Q3 2020 Revance Therapeutics Inc Earnings Call

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Welcome to the web site.

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Oh quite a 21.9 so.

Financial results and corporate update conference call.

At this time all participants are in a listen only mode.

Oh Man management.

Our prepared remarks, we will hold it you any session.

Lots of questions at that time, Please press star followed by one on your Touchtone phone.

If anyone has difficulty hearing a complaint please press star zero for operator assistance.

As a reminder, this call is being recorded today November 920 20.

I would now like to turn the conference over to Jeanie Herbert head of Investor Relations for Revance. Please.

Please go ahead.

Excuse me joining us on the call today from advance, our President and Chief Executive Officer, Mark Foley, Chief Financial Officer, Tobi, Ltke, Chief operating officer, and President of R&D and chronic operations Dr. off high Josie Chief Commercial officer Therapeutics Anesthetics Dustin suit.

President of innovation technology, Opry ranking and senior Vice President clean and clinical development Dr.

Roman Rubio.

Earlier today were dance released financial results for the third quarter ended September Thirtyth 2020, and topline results from the phase two trial of Daxibotulinumtoxina for injection in plantar fasciitis, if you've not received these news releases or you would simply like to be added to the copies distribution list to receive future.

Leases. Please go to the Investor Relations section of the revamped website, which can be found at www dot revamps Dot com.

This conference call management will make forward looking statements, including statements related to read them says 2020 financial results and guidance the current and anticipated clinical development of our product candidates.

Our business strategy and planned operations anticipated pre commercialization launch plan the timing of any potential approval of Jackson's botulinum toxin neighbor injections by the FDA financial estimates the range and degree of commercial acceptance potential market size opportunity and growth with respect to the.

Sorry, Jay collection of dermal fillers and the interim de fin Tech platform and our product candidate if approved.

And our financial outlook milestone expectations and expected cash runway and financial performance.

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 entitled Risk factors in our current report on form 10-Q to be filed this afternoon November nine 2020 for vans cautions you not to place undue reliance on forward looking statements and undertakes no duty or obligation to update any.

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, which management believes are helpful to investors to evaluate our recurring operational performance a reconciliation of non-GAAP to GAAP measures is included in our.

Our earnings release, which is available on our Investor Relations website at investors Dot Revamps dotcom.

The non-GAAP financial measures should be considered in addition to results prepared in accordance with GAAP, but should not be considered a substitute for or superior to GAAP results with that I will now turn the call over to more fully.

Mark. Thank you Jeannie welcome to rebalance Therapeutics third quarter 2020.

Financial results conference call.

This has been a transformational year revamped despite the challenging environment, resulting from the COVID-19 pandemic.

In addition to achieving most of our 2020 milestones we diversified our statics franchise with two strategic transactions significantly enhanced our cash position reported out compelling clinical data across several phase two and phase three programs and transition to a commercial enterprise.

In Q3, we successfully launched the Rhj collection of dermal fillers and hit MD Fin Tech platform to the statics market and we are encouraged by the early traction we.

We believe that our success to date reflects the strength of the portfolio, we've assembled the quality of our sales organization and our prestige market positioning.

We've also laid a strong foundation for our therapeutic franchise with the recently reported Aspen one phase three results in cervical dystonia.

In a moment I'll touch on are being placed us and will also go into more detail on our therapeutic franchise, but before I do let me hand, the call over to Dustin suits, our chief commercial officer to share with you more details regarding the strong start to our commercial launch duston. Thank.

Thank you Mark as a third quarter Revanchist officially made the leap from clinical to commercial stage. We're very encouraged with the early results of the commercial launch and the responses from our customers to the RJ collection and his MD platform as such I am proud to announce that we generated 3 million of sales from products and services.

In our first partial commercial quarter the high enthusiasm around the launch gives us great confidence numbers and for Vance has assembled the right products and team.

In early September we established the if we established an officially introduce romances statics the overarching customer facing brand for our Fedex portfolio. Our mission is to give customers an exquisite experience across our product and services portfolio.

There have answered static portfolio includes one the RJ collection, the first and only hyaluronic acid filler ft approved for dynamic wrinkles unfolds. This designer filler resembles the skin natural hyaluronic acid and was curated to adapt to facial movement.

To help them be fintech platform, the aesthetic industry's first payments subscriptions and loyalty platform engineered to transform aesthetic practices with tailored financial technology and finally upon approval, we will add the highly anticipated daxibotulinumtoxina for injection, which is.

Under review at the FDA for the treatment of Glabellar lines turn.

Turning to the launch of the RJ collection in the third quarter, we completed our preview early clinical education and experience program.

Establishments romance, you, our premier injector training and education platform.

Created and tested clinical messaging position for this it positioning and engagement programs with physicians across the country.

And launch the RJ collection flawless in motion campaign hosting nearly 30 National beauty media editors and exclusive virtual event with Dr. Abraham ban founder and CEO of T. Oxiclean Madam Valerie coupon and New York Times Best selling offer author an Emmy Award winning television personality Kelting Knight General.

Being more than 18 million impressions.

We hired our 100 plus field force and completed sales force training necessary to launch the risk revamped aesthetics portfolio and successfully integrated the hit to be organization consolidating into one customer facing business unit within aligned vision.

Results from all these initiatives have been positive setting the foundation for the successful launch of anesthetics.

The preview program consisted of more than 100, leaving a static injectors, we treated approximately 1000 patients with the RJ collection.

Nearly 3000 surrendered syringes of the RJ collection inclusive of already Ceight, two three and four were administered to a variety of patients, which helped to inform and enhance our education materials.

More than 97% of physicians indicated that the results of the Rhj collection looked both natural while at rest and in motion.

True value and our sales team, we have trained more than 600 injectors across the country to date. Despite the evolving cobot landscape. Our team has leveraged face to face training efforts as well as a virtual training utilizing seven highly experienced trainers from across the globe to provide an interactive training.

Experience.

In August we successfully and safely hosted romances first commercial launch meeting with live training for 100, plus person sales force setting a standard for future live events required to commercially launch both the company and a collection of new products and services.

As for our results in September we began selling the RJ collection in the head MD platform in select accounts in the U.S. with initial launch activities generating 3 million in revenues in the third quarter across less than 500 customer accounts.

We are seeing orders across all three product SK use our HSV two three and four reinforcing that all three products serve distinct needs.

Turning to our Fintech platform with the integration of hint MD, we're positioned with a truly unique portfolio in the last week. We are pleased to report that hints MD has processed $100 million in payment processing to date in 2020.

Our initial strategic focus is to offer incremental value to practices to payment processing with touchless smart payments. While we are in the process of prioritizing our platform development pipeline. Our goal is to deliver an even better user experience with industry first features such as a white label loyalty program and an exciting pace.

One facing facing subscription experience.

As for Daxibotulinumtoxina for injection anesthetics, having announced topline results in June from our informative phase two trials in four headlines and separately crow's feet, we remain poised to announce topline results from our phase two open label study and upper facial lines in December the results from these open labels.

Ladies will further inform future aesthetic development programs.

In terms of the market and access to customers.

Total injectables continue to be in high demand and players active in the industry are reporting a V shaped revenue recovery with many returning to pre cobot levels.

Both plastic surgery and dermatology practices are reporting strong demand for procedures led by facial injectables.

We're finding most practices have adapted to the evolving cobot environment.

Operator: Welcome to the Reverend 3rd Quarter 2020 Financial, Financial Results, and Corporate Update Conference Call. At this time, all participants are in a listen-only mode.

Across the portfolio and across the country. Our sales team has had access to customers both face to face and virtual with more than two thirds of interactions being held safely in person level.

Leveraging the unique power of data across the hints in the platform, we were able to keep our finger on the pulse of the aesthetics market interestingly payment processing over March and April decreased 64% compared to the prior five month average. However, we saw a sharp recovery in may up 33%, a trend which continued.

Operator: Following management's prepared remarks, we will hold a Q&A session. To ask questions 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, November 9, 2020. I would now like to turn the conference over to Ginny Herbert, Head of Investor Relations for Revenge. Please go ahead.

Through Q3.

Within plastic surgery practices payment processing levels reached the strongest month on record.

Overall, we are very pleased with our initial launch of the RJ collection and the entity platform in the US we deployed a trained sales force integrated the hinton be offering engaged world renowned experts to train our us physicians and executed on the prestige strategy, which has led to strong initial sales performance the earth.

Ginny Herbert: Thank you, Daphne. Joining us on the call today from Revance are 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 Therapeutics and Aesthetics Dustin Sjuts, President of Innovation and Technology Aubrey Rankin, and Senior Vice President Clinical Development Dr. Roman Rubio. Earlier today, Revance released financial results for the third quarter ended September 30, 2020, and top-line results from the Phase II trial of Daxi botulinum toxin A for injection in plantar fasciitis. If you have not received these news releases or you would simply like to be added to the company's distribution list to receive future releases, please go to the Investor Relations section of the Revance website, which can be found at www.revance.

Unknown Executive: During this conference call, management will make forward-looking statements, including statements related to Revance's 2020 financial results and guidance, the current and anticipated clinical development of our product candidates, our business strategy and planned operations, anticipated pre-commercialization and launch plans, the timing of any potential approval of Daxifotulinum toxin A for injections by the FDA, financial estimates, the range and degree of commercial acceptance, potential market size, opportunity, and growth with 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.

The yields have bolstered our confidence in our people products and strategy with that I'll now turn the call back over to Mark.

Thanks Dustin.

Now, let me address the potential for a delay to our approval associated with our outstanding late submission for Daxibotulinumtoxina for injection in Glabellar lines, which we shared in our third quarter financial release.

Unknown Executive: Factors that could cause results to be different from these statements include factors the company describes in the section entitled Risk Factors in our current report on Form 10-Q to be filed this afternoon, November 9, 2020. Transcripts provided by Transcription Outsourcing, LLC. Also on today's call, we will present both GAAP and non-GAAP financial measures, which management believes are helpful to investors to evaluate our recurring operational performance. A reconciliation of non-GAAP to GAAP measures is included in our earnings release, which is available on our investor relations website at investors.revance.com. The non-GAAP financial measures should be considered in addition to results prepared in accordance with GAAP but should not be considered a substitute for or superior to GAAP results.

As reported by several biotech companies. The FDA has been delaying some site inspections in corresponding drug approvals due to covert related travel restrictions.

With just 16 days to go until our previously announced PDUFA date of November 25th we felt it was appropriate to provide an update on our status as of today. The FDA has yet to schedule a site inspection of our US based manufacturing facility in Newark, California the.

