Q4 2020 Strongbridge Biopharma plc Earnings Call
Ladies and gentlemen, thank you for standing by and welcome to the strong bridge Biopharma plc, corporate update and fourth quarter 'twenty 'twenty earnings Conference call.
At this time all participant lines are in a listen only mode.
After the Speakers' presentation, there'll be a question and answer session.
To ask the question go under the session you would need the press Star then one of your telephone. Please be advised the today's conference is being recorded if you acquire any further assistance. Please press Star then zero I would now like the hand of the conference over to your House Lindsay Rocco Elixir Health Public relations. Please go ahead.
Thank you and good morning, everyone. We are pleased that you could join US today for strong bridge Biopharma fourth quarter and full year 2020 results and corporate update conference call joining.
Joining me from strong bridge. This morning are John Johnson, Chief Executive Officer, Scott Wilhoit, Chief Commercial Officer, Rich Colander, 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.
The friends 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.
Thanks, Lindsay and thank you for joining us this morning.
Before we begin I'd like to take a moment to welcome rich column there 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 strong for instance September of 2019 and.
And previously served on strong bridges board of directors and the chairman of our audit Committee.
Richardson of 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 the successful rare disease organization.
We would also like to thank Rob lots for his contributions to the strong bridge and we wish him well for this new opportunity outside of the company.
2020 was a year of exceptional execution for strong bridge.
I want to express how proud I am of the many significant accomplishments that the strong bridge team achieved throughout the year.
Despite the extraordinary circumstances brought on by the global COVID-19 pandemic strong for to achieve strong revenue growth for cause this while also making significant progress in our clinical development program for record of.
The endogenous Cushings syndrome.
I'm extremely pleased to report the yesterday, we announced the submission of.
Of the recall of new drug application to the U S food and drug administration, which is based upon the previously reported positive non statistically significant results of the phase III Sonics and logics trials.
The submission of the NDA represents not only of significant milestone for strong bridge, but for the Cushings syndrome community as the whole.
As an organization focused on developing treatments for underserved rare disease patient populations. We are encouraged to be one step closer the helping address the needs of the estimated eight thousands of Cushing syndrome patients in the U S who are treated with prescription therapy, many of whom are not well controlled.
We continue to thank the many patients their families investigators collaborators and our employees, especially Dr. Fred Cohen, our Chief Medical Officer, who have greatly contributed to the record of clinical program, leading to this important regulatory milestone.
Fred and his team have worked tirelessly on the submission since we announced the positive topline results from the phase III loss of study back in September of 2020.
Not only have they completed a compelling and comprehensive the NDA submission package with substantial evidence of efficacy and safety, but they are also ensuring the continued scientific exchange of data stemming from our phase III studies of both Congresses, and then publication for them.
Fred will be joining us for the Q&A portion of the call.
Recently, we confirmed that the interim safety and efficacy results from the phase III logics study have been accepted for poster presentation at the endocrine societies Endo 2021, the annual meeting taking place virtually later this month for March 'twenty to 'twenty three.
And we look forward to discussing these with the medical community.
If our NDA was accepted in the unapproved following a projected 10 months of the due for review cycle. The launch of recall of as anticipated in the first quarter of 2022, we look forward to working with the FDA through their review of our application.
We will be leveraging our rare disease commercialization expertise and infrastructure to bring recall of the others.
Christians community and we are actively working on our go to market strategy, which we will address in more detail on future calls.
Yeah.
Turning to the Vegas.
We achieved the various revenues of $8 2 million for the fourth quarter and $37 million for the full year exceeding the company's projected 28 millions of $29 million guidance range and representing a 41, 5% increase.
Over 2019 revenue of $21 7 million.
I would like to recognize the <unk> team led by Scott Wilhoit, Chief Commercial officer, who will speak in a few moments for continuing to drive this impressive growth in for the team's unwavering commitment to continuing to meet the needs of the primary periodic paralysis community. Despite the ongoing and unique.
<unk> is posed by the global pandemic.
Importantly, the company continues to fully prosecute the conveyors intellectual property estate and utilize all means available up to and including the appeals process. We currently expect to provide a further update during the second half of this year.
With that I will turn the call over to Scott, who will provide some additional color on the quarter's accomplishments Scott.
