Q2 2020 Revance Therapeutics Inc Earnings Call

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Operator: At this time, all participants are in a listen-only mode. Following management's prepared remarks, we will hold a question and answer session. To ask a question at that time, you'll need to press star one on your touchtone telephone. If anyone has any difficulty hearing the conference, please press star then zero for operator assistance. As a reminder, today's call is being recorded today, August 5th, 2020. I would now like to turn the call over to Jenny Herbert, Head of Investor Relations and Corporate Communications for Revance. Please go ahead.

At this time all participants are in listen only mode. Following management's prepared remarks, we will hold the question and answer session to ask a question at that time, you'll need to press star one on your touched on telephone if anyone has any difficulty hearing the conference. Please press Star then zero for operator assistance as a reminder, today's call is being recorded today.

Yes it.

2020, I would now like to turn the call over to Jeanie Herbert head of.

The Investor Relations a corporate communications forbids. Please go ahead.

Unknown Executive: Thank you, Jonathan. 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, and Chief Commercial Officer of Aesthetics and Therapeutics Dustin Sjuts. Earlier today, Revance released financial results for the second quarter ended June 30, 2020. If you have not received this news release or you would like to be added to the company's distribution list to receive future releases, please go to the Investor Relations section of Revance's website, which can be found at www.revance.com.

Thank you Jonathan joining us on the call today from rebalance, our President and Chief Executive Officer, Mark fully Chief Financial Officer Tobi Ltke.

Operating officer, and President of R&D, and chronic operations Dr., API, Josie and Chief commercial officer of a static some therapeutics Dustin.

Earlier today Revamps released financial results for the second quarter ended June Thirtyth 2020, if you've not received this news release or you would like to be added to the company's distribution list to receive feature releases. Please go to the Investor Relations section of romances website, which can be found at www dot refinanced.

Dotcom.

Unknown Executive: During the conference call, management will make forward-looking statements, including statements related to Revance's 2020 financial results and guidance, the clinical development of our product candidates, business strategies and planned operations, anticipated pre-commercialization and launch plans, financial estimates with respect to the Teoxane distribution agreement and the HintMD acquisition, and potential product candidates and technologies. These forward-looking statements are based on the company's current expectations and inherently involve significant risks and 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 those expressed include factors the company describes in the section titled Risk Factors in our current report on Form 10-Q, to be filed this afternoon, August 6, 2020. Revance cautions you not to place undue reliance on forward-looking statements and undertakes no duty or obligation to update any forward-looking statements as a result of new information, future events, or changes in its expectations.

During the conference call management will make forward looking statements, including statements related to the answer is 2020 financial results and guidance.

The clinical development of our product candidates business strategies and planned operations anticipated pre commercialization and launch plan.

Financial estimates with respect to the T. Oxy distribution agreement and the here.

M.D. acquisition and potential product candidates and technologies. These forward looking statements are based on the company's current expectations and inherently involve significant risks and uncertainties, our actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks.

And uncertainties.

Factors that could cause results to be different from these statements include factors. The company describes in the section titled Risk factors in our current report on form 10-Q to be filed this afternoon August six 2020.

Advanced cautions you not to place undue.

Reliance on forward looking statements and undertakes no duty or obligation to update any forward looking statements as result of new information future events or changes in its expectations that I'll now turn the call over to Mark Foley Mark.

Mark J. Foley: With that, I'll now turn the call over to Mark Foley. Mark?

Mark J. Foley: Thank you, Jeannie. Welcome to our second quarter 2020 financial results and corporate update conference call. As we continue to deal with the COVID-19 pandemic, our businesses are constantly and successfully adjusting to new guidelines and safety procedures. Most of our people are working productively from home, and we have modified both our clinical and commercial strategies to most effectively operate within the evolving landscape. In most geographies, aesthetic practices have reopened with facial injectables in high demand. While office throughput is still constrained due to social distancing and cleaning regimens, we're hearing from physicians that patients are returning to their treatment routines, and some are requesting additional procedures to make up for lost time.

Thank you Jamie.

Welcome to our second quarter 2020 financial results in corporate update conference call.

As we continue to deal with the Kobin 19 pandemic, our businesses constantly and successfully adjusting to new guidelines and safety procedures.

Most of our people are working productively from home and we have modified both our clinical and commercial strategies to most effectively operate within evolving landscape.

In most geographies static practices of reopened with facial injectables in high demand.

Office throughput is still constrained due to social distancing in cleaning regimens. We're hearing from physicians that patients are returning to their treatment routines and some are requesting additional procedures to make up for last time.

Mark J. Foley: Overall, Revance is weathering the ongoing COVID situation with minor disruption and continues to operate from a position of great strength. In terms of our business, these are very exciting times. We're on the threshold of the company's very first commercial product launch as we prepare to introduce both the RHA collection of dermal fillers and HintMD FinTech platform in the U.S. market this quarter. In addition, we have a number of important clinical and regulatory tasks ahead for doxybotulinum toxin A per injection before year end.

Overall revamped as weathering the ongoing covance situation with minor disruption and continues to operate from a position of great strike.

In terms of our business. These are very exciting times.

We're on the threshold of the company's very first commercial product launch as we prepare to introduce both the Rhj collection of dermal fillers and hit MD Fin Tech platform in the U.S. market this quarter.

In addition, we have a number of important clinical and regulatory catalyst to head for doxey botulinum toxin day for injection before year end.

We are thrilled to provide you with an update on our second quarter accomplishments and update you on all that lies ahead for us in the second half of the year.

The most significant progress in the second quarter centered around the expansion in commercialization of our aesthetics franchise.

Mark J. Foley: We are thrilled to provide you with an update on our second quarter accomplishments and to update you on all that lies ahead for us in the second half of the year. The most significant progress in the second quarter centered around the expansion and commercialization of our aesthetics franchise. While COVID led to a one-quarter delay in our launch plan for the RHA collection of dermal fillers, we successfully used the time to dial in our launch strategy, complete the hiring of our commercial team, and build out our operational infrastructure. Late in the second quarter, we received our first shipment of RHA 2, 3, and 4 from Teoxane, ensuring a timely market introduction next month.

While cobot led to a one quarter delay in our launch plan for the RJ collection of dermal fillers, we successfully used the time to dial in our launch strategy complete the hiring of our commercial team and build out our operational infrastructure.

Late in the second quarter, we received our first shipment of our ha two three and four from T. oxaydo, ensuring a tightly market introduction next month.

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Having product for sampling allowed us to jump start to preview early clinical experience program focused on building experience and confidence with the full range of innovative Rhj fillers.

In May we announced an additional expansion of our statics franchise with the acquisition of the hit MD Fin Tech platform.

This payment processing subscription service and loyalty platform has a unique service component to our prestige product offering and allows us to better support our physician partners.

Mark J. Foley: Having product for sampling allowed us to jumpstart the PREVIEW Early Clinical Experience Program focused on building experience and confidence with the full range of innovative RHA fillers. In May, we announced an additional expansion of our Aesthetics franchise with the acquisition of the HintMD FinTech platform. This payment processing, subscription service, and loyalty platform adds a unique service component to our prestige product offering and allows us to better support our physician partners. We believe there is tremendous logic and value in this combination. NMD provides Revance with access to a $500 million vertical payment processing opportunity, allowing us to access a near-term recurring revenue stream. NMD's smart payment platform allows for secure, no-touch, point-of-sale payment processing, which is particularly relevant in today's COVID environment.

We believe there is tremendous logic and value in this combination.

Kennedy provides revamps with access to a 500 million dollar vertical payment processing opportunity.

Allowing us to access a near term recurring revenue stream.

Indeed, smart payment platform allows for secure no touch point of sale payment processing, which is particularly relevant in today's cobot environment.

The platform also enables customized subscription plans, allowing physicians to create a tailored treatment and payment plan for each patient.

Lastly hit was hit MD was designed as an open platform, meaning that it is able to integrate other brand loyalty programs and services offerings, which can increase adoption engagement and create operational efficiencies within our practice.

Importantly, we will leverage our new commercial infrastructure to launch the hidden be services in tandem with the Rx a collection of dermal fillers and upon approval doxey botulinum toxin a for injection.

We plan to leapfrog conventional brand loyalty programs by enabling practice centric loyalty programs made possible by very experienced hit MD software and technology team.

We officially close to hit MD deal on July 20, Threerd and are in the process of integrating their workforce and platform into the revamp structure.

Dustin S. Sjuts: The platform also enables customized subscription plans, allowing physicians to create a tailored treatment and payment plan for each patient. Lastly, HintMD was designed as an open platform, meaning that it is able to integrate other brand loyalty programs and services offerings, which can increase adoption, engagement, and create operational efficiencies within a practice. Importantly, we will leverage our new commercial infrastructure to launch the HIN-MD services in tandem with the RHA collection of dermal fillers and, upon approval, doxybotulinum toxin A for injection. We plan to leapfrog conventional brand loyalty programs by enabling practice-centric loyalty programs made possible by a very experienced TANMD software and technology team. We officially closed the HNMD deal on July 23rd and are in the process of integrating their workforce and platform into the revamped structure.

I'll be rank and co founder and CEO of hit MD is now our president of innovation and technology and will soon step onto our board of directors.

We are thrilled with the hinted be acquisition and believe that it will significantly enhance our ability to build a leading aesthetics franchise.

