Q2 2021 FibroGen Inc Earnings Call

[music].

Good day and thank you for standby welcome to the price of Gen second quarter 2021 financial results conference call at the time, all participants are in listen on them and after the Speakers' presentation. There will be a question and answer session to ask the question. During the session you will need to press the star 1 on your telephone keypad, if you recall.

Operator: Good day, and thanks for standing by. Welcome to the FibroGen 2nd Quarter 2021 Financial Results Conference Call.

Operator: At this time, all participants are enlisted on the moon. 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 star 1 on your telephone keypad. If you require any further assistance, please press star 0. As a reminder, this conference call is being recorded. If you would like to turn it over to Mr. Michael Tung, please do so.

And you produce distance. Please press star Zero as the reminder, this conference call is being recorded I'm not like to turn the call over to Mr. Michael Tung. Please go ahead.

Thank you Charlie good afternoon, everyone and welcome to farmers in the 2021 second quarter Conference call on Michael Tung, Vice President of corporate strategy and Investor relations of fiber to the.

Michael Tung: Thank you, Charlie. Good afternoon, everyone.

Michael Tung: Welcome to FibroGen's 2021 second quarter conference call. I'm Michael Tung, Vice President of Corporate Strategy and Investor Relations at FibroGen. Joining me on today's call are Enrique Conterno, our Chief Executive Officer; Pat Cotroneo, our Chief Financial Officer; Dr. Mark Eisner, our Chief Medical Officer; Dr. John Hunter, our Chief Scientific Officer; Thane Wettig, our Chief Commercial Officer; and Chris Chung, our Senior Vice President of China Operations. The format for today's call includes prepared remarks from Enrique and Pat, after which we will open up the call I would like to remind you that remarks made on today's call may include forward-looking statements based on FibroGen's current expectations.

Joining me on today's call are Enrique Conterno, our Chief Executive Officer, Pat Cotroneo, Our Chief Financial Officer, Dr. Mark is of our Chief Medical Officer, Dr. John Hunter, Our Chief Scientific Officer, St Wedig, Our Chief commercial Officer, and Chris Chung, Our senior Vice President of China operations.

The format for today's call includes the prepared remarks from and regain Pat after which we will open up the call for Q&A I would like to remind you that remarks made on today's call may include forward looking statements based on fiber to the current expectations.

Michael Tung: So statements may include statements regarding

Such statements May include statements regarding to but not limited to our research and development activities. The initiation of enrollment design conduct and results of clinical trials of regulatory strategies of potential regulatory results.

Michael Tung: but not limited to our research and development activities, the initiation, enrollment, design, conduct, and results of clinical trials, our regulatory strategies and potential regulatory results, anticipated FDA interactions. Commercialization and Results of Operations, Risks, Plans, Market Opportunity, and Strategy related to our business, our collaborations with AstraZeneca and Astellas, Financial Guidance,

Anticipated FDA interactions.

Commercialization of results of operations risks plans market opportunity and strategy related to our business.

Our collaborations with Astrazeneca, and Astellas financial guidance and certain other business matters.

Michael Tung: and certain other business matters. These forward-looking statements are subject to significant risks and uncertainties that could cause actual results to differ materially from those anticipated in such statements. For discussion of these and other material risks and factors that could affect our future financial results in the business, please refer to the disclosure...

Forward looking statements are subject to significant risks and uncertainties that could cause actual results 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 and business. Please refer to the disclosure in today's press release reporting of our fiscal 2021 second quarter financial results and business update.

Michael Tung: Disclosure in today's press release reporting our fiscal 2021 second quarter financial results in business Our most recent forms 10-K and 10-Q and reports that we may file on form 8-K with the Securities and Exchange Commission. All our statements are made as of today, August 9, 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.

Our most recent forms 10-K and 10-Q.

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

All of our statements are made as of today August 9.2021 based on information currently available to us in 5 or 10 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 of our fiscal 2021 of the second quarter financial results and business update and a webcast of today's conference call can.

Can be found on the investors section of <unk> website at Www, <unk> dot com with that I would like to turn the call over to Enrique Conterno, our CEO Enrique.

Michael Tung: Today's press release reporting our fiscal 2021 second quarter financial results and business update and a webcast of today's conference call can be found on the investor section of FibroGen's website at www.fibrogen.com. With that, I would like to turn the call over to Enrique Conterno, our CEO. Thank you, Mike.

Thank you, Mike and good afternoon, everyone and welcome to our second quarter 2021 earnings call.

Today, I would like to provide a high level summary of important accomplishments on developments in recent months.

That's good for now our CFO will then review the financials after which we will open up the call for your questions.

There is no question, we are facing a significant challenge given the recent FDA Advisory Committee vote.

However, 5 region continues to be positioned to create significant value for patients on shareholders.

By executing on the 3 areas of focus of shown on slide 3.

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

Number 1 ensuring regulatory and commercial success of rocks of do start on <unk>.

The formation of medicine for the treatment of anemia.

First in patients with chronic kidney disease, and also with significant potential for expansion of the treatment of additional indications.

Number 2 developing from relevant being 3 indications with significant unmet medical need.

The local advanced Unresectable pancreatic cancer.

<unk> muscular dystrophy.

Enrique A. Conterno: There is no question we are facing a significant challenge given the recent FDA Advisory Committee vote. However, FibroGen continues to be positioned to create significant value for patients and shareholders by executing on the three areas of focus as shown on slide three. Number one, ensuring regulatory and commercial success for Roxadustat, a transformation of medicine for the treatment of anemia, first in patients with chronic kidney disease and also with significant potential for expansion to the treatment of additional indications. Number two, developing pambrelumab in three indications with significant unmet medical needs, locally advanced and respectable pancreatic cancer. Duchenne muscular dystrophy and idiopathic pulmonary fibrosis

The immediate party pulmonary fibrosis.

And number 3 is.

Strength in research productivity.

By leveraging our leadership position both in the hypoxia inducible factor and connective tissue growth factor of biology, and by accessing external innovation.

Today's call will include an update of the regulatory status of Brooks the boost that.

Continued strong performance in China, our clinical trial programs and recent corporate developments.

Let us get started with Brooks had the extent on slide 4.

In June.

The <unk> of the European Medicines agency.

Adopted a positive opinion.

Weighted through the use of Brooks of do stuff for the treatment of anemia associated with <unk>.

We expect the decision.

From the European Commission by the end of August.

In July the.

EBITDA cardiovascular and renal drugs Advisory committee voted to recommend not approving <unk> reduce debt for the treatment of anemia of <unk>.

Enrique A. Conterno: And number three, strengthening research productivity by leveraging our leadership position both in hypoxia-inducible factor and connective tissue growth factor biology and by accessing external innovation. Today's call will include an update on the regulatory status of Roxas Dustat, our continued strong performance in China, our clinical trial programs, and Recent Corporate Development. Let us get started with Brock Zadustan on slide four.

We on our partner Astrazeneca are in dialogue with the FDA on.

Expect on action in the near future.

During the quarter it looks it was approved in South Korea.

The treat adult patients with anemia of CTV on.

And we have regulatory submissions in other territories under under review.

To support commercialization efforts worldwide.

We have submitted manuscripts covering all primary phase III studies to peer review journals.

As noted in slide 5.

7 of these manuscripts have been published encompassing both non dialysis dependent on dialysis dependent data and we expect additional publications of the phase III data in the coming months.

Enrique A. Conterno: In June... The CHMP of the European Medicines Agency adopted a positive opinion relating to the use of Roxodusta for the treatment of anemia associated with CKD. We expect

Moving now to China.

As you can see on slide 6 we are pleased to report total rocks at this the net sales to distributors in China of $52.8 million for the second quarter on $96.3 million for the first half of 2021.

Enrique A. Conterno: A decision from the European Commission by the end of August. In July, the FDA Cardiovascular and Renal Drugs Advisory Committee voted to recommend not approving Roxadusta for the treatment of anemia in CKD. We and our partner AstraZeneca are in dialogue with the FDA and expect an action in the near future. During the quarter, Roxasdusta was approved in South Korea to treat adult patients with anemia or CKD. And we have regulatory submissions in other territories under review to support commercialization efforts worldwide.

The increase in uptake continues to be driven by both on expansion and cost per listings.

On broader adoption within the listed hospitals.

Coverage on reported $13.4 million in China of <unk> net product revenue for the second quarter of 2021 on.

On $28.7 million for the first half of 2021.

Hospira leases continue to be a key focus of our launch efforts on at the end of the second quarter rocks at the Sun was listed as hospitals, the collectively represent approximately 81% of the CK the anemia market opportunity in China.

As you can see on slide 7.

The USA market growth has accelerated since the inclusion of Brooks reduced debt on the NRT the al.

Enrique A. Conterno: We have submitted manuscripts covering all Primary Phase III studies to peer-reviewed journals. As noted in slide 5, 70 of these manuscripts have been published, encompassing both non-dialysis-dependent and dialysis-dependent data. And we expect additional publications of the phase 3 data in the coming months. Moving now to China.

In fact.

Is the revenue over the last 6 months has shown meaningful growth over the same period in the prior year.

Moving to slide 8.

Because of the has driven the expansion.

Of the anemia of CTV category over the past the year and a half.

In fact growth because its the capture 70% of the category growth on is capturing share and on expanding market.

Finally on.

Enrique A. Conterno: As you can see on slide six, we are pleased to report a total of the DusterNet sales to distributors in China of 52.8 million dollars for the second quarter and 96.3 million dollars for the first half of 2021. The increase in uptake continues to be driven by both an expansion in hospital listings and Broad Adoption with Enlisted Hospitals. FibroGen reported $13.4 million in China Roxadusta Net Product Revenue for the second quarter 2021 and $28.7 million for the first half of 2021.

