Q4 2019 Earnings Call
Good afternoon, ladies and gentlemen.
And welcome to be alibi fourth convert and full year 2019 earnings conference call.
At this time, all participants are in listen only mode.
Later, we will conduct a question answer session and instructions will be given at that time.
As a reminder, this conference call is being recorded.
I would now like to hand, the call over to Mr. Mitchell Chen Chief Financial Officer deal. The bio. Please go ahead.
Thanks, and welcome everyone to the fourth quarter and full year 2019 earnings calls.
Press release.
Putting our financial results. In addition to the presentations for today's webcast.
Available on the Investor and media page of our corporate website at Www Viola bio dot com.
Joining me on the call. This afternoon are being you know, our chairman and exact Chief Executive Officer, you weren't dropped, but our chief Medical officer, and build rugged Vice president head of commercial.
That's very reminder, we will be making forward looking statements regarding our financial outlook. In addition to regulatory.
Development and commercialization plans and research activities.
These statements are subject to risk and uncertainty that may cause actual results to materially differ from Ddos forecasted a description of these risks can be found in our most recent form 10-K on file with the FCC.
Similar to many companies in the bio pharma sector, we're closely monitoring the grown of ours outbreak, including the associated restrictions on travel and work had been implemented as well as this potential impact on her business and clinical trials.
The extent to wish accrued of ours impact us will depend on the future development.
Which are highly uncertain and cannot be predicted including new information, which me emerge concerning the severity of the corner bars and the actions to contain the corona bars.
Were treated impact among others.
I would now like to turn to call over to being now our CEO.
Thank you Mitch good afternoon, everyone. Thank you for joining us today.
29 team with a busy and productive year Fabiana. We recently closed initial public offerings and announced the acceptance of I'll be always for review, our U.S.M.D.A. I wouldn't be the product.
I don't be doesn't matter.
Based on strong efficacy and safety results, we believe that optimism out, which we studied as a first nine monotherapy and do all my life. These obstacles spectrum disorder or animal SD cards, a potential it to be only important new treatment option for patients who suffer from this devastating and rare and doing it for opportunities.
Beyond itll be zoom out in a brief time since our founding in 2018.
Team has made incredible progress what advancing our entire pipeline of diversified product candidates career in a series autoimmune disease.
During today's call will be reviewing all of our programs in detail, but first I would like to see a few words regarding the impact of the Carlo virus outbreak, our business and operations and how were dealing with this rapidly evolving situation.
At a present when nobody ask experiencing significant impact on delays from covet 19, our business operations and if approved.
Commercialization plans for either because of mapping gamma Wednesday.
However, you ought to prioritize piece in the house and as that of the investigators at a clinical trial sites. We have made that decision to temporarily porosity enrollment of new patients for four weeks in some of our trials.
Although it is too early to tell how impactful this pandemic will be one mindful that the circumstances continues to evolve.
We have the existing supply sub drug products available to continue how ongoing clinical trials. We also have the infrastructure in place that will allow many of our employees who work remote.
Taking the necessary precautions to minimise exposure to the virus encoding limiting our essential travel.
Like many of our peers well put in place a robust with communication plan to get sure the safety of our workforce.
Our customers and a communities and the deal with the possibly effects on clinical trials and supply chain.
Monitoring the situation carefully and not following guidance from local and federal health authorities.
Please move on to slide number four.
With that introduction I will like now to discuss Oh scientific approach and I would do vitamin strategy.
With a deep expertise autoimmunity and even on energy realize focused on understanding critical pathways that drive autoimmune conditions.
We thinking about a body she was that a targeted that's critical she had a pathway.
This approach could potentially allow us to identify patients more likely to respond to treatments. It also gives the opportunity to pursue which we indications that share the same pathway.
On the graphics on your Rightside in this slight how can nickel access modulator three pathways. The first one is auto anybody past week second one is a co stimulatory path, we go to where he's in the cytokine pathway.
Additionally, our research group continues to study and the amount of money. She was when you pathways.
Moving to slide number five this is our pipeline.
I will partner he is robust with five molecules into my 0.3 in clinical stage into your preclinical.
The because to near term milestones, it's a potential approval of I know, there's a map am I see it would it be our first U.S. an FDA approval.
Building on the success of ammo trial, what pursuing a number of lifecycle opportunities, including my senior Grammys actually just walk related disease in the kidney transplant piece insight neeson.
Our CMO yarn dropped by his here today, well discuss those you more details made on.
