Q3 2022 Provention Bio Inc Earnings Call
[music].
Good morning, My name is Brandon and I hope.
Your conference operator today.
I would like to welcome everybody.
I guess what are 2020.
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I would now like to turn the conference over to Heidi.
Chief legal officer.
Oh no.
Oh.
Thank you operator, and thank you all for joining us.
Ashleigh Palmer, Chief Executive Officer, and cofounder of prevention Bio will first provide an update on our third quarter regulatory interactions and corporate progress before turning the call over to Jason <unk>, Our Chief commercial officer, who will highlight the status of our preparations and.
In anticipation of to prison map potential commercial launch as well as our co promotion agreement with Sanofi.
Jerry show Shea, our Chief Financial Officer will then provide a summary of our third quarter financial results as well as an update on our strategic financing activity before we begin let me remind you that the various remarks, we will make today constitute forward looking statements due.
These include statements about our future plans and expectations in connection with the agreements we entered into with turnkey and the potential commercialization up to pleasant that clinical study results and regulatory and other development and timelines related to our product candidates, including our plans to continue working with the F. D. A.
As they review, our BLA resubmission and continuing our efforts towards securing a potential FDA approval approval for and commercialization of <unk> with the Nab for an at risk indication the potential safety efficacy and commercial success of completed the mad and our other product candidates.
Financial projections, including our anticipated use of cash and our cash runway and our business plans and prospects and projected timing for the state.
Actual results may differ materially from those indicated by forward looking statements as a result of various important factors, including those discussed in the risk factors section of our most recently quarterly report on Form 10-Q and in other filings that we may make with the FTC in the future any forward looking statements.
With that 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 except as required by law. Therefore, you should not rely on these forward looking statements as representing our views as of any subsequent date to today.
Hey.
There is more complete information regarding forward looking statements risks and uncertainties and prevention reports, we file with the SEC.
These documents are available on prevention web site at Www Dot prevention bio dot com under the investors section and we encourage you to review these documents carefully with that I will now turn the call over to Ashley.
Thank you Heidi and good morning, everyone.
Throughout the third quarter. Our team has continued to interact with the FDA in support of our resubmitted breakthrough therapy basic 19 pet please see my BLA.
With the delay of clinical type one diabetes will stage III T. One be in a risk or stage two individuals.
In the major amendment notice we received at the end of June the FDA informed us that if no major deficiencies were identified during its review.
Agency planned communicate proposed labeling and post marketing requirements and commitments.
October 17th.
'twenty two.
I am pleased to report that we have since received both the Fda's proposed labeling and the Fda's proposed post marketing requirements and commitments.
And these are generally consistent with our expectations and public market guidance to date.
Our timely receipt of the Fda's proposed labeling and post marketing requirements and commitments is encouraging.
Nevertheless, we must caution that the SBA has yet to make its final decision regarding the BLA and there is always a possibility circumstances can change.
Agency continues to review our application.
In parallel with our ongoing FDA interactions. We have also been collaborating closely with our co promotion partner Sanofi and preparing for the potential U S commercialization of what might soon become if approved the first ever disease modifying therapy.
P for at risk he wont be individuals with stage two disease to delay the onset of clinical stage three insulin dependency.
Under our agreement with Sanofi prevention continues to maintain control over all aspects of regulatory and commercial strategy for the potential launch of placebo.
Including labeling negotiations.
Packaging distribution and pricing.
Before handing the call over to Jason to further discuss our launch planning and preparations in anticipation of potential approval.
Let me also mention that throughout the third quarter.
Our team has continued to make steady progress across all our auto immune disease focused clinical development programs.
This includes our phase III protocol trial evaluating Pep Lizzie map for new onset P. One day.
Our phase Iia prevail two trial evaluating P O B 30 to 79 for systemic lupus arithmetic basis.
And in partnership with Amgen.
I used to be proactive trial evaluating our anti IL 15, monoclonal antibody or the sick you map.
Nonresponsive celiac disease.
