Q3 2020 Epizyme Inc Earnings Call
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Ladies and gentlemen, today's conference. It's good to begin shortly please proceed with standby again todays conference. She comes to begin shortly please to teach them and thank you for your patience.
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Hello, and welcome to Epizymes Conference call.
At this time all participants are in the listen only mode.
There will be a question and answer session. After the prepared remarks.
You'd be advised that this call is being recorded EPS onto your question.
I would now like to turn the call over to Alicia Davis you may begin.
Thank you operator. This morning, we issued a press release outlining recent progress in our third quarter 2020 financial result.
The press release as well as our most recent corporate presentation can be found in the Investor section of our website at <unk> Dot com.
On the call with me is Rob pays more CEO, not Rod executive Vice President and Chief strategy and business Officer, Palatine Bessey, Chief Financial Officer, and Dr. Shi Polyester Walsh, Chief Medical Officer will join us for the acuity session.
Today's discussion will include forward looking statements related to Epizyme current plans and expectations, which are subject to certain risks and uncertainties actual results may differ materially due to various important factors, including those described in the risk factor section of our most recent forms 10-Q, 10-K and other SEC filings.
These forward looking statements represent our views as of this call and should not be relied upon as representing our views as of any subsequent date, we undertake no obligation to publicly update. These statements now let me turn the call over to Rob Rob.
Thank you Alicia and thank you all for joining us today.
2020, it's been an important year for Epizyme in terms of their significant milestones.
To the accelerated approval, sometimes derik in the U.S. and the transition to a commercial enterprise.
In addition, we announced this morning that we expanded our loan agreement with Farrakhan advisors, enabling us to draw down 150 million from the 300 million loan facility to further support our continued growth and commercial clinical and research execution.
Well this has been a year of unprecedented challenges for all of us are.
Our team has been resilient.
I'm proud of our accomplishments.
Since January our primary focus has been the successful commercial launches a tender for but apathy leeway sarcoma and follicular lymphoma, ensuring a positive first experience.
And enabling seamless market access and rapid delivery to patients.
Physician reaction to our label in both indication has been strong and key metrics that are important to tad barrick adoption tell us that even a bit because we'd 19 pandemic.
We are executing well and gaining traction in the patient segments, we anticipated based on their label.
Early launch experience reinforces our confidence has very long term market potential in these two indications, which we believe is reflective of the products attractive features as a simple to take oral medication with meaningful efficacy and a well tolerated safety profile.
In the third quarter, we recorded total net product revenue for Ted's, Eric a 3.4 million with growth over the second quarter, a 55% mainly driven by the approval and launch of 10th Derrick in for Lincoln lymphoma in late June.
We've had solid performance with our yes launch, which we were able to execute in a more traditional manner in the first quarter, we face to face physician engagement and leveraging a high level of awareness among the small community of sarcoma specialist, particularly on the heels of a successful ODAC panel.
We saw a quick uptake curve in the early months given the significant unmet medical need in this aggressive cancer and a lack of indicated therapies purchased had barracks approval.
As anticipated the uptake curve and started to normalize in recent months for this rare cancer population, but.
Well, we continue to see new prescription and refill orders for patients in both the frontline and later lines of therapy.
NFL once.
Once understanding the two unique indication statements physician reaction to the test Varick label has been very positive.
And they relate that it gives them a great deal of flexibility in terms of how they intend to use healthier for their relapsed refractory patients.
As a result of this we.
We are seeing prescriptions for both patients with easy age to activating mutations and wild type DCH too as well as untested patients for physicians don't feel the need to test.
Although prescriptions are mainly being written for third line and later patients which is in line with our clinical data we already see early signs of second line utilization as well.
And prescriptions are being written by both academic and community oncologists.
Most prescriptions coming from the larger centers, where the majority of patients are treated.
Since much access to test Barrick has been seamless with payer coverage in line with our label supporting broad use by physicians.
To date more than 50 published payer policies coverage has varied for FL, representing over 150 million lives.
This was aided by the rapid adoption of Tetbury into NCCN guidelines, the two way option for both wild type and D H mutation patients.
The vast majority of policies have no restrictive requirements or hurdles for cadbury beyond the label.
And as Derek has consistently delivered to patients within five to six days of a prescription being written.
That said, we did observe a slower than expected adoption of tests, there and can FL reflective of launching at the height of could be 19.
In the second and third quarters, many physician offices, where either close or F.L. patient visits were delayed.
