Q3 2023 Fulcrum Therapeutics Inc Earnings Call
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Okay.
Good morning, and walk them Triple Crown Therapeutics third quarter, 2023 financial results and business update conference call.
Currently all participants are in a listen only mode.
This call is being webcast live well the investor sections of four clubs website at Www Dot for Chrome T X dot com and is being recorded.
Please be reminded that remarks made during this call may contain forward looking statements within the meaning of the private Securities Litigation Reform Act of 1995.
These may include statements about the company's future expectations and plans clinical development timelines and financial.
Jackson.
While these forward looking statements represent for crumbs views as of two days this should not be relied upon as representing the company's views in the future.
For Prime May update these statements in the future, but it's not taking on any obligation to do so.
Please refer to pool problems. Most recent filings with the Securities and Exchange Commission for a discussion of certain risks and uncertainties associated with the company's business.
Leading the call today will be Alex Sapir, CEO and president of four P. M.
John and Alex on the call are Alan Musso, Chief Financial Officer, and Dr. Ian Frazer interim Chief Medical Officer.
After providing updates on all key programs that will be a brief Q&A and which Alex Allen and will be available to answer your questions.
With that it's my pleasure to turn the call over to Alex Sir you may begin.
Great. Thanks to Wanda and thanks to all of you for joining US today, we are pleased with the progress that we've made in the third quarter of 2023.
Our two clinical assets.
Sure Derrick.
In addition, we remain well capitalized with a cash position of 257 million as of September 30th and have extended our cash runway into 2026.
Dziedzic review and budget process only in our essential priorities.
So what I'd like to do this morning is to provide an update on our Q2 key programs. Most map of mine for Fattier Scapulohumeral muscular dystrophy breakfast H D and pro series here previously referred to as F. T X $6 58 for sickle cell disease, after which I'll turn it over to Alan for some financial highlights.
So let's start with our most advanced program was mathematics, and just as a quick reminder, most mathematic selective P. <unk> P 38 Alpha beta map kinase inhibitor is currently in phase III development for the treatment of FX H D for which there are currently no approved treatment options.
<unk> Fsh D as a form of muscular dystrophy with an estimated patient population of 30000 in the U S alone.
The disease is characterized by a slow and progressive loss of muscle function over many years.
<unk> and significant impairment of upper extremity function and mobility as a result, many patients are unable to perform many of life's dailies activities that we all take for granted like reaching for a cup of coffee in the kitchen cabinet brushing your teeth, BD oneself and even practicing good hygiene. These critical factors that are in.
Sites on the genetic underpinnings of FX HD drove us to identify and develop a safe and effective treatment option with the potential to slow disease progression for these patients.
In September this year, we completed enrollment and reach our global Phase III trial for Louis Mathematic, which we initiated in June of 2022, we believe that the rapid pace of enrolment of the 260 patients into the trial is a real testament to the high unmet need of this rare disease. We are on track to report top.
Line in the fourth quarter of 2024, which will bring us one step closer to delivering the first ever FDA approved therapy for Fsh date.
Now let me just give a quick reminder to everybody about reach reaches a 48 week trial intended to be registration, enabling both in the U S and in ex U S geographies.
Mary endpoint for this study is the change from baseline in the relative surface area or <unk> R. R. S. H score, which is a quantitative assessment of reachable workspace or our Ws. This is a measure of upper extremity range of motion and function that specifically evaluates shoulder and arm mobility.
Using three D motion sensor sensor technology preserving this upper extremity function is critical for patients to maintain their independence and their ability to perform some of these activities of daily living that I spoke about earlier as part of this study will also be looking at other key secondary endpoints like muscle fat.
Infiltration or MSI, which is an important marker of disease pathology measured by whole body MRI as well as reported quality of life measures.
And health care utilization questionnaires that will help inform our thinking on our payer strategy as we begin preparing for a commercial launch here in the U S. We are pleased to have reached there is no pun intended there. This critical milestone and we look forward to sharing with everyone topline results in the fourth quarter of next year.
So let me now move on to <unk>, our oral fetal hemoglobin inducer or hbf for sure for the potential treatment of patients with sickle cell disease in August 2023, the FDA lifted the clinical hold on our investigational new drug application for <unk>.