The agency as previously noted that a site inspection is required prior to approval of our ballet.

The FDA has also communicated that their ability to conduct inspections is limited based on their COVID-19 related guidance and travel restrictions currently in place.

Well, there's still a chance that an inspection could be conducted prior to November 25, we wanted to acknowledge the possibility that our drug might not be approved on our PDUFA date at.

At this time, we do not have any additional information and do not plan to elaborate further we continue to work proactively with the agency to secure and inspection at the earliest possible time.

With the strategic transactions, we made earlier this year of the RLJ collection in Hindi platform revamped is more diversified than ever before and less dependent on any single revenue stream.

Grievances cash guidance remains unchanged as we continue to project that the company is funded into 2023 due to the puts and takes associated with a new product launch.

Should we have a delay to our FDA approval. We believe the company is in an excellent position, both commercially and financially to weather any change to the timing for the potential approval.

We also remain confident in the overall strength of our BLA submission and we'll continue to work proactively with the agency to complete the necessary site inspection.

Now, let me turn to our therapeutics franchise.

We were thrilled to announce in October the positive results from our asking one phase III pivotal trial of Daxibotulinumtoxina for injection in the treatment of cervical dystonia, which we believe will underpin the next stage of growth for rebounds beyond the statics.

The Aspen one trial met its primary endpoint and secondary endpoints across cross both doses with high statistical significance in the study revealed a potentially differentiated safety profile with a long duration of effect of 24 weeks.

Importantly, we were able to deliver these results with a low dose of active neurotoxin with low adverse event rates, particularly as it relates to dysphasia and muscle weakness.

Mark J. Foley: With that, I will now turn the call over to Mark Foley. Thank you, Jeanne. Welcome to Revance Therapeutics' third quarter 2020 financial results conference call. This has been a transformational year at Revance, despite the challenging environment resulting from the COVID-19 pandemic. In addition to achieving most of our 2020 milestones, we diversified our aesthetics franchise with two strategic transactions, significantly enhanced our cash position, reported compelling clinical data across several Phase 2 and Phase 3 programs, and transitioned to a commercial enterprise. In Q3, we successfully launched the RHA collection of dermal fillers and HintMD FinTech platform into the aesthetics market, and we are encouraged by their early traction. We believe that our success to date reflects the strength of the portfolio we've assembled, the quality of our sales organization, and our prestige market positioning.

Dustin S. Sjuts: We've also laid a strong foundation for our therapeutics franchise with the recently reported Aspen 1 Phase 3 results in cervical dystonia. In a moment, I'll touch on our BLA status, and we'll also go into more detail on our therapeutics franchise. But before I do, let me hand the call over to Dustin Sjuts, our Chief Commercial Officer, to share with you more details regarding the strong start to our commercial launch.

We believe that being able to potentially reduce the number of treatments along with corresponding practice visits by up to 50% a year is meaningful to patients caregivers physicians and payers alike.

Based on these results doxey botulinum toxin a projection could represent a material advancements in cervical dystonia care and result in significant pharmacoeconomic savings.

The Aspen, but well EPS for open label safety study for cervical dystonia continues with results expected in 2021.

Accordingly, we are aiming for regulatory approval for our first therapeutic indication in 2023.

Let me remind you that cervical dystonia is a $340 million market sizable in and of itself, but only a portion of the $2.3 billion global therapeutic market for botulinum toxin.

In addition to cervical dystonia, we're pursuing and other muscle movement disorder upper limb spasticity and plan to report results from the Juniper phase two trial in the first quarter of 2021.

Which brings me to today's plantar fasciitis results in.

In conjunction with our third quarter earnings release. This afternoon, we announced results from our phase two trial of Daxibotulinumtoxina for injection for the management of plantar fasciitis, a painful affliction of the foot.

Dustin S. Sjuts: Thank you, Mark. As of the third quarter, Revance has officially made the leap from clinical to commercial stage. We are very encouraged by the early results of the commercial launch and the responses from our customers to the RHA collection and HINT MD platform. As such, I am proud to announce that we generated $3 million in sales from products and services in our first partial commercial quarter.

In the trial, but the 80 unit and 120 unit doses resulted in measurable pain relief that was numerically greater than to see though on the numeric pain rating scale. However.

Dustin S. Sjuts: The high enthusiasm around the launch gives us great confidence that Revance has assembled the right products and team. In early September, we established and officially introduced Revance Aesthetics, the overarching customer-facing brand for our aesthetics portfolio. Our mission is to give customers an exquisite experience across our product and services portfolio. The Revance Aesthetics portfolio includes, one, the RHA collection, the first and only hyaluronic acid filler FDA-approved for dynamic wrinkles and folds. This designer filler resembles the skin's natural hyaluronic acid and was curated to adapt to facial movement on the HintMD FinTech platform, the aesthetic industry's first payments, subscriptions, and loyalty platform Engineered to Transform Aesthetic Practices with Tailored Financial Technology.

However, neither dose met the primary efficacy endpoint of statistically significant improvement in the NP Rs per foot pain at week, eight when compared to placebo.

Thank you bought your line and talked today for injection appeared generally safe and well tolerated when injected into the foot.

No. Other neuromodulator has been approved for the treatment of plantar fasciitis. So we were attempting to stake out a first mover advantage in a new therapeutic category with underlying physiology that is different from existing muscle movement for pain disorders, but.

And we plan to further analyze the data our primary focus will be on indications, where the market and pass through approval, our well established for Neuromodulators.

Now with the strong phase three cervical dystonia data, we can advance our initial commercial planning and therapeutics and we're looking forward to reporting the juniper phase two clinical results for upper limb spasticity in the first quarter of 2021.

Dustin S. Sjuts: And finally, upon approval, we will add the highly anticipated Daxibotulinum Toxin A for injection, which is under review at the FDA for the treatment of gabellar Lyme. Turning to the launch of the RHA collection, in the third quarter, we completed our preview early clinical education and experience program. Establish Revance U, our premier injector training and education platform. Created and tested clinical messaging, positioning, and engagement programs with physicians across the country, and launched the RHA Collection Flawless In Motion campaign, hosting nearly 30 national beauty media editors for an exclusive virtual event with Dr. Ava Shamban, founder and CEO of Teoxane, Madam Valerie Topan, and New York Times best-selling author and Emmy award-winning television personality, Kelty Knight, generating more than 18 million impressions.

Combined these results will help us formulate our clinical strategy and therapeutics going forward.

With that I'll now turn the call over to Toby showcased to cover the financials.

Thank you Mark starting with our cash cash equivalents and short term investments balance we ended the third quarter with $436 million, which we believe is sufficient to fund our planned operations into 2023.

Revenue for the third quarter of 2020 consisted of $3.8 million, which primarily represents initial orders of our ha collection of dermal fillers you will note that our revenues are now broken out into three categories on the income statement.

During the quarter product revenues from the Rhj collection was $2.8 million collaboration revenues from our Milan partnership was zero point $8 million and services revenue from the hint MD platform was zero point $2 million.

Dustin S. Sjuts: We hired our 100-plus field force and completed sales force training necessary to launch the Revance Aesthetics portfolio and successfully integrated the Hint&Be organization, consolidating into one customer-facing business unit with an aligned vision. The results from all these initiatives have been positive, setting the foundation for the successful launch of Revance Aesthetics. The Preview Program consisted of more than 100 leading aesthetic injectors who treated approximately 1,000 patients with the RHA collection. Additionally, nearly 3,000 syringes of the RHA collection, inclusive of RHA 2, 3, and 4, were administered to a variety of patients, which helped to inform and enhance our education materials. More than 97% of physicians indicated that the results of the RHA collection looked both natural while at rest and in motion.

For the third quarter, our operating expense was $81 million, excluding the cost of revenue depreciation and amortization stock based compensation and the RLJ related in process R&D, our operating expense was $65.4 million.

The earnings release, we issued today outlines our financial results in full so I will not go through the details on this call.

In terms of our Twentytwenty outlook GAAP operating expenses, including the effects from the hint MD acquisition is expected to be $285 million to $295 million non-GAAP operating expense remains in the range of $220 million to $230 million.

Dustin S. Sjuts: Through Revance U and our sales team, we have trained more than 600 injectors across the country to date. Despite the evolving COVID landscape, our team has leveraged face-to-face training efforts as well as virtual training utilizing seven highly experienced trainers from across the globe to provide an interactive training experience. In August, we successfully and safely hosted Revance's first commercial launch meeting with live training for 100-plus person sales, setting a standard for future live events required to commercially launch both a company and a collection of new products and services.

This excludes the cost of revenue depreciation amortization stock based compensation and the rhj related in process R&D.

We continue to expect our Twentytwenty non-GAAP non hint Mds research and development expense to be $95 million to $100 million.

In terms of future revenue our policy remains to refrain from providing sales guidance until we can determine the launch trajectory of our AJ collection and MD platform.

Dustin S. Sjuts: As for our results, in September, we began selling the RHA collection and the HintMD platform in select accounts in the U.S., with initial launch activities generating $3 million in revenues in the third quarter across less than 500 customer accounts. We are seeing orders across all three product SKUs, RHA 2, 3, and 4, reinforcing that all three products serve distinct needs. Turning to our fintech platform, with the integration of HintMD, we are positioned with a truly unique portfolio. In the last week, we are pleased to report that HintMD has processed $100 million in payment processing to date in 2020.

Finally for advances shares outstanding as of October 32020 were approximately 66.5 million shares was 72.4 million shares on a fully diluted basis, excluding the impact of convertible debt.

And with that I will turn the call back over to Mark.

Thank you Tobey Revance is building a powerful aesthetics franchise and has now demonstrated through our positive aspect one cervical dystonia results the companys potential to create a similarly strong franchise in therapeutics import.

Importantly, we are entering established markets, where the combined $6 billion worldwide armed with the next generation of products and services.

Dustin S. Sjuts: Our initial strategic focus is to offer incremental value to practices through payment processing with touchless smart payments while we are in the process of prioritizing our platform development pipeline. Our goal is to deliver an even better user experience with industry-first features such as a white-label loyalty program and an exciting patient-facing subscription experience. As for daxibotulinum toxin A for injection in aesthetics, having announced top-line results in June from our informative phase two trials in four headlines and separately Crow's feet, we remain poised to announce top-line results from our phase two open-label study in upper facial lines in December. The results from these open-label studies will further inform future aesthetic development programs.

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

Absolutely.

In order to ask a question press star well number one on your telephone keypad.

[music].

Your first question comes from the line Mark can support with Cowen and company.

