Q2 2022 Zealand Pharma A/S Earnings Call
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Good day, and thank you for standing by when it come to the Zealand pharma second quarter 2022 financial results conference call and webcast.
At this time all participants are in listen only mode. After the speaker's presentation. There will be a question and answer session to ask a question. During the session you will need to slowly press star One and then one on your telephone.
Or was any I would estimate that message advising that you had is raised.
Please note that today's conference is being recorded I would now like to hand over to your speaker I'm not quite sure Scott. Please go ahead.
Thank you operator, welcome and thank you for joining us today to discuss <unk> second quarter results for 2022, I'm Ana Krasowski, Vice President of Investor Relations and corporate Communications at Zealand with me today are the following members of <unk> management team.
Adam <unk>, President and Chief Executive Officer, Matt, Dallas, Senior Vice President and Chief Financial Officer, and David Kendall Chief Medical Officer.
You can find the related company announcements and supporting information on our website at Zealand pharma Dot Com I would like to point out that we will be making forward looking statements that are subject to risks and uncertainties. These statements are valid only as of today and the company assumes no obligation to update them, except as required by law.
Please refer to recent filings for a more complete picture.
The risks and other factors that I will turn the call over to President and CEO Adam Thanks, Adam.
Thank you Adam and thanks to everyone for joining today, please turn to slide three.
It has been a busy quarter for the company and I'm really happy with the progress we have made on multiple fronts. Following the announcement of our strategy to prioritize investment into R&D.
In light of these changes I am pleased that we competed with Vigo to mankind in may.
For the <unk> rescue pen we are in advanced partner discussions and I hope to provide an update on this front soon.
In the second quarter, we strengthened our balance sheet.
By amending the existing note purchase agreement with Oberland capital and secondly by executing a private placement with certain institutional investors.
This has extended our cash runway beyond important clinical milestones.
As part of the restructuring activities, we continue to focus on improving our operational effectiveness and implementing corporate cost reductions.
Earlier this week, we announced the decision to enter the non liquid ABS program, which has been in place since August 17.
Today, the American depositary shares accounts for less than one 5% of the total share capital and by consolidating our listing to NASDAQ Copenhagen.
We believe we can maintain trading flexibility for global investors, while achieving certain operating efficiencies for the company and reducing costs.
Following dose corporate updates I would like to touch on the clinical pipeline to briefly review some of the progress and upcoming milestones before I turn the call over to David <unk> for additional details and color Keith.
Key priorities as shown on slide four.
As we gave you the pipeline I want to draw your attention to the revised timelines related to basically one five more artificial pancreas system. This is a consequence of focusing our resources as we execute our new strategy and not a reflection of our entre chosen for the program.
In May we announced positive results from the phase III trial of <unk> in infants with container Hyperinsulinism a CAGR.
We are preparing a new drug application or NDA pathetically, Oregon, and following our pre NDA meeting with the FDA. We now anticipate submission in the first quarter of 'twenty three.
At the scientific sessions of the American Diabetes Association in June we presented phase one data for tactical side, our long acting <unk> <unk> dual agonist, showing encouraging weight loss and healthy volunteers.
This data has given us the confidence to move this molecule forward in obesity as also announced in June .
In July we achieved last patient last visit and he's Sps one.
Our phase III trial, with Paclitaxel and short bowel syndrome, and now look forward to seeing the results late in the quarter.
Yeah.
At the upcoming European Association for the study of diabetes annual meeting in September our patent and Johan Lucas and Phase III data for the glucagon tier one receptor dual agonist in patients with type two diabetes and.
And finally, we anticipate initial phase one clinical data from our amylin analogue later in the year.
And with that I will now turn over the call to David Kendall, David was appointed Chief Medical Officer in June and for the past two years has been serving as our senior global medical advisor to the company and before joining us.
She has held senior leadership positions in clinical and academic medicine and in the biopharmaceutical industry. We're extremely excited to have his broad experience in diabetes and metabolic diseases that spans more than 35 years.
David.
