Welcome to the Revance Therapeutics Second Quarter 2022 Financial Results and Corporate Update Conference Call. [Operator Instructions] As a reminder, this call is being recorded today, Tuesday, August 9, 2022. I would now like to turn the conference call over to Jessica Serra, Head of Investor Relations and ESG for Revance. Please go ahead.

Thank you, Bella. Joining us on the call today from Revance, are Chief Executive Officer, Mark Foley; President, Dustin Sjuts; and Chief Financial Officer, Toby Schilke. During this conference call, management will make forward-looking statements, including statements related to the regulatory process and potential approval for DaxibotulinumtoxinA for Injection [ph] in glabellar lines and in therapeutic indication, potential indications for RHA Redensity to the fact of RHA questions and open platform, consumer preferences, the benefits to us, practices and patients of our products and services, our financial performance, 2022 guidance, expected cash runway, strategic priorities and capital allocation plans, our market and revenue opportunity, our potential growth and our business strategy, planned operations and commercialization plans. Our actual results and the timeliness could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. Factors that could cause results to be different from these statements include factors the company describes in the section titled Risk Factors in our quarterly report on Form 10-Q filed with the SEC today, August 9, 2022. Revance undertakes no duty or obligation to update any forward-looking statements as a result of new information, future events or changes in its expectations. With that, I will turn the call over to Mark Foley, Chief Executive Officer of Revance. Mark?

Thank you, Jessica. Good afternoon, everyone and thank you for joining our second quarter 2022 financial results conference call. We’re very pleased with our performance in the second quarter, highlighted by our best RHA quarter-to-date and solid account growth across our fillers and OPUL relational commerce platform. These results reflect the continued success of our launch and also the strength and resilience of the facial injectables market. We also decided to announce the launch of RHA Redensity, the first and only FDA-approved dermal filler for dynamic perioral for lip lines. Redensity is the latest innovation to our RHA Collection which now includes 4 distinct pillars that meets a broad range of consumer and practice needs. As a result of the progress we’ve made in the first half of the year, including the re-submission and acceptance of our BLA DaxibotulinumtoxinA injection and our strong commercial traction, we look forward to our September 8 PDUFA date and the prospect of entering the new growth pace. As a reminder, the FDA designated our BLA as a Class II resubmission which has a 6-month review period and includes a required re-inspection of our manufacturing facility. As we previously communicated, we did not intend to provide details regarding our ongoing interactions with the agency. However, it might have the information we received this morning regarding the likelihood that the agency could satisfy portfolio requests on our manufacturing inspection. Prior to our PDUFA date, we would like to provide everyone with a regulatory update, so that all investors have access to the same information. First, I am pleased to report that the FDA completed their inspection of our manufacturing facility from July 11th to July 15th. Next, the corrective and preventive actions completed in response to the 5 observations from the previous Form 483 that we received in July 2021 related to our preapproval inspection, have been reviewed by the FDA and are considered closed. Lastly, as the conclusion of the reinspection of our manufacturing facility in July, the agency provided us with The Form 483, that included 3 observations. For transparency and reference, we’ve included a summary of the observations in our earnings press release in Form 10-Q. A couple of points I would like to make about the 3 observations on Form 483 we received on July 15th, 2022. First, it does not include any of the 5 observations that were outstanding from our previous Form 483 related to our pre-approval inspection. You’ll recall that these observations were the focus of our resubmission and as previously stated are considered close. Second, we are confident in our responses which we have already provided to the FDA and I’m proud of our team for the timely turnaround. We continue to expect a decision from the agency by our PDUFA date of September 8th which is just one month away. Obtaining approval remains our top corporate priority for 2022 and our team is prepared and eager to launch our flagship drug product once approved. As a reminder on approval, we will have the opportunity to expand our access to the $3.2 billion U.S. facial injectables market which according to the latest Decision Resources Group report includes neuromodulator sales of $1.7 billion and dermal filler sales of $1.5 billion. Further, according to the American Society of Plastic Surgeons, neuromodulators and dermal fillers remain the top 2 most performed minimally invasive aesthetic procedures. Historically, the market has grown in high-single to low double-digits and has held up well against macroeconomic headwinds, such as the economic recession in 2008 to 2009. Even with the COVID pandemic in 2020, we saw a B-shaped recovery in the following year when practices reopened. Over the mid to long term, the U.S. market is expected to grow at a compound annual growth rate of 8% to $4.7 billion by 2026. Given the current economic environment and questions surrounding its potential impact on facial injectables market, I’d like to make a few comments. Today, based on the accounts that we are calling on, we haven’t seen an impact on activity that would be beyond typical seasonality trends. You’ll recall that the second and fourth quarters are usually the busiest times of the year for procedures compared to the first and third quarters. However, should macroeconomic factors begin to impact consumer spending in our target accounts, we take comfort in the resilience of the facial injectables market prior downturns and more importantly, our unique re-positioned in the market versus other manufacturers. First, we are still in our launch phase with RHA Collection. Second, we are bringing new innovations to the market, including today’s launch of RHA Redensity and the launch of our next-generation neuromodulator approved. And third, we have a differentiated go-to-market strategy that is focused on the prestige segment. Now let me turn to therapeutics. The approval of DaxibotulinumtoxinA for Injection for glabellar lines will allow us to unlock opportunity in muscle movement disorders. We have a strong pipeline in this category with our completed Phase 3 program for cervical dystonia and our completed Phase 2 program for upper limb spasticity. The clinical data in both of these programs demonstrated DaxibotulinumtoxinA for Injection efficacy and median duration of effect of up to 24 weeks. We will be ready to file supplemental BLA for cervical dystonia shortly after the FDA’s approval of our long-acting neuromodulator in glabellar lines. As a reminder, cervical dystonia would be our entry point into the over $900 million U.S. muscle movement disorder category that is expected to grow to $1.4 billion in the U.S. by 2026. In summary, we feel very good about the growth of our base business, our expanding RHA Collection and our pipeline in aesthetics and therapeutics, pending approval of DaxibotulinumtoxinA for Injection for glabellar lines. With that, I’ll turn the call over to Dustin, who will cover our performance in the second quarter. Dustin?