We will cover more on the hit MD and Rhj collection rollout with Dustin discusses our launch plans and just a minute.

Now let me make a brief statement on our lead asset Daxibotulinumtoxina day for injection, given the Kogan 19 environment.

Our PDUFA date productive botulinum toxin a for injection in Glabellar lines remains November 20, Fiveth and as such we're busy preparing for potential commercial launch of our next generation neuromodulator before year end.

As we entered the second half a year or commercial focus is on the introduction of our compelling offering first set of practices, which truly differentiated products and services. Let me now hand, the call over deducted to give you more details on our commercial launch Dustin.

Thanks, Mark in September Revamps will make the official leap from clinical stage two fully commercialized public entity, we are ready to ready and eager to officially introduce RJ collection. The first and only range of innovative Swiss made dermal fillers for the correction of dynamic facial wrinkles unfolds.

Dustin S. Sjuts: Aubrey Rankin, Co-Founder and CEO of HenMD, is now our President of Innovation and Technology and will soon step onto our Board of Directors. We are thrilled with the Henn-MD acquisition and believe that it will significantly enhance our ability to build a leading aesthetics franchise. We'll cover more on the NMD and RHA collection rollout when Dustin discusses our launch plans in just a minute. Now, let me make a brief statement on our lead asset, Daxibotulinum toxin A for injection, given the COVID-19 environment. Our Piducidate-Prodoxybotulinum toxin A for injection in glabellar lines remains November 25th, and as such, we are busy preparing for a potential commercial launch of our next generation neuromodulator before year end. As we enter the second half of the year, our commercial focus is on the introduction of our compelling offering for aesthetic practices with truly differentiated products and services. Let me now hand the call over to Dustin to give you more details on our commercial launch.

I'll cover it has an impact on the market. Our strategy has not changed we have successfully moved all of central launch programs and commercial operation activities forward to set the foundation for multiple product and service launches as we enter fall.

Our first order RJ collection product was shipped from Switzerland pass through customs proceeded through our supply chain and was delivered in the hands of answers first trainers and customers.

And successfully built tested and operationalized, our entire commercial infrastructure, including international supply chain operations customer service ecommerce platform sampling fulfillment and other key infrastructure elements all of which culminated in a successful processing of multiple sales and sample orders.

Our field force build out just complete despite the environment, we successfully hired our entire customer facing organization virtually 100, plus experienced professionals, who are currently in the process of training and will soon be engaging with the doctors across the country.

With the RJ collection now in the country, our engagement with key positions has transitioned from operation resilience in March two an in depth clinical education program for select acquisitions over the past two months through the Rhj collection preview program, we've already introduced and trained more than 100 key opinion leaders and Influencers on our.

Dustin S. Sjuts: Thanks, Mark. In September, Revance will make the official leap from the clinical stage to a fully commercialized public entity. We are ready and eager to officially introduce the RHA Collection, the first and only range of innovative Swiss-made dermal fillers for the correction of dynamic facial wrinkles and folds. While COVID has an impact on the market, our strategy has not changed. We have successfully moved all essential launch programs and commercial operation activities forward to set the foundation for multiple product and service launches as we enter fall. Our first order of RHA collection product was shipped from Switzerland, passed through customs, proceeded through our supply chain, and was delivered to Revance's first trainers and customers. Revance successfully built, tested, and operationalized our entire commercial infrastructure, including international supply chain operations, customer service, e-commerce platform, sampling fulfillment, and other key infrastructure elements, all of which culminated in the successful processing of multiple sales and sample orders. Our field force build-out is complete.

Hey, two three and for.

This group represent a prominent and sample of thought leaders in the aesthetic community. They are collecting robust clinical experience and providing feedback that will form and enhance our full rollout plan for September we look forward to sharing some of these preview insights with you as the program comes to completion in the fall.

In tandem with preparations to launch the RJ collection, we have completed the game changing fintech acquisition of him to which will complement our planned product launches this year.

We plan to build upon the existing installed base of pilot hinting to users through an introduction to select aesthetic accounts across the us beginning in September.

We have sampled our products tested our infrastructure initiated training of our people and are now ready to go.

Our of Anesthetics launch strategy is clear keep the physician at the center of everything we do our plans and strategies were developed to relieve the many pressures physicians have in a growing market.

We recognize the innovation gaps that exist in both the dermal fillers and neuromodulator market and its inherent impact on to monetization.

Dustin S. Sjuts: Despite the environment, we successfully hired our entire customer-facing organization virtually, 100-plus experienced professionals who are currently in the process of training and will soon be engaging with doctors across the country. With the RHA Collection now in the country, our engagement with key physicians has transitioned from Operation Resilience in March to an in-depth clinical education program for select physicians. Over the past two months, through the RHA Collection Preview Program, we have already introduced and trained more than 100 key opinion leaders and influencers at RHA 2, 3, and 4. This group represents a prominent ensemble of thought leaders in the aesthetic community.

Positions have increasing competition as manufacturers train more and more injectors each year, demonstrating their agnostic approach to physician segmentation.

Position profits are eroding as conventional manufacturers are creating a coupon economy for physician loyalty take it back seat to discounts and patient outcomes and experience.

As we address these physician pressures with our go to market strategy. Our immediate focus is on a targeted professional launch for the innovative RJ collection in September which will include adaptable deliverables that can be deployed with virtual live in salt small group engagements.

Towards the end of the year subject to approval, we plan to implement a similar launch strategy for Daxibotulinumtoxina a for injection in the treatment of Glabellar lines or frown lines, starting with the phase preview program for select group of physicians, followed by a phased broader launch.

Dustin S. Sjuts: They are collecting robust clinical experience and providing feedback that will inform and enhance our full rollout plan for September. We look forward to sharing some of these early insights with you as the program comes to completion in the fall. In tandem with preparations to launch the RHA collection, we have completed the game-changing FinTech acquisition of HintMD, which will complement our planned product launches this year. We plan to build upon the existing installed base of pilot HintMD users through an introduction to select aesthetic accounts across the U.S. beginning in September. We have sampled our products, tested our infrastructure, initiated training of our people, and are now ready to go. Our Revance Aesthetics launch strategy is clear. We keep the physician at the center of everything we do.

Prior to the anticipated approval of Daxibotulinumtoxina, a for injection and frown lines. We undertook three phase two open label trial in the upper face to provide further insights on the performance of this next generation Neuromodulator product in late June we announced topline results from our phase two open label studies in Fourq.

Lines and crow's feet Daxibotulinumtoxina, a for injection demonstrated a measurable treatment effect on both forehead lines and crow's feet in fact and weak for at least one of the dose groups, 100% of these subjects had at least a one point change from baseline in Regal severity as assessed by the investigator.

In terms of duration of effect defined as the medium time to return a baseline wrinkle severity based on both investigator and patient assessment at least one dose in each study demonstrated a median duration of effect of 27 weeks in the forehead lines study and 24 weeks in a crow's feet study. These four week data from these studies.

Was used to optimize dosing and injection patterns for ongoing phase two open label Upper facial lines study and we expect to report that result in the fourth quarter.

Dustin S. Sjuts: Our plans and strategies were developed to relieve the many pressures physicians have in a growing market. We recognize the innovation gaps that exist in both the dermal filler and neuromodulator market and their inherent impact on commoditization. Physicians have increasing competition as manufacturers train more and more injectors each year, demonstrating their agnostic approach to physician segmentation. Physician profits are eroding as conventional manufacturers are creating a coupon economy where physician loyalty takes a backseat to discounts and patient outcomes and experience.

The magnitude of our static commercial progress in light of such a unique times is significant. These achievements are the result of synergistic teamwork among world class talent deliberate planning rapid execution and collective alignment to our mission.

All this gives me great confidence that Revance has the products strategy and a people to make a real difference in the year ahead with that I'll now turn the call back to Mark.

Thanks Dustin.

Now let me cover the progress we are making it our therapeutics franchise.

Our overarching strategies to leverage our core asset that few botulinum toxin a for injection and its differentiated duration profile by pursuing a number of different therapeutic indications, where the benefits of the product have the ability to significantly improve the duration of symptom relief for patients suffering from a number of debilitating.

Additions, while also providing a favorable cost profile to the healthcare system.

Dustin S. Sjuts: As we address these physician pressures with our go-to-market strategy, our immediate focus is on a targeted professional launch for the innovative RHA collection in September, which will include adaptable deliverables that can be deployed with virtual, live, and small-group engagement. Toward the end of the year, subject to approval, we plan to implement a similar launch strategy for daxibotulinum toxin A4 injection for the treatment of gobeler lines or frown lines, starting with a phased preview program for a select group of physicians, followed by a phased, broader launch. Prior to the anticipated approval of Daxibotulinum Toxin A for injection in frown lines, we undertook three Phase II open-label trials in the upper face to provide further insights on the performance of this next-generation neuromodulator product.

Based on recently reported industry research and our own internal market data in cervical dystonia and upper limb spasticity a longer duration neuromodulator has the ability to provide significant benefit to both patients and their caregivers due to the frequency of symptom recurrence in between injection cycles to that end.

I'm pleased to say that we're on track to report clinical data from three therapeutics programs in the next six months.

First we continue to expect topline results from the outspend, one phase III cervical dystonia pivotal trial in the fall.

And in June we completed the enrollment for the companion Aspen Open label long term safety study, which puts us in good shape for our first therapeutic regulatory filing.