Thank you for the kind introduction, Adam I would like to begin by discussing the progress with our does the glucagon program in patients with congenital hyperinsulinism, where CACI and ultra rare pediatric disease in which patients suffer from recurrent and persistent hypoglycemia due to excessive insulin production.
On slide five we have summarized key data.
As you May recall, we previously reported data showing a clinically meaningful reduction in rates of hypoglycemia measured by continuous glucose monitoring in the phase III trial in older children when treated with DRC glucagon added to standard of care shown in the left hand panel.
In May we announced positive topline results from the phase III trial in 12 infants up to 12 months of age with CACI, who required continuous intravenous glucose support to prevent or manage hyperglycemia.
The focus of this trial was to evaluate the ability of desert glucagon treatment to reduce and eventually remove the need for continuous IV glucose infusion.
The trial met its primary endpoints demonstrating the desert glucagon delivered as a continuous subcutaneous infusion pump resulted in a statistically significant and clinically meaningful reduction in the requirement for IV glucose when compared to placebo.
America, <unk> glucagon treatment reduced the mean glucose infusion rates of $4 three milligrams per kilogram per minute compared with $9 five milligrams per kilogram per minute with placebo a treatment difference of five two milligrams per kilogram per minute, which is a 55% reduction in the requirement for glucose.
IV infusion.
It is also worth noting that 11 out of 12 patients participating in the trials subsequently enrolled into the ongoing long term safety extension study.
We look forward to presenting the full trial results of study 103 at the European Society for Paediatric endocrinology or SPE annual meeting in mid September .
We anticipate the data from this phase III trial, along with data from the previous phase III trial in older children as well as the information derived from the safety extension trial will form the basis, an NDA for <unk> glucagon and CACI and we expect to submit in the first quarter of 2023.
We had previously projected a submission in late 2022.
However, as the NDA preparation is now underway the revised timeline reflects the comprehensive analysis for an individual patient outcomes that we believe are essential for our submission, which we further believe will ensure as complete a dataset as possible for our NDA targeting this ultra rare disease.
Turning to slide six our full pipeline is shown here and I will highlight a few of our programs first I would like to share an update on another of our Darcy glucagon projects, namely the by hormonal artificial pancreas program, which as many of you know is being performed in collaboration with beta bionics.
We have recently aligned with our partners on a sequential approach for the phase III pivotal program.
Phase III program now consists of three sub trials designed to support the marketing application for the by hormonal islet Bionic pancreas known as the islet duo and an NDA for the use of desert glucagon and by hormonal artificial pancreas systems for the treatment of type one diabetes.
Our two companies have agreed that the smaller crossover study of 60 patients to assess safety and efficacy of the buy hormonal I'll, let duo and insulin only configuration known as the island will now be completed prior to initiating the two larger randomized controlled phase III trials, which will include 350 adult <unk>.
350 pediatric participants.
Shortly the sequential approach allows for an initial assessment of clinical outcomes from the shorter term comparative trial prior to initiation of the main pivotal trials. The clinical protocols are being updated accordingly, and we expect beta bionics to initiate the small crossover trial in early 2023.
We believe the sequential approach will allow us to optimize phase III execution and use our resources most effectively.
Moving on to <unk>, our long acting <unk>, two analog being investigated for the potential treatment of short bowel syndrome.
The pivotal phase III <unk> study is designed to allow us to demonstrate a significant reduction in the need for parenteral support for people living with Sps.
Once or twice weekly fixed dose injection of <unk> delivered by a ready to use auto injector can provide clear and very important features of differentiation from the currently approved product.
We are excited to report that we have recently achieved last patient last visit in the phase III <unk> trial, and our expectation is to have top line results available by the end of September or early October of this year pending.
Pending review of these data we anticipate that this randomized controlled trial will serve as the basis for our planned NDA for <unk>.
Moving to a discussion of our work in obesity. We believe we have a number of novel and exciting assets in our current portfolio and we are pleased to be advancing this clinical portfolio, including our <unk> <unk> dual agonist, our novel long acting amylin analogue and the dual glucagon.
