Q2 2019 Earnings Call
Ladies and gentlemen, thank you for standing by and welcome to the year event scientists fiscal 2018 second quarter financial results Conference call.
At this time all participants are in understand El Nino Bother me managements prepared remarks, we will hold the question and answer session at that time, you can ask questions by pressing star followed by the number one on your Touchtone telephone.
If you.
Hi, difficulty hearing the conference the spread sorry, I've been in Brazil for operator assistance.
As a reminder, today's conference is being recorded I like to turn the conference over to Ryan Kubota Executive Director of Investor Relations. Please go ahead mr. because OTA.
Thank you operator.
Thank you all for joining your best fiscal 2019 second quarter financial results Conference call.
With me today are four members leadership team.
Cancun, <unk> Chief Executive Officer.
As you know combo.
Accounting officer.
Well some killer.
Chief Medical Officer.
Our new Chief Financial Officer, Senior Vice President business development.
Today after market close we issued a press release containing detailed information on our quarterly results.
You may access to release on our company website.
Okay.
During our call.
Forward looking statements, including statements regarding our plans strategies clinical development.
And other treatments for your logic diseases.
Cautions at home or forward looking statements are based on our current expectations and assumptions, which are subject to numerous factors that could cause actual results could differ materially.
Certainly we advise listeners to review the forward looking statements disclosure in today's press release and the risk factor section of our Form 10-K , as well as a Form 10-Q .
Later, this week, but that said.
Now I'll turn the call over to our CEO .
Okay.
Thank you Ryan I my thanks to all of you for joining US today first I would love to what like two of them, Ryan Kubota or new head of Investor Relations Ryan joins us from Molina healthcare he looks forward to speaking with all of you in the upcoming weeks. This has been exciting quarter for your event, we achieved key clinical milestones.
For our away be development program for my background and now with the substantial financial commitment and enhance commercial support from the Sumitomo Dainippon pharma, we are in an optimal position for developing your of it into a leading specialty urology company.
Last week wave at pharma and Sumitomo entered into a definitive agreement for the creation of a broad sumitomo wave and strategic alliance, which upon close.
Will result in Sumitomo, becoming the new majority shareholder of your about Sciences.
In conjunction with the definitive agreement with Revana Internet also entered into an agreement with Sumitomo, whereby Sumitomo has committed to provide your event.
The following things first a 200 million low interest interest only five year term loan facility second certain minority shareholder protections third access to enhance commercial support.
Sumitomo you asked the franchise Sunovia and finally, I said, yes.
Profitability.
Yes.
No. The top 10, the Japanese listed multinational pharmaceutical company with an extensive history of innovation in drug development and commercialization.
We generated over 4 billion in revenue last year through the commercialization of several large pharmaceutical drugs in the United States, including the blockbuster drug Latuda.
We look forward to this promising new alliance with Sumitomo as we prepare for the commercial launch of my background, our new drug application or and D.A. filing at launch preparations for my background are well underway and we're excited to have the strategic support and proven commercial resources of Sumitomo.
This partnership should greatly optimize your that sciences commercial approach to the U.S. market with enhanced resources for drug distribution operations and managed care support.
Now regarding this quarter results, we achieved another pivotal milestone with the completion of the long term extension of the phase III Mpower study of my background for patients with overactive bladder. The study achieved its primary objective confirming that backdrop safety favorable safety and tolerability profile demonstrating further improve.
Treatment benefit of the key overactive bladder symptoms over the 40 week extension period.
In addition, we completed our pharmacokinetic pharmacokinetic study of my background as a crush tablet. These result results are expected to support labeling for administration of my background as a crush tablet in soft food a potentially significant advantage for elderly only be patients who have trouble swallowing.
With these key studies completed final preparations for our NDA for my background for patients with away be are progressing quickly for filing an early 2020 if not sooner.
Other important business highlights include initiation of part two of the phase III encouraged trial, which will assess both efficacy and safety of my background in men with only be BBH patient population for which no product is currently approved.
Enrollment a female patients in new ideas associated Domino pain trial with topline results expected in 2020.
