Strongbridge Biopharma plc
Q4 2020 Earnings Call Transcript

Published: 3 Mar 2021

[Operator:]

Ladies and gentlemen, thank you for standing by and welcome to the Strongbridge Biopharma Plc Corporate Update and Fourth Quarter 2020 Earnings Conference Call. At this time, all participants are in a listen only mode. After the speakers' presentation there will be a question-and-answer session. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your host, Lindsay Rocco, Elixir Health, Public Relations. Please go ahead.

[Lindsay Rocco:]

Thank you and good afternoon, everyone. We are pleased that you could join us today for Strongbridge Biopharma’s fourth quarter and full year 2020 results and corporate update conference call. Joining me from Strongbridge this morning are John Johnson, Chief Executive Officer; Scott Wilhoit, Chief Commercial Officer; Rich Kollender, President and Chief Financial Officer; and Dr. Fred Cohen, Chief Medical Officer. Before we begin, I would like to remind you that during this call, the company will be making forward-looking statements that are subject to risks and uncertainties that may cause actual results to differ from the results discussed in the forward-looking statements. Reference to these risks and uncertainties are made in today’s press release and disclosed in detail in the company’s periodic and current event filings with the U.S. Securities and Exchange Commission. I will now turn the call over to John Johnson.

[John Johnson:]

Thanks, Lindsay and thank you for joining us this morning. Before we begin, I'd like to take a moment to welcome Rich Kollender to the call under his newly expanded role as President and Chief Financial Officer. As many of you know, Rich has been serving as Chief Operating Officer of Strongbridge since September 2019 and previously served on Strongbridge's Board of Directors and as Chairman of our Audit Committee. Rich is an accomplished industry veteran with significant leadership, finance and operational experience and we are confident that in this expanded role, he is well positioned to help us further strengthen our footprint as a successful rare disease organization. We would also like to thank Rob Lutz for his contributions to Strongbridge and we wish him well for his new opportunity outside the company. 2020 was a year of exceptional execution for Strongbridge. I want to express how proud I am of the many significant accomplishments that the Strongbridge team achieved throughout the year. Despite the extraordinary circumstances brought on by the global COVID-19 pandemic, Strongbridge achieved strong revenue growth for KEVEYIS, while also making significant progress in our clinical development program for RECORLEV in the endogenous Cushing's syndrome. I am extremely pleased to report that yesterday we announced the submission of the RECORLEV New Drug Application to the U.S. Food and Drug Administration, which is based upon the previously reported positive and statistically significant results of the Phase 3 SONICS and LOGICS trials. The submission of the NDA represents not only a significant milestone for Strongbridge, but for the Cushing's syndrome community as a whole.

[Scott Wilhoit:]

Thank you, John. Good morning everyone and thanks for joining us. As John mentioned, we are very pleased with KEVEYIS performance in the fourth quarter and overall in 2020 and are confident that we can continue to grow the brand in 2021 and beyond. As mentioned on previous calls, early in the second quarter, we quickly developed and implemented a comprehensive COVID-19 mitigation plan. The core elements of the plan consisted of maintaining and growing our active base of patients and generating new referrals by creating new and innovative ways to interact with healthcare providers and patients. We believe that our rapid response to the pandemic and ongoing healthcare provider and patient execution contributed to both a steady flow of referrals and new patient starts for KEVEYIS and improvement in conversion and retention rates. We hope that increased vaccination rates and more normal access for patients to their primary care physicians will allow the patients suffering from this debilitating disease to be more readily diagnosed and treated in the future. Moving on to RECORLEV, as John mentioned, we are excited to have submitted our NDA to the FDA and given our enthusiasm for RECORLEV, we've aggressively moved ahead with launch preparedness activities. Some of these include activities -- include ongoing cultivation of key leader and patient advocacy relationships, development of record of brand positioning, field foresight and optimization, and market access activities, as well as ongoing healthcare providers and patient market research. We believe that we are well positioned for successful launch, given both the current rare disease focused commercial infrastructure, which has been purposefully built and our significant experience in launching both KEVEYIS and MACRILEN. As we move closer to RECORLEV launch throughout the coming year, we will plan to provide more in-depth updates on our progress and on the marketplace we expect to be competing in. With that, I'll turn the call over to Rich for review of our financials before we open up the call for questions. Rich?