Our dear for the potential treatment of sickle cell disease, our interactions with the FDA, we're productive and collaborative throughout the hold and we're pleased to have aligned on a revised inclusion exclusion criteria that targets a more severe patient population for this phase <unk> study.
I think it's also important to note that there were no changes in the protocol defined dose escalation scheme or the three month treatment duration.
We are working hard to resume enrollment in the phase <unk> study at the 12 milligram dose followed by the 20 milligram dose of <unk>. Each of these dose cohorts are scheduled to enroll 10 patients. We are reactivating current sites as well as identifying new sites in the U S and ex U S that are excited to participate.
As many of you know activating new sites takes time, given the contracting and IRB approval process.
I think once we have a few months of enrollment under our belt, we'll be in a far better positioned to estimate when we would expect to have results of the 12, and a 20 milligram to share with everyone.
I just want to take a minute and talk about why we're so excited about <unk> given the fact that this is only in a phase one b.
Phase <unk> study.
So data that we obtained prior to the clinical hold demonstrating that <unk> increased total fetal hemoglobin of a magnitude that could translate into a meaningful improvement in disease severity.
Typically after only 42 days of treatment, we observed up to a 10 percentage point increase.
Don't hemoglobin from baseline or total fetal hemoglobin of approximately 25%, we believe that as an oral hbf inducer. We believe that <unk> has the potential to provide a differentiated therapeutic option for patients living with sickle cell disease.
Addressing the significant unmet need in sickle cell remains a key priority for us and we look forward to providing further updates on our progress.
So with that clinical update I'll now turn it over to Allen, our Chief Financial Officer, who will provide an update on our financials. Alan has been a great addition to the team since joining in August and he will be invaluable as we move into the next phase of growth and continued to advance our mission of delivering these transformative therapies, so alan over to you.
Alright, Thank you Alex.
Well, let me start with our cash position. We ended September 32023, with cash cash equivalence and marketable securities of $257 1 million.
And during the third quarter, our net cash burn was $21 1 million.
We continue to operate from a strong financial position and based on our recent operating results and current projections. We now expect our cash runway to extend into 2026.
An update from our prior guidance of mid 2025.
In the third quarter of 2023, our collaboration revenue was <unk> eight.
8 million that compares to $1 2 million for the third quarter of 2022.
Our research and development expenses were $18 2 million for the third quarter of 2023 compared to $15 4 million for the third quarter of 2022.
The increase of $2 8 million was primarily due to increased costs associated with the advancement of our phase III reach trial.
Including the completion of enrollment during September 2023.
Our general and administrative expenses were $10 million for the third quarter of 2023.
As compared to $9 7 million for the third quarter of 2022.
The increase of <unk> 3 million was primarily due to increased facilities professional services and software costs.
Our net loss of 24 million for the third quarter of 2023 and that compares to $23 7 million for the third quarter of 2022.
And with that turn it back over to Alex Great. Thanks, Alan and again, great to have you on the team so to Wanda, Let's let's go ahead and open it up for questions.
Ladies and.
Gentlemen to ask a question. Please press star one on your telephone.
And wait to hear your name announced two.
To withdraw your question. Please press star one again.
Please stand by while we compile the Q&A roster.
Okay.
Our first question comes from the line of Corinne Jenkins with Goldman Sachs. Your line is open.
Good morning. This is Craig on for Kirk So I had one specifically related to the series here.
I guess with that Phase <unk> study what are you guys hope to see in order to consider moving forward the program.
And based on that what do you think you need to show from a risk benefit point of view in order to get the FDA to maybe reconsider the current patient population youre evaluating the agent 10, maybe a broader one. Thank you yeah. That's great. Thanks for the question Craig and let me.
Let me turn that over to Ian Frazier, Our Chief Medical Officer, Ian Ian has really been instrumental in driving those conversations with the FDA. So I think he's probably best equipped to answer that question, yes. Thanks, Alex.
Thanks for the question is that Alex mentioned earlier at the 12 milligram dose that we've studied to date, which was only a partial cohort essentially only three patients and the longest duration of 42 days, which is six weeks halfway to the treatment period, we were seeing.
<unk> of around 10 percentage points in the fetal hemoglobin, obviously, it depends where where youll baseline hbf starts out as to where you end up and there was at least one patient there started out at about 15 relatively high and reached 25, which we believe and I think backed by the electric.