We are also in discussions with prospective partners regarding the next stages of development for our polyvalent Coxsackievirus B vaccine candidate.
The one O one.
With that I would like to hand over to Jason.
Thank you Ashley.
We believe the commercialization team at prevention bio is well prepared for a potential FDA approval decision regarding to pleasant map and stage two at risk do you want to individuals.
Our compass navigator team will be ready to start receiving and processing enrollment forms and the day following approval.
In parallel our field market access team will work with payers on getting medical policies develops in support of coverage for it to pleasant do.
Do we expect will take six to nine months and.
In the early days of launch we anticipate working through the medical exception process for insurance coverage and completely helping eligible commercially insured patients getting rolled in our co pay assistance program.
We have eight therapeutic specialists onboard as a part of our pilot sales team initiated more than a year ago.
These team members will be in the field soon after approval to start educating physicians major centers of excellence and responding to unsolicited requests for education for health care providers.
As I've mentioned on previous calls we were in excellent shape with respect to launch readiness over the summer when we received notice that the delay in FDA review.
We have a fully re initiated all activities related to launch readiness and are prepared for November 17th.
Educational materials contracting with key distribution partners core communication work streams and hiring are on track for our FDA action date.
We're pleased to announce that conditional offers to join US had been accepted by the majority of our planned sales force and we plan to onboard them during the month of December contingent upon FDA approval.
Since our announcement on October six the we're combining forces with <unk> to co promote to pleasant map if approved.
Core commercial and medical Affairs leadership teams from Santa Fe Prevention I've been meeting to ensure that we're ready to go under the terms of the co promotion agreement.
We will be doing some additional recruitment over the next few weeks for the remaining field based positions and continue to be on track to deploy both our team and our new colleagues from Santa and the early part of January .
This planned additional head count from Santos and sets the stage nicely for the commercial launch of Pleasant and we remain excited about our progress during this initial ramp up.
We will be conducting joint training programs with the prevention and scientific teams in December and expect full deployment of the entire team into the field in January .
Finally, it's worth mentioning that I had a chance to attend the international society of pediatric and adolescent diabetes conference a few weeks ago alongside a few colleagues from prevention.
And I have to say there was palpable excitement about the potential for daclizumab among many of the health care providers, with whom we interact with it to meet.
Our symposium at the Congress was standing room, only ran nearly 30 minutes over time with questions from the audience.
We look forward to working closely with physicians patient advocacy organizations and others to bring this important new treatment to market ending our potential receipt of FDA approval.
Now I'd like to turn the call over to Terry to discuss our financials Gary.
Thank you Jason.
Before I begin discussing the third quarter financials I would encourage you to read our 10-Q that was filed today.
The 10-Q includes our financial statements risk factors as well as the management's discussion and analysis of our financial condition.
I would also like to call your attention to the earnings press release, which was issued prior to the school.
Let me start with the P&L.
We generated a net loss for the third quarter of 2022 of $28 $6 billion or 34 cents per basic and diluted share.
<unk> to a net loss of $27 million or <unk> 43 cents per basic and diluted share for the first quarter of 2021.
R&D expenses were $16 $3 million for the third quarter of 2022 compared to $17 $7 million during the same period in 2021.
The decrease year over year was driven by lower costs with the police in my program, including the protect study our target enrollment was reached in August of 2020 one.
This decrease was partially offset by increased cost associated with the enrollment of the proactive trial or they pick them up and prevailed to a trial for P. R V 30 to 17.
G&A expenses were $13 $5 million for the third quarter of 2022 compared to $10 million. During the same period in 2021, driven by an increase in our pre commercial activities.
During the third quarter, we also recognized zero point $8 million of collaboration revenue under our license agreement with one of them.
Our cash based operating expenses for the third quarter of 2022 were $26 $4 million, which excludes noncash stock based compensation of $3 $3 million and depreciation expense of zero point of $1 million.
This number came slightly below the lower end of our guidance driven by our cautious approach to expenses and cash management.
