Q1 2022 Arbutus Biopharma Corp Earnings Call
Good day, and thank you for standing by.
Welcome to diabetes, Biopharma 2022 first quarter financial results and corporate update conference call.
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I would now like to hand, the conference over to your first speaker today, Liza copper Alley, Vice President of Investor Relations. Thank you. Please go ahead.
Thank you operator, good morning, everyone and thank you for joining <unk> first quarter 2022 financial results and corporate update call.
Joining me today from <unk> Executive team are Bill Collier, President and Chief Executive Officer, David Hastings, Chief Financial Officer, Dr. Christiane, PTO, Chief Development Officer, and Dr. Mike Sofia, Chief Scientific Officer Bill.
Bill will begin with <unk> Corp.
What update followed by Dr. Sofia, who will provide an update on our preclinical programs.
Casey will then provide a review of the company's first quarter 2022 financial results.
After opening remarks, we will open the call up for Q&A.
<unk> will be available to address clinical related question.
Before we begin we'd like to remind you that some of the statements made during the call. Today are forward looking statements, which are subject to a number of risks and uncertainties that may cause our actual results to differ materially including those described in our most recent annual report on 10-K quarterly report on Form 10-Q.
To be filed later today and from time to time and other documents filed with the SEC.
I will now turn the call over to Bill Bill.
Thank you Lisa and good morning, everybody. Thank you for joining US. We appreciate your continued interest and support in Arbutus Biopharma.
As you saw in this morning's press release with our first quarter 2022 financial and corporate update.
On track to deliver on multiple key milestones across all chronic hepatitis b on Corona virus programs.
In fact, we anticipate reporting data from four clinical trials that are evaluating the seven to nine or eight six during this year.
And importantly, as Dave will discuss later in this call we are well positioned financially with a projected cash runway into the second quarter of 2024.
Now before I turn the call over to Mike Sofia to run through the progress. The team has made in advancing our proprietary early.
Early research compounds.
I'd like to highlight some of the progress we've achieved towards our three pronged HBV strategy to provide a functional cure for chronic HBV infection.
As you know that creep from three pronged approach consists of suppressing S antigen, reducing HBV DNA and boosting the immune system.
Starting with our lead HBV compound 72 nine.
RNA therapeutics.
Clinical trials to date <unk> has shown a sustained reduction in S antigen and in some patients and increased HBV specific immune response.
To further assist this activity seventy-nine together with standard of clear standard of care.
Analog is currently being evaluated in combination with other approved or investigational compounds into phase Iia clinical trials with a third trial expected to begin enrollment shortly.
The first trial AVP seven to 921 is assessing the safety and Tolerability of seven to nine plus interferon and patients with nuc suppressed chronic HBV.
This trial initiated last year is continuing to enroll patients and is on track to report initial data in the second half of 2022.
The second trial is being conducted by assembly bio and is evaluating seventy-nine with assembly's core inhibitor that'd be cool deal.
Late in the first quarter Assembly reported that this trial was fully enrolled with data expected in the second half of 2022.
Third trial.
Seven to 922.
We evaluate the safety antiviral activity and Immunogenicity of <unk> therapeutic vaccine or placebo after administration of seven to nine.
In nuc suppressed chronic HBV patients.
Sites are being activated for this trial with plans to dose patients in the first half of 2022.
As we explore seventy-nine in these phase II clinical trials with the goal is to utilize these learnings to identify the best combination of compounds.
We can then explore in phase two b as we focus on developing a functional cure for HBV.
One last point I would like to make about seven to nine.
We anticipate reporting additional key data from the phase <unk> clinical trial.
Two nine double a one at a medical conference this year.
That data will include new owned treatment data for patients enrolled in cohort K.
HBV DNA negative and E antigen positive patients that received 90 milligrams of seven to nine every eight weeks.
It will also include additional data for patients in cohorts E G.
GE and Jay these cohorts.
First 60 milligram or 90 milligram every four eight or 12 weeks as well as long term follow up data for patients who completed.