[Richard Kollender:]

Thank you, Scott. This morning we filed our 10-K and also issued a press release containing details of our financial results for the fourth quarter of 2020 and for the full year 2020. Rather than wade through all of those details, my comments will focus on some key financial results and guidance. 2020 was a very strong financial year for our company. For the full year of 2020 net revenues from sales of KEVEYIS increased $9 million or 41.5% from $21.7 million for the 12 months ended December 31, 2019 to $30.7 million for the 12 months ended December 31, 2020. The company recorded cost of sales of $2.2 million for the 12 months ended December 31, 2020, compared to cost of sales of $3.8 million for the same period in 2019. Cost of sales decreased due to changes in the assumptions underlying the allocation between the purchase price of our inventory and our supply agreement. Out gross margins were 93% for 12 months ended December 31, 2020 compared to gross margins of 82% for the same period of 2019. Selling, general and administrative expenses were $40.9 million for the twelve months ended December 31, 2020, compared to $49.1 million for the same period in 2019. The decrease during the current period was due to reduced personnel costs from headcount reductions, reduced spending due to COVID-19 travel restrictions, and lower third-party expenses. Additionally, the prior period had $3.2 million in one-time charges for severance expense. Research and development expenses were $25.8 million for the twelve months ended December 31, 2020, compared to $30.9 million for the same period in 2019. The spending reduction was primarily due to decreases in product development and supporting activities resulting from the Phase 3 clinical program for RECORLEV. Turning to 2021, this morning we also confirmed our full year 2021 revenue guidance for KEVEYIS of $34 million to $36 million. Regarding operating expenses, although we don’t provide specific guidance, we expect that our R&D expenses will be lower in 2021 as compared with 2020 as the expenses for the LOGICS trial reduce following the end of that study. Regarding SG&A, we expect expenses will be modestly higher in 2021 versus 2020 as we invest in preparations for the launch of RECORLEV while also maintaining our SG&A investment in growing KEVEYIS. We ended 2020 with approximately $87.5 million in cash. Importantly, we expect to have more than one year's worth of cash at the time of the potential RECORLEV FDA approval.

[Operator:]

Thank you. Our first question comes from a line of Chris Howerton with Jefferies. Your line is now open.

[Chris Howerton:]

Hey, good morning, and congratulations on getting the submission done. That's obviously a really big milestone for the company, so congratulations especially to Fred and the team there.

[Fredric Cohen:]

Hey, thanks Chris, I appreciate it.

[Chris Howerton:]

Awesome. All right, well maybe just a couple quick ones from me. I think, obviously very pleased to see the strong performance of KEVEYIS, but if we were to think about, what's going on in the Cushing's syndrome landscape right now, I would think that ISTURISA is probably the most comparable launch to what RECORLEV might experience. So I guess, Scott, how do you see that as a benchmark and how do you expect to be able to perform against it?

[Scott Wilhoit:]

Yes Chris, happy to take that. You're right. I mean it's recent and relevant. First of all, as we said on previous calls, we're rooting for them because the unmet need in Cushing's syndrome and the patients in the category are underserved. So we think they're off to a pretty good start, given they launched, kind of in the middle, if you will, of this pandemic last year, in the May timeframe and you probably saw their disclosures in their recent announcements. So we think they're off to a good start, so we're rooting for them. In terms of how we think about the market, as you know, we did a pretty comprehensive market assessment, included ISTURISA in that competitive assessment, and RECORLEV in its profile and the data that Fred's team has generated through our Phase 3 programs, it really -- the profile was competitive across the category, including against ISTURISA. We believe there's opportunity and today in particular, in a significant portion of the population that's women and if you know that 75% to 80% of the population. So some of the side effect profiles associated with products on the market, including ISTURISA, are potentially problematic there and we think that the profile for RECORLEV may be very attractive for that segment. But as I said, the product, RECORLEV, it was very compelling in terms of its performance across the category, not only ISTURISA, but against ketoconazole as well. So hopefully that provides you some color.