Sure.
You add to the high 20% range of total hbf.
You significantly impact the symptoms of sickle cell disease. So that's the range that I think will be most convincing to reach and I think what we're trying to demonstrate.
This is with the 12 milligram dose as we extend the duration of dosing.
To the full three months.
How much higher do we get the fetal hemoglobin to rise and across the entire cohort at different baseline fetal hemoglobin.
Hi to each of those individuals reach so so thats our intent.
The target towards which we are shooting.
And as we've articulated previously based on our earlier healthy volunteer data.
We believe that there is even further incremental efficacy to be gained as we go up from 12 milligrams to the next dose around 20 milligrams.
And we fully expected that.
Even the 12 milligram dose.
That's the direction analogy, we expect that's the region of <unk>.
Total hbf that we think will be significantly transformative.
And that's what the data will be looking for as we as we start to dosing in this cohort and then Craig. This is Alex let me just sort of answers. Your question about what do you feel like we need to show to the FDA.
To expand the patient population, but beyond where we are today I think that obviously the FDA looks at everything from a from a risk benefit.
Perspective, and right now we've shown some benefit, albeit in a very small number of patients. So if we're able to achieve what.
<unk> spoke about we will take that information back to the FDA and have what we believe is a very sort of thoughtful.
Helpful discussion armed with much more data to show how this drug can benefit.
<unk> and from there we believe that over the long run we will be able to expand that patient population I think what's important to remember is that.
Been a lot of talk recently of the past couple of weeks with.
The vertex CRISPR cell and gene therapy compound as well as bluebirds and I think that if you look at it.
Levels of fetal hemoglobin that theyre able to get up to in the thirties.
We do believe that with based on what we've been able to show prior to the whole we believe that with three months of dosing with the 12 milligram at potentially three months of dosing with a with a 20 milligram, we may be able to get up to similar levels and I think thats very very exciting for for the sickle cell community and for the patient specifically.
Got it thank you very much.
Thank you.
Please standby for our next question.
Our next question comes from the line of Daigle Hot with Stifel. Your line is open.
Hi, This is Ben <unk> on for Dave. Thanks for taking our question just a couple of <unk>.
Challenging hasnt been to refine refine some of the prior trial sites okay.
You can participate in the trial at this point can you share some color on that and what are some of the questions that they are having about the.
The clinical hold and how they can feel more comfortable about drug safety and then a follow up to that is we know that youre not exactly sure about when youre going to have data out to <unk>, but.
Is it more likely to be mid year or year end or somewhere in between.
It's not at a conference presentation for the company. Thank you Yeah. That's great. Thanks for that Darren Let me, let me start and then.
Ian Please feel free to jump in if I, if I Miss anything so yes. So just as a quick reminder, we had seven sites in the phase <unk> study prior to the initiation of the hold and as just as a reminder, that was an all commerce study. So our plan specific and they were all U S sites are planned specifically in the U.
The us is to double the number of is to double the number of sites specifically in the U S as well as to look outside of the U S. As well and we feel that we need to go to a greater number of sites simply because we have a more narrowly defined.
Inclusion exclusion criteria. So it will be a more difficult trial to enroll than we <unk>.
In the past.
What I.
I think what we've been hearing from physicians and I'd like to comment on this as well, but I think what we've been hearing from physicians is.
The benefits that this drug as an oral hbf inducer can provide to patients right. We've been able to show up until now that with six weeks of dosing at a 12 milligram dose we can get patients to total fetal hemoglobin levels of 25% and I think that's I think that's really exciting for the.
I think that's really exciting for the sites and the physicians that are going to participate in this study and I think it's also very exciting for the for that.
For the patients as well I think in terms of when we think we'll be able to show that I think right now our focus has really been on engaging with the centers. Once we have those centers set up we've got a couple of IRB that are already approved that we have.
One site that is ready to start receiving drug.
And we're also doing a lot with the community sickle cell community in around those types of really sort of educate the community about this this very very interesting study that the center is now participating in so that's really been our focus I think at this point.
Zero.
If I was to give you sort of any indication the only thing I would now with great certainty is that that and that indication of that guidance would be incorrect. So I think give us give us a couple of months, let us let us get a couple of months of patient enrollment under our belt as I've said in the past and I think at that point, we'll be in a much better position to provide.
