Q1 2022 Aadi Bioscience Inc Earnings Call
[music].
Greetings and welcome to the Aerie Bioscience incorporated first quarter 2022 earnings conference call.
At this time all participants are in a listen only mode.
Question and answer session will follow the formal presentation.
If anyone should require operator assistance during the conference. Please press star zero on your telephone keypad.
Minder This conference is being recorded.
It is now my pleasure to introduce your host Andrew Quant VP of business development and corporate strategy. Thank you you may begin.
Welcome everyone to the first anti Bioscience quarterly results call for Q1 2022.
With us on the call today from Eddie Bioscience R. Neal the Si founder President and CEO , who will give a quick overview of the quarter.
And then Delaney Chief operating officer, who will provide early commercial uptake commentary and metrics I'll start a little bit of M. E tree, Chief Medical Officer, who will walk us through clinical development priorities and forthcoming updates and Scott Cabello, Chief Financial Officer, who will provide an overview of our financials this quarter.
Before we get started I would like to remind everyone that statements. We make on this conference call will include forward looking statements actual events or results could differ materially from those expressed or implied by any forward looking statements. As a result of various risks uncertainties and other factors, including those set forth in the risk factors section of our annual and quarterly filing with you.
Security and exchange Commission and can be found at Www <unk>.
S T C dot gov or on our website at Www Dot added bio dot com and.
In addition, any forward looking statements made on this call represent our views only as of today may 12.
'twenty, two and should not be relied upon as representing our views as of any subsequent date we.
Specifically disclaim any obligation to update or revise any forward looking statements.
That let me turn the call over to Neil.
Thank you Andrew and good morning, everyone and thank you for joining.
The first quarter of 2022 was transformative for IV Bioscience, we successfully transitioned into a fully integrated biopharmaceutical company commercializing and launching our first product firearm and albumin bound <unk> inhibitor also known as natural all of us or advanced malignant Tacoma on February 22nd.
Of this year.
We delivered on our promise to begin enrolling patients in our new registration directed tumor agnostic trial known as precision one in March.
In the first quarter, we have continued our company building and recruitment of high quality talent in all areas of the organization.
And our cash position remained strong at approximately $130 million and is expected to continue funding, our commercial and R&D operations into 2024.
Our key priorities in 2022 are to maximize the clinical and commercial potential of firewall to further strengthen our ability to create long term value.
<unk> is now the first and only FDA approved treatment, specifically indicated for advanced malignant melanoma patients and the first and only <unk> inhibitor approved for this indication.
Even though advanced malignant Tacoma is an ultra rare sarcoma with around 100 to 300, new patients per year in the U S. The launch parameters for Faro and advanced malignant Tacoma are encouraging.
We are still early in our launch it is clear that Fireeye has been well received by patients and their treating physicians alike. In six weeks since launch to the end of the first quarter, we achieved $2 3 million in net sales of fire.
We attribute this encouraging performance in part to both pent up demand and transitioning of expanded access program and <unk> clinical trial patients to commercial product and Brendan will discuss this further.
In general we are very pleased with the high level of awareness and interest among physicians favorable payer sentiment and strong patient demand.
Let me in the first quarter, we received recommendation by the FCC and guidelines highlighting file as the preferred treatment for glaucoma and very recently, we have secured a permanent J code for file which will be effective July one 2022, and should make prescribing fire or even easier for physicians.
I would like to thank Brendan and his entire commercial team for executing such a great start.
We believe this quick adoption of Fireeye is clear evidence that we have a highly differentiated product.
A difficult to treat cancer with a dire unmet need and.
And Brendan will have a lot more to say on this topic in a few moments.
On the R&D front, we are very pleased with our progress on precision one a registration directed tumor agnostic trial for natural elements and TLC, one or <unk> alterations in solid tumors.
This trial has the potential to significantly broaden the future application of Max or all of us across many different tumor types.
We enrolled our first patient in March and are steadily working to open high quality clinical sites. We are further augmenting enrollment via partnerships with Ngls providers and community oncology networks.
With these patient recruitment strategies in place, we feel confident about our intention to present preliminary data from precision one in the first half of 2023 and complete the study in 2024.
In addition to the precision one trial. Our team is also evaluating options for new single agent or combination treatments with napster all of us with.
With the goal to kick off new clinical studies in 2023.
Better annual clinical team has done a terrific job in getting the precision <unk> trial up and running.
