Q1 2021 FibroGen Inc Earnings Call

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Good day, and welcome and thank you for standing by and welcome to the fiber journey first quarter 2021 and financial results Conference call. At this time all participants are in a listen only mode. After the speaker's presentation, there will be a question and answer session.

Ask the question during the session you will need the press star one on your telephone keypad.

Please be advised the today's conference is being recorded if you require any further assistance. Please press star zero.

I would now like to hand, the conference over to your speaker for today, Mr and Michael Tung. Please go ahead.

Right.

Thank you Erica and good afternoon, everyone and welcome to the fibers in the conference call for fiscal 2021 per store.

And Michael Tang, Vice President of corporate strategy and Investor Relations.

Joining me on today's call are and we can turn it off for Chief Executive Officer.

Dr for CCAR, our Chief Scientific Officer, Pat Cotroneo, our Chief Financial Officer, Dr. Marc <unk>, our Chief Medical Officer.

And our Chief commercial officer.

Chris Chung, our senior Vice President of China operations, Dr. Elliott and sharpening, our senior Vice President of clinical development from safety and Pharmacovigilance.

The format for today's call and Chris' prepared remarks from a rig.

We will open up the call for Q&A.

I'd like to remind you that remarks made on today's call may include forward looking just for ease of apartments current expectation.

The thing we would but are not limited to the statements regarding the collaboration of investors that kind of astellas.

And that's the guidance the initiation of enrollment design conduct and the results of the clinical trials.

Our regulatory strategies and potential regulatory results.

Our research and development activities.

The commercialization and results of operations.

Risks and market opportunity and strategy related to our business.

And the FDA Advisory Committee meeting and other anticipated FDA interactions and certain other business matters and.

Such forward looking statements are subject to significant risks and uncertainties that could cause actual results and events to differ materially from those anticipated in such statements.

For a discussion of these and other material risks and factors that could affect our future financial results of the business. Please refer to the disclosure in today's press release for.

The fiscal 2021 first quarter financial results and business update.

Most recent forms 10-K and 10-Q.

And of course that we may file on form 8-K, with the Securities Exchange Commission.

All statements are made as of today May 10, 2021 based on information currently available to us impact and does not undertake any obligation to update publicly any forward looking statements, whether as a result of new information future events or otherwise except as required by law.

Today's press release reporting our fiscal 2020, one of the first quarter financial results and business update and a webcast of today's conference call can be found on the investors section of fiber to the website at www Biogen Dot com.

With that I would like to turn the call over to Enrique can turn all of our CEO Enrique.

Thank you Mike Good afternoon, everyone and welcome to our first quarter of 2021 earnings call.

Today, I would like to provide a high level summary of the.

Most important and accomplishments and developments in recent months.

But the credit.

But for now our CFO will then review the financials and.

After which we.

We will open up the call for your questions.

The greater range by the assessments the fabric and is uniquely positioned to create significant value for patients that shareholders.

By executing on the three areas of focus of shown on slide two.

Number one.

Ensuring.

The regulatory and commercial success of <unk>.

That's a transformational medicine for the treatment of anemia.

The first in patients with chronic kidney disease.

And difficult potential.

For expansion to the treatment of additional indications.

Number two accelerating the development of the revenue might be three indications with significant unmet medical.

Goodbye and Resectable pancreatic cancer.

<unk> muscular dystrophy and.

Egypt, Inc. Pulmonary fibrosis.

And number three.

The strength and research productivity.

By leveraging our leadership position, Boston hypoxia inducible factor and connected tissue growth factor of biology.

And by accessing external innovation.

Today's call will include a review of Brooks and dispatch.

Our continued strong performance and China.

And the clinical cloud programs.

Let us get started with the Brooks and <unk>.

And as new drug application for our NDA review.

In March.

We announced that the FDA has decided to hold an advisory committee meeting.

For the rocks and the.

Yeah.

Our team remains focused on preparing for the upcoming Advisory Committee meeting would you stand currently scheduled for July and <unk>.

And in April we made an announcement clarify and for the FDA and the medical and the investment communities.

First I'm proud of these clusters of primary cardiovascular safety analysis from the rocks.

The three program for the treatment of anemia of chronic kidney.

Our meeting with the FDA was productive and.

And we have cash further productive discussions with them regarding the yet.

Importantly, this clarification does not impact our overall conclusions regarding the comparability.

With respect to cardiovascular safety of.

<unk>.

The key pointing Alf and dialysis dependent patients and.

And two placebo and <unk>.

Non dialysis dependent patients.

As described on April 6th.

For the east and dialysis subgroup.

Based on the Prespecified stratification factors.

So those studies comparable but not superior to the pointing the offer with regards to cardiovascular safety.

We look forward to publicly discussing the analysis of the cardiovascular safety data and device.

The <unk> Committee and July.

We have reached out to key opinion leaders primary investigators and medical journals and discussed this matter on the discussion thus far have been protected by and I appreciate it.

The progress our internal review expeditiously and we'll communicate at the appropriate time.

Importantly, we are putting controls in place to prevent this type of occurrence and the future.

I want to reiterate the we continue to have confidence and the rocks and just the data on the safety and efficacy profile demonstrated in the phase III program.

<unk> and and Astrazeneca committed to working together with the FDA to bring the.

The patient with the Nimbus and getting in the U S.

Our pre commercial activities have continued.

<unk> recently presented additional analysis of the National Kidney Foundation, the spring clinical meeting and.

And the Ias and World Congress of Nephrology and <unk>.

Continues to be <unk>.

Net interest and got some of those stuff from the clinical community.

Healthcare professional certification of Dvds are ongoing.

Unexpected to increase through the official launch.

And our partner Astrazeneca has a comprehensive renal commercial presence and the U S and <unk>.

And whether we're committed to the Mega this debt available to as many patients as quickly as possible and all.

Order to ensure patient access astrazeneca is leading the discussion without us as realizations and with payers will cover.

For non dialysis patients.

We have submitted the minus scripts covering the CVV anemia phase III study.

<unk> reviewed journals.

As noted in slide three six of these manuscripts have been published encompassing both non independent.

And in data and <unk>.

We expect additional publications of the phase III data and the couple of months.

The Astellas and <unk>.

And the reported their fiscal year, 'twenty, and 'twenty, which ended in the calendar year first quarter.

The guided to total and breath of sales of of <unk>.

Approximately $80 million for the fiscal year 2021.

And this guidance includes the breadth of sales in both Japan and Europe.

And Europe, we continue to expect the midyear of decision by the European Medicines agency and the marketing authorization application for.

For us to do stuff for the treatment of anemia and of those dialysis and non.

Patients with chronic kidney disease.

Moving now to China.

On slide four.

We're pleased to report total rux and <unk> net sales to distributors in China of $43 5 billion for the first quarter.

Versus 29 2 million for the fourth quarter of two.

2020.

The increase in uptick.

They used to be driven by both on the.

For the hospital and these things umbrella of adoption within the list of customers.

And as the revised partnership structure fabric.

Average reported $54 million and China.

Net product revenue for the first quarter of 2021.

We have previously disclosed.

The beginning.

The first quarter join.

Jointly owned distribution and <unk> is responsible for selling roughly.

Distributors and we'll pay for Astrazeneca is of commercialization efforts in China, and ACC portion of the profit share.

Previously.

500 and was responsible for these items.

The JV is expected to account for over 95% of overall sign of Brooks the boost.

Sales volume going forward the rig.

And we'll continue to be conducted the revenue by five years.

Cost per leasing continues to be a key focus of our launch efforts.

At the end of the first quarter adjusted.

Adjusted was listed of hospital of the collectively represent approximately 74% of the CBD market opportunities and China.

As you can see on slide five.

Interestingly the theme it seems the inclusion of Brooklyn this debt.

On the <unk>.

The east Submarkets growth has accelerated.

Fact ease of revenue over the last six months has shown 21% growth of at the same period of the prior year.

Moving to slide six.

Brooks of those staff cuts expanded.

J E mail seeking the category over the past 14 months.

Translates interrupted the adding new patients to.

And so the anemia of <unk> categories.

Combining this view of adjusted uptick along with the growing E category as shown on the previous slide.

Evidence of <unk>.

Most of this debt is growing share and that expanded markets, which is a great sign.

Finally, our share.

And on slide seven.

The study is the number one.

Branded treatment for anemia of CBD in China for each of the per.

Two months.

With a 27% volume share.

And the segment that includes all aesop products and Brooks of dose.

Currently the only safe BHI on the markets.

We continue to see significant drops and just the utilization across a range of anemia of CBD patient populations.

Approximately 65% of patients treated with rux at the site in China Iron dialysis.

