Q4 2021 Ocugen Inc Earnings Call
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Okay.
Good morning, and welcome to the <unk> Conference call.
At this time all participants are in a listen only mode.
A question and answer session will follow the presentation.
If anyone should require operator assistance during the conference. Please press star zero on your telephone keypad.
Please note this conference is being recorded.
I will now turn the conference over to Karen Chelsea had.
Investor Relations and communications.
Sir you may begin.
Thank you operator, I'd like to welcome you to our conference call with me today are <unk>, Chairman CEO and co founder Dr. Shanghai, <unk>, who will provide a business update.
Chief Financial Officer, and head of corporate development Foundry, Superman, who will provide a financial update.
Earlier. This morning, we issued a press release, including a business update and fourth quarter and year over year financial results for 2021, we encourage listeners to review the press release, which is available on our website at www dot oxygen dot com.
Call is also being recorded and a replay along with the accompanying slide presentation will be available on the investors section of the oxygen website for approximately 45 days.
As always I need to advise you that this call will contain certain forward looking statements.
Such forward looking statements are subject to risk and uncertainty that could cause actual results to differ materially from expectations, including among other things uncertainties inherent in research and development of our product candidates.
Risks to our business related to the ongoing COVID-19, pandemic uncertainty regarding whether and when we will be able to submit a biologic biologics license application for <unk> to the FDA and whether and when we will receive regulatory approvals for <unk> in the United States or Canada.
These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission, including the risk factors described in the section entitled Risk factors in our quarterly and annual reports that we file with the SEC you should read carefully the risks and uncertainties described in today's press release as well as the risk factors.
Included in our filings with the SEC note that we will intend to file our Form 10-K by March 1st.
I will now turn the call over to <unk>, Chairman and CEO , Dr. Shanghai remove scenario.
Thank you Ken.
Morning, everyone and thank you for joining and we hope you enjoyed our families are safe and well.
We're here today to review with you some of the most recent activities and events that transpired in the fourth quarter of 2021 and provide some perspective on the full year.
2021 was a transformational time for oxygen, especially as we successfully progress two different assets within our portfolio.
Simultaneously, we expanded and diversified our team to match, our growing clinical development commercial and R&D needs. This was a year in which <unk> doubled down on what we call Green assimilation.
As we speak still a purpose and commitment to development with a purpose and great searching for new solutions enduring challenges.
Working to bring a new COVID-19 vaccine into U S and Canada to initiating a clinical trial for a game changing and the way to gene therapy that could potentially treat multiple genetic mutations with a single product.
Part of this team that has succeeded.
Our business partners to position us for so much more in 2022.
This slide highlights some of the critical milestones for vaccine in the later part of the year and into 2022.
First it's important to understand the context on the progress we made.
We have seen that the science has evolved and our nation's strategy. So changed today. The focus is on how to achieve ongoing protection and closing the gaps among populations who remained on vaccinated.
Just one year, so much has changed and oxygen I would work for correcting wrong or the months to meet this moment.
Our IND submission in late October .
U S submission in early November .
Work has paid off last week, we received clearance from FDA to initiate a clinical trial to support a biological license application or BLA.
Our clinical program will be a phase two slash III immuno bridging and broadening study we will provide more details over the coming months as the study progresses.
On the <unk> front I am pleased to say that there are discussions involving the data we have submitted including biotechs Immunogenicity data published in the Preprint server in late December 2021.
Our own Omicron research showing affleck units again, it's this variant and the database of more than 36 million teens vaccinated with co vaccine in India.
With more than 70% of margins looking for options based on our latest <unk>, Paul we know the need is great.
We will continue.
Aggregating the FDA.
<unk> shot by having evaluated by independent vaccine Advisory Committee known as <unk>.
Yes.
We recognize that many of you have been asking for ongoing regulatory updates and asking why the review can't move faster.
We hear you.
And we would note two things.
The first is that I am pleased with the timeframe it took to how the clinical hold lifted.
That took less than three months secondly is that getting to the critical juncture.
Significant confidential dialogue with the FDA, therefore, making public those details would have been detrimental to the review process. So once the review process starts.
Very little can be disclosed until there is clear guidance from the agency.
In Canada, we have played a comprehensive set of responses to health, Canada from follow up questions contained in what is known as a notice of deficiency.
