Q1 2020 Earnings Call

It's per standing by to walk into the clothes from called G. first quarter 2020 financial results Conference call. This.

This tumble participant ornaments only mode actually the speakers presentations it'd be a question to answer session ask the question your associated press Star one on your telephone.

Watches based company has been recorded if you're quite a further assistance. Please press start here and I like to convert over two speakers day and it's something please press it up and that's relations. Thank you. Please go ahead.

Okay. Good afternoon, everyone welcome to the clever psychology first quarter 2020 conference call. Thank you for joining us.

He's likely seen this afternoon's news release, it's not available on her website.

Reminders comes calling theme of course, it recorders in one cat.

Remoxy access might on her website during the call and will be available in our cost of the next several weeks.

Today's agenda includes the following haven't happy or President <unk>, we'll discuss to keep them find some highlights subsidies corporate update.

I didn't commentary about any potential impacts related.

19.

And then you all closest chief natural several covered quarters financial results in greater detail.

It would make a few closing remarks and no <unk> during which time Lindsay Robert Chief Medical care will also be available to answer questions.

Before we begin please note the during today's conference call. We may make forward looking statements are going to need to have the federal security sauce.

Savings inserting ER mental outlook I expected business plans.

All these statements are subject risks and uncertainties because actually result, it different materially from those described in the far that can statements are actual results could different materially do a number of factors, including next continuation of the effects of coding 19 pandemic.

I prefer to our recent falling to the S.P.C. for overview of the risks uncertainties associated with our business.

Or the keys Damon speak only as as the date and I wish there may even causes under case no obligation to update or provide any forward looking statements now trying to call over to patent happy.

Yeah, well come everybody Christian you've taken the time today.

As we all know the world has changed so much since or less fully updated in late February so complicated time for all of you I know.

Don't care professionals have been and remain on the front lines at the oval pandemic.

I'd like to acknowledge the contributions of health care workers around the room, putting the lines on the line to care for those affected by cope with 19.

Closer to home, we'd also like to recognize the tremendous effort being me by investigators and prescribers to maintain enrollment and safely manage ongoing patients are clinical trials and for continuing to prescribe to manage Rebecca commercial patient.

During this period of significant upheaval to their clinics and practices.

Well you start times eight to discuss the highlights of the topics you've come to expect on record recalls and focus on providing additional color and how we are navigating the corporate 19 world your oldest.

In our view October 19 may affect ontology treatment going forward and then we'll open open it up for today with Dan.

Lindsay myself.

Let's begin with the commercial update fruit Braca I'm pleased to report that we had a very encouraging first quarter or global net revenue was 42.6 million.

Presents an eight per cent sequence will increase from Q. for 2019, and 29% increase over Q1 20 Nike.

This was our best quarter of sales today. Despite the fact, the bread tend to begin stay home beginning in mid March in the United States.

No longer colon health care providers in person for the last few weeks recorder.

Also our European launches in Italy, Spain, and trains are all occurring in that environment, which are feel based personnel have not been allowed to visit hospitals were clinics beginning in late February.

They're also working from home.

Given the circumstances, we're very pleased with our sales growth in the first quarter.

And now all sure why we believe that were bracket as well positioned as I'm allergy treatment option in the current acute cope with 19 era.

And in the chronic covert environment that a shortfall.

This is period has been very disruptive for hospitals clinics and patience as healthcare professionals are redirected.

Broadly described elective procedures or delayed and healthcare facilities are converted to support covert 19 treatment efforts.

We do believe that ontology will be among the first healthcare specialty to return to some normalcy well that likely means adapting to a new normal in a chronicled the <unk>.

One in which there is a focus on minimizing clinical digits to avoid risk to patients.

Especially cancer patients and other patients, but no go more than.

It is also clear that cancer patients will need to be diagnosed and treated.

Given the evident Reds and not actively managing their disease.

We believe in Nebraska convenient for therapy has significant advantages as a maintenance maintenance option and recurrent ovarian cancer setting.

In an environment in as I described positions are trying to reduce patient visits to their products.

Unlike of as soon as a maintenance option that requires frequent infusions and we'd be monitoring for hypertension, no respect for for coping 19 <unk>.

<unk> it was taken at home and only requires monthly routine monitor.

Unlike observation, which on average leads to disease progression and requires a returns that minister oppressive chemotherapy for.