So with our our ha and.

And just along the lines of taxi Mark I don't know if you'd just characterize for US where you stand outside of the manufacturing inspection do you feel you are far along with the rest of the review are you kind of engaged in a label at this point. So any color you could provide there would be great.

Dustin S. Sjuts: In terms of the market and access to customers, facial injectables continue to be in high demand, and players active in the industry are reporting a V-shaped revenue recovery, with many returning to pre-COVID levels. Both plastic surgery and dermatology practices are reporting strong demand for procedures led by facial injectability. We're finding that most practices have adapted to the evolving COVID environment. Across the portfolio and across the country, our sales team has had access to customers both face-to-face and virtual, with more than two-thirds of interactions being held safely in person. Leveraging the unique power of data across the HintMD platform, we were able to keep our finger on the pulse of the aesthetics market. Interestingly, payment processing over March and April decreased 64% compared to the prior five-month average.

Dustin S. Sjuts: However, we saw a sharp recovery in May of 33%, a trend which continued through Q3. Furthermore, within plastic surgery practices, payment processing levels reached the strongest months on record. Overall, we are very pleased with our initial launch of the RHA collection and the HintMD platform in the U.S. We deployed a trained sales force, integrated the HintMD offering, engaged world-renowned experts to train our U.S. physicians, and executed on the Prestige Strategy, which has led to strong initial sales... The early yields have bolstered our confidence in our people, products, and strategy. With that, I'll now turn the call back over to Mark.

And then second question as we think about eventual approval and launch there's been some recent launches and the toxin.

Talks and space that have gone a little bit less than stellar. So wondering if you could talk about lessons learned and how you might stage. This launch.

In terms of getting experience and then broadening if there if there is any kind of expectations you can set for us once we knock on wood getting approval. Thank you.

Great. Thanks, Ken Great questions. So the first one in terms of where we're at in the agency with other aspects of our BLE review.

We're kind of breaking typical tradition here in commenting on the site inspection as it relates to where we are in the BLE process and the reason that we are doing this that.

Every quarter, we give it an update and oftentimes will kind of reconfirm some of our different milestones and where were at you know since the FDA resumed site inspections earlier in the year. Following the first cobot wave we've been optimistic that our.

Visit would happen in sort of the due course, however, our confidence in the ability to conduct a site visit in time for produced to date of November 10, 25th has reached a point, where now 60 days out from our PDUFA approval. We thought it was appropriate to share. The fact of a lack of inspection.

Theres still time that it could happen before the PDUFA timeframe, but we thought it was appropriate given the cobot in my apartment dish to share that as it relates to sort of other parts of the review process, we consistent with our prior policy, we don't think it's appropriate.

Mark J. Foley: Now let me address the potential for a delay in our approval associated with our outstanding BLA submission for daxibotulinum toxin A for injection in glabellar lines, which we shared in our third quarter financial release. As reported by several biotech companies, the FDA has been delaying some site inspections and corresponding drug approvals due to COVID-related travel restrictions. With just 16 days to go until our previously announced PDUFA date of November 25, we felt it was appropriate to provide an update on our status. As of today, the FDA has yet to schedule a site inspection of our U.S.-based manufacturing facility in Newark, California. The agency has previously noted that a site inspection is required prior to approval of our VLA. However, the FDA has also communicated that their ability to conduct inspections is limited based on their COVID-19-related guidance and travel restrictions currently in place.

To comment on where we are in that process. Since the discussions are ongoing however, what I would say is we feel very confident in the quality of the submission that we put forward.

And we continue to work collaboratively with the agency.

On your second question about sort of lessons learned from other launches.

Mark J. Foley: While there's still a chance that an inspection could be conducted prior to November 25, we wanted to acknowledge the possibility that our drug might not be approved on our PDUFA date. At this time, we do not have any additional information and do not plan to elaborate further. We continue to work proactively with the agency to secure an inspection at the earliest possible time.

Yes, I think each each sort of launch is going to be unique and different we've got the benefit of sort of looking at each of those and trying to learn certainly from those that have gone before us.

However, what I would say is our strategy is very different I think because of the.

Products that we've assembled and the differentiation we are taking a different approach, we're creating a new category in the prestige segment.

We're very targeted and focused in terms of the customers that we're going after in addition to the quality of the products, we've got a little bit of a different strategy around sort of pricing and positioning in the market and what I would point to is sort of the early traction that we're seeing with the RMG a lot of fillers I think that the strategy that we laid out seems to make a lot of sense.

It's resonating.

And I think as Weve communicated before we plan to take a similar approach once daxibotulinumtoxina for injection gets approved where we're going to be very measured in our approach we're going to start with a small group to get good user experience will then go through the preview program. There and then sort of fully launch as we get into sort of the Q3 time frame. So I just think you are very.

Mark J. Foley: With the strategic transactions we made earlier this year with the RHA collection and NMD platform, Revance is more diversified than ever before and less dependent on any single revenue stream. Revance's cash guidance remains unchanged as we continue to project that the company is funded into 2023 due to the puts and takes associated with the new product launch. Should we have a delay in our FDA approval, we believe the company is in an excellent position, both commercially and financially, to weather any change to the timing of a potential approval. We also remain confident in the overall strength of our BLA submission and will continue to work proactively with the agency to complete the necessary site inspection.

Different strategies and certainly we've tried to learn from what the market is said, we feel really good about our position in sort of the creation of this new prestige category.

Thanks, so much.

Thanks, Ken.

Your next question comes from the line of Annabel Samimy with Stifel.

Hi, Thanks for taking my questions. So I had a few here.

First on.

Mark J. Foley: Now, let me turn to our therapeutics franchise. We were thrilled to announce in October the positive results from our Aspen I Phase III Pivotal Trial of doxybotulinum toxin A for injection in the treatment of cervical dystonia, which we believe will underpin the next stage of growth for Revance beyond aesthetics. The Aspen 1 trial met its primary endpoint and secondary endpoint across both doses with high statistical significance, and the study revealed a potentially differentiated safety profile with a long duration of effect of 24 weeks. Importantly, we were able to deliver these results with a low dose of active neurotoxin with low adverse event rates, particularly as it relates to dysphagia and muscle weakness. We believe that being able to potentially reduce the number of treatments, along with corresponding practice visits, by up to 50% a year is meaningful to patients, caregivers, physicians, and payers alike. Based on these results, Daxibotulinum toxin A for injection could represent a material advancement in cervical dystonia care and result in significant pharmacoeconomic savings.

The initial reception training requirements and around our each added notice you started or refinance huge so.

Can you talk a little bit about how much they need to be trained to use this new filler.

And also are you starting to incorporate some thoughts about how you're going to train physicians around Dusty I know, it's not approved yet, but presumably some of the physicians has worked with us before.

On the Therapeutics front now that center fasciitis, as I guess sort of out of the picture any further start thoughts and starting up in.

Migraine or any other therapeutic indication and then finally on its Andy.

I guess can you.

Now that it's sort of up and running.

Can you see any trends and is there anything that you can see right now that you can leverage beyond what you expected to be able to do it since Andy is the reception better.

Better or.

Or neutral or worse than what you would have expected. Thanks.

Thanks, Annabel I'll go ahead, and let the dust and hit the first question I will take the next two.

Mark J. Foley: The Aspen OLS, or Open Label Safety Study for cervical dystonia, continues, with results expected in 2021. Accordingly, we are aiming for regulatory approval for our first therapeutic indication in 2023. Let me remind you that Cervical Dystonia is a $340 million market, sizable in and of itself, but only a portion of the $2.3 billion global therapeutic market for botulinum toxin. In addition to cervical dystonia, we are pursuing another muscle movement disorder, upper limb spasticity, and plan to report results from the Juniper Phase 2 trial in the first quarter of 2021. Which brings me to today's plantar fasciitis results. In conjunction with our third-quarter earnings release this afternoon, we announced results from our Phase 2 trial of Daxibotulinum toxin A for injection for the management of plantar fasciitis, a painful affliction of the foot.

Yes, thanks and on the on the RLJ training requirements right now training for our Ha collection is not required meaning it's not mandatory however, what we've seen is unique formulation. How this range of products was created allows for a different injection technique a bit more superficial than what's currently available with high safety.

Metrics behind that and so what we've done is we've taking a bunch of the global experts and we kind of co left them under romance use that allows for us physician to get tripped tips and tricks and also just to better understand the technology from the global ambassadors that have been injecting it for years and then we have now trained also us at Google.

Does that allow us to then kind of tease out the nuances with the formulation of our ha. It really allows you to do things differently and so were encouraging training, we've seen a high level of.

Mark J. Foley: In the trial, both the 80-unit and 120-unit doses resulted in measurable pain relief that was numerically greater than placebo on the numeric pain rating scale. However, neither dose met the primary efficacy endpoint of statistically significant improvement in the NPRS for foot pain at week 8 when compared to placebo. Vaccine botulinum toxin A for injection appeared generally safe and well-tolerated when injected into the foot

Engagement in our platform both virtually.

And also on demand. So so I hope that answers your question on training and then I'll turn it over back to Mark on the taxi training side, yes. So to hit the second part of that question I think on the active side, what we've talked about in the past and still holds water. Today is once we get approval for Daxibotulinumtoxina for injection. It will be the first time that we will have used it outside.

Clinical trials and so therefore, weve always sort of indicated that we need to be very thoughtful and measured and therefore, our rollout and launch strategy was going to be start with a small group of physicians to get commercial experience outside of the trials Q1 in Q2 roll into our preview accounts roughly 100 positions or so.

Tobin C. Schilke: No other neuromodulator has been approved for the treatment of plantar fasciitis, so we were attempting to stake out a first-mover advantage in a new therapeutic category with underlying physiology that is different from existing muscle movement or pain disorders. While we plan to further analyze the data, our primary focus will be on indications where the market and path through approval are well established for neuromodulators. Now with the strong phase 3 cervical dystonia data, we can advance our initial commercial planning and therapeutics, and we're looking forward to reporting the Juniper phase 2 clinical results for upper limb spasticity in the first quarter of 2021. Combined, these results will help us formulate our clinical strategy and therapeutics going forward. With that, I'll now turn the call over to Toby Schilke to cover the financial... Thank you, Mark. Starting with our cash, cash equivalents, and short-term investments balance, we ended the third quarter with $436 million, which we believe is sufficient to fund our planned operations into 2023.

So that will use it down a little bit more broadly, but still in a pretty controlled way and then use those learnings around feedback from those positions messaging and everything to inform the kind of the broader scale launch in Q3 similar to what we just recently did with our Ha collection in September so pretty similar strategy, except an extra quarter that begins.

