Ipsen S.A.

Thank you, operator. This morning, we issued a press release outlining recent progress in our third quarter 2020 financial results.

That press release as well as our most recent corporate presentation can be found in the Investors section of our website at epizyme.com. On the call with me is Rob Bazemore, CEO; Matt Ros, Executive Vice President and Chief Strategy and Business Officer; Paolo Tombesi, Chief Financial Officer; Dr.

Shefali Agarwal, Chief Medical Officer, who will join us for the Q&A session. Today's discussion will include forward-looking statements related to Epizyme's 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 Factors section of our most recent Forms 10-Q, 10-K, and other SEC filings. These forward-looking statements represent our views as of the 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 has been an important year for Epizyme in terms of our significant milestones, with two accelerate approvals of TAZVERIK in the US and the transition to a commercial enterprise. In addition, we announced this morning that we expanded our loan agreement with Pharmakon 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.

While this has been a year of unprecedented challenges for all of us, our team has been resilient. And I'm proud of our accomplishments.

Since January, our primary focus has been the successful commercial launches of TAZVERIK for both epithelioid 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 TAZVERIK adoption tell us that, even amidst the COVID-19 pandemic, we are executing well and gaining traction in the patient segments we anticipated based on our label.

Our early launch experience reinforces our confidence in TAZVERIK's long-term market potential in these two indications, which we believe is reflective of the product's 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 TAZVERIK of $3.4 million, with growth over the second quarter at 55%, mainly driven by the approval and launch of TAZVERIK in follicular lymphoma in late June.

We've had solid performance with our ES launch, which we were able to execute in a more traditional manner in the first quarter with face to face physician engagement and leveraging a high level of awareness among the small community of sarcoma specialists, 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 prior to TAZVERIK's approval.

As anticipated, the uptake curve has started to normalize in recent months for this rare cancer population. But we continue to see new prescriptions and refill orders for patients in both the frontline and later lines of therapy.

In FL, once understanding the two unique indication statements, physician reaction to the TAZVERIK label has been very positive. And they're elated it gives them a great deal of flexibility in terms of how they intend to use TAZVERIK for their relapsed refractory patients.

As a result of this, we are seeing prescriptions for both patients with EZH2 activating mutations and wild-type EZH2 as well as untested patients where 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, with most prescriptions coming from the largest centers where the majority of patients are treated. Since launch, access to TAZVERIK has been seamless, with payer coverage in line with our labels, supporting broad used by physicians.

To date, more than 50 published payer policies cover TAZVERIK for FL, representing over 150 million lives. This was aided by the rapid adoption of TAZVERIK into NCCN guidelines for 2A option for both wild type and EZH2 mutation patients.

The vast majority of policies have no restrictive requirements or hurdles for TAZVERIK beyond the label. And TAZVERIK 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 TAZVERIK in FL, reflective of launching at the height of COVID-19. In the second and third quarters, many physician offices were either closed or FL patient visits were delayed.

Independent data show that cancer patient visits were down by as much as 60% to 70% in April, and remained down by over 30% in July. This was likely even more exaggerated for indolent cancers like follicular lymphoma.

Not surprisingly, this resulted in a roughly 20% to 30% decrease in new FL patient starts across the industry on all lines of therapy. We know physicians are hesitant to make a treatment change without actually seeing their patients in person.

And although FL 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 TAZVERIK.

Our commercial and medical affairs team have been incredibly resilient with their efforts. And since launch, we've reached 97% of our tier one and tier two accounts, and 50 to 60% of physicians within those accounts.

We've achieved post approval awareness of more than 80% among top tier physicians, with the greatest depth of awareness among those physicians who've been in direct contact with our team. We've achieved the highest share of voice in detailing among relapsed refractory FL brands, suggesting that although access to physicians has been difficult, our virtual tactics have been successful in reaching them.

And we've conducted numerous peer-to-peer engagements, educational and promotional speaker programs, all virtually. All of this has translated into 60% of our tier one accounts already prescribing TAZVERIK interaction and new patient starts.