We're also developing we I'd be 49 twice fusion protein designed to bind to cdforty like and blocking cdforty like into the city 40 direction. It isn't the Vatican for Sherbin syndrome in kidney transplant rejection.
Our third clinical candidate is we I'd be seven severance riffle. It is currently in phase one be multiple ascending dose study, we expect the interim data for the second cohort in the first half of this year in parallel were preparing for phase two studies.
Well go onto the next lifestyle number six.
As to our attractive Adams strategy, what centered around targeting disease for which tritan options on limited.
Using a shared pathway approach within targeted cost to some indications that share that seem pathway. For example on a bit is a map has the potential to target a number of different doing inflammatory disease.
We I'd be 49, 20 has a potential to target the cost or.
That includes shipments Lukas among a number of other indications. So that is a cluster showing you that light blue.
We started with ammo indication, that's because of the high unmet medical need.
I'm always a rare disease with about 10000 patients either you as.
Now he's spending I have is a map into indications with two to five times over the patient size.
Gee energy for really disease.
Well sure brings it has a large indication with no approved therapies as a matter of fact chagrin. She is a second largest rheumatic it to disorder.
Our over 1 million suffer a scene that U.S. unknown.
Estimate for biologics addressable patient population.
Hundred thousand.
Next lights.
I'd like now to review our lead the program I Labetuzumab preschool to slide number eight.
I'd be the map is a humanized monoclonal antibody designed to target and that deplete cdnineteen expressing cells.
As shown on demographics are you are left site.
Three possible mechanisms by which this anybody works.
First of all it can potentially reduce auto anybody production and secondly, also block antigen presenting cells is antigen presenting cells.
Let me actually be sales can secrete side of times and mediators and how does a map could have the potential to block that mechanism.
As compared with Cdtwenty targeting talking to Cdnineteen can be more do you act and have more reps action that is due to the broader expression of cdnineteen MBT age of cells. It could be impressed must house and plasma class.
Because of the enhanced anybody dependent the southern toxicity, there could it be deeper depletion of TCP sales by I know piece on them.
Move on to the slide number nine.
We are developing this molecule as a potential first nine monotherapy for patients with ammo as dee.
Hey, I'm Westy is a severe and rare autoimmune disease affecting optic nerve and spinal cord.
Patients suffer from the PTC, didnt relapse or tax, which often these two blindness and a permanent paralyses.
The permitting is tremendous on the patients and their families cared care partners and on the health care system.
Did the rare disease. The estimate he is about 10000 patients U.S. 80000 to you and a 5000 in Japan.
How about 80% of the ammo SD patients have anybody to acquire pouring full.
Move on slide number 10.
Early last year, we announced positive data yet our im momentum of trial.
And momentum was our largest ever trials conducted in animal as Steve.
The trial met primary endpoint of clinically significant reduction in at risk of attack.
Risk reduction was 77% yeah, I pray for post to prison population. That's a graph on Thats left panel of this slide.
87.6% no patients were relapse free and six months.
<unk> in the intended to treat prison population with both our point for positive and then that could be some population there was 72.8% risk reduction versus placebo in six months, 86.7% what relapse free.
Slide number 11.
Yes, it does seem to meeting primary endpoints the trial met several key secondary endpoints, including reduction of wasn't me on disability reduction of M., Ari lesion and a reduction of.
As Steve related hospitalizations.
And at least a map was only Asian to show a significant impact on the disability endpoint in pivotal trials.
This is positively impact as measured by secondary endpoints could provide important benefits to patients and off what depreciation from the agents.
Slide number 12.
We continue to follow patients open label extension study large number of patients to 60 odd off to 30 into the open label extension.
That's up today still.
Around 88% of patients with me on the study meaning to them and duration is now over two years.
Importantly results from the open label. It period is consistent with the primary analyses. After one year on I know, there's a map monotherapy, 84.4% of patients with free off ammo SP attack.
So a number 13.
But if I date is coming soon the date is you eleven's twentytwenty.
It is exciting time for the company as we await potential first after the approval.
We are proud that our first approval in the disease, which treat them options on limited there is a real opportunity to make our impact onto them in the paradigm.
Slide number 14.
We are ready and a well prepared for potential commercial launch.
Our field team in place, including myself market access team and the sales team.
I'm very pleased with a talent we have recruited many of them have spent more than 15 years launching products for rare disease or when do a logical disease.
Our team is fully dedicated to ammo. This why indication Tony This gave us some unique advantage.
Bill week is I'll hit up commercial he's here with us today to answer questions you might have.