These results in cervical dystonia will not only provide us with insights into the potential for daxibotulinumtoxina per injection in this indication, but will also help and performance potential in other muscle movement disorders, which collectively make up a $1 billion market worldwide.

Second also this fall we expect to report the topline results from our phase two plantar fasciitis trial.

Dustin S. Sjuts: In late June, we announced top-line results from our Phase II open-label studies in forehead lines and crow's feet. Daxibotulinum Toxin A for injection demonstrated a measurable treatment effect in both forehead lines and crow's feet. In fact, at Week 4, in at least one of the dose groups, 100% of these subjects had at least a one-point change from baseline in wrinkle severity as assessed by the investigators. In terms of duration of effect, defined as the medium time to return to baseline wrinkle severity based on both investigator and patient assessment. At least one dose in each study demonstrated a median duration of effect of 27 weeks in the forehead line study and 24 weeks in the crow's feet study. These four-week data from these studies was used to optimize dosing and injection patterns for our ongoing Phase II open-label upper facial line study, and we expect to report that result in the fourth quarter.

Tighter fasciitis is a painful reflection of the foot and he'll with one in 10 people in the us expected to get plantar fasciitis and their lifetime.

Currently there are no FDA approved drug treatments for plantar fasciitis. So it is a true white space and we look forward to the topline readout in this distinct pain indication.

And third in June we announced that we completed enrollment from modified Juniper phase two trial of Daxibotulinumtoxina per injection for the treatment of adult upper limb spasticity.

Due to ongoing cobot 19 concerns related to subject enrollment and scheduling in person study visits we chose to end screening in our juniper upper limb spasticity trial with a total of 83 subjects enrolled we believe our proactive and pragmatic decision to complete enrollment will allow us to report topline data in early.

The 2021 and potentially move into a pivotal phase three upper limb spasticity trial sooner than originally planned.

Overall, I'm very pleased with the status of our Therapeutics program and we look forward to sharing the topline results from these three clinical trials in the not too distant future.

Ill now turn the call over to Toby to summarize our financial results.

Afterwards, I'll have a few closing comments before we begin todays QNX session. Toby. Thank you Mark starting with our cash cash equivalents and short term investments balance we ended the second quarter with $494 million, which we believe is sufficient to fund our planned operations into 2023.

Dustin S. Sjuts: The magnitude of our aesthetic commercial progress in light of such a unique time is significant. These achievements are the result of synergistic teamwork among world-class talent, deliberate planning, rapid execution, and collective alignment to our mission. All this gives me great confidence that Revance has the products, the strategy, and the people to make a real difference in the year ahead. With that, I'll now turn the call back to Mark. Thanks, Doug.

This balance includes the $30 million milestone payment received as a result of my lands decision in May two opt into the development program for a biosimilar to botox.

Revenue for the second quarter of Twentytwenty consisted of $299000 in part of which comes from the recognition of our progress on our Milan collaboration and part of which represents our first initial sale of our ha collection for dermal fillers rhj product shipments.

Mark J. Foley: Thanks, Dustin. Now, let me cover the progress we are making in our therapeutics franchise. Our overarching strategy is to leverage our core asset, Daxibotulinum toxin A for injection, and its differentiated duration profile by pursuing a number of different therapeutic indications where the benefits of the product have the ability to significantly improve the duration of symptom relief for patients suffering from a number of debilitating conditions while also providing a favorable cost profile to the healthcare system. Based on recently reported industry research and our own internal market data in cervical dystonia and upper limb spasticity, a longer duration neuromodulator has the ability to provide significant benefit to both patients and their caregivers due to the frequency of symptom recurrence between injection cycles.

In connection with the preview program were less than $100000.

For the second quarter, our Opex was $57.4 million, excluding depreciation and amortization stock based compensation and the rhj related in process R&D, our opex was $48.6 million.

The earnings release, we issued today outlines our financial results and full so I will not go through the details on this call in terms of outlook. We are reiterating our twentytwenty guidance provided upon the hint empty acquisition announcement in May.

At that time, we noted that non-GAAP operating expense would be in the range of $220 million to $230 million. This excludes depreciation amortization stock based compensation and the rhj related in process R&D.

Mark J. Foley: To that end, I'm pleased to say that we're on track to report clinical data from three therapeutics programs in the next six months. First, we continue to expect top-line results from the Aspen 1 Phase 3 Cervical Dystonia Pivotal Trial in the fall. And in June, we completed enrollment in the companion Aspen Open Label Long-Term Safety Study, which puts us in good shape for our first therapeutic regulatory filing. These results in cervical dystonia will not only provide us with insights into the potential for daxibotulinum toxin A for injection in this indication but will also help inform its potential in other muscle movement disorders, which collectively make up a $1 billion market worldwide. Second, also this fall, we expect to report the top-line results from our Phase 2 plantar fasciitis trial. Plantar fasciitis is a painful affliction of the foot and heel, with 1 in 10 people in the U.S. expected to get plantar fasciitis in their lifetime. Currently, there are no FDA-approved drug treatments for plantar fasciitis, so this is a true white space, and we look forward to the top-line readout for this distinct pain indication.

We are developing our acquisition accounting for hint MD and once completed we can provide GAAP operating expense guidance for 2020 revamped still expects Twentytwenty non-GAAP research and development expense related to our non hint MD business to be $95 million to $100 million.

In terms of future revenue our policy remains to refrain from providing sales guidance until we can to determine the launch trajectory of our Rhj collection and the hint MD fin Tech platform, we will however, provide updates and metrics as we progress.

Finally revamp to shares outstanding as of July 24, 2020 were approximately $65.9 million with 72.1 million fully diluted shares excluding the impact of convertible debt with that I'll turn the call back tomorrow.

Thank you Toby.

This is a pivotal and exciting time at rebounds.

Having created what we believed to be a compelling portfolio of leading assets in aesthetics. We stand on the cost of commercialization not just of our Rhj collection of dermal fillers and hint MD Fintech platform, but also subject to approval of the world's first true next generation long acting neuromodulator Doxey box.

In line and talks in a for injection.

In tandem we've continued to invest in our therapeutics franchise with three important data readouts over the next six months all told we will be addressing markets totaling more than $6 billion worldwide.

Mark J. Foley: And third, in June, we announced that we completed enrollment for a modified Juniper Phase 2 trial of Daxibotulinum toxin A for injection for the treatment of adult upper limb spasticity. However, due to ongoing COVID-19 concerns related to subject enrollment and scheduling in-person study visits, we chose to end screening in our Juniper Upper Limb Spasticity Trial with a total of 83 subjects enrolled. We believe our proactive and pragmatic decision to complete enrollment will allow us to report top-line data in early 2021 and potentially move into a pivotal Phase III Upper Limb Spasticity Trial sooner than originally planned. Overall, I'm very pleased with the status of our therapeutics program, and we look forward to sharing the top-line results from these three clinical trials in the not-too-distant future. I will now turn the call over to Toby to summarize our financial results. Afterward, I'll have a few closing comments before we begin today's Q&A session. Toby.

I also want to note. We are excited about Mylans recent often decision to the Biosimilar to Botox program, which gives us a path forward to financially participate in the short acting neuromodulator category.

In summary, Ravens has weathered the cobot 19, cobot 19 situation very well with little impact on our operations or clinical timelines and a war chest of nearly $500 million in cash and investments funding us through our new product launches important therapeutic clinical readouts and into 2023.

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

Certainly once again, ladies and gentlemen, if you happy question at this time. Please press Star then one our first question comes from the line of Annabel Samimy from Stifel. Your question. Please.

Hi, everyone. This is avatar Jones on for Annabel.

One broader question.

Please sort of outline how the in the rollout will will enhance the thermal filler launch.

And specifically just mapping out those synergies or hurdles whatever they need the thank you.

It's a great question. So as we've commented in our prepared remarks, our goal is to leverage the commercial team that we put in place to launch the RLJ fillers.

We mentioned Weve hired all roughly 100 reps and so that group is going to be introducing the filler and will be a lead gen source for the hit MD platform and so we plan to create leverage in synergy and thats going to be our target customer base, which is kind of the prestige category and this targeted physician group.

Tobin C. Schilke: Thank you, Mark. Starting with our cash, cash equivalents, and short-term investments balance, we ended the second quarter with $494 million, which we believe is sufficient to fund our planned operations into 2023. This balance includes the $30 million milestone payment received as a result of MyLand's decision in May to opt-in to the development program for a biosimilar to Botox. Revenue for the second quarter of 2020 consisted of $299,000, part of which comes from the recognition of our progress on our MyLand collaboration and part of which represents our first initial sale of RHA collection for dermal fillers. The RHA product shipments in connection with the PREVIEW program were less than $100,000.

Excellent. Thank you.

Thank you. Our next question comes Milan, Terence Flynn from Goldman Sachs. Your question. Please.

Hi, Congrats on the progress thanks for taking my questions maybe.

Two for me was just wondering.

With respect to the fillers, if you can give us any guidance at this point on the gross margin side and then on the the Salesforce hiring any additional details you can share there regarding kind of.

Breadth of experience average years et cetera, and where these hires from other aesthetics companies, maybe a little bit more on their background and then.

