Q2 2019 Earnings Call
At this time all participants are in a listen only mode. Later, we will conduct a question and answer session and instructions will follow at that time.
If you require operator assistance during the program. Please press Star then zero on your Touchtone telephone.
I would now like to discuss this conference call Ms., Melissa Downs head of Investor Relations you may begin.
Thank you operator on behalf of Progenics management team. Thank you for joining our conference call to review our second quarter 2019 financial result, and provide a business. After joining the call today are Mark Baker, Chief Executive Officer, Dr., I should die Chief Medical Officer, Brent I'm, our senior Vice President commercial and Pat Fabio Executive Vice President and Chief Financial Officer before we begin I remind you that remarks made on this call that are not historical in nature may before looking statements and are subject to a number of risks and uncertainties.
Actual results may differ materially.
Such remarks May include but are not limited to those involving regulatory actions clinical development and other matters related to our prostate cancer pipeline that drop relistor and our other product candidates.
Our business and commercialization strategies and expectations of future growth revenues and assessments of our competitive position.
Please see our most recent forms 10- Q1 0-K and other filings with the U.S. Securities and Exchange Commission for additional information on the risks that could cause our actual results to differ as a reminder, statements. We make today are as of August nine or me.
I'll now turn the call over to Chief Executive Officer, Mark Baker month.
Thank you Melissa and good morning to everybody joining us today.
We reported meaningful progress across our entire portfolio of targeted radiopharmaceuticals designed to find sites some follow counts.
Setting the stage for free for future growth.
A key focus for us this past year has been the launch of as Andrew.
Price will provide a commercial update momentarily.
But I want to begin today by highlighting the recent new technology add on payment and channel ruling.
From the centers for Medicare and Medicaid services or CMS.
This new action by CMS amounts support for the significance of a center as a new clinically relevant product offering substantial benefits for C O and para patients. The untapped provides an important increase in reimbursement to hospitals, when treating inpatient Medicare patients with et cetera.
We are encouraged by the progress we are making and believe that we're laying the groundwork to support the long term commercial sense successive et cetera.
In parallel to our as enter launch we also achieved key milestones for our portfolio of P., assuming targeted pipeline of diagnostics therapeutics and technologies for prostate cancer.
Most recently, we completed enrollment well ahead of schedule for our phase three condo or study of our P., while imaging agent for prostate cancer. They also know star first patient in our phase two trial of 10 90 fives.
Ashley will discuss our clinical programs and regulatory updates in further detail a little later on.
I'll now turn the call over to brace for the Azedra commercial Humpty price.
Thanks, Mark as Mark mentioned, we recorded our first sales of Azedra in the second quarter and we are building on that milestone as we advanced the commercialization of Azedra.
We have 32 treatment requests for commercial focus is on converting these request the treated patients.
Last week CMS approved a new technology add on payment or intent for azedra when administered in the hospital inpatient setting for Medicare beneficiaries.
The intent determination by CMS validates the significance of Azedra, the new clinically relevant product for field inherent patients.
Plays a vital role in providing supplemental reimbursement for the in patient administration of Azedra.
Fewer than 30% of the products I have ever been proposed have been granted this special add on payment for the inpatient hospital setting.
The intact will cover the lesser of 65% of the average cost of azedra or 65% of the costs in excess of the Medicare severity diagnosis related groups or MSD RG payment for a case.
As a result, the maximum new technology add on payment for case involving a therapeutic doses of Azedra is $98150.
We currently have 13 centers throughout the country that are activated for patient treatment with our patient support services programs available to support out of pocket needs, including travel to these centers. We can accommodate the patients who are in need of therapy and are continuing to work with centers across the country to broaden the availability of azedra.
As we've worked through the Onboarding process with centers of excellence, we are concentrating on the broader referral community to familiarize endocrinologist and other positions that may seem to be on their patients with the potential benefits of Azedra. We're doing this through non personal efforts such as traditional print media as well as social media and through the direct efforts of our sales force.
Our market access team is working to ensure proper support is available to our activated centers any coding and billing systems are pass through C code from CMS was approved earlier this year and we anticipate that our permanent codes will be awarded in November and implemented in January 2020.
