Q2 2020 Urogen Pharma Ltd Earnings Call
At this time, all participants on the listen only mode.
After the speaker presentation, there will be a question and answer session.
The ask a question during this session you would need to press star one on your telephone.
Please be advised that todays conference is being recorded.
If you require any footers business. Please press star zero.
I would now like to handle conference or what's your speaker today to Peter Pfreundschuh CFO. Thank you. Please go ahead.
Thank you operator, good morning, everyone and welcome to your tenant farmers second quarter 2020, <unk> financial results.
Business update conference call.
Earlier this morning, we issued a press release.
Adding an overview of our recent corporate highlights.
In financial results for the quarter ended June Thirtyth 2020.
The press release can be accessed on the investors portion the web site at investors that you're getting dot com.
Joining me on the call today or late third.
President Chief Executive Officer.
Dr. Mark Sean Burke.
Chief Medical Officer.
And Jeff.
Chief commercial officer.
Please note that we are conducting our call today from different locations. So we appreciate your patience and understanding.
Should we have any technical difficulties.
And just a minute I will turn things over to Larry's who'll provide a summary of our recent corporate development.
Mark will then share the clinical development update.
And Jeff will discuss our commercial progress made since watching gel Mito in June.
Oh yeah.
I will provide an overview of our financial highlights for the second quarter before opening up the call for questions.
As a reminder, during today's call, we will be making forward looking statements.
Various remarks, we make during this call about the company's future expectations plans and prospects.
To forward looking statements for the purpose of the safe Harbor provision.
Under the private Securities Litigation Reform Act.
It was 1995.
Actual results may differ materially from those indicated by these forward looking statements.
The result of various important factors.
Putting those discussed in the risk factor section of your hedging farmers quarterly report.
On form 10-Q filed with the S. You see this morning.
And the other filings that you're just salmon makes with the FCC from time to time.
As well as any negative effects on the urgent business.
As well is any commercialization.
Product development plans caused by work associated with Cobot 19 pandemic.
To the extent not disclosed previously.
We encourage all investors to read the company's quarterly report.
I'm form 10-Q.
And the company's other FCC filings.
These documents are available under the FCC filing section the investors page of Europeans website.
That investors start your June dot com.
In addition.
All information we provide on this conference call represent our views only as of today.
And should not be relied upon as representing our views as of any subsequent date.
Well, we may elect to update these forward looking statements at some point in the future.
We undertake no obligation to update any forward looking statements we may make on this call.
Cabot's new information.
Future events or otherwise.
I will now turn the call over to live.
Thank you Peter Good morning, everyone and thank you for joining us today I'm delighted to be speaking with you representing a company that has successfully transitioned from a clinical to commercial stage biopharmaceutical company.
Just a June one launch of job Mido for patients with low grade upper track, you'll feel cancer or low grade you to you see we had been extremely pleased with response from both physicians and patients.
We're very pleased that as of June Thirtyth 20 doses had been administered to patients and thanks to the preparedness of our team we've been able to meet every request for product and support.
Jeff will provide more details on the launch but interest has been significant and we continue to see increased demand despite the challenging environment I.
I would like to recognize and thank Jeff in the entire commercial team is they have pretty when their commitment to bringing this breakthrough therapy to patients.
Further supporting our launch efforts had been the publication of results from the pivotal phase three Olympus trial, a jump mido and the lancet oncology and in a supplement to the April 2020 issue the journal of Urology.
This data with also the focus that virtual presentation at the Twentytwenty American Urological Association annual meeting in mid May.
Additionally, Dr. Karim Cheney from U.C.L.A. highlighted the benefits of John Mito as a kidney sparing option for low grade you teach you see and review the clinical profile and safety data as part of a theater during the eight you a life meeting at the end of June.
The publication and presentation of Olympus data continue to underscore why jump might it was important to patients as the first and only approved nonsurgical chemo ablative treatment for those would this rare in difficult to treat disease.
Yeah Limpid study has now completed and we submitted an updated label to the F.D.A., including the final safety and efficacy data.
Well, there's no mandated mandated timeline for review, we believe they ft able a proven updated label and the second half Twentytwenty.
It's important to note that the final data is consistent with our previous results. So we don't anticipate significant changes to our label.
In addition to the approval and launch about first therapy, we continue to advance key initiatives designed to build a long term growth company.
This includes the presentation of updated data from the phase two optima trial of UGI and why no two at the age <unk> annual meeting in May.
No drugs are currently approved by the F.D.A. Its first line treatment for low grade intermediate risk non muscle invasive bladder cancer.
