Q2 2022 GlycoMimetics Inc Earnings Call
Good morning, and thank you for joining the glycol. The medics Q2, 2022 earnings call. At this time, all participants are in listen only mode.
Following management's remarks, we will hold a question and answer session and at that time the lines will be open for you if anyone should require operator assistance. Please press Star then zero on your Touchtone telephone.
I would now like to turn the call over to Christian Dinneen Long company counsel at like all the medics. Please go ahead.
Good morning today, we will review our business updates and financial results for the quarter ended June 32020 to the press release, we issued this morning is available on the company's website at <unk> Dot com under the investors out there.
This call is being recorded.
Dial in phone replay will be available for 24 hours after the close of the call the webcast.
A replay will also be available for 30 days in the Investor Relations section of the company's website.
Joining me on the call today from glaucoma medics are hurts emerge Yan Chief Executive Officer, Brian Hahn, Chief Financial Officer, and Bruce Johnson, Chief Commercial Officer.
I'll start today's call with comments from her at who will provide a broad overview of the business and the progress of our pipeline programs followed by commentary from Bruce on the potential market opportunity for Ya Berlottes, along Brian will then provide detail on the company's financial position and will open the call for Q&A.
I'd like to remind you that today's call will include forward looking statements based on current expectations forward looking statements. On this call may include but are not limited to statements about the companys product candidates <unk> GMI 16, 87, and our other pipeline programs along with statements about expectations regarding our operations cash position and data from preclinical.
Nickel studies or clinical trials as well as planned our potential future development regulatory interactions or submissions and potential pre commercial perfect commercialization activities or strategic collaborations.
Such statements represent management's judgment and intention as of today and involve assumptions risks and uncertainties glaucoma medics undertakes no obligation to update or revise any forward looking statement for information concerning the risk factors that could affect the company. Please refer to <unk> filings with the SEC, which are available from the SEC.
On the glaucoma that ex website I'll now.
Now I'll turn the call over to hear it.
Thank you Christian and good morning, everyone over the past quarter, we have continued to ramp up our regulatory and commercial readiness activities as we advance the development of our lead program Youre, perhaps around currently in a phase III Registrational trial in relapsed refractory acute myeloid leukemia or AML and continue.
You're building a strong foundation for our potential evolution to a commercial stage company <unk>.
Experienced and dedicated leadership with a track record of successfully commercializing oncology and hematology assets is crucial to this evolution.
Is why we are excited we're excited to have Bruce our chief commercial officer on today's call to share additional detail on these ongoing efforts.
First however, let me provide an overview of the business.
As shared last quarter, one of our top priority is continues to be cleaning the data from the 70 sites and 388 patients participating in our phase III clinical trial across the U S Europe , Canada and Australia.
The placebo controlled trial is evaluating salvage chemotherapy with or without <unk>.
Recall that the primary endpoint of this trial is overall survival and as we have previously disclosed the phase III trial was powered at 90% to detect a hazard ratio of <unk> six eight or better.
Today for the first time I would like to share an overview of the patient demographics from our phase III trial.
When designing our phase III trial, our goal was to generally reflect our phase one two patient population and exclude patients that are not likely to benefit from the therapy.
I'm pleased to say that phase III population is broadly similar to that of the completed phase one two study with respect to age severity of AML prior stem cell transplantation rates and distribution of relapsed and refractory patients.
The median age was 58 years old 33, 5% of the phase III participants were refractory patients with the other 66, 5% falling into the relapsed category.
After relapsed patients 19% of the phase III population had a prior duration of remission less than six months in.
In terms of prior therapeutic background of this phase III population, 18% previously had him up the top biotech stem cell transplantation or HFC.
While 16% had undergone more than two induction regimen.
Yeah land risk stratification was broadly consistent with phase one two population.
For a more detailed breakdown you can find the full patient demographics table in our earnings press release.
But bottom line is the patient population enrolled in the phase II and into phase III programs with your price ran in the relapsed refractory setting are broadly similar and reflect the patient population clinicians are seeing in their practice.
As for the timing of the event trigger.
We have previously disclosed our projection of mid year 2023 for this milestone with disclosure of the topline data results. Shortly thereafter, we.