Independent data shows a cancer patient visits were down by as much as 60% to 70% in April and remain down by over 30% in July.
This was likely even more exaggerated for indolent cancers like silicon lymphoma.
Not surprisingly this resulted in a roughly 20% to 30% decrease in U.S.L. patient starts across the industry on all lines of therapy.
We know physicians are hesitant to make a treatment change without actually seeing their patient in person and.
And although less l. visits to physicians are slowly returning to normal levels. Many of these visits are still being conducted virtually.
Despite this.
We are seeing increasing adoption of have Derek.
Our commercial and medical affairs team have been incredibly resilient with their efforts and since launch Weve reached 97% of our tier one and tier two accounts and 50% to 60% of positions within those accounts.
We've achieved post approval awareness of more than 80% among top tier position with.
With the greatest depth of awareness among those physicians, who had been in direct contact with our team.
We've achieved the highest share of voice in detailing among relapsed refractory S. L brands, suggesting that although access to physicians have been difficult.
Our virtual tactics have been successful in reaching them.
And Weve conducted numerous peer to peer engagements educational and promotional speaker programs all virtually.
Although this is translated into 60% of our tier one accounts already prescribing test, Eric and traction in new patient starts.
Since launched we've been tracking new prescriptions closely through secondary data, which looks at new patient starts on a rolling three month average.
The latest data from June which had there was approved late in the month through August and showed has been captured 8% of new FL prescriptions in the third line and later setting and 1% of new prescriptions in the second line setting.
While some accounts remain close industry representatives, and we haven't been able to get everyone. We.
We continue to adapt our launch efforts based on the current environment, which have resulted in increased awareness intent to prescribe test there.
And new patient starts.
We submitted and received approval from U.S. oncology for inclusion in their national practice guidelines for FL treatment.
And we're doing the same with other large oncology practices.
We've introduced novel peer to peer scientific engagement hearing a national opinion leader for the local opinion leader and educational programs, where our representatives had no direct access.
Participants in these programs indicate a high intent to prescribe has Derek.
We've introduced targeted outreach directly to patients and true lymphoma patient advocacy organizations to educate patients and caregivers on the importance of treatment. So they can proactively seek to reengage with their physicians.
We published the results from our Registrational trials in both yes, NFL the lancet oncology, providing complete results from our phase two studies, which can now be used by our field teams to educate physicians and finally, just last month, we introduced our Cadbury branded promotional campaign after ft, a pre clearance following our accelerated approval.
Overall, we're executing well on all aspects of our launches that we can control.
Our yes performance has exceeded expectations.
And despite a slower adoption ramp NFL than we had hoped we are seeing month by month increases in U.S.L. patient starts.
And are pleased to see prescriptions reflective of our broad label.
Importantly, nothing that we've encountered so far changes our view on the market potential for test, Derek and Twentytwenty, one and beyond.
Yeah under commercial activity, we're building on test barrick's value proposition through additional clinical trials and ongoing development to produce new data and to support expansion into new indications.
Patient enrollment is nearing completion for the state to run it for EPS confirmatory trial evaluating Teddy bear plus doxorubicin in frontline patients.
And for our FL confirmatory trial evaluating our squared plus has there in second line patients.
Completion of these safety run ins will enable us to initiate the efficacy portions of those studies early next year as planned.
We're also on track with all post marketing commitments for yes NFL.
In addition, weve completed enrollment up to the full 800 milligram dose it hasnt met OSAT in the safety run in of our metastatic castration resistant prostate cancer study, which is showing combinability of the full dose of tazemetostat with the enzalutamide and ever at home.
And we plan to move into the efficacy expansion stage early next year.
We anticipate reporting safety and clinical activity data from the safety run in CA 2021 patients are still being followed.
Financially, we closed the third quarter and strong position with 280 million in cash and cash equivalents.
Our total non-GAAP operating expenses for the quarter were 50.2 million split fairly evenly between R&D and <unk> expenses.
As we look to year end, we're updating our guidance for full year non-GAAP adjusted cash operating expenses to be between $215 million to $235 million.
From the previous 235 to 255 million.
This is due to a reduction in travel and other expenses as a result of our employees largely working virtually.
And a change in how our manufacturing expenses are recorded now the tetbury because of commercial product, which are partially offset by an increase in commercially related expenses to address the cove in 19 challenges.
Importantly to support our long term objectives, we have expanded our loan agreement with Farmacon advisors and affiliate with royalty pharma.
As a reminder, we.
