Revance Therapeutics, Inc. (RVNC) CEO Mark Foley on Q4 2021 Earnings Call Transcript

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Revance Therapeutics, Inc. (RVNC) CEO Mark Foley on Q4 2021 Earnings Call Transcript


Revance Therapeutics, Inc. (NASDAQ:RVNC) Q4 2021 Earnings Conference Call February 28, 2022 4:30 PM ET

Company Participants

Jessica Serra – Head, IR & and ESG

Mark Foley – CEO

Dustin Sjuts – President

Toby Schilke – CFO

Conference Call Participants

Ken Cacciatore – Cowen and Company

Alena Seamus Fernandez – Guggenheim

David Amsellem – Piper Sandler

Annabel Samimy – Stifel

Balaji Prasad – Barclays

Tim Lugo – William Blair

Douglas Tsao – H.C. Wainwright

Serge Belanger – Needham & Company

Disclaimer*: This transcript is designed to be used alongside the freely available audio recording on this page. Timestamps within the transcript are designed to help you navigate the audio should the corresponding text be unclear. The machine-assisted output provided is partly edited and is designed as a guide.

Operator

0:04 Welcome to the Revance Therapeutics Fourth Quarter and Full Year 2021 Financial Results and Corporate Update Conference Call. At this time, all participants are in a listen-only mode. Following management’s prepared remarks, we will hold a Q&A session. To ensure that we have ample time to address everyone’s questions during the Q&A session, we will ask for a limit of one question and one follow up question per person. [Operator Instructions].

0:42 As a reminder, this call is being recorded today, Monday February 28th, 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.

Jessica Serra

0:58 Thank you, Victor. Joining us today on the call 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 potentional approval and timing of approval of DaxibotulinumtoxinA for Injection in glabellar lines as well as in therapeutic indications, plans related to RHA collection and OPUL platform. Our financial performance processing volume run rate, 2022 guidance, expected cash runway, strategic priorities, and capital allocation plans, our market and revenue opportunity and the market demand for our products and services and our business strategy, planned operations and commercialization plans.

1:47 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 huge risks and uncertainties. Also on today’s call, we will present both GAAP and non-GAAP financial measures. A reconciliation of non-GAAP to GAAP measures is included in our earnings release.

2:13 With that I will turn the call over to Mark Foley Chief Executive Officer of Revance. Mark.

Mark Foley

2:20 Thank you, Jessica. Good afternoon, everyone. Thank you for joining our fourth quarter and full year 2021 financial results conference call. With that 2021 marked Revance’s first full commercial year and we cannot be more pleased with our execution, ending the year with over $72 million across our products and services. These results were led by RHA collection, the latest advancement in hyaluronic acid dermal filler technology that continues to gain share in the large and growing US filler market. We now have over 3,000 accounts in the US across our dermal filler and fintech platform, which generated over $0.5 billion in gross payment volume for the year.

2:59 Our focus on innovation and our customers will continue to be core to our ability to scale in the years ahead. Coming into 2021, we have 5 key strategic priorities. Obtaining FDA approval for DaxibotulinumtoxinA for injection for the treatment of glabellar lines, following the deferred action of our PDUFA date in November of 2020. Strong commercial execution, advancement of our therapeutics franchise, disciplined capital allocation, and a focus on our people culture and diversity and inclusion.

3:34 I’d like to take a moment to review how we track these priorities as well as provides some recent updates. First, while we did not receive FDA approval for our neuromodulator products as we had anticipated, we made meaningful progress in advancing our regulatory path. Earlier today, we announced that we’ve successfully manufactured 3 consecutive drug substance slots, and one drug product lot as required by the FDA for the qualification of our new working cell bank. The completion of the manufacturing activities paves the way for the resubmission or BLA for DaxibotulinumtoxinA for injection for glabellar lines as soon as possible. You’ll recall that based on our Type A meeting with the agency in December, a complete response to address the outstanding observations related to, 1 the qualification of our new working cell bank, and 2, our drug substance manufacturing process required us to qualify our new working cell bank by producing 3 consecutive drug substance lots and 1 drug product lot. Qualification process was already underway at the time we announced our Type A meeting results, and we were very pleased to have completed the qualification activities in a timely manner. We are now working on a resubmission package and will provide an update once we have resubmitted our BLA.