Treatment and have discontinued seven to nine and discontinued nuc therapy.
We're looking forward to seeing the treatment discontinuation data as this will be our first glimpse into potential functional cure data.
Be it with a small subset of patients.
Now in addition on next generation oral capsid inhibitor AB 836 in combination with Nuc therapy.
Designed to eliminate viral replication and reduce HBV DNA.
Preliminary data that we reported last year from a clinical trial <unk> six <unk> hundred one.
<unk> hundred six is generally safe and well tolerated and provides robust antiviral activity.
We're on track to report data from this trial in the first half of 2022.
Now moving onto our coronavirus efforts, we're focusing on identifying and developing new antivirals small molecules to treat COVID-19, and future coronavirus outbreaks.
Our research efforts are focused on to a central targets critical for reputation across all Corona viruses.
<unk> protease NSP 12 preliminaries.
We're continuing to advance our efforts to nominate and NSP side protease or <unk> clinical candidate that we can move into IND, enabling studies this year.
We're also continuing the lead optimization activities for an MSP 12 viral polymerase candidates.
Finally, we continue to assess the potential opportunity.
<unk> with all oral PD Lone program.
I'm really proud of the progress that <unk> team continues to make in advancing these compounds and look forward to sharing data throughout the year.
I'll now turn the call over to Mike Sofia for an update on our HBV preclinical assets over to you Mike.
Thanks Bill.
<unk> space, we have two important preclinical assets.
Maybe 161, and maybe one zuma one both of which are currently undergoing IND, enabling studies with the goal of completing those studies in the second half of this year.
Starting with our oral RNA Destabilizer AB 106, one I'd like to walk you through.
Alrighty.
Stabilizer history, and how we selected <unk> 161, as our next generation compounds.
So in our quest to develop acute functional cure for chronic hepatitis b.
I believe that a small molecule RNA destabilizer could provide key piece necessary providing proprietary.
Oral treatment regimen.
Mystically <unk> stabilizers target the host proteins.
Five seven.
Each are involved in regulating the stability of HBV transcripts.
In doing so RNA destabilizer has lead to the degradation of HBV Rnas and thus.
<unk> reduced.
June levels and inhibit viral replication.
This activity are already the stabilizers are supported by several preclinical proof of concept studies in multiple animal models.
Our first generation RNA Destabilizer $84 two inhibited Eric.
<unk> production in vitro and in vivo using an AAV HBV mouse model.
We discontinued development of this compound based on peripheral neuropathy parties observed in the 90 day preclinical safety studies conducted in two species.
The setback, we still believe that the our HBV RNA Destabilizer mechanism of action is compelling and has the potential to lead to an oral therapy for patients with hepatitis B.
Our vigorous research efforts led us to the development of our next generation <unk>.
<unk> RNA destabilizer.
For <unk> 161 with <unk>.
Slides for this compound with a focus on our liver centric hematite to reduce systemic exposure of three compound and mitigate the peripheral neuropathy seem with the earlier compound <unk> two.
This was important but this new compound.
<unk> chemistry.
Compared to not only $84 two but also any competitor RNA destabilizer.
In addition, we wanted to maintain the robust antiviral potency as seen with the first generation <unk> stabilizers.
Maybe 161 was selected as the compound to advance based on anti viral activity seen in vitro, specifically, maybe 161 show potent anti viral activity multiple HPV cell models.
Active across all HBV genotypes maintain activity against nuc resistant variants. It was selective against HBV versus many other viruses and inhibits the production of multiple borrow protein products.
More specifically reduced serum S antigen and HBV mouse.
Mouse models.
Examined whether the sliver centric approach could avoid the peripheral neuropathy issued issues observed in our earlier compound $84 two multiple army toxicology and PK studies were conducted.
These show that AB 161 achieved a high liver to plasma ratio when administered orally and three species.
Our studies concluded that <unk> achieved a desirable.
And PK profile.
In in vitro in vivo non GOP safety studies, we undertook an extensive assessment of several development compounds.