Had finalization of the phase two way protocol for would be for Euro NATO two novel injectable gene therapy product, which is planned to commence patient enrollment by the end of the fourth quarter of 2019.
With that I'll turn the call over to our Chief Medical Officer, Dr., William Hague, Welcome Teller, who provide more detail to our clinical programs.
Thank you Keith as mentioned, we've achieved key milestones fairway B program combined they gone and continue to make excellent progress across our other clinical development programs. We are pleased to be important positive long term data come before two week extension of the Tracy and power so decide they grown in patients with overactive bladder.
This was a double blind Fortunately the extension of the 12 week placebo controlled phase two study.
It's a bit and cards patients from the in Paris study the seat blinded study medication.
I think owns 75 milligram or told timber deed four milligram extended release.
Those already and I think will alter the come to empower study remained on their respective treatment for totaled 52 weeks exposure and the placebo patients from the in Paris study berard randomized to either by the ground or charity portfolio do you think treatment period.
Of the 500 card patients and the long term extension.
Hi, guys person finished the trial and very high completion rate for two weeks study.
The primary objective the long term study with safety and Tolerability and the secondary objective with sustained efficacy USCYBERCOM reduction make curations urge urinary incontinence and urgency episodes.
We are pleased to report that in addition to demonstrating paperwork safety and Tolerability profile. The study should further improve creates a benefit of key overactive bladder symptoms.
The improvement from 12 week.
Onwards, with sustained over the entire for to be extension study.
Welcome to 52 week powered by Big on treatment reduction make traditions at week 52 was minus 2.5 episodes greedy has a baseline of 11.3 episodes.
Reduction and urgency episodes was minus 3.4 episodes per day.
From a baseline of eight episodes.
In addition by Baker demonstrated sustained efficacy for urge urinary incontinence. The most further some of the various extensive authority.
Urge.
Incontinence was minus 2.2 episodes between 52 can you baseline of 3.2 per day over.
Overall.
The total of 61% are they going to patients achieved 75% reduction of their baseline urge.
Incontinence at this out actually 52 weeks of treatment.
And 41% if I think on patients were totally dry maybe without incontinence at these notes after 62 weeks.
We're also particularly pleased to see that they could jeeps in America, the better efficacy that told charities active controlled it every time measured.
The adverse event profile the Fibig crown from the extension study was consistent with a 12 week in power Phase three study.
Adverse event rates for below 10% of interest and then paid for hypertension, what's at the rage.
It's the toll charity active control.
These data reinforce it beliefs that but thank god has the potential to be covered.
This.
In class oral only be treatment.
Plans for publication and presentation of both the appellate phase two study the long term extension results are well underway.
Recently, a detailed view of the CCAR results goods presenter globally at the international continents.
Society meeting Gothenburg, Sweden in September 2019.
Presentation took a long term dieter upside for future scientific meetings and 2020 .
In addition to the completion of the long term extension of Apollo Phase three study this quarter. We also completed the phase one.
Study on food effect with the final form.
Cardinal by Big World Cup, because milligram tablet testing of pharmacokinetic parameters.
If the tablet is crushed administration apples subs.
Study result will be used to support the proposed labeling presently station the five big long without a week's food and as a crush top look it's tough to food, which is an important potential benefit as many elderly patients have to come to swallow it.
Regarding our supplementing development program for CGI banker in men with me and Bernard custody type Acacia what BPH. The phase three courage program independent data safety monitoring board reviewed the safety data from 82 patients enrolled in part one of this trial at agreed that the study can Malibu.
Two part two of the trial, which.
In which over 1000 patients will be unfold.
Our to ask a phase three trial will know cisco's efficacy and safety. If I think all the lead be NBP age population a pivotal milestone as they're currently is no ft approved product specific he became took overactive bladder in men with BPH. The co primary endpoints are the reduction in the commission frequency and urgency episodes per 20.
Four hours.
Key secondary endpoints and reduction of Tory episode Awakening, I try to avoid posted symptom scores and safety.
In addition to the initiation of the part two of the Pasty Curt study patients compared to what have enrolled into the long term extension study, which will follow patients quite total exposure 62 weeks.
