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spk00: Welcome to Revan's Therapeutics Third Quarter 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 question during the Q&A session, we would ask for a limit of one question and one follow-up question per person. To ask a question at that time, please press star followed by one on your touchtone phone. If anyone has difficulty hearing the conference call, please press star zero for operator assistance. As a reminder, this call is being recorded today, 9th of November 2021. I would now like to turn the conference call over to Jessica Serra, Head of Investor Relations and ESG of Revance. Please go ahead.
spk04: Thank you, Lori. Joining us on the call today from Revance are Chief Executive Officer Mark Foley, President Dustin Su, Chief Financial Officer Toby Schilke, and Senior Vice President of Clinical Development Roman Mudeo. During this conference call, management will make forward-looking statements, including statements related to the potential approval and timing of approval of doxybotulinum toxin A for injection and roller blinds, and therapeutic indications, our ability to remediate deficiencies identified by the FDA regarding our BLA, a type A meeting with an FDA, financial performance, revenue, and processing volume runway, financial performance and guidance, expected cash runway, our strategic priorities and cash preservation plans, our market and revenue opportunity and the market demand for our products and services, the safety, efficacy, and duration of daxibotulinum toxinase for injection, the potential commercial success and growth of our products and services, the potential benefits of our drug product candidates and technologies, the clinical development of our product candidates, our business strategy, planned operations, commercialization plans, and the aesthetics of therapeutics industry. 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 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. Mark?
spk02: Thank you, Jessica. Good afternoon, everyone, and thanks for joining our third quarter 2021 financial results conference call. Before we cover our performance for the third quarter and review the positive results from our Phase III Aspen OLS study for cervical dystonia, I'd like to provide an update on our VLA for Daxibotulinum Toxin A for injection in glabellar lines. As most of you are aware, we received a CRL from the FDA on October 15, citing their inability to approve our application in its present form due to deficiencies related to the on-site inspection or manufacturing facility. We're obviously very disappointed by the FDA's response and also understand that the continued delay of our BLA has been frustrating for all of our stakeholders. However, I can assure you that the entire revamped team is as determined as ever to get our neuromodulator product approved as soon as possible. We are currently working on preparing a briefing book for a Type A meeting request to gain clarity and alignment on the requirements needed for approval and are incorporating the additional information that was provided by the FDA following our CRL, including our establishment spectrum report, to inform our submission. Given where we are in this process and our pending engagement with the agency, it is inappropriate for us to comment beyond what we've already communicated until we have our Type A meeting. We look forward to providing an update once we have confirmation on our pathway to approval. This is not the first time we've experienced a launch delay. Recall that last year, the commercial rollout of RHA was pushed back five months due to COVID-induced supply chain constraints from our partner, Pioxane SA. Despite the delay in working under the limited parameters of the pandemic, we safely onboarded over 100 sales reps, trained injectors, and delivered a very successful launch that months, and a revenue run rate of over $70 million as of Q3 2021. Looking back, I'm proud of the tremendous progress we've made as an organization over the past two years. First and foremost, in aesthetics, we submitted our BLA for our lead product, Baxibotulinum Toxin A for injection for glabellar lines. We also successfully completed a phase two program for our drug product and upper facial lines. secured the exclusive distribution rights for Teoctane's RHA line of fillers in the U.S., acquired HIN-MD and launched Opal, and built out the strong commercial infrastructure. In therapeutics, we validated the opportunity for our long-acting neuromodulator to treat muscle movement disorders with the successful completion of our Phase III program in the treatment of cervical dystonia and our Phase II clinical trial for upper limb spasticity. Collectively, the muscle movement disorder market opportunity currently stands at $1.2 billion worldwide, and about 70% of that opportunity is in the U.S. The completion of our Aspen program for Daxibotulin toxin apron injection in cervical dystonia marks the company's second successfully executed Phase III program, supporting the differentiated performance profile of our neuromodulator across our clinical trials in aesthetics and therapeutics. All of these milestones position us to create meaningful value within our aesthetics and therapeutics franchises. To put it simply, the opportunity for a long-acting neuromodulator remains strong and continues to be an unmet need for patients and consumers. We continue to believe in the approvability of our product, and based on the CRL, the deficiencies cited were limited to observations made during the