We will continue to monitor events and provide appropriate updates to this projection as needed.
As a reminder, we have already been granted FDA fast track and breakthrough therapy designation for you for restaurant in the relapsed refractory AML, allowing us to rapidly move to regulatory submissions.
As we draw closer to this milestone next year, we remain confident that by disrupting the protective interaction within the bone marrow microenvironment <unk> has the potential to transform outcomes in AML patients by hopefully achieving deeper more durable remissions higher rates of measurable.
Residual disease, <unk> negativity bridging more patients to potentially curative stem cell transplants, and ultimately improving overall survival.
In addition to our phase III registration trial <unk> is also being evaluated by the National Cancer Institute or Sci and an independent randomized open label trial in frontline newly diagnosed AML patients, who are 60 years and older.
This clinical study is evaluating whether the addition of your cholesterol.
Standard Cytarabine diary of a sand regime.
Seven plus three and older adults with improved patient outcomes.
The phase II portion of this phase two three trial completed enrollment of 267 patients last November and as per protocol that the NCI has suspended further enrollment in anticipation of its planned interim analysis.
When the outcome of the Ncis event free survival analysis of the phase II trial is communicated to US we plan to issue a press release.
To be clear the NCI trial gives us the opportunity to demonstrate benefit in a distinct patient population and potentially expand our label to include frontline AML.
I'd also like to reiterate that in addition to advancing two registration stage programs. We have several investigator sponsored trials currently evaluating <unk> potential. In addition in additional hematologic indications.
Indications.
Studies are underway to demonstrate the benefit of adding <unk> to have an interclass HMA combinations and patients ineligible for intensive chemotherapy as well as in combination with salvage therapy for secondary or treatment related AML.
We continue to collaborate with the principal investigators of these trials with our mutual goal of publishing their findings at major medical meetings.
These trials provide glaucoma metrics with the opportunity to expand the potential application of your for restaurant into additional areas of unmet medical need and we are greatly appreciative of our investigator partners for their efforts to advance this goal.
We believe the enthusiasm of clinicians to engage with you plus run in this manner reflects both the high degree of unmet need in this patient population and the exciting potential that <unk> has to address these gaps in the care continuum.
Our pipeline of innovative black of biology based therapies extends beyond your <unk> and I would now like to turn to recent updates on the progress we have made with our sickle cell disease program GMI $60 87.
I am pleased to report that the FDA accepted our IND application to proceed with a phase one clinical trial of GMI 16, 87 in healthy volunteers.
While we are encouraged by this positive update in line with our existing business strategy. We are focusing company resources on your per restaurant development and potential commercialization.
Consistent with our past communications with this IND acceptance. We believe 16 87 is well positioned for partnership to further advance this promising molecule.
As a reminder.
<unk> seven is a highly potent E. Selectin antagonist initially being developed to treat acute <unk> occlusive crisis or frame crisis in sickle cell disease patients.
E. Selectin is believed to play a major role in the Cascade of events, leading to cloth and blockages that caused patients pain crisis, which could ultimately lead to event.
A stroke or permanent organ damage.
Because <unk> 16, 87 offers the potential for self administration, and then injectable subcutaneous dosing form via a pre filled syringe or auto injector. It could be administered at the onset of the pain crisis to disrupt the underlying inflammatory cascade and restore.
Normal blood flow potentially blocking damage and paying created by occluding blood flow to the Oregon.
Given that there are currently no FDA approved therapies in the treatment of acute voc's and sickle cell patients. We are optimistic about the promise of this program to address the high unmet unmet needs and long term health consequences for this population.
Despite recent advances in the treatment of sickle cell disease, the impact on reducing on reduction of frequency and severity of the <unk> has been limited for the nearly 100000 patients and yes, we look forward to continuing to provide updates as we review potential next steps.
This program.
As we continue to advance the phase III <unk> trial, two words, it's overall survival events trigger currently expected in mid 2023 and make progress across the rest of our pipeline with the recent acceptance of our IND application for our next asset <unk> 677, we.
Have established strong momentum and our continued evolution to a commercially focused organization.
