Q1 2021 Strongbridge Biopharma plc Earnings Call
Excuse me. This is the operator todays conference is scheduled to begin momentarily until that time your lines will again be placed on music hold thank you for your patience.
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Good morning, ladies and gentlemen, and welcome to the strong bridge Biopharma plc, corporate update and Q1 2021 earnings conference call. At this time all participants are in a listen only mode. Later, we will conduct a question and answer session and instructions.
Will follow at that time.
Anyone should require assistance during the conference. Please press Star then zero on your Touchtone telephone as debt.
From minor at this conference call is being recorded I would now like to turn the conference over to your host Lindsay Rocco of Elixir Health public relations.
Thank you and good morning, everyone. We are pleased that you could join US today for strong bridge Biopharma as first quarter 2021 earnings and corporate update conference call.
Joining me from strong bridge. This morning are John Johnson, Chief Executive Officer, Dr. Fred Cohen, Chief Medical Officer, Scott Wilhoit, Chief Commercial officer, and Rich Colander, President and Chief Financial 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.
Thanks, Lindsay and good morning, everyone and thank you for joining us today.
Since our last investor call and despite the ongoing COVID-19 pandemic. We are pleased to report we have made significant strides in advancing our portfolio of treatments for rare endocrine and rare neuromuscular conditions.
I'd like to begin by saying that the company is eagerly awaiting the day 74 letter notification from the U S food and drug administration psoriasis surrounding the filing status of our new drug application for <unk> for the treatment of endogenous Cushings syndrome.
Fred will go into more detail. Shortly however, I would like to take a moment to thank the strong bridge team for their continued hard work and dedication as we await the notification from the FDA.
Our market research continues to show that there is significant unmet need in the treatment of endogenous Cushings syndrome, especially with women who are affected two times more often than men.
We look forward to working with the FDA to bring this important product to market.
I would also like to provide an update on the progress that we've made with regard to the intellectual property for record months.
As announced in today's press release, we are pleased to share that strong bridge recently received notification from the United States patent and trademark office that had that it has entered a notice of allowance for a U S patent application ending in 387.
During a method of treating Cushing syndrome patients with record low lever ketoconazole, who also take metformin for type two diabetes.
This notice of allowance includes the substantial examination of the patent application and is expected to result in the issuance of a U S patent after the administrative processes are completed.
The term of the U S patents is scheduled to issue from this application will expire in September 2040.
I would like to recognize Dr. Fred Cohen for his research that served as the basis for this allowance.
We are pleased with this progress, which marks an important step in our ongoing efforts to optimize the value of recalls and further strength and strong bridge leadership position in rare endocrine disease.
We will provide an update once a patent issuance is completed.
I will now comment briefly on to Vegas, and Scott will go into further detail about our quarterly revenue performance later on in the call.
The team delivered strong sales results from the first quarter with 25% quarter over quarter revenue growth versus the first quarter last year.
Providing a solid foundation as we enter the second quarter.
In fact I'm pleased to report the impressive Japan's performance continued for April during which we achieved the highest month of revenue ever for converse since we relaunched the drug in 2017.
The company remains on track to achieve our full year revenue guidance of $34 million to $36 million.
We believe that's a robust COVID-19 sales performance that we are seeing underscores the importance of this therapy and the unmet market needs. We continue to address for the primary periodic paralysis community.
As discussed on previous calls we continue vigorous prosecution of our intellectual property that we have developed for this and we will provide updates on key developments regarding these and other related activities as decisions are rendered we currently expect to be in a position to provide a further update on this topic during the second half.
Of this year.
Looking ahead, we remain focused on driving continued revenue growth from Tobias and leveraging our operational and commercial expertise as we prepare to launch <unk> upon FDA approval.
Finally, before I turn the call over to Fred I'm proud to announce a strong bridge has recently been recognized as a 2021, great place to work certified company.
