Q3 2020 Viela Bio Inc Earnings Call

Good afternoon, ladies and gentlemen, and welcome to the Viola Bio <unk> third quarter 2020 earnings conference call. At this time, all participants are in listen only.

Mode. Later, we will conduct a question and 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 at Villa Bio. Please go ahead.

Thanks, and welcome everyone to our third quarter 2020 earnings call. The first release reporting our financial results is available on the Investor and you get paid for corporate website at <unk>.

Couple W. dot feel a bio dot com.

Joining me on this call today are CEO, Chairman and Chief Executive Officer, Werent, <unk>, our Chief Medical Officer, and head of R&D and Bill regular senior Vice President head of commercial.

As a reminder, we will be making forward looking statements regarding financial outlook. In addition to regulatory product development and commercial logic implants and Richard activity.

These statements are subject to risk and uncertainties that may cause actual results to materially differ from those forecasted.

Description of these risks can be found in our most recent form 10-Q on file with the FCC.

Like many of our peers in the Biopharma sector. We continue to closely monitor situation around the coal Goodnites youth endemic including de associated or restrictions on travel and work that had been implemented.

As well as to potential impact in our business in clinical trials.

Well, the extent to which Couponites you may impact us will ultimately depend on if you strip element, which of course are highly uncertain and cannot be predicted.

This includes new information, which may emerge concerning the severity of the krona borrowers.

Actions to contain over 19 potential treatments among competitors.

That I like to turn the call over to <unk>, Chairman and CEO.

Second Mitch good afternoon, everyone. Thank you for joining us today.

Without ever weren't remained stable in a well during these challenging times.

Our where we already own and then.

Taking the necessary steps to protect and enable how we can go east to work safely you from home.

While we continue to adapt this ever changing environment I could not be more proud of our teams, we didnt productivities and collaboration in this period.

Well continue to execute commercially and operationally and how we started the progress on the clinical development front.

Oh, well remain committed to our cannot commission so be patient.

This quarter, our core focus has been on the up at least not also known as I left the middle map commercial launch.

Which is progressing well and largely in line with expectations.

While you don't read age we are seeing a diversified patient prescriber and appealed mix.

Indicating that our field teams have successfully engaging without reach all talking to groups.

Toward the end of Q3, we began building strong momentum.

I'm pleased to say has continued to steadily into October.

The COVID-19 environment has presented maybe trying to just what.

What a deal and I guess how are your commercial team. Oh stayed ahead of these with a well defined strategy for reaching a broad range of community physicians and academic centers.

I believe this white label I will continue the success and the grew up in the snow in the months ahead.

Feel we'll be providing further details on our progress in just a moment and we look forward to take your questions at the end of todays call.

Given the current treatment landscape and being ammo STD incidence, we believe that the patients outside of the U.S. encoding many Asian countries could potentially benefit from treatment with either the news on that.

Yes October our BLE.

Accepted by National medical products out and distribution.

P.I. in China how.

Our original partner Hi to pharma will be responsible for marketing efforts if approved.

Likewise, our partner Mitsubishi lobby formal corporation has filed more p. authorization applications for our localism Abbott in Japan, and South Korea.

That's we and our partners or wait for the potential approval.

Nothing is a map there's several Asian countries, we continue to expand its at the bottom end use at U.S. impairments disease, including my senior grab these parents hi, GG four when they did use.

Well, we believe it could have a significant clinical benefits over existing therapies.

Recently initiated the pivotal trials in both of these indications.

While we pursue with the potentially expansion I know because about two additional patient populations, we continue to make solid progress across our entire pipeline.

Turning to we I'd 70 734.

Yesterday, you weren't HCR convergence 2020.

Reported the full walk into final data football season, one B trial, you can switch.

What's cooking is Nicholas Yulico, My Twosies, well see how are you.

These data demonstrated the potential to reduce the lesions in lupus patients and be a problem at all what decision to push it seems kind of like this you see similar cases.

Oh definitely well I'll grant phase two trial.

As you will recall last.

Last quarter, we announced a new trial with the IB somebody said it was pretty cool in patients with COPD mightier related ocular injury, we have since initiating that study as a patient a woman is progressing.

Additionally, we continue to get more new patients into all ongoing trials with the I 49, 20, which would include speech two studies Im sure when single input. That's why do you had a kidney transplant rejection.

Yeah, we all can get to stop making one right Andy why you preclinical candidate by the end of the year.

So as I held briefly outline the young will cover in more detail dealings I call. We help the old Saudi the momentum on the clinical problems that went to Dodge well into the next several years, we look forward to providing top line data from some of these filed a feature back to meetings.