We entered into an agreement last November for a 70 million loans with Farmacon to support regulatory milestones coach a site.
That agreement had an option to extend the loan to an additional 300 million after the F.L. approval.
And we have elected to draw down $150 million.
The terms are similar to the previous agreement the repayment schedule. It is favorably aligned with our expected revenue growth.
This was a strategic decision to further strengthen our balance sheet.
Signed a number of critical growth initiatives for Epizyme.
Our balance sheet of 280 million at the end of the quarter combined with the 150 million upon closing provide.
Provide us with approximately 430 million capital, which we believe will extend our operating runway into at least 2023.
In closing our vision is to rewrite treatment for patients with cancer, and we're executing that vision today, which had barrick.
While this year has presented us with a number of challenges that we never imagined we have an incredible team that is unwavering in our belief and in the long term value to test Barrett will provide in the future opportunities with our science. Thank.
Thank you all for joining us today well.
Well now open the line for questions.
Thank you.
As a reminder to ask a question will need to press star one of your telephone withdraw your question. Please press the pound key.
Please stand by we can politics when a roster.
And our first question comes from the line of Mohit Bansal with Citigroup. Your line is now open.
Great. Thanks for taking my question, Oh, probably thinking, though Hezbollah Oh, hey, good body.
Maybe I mean, weve Oh, so thanks for providing all these launch metric or so just thinking about the number you posted I'd say compared to the second quarter number which is probably predominant yes patient population. It seems like there's a 1.2 million implemented revenues and they like the way but pricing.
Good thing I get to about access to patients or so on a pretty patient that they get and it's just a.
Do the matter Bucks exhibition that the unit so quite drag so just thinking about it they quit what do you think when you say, 8% patients a new stock incurred line plus Oh can you just help us understand how what is the denominator in new money to do it because if I understand it correctly and I haven't seen one Peter dish.
Should be about 1500 or so patients come.
Coming in that and because that's 6000, but the yeah. So so.
[noise] <unk> coming in and even if it did quote we didn't do a cone excuse me 2000, plus so just trying to understand the math here.
Certainly so let me start and I'll I'll try and get to answer those questions and if I don't map packs you can jump in and help as well.
The 55% growth that we generated in the third quarter, we think predominantly came from growth in prescriptions in Follicular lymphoma.
Over what we saw in the second quarter effect.
It's actually in terms of generating an actual number of patients many of those scripts going through the specialty channels, especially distributor channel. So we don't have actual visibility to it but it's a combination of the offset of newts patients there were getting for FL.
So patients whove been on treatment for EPS dealing sarcoma, who maybe coming off so you lose some patients remember the average survival of inpatient without stealing it was her comments only about eight months. So we expect that at some point some of those patients would start to come off of therapy. The 8% of the third person. The prescriptions are just to put that number in context.
So of the total of the total relapsed refractory patient population you know that's a 12 cents or 10 to 12000 patient population, but in third line, specifically, where we're talking about it's about 6000 patients, but you don't have all of the patient starting a new drugs within a given month that number I gave you is a three month rolling average and really right.
At present, two months of launch effort for us because we werent approved until their end of June.
8%, a new prescriptions that happened and [noise].
Put that in context, you know that's that's a larger share of the new prescription share than we saw for our squared.
About the same or a larger share of the new prescriptions of any of the individual pediatric cases.
Oh, it's a larger share of new prescriptions and all of the good side of combinations put together.
But again this is where the impact of patients coming in you have to have new prescriptions and one of the things that really impacted this market in the third quarter was patients not coming in to see their physicians are those so does it being delayed but they just haven't been there we think that that's starting to correct itself. These patients had been away now for some time.
If you go to the slides that we posted in the corporate deck you can see that visits were down by as much as 70% to 80% back in April.
But they remain down by about 30%.
And even with those.
Visits coming back to something more related to normal many of those are virtual physical.
And we've heard on acquisitions spoken to a number of physicians myself to tell me that on a virtual call. They won't change a prescription for a patient they actually want to bring them in and examine them for they make a treatment change. So all of those have very represents a great profile for a drug for especially in the current environment, where they don't have to bringing in for testing they don't have to bringing in for pre treatment.
Any of those kinds of things they still want to see the patient and examine them before they started a new treatment and so that's the overall things that are influencing the uptake of Triferic. In these first few months of the launch [noise].
So that means it is basically motoki don't matter of executing and then getting the good. This is leading to large and you have this challenge. So in terms of looking at the month over month numbers can you just give us some sense of what you are looking beach, which gives you confidence in the future here.
