Q1 2021 Regenxbio Inc Earnings Call
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Good afternoon, and welcome to the reach of next bio first quarter 2021 earnings conference call.
At this time all participants are in a listen only mode. Later, we will conduct the question and answer session and instructions will be given at that time.
As a reminder, this conference call is being recorded I would now like to turn the call over to Mr. Patrick Christmas Chief Legal Officer of region next bio you may begin.
Good afternoon, and thank you for joining us with US today are Ken Mills, <unk>, President and Chief Executive Officer, and Dr. Steve Nicola our Chief Medical Officer.
Earlier this afternoon, <unk> released financial and operating results for the first quarter ended March 31 2021.
The press release reporting our financial results is available on our website at www Dot <unk> bio dot com.
Today's conference call will include forward looking statements regarding our financial outlook. In addition to regulatory and product development plans. These forward looking statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted and can be identified by words, such as expect plan will may anticipate.
<unk> believe should intend and other words of similar meaning any.
Any such forward looking statements are not guarantees of future performance and involve certain risks and uncertainties. These risks are described in the risk factors and the management's discussion and analysis sections of <unk> annual report on form 10-K for the full year ended December 31 2020.
Comparable comparable risk factors sections of <unk> of quarterly reports on form 10-Q on file with the Securities and Exchange Commission and available on the SEC's website.
Any information we provide on this conference call is provided only as of the date of this call may five 2021, and we undertake no obligation to update any forward looking statements. We may make on this call on account of new information future events or otherwise. Please be advised the todays call is being recorded and webcast. In addition, any unaudited.
Our pro forma financial information that may be provided is preliminary and does not purport to project financial positions or operating results of the company actual results may differ materially.
I would now like to turn the call over to Ken Mills.
Thank you Patrick good afternoon, everyone and thanks for joining us I hope everyone's continuing to stay safe and healthy on.
On today's call, Steve and I will review, our recent progress advancing and expanding our internal pipeline based on our proprietary NAV technology discuss future milestone.
Nvidia is unable to join US today, So I will provide an update of our financial results for the first quarter of 2021 at the end of the call. We will open the line for questions.
To begin I want to express how encouraged I am by the dedication of our team and what they've shown and the progress we've made for our pipeline of AAV gene therapies for patients in the first quarter of this year, we've achieved quite a few milestones we've initiated our first pivotal trial atmosphere to evaluate <unk> hundred one four.
A onetime gene therapy for the treatment of wet AMD and we look forward to moving towards the potential BLA filing in 2024.
We're also evaluating the super parental delivery of <unk> three one for using the SCS micro injector of targeted in office approach and.
We have completed dosing in our second cohort of our ongoing phase III <unk> trial for the treatment of wet AMD.
We also announced that we have expanded the trial to include a third cohort and Steve will walk through further details about that in just a moment.
Our team has also made great strides on our rare genetic disease programs. We're pleased with the continued development and advancement of our Rgs <unk> clinical program for the treatment of MTS.
We recently provided an update at the World Symposium for our ongoing phase one two trial of <unk> one in patients up to five years old and look forward to providing additional data from this trial in 2021, including next week at the.
CCT.
We also announced today that we've dosed the first patient in a phase one two trial in older patients with MTS to where we hope to gain additional insight into the potential treatment effects of <unk> one.
We've recently completed enrollment in the first cohort of our phase one two trial of <unk> hundred 11 for the treatment of NPS.
And our team has also been working diligently towards the unexpected IND submission of <unk> for the treatment of Duchenne muscular dystrophy in mid 2021.
Here at <unk> bio we continue to believe in the promise of our NAV technology and remain committed to the developing gene therapies that improve treatment options for people with serious diseases.
Grateful for the relationships, we forged with physicians patients patient advocates and we're dedicated to supporting them and many other ways as well we participated recently in several events sponsored for instance by the National NPS Society, including the virtual race for care of this past weekend and next week, we will join their annual celebration.
Asian of MPS awareness day, we look forward to connecting with friends and colleagues to raise awareness for these important diseases.
Our recent financial transactions, including the January 2021 follow on common stock offering provide us with necessary resources to continue to advance our lead programs and research pipeline and.
And lastly, just to summarize this week, we've begun the process to move into our new corporate headquarters.