Turning now to our current cash position and cash projection I.
As of September 30th 'twenty, 'twenty, two our cash cash equivalents and marketable securities position was $186 $5 million.
This includes the net proceeds of $57 $2 million from our private placement completed in July .
$23 $7 million from the first tranche of our term loan facility was virtually.
As well that's $33.6 million raised through our at the market program during the third quarter of 2022.
We currently have just over $1 million available capacity on our at the market program and we will continue to be opportunistic regarding the use of this program.
In October under our co promotion agreements with Sanofi, we received a $20 million nonrefundable payment from Sandoz for the right of first negotiation exercisable through June 2023 to research develop manufacture and commercialize depletion map globally in Q1.
These $20 million payment is not included in the cash figure I cited for September 30th and will be reflected in the fourth quarter financial results.
If the police in Ids approved by the FDA and do our securities purchase agreement.
So I know people will purchase $35 million of prevention common stock at a 40% premium to the five day volume weighted average price prior to the closing date with these closing days being at our discretion, but no later than February 16 2023.
In addition, we will have the ability to draw the next tranche under our term loan facility totaling $40 million.
Based on our current business plan, we believe that our current cash cash equivalence and marketable securities on hand, together with capital from Sanofi in her Chile that is contingent on approval enables us to support a successful commercial launch of depletion Mad if approved and provides us with a cash runway through 2012.
Yes.
Please note that this guidance could be changed by the level of success of a potential commercial launch changes to estimated cost of commercialization, including our commitments under the Sanofi co promotion agreement and potential milestone payments.
We continue to be prudent engagement in our spending as we work towards the potential approval if they pick them up and we expect our cash based operating expenses to be between $40 million and $45 million in the fourth quarter of 2022, reflecting an increase in program spend for orders pick them up and P. L U.
Third and seven to nine <unk>.
Well as preparation for the potential commercial launch of the plays out there.
FDA approval in November .
In a scenario where the approval for the police and maybe you can also obtain from the FDA in November we estimate that our cash runway extends through 2024, which is beyond the top line data readout from our phase III protect trial in newly diagnosed <unk>, which is currently expected in second half of 2023.
That's what I was after the completion of how proactive phase II study in nonresponsive celiac disease expected at the end of 2023.
As a reminder, prevention is eligible to receive a $115 million milestone payment from Amgen within 120 days after the delivery of the final data package for the proactive trial shoot Amgen elect to exercise its right to assume control over all activity with respect to orders picking up.
Finally, we believe our momentum with a potential FDA approval of the police the Mab in November provides us with Optionality to take additional capital and we will continue to be both strategic and opportunistic when evaluating potential financing activity as evidenced by our most recent transactions.
With that update I will now turn the call over to Ashley.
Thank you Terry.
Our corporate mission and the strategic intent of our disruptive.
Conceptually platform and clinical stage programs remains firmly focused on catalyzing, a paradigm shift in how our industry and health care system.
Manage serious life, threatening and debilitating autoimmune diseases.
We hope this becomes a reality in the near future with the potential approval of Pep lazy man for at risk individuals with stage two P. M D.
In closing I would like to thank the prevention team and the SBA for all their hard work to bring to please the map as a breakthrough designated clarity to this late stage in the agency's review process.
We hope to receive a positive decision in the coming weeks.
And if approved plans to quickly and effectively bring what would then be the first ever at risk stage, two disease modifying therapy to the Tijuana the community and the precious patients families caregivers and klim missions, we serve.
With that operator, we would like to open the call for questions.
Thank you we will now begin the question and answer.
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Withdraw your question. Please press Star then two.
So we'll talk more importantly.
Our roster.
Okay.
Our first question comes from Justin Kim with Oppenheimer.
Uh huh.
Hi, good morning, and thanks for taking the question great to hear that the company has conducted through expected proposed labeling.
Post marketing considerations associated with the filing.
But I'm just wondering have you conducted any M D.
