Q1 2020 Earnings Call

Today's conference is scheduled to begin shortly please continue to standby. Thank you for your patience.

[music].

At this time, all participants ARNA listen only mode.

There will be a question answer session. After the prepared remarks.

Be advised this call is being recorded at Epizymes request.

I would now like to turn the call Liberty when they should Davis you may begin.

Thank you and good morning.

Earlier today, we issued a press release outlining recent progress in our first quarter 2020 financial results, which can be found that epizyme dot com.

On the call with me are dropping is more CEO.

Roth Chief strategy and business Officer, Dr., Shi volley Agawam, Chief Medical Officer, and Pallets Embassy Chief Financial Officer will join us for acuity pressure.

Today's discussion will include forward looking statements related to Epizymes 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 SBC filing.

These forward looking statements represent our views as of this call it 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 her to Rob Rob.

Thank you Alicia and thank you all for joining us today.

We started out the first quarter. Its 2020 very strong with significant progress on all of our corporate objective.

Particularly important given the challenges in our industry the stage the mid October 19 pandemic.

It up a diamond dedication is first and foremost to take your patience.

Health care teams, who provide their care to our employees.

So the communities, where we live in work.

On behalf of the entire organization I would like to extend our sincerest gratitude to the treatment centers medical professional caregivers and all of those on the front line working to keep us say.

Their commitment is truly an inspiration.

Despite the many uncertainties that have been created by the spending we know that people with cancer and other serious diseases are also still in need of new treatment options.

And we remain focused on maximizing the clinical and commercial potential of pets, Eric further strengthening our ability to impact patients lives and create long term value.

Last quarter, we activated business continuity plans that were designed to allow us to maintain our momentum commercializing South American advancing our clinical program and our early pipeline.

Minimizing disruption to our business and ensuring the safety and well being of our team and their families and our collaborators.

We've not lost sight of our mission.

We continue to evaluate the situation on an ongoing basis assessing the many uncertainties and potential impact this could have on our business.

And we will adjust our plans accordingly.

In early March we shifted the entire company to a remote operating model, except for a small number of a central lab facilities personnel.

We've been working on rotation to minimize time in the office and away from home, while keeping critical activities movie.

Our team safe and well utilizing the mini virtual methods available to them.

They connected and focus on our core objectives for the year.

This is an important your frac design.

With a number of transformative milestones.

These were led of course by our successful transition into a fully integrated pharmaceutical company in January following the accelerated approval that's had mirror.

For the treatment of adult and pediatric patients age 16 or older with metastatic or locally advanced separately on sarcoma.

This approval it has very except first and only after you get your food treatment specifically indicated perhaps.

Patients.

And the first and only approved beating each two inhibitor on the market.

It's still early in our yes launch and we're pleased that had their commercial performance so far.

Within a week of approval.

Christians are being filled.

Throughout February and March we saw steady traction with physicians incorporating had very into their treatment practices.

We also saw an increase in inbound questions to our medical affairs hotline and request through our Epizyme out patient support program.

Our medical Science liaison started in the field last August.

And our educational efforts, leading up to and immediately following the launch.

I want us to reach all key treatment centers prior to the cobot 19 pandemic fully unfolding here in the U.S.

Our field sales organization continues to do their work.

Using innovative remote engagement methods to reach and serve our customers.

This is complemented by other virtual personal and non personal approaches.

Design already built into our launch plan.

Overall, because it 19 impact on new and refill prescriptions among the broad oncology community appears to be modest so far.

Given that some patients have been restricted to their homes based on shelter at home policies.

Or have had limited access to academic sites in other treatment centers.

Importantly.

Barrick has an oral outpatient medicine.

And our commercial infrastructure you utilize the specialty pharmacy distribution network that delivers had very directly to a patient's home.

Helping to eliminate the need for additional visits to their physician or to a hospital to receive treatment.

We've been successful over the months since launch securing coverage for CAD, Derek among targeted health plan.

And our commitment is to ensure that all eligible patients have access and during the last several weeks. We have continued to see both new prescriptions and retails for patients already on Tetbury.

In addition to executing our yes program.