Slide number 15 with that I'm going to end the call over to you on Grappa, our chief Medical officer to discuss our pipeline you more details.
Thank you Bing.
On slide 14.
16, I'm, sorry, I would like to direct your attention.
Towards the broad applicability of the targeting the on the antibody pathway by the PTC 19, so across multiple indications.
Well there are many opportunities we have prioritized three indications.
Clinical studies.
The coming years.
The first one is my senior Travis.
And the planning phases of phase three pivotal studies in patients with generalized buys.
We'll go into a little bit more detailed in the coming slides.
We're also in the planning phases, Oh, I potentially pivotal phase to be trial in patients with I just before.
Related disease.
Both of these potentially pivotal studies are planned to initiate in mid year 2020, we have submitted the I Indeed and are in the process of filing clinical trial applications and other locales as well.
Also initiated.
Concept trial in patients away to kidney transplant highly sensitized to.
Majorly antigens.
He is to test whether in the realism of either alone or in combination with 49 20.
The one of our candidates is capable of significantly reducing titers. These.
Yes.
On slide 17, a little bit more detail about my scenic routers.
Let's see their province is a disease.
That's caused in part by all the antibodies targeting.
There is on the neuromuscular junctions.
It has many similarities to animal in that it is both diseases, our mediated by pathogenic antibody that results in tissue damage indicates that might seem that rabbits. These antibodies target either the acetylcholine receptor expressed up the neuromuscular junctions for that.
Antigen specific killer days.
Approximately 85% of cases.
Our positive for these people colden receptor antibody and approximately 8% on patients have.
Antibodies against.
Yes.
We we will study.
There's a mob in patients with generalized my senior province.
Enrolled.
250 patients.
And as I said, we plan to initiate the trial.
This year.
Slide number 18, a little bit more about 34 related disease.
Before related disease is a relatively newly defined disease entity.
Oh. These were previously known by a variety of different names.
The common feature of for these diseases is that they are characterized by invasion of plasma blast like sells into a variety of tissues, which ultimately causes inflammation and subsequent fibrosis, commonly involved organ systems include.
Biliary tract the liver.
The retrofit to NIM, but virtually any organ system can be involved.
The common feature in these diseases that they are characterized by high levels of energy for the plasma.
The level. So I just you for tend to correlate with the severity of disease.
The disease generally affects older people 60 years older.
Although epidemiological data is very scarce. We believe there are approximately 20 to 40000 of these patients in the United States.
The current mainstay of treatment is.
Steroids, these are quite effective and reducing disease activity.
However, the disease tends to recur in flare as soon as corticosteroid doses are reduce and therefore, many patients need to be chronically treated with steroids, which took and she was very substantial drug toxicity.
We will.
The ability of illiberalism that to prevent flares and disease recurrence in a phase two trial.
That as I said is.
Plan to be started in the Midland.
Trial will enroll patients with recently active disease, requiring treatment were at high risk of disease recurrence.
With that let's move onto so our other pipeline candidates.
On slide 20.
Oh, there's a graph depicting the mechanism of action for this molecule. So you have before do you my Twentys a molecule that targets the 40 ligand.
The receptor ligand apparel city 40 receptor ligand is important in three different biological pathways. One is so much duration and antibody formation that these occur in Germany centers. The interaction of Citi 40 ligands expressed an activated T cells.
And the city 40 receptor expressed on T cells is critical for Germinal Center formation. If you block this germinal center cannot form and antibody responses cannot broker.
See wouldn't ligand is also important for dendritic cell activation, absolutely activation of macrophages and the function of funds.
So if we didn't think it is a well validated target.
Early first generation antibodies targeting city 40 ligand have been evaluated in diseases, such as lupus nephritis IC Pete.
I'm going to resolve disease and initial results look promising however, these first generation molecules.
Had a significant liability that involved thromboembolic side effects.
These side effects for mediated by cross linking platelets.
<unk> Cdforty ligand expressed on platelets with FC gamma receptors on neighboring cells.
To circumvent toxicity, we engineered VIP 49 20.
As depicted on slide 21 to be not capable of engaging FC gamma receptors.
This molecule comprises two to this thing three domains that are mutated too.
Convey the.
Recognition of city ligand that it just coupled to a human serum albumin.
So this molecule is not capable of binding FC gamma receptors and with different not be predicted to be settled with the liability of places aggregation that we have very funds is very careful preclinical studies and also in the initial.
Two clinical trials, where we have seen no evidence of aggregation or any from embolic type of toxicities.
On slide 22.
