Q3 2022 TG Therapeutics Inc Earnings Call
[music].
Greetings and welcome to the TG Therapeutics third quarter earnings Conference call. At this time all participants are in a listen only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance. During the conference. Please press star zero on your telephone keypad as a reminder, this conference is.
Being recorded it is now.
Hello pleasure to introduce your host Jenna Bosco Jenna you may begin.
Thank you welcome everyone and thanks for joining us this morning, I'm, Jenna Bosco and with me today to discuss the third quarter 2022 financial results and provide a business update are Michael Weiss, our chairman and Chief Executive Officer, Adam Waldman, Our Chief commercialization Officer, and Sean Power, our Chief Financial Officer.
Following our safe Harbor statement, Mike will provide an overview of our recent corporate developments Adam will provide an update on our commercialization efforts and Shawn will provide a brief overview of our financial results before turning the call over to the operator to begin the Q&A session.
Before we begin I'd like to remind everyone that we will be making forward looking statements within the meaning of the private Securities Litigation Reform Act of 1995. These forward looking statements include statements about our anticipated future operating and financial performance, including sales performance projected regulatory milestones clinical development plan.
<unk> and expectations for our marketed and pipeline products TG cautions that these forward looking statements are subject to risks that may cause our actual results to differ materially from those indicated and factors that may affect TG therapeutics operations include various risk factors that can be found in our SEC filings.
In addition, any forward looking statements made on this call represent our views only as of today and should not be relied upon as representing our views as of any subsequent date, we specifically disclaim any obligation to update or revise any forward looking statements. This call is being recorded for audio rebroadcast on Tg's website at Www Dot T G.
[noise] therapeutics Dot com, where it will be available for the next 30 days.
Now I'd like to turn the call over to Mike Weiss our CEO .
Thanks, Jennifer and good morning, everyone and thanks for joining us on the call on.
The third quarter of 2022 was a very productive time for T. J is the team really came together to execute on our prelaunch commercialization plans as we've mentioned previously our.
Goals for this year are to work toward an FDA approval for a man in relapsing forms of multiple sclerosis and to be prepared if approved the launch early next year.
We've guided that our goal was to dedicate the resources necessary to achieve these goals and minimize or eliminate all other expenses I am pleased to report that our streamlining and focusing efforts have been extremely successful in reducing our overall burn while reserving our resources to support the potential approval and launch who talks map.
Sean power, our CFO will join us shortly and provide some additional details, but our burn for the third quarter was approximately $34 million down substantially from prior quarters I am proud of the hard working team effort that was required to realize these cost savings while ensuring we we're all well positioned financially for the potential.
Logical but talks about.
Also just a few minutes Adam Waldman, our chief commercialization officer, what did you want us to provide more details around our launch planning progress, which from my vantage point it seems to be moving along quite nicely.
We believe that if approved botox map has the potential to play meaningful role in the treatment of multiple sclerosis, and we remain committed to offering patients a highly active treatment option with the convenience of a one hour infusion administered every six months following the first dose.
With that let me remind everyone of our phase III.
Program that is supporting our BLA submission for Botox map in relapsing forms of my best also referred to as RMS.
The ultimate one and two phase III trials evaluated who could talk to map compared to tariff solidified enrolling approximately 1100 patients across 10 countries and were led by large Dr. Large statement of Stanford University.
As noted in the past both studies met their primary endpoint protection.
That's gonna have treatment, demonstrating a statistically significant reduction in <unk>.
I realize relapse rate.
Also referred to as are our compared to tariffs where to buy it.
In addition to the positive primary endpoint results, we've had the opportunity over the past year to present several different sub analysis. This dataset, which we believe continues to show an encouraging profile.
Talks about for the treatment of patients with Rms.
Most recently, we had the opportunity to present five additional exploratory datasets.
The 2022 annual Congress of the European Committee for the treatment and research in multiple sclerosis.
And then you purchased extras.
The team engaged with numerous kols during this meeting and the feedback we received around the profile talks map was highly encouraging and we believe the data presented further support the potential for <unk>.
Got to map to treat patients who are a mess if approved.
Yeah.
On the regulatory front.
As in the past, we will not provide color on any interactions with the FDA, but we would like to provide an update on where we are in the process with less than two months. The target action date of December 28 2022.
We can confirm that we have completed the late cycle meeting and labeling discussions have recently commenced.