Remember the collection is now under the new drug submission review.
Which will potentially lead us to full approval, we are following up with health Canada.
Determine next steps.
And speaking of Canada, there is nothing.
There is growing interest from local and provincial government officials about our interest in the manufacturing site.
Biosciences, OXXO Belleville, Ontario.
Positive discussions with leaders our center on the value of reestablishing manufacturing and R&D hub within the reason and for supporting the nation's contribution to innovation and public health.
One final note about co vaccine, we're pleased to share with you that we have made good progress towards establishing manufacturing capabilities at our partner jubilant polyester and spoken Washington.
And want designing a robust manufacturing process, establishing a means to transport active ingredient and straight adjuvant from India to the U S selecting primary packaging components.
Publishing quality control strategies that will provide additional assurance that the final product meets our rigorous FDA standards and can be safely administered to people.
The technology transfer is going well and we expect to complete qualification manufacturing grants at jubilant by the middle of this year now, let's turn to our modest layer gene therapy program.
As you know we submitted in November of 2021, an investigational new drug application for <unk>.
<unk> one slash two clinical trial for our Q4 hundred our lead candidate in the <unk> gene therapy platform for the treatment of retinitis pigmentosa, resulting from genetic mutations and not too easily and rhodopsin.
To date, the FDA accepted our application and our dose ranging clinical trial is now recruiting.
Details of the study are available on the National Institutes of health website clinical trials Darko.
Our next candidate our Q4 10 as IMD, enabling studies underway to support a future phase one slash two clinical trial.
And our novel Biologic, all Q2 hundred at transferring some stacking fusion protein that has potential to help those with diabetic macular edema.
BT retinopathy and wet age related macular degeneration is progressing well with IND, enabling activities.
We are on track to initiate toxicology studies in nonhuman primates.
So 2022 is off to a fast start.
<unk>.
Clinical trials for two product candidates with the data Readouts expected second half of this year.
Ongoing discussions with the FDA surrounding our pediatric U S submission for correcting.
Continued progress on the remaining assets in our portfolio.
I would like to thank our partners, whose efforts are key to our progress I'm very pleased with the progress we have made and know that we provide updates throughout the year.
I will now turn the call over to Sanjay.
<unk> fourth quarter and full year 2021 financial update.
Sanjay.
Thank you Sean and good morning, everyone. I will now provide an overview of key financial results for the fourth quarter and full year of 2021.
Our research and development expenses for the quarter ended December 31, 2021, $7 1 million.
<unk> to $1 6 million for.
For the fourth quarter ended December 31, 2020.
For the full year research and development expenses for the year ended.
December 31, 2021 were $35 1 million compared to $6 $4 million for the year ended December 31 2020.
R&D expenses for 2021 included a $15 million upfront payment to pilot biotech, but the additional right and license to go backs in Canada. The remaining increase is attributed to the continued investment in the development activities for <unk> and our ocular portfolio.
General and administrative expenses for the quarter ended December 31, 2021, or $7 5 million.
Compared to $2 2 million for the fourth quarter ended December 31, 2020 for the full year ended December 31 2021.
G&A costs were $22 9 million.
Compared to $8 million for the year ended December 31 2020.
Our increase in G&A expenses relates to increased infrastructure costs to support the growth of the organization.
Net loss was approximately $14 6 million or seven net loss per share for the quarter ended December 31 2021.
Led to a net loss of approximately $3 8 million.
<unk> net loss per share for the previous year's quarter ended December 31 2020.
For the year ended December 31, 2021, <unk> reported a net loss of approximately $58 4 million or <unk> <unk> net loss per share compared to net loss of approximately $34 4 million or <unk> 31, net loss per share for the year ended December .
31 2020.
Which included the in process R&D expense of $7 million related to the reduction of the carrying value of an asset that was previously recorded as held for sale.
Cash cash equivalents and restricted cash totaled $95 1 million as of December .
31, 2021, compared to $24 2 million as of December 31, 2020.
Earlier. This week, we raised net proceeds of $15 million before estimated offering expenses. This further strengthens our balance sheet and extend our runway.
That concludes my update back to you Ken.
Thanks, Sanjay and with that we will open up the call for questions operator.