Your quickly approaching the potential second approval for test, Derek which would expand its label into an additional indication and a larger patient population, but then just six months from our initial approval.

Our supplemental Indy acreage has derek for the treatment of relapse refractory Follicular lymphoma patients.

I've received at least two prior systemic therapies is under priority review with the FDA.

We're working closely with the agency.

And we're well underway with our commercial expansion activity to ensure launch readiness ahead of our June 18th could do for targeted.

This will allow us to quickly make treating physicians aware of had very quite approval NFL when it when it occurs.

I Rehfeldt commercial team has been hired and training of our field based employees is complete.

In preparation for launch we have conducted extensive market research among hundreds of community and academic oncologist.

Well I understand how it's had bearing would be used and adopted in the third line FL setting.

We have consistently heard that there isn't a standard approach to treating relapse refractory FL patients and the current treatment option or less than ideal.

Duration of response continues to come up as an important consideration among physician, what's your thinking that cell therapy.

To provide long lasting remission for their patients.

However, toxicities with the currently available therapies remain an issue and many patients withdraw from here as a result.

This feedback speaks to the unmet need in this patient population that the opportunity for well tolerated product with a meaningful and durable efficacy.

Importantly, the feedback also tells us that physician, leaving the differentiated safety profile of had very and the demonstrated activity in both easy H.T. mutation and well take the age to Bethel populations supporting their intended use what's available.

We recently conducted a virtual FL advisory board meeting with about a dozen community an academic physicians, who represent some of the top and college in lymphoma centers in the U.S., which reinforce all of these points.

Based on this collective input we believe has very would be well positioned at the new treatment option relapsed refractory FL patients and we are confident and its potential to satisfy their unmet needs.

We've also been at RFL launch plans to include a variety of selling a such as either personally or virtually.

Positions in key oncology and academic centers as well as non personal promotion through web channels, social media and other digital forums.

We will continue to assess the landscape and we'll adjust our commercial it commercialization efforts at needed.

But we expect to be fully prepared to execute this launch.

Our confirmatory studies for test Viracon, but yes NFL.

Our already underway as well as our combination trial in castration resistant prostate cancer.

Each of these studies is currently enrolling patients into the safety run enforced trials, which require only a small number of patients this year.

We're working to open additional side, but we can complete enrollment as quickly as possible.

And we're engaging with our study investigators for virtual site initiation and trial monitoring.

We continue to expect to complete let's take your running portions for these important trial. This year and then move directly into the efficacy expansion stage.

We also have a number of investigator sponsored trial to evaluate hasn't met OSAT and additional combinations and treatment lives for FL, which are being finalized or are already open for enrollment.

In addition, we are preparing for multiple new studies that have the medicine hat in additional indications and combinations.

These are strategically important to our ability to create value of patients and for shareholders.

Finally, we are in a strong financial position.

We ended the first quarter, approximately 376 million in cash cash equivalents in marketable securities.

We recorded 1.3 million in net sales for test Derek and yes from the first two months of commercialization.

Which is in line with consensus for Tetbury performance.

As a reminder, our collaboration revenues art evenly divided quarter by quarter, but are based on achievement of specific milestones.

Our financial guidance, therefore remain unchanged and we stand well capitalized to fund our current operating plan.

Into at least Twentytwenty too.

In closing, we started 2020 with an ambitious plan, but the company.

And we have not taken out right off of executing our goals for Tetbury.

And advancing our research efforts.

Now more than ever it's critical that we'd be flexible and at the same time be resilient.

We built a robust business continuity plan in order to adapt our business and how we operate as necessary.

We have a highly differentiated commercial stage product and have very.

With the potential to treat a range of additional cancers, including killed lymphoma.

And we have a number of encouraging early programs in the pipeline we continue to pursue.

We'll continue to update you on our progress as the year continues virtually for now.

And look forward to the next opportunity to see you face to face.

Thank you all for joining us and we'll now open the line for human error.

Ladies and gentlemen to ask a question. Please press Star then one on your Touchtone telephone to withdraw your question press. The pound key again that is star then one I would like to ask a question at this time.

Our first question comes from Mohit Bansal with Citigroup. Your line is now open.