The results from our phase one be multiple ascending dose study in patients with moderately active rheumatoid arthritis are depicted this is a busy slide.
However focus your attention on the lifts on site panel.
This panel depicts.
Standards outcome measure in the fruit.
Disease activity score 28 definitely it's your Pete.
As you see that there is a dose dependent rapid and profound reduction in disease activity in especially in the two higher doses thousands and thousands I haven't really.
On the right sized panel I would direct your attention to the second and third fro that shows you that some approximately three quarters of patients.
The end of the three month period, where either in the state of low disease activity for remission, that's truly the bar in rheumatoid arthritis that we have to meet today in order to.
Preventive progression of structural progression of disease.
I would also like to point out to you that we have followed patients out beyond the three months treatment period of treatment for another three months and saw the treatment effect was maintained both with respect to clinical outcome measures as well as a variety of biomarkers.
Such as Rubtwenty factor.
The city 40 cities, where did the pathway is thought to be crucial in a large number of autoimmune diseases, we have decided to prioritize.
Over the syndrome, initially as well as.
Started a smaller trial in kidney transplant rejection.
Let's talk about showing syndrome first sjogrens syndrome is the second most common rheumatic diseases after rheumatoid arthritis thought to affect well over a million patients in the United States out of whom about 100000.
Maybe.
Eligible for treatment with a biologic.
Currently no approved treatment for Sjogrens and really since no treatment that works.
So therefore, there is a large unmet medical need.
We have confidence that city 40, 60, 40 ligand is important to this disease. We know that both receptor ligand are over expressed in the circulation, but especially in inflamed tissues in patients Sjogren syndrome.
And we also know from animal models that this pathway isn't is important.
Disease.
We have initiated a trial in patients with Sjogrens syndrome.
Phase to be trial.
44 fetching falls.
On a total of approximately 275 patients and traditionally 12 children have focused on patients with high systemic disease activity.
We will also study these patients but in addition to that'd be one study patients.
Lets systemic disease activity, but have a high symptom related to dry mouth fatigue and other subjective symptoms.
This trial started enrolling early this year.
We expect enrollment to occur over the next approximately.
18 month with the Kathy.
You know these timelines may shift due to the current.
19 situation.
The second trial is a smaller proof of concept study targeting patients who have received.
They transplant and need immunosuppressive regimens in order to prevent transplant rejection.
The current mainstay of.
Good day, President rejection of the combination of 11 cents and Calciner in inhibitors.
This regimen is quite effective however comes to northern inhibitors are associated with a kidney toxicity.
Resulting a slow deterioration of kidney function, which is obviously a highly undesirable.
Patients with the reasons kidney transplant.
The objective of this trial is to test the hypothesis that the combination of for lattice and 49 20 can be as effective improvement in transplant rejection.
But associated with less renal toxicity.
Finally on slide 25, I would like to briefly talk about VIP 7734.
This isn't a monoclonal antibody that targets and antigen that it's very specifically expressed on the surface of plasma sent to a dendritic cells.
That's a subject into Dick so pdcs play a multifaceted role in inflammation. They produce a large amount of cytokines, particularly type what interferons, but also TNF IL 12, six and other cytokines.
They are also important and activating others, such as T cells neutrophils macrophages.
These cells are thought to be.
Sells into circulation antics in tissues that recognize dangerous signals, such as viral nucleic acids and complex.
And others.
Then when as they do recognize these immunological data signals.
And you to produce large amounts of decide to Kansas was active in other immune cells.
However, these cells also thought to be very important and maintaining a pro inflammatory state in tissues in patients with auto immune diseases.
For example, if you take skin biopsies of patients with lupus skin disease, you can see a tremendous enrichment of ptcs in these lesions.
Similarly, when biopsies of patients with all of your muscle diseases, such as myositis and analyze these bdcs have also been found in large numbers and they are thought to produce a lot of other kinds and maintain inflammation and these diseases and therefore, the hypothesis is that depleting T cells can into.
This pro inflammatory cycle.
We are currently the process of conducting phase one be multiple ascending dose trial in patients with lupus skin disease. The trial schematic as depicted on slide 26.
Three cohorts were enrolled the first cohort.
Were eight patients with a mix of different auto immune diseases, including.
Continuous lupus sjogrens systemic sclerosis.
Well, it's probably myositis and dermatomyositis.
Cohorts, two and three only adult patients with cutaneous Lukas.
Core to comprises.
12 patients and call. It three that was just recently.
We were just recently enrolled the last patient comprises 11 patients.