Thank you at this time I would like to take any questions you might have first today and as a reminder to ask a question you May Press Star then the number one on your telephone keypad.
Can we tell you have glass you may press, the pound or hash key.
Please stand by while we compile the Q&A roster. This will only take a few moments.
Our first question comes from the line of <unk> Kumar from H C. Wainwright. Your line is open.
You May now go ahead.
Okay. Good morning.
We have another question from the line of Zack <unk> from Roth Capital Partners. Your line is open. Please go ahead.
Good morning, Thanks for taking my questions. Congrats on the progress I think the first question for me.
Thank you.
You can just comment on the details.
Around what was required to lift the clinical hold.
Good morning, Jeff.
Hi, good morning, Thanks for the question.
The clinical hold.
When you submit an IND.
Typically it takes it on time.
Is extremely busy too so many applications on the vaccine site.
So the typical questions if they have any clarifications they need and those are the questions. They asked and we accomplished so much it'll responses as I mentioned on our call and we were able to wrap up this whole process within three months, which is which is good considering in the workload of DHS and everything else going on.
Can you just clarify Phil was there any additional data needed what just a re analysis I'm just trying to get a sense of that.
Predict.
The outcome of that pediatric England.
No I think I mean.
Let me clarify on the indie holder.
Additional data was not there was a clarification questions, mostly willing to have to generate any additional data.
Coming to the.
Second question are you asking about pediatric use.
Yeah, I was just trying to kind of gauge.
But the pediatric and UA based on the <unk> you guys can just comment on that as well that would be helpful to the extent that you can.
Yeah. So the A&D is.
Before long term.
Illogical licensing application process and.
And we're trying to bridge the data.
From the U S demographic with the data generated in a large clinical trial in India.
That's the phase II <unk> III immuno bridging and broadening study we're embarking on.
Thats for BLA now the EUA was submitted.
Emergency use authorization, but pediatric population ages two to 18.
Based on the data generated.
By our partners.
Just on the immuno bridging trial, which bridges data to large scale phase II trial in adults.
So thats under active review by FDA.
And then as a follow up.
Without this question from investors and they just kind of wanted some clarity.
Whether the FDA committed too.
Providing the probe on the BLA.
Bridging study comes out positive, meaning that you will not need any additional studies beyond the bridging study to support the BLA approval.
Yes for the BLA approvals, but the two things I think have deal explore one is <unk>.
In mineral bridging typically you do that because you cannot keep on.
That will bridge with the large scale safety and efficacy trial typically you do that sort of other companies have done U S too.
And the uplift for pediatric population you bring to pediatric to large scale.
Efficacy and safety trial. Similarly in this case.
Part of the BLA, we are bridging.
On the mineral density side, that's kind of Virginia, two efficacy trials typically you all.
Also have to come back and safety study in the U S demographic based on trying to answer your car and that bridges. The safety safety of the population in the U S with the data collected from elsewhere.
So in addition to this immuno bridging trial, we foresee doing a safety trial in the U S. Population. So those are the two clinical trials required typically for BLA submission.
Okay great.
And just the last year.
This is perhaps still being determined that was just lagging.
Agreed upon sample size, but the bridging study offered the safety study and then where are you regarding next steps.
Need to be completed prior to the initiation of the break in the study for example manufacturing.
That means et cetera, and I will squeeze in my last one here and maybe Sanjay can just comment now with the recent public offering can you provide your updated cash runway.
Okay. So let me take the first few questions. The population for bridging study typically.
<unk>.
200 subjects.
For Immunogenicity trial, you don't need large population so that bridges neutralizing antibodies.
And then there are other antibodies are going to monitor in our case will be looking at not only spike there will also be looking at nucleocapsid protein others. Because this vaccine does provide a broadening immune response, unlike despite based vaccines and.
And the second question you asked is on safety clinical trial typically that requires.
More than what we need for emergency bridge and those discussions are ongoing with the FDA and once we have the final agreement with demand that number will be providing updates to the market.
Go ahead Joe.
Thanks for the question.
Regarding cash we were pleased that we did the financing.
This week it strengthens our balance sheet even further.
Additional capital will help with the investment in our programs and pullbacks in at the level of the ocular programs.
As you know we have <unk>.
For the pediatric use local vaccine pending at this point in time, so this potential depending upon how that progressed is substantial.
