Q3 2019 Earnings Call

Welcome to the Fibrogen third quarter 2018 financial results Conference call. My name is Aaron and I'll be your operator for today's call at this time, all participants Arnie listen only mode. Later, we'll conduct a question and answer session. During the question and answer session. If you'd have a question. Please press Star then one on your touched.

Please note that this conference is being recorded.

I'll now turn the call were to Michael tongue, Michael you may begin.

Thank you Aaron and good afternoon, everyone. Thank you for joining our call today, we'll be reporting financial results and corporate update for the third quarter of 2019.

Joining me today on the call or gemstone <unk> interim Chief Executive Officer, Dr. Peony, Yu, Chief Medical Officer, Ms., Chris Chunks, Senior Vice President China, Dr. earliest crew Shockey senior Vice President clinical development, and drug safety, and Pharmacovigilance and Mr. packet prenatal chief financial.

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Following that Chris John will update you on our China efforts.

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Most stated at the American.

Associated with chronic kidney disease and in Japan for CKD patients on dialysis.

Last week during the American decided nephrology kidney week 2019 fiber, Jim and our partners was felt listen Astra Zeneca presented Roxadustat data from our phase three program as well as pooled cardiovascular safety and efficacy results.

The pooled data kicked off at the high impact clinical trials session with a pack room of almost 2000 people.

I Wonder Prologis called it the largest proud for the media presentation in well over a decade.

This set of global studies covered the spectrum of chronic kidney disease anemia, and is believed to be the largest and most comprehensive study population ever reported with over 8000 patients.

Details of the data presented can be found on our website and in our press release from last Friday.

Our studies assessed cardiovascular safety in dialysis and non dialysis dependent patients use the endpoints of major adverse cardiovascular events known as mace and may plus which adds hospitalizations due to unstable angina and congestive heart failure.

The poor results show that Roxadustat cardiovascular safety was comparable to placebo in non dialysis dependent patients.

And in dialysis dependent patients Roxadustat did not increase the risk of mace and reduce the risk of mace plus compared to you poisoned alpha, but leading product currently used to treat this population.

Finally in the subgroup of dialysis patients, who recently started dialysis referred to as incident dialysis patients roxadustat reduced mace by 30% in base plus by 34% compared to poisoned alpha.

Roxadustat achieved the primary Hugo UNEV hemoglobin efficacy endpoints in all of these groups.

Of note Roxadustat was shown to raise hemoglobin levels, regardless of iron status of baseline in patients who required no supplementary IB iron and in patients with inflammation, a group that it's difficult to treat with current therapies.

Having an oil product with this safety and efficacy profile can offer patients with that anemia of chronic kidney disease and their doctors a treatment. Unlike anything currently on the market in the us or Europe .

Let me briefly mentioned a few other highlights from the quarter.

We initiated our phase three Pamrevlumab program enrolling the first patients in our idiopathic pulmonary fibrosis or IP ETF trial as well as our study study in locally advanced pancreatic cancer, our phase two IP AF trial was published in the Lancet respiratory Medicine journal and in the accompany editorial per vessel April wells of the world.

Compton hospitals stated.

In conclusion, it's difficult to imagine more encouraging phase two results of a novel drug for IPO.

In China, we booked our first roxadustat product revenue anywhere in the world and we continue to prepare for the full market launch with our 50 50 partner Astra Zeneca.

In September Fibrogen Roxadustat, one to 2019 do shoe Lake prize for innovative drug with the highest clinical value in China I.

I think you'll agree with me, it's been a very very accomplished quarter.

Now I'll turn it over to Pony, who will give you more in depth discussion of Roxadustat and the data from the us and meeting.

Thank you Jim last week, Fibrogen, and our partners pretty damn good MOSFET do for phase three we filed at the annual American Society of Nephrology meeting, which include that over 13000 kidney professionals as the nephrologist share excitement of the potential game changer anemia.

Our IP based on strong scientific foundation today, I would like to review the highlights the pool analyses, including data from six phase three trials, including over 8000 patients and encompass over 13000 patient exposure gets us studies evaluating the pace.

Populations non dialysis dependent dialysis dependent.

And incident dialysis, which is a subgroup of patients.

Recently started dialysis lift in four months of studies participation, we reported on the south of the following safety endpoints.

Major adverse cardiovascular events Mace endpoint consists of death due to all casus nonfatal myocardial infarction and nonfatal stroke.

Maybe plus consists of that Threed mace events, plus hospitalization due to heart failure or unstable angina.

All cause mortality is simply all death.

Due to any costs.

To maintain objectivity and consistency.

The events in these cardiovascular endpoints were acute dictated by independent adjudicators blind to treatment assignment.

The time to even analyses are conducted based on pulling strategy and analytical approach is agreed with the FDA and the time to Mace is the primary safety endpoint in the US supported by results of Mays plus.

Which is recognized as and.

That's an endpoint in the nephrology community.

In non dialysis.

We are roxadustat was compared to placebo, which is the gold standard in safety assessment Roxadustat was comparable to placebo in Mays amaze parts of this using a commonly applied 19 for your IP margin of 1.3.

In biology with patients rasa deals that reduced the risk may surprise by 14% compared to important Alpha and had no increase will stop may compared to the Paul using a commonly applied eni margin of 1.3.

Yes incident dialysis lots of things that had a third.

Had a 30% lower risk of mace and a 34% lower risk may surprise that you Paul.

Let's discuss the rest of the efficacy and safety results starting with non dialysis.

40, 270, plus CKD patients were enrolled into that three.

Phase three non dialysis studies compelling rocks the things that to placebo in these studies to be included CKD stage, three four and five.

Patients.

Our from 42% or CKD stage, five fair anemia tends to be more severe.

With them more event.

Chronic kidney disease and they have been generally excluded from pie and large CKD anemia studies of yeah phase.

Similarly, we include a patients with a range of islands boys.

With 40% of study patients non Ivan replete at baseline and does.

Ineligible for Isa treatments.

Based on the current decelerate, though.

Lots of things that met the primary efficacy endpoint of name change from baseline to average hemoglobin over weeks 20 to 52.

Rich.

I'm sorry in each of the Threed individual phase three studies and the pool analyses in which lots to do that was superior to placebo, regardless of CKD severity with got lists of severity of anemia, a baseline and Weve got less up I won't be patient status.

[noise] Roxadustat efficacy is accompanied by an 81% listening production in news on rescue treatment, which includes IB, Iran, Lisa and transfusion and a 74% reduction in the with the off.

Well transfusion P value 0.01.

P value less than.

Importantly.

In comparison to placebo Roxadustat patients also show a slower decline in each Jeff I was just a measure of kidney function.

Patients with base in patients with baseline Fr also team on a higher during the first year of treatment in.

The one year decline in NGL fight in rock for patients was a 2.8, which is significantly less than the decline in placebo patients of 4.4 with extreme in defense of 1.6 M. P value will has the zeros in that this represents a 30.

8% reduction in Eugene five decline relative to placebo.

Turning to cardiovascular safety.

In the CKD non dialysis pool based on I T. T analysis, wassa deals that was comparable to placebo.

For reference here the hazard ratios.

Nice hazard ratio of 1.8 with 95% competence individual 0.94, and 1.24 may surprise hazard ratio of 1.0 forward.

Competence in the bullet 0.91, and 1.18 all cause mortality House racial up 1.06 were confidence interval of 0.91 and 1.23.

We have received questions on the individual components of cardiovascular composite endpoint in non dialysis.

The most interest in stroke.

This is most likely because of the treats study on Bob proprietary that resulted in the USA label restriction in its use in non dialysis and dialysis patients.

I want to be clear from the outset, we believe the data from the individual components of maze amazed plus in the Roxadustat program are consistent with that we felt in the overall analyses stated another way, we believe the least falls into it.

Individual components are comparable.

Two placebo in non dialysis.

This is also choose for dialysis pool.

Before we delve into details I wanted to remind you that the roxadustat non dialysis program what power for assessing the Mays composite endpoint and not the individual components to give a sense a magnitude in the Roxadustat program stroke represents only 10%.

Of the mace events in the non dialysis pool and the incidence of rate and Roxadustat is comparable to placebo, which is 1.2 per 100 patients years.

In Roxadustat versus 1.1 in placebo arm hazard ratio of 1.22, with 95% confidence interval, a 0.80 and 1.86.

As a reminder.

Due to treat study the incidence rate of stroke empower people attend what price sad off.

Placebo, what hazard ratio of 1.9 to you.

And 95% confidence interval of 1.38 and 2.18.

The rest of the main plus components in our non dialysis pool is as follows.

All cause mortality a house are based on 1.06 confidence interval, a 0.91 and 1.23, which we stated earlier.

Am I.

Hazard ratio of 1.28 confidence interval, a 0.9 and 1.84 unstable angina, requiring hospitalization, what how surveys show a 0.49 and confidence interval, a 0.19 and 1.27.

Finally.

Congestive heart failure requiring hospitalization.

What you say imports, which is important in CKD patients has hazard ratio of <unk> 0.89.

The confidence interval of <unk>, 0.72, and 1.1 too.

Based on the composite endpoints are trying to make maze plus.

All cause mortality and the individual components. The overall cardiovascular safety of Roxadustat is comparable to placebo.

[noise] dialysis dependent patient pool consists of 30 880 patients who are randomized one to one to receive Roxadustat. All you Portland Alpha in Threed dialysis phase three studies the primary efficacy endpoint.

Of mean change in hemoglobin from baseline to week 28 to 52 was met in each individual study and the pool analyses.

Rocks abuse that achieve higher hemoglobin level that active comparator of Newport, an alpha. This result was seen in patients with or without inflammation as measured by CRP.

Similar roxadustat those requirements, regardless of inflammation status.

Roxadustat treated patients receiving a less ivy, Iran than people patience, while transparent saturation or T sat and measure off I one store in the body were comparable between the two treatment arms.

In addition, when compare with Paul Rudd cities that to the patients had a lower rep lifestyle transfusion risk than people to the patients hazard ratio off point ATM P value appoint all four six.

The combination of findings above reflects the benefits of coordinator every store polices with Roxadustat as treatment, we saw the in more efficient island utilization lower transfusion requirement and 10 potentially over.

Lisa Hypo responsiveness.

Turning to cardiovascular endpoint analysis offset by outlets as pool.

In may and all cause mortality Roxadustat had no increase this relative to people.

Amazed.

Wassa do that had a 14% reduction.

Yes.

Compared to equal.

I would like to point out.

Incidence rate of each of the individual made plus components.

In dialysis on numerically lower in roxadustat than equal.

Finally.

Let's talk about.

The exciting patient population.

Incident, dialysis, which is a pre specify subgroup offset by al assess dependent pool here. We studied 1500 26, new dialysis patients who commenced treatment within four months before study participation and more to that up to three years with an average.

Treatment duration of one and a half year.

In the incident dialysis pool in comparison to important alpha.

Lots of deals that treatment resulted in a 30% reduction in the real sub mace and a 34% reduction in the resumes plus what they're trying to for lower.

With that.

These materials such as potential long term safety benefits in selecting roxadustat when initiating anemia therapy in dialysis patients.

To evaluate the merits of Roxadustat. It is important to put together an overall picture taken into account efficacy and safety.

Yes.

If this drug has the potential to improve EMEA treatment in CKD patients.

Our answer is yes.

Non by Alice's our phase three program show Roxadustat treatment corrected Amelia effectively regardless of island Repletion and we do this self rescue use all blood transfusion.

While also slowing down the decline in kidney function in patients with new jafar greater than or equal to 15, while may or may plus and all cause mortality risk we're comfortable to placebo the gold standard.

Because of the safety related.

You know restriction of yesterday, coupled with the island retention requirement and the inconvenience. Our parenteral administration requirement. Currently there is little use of USA in non dialysis patients as you as are the as reported that only 15% of patients entering dialogue.

Says.

Had received prior Isa treatment.

[noise], if approved roxadustat could deliver that therapeutic benefits [noise].

With the convenience of a pill.

Yesterday, which requires frequent injection at the Doctor's office.

In addition to the favorable efficacy and safety characteristics. The convenient dosing of all meditation am removal of the financial and pond burden from physicians need to stock and inject the medicine, we believe roxadustat has the potential to.

Improved treatment access and patient compliance.

Therefore, we believe we have an unprecedented opportunity to expand anemia therapy to the millions of non dialysis patients course EMEA go on the test.

In dialysis currently that decision on the choice of ammonia agent is generally made at the early periods of dialysis treatments.

With a 30% reduction in May so, yes, and a 34% reduction amazed plus with comparable with important alpha in incident dialysis patients. We believe rocks abuse that could be viewed as a save for option for patients initiating.