The <unk> one receptor agonist all assets generated from our peptide platform.
Initial data from the clinical studies of our <unk> <unk> dual agonist Jaffe Glu tide reported at this year's American Diabetes Association scientific sessions demonstrated weight loss of up to four 3% from baseline after only four weeks of treatment in a phase one trial of healthy volunteers.
Our novel long acting Amylin analogue is currently under study in phase one clinical trials and we expect data from the phase one single ascending dose trial by the end of 2022.
This Amazon asset is differentiated by virtue of design characteristics that both allows for once weekly dosing and for formulation and the co formulation with other peptides in the physiologic ph range a feature that should facilitate the potential for development of combination therapies.
Additionally, initial data readouts from the phase III program for the long acting dual glucagon receptor <unk> receptor agonist also known as <unk> 456, 906 being developed with Beringer Ingelheim will be disclosed later this year.
Initial data from the phase III trial in type two diabetes is scheduled for presentation at the European Association for the study of diabetes in September highlighting the primary endpoint of the trial the dose relationship of treatment on hemoglobin <unk> C from baseline to 16 weeks relative to placebo.
Along with RBI colleagues, we also anticipate presentation of the secondary endpoints of the type two diabetes trial assessing the effects of change on body weight at a scientific Congress later in 2022.
In summary, it has been an incredibly active exciting and data rich time for our clinical development programs in the second half of the year looks to maintain the strong momentum across our entire research and development platform.
Now I will turn the call over to our CFO , Matt Dallas to walk us through our half year financial results Matt.
Thanks, David.
In the first half of 2022, we initiated our organizational restructuring taking steps to strengthen our financial future and ensuring the Zealand can continue to discover and develop innovative new peptide therapeutics.
In addition to the 90% workforce reduction implemented in the United States in the second quarter, we amended our loan agreement with Oberland capital and raised $274 $8 million damaged corner in a direct private placement with these events in the consolidation of the exchange listings as mentioned at the beginning of the call by.
The company is well positioned to execute on our strategy.
On slide seven you will see Zealand's income statement for the first six months of 2022 and how it compares to 2021 total.
Total revenue for the first six months was $43 5 million Danish kroner were $6 1 million USD. This was driven by net Siegel our product revenue and partnership revenue from our collaboration with <unk> on the operating result for the period was a loss of $539 2 million Danish kroner were $75 3 million USD.
Sales and marketing costs, mainly related to the commercial construction in the U S to support <unk> R&D costs, primarily related to our late stage clinical programs.
As a result of our announced restructuring all gross margin and operating expenses related to <unk> are accounted for as discontinued operations total discontinued operations for the first half of 2022 megawatts of $97 9 million Danish kroner were $13 7 million USD.
Slide eight illustrates our financial position and ability to support our growing business through continued investments total operating expense for the period was $577 4 million Danish kroner were $80 6 million USD included in the operating expenses for the period are $75 8 million Danish kroner related to our announced restructuring.
And cash on hand at the end of June 2022 was $864 4 million Danish kroner.
20 <unk>.
7 million USD.
Turning to our financial guidance on slide nine.
The company anticipates that net product revenue from sales of <unk> <unk> is expected to be $11 5 million gamescom plus or minus 10%.
This is a reduction of $7 5 million Danish kroner from our updated guidance issued on May 12, with the completion of the asset purchase agreement for <unk> and that kind of with Mannkind Corporation. The company will no longer provide guidance on net product revenue associated with sales from that program.
Zealand pharma expects revenue from existing license agreements. However, since such revenue is uncertain in terms of size and timing, we do not intend to provide guidance on such revenue.
Net operating expenses in 2022 are expected to be 1 billion Danish kroner in plus or minus 10%. This is unchanged from our prior guidance and the decrease of $200 million James Garner from the original guidance issued on March 10th.
With that I will now turn the call back to al.
Thank you Matt.
As previously announced he will be leaving <unk> by the end of August .