From there to get some real world experience again from talking to the physicians. They are less concerned about injecting it and watching to see duration as they are injecting it to make sure that the Q response is what they're looking for and they can turn those around pretty quickly. So we think that.

Through the Rhj launch we've garnered a lot of insight into the right way to do this and we continue to feel that that will be the right launch strategy for.

Further modulator once it gets approved your second question on sort of now with the Pf read out how does that inform our therapeutic strategy going forward. So we've always talked about this is a really exciting and pivotal time for the company as we read out the cervical dystonia phase three the plantar fasciitis phase two and the upper limb spasticity phase two.

Tobin C. Schilke: Revenue for the third quarter of 2020 consisted of $3.8 million, which primarily represents initial orders for the RHA collection of dermal fillers. You will note that our revenues are now broken out into three categories on the income statement. During the quarter, product revenues from the RHA collection were $2.8 million, collaboration revenues from our MyLand partnership were $0.8 million, and services revenue from the HintMD platform were $0.2 million. For the third quarter, our operating expenses were $81 million.

We were disappointed that we didnt see more separation between the treatment arm and placebo, but.

But it has helped us sort of focus our attention and efforts going forward clearly in muscle movement disorders, the promise of a longer duration neuromodulator carry real value. So we're going to lean into CD.

You will ask fits into that same category of muscle movement disorder, and and is administered by neurologists. So we have any greater visibility to a strategy thats going to center around the neurologist and we'll want to see that phase two data.

That's the direction that we're going as it relates to migraine and other existing approved indications I think that we'll finalize that as we kind of get these data package out and.

Tobin C. Schilke: Excluding the cost of revenue depreciation and amortization, stock-based compensation, and RHA-related in-process R&D, our operating expense was $65.4 million. The earnings release we issued today outlines our financial results in full, so I'll not go through the details on this call. In terms of our 2020 outlook, GAAP operating expense, including the effects of the HintMD acquisition, is expected to be $285 to $295 million. Non-GAAP operating expense remains in the range of $220 to $230 million.

Make our plans for 2021, but as we've always talked about migraine, it's not as if it's a win and so we'll be thoughtful about kind of how we invest in the different therapeutics going forward, but we continue to like the optionality that exists as we move forward and continue to leverage this unique neuro neuromodulator.

The last one on his MD in terms of are there any additional.

Insights or trends I will say that in this cobot environment. The one thing that has been nices.

Offices, they are going to a little bit more remote payments in contact list process payment and.

And so I think that the promise of the platform offering that at allowing for secure transactions to take place has been attractive.

Tobin C. Schilke: This excludes the cost of revenue, depreciation, amortization, stock-based compensation, and RHA-related in-process R&D. We continue to expect our 2020 non-GAF, non-HNT-MD research and development expense to be $95 to $100 million. In terms of future revenue, our policy remains to refrain from providing sales guidance until we can determine the launch trajectory of the RHA collection and HINT-MD platform. Finally, Revance's shares outstanding as of October 30, 2020, were approximately 66.5 million shares with 72.4 million shares on a fully diluted basis, excluding the impact of convertible debt.

Certainly as reported out today, we do have some visibility to overall volume trends. So it does give us.

Way to validate what we're seeing in the market with what's happening on the payment side of it and I'm sure as we move forward. We will continue to uncover additional insights that we can either share with our physician partners to help them run their business in a better way or insights that help us be a better partner on the corporate side.

In terms of sort of how we're thinking about it.

We're very excited I think that we continue to have conviction that this is a really important part of our overall aesthetics franchise.

That by combining sort of really leading services around loyalty and subscriptions and other things down the road are going to be an important point of differentiation of the product side of it. So we continue to really like where we're positioned we thought that the integration has gone very well the teams are working collaboratively and.

Tobin C. Schilke: And with that, I'll turn the call back over to Mark. Thank you, Toby. Revance is building a powerful aesthetics franchise and has now demonstrated, through our positive Aspen One cervical dystonia results, the company's potential to create a similarly strong franchise in therapeutics. Importantly, we are entering established markets worth a combined $6 billion worldwide, armed with the next generation of products and services. With that, I will now open the call up for questions. Operator? At this time, in order to ask a question, press the star, then the number one on your telephone keypad.

And so we're really looking forward to continuing to drive both of those products into the marketplace.

Great. Thanks, a lot thanks Adam.

[music].

Your next question comes from the line of Terence Flynn with Goldman Sachs.

Hi, Thanks for taking the questions.

I was just wondering on the taxi manufacturing inspection. If you can provide any sense as to what criteria that is using to think about the travel restriction like does it depend on the positivity rate in the city, where the facility is located or is it more dependent on having personnel available and then.

My next question is just on the revenue guidance I know you are not providing that currently but is that something that you think we should expect as we think about 2021. Thank you.

Operator: Your first question comes from the line of Ken Cacciatore with Cowan & Company. Mark, I don't know if you could just characterize for us where you stand outside of the manufacturing inspection. Do you feel you're far along with the rest of the review? Are you kind of engaged in a label at this point? So any color you could provide there would be great.

Great question Terence So first one in terms of feedback from the agency I think with the continued to point is two or the guidance that they put out back in July when they started resuming inspections and it is everything you mentioned if you look at the guidance. It has to do with sort of a hierarchy of priorities and it also has to do with whatever sort of the travel related.

Ken Cacciatore: And then, second question, as we think about eventual approval and launch, there have been some recent launches in the toxin space that have gone a little bit less than stellar. So I wonder if you could talk about lessons learned and how you might stage this launch in terms of getting experience and then broadening if there's any kind of expectations you can set for us once we, knock on wood, get approval. Thank you. Great. Thanks, Ken.

Strengthens our given.

The different geographies. So I think it's going to continue to be a dynamic situation we.

We don't have any additional insight other than that we are a us based manufacturer we are in northern California single manufacturing sites. So.

We're ready whenever whenever they're ready and I think that this will continue to be sort of a dynamic thing, but they I think continue to just point to the guidance that they put out as it relates to that.

On the revenue guidance.

We're just we're early and so we don't want to do is to give you metrics or numbers to anchor on before we really have good visibility.

Mark J. Foley: Great question. So, you know, the first one in terms of where we're at in the agency with other aspects of our BLA review. We're kind of breaking typical tradition here and commenting on the site inspection as it relates to, you know, where we are in the BLA process. And the reason that we're doing this is that, you know, every quarter we give an update, and oftentimes, we'll kind of reconfirm, you know, some of our different milestones and where we're at. You know, since the FDA resumed site inspections earlier in the year following the first COVID-19 wave, we've been optimistic that, you know, our visit would happen in sort of the due course. However, our confidence in the FDA's ability to conduct a site visit in time for a PDUFA date of November 10, 25th has reached a point where, now 16 days out from our PDUFA approval, we thought it was appropriate to share, you know, the fact of a lack of inspection.

So we sort of one month into our launch we havent been able to sort of observe reorder patterns or those types of things and certainly we've got a range of skews that are out there.

Certainly our goal is to be as transparent as possible as we have more visibility into the things.

We will of course also be mindful of the competitive dynamics in the market. There are there's not a lot of data out there on.

Mark J. Foley: There's still time that it could happen before the PDUFA timeframe, but we thought it was appropriate, you know, given the COVID environment, to share that. As it relates to sort of other parts of the review process, we, you know, consistent with our prior policy, we don't think it's appropriate to comment on where we are in that process since the discussions are ongoing.

Filler peers out there so we what we want to make sure that we're giving you. Good information in terms of how you think about the business and how we think about the business. We also want to be mindful to what we put out there competitively, but I think we probably need another quarter or two as it relates to the Rhj collection of fillers and the NMD platform to give more meaningful metrics if we.

Get those sooner a little later, we'll give them too we have confidence in them. So it's still premature to give revenue guidance at this stage.

Thanks.

Your next question comes from the line of David Amsellem with Piper Sandler.

Mark J. Foley: However, what I would say is we feel very confident in the quality of the submission that we put forward, and we continue to work collaboratively with the agency. On your second question about lessons learned from other launches, you know, I think each sort of launch is going to be unique and different. We've got the benefit of sort of looking at each of those and trying to learn, certainly from those that have gone before us. However, what I would say is, you know, our strategy is very different.

Hey, Thanks, So just a couple so and I apologize if I missed this earlier, but can you talk about the extent to which you are giving away free.

Our ha fillers and.

Talk about.

How.

Significant that is a piece of the.

Overall demand.

Mark J. Foley: I think because of the products that we've assembled and the differentiation, we're taking a different approach. You know, we're creating a new category in the prestige segment. We're very targeted and focused in terms of the customers that we're going after. In addition to the quality of the products, we've got a little bit of a different strategy around, you know, sort of pricing and positioning in the market. And what I would point to is sort of the early traction that we're seeing with the RHA line of fillers. I think that, you know, the strategy that we've laid out seems to make a lot of sense. It's responding.

Least initially.

And then tangentially related question is on taxi, what's the extent to which you are going to be providing free free product there.

How big of a piece.

How big of a piece.

Of the initial launch will be free product as a as a means of demand stimulation. So that's number one and then number two is can you just remind us where things are in terms of line extensions.

For Ari Chad I think there was already say one and just in general.

What.

Is down the Pike in terms of adding to the franchise given that all the other Philip franchise, certainly a multi product and there is often a lot of refreshing of the franchises.

Mark J. Foley: And I think, as we've communicated before, we plan to take a similar approach once Daxubotulinum and Toxin A for injection gets approved, where we're going to be very measured in our approach. We're going to start with a small group to get a good user experience. We'll then go through the preview program there and then, you know, sort of fully launch as we get into sort of the Q3 timeframe. So I just think they're very different strategies and certainly we've tried to learn from what the market has said, but we feel really good about our position in sort of the creation of this new prestige category. Thanks so much.

Extension, so you talked about that that would be helpful. Thanks.

Okay.

Hey, David This is Dustin thanks for the question as it relates to the free goods, you mentioned demand generation and we really look at the market in a way in which price based off price doesn't have to be what we used to generate demand with innovation. Both an already changed ACSI, we can use the products and their kind of their outcomes and what they deliver to the patients as what drives the demand.

Mark J. Foley: Thanks Ken. Your next question comes from the line of Annabel Samy with Stiefel. Hi all, thanks for taking my questions. I had a few here.

As well as the exclusivity. So I think we've taken to a unique approach to the market from that way. We don't currently provide free product for our ha and.