Chronic dialysis, while benefiting from the robust efficacy in patients with or without inflammation with less Ivy Ireland youth.

And lower transfusion rate compared to equal in the dialysis patients.

We are privileged to have an opportunity to potentially introduce a new standard for anemia therapy for CKD patients would roxadustat.

A first in class agent base on Nobel Women's Science.

We believe these compelling efficacy results with demonstration of clinical benefits accompanied by the above safety results.

Could serve as strong basis from marketing approval.

Both the U.S.

Europe and other countries in the world.

[noise] working with our partner Astra Zeneca, we have made substantial progress in preparing M.D.A. for CKD anemia in patients on dialysis and I'm in patients not on dialysis.

We plan to submit the NDA for both indications.

Before year end, we're working closely with us fell less our European partner and and expect to file the M.A. for both indications in the first quarter of 2020.

Encouraged by the safety and efficacy results in CKD, we continue to expand treatment often media or other etiologies.

In Mds, we have two ongoing clinical studies.

A phase three U.S. global study in transfusion dependent Mds patients and they say chose to a study in non transfusion dependent mds patients in China.

Something [laughter] Gregor study, we solved all see open label leave in portions demonstrating Swanson seems that efficacy in Mds patients will be presented in an all know session of the upcoming American society of Hematology meeting in.

Orlando.

Next month.

We have also started a phase two U.S. study of Roxadustat for treating chemotherapy induced anemia, which we believe two how much opportunity to address the a met needs of a large patient population.

Our founding CEO , let.

Pioneering.

Yes, ph I saw anemia therapy.

We are committed to carry on common meth legacy to develop innovative medicines to improve patient care.

I now like to turn the call over to Chris Charles.

Thanks P. acne.

It has been an eventful quarter for us in China publication of data from the two China only phase three studies in the New England General Medicine was a landmark event, which was celebrated in China with much enthusiasm to.

The Chinese nephrology community envisions itself as leading the way internationally in the adoption of a transformative new paradigm for the treatment of anemia in CKD.

With the expansion of the China label to include not dialysis, our partnership with Astrazeneca is serving us well were able to leverage the significant commercialization capability and launch experience of what is now the largest multinational pharma in China with coverage at over 6000 hospice.

Those that represent the vast majority of the potential market for Roxadustat.

Fibrogen in China has responsibility for medical affairs, and we too have expanded our key opinion leader coverage and evidence generation activities over the last few years from the original Sthirty phase three clinical trial sites to now over 300, leading hospitals and counting.

As a joint team, we continue to advance our efforts in market development distribution reimbursement and gaining listings in hospitals.

China as the first launch market for rocket used that has given us some very encouraging early signals about prescriber and patient receptivity indicators, which are helping us calibrate the scale and scope, although ambitions for the market.

Nothing different segments of the potential patient universe.

In dialysis the installed base of over 600000 patients now the single largest single country dialysis population of the world exceeding that of the United States.

This is a substitution market for roxadustat.

Three made of anemia is well established but only one fifth of patients are treated to the target hemoglobin of 11.

There continues to be double digit growth in dialysis after accounting for deaths, nearly 100000, who patients come onto dialysis each year. They represent you candidates for Roxadustat and many have no prior Isa experience.

Within dialysis is approximately 100000 patients or 14% who were treated on Perry Tonio dialysis PB instead of hemo dialysis HD.

We believe this segment is particularly well suited for an oral therapeutic like lots to do that because patients receive PD treatment at home.

Finally, the non dialysis segment is even bigger inpatient count.

But you should use is much less established we believe as an oral therapy roxadustat has the opportunity to greatly expand the addressable market.

We expect to know by the end of 2019 atrocities that will be included in the updated national reimbursement drug list or NRG out.

Inclusion would be an important inflection point for the business as you would greatly increased patient affordability accelerate hospital listing and expand overall market adoption.

This remains a stretch goal as historically, the and our deal cycles, where farther apart in time and drugs. The other market for few years before inclusion.

India that lasted USAT is not admitted in this route reimbursement would be a top priority for us in 2020.

We look forward to keep you updated on the exciting market opportunity inside of us in China.

With that I'll turn it over to Elliott to describe this development in Penn Robinette.

Yeah.

Thank you, Chris and good afternoon.

I'd like to start with.

Introduction of Pamrevlumab.

It is if the first in class fully human monoclonal antibody.

Second hibbett activity of connective tissue growth factors, although known to us CTGF.

It's a critical mediators of the progression of fibrosis and fiber broadridge diseases.

But everybody is currently in phase three clinical development.

For the treatment of both idiopathic pulmonary fibrosis IP Jeff.

And respectable locally advanced pancreatic cancer.

Although no one's help l. APC.

Another rabbits in the phase two for the treatment of the Shen muscular dystrophy as non ambulatory patients.

These diseases share a common loyalty of fibrosis involvement.

In each of present, an area of significance and that medical needs.

And rich this patient to face dire prognosis.

I'd like to start to an update on IP Jeff.

In July we dose the first patient and does that Chris phase three clinical study.

I Love your mother and patient was IPO.

We continue to activate additional sites in this study and engage with our investigator to enroll patients.

Yeah.

We are redoubling, our efforts in improving our processes to bring sites online.

And expect an acceleration over the next few months.

Our focus now is to activate sites.

With the expectation that enrollment will accelerate in the year 2020.

In September as Jim mentioned, we announced the lancets respiratory medicine publication of positive result from the companies have price phase two clinical studies in IP up.

Showing both significant improvement in the primary efficacy endpoint of a b C change from baseline.

And deduction indices progression in quantitative lung fibrosis as measured by HRC tea.

On the known I high resolution C skin.

This paper was well received by the medical community at the 2019 European Respiratory Society International Congress.

We are very appreciative and encouraged by this reception.

And this publication the authors reported that Pamrevlumab demonstrated the potential for stabilization of disease.

And for the first time in human studies, the potential of reversal of lung fibrosis and some patience.

Like to remind everyone that to some of them up has received orphan drug and fast track designation from the F. day for the treatment of five yes.

Moving to ally PC.

Our phase two results showed encouraging clinical evidence of potential.

Of Pamrevlumab plus chemotherapy.

To transform and respectable a late this year patient.

In two patients who are eligible.

For surgical resection.

We recently announced that the first patient was divorced and lot. This our pivotal phase three.

Randomized double blind placebo controlled study evaluating pamrevlumab.

Neo adjuvant therapy for Andrus sector gold ally PC patients.

This study will enroll 260 patient approximately.

To receive chemotherapy options savvy enough paclitaxel, who will be randomized either pamrevlumab or placebo.

As you May note. This is very sick patient who is limited options.

With a primary endpoint of overall survival at the end of the treatment period.

We will be evaluating the rate of for section as a surrogate endpoint for a potential accelerated approval.

Similar to IPO of rubber will not have received both orphan drug and fast track designation from the FDA for the treatment of this disease.

Turning to Duchenne muscular dystrophy.

We will meet with that the this quarter to discuss the design of our pivotal phase three program in DMD.

We look forward to updating you in the future at this program advances.

Although we plan in the news future to publish additional data from patients who have completed one year of treatment in our phase two study.

I'm not going up has received orphan drug designation from the FDA for the treatment.

DMD.

[noise].

And clinical study in multiple indications on revenue HMA has consistently shown.

Positive efficacy results.

Has demonstrated a good safety and Tolerability profile.

We are pleased to be progressing with the phase three studies.

To fulfill the vision of our late CEO , Tom Neuf, whose goal and funding Fibrogen was to Threed cyberoptics diseases.

We look forward to updating you on the progress of the Pamrevlumab program in the future.

I will turn now to calls to our CFO , Pat cotroneo or the financial update but.

Thank you earliest as announced today total revenue for the quarter ended September 32019 was $33.2 million as compared to $29 million for the third quarter of 2018.

For the same period operating costs and expenses were $86 million and net loss was $49.4 million or 57 cents per basic and diluted share as compared to operating costs and expenses of $71.8 million and a net loss of 42 point.

$6 million or 50 cents per basic and diluted share for the third quarter last year.

Included in revenue for the quarter ended September 32019, our first commercial sales of Roxadustat drug product in China.

The related net product revenue was $600000 for the quarter.

Also included in operating costs and expenses for the quarter ended September 32019 was an aggregate noncash portion totaling $19.6 million of which $14.8 million was a result of stock based compensation expense.

As compared to an aggregate noncash portion of $16 million.

Which $14.3 million was a result of stock based compensation expense for the same period in the prior year.

As stated in Q2 2019 in accordance with US gap. We have included our revenue recognition methodology, a total of $180 million.

Comprised of $50 million for an anticipated milestones from astrazeneca relating to the filing of the U.S. and da and $130 million in anticipated milestones from a stellar us in connection with the E U M a filings.

When such milestone achievements became probable.

Included in our third quarter revenue recognition methodology is a $12.5 million milestone associated with the approval for CKD in dialysis patients in Japan.

The timing of when the payments related to these milestones will be remitted to fibrogen depends when the milestones are actually achieved.

As noted earlier on this call our envy a submission is targeted for Q4 this year and we expect the Astelit M. A submission to occur in the second half of the Astellas 2019 fiscal year, which ends at March 31 2020.

Based on our latest forecast, we estimate or 2019, ending cash to be in the range of $650 million to $660 million.

And this range includes the 50 million dollar U.S. and da milestone.

At September 32019.

Average in had $666.5 million in cash restricted time deposits cash equivalents investments and receivables.

Thank you and I would now like to turn to call back over to Jim.

As you have heard we've made significant progress over the past few months looking forward, we'll continue to drive our products programs and organization.

Here are some of our areas of focus.

First Barbarians Board and our search committee has an this year has initiated a search to find a truly exceptional leader to be fibrogen is permanent CEO .

Well update you as we have more news of our selection.

For Pamrevlumab, we're enrolling our phase three studies for both the IPO for locally advanced pancreatic cancer and we'll focus on opening additional study sites are increasing patient enrollment.

We also look forward to discussions with the up year to determine the next steps in our Duchenne muscular dystrophy program.

In China, our focus is on securing reimbursement and the upcoming Roxadustat launch we look forward to updating you on that progress in the coming months as well.

For Roxadustat, we're completing our endear submission in conjunction with Astrazeneca and plan to file by the end of this quarter followed by the European M&A submission through our partner Stellus by March of 2020.

As Pat mentioned Farber June is eligible to receive $180 million and why we milestones from our partners and we are also eligible to receive similar scope approval milestones.

Finally.

We plan to submit the data just presented at the US on for publication and we'll continue to seek out new indications for Roxadustat with our programs in Mds and superior.

At this point I'd like to open up the call for questions.

If you have a question. Please press Star then one.

I mean touchtone phone.

If you were streamed live in the queue. Please press the pound side or the hatch.

If we're using the speaker phone in managed pickup.

For passing the numbers once again, if you have a question is star then one on your cash schonfeld.

And your first question that comes from Michael Michael Your line is open.

Thanks, very much a appreciate the questions and congrats on the progress I know on their Tom would have been proud of how do you been there and congressional progress.

And one is for P. O'neil.

I would just like to understand since there seems to be some investor concern about that degree mentioned FDIC channel from statistical plans, how Youre general impression was our view on meeting with the FDA and why you feel confident about statistical protocols and they're signing off of what you have some statistics.

And why you feel good about that my second question is for Gen and Youre sheet. Although I appreciate your the interim CEO , perhaps you could talk about what your priorities are and what the board's priorities are at this point.

Given where the stock is that where things are I guess, what you're thinking about in terms of priorities from here appreciate it. Thanks.

Mike. Thank you for the good question first of all I wanted to to share at that we happening in that buyer again dialogue with the FDA in the past six years.

And.

And there has been very good understanding about.

What the phase three requires study would look like.

On site, including the the size of this study how to power Red flags and what the primary endpoint and we agree on time to me as the primary endpoint and that's how we power for the non dialysis and dialysis and we've also had a very tough.

Tell us dialogue with the FDA on the analysis of a of cardiovascular safety as well as.

Let the efficacy of requirement needs to be for this submission.

I'm sorry, the most recent conversation with the FDA.

I was at the was at the end of July .

On time.

And we had as please send that to the FDA fairly comprehensive briefing package.

And how they have a very productive meeting.

Hi, walking out of it we felt that we had all the guidance from the FDA, we needed to put together a winning submission.

And that is about to be out the door on this quarter.

So you feel no issue or no real concern about the hazard ratios in the upper bound and all the things that people are talking about you look at diabetes programs and things like that.

You are well within that so you don't feel any concern about that.

No we have no concern about that and I guess, you know bad regulatory assessments is not a based on one criterium.

