Q4 2019 Earnings Call

Dead dead dead dead.

Hello and welcome to episodes conference call at this time. All participants are in a listen-only mode will be a question-and-answer session after the prepared remarks. Please be advised that this call is being recorded at his request of now like to turn the call over to Alicia Davis. You may begin.

Thank you and good morning this morning. We issued a press release outlining recent progress and our fourth quarter and year-end 2019 Financial results, press release and slides to which will refer can be found on our website at amazon.com.

On the call today is Rob Bazemore CEO, Matt Ross Chief strategy and business officer. Dr. Shefali Agarwal chief medical officer and Chief Financial Officer of 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 box to the very important factor including those described in the risk factors section of our most recent form 10-q, and other SEC filings the forward-looking statements represent our views as of this call may 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 rub.

Thank you all for joining us today.

20/20 is already off to an incredible start. We have successfully transitioned into a fully integrated biopharmaceutical company commercializing our first product in the US and look forward to a potential second approval later this year.

Our top priority is to maximize the clinical and Commercial potential of test Eric the further strengthen our ability to create long-term value.

As Marik is now the first and only FDA-approved treatment specifically indicated for epithelioid sarcoma patience and the first and only approved ezh2 inhibitor in the Market within a month approval you were shipping drugs to patients. And since then we've seen verification of benefits and calls to epizyme now, not only for patients with but also for patients with other Ian I wave of tumors and with follicular lymphoma or FL

Speaks to the unmet need in these diseases and the overall favorable profile of tests as a new and ecology treatment.

we have

High expectations for the launch of pets. For e s and evaluating our execution. We are particularly looking to see rapid adoption of Tesson Ferry across all lines of treatment. I have the conversion as patients who have been identified by physicians into new prescriptions. It's an increase in the number of eligible patients as a result of educational efforts aimed at appropriate diagnosis of the s

are launching e s allowed to build out of a flexible and efficiently size commercial infrastructure. It has established our presence in the oncology field and is now being scaled up to support the potential launch NFL package recent acceptance of our FL India for filing.

a strategically intended we were able to leverage modules from r e s n d a r f l n d a streamlining both the submission and review

Yep. Yeah. Yes Granite has very priority review for patients with relapsed and refractory FL whose disease has progressed following two or more lines of systemic therapy importantly the agency designated our application as a supplemental NDA or snda and granted an earlier than expected Paducah date of June eighteen twenty twenty

Given this timing we intend to build on our commercial experience with the to seamlessly launched has Barak for FL upon approval and to achieve rapid market adoption among patients with relapsed and refractory disease. We've nearly completed rfl commercial expansion as well as our market research activities to understand the treatment landscape in order to optimally positioned as varrick for use these FL patients.

Third line and later approval is only our starting point in FL and we intend to quickly execute our clinical development plans to generate the data needed to support our goal of making tens of Eric available to all FL page in the future.

A confirmatory trial is optimized to establish the benefit of pets in the second line setting and it's open for enrollment the study to evaluate has Barak in the Frontline setting as well. As a number of instigator sponsored trials combining heads. With commonly used agents. Also begin this year provide meaningful data across all treatment lines.

Are you still in our clinical and

Preclinical experience that has a metastat and our extensive knowledge of ezh2 biology. We believe strongly in this potential to treat an even broader range of cancers. Then we have explored to date back about a multiple opportunities for label expansion.

We are working with investigators and academic collaborators to advance a number of clinical studies protest metastatic as a monotherapy and as a combination treatment for other hematological malignancies in solid tumor where we believe it has the opportunity to win.

Today we find ourselves at a key inflection point with a successful transition to a commercial Enterprise and a robust set of activities planned for the year ahead. I am very proud of how far we've come and I'm excited for the future of this company. I'll turn it over to Matt to provide an update on how the test commercial launch is progressing.

Thanks, Rob. I'm delighted to share some early highlights from our commercial launch which should translate well into the larger opportunity of an FL indication. Should we be approved?

All right.

Attention is to make test Barak available to every appropriate patient in the United States when we announced as Barracks approval on January 23rd, we committed to making it available to e s patients within 10 days.

Thanks to our great team effort be completed this ahead of schedule and our first patient received has Eric on February 1st.