Thank you, Mark. We're very proud and have delivered our best quarter of RHA sales in Q2 totaling $25.5 million, a 50% increase year-over-year. This brings our first half 2022 RHA sales, $46.3 million and cumulative sales since launch over $130 million. These are solid results, independent of neuromodulator telling us that RHA the product that stands on its own. During the second quarter, we saw healthy demand and productivity across our accounts. Awareness and adoption continue to be driven by our targeted sales and marketing initiatives, world-class training and education programs and most importantly, high injector and consumer satisfaction. At the quarter end, we have over 4,000 accounts across our portfolio representing a strong base of practice partners all anticipating a PDUFA date of September 8th for DaxibotulinumtoxinA for Injection. We are also excited to continue to bring new innovation to market with the launch of our RHA Redensity. Redensity was approved by the FDA to a partner Teoxane SA and is the first and only FDA-approved dermal filler for both superficial dermal and dermal injection of perioral rhytids or lip line. It has the most stretch compared to RHA 2, RHA 3 and RHA 4 and a shallow of injection depth, allowing it to adapt to the highly dynamic moving areas of the lip. With Redensity, injectors can softer or fine tune the appearance of lip line, a challenging area to treat prior to the introduction of Redensity. And like the rest of the RHA Collection, the product is designed to closely resemble the natural HA found in the skin, results look natural and can last through 12 months. Presenting now in the market, we have 4 dynamic formulations of fillers offer a wide range of injection depths across the continuum of consumer needs. RHA Redensity for fine tuning lips, RHA 2 for softening facial lines, RHA 3 for refined smoothing of wrinkles and folds and RHA 4 for natural volume for severe folds, deeper deficits. In fact, we are the only company to have introduced 4 fillers to market within 2 years. Consistent with the launch of RHA 2, RHA 3 and RHA 4, we complete the preview, our early training and education program with practice partners and we're very encouraged by the positive feedback we've received. Injectors said Redensity is different than anything they have had on their shelves. It's easy to inject and its ability to correct very fine lines around the mouth, fills the wait in existing products. They believe the product is essential and excited to have Redensity complement filler line. Consumer feedback has also been very positive and love the smooth and natural look with Redensity. RHA Redensity is also currently being evaluated in a clinical trial by our partner Teoxane SA for the correction of infraorbital hollows or tear troughs. This is another delicate area of the face and is challenging to treat and we're excited about the prospects of a potential label expansion of RHA Redensity. Turning to OPUL. We continue to make progress in driving adoption and building membership capabilities during the second quarter. Gross processing volume or GPV for Q2 was $166 million, up 23.2% year-over-year. On a trailing 12-month basis, GPV totalled over $600 million at the end of Q2. As a reminder, we believe GPV is an important indicator of our future revenue potential in the U.S. aesthetics payment processing market and opportunity to exceed $0.5 billion per year. We will continue to focus on new features and account growth for OPUL, it not only deepens our relationships with our practice partners but also unlock additional revenue potential for Revance. In summary, we feel really good about how our aesthetics portfolio is poised for additional growth. Particularly with the addition of DaxibotulinumtoxinA for Injection in glabellar line if approved. Our attention is focused on our September 8th PDUFA date. We are very much looking forward to introducing a differentiated performance profile of our next generation neuromodulator to the U.S. aesthetic market. Consistent with our approach to the launch of the RHA Collection, the commercial launch of DaxibotulinumtoxinA for Injection will be preceded by our preview program with lead practice partners. Finally, recently participated in the 2022 TOXINS International Conference, we presented data on DaxibotulinumtoxinA for Injection that includes new data demonstrating the unique properties of our novel excipient peptide. Our poster showcase how the -- positively charged excipient peptide combined directly to the core neurotoxin and can enhance the binding of the neurotoxin to cell [ph]. The new data underscore DaxibotulinumtoxinA for Injection, innovative formulation and our commitment to the advancement of research of neurotoxin in both aesthetics and therapeutic indications. With that, I will turn the call over to Toby to cover our second quarter financials.