But but instead it is based on totality of other than such as efficacy safety, a what is the medical need and so based on our discussions and ER and the historical precedence in this therapeutic area and the various conversations we've had.

The agency, we're very comfortable with our data whether it is now.

Okay. Thanks, Jim just for that question for you.

Yeah.

And Mike I think our I think our focus is very clear as I mentioned through the through my closing remarks are you first and foremost its filing of the India second it's finally, our through his fellow us the M&A in Europe .

Behind that is is our China and their securing reimbursement along with the support and your participation in the China launch and with Pamrevlumab, it's around accelerating both the number of sites for the enrollment in our two phase three studies and getting agree with the FDA on where we're taking the DMD program next big beyond that.

Working with the rest of the board, it's finding a very capable person to step in and lead the company longer term.

Yeah, Okay. Thank you.

And your next question comes from a Checkfree partners. Your line is open.

Thank you. Thank you very much and thanks, everybody for participating in the color just orbit or systems, which from our services simply about Tom and.

Particularly foreigner given all the recognition the progress that you've made with first analysis from a roadmap. So one question hopefully early.

From a one chris' question for Chris up Jani could you share.

The number of patients in the non dialysis cohorts for progressed ZAR Allison on the difference in timing in the progression of dialysis and perhaps comment.

About whether the patients post progression dialysis, presumably were treated with repo and behaved in the same whereas the incident dialysis patients I'm. So was there a benefit.

From for comparison between rocks are and you vote in the patients who progressed and then Chris could you talk a little bit more about the an ideal listing specifically have you applied to both trialysis and non dialysis and waters the size of the non dialysis patient population, who are anemic enough to justify treatment.

Innovative drugs such as Roxa. Thanks.

Yes.

Yes, you asked a lot of this Ah that's motors that the question was more than one [laughter].

So so and I think Todd this correct to expect battling 40% off the all of the non dialysis patient pool or indeed already had already beach end stage kidney disease, meaning hfive are being below 15 than you do expect.

Some patients to a pure required by Alice's treatment in this long term outcome program.

And so neat thing now the analysis of these patients is important because transition you know that they'll put about 10 cents a transition to dialysis.

And we have not had.

Had a chance as you see will have a we have presented a lot of data at the sand we have not had a chance to to write this one up yet and.

I agree with you. This is important that we should present and future medical conferences, our publications this a little bit complicated.

The two to report that SH culinary.

At over here.

Well with her benefit.

Oh I'm.

I'm sorry.

Was there a benefit or at least in time was there a significant difference in the time to progression to dialysis between the two cohorts.

Based on the south from the DGF our change we believe there should be but the data needs to meet the further analysis as mainly because the time on treatment between Walker things got on placebo tougher.

Okay. Thanks.

Chris I'd love to hear from your brother and our deal.

Hi, Jeff. So your first question I believe is whether Roxadustat was invited by the Chinese government to NRT out negotiations. So first Joe you're absolutely right. A sponsor is invited you don't proactively apply.

So I think consistent with what Astrazenecas partners have said the two companies are collectively putting a lot of asset in getting into NRT out.

At this point in time, we're not discussing is there's an invitation primarily because all invitations either to roxadustat like other companies I can say a confidential and the Chinese government has not published a list of companies invited.

To negotiate so I would prefer to wait until the end of year when the outcomes and RTL is disclose I hope you understand.

With regard to the second question I believe the question was what is the size potential market size of non dialysis. So I had mentioned just now in my section of the script that there are over 600000 dialysis patients in China, 90% to 95% of them are anemic.

In non dialysis if you look at the CKD population, it's actually 120 million of course, mostly they are early stage and they're not necessarily anemic. If you look at stage Threepd.

It's about 50% anemic stage for about 70% stage five non dialysis is about 90%.

At those numbers up based on the real world evidence data that we have measuring hemoglobin tenant below we believe the addressable market in China for non dialysis and limitations below hemoglobin eight is close to 2 million patients to substantially population and Jeff was.

Very excited because we have an or therapeutic with a safety profile that we think we greatly expanding addressable market.

Great. Thank you very much that Chris.

And your next question culture at a loss your line is open.

Hi, This is idling on call Adam or some for the question of of course, only before if you only for the individual is components in the AG.

Yes, the events fall myocardial infarction still you're not the data set a small on SPV will focus on the news.

Composite can you. Please further clarify on this ABT amaze dataset.

Okay.

Hi.

Yes, so out so I wanted to reiterate that are in our conversation with the FDA. The primary safety unplanned once the composite mace.

And there was never a me with a any requirements day that for us to for you know for on the individual component itself.

And saw and I also again remind ourselves side are these numbers are fairly a you know the number events a fairly small and that.

No I another thing to point out is that the lower bound the 95% contraband involved on each of these individual components are below 1.0.

Which is very different than banter stroke a into it.

And so we're looking at.

The overall picture.

And the overall safety profile of the truck looking at.

Efficacy safety as well as well as what what how little if on the market for changing the non dialysis patient.

Okay and my second question is it.

Oh when are you going to talk to very good benefits after.

Glenn I mean, the statistical analysis plan, including the non inferiority margin.

And just creep.

Mm Hmm.

Hum mix.

I am sorry about the question Uh Huh.

Are you asking when we were published these resolved we do plan to write up as soon as we can and put it in a scientific journal.

Yeah, I think Adam I figured. The question is is when we talk to the FDA about the statistics and the analytical plan.

There's the question why don't we plan to talk to them in the coming weeks Oh, Okay. I'm sorry, the answer to that question is that we had already talk with the FDA about analytical plan and we had a great made we agreement on the analysis plan I beg themselves that we have presented in the high impact Clint.

Concession ethane as sand and the numbers I had just presented were based on the agreeing a analysis plan that we have made with the FDA.

So the ammonia philosophically amounted to 1.38 already agreement or not.

So we are talking about the analysis plan, meaning how do you pool, you know, what's supporting strategy and the analysis plan how to analyze the data when you talk about Eni margins a wheel you're talking about.

The standard for assessment right and we thought as I mentioned earlier that we expect God all regulators will assess the data based on Oh on very you know all the on the Empire application.

Of the M.D.A.

And based upon our dialogue with the FDA over the past six years.

On saw and that data as we have shown.

No. We are confident that we do half what it takes Ford Oh for this drug to be favorably evaluate that.

All right, maybe another person fault, great regarding the China market.

Can you help us understand the law, so a our case there.

The whole genome.

That's what really tough the book revenue at a cost.

Brian This.

This is David Thank you.

[noise], so edwin with regard to the first question about the self pay market.

So the self pay market is not large and this is why getting intent and RTL. It's an important inflection point for the business to self pay market is.

Basically people not getting reimbursement and choosing to pay 100% out of pocket.

At a price to end and you know it's visible to the market for a roxadustat drug that is higher than the standard of care.

We have sales at this point in time. So there is a self pay market, but we do not expect it to be substantially because of that differential in pricing.

With regard to revenue recognition.

Fibrogen is the marketing authorization holder of Roxadustat in China.

Under the two invoices roll it is the manufacturing it's the marketing authorization holder get booked revenues. We have a 50 50 profit share with Astrazeneca. So that is how the 50 50 works. It's not a 50 50 split of the topline is a 50 50 split of the profits.

That's very helpful. Thank you.

Welcome.

And your next question comes from Daniel growing your line is open.

Hi, Thanks for taking my question and congratulations on the data I just had a couple of questions. This is no ROV on for Danielle by the way I was just wondering would you be able to talk a little about whether you're expecting priority review or a normal review with the NDS and.

If you'd be willing to use a priority review voucher.

Okay.

This is a very good question and.

We.

We believe Dod the basis for a priority review could be because a we have a new innovative drug Dod.

It's potentially better than what is available for treating diseases in patients was very serious condition.

However, the decision whether to brand as part of our TV view is that one of the FDIC.

So in Ravi or the second part of your question I would not see us using your priority review, Roger but we we will indeed request priority review.

Okay. Thank you that's helpful.

And I guess my second question would be out would you be able to give us just some color on the Mds study.

Hi, just how its going or how the enrollment is going and when we should expect data and along with you know with other agents that are currently in the pipeline for the indication as well how do you see roxadustat sort of fitting into from strategic standpoint.

[noise].

Oh. Good question, we do a we are seeing encouraging data from the open label potion of how phase two study, which is I believe we'll be presenting in the upcoming ash and.

I would assume the other age or so in terms of saw a kinda competitors landscape, we believe that because.

Mds is such a MBS anemia in say condition that there's so much need and so difficult to treat our believes that there are they still opportunity for us to make a difference in these patients and saw the enrollment is ongoing and we will come back.

Jack a worthing.

Hmm.

You have in the future with timeline on when the study world will be complete.

Yes.

Great. Thank you so much.

Thank you.

And your next question comes from Pouch Lee Your line is open.

[noise], hi, everyone, great to see everyone else.

And meeting and thanks for taking the question.

My first question is for Penny and.

You did state earlier that that the non dialysis population was not.

Power to individually assessed the various components amazed.

But given the the background of the patient population in terms of their EG fr level.

Can you give us what does your understanding with regard to the to the FDA position on the on the individual components with respect to when a trial is not powered to show a statistical difference on those individual points given the by patients background population.

And that I had a second our commercial caution on the NRT ill.

Okay.

So appeal or we can share our view on the individual components and I'm not that discussion with the FDA a in terms of the requirement for our primary safety endpoints.

On a as I stated earlier and there was never and any explicit expectation on the individual components.

Now, but I you know a will do believe side the evaluation to all saw what data it has to take into account the overall benefit risk off the truck for the patient.

So I.

I hope this answer the question.

Oh, yes. Thank you and then on on the NRG Al I know you said it you ever.

Do you want formerly communicate whether you whether octoplus said is under invitation to be considered but assuming you assuming it it is under consideration I.

I guess as you think about potential reference pricing pricing on the competitive landscape given the white availability of of Epo and China can you maybe give us what you think of reasonable range is potentially for for pricing on the go forward.

Given the given availability and pricing of Ebo in China market. Thank you very much.

Absolutely Paul So the way, we think about pricing in China is that follows. So first of all as value based pricing, we evaluate the scope of unmet medical need and the pharmaco economic consequences of not treating are not treating optimism.

We are not treating safely.

We then compared the clinical efficacy benefits of Roxadustat based on the kind of phase three studies over.

He says.

And then we looked at the safety advantages over he says.

And this is all about differentiation on clinical basis.

We also with Astrazeneca believe that Roxadustat as a first in class drug.

And our patented first in class struck of course to state the obvious deserves it innovation premium.

Because we are bringing a transformative new treatment paradigm to China.

That above and beyond the clinical benefit to the patient in a quantifiable unmet medical need.

Also supports the country's policy direction of encouraging innovation.

So we're hopeful that roxadustat could become an example.

Of companies, bringing innovation to China, and expecting a return for that delivery.

We do not see I was just being benchmarked against locally manufactured he said because we think we're highly differentiated product with critical benefits and we believe we deserve an innovation premium.

Obviously, Paul at the end it today, it's about budgetary concerns and budgetary considerations of the Chinese government and affordability for the patient.

So at the end to the day should there be in NRT on negotiations pricing would not just be what we would like to assert the what the country can actually afford so we'd be eager to see what that balances should there be an energy on negotiation, but that is our pricing strategy in terms of what we don't believe it's a fair pricing for Roxadustat.

Thanks for taking your questions.

Okay and your next question comes from that show, beating your line is open.

Hi, Joe perhaps your me that on your end.

Sorry about that Okay can you hear me now.

We can drill.

Right. Okay. So that's my first question is on the quality of life benefit from the phase three program.

I believe that there was some initial data presented at the top line data, but then I didn't see anything on quality of life Sun.

Should we still consider cardio life effect to be in line with a topline press release, and how important well quality of life data from the phase three program before marketing the drug.

[noise] Joe is this a quick questions a yes or our data is consistent with what we had up a piece of a reporter and top line.

So we just had so much to put together for the S.N. than we do look forward to to present, the result in future conferences and publications.

As you know a one of the manifestations of anemia is for patients is fatigue.

On a alaskan quality of life. Thank you.

And then maybe one other question can you talk about the indication you plan to pursue for Roxadustat. Thanks.

Ah yes so.

So we and our partners believe thoughts are roxadustat has the potential to become the immediate drug for various kinds of thought Oh saw anemia beyond CKD and so as we have presented we already have ongoing trial in Mds and media.

And thought in chemotherapy induced anemia.

There are additional anemia pipes that are in considerations such as CEMEA in multiple myeloma patients under a new idea of inflammation.

Are.

There has been expensive effort to evaluate all these pipes of anemia and more.

Thank you.

Okay and there are no questions at this time.

In closing I'd like to thank you for your attention support.