Sort of discussions with payers and in terms of pricing and do you have any updates or any changes to hobbies and thinking about pricing for a couple of dozen not with a potential launch.
Good morning, Justin Thank you for the question.
I'll hand that over to Jason who has been taking full advantage of the additional review time.
Out of the Amendment, we received at the end of June Jason.
Yeah. Good morning, Justin Thanks for the question really no change as far as we're concerned you know we've completed as I mentioned previously on our calls our pricing research, we haven't set that final price, yet and don't intend to until a final label locked in we would anticipate announcing that final price at.
At the time of a potential approval.
You know as Ive mentioned before though.
So the feedback that we've been hearing from payers over the last three nearly three years has been really consistent payers have told us they anticipate covering two pleasant mab with a streamlined prior off the label, which is precisely the strategy, we're hoping to achieve.
Okay, great great and maybe it's just sort of setting aside the discussions with the FDA on post marketing commitments I know, we've talk sort of in the past about additional studies to broaden the use of tech person that even beyond sort of protect and just wondering.
Are there specific study that the team is sort of excited.
Art, you or initiate even.
Upon a potential approval.
Yeah. Thank you Justin so yes, we were excited.
If we're fortunate enough to get approval to focus on our patients.
Patients below eight years of age to expand our labeling into the younger population.
We're excited about the prospect of re dosing studies.
To determine whether additional dosing.
This additional courses of therapy could extend.
Delays seen from a single course of therapy.
We're excited about the prospect of co administration of Pep, Lizzie mob with a cellular therapies beta cell transplantation.
We're excited about.
The prospects are evaluating kept busy mom.
On stage earlier than stage two at risk patients individuals.
Stage, one who have.
Just to also antibodies.
And beyond that we're excited to explore type leases moms potential.
Outside of type one diabetes targeting other T cell mediated autoimmune diseases.
Such as celiac disease.
Okay, great. Thanks, so much and looking forward to continued progress later this month.
Thank you.
Next question comes from Chris Howerton with Jefferies.
Hey, good morning. Thank you so much for taking the questions and I'm very excited to hear that you have the proposed label.
So I guess the two questions that I'd have for me. It's the first is with respect to the post marketing requirements.
Could you give us any color on what those might be any additional clinical work that could be required that youre expecting.
That's question one and then question two.
We've I've had some confusion I think both with myself and potentially with investors in terms of when we might get to protect data and when the period of the right of first negotiation requires expires excuse me.
So if you could just clarify kind of how to protect data might fact.
<unk> factor into that period that would be great. Thank you.
Thanks, Chris Good morning.
So regarding P M fees and pay them off.
As I said in my.
Great.
<unk>.
Having received them and they are consistent with our.
Prior guidance to the public market.
So to clarify our public.
Market guidance historically.
Has been.
To conduct a pediatric safety study.
And PK PD study in patients in the eight years of age.
As well as to set up a registry to reevaluate.
Long term safety.
And I think that the.
The proposed.
Yeah.
Post marketing commitments post marketing.
Requirements are consistent with that but that's why I also mentioned.
And in the.
And in the opening statement it's.
It's not final in the agency can change its mind at any time.
Regarding the protect study them the right to first negotiation on.
Our guidance has been that we anticipate.
The topline results from the protect study being available in the second half of next year.
We have announced that the right to first negotiation.
Expires in at the end of June of next year, but we've also stated that.
Sanofi can extend that.
Right of first negotiation.
Based on an additional payment.
And that could potentially coincide with.
Evaluating the topline results.
Protect.
Yeah.
Got it so they essentially just to clarify actually and I. Appreciate that is that the Santa Fe could make an additional payment to extend that negotiation period, which would then encompass that youre anticipating that the topline results did do I have that correct.
That's correct.
Okay, Alright, well. Thank you very much I appreciate you taking the questions and again congratulations.
Okay.
Thank you Chris.
Okay.
Thank you.
Next question comes from rents over I do with HC Wainwright.