Thank you, Dustin. Total revenue for the second quarter of 2022 increased 51% from the same period in 2021 to $28.4 million, primarily driven by increased sales of the RHA Collection. Revenue for the second quarter included $25.5 million of product revenue, $1.7 million of collaboration revenue and $1.2 million of service revenue. Turning to operating expenses. We continue to execute on our corporate priority of disciplined cash, capital allocation in addition to our ongoing cash preservation measures. GAAP operating expenses for the second quarter were $86.2 million compared to $89.1 million for the same period last year. Excluding depreciation, amortization and stock-based compensation, our non-GAAP operating expenses were $62.0 million, an 8% decline over the same period last year due to lower SG&A expenses and lower R&D costs related to clinical trial and regulatory activities. For the 6 months ended June 30, 2022, non-GAAP operating expenses were down 7% compared to the same period last year. As a reminder, we project R&D expense in 2022 to be primarily driven by manufacturing costs for DaxibotulinumtoxinA for Injection which according to GAAP accounting standards, our expense to the period costs until the drug product is approved. As for our operating expense outlook, we maintain our previously announced GAAP and non-GAAP expense guidance for 2022. Turning to our balance sheet. Our total cash, cash equivalents and short-term investments as of June 30, 2022 were $233.8 million. Recall that we enhance our financial flexibility earlier this year with the closing of a $300 million note purchase agreement with Athyrium Capital. We issued the first $100 million note payable on the closing of the agreement in March 2022. Pending the approval of DaxibotulinumtoxinA for Injection, we will have the option to initiate issue another $100 million note until September 2023. An additional option of uncommitted borrowings of up to $100 million is available on commercial revenue target achievement. We believe, we have the cash runway into 2024 with the additional $100 million in committed notes available subject to the FDA approval of our neuromodulator. Finally, Revance's shares of common stock outstanding as of July 29, 2022 were approximately $73.1 million with $80.7 million fully diluted shares, excluding the impact of convertible debt. And with that, I'll turn the call back over to Mark.