As a sizable opportunity with over 80000 addressable patients in the U.S. alone and we believe UGI and one or two has the potential to be the first F.D.A. approved therapy in this setting and an important non surgical treatment alternative for this difficult to treat patient population.
Mark we'll share our latest update to the data as of July we remain very encouraged by the positive complete response in 12 months durability data.
This data combined with the data from a left that's for low grade DTC supports the potential of UGI in one or two to have a profound impact on patients who deserve better option.
We remain on track to share the final CR and durability data from the Optima two trial by year end and we will initiate the pivotal phase three clinical study.
Mark will share the details of the trial design, including patient numbers and timing, which are in line with our previous discussions and expectations.
Additionally, our UGI had three or two program has generated a lot of excitement internally and externally. It. It has the potential to transform how high grade non muscle invasive bladder cancer is treated.
You G.N. Threeo too is a combination of UGI and to a wide our TLR seven eight agonist and Salford lung map the anti see till late for antibody we licensed from edginess.
There remains a significant unmet need in these patients. Despite recent approval at the data supporting these approvals reflects only incremental improvements and the continued need for treatment post P.C.G.
Lastly, we have a strong balance sheet and are pleased with our financial outperformance in Q2.
Peter will discuss in more detail, but our cash position allows for our current operations well into 2022, and we have no need for additional capital at this time.
We continue to search for new medicines in partnership to ensure a sustainable growth.
Early successes demonstrate the potential I brought in medicine, and strengthen our belief that we can achieve peak revenue of more than $1 billion annually from our current portfolio.
With that I'll turn the call over to Mark to discuss our recent clinical update mark.
Thank you lose we're very encouraged by the progress we've made an equally excited about what's to come I can tell you first hand that the excitement we'll watch a community about our recent advances is palpable.
As a practicing urologist I'm, particularly encouraged by the interest for my medical colleagues regarding recent launch of Joel Mito and how they can incorporate this paradigm shifting syrupy into their practices.
We had to virtual presentations.
Good.
First feature data from the Joe Mito pivotal Olympus trial in patients with mostly due to you see.
The data in the presentation also published in lancet oncology demonstrated the 59% of low grade you can see patients treated with gel Mito achieved a complete response based on interim data durability of 12 months was estimated to be 84% like Kaplan Meier analysis and median duration of response was not reach.
Overall, the most frequently reported adverse events were you were Turks analysis, urinary tract infection premature, yes, like pain and nausea.
We also shared interim data from the phase to be Optima, two trial of usually in one or two in patients with low grade intermediate risk non muscle invasive bladder cancer.
These data were also published as a supplement to the April 2020 issue of the journal and urology.
We're pleased sheer updated results as of June 19, 2020, which was consistent with our previous reports showing that 65% were 41 out of 63 patients treated with UGI on one or two which you'd be complete response three months after the start of therapy.
In the subset of patients the interim Kaplan Meier analysis shows 72.4% estimated duration of response to 12 months.
Also this includes only patients were present revaluation and each time.
Follow up of these patients will continue into all patients have reached the 12 month going forward.
The most common adverse events greater than 10%.
Reported as mild to moderate and includes urea mature area urinary frequency to key urgency and urinary tract infection.
These data continue to validate our hypothesis that increased well find significantly improves the effectiveness of intravesical therapy.
Got you do you see a non muscle invasive bladder cancer are treated by repetitive surgical intervention, which carries associated risks and an elderly population.
Sure Joe Mito UGI in one or two may have the potential to fundamentally change the way Mowbray intermediate risk non muscle invasive bladder cancer is treated and help patients avoid recurrence of their cancer and repetitive surgeries. This time in a much larger patient population.
We have agreed to the design elements of our phase three study.
And are finalizing the protocol study will be a randomized controlled trial and approximately 600 patients of UGI on one or two with or without to you RBC versus you RBC alone in patients with low grade non muscle invasive bladder cancer intermediate risk of recurrence patients will be randomized.
Either UGI in one or two plus or minus few RBC were to you RBC alone.
That's a three month Tri Pointe patients will be as faster response.
Patients who have demonstrated a complete response eager UGI on one or two or keyword BT will continue for long term for patients who demonstrated recurrency either arm will undergo a t. RBC.
Based on previous phase two data generated in this population we believe the majority of patients treated with UGI on one or two will not require a few RB tier three months.
The primary endpoint of this study is disease free survival. In this study is designed to conclude superiority and door non inferiority.
We expect completion of the study when an approximately three years with the potential to stop early at pre specified interim analyses.