age In other words, the CRL is not related to our clinical data package or our product's anticipated label. That said, I'd like to outline our strategic priorities going forward while also announcing some related organizational changes. Our number one strategic priority is to obtain FDA approval for Daxibotulin and Toxin A for injection for gallbladder lines as soon as possible. Number two is to continue to increase our revenue in the $1.2 billion U.S. dermal filler market with our RHA collection. And number three is to expand and cultivate deep and lasting customer relationships through Opal, our fintech platform. In addition to aligning our capital allocation strategy with these priorities, we will also be preserving cash to enhance our financial flexibility. Justin and Toby will cover more on the specifics of our priorities later in the call. In line with our strategic initiatives and in order to optimize their structure for performance, I'm pleased to announce the promotion of Dustin Suess from Chief Commercial Officer to President of Revance. This change allows me to streamline my reports as I assume direct and personal oversight for all aspects of our BLA for Daxibotulinum Toxin A for injection. Further, this change positions the organization to better align resources, facilitate capital allocation efforts, and enhance performance. we have in his leadership he was instrumental in developing revance's commercial strategy integrating pin md building an exceptional team and successfully commercializing our aesthetics portfolio his experience and background will continue to be invaluable to our organization with that let me turn the call over to dustin who will cover our performance for the quarter dustin
spk10: Thank you, Mark. First, let me say by saying that I'm honored to serve as president of Revance. Echo Mark's comments have come a long way over the past two years in laying the foundation for growth, and none of that would have been possible without our team. In my years overseeing commercial operations and interfacing with departments across the organization, I continue to believe that we have the right vision, strategy, and people in place to realize our potential across both aesthetics and therapeutics. The market demand for a long-lasting neuromodulator remains robust, and this is supported by recent clinical programs initiated by our peers to attempt to show extended duration with higher doses of their existing neuromodulator formulations. Our formulation is new and uniquely different from what's available on the market today. It's the only neuromodulator product with a proprietary peptide formulation with clinical data demonstrating a long-duration profile in addition to safety and efficacy. In our Sakura studies, a 40-unit dose of daxibotulinum toxin A for injection showed a median duration of effect of six months and up to nine months for certain patients. Further, our strong clinical data for aesthetic indications in glabella lines, forehead lines, lateral canthal lines, and upper facial lines, as well as therapeutic indications in cervical dystonia and upper lobe spasticity, have all consistently demonstrated a long-duration profile. For these reasons, we believe Daxibotulinum Toxin A for ejection is the most differentiated potential neuromodulator formulation to date. Turning to our results, total RHA revenue for the third quarter was $18.3 million, a 7.4% increase over Q2, despite a slower period. Growth was driven by higher sales from existing accounts, as well as the addition of new accounts. During the quarter, we added over 500 accounts across RHA and our FinTech platform, bringing our total aesthetic accounts to over 2,500. Looking ahead and given the continued strength of the overall market, we expect a seasonally strong Q4 heading into the holiday season. Since its commercial launch one year ago, the RHA collection is proving to be a valuable and differentiated product line. It's the most natural and least modified hyaluronic acid dermal filler on the market today, and we're pleased with the traction we have built thus far. Our commercial team is focused on expanding a prestige customer base for RHA, which in turn will serve directly as the commercial foundation for Dactyl-Botulinum Toxin A for injection once approved. We believe that we can realize significant cross-selling opportunities and operating leverage with our aesthetic franchise over time. Opal, the first relational commerce platform for the aesthetics vertical, adds another exciting piece to our portfolio. We have long believed that the best way to retain and track customers is to be their true partner, to help them build a better practice and stronger consumer loyalty. It puts us to develop a FinTech platform that can not only complement our product offering, but also support practice growth. Opal leverages data from its transactions to help owners build a better relationship with their customers. is a first-of-its-kind technology platform that we believe has the ability to transform patient and physician experiences. In addition to helping us create deep and lasting customer relationships, Opal provides us with the opportunity to participate in the $68 billion U.S. FedEx payment processing market. And now, as a registered payback, the platform can capture more of the credit card processing value chain. Over time, we believe this can represent a substantial revenue opportunity north of $500 billion. During the third quarter, we maintained a payment processing volume run rate of over a half a billion dollars, despite a traditionally slower