Near term revenues.
So that could obviously change our cash runway, but if we exclude that or any benefit from that and we have.
Without that we with the capital that we have raised we have sufficient capital to go.
Clinton.
First quarter of next year.
That gives us ample runway for investment in our programs and all the trials that we are contemplating to support the program.
Thanks, Sanjay and I will get back into the queue because I do have a question about AGA.
Sure. Thank you. Thank you Bob.
Once again I would like to remind everyone. If you wish to ask a question simply press Star then the number one on your telephone keypad.
Yes.
Once again as a reminder to ask a question. Please press star one.
We have a follow up.
From Zack <unk> from Roth Capital Partners. Your line is open. Please go ahead.
Hey, guys.
Asking all the questions today.
Just kind of moving on here I think the next question as it relates to.
The <unk> opportunity is having.
Having your comment I'll pass on that the size of the market opportunity.
Do you think about perhaps being kind of a late player to the U S market and then maybe you can comment a bit on your survey findings as well.
Perhaps.
And some of the details around that.
Yes, so the U S market.
It's still evolving, but we still have the pandemic, which we believe will continue for next few years. So currently obviously the pediatric thats. The reason we are paid for pediatric use that as a significant unmet medical need and the under <unk> group. There are no vaccines available from 5% to 18 age group, there's only one vaccine option.
Available on the web.
<unk> rates.
The kids, who got two doses from five to 11 range is about 25%.
So to increase the vaccination rates, which are extremely important to prevent hospitalization and death.
And in the pediatric populations majority of the parents are looking for options.
And Thats. The reason there is a great need for pediatric vaccines, which are safe and effective and we have provided a significant amount of data set to agency requesting them to push for the AD Comm meeting.
Second thing is so so the second opportunity is bolster market.
As you know this pandemic will continue.
And <unk>.
People, who got the vaccines eventually they'll be looking for bolsters. Our people were unvaccinated Theyre also looking for options and providing an option such as ours with the broadening immune response and the product which is built on non.
Traditional platform technology, such as polio vaccine.
Can relate to so some of the vaccine hesitancy folks who are still there and vaccinated to date and they can also get an options such as our vaccines. So there is a need for options and providing a vaccine with <unk>.
Solid efficacy and safety and also which is built on a traditional backbone will help we believe significant value because there are people out there that can really provide options to increase the vaccination rates.
And in addition to that.
The U S government is doing a good job.
The vaccine diplomacy.
The purchasing vaccines from U S companies and donating for global use.
Global population vaccinated everywhere up to certain extent this pandemic is not going to be under control.
Therefore, it's extremely important to having multiple vaccines in the toolkit, especially the vaccine our vaccine has expected shelf life of two years at refrigerated temperatures six months at room temperature. So this vaccine will be an ideal vaccine.
Are stockpiling.
And.
That's in diplomacy for global distribution.
Yes.
Thanks, John that's really helpful. In terms of how you're thinking you might have an advantage, but I guess what.
Would you ask that is about how you're thinking about perhaps being able to enroll the study.
Within the U S and EMEA income strategies about how you plan for this.
Ned.
To help with that.
Enrollment of the study and perhaps even some comments around the timing of how long do you think that could take.
Yes.
So that.
The clinical trial.
Information on the poster shortly and clinical trials start out on the.
Correct and trial design and the <unk>.
Really allowed.
Not only are nave population, but.
All of us.
Subjects, who are vaccinated, but does it.
Yes.
Cause I think they have to have a minimum of six months of gap. After the last vaccine doses and they can be enrolled in the study. So we have designed it very gradually.
And the details will be posted to clinical by Soco operates bolsters. The bar. If you have any further questions, we'll be happy to address them.
And again, there's a great need for options in this country and I mean, we get a lot of calls and questions from people across the country and we believe we'll be able to recruit very quickly in this trial.
Thanks, guys and then just quickly for Archie heightened added program. We are very interested in this kind of wanted to get a sense here lately.
Data from that study could become available how much detail do you think you will provide at the time of the next update.
So <unk> hundred 30 <unk>.
Recruiting now.
If you go through the clinical trials to start out details are given.
So this is a phase <unk> trial accommodations.
In each mutation.
We are planning to recruit nine patients each and it is a dose escalation.