He will give additional color on this topic shortly.
In addition in the first quarter, we have continued our company expansion in recruitment of high quality talent in all areas of the organization.
Recently established a new office in Morristown, New Jersey, a national hub in the northeast for oncology expertise and industry talent.
And so we are now officially bicoastal.
In summary, <unk> is firing on all cylinders and working to maximize the value of firearms for our shareholders.
Thank the many patients with unmet need to gain access to this important and novel drugs that efficiently target the <unk> pathway.
Our goal indeed is to establish <unk> as the leading company in precision oncology.
And then will now discuss our launch and commercial progress in greater detail Brendan.
Thank you Neal.
It is an exciting time at Eddy Bioscience, and I'm thrilled to share our results today from Eddie's first partial quarter as a commercial stage company as well as early insights regarding the launch of buy arrow input coma.
It is important to consider that by our became commercially available on February 22nd. So the results that will be shared today reflect 28 selling days over a six week time period.
We are in the early days of the launch so we will be discussing commercial trends on the call today.
Even though early we are very encouraged by the initial uptake trends are by arrow.
Underlying our success are the patients battling Tacoma, who truly need access to this important treatment option.
We are humbled to help these people as it is day that represent the most meaningful success story of this launch.
Since making product available in the market on February 22nd of this year. Our launch has been driven by three strategic imperatives.
First we need to quickly establish by arrow as a standard of care in the frontline Tacoma setting.
In order to accomplish that goal our ability to accelerate brand awareness is paramount to success.
It is too early to share meaningful brand awareness metrics. However, the breadth of ordering institutions and the early uptake across treatment centers leads us to believe that our brand awareness metrics are tracking on target.
Second our teams have been focused on managing expectations for treatment and educating health care providers to ensure a positive first clinical experience.
Based on feedback from first time Fi Arrow prescribers when volunteered by these early adopters. They have expressed a positive overall experience when using the drug.
Based on early experience. It appears that these new users can effectively initiate treatment and manage patients through multiple cycles of therapy.
And third we need to establish <unk> as a leading company in precision oncology.
Throughout the early launch we have continued to engage sarcoma key opinion leaders and have increased our visibility within the sarcoma patient advocacy community.
And throughout the ongoing launch we will continue to strengthen our partnerships and differentiate addie bioscience as a trusted industry leader in Oklahoma space.
In six weeks since launch we achieved $2 $3 million in net sales.
Right the small an ultra rare nature of Oklahoma.
We attribute this encouraging performance to several factors.
First a group of Tacoma patients treated in the expanded access program and the Amtech trial were successfully transitioned to commercial product within the first few weeks of March.
Additionally, during the intervening period between our approval on November 22nd and the launch on February 22nd Pent up patient demand had been building in anticipation of commercial product availability.
Lastly at specialty distributors were reacting to early patient volume, we observed some launch inventory build that we expect to dissipate as we reach more steady state patient demand.
Based on early feedback the reaction to the Fi Arrow clinical profile has been very positive.
In addition to the reported overall response rate duration of response data and the disease control rate from the AMPAC Registrational trial as reported in the labeling are seen as highly differentiating.
Although early market share estimates can be unreliable recent market research conducted with oncologists for adding in the U S reveal that intent to prescribe Fi arrow in the first line advanced malignant Tacoma treatment setting exceeded 70%.
Momentum for Fi Arrow was further supported by the rapid update of the NCC and guidelines early in the first quarter to reflect by arrow as the only preferred treatment option for Tacoma.
As of March 31, there were 35 accounts that ordered five era.
Because tacoma is a rare form of sarcoma, we expected to have a large representation of academic cancer centers has early adopting accounts and that has proven to be the case with approximately 75% of early orders coming from the academic treatment setting.
More specifically, we have also had a strategic focus on the top sarcoma centers of excellence in the United States, which represent approximately 60 academic medical centers.
Happy to report that through the first six weeks of launch our sales team has detailed 85% of the high potential prescribers within these accounts.
Recognition of both the unmet need in advanced malignant Tacoma and the strong Phy Arrow clinical profile has also been reflected in the sense of urgency with which payers have been adopting formal coverage policies for the product.
Having formal coverage policies in place with large payors removes barriers for treating physicians and paves the way for broad patient access.