And this will be his last quarterly call I would now I would like to thank Matt for his leadership and many contributions over the last few years and I wish him all the best with his next chapter.
In light of Matts departure, we have been conducting a search for a new CFO for the company.
And we expect to be able to make an announcement soon.
Turning to slide 10.
The second quarter has delivered on several fronts and we believe <unk> is now well positioned to leverage the value of our pipeline.
We have some exciting months ahead of us with significant number of important milestones, which will further clarify the potential of our many new product opportunities.
Thank you all I will now turn it over to the operator for questions.
Thank you Sir.
To ask a question you will need to slowly price, Taiwan, and then one on your telephone and wait for your name to be announced once again is still one and then one on your telephone and wait for your name to be announced please standby, while we compile the Q&A roster. This will take a few moments.
We are going to proceed with the first question.
Our first question comes from the line of Joseph <unk> from Needham <unk> Company. Please ask your question. Your line is open.
Hi, Thanks for taking our questions.
Into the SBS lead out here can you provide your thoughts.
Based on feedback from physicians.
Which efficacy endpoint is.
Most important for potential.
Widespread adoption or uptake in the SBS market for example from a registrational perspective.
Obviously your primary endpoint is at.
Absolute change in PFS.
<unk> was approved on.
In part on a different endpoint, the responder analysis greater than 20% reduction.
But are there other key endpoints such as.
Number of patients completely waned off PFS or.
Change in other metrics that you would consider important from a potential commercial perspective. Thank you.
This is David Campbell, Thanks for the question.
<unk> very nicely summarized both what was part of the previous <unk>.
Regulatory approval for.
Nucleotide.
And given the construct of our trials obviously the statistical power for registration is tied to a reduction in the volume of parental support.
And secondarily looking at a similar proportion.
A reduction in that parental support but I think you also make a very important distinction which is.
The potential to reduce the number of days on parental support discontinuing parental support either on a given day or a series of days will be critically important obviously powering a study for regulatory review based on the ladder.
Has its challenges given that this is a rare disease and having adequate numbers of subjects to demonstrate that with clarity or certainty.
Could be challenging however, we will be collecting adjust that in our clinical program to.
To assess.
There are meaningful reductions in the days off of parental support so I think all three go well beyond just achieved.
Achieving a regulatory endpoint.
And our critically important both to the burden of SBS and ultimately to the significant burden of days on parental support.
Great. Thank you for taking our question.
Okay.
We're going to proceed with the next question.
The next question comes from the line of Lucy Codrington from Jefferies. Please ask your question. Your line is open.
Hi, Thanks for taking my questions on <unk> and just.
Along with yesterday's that day.
And the expectation for data.
Just in terms of setting expectations.
Should we be looking at the kind of one to 10.
Reductions in rental.
Nutrition volume in the downturn in the phase III.
30% placebo adjusted response rate.
Since football is the efficacy.
And then.
Related to that can you remind us of any justification by Wyndham lastly in your trial.
Does that differ to that used in the <unk> phase III and could that have any influence from the lithium.
The data set together with the caveat that Chuck capacity to cope.
Are there any other differences between the phase III that we should be aware of.
Thank you gentlemen, thank you very good if I can test my short term memory and recall those I think your first question too.
Proportional response, if you will and reduction of parental support.
We know Thats what <unk>.
As a <unk> agonist just like nucleotide.
So while these are not comparative studies, obviously this is placebo controlled.
We would estimate that at <unk>.
<unk> qualitatively reductions that have been seen with the other <unk> <unk>.
<unk> agonist would be those that we would expect.
But obviously to.
Go further and try to predict at this point, what those data may show would be both premature and speculative only.
I think.
That is.
A reasonable starting point certainly in.
I think I wrote it down but I've already lost the second half of that question.
And just whether there was any justification.
<unk>.
So we do have so called kicker colon and continuity subjects as well as stoma patients within the trial, but there is no a priori at least primary endpoint for assessing differences, but obviously this will be a part of the secondary analyses that we will undertake.