We're also pleased that commercial payers are supporting reimbursement for Azedra and all plans that it wouldnt coverage policies are covering flavor.
In July we announced the hiring a few jones in the newly created role of Vice President commercial you has over 30 years of global experience, leading commercial strategy and operations in the pharmaceutical industry with deep experience in Radiopharmaceuticals and oncology, who joined our team after two decades at Novartis and its subsidiaries, where we serve in multiple commercial leadership positions. Most recently as interim general manager and Vice President of marketing and sales for the company subsidiary Advanced accelerator applications. We are very excited to have you join our team at this important time for Progenics as we are executing on our ongoing commercialization of Azedra started to prepare for the launch of few while on the U.S. and advancing to 95.
I will now turn the call over to option for an update on clinical developments caution. Thank you Brian are growing medical affairs team is actively educating the physician.
The next leader community.
New building awareness of et cetera.
For example, the recent ASCO presentation was particularly well attended with the steel and Teradata, demonstrating a five year long term survival rate of 38.3% and a median survival time of 41.1 months impressive outcomes. In this patient population with unresectable locally advanced or metastatic feel or parents, who will require systemic anticancer therapies.
We're moving forward with our lifecycle management plans and have reached alignment with the FDA to conduct a basket study that will evaluate that that growth in patients with neuroendocrine tumors that are in mind, BG Abbott, including gastro and pro pancreatic neuroendocrine tumors or just mix and other mix.
We plan to use the dosing regimen that potentially enables outpatient administration.
Key opinion leaders have been supportive of this plan.
Especially due to the lack of treatments available for rare type of tumor.
The Boston is expected to initiate by the end of the year and will enroll approximately 150 patients at sites in the us and Canada.
Now turning to P., while we're very pleased with the recently completed enrollment of our phase three candour study of P., while for the detection of prostate cancer, well ahead of our previous fourth quarter guidance.
Increased interest in the program translated into rapid enrollment of 208 patients with biochemical recurrence of prostate cancer.
Topline data from this study is expected by the end of the year.
And if positive will serve as the basis for an India for the program, which we expect to file by July 2020.
Recent presentations from multiple investigator sponsored studies have increased our confidence in the potential utility of this novel imaging agent.
Collectively the M- emerging data profile highlights the diagnostic potential p., while to detect locally advanced prostate cancer biochemically recurrent prostate cancer.
Metastatic disease.
And importantly.
Alter physician prepayment decision, making.
These studies have demonstrated that p., while provided early detection of disease.
Including in men with very low PSC levels.
Additional data show that pure white ale identified sites of recurrent disease and change clinical management in patients with negative conventional imaging.
Overall, the data suggest that few while could be a one stop shop for the evaluation of patients with biochemically recurrent prostate cancer.
These independent studies taken together with our Osprey data are encouraging we have great confidence in the program as we head into our car nor readout at year end.
Turning to our ex US development efforts, our European P., while partner Curian is in dialogue with the European Medicines agency to discuss the regulatory path forward for P., while in Europe .
And we look forward to providing updates when available.
Let me close with 10 95 radiotherapy.
Which has a mechanism of action that may overcome resistance develop to BNP androgens.
In June we dose the first patient in our multi center randomized open label controlled phase two clinical study evaluating the efficacy and safety of 10 95 in combination with Enzalutamide compared to Enzalutamide alone in patients with metastatic castration resistant prostate cancer.
Or PSR may avid.
Chemotherapy naive and progress on abiraterone.
Give me a bit study is determined utilizing PV while.
We plan to enroll approximately 120 patients in the study in a two to one randomization. The primary endpoint is PSC response rate.
Secondary endpoints will evaluate radiographic response progression free survival and overall survival patients will be followed for one year. After their first treatment for all efficacy endpoints.
Survival and safety data will be collected for an additional year.
Based on the early data from this open label study and dialogue with FDA, we plan to evaluate initiating a pivotal trial of 10 95 in 2020 .
We are proud of our recent clinical advancements and look forward to moving our pipeline into late stage development during the second half of the year.
Let me now turn the call over to Pat for a review of our financials Pat.
