Q4 2019 Earnings Call
Good afternoon, and welcome to the Chemocentryx fourth quarter and full year 2019 financial.
Results Conference call at this time, all participants are in listen only mode. Later, we will conduct a question answer session. As a reminder, this conference call will be recorded I would now like to turn the call over to Bill Slattery Burns Mcclellan Mr. Slattery. Please go ahead.
Thank you.
Good afternoon, and welcome to the Chemocentryx.
Fourth quarter and full year 2019 financial results conference call.
Earlier this afternoon the company issued a press release, providing an overview of its financial results for the fourth quarter and full year ended December 31st 2019.
This press release, along with a few slides that you may find helpful.
Oh, you listen to this call are available on the Investor Relations section of the company's website at Www Dot Chemocentryx Dot com.
Joining me on the call today's Dr., Thomas Schall, President and Chief Executive Officer, Chemocentryx, who will review the company's recent business in clinical progress.
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Following his comments Susan can I executive Vice President Chief financial and administrative officer of Chemocentryx will provide an overview of the Companys financial highlights for the fourth quarter and full year 2019 before turning the call back over to Tom for closing remarks.
During today's call.
Well, we will be making certain forward looking statements, which of those of you. Following the slides can see if you look at slide two.
These forward looking statements are based on current information assumptions and expectations that are subject to change and involve a number of risks and uncertainties that may cause actual results could differ.
For materially from those contained in the forward looking statements.
These risks are described in the company's filings made with the Securities and Exchange Commission, including the company's annual report on form 10-K to be filed on March 10 2020.
You are cautioned not to place undue reliance.
Hands on these forward looking statements and Chemocentryx disclaims any obligation to update such statements.
In addition, this conference call contains time sensitive information that is accurate only as of the date of this live broadcast March 10 2020.
Most centrix undertakes no obligation to <unk>.
Revise or update any forward looking statements to reflect events or circumstances. After the date of Thislife conference call.
At this time it is my pleasure to turn the call over to Tom Shaw Doug.
Thank you Bill and good afternoon to everyone listening. Thank you for joining us on our fourth quarter and.
Full year 2019th conference call.
In 2019 world witnessed the tectonic shift for our company.
That is we drove events of massive significance for the patients we seek to serve.
For the clinicians who also toil on their behalf and for our shareholders.
Today, let's focus first in part on how this happened, but more importantly, what it means in the advancing of our unique programs to even greater values.
Our discussion today might be called a tale of two compounds that is our narrative surrounding two novel medicines the unique proprietary orally.
Administered small molecules known as a backup pen and CCX 140.
These are overview didn't slide three.
This title is apt and so far as we will discuss the achievements and progress in these two programs and then talk about what will happen next with a Buck Opana TCX.
140, including potential future disease indications in the expansion of utility of uncle parent.
But the title is also somewhat didn't complete because we ought not to stop there with the buckle pen and 140, Indeed I will close later by reminding that's all that there isn't it.
Tire pipeline at Chemocentryx not just in these two novel medicines, but in other innovative work that feeds a robust clinical pipeline in an expansive value luck landscape of the near future.
To begin last quarter in a stunning results for a pivotal.
<unk> phase three clinical trial topline data from the advocate study in anti neutrophil cytoplasmic autoantibody or anca associated vasculitis revealed that a bumper pen achieves superiority over the daily steroids containing active comparator standard of care therapy.
In sustaining remission in patients with Anca associated vasculitis over 52 weeks of treatment. In addition to showing a wide range of other benefits, where the backup and that we're not seen with the incumbent standard of care.
Yeah, Mark the advocate results are remarkable in.
Any ways, some more nuanced, but perhaps no less important than others.
For example, the advocate resolved validated our pioneering approach it chemocentryx that oh highly selective chemoattractant receptor in ambition for the treatment of human.
Sure I'm unit inflammatory disease.
Specifically to my knowledge, the advocate trial with a Buck a pan is the first demonstration of a chemoattractant receptor inhibitor for autoimmune and inflammatory disease to show clear clinical benefit in a worldwide.
He center randomized controlled blinded pivotal trial.
And this provides profound validation that a highly targeted therapy.
With Precyse inhibition of a single chemoattractant receptor target.
Can lead to real Boston broad clinical benefits.
In a complex human patient population with a complicated auto immune disease.
For those longtime aficionado shows an enthusiastic who've been following this field for some years or even decades I suggest we now pause and pay a moment of respectful silence for the grateful demise.
Of the so called redundancy theory.
Yeah, now stay well buried in the past.
These results validate the rest of our pipeline approach and again all due to that at the end of my talk.
In a moment I'll come back to Avago pen and Anca vasculitis. Another diseases. My other focus today as I mentioned.
We'll be on our next lead drug candidate another unique asset known as CCX 140, Gtx 140 isn't inhibitor of the chemo kind receptor known as CCR to which we are now studying for the treatment of patients with focal segmental glomerulosclerosis or if that's yes.
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TCX 140 has an extensive and increasing scientific support behind it as well as a previous successful phase two trial in diabetic nephropathy.
We now entered this year up 2020, with an unprecedented clinical momentum as we prepare to deliver on our twentytwenty.
Our site plan that is our plan to announce topline data from for further clinical trials, all of which involves either avago pad or CCX 140.
Coming back to a buck a pen and Anca vasculitis, an orphan disease, where clinicians and patients.
Our desperate for a modern remedy as you can see from slide four.
The current standard of care, which we used as an active comparator in the advocate trial includes high doses of daily steroids, such as prednisone or mental prednisone combined with an immuno suppressant such as right.
So now before cyclophosphamide.
This standard of care treatment regimen must be restricted an actual clinical practice, just six months because of the significant mortality and morbidity. It causes contributing strikingly to the nine fold increase mortality risk for Anca vasculitis.
Patients as compared to healthy people.
It is high time for a new treatment paradigm and we may now have the answer.
The result of the advocate trial surpassed all of our expectations and could marked a critical turning point in the treatment of this devastating debilitating.
And life threatening disease.
The avago pen value proposition that we tested in the advocate trial was four fold as shown on slide five.
One.
To stop the acute active vasculitis crisis, and then could patients by stifling the activation of disease.
The neutrophils. These neutrophils are thought to be driven by the C. Five a receptor which is the molecular target of a buck okay.
Two by using a backup had instead of chronic daily steroids to eliminate illness is caused by the current standard daily steroid therapy.
Three just stopped the accumulation of organ damage, particularly at notably in the kidney.