We are hard at work preparing for you for restaurants anticipated market entry and I'd like to hand, the call to Bruce to provide detail on the team's early commercial development work the market opportunity as well as an overview of the current AML landscape Bruce.
Thanks Farooq.
Thanks to everyone for joining our call today.
I'd like to discuss <unk> potential market opportunity.
By providing some background on our early commercial development efforts.
As well as further context on the AML landscape and the limitations of existing standard of care therapies.
I'll close out with some insights into why we view <unk> as a therapy that we hope soon.
<unk> positioned to.
To disrupt the market in serious need of transformation and address the unmet needs of AML patients.
The focus of our early commercial development efforts has been in four key areas first.
First to drive awareness and educate medical experts on the role of E. Selectin in AML and how this glycoprotein on the endothelial surface of the bone marrow vasculature creates a permissive microenvironment per leukemic cell survival and proliferation.
Second to raise awareness of <unk> unique and differentiated mechanism of action as a first in class E. Selectin antagonist poised to disrupt the standard of care in both relapsed refractory and newly diagnosed AML fit for intensive chemotherapy.
Third to drive awareness of <unk> clinical development program in AML and fourth to develop a deep understanding of the market landscape in the U S. EU U K and Canada, the commercial opportunity for you for less one and to evaluate early perceptions of a blinded product profile with AML experts.
Community, Hematological, oncologists or Haemonchus and Payors.
To date, we've conducted extensive primary and secondary market research to understand the AML landscape and the limitations of existing standard of care therapies. This includes target product profile or TPP primary market research with both academic AML experts and community based T marks.
All experts included where investigators and trials published research in AML and we're involved in regional or National guidelines. The objective of this research was to gain physician insight into newly diagnosed and relapsed refractory AML treatment landscape.
Current unmet medical needs and how the future AML landscape will evolve.
We also wanted to obtain reactions from AML experts and community. He marks to a potential TPP that might address the unmet medical needs with a focus on efficacy benchmarks and expectations for clinical use to provide some background AML is one of the most common types of leukemia in adults with a global median.
Incidence rate.
Of almost $2 three cases per 100000.
In the U S. There are estimated to be more than 55000 people currently living with AML and more than 20000 adults in the U S diagnosed annually.
Study presented at the National comprehensive cancer network or <unk> annual conference. This past March indicated that the incidents of AML and deaths among AML patients are increasing worldwide.
Despite recent advances AML. Unfortunately remains an area with significant unmet need long term patient outcomes are poor with roughly 70% of newly diagnosed patients relapsing within three years and a disappointing five year overall survival rate of 29%.
In terms of current standard of care therapies AML is a chemo sensitive disease in the main treatment for this patient population is chemotherapy. However, however, chemotherapy is not targeted and often results in residual leukemic cells that may result in relapse.
Beyond chemotherapy many of the newer therapeutic options for AML are limited in their ability to achieve deep durable complete remissions or have toxicity concerns. These therapeutic options are also often used for a select few patients who harbor specific biomarkers limiting their utility and broader.
<unk> compounded by these factors there is no standard of care treatment regimen for relapsed refractory AML patients eligible for intensive therapy as one expert recently stated we are not carrying a lot of people with AML certainly not without transplant.
When treating AML.
Our goal is to put the leukemia into complete remission with bone marrow and blood cell counts returning to normal.
Recently measurable residual disease or <unk> negative status has emerged as an important prognostic factor for longer survival and decreased risk of relapse post allogeneic stem cell transplant.
Illustrating that point the five year overall survival rate for patients who are <unk> negative is 68% versus 34% for those who are <unk> positive. Similarly, the three year relapse estimate is 22% for <unk> negative patients versus 67% for <unk> positive patients.
<unk>.
Current end CCN recommended regimens achieved complete remission with complete hematologic recovery in 20% to 30% of relapsed refractory patients MLD negativity and only 15% to 25% of patients an allogeneic stem cell transplant rates of only 20% to 30% of patients in <unk>.
Relapse.
The median overall survival period is approximately six months and the population evaluated in these studies.
Feedback from AML experts indicates that large well controlled randomized clinical trials, establishing novel agents in this setting will help redefine a new standard of care.
