Revance Therapeutics Inc (RVNC) 2021 Q4 法說會逐字稿

Welcome to the Revance Therapeutics Fourth Quarter and Full Year 2021 Financial Results and Corporate Update Conference Call. (Operator Instructions) As a reminder, this call is being recorded today, Monday, February 28, 2022.

I will now like to turn the conference call over to Jessica Serra, Head of Investor Relations and ESG for Revance. Please go ahead.

Thank you, Victor. Joining us today on the call for 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 and timing of approval for DaxibotulinumtoxinA for Injection in glabellar lines as well as in therapeutic indications, plans related to the 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. 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.

Also on today's call, we will present both GAAP and non-GAAP financial measures. A reconciliation of non-GAAP to GAAP measures is included in our earnings release.

With that, I will turn the call over to Mark Foley, Chief Executive Officer of Revance. Mark?

Thank you, Jessica. Good afternoon, everyone. Thank you for joining our fourth quarter and full year 2021 financial results conference call.

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 our RHA collection, the latest advancement in the hyaluronic acid dermal filler technology that continues to gain share in the large and growing U.S. filler market. We now have over 3,000 accounts in the U.S. across our dermal filler and fintech platform, which generated over $0.5 billion in gross payment volume for the year. 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 had 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. I would like to take a moment to review how we track on these priorities as well as provide some recent updates.

First, while we did not receive FDA approval for our neuromodulator product as we had anticipated, we made meaningful progress in advancing our regulatory path. Earlier today, we announced that we have successfully manufactured 3 consecutive drug substance lots and 1 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 of our 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, one, the qualification of our new working cell bank; and two, 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. This qualification process was already underway at the time we announced our Type A meeting results, and we are very pleased to have completed the qualification activities in a timely manner. We are now working on our resubmission package, and we'll provide an update once we have resubmitted our BLA.

As we've indicated previously, and based on our Type A meeting, a reinspection of our manufacturing facility will be necessary once our 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 reinspection 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.

As I already addressed 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 III clinical program for cervical dystonia and our Phase II clinical program for adult upper limb spasticity. The completion of our cervical dystonia clinical program marked the second successfully completed Phase III 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. For adult upper limb spasticity indication, we completed the Phase II clinical program and also held a productive end-of-Phase-II meeting with the FDA, which informed the requirements for a Phase III program for this indication.

Given our progress, we are poised to file a supplemental BLA in cervical dystonia following the approval of 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 III program, and we'll continue to evaluate the proper timing for its initiation.

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.

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 a 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 goal for the year, spanning across talent acquisition and internal educational and leadership forms.

Before I turn the call over to Dustin to walk us through our 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 our resubmission, which will bring us one step closer to that goal. Our second priority is to continue to drive top line growth for our products and services, which will continue to be anchored by the RHA collection of dermal fillers to 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 disciplined 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.

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 our performance in the fourth quarter. Dustin?

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 by recording over $70.8 million in total RHA sales. These results were driven by RHA's innovative technology and a strong execution across our Revance aesthetics strategy, which continues to differentiate Revance from other competitors. In the fourth quarter, RHA sales totaled $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 period for aesthetic procedures in each calendar year.

We're excited to build on RHA's 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. The RHA collection now includes 4 distinct formulations that are dynamic, natural and adaptable. And we are currently working with TEOXANE to bring new filler innovations to the market that will enable us to continue to fulfill the unmet needs of both injectors and consumers.

Turning to our fintech platform. An important highlight of 2021 was the launch of OPUL. OPUL is 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 catalog 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.

We began 2021 with a payment processing run rate of 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 through our OPUL and HintMD platforms, net of refunds. 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 will turn the call over to Toby to cover our fourth quarter and full year financials.

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.

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. We have also taken prudent steps to conserve and preserve cash by pausing noncritical hires, deferring a Phase III clinical program for upper limb spasticity 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 Fosun in China. Due to these efforts, our GAAP and non-GAAP operating expenses for the year were 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 cost 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.

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.

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. Finally, Revance's shares of common stock outstanding as of February 17, 2022, were 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.

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 lines 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 of Revance, and I look forward to updating you on our progress in the new year.

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

(Operator Instructions) Our first question confine can Ken Cacciatore from Cowen.

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 put a little bit of a context around? It would be great. And then is there anything else from the 483? Or are we just waiting here on the filing for the working cell bank, the qualification of it?

Yes, Ken. So for the first one, the timing, 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 focus for us. And again, it's more administrative in nature at this point.

In regards to the 483s, previously, we said there were 5 483s. In our responses to the agency items 3 through 5, the agency indicated that our responses appeared sufficient. And then for items 1 and 2 is what we went into the Type A meeting for. And in that Type A meeting, coming out of that, what the FDA wanted to see was the qualification of the new working cell bank with 3 consecutive drug substance and 1 drug product lot. 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.

Our next question will come from the line of Seamus Fernandez from Guggenheim.

This is [Ilana] on for Seamus. Congrats on a quick turnaround with the working cell bank. So we just had 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 around Daxi. Any color on that would be great.

Thanks, [Ilana]. This is Toby Schilke. 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 with 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 can't comment on the specifics, we are taking this as a top priority.