With particular focus on agents have demonstrated the cleanest profile as it related to the peripheral neuropathy concerns.
To that end, we believe that 80 161 meets the high bar, we set and showed an improved safety profile compared to $84 two.
We are continuing to conduct IND, enabling studies with <unk> 161, including 90 day GOP studies in two species to further confirm our belief in our strategy to address the safety issues seen with 84 months.
Sure.
These studies are intended to give us confidence that we are a safe compound to move into clinical trials.
Now moving onto <unk> 101, our PDL, one oral small molecule inhibitor that has been our long standing strategy to combine agents, but reduce the HBV specific immune tolerance agent S antigen for agents that can further reawaken the immune system.
We believe we can do this with AB one zero warm.
The immune system of HBV.
Chronically infected patients is tolerable is to recognize the virus will impact itself.
To achieve a functional cure in long term HBV viral control, we believe that highly functional HBV specific T cells.
So our required however, HBV specific T cells become functionally perspective and greatly reduced in number during chronic HBV infection.
New checkpoints, such as PD, one PDL, one play an important role in the induction and maintenance of immune tolerance and in T cell activation.
Therefore, we hypothesized that one approach to reawaken HBV specific T cells, just to block the PD, one PD lone protein protein interaction and hopefully break HBV specific immune tolerance.
For this approach was observed in preclinical animal model studies, where checkpoint blockade in combination with other direct acting antivirals.
DNA clearance the sustained viral suppression.
Through our research efforts and preclinical work, we selected <unk> hundred one as a lead candidate based on in vitro potency immune restoration in vivo effort.
You can see selectivity and safety.
Enabling studies are currently underway.
We look forward to sharing more data on both of these compounds.
As it becomes available throughout the year.
I'll now turn the call over to Dave Hastings for a brief financial update.
Yes.
Thanks, Mike and good morning, everybody.
As I've mentioned in the past our key financial metric is cash and financial runway.
Our cash cash equivalents and investments was approximately $221 8 million.
As of March 31, 2022.
As compared to approximately $191 million as of December 31, 2021.
During the three months ended March 31 2022.
We received a $40 million upfront payment from <unk> pharmaceutical for the exclusive commercialization license agreement for AB 709 in greater China.
$15 million of gross proceeds from choose equity investments.
And approximately $300000 of proceeds from our ATM.
These cash inflows were partially offset by $23 $4 million of cash used in operations.
We expect our net cash burn between 90% to $95 million in 2022 not including.
The $55 million of proceeds received from Q.
And believe our cash runway will be sufficient to fund operations into the second quarter of 2024.
Now in terms of our <unk> transaction, we are accounting for the upfront and premium on the equity investment is deferred license revenue that will be recognized over time currently estimated at two years.
Based on labor hours expanded by our employees to perform our manufacturing obligations under the technology transfer and license agreement.
Including tech transfer assessing clinical drug supply.
So based on hours incurred we recorded $9 6 million of revenue in the first quarter of 2022.
In closing, we are well positioned financially to advance our mission to develop a functional cure for HBV and a treatment for COVID-19, and potential future coronavirus outbreaks.
And with that I will turn the call back to Bill Bill.
Thank you very much Dave and thanks to Mike Sofia as well operator, I think we can now open up the lines for question and answer session.
As a reminder to ask a question you will need to press star one on your telephone.
Do we draw your question. Please press the pound key.
Please standby, while we compile the Q&A roster.
Our first question comes from the line of Roy Buchanan of JMP Securities. Your line is now open.
Alright, great. Thanks for taking the questions I guess I'm going to start on the Corona virus.
Program that you guys are targeting Pan Corona virus approach for both debt.
<unk> preliminary so I believe can you can you just tell me if the preliminary shows the same level of conservation.
Cross the Corona viruses protease and then maybe just looking forward it too far a bit but.
You kind of view the larger opportunity.
Something more broad, possibly using primary care, possibly against the common cold viruses or do you think the larger opportunities potentially hospital use government stocking.