In addition has Varick was added to the nccn clinical practice treatment guidelines for soft tissue sarcomas indicating consensus is emerging as Marik is an appropriate treatment option for patients with e s

We are very pleased with this inclusion and in particular the speed at which the nccn expert committee convened and recommended he added to the treatment guidelines.

We estimate that there are about eight hundred patients in the United States diagnosed with e s of which approximately 300 are eligible for test.

It is a

Rare cancer that is not well-known and has often misdiagnosed initially.

Significant part of our commercialization strategy is to help educate Physicians on that. They may provide an accurate diagnosis earlier in the patient's Journey.

Through this effort we expect to gain a greater understanding of the true prevalence of which we believe is larger than the current estimates.

A commercial success in e s is based largely on three key factors supporting test very wide adoption by physicians as the standard of care for their patients reaching all your patience and providing them and their prescribers a positive first experience with the brand and ensuring that patients have seamless access to test of Eric through our epizyme now patient Support Program.

It's early days into the launch and we are pleased with the physician enthusiasm and desire to prescribe has of Eric so far.

Okay.

Design now is fully active and has been facilitating patient access to new test Barak prescriptions.

As we look ahead there are a number of elements to how we will measure our Commercial Success including physician adoption of tests lives covered with no barriers to access and time to prescription filled.

To support these metrics are customer-facing team is making a tremendous effort to generate demand and awareness Fortes very to identify and overcome barriers to treatment finally to collaborate with large community provider networks to build educational Partnerships on disease testing and create awareness of the availability of Tears by Eric.

In addition, we have established relationships with key National and Regional payers and they're striving to ensure formulary access without limitation. We have built a plan designed to ensure that all Specialty Pharmacy patients upon receipt of a prescription for Tesla have their full benefits investigation completed in their prescription filled within five business days.

the design of res commercial launch strategy and the expertise of our team will enable us to quickly pivot also support the commercialization efforts or test in a l

follicular lymphoma is a slow-growing or indolent form of Non-Hodgkin's lymphoma and accounts for twenty to thirty percent of all NHL cases.

It is usually not considered to be curable and patients can live for many years while going through multiple lines of treatment.

Approximately 14000 patients are diagnosed annually in the United States and the overwhelming majority of patients have advanced disease at diagnosis.

How many patients were response to their initial therapy it will usually relapse and the efficacy toxicity trade-offs of different regiments are major clinical issues.

We conservatively estimate that there are ten thousand to twelve thousand patients with relapsed and refractory disease in the United States. Our ultimate intention is to make terrible to all patients starting in the relapse to refractory third line or later setting and then moving into earlier lines of treatment.

We have conducted extent.

Did market research the opinion leaders and community-based practitioners understand their perceptions and treatment decision making process.

SLE patients are typically diagnosed in their mid-sixties once a patient progresses treatment decisions are influenced by their age comorbidities former on previous regimens and their desire to preserve their quality of life.

It's a difficult decision of potentially stopping further treatment and instead burning the palliative care.

The frustration and anxiety patients face are compounded by the limitations with today's available treatments.

It can take something that's been previously prescribed use an off-label agent or consider an improved therapy that requires proactive and intense side effect need you to Black Box warnings.

our insights tell us that patients and Physicians would value and alternative treatment with product attributes that demonstrate that it is efficacious provides durable remissions wage, and it's safe and easy to take offering them New Hope

this is

Is why we believe kazmarek is uniquely positioned for this indication and will be widely and rapidly accepted.

Operationally we have initiated rfl launch Readiness activities to ensure our field-based team is ready well in advance of our producer.

Our sales leadership team is in place and we have completed our hiring of our sales representatives all of whom have significant depth and experience in oncology.

We have an important year ahead and I look forward to sharing more updates as we progress throughout the year.

I'll now turn the call over to shefali to review our broader development efforts for pezzimenti's. Shefali t j e s and the FDA is acceptance for filing of our SLS NDA are incredibly exciting successful execution of both programs is imperative.

What is this is?

Includes the ongoing Global consummated trial in front line as well as the post-marketing commitments.

All of these studies are underway, and we expect to complete the safety portion and move into the efficacy portion of our confirmation study later this year.

For himself because many of the modules in our snda including City but reviewed for yes, they distribute will focus primarily on the clinical efficacy data.

Indication resubmitted is for fishing the relapses or refractory officials who have received at least through Fri lines of systemic therapy.

