged to see the treatment effect align with prior, https://www.kenhub.com, Type A toxin in adult upper-limb spasticity. A key secondary endpoint for Daxibotulinum toxin A for injection was the duration of effect. Unpublished, https://www.cdc.gov.au in that range with a duration that's been reported of 12 to 14 weeks. In our Juniper Phase 2 study, all three doses of Daxi for injection achieved a median duration of at least 24 weeks.

That said, we were pleased and encouraged to see the treatment effect with our data aligned with prior.

Studies that were with.

Type a toxin and adult upper limb spasticity.

A key secondary endpoint for Dachsie botulinum toxin day for injection was the duration of effect.

And published.

Literature.

That has been reported with other toxins.

Here to relief, usually peaks at four to six weeks with efficacy that will wane and.

And the.

And that range with a duration that's been reported of 12 to 14 weeks and our Juniper Phase II study all three doses of taxi for injection achieved and medium duration of at least 20.

And some weeks.

Roman: That was defined as a time from injection in weeks until a loss of muscle tone improvement as measured by the MAS for the suprahypertonic muscle group and the PGIC with a score of less than or equal to zero or a request for retreatment by the subject. Finally, in terms of safety, Doxybotulinum toxin A for injection was found to be generally safe and well-tolerated across all three doses, with no increase in the incidence of adverse events observed in the higher dose treatment group.

That was.

Defined as the time from injection and weeks until a loss of muscle tone improvement as measured by the emas for the Super Hypertonic muscle group and the P. J with a score of less than or equal to zero for a request for re treatment by the subject finally in terms.

For Lefty.

The oxy botulinum toxin and <unk> for injection was found to be generally safe and well tolerated across all three doses with no increase and the incidence of adverse events observed and the higher dose treatment groups and.

Roman: In summary, the study successfully was able to deliver the data that was required to properly design a phase three program. We were able to meet the co-primary efficacy endpoint as measured on the MAS. Even though a lower subject enrollment size was had secondary to COVID-19.

In summary, the study successfully was able to deliver.

And the data that was required to <unk>.

Terms of design a phase III program, we were able to meet the co primary efficacy endpoint is measured on the M. A S. Even though a lower subject enrollment size.

What had secondary to COVID-19, we also showed for consistent long duration profile for doxey of 24 weeks is seen across.

Roman: We also showed the consistent long-duration profile for DAXI of 24 weeks as seen across our other therapeutic and aesthetic studies. For these reasons, we are confident in the drug's ability to significantly improve patients' quality of life by achieving symptom relief with as few as two treatments per year. We plan to share the Juniper Phase 2 data set at an upcoming medical congress. In closing, we could not have achieved these results without the time and commitment of the patients, investigators, CROs, and members of the Revance team to the Juniper Program. We thank you all. I'll turn the floor back over to Mark.

Our other therapeutic and aesthetic studies.

For this for these reasons, we are confident and the drug's ability to be able to significantly improve patients quality of life by achieving symptom relief with as few as two treatments per year potentially.

We plan to share the juniper phase II dataset.

And at an upcoming medical Congress.

In closing we could not have achieved these results without the time and commitment of the patients and investigators crows and members of the advance team to the Juniper program. We thank you all I'll turn the floor back over to Mark.

Mark J. Foley: Thanks, Roman. To echo Roman's remarks, the Juniper Phase 2 trial was modified and completed under extraordinary circumstances and delivered the results that we needed in order to advance our program. We plan to schedule an end of Phase 2 meeting with the FDA prior to finalizing our Phase 3 program. As for the rest of our therapeutics franchise, the next milestone is the completion of the Aspen OLS Phase 3 Open Label Safety Study in Cervical Dystonia, expected in the second half of 2021.

Thanks Roman.

To Echo Robin's remarks.

The Juniper phase II trial was modified and completed under extraordinary circumstances and delivered the results that we needed in order to advance our program with.

And we plan to schedule and end of phase II meeting with the FDA prior to finalizing our phase III program.

As to the rest of our therapeutics franchise. The next milestone is the completion of the Aspen.

From our class Phase III open label safety study and cervical dystonia expected and the second half of 2021.

Mark J. Foley: We plan to follow this with a regulatory filing with the FDA in 2022 and anticipate approval in 2023. We're very pleased with the positive momentum in our therapeutics franchise, given the growing body of clinical evidence that further validates the differentiated performance profile of daxibotulinum toxin A for injection. This differentiation will allow us to effectively participate in the global muscle movement disorder market, which includes cervical dystonia and spasticity, representing a $1 billion opportunity today.

We plan to follow this with a regulatory filing with the FDA and 2022 and anticipate approval and 2023.

We're very pleased with the positive momentum and our therapeutics franchise given the growing.

Body of clinical evidence that further validates the differentiated performance profile of vaccine botulinum toxin day for injection.

This differentiation will allow us to effectively participate and the global muscle movement disorder market, which includes cervical dystonia and spasticity, representing a $1 billion opportunity.

And today.

Mark J. Foley: We continue to believe that the demonstrated long-duration, favorable safety profile, and high response rates of our next-generation neuromodulator could become the new standard of care for neurological muscle movement disorders. Longer duration of treatment effect also delivers meaningful pharmacoeconomic benefits including decreased annualized drug costs, decreased healthcare utilization, and a reduction in overall treatment costs. All together, doxybotulinum toxin A for injection has the ability to potentially expand the utilization of neuromodulators for patients with these debilitating conditions.

We continue to believe that the demonstrated long duration favorable safety profile and high response rates of our next generation neuromodulator could become the new standard of care for neurological muscle movement disorders.

Longer duration of treatment effect also delivers meaningful pharmacodynamic benefits, including.

As for annualized drug costs decreased healthcare utilization and a reduction and overall treatment cost altogether.

Vaccine botulinum toxin a for injection has the ability to potentially expand the utilization of neuromodulators for patients with these debilitating conditions.

Now I will turn.

Mark J. Foley: Now I'll turn to our performance for the fourth quarter. In our first full commercial quarter, we saw a strong uptake of our RHA collection and substantial growth in processing volume from our HINT MD platform. Our initial results were encouraging for two reasons. First, they show that our innovative and differentiated aesthetics portfolio is responding to consumers and health care providers. And second, it shows that our thoughtful and disciplined commercial strategy was successful in producing results.

<unk> performance for the fourth quarter.

And our first full commercial quarter, we saw strong uptake of our <unk> collection and substantial growth and processing volume from our <unk> platform.

Our initial results were encouraging for two reasons first it showed that our innovative and differentiated aesthetics portfolio is resonating.

And with consumers and health care providers and second it reflects that our thoughtful and disciplined commercial strategy was successful and producing results during.

Mark J. Foley: During the fourth quarter, we also announced positive results from our Phase II open-label upper facial line study, which further reinforced the favorable duration profile of daxibotulinum toxin A for injection. The study showed efficacy of none or mild wrinkle severity in at least 92% of subjects at week 4 for the combined treatment of glabellar lines, forehead lines, and crow's feet lines. Furthermore, the medium time to return to baseline wrinkle severity was at least 33 weeks or 7.6 months.

During the fourth quarter, we also announced positive results from our phase II open label Upper facial lines study, which further reinforce the favorable duration profile of.

Turn to our botulinum toxin day for injection.

The study showed efficacy of none or mild wrinkle severity and at least 92% of subjects at week four for the combined treatment of glabella lines for headlines and crow's feet lines further the medium time to return to baseline wrinkle severity with at least 30.

33 weeks for $7 six months.

Mark J. Foley: We had hoped that in the fourth quarter, we would secure FDA approval of our innovative, long-lasting neuromodulator, Daxibotulinum toxin A, for injection in the treatment of globular lines. However, as we announced in November, the BLA for Glabellar Lines remains in review due to the FDA's inability to conduct a mandatory inspection of our manufacturing facility as a result of COVID-19 travel restrictions. You will recall that we announced that the FDA did not indicate any further outstanding review issues beyond the pending on-site inspection.

We would hope that and the fourth quarter, we would secure FDA approval of our innovative long lasting neuromodulator taxi botulinum toxin a for injection and the treatment of glabella lines. However, as we announced in November the BLA for Glabella lines remains and review due to the FDA.

<unk> and ability to conduct a mandatory inspection of our manufacturing facility as a result of COVID-19 travel restrictions.

You will recall, we announced that the FDA did not indicate any further outstanding review issues beyond depending on site inspection.

Mark J. Foley: That said, we remain confident in the quality of our VLA submission and are hopeful for an approval in 2021. In the meantime, we continue to build traction in our aesthetics platform with the RHA collection and HintMD platform, which will provide a strong foundation for the commercial launch of Daxibotulinum toxin A for injection once approved. Now, I will turn the call over to Dustin to talk about the performance of our aesthetics business in the fourth quarter.

That said, we remain confident and the quality of our BLA submission.

And are hopeful for and approval in 2021.

In the meantime, we continue to build traction and our aesthetics platform with RJ collection and hit MD platform, which will provide a strong foundation for the commercial launch of <unk> botulinum toxin day for injection once approved.

Now, let me turn the call over to Dustin.

Talk about the performance of our aesthetics business and the fourth quarter.

Dustin S. Sjuts: Thank you, Mark. We are extremely pleased to see the early results of our Aesthetics commercial launch with the RHA Collection and the HempMD FinTech platform. The resilience of the aesthetics market and a V-shaped recovery are encouraging as we look to gain market share. Practices have adapted to the new normal and are adjusting their operations within the COVID environment to provide services to their patients.

Thank you Mark we're extremely pleased to see the early results of our aesthetics commercial launch with the IHA collection and the <unk> Fintech platform. The resilience of the aesthetics market and a V shaped recovery are encouraging as we look to gain market share and.

Practices have adopted.

And to the new normal and are adjusting their operations within the COVID-19 environment to provide services to their patients we're seeing more practices leveraging technology to conduct virtual patient consultations while over all demand for procedures continues to be healthy.

Dustin S. Sjuts: We're seeing more practices leveraging technology to conduct virtual patient consultations, while overall demand for aesthetic procedures continues to be healthy. Total RHA sales for the fourth quarter exceeded our internal expectations, totaling $10 million. For the full year, product sales were $12.9 million.