4:55 As we’ve indicated previously, and based on our Type A meeting, our re-inspection of our manufacturing facility will be necessary once a resubmission is accepted by the agency. Further based on FDA regulations, once the resubmission is accepted, the agency has up to 6 months to complete its re-inspection of our facility, along with the review of our resubmitted BLA. We remain focused on getting our neuromodulator product approved as soon as possible and look forward to engaging with the agency to facilitate this process.

5:28 As I already dressed our commercial execution in my opening remarks, I will now turn to our third strategic priority for 2021, the advancement of our therapeutics franchise. In 2021, we successfully completed both our ASPEN Phase 3 clinical program for cervical dystonia and our Phase 2 clinical program for adult upper limb spasticity. The completion of our cervical dystonia clinical program, marked the second successfully completed Phase 3 program for DaxibotulinumtoxinA for injection, demonstrating that the drug was generally safe and well-tolerated with an extended duration profile across both therapeutic and aesthetic indications.

6:08 For our adult upper limb spasticity indication, we completed the Phase 2 clinical program and also held a productive and the Phase 2 meeting with the FDA, which informed the requirements for Phase 3 program for this indication. Given our progress, we are poised to file a supplemental BLA and cervical dystonia following the approval DaxibotulinumtoxinA for injection in glabellar lines. For adult upper limb spasticity program, given some of the cash conservation measures that we implemented late last year due to the delayed approval of our neuromodulator. We have paused the commencement of that Phase 3 program and we will continue to evaluate the proper timing for its initiation.

6:54 Turning to capital allocation, we have been disciplined in evaluating and pursuing opportunities that will generate the highest return for our stockholders. To that end, we have been prudent in our efforts to balance growth and costs throughout the year, particularly following our CRL to maximize our financial flexibility. These ongoing efforts have allowed us to end the year with cash into 2023.

7:19 Finally, in spite of the challenges presented by our remote and hybrid work policies due to the COVID-19 pandemic. We have worked hard to foster employee engagement while also creating strong culture that embraces diversity and inclusion. These priorities involve programs and initiatives across all levels of the organization. Of note, we successfully met our corporate diversity and inclusion goals for the year spanning across talent acquisition, and internal educational and leadership forums.

7:52 Before I turn the call over to Dustin to walk us through a fourth quarter operational achievements, I would like to review our strategic priorities for 2022. First, our primary goal remains gaining FDA approval for DaxibotulinumtoxinA for injection in glabellar lines as soon as possible. We’re actively working on a resubmission, which will bring us one step closer to that goal. Our second priority is to continue to drive top line growth for products and services, which will continue to be anchored by the RHA collection of dermal fillers in 2022. Third, we plan to drive deeper penetration of our OPUL relational commerce platform, now that we have completed the PayFac migration and are able to expand the platform’s functionality. Fourth, we will continue to focus on discipline capital allocation to drive long-term value for our stockholders. Fifth and finally, we will continue to invest in our people and our culture upon which our success is built.

8:51 I’m thankful for all the efforts and dedication of the Revance organization in 2021, and I look forward to our shared success in 2022. With that, let me turn the call over to Dustin who will cover performance in the fourth quarter. Dustin?

Dustin Sjuts

9:06 Thank you, Mark. Let me start by echoing your appreciation to everyone in the organization for all the hard work and progress we’ve made during the year across both aesthetics and therapeutics. In 2021, we capped off our first full year of commercialization are recording over $70.8 million in total RHA sale. These results are driven by RHA innovative technology and a strong execution across our advanced aesthetic strategy, which continue to differentiate Revance from other competitors.

9:38 In the fourth quarter, RHA sale pulled $23.8 million representing an increase of 138% over our first launch quarter, supported by new account growth, increased account productivity and the impact of traditional seasonality. The second and fourth quarters are typically the strongest periods for static procedures to each calendar year.