season. Looking ahead, we believe Opal has a significant runway for growth. We'll be very focused on account penetration, building new features, and completing customer migration from HintMD to Opal. Turning to therapeutics, I'd like to share the positive top-line results from our Phase 3 Aston OLEP study for cervical dystonia. As a reminder, our Phase C program consisted of two trials, the ASPEN-1 and the ASPEN-OLS, or Open Label Safety Study. ASPEN-1 was a pivotal study evaluating efficacy of dactybotulinum toxin A for injection for the treatment of cervical dystonia and was successfully completed in October of 2020. ASPEN-OLS was an open-label, multi-center trial to evaluate the long-term safety of repeat treatment of dacubotulinum toxin A4 injections in adults with cervical dystonia. The study enrolled a total of 357 subjects, of which approximately 90% rolled over from the ASPEN-1 study. Subjects could receive up to four treatments over a 52-week period, and the doses evaluated included 125, 200, 250, and 300 units. We are pleased to report that the study demonstrated doxibotulinum toxin A for injection was found to be generally safe and well-tolerated, as well as effective across all doses with repeat treatment. The most common treatment-related adverse events on a per-treatment basis were muscular weakness at 4.9%, dysphagia at 4.2%, and injection site pain at 2.7%. There were no serious treatment-related adverse events or dose-dependent increases in adverse events. We are pleased to see that the efficacy data in the Aspen OLS is consistent with the efficacy results and duration profile observed in the Aspen 1 study. In the Aspen OLS study, the median duration of effect, as defined by the time-to-reach target twister score, ranged from 19.9 weeks to 26 weeks across doses within the evaluable treatment cycles. Comparatively, the median duration of effect observed in the Aspen 1 study was 20 to 24 weeks for 250 units and 125 units. Given the safety, efficacy, and long-duration profile, we continue to believe that the dactybotulinum toxin A for injection can be a promising new treatment option for adults with this condition. In particular, we believe that compelling dose-ranging data from the study can help physicians optimize treatment plans for patients, especially since the dosing strategy and treatment of effect can vary with each patient. Aspen III Clinical Program is our second successfully completed Phase III program for Daxiboxamin and Toxin A for Injection across two different treatment categories. We'll assess the best way to advance our opportunity in cervical dystonia and upper limb spasticity following clarity from the FDA on the approval path for VLA for Govella Y. With that, I'll turn the call over to Toby to cover our third quarter financials. Thanks, Dustin.
spk08: Total revenue was $19.7 million for the third quarter, which included $18.3 million from our RHA collection, $1.1 million from our partnership with Beatrice on the biosimilar to Botox, and $0.3 million from our FinTech platform. Turning to our operating expenses. Selling, general, and administrative expenses for the third quarter were $52.8 million. This primarily included sales and marketing expenses related to RHA and pre-commercial activities for dactybotulinum toxinase for injection. SG&A expenses included depreciation, amortization, and stock-based compensation. Excluding these expenses, non-GAAP SG&A expenses were $45.1 million. Research and development expenses were $30.1 million for the third quarter, reflecting costs related to clinical trials, regulatory support for ongoing VLA, pre-commercial manufacturing and quality activities, and FinTech platform development. and stock-based compensation. Excluding these expenses, non-GAAP R&D expenses were $25.7 million. Cash, cash equivalents, and short-term investments as of September 30, 2021, were $273.7 million. Revances shares of common stock outstanding as of October 28, 2021, 76.8 million fully diluted shares, excluding the impact of convertible debt. Now I'd like to review our capital allocation priorities and the prudent measures we are taking to extend our cash runway. As Mark and Dustin mentioned, our investments at this time are focused on obtaining FDA approval for Daxibotulinum Toxin A for injection, driving greater adoption of RHA, through Oval. We believe this will maintain our strong commercial momentum and enhance our financial flexibility. The proactive steps we are taking to preserve cash include, but are not limited to, pausing non-critical hires, deferring a Phase III clinical program for upper limb spasticity, as well as other therapeutic pipeline activities, and pausing international regulatory and commercial with the exception of our collaboration with Bosun in China. Due to the CRL I received from the FDA, we are withdrawing our previously stated cash guidance of cash into 2024, which assumed FDA approval of Daxibotulinum Toxin A for injection in 2021. Following our Type A meeting with the agency and upon gaining clarity on our approval pathway, we plan to provide an updated cash guidance and our 2022 GAAP and non-GAAP operating expense guidance. I'd like to emphasize that while our measures to preserve cash are important, we also expect them to be temporary. We remain committed to building our business long-term, and particularly our therapeutics franchise, given the strong clinical data we have accumulated underscoring the differentiated performance profile of Daxibotulinum Toxin A for injection. And with that, I'll turn the call back over to Mark. Thank you, Toby.
