Q3 2020 Provention Bio Inc Earnings Call

[music].

Ladies and gentlemen, please standby.

Good day, ladies and gentlemen, and welcome to your prevention Bio <unk> third quarter 2020 earnings conference call. All lines have been placed on a listen only mode and the floor will be open for your questions and comments. Following the presentation should you require assistance throughout the conference. Please press Star zero at this time it is my pleasure to.

Turn the floor over to Mr., Andrew Drexler CFO, Sir the floor is yours.

Thank you operator, and thank you all for joining us on prevention bio <unk> third quarter financial results Conference call.

Joining todays call from the prevention bio team is actually Palmer, Chief Executive Officer and co founder.

First let me remind you that various remarks, we will make today constitute forward looking statements.

These include statements about our future expectations.

Clinical results developments and regulatory matters and timelines, including for the top lives about the L.A.

The potential safety efficacy and commercial success of to put them out in our other product candidates.

Potential COVID-19 impact on our clinical studies and business plans.

Actual projection, including our anticipated use of cash in the fourth quarter of 2020 and cash runway.

And our business plans and prospects, including planned precommercial activities across the company in preparation for the potential approval if that wasn't bad projected timing for the same.

Actual results may differ materially from those indicated by these forward looking statements as a result of the various important factors, including those discussed in the risk factor section of our most recently.

Filed quarterly report on form 10-Q, which is on file with the EPS you see and then other filings that we may make with the EPS you see in the future.

Any forward looking statements represent our views as of today only.

While we may elect to update these forward looking statements at some point in the future, we specifically disclaim any obligation to do so even if our views change there.

Therefore, you should not rely on these forward looking statements as representing our views as of any date subsequent to today.

There is more complete information regarding forward looking statements risks and uncertainties and the reports prevention files with the EPS you see.

These documents are available and prevention website at Www Dot prevention bio dot com under the investors section.

Encourage you to read these documents carefully.

I would also encourage you to read our earnings press release, and our 10-Q that was filed today.

In Q includes our financial statements risk factors as well as management's discussion and analysis of our financial condition.

But that being said please allow me to provide our Q3 financials.

From a p. and L. perspective, we generated a net loss for the third quarter of 31.3 million or 56 cents per basic and diluted share.

Our cash based operating expenses for the third quarter were 28.7 million.

The increase in net loss over the prior year was attributable to the pleasant map related CMC cost protect study costs, yeah la preparation costs.

Pre commercial costs and medical affairs expenses.

As disclosed in our 10-Q, we spent 8.5 million during Q3 on CMC activities.

The significant spend was primarily related to the process performance qualification batches and related analyses.

Enrollment in other activities in our protect phase three study resumed from a pause related the cobot, which resulted in increased clinical trial costs during the quarter.

Also included in Q3, R&D costs with spend related to the P.L.A. preparation and clinical module submission.

Finally, Q3 expenses also included 6 million pre commercial spend and included spend on unbranded marketing and market access preparatory activities as well as personnel cost.

Our net loss for the first nine months of 2020, with 66 million or $1.29 cents per basic and diluted share.

Our cash based operating expenses for the nine months ended September Thirtyth 2020 were 61.8 million.

The spend in the first nine months in particular, the second and third quarters was focused on CMC pre commercial protect study and regulatory activities related to the plus an AD and was driven by our potential marketing approval timelines for tourism and the U.S. and our positive manufacturing progress to date.

As of September Thirtyth, 2020, or cash cash equivalents and marketable securities balance was 147.2 million.

Consistent with our current plans, we expect to use approximately 24 to 28 million of cash.

Operating needs in the fourth quarter of 2020, which is slightly less than Q3, as we continue to scale and ready our commercial organization continue key manufacturing and regulatory activities.

Conduct the Protex phase three study in newly diagnosed C D patients and the proactive phase Twob study in non responsive silly activities.

Build out our infrastructure in preparation for the potential launch of to put them out next year.

We expect that our current cash cash equivalents and marketable securities will be sufficient to fund our operating requirements to potential after FDA approval and the execution of the initial launch it's a pleasant mab, assuming a six month priority review and no significant delays.

With that let me turn the call over to Ashley for an update on to put an AD and other developments Ashley.