10:02 We’re excited to build on RHA momentum in 2022, particularly as we leverage cross selling opportunities in our products and services and as we introduce RHA Redensity to our collection. You’ll recall at the end of 2021, our partner Teoxane SA, received FDA approval for RHA Redensity, which was previously referred to as RHA 1. The approved indication for the treatment of moderate-to-severe dynamic perioral rhytids or lip lines further augments the versatility of the RHA collection, providing injectors with a wider range of treatment options. The product was well received by investigators in clinical trials, and we look forward to launching Redensity in the second half of the year.

10:46 The RHA collection now includes 4 distinct formulations that are dynamic, natural and adaptable. We are currently working with Teoxane to bring new filler innovation to the market that will enable us to continue to fulfill the unmet needs of both injectors and consumers.

11:04 Turning to our FinTech platform, an important highlight of 2021 was the launch of OPUL. OPUL designed to help aesthetic practices optimize operations while enhancing consumer relationships. It’s the first of its kind relational commerce platform for the Aesthetics industry. Initial launch features include seamless payments, practice reporting, and analytics, and customizable checkout options containing a catalogue of over 6,000 SKUs. We are currently developing new features to enhance adoption and retention. The team is leveraging practice insights to develop membership programs that will be meaningful to both practices and consumers.

11:48 We began 2021 with a payment processing run rate over $200 million and through increased account penetration, we’re able to nearly triple that run rate to almost $600 million at year end. As we previously indicated payment processing volume is a key performance indicator for our FinTech platform. Going forward, we’ll be providing our gross payment volume, or GPV, defined as the total dollar amount of all transactions processed in the period to our OPUL and HintMD platform’s, net of refunds.

12:21 For the full year 2021, our GPV was $506 million. In 2022, our goal is to continue to grow our accounts, develop new features and complete the migration of our legacy HintMD customers to OPUL. With that, I’ll turn the call over to Toby to cover our fourth quarter and full year financials.

Toby Schilke

12:44 Thank you Dustin, we are pleased to report strong financial results for the fourth quarter and for the year. Revenue for the fourth quarter and full year 2021 was $26.0 million and $77.8 million, compared to $11.1 million and $15.3 million for the same period in 2020. Revenue growth on a quarterly and annual basis was driven primarily by increased sales of the RHA collection of dermal fillers. Revenue for the fourth quarter included $23.8 million of product revenue from the RHA collection of dermal fillers, $1.6 million of collaboration revenue from our partnership with Viatris and $0.5 million of service revenue from our fintech platform. For the year, 2021 revenues included $70.8 million of our product revenue, $5.7 million of collaboration revenue and $1.3 million from our FinTech platform. For the year 2021 revenues included $70.8 million of our product revenue, $5.7 million of collaboration revenue, and $1.3 million from our FinTech platform.

13:52 Operating expenses for the fourth quarter and full year 2021 were $87.6 million and $352.5 million for the full year, excluding depreciation and amortization and stock-based compensation. Non-GAAP operating expenses were $63.3 million for the fourth quarter and $265.8 million for the year. As previously mentioned, our capital allocation at this time is focused on obtaining FDA approval for DaxibotulinumtoxinA for injection, driving top line growth with our products and services, expanding and deepening our customer relationships through OPUL and investing in our people and culture.

14:37 We have also taken prudent steps to conserve and preserve cash by pausing non-critical hires deferring a Phase 3 clinical program for upper limb specificity, as well as other therapeutic pipeline activities and pausing international regulatory and commercial investments for DaxibotulinumtoxinA for injection, with the exception of our collaboration with folks on in China.

15:03 Due to these efforts, our GAAP and non-GAAP operating expenses for the year or below our previously announced guidance ranges. Looking ahead, we expect 2022 GAAP operating expenses to be $375 million to $400 million and our non-GAAP operating expenses, which exclude costs of revenue, depreciation and amortization and stock-based compensation to be $260 million to $280 million. Further, we expect non-GAAP research and development expense to be $100 million to $110 million.