With that I'd like to hand, the call over to feel weak its senior Vice president head of commercial to provide overview of our product launch deal.

Thanks, Brian.

We are pleased with our progress to date.

As you might imagine these are challenging times to launch a new drug, particularly in a patient population that is immune compromised.

Despite the external situation, which has resulted in patient visits being down and many other offices operating remotely and reduced capacities. Our launch is progressing largely in line with our expectations.

This is a credit to our entire team who did an incredible job leading up to the approval of the listener in driving awareness and preparing a flexible outreach strategy, they accommodate spokes face to face and remote interactions with their customers.

Several months into our launch we continue to Clark important insights and tweak our approach to best meet the needs of our customers.

We'll be sharing more about any earnings in just a moment as well as the ways in which we have adapted how we engage with individual practitioners and centers of excellence across the U.S.

We are aware of it staying flexible in this environment will be critical to our future success.

As you can see on this slide the first prescriptions for listening were filled in July [noise] Walt.

While the ramp was somewhat gradual at the start as we had anticipated we began to gain momentum towards the end of the third quarter, which continued through October.

We are encouraged by the product update today and are confident that our go to market strategy will enable continued success.

[noise] recent approvals of multiple new treatments for animal Westie has resulted in more options for patients and a dynamic market. However.

However, the unique product profile that listener has several important characteristics that differentiate it from other therapies.

And supports positioning it as a first line treatment option for uncle porn for positive adult animal Westy patients.

These include first and foremost.

A strong efficacy profile based on the end momentum trial in which 89% of patients with up listener as monotherapy, where a tax free at the end of the randomized control period.

Equally important optimism that has a favorable safety profile with no black box warning.

Oh. Please know also has a more convenient dosing schedule requiring only a single 90 minute infusion every six months after initial doses and finally up listener is the first and only b cell depleter approved for animal rescue.

No other animal whats the treatment option can offer this a full set of benefits.

On slide seven we will go into more detail around the impact of cobot, Nike and how we have adapted our strategy around three core elements critical to launch access.

Leading up for approval, we establish solid relationships with animal whats the treaters throughout the country. In addition to the major patient advocacy organizations and have continued to build on these relationships after launch.

This has allowed us to have meaningful discussions about Panama westie end up listener, despite the challenging external environment.

We have also increased our emphasis on non personal promotion to ensure that we can continue to educator customers, even when we cannot interact with them directly.

Also with patient visits decreasing and many of them being conducted be a tele medicine, we are continuing to work with advocacy organizations and increasing our outreach to patients via social media to ensure that they are getting information they need to appropriately manage their animal westie and understand the potential benefits of up list.

No.

We believe this approach will be an effective means to reach core patient population, which include those newly diagnosed with anyone what Steve and those who are experiencing inadequate response to their current maintenance regimen.

We have also improved our outreach efforts to H.C. piece using advanced data techniques to help ensure we can deliver timely education.

Animal whiskey is a rare disease with only around 10000 active patients in the U.S.

For most physicians outside the major academic institutions, they see animal westy patients very infrequently and may not be entirely comfortable treating them all.

Our aim is to provide timely and ongoing support to these physicians so that they can help their patients achieve the best possible outcomes.

Finally, as access is critical to every launch we need to ensure our hub, it's as user friendly as possible. It's easy to use for people who are working remotely.

Overall, our hub services, which include support program for patients caregivers and health care professionals offering educational resources financial assistance and insurance information to help them with one on one support have been very well accepted.

We have continued to refine certain features.

Including streamlining the information required on the patient referral films.

Enabling secure direct mail correspondents with our customers to allow for interactions to occur more easily outside of regular business hours and development of electronic portal to further improve the usability of the hub.

Our ability to remain flexible and adapt quickly to the changing external situation has been critical to our success. So far and will remain so given how cold it is impacting different parts of the country and the uncertainty around potential future waves.

Moving to slide eight prior to FTC approval, we conducted market research with over 75 academic and community based neurologists, who treat animal study to better understand their perceptions and behavior is when managing this disease with some of these key findings presented here.

We learned that close to three quarters of physicians expressed a desire to reduce or discontinue off label treatments based on the availability of approved drugs.

Moreover, about 70% of position say they would prefer an approved treatment with proven efficacy as a first line therapy over off label treatment.

Lastly, about half said they would consider changing their patients therapy, even in the absence of an attack.

These perceptions laid out some significant opportunities for up listening at launch.

Early into our launch we have seen most of these perceptions play out.