Mike would you like to take this.
Yes, yes, yes.
Yes, I'll answer the first part so so yes.
When we chose these two targets we chose them because both are highly conserved across all non corona virus was sorry.
The idea of both a pan coronavirus NSP Bogman protease.
And then one.
Paying for of ours for MSP 12, borrower payment rates are all still in play for us So yes.
Yes.
We are looking at.
General Pan Coronavirus strategy.
And fair to say Mike.
The approach would be to look at treatment first but it would be impossible to think about prophylaxis prevention strategies of Corona virus as well.
Okay great.
Just a question.
Question on that.
Look at possible certainly.
The <unk>.
Pfizer compounded reduce hospitalizations, but has now been shown not to have any effect on pre exposure prophylaxis, which is an area that.
We would like to enter into.
Yes, yes.
Youre not going to need ritonavir.
And maybe you will have better lung accessibility et cetera. So.
Looking forward to the next generation of compounds.
A question on 161.
It sounds like I'm not sure. If you guys have discussed this previously but it sounded like the conclusion is that the neuropathy is an on target effect is that correct.
Well I mean.
We haven't definitively proven that but certainly the data that we have accumulated to date seem to point to that and Thats why our strategy was.
It was developed as we described it.
We can give a little bit of liver centric agent that minimises peripheral exposure. We believe we can overcome the peripheral neuropathy concerns.
Okay, Great I think did you guys disclose the amount for the ratio of the liver levels to the to the serum.
No we have not yet disclosed that.
Okay, Great I'll hop back in queue. Thanks.
Our second question comes from the line of Dennis Zhang of Jefferies. Your line is now open.
Hi, good morning, Thanks for taking the question.
Two questions for me one on Hep B can you just please comment on.
The two phase two triple combo data that's coming at the end of the year in terms of number of patients and duration of treatment.
And what are the next steps you need to take to get the functional cure date I guess.
Typically have you guys decided one will patients be taken off the drug and.
And then my second question is around the protease inhibitor.
Can you talk about the.
Preclinical work.
You guys have done so far have you run biochemical assay that can measure policy and how confident are you in the potency profile of this drug versus tactful of it. Thank you very much.
Okay. Thanks for your questions Dennis Gaston do you want to take the first and then we will have Mike Sofia follow up on the protease.
Tom sure. Thank you hi, good morning.
So in terms of the two phase two studies one.
The triple ones one is in collaboration with our assembly.
That study now is fully enrolled.
60 patients and by the end of the Europe .
For some we will have.
On treatment data.
We will not happen.
Data at the end of therapy.
They've got a bit longer, but we will have but we believe its meaningful data on treatment in terms of what we expect I mean, it's a bit premature to say, but.
We obviously, obviously hope that the addition of the combination of all of this reduction will result in deeper on hopefully on treatment.
Lots of S antigen and.
Obviously, we will see whether that.
Happens or not.
In terms of the triple with interferon.
Relatively smaller study.
That study is enrolling and we hope to have some preliminary on treatment data as well by the end of the year.
And I think in response to your question about.
I mean, when we will stop patients.
Both studies.
Call for stopping patients.
More importantly, our phase <unk> study.
Already stopping patients.
Based on that criteria that we defined as.
As I mentioned before.
The criteria is multi factorial, but one of the important elements is the threshold of S antigen and we used less than the 100 to the site.
Patients.
Is ready to.
<unk> therapy.
And obviously, we're following the following those patients option nuc therapy.
Immunotherapy in trying to assess functional cure now one thing I want to point out that.
What we're doing with the phase one study.
Is not happening uniformly across all patients.
The study was amended to offer the opportunity for patients on the investigators to decide whether they wanted to stop nuc therapy, and obviously not everyone is opt into stopped.
Therapy, although they may meet the criteria. So I cannot define exactly how many patients we will be presenting in the future.
Alright, and then Mike on the <unk>.
Yes so.
To answer your question.
About the produce so we have a whole.