Yes, it's a great question Mohit I mean, we're not giving guidance on sales beyond the period that we're talking about here in the third quarter, but we can tell you weve been pleased two things first of all even in the third quarter. We saw growth that started to accumulate in happened towards the end of the third quarter. So the unfortunate part from a revenue perspective is you don't get results on this patient says you're just you get the initial.
Scripts.
But we've continued even since then to continue to see increases in the number of physicians and accounts that are writing has Eric we continued to see increases in the new monthly prescriptions, which has very can touch that our view of the potential for Patrick NFL.
The 21, 2021 and beyond hasn't changed at all.
Physicians love the profile of this right.
And when they understand the label and the breadth of whats the label allows them how would allow them to prescribe a fair. They licensed drug very much. It actually is ideal and it goes it environment after they've gotten the patient in examining and made a treatment change, but I think the thing I'm. Most encouraged by when you ask you know long term outlook is the fact that we're getting use in both wild.
Type and actually we're getting used to pre group, while type mutants and untested India.
Indian Tester group is important because that means those are patients for which.
In addition to getting the feel that they needed to test and.
And we always knew that there would be some patients treated that way and that were already getting used in fact, it's showing up on the charts in terms of market share. We're already getting second line [laughter] Weve expected that we would get some that it will be modest, but we're already seeing that is occurring as well [noise].
Well. This is very helpful. Thank you Alf.
Thank you and our next question comes from the line of David Lebowitz with Morgan Stanley. Your line is now open.
Hello. Thank you very much for taking my question I guess my first question is how much insight I understand you're getting used to know in those three different FL populations, but how much insight do you actually get back from physicians exactly how they're using do you know for certain I guess, the the percentages that breaks down by those groups or is it more from.
Just casual feedback from sales personnel on on on what types of patients are being prescribed.
So I'll start and then perhaps I'll allow Matt to add to my comments that in terms of actually quantifying. It again most of the Follicular lymphoma prescriptions that we see go through the specialty distributor channel. So they sell into an account and we don't have immediate visibility into the type of patients being treated we will get that you can get it in retro.
Correct retrospective basis, but we need more than three months of launch runway to be able to have that we do spend a lot of time with physicians and we understand that a lot of the U.S. It's in patients who have ball type patients who are untested. This is not a drug is being predominantly used in D.C.H. two mutation patient population. So we're we're comfort.
With what we're seeing in terms of the split between them, although I can't give you a number.
Yeah, David Yes, it's Matt just to just to support Rob's comments absolutely. This this feedback is very consistent and really does reflect the broad nature of the product label and so.
It is being used you know broadly across the segments that that Rob just introduced.
The other thing I would David your question I'm, just another part of the answer to your question is.
The awareness that we created it has been I think very good considering this has been a launch weve done entirely virtually sort of have reached 80% awareness among our top tier positions is a good thing, but we also know that the depth of awareness varies whether we've been able to get to the person to person.
And so much of what companies like ours are doing right now interacting with people virtually but understanding the label it's important.
And when we're able to speak with physicians person to person it.
It becomes much more clear what the second part of that label allows and universally almost universally there.
They are very favorable and they understand how much discretion that gives them to prescribing test here. It can it changes how they use the drug so our focus right now is just making sure that we can get to every position we can person to person, it's not likely to be face to face because many of these accounts stilmar, allowing industry representatives in but even if it's on a phone call.
But I assume call or have or we get to them. It takes more time, it's definitely more work.
And that's a bit that is reflected a bid and what we've seen in the first quarter. This is it just takes longer to do it that way, but when we do the physician reaction to the tethadur profile been universally positive.
Thank you for that I'm also given that.
Certainly the number of cases have been spiking substantially of recent weeks.
Thanks.
Has that dynamic of improvements been holding or has generally been changing as you move into the early fourth quarter.
No in terms of my commentary on month by month increases in use we've seen month by month increases news even through that I think you know what's happened is those early months April May June timeframe rest showed you that the visits were down substantially.
A lot of patient Didnt come in at all now physicians are realizing they need to get these patients and they need to see them. These patients can't go forever without being seen and treat it and so they are starting to bring it back in even though about a third of those visits or virtual and if that's the case you know they just they feel the patient is progressing for they have an adverse event, they still want to see them, but.
They are they are bringing that back in I had a physician I spend time should probably Matt we actually see live with these positions in these large accounts.