As part of our effort to understand the email market. We continue to see strong positive response to a blinded product profile for both relapsed refractory and newly diagnosed setting in blinded TPP primary market research with AML experts community <unk> and payers in the U S EU UK and Canada.
All physicians interviewed express a high level of interest in the E Selectin mechanism in.
In relapsed refractory setting physicians would add a product matching the blinded TPP to intensive chemotherapy, if it exceeded their CR rate and OS threshold for use in clinical practice and first line median OS or median overall survival is the most important endpoint physicians found the overall survival benefit.
<unk>.
As the inflection point for use in their clinical practice.
All respondents rated the blinded TPP favorably and felt that it would be a significant advance to have a new drug with a non overlapping mechanism of action that when added to standard therapy could aid in achieving deeper more durable remissions higher rates of <unk> negativity and improved overall survival without <unk>.
Added toxicity.
As new therapeutic options emerge the prevalence of relapsed refractory AML will likely increase over time and on average patients will receive greater than two to three lines of therapy over the course of treatment.
As a result of this trend novel agents that can enhance the effects of currently available therapies and bridge more patients to potentially curative options such as allogeneic stem cell transplant could be a major treatment advances.
Therein lies what we believe is a significant opportunity for <unk> to potentially transform outcomes in AML, if we achieve our target product profile.
In combination with salvage chemotherapy, we believe that <unk> has the potential to be the first regimen in over 25 years to demonstrate broad clinical benefit in relapsed refractory AML, regardless of cytogenetics or mutational status.
Based on available publications, we estimate in the top seven markets. There are over 25000, relapsed refractory AML patients of which about 40% are eligible for intensive therapy, such as a potential regimen of <unk> plus salvage chemotherapy.
We are successful in our current phase III trial and achieve our TPP, we envisioned pursuing development of <unk> for AML patients, who are not eligible for intensive chemotherapy, which according to our estimate could more than double the market opportunity and depending upon the results of the NCI study. We may also explore that.
Significantly larger frontline AML market opportunity.
So in summary.
Assuming we achieve our label consistent with our TPP, establishing you for less one in combination with intensive chemotherapy in both relapsed refractory and newly diagnosed AML is the first phase of our multi phase lifecycle management plan for our E selectin antagonist portfolio physician awareness enthusiasm.
And willingness to prescribe a novel therapy that is consistent with our target product profile is already present the market opportunity is significant and having spent the past 20 plus years focus on launching products in the AML Arena I am quite excited by this opportunity and look forward to further exploring the potential to.
Spanned into additional indications down the line broadening our reach into additional patient populations in need of innovative treatment options.
Brian I'll now turn it over to you to provide an overview of our financial results. Thank you Bruce as of June 32022, <unk> had cash and cash equivalents of $60 $2 million as compared to $93 million as of December 31, 2021, we continue to expect our current cash resources will fund our operations into the third.
Third quarter of 2023.
The company's research and development expenses decreased to $8 million per quarter ended June 32022, as compared to $10 2 million for the same period in 2021 the.
The decreased expenses were primarily due to lower clinical trial costs related to our ongoing global phase III clinical trial of <unk> land and individuals' with relapsed refractory AML.
With the completion of patient enrollment in November 2021, clinical sites are being closed as data collection and cleaning to occur.
As the phase III data matures, we will continue to closely manage our R&D costs to ensure that we are appropriately allocating resources potential commercialization of <unk>.
The company's general administrative expenses increased to $5 $5 million for the quarter ended June 32022, as compared to $4 2 million for the second quarter of 2021, primarily due to commercialization startup expenses for U S land and other administrative expenses, resulting from the easing of Covid restrictions.
I'd now like to turn the call back to <unk>. Thank.
Thank you, Brian as I approach the one year anniversary of my appointment as CEO I'm more excited than ever about our company's transformative work, particularly as we gear up towards a significant inflection point expected in 2023, where.
We look forward to providing further updates on our clinical pipeline as we pursue our vision and continue our evolution into a clinical into a commercial stage company capable of delivering these therapies to the patients who need them most and we deeply appreciate your continued support.
I'd now like to open the lines for Q&A operator.
Thank you as a reminder to ask a question you will need to press star one one on your telephone.