And for to improve the all too often miserable quality of life of anchor patients.
Let me briefly summarize the topline results, which you can find on slide six.
First you will see that Avago pen was numerically superior and statistically non inferior to the daily steroid containing active comparator at 26 weeks in achieving remission that is in stopping active vasculitis add as measured by the Birmingham vasculitis activity score or be bass, which was the.
Tool use for the primary efficacy endpoints used in this trial.
After 52 weeks of treatment you Buck a pen therapy sustain remission at a rate of 67, I'm, 65.7% compared to 54.9% and the active comparator arm.
Not only.
Does this numerically and statistically non inferior to the income in standard of care, but this result was highly statistically significant for the superiority of Avago pen in terms of sustained readmission after one year.
Next avago pads achieved statistical stuff.
Physical superiority and reducing the illnesses that are associated with the use of steroids in the active comparator treatment as compared whereas measured rather by the glucocorticoid toxicity index, a comprehensive quantitative scoring system developed by expert clinicians over the course of some years.
Yes.
Third Avago Pan showed a statistically significant improvement over the active comparator in estimated glomerular filtration rate the or EG fr. While our goal was originally to stabilize kidney function to save the kidney it looks as though with Avago pen.
Kidney function actually improves.
Perhaps is the single data point that Nephrologist, our most interested in and it has been a key factor as we contemplate future opportunities for Avago Pan of which I will speak momentarily.
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Finally, you can see that Avago pen therapy was numerically superior to the active comparator standard of care in all 10 of Tim the measurements and at each of the time points measured while showing a statistically significant improvement in six of the 10 measurement categories assessed by the S. F 36.
Validated quality of life instrument.
Moreover, as I could pen was also statistically significantly better in the European Index Euro Qual five D. Five L.
Avago pen DUS demonstrated the ability to actually improve the quality of life over one year of treatment.
Her to a deterioration for those in the day. These Terry could Terry containing active comparator arm, a remarkable change and outpatient perceive and report their health with an instrument validated by regulatory authorities.
Avago pen superiority here includes physical and emotional functioning including a significant.
Took an improvement in the crucial category of vitality, which is so important in allowing patients to return to normal lives with obvious socio economic benefits.
The topline safety result results revealed an acceptable safety profile in the serious and life threatening disease with fewer subjects.
Having serious adverse events in the backup and group then then the daily steroid containing active comparator.
Putting this all together, we believe a backup Penn has a very strong value proposition as it demonstrated progress in all four key elements of the total burden of disease, which leads thousands of lengthy.
Two thousands of lengthy hospitalizations, each and every year.
We aim to share full advocate phase three data at the annual meetings of the European League against Rheumatism, or you Lar meeting and also the European Renal Association European dialysis and.
And association or era, he DTA meetings in early June of this year.
We intend to also for several refereed full publication publications beginning to be published this year.
We have assembled an impressive team of internal and external regulatory experts.
And are on track to file R., and D.A. or new drug application with the U.S.F.D.A. in mid 2020.
Our partner in Europe, Vifor pharma expects to make a regulatory submission to the Europeans medicines agency later in Twentytwenty.
We have chemocentryx.
Our gearing up for the anticipated commercialization of uncle pen in the United States, where we own a 100% of the rights well Vifor pharma does the same for international markets in an alliance in which we benefit from excellent economics with team to mid Twentys royalties on aggregate next.
Sales in the Vifor territories.
Although the commercialization opportunities here in the U.S. is very large it is eminently feasible for a company of our size because of the limited number of rheumatologist and Nephrologist, who manage the bulk of the patients with any to.
See it Didnt vasculitis.
We envision a field force in the range of 50 to 75 people as depicted on slide seven we expect normal orphan drug pricing for Avago pen and Anca vasculitis, reflecting the potential clinical and pharmacoeconomic benefits of this.
This medication for patients and for health care systems.
I'll turn now to our second unique asset CCX 140, which is generating a lot of interest among clinicians and other members of the community.
TCX 140 is a.
<unk> inhibitor of the Kiva kind receptor known as C. C are too.
CCX 140 is now being studied in the treatment of focal segmental glomerulosclerosis, an orphan kidney indication with no approved therapy in which the kidneys filtration units the glum area lie.
Develop scarring, which can lead to end stage renal disease.
Fscs patients have excess protein area or protein in the urine due to the breakdown of the kidneys filtration system.
CCX 140 has an excellent clinical pedigree.
We published.
The paper in Atlanta, diabetes, and endocrinology, a few years ago, showing the results of a randomized double blind placebo controlled 52 weeks continuous dosing phase two trial of CTX 140 in more than 300 patients with diabetic nephropathy or diabetic chronic kidney disease.
In that study CCX 140 achieved a statistically significant reduction in proteinuria, which was the primary endpoint. It exhibited a good safety profile and was well tolerated.
Since that trial, New science has reinforced our hypothesis that ccrtwo inhibition is effective.
In protecting photos sites and improving kidney structure infiltration with the latest new science being presented in post reform at the 2019 meetings of the era, we are a DTA meeting and the American Society of Nephrology.
For example, Ccrtwo inhibition.
Vision provided significant and rapid renal protection in murine models of chronic kidney disease, including both diabetic nephropathy and non diabetic models, such as Fs G.S. models.
In fact, these beneficial changes can be seen even at the visual level at least.
By Elektron micro microscope analysis slide eight for example shows in Elektron Micrograph, you made by CCX scientists would show striking improvements in the integrity and structure of the specialized filtration cells of the kidney the photo sites.
Which tenderly rap.
The extra vascular surface of the capillaries in nickel them aerialists or filtration unit of the kidney.
You can see the difference in the photos sites and nickel Mary lie when Fs G.S., resulting from a surgical consequence is inflicted in the model and when Ccrtwo inhibition.
It's been his is employed in these animals.
This inhibitor being a close analog of CCX 140.
In summary, the new science of TCX I strongly supports the photos site as the culprits and that Potus Act preservation via Ccrtwo inhibition suggest a likely.
For the decrease proteinuria in both diabetic nephropathy, and Fscs models and likely the diabetic neuropathy result, we saw in human clinical trials, which we believe should translate to human fscs trials as well.
So the alumina one illumina.
Two trials will assess TCX, one fortys ability to reduce proteinuria levels from baseline in human crime area first yes, and the FDA has indicated that proteinuria lowering NFS, yes could potentially be a registration endpoint for this indication.
These studies are outlined in slide.
Right.