Based on the HCP reported breakdown or prior therapies for patients being prescribed up listener not counting patients converting to commercial drug from a clinical study.

About half the patients have prior experience with Rituximab, which is currently the most commonly used therapy for animal westie.

We also see a group of new treatment patients along with those coming to up list not from other therapy options in regard to the on known group. It's important to note that this data was based on information provided by the physicians.

When we look at the prescriber profile, we are encouraged by a near even mix of community and academic positions. Our team has worked very hard to reach a diverse group of academic and community doctors and have successfully establish relationships with our target customers from each of these groups, which we will continue to build on.

In the coming months.

Regarding reimbursement and patient access we're very pleased with our progress which is in line with our pre launch expectations.

Our payer team has met with most of the top payers to share information about animal westie end up listening.

It is still very early in the launch our pair mix is largely as anticipated with approximately half the patients having commercial insurance and most of the rest being insured by government programs.

So far the uninsured population is small and we will continue to track this given the external environment.

For our market access perspective, our distribution processes have been established and are operating very smoothly with the majority of shipments going through specialty distribution.

We're also pleased to see that the vast majority of populism that patients are using our hub services, which we continue to refine to better meet the needs of our customers find.

Finally, though it is still early and policies have not been put in place for most plans there have not been any delays in approvals and the prior authorizations that we have seen have been consistent to the label or and momentum criteria.

Looking through the year ahead, we expect to retain broad positive payer access grew up listening under medical coverage with open access aligned to our label.

We have been able to share with all of our top targeted customers.

Our animal once the burden of illness presentation, and or or clinical presentation for up listener.

Already we have over 80% of commercial lives covered and we expect this to grow and support our position about listener as a first line treatment option.

Our aim is to prevent future animal west the attacks, which may lead to permanent disability, and we believe that up listen, though will provide significant value to the patient community in this regard.

We remain committed to patient access and we'll continue to work with payers to establish coverage for patients given the strong value proposition optimism that provides.

At this time I would like to hand, the call over to Dr., you weren't drop off our chief Medical officer to provide an overview of the current and future development plans of this program as well as an overview of the rest of our pipeline.

Thank you Bill.

On Slide 11, you can see that we have made substantial progress in advancing our clinical pipeline.

Since the last earning call we have initiated pivotal trials in the realism, and let's see the gravest and I just you full related disease.

We have also resumed phase two trials have you had before you got 20, and Sjogrens rheumatoid arthritis and transplant rejection.

We're continuing to enroll the cold 19 acute lung injury trial of VIP seven seconds before and we have obtained final results for our phase one B study.

For the three four in cutaneous lupus and I will show you some of that data in the coming slides.

Hi, Little summary of this trial is not presented in slide 12.

This trial has achieved what we set out to demonstrate the I'd be seven cents before potently depletes, it's that's difficult to predict so not only in the peripheral blood, but also tissue residents ptcs in flames of skin.

Some of these results we are planning a phase two trial in a fairly that's really initiate in the first half of 2021.

On slide 13.

You can see but I'd be seven cents before quickly depleted ptcs or the peripheral blood in a dose dependent fashion.

This is consistent with results from the phase one study.

Well the Rightside panel you can see the Ptcs was successfully completed not only in the blood, but also the skin of patients back to future use.

Each patient cohorts, two and three of the study at a skin biopsy before and after three months of treatment would be I'd be 77 to before.

You can see that the number of Ptcs is dramatically reduced following treatment would be I'd be seven seconds before.

Okay.

14, you can see that this was also reflected a clinically significant improvements in the cloud the activity score, which is a measure of the extent and severity of the skin rashes.

The decrease of four points or more is considered clinically important.

On the top right Peddled, you see that a very high proportion of patients treated with the highest dose of VIP seven something before achieved this outcome.

Looking at higher hurdle in once you see that there was also a high proportion of patients who achieved improvement of 50% or greater or even up seven points or greater.

These clinical improvement for also reflected in changes in Biomarkers, such as type wasn't a fear unregulated protein expression and skin.

On slide 15 based on these results we have made the decision to continue development of yet to be 77th before in systemic lupus.

There is compelling evidence that this regulated type one interferon signaling is a critical part of the Pep agenda since it's silly and Bdcs are dominant producer of tech one interferons as well as a whole host of other cytokines and chemokines.

There remain significant unmet medical need and definitely with only one biologic treatments approved whose efficacy has substantial room for improvement.

We are looking forward to start the phase two trial in office to make it was in the first half of next year.