A lot going on so far in 2021 and with that I'll turn the call over to Steve. Thanks, Ken.
<unk> 314 development program for the treatment of wet AMD aims to evaluate the onetime gene therapy.
Across multiple settings of care with the goal of providing access and benefit to as many patients as possible.
I'll begin today with an update on our pivotal program.
As previously announced our pivotal program is expected to include two randomized well controlled clinical trials to evaluate the efficacy and safety of <unk> 314.
And enroll approximately 700 patients in total and is expected to support the potential BLA filing in 2024.
We are enrolling patients in the first planned pivotal trial known as atmosphere.
<unk> is a randomized well controlled trial designed to evaluate the efficacy and safety of our Gx three 2014 compared to repeated ranibizumab of intraocular injection of standard treatment option for patients with wet AMD. The trial is expected to enroll approximately 300 patients and the primary endpoint is non.
Inferiority to Ranibizumab based on change from baseline in best corrected visual acuity at one year pace.
Patients in this trial did not receive any prophylactic steroids beyond what is normally administered after routine vitrectomy.
The second pivotal trial is expected to be similar in design to atmosphere, and we plan to initiate the trial in the second half of 2021.
We have initiated the pivotal program using cgmp material produced from our existing manufacturing process and we plan to incorporate our scalable suspension cell culture of manufacturing process to support future commercialization upon completion of a bridging study which is now active.
This open label study will enroll approximately 60 patients to evaluate two manufacturing process formulations of <unk> hundred 14.
The primary endpoint of the trial of <unk> 314 protein concentration in the aqueous humor at six months.
We are also evaluating the safety and efficacy of <unk> 314, when delivered Super Choroidal <unk> in our ongoing phase III <unk> trial for the treatment of wet AMD.
We plan to reported interim data from the first cohort of patients in the third quarter of 2021.
Day, we announced that we have completed dosing of patients in cohort two.
And look forward to reporting interim data from this cohort in the second half of this year.
As Ken mentioned, we also announced today that we have expanded the trial into a third cohort of patients who are positive for AAV neutralizing antibodies or NAV.
20 patients will be dosed in cohort three with 511 genome copies per eye of RG eight X three of 2014, the same dose evaluated in cohort two delivered as a single injection.
As with previous cohorts patients in cohort three will not receive prophylactic immune suppressive corticosteroid therapy before or after administration of <unk> 314.
This cohort of patients may provide us additional information about the effects of <unk> 314 in NAV positive patients potentially broadening the patient population that could be treated with this in office delivery approach.
Moving on to altitude, our phase II trial to evaluate <unk> hundred 14, supercoil delivery in patients with diabetic retinopathy.
This trial continues to enroll patients in the first cohort and we are on track to report initial data from this trial in 2021.
In our rare disease portfolio, we remain committed to bringing potential onetime gene therapies to patients with rare genetic disease for which there is of significant unmet medical need.
Earlier this year, we announced the development of our Gx two O two of onetime gene therapy for the treatment of Duchenne.
We are working towards an IND filing for <unk> 202, which we expect to submit in mid 2021.
We recently announced that the first patient had been dosed in cohort three of our ongoing phase one two trial of <unk> hundred 21 in patients with NPS to up to age five years.
As reported at the World Symposium Conference in February we have observed encouraging interim data from the first two cohorts, which include signals of the <unk> enzyme activity in the CNS continued neuro cognitive development and evidence of <unk> enzyme activity in the plasma and urine following Archie.
<unk> hundred 21 administration.
We will be providing further program updates later this year, including additional data from these cohorts at <unk> next week.
We're also pleased to announce that the first patient has been dosed in a phase II trial of <unk> hundred 21 for the treatment of pediatric patients with the NPS too over the age of five years old.
Expanding the <unk> 121 development program may provide meaningful insights into the potential treatment effects of <unk> hundred 21 and more patients.
Turning to our phase one two trial of <unk> 111 for the treatment of NPS one.
We recently completed dosing of patients in cohort one.
<unk> hundred 11 is our second product candidate for the treatment of a rare neuro degenerative disease to be dosed in patients.
We believe onetime treatment with <unk> 111 may provide sustained <unk> enzyme for patients potentially preventing the progression of disease and we look forward to providing additional program updates in 2021.