[Chris Howerton:]

Yes, yes, that's very helpful. I'm sorry, go ahead John, sorry.

[John Johnson:]

Yes and I was just going to add Chris that, you know it's a really a solid launch given the pandemic, and I think what we were encouraged by was what we've heard anecdotally from payers and from the field, and from physicians frankly, that they're getting reimbursed. And that reimbursement is coming in many cases from generic products. And I think it goes to show that rare disease patients continue to get some degree of priority access when their physician intervenes. And so, we've been pleased with that, and hats off to them for having a solid start in the middle of the pandemic and just heading into the summer. So let's see what happens as patients get more into the office and as the vaccine continues to roll out, but good start and certainly supports our hypothesis.

[Chris Howerton:]

Yes, okay, very good. And Scott, maybe if I could maybe just make a quick clarifying question on one of the things you said, with respect to the side effect profile, particularly in women, would you provide a little more color on this specifically what you mean there and maybe like what degree of problem that is?

[Scott Wilhoit:]

Yes, happy to Chris. So you know in our research we talked to physicians, just to remind everyone, we had a quantitative study with 153 endocrinologists, and we had them look at the top attributes, and one of those is the certain of the side effects that they have to deal with certain products and in particular the androgenic effects of products and the impact on women that causes, so excessive hair growth, acne, oily skin, those types of things ranked fairly high in terms of the unmet need that physicians face when they're prescribing products. And certainly, our product tested very, very well in that regard. And so we think that that's a significant opportunity based on our clinical profile, and since that impacts women that's a substantial portion of the market. So that bared out in our research and we'll continue to do some more research there, but we think that's a significant opportunity for our product and the data that Fred's team has generated.

[Chris Howerton:]

Got it, okay, that's great. Thanks, Scott. All right, and then maybe just another couple of quick ones I think probably related to some degree. John, you know like what any updates for the plans for Veldoreotide and anything else we should be thinking about with respect to future business development plans?

[John Johnson:]

Well, you know, we're not going to speak Chris to future BDA at this point. All I would say is that Rich and his team are actively screening potential opportunities. As it relates to Veldoreotide, you know, Fred maybe you want to give us some commentary on that?

[Fredric Cohen:]

Yes, so we have been actively studying Veldoreotide. At this time, we're still looking at our options, what we want to do with that and in the future I expect Rich or I will give you an update on that Chris. Sorry, sorry for no update today.

[Chris Howerton:]

No well, that's fine. All right, well I think that's it for now and I appreciate you guys taking the questions.

[Fredric Cohen:]

Thanks, Chris.

[John Johnson:]

Thanks, Chris.

[Operator:]

Thank you. Our next question comes from the line of Hartaj Singh with Oppenheimer & Company. Your line is now open.

[Hartaj Singh:]

Great, thank you for the questions and also kudos on all the good work everyone. Just a couple of quick ones, one is the poster presentation at ENDO, not to front run it, but can you just give us an idea of what to look for, what are the things to expect, also how it relates relative to the various presentations you've done on SONICS with the proceeding trial? That's number one. And then number two, can you actually updates on why KEVEYIS is doing better? I think the fact that you're able to increase sales year-on-year during a pandemic was pretty impressive. If there's something else just fundamentally happening in the market, is there a structural shift to maybe more awareness among physicians, so that more patients are potentially coming in to be treated or being better screened, et cetera? Thank you for the question.

[John Johnson:]

Hey thanks, Hartaj. Fred why don't you start with the ENDO question and then we'll go to Scott?