Thanks very much for taking my question I was just wondering if you could comment a little bit on how you see the specific marketing activities are being planned out and allocated across our prevention and Sanofi in preparation for the launch of.
A pleasant mab.
And if you could also give us a sense of.
Whether there has been any specific.
Updates or revisions to.
To this in the context of the label.
Thanks, very much for the question Ron Good morning, So I'll hand them over to Jason who has been working very hard with our colleagues in Sanofi and preparation and planning.
Jason.
Yeah. Thanks for the question, Rob So with respect to specific marketing activities, you know as I mentioned in the prepared remarks.
Our eight therapeutic specialists that have been in the field for just over a year now we anticipate deploying shortly after a potential approval to start educating centers of excellence and Reactively responding to health care providers, who reach out seeking more information on the efficacy and safety of daclizumab and how to go about acquiring an infusing to close them out.
As I mentioned, you know the things have been progressing incredibly well with our new colleagues at Santa Fe in terms of that that joint deployment. The joint training that will start in early December with the anticipated deployment of both teams in the early part of January now with that being said as we mentioned when we announced the co promotion agreement with Sanofi.
They're deploying a number of dedicated account directors that will disproportionately be focusing on the adult endocrinology segment of the market. While our team disproportionately focuses on the pediatric endocrinology segment of the market that with that being said there will be some redundancy and some complex accounting some centers of excellence.
Academic institutions to raise that level of awareness and we feel that with the nearly doubling of the.
The field presence through our new colleagues insanity, we should be able to really accelerate that level of awareness around a potential approval.
The joint deployment in the in the early to Middle part of January of the the two teams.
Say that you know now that we've seen a draft labeling from the FDA. It really only validates the approach that we're taking with Santa fee. So no changes to our anticipated deployment, our marketing activities. As a result of the labeling discussions that are ongoing hope that answers your question Rob.
Yes, very much so just very quickly on the.
One O one drug candidates Ah I was wondering if you had any updated thoughts regarding the overall strategic positioning of the assets in the context of the commercial availability of daclizumab and ultimately what you think would be the most beneficial or favorable.
Outcome.
Respect of that asset as you look to position it most appropriately.
Yeah.
Got it pretty much run so we feel that that asset is best.
Advanced by.
A party that has a vaccine franchise.
And.
We'll be able to do the advanced stages of development on the commercialization of that so we're actively seeking.
That profile of partner.
We don't really anticipate that there is any conflict between the P. R V. One O one.
Asset and the positioning of.
Lizzy mob for.
Every school nuance that type one diabetes.
In the near to medium term future.
Yeah.
Thank you.
Thank you. Your next question comes from from Smith with <unk> Securities.
Hey, guys. Good morning, Thanks for taking the questions and congrats on all the progress.
Maybe just starting on the ongoing DLA review I appreciate the comments around the proposed labeling and the post marketing requirements.
Sounds like things are.
Progressing really nicely there actually can you just remind us whether theres anything outstanding or gating from your perspective on sort of the manufacturing CMC side.
Yeah.
Yes, good morning, Tom. Thank you, yes, as we had indicated.
Based on the agency's prior.
Decision back at the original <unk> date.
There were outstanding.
Any factoring.
Questions that the agency had.
Which we believe we've addressed in the resubmit the BLA.
And we can anticipate that there will be.
The prospect of post marketing commitments and requirements in regards to advancing the manufacturing.
Process and.
Related assays and so hum in the event of.
A favorable.
A decision by the agency.
Yeah.
Okay got it and then.
Wanted to follow up on the commercial front end and the market access here it sounds like you're expecting some of the payer policies could take some time to implement.
I was wondering if Jason if you could just talk to sort of the tone and goals of some of your recent payer engagement is.
Is it possible you could have some value based agreements already in place at the time of launch that could maybe streamline reimbursement.
Thank you Jason.
Yeah. Thanks for the question Tom.
What we've said previously is that given our given this market, we don't anticipate commercial contracting so.
So you know anytime we're launching with a medical benefit it's going to take time to implement the.