As shown on slide 9 <unk> studies, the number 1 branded treatment for anemia in China for the past 5 months Ashish.

Achieving our value share of 32% in the most recent months within the segment that includes all Esa products on roof of Goose debt currently the only history of China market.

We look forward to keeping you updated as we advance our long term goal of making the Brooklyn to set the standard of care in treating China's TKD anemia patients.

Moving now to our clinical development programs on slide 10.

Covid.

Continuous the grid challenges to recruitment on.

Today, we are updating our timeline starting with rocks the distant.

Enrique A. Conterno: Hospital listings continue to be a key focus of our launch efforts, and at the end of the second quarter, Roxadista was listed in hospitals that collectively represent approximately 81% of the CKD anemia market opportunity in China. As you can see on slide 7...

We recently completed the Whitney our phase II trial in patients with the chemotherapy induced anemia.

And look forward to sharing top line data with you later this quarter.

Top line data of Matterhorn, our phase III trial in patients with anemia mill of dysplastic syndrome or Mds.

Is now expected in the second half of 2022 or first half of 2023.

Enrique A. Conterno: The ESA market growth has accelerated since the inclusion of Roxadustat on the NRDL. In fact, ESA revenue over the last six months has shown meaningful growth over the same period in the prior year. Moving to slide eight.

Versus prior guidance of the first half of 2022.

In China, the blinded portion of the phase III trial of <unk> in patients with anemia of MTS has begun enrollment.

Moving now to <unk>.

And locally advanced Unresectable pancreatic cancer on.

Enrique A. Conterno: Roxasuza has driven the expansion of the anemia of CKD category over the past year and a half. In fact, Roxasusta captures 70% of the category growth and is gaining share in an expanding market. Finally... As shown on slide 9, Roxadusta has been the number one branded treatment for anemic CKD in China for the past five months,achieving a value share of 32% in the most recent month within the segment that includes all ESA products and Rofecustat, currently the only HEIF PHI in the market.

The interim analysis of the event free survival.

First of all accelerated approval of our LAPIS phase III trial will be completed in the second half of 2022.

Previously the reflection of rate was the surrogate endpoint for accelerated approval.

After the recent discussions with the FDA, we changed this endpoint of the event free survival endpoint.

Which is composed of progression.

Deaths.

And resection failure due to progression the.

This better reflects the potential clinical benefit in this patient population.

During the second quarter umbrella of what's included in the pancreatic cancer action networks precision promise adaptive trial platform, which is evaluating <unk> on <unk>.

<unk> of care for patients with metastatic pancreatic cancer.

Enrique A. Conterno: We look forward to keeping you updated as we advance our long-term goal of making RoxyDustat the standard of care in treating China's TKD anemia patients. Moving now to our clinical development programs on slide 10. COVID continues to create challenges for recruitment, and today we are updating our timelines starting with Roxas Dustan.

Moving to Duchenne muscular dystrophy enrollment continues from the Atlantis, 1 phase II trial in non ambulatory patients with.

With top line data are now expected in the first half of 2023 versus prior guidance of second half of 2022.

Finally in idiopathic pulmonary fibrosis.

Today, we're pleased to provide guidance that we expect top line data.

From our <unk>, 1 phase III trial in mid 2023.

Enrique A. Conterno: We recently completed WHITNEY, our Phase II trial in patients with chemotherapy-induced anemia, and look forward to sharing top-line data with you later this quarter. Top-line data from Matterhorn, a phase 3 trial in patients with anemia or myelodysplastic syndromes or MDS, is now expected in the second half of 2022 or first half of 2023, versus prior guidance for the first half of 2022. In China, the blinded portion of the Phase III trial of Roxas-Dooster in patients with anemia of MDS has begun enrollment, moving now to Pambrello Map in locally advanced and resectable pancreatic cancer.

The silence assume current COVID-19 conditions.

And we will provide further updates a day of become available.

Moving now to the corporate update we appointed Dr. John Hunter to the position of Chief.

Scientific officer.

Moving now to slide 11 in June we announced our partnership with <unk> bio to advance next generation therapies for patients with cancer, and autoimmune disease, which could enable up to 3.

And these by 2023.

Fibrogenesis accessing 3 new monoclonal antibodies.

The exciting targets collecting 9.

<unk> 5 on CCR right.

Collecting 90% of oncology targets with the reported ROE in the acute myeloid leukemia and immune resistance in many solid tumors.

Enrique A. Conterno: An interim analysis of event-free survival for potential accelerator approval of our LAPIS Phase III trial will be completed in the second half of 2022. Previously, the reflection rate was a surrogate endpoint for accelerated approval. After recent discussions with the FDA, we changed this endpoint to the event-free survival endpoint, which is composed of progression, death, and resection failure due to progression. These better reflect the potential clinical benefit in this patient population. During the second quarter, PAMRELUMA was included in the Pancreatic Cancer Action Network's Precision Promise adaptive trial platform, which is evaluating PAMRELUMA and standard of care for patients with metastatic pancreatic cancer. Moving to Duchenne muscular dystrophy, Roman continues an allelantose 1 phase C trial in non-ambulatory patients, with top-line data now expected in the first half 2023 versus prior guidance of second Finally, nidopartic Pulmonary Fibrosis.

Next Dx share of 5 is on our immune oncology target on our primary interest autoimmunity.

But there are also opportunities.

In Brazil lymphomas.

Finally, <unk> share rate is on oncology targets.

With broad potential in solid tumors.

Now I would like to provide an update.

On our internal review.

On April 6.2021, the company clarified.

The certain previously disclosed cardiovascular safety analysis.

From the rocks of dose the phase III program for the treatment of anemia in chronic kidney disease included.

Both of changes to the stratification factors.

And provided additional data from the cardiovascular safety analysis with a prespecified stratification factors.

As stated at the time the.

Company initiated an internal review to ensure this does not occur in the future.

We now have completed the review.

The company findings from the review of our silos.

The underlying data used for the cardiovascular safety analysis are accurate with no data integrity issues with the data used to generate such analysis.

In its NDA the company calculated accurately and describe both set of analysis.

Including the statistical methodologies on the stratification factors utilized.

The statistical analysis using post hoc stratification factors were designated as the primary analysis.

Enrique A. Conterno: Today we're pleased to provide guidance that we expect top-line data from our Cephris 1 Phase 3 trial in mid-2023. These timelines assume current COVID conditions, and we will provide further updates as they become available. Moving now to the corporate update, we appointed Dr. John Hunter to the position of Chief, Scientific Office Moving now to slide 11, in June we announced our partnership with HiFiBio to advance next generation therapies for patients with cancer and autoimmune disease, a deal which could enable up to three, I end this by 2023. FibroGen is accessing three new monoclonal antibodies against exciting targets, Galectin-9.

On the statistical analysis, using Prespecified stratification of factor of sensitivity analysis.

Those responsible for the statistical analysis.

Believed it was a reasonable on valued way to analyze and present the data.

Management is taking steps to ensure the companys processes are consistent.

With best practices in all respects.

In addition to other processes and procedures, we plan to implement independent quality unity oversight of clinical data management programming analyses on reporting.

Furthermore, those directly response, so far the decision to use post hoc stratification factors in the primary analysis no longer work for the company.

The use of post hoc stratification factors was not discussed.

Enrique A. Conterno: CXCR 5, CCRA, Selecting 9, is an oncology target with a reported role in acute myeloid leukemia and immune resistance in many solid tumors. Next, TXTR5, is an autoimmune and oncology target, and our primary interest is autoimmunity, but there are also opportunities in better cell lymphoma. Finally, CCRH is an oncology target with broad potential in solid tumors.

But the FDA Advisory committee of references of consideration the led to.

The the advisory committee vote against the recommending approval for <unk>.

We do not believe that it played any role in debt vote.

I will now turn the call over to our CFO bulk of it for now for the financial update Pat.

Thank you Enrique as announced today total revenue for the second quarter of 2021 was $24.4 million as compared to $42.9 million per the second quarter of 2020.

Enrique A. Conterno: Now I would like to provide an update on our internal review. In 2021, the company clarified, The certain previously disclosed cardiovascular safety analysis from the Rochda Dusta phase three program, for the treatment of anemic chronic kidney disease, included. Post-hoc changes to the certification factors and provided additional data from the cardiovascular safety analysis with a pre-specified certification file. As stated at that time, the company initiated an internal review to ensure this does not occur again in the future.

The current quarter revenue consists of $13.4 million net.

Net product revenue for <unk> sales in China.

$19.6 million in developing revenue.

And the negative $8.6 million in drug product revenue, which reflects our estimate of the lower potential revenue from commercial batches shipped to date to astrazeneca in the U S. As a result of the recent unfavorable advisory Committee balance.

For the same period operating costs and expenses were $158.2 million and net loss was $134 million or $1.45 per basic and diluted share.

Enrique A. Conterno: We have now completed that review. Key company findings from the review are as follows. The underlying data used for the cardiovascular safety analysis are accurate, with no data integrity issues with the data used to generate such analysis. In its NDA, the company calculated accurately and described both sets of analysis, including the statistical, methodologies, and stratification factors utilized. The statistical analysis using post hoc stratification factors was designated as the primary analysis, and the statistical analysis using pre-specified stratification factors as the sensitivity analysis.

As compared to operating costs and expenses of $128 million and the net loss of $85.3 million or <unk> 95 per basic and diluted share for the second quarter last year.

Included in operating costs and expenses for the quarter ended June 32021 was the 1 time charge of $25 million.

<unk> to our partnership with high 5 buyout.

And an increase of approximately $20 million, which is primarily in perm revenue map development expenses.

As compared to the second quarter of last year.