Great place to work as a global authority on workplace culture employee experience and our leadership behaviors proven to deliver market, leading revenue and increased innovation.
The recognition spotlights, the passionate culture and the positive employee experience, we have created and nurtured over the years I want to acknowledge that this recognition would not be possible without this team's unwavering commitment to one another and to continuing to meet the needs of other rare disease communities that we serve.
With that I will now turn the call over to Fred who will provide additional details surrounding the status of the NDA filing for <unk> and our clinical development programs.
Thank you John.
As John mentioned the company is awaiting notification from the FDA regarding our NDA submission for record left for treatment of endogenous Cushings syndrome.
As background on the regulatory process day 74 letters from the FDA typically confirm finally get acceptance of an NDA submission and include other pertinent information such as the target to do faction date and the planned date for the internal mid cycle review meeting as examples.
Strong bridge anticipates, receiving the official day 74 letter for the record the NDA submission shortly and we look forward to providing an update thereafter.
With regards to recent scientific exchange of data from our clinical development program for core lab in April a diabetes subgroup analysis from the Phase III Sonics study for core lab was published in the peer reviewed journal frontiers in endocrinology.
In March interim safety and efficacy results, including new data analysis from the Phase III Logics study were also presented a poster at the endocrine Society Twenty-twenty long virtual annual meeting.
We are continuing to pursue additional manuscripts and presentation surrounding our logic study and look forward to share in key data with the medical community later this year.
As to scientific exchange concerning to Vegas and April a case report concerning a patient with Anderson Wilson drum switching from our centers all of my true today as was presented at the American Academy of Neurology virtual Nina.
This case report was also recently published in the peer reviewed journal neuromuscular disorders.
With that I will turn the call over to Scott, who will review key cube as highlights from the first quarter, along with ongoing core left launch preparation activities Scott.
Thanks, Brent and good morning, everyone as John mentioned cause I guess, our first commercial stage rare neuromuscular product performed very well in the first quarter. Thanks to our team's dedication to serving the many unmet needs of the periodic paralysis community and.
In the first quarter of 2021, <unk> achieved net revenue of $8 4 million, which represents a 25 per cent quarter over quarter increase from the $6 7 million in net revenue for the first quarter of 2020.
We attribute the first quarter performance to the growth in total patients on drug resulting from new patient starts combined with improved discontinuation rates for existing patients on therapy.
Additionally, as part of our comprehensive and ongoing mitigation plans surrounding the COVID-19 pandemic.
We remain focused on efficient virtual sales execution by improving the use of our physician targeting data, creating access and confirming potential TTP patients.
These efforts have provided a steady flow of new referrals with high levels of physician and patient engagement.
We also continue to utilize new digital marketing tactics with consistent and relevant content.
Which have led to an increased number of new patient leads.
Well at least from a patient services standpoint, there were also improvements in first pass prior authorization approvals and new patient onboarding, resulting in improved conversion rates and lower discontinue rates discontinuation rates during the quarter.
These debates results and our continued solid execution across key commercial functions provide a strong footing as we entered the second quarter.
Turning to record lows, we are continuing to aggressively move ahead with launch preparedness activities, including on going cultivation of key opinion leader and patient advocacy relationships.
Development of recording the brand position sales force sizing and optimization and market access activities as well as ongoing physician and patient market research as we move closer to the point of launch we plan to provide a more in depth update on our progress and on the marketplace. We expect to be competing with that I will turn the call over to rich.
Who will review our financial highlights from the first quarter before we open the call up to questions rich.
Thank you Scott the press release that we issued this morning contains details of our financial results for the first quarter of 2021, rather than read through all of those details my comments today will focus on some key financial results net revenue from sales of <unk> increased $1 $7 million or 25% to $8 4 million.
Compared to $6 7 million for the same period in 2020.
The company recorded cost of sales of <unk> 4 million compared to cost of sales of $1 million from the same period in 2020.