Battery of studies that we do so we do do by chemical.
Intrinsic activity.
Studies against Sars Cov, two but also protein and protein but also.
The <unk> from the other.
Or let's say a representative set of other Corona viruses that we do so we get the sort of central Penn Coronavirus activity.
And we are sort of in vitro wholesale and.
Infectivity assays that we studied the compounds again against not only Sars cov, two but against other.
Other.
Corona viruses.
We do.
A lot of let's say.
Biophysical studies to ensure that we understand how these molecules are binding.
We have.
Dun <unk>.
Krystal luxury structures, so we know where they bind and it helps guide us doing some of the.
Sort of lead optimization work that we continue to do with the compound.
As far as other Corona viruses are concerned or where our targets are.
Our main target is.
Sars Covid, two with preparing front of ours, but.
As we look into the future how it won't.
Essentially apply these agents to other.
Corn of ours.
Infections that are not our Sars Kobe.
Two.
Sort of certainly a possibility, but but.
We're focused on Sars COVID-19 two at this.
Current time.
Okay should we move onto the next question. Thank you Dennis.
Our next question comes from the line of Ed Arce H.
H C. Wainwright your line is now open.
Hi, Good morning, everyone. This promise here asking a couple questions for Ed.
So first question regarding the 739 till two combination study with <unk> 300.
Was.
Discussed earlier.
Can you go over some more details of the study how many patients should we expect European study and also any specific geographical focus there.
Okay.
Yes.
Sure.
So that's a phase Iia study, where we start dosing with 87% to nine and then patients get randomized into receiving.
<unk> 300 or placebo.
The <unk> 300 is just a combination of two different.
Vectors.
One is Jim banana. According HIV sequences, and then MVA clothing also HIV sequences. So.
This study is being done in collaboration with <unk>.
The study.
<unk>.
Has already achieved some regulatory approvals.
Different countries, but unfortunately, one of the countries that we selected to start this study was the Ukraine.
And as everyone knows obviously given the war.
We will not be able to.
Initiate screening and randomization in that country. So we are.
We are now shifting our focus into other jurisdictions we.
We have other countries that were already.
In our plan.
Are going to be screening and randomized in patients very soon but given the loss and the uncertainty.
With Ukraine. We are also trying to identify other other countries, where we can moving as fast as possible.
Got it.
Yes.
Thank you for hotels.
And then.
At least there was one of the questions earlier.
Regarding the two combination studies with 7% to nine that we expect initial data in second half.
At which point.
We begin to expect.
Decisions regarding which combination.
As more superior over than the others.
Therefore, it will be the one to move ahead future clinical studies.
Yes.
That's the intent.
So I don't know if guest on you want to add any additional color.
I think you can tell that.
We're working hard to try and assess the role at seven to nine can play in a variety of different combinations. So.
Once the data comes through will be in a much better position to decide to go forward, but that's fine.
Yes, I think it's a little bit of a challenging question.
On the date that really I mean.
The entre mandate that for example would be spectacular then one could eventually make a decision at risk.
One the size of the data is not clear cut then you have to wait longer to decide whether it's worth pursuing one path or the other.
So it really is.
He is a very difficult question to answer at this point I mean, the only thing I can say, it's going to be data driven.
Understood.
Thank you okay.
<unk> and look forward to the data in the second half this year.
Thank you.
Our next question comes from the line of Brian <unk> of Baird. Your line is now open.
Hey, this is Luke Harman on for Brian Thanks for taking our questions for the on treatment data.
And the combos here are there any other data points beyond that you think might be indicative of a durable off treatment effect, whereas that's really going to be the most informative data point for future plans and then on <unk>. One is there a chance we could see any of the existing preclinical data prior to the results of the IND.
Enabling studies or will that be reassessed once the IND, enabling studies.
Thanks.
Okay. So get done for the first one and then Mike.
Yes, great question.
It's very interesting.
Question, because I think if you look at the recent.
Final guidance on the HIV direct metal on bi issued by the FDA on April six.