Total <unk> sales for the fourth quarter exceeded our internal expectations totaling 10 million.

And.

For the full year product sales were $12 $9 million, while we are still early and our commercial launch we are seeing solid productivity from the accounts that are adopting our AJ with strong reorder rates and a growing share of wallet within these accounts, we continue to be disciplined in our accounts selection focusing primarily on procedure accounts that value patient outcomes.

Dustin S. Sjuts: While we are still early in our commercial launch, we are seeing solid productivity from the accounts that are adopting RHA, with strong reorder rates and a growing share of wallet within these accounts. We continue to be disciplined in our account selection, focusing primarily on prestige accounts that value patient outcomes and experience over discounts. Through Revance U, we're making great progress in educating and training our target customers. Despite the evolving COVID landscape, our team has been able to leverage different forms of face-to-face training in all markets, as well as a robust virtual training program, utilizing highly experienced trainers from across the globe to provide an interactive training experience.

And experienced over discounts.

<unk>, we're making great progress and educating and training our target customers. Despite the evolving COVID-19 landscape. Our team has been able to leverage different forms of face to face training and all markets as well as a robust virtual training program utilizing highly experienced trainers from across the globe.

And it comes and interactive training experience during.

Dustin S. Sjuts: During the third quarter, we also launched the RHA Collection Flawless in Motion Campaign. The campaign educates consumers about our innovative hyaluronic acid, or HA, dermal fillers that address two primary consumer values, the desire for a natural look and clean beauty. It highlights the RHA Collection as the only FDA-approved HA filler designed for the correction of dynamic wrinkles and folds. The filler is also prepared by a gentle manufacturing process that preserves the natural structure of the HA, helping it resemble the natural HA found in the skin.

During the third quarter, we also launched the <unk> during the quarter. We also launched the IHA collection flawless and motion campaign the campaign educate consumers about our innovative hyaluronic acid or <unk>.

Dermal fillers and address two primary consumer values the desire for a natural look and clean.

Beauty highlights the IHA collection as the only FDA approved <unk> filler designed for the correction of dynamic wrinkles and folds. The fillers also prepared by a gentle manufacturing process that preserves the natural structure of the Hai, helping it resemble the natural Hai found and the skin.

Dustin S. Sjuts: We also executed social influencer campaigns and targeted digital media campaigns across channels with the goal of driving consumers to the practices that carry the RHA collection. Turning to HintMD, we gained traction and expanded processing volumes to an annualized run rate of over $200 million in Q4. We believe these results demonstrate both the resilience of the aesthetics market as well as the synergies created with the RHA collection. With our current focus on adding value to practices through payment processing and touchless smart payments, we are progressing our plans to release the next generation of HINTS MD in mid-2021 with vertical payback integration and additional features.

And so executed social influencer campaigns and targeted digital media.

Campaigns across channels with the goal of driving consumers to the practices that carry the RJ collection.

Turning to hint M. D. We gained traction and expanded processing volumes to an annualized run rate of over $200 million and Q4.

We believe these results demonstrate both the resilience of the aesthetics market as well as the synergies created with the IHA collection.

<unk> for the current focused add value to practices through payment processing and touchless smart payments, we are progressing our plans to release and next generation <unk> and mid 2021 with vertical payback integration and additional features.

Dustin S. Sjuts: All together, our field force doubled our aesthetic counts across RHA and hence MD from the third quarter. We ended the year with over 1,000 counts combined, which we expect to grow over time under our Prestige Strategy.

Altogether, our field force doubled our set of accounts across our <unk> and <unk> from the third quarter.

We ended the year with over 1000 accounts combined which we expect to grow over time under a prestige strategy and.

Dustin S. Sjuts: In preparation for the anticipated FDA approval for our next generation neuromodulator, Daxibotulinum Toxin A for injection, Ingo Beller Lines, we continue to build out and test the infrastructure, operations, and back-office support to ensure a smooth launch upon approval. The successful launch of the RHA collection has paved the way for strategic investment of resources to ensure that the onboarding and integration of our next generation neuromodulator into the practice will be smooth The aesthetic foundation that we are laying today, along with the positive phase two upper facial line study, will undoubtedly serve as a strong launch pad for Daxibotulinum toxin A for injection upon approval.

And for the anticipated FDA approval for our next generation Neuromodulator, <unk> botulinum toxin a for injection and Gabon lines, we continue to build out and test the infrastructure operations and back office support to ensure.

Smoothed launch upon approval successful launch of the <unk> collection has paved the way for strategic investment of resources to ensure that the onboarding and integration of our next generation neuromodulator into the practice will be smoothed.

And the aesthetics foundation that we're laying today along with the positive phase II upper facial lines study will undoubtedly serve as a strong.

Ensure bad for Doxey, botulinum toxin and <unk> for injection and upon approval.

Dustin S. Sjuts: Further, a Pre-Market Approval Application, or PMA, for RHA-1 for Perioral Lip Lines has been submitted to the FDA by our partner, Tiaxing SA. They're anticipating approval in the second half of the year. Once approved, RHA will be a great addition to our collection. While we are still early in our launch in continued uncertain market conditions, we are encouraged by our market inroads and incredibly proud of what all of our commercial team has accomplished. We remain focused on our long-term growth prospects in a thriving aesthetics industry. Now, I'll turn the call over to Toby to cover the fourth quarter and full year financials.

Further pre market approval application or PMA for IHA, one for Perry oral lip lines has been submitted by the up to the FDA by our partner <unk> SA.

And they are anticipating and approval and the second half of the year once approved <unk> will be a great addition to our.

Our collection, while we're still early and our launch and continued uncertain market conditions. We are encouraged with our market inroads and incredibly proud of what all of our commercial team has accomplished we remain focused on our long term growth prospects and a thriving aesthetics industry now I'll turn the call over to Toby to cover the fourth quarter and full year financials.

Tobin C. Schilke: Thanks, Dustin. The earnings release we issued today outlines our financial results in full, so I'll touch on the highlights on this call. Total revenue is $15.3 million for the full year 2020. The breakdown for full year revenues was $12.9 million from the RHA collection.

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

Total revenue was $15 $3 million for the full year of 2020, the breakdown for full year revenues was $12 $9 million from the RH a collection.

Tobin C. Schilke: $2.0 million from our Viatris partnership and $0.4 million from the HintMD platform, an acquisition you will recall we closed on July 23, 2020. Gap operating expenses were $288.5 million for the year, excluding RHA-related in-process R&D, stock-based compensation, depreciation and amortization, and costs of revenue. Non-gap operating expenses were $225.8 million for the year. Both were in line with our previously announced guidance. Cash equivalents and short-term investments as of December 31, 2020 were $436.5 million, which we believe is sufficient to extend our cash runway into 2024, underlying our current operating plan.

<unk> $2.0 million from our <unk> partnership and zero point $4 million from the MD platform and acquisition you will recall, we closed on July 23 2020.

GAAP operating expenses were $288 $5 million for the year.

Excluding <unk> related in process R&D stock based compensation depreciation and amortization and cost of revenue non-GAAP operating expenses were $225 8 million for the year both were in line with our previously.

<unk> announced guidance.

Cash cash equivalents and short term investments as of December 31, 2020 for $436 5 million, which we believe is sufficient to extend our cash runway into 2024.

Underlying our current operating.

Lee.

Tobin C. Schilke: We are very pleased to be in the strongest cash position in our company's history, supported by our first product revenues and successful financings, including proceeds from our ATM facility. In terms of outlook, 2021 GAAP operating expenses are expected to be in the range of $375 to $390 million, compared to our non-GAAP operating expenses range of $270 to $285 million. As a reminder, non-GAAP operating expenses exclude cost of revenue, depreciation, and amortization, and stock-based compensation.

We are very pleased to be and the strongest cash position and our company's history supported by our first product revenues and successful financings, including proceeds from our ATM facility.

In terms of outlook 2021, GAAP operating expenses are expected to be.

And the range of $375 million to $390 million compared to our non-GAAP operating expenses range of $270 million to $285 million.

And as a reminder, non-GAAP operating expenses exclude cost.

Planned revenue depreciation and amortization and stock based compensation.

Tobin C. Schilke: We expect 2021 non-GAAP research and development expenses, including HINT-MD, to be $95 to $105 million. In terms of future revenue, we do not feel it is prudent to provide guidance given the early stage of our RHA collection and HINT-MD platform launches and the continued uncertainty fueled by the COVID-19 pandemic. Finally, Revance's shares outstanding as of February 12, 2021 were approximately 71.4 million, with 76.5 million fully diluted shares, excluding the impact of convertible debt.

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

In terms of future revenue, we do not feel it is.

As prudent to provide guidance given the early stage of our <unk> collection and MD platform launches and the continued uncertainty fueled by the COVID-19 pandemic.

Finally, <unk> shares outstanding as of February 12, 2021 were approximately $71 4 million.

And with 76 5 million fully diluted shares excluding the impact of convertible debt with that I'll turn the call over to Mark.

Mark J. Foley: With that, I'll turn the call over to Mark. Thank you, Toby.

Thank you Tobey.

Mark J. Foley: We believe that our strong financial position and innovations behind our aesthetics and therapeutics franchises will enable us to be a formidable competitor in the established markets that we enter. To that end, we look forward to building on the progress we've made in 2020 by continuing to invest in innovation and unlocking additional value for our shareholders in 2021. Before I conclude, I want to note that we published our first ESG report earlier this year, which detailed our commitments and efforts to build strong corporate governance and operate sustainably and responsibly.

And we believe that our strong financial position and innovations behind our aesthetics and therapeutics franchises will enable us to be a formidable competitor.

Established markets that we enter to that and we look forward to building on the progress. We've made in 2020 by continuing to invest in innovation and unlocking additional value for our shareholders and 2021.

Before I conclude I want to note that we published our first ESG report earlier, this year, which detail.

<unk> and commitments and efforts to build strong corporate governance, and operating sustainably and responsibly.