We also recently submitted an IND for the interested sternal delivery of <unk> 181 for the treatment of CRM to disease, after which the FDA notified us in a letter that our proposed trial has been placed on clinical hold and the agency requested more information to support the initial dose selection and <unk>.
Study drug administration procedures.
Our team is currently evaluating the request from the FDA and we plan to provide an update on the program in the second half of 2021.
Based on separate discussions with the FDA around the <unk> three a one program for the treatment of ocular manifestations of <unk>, two and the update from the <unk> Hundred 81 program. We now expect to provide an update on plans for the <unk> 381 program in the second half of 2021.
With that I'll turn the call back over to Ken.
Thanks for those good update Steve.
As I mentioned at the beginning of the call. We're excited that we've started to move into our new headquarters here in Rockville, Maryland, and as we populate the offices and labs will also be completing the build out of the cgmp suites and the new building, which is expected to allow for production of NAV vectors that scales of up to 2000 liters using our platform suspension cell culture.
The process.
While the construction of this new building has been exciting to watch so far we're keenly focused on getting the work in the new facility. The goal of strategically integrating our in house production capabilities with our external suppliers to meet the clinical and commercial supply needs across all of our programs.
Outside of <unk> Bio's walls. We've also been pleased to see the clinical advancement of some of our partner programs utilizing our proprietary NAV technology platform.
Ultra <unk> recently announced the IND clearance of their product candidate for the treatment of Wilson disease.
Dallas has announced that the first patient was dosed in their new trial for patients with late onset Pompe disease. We are encouraged by these examples of advancements by our partners in the AAV gene therapy space.
Now I will turn to the review of our financials.
<unk> ended the quarter on March 31, 2021, with cash cash equivalents in marketable securities totaling $656 5 million compared to $522 5 million as of December 31, 2020.
The increase was primarily attributable to $216 1 million of aggregate net proceeds received from our follow on public offering of common stock completed in January 2021.
The increase was partially offset by net cash used in operating activities of $41 1 million cash used to purchase property and equipment of $31 million in <unk> royalties paid to health care royalty management of $9 5 million.
Revenues were $18 $9 million for the three months ended March 31, 2021, compared to $17 6 million for the same period in 2020.
This increase was primarily attributable to Xeljanz net royalty revenues, which has increased by $8 3 million and was partially offset by a decrease in other license revenues.
Research and development expenses were $39 $7 million for the three months ended March 31, 2021 compared to $37 million for the same period in 2020.
The increase was primarily attributable to personnel cost as a result of increased head count laboratory and facilities costs and clinical trials of expenses for our lead product candidates.
General and administrative expenses were $17 8 million for the three months ended March 31, 2021, compared to $18 4 million for the same period in 2020.
The increase was primarily attributable to personnel cost as a result of increased head count and professional fees for advisory and other services.
Net loss was $50 1 million or $1 <unk> basic and diluted net loss per share for the three months March ended March 31, sorry for the three months of March 31, 2021, compared to a net loss of $40 million or $1 <unk>.
<unk> and diluted net loss per share for the same period in 2020.
As of March 31, 2021, we had approximately $42 5 million common shares outstanding.
Based on our current operating plan, we expect the balance in cash cash equivalents in marketable securities of $656 5 million as of March 31, 2021 to fund operations, including the completion of our internal manufacturing capabilities and clinical advancement of our product candidates into the second half of 2002.
<unk> three.
The focus on our internal pipeline and encouraging process.
Encouraging progress is a testament to the hard work experience and commitment of our entire team. We also look forward to sharing more about our progress using our <unk> technology next week at the American Society of cell and gene therapy annual meeting.
Gene and cell therapy annual meeting one of those meetings will.
We will be sharing multiple scientific posters and presentations showcasing our extensive knowledge across our pipeline and broader AAV characterization.
Given the breadth of our pipeline of gene therapy candidates. The advancement of our first pivotal gene therapy program and our strong financial position. We believe we are well positioned to realize potential security of gene therapies for many patients in need we look forward to keeping all of you updated on our program throughout the remainder of 2021.
And at this time, operator, we are ready to open the call for questions.
At this time, if you would like to ask a question.
The <unk> followed by the number one on your telephone keypad with cash.
All of your question Chris of the pound.
Please standby, while we compile the Q&A roster.
Your first question comes from the line of Geoff Meacham with Bank of America.