Since launch, we've been tracking new prescriptions closely through secondary data, which looks at new patients starts on a rolling three month average. The latest data from June when TAZVERIK was approved late in the month through August and shows TAZVERIK 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 closed to industry representatives and we haven't been able to get to everyone, we continue to adapt our launch efforts based on the current environment, which have resulted in increased awareness, intent to prescribe TAZVERIK and new patient starts. We submitted and received approval from US 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 engagements, pairing a national opinion leader to the local opinion leader in educational programs where our representatives had no direct access.

And participants in these programs indicate a high intent to prescribe TAZVERIK. We've introduced targeted outreach directly to patients and through 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 publish the results from our registrational trials in both ES and FL in The Lancet Oncology providing complete results from our Phase II studies, which can now be used by our field teams to educate physicians. And finally, just last month, we introduced our TAZVERIK branded promotional campaign after FDA preclearance following our accelerated approval.

Overall, we're executing well on all aspects of our launches that we can control. Our ES performance has exceeded expectations.

And despite a slower adoption ramp in FL than we had hoped, we are seeing month-by-month increases in new NFL 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 TAZVERIK in 2021 and beyond.

Beyond our commercial activities, we're building on TAZVERIK'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 safety run-ins for our ES confirmatory trial, evaluating TAZVERIK plus doxorubicin in frontline patients and for our FL confirmatory trial evaluating R2 plus TAZVERIK in second line patients.

Completion of these safety run-ins will enable us to initiate the efficacy portions of both studies early next year as planned. We're also on track with all post marketing commitments for ES and FL.

In addition, we've completed enrollment up to the full 800 milligram dose of tazemetostat in the safety run-in of our metastatic castration resistant prostate cancer study, which is showing combinability of the full dose of tazemetostat with both enzalutamide and abiraterone. 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 2021 if patients are still being followed. Financially, we closed the third quarter in a 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 SG&A 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 million 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 that TAZVERIK is a commercial product, which are partially offset by an increase in commercially related expenses to address the COVID-19 challenges. Importantly, to support our long-term objectives, we have expanded our loan agreement with Pharmakon Advisors, an affiliate of Royalty Pharma.

As a reminder, we entered into an agreement last November for a $70 million loan with Pharmakon to support regulatory milestones [indiscernible]. That agreement had an option to expand the loan to an additional $300 million after the FL approval.

And we have elected to draw down $150 million. The terms are similar to the previous agreement, with a repayment schedule that is favorably aligned with our expected revenue growth.

This was a strategic decision to further strengthen our balance sheet and fund 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 us with approximately $430 million in 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 through TAZVERIK.

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 has a long-term value that TAZVERIK will provide and the future opportunities with our science. Thank you all for joining us today.

We'll now open the line for questions.

Thanks for providing all these launch metrics. So, just thinking about the number you posted and if I compare it to the second quarter number, which is probably predominantly ES patient population, it feels like there is a $1.2 million incremental revenues.

And if I divide by price and everything, I get about like 60 patients or so on 30 patient average. And if we just do the math, about 60 patient at the quarter-end.

So, just thinking about it. when you say 8% patients of new start in third line plus, can you just help us understand what is the denominator and numerator there?

Because if I understand it correctly, every three month period, there should be about 1,500 or so patients coming in there because there are 6,000 every year. So, 1,500 folks coming in.

And even if you take COVID into account, it should be 1,000 plus. So, just trying to understand the math here.

Let me start and I'll try and get through each of those questions. And if I don't, Matt, if 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. In terms of generating an actual number of patients, many of those scripts go through the specialty distributor channel.

So, we don't have actual visibility to it. But it's a combination of the offset of new patients that we're getting for FL.

Also patients who've been on treatment for epithelioid sarcoma who may be coming off, so you lose some patients. Remember, the average survival of a patient with epithelioid sarcoma is only about eight months.

So, we expect that, at some point, some of those patients would start to come off the therapy. The 8% of the prescriptions, just to put that number in context.

So, of the total relapsed refractory patient population, that's a 10,000 to 12,000 patient population. But in third line, specifically where we're talking about, it's about 6,000 patients.

But you don't have all of those patients starting a new drug within a given month. That number I gave you is a three-month rolling average and really represents two months of launch effort for us because we weren't approved until the end of June.

So, 8% new prescriptions that happen. And just to put that in context, that's a larger share of the new prescription share that we saw for R2.