For approximately five month.

Nebraska has been shown to extend progression pre survival and therefore subsequent chemotherapy on average nearly 14 months by independent assessment, nearly three times longer than placebo.

In fact observation is an invitation to an infusion.

And unlike Cinderella, which requires weekly blood monitoring for the first month, which obviously requires weekly visits to the clinical or laboratory for Bracker requires only monthly routine monitor.

You can see Rebecca offers numerous potential advantages in a chronic called the 19 were and we have already introduced a variety of new digital materials for our our now hold them based field personnel to use to engage with hospitals clinics doctors and pharmacies.

Well, we may see some near term impact on revenues dispositions adaptor practices to cope with 19.

We believe these advantages will remain over the course of this year in future years since as we all know covert 19 is not likely going away in the near term.

In addition to seeking to establish <unk>, because the maintenance treatment option of choice and recurrent ovarian cancer.

Also look forward to the potential launch in the United States <unk> prostate cancer.

And that brings us to our most near term development and regulatory program in this setting.

November 2019, we submitted our plan supplemental new drug application was indeed.

<unk> as a monotherapies treatment of adult patients with Franco one or two <unk> recurrent better static C.R.P.C.

You have the filing was based on data from the training to clinical program in advanced prostate cancer.

In the U.S. by the way approximately 12% have been better static C.R.P.C.

Mutation, Nebraska, one or two in their timber.

In January 2020, we announced at the at the gay accepted R.S.N.D. for Rebecca and granted priority review status to the application with the do for date of me 15 2020.

Based on our interactions with the F.D.A., we have no reason to expect any delay tore me 15 to do for a day.

We think that Rebecca represents an important <unk> chemotherapy free option commend the better static C.R.P.C. in Nebraska, one two mutation.

Recall that we've previously reported as mould. It last fall I confirmed objective responded trade of 44% by investigator and it confirmed P.S.A. response of 52%.

Safety data for amendments T.R.P.C., you were consistent with prior seek to reports for patients with ovarian cancer and other solid tumors.

We've been engaged <unk> encouraged by our interactions with both the middle income medical oncology and neurology communities about the potential for Rebecca to address the unmet medical need in recurrent met a static C.R.P.C.

We are actively engaged and lunch preparations, including sales force training that was completed in early March and we will be ready to launch upon approval.

Obviously this will be among the first group of ontology launches, but will incur entirely almost entirely virtually.

And we have taken considerable effort to prepare for this virtual lunch.

Outfield sales team is prepared to initiate zoom based sales calls with prescribers and we'll leverage learnings accumulated through their virtual selling effort to the ovarian cancer of setting since bit marks.

Oh loans collateral for the sales team has been digitized to ensure they have the ability to utilize resources in virtual interactions.

Promotional national broadcast has been fully converted to a virtual steaming program, enabling U.C.P. used to watch from any computer or I pad or any device in their office for.

Additional broadcasts times I've been added doing for flexibility across Oh, U.S. time zones.

Program registration will be added to target it online advertising will commence the date of approval.

Media advertising efforts have been waited for digital programming <unk> right now.

Maximize impact and effectiveness of resources can best.

So to be clear, we will be ready to launch in prostate even in this new environment.

Let me turn out to the clinical pipeline through bracket and was sitting in as well as our ongoing plans for S.A.P. 22 86.

To begin we are adhering to the regulatory guidance that F.T.A. and other agencies have provided regarding clinical trial conduct during cold in 19 or clinical teams are working closely with investigators to ensure the safety of trial participants and investigators or maintaining complains with good clinical practice and minimizing risk to the integrity.

Well, we did not see any material disruption poor clinical trials as a result to cope with 19 during the first quarter.

It is possible that near term effects may begin to emerge across different aspects of our clinical trial programs.

For example, do patient recruitment in certain clinical studies may be affected them. The conduct of clinical trials may vary by geography as some regions are more adversely affected.

I will know that we continue to anticipate competing enrollment in our largest <unk>.

Theano frontline maintenance study before the end of this corner.

Load sort of study or fees to Penn tumor study to evaluate Rebecca in homologous for accommodation repaired beans across tumor type continues to an old patients.

The study will evaluate Rebecca in patients with for current solid tumors associated with the deleterious symbolic is for combination repair or H.R.R.G. mutation.