Tobin C. Schilke: For the second quarter, our OPEX was $57.4 million. Excluding depreciation and amortization, stock-based compensation, and RHA-related in-process R&D, our OPEX was $48.6 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 outlook, we are reiterating our 2020 guidance provided in the HINT MD acquisition announcement in May. At that time, we noted that non-GAAP operating expenses would be in the range of $220 to $230 million. This excludes depreciation, amortization, stock-based compensation, and RHA-related in-process R&D.

Update on the status of the FDIC inspection for Deputy manufacturing. Thank you.

Great Terrence thanks for those questions, maybe I'll take one in three in hand to over to Duston. So first on the pillars on the gross margin I think thats getting into obviously, a sps and sort of cost of goods I think it's a little early right now to get into sort of the details of that once you sort of have launch trajectory. We're in the market will be better positioned to be able to give.

Metrics as we move forward so.

Just to remind you in terms of the nature of that relationship. It's a pure product transfer relationship where we acquire product from Taxane for set price and then based on what we sell it for that will ultimately determined our gross margin and then on the last one that you out just about sort of the FDA again as we commented on in our scripted comments right now we're still verifone.

Focused on our PDUFA date of November 25, Theres been no change on that it's sort of not company policy to talk about the specific details related to that.

Tobin C. Schilke: We are developing our acquisition accounting for HintMD, and once completed, we can provide GAAP operating expense guidance for 2020. Revance still expects 2020 non-GAAP research and development expenses related to our non HintMD business to be between 95 and $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 RHA collection and the HintMD FinTech platform. We will, however, provide updates and metrics as we progress. Finally, Revance's shares outstanding as of July 24, 2020, were approximately $65.9 million, with $72.1 million fully diluted shares, excluding the impact of convertible debt.

But we continue to March towards that date and at this point have anything that would suggest that there's anything other than that day to move towards.

With that went on I turn it over to Duston for your question on the Salesforce and some of the question do you have there yes. Thanks, Mark it's hard to Salesforce goes our strategy really was to select kind of the best of the best as it relates to experience, but those that also can deliver in the environment that we're getting into a competitive environment. Those that can create a category and also launched innovation and those skills.

That's our variable as it relates to different companies that they came from we actually had more than 9000 people applied to those hundred or so openings. We took that 9000 broken down to those that fit our profile and who would want to interview interviewed a select group of those and actually hired less than 5% of those admitted through that process. So we're very confident in the profile and we've hired.

As it relates to experience north of around 80% have aesthetic experience with more than half of those coming from the injectable market on the company specific wise, there's a variety of organizational experiences that came from so nothing one specific didnt standout all in all all that leads us to believe that we have the best Salesforce and I'm very confident in our ability to deliver on there.

Mark J. Foley: With that, I'll turn the call back to Mark.

Mark J. Foley: Thank you, Toby. This is a pivotal and exciting time at Revance. Having created what we believe to be a compelling portfolio of leading assets and aesthetics, we stand on the cusp of commercialization, not just of our RHA collection of dermal fillers and HINT MD FinTech platform but, subject to approval, the world's first true next generation long-acting neuromodulator, Daxibotulinum toxin A for injection. In tandem, we've continued to invest in our therapeutics franchise with three All told, we will be addressing markets totaling more than $6 billion worldwide. I also want to note that we are excited about Mylan's recent opt-in decision to the Biosimilar to Botox program, which gives us a path forward to financially participate in the short-acting neuromodulator category. In summary, Revance has weathered the COVID-19 situation very well, with little impact on our operations or clinical timelines, and a war chest of nearly $500 million in cash and investments, funding us through our new product launches, important therapeutic clinical readouts, and into 2023. With that, I will now open the call to questions. Operator.

Jay collection launched as well as with entity.

Does that answer your question.

Great. Thanks to our next.

Next question comes from the line of Stacy two from Cowen and company. Your question. Please.

Hi, Thanks for taking my questions and congratulations on the progress and so just a first question on the sellers do they have the same kind of brandloyaltys, how should we be thinking about the Lubbock awareness alright, alright.

This is clinicians versus consumer it I.

I guess.

More so just trying to think about the pacing at the seller.

And then how it might relate to the documents. Thanks.

Yes, great question so.

This is that first introduction of the already Ceight pillar line.

In the us so there's really not much familiarity awareness regarding the product certainly not in the consumer market. Some physicians are aware of it because the Archie filler line has been available in Europe and some other markets outside of your for quite some time in.

As physicians travel international meetings, they hear about new products, but really we're creating the brand here in the us and that's why we're taking a very disciplined approach to how we roll this out how we introduce it with any given geography theres going to be some differences in terms of the looked at are going for or injection technique and.

Our collective experience and certainly mine its eltek back in the Coolsculpting days that you need to build the foundation of success and that's what we're doing with this preview clinical program and so we will work closely with the right physicians to build it but we're going to need to build this brand here in the us.

Unknown Attendee: Certainly, once again, ladies and gentlemen, if you have a question at this time, please press star, then one. Our first question comes from the line of Annabel Samimy from Stiefel. Your question, please.

In terms of of how you look at the that Daxibotulinumtoxina for injection in that launch strategy, it's going to mirror a lot what we're doing on the Rhj solar side, we're taking a very methodical approach, where we're starting with the core group, we're getting them experienced with the product, we're using that engagement and feedback to inform some of the training and the targeting in the mapping that.

Unknown Attendee: Hi everyone, this is Avatar Jones on behalf of Annabelle. We have one broader question. Could you please sort of outline how the HINT-ND rollout will enhance the dermal...

We're going to do that will go into a phase launch and ultimately a broader launch and Thats really the same strategy that will ultimately take with.

Unknown Executive: and specifically just mapping out those synergies or hurdles, whatever they may be. Thank you. Yes, a great question. So you know, as we've commented in our prepared remarks, our goal is to leverage the commercial team that we put in place to launch the RHA fillers. You know, we mentioned we've hired roughly 100 reps. And so that group is going to be introducing the filler and will be a lead generation source for the HIN-MD platform. And so we plan to create leverage and synergy. And that's going to be our target customer base, which is a kind of prestige category in this targeted position group.

Our neuromodulator once approved.

Thank you.

Thank you.

Thank you. Our next question comes from a line of David Anthem from Piper Sandler Your question. Please.

Hi, Thanks so.

Quick question about sampling.

I guess this is sort of a high level question and just philosophically how aggressive you intend to be regarding sampling for both the.

They are ha fillers and also.

For DAC C.

Particularly in the context of this challenging macroeconomic environments and.

The lower off this throughput that you cited Mark and then my second question is.

On this idea of reduced office throughput and maybe that's something that you expect to be.

Unknown Executive: Excellent. Thank you.

Unknown Attendee: Thank you. Our next question comes from the line of Terence Flynn from Goldman Sachs. Your question, please.

Headwind as we move through 2021, I mean, how worried should we be about it.

Unknown Attendee: I congratulate you on all the progress. Thanks for taking the questions. Maybe two for me were just wondering, with respect to the fillers, if you can give us any guidance at this point on the gross margin side, and then on the Salesforce hiring, any additional details you can share there regarding the kind of breadth of experience as

In the context of two new launches thanks.

As maybe I'll take the first part of that and then handed over to dust and talk a little more specifically about the sampling side of it so with regards to sort of the throughput and does that have any spillover into sort of the way. We think about sampling of course, none of us as a crystal ball and it's really difficult to know for sure exactly how this is going to play out but relative to us.

Others, we feel we're incredibly well positioned we've got a sales force of 100 people.

Unknown Attendee: and more on the background. And then, any update on the status of the FDA inspection for DAXE manufacturing? Thank you.

We're going to be launching what our three products very innovative products and so we get leverage across all of these three product lines and we've got a very sort of targeted approach, where we're not trying to be everything to everybody and so we've already map that a lot of these early targets for US who have expressed interest in the differentiated products and if you look at just this this early.

Mark J. Foley: Great, Terence. Thanks for those questions. Maybe I'll take one and three and hand two over to Dustin.

Mark J. Foley: So first, on the fillers in the gross margin, I think that's getting into obviously ASPs and, you know, sort of cost of goods. I think it's a little early right now to get into the details of that. Once we sort of have the launch trajectory, we're in the market, you know, we'll be better positioned to be able to give, you know, metrics as we move forward. So, you know, just to remind you in terms of the nature of that relationship, it's a pure product transfer relationship where we acquire product from Teoxane for a set price. And then, based on what we sell it for, that'll ultimately determine our gross margin.

Preview clinical program with the our ha fillers, we've been very pleased even in this challenging environment with.

Sort of the volumes in these practices, how they've been receiving the product and how's that going so I mean, certainly if this continues into 2021 and it's in there is significant reduction in patient load. It would have an impact in terms of our plans relative to what our expectations were having said that because of our targeted approach are.

Small salesforce or just coming into the market, we're being very thoughtful and methodical with the rollout and we've got three product lines.

We're very confident that will be successful in the targeted manner in which we're going after and maybe a little bit of a relative basis, there could be an impact, but again, we feel very well position and since we don't have any revenue right now and if you look at our balance sheet, we're very well positioned I think to weather all this and so that when I hand, it to dust, maybe a little bit above.

Mark J. Foley: And then on the last one that you asked just about sort of the FDA, again, as we commented in our scripted comments, you know, right now, we're still very focused on our PDUFA date of November 25. There's, you know, been no change on that. It's sort of not company policy to talk about the specific details related to that, but we continue to march towards that date. And at this point, I don't have anything that would suggest that there's anything other than that date to move towards. With that, why don't I turn it over to Dustin for your question on the Salesforce and some of the questions you had there.