That's about the same or a larger share of the new prescriptions of any of the individual PI 3-kinases. It's a larger share of new prescriptions than all of the Gestiva 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 or those visits 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 could see that visits were down by as much as 70% to 80% back in April. But they remained down by about 30%.

And even with those visits coming back to something more related to normal, many of those are virtual visits. And we've heard from physicians, spoken to a number of physicians myself who 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 before they make a treatment change. So, although TAZVERIK represents a great profile for a drug, especially in the COVID environment where they don't have to bring them in for testing, they don't have to bring them in for pre-treatment, any of those kinds of things, they still want to see the patient and examine them before they start a new treatment.

And so, that's the overall things that are influencing the uptake of TAZVERIK in these first few months of the launch.

So that means it is basically more of – matter of executing and then getting – this is early in the launch 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 which gives you confidence in the future here?

It's a great question, Mohit. We're not giving guidance on sales beyond the period that we're talking about here, the third quarter, but we can tell you, we've been pleased.

Two things. First of all, even in the third quarter, we saw growth that started to accumulate and happen towards the end of the third quarter.

So, the unfortunate part from a revenue perspective is you don't get refills on this patient. Those are 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 TAZVERIK. We continue to see increases in the new monthly prescriptions for TAZVERIK and such that our view of the potential for TAZVERIK in FL in 2021 and beyond hasn't changed at all.

Physicians love the profile of this drug. And when they understand the label and the breadth of what the label allows them, how it allows them to prescribe TAZVERIK, they like this drug very much and actually is ideal in a COVID environment after they've gotten the patient in, examined them and made the treatment change.

But I think the thing I'm most encouraged by, when you ask long-term outlook is, the fact that we're getting used in both wild type – actually, we're getting used in three groups. Wild type use and untested.

And the untested groups is important because that means those are patients for which physicians getting the feel that they needed to test. And we always knew that there will be some patients treated that way and that we're already getting used.

In fact, it's shown up on the charts in terms of market share. We're already getting second line, which we'd expected that we would get some, but it will be modest, but we're already seeing that occurring as well.

I guess my first question is how much insight – I understand you're getting used in those three different FL populations, but how much insight do you actually get back from physicians exactly how they're using it? Do you know for certain, I guess, the percentages that break down by those groups?

Or is it more from just casual feedback from sales personnel on what types of patients are being prescribed?

So, I'll start and then perhaps I'll allow Matt to add to my comments. But 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 patient that's being treated. We will get that.

You can get it in a 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, though. And we understand that a lot of the use is in patients who have wild type, patients who are untested.

This is not a drug that's being predominantly used in EZH2 mutation patient population. So, we're comfortable with what we're seeing in terms of the split between them, although I can't give you a number.

It's Matt. Just to support Rob's comments, absolutely.

This feedback is very consistent and really does reflect the broad nature of the product label. And so, it is being used broadly across the segments that Rob just introduced.

The other thing I would – David, to your question, just another part of the answer to your question is the awareness that we've created has been, I think, very good, considering this has been a launch we've done entirely virtually. So, to have reached 80% awareness among our top tier physicians is a good thing.

But we also know that the depth of awareness varies whether we've been able to get to person to person. And so, much of what companies like ours are doing right now is interacting with people virtually, but understanding the label is important.

And when we're able to speak with physicians person to person, it becomes much more clear what the second part of that label allows. And universally, almost universally, they're very favorable when they understand how much discretion that gives them to prescribing TAZVERIK and it changes how they use the drug.

So, our focus right now is just making sure that we can get to every physician we can person to person. It's not likely to be face to face because many of these accounts still aren't allowing industry representatives in.

But even if it's on a phone call or a Zoom call or however we get to them, it takes more time, it's definitely more work. And that's a bit – that is reflected a bit in what we've seen in the first quarter.

It just takes longer to do it that way. But when we do, the physician reaction to the TAZVERIK profile has been universally positive.

Also, given that the number of cases have been spiking substantially of recent weeks, has that dynamic of improvements been holding or has the trajectory been changing as you moved into your early fourth quarter?

No, in terms of my commentary on month-by-month increases in use, we've seen month-by-month increases in use even through that. I think what's happened is those early months, the April, May, June timeframe where I showed you that the visits were down so substantially, a lot of patients didn't come in at all.