And you feel like you've seen we started out developing it doubled ism bump animal spectrum disorder, a rare disease, but we are now well underway towards moving into larger indications with high unmet medical need and also significant commercial opportunity.

With that I would like to turn it over to Mitch Chen our Chief Financial Officer.

Thanks yarn, Oh, let's keep to refer you to our press release issued earlier today for a summary of our financial results for the third quarter ended September Thirtyth 2020, and take this opportunity to briefly review a few items.

Quite a quarter or net sales totaled $2.3 million with our R&D investments totaling approximately.

Approximately $26 million.

New clinical trials, starting as highlighted by yarn.

R&D spend for the coming quarters as expected to incrementally increase.

For extra money, we invested $14 million into third quarter as we address some U.S. commercial sales team efforts into a virtual setting out to potentially endemic continues to impact the U.S. and.

Our total operating expenses for the quarter.

It was about $40 million.

Together with our other income our net loss for the quarter ended September Thirtyth 2020 was approximately.

$40 million the translate into a GAAP net loss of 69 cents per share for Q3 2020.

At the end of third quarter, we had approximately $388 million in cash cash equivalents and investments, we expect our cash runway to extend into 2023.

The ongoing global endemic remains a challenge for many around the world as.

As we continue to adapt to adjust to the potential impact of the globe endemic yellow remains in a strong and flexible position to grow up lift in the U.S. and advance our R&D pipeline.

I'd like to hand, it back over to Ben.

Thanks, Mitch. Thank you again to everyone for joining our call today as you heard all commercial launch is off to a solid start.

Oh lunch success I'll call focus we have many priorities on technical problems.

We continue to get rolling patients into phase three studies I know because I'm out in addition to our trials. We I'd 49, 20, it should create syndrome, Ari and kidney transplant rejection.

For me I'd be 70, 734 were preparing to initiate I'll add a phase two trial in definitely in the first half of 2021.

As we continue to get more patients you're not phase one trial for copying lighting related acute lung injury.

On the preclinical 0.0 package to submit on I N b well be I'd be 11 16 right.

And.

We look forward to providing updates on these programs throughout the remainder of the year.

With that I'd like to open the call to questions operator.

Ladies and gentlemen, Thats star one to ask your question and if you'd like to remove yourself from the queue.

Pounds, what CMS star one.

Question comes from scheme is Fernandez with Guggenheim Your line is open.

Oh, great. Thanks for the question, so I'm trying to get a if you could maybe give us a sense of the can.

Continued pace of uptick I'm, you know, where I think we're seeing a doubling in the number of patients added per month.

You know so just just trying to get a sense if that trajectory has continued into November and if not what are the what are the sort of restrictions to seeing the increased uptake.

Along those lines as we move forward is the is the crisis or is it the increase in covered infections, having any any impacts on the uptake of the product.

Second question is just in terms of relative market share I'm sure you guys have a decent sense of the relative market share in the space you offered us up the <unk>.

The direct impact.

And split of patients that you have.

The fourth was not you know with your own sales and your own uptake, but how does that kind of compare to some of the other product launches. As you mentioned you know there are a number of other options in the space and then I just wanted to ask a quick question on.

On a 773 for just.

Just hoping to get a better sense of of perhaps when we might see that you know if there was an interim look at the things to potentially planned to to get a look at the Africa see after a certain number of patients have been treated say for you know, let's say six months.

Particularly from the S. Lee patient population. Thanks.

Thanks for the question. So this is the right set of commercial so from an uptick perspective as you mentioned, we're very pleased with the demand momentum. We started at the end of the third quarter and have really built into the fourth quarter from if you look at the mix of patients you know we have a number of them switching off of Rituximab, which we.

I think it's very strong we also do have some new patients, which is very much in line with our positioning our mix of providers a mix a solid mix between both community and academic and importantly from a payer side of things. The fact that we have a good policies in place and good coverage in place in fact today, we actually did receive our J code as well too.

We think it's also another very positive development on the payer side of things. So we are at the moment.

Second we saw in the third quarter has definitely.

Gone through in the fourth quarter, we do not provide any specific projections for the quarter for sure, but clearly the momentum we had is still going.

In regards to market share I think that that's obviously, it's a little bit difficult looking at kind of the competitors right now given that the alexia on it does not really provide too many details on that but again, we can say from our uptake has been very strong. We are very pleased with the mix of what we're getting from.

On the marketplace, a lot of Rituximab patients, which we think it bodes well for us in the future along with some first line patients again, which is very much in line with our positioning.

You want to your question on.

Yeah, I'm not sure I completely understood. The question I think you're asking about continued efficacy beyond month right.