I had a position that told me last week that he had to diffuse large b cell lymphoma patient. It came in they sent directly to hospice with no treatment if you've never done that in his career reason was he hadn't seen that patient in about four or five months because they were told not to come in and he progressed beyond the point that treatment could help them. So I think physicians are starting to realize.
Now this just can't go on even but could not going away they need to see these patients and they're trying to find ways to do that and we're spending our time trying to find ways to make sure. We can access these positions, even though the dynamic hasn't changed much because we don't know that it will change between now and into the year. So we're we're doing more and more things to make sure that even access for us doesn't improve.
We can still get the message to physicians about 10 Derek.
Thanks for taking my questions.
Thank you David.
Thank you and our next question comes from the line of Michael Yee Jefferies. Your line is now.
Hey, guys. Thanks for the question I had a two part question, but they're related first as a follow up on my.
Our next question and looking at the chart shows about 8% share and trying to lie.
Connect that with Oh.
Slide slide eight which actually shows five months, how many new people are starting can you just clarify you think theres about 1200 people starting liketo lymphoma therapy per month.
And should therefore actually when we do the same math to get to about 70 80 patients guess you've divided by I think you know a death in the quarter 3000 people starting that's around three 3% to 8% show do you actually think there's 1000 people starting per month and if they are.
900 people out of the thousand are getting something else, maybe just connect that does that surprise you and then the second part is if.
What we're saying is Kobe dish part of the NPAC here and you know kind of be bring people. When do you just think that.
We just need a lot more.
Resolution around Covanta, we'd expect that to get at.
Better ramp.
Maybe just connect those two dots snacking.
Certainly so let me explain to the chart that looks at a number of new business that does not represent that.
Total number of new Follicular lymphoma patient a prescription in a month by month basis in the footnotes. If you read. It. This is actually a survey that is done it's a syndicated data that we purchase but it's based on a sample of physicians and they basically feel that they have a high enough sample to be able to project changes as they do here with the reductions in prescriptions.
But it doesn't mean this is only of the sample of the I think it's 179 positions that they sample. So thats not the total number of new FL patient starts in the country [noise].
Each year, it's a sample that gives them a sense of being able to [noise].
Yep.
At a macro level.
In terms of the 8% [noise].
All that said and I think we've had in our corporate deck before slides that show the actual use of individual drugs and it's a fragmented category. That's why we've always said, it's a it's a group of patients where there is no real standard of care you know each.
Each of the other independent.
Pithree kinase is have between eight or lower percent share our share of the 8% that we reported in the third line. In later setting is actually higher than our squared which is impressive in the third line setting a lot of the R. Squared use had actually been in the third line is starting to move up a bit earlier, but had been in the third line, it's better than the good side of combinations.
Combined it's as good or better than any of the Pithree kinases, and again Thats just really two months of launch activity because that was data that was cut in August on a three month rolling average. So again, that's not the number that we expect will be out eventually but for two months of launch on a three month Rolling average we feel very good that that represents.
A strong adoption early on.
Should you think it's actually higher than that because that's a sampling how does he think it's higher than a thousand per month and again, if its higher than that you think that 92% of these people are getting something else.
And they're coming in and getting something 'cause it should start showing just gets interpretation I think that what they're saying, they're getting a different drug.
So I think what what that means I don't actually know what the number that I don't think anyone knows what the actual number of new FL starts is per month again. This is based on a sampling and they try and project percentage changes. That's really what this is focused on I think what happens Mike in reality in a third line market third line patient and Shefali can speak to that.
Just from a clinical point of view as well as these patients are on something.
They're on something and many times, it's an off label drug it may be a fruit and it may even need to clecs.
They're on something.
And in many cases, the drugs that they get treated with actually only go for a certain period of time in the end and then they monitor them until they progress. So a good example is our square to choose for year they stop it.
And then they monitor those patients until progression and so many of them are actually being treated with something but until something triggers the physician or the patient to diagnose themselves is not doing well being symptomatic.
And say I need to go back in and see the physician a treatment changes that made but it's not that they are sitting there on nothing unless it's just because the treatment cycle for their drug to ended in they're waiting to see when they progress.
Yeah.
Yes, as I said, probably put money I think it is very different than a aggressive tumor type in lymphoma is defined as Rob mentioned it likely that you know patients if you'll pardon and then beyond that on something but I listed symptomatic they don't come to fruition and the physicians don't have the patients they want the scans and they want to know that the patients are progressing to make a critical tool.