Thanks, Alicia you can review details of our financials in the press release, we issued this morning.
And in the 10-Q that we will file later today.
Second quarter revenue totaled $10 million up from $3.9 million in the second quarter of 2018, primarily due to the achievement of a $2 million milestone.
Under the Bayer agreement for the dosing the first patient in a phase one trial of PS M- TTC.
And to $4 million upfront payment from Fuji film.
Under the ABS I transfer agreement.
Second quarter Relistor worldwide sales were $24 million as reported by our partner fell short.
Is that your sales were $270000 and reflect therapeutic dosing that began in June .
Research and development expenses increased by $3.7 million compared to the corresponding prior year period, resulting primarily from higher clinical contract manufacturing costs for clinical trial materials for 10 95 in Q while.
And higher costs associated with the transition for the Azedra manufacturing site.
An additional production capacity for iodine based products.
Second quarter, selling general and administrative expenses increased by $7 million compared to the corresponding.
Prior year period, primarily attributable to an increase in legal and advisory fees associated with the contested election at our 2019 annual meeting of shareholders of $5.5 million.
And PS in May 617 litigation costs of $1 million.
We also recorded noncash adjustments of 900000.
In the second quarter 2019 related to changes in the fair value estimate of the contingent consideration liability.
For the three months ended June 32019, we recognize interest expense of $1.1 million.
Related to the Relistor royalty back to norm.
Our net loss for the second quarter was $19.7 million or 23 cents per diluted share.
Compared to a net loss of $15.2 million or 20 cents per diluted share.
In the corresponding 2018 period.
In terms of our cash position, we ended the quarter with cash and cash equivalents of $84.8 million.
Reflecting a decrease of $24.8 million for the quarter, primarily reflecting cash used for operating expenses.
And now I will turn the call back over to Mark to conclude with a review of our corporate developments.
Thanks Pat.
In parallel with our clinical progress we've continued to form in advance important partnerships, which we believe will help maximize the value of our assets.
We continue to leverage partnerships with global pharmaceutical companies to enable the further extension of our PS may targeted pipeline and AI technologies worldwide. This includes our license agreement with ROE top for the rights to develop and commercialize fourteenfour, our pmeight targeted small molecule spec siti imaging agent in Europe .
Based in Germany roadmap is a leading radio pharmaceutical company focused on diagnostics and therapeutics as well as a strong expertise and the production of technetium kits such as 14 Ofour.
Per the agreement Progenics is eligible for double digit tiered royalties based on future sales of 14 or four in Europe .
Roto plans to refine their clinical development plans based on guidance from leading Kale wells before meeting with European regulators and beginning a clinical trial next year.
Separately, we for furthered our relationship with Fuji film.
With a transfer agreement soon for the rights for our SB eight B ESI product in Japan for use under the name Bona Nabil.
Bona Novvi has been licensed to Fuji film for use in Japan since 2011.
Our ABS side has the potential to improve physician treatment decisions for prostate cancer by providing a fast and reliable alternative to manual interpretation of bone scan images. These validating AI collaborations further highlight the potential of these technologies to improve the patient experience and streamline physician treatment decisions in June we presented data at Essent mm Eni in which we evaluated the diagnostic performance therapy, assuming AI using spec Cts scans from the company's phase three study of 14 for.
Independent readers using our PSS.
Demonstrated a statistically significant improvement in accuracy speed and reproducibility over readers without FPSO may AI, a conclusion that again shows the clinical potential of these technologies.
We look forward to presenting further AI data throughout the year as we continue to advance the development of these diverse cutting edge technologies in support of our Pmeight AI development efforts. We recently received five 10-K clearance from the FDA for the cloud based version of ABS side.
This is an important step in the development of Ts EMEA for use with POI al.
With this five 10-K in place further product developments based on this core technology will benefit from a more rapid streamlined approval process.
Finally, before we open the call to questions I want to provide an update on the PSC may 617 litigation.
As a reminder, we are asserting ownership rights to intellectual property for PS. Some a 617 earlier this week the district court of Manheim, and Germany held the first oral hearing in the case the court considered procedural matters and granted the parties the right to make further submissions.