spk02: In closing, we executed on our commercial strategy and delivered a strong Q3 in our base business despite the impact of seasonality. We're also very pleased to advance our therapeutic potential in treating cervical dystonia to the completion of our Phase III Aspen clinical program, representing a market opportunity north of $300 million in the U.S. In the near term, obtaining FDA approval is our top priority. As we speak, we are preparing our briefing book for the Type A meeting request and will provide an update once we have confirmation on our path forward. With that, I will now open the call up for questions. Operator?
spk00: Thank you. And as a reminder, to ask a question, you will need to press star 1 on your telephone. Again, that is star 1. Our first question is from Ken Cacciatore of Cohen & Company. Your line is open.
spk09: Hey, Mark and team. Question around the CRL. I know when you received it, there was a little bit of lack of clarity into all the different things that were being asked for. I know you now indicated you have the established inspection report. So wondering if that provided you any more clarity. Does it provide any more comfort or discomfort after you've now seen that? And then secondly, can you just talk about the folks that you've been working with both internally and externally, consulting with you that have expertise here? Have you changed that at all? Are there folks you've brought in, or is it the same folks and you feel fairly comfortable with who's helping you navigate through the process? Thanks so much.
spk02: Thanks, Ken. So, first on the CRL, you know, as we mentioned at the time that we received the CRL, there was no clarity exactly on which of our responses to the 483s were going to be sufficient or not sufficient. And we indicated at that time that prior to requesting a type A meeting, we're hoping to gain additional clarity from the agency before filing the type A meeting request. Subsequently, as we commented the EIR and additional feedback from the agency, which is going to guide, you know, sort of the submission of the Type A meeting request. We continue to feel really good about the responses that we provided to the 483. more of those responses. At this point, we're not going to get into sort of surmising anything. We're getting into sort of a play-by-play with the agency. We do feel like the Type A meeting is the point where we plan to get more clarity from the agency, and we'll provide more context and color at that time. On the consultant side of it, you know, we feel, first off, really good with the responses that we provided to the 483s. We were frankly surprised that we didn't have any communication from the agency a However, in the sort of the importance this additional information that's allowed us to refine our type A meeting request.
spk09: Thanks, Mark. Okay, continue. Good luck in the process. Thank you.
spk00: And our next question is from David Amselen of Piper Sandler. Your line is open.
spk03: Hey, thanks. So, just a couple on the CRL and the path forward here. So, you know, the FDA action was essentially delayed for almost a year due to pandemic-related constraints. So I wanted to ask you, to the extent that you can answer this, assuming the agency is going to have to go back into the facility and do an inspection, does the pandemic in any way factor into your calculation regarding turnaround time? And how should we think about that? And maybe do you have any sort of feedback from the FDA as to what their constraints are right now, since that has been a consideration in the past? So that's number one. And then number two is, you know, with these kind of processes with consultants, internal consultants, external consultants, et cetera, do you have a sense of what kind of spend you might need or additional spend, if you will, to get to a point where you have all your ducks in a row in terms of manufacturing? And maybe you don't know the answer to that. Maybe that's post-type A meeting. But can you just help us understand, you know, just at least qualitatively what your thoughts are there? Thanks.
spk02: Sure. So first, David, on your question around the CRL and clarity and, you know, even internally, you know, we're trying to make sure that we're being as transparent as we can. I think given where we are, what we want to make sure is that when we do communicate, we communicate with certainty and clarity. And so right now we'd be speculating further as to whether or not there'd be pandemic-related issues in terms of timing. Again, we believe that the best way to get clarity on this is through a type A meeting, take. On the consultant side of it, in terms of spend and manufacturing and everything else, we talked earlier about the priorities that we've laid out. It's getting approval. It's delivering on the RHA revenue and continuing to drive adoption of the Opal platform while being judicious with our spend. We believe we've got the right plan in place, and we'll resource all of those appropriately to make sure that we continue to not lose momentum and deliver on those key priorities for the company.
spk03: Okay. Thank you. Thank you.
spk00: And our next question is from Simas Fernandez of Guggenheim. Your line is open.