[Fredric Cohen:]

Sure. So we're happy to be able to share the results of LOGICS with the scientific community for the first time, so although we have presented the key results to an investor audience, this is our first opportunity with a science audience. And basically, it's going to be largely what we've shared in terms of the top-line, but more just more detail around that, more detail around the efficacy, as well as detail around some of the kind of safety analyses that we've done, just basically fleshing out those data. We're not going to be presenting a bunch of sort of exploratory or secondary analysis, it's really focused on the main study results.

[Hartaj Singh:]

Great, thanks Fred.

[John Johnson:]

And Scott?

[Scott Wilhoit:]

Sure. Yes, good question. You know, I think a couple of things. One is that we're the only company out there that's actively promoting supporting the PPP community and have been now for several years. So I think that over time definitely had some impact. Our relationship with efficacy has been a very positive relationship, and as you know in rare disease, efficacy plays a very strong role in supporting patients. And in part to your question about increasing awareness and education, it's an excellent conduit for that. I think we have just the fundamentals, whether it's within the pandemic or outside of it, our ability to identify physicians who may have patients fairly rapidly and qualify them if you will to determine if this patient may be a candidate for KEVEYIS. We've improved those, that that area of our business, which enables us to get high quality referrals, potentially a little more throughput, and then we've -- we consistently work on our patient services with our patient services team to convert these patients to drug, if their physician writes prescription, as quickly as we can and work with the patient and the doctor to maintain them on therapy. So I think, the model that we've developed, which as we've talked about, is very leverageable for RECORLEV is, all of those things, I think have helped us continue to grow the market. So hopefully, that provides you a little bit of insight.

[Hartaj Singh:]

Yes, that's very helpful. I just have one other question as a follow up. I know that KEVEYIS, originally you got it from Taro, I believe a generics company, you're working on the IP extension, could you just maybe talk a little bit about the different scenarios? Assuming you don't get IP and generic companies really want to enter again, into this market, they sort I mean give it too Strongbridge earlier, or if you did get IP, how would that potentially change anything? And again, thank you for the questions.

[John Johnson:]

Thanks, Hartaj. Now look, it's a great question. And if you look at rare disease drugs, I mean the fact that they're given through specialty pharmacy, and there's a lot of hand holding that needs to take place to reimbursement and to have a hub to properly serve those patients, is an important factor. When you look at the market as a whole, you have about 50% of the drugs and it had some type of generic entry with various levels of success and half haven't. We can't speculate on what generic companies will or won't do, but clearly with our model, in the PPP market, there's not a group of patients that go to centers of excellence, that you can contract with 10 centers and go ahead and pull the business from there. This is really a business where diagnosis still remains challenging. It's spread out throughout the community. So it's not an easily accessible population to try to bring a generic into. And as I said, I'm not going to speculate whether they will come in or they won't come in. We feel very confident in our IP and certainly the guidance we've been given from outside counsel about future IP. All that being said, this is a patient population that we want to serve, that isn't easy to serve and only time will tell, but I'm really proud personally of the work that Scott and his team has done with the community, and how we've brought this disease more to light. We have more work to do there. And assuming that we have extended IP, we would invest more heavily in continuing to develop that market versus the uncertainty of a generic. But, all that being said, we're doing really good work there today. We've kept patients out of the hospital as they've told us during COVID, and especially out of the emergency rooms is the feedback we've received. And as such, we're proud of what we've done, and we're going to continue our mission to serve those patients.

[Hartaj Singh:]

Great, thank you, John.

[Operator:]

Thank you. Our next question comes from the line of Annabel Samimy with Stifel. The line is now open.

[Annabel Samimy:]

Hi, all and congratulations from me on the NDA filing. So you have a pretty large database that you can draw from between SONICS and LOGICS. And obviously, you've included all this in the NDA filing. I think you still have the restoration phase going on. And as well as the objects, I guess, first from the restoration phase, are we going to see any specific endpoints reporting out at any point? I guess it's not going to be at ENDO, but are we going to be seeing those at some point this year? Do you need to submit any of that to the FDA to finalize the review? And I guess the same goes for OPTICS, what specific endpoints should we be looking for or can we be looking for and will they want to see that as well? So that's the first question. Then, as far as the, I guess, the QR benefits of RECORLEV, I know you've spoken about the androgenic effects in your discussions with physicians post data, and I know that you haven't presented it yet, but you've been searching for payload , so is there anything else from the QR effects or any other effects that resonate with physicians as points of differentiation that we can look for as far as efficacy is concerned? And yes, no, I'll just follow up after that.