Lita from our phase two trials that treatment which has resulted in clinical benefit as assessed by both investigators and in the independent review comedy club and has shown to be generally well tolerated in the station population.

In addition to that study. We have multiple investigators process studies planned or underway to further support passwords using the third line or leader setting by combining with commonly used drug treatment, including a limited.

Do you believe that?

The same profile that must have very attractive location and third line settings also make it attractive for patient and earlier settings. We have thoughtfully designed our ongoing Global confirmation to some cats have a square versus placebo, press a square formation in the second line setting.

The study design is supported by data including the clinical benefit demonstrated by Catholic as monotherapy in relax or refractory NFL domestic rationale for combining has been a an option where the preclinical evidence suggesting Synergy between password and developments and the activity of Patrick when combined with our child in our own going to be CL truck in addition. We intend to enroll patients were attracted to the Texan in the first line regiment population in which we have observed activity in our phase two trials.

We have designed the studied include a maintenance therapy state has to study the effects of treatment on extended progression-free survival and have implemented an Adaptive design understand the treatment effect early on to interim assessment. Just a trial based on how that work is performing.

for all these these

We have confidence that this combination and trial optimally position and accessible would support full approval and a label and second line and found it actively screening page in the safety running portion of the trial which we expect to complete this year.

Supporter instant to demonstrate benefit in the Frontline setting we're expanding our trial combined password the dark chop a newly diagnosed high-risk patients who also includes can I help patients?

Beyond DS NFL clinical expansion of Tampa medicine is this year, which we will execute and collaborative efforts.

You know that if he has to place a role in many chances and have conducted a comprehensive analysis to identify patient populations and treatment settings where we believe we can demonstrate benefit which has a month. We see the greatest opportunity all of which are based on strong scientific rationale and the need for new effective and safe treatment options.

the first

And hematological malignancies particularly lymphomas and we sell malignancies such as we'll be CL and see amount because of the role easiest to place in the cell biology.

Regardless of the mutation this cancer cells are governed by easier to expression which enables their growth and proliferation.

Any building easiest to you believe we can inhibit tumor proliferation. He's into entertainment activity as seen in application with wild-type.

The next area of focus is a mutation redefined solid tumors the desk or Doma melanoma and tumor with a Sly Slick alteration or other mutations in these tumors cause a loss of certain proteins are the presence of certain mutations can an abnormal easier to activity or exaggerated dependence on media to it leads to cancer cell growth. In fact easiest do with Tessa medistat. We believe we can inhibit that abnormal function directly to the store in sales to the Natural State.

The third type is solid tumors that are resistant.

Just triple negative breast and ovarian cancer and mesothelioma when Kimo is given DNA becomes damage resulting abnormal overactive easiest to activity which is involved in the transcription reprogramming that leads to chemoresistance and increase cancer cell survival and growth by treating with an easier to inhibit you believe we can recent strikes us to chemotherapy. We also know that it is to play the role in the resistant to parts and appetizers and five millimeters are given his damage to increase easiest to activity and responsiveness Department.

Blocking easier to be 10 minutes. You believe we can also resend sentiment to a part and efficient.

The fourth area for development isn't too much easier to Innovation May augment respond. I mean oncology treatment.

Speak like a data suggests have the best at me and has an immune response by interfering with multiple easier to function in the cell renovating easiest to we can influence life activity in the tumor microenvironment, which gets enabled tumors to be more sensitive or decent-sized immune on qualities help.

Yes.

Lifecycle development of has another side is strategic to the future value creation of time today. We have twelve clinical investigations underway, which include a global multi-center rack. My fees would be two trials evaluating has metastatic in combination and dual demise or ever drawn plus prednisone and chemo patients admitted static castration-resistant prostate cancer off the plan to have an addition for studies up and running this year including the plan combination trial with a pipe and bitter following completion of preclinical work every guide the design of the study and selection of which part of inevitable use

The strong preclinical and clinical data supporting the role easiest to place in all four of these tumor tides, and we believed has a minister has an opportunity to meaningfully address these areas for patience. We look forward to providing an update on these studies as the year progresses.

I know tend to call over to follow to review our financial.