spk06: Oh, great. Thanks for the question. So just a couple of quick ones. I'll move beyond the CRL. But wanted to just get a sense of how the trajectory for the RHA fillers you feel is likely to continue into the fourth quarter and into next year. It sounds like there's high conviction that that continued growth will be there. But it was our understanding that DACSI was also sort of a forward use opportunity for some of your key positions. So is the goal next year to really broaden out the RHA account number substantially beyond sort of the 2,500, or is it really to increase the penetration of the existing practices I know that I'm sure you're going to increase penetration of the existing practices as part of the standard, but the question is, does the pullback on spend limit your ability to expand to new accounts in any way, shape, or form? And I have a second question after that.
spk02: Sure. So maybe I'll jump in and maybe let Dustin add a little context and color as well. So first off, in terms of the trajectory, let me start by saying we're incredibly pleased with how well the RHA launch has gone. I mean, in a short period of time, we've validated the strategy. We've generated really good revenue growth, and I think it's a testament to the strategy and the execution of our commercial team that's out there and the quality of the RHA product line. We're also still looking forward to getting RHA 1 approved, which we also think will help going in Q3, so that's all good. And then if you look at sort of the headwinds and the tailwinds, on the tailwind side of it, you know, you've got ongoing focus on the RHA product line, which would have competed for a little bit of time, you know, with the launch of our neuromodulator. So we'll continue to drive that. As you mentioned, Seamus, you know, the number of accounts, we've talked about sort of going after the prestige category in the market, which is the top third, which is roughly, you know, 15,000 or 2,500 along that journey, adding roughly 500 accounts per quarter. So we do think that there's still room to drive ongoing penetration there. Countering that a little bit is obviously, we know that having a neuromodulator in our bag will also help unlock opportunity in some accounts. So again, tailwinds, we've got focus, we've got new accounts that we can open, and then headwinds,
spk10: want to add anything to that just a couple things i think the strategy for a ramp aesthetics focus on the account and not on driving consumers loyalty kind of beyond the agnostic of an account has really resonated that resonates well with rha we get some lists on that i want to address the spin spin question as well we feel very confident that when we laid out those strategic priorities we're able to make adjustments and resources to ensure that we're not choking the spin of the rha and investing in those things that have the highest return. It's a very good growing market for the dermal fillers, and we think that we'll continue to be able to drive growth. While it'd be great to have Daxi right now, we feel like we can utilize this time to focus on RHA, and the demand for Daxi is there. I get countless calls for doctors already asking when it's coming, when it's coming, as you can imagine. So we feel like we could use that momentum around the romance aesthetic strategy with Opal and RHA to get us started and grow both new accounts as well as our penetration.
spk06: Great. And then just in terms of the plan filing for CD that I think we were anticipating this year, you know, how should we think about the CRL the manufacturing discussion points, and when you'll be able to provide us with a detailed update, you know, on the overall sort of filing strategy in 2023. Will that come alongside the type A, you know, the post-type A meeting updates, or will that come, you know, perhaps at a later point in time?
spk02: Yes, so just to reset sort of what we communicated on CD was to complete sort of the OLS program in 21, file in 22, approval in 23. And now that we've completed the overall phase three program, we are certainly in a position to be able to file that. Our strategy all along was to However, given the linkage between the SBLA filing and the approval of our glabellar lines indication, I think the most appropriate time to give an update on that will again be after the Type A meeting where we'll have more clarity and visibility.
spk06: Great. And then just one final question. Any visibility on the actual timing or kind of the regulatory timing of the Type A meeting itself? It was our understanding that it would be, you know, probably take two weeks to request and then 30 days post that to actually get the meeting. But, you know, we're hearing about some delays at FDA, a lot of backlog. Just wanted to see if there was any, you know, sort of a general clarity on that that you might be able to provide. Just even the outside possibility that this could be kind of an end of Q1. meeting is something that we're getting questions from investors on. Thanks.
spk02: Sure. Yeah, I'll go back to kind of Ken's early question. Again, you know, what we indicated previously when we received the CRL, given that there wasn't any specifics in the CRL itself, we were hoping to get a little bit more clarity, which we now have to sort of refine, you know, the meeting request, you know, binder that we put together. So we think we've got that clarity to guide that filing. And then, you know, we know what the statutory timelines are. Typically, it's 14 days for them to review and make a decision on granting a type A meeting or not. And then that gets scheduled within 30 days. Certainly with the pandemic, I'm sure there are scenarios where that could get pushed out. We're hopeful that that will stay on track and on target. And again, our plan is to communicate, you know, with clarity once we've had the type A meeting.