So we saw no youre right Youre right.

If I may I'm asking about the start of the phase two study would you plan for early next year when might we see is it possible that we'll see an interim look or when might we see the first data from that study for 7734.

Yeah, that's really too early to comment at this point.

We have we're just in the process of finalizing the protocol.

We are not going to be able to make accurate predictions about enrollment rates and possible or times of interim analysis or final analysis until we have a a much benefit that's exactly when sites are being started up and what the feasibility results show.

Can you at least confirmed that there will be an interim analysis and the study or no.

I cannot.

Okay, and then a bill maybe that just to go.

ER.

Back on the on the payer side of things.

Can you help us understand the time it takes to go you know for patients to be receive a prescription and for you know basically payment to be you know fully received and covered.

Yeah, I mean, obviously, it's a very variable process right now really in launch because policies are not in place yet everything has happened on an exception basis. So we what we're seeing from our hub is very positive in fact that they can turn around the information that they are provided from the health care provider very quickly.

Often times, though the insurance companies are looking for more information to validate the.

The use of it that gets down to how quickly can the health care providers give that information back over to them. So we're seeing which starts ought to be a relatively long time with the J code and with policies putting him being put in place. We do expect that to decrease overtime, but it's still too early to variable to give a specific expectation.

And if I just ask one final question for Mitch Mitch you know in terms of.

The the dynamics <unk> non dilutive financing opportunities that the company is pursuing can you just update us on areas or potential areas non dilutive financing that that you know would be considered by the company I guess, that's sort of a question for both mentioned bank. Thanks.

Yeah, I think if you Miss so right now our cash position as I kind of mentioned earlier.

That doesn't to between 23 timeframe, which we'll get to that interview due to worse in a fortunate position in terms of cash position.

In terms of non dilutive financing if I had to guess what you implied there.

In terms of potential business development, because it could definitely speak to that as well too but the conversation right now is a is ongoing.

Yes.

Yeah in terms of Catarina artery discussions.

As you know that were looking for potential partners for optimism maybe.

You European countries. So that discussion has been ongoing as expected.

Thank you for your question.

Thank you guys.

Thank you and our next question comes from the line of Jeff along with Morgan Stanley. Your line is now open.

Thanks for taking my questions, but please note what are you hearing from your sales force and clinicians regarding the impact of the recent increases in co bid on reaching inadequate responders and potential new patients within and let's see as the and is intact different in academic versus community setting.

Yeah. It's a great question clearly you know given our time of launch in June we've been dealing with the cobot situation throughout the entire time of approval and I think actually it's actually gotten a little bit better recently, obviously, we don't know what the future is going to to to hold for any of this stuff, but I think physicians are getting more.

We're used to the fact that this is not going to be a short term situation, where they can continually just push people offer a few more months and this will all kind of gets fixed so while clearly some of the academic institutions are getting a little more difficult to see life due to restrictions we are still having good interactions with all of our customers both academic and.

Muni, either live or face to face many of the virtual excuse me many of them being virtual now so.

We will continue to track this and adapt our approach going forward, but we think right now.

Are you able to meet with and have meaningful discussions with all the customers we need to still.

Great and then for the Newbuilds Babble phase three and I give you four related disease, where youd be focusing on specific patient populations within those with high risk of flare due to more multi organ disease and are you evaluating risk of flare from baseline lab test results. Thanks.

Yeah, you're correct, we will actually focus on.

The patient population and those who are at highest risk Oh Flair Oh, the best predictor of future flares recent flair through the patient population that we are recruiting for this study is actually patients who have experienced the reason.

Our on back to free but was there was for that flare. So that is thought to be actually a better predictor of risk of flare them biomarkers such as I did before levels.

Okay. Thank you.

Thank you and our next question comes from the line of culturally with Goldman Sachs. Your line is open.

Thank you and good evening and thank you for taking our questions I want to ask maybe just in terms of your initial patient observations in terms of the patients have actually received commercial drug here can you maybe comment on whether patients are receiving that the two loading doses as as indicated on the label.

Or given that approximately half our <unk>, we're talking about experience are they just getting sort of up one initial dose and then waiting for the next dose six months down the line.

Great question, what we're hearing so far as you're right. We have a lot of patients coming over from reduction ma'am.

What we're hearing is the vast majority are still using the recommended dose as our P.I. So getting the two doses, although that's not 100% we do hear some positions, we're just giving a single dose.

Okay. Thank you that's helpful context, and then I want to ask as a follow up to some of the lupus questions I've been asked earlier with regard to up to phase two steps just as you think about the your takeaways from the CLA data that you presented at HCR.