And now physicians are realizing they need to get these patients in, they need to see them, these patients can't go forever without being seen and treated. And so, they are starting to bring them back in, even though about a third of those visits are virtual.

And if that's the case, if they feel the patient is progressing or they have an adverse event, they still want to see them. But they are bringing them back in ahead of physician – I spent time, Shefali, Matt, we actually speak live with these physicians in these large accounts.

I had a physician that told me last week that he had two diffuse large B cell lymphoma patients that came in, they sent directly to hospice with no treatment. And he'd never done that in his career.

The 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 him.

So, I think physicians are starting to realize now this can't go on, even with COVID 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 physician even though the dynamic hasn't changed much because we don't know that it will change between now and the end of the year. So, we're doing more and more things to make sure that even if access for us doesn't improve, we can still get the message to physicians about TAZVERIK.

I had a two-part question, but they're related. First as a follow-up on Mohit's question and looking at the charts about 8% share and trying to connect that with slide 8, which actually shows by month how many new people are starting.

Can you just clarify? You think there's about 1,200 people starting a follicular lymphoma therapy per month?

And so, therefore, actually, when we do the same math, we get to about 70, 80 patients. Guess you would divide it by the cumulative in the quarter.

3,000 new people starting? That's around three 3% to 8%.

So, do you actually think there's 1,000 people starting per month? And if they are, 900 people out of 1,000 are getting something else?

Maybe just connect them? Does that surprise you?

And then the second part is, if what we're seeing is COVID is part of the impact here and it takes time to bring people in, do you just think that we just need a lot more resolution around COVID to really start to get a better ramp? Maybe just connect those two dots.

Thanks.

Let me explain. The chart that looks at the number of new visits, that does not represent the total number of new follicular lymphoma patient prescriptions in a month by month basis.

In the footnotes, if you read it, this is actually a survey that's done. It's syndicated data that we purchased.

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 physicians that they sampled. So, that's not the total number of new FL patient starts in the country each year.

It's a sample that gives them enough sense of being able to project at a macro level. In terms of the 8%, I think we've always said – and I think we've had in our corporate deck, the 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 group of patients where there is no real standard of care.

Each of the other independent PI 3-kinases have between 8 or lower percent share. Our share, the 8% that we reported in the third line and later setting, is actually higher than R2, which is impressive in the third line setting.

A lot of the R2 use had actually been in the third line. It's starting to move up a bit earlier.

But it had been in the third line. It's better than the Gestiva combinations combined.

It's as good or better than any of the PI 3-kinases. And again, that's with 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 of those? Do you think it's higher than the 1,000 per month?

And again, if it's higher than that, do you think that 92% of these people are getting something else and they're coming in and getting something because it just starts, just so we just get the interpretation? I think that's what you're saying, they're getting a different drug.

I think what that means is – I don't actually know what the number of 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 patient – and Shefali can speak to this from a clinical point of view as well – is these patients are on something, they're on something, and many times it's an off-label drug. It may be ibrutinib, it may be venetoclax.

They're on something. And in many cases, the drugs that they get treated with actually only go for a certain period of time and then they end and then they monitor them until they progress.

So, a good example is R2. It's used for a 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 as not doing well, being symptomatic, and say I need to go back in and see the physician, a treatment change is made. But it's not that they're sitting there on nothing unless it's just because the treatment cycle for their drug ended and they're waiting to see when they progress.

This is Shefali. I think it is very different than an aggressive tumor.

Follicular lymphoma is different, as Rob mentioned, rightly, that patients are – if you're third line and beyond, they're on something. But unless they're symptomatic, they don't come to physicians.

And if physicians don't have the patients, they won't do scans and they won't know that the patients are progressing to make a treatment change. So, it's important that the patients come.

And it's very different from aggressive tumors like breasts and others where they see them often because DLBCL, because it's more aggressive.

I just want to clarify that. So, you're seeing these trends get essentially better through 3Q – towards the end of 3Q and into October as well?

That's right. And we hear it anecdotally, as I said.

Matt, Shefali 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, yes, we expect that the rate of the patient visits is starting to improve. Some of it's virtual.

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 COVID.

So, if they can at all arrange to see them virtually, they're doing it that way. And then, if they detect that there's an issue, patient says I'm not doing well, if there are symptoms, then they'll bring them in in order to do it.