So it's important that the patient comment it's very different from aggressive tumors like best another they see them often because all the NBC out because it's more aggressive.
Okay got it thank you guys.
Thank you.
Our next question comes from the longest Lawson with Barclays. Your line is now open.
Great. Thanks, so much just wanted an update on her for that so you'll you'll see in these these trends get essentially better through three Q2 towards the industry Q and into October as well.
That's right you know and we hear it anecdotally as I said, Matt Ali and I and others are on the phone with these physicians quite a bit they are telling us the same thing that they've gone long enough. They want to see these patients they want them back in and so we yes, we expect that the that the rate of the patient visits is starting to improve.
Some of its virtual you know about a third of it is virtual because in the case. These are elderly patients remember so they fall into a high risk category. When it comes to covert so we've taken it all arranged to see them virtually they're doing it that way and then if they detect that there was an issue patients have them not doing well for symptoms then they'll bring them in in order.
But it's just one more step to get to the treatment change ultimately physicians like this drug and they like it particularly for these patients who they don't want to continue to bring in for pre treatment or infusion. It works really well, but they have to get to that step of making a treatment change.
And then Peter it's Matt just to build up of Rob's point, we continue to see either and are pleased that we see month month over month increase in adoption and despite the challenges with cobot and I think that's very much reflective of the broad nature of the label in the impression that physicians are having in the context of how they can use the drug which were for.
Next.
Not only the third line and later use that Robert circulated that even the opportunity now that is presenting itself in second line, where we've we've observed prescribing as well.
Good.
How much visibility do you have.
How much of this is is it blocks because of kind of the quality of that.
Do you feel you have enough data to.
Get comfortable about what Fourq you could look like.
Internally at least.
Yeah, well the.
Vast majority of the did a deal or the prescriptions are going through the specialty distributor. So at the forefront of that where we don't have the availability or visibility into where these scripts are going so what we'll be doing is actually following goes through pollution claims databases those lag essentially about two months.
So which is why qualitatively no we're continuing to see the right types of improvements in prescription growth, but we'll have a more formal number with regard to that as those data bases come through and we have the ability to see exactly where they were.
Right.
Just a final question around that with this kind of dynamic you've seen with.
Patient stuff some of it.
Should we kind of look at Threeq. It was kind of a new base to grow from or is it still from Citi.
[noise] plumbing Threeq <unk> Threeq you is a is a is a base to grow from in the first place to go to the first quarter of launch. So we really didnt have a baseline and what I would say is as a baseline number that number has been it's been more difficult because of the challenges that could just.
Resented just in terms of the initial uptake I think all of the things that we pointed to in terms of how we're executing we're very pleased with particularly the types of patients that are being treated but we expect that this will only get better as the dynamics around cobot get better as physicians say I need to see these patients and patients demands go in.
Well one of the other things that were doing Peters were directly going to patients now with.
Educational programs to help them understand they can't stay away from the physician office you know they have is they have a malignancy it needs to be treated they need to be seen and they need to be cared for so we're pushing on both the patient side as well as on the physician side and we're pleased to see that that that happens, even though theres you know their guidelines like cash guidelines that came out that talked about being more.
Prudent with indolent lymphomas. Many physicians now are starting to say Wow. That's no. We can't do that anymore. We have to see these patients and so we think that our our ability to continue to access. These positions is important even with Covance. We're doing everything we can to make sure. We can access them, but I do think that we see improvement coming as the.
As the cobot pandemic starts to have less of an impact because these patients just need to be seen and we're seeing that in the prescriptions as well.
Great. Okay. Thanks, so much thanks for taking the questions.
Thank you and our next question comes from the line of you're wrong Werber with Cowen Your line is open.
Yes, hi, good morning, how are you.
Hi, Good morning, a couple of questions number one it seems like 60% of accounts.
Prescribed because very core the first here what about the second tier what some you can come to is it that is a very small practices that just don't have a lot of patients or what though and if you could share some of those start summed up here.
I'll I'll start I mean, I think first of all I'll explain what the tiers are and then Matt can go into a bit more detailed that tier one and tier two together when you take them combined it's it's probably around 800 accounts. So these are it's a large number of accounts that these are the accounts are cheering.
Based on the volume of FL patients that they actually see and.
And so when our axis has constrained we've really put a heavy emphasis on making sure that we can first get to these tier one and tier two accounts because these are the ones managing the bulk of the patient. So we feel good that weve done a good job in terms of achieving awareness, there and a fairly high level of those accounts already having prescribed a patient I'll I'll, let Matt.