Covering hemodialysis and peritoneal dialysis.

And the remaining 35% or none of that.

This broad utilization of butter.

And it's well for long term success and.

Provides critical and earnings as we prepare to launch that this debt.

And the U S Europe and other countries.

We look forward to keeping you updated as we advance our long term goal of making a profit.

Tender of care and creating China the JV.

And <unk>.

Yeah.

Moving now to our clinical development, starting with drops of those debt.

During the quarter.

We completed enrollment of our phase two chemotherapy induced anemia or CIA trial.

And Aspen Denali are too rough to do start the phase III studies of <unk> anemia patients abducted with dialysis organizations.

Many patients half of transition now into the extension phase.

We expect the percent of top line data and the future medical meeting.

Moving now to pump revenue Bob.

In March we announced the initiation of the lattice too.

A phase III randomized double blind placebo controlled trial.

Revenue might be number one is already patients with duchenne muscular dystrophy.

Our bread and <unk> was recently granted.

Fast track designation.

Rare pediatric disease designation from the U S FDA.

For the treatment of the FD.

We value this acknowledgment of the serious and life threatening manifestations of these rare disease.

Our support of our mission to provide by revenue of up as a potential treatment options for DMD patients.

I will turn now the call over to our CFO Pat Cotroneo for.

For the financial updates.

Thank you Enrique as announced today total revenue for the first quarter of 2021 was $38 $4 million as compared to $24 $4 million for the first quarter of 2020.

The current quarter revenue consists of $15 $4 million and.

Net product revenue for <unk> sales in China.

The $14 $6 million and development revenue and $8 $5 million and drug product revenue per rocks reduce debt bulk drug or active pharmaceutical ingredient.

For the same period operating costs and expenses were $108 $9 million and net loss was $71 $8 million for 78 per basic and diluted share as compared to operating cost and expenses of 105 $5 million.

And the net loss of $78 $3 million or <unk> 89 cents per.

Basic and diluted share for the first quarter last year.

Included in the operating costs and expenses for the quarter ended March 31 2021.

It was an aggregate non cash portion totaling $25 1 million of which $19 $4 million was the result of stock based compensation expense as compared to an aggregate non cash portion of $22 $1 million of which 16.

$9 million was the result of stock based compensation expense for the same period in the prior year.

At March 31 fiber can had $682 6 million and cash cash equivalents restricted time deposits investments and receivables.

As mentioned in our last call, we have made some changes and financial reporting.

Starting this quarter the jointly owned distribution entities between the Astra Zeneca and fibre channel or the JD is responsible for selling lots of do start to distributors.

And pays for <unk> commercialization efforts in China, and AZ and portion of the profit share.

Previously fiber Gen was responsible for these items.

As of March 31 of the JD accounted for over 95% of overall, China walks of dues that sales volume.

While the rest continues to be conducted directly by fibre channel.

As such under this new structure of fiber and reported $15 $4 million in China and rocks reduced debt net product revenue for the first quarter of 2021 on the U S GAAP basis.

Which included five regions revenue generated from our sales to the JV as well as our direct sales in China.

To provide context for the operating results of the rocks of juice that business in China.

Total lots of do stat, net sales, including sales through the JV to its distributors and fiber and China is direct sales to our distributors.

Was $43 5 million for the first quarter of 2021.

Looking ahead, and our broader financial picture, we have a total of $245 million and potential milestones expected by the end of the year for anticipated U S and EU approvals and first commercial sale in the U S.

At this point and time, we have no changes and expectations and any of the anticipated milestones between now and year end 2021.

Based on our latest forecast data, we continue to estimate our 2021 and the balance of cash cash equivalents for restricted time deposits and investments and receivables to be and the range of $660 million to $670 million, assuming the U S and EU lots of due status.

And in 2021.

Thank you and then.

I would now like to turn the call back over to Enrique.

And closing this is an exciting time for.

And for fiber channel.

And the second thing.

The perform very well and China.

And you just have the regulatory review and the U S Europe and other geographies.

Our team remains focused on preparing for the upcoming Advisory Committee meeting that is tentatively scheduled for July 15.

We look forward to presenting the <unk> the.

The data and the public Forum.

But Bob is the wholly owned potential first in class of New medicine.

And phase III and developing three indications with significant unmet medical need.

In advance of Resectable pancreatic cancer.

And the muscular dystrophy and video.

For the pulmonary fibrosis.

Finally, we continue to advance our research agenda.

We're delivering on our unique scientific expertise.

Strengthening and broadening our internal capabilities.

Also looking for external opportunities with the goal of expanding our pipeline of innovative drug candidates.

As shown on slide eight and a strong financial position.

The process of sales ramp up.

With approximately $682 million and cash and another 245 million and anticipated rotate those milestone payments expected during the 2021.

I would like to take a moment I would also welcome Patricia Stuart.

And we recently appointed a chief people officer, and the fiber day.

The reporting to me.

She comes to most recently from Genentech.

And we've been responsible for advancing our people and culture strategy.

Looking forward.

And I believe we are positioned for success now.

And now I would like to turn the call back to the operator for questions.

Erica.

Thank you so much for the floor is now open for a question again, if you would like to ask the question you May Press Star one on your telephone keypad, we'll pause for just a moment the compile the Q&A roster.

Our first question comes from the line of Annabel <unk>. Your line is open.

Hi, Thanks for taking my question.

I'm not sure if I missed the.

This will comments, but I was wondering if you could.

Hello, and during the preparation for the AD com.

Conducted analysis of any of the additional clinical benefits that were published and presented her claim Mike reduce RBC transfusion.

Regarding inflammatory start status and the hyper responders of better iron utilization and can you feel.

Unnamed Participant: Don't talk to you. I didn't have a British accent the last time. We're all still dialed in, because I can hear you.

Feel comfortable that the data that you presented at those meetings are accurate and then secondly.

And then from critical learnings and Chi and then maybe you can highlight what the learnings are correct. Thank you.

For.

And good let me.

Turning to the first your first question.

About the.

Russia, those stats and the benefit risk profile to our CMO Chief Medical Officer Mark. Thanks.

Thanks for the question. So yes, so the answer to your question is yes, we have.

Unnamed Participant: We're all still dialed in because I can hear you.

Confirmed the additional benefits in terms of hemoglobin increase from with rock reduced production and Red cell transfusions.

And do start having benefit in patients with high CRP, and who are functionally and iron deficient and so we've been able to confirm all of those results and that has not changed since our April six press release.

Operator: Good day and welcome. Thank you for standing by. This is the Fibergen first quarter 2021 financial results conference call.

Very good.

Operator: At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press PAR 1 on your telephone keypad. Please be advised that today's conference is being recorded. If you require any further assistance, please press Star 0. I don't know. I would now like to hand the conference over to your speaker for today. Mr. Michael Tongue, please go ahead. All right. Thank you, Erica.

Clearly I think when it comes to China I think.

Michael Tung: Thank you, Erica, and good afternoon, everyone. Welcome to the Five Bridges Conference Call for Fiscal 2021 First Quarter. I'm Michael Tongue, Vice President of Corporate Strategy and Investing Relations at Fibirte. Joining me on today's call are Enrique Contenna, our Chief Executive Officer, and Dr. Percy Carter, our Chief Scientific Officer. Ha Kautrenio, our Chief Financial Officer; and Dr. Mark Eisner, our Chief Medical Officer. Thain Weddick, our Chief Commercial Officer

The results seen China, Inc.

Michael Tung: Chris Chong, our Senior Vice President of China Operations, and Dr. Elias Kukshakji, our Senior Vice President of Clinical Development, Drug Safety, and Pharmacivigil. Format for today's call includes prepared remarks from a rigging, after which we will open up the call for Q&A. I'd like to remind you that remarks made on today's call may include forward-looking statements based on private's current expectations

I would call nothing short of.

Michael Tung: Such statements may include, but are not limited to, statements regarding their collaborations with AstraZeneca and Estelleus. Financial Guidance, the initiation, enrollment, design, conduct, and results of clinical trials, our regulatory strategies and potential regulatory results, research and development activities, Commercialization, and results of operations, risks, plans, market opportunity, and strategy related to our business, planned FDA advisory committee meeting and other anticipated FDA interactions and certain other business matters. Such forward-looking statements are subject to significant risks and uncertainty that could cause actual results and events to differ materially from those anticipated in such statements.

Impressive.

And quite frankly and gives us a lot of confidence for <unk>.

So those studies.

The primary choice when it comes to.

Trading on the U S CBD.

Patients.

China across the continuum of both the.

And indeed the.

There are a number of learnings that we are capturing from.

China.

One of them I think I have mentioned in the past was we've seen.