Regarding our clinical program RBS associated abdominal pain study continues to enroll female patients with I.B.S. associated pain, well, then randomize tied to 75 milligram of by big drug or placebo. The primary endpoint is 70% production abdominal pain intensity of the lessons when greeting skill.
At week 12 for ideas, B, which is IBX with diarrhea.
I responded to kind of subject because at least 30% decrease the worst abdominal pain compared to go we to baseline outrageous.
Secondary endpoints and come to global aging skill and safety protect your little bit backup that gets you to fixed assets to frequency of consistency.
We expect to report topline data from this study in 2020 .
Finally regarding our novel injectable gene therapy trial, 80 year old and I know two phase two eight project called preparations are proceeding per plan at the start up the study in the U.S., we expect to start patient goal on or the end the fourth quarter 2019.
Now I'll pass on to Christine quick financial update.
Thank you Cornelia.
[laughter] financial.
Right.
You can find additional information at our upcoming before.
Which will be filed later this week.
Research and development expenses.
He point 8 million for the second quarter at.
90.
Parents.
Point.
For the same period in the prior year.
And then second Florida.
Research and development.
Comprises cost related to clinical development.
Open label Phase I phase three trial.
Well.
Studies.
Page.
Domino pain associated with.
When comparing.
The decrease in R&D expenses, primarily due to a decreasing cost associated with the phase three.
Right.
Both the double blind an open label phases of this trial were completed in 2019.
General and administrative expenses were 7.4 million for the second quarter 2019.
Compared with 3.6 million for the same carried in the prior year.
The increase in DNA expenses, primarily attributed to personnel.
Including share based compensation.
No fees, such as legal and accounting commercial readiness.
And general operating expense.
Total operating.
For the quarter ended September .
Yes.
The increase of 2 million as compared to the immediate prior quarter ended June 32019.
Now.
[noise] inherent within that.
Four point.
Or $1.23 cents per share for the same period in the prior year.
At September 32019, the balance of total cash cash equivalents 67.8 million.
Now let me.
I mean.
Thanks.
We expect our cash.
To be approximately 20 to 28 million for core excluding milestone payments of 12.5.
Well become deal on filing of our Andy.
For the third quarter 2019, we expect our total operating expenses.
Milestone payments.
Ranger 30 to 32 million.
We plan to recognize expense for prepaid expenses that are associated with the phase three.
Yes.
With the additional 200 million.
From Sumitomo.
I'd be funded well.
21.
In addition, we expect.
Well continue to find your math science operating need.
Profitability.
Provide financial stability as we move forward.
And our additional development program.
And finally data we have passed the one year anniversary of our initial public offering we believe it is prudent financial planning haven't active shelf.
At the market facility or ATM in place.
Yes.
In the near term, we expect to file a 200 million form S. Three registration statement, which will include a $50 million 80.
And with that financial update I will turn the call back over to key.
Thanks, Kristina before I moved in my closing remarks, I would like to introduce you to Ajay Bansal, our new Chief Financial Officer, Senior Vice President of business development.
He brings over 16 years of finance business development, accounting and mergers and acquisitions experience and started up and larger biotech environment has a chief financial officer. He has led the growth and strategic capabilities for several leading innovative biotechnology companies as he also brings a very unique set of experiences to your bad.
Which I believe will enhance and strengthen our strategic business development and financing capabilities as it was like say if he wants.
Thank you Keith.
Well, she just delighted to be hit at Euro.
For me to be joining urine.
And the filing coming about coming up soon followed by launch preparations and now with enhanced financial resources that are disposal. The next two three years.
Exciting and critical in the evolution of your children.
Yes.
I'm impressed as I did want clinical data to date and I believe that has the potential to become a best in class therapy for patients.
Right It would be a part of this journey and look forward to interacting and meeting with several of you or the coming weeks with that let me turn the call Dr. Keith for closing remarks, they start there.
I'd like to reiterate our segments of the new alliance with Sumitomo, which should provide them.
Yes.
Yeah.
Providing access.