We are excited by the robustness of the study design, which is important and given the potential UGI on one or two has significantly disrupt current treatment paradigm.
We want to ensure patients have access as soon as possible and the head to head comparison is expected to generate data demonstrating the value of treating patients with UGI and one or two versus repetitive surgical intervention.
Before I turn things over to Jeff I want to provide a little more detail on UGI I'm thrilled to.
A combination or UGI and to a one which is our TLR seven agonist as a monotherapy and sell a fill a man and the answer you see Chile for antibody, which we are developing high grade non muscle invasive bladder cancer.
Patients with this disease or at higher risk rapid progression within increased risk developing a life threatening illness.
The disease, primarily impacts people in their sixtys and seventies, often with other co morbidities non surgical treatment options are vital importance.
The current standard of care for high grade non muscle invasive bladder cancer is transferred to resection of letter tumor or few RBC. In addition to DCG.
Those who do not respond to BCG didn't receive alternative intra vessel therapies enroll clinical trial or undergo radical suspecting which is a complex surgery involving plateau removal and urinary tract reconstruction using a segment of the intestinal tract.
This operation is associated with all of the typical risks of a major surgery and specific risks such as dehydration electrolyte abnormalities urinary tract infection Bell obstruction and your her blockage.
I suspect to me is associated with high rates of complication.
Including gastrointestinal dysfunction.
His heart attacks and Doug.
The hypothesis that the preclinical team has been working on is the carbon interoil immunotherapy is feasible and meaningful when applying locally which is a very novel idea delivering the combination intra desecrate me sidestep systemic side effects and adverse events associated with systemic immune out there.
Yeah.
What we found is that a combination of new GM tumor one with him and he see feeling for antibody, resulting smaller tumors and better survival mice and some changes in immunological markers such as decreased T regulatory cells and increased CDH T. Reg.
Ratios are murine model.
We think these data support dancing this program into human trials as this may represent a novel approach to managing high grade disease that as otherwise sale therapy with contemporary standards of care.
It was mentioned this program has generated considerable interest based on its potential dramatically change how we treat this disease.
I'd like to now turn the call over to Jeff.
Thank you Mark I'm excited to speak with you today on the heels of larger of June 1st still Mito launch, which is executed ahead of our timing and guide the street as list shared interests and Joe Mito has been significant demand continued to increase despite challenging environment.
Thanks to the efforts of our entire team we booked almost $400000 in net sales as of June Thirtyth.
We are definitely off to a solid start and I remain optimistic that we can sustain our early momentum moving forward.
Well patient access is challenging in today's environment due to covert 19, we are seeing patients able to be treated.
Our field personnel have been limited and they live interactions with physicians, especially in areas of the country, where infection rates are on the right, but we have increased our investment in digital tools and are finding HCP open to engaging with us virtually.
Importantly, while some states are not allowing certain surgical procedures, including our news Joe Mito can be instilled in a clinic and when patients are treated in a hospital setting it's an outpatient procedure typically under local in seed.
That most installations to date have been under local anesthesia.
I think that its flexibility, we haven't heard about procedures being canceled or delayed due to cobot 19, and we've been able to treat patients in state fit disproportionately hard by the virus include California, and New Jersey, which is where our first patient was treated in June.
While we are obviously early in our launch we see many positive indicators to date, we've activated roughly 100 site, which means they have completed their internal processes and have already to treat patients.
It includes sites, who participated in the phase three Olympus trial.
We've also had two accounts treat more than one patient. This is an important metric to show that the process. We have put in place has been smooth and the account is identifying other patients who could benefit from the treatment with till Mito.
To date, roughly 75% of treating physicians will not part of our phase three trial. This isn't surprising giving you do you see the disease predominantly diagnosed in the community, but it underscores the fact that we've been focused on the right targets and were able to generate broad awareness of Joe Mito amongst community urologist it.
Also validates our mixing strategy and the utility of the partnership we established with options here.
From a coating and reimbursement perspective, we have committed significant resources to working with our top blood counts and institutional accounts as a result multiple treatments have already been successfully reimbursed.
Additionally, thanks to our market access seen we were able to complete both RC and J code applications. We're on track to receive our C code in September which means it will go into effect in October and R. J code in January of next year.
So again, we're definitely off to a solid start if you feel we are well positioned to build on the momentum we generated since our June 1st launch.
Before I turn things over to Peter I want to recognize an a plus the efforts of health care providers and staff, who have worked collaboratively with us to bring gel mido to patients. It's certainly been a challenging couple of months, but our team has overcome every optical and remain committed to do so whatever is necessary to address the unmet need in the euro.