Cost of sales decreased due to changes in the assumptions underlying the allocation between the purchase price of our inventory and our supply agreement. Our first quarter gross margins were <unk> 95 per cent compared to gross margins of 85% for the same period in 2020.
Turning to our operating expenses for the first quarter of 2021, SG&A expenses were $10 9 million compared to $10 4 million for the same period in 2020.
The increase for the first quarter of 2021 was primarily due to an increase in our noncash stock compensation expense.
R&D expenses were $5 8 million compared to $7 6 million for the same period in 2020. The decrease was primarily due to decreases in costs associated with our logics and optics trials offset by increases in regulatory costs associated with our NDA submission.
Basic net loss attributable to ordinary shareholders on a GAAP basis was $11 8 million or <unk> 18 per share compared to a basic net loss attributable to ordinary shareholders of $12 7 million or <unk> 23 per share for the same period in 2020.
Net loss for the first quarter was lower than the same period in 2020 due to the increase in <unk> revenue of $1 7 million the improvement in our gross margin and the reduction in R&D expenses. Those decreases were offset by <unk> 8 million of interest expense recorded in the quarter and $1 $4 million change in.
The reevaluation of the fair value of our liability classified warrants due to the increase in the Companys stock price in 2021 as compared to 2020.
Non-GAAP basic net loss attributable to ordinary shareholders was $7 2 million or <unk> 11 per share compared to a non-GAAP basic net loss attributable to ordinary shareholders of $10 3 million or <unk> 19 per share from the same period in 2020.
The decrease in non-GAAP net loss was primarily due to an increase in <unk> revenue of $1 7 million and an improvement in our gross margin and.
In addition, R&D expenses decreased from the first quarter of 2021 compared to the same period in 2020 offset by cash interest expense in the first quarter of this year.
We ended the quarter with approximately $73 9 million in cash.
Based on our projected revenue and spending as well as the expectation we can borrow an additional $10 million from our debt facility. Upon we're looking for Korlym approval, we expect our cash runway will extend into and potentially beyond the first quarter of 2023.
We believe our cash balance and operating plan gives us flexibility on when and how to access additional capital.
And operator with that we're ready for questions.
Ladies and gentlemen, if you have a question at this time. Please press star and then the number one on your Touchtone telephone. If your question has been answered or you wish to remove yourself from the queue. Please press the pound key.
Your first question is from the line of Roger song with Jefferies.
Great. Good morning, guys. Thank you for taking my questions.
Just the first one is related to fewer players I think the sky.
Per the remark very interesting.
The sales improved.
Discontinuation rate for this population just curious what are the key drivers to.
Achieve that kind of a lower discontinuation rate here.
Yes. This is Scott I'm happy to take that one I think.
<unk>.
Looking at our operations and looking at how we can make improvements across.
How we are interacting with physicians and patients. So I think the first is really setting expectations around.
When a patient is going on therapy, both with the physician and if we have the opportunity with the consented patient with the patient. So I think that's first and foremost I think one other things that we did during the pandemic was too.
Focus our discussions with physicians and patients early in the treatment cycle and.
An example would be.
Reinforcing.
The dosing considerations.
In terms of how to titrate in the early phases of the treatment that's with the physician and certainly the expectations are that with the patient. That's just one example of the things that we do in terms of in terms of our communication.
Two important parties there I think the second thing is just the cadence of our calls and the focus of those calls in the early window.
If a patient going on treatment.
So we think that results and has resulted in improved engagement both on the provider and the patient side, which has especially been important during this pandemic phase and it's something that we will certainly leverage going forward.
That adds a little color to your your question.
No that's great.
Scott.
And the next question is related to core.
Core labs, so we incur from your competitor.
For the question from Joan space.
They are having some difficulty identifying new patients because the diagnostic in the titration kind of share.
Kind of burden from there just curious.
So assuming you worked at proved a couple months and book.
Dan.