Annabel Eva Samimy: First, on the initial reception and training requirements around RHA, I did notice you started using Revance. So can you talk a little bit about how much they need to be trained to use this new filler? And also, are you starting to think about how you're going to be training physicians around DAXI? I know it's not approved yet, but you know, presumably some of the physicians have worked with it before. On the therapeutics front, now that plantar fasciitis is, I guess, sort of out of the picture, any further thought to starting up in migraine or any other therapeutic indication?

Or to actually obviously.

For for use of trying to drive that demand, we do use demonstration product to drive awareness of the clinical benefits of the product both from the filler perspective, and so they use that to to to see themselves injecting staff members most of the time and others to get experience for the unique properties of that product and then ultimately their car.

Pedant in their clinical outcomes is what drives demand as well as our ability to to have it available and exclusive or select offices. Another unique pieces is no we don't even allow pricing to.

To be.

Advertise to consumers. So we have a basically a global brand policy that insures that price is not the driver for the demand from the consumer's perspective, either we want the consumer going to the practices that deliver the best outcomes. So that that approach will kind of transfer across all our advanced the statics not using free product as the driver on your.

Dustin S. Sjuts: And then finally, on HINT-MD, I guess, can you, now that it's... Transcripts provided by Transcription Outsourcing, LLC. Thanks, Annabel.

Second question or your third question RJ I didn't quite get the.

The pipeline so far I would say one of the clinical trial already Jay one is complete no that our partner Geox, saying manages kind of the clinical development pipeline in partnership with US I mean is complete and it will be filing that by the end of the year for approval. We're also looking at obviously other indications, we'll talk about those as those get into clinic.

Dustin S. Sjuts: I'll go ahead and let Dustin take the first question, and I'll take the next two. Yeah, thanks Annabel. On the RHA training requirements, right now, training for RHA collection is not required, meaning it's not mandatory.

And are more public information.

Thanks.

Dustin S. Sjuts: However, what we've seen is the unique formulation and how this range of products was created allows for a different injection technique, a bit more superficial than what's currently available with high safety metrics behind that. And so what we've done is we've taken a bunch of the global experts and we've kind of coalesced them under Revance Youth. So it allows for U.S. physicians to get tips and tricks and also just to better understand the technology from the global ambassadors that have been using it for years. And then we've now trained U.S. gurus that allow us to then kind of tease out the nuances.

Your next question comes from the line of Chris Patel with Guggenheim.

Hi, great. Thanks for the questions Sean.

Sean for pushing this year.

Maybe a couple of questions maybe we'll go through that and then a couple of other questions I had.

We had recently stuck with us in this setting positions and it seems really because hurdle to central willingness to try it might be on the economic side of things.

Just curious how how the sales team potentially address that concern with no hats.

Dustin S. Sjuts: With the formulation of the RHA, it really allows you to do things differently, and so we're encouraging training. We've seen a high level of engagement on our platform, both virtually and also on demand. So I hope that answers your question on training. And then I'll turn it over back to Mark on the DAXI training side.

Reduce deployment frequency per patient.

Longer duration.

Okay, and then essentially with CD out in 2023, just curious if you could provide some color us.

Why.

A year and a half years.

Mark J. Foley: Yeah, so to hit the second part of that question, I think on the DAXI side, what we've talked about in the past and still holds water today is, once we get approval for DAXI botulinum toxin A for injection, it will be the first time that we will have used it outside of clinical trials. And so therefore, we've always sort of indicated that we need to be very thoughtful and measured. And therefore, our rollout and launch strategy was going to start with a small group of physicians to get commercial experience outside of the trials Q1.

I assume the safety, but just some.

Additional color on what that is looking for there.

And then maybe on on cleaner.

No I know going to draw there were a couple of changes.

For example, the dosing.

As well as the endpoints for example, the dosing was I think half of what was used in cervical dystonia.

I was just trying to understand if the potential as Leds.

Mark J. Foley: And Q2, roll out to our preview accounts, you know, roughly 100 physicians or so that will use it then a little bit more broadly but still in a pretty controlled way. And then use those learnings around, you know, feedback from those physicians, messaging, and everything to inform kind of the broader-scale launch in Q3, similar to what we just recently did with the RHA collection in September. So pretty similar strategy except, you know, an extra quarter at the beginning there to get some real world experience. Again, from talking to the physicians, they're less concerned about injecting it and watching to see the duration as they are injecting it to make sure that that acute response is what they're looking for. And they can turn those around pretty quickly.

Failure, there and then obviously understanding there's been quite a few.

If there was any potential learnings from additional analyses.

I was hoping to do.

And then just lastly on the art say or launches.

Launches just trying to understand more of those launches maybe any additional metrics no for example.

And the kind of high teens that see where potentially with the team.

An incremental step up.

His improve later thanks.

Great question, So, we'll try and try and capture all them here. So first one on taxi and sort of feedback that you've heard from the field in terms of willingness to try the product we've not given out specific pricing information at this time, but we have talked about is based on our market research and because of the hundreds and millions of dollars that we've invested that we would expect.

Mark J. Foley: So we think that, you know, through the RHA launch, we've garnered a lot of insight into the right way to do this, and we continue to feel that that will be the right launch strategy for a neuromodulator once it gets approved. Your second question on, you know, sort of now with the PF readout, how does that inform our therapeutic strategy going forward? So we've always talked about this being a really exciting and pivotal time for the company as we read out cervical dystonia phase three, plantar fasciitis phase two, and upper limb spasticity phase two. Clearly, we're disappointed that we didn't see more separation between the treatment arm and placebo, but it has helped us sort of focus our attention and efforts going forward. Clearly, in muscle movement disorders, the promise of a longer duration neuromodulator has real value.

This to be a premium priced neuromodulator because of the duration profile and that in the discussions that we've had with physicians, we believe that they will be able to charge more as well.

And that consumers will pay more than we should get more as a reward for the innovation.

If you look at a lot of the market data out there average consumers for Neuromodulators only come in about twice a year as it is which means that based on the duration profile of existing neuromodulators. They end up in a zone of under treatment for a period of time. So we actually think that with a product with this duration profile physicians will be able to charge more fuzzy.

Mark J. Foley: So we're going to lean into CD. You know, ULS fits in that same category of muscle movement disorder and is administered by neurologists. So, you know, we have greater visibility into a strategy that's going to center around the neurologist. And, you know, we'll want to see that phase two data. But that's the direction that we're going. As it relates to migraine and other, you know, existing approved indications, I think that, you know, we'll finalize that as we kind of get this data package out and, you know, make our plans for 2021. But as we've always talked about, migraines, it's not an if; it's a when.

Patients will come in probably at a frequency level that is consistent with what they do today and so everybody wins the patient pays a little more of it gets longer duration of the fact that they are paying to come in for additions make more per visit and we do well and manufacture for driving innovation again, we're looking to segment the market I don't expect.

But in an account, though which everything out but we believe that there is a healthy part of the market that will opt into sort of this prestige or premium product offering and we think they co exist. If you look at a lot of accounts today, they will end up with more than one neuromodulator on the shelf they'll have one or two different fillers on the shelf and so they will offer the products that they think reza.

Mark J. Foley: And so we'll be thoughtful about, you know, kind of how we invest in the different therapeutics going forward. But we continue to like the optionality that exists as we move forward and continue to leverage this unique neuromodulator. The last one on HIN-MD in terms of are there any additional, you know, sort of insights or trends? I will say that in this COVID environment, the one thing that has been nice is that in offices, they are going to a little bit more remote payments using contactless process payments. And so I think that the promise of the platform offering that and allowing for secure transactions to take place has been attractive.

I think the most with consumers and so we think this sort of premium or kristi strategy resonates really well and aligns with our market data and we'll obviously give out the pricing information as we get into the launch cycle, but we do think that there is a premium for everybody.

In terms of the CD side of things and what's gating the timing there.

We talked about completion of our enrollment in the open label study in August of this past year, we now need to complete all the follow ups. We then have the end to phase three meeting with the FDA, we've talked about a submission in 2022 and then an approval in 2023. So that's just basically driven by completing the trial wrapping up the data meeting with the.

Mark J. Foley: Certainly, as reported out today, we do have some visibility into overall volume trends, so it does give us a way to validate what we're seeing in the market with what's happening on the payment side of it. And I'm sure as we move forward, we'll continue to uncover additional insights that we can either share with our partners to help them run their business in a better way, or insights that help us be a better partner on the corporate side. In terms of sort of how we're thinking about it, we're very excited. I think that we continue to have conviction that this is a really important part of our overall aesthetics franchise and that combining sort of really leading services around loyalty and subscriptions and other things down the road is going to be an important point of differentiation above the product side of it. So we continue to really like where we're positioned. We think that the integration has gone very well. The teams are working collaboratively.

Agency, and so thats kind of how we get to that timeline.

On the Pf and sort of some of the changes that we make as you referenced this is our second phase two study.

In the first study that we ran we again saw really good pain reduction with both treatment groups.

But we saw a surprisingly high placebo response rate. So the changes that we made were designed to try and better separate out placebo from treatment again in this phase two study we showed really good pain reduction in both treatment arms, but also again, an unusually high placebo response rate and so we had done a variety of.

Mark J. Foley: And so we're really looking forward to continuing to drive both of those products into the marketplace. Great. Thanks a lot.

Things before we injected both the cap in the heel. So we went to just to heal because the cap can be a trigger point release for dry needling and we thought maybe we can do that we.

Annabel Eva Samimy: Thanks, Annabel. Your next question comes from Terence Flynn with Goldman Sachs. Hi, thanks for taking the questions. I was just wondering about the DAXE manufacturing inspection, if you can provide any sense as to what criteria that FDA is using to think about the travel restriction, like does it depend on the positivity rate in the city where the facility is located, or is it more dependent on having personnel available?

Terence C. Flynn: And then my next question is just on revenue guidance. I know you're not providing it currently, but is that something that you think we should expect as we think about 2021? Thank you.

We changed the way that the inclusion criteria to make sure that we are capturing those with true plantar fasciitis pain.

Rather than just measuring one single point in time for the pain measurement, we did over the course of five days. So that we tried to make sure that we captured it. Unfortunately, despite the changes that we made with really good input from a lot of clinicians out there and insight. We again ended up with a really high placebo response rate. So we're we're disappointed that the.

Product report performed well showed a really good so.

Safety profile as well, but I think that as we've gone back and we've sort of reflected on things plantar fasciitis is a very different physiology.