As we have been monitoring the time to pay a review metrics for Fi Arrow. During the first six weeks of launch we see that they are exceeding the performance of other oncology product launches I'm.
I'm happy to report that as of March 31.
Payers covering 70% of commercial lives in the United States market have reviewed and adopted a formal firewall coverage policy.
I'm also pleased to report that the quality of that coverage is equally impressive with the vast majority of policies implementing a prior authorization to prescribing information position without major restriction.
Very recently, we announced that CMS also approved our application for a new permanent J code for Fi Arrow, which will become effective July one.
This is welcome news as a permanent J code streamlines reimbursement across all sites of care.
All of this rapid payer progress combined with a strong suite of patient support resources available through our patient program, adding assess has resulted in strong patient access for Fi arrow since FDA approval.
In summary, we.
We are excited about the progress we've made since the launch of Phi Arrow and we are happy that the coma patients now have access to this novel <unk> inhibitor.
Before turning it over to Loretta I would like to extend another sincere. Thank you to all my Addy Bioscience colleagues for making this early launch a tremendous success.
Now Loretta will give you an update on our clinical program.
Thank you Brandon.
I'm proud to report important progress on several funds in the last quarter.
First we have significantly strengthened our R&D group hiring high quality challenge and launching a fully operational clinical development division with all functions nearly completely staffed this has enabled us to rapidly set up trial sites and facilitate patient recruitment wildly.
Providing appropriate oversight of clinical trial conduct for the ongoing precision one tumor agnostic trial.
Secondly, we have enrolled our first patients in this trial at the Dana Farber Cancer Institute and M. D. Anderson cancer Center and have made great progress towards our goal of initiating the study and at least 20 major cancer centers in the United States by the end of this year next slide please.
Third in order to ensure a strong enrollment in the precision <unk> trial.
<unk> partnered with the leading next generation sequencing providers, including Foundation Medicine and campus. We are working closely with these and other <unk> providers, who are helping to identify patients with TST, one or T. S. T. Two alteration and also utilizing there.
Physician networks to recommend participation other appropriate patients in appreciation one trial.
<unk> please.
Importantly, we have also formed a partnership with the U S oncology to leverage its entire physician network of more than 1400 oncologists that includes more than 500 cancer treatment locations and more than 1.2 million patients participating in our clinical trials.
Annually.
This partnership will help us target community centers as well as additional academic sensors in our enrollment efforts.
Using U S. Those star program, we can rapidly activate individual sites once a patient is identified.
Otherwise for the study.
Taken together this series of focused activities should augment enrollment into the precision one trial by targeting.
Targeting both academic and community based oncology practices and by rapidly identifying appropriate patients with <unk> or <unk> alterations, who may benefit from trial participation and expediting their enrollment into the study.
We believe that these efforts will drive full patient enrollment within the next 24 months.
Slide please.
As a reminder, here is an outline of the trial design for the precision study.
The precision of the lung trial is a multicenter open label tumor agnostic pivotal study as napster elements.
Trial will evaluate approximately 120 adult and adolescent patients with solid tumors harboring pathogenic in activating alterations in <unk>, one or <unk> genes.
The trial will have two independent arms at 60 patients each to separately evaluate patients with either T SD Wan or <unk> alterations.
<unk> has received fast track designation to evaluate napster elements in this indication from the FDA.
First patient was treated in March 2022.
Last month data on the incidence of <unk> alterations were presented at the annual meeting of the American Academy of Cancer Research Conference.
This work was supported by a grant from IBM, both confirmed and expanded the initial estimates that approximately 12000 patients in the United States carry these gene alteration.
The frequency demonstrated fitness genetic alteration renders TST, one or GSC to one of the largest categories within targeted oncology occurring in two to three percentage of all solid tumor patients.
These findings give us additional confidence regarding our ability to enroll a sufficient number of patients to complete the precision one trial in a timely manner.
The reception from the oncology physician community has been encouraging.
It is unusual to have a newly approved agent that has already shown clinical proof of principle and then.
Enriched group presentations within a specific tumor type in this case advanced malignant to come on.
This is especially compelling given the well defined safety and pharmacology profiles of Napster wellness that are both now and in common practice.
Although the analysis was exploratory impressive results were obtained in patients who expressed tier one or tier two alterations, which were seen in 56% of patients with advanced malignant to come that is 14 of 25 biomarker evaluable patients indeed.