In this study is to test whether it'd be 773 for not only depletes ptcs into circulation, which we have already demonstrated in our phase one eight well, but also in inflated tissue and to that end patients, but that continues lupus will receive.
I'd be citizens before and they will get skin biopsies before and after treatment. So that we can demonstrate that these cells actually will disappear from inflamed leases.
In addition to that one of the secondary endpoints is a measure of.
Disease activity and skin lupus by the name of classic cutaneous lupus activities and severity index and so we hope to at least get a directional signal as to whether these lesions will improve overtime after treatment with.
Before.
We will conduct an interim analysis for core to that is the results of that are expected in the second quarter of this year and the final results that also include Coordthree are expected towards the end of Q.
With this I would like to turn it over to Mitchell Chen our Chief Financial Officer.
Thanks yarn I'd like to refer to a you to our press release issued earlier today for a summary of our financial results for the fourth quarter and full year ended 2019 and take this opportunity to briefly review a few items.
In 2019, we have received a total of $50 million in license revenue from our partners 30 million of which was recorded in Q4 from our partner Mr. Bisha to Nabil.
As we continue to invest in our pipeline, we invested $105 million in R&D of which about 20 million dollar was a one time milestone payment related to our Bailey filing of an evolution ma'am.
Q4, R&D investment grew to $42 million due to our pipeline progress and expansion.
For SGN, a we invested $45 million in 2019, which includes our us pre commercialization investment for I never lose about animal I steep.
In all our off total operating expenses for 2019 was $140 million, which is a 27% decline versus that of 2018.
The major contributor for the year on year decline due to the 143 million dollar.
Acquisition of in process R&D in 2018.
Together with our other income or operating loss for children. Our team was $86 million, which is 55% decline versus prior year.
This translate into a pro forma net loss per share of Dollarsseventy.
Or a GAAP net loss per share of $7.02.
For 2020, we expect our total operating expenses to increase by about a third which is primarily driven by the addition of five new clinical trials.
The expansion of our R&D pipeline.
With that I like to hand, it over back to being.
[laughter] has you'll have that just heard it is a productive and the onetime viana.
We will compress a tremendous amount between 19, we are anticipating several important near term milestones, including realize full potential product approval.
I'm incredibly proud of our team without whom this level progress would not helping possible.
With that I'd like to open the call two questions operator.
Thank you to ask a question you need.
Then the one key on your Touchtone telephone.
Again, that's star and then the one key on your Touchtone telephone if you'd like to remotely yourself press the pound key.
Our first question comes from Seamus Fernandez with Guggenheim Your line is open.
Great. Thanks for the questions and congrats on all the progress.
I appreciate the updates on the that the current a virus.
I did notice that the majority of his trials.
I have actually been at least the trials that were started last year most of them or are listed as fully recruited so in terms of the what you're doing how to manage the trials that are ongoing can you just update us on on your confidence that that those trials can continue to to operate successfully for the patients.
That have been recruited.
And that's the second question.
I I you haven't talked about the one trial that that you started the 75 patient trial in R&D.
Can you just update us on the already trial for 49 20.
That was initiated in December it also looks like it's fully recruited so just wanted to get a sense of what you're testing there and then the final question.
It's for your and your aren't as we look forward.
To the that cutaneous lupus data.
Can you just help us understand the that sort of the primary endpoints as we think about that.
Relative to the that the kinds of.
A secondary endpoints that we could realize there.
I just would.
Maybe you could just give us your thoughts on Biogens, Oh, Fivenine asked that maybe just compare and contrast, the BD BDCA to mechanism versus I LT seven thanks, so much.
Extremists I think three questions is likely to be a field by youre. So maybe the first when can we actually operate effectively given the circumstances. We can start with that question first Sean.
Yeah. Thanks.
So.
First of also the both due to Sjogrens Htwo and.
The rheumatoid arthritis, Madora trials have begun enrollment late last year and early this year respectively.
I have not been fully enrolled that actually just started enrollment so total of phone I think eight patients or.
Two trials are 10 happened enrolled we have made the decision in the interest of.
The safety of study participants as well as sites personnel as well as to respect scarce resources of many clinical trials that Institute a temporary pause recruitment in these both of these trials both of your door under Sjogrens for four weeks at which time, we'll reassess and we'll be assistance.
Hopefully I'm not just across the board but.
According to the a geographic locales.
As is typical in both of these trials. The initial so that came on first are located in the United States and some of them are in areas that are quite impacted by the growth of ours.