The community with this novel and effective kidney bearing treatment option.
The work, we're doing now well not only help us to achieve our short term goals, but we'll build a foundation for future success with UGI in one or two and the other opportunities in our pipeline.
And with that I'd like to turn it over the call over to Peter will discuss financials.
Thank you.
Good morning, everyone on today's call.
Virgin recorded net product sales of Joe Mito, the second quarter of 2020.
Approximately 371.5 thousand.
Reflecting sales only during the month of June 2020.
Associated cost <unk> revenues were approximately 48.2 thousand.
Including certain one time initial costs.
In periods prior to receiving FDA approval, we're Joe Mito.
A company recognized inventory and related costs associated with manufactured and Joe Mido.
As research and development expenses.
We expect this continued to impact our cost of revenues.
During the fourth quarter of 2021.
As we produce Joe Mido Cox, reflecting the full cost manufacturing.
And as we the Threeq piece inventories.
We had expense prior to receiving FDA approval.
For the second quarter ended June Thirtyth 2020, we recorded a net loss.
31.3 million or $1.44 cents per share.
This compares to in that was approximately 22.5 million.
$1.80 cents per share so the same period 29 king.
The net loss for the second quarter ended June Thirtyth 2020.
Includes 7.1 million in noncash share based compensation expense.
As compared to 7.2 million to the same period in 2019.
For the six months ended June Thirtyth 2020.
We recorded and that walks of 69.1 million.
We're $3.22 per share.
This compares to a net loss of approximately.
43.9 billion or $2.19 per share the same period in 2019.
And that walks through the six months ended June Thirtyth 2020.
Includes 14 point, Sevenmillion and noncash share based compensation expense.
As compared to 14.79 for the same period in 2019.
Research and development expenses for the second quarter ended June Thirtyth 2024 8.1 million.
As compared to $10 million to the same period in 2019.
Research and development expenses also include 1.6 million noncash share based compensation expense, where the second quarter ended June 30 2020.
As compared to 2 million into the same period in 2019.
The decrease in research and development expenses from 29 2020.
It was mainly attributable to the completion of the phase three clinical trials.
And regulatory activity for you, Jim one or one.
And decreased activity related to you Gen one or two.
Phase two clinical trials.
Partially offset by an increase of healthcare related costs.
Anticipation that you can one or two phase three clinical trials.
Research and development expenses for the six months ended June Thirtyth, 2020, or 24.7 billion.
As compared to 19.7 million to the same period in 29 King.
Research and development expenses also included 3.5 million noncash share based compensation expense for the six months ended June Thirtyth 2020.
As compared to 4.39 for the same period in 2019.
In addition to the above.
Krishna research and development expenses for the six months ended June Thirtyth.
2019 to 2020.
It was mainly attributable to a onetime payment of 6.6 million.
To unwind the company's obligation.
To the Israeli innovation authority during the first quarter of 2020.
Selling and marketing expenses for the second quarter ended June Thirtyth 2020 work.
I'll 0.8, compared to 3.2 million for the same period and 29 King.
Selling and marketing expenses include.
1.2 million dollar share based compensation expense the second quarter ended June 30 2020.
As compared to 2.5 million to the same period and 29 King.
The increase in selling and marketing expenses resulted from increased cost of activities related to the launch of gel mito, including headcount related costs associated with our sales force.
Selling and marketing expenses for the six months ended June 30, 2020 were 23.4 million.
Compared to 5.8 million for the same period in 29 team.
Selling and marketing expenses include 2.3 million.
Noncash share based compensation expense for the six months ended June Thirtyth right 20.
As compared to point 9 million for the same period between 19.
The increase in selling and marketing expenses.
Resulted from increased costs and activities related to the launch of gel Mito.
Including headcount related cost associated with our sales force.
General and administrative expenses for the second quarter ended June Thirtyth 2020 were 11.3 million.
As compared to 10.6 million.
The same period and 29 team.
General administrative expenses include four point Threemillion noncash share based compensation expense.
The second quarter ended June Thirtyth 2020.
That's compared to 4.7 billion.
Same period in 2019.
The increase in general administrative expenses from 29 to 2020 resulted primarily from an increase in costs supported the buildout of our company.
Commercialization of our first products.
And consulting and other outside seed.
General and administrative expenses for the six months ended June Thirtyth twice, Tony were 22 point Sixmillion.
As compared to 20.7 million for the same period and 29 team.
General and administrative expenses include 8.9 million.