The faster than expected uptick in particular.

And D D.

And yet any of these segments.

And what we basically see is basically also excellent feedback because it is.

Michael Tung: For discussion of these and other material risks and factors that could affect our future financial results, please refer to the disclosure in today's press release reporting our fiscal 2021 first quarter financial results in business update, our most recent forms 10K and 10Q, and the reports that we may file on form 8K with the Securities and Exchange Commission. All our statements are made as of today, May 10, 2021, based on information currently available to us, and Fibrogen does not undertake any obligation to update publicly any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law.

When it comes to our launch clearly.

The first few quarters.

And could be always impressive, but now I think we have a string of quarters, where we've seen continued the growth quarter over quarter. The basically of reflects not just the overall benefit risk profile of the Brooks and <unk>.

And we've discussed.

But also of the feedback from.

Couple of the professionals.

In terms of what you folks of the studies offering the.

The world. So I think it's very honestly, we are very encouraged with the potential read through of debt to other markets.

Michael Tung: Today's press release reporting our fiscal 2021 first quarter financial results and a business update and a webcast of today's conference call can be found on the investor section of Fivergen's website at www5GIN.com. With that, I would like to turn the call over to Enrique and turn off our CEO.

Thank you.

Your next question comes from the line of Michael Your line is open.

Enrique A. Conterno: Thank you, Mike, and good afternoon, everyone, and welcome to our first quarter of 2021 Erniks School. Today, I would like to provide a high-level summary of the most important accomplishments and developments in recent months. Cotrneo, or the CFO, would then review the financials, after which we will open up the call for your questions.

Hi, good afternoon, and thanks for the update.

Two questions. The first was.

And to the extent you can talk about maybe topics relevant areas of interest that you think will be.

<unk> discussed some of our could be a focus for the.

The panel that would be great since it sounded like you've had good ongoing conversations and things maybe you could shed some general light on how to think about that from an expectation standpoint, and the second was related which was that I know that it is being reviewed and in terms of not come from the cardiovascular and renal group is that of separate coup that you've had dialogue with.

Enrique A. Conterno: I reiterate my assessment that Fabergen is uniquely positioned to create significant value for patients and shareholders by executing on the three areas of focus as shown on slide two. Number one, ensuring the regulatory and commercial success of Roxadustat, a transformation of medicine for the treatment of anemia, first in patients with chronic kidney disease, but with significant potential for expansion to the treatment of additional indications. Number two, accelerating the development of Pambreblo mapping three indications with significant and met met.., advanced and resectable pancreatic cancer, muscular dystrophy, and idiopathic pulmonary fibrosis.

How does that play and things in terms of ongoing discussion. Thank you.

Yes.

And have marks either trying to answer.

Both of those questions and I'll complement this appropriate for Mark yes. So thanks for.

Question. So yes, we have been having collaborative dialogue with the FDA about the Advisory Committee I think both of the agency and sorry for Gen <unk> and our partner Astrazeneca want to make sure that we have a very.

Fulsome discussion at the Advisory Committee and the.

Advisory Committee members and the information and need to fully understand the program.

Enrique A. Conterno: And number three, strengthening research productivity by leveraging our leadership position both in hypoxinucible factor and connected tissue growth factor biology and by accessing external innovation. Today's call will include a review of Roxandustra, our continuous strong performance in China, and our clinical crowd program. Let us get started with a Roxadustus new drug application or NDA review. In March, we announced that the FDA had decided to hold an advisory committee meeting for the Roxedustad NDA. Our team remains focused on preparing for the upcoming advisory committee meeting, which is tentatively scheduled for July 15.

Some of the themes I.

I think thats largely characterized it around the benefit risk profile of <unk> for patients with <unk> and EMEA and just further explaining the safety and the efficacy of the medicine for and Edd populations and getting the input, particularly from expert nephrologists, who treat patients.

With <unk> anemia, so thats kind of a broad answer of it that's where we are with the agency at the moment and in terms of you mentioned that this will be of cardio cardio renal drugs Advisory Committee, which it is and yes, we've had conversations both with the office at the office level with the.

And the cardio renal and it's actually yellow channel, but includes cardio renal and also with the benign Hematology division. So we've had discussions at all of those levels of FDA, including the various stakeholders for both of these areas.

Enrique A. Conterno: In April, we made an announcement clarifying for the FDA and the medical and investment communities certain prior disclosures of primary cardiovascular safety analysis from the Roxadustadus phase three program for the treatment of anemia of chronic kidney diseases. Our meeting with the FDA was productive, and we have had further productive discussions with them regarding the outcome. Importantly, this clarification does not impact our overall conclusions regarding the comparable safety of Broxedustia to epitin alpha in dialysis-dependent patients and to placebo and non-dialysis-dependent patients.

And just maybe add debt I think our PREPA.

Preparations when it comes to the article and I think are progressing well.

The reason I ask is because this is supposedly will have renal wanted to follow the expert on there and do you think that that would be of positive yes.

And they would actually be experts on the panel rather than just people who are not familiar with that is that a fair statement.

I think it is important to have nephrology experts with the which I believe the FDA and it tends to have because they do treat patients for <unk> anemia.

And the <unk> setting and dialysis setting so there and a very good position to.

Enrique A. Conterno: As described on April 6th in the Incendiosis subgroup, based on the pre-specified stratification factors, Roxadustar is comparable, but not superior, to inputting alpha with regard to cardiovascular safety. We look forward to publicly discussing the analysis of the cardiovascular safety data at the Advisory Committee in July.

Understand.

<unk> unique attributes of rocks and just out of where the.

And the benefit risk is going to be positive. So yes. So I think it's kind of been really important for.

For all of <unk> input.

Got it thank you.

Your next question comes from the line of Edwin Zhang Your line is open.

Hi, Thanks for taking my question first one can you please remind us the appropriate.

Enrique A. Conterno: We have reached out to key opinion leaders, primary investigators, and medical journals to discuss this matter, and the discussions so far have been productive and appreciated. We continue to progress our internal review expeditiously and will communicate at the appropriate time. Importantly, we are putting controls in place to prevent this type of occurrence in the future.

And design of the App.

And the 90 clinical trials.

All of the new study results going to affect all help the.

And of drops reduce debt and the U S dialysis.

And IV.

And then for.

Sure.

Sure so of the outspend and all of the trials there.

Enrique A. Conterno: I want to reiterate that we continue to have confidence in the Roxadusta data and in the safety and efficacy profile demonstrated in the Phase 3 program. Favrogen and AstraZeneca are committed to working together with the FDA to bring Roxadustra to patients with an EMMOSCD in the U.S., and our pre-commercial activities have continued. Fabergen recently presented additional analysis at the National Kidney Foundation, the Spring Clinical Meeting, and the ISN World Congress of Nephrology, and there continues to be significant interest in Roxadusta from the clinical community. Healthcare professional disease education activities are ongoing, and are expected to increase through the official lodge.

Single arm open label studies conducting conducted and large dialysis organizations and I think we'll provide.

And understanding of rocks did you start and a more real world clinical setting and as of <unk>.

Clinical trial, but it is.

One that is conducted in the setting thats very much of a real world clinical setting for hemodialysis patients we are expecting.

And to present data sometime by the end of the year.

And the scientific meeting and for the large dialysis organizations and the data we are committed to making that available to them.

At the request so they can further understand the value and the use of rocks that you said and your patient populations.

Okay.

Hum.

Enrique A. Conterno: Our partner, AstraZeneca, has a comprehensive renal commercial presence in the US, and together we are committed to making RRofekDDD available to patients as quickly as possible. In order to ensure patient access, AstraZeneca is leading the discussions with dialysis organizations and with payers who cover non-dialysis patients. We have submitted manuscripts covering the KD anemia phase three studies to peer-reviewed journals. As noted in slide three, six of these manuscripts have been published, encompassing both non-dialise independent and dialysis-dependent data, and we expect additional publications of the phase three data in the coming month. Estella recently reported their fiscal year 2020, which ended in the calendar year first quarter. They guided Ebrezzo sales of approximately $80 million for the fiscal year 2021.

On the revenue Matt on DMD or are we going to expect the publication of the phase two study, including the two year data.

And what's your current thinking on the on the market opportunity of <unk>.

Revenue mapping DMD. Thanks.

Yes.

And we'll have mark.

Uncertainty question of our bedroom.

Machine muscular dystrophy.

Questions.

Around the two year data.

Publishing the data.

So we are and the process of.

Working to get the two year.

And it comes data published so I don't have a specific.

Dave for you, yet, but we're working on that actively and.

And we do think that's important show.

The other benefits.

Okay.

Continued the between year one of the near term.

And I think you're asking about the overall of opportunity.