Thank you John Good morning, everyone and thanks for joining us as John mentioned, we were very pleased with the basis of performance in the fourth quarter and overall in 2020 and are confident that we can continue to grow the brand in 2021 and beyond.
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 generating new referrals by creating new and innovative ways to interact with health care providers and patients. We believe that our rapid response of the pandemic.
And ongoing health care provider and patient execution contributed to the both the steady flow of referrals and new patient starts for the Vegas and improvement in conversion and retention rates.
We hope that increase vaccination rates and more normal access for patients for their primary care physicians rollout for patients suffering from this debilitating disease that would be more readily diagnosed and treated in the future.
Moving onto the core of as John mentioned, we are excited to have submitted our NDA to the FDA and given our enthusiasm for the Korlym. We've aggressively moved ahead with launch preparedness activities.
Some of these include activities.
Include ongoing cultivation of key opinion leader and patient advocacy relationships.
Development of the correlate brand positioning sales force sizing and optimization and market access access activities as well as ongoing health care provider 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 of launching both of ASML.
That's moving closer to the of a course of launch throughout the coming year.
We will plan to provide more in depth of updates on our progress and on the marketplace. We expect to be competing now with that I'll turn the call over to rich for a review of our financials before we open up the call for questions Rich.
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 read through all of those details my comments will focus on some key financial results and guidance 2020.
The very strong financial year for our company.
For the full year 2020, net revenues from sales of <unk> increased $9 million or 41, 5% from $21 7 million for the 12 months ended December 31, 2019, the $37 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.
Gross margins were 93% for 12 months ended December 31, 2020, compared to gross margins of 82% for the same period in 2019.
Selling general and administrative expenses were $40 9 million for the 12 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 head count reductions reduced.
We do spending due to COVID-19 travel restrictions and lower third party expenses.
Additionally, the prior period of $3 2 million in one time charges for severance expense.
Research and development expenses were $25 8 million for the 12 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 III clinical program for core lab.
Turning to 2021.
This morning, we also confirmed our full year 2021 revenue guidance for cash of $34 million to $36 million.
Regarding operating expenses, although we don't provide specific guidance, we expect net 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.
SG&A, we expect expenses will be modestly higher in 2021 versus 2020 as we invest in preparations for the launch of our core lab, while also maintaining our SG&A investment and growing Tobias.
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 for core lab FDA approval.
Based on our projected revenue and spending as well as the expectation we can borrow an additional $10 million from our debt facility. Upon recall of approval, we expect our cash will last into and potentially beyond the first quarter of 2023, we believe our current cash balance and operating plan.
It gives us flexibility on when and how to access additional capital.
And operator with that we're ready for questions.
Thank you.
I'll ask a question you will need the press Star then one of your telephone to withdraw your question. Please press the pound key.
Our first question comes from the line of Chris Howerton with Jefferies. Your line is now open.
Hey, good morning, and congrats.
Congratulations on getting the submission done that's obviously, a really big milestone.
Milestone for the company, so congratulations, especially to Fred and the team there.
Hey, Thanks, Chris I appreciate it.
Awesome Alright.
Alright, well, maybe just a couple of quick ones for me I think you know obviously very pleased to see.
The strong performance of convey is but.
If we were to think about.
What's going on in the Cushing syndrome landscape right now I would think that is Teresa is probably the most.
Comparable launch to what record of live 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.
Yes, Chris happy to take that Youre right I mean, its recent and relevant.
The first of all as we said on previous calls we're rooting for them because of the the unmet need in Cushing syndrome and the patients.
In the category are underserved so.
We think they are off to a pretty good start given the launch kind of.
In the middle of if you will of this pandemic last year in the May timeframe.
You probably saw the.
The disclosures and the recent the.
The recent announcements, we think theyre off two of which starts.
So we're rooting for them in terms of.
How we think about the market as you know.
It's pretty comprehensive market assessment included as Teresa.
<unk> of assessment and record of living its profile and the date of the French team has generated through our phase III programs.
It really the profile of those competitive across the category, including against the history. So we believe theres opportunity ends of the day in particular.
In a significant portion of the population that's women and as you know that 75% to 80% of the population. So some of the side effect profile associated with products on the market.
Including histories are potentially problematic there and we think that the profile for the quarter. It may be very attractive for for that segment, but as I said the.