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 pretreatment or infusions.

It works really well. But they have to get to that step of making a treatment change.

Peter, it's Matt. Just to build off of Rob's point, we continue to see and are pleased that we see month over month increase in adoption despite the challenges with COVID.

And I think that's very much reflective of the broad nature of the label and the impression that physicians are having in the context of how they can use the drug, which reflects not only the third line and later use that Rob articulated, but even the opportunity now that's presenting itself in second line where we've observed prescribing as well.

How much visibility do you have? How much of this is it blocked because of kind of third party and then do you feel like you have enough data to get comfortable about what 4Q could look like internally at least?

The vast majority of the data go – or the prescriptions are going through the specialty distributors. So, at the forefront of that, we don't have the availability or visibility into where these scripts are going.

So, what we'll be doing is actually following those through patient claims databases. Those lag, essentially, about two months or so, which is why qualitatively 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 databases come through and we have the ability to see exactly where they were.

Just a final question around that. With this kind of dynamic you've seen with new patient starts from COVID, should we kind of look at 3Q as kind of a new base to grow from or is it still uncertain?

3Q is a base to grow from in the first place because it's the first quarter of launch. So, we really didn't 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 COVID has presented 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 COVID get better, as physicians say, I need to see these patients and patients demands to go in. One of the other things that we're doing, Peter, is we're directly going to patients now with educational programs to help them understand they can't stay away from the physician office.

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 happens even though there are guidelines [indiscernible] guidelines that came out that talked about being more prudent with indolent lymphomas, many physicians now are starting to say, we can't do that anymore, we have to see these patients. And so, we think that our ability to continue to access these physicians is important even with COVID.

We're doing everything we can to make sure we can access them. But I do think that we see improvement coming as the COVID pandemic starts to have less of an impact because these patients just need to be seen.

And we're seeing that in the new prescriptions as well.

A couple of questions. Number one, it seems like 60% of accounts have prescribed TAZVERIK for the first tier.

What about the second tier? Is it that these are very small practices that just don't have a lot of patients?

I don't know if you can share some of those stats in that tier.

I'll start. First of all, I'll explain what the tiers are and then Matt can go into a bit more detail.

Tier one and tier two together, when you take them combined, it's probably around 800 accounts. It's a large number of accounts.

But these are accounts – our tiering is based on the volume of FL patients that they actually see. And so, when our access is 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 patients.

So, we feel good that we've 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 let Matt explain more about the tiers and answer your question directly.

Rob's right. Certainly, with regard to the success we've had thus far, we're focusing really in the top level prescribers.

We've seen adoption in both 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'll be closely monitoring that as we go forward into the fourth quarter and into 2021.

Is tier two sort of in the 30%? Is it sort of half of tier one?

Any sort of hint?

Yeah. We're still tracking that performance in all of the accounts that we're calling on at the moment, but certainly we've seen adoption across all the tiers, with the bolus [ph] really being in that tier one setting.

You have coverage for about 150 million lives. Obviously, it's about half the country.

Is this sort of more on the Medicare and supplemental? Is it sort of more senior denominated?

Or what's the plans to kind of expand that coverage?

We've been very pleased with the coverage to date, as Rob pointed out in his comments, over 50 plans covering and writing policies for TAZVERIK for FL. As you know, Yaron, the coverage for FL and the population is a more Medicare based population.

But we've been successful in implementing these policies. We believe that's very much consistent with 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 we're continuing to be very pleased with. And we just continue to move down that path with the payer community between now and the end of the year.

A metric that we're tracking on – and if you'll recall, the epithelioid sarcoma launched – by six months in, we had 90% of coverage of all plans. Those lives were covered – we're metric-ing something very similar for follicular lymphoma that we would have approximately 90% of lives that would be covered in around six months or so after.

But if they don't have a published policy, it doesn't mean they're not covering TAZVERIK. Those plans that don't have a published policy, most of them have interim plans in place that allow for coverage for TAZVERIK.

And because of that, we're really not seeing denials of claims for FL, whether it's a plan that's published their policy or one that's still in awareness.

Shefali, just for you, metastatic prostate cancer, it sounds like we're going to have data from the Phase Ib/II run-in safety data next year. Is it potentially at ASCO GU?

And is there going to be efficacy in that look? Thank you.