<unk> more specific guidance that I feel I feel more comfortable so anything else you think around the centers Ian.
Thanks, if I can provide a little bit of color around the types of sites themselves.
And as Alex alluded to earlier.
As an all comer study and so we were at a number of sites that started out essentially as pediatric sites.
The sickle cell disease care is administered.
A lot of the pediatric sites hold onto their older patients as they go into adulthood, because they don't have great partners to transfer those patients too and so we had a number of those sites within the study originally.
Those are obviously somewhat younger patients overall.
Less treatment experienced and less severe impact of disease, just given the duration that we've experienced.
And what we're finding as we go out is that a number of those sites feel that they don't have quite the level of severity or or previous treatment experience.
That we might need for the protocol.
So those are sites that are not continuing but some of them clearly still do have those patients.
So thats been one experience and then we've also broadened our net and now looking at a number of sites that treat exclusively adults that obviously do have many of these most severely impacted patients and so we're bringing them into the fold as well. So we're casting a wide net we've noticed those subtleties of the.
Patient populations at the different sites and.
And we're meeting with lots of investigators.
Excellent. Thank you so much.
Thank you.
Thank you please standby for our next question.
Okay.
Our next question comes from the line of Joseph Schwartz with SBB Leerink. Your line is open.
Hi, It's Joe Schwartz from Leerink partners I was wondering if you could talk some more about how the new inclusion criteria and negotiated with the FDA could influence the profile of disease severity.
<unk> will be reflected in the future cohorts for the phase one b purpose here or there and do you think that <unk> will still be able to generate an increase in fetal hemoglobin.
Which is sufficient for generating a clinical benefit in patients with more severe disease I guess I'm wondering if you think the patients and future cohorts, we'll have as much of an opportunity to reach the 20% range referenced earlier, if they're starting out at lower baseline levels.
To those who were treated previously yes, great question, Joe I think to answer that let me turn that one over to Ian.
Absolutely and it's one that we've.
We've given a lot of thought to and I think it'll be interesting to see the data as it rolls out I think I'd make a couple of comments about it one is in the 16 patients that we've treated thus far in the <unk> study it was a pretty high rate of baseline fetal hemoglobin.
And while we don't have full three months data in all of them. The initial trajectory of increased in hbf, it's pretty consistent across all of those so it didn't seem as though it was higher.
Steeper rate.
At the higher baseline hbf.
The lower ones appear to be responding just as well. So that's the first point. The second point is I think the mechanism of action being distinct from that of HQ.
It has some advantages in this respect obviously will need to demonstrate that as we move into the more severely impacted patients, but it's not an operating through a stress erythropoiesis type response, which HQ is.
Some discussion about whether that mechanism might be susceptible to depletion of stem cells.
<unk> in the marrow whenever description you wanted to append to it so I think that the differentiated mechanism of action acting through operations and gene transcription.
Are likely to be successful in that more severely impacted patient population.
But we will get the patients in and we will have to demonstrate that in the clinic and thats our expectation.
Interesting. Thank you and then could you just walk us through the calculus, you employed to develop the estimate that your inclusion criteria.
<unk> per share Dear covers seven five to 10000 sickle cell patients in the United States and I'm. Just wondering how confident you are in that estimate as you engage with the sites now and what do you expect the screen failure rate for patients to be going forward.
Yes, maybe.
As it relates to the screen failure rate.
I'll ask Ian to answer that but let me give a bit of color Joe in terms of how we got to that number I think what's important to remember and looking at the.
And looking at the inclusion and exclusion criteria. These are people that have either tried and failed on some of these advanced therapies or for whatever reason don't have access to the to the to the advanced therapies <unk> and <unk> because of the simple fact that they don't have insurance and their co pays or are too.
Hi, So let me let me give you some high level numbers, we know that.
From 2019, when both Fox and Chris launched through 2022.
Both of those.
<unk> general each generated about 10000 prescriptions.
We know that about 25% of those prescriptions never converted to a patient start and our assumption. There is that those patients simply didn't have proper insurance cover it didn't have access.
It didn't have access to the drug due to payer related issues. What we also know is that during the first year you saw about a 30% discontinuation rate.