Thank you, Toby. Our commercial track record since launching two years ago continues to give me confidence in our people, strategy and our innovative portfolio of products and services. Importantly, it also gives me confidence in our ability to successfully launch DaxibotulinumtoxinA for Injection get approved and to begin realizing our therapeutic potential post-approval. I'd like to thank the clinical, manufacturing, operations and regulatory team for the successful resubmission of our BLA and for their hard work in preparing for the recent re-inspection of our manufacturing facility. I'd also like to thank the commercial team for their excellent performance in the first half of the year. We look forward to the tremendous opportunities ahead and to updating you on our progress along the way. With that, I will now open the call up for questions. Operator?

[Operator Instructions] And our first question comes from the line of Seamus Fernandez with Guggenheim Partners.

Thanks for all the detail on the manufacturing and FDA updates, guys. So just a couple of quick questions there. As you review the additional observations and first off, congrats on closing the 5 observations. I’m sure that was challenging and a great relief to see that closed out. But on the 3 additional observations, they strike us as minor as we kind of read those observations. But what does your consultants kind of say about those observations and can you just give us any color on your thoughts? It obviously seems like you feel quite good heading into the PDUFA date on September 8. And the second question, just wanted to get a little bit of the color as we speak with physicians, some experts basically talk about their experience in clinical trials with DAXI seeing a little bit of a different sort of spreading dynamic versus what one might experience with BOTOX. How are you guys, how do you think about that? Is that sort of a clinical advantage from your perspective or is it something that will become a clinical advantage once the physicians are actually experienced with the product?

Thanks, Seamus. So first off, you mentioned we're very pleased with our ability to retire the 5 observations from the original Form 483 observations. And to your point, it was great work by the team to quit the resubmission package together to address sort of the outstanding items that were agreed upon with the agency where we needed to re-qualify that cell banks. So again, it's certainly heartening to us and the team to close out those 5 observations. It's probably not appropriate for us to comment on kind of on the 3 observations that we got this latest go around just because of where we are with the agency that we said normally we wouldn't be commenting on these things. But given the news that we received this morning that a redacted version of our Form 8 -- Form 483 may become public prior to our PDUFA date, we thought was important that all shareholders have the same information. But we feel very good about the responses that we pulled together. They were complete, they were comprehensive. There is nothing else in outstanding related to the responses to those 3 observations and we continue to feel very good that we'll get a response from the agency on our application by the PDUFA date of September 8. In terms of your second question regarding color on DAXI and does it spread differently or anything like that. We long talked about sort of a staged rollout that we're going to go through but I'd like to hand it over to Dustin, so he can provide a little bit more commentary on that.

Yes. Thanks, Seamus for your question. I think if we look at the majority of the study work that was done with DAXI within glabellar line and it was very, very well received by those injector sites. We've got to remind the DAXI is the first and ever unique formulation that is stabilized with our proprietary peptide. So it will act a bit differently with other products. As it relates to specific spreading or different characteristics relative to that, I’m not aware of any data that is able to compare with that. It’s actually some of the data that we actually just released at Toxins Talks about the positive charge the finding and anchoring of how that peptide stays attached to the daxibotulinumtoxinA molecule, once it’s been reconstituted. So you ultimately would think that there is actually a different effect and that you would have more of an anchoring effect around those areas. Obviously, as Mark mentioned, this is a different product and it will take a little bit of time for the practices to find their specific recipe. We’re really happy with the results that they have in clinical trials. Once they go into real world setting, they would like to tweak things based off of look that they have. And so, we look forward to providing them the opportunity with our preview program. But all in all, we’ve been very pleased with both the efficacy, duration profile and the safety profile DAXI across both glabellar line and then with our upper facial lines, lateral canthal lines and ultimately forehead lines Phase 2 data.

And your next question comes from the line of Ken Cacciatore with Cowen.