15:45 R&D expenses in 2022 are primarily driven by manufacturing costs for DaxibotulinumtoxinA for injection, which according to GAAP accounting standards are expensed as a period cost until the drug product is approved.

16:04 Turning to our balance sheet, cash, cash equivalents and short-term investments as of December 31, 2021, were $225.1 million, which we believe is sufficient to fund our planned operations into 2023.

16:21 Finally, Revance’s shares of common stock outstanding as of February 17, 2022, are approximately $71.5 million with $78.2 million fully diluted shares, excluding the impact of convertible debt.

And with that, I’ll turn the call back over to Mark.

Mark Foley

16:41 Thank you, Toby. In closing, we have a differentiated commercial strategy that is delivering the desired results, while also allowing us to forge inroads into elite aesthetic practices that will provide us with a strong commercial foundation for our neuromodulator once approved. Our main priority for 2022 is obtaining FDA approval for DaxibotulinumtoxinA for injection in glabellar line, which should not only accelerate our growth in aesthetics, but will also pave the way for us to advance our therapeutics opportunity by filing a supplemental BLA for cervical dystonia. I’d like to thank all of our stockholders for your continued support for Revance. I look forward to updating you on our progress in the new year.

17:26 With that, I will now open the call up for questions. Operator?

Question-and-Answer Session

Operator

17:31 [Operator Instructions] Our first question Ken Cacciatore from Cowen. You may begin.

Ken Cacciatore

17:45 Thanks so much. Great to hear all the progress, guys. Mark, just wondering on the timing of the refiling. Can you help us characterize that? Is it weeks or is it months? Can you – can you put a little bit of context around would be great and then is there anything else from the 483 (ph)? Or we just waiting here on the filing for the working cell bank the qualification of it? Thanks so much.

Mark Foley

18:10 Yeah, I can. So for the first one, the timing, we’re — we’re not going to give specifics on it. But clearly, the long lead item was the qualification work related to the new working cell bank. So at this point, it’s a little bit more administrative in nature to just pull everything together and as we indicated, we will definitely put out a public announcement once we have refiled the BLA. So obviously, this is a high level of focus for us. And again, it’s more administrative in nature at this point.

18:40 In regards to the 483, previously, we said there were 543 in our responses to the agency items 3 through 5, the agency indicated our responses appears efficient and then for items 1 and 2 went into the Type A meeting for and that Type A meeting coming out of that – the what the FDA wanted to see was the qualification of the new working cell bank, with three consecutive drugs substance and one drug product path. So, that’s what we’ve been working on providing, in the actual complete response, we will need to just sort of update the clinical portion of our applications from a safety perspective and as it relates to the name, just another name search on that, but that’s pretty much it and we’ve been aware of that and we’re working on those activities in parallel.

Ken Cacciatore

19:32 Great. Thanks so much.

Mark Foley

19:32 Thanks.

Operator

19:37 Our next question comes in line Seamus Fernandez from Guggenheim, you may begin.

Unidentified Analyst

19:44 Hey, there, this is Alena on for Seamus, thanks for taking your question and congrats on quick turnaround with the [Indiscernible]. So we just have a question regarding, any potential range of options that you’re considering for financing the company beyond ’23 and in particular, any interest in a royalty transaction that would not only raise capital, but validate the potential peak sales on DAXI? Any color on that would be would be great. Thank you.

Toby Schilke

20:14 Thanks a lot. This is Toby Schilke. You know, as we noted on the call, we have sufficient cash to fund our operations into 2023. Given our revenue profile and late stage that we are Daxi, we have optionality. Obviously, extending our cash runway is a key priority and, we’ll take a thoughtful approach for a variety of financing strategies to balance where we are with our cash needs, so while we cannot comment on the specifics, we are taking this as a top priority.

Unidentified Analyst

20:50 Awesome, thank you very much.

Toby Schilke

20:52 Welcome.

Operator

20:54 Our next question will come from David Amsellem from Piper sander, you may begin.