When you start to launch the <unk> Cushing syndrome do you expect you will have some kind of Penn pop kind of or demand in the hall. If so how would you prepare to capture those kind of potentially delayed.
New patients Cushings syndrome.
Yes, Scott why don't I start and then you can you can finish what we know today is that there is significant unmet need we know debt up to 40% of the patients are described as not being well controlled.
Pfizer positions so to your point about pent up demand, we do believe that that's there you do see a lot of switching in this category.
And we certainly look at those patients that physicians believe arent optimally controlled or who may be having some side effects.
As the low hanging fruit when we when we first launch and that's a pretty significant part of the population Scott is there anything else you'd want to add to that.
No John I think I think that covers the waterfront from our perspective.
Okay. Great next question is from the line of hard Taj Singh with Oppenheimer.
Good morning. This is Jackie congrats on a great quarter and thanks for taking our questions I guess first.
First on a recorded so far and when we might see some data from the risk duration sales from logics.
Maybe it was just some preliminary data from the open label extension study Opex, just if you could frame kind of the data release publication and presentation strategies, there before before it first quarter.
True.
Hi, This is Brian.
I got it.
So for logic and the restoration phase.
As you pointed out so far we've disclosed results through the end of the randomized withdrawal phase, including the primary and key secondary endpoints of the study and safety to that time point, we do intend to disclose and report.
Scientific Forum.
The full logics study.
As we speak we're starting work on a manuscript and we intend to submit that just.
This calendar year I don't have an exact date for you at this point.
We may or may not present that at a scientific forum this calendar year it really depends on.
The opportunities available to us to do that and whether it's accepted but.
We decided to do that and.
Hi performed for that we'll announce that till later in the year, so that would probably be in the second half of the year.
In terms of the optic study, we don't have any plans to present the results any results from the optic study. This year that is a long term study that is expected to continue to have patients being observed both for efficacy and safety for it.
At least three years per patient.
And so we'll finish up until 2022 at the end of 2022, beginning of 2023, and we don't have an interim analysis for that currently.
Land, it's not to say that we couldn't do at interim analysis at some point.
If we so wish but at this point, we don't have any interim analysis plan and therefore, we don't have any immediate plans for an interim scientific presentation.
Again, though we are interested in sharing results of that study when you know as soon as we can and so at this point, we're thinking it won't be until the 2023 timeframe, but if we decide to do something before that time, perhaps in concert.
With launch activities will certainly.
Let you know about that.
Thanks, Brad and also from.
I think right now is about 70 to 71 days since you'll file the NDA.
Obviously, youre Cros that are important in 60 days.
Just wanted to make sure from your end.
You still expect.
There are 10 months review cycle adult AD com correct.
So right now, yes, I mean, your timing is correct.
Approximately so.
We do expect to have a day 74 letter shortly and we'll update the street when we.
Further information to report on the contents of that letter.
In terms of AD com.
No.
Do.
We anticipate debt with a day 74 letter that the FDA will inform us whether they believe that an advisory committee will be needed as part of the review of.
Part of the NDA I will point out that while we can't speculate on the potential actions of SBA at this point.
We do believe that the previously reported.
Positive results from logic, and Sonics provide substantial evidence that support the review and potential approval per quarter that's in.
N endogenous cushings syndrome.
And just remind you that an advisory committee.
It's not a mandatory step that the FDA would need to take with with our particular application.
Yes got it.
Got it and then last question, maybe for our gel or rich.
Assuming a quarter got a true I got from various shortly royalty.
Profitable I think IRA what right now is aware of the items tax.
But since you are Irish company, if you could just talk a bit more healthier Irish company could help you with that.
Strategy versus your peers here in the U S.
Yes, sure I mean, do you want to take that I'm happy to yes, I mean youre absolutely.
Totally right.
And so we do have a potential advantage ultimately when we are a profitable company.
From a tax perspective, given the expected.
Increase in corporate tax rates here in the United States with the biding proposal as compared to what we would anticipate our effective tax rate would be in the future.