Maybe I’ll just try to follow-up and see if I can get a bit of a different answer. Is there any sense as you look at these observations, whether there would be a need to actually on-site, inspect? And then maybe part of that, can you talk about whether we’re engaged in label discussions? Just wondering if you can give any more detail. And then in terms of the rollout, I know previously we talked about wanting to be a bit selective as we rolled out DAXI with the hopeful approval. Mark, if you can give us a little bit of sense, is it going to be necessary for you to actually train a clinician? Do they have to kind of get through a bit of a process? Can you just talk about how you’re going to come to roll this out in the 4,000 accounts that you currently have? Can you give us any sense about the volume that they do, this is a situation where these accounts are 50% of the botulinum toxin volume or I’m throwing out a random number to see if you’ll contextualize for us kind of the initial account basin and what their current volume is in terms of botulinum toxin?

Thanks, Ken. So in regards to your first question, do we expect with the 3 observations that we summarized in the recent Form 483 to expect reinspection? We provided comprehensive responses to the observations. There is no additional data that we're waiting on. I mean not appropriate for us to comment exactly on how the FDA will receive the responses. But we feel very good in terms of what we were able to put in the responses and felt that we were able to provide a comprehensive response to the -- for identifying. And so we continue to believe that this September 8, PDUFA date is a good day and again, going back to kind of the comment earlier, we feel really good that we were able to close out the 5 observations from the original Form 483. On the label itself, again when we received sort of the CRL last time, we communicated at that point in time that we -- everything else had already been wrapped up at that point. The only thing was outstanding with the inspection of our facility and so there is no new updates there. We believe that the FDA label negotiations were already included. And so there is no update to that. So the last one in regards to sort of the rollout of DAXI, I'll hand this over to Dustin in a second but we often sort of characterize the market is roughly 40,000 accounts of which you know we're targeting the top third as part of our prestige strategy. So this call 13,000 to 15,000 accounts really in 4,000 of those. They were still in a subset of those accounts. And so, we still have ways to go. I don’t know that we’re in a position to be able to comment in terms of the percent of the toxin market that those 4,000 accounts occupy. But I’ll let him speak to sort of the rollout on strategy in greater detail.

Yes. And thank you, Mark. So as it relates to DAXI, we're going to follow the proven track record we've had for rolling out products with our preview program. Although this will bring some of our providers to our Nashville headquarters. We were able to rollout a significant training program focused really on 3 areas. First, clinical. As you know we need to go through the clinical duration profile of DAXI from an efficacy perspective and safety perspective, both across all of our clinical trial Phase 3 and Phase 2. We will also talk about our formulation. Mentioned earlier, this is the first and ever formulated product with the peptide that delivers efficacy in duration with similar amount of API and other products in the markets. We'll go through that. And then lastly practice integration. We see often it's important for practices to understand, not only the profile, how to inject the product but how to actually integrate into practice, how to charge and how to convince consumers it's the right product for them. So focus on all of that will also get those key learnings through that period of time around the minor fleets that injectors will make around kind of the recipe for exactly how they like to utilize DAXI in a real world setting. And then we'll go broader into our practice partners. The RHA, folks that have leaned in without RHA, as well as with OPUL. And then, just a comment on your final question. We felt like the prestige category represents roughly 50% of the aesthetic marketplace. And so we feel very good that the foundation for the accounts that we're in will be a great foundation to start for DaxibotulinumtoxinA for Injection.

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

Just a follow-up on the rollout. Can you just confirm that the rollout that you plan, is it already full overlap with those accounts that are using RHA filler or are you reaching out to different accounts who may have not adopted RHA filler but were very, very close, like KOLs or clinical who had already used DAXI. So I’m just curious about that. And the second question I have is, you know, we’ve all done surveys regarding the reception to long-acting products and clearly they are viewed as very differentiated and they would have strong reception, strong penetration. But there are some view still in the market that this would still be niche, because if you drill down a little further, they may not use it as broadly -- in the broad population as typical. So what are you finding when you drill down with your -- in your market research today? Do they receive and expect penetration of broadly is what we’re receiving in our surveys that we do probably unless detailed forecasting you do? Thanks.