Noncash share based compensation expense for the six months ended June 30 2020.
As compared to 9.4 billion for the same period in 2019.
The increase in general and administrative expenses from 2019 to 2020.
Resulted primarily from an increase in cost as part of the Bill does the company.
For the commercialization of our first product.
And.
Consulting and other outside fees.
We closed the second quarter 2020, with 151.6 million in cash cash equivalents in marketable securities.
This excludes restricted cash.
Current balance sheet supports the company well into 2022.
As we ramp the commercialization of Joe Mito.
And start to see offsetting operating margin.
Cash inflows from commercial sales.
This will allow us to vigorously advanced clinical development of you'd you had one or two.
As well as other clinical programs already in the pipeline.
With that operator.
I would like to turn the call over for questions.
Thank you Sir.
As a reminder to ask a question you would need to press star one on your telephone.
Which are your question. Please press the pound key.
Please standby, while we compiled acuity roster.
I sure first question comes from the line of Ram Selvaraju from H.C. Wainwright. Please go ahead.
Hi, This is Blake around for couple of questions for me first can you talk little bit more about how cobot that affected the launch of gel mitel and what kind of strategies are you implying to mitigate impact.
Do you anticipate any more normalized commercial environment to materialize later on and how is your virtual platform been function, thus far and wide the tenants that Mike.
Hi, Blair players. Thanks for joining I would just make a couple of comments I'm a turn it over to Jeff to that can give you more specifics around it I think as Jeff mentioned earlier, we have not seen an issue and patients actually get scheduled with them coming in.
I have their medicine, and Jeff also mentioned that in some state yeah, they're not really allowing face to face interaction with the representative been so that's why a lot of what we're doing as a virtual but but I do want to comment that we also have as as we've talked about before nurse educators and medical science liaison.
And they are able to go in and educate Dr is going to answer any questions that they have.
My personal opinion, and we have no data that sort of a shows this.
But if you can look at Reed overall, you are seeing sort of Oh, I would say a reduced patient engagement with position to overall not just for us but for everyone.
I will tell you that despite.
Any of that we are well ahead of where we expected to be right. Now so we don't really see it impacting us.
Specifically right now I think the impact of cold weather will be yet to be determined and what I mean by that is it depends on what happens over the next few months.
Because like I said to you can read everywhere that they'll show that cancer diagnosis and treatment as down over 40%, but.
But to Jeff's point, we haven't seen that specifically, but we are seeing some of the limited engagement because of that so I think a and Jeff can talk more about the strategies to impact I think we just got have it's a fluid situation, but despite all of that I think it's really important feed and noted that the number of patients we have in the pipeline.
And the number of patients that we treated so far is well above what we expected to be right. Now. So I think it's still something we need to be very cognizant of and and I'll turn it over to Jeff to talk more about our strategy. So Jeff.
Sure. Thanks, Louis So we've done as we've increased our resources in investment in our digital platform as well as our non personal promotion, so I think everyone.
The CD virtual AG way that was successfully rolled out.
Continues to get.
What we can measure click throughs, how long folks stay on the site continues to be well above industry average.
And as we've said I mean the.
It is a fluid situation actually hospitals, but a lot of hospitals can't perform an Orion you. Its an overnight surgery I talked to a couple of physicians were well that's a surgery that they can outperform right now.
Until gel Mito becomes another option because as we said it can be given in an outpatient setting under under a local.
But those are some of the certainly to increase just to keep the awareness high.
In major periodic periodicals that urologist.
Read we're increasing our investment there.
And really anything that holding a younger things that are we're working through our typically the.
Internal prophecies of our customers or whether that's a in form of formulary review.
Or whether that's just making sure we sit down and meet with billing and coding.
We haven't had delays due to cope with 19.
Okay, Great and could you talk a little bit about the impact to the inclusion of the NCCN clinical practice guidelines for Jim Ita.
Sure first of all is a record inclusion I think NCCN also recognizes our unmet need in this area.
And so they are included it quickly in their guidelines, we have a will work with NCCN to communicate that that'll be a piece. We can promote that the inclusion of the guidelines any any sort of inclusion like that.
Certainly something that will help a brand that will help our promotional team go out with and so its than it's been a positive and even more so that it came very very soon after launch.
I think the other only comment about the NCCN guidelines, you know a lot of payers follow NCCN guidelines and yeah. The and so that also helps that certainly we think about any reimbursement as we go forward.
Player.
Okay, Great and then if I could just squeeze in one more real quick.
Do you anticipate any impediments to enrollment with one or two that pivotal study.