For us as a profitable company. So there is a potential advantage there.
To see how that obviously plays out it's premature to comment further.
Got it great. Thanks from all other questions I guess.
Jump back into queue. Thanks.
The next question is from the line of Annabel <unk> with Stifel.
Hi, Thanks for taking my questions.
So.
<unk> had a chance to per cent or acquire live data now in a couple of Forman farms.
The Endo meeting we had him in journals can you talk about.
The feedback that youre getting from from this additional data.
I'm also curious about.
Their views relative to I guess, the competitive landscape history says also kind of out there trying to position for frontline. So just wanted to think of yeah.
Obviously your carloads also potential has potential for frontline. So maybe you can talk about it.
The feedback in terms of the competitive landscape.
Thanks.
Thanks, Annabel Fred why don't you talk a little bit about the reaction of the feedback you've got from physicians and then Scott you can take over positioning.
Sure.
So we have talked to a lot of.
So called key opinion leaders and of course investigators in the studies at this point I think the general reaction.
Particularly from folks who have used the drug is that it feels familiar to them in terms of the titration scheme in terms of the monitoring in terms of.
The efficacy that they saw the efficacy I think they believe.
It's highly competitive with what we've seen from other drugs.
Albeit with lesser potency compared to perhaps the newest drug as Teresa, which is very potent and as you know.
Has led to some alterations in the titration scheme, and so on and it tends to mitigate some of the.
Potency.
Issues in terms of people getting fees.
Feelings of.
It may be a drain on sufficiency.
And so that was brought out as a as a.
Differentiation. The other thing that was brought out as potential differentiation compared to some other newer drugs had to do with use of men versus women.
It was mentioned.
I would say nearly uniformly that the drugs act differently as Teresa versus leaving ketoconazole in terms of how they inhibit cortisol production and how they affect androgen production for example.
With androgens decreasing fair.
Fairly markedly.
Women, who are using libre, ketoconazole, which can be being advantaged to the women who were experiencing enter genic side effects in particular.
Whereas debt does not appear to happen.
With as Teresa therapy in fact, with this Teresa there may actually be an increase in androgens.
Which in some women mainly too.
Worsening of there.
<unk> side effects from the Cushing. So these so the physicians we've spoken to see that as an important potential differentiator.
The gender gender differences between the drugs.
Otherwise I think one other things we've heard is that the experienced with this Theresa. This is relatively new note no single physician has treated more than.
One or two patients with it so the jewelry remains out on what the ideal patient for that drug is going to look like.
We do still believe and Scott can comment on this debt.
Core lab is going to have a place.
In therapy, most likely.
As a first line medical therapy.
And we think particularly in women.
Who are having androgenic side effects or who are concerned about those.
Would be good candidates. So Scott did you want to.
For further details.
Yes, I think just building on what Fred said about as Teresa I think our research confirms a lot of what Fred mentioned I would I would add debt a.
A lot of physicians give us feedback on the dosing titration being a little slower than expected as Fred said.
There aren't a lot of physicians, who have a large number of patients on but I think it's fair to say that day.
Many havent reached perhaps perhaps with the maintenance dose yet.
So it's taken a little longer to titrate them I think.
Our research would suggest that that's because there is some concern about adrenal insufficiency.
As Fred mentioned, so that comes out in our research I think overall, though the early use is.
Like the.
The work that we did in 2019 and our market research at its competitive profile with good efficacy and I think theyre just.
It's early days, where theyre getting their experience with it.
I think as it relates to the record level, we remain really confident in terms of the profile.
As you know we tested the sonics profile and where we are in the process of doing more work with the complete package, but I think at the end of the day, we believe that the.
Record live offers.
<unk> differentiation given the unmet need that we've discussed.
Certainly what resonates I think are a few things one is it supported by.
<unk> potentially if it's approved two positive phase III results steady results indications abroad that.
And that resonates well with physicians.