I'll take first those, then Mark can add on if he feels appropriate. So on the rollout, no, I'm not in a position to go specific physician-by-physician, injector-by-injector. But our first and primary focus is on outcomes. Who are going to be those that are going to help us through this process and focus on getting great outcomes and also those that have leaned in with us will be a combination of those groups. It’s important to look at how providers learn from each other in today’s environment, both from a podium perspective but also from a hands-on perspective and also those that are willing to work with us on this journey of how do we maximize that practice integration, learn from those launches that happened previously. So it’ll be a combination of those groups. As it relates to kind of our market research, we feel very good that the consumer uptake and the practice uptake of this product will be well received. It’s got a unique value proposition that it is the first product. It offers something different to botulinum toxin patients both from an efficacy perspective and a duration perspective. All others are formally more similar to the same. With this peptide and our clinical profile, we believe that whether they’re getting toxin 4x a year or more likely, most of them getting toxin 1.8x times a year. This is going to have a value if they get injected with DaxibotulinumtoxinA for Injection twice a year, that aesthetic looked at they will receive with DAXI, will be different than anything that they have had with other toxins. And so we feel really good that it can add value across a variety of segments.

Yes. And I'll just still add to that, Annabel. So we certainly don't see this as a niche market. Certainly, it will have its place and we long talked about the nice thing about having a long-acting alternative is it gives practices and consumers a choice. And so it doesn't need to be a one size fits all but we'll provide, we believe the valuable alternative for both patients and practice. Our market research suggests that both consumers and injectors identifying the lack of duration is being the number one unmet need and that's reported out at over 80% in both of those categories which toxins is kind of amazing that you've got these procedures that are being done millions of times a year. And despite that, they continue to express disappointment with the duration of the existing products. And so, we believe that this will be a really nice add to the armamentarium of the practices and the providers and an alternative for consumers and we don't expect it to be everything to everybody but we do expect it's going to resonate and that will be a large portion of patients and injectors that look to this is an alternative.

And your next question comes from the line of David Amsellem from Piper Sandler.

So just couple of questions. Just going back to the Form 483, I guess maybe I'll sort of take a different angle and ask you, Mark, if you were surprised at getting additional observation. Is this something where you were caught flat-footed or there is something that you had an inkling might happen. Just wanted to see if we can gain any insights there? And then secondly, on RHA. You talked about consumer behavior and you’re not seeing anything beyond seasonality. I mean, I guess the question is going forward as the footprint of the product grows to the extent there is still, these macroeconomic pressures. Do you look at 4Q which is the strongest season in this phase as potentially a trouble spot, if you will? I -- to get your thoughts on how you think that part of the year might play out, given the backdrop that we’ve been talking about.

Yes, thanks, David. So first question, were we surprised or disappointed? I mean clearly, when you prepare for an inspection, you're hoping that you all can have any observations, right. So but I'll say but the team did an amazing job and they're going to come back to the fact that we closed out the 5 observations from the first Form 483. So I think the team did a great job there. As you’ll see from the summary that we provided Items 1 and 2 related to single development batches, where we get a follow kind of a procedure or in SOP, hence you’re talking about a single batch where that was the case. We provided very comprehensive responses, there is nothing else that’s outstanding. And so certainly everybody would love not to had any observations but we liking it sometimes to home inspection. You kind of get prepared and you’re ready and the findings. But again, I think our team did a great job. And again, I’ll come back to very proud and pleased with sort of the timeliness and the comprehensiveness of the response that was put forward. In terms of consumer behavior, I think there’s a few things that are worth noting. First off going into Q4, we’ll have to wait until we are closer to that to make any commentary on the Q4 side of things but you know, as you’re aware, this is a market segment that has proven to be fairly resilient through other economic downturns 2008-2009 coming out of the pandemic these are procedures, certainly, the facial injectables that start to become a little bit more integrated into lifestyle and so they’re less sort of discretionary and more conventional for these patients. And so, maybe it’s that we’re calling on a smaller subset of practices that we are kind of lumping into this prestige category. But thus far, or at least today, we’re just not seen sort of a softening and even if you go back over time and you look at periods of time where macroeconomic conditions did plan it did have an impact but it was certainly more muted than other discretionary spending items. And as we pointed out before, we’re also in kind of a launch base with re-density, having just launched on the RHA side, we’re still early in 4,000 accounts and for our neuromodulator, if approved that’s going to give us yet another new innovation to bring into the market. And so, we’re going to have some things that counterbalance any macroeconomic conditions should they and to be more pronounced in Q4 going forward.