Based on her interactions with F.T.A. This study maybe registration enabling for a targeted Jean in tumor agnostic label.

If a woman continues as planes, we could potentially file for approval and 2021.

[noise] next I'd like to briefly highlight or combinations studies with B.M.S. for both were Braca endless fitness and then discuss our newest <unk> 22 86.

The remaining through the stick it better ongoing clinical collaboration with somebody was quit.

Take a moment to review certain of our combinations studies for both <unk> <unk>.

Oh begin with Rebecca combinations.

Fraction D.C. is a B.M.S. sponsored maltais arm things to study evaluating the combinations of each of poor people and your boy with Rebecca as well as well <unk> Your voice and Rebecca in combination for the treatment of advanced gastric cancer.

This was the first sponsored study to explore this triplets combination and that is currently enrolling patients into the safety of beating portion of the study.

Well the sponsored feet three a senior trial and first line maintenance for advanced ovarian cancer continues to enroll well despite the coping 19 environment and as I noted we continue to anticipate competing enrollment in this 1000 patients study in the second quarter of 2020.

With a female we believe we are uniquely positioned to evaluate were bracket in terms of two outcomes as motto therapy versus placebo in the first line maintenance setting in the H.R.D. population.

Inclusive up rack and then the all comers or intend to treat population as well as any potential advantage of the combination of a bracket it'll diebel in the same patient populations.

A peanut is the first frontline switched maintenance study designed to show called <unk> Monotherapies <unk> combination therapy, and one study design.

I'll take a moment to remind you of the student statistical analysis play in Pristina.

First expected in the second half for next year, we will see the results of Rebecca motto therapy versus placebo in all study population.

And then probably a year or more later, we will see the results of <unk>.

Versus Rebecca you know study populations.

In each of these analyses, we will first evaluate outcomes in the H.R.D. population, including Braca, and then stepped down to the entire in temp to treat population.

To wrap up rack and moved to sit nibble described see star our coldest sponsored phase one beep to study that includes multiple single are Rebecca combination studies.

Putting the combination of Rebecca what it says it says Matt Cooper Tieken now known as <unk> for the treatment of advance by the static triple negative breast cancer relapse platinum resistant ovarian cancer admitted static eutillio cancers <unk>.

Separate arm up see certain cruise the combination of <unk> public tumors, which is currently in the dose finding things wouldn't be portion of the study.

Well <unk> of course is our investigational inhibitor <unk> tiny says, including best <unk> growth factor receptors 123.

<unk> goes back to receptors Alpha and beta and fibroblast <unk> 123.

In February 2019, we in Bristol Myers, we've expanded our technical collaboration to include planned combinations of old people with the sitting at.

Well the sponsored Leo one study use a things wouldn't be to study evaluating the sitting in combination with those people.

The one is now enrolling patients with it then solid tumors in the phase one b. portion of the study.

We anticipate submitting abstracts for presentations at a medical meeting in the fall of 2020.

Lastly, the B.M.S. sponsored Checkmate 79, X. study is a phase one to study evaluating multiple companies from but those people, including an arm and companies with who's sitting there in patients with second <unk> lung cancer.

Sort of activity for the Checkmate 79, X. study are proceeding.

Regulatory guidelines for clinical trial conduct during cold good thinking.

We were doing very enthusiastic about our peptide targeted radiopharmaceutical therapy program and in particular lead compound F.T.P. 22 86.

F.T.P. is highly expressing can sort associated fiberglass or caps, which are found in the majority of cancer types potentially making it a suitable targets across a wider range of solid tumors.

Highly express in many appeal, you'll cancers, including more of a 90% of breast lawn colorectal and pancreatic carcinomas.

Recent preclinical data in animal models, which we expect will be reported added upcoming medical meeting has only increased our optimism around this program.

In addition, we in three D.P.R. collaborating on the discovery program director the three additional targets for region by therapy, which we have global lights.

We were going to this program for many reasons, including of course, the opportunity to be a leader in the emerging field of targeted radio therapy for the treatment of solid tumors.

In this case, we have the opportunity to be the first to clinically develop an F.A.P. targeted radio, but and we also enthusiastic about the targets other subject call a plane or or ongoing discoveries collaboration.

Well. It was currently planned to submit an investigation will do drug or I.M.D. application for I.P.P. 22, 86, and the second half of 2020, followed by a phase one study to determine the dos and Colorability, a B.S.C.P.U. targeting therapeutic agents with extension cords, playing the multiple tumor types as part of the global developed.