Tim Cope Nike.
We actually do not at this point and mainly because a we have increased our number of site.
Outside of the U.S. and some of the eastern European markets, where we don't see where they're not seeing the co bid or the delays because of that so we expect that it may have some delay in the U.S., but we've all the already plan for that and and don't expect it to impact our moment at all.
Okay, great. Thank you.
Thank you I'm next question comes from Derrick our children from Stifel. Please go ahead.
Hey, Thanks, guys. This is Ben Hartford, Derek Thanks for taking my call.
I'm just wondering if you guys to comment on the number of patients who are actually using.
Yeah, John right now.
And then how many docs are actually doing it too and then does vary by yes.
Vary by parts of the country.
And that's it for us thanks.
Yeah, its sleds and I've had the number we had talked about the 20 doses I will share with you that that that was eight patients and in June we probably going forward, we're not going to every month. Our every quarter give all of that patient numbers as we start to get you know get into their our revenue generation.
But I think it's important for you to know that that in the reason I shared that is because it shows that we've gotten both new patients as well as repeat patients. So so as you know you know as we go into the Montana weeks. These patients are getting sticks weekly doses. So it's important that they continued to get that all six.
So we do have patients in that GE them timeframe that got one we've got patient said you know got multiple multiple doses.
I'll, let Jeff talk about the physician that are engaged so just plays and like I said, we're not we can't share numbers. After Q2, but I'll just remark that we're continuing to see progress and happy with our progress has to go into like Q3. So Jeff do you just want to comment about adopted.
Vision, yeah, without giving too much specific information, but that's in this early stage.
Yeah, no. The we've had a a growing number of interest in physician enforcement really and and academic setting into your question around do we have sort of pockets, we don't I'm not saying that I can say you know we've got patience.
Well in California are first patient was in new Jersey, or we just recently adaptation.
In long island, which as you know, it's a hard hit area or we also had patients in Missouri, and so we're not seeing sort of a geographical.
Impact with regard to a patient access.
So hopefully that helps.
Yeah, Okay. Thanks, guys.
Thank you.
Our next question comes from the line of Boris Peaker from Cowen. Please go ahead.
Hi, good morning off for Jamire I'm, just curious do you anticipate a stronger uptake in the academic or commute any community settings, and if you can also expand on what are some of the economic implications for using the drug.
Both of these settings.
Yeah, Jeff why don't you answer that.
Sure. So we believe that most of the a and it's proven to be true and then in the patients that we've got today most of the diagnosis occurs in the community. We think that that will be probably 75% a patients having said that some of the patients that we've received or.
We're part of our went to our phase three positions that were part of Olympus. So those are as you know big referral centers will continue to be that Ah. So there'll be very important for gel mito as well, but as we see see that the majority.
A patients are diagnosed in the community and depending on.
Where are the urologist does his or her surgery that will be dependent on where they go to to actually administer the question.
And with regards to.
From a financial standpoint. This is a fine built drug so part B isn't boy.
So positions now or are lining up you know their claim submission or they will fill out the appropriate forms to be reimbursed.
At buy and Bill a reimbursement will will you know it'll be consistent until till we get an established asap.
And depending on the Mac carrier on their nine to 10, Max that cut that cover Medicare throughout the nation.
Will reimburse either a 95% of eight WPP or walk plus model until we establish an A.S.P., which we expect the ASP to be in January but yet they they certainly they understand buying bill from drugs like programs and so you go. So this is not.
The new to them, which which we're fortunate that we don't have to kind of a safe that hurdle there are very familiar with the buy and bill landscape.
Gotcha.
And my last question or what's the status of the European update.
When should we be hearing from there.
Yeah, we we just recently engaged a small from there that have to principles that actually were part of the in May and we're working through that as we've said before so we expect to have a plan and the next couple of months.
As we've stated before the issue isn't so much getting an approval on its really getting reimbursement. So we've got to work through countries like Germany and France.
And we've got a upcoming meetings around what would it actually take to get good reimbursement there because they use the compared a model that a challenging situation par for one on one with the head to head in one of two we won't have that issue, but we do want to make sure that we have an available. We also have engaged.
In Japan.
The regulatory authorities and so we're working through those and I think we'll see something in the next three four months what habits more clear plan.
We need to do another study or what exactly we would need to watch commercialized in those geography.
Great. Thank you very much for taking my questions.
Thank you thanks Derek.
Thank you I'm next question comes from the line of Leland Gershell from Oppenheimer. Please go ahead.