Operating costs and expenses for the quarter also included a noncash charge of $19 million for stock based compensation expense as compared to $17.6 million of course.

Enrique A. Conterno: Those responsible for the statistical analysis believed it was a reasonable and valid way to analyze and present the data. Management is taking steps to ensure the company's processes are consistent with best practices in all respects. In addition to other processes and procedures.

<unk> based compensation expense for the same period in the prior year.

At June 35 of <unk> had 640 <unk> 5.

$5 million in cash cash.

Cash equivalents.

Strength of time deposits investments and receivables.

As we have previously disclosed starting the first quarter of 2021, the jointly owned distribution entity.

Enrique A. Conterno: We plan to implement independent quality unity oversight of clinical data management, programming, analysis, and reporting. Furthermore, those directly responsible for the decision to use post-hoc extratification factors in the primary and outpatient setting no longer work for the company. The use of post-hoc stratification factors was not discussed by the FDA Advisory Committee, a reference as a consideration that led... The advisory committee voted against recommending approval for Roxas Blue State. We do not believe that it plays any role in that vote.

Between AZ and fibre channel or the J D E began selling lots of do start to distributors and.

And pain for Astrazeneca us commercialization efforts in China and any of these portion of the profit share pre.

Previously <unk> was responsible for these items.

To provide context for the operating results of our lots of <unk> business in China.

Total lots of do stat, net sales, including sales through the JV to its distributors.

And fiber the in China is direct sales to our distributors was $52.8 million from the second quarter 2021.

Pat Cotroneo: I will now turn the call over to our CFO, Pat Cotroneo, for the financial update. Pat? Thank you, Enrique.

The JD accounted for over 97% of the total China rocks reduce debt sales volume.

Our net transfer price from sales to the JV was $17.1 million for the second quarter.

Pat Cotroneo: As announced today, total revenue for the second quarter of 2021 was $24.4 million, as compared to $42.9 million for the second quarter of 2020. The current quarter revenue consists of $13.4 million. Net product revenue for Roxadustat sales in China. $19.6 million

Which is within the 30% to 45% range of the JD ease of rocks reduced debt net sales to which we previously guidance.

After the net transfer price is determined we defer a certain portion of such net transfer price for revenue recognition purposes under U S. GAAP.

As a result, <unk> reported $13.4 million in China of rocks reduced debt net product revenue for the second quarter 2021.

Pat Cotroneo: And a negative $8.6 million in drug product revenue, which reflects our estimate of lower potential revenue from commercial batches shipped to date to AstraZeneca in the U.S. as a result of the recent unfavorable advisory committee vote. For the same period, operating costs and expenses were $158.2 million, and the net loss was $134 million, or $1.45 per basic and diluted share, as compared to operating costs and expenses of $128 million and a net loss of $85.3 million, or $0.95 per basic and diluted share, for the second quarter last year.

This amount also includes fiber Jens adjusted net transfer price of $11.7 million from sales to the J D E and the balance consisting of our direct sales to China distributors in China.

Looking ahead at our broader financial picture, we have a total of $120 million in potential milestones expected for anticipated EU approval in Didi and <unk> by year end.

Based on our latest forecast, we estimate our 2021 ending balance of cash cash equivalents restricted time deposits investments and receivables to be in the range of $480 million to $490 million.

Pat Cotroneo: Included in operating costs and expenses for the quarter ended June 30, 2021, was a one-time charge of $25 million related to our partnership with Hi-Fi Biome and an increase of approximately $20 million, which is primarily PAMREV-LUMAB development expenses as compared to the second quarter last year. Operating costs and expenses for the quarter also included a non-cash charge of $19 million for stock-based compensation expenses, as compared to $17.6 million for stock-based compensation for the same period in the prior year.

Assuming <unk> approval in 2021.

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

Thank you Pat and in closing.

<unk> reduced the continues to perform very well in China.

We expect the decision in.

In Europe by the end of August and.

And we have multiple regulatory submission under review in other geographies.

On relevant with the potential first in class medicine in phase III development in 3 indications with significant unmet medical need locally advanced Unresectable pancreatic cancer Duchenne muscular dystrophy.

The party pulmonary fibrosis.

Finally, we continue to advance the research agenda by advancing our internal candidates on accessing external innovation like the high for biodiesel.

As shown on slide 12, we continued to have a strong financial position.

With approximately $641 million in cash and another $120 million.

Pat Cotroneo: At June 30, FibroGen had $640.5 million in cash, cash equivalents, restricted time deposits, investments, and receivables. As we have previously disclosed, starting the first quarter of 2021, the jointly owned distribution entity between AZ and FibroGen or the JDE began selling Roxodustat to distributors and paying for AstraZeneca's commercialization efforts in China and AZ's portion of the profit share. Previously, FibroGen was responsible for these items to provide context for the operating results of our RoxaduSTAT business in China.

And anticipated Brooks of do some milestone payments expected during 2021, assuming EU approval later this year.

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

As a reminder, if you had the question at this time. Please press Star then the number 1 key on your Touchtone telephone. If your question has been answered or you wish to in the yourself from the queue price per pound key. Please limit your question to 1.1 follow on.

Your first question comes from the lineup Michael Lee the Jefferies. Your line's now open.

Pat Cotroneo: Total rocks-a-deuce that net sale, including sales through the JDE to its distributors and FibroGen China's direct sales to our distributors, was $52.8 million for the second quarter of 2021. The JDE accounted for over 97% of the total China ROC-SDU stat sales volume.

Hi, Thanks, good afternoon Enrique.

Just wanted to ask you about how to think about the upcoming <unk>.

Next steps after whatever FDA decision comes I mean, I think it's safe to say that the market assumes a negative decision and if that's the case how should we expect the ongoing partnership with Astrazeneca to progress and are you having discussions that would include all options on the table, maybe just talk to that because I think that that's what people are trying to figure out.

Pat Cotroneo: Our net transfer price from sales to the JDE was $17.1 million for the second quarter, which is within the 30 to 45% range of the JDE's Roxadustat net sales to which we previously guided. We defer a certain portion of such net transfer price for revenue recognition purposes under U.S. GAAP. As a result, FibroGen reported $13.4 million in China Roxaduce.net product revenue for the second quarter of 2021.

But the next step of going in the U S. Thank you.

Yes clearly.

I want to ensure the we don't get ahead of.

Of any FDA action.

But clearly you you have to assume that we're planning on all that.

The scenarios here.

Is going to of course based on our discussions and we've had some of the discussion with both <unk>.

The FDA and Astral.

Astrazeneca.

We need to we've been working basically to try to understand.

Pat Cotroneo: This amount also includes FibroGen's adjusted net transfer price of $11.7 million from sales to JDE and the balance consisting of our direct sales to Chinese distributors in China. Looking ahead at our broader financial picture, we have a total of $120 million in potential milestones expected for anticipated EU approval for DD and NDD by year-end. Based on our latest forecast, we estimate our 2021 ending balance of cash, cash equivalents, restricted time deposits, investments, and receivables to be in the range of $480 to $490 million.

On a potential pass.

Forward here.

We expect a decision I think it's difficult to say, we have not been given a.

Timeline for that but I think you know you witness the outcome of just like we did.

Of course, we were quite disappointed on the.

Surprised.

With the.

With the vote, the how debt discussion turn out on the final outcome of the vote.

Clearly under a scenario of a complete response letter will need to see what the details are for the complete response letter.

And make decisions appropriately but theres.

Theres no question on any of those scenarios, we will have to make significant reallocation of resources and on.

Corresponding.

The reduction in expenses with that.

Pat Cotroneo: Assuming EU rocks reduce that approval in 2021. Thank you. And I would now like to turn the call back over to Enrique. Thank you, Pat, and in closing... Rock Seduced continues to perform very well in China.

As I mentioned.

You mentioned.

We are expecting a decision in Europe.

By the end of this.

On a.

Months. So we are excited about that I don't know Mark if you want to make any additional comments. Thanks, Enrique I think you summarized it well I mean, we're working collaboratively collaboratively with FDA and Astrazeneca to find the path forward.

Enrique A. Conterno: We expect a decision in Europe by the end of August, and we have multiple regulatory submissions under review in other geographies. PAMRELUV is a potential first-in-class medicine in Phase III, developing in three indications with significant unmet medical need, locally advanced and receptable pancreatic cancer, Duchenne muscular dystrophy, and idiopathic pulmonary fibrosis. Finally, we continue to advance our research agenda by advancing our internal candidates and accessing external innovation like the HiFiBio deal. As shown on slide 12, we continue to have a strong financial position, with approximately $641 million in cash and another 120 million dollars in anticipated Roxas-Dousta milestone payments expected during 2021, assuming EU approval later this year. Now, I would like to turn the call back to the operator for questions.

And we await the Fda's decision and <unk>.

The next steps.

Thank you.

Your next question comes from the line of animal Sydney with Stifel. Your line channel.

Hi, Thanks for.

Taking my questions and.

I apologize if I missed the initial comments.

But maybe you can.

Sort of cash.

Talk to us about the chemotherapy induced anemia studies.

They're completely on clinical trials.

Can you tell us what in what form of that data might be reporting out and is there anything that you can pull from these studies that might help you address some of the issues that you came across in the.

In the dialysis and the non dialysis.

These studies.

And.

Yes.

That's essentially the question I'll wait.

I'll wait for debt.

Follow up with that.

So.

<unk>.

We've really finalized debt the.

The study for chemo induced anemia.

And at this point in time, we're expecting to report top line data.

Imminently I'm going to ask maybe mark Eisner to provide some more color on.

Whether any of these data can help.

Any type of discussions with the EBITDA on.