Program.

Thus far in radio therapeutic development.

Positions abuse, an imaging agent to identify patients with the appropriate level of tumor targets in our case F.T.P.

Exploring opportunities to generate imaging data for I.P.P. 22, 86, potentially even before our I.M.D. is submitted.

Only with this information be useful to gain additional experience with that they'd be 2026, and better understand the characteristics of S.A.P. expression and multiple tumor types.

Further would allow us to collaborate with other academic institutions eager to explore the potential of S.A.P. 2026, as an imaging and as a treatment modality.

And with that ultra Nicole over to Dan to discuss first quarter 2020 financial results.

<unk> Hello, everyone. We recorded net product revenue from Nebraska 42.6 million for two 120, 20, which included U.S. Nip chronic revenue, it's 39.3 million and next U.S. snapped product revenue.

3.3 million.

This represents a sequential increase of 8% over two for 2019 net revenue like 39.3 million and a 29 per cent increase over q. on 2019 that product revenue 33.1 million.

U.S. Snip product revenue was 39.3 million for the first quarter of 9% from 36.1 million recording queue for 2000 nights, we ended up 23% from 31.9 million recording Chew on 2019.

Supply of free drug distributed to eligible patients in the U.S. through the rim brackets patient assistance program for coupon 2020 was 12% of overall commercial supply compared to 18 per cents in Q. for 2019.

Represented 5.6 million in commercial value for Q1 2020.

Compared to 8 million in cute for 29 too.

We can't yet predict the impact of coping 19, and and and related unemployment on Pap utilization over the remainder 2020.

X.U.S. near product revenue is 3.3 million for the first quarter of 2020, which represents a slight increase over the 3.2 million recorded for Q. for 2019, and the 1.2 million reported in the first partial quarter backs U.S. sales 212019.

We launch for bracket in France, and Spain. During March 2020, So we only expected a small contribution to keep one for those countries.

We have now recorded product revenues of each of Germany, United Kingdom, Italy, France or Spain.

We expect to launch into additional smaller European markets over time.

<unk> adjustments totaled 22.6% and Q. on 2020 compared to 17.4% in Q. for 2019.

A sequential increasing breast and have adjustments reflects primarily an increase in the U.S. contracting and government related programs and the impact of growing European sales, but generally have higher G.T.N. rates.

We expect breast and have adjustments to remain in this low 20 per cent range, depending on revenue distribution mix for the U.S. in Europe.

The number of weeks and distributor inventory was flat tippy end up coupon versus before so there was no build up inventory as a result.

Action to cope with 19.

At this point in time, we have nowhere choose with either drug supply word distribution of drugs to the patient.

We have described product supply costs as a meaningful part of our camp spend over the last couple of years as we transition to a new manufacturing facility. So we're in a paper both position for some time to come.

Turning out to a discussion of cash as of March 31st we had 228.4 million in cash cash equipped lunch and available for itself securities.

In January 2020, the company, we purchased 123.4 million aggregate principle amount of it's 4.5% convertible senior nodes do 2024 that were initially issue in August 2019.

Oh 2020, the company exchanged approximately 36 million in aggregate principle amount of it's 4.5% convertible senior notes do 2024 in exchange for approximately 32.8 million and aggregate principle of 2021 notes held by such <unk>.

It may 2020, a holder if the 4.5% convertible notes do 2024 converted 24.3 million part, though you with notes into approximately 3.3 million shares of common stocks are the standard terms of the inventor.

Following these transactions approximately 64.4 million aggregate principle amount that these 2021 notes remain outstanding and approximately 150.6 million in aggregate principle amounts of these 2024 notes remain outstanding. Additionally, the company has 300 million aggregate principle amount of it.

I was standing up at 1.25% convertible notes do 2025.

As a result of the transactions noted above the company is reduced its total outstanding convertible debt by 145.1 million and outstanding principle amount from December 31, 29th June roommate 520 20.

And as of March 31st we had drawn approximately 50 million under the T.P.G. Edina clinical trial financing and had up to 125 million available to draw near the agreement to find the expensive there'll be at the end a trial for two 320 22.

Based on the company's anticipated revenues spending available financing sources, an existing cash cash equivalents and available for sale Securities. We believe we have sufficient cash cash equipped ones and available for sale Securitys to ponder operating plan into the second half a 2021.