We remain hopeful that a little bit talks and that will be approved and if approved we will be excited to make oops. That's another available to the many patients RMS that are in need of additional treatment options.
I will also mention that our efforts with the MAA for EU approval are moving along and from a timing perspective potential approval could occur in the second half of 'twenty. Three we are still assessing the go to market strategy in Europe , and we continue to evaluate whether to go it alone or whether you partner ex U S.
So with that let me turn the call over to Adam Walsh, our chief commercialization officer to share some thoughts on our preparation of those.
Past quarters past quarter as well as his thoughts on the potential commercial opportunity and plans for botox and map in RMS Adam.
Thank you, Mike and good morning, everyone.
I'm excited to provide an update on our commercial activities as we have made considerable progress over the last several months on our preparations for the anticipated who will talk some app launched in relapsing forms of multiple sclerosis.
And that is a debilitating chronic disease that can have a significant impact on the quality of life of patients and their families.
CD 20 class has truly transformed the way M. S is treated and physicians believe that using these agents early may significantly impact the natural course of the disease.
Approximately one of every two patients starting a new therapy will go onto CD 20.
In fact market data shows that in the second quarter of 2022.
There was the highest share of CD 20 usage, we have seen since these agents were launched.
This is a large and growing market and based on our market research, we believe a botox or map has the potential to capture meaningful market share market share.
We understood from the moment, we started working in this space that one of the keys to success would be to hire a team of experienced professionals with a deep knowledge of the landscape and strong relationships across the Ms community.
To that end, we have been methodical in how we have hired our commercial field teams.
And at hand selected people that fit our target profile.
Over the last several months, we have significantly ramped up our hiring adding critical field based customer facing roles in sales sales leadership and access and reimbursement support or.
Our hires on average have 12 plus years of M. S industry experience. They joined our previously hired field based regional marketing team as well as our payer and medical teams, which have been engaging providers and payers field for the last 12 months.
At this point, we have met our internal hiring goals for our field based team members and we will be working over the next several weeks to finalize the hiring and training of these teams to be prepared for launch.
Our team also knows how important it is to get this drug to the patient community and is working hard to ensure we do everything we can to provide access to bill talks about once approved.
One of the biggest frustration here from physicians and practices in general is navigating the process of access and reimbursement for therapies. We have therefore placed a significant emphasis on ensuring that the process to axa supercuts and that will be as seamless as possible.
I'm extremely proud of the progress our team has made over the last several months building our capabilities in this area.
First from a payer perspective, our national account teams are doing a great job engaging with national and regional payers for over the last year feedback on the clinical profile of <unk> has been positive and we do not foresee any major issues with reimbursement.
However, with any new product peers will need to work through their processes over the first 90 to 180 days post launch.
Second we have made considerable progress understanding the institutional formulary process.
And have plans in place to work with the key M. S centers of excellence to include a botox amount on their formularies as soon as possible.
Third we know that the majority of MF patients will opt into patient support programs and this and that this is another critical component of ensuring access.
We have worked very closely with key customers to build what we will believe will we believe will be a best in class patient support program and we are on track to be ready to launch this program alongside a loop botox a map once approved.
Lastly, we have now hired an experienced field base access and reimbursement team that will work with accounts to facilitate access to lots of them.
In summary, we have made tremendous progress on building and strengthening our commercial capabilities over the last 12 months, which has accelerated over the last few months.
As we ready the organization for the possibility of new blocks in mouthwash.
We have built an incredible team, which we believe is as experienced if not more so on a pound for pound basis than any M. S team in the industry.
These teams are ramping up their activities actively engaging key participants in the MS community Kols community neurologist payers and advocacy groups at conferences advisory boards and other engagements our confidence continues to grow at the feedback on <unk> profile and the way we have built our commercial team has been very.
Positive across the board.
We believe this launch represents a significant commercial opportunity in all of our attention focus and commercial resources are aimed at making this a success. We continue to move forward with a sense of urgency and purpose as we know will be tuck them up if approved will be an important new option for.
For patients managing this debilitating disease.
And with that I'm going to hold it handed over to Sean.
Thank you Adam and thanks, everyone for joining us this morning.
Earlier, we reported our detailed third.
Third quarter 2022 financial results, which can be viewed on the investors and media section of our corporate website.
For today's call I'll touch on a few highlights from the quarter, beginning with our cash position.
We ended the third quarter with approximately 198 million in cash cash equivalents and investment securities.