Mark J. Foley: This is an important pledge by the entire Revance team and our board of directors to further our efforts in building long-term value for all of our stakeholders, particularly as we enter the commercial stage of our evolution. We look forward to advancing our ESG program in the years ahead.

This is an important pledged by the entire <unk> team and our board of directors to further our efforts and building long term value for all of our stakeholders, particularly as we entered the commercial stage of our evolution.

We look forward.

And to advancing our ESG program in the years ahead.

Mark J. Foley: On that note, I'd like to highlight our latest governance update. Earlier today, we announced the addition of two new independent directors, Olivia Seaware and Kerry O'Connor-Kalaja, to our board. Olivia brings deep experience across commercial, clinical development, and portfolio management from leading firms including Principia, SideRx, Genentech, and Baxter. Kerry is a recognized thought leader and executive in the fintech and payment space, having served as the Global Chief Product Officer at Citi Fintech and Vice President of Global Consumer Products at PayPal.

On that note I'd like to highlight our latest governance update.

Earlier today, we announced the addition of two new independent directors, Olivia Seaware and carry O'connor, Colombia to our board.

Olivia brings deep experience across commercial and clinical development and.

And portfolio management from leading firms, including Principia side, Rx Genentech and Baxter.

Kerry is a recognized thought leader and executive and the Fintech and payment space, having served as the global Chief product officer at safe intact, and Vice President of global consumer products and Paypal.

Mark J. Foley: Their backgrounds and experiences will be invaluable to our board and organization as we advance our growth initiatives. In that press release, we also announced that two of our longstanding directors, Phyllis Gardner and Bob Burns, have decided to retire from the board and not stand for re-election at this year's annual shareholder meeting. The announcement is consistent with our new 12-year director tenure policy that aims to facilitate board refreshment while also enhancing diversity.

Problems and experiences will be invaluable to our board and organization as we advance our growth initiatives.

And that press release, we also announced that two of our long standing directors, Phyllis Gardner and Bob Burns have decided to retire from the board and not stand for reelection at this year's annual shareholder meeting.

The announcement is.

Consistent with our new 12 year director tenure policy that aims to facilitate board refreshment, while also enhancing diversity.

Mark J. Foley: Both Phyllis and Bob have served on the Revance board for over 15 years and have made invaluable contributions to the organization all along the way. In particular, they played pivotal roles in guiding Revance through its clinical development, financing, IPO, and, more recently, its commercial debut. So, on behalf of the entire organization, I want to express our sincere gratitude to Phyllis and Bob for their service and contributions to Revance. With that, I will now open the call up for questions, Operator.

Both Phyllis and Bob has served on the <unk> board for over 15 years and have made invaluable contributions to the organization all along the way in.

In particular, they played pivotal roles and guiding revamps through our clinical.

They are bad and financings IPO and more recently our commercial debut.

So on behalf of the entire organization I want to express our sincere gratitude to Phyllis involved for their service and contributions to revamp.

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

Operator: Thank you, sir. Ladies and gentlemen, if you have a question at this time, please press the star and then the number one key on your touchtone telephone. If your question has been answered or you wish to remove yourself from the queue, please press the pound key. Your first question is from Ken Casciatore from Coward & Company. Your line is open.

<unk>.

Development, ladies and gentlemen, if you have a question and at this time. Please press. The Star then the number one key on your Touchtone telephone and for your question, Anthony and answered for wished and remove yourself from the queue. Please press the pound key.

Your first question is from Ken Cacciatore from Cowen and company. Your line is open.

Mark J. Foley: Hey guys, congratulations on all the continued progress. So just a couple questions. The first, understanding you don't want to nuance too much on revenue guidance, but can you help us with the fillers concerning, is there any buy-in? I know there was nice commentary about the good reorder pattern, but as we think about the first half of the year, should we be thinking of a little bit of a step down before you reload and kind of regrow off of the Q4 level?

Hey, guys congratulations.

And as on all the continued progress. So just a couple of questions. The first understanding you don't want and nuance too much on revenue guidance, but can you help us with the pillars.

Concerning is there any buy and I know there was nice commentary about good reorder pattern, but as we think about.

First half of the year should we be thinking of a little bit of a step down before you reload and.

Police and kind of re grow off for the Q4 level just any any nuance. If you can help us there so we don't.

Mark J. Foley: Just any nuance if you can help us there so we don't get too far over our skis. And then wondering about the DAXE kind of regulatory communications. Obviously, we're waiting for the inspection, but I don't know, Mark, if you'd be willing to talk about any kind of labeling discussions or give us any nuance about the communications at that level as we wait for that to be finalized. And then lastly, just wanted to ask strategically: obviously, wonderful progress on the therapeutic side of the fence, and we're going to continue to invest in them.

Get too far over our skis and then wondering on the taxi.

Regulatory communications, obviously, we're waiting for the inspection, but I don't know mark if you'd be willing to talk about any kind of labeling discussions or give us any.

And once about the.

The communications at that level as we as we wait for that to be finalized and then lastly.

Just wanted to add strategically obviously wonderful progress on the therapeutic side of the fence and we get and continue to invest behind them.

Mark J. Foley: Can you talk about the balance between maybe looking to partner those assets versus you wanting to keep them whole? Obviously, you have a kind of wonderful, both the aesthetic side and the therapeutic side, but how do you balance these two? Are we going to keep investing, trying to keep them whole, or are you thinking about maybe starting to talk about or think about licensing? Thanks so much.

And talk about the balance between.

Maybe looking to partner those assets.

Versus you wanting to keep them whole honestly.

You've kind of wonderful both aesthetic side and the therapeutics side, but how do you balance. These two is it are we going to keep investing try to keep them all.

Or are you thinking about maybe starting to talk about or think about.

Any new and thanks, so much.

Mark J. Foley: Yeah, again, this is Mark. So, let me kind of walk you through the different questions. So first one on revenue cadence on the filler line. As you know, we're one quarter into our launch. And I think that's part of the reason we've said we're not in a position to give guidance yet, just because we're only one quarter in. And obviously, we've got seasonality; Q4 historically is a big quarter, partly because of, you know, consumer demand, and partly because of year-end programs that are designed by, you know, some of the large companies to incentivize purchases. And then you've got, obviously, COVID that's going on. And on top of that, you know, you had one week out of the quarter where some parts of the country were shut down due to, you know, cold temperatures.

Yes, and this is mark so let me kind of walk through the different questions. So first one on revenue cadence on the filler line as you are aware, we're one quarter into our launch and I think that's part of the reason we've said we're not in a position to give guidance yet.

Just because we're only one quarter in and obviously, we've got seasonality Q for historic.

<unk> is a big quarter, partly because of consumer demand and partly because of year and programs that are designed by.

Some of the large companies to incentivize purchases and then <unk> got obviously COVID-19, that's going on and on top of that you had the one week out of the quarter, where some of the country with.

And was shut down due to cold temperatures I paint all of that because.

Mark J. Foley: I'm painting all of that because we just think we're early in this process to really fully understand launch trajectory and the patterns, but we're obviously really encouraged with how it's going. And so you know, on the positive side, we're launching a brand new product in a very targeted fashion. I think it's just a little premature, and I understand that you're trying to figure out how to, you know, build your models and what to put there.

We just think we're early in this process to really fully understand launch trajectory and the patterns, but we're obviously really encouraged with how it's going and so on the positive side, where we're launching a brand new product and a very targeted.

Good fashion.

I think it's just a little premature and I understand that you're trying to figure out how to.

Build your models and what to put there, but I think we're still a little bit away from being able to give.

Mark J. Foley: But I think we're still a little bit away from being able to give numbers with a little bit more confidence there. So stay tuned. But you know, we are encouraged by what we're seeing in the marketplace. I will say one other thing that we found is that, you know, procedure volumes are encouraging. We're definitely seeing a V-shaped recovery and good volume, although access to accounts can be a little bit more challenging. You know, in more traditional times, you can see reps sort of swinging by accounts unannounced checking in.

Numbers with a little bit more confidence there so stay tuned on that.

But we are encouraged by what we're seeing and the marketplace.

I will say one other thing that we found is that Youll procedure volumes are encouraging we're definitely seeing a V shape recovery and good volume and access to accounts can be a little bit more challenging and more.

More traditional times, you can see reps sort of swinging by accounts unannounced checking in.

Mark J. Foley: That engagement has become a little bit more regulated as accounts are sort of focused internally. And, you know, they have some things that they're working through in terms of, you know, staff and, you know, access to schools and those sides of things. And so I think we're just early. Again, we're really encouraged by what we're seeing in the launch trajectory and the validation of the strategy. So as we have kind of more data points that we can rely on, we'll certainly share those.

That engagement has become.

Come a little bit more regulated as accounts are sort of focused internally and.

They have some things that theyre working through in terms of staff and.

Access to schools and those sides of things and so I think we're we're just early again, we're really encouraged by what we're seeing and the launch trajectory and the validation of the strategy. So as we have.

And kind of more data points that we can rely on and we'll certainly share those on the dachsie regulatory side as Youre aware and Q4, we got out in front of our <unk> date of November 25th and indicated that and inspection had not taken place and and the reason we did that is we broke with tradition of commenting on where we are and the regulatory process because.

Mark J. Foley: On the DACC regulatory side, as you are aware, in Q4, we got out in front of our PDUFA date of November 25th and indicated that an inspection had not taken place. And the reason we did that was we broke with tradition of commenting on where we are in the regulatory process because given the unique environment with COVID-19 and the inability for the FDA to do inspections, we knew that with this date coming up, we weren't going to hit it. We then moved into sort of the deferral category where there's no statutory timeframe.

Given the unique environment with COVID-19, and the inability for the FDA to do inspections, we knew that with his day coming up we weren't going to hit it.

We then moved into sort of the deferral category, where there is no statutory timeframe and we think frankly, it's prudent for us to go back to typical company policy and not comment on where.

Mark J. Foley: And we think, frankly, it's prudent for us to go back to typical company policy and not comment on where we are there. You know, you asked the question about where we had other aspects of the overall review. You know, in November, we did indicate that the FDA didn't indicate that there was anything outstanding other than the actual facility inspection.