Certainly the ante as USC.
Troll cortisol control I think by and large whether it's our formal market research or somewhere and by our advisory boards physicians recognize that they see good.
Clinical efficacy from.
The trial design is the ability to monitor.
<unk> is clearly important certainly versus some products where that may not be the case.
I think the secondary endpoints in particular cardiovascular the right endpoints resonate well and I think Fred also said these.
Signs and symptoms in particular Angiogenic effects were recorded as maybe androgenic sparing that comes across in our researches very very important in particular for women. So at the end and lastly, but not not.
The least important they look at the safety profile of <unk> and see that it's well tolerated and there were no unexpected safety signals, which we believe could be a potential differentiator. So.
Those are those are some of the things that we're hearing in our research.
Great.
Thank you for that color and just going back on the.
I guess prior question in terms of.
The population what do you see as the low hanging fruit I mean would it be new patients coming on therapy.
For the first time would it be patients who arent well control what do you think is.
The area that youre going to focus on first.
Yes, I think we will get starts annabel with with both of those populations.
There the new newly diagnosed patient knew the pharmacotherapy patients.
Arent as robust as the patients who are not well controlled or who are experiencing side effects from some of the other medications and so I think you'll probably be more likely to see.
Not well controlled patients, but clearly we've been told that the newly diagnosed patients, especially women will be prime candidates.
Okay got it and then.
And any more time.
And given the competitive landscape I mean, we know that you've always talked about.
And pricing.
Within that or from drug comparable range of other.
Other.
Treatment.
Do you think you.
And you could think debt.
Rethink that given.
The increase in competitive landscape.
Yeah. Thanks.
We're not going to comment obviously for competitive reasons too much on what our pricing strategy will be.
But as both myself and Scott have said previously we expect to be in that rare disease pricing corridor.
We believe that.
Recall of offers.
Significant benefits to patients.
And.
Certainly will.
Have.
A pricing study done as we get closer to market and understand the external environment as well, but our plans continue to look inside that quarter and beyond that we're not going to comment at this point, but I appreciate the question.
Okay.
One last question if I may ask.
Can you.
Talk a little bit about the commercial infrastructure.
What youre thinking for all.
Opex per progression from here.
Yes, we're still working through that we do know that we're going to leverage our entire infrastructure today, there will be some ads.
Just in order to make sure that we're servicing the patience.
As well as we possibly can with for example, patient access managers will make sure that.
Where the proper access for those patients.
The sales force because we're going to leverage our current sales force plus there will be some average and we're still fine tuning that.
As we speak.
As for the Opex Rich I don't know if we've given a range on that.
No we haven't given a range, but added value and I spoke.
Last quarter, yes.
I would assume.
Investment in increased investment in commercial obviously as we head into the back end of the year as we've discussed before and Youll see a reduction in obviously kind of clinical and regulatory type expenses.
We head into the back end of the year as well just given the.
Reduction obviously in spend there given logics being wrapped up et cetera. So that's the way to think about it.
Great. Thank you.
The next question is from the line of Jonathan Holden with JMP Securities.
Hey, good morning, Congrats on the progress and thanks for taking the questions.
For more on the populations.
Do you have a sense based on your market research what percentage of Cushing patients are women with these androgenic side effects, who are on current medications and then also to the.
IP, you're expecting what percent or.
On metformin as well that'd be helpful to know.
So.
You want to talk a little bit about.
The market research and then Brad can comment on the met form in the piece.
Sure I think based on our market research, while we didn't get granular in terms of the percentage of patients or number of patients that experienced these types of side effects from from their treatment.
We do know and we did ask as you may recall, we ask physicians to think about the current set of pharmacologic treatment options and then.
We layered in future products, including.
Is theresa and and and record live in Cortlandt as well and I think that's the phase where those types of things came out in terms of the potential impact of the androgenic side effects and physicians being aware and certainly.
Keenly aware that that may be negative four.