Obviously understanding that those two populations can behave differently, particularly when it comes to completely withdrawing parental support so yes that will be part of our analysis does not obviously part of the primary endpoint.
And then just.
Just to be clear on the differences between the you would expect.
With quantum.
Continuity to respond less is that right.
Yes, correct.
Okay.
Great and then just my last question does relate to Daphne side.
I think the T trial at least the ladies and the question is if it's going to be an investigator sponsored study is that and does that just reflect with those clients.
<unk> been conducting the charge itself.
I think it is not solely a resource utilization question, obviously, there will be more than just efficacy endpoints and opportunity to explore mechanistic components of how the compound acts.
Which.
Obviously done most effectively.
Well established academic center, which does trials looking at complex.
Complex mechanistic responses.
Two of the acreage on hormones, so I think beyond.
Some efficiencies of being able to initiate this.
Earlier for a relatively more efficient cost.
In the setting of an investigator led trial.
It will also allow for that.
Detailed look at central mechanisms, which may be at play.
For this very novel agent.
Okay.
Well thank you thank.
Thank you.
We're going to proceed with the next question. Please standby.
We have the next question is coming from the line of Mike <unk> from Nordea. Please ask your question.
Thanks, a lot it's Michael <unk> from Nordea.
Three questions.
First of all to the.
45 compounds the clip.
<unk>.
Co agonist, so I can see that the strike is already entitled in the in the Essex books. So maybe just two two.
Sort of gauge your confidence in the safety because we have had a lot of discussions around through hook on safety, we have seen a publication by novo with their glucagon.
Compound <unk>, one glucagon, which which didn't sort of.
Look two promising in terms of safety. So just gauging your confidence on the safety side going into the year you can't.
Comment on the specific data.
And then secondly on the unsecured book, maybe Adam you could give a bit of.
Extra color on the potential timing of a of a license deal.
For this asset and then lastly also.
With respect to <unk>.
How should we think about timing with regards to also a license deal on this given that you are sort of progressing if data is positive towards submitting an NDA.
A potential path I would like to be.
Active on that side as well or how do you think about timing for ethically Pat shoot data would be positive.
This is David I'll start with 456 900, <unk> question and the safety profile, obviously phase two is really the first more comprehensive look at.
Efficacy and safety and I think as you suggested having the posted abstract.
For the compound.
As both exciting for us and we look forward to seeing the full details of the glycemic outcomes at Eas.
I think it would be premature to further speculate.
On behalf of RBI partners on the comprehensive safety.
But obviously, we fully expect the Tolerability and safety will be detailed in that presentation.
But given that we now have completed that phase two in <unk>.
<unk> population.
Suggests that at least completion of the trials supports utility to go beyond that I think I'd be getting ahead of the formal presentation.
Speculating on the safety outcomes.
Yes.
We also have just a follow up on David's Nokia, which I completely agree I think at the American Diabetes Association meeting in June did show some more details on the molecule, including the ratio of <unk>, one and so on that.
I think you should be capital to compare across these molecules, even though they are named look on a global until the one that could be different ratios and very quiet.
Visual observations for each molecule so.
I would also asking to draw the attention to the presentation that I made at the American Diabetes Association meeting then.
<unk>.
As I said, we are in advanced discussions.
And I've said, all the time that it is our ambition.
To compete a deal before we did this quarter and this is still the ambition for the company and I think it's premature to comment more on this until we can announce something hopefully.
The last one <unk>.
Now really the key focus for us too.
To get to the key results and then ill.
<unk> with FCA and on the patent front.
Our key focus right now is two to two <unk>.
Complete our discussions.
On <unk> and then we also have <unk>.
We're coming up with so.
It's not that we are in a hurry, we think we have a path.
And a good place and but as I've also shattered product also had quite a significant inbound interest in the program. So we will kind of.
Take it from there, but we will not advanced these discussions until we have seen results for sure.
Okay.
Thanks, a lot. Thank you.
Okay.