With box, we don't actually have specific numbers for <unk>.
Discontinuation rates in the first year, but you could always just you could assume that it's probably similar to box, maybe a little bit higher because it does require sort of infusions at an infusion center. So instead of doing all of that math gets you to around sort of 75% to 10000 patients where that number.
May be over estimated is the fact that not all of those patients meet the patient severity criteria, but where that number may be an underestimate is the fact that it doesn't include any prescriptions in 2023, we only have prescriptions through 2022, so sort of taking <unk>.
All of those numbers into consideration that's how we sort of arrived at that at the 75 to 10000 pace.
Patients in the U S that meet that inclusion exclusion criteria, which represents about seven 5% 10% of the.
A total of 100000 patient population.
Or do you want to address your second question, yes. So.
This is Ian.
We havent projected as screen fail rate at this point I can tell you that for the initial phase of the study.
Where we recruited 16 patients that screen fail rate was a little over 50%.
So it was a relatively high screen fail rate at that point, and we're sort of carrying that forward at the moment, even though patient population is likely to be more severe.
Have more experience with the sites and with the education of the sites around the protocol and so expect to be able to help with that with patient selection in that fashion.
Yeah.
That's very helpful. Thanks early insight, yes, thanks, Joe.
Please standby for our next question.
Okay.
Our next question comes from the line of Edward Tim Hoff with Piper Sandler Your line is open.
Great. Thank you good morning, everyone.
Okay.
No one ever asked a question around poor little snap a lot I guess I'll be the one.
Yes.
With all of the data coming in the back half of next year, what are some of the commercial prep that you're doing and as you kind of project out here, what's the calculus between keeping a of launching it yourself partnering it maybe partnering it overseas.
Just update us on sort of where your head is on that yes, absolutely. Thanks. Thanks. So much for the question to Ed and I. Appreciate you asking that question unless Matt Vermont. Thank you. So yes. So just as a quick reminder, we would have we plan to have topline results in the fourth quarter. We would then file the NDA sometime in early 2025 for an approval.
Sometime in 2026, we've been very clear that we believe that we can launch this drug quite successfully in the U S with a fairly sort of modest commercial infrastructure, while at the same time looking for partners ex U S.
And we will begin the process of sort of standing up that commercial organization.
The end of this year beginning of next year, starting with our first kind of key hire which would be that.
Would you be that chief commercial officer, and I think one of the reasons that we're so excited about our ability to be able to do this ourselves as a fairly sort of concentrated market. It's a fairly small number of neuromuscular specialists that treat these patients with fsh day.
We're very very well organized from a patient advocacy standpoint, and we have an excellent relationship with the with the Fsh D Society and the fact that there are currently no treatment options and the drug that is probably the closest behind US is probably two to three years roche's product that's myostatin.
Inhibitor.
Two three years behind US we believe that we really do have an opportunity to be successful with this launch in the U S doing it ourselves and then the ability to help a tremendous number of patients in the U S as well as working collaboratively with our partner actually use to help patients.
Around the world.
That's super helpful and I do think it'll garner more attention as we get into new year. So thanks for the update yes. Thanks, Ken.
Ladies sandbox our next question.
Our next question comes from the line of Matthew <unk> with Oppenheimer <unk> Company. Your line is open.
Hey, guys. Thanks for the question.
I will also jump on the FX HD bandwagon here.
I wanted to ask maybe about some different scenarios for each three and specifically if you thought path forward.
If the study doesn't hit or maybe narrowly missed reachable workspace.
Endpoint like do you think the biomarker endpoint might be sufficient.
I guess, taking a page out of <unk> playbook in what we've seen now over the last couple weeks, what kind of what are your thoughts there. Thanks, Yeah, Great question, Matt Matt. Thanks for that so let me, let me turn that one over to Ian.
Yeah. Thanks, Matt So just to be clear in terms of <unk>.
Biomarkers in reach we are not evaluating.
Deducts for transcriptome, which was evaluated in the phase II study is that's not really a feasible clinical trial measured to make what we do have however are a number of secondary endpoints.
Are different than the reachable workspace endpoints and those include the MRI endpoints, which I guess could put could be considered a biomarker, which evaluates the accumulation of fat and.
In muscle tissue that still has.