As reported in the journal of clinical oncology, a high percentage of patients with a known Inactivating. She has she won or T. S. T. Two alteration that is nine of 14 or 64%.
<unk> Registrational study of patients with advanced malignant Tacoma achieved a partial response or a complete response with impressive durability. We continue to carefully evaluate other potential opportunities for either single agent or combination therapies with napster elements.
To expand use in other patient populations. We believe there are very interesting opportunities across different indications and we have been inspired by the many suggestions we had been receiving from the community.
I'll now turn it over to Scott for a financial update.
Thanks, Loretta and good morning.
I'll now summarize financial results for the quarter ended March 31 2022.
A more detailed discussion of results will be provided in our 10-Q to be filed later today.
We ended the quarter with cash and cash equivalents of $129 $8 million.
Based on our current plans, we expect cash and cash equivalents to fund operations into 2024.
Total revenue for the quarter was $2 3 million consisting entirely of net product sales of <unk>. Following the February 22nd launch.
As Brendan mentioned this number reflects <unk> trial, and EAP patients who transition to commercial product during the quarter.
Pent up patient demand related to the timing between approval and launch.
And initial inventory build at the specialty distributors.
Cost of product sales amounted to 0.2 million for the quarter.
<unk>, primarily royalties on <unk> sales.
Cost of sales was favorably impacted by <unk> inventory costs incurred prior to FDA approval, which were Expensed as research and development in the period incurred.
Research and development expenses for the quarter were $6 8 million compared to $3 6 million in the prior year quarter.
This increase is due primarily to costs related to the initiation of the precision <unk> trial and the build out of the R&D organization.
Selling general and administrative expenses increased to $9 1 million in the quarter from <unk> 6 million in the prior year quarter.
This substantial increase is mainly the result of expenses related to the buildout of our commercial operations and infrastructure and increased marketing expenses to prepare for the commercial launch of <unk>.
The resulting net loss for the quarter was $13 9 million compared to $5 5 million for the prior year quarter.
Thank you and I'll now hand, the call back to Neil.
Thank you Scott in summary, we are very pleased with the early acceptance of Fireeye by the physician and patient communities and we remain encouraged by the trends seem so far.
Intently focused on enrollment and precision one and look forward to maximizing the application of natural almost could treat other cancer types.
Before we open the call for Q&A I'd like to take a moment and thank the entire team here at <unk>.
Impressive focus hard work and execution over this past quarter.
Looking forward I'm confident we are well positioned to continue to execute successfully.
Both on our <unk> commercial launch building on the momentum of our first partial quarter that we reported today and on the R&D side, our continued execution of our precision one tumor agnostic trial.
With that operator, I'd like to open the call for questions.
Thank you we will now conduct a question and answer session. If you will.
Like to ask a question. Please press star one on your telephone keypad.
<unk> will indicate your line is in the question queue you.
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One moment, while we poll for our first question.
Yeah.
Our first question comes from Barbara Speaker with Cowen. Please proceed.
Good morning, and congratulations on the progress.
Hi can you hear me guys.
Yes, as far as I can here are fantastic. Yeah. So my first question is you mentioned that that part of the revenue was inventory build can you comment approximately how much do you have an estimate or an estimate of end user demand.
Ed.
So hi, this is Neil.
Brendan would you like to answer that question. Please.
Yeah, Yeah, I can I can answer that thanks, Bob.
Boy, it's hard to comment on and quantify it what I would say is that.
Hum.
Usually obviously, it's expected at an oncology launch that you'd have some built up inventory I think here.
You are probably a couple of weeks on hand above what we would expect and I think that's a little bit of you know.
Specialty distributors reacting to higher than anticipated volume early on right. So I think that's part of it is hard to quantify though because there's multiple levels of inventory that we don't see for example, a lot of the ordering as you heard in the prepared remarks. It was done by academic Institute.
<unk> many of which.
Our carrying some inventory as well in addition to the specialty distributors. So it just didn't.
Introduces another.
Level of complexity in trying to quantify it I would say we're pretty excited about.
What we're seeing.
Travel aiding us underlying patient demand, but I will say also the pent up demand in the situation, where we launched in.
<unk> received FDA approval in November and ultimately launch in February I think patients. We're building at that time as well and that certainly also contributed to I think.
An exciting start here.
Great and just how long do you anticipate these patients.
On treatment.