Not include any cash repayment that may be required to pay off.

We refinance earlier, the remaining 64.4 million aggregate principle amount of the 2.5% convertible notes at their maturity in September 2021.

While we did not see an impact in q. on on our revenues the effects of cope with 19, a future sales are difficult to assess or predict and we may see some near term impact on revenues related to cope with 19.

Metcalf shoes, and operating activities with 82.5 million for Q1 2020 compared to 98.5 million per Q1 2019.

In addition borrowings under the T.P.G. it being a financing provided 15.6 million and cash and Q. on 2020, reducing net cash utilized in operating activities to 66.9 million during the quarter.

<unk> and operating activities for Q1 2020 included products supply costs of 12.4 million and once a year annual incentive compensation payments.

We expect products supply cost will be significantly reduced from this first quarter level for the remainder of 2020 and at least the first half with 2021.

We also expect significantly lower cash burn in the second half of 2020, assuming achievement of our plan revenues over that time frame.

We recorded a net loss for Q. on 2020 at 99.3 million or one dollar and 39 cents per share compared to wouldn't have lost for the first quarter of 2019 86.4 million or $1.63 cents per share.

Net loss for Chew on 2020 included Sharebased compensation expensive 13 million compared to 13.6 million for Q1 2019.

Research and development expenses total 68.2 million for 21 2020 compared to 62 million for the first quarter 2019 increases primarily due to higher research and development costs for bracket clinical trials.

We expect research and development expenses to be lower in the full year 2021 compared to 2020.

Sewing generally administrative expenses total 42.6 million for T., 120, 20, compared to 47.8 million for the comparable periods in 29 too.

So in general and administrative expenses decrease during the first quarter of 2020, primarily due to decrease commercialization expenses for Braca and the U.S. and Europe.

We expect savings et cetera, selling generally administrative expenses as a result of the big hope it 19 situation globally.

Lastly, we continue to explore ways to improve our balance sheet capital structure and except for cash balance beyond the second half of 2021.

As noted, we expect R. and D.R.R. and B. expenses to decrease in 2021 compared to 2020 S.G. that expensive trippy lowering the upcoming months then we expect there will be in line with the T. 120 20 levels through 2021.

Are inventory purchases another non recurring milestone payment expenses bull significantly decreased route 2021.

And we anticipate planned revenues to increase with broken all geography, and with our anticipated prostate indication recruitable at launch in the U.S.

All of these factors should contribute to a reduction of quarterly cash burned into and through 2021.

Back to your path.

<unk>.

In summary, we're pleased with our progress in the first quarter and we believe that were bracket as well positioned to the maintenance therapy of choice for the current ovarian cancer patients and you're cute and then the coming chronic cobin 19 environment.

Positions will continue to seek to reduce patient visits there clinics and Rebecca upper certain advantages to achieve this goal.

Bracket is in a rural even delivered to and taken at home.

<unk> has been shown to extend the progression free survival by independent assessment by nearly 14 months on average compared to placebo or observation, which is shown P.F.S. of only five months on average.

And Rebecca requires only monthly routine monitoring plus limiting patient visits to the kind of.

We believe these qualities opera compelling argument for Finnish and still consider Rebecca and the maintenance setting per current ovarian cancer.

And soon we hope to offer a new therapeutic option for <unk> for current met a static castrate resist prostate cancer patients in the U.S. as well.

We remain focused on managing our net cash utilizing operations and improving our balance sheet to convertible debt and other transactions such as the transactions, which occurred in January April and May have this year.

And last but certainly not least I'd like to acknowledge our employees all of whom they've been working from home since mid March and I'm grateful for their ongoing commitment to support patients health care providers and each other during this challenging and unprecedented.

And with that were.

To answer any questions you may have.

Hi, <unk>. The question is pressed star one on your telephone keypad <unk>.

Your first question comes from <unk> RBC capital markets Caroline It's open.

Hi, Thanks for taking the clustering in dark forgotten upon the operational progress. Despite the panic. It seems like maybe you really half Hudson.

From but covered pandemic going on obviously arising from some of the decreased.

There should be on the language Department can you maybe talk about how they could read through to to prostate cancer given some of the alternative agents with the chemotherapy if they're out there Uh huh, maybe even more <unk>.