Great. Thanks for taking my question Congrats on all the progress.

Thank you so it can help us Uh huh.

Just quick question housing this I understand the dynamics of the launch so far.

Could you talk a little bit about.

Would you go a little bit about bad.

Who is the early adopter of I acknowledge that academic centers or community and how easy or difficult. It is to convince doctors and patients at this point given the koby didn't but.

Due to move patient to decide to take now.

Certainly.

Let the Senate my opening remarks, I'll start and then I'll ask Matt lots to comment specifically on your question I think first of all we've been very impressed with the launch so far.

Sales that we booked based on two months of sales our ability to execute being able to ship drug and seeing the first prescriptions come in in just the first week following approval.

I'll have been great things.

I'll ask Matt to speak about a bit more about the specific question you raised as to who using it and how are they using it so Matt let me kick it over to you.

Sure Good morning, Mohit, Thanks for the question.

You know we've observed.

With regard to the S launch to our expectation that the academic centers really being the place where the majority of prescriptions have been falling as it relates to EPS affiliates or call. My as a reminder, when patients are diagnosed with this disease. They often go to a multi disciplinary treatment center or academic center there or.

Proximately 60, these centers around the United States that uniquely have seen this population of patients and so.

Is that.

Utilization, thus far has proportionately been in those centers as we would have expected that to occur.

Very helpful and then if I can take us.

Have a follow up so moving to a federal NOL.

Oh, it was markedly different from yes.

Correct. It is more a comedian do when.

Okay. So what you can do differently there to make sure that Cooley doesn't mean that the launch preparation or or or how do you hope that drew approaching thank you.

Sure So you're absolutely right.

In Follicular lymphoma, the the overwhelming majority of patients up to 80% of those patients are actually observed in the community based setting.

As compared to he asked where the majority of patients go through these academic centers with regard to the launch planning for.

FL as we've spoken in the past our plan, it's always been to leverage the insights in the infrastructure from the E.S. grouping to then quickly expands to FL and our approach with regard to Follicular lymphoma.

He has been thoughtfully considered in the context of how we would engage either direct promotional engagement with our sales organization.

Producing other direct engagements with regard to promotional speaker programs or other matters in that regard and now and in light of things with cobot. We're now starting to think about pivoting those two more virtual engagements. So our ability to reach the physician community based on the talented organization that we've hired the relationships that they have in the community.

He will be leverage just a bit differently, but not terribly inconsistent with our original thinking which is will speak to the physician community into health care prescribers in their practice, but we'll engage in that and that type of engagement to virtual methods until parts of the country stature riocan.

Hi, so thank you very much.

Our next question comes from Michael Yee with Jefferies. Your line is now open.

Thank you good morning, guys I appreciate the update.

My question is a follow up in relation to thinking about p. pending approval Follicular and the question is.

You know how do you think about the feedback and what what kind of feedback did you get from your virtual meeting other dashing clean kill Alice.

To the trajectory of uptake.

When she gets approved.

In that community setting and despite coven. The reason I ask because you look at some of the other shales comps in Follicular, which I think some of the consensus has modeled after like Zydelig add guiding to get to like 35 40 million show given that comp how do you think about the utilization and a covenant fire.

Men.

Maybe talk to that and whether that is a reasonable appreciate it.

Certainly that would you like to start and then I'll add to your.

Your response.

Sure absolutely so good morning, Mike.

With regard to uptake in the feedback that we continue to receive with regard to the profile of passive Eric.

We've we've stopped the perspective with many physicians, particularly over the last six months, where we've had significant level of engagements in interviews.

With both the community based in academic based.

Groups.

The feedback is very consistent no standard of care as Rob mentioned on the call currently available choices provide limited benefit and these prescribers are looking for something new particularly something that's safe.

And has the the benefits of durable and meaningful remission.

So with regard to that we believe that cause Barrick is very well positioned certainly as an oil medicine were given the cobot situation. We believe that test barrick fits in quite nicely with regard to that dynamic as well with regard to your question with regard to say delegates is a comp keep in mind that one's idled was approved.