Thank you Andy.

Thank you all for joining us today.

So far in the second Tonka's Twentytwenty and despite the extra ordinary challenges companies are facing in the continent Cove it environments.

We've been able to maintain meaningful unreliable progress across all areas of our business.

The most notable recent achievements include the completion of our rolling submission of the biologics license application will be a lady who typically do not put the delay or prevention of clinical he wanted to be in risk individuals.

The launch of our type one diabetes early stage disease awareness campaign.

I want to start today by discussing the anticipated regulatory path forward will typically see Matt.

And remind you of the importance of our disease awareness campaigns and.

And update you on the Protex study under the program.

Yes, Hey, Garanti peptides amount breakthrough therapy designation in August of 2009 team based in part on the London Book 10, 10 study that was published in the New England Journal of Medicine last year.

Data from this study which were included in the clinical module about BLE submission.

Showed that a single cools of pessimism on consisting of a daily 30 to 60 minutes infusion over two weeks.

Significantly delayed the onset of insulin dependent type one diabetes in pre symptomatic patients by a median of approximately two years as compared to placebo.

More recently, but this year is a be a scientific sessions in June.

C. N 10 study follow on data were presented showing the original 14 day cools of capitalism <unk> investigational therapy.

Renewed to significantly delay the onset of T. One be in study participants by a median of approximately three years compared to placebo I think one more year to the previous to your medium delay.

So were even some patients receiving pembrolizumab, who was still T. One the free <unk> eight and a half years.

Not only are these results of the 10 10 study highly statistically significant with a P value of 0.006 tied to the original two year medium delay.

They are also highly clinically relevant.

As such one of the advantages afforded to us under the breakthrough therapy designation what's.

What's the opportunity to submit a B.L.A. on a rolling things.

Earlier this year in April.

We announced that we have successfully in Michigan. This process by submitting the B.L.A.'s Nonclinical module.

This was then followed by our submission of the clinical molecule in September.

Earlier this week, we announced our completion of the rolling submission of the BLM with our own schedule submission of the remaining chemistry manufacturing and controls or CMC module.

The administrative information module.

The agency will now have 60 days to review our submission to determine if the B.L.A. is complete.

Any deemed complete the application will be considered acceptable for filing and review.

Sta will set a prescription drug user fee act will produce a goal date.

I was afforded by the breakthrough therapy designation.

Prevention has expressly requested a priority review in conjunction with our submission of the administrative information material.

The priority review designation means S.P.A.S goal is to take action on an application within six months.

As compared to 10 months understands and review.

I want to commend the extra ordinary determination and hard work of our employees and consultants under the leadership of our Chief Medical Officer Dr. Many Ramos.

And our senior Vice President of regulatory Affairs, Dr. Sharon Rowlands.

[laughter] together led to Pembrolizumab rolling BLE submission with selfless dedication.

We've also laid the groundwork to support doctors as well as patients and their families, making more informed decisions relating to T. One day.

As part of this effort last month, we launched two closely aligned type one diabetes early stage disease and screening education campaign.

Connected by T. One D.

I'm type warm tested too.

To help clinicians and patients respectively begins to redefine patient care in T. One D by creating awareness of the importance for screening individuals.

Disproportionate risk due to a family member having clinical stage disease.

When a type one diabetic patient presents with clinical symptoms for the first time. It is because they no longer have sufficient insulin producing beat to sales remaining in that pancreas to effectively control that blood sugar levels.

Per month, so possibly years prior to this point that he wanted to the auto immunity has been progressing silently.

It is possible to confirm these pre symptomatic process is ongoing flight testing with two or more auto antibodies against certain beat to cell antigens, including insulin itself.

Screening to detect these auto antibodies is currently available through diagnostic companies, such as quest and Labcorp as.

As well as clinical centers of excellence like the Baba's Baby Center for diabetes in Colorado.

Women individually pound have too little more auto antibodies.

He's not a case of it but when they will develop clinical stage T. One day.

I was with a family member with type one diabetes, the risky 15 times greater of developing T won't be done so the general population.

In addition to the educational focus on testing individuals with increased familial risk of developing T wanted to be.

The connected by T. One the campaign targeting.