Yeah, if you're aware both s. going if you have encouraged <unk>.

Positions to consider oral therapeutic.

As they as they consider treatment options for patients and and obviously, we hope and believe that that will continue to a keyboard advantages I discussed not only in the ovarian cancer setting versus certain alternative infusion based products, but versus immunosuppressive chemotherapy and.

Prostate cancer.

Kenneth Your next question.

Oh, Okay yeah.

Next question, what's been done away with Barclays <unk>.

Thank you for taking my question.

<unk> differences in terms of a cold in most <unk>.

Lunch and also.

Yeah.

Sure.

Shall we actually Hmm Hmm Hmm quite.

Yes, so first as a geographic differences regarding the lunch.

Yes.

We we it's pretty evident that for instance, you know the New York Metropolitan area has been hit pretty hard.

And I I think we probably did see an impact on on sales.

At least new patients starts in New York, Yeah, maybe even during the quarter.

As to the to the prostate cancer lunch.

There will likely be some hot spots where.

Distractions to the health care system occur and couldn't temporarily impact on prescribing.

I will say that we could produce the data may 15th and being prepared to launch on or before me 15.

We absolutely what to expect to see sales in prostate cancer in the second quarter, well I'm six weeks upstate.

Okay. That's very helpful. If I mean, just squeeze Cuomo question any thoughts on that you won't approve wouldn't first line. Okay <unk>, how old <unk>, you know deacon public opinion scape anymore, Oh seating Oh.

<unk>.

So it.

So one it was totally expected and so it it came as expected and and they're approved.

It is not going to have any impact on her you know read out the trial is almost fully in the room. So we'll have no impact on enrollment obviously.

And and in fact, we don't even enrolling in the United States, We started shutting down.

Country by country certain areas and we've already shut down and woman in the U.S. So it they will have no impact on the timing of our read out for 14.

Thank you.

You bet. Thanks.

Your next question comes from Michael Smith, Guggenheim Securities, Hey, why not smoking.

Hi, Good afternoon. This is P.M. for Michael Thanks for taking our questions and <unk>, we got a few questions on <unk> commercialization prostate cancer.

The first one in terms of development up the companion diagnostic with partners.

I mean, the context of Kobe 1910, you may be talking about you know the leaders dialogue with pardon marriage in terms of advancing.

<unk> prostate cancer.

Yeah I I.

That would be uncomfortable talking about.

Any dialogue that our partner Foundation medicine.

Has ongoing with with F.D.A., especially if we get close to disapproval. That's more for them I think to comment on we certainly are aware as as all of us are.

But a lot of resources it F.D.A. both at at the Therapeutics Division and at the diagnostics division or or being directed to cope with 19.

But I think that I live in my comments to that we we we don't believe there will be any impact on our the timing of our potential approval and by our could do today.

Gotcha. Thanks, and then <unk> next one Wow, maybe so wants some launched in prostate cancer.

How how should be single sweet supplying their well we'd get more similar to all the Orient cancer, where should we think it differently.

There's a slightly higher percentage, we think of of Medicare patients just given the demographic of the population.

But we have as you saw in in Q1 have done an increasingly good job of managing that program now we as Dan said in his prepared remarks.

Maybe some impact on path.

As unemployment you know impacts on Uninsureds coverage for four people in this country, but.

But again that's.

Less likely to be for our.

Older.

Population.

Than it is for.

It is based or other individuals who suffered greatly and lost their jobs in this environment, but I I think that we have learned how to manage to back program and will continue to apply those learning trouble varying to the prostate cancer setting.

Thanks.

Squeezed that last question wants to confirmatory item three icing label <unk> used to either we ordered post chemotherapy in prostate cancer. So with respect to the sequencing I guess pays 10 40 interaction with conditions do you think we poop rock I should be fast.

Used to pre or post chemo maximize the benefit is pretty close.

No obviously you the owner in developer bracket I think it should be using just about everybody, but the reality is we we have evidence now a tremendous activity in the post chemo setting and that would be our immediate priority.

Gotcha seems very helpful. Congrats.

Your next question comes from Paul Choice with Goldman Sachs Caroline It's open.

Oh, Thank you and let me also offer my congratulations on on the commercial progress I have two questions and first you know just maybe to help us to think about the the outlook for for the remainder of D.R. give them the backdrop m. job.

<unk> <unk>.