[John Johnson:]

Great, thanks, Annabel. I Appreciate you joining us and for the question. So Fred, why don't you take the first half of that question? And then, we'll dive into some of the things we heard from one of our recent Ad boards.

[Fredric Cohen:]

Right, so first was in terms of details of what we have and have not submitted, I'm not going to get into that level of detail, but what I will say is that the OPTICS study, obviously it's an ongoing study. We don't have any plans for interim analyses. That being said, we have access to the safety from the study on an ongoing basis. And certainly, the FDA is interested in knowing about the safety of the drug and so that is going to be a part of our submission from OPTICS. So hopefully that addresses that part. In terms of the restoration phase, we're still analyzing the results from the restoration phase. I do anticipate that this year you will see some or all of those results presented in a public uniform and scientific form, and or publication of some sort. So I don't have an exact timing on that yet. It really depends on when we get those data fully analyzed and reported out. And I think that addresses both of your questions, but if not, please follow up.

[Annabel Samimy:]

Sorry, go ahead.

[John Johnson:]

No, go ahead Annabel.

[Annabel Samimy:]

No, just on that point, on the restoration phase, are there specific endpoints that you're looking for or is it just a continuation of what we've seen from the LOGICS primary?

[Fredric Cohen:]

Right, it's basically the same endpoints just with restoration of active therapy. This is the rescue therapy that we mentioned, we use when patients lost control or through use of active therapy otherwise, and it's the same kinds of endpoints here in our free quarters are being the main one. The restoration phase in itself is considered an exploratory phase of the study. Nevertheless, it's of interest and I do look forward to sharing those results with you as soon as we can.

[Annabel Samimy:]

Okay, sorry, I interrupted before, but just wanted to clarify.

[John Johnson:]

Yes, no worry Annabel. It's John. So, you asked the question about, how does that play with KOLs and we continue to speak with them, as well as community endocrinologists and clearly, what they've told us is that RECORLEV is going to take an important place in their armamentarium. The side effect profile that Scott talked about in women earlier, clearly resonates with them, and clearly is an issue and an unmet need that's out in the marketplace. And as he said, about 75% of the market is female, and so is, as we look at it, for us that's an important piece. The fact that 40% of the patients roughly are not well controlled, as determined by their physician, leads us to believe that there's real market opportunity and is recent launch, frankly as confirmed that hypothesis. I think beyond that, what the physicians have told us thus far is that having a product like RECORLEV, which has ketoconazole as a piece of the product is important. And the fact that it's been studied, that there's substantial evidence, and that they'll be clear instructions for physicians on how to use it, and assuming it's approved, it will be an on label use, is something that's very comforting and something that they point to that would likely lead to the kind of uptake that we've projected forward to you. So, we're continuing to research that. Scott's team is doing a tremendous amount of work. As I said in my opening remarks, we will certainly provide more insight into that as we go through the course of the year, but we're very encouraged by what we've heard from our own market research and advisory work and we're also encouraged to see the progress that this research has made.

[Annabel Samimy:]

Okay and one last question if I may. I know you're not providing OpEx guidance, but just to provide a little color around it, is the decline in R&D going to be sufficient to offset the increases in SG&A or should we assume overall larger OpEx this year by a decent magnitude? Thanks.

[Richard Kollender:]

Yes, the OpEx will decline pretty substantially in R&D as you just mentioned, due to the timing of the -- completion of the LOGICS study, and it will more than offset some of the increases that we're going to see in SG&A relative to the investment behind RECORLEV pre launch.

[Annabel Samimy:]

Great, thank you.