For the castrate resistant prostate cancer study, we've been very pleased with – actually, a number of things on this. We've been pleased with the rate of enrollment despite COVID.

We've never seen a slowdown in enrollment in the study. There's been a high degree of interest by the physicians who've been a part of it.

We've completed enrollment all the way up to the 800 milligram dose. As I said in my opening remarks, we've not seen any dose limiting toxicities with either enzalutamide or abiraterone.

And based on that safety result 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 could see both the safety and the activity that we've observed so far. But we've not talked about those numbers because we actually still have patients actively on treatment.

Two from please. The first one has to do with the existing treatment paradigm for FL.

I think one thing we've heard consistently from the KOLs is classed FL as an indolent disease, and then many patients are indolent and their willingness to seek and 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 FL opportunity could remain somewhat elusive until the drug can get earlier treatment stages of the disease? And then, I just have one about the label.

We're hearing that most centers, especially in the community, don't have standalone EZH2 testing and most doctors don't know who's EZH2 positive in their practice. How long do you think it will take to implement standalone testing in the communities as a treatment paradigm?

It's a good question. I'll field the first and then I'll let Matt answer the second question with regards to testing.

Your point about some of these patients, you're right, in fact, we've 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, this isn't physician reports, physician perception, through chart audits. It's 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 their contraindicated to.

And so, at every stage, about 10% of patients come off the drug and essentially been sitting on the sidelines. And so, we think that that is an opportunity for TAZVERIK.

I launched like Zytiga in the prostate cancer market. We saw the exact same thing happen there.

Many men had decided they didn't want another round of chemotherapy. They came off.

Many of them went to hospice and they were choosing no treatment until abiraterone came along and enzalutamide. It actually expanded the market.

So, we think that that potential exists here as well and fit the profile of TAZVERIK well suited to them because it's oral, they can take it at home, it's safe. It's one that doesn't require a lot of monitoring and going back to the physician.

But I think this is an opportunity we believe that will have more potential to tap into after we get through this COVID pandemic. It's for patients who already aren't coming in to see their physicians and they have active disease.

These patients are likely not seeing their physicians as 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 TAZVERIK is ideally suited for those patients.

And, Matt, I'll let you address the question on testing.

With regard to testing, we continue to hear from the physician community, from our field based teams as well as our own research that the test is not a barrier to use at all, given the broad nature of the label. As physicians are considering TAZVERIK, if they are to test, they'll test their patients to help just effectively manage 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, for those who wish to test, they've been able to test at the local level, albeit perhaps in their academic centers or in local labs, and those have 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 that have prescribed the drug have actually been tested?

Yeah, that's something that still we're tracking very closely. And when we have a greater level of granularity around that with more quantitative measures, we'll be sharing that.

Hey, thanks for taking my question and going into the launch in detail. One question I have, is there any potential to change that doctors' viewpoint that they need to see the patient and examine him or her before treating TAZVERIK?

Let's say, in a community practice where one physician prescribes it to a patient, could his colleague see the results and then forgo an examination or is this really necessary for all patients to get on a script? I understand that it would be, but I'm curious if there's any leeway there going forward with more physician experience.

Thanks.

It's a really great question and it's hard to speculate on whether that would change. I do expect that a big part of – just based on what you said, it's physician experience.

So, on top of everything else that we talked about with the dynamics, oftentimes, when physicians aren't seeing their patients, writing something new that they're unfamiliar with and they're not accustomed to what might happen is just one additional element to think about for a 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, then they're willing to do – they're willing to use TAZVERIK without seeing the patient. But I don't think it even has as much to do with the drug itself.

It has to do with knowing where their patient is and how they're doing. And so, I've asked this question – and again, this is early, so 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 use TAZVERIK 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 examine 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 their other health status before deciding which treatment to give them.

I think one of the things that physicians actually are doing now, as Rob said, is they are reaching out to patients, they are trying to help them understand that there is need of treatment. Initially, when COVID hit, there was a big – people didn't know how to react and I think people are encouraging physicians and encouraging patients to come.

However, I think we just have to remember that this is indolent cancer. Patients, unless they're symptomatic – it's very different than an aggressive cancer.

It's just hard for them to get them to the clinic.

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 day, and we'll talk again soon. Take care.