The comment on that the sampling approach absolutely. Thanks, Mark as you mentioned this is the first time accompanies been able to launch an entire range of products. All at once we've got our HIV two three and four so with that our sampling strategies really designed to instill confidence in the injector in the United States to deliver the outcomes that they want this pillar was designed with the pay.

Patient in mind, and so we're putting it in their hands to than utilize the experienced that the here verbally from the international positions, but then put it into their practice, we don't feel that the kind of the cobot environment today really changes our sampling strategy. We found that early and preview that the that those samples are utilized in a manner, which allows them to hone their skill sets and the feedback has been.

Dustin S. Sjuts: Yeah, thanks, Mark. As far as Salesforce goes, our strategy really was to select the kind of the best of the best as it relates to experience, but those that also can deliver in the environment that we're getting into, a competitive environment, those that can create a category, and also launch innovation. And those skill sets are variable as it relates to the different companies that they came from. We actually had more than 9,000 people apply to those 100 or so openings. We took that 9,000, broke it down to those that fit our profile and who we'd want to interview, interviewed a select group of those, and actually hired less than 5% of those that made it through that process. So we're very confident in the people that we've hired.

Excellent. So I believe that Thats really the strategy for the for the near term, yes, maybe David I'll just build on that because I think in your question and maybe making a leap here you are potentially sort of questioning whether or not we need to provide more samples in today's market because of the economic climate and.

We don't believe Thats. The case, if you look at the physicians that we're targeting we segmented the premium group and these are practices that are making decisions around product quality in the outcomes there.

And so while we certainly need to be mindful of thoughtful about our pricing there exists a market today that is very susceptible to sort of price changes in that will influence the ones that were calling on a very focused on patient outcomes and I think they're going to ultimately make a decision on up price product needs to be reasonably priced but if it's delivers more value.

And it's got the right properties, we expected that that will influence their decision more than whether or not we gave them an extra box of free product.

Okay Thats helpful. Thanks.

Thanks.

The Q. Our next question comes from the line of Biology puts us from Barclays. Your question. Please.

Dustin S. Sjuts: As it relates to experience, north of around 80% have aesthetic experience, with more than half of those coming from the injectable market. On the company specific level, there's a variety of organizational experiences that came from, so nothing one specific didn't stand out. All in all, all that leads us to believe that we have the best Salesforce and are very confident in our ability to deliver on the RHA collection launch, as well as with Hemp2MD.

Hi, good afternoon. Thanks for taking the questions couple of questions from me as you plan. Your I'll write your launch Im sure taught us a contingency planning visitor kind of go ahead Im hopefully come we don't come to that but could you explain how is the launch plans could change is that in such a situation.

And secondly could you also give us some update on what youre seeing on the ground onto the pent up demand floor.

Well furloughs and bell since thanks.

Well, thanks biologic great question, so on the contingency side of it.

We are doing all the things right now to be prepared to address whatever the environment is and as you're aware each state or each area is different and so I think you need to have different tools and techniques to make sure that you can engage physicians in whatever environment, they're comfortable engaging so we've got a variety of platform.

Dustin S. Sjuts: Does that answer your question?

Unknown Executive: Great. Thanks, Terence. Our next...

Unknown Attendee: The next question comes from the line of Stacy Ku from Kellen and Company. Your question, please.

Unknown Attendee: Hi, thanks for taking my questions and congratulations on the progress. So just the first question on the fillers: do they have the same kind of brand loyalty? How should we be thinking about the level of awareness of RH fillers among clinicians versus consumers? And I guess more so just trying to think about the pacing of the filler launch and then how it might relate to the doctor launch. Thanks.

Arms that we can deploy to make sure that we're educating.

And engaging our physician customers, whether thats completely virtual.

Whether theres different interactive modules or whether it's in person and so we've got all of that infrastructure in place.

And on the Crystal ball to know exactly what all the a variety of scenarios are that could play out here, but again I come back to my comments that I previously made that where we're just getting started we've got a relatively small salesforce compared to.

So many other players that are out there and we have three products and so we feel that we'll be able to target effectively the customers that are the right mix for us So our contingency planning as more how do we make sure that we're prepared to engage physicians and their local area in a manner that they're comfortable with and Thats compliant with whatever the guidelines are into.

Mark J. Foley: That's a great question. So, you know, this is the first introduction of the RHA filler line in the U.S., so there's really not much familiarity or awareness regarding the product, certainly not in the consumer market. Some physicians are aware of it because the RHA filler line has been available in Europe and some other markets outside of Europe for quite some time, and as physicians travel to international meetings, they hear about new products. But really, you know, we're creating the brand here in the U.S., and that's why we're taking a very disciplined approach to how we roll this out, how we introduce it. With any given geography, there's going to be some differences in terms of the look that they're going for or injection technique, and, you know, our collective experience, and certainly mine at Celtiq back in the Cool Sculpting days, is that you need to build a foundation of success, and that's what we're doing with this Preview Clinical Program, and so we'll work closely with the right physicians to build it, but we are going to need to build this brand here in the U.S. You know, in terms of how you look at the, you know, the daxubotulinum toxin A for injection and that launch strategy, it's going to mirror a lot what we're doing on the RHA filler side.

So what we're seeing on the ground we continue to be.

Encouraged by what we're hearing I think because of Q2 being largely shutdown quarter in many markets. We're definitely seeing a return of many patients out there we are seeing as we talked about before practices implementing new.

New protocols, and social distancing, which is maybe not allowing them to see quite as many patients in the same amount of time, but some are extending hours working Saturdays and what we are hearing is that some patients are engaging in more procedures to make up for last time. So we remain cautiously optimistic and we are definitely.

Hearing some encouraging signs from our physicians based on the patient interest that they're seeing.

Thanks, Mark just one more on.

Probably next steps now you'll seem to how the view how the best in class filler nine or 12 cents and also how does this have to payment processing system. Now is still left the dolphin billing moustache umbrella. The same question that I did last quarter. What's next are there any other aspirationally gaps or do you like to Phil.

Okay. Great question I mean, not at this point I think particularly in the facial aesthetics market. If we go back over time, certainly not having a pillar we thought potentially created a disadvantage for us.

Relative to just having a long acting neuromodulator, even though we thought we could be successful there and any other gap was just how are we going to provide a services offering to practice practices to address their desire for loyalty efficiencies more productivity and we think within Andy again, we got sort of a leapfrog solution. There. So we're very.

Mark J. Foley: You know, we're taking a very methodical approach where we start with the core group, we get them to experience the product, we use that engagement and feedback to inform some of the training and the targeting and the mapping that we're going to do, then we'll go into a phase launch and ultimately a broader launch, and that's really the same strategy that we'll ultimately take with our neuromodulator once approved.

Confident in the assets that we have in the facial aesthetic market and are very focused right now and execution I think the thing to note. Those you know we're entering a phase now were certainly we need to execute well in these set aside but with three data readouts in our therapeutics franchise I think that's going to start to become more front and center I think.

Anything that the cash position that we have right now gives us a lot of flexibility.

And certainly I think helps us.

To the extent that there are any challenges in the existing cobot market, where we continue to whether it and make sure that we can focus on driving long term value.

Unknown Executive: Thank you.

Perfect. Thanks, Mark Thank you.

Unknown Attendee: Thank you. Our next question comes from a line by David Amsellem from Piper Sandler. Your question, please.

Thank you. Our next question comes from the line of two Mucci from William Blair. Your question. Please.

Thanks for taking the questions.

Unknown Attendee: I have a question about sampling. I guess this is sort of a high-level question, just philosophically, how aggressive you intend to be regarding sampling for both the RHA fillers and also for DAXI, particularly in the context of this challenging macroeconomic environment and the lower office throughput that you cited, Mark. And then my second question is, you know, on this idea of reduced office throughput. I mean, is that something that you expect to be, you know, a headwind as we move through 2021? And, how worried should we be about it in the context of two new launches? Thanks.

On the therapeutic side with the one common November can you remind me how you manage capturing what's what's your score is through the dates when the set down will impacted.

And how many data points, maybe were impacted and.

Also how the baseline criteria and develop the patients that came in versus the expertise.

So great question, Tim I'm going to throw it over to all high to answer that.

So taking back you up question on the twist to score the good news for US was that.

On our patients were enrolled difficult, but for us for of CD, but this plus disclose actually is validated how do you do assessment and mostly so it came to assessing patients remotely we had almost no impact on mid had minimal impact on the quality of the observations that both the patients and physicians decisions were made.

Mark J. Foley: Yeah, so maybe I'll take the first part of that and then hand it over to Dustin to talk a little more specifically about the sampling side of it. So with regard to sort of the throughput and, you know, does that have any spillover into sort of the way we think about sampling? Of course, none of us has a crystal ball, and it's really difficult to know for sure exactly how this is going to play out.

Okay. So we believe that.

Overall quite a bit us standpoint, it had absolutely no impact on us EDI data.

Great and the baseline.

Was it wasnt similar to other trials EMEA.

Yes pretty much so I think that for the question. We have not had commented on the quality of patient data and have been assigned looks like so then to give you on the computer analysis and the fourth quarter, we will talk about how does the baseline compared to other trials.