David Amsellem

20:59 Hey, thanks. So just a couple on RHA via with the approval. I think that’s the RHA 1, SKU, can you talk about the extent to which that could provide an incremental bump in the sales trajectory or just talk about that opportunity in general? And then secondly, just the broader question about the market here. Obviously, you had a good first year and the products growing. I know you’ve said in Europe, your shares something like 9% or 10%. Do you think that’s where peak share could be in the United States? Do you think it could be higher? How do you think about that, in general? Thanks.

Mark Foley

21:47 Okay. Thanks, David. I’ll have Dustin answer that first part of that, and maybe I’ll think crack a little bit the back part of it.

Dustin Sjuts

21:47 Sure. So yeah, thanks, David. So we’re really excited about the approval of RHA Redensity, which you agree – which you did mention was formerly called RHA 1 as the only approved filler for dynamic perioral rhytids or lip lines, the perioral region is a bit challenging to treat because of the structure of the facial anatomy. So we feel that RHA Redensity will give us a unique opportunity and add yet another tool in the toolbox for our injectors. RHA is built off of a technology that allows us to be mimic the most natural RHA that continues between RHA 2, RHA 3, and RHA 4 and RHA Redensity. So we look at this being a nice addition and allows us to continue to kind of talk about innovation profile. As it relates to kind of volume, as you imagine, declines and small more superficial areas is a high volume utilization of a filler, nor is that the first thing most people come in for, we feel like it’s a nice icing on the cake that allows us to continue to kind of highlight the portfolio. So with the thin the filler space, you see that we’re constantly use this constant stream of innovation to keep being relevant training new injectors, allow us to continue to highlight that technology.

23:05 So without talking over more, pass it over to Mark.

Mark Foley

23:08 Yes, just the thing, David, on your comments about market share, what we’ve previously said that Teoxane, in their top 5 EU markets had roughly 10% share. And our share of the market right now depends a little bit on kind of what data you’re looking at for the market, the last day that we had was sort of $1.1 billion in the US and so we’re trending towards high single-digit penetration right now. The market continues to grow. So we’ve been encouraged by what we’ve seen there, we certainly don’t feel that there are constraints in our opportunity in terms of penetration that are going to be limited to where [Indiscernible] in their top market. And partly because there’s fewer competitors in the US and we do think that once or neuromodulators proved that it’s going to allow us to compete certainly more effectively from a bundling standpoint in meeting all the needs of the injector. So we certainly are pleased with where we are from a start, and we do believe that once or neuromodulator is approved, that it’s going to give us additional opportunity to continue to drive deeper discounts.

David Amsellem

24:15 Okay. Helpful. Thank you.

Mark Foley

24:17 Thank you David.

Operator

24:19 Our next question comes line of Annabel Samimy from Stifel. You may begin.

Annabel Samimy

24:27 Hi, thanks for taking my question. Congratulations on the progress. I suppose you’re not commenting on the timing of the resubmission. But in the past, you’ve talked about hoping to get a launch before the end of the year and approval by the end of the year. Are you still planning on that if everything on the regulatory front goes according to plan following resubmission? And then secondly, on Revance just making quite an effort building up the Aesthetics platform and working closely with practices with OPUL and then in the FinTech platform, then maybe premature to ask us but what any of these activities be precluded when you start adding therapeutics indications, and have you given any further thoughts whether aesthetics and therapeutics should be under the same umbrella? Thanks.

Mark Foley

25:23 Good questions, Annabel, so let me try and work through them. So on the launch timing, we continue to be ready and prepared for launch, when it happens what we’ve said is that, following the resubmission, we would expect to get a new 6 months PDUFA [Indiscernible] given the agency’s indication that reinspection will be required and given sort of where we are with the qualification of the cell bank, we’re certainly hopeful to get our application in as soon as possible and, and sort of with a 6-month clock after that, 2022 is very much a priority for us in terms of getting DAXI approval.