We are there.

You asked the question about where we had other aspects of the overall review.

In November we did indicate that the FDA.

Didn't indicate that theres anything outstanding other than the actual facility inspection. So we are excited to get the product.

Mark J. Foley: So, you know, we are excited to get the product on the market as soon as possible, but we're going to revert back to prior company policy and not comment on the specifics there. And then, on the therapeutic side of it, like you, we're obviously very encouraged by what we continue to see out of our therapeutics pipeline. I think that, you know, with each additional clinical trial program that we run, we continue to see a very consistent duration of effect of our neuromodulator and, you know, a very encouraging kind of safety and efficacy profile.

On the market as soon as possible, but we're going to revert back to prior company policy and not comment on the specifics there.

And then lastly on the therapeutic side of it like we're obviously very encouraged by what we continue to see out of our therapeutics pipeline I think that with each additional clinical trial program that we run we continuously.

To see a very consistent duration of effect of our neuromodulator.

And very.

Encouraging.

It's kind of safety and efficacy profile.

Mark J. Foley: So I think that what we've messaged earlier is that we wanted to get through what was a pretty heavy phase of clinical data readouts. Certainly now that we've got the phase two adult upper limb spasticity data in hand, we're going to circle back and spend more time, you know, addressing the kind of question you raised. You know, do we partner this out? How do we think about this overall? We've obviously got capital allocation and other decisions that we need to work our way through.

So I think that what we've what we've messaged earlier is that we wanted to get through what was a pretty heavy phase of clinical data readouts.

And now that we've got the phase III adult upper limb spasticity data in hand, we're going to circle back up and spend more time.

Addressing kind of the question you raised do we partner this out how do we think about this overall, we've obviously got capital allocation and other decisions that we need to work our way through so more to come there, but certainly with.

Mark J. Foley: So more to come there, but certainly with the data that we've generated, we think it opens up sort of a lot of optionality for us as we look ahead and try and figure out the best way to drive shareholder value.

Sort of weighted that we've generated and we think it opens up sort of a lot of optionality for us as we look ahead and try and figure out the best way to drive shareholder value.

Mark J. Foley: Great. Thanks so much.

Great. Thanks, so much.

Operator: Thank you.

Operator: Your next question is from Seamus Fernandez from Guggenheim. Your line is open.

Your next question is from Seamus Fernandez from Guggenheim. Your line is open.

Seamus Christopher Fernandez: Oh great, thanks guys. So just a couple of questions. First, on the upper limb spasticity opportunity, can you just help us understand the dose that you're most likely to select going forward? And where you have the highest conviction, it sounds like it's more the size of the study, but certainly the 500 being statistically significant while the others were not. I mean, that could be variability, or it could just be the effect size. So I would love to get a little bit more color on how we should be thinking about the dose going forward. And the magnitude of effect, obviously, six months very positive, especially in this disease setting.

Alright.

With the Dick's guidance, so just a couple of questions.

First on the upper limb spasticity opportunity.

Can you just help us.

And I understand the dose that you're most likely to select going forward.

And we have the highest conviction and it sounds like it's.

Great.

Study.

But certainly the 500 being statistically significant and while the others will not and.

And that could be variability or it could just be the effect size. So just wanted to get a little bit more color on how we should be thinking about the dose going forward.

And the magnitude of effect, obviously six months.

More of a positive, especially in this disease setting.

Seamus Christopher Fernandez: And then the second question, Mark, you spoke about HINT-MD and the contribution that HINT-MD can actually make to the overall organization. Just hoping that you could help us understand a little bit how this program and this effort are going to advance through the balance of the year as, obviously, the other capabilities start to come online. Just hoping you could walk us through some of those incremental capabilities that will be coming online and what you feel they do for the overall aesthetic organization. Thanks.

And then the second question, Marc and just wanted to you've spoken about the hint MD and.

And the contribution that it can be can actually make.

The overall organization.

Just hoping that you could help.

US understand a little bit how.

This program and this effort is.

And to advance through the balance of the year.

And with.

As you know obviously the other capabilities start to come online and just hoping you could walk us through some of those incremental capabilities that would be coming online and.

But I feel they do for the year.

Overall aesthetic organization. Thanks.

Mark J. Foley: Thanks, Seamus. So, the first one as it relates to dose, clearly, you know, we ran this, you know, largely to inform our dosing strategies we would move forward into a Phase III program. The other nice thing is, you know, this is a market that's fairly well characterized. I mean, there are competitor products that are in the market, there's extensive literature to look at, and we obviously benefit from the historical clinical trial programs that we have.

Thanks, Seamus so the first for as it relates to dose.

Clearly we ran this largely to inform our dosing strategies, we would move forward into a phase III program.

The other nice thing is this is a market that's fairly well characterized.

I mean, there is a competitor products that are in the market. There is extensive literature to look at and we obviously benefit from the historical <unk>.

Mark J. Foley: So, as you noted, the 500-unit dose did show statistical significance. We think that, along with the other information that we have from the trial, will provide us, you know, sort of with the necessary background that we need to advance into a good Phase II, end of phase II meeting with the agency. And again, I think over time, too, we've got a much better appreciation for the kind of core active neurotoxin in our product versus others and how those relate.

Clinical trial programs that we have so as you noted the 500 unit dose did show statistical significance, we think that along with the other information that we have from the trial will provide us.

And what you know with the necessary background that we need to advance and do a good phase II and the phase II meeting with the agency and.

And I think over time too we've got a much better appreciation for kind of core active neurotoxin and our product versus others and how those relate as you mentioned, we did reduce the size of the study for all the reasons that Rob had mentioned.

Mark J. Foley: As you mentioned, we did reduce the size of the study for all the reasons that Roman mentioned. Certainly, patient recruitment was challenging, and follow-up was challenging, but we felt that by truncating the study, we would still have adequate information to inform the next step. So, I think there's more to come.

Sort of certainly patient recruitment was challenged follow up was challenging but we felt that by truncating. The study that we would still have adequate information to inform the next steps. So I think its more to come and we want to have that and a phase II meeting before solidifying a dose, but as we highlighted certainly the 500 unit dose.

Mark J. Foley: We want to have that end of Phase II meeting before solidifying a dose, but, you know, as we highlighted, certainly the 500-unit dose was the one that showed statistical significance in one of the co-primary endpoints. In terms of the HintMD contribution, let me just kind of maybe reframe it again. You know, when we got into this, we talked about this payment platform. It's having the ability to participate in the overall credit card margin that's generated on every transaction, and that margin is kind of 2.4% to the low 4% on any transaction where there is a credit card used.

The one that showed statistical.

And and efficacy.

And one of the co primary endpoints.

In terms of the head and the contribution let me just kind of maybe reframe. It again when we when we got into this we talked about this payment platform as having the ability to participate and the overall credit card margin that's generated on every transaction.

<unk> margin is kind of two 4% to the low 4% on any transaction, where theres a credit card use.

Mark J. Foley: What would impact that sort of widespread is, is it Amex, is it Visa? Do they have the credit card with them, or is it some sort of card not present where somebody gives their credit card number over the phone, and that carries with it a little higher fraud risk, which is why those rates swing.

Impacts that sort of widespread is it amex's at visa do they have the credit card with them or is it sort of.

Card not present, where somebody gives their credit card number over the phone and.

And that was with a little higher fraud risk and which is why those rates swing, we participate and 50 to 100 basis points of that overall transaction. So that's our market opportunity.

Mark J. Foley: We participate in 50 to 100 basis points of that overall transaction, so that's our market opportunity. Once we, you know, in part of our integration planning and our strategic exercise when we did the modeling, we sort of recognized that there was going to be sort of a rebasing of the business when we acquired it, because there were things that they were working on that were a little bit outside of our initial strategic focus, and so we've worked our way through that.

And once we and part of our integration planning and our strategic exercise when we did the modeling we sort of recognize that there was going to be sort.

And that re basing of the business when we acquired it because there were things that they were working on that were a little bit outside of our initial strategic focus and so we've worked our way through that over the last period of time. Our primary focus has just been on processing transactions and allowing for remote for contactless payments, particularly in this COVID-19 environment, So thats kind of our phase.

Mark J. Foley: Over the last period of time, our primary focus has just been on processing transactions and allowing for remote or contactless payments, particularly in this COVID environment, so that's kind of our phase one. The next step, and we talked about it in our prepared remarks, is becoming what's called a payment facilitator. We expect that to happen kind of in the middle of this year, so mid-2021, and once we become a payment facilitator, we'll have much better access to the source data, which will make it easier for us to turn on some of the other programs that we've historically talked about, subscriptions, white-label loyalty, better insight for data analytics for practices, and even some other partnering opportunities.

Sort of.

The next step and we talked about it and our prepared remarks is becoming what's called a payment facilitator, we expect that to happen kind of mid of this year. So mid 2021, and once we become a payment facilitator, we will have.

Much better access to the source of data, which will be easier for us to turn on some of the other programs that we have historically.

They talked about subscriptions white label loyalty.

And site for data analytics for practices and even some other partnering opportunities. So right now the primary value proposition for the platform is really is a competitive from a pricing standpoint, and do they see value and remote.

Mark J. Foley: So right now, the primary value proposition for the platform is really, is it competitive from a pricing standpoint, and do they see value in remote or contactless payments, and then, hey, do they want to start to lean in with us as a company? As we start to turn on these other services in the middle of the year, we think that we're going to be able to add incremental value. We think that subscriptions are going to show practices how they can generate more profitability and better patient retention, the same with loyalty programs and then any kind of partnership that we do.

One on taxes payments and then he did they want to start to lean in with US as a company as we start to turn on these other services middle of the year.

We think that we're going to be able to add incremental value. We think that subscriptions are going to show practices, how they can generate more profitability and better patient retention and same with loyalty programs and then any kind of pause.

Out of accounts that we do so when we start to roll these out and the summer we think that the overall hit and the platform is going to be much more compelling from a value add.