And so we will be able to recruit those patients we have identified at multiple sites and the process is ongoing and very very excited about completing recruitment.
This year and continue to provide updates in the second half of this year.
On safety is the main goal for the study in addition to that we'll be looking at.
Efficacy through observational endpoints.
So we expect to provide updates in the second half.
Thank you and then the key thing about this program as it will lead to potential debate, but I use it in multiple inherited retinal diseases in sales just wondering at what point are we able are we going to be able to get a sense of its plot efficacy potential and then can you comment on.
On what you think the market opportunity could be for this program.
Yes, absolutely great question.
That's a good thing about this program.
Not only we are going into phase III. The masters you mutation itself.
In our phase one two clinical trial, we are also looking into Asia.
Asia, which is a modified approach so thats actually is that concept once we show activity in those patients it's working.
Opens up the door for entire RP population potentially you are talking about covering 150 mutation within the RP.
Similar to that the <unk> hundred 90 mutation, which we are envisioning to initiate and those patients do within the next one year and that covers LCA, which is leber congenital amaurosis analytic 27 stations sourdough leads to how at least the three mutations covered which.
You can represent the RP.
LCA covering about 170 presentations 2 million patients globally struggled with these diseases. So that's an enormous.
The opportunity to treat.
A lot of these patients globally.
And significant population within the U S and EU U S has about 100 to 200000 patients hovering between RP in LCA.
Big sized market and tomorrow or it's a it'll be a great help for these patients.
To rescue them, who are in desperate need as I mentioned in my past conference calls.
Many of these patients do become legally blind by the time, they're mid forties. So it's really important that as a sense of urgency needed rescue. These patients. We hope we can be there for them.
Thanks, Doug and congrats on the progress.
Thank you great. Thanks, Ed.
Our next question comes from the line of Brian Chen from Cantor. Your line is open. Please go ahead.
Okay. Thanks, Hey, guys, Hey, guys. Thanks for taking my questions.
Congrats on the progress though.
I have a three part question I'll come back to you and I Hope you can answer them.
Can you comment on the manufacturing and supply and capacity can come back then and just from the capacity ramp up perspective.
Just curious how we should think about the capacity assuming that you all have the pediatric approval in near term.
And lastly, when you think about the broad vaccine market in North America.
Do you expect to look for a partner to speed up.
The production and EBIT, reaching out to.
Additional and vaccinated.
Correct.
And a follow up thanks.
Okay.
So thank you Brian Thank you.
So let me start with the capacity question.
That is.
Is authorized currently as I mentioned on the call we are qualifying.
Julien Hollister the tech transfer is progressing really well by midyear, we'll be completing qualification runs. However, we havent plans our partners in India. As you know this is it.
Inaccurate when vaccine it needs VSO purposes. These days, how actually scaled up to 1 billion doses a year capacity.
And what we have done in the interim we established a packaging sites in the U S and the release testing side. So that we can release the product to our standards through oxygen in the U S.
And those types that are already in operation. So initial supply will immediately come from India from our partners, which gets tested in the U S and packaged in the U S to at least to the public.
While the tech transfer is ongoing and we are planning to build up to $100 million those capacity at <unk>.
Product however, as I mentioned to you before there are three aspects of supply.
Envisioning one the pediatric use the second party booster.
It was in the U S market the third part U S.
Vaccine global diplomacy, so Amit government purchasing doses for distributions abroad. So we believe.
With our partner significant capacity and the capacity we are building in the U S.
<unk> will be able to.
What are the needs are.
And.
Second question you had.
Was it related to reaching.
Some other.
States and also the people who are on my estimated currently the distribution as you know is completely done by the government.
The doses the procurement is 100% done by government and they take care of the distributions per mile and they distribute the states and they are using their own network.
So in future, obviously that may change.
Is that all of this pandemic, our most into endemic and become say annual not boosters and others are predicting and that part time.
Then it gets it prioritization then we have some time to work on those details but.
Now all the vaccines are procured by the government and distribute both government and.
And obviously, we'll be working with some states and local governments the need.
In certain states, but part of this vaccine because it's an option.
Many subjects are looking for we'll be happy to help them.
And then on the partnership.
Do you think that you will need one eventually too.
To kind of wrap up on the outreach or even ramp up that capacity.
As you're thinking about the product profile to the adult population.