Targeting clinicians also focuses on educational content regarding the different stages of PD, one PD lone auto immune destruction of beat the cells that because long before symptoms present.

I'll type one tested campaign emphasizes the potential advantages of getting tested and informs pendants and patients how they to arm themselves with additional knowledge. So they can you collaboration within adult to prepare for clinical t. lumpy and make decisions.

Well, maybe increase the likelihood of an acute and potentially life threatening presentation called diabetic ketoacidosis or the 10-K and other serious risks.

Our call to action is early and routine auto antibody screening to identify patients with Presymptomatic early stage type one diabetes.

Buxom at least 64 times in new patients present with T. lumpy for the first time each year in the United States.

There's about 50% of Casey their families first encounter with clinical stage disease. He's DTA, a metabolic crisis that can be serious enough to require a trip in an ambulance admission to the emergency room and several days in a pediatric intensive care unit to stabilize.

As the patient.

After which they likely referred to an endocrinologist for a lifetime of glucose monitoring an insulin therapy with all its accompanying risks and computation.

We look forward to providing you with updates on all connected by T. lumpy and type one tested campaigns.

Other disease awareness and education initiatives going forward.

Looking beyond the potential U.S. approval of Pep lazy man in the risk indication.

We are continuing to prepare the submission of a marketing authorization application or an a to the European medicines agency in 2021.

In addition, we are also preparing potential post marketing label expansion initiatives to broaden pets lives Im ABS market potential.

By exploring younger age groups below eight years of age and evaluating the impact of repeat dosing on the delay in progression of T. One day.

Following closely behind our efforts to obtain FDA approval of our B L. A full 10, plus the amount being at risk individuals. We are progressing protect study in newly diagnosed tea on the patients.

Our goal for protect is the enrollment of 300 newly diagnosed insulin dependent patients aged eight to 17 within six weeks of their initial diagnosis.

Patients will receive 212 day courses of active or placebo therapy administered six months apart.

As you know, we temporarily pools randomization and protect in March and for much of course it too.

I'm pleased to confirm the randomization has now resumed at the majority of sites in quarter three.

However, we continue to monitor the situation that these institutions closely.

As recent increases in COVID-19 cases throughout the U.S. and Europe may understandably impact enrollment.

Finally, with respect to our longer term plans with that lets you know we.

We intend to evaluate subcutaneous eliminations.

As well as they explore potential combinations of Pep lazy man with other therapies.

Losing as an adjunctive therapy to beat the cell transplantation targeting the growing market potential of 1.6 million insulin dependent type one diabetic patients just in the United States alone.

Before we open up the call for questions. Let me provide a brief update on P. RV, Oh, I'm sorry I.

Investigational anti interleukin 15 monoclonal antibody that we're developing in collaboration with Amgen for the treatment of non responsive Celia disease.

Based on prior data, we believe P. hobby 015 has the potential to intercept damaging effects of gluten in patients and has the potential to be the first ever approved therapeutic plus Celia disease.

In the third quarter, we initiated our phase to be proactive study of P. all the one sorry to.

The trial is expected to enroll approximately 220 adults with nonresponsive silly hat disease across approximately 40 sites in the United States, Canada and Europe.

Of note. The study does not require a gluten challenge and patients almost to maintain their usual diet.

In addition to the clinical and regulatory milestones achieved this quarter, we were honored to welcome Dr., John Jenkins to hub board of directors.

As the former director of the office of new drugs at the F.D.A.'s Center for drug evaluation and research, we'll see the duck.

Dr. Jenkins brings tremendous insight as we advanced kept Lizzy mom through the latter stages, the regulators review and potential approval as well as our label expansion initiatives.

Lastly, I would like to call out the November is national diabetes awareness month.

We wanted to extend our deepest gratitude to the patients caregivers and healthcare providers, who worked tirelessly to improve the lives of people living with T. One day and to increase awareness of this serious immune mediated disease.

We continue to be driven by the possibility of bringing the first disease modifying therapy for T. one of the two markets and look forward to continuing to work with the FDA during the regulatory process.

Throughout the remainder of Twentytwenty, we plan to transition them transform our company into a commercialization ready organization in anticipation of the potential launch of capitalism out next year.