Again hard to say Boris I think it's encouraging what we see as far as reorder patterns right, but we don't have patient level data to track individual patients, but I think when we see that accounts that ordered are reordering. It certainly encouraging but that's a loose kind of.
Metric for.
Duration at this point, which is going to be very difficult not not only in this early part but for the next.
The months ahead due to really determined but I think it's early but we're encouraged by what we say that's the best way right and my last question for precision. One you mentioned the first interim is going to be in the first half of next year can you comment on what we should be expecting in terms of minimum rotations or any other expectations for that interim update.
Yeah, Hi, Boris this is Neil.
Can take that one.
So as we've said before.
This trial is <unk>.
Just begun enrolling.
And so the.
Visibility into the enrollment rate et cetera, we will of course come but that will come later in the year as many more centers get online so in terms of.
The exact sort of nature of the updates that we would provide.
In the first half.
It's hard to predict exactly the number of patients but that said.
We expect.
A meaningful number of patients so that investors and analysts like yourself.
You can look at the data and <unk>.
Feel confident about the future.
Of the drug.
In terms of the.
The other types of analysis or information that we will provide we would probably give some color on the different tumor types that have been enrolled in the study.
And.
And give some information about the outcomes in these patients at that time, but again.
A bit early right now to predict exactly.
The nature of the outcome. We should also keep in mind that this is a registration trial.
And so there are some limitations thereof.
Secondly, and importantly, we are in the unusual situation that we have an approved drug that is being marketed for advanced to coma.
But we have to be very careful of off label.
Type promotion and how any data we put out there can be construed so with those limitations. The goal of course is to give investors.
You look at what we're seeing in the trial early on.
Alright, Thank you very much for taking my questions and congratulations on the progress.
Our next question comes from a wound to mirror with Ladenburg Thalmann. Please proceed.
Good morning, congratulations on the progress and thanks for taking my questions I have two questions on the commercial side.
Then well go into the precision one on the commercial side could you. Please comment on the number of prescribers and also payers coverage, considering Medicare versus commercial Payors effect.
Yes.
Sure.
Oh Im sorry, okay.
Yeah.
Go ahead, Brendan payout, yes, sorry.
Yes, so on the we don't have visibility on the prescribers as you know with an IV therapy.
Once the vials shipped from the distributors to the institutions, we lose visibility.
Many levels, including the patient level.
So we don't have patient level or prescriber level type of information. The best we have is institution level in which we've reported there that in the first six weeks 35 institutions have ordered and then your second question on the payer was the mix between commercial and Medicare.
That's correct, yes, Brendan yes.
Yes, so we don't have a specific mix of what it is on the snapshot the anticipated payer mix is around 50% to 60% commercial payer and maybe in the 30% range on Medicare keep in mind that that's driven by the nature of Tacoma, where it's more prevalent in females, who are under the age of.
65, so the the payer mix makes sense, but as far as commenting on the mix as it stood in the six weeks, it's very difficult to do I wouldn't say that we've been very encouraged by the response, we've had from payers as I mentioned in the prepared remarks with how quickly theyre putting coverage policies in place, but also their their policies.
Without restrictions and that's very encouraging so on the payer front it looks very positive as well.
Thanks for that information Brendan and my other question is on the precision launch what is the how many sites are currently open and how how many additional price are we expecting to open up this year.
Yes. Thanks. So this is Neil.
<unk> would you like to answer that question. Please.
I'm sure I'm currently we have six sites open here in the United States and and you can.
You take a look and see who they are on the plane trials Dot Gov website, we update that periodically.
Our goal is to open at least 20 major cancer centers here in the United States by the end of the year and of course that will be augmented by our partnership with U S oncology etcetera.
So that is our goal and we're on target and we have every intention of achieving that.
Thank you if I may I have one last question I guess.
So our presentation the combination of Jesse she is well disclose that <unk> three inhibition inhibitor combination I'm just curious if you could elaborate more on that.
Typically <unk> since they are more specific to U S. T. L cancer. It's just curious on your comment.
Yes. So this is Neil I can take that one again.
And in the ACR presentation. The key information that we presented was.
The incidence of Trc, one in PSC to rule.
Element alterations.
In terms of the number of patients on an annual basis in the U S, which was about 12000.
It was also interesting to note that we looked at other type of mutations that.
Ken Cook or.
Overall, they were a small percent of the total TSA <unk> population, but the suggestion there is that.