We recognize that the launch of Azedra has been challenging.
That said, we believe that we are seeing signs of progress evidenced by our first recorded sales continued increase in treatment request strong interest from cave wells and our recent and tap ruling from CMS.
Our passionate team is motivated by our mission to develop diagnostics therapeutics and technologies to find fight and follow cancer.
As we continue to advance our pipeline into late stage development and are nearing regulatory filings, we remain focused on delivering value for shareholders I want to reiterate that we value the views of our shareholders and are open to any opportunities that may advance our common goal of enhancing shareholder value.
We believe that Progenics is well positioned for our next phase of growth and look forward to achieving our milestones for our pipeline in operations in the second half of 2019 and beyond.
With that I'll open the call for questions on our second quarter financial results and commercial and corporate progress operator.
Ladies and gentlemen, this you have a question or comment at this time. Please press. The Star then the one key on your Touchtone telephone. If your question has been answered the question yourself from the queue. Please press the pound key.
Our first question comes from Martin also with credit Suisse.
Hi, Tim This is cary from.
Credit Suisse on from Marty just had a quick question.
Congrats on the third through patient request, if you can elaborate a little bit on is that an aggregation of since the commercialization of azedra.
Or is that within this past quarter. Additionally.
Would you be able to give any type of guidance in terms of.
The scheduling process for those two to new patients maybe a pine on the gating steps to giving them scheduled before the end of the year.
That'd be very helpful for us thank you.
Thanks, Bryce do you want to address that question or yes, just to be clear the 32, our cumulative since since approval.
And in terms of.
The status of those right they range from.
Being scheduled for dosimetry.
And all the way to still working through benefit verification with the centers.
And with with payers.
Also.
We're in the process to scheduling second doses for some of those patients as well we've as Mark said.
Those two therapeutic doses in the second quarter.
We continue to schedule and dose patients.
And.
The gating process is as we've always said right. We did identify the patients we have to do to benefit verification working closely with the centers throughout that process.
Patient scheduling is very interesting we've seen it range from.
Dance disease, moving so rapidly that unfortunately patients don't make it to therapy too.
In other situations patients.
Fortunately being able to schedule the administration such that it fits comfortably into their lives. So it's it's.
It's a wide range that can occur on an individual basis, but one of our focuses.
As a commercial team is too.
Make sure.
Centers can continue to move more rapidly through the identification scheduling and administration process for each patient.
And like I said, we we work very closely with these centers to do that.
Helping them with their reimbursement questions.
With.
The necessary process often of transporting these patients and we've got programs in place to do that so we continue to make progress on that front.
So the 32 does not include patients that have already been treated once you are treated you are no longer a treatment request.
And in some cases, the patients didnt seem to be.
Appropriate medically for the treatment and so the 32 doesn't include those patients.
If you are no longer under consideration, obviously, you're not in that list right. Yet those are 32 active cases that we are working through with the centers to move to treatment.
Thank you for the additional color.
Your next question comes from Chad Messer with Needham and company.
Great. Thanks, Good morning, and thanks for taking my questions.
A couple from me.
First starting with the NPAT payment.
Can you help me understand exactly what that means for you guys and per you're getting.
Paid for per treatment, so thats a payment to the hospital, but doesn't necessarily have anything to do with with with what you guys are getting reimbursed I I'm actually kind of naive on that you could help me understand.
Yeah No Chad.
Thanks for the question. It is the case that for all patients before Zadra, who were treated in patient, it's actually the hospital right that needs to seek out reimbursement and get paid.
That's a separate process from the hospital paying Progenics now that said were very concerned obviously would that process, because we want our customers to get quality reimbursement.
You, probably recall, though because we have a fairly young patient population here with the average age of diagnosis being in the early forties. The majority of patients are commercially.
Insured I'll get to in a moment, how this impacts those patients, but primarily this impacts the other portion of patients not insignificant.
30% to 40% better.
Covered through Medicare right now I will say when we talk to centers.
Prior to.
During post launch they necessarily viewed those two dichotomy patient populations is very different from a reimbursement standpoint commercial payers have always said and they are coming through with quality reimbursement because of the high unmet need and the small patient population.