In addition to pessimism out our pipeline is rich with potential opportunities to fundamentally address the unmet needs associated with other serious auto immune diseases.

We are passionate about advancing our therapeutic candidates to help those patients and their caregivers.

Now we will open the call up to take your questions.

Thank you.

The floor is now open for questions. If you do have a question. Please press star one on your telephone keypad at this time.

Questions will be taken in the order. They were received if you are using a speaker phone we ask that while posing your question you pick up your handset to provide favorable sound quality. If at any time. Your question has been answered you can remove yourself from the queue by pressing one.

Again, ladies and gentlemen, if you do have a question or comment. Please press star one on your telephone keypad at this time, please hold while we poll for questions.

And our first question comes from Thomas Smith of S.V. Leerink. Please.

Please state your question.

Hey, guys. Good morning, Thanks for taking the questions and congrats on all the progress in the quarter a couple of questions on my end first on the regulatory side for supposing that now that you have the B.L.A. submission completed can you talk a little bit about the timelines that I guess latest thoughts around expectations for potential Advisory Committee meeting.

Good morning, Tom how are you.

Doing well Ashley Thanks, how are you.

Good good. Thank you. So yes, so we know how in the 60 day acceptance.

Period, which we believe will conclude around about the end of this year beginning of next year.

We can then anticipate a 74 day matter that would set out.

The areas that the agency wants to focus on and the review period will begin in earnest at that point.

We don't have any feedback from the agency at this point with respect to an advisory Committee meeting.

But as you can imagine for the purposes of Prudence and preparation we're contemplating.

There will be one for the purposes of of being ready for it and so we as we've shifted now from filing.

It has been all year what.

What I can say is that over the course of the last quarter. We've continued to engage payers and that one to one setting with our market access team year to date, we've engaged or.

A number of payers and I would say in aggregate they represent over 100 million covered lives and what I can say is that the payer feedback has been.

Incredibly positive to date and it's continued to be positive since the first time, we talked about the payer advisory board that we did back in May with medical directors from from.

From a number of plans across the commercial and managed Medicaid space.

We launched.

Prius, Harry payer website to engage them on the burden of illness and burden of disease and will continue to do that over the course of this year and as you mentioned, we're wrapping up Pharmacopeia economic work right now looking at.

Real World evidence study of the totality of the costs associated with type one diabetes those will feed into the budget impact models and cost effectiveness cost effectiveness analyses that will be the foundation of our MCP dossier and the foundation of the pricing research that you you mentioned as well so we still continue to be on track and intend to.

Engage in pricing research in the early part of next year. So what I would say is nothing has changed with respect to our thoughts around price and I wouldn't expect them to until we complete that research and I would expect it will announce the final price at the time of approval.

Okay, great. Thanks, Jason we appreciate the the complex maybe just one last question on some of the pre commercial logistics planning.

Maybe can you talk about some of the work you're doing on the supply chain and distribution side I.

I guess, how do you see.

So closely about being distributed when we think about a potential mix between specialty pharmacies, especially wholesalers.

Yeah, absolutely great question Tom.

Another another question for you Jason.

Yeah, Thanks, Tom sorry, sorry for the interruption ash.

Yeah. Another great question. So we've now moved into the phase, where we've selected our third party logistics vendor were actively engaged in addressing third party specialty distributors.

As well as a limited network of specialty pharmacies that have home infusion capabilities across all 50 states. So while we haven't made final decisions. There. We're in the process of making those selections and would anticipate that will be.

Making decisions on that on those those providers.

Later at by the end of this year early next year at the latest so that we can get through the contracting process I think.

I think there will be a mix between specialty pharmacy and.

And bill at the time of approval, but I.

If I had to guess I would think that more of the of the supply would work through the specialty pharmacy channel versus the specialty distributor channel.

Okay, great. Thanks for taking my questions guys and congrats again on other progress.

Thank you Tom.

Our next question comes from Alicia Young of Cantor. Please state your question.

Hey, guys. Thanks for taking my question Ah Congrats on the progress as we have toward your first really accepted.

Approval I guess, one would be just can you as he kind of continuing to diligence the market.

Kind of talk about some of the challenges the biggest challenges you see maybe from a physician side of kind of change in behavior, there and like how you plan on thinking about in the dressing that.