It was actually improved for two indications of CLL indication as well so it's difficult to parse out expectations around their FL performance. We believed that the attributes of tests Barrick with regard to.

What what this molecule will provide will be meaningful and position based on their feedback are looking forward to it to arrive in the market.

Can I ask a follow up which is you get the anticipate.

Anticipation or sense based on talking to them that there's patients identified or some sort of pent up demand since the drug already out there and they should be awareness.

Well, there's certainly that the level of awareness has been increasing overtime certainly with I think quite quite frankly, starting back with our muscles in the field in August the unanimous ODAC that dish, calling her team facilitated for US and then you know with regard to our performance with yes, we've certainly seen.

Interest in FL that continues despite the predominant performance in the us with regard to prescription use.

So we feel like we're going to be in a very strong position to have uptake come out in a meaningful way.

Okay. Thank you Mike I'll, just add a couple of things a couple I'll add a couple of things to our to match response I think they're probably also important.

Our anticipation is that.

Both had asked the question about where the yes use has come from its been largely the academic centers and we expected that's where those patients would go it's probably also where access has been the most limited we expect that will have.

More open access and probably earlier stage begin to open in the community practices compared to the academic centers. So I think that will likely want to see how this plays out but my expectation is that will allow us access into the community office is probably earlier than some of the academic centers, where many of the patients are treated I think one of the other things playing in our favor is.

We've been doing the work since the launch to gain access with our payers and so we're now on those health plan. That's been secured for most of the targeted players and we don't have to go through that process within the uptake for the indication. Once have felt was approved and then the final thing I would say with regards to how we see that's impacting so the law.

Once we close the study all of the prescription data, which I'm sure you do as well.

It seems that the the impact on oncology prescriptions, particularly targeted oncology prescriptions and worlds in particular have been less impacted than some of the others that require patience to come in for their treatment or for their infusion.

And so we've seen the just across the board not looking at Tetbury, just in general those oral and targeted therapies.

For these oncology patients seem to not have been impacted nearly so significantly. So again, we don't we think that just because it has barrick is an oral product it can be delivered and taken at home.

Along with all of the other attributes that I went through in that went through that Weve found as we've talked about the actual attributes of has Derek and in the market research. We think we'll be very favorable as we.

Roll this out because the approval by the FDA.

Appreciate it thanks, Rob appreciate kept it.

Our next question comes from David Lim with with Morgan Stanley. Your line is now open.

Thank you very much for taking my question when you look at the.

I mean trials for our squared and our child.

How do you see.

Given current environment recruiting.

For those trials and monitoring going forward from studies and how you might see the impact of when I guess data might be presented interim analyses might be.

Certainly David So let me comment at a high level and then I'll, maybe turn it over to should follow just talk about some specific things that we've been doing.

Like our commercial efforts that Matt talked about we essentially moved all of our efforts on the clinical side too.

Ability to monitor studies enroll new sites and do all of those things virtually so that work has not stopped it's just happening in a different way further confirmatory studies that you asked about remember that the number of patients we actually need to enroll this year is actually fairly small because their safety runs that been informed that dosing for the larger effort.

See portion of the study.

What we previously guided is that we would complete the safety running this year and make the transition.

So we expect that based on the numbers of patients that we need to do that will still be able to hit that objective for year to have the safety running is complete and be able to make the transition to the efficacy expansion.

Perhaps if only talk a bit more about just how we're doing that in some of the specific work. Her team has done to ensure we can engage with the sites around both sides start as well as monitoring of ongoing patients.

Yes. Thank you. So this is your folly good money so as Rob said most of these studies the two Clos and make these studies are safety studies and data flash.

They small numbers this year.

We have shifted to a watch whale fronting is conducting these studies.

You know just to ensure that the patients can be and goal and also monitor bake into what ongoing on the trial.

Our goal is to get all basically use different methods of monitoring, but it's what children are using.

Leveraging travnik does took and that's 50 labs and proceeded as you're allowing patients to do local lots and the logical scans at the places where they are self traveling but that means that does.

Yes, and also being the most with its a policy does best feasible. So that you know they can get some with access to that drops what the prototype. Additionally, what to get also doing is opening additional sites. So that we can compete didn't want to my desk with you as possible and engaging with US study investigators collect just like any situation then tried monitoring.