Our next question will come from the line of David Amsellem from Piper Sandler.

So just a couple on RHA. With the approval, I think, of 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 just secondly, just a broader question about the market here. Obviously, you had a good first year, and the product is growing. I know you've said in Europe, the share is 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, David. I'll have Dustin answer the first part of that, and maybe I'll take a crack a little bit in the back part of it.

Sure. So yes, thanks, David. So we're really excited about the approval of RHA Redensity, 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 and 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 mimic the most natural HA, that continues between RHA 2, 3 and 4 and RHA Redensity. So we look at this being a nice addition, and it allows us to continue to kind of talk about our innovation profile.

As it relates to kind of volume, as you'll imagine, lip lines and small, more superficial areas, isn't a high volume utilization of a filler nor is it 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 within the filler space, you see that we'll constantly use this constant stream of innovation to keep being relevant, training new injectors allow us to continue to highlight that technology.

So with that, I'll pass it over to Mark.

Yes. Just pertaining, David, on your comments about market share. What we've previously said that TEOXANE, in the top 5 EU markets, had roughly a 10% share. 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 data we had was sort of $1.1 billion in the U.S. 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 in that it's going to be limited to where TEOXANE is in their top market. And partly because there's fewer competitors in the U.S., and we do think that once our neuromodulator is approved, that is going to allow us to compete certainly more effectively from a bundling standpoint and 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 our neuromodulator is approved, that it's going to give us additional opportunity to continue to drive deeper in these accounts.

Our next question come line of Annabel Samimy from Stifel.

Congratulations on the progress. I suppose you are 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, Revance has been making quite an effort building up the aesthetics platform and working closely with practices, with OPUL in the fintech platform. And it's maybe premature to ask this, but would 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?

Okay. Good questions there, 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-month PDUFA clock given the agency's indication that a 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 sort of with a 6-month clock after that, 2022 is very much a priority for us in terms of getting Daxi approval.

Shifting over to kind of the aesthetics and therapeutics fintech, once we move into therapeutics, does it, in any way, challenge our ability to continue to focus on the aesthetic initiatives that we've laid out. No, we don't believe so at all. I mean 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. We think there's a lot of value that we can unlock on the therapeutics side. And so we're going to continue to try and build a great aesthetic franchise. And that once we file our supplemental BLA for cervical dystonia, we'll start to 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 value proposition for a 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 see what we think makes the most sense. But right now, we're very focused on kind of the plan as we've laid it out.

Our next question will come from the line of Balaji Prasad from Barclays.

A couple of questions from me. Firstly, on the supplemental BLA. Can you help us understand what kind of time lines would you need to file it, assuming Daxi's approved is the question of a 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? Is it around 6 to 9 months or more than a year? And a linked question, what happens to the inventory in case the BLA filing gets further delayed? Hopefully, we don't reach that, but in case it happens, what would happen to those inventory?

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

And then on 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, it depends on timing, but we've got a good amount of inventory with good dating on it, so we feel we're in a good position there.

Toby, for number 2?

Yes, perfect. And just to expand on 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.

We just filed our Form 10-K, 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, 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 cost for Daxi that are expensed in the period according to GAAP.

Our next question will come from the line of Tim Lugo from William Blair.

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 CRL? I know RHA has done well. However, I assume there may have been some attrition given the delayed launch.

Tim, this is Dustin. Actually, our sales force is in a really good place. We did not see any kind of break in trend as it relates to kind of turnover after the CRL. I think we feel confident that the Revance aesthetics strategy 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 for Revance aesthetics and are waiting and willing and ready and excited to sell Daxi upon approval. So we did not see a kind of significant churn.

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 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. It was the first time our team got to see kind of the high-tech investment we've made towards the injection centers, innovate you and others, and they left extremely excited and energized to sell RHA, OPUL and are prepared upon Daxi approval.

Good to hear. And maybe could you 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. For these kind of typically seasonally strong quarters, are they going to be kind of triple-boosted this year?

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 up on a relative basis Q4 to Q1, that's probably a reasonable trend that you see. And then again, we would expect kind of Q4 to be back up. So obviously, we're still in the earlier stages of launch and sort of 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.

Our next question will come from the line of Douglas Tsao from H.C. Wainwright.

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 part of the work that needs to be done in terms of putting together the resubmission?

Doug, so we have completed the analytical work associated with those manufacturing batches. So we've completed the manufacturing activities related to those batches.

Okay. Great. Congratulations.

Our next question will come from the line of Serge Belanger from Needham.

This is Robin on for Serge. 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?

This is Dustin. I'll start with the OPUL platform. Yes, 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 has 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 in the sense that OPUL has a stand-alone value. RHA has stand-alone value. Daxi has a stand-alone value. But then the combination can help all 3 in the right accounts. So we're excited to continue the progression of OPUL and bringing more value and services to the customer.

And I'm not showing any further questions in the queue. I'd like to turn the call back over to Mark for any closing remarks.

Thank you, operator. In the coming weeks, we plan to participate in the Cowen Health Care Conference. We welcome your request for meetings at this event or directly through us. Feel free to reach out to Jessica if you'd like to schedule some time.

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

This concludes today's conference call. Thank you for participating. You may now disconnect. Everyone, have a great day.