Hey, guys. This is alec on for Geoff Thanks for taking our questions and congrats on the progress so far this year so.
So my first question is on three of 2014.
Do you have a sense from you.
Physician interactions.
What an acceptable frequency of rescue VEGF injection would be.
For clinical adoption I mean, taking into account that.
The view I think is three months dosing and first mab is up to four months and I know it may be a bit premature I'm. Considering 214 is just starting to pivotal study, but I'd also be interested to hear your thoughts on how reimbursement discussions for gene therapy in wet AMD are evolving and any color on how you think payers will approach. This.
The rescue injections are still required even in a subset of patients and then I have a follow up.
Hi, Alex Thanks.
Thanks for the question Steve here.
Yes.
Of course have our clinical investigators within our trials as well as our thought leaders in the space.
Other retina specialists that we've kept close contact with over over the years.
You mentioned other products I have come along and incrementally.
Increase the the.
The durability of of.
Of anti VEGF treatment.
There is still clearly a big unmet need.
That exist and what we hear from investigators is and also other retina specialists.
Is if you can have a meaningful reduction in the treatment burden. So you don't have to actually completely obviate the need for any injections, though obviously, we've seen that in a reasonable percentage of our patients.
So really what we're targeting based on discussion with.
Of the retina community is.
<unk>, 50% reduction in anti VEGF frequency.
As well as potentially having 50% of patients needing absolutely no re treatment that has a real homerun for the retina community, both now and also compared to the incremental.
The advancements that are occurring with some of the other treatments that are out there.
Yes, and I think the second part of your question really relates to.
The one of those variables being sort of injection burden and the other being.
Obviously maintenance division and durability overall.
<unk> been really fortunate after we updated on.
On a three year data from cohort three and one of half year data with cohorts four in cohort five at the beginning of the year.
The integrate that into the discussions that we're having as we sort of start are free.
Pre commercial and commercial planning exercise in and I think what I can say is right now I think people are encouraged by what they're seeing they're continuing to have a productive dialogue with us and I think theres a lot of focus on.
Not only the benefit that we bring to patients in terms of.
Offsetting the.
Of the current burden of treatment, but also looking at and the reality of.
The treatment in not just the label paradigm, but certainly the real world use paradigm and Thats, where a onetime treatment of gene therapy really differentiates itself in terms of value, particularly with the data that we've seen in our cohort three out of the three years with patients who have never received an injection.
Thanks for the question.
Your next question comes from the line of Gena Wang with Barclays.
Thank you for taking my questions quite a lot of of programs.
A few questions from volume.
Absolute growth.
The one.
The ceiling complete enrollment of cohort two.
Did you see any emotion.
From patients in cohort two.
Both the profiles from Malaysia to Q1.
And my second questions of regarding the cohort.
Can you remind us nobody tongren cutoff.
T. The.
Commodity titles the rational for Komatsu.
And then regarding the dose of lines.
Sure.
Hum.
Is that because of the protein level stacy or could be.
Jason.
Yes, Hi, Gena.
So we'll take these one by one.
So on the inflammation.
Question. So at the beginning of this year, we had the updated based on the data that we had of <unk> one no inflammation and also guided at the very same time that the next <unk>.
Interim update that we would give would be Q3.
And the reason for that is that we wanted to have.
The full six months robust amount of data on both safety and efficacy.
So we're not.
Changing that that guidance, what we can say is we did complete cohort two and based on where we're at now we were able to advance.
And expand.
The Aviate study to include a third cohort.
With the inclusion of patients who have who are a positive.
Per nabs <unk>, so we feel good about the <unk>.
We are in.
Your question on <unk>.
The single injection wide single injection.
We.
Have the ability with our higher concentration to be able to give a single injection. So in our discussions with.
Investigators and others not surprisingly if you have the choice between the single injection or two injections, one injection would be preferred from a convenience standpoint.
And again based on where we've gone we're very comfortable to be able to go with that higher concentration in a single injection in that cohort.
The the tighter question.
In terms of neutralizing antibodies.
The reality of.
The different assays will have different cutoffs other somewhat of.
Arbitrary for if we were to give some.
The dilution to you what I can say is that we have experience with this from our sub retinal study.
Sure.