spk06: Great. Thanks, guys.
spk00: And our next question is from Annabelle Samimi of Stiefel. Your line is open.
spk05: Good afternoon, everyone. This is Nick Rubino on for Annabelle. Thanks for taking our questions, and congratulations, Dustin. So you mentioned the double-dosing regimens from competitors. What have you seen in the marketplace in terms of trends towards practices utilizing this method? And do you see the economics around this regimen potentially infringing on DAX's value prop? And then just a quick one. Did the end of phase two meeting change anything about how you're thinking about the Juniper study going forward? I know it's kind of on the back burner for now, but just any thoughts around that meeting? Thank you. Sure.
spk02: So first on, you know, double dosing, you know, if anything, I think we look at it as sort of further credentialing. I think if you go back in time, there was sort of a long narrative that there really wasn't a need and patients didn't want it. But I think pretty quickly now it's coming to a point where people recognize that there's a real need in the market. of evaluating performance. So, you know, until there's true phase three data out there that looks at it, you know, we continue to think that in the absence of a differentiated formulation, it's going to be hard to match the duration profile matched with the safety and efficacy of our product. So, we continue to feel like there's a huge opportunity on that. You mentioned the economics. Certainly, if you start getting I think that's a little bit of a TBD. On the End of Phase II ULF program, we were very encouraged by the feedback that we received from the agency in that End of Phase II meeting. So we now have clarity around the Phase III program that will be needed to move that forward and to ultimately seek approval for that indication. As Toby mentioned in his remarks, the approval of the DLA, you know, the ongoing sort of adoption of the RHA line of filler products and, you know, getting Opal out into the marketplace. We're going to pause sort of the phase three program. But, you know, again, this is not an if, it's a when. And we will look to sort of resume activities around our therapeutics pipeline, you know, once we feel that we're in a position to transition. our phase three program there.
spk05: Great. Thank you. And just a quick clarification. Are you seeing the double dosing as far as actually being used in the market? Are you seeing trends of that increasing? Like are more people doing that now versus before? Or is it more just, you know, it's generating clinical buzz as opposed to commercial use?
spk10: Hey, Nick, this is Dustin. You know, we actually haven't seen it really resonating. These aren't clinical trials. A lot of these have been IITs and obviously other Phase 4s. So the rigor of those is not necessarily the same as the Phase 3 program with stringent endpoints. I think it's a novel concept that people are trying to do as it relates to kind of data generation. The practicality is I don't believe any manufacturer has cut their price in half. If they haven't done that, the value for the practitioner to try to do that for a slightly increased duration profile is one that doesn't seem to resonate. And also, there's never really been long-term safety on increasing the neuromodulator dosing to try to drive that efficacy. So, to date, no, we have not seen that resonate outside of a few publications.
spk05: Perfect. Thank you very much.
spk00: And our next question is from Vemo Divan of Mizuho. Your line is open.
spk01: Great. Thanks so much for taking the questions and the details you provided so far. So maybe one around DAXI. And just in terms of the EIR, can you give any clarity around that specifically? You know, was it specified as a voluntary action indicated or official action indicator or anything sort of more in terms of what you saw there? And then maybe just a couple sort of quick kind of clarifications from, I guess, for Toby, just as you sort of think about your cash position and some of the changes you're making. Can you just talk about how that impacts the Vietris collaboration in terms of spend there? And then just in terms of sort of SG&A R&D, sort of, I don't know if you can provide any sort of run rate that we should think about, you know, for fourth quarter or maybe, you know, for the first couple quarters of next year? as we update our models, just in terms of kind of how that might be impacted by these efforts you're making? Thank you.
spk02: Mark, I'll hit the first one, and then let Toby hit your second question. So, you know, in terms of more clarity on the EIR, again, you know, I completely understand the desire for, you know, more information, but, you know, we, again, I think you back to, we felt really good about the responses that we provided to the observations in the 4H3. We believe that, you know, we've got the additional information going to be commenting on additional specifics until we get the Type A meeting with the agency to make sure that, again, we've got full clarity on what's going to be needed going forward.