Can you maybe talk a little bit more about any additional patient stratification or.

Qualifications or inclusion exclusion criteria that you aren't that you would consider here as you think about those who are responding best and then based on the dosing response do you feel like you have clarity on what the best.

It would be for the next study here.

Yeah with respect to your first question I think we have a data from the phase one data that suggest that those patients who had a high tech when it a fear of signature and or high serum levels of interferon interferon tended to show the best responses in terms.

Decrements of the classic score so that would suggest and then actually very consistent with.

Other clinical trials typically those will have some high disease activity, which is associated with that I wanted to feel signature tend to have the best clinical responses. So one of the critical factors for the phase two is going to be to ensure that we will enroll a population with high disease activity. So that we have.

Best position to actually demonstrate a uh huh.

A drug related effect beyond the placebo noise.

We will not exclude patients in this phase two based on due to fear on signature.

Become further down the line, but I think it's very important to actually generate I'm.

And confirmed this this data in phase two to really ensure who's the best responded well was not was reflected to respond before proceeding to exclude certain population.

Oh the.

The dose we are I'm still finalizing or the modeling at this point. So I cannot give you a final answer on the on the dose, but Joe from the data that you've seen it certainly looks like the 150 milligram dose what's.

What's the most active dose.

We have done a detailed PK PD modeling and so the dose for the phase two will be either at or slightly above.

So.

Great. Thanks yarn and my last ones are being with regard to your ex US commercialization can you maybe just provide a framework for us in terms of where penetration and diagnosis rates are for animal industry.

In those key geography is that that your partners are targeting and just kind of how you and your partners think about what the commercial ramp in penetration might look like they're industry opportunities over the next couple of years. Thank you very much for taking our questions.

Yeah, I can give you some numbers first of all we have filed in Japan already so in Japan, we estimate that about 5000 patients Oh Im always D and E. U. The estimate is about 8000 patients I think in terms of Oh and.

Under regimes et cetera that remain to be seen and that we are in discussion with potential partners were also higher filed in China.

Marketing will be handled by Uh huh.

So pharmaceutical.

But oh, China, probably has a larger patient population, but I guess it remains to be determined how much you can penetrate because that's.

The pricing issues.

Thank you well following question comes from the line of Joe.

No stone with Cowen and company your line is open.

Hi, there. Thank you for taking my questions. A couple on 7734 in the HCR update it looks like the the baseline classy scores for placebo and the.

773 board treated patients were a little different kind of 18 for for the seventh of in three four versus 12 for placebo. When we're looking at sort of the absolute reduction in cloud he score or percent reduction.

Is there something that clinician call out is clinically meaningful kind of what we should be looking for in there given that the the base I was a little bit different.

And then on a a safety perspective, it looks like there may be a little bit imbalance in infections. If you could just give us a little bit more information on and kind of the severity of the infection.

And is this related to the mechanism of PTC depletion. Thank you.

Let's start with a safety first I don't think that there's really any oh critically important.

What's the difference in infection. So there was a numerical imbalanced. These very typically mild infections I'm not a those infections that you might worry about when you think about inhibiting tough on interferon I'm signaling or bdcs. So.

The specific concern with this mechanism is theoretical concern would be viral type of in a infections reactivating in darkness viruses, such as CMV, our herpes virus sepsis infections, we did not really see that in the study that was reassuring, obviously will be to keep falling this enlarged.

Studies. So this was a very small phase one study with 31 patients. So its I'm really not possible to give a definitive answer with respect.

To 50, and I think that's a small number and then was there.

Back to the baseline some differences in baselines are unfortunately, unavoidable and tiny cohorts that include a six axis patients into two or three placebo patients, but you know if you look at the Delta there.

That's become pretty clear language so.

You look at each patients compared to their own baseline you see almost 100% of patients treated with 150 milligram dose achieved at least a four point decrement compared to their own baseline and approach.

<unk>, 60% or so depending on type one even achieved some important decrement in a way I think it's more meaningful to look at.

Individual patients and they're serving as their own control from baseline to I've been three rather than focusing on the average classic score across the cohort, which by necessity into small type of study, we'll end up at different points.

That's very helpful. Thank you very much.

Thank you and our next question comes from.

It's from the line of.

Archie go with Wedbush Securities.

Your line is open.

Hi, This is kinda shields on for Laura Chico, Thanks for taking our question.

So on a prisoner uptake electing on indicated on their third quarter update that they no disruption in there and I like the franchise. So wondering now what are you seeing in terms of the mix of patient treatment experience its core patient new cope with that.