The patient need is great. There are more than 100000 people in the United States believed to live with this affliction. There are over 5400, new cases of Fscs each year in the U.S.
And there are approximately a thousand.
Kidney transplants annually involving.
[noise] fscs patients.
We completed enrollment last year, a 46 patients in our alumina one randomized placebo controlled dose escalation phase two trial of CCX 140, and sub nephrotic primary STS patients. We are on track to report topline.
Flying data next quarter Q2.
The primary endpoint of the Lumina one trial is reduction in proteinuria at 12 weeks and secondary endpoints include estimated glomerular filtration rate.
We believe that we have also addressed to somewhat unusual dose response from the original phase two.
Diabetic nephropathy trial in which the five milligram once daily dose demonstrated somewhat better reduction in proteinuria, then did the 10 milligram once daily dose at week 52.
As explained in a November 2019 journal of Immunology report and 2019 era E T a poster.
Contagion from Chemocentryx scientists are data suggest that the antagonist the antagonists induce increase of the natural lot again can occur sometimes with the blockage of the clearance.
That lie again by TCR too.
We identified a sweet spot in terms of balancing potus I preserved.
Okay, and renal function versus MCP, one the natural again for Ccrtwo being produced by monocytes in macrophages and the body.
Our pharmacological data suggest that we can readily dose at levels. For example, the 15 Mig milligram twice daily dosing alumina trials to provide more than enough receptor.
Average to overcome the elevation of MCP one in the body in the presence of the Ccrtwo inhibitor, thus stabilizing prototype function.
The alumina one trial elevates doses from five makes once daily and 10 and 15 makes twice daily in order to test this finding and to best.
And to find the best dose over 12 weeks. The study. We'll also look at subsequent results. After the following 24 weeks and as I mentioned results from them on a one are expected in the second quarter.
The alumina two trial next is a single arm open label clinical trial.
Now with more severe forms of primary fs, yes. In fact, those with the frantic levels are proteinuria, which is a rare condition patients will receive doses escalating from five milligram. Once a day to 15 milligrams twice a day and we expect topline results from them in the two later.
This year and Twentytwenty.
The Illumina trials are part of our Twentytwenty Force I plan to report topline data on for clinical trials in 2020 as displayed in slide 10.
As I just mentioned two of these are the alumina one in them and the two trials and the other two trials involving.
All of Avago Pan.
First as shown on slide 11 is the accolade trial of a life threatening complement dysregulated orphan kidney disease for which there are no. There are no approved treatments C glow marry a lot the fee or C. G.
Half of.
All see three g. patients experienced kidney failure and relapses, even after kidney transplant are also all too common.
Compassionate use cases showed that a backup on action on the Cfivea receptor could have a positive effect on this disease stopping the activation of the.
Destructive neutrophils, which are known to be precedent in C. Three g.
So we initiated the accolade trial and in 2019, we were awarded a $1 million grant by the U.S.F.D.A. to support that trial.
The primary endpoint is based on changes in the C. Three g.
Histological index following six months of treatment.
There are two placebo controlled blinded strider and the trial the high complement strat them is nearly fully enrolled and we expect topline data by the end of 2020, along with some data from the lower complements draw them.
As well.
Turning to the Aurora trial, and if you'll turn to slide 12. This features a backup pen and the treatment of a disfiguring skin disease, hydrant, itis Super Tivo or H S.
This disabling autoimmune conditions isn't neutrophil driven disease in which the complements system has been.
Okay did.
A buck uptimes proven ability to target the cfivea receptor and stop C. A neutrophil activation offers strong potential here.
A backup on its mechanism of action is designed to both the door before the activated neutrophils can escape.
And patients will be assessed after.
Weeks of treatment with the hydro notice Super Teva clinical response or high score clinical instrument.
We are closing in on the 390 patients enrollment and we expect to report topline results in Q3 of this year.
The momentum success of the African trial in.
You for and the four additional topline data readouts expected in 2020 represent only the beginning of our plans to bring the benefit of chemo attractant inhibition to clinicians and patients.
And the advocate trial Avago pen demonstrated an effect in improvement.
Of kidney function as measured by the estimated glomerular filtration rate or EG fr.
And as you can see from slide 13. This opens up a number of very interesting expansion possibilities for avago Pan and renal indications characterized by complement activation and inflammation.
We are looking first for example that lupus nephritis, given the strong parallels with Anca vasculitis, and we will update you on our thinking in the coming weeks.
We believe avago pine is that the threshold of breaking through to become a franchise a pipeline within a drug.
Overall 2019 has set us up for an extraordinary year as we expect to execute the first of our new drug application filings.
Also our 2024 site plan of or topline data read outs.
And clinical preparations to broaden the backup pens indications.
All of this is fueled by a very healthy.
Financial position as Susan can I will now described.
We ended the year with more than $200 million on our balance sheet and since then added a non dilutive credit facility of up to $100 million more.
Susan.
Thank you Tom.
Our fourth quarter and full year 2019 financial results were included in our press release today and are summarized on slide 14.
Revenue was 10.1 million for the fourth quarter compared to 9.3 million for the same period in 2018 for the full year ended December 31 too.
Thousand 19 revenue was 36.1 million compared to 42.9 million in the previous here.
Research and development expenses were 9.2 million for the fourth quarter of 2019 compared to 15.1 doing the same quarter last year.
For 2019, as a whole R&D expenses increased to 70.3 million from 62.7 million in 2018.
These increases were primarily attributable to higher phase two clinical study expenses driven by patient enrollment and be a buck copan overworked trial.
In patients with H S and the two CCX 140, luminaire trials in patients with FX G.S.
As well as an increase in phase one expenses due to a buck apparent ancillary studies.
These increases were partially offset by lower research and development.
And drug discovery expenses in 2019 decreased phase three expenses at the advocate pivotal trial, which was fully enrolled in 2018.
General and administrative expenses were 7 million in the fourth quarter 2019, compared to 5.6 million we reported in the same period last.
Yeah.
Full year 2019, T. any expenses increased 24.2 million from 20.4 million in 2018, primarily due to higher employee related expenses, including those associated with our launch preparedness effort and higher professional fees.
We.
We recorded a net loss for the fourth quarter 2019 of 15.1 million compared to 10.8 million in the same period last year.
Our full year 2019 that net loss was 55.5 million compared to 38 million in 2018.
Total shares.
Outstanding at December 31, 2019 were approximately 16.2 million shares.
We ended the year with two had can didn't 2.2 million and reported cash and investments excluding the credit facility of up to 100 million, which we security in January.