Yeah commercialization resources and other significant advantages as we prepare for the launch of my background.
In closing the second fiscal quarter of 2018 month key milestones across all aspects of our business and we look forward to several upcoming milestones that will continue to drive us toward the goal of developing your advantage way, leading specialty urology company. These up some upcoming milestones include filing R&D, a bride background and over.
Or active bladder by the first quarter of 2020 with the possibility of accelerating the file in the late fourth quarter 2018.
Initiation of part two of the phase three current trial, which will assess both the efficacy and safety of my background in men with away be NBP age.
Enrollment in our phase two IBX associated abdominal pain study with top line data read out expected in 2020 and started patient enrollment into phase two hey of our novel injectable gene therapy breakaway be you our own dyno too by the end of the fourth quarter of 2019.
With that I'd now like to open up the call for questions operator.
Yes group and ladies and gentlemen, if you'd have the question at this time. Please press Star then number one when you touched on telephone if your question asked and answered or even streamlines yourself from the can you. Please press the pankey.
Our first question is from me to borrow from Cowen Your line is open.
Hey, guys additional Dr. Richard Borough two questions from our and the first is then your expectations for a differentiation in terms of the labeling for background versus murmur.
Patrick.
So just like a better safety language and the second question is there given that the patent is set to expire I'm are better than 2023, how do you see that affecting uptake in the next five years enough generics are transferred at the market and possibly insurance coverage. Thanks for the question.
Sure I appreciate that and now let me try and take those off out one at a time I think.
First as it relates to differentiation, we actually think that our package insert will likely be differentiated from mira backdrop in a number of different ways.
First let me touch on the efficacy parameters I think first and potentially most importantly, we believe that the charts and our label will demonstrate two week onset of action either because our phase three study demonstrated my background efficacy two weeks and this compares very favorably favorably to mirror backgrounds, starting dose of too.
Many five milligram, which the package insert clearly states that takes up to eight weeks to work.
In our market research that has resonated very strongly with doctors and patients. Additionally, I think as we've discussed before based on our discussions with the FDA. We believe that we may be able to have some additional efficacy endpoints that no. Other only be drug has had in their package insert. This would include the.
Come up urgency given our strong performance in the phase three on the urgency endpoint I had also a responder analyses that many things the Cornelia was talking about how for example, the percent of patients that experience a 75% reduction in her urinary incontinence episodes things of that nature. So we think we'll be well.
Wretched from an advocacy perspective from a safety perspective, there too we think there will be a number of points of differentiation.
First and foremost or lack of drug drug interactions, particularly acute he thinks he looked at the mirror a background that label. They certainly do inhibit to de CIX and from our market research almost 40% of patients that are taking their bags are on drugs that are metabolize to be about halfway and therefore I guess.
During those patients do option, where they don't have to worry about drug drug interactions. We believe will be very meaningful for them as well. In addition, we have demonstrated that my background has no impact GTC, whereas mirror backdrop, we know supra therapeutic does have that impact on Q.
Okay.
And then finally just to wrap up our single convenient dose will certainly be an advantage versus.
I was dose titration and our ability to be crushed, particularly for the elderly patients that have problems swallowing, whereas we're back on can't be crush because it's an extended release formulation. So we think there's a whole host the reasons why physicians and patients will prefer a buyback Ron overmyer bedrock and and we bring.
Much look forward to.
Given that M.D.A. NN and getting.
Ruble as it relates to your question about the generic entry.
For MYR Bagger on right now we're uncertain whether that will happen at the end of 2023 or sometime in 2024 of the irrespective it'll give us about three years of marketing.
And before the generic.
And we think that's plenty of time to establish buyback Ron has best in class.
Be product. Additionally, as we've had discussions with payers evenly even as recently as last week. The payers did not view this as a highly manage category.
Communicated to us they would not expect to have stepped through of Mira background to use by bag Rod whatsoever. It's just not cost effective for them and to have to do that within their not within their plans. So all in all we are extremely excited at the profile. This emerged from a background in the studies in and how will be minimal.
Affectively position ourselves versus.
Previous question Great.