Pandemic and so we'll have to watch this carefully we did not feel it was appropriate.
The situation to ask patients to come for randomization ER visits.
Two medical centers, where they could be potentially put at risk and also where resources into a protective measures are capped at this.
Out of time.
We've made a couple of other accommodations for patients that are currently participating in our clinical trials, including the open label study for the interval is about as well as these so a couple of absolute patients that were in the short with already trials and these follow closely the FDA guidance, but so.
Just recently released that suggests that increased flexibility with respect to virtual visits telephone follow up enabling local labs, rather than central labs et cetera. So we're doing all of these things and we'll just have to watched the situation very carefully and see.
Additionally, both.
The second question was in regards to Jimador trial, Seamus regarding to 75 patients recruitment in Ari what the expectation about expectations I trial is youre.
So for the Madora throughout the the purpose of the trial, it's really.
To identify the optimal.
Dose and dosing.
Scheduled for late Twentys, we've seen in the phase one be trial. That's treatment effect was maintained for quite a long time.
After administration Ocaliva dosing trial, so I'll be follow patients up to six month.
The follow on trial will ask the question. So how many dose do we actually need to give and how far can be stretched the dose into so that's the primary objective. This trial. We were initially expecting to enroll this trial over approximately 12 month now obviously since we have temporarily positive role.
He to reassess.
Uptick the timelines as we go.
And the last question, it's in regard to be I'd be seven centsthree for what the expectations are when it comes to the phase when be cohort two and has that gone potentially compare and contrast to the Biogen 059 data.
Right so expectations for the for the phase one to be first so.
Did they face wouldn't be implies that is that the primary objective is safety. So that is the primary endpoint, but there are important other objectives in this trial.
Most important is to really demonstrates proof of mechanism.
Asked the question can we effect effectively deplete.
Bdcs in inflamed tissues and whats dose.
So that's.
The biomarker question and then there is a very exploratory analysis of a clinical endpoint, which is the classic cutaneous lupus area and severity index.
Definitely not designed or powered to give a definitive answer here, but we hope to at least get a directional signal that lesions start to improve after giving.
Yeah because of some report.
Okay.
Thank you for machine, thanks very much.
Thank you next one is <unk> from Morgan Stanley.
Thanks for taking the question so following up on and you're saying that you pause enrollment in some of the trials for four weeks, so which specific property pause enrollment. He said the sjogrens, an IRA and I guess what is your current thinking for studies that are about to begin along the same lots for 7003 four have all the patients in cohort to have they all been enroll.
[music].
Let's start with the last question first yes, well enrollment of the sum total before that he has now completed.
With respect to which studies have been impacted so the two currently enrolling studies, we're going to be Dora, our if study and the Sjogrens study so enrollments new randomization into these studies has been positive as I said before we finished Liam will reassess after after that.
There were two transplant trials one this de sensitization study that had extra in fact not started enrollment yet.
Well the 49 20 transplant.
Rejection prophylaxis studies that also after protocol amendment have not been enrolled and yet we have also decided to delay screening and enrollment for for those two trials as well until we have a greater degree of clarity.
On the risk benefit and the possibility of restarting trials.
And I might add that even.
If we hadn't done to step to proactively we are hearing from many study centers that they affect currently do not allow clinical research, except with very few exceptions, but believe me, we haven't proactively decided that our hand.
As well as our peers in the industry would have been forced in any event.
And then for an it goes not but can you talk about the interactions you've had with payers and what confidence do you have that patience won't need to scepter, we're talking first.
Hi, Good question Bill would you.
Yeah. Thanks, Jeff, we've obviously been having ongoing discussions with payers around how exactly they're going to position this product and I think that sees the value that on the blues map has with the primary and secondary efficacy endpoints along with the proven results from the trial in both terms of safety and efficacy the dosing interval gives us strong.
Evidence that we will not be forced to stepped through were talks ma'am I'm. Obviously this is still has to play out a price will actually make a difference there as well too, but we're not expecting that in our launch scenario.
Thank you drop right now and Oh I'm sorry go ahead.
Our next on call is gonna be partway from Goldman Sachs, calling on.
Hi, Thanks mentioned that good afternoon, everyone. Congrats on all the progress on my first question is is a commercial want rather than our bill can you just comment on Salesforce hiring you know where you are ultimately thinking about with regards to sizable salesforce and with regard to targeting I understand the chart.
Lets her and that's treating centers and what does that imply in terms of patient coverage.
As you launch in Netherlands, Nab here in 2020, and then I had two clinical questions and follow ups.