That coupled with the additional capacity available under our Hercules facility upon <unk> approval you.
We believe will be sufficient to take us in to 2024.
We are pleased to report that our burn for the third quarter of 2022 came in under our previously guided range of $45 million to $50 million.
And even in approximately 34 million for the quarter.
Also well below prior quarters.
As Mike said as the result of our determined cost saving cost savings measured and are focused preparations for the upcoming launch of <unk>.
Along with some timing differences, which we will incur in future quarters.
Our GAAP net loss for the third quarter of 2022 was approximately 36 million or <unk> 26 cents per share.
It was a decrease of almost $50 million from Q3 of 'twenty, one where we saw a net loss of approximately 86 million or 65 cents per share.
As compared to the prior year quarter. The decrease was driven by across the board decreases in R&D and SG&A, primarily due to a streamlining of our oncology operations and the shift in focus or M. S development and launch preparation efforts.
The GAAP net loss for the nine months ended September 30 of 2022 was $145 3 million or $1 eight per share compared to a net loss of $254 8 million or $1 93 per share for the comparable quarter in 2021, representing a deep.
The net loss of more than 100 million period over period.
In terms of what we expect moving forward.
Our burn for the fourth quarter of 2020 to be between 40, and 50 million, which we believe leaves us well positioned through the anticipated M. S producer at the end of the year.
With that I'll now turn the call back over to the conference operator.
To begin the Q&A.
Yeah.
Thank you we will now be conducting a question and answer session. If you'd like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is on the question you May Press Star two if you would like to remove your question from the queue for participants using speaker equipment and may be necessary to pick up your handset before pressing the star keys.
One moment, please while we poll for questions.
Thank you. Our first question is from Ed White with H C. Wainwright. Please proceed with your question.
Yes.
Good morning, Thanks for taking my questions.
So just on the.
You had mentioned the E M a timing as the second half of 'twenty three.
How do you describe can you describe the opportunity in Europe , what is the market like what are your expectations for it.
And then as far as partnering.
If you were going to partner when should we expect to hear something like that would that be prior to approval do you think or that would be something that would come after approval.
Hey, Thanks for the question.
So you know the EU opportunities interesting I think do you currently probably nervous about 20 ish percent.
The overall.
Market opportunity for CD twenties.
So that's so too.
A.
Reasonable size.
Piece of the market, but it's not obviously a a a large portion so it's not a high focus for US most of that in terms of dollars is that is in Germany.
The other countries, obviously, there they're in there, but it's a lot less so.
As we think about the opportunity and we think about potentially setting up an organization.
Europe , I think it probably would be.
Germany focused and then we'd spread out from there if we get down the road.
In terms of timing of a partnership.
You know were not running any any timing, but you know it could happen before after we launch there are it's always you know.
Always very speculative, but I would say again, it's if our if our ultimate decision as to partner to launch then.
Invariably what happened in advance.
Okay, Thanks, Mike and you've done an incredible job on cost cutting I'm, just thinking about how how should we.
Consider R&D expenses going forward.
You gave some guidance on SG&A being up in the quarter.
What are the R&D opportunities, how should we be thinking about that and and how should we be thinking of the expense for that line.
Yeah, I would expect that the R&D expenses will continue to go down again, we still have oncology trials that are just hard to completely shut down.
We were carrying some of those expenses still but as they continue to go down we will probably not probably we will be starting additional.
Studies around Uber talks about a bit of a mess and potentially outside of that but.
So I think it continues to go down for the next quarter or two but maybe Sean wants to chime in and then it probably starts to creep back up in the second half of next year.
Charter is that about right or any other color.
Yeah, No I think that's fair Mike.
Okay, great. Thanks for taking my questions.
Thanks, Ed.
Thank you. Our next question is from Chris Howerton with Jefferies. Please proceed with your question.
Great. Thank you so much.
I just wanted to ask a couple of questions on kind of the expected commercial dynamics, you know alpha tumor mab has been doing a little bit better in the launch. So I was curious how you were thinking about the differences between dosage forms in the CD <unk> and maybe.
If there would be some differential patient or physician targeting between those two so that that would be one question and then the second question. I have is just kind of housekeeping thing is looking at our model. It what is the latest kind of IP expiry that youre expecting Mike and team. Thank you so much.
Sure.
So on the IP side.
I think the patents for the talks about the basic patents are.
With patent term extension.
32 33.