And good morning, everyone earlier today. We issued a press release with both our first quarter and full-year 2019 Financial results. So I will cover just a few highlights Long Island 2019. We utilize a number vehicles to bolster our cash position to ensure we maintain adequate funding to support the full breadth of pathetic opportunities. We have jobs, but also supporting the growth of our pipeline in our organization is included in equity raise a 172 point five million dollars in March of 2019 month followed by funding agreement with royalty Pharma execute in November royalty Pharma conducting due diligence before making an upfront Equity investment 100 million dollars along with our options following these races and with the diligent focused on financial discipline. We start the 2020 Universe from cash position with 381 million in cash dead.

cash equivalents marketable security

As of December 31st 2019 notably. The cash balance does not include additional fifty million dollars pays through the exercise of the equity put on a royalty Pharma executed in general as a result. We started this year with more than 430 million dollars of cash and cash equivalents are the more under separate agreement parmesan advisors an affiliate of royalty Pharma. We established the $17 loan facility with the 3-year interest-only. Intended to fund the for regulatory Milestone both sides. This loan is expandable by up to an additional three hundred million dollars if we receive approval of us very NFL

I need the revenue. We will begin reporting product revenues in the first quarter since as very was approved in January. We recognize twenty three point eight million dollars in collaboration wage 2019, which reflects Milestone payments achieved from growing a single time under our multi-target research collaboration along with the condition of the development Macon, Georgia line for each year. And if you want any bitter which was discovered by a decent hour gap operating expenses for 2019. We're 201 million dollars a month that are in the expenses one hundred thirty two point six million dollars, which included the initiation of our to Global confirmatory trials and early expansion of our title office development program.

Note that this also includes twenty million dollars.

In my extent paid to Asia for the es NFL NBA submissions, which were funded through the loan facility provided by Farm account sg&a expenses for 2019 were 68.3 million dollars which included the build-out of our infrastructure to support the launch and commercialization of that very for the syndication initial expansion prepare for effort commercialization in the US.

As we look ahead we have a master set of activities planning for 2020 which will impact our expenses for the year. We expect gaap operating expenses to be between $300,330. This includes fifty million dollars in Milestone payments to Asia or South America prove a curious and anticipated approval for later this year off importantly the cash component of our operating expenses is expected to meet between 235 and 255 million dollars, which is almost evenly split between Monday and sg&a.

the year-over-year in

Please note in the expenses mainly reflects advancement of our to Global confirmatory trials our post-marketing commitments for years and the greater life cycle expansion of the domestic wage dissipate that several of these artists will be sponsored by investigators or conducted through academic collaboration, which will enable us to partially offset our in the expense while continuing to expand our Tomatoes. Program to maximize its value sg&a expenses in 2020 are expected to increase with the recent launch effort for years and the scale-up of your choice to support anticipated launch in commercialization of prosperity for FL. We anticipate that will also see an increase in our manufacturing expenses as a result of the commercial inventory. They continued clinical drug supply for our ongoing studies.

Real World Finance today with cash and cash equivalents to support our current operating plants in to at least 20 22. This runaway does not include any Milestone that may be achieved through our research partners and Business Development activities for any expansion of the credit facility with pharmica follow which we plan to opportunities to partner bolster our balance sheet cake stand in a great financial position and do not see the need to purchase an equity financing in the foreseeable future it lets us the code back over to drop off. This is a remarkable time for epizyme is we execute on our vision 20/20 is off to a roaring start and we have a number of exciting Milestones this year including to commercial launches of public into distinct indications.

We also have ambitious deliberate expansion plans for has metastatic as we believe strongly in his potential to meaningfully impact a broad range of cancers.

I'm confident in our ability to execute these goals so that we may continue to create meaningful new options for the patience. We strive to serve and meaningful value for our shareholders.

If you all for joining us and we'll now open the line for Q&A.

Thank you to ask a question. You'll need to press star one on your touch-tone telephone to withdraw your question. Press the pound key.

And our first question comes from Bullhead City your line is open.

Great. Thanks for taking my question and congrats on the progress from my side job. You do talk about you kind of divided the market in kind of first-line second-line how the opportunity would increase could you provide a some numbers behind for the 3rd line treatment paid which you'll have the initial label for this particular informa how many patients are we talking about here? And what's your strategy there as well?

No, it's Matt. Thanks for the.