We are going to proceed with the next question.
The next question comes from the line of Thomas <unk>.
From.
Sounds good bank. Please ask your question your line is open.
Yes, great. Thank you very much a couple of questions from my side. So so can you maybe just give us a little bit of color on on the USD listing. So in terms of annual cost savings, so including fees and insurance and Andy can stuff.
So that was the first question. So just then just a follow up on <unk>.
Can you maybe just remind us on the commercial commitments you have.
Going into August .
I think that makes things a little bit more difficult for you and also in addition to the recent capital infusion. So I'm just wondering whether you are maybe looking.
More into sort of an out license with the with royalties.
Compared to sort of a onetime upfront payments from from just selling the asset and then my last question just on NPI 45.
Just wondering in regards to poultry are all awaiting the phase III.
I mean bearing a private company. They could also make a decision prior to those phase II data and then going to announce phase III. So I'm just wondering whether you have any information or where you may be you could potentially see bearing I'll.
Take that decision prior to the phase II data if that's possible. Thank you.
Okay, So maybe I'll address that.
And then so I know what the ADR question to Matt and the potential cost savings, but then if we take.
And of course.
You can see.
We expect <unk>.
Lymphoma is when they take that decision and we will probably also inform the market if that decision will be taken on the communication of phase III and we cannot comment further on when they would take this decision right now if they would do it before.
We have also seen the phase two data from their PCT study, then I remind you that the type two diabetes study that has been presented at <unk> and also later this year, so, but we do expect them to see the full data from the <unk>.
PCT study as well so this is really off of.
To decide and we will of course inform accordingly.
<unk>.
I really can only you can they confirm that beyond advanced discussions we are keeping the product on the market. We are supporting the product from all the regulatory and medical supply aspects.
Very little sales support as you can also see from the numbers now.
So it's completely in line with the restructuring.
Restructuring that we announced.
The proposal to why we have a key focus on competing at potential agreement before we did the quarter. So.
And I can honestly.
I will not comment more on the deal potential deal structures.
Our focus for us at this time.
Matt maybe.
Over to you on the Adi potential cost savings.
Right, Yes, we have not.
Publicly stated what our exact expectations are on a per dollar basis, but I can tell you that.
The cost of maintaining the U S listing requires significant external legal and audit requirements.
Requirements due to the regulatory reasons as well as.
Significant internal.
<unk> costs and efforts in finance legal risk management.
As this delisting.
Takes place from occurs we will see significant.
Costs reduced from those areas as well as again internal kind of focus as well.
Okay got it. Thank you very much thank you.
We're going to proceed with the next question.
The next question comes from the line of Lucy Codrington from Jefferies. Please ask your question. Your line is open.
Yes.
Thanks.
And let me see your line is open you may ask your question.
So my apologies.
Just if I may is it possible to get.
Updated cash runway guidance now following.
<unk>.
Yes.
Kevin.
The capital raise.
And then.
In terms of potential near term milestones.
Is it in.
On guidance is there anything that we should be aware of that could be a possible near term marketing. Thank you.
Matt will you start on this one.
So right now the current cash runway.
Based on just as the company stands at this very moment.
Takes us into Q2 2023. This does not include.
Potential <unk> partnerships does not include any future milestones such as from our partnerships with <unk> or any.
Additional partnership cost savings from any of the other additional programs with obesity in SBS.
Also includes the full burden.
Maintaining the dual listings to dual listing has not been yet.
Completed so as we move into <unk>.
The next period, and we updated guidance on that side.
All of those costs will be filtered through.
Reflected in future announcements.
Great. Thank you.
Thanks.
We have no further questions at this time I will now hand back the call to Mr. Adam Steinberg CEO for closing remarks. Please go ahead.
Okay with that we would like to thank you all for attending and for your questions.
Very much forward to connecting on future announcements and updates have a good day.
Sure.
This concludes today's conference call. Thank you for participating you may now disconnect your lines.
The country will begin shortly to raise your hand during Q&A you can dial one one.
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