Great. Thanks, a lot.
Our next question is from Eric Joseph from JP Morgan.
I think your line is open.
Hey, good evening. This is turnaround for Eric I'm, just hoping you could elaborate a bit on the commercial support your upper receive from Sumitomo and if there are any specific aspects of distribution endorse salesforce that you are able to leverage and does this change your plan to 150 person sales force.
And.
Initial efforts to target, primarily urologists and long term care centers and then one other quick one I'm just a it's been a while since we've heard anything I'm just curious if there's an update for the I've, Yes pain study. Thank you.
Sure I appreciate the questions Turner so.
Still exploring and having discussions with Sumitomo you ask.
Business here, which is a sylvia.
They have a quite a large infrastructure.
They have demonstrated tremendous amount of success with the sales of or to die exceeding $2 billion.
We've talked to them so far about a host of different areas, where we may be able to collaborate with them.
Certainly on drug distribution is an important focal point for us I, probably well aware that smaller companies wholesalers whole Haas with very high wholesaler service fees.
Think now that weekend.
Beyond the Sumitomo umbrella, we can have access to their much lower wholesale service fees, which is actually save us a fair bit on gross margin.
Additionally, they've got a very large managed care footprint with a number of account managers and account executives. So we're discussing with them, how we could potentially tap into all of those relationships and also having the leverage of the for the full so noveon franchise in the U.S.. So we're having discussions with.
Payors.
And they also have a number of back office commercial support capabilities, as well, which were exploring with them and so all in all I think to the to the extent the people had concerns about our ability to launch as a small company I think the ability to tap into the Sunovia and Sumitomo infrastructure.
Should greatly alleviate any concerns that people have about a quote unquote small company being able to.
To effectively commercialized as well.
Guards to your question about Salesforce and southwest expectations.
We continue to expect it will have a 100 person urology field sales force Alibaba, we've already brought on a.
National sales director for that team has got tremendous experience in urology and we look forward to.
Being able to ramp up that fuel cell theme as we get.
For approval.
Additionally, we will have the 50, a person long term care sales force, which were.
Oh.
Yeah.
We are having some discussions with Sanofi and about is there a potential for a co promote I think it's too early.
Whether or not that's something that we could reasons.
On anything that we would view with them.
Treated at arm's length transaction.
To make sense for your event in Europe .
Yes.
For US you potentially due to do something like that and then I think your second question was in regards to RMBS pain program that program continues to to move forward.
With topline data expected in 2020 .
And so we're very much looking forward to provide a continued updates on that program as we continue enrollment there.
Thank you.
Thank you.
We have now the line of friends, who are on South, Florida, Kim from H.C. Wainwright your.
Your line is open.
Good afternoon, everyone. This is Ed remarks on for Rob I appreciate you taking the questions.
Just to go back to this sumitomo arrangement really on the earlier half after you've just got through the commercialization.
Just wondering if you lay out more of the spending plan for that initial 200 million and specifically just a few points.
Just wondering about that hundred million Hercules capital loan with that you'll pay that down with the 200 million.
Whether more funds will be devoted toward the launch or some of the clinical aspects that are still ongoing.
And then wondering also if there is a roof on how much capital Sumitomo is willing to commit.
But before you guys reach profitability.
Appreciate the appreciate all the questions. So I think in general are spending plan is unchanged and as Pristina said with with the 200 million loan facility, we expect that will be funded well into 2020 one.
We are as you'd expect certainly evaluating whether or not we should pay down the Hercules alone.
Back to that the Sumitomo and we'll be at a lower interest level and so I may make really good prudent sensitive to retire that but we'll need to.
To go through that with.
Our board and.
And all the economics associated with that deal in terms of more dollars on clinical programs or commercial.
We have always had a pretty full clat bull plan.
As it related to commercial spending and clinical spending so I don't really foresee any increase in spending on that front, but rather.
I see that said with the guidance for the remainder of this year.
On track with that guidance.
And then finally in terms of a cap on relative spends.
That obviously, we're still very early in the relationship.
So we are very appreciative that dates back to one of the company through profitability.