So if you look on slide.

Slide eight in our deck, we talk about kind of what the patient profile looks like from prior therapy. Currently right now and this is positioned reported information. So there are some data we don't half year, but for patients who are being prescribed up listener about half of them have reduction happened there in their history. So we're seeing the majority of them most of the patient that we know of coming from reduction.

We do see some that are also new to therapy and then the rest are coming from other therapies, which is really a smattering of the other therapies out there approved and unapproved options from an IC perspective.

Okay. Thank you and then maybe one on 907 three for her cobot art given the fact that a couple of antibody treatments are now showing in receiving an emergency use authorization. Just wondering if you could comment on what is the barcas, except her treatment for acute lung injury indication.

I'm, sorry, I didn't I didn't catch the question what is the what.

The bar for success.

Hi, Barbara suffering I think yeah, yeah. So the the endpoint in a in our trial is a prevention of composite outcome is a composite outcome includes death. It includes intubation I see you at mission and a few other things.

So we will need to see a very clear a reduction in this outcome.

Active group compared to placebo.

It may not necessarily need to be statistically the different because it's a very small studies, that's really a proof of concept study, but there's going to have to be a a very clear different.

Okay. Thank you.

Thank you and our next question comes from the line.

Derrick or Keller with Stifel. Your line is open.

Great. Thanks for taking the question guys.

And congrats on the progress. So first question just on the utilization thus far.

Has there been any specific geographies, where are you seeing kind of the most utilization for uplift not animal safety and you know how many of these accounts have actually treated more than one patient. So that's my first question and then second question on 70 734.

Just going back to one of the prior questions. You know is the length of the phase one long enough to rule out any viral reactivation and Jordan maybe is there anything else in the data. So far that gets you positive on the long term safety profile of this asset and whether or not the study in Kobe 19 could provide any additional insight there. Thanks.

So from a kind of a perception of where we're getting the prescription from it really is a nice smattering across the U.S., we're not seeing anything really focused in one area or the other if you look at our three regions are pretty much split evenly across the U.S. and it gets down to our mix but.

Tween community and academic prescribers as well to really pleased that we're getting not only the academic centers, but also the community doctors, while the the academics, obviously have more patients. So we are seeing some multiples coming out of the academic center overall the number of prescribers. We have is pretty much split even even between community and academic.

Well regarding seven seven before safety I think it's clearly early days. So I'm. The data. We have include eight patients and others have received 150 milligrams of this drug compared to to two number of placebo patients and that they have been.

Treated over three months and Weve observed them for six month. So that's really the extent of safety data. There is I think it's not possible based on this to make any clear conclusions are predictions on the future safety. So that's that's why we do a drug development step by step up this was a phase. One then the next study will be a larger study that.

We will give US you know I think more clarity on potential risks and adverse event I think certainly the with the cobot may contribute additional data points because that is a situation where patients are actually being treated in the city of <unk> over an acute viral infection. So it's going to be very into.

Stick to see what that data will show.

Great. Thanks, guys.

Thank you and the next question comes from the line of Ron.

The Vera Bradley H.C. Wainwright your line is open.

Thanks, very much for taking my question, so with respect to the Pleasant I just wanted to get a better sense of what metrics you expect to be able to provide on an ongoing basis as we get further and further into the launch for example, you know you patient starts total patients on treatment.

For example, also a number of centers that have more than one patient on treatment. If you expect to provide any of those metrics you know in the future on an ongoing basis or not.

Secondly, also wanted to ask whether you could provide us with some granularity regarding the contribution.

Two ongoing it was not uptake specifically of switches from Red talk the map and how important do you expect that to be on a go forward basis in the coming quarters, and lastly, Ondeck was no with respect to the territories outside of the U.S. If you could specifically comment on I think you've mentioned.

Pacific lead bank.

Japan, and South Korea, the timeline between regulatory submission and regulatory approval that you expect to relax then I have a follow up on the pipeline. Thank you.

All right. So from a metrics perspective, we will continue to track and provide information on prior therapy. I think we think that that is very important.

We will also continue to look at number of prescribers and the mix of prescribers between academic and community and the other thing that will really be looking at in tracking overtime is our access issues, what we have as far as coverage and things like that those are the key metrics that we'll be looking at and I think reporting on a regular basis in regard to your question about.

Contribution ever talks about we're talking about clearly is the largest player in the marketplace right now and there's a lot of comfort with it last given the fact that we're both b cell Depleters. We do see that this is a place where we will be looking for and hokey continue to get patients from we're talking about switch over to up list now obviously, we'll be looking at the new to marketing.