With CMS reimbursement mechanism, which is driven by what we call the Medicare severity diagnosis related group, which as BMS DRG is is a.
Relatively small fixed payment for the in hospital administration of the products, depending on which CMS DRG a hospital chooses it ranges from anywhere from $5000 $20000. So.
Hospitals being pragmatic right have to look at that and realize that we're on the average dose of azedra costing around $150000. There is a large gap right and their ability to get reimbursed for that so this announcement for those patients.
Who are eligible for inpatient Medicare.
Reimbursement.
Is significant because it will cover.
65% above the gap between the cost of Azedra and whichever Amex DRG the hospital applies so and.
We feel that again.
It doesn't directly impact payment to progenics, but the hospitals are going to be less reluctant to use this product in the Medicare population because the quality of their reimbursement just went up significantly.
So am I correct.
Yes, we've thought of this as a sort of a 70 30 split between commercial and Medicare Medicaid. So the significance of this news is that we now see a strong way for.
Hospitals to get reimbursed on that 30%.
And the 70% as price says is something that has has been looking good since the launch of the drug.
And so for a center of excellence that wants to tree, both commercial patients and Medicare patients now there has been a substantial leg up it's not 100%, but its 65% other cost and so we think that will have a very positive effect on you know.
As Andrew at use in in those institutions.
All right. Thanks, Thanks very helpful. Thats, what's good for your customers to the hospitals is good for you indirectly or prospects yes.
Alright.
Maybe moving on to the PSC may therapeutics with the bare finally going into the clinic you now have.
Q pmeight targeted agents.
In development.
Given your focus on yes, it may I imagine Thats a good thing for you guys, but can you just help us understand the difference between Lorient antibody and day iodine labeled small molecule in terms of.
Their properties of characteristics and how they may benefit patients differently.
Yes, so you've touched obviously on the two important characteristics of a radiopharmaceutical, which is what's the targeting moiety.
And what's the radio isotope.
And so in prostate cancer, you, we've seen the use of small molecules and.
Antibodies.
Outlet my personal view is that when you're talking about imaging agents antibodies don't make sense because of their uptake and clearance.
No not really working in a diagnostic setting.
So we have focused our.
Imaging agents on small molecules as you know.
But with a therapeutic the use of an antibody does present, some appealing a benefits.
And that is what bear is pursuing using our antibody in that climber Ashish collaboration pmeight targeting and thoracic.
Sorry, I am as an alpha emitter, whereas with our 10 95 drug.
A small molecule, we're using iodine 131.
What's the difference in the isotope well I think many had been intrigued by the Alpha emitters.
Because they offer the potential benefit.
In terms of the energy they bring to the killing of the tumor cells.
And the primary concern there has been the side effect profile with Alpha emitters seen some significant side effects, particularly around the salary glance, where there is some people some expression and the salivary gland function.
So I think there and we are making an intriguing bet, they're using antibodies. This is targeting moiety.
And using the alpha mentors because the targeting moiety may help avoid the severe side effects and and allow the alpha radiation to go right to the tumor so.
That experiment now being run and bear.
In phase, one and we'll see if that strategic thinking pays off with the small molecules are drug 10, 95, and then the driver now owned by Novartis 617, where were were claiming.
Ownership rights.
Yes, our using small molecules. So I think the targeting the way these are very similar.
But they are the differences between iodine and nutrition.
For us the advantages of iodine is it's very well known side effect profile well known as good availability as an isotope plan and so which isotope will prove best in the long run on T., shim or iodine well those experience being run right now.
And I I definitely think theres the potential to support in a commercial marketplace.
Those different two different isotopes.
That's it onto your question Pat Yes, no I appreciate that that was very helpful.
And then I have maybe a quick one on the VA collaboration.
Sorta, how thats working operationally is this more of a you're setting up your software with the researchers.
Obviously they have.
I imagine a large number of prostate cancer patients or is this more VA.
Clinical data is being looked at by Progenics tied to it or is that kind of a collaboration of both and what should we expect out of this collaboration.
In terms of benefit for Progenics.
Yeah. Thanks for that question.
And it's a.
It's both.
And.