Hi, good morning, Thanks for taking my questions.
First a question on on commercial or I guess for Jeff, but also maybe for Mark as well you know we've had some recent publications in the garlic literature that reviewed the.
Data from past studies in different tumors with regard to you know how long patients can go without treatments and what the outcomes would be whereas when nikobar 19 environment as urologist sort of Treehouse you know those patients who are more important to see first versus later in terms of intervention want to ask about you know with.
Oh, Great you to you see what extent do you think that urologist will do for therapy, even though you haven't seen evidence perhaps of that.
Good to prioritize treatment for patients who have more aggressive really good stewards disease.
Same time with hospitals, not perhaps some hospitals not doing or a news urologist may have more more off this time to to do those types of being off as procedures for earlier stage cancer. It's how should we think about kind of those two per school for factors as we go through the kind on a then it got a couple of R&D questions like.
Yeah, So Jeff once you start parcel non mark.
Okay perspective from a position standpoint, and then answer your R&D question.
Yes sure. So what we've heard is just like everyone is trying to fine.
Solutions and to the Cobot 19, our physicians are doing that as well and so yeah. We I'll give you. An example, where a patient didn't want to go to the hospital and physician or actually sought out awesome surgery centers to where the pace it would feel more comfortable peak.
As the Sunedison said to me and I'll, let mark alluded to.
How long patients would wait but the you know.
Patient for minded.
Perhaps every day that their cancer is back there's significant there can be significant amount of blood and urine.
And further anxiety levels as you can American go up.
As a as there has the time before any sort of treatment occurs. So we're finding a physicians are working with.
There are patients they're working to make their patients feel comfortable in areas, where either hospital access is not there right now other prioritizing other patients.
Or just the younger patients as I alluded to the patients in this case is uncomfortable going through a hospital Mark you want to come up.
Yeah Leland, it's a great question I think as you might well anticipate everyone is struggling were all struggling with huge backlogs in patients who were delayed because of the limitations on the availability of elective surgery time.
For for patients just like this so we're doing all the things that you have to us.
Described.
But I do think actually the circumstances provide an opportunity for physicians within creatively about how to treat patients with liver disease. So in theory.
Paradoxical way.
But has provided an interesting opportunity for physicians to releasing through.
Alternative if you're a piece for patients with liver disease, obviously, Joel miner is such an alternative so.
Paradoxical actually push physicians and patients to consider this therapy.
More readily than they might otherwise.
Alright. Thank you and then on the R&D side one question on until my though I believe you had to study.
There was little them, but certainly do capacity, where you were looking at.
John later in the maintenance setting for longer term use and or patients coming back onto on my though after initial users that have recurrence want to ask about where the status of goes data or and also with regard to they're putting bladder trial.
Mark you mentioned, a couple of interim opportunities may be too earlier.
Kind of moving advancement into into a filing onetimes could you give any more color around what what the bars would be covered some interims thing.
Sure. Thanks, So with respect to maintenance I think the Lansing article actually because of very good description of what we do you don't know about maintenance and what we do know is that most patients in the trial received a dose at least of maintenance there.
But the application maintenance across the trial.
So individualized.
As to making your difficult for us to drawing conclusions about the value of maintenance in this context. So that's really the use of maintenance is really left to physician discretion.
The context of institutional might own treatment of our Patrick.
Disease.
With respect to Retreatment Oh, we are consequently, we treatment program, because obviously that would be very valuable to patients who had a good response and.
And then relapse, so we would want to.
Certainly the.
The utility of Retreatment and turn it to do that we had we had a retreatment trial.
Open but unfortunately.
We didn't have any patients treated so we're going to re initiate that program as we continue to phone patients in the journal might have group because we can continue to fall this patients for three years for additional information.
[music].
And then finally.
With respect to the bladder program.
In the bladder Freestor is three we haven't really disclose what the with the bars would be for really.
Earlier closure revaluation of the data but.
Obviously part of the design and as we initiate the trial and stork accumulate information if they are exciting updates I'm sure I'm sure we'll be sharing with you, but we had specific we talked about that yet.
Great. Thanks for taking my question.
Thank you next question comes from Paul Choice from Goldman Sachs. Please go ahead.
Hi, Thank you and good morning, everyone. Congrats on all the progress.
Two pipeline questions for me, if I could first on one or two and the planned phase three that's going to start later this year can you maybe just clarify for US just in terms of potential patient stratification. How your if any are going to include with regard to risk factors and door prior target.
Experience or or only naive patients and then I had a follow up question with that.