Mark J. Foley: Great questions, Terence. So, first one in terms of, you know, feedback from the agency, I think what they continue to point us to is the guidance that they put out back in July when they started resuming inspections. And it is everything you mentioned, if you look at the guidance, it has to do with sort of a hierarchy of priorities. And it also has to do with whatever sort of travel-related restrictions are given, you know, the different geographies.

Inflation of planar fascia is secondary to injury Theres a lot of other things going on and if we look at our other programs in muscle movement, and you know existing indications for pain. Those are categories, which are much better characterized in the performance of neuromodulators in those categories makes sense.

And you know for US right now that the thing that we've demonstrated in two phase III trials is an encouraging duration profile. So I think focusing on those indications that are known where our product profile has an opportunity to be very competitive is a more judicious investment of our resources and time.

Mark J. Foley: So I think it's going to continue to be a dynamic situation. We don't have any additional insight other than that. You know, we are a U.S.-based manufacturer. We are in Northern California.

Well to your point do some additional subset analysis see theres other things that we can glean from it but I think with where we are today, we're going to focus more on kind of the muscle movement and existing indications as sort of our primary focus.

And then last one you had was on the R.J. antibody in combination of the two me. It's early right now we took two disparate organization we're.

Organizations put them together, we think we've done a great job of distilling down the message, making sure that we can get leverage where possible.

We're early in that we think that the products that we're introducing into the market fit very well with the discussion around services that can help the practices and vice versa. So while it's early we do believe that there will be some pretty good synergies that we can unlock as we move forward and we link the two together, but it's still early and I think more to come.

Mark J. Foley: It's a single manufacturing site. So, you know, we're ready whenever they're ready. And I think that this will continue to be sort of a dynamic thing. But they've, I think, continued to just point to the guidance that they've put out as it relates to that. You know, filler peers out there.

As we move forward.

Your next question comes from the line of Tim Lugo with William Blair.

Hi, Thanks for taking the questions and I just wanted to confirm is you know a few inspectors would be to come out.

And and they are not regional inspectors I know theres been a movement away from local inspectors more towards.

Mark J. Foley: So we want to make sure that we're giving you good information in terms of how you think about the business and how we think about the business. We also want to be mindful of what we put out there competitively. But I think we probably need another quarter or two as it relates to the RHA collection of fillers and the NMD platform to give more meaningful metrics. If we get those sooner, a little later, you know, we'll give them to them when we have confidence in them. So it's just a little premature to give revenue guidance at this stage. [inaudible] Your next question comes from the line of David Amsellem with Piper Sandler. Hey, thanks. So just a couple.

National chains, depending on the indication.

David A. Amsellem: So I apologize if I missed this earlier, but can you talk about the extent to which you're giving away free RHA fillers and talk about how significant that is as a piece of the overall demand, at least initially. And then a tangentially related question is, on Daxi, what's the extent to which you're going to be providing free product there? And how big of a piece of the initial launch will be free product as a means of demand stimulation? So that's number one. And then number two is, can you just remind us where things are in terms of line extensions for RHA? I think there was RHA1.

And I guess product or if you're just.

Due to the travel restrictions are what is the.

What is the hurdle and maybe you mentioned this already but can you just confirm receipt, especially as the last major issue outstanding the review.

Yes, so Tim Great question. So in terms of the what we've heard from the agency what they have confirmed that they will need to perform a site inspection I think that has to do with the fact that we have not qualified this manufacturing site for any other product. So this will be our first approval, which is why in inspection does need to take place.

They pointed us to is kind of their prior guidance of saying that you know here is sort of the guidance we've got.

Protocol, so we got to follow and that travel rate related restrictions will impact that.

That's basically what we know today, we are continuing to.

Worked proactively our PDUFA date has not come yet we're still hopeful that perhaps the inspection will take place prior to them, but as we mentioned earlier with now being 60 days away from the PDUFA and no site visit scheduled knowing that we need to have and we thought it was appropriate to share with it again, we do feel good that we're a us single site manufacturing.

David A. Amsellem: And just in general, what is down the pike in terms of adding to the franchise, given that all the other filler franchises are certainly multi-product, and there's often a lot of refreshing of the franchises with new extensions. So if you could talk about that, that would be helpful. Okay, hey David, this is Dustin. As it relates to the free goods, you mentioned demand generation.

I'd here in Northern California.

Dustin S. Sjuts: And we really look at the market in a way in which price doesn't have to be what we use to generate demand. With innovation, both on RHA and DAXI, we can use the products and their outcomes and what they deliver to the patients as what drives demand, as well as that exclusivity. So I think we've taken a unique approach to the market in that way. We don't currently provide free product for RHA and DAXI, obviously, for the use of, you know, trying to drive that demand.

So we we are anxiously awaiting that we've not commented on any other details around the actual BLA submission, we think its appropriate other than to say that we continue to feel very good about the quality of the submission that we put in and.

And we continue to work collaboratively with the agency and was there a second part of the question.

Okay.

I guess you maybe you touched on it so we kind of lost outstanding issue further view, but it sounds like you're very comfortable to quality.

Dustin S. Sjuts: We do use demonstration products to drive awareness of the clinical benefits of the product, both from the filler perspective. And so they use that to see themselves, injecting staff members, most of the time, and others to get experience with the unique properties of that product. And then ultimately, their confidence in their clinical outcomes is what drives demand, as well as our ability to have it available in exclusive or select offices. Another unique piece is that we don't even allow pricing to be advertised to the consumer.

If you were if the inspection were to occur tomorrow, and there were some floor 40 threes.

Would you even be able to turn them around given the schedule.

So we just kind of assume a delay as of now.

I don't I mean, great questions I think were theorizing I think we're just trying to share what information, we definitely know I think that as we start getting into the you know.

Potential of this or that it's hard to say, we're not to the clock I know this is so were atypical to report this out prior to the due to date, but we just we thought it was the appropriate thing to do given the company update so it's hard to theorize sort of whether or not we could if theres anything that were to come up but we're ready we're ready for them whenever they show up so.

Dustin S. Sjuts: So we have a basically a global brand policy that ensures that price is not the driver for demand from the consumer's perspective, either. We want the consumer going to the practices to deliver the best outcomes. So that approach will kind of transfer across all our advanced aesthetics, not using free product as the driver. On your second question, or your third question on RHA, I didn't quite understand the pipeline. So for RHA-1, the clinical trial for RHA-1 is complete. Know that our partner Teoxane manages the clinical development pipeline in partnership with us. It is complete, and they will be filing it by the end of the year for approval.

Okay understood maybe one last commercial question you did 2.8 million Rhj revenue. This quarter. It was only a partial quarter what was kind of the underlying demand and should we switch.

So we assume that it's.

The demand might be 6 million and build off of there or can you just talk about if there were any kind of onetime loading or inventory.

Dustin S. Sjuts: We're also looking at, obviously, other indications. We'll talk about those as those get into clinic and are more public information. Thanks.

Okay in that number.

Yes. So great question I think that's why we're just on a position to give guidance yet because it is so early I mean, the rhj sales really reflect our sales in September but.

Kush Patel: Your next question comes from the line of Kush Patel with Guggenheim. All right, great. Thanks for the questions, Sushant, for Seamus here.

As you can imagine these are initial purchases, where if you look at the buying patterns for fillers. They.

Every council little bit different but given the fact that it's a new product they tend to order a reasonable amount of products. So they can get really good experience with it so.

Kush Patel: Maybe a couple of questions, maybe we'll go through Daxian, and then a couple other questions I had. You know, we recently spoke with some aesthetic physicians, and it seems really the biggest hurdle to potential patients' willingness to try it might be on the economic side of things. So just curious how the sales team could potentially address that concern with, you know, perhaps, reduced appointment frequency per patient given the longer duration. And then, you know, potentially with CD, you know, out in 2023. Just curious if you could provide some color as to why it's out a year and a half, two years, given, I assume, the safety, but just some additional color on what the FDA is looking for there.

So I don't I don't think you should take sort of the September month, and multiply it by three for Q4. Because these are early accounts that our reps know that we're going to again, we're very focused on going deep not white to make sure that people that partner with us are very committed to sort of this premium category that we're looking to create.

So I just think it's early right now again, it's obviously, a very strong start giving one month of launch and the feedback we're getting is very positive, but it's just it's a little bit too early to know what that reorder cycle is going to look like what the stickiness of the product is going to be and certainly we'll be able to give you more insight into that as we as we report our Q4.

Kush Patel: And then maybe on planar fasciitis with, you know, I know going into the trial, there were a couple of changes, you know, for example, the dosing, as well as the endpoints. For example, the dosing was half of what was used in cervical dystonia, you know, just trying to understand if the potential for that led to, you know, the failure there.

Numbers lenders.

Understood. Thank you for the clarity thanks, Tim.

Your next question comes from the line of Certegy Ballenger with Needham and company.

Hi, Good afternoon, just a couple questions for me the first one for Mark Dustin can you just talk about current patient flow levels.

Mark J. Foley: And then obviously understanding there's been quite a few, if there's any potential learnings from additional analyses that the team is hoping to do. And then, just lastly, on the RHA or HIN-MD launches, just trying to understand more of those launches, maybe any additional metrics, you know, for example, is HIN-MD kind of tied to DACI where potentially we could see an incremental step up when DACI is, you know Thanks. A great question. So, we'll try and capture all of them here.

Have they recovered from where have they recovered from pre tilted levels and.

Are they still recovering through.

I guess mid fourth quarter.

And then secondly on the AR issues filler pricing.

Can you tell us where you have price the products relative to the competition.

And.

What you are seeing physicians price the product.

Further consumes.

Thanks, Thanks, or just Dustin I think on the patient flow I think we talked a little bit about it on the internet side as well we've been really pleasantly surprised the patient flow is coming back a course, some practices are different but but in most states. We're seeing that the aesthetic practices are doing well, even right at or above pre cobot level.

Mark J. Foley: So, first one on DAXI and the sort of feedback that you've heard from the field in terms of willingness to try the product. You know, we've not given out specific pricing information at this time, but what we have talked about is based on our market research and because of the hundreds of millions of dollars that we've invested, we would expect this to be a premium priced neuromodulator because of the duration profile. And the discussions that we've had with physicians, we believe that they will be able to charge more as well and that, you know, consumers will pay more, and that we should get more as a reward for the innovation. If you look at a lot of the market data out there, average consumers for neuromodulators only come in about twice a year as it is, which means that based on the duration profile of existing neuromodulators, they end up in a zone of undertreatment for a period of time.