From the VA perspective, you know this is bringing cutting edge technology to the treatment of our veterans.
And in the VA system prostate cancer courses.
Cancer of major concern since that population is still overwhelmingly male.
And so the.
West L.A. VA group has really been a leader there and.
I also want to recognize the great role that the prostate cancer Foundation has played in building these relationships. So.
Goal number one is.
How do we how do we get cutting edge care to our veterans and.
This is a leading example of it.
What's the benefit to Progenics, while first that that we're able to help these patients and and second that we begin to generate very deep data.
And that's what our AI algorithms depend on you know extensive deep data.
If we were to follow patients in a clinical trial.
For the purposes of generating this kind of data it would be very expensive.
And.
We'd be looking at.
Very significant CR, all costs, but with the VA system, we're able to follow the men simply by looking at their health care Records.
And so.
It's a lower cost way for us to generate.
In a really high quality data.
That will train our algorithms over time, so that aspect of it is the thing that we value most from Progenics perspective.
And you know our AI is moving ahead to at all.
Wonderful clip as you heard earlier, we got five 10-K clearance.
Very quickly from FDA on our cloud based ABS side and and this year. Our AI is covering its costs our revenue from a on our covering the costs that we are spending on it. So that's happened much more quickly.
And I think thats the advantage.
Chad that we're out in front.
Definitely ahead of anyone in prostate cancer in this type of work.
And then maybe one more quick one on on a mixture.
Expanded relationship with Fuji.
If I remember you know growth goes way back we havent heard very much.
News from that.
Even look for going on for some time, but I have to have to take that that could you. Please.
They are stepping up with more money and want access to.
To the expanded capabilities you have can you just talk about what he's been doing and what they what they hope to do and how they hope to benefit from it.
Yes.
It's been a great relationship.
Going back with them.
They provide.
This software too.
Doctors in Japan.
And the doctors that are using it in their everyday practice, so we see in Japan the adoption of.
Artificial intelligence based technologies.
You know and it's being use every day.
Something we don't see yet here in the U.S. So I think it's a great example of how to move forward. It's also showing up ways in which we can monetize our work in a guy.
And of course, the Japanese market is quite unique.
And.
And so yes.
Everything we learn in Japan won't translate into the rest of the world.
But in Japan doctors, using the index products sitting down with patients showing them. The reports that are coming from the bone anomaly.
Software and so in.
Japan, a complete integration of artificial intelligence into the treatment of men with prostate cancer and that provides us with a model as we will roll out here in the US whether you know our revenues will come from.
A pharmaceutical partner such as Fuji film in areas outside the United States or whether our revenues will come.
Through selling more p., while in 14 or for these business models world, we'll be exploring.
As you know chat but.
Great to see.
That continuing relationship with Fuji film, which has been going on.
Since 2011.
Alright, great. Thanks appreciate that appreciate all the insight.
Thank you Jeff.
Our next question comes from bar in the Middle of Jefferies.
Yes, hi, guys. Thanks for taking my questions.
Mark in the Q1 I think the company reported that you had 22 treatment requests.
And it seems this quarter of those you fulfill two of those.
I wanted to ask of the remainder 20, how many are currently continued requests and how many have dropped off I think you cited some of the reasons for dropping offer advanced disease, but I'm just trying to I guess quantify that number. So we know I guess how to think about the 30 to request that you have so far thanks yeah.
Thank you for that question Baron.
Treatment request not a great metric.
We've been providing the metric because we wanted to give insight to the launch early on.
But if you get into some of this complicated accounting that you're just talking about.
Well, we're not including in that number of patients that are have already been treated which include the patients treated in the second quarter and up and and now patients being treated in the third quarter.
We're not including in that number of patients who may drop off the list because that they it's no longer appropriate for them to get the medication. So but you are seeing a good growth in the number of patients that are making tree request. So as we mentioned our focus now is converting those patients to actually getting dose study and the commercial team quite focused on that and she and her medical team working with the Kale wells.
And.
You know the patients doctors.
And in order to get that moving.
The more traditional way to give you.
The view of our launch is a core sales and will be of course reporting sales quarter by quarter.
And we do expect by the end of the year that will begin to be able to make.