I also want to take the senior management team and all the dedicated employees with fiber, Germany, you exit in China, who are committed to bring novel innovative medicines to patients around the world.

During the boom that Tom set for the company 25 years ago.

Thank you.

Yeah.

Thank you ladies and gentlemen. This concludes today's conference. Thank you for participating you may now disconnect.

Welcome to the Fibrogen third quarter 2018 financial results Conference call.

Aaron and I'll be your operator for today's call.

At this time approaches pence Arnie listen only mode. Later, we'll conduct a question and answer session.

During the question and answer session. If you'd have a question. Please press Star then one on your catch talked about please note that this conference is being recorded I will now turn the call where do you Michael Palin Michael you may begin.

Thank you Aaron and good afternoon, everyone. Thank you for joining our call today, we'll be reporting financial results corporate updates for the third quarter of 2019.

Joining me today on the call or Jim <unk> interim Chief Executive Officer, Dr. Peony, Yu, Chief Medical Officer, Ms., Chris Chunk Senior Vice President I try not Dr. Allianz crew Shockey senior Vice President clinical development and drug safety and Pharmacovigilance, Mr. Packet for now Chief Financial Officer I.

Following our prepared remarks, Jim will discuss upcoming milestones and we'll then open the call. The Cuban <unk>. During this call may make forward looking statements regarding our business, including our collaborations with doctors that are kinda stylists financial guidance. The initiation enrollment design conduct a result of clinical trials or regulatory strategies and potential regulatory results.

Our research and development activities and certain other business matters.

The risks and uncertainties regarding our business and statements made on the call today as well as factors beyond our control that may cause differences between current expectations and actual results. We refer you to our annual report on Form 10-K for the fiscal year ended December 31st 2018 to a quarterly report on Form 10-Q for the quarter over quarter ended September Thirtyth 2019.

Filed with the Securities Exchange Commission copies of these filings maybe found in the Investor section of our website.

We undertake no obligation to update any forward looking statement, whether as a result, the new information future development or otherwise.

For today's call includes remark from fiber just management team and then we'll open the lines just take your questions. The press release reporting our financial results and business update and at what comes from today's conference call can be found only investors section of the Barberton website at Www Fibrogen Dot com and.

The webcast will be available for 30 days from today's date and with that and with that I'd now like to turn the call over to our interim CEO Jim Shack.

Thank you Mike. Thank you all for joining us today.

During today's call I will give you an overview of our third quarter results and recent accomplishments Dr. Peony. Your will then give a review of the Roxadustat data from the Americans insight into project bidding, which just wrapped up yesterday.

Following that Chris John will update you on our trying to efforts Dr. Elliot's Khrushchev GE will give a horrible map update and Pat Cotroneo will discuss our financials, then I'll provide some closing comments and open the call to questions.

First I want to take a moment to acknowledge with a great sense of loss. The recent an unexpected passing of fiber <unk> founder and long term chairman and CEO Tom though.

Tom with them at a vision determination that leadership and was deeply committed to innovation.

We have fibrogen are deeply embedded in them.

Tom founded fiber to the 1993 with division a pretty fibrosis at a time when there was no hope for the disease category.

The company for over 25 years, and established a culture and a team driven to support his vision motivated by his commitment to improve the lives of those suffering from conditions with no satisfactory therapeutic options.

In foundry Fibrogen, Tom assembled global scientific leaders in areas critical to the understanding your fibrosis and a byproduct disease mechanism ultimately, providing the basis for pamrevlumab and through the export exports exploration of full hydroxylase enzyme activity the basis for Roxadustat.

Tom was intimately involved in the discovery development of Roxadustat, and Pamrevlumab and position the company for great success, given the breadth of the application for both compounds.

Its contribution as a pioneer in the biotechnology industry will be measured by the lives that he has and will continue to touch that's fibrogen continues to develop medicines for unmet medical needs. The Fibrogen Board and management team are committed to fulfill and build upon Tom's vision.

As you all saw last month, the 2019 Nobel Prize and physiology or medicine was awarded the three position scientists for the research and the how self and talk to John and how they function the low oxygen conditions are hypoxia.

The collective contributions of Dr. Bill K, one of the Dana Farber Cancer Institute, Sir Peter Radcliffe or the University of Oxford, and Dr., Greg Semenza, John Hopkins University School of Medicine identified the pathway by which sells detect oxygen to respond to hypoxia.

This terminal sciences paved the way for promising new strategies to fight anemia cancer and many other diseases.

Fiber disposal is fortunate to work closely with Bill Kalen collaborator a member of the company's scientific Advisory board for nearly two decades.

Today, Roxadustat is but first medication the world, which applies this groundbreaking science.

Dr. Bob problems Arnaud stated at the American Society Nephrology last week. This is a great example of cutting edge science would be from bench to bedside.

Roxadustat has already approved in China for the treatment of anemia associated with chronic kidney disease and in Japan for CKD patient on dialysis.

We also currently preparing regulatory submissions for the U.S. and Europe .

Last week during the American decided nephrology kidney week 2019, Fibrogen and our partners was felt wasn't Astra zeneca presented roxadustat data from our phase three program as well as pool cardiovascular safety and efficacy results.

The pool data kicked off as a high impact critical trials session with a packed room of almost 2000 people.

I Wonder Prologis called it the largest proud for the media presentation in well over a decade.

Instead of global studies covered the spectrum of chronic kidney disease anemia, and is believed to be the largest and most comprehensive study population ever reported with over 8000 patients.

Details of the data presented it can be found on our website and in our press release from last Friday.

Our studies assess cardiovascular safety in dialysis and non dialysis dependent patients use the endpoints of major adverse cardiovascular events known as mace and mace, plus which adds hospitalization due to unstable angina congestive heart failure.

The poor results show that Roxadustat cardiovascular safety was comparable to placebo in non dialysis dependent patients.

And then dialysis dependent patients Roxadustat did not increase the risk of mace and reduce the risk of mace plus compared to you quite an alpha.

Leading product currently used to treat this population.

Finally, as a subgroup of dialysis patients, who recently started dialysis referred to as incident dialysis patients roxadustat reduced mace by 30% and base plus by 34% compared to reported an alpha.

Roxadustat achieved the primary people going up hemoglobin efficacy endpoints in all of these groups.

Of note Roxadustat was shown to raise hemoglobin levels, regardless of iron status, a baseline in patients who required no supplementary IB iron and in patients with inflammation group, it's difficult to treat with current therapies.

Having an oil product with the safety and efficacy profile can offer patients with <unk> in EMEA of chronic kidney disease and their doctors a treatment. Unlike anything currently on the market in the U.S. or Europe .

Let me briefly mentioned a few other highlights from the border.

We initiated our phase three Pamrevlumab program.

During the first patients in our idiopathic pulmonary fibrosis or IP F. trial as well as our study study in locally advanced pancreatic cancer.

Our phase two IP AF trial was published in the Lancet respiratory Medicine journal enemy accompany editorial per vessel April wells, the Royal Brompton hospitals stated.

Conclusion, it's difficult to imagine more encouraging phase two results of a novel drug for IPO.

In China, we booked our first roxadustat product revenue anywhere in the world and we continue to prepare for the full market launch with our 50 50 partner Astra Zeneca.

In September Fibrogen Roxadustat, one to 2019, you like prize for innovative drug with the highest clinical value in China.

I think you'll agree with me, it's been a very very accomplished quarter.

Now I'll turn it over to Pony, who will give you more in depth discussion of Roxadustat and the data from the has been meeting.

Thank you Jim last week Fibrogen partners presented rocket fuel for phase three we felt at the annual American Society of Nephrology meeting, which included over 13000 kidney professionals at the Nephrologist share excitement of the potential game changer in AMEA therapy.

Based on strong scientific foundation today, I would like to review the highlights the pool analyses included data from the phase three trials, including over 8000 patients and encompass over 13000 patient exposure I guess I study to evaluate the three patients.

Populations non dialysis dependent dialysis dependent.

And then dialysis, which is a subgroup of patients.

Recently started dialysis lift in four months of studies participation.

Pardon oddly south of the following safety endpoints.

Major adverse cardiovascular events mace endpoint consist of death due to all costs. This nonfatal myocardial infarction and nonfatal stroke.

Maybe plus consists off that threed mace events, plus hospitalization due to heart failure or unstable angina.

All cause mortality is simply all death.

Due to any costs.

To maintain objectivity and consistency.

The event empties cardiovascular endpoint, what adjudicated by independent adjudicators blind that to treatment assignment.

The time to you've done analyses are conducted based on putting strategy and analytical approach is agreed with the SDK and the time to mace is the primary safety endpoint in the U.S. supported by results up Mays Platts.

Which is recognized as Anne.

That's an endpoint in the nephrology community.

Non dialysis.

Well rocks abuse that was compared to placebo, which is the gold standard in safety assessment Roxadustat was comparable to placebo in Mays amazed parts of this using a commonly applied non fuel rod peak margin of 1.3.

In dialysis patients Ross the deals that we deal with may surprise by 14% compared to pull the pen Alpha and had no increase will make compared to the ball using a commonly applied eni margin of 1.3.

And then by outlets that's brought the do stuff how does that.

Got it.

Hi side, lower would have made and a 34% lower with up may surprise that you bought.

Let's discuss the rest of the efficacy and safety results starting with non dialysis.

40, 270, plus CKD patients.

Well it into that please.

Phase three non dialysis studies compelling rocks that things that to placebo GMP study William quota CKD stake suite. So.

Five.

Patients.

Well from 42%.

For.

The state five there anemia tends to be more severe.

With that much event.

Chronic kidney disease and they have been generally excluded from client logic CKD anemia studies off yes safe.

Similarly quota patients with a range of Iowans boys.

With 40% of study patients not on Ibrance eliquis at baseline and does the what ineligible for Isa treatments.

Based on the current you saw the ball.

Lots of things that met the primary efficacy endpoint up name change from baseline to average hemoglobin overbooks plenty to 52.

Which.

I'm fighting each off the green individual phase two studies and the analyses, which lots of dance that was superior to placebo, regardless of CKD severity with brightness off the verity of ammonia at baseline and Weve got less up I won't be question status.

[noise] Roxadustat hepatitis C is the company biod, 81% listen adoption.

With a rescue my which includes Ivy Iran.

Yeah, and transfusion on a 74% reduction in the with the all right, but south transfusion, but P value of 0.001.

P value less that.

Importantly.

In comparison to placebo Roxadustat patients also show a slower decline you, Jeff I was with a measure of kidney function.

Patients with base in patients with baseline you Jeff are all 15 on all higher during the first year of treatment.

One year declining EG fight in rock for patients was.

2.8, which is significantly less than that decline in placebo patients. All 4.4, what the tremendous signs up 1.6 M. P value will have things emails and that this represents a 38% reduction in VGF decline relative to your.

Placebo.

Turning to cardiovascular safety.

In the CKD Mumbai outlets at the pool based on I T analysis, Wassa passed out whats comparable killed placebo.

For reference here that have that base shelf.

May Casa ratio up 1.8, with 95% confidence interval appoint mindful and 1.24 month, plus hazard ratio of 1.0 for what.

Confidence in the bullet 0.91, and 1.18, all cause mortality how they show up 1.6, we're confident in about a 0.91 and 1.23.

We have received questions on the individual components of cardiovascular composite endpoint in non dialysis.

The most interest in stroke.

This is most likely because of the tree study on Bob about a 10 that we felt it in the USA label restriction units, you can non dialysis and by outlets as patients.

I want to be clear from the outset, we believe the data from the individual components of maze amazed plotting. The Roxadustat program are consistent with that we felt in the overall analyses stated another way people leave the least falls into it.

The vigil compartments our comparable.

Two placebo in non dialysis.

It's also true for that by outlets as the pool.

Before we delve into details I want to remind you that the roxadustat non dialysis program, what's power for assessing the amaze composite endpoint and not the individual components to give a sense a magnitude in the Roxadustat program.

Represent only 10% off the may be bad.

In the non dialysis pool, and the Oh, the Benz offer great and Roxadustat, it's comparable to a placebo whichever 1.2 per 100 patients yes.

That does that bridge, that's 1.1 in placebo arm hazard ratio of 1.2 team with 95% confidence <unk> 0.80 and 1.86.

As a reminder, due to treat study.

It was the fence right of stroke in Bobby Portend, what price sad off.

Think about what has the ratio of 1.9 team.

And 95% confidence interval of 1.38 and 2.18.

The rest of the main plus components in our non dialysis pool is as follows.

All cause mortality a house so based on 1.6 confidence interval up quite nylon and 1.23, what you mean stated earlier.

Oh I am I.