spk08: And then with regard to your question around Beatrice, again, we continue to believe in that collaboration and that partnership that we have. We had a successful Type 2 meeting that provided clarity on what's needed to conduct a successful plantel trial for the biosimilar to Botox. So we will continue to invest alongside Beatrice. Recall that that R&D collaboration is the 50-50 cost share going forward. Then your third question was on the mix of fourth quarter spend and sort of projected runway rates going forward for OPEX. I think there will be a little bit of puts and takes as we approach fourth quarter, you know, sort of where we are for the full year. Just given that there will still be, we had anticipated a little bit more capitalization of sort of the manufacturing costs for the inventory production of DACSI. However, that would be offset by less SG&A on sort of the launch and the Perry launch for DACSI, if that makes sense. And then, you know, the cash preservation initiatives that we already have underway to extend our cash runway, You know, just to guide you to our Form 10-Q that we filed today, where we assessed that operating plan that we described in a prepared remarks against sort of our current financial resources. And in there, we concluded we had sufficient balance sheet resources to fund our operations for at least 12 months filing the Form 10-Q.
spk01: Okay. Thank you. Thanks.
spk00: And again, as a reminder, to ask a question, you will need to press star 1 on your telephone. We have a question from Tim Lugo of William Blair. Your line is open.
spk07: Thanks for taking the question. Now that you've had RHA out there for a year, I know we're all hoping for a relatively quick resolution with the agency around DACSI, but how are you game planning 2022 if Daxi is not on the market for the whole year, and how should the street kind of expect to see RHA and I guess also Opal sequentially grow throughout the next few quarters, or that to the extent of we're just waiting for Daxi and that halo effect that will come when Daxi is approved?
spk02: Yeah, Tim, so first off on RHA, if you look at our commercial infrastructure and the people that we have in place, the strategy, the dollars that we're supporting that brand, and the commentary we made earlier about the fact that we're still largely or pretty thinly penetrated into our target market, the fact that our team is very focused on it, the fact that we expect RHA1 to come online here. You know, we continue to like how we're positioned in the market and the ability to continue to drive penetration. And the same with Opal, too. We just recently, you know, integrated the PayFact functionality in there, which will start to allow us to turn on additional premature to speculate sort of, you know, what that runway looks like independent of our neuromodulator. And that's why I think once we have clarity from the agency around the type A, we'll be I don't know, Dustin, if you want to add anything on that.
spk10: I think it's still really good. This market is continuing to grow. We've been purposeful about building a standing value proposition for the unique characteristics of RHA. You didn't see us coming out with pricing programs, coupons, and others that are artificially driving demand based off of price. People are choosing to buy RHA because the technology is different than what they have in their practices today, and our strategy for anesthetics is different than what they're getting from other manufacturers. That doesn't change without Daxi. Of course, we want Daxi, and we look forward to having that as quickly as possible. We feel very good about the strength of RHA and Opal, agnostic to Daxi proof.
spk07: That's great to hear. And is there any update with your partnership with Fiat? And I know that they took stock in the deal, and obviously the stock's been extremely weak since the CRL. Is there, you know, what kind of, I guess, what's the general status of the relationship and is there, you know, are there any kind of triggers around share price that, you know, could be, that could impact the relationship?
spk02: Yes and no. You know, the upfront sort of stock grant that we made was, you know, part of the overall distribution deal that we had, which was a 10-year deal in the U.S. with the ability to extend it for two one-year periods up to a total of 12. there are minimums in there around sort of revenue, uh, and spend, uh, but they've been a great partner. Um, we continue to feel really good about how we're performing in the marketplace. So, you know, if anything, you know, given the delay in our neuromodulator, we're able to focus more resources and focus on building the brand, which over time we think will benefit us in terms of a larger account base. Once we ultimately get our neuromodulator approved, but now the relationship continues to be really strong. Um, and, uh, you know, from a relationship perspective.
spk07: Okay. Great to hear. Thank you for the question.
spk00: Thank you. And there are no further questions at this time. I will now turn the call over back to Mark Foley, Chief Executive Officer, for his closing remarks.
spk02: Thank you, Operator. In the coming months, we plan to virtually attend the Stiefel and Piper Sandler Healthcare Conferences. We welcome your requests for meetings at these events 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.
spk00: And this concludes today's conference call. Thank you for participating. You may now disconnect.
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