Operator: As a reminder, if you have a question at this time, please press star then the number 1 key on your touch-tone telephone. If your question has been answered or you wish to remove yourself from the queue, press the pound key. Please limit your question to 1 and 1 follow-up. Your first question comes from the line of Michael Yee with Jeffries. Your line is now open.

How do we think about these data.

So thanks, it's it's an interesting question I think the short answer is no I mean chemotherapy induced anemia, and <unk> are very different indications very different patient populations. So I don't see.

Informing the CK D decision or the the assessment there.

We feel we're looking forward it to the to see the top line data of the phase II data.

Looking forward to sharing knows shortly and thinking about what the pathway could be for CIA is as an indication.

Michael Jonathan Yee: Hi, thanks. Good afternoon, Enrique. Um, we just wanted to ask you about how...

Okay.

Great and if I could just ask on.

Michael Jonathan Yee: How to think about the upcoming next steps after whatever FDA decision comes. I mean, I think it's safe to say that the market assumes a negative decision. And if that's the case, how should we expect the ongoing partnership with AstraZeneca to progress? And are you having discussions that would include all options on the table? Maybe just talk about that because I think that that's what people are trying to figure out with the next step in the year.

Obviously, it was clear from from the panel of bad debt.

The physicians want to see.

On the titration study not a.

The stimulated modeling study of what.

As you can do.

Given that these thrombotic events occur earlier.

Treatment do you think that titration study would be relatively short.

This is something that can be conducted rapidly.

Alright.

Thinking about this incorrectly.

Mark.

Yes, thanks for the question.

Enrique A. Conterno: I'll put the next step would be in the U.S. Thank you.

Just to start out to say that we believe that the benefit risk of rocks of do start for the treatment of CK. The anemia in both the <unk> and DD populations as is favorable with the dosing regimen that we studied in phase III, but we did collaborate with FDA on some analyses as you know looking at rate of rise of heme.

Enrique A. Conterno: Yeah, clearly, I want to ensure that we don't get ahead of any FDA action. But clearly, you have to assume that we're planning for all scenarios here. And it's going to, of course, be based on our discussions, and we had some discussions with both the FDA and AstraZeneca. We need to, we've been working basically to try to understand a potential path forward here. We expect a decision soon, but I think it's difficult to say.

Globe and the relationship with thrombotic events, and we do believe that starting at a lower starting dose of <unk> and tight trading up will be a very reasonable approach to treating patients in mitigating the risk. We actually don't believe another trial is needed to prove the hypothesis its well established.

Bush of the Esa field over the last 2 or 3 decades.

We think the same applies with rocks do stop.

Enrique A. Conterno: We have not been given a timeline for that, but I think, you know, you will witness the outcome just like we did. Of course, we were quite disappointed and surprised by the vote and how that discussion turned out and the final outcome of the vote. Clearly, under a scenario of a complete response letter, we'll need to see what the details are for that complete response letter and make decisions accordingly. But there's no question that under any of those scenarios, we will have to make significant reallocation of resources and corresponding reduction in expenses with that.

In terms of what study the FDA may or May not ask us to do this remains an open question and I think it's difficult to speculate right now than we were just waiting for it.

But from the agency on that.

Yeah.

Your next question comes from the line of the choppy for the SBB Leerink. Your line is now on me.

Pardon me on the police your line is now open.

Thank you very much apologies I was on mute.

I was just wondering could you tell us whether there's been any correspondence from the EMA.

Since the AD com requesting additional information or analysis.

Or is the file that you originally submitted.

Beyond the information you've been asked to provide and then secondly.

Just in terms of the expenses.

Enrique A. Conterno: As I mentioned, we are expecting a decision in Europe by the end of this month, so we are excited about that. I don't know, Mark, if you want to make any additional comments. No, thanks, Enrique. I think you summarized it well. We're working collaboratively with FDA and AstraZeneca to find the path forward, and we await the FDA's decision and next steps.

I think by the end of the year. It looks like you have about $460.470 million and net cash.

The burn rate this quarter of $134 million I know there were 1 time items in that burn rate, but.

It looks as though by the end of the year you might have a year to year on a half of cash left.

What are the options you have the significantly reducing the company's cash burn so that you don't need to refinance the company at this greatly impaired valuation level. Thanks.

Annabel Eva Samimy: Your next question comes from the line of Annabel Samimy with STFL. Your line is now open.

Annabel Eva Samimy: Hi, thanks for taking my questions. I apologize if I missed the initial comments, but maybe you can, you know, sort of... talk to us about the chemotherapy-induced anemia studies. I saw that they were completed on clinicaltrials.gov. Can you tell us when and in what form that data might be reporting out, and is there anything that you can pull from these studies that might help you address some of the issues that you came across? in the dialysis or the non-dialysis CKD studies. And yeah, that's essentially my question. I'll wait for them to follow up with my own. Yes.

Okay.

Mark do you want to discuss the first part of the question I'll discuss the burn rate sure. So the question is since YOD Com has there been any communication from or to EMEA answer to my knowledge, There's no theres been on and we don't anticipate any impact on the European Commission decision in August.

Great. Thanks, Yeah.

Yeah on the.

Your question about the burn rate.

We first I think we have no intention of raising money I think we have I'm sorry.

You mentioned the number of scenarios that we're working on clearly under a scenario of a complete response letter we would.

I need to.

Basically we reassess our priorities and reallocate our resources on significantly decrease expenses.

Enrique A. Conterno: So we've really finalized the phase two study for chemo-induced anemia, and at this point in time, we're expecting to report top-line data imminently. I'm going to ask Mark Eisner to provide some more color on whether any of this data can help any type of discussion with the FDA or how we think about this. So thanks. It's an interesting question.

There are a number of plants that we have to ensure that we can.

Deliver value for shareholders.

And clearly under that scenario, yes, we do have the do set in China and a number of markets.

And keep in mind, the China's now basically profitable.

On in the rest of the markets, we do not.

We are reimbursed for any expenses. So we do not have any expenses when it comes to both commercial and development expenses, we will be getting a royalty.

Mark Eisner: I think the short answer is no. I mean, chemotherapy-induced anemia and CKD are very different indications, very different patient populations. So I don't see CIA informing the CKD decision or the assessment there. That said, we're looking forward to seeing the top line data, the phase two data, and looking forward to sharing those shortly and thinking about what the pathway could be for CIA as an indication.

And of course, we need to ensure the we can get to the readouts of the umbrella them up.

As soon as possible so that's our priority 1.

But yes. There is there is no question the we though.

We have to.

Ensured that we are going to be able to.

Basically bridge for us to be able to.

See the data and be able to launch by revenue per month.

Alright, thank you.

Your next question comes from the line of Edwin Zhang from H C. Wainwright. Your line is now open.

Hi, Thanks for taking my question.

Annabel Eva Samimy: Obviously, it was clear from the panel that the physicians want to see a titration study, not a simulated modeling study of what titration can do. Given that these thrombotic events occur earlier in treatment, do you think that a titration study would be relatively short? Is this something that could be conducted rapidly, or am I thinking about this incorrectly?

On top line revenue can you help us understand why the net is OXXO revenue that's of fiber to improve.

This quarter.

The 2 meaning less than last quarter, while the total net revenue on the hospital listings will actually both increasing.

Also do you expect on the Iraq, the price pressure in the Colombian upcoming.

Negotiation in China, and then the have a follow up.

Mark Eisner: Thanks for the question. And just to start out to say that, you know, we believe that the benefit-risk profile of roxidustat for the treatment of CKD anemia in both the NDD and DD populations is favorable with the dosing regimen that we studied in phase three. But we did collaborate with FDA on some analyses, as you know, looking at the rate of rise of hemoglobin and the relationship with thrombotic events. And we do believe that starting at a lower starting dose of roxidustat and titrating up would be a very reasonable approach to treating patients and mitigating the risk.

Okay.

Yes, I'm going to ask maybe.

Pat to comment on the.

The first question on the net revenue.

The fabric and booked 2 million less of while the.

Overall sales to distributors of basically continuing to increase by the way of course, we see the overall net sales to distributors.

Really the.

The fundamentals of the business and the 1 thing to be able to look at.

We will have Pat Cotroneo, our CFO address that question and then we'll have Kris.

Talk about.

On the.

Mark Eisner: We actually don't believe another trial is needed to prove that hypothesis. It's well-established in the ESA field over the last two or three decades, and, you know, we think the same applies with roxidustat. In terms of what study the FDA may or may not ask us to do, this remains an open question. It's difficult to speculate right now, and we're just waiting for input. Your next question.

In Rds on what are our expectations there.

Thank you every day and thank you for the question. Yeah of course, just just as a reminder, as I as I mentioned.

On my prepared remarks.

We have deferred revenue.

And this is from adjustments of our net transfer price to reflect U S. GAAP.

The adjustments are required for accounting purposes, because we have manufacturing and supply obligations to the JV over an estimated performance period, so what youre seeing here.

Just the deferral of.

A portion of the revenue the latter years.

Operator: Your next question comes from the line of Joffrey Forges with SBB Learning. Your line is now open. Pardon me, Mr. Porges, your line is now open.

And and.

As accordingly, we deferred $3.9 million on Q1 of 2021 and then the <unk>.

<unk> 5.4 million on Q2 of 2021. So this is strictly related to performance obligations and the GAAP requirements under revenue recognition of homes.

Operator: Thank you very much. Apologies; I was on mute.

Operator: Could you tell us whether there's been any correspondence from the EMA since the adcom requesting additional information?

Chris Chris.

On your comment on the <unk>.

Absolutely Enrique.

With regard to end RTL as to the question of whether they don't see a change in pricing starting next year. The answer is yes per the rules of NR GL every single 2 years.

Operator: or analysis, or is the file that you originally submitted the only information you've been asked to provide?