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

And I guess regarding the third observation mentioned in the press release about not adding redundant sites, the storage of the working cell bank, I think the last form for a degree mentioned the lack of having a working cell bank, can you just remind us what are the issues with having a working cell bank and how difficult is it to add this redundant sites and the fact that may be the working cell bank if it doesn’t seem to be repeating again now that within this 3 new observation. Can you just kind of, I guess, when I’m talking through this and clarify as much as you can?`

Sure, Tim. So, we use sort of third-party redundant facilities to store and maintain some of our cell bank material for kind of more disaster purposes. This is a third-party signed that is already registered with us that we already used. And so, the issue for number 3 was that in our BLA filing, we had not updated that site to include the newly qualified working cell banks. So, we took care of that, we did in our filing address the addition of the new working cell bank to that third-party redundant storage facility which is already under registration with us.

Okay. That sounds easy enough. I guess from a 10,000-foot [ph] perspective, I know, none of this is easy when it comes to manufacturing but the lack the kind of on validated working cell bank was raised again does that -- are we able to kind of jump ahead and think that was all of those issues have been mitigated from the last Form 483?

Yes, that’s what we tried to communicate in sort of our prepared remarks. So, the lack of a qualified cell bank at the time the FDA showed up the last time was part of one of the 5 observations and we indicated that after our Type A meeting, the FDA was clear in terms of what they needed to see from us in order for us to resubmit our BLA and provide them with the necessary information and ultimately what they wanted with the qualification of the new cell bank with 3 consecutive drug substance batches in one drug product app. So, we provided all that information in our resubmission and at the recent inspection of our facility, they indicated that we have successfully addressed the 5 observations in the original Form 483. So we feel very good and those have been closed after. There is nothing open right now as it relates to the cell bank or the qualification of the cell bank. The summary that we provided of the Form 483 is that we’re recently provided are the only things that are outstanding. And again as I mentioned, we have provided all of the responses to those 3 questions with nothing that remains us any piece from our end.

Your next question comes from the line of Douglas Tsao from H.C. Wainwright.

Hi, good afternoon. Thanks for taking the questions. Just going back to the 483, I just want to clarify this one point. So, it sounds like both these observations were related to a single lot but it sounds like this lot was boarded. So, with this lot -- this lot to clarify or confirm was not used to satisfy the requirements of the original Complete Response Letter?

That's correct, Doug. So, these are two individual development lots. The one was awarded based on sort of the league that be summarized, there. The other one with a separate development block neither then used for any sort of clinical trials for sort of our validation process. These were independent development loss.

Okay, great. And so they don’t, just to confirm again they don’t affect BLA in any way or sort of the meet of the BLA besides just addressing these process issues which I know are important but they don’t have implicate -- broader implications for the FDA’s evaluation of the BLA?

Yes. I mean, I don't want to go so far as to speak on behalf of the FDA on that side. But yes, I mean these were not lots or batches that were included in our validation of our new working cell bank. These were sort of one-off observations related to drug substance, single drug substance lots that were development launched.

Okay, great. And again, wasn't far enough to speak for the FDA and I understand that sensitivity. And then just maybe stepping back, I just want to -- congrats on the performance of the RHA line. You know, your key competitor in the filler market didn't have nearly as good performance in the second quarter. You were up I think 22% sequentially and they were sort of down meaningfully on a year-on-year basis. So I'm just curious if you saw anything in the market. I know there has been some concerns about the sort of macro environment just given the broader sort of an economic environment. I was just curious if you saw anything, is there anything that might have spoken to what your largest competitor saw?