And as I as Ralph mentioned, because these are mainly safety studies, we expect to complete the safety studies bullet, but yes, NFL dustier, along with prostate and hopefully less out you know maybe because of that eat up before the timing, but not commit to the presentation at this time.

Thank you very much.

Our next question comes from Yaron Werber with Cowen Your line is now open.

Hey, good morning.

Well I've a couple of questions about the ongoing yes experience, maybe first and I apologize if I missed that earlier the so we calculated about 43 patients.

Just based on looking looking at the two first month to sales.

But that's not assuming any gross can that discounts and my first question is can you give us a little bit of it sounds kind of are we thinking about a 50% gross than a discount maybe 10% is that reasonable then I have a follow up.

Oh, you're wrong. This is Rob so I think what we guided at the beginning of the year probably hasn't changed much in that is that we would expect the gross to net you're roughly between 10 and 15%.

Over the first year.

Okay, all right because that's reasonable and then the initial patient experience is it mostly patients coming from clinical studies.

Or you actually you bought into commercial already knew new patients.

No most of the patients in the clinical study because remember we had long term follow up on most of those patients many of them had already.

Come off of therapy.

So these are patients that we are mostly sourcing from the open mark from commercial from the open market. These are not clinical trial patients that were converting over.

Okay, and given anything you know obviously, there's a lot of initial pent up demand and then you sort of go into a new identification then.

You know any sense.

How many patients are currently.

Diagnose tore eligible for therapy and has your thinking changed so we can all bottom to accurately.

Because we would expect vernacular going up initial uptake and then probably a slowdown.

Yes, Matt do you Wanna would you like to take that question.

Sure. Good morning, So I mean, the new we've seen certainly newly diagnosed patients come in as Rob mentioned with regard to do scripts that has continued through the first quarter and in fact, those new scripts have now transitioned into retail prescriptions as well so.

We continue to see the right type of performance with regard to test Barrick and the up affiliate sarcoma community and we would anticipate that continuing into the second quarter and beyond.

[noise] the other thing I would say about that number you're wrong I think it's hard to keep in mind oftentimes, if you're launching a drug with a large indication over a large population you'll see a lot of stocking that occurs.

Very early on the drug its first approved and so you have to tease out stocking from actual demand in our case. This is almost all demand, but just being an ultra rare type of tumor.

We don't see pharmacies really stocking the drug it's more of an on demand.

Yes.

Okay, and what what's the what's the legs from from I would say diagnosis to actually coming on therapy.

Are they requiring the I and I data.

Is that what was that sort of typically already available. Thank you.

Sure. So further.

For the use of test Barrick, there is no labeling requirements or diagnosis of an IDE one negativity as you know.

Most patients who have empathy leeway sarcoma have I and I when loss over 90% of patients who have that there's not a specific requirement for that in the label.

In order to use test, Eric and we're seeing some utilization another one negative tumors that for the most part of the sales that were seeing or in patients who are who have diagnosed with really good sarcoma.

Okay terrific and then maybe just a final question in terms of Follicular from your AD Board.

How do you do you see.

The initial demand going to be isn't patients, who or third line to fill prior therapies and have been.

So the follicular identified for legal patients for a while a good bit off therapy for awhile and that's sort of the initial.

Patient, who is going to roll into this drug wars, they're going to be patients who are recently relapse refractory and it's going to be a switch from let's say second let failure at the third line.

Just given the amount of patients out there. Thank you.

Certainly good question, Matt I'll, let you talked a bit about experience we have both from our market research as well as from the advisory Board as to where you think has barrick will be used.

Hey, Rob so.

The feedback from the Advisory Board that we recently conducted as well as the voluminous market research that we've executed continue to provide the same consistent level of feedback that physicians are encouraging enthusiastic about has VERYX profile, particularly the activity that's been observed the duration of its activity as well as the safe.

He profile that's associated with molecule.

With regard to where we see patients coming from.

It offer that it did in the near term, we would certainly expect that patients who have progressed on two or more prior therapies consistent with the label would be eligible for tests VERYX. So we certainly expect that population of patients come in but as we've talked about in the past, we certainly had a hypothesis.