Yes, I mean, all of those options are we'll be opportunistic.
Our goal is to maximize.
So play out this vaccine as needed so we'll.
Excluding all of those options.
Okay. Thanks, and then maybe just one on occupy 100.
I'm curious if you can talk about.
Alright remind us about the market size opportunity.
All of the mutations that you are initially targeting.
And.
In regards to the phase one two study that youre running.
Can you talk about what will you need to see before expanding to other mutation type.
Yes.
Typically I mean this is the standard.
Clinical trials with the gene therapy space to look into.
Rare diseases.
Typical.
Our trial follows exactly what others have done the.
The phase two trial the primary object to these safety and do you have to monitor these patients for a year on a.
Three months after checkpoint safety.
And for.
Every mutation you look into the clinical trial multiple observational endpoints.
Then from those observational endpoints once the study is done after one year.
You pick the observational endpoint and make one of them as a primary endpoint into the phase III.
So that means in this case, they're not at the primary endpoint by the time, we go to phase II, maybe different than or adoption.
So as I mentioned before rhodopsin truly callers modify our approach.
So if we show the signaling rhodopsin.
It's working debate supposed to work that opens up the door. So many many mutations.
We also have to be cognizant. These are rare diseases and therefore.
We will methodically.
The clinical trials and fewer mutations and all so to cover part of the RFP and color LCA so that yes.
Just play as I mentioned before our goal is to come.
How will those understand limitations between RP in LTE.
So the market size, you can look into populations.
Yes.
Between <unk> and you will see a 100000 page.
Patients and globally, it's about $2 million.
Covering those understand its limitations currently there is only one.
<unk> product.
RPE 65 mutation that I believe has 11000 patients in the U S.
So there's a significant unmet medical need.
And the significant opportunity and for the gene therapy pricing, Brian I think there are couple of products in the market and you can take a look at it.
And I think other companies are getting there and the pricing based on the similar models.
And one thing I need to see.
What we do.
We need to see in terms of efficacy before you expand into other mutation type event.
I don't want to have a five year Youre planning to also expand into step two in Ibs flowers.
Was curious what kind of bar ship should investors expect in terms of that.
Perhaps a question of improvement.
For your expansion out there.
Other investigated mutation type.
Yes.
On September 19, Brian we wanted to start with <unk>.
And obviously, we do have data on September <unk>, two on the preclinical and other models is the same product remember that so we don't have to repeat any tox studies and so it's a timing issue. So we're going to actually introduce that into the clinic. Since the agency has allowed us to go into an option.
We are confident they'll allow us to go into 792.
Also in discussions.
Actually with the EMA and we do have broad RP in LCA indications from the orphan drug designations in the EU. Therefore.
We're also in touch with the EMA and our goal is at least complete the phase two clinical trials for these three mutations in the U S. While we are in communications with BMA. Then eventually when we go into the clinical clients. After one year, what you're asking is what do you want to see I mean, obviously, we don't believe we will.
Have any issues getting into the clinic with that I mean, obviously, we'll be monitoring the rescue business.
Is progression.
From from.
Gene therapy, the single dose.
How it's protecting people or dose.
And based on the data and the disease progression and rescue based on those endpoints were monitoring we picked the primary endpoint and go into phase III and once we and during this process. Obviously, we believe coding to four obviously, because it's broad and one for LTE.
Fully should allow us for a potentially broad RPM DLC indications.
So obviously, we'll be collecting data in phase one two and carefully moving into cautiously into phase III for all three mutations discipline together.
That's between us and the user will merge the programs with the U S and to you. That's the plan eventually for phase three clinical trials typically the phase <unk> for one year, we hope.
<unk> III will continue to be in the timeframe.
Because you do have to.
Catch the signal and also show.
Based on the primary endpoint illiquid duration during the clinical trial.
Okay, well definitely thus far.
Thank you Chuck.
Okay. Thank.
Thank you Brian Thank you.
And there are no further questions at this time, Ken you May continue.
Yes.
Great. Thank you so much and we want to thank everybody, who took the time to listen in on the call on both <unk> and our modified gene therapy program and we look forward to providing updates in the coming months. Thank you very much and have a great weekend.
Alright.
That does concludes our conference for today. Thank you for participating you may now disconnect have a great day.
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