The product recall of it.
It was very true.
Compelling in terms of its performance across the category not only distribution, but.
Against ketoconazole of as well so hopefully that provides for some color yeah no debt.
Very helpful.
Sorry go ahead, John sorry, yes.
No I was just going to add Chris that.
So really a solid launch given the pandemic and I think what we were encouraged by was you know what we've heard anecdotally from from payers in from the field.
And from physicians, frankly that they're getting reimbursed and that reimbursement is coming in many cases from generic product and I think it goes to just show that rare disease patients continue to get some degree of priority access when the when the physician intervenes and so.
We've been pleased with that.
And hats off hats off to them for having us.
A solid start in the middle of the pandemic and.
Just heading into the summer so, let's see what what happens as patients get more into the office and.
As the vaccine continues to rollout, but good start and certainly supports our hypothesis.
Yeah Okay.
Very good and Scott, maybe if I could maybe just make a.
A quick clarifying question in one of the things you said.
With respect to the side effect profile.
Particularly in women would you provide a little more color on the specifically what you mean, there and maybe like what what degree of problem that is.
Yes, having interest so our research really when we talk to physicians just to remind everyone.
Quantitative study with 153 endocrinologist and we had them look at the top attribution and one of those of us.
Several of the side effects that the.
You have to deal with with certain products and in particular, the androgenic effects of products and the impact on women.
The debt causes so the.
The excessive of hair growth for acne oily skin those types of things ranked fairly high in terms of the.
The unmet need debt position space when they are prescribing products and certainly our product tested very very well in that regard.
So we think that thats.
Significant opportunity based on our clinical profile and since that impacts women. That's the substantial portion of the market. So.
That's the bare it out in our research and we will continue to do some more research there, but we think thats a significant opportunity for our product and the and the date of the Fred's team has generated.
Got it okay. That's great. Thanks, Scott.
Alright, and then maybe just another a couple of quick ones I think probably related to some degree.
John you know like what any updates for the plans for the Delta.
Well, the Ria tide and.
Anything else, we should be thinking about with respect of future business development plans.
Well you know, we're not going to speak Chris to you know to the.
For the future BD at this point all I would say is that rich and his team are actively screening for <unk>.
Tenths of opportunities as it relates to the Oreo side Fred.
Fred maybe you want to give some commentary on that.
Yeah. So we have been actively studying the el Dorado size at.
At this point, we're still looking at our options, what we wanted to do with that.
And in the future I expect rich Raj will give you an update on that Chris sorry, sorry for no update today.
No no that's fine.
Al.
I think that's it for now and I appreciate you guys taking the questions.
Thanks, Chris Thanks, Chris.
Thank you. Our next question comes from the line of hardest thing with Oppenheimer <unk> Company. Your line is now open.
Great. Thank you for the questions and also of kudos on all of the good work.
The one just a couple of quick ones one is.
The poster presentation at Endo non to front run it.
But can you just give us an idea of what to look for one of the things to expect also how it relates relative to.
Of the various presentations you've done on Sonics.
The the preceding trial, that's number one and then number two.
Thanks for the updates on <unk>.
The answer is doing better.
I think the fact that you're able to increase sales.
The year on year during the pandemic was pretty impressive.
Is there something else just fundamentally happening in the market is there a structural shift to maybe more awareness.
Amongst physicians, so that more patients are potentially coming to be treated or being better screen et cetera. Thank you for the question.
Hey, Thanks arbitrage Fred why don't you start with the end of question of nimble, we'll go to Scott.
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.
Two of an investor audience. This is our first opportunity with the science of audience and basically its going to be largely what we've shared in terms of of the topline, but more just more detail around that.
More detail around the efficacy.
As well as detail around some of the kind of <unk>.
Safety analyses that we've done just basically fleshing out those data were not because it would be presenting.
A bunch of.
Sort of exploratory or secondary now so it's really focused on the main study results.
Great. Thanks, Brent.
And Scott.
Sure Yeah. Good question I think.
A couple of things one is that we're the only company out there thats actively promoting supporting the PPP community and have been now for several years. So I think.
That overtime definitely has some impact our relationship with advocacy has been a very positive relationship and as you know in rare disease advocacy 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 the other thing or just the fundamentals, whether it's debt within the pandemic or outside of it.