Uh huh so they show of 1.28 comparable to the end of <unk> 0.9, and 1.84 unstable angina, requiring hospitalization what has already show a 0.49 and confidence in the <unk> 0.19 and 1.27.

Finally.

Congestive heart failure requiring hospitalization.

I would you say well, which is important in CKD patients haphazardly show off 0.89.

Comparable into fall off a 0.72 and 1.12.

Based on the composite endpoints applying to may or May plus.

All cause mortality and the individual components. The overall cardiovascular safety of rocks abuse that is comparable to placebo.

The biology that depends on patient pool consists of 30 880 patients who were randomized one to one to receive Roxadustat. All you pull it alpha Anthony dialysis phase three studies the primary efficacy endpoint.

Oh no change in hemoglobin from baseline to 28 to 52 was met.

Each individual study and the pool analyses.

Rocks abuse that achieve higher hemoglobin level that active comparator, if you pull with an alpha that's my thought was seen in patients with or without inflammation as measured by CRP.

With similar Roxadustat bodes requirement, regardless of the inflammation status.

Roxadustat treated patients receiving a less Ivy island that you Paul patience, while transparent saturation or T sat and measure off I would start in the body world comparable between the two treatment arms.

In addition, when compared with Paul Ross abuse that to the patients having lower red blood cell transfusion risk then people to that patients hazard ratio off 0.8 champion value appoint own for sex.

The combination of findings about reflects the benefits of coordinate with third party service with Roxadustat as treatment will follow that you're more efficient island utilization.

Lower transfusion requirement and 10 potentially overcome Lisa I pulled responsiveness.

Turning to cardiovascular endpoint analyses offset by outlets as a pool.

In may and all cause mortality roxa deals that have no increase this relative till you Paul.

The amazing.

Wassa do that had a 14% reduction.

Yes.

Compared to equal.

I would like to point out.

Incidence rate of each of the individual made plus components.

In biology says.

Numerically lower roxadustat than equal.

Finally.

Let's talk about.

The exciting patient population.

Incident, dialysis, which is a pre specify somewhat offset by Alice's dependent pool.

Here, we studied 1500 26 O'neil.

I was with patients who come most treatment within four months before study participation.

Our true that up to three years with an average treatment duration, the one and a half year.

In the incident dialysis pool in comparison to eat potent alpha.

Lots of deals that treatment resulted in a 30% reduction in the resumes.

34% reduction in the resumes plus what they're trying to far lower.

Wrote off that.

These results such as opposed to long term safety benefits little selecting rocks abuse that when initiating EMEA therapy in dialysis patients.

To evaluate the merits of Roxadustat. It is important to put together an overall picture taken into account efficacy and safety.

Yes.

If this drought has the potential to improve.

Treatment in CKD patients.

Our answer is yes.

Non dialysis, our phase three program show Roxadustat treatment.

Correct that Amelia effectively regardless of Ireland, repletion, and we do I misspoke rescue use all blood transfusion.

Wow, Okay, no slowing down but declined in kidney function in patients with me, Jeff far greater than or equal to 15, while may or may plus that all cause mortality risk, we're probably football she will close sample the gold standard.

Because of the safety when laid it.

You know was fiction of yesterday, coupled with the island with pension requirement and be inconvenience. Our parenteral administration requirements. Currently there is little new as of yesterday in non dialysis patients.

He was audio has reported that only 15% of patients entering dialysis.

Had lucy prior treatment.

[noise] if approved.

Lots of things that could deliver the therapeutic benefits [noise].

Let the convenience of a pill.

Yes, it looks requires frequent injection at the Doctor's office.

In addition to the favorable efficacy and safety characteristics, but convenient dosing of all meditation Amrica Mvil Opus financial and Pombo done something stations move to a stock and check the medicine, we believe rocks against that has the potential pill.

Improved treatment access and patient compliance.

Therefore, we believe we have an unprecedented opportunity to expand and yet therapy to the millions of non bioflo since the creation cost the ammonia go on that to us.

In dialysis currently but this season on the choice of ammonia agent is generally made at the early periods of biologists treatments.

With a 30% reduction in May so, yes, and a 34% reduction amazed plus with compared with important alpha incident dialysis patients. We believe rocks advanced that could be viewed as the same for option for patients initiating.

Chronic dialysis, while benefiting from the robust efficacy in patients with or without inflammation, what the less Ivy Ireland youth.

And the lower transfusion rate compared to people in the dialysis patients.

We are privilege to have an opportunity to potentially introduce a new standard for anemia therapy for CKD patients would roxadustat.

A first in class agent base on Nobel Women Science.

We believe these compelling efficacy results with demonstration of clinical benefits.

Company I'd be above safety results.

Could serve as strong basis for marketing approval.

Both the U.S.

Europe and other countries in the world.

Working with our partner Astra Zeneca may have made substantial progress in preparing end da fourth CKD anemia in patients on dialysis and I mean patients not on dialysis.

We plan to submit the NDA for both indications.

So a year and we're working closely with us fell less our European partner and then.

Expects to file the M.A. for both indications in the first quarter of 2020.

Encouraged by the safety and efficacy results in CKD, we continue to expand treatment often yet other than technologies.

MBS, we'll have to ongoing clinical study.

A phase three U.S. global study in transfusion dependent Mds patients and they face to face study in non transfusion dependent mds patients in China.

Something [laughter] Black Friday, we solved all see open label leave in portions demonstrating Ross it seems that efficacy in Mds patients will be presented in an almost fashion on the upcoming American society of Hematology meeting.

Orlando.

Next month.

We have I follow spotted a phase two U.S. study of Roxadustat for treating chemotherapy induced anemia would you we believed to have much opportunity to address the a met me, although a large patient population.

Our founding CEO , let.

Hi, I'm hearing.

<unk> ph I felt anemia therapy.

We are committed to carry on probably meth legacy to develop innovative medicines to improve patient care.

I'd now like to turn the call over to of course Charles.

[noise] takes pony.

It has been uneventful quarter for us in China publication of data from that to China only phase three studies in the New England General Medicine was a landmark event, which were celebrated in China with much enthusiasm.

The Chinese nephrology community envisions itself as leading the way internationally in the adoption of a transformative new paradigm for the treatment of anemia in CKD.

We think that's your if the China label to include non dialysis, our partnership with Astrazeneca is serving us well were able to leverage the significant commercialization capability and launch experience of what is now the largest multinational pharma in China with coverage at over 6000 hospice.

Those that represent the vast majority of the potential market for Roxadustat.

Five because in China has responsibility for medical affairs, and we too have expanded a key opinion leader coverage and evidence generation activities over the last few years from the original 30 phase three clinical trial sites can now over 300 meeting hospitals and counting.

As a joint team, we continue to advance our efforts in market development distribution reimbursement and gaining listings in hospitals.

China, that's the first watch market for rocket used that has given us some very encouraging early signals about prescribers and patients receptivity indicated which are helping us calibrate the scale and scope, although ambition for the market.

Nothing the different segments of the potential patiently universe.

In dialysis the installed base of over 600000 patients now the single largest single country dialysis population of the world exceeding that of the United States.

This is a substitution market for roxadustat.

Treatment of anemia is well established but only one fifth of patients are treated to the target hemoglobin of 11.

There continues to be double digit growth in dialysis after accounting for death.

Nearly 100000, new patients come onto dialysis each year. They represent you candidates for Roxadustat and many have no prior east experience.

Within dialysis is approximately 100000 patients or 14% who are treated pod peritoneal dialysis PB instead of hemo dialysis HD.

We believe this segment is particularly well suited for Oh therapeutic like Roxadustat because patients receive PD treatment at home.

Finally, the non dialysis segment is even bigger in patient count.

But you say use is much less established we believe as an oral therapy roxadustat has the opportunity to greatly expands the addressable market.

We expect to know by the end of 2019 abrupt studies that will be included in the updated national reimbursement Druck list or NRG out.

Inclusion would be and important inflection point for the business as you would greatly increased patient affordability accelerate hospital listing and expand overall market adoption.

This remains a stretch goal has historically been and our deal cycles, where farther apart in time and drugs. The other market for a few years before inclusion.

India that lasted USAT is not a bit in this rally reimbursement would be a top priority for us in 2020.

We look forward to keeping you updated I'd exciting market opportunity inside of us in China.

With this I'll turn it over to Lvs to describe this development in time robinette.

Thank you, Chris and good afternoon.

I'd like to start with.

Introduction of Pamrevlumab.

It is it's the first in class fully human monoclonal antibody that.

Thats inhibit activity of connective tissue growth factors, although no one's asked CTGF.

It's a critical negotiators have the progression of fibrosis and fiber broadband to diseases.

I'm happy about is currently in phase three clinical development.

For the treatment of both idiopathic pulmonary fibrosis IPO.

And the sector, both locally advanced pancreatic cancer.

Although no one's help l. APC.

Another rabbits in the phase two for the treatment of the Shen muscular dystrophy as non ambulatory patients.

These.

Third quarter 2018 financial results Conference call. My name is Aaron and I'll be your operator for today's call. At this time all participants are any listen only mode. Later, we'll conduct a question and answer session. During the question and answer session. If you'd have a question. Please press Star then one on your Touchtone phone. Please note that this conference.

Is being recorded.

Ill now turn the call over to Michael tongue, Michael you may begin.

Thank you Aaron and good afternoon, everyone. Thank you for joining our call today, we'll be reporting financial results and corporate update for the third quarter of 2019.

Joining me today on the call or Jim <unk> interim Chief Executive Officer, Dr. Peony, Yu, Chief Medical Officer, Ms., Chris Chunks, Senior Vice President, China, Dr. Elliot's crew Shockey, Senior Vice President clinical development, and drug safety, and Pharmacovigilance and Mr., Pat Cotroneo, Chief Financial Officer, following our prepared remarks, Jim will discuss upcoming Myles.

And we will then open the call documenting during this call you may make forward looking statements regarding our business, including our collaborations with Astrazeneca and Astellas financial guidance. The initiation enrollment design conduct and result of clinical trials or regulatory strategies and potential regulatory results, our research and development activities and certain other business.

Matters.

The risks and uncertainties regarding our business and statements made on the call today as well as factors beyond our control that may cause differences between current expectations in actual results. We refer you to our annual report on Form 10-K for the fiscal year ended December 30, Onest 2018 into a quarterly report on Form 10-Q for the quarter over quarter ended September Thirtyth 2019 fall.

As with the Securities and Exchange Commission copies of these filings maybe found in the Investor section of our website.

We undertake no obligation to update any forward looking statement, whether as a result of new information future development or otherwise the format for todays call includes remark from fiber does management team and then we'll open the lines to take your questions. The press release reporting our financial results and business update in a webcast of today's conference call can be found on the investors section of the fabric.

Website at Www Fibrogen Dot com.

The webcast will be available for 30 days from today's date and with that and with that I'd now like to turn the call over to our interim CEO Jim check.

Thank you Mike and thank you all for joining us today.

During today's call I will give you an overview of our third quarter results in recent accomplishments Dr. Peony Yu will then give a review of the Roxadustat data from the Americans insight into frolic, GBT, which just wrapped up yesterday.

Following that Chris churn will update you on our China efforts Dr. Elliott to shock GE will give a per mobile map update and Pat Cotroneo will discuss our financials, then I'll provide some closing comments and open the call to questions.

First I want to take a moment to acknowledge with a great sense with loss the recent and unexpected pounds of fiber to the founder and long term chairman and CEO Tom now.

Tom was amount of vision determination and leadership and was deeply committed to innovation.

We have fibrogen are deeply embedded to him.

Tom founded Fibrogen, a 1993 with division of treating fibrosis at a time when there was no hope for the disease category.

The company for over 25 years, and established a culture and a team driven to support his vision motivated by his commitment to improve the lives of those suffering from conditions with no satisfactory therapeutic options.

In foundry Fibrogen, Tom assembled global scientific leaders in area is critical to the understanding of fibrosis and the fiber optic disease mechanism ultimately, providing the bases for pamrevlumab and through the export exports exploration of pro hydroxylase enzyme activity the basis for Roxadustat.

Tom was intimately involved in the discovery development of Roxadustat, and Pamrevlumab and position the company for great success, given the breadth of the application for both compounds.

His contribution as a pioneer in the biotechnology industry will be measured by the lives that he has and will continue to touch as Fibrogen continues to develop medicines for unmet medical needs.

The Fibrogen Board and management team are committed to fulfill and build upon Tom's vision.

As you all saw last month, the 2019 Nobel Prize and physiology or medicine was awarded the three physician scientists for the research into how sell since oxygen and how they functions and low oxygen conditions are hypoxia.

The collective contributions of Dr. Bill tail end of the Dana Farber Cancer Institute, Sir Peter Radcliffe or the University of Oxford, and Dr., Greg Semenza, John Hopkins University School of Medicine identified the pathway by which sells detect onto didnt respond to hypoxia.