Operator: And then, secondly, just in terms of the expenses.

Operator: I think by the end of the year, it looks like you'll have about $470 million in cash. And you had a burn rate this quarter of 134 million. I know there were one-time items in that burn rate, but it looks as though by the end of the year, you might have a year to a year and a half of cash left. What are the options you have to significantly reduce the company's cash burn so that you don't need to refinance the company at this greatly impaired valuation level? Thanks.

The price is being negotiated as you know last time, we entered and RTL in January 1st 2020, and we'll have a new price for 2022 January 1st the direction of these negotiations is always downward. So it's not a question of whether that how much.

There is a very well established process in terms of how prices are determined.

Is typically based on clinical value and we stand behind the clinical value of demonstrated by rock city of Scott.

Mark Eisner: Mark, do you want to discuss the first part of the question? I'll discuss the burn rate. Sure. So the question is, since the outcome, has there been any communication from or to EMA? The answer, to my knowledge, is no; there's been none.

And as you have seen in the very kind of sales on the last couple of quarters. We ask the very strong key opinion leader support from clinical key opinion leaders pharmacologists on pharmacies finally.

Fiber to the Investor Zeneca believe that we're uniquely positioned as an innovative drug too.

Enrique A. Conterno: And we don't anticipate any impact on the European Commission decision. On your question about the burn rate, first, I think we have no intention of raising money. I think we have, as I mentioned, a number of scenarios that we're working on. Clearly, under a scenario of a complete response letter, we would need to basically reassess our priorities and reallocate our resources and significantly decrease expenses. There are a number of plans that we have to ensure that we can... deliver value for shareholders.

Deliver value not just to patients but to the health care system. So we remain optimistic in terms of of what the pricing outcome might look like in Q4.

Great.

On the U S.

I was also wondering of what your future plan on rock the <unk> anemia in the U S are you willing to do additional safety studies and prepare for the Resubmission of some years later or would you rather dropped the CTD of anemia indication in the U S. Assuming the role.

Enrique A. Conterno: And clearly, under that scenario, yes, we do have Rochda Dosta in China in a number of markets. But keep in mind that China is now basically profitable. We are reimbursed for any expenses, so we do not have any. And, of course, we need to ensure that we can get to the readouts of PAMBRELUMAP as soon as possible, so that's priority number one. But yeah, there's no question that we have to ensure that we are gonna be able to basically bridge the gap for us to be able to see the data and be able to launch PAMBRELUMAP.

Once we receive FDA approval. Thank you.

Yes, as we mentioned, we don't want to speculate.

On the action by the FDA and of course.

If we were to get a complete response letter what would be the terms of the complete response letter. So it's difficult to comment on your question without having the action on any potential of specifics there.

Your next question comes from the line up Yaron Werber Cowen Your line is name of them.

Great. Thanks for.

Taking my questions I have a couple of questions that are interrelated to Enrique if I can the first 1 just given valuations in China right now on companies in China that are dual listed are listing in Hong Kong.

Operator: Your next question comes from the line of Edwin Zhang with HC Wainwright; your line is now Hi, thanks for taking my question. On China revenue, can you help us understand why the net ROXA revenue that FibroGen booked this quarter was 2 million less than last quarter, while the total net revenue and hospital listings were actually both increasing? Also, do you expect any rocket pricing pressure in the upcoming NRDL negotiation in China? And then there is a follow-up.

The ever been of discussion to see whether you should spin out the China sub into its own independent company and sort of rewrite the valuations there and then secondly, depending on which way of FDA goes here from something small to a whole new study in the much more complicated development path in case AZN decides that this might not fit in with.

The strategy can day exit the partnership in the U S, but remain intact with the on China or is it all of 1 size fits all thank you.

Yeah, clearly when it comes to China, We think that we have a meaningful business in China on meaningful capabilities of shown by the type of results from performance that were basically getting there.

Edwin Zhang: Yeah, I'm gonna ask maybe Pat to comment on the first question on net revenue, FibroGen booked a million less while the overall sales to distributors basically continued to increase. By the way, of course, we see the overall net sales to distributors as really the fundamentals of the business and one thing to be able to look at. The NRDL and what are our expectations.

Yes, we're looking at on.

We've looked at all options on we're looking at all options in China to ensure that.

The value that we have there is basically better reflected on on our share Bryan so.

That's the assumption that we are very much looking at.

When it comes to the partnership.

Enrique A. Conterno: Thank you, Enrique, and thank you for the question. You know, to start, just as a reminder, as I mentioned in my prepared remarks, we have deferred revenue, and this is from adjustments to our net transfer price to reflect U.S. GAAP. These adjustments are required for accounting purposes because we have manufacturing and supply obligations to the JDE over an estimated performance period. So, what you're seeing here is just a deferral of a portion of the revenue to the latter year.

The partnership with the both the Astellas and Astrazeneca is.

A very collaborative at this stage despite the very negative outcome of the outcome that we've had in the U S and I expect that that's going to continue to be the case, we clearly went on.

Hum.

See the FDA action.

And we do have additional indications of what percentage of keep in mind that the Mds is ease.

The phase III trial ongoing and we are about the seed the CIA data.

And of course based on.

The underlying data we will be hum.

Enrique A. Conterno: And, and, you know, accordingly, we deferred $3.9 million in Q1 of 2021 and then approximately $5.4 million in Q2 of 2021. So, this is strictly related to performance obligations and, and, and the gap requirements under revenue recognition.

Making the decision about how do we.

Proceed with that indication.

Yeah.

Your next question comes from the line of Andy <unk> with William Blair. Your line is now.

Oh, great. Thanks for taking my question. So what are the take home messages from the AD Com is that there is tremendous.

In the interest from the physician community about the hypo responders.

And on that.

Asking about making projections, but I wanted to understand the collaboration framework, So let's say hypothetically.

Pat Cotroneo: Remedy Recognition Homes

If the parties decided to go forward with that debt.

Our study.

Enrique A. Conterno: Chris, can you...

How is the decision being made is there like a joint steering committee.

Christine L. Chung: Absolutely, Enrique. So with regard to NRDL, as to the question of whether there will be a change in pricing starting next year, the answer is yes, per the rules of NRDL every single two years. The price is renegotiated. As you know, last time we entered NLDL on January 1st, 2020, and we will have a new price for 2022, January 1st. The direction of these negotiations is always downward, so it's not a question of whether or not, but how much.

Across the 3 company to make a go or no go decision and then also I guess from the financial perspective.

Is there additional cost from the fiber Jane.

Standpoint on on R&D or you have.

<unk> already hit the limit.

Yes, and then the second question I have 4 of Chris.

Looking at slide number 8.

It seems like the USA market in China.

Is is growing and then it seems like you're basically growing both the Esa and obviously the Rockies debt I'm. Just curious if you can comment on the dynamic are you kind of growing the market or is there also some element of switching from from Esa.

Christine L. Chung: There is a very well-established process in terms of how prices are determined. It is typically

<unk>.

Yes.

Maybe just let me try to address the question about.

Christine L. Chung: based on clinical value, and we stand behind the clinical value demonstrated.

<unk> expenses when it comes to.

Christine L. Chung: And as you have seen in the very strong sales in the last couple of quarters, we also have very strong...

Commercial or development expenses for <unk> that goes that as I mentioned outside of China. We have no expenses related the root cause of do start either on the commercial or the development side.

Christine L. Chung: Finally, FibroGen and AstraZeneca believe that we're uniquely positioned as an innovative drug to deliver value not just to patients but to the healthcare system. So we remain optimistic in terms of what the pricing outcome might look like in Q4 this year.

So we are fully reimbursed and that will be the case as well if we were to pursue additional trials.

I'm going to ask maybe mark to comment on.

The governance that we have how is the Howard decisions made.

When it comes to additional trials.

In particular I think there was this.

Operator: Great. I have a follow-up on the U.S. I was also wondering, what's your future plan for roxa-ECKD anemia in the U.S.? Are you willing to do additional safety studies and prepare for resubmission some years later? Or would you rather...

Question about trials in each of the Hypo responders Mark alright, so the ease of hyper responder group I mean, you're quite right. Several members of the Advisory Committee.

Noted the debt.

High unmet need for patients and we're intrigued by our data both in patients with high systemic inflammation and functional iron deficiency of the actually we have some data. The 2 suggests a rock to start is effective in east of the hyper responders. If we were true embark on another trial it would be a joint decision.

Operator: drop the STD anemia indication in the U.S., assuming a rough population.

Operator: and Roxa won't receive FDA approval. Thank you.

Enrique A. Conterno: Yeah, as we mentioned, we don't want to speculate on the action by the FDA and, of course, if we were to get a complete response letter, what would be the terms of that complete response letter? So it's difficult to comment on your question without having the action and any potential specifics.

Between <unk> and Astrazeneca and fiber Gen and Astellas I mean, we of joint steering Committee governance at the higher level and we have governed instead of more team level on <unk>.

<unk>.

Both companies and we aim to make decisions that are good for the tripartite net.

Everyone is aligned on so we do have.

Good governance procedures in place highly collaborative relationships with both companies.

Operator: Your next question comes from the line at P.I. and Werber with Callan, your line's name.

Once we know what the Fda's expectations are on will be in a good position to move forward.

Operator: Great, thanks for taking my questions. I have a couple of questions that are interrelated, Enrique. The first one, given the valuations in China right now for companies in China that are dual listed or listed in Hong Kong, has there ever been a discussion to see whether you should spin out the Chinese sub into its own independent company?

And Chris if you could comment on.

Brooks.

In China of whether it's just growing the market or the so so there is you just sort of capturing new patients versus just the switching I don't know I don't know if you could provide some additional color to that.

Absolutely and we take so the answer to the question is it is both.