Enrique A. Conterno: And this guidance includes EWrenzo sales in both Japan and Europe. Europe will continue to expect a mid-year decision by the European Medicines Agency on the marketing authorization application for Roxasidusta for the treatment of anemia in adult dialysis and non-diosis patients with chronic kidney disease. Moving now to China on slide 4.

The FD and maybe let me try to frame that in the context of the three programs that we basically have for <unk>.

Revenue per month.

We see each one of these opportunities where there is.

Enrique A. Conterno: We're pleased to report total Roxadusta nail sales to distributors in China of $43.5 million for the first quarter versus $29.2 million in the fourth quarter of 2020. The increase in uptake continues to be driven by both an expansion in hospital listings and broad adoption with enlisted hospitals. Under the revised partnership structure, Fabridge reported $15.4 million in China, Roxandustan, net product revenue for the first quarter of 2021. As we have previously disclosed, beginning in the first quarter, a jointly owned distribution entity, or JDE, is responsible for selling Roxette Duster to distributors and will pay for Astra Seneca's commercialization efforts in China and AIS's portion of the profit share. Previously, Farrogen was responsible for these items. The JDE is expected to account for over 95% of overall China-roxedustad-Selt volume going forward. The rest will continue to be conducted directly by Fiberton.

IPF and ABC or the FDA of significant opportunities.

The IPF opportunity.

When we look at from a from a.

Clearly I think it's important to say that the.

Three of them are significant unmet.

Clinical needs.

The IP of what we're getting in this space.

We expect it to be larger.

The other two legacy than has been the FD.

But each one of those opportunities and significant.

Moving on.

Collectively I think they do represent a message.

Opportunity.

We are we expect the.

The.

And we will have the legacy of results.

The other day results.

And the second half of next year from a retail perspective.

In the case of ICF, we have not sure of that but we expect to share specific type of index for future.

Thank you.

Yeah.

Your next question comes from the line of Jason Berg and your line is open.

Hi, guys. Thanks for taking my questions.

I guess just first on the slew of shareholder suits can you just remind us sort of what's the burden of proof in these matters.

Enrique A. Conterno: Hospital listings continue to be a key focus of our launch efforts. Notably, at the end of the first quarter, Roxadustas was listed in hospitals that collectively represent approximately 74% of the CKD market opportunity in China. As you can see on slide 5.

I would assume the fact that the FDA is moving forward with an AD com inherently implies there is some ambiguity around the safety and the upper bounds of the confidence interval on and Didi, but just kind of curious if you can provide.

Provide a little bit of a helpful legal framework to think about the shareholder class action suits and then my second question is just.

Enrique A. Conterno: Interestingly, since the inclusion of Roxas Dustad on the NRDL, the ESA market growth has accelerated. In fact, ESA revenue over the last six months has shown 21% growth over the same period of the prior year. Moving to slide six, Roxandustad has expanded the anemia of KD category over the past 14 months, which translates into Roxadusta adding new patients to the anemia of KD category. Combining this view of the Dostra Arctic, along with a growing ESA category as shown in the previous slide, it is evident that Roxas Dostat is growing its share in an expanded market, which is a great sign.

On BD, assuming approval, what I wonder about is as the second and third shifts come to market.

What are your thoughts that the dialysis organizations might look to hop from one product and then tapper phase and some of the financial benefits to the second and subsequent third.

Products that may offer some of those financial benefits and just thinking about the the law.

Longevity of the dialysis launch thanks.

Thank you I think on your first question, we do not comment on either ongoing or potential litigation.

That's.

As far as your question about the.

Hips.

How how was the second and third chief whenever the comps in.

Enrique A. Conterno: Finally, as shown on slide seven, Broxedustad is the number one branded treatment for anemia in China for each of the past two months, with a 27% value share in the segment that includes all ESOP products and Broxadustad, currently the only HIF PHI on the market. We continue to see significant Roxandusta utilization across a range of anemia in the KD patient population. Approximately 65% of patients treated with Roxoducet in China are on dialysis, covering hemodialysis and peritoneal dialysis, while the remaining 35% are not on dialysis.

The impact.

And the contracting or.

And so <unk> been able to both from one of the gifts to the other.

A couple of comments that I would make first is clearly.

Launching first is important and we've seen that across.

Many different.

Launches across the first set of bidding classes, because you didnt established yourself and basically the.

Go to broaden the product that the customer proficient and Scott.

Experience with and then second I think quite frankly, there is no real experience in terms of.

Our studies showing basically the switches from what they used to the other and.

Enrique A. Conterno: This broad utilization pattern bodes well for long-term success and provides critical learnings as we prepare to launch Rekhastat in the U.S., Europe, and other countries. We look forward to keeping you updated as we advance our long-term goal of making Roxadoucester the standard of care in treating China's KD andemia patients. Moving now to our clinical development and starting with Druxedostats, during the quarter, we completed enrollment in our phase two chemotherapy-induced anemia, or CIA FAA. In Aspen and Denali, are two Rosedustad Phase 3B studies in KKD anemia patients conducted with US diocesan organizations.

<unk> say the does going to work.

Well keep in mind that our.

And the other day, we have to look at also the.

Clinical data and how does.

The product basically.

And bear overall, so there are a number of variables.

And I don't believe this is the way.

Should we be thinking as we've seen and other.

The.

And the other therapeutic classes.

It's either appropriate or that it will be convenient to just basically switch products large from one compound for a different one for the same class I think there are a lot of considerations that would have the rebate.

Got it thanks.

Yes.

Your next question comes from the line of Geoffrey Porges. Your line is open.

Thank you very much for taking the questions.

The first one off of.

Couple of it you, probably counterword enhancer and and one with hopefully you can.

The first is.

Pat Cotrneo: Many patients have transitioned now into the extension phase, and we expect to present top-land data at a future medical meeting. Moving now to Pambremvlobap, in March, we announced the initiation of Le Lantus II, a phase three randomized double-blind placebo-controlled trial of Pambrelomab in ambulatory patients with shin muscular dystrophy. Pambremblumat was recently granted fast-track designation and rare pediatric disease designation from the US FDA for the treatment of dmV. We value this acknowledgement of the serious and life-threatening manifestations of this rare disease and support of our mission to provide Pambrevlovab as a potential treatment option for DMD patients. I will now turn the call over to our CFO, Pat Cotrneo, for the financial application. But

And of the discussions with the FDA.

Can you give us a sense of where the the basis for the labeling discussions is going to be the per protocol.

The stratification of the <unk>.

Post hoc stratification.

That would be helpful and then secondly.

And you have these phase II phase III studies, and CIA and Mds coming.

And the second half of the year and the beginning of next year and then obviously those indications are completely different price points to the dialysis and non dialysis and indications where of course, you have to think about the <unk>.

And right and all of that sort of thing so.

Have you had any further thoughts and we carry about whether you will price differentially to the different markets and whether that is feasible.

And whether we should expect you to price pretty much and the same band and.

Pat Cotrneo: Thank you, Enrique. As announced today, total revenue for the first quarter of 2021 was $38.4 million, as compared to $24.4 million for the first quarter of 2020. The current quarter revenue consists of $15.4 million in net product revenue for RoxaduStat sales in China, $14.6 million in development revenue, and $8.5 million in drug product revenue for rachshadustad bulk drug or active pharmaceutical ingredients. For the same period, operating costs and expenses were $108.9 million, and net loss was $71.8 million, or 78 cents per basic and diluted share, as compared to operating costs and expenses of $105.5 million, and an Internet loss of $78.3 million, or 89 cents per basic and diluted share for the first quarter last year.

And then lastly for China.

Pat Cotrneo: Included in operating costs and expenses for the quarter-ended March 31, 2021, was an aggregate non-cash portion totaling $25.1 million, of which $19.4 million was a result of stock-based compensation expense as compared to an aggregate non-cash portion of $22.1 million, of which $16.9 million was a result of stock-based compensation expense for the same period in the prior year.

Is the reported revenue the number of new arrangement that the.

It comes into your results as the proportion of the total revenue and market is that percentage likely to remain relatively constant going forward or actually increase or is it just kind of be really bouncy.

Yes.

Thank you Jeff for.

Your questions.

The first phase of when it comes to our interaction with the FDA I think and we're not really for.

<unk> any detail when it comes to.

Our.

And the interactions clearly.

Just in general I think the.

We expect that the FDA would be looking at the overall.

Evidence of what we.

Including what the prime money, where the primary analysis and.

Also a number of sensitivities around some of those.

Analysis.

So so far we feel good about our discussions with the FDA in the day.

Our very productive discussions.

In terms of your question around CIA MBS clearly when it comes to Mds I think that's where the biggest price differential.