This seminal science has paved the way for promising new strategies to fight anemia cancer and many other diseases.

Hi, Richard is frozen is fortunate to work closely with Bill Kalen collaborator and member of the company Scientific Advisory Board for nearly two decades.

Today Roxadustat is the first medication the world, which applies this groundbreaking science that Dr., Bob Provenzano stated at the American Society Nephrology last week. This is a great example of cutting edge science moving from bench to bedside.

Roxadustat is already approved in China for the treatment of anemia associated with chronic kidney disease and in Japan for CKD patients on dialysis.

We're also currently preparing regulatory submissions for the us in Europe .

Last week during the American Society, Nephrology kidney week, 2019, Fibrogen and our partners. This fellas and Astra Zeneca presented Roxadustat data from our phase three program as well as pooled cardiovascular safety and efficacy results.

The pooled data kicked off assets high impact clinical trials session with a pack room of almost 2000 people.

I Wonder prologis called at the largest crowd from anemia presentation in well over a decade.

This set of global studies covered the spectrum of chronic kidney disease anemia, and is believed to be the largest and most comprehensive study population ever reported with over 8000 patients.

Details of the data presented can be found on our website and in our press release from last Friday.

Our studies assessed cardiovascular safety in dialysis and non dialysis dependent patients use the endpoints of major adverse cardiovascular events known as mace and mace, plus which adds hospitalizations due to unstable angina and congestive heart failure.

The poor results show that Roxadustat cardiovascular safety was comparable to placebo in non dialysis dependent patients.

And in dialysis dependent patients Roxadustat did not increase the risk of mace and reduce the risk of mace plus compared to your point and alpha the leading product currently used to treat this population.

Finally in the subgroup of dialysis patients, who recently started dialysis referred to as incident dialysis patients roxadustat reduced mace by 30% inmates plus by 34% compared viewpoints and alpha.

Roxadustat achieved the primary he will go in F hemoglobin efficacy endpoints in all of these groups.

Of note Roxadustat was shown to raise hemoglobin levels, regardless of iron status, a baseline in patients who required no supplementary Ivy iron and in patients with inflammation, a group that it's difficult to treat with current therapies.

Having an oil product with this safety and efficacy profile can offer patients with that anemia of chronic kidney disease and their doctors a treatment. Unlike anything currently on the market in the us or Europe .

Let me briefly mentioned a few other highlights from the quarter.

We initiated our phase three Pamrevlumab program enrolling the first patients in our idiopathic pulmonary fibrosis or IP ETF trial as well as our study study in locally advanced pancreatic cancer, our phase two IP AF trial was published in the Lancet respiratory Medicine journal and any accompany editorial per vessel April wells of the world.

Compton hospitals stated.

In conclusion, it's difficult to imagine more encouraging phase two results of a novel drug for IPO.

In China, we booked our first roxadustat product revenue anywhere in the world and we continue to prepare for the full market launch with our 50 50 partner Astra Zeneca.

In September Fibrogen Roxadustat, one to 2019 do shoe Lake prize for innovative drug with the highest clinical value in China I.

I think you'll agree with me, it's been a very very accomplished quarter.

Now I'll turn it over to Pony, who will give you more in depth discussion of Roxadustat and the data from the us in meeting.

Thank you Kim last week, Fibrogen, and our partners pretty damn good MOSFET do for phase three we filed at the annual American Society of Nephrology meeting, which include that over 13000 can be professionals as the nephrologist share excitement of the potential game changer anemia.

RFP based on strong scientific foundation today, I would like to review the highlights the pool analyses, including data from six phase three trials, including over 8000 patients and then context over 13000 patient exposure yes.

Studies evaluating the patient populations non dialysis dependent.

Hi, this is dependent.

And incident dialysis center, which is a subgroup of patients.

Recently started dialysis linked in four months offsetting participation we reported on the south of the following safety endpoints.

Major adverse cardiovascular events may endpoint consist of death due to all casus nonfatal myocardial infarction and nonfatal stroke.

Maybe plus consists of that Threed mace events, plus hospitalization due to heart failure or unstable angina.

All cause mortality is simply aren't that due to any costs.

To maintain objectivity and consistency.

Events empties cardiovascular endpoint acute Acadia independent adjudicators blinded to treatment assignment.

The time to even analyses are conducted based on putting strategy and analytical approach is agreed with the FDIC and the time to mace is the primary safety endpoint in the US supported by results of Mays plants.

Which is recognized as an important endpoint in the nephrology community.

In non dialysis.

Where roxadustat less compared to placebo, which is the gold standard in safety assessment Roxadustat was comparable to placebo in Mesa made parts of this using a commonly applied nine with your IP margin of 1.3.

In dialysis patients roster deals that reduced the Louis may surprise by 14% compared to important Alpha and had no increase most up may compared to people using a commonly applied eni margin of 1.3.

Incident dialysis capacities that had a threat.

Had a 30% lower risk of mace and a 34% lower risks that may surprise that you Paul.

As discussed the rest of the efficacy and safety results starting with non dialysis.

40, 270, plus CKD patients.

Well into the three.

Phase three non dialysis study comparing rocks the things that to placebo in these studies to be included CKD stage, three four and five.

Patients.

Our from 42% or CKD stage, five fair anemia tends to be more severe.

Let them more event.

Chronic kidney disease and they have been generally excluded from pie and large CKD anemia studies off yes phase.

Similarly, we include a patients with a range of iron stores.

With 40% of study patients non Ivan replete at baseline and pass through what ineligible for Isa treatments.

Based on the current decelerate Paul.

Lots of things that met the primary efficacy endpoint of new change from baseline to average hemoglobin over weeks plenty to 52.

Rich.

I'm fighting each after three individual phase two studies and the pool analyses in which about cities that was superior to placebo, regardless of CKD solidarity with got less our fidelity of anemia, a baseline and Weve got less off highway depletion status.

[noise] Roxadustat efficacy is accompanied by an 81% this reduction in use on rescue treatment, which includes IB, Iran, Lisa and transfusion and a 74% reduction in the rest of wrap up sell transfusion repeat.

Value 0.01.

P value less then.

Importantly in comparison to placebo Roxadustat patients also show a slower decline in VGF I was just a measure of kidney function.

Patients with base in patients with baseline fr Alpha team on a higher.

During the first year of treatment.

One year.

Climbing EG fight in Roxa patients was a 2.8, which is significantly less than that decline in placebo patients a 4.4, but that stream in defense of 1.6 and P value has the zeros in that this represents a 38% reduction.

MTF decline relative to placebo.

Turning to cardiovascular safety.

In the CKD non dialysis pool based on I T. T analysis watts against that was comparable kill placebo.

For reference here the hasn't based shelf.

Mace hazard ratio of 1.8, with 95% confidence interval 0.94, and 1.24 may surprise hazard ratio of 1.0 for what.

Competent into 4.91 and 1.18 all cause mortality has racial up 1.06, we're confident end of our 0.91.

And 1.23 [noise].

We have received questions on the individual components of cardiovascular composite endpoint in non dialysis with the most interest in stroke.

Well this is most likely because after three study on bumper play attend that we found that in the USA labor risk action in this year in non dialysis and dialysis patients.

I want to be clear from the outset, we believe that data from the individual components of maze amazed plus in the Roxadustat program are consistent with that we felt in the overall analyses stated another way people leave the results in that.

Individual components are comfortable.

Two placebo in non dialysis.

This is also choose for that by outlets as Paul.

Before we delve into details I wanted to remind you that roxadustat non dialysis program, what power for assessing the Mays composite endpoint and not the individual components to give a sense a magnitude in the Roxadustat program stroke represents only 10%.

After mace events in the non dialysis pool and the incidence rate in Roxadustat is comparable to placebo whichever 1.21.

100 patients yes.

Roxadustat versus 1.1 in placebo arm hazard ratio of 1.2 team with 95% confidence interval, a 0.80 and 1.86.

As a reminder.

To treat study the incidence rate of stroke empower people attend what's twice sad off.

So simple what hazard ratio of 1.9 team.

And 95% confidence interval of 1.38 and 2.18.

The rest of the amazed plus components in our non dialysis pool is as follows.

All cause mortality.

So based on 1.6 confidence interval, a 0.91 and 1.2 or three what should we stated earlier.

Am I.

Hazard ratio of 1.28 confidence interval, a 0.9 and 1.84 unstable angina, requiring hospitalization wed have surveys show, a 0.49 and confidence interval, a 0.19 and 1.27.

Finally.

Congestive heart failure requiring hospitalization.

What you say imports, which is important in CKD patients has hazard ratio of <unk> 0.89.

Confidence interval of <unk>, 0.72, and 1.1 too.

Based on the composite endpoints are trying to make nice price.

All cause mortality and the individual components. The overall cardiovascular safety of Roxadustat is comparable to placebo.

[noise] dialysis dependent patient pool consists of 30 880 patients who are randomized one to one to receive Roxadustat. All you pull attorney Alpha in Threed dialysis phase three studies the primary efficacy endpoint.

End of mean change in hemoglobin from baseline to week 28 to 52 was met in each individual study and the pool analyses.

Roxadustat achieve higher hemoglobin level that active comparator of Newport, an alpha definitely felt was seen in patients with or without inflammation as measured by CRP.

With similar Roxadustat those requirements, we've got less severe inflammation status.

What roxadustat treated patients receiving a less ivy, Iran than Epo patience, while transparent saturation or T sat and measure off highway store in the body where comparable between the two treatment arms.

In addition, when compared with Paul once it does that to the patients had a lower wrap lifestyle transfusion risk than repo key that patients hazard ratio off point ATM P value appoint all four six.

The combination of findings about reflects the benefits of coordinator ever sold plane says what roxadustat as treatment. We saw the in more efficient island utilization lower transfusion requirement and 10 potentially overcome.

Isa Hypo responsiveness.

Turning to cardiovascular endpoint analyses offset by outlets as pool.

In may and all cause mortality Roxadustat had no increase this relative to you Paul.

In may surprise.

Wassa do that had a 14% reduction and invest.

Compared to people.

I would like to point out the incidence rate of each of the individual major plus components.

In dialysis on numerically lower inbox, it seems that than equal.

Finally, let's talk about.

The exciting patient population.

Incident, dialysis, which as a pre specify subgroup after dialysis dependent pool.

Here, we studied 1500 26 new.

Hi, Alex its patients who commenced treatment within four months before study participation and work through that up to three years with an average treatment duration of one and a half year.

In the incident dialysis pool in comparison to important alpha.

Lots of deals that treatment resulted in a 30% reduction in the rest of mace and a 34% reduction in the resumes class what they're trying to far lower.

Most of that.

These missiles suggests potential long term safety benefits in selecting roxadustat when initiating EMEA therapy.

In dialysis patients.

To evaluate the merits of Roxadustat. It is important to put together an overall picture taken into account efficacy and safety.

And pass.

If this drought has the potential to improve EMEA treatment in CKD patients.

Our answer is yes.

Non dialysis, our phase three program show Roxadustat treatment.

Corrected EMEA effectively regardless of island repletion and reduced this of rescue use all blood transfusion.

While also know slowing down the decline in kidney function in patients with new jafar greater than or equal to 15, while may or may plus and all cause mortality risk we're comfortable to placebo the gold standard.

Because of the safety related.

Okay, no restriction of yesterday, coupled with the island retention requirement and the inconvenience.

Parental administration requirement currently there is little use of USA in non dialysis patients as us audio through product that only 15% of patients entering dialysis.

Had received prior Isa treatment.

[noise], if a pool of lots of deals that could deliver at a therapeutic benefits [noise].

With the convenience of apparel.

Right yesterday, which requires frequently injection at the Doctor's office.

In addition to the favorable efficacy and safety characteristics. The convenient dosing of all meditation am removal of financial and time burden something stations meet to stock.

Inject the medicine, we believe rocks at these that has the potential to improve treatment access and patient compliance.

Therefore, we believe we have.

It's a dentist opportunity to expand anemia therapy to the millions of non bioflo since the patients calls and media go and address.

[noise].

In dialysis.

I made that decision on the choice of EMEA agent is generally made at the early periods of dialysis treatment.

With a 30% reduction in may.

Yes, and a 34% reduction amazed prosperous compared with important alpha in incident dialysis patients. We believe rocks abuse that could be viewed as a same for option for patients initiating chronic dialysis, while benefiting from them.

Robust efficacy in patients with or without inflammation, what the less Ivy Ireland youth.

And lower transfusion rate compared to people in the dialysis patients.

We are preselect to have an opportunity to potentially introduce a new standard for anemia therapy for CKD patients what roxadustat.