Operator: depending on which way FDA goes here from something.

Category of Isa and assets together in the class of anemia treating agents, it's growing it's growing because there is increase the awareness of the importance of treating the disease.

Operator: small to a whole new study and a much more complicated development path. And in case...

Operator: In the end, they decide that this might not fit in with their strategy. Can they exit the partnership in the U.S. but remain intact with you?

The class share of his is also growing and we are seeing conversion of patients from east net to Hess.

Operator: Contact with you in China, or is it a one-size-fits-all? Thank you. Yeah.

Your next question comes from the line of.

Enrique A. Conterno: Yeah, clearly, when it comes to China, we think that we have a meaningful business in China and meaningful capabilities, as shown by the type of results and performance that we're basically getting there. And yeah, we're looking at, and we've looked at all options, and we're looking at all options in China to ensure that the value that we have there is better reflected in our share price. So that's something that we are very much looking into.

My apologies.

Okay.

Just keep going.

Okay.

Charlie you can keep going.

Your next question comes from the line of <unk> Yang Mizuho. Your line is now moving.

Hi, good afternoon, Thanks for taking my question.

I'm just curious how do the Chinese doctors react too clearly split the opinion between.

The EU regulatory agency versus the <unk>.

And do you expect.

The grabbing the C will eventually lead to.

Enrique A. Conterno: When it comes to the partnership, the partnership with both Stellas and AstraZeneca is very collaborative at this stage, despite the very negative outcome that we had in the U.S. And I expect that that's going to continue to be the case.

From changes in the.

Demand for Iraq.

No.

I'm going to ask Chris to maybe comment on.

The.

Reaction in China on I would try to complement of Chris's comments.

Enrique A. Conterno: We clearly want to see FDA action, and we do have additional indications that we're pursuing. Keep in mind that MDS is a phase three trial ongoing, and we are about to see the CIA data. And, of course, based on that underlying data, we will be making a decision about how we proceed with that in

Absolutely.

On China has a slightly different patient population.

Covered in the global trials.

And based on our historical phase III experience as well as the way of World evidence based on 2 and a half years, Jeff on market used in China.

Operator: Your next question comes from the line at Andy Isha with William Blair. Your line is now open.

Operator: Oh, great. Thanks for taking my question. So, you know, one of the take-home messages from the adcom is that there is tremendous, you know, interest from the physician community about the hypo responders. So, you know, I'm not asking about, you know, making projections, but I want to understand the collaboration framework. So, let's say, hypothetically, if the parties decide to go forward with that,

Chinese key opinion leaders are seeing slightly different is that right.

At this point in time, we're not seeing any older concern by our key investigators and key opinion leaders from Hcp's about the U S.

Regulatory.

Guidance based on the AD Com as you know every single Health authority makes its own sovereign decision.

By the King China sought approval of China based on a domestic class 1 when pathway, which meant that the data with only based on China data and to date. We will evidence is consistent with that experience. So at this point in time, we're not expecting any.

Operator: That, you know, is a study.

Operator: How is the decision being made?

Operator: Is there a joint steering committee across the three companies to make a go and no-go decision? And then also, from a financial perspective, are there additional costs from the FibroGens?

Impact or any significant impact.

Operator: you know, a standpoint on R&D, or you have already hit the limit.

On prescription levels and continued widespread adoption of rough to do just that in China of based on the outcome outcome.

Operator: Yeah, and then the second question I have for Chris, you know, looking at slide number eight. It seems like the ESA market in China is

Okay.

I think it's fair to say, we as part of the outcome, we shared some data on.

Real World data on when it comes to Pharmacovigilance in China.

Operator: And then, you know, it seems like, you know, you're basically growing both the ESA and, obviously, the Roxas Eastside. I'm just curious, you know, if you can comment on the dynamic. Are you kind of growing the market, or is there also some element of switching from ESA?

We saw some of the reported rates in the real world when it comes to thrombosis for example.

We're very very low.

Okay. Thank you.

For that and then my other question is related to the.

Enrique A. Conterno: Maybe just let me try to address the question about FibroGen's expenses when it comes to commercial or development expenses for Roxas Dustat. As I mentioned, outside of China, we have no expenses related to Roxas Dustat, either on the commercial or development side.

Well some of the trials more specific.

At the Mds trial as.

As well.

I'm sorry.

Yeah, it's the MD.

The trial as well.

Wow.

And so could you give us the little bit more color of what's causing that.

The.

The slow enrollment or is there something else.

Enrique A. Conterno: So we are fully reimbursed, and that would be the case as well if we were to pursue additional trials. I'm going to ask Mark to comment on the governance that we have, how decisions are made when it comes to additional trials. In particular, I think there was this question about trials in ESA hyporesponders. Mark?

Yes, we will provide a little bit of.

The comment is really related to enrollment.

And of course enrollment is also.

Impacted by current conditions, and we are seeing right now.

Conditions.

That are more challenging due to COVID-19. So some of the COVID-19 concerns.

Mark Eisner: Right. So, the ESA hyporesponder group, I mean, you're quite right. Several members of the advisory committee noted that that was a high unmet need for patients and were intrigued by our data, both in patients with high systemic inflammation and functional iron deficiency, that actually, we have some data that do suggest Roxitustat is effective in ESA hyporesponders.

And clearly that that creates a.

A bit of a disproportion of impact when you look when we look at our trials.

In 3 patient populations.

Mds.

The M D on IPF and the current timelines that we provided assume the current conditions basically continue on Mark would you like to share more color sure and we cannot agree with the comments about Covid I mean for Mds as you know.

Mark Eisner: If we were to embark on another trial, it would be a joint decision between FibroGen and AstraZeneca and FibroGen and Astellas. I mean, we have joint steering committee governance at the higher level, and we have governance at a more team level with both companies, and we aim to do things that are good for the tripartite and that everyone is aligned on. So we do have good governance procedures in place, and highly collaborative relationships with both companies.

I mean, it's a rare disease.

The 52 week placebo controlled period.

So it's challenging to find the patients to enroll we have opened up more than 40 additional sites around the world and we are seeing increases in enrollment in those sites. So we're making every effort to enroll the the Mds trials and the way I would characterize it is it's just there's a lot of uncertainty around the enrollment rates amongst them.

Month, and we are pushing very hard on working very collaboratively with our investigators to enroll those trials I mean, DMD. Similarly, the very rare disease.

These are young kids in many cases.

And the Covid situation looms large for the parents of those children in those children. So again, we're trying very hard to make those trials as user friendly as possible and doing everything we can to enroll those on the positive side I mean, the camera of them out of <unk> trials are actually enrolling very very well, which I think speaks to the high on the medical.

Mark Eisner: And once we know what the FDA's expectations are, we'll be in a good position to, And Chris, if you could comment on Roxa, China, whether it's just growing the market, or it's also there, capturing new patients versus just switching. I don't know if you could provide some additional color on that. Absolutely, Enrique. So the answer to the question is it is both. The category of ISA and HIF together in the class of anemia treating agents is growing.

Need in that condition on the excitement around Pam for those conditions. So that's that's very favorable in the first 1.

IPF timelines, we've announced for the first time publicly because we are making very good headway with enrollment there despite COVID-19.

Operator: It's growing because there is increased awareness of the importance of treating the disease. The class share of HIF is also growing, and we are seeing conversion of patients from EISNER to HIF. Your next question comes from the line of, my apologies.

Adding additional sites working closely with the sites.

To enroll those patients and also with the Galapagos Gilead. The discontinuation you know we've been working to try to capture of the patients who otherwise would have been candidates for those trials into our trial. So on.

That's looking pretty good right now.

Operator: Your next question comes from the line of... My apologies, ma'am. Just keep going. Charlie, you can keep going. Thank you, sir. Your next question comes from the line at D.J. Yang with Mizzou. Your line is now open.

Your next question comes from the line of Paul of choice with Goldman Sachs. Your line's now open.

Hi, everyone. Thank you for taking our questions. This is Charlie on for Paul.

I had a quick 1 regarding the upcoming European decision and subsequent events.

Operator: Hi, good afternoon, and thanks for taking my question. I'm just curious, how do the Chinese doctors react to clear...

What are how are conversations going with partner Astellas for the region are they talking about there.

Commercialization strategies pending the approval with the EMA are they going to be focusing on certain countries at this point.

Operator: This is really a split opinion.

Operator: between the EU Regulatory Agency versus the U.S., and do you expect this discrepancy will eventually lead to some changes?

Operator: Some changes in the demand for Roxa in China

The incorporating any sort of kind.

The virtual the remote.

Enrique A. Conterno: I'm going to ask Chris to maybe comment on the reaction in China, and I will try to complement his comments.

<unk> efforts considering the.

The potential pressure further COVID-19 Lockdowns later this year. Thank you very much.

Very good I'm going to ask our Chief Commercial Officer, Spain, where inc to provide some comments on.

Christine L. Chung: Absolutely. China has a slightly different patient population than what was covered in the global trials. And based on our historical phase three experience, as well as real world evidence based on two and a half years

On.

The commercialization strategies in the.

Europe wherever we can share thing yeah, thanks, Enrique and thanks, Charlie for your message. Unfortunately, we're not going to be able to comment very much with astellas as you can imagine.

Christine L. Chung: and a half years of on-market use in China, our Chinese key opinion leaders are seeing slightly different events.

And the highly competitive situation.

Christine L. Chung: At this point in time, we're not seeing any over-concern by our key investigators and key opinion leaders and HCPs about the U.S. Regulatory Guidance based on the ADCOMM. As you know, every single health authority makes its own sovereign decision. FibroGen China sought approval of China based on a domestic class 1.1 pathway which meant that the data was only based on Chinese data, and to date, our real world evidence is consistent with that experience. So at this point in time, we're not expecting any impact or any significant impact.