And is.

It's also in.

CIA but of course women of the need to see when you couple of the CIA what's the base of the phases of results.

And what is the dose and.

So far and what also.

What is the we're basically seeing so I expect the CIA what there might be some.

Pat Cotrneo: As mentioned in our last call, we have made some changes in financial reporting. Starting this quarter, the jointly owned distribution entity between AstraZeneca and Fibrogen, or the JDE, is responsible for selling Roxadustat to distributors and pays for AZ's commercialization efforts in China, an AZ portion of the profit share. Previously, Fibrogen was responsible for these items.

Yes.

The slightly different price points I don't view of the months.

And so many decades of and there is a pretty <unk>.

The significant difference between.

Pat Cotrneo: As of March 31, the JDE accounted for over 95% of overall China Roxadustat sales volume, while the rest continues to be conducted directly by fiber. As such, under this new structure, Fibrogen reported $15.4 million in China in net product revenue for the first quarter of 2021 on the U.S. Gap Base, which included Fibergen's revenue generated from our sales to the JDE, as well as our direct sales in China. To provide context for the operating results of a Roxadustad business in China, Total Rocks Addustat net sales, including sales through the JDE to its distributors and Fibrogen China's direct sales to our distributors, were $43.5 million for the first quarter of 2021.

Products and.

And the markets.

Used for Mds and beta.

Basically what we want the price for example.

E Mail JV with Brooks of those debt.

I think it's fair that we went and make sure. The we are appropriately pricing. So the we've got based on the value that the products of the medicine and he is offering and.

And the different populations and.

And while that is always the goal.

And we all know that that is the challenge in particular.

And.

Is the challenge in the U S.

How to talk to effectively do that so.

And just putting debt, we're not commenting on.

And how we are.

Thinking about that but clearly the test will be part of our strategic thinking and just to ensure that we are appropriately.

We received and the value for of what Rob said this debt offering the different patient populations.

Finally, you asked a question about.

The relative.

Coverage of reported revenue of relative to the deal with the overall sales for the submit net sales.

<unk> between the joint distribution entity of <unk>.

<unk> and direct sales and whether that proportion that we reported this quarter.

The the.

Ongoing for.

Bush of going forward there are a number of factors that play into this.

Pat Cotrneo: Looking ahead at our broader financial picture, we have a total of $245 million in potential milestones expected by the end of the year for anticipated U.S. and EU approvals and first commercial sale in the U.S. At this point in time, we have no changes or expectations in any of the anticipated milestones between now and year end 2021. Based on our latest forecast data, we continue to estimate our 2021 ending balance of cash, cash equivalents, restricted time deposits, investments, and receivables to be in the range of $660 to $670 million, assuming the U.S. and EU reduce that approval in 2021.

We provided some guidance I think during the last.

Earnings call that we expected that number will be somewhere between 30 and.

And 45%.

We need to.

We continue with that type of guidance. So I think it's been a bounce of legal fees based on.

A number of different.

The considerations.

I think the bottom line here is when we look at the overall net sales of process.

The two distributes to consumers it is pretty clear I think that the.

The product.

Incredible performance of your trading volume I think.

In terms of what he's offering patients.

And that China.

Pat Cotrneo: Thank you. And I would now like to turn the call back over to Enrique. In closing, this is an exciting time. For five years, Roxette Duster continues to perform very well in China and is under regulatory review in the US, Europe, and other joggers.

Great, Thanks, very much and region.

The next question comes from the line of Yaron Werber. Your line is open.

Hi, Thank you very much for taking the questions guys. This is brendan on for the run just a couple of quick ones from US I think first looking at the growth of of Rockies debt sales in China.

Enrique A. Conterno: Our team remains focused on preparing for the upcoming Advisory Committee meeting that is tentatively scheduled for July 15, and we look forward to presenting the Roxas Dusted Data in a public forum. Pambrelomab is a wholly-owned potential first-in-class new medicine in phase three developing three indications with significant unmetical need, locally advanced and respectable pancreatic cancer, machine muscular dystrophy, and idi Finally, we continue to advance our research agenda. We're delivering on our unique scientific expertise, strengthening and broadening our internal capabilities, while also looking for external opportunities with a goal of expanding our pipeline of innovative drug candidates. As shown on slide 8, we're in a strong financial position for the Roxandusta sales ramp-up, with approximately $682 million in cash and another $245 million in anticipated Roxasdusta moustone payments expected during 2020.

And it looks like January and February sales or maybe more of less flattish are there. Some specific drivers behind that that you can maybe identify and help us understand.

And so some of the commercial dynamics at play there.

And then secondly, just on the Denali and asking the study I think you mentioned just now.

We could get data from there and maybe by the end of this year.

And if memory serves me I think you were supposed to see that data and Q1 of the tier originally so I guess have there been any delays the enrollment of our treatment there that you might be able to comment on thanks very much.

Yes.

Okay. Let me try to address your question about China, and I think of you mentioned that the.

And the sales in China, and maybe where if I understood correctly and you felt they were flattish.

January and February I don't think Thats the case.

For the stub period.

<unk>.

Do you see and increase share and we're seeing increased share and.

And the growing markets right. So.

And we feel very good about.

Where we are and when we look at our internal sales in the first quarter of beauty.

Or the sales that were reported just.

Enrique A. Conterno: I would like to take a moment and also welcome Tricia Stewart, who we recently appointed as Chief People Officer at Fiverton, reporting to me. She comes most recently from Genentech and will be responsible for advancing our people and culture strategy. Looking forward, I believe we're positioned for success. Now, I would like to turn the call back to the operator for questions. Erica?

And just right now and its overall net sales.

And I think we've seen a significant increase.

And.

North of 40% sequentially between Q4.

For 2020, and Q1 of 2021 so.

I don't believe that's the.

And that's the.

Thanks.

And your second question was related to the valley.

Operator: Thank you so much. The floor is now open for questions. Again, if you would like to ask a question, you may press star 1 on your telephone e-pad. We'll pause for just a moment to compile the Q&A list. Our first question comes from the line of Annabelle Zanini. Your line is open.

And I spend the number and I have mark is there.

Prevent and answer yes, I think that there is two different things one is one for me and sets us and open label study.

The possible to provide for dialysis organizations data cuts for their own use debt was.

Starting Q1 and possible.

What I was talking about as the distinctive factor was when we expect topline data from the overall study to be available and that.

Annabel Eva Samimy: Hi, thanks for taking my question. I'm not sure if I missed the initial comments, but I was wondering if you could tell us, during the preparations for the adcom, have you conducted analysis of any of the additional clinical benefits that were published or presented or claimed, like reduced RBC transfusion, efficacy regarding inflammatory status and hypers, or better iron utilization? And can you feel comfortable that the data that you presented at those meetings are accurate? And then, secondly, you mentioned some critical learnings in China. Maybe you can highlight what those learnings are for us. Thank you.

We've been consistent should be by the end of year and medical meeting.

Sure.

Alright, thanks very much growth.

Your next question comes from the line of BC Yang Your line is open.

Hi, good afternoon, and thanks for taking my question and.

Just two questions so coming back to the Denali and the Aspen.

Wow.

Would you be able to clarify it.

The the size of the clinical sites are mostly davita or fresenius or it's the balance of the two.

Mark Eisner: Very good. Let me turn your first question about Roxadustadt and the benefit risk profile to our CMO, General Officer Mark Eister. Yeah, thanks for the question. So, yes, the answer to your question is yes. We have confirmed the additional benefits in terms of hemoglobin increase with Roxas, reduction and red cell transfusions, roxydustead having benefit in patients with high CRP and who are functionally iron deficient. So we've been able to confirm all of those results, and that has not changed since our April 6th press release. Very good

And the second question and he is related to AD com.

What's the role for Astrazeneca for this.

And is it primarily driven by fiber channel.

Thank you.

Yes, let me.

Just very quickly on.

And the Valeant ASP and we're not commenting on.

What are we doing those studies with but we said clearly we're doing these large studies.

Patients.

And as far as the outcome of course of coverage and is the sponsor.

So one of the where the where the sponsor of the NDA and maybe Mark and you can provide some.

Enrique A. Conterno: Clearly, I think, when it comes to China, I think the results in China are, I think, I will call nothing short of impressive, and quite frankly, gives us a lot of confidence about how Roxand Dostan is becoming a primary choice when it comes to treating immune-CKD in patients in China. across the continuum of both. They'd be, There are a number of learnings that we are capturing from China. One of them I think I've mentioned in the past was we've seen a faster than expected update, in particular in the NDD segment.

Additional comments of the role of Astrazeneca.

I would describe it as a highly collaborative effort between fiber and Astrazeneca.