Mark J. Foley: So when we start to roll these out in the summer, we think that the overall HintMV platform is going to be much more compelling from a value add perspective. From an overall margin contribution standpoint, you know, we still have some work to do to figure out whether or not, as we turn on these services, we're going to increase the sort of the fee that we charge and, therefore, enhance our profitability, or will we turn around and reinvest that in the practice to reward, you know, product purchases and others.

And from an overall margin contribution.

Still have some work to do to figure out whether or not as we turned on the services, we're going to increase sort of the fee that we charge and therefore enhance our profitability.

<unk> or when we turn around and reinvest that and the practice to reward product purchases and others and so there is still we need a little more time before we're comfortable sort of signaling the way we're going to go but we're excited about sort of its next generation of the product platform. This summer.

Mark J. Foley: And so there's still, you know, we need a little more time before we're comfortable sort of signaling the way we're going to go, but we're excited about sort of this next generation of the product platform this summer.

Mark J. Foley: Great. Thanks, Mark. Thank you.

Great. Thanks, Mike.

Operator: Thank you.

Sure.

Yes.

Operator: Your next question is from Terence Flynn from Goldman Sachs. Your line is open.

Your next question is from Terence Flynn from Goldman Sachs. Your line is open.

Terence C. Flynn: Great. Thanks for taking the questions. Maybe two for me.

Great. Thanks for taking the questions.

Maybe two for me Duston I was just wondering if you can give us any perspective on kind of what youre seeing early in the year here January February and maybe relative to what.

Dustin S. Sjuts: Dustin, I was just wondering if you can give us any perspective on kind of what you're seeing early in the year here, January, February, maybe relative to what you saw in December. And you noted you're pleased with your share of the wallet at this point. Maybe you could elaborate a little bit more there. And then, Mark, on the DAXI inspection, recognizing you're not going to say a lot given the ongoing communications with regulators, but as we look at the year, would you recommend we anchor to kind of a fourth quarter launch or midyear, just trying to think about as you kind of level set everybody here on the pacing of that DAXI launch? What would you recommend? Thanks?

Thank you for December and you noted you're pleased with your share of wallet at this point, maybe you could elaborate a little bit more there and then.

On the taxi inspection and recognizing you're not going to say a lot given the ongoing communications with regulators, but.

As we look at the year would you recommend.

And we anchor to kind of a fourth quarter launch or mid year, just trying to think about.

And kind of level set everybody here on pacing of that taxi launch what would you recommend thanks.

Dustin S. Sjuts: Hey Terence, it's Dustin. I'll start a little bit on the January-February side. We really haven't seen much of a difference between, you know, today versus kind of Q4. I think in the market, you'll find there are a lot of programs that Mark talked about in terms of consumer-driven programs and coupons as well as almost like those frequent flyer programs that the big companies have that are trying to drive these end-of-the-year big purchases.

Hey, Thanks, Terence as Dustin and I will start a little bit on the January February side, we really haven't seen much of a difference between.

Today versus kind of Q4 I think in the market you will find there is a lot of programs that mark talked about in terms of consumer driven programs and coupons as well as almost like those those frequent flyer programs that the big companies have that are trying to drive. These individual large purchases that has at times have impact on and accounts ability.

Dustin S. Sjuts: That has, at times, had an impact on an account's ability to say, hey, am I wanting to take on a new account or am I wanting to take on a new product today? And so the good thing is we have different accounts at different times. We've got some that are utilizing our training materials and really getting up to speed with how that product works. We've got some that are fully integrating RHA into their practice, which we'll talk about in a second from a share of wallet.

To say I'm wanting to take on a new calendar and I wanted to take on a new product today and so the good thing is we have different accounts and different time periods. We've got some that are that are utilizing our training materials and really getting getting up to speed with how that product works. We've got some that are fully integrating <unk> into their practice, which we'll talk about and the second from share of wallet and we've got others that are starting with.

<unk> and the demonstration products. So we feel good about having an offering for folks that are different buying periods today and theres lots of those opportunities out there from a share of wallet perspective, we found as we first launching remember we're the first company that has launched with all products of one times, we've launched with <unk> three and for so three different.

Dustin S. Sjuts: And we've got others that are starting with samples and demonstration products. So we feel good about having an offering for folks that are in different buying periods today. And there are lots of those opportunities out there. So we've shown that once they get confident with the range, we're not just seeing one hero product come in. They're coming back, and they're using all three of those products. We feel really good. Once they get it into their practice, they continue to grow the product. So with that, I'll turn it over to Mark on the other question. Yes, it's Terence.

The SaaS skus that all have different profiles that provide.

And for that position that flexibility for how they want to utilize the product and so we've shown that once they get confident with the range that we're not just seeing one hero product come in they're coming back and are using all three of those products. We feel really good once they get it into their practice that continue.

Mark J. Foley: Thank you, Terence. In terms of, you know, timing for DAXI, again, I think that, you know, given that we're not able to make comments or have chosen not to because of previous company policy and history, we're not really able to share a whole lot of insight in terms of how to think about guiding you to it. So clearly, with the whole deferral category and no set timing, we just, there's not a whole lot more that we're able to offer on that side of it, but we, again, continue to feel great in terms of what we're doing with the RHA line of fillers and our ability to broaden our footprint in the market combined with our HINT platform. And we're just excited and looking forward to getting that product into the market Great. Next question.

And to grow the product so with that I'll turn it over to Mark on the other question, yes. The tariffs in terms of timing for <unk> again, I think that.

Given that we're not able to make comments or have chosen not to because of.

Prior company policy and history, and we're not really able to share a whole lot of insight in terms of how to think about.

Guiding you to it so.

Clearly with the whole deferral category and no set timing.

There's not a whole lot more that we're able to offer on that side of it but we and we continue to feel great in terms of what we're doing with our H E.

Your line of fillers, and our ability to broaden our footprint and the market combined with our <unk> platform and.

And we're.

And just excited and looking forward to getting that product into the market as soon as possible.

Great next question.

Mark J. Foley: Thank you. Your next call is Annabel Samimy from Stevo. Your line is open.

Thank you for your next question.

From Stifel. Your line is open.

Annabel Eva Samimy: Hi, thanks for taking my question. I was wondering if you could give us a little bit more granularity on the launch. I think you mentioned you had reached about 500 accounts in the third quarter, and so this quarter, have you grown that account base, or was the growth primarily on reorder rates? And given the good reception, is there any thought to further broadening the reach to new accounts or changing strategy, especially in light of DAX being delayed, AVI, I guess, doing further investment and innovation on the filler side, and you having a singular focus on RHA

Hi, Thanks for taking my question I was wondering if you can give us a little bit more granularity on the launch I think you had mentioned you had reached about 500 accounts and third quarter and so this quarter have you grown that account base or was the growth primarily on reorder rates.

And given the good reception is there any thought to.

Further broadening the reach to new accounts or changing your strategy, especially in light of the oxy being delayed.

Avi I guess doing further investment and innovation on the pillar side and you having singular focus on <unk> right now do.

And the opportunity there to really lean into that and and brought in that and then separately on upper limb spasticity I know that you had cited that the safety and Tolerability was good.

Annabel Eva Samimy: Do you have any opportunity there to really lean into that and broaden that? And then separately, on upper limb spasticity, I know that you cited that the safety and tolerability were good, with no specific adverse events, but on cervical dystonia, you showed significant, or not significant, but actually meaningful improvement on some of the AEs that were problematic for cervical dystonia. Did you notice any of that for upper limb spasticity, just based on your formulation, potential better targeting of the neuromodulator? Thanks.

No specific aes, but on the cervical dystonia you showed.

Significant and were not significant but actually mean, a meaningful improvement on some of the aes that were problematic for for cervical dystonia did you notice any of that for upper limb spasticity.

And just based on your formulation potential better targeting.

Mark J. Foley: Thanks, Annabel. So, let me try and run through them. So first off, you know, we talked about at the end of Q3 being in roughly 500 accounts. In Q4, we said that between both HINT and RHA, we're in roughly 1,000 accounts. So clearly, our growth is going to come from a combination of reorder rates of existing accounts and new account ads. You know, we're trying to be very disciplined in our strategy. We're introducing this as a prestige or premium category for those accounts that see value in the program around this, not just the products.

The neuromodulator thanks.

Do you have a nice annabel so let me try and run through them. So first off.

Talked about at the end of Q3 being and roughly 500 accounts Q4, we said that between both <unk> and R. J. We're in roughly 1000 accounts. So clearly our growth is going to come from a combination of reorder rates <unk> rates of existing accounts and new account adds.

We're trying to be very disciplined and our strategy. We're introducing this as a prestige or premium category for those accounts and see value and the program around this and not just the products.

Mark J. Foley: But we obviously have a lot of conviction in the products as well. So we are targeting a subset of the overall aesthetic market. Historically, we talked about it being sort of the top end of the pyramid.

Obviously, a lot of conviction and the products as well, but so we are targeting a subset of the overall aesthetic market.

Frankly, we've talked about it being sort of the heart that the top end of the pyramid roughly a third of accounts are representing our target, but we want to be very measured without approach. So.

Mark J. Foley: Roughly a third of accounts are representing our target, but we want to be very measured with that approach. So kind of leading into your strategy of change, you know, any change around that? No.

And a leading into your strategy of change any change around that no. I mean, we continue to be very focused we think this is the right strategy for us both for fulfill.

Mark J. Foley: I mean, we continue to be very focused. We think this is the right strategy for us, both for the filler and for the neuromodulator side of things. And since Q4 was our first full quarter of launch, again, we're very early in terms of understanding reorder rates and dynamics. But, you know, even in the absence of DACI, if you think about it, we originally thought we would have the RHA filler line on the market in April of last year.

Historic and for the Neuromodulator side of things and so we continue to be very disciplined with that approach and.

Since Q4 was our first full quarter of launch again, we're very early in terms of understanding reorder rates and dynamics.

But even in the absence of Dachsie, if you think about it we originally thought we.

To fill our H a filler line on the market in April of last year that got pushed to September because of Covid delays from our manufacturer.