Mark J. Foley: But relative to others, we feel we're incredibly well positioned. We've got a sales force of 100 people. We're going to be launching what are three very innovative products, and so we get leverage across all of these three product lines. And we've got a very sort of targeted approach where we're not trying to be everything to everybody. And so we've already mapped a lot of these early targets for us who have expressed interest in the differentiated products. And if you look at just this early preview clinical program with the RHA fillers, we've been very pleased, even in this challenging environment, with the volumes in these practices, how they've been receiving the product, and how that is going. So, I mean, certainly, if this continues into 2021 and there's a significant reduction in patient load, it would have an impact in terms of our plans relative to what our expectations were.

Okay understood for Juniper.

You Andrew.

Early holdings Q2 remind me again, you enrolled 83 patients, but how many wells next we intended to enroll you'd have a high dose logos.

Well that study and.

And maybe so we now just it's not the power or.

So it's more won't come true.

Yeah.

Right. So it's a good question, Tim So I think though the bottom line is that of and we plan to file a juniper. We had a forum study, which is a low dose medium dose high dose and a placebo arm and totaled up over 128 subjects and then type program.

When we did devaluation sometime in March and analyzed due to covered we stop the trial and then going about 73 patients at that time be we're confident that the program will eventually pickup optical goodwill of pass away, but we saw some light sometime in June and we started enrolling patients at on June postal timeframe.

Mark J. Foley: Having said that, because of our targeted approach, and our small sales force, we're just coming into the market. We're being very thoughtful and methodical with the rollout, and we've got three product lines. We're very confident that we'll be successful in the targeted manner in which we're going after it, and maybe on a little bit of a relative basis there could be an impact. But, again, we feel very well positioned, and since we don't have any revenue right now, and if you look at our balance sheet, we're very well positioned, I think, to weather all of this. And so with that, why don't I hand it to Dustin to make a little bit of a comment on the sampling approach?

And then we realized that given the soldiers in different bundle the country and we talked about that in our press release. It was a pragmatic on our part to make sure that how do we tried to optimize our title and get the data at an optimal timeframe. So.

So about two thirds of the patient enrolled.

And you could look at the overall quality updated analysis, what we realized that it has almost minimal impact on the powering of the study lumpy was seized that we'll have sufficient number of patients in each arm, but give us good confidence as to what dose to pick two advantage program into phase three that is our goal right now.

Great. Thanks for all the clarity.

Dustin S. Sjuts: Absolutely. Thanks, Mark.

Thank you aren't next question comes from the line of surgical into from Needham and company. Your question. Please.

Dustin S. Sjuts: As you mentioned, this is the first time a company's been able to launch an entire range of products all at once. We've got RHA 2, 3, and 4. So with that, our sampling strategy is really designed to instill confidence in the injector in the United States to deliver the outcomes that they want. This filler was designed with the patient in mind, and so we're putting it in their hands to then utilize the experience that they hear verbally from the international physicians but then put it into their practice. We don't feel that the kind of COVID environment today really changes our sampling strategy. We found early in preview that the samples are utilized in a manner which allows them to hone their skill sets, and the feedback has been excellent. So I believe that that's really their strategy for the near term.

Hey, Good afternoon, guys. This is 10 officers I just said a few questions first on the hints MD.

In terms of the metrics can you just generally describe what types of metrics that you plan to provide in the coming quarters. For example in a number of subscription by the physicians want to patients or even the number of payments when transactions. So any details there would be great and then just moving on to.

Moving to taxi.

How do you had any label discussions with FDA so far.

And then do you expect.

I guess a late cycle meeting.

To be also had with the FDA. Thank you.

So great questions I'll take the last two first so in terms of the the doxey label and late cycle meeting again, its company policy not to comment on the specifics around the engagement with the agency. However, as we did say in our scripted remarks, we continue to March towards in November Twentyth of PDUFA date.

Mark J. Foley: David, I'll just build on that because, in your question, and maybe I'm making a leap here, you're potentially sort of questioning whether or not we need to provide more samples in today's market because of the economic climate. We don't believe that's the case.

And so right now we're very focused on on that date and.

Hopefully approval.

As it relates to the hit MD side of it on the data points again, we're still early when we announced the hidden deal and the rationale we talked about and being in roughly 175 accounts 2019. The generated 1.4 million in revenue had sort of three buckets of revenue to had sort of partnership revenue.

Mark J. Foley: If you look at the physicians that we're targeting, we've segmented the premium group, and these are practices that are making decisions around product quality and outcomes there. And so while we certainly need to be mindful and thoughtful about our pricing, there exists a market today that is very susceptible to price changes, and that will influence. The ones that we're calling on are very focused on patient outcomes, and I think they're going to ultimately make a decision on whether a product needs to be reasonably priced, but if it delivers more value and it's got the right properties, we expect that that will influence their decision more than whether or not we gave them an extra box of free product.

Subscription revenue and they had platform revenue, which was really driven by credit card processing.

As we roll this out in conjunction with the Rhj product in through the commercial Salesforce that we've put together.

We want to get into the market get some of the feedback in the traction there before we come back and start putting data points out there. We got that there is interest in the investor community is sort of understand how to measure the success of this and as we have more competence and sort of that slope in that runway, we'll certainly share it.

Got it thank you.

Q.

Thank you. Our next question comes from the line to occur shallow Patel from Guggenheim. Your question. Please.

Thanks, so much for taking the questions just on for Seamus here.

Unknown Attendee: Okay, that's helpful. Thanks.

Unknown Executive: Thank you.

Unknown Attendee: Thank you. Our next question comes from the line of Balaji Prasad from Barclays. Your question, please.

So a couple on the therapeutic option and then maybe one on just the previewed program.

For the pillars so.

Unknown Attendee: Hi, good afternoon. Thanks for the questions. There are a couple of questions for me.

Thanks for the cervical dystonia Aston trial, just for the Paul timeline presume that by November and but.

Unknown Attendee: As you plan your RHI launch, I'm sure you've thought of a contingency plan if there's a recurrence of COVID, and hopefully, we don't come to that. But could you explain how the launch plans could change if that happens in such a situation? And secondly, could you also give us some update on what you're seeing on the ground with regard to the pent up demand for fillers and toxins? Thanks.

The wrong. This is just clarifying that and then for juniper.

I think there was additional color there, but basically yes understanding that caused you to co bid.

Yes, it was expected to readout in the first half and obviously you just optimizing trial there for shooting for lower patient.

Patients there so maybe just why the 120 patients.

Initially and then.

Without power being impacted with recruiting.

Mark J. Foley: Yeah, well, thanks, Balaji. A great question. So on the contingency side of it, we're doing all the things right now to be prepared to address whatever the environment is. And, as you know, each state or each area is different. And so I think you need to have different tools and techniques to make sure that you can engage physicians in whatever environment they're comfortable engaging. So we've got a variety of platforms that we can deploy to make sure that we're educating and engaging our physician customers, whether that's completely virtual, whether there's different interactive modules, or whether it's in person. And so we've got all of that infrastructure in place. You know, it's hard to see into the crystal ball to know exactly what all the variety of scenarios are that could play out here. But again, I come back to my comments that I previously made that, you know, we're just getting started; we've got a relatively small sales force compared to, you know, many other players that are out there. And we have three products.

Fewer patients.

And then also just with timelines leading up to the phase three start just how could that be occurring earlier, just hoping that had some color in trying to understand timelines there.

Then lastly for for the Thermo Phil is just any color on terms of physician targeting or potential read theres for the for the pull through for the full launch on I believe heard 100000 and sales there. So just maybe pricing or maybe how many units were sold.

I really appreciate it thanks.

Sure. So I'll try make sure we capture all leaves and maybe I'll start on therapeutic in and handed over to.

Yeah on the Juniper question, but on the CD side. It yet we've tightened that range up we've talked a little bit about it previously being a second half and now we're seeing fall. So we're taking that range up and.

We're getting closer is I also mentioned that we're fortunate in that we fully rolled the patients in the trouble Porco would hit so that program continues on track and we'll be able to.

Report that out.

And then before I hand, it over to him on that on the Juniper side, you asked a little bit about sort of the phase three and timing I think we'll capture all of that as part of our 2021 planning cycle. When we kind of communicate out what sort of our spending priorities will be for 2021. Obviously this year, we had a lot of different clinical programs going on I think getting these days.

Mark J. Foley: And so, you know, we feel that we'll be able to target effectively the customers that are the right mix for us. So our contingency planning is more how do we make sure that we're prepared to engage physicians in their local area in a manner that they're comfortable with, and that's compliant with whatever the guidelines are. In terms of what we're seeing on the ground, we continue to be encouraged by what we're hearing. I think because of Q2 being largely a shutdown quarter in many markets, we are definitely seeing a return of many patients out there. We are seeing, as we talked about before, practices implementing new protocols and social distancing, which is, you know, maybe not allowing them to see quite as many patients in the same amount of time, but some are extending hours and working on Saturdays.

Data readouts in the different therapeutic side of it is going to help inform sort of the priorities in the investments that we make next year and so we'll be sharing that as part of our 2021 side of it are you want to come a little bit more on the question around sort of Juniper why were if we were targeting a larger number and our 80 something that we continue to feel thats powered showed it was a good question. So.

Hi, Juniper, I think I'm going to just emphasize what I said earlier on which is that we pause to deployment.