[Operator:]

Thank you. Our next question comes from the line of Jonathan Wolleben with JMP Securities. Your line is now open.

[Jonathan Wolleben:]

Hi, good morning, and congrats on the progress and thanks for taking the questions. First from me is on KEVEYIS, obviously a great year in 2020 and I appreciate you providing guidance in 2021. I was hoping you could provide some of the underlying dynamics that are driving that guidance? And if you've seen anything as of late as far as either persistence or new patient ads, as we're seeing COVID cases drop that might benefit you throughout 2021?

[John Johnson:]

Hey thanks, Jonathan. I'll have Scott address that and then I'll come in at the end. Scott?

[Scott Wilhoit:]

Yes, John, good question. And, the guidance we've provided against the long and short of it is kind of based on the current environment, which of course includes this kind of COVID environment that we're still in and there are still many unknowns, while it appears that it's going in the right direction right, there's new strains and variants and so forth. So still in our mind a number of unknowns. I think earlier, we mentioned too, we're hopeful that as the pandemic continues, and vaccines are increasingly available, that we're hopeful that the population including the PPP patients, patient population will have more access to their physicians, and that may lead to more diagnosis and certain options for -- certainly options for treatment. That said, I think our guidance reflects many of the unknowns that I just mentioned. But we're hopeful that as I said that, as the pandemic eases, that access will improve and then we'll see what impact that has. I think we've had a number of learnings from this environment and that is our ways of interacting with physicians and patients. We've been, more innovative in terms of the programmatic things we've developed to engage them. And certainly, once they're on therapy as we mentioned, our conversion and our retention rates have been really positive, we would hope that that would continue. But our guidance really reflects the current environment that we're in and really still a number of unknowns.

[John Johnson:]

Yes, and I would just add on to that Jonathan and say, the access for patients to physicians, because the diagnosis isn't straightforward. It doesn't happen on one visit. Many patients struggle within the healthcare system for a number of years to get the proper diagnosis and oftentimes say, present to the ER. And so, their ability to get diagnosed and to have access and to frankly, feel comfortable going into a physician's offices is something that we're going to keep a close eye on. There's a lot happening as you well know and better than I on the vaccine front. We also see these new variants that Scott has talked about. So we have the guidance in place. We feel very good about it. For us to see the business grow even faster we would want to see access for both patients as well as our teams to be able to go in and help these patients. And it's really unclear as to what that will be, but we feel comfortable with our guidance and that's why we reaffirmed it.

[Jonathan Wolleben:]

Thanks for the color. Moving to RECORLEV, there's been some questions on OpEx and SG&A. Could you remind us of the synergies between what you have with KEVEYIS as far as personnel and commercial infrastructure, and what you're looking down the line for with RECORLEV?

[John Johnson:]

Sure, I'll start and Scott feel free to jump in. All the core functions, marketing, marketing services, data analytics, advocacy, patient services, reimbursement, Specialty Pharmacy, distribution, all of that will be 100% leverage. And that was one of the big pieces certainly for us as we look to bring KEVEYIS into the company. And so there is a lot, and I would say that as I look back at the last several years we've had a lot of learnings. We've gotten much, much better at what we do and I'm really proud of the team's performance last year, especially when you consider the pandemic. And so, I know they're all excited to bring that same kind of service to patients and physicians inside of Cushing's. And we will leverage that. As it relates to the sales force, we're definitely going to leverage. I think it's exactly what the ad is going to look like and how many more we might need or how we might structure that, we continue to examine that. Scott will provide more updates as we go through the year. But the short story is, KEVEYIS has allowed us to build a profitable, because it is contribution margin positive, commercial organization that we will leverage. We will make some ads. We will add a head here or there and marketing head here or there and reimbursement, and then on the sales force, we're still looking at what exactly that would be. But we're really proud of what the group has done and the quality of people that Scott has brought in. I don't know Scott, is there anything that I missed on that question you'd like to add?

[Scott Wilhoit:]

No, I think you covered it, John?

[John Johnson:]

Thanks.