<unk> continues to be the.
Endpoint.
So yes, we will.
Certainly play a very important roads central role in making decisions, having said that as everyone knows everybody is interested in other markers and we are.
Run those markers such as but not limited to HBV.
<unk> HBV RNA core related antigen. However.
Some of the recent publications there is a little bit of a mix.
There are literally about mix back regarding the value that these markers on treatment may provide in terms of predicting.
Adorable S antigen loss response or functional cure their wish.
So.
I mean, we are trying to include as many as possible.
Whether they are value.
Is going to be proven I can't really tell at this point in time, but certainly we're including things biomarkers beyond sandwich.
Yes.
161 question.
Yes. It is possible that we would present that at a scientific meeting.
Not too distant future some of the preclinical data on 106 one.
To demonstrate superiority to $4 two so.
That is a possibility of there are a couple of opportunities clearly.
Later this year.
Could provide that.
That disclosure.
That's it thanks.
Alright, thank you.
And next we have Roy Buchanan of JMP Securities. Your line is now open.
And I just wanted to I wonder if you could give us any.
Color on the potential on the presentations at Eagle I think you said seven abstracts quite a bit.
I assume theres going to be 7% to nine data there is it possible, we see the cohort K data there.
Anything from 106, one thanks.
Yes, good question.
Sorry that one to guests stone.
I think what we said in the press releases that we've had.
Kevin.
Submissions approved for presentation, but I think asked on you can get some additional color based on what is the look produced.
Okay.
Yes, sure so so alright.
If you go to.
Obviously, we need to be very careful we don't breach the embargo undisclosed and what is it that we're going to be presenting et cetera et cetera. So I'm sure. You appreciate that from our end, so, but if you or anyone goes to the ESO website today.
You can see that there is an orange.
Link.
And it will at least all of the abstracts that were approved in the first round.
Acceptances that ESR date back in December .
So and there you will see that.
Out of the seven that we announced five.
Are included.
In that list.
And those range from on that.
The abstract on.
Our PDL one checkpoint inhibitor.
And there is some there's one on the <unk> hundred six our capsid inhibitor and then there is three.
On <unk>.
<unk> is up 7% to nine immunology of 7% to nine on the cytokines et cetera.
And there is one on preclinical.
Activity.
Or durability of response.
S Irna's.
So.
You can read the vitals in anyone can read the title is let's see what the titles are all about.
So that's how much I can say I cannot really say, what we're going to be disclosing oriented in the recently accepted to other.
Presentations, which actually deal with <unk>.
<unk> Tonight.
Okay, Alright thats helpful. Thank you.
Our next question comes from the line of key K of Chardan. Your line is now open.
Yes.
Yes.
I guess, John can you update us.
The status of enrollment Port III.
<unk> hundred six.
Yes.
Well we.
We haven't disclosed that.
Status of enrollment.
Part III studies, but.
As you will see we are looking forward to presenting.
<unk> hundred six data.
Indicated.
Clothing at least three cohorts.
Okay. So the next the next data presentation for <unk>.
Six.
That will be two or three different patient cohorts in quarter three.
Bart.
Okay. Thanks.
I mean, sorry apart. It would include everything because we made we made that disclosure back in December on parts, one and two but.
Everything will be included.
Alright, three different dose levels for part three in the next data release.
Okay.
Yes.
Yes.
What was included in the.
Basically this is what is included in the design that we presented back in December .
So part one part two and part III would it be included in the presentation.
There are no further questions coming in at this time I am now turning the call back to Bill Collier CEO of Rbc's. Thank you.
Thank you and thank you for your questions everybody. Thanks for joining us this morning.
Obviously, we appreciate your continued interest.
And we especially look forward to providing further updates as we advance clinical and preclinical programs and report additional data from our seven to nine and 806 clinical trials at upcoming medical conferences and with that thank.
Thank you very much and operator, thank you for your assistance that concludes our call.
Thank you. This concludes today's conference call. Thank you for participating you may now disconnect.
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