Larry 2020, as Tom mentioned.
Lastly in terms of guidance, we expect to utilize cash and investment in the range of 85 million to 95 million in 2019 Tom.
Thank you Susan.
To summarize this.
As you can see from slide 15.
2019 truly was a breakthrough year for Chemocentryx.
As we reported top line data for our pivotal phase three advocate trial, showing superiority and sustaining remission at 52 weeks for Avago Pan over the daily steroid containing active comparator and accruing other benefits to a backup.
Okay and patients not seen in the traditional standard of care.
We plan to file and then da provocative pen and Anca vasculitis with the FDA mid year, and our partner Vifor pharma plans to submit a license and application to the E. M. A later in the here.
We invite for farm are preparing for commercialization.
One of the U.S. and international markets respectively.
We completed our enrollment in the alumina one trial of CCX 140, NFS G.S., which we expect to be the first of our 2024 sites series of topline data read outs, followed by read outs for Avago pen and.
Two more indications C to marry a lot pathie and hydro and I, just super Tivo and alumina two trial of Ccxone hundred 40 in a rare reform FSS pest, yes.
Our track record of strong execution gives us great confidence and has attracted the financial resources that enable us to.
We move forward on so many fronts simultaneously.
This bright future is enhanced by the prospect also of expansion of our clinical development into further indications with Avago pen and lupus nephritis for example, as a first likely a indication to emerge over that horizon.
In addition.
And I would be remiss, where I not to remind all of us that there exists a robust pipeline slide 16 were reminds us of that beyond Avago Pan and TCX 140.
Additional volumes, if you will to be added to the tale of two compounds I.
I look forward with relish in the near.
Future to be able to discuss details with some of these other value, creating innovations and novel medicines that the rigor and power of the CCX I approach is ready to an leach.
In closing some of your reminded of the industry of voyages sometimes storm.
But ultimately where we had a fair strong wind filling our sales.
Here now we find that boy edge has landed us on an untrammeled sure with a new dawn suffused in the Golden glow of opportunity.
It is here that we intend to build our new.
World of health and prosperity for patients and for shareholders alike.
With that I will now turn the call back over to the operator and I look forward to your questions operator.
As a reminder is asking question you need to press star one on your telephone to it.
Your question press the pound Keith please stand by we can probably Q and a roster.
Our first question comes from Steve seed houses Raymond James You May proceed with your question.
Good afternoon. Thank you have some a beautiful pros there Tom.
Wanted to.
Yeah I wanted to.
I don't want to distract from the pipeline you guys highlighted but I think it's probably through into asked about Corona virus. If I can just because obviously the situation unfolding in the market and in the World and Tom as you know, there's a literature implicating C five and acute lung injury in mice at least following infection with in fact Corona viruses and.
We are aware also have a company in China. This generating a C. Five antibody to testing Tobin 19, and just saw a couple of minutes ago Regeneron plans on starting a trial for kevzara So a different.
Inventory approach for the questions pretty straight forward I was just hoping if you could clarify if in fact, there is a coherent rationale for a back a pan.
I think over 19, specifically have you received any request or do you have any plans to test it.
In treating pneumonia associated with told we'd like to.
Yes, Stephen a great question in fact, as you know and others may know, but just to recap there is ample evidence that what happens and not just corona virus, but even other forms of severe violent.
Action.
In the cases that ultimately need to mortality.
There's a kind of acute respiratory distress syndrome, which occurs.
Cost of lung injury, which ultimately leads pulmonary failure and typically that as the cause of death in those cases that adult restaurant the acute respiratory distress syndrome is often accompanied by massive complement.
The activation and therefore, the activation of destructive granules sites, including neutrophils downstream a C fivei.
Interestingly as well and that's been shown in animal models as you say a various viral infections, there's a fairly good evidence in human beings as well there's fascinating evidence.
In certain individuals in China with a variant of.
C D 55, or the K accelerating factor, which the dysregulation of which can lead to greater complement terminal complement activation, including downstream of the alternate pathway, where cfivea receptor is found.
Those varian seem to be represented in.
Cohort of folks that experience high mortality rates consequent of a rds all that's by way of saying, yes, there's a very reasonable a hypothesis and it's still is a hypothesis at the moment that cfivea receptor. In addition might be able to help.
With advanced cases of Corona virus. The challenges are daunting as you know number one it is a hypothesis the timing of administration would be absolutely critical there's an argument to be made that all of these immune defense mechanisms early in the infection are what actually made control infection ultimately and the reason that.
In most cases, even the most cynical estimates of of survivability. The opposite the mortality is 95%. So one doesn't want to mess up the 95% survivability ratio. That's for sure. So we've done a lot of research. We are deeply looking at this we're consulting with experts all around.
A world about what might be done if we might employ some of our approach to assisting in this crisis. So it would be premature for me to say anything more than that at this point and we're just we need to continue to to sort of gather data and watch other crisis unfolds I will say to that.
You know, we do have a PEO drug and so sometimes the administration in the most dire cases can be difficult. So I'll work on Ivy formulations has been something we've been doing it for a long time, but we have not had any clinical validation yet of Ivy formulations. So.
As I said as as all of.
Bus, both internally and the scientific and medical World at large discover more about Corona, we're going to be right in the discussion and if we have more to say about that that's material well bring it to the community immediately.
Okay. Thank you for those comments and just back to the discrete.
And then Susan you mentioned an increase in phase one clinical study expense due to some of active in ancillary studies I was just hoping you can elaborate on what those studies include and clarify if they're completed or if they are still pending and therefore gating factors to.
The midyear submission.
Sure and I'll, let Susan handle that question.
Sure Steve now those are those are just an additional studies that were initiated Inc. Q4, and actually all complete. So now we don't expect testing to impact the timing of offline.
Okay. Thanks appreciate it guys.
Sure.
Thank you. Our next question comes from Edward Tenthoff.
The 5% you May proceed with your question.
Great. Thank you very much paramount thanks for the thorough update I'm a lot of recurring progress and I appreciate view reminding us of the works with sort of pipeline because I think there's a lot more to come and one of the Hooker Sim Alumina award and just get a sense or what you would see.
Positive outcome kinda understanding what your expectations and verticals might be and I'm curious to know just kind of looking at sort of the regulatory approach would you ultimately waits for ruminant to do the.
Or filing or will it.
Be sort of mixed up.
Ah works you have those business Hudson him. Thanks, so much.