Explain more about the tears and answer your question directly.
Yeah, no I'd, rather be that certainly with regard to the success. We've had thus far we're focusing really in the top level of prescribers, we've seen adoption in both areas.
Areas in both tier one and tier two of course, the tier ones are areas, where there's the greatest volume. So naturally that's where the organization is focusing but we've certainly seen adoption in both tiers.
And we will continue and we will be closely monitoring.
Forward into the fourth quarter and into 21.
Okay, but I assume is tier two sort of in the 30% of the total half of tier one or any any any sort of hint.
Yeah, it's still we're still tracking that performance in the all of the accounts that were calling on it at the moment, but certainly we've seen adoption across all the tiers with what the bullets really being in that tier one setting.
Okay, and then you have coverage for about a 150 million lives you know obviously, it's about half half the country I'm not sure any sense as to is this sort of more on the Medicare supplemental is it sort of more figure denominated or what the plans to kind of expand the coverage.
Well, we've been very pleased with the coverage to date as Rob pointed out in his comments over 50 plans covering and writing policies per test or Krefeld as you know you round. The the coverage for for that fell in the population is a more Medicare based population, but we've been successful in implementing these policies we believe that.
Very much consistent with.
You know the awareness that we created well before the approval and we've continued to have success in that regard. So there's been no barriers to access for the brand, which will continue to be very pleased with and we just continue to move down that path, but the payer community.
Between now and the end of the year.
Okay, our metrics on that with our metric that we're tracking on it and if you'll recall the EPS helio circled a large fleet by six months and we had 90% of the of coverage of all plans.
Those lives were covered we're better king something very similar for Follicular lymphoma.
He would have approximately 90% of lives that would be covered in around six months or so after but if it if they don't have a public policy. It doesn't mean, they're not covering 10 Derek.
Those plans that don't have a published policy most of them have interim plans in place that allow for coverage for Ted there again because of that we're really not seeing denials of claims for FL, whether its a plan thats published their their policy or one that's still in the warehouse.
Okay great.
And then should probably just for you metastatic prostate cancer. So look we're going to have data from the phase one b to run and safety data next year is it potentially to ask could you you and is there going to be efficacy and outlook. Thank you.
[noise] ship, all you might be on mute.
Well I'll jump in it it could be that sometimes she has connectivity issues that could be sheet sheetrock. So for the castrate resistant prostate cancer study weve been very pleased.
Well, it's actually a number of things on that we've been pleased with the rate of enrollment despite co that weve never seen a slowdown in enrollment in this study there's been a high degree of interest.
The physicians who've been a part of it we are we've completed enrollment all the way up to the 800 milligram dose as.
As I said in my opening remarks, we've not seen any dose limiting toxicities with either into Luna my or ever at around.
And based on that safety results and activity. We've already made the decision to move forward to the efficacy portion of the study. So we'll have more on that as we start the study next year and we would look to present. These data yes at a medical meeting next year. So that you can see both the safety and the activity that weve observed so far but we've not talked about those numbers because we actually saw.
Hi patients actively on treatment.
Great. Thank you.
Thank you and our next question comes in the line of Andrew Barents with SVB <unk>. Your line is now open.
Hi, Thanks for the questions.
Or two from me. Please the first one has to do with the existing treatment paradigm for FL. Thanks.
I think one thing we've heard consistently from the K wells is a clap stuff goes in indolent disease, and then many patients are in the wet and their willingness to see can accept treatment at this point in their life I'm wondering if there's any way to actually change that or is this a case that I felt opportunity could remain somewhat elusive until the drug can get earlier treatment stages.
The disease and.
And then I just have one about the label we're hearing that most centers, especially in the community. They don't have standalone easy access to testing and most doctors don't know who's each to positive in their practice, how long do you think it will take to implement standalone testing of the communities as a treatment paradigm.
It's a good question I'll I'll feel the first and then I'll let.
Let Matt answer the second question with regards to testing.
I think your point about some of these patients you're right. It's in fact, we talked before about the fact that in research that we've done when we tried to size the opportunity.
We uncovered and this is through actual chart audits assistant physician reports physician perception for chart audits about 10% of patients come off treatment.
At every line of therapy and they don't go back on treatment and predominant reason for doing that is they're not satisfied with the options that are offered to them. They either don't want to have to tolerate the toxicity.