Sales forecasts as we gain experience with.
How did these treatment request turn into.
Patients who are actually dose how long does it take.
For that to occur and then what's the interval between the first dose in the second dose. So we're learning a lot about that now and expect to be able to.
Talk to the market about that.
By the time, we get to the end of the year.
Well, let me ask a question a little bit different so you know of the 22 to treatment requests.
If we just assume the two patients converted thats, a 9% conversion rate to treated patients.
Do you think that's a fair predictor for the 32 treatment requests should I be applying that in Q3.
That 9% because I mean that these things take time right. The treatment request comes through and then.
A number of things have to be done you have to verify the benefits. The hospital has to get ready you need the scheduling the patients have to schedule because they are going to have to go to the center and they'll have to stay in the lead in line room. So we are finding a lot of logistics.
You know that that have to be taken into account I think as I said by the time, we get to end of the year, we will be able to give you a better view of how many of these treatment requests do we think turn into actual sales and how long does that take.
But I would not view is yes.
That.
Just that two number to make calculations because we definitely expect the very significant amount of the treatment request to turn into actual dosing.
Got it and then on the basket study with that what does that draw that you're starting later this year.
We'll just be registration, enabling work it could lead to label expansion.
Yeah, we think so we don't have sign off from FDA on that but FDA highly encouraging.
To us to move ahead, so I think.
With good data.
I believe yes, we have an excellent chance to get label expansion based on this one trial and and you see us taking that seriously looking at a number of patients.
Well over 100.
Now, we're projecting 150 patients so we're making it a serious trial, we have definite FK a buy in as.
We will now be providing.
Treatment to patients who are totally out of options and thats highly motivating to the empty a NAND.
As we speak to the Kale wells, we see.
Great interest in.
Bringing his edra into these populations Asha how how would you describe the interest that you're seeing I would echo your comments mark the very very high unmet need for these patients who have either few available therapies or exhausted those options.
So you know our strategy of developing.
Radiopharmaceuticals that target Biomarkers basically.
And here, we see the FDA moving.
To a regulatory strategy that reflects that very approach and the ability to define a cancer that by its tumor origin. So called tissue agnostic approach, but looking at the Biomarket here the biometric marker being the ability for EMI BG as determined by a scan. So far we have now and FDA that has given us a regulatory path too. So we can exploit the fullest potential of these agents in terms of the indication and so our hope is with success. In this trial that we will have a broad label for and my Beachy AVOD patients and if you talk to patients.
With neuroendocrine tumors.
And you asked them are they EMI BG avid.
Thanks, Stan positive these are things that they know.
So we're seeing the potential that treatment in this space could be focused with azedra and with limited Terra, which as you know as a subset of Staten targeted agent and that patients might use both over the natural course of of of their disease.
And then.
A quick question on the end tab.
You mentioned that it came through last week.
Centers would receive.
Your maximum of $98500.
And then I guess through the DRG. These centers can receive anywhere from five to 20000.
And so.
Given the cost of is that it was a 150 K.
How does that or make up the difference.
From an tab.
And the DRG payment.
Total cost of that because.
I think on the.
You can see they would get anywhere. According my quick calculation anywhere from I guess, the 100 and.
3000 to $118000. So essentially they would still be out of pocket for upwards of up to $47000 per patient.
So.
These centers go through complex calculations, right and they are not necessarily looking to make profits.
But on the other hand, they have to bring their expenditures down so in the past they were looking at well $150000 basically less what they could get from the DRG, which was a significant barrier to then treating a Medicare Medicaid patient now it's come much closer as you point out.
It doesn't cover the full amount, but they have other revenue sources related to that patient brightest price. How are you. So I mean, all that all that is true but it is also true that there is a.
Another mechanism by which they can further reduce the gap, which is called the an outlier payment and they can apply for that and the.
It's.
It's something we'll be working closely with centers to make sure.
We help them understand.
That situation and they help us understand their particular is because it is different by center, let me suffice to say that the to your point. The gap that is left is actually above the threshold by which centers can apply for this further what they call outlier payments so.
The mechanism.
All the mechanism may never completely close the gap, but we feel that it can get even closer than what the impact would suggest so.