Oh, Great question said, thank you so with limit to one NFS, yes first woods, it's important to remember there's just no currently approved drug for Fscs. So there's really no established benchmark or framework for success.
If we look at one of.
Our colleagues in the field is doing for example, those first sentence regulatory path, which comprises a subpart H accelerated approval process. If successful is based on the proportion of patients achieving us.
Are you PCR European I'm, sorry, [laughter] urinary protein creating ratio.
Less than a certain threshold in this case less than 1.5 grams per gram.
And ended up 40% drop or so enpro to know area at week 36, They will have to do a confirmatory endpoint base and percentage change in EG fr slope thereafter at a there's basically we.
On 12 or two years. So you know that's all informative I think that we know that we can.
Proteinuria drop at 12 weeks is something we we've seen in humans, we see really rapid drop in our animal models.
So anything approaching a 30, 40% drop you know above what we see with the.
Layering that's on top of standard of care, which are aces and arbs, which is how the protein will be read out. We'll we'll we'll have to have an addition to what standard of care provides would be very interesting to us and it would allow us to design. The next step of the lieu of the essentially the registration study, which will be a two arm.
Double blind randomized controlled.
With the optimal dose of 140 against just the the underlying therapy is not an conmeds. So that will we've already got that sort of design sketched out we think we know what it looks like we know how big it is.
Obviously will have very as soon as possible s.
And a one discussions with FDA to confirm what we think our previous understanding laws and in this trial design based on the results alumina, one and we hope that we can can find a quick path to registration at least conditional registration based in person or you're lowering.
[laughter] Fs the Illumina.
So with the products interim Fscs no it's not a gating item for proceeding with primary SGS you had certain special hopes for that and the products and <unk> population, including being able to enroll somewhere between six and 13 in fairly short order and maybe keeping them off.
The rescue steroid regimen, it's proven to be a very difficult trial to enroll these are really sick people and it's kind of an intense trial, because we watched them.
Well, we watch them very carefully for protein increases and as we step them up so I.
I would say that and I don't have any data yet.
From that trial by the way so it but certainly the nephrotic syndrome open label study is not a gating item two primary fscs registration in anyway, and I believe bulk illumina one in limits to results will support each other ultimately in the discussions with FDA.
That's really helpful isn't.
I mean, it's a quick one or a system it looks like maybe there was.
Jim draw down in the first quarter, just looking at sort of assert him from the 10-K versus your commentary.
60.2, so I'm curious did it took them some and can you give us some stimulus works and what the.
Tim utilization was during the first quarter and then secondarily Hum you access can be as 100 million dollar credit facility or so still a fully available thing.
Sure so to that could this be clear there is no ATM facility for equity distribution agreement.
Hey, he and the activity that you see there is primarily stock option exercises in the fourth quarter only 19.
So that is right to clarify than the source there for you.
In terms of <unk>.
Sure of course and in terms of de hundred million.
Credit facility again that being essentially available at our option for the most part I'm Fivenine was taken down a this month in March and the balance of the 20 million would be available can be essentially ended this year. The first right in the first time to ton.
We have another tranche of.
$20 million upon Andy a submission.
And then an additional 30 upon Nd approval, and then 30, Mary Mcgowan subject to credit approval. So it's fair to say, though that not none of that's been taken down as of this moment.
As I as I stated in the beginning just 5 million that won't be taken down later this month.
Great I can't think of Uh huh.
You're welcome.
Thank you. Your next question comes from Michelle Gilson with Canaccord Genuity you May proceed with your question.
Hi, Tom High season, Thanks for taking my.
Question <unk>.
I was just hoping to dig in a little bit more I choose Illumina. One study you Werent. What are you planning to report next quarter anything beyond the primary endpoint.
And then.
You touched on kind of the magnitude of the fact that you're expecting.
But should we also be looking for a dose response, especially at such an early time point at 12 weeks.
And kind of following this line of thinking and you got the on the call Tom but can you also elaborate on how you chose oh, he's dosing cohorts and the data that support safety as TCX 140.
And maybe remind us on why degrees of this study is appropriate for FX, yes.
Absolutely all good questions Michelle Thank you.
So the what we'll report we're committed to reporting the 12 week data, which is the three dose active dose arms versus placebo.
We may well.
Well again depends how how we can get all the data together appropriately, but there's a crossover at week 12 to 24 weeks additional open label and they all crossed over to the highest safe dose, which I'm delighted to say was the highest dose. So we might have some inflection kind of point data to share.
Well, we'll have to see how that plays out.
So definitely the topline data personnel reduction baseline change from zero to week 12, and maybe some things beyond that well. If you know it's a very short timeframe for any real change and EG fr frankly, and as you know it's a fairly small study so you're out there and that that sort of.
He is a factor in in the discussion of your other question. So would we expect a dose response not necessarily but we do have a sort of mixed measures a statistical analysis across all dose groups versus placebo, we would like to see maybe some trends of a dose response.
That would be interesting, but not perhaps not essential we'll probably end up going with the dose that's best tolerated and again, we have no tolerability.
Issue, so far the sextuplets selection of the dust was interesting. So we took as a base case, the five Meg once a day dose because.
That showed rapid and sustained proteinuria reduction and the diabetic chronic kidney disease study over 52 weeks. So they dropped very quickly we could detect significant changes in proteinuria by weak for certainly they were well established by week 12, and statistically different from the underlying therapy the stable doses.
Basin arms.
And they continue it was to sustain difference over 52 weeks at the five make dose as I said, there was some variation and what happened at 10, Meg once a day, we analyze that in the laboratory and that was all about again acquisitive rating the amount of endogenous lie again being released at slightly higher doses of the Ccrtwo.
Antagonist and dosing through that if you will so this trial, we said okay. Great. We understand this really well at the level cell biology, which we published at the level of in vivo pharmacology, which we've discussed so we translated that to this trial design and said, let's do five big once a day 10 make.
Twice, a day and 15 make twice a day and so those are the results that again will be reading out at week 12 in Q2, and no fundamental either validate or provide new light on the pharmacological in cell biology data, we have but the seismic once a day was anchored to the original DN study, where we we successfully at our primary.
Endpoint.
So I think those are most of your questions and again the data will be presenting will be both the mixed analysis of cumulative.
Cumulative separation with all the doses versus placebo control, but we'll probably be presenting some vignettes as well.
In other words, just spaghetti graphs of patient by patient data, which are sometimes in smallish trials as revealing as the statistical analysis and naturally will get safety topline safety as well and other other features that are relevant to the biological effect.
Okay, and then <unk>.