Mark you want to go ahead and answer that yeah sure Paul Thank you.
So great question. This is in our phase two study as you know the study, including both patients with.
New disease patients, who had not previously treated as wells patients who have occurred and in fact, we know the majority patients in the phase two trial for patients with the prior history of tumor which is very characteristic as I'm sure. You know of the group we are focusing on which is the intermediate risk luxury population.
And just to remind everyone intermediate risk is disease that is low grade for the most part.
And University will be low grade multi focal larger tumors and very importantly history prior.
Treatment for relapsing disease, So we will be focusing on exactly the same.
I feel issue, we looked at in the phase two trial and would expect that.
Do might well be a greater number of patients with recurrent disease because that is the nature of the population there will likely also be patients.
With de Novo disease as well.
Okay. Thanks for that clarification, Mark and then my second pipeline question is on three or two and specifically with regard to sort of next steps and potential data updates either for out for two or one or for that zeller fretful about CTO before either when you would might potentially provide either monotherapy lower.
Updates thank you very much.
Paul Thanks.
So we are on we are working even just internally.
As we have.
Previously our plan is to.
You mean shooting human trial.
As part of this comprises program.
This year.
And I've got to store attention, but we haven't disclosed any additional details about that and some of this is as I think you can well imagine a series of.
The complex interactions on completing the clinical trial with various preclinical.
Activities as well to including some aspects of formulation, but our plan is to go ahead with with clinical experience.
Looking into this year and we'll see.
As we have more specifics to ship.
Thank you very much.
Thank you.
I last question comes from the line of Matt Kaplan from Ladenburg Thalmann. Please go ahead.
Hey, guys. Good morning. Thanks next question just wanted to follow up a little bit more on.
The one on two phase three clinical trial design and and timeline Mark maybe perhaps you can give us one.
Our lives some additional detail in terms of what what you expect the primary endpoint to be and the potential timeline for that.
None of that.
Yeah, I think my Oh, Hi, Matt Thanks for joining Mark gave most of the data.
During his comments section, but it's it's around 600 patients and we expect enrollment to be completed within a year as I mentioned juranek earlier, Q and a large portion of the patients will be outside of the you asked to ensure that our enrollment has not slowed down at all by by the pants and make them are very confident.
And and what we've been doing the work that the development team has been doing under Mark and specifically around getting some accelerated.
We are always in place them. So we are we are well underway.
To start that study and so we feel really good about it and done as Mike mentioned, we have we have a couple of pre specified interim analysis.
To ensure that at point in quite look it's an event driven trial. So we can't tell you exactly what the timing will be but our port tend to very conservative projection.
Say that it would be complete within three years and that that's assuming it goes all the way through I mean, it had both noninferiority on superiority and so that's sort of the data.
Guidelines that will be following again, it's an EBIT event driven study there'll be a day data monitoring committee, which he will be taking a look at the data.
Hello.
Okay fine that to us and so I think I just want to give you all of the information we have at this point I'm not sure market. If I missed anything that's something you want odd.
No listening so that I think that's what we can share right well I'm sorry, yes about they tend to fly.
Yeah, I'm, sorry, Mark he asked about the and talk about so right. So.
Yes so.
Obviously in this game with this disease the issue is managing recurrence show.
No.
Typical sending we'd be talking them recurrence free.
Survival for this talking when she said I hope that helps with that particular request.
Right now thanks, Thanks was thanks, Mark and congrats on on progress.
Thank you.
Thank you. This concludes our county session at this time I like to turn the call over to lose Barrett for closing comments. Please go ahead.
Great. Thank you. Thank you operator.
We've made significant progress and 2020, we look forward to continue the momentum as it has been as I've mentioned, a couple of times on the call a better than we expected even including in the pandemic that.
Hit the ground running from a commercial standpoint, we've hit every milestone with a positive outcome that youve heard Peter talk about our financial financial situation. You know the team is really Sean creativity and resilient launching our first product as we navigate through cobot night team and I'm really confident our ability to continue to.
Advance the mission to pioneer new treatments for to improve patient care, especially cancers and neurologic diseases no. Our overall fundamentals that long term prospects remain strong our team continues to work around the clock to make sure that we provide jump mido to patients and you know who have been waiting for better options and some as we make price.
Breadth with our commercial launch we advance our pipeline of innovative medicines and we look forward to providing you with further updates. So we really appreciate your time and interest in our company and for your continued support. So operator you may disconnect at this time. Thank you.
Thank you ladies and gentlemen, this concludes todays conference call. Thank you for participating you may now disconnect good day.
[music].