A first in class agent base on Nobel Women's Science.

We believe these compelling efficacy results with demonstration of clinical benefits accompanied by the above safety results.

Could serve as strong basis for marketing approval.

In both the U.S.

Europe and other countries in the world.

Working with our partner Astra Zeneca, we have made substantial progress in preparing M.D.A. for CKD anemia in patients on dialysis and patients not on dialysis.

We plan to submit the NDA for both indications.

Before year end, we're working closely with us fell less our European partner and and expect to file the M.A. for both indications in the first quarter of 2020.

Encouraged by the safety and efficacy results in CKD, we continue to expand treatment off a new yet other in technologies.

In Mds, we have two ongoing clinical studies.

A phase three U.S. global study in transfusion dependent Mds patients and a phase three studies in non transfusion dependent mds patients in China.

Something [laughter] greater Sadie resolve off the open label leave in portion.

Demonstrating philosophies that efficacy in Mds patients will be presented in an all know session of the upcoming American Society of Hematology meeting in Orlando.

Next month.

We have also started a phase two U.S. study of Roxadustat for treating chemotherapy induced anemia, which we believe to have much opportunity to address the unmet needs of a large patient population.

Our founding CEO , let pioneering his ph I fall and menial therapy.

We are committed to carry on Conde Nast legacy to develop innovative medicines to improve patient care.

I now like to turn the call over to Chris Charles.

Thanks, Pete County.

It has been an eventful quarter for us in China publication of data from the two China only phase three studies in the New England General Medicine was a landmark event, which were celebrated in China with much enthusiasm.

Chinese nephrology community envisions itself as leading the way internationally in the adoption of the transformative year paradigm for the treatment of anemia in CKD.

With expansion of the China label to include non dialysis, our partnership with Astrazeneca is serving us well, we're able to leverage the significant commercialization capability and large experience of what is now the largest multinational pharma in China with coverage at over 6000.

In hospitals that represent the vast majority of the potential market for Roxadustat.

Five again in China has responsibility for medical affairs, and we too have expanded our key opinion leader coverage and evidence generation activities over the last few years from the original Sthirty phase three clinical trial sites to now over 300, leading hospitals and counting.

As a joint team, we continue to advance our efforts in market development distribution reimbursement and gaining listings in hospitals.

China as the first watch market for Roxadustat has given us some very encouraging early signals about prescriber and patient receptivity.

Indicators, which are helping us calibrate the scale and scope, although ambitions for the market.

Nothing the different segments of the potential patient you universe.

In dialysis the installed base of over 600000 patients now the single largest single country dialysis population of the world exceeding that of the United States.

This is a substitution market for roxadustat.

Three made of anemia is well established but only one fifth of patients are treated to the target hemoglobin of 11.

There continues to be double digit growth in dialysis.

After accounting for deaths nearly 100000, new patients come onto dialysis each year. They represent you candidates for Roxadustat and many have no prior experience.

Within dialysis is approximately 100000 patients or 14% who are treated on para tonio dialysis PB instead of hemo dialysis HD.

We believe the segment is particularly well suited for an oral therapeutic like roxadustat because patients receive PD treatment at home.

Finally, the non dialysis segment is even bigger in patient count, but easy to use is much less established we believe as an oral therapy roxadustat has the opportunity to greatly expand the addressable market.

We expect to know by the end of 2019 atrocities that will be included in the updated national reimbursement drug list or NRG out.

Inclusion would be an important inflection point for the business as you would greatly increased patient affordability accelerate hospital listing and expand overall market adoption.

This remains a stretch goal as historically, the and our deal cycles, where farther apart in time and drugs to other markets a few years before inclusion.

India that Roxadustat is not emitted indice route reimbursement would be a top priority for us in 2020.

We look forward to keeping you updated I'd excited market opportunity inside of us in China.

With this I'll turn it over to Elliott to describe this developments in Penn Robinette.

Thank you, Chris and good afternoon.

I'd like to start was.

Introduction of Pamrevlumab.

It is it the first in class fully human monoclonal antibody that.

Second hibbett activity of connective tissue growth factors, although no one's CTGF.

It's a critical mediators of the progression of fibrosis and five a broader took diseases.

I'm happy about is currently in phase three clinical development.

For the treatment of both idiopathic pulmonary fibrosis IP Jeff.

And the sector, both locally advanced pancreatic cancer.

Although no one's help l. APC.

Another rabbits in the phase two for the treatment of the Shen muscular dystrophy and non ambulatory patients.

These diseases share a common loyalty of fibrosis involvement.

In each of present, an area of significance and medical needs.

In which these patients face dire prognosis.

I would like to start to an update on IP Jeff.

In July reduced the first patient is that Chris phase three clinical study.

Oh Pamrevlumab inpatient was IPO.

We continue to activate additional sites in this study and engage with our investigator to enroll patients.

We are redoubling, our efforts in improving our processes to bring sites online.

And expect an acceleration over the next few months.

Our focus now is to activate sites.

With the expectation Thats enrollment will accelerate in the year 2020.

In September as Jim mentioned, we announced the Lance hits respiratory medicine publication.

Positive result from the companies have price phase two clinical studies in IP up.

Showing both significant improvement in the primary efficacy endpoint of a b C change from baseline.

And the reduction in disease progression in quantitative lung fibrosis as measured by HRC tea.

On the known I high resolution Cdiscount.

This paper was well received by the medical community at the 2019 European Respiratory Society International Congress.

We are very appreciative and encouraged by this reception.

And this publication the authors reported that Pamrevlumab demonstrated the potential for stabilization of disease.

For the first time in human studies, the potential of reversal of lung fibrosis is some patience.

Like to remind everyone thats as Pamrevlumab has received orphan drug and fast track designation from the F. day for the treatment of five Tcf.

Moving to ally PC.

Our phase two results showed encouraging clinical evidence of potential.

Of Pamrevlumab plus chemotherapy.

To transform and respectable a late this year patient.

In two patients who are eligible.

For surgical resection.

We recently announced that the first patient was divorced and lot. This our pivotal phase three.

Randomized double blind placebo controlled study evaluating pamrevlumab.

Neo adjuvant therapy for Andrus sector gold ally PC patients.

This study will enroll 260 patient approximately.

To receive chemotherapy of Jim serving in our Paclitaxel, who will be randomized either pamrevlumab or placebo.

As you May know this is very sick patient to is limited options.

But the primary endpoint of overall survival at the end of the treatment period.

We will be evaluating the rate of per section as a surrogate endpoint for a potential accelerated approval.

Similar to IPO Pamrevlumab have received both orphan drug and fast track designation from the FDA for the treatment of this disease.

Turning to descend muscular dystrophy.

We will need to adapt the this quarter to discuss the design of our pivotal phase three program in DMD.

We look forward to updating you in the future at this program advances.

Although we plan in the mood future to publish additional data from patients who have completed one year of treatment in our phase two study.

I'm not going up has received orphan drug designation from the FDA for the treatment.

Of DMD.

[noise].

And clinical study in multiple indications on revenue Mab has consistently shown.

Positive efficacy results.

Has demonstrated a good safety and Tolerability profile.

We are pleased to be progressing with the phase three studies.

To fulfill the vision of our late CEO , Tom Mcgough, whose goal and funding Fibrogen was to Threed cyberoptics diseases.

We look forward to updating you on the progress of the Pamrevlumab program in the future.

I will turn now to calls to our CFO , Pat cotroneo or the financial update but.

Thank you Elliot's.

As announced today total revenue for the quarter ended September 32019 was $33.2 million as compared to $29 million for the third quarter of 2018.

For the same period operating costs and expenses were $86 million and net loss was $49.4 million or 57 cents per basic and diluted share as compared to operating costs and expenses of $71.8 million and a net loss of 42.6.

$6 million or 50 cents per basic and diluted share for the third quarter last year.

Included in revenue for the quarter ended Septemberthirty 2019, our first commercial sales of Roxadustat drug product in China.

The related net product revenue was $600000 for the quarter.

Also included in operating costs and expenses for the quarter ended September 30, 2019 was an aggregate noncash portion totaling $19.6 million of which $14.8 million was a result of stock based compensation expense.

As compared to an aggregate noncash portion of $16 million of which $14.3 million was a result of stock based compensation expense for the same period in the prior year.

As stated in Q2 2019 in accordance with US gap. We have included our revenue recognition methodology, a total of $180 million.

Comprised of $50 million for an anticipated milestones from astrazeneca relating to the filing of the U.S. and da and $130 million in anticipated milestones from a stellar us in connection with the E U M a filings.

When such milestone achievements became probable in.

Included in our third quarter revenue recognition methodology is a $12.5 million milestone associated with the approval for CKD in dialysis patients in Japan.

The timing of when the payments related to these milestones will be remitted to fibrogen depends when the milestones are actually achieved.

As noted earlier on this call our NVCA submission is targeted for Q4 this year and we expect the Astellas M. A submission to occur in the second half of the Astellas 2019 fiscal year, which ends at March 31 2020.

Based on our latest forecast, we estimate or 2019, ending cash to be in the range of $650 million to $660 million.

And this range includes the 50 million dollar U.S., Andy a milestone.

At September 32019.

Average in had $666.5 million in cash restricted time deposits cash equivalents investments and receivables.

Thank you and I would now like to turn to call back over to Jim.

As you have heard we've made significant progress over the past few months looking forward, we'll continue to drive our products programs and organization.

Here are some of our areas of focus.

First barbiturates Board and our search committee has in this year's initiated a search to find a truly exceptional leader to be Fibrogen is permanent CEO .

Well update you as we have more news of our selection.

For Pamrevlumab, we're enrolling our phase three studies for both the IPO for locally advanced pancreatic cancer and we'll focus on opening additional study sites are increasing patient enrollment.

We also look forward to discussions with the FDA to determine the next steps in our Duchenne muscular dystrophy program.

In China, our focus is on securing reimbursement and the upcoming Roxadustat launch we look forward to updating you on that progress in the coming months as well.

For Roxadustat, we're completing our endear submission in conjunction with Astrazeneca and plan to file by the end of this quarter followed by the European M&A submission through our partner Stellus by March of 2020.

As Pat mentioned fiber Jews eligible to receive $180 million in filing milestones from our partners and we are also eligible to receive similar scope approval milestones.

Finally.

We plan to submit the data just presented at the reason for publication and we'll continue to seek out new indications for Roxadustat with our programs in Mds and superior.

At this point I'd like to open up the call for questions.

If you have a question. Please press Star then one I mean touchtone phone.

Or if you were streamed live in the queue. Please press the pound sank where the hash key.

We're using the speaker phone in managed pickup.

The surpassing the numbers.

So again, if you have a question I start anyone has shrunk from.

And your first question it comes from Michael Michael Your line is open.

Thanks, very much appreciate the questions and congrats on the progress.

Although Tom would have been proud of how do you have been there and congressional progress two questions. One is for Piani I would just like to understand since there seems to be some investor concern about FDIC agreements and FDIC Shannon from statistical plans, how Youre general impression was.

Our view on meeting with the FDA and why you feel confident about statistical protocols and they're signing off of what you have some statistics and why you feel good about that my second question is for Gen. In your sheet. Although I. Appreciate your the interim CEO , perhaps you can talk about what your priorities are and what the boards.

Priorities are at this point.

Given where the stock is that where things are I guess, what you're thinking about in terms of priorities from here I appreciate it. Thanks.

Mike. Thank you for the good question first of all I wanted to.

Share at that we happening in that buyer again dialogue with the FDA in the past six years.

And.

And there has been very clear understanding about.

What the phase three requires study would look like.

On site, including the the size of the study how to power it folks and what the primary endpoint and we agree on time you may ask the primary endpoint and that's how we power for than non dialysis and the dialysis and we've also had a very potent.

Tariff dialogue with the FDA on the analysis of a of cardiovascular safety as well as.

Let the efficacy requirement needs to be for this submission.

The most recent conversations with the FDA.

I was happy.

At the end of July .

And tile and we had oh, please send that to the FDA fairly comprehensive briefing package.

And how they have a very productive meeting.

Hi, walking out of it we felt that we had all the guidance from the FDA, we needed to put together a winning submission.

And that is about to be out the door on this quarter.

So you feel no issue or no real concern about the hazard ratios in the upper boundary and all the things that people are talking about you look at diabetes programs and things like that.

You are well within that so you don't feel any concern about that.

No we have no concern about that and Mike as you know pad our regulatory assessment is not a based on one criterium.

But but instead it is based on totality of other than such as efficacy safety, a what is the medical need and so based on our discussions and ER and the historical precedence in this therapeutic area and does.

They have conversations we've had with the agency, we're very comfortable with our data when it is now.