I also have a quick question on on covert team.
Is there any opportunity to make ivanka pan available to patients on early access basis.
In light of the current epidemic I know many patients are probably quite where are you given your high immunosuppression and especially probably.
As with respiratory manifestations of Anca associated vasculitis.
Yeah. It's a great question. That's one we've been discussing very very deeply as you know one of the complexities. We have as we we have an international relationship as well with a partner so.
Without going into.
Many details the the ability to work with Avago pen and in these kind of.
Extraordinary settings would have to make sure both parties all parties fulfill their relationship.
Negations to each other we're also we have additional complexities by being essentially finding a registration package right now which is kinda like.
Mike.
I guess it would have you had to give me [laughter] a less than perfect time I had to have a public health crisis, where you might want to do something extraordinary with your agent.
Yes, you're finding your first registration package would would not be my first choice or having said all.
We do again fundamentally understand the deep obligations that we might have a and if theres something we can do to help and do it in a way that's responsible unsafe.
We are going we will find their way, but again, it's it would be premature allows me to talk about any more details on that today.
Let's just say that we have a deep.
Hi, or to help if at all possible and and at the same time, we have to be extremely sensitive to the obligations to bank anca vasculitis patients as well, where we know.
Based on the data certainly that's our strong belief based on evidence that we can help those people save lives and Anca and we have two we have to be very.
The mindful of.
Trying not to do experimental medicine for example, a in a public health crisis, and you know unless we have really good reasons to believe that we can do that safely and have some hope of providing a benefit.
Thank you so much home.
Your next question comes from dig on how is actually Leerink. You May proceed with your question.
Hi, good afternoon. Thanks for taking my question Congrats on all the progress. So just wanted to touch upon the alumina studies and then maybe one for accolade as well.
So Tom if we go back to your prepared remarks, I think you mentioned that the.
The and highlighting the unmet need for FSC, yes in excess of 100000 patients in the U.S. someone the other companies have given a different number so just wanted to.
Make sure that I heard that right.
And in terms of trials going forward I know you currently running women are wanting to.
The compression.
Gave seems to be intensifying and you also mentioned Sparsentan, which is now in phase three so just wondering.
Do you envision any kind of expedited timeline is once you get phase three underway, assuming you get positive data and if so I guess, how should we think about the overall timeline towards reaching that and D.A. submission.
And then in terms of accolade on a similar vein I guess, you mentioned stride them want to stratum Chew was tried them one data expected by year end of 2020, and a little bit of strat into data by year end I guess when can we expect a full data from both strata and also is there any kind of.
As soon as to what the potential labeling could be if if you only presented stratum won a for these registration grade trial.
Yeah. Thank you dig on really insightful questions. So.
SSG, yes, the to the first point you were asking about a.
The.
Forgive me, you're asking about the numbers of the incidence and prevalence yeah you know its.
It's I think Fscs is probably one of those frustrating areas to try to get a real handle on this because the literature is difficult and it is highly variable depending on the source you read one of the.
Sources of variability is the distinction between primary and secondary F. SGS and so as as you know, but many people may not be aware of this assets, yes, it's not a disease, it's actually a histological sign of kidney damage. So it's one of these strange I call it an indication.
Because it is it's an indication defined by a historical fall just read out a very specific kind of read out and so that's already a little unusual.
But the second bit of unusual. This is that you you can have that lesion, so focal or segmental scarring.
So it merely means when we look at a tissue section slide under a light microscope in two dimensions, we have evidence for either localized regions of scarring and nickel maryalice or whole segments of the go Maris scarring. So there are different ways to get that right.
So the F.D.A. is very.
Our full how they define whats called primary Fscs primary SSG has is also kind of weird that means you either have a defined genetic lesion known to lead to this kind of scarring and the kidney.
And those are fairly rare, although not vanishingly rabbit fairly rare lesions.
Or there's no. Other known reason you should have these lesions. So it's kind of like a diagnosis of default or ignorance. If you will secondary assets, yes could happen in any one of a number ways. You can have a prolonged diabetes, a and high you know severe disease that can lead to kidney scarring. So.
Theres actually the likelihood in our diabetic chronic kidney disease trial or D. N trial of years ago that we had a few in fact, maybe more than a few a.
Number of secondary Fscs people in that trial, you can get it from drug abuse, you get it from viral.
Yes.
Infection et cetera.
Probably it doesn't matter, whether its primary or secondary in terms of the therapeutic effect. If you have an agent that controls proteinuria by modifying or repairing go to marry a lie in the specialized cells within the glum airline, which is what we think we're doing by the way.
[noise] then it doesn't matter, whether its primary or secondary but it will certainly affect the numbers. So we're trying to use fairly reasonable estimates may be conservative estimates of primary fscs in the U.S. because the regulatory authorities here in this country are very very clear.
That they want a separate out primary from secondary in terms of the potential to to license new therapies. So I think our hundred thousand or so and again I know, it's a fairly vague number is reasonable for primary SSG us in the U.S. and I know others might site.
A lot higher and there are some that my type lower if they're just counting the genetic lesion is their definition of primary.
But I think it's a defensible number for our purposes and certainly the purposes for regulatory discussions competition.
You're absolutely right I mean, I mentioned sparsentan for more than one.
They are a farthest along now in a phase three study.
They're agent is an interesting agent that both blocks angiotensin receptor as well as blocks the into thielen pathway. These are both nodes in the same kind of pathway in the kidney known as the Reno the renin.
Angiotensin aldosterone pathway are Ras pathway. If you will so they're taking multiple bites out of the same pathway and there certainly having a nice protein lowering effect.
At least that's my interpretation of their human data.
They have some problems with this to deal with a and these are.
Well known so ended feeling one inhibition.
Whether its sparsentan or other send tens of molecules are the same class.
Do tend to cause DEMA fluid retention.
Can manifest itself in many ways, but this is a big problem to be managed and particularly difficult to.
All situation because that's one of the things we're actually trying to control with renal dysfunction is try not to have fluid retention as you can as you can well imagine we've made and done comparisons are getting back to competition. We've done envied in house pharmacological direct comparisons between this.
Our Santana approach and the Ccrtwo inhibition approach, both will lead to a robust and rather a marked and rapid proteinuria reduction. The difference is that we do not see any of the DEMA our pathways entirely different than the sparsentan pathway.
That may well allow us to.
Into the to the next part of your question that May well allow us enrolled the next trial the registration step of the pathway very rapidly because I don't think we're gonna have to battle. The resistance that one season. The clinic as patients are running into this fluid retention management issue, which we.