And.
We'll have to discuss with them as we move forward and.
Thank you Donna.
Exactly what that.
Oh, we obviously do want to continue with our business development efforts he wants to bring more product.
And continue to grow the pipeline of your bad so that will be.
Big focus for us as well as we get copper relationship with with Sumitomo.
Thanks, and I appreciate all those details.
Just a little bit on.
Sumitomo's strategy, what their commitment in interest level for indications beyond a way before if it back Ron and I have one more follow up.
Yes, certainly so I think if you put yourself in their shoes, they're looking at a 2 billion dollar patent Cliff and 2023 when left today goes generic.
So I think they're taking a very intelligent approach.
A number of different.
Time goals, so to say with products that can fill that pipeline gap and I think by better on is one of the more important products that they have the could potentially fill that pipeline gap for them. So.
So I believe that they're open to maximizing the full potential of I beg rod in all possible patients. Obviously, we're all very excited about Oh, a b, we're very excited to potentially be the first product ever approved for men.
That have always be and BPH.
Certainly to the extent, we saw nice robust treatment effect an idea. It's paid I think there would certainly be capital available to support that very large indication with a number of patients out there are suffering from Ivy us related abdominal pain.
It makes a lot of sense and then final question just on the long term 52 week data.
It does compare very favorably to the long term data from airbag, Ron I'm, just wondering when that full data will be released and whether it's going to be in a presentation or publication form and then when you're talking to prescribers about this long term data.
What does the degree to which they are indicating they find this long term superiority to told parenting.
More clinically meaningful.
Good you want to comment in terms of the publication plan and timing.
Yeah. Okay. Hi, this is Chris failure. So we plan to present the long term day, just first on the scientific Congress most likely.
The early second quarter of 2020 , that's will be followed by a full pay per publication sold off first three presentations.
You can expect it to be in the second quarter of 2020 and then publications.
And.
That will be the first one keeps the what do you take the prescriber question.
Yes, certainly and certainly as you'd expect the.
Health care providers that we shared a long term data with are very excited that data and I think you know as you simply pointed out.
The numeric benefit of my background versus full tarantin.
It's not lost on many of them, especially when when you consider the fact that would mirror background in there one study which included towards parity and mirabelle actually performed worse than told Tarantin out a number of those endpoints throughout the throughout the 52 week period. So we think it really supports the best in class.
Potentially.
Best in the area.
See profile of I beg, Ron and that's that look forward to move where big run through the the approval process with the with the FDA.
Alright. Thank you I appreciate all details and I'll jump back into queue now.
Thanks.
Next we have joon Lee from Suntrust Jimmy's Your line is open.
Hi, Thanks for the question and congrats on becoming part of the seat or family.
As you mentioned the starting dose for MYR background is 25 milligrams.
What's the typical steady state those for a minute background is that eventually end up being 50 or 75 milligrams and how does the efficacy at a hard to compare with.
Five milligrams.
My background and have about thank you.
Yes, so if you take a look at.
Give you the data in terms of what the mix of there being a big run the business is it's about 40% to 45% 25 milligram.
And the remainder being 50 milligram, so almost half of the market. There is on the on the lower dose.
It doesn't wind up progressing iron.
Or is potentially.
Or just.
Well in office therapy, there starting on that smaller ddos and not getting.
And not getting the release that they want.
And so.
For the second part of your question about comparing the mirror background 50 milligram data with my background 75 milligram data there if you look at.
He is between Mira Bagger I've asked do cross study comparisons to my background, which certainly has certain limitations you will see that the relief provided by bag, Ron how to numerical.
The American base is actually higher than what we're seeing with my background.
We're seeing with their Meg Ryan and so I think that relates to the last question that was asked looking at alternative is an active control and why we're so pleased that we were able to.
Be numerically better than told parity that.
At all time points in the 52 week I should say.
So the patients who don't get relief from 25 or.
Maybe 50 milligrams of bank, Ron did do physicians typically explore higher dose as tolerated or.
And how many patients actually tolerate the higher dose if that is something that physicians trying to do.
Yeah I think.