Essentially for him to join <unk> team.

And two.

Prepare for the Advisory committee to prepare the periphery of presentations and get ready for the Q&A. So it's a highly collaborative process between both companies.

Thank you.

Yes.

Your next question comes from the line of Paul Choi Your line is open.

Hi, This is the Liza on for Paul Thanks for taking the question a quick one from US now that Pam wrap the Mab has fast track and rare pediatric disease designation for DMD program can you walk us through how you're thinking about any updated timing and this program regulatory and potentially commercial and thank you.

Yes, and maybe I was.

Enrique A. Conterno: And what we basically see is basically also excellent feedback because when it comes to a launch, clearly, the first few quarters could be always impressive, but now I think we have a string of quarters where we've seen continuous growth quarter after quarter that basically reflects not just the overall benefit risk profile or risk that we've discussed but also the feedback from health professionals and patients in terms of what Roxas is offering in the real world. So I think it's very, honestly; we are very encouraged by that and the potential re-transmission of that to other markets.

The comment on.

Uh huh.

I'll make some initial comments from mark.

And at some of the sort of color Peter and I think the the.

Key for us when it comes to.

And ensuring that we've got.

And complete our DMD and be able to bring this medicine to.

To patients is really the enrolment of the trial. So we are working very closely to diligently to try to ensure that the enrollment and BMD for.

Both of our trials can happen.

As quickly as possible so that and we've added the number of additional sites, including now in China.

And where we got the the.

Approval and we've started the basically recruiting patients.

Michael Jonathan Yee: Your next question comes from the line of Michael Yee. Your line is open.

As well the treatment of the overall.

Michael Jonathan Yee: Hi, good afternoon, and thanks for the update. We had two questions. The first was to the extent that you can talk about maybe topics or relevant areas of interest that you think will be discussed.

A global program so.

We are excited about those designations I think does the submission generally basically allow for.

Basically more interaction.

And with the FDA and just particular cases in relation of this program and I.

Michael Jonathan Yee: or could be a focus for the panel, that would be great, since it sounded like you've had good ongoing conversations and things. Maybe you could shed some general light on how to think about that from an expectation standpoint. And the second was related, which was that I know that it is being reviewed in terms of

I think thats the benefit from a regulatory review process.

Got it and provide.

<unk> provides the basis to be able to move quickly more quickly on the result.

Michael Jonathan Yee: in terms of an advisory committee from the cardiovascular renal group. Is that a separate group that you've had dialogue with, or how does that play into things in terms of ongoing discussions? Thank you. Yes, I'm going to have Mark Eisner try to answer both of those questions and I'll compliment us appropriately, Mark. Yeah, so thanks for the question.

Any type of issues and the probe miner Mark.

And additional comment so I think that was well stated and retail and the I would say the both the fast track and the pediatric rare disease designation from FDA and speak to the high unmet medical need and the potential for Perm.

Rob will now too to help patients.

And with better outcomes.

With this high unmet medical need and I think it helps us in terms of enrolling the trial, because it's just and.

Mark Eisner: So, yes, we have been having collaborative dialogue with the FDA about the advisory committee. I think both the agency and Fibrogen and our partner, AstraZeneca, want to make sure that we have a very fullsome discussion at the advisory committee and give the advisory committee members the information. they need to fully understand the program. In terms of the themes, I think I'd largely characterize it around the benefit-risk profile of Roxidustadt for patients with KD anemia and just further explaining the safety and the efficacy of the medicine for NDD and DD populations and getting input, particularly from expert nephrologists who treat patients with KD anemia.

Other way of highlighting how important <unk> studies are so overall I think it's.

It's a real positive for our ability to enroll these trials and to focus on doing it expeditiously.

Yeah.

Great.

Thank you. The next question we have is from the line of NBC. Your line is open.

Oh, great. Thanks for taking my question.

I have two questions regarding the China market dynamics, maybe for.

For a quick.

So the trajectory in terms of the hospital.

Very impressive.

So I'm just curious as you kind of reach.

Mark Eisner: So that's kind of a broad answer, but that's where we are. We are with the agency at the moment. And in terms of, you mentioned that this would be a cardiorenal drug advisory committee, which it is, and yes, we've had conversations both with the office at the office level with the cardiorenal, it's actually O-Chine, but it includes cardiomean, and also with the benign hematology division. So we've had discussions at all those levels of FDA, including the various stakeholders for both disease areas.

Going from about 74 to <unk>.

And the high 90 per se.

And what are some drivers.

Your team and thinking about in terms of continuing to grow that revenue line.

And also in terms of the kind of the periodicity of the national reimbursement.

Dan.

And I think every single year, there is kind of scheduled pricing cuts mandated by the government I'm just wondering.

Mark Eisner: I will just maybe add that I think our preparations when it comes to the outcome are progressing. The reason I ask is because this is, supposedly, we'll have renal or nephrology experts on there, and you think that would be a positive, yes, because there would actually be experts on the panel rather than just...

And what the fiber and China team and thinking about.

In terms of the kind of preparing for that thank you.

I think I'll have Chris and data address both of the questions. When it comes to drivers for revenue growth going forward.

China's we.

And to.

And have increased.

Unnamed Participant: For people who are not familiar with that, is that a fair statement? I think it is important.

And as a limit.

Unnamed Participant: I think it is important to have nephrology experts, which I believe the FDA tends to have because they treat patients who see KD anemia both in the NDD setting and in the dialysis setting. So they're in a very good position to understand the unique attributes of oxygstadum where the benefit risk is going to be positive. So yes, I think it's going to be really important to have that nephrology

And how well we've done the customer listings.

In terms of of how much was the continued to contribute.

And then also I think humana.

Question about the and RVO and.

And I would say the negotiation for prototyping and so two years not every year. Although there is every year. There is some brunt of the need to be.

Negotiate and Chris.

Sure So to answer the first question for you.

Think of hospital listings and market access.

And the hospital formulary position.

Edwin-Jung: Your next question comes from the line of Edwin-Jung. Your line is open.

So once you get your first and the door and case roster of niche that you still need to confirm the prescribers and one at this time.

Edwin-Jung: Thank you. Thank you for taking my question.

Mark Eisner: First one, can you please remind us the purpose and design of the Aston and Denali clinical trials? How are the new study results going to affect or help the adoption of Robsodewstet in the US Dialysis Organization? And then I have a follow-up question.

So that's the 35 nephrologists and the departments and you don't get all sorts of five and the first day you might get five the.

You might get 10, and hopefully this upward trajectory.

And for every single prescribed but let's say they have 200 patients and can you also don't get the 200 and on the first day you might get 20, and then you might get 25% you might get.

Mark Eisner: Sure, so the Aspen Denali trials are single-arm open-label studies conducted in large dialysis organizations that I think will provide an understanding of Roxodustat in a more real-world clinical setting. It is a clinical trial, but it is one that's conducted in a setting that's very much a real-world clinical setting for haemodialysis patients. We are expecting to present data sometime by the end of the year, you know, at a scientific meeting. And for the all-large dialysis organizations, I mean, the data, we are committed to making that available to them at their request so they can further understand the value and the use of Roxasidustad in their patient population.

Obviously, if we were successful and would love to get the vast majority of the prescribers and the vast majority of the FRP.

And they're so far to the extra cash.

True.

So we see getting upfront of the door in terms of the success, we have in hospitals and <unk>.

Bulk very very well for future.

The option.

We're at the very very beginning of market adoption of rock.

So 74% very good which means that 74% of the potential market.

And actually get access to prescription, but that doesn't mean that that's the end.

I hope that makes sense.

The second question with regards to and RTL and we cant absolutely correct and it's renewed every single year.

The rocks.

Mark Eisner: Okay, my next question on Pam Ravumab for DMD, are we going to expect a publication of the phase two study, including the two-year data? And what's your current thinking on the market opportunity for Pam Ravumab in D?

The price negotiations in Q4 of 2021, and the new price will become effective and too.

The 22.

There are obviously a number of factors that they would consider and the price first if the budget the impact of Braskem from Scott on the National Health care budget.

Edwin-Jung: E&D. Thanks.

And the value proposition of <unk>.

Edwin-Jung: We'll have Mark answer questions on pulverillumab and machine muscular dystrophy and questions in particular around the two-year data on publishing the data. Right, so we are in the process of working to get the two-year outcomes data published, so I don't have a specific date for you, but we're working on that actively. And we do think it's important to show, you know, how the benefits continued between year one and year two.

And how much we actually Dave and healthcare costs and.

Any other factors and the value proposition and third is really how strong is the market adoption of how much of the prescribers valid described.

And we remain confident in the outcome of price negotiations to be clear and the price.