The last hall, you're talking about maybe potentially offering up uptight and here I I well, yeah, but without in mind Q., maybe talk about you know how you think about but the <unk> evolving this year at crops and and maybe next year just given the the the changing landscape and more people you know struggling to have insurance and so forth.

And maybe just you know what you think reliance on Medicare and Medicaid My P. over the course on the remainder of the year and next year and then add a follow up with with a clinical question.

Yeah, I think most companies in this moment in time or are not very excited about giving formal guidance. You know we tried to give you directly how we think things are going I'll I'll turn it over to Dan to answer the pair mix question then.

Yeah. So.

Somewhat hard to predict I must say something like demographics buy into it as bad alluded to before so yeah within an area and we wouldn't necessarily see a much of a ship, but within prostate it it could have a different profile than ovarian.

I mean that could be with a higher age demographic that could be more you know part d. patience, which you know could potentially have some effect on G.T.N. and so I think that that's probably the the one area where he may have what would a bit more of a ship from regular commercial two two party under cross.

State.

But it's hard to predict any other you know changes around be ovarian section.

Okay. Thanks for that and then with regard to the the next set of of trials sport <unk> sitting there program.

You guys talked about having some some data presentations in the fall in the press release, maybe just confirmed <unk> confront cross if that means as mouth and then second as you think about <unk> recruiting for the next like outdoor what's the trials can you may be just you know help US you know sort of understand timelines where are you. What you would be you know <unk> because I think.

You should happiness or a dose finding ghana relatively soon and just you know how do you think about maybe you know potential next step some data read outs. After this upcoming data.

Oh, thank you.

Yep I would I would expect that we we will submit to as moment, we are targeting is <unk>.

Obviously, we don't even know if there's going to be an asthma or if there isn't as <unk>, almost certainly I think going to be virtual but they haven't said that yet.

So that's the the first dancer.

I would anticipate pending enrollment patterns that by either ask over at the latest as going next year, we'd have a more complete.

Presentation of the combination data.

Okay.

Your next question helps me pouring cosmos with J.P. Morgan wanted something.

I wasn't Gavin opera core you. Thanks for taking a question wish I'd want on the competitive landscape within prostate trying to get more expensive any updated thoughts on.

The launch and in the context going up against a computer with a potentially.

Label with randomized phase three data just trying to get your up updated thoughts I think you provided some last quarter, but but I mean update that would be great. Thank you.

Yeah, So a couple of things.

We're delighted that there will only be tool books.

Unlike ovarian where there are are three and we were the third.

With regard to their randomize data.

It's a very small study.

So it it doesn't have the power in the larger study and in particular the controller is control wherever that is proving to be extremely ineffective in this setting and so if anything they validated that their control armed isn't a very active controller. So I I think we can make these points are data stand.

Oh, we're very encouraged by our data.

We've got good responses back from conditions to our data.

And we look forward to getting out there we would prefer it will be glad when frightened three reads out and we haven't earlier line a therapy I do expect as as a question got I sit there maybe some use earlier just given the fact that it's an oral agent.

And positions they try hard to get that earlier land use.

Great. Thank you.

But.

Your next question comes from <unk> made with banks America.

<unk>.

Hi, guys think I take when my question <unk>, maybe just a a click one on the on the pop program I know you've answered a couple class sounds on that's already but can you just talk about the dynamics that helps to improve the trend that you saw between four q. 19 them on the first quarter on the up.

Program on on I have a quick question I'm plastic.

Yep. So one is as you may.

Remember the the the funding the independent funding of these foundations that can provide kobe support is highly variable.

That funding was.

It was a good quarter in terms of foundation funding in Q1, so that always has an impact when when the patient easily get access to the Kobe.

We have taken some some other steps Oh, I don't get too far into the weeds, but to ensure that before a patient is enrolled in <unk>, Oh, Oh opportunities are exhausted.

Tournament, if they do have sufficient insurance to to to get that co pay main extend in particular.

<unk> are provider.

This path.

Service in rules or pay for them and they refer patients for a benefits review. So one of our specialty pharmacies, who are who are adept at evaluating that that benefit.

Package. So it's just some logistical word plus better funding to the foundations.

Okay.

So that color number one question on possible since its launch isn't mentioned at the beginning is going to be fine you know, mostly not all let me finish telling for personal contact quaint.