Our research suggests is that you think that the communication between the patient physician is better.
Hi.
So the patient.
Milligram dose they maybe as a sample.
Yes.
They wind up not getting the relief that they were hoping for.
Dr did fully prepared than what to expect.
Hope themselves and then many of these patients.
You know better on very early in the treatment cycle.
A large percentage come off within three months and so we think that's a huge opportunity one to pick up those mirror bagger on failures and all those patients that are coming off within.
Rob remote area, but also why why start with a sub therapeutic dose of another product that inhibits he said taski concerns.
Doesn't work fast.
Product that works fab doesn't have any concerns and doesn't have any cuties PC concerns and so we think that the.
Sorry.
Yes.
Ones were once by better.
Well.
For sure.
Great and then.
I totally understand that it's just tough the good housekeeping to have a shelf space, but what would be to use.
For that $20 million in the shelf and $50 million an ATM given that you have a low interest that 20 million dollar loan from Sumitomo. Thank you.
Yeah, the current time.
We just think in our audit committee believes that its just good prudent financial planning.
You never know what May happen, you may want to Opportunistically take advantage of funds that are available out there.
So lastly, we would want to do is not been a position where we could.
Take advantage of capital market that they were strong and onboard thought that they were worth tapping into.
Her time, obviously, we're very happy with the 200 million that we've received from the Sumitomo and we'll just continue to monitor market conditions stock price things of that nature as we as we move forward.
Great. Thank you and congrats.
Much appreciated.
Again, ladies and gentlemen, if he has a question at this time, Please press star and the number one on your Touchtone telephone.
We have again the lineup brighter I'm, so sorry, Jim from H.C. Wainwright. Your line is open.
Hi, guys had remarks here. Thank you again for taking the follow up.
Just two quick one for me.
Just making sure the stability testing data is still the major gating factor for that indeed mission and that it still on track to be completed in December .
That is correct and it's kind of like watching paint right now.
As a way to get to that data next month.
I can imagine yeah.
And then just finally on a broader level in terms of the only be market growth seems to be grown pretty strong in considering some of the details that you talked about with.
Sales of patent cliff they seem to backing out of active promotion on your Patrick So I'm wondering if you could talk about.
What's really driving this consistent way be market growth.
And.
What I'm sorry, if patients are actually switching to be to three medications would the messaging forfeit micron focus more on a differentiation differentiation versus mirrored by Ron word there still be need to have a broader conversation around the benefits a bit of three medications over stuff like the internal energy.
Yes.
It's a really good question.
And I think whats important to note is that as you look at the market fill a large majority of the market, our Eddie corner objects and as we've talked about in the past, there's more and more emerging literature about the concerns of any corner gx their impact on cognition.
Certainly the increased risk of dementia from the use of those anti corner addicts. So as we sit back and and as we think about where the biggest market opportunity is the biggest market opportunity is not going head to head with the sellers and trying to fight for those patients that are going over to a beta three we think when they make that choice.
Obviously, we want to position by background as the best choice.
But we really think that the big opportunity as conversion of those patients Ron Eddie corner projects over to a beta three and so if you look at historical class situations, where you've got an existing class mechanical allergic them at a new class like the beta three is typically when you see second in class product to come out how you see.
I think a large expansion in that class of products. So our hope is that the beta three glass expands we're on the market as well and that we are converting more patients from any corner takes over to beta threes than we are.
Taking patients from Mira background, and we think quite frankly that does represent a win win.
For both us and Astellas and the end for patients because beta threes are better and safer in our opinion than the corner dates for these patients suffering from maybe.
Understood. Thanks, again for taking my questions.
Again, ladies and gentlemen, if he has a question you need to press Star then number 100 touch telling telephone.
They don't have any further questions at the moment.
That brings us to the end of question and answer session of today's call I'm not trying to pull over to Keith Kathryn.
For closing remarks.
Thank you very much operator, and we appreciate everybody joining us for our call today and look forward to providing you with continued updates on our progress appropriately.
Ladies and gentlemen, this concludes today's conference call. Thank you for participating you may now disconnect.