And then on.

On the Isle 15, and the Nonresponsive Celiac just can you just talk a little bit about that market opportunity and and also like what you're looking for in phase two and how hard has it been maybe in light of Covid or.

Right Buddy like that thing.

Good morning, lethal how ya.

I'm good how're you doing.

Good. Thanks, So Jason again, perhaps you could provide.

Provide the answer to the first question and then hand over to.

Francisco Who's really an expert in Philly huh.

Yeah, absolutely. Thanks for the question Alicia.

So I think to answer your question.

The progress and.

And intend to change position behavior has already begun with the launch of our unbranded disease awareness campaign at the end of last month right. So this campaign is geared toward educating endocrinologists in pediatric endocrinologist on why they should be thinking about screening early and screening often for type one diabetes the risks of not <unk>.

Greening in the family members of those that are already diagnosed who we know are a disproportionate risk of being in the early stages of the disease and trying to change that behavior as early as possible and then I think based on the market research that we've done we've engaged with.

More than 150 endocrinologists in pediatric endocrinologist of that over the course of this year and when we present the profile of of <unk> TPP all of them become incredibly excited and talk about the the paradigm shifting potential that this drug has I would say the one area of concern that that they.

Hawk about is with respect to a 14 consecutive day infusion and as we've mentioned in the past were anticipating and planning for that by.

Ensuring that we have multiple pathways to product acquisition, one obviously being through the specialty distributor one being through the specialty pharmacies, providing home infusion capabilities, having having the flexibility built in if we can to allow for a physician to start a patient under observation an infusion center and then transition them to home.

Infusion, assuming they're comfortable when we get to that weekend infusion time point. So I think we're working actively to address the most common area of concern I think when we presented physician the the potential of having home infusion you see their minds.

Start to be set at ease with respect to that one area of concern.

Thanks, Jason before from Who's Gonna take the call on one five from my perspective, the single biggest inhibitor to the change in behavior has been the absence of.

I'm intervention or therapeutic.

Interception that could.

Make a meaningful difference to the outcome in patients that are identified as having tool to empty body as an early stage disease. So just the availability.

And indeed, the potential of the availability all of the therapeutic interception like kept Lucy map.

Is is a catalyst to change and we're already seeing that capitalist having an impact in terms of the interest level and.

K O L and patient advocacy groups interest in having the relatives of patients with existing type one diabetes screened.

Francisco 015.

Yes, good months.

Also with respect to the commercial opportunity.

As you know celiac disease isn't lost of the large out immune indications, which has no therapy on the market since a very substantial kogelo guestbook market. These effects 1 million.

Americans with Nonresponsive celiac disease out of the $3 million total celiac disease population in the us So a million total possible market.

The trial is.

Four arm.

Those range and face to be trial, which half of primary endpoint symptoms.

<unk> and point that with celiac disease patients who posted outcome.

A key secondary endpoint is got inflammation.

And with respect to cover.

We have a number of initiatives to address the pandemic one inch that as part of his and thus compared requirements to Ah.

She got the inflammation.

Everybody, who I'm Gonna goes endoscopy has at Kobe test. So we came through loud.

And the potential impact of any infection during the trial.

And then nothing to enhance enrollment we had collaborating with the patient support groups.

You may have sand recently press releases issued by beyond Celiac and the Celiac disease Foundation. They are excited of working with us because we are gonna kick nineties drunk has the potential to become the first of her drug approved to celiac disease. So we'll see.

Interesting to try it out.

Great. Thank you that's really helpful. Just maybe one follow up do you think how hard how are the only then.

The kind that to execute David I mean, I guess, you know home health nurse with someone can you just talk a little bit more about those sorts of logistic I do think that's like an important swing backwards.

Thanks to leap year, yes, Jason you've been taking a close look at that with our market access team could you comment.

Yeah, absolutely. It's a great question lately I think there are as we're evaluating specialty pharmacy partners out there. Obviously there are a multitude of them one of the key criteria that we're looking at in selecting that limited group of partners that will be working with is that they have those home infusion capabilities across all 50 states right and ensuring.

They have the caliber of nurses that.

We would want going into a patient's home to be able to conduct these infusions and.