Okay. Thanks, John just for that question for you.

Yeah.

And like I think our I think our focus is very clear as I mentioned through the third my closing remarks are you first and foremost its filing of the India second it's finally through a stellar us the EMEA in Europe .

Behind that is our China and their securing reimbursement along with the support and the our participation in the China launch and what Pamrevlumab, it's around accelerating both the number of sites for the enrollment in our two phase three studies and getting agree with the FDA on where we're taking the DMD program next big beyond that.

Working with the rest of the board, it's finding a very capable person to step in and lead the company longer term.

Okay. Thank you.

Yeah.

Your next question comes from a Checkfree partners. Your line is open.

Thank you. Thank you very much and thanks, everybody for participating in the color just Robert or systems for semi sadness and sympathy about Tom and.

Particularly foreigner given all the recognition progress that you've made with works out of seven per level. Now. So one question I hope you're only if I'm a one chris' question for Chris up Jani could you share.

The number of patients in the non dialysis cohorts the progress dialysis and the difference in timing in the progression of dialysis and perhaps comment.

About whether the patients post progression dialysis, presumably were treated with repo and behaved in the same whereas the incident dialysis patients I'm. So was there a benefit.

From the comparison between Roxa and deeper in the patients who progressed and then Chris could you talk a little bit more about the an ideal listing specifically have you applied for both dialysis and non dialysis and what is the size of the non dialysis patient population, who are anemic enough to justify treatment.

The innovative drugs such as Roxa. Thanks.

Yes.

Yes, you asked a lot of this Ah I notice that the question was more than one [laughter].

So so Keith I think Todd you. This correct to expect battling 40% off the out of the non dialysis patient pool or indeed already had already beach end stage kidney disease, meaning hfive being below 15 than you do expect.

Some patients to a pure required dialysis treatment in this long term outcome program.

And so he being now the analysis of these patients is important because China's fishing, you know that will pick up in finance HR ascension to dialysis.

And we have not had.

Had a chance if you see we have a we have presented a lot of data at the 8% we have not had a chance to two like this one up yet and and we agree with you. This is important that we should present and future medical conferences.

Publications this a little bit complicated.

The two to report that SH culinary yet at over here.

Well.

Uh huh.

I'm sorry.

Was there a benefit at least in time was there a significant difference in the time to progression to dialysis between the two cohorts.

Based on the results from the GTF our change we believe that should be but the data I need to move further analysis as mainly because the time on treatment between walk the things that on placebo tougher.

Okay. Thanks.

Chris I'd love to hear from you about an ideal.

Hi, Jeff. So your first question I believe is whether Roxadustat was invited by the Chinese government NRT out negotiations. So first Joe you're absolutely right. A sponsor is invited you don't proactively apply.

So I think consistent with what Astrazenecas partners have said the two companies are collectively putting a lot of asset in getting into NRG out at this point in time, we're not discussing if there's an invitation primarily because all indications either to roxadustat like other companies are.

You see a confidential and the Chinese government has not published a list of companies invited.

To negotiate so I would prefer to wait until the end of year, Wendy outcomes and Rds is disclose I hope you understand.

With regard to the second question I believe the question was what is the size potential market size of non dialysis. So I had mentioned just now in my section of the script that there are over 600000 dialysis patients in China, 90% to 95% our anemic.

In non dialysis if you look at the CKD population, it's actually 120 million of course, mostly they are early stage and they're not necessarily anemic. If you look at stage three D to about 50% anemic stage for about 70% stage five non dialysis, it's about 90%.

The at those numbers up based on the real World evidence data that we have measurement hemoglobin tenant, although we believe the addressable market in China for non dialysis and limitations, but low hemoglobin eight is close to 2 million patients to substantially population.

And Jeff was very excited because we have an or therapeutic with a safety profile that we think we greatly expanding addressable market.

Great. Thank you very much that Chris.

Your next question culture at a loss your line is open.

Hi, this is either one on call Adam.

For the question first personally before if you only for the individual these components in AG I guess the events for myocardial infarction still.

The data set a small an f. you gave you a focus on the news composite can you. Please further clarify on this ABT amaze dataset.

I.

Yes, so out so I wanted to reiterate that are in our conversation with the FDA.

The primary safety endpoint was the composite mace.

And there was never I mean, we any requirements data it for us to allow for you know for on the individual component a south and saw and I also again remind ourselves side.

Number or size of family MLP number events are fairly small.

On that.

No I another thing to point out is that the lower bound of the 95% contraband involved on each of these individual components are below 1.0.

Which is very different than the other than to stroke a into.

And he and looking at.

The overall picture.

And the overall safety profile of the truck looking at.

Efficacy safety as well as well as so what what how little if on the market for changing the non dialysis patient.

Okay, and my second costs as it.

Oh when are you going to talk to the queries keeping the tops Oh.

Glenn I mean, the statistical analysis plan, including the non inferiority margin. We are there any used creep.

Great and becoming mix.

I am sorry, a about a question or.

Are you asking rubber will publish these resolved we do plan to write up as soon as we can and put it in a scientific journal.

I think Adam I figured. The question is is when we talk to the FDA about the.

Statistics on the analytical plan.

Theres the question right and we plan to talk to them in the coming weeks Oh, Okay. I'm sorry, if the answer to that question is that we had already pump with the FDA about analytical plan and we had agreed made we agreement on the analysis plan [laughter] doubling sounds that we'll have presented in the high impact Clint.

Concession ethane as sand and the numbers I hope that's presented were based on the agreeing a analysis plan that we have made with the FDA.

So the non utility margin of 1.38 already agreement or not.

So we are talking about the analysis plan, meaning how do you pool, you know, what's supporting strategy and the analysis plan how to analyze the data when you talk about Eni margins, a little you're talking about a standard for.

Assessment right and so as I mentioned earlier, Dod we expect that all regulators will assess the data based on a on a very you know all the on the Empire application of the end da.

And based on our dialogue with the FDA over the past six years.

And that data as we have shown.

We are confident that we do half what it takes Ford a far this drug to be favorably evaluate that.

All right, maybe another person fault, great regarding the China market.

Can you help us understand the law self pay a market there.

The housing.

That's really going into the book revenue at a cost.

Right Oh, this 50 business.

Thank you.

[laughter] Edwin with regard to the first question about the self pay market.

So the self pay market is not large and this is why getting intent and RTL. It's an important inflection point for the business to self pay market is.

Basically people not getting reimbursement and choosing to pay 100% out of pocket.

At a price to end and you know it's visible to the market for a roxadustat drug that is higher than the standard of care.

We have sales at this point in time. So there is a self pay market that we do not expect it to be substantially because of that differential in pricing.

With regard to revenue recognition.

Fibrogen is the marketing authorization holder of Roxadustat in China.

Under the two invoices roll it is the manufacturing it's the marketing authorization holder that books revenues. We have a 50 50 profit share with Astrazeneca. So that is how the 50 50 works. It's not a 50 50 split of the topline is a 50 50 split of the profits.

That's very helpful. Thank you.

Welcome.

And your next question comes from Daniel growing up line is open.

Hi, Thanks for taking my question and congratulations on the data I just had a couple of questions. This is neurology on for Danielle by the way.

I was just wondering would you be able to talk a little about whether you're expecting priority review or normal review with the NDS and if you'd be willing to use a priority review voucher.

Okay.

This is a very good question and.

We.

We believe that the basis for a priority review could be because we have a new innovative drug Dod.

It's potentially better than what is available for treating diseases in patients was very serious condition.

However, the decision whether to brand as part of our TV view is that one of the FDIC.

So in Ravi or the second part of your question I would not see us using your priority review, Roger but we we will indeed request priority review.

Okay. Thank you that's helpful.

And I guess my second question would be out would you be able to give us just some color on the Mds study.

Hi, just how its going or how the enrollment is going and when we should expect data and along with you know with other agents are currently in the pipeline for the indication as well how do you see roxadustat sort of fitting in from strategic standpoint.

[noise].

Oh. Good question are we do a we have seen encouraging data from the open label portions of our phase two study, which is I believe we'll be presenting in the upcoming ash and.

I would assume the other age.

So in terms of saw a kind of competitive landscape. We believe that because mds is such a MBS anemia in say condition that there's so much need and so difficult to treat our believes that there are they still opportunity for us to make a difference.

Since in these patients and saw the enrollment is ongoing and we will come back where thing.

And.

You have in the future what timeline on when the study work will be complete.

Yes.

Great. Thank you so much.

Thank you.

And your next question comes from Pouch Lee Your line is open.

[noise], hi, everyone, great to see everyone else.

Yes, and meeting and thanks for taking the question.

My first question is for Penny and.

You did state earlier that that the non dialysis population was not.

Power to individually assessed the various components amazed.

But given the the background of the patient population in terms of their fr level.

Can you give us what is your understanding with regard to the to the FDA position on the on the individual components with respect to when a trial is not powered to show a statistical difference on those individual point given the base patients background population.

And that I had a second our commercial caution on the NRT ill.

So appeal.

We can share our view on the individual components and I'm not that discussion with the FDA a in terms of the requirement for our primary safety endpoints.

On a as I stated earlier as there was never and any explicit expectation on the individual components.

No.

But I you know we do believe thought the evaluations are far but data it has to take into account. The overall our benefit will offer truck for the patient.

So I.

I Hope this answer question.

Oh, yes. Thank you and then on on the NRG Al I know you said it you haven't.

Do you want formerly communicate whether you.

Whether as a set is under invitation to be considered but assuming you assuming it it is under consideration I.

I guess as you think about potential reference pricing pricing on the competitive landscape given the white availability of of Epo and China can you maybe give us what you think of reasonable range is potentially for for pricing on the go forward.

Given the given the availability and pricing repo in China market. Thank you very much.

Absolutely Paul So the way, we think about pricing in China is that follows. So first of all as value based pricing, we evaluate the scope of unmet medical need and the pharmaco economic consequences of not treating are not treating optumthree.

We are not treating safely.

We then compared the clinical efficacy benefits of Roxadustat based on the China Phase three studies over.

He says.

And then we'd love to add the safety advantages over he says.

And this is all about differentiation on clinical basis.

We also with Astrazeneca believe that Roxadustat as a first in class drug.

And a patented first in class struck of course to state the obvious deserves to innovation premium.

Because we are bringing a transformative new treatment paradigm to China.

That above and beyond the clinical benefit to the patient in a quantifiable unmet medical need also supports the country's policy direction of encouraging innovation.

So we're hopeful that roxadustat could become an example.

I've company, bringing innovation to China, and expecting a return for that delivery.

We do not see ourselves being benchmarked against locally manufactured he said because we think we're highly differentiated product with clinical benefits and we believe we deserve an innovation premium.

Obviously, Paul at the end it today, it's about budgetary concerns and budgetary considerations of the Chinese government and affordability for the patient.

So at the end to the day should there be at NRT on negotiations pricing would not just be what we would like to assert the what the country can actually a for it so we'd be eager to see what that balances should there be an energy on negotiation, but that is our pricing strategy in terms of what we believe it's a fair pricing for Roxadustat.

Thanks for taking your questions.

Okay and your next question comes from that show, beating your line is open.

Hi, Joe perhaps your mute on your end.

Sorry about that Okay can you hear me now.

We can drill.

Okay. So the my first question is on the quality of life benefit from the Phase three program.

I believe that there was some initial data presented in the topline data, but then I didn't see anything on quality of life Sun.

Should we still consider cardio life effect to be in line with a topline press release, and how important well quality of life data from the phase three program before marketing the drug.

So is this a quick questions a yes or our data is consistent with what we had up a piece of a reporter and topline.

So we just have so much to put together for the sand and we do look forward to to present the result in self insure conferences and publications.

As you know a one of the manifestations of anemia is for patients inside Petite.

On a loss and quality of life. Thank you.

And then maybe one other question can you talk about the indication you plan to pursue for Roxadustat.

Ah yes so.

So we and our partners believe Saad Roxadustat has the potential to become the ammonia truck for various kinds of Oh saw anemia beyond CKD and so as we have presented we already have ongoing trial in Mds anemia.

And thought in chemotherapy induced anemia.

There are additional anemia pipes that are in considerations such as CEMEA in multiple myeloma patients and a new idea of inflammation.

There has been expensive effort to evaluate all these ah Ah Ah pipes of anemia and more.

Thank you.

Okay in there and your questions at this time.

Well in closing I'd like to thank you for your attention support.

I also want to thank the senior management team and all the dedicated employees with fiber during the U.S. and in China, who are committed to bring novel innovative medicines to patients around the world.

Drilling a version that Tom set for the company 25 years ago.

Thank you.

Yeah.

Thank you ladies and gentlemen. This concludes today's conference. Thank you for participating you may now disconnect.