They can't tolerate the toxicities it may be something they are contra indicated too and so at every stage about 10% of patients come off their drug essentially been sitting on the sidelines.
So we think that that is an opportunity for tests Eric.
I launched since I T Guy in the prostate cancer market. We saw the exact same thing happened. There are many men have decided they didnt want another route chemotherapy. They came off many of them into hospice and they were choosing no treatment until apparatus them came along and salute them I did actually expanded the market. So we think that that potential exists here as well and that the profile.
Very well suited to them because it's oral can take it at home it's safe it's.
One that doesn't require a lot of monitoring and going back to the position, but you know.
I think this is an opportunity we believe that we'll have more potential to tap into.
After we get through the cobot pandemic, it's per physician per patients who already are coming in to see their physicians and to have active disease. These patients are likely not seeing their physicians is often now. So we think this is a 2021 opportunity and beyond more than in the fourth quarter of this year, but we clearly see it as an opportunity we think the profile for tests Eric is ideal.
The students are those patients.
Now I'll, let you address discussion of testing yeah.
Yeah. Good morning, so with regard to testing new we continue to heal up here from the physician community.
From our field based teams as well as our own research that.
The bear the test is not being is a bear is not a barrier to use at all given the broad nature of the label.
As physicians are considering Tesla, Eric if they are to test they'll test their patients to help just effectively managed to the dialogue that they'll have between themselves and the patient provider given the differences in the objective response rates, but by and large right. Now you know for those who wish to test they've been able to test at the local level, albeit perhaps and.
Our academic centers or in local labs, and those had been reimbursed for but we don't see testing getting in the way of adoption at this point.
Do you have a number of how many patients prescribed the drug is actually the best.
Yeah, that's something that still work, we're tracking very closely and when we have a greater level of granularity around that with more quantitative measures, but we'll be sharing that.
Okay. Thanks.
Thank you and our last question.
Thank you and our last question comes from the line of David Nierengarten with Wedbush. Your line is analysis.
Hey, Thanks for taking my question on going into the launch in detail.
What.
One question I have is there any potential to change that ER doctors viewpoint that they need to see the patient and examine him or her before I'd treating ties very like you have.
In a you know, let's say in a community practice were one physician prescribing so patient could there's a colleague you.
You have to see the results and then you know forgo an examination or is this really necessary for all patients to get on the scrip I understand it that would be but I'm curious if there's any.
Leeway, there going forward with more physician experience. Thanks.
[noise], it's a it's a really great question and I've I, it's hard to speculate on whether that would change I do expect that.
Big part of this is based on what you said its position experience. This is so on top of everything else that we talked about the dynamics oftentimes when physicians are seeing their patients writing something new that theyre I'm familiar with and they're not accustomed to what might happen is just one additional element to think about for physician Fortunately for us the safety profile is actually.
Very favorable, but it's still one that's unfamiliar so it could be that once physicians have experience and they are willing to do they are willing to use has barrick without seeing the patient, but I don't think it even has as much to do with the with the drug itself. It has to do with knowing where their patient is and how they're doing and so I I've asked this question and again.
This is or at least to this may change in two or three months, but as I'm on the phone with physicians I specifically asked the question if you're seeing a patient virtually would you ever would you use CAD barrick or make any treatment change unless you bring the patient in.
And almost universally the answer is I want to see the patient I want to physically examined them I want to understand where they are because that could affect the way I think about treating them what they may tolerate and so forth. So I think that it's more about understanding the patient and the condition of their disease and there are other health status before deciding which treatment to give them.
Yeah, Hi, Thank you I will pass on interest so sorry, just nothing concept with Rob's comments and okay.
Good yeah. So I think yes, I think one of the things that person is actually you know I bring now as I've said, if they have anything else to patients. They are trying to help them understand that that is what is that you need to think then initially then cool they cannot go up a bit you know people didn't know how to react and I think people are incredible production guidance.
I think there's more to come however, I think we just have to remember that this isn't Golden pass <unk> basin.
Jason This is symptomatic.
Eddie just wondering about the fact that they that's hard for them to get them toward the clinic.
Understood. Thank you.
Thank you.
Does include today's question and answer session I would now like to turn the call back to laugh when it goes into March.
Great well. Thank you all for joining us today. Thank you for the really great questions. We look forward to keeping you updated on our progress and we hope you all have a safe and healthy a day and we'll talk again soon take care.
Ladies and gentlemen. This concludes today's conference call. Thank you for participating you may now disconnect [noise].
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