Given the some co mutations in the future as we analyze other strategies for combination therapies.
We will be looking at.
Strategies like that so for example, which combination drugs can we use along with our drug we haven't.
Finalize that yet in that process of evaluation is ongoing is theres. Many types of very interesting combinations that we can get into but.
Does that look in that presentation of data certainly helps us.
In finding populations that may be highly relevant.
In the future.
Very helpful. Thank you very much I appreciate you taking the time time for my questions.
Okay.
Okay.
Yeah.
Yeah.
Our next question comes from Joe, Kansas Zero with Piper Sandler. Please proceed.
Hey, guys. Thanks for taking my questions and congrats on the progress here, maybe one first on the fire launch wondering if maybe you could help us think about the rest of the year commercially and speak to whether there are still any EAP patients left that needs to make the transition as well as how we should think about the pace of new patient starts moving forward.
Following sort of this pent up demand that you experienced.
Yes, Thanks, Joe Brent.
Brendan would you like to take that please.
Yep.
Appreciate the question. It's really it's early at this point as you know and I don't necessarily want to make any kind of predictions because there's multiple levels of <unk>.
Complexity here is as you can.
I appreciate.
I think.
I think we're off to a good start I think the.
Some of that the new patients that have come over early on we expect to have some duration on that so that will obviously play out for the remainder of the year as well as new patient demand coming in.
As far as the EAP patients, we don't have 100% visibility, but we feel pretty confident that the majority of those patients were transitioned successfully by the.
By the centers and we wouldn't expect any necessarily additional from either impact or EAP coming in.
Same with the pent up demand.
That were describing I think that was patient building from November to February and they were they were waiting for the drug to be available in the market and got on pretty quickly again. That's those are estimates it's a little early to comment on what it looks like for the rest of the year as I said, we're encouraged by what we're seeing but I don't think we're at a steady state.
Underlying demand and able to predict what happens in Tacoma, given the ultra rare nature of the disease. So hope that helps.
Yeah No no that's.
Or maybe another follow up here I think you guys had mentioned that you were going through an EMA scientific advice process.
Just wondering sort of where you guys are there and what are your current expectations are around a potential.
MAA filing.
Yes, Joe this is Neil I can take that one so yes, we are in that process.
And as we've mentioned before we expect.
To receive that scientific advice.
Later in the second half probably later in the fall.
Just based on timing and back.
Backup of the EAA.
They've indicated several times that there.
We're very backed up.
In terms of the process.
Hard to predict exactly when but.
We expect that later in the fall.
Would have gotten that advice so we can.
Update following that.
Okay got it and then if I could maybe squeeze one in on precision one wondering if you'd just have any comments on the early experience screening patients for <unk>, one and two and maybe your early ability to confidently call. It the alteration is pathogenic or not.
Yeah.
Yes, I'll comment and then pass it onto Loretta.
In terms of screening.
I'm not sure that we can provide any information at this point since the process is very early.
But.
The patients go through the standard NGF screen and then we have a central reviewer.
Loretta would you like to add anything to that please.
No I'm I'm really not clear on.
What the question is but it has not been a problem GNC one and she has situ are routinely included in virtually all Ngls reports.
So it's not hard to find them the issue of whether or not.
Our Inactivating I think may be the question you're asking.
The way we handle that is it that we actually have provided sort of the.
Chi Chi to all of our participating institutions. So that it enables them to translate the Ngls report on their own so.
By the time, we get the Ngls.
Report with the patient we're pretty certain that they are in activating and it then has a less than 24 hour turnaround by our central reviewer.
And we can confirm whether or not.
Whether or not that TFC abnormality is indeed true.
Hedging or inactivating so it.
We're pretty fine tuned machine at this point, we can turn around very quickly. So that at this point does not appear like it's going to be any kind of obstacle for us.
Okay great.
What I was sort of asking about so that's that's helpful. Okay. Thank you for taking my question.
Once again to ask a question Thats Star one on your telephone keypad. Our next question comes from Roger song with Jefferies. Please proceed.
Okay great.
My wife before they even as your lunch.
A couple of questions on that.
The first question please.
What is the current reimbursement process before the J code and the Hall. This J code will facilitate the reimbursement and.
Sequentially, how do you expect that the girl student that evolved over time, what is that kind of a steady state kind of gross to net you imagine.
Okay.
Yes, hi.