And I do think I do think there is a halo effect of all this right one.
So as a manufacturer we put in a lot of time and effort.
We've utilized the input of care wells of industry groups of our advocacy partners to get this done centers of excellence recognize that.
And and you know I think I think again.
We'll be working with them to as you suggest right. It is designed not to close the gap.
We can I think help them identify other avenues to further reduce it.
And there have been concerns about conventional MRV j. Lo specific activity, my BG and whether it might be competitive whether that are at which we really havent seen but.
Has been a legitimate concern.
But now we have CMS, saying no this new technology, Azedra, hi specific activity my BG.
You know is a.
It is worth it.
And we'll pay up to $98000 per dose.
So that Medicare and Medicaid patients will get it. So I think any concern that we would be seen conventional am IBG because its as Anders just too expensive for the hospitals I think thats falling away with a sense that payment and with the payments that price has just been describing.
Okay, and then maybe one last question on the pipeline.
Im Penknife five you cite that you want to go into a pivotal trial next year based on discussions with F.F.D.A. and also based on early data.
From the ongoing study so can you just discuss.
What this early data.
And why it gives you confidence to move into a pivotal study next year.
Well, we'll have to see the data certainly.
As we look at Pmeight targeted therapeutics, we're seeing a growing body of data that indicates strong efficacy for the PS in a targeted agents. So I think as we make our decision next year.
And not only will we be looking at our data, but also the data generated from other small molecule estimate targeted therapeutics such as 617.
I for one am, particularly going to be focused on the side effect profile of the drug as we see it being used.
Do we see significant advantages to the use of iodine as compared to booties sham or two alpha emitters.
And does the drugs seem well tolerated so far it has the side effect profile.
Around the salivary gland has been that during treatment with 10 95 there is.
Zero stoma dry mouth, but that reverses when treatment ends, whereas with some of the alpha emitters. There has been seen in a loss of salary Glenn function. So we will be looking closely both on the efficacy side.
Also on the side effects side.
Got it thank you.
Our next question comes from.
Deepak anchor with the Becker with Brooklyn capital.
Hi, Thank you.
Thanks for taking my questions I was wondering if.
If you can provide some more detail on what was done differently to debt.
This is already completed so much ahead of schedule.
You're talking about the condo our trial with P. why now that's right yeah, Yeah, and there is a definitive registrational trial, which our team got completed in nine months.
So I'm so pleased by that part of it is the work of art.
The Progenics team.
But part of it is what we call the power of P.Y. al that.
[laughter] patients and doctors want to have that image.
And so we attribute a lot of the speed of enrollment to the very strong desire to.
Get a few while images and a lot of that being generated by the fact that as data around P.Y. al is being presented as you know from prior quarters.
We have academic institutions that are making p., while themselves right. That's the power of people out of that they make it themselves and the reporting just astounding data about how that scan changes of course of treatment for the men and so if you're a doctor if you're a patient and you are saying well if we get a few while scan. Your course of treatment is going to change in a majority of the cases and.
Some in that one recent study 89% of the time. There's a change then you are going to want that picture. So I think it's a two elements a great effort by the team here and very strong desire by.
Patients and doctors to get some may images.
Yes, great great.
So I was wondering.
Even taking between the condo them out of the company level, it's going to be lower than.
So.
In other words from the secondary endpoint analysis in bundle Bbseven GLADO.
Understood Thats, an expedited timeline the landscape.
I'm not sure I'm understanding your question.
So I was just wondering if.
The secondary endpoint analyses in Pondel.
Might be useful in.
No getting more patients.
Due to the outside.
Yeah, No I think that the Condor trial will be sufficient to assuming we meet the.
The endpoint.
For submission.
So I think the condo Stan stand on its own the endpoints in the two trial in patient populations that were study slightly different.
Okay. Thank you.
Thank you.
I'm not showing any further questions to start like turn the call back over to Mr. Baker.
Thank you all again for joining US this morning to review our continued progress financial results and upcoming milestones. We look forward to speaking to you again soon thank you.
Ladies and gentlemen, does conclude todays presentation you may now disconnect and have a wonderful day.