26:05 Shifting over to kind of the aesthetics, therapeutics, FinTech, once we move into therapeutics, does it in any way challenge our ability to continue to focus on these aesthetic initiatives that we’ve laid out? No, we don’t believe so at all. I mean, that’s the FinTech platform, we believe sort of stands on its own and is an important part of our products and services offering in the facial injectable category. The one thing that we’ve long talked about is that there will be price linkage between aesthetic and therapeutic, but that’s the same with all the other competitors that are in that market.

26:40 We think there’s a lot of value that we can unlock on the therapeutic side and so we’re going to continue to try and build a great set of franchise and that, once we file our – our supplemental BLA for cervical dystonia, we’ll start to, you know, build out that therapeutics franchise. Of course, we’re always going to be thoughtful about how we build the right shareholder value long term. Today, we really like where we’re positioned and we think that the volume proposition for long acting neuromodulator, has never been better in terms of the opportunity and I think the recognition in the competitive community that having a long acting neuromodulator is going to be an important asset to have longer-term. So, we’ll continue to evaluate that to what we think makes the most sense but right now we’re very focused on you know kind of the plan as we’ve laid it out.

Annabel Samimy

27:32 Okay. Great. Thank you.

Operator

27:37 Our next question comes from the line of Balaji Prasad with Barclays. You may begin.

Balaji Prasad

27:42 Good evening. Thanks for the questions. A couple of questions from me. Firstly, on the supplemental BLA. Can you help them doesn’t stand what kind of timelines would you need to file it? Assuming DAXI’s approach? There was the question of couple of months or longer one. Two also on the non-GAAP R&D that you guided towards the manufacturing costs being expensed, what kind of inventory is this for the around 6 to 9 months or more than a year? And linked question, what happens to the inventory in case the BLA filing gets further delayed? Hopefully we will reach there, but in case it happens, what would happen to this inventory? Thanks.

Mark Foley

28:31 Yes. This is Mark, I’ll try and take maybe 1 and 3 and then hand it over to Toby for 2 and 4. The sBLA filing for cervical dystonia is teed up to be filed after we get approval for DaxibotulinumtoxinA for injection for glabellar lines, given that we’ve already wrapped up that Phase 3 program, we would expect to submit not too long after the approval of the glabellar lines indication. So we think that is something that we can accomplish in a reasonable timeframe, given sort of the time that we’ve had to prepare that that application.

29:06 And then on the the inventory that we’ve manufactured thus far, we’ve got a 3-year dating on the product that we’ve manufactured. So, we continue to feel like we’re in a good position to be able to leverage and use that inventory. Obviously, depends on timing, but we’ve got a good amount of inventory with debating on it. So we feel we are in a good position there. Toby for number 2?

Toby Schilke

29:34 Yes. Perfect. And just to expand on Mark’s – Mark’s comments on the inventory, we have both drug substance and drug product inventory, and they each have sequential dating on them. So that further extends that. If you were to look – we just filed a form 10K and we break down our R&D expenses a bit further and if you were to look at the back schedule there of the approximately $99 million of non-GAAP R&D expenses in the year 2021, 40% of that was on manufacturing costs. The balance was between OPUL development costs and clinical expenditures. The OPUL development costs will continue to be, we estimate to be flat year-on-year looking into 2022 whereas the clinical expenditures will continue to decline as we’re not executing clinical trials and that will be offset by the manufacturing costs for DAXI that are expensed in the period according to GAAP.

Balaji Prasad

30:39 Thank you, all.

Mark Foley

30:42 Thanks, Balaji.

Operator

30:44 Our next question comes from Tim Lugo from William Blair. You may begin.

Tim Lugo

30:50 Thanks for the question and congrats on what sounds like a productive Type A meeting. Can you talk at all how the sales force has shifted over the past 2 quarters following the CRLA? I know RHA has done well. However, I assumed there may have been some attrition given the late launch?