I am confident that we'll be able to find exactly the right providers for that and I think out of the gate I would expect that we will see probably more patients starting in an infusion center. Because this is a new molecular entity to a number of endocrinologists in pediatric endocrinologist with the ability to transfer to home infusion when they get comfortable.

That mix may evolve over time, I would expect it probably would.

But it is a key it is a key criteria and a key.

Element of our search for the the right partners and based on the partners that we've been speaking to thus far I'm encouraged with.

Our ability to find exactly the right partners to be able to to accomplish that home infusion capability.

Okay, great. Thank you that's very helpful.

Any further questions Michelle.

No I'm all set thank you. Thank you.

Our next question comes from Justin Kim of Oppenheimer. Please state your question.

Hi, good morning, Thanks for taking the questions and congrats on the progress, especially in recent filing.

Just a few for me.

With the nationwide screaming and awareness programs ongoing do you expect we might hear any updates from a metric perspective in terms of how many physicians are families patient groups you might be reaching ahead of a.

Launched in 2021.

Good morning, just been thanks, very much obviously very early days, but.

Jason do you have any thoughts about.

When we might have feedback in that regard.

Yeah, He just and good morning. Thanks for the question. So obviously, we're really excited about these two campaigns right one one geared toward healthcare provider's in one geared toward consumers.

And just the quality of the campaigns that have been put out.

I think it's important to note that.

When you look at those two campaigns those the the content of those two campaigns, including the concepts and the messaging and everything that's in there has come from extensive market research with endocrinologist Paediatric endocrinologist.

Caregivers patients themselves and so we really feel it captures the voice of the audience were really looking to engage here that being said our media campaigns are really picking up traction and so I think it's a little premature to talk about any any form of metrics.

We're encouraged with the initial reception and we look forward to providing more details on the campaigns as we continue to gain traction over the course of the coming months and quarters.

Got it and then a confidence.

And maybe just on the piano side, maybe for Andy with the uptick in R&D can can you just give us any additional color on how you think about those expenses going forward.

I know you mentioned.

CNC cost, but just wondering wood creek commercial spurn sort of make up for that.

That sort of going away and how you plan to maybe build up inventory into 2021.

M B.

Yeah. Thanks for the question.

As I discussed on the on the call the CMC costs really around these <unk> batches and all the related qualification validation work that has to be done.

Significantly impacted Q3, and Q to to a certain extent.

We obviously expect those cost to wind down right as we as we wrap up this year.

The transplant Nephrologist and and it has some insight in this therapy from her clinical background. Lenny do you congratulations to you and your team incredible effort, but I mean, it wasn't you know five day eight hour weeks at a time of day weeks it was <unk>.

<unk> our days you know seven days a week to get to a we've way you've gotten us maybe you could answer Justin's question about the potential for uhm adjunctive therapy, with the transplantation of beta cells and and Biomarkers.

Yes, good morning, yes.

Yes, and the ethnic gave it to <unk> to get out of the dungeon. Thank asked me [laughter], but indeed, and the pleasant <unk>, an incredible potential for four and the area of beta cell transplantation in fact this.

<unk> has been tested and I'll itself transplantation.

A decade and a half ago.

So we do have evidence that that it it ah efficacy and a small number of individuals but now we have to you know.

No.

Silicon is produced endogenously produced by the BITA sales as a pro hormone and then its enzymatically cleaved.

Into two units the active insulin that has.

The the the clinical effect in terms of managing blood glucose as a hormone around the body and then the other part the chaperone is C. Peptide. So if you measure C peptide you get.

Very good measure of how much insulin is being produced endogenously as opposed to insulin in the blood.

Screening for subjects.

In Europe, very large console XI as well.

Deep and she'd pad and have them on another probably close to a million.

So to answer your question well all of this is going on in the background.

Possibility of general population screening.

In India.

Uhm countries does has been promoting preventative medicine.

While like like Northern countries channel in Germany.

Already have.

J, how population screening, where oh children are scant at intervals and the well child visits.

And this is now come in to the U S. The ask consortium, it's already a general population screening the prime is consortium in Virginia.

A general population screening program.

As I mentioned, there's a lot of synergy and we can leverage celiac disease to identify more patience with two M D. Because.

Thanks, David So that asset is frequently.