As you know, we don't have to exclude patients who have high titers to neutralizing antibody. So in that study of Youll recall, we actually included.
Close to 60% of those patients actually had positive.
The titers, so the threshold that we used.
With that assay and that fits with what's in the literature. So we basically use that same threshold.
For the study with this asset.
Thanks Gena.
Your next question comes from the line of Chip.
With Chardan.
Hi, its full loans of Jun thanks for taking my call.
Just wondering if you had any thoughts.
With regards to the cadence of high high book to me.
The Pan Uveitis and loss of vision from our competitors are using interim vitriol delivery I know youre programs different but.
What are what are your thoughts on why it's sufficiently differentiated so the kols maybe regulators.
We are less focused on the read across non op of follow up.
Hi, Bob.
As with any gene therapy.
And I think even more so in ocular gene therapy. Every program has you have to look at the different variables that are relevant.
We can only say so much about another program, but that's a different factor.
Seven eight and of course administered <unk>.
In the setting of <unk>.
Prophylactic steroids.
Where chronic inflammation requiring ongoing or.
Repeat reactive steroids has been needed for.
Beyond the year.
<unk>.
That has just not been something that has been seen with other gene therapies.
So I think the chronic nature of that inflammation is very different from what's been seen with prior AAV, two or AAV gene therapy.
In sub retinal delivery and even an interim vitriol administration setting so.
We do not see read through.
Although there is the it's unfortunate suits our case.
The reality is in the backdrop of chronic inflammation of these are the.
Negative sequela from chronic inflammation. So our view on this is the same as it's been before of.
Why we picked the our vector and are our product and what we've seen pre clinically and clinically where with <unk> administration of <unk> hundred <unk>, we've not seen chronic inflammation in the transit inflammation has been consistent with the post vitrectomy setting.
Yes.
The Super Choroidal delivery pre clinically and what we've seen to date as well, where we're very comfortable with what we've seen with our particular less immunogenic vector and I think importantly this.
Route of administration, where with the inter vitriol, we know theres anterior clearance of of the vector and the potential to have transduction anteriorly.
And then now with this particular program. Unlike others. This chronic inflammation. So we see this as a very unique setting compared to certainly what we've characterized.
Okay.
Thanks Paula.
Your next question comes from the line of Manny <unk>.
The Blair Inc.
Yeah.
Okay.
Yes, the commodity tour from messenger, Larry Thanks for taking the question guys.
So you talked a little about what you've seen in previous studies of what's in the literature and gone back and forth around the assertion that neutralize the antibodies.
Of the name of my perhaps overstate the impact in this case clinically for you guys.
The purpose of cohort three now we got a little more experienced in the clinic sublet.
What is your view on the prevalence of.
The neutralizing antibodies and the real world as opposed to the kind of historical literature that we've looked at and how the and how successful cohort three effects the opportunity set by expanding into that population.
Hi, Manny.
Thanks for the question.
One of the.
Favorable aspects as we know AAV eight per.
Preexisting neutralizing antibody high titers as less prevalent than say a AAV two so depending on the study as you look at in the.
The thresholds.
The 30% to 40% of patients will be positive for the eight neutralizing antibodies.
Fortunately for a sub retinal route of administration can be totally agnostic to that.
Both as predicted based on the comp.
The.
Privileged status of the sub retinal space and we've actually shown that in our phase one two study where patients who did have.
Positive nabs did just as well from a safety and efficacy standpoint in that trial. So so there its quite simple the and.
Known as with Super Choroidal of delivery.
Well that 30% to 40% of patients that are positive or have higher NAV titers will that have any impact on the safety or efficacy of RG <unk> for via that route of administration, but that's why we decided to go step wise with our Super Croydon <unk> delivery program.
First looking in NAV negative patients in cohort, one and two and now being able to explore.
With the same dose GC per eye.
In patients who are net positive to really assess that question.
Your next question comes from the line of Esther <unk>.
<unk> with UBS.
Hey, guys. Thank you for taking my question.
Just wanted to follow up on the other PP&E.
Where are you on enrollment and is it tracking to the timeline.
Dana.
The firm.
So thanks answer our altitude study is in patients with advanced diabetic retinopathy, and it's actually in patients without <unk>.
And that's intentional because with this in office delivery approach.
The ability to treat patients with sustained anti bad Jeff.