There are certain things that they're not going to disclose when we we can't disclose on their behalf I think what you could assume is that relative to a European launch, it's going to take the form of.

The other products that would be launching in Europe. So the the traditional markets that are first to launch will be the traditional markets that will be first launch for <unk> debt in Europe as they then work through the other markets from a pricing and reimbursement perspective.

Needless to say Theres, a lot of excitement because we do have a really nice competitive advantage in the EU from a timing perspective, and I think you can rest assured that the astellas is going to take full advantage of that.

Christine L. Chung: on prescription levels and continued widespread adoption of Roxaducet in China based on the Atcom outcome.

1 just to remind everyone that <unk> guided to.

2 revenue on.

Of $80 million per fiscal year 2021.

Enrique A. Conterno: I think it's fair to say that, as part of the outcome, we shared some data on... (inaudible)

That's 80 million it's.

It was converted that the exchange rates at the time from yen about half of that was Japan, if I recall correctly on about half of that was for our sellers was basically Europe outside of Japan.

Operator: Okay, thank you for that. And then my other question is related to the delays in some of the trials, more specifically, the MDS trial as well as, sorry, let me explain. Yeah, it's the MDS trial as well as the DMD trial. And so could you give us a little bit more color on what's causing this? Is it slow enrollment or is it something else?

So that's on the AR fit US also provided as part of the strategic review on overall.

Peak over the peak sales of expected for the product, which once again I'm I'm I'm translating from exchange rates at the time, but there were somewhere between half a billion U S dollars to $1 billion, Inc. Big revenue when we look at the Astellas territories.

Enrique A. Conterno: Yeah, we will provide a little bit of comment. It is really related to enrollment, and of course, enrollment is also impacted by current conditions, and we are seeing right now, um, DMD, and IPF. And the current timeline that we provided assumes that these current conditions basically continue on. Mark, would you like to share more color?

Great next question.

My apologies. Your next question comes from line of Jason <unk> with Bank of America. Your line of stand alone.

Hi, This is Perry on the line for Jason Thanks for taking our question.

Regarding the <unk> opinion.

Is there any risk that it doesn't stick and additionally.

Mark Eisner: Sure, Enrique, and I agree with the comments about COVID. I mean, for MDS, as you know, it's a rare disease. It's a 52-week placebo-controlled period, you know, so it's challenging to find patients to enroll. We have opened up more than 40 additional sites around the world, and we are seeing increases in enrollment in those sites. So we're making every effort to enroll patients in the MDS trials. And the way I would characterize it is that there's a lot of uncertainty around the enrollment rates month to month, and we are pushing very hard, though, and working very collaboratively with our investigators to enroll those trials. DMD, you know, is, similarly, a very rare disease.

1 of what are the next steps from a regulatory standpoint, and when can we expect to get a label in Europe. Thanks.

So as I mentioned, we're expecting a decision on.

This month.

Hum.

We.

Expecting a European Commission.

The decision clearly.

The scientific body of assess.

Brooks of do status of having a clear benefit risk profile keep in mind that many of the items. The wear discuss here were discussed as part of the review in Europe.

And I'm going to ask maybe mark to maybe make a few additional comments I think the point you made is the key 1 which is the <unk> has already reviewed all of the efficacy and safety issues that have been up for discussion in the U S and issued a positive opinion, we think the European Commission.

Mark Eisner: You know, these are young kids in many cases, and the COVID situation looms large for the parents of those children and those kids. So, again, we're trying very hard to make those trials as user-friendly as possible and doing everything we can to enroll these kids. On the positive side, I mean, the PAM-Revlimab LAPC trials are actually enrolling very, very well, which I think speaks to the high medical need for that condition and the excitement around PAM for those conditions.

The decision will be will be positive we don't expect the influence of the U S. Fda's outcome on that decision.

In terms of the next steps for regulatory in Europe, I believe it's just waiting for that.

<unk>.

The decision and then that's the point in time, where the.

The product and sort of the S. N P C in Europe will be come available.

So that's basically the regulatory situation in Europe.

Thank you.

We have no further question at this line I'll now turn the call back to our presenters for closing remarks.

Mark Eisner: So that's very favorable. And, you know, the Zephyrus 1 IPF timelines, we've announced for the first time publicly because we are making very good headway with enrollment there despite COVID, adding additional sites, working closely with the sites to enroll those patients, and also, you know, with the Galapagos-Gilead discontinuation, to try to capture the patients who otherwise would have gone into those trials into our trial, so that's looking pretty good

Yeah.

Very good I just want to.

Once again.

Just thank everyone for participating we very much appreciate your participation today.

On the.

The investor call on your interest in 5 region. Please enjoy the rest of the day. Thank you very much.

Ladies and gentlemen, this concludes today's conference call. Thank you for participating you may now disconnect.

[music].

Yes.

[music].

Operator: Your next question comes from the line of Paul Choi with Goldman Sachs. Your line is now open.

Operator: Hi, everyone. Thank you for taking our questions. This is Charlie. I'm on behalf of Paul.

Operator: I just had a quick one regarding the upcoming European decision and subsequent events. How are the conversations going with partner Astellas in the region? Are they talking about their commercialization strategies pending approval with the EMA? Are they going to be focusing on certain countries at this point? And are they incorporating any sort of kind of virtual or remote marketing efforts considering the potential threat for further COVID lockdowns later this year? Thank you very much.

Operator: Very good. I'm going to ask our Chief Commercial Officer, Thane Wettig, to provide some comments on the commercialization strategies in Europe, whatever we can share, Thane. Yeah, thanks, Enrique, and thanks, Charlie, for your message.

Thane Wettig: Unfortunately, we're not going to be able to comment very much. Astellas, as you can imagine, in a highly competitive situation, there are certain things that they're not going to disclose, and we can't disclose on their behalf. I think what you could assume is that, relative to a European launch, it's going to take the form of other products that would be launching in Europe. So the traditional markets that are first to launch will be the traditional markets that will be the first to launch Roxadustat in Europe, as they then work through the other markets from a pricing and reimbursement perspective.

Thane Wettig: Needless to say, there's a lot of excitement because we do have a really nice competitive advantage in the EU from a timing perspective, and I think you can rest assured that Astellas is going to take full advantage of that.

Enrique A. Conterno: One, just to remind everyone that Astellas has died, to revenue of $80 million for fiscal year 2021. That's $80 million. It was converted at the exchange rates at the time from yen. About half of that was Japan, if I recall correctly, and about half of that for Astellas was basically Europe outside of Japan. And Astellas also provided, as part of their strategic review, an overall peak sales expected for the product, which, once again, I'm translating from exchange rates at that time, but they were somewhere between half a billion U.S. dollars to a billion U.S. dollars in peak revenue when we look at Astellas' territory.

Operator: Great. The next question. My apologies. Your next question comes from the line of Jason Gerberry with Bank of America. Your line stands.

Operator: Hi, this is Perry on the line for Jason. Thanks for taking our question. I have another regarding the CHMP opinion. Is there any risk that it doesn't stick, and additionally, what are the next steps from a regulatory standpoint, and when can we expect to get a label in Europe? Thanks.

Enrique A. Conterno: As I mentioned, we're expecting a decision this month. We are expecting a European Commission decision. Clearly, the scientific body assessed Roxodusta as having a clear benefit-risk profile.

Enrique A. Conterno: Keep in mind that many of the items that were discussed here were discussed as part of the review in Europe. And I'm going to ask Mark to maybe make a few others. I think the point Enrique made is a key one, which is that the CHMP has already reviewed all of the efficacy and safety issues that have been up for discussion in the U.S. and issued a positive opinion. We think the European Commission decision will be positive.

Enrique A. Conterno: We don't expect the influence of the U.S. FDA's ADCOM on that decision. In terms of the next steps for regulatory affairs in Europe, I believe it's just waiting for that EC decision, and then that's the point in time when the product inserts are available. So that's, that's basically it.

Operator: We have no further questions at this time. I will now turn the call back to our presenters for closing remarks.

Enrique A. Conterno: Very well. I just want to once again thank everyone for participating. We very much appreciate your participation today on the investor call and your interest in FibroGen. Please enjoy the rest of your day. Thank you very much.

Operator: Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.

Operator: © BF-WATCH TV 2021 music music music music music music music music music music music music music music music music music music music music ?? ?? ?? ?? ??

Operator: Good day, and thanks for standing by. Welcome to the FibroGen 2nd Quarter 2021 Financial Results Conference Call.

Michael Tung: At this time, all participants are in listen-on-the-moon 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 star 1 on your telephone keypad. If you require any further assistance, please press star 0. As a reminder, this conference call is being recorded. I'd now like to turn the call over to Mr. Michael Tung. Please go ahead.

[music].

Michael Tung: Thank you, Charlie. Good afternoon, everyone, and welcome to FibroGen's 2021 second quarter conference call. I'm Michael Tung, Vice President of Corporate Strategy and Investor Relations at FibroGen. Joining me on today's call are Enrique Conterno, our Chief Executive Officer; Pat Cotroneo, our Chief Financial Officer; Dr. Mark Eisner, our Chief Medical Officer; Dr. John Hunter, our Chief Scientific Officer; Thane Wettig, our Chief Commercial Officer; and Chris Chung, our Senior Vice President of China Operations.

Michael Tung: The format for today's call includes prepared remarks from Enrique and Pat, after which we will open up the call for Q&A. I would like to remind you that remarks made on today's call may include forward-looking statements based on FibroGen's current expectations. Such statements may include statements regarding, but not limited to, our research and development activities, the initiation, enrollment, design, conduct, and results of clinical trials, our regulatory strategies and potential regulatory results, and anticipated FDA interactions.