Please standby, while we compile the Q&A roster.
Yes.
Okay.
One moment and our first question comes from Boris <unk> of Cowen. Please proceed.
Great. Thanks for taking my question first I just wanted to ask on new Pro Phase III trial are the enrollment obviously completed in November of last year. Just curious if you could comment on how the OS events are tracking versus projections.
Yes, Thank you Boris and good to hear your voice.
And just as a reminder for everyone that we have completed our enrollment in our phase III in November 2021, and we are projecting a overall survival events maturing in mid year 2023, So Boris that's that's kind of.
It's still tracking in line with our previous projections.
And but at the same time you know this is all projections. So we're continuously monitoring it and making sure that if there are differences that we communicate them appropriately with time. So at this point, we're still tracking towards that mid 2023.
Got it and my last question Eric.
You mentioned there are a number of <unk> studies testing in a combo with <unk> I'm curious what would we see some initial results from that combination.
Excellent question as well.
So well one of the one of the.
Several <unk> that are going on is.
As the combination with Vantiv facts and HMA, obviously, the principal investigators are.
Are responsible for their own data and when do they presented.
So we don't have a clear guidance from them when they plan to do with that.
Having said that Boris I wouldn't be surprised if we start seeing some of this data starts coming in.
I would say even as early as this coming ash.
Given that these are some of them are open label trials. So.
We stay tuned, but I wouldn't be surprised if I start seeing it then.
Great. Thank you very much for taking my questions.
Thank you one moment here.
Okay.
Our next question comes from Roger song of Jefferies. Please proceed.
Great. Thank you for taking the question.
Yes, maybe a hurdle it's very helpful. You provided the baseline characteristics for the phase III.
Can you just I understand.
In bras joke.
The characteristic seems broadly similar between 301 and two but when we look at the granularity we do see some difference in terms of like duration of prior remission in the prior.
Greater than two induction and also the <unk> and.
Our risk characteristic.
Category.
More favorable than the less diverse so would you characterize the C 301 less.
The rest of year.
Since the patient baseline compared to 201 slightly also how would you compare 301 study versus the historical steady using chemotherapy, Austria seven press three.
Yes excellent questions. Roger Thank you, yes, I mean, when we take a look at our patient characteristics Roger what we're characterizing it as we're saying it's broadly similar with our phase III.
And it is not exactly similar to your point, it's broadly similar.
I would say a couple of things about that keeping in mind that <unk>.
For example, as I said, it's quite similar to the distribution of relapsed and refractory are quite similar.
The vast majority of the patients in both in both trials have a an adverse risk.
Category, one is 40%.
50%, 50% rather than the phase 240% is in the phase III keep in mind, Roger that the phase II was a handful of sites NDS with 66 patients.
While the phase III is 388 patients 70 sites across the world. So a few percentage points a couple of patients here and there can make a big difference in the percentage number on the phase II.
So that would be one one comment and then the second comment I would say is.
That's not.
Get that all these are relapsed and refractory patients AML patients, whose prognosis or in months. Unfortunately.
So that's kind of why when.
When you put all these things together, we believe they are broadly similar to each other and they're broadly similar as well with other therapy with other trials in the marketplace. We have done a deep dive on that as to what our different trials in the marketplace and we're coming up with is it broadly similar patient population in there.
And the control trials.
There are a handful of trials out there as well as we are aware of.
That our retrospective in nature or a single site in nature that might report a bit of different outcomes, but thats kind of where it is important too.
Look at let's say.
Age groups.
Obviously, you would know 58 year old patient can be quite different than a 50 year old patient and so on so forth. So we think that's kind of a long winded answer to your question of they're broadly similar.
The phase II and also too.
Historical market practices.
Got it yes, that's very helpful.
And in terms of the.
The NCI study.
Understanding they are controlling the data and clean up the data right now, but how often you will get update from STI.
They give you the lack of real time update.
And to the point they will say okay. This is the final data in the U K.
Issued a release.
Yes, so our our working methodology with the NCI is that once they complete their.
Analysis, then they would give us.
The go ahead with that so without without them completing the analysis, we wouldn't get any updates from them Roger.
And.
That's something that they have not communicated to us when will they do that.