Would it be a reason about the things that you could potentially make more points of contact complaints adore targeted sufficient.

Rather than the tennis all approach, where you've got you know puts on the grounds were what sales people trying to see a doctor some person I thought there might like one thing about it.

Yeah, I've I've I've thought a lot about this not only in the context of the prostate lunch, but but just managing our ovarian business.

And I don't think anybody would would say that.

That we don't prefer.

Personal contact you know office visits to to many people within the clinic, obviously the position of the pharmacist administaff et cetera.

That being said.

It's it's a lot of car travel in some cases plane travel and it's pretty limited to the number of people, we can see and we've talked a lot about the fact country you've heard this from other companies that we are we are absolutely.

Directing our our team encouraging are keen to reach beyond.

You know those who we know are known.

Prescribers up Rebecca or likely to prescribe <unk>, if and when somebody at the prostate approval and I I think it is reasonable to assume that we will reach more customers.

With a little less wonderful way of reaching them that is digitally and electronically maybe a phone call resume rather than in office visit but I I agree with the.

But the premise your question, we should be able to reach for people.

The next question comes from Andrew buried with pets, Phoebe for a long it's open.

Thanks, maybe one on the curb it impacts on a quarter and one on the balance sheet.

The <unk> some companies that there's been stockpiling, that's created pale ones for a number of cancer drugs. I was just wondering have you guys standing up to give them. The 90 day back the scripts.

<unk>.

We have had.

Are scripts or 30 days, we had 11 patients 11 patients in the quarter who've got greater than 45 days.

Oh, no we see no stockpiled.

And and second car inventory levels were flat to down.

From the prior quarters. So there was also know stockpiling by our distributors are especially pharmacies.

Okay.

I know you previously suggested that you could monitor sitting there I was away the less than the cops in debt overhang.

How you think about that opportunity now with the data potentially coming by your.

The corporate environment.

Well you you still see activity in the corporate environment admittedly people are trying to get used to how to be active in the coping environment. When I have talked about that and I definitely have I've suggested that stuff is more likely to be at 21, you been as not only safety at other data number you know emerged from where we have enough patients treated that.

Any potential partner could make a reasonable comparison with all of the you know caveats associated with cross trial comparisons.

Yeah, but a competitor combination, which is pembroke plus one back in there. So I I wouldn't I would be hoping for something like that and 2021 not not expecting it in 2020.

Okay. Thanks.

You bet.

It doesn't if you'd like to ask the question is pressed star one. The next question comes from at White with H.C. Wainwright Carolina tipping.

Hi, Pat Thanks for taking my question.

So you had mentioned <unk> and you know about patient monitoring and perhaps and they do a treatment paradigm with with <unk>.

That <unk> might have a lake up on that I'm, just wondering if you're hearing anything about the use of a bad thing in second line maintenance as far as confusion you know every three weeks in the meeting weekly monitoring. That's also you know perhaps not favorite than the current environment and then also you know just thinking again about the market.

Share, but back then you know if if you have any thoughts on the market share with <unk> second why versus the park versus observation thing.

Yeah, we we think first of all.

We had one position come to us and say that she had a number of patients on a vast and maintenance when she was converting all of them to Rebecca.

And I I think that's an anecdote, but I think reflective of the concerns people would have about a vast and not only that it's an infusion product requires you know what a visit to the clinic.

But you know there there have been three primary cool morbidities associated.

With Cobin 19 is a real risk factor, that's diabetes obesity and hypertension and the green three four incidents hypertension out of that is pretty hot in positions are well aware that you know how to manage it and have been able to manage it easily but they're probably a little more nervous in in an environment. So cold that so I I think it is going to have an impact actually.

I mentioned that it might.

Repaired remarks, but I I think we are going to see some advantages there.

A lot of a bass and uses in front line, but probably about 20 to 25 per cent of patients get a vast and in a second line maintenance.

Hey, thanks.

Yeah.

There were no for their questions by trying to call back to enter pretty close remarks.

Okay.

Every one for your interest in clinical psychology today.

If you have any hollow question you can call me at three or 365 entitled to channel or Brianna transferring 65 kind of country. It's called can be accessed via we play on our website beginning in about an hour it would be available for 30 days.

Again, we appreciate your interest in time, you can have a good day.

[noise] Goodbye.

Different Blue States Conference call you may know disconnect.

[music].