Questions. So as we we shared in the call, our goal, of course is to make Tesla Eric available to all FL patients across all lines of treatment and the first line treatment setting we know that there's roughly fourteen thousand patients that are newly diagnosed each year. And then for those patients that relapse or have refractory disease population is estimated to be between 10 and 12,000 patients with regard to the third line opportunity with specific. Um insights that we're continuing to refine as we go through our research. We think that roughly there's anywhere between roughly about 6,000 patients that we think are reasonable in the context of the third line space which is consistent with the consensus and numbers that are out there right now.

We know that.

10 to 12,000 number that we site on the slide those are patients who move Beyond first-line therapy. We think most of these patients ultimately because this is a non-curable Tunis curable disease motion those patients do eventually move through multiple rounds of therapies as they continue to relapse to the treatments that they're on

Got it, and then in terms of strategy, what are the planets?

So in terms of having this issue on the European strategy, they wanted to just line on the FDA now that we as you know, we have been accepted as an snda the age of 18 June we are engaging in the process engaging the European regulatory authorities to understand our plan. We have conducted many advice reports and also trying to understand the path forward for for Europe off guard and if I may ask one more on the prostate cancer site seems like your competitor for population at least has some data in prostate cancer one that we can learn from there, uh data for your own program as well as how do you have any differences in molecules, which could be dead eventually differences? Uh, how how are you thinking about that opportunity?

yeah, so I'll start with just talking about the differences between the molecules does they're not published a lot about the molecule that gives us insights into

They're PK and Franco Dynamics things like that. One thing we know about the drug just in terms of the differences is just the three times a day Administration compared to twice a day, but I'll let you talk a bit about the way we're doing there specific things that we want to learn as we go through that will help inform the next stage of the study and should probably can talk about what we're hoping to learn from the phase one opponent before we move into the phase two component. So the the front portion of the safety portion, so we would be studying both a b and ends and combination and trying to understand the doors. We will also be collecting biomarkers at respectively and looking at. Marcus to understand what's the population the combination would work and once we have that understanding with preliminary efficacy and the biomarker, we would then move to the randomized portion. So that will help us guide which public want to go and have, you know have a data in the second part of the demise portion of the study.

Thank you very much.

Thank you, and we have a question from Michael with Jeffrey's your line is open.

Guys, you know your part. Yeah. Hey, I know you guys are hard at work on the launch and while that's important. Obviously it's a bit of a, you know, pre-packaged into follicular lymphoma, assuming approval in follicular and abroad label. Could you maybe talk to how the strategy involved as you are mostly targeting sort of Cancer Centers now where a lot of the patients are and then how that transitions are to what importance of transitions also to expand to community centers, perhaps where maybe there's a lot of follicular patience. So maybe just talk to the dynamic of a launching follicular and sort of how it evolved big centers versus communities and then one quick second question is just uh, I know there's a lot of different indications you guys mentioned here. Of course. The last question was about prostate cancer. Can you just describe? I guess what data if any we could get this year. Is that beige one prostate data log?

Dlbcl data may be just what data we we should pay attention to this year that we could get. Thank you.

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

this trial that they moved from one stage to the other it really high level on the strategy we're really pleased that the FDA accepted this particular film India is an snda our plan had all wage then that would be with the snda the number of the modules would be cross-referenced touch that the review for FL would be it would be a much more efficient review and we had hoped that that would help you pull the review time in and help us achieve a launch earlier and follicular lymphoma we've achieved exactly that with this now being officially named a supplemental n d a sort of the dupa dated since June so we're very pleased about that I think the other is with the launch of the S many of the the programs that we put in place to help ensure patient access the patient's first experience with the drug is a positive one those are the things we're doing right now as you know always expect with a launch you find that there are a little bit you know they're hiccups and we're having the opportunity to solve for those and make sure everything is streamlined so that by the time the FL indication is a birth

If it's approved by the FDA, all of those things are in place. It makes pay our access to so much, you know easier and quicker if we get there so that was always a part of the strategy of launching and epithelioid sarcoma first. I'll let Matt talk about how the strategy changes and then how we're evolving the commercial organization, which was built from the beginning anticipate.

Yeah, certainly Mike. So let me start at a very high level then. I'll let Matt talk about the commercial strategy and how that's going to evolve as we launch into FL and then she probably can speak to the data. This is a big year for the starting wage also have a lot of big Milestones along the way home.