Medical policies are across the payer audience and so our market access directors are gonna be working very closely with medical directors and payers across the board to ensure that you know there there.
Putting in place medical policies to support reimbursement if that wasn't bad now that doesn't mean that while those policies are being drafted patients don't have access. It just means that there'll be working through the medical exception policy.
And you know many if not most medical benefit products are covered by medical exception initially until a policy is put in place. It sounds like it's a big hurdle, but often times it can be relatively quick and easy not all of the time, but you know it just requires a physician to go through a little bit more work and write that letter of medical necessity.
Behalf of the patient in those early days six to nine months as general guidance some can be quicker.
But generally that's about the right time frame for policies to officially be put in place a on the payer side.
Hope that answers your question Tom.
Okay got it yeah, that's super helpful. Thanks, Jason and then just maybe.
Lastly, if you could just remind us or give us an update on kind of the status of the person I have discussions in Europe , and and with the NHRA in what you think the path forward might look like in that region.
Yes, thanks, Tom So generally.
We've.
In the past that are there.
The submission in Europe , and the U K is approximately.
12 months or so behind them and approval here in the United States.
So you know.
Right now our focus is on getting there.
Demand through the final stages of review and hopefully approved by the F. D. A launched.
Effectively with our co promotion partner Sanofi and of course, the right of first negotiation, which.
Uh huh.
I have a <unk>.
Secured with us is.
It is with respect to Pep Lizzie mom.
Type one diabetes on a global basis, and so we anticipate.
Dissipate the beef ongoing discussions and negotiations with.
Sanofi under our right of first negotiation.
Our successful that it.
Bringing in.
A partner like Sanofi into play with respect to.
International.
Market regulatory submissions.
And and potential commercialization.
It would be a very significant development.
Got it that makes sense alright, guys I appreciate the updates and congrats on the progress.
Yeah.
Yeah.
Yeah.
Mmm.
Again, a reminder, that historic guidance is that the labour will.
Generally follow the enrollment criteria of the 10 10 study.
Patience with two auto antibodies T. One the auto antibodies and this glycemia defining.
The patient.
Patients who.
Who are over eight years of age.
And we've tried it in the past that we.
Uhm Hope the agency.
Does not constrained.
Constrain the use of <unk> to only patients with a familiar.
Familiar relatives with existing type one diabetes.
And so.
You know my opening remarks indicated that the proposed label is consistent with that.
And since the historic guidance has not been with respect to an expectation regarding uhm a black box then uhm that that would also be consistent with historic guidance.
Okay. Thank you and secondly on the phase III protect trial, how important is this <unk> likely partners as they make the decision on global out licensing deal and also if you could remind us from a regulatory standpoint is hitting the primary endpoint and therefore, you have to hit on secondary endpoint as well, it's yes, how may.
<unk>.
And which ones would be the most important thank you and congratulations.
Thank you for cough, so I've mentioned earlier, the right assessment negotiation expires in June of.
Next year with respect to partnership with Sanofi, but there is the prospect of.
Gonna be extending that right. The first negotiation into the second half of 2023, when we've guided that the.
Topline results of.
Of the protests study will be available.
Uhm.
In in terms of the protect study.
<unk>.
The primary endpoint versus secondary endpoint.
Will update the market as we get closer to the top line results in.
Our discussions with the F D. A then focus.
On that study and a new one sent patience and assuming that we have been successful in.
Securing the approval of <unk>.
Okay.
Thank you I appreciate the update.
Thank you. Your next question comes from David whole language S. M B C.
Hey, thanks, Thanks for taking the questions and congrats on all the progress you know really great to see that lives a man be close to the finish line ear and looking forward to to produce the date.
Just had a couple of questions just burst in terms of the early launch period, you know something we do get approval soon and you're able to meet the timelines you you specified or commercial launch.
Can you just talk a little bit about you know what types of metrics and kind of color you plan to give ah to.
To help investors to gauge the progress of the early launch whether that be patience goes you know sites offering treatment just those sorts of things.