Dustin Sjuts

31:09 Tim, this is Dustin. Actually our sales force is a really good place. We did not see any kind of break in trend as relates to kind of turnover after the CRL. I think we feel confident that the Revance aesthetics strategies is a portfolio strategy of course anchored by DAXI, but those that have come into the organization, see the value of RHA, they see the value of OPUL, they see the value of how we’re approaching the market or advance aesthetic and are waiting and willing and ready and excited to sell back to the upon approval. So we did not see a kind of significant turn. Of course at the end of the year for all sales organizations, you typically have some kind of turnover. We feel that it’s been – we’ve been within healthy ranges and didn’t see a significant change. We just hosted our team here live in our Nashville global headquarters and training center was the first time our team got to see kind of the – kind of high tech investment we’ve made in toward the injection centers innovate you and others and they left extremely excited and energized to sell RHA, OPUL and are prepared upon DAXI approval.

Tim Lugo

32:16 Good to hear. And maybe could give us a little more granularity on the Q1 Q2 growth expectations. I know coming out of COVID utilization and visits have been very strong across the aesthetics industry. You know for these kind of typically seasonally strong quarters. Can you just, are they going to be kind of turbo boost this year?

Mark Foley

32:39 Hey, Tim. This is Mark. I mean, historically, as Dustin mentioned in the prepared remarks, there is seasonality in the business and normally Q4 to Q1, you’ll see a decline of kind of mid-teens to high teens. Given sort of the growth that we’ve seen in the market. I think that Q4 benefited from that. So on a relative basis, even though Q1 is likely going to be off on a relative basis, Q4 and Q1, that’s probably a reasonable trend that you see. And again, we would expect kind of Q4 to be back up. So obviously, we’re still in the earlier stages of launch and certainly there’s headwinds and tailwinds, obviously, once Daxi is approved, that will be a tailwind. But that’s the normal seasonal trend, even with the growth that we’ve seen in the market.

Tim Lugo

33:27 All right. Thank you.

Operator

33:30 Our next question will come from line of Douglas Tsao from H.C. Wainwright. You may begin.

Douglas Tsao

33:37 Hi, good afternoon. Thanks for taking the questions. Just one clarification. So in terms of the manufacturing runs that have been completed, have you also completed the needed analytical work to characterize those runs? Or is that still – is that part of the work that needs to be done for us in terms of putting together the resubmission? Thank you.

Mark Foley

33:58 Yes, Doug. So we have completed the analytical work associated with those manufacturing batches. So we’ve completed the manufacturing activities related to those batches.

Douglas Tsao

34:10 Okay, great. Thank you so much. Congratulations.

Operator

34:15 Our next question comes line of Serge Belanger from Needham, you may begin.

Unidentified Analyst

34:21 Hi, this is Robin on for Serge. Thanks for taking my question. Just in terms of the OPUL platform, how do you expect it to grow in 2022? Do you see DAXI as a growth driver for the platform when it gets on the market?

Dustin Sjuts

34:36 This is Dustin. I’ll start with the OPUL platform. Yeah, we’re definitely excited about OPUL. As you know, we’re in that next Phase of now having a new platform, a new technology with new features, and building on the foundation of what those features can add in terms of value for our current customers. We’re also focusing this year on migrating those HintMD customers over to the new platform, while also testing out these new features and expanding it. Of course DAXI is have a lot of pent up demand and excitement in the marketplace and will have impact on OPUL, we do see the value of all of these items kind of being a bit delinked has sense of OPUL has a standalone value. RHA has standalone value. DAXI has standalone value, but then the combination can help all 3 in the right account. So we’re excited to continue the progression of OPUL and bringing more value and services to the customer.

Unidentified Analyst

35:33 Great. Thank you.

Operator

35:36 Thank you. And I’m not showing any further questions in the queue. I would like to turn the call back over to Mark for any closing remarks.

Mark Foley

35:44 Thank you, operator. In the coming weeks, we plan to participate in the Cowen health care conference. We welcome your requests for meetings at this event or directly through us. Feel free to reach out to Jessica if you’d like to schedule some time.

35:56 With that I would like to thank all of you for participating in today’s call.

Operator

36:04 This concludes today’s conference call. Thank you for participating. You may now disconnect. Everyone have a great day.



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