Getting NFL launch, but how it now changes a bit as we prepare for the FL approval. Good morning Mike. Thanks for the question is you rightfully point out follicular lymphoma is a more of a community-based disease setting. So, uh as we've as we've talked in the past the roll around e s was to have those institutions that were responsible for managing the Epiphone coma patients the field pay structure of around nineteen people were going to ultimately be pivoting this year to get ready for the FL Market opportunity given the fact will be spending more time in the community, uh practice setting with regard to that. We've completed all of our sales force hiring. So our sales organization will be expanding we have actually completed all the hiring and we're we're I'm happy to share that we've identified forty-seven very talented individuals that will be coming on board to join our organization wage.

It'd be prepared. Well in advance of the Paducah date is Rob has referenced you know that sin.

Mid June but given the fact that we've been able to cross-reference the other modules as it relates to the es filing we want to be ready which is why we've accelerated rfl preparations. So these community-based community-based field team will now be in a position to access the high-volume clinics in the community where these patients are treated.

And like this is your father just answer your question in terms of the data. So our Focus this year is definitely to execute on these trials, especially the confirmatory trials that we have to do as well as starting other is dead in a company-sponsored trust. Most of these trials. We will have the safety portion of the study is completed including the the two E S and F L studies and the second line as well as is T's and Jose State study. So we expect to have later this year and then moving on to the expansion portion of the efficacy part of the study. We have not guided on the presentation part will be all depending on when the study's complete them will be submitted. So I think between all that might and the other, you know part of the the the out sort of wrap it up with a higher level strategic answer all of what we describe both the work to expand our commercial organization to be prepared to launch in follicular lymphoma the increase in the development activity for which we believe is very important ultimately to adding to the value of the wage.

Funny but also value to patients. All of that is now baked into the runway that we've the Apollo described which is at least into 2022. We were fortunate to be able to get close on the put option that we had with royalty Pharma just to the beginning of the year this year. And so that extends our Runway you could further and so our Runway now is at least into 2022 is

We become a commercial companies.

Thanks. I appreciate it.

Thank you and expression comes from David Leibowitz with Morgan Stanley. Your line is open. Thank you very much for taking my question piggybacking on the last question. When you look back towards a potential launch in in FL and and going into the community setting what type of trajectory should we be thinking of girls going into that population.

Well the morning, I mean, I think the first thing to think about is, of course, the high level of unmet needs is related to the patients that are living with follicular lymphoma and particularly in the relapsed and refractory said for those who have failed to Prior lines if therapy so roughly roughly speaking we can well actually we can actually say that it's a highly fragmented market place with about a third of the patients that are actually being treated with di3 kaise. The balance of the treatment opportunity is with off-label therapies recycled chemotherapies are in fact clinical trials. So when you look at a profile of tabs Barrack, we are very confident that there will be meaningful and and Rapid adoption in the later line setting again because the attributes of Physicians are seeking it are those that show that the drug is effective that the that the duration of the response It's associated with these patients is Meaningful approaching at least a year and that it's safe. So, yep.

do you think about uptake we certainly believe that will have meaningful up taking both the mutated bearing population of patients as well as the wild-type segment we would

You see that, you know right upon approval.

Thanks for taking my question.

Thank you. Just the observation that we've seen and gave it in. My opening remarks that even in the time that we've been approved epithelioid sarcoma the hotline that we have made available to patients for access the verification of benefits that we've seen coming in range is not just for epithelioid sarcoma, but we've also seen a verification of benefits for patients with follicular lymphoma as well as patients who have other eye on one negative types of tumors.

Thank you.

Thank you and have a nice question comes from Leland with Oppenheimer for line is open. Hey, good morning. Everyone. Thanks for taking my question. And I'm good to see the the progress actually wanted to ask based on just taking from the last question the use of ties in the other tumors package which lines of therapy which which combinations are we seeing? I know it's early days and the approvals only NES at this point, but just curious to know what you're seeing in terms of use patterns already in wage these you know other settings and also any reimbursement challenges that you've run into things.

Yeah, I'll start at a very high level in Matt and get into.