Assuming there is an approval will be entitled to.
12 years market exclusivity for biologics that would actually put us into.
25 are very very late 'twenty four I'm, sorry, 30, 34 late 34 or early 35.
For the 12 years, sorry, sorry about that.
And then we do have some other patents we haven't spent much time talking about that could go on for another 510 plus years. So we think we've got a pretty good runway.
With the patents with the biologic exclusivity and potentially with some other patents behind the scenes.
I will I will briefly.
Briefly answer your first question on the Adam discuss it but you know it's interesting in terms of the dosage forms that it's really become a somewhat to markets I think the physicians the prescribers.
Hmm.
We view these products somewhat differently in different settings in which they might want to use them.
Most doctors and most patients actually we heard yesterday and one of them one engagements that even those patients who are just not interested in dealing with their disease once a month.
But it does seem that the W has a nice role for patients who travel distances to get to see their M. S provide.
Provider and so yeah, we had projected early on that.
Hum.
Q would probably represent.
30% of the market.
And it does feel like that's where they're they're tapping out there obviously the overall market share.
You can use to grow because as you know there's a there's an accumulation effect as people come on and they stay on so but they're they're dynamic shares getting close to capture and I think it's between 25 and 30% of the dynamic share.
And that's kind of where we see the market. So I think that's.
We believe it's going to continue to shake out at about 70% of the patients will continue to receive an IV PD 'twenty at about 30%.
We'll go with the sub Q.
Adam.
Please add some more color.
Okay.
I think he pretty much covered it Mike the only thing I would add is that.
So it does seem like the market with with consensus volatile. It does seem like the market has continued to expand.
Perhaps outside the centers of excellence in more rural areas, perhaps more general neurologists.
But what Mike said is it's pretty much exactly what I would have said.
Yeah.
Okay, and maybe just as a minor kind of follow up if you'll entertain it Adam and then Mike too of course.
Would you I guess, how are you thinking about targeting those physicians that would be more likely to prescribe <unk> versus <unk> I guess do you have that visibility do you think.
Yes.
Yeah.
Ill start biking looking at.
I think I'm at centers of excellence that have infusion capabilities I think community practices that have infusion capabilities.
<unk> would be.
Logical place to start and it makes sense in terms of where we think I'd be usage will predominantly continue to be.
And so that that that is where we believe the initial focus for us should be.
And I think the majority of a bulk of its usage is seen in those in those large Ms centers of excellence in these very large community centers with infusion capabilities.
Yeah, Thanks, and I'll add to that Chris.
I hope that you know when we think about you know the best or highest are alive for for US. Obviously, it's it's going after the sites that are that Adam's referred to.
The general neurologist has just been getting into a C. D Twenty's and that's I think been a.
A huge effort.
Both the Roche.
The Roche Genentech Novartis teams.
Get out there I do think again as Adam mentioned and they're pushing into the more rural environments. I think those are going to be.
Nice areas for something like a symptom where they may be far from their physician and general neurologists again, who don't have infusion capabilities might.
It might be an interesting place for for something like attempted but for us the vast majority of the business and the best part of the current <unk> business I think will close to 8% is still concentrated in those large centers.
Centers of excellence and large community practices.
Okay that sounds excellent.
A more efficient business model it sounds like too so thanks guys.
Yep. Thanks.
Thanks, Chris.
Thank you. Our next question is from Matt Kaplan with Ladenburg Thalmann. Please proceed with your question.
Hi, Thanks for taking the questions and congrats on the progress guys.
Thanks, Matt I just wanted to to take take Christmas question, a little bit more for can you comment on I guess roche's subcutaneous programs and Theyre higher high dose a program as well and how do you think that was a well will impact the market other than what you said.
Yeah. So on the first Adam you can you can chime in.
You know.
We don't know a ton about those programs.
Certain timing.
I think the sub Q could be available in the next two years give or take.
And then on the high dose, we we don't really have any good visibility into.
Into where they are with that on the other than to say that.
You know I think their hydro strategies is to try to comp off of our potentially perceived better activity.
The more.
Potent <unk> 'twenty.
So we'll see how that works out for them, but again I think it's going to take them a long time to get the material into the patient. So I don't know that that's a strategy.
Strategy, that's going to provide a lot of additional.
Our competitive advantages for them.
W side again, I think you know.
The jury's out I don't think were overly concerned about it and think a one hour infusion every six months.
Still an extremely convenient.