And one way all of which goes down and never goes up.

And just discretion of.

And RTL in terms of how the valuation and how much comes down.

Every single year, they've come up with the defense.

The criteria for determining pricing for 2019, one was different from 2020, the 2021 eligibility criteria and prioritization has not yet been announced.

Mark Eisner: And I think you're asking about the overall opportunity in DMD, and maybe I can try to frame that in the context of the three programs that we basically have for Pam Prelima. We see each one of these opportunities, whether it's IPF, LAPC, or DMD, as significant opportunities. The IPF opportunity, when we look at it from a clearly, I think it is important to say that the three of them are significant and meet clinical needs.

Very closely with market access and Astrazeneca and demonstrate the value of our drug and remain confident of Barrick.

The outcome for Q4 for sure.

<unk> for the.

That will be effective for two years thereafter.

Hey, Chris. This is this is the sustained if I could just maybe piggyback on to your answer on the China trajectory to answer.

And some more color on the Andes first question and this is really the first time, we've provided some granularity around China performance over and above revenue and the snapshot of.

The hospital listings and things of that nature, and so if you take a look at some of the slides that we provided for the first thing to reiterate and we've got a market. When you add the use of growth on top of the the category expanding nature of rocks and do you said, it's a market, that's really taken off which which really highlights the promotional responsive.

Mark Eisner: The IPF opportunities are expected to be larger than the other two, LAPC then and then DMD. But each one of those opportunities is significant on its own. And collectively, I think they do represent a massive opportunity. We expect that we will have the LAPC results and DMD results in the second half of next year from a read-up perspective, while in the case of IPF, we have not shared that, but we expect to share it at a specific time in the near future.

To this category and then when you take a look at the market share perspective, we provided which is a value based market share of 27% were and the process of turning that value based market share and two of volume based share calculation, which is a bit difficult given.

Some of the dosing dynamics associated with the pieces, but it's probably fair to say that our current volume penetration is much much lower than 27%, which just speaks to the significant upside potential. The rocks of these debt continues to have and the China market and we think it's also as Enrique said in his prepared comments, it's a really nice read through.

Jason Matthew Gerberry: Your next question comes from the line of Pace and Gerberry. Your line is open.

Jason Matthew Gerberry: Oh, hey, guys. Thanks for taking my questions. I guess just first, on the slew of shareholder suits, can you just remind us sort of what the burden of proof is in these matters? I would assume the fact that the FDA is moving forward with an adcom inherently implies there's some ambiguity around the safety and the upper bounds of the competence interval on NDD. But just kind of curious if you could just provide a little bit of a helpful legal framework to think about the shareholder class action suit.

To the other markets, where and when we are able to launch and the U S and Europe.

As there are no further questions at this time I would like to turn the call back to Enrique. Please go ahead Sir.

Thank you Erica.

Very much appreciate everyone's participation of today's investor call and jury series.

For the fiber day.

Jason Matthew Gerberry: And then my second question is just on DD; assuming approval, what I wonder about is as the second and third hiffs come to market, what are your thoughts that these dialysis organizations might look to hop from one product ending its DAPA phase and some of the financial benefits to the second and subsequent third products that may offer some of those financial benefits? Just thinking about the longevity of a dialysis launch, thank you. Thank you.

Please follow up with our Investor Relations team. If you have any questions. We have that address some of the call and enjoy the rest of your day. Thank you very much.

This concludes today's conference call. Thank you all for joining you may now disconnect.

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Enrique A. Conterno: I think on your first question, we do not comment on either ongoing or potential litigation. As far as your question about hips and, you know, how would the second or third if, whenever it comes, impact the contracting or maybe an analysis organization being able to move from one hif to the other. A couple of comments that I would make.

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Enrique A. Conterno: First, clearly, launching first is important, and we've seen that across many different launches across different sort of period classes because you tend to establish yourself as basically the go-to product, the product that healthcare professionals have experience with. And then second, I think quite frankly, there's no real experience, you know, in terms of our studies showing basically switches from one to the other, and who can say that that's going to work?

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Enrique A. Conterno: Keep in mind that the other day we also have to look at the clinical data and how the products basically compare overall. So there are a number of variables, and I don't believe this is that we should be thinking, as we've seen in other therapeutic classes, that it's either appropriate or that it would be convenient to just basically switch products.

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Michael Jonathan Yee: Your next question comes from the line of Jeffrey Porges. Your line is open.

Michael Jonathan Yee: Thank you very much for taking the questions. First one, I'll ask a couple that you probably already know the answer to, and then one that, hopefully, you can.

Michael Jonathan Yee: In the discussions with the FDA, can you give us a sense of whether the basis for the labeling discussions is going to be the per protocol stratification or the post-talk stratification? That would be helpful.

Michael Jonathan Yee: And then secondly, you have these phase two and phase three studies in CIA and MDS coming in the second half of the year and the beginning of next year, and then obviously, those indications are at a completely different price point from the dialysis and non-dialysis indications where, of course, you have to think about the bundled rate and all that sort of things. So have you had any further thoughts, Enrique, about whether you will price differentially for the different markets and whether that's feasible?

In terms of income.

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Michael Jonathan Yee: or whether we should expect you to price pretty much in the same band. And then lastly, for China, is the reported revenue under the new arrangement that comes into your results as a proportion of the total revenue in the market likely to remain relatively constant going forward or actually increase, or is it just going to be really bouncy, thanks? Yeah, thank you, Jeff, for your questions.

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Enrique A. Conterno: Let me first state that when it comes to our interaction with the FDA, I think we're not really providing any detail when it comes to our interactions. Clearly, just in general, I think the FDA will be looking at the overall evidence, what we include, what the primary analysis is, and also a number of sensitivities around some of those analyses. So far, we feel good about our discussions with the FDA in that they are very productive discussions.

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Enrique A. Conterno: In terms of your question around CIA and MDS, clearly, when it comes to MDS, I think that's where the biggest price differential is. It's also in CIA, but, of course, we're going to need to see when it comes to CIA what it is based on the phase two results. What is the dose, and so forth.

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Enrique A. Conterno: And also, what is it that we're basically seeing? So I expect the CIA, well, there might be some slightly different price points. But I don't view them as meaningful.

Enrique A. Conterno: In the case of MDS, there is a pretty significant difference between products and the markets that have been used for MDS and basically where we would price, for example, an email CKD with Roxa Dost. I think it's fair. that we want to make sure that we are appropriately pricing so that we can, based on the value that the product, the medicine, is offering in the different populations. And while that is always the goal, as we all know, that is a challenge, particularly in the U.S., on how to effectively do that.

The question.

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Enrique A. Conterno: So at this point in time, we're not commenting on how we are thinking about that, but clearly that has to be part of our strategic thinking, just to ensure that we are appropriately receiving the value for what Roxatoste is offering the different patient populations. Finally, you ask a question about the relative, fabric, and reported revenue relative to the overall sales to distribute between the joint distribution entity and the manufacturer's indirect cells.

Enrique A. Conterno: And with that proportion that we reported this quarter, that is going to be the ongoing proportion going forward. There are a number of factors that play into this. We provided some guidance, I think, during the last earnings call that we expected that number would be somewhere between 30 and 45%. We need to continue with that type of guidance. So I think it's going to bounce a little bit based on a number of different considerations.

Enrique A. Conterno: I think the bottom line here is when we look at the overall net sales of Roxandustat to distributors, it is pretty clear, I think, that the product is having incredible performance and it's really valued, I think, in terms of what it offers patients in China. Great, thanks very much.

Aaron Werber: The next question comes from the line of Aaron Werber. Your line is open.

Brendan O'Connor: Hi, thanks very much for taking the questions, guys. This is Brendan Amprey Run. Just a couple quick ones from us. You know, first, looking at the growth of Rocksuset sales in China, it kind of looks like January and February sales are maybe more or less flattish. Are there some specific drivers behind that that you can maybe identify to help us understand?

Brendan O'Connor: and just some of the commercial dynamics that play there. And then, secondly, on the Denali and Asking study,

Brendan O'Connor: Secondly, just on the Denali and Aspen studies, I think you mentioned just now that we could get data from there maybe by the end of this year. You know, if memory serves me, I think we were supposed to see that data in Q1 of this year originally. So I guess have there been any delays in enrollment or treatment there that you might be able to comment on? Thanks very much.

Mark Eisner: Yeah. Um... Okay, let me try to address your question about China, and I think you mentioned that the sales in China maybe were, if I understood correctly, you felt they were flattish in January and February. I don't think that's the case for Roxette Luset, though. We're basically seeing increased share, and we're seeing increased share in a growing market, right? So we feel very good about where we're seeing increased share. and when we look at our internal cells in the first quarter clearly, and or the cells that we reported just right now when it's overall net cells to distribute them.