<unk> to identify physicians, who may have patients.
Fairly rapidly and quantify them, if you will to determine if the.
If this patient may be a candidate for <unk>.
The improved those.
That that area of our business, which enables us to get high quality referrals potentially a little more throughput and then we thought we consistently work on our patient service patient services team the <unk>.
Convert these patients to drug there for us.
<unk> writes a prescription as quickly as we can and work with the patient and the doctor to to maintain the monotherapy. So I think the model that we've developed which is the which as we've talked about is very levered to both for the quarter.
All of those things I think of helped us continue to grow the market.
So hopefully that provides you a little bit of insight.
Yeah, no that's very helpful.
One of the questions a follow up I know that can be.
Originally you got it from Taro.
I believe the generics company.
Working on the IP extension could you just maybe talk a little bit about the different scenarios.
Assuming you don't get IP, I mean with generic companies really wanted to enter again.
And for this market.
The sort of gave it the strong bridge earlier or if you did get IP, how would that potentially change anything kind of again. Thank you for the questions.
Thanks for implies no book integrate question and if you look at rare disease drugs I mean, the fact that they're given through specialty pharmacy.
And you.
You know, there's a lot of handholding that needs to take place for reimbursement.
To have a hub to properly serve those patients is an important factor.
You look at the market as a whole year of about 50% of the drugs that have had some type of generic entry with various levels of success.
We 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 is not a group of patients that go to the centers of excellence excellence that you can contract with 10 centers and and go ahead, and you know and pull of the business from there. This is really a business where the.
Diagnosis still remains challenging.
It's spread out throughout the community. So it's not an easily accessible pop.
Population to try to bring the 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 and of our IP and.
Certainly the the guidance we've been given from outside counsel about the.
Future IP all of that being said this is of patient population that we want to serve that isn't easy to serve and.
The 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 brought this disease you know more to light we have more work to do there.
And assuming that.
You know we have.
The extended the IP, we would invest more heavily in continuing to develop that market versus the uncertainty of of the generic but you know all of that being said, we're doing really good work every day with cap patients out of the hospital.
As they've told us during COVID-19.
And.
Especially out of the emergency rooms, as the feedback we've received and as such we're proud of what we've done and we're going to continue on our mission to serve those patients.
Great. Thank you John.
Thank you. Our next question comes from the line of Annabel Sammy with Stifel. Your line is now open.
Hi, Al and congratulations for me on the NDA filing.
So you have a pretty large database.
That you can draw from between Sonics and logics and obviously you can create all of us in the NDA filing.
You still have the restoration phase going on and as well as.
The optics I guess first.
From the restoration sales are we going to see any specific endpoints reporting out at any point of I guess, that's not going to be at endo, but.
Are we going to be saying, there's at some point. This year do you need any of that to the FDA.
The finalized the room for you and I guess the same goes for optics for specific endpoint should we be looking for can we be looking for and.
And will they want to see that as well. So that's the first question.
Then.
As far as the eye.
I guess, the key benefits of record of Liz.
I know you've spoken about the Andrew Seneca effects in your discussions with physicians post data and I know that you haven't presented it yet.
<unk> been searching for Kols. So is there anything else from the kols effects or any other effects of that.
That <unk>.
Resonate with physicians as points of differentiation.
The we can look for as far as the efficacy is concerned.
And yes, I'll just follow up after that.
Great. Thanks, Annabel appreciate you joining us and for the question so sort of 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.
Right so.
The first with in terms of.
Details of what we have and have not submitted I am not going to get into that level of detail of what I will say is that the optic study. Obviously, it's an ongoing study we don't have any planned formal interim analyses.
Being said, we have access to the safety from the study on an ongoing basis and certainly.
Of the FTA is interested in knowing about the safety of the drug and so that is going to be of part of our submission for.
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 the this year you will see some or all of those results presented.
In the public form of scientific Forum.
Andrew our publication of some sort of.
So I don't have an exact timing on that yet it really depends on when we get those data.
Fully annualized in reported out.
And I think that addresses both of your questions, but if not please follow up.
Yeah.
I'm sorry.
Sorry go ahead.
No go ahead of them, though.