More specific. I think your point is probably just very early. You know, we're just a couple of weeks into the launch. I was I was interested to see that the very first verification of benefit. We got after the approval on a patient who had second line for Lincoln or lymphoma. So I think that was an indication of what adoption might look like as the drug is now commercially available, but it is early days. I'll let me speak a little bit more about what we've seen in the first few weeks. Yeah. I mean so with regard to e s we're we're really pleased as we referenced on the call from you know from the moment. The product was approved to the first prescription that came on February 1st. So our field-based team is an actively working with the es treaters and there's a lot of enthusiasm around South America and what it will be able to provide for the epithelioid sarcoma population is Rob's mentioned. There's certainly been inquiry about the role of Taz Barak in follicular lymphoma for all the undead

need reasons we've spoken about in the past and

We would anticipate that that's only going to continue as we get closer to the second approval later in the first half of this year.

We've been pleased I mean our goal was to is Matt said in his opening remarks to make sure we had drug available within ten days of the approval and within a week. We already had the first prescription where he we had talked to a patient and one of the big metrics that were following is the time from when we get the initial request time of shipment it were trying to make sure that we're averaging five days for that and just a follow-up on the on the any challenges with the payer Community. Um, we've not had a challenge with the payers. Um, we're very pleased with the performance in the speed in which they've adopted has very into their formularies, and we're just continuing to execute against the plan.

Thanks, but that's helpful. And just a quick question for shefali. This may have been asked ready. But in terms of the prostate cancer data, when might we see the first reveal from the studies in prostate things off. So in terms of the study the studies ongoing we are actually have enrolled patients. We in the safety portion of the study the safety portion of this study is planned to be completed this year and moving on to the proof of concept of randomized study. So, uh, we would hope we would expect to get the safety data. We haven't guided on the timing of the data.

Okay, great. Thanks for taking my questions.

Thank you. And as a reminder, if you would like to ask a question, press star and then the one key on your touch-tone telephone. We have a question from yarn Webber with Cowan. Your line is open Monday.

Good morning. This is Leo. I am for your own Barber congrats on the corner. And thanks for the questions. I just have two questions. First. The question is for your guidance being twenty twenty-five for the 300 or 330. Can you help us? Think about the the Opex for the following years how shall we think about the the the wage going rate for R&D and sg&a and also to a second question? Can you help us understand what you are trying to show in terms of the additional benefits by adding long has he to our square or are talking a second line or first line FL? Thank you.

It's all start by having pelo address your first question and then she can address the second. Hi. Good morning. So in terms of topics we

Just announced this morning during the call that for the this year. We are expecting a range between 230 and 255 million. We are not giving directions for following year. I think this year as we mentioned that is a quite an inflection point for sg&a because we are building up the organization of the field course to continuing the es launch and expecting the eventual FL launch and also for R&D for the confirmatory trials also the life cycle management. So for this year, we gave these directions and Thursdays. We also assume Runway with our cash position at the beginning of the at least into 2022, but we are not giving the guidance for following years.

And then following up on your question regarding the Oscar. So I think just going on in terms of defining why we are doing the study. This study was very strategically important to us. As you know, life has become the standard of care and second line plan was to actually move in earlier lines with the label expansion So the plan was to do a complimentary trial in our square and second line and that is important because you know, we really are believed in the combination based on the clinical evidence that we have and we combined with lender might it is Data with our top combination and we'll be CL that we were able to show the luminary activity. And so we are doing a very Innovative adaptive design where we have an opportunity to look at different entrance and adapt the design our our hope is to provide additive benefit to our Square in combination with our square and then compare it with our Square. We also have a maintenance portion of the study as you know that we have shown in third line and beyond that patients continue beyond progression in, Georgia.

the profession and we believe that because of the the profile that Matt and I have been talking about because of the safety profile and continue to benefit We Believe maintenance already added benefit in this study and will be important for for us in terms of following up on your second question with our job we had presented

the combination with our job in the LBC 2018 where we showed that we could combine at full dose has my side and our shop and so we are going to add an arm high-risk patient as well because as you know that our job is used in Franklin FL and so our plan is to actually provide value effort has has metastatic across all lines of FL starting with Frontline flr chop combination are square and second line and then approval and third line and Beyond

I think you've been very helpful.

Thank you, and I'm showing no further questions at this time. I'd like to turn the call back to Mister Roberts one for any closing remarks.

Okay. Well, thank you all for your questions and for joining today as you've heard. This is a incredibly exciting time representing. We're excited about how we're starting off the Year this year. We thank you for your support for the company, and we look forward to the many Milestones. They had this year. Take care everyone ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect everyone. Have a great day.

Dead dead dead dead dead.

Yep.