Mark J. Foley: That got pushed to September because of COVID delays from our manufacturer. And so, you know, we're continuing to focus on the launch and delivering the products, the RHA filler line, into the same accounts. And as we talked earlier, I think that, you know, the better job we do there, we're laying a great foundation for our neuromodulator once approved. I think on the CD side of it, I mean, on the ULS side of it, we saw a very clean safety profile. That's very consistent. I'll throw it over to Roman. Roman, I don't know if you want to add anything else on the safety side.

And so we're continuing to focus on the launch and delivering the products are H a filler line into the same accounts.

We would have and as we talked earlier I think that the better job, we do their ruling a great foundation for our neuromodulator once approved.

On the U L outside of it in terms of comparing it to C. D. I mean first off the CD trial, and we reported out was a phase III program. So much larger in scale and this sort of reduced phase III study.

And CD, obviously, one of the areas that generates a lot of concern as dysphasia.

Because if you inject too much and and patients have a difficulty in swallowing that can be a challenge. We were encouraged obviously by the data that we were able to generate I think on the CD side of it I mean on the <unk> side of it we saw a very clean safety profile.

That's very consistent and I'll throw it over enrollment and Roman and I know if you want to add anything else there on the safety side, yes, sure. So as Mark mentioned on the cervical dystonia side and the Aspen study. If we look at comparator trials and Dysphasia rate was and the mid to high teens, and we were able to demonstrate a similar.

Roman: Yeah, sure. So as Mark mentioned on the cervical dystonia side in the Aspen study, if we look at comparator trials, the dysphagia rate was in the mid to high teens, and we were able to demonstrate a similar, in the same category of dysphagia, an adverse event rate that was in the single digits, so approximately 4%. Unlike cervical dystonia in upper spasticity in adults, the adverse event rates across categories were already low. The AE rate of interest that would be an analog to dysphagia is weakness of the muscle, and there they have adverse event rates if you look at the other product inserts in the low single digits, low to mid single digits.

And the same category Dysphasia.

<unk>.

And adverse event rate that was and the single digit so approximately 4%.

Unlike circle cervical dystonia, dystonia, and upper limb spasticity and adults the adverse event rates across categories, we're already low.

And on AE rate of interest that would be and analog to dysphasia.

Okay.

We for southern muscle and there they have adverse event rates. If you look at the other product inserts and the low single digits low to mid single digits.

Roman: And we were very pleased to be able to have safety results that were also very strong in terms of low adverse event rates, including muscle weakness. So I would say that they were consistent in terms of what's been reported in the literature and equally low.

And we were very pleased to be able to.

Have safety results that were.

So very strong.

Asia is of low adverse event rates, including.

Muscle weakness, so I would say consistent.

In terms of what's been reported and the literature and equally low.

Roman: Thanks, everyone.

Annabel Eva Samimy: Thanks, Annabel.

Great. Thanks, Robert.

Thank you.

Balaji V. Prasad: Your next question is from Balaji Prasad from Barclays. Your line is open.

Your next question is from <unk> Prasad from Barclays.

Long and Turtle line is open.

Mark J. Foley: All right, thank you. Thanks for the questions.

And thank you and thanks for taking the questions maybe firstly a question on vaccines and cell while I appreciate that.

Mark J. Foley: Maybe firstly, a question on DAXA itself. While I appreciate that the approval launch looks a while away, have there been any conversations with the statisticians about COVID being a fundamental shift in how aesthetics are provided, especially toxins, patients or consumers not wanting to be visiting clinics frequently or not wanting to be in close proximity with the providers. And how much of a tailwind could this be for DAX when it eventually comes to the market? Would it be a question of the right product at the right time?

<unk> launched and it looks a while away.

Has there been any conversations with.

The solutions and above.

Covid being.

Fundamental shift and how is to take this provided especially.

Bulk since patients are consumers and I was wanting to be visiting cleaning frequently or.

And I was wanting to be in close proximity with the providers and how much tailwind could this be for <unk>.

About eventually comes onto the market would it be a question of the right product that I time.

Mark J. Foley: So Balaji, I think on that overall, and again, if we look, for example, at the HIN-MD platform, where we see some of the different volumes coming through the accounts, injectable volumes have actually been pretty good. There's no doubt that there are some markets that have been more impacted than others that have seen a more challenging recovery due to, you know, either consumers being less willing to engage or, frankly, some kind of getting out of the area.

For the block I think on that I mean overall and again, if we look for example to and MD platform, where we see some of the different.

Volume is coming through the accounts and.

<unk> volumes have been actually pretty good theres no doubt that.

And some markets that have been more impacted than others that have seen a more challenged recovery due to either consumers being less willing to engage or frankly, some kind of getting out of the area.

Mark J. Foley: But I think by and large, since the first shutdown occurred, a lot of these aesthetic practices have figured out how to operate in this environment, you know, through social distancing and safety protocols. And I think since a lot of consumers aren't traveling as much in their home and are looking at themselves on Zooms all day, people are finding ways to kind of get into their practices to get treatment. What has changed, as I mentioned, is I think the willingness of some of these accounts to engage with industry more broadly.

But I think by and large since the first shutdown occurred a lot of these aesthetic practices have figured out how to operate in.

There are higher but through social distancing and safety protocols and I think since a lot of consumers are traveling as much and are on arc home and are looking at themselves on zooms all day.

People are finding ways to kind of get into their practices to get treatment. What has changed as I mentioned is I think the willingness of some of these accounts to engage.

And this industry more broadly again, theyre, just sort of a drop by drop in and they want things to be a little bit more scheduled and.

Mark J. Foley: Again, they're just sort of drop-in and drop-out; they want things to be a little bit more scheduled, and just so that they can ensure that there is the right kind of environment there. I think to your question around, you know, would we see some sort of pent-up demand coming out of this once, you know, sort of, you know, people are immunized, and we've reached some level of herd immunity? I certainly could see that, right?

And just so that they can ensure that the right kind of environment. There I think for your question around would we see some sort of pent up demand coming out of this once.

The people are.

<unk>.

And within and we've reached some level of herd immunity.

And we could see that right I think that we believe that the underlying trends that existed pre COVID-19 will continue to prevail with younger people engaging people that are living longer and.

Mark J. Foley: I think that, you know, we believe that the underlying trends that existed pre-COVID will continue to prevail with, you know, younger people engaging; people that are living longer and wanting to retain sort of the best version of themselves want minimally invasive treatment. So we really like the overall growth characteristics of this market and would expect that we will see some pent-up demand.

And wanting to retain sort of the best version of themselves want minimally invasive treatment. So we really like the overall.

Is the growth characteristics of this market and would expect that we will see some pent up demand and I don't know dust and if you want to add anything to that I think I think you mentioned tailwind I think we see tailwind because of the lack of innovation and the market for so long right. So while COVID-19 environment that we look at <unk> I think people want treatments and last longer we've shown that studied and studied.

Dustin S. Sjuts: I don't know, Dustin, if you want to add anything to that.

Dustin S. Sjuts: I think you mentioned tailwinds. I think we see tailwinds because of the lack of innovation in the market for so long, right? So while COVID is the environment that we look at, Balaji, I think people want treatments to last longer. We've shown that study and study again, both done internally and externally, as you've shown. So we're excited to get it out in the market to give people an option for longer-lasting treatment. So we do think there are tailwinds, whether they're relative to COVID or not, I can't say, but people are ready for Daxibotulinum toxin for sure.

Overall, and both internally and externally as you've shown so we're excited.

To get out and the market to give people an option for longer lasting treatment. So we do think there is tailwind whether they are.

Relative to Covid or not I can't say, but people are ready for doxey botulinum toxin for sure.

Great.

Mark J. Foley: Great. Maybe a couple of other minor follow-ups. What's the latest update on Biosimilar Botox? What stage are you in? Has there been any progress during the quarter? Secondly, also, maybe in terms of fillers themselves, could you give us a sense of how many accounts you could plan to reach this year?

And then a couple of other minor follow ups.

What's the.

<unk> update on Biosimilar Botox and what stage are you and has there been any progress during the quarter.

Secondly, also maybe in terms of fillers and itself could you give us a sense of how many accounts.

And do it this year or each this year.

Mark J. Foley: So on the biosimilar, why don't I put that over to Oppai, and he can comment on that.

So and the Biosimilar why don't I put that over to off high and.

And he can comment on that.

Unknown Executive: Thanks Balaji. So, as you know, for Biosimilars, we are in a partnership with Viatrist, formerly called Mylan. That program is in the early development stage and is in collaboration with the two teams and progressing very nicely.

Yes, thanks for logic, so as you know that for a biosimilar beyond and our partnership with the interest for medical and in Milan.

And that program is and the early development stage and as.

The collaboration with <unk> and progressing very nicely.

Mark J. Foley: And in terms of the number of accounts, again, I just don't think, Balaji, we're at a position yet where we can, you know, give you that level of granularity. I think we're being very measured. You know, we talked about having roughly 100 reps out there. We talked about, you know, targeting the top third of the market. You know, we want to make sure that we are focused on those accounts that we think see value in a prestige product offering and that see value in the pricing strategy that we put in place.

Thanks, and then in terms of number of accounts again.

Our latest they still think blocked you were at a position yet where we can give you that level of granularity I think we're being very measured and we've talked about having roughly 100 reps out there we talked about we're targeting and the top third of the market.

We want to make sure that we are focused on those accounts that we think see value and our prestige product offering.

And Dave and the pricing strategy that we put in place and so we're going to be we're much more focused on being measured and going deep versus wide.

Mark J. Foley: And so we're going to be, we're much more focused on being measured and going deep versus wide. And certainly, as we get, you know, data points that we have conviction behind, we're happy to start sharing those with you.

And certainly as we get.

Data points that we have conviction behind and we will happy to start sharing those with you.

Mark J. Foley: Thank you, Mark. Thank you.

Thank you Mark Thank you.

Operator: Thank you.

Okay.

Your next question is from David.

Operator: Your next question is from David Amsellem on Piper Sander. Your line is open.

David <unk> from Piper Sandler Your line is open.

David A. Amsellem: Thanks. So, just a couple.

Yes.

So just just a couple for.