And thought process around given some of the challenges of the existing treatment regimens that some patients in fact will choose to opt out of therapy, and we believe that a new molecule with a better differentiated safety profile may encourage them to come back in so those patients that have perhaps had a challenging experience with one of their prior treatments certainly.

With has VERYX approval could come back into the market and could come back in for treatment for a brand like this one.

Great. Thank you.

Our next question comes from Leland Gershell with Oppenheimer. Your line is now open.

Hey, good morning, Thanks for taking my questions just wanted to ask a bit further on the high on the market research that youve.

Recently.

And also your AD Board comments, just as we think about uptake into those with easy it's true that can be mutations versus wild type, maybe if you could share some more color as to what you think that trajectory, maybe and I know if any.

Active coated.

Play given that that even though your label May.

For the broad label, that's ignostic to mutation.

Physicians, who.

Tests.

Oh thanks.

Okay Matt.

Sure So with regard to maybe that maybe I'll start with the cobot considerations first I mean as an oral treatment certainly test Barrick we believe.

Given the circumstances.

It certainly well suited to manage the situation that the health care community is facing with regard to the koby crisis and the fact that we've built a very thoughtful distribution plan with specialty pharmacy, we believe that the ease in patients receiving this therapy.

Is that has been established and again for physicians, who wish to use test American FL, albeit a very fluid channel for them to do so with regard to the feedback.

On our research and our advisory Board, it's it's been remarkably consistent to be.

Candid.

The acknowledgment that Theres really no standard care for patients living with relapse or refractory disease that the current therapies do provide limited benefit.

And that there is a desire for a new class and a new option to address these patients consistently presents itself with regard to our research and the feedback from both our academic and community advisors that we spoke with.

With regard to uptake in either mutation only mutation patients as well as wild type patients, we've yet to see a fundamentally disproportionate.

Level of interest vis-a-vis, one group, having more use versus another at this point that we see that the profile test well for patients with both wild type and mutation and we would expect utilization in both segments.

I think the important thing that from the Cleveland is that just questions come up for us before and what we see in the research that we've just done is there's not a strong desire among physicians to test for easy age to it is available to they'll today. They can test through foundation medicine, many institutions have their own.

They have testing.

Even without the diagnostic that was used in our clinical study, but I think that is right. We were seeing that there isn't a strong desire to test I think they looked at the profile as one it's all the issues some of the issue that I talked about the unmet need they need sustainable remissions in these patients who've been through one or two prior ounces therapy, many of which have toxicities.

And they can't stay on the drug and so therefore, they don't have long lasting remissions, that's what they're looking for and the durability of benefit in our patience is the same whether it's a patient with the mutation or patient who has filed type PVH to the response rates are a bit different.

But once a patient response.

The response looks the same the durability of response is very similar and even in those patients in our study to who were wild type who didn't have an objective response keep in mind that about 70% of those patients did have reduction in their tumor volume. So they're benefiting that may just never get to the threshold of having an objective response I think when physician fee that data in total.

I'd.

They they see that it meets the unmet need that I've talked about in my opening remarks, which is a drug that is safe tolerable patient can stay on it and provides a durable long lasting benefits.

Thanks, That's helpful. And then just to ask you know given the given the very favorable safety profile of a because her.

What would you expect.

Good.

Patients, who maybe on let's say a second line regimen that does have toxicities is a lot of these alternative options have with simply switch out and go to 'cause herc irrespective of the efficacy side.

See regimen that they are on in other words not wait for a formal efficacy failure, but move to another region, that's maybe sort of take.

Yeah, I think it's instructive and I'll ask Matt speak to it as well, but I think the research that Matt references instructive to see that we'd have a we see in the research we did with patients and with the physicians treat them. There was a proportionate patients who just come off therapy and they'd go off therapy completely mainly related to toxicities are adverse events and they don't.

When it come back on the treatments that are currently available. So we believe that type of the patient would be the good candidates.