We think is.
Happening and the other approach I'm not concerned so much about the other competition again I think our pathway is.
Very very well differentiated.
We are explaining week by week, the mechanism of action and how CCR to controls distressed potus sites function.
How CCR too is a direct molecular switch that talks to the gloom area less about repair versus scarring function and we'll beach publishing more of that data this year very soon.
And in fact, the Tolerability of the agent continues to be excellent.
In humans. So I think that will do in fact, we'll do as well or or or better than our competition and enrolling trauson getting getting them done I won't prognosticate on timelines before we talk to the FDA. After our interface to meeting this year and then I'll come back to more with some of that on.
On that fest, yet so I think that probably covers the f. SGS questions.
You had one other question I am I am coming back to yes.
Right on the.
Very similar accolade, yes. Thank you. Thank you for reminding me. This is a really fascinating issue. So again no approved agents for.
Three going Merial apathy as you probably well no.
So there is no regulatory pathway number one.
There's precious little information about how to set up trial.
So we we developed a two strata approach and this was actually done in an interesting though rapid sequential.
Fashion, when we first data set up accolade, a little while ago day gone. So there was sort of the original reports from the experts and a couple of published papers again. This is a rare disease only about four to 5000 prevalent cases, maybe seven under do a thousand new cases in the U.S. per year. So there's not a lot of material to work with and not a lot of clinical trial literature.
Sure.
The idea that came out in a couple of really good published papers early on was a C. G which is again a kidney biopsy diagnosis will also have lots of evidence in the blood stream for consumed or activated complement therefore, the easiest way you can measure a.
Presumptive see three g. patients before you do a biopsy to confirm him or her is to actually say they have a lot of circulating Sci fi be through nine which is the soluble membrane attack complex, we use soluble membrane attack complex not because of any special reason other than it has a very stable marker.
In the periphery that's easily measured.
The activation of the complement Cascade write down through seat to the point of Sci Fi Bay, which is where we are on Cfivea receptor. As you know so that's stratum with the original approach to our accolade trial to arm study randomized control trial, where people had to have high levels of circulating complement.
Another couple of papers came out right after that saying well you know maybe it's not circulating complement that concerts, what's happening in the kidney. So maybe you shouldn't focus just on high levels of circulating that complex. So we amended our trial, we enroll the second stratum figuring we were alone in the world and having the ability to do.
To answer this question clinically with a randomized blinded controlled trial of some scale and a and a couple of different endpoints, including a heart endpoint of biopsy improvement after six months compared to a blinded control. So we enrolled the second stratum to your point so here's the deal first stratum is enrolled virtually.
Enrolled.
And those data will be really will be very easy to analyze for us I mean as easy as any clinical trial and tell we'll have that data. The second stratum, what we would do as we screen people first for presumptive see three g., we would take their levels how circulating soluble Mac.
Influxes then they would go to biopsy, we always tough biopsy to the end unless they were already biopsy proven.
And what's happening is that people with low circulating soluble Mac just converted a much much lower right what that tells US and this is the beauty of clinical medicine in a pioneering area.
It tells us the original hypothesis is in the main correct. If you have biopsy proven C G you're likely to exhibit.
Evidence and your blood stream of activated complement cascade for the alternative pathway and it's the rare exception, but they they're not non existent, but.
It's much less common to have low circulating complement so.
We're going to provide the data for what we have and frankly, even as we sit here today, we have the largest dataset in the world on C. Three g. from a randomized controlled trial, it's all still blinded to me. So I don't know what the result is.
But the there's a lot of people in the community of expert saying. Please just do your analysis tell us what you've got because we really think that theres going to be an answer here and we'll know once and for all whether this pathway is the way forward for clinical benefit. So that's what we'll report will continue to get as many people last weekend were obviously.
They are going to consult with the FDA before any of this is is you know the unblinded and analyze and so on we really want a database, whose integrity is protected so it can support registration even if its conditional registration, but that's what we're going to provide so I hope that provides clarity sorry about the long winded answer but are required a little.
A bit more details and then than many answers would only because this is such as such it uncharted area.
Great. Thanks for all the insides I'll hop back in the Q.
Thank you. Our next question comes from onto Palm Rama with JP Morgan You May proceed with your question.
Hey, timing see then.
That's on the continent, Hi, Tom.
Thanks for taking the question and I will just ask one anymore granularity you are willing to provide on pricing bomb last five oxychem be high beyond kind of them Youre, assuming range and more broadly why didn't hear latest pair market research the gap. Thank so much.
Thank you Tessa also excellent questions and I would love to be able to provide more granularity, but it's the one thing that we just cannot will not do at this point until we get closer to launch we are having we do have some really great and interesting.
They are research going on the.
Picture is really fascinating.
And I you know again people asked me after the advocate data, we talk about normal Norman normal orphan pricing corridor of anywhere upwards towards $200000, a year or total down to $50000 a year total the strength of the.
Good day that many observers said to me you know you're you can't be down in the lower part of that range anymore. That's for sure. If you ever were again I won't comment on that but I will say that the the robustness of the data the superiority to the standard of care the elimination of the problems that standard of care brings to the table with glucocorticoid toxicities.
The improvement in the quality of life, which does have direct pharmaco economic impact and the renal improvements, which really up.
Many nephrologist said, that's the game changer and that that value is unprecedented according to a couple of very very inform people in the nephrology community.
You know that that might suggest that our price should be robust, we're not looking for anything extraordinary though that's for sure.
But the economics are supported I mean, I'm staggered by some of the data that we get even early on for example, you know if you look at incidence and prevalence adjusting the U.S. people will debate whether that total number is some between.
55000 to 85000, it doesn't matter, let's just take you know you can take any number in that range. There's still 15000 hospitalization each year in the U.S., where he could vasculitis is involved.
And these are lengthy hospitalizations on the average of.
In 11 days, a you know upwards of a third of these people develop.
Infection in the course of this hospitalization for having infection as part of the hospitalization. We can guess and we have some data to support that much of that comes from standard care and of course, those hospitalizations or.
Super expensive, there's almost a 5% well, let's just say to be fair somewhere approaching four 4% to 5% mortality of these these very closely watch people.
So tons of hospitalizations lots of hospitalization days lots of infections lots of mortality.
With the and that's just a fraction of the picture in the United States. So.
I'm not worried about pricing too much because I think we will absolutely be able to show the value and we'll certainly have lots more to say about that end. The pair research as we get to you know certainly go through the year, but certainly closer to.