Okay.
Alright sounds good Paul Thanks for the question in regards to Salesforce or sales forces are all fully staffed already done includes or MSL team or market access team and our sales team we've been able to get hire a very experienced team. They average over 15 years of experience in have.
Exposure to both rare diseases and neurological diseases. Overall, so we think it will be people were in very good position from a sales force perspective as far as coverage goes when we looking after the territories in how we set this up we looked at the overall universe of who is currently prescribing animosity drugs.
Particularly the I asked teased immunosuppressant drugs and built the salesforce around that so we will be covering both the academic centers, which will be more of the primary focus but also the community doctors who are also currently writing along with those were seeing significant patients. So our coverage should be good for all of the existing patients and we feel that it will be.
On par with our existing and potential future competitor.
Oh, Okay, yeah, yeah. Thanks for that question.
Yes, thanks for that yes, two clinical questions first on 7734, I know you laid out Youre your timelines for cohort two and cohort three over the course of this year, which contain a mix of patients.
With the systemic lupus and without but once we expect data from cohort one and how does that inform your your plans to go forward across other indications.
And the second question is.
Just on the phase three for MG have you reached an agreement with the FDA on clinical the clinical plan and if so what are what are sort of the remain if not what are the remaining gating factors. Thank you.
So to start with 70 734, so I'm just as a reminder, through the first cohort was this mixed cohort.
That was the lowest dose, which we didn't expect to be fully saturating the target.
Really be up the sole objective for the first cohort was safety unit dose escalation kotowski Oh, the second and third cohort only comprised of skin lupus patients. So all of these.
Before and after skin biopsy it will have.
The pdcs other biomarkers analyzed the objective. This is beyond safety. It's also a biomarkers as well as a directional signal on clinical efficacy.
And then with respect to you might see the gravel, yes, we have filed the I. Indeed, we received minor comments back from the agency.
There's general agreement on study design endpoints and other key.
Elements of the study designs.
Do not expect.
Many areas.
Great. Thanks.
Next we had this Chris Shibutani from Cowen Cristiane.
Great. Thank you Michel.
I think you've sharing with US. This open label extension data for the first time going out beyond the time period that was required for regulators maybe could you just highlight in particular any observations that you saw either in terms of the efficacy profile or the safety dimensions between the two groups, particularly who received the extended dosage.
And then secondly, just to clarify whether any differences in the discontinuation rates between the drug study population versus the original placebo control group.
Could I just clarify that are you referring to the enabling them up open label extension trial.
Yes, correct, that's right, yes, I think that slide today I'm not wrong introduces curious now up to 365 days extended versus previous data disclosures.
Making sure that we understand any key takeaways that you have in terms of what that data is.
So I think key takeaways are but the safety profile remains unchanged. So we have not really seen any new safety signals that would raise any concern.
A second key takeaways, we have seen a very low number of additional attacks. So as you saw from the published randomized controlled period, even in the treated group there were a few it's a tough they occurred by and large early on after initiation of treatment, we see them up.
Beyond the randomized controlled period as patients are on ineligible for a longer time that we.
See virtually no new attacks occurring so it seems like over the patients by and large stabilize with extended treatment.
Uh huh.
Safety Wise again, [noise] no new signals, we have a little bit more data now on the trajectory of immunoglobulin Titus that's an expected class effect that associated with basically all a b cell depleting therapies and we.
Before we see a slow decline in IBG levels.
There's really only been one patient that actually has reached a level of edgy that could be classified as I look I'm, a little bit anemia, and all others. There's a slow decline will follow this obviously very closely but it's.
Not dissimilar from what it seemed with other building feeding therapies.
Great and then some very quick housekeeping questions really relevant to cope with 19 impact should we assume because we're not saying anything that you do not anticipate any issues for in terms of manufacturing for supplies. The drugs for your commercial launch and number two you would not anticipate that there would be any risk to timelines relative to the FDA.
Review with your June 11th could do for reiterated our both of those quite intact and protected from any koby 19 related issue.
Yes in terms of if your timeline that we do not receive any formation took into your two indicated there will be a delay. So we continue to prepare for our commercial launch.
It's too for the product we have we think we have adequate to supply already here. We also put him in pace mitigation plans to make sure that our supply chain is working and were working with.
Most on the things.
Great and finally, just take a stab European partnership any update there. Thank you.
Yeah, you know as you as we communicated earlier for US we want to launch I live is I'm happy to U.S. ourselves.