And given particularly in the patients who have an easy HQ mutation in the single agent activity that we're seeing a close to 70%. We believe that's a reasonable thing if they whatever reason have either failed on a second line therapy or we're not able to tolerate that and again our research shows that there are some of those people.

Sadly don't come on to anything right now and we think this is the indeed, we can address with test there, Matt I wonder if you'd like that anything further.

No that was those wells that have been I certainly agree it'd be this the research has been like dust with regard to that regard about patients coming.

Off of therapy, because of these types of challenges and tolerability challenges so.

Your point given that exists the profile of tests vary.

This is the potential for them to come back on to treatment and do well and do well.

In a safe and manageable manner.

Great then and it just one more if I may add.

Have you.

The drug approved for yes, and then the data out there.

Phil if you could you quantify maybe any level of interest she has gotten from physicians to get hold of the drug for use in flux in their patients that have the.

Thanks.

Yes, we have from the beginning of the we described our last call that one of the first prescriptions that came in was actually for a patient with relapse refractory liquor lymphoma.

We continue to see some up some prescriptions and indications that were not if appealing sarcoma. Some of those had been FL. Some of those have been patients who have other I and I went negative tumors other stark homeless.

For the most part the predominant use that we've seen has been for patients who have ever feel really took home.

Terrific. Thanks, very much guys.

As a reminder, ladies and gentlemen, if you'd like to ask a question at this time that Star then one.

Our next question comes from Peter Lawson with Barclays. Your line is now open.

Hi, Rob I'm, just to kind of I guess your follow up question around potential use.

Well use you seem to get any details around.

One's a few so you'll see into this medicine spin you slow agent convoy agent.

Any other color around Oh.

Off label use which really picked shipments you'll see.

Yes, well I'll ask if Matt can speak a bit more to what we're seeing and you have to field sarcoma use Matt.

Sure Good morning, Peter the majority.

Utilization, thus far with regard to test Barrick and yes has been Tom and only been associated with monotherapy use.

And then with regard to your question around other I and I have one malignancies, there have been a few.

And I won sarcoma does that have appeared.

To our understanding.

Is that changed in any way in April that trend and that it sounds like the majority of scripts coming from.

Yes.

Yeah, I mean, the performance with regard to what we're seeing through the month of April now that we finished the month that hasn't really terribly change much with regard to prescription utilization as Rob mentioned earlier, you still see the predominant.

Number of patients being yes patients and these are both new patients coming onto the therapy, but certainly patients that were prescribed the drug in February and now starting to get the refills and starting to fix you know continue on therapy.

Great ticket was it just quick question, but it seems that it was a change in opex guidance going from GAAP to non-GAAP. Just if you can pull through that instead of layoffs and recognition.

Change.

So I think it was question was to tell a bad it's I don't hear him. He may have dropped off so I'll I'll answer the question.

There wasn't a change Peter we actually did you go back to the Q4 results we reported both both GAAP and non-GAAP.

We're highlighting the gap in this case, because we thought the just the cash expenses that affect the cash runway that people are most interested in we did pay the milestone payment to eight side or the approval the $25 million milestones that however was covered.

By the Royal by the Farmacon loan instruments.

That we used to cover that so from a cash point of view it doesn't affect our cash it doesn't affect the non-GAAP. So thats a non-GAAP expense covered by the royalty.

Farmacon bone instrument that will be the same we'll have another onetime it's like that coming up if we're successful.

With our approval.

June four Follicular lymphoma, we'll have another $25 million milestone we go.

It will be covered by the farmacon loan as well.

We report, but probably not a theme we share, but GAAP and non-GAAP.

Hi, Good morning, everyone. Just follow I was just use that word for your into real but I think you on sort of perfectly. The question I don't know, it's Dave and now the full up happy to answer.

That's great thanks to clarification.

Chris.

I'm showing no further questions in queue at this time I'd like to turn the call back to Mr. based Moore for closing remarks.

Okay. Thank you so much and thanks to all of your joining today. Thanks for your questions.

Look forward to keeping you updated on our activity as the year progresses, and we hope you all have a safe and and healthy day today have a great day take care everyone.

Ladies and gentlemen, this concludes today's conference call. Thank you for participating you may now disconnect.

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