They are female patients so while we don't know from the research the percentage.
We do know debt, it's clearly an area of opportunity and potential interest.
That physicians are aware of and certainly when they viewed the profile for future products.
I think that's where we got the feedback that this maybe potentially important differentiator for record lows.
So in terms of diabetes. So diabetes is one of the more common comorbidities associated with Cushing syndrome.
Our clinical trials program, we saw.
Prevalence of type two diabetes at baseline of between about $35 and 40%.
That does seem to be consistent with the literature description of a broader endogenous cushings syndrome population. So you can figure upwards of 40% of patients have type two diabetes.
At the time, they're diagnosed or shortly thereafter.
And of those a clear majority use metformin.
Our clinical trials program it was between about 70% to 80%.
Okay.
That's helpful. And then you were talking about Opex, a little bit earlier I was wondering if you could comment on how many patients are enrolled and how retention is looking at.
<unk>.
Pension is to roll those patients over to commercial product when that ramps up in late 2022 2023.
Sure.
In terms of specific numbers of patients I can tell you that we enrolled a total of 51 patients across all of our sites globally. The majority of those were in Europe.
At this point, we're not going to talk retention numbers, but.
I will say that the clear majority of those are.
<unk> enrolled in this study our intention is to.
Try to have patients.
Who are in the study at the time other marketing approval go.
Transfer onto the commercial product at that point.
But.
I'm not prepared to say at this point, how many numbers we're talking about.
I would not anticipate it would.
Good.
A large number of patients so again from what I just said.
In terms of.
Of the.
Optic study.
Progress is.
As I indicated before the study is.
Intended to provide at least three years of experience on the drug and so we don't anticipate having any data from the study until 2023.
There is a provision that if the drug gets approved prior to that time point that patients could be transfer to a commercial product earlier.
That's helpful. Thanks for taking the questions.
Youre welcome.
Your final question is from the line of Robert Gardiner with Craig Hallum.
Good morning, and congratulations on the quarter.
A question on COVID-19 are you guys still on track for a $34 million to $36 million range for 2021, and do you have any updates.
For today.
We are certainly robin and thanks for the questions believes that.
We are well positioned to achieve that guidance.
And so we're confident in that and certainly congrats to Scott and his team on a really good first quarter and really strong April so we feel good about that guidance.
As it relates to the caboose I T. Rich do you want to provide a few comments on that sure I'm happy to good morning, Robyn. Thanks for the question yes.
We continue to prosecute the state using our IP counsel as well as availing yourself of all means through the through the U S patent office, including the appeals process to.
Two to push forward our estate in terms of specificity around around that we expect to be able to come back to all of you in the second half of this year with a further update.
That's what where we're saying at this point in time.
Okay. Thank you and then.
The data and the publications that have been reported since your NDA filing are those.
Going to be included in your submission to the NDA So will all of the.
Data after that point be in consideration as well.
So I'm not going to comment on the specifics of what were submitted with the NDA except to say that.
We do believe it's a comprehensive submission and that the FDA will be.
<unk> with the.
Substantive information that they need to.
Make a decision in terms of our profitability.
Okay, great. Thank you for answering my questions today.
Thank you.
And I'm showing no further questions at this time I would now like to turn the conference back to John Johnson for closing remarks.
In closing strong bridges made significant advances towards its mission of serving the unmet needs of rare disease patient populations. We are pleased with the continued growth of <unk> on a quarter over quarter basis compared to the prior year and we remain confident in the potential to bring <unk> to market.
We are committed to working closely with the FDA. Following the receipt of the day 74 letter and look forward to having the opportunity to make a meaningful improvement in the lives of patients with Cushings syndrome.
With that I would like to thank you all for joining us today and for your continued support we look forward to updating you on our future calls thank you and have a great day.
Ladies and gentlemen. This concludes today's conference. Thank you for your participation and have a wonderful day you may all disconnect.
Yeah.