We're looking at it from the outside in obviously as a reminder for everyone on the call as a primary endpoint of the phase II portion of this phase two three adaptive trial is CFS and generally speaking.
<unk> reads out faster than Oss.
They have enrolled 267 patients more or less the press release for the full enrollment of the phase two NCI trial was within two weeks of our own trial. So both trials.
But at the same time one is in <unk>. One is in Oss, we're saying the Oss mid 'twenty three.
So.
From our perspective, we think it will be before that obviously, but they havent officially communicated what we are committing is once we have that we will issue a press release.
Excellent.
Does that answer your question Roger.
That's very good thank you maybe.
Maybe just ask one last one from us.
In terms of the BD activity now.
Now you get sick.
87, with the R&D and also you have a couple on their asset in the pipeline and <unk> partnership.
Any comments around the BD progression and then noted seeing the cash runway is in Q U a potential phase III data readout, what this BD kind of or ahead of this cash runway and then you can extend further.
Thank you Roger so.
Obviously, it remains a clear focus so maybe.
A couple of things about <unk>, 87, and where we are.
Very excited about this program sickle cell disease remains one of the diseases, where.
There is high unmet medical need there has been many attempts different.
Therapeutics coming into the market.
Unfortunately, what we're seeing is on the patient level.
100000 patients in the U S continue the vast majority of them continue to have <unk> occlusive crisis. They know the pain is coming in.
They have minimal options to do something about it so coming up with a new therapeutic option.
<unk> patients do not have to end up in the emergency room. They are able to take this subcutaneously available.
Auto injector offs or something of that sort is really something very motivating for us.
They're shipped.
It's very it was very important for us Roger to have the IMD under our belt because as you can imagine that changes quite a bit the the partnership discussions when we have that the FDA.
Two to proceed into patients.
We are working hard on that but I want to reiterate that.
We're only going to seek quality partners, we're not just a line from a financial perspective, but also with their commitment to this patient community perspective, Roger So that's going to be very important.
The second part of your question given the cash runway.
Market has.
All of us into a much more clear way of how do we should we prioritize our activities and our our company.
Cash and we're really doubling down on your philosophy at this point, we see that light at the end of the tunnel.
We see the phase III data maturing.
And we want to make sure that we're well prepared and well positioned should that data will be positive that we were able to activate everything possible to get it to patients as fast as possible. So that's why we're preserving our cash to focus on that while seeking additional opportunities for <unk>.
At 16, 87 or be at $13 50, 960, 87 is the third asset we're going to get into the clinic hopefully soon with.
With a partner whenever that comes we will communicate it.
Excellent. Thank you Harold.
That define us.
Thank you Roger.
Thank you one moment.
Our next question comes from Ed White of H C. Wainwright. Please proceed.
Hi, This is Steve on for Ed way first question on the recent workforce reduction has that been completed.
And should we expect to see any.
Quarter over quarter expense reductions during the year.
Yes, thank you for that.
Take the first part of your question and maybe Brian Hahn, our CFO can weigh on the second part.
So we have reduced our.
Workforce, particularly in the early research team, that's kind of where.
Now that we have multiple assets coming.
From our pipeline, we think we have enough at this point to really focus on pulling forward, our phase III and beyond so that was the intent of it.
Wasn't meant for a significant reduction in cost, but rather a re prioritization of investment from the early bench science part of the organization more into the late Medical Affairs commercialization regulatory affairs parts of our organization.
<unk>, which is really important but what would the impact be from a financial perspective, Brian do you want to comment on that thanks, Steve We've been as noted we've been burning about $15 million a quarter and again with some of these reductions.
Not a material impact on cash burn so I would anticipate maybe a slight decrease but not much.
Alright, thank you.
Okay.
Thank you as there are no more questions in the queue I would like to turn the microphone back to Mr. <unk>.
Thank you very much operator, I would like to thank you for your time and attention as a reminder, in September we're planning to be in person at the HC Wainwright Global investment Conference in New York I look forward to their one to one meetings that will be scheduled and to keeping you updated on our progress and outlook.
Once again, thank you very much everyone for joining our call.
This concludes today's conference call and you may now disconnect.
Okay.
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