[Jonathan Wolleben:]

Thanks, John. Last one from me actually. Previously, you mentioned that you're not expecting an Advisory Committee meeting for RECORLEV. I was wondering if that's still the expectation. Thanks, again for taking the questions.

[John Johnson:]

Well, thank you, Jonathan. Fred?

[Fredric Cohen:]

Jonathan, that is our expectation and it hasn't changed.

[Operator:]

Thank you. Our last question comes from the line of Robin Garner with Craig-Hallum. Your line is now open.

[Robin Garner:]

Congratulations everyone on the quarter and thank you for taking my questions, just two quick questions amongst a number of really great ones. First, can you share how many patients you're currently treating on KEVEYIS and how many patients would represent a peak market or a saturation point, given that you've had such a strong quarter?

[John Johnson:]

Scott, do you want to take that?

[Scott Wilhoit:]

Yes. To date, we haven't disclosed the number of patients that we have on therapy and we haven't disclosed that at peak. I think, just from a penetration perspective, when I back up and think about it from a diagnosed prevalence perspective, there's -- we believe based on the work we've done there's 4000 to 5000 diagnosed PPP patients in the market. And so there's -- while we have done a good job at finding physicians who may have patients and getting them on therapy and increasingly do a better job at keeping them on therapy, there's still a lot of opportunity ahead to serve this patient population.

[Robin Garner:]

Okay, great. Thank you. This might be another question for you, Scott. What additional launch preparedness activities are needed this year to ensure a successful launch?

[Scott Wilhoit:]

Yes, good question. Well, as John mentioned, we've -- and as I mentioned in my remarks, we've got a number of key wins that we've kicked off and we're gaining some insights, and we mentioned those earlier. So I think all of those are important in terms of our marketing, how we're going to position the product, some additional work will be clear messaging and segmentation within the marketplace. We're doing some great work in our Medical Affairs Group and Fred can comment on this as well. But burden of illness work, which will help, not only inform the broader audience around the burden of this illness from a clinical perspective, but also be important for payers. We're doing a lot of things in the sales force structure and sizing and optimization, as John mentioned, more work to be done there. From a market access and distribution perspective, as John mentioned, as well, we're fully leveraging the work that we've done with KEVEYIS whether it's with our potential partners, or thinking about it from a payer perspective. So there's opportunity for us to, prepare the market, if you will, in the pre launch phase from a payer perspective, and then certainly accelerate that when we potentially get approval. I think those are really many of the key areas. There are other areas, but I think those are the key areas. So I guess the last one I've not mentioned is the advocacy, making sure that we're working with them, to make sure we fully understand the unmet needs of the community or working with them to increase awareness and education about the disease and certainly the potential of new treatment options when that's appropriate. That's really important. And I mentioned earlier, that Fred's team and the MSL Group, continuing to work with key opinion leaders as our pretty comprehensive data set moves through the NDA approval process. So those are a number of things that we're doing here at the market for launch.

[Robin Garner:]

Okay, great. Thank you. Congratulations again to everyone on a really strong quarter. I'm looking forward to more updates this year.

[John Johnson:]

Thank you, Robin.

[Scott Wilhoit:]

Thanks, Robin.

[Operator:]

Thank you. There are no further questions. I will now turn the call back to Mr. John Johnson for closing remarks.

[John Johnson:]

Thank you. In closing, Strongbridge made significant progress in 2020. Thanks to our dedicated employees who continued to drive forward many critical efforts, despite the myriad of challenges that COVID-19 presented us. 2020 was anything, but business as usual. And I'm very grateful to our employees and their continued ability to be flexible, fluid, and focused on serving the unmet needs of our rare disease patient populations. It was indeed for us a year of exceptional execution. We look forward to another great year of accomplishments, including further revenue growth for KEVEYIS, potential FDA approval of RECORLEV for patients with the largest Cushing's syndrome and active commercial launch preparation. Thank you for joining today's call and for your continued support. Have a great day.

[Operator:]

Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.