Encountered in the commercial setting already with respect to oncology indications.

Indications Francisco do you want to comment on that.

That and if you consider that to be a barrier at all to us being able to conduct post marketing studies were exhausted T cells may well be a biomarker.

For determining when.

The a repeat dose maybe.

Maybe merited.

Yes.

Thank you also Dave.

Social Dhananjay is conducted.

I said mid teen actually in any tertiary husky, though anywhere where this hematology oncology or infectious diseases.

Frontline what observations with any uhm, let you have on the screening rates for two idea. This at risk population, just giving me the pandemic. Thank you.

Thanks, Greg really appreciate the question and <unk> first philosophically and culturally. This company is of a virtual organization, we're very comfortable with the concept of managing operations on a virtual basis and so it's not foreign two two.

And I believe that gives us an advantage as we know work with Jason that he needs leadership team to think through various scenarios, depending on the situation, which is obviously outside our control in terms of Covid pandemic and the the.

The profile of the sales people that we would want to bring onboard and that the importance of the relationships that they may that they would already have with the target audience of endocrinologist and pediatric endocrinologists and so there are a multitude of factors that.

We will play into our decision, making as we get into next year and we start recruiting the team and we start preparing the tactics for launch that will almost have a parallel path right a pathway, where we are in a covert world and we're launching virtually on a pathway where things.

We've taken into consideration when you're trying to do to remind the price for the police and lab and what could drive the adoption of the drug to Rainier unlocked homes, and what elements could impede the drugs penetration and how do you plan to attack on piece elephant.

First question.

Thank you Jason pricing the elements taken into consideration and the fact is that could drive or impede adoption.

Yeah, absolutely and thanks for the question. So as I think we've mentioned in the past you know we're in the process right now of finalizing a real world evidence study that's looking at both direct and indirect medical costs associated with type one diabetes things like.

A fact.

To the effect of a single admission for a patient and diabetic ketoacidosis can cost anywhere from 18 to $27000 right.

All of the various medical costs both.

Direct medical costs costs of.

All of the treatments all of the continuous glucose monitors pumps tubing et cetera, but also hospital stays things like that will all be factored into this raybould evidence study then we'll take that information.

Input hour.

Are clinical data and model out.

Cost effectiveness analyses quality adjusted life years.

Downstream consequences and all of that will inform our budget impact model cost effectiveness analyses and lay the foundation for our value proposition now that value proposition and those data from.

Ah real World evidence study in combination with now the three year data from HDA.

Will be put in front of payers in the early part of next year in a formalized.

Pricing research study to look at.

What our flexibility may be in terms of pricing.

Obviously, our goal is to get to a place where we have coverage of <unk> with a prior authorization to label as is the case with most specialty products and so that's what will be working toward and that's exactly what the research that will be doing with payers is geared to do will be doing that in the early part of next year, and we'll be able to disclose what the prices at the time of approval.

And Jason a lot of your research to date has been with the two year median come I think things when we get better with the follow on data that was presented at the idea in June.

Yeah, that's what I would actually we did a payer advisory board back in May with a number of medical directors, representing more than 70 million covered lives across our anticipated payer mix between commercial Medicaid managed Medicaid.

And most and most expressed to us they're they're intend to cover with a prior authorization to label.

Which I think was incredibly encouraging to hear the formal pricing research I think we will help inform.

Where we can go with the pricing and what that means in terms of getting a prior authorization a label so.

A number of different scenarios will be tested during that research and.

That will help inform our recently formed pricing committee to make a decision as we get close to the approval date.

And the.

Other than the tool to empty bodies, and this glycemia, indicating that 75% of patients wood.

Two clinical stage type one diabetes, we've been probably.

Is driving adoption.

Are there any other.

That you would like to highlight in terms of the <unk>.

The positive and then what are you what are you going to your eye on with respect impeding.

Adoption.

Perhaps.

You know with multiple dosing for a considerable period of time, if not in some patients indefinitely isn't enormous is a fantastic value proposition and our intent as we mentioned in the in the introductory remarks is to also look at subcutaneous formulation.

Actions to.

Further improve the situation.

Ladies and gentlemen, this does conclude our question and answer session Mr. Palmer I will turn the conference back over to you for closing comments.