Way of delivering the product.
That's up to you know.
I think there are.
Issues with that that sub Q formulation I mean, it's been used.
There are other products some of which have been very successful others have been not so successful. So I think the jury is out on that and we'll see how it goes for them.
Okay, Adam any anything further any color.
Yeah, I think he covered it Mike.
I think we will wait to see what the actual profile of that looks like and what's required from a pre medication post monitoring.
That all adds time.
But what I think what's what's interesting is that we do believe convenience streamlining the experience does does matter in this market and it's an important aspect of.
The overall experience both from a patient perspective from a convenience, but also from an office perspective. So we believe convenience is important but we also can continue to believe that we will be best positioned for patients who want a quick one hour twice a year b cell therapy.
Okay.
And you mentioned that.
That you are in our plans for continued development of Botox Mab.
I know following approval.
Can you talk about your plans for P. M S. A progressive M S. A in the future.
Yeah. So we are exploring that area I don't think we have any plans to discuss today, but we've certainly been engaging with the kols to understand what the needs are and what they think would be a successful.
The trial design in that area.
Okay, and then last question I guess, maybe for Adam I guess following approval what will your commercial team look like in terms of the size of the footprint and.
From where it is now.
Yeah, I think about where we are.
We're pretty much.
In good position at this point as I mentioned in our prepared remarks, there we've hit our internal timelines for hiring.
I think what I've said in the past is that our footprint from a field based perspective is about 80 to 100.
People, we feel like this is as we were talking about with Chris There we think.
Somewhat of a targeted approach we think we know.
Where we have to go in order to get the business.
M S centers of excellence large community centers.
It's going to be our focus we think we have a team that will be more than adequate to cover that.
And where we're in a good position right now and we'll be ready for launch and come early next year.
Great great. Thanks, a lot and good luck going into December .
Thanks, Matt.
Thank you. Our next question is from Eric Joseph with JP Morgan. Please proceed with your question.
Morning, Thanks for taking the question.
Can you just expand a little bit on your.
Access strategy from the patient perspective, I'm, just curious to know if there's much opportunity to compete with broken ribs and cause symptoms when it comes to.
Co pays are borne by the patient and then.
We will also be curious to get your latest sense of how sensitive payers are.
To price.
And then finally, just on cash position you know Shawn noted being cat through 'twenty 'twenty four.
Just wondering whether you are considering any financing alternatives to support the launch perhaps a royalty monetization. Thanks.
Thanks, Adam you want to take the first question sure.
Yeah. Thanks, Eric I think we're going to compete very well from a patient access perspective.
As I mentioned, we've built a best in class patient.
Patient support program.
We will have all of the support.
Initiatives that that these companies have.
Specifically about a copay program, we will have a co pay program and.
And we feel we're in a good position to support practices and patients.
And then your second question was around payers and sensitivity to price.
What we've heard is that.
Payers are interested in and biting competition into the market.
They're looking for lowest net cost and I think they are sensitive to I would just say low low net cost.
And I think we've gotten feedback from them, we understand where the where they're at and.
Developed or an idea of how we want it priced us going going into the launch.
Yeah.
Great and in terms of cash position and alternatives financings.
Eric where are you know we're keeping.
All the doors open in terms of ideas of how we bought it continue to choose to add but we're not going to be in any rush.
To get we have plenty of money to launch on day, one and obviously the money into 24, so not an emergency situation, obviously, we're not overfunded, but.
Most of that money would be sitting in the bank anyway, why we're getting everything up and running so they were feeling quite good about the cash position, even though it may not look like a whole lot to others.
Yeah, we were we're expecting to drive some some revenues in the first year, which will also extend that 2024.
Burden number and we have plenty of options and yes royalty and modernizations or are on the table of course as is our other potential financings depending on.
The market conditions, when we when we get to the launch phase.
Yeah.
Hey, Thanks for taking the questions and also good luck into December I appreciate it thanks, Eric I appreciate it.
Thank you. Our next question is from May augment Tony with B. Riley. Please proceed with your question.
Hey, good morning team, Mr. Thornhill, causing me asking a couple of questions for Mike what are your expectations for the potential labeling interactions as we're getting closer to that but do per day and how.
The warning section could be differentiated from agreements for example.
Yeah. So thanks for the question. So in terms of we did disclose them earlier that.
The labeling discussions have commenced but that we're not going to provide any any further color. So I don't know that I have anything more to add.