End of a new bus to do closely as we also mentioned we also started the program back in June on June 1st and then we realized that because of so it's less challenging for us to really predict what time and how long ago take for us to actually enrolled 120 patients. So at that point, we restarted on file.

Mark J. Foley: Thanks, Mark. And just one more on the probably next steps now. You seem to have the best-in-class filler, Neurotoxin, and you've also added a disruptive payment processing system. Now we're still left with half a billion in cash. And I'll ask the same question that I did last quarter. What next? Are there any other aspirational gaps that you'd like to fill?

And we've been able to general about 10 additional patients will go to up 83.

Question is died when we had hundred 20 admissions before which about type two patients but group versus 80 patients now that gives you about 20 patients but group.

We realized that in this particular situation the have sufficient power I would say sufficient information that you can obtain so that because it is a phase two program. We can at least be able to choose which put it low dose will be beneficial for patients to go into the phase three program.

Mark J. Foley: Yeah, great question. I mean, not at this point.

Mark J. Foley: I think particularly in the facial aesthetics market, you know, if we go back over time, certainly not having a filler we thought potentially created a disadvantage for us relative to just having a long-acting neuromodulator, even though we thought we could be successful there. And then the other gap was just, you know, how are we going to provide a services offering to practices to address their desire for loyalty, efficiency, and more productivity? And we think, you know, within MD, again, we have sort of a leapfrog solution there. So we're very confident in the assets that we have in the facial aesthetic market and, you know, are very focused right now on execution. I think the thing to note, though, is that we're entering a phase now where certainly we need to execute well on the aesthetic side, but with, you know, three data readouts in our therapeutics franchise, I think that that's going to start to become more front and center. I think, if anything, that the cash position that we have right now gives us a lot of flexibility and certainly, I think, helps us to the extent that there are any challenges in the existing COVID market, where we continue to weather them and make sure that we can focus on driving long-term value.

So because the phase two program was not powered for any.

Pivotal trials to make a decision for filing we did have an opportunity here to make sure that we can pick a dose.

Advance into the phase three program from a trial.

Having done that in terms of timelines, we believe that we'd be able to get our topline data sometime in early part of next year.

And then after that on we would decide you know after our next David Ft, and meeting with the standard Endo phase two meetings and tie and we want to divulge more information about what the plan would be photo phase two programs and in on.

Great.

And then your question about sort of the preview program dermal fillers and pricing I, just I'll make one comment I'll hand, it to dust and on that.

Revenue that we announced in the quarter as we stated in our prepared remarks. This is really about making sure that our systems were ready and so with great that we were able to bring product supply in from T. Roxane make sure that we pressure tested our commercial systems, we could pull it through we could ship it.

To our distributor Thats handling the product for us get it into the hands of customers and so we were able to pressure test all those systems and that revenue reflected kind of the successful accomplishment of that and so with less about trying to drive any real revenue, but make sure that we were ready to go once we launch in September and so maybe I'll hand, it over to dust and talk a little bit about preview dermal fillers.

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

Unknown Executive: Thank you.

Unknown Attendee: Thank you. Our next question comes from the line of Tim Lucci from William Blair. Your question, please.

Unknown Attendee: Thanks for taking my questions. On the therapeutic side, with Aspen 1 coming in November, can you remind me how you managed capturing the Twister scores during the dates when the shutdown was impacted? And you know how many data points maybe were impacted and, Also, how the baseline criteria ended up in the patients that came in versus expectations?

As pricing absolutely. Thank mark so as relates to preview our targeting exercise for preview is really in line with our overall market targeting strategy and that is we're looking to create the prestige categories. These physicians are focused on delivering outcomes and orient that above driving value on price.

And so with that we chose those physicians that are influencing on the podium really understand the technology today with our AJ. It's a first technology be launched since 2008 that got experience with that product now getting comfortable and helping us Orient our launch plans as we broaden that out. We'll then take that same prestige categories segmentation and.

Unknown Executive: So, great question. Tim, I'm going to throw that over to Abhay to answer that.

Unknown Executive: Right, so taking back to your question on the Twister score, the good news for us was that all our patients were enrolled before COVID for CD, but this Twister score actually validated how you do assessments remotely. So when it came to assessing patients remotely, we had almost no impact or minimal impact on the quality of the observations that both the patients and the physicians were making. So we believe that from an overall quality of data standpoint, it had absolutely no impact on our CD data.

Build that to the marketplace of the physicians.

When it comes to pricing.

Strategy on pricing has been clear we believe the innovation warrants a premium we will likely be launching our ha with a slight premium to the consumer side, ensuring that the margins for the physicians maintain and are focused on growing in the dermal fillers space as far as specifics for pricing for competitive reasons, we will go into the specific pricing at this.

Unknown Executive: Great. And the baseline, was it, you know, similar to other trials in space?

Time.

Thank you.

Our next question comes more in of Douglas Tsao from.

Unknown Executive: Yeah pretty much so, I think you know that was a question we have not yet commented on the quality of patient data and how the baseline looks like. When we give you all the complete analysis in the fourth quarter, we will talk about how the baseline compares to other trials.

Wainwright your question please.

Hi, Thanks for taking my question. This is Chris the almost on the line for Doug.

I just wanted to understand a little bit more about in them.

Have you had the interaction with allergan regarding their intent to remain or exit the platform.

Unknown Executive: Okay, understood. And for Juniper, you know, you ended a little early.

And I also want to learn a little bit more about do you have a sense about the capacity of the.

Unknown Attendee: To remind me again, you enrolled 83 patients, but how many were initially intended to enroll? Do you have a high-dose, low-dose arm for that study? And maybe, you know, should we now just expect it not to be powered for efficacy, you know, to show efficacy, it's just more of a kind of true phase two now?

Practices are open have any of them been affected by the resurgence in our Cobra cases. Thanks.

Great questions.

So first on the hit MD platform side of it.

Just for context previously allergy and had entered into a partnership with hit MD too.

Unknown Executive: Yeah, right. So it's a great question, Tim.

Integrate their brilliant distinctions patient loyalty program into it.

Unknown Executive: So I think the bottom line is that when we planned the trial for Juniper, we had a four-arm study, which is a low-dose, medium-dose, high-dose, and a placebo arm and totaled up about 128 subjects in the entire program. But when we did the evaluation sometime in March, we realized that due to COVID, we stopped the trial, and we enrolled about 73 patients. At that time, we were confident that the program would eventually pick up after COVID passed away. But we saw some light sometime in June, and we started re-enrolling patients around June 1st. And then we realized that given the surges in different parts of the country, and we talked about that in our press release, it was a pragmatic call on our part to make sure that we try to optimize our trial and get the data at an optimal time frame.

Since we've acquired them.

Our overall focus is it little bit different it's to make it an open platform. So that all partners that want to participate on it all brands can.

We have heard from Allergan that at this point, they're going to pull back and not continue to move forward with the partnership with an MD.

Which when we did our sort of deal assessment in model, we sort of took that into consideration and frankly, if you look at the value of the platform the real value to us in in the model comes down to sort of payment processing subscription services and then a host of brand partnerships. So we will continue to keep it as an open platform for those that brands that want to participate.

It on it but for US, we really think that the values going to lie in the payment processing subscriptions and then the ability for us to create our own kind of white label loyalty program that puts the physician front and center.

In terms of the capacity at the practices and what we're hearing out there again its its wide ranging you know with each market sort of being its own situation right. You've got some that have certainly pulled back in and have become a little bit more conservative after opening up if something we continue to operate as though they are unaffected I do think that universally what we.

Unknown Executive: So about two-thirds of the patients were enrolled. And if you look at the overall quality of the data analysis, we found that it had almost minimal impact on the powering of the study. What we will see is that we'll have a sufficient number of patients at each arm to give us good confidence as to what dose to pick to advance this program into phase three. That is our goal.

I have heard for those that did shut down for a period of time is that there was no doubt there was a large pent up demand and then thats sort of now coming back to a little bit more normal and we did hear that patients are anxious to spend perhaps a little bit more money and do more procedures. Just because there is sort of pent up demand and theyre now maybe a variety of things that they want to get done that.

Whereas in the past it would have just come in for one thing.

Unknown Executive: Great, thanks for all the clarity. Thank you.

So it's still I think to be seen what happens in the back half of the air but certainly through the preview program on the number practices that we're engaging with on a regular basis.

Unknown Attendee: Next question comes in the line of Serge Belanger from Needham & Company. Your question, please.

People are definitely doing cases, and there's a lot of interest out there and there's a lot of consumers frankly, who are home and who are off vacationing are doing other things that they might this time of year that are also looking at having a set of treatments performed.

Unknown Attendee: Hey, good afternoon, guys. This is Tien Ong for SEARCH.

Unknown Attendee: I just had a few questions. First, on HintMD, in terms of the metrics, can you just generally describe what types of metrics that you plan to provide in the coming quarters? For example, you know, the number of subscriptions by physicians or patients or even the number of payments or transactions. So, any details there would be great. And then, just moving on to DAXI, have you had any label discussions with the FDA so far? And then, do you expect, I guess, a late cycle meeting to also be held with the FDA? Thank you.

Awesome. Thank you so much great. Thank you.

Thank you. This does conclude the question and answer session of today's program I'd like to and the program back to Mark Foley for any further remarks.

Thank you operator in September we plan to virtually attend the Wells Fargo Morgan Stanley and Cantor healthcare conferences, we welcome your request for meetings at these events indirectly through us.