David A. Amsellem: First, on the ULS program, can you just talk about, I guess, the rough contours of what a Phase III program would look like, particularly in terms of the primary outcome measures and how that might differ from what you did in Phase II? And I apologize if I missed that, but I wanted to get some granularity on that. And then, secondly, in other therapeutic settings. I know, Mark, we've talked about migraine in the past. Any new color or thinking on your development plans for DAXI in migraine and when we may get an update there? Thanks.

First.

On the U L. S program can you just talk about.

I guess the rough contours.

A phase III program.

It would look like particularly in terms of the primary outcome measures and.

How that might differ from.

And what you did in the phase two.

And I apologize if I missed that but just wanted to get some granularity on that and then secondly, and other therapeutic settings I know Marc we.

Talked about migraine and the past any new color or thinking on your development plans for that Pete.

And migraine and when we May get an update there. Thanks.

Roman: Sure. For the first question, why don't I hand it over to Roman? You will have to answer your question in phase three.

Sure.

For the first question, one and I'll hand, it over to Rome, and Youll asset and so your question around phase III should remarks.

Roman: Sure, Mark. So, in terms of the phase 3 design, there are a few important points to consider. The first is, relative to the primary endpoint, In a similar way that other sponsors have landed on a co-primary endpoint that's based upon one objective and another subjective endpoint, namely, a modified ASHRA score on the objective side and an assessment of improvement on the functional side or the subjective side. In our case, it's a PGIC, or the Physician Global Impression of Change.

And so in terms of the phase III design. There are a few important points to consider the first is relative to the primary endpoint.

And a similar way that.

Other sponsors have.

Landed on a co primary endpoint is based upon one objective and and other subjective and point.

Okay.

Modified Ashworth score on the objective side and.

And assessment of improvement on the functional side or the subjective side and our case, it's a P J for the.

Physician global impression of change we would also just like we did and face to use those same two.

Roman: We would also, just like we did in Phase 2, use those same two co-primary endpoints, in discussion with FDA, and that would be our proposal. In addition, in terms of the overall design of the study, we would be looking to continue to evaluate safety, but also efficacy in terms of duration. So we would want to continue to follow patients all the way up to 36 weeks so that we can fully evaluate the long duration of our neuromodulator in this indication.

Name and primary endpoints.

And in discussion with FDA and that would be our proposal.

In addition in terms of the <unk>.

Overall design of the study we would be looking to.

Continue to evaluate the safety, but also the efficacy in terms of duration. So we would want to continue to follow patients. Although we have.

Two quick next week, so that we can fully evaluate the long duration of our neuromodulator in the syndication right and just to add on that day, and we would expect it to be two phase III programs, along with our open label safety study and those would be kind of a driving assumptions and this and then the details obviously it wouldn't be discussed as part of our end of.

Mark J. Foley: Yeah, just to add to that, David, we would expect these to be two phase three programs along with an open label safety study. Those would be kind of the driving assumptions in this, and then, you know, the details obviously would be discussed as part of our end of phase two meeting with the agency. So, you know, stay tuned for more on that later as we move forward.

As to meeting with the agency so state.

Stay tuned more on that later as we move forward then and your question on migraine I think this falls and that overall bucket of our therapeutic strategy and platform clearly we're furthest along in terms of the muscle movement disorder. The nice thing about that is.

Mark J. Foley: Then in your question on migraine, I think this falls in that overall bucket of, you know, our therapeutic strategy and platform. Clearly, we're furthest along in terms of the muscle movement disorder. The nice thing about that is, you know, both CD and adult ULS align around a central point in neurology. So it's very focused and targeted, and with the CD, you know, approval expected in 2023, that starts to move from being more of a commercial program to, you know, around the corner from being a commercial program, from a clinical to a commercial program.

Both CD and adult use.

Up to 30 align around a central point and neurology, so its very focused and targeted and with the CD.

Approval expected in 2023 that starts to move from being more of a commercial program to run.

And the corner to a commercial program.

From a clinical to a commercial program.

Mark J. Foley: Clearly, we recognize and see the value of the migraine market. It's, you know, a very large market, and as we kind of work our way through this data and this analysis, we'll be spending a lot of time working our way through exactly, you know, how much we do internally. Do we partner with any of it? How do we think about that long term? What I will say is, you know, the thing that we really like about our neuromodulator product is that it is sort of a pipeline and a product, right?

Lastly, we recognize and see the value of the migraine market.

Very large market and as we kind of work our way through this data and this analysis.

And we'll be spending a lot of time working our way through exactly how much do we do internally do we partner any of it how do we think about that long term what I will say is the thing that we really.

Like about our neuromodulator product is that it is sort of a pipeline and a product right. We can continue to access and turn on new markets as we invest in it and we just got to balance sort of those investments and a way that we think is thoughtful where we can make sure that we execute and deliver on the commercial line of things, while still having a really nice pipeline so as we.

Mark J. Foley: We can continue to access and turn on new markets as we invest in them, and we just got to balance those investments in a way that we think is thoughtful, where we can make sure that we execute and deliver on the commercial end of things while still having a really nice pipeline. So, as we have more and we work our way through the details of the therapeutics platform, we'll share that with you.

And we work our way through the details of the therapeutics platform, we'll share that with you.

Okay. Your next your next question is from Jacob Hughes from Wells Fargo. Your line is open.

Operator: Your next question is from Jacob Hughes from Wells Fargo. Your line is open.

Jacob Hughes: Hey guys, thanks for taking my question. Most of my questions have been answered, but I just had a follow-up question on the filler launch. I think you had a partial launch in the third quarter, and we saw what the numbers were in the fourth quarter. I think the static market has started to open up since then. So, I mean, are you able to parse out any COVID-related impact as we think about the first half of this year and then also longer term? I think P-Oxane had a high single-digit or low double-digit share in Europe without a neurotoxin. So how how are you thinking about the share now that you've been in the market? Thanks a lot.

Hey, guys. Thanks for taking my question.

Most of my questions have been answered, but I just wanted to follow up on the filler launch.

And I think you had a partial launch and the third quarter net.

And we saw what the numbers are and the fourth quarter and I think the static market has started to open up since then so.

For me are you able to parse out any.

Covid related impact as we think about the first half of this year and then.

Also longer term I think jocks and had.

High single digit or low double digit share and Europe without a neurotoxin so.

How are you thinking about the share now as.

You bet and the market. Thanks, a lot.

Mark J. Foley: Yeah, so great question. You know, in terms of the toxin share and ownership, I don't think anything's fundamentally changed. Clearly, COVID has, you know, created some additional challenges in the marketplace in terms of practices being able to be open and see patients, you know, whether or not patients are comfortable going into the practice. And then, as we mentioned earlier, some practices sort of restricting or limiting industry in an attempt to kind of control that environment.

Yeah. So.

In terms of the Trc, saying shared ownership I don't think anything's fundamentally changed clearly COVID-19 has created.

Some additional challenges and the marketplace in terms of practices being able to be open and see patients.

Whether or not and patients are comfortable going into the practice and then as we mentioned earlier some practices sort of.

Great quite limiting and industry in an attempt to kind of control that environment. So.

Mark J. Foley: So, you know, we think that as we come out of this, our ability to continue to, you know, drive our own share will kind of revert back to where it was pre-COVID. And it's just a question of where it gets us.

We think that as we come out of this that our ability to continue to.

Drive our own share.

And will kind of revert back to where it was pre COVID-19 and just the question of where it gets there in terms of the overall.

Mark J. Foley: In terms of the overall filler launch, again, it's hard to make any, you know, broad statements here, partly because we're very targeted in our launch, right? We are in 20,000 accounts where you can make some general statements about the market. You know, we definitely have some headwinds in terms of, you know, you've got COVID. Access is a little harder.

Strict and <unk> launch.

Again, it's hard to make any broad statements here, partly because we're very targeted and our launch right and we arent in 20000 accounts, where you can make some general statements about the market. We've got we definitely have some some headwinds in terms of you've got COVID-19.

Access.

It is a little harder.

Mark J. Foley: You know, you've got some quarter over quarter seasonality that's different, you know, Q4 being big, Q1 being sort of the lowest quarter. But we're also in a launch phase, right? And so we're opening up new accounts as we move forward, which in some ways, you know, allows us to mitigate some of those challenges in the market. But since we're only one quarter in, I think it's just really hard for us to make any commentary or statements that are overall representative.

<unk> got some.

<unk> over quarter seasonality, that's different and Q4 being big Q1, being sort of the lowest quarter, but we're also and a launch phase right and so we're opening up new accounts as we move forward, which in some way allows us to mitigate some of those challenges and the market, but since we're only.

<unk> order and I think it's just really hard for us to make any commentary or statements that our overall representative I think we need a little bit more time to again gather sort of reorder rates and profile again, we're very committed to this strategy of being targeted versus just trying to open up any accounts we can.

Mark J. Foley: I think we need a little bit more time to, again, gather sort of reorder rates and profiles. Again, we're very committed to the strategy of being targeted versus just trying to open up any account. We continue to think it's the right strategy. So, you know, Jacob, as we have a little bit more color and clarity into this, we'll certainly be sharing some of that.

Continue to think it's the right strategy, so you'll Jacobs.

And <unk> been a little bit more color and clarity and this will certainly be sharing some of that yes, I think the only thing I would mention is that we really are getting strong feedback and the clinical profile and the products not just one but all three of those products and I think that speaks to the foundation and <unk> was able to generate outside the United States, depending on market share and what have you, but it means that it can clinically standup.

Dustin S. Sjuts: Yeah, I think the only thing I would mention is that we really are getting strong feedback on the clinical profile of the products, not just one, but all three of those products, and I think that speaks to the foundation that Teoxin was able to build outside the United States. Depending on market share, what have you, but it means that it can clinically stand up on its own, and we're seeing that in the U.S. as well.

Up on its own and we're seeing that and the U S. As well too so that gives us a lot of great Foundation to now a couple of round with that clinical foundation, the training and marketing efforts and and the portfolio products within <unk> and eventually to actually botulinum. So we feel really good about the clinical profile and our IHA, one as well and with IHA one coming at the end of this year with potential.