And same thing as it goes to the.
For the second part of your question.
Okay, Great and then just on the recently I saw a report that came out just any of your kind of top line thoughts on how you're navigating through some of the payer discussions more broadly maybe for Adam as well.
Yeah, Oh, I'll lead off and I'll, let Adam take over but are they actually report.
We've obviously are reviewing continuing to review it will probably have some comments on it official comments at some point soon but generally speaking look I sure. His role is to try to.
Influence, how we priced the drug there is there was there was a clear reason why they put their report out before.
Before we launched them in the whole report was all about my opinion getting us to try to affect how we think about pricing.
As you know, we've always been thinking about coming in at a lower price point, so it's not.
It's not foreign to us the concept, but I think some of their analysis are skewed.
Skewed in certain ways, just to make a point, but I'll, let Adam maybe address the overall payer access environment.
Yeah, I think with regards to the ICU report specifically.
View is we.
We don't think it's going to affect our access.
And you know payers haven't really reacted to it.
And we feel good about the value proposition, we're bringing with <unk> mab and feel good about our payer strategy and what we're thinking about from a pricing perspective and feel confident as I mentioned in the in the remarks that.
We don't foresee major issues with reimbursement and coverage.
Excellent. Thanks, a lot for taking our questions and now about the Buck Phillips CFO .
Thank you.
Thank you. Our next question is from per car Agila wall with Cantor. Please proceed with your question.
Hi, good morning, and thanks for thanks for taking my question.
Congrats on all the progress so firstly a quick clarification. If you can remind us if there are any inspections left for the F. D. A.
Also if you could talk about your readiness in terms of stroke supply at lunch and I had a follow up.
Yeah. So.
Again, we haven't provided any color on that.
Section, so I'm going to pass on that question.
What was the second part.
Readiness in terms of drug supply at lunch.
Yeah, Yeah, we have a we have plenty of drug supply for launch.
We have a large manufacturing arrangement with Samsung biologics.
And we're comfortable with or without a lot supply.
Okay, and secondly, Mike you mentioned you presented the data at several times over the past few months to talk about what you're hearing from specialists on.
What really gets them excited about who believe some of the key factors and also what's the willingness to switch Niall depot mccreless. Thank.
Thank you.
Okay.
Sure. Thanks for the question so.
You know when we go around and talk to the physicians and I think our goal is to just present the data as it exists.
We think the data speaks for itself.
And what we find is that different clinicians will resonate toward different aspects of the dataset.
Some folks will look at the annualized relapse rate and although we.
We don't compare to other.
Drugs in the class or the drugs outside the class other than tariffs.
Carefully.
Many physicians will look at it and say well this is by far the best annualized.
Annualized relapse rate and I want to have the best for my patient and and they believe that this is the best.
Others will look at the data and they'll be impressed with the tolerability and speed in which we can deliver the.
The infusion so it's not just about the one hour infusion, it's about the consistency to deliver a one hour infusion and the tolerability.
Okay Vista continues to have in later lines of of infusion continue to have relatively high rates of of infusion reactions upwards of 20% to 25%, even as a third or fourth infusion so where.
We're we're down by the third infusion I think were around 5% or something so.
It's a I think tolerability is one people have resonated toward again, we don't compare we don't make the comparisons but the folks will do their own comparisons in their head.
And then the one hour infusion obviously from a.
Patient convenience standpoint, a practice convenience standpoint, a lot of folks will resonate to work towards a one hour infusion. So I think it's a it's a mixed bag. Our job is just to make sure we present, the facts and only the fats and folks will do their own it.
Internal assessments of how they view the data.
Thank you and looking forward to the update in December .
Thank you.
Thank you there are no further questions at this time I'd like to hand, the floor back over to Mike Weiss for any closing comments.
Okay, great. Thank you and thanks, everyone again for joining us this morning.
As discussed multiple times today on this call.
With the target to do food action goal date of December 28, our primary focus is and remains working toward an approval for <unk> for patients with relapsing forms of multiple sclerosis, and if approved being prepared to launch early next year.
Yeah, and if approved we believe all the touch them that could be a meaningful treatment option for patients with RMS. We believe treatment options are essential when it comes to treating chronic illnesses like M. S and we're committed to supporting the M. S community.
Again for joining us this morning and have a great day.
This concludes today's conference you may do.
Disconnect your lines at this time, thank you for your participation.
Yeah.
Yeah.