Just on that point on the restoration phase are there specific endpoints debt that youre looking for or is it just a continuation of what we've seen from <unk>.
From the from the logic of the primary.
Right, it's basically the same endpoints.
Just with.
Restoration of active therapy.
For the rescue therapy that we mentioned, we use when patients loss control or.
Through use of active therapy.
Otherwise.
Yes.
It's the same kinds of endpoints urinary free cortisol being the main one of the restoration phase in of 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 soon.
Free cash.
Okay, sorry, I interrupted.
I just wanted to clarify.
No worry annabel.
It's John So you know.
You you asked the question about you know how does how does that play with with Kols and.
We continue to just speak with them as well as community endocrinologists.
And clearly what they've told US is that <unk> was going to take an important place in the armamentarium.
The side effect profile of that.
<unk> talked about in women earlier.
Clearly resonates with them and clearly is an issue in an unmet need that's out in the marketplace and that's you said about 75% of.
Of the market is.
The female and so as we look at it.
You know for US that's an important piece the fact that 40% of the patients roughly are not well controlled as determined by their physician.
The leads us to.
I believe that there's a real market opportunity and the history for launch frankly as you know.
Confirm that hypothesis I think beyond that.
What the physicians have told us thus far is that having a product like a recall of which you know.
Has ketoconazole is as a piece of.
Of the product is important and the fact that it's been studied that there is substantial evidence and that there'll be clear instructions for physicians on how to use it and assuming it's approved it will be.
On label use is something that is very comforting and something that they point to that would likely lead to.
The kind of uptake that we projected forward to use so we're continuing to research and Scotts 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.
The market research and advisory work and we're also encouraged to see.
The progress of this Teresa has made.
Okay and one last question, if I may be I know youre, not providing opex guidance.
Is that just to provide a little color around it is the decline in R&D.
You're going to be.
Sufficient to offset the increases in SG&A or should we assume overall larger opex this year.
Bye.
Magnitude.
Yes.
The Opex will decline.
Pretty 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 an SG&A relative to the investment behind <unk> of prelaunch.
Great. Thank you.
Thank you. Our next question comes from the line of Jonathan <unk> of it with G. JMP Securities. Your line is now open.
Hey, good morning, and congrats on the progress of thanks for taking the questions.
The.
First for me is on the various obviously a great year in 2020 and I appreciate you providing guidance on 2021.
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 of new patient adds as we're seeing COVID-19 cases drop that might be the benefits you throughout 2021.
Hey, Thanks, Jonathan I'll have.
Scott address that and then I'll come in at the end of Scott.
Yes, John Good question.
The guidance, we provided I guess, the long and short of it is the is kind of based on the current environment, which of course includes as kind of COVID-19 environment debt.
We're still in it and there are still many unknowns.
Here's the dates.
Going in the right direction, right, Theres, new strains and variance and so forth. So.
Still in our mind, a number of unknowns I think earlier you mentioned two we're hopeful that.
As the as the pandemic continues and vaccines are.
Increasingly available that we're hopeful that the population, including the PPP patients patient population.
We will have more access to their physicians and that may lead to.
The more diagnosis and certain other options for certainly options for treatment.
I think our guidance reflects many of many of the unknowns that I just mentioned.
But we're hopeful that debt as I said that is the <unk>.
Pandemic eases.
Net debt at that access will improve and we will 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 are on therapy as we mentioned our conversion.
Our retention rates have been really positive we would hope that that would continue.
But our guidance really reflects the current.
The environment that we're in and really still a number of unknowns.
Yes, I would just add ons, yeah, I would just add on to that Jonathan and say you know the access for patients.
Two positions because of the diagnosis isn't straightforward it doesn't happen on one visit many patients struggle within the health care system.
For a number of the years to get the proper diagnosis and oftentimes they.
Present to the E R M.
And so their ability to get diagnosed and to have access into frankly feel comfortable.
Going into of physicians 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 the eye on the vaccine front. We also see these these new variants.
The Scott has talked about.
We have the guidance in place we feel very good about it.
You know for us to see the business grow even faster we would want to see access for 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.
Thanks for the color.
Moving to a record of loads.
Some questions on Opex and SG&A.
Can you remind us of the synergies between what your what you have with the vendors as far as personnel and commercial infrastructure and whats Youre looking down the line for Korlym.