Specifically with facial Injectables, you think about the time that people have at home and times to getting the practices. While their flow has changed people are getting more procedures done at that at the office at a time and so patient flow seems to be pretty good we're keeping an eye on the trends in certain markets as we see upticks, but right now we feel like the offices are in a good position to to match.

Mark J. Foley: So, we actually think that with a product with this duration profile, physicians will be able to charge more, patients will come in, you know, probably at a frequency level that's consistent with what they do today, and so everybody wins. The patient pays a little more for it, gets, you know, a longer duration of the effect that they're paying to come in for, physicians make more per visit, and we do well as a manufacturer driving innovation. Again, we're looking to segment the market. I don't expect that in an account they'll switch everything out, but we believe that there's a healthy part of the market that will opt in to sort of this prestige or premium product offering, and we think they can coexist.

And any new restrictions and other things that caught by surprise before but now they really have been thoughtful about how do they manage their staff how do they manage the flow of the practice so they're fairly they're in a good position on the Rhj side similar to what I mentioned before we really want the innovation to speak for itself in terms of how you drive the price.

Going to the consumer so we do believe that already chase a premium priced product to the consumer the practices set that price and so what we've seen is a slight five.

5% to 10% premium to the consumer now again, we have a policy uniquely set to revamp its where we don't allow for that price to be advertised. So therefore that the consumer gets its information by who delivers the best outcomes versus who is going to deliver the best price. We feel that philosophy is is resonating as really allowing us to focus on the subs.

Out of accounts and so however to pricing to the Doctor is really in line with currently marketed hyaluronic acid products, which allows the margin in the practice to be at or above where they are at with current products.

Mark J. Foley: If you look at a lot of accounts today, they will end up with more than one neuromodulator on the shelf; they'll have, you know, one or two different fillers on the shelf, and so they will offer the products that they think resonate the most with consumers, and so we think this sort of premium or prestige strategy really resonates really well and aligns with our market data, and we'll obviously give out the pricing information as we get into the launch In terms of the CD side of things and what's causing the timing there, you know, we talked about completion of our enrollment in the open label study in August of this past year. We now need to complete all the follow-ups.

Got it thank you.

Correct.

Your next question comes from the line of velocity per site with Barclays.

Hi, good afternoon. Thanks for taking my questions most of it has been answered.

Mark J. Foley: We then have to have the end of phase three meeting with the FDA. We talked about a submission in 2022 and then an approval in 2023, so that's just basically driven by completing the trial, wrapping up the data, meeting with the agency, and so that's kind of how we get to that timeline. On the PF and sort of some of the changes that we made, you know, as you referenced, this is our second phase two PF study. In the first PF study that we ran, we again saw really good pain reduction with both treatment groups, but we saw a surprisingly high placebo response rate. So the changes that we made were designed to try and better separate out placebo from treatment.

Just couple of questions left on into MB. So can you kind of connect the total amount of payment process, which you mentioned was $100 million to the revenues that you reported which is around $2.2 million I thought the opportunity for you as the main 0.5% to one person that this seems more.

0.2% again on a sinus holidays.

And secondly on that the the question that we're getting the most is on.

Label on what April mentioned on the duration.

And Scott can you help us understand what we ought to be looking forward is that going to be explicit mention on the label or is it more indebted delve and that is that contraindication for less than 24 week sales are something along those lines. Thank you yes.

Yes will actually a great question. So first on the hand MD side of it. We've previously talked about sort of the overall credit card transaction processing charge and that that we would expect to participate in 50 to 100 basis points. So if you go to the low end of that Youre talking $500000 in payment processing revenue between the beginning of the.

Mark J. Foley: Again, in this phase two study, we showed really good pain reduction in both treatment arms but again an unusually high placebo response rate. And so we had done a variety of things. You know, before we injected both the calf and the heel, we went to just the heel because the calf can be a trigger point release for dry needling, and we thought maybe we could do that. We changed the way we did the inclusion criteria to make sure that we were capturing those with true plantar fasciitis pain. Rather than just measuring one single point in time for the pain measurement, we did it over the course of five days so that we tried to make sure that we captured it.

Year end, where we are today, so actually that $200000 in Q3 lines up pretty well with sort of the transaction processing side of things doing it yes, and just just to note that that $100 million cumulative for the year Twentytwenty and the revenue number is in Q3 post hint.

Mark J. Foley: Unfortunately, despite the changes that we made with really good input from a lot of clinicians out there and insight, we again ended up with a really high placebo response rate. So we're disappointed that the product performed well and showed a really good, you know, safety profile as well. But, you know, I think that as we've gone back and we've sort of, you know, reflected on things, plantar fasciitis is a very different physiology. You know, it's inflammation of the plantar fascia.

Acquisition, close which was close to 20 Threerd of July Twentytwenty.

Got it on the shelf. So that's very much in line and we continue to feel good about that as we've talked before too I think how we allocate ultimately that revenue stream whether we.

Choose to figure out partnering ways that could evolve over time, but we continue to feel very good with sort of the the revenue that we are generating from the payment value. That's being generated your question about the label I think that falls in the category of which is not appropriate for us to be commenting on kind of discussions with the agency. However, I will refer you back to.

Mark J. Foley: It's secondary to injury. There are a lot of other things going on, and if we look at our other programs in muscle movement and, you know, existing indications for pain, those are categories which are much better characterized, and the performance of neuromodulators in those categories makes sense. And, you know, for us right now, the thing that we've demonstrated in two phase three trials is an encouraging duration profile. So I think focusing on those indications that are known where our product profile has an opportunity to be very competitive is a more judicious investment of our resources and time. We will, to your point, do some additional subset analysis to see if there's other things that we can glean from it. But I think with where we are today, we're again going to focus more on kind of the muscle movement and existing indications as sort of our primary focus. And then the last one you had was on the RHA and the NMD and, you know, a combination of the two. I mean, it's early right now.

Prior commentary that we had if you look at the quality of our sucker, one and two programs the largest ever in Glabellar lines.

Guidance from the agency precedent labels feedback that we've had we continue to feel very good about the data from our trials being reflected in the label so.

Thats.

Other than sort of the inspection update where we are going to kind of follow our typical policy in terms of not commenting on active discussions with the agency.

That's helpful and then I found that just one follow up on.

Planned upside does.

So with regard to migraine are there any dietary inadequate tools from from planned also cited studies towards how you develop the data the chronic migraine program. When you think of starting it. Thanks, Dan. Thanks, Yes, that's a great question BACE and of course. It is one of the things that we looked at you know in terms of the phase two results.

Mark J. Foley: We took two disparate organizations and put them together. We think we've done a great job of distilling down the message, making sure that we can get leverage where possible. But we're early on that. We think that the products that we're introducing into the market fit very well with the discussion around services that can help practices, and vice versa. So while it's early, you know, we do believe that there will be some pretty good synergies that we can unlock as we move forward. But it's still early, and I think there will be more to come as we move forward. Your next question comes from the line of Tim Lugo with William Blair. Thanks for taking the questions. And I just want to confirm if you know if the inspectors would need to come out.

Sales and plantar fasciitis are there any read throughs into the other programs again, I think that the underlying physiology of plantar fasciitis is very different it's a factual disease at secondary injury.

It's not all that well understood we certainly looked at.

Some of the data that have been published talked to some clinicians as to why we thought it could be a good treatment opportunity, but it is very different from currently approved indications in muscle movement in pain disorders and so.

We don't think it in any way impacts the way that we view the existing opportunities or frankly, our ability to have a differentiated and.

Timothy Francis Lugo: And they're not regional inspectors; I know that there's been a movement kind of away from local inspectors and more towards national teams depending on the indications and I guess product or if you're just producing the travel restrictions are what is the what is the hurdle and maybe you mentioned this already, but can you just confirm if the inspection is the last major issue outstanding in the review? Yeah, so Tim, great question. So in terms of what we've heard from the agency, what they have confirmed is that they will need to perform a site inspection.

In sort of opportunity in those markets, where a longer duration product we have value. So has it changed the way that we think about migraine and again it continues to be not as if when strategy clearly with where we are with CD and the data that we have coming out and you have less that phase two data in Q1 that will help inform sort of our go to market strategy on those.

Gross and then kind of when we layer in the start of these other clinical programs, we'll give more clarity as we start from those up.

Okay, great. Thanks.

Your next question comes from the line of Doug So.

C. Wainwright.

Hey, how are you doing Chris bills on for Doug today.

Mark J. Foley: I That has to do with the fact that we have not qualified this manufacturing site for any other products. So this will be our first approval, which is why an inspection does need to take place. You know, what they pointed us to is, you know, kind of their prior guidance saying that, you know, here's sort of the guidance we've got, you know, Protocols we've got to follow, and that travel-related restrictions will impact that. That's basically what we know today.

So I was wondering if there is a delay in the deck CBLI how could this impact the commercial plans for the seller liner into Mds I remember you guys mentioned that you were going to co promote all three.

What plans are what contingency do you have in the event of a potential delay to mitigate this thanks.

Yes, so great question.

Unfortunately, we've already been through this once with sort of the delay in the launch of the Rhj filler line due to Covance already.

Mark J. Foley: We are continuing to work proactively. Our PDUFA date has not come yet. We're still hopeful that perhaps the inspection will take place prior to them. But as we mentioned earlier, with now being 16 days away from the PDUFA and no site visit scheduled, knowing that we need to have one, we thought it was appropriate to share it with it. Again, we do feel good that we're a U.S. single-site manufacturing facility here in Northern California.

Theres always going to be puts and takes when there is something that impacts. It. So again I want to restate, we don't know whether or not there will be a delight. We're still hopeful that there will be an inspection before our PDUFA date.

But if there is what we've talked about is first and foremost we're an incredibly strong cash position. So we've got.

Now almost $450 million as of the end of Q3.

We feel really good about sort of our ability to execute on the launch so thats kind of number one number two when we talked about sort of the launch plan for our neuromodulator, we talked about Q1 being sort of a limited with a small group to inform kind of you know.

Mark J. Foley: So we are anxiously awaiting that. We've not commented on any other details surrounding the actual BLA submission. We don't think it's appropriate, other than to say that we continue to feel very good about the quality of the submission that we've put in, and we continue to work collaboratively with the agency. And was there a second part to the question? I guess you maybe touched on it, if it was the kind of last outstanding issue for the review, but it sounds like you're very confident with the quality. You know, if you were, if an inspection were to occur tomorrow, and there were some 443s, would you even be able to turn them around, given the schedule? And should we just kind of assume a delay as of now? I mean, great questions.