Mark Eisner: I think we've seen a significant increase, north of 40% sequentially between Q4 and 2020 and Q1 of 2021. So I don't believe that the case and your second question were related to Denali and Aspen, and I'm gonna have Mark Eisner provide an answer. Yeah, I think that there are two different things. One is when, I mean, since it's an open and able study, it is potentially possible to provide the LARC dialysis organizations with data cuts for their own use.

Mark Eisner: So that was starting Q1. What I was talking about as a distinctive factor was when we expect, you know, top line data from the overall study to be available. And that, I think we've been consistent that that should be by end of year at a medical meeting. All right, thanks very much, guys.

B. Sayyang: Your next question comes from the line of B. Sayyang, your line is open. Hi, good.

B. Sayyang: Hi, good afternoon, and thanks for taking my question. Just two questions, circling back to the Denali at Aspen trials, would you be able to clarify if the sites, the clinical sites, are mostly Vita or Fresenius, or it's a balance of the two? And the second question is related to Com. So what's the role for AstraZeneca in this outcome, is it primarily driven by fiber?

Enrique A. Conterno: Yeah, let me, just very quickly on Denali and Aspen, we're not commenting on who we are doing those studies with, but as we said, it's clearly we're doing this with large research organizations. And as far as the outcome, of course, Fabergin is the sponsor.

B. Sayyang: Yeah, let me, uh,

Mark Eisner: So we're the sponsor of the NDA, and maybe Mark, you can provide some additional comments on the role of AstraZeneca. Yeah, I would describe it as a highly collaborative effort between Fibrogen and AstraZeneca. You know, we've essentially formed a joint working team to prepare for the advisory committee, to prepare the presentation, and to get ready for the Q&A. So it's a highly collaborative process between both companies.

Paul Choi: Your next question comes from the line of Paul Choi. Your line is open.

Paul Choi: Hi, this is the Lee-on for Paul. Thanks for taking the question. A quick one from us: now that Pamrablumab has fast track and rare pediatric disease designation for its DMD program, can you walk us through how you're thinking about any updating timing in this program, regulatory, and potentially commercial as well? Thank you. Yeah, maybe.

Enrique A. Conterno: Yeah, maybe I will comment on I'll make some initial comments, and Mark will add some additional color. Clear, I think the key for us when it comes to ensuring that we can complete our DMD and be able to bring this medicine to patients is really the enrollment in our trial. So we are working very closely with, and diligently to try to ensure that involvement in the MD for both of our trials can happen as quickly as possible.

Enrique A. Conterno: To that end, we've added a number of additional sites, including now in China, where we have gotten the approval, and we've started basically recruiting patients in DMP as well, which will contribute to the overall global program.

Enrique A. Conterno: So we are excited about those designations. I think the designations generally basically allow for more interaction with the FDA in this particular case as related to this program. And I think that's a benefit from a regulatory review process and can provide the basis to be able to move quickly or quickly and resolve any type of issues in a problem manner. Mark, any additional comments? I think that was well stated, Enrique.

Mark Eisner: I mean, I would say that both the fast track and the pediatric wear disease designation from FDA speak to the high level of medical need and the potential of Pamrevel map to help patients, you know, with better outcomes, with this high level of medical need. And I think it helps us in terms of enrolling the trial because it's just another way of highlighting how important these studies are. So overall, I think it's a real positive for our ability to enroll these trials and focus on doing it expeditiously.

Operator: Thank you. The next question that we have is from the line of Andy Shea. Your line is open.

Andrew Ko: Oh, great. Thanks for taking my question. So I have two questions regarding the China market dynamics, maybe for Chris. So the trajectory in terms of hospital listings has been very impressive. So I'm just curious, as you kind of reach, You know, going from about 74 to 80 to 90 to the high 90 percent, what are some drivers that your team is thinking about in terms of continuing to grow that revenue line? And also, in terms of the kind

Andrew Ko: Periodicity of the national reimbursement dynamic

Andrew Ko: I think every single year there is some kind of scheduled pricing cuts mandated by the government. I'm just wondering, you know, what the fiber Jim China team is thinking about in terms of that propensity.

Andrew Ko: and kind of preparing for that. Thank you. I think I'll

Enrique A. Conterno: I think I'll have Chris indeed address both questions when it comes to drivers for revenue growth going forward in China's we tend to have increased there's a limit to even how well we've done with cost through listings in terms of how much will that continue to contribute and then also I think you made a question about the NRDL and I would say the negotiation for products happens every two years Not every year, although there's every year there's some product that will be English-ed-Crist.

Christine L. Chung: Sure, so to answer the first question, we think of hospitals.

Christine L. Chung: question, we think of hospital listings as market access. So until you are listed in a hospital formulary, no physician can dispense. So once you get your foot in the door, in this case, Roxadustad, you still need to convert.

Christine L. Chung: the prescribers one at a time. So let's say there are 35 nephrologists in a department.

Christine L. Chung: You don't get all 35 in the first day. You might get five. The next year, you might get 10, and hopefully, there's an upward trajectory.

Christine L. Chung: And for every single prescriber, let's say they have 200 patients, you also don't get the benefit.

Christine L. Chung: 200 on the first day. You might get 20, and then you might get 25%.

Christine L. Chung: If you get 25%, you might get 50%.

Christine L. Chung: Obviously, if we were successful, we'd love to get the

Christine L. Chung: but there's some art to the trajectory. So we see getting our foot in the door in terms of the success we have in hospital listening.

Christine L. Chung: So we see getting our foot in the door in terms of the success we have in hospitals listening to patients vote very, very well for future adoption, but really, we are at the very, very beginning of market adoption of Roxasduced. So 74% is very good, which means

Christine L. Chung: I hope that makes sense. The second question with regard to NRDL Enrique is absolutely correct: it's renewed every single two years.

Christine L. Chung: 2021, and the new price will be coming.

Christine L. Chung: effective in 2020.

Christine L. Chung: There are obviously a number of factors that they would consider in the price. First is the budget.

Christine L. Chung: of Rostad on the National Healthcare Budget. The second is the value proposition

Christine L. Chung: proposition of how much we actually save in healthcare costs.

Christine L. Chung: and many other factors into the value proposition. And third, it is really

Christine L. Chung: How strong is the market adoption?

Christine L. Chung: and how much prescribers value this drug. We remain confident in the outcome of price negotiations. To be clear,

Christine L. Chung: negotiations. To be clear, the price only goes in one way; it always goes down. It never goes up. So it's at the discretion of the NRDL in terms of how they value it and how much it goes down. Every single year, they come up with a different

Christine L. Chung: I find a set of criteria.

Christine L. Chung: but determining pricing. The 2019 one was different from the 2020 one.

Christine L. Chung: 2021 eligibility criteria and prior to

Christine L. Chung: The character characterization has not yet been announced.

Christine L. Chung: We're working very closely with market access at Estrogenica to demonstrate the value of our drug.

Christine L. Chung: and we remain confident about a very good outcome in Coup for this year at the price.

Christine L. Chung: for the price that will be effective for two years thereafter. Hey, Chris, this is, this is saying, if I could just maybe piggyback on to your answer on the China trajectory to answer, to provide some more color on Andy's first question. You know, this is really the first time we've provided some granularity around China performance over and above revenue and then snapshots of hospital listings and things of that nature.

Christine L. Chung: And so if you take a look at some of the slides that we provided, the first thing to reiterate is that we've got a market that, when you add the ESA growth on top of the category expanding nature of Rox deuce, it's a market that's really taken off, which really highlights the promotional responsiveness to this category. And then when you take a look at the market share perspective we've provided, which is a value-based market share at 27%.

Christine L. Chung: We're in the process of turning that value-based market share into a volume-based share calculation, which is a bit difficult given some of the dosing dynamics associated with EAS, but it's probably fair to say that our current volume penetration is much, much lower than 27%, which just speaks to the significant upside potential that RoxoGyStat continues to have in the Chinese market. And we think it's also, as Enrique said in his prepared comments, a really nice read-through to the other markets when we are able to launch in the U.S. and Europe.

Enrique A. Conterno: There are no further questions at this time. I would like to turn the call back to Enrique. Please go ahead, sir.

Enrique A. Conterno: Very good, thank you, Erica. We very much appreciate everyone's participation in today's investor call and your interest in Fibrogen. Please follow up with our investor relations team. If you have any questions, we have that addressed on the call. And enjoy the rest of your day. Thank you very much.

Operator: This concludes today's conference call. Thank you all for joining us. You may now discuss.

Operator: Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you, and so on the other, and so on.