Sure I'll start and Scott feel free to.
The jump in.
All of the core functions marketing marketing services data analytics and advocacy.
The patient services reimbursement of specialty pharmacy distribution all of that will be of 100% leverage.
And.
That was one of the big pieces certainly for us as we look to bring convey a sense of the company.
And so there is a lot and I would say that.
As I look back at the last several years, we had a lot of learnings we've gotten.
Much much better at what we do and.
I'm really proud of the of the team's performance last year, especially when you consider the pandemic.
So I know, they're all excited to bring that same kind of of service to patients and physicians inside of the <unk>.
Cushings.
And we will leverage that as it relates to the Salesforce, we're definitely going to leverage that exactly what that's going to look like and how many more we might need or how we might structure that we.
We continue to examine that Scott will provide more updates as we go through the year, but the short story is.
<unk> has allowed us to build a profitable.
Because of this contribution margin positive.
Commercial organization that we will leverage.
We will make some ads.
Head here or there in marketing ahead 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 them in I don't know Scott is there anything that I missed on that question like that.
I think you've covered it John.
Thanks.
Jonathan.
Last one for me actually.
You mentioned that you are not expecting an advisory committee meeting for call of <unk>.
Wondering if that's still the expectation. Thanks, thanks for again for taking the questions.
Thank you Jonathan on for Ed.
Jonathan that is our expectation hasnt changed.
Sure.
Thank you.
Our last question comes from the line of Robin Garner with Craig Hallum.
Your line is now open.
Congratulations everyone on the quarter and thank you for taking my questions. Just two quick questions amongst the number of really great ones.
First can you share how many patients who are currently treating of COVID-19 and how many patients would represent a peak market, whereas saturation point given that you've had such a strong quarter.
Scott you want to take that.
Yes, we haven't disclosed the number of patients that we have on therapy, and we haven't disclosed that at peak I think.
Just sort of penetration perspective, our total.
Backup and think about it from the diagnosed prevalence perspective. There is we believe based on the work. We've done this for the 5000 diagnosed PPP patients in the market and so there is while we have done a good job.
The physicians, who may have patients and getting them on therapy and increasingly doing a better job of keeping the monotherapy theres still a lot of opportunity ahead to serve this patient population.
Okay, great. Thank you this might be another question for you Scott.
The additional launch preparedness activities are needed this year to ensure a successful launch.
Yes. Good question will as John mentioned 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.
I think.
All of those are important in terms of our marketing and how we're going to position the product. Some additional work for me.
Clear messaging of segmentation within the marketplace. We're doing some great work at our medical Affairs group and trade can comment on this as well, but burden of illness work, which will help.
Not only in the form the broader audience around the burden of this illness from the clinical perspective, but also of the important for payers.
We're doing a lot of things.
In the sales force.
The 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 <unk>, whether it's with our potential partners or thinking about it from a payer perspective.
So there is opportunity for us too.
Prepare the market if you will in the prelaunch phase from a payer perspective, and then certainly accelerates that and when the 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 both of those are the key areas I guess the last one of that he mentioned is the advocacy making sure that we are.
Working with them to make sure we fully understand the unmet needs of the community.
We're working with them to increase awareness and education about the disease and certainly in the potential of the new treatment options. When that's appropriate that's very important and I.
I mentioned earlier the <unk>.
Fred steam in the MSL group continuing to work with key opinion leaders as the.
Pretty comprehensive dataset.
Through.
The Anda approval process those are a number of things that we're doing preparing the market for launch.
Okay, great. Thank you congratulations again to everyone on a really strong quarter and looking forward to more updates this year.
Thank you Robyn Thanks Robyn.
Thank you there are no further questions I will now turn the call back to Mr. John Johnson for closing remarks.
Thank you in closing strong growth made significant progress in 2020.
Thanks to our dedicated employees, who continue to drive forward many critical efforts.
Despite the myriad of challenges the 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 the various potential FDA approval of our korlym for patients with the endogenous Cushings syndrome.
And active commercial launch preparation.
Thank you for joining today's call and for <unk>.
And your support have a great day.
Ladies and gentlemen, this concludes today's conference call. Thank you for your participation you may now disconnect.
For me.
Okay.
Yes.
Sure.
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