It gives the opportunity to prevent patients from.
Developing sight threatening complications like DMA.
Or proliferative disease.
We have previously.
Guided and continue to guide that.
We'll have interim data by the end of the year. So in the second half of this year. So we're still on track.
Yeah.
As a reminder to ask a question on the go back into queue for a follow up question you Miss you may price.
At this time.
Next question comes from the line of Matthew Harrison with Morgan Stanley.
Hello. This is of course that Sean from Matthew. Thank you for taking my question one question from Us on 181.
Could you provide some color on the tie on hold and specifically how did the dose selection process. In this program differ from your other programs and the how.
How do you expect that pile hole to index the timelines of the two share.
<unk> two programs. Thank you.
Hi, Kosta.
<unk>.
So we received the clinical hold letter with.
Comments and requests for more information regarding dose <unk>.
Selection for the starting doses as well as some specific technical aspects regarding.
The administration.
Each of you mentioned in relation to other programs. Each program gets looked at individually in terms of the overall preclinical package and assessment of an appropriate dose so.
Yes.
We're very.
Excited about how far we've advanced with interest the sternal delivery of AAV nine from our $1 21 in 111 programs. Both in terms of safety Tolerability and also proof of concept in terms of durable expression. So.
That's why we are advancing with our <unk> 181, but again each each program has its own aspects.
We will give an update in the second half of it.
This year, so that we can evaluate the the request in the comments.
The decide on our next steps for <unk> hundred 81.
Thanks for the next quarter.
Your next question comes from the line of Scott.
With RBC.
Oh perfect. Thanks for taking the question. This is Lisa on the Luca.
Congrats on all of the progress made so far.
Just wanted to ask about the Sip of Craig I'll program, and Youre enrolling cohort three with patients with neutralize the antibodies.
Just wondering if you are concerned about inflammation at all in the patient population.
And if so do you intend to offer steroids.
Moving on a prophylactic basis or maybe get the patients.
And the second question.
The Spaniard ask TCT presentation, theres, the poster, suggesting exploration of internet sales delivery.
The library in mice and nonhuman primates.
As you can see the data here in the few days, but just curious.
Interventional delivery is something you intend to start exploring more aggressively for.
From a clinical development. Thank you.
Hi, Lisa Steve here I'll take the first part and Ken can address the ISG Cte.
Rather the administration question.
So yes on C. Three cohort three of the aviate.
Just like cohort one and two there is no prophylactic steroids, either before or <unk> hundred one for treatment or after.
So.
We're excited to be able to expand.
Into that.
Well.
We do the study to see if Nab status would have an impact or not.
Pre clinically we have seen we haven't seen inflammation.
But of course, we have to see.
In humans.
But again, we have no prophylactic steroids in the study.
Traditionally people of.
The thought of NAV is potentially impacting efficacy because of the binding up the.
Youre payload to some extent.
And less on the efficacy on the safety side, but.
<unk> conservatively.
We do the study to see but again, we're quite comfortable going in without prophylactic steroids.
Yes, Lisa on the second part of your question about.
Looking at different routes of administration outside of what we are using clinically today, including in true vitriol and I think we've been open with the fact that.
Our research agenda is broad and we look at all of the possibilities for bringing our different product candidates, depending on the disease and the target tissues for pre clinically in a robust way we continue to.
Olivier Group some great Science, I think we're going to be presenting next week about evaluation of different vector characterization, new types of vectors and across the spectrum of route of administration.
But nothing has jumped out for us in terms of thinking any differently about how strongly we feel about sub retinal.
Being really the gold standard of approaches for targeting the retina with AAV and Thats Super Choroidal was the approach that we decided it was best for an office procedure and that was after evaluating things like interest equal as well as the frankly other device approaches as well for the placement of of AAV in the back of the eye. So.
Always like to show off our good science, and our scientists, but no plans to move <unk> into the clinic anytime soon.
There are no further questions and I will now turn the call back over to Mr. Ken Mills for any closing remarks.
Thank you operator, and thanks, everyone for joining us today.
We've had a good first quarter of the year and look forward to continuing to execute against our plan and our mission to progress the curative potential of AAV gene therapy for patients. So thanks look forward for further updates and have a great night.
Ladies and gentlemen, this concludes today's conference call. Thank you for your participation and the you may now disconnect.
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