Feel free to reach out to Genie, if you'd like to schedule some time.

And with that I would like to thank you offer participating in today's call.

Thank you ladies and gentlemen few participation in today's conference. This does conclude the program you may now disconnect good day.

Unknown Executive: So, great questions. I'll take the last two first.

Mark J. Foley: So, in terms of the, you know, DAXI label and late cycle meeting, again, it's company policy not to comment on the specifics around the engagement with the agency. However, as we did say in our scripted remarks, you know, we continue to march towards the November 25th PDUFA date. And so, you know, right now, we're very focused on that date and, you know, hopefully, approval.

[music].

Mark J. Foley: As it relates to the HIN-MD side of it on the data points, again, we're still early. You know, when we announced the HIN-MD deal and the rationale, we talked about them being in roughly 175 accounts. In 2019, they generated $1.4 million in revenue. They had sort of three buckets of revenue. They had sort of partnership revenue, they had subscription revenue, and they had platform revenue, which was really driven by credit card processing. You know, as we roll this out in conjunction with the RHA product and through the commercial sales force that we've put together, we want to get into the market, get some of the feedback and the traction there before we come back and start putting data points out there. We understand that there's an interest in the investor community to sort of understand how to, you know, measure the success of this. And as we have more confidence in sort of that slope and that runway, we'll certainly share it.

Unknown Attendee: Got it. Thank you.

Unknown Attendee: Thank you. Our next question comes from the line of Kushal Patel from Guggenheim. Your question, please.

Unknown Attendee: So, a couple on the therapeutic opportunity, then maybe one on just the preview program for the fillers. So I think for the cervical dystonia Aspen trial, just, you know, for the full timeline, presume that by November end. But to be wrong there, so just clarifying that. And then for Juniper, I think, you know, there was additional color there.

Unknown Attendee: But basically, yeah, understanding that it was paused due to COVID. You know, it was expected to read out in the first half and obviously just optimizing the trial there for shooting for lower patient patients there. So maybe just why 128 patients initially and then, you know, without power being impacted by recruiting fewer patients. And then also, just with timelines leading up to the phase three start, just how could that be occurring earlier? Just hoping to have some color in trying to understand timelines there. And then lastly, for the dermal fillers, any color on terms of physician targeting or, you know, potential read throughs for the pull through for the full launch. You know, I believe I heard one hundred thousand in sales there. So, just maybe pricing or maybe how many units were sold. I really appreciate it. Thanks.

[music].

Unknown Executive: Sure. So I'll try to make sure we capture all these.

Mark J. Foley: And maybe I'll start on the therapeutic and then hand it over to Abhay on the Juniper question. But, you know, on the CD side, yeah, we've tightened that range up. We talked a little bit about it previously being a second half, and now we're saying fall. So we're tightening that range up.

Mark J. Foley: And, you know, we're getting closer, as Abhay also mentioned, that we're fortunate in that we'd fully enrolled the patients in the trial before COVID hit. So that program continues on track, and we'll be able to, you know, report that out. And then before I hand it over to him on the Juniper side, you know, you asked a little bit about sort of phase three and timing. I think we'll capture all of that as part of our 2021 planning cycle when we kind of communicate out what sort of our spend and priorities will be for 2021. Obviously, this year, we had a lot of different clinical programs going on. I think getting these data readouts and the different therapeutic sides of it is going to help inform sort of the priorities and the investments that we make next year. And so, you know, we'll be sharing that as part of our 2021 side of it. Abhay, do you want to comment a little bit more on the question around sort of Juniper and why we're, if we were targeting a larger number, now we're at 80-something, that we continue to feel that that's good?

Abhay Joshi: Thank you. So for Juniper, I think I'm going to just reemphasize what I said earlier on, which is that we paused due to COVID. And when we pause due to COVID, as we also mentioned, we also started the program back in June, on June 1. And then we realized that because of surge, it was challenging for us to really predict what time and how long it would take for us to actually enroll all 128 patients. So at that point, we restarted our trial, and we were able to enroll about 10 additional patients, so a total of 83. Now the question is that when we had 128 patients before, which was about 32 patients per group, versus 83 patients now, that gives you about 20 patients per group, we realized that in this particular situation, we have sufficient power, I would say sufficient information that we can obtain so that, because it's a phase two program, we can at least be able to choose which particular dose will be beneficial for patients to go into the phase three program.

Abhay Joshi: So because the phase two program was not powered for any pivotal trials to make a decision about filing, we did have an opportunity here to make sure that we can pick a dose and advance into the phase three program for our trial. Having done that, in terms of timelines, we believe that we'll be able to get our top-line data sometime in the early part of next year. And then after that, we will decide, you know, after our next stage of the FDA meeting with the standard end of Phase II meetings and trials. We will divulge more information about what the plan would be for our Phase III programs later on.

Abhay Joshi: And then your question about sort of the preview program, dermal fillers, and pricing, I just, I'll make one comment and I'll hand it to Dustin on that. You know, the revenue that we announced in the quarter, as we stated in our prepared remarks, was really about making sure that our systems were ready. And so it was great that we were able to bring product supply in from Teoxane, make sure that we pressure tested our commercial systems, we could pull it through, we could, you know, ship it to our distributor that's handling the product for us, get it into the hands of customers, and so we were able to pressure test all those systems, and that revenue reflected kind of the successful accomplishment of that. And so it was less about trying to And so maybe I'll hand it over to Dustin to talk a little bit about preview dermal fillers pricing.

Mark J. Foley: Absolutely. Thanks, Mark. So, as it relates to Preview, our targeting exercise for Preview is really in line with our overall market targeting strategy, and that is, we're looking to create the prestige category. These physicians are focused on delivering outcomes and focusing that above driving value on price. And so with that, we chose those physicians that are influencing, on the podium, really understand the technology today. You know, with RHA, it's the first technology to be launched since 2008. They have experience with that product, and now are getting comfortable and helping us orient our launch plans. As we broaden that out, we'll then take that same prestige category segmentation and build that into the marketplace of the physician. When it comes to pricing, you know, our strategy on pricing has been clear. We believe that innovation warrants a premium. We will likely be launching RHA with a slight premium on the consumer side and ensuring that the margins for the physicians maintain and are focused on growing in the dermal filler space. As far as specifics for pricing, you know, for competitive reasons, we won't go into the specific pricing at this time.

[music].

Dustin S. Sjuts: Thank you. Our next question comes from the line of Douglas Tsao from H.C. Wainwright. Your question, please.

Unknown Attendee: Hi, thanks for taking my question. This is Chris Bialas on the line for Doug.

Unknown Attendee: I just wanted to understand a little bit more about HintMD. Have you had any interaction with allergens regarding their intent to remain or exit the platform? And I also want to learn a little bit more about how much the practices are open. Have any of them been affected by the resurgence in COVID cases?

Mark J. Foley: Thanks.

Mark J. Foley: Great questions. So first, on the HIN-MD platform side of it, you know, just for context, Allergan had entered into a partnership with HIN-MD to integrate their Brilliant Distinctions Patient Loyalty Program into it. You know, since we acquired them, our overall focus is a little bit different. It's to make it an open platform so that all partners that want to participate in it, all brands can. We have heard from Allergan that at this point, they're going to pull back and not continue to move forward with the partnership with HIN-MD, which when we did our sort of deal assessment and model, we sort of took that into consideration. And frankly, if you look at the value of the platform, the real value to us in the model comes down to sort of payment processing, subscription services, and then a host of brand partnerships. So we will continue to keep it as an open platform for those brands that want to participate in it. But for us, we really think that the value is going to lie in the payment processing, subscriptions, and then the ability for us to create our own kind of white-label loyalty program that puts the brand front and center.

Mark J. Foley: In terms of the capacity of the practices and what we're hearing out there, again, it's wide ranging, you know, with each market sort of being its own situation, right? You've got some that have certainly pulled back in and have become a little bit more conservative after opening up. You have some who continue to operate as though they're unaffected. I do think that, universally, what we have heard for those that did shut down for a period of time is that there was no doubt there was a large pent-up demand. And then that's sort of now coming back to a little bit more normal. And we did hear that, you know, patients are anxious to spend perhaps a little bit more money and do more procedures just because there's sort of pent-up demand and there now may be a variety of things that they want to get done, whereas in the past, they would have just come in for one thing.

Mark J. Foley: So it's still, I think, you know, to be seen what happens in the second half of the year. But certainly, through the preview program and the number of practices that we're engaging with on a regular basis, you know, people are definitely doing cases, and there's a lot of interest out there. And, you know, there are a lot of consumers, frankly, who are home and who aren't off, you know, vacationing or doing other things that they might do this time of year that are also looking at having aesthetic treatments performed.

Unknown Attendee: Awesome. Thank you so much.

[music].

Unknown Executive: Great, thank you.

Operator: Thank you. This does conclude the question and answer session for today's program. I'd like to hand the program back to Mark Foley for any further questions.

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

Operator: In September, we plan to virtually attend the Wells Fargo, Morgan Stanley, and Canter Healthcare Conferences. We welcome your requests for meetings at these events and directly through us. Feel free to reach out to Jeanne if you'd like to schedule some time. And with that, I would like to thank you all for participating in today's call.

Unknown Executive: Thank you, ladies and gentlemen, for your participation in today's conference. This does conclude the program. You may now disconnect. Good day.

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