Since then we've heard very good feedback from our customers around that as well too, but looking inadequate responders and looking for patients like those are on Rituximab I think it's going to be important contributors for us in the coming quarters.

Okay in terms of regulatory timeline or.

In Japan, we anticipate approval in the first half of next year.

In China is going to be also going to be next year.

He is and has been accepted.

For you.

We'll announce it when the application is accepted a Wi.

So it is going through that process right now.

Okay, and what about South Korea is there.

A potential timeline to approval in South Korea or no.

That's a potential point, we do not have that definitive timeline for South Korea, yet, but he's filed in South Korea.

Our partner me speech at the lobby will be responsible for that.

Okay and that that's a very quick pipeline question, maybe this is probably for John.

On 70, 734 can you confirm that effectively therapy, the target the target indication and certain other target indications for which.

Impact on plasma fibroid dendritic cells is reported to be the primary mechanism that effectively treatment with 70, 734 and treatment with anti BDCA two antibodies would effectively be mutually exclusive. So you would not expect to see these two classes of therapy because their mechanism of action is.

So similar be deployed couldn't comment is that correct.

I think that's a fair assumption so they both of these therapies target Ptcs and I can't I'm really.

As I think about your question can't really see any rationale why did you would.

Want to target these cells by two different antibody if they have a different mechanism of action of hours actually deplete the ptcs, whereas the other is another depleter. Nonetheless, I do not believe that they would be use conservatively.

Thank you.

Thank you.

Next question comes from the line of getting some knee huh, let's Guggenheim Your line is open.

Hey, guys. Thank you for taking my question just a couple of questions on Oh, well is now can you maybe comment on Oh, those 39 patients how many more if he or she is non <unk> what is the gating factor to get the patient what the cadence we should anticipate.

If you can also touch on if there was any inventory dynamic and what the gross to net was.

One more follow up.

So when we look at our mix of patients. We don't have any A.P.. We did have an open label extension that we are converting patients who were on clinical study drug to commercial drug although that represents a very small part of the patients that we talked about today in the first four months after launch.

From an inventory perspective, since we are a medically reimburse drugs were in the medical side not the pharmacy side. This is primarily a buy and build products. So physicians are usually buying it and and utilizing it very quickly we do not see inventory as something that is really building up anywhere in the system.

Your last question regarding a question that it's very analogous to a large molecules in the space I think for modeling purposes, most have assumed around the 20% but for US we as a company have not provided a more specific number regarding on Christina.

Right and then with regard to the to the next question I have is on the J code. So you know so far you didn't have you now got it can you maybe help us understand how will that change the dynamic what were the issues that you were facing without the J code is there anyway getting a J code click shopping.

I'm the uptick.

Yeah, Great question Hicks, it's called the J code what it really does it gives you a specific way to get your product reimburse. So until you get a J code you're using what is referred to as a miscellaneous J code, which means everything and handle on an exception basis. So everything has to be reviewed there's limited place for input and really what it does is provide.

It's probably more back and forth between the provider and the insurer than you normally would have.

Once the J code in place there is a path to do this is a specific number in basically there is a better way to get this done quicker. So there are some places that we'll wait until the A. J codes issued before they start really working with on reimbursement.

And we think that this will kind of clear path and make it much quicker from a reimbursement perspective, which may be attractive to some offices.

Okay, just one final question.

With regard to the sales that you generated can you maybe help us coordinate it how it is flowing through the PME now because it is our understanding that a new patients will get two doses in a month.

And then it comes back after six months. So how is that working out or you know how many doses does these 2.3 million corresponds to I mean, we estimate a thing it's about 22 doses, but love to get your perspective there. Thanks.

I start off here and then maybe they'll call. So chime in I think that's still kind of mentioned earlier on some <unk>. Most physicians are prescribing to label. So many are getting two doses from the beginning we're not some patients are only getting a single dose I think that represent a small minority so I would say its fair to assume that the.

The vast majority are being prescribed to label and flowing through a piano in that manner.

Yeah, I would agree with that and again would be patients coming over clinical trial, obviously they'd only be getting a single dose as well too.

Got it thank you.

Thank you and I'm not showing any further questions at this time I would.

Now ill turn the call back to management for any further remarks.

Yeah, I want to thank everyone for joining our call today have a great evening, please reach out to us.

Thank you.

Ladies and gentlemen. This concludes today's conference call. Thank you for your participation you may now disconnect everyone have a good day.

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