You know, I'll head it to the beginning and then hand it over to Dustin if he got any additional color to add. I'd say that really again we're in launch phase to really are mean sort of focus is finding accounts that are willing to sort of try and evaluate RHA filler line and then obviously trying to drive deeper kind of fit penetration in those accounts and we're doing that through training and education, peer influencers that are sharing their experiences and outcomes. And I think with the methodical approach that we've taken, we're seeing nice uptake. RHA Collection is a great collection. So I think you're seeing it as a product line that adding something that's incremental to what they have due to sort of the natural way that the product moves there. And I also think it's a reflection of the strategy that we've taken. We've taken a very deliberate strategy focused on prestige accounts, where we've got transparent pricing, we're trying to help make sure that they're getting the right outcomes and that this is a profitable and value-added service for us. And so, we did in the quarter, we just sort of steady issue goes, continuing to drive more account growth in a little bit deeper penetration. But Dustin, I don’t know if you want to add anything to that?

So I think you hit the fact that it's a differentiated strategy not built around couponing and not built around programs at certain point in time. I think you heard the commentary from that organization around how they had program in certain time to drive certain behaviors and we have built our business on this product being uniquely formulated, uniquely adding value to both the injector and the consumer. And we're going to continue to leverage that. And so, we've got a nice opportunity in front of us with 4 different SKUs that allows us to go deeper into accounts but also as Mark mentioned, we've got an opportunity to expand our account base. So we're in a very unique and different position in some of those competitors and we feel good about that employees continue to leverage that. And so, we've got a nice opportunity in front of us with 4 different SKUs that allows us to go deeper into accounts. But also as Mark mentioned, we've got an opportunity to expand our account base. So we're in a very unique and different position in some of those competitors and we feel good about that and poised to launch the portfolio.

Okay, great. Thanks very much and congratulations on the progress.

And your last question comes from the line of Serge Belanger from Needham & Company.

Good afternoon. I guess I’ll get in on the topic is your -- in terms of new Form 483 observations, Now that you’ve submitted your responses, are you expecting any kind of feedback from the FDA if they close the issues out or provide additional suggestive actions to rectify these observations?

It's certainly possible we could hear something back. At this point, we've not heard anything back. We provided our comprehensive responses to the agency and it's quite likely that we won't hear anything back other than sort of their final decision on the PDUFA date.

And if you hear some back would that be something you would disclose or it depends on the nature of the response?

Yes. I mean, I think you say never again, our bias is towards not providing ongoing interaction with the agency could imagine there is a variety of flavors at that takes and that's our normal protocol. Unfortunately, had to break from that a few times due to the redacted Form 483 that were put out there in our awareness this morning that we would likely get another 483 put out there prior to our PDUFA date. So unless we thought it was something that significantly compromise our approvability, we would not be commenting on that.

Okay, fair enough. And then just a broader market question. Based on the earnings reports of other toxin companies, this is a market that, at least in the last 2 or 3 quarters is significantly outpaced its usual high single-digit to low double-digit growth rates. Just curious how that changes your pricing in following strategies for DAXI?

Yes. Serge, this is Dustin. I think, first side, right. The more growth, the more opportunities for all players here especially one that has the first innovation in 30 years. And so we feel really good about our capitalization on that opportunity. And in any market, especially when that's growing, innovation comes at a premium. And so we feel good about our pricing strategy. We feel good about both is the premium opportunity that we have in launching something. This innovation that provides value to both the injector and the consumers. So, I don't think anything we've seen really kind of changes our launch strategy today just the more the merrier, we're happy that the market continues to grow and we look forward to capitalize on that.

Got it. One last one, you talked about your plans to submit the sBLA for cervical dystonia. But what about plans to re-initiate development of other therapeutic indications, upper limb spasticity is the obvious one. But you know on the past, you’ve also talked about migraine indication?

Yes. Serge, I think, we want to get through approval and into the market and then revisit that based on sort of our capital allocation and sort of where we want to focus our dollars. But clearly, the be filing our sBLA for cervical dystonia will represent our first foray into therapeutic. And more particularly, the muscle movement disorder category which is sizable and we're encouraged about that. So, I think about this is that these are markets that continue to grow and expand and we believe that the promise of a long-acting neuromodulator in the category will still resonate over time and so we’ll get back to you. We feel we’ve got more clarity around what’s the right time to advance the therapeutic program beyond cervical dystonia.

This ends our Q&A session and today's conference call. Thank you for your participation. You may disconnect at this time. Goodbye.