I'm sure, we'll make it very clear what we're thinking.
Hey, thanks, so much time.
Thank you.
Thank you. Our next question comes from Ed White with H.C. Wainwright you May proceed with your question.
Hi, Tom Hi, Susan Thanks for taking my question. So maybe the first question I have this.
On a rough.
Your I've heard of their 95% and role now.
What should we be thinking of for.
Looking at the when the topline data comes out will there be any.
The crossover data for the additional 24 weeks or will there.
Just be the.
12 week data and then what are you looking for what would you think would be a you know a positive result, there and then just on the secondary endpoint of quality of life time again, just wanted to do you get your thoughts on what you view was a positive quality of life so that trial.
[noise].
Great question, Oh, I'll have a little more granularity around the first point well. We're we're really focused on the 12 week data from the the blinded period for the Q3 readout had.
And so that's what we're committing to that's what we'll see and we were.
Where.
We've been talking about the 12, we get is from the start only because that is the registration endpoint.
Hi score what are we looking for with high score I mean this is a this is an index that's driven largely by investigator assessment.
Some would say, it's a very subjective index or certainly amount.
Subjectivity ending in it and so one has to rigorously control the high score.
Which we will be obviously presenting as the primary endpoint data at 12 weeks and if one does that if one trains the investigators to a high degree certifies both investigators.
In sub investigators on high score assessment. If one then secondly, standardize is the way those assessments are done both within a site and between visits and between all sites up and that is absolutely. The second the central endpoint is getting a good clean high score.
And then third one must monitor during.
A blinded phase that those assessments are coming in and making sense.
And if not they have to be called out in the investigators comp contacted and then that's actually a lot of work, but it is not an intractable amount of work. If one does that one ought to be able to see a.
Ration that indicates clinical benefit or at least clinical meaningfulness, a in the high score and that's what we're aiming to do there's one drug approved as you know humira that used to high score endpoint at 12 weeks. They showed they had two trials. They that was before they had an orphan drug designation.
But.
In any case, one trial showed on the average of 20, 25% a difference between the active arm humira and the background medication arm.
And those part of your trust so.
[noise], if one shows a difference of 20% or more I think that will be.
Very interesting effect so the way to do that is to make sure high score is giving you the best readout possible that placebo responses controlled we've done a lot of work on controlling placebo response, as well and as I said training training training standardized standardize standardized monitor monitor monitor and you'll get a.
Okay. That's that's interpretable, that's what we'll be focused on for 12 weeks in Q3 of this year, we'll have other secondary endpoints, including something called the I. It just for to look at there is a quality of life index. That's adapted for the hydro notice you for Chiba patient population.
That does focus and more on the things that matter to them I hesitate to say, what I think successful looked like there Ed because it just hasn't been well validated yet in these trials. So I think we're just going to have to see where the data take test, we're continuing to talk to experts who.
Develop this index about really what are the most important features and we'll certainly be talking about the elements that we have information on Q3.
But that's what we're committed to do for Q3 2020.
Okay, great. Thanks, Tom.
And then if you can just tell us.
Where are you are as far as preparing for U.S. commercialization you did mention the field force of 50 to 75.
Yeah people I'm, just wondering where you are as far as hiring them. The medical liaisons medical science liaisons et cetera, and then also if you can compare how you think the.
Launch in the U.S. will compare to the launch in Europe, and how more difficult it could be to launch in Europe. Thanks.
Oh, good questions were making really wonderful progress I'm very pleased with how much of the come or commercial infrastructure. We've laid down so far we did that a lot and before data.
So we really totally accelerated since the data as you can well imagine so our med affairs team is shaping up beautifully we've got a great new medical executive there our head of commercial has done a great job and bringing in or market access people and other key positions.
Every day, we seem to have five or six new people around the infrastructure [laughter] tiny exaggeration, but but not much naturally were were the field forces. The most well it's the piece of the puzzle that you're kind of slot in the last before your your your your launch but even.
There were making great progress because the the hirers of that talent are being actively recruited are already in place. So I feel great about the commercial launch and and the structure, we have in place so far and where we're going with that.
You know launching in the U.S., we've really got to beat on that I I think.
Thank you saw the little graphic in the slide deck, we know personally as an organization and you know me personally as an individual so many of these top prescribers and they're not that many I think the chart showed a 30% of the prescriptions are driven by you know a couple of hundred sense.
The docs and said you know a few centers those people almost all personally known to our company and the of course, the nodes go out from that and that work to get to about 80% of the prescribing physician population.
Matala just in Nephrologists the major focus so again I think we're in great shape.
We have a wonderful core presence in the community in both rheumatology and nephrology to be able to reach out I think very quickly to the majority of the Anca vasculitis patient prescribers.
And of course, we have one system, if you will in the U.S. Oh to.
But I understand that although state by state there are some different licensing requirements as you couldn't well imagine, but it is a much more straightforward operation than Europe, where of course each jurisdiction. While they have you know a European medicines agency the local health authorities in each country are the ones that negotiate separately for how's the.
Doug is marketed and priced and they all have their own standards I must say, our our partners that Vifor pharma.
Have a deep and long experience in Europe, and I've been Super impressed.
How they've been planning to European launch and all you know getting out ahead of.
The questions with the local.
Health authorities and having these discussions and so far as possible.
With each of the country specific payer organizations. So it is gonna be more daunting, but they've had they'd been added for awhile and they've realized both from their experience with other products as well as.
The evolving landscape with Europe, a that they had to start a in earnest stuff a lot of their discussions and analyses a lot sooner and I'm pleased to say they they seems to be seem to have been doing that really well I'll defer any specific questions of them of course.
But I've got great confidence that they're going to have great launches and and throughout.
Europe as well.
Okay, Great time, thanks for taking my question.
Thank you Ed.
Thank you and I'm not showing any further questions. At this time I would now like to turn the call back over to Tom Shaw for any further remarks.
Well I wish just to thank everyone again for.
There are times with expenses with us on this afternoons call I know that we're all faced with a number of challenges both short term tactical challenges and longer term challenges I'm convinced that together as a community will need all the challenges are confronting us certainly in the public health situations that are in front of US right now and ultimately be able to get back to the core business as long term.
Term.
Growth and value creation for all of our patience and shareholders I very much again. Thank you for your great questions. Your attention and I look forward to speaking to again in a few short weeks. Thank you very much by now.
Thank you ladies and gentlemen. This concludes today's conference call. Thank you for participating you may now disconnect.
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