Thanks, David So yeah, I'll have that question over to to Jason but as you will appreciate.
This is a nascent market and somewhat disruptive federer.
Therapeutic intervention into a space that has historically no therapeutic.
Options, so we have to be.
You know very cautious as to how.
How we assess.
The progress in the early stages, but we do have uhm, obviously metrics that we'll be using to track.
Jason.
Yeah, Good morning day, and thanks for the question. So you know obviously internally, we're gonna be tracking a multitude of different metrics to track launch progress and and anticipated launch success, you know typically and launches I'm always gonna Wanna provide you guys with activity matrix that demonstrate.
Right the the robust activity of the team and engaging health care providers and core stakeholder audience is that you know we know our imperatives during the launch.
In addition to that you know every launches a bit unique every launches a little bit different and so you know while I can't give you the specific metrics that will disclose in the early phases of launch today. The reason why is because I'm not specifically sure which metrics are going to paint that picture for you of how the launch is going and so my my my.
Anticipated intent is to provide you with metrics that paint both a quantitative and qualitative picture of how the launches going so that you can assess how we're doing in the market over time, but I can't tell you today, specifically, what those quantitative and qualitative metrics or that paint that picture for you of how the how the how the launches progressing I know.
That's not a specific answer to your question, but it it at least provide you with the intent of how we're anticipating.
Demonstrating launch progress.
Yeah, Okay I see that that's helpful. Thanks for that and then I just had a question on the you know the coverage and reimbursement front with Payors. I know you know you guys have been driving that that process just curious as to whether you feel sad if he could lend any.
Support in terms of market access where your conversations with payers you know that's something they can contribute to as part of the Copromotion agreement or is that kind of well in hand.
<unk> prevention team and your you know your own efforts in that regard.
Jason.
Yes, absolutely is the answer to the question David you know one of the one of the field based teams that you know as a as a part of the Copromotion agreement is the market access team the the values and outcomes team and so we will actively be partnering with Santa fee on market access and feel base reimbursement as well.
Okay, that's great to hear thanks for taking questions.
Thank you. Your next question comes from Gregory <unk> capital markets.
Hey, guys, it's a Nissan for Greg first of all congrats on the quarter and thanks for taking my question just wanted to get your take on the macro slash clinical landscape from your perspective, when do you expect in office patient visits to return to pre pandemic levels and with this in mind what are your screening expectations for.
At risk to you and B for the to put some out program. Thanks, so much.
Thank you for the question, Jason do you want to take that one.
Yeah, it's like it's a great question and you know I think in office patient visits have already recommenced pandemic from what we're hearing in the field and with respect to screening I think it's a great question I think there are multiple different ways that a patient can go about getting screened today as we've mentioned during previous call.
Auto antibody assays are readily available through commercial labs like lab core in quest, we know through you know data available on quests labs Quest labs, or I'm, sorry, Labcorp website that you know 98 per cent of patients in their database have an out of pocket costs associated with an auto antibody panel of $25 or less than 60.
Five per cent have an out of pocket a zero. So not only is the test available. The test is reimburse. There are also at home options are supported by J D. R F and their T. One to Tech program. So patients that are less inclined to go for an in person physician visit can order a test kit from the comfort of their own home through Tijuana detect.
And have an auto antibody panel conducted you know from the comfort of their kitchen table, which you know against the backdrop of a global pandemic I think J D. R. F. Launching this program nearly two years ago was was was was really well timed, but we anticipate patients being able to get screened and being able to get in to see their physician in person.
Uhm as we potentially roll this drug out in the early part of next year.
Great. Thank you so much congrats on all the progress.
<unk> I would like to turn the conference back over to Ashley Palmer Hurtling equals in Vermont.
Well. Thank you operator, and thank you all for joining today, we look forward to keeping you updated in the coming weeks.
Please enjoy the rest of your day.
[noise] that's offerings Hotmail concluded.
<unk> no no no that's correct.
[music].