Dustin S. Sjuts: So that gives us a great foundation to now couple with that clinical foundation, the training, the marketing efforts, and then the portfolio products with HintMD and eventually Daxibotulinum. So we feel really good about the clinical profile of RHA-1 and its potential approval at that time.

Approval at that time.

Dustin S. Sjuts: Thanks, guys.

Thanks, guys. Thanks Jacob.

Jacob Hughes: Thanks, Jacob.

Operator: Your next question is from Tim Lugo from William Blair. Your line is open.

Your next question is from Tim Lugo from William Blair. Your line is open.

Timothy Francis Lugo: Thanks for taking the questions, and maybe just one housekeeping question before another similar question. For ULS, you mentioned the $620 million global opportunity in 2020. How much of that is in the U.S., not global, and do you know a growth rate for that?

Thanks for taking my question and then maybe just one housekeeping question before and other similar questions.

For U L. S. You mentioned.

And the $620 million global opportunity in 2020, how much of that is in the U S non global and <unk>.

And our growth rate.

Tobin C. Schilke: I don't have the breakdown, but the majority of it is typically in the United States. I don't have the specific breakdown. The growth rate, we talked about it growing to about a billion dollars in time, but I'll get you the specifics as a follow-up.

Okay.

Don't have that.

And I don't have the breakdown majority of its typically in the United States and don't have the specific breakdown and the growth rate, we talked about and.

Growing to about $1 billion.

And time, but I guess, you the specifics and the follow up.

Unknown Executive: Okay, no problem. Thank you for that.

Okay No problem, thank you for that and.

Dustin S. Sjuts: And just going back kind of broadly to your further launch, it's obviously a premium product, and you're being targeted in your launch, but can you give us an idea of the type of discounting you're seeing? Is this more aggressive because a new premium product is being launched into the market? Or is this the kind of everyday discounting you're seeing from tertiary market players? And then, are you also seeing spillover into discounting of neurotoxins? I know you obviously don't have DAXI in the market yet, but I'm just wondering how these market dynamics might change once DAXI is approved.

And just going back kind of broadly to your further launch it's obviously a premium product and you have been targeting new launch, but can you give us an idea of the timing.

Discount and Youre seeing is this more.

Aggressive because our new premium product is being launched into the market or is this the kind of every day discounting you're seeing from tertiary market players.

And then are you also seeing spillover into discounting of Neurotoxins I know you, obviously don't have the axiom and the market yet right.

And just wondering how these market dynamics might change once taxi is approved.

Dustin S. Sjuts: That's a good question. I think from the discounting perspective, the competitive landscape in this environment is pretty entrenched with large competitors that kind of have a strategy that they put in place, and they kind of put it into play. So you're seeing large amounts of coupons and combination treatments being launched in the fourth quarter, as you typically would see from some of the large players. You're also seeing the same thing around individual new product launches around consumer coupons and really trying to drive that patient into the practice via couponing.

It's a good question I think from a discounting perspective, the competitive landscape in this environment is pretty entrenched and large competitors and kind of have a strategy that we've put in place and they kind of.

Put into place so you're seeing large amounts of coupons and combination treatments being launched.

Launched in the fourth quarter as you typically would see from some of the large players you're also seeing.

The same thing.

<unk> individual new product launches around consumer coupon and really trying to drive that.

And that patient into the practice of couponing, So I haven't seen it change dramatically with the entrant I think youre seeing kind of an increase.

Dustin S. Sjuts: I haven't seen it change dramatically with the new entrant. I think you're seeing kind of an increase in just the overall approach and focus on specific products and try how you're balancing it with fillers. Will it change with DAXI? Time will tell. I think the unique thing about DAXI is that it's not as price-dependent because it provides something to both the consumer and the provider that no other product in the

And just overall approach and focus on specific products and trying to how you are balancing it with pillars will change with taxi time will tell I think the unique thing about <unk>, it's not as price dependent because it provides something for both the consumer and the provider and know their product and the space has and so we find that whether you're offering something else cheaper that may not be enough.

Dustin S. Sjuts: And so we find that whether you're offering something else cheaper, that may not be enough to get that patient or that physician to not use DAXI botulinum. So we feel very good about that once we get in the market.

To get that patient or that physician to not used actually botulinum. So we feel very good about that and.

And once we get in a market and we have not seen any and what I would say knee jerk responses in terms of reaction. It's early and with Covid I think everybody is trying to figure out exactly.

Timothy Francis Lugo: I'm not seeing any, what I would say, knee-jerk responses.

Operator: At the end of the day, it's a really good question. It's early,

Serge D. Belanger: And with COVID, you know, I think everybody's trying to figure out exactly where to kind of place their bet. What's also unique about today is that, as you know, this market is hard to segment. You've got thousands of customers all acting as independent types practices. We're seeing even more segmentation and market dependency. You've got some cities that are open and allowing certain things. You've got some practices that have different types of protocols. So it's been hard to kind of trend all of that out in a typical aesthetic market.

And where do you kind of place their bets. What's also unique about today is that this market is hard to segment as you know.

No.

Got thousands of customers all acting as independent type practices, we're seeing even more segmentation and market dependents that you've got some cities that are open and allowing certain things you've got some practices that have different type of protocols. So it's been hard to kind of trend all of that out and a typical static market. So hope that answers your question.

And it does thank you.

Tobin C. Schilke: It does. Thank you.

And.

Unknown Executive: Your next question is from Serge Belanger from Needham & Company. Your line is open.

Your next question is from search Bellinger from Needham and company. Your line is open.

Serge D. Belanger: Good afternoon, just a couple questions for me. First one for Tobin, can you just go through some of the push and pulls behind the off X guidance for this year?

Yes.

Hi, Good afternoon, just a couple of questions for me first one for for Toby and can you just go through some of the push and pulls behind the Opex guidance for.

Serge D. Belanger: ...

Unknown Executive: I believe... Muscle movement disorders make up about 40-45% of the overall therapeutic potential of neuromodulators. How much does cervical dystonia and ULS cover of that piece of the pie? And then lastly, I think earlier this month, the FDA scheduled an advisory committee meeting to discuss the risk and benefits of dermal fillers. Just wondering if you'll be presenting there and maybe what your thoughts are on what the FDA wants to accomplish with this advertising campaign. Thank you.

For this year.

And then secondly.

I believe.

Yeah.

Muscle movement disorders, and make up about 40% to 45% of the overall <unk>.

<unk>.

Potential and Neuromodulators.

How much this cervical dystonia and <unk> cover.

<unk>.

Of the piece of the pie.

And then lastly, I think earlier this month, the FDA scheduled and AD com to discuss the risks and benefits of dermal fillers.

Just wondering if you'll be presenting there and maybe what are your.

For us on what the FTE.

And he wants to accomplish for the Satcom.

Tobin C. Schilke: Hey Serge, this is Toby. Thanks for the questions. With regard to the push-pulls on OPEX, you know, it appears on the surface that the non-GAAP research and development expenses are flat from 2020 to 2021, and that flatness is driven by the inclusion of HINT-MD. If it wasn't for HINT, the R&D expenses would be lower year on year, and that's driven by lower clinical activity. If you recollect, we had seven clinical trials in the year 2020, and now we're running two clinical trials in 2021, and also a slight full-year effect of the HINT-MD commercial efforts as well. That's sort of the high-level pushes and pulls on OPEX.

Thank you.

Hey, Serge this is Toby and thanks for the questions.

With regards to the push and pulls on Opex.

No.

It appears on the surface that the non-GAAP research and development expenses are flat 20.

<unk> 'twenty to 'twenty 'twenty, one and that's that flatness is driven by the inclusion of hint M. D. If it wasn't for the R&D expenses would be lower year on year, and that's driven by lower clinical activity. If you recollect, we had up 7%.

We'll trials in the year 2020, and now we're running two clinical trials and 21.

Further further on.

Our SG&A expense, which makes up the balance of the Opex there.

Unknown Executive: So the next question is on the breakdown. I think what we have stated here is that the combination of total spasticity was $620 million and is going to be a billion dollars by 2025. For the breakdown, these are kind of hard markets to break down being that the, the, the, our orphan diseases and others that are hardest to parse out. So when we get to you, we can follow back up with.

Is up year to year, driven by sort of the full.

Full year effect of the 100 person field force that we hired and then estimates for.

Kind of continued push on both the filler and toxin there and also a slight full year effect of the hint MD commercial efforts.

Parts as well.

And sort of the high level of pushes and pulls on Opex.

Great.

So the next question is on the breakdown I think and we have stated here is that the combination of total spasticity with $620 million.

Unknown Executive: And then your last one on the ad comm; we're not planning to participate in that.

And going to $1 billion by 2025 for the breakdown. These.

Unknown Executive: Got it. Okay. Thank you.

Or kind of hard markets to break down being that that is the.

Operator: There are no more questions at this time, and we'll touch base with HSE Wainwright and Mizzou offline. I would now like to turn the conference back to you, Mark.

<unk> orphan diseases, and others that are part of it.

And that are hard to parse out so we'll be getting and we can follow back up with those specific.

And then your last one on the AD com, we're not planning to participate in that.

Got it okay. Thank you.

Mark J. Foley: Great. Thank you, Operator.

And then.

There are no more questions at this time, and we'll touch base with HC Wainwright and Mizuho offline I would now like to turn the conference back to you Mark.

Operator: In the coming months, we plan to virtually attend the Cowan, Barclays, and Needham Healthcare Conferences. We welcome your requests for meetings at these events or directly through us. Feel free to reach out to Jessica if you'd like to schedule some time. With that, I would like to thank all of you for participating in today's call.

Great. Thank you operator, and the coming months, we plan to virtually and the Cowen Barclays and Needham Health care conferences. We welcome your requests for meetings at these events are directly through us feel free to reach out to.

Jessica if you'd like to schedule some time with that I would like to thank all of you for participating in today's call.

Operator: Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. Have a wonderful day. You may all disconnect.

Ladies and gentlemen. This concludes today's conference call. Thank you for your participation and have a wonderful day you may all disconnect.

Operator: BF-WATCH TV 2021

Okay.

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