Optimal approach Q2 being sort of the pre launch of 100 injectors, and then Q3 being a lot similar to what we're going through right now with the Rhj fillers and so if we look at that timeframe. Obviously, if there if there were to be a delay we'd be looking at ways to see whether or not we can compress any of that.

And if there are ways to minimize any kind of impact.

However, it does help to be in the market with two great products with the Archie fillers in the hint MD and while certainly the three together.

We'll add additional leverage from up.

Timothy Francis Lugo: I think we're theorizing. I think we're just trying to share what information we definitely know. I think that as we start getting into the, you know, potential for this or that, it's hard to say we're not on the clock. I know this is sort of atypical to report this out prior to the PDUFA date, but we just thought it was the appropriate thing to do given the company update, so it's hard to theorize sort of whether or not we could if there's anything that were to come up, but we You did $2.8 million in RHA revenue this quarter, but it was only a partial quarter.

A bundling perspective.

You know if anything it allows us a little bit more focus right now in these both these products in the early stages of their launch where we can make sure that we get the necessary traction and focus and adoption of these platforms.

I don't think that adding our neuromodulator in any way sort of changes that and really becomes additive over time. So.

We wish we have more clarity on this we're ready like I said whenever whenever they show up for the inspection and we've got we think a really good opportunity to mitigate any impact because of our dollars because of our end market assets and sort of our current launch strategy.

Timothy Francis Lugo: What was kind of the underlying demand and should we, you know, should we assume that it, you know, the demand might be 6 million and build off of there, or can you just talk about if there was any kind of one-time loading or inventory stocking in that number? Yeah, so great question. I think that's why we're just not in a position to give guidance yet, because it is still early. I mean, the RHA sales really reflect our sales in September. But, you know, as you can imagine, these are initial purchases where, if you look at the buying patterns for fillers, they, you know, every account's a little bit different. But given the fact that it's a new product, they tend to order a reasonable amount of products, so they can get a really good experience with it.

Oh, Thank you very much great. Thank you.

And you have no further questions at this time I will now turn the call back over to Mr. Mark Foley.

Great. Thank you operator before year end, we plan to virtually attend the credit Suisse Stifel and Piper Sandler healthcare conferences. We welcome your request for meetings at these events are directly through us feel free to reach out to Genie, if you'd like to schedule some time.

With that I would like to thank you all for participating in today's call.

Timothy Francis Lugo: So I don't think that you should take sort of the September month and multiply it by three for Q4, because these are early accounts that, you know, our reps know that we're going to. Again, we're very focused on going deep, not wide, to make sure that people that, you know, partner with us are very committed to sort of this, you know, premium category that we're looking to create. So I just, I think it's early right now.

Ladies and gentlemen, thank.

Conclude today's conference call.

Thank you for participating and you may now disconnect.

Serge D. Belanger: Again, it's obviously a very strong start, given one month of launch, and the feedback we're getting is very positive. But it's just, it's a little bit too early to know what that reorder cycle is going to look like, and what the stickiness of the product is going to be. And, you know, certainly, we'll be able to give you more insight into that as we, as we report out our Q4 numbers. Thank you for the clarification. Thanks, Tim. Your next question comes from the line of Serge Belanger with Needham & Company. Hi, good afternoon.

Serge D. Belanger: Just a couple of questions for me. The first one for Mark or Dustin: can you just talk about current patient flow levels? Have they recovered from, where have they recovered from pre-COVID levels, and are they still recovering through, I guess, mid-fourth quarter? And then, secondly, on the RHA filler pricing, can you tell us where you have priced the product relative to the competition and what you're seeing physicians price the product for their consumers? Thanks. Thanks, Serge. This is Dustin.

Dustin S. Sjuts: I think on patient flow. I think we talked a little bit about it on the HintMD side as well. We've been really pleasantly surprised that patient flow is coming back. Of course, some practices are different, but in most states, we're seeing that the aesthetic practices are doing well, even right at or above pre-COVID levels. Specifically, with facial injectables, you think about the time that people have at home and the times to get into practices. While their flow has changed, people are getting more procedures done at the office at a time, and so patient flow seems to be pretty good. We're keeping an eye on the trends in certain markets as we see upticks. But right now, we feel like the offices are in a good position to manage any new restrictions and other things. They caught them by surprise before, but now they really have been thoughtful about how they manage their staff, and how they manage the flow of the practice. So they're in a good position. Outcomes versus who's going to deliver the best price.

Dustin S. Sjuts: We feel that philosophy is responding. It's really allowing us to focus on a subset of accounts. So, however, pricing to the doctor is really in line with currently marketed hyaluronic acid products, which allows the margin in the practice to be at or above where they're at with current products.

Dustin S. Sjuts: Thank you. Your next question comes from the line of Balaji Prasad with Barclays. Hi, good afternoon.

Balaji V. Prasad: Thanks for taking my questions. Most of them have been answered. Just a couple of questions left on Intem D. So can you kind of connect the total amount of the payment process, which you mentioned was $100 million, to the revenues that you reported, which is around $0.2 million. I thought the opportunity for you was between 0.5% to 1%, but this seems more at 0.2%. Again, I understand it's early days. And secondly, on DAXI, the question that we get the most is on the label and what it would mention about the duration. And so, can you help us understand what we have to be looking for? Is there going to be explicit mention of the label, or is it more indirect where there is a contraindication for less than 24 weeks of use, or something along those lines? Thank you. Yeah, Balaji, a great question.

Mark J. Foley: So first on the HIN-MD side of it, you know, we've previously talked about sort of the overall credit card transaction processing charge, and that of that, we would expect to participate in 50 to 100 basis points. So if you go to the low end of that, you're talking $500,000 in payment processing revenue between the beginning of the year and where we are today. So actually, that $200,000 in Q3 lines up pretty well with sort of the transaction processing side of things. Yeah, and just to note that that $100 million is cumulative for the year 2020. And the revenue number is in Q3 post the HINT acquisition close, which was closed on the 23rd of July 2020.

Mark J. Foley: So that's very much in line, and we continue to feel good about that. As we've talked before, too, I think how we allocate that revenue stream, whether we choose to figure out partnering ways, that could evolve over time, but we continue to feel very good with sort of the revenue that we're generating from the payment value that's being generated. Your question about the label, I think that falls in the category of it's just not appropriate for us to be commenting on discussions with the agency. However, I will refer you back to prior commentary that we had.

Mark J. Foley: If you look at the quality of our Sakura 1 and 2 programs, the largest ever in Globelar Lines, guidance from the agency, precedent labels, and feedback that we've had, we continue to feel very good about the data from our trials being reflected in the label. So that's what we're doing. You know, other than sort of the inspection update, we're going to kind of follow our typical policy in terms of, you know, not commenting on active discussions with the agency. That's helpful, Mark. I can understand that. Here is just one follow-up on plantar fasciitis. So, with regard to migraine, are there any direct or indirect read-throughs from plantar fasciitis studies towards how you will develop the chronic migraine program when you think of starting it next year?

Balaji V. Prasad: Thanks. Yeah, no, that's a great question, Balaji. And, of course, that's one of the things that we looked at, you know, in terms of, you know, the Phase II results in plantar fasciitis. Are there any read-throughs into the other programs? Again, I think that the underlying physiology of plantar fasciitis is very different. It's a fascial disease.

Mark J. Foley: It's secondary to injury. It's not all that well understood. We certainly looked at some of the data that had been published, talked to some clinicians as to why we thought it could be a good treatment opportunity. But it is very different from currently approved indications in muscle movement and pain disorders.

Mark J. Foley: And so we don't think it in any way impacts the way that we view the existing opportunities or, frankly, our ability to have a differentiated and sort of opportunity in those markets where a longer-duration product would have value. So has it changed the way that we think about migraine?

Mark J. Foley: And, again, it continues to be not an if but a when strategy. Clearly, with where we are with CD and the data that we have coming out in ULS, that Phase II data in Q1 will help inform sort of our go-to-market strategy on those. And then kind of when we layer in the start of these other clinical programs, we'll get more clarity as we start to firm those up. Thank you. Great. Your next question comes from the line-up Doug Tsao with HC Wainwright. Hey, how are you doing? Chris Bialasan here for Doug today.

Douglas Dylan Tsao: So I was wondering if there's a delay in DACS-TBLA, how could this impact the commercial plans for the filler line or Indemn-DIA? I remember you guys mentioning that you were going to co-promote all three, and what plans or what contingencies do you have in the event of a potential delay to mitigate this? Thanks.

Mark J. Foley: You know, so great question, unfortunately, we've already been through this once with the sort of delay in the launch of the RHA filler line due to COVID already. You know, there's always going to be puts and takes when there's something that impacts it. So again, I want to restate, you know, we don't know whether or not there will be a delay. We're still hopeful that there will be an inspection before our PDUFA date. But if there is, what we've talked about is, first and foremost, we have an incredibly strong cash position. So we've got, you know, almost $450 million as of the end of Q3. We feel really good about sort of our ability to execute on the launch. So that's kind of number one.

Mark J. Foley: Number two, you know, when we talked about sort of the launch plan for our neuromodulator, we talked about Q1 being sort of limited with a small group to inform kind of the optimal approach, Q2 being sort of the preview launch of 100 injectors, and then Q3 being a launch similar to what we're going through right now with the RHA fillers. And so if we look at that timeframe, obviously, if there were to be a delay, we'd be looking at ways to see whether or not we can compress any of that. And if there are ways to minimize any kind of impact.

Mark J. Foley: However, it does help to be in the market with two great products with the RHA fillers in the HINT-MD. And while certainly the three together will add additional leverage from a, you know, a bundling perspective, if anything, it allows us a little bit more focus right now on these two products in the early stages of their launch, where we can make sure that we get the necessary traction, focus, and adoption of these platforms. I don't think that, you know, adding our neuromodulator in any way sort of changes that and really becomes additive over time.

Mark J. Foley: So, you know, we wish we had more clarity on this. We're ready, like I said, whenever they show up for the inspection. And we've got, you know, we think a really good opportunity to mitigate any impact because of our dollars, because of our in-market assets, and sort of our current launch strategy.

Mark J. Foley: Thank you very much. Great. And do you have any further questions at this time? I will now turn the call back over to Mr. Mark Foley.

Mark J. Foley: Thank you, Operator. Before year-end, we plan to virtually attend the Credit Suisse, Stiepel, and Piper Sandler Health Care Conferences. We welcome your requests for meetings at these events or directly through us. Feel free to reach out to Jeanne if you'd like to schedule some time. With that, I would like to thank you all for participating in today's call. Ladies and gentlemen, this concludes today's conference call. Thank you for participating, and you may now disconnect.