In Asia is prepared for that will actually you actually the probably wait till we have for you European countries will continue to discuss with potential partners. So that is currently don't really.
Great. Thanks.
Next we have gotten from Guggenheim.
Not in Europe.
Hey, guys. Thank you for taking my question just a couple of question on enabling them out and have first following up on the last question that crashed gosh can you maybe remind us where you are with the pre approval in manufacturing its inspections, but did not do in enabling them up is that done.
If you can come in there and then also comment on your expectations for the label or how should we think about the black box. If if if any and then I do have a follow up.
Okay. So first question being with guilt and the second one will be aren't yet in terms of product manufacturing, probably a yet you might recall that our products manufactured by as silica.
We haven't seen said that they have it seems clearly inspection by the yes have yet.
With respect to the second question so be it.
It's a premature to talk about the label as we have not to have received a red line.
They will get from from the agency or we have and will continue to advocate for label that based on Oh. The results of the clinical study right. So I met its primary endpoint.
But several key secondary endpoints and that is what we expect to see reflected in the label I do not see any reason why we should expect a black box warning.
I know you have a question on silver Bill.
Thank you.
Yes, I have a follow up I mean, I'm just can you maybe talk a little bit about the size and scope of the G. And you try to another thing you on did mention that for the M. do you are thinking of recruiting about 250 patients will that just being a CHF positive or you were you thinking about the Dimmock square the negative pension and how the pouting route.
Will it be just on a CHF positive or not and then with regard to the I.D. for I didn't I didn't catch if he said how many patients are you planning to enroll could you. Maybe also comment on how you are defining that that disease, because some of the competitor out there have put out a number which is probably a lot larger than.
That's what you are estimating so just help us understand how you're defining edgy patient population.
So let's start with my my senior Travis.
So we will study both stage are also <unk> as well.
Population total numbers about a 250 as I said.
With respect to the majority for related disease were using the newly.
Implemented.
Our and Hewler diagnostic criteria to find this patient population.
Does that answer your question.
Yes.
Thank you.
We have grown from C. Wainwright.
Huh.
Thanks, So much for taking my questions I think the first one I would like to ask is probably for Bill I was just wondering if you guys had kind of thought through any specific modifications to sales and marketing strategy or ways to overcome the possibility that perhaps your salesforce might not be able to engage in.
Face to face promotional activities, depending on how long the corona buyers pandemic related crisis, where the last of the United States.
Yeah. Great question. Thank you for clearly the overall objective over launch isn't going to change at all the.
Believe we have a strong argument to be a first line therapy in animal West you used to know.
A lot of patients and that's not going to change and right now it's really too early to understand the impact here knowing that it is very different across the regions. We are looking at this we will be tracking you Miss overtime and making sure. We do have contingency plans, so our how might change a little bit, but what we need to accomplish will remain the same.
Okay Fantastic and then just a couple of classic adored points regarding enrollment statuses and timing related issues on the clean clinical development side.
Can you confirm that all cohorts in the phase one b 7734 trials have been fully enrolled or if it's only been cohorts wanted to.
No I can confirm that all pretty concept for <unk>.
Okay, and then the kidney transplant desensitization study with I never lives a map.
Can you just remind me what you said about whether or not you are expecting to delay initiation of that study or not.
The study had not yet randomized patient screening.
Some sites were up and everything was in progress, yes, we have decided to delay.
Randomization and screening for this.
Okay and.
And then.
Just a question from from Mitch I guess.
Can you comment on what do you expect 2020, R&D spending to potentially look like relative to your previous expectation prior to the emergence of the pandemic crisis.
Just a qualitative sense would be fine, but just looking for some sense of what impact the R&D spending is likely to see from potential changes and timelines, causing a randomization relating to the pent up thank you.
Yeah, Great question, so as you aren't going to mention we voluntarily pause.
For four weeks at this moment in time and as everyone could appreciate what this pandemic that's going on it's premature to really assess the impact on 2020, because I think we're gathering and new information on a day to day by day to day basis.
At this moment in time, we will be a and weiss of us to comment Utica country GATR information I think overall as a kind of mentioned another call on the operational operating expenses, we do expected to increase by for what the vast majority contributed to our R&D, but we have not to provide additional guidance on the R&D spend due to.
The impact of the epidemic at this moment.
Okay. Thank you very much.
Yeah.
I do not see any other calls or questions on the call right now and maybe what that I will close up our earnings presentation and couponing.
Thank you.
Ladies and gentlemen. This concludes today's conference call. Thank you for participating you may now disconnect everyone have a great day.
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