What looks like normal contractile muscle interspersed with faster. So that we also showed in the phase II study.
As for the reachable workspace that you've got a stabilization of that fat accumulation.
Relative to the placebo, who showed an increase so we think that thats clearly an important secondary endpoints. We also have an evaluation of dynamometry, so conventional muscle strength testing.
Which we're evaluating we have some patient.
Patient reported outcomes that reflect on both.
Patient global impression of change, but also some specific questions related to two fsh D itself and.
So there are a number of those secondary is that I think will be important.
To consider.
Irrespective of what happens to the primary endpoint, but if as you articulate the primary Mrs. Narrow Lee I think having all of those secondaries trending in.
In a favorable direction towards loss not promote over placebo will be extraordinarily helpful and.
And persuasive in that context.
Yeah.
Thanks for the question, Yes, Matthew this is Alex the only other thing I would I would add to what Ian said is going back to something I said earlier regarding <unk> and how the FDA looks at everything from a risk benefit.
Perspective, I think what's also important to note is that when we file our NDA with the FDA, we will have over 3600 patients in our patient safety database and this has been shown to be a very very safe drug and so I think that that that that is.
That is a really important piece of information that the FDA will look at as it considers the safety and efficacy data in totality and decides whether to approve this drug or not for patients for which they have nine.
Yeah makes sense. Thanks, yeah. Thanks, Matt.
Please standby for our next question.
We have a follow up from the line of Dae Gon Ha with Stifel. Your line is open.
Hi, just one more question from us.
For FSA, Steve can you remind us of the powering for each of the assumptions that went into it for the reachable workspace.
Given that it's a mobility test how should we think about it in the context of the recent embark trial failure in.
In what way through front of the powering assumptions vary.
Yes, Great question, let me turn that over let me turn that one over to Ian Yes. So reach was powered based on the observed data from from redox flow from the phase two study in.
And you May recall that was an 88 zero patient study 40 in each arm and essentially what we took was the change from from baselines of the treatment effect cost Matt for months.
Minus placebo on the reachable workspace and also assess the variability in the measurement in that particular cohort and then apply that to the power calculations for the reach study. The reach study was originally powered on.
On a total enrollment of 230 patients with an expectation that 210 of them would be sshd type one and 20 of them would be type two and thats a reflection of the relative epidemiology of type one versus type two type one is overwhelmingly the most prevalent 95%.
So after that the Readouts for study enrolled only type ones and so even though we're enrolling some type twos in the reach study.
We powered the study on only the type one so the study was powered on an expectation of 210 type one patients in the reach study and that gave us the power of of 93 or 94% using the magnitude of change and the standard deviation from <unk>.
As it turns out.
When we cut off.
Screening for the reach study based on what we saw the screen fail rate was going to be in order to reach those 230 patients the screen fail rate dropped down and we ended up enrolling a number of more patients and so at the end of the day. The total enrollment was 260 instead of 230.
And of that $2 60, there were 18 Sshd type twos. So we now have 242.
<unk>, one <unk> $2 42 versus the original powering around 210.
So that bumped the power up into.
Over 95% using the same assumptions from redox floor. So that was an inadvertent over enrollment that that wasn't our intention but.
It was a reflection of the enthusiasm at the sites and the fact that the site.
<unk> gotten better at screening the patients until the screen fail rate dropped down.
So that's where we stand based on.
Sure.
Actual enrollment now in reach.
Thank you.
Sure.
Thank you.
Ladies and gentlemen. This concludes the question and ask <unk> portion of the call I would now like to turn the call back over to <unk> CEO, Alex for closing remarks.
Thanks to one so just to quickly wrap up we remain as we always have deeply committed to treating the root cause of genetically defined rare diseases and bringing these transformative therapies to patients before we conclude today's call as I always like to do I'd, just like to extend my sincere appreciation and gratitude to my.
Hello, Fulcrum teammates to the physicians, we work with to advance our clinical trials and finally, and most importantly to the patients who participate in our clinical trials as well as their families without them, we would not be able to achieve our goals as a company. Thanks again, everyone, who joined the meeting who joined the call. This morning, and please stay safe.
<unk> and healthy.
Ladies and gentlemen, this concludes today's conference call. Thank you for your participation you may now disconnect.
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