Hi, Roger this is Neal thanks for joining.
You were a little soft there. So if you don't mind just repeating the question again, so we make sure we heard it clearly a little bit louder. Thank you.
Yes, sorry about my voice.
So can you hear me now.
Yes, I think that's better. Thank you okay. Great. So the question is what is the current reimbursement process by Hollywood, the J code to facilitate our future reimbursement and specifically.
How do you expect that the gross to net.
<unk> over time, what is the steady state gross to net will look like.
Kind of a model.
Okay. Thanks, we could hear that well.
Brendan would you like to take that please.
Yeah.
Yes, Roger how are you.
I think on the J code it really just streamline streamlines the process right. So currently a lot of payers have come on with.
As I mentioned positive policies with a prior authorization to label, which is not not that restrictive I think what.
A lot of this of the billing is done on the Medicare side through a temporary code a miscellaneous J code and that leaves a lot of prescribers, especially if you're in a community setting uneasy about getting reimbursement for the drug and sometimes also sometimes things get held up right because it may get confused mess and it creates kind.
Burden for the prescribers in the patients as far as their time to get on therapy. So what the what the permanent J code does is assigned a specific code for Fi Arrow. So you don't have any of that.
Perceived risk and it's just much more streamlined because it has it.
Specific code in place, there's obviously a process to apply for that and that's that we've executed on very well and we're getting the J code at the earliest possible time, but this is all normal Roger for launch execution in oncology with a you know an IV therapy and I think we've executed on it very well I don't think.
We've seen any type of as far as the current process with the miscellaneous J code, we haven't seen any obstacles or heard any pushback.
The field now part of that May be related to you know as I mentioned the majority of our youth early on which is expected as in the academic medical centers and they have.
Lot more resources to make.
At work the process the reimbursement process seamlessly even in the early days of launch and then Neil did you want me to comment on the gross to net question as well.
Yes.
Go ahead, and if Scott needs to add.
Certainly do that.
Yes, I think we estimate now Roger but I think.
Somewhere estimate within the 15% to 20% range for G. T. N is probably a safe estimate at this point and hopefully as time goes on we'll get better information and see what that looks like but I think right now between 15, and 20% is probably a safe estimate Scott I don't know if you have anything else to add.
Yeah, no nothing really to add other than to say, it's hard to say, how it will evolve Roger obviously dependent on how the.
On the commercial mix.
Shakes out over time, but yes, I agree with everything Brennan said on where ultimately we think we'll probably end up.
Okay great. Thank.
Thank you for the color, maybe just squeeze one for <unk>.
Precision.
Yes, I think you provided some very good color Rob.
We will tell Rob maybe just ask it specifically.
Do you have a estimate timeline from the patient.
Signed up a consent and all the way to you cant say definitively.
That patients get diagnosed with GSE or whether that's you.
Activating mutation what is the overall pipeline look like I understand the way you get if you ask you Paul you can get the final local within 24 hours, but just curious about that the whole process timeline look like thank you.
Yes, Thanks Roger.
Loretta would you like to just comment on the question. What are you clear on the question first of all I think the question was.
Timeline from consent.
Essentially to the kinds of patients.
Officially gets on this study you will see those drugs.
Well by the time, you get concerned that patient is really quite far along a they've been identified as having the abnormality.
They have qualified for all of the inclusion exclusion criteria. So for the most part.
I would say from the time, we consented patients it's relatively short.
I would say two to three weeks before the patient actually goes on study.
But you know.
These being patients who are seriously ill.
You just never know what's going to happen.
So with COVID-19 around sometimes they they will get a COVID-19 infection and that puts it back another 10 days.
Variable highly variable funding in general I would say two to three four weeks.
About about in that range.
If that's helpful, but that's what we're seeing so far.
Got it yeah, yeah. It's helpful. Okay. So that's a that's a follow up thank you.
Thank you Roger welcome.
Thank you at this time I would like to turn the call back over to the Doctor and they'll decide for closing comments.
Thank you.
On behalf of the entire team at Audi I would really like to thank the investors and analysts for joining the call today.
We certainly look forward to interacting with you in the future and then providing any necessary updates as we continue to progress and build value in the company.
And thanks, very much again for joining and we can close the call now.
Thank you. This does concludes today's teleconference. You may disconnect. Your lines at this time and thank you for your participation and have a great day.
Okay.