Michael Tung: Commercialization and results of operations, risks, plans, market opportunities, and strategy related to our business, our collaborations with AstraZeneca and Astellas, financial guidance, and certain other business matters. Forward-looking statements are subject to significant risks and uncertainties that could cause actual results 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 in business, please refer to the disclosure in today's press release reporting our fiscal 2021 second quarter financial results in business.

Michael Tung: Our most recent forms 10-K and 10-Q, and reports that we may file on form 8-K with the Securities and Exchange Commission. All our statements are made as of today, August 9, 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. Today's press release reporting our fiscal 2021 second quarter financial results and a webcast of today's conference call can be found on the investor section of FibroGen's website at www.fibrogen.com. With that, I would like to turn the call over to Enrique Conterno, our CEO. Okay, Enrique?

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

[music].

Enrique A. Conterno: There is no question we are facing a significant challenge given the recent FDA Advisory Committee vote. However, FibroGen continues to be positioned to create significant value for patients and shareholders by executing on the three areas of focus as shown on slide three. Number one, ensuring regulatory and commercial success for Roxadustat, a transformation of medicine for the treatment of anemia, first in patients with chronic kidney disease and also with significant potential for expansion to the treatment of additional indications. Number two, developing pambrelumab in three indications with significant unmet medical needs, locally advanced and resectable pancreatic cancer, Duchenne muscular dystrophy, and idiopathic pulmonary fibrosis.

Good day and thank you for standby welcome to the price of Gen second quarter of 2021 financial results conference call at the time, all participants are in listen only mode. After the speaker's presentation. There will be a question and answer session to ask the question. During the session you will need to press the star 1 on your telling.

Keypad, if you require any produced distance. Please press star Zero as a reminder, this conference call is being the quality I'm not like to turn the call back to Mr. Michael Tung. Please go ahead.

Thank you Charlie good afternoon, everyone welcome to the <unk> 2021 second quarter conference call on Michael Tang Vice President of corporate strategy and Investor Relations at fibre channel.

Enrique A. Conterno: And number three, strengthening research productivity by leveraging our leadership position both in hypoxia-inducible factor and connective tissue growth factor biology and by accessing external innovation. Today's call will include an update on the regulatory status of Roxas Dustat, our continued strong performance in China, our clinical trial programs, and Recent Corporate Development. Let us get started with Broxa Dustan on slide four. In June, the CHMP of the European Medicines Agency adopted a positive opinion relating to the use of Roxadusta for the treatment of anemia associated with CKD. We expect them.

Joining me on today's call are of Richard can turn on our Chief Executive Officer, Pat Cotroneo, Our Chief Financial Officer, Dr. Mark is of our Chief Medical Officer, Dr. John Hunter, Our Chief Scientific Officer, Sandwort, Inc. Our Chief commercial officer, and Chris Chung, Our senior Vice President of China operations.

The format for today's call includes the prepared remarks from and regain Pat after which we will open up the call for Q&A I would like to remind you that remarks made on today's call may include forward looking statements based on 5 of <unk> current expectations. So.

Such statements May include statements regarding to but not limited to our research and development activities. The initiation of enrollment design conduct and results of clinical trials of regulatory strategies and potential regulatory results.

Anticipated FDA interactions.

Enrique A. Conterno: A decision from the European Commission by the end of August. In July, the FDA Cardiovascular and Renal Drugs Advisory Committee voted to recommend not approving Rofodustat for the treatment of anemia caused by CKD. We and our partner AstraZeneca are in dialogue with the FDA and expect an action in the near future. During the quarter, Roxasdusta was approved in South Korea to treat adult patients with anemia or CKD. And we have regulatory submissions in other territories under review to support commercialization efforts worldwide.

Commercialization of results of operations risks plans market opportunity and strategy related to our business on.

The collaborations with Astrazeneca, and Astellas financial guidance and certain other business matters.

We're looking statements are subject to significant risks and uncertainties that could cause actual results 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 and business. Please refer to the disclosure in today's press release reporting of our fiscal 2021 second quarter financial results and business update.

Our most recent forms 10-K and 10-Q.

Enrique A. Conterno: We have submitted manuscripts covering all Primary Phase III studies to peer-reviewed journals. As noted in slide 5, 70 of these manuscripts have been published, encompassing both non-dialysis-dependent and dialysis-dependent data. And we expect additional publications of the phase 3 data in the coming months. Moving now to China.

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

All of our statements are made as of today August 9.2021 based on information currently available to us in 5 or 10 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.

Enrique A. Conterno: As you can see on slide six, we are pleased to report total DusterNet sales to distributors in China of $52.8 million for the second quarter and $96.3 million for the first half of 2021. The increase in uptake continues to be driven by both an expansion in hospital listings and Broad Adoption with Enlisted Hospitals. FibroGen reported $13.4 million in China Roxadusta Net Product Revenue for the second quarter 2021 and $28.7 million for the first half of 2021.

Today's press release reporting of our fiscal 2021 of the second quarter financial results in the business update and a webcast of today's conference call can.

Can be found on the investors section of fiber to the website at www fiber to <unk> dot com with that I would like to turn the call over to Enrique Conterno, Our CEO every day.

Thank you, Mike and good afternoon, everyone and welcome to our second quarter 2021 earnings call.

Today, I would like to provide a high level summary of important accomplishments on developments in recent months.

That's good for now our CFO will then review the financials after which we will open up the call for your questions.

There is no question, we are facing a significant challenge given the recent FDA Advisory Committee vote.

Enrique A. Conterno: Hospital listings continue to be a key focus of our launch efforts, and at the end of the second quarter, Roxadista was listed in hospitals that collectively represent approximately 81% of the CKD anemia market opportunity in China, as you can see on slide seven.

However, fiber Gen continues to be positioned to create significant value for patients on shareholders.

By executing on the 3 areas of focus as shown on slide 3.

Number 1 ensuring regulatory and commercial success of rocks of the state.

Transformational medicine for the treatment of anemia.

Enrique A. Conterno: The ESA market growth has accelerated since the inclusion of Roxy Dustedt on the NRDL. In fact, ESA revenue over the last six months has shown meaningful growth over the same period in the prior year. Moving to slide eight.

The first in patients with chronic kidney disease, and also with significant potential for expansion of the treatment of additional indications.

2 developing from relative up in 3 indications with significant unmet medical need.

Locally advanced Unresectable pancreatic cancer.

Enrique A. Conterno: Roxasutha has driven the expansion of the anemia of CKD category over the past year and a half. In fact, Roxasutha captures 70% of the category growth and is gaining share in an expanding market. Finally... As shown on slide 9, Rocadustat has been the number one branded treatment for anemic CKD in China for the past five months, achieving a value share of 32% in the most recent month within the segment that includes all ESA products and refrigerants that are currently the only HIF-PHI in the market.

<unk> muscular dystrophy on idiopathic pulmonary fibrosis.

And number 3 is.

Strengthening research productivity.

By leveraging our leadership position both in hypoxia inducible factor and connective tissue growth factor biology on by accessing external innovation.

Today's call will include an update of the regulatory status of Brooks of distant.

Continued strong performance in China, our clinical trial programs on recent corporate developments.

Let us get started with Brooks had the <unk> on slide 4.

Enrique A. Conterno: We look forward to keeping you updated as we advance our long-term goal of making Roxy Dustedt the standard of care in treating China's TKD anemia patients. Moving now to our clinical development programs, slide 10, continues to create challenges for recruitment, and today we are updating our timelines, starting with Rocks at Dustan. We recently completed WHITNEY, our Phase II trial in patients with chemotherapy-induced anemia, and look forward to sharing top-line data with you later this quarter.

In June.

The <unk> of the European Medicines agency.

Adopted a positive opinion.

Relating to the use of Brooks of do still for the treatment of anemia associated with <unk>.

We expect a decision from the European Commission by the end of August.

In July.

The FDA cardiovascular and renal drugs Advisory committee voted to recommend not approving rocks the <unk> for the treatment of anemia of <unk>.

We on our partner Astrazeneca are in dialogue with the FDA.

I would expect the nextgen in the near future.

During the quarter. It looks at this time was approved in South Korea to treat adult patients with anemia of CTV.

And we have regulatory submissions in other territories under under review.

Yeah.

To support commercialization efforts worldwide.

Enrique A. Conterno: Top-line data from Matterhorn, a phase 3 trial in patients with anemia or myelodysplastic syndromes or MDS, is now expected in the second half of 2022 or first half of 2023, versus prior guidance for the first half of 2022. In China, the blinded portion of the Phase III trial of Roxas-Dooster in patients with anemia of MDS has begun enrollment. Moving now to the Pambrello Map, in locally advanced and resectable pancreatic cancer.

We have submitted manuscripts covering all primary phase III studies to peer review journals.

As noted in slide 5.

7 of these manuscripts have been published encompassing both non dialysis dependent on dialysis dependent data and we expect additional publications of the phase III data in the coming months.

Moving now to China.

As you kind of see on slide 6 we are pleased to report total looks at this the net sales to distributors in China of $52.8 million for the second quarter on.

$96.3 million for the first half of 2021.

Enrique A. Conterno: An interim analysis of event-free survival for potential accelerator approval of our LAPIS Phase III trial will be completed in the second half of 2022. Previously, the reflection rate was a surrogate endpoint for accelerated approval. After recent discussions with the FDA, we changed this endpoint to the event-free survival endpoint, which is composed of progression, death, and resection failure due to progression. This better reflects the potential clinical benefit in this patient population. During the second quarter, PAMRELUMA was included in the Pancreatic Cancer Action Network's Precision Promise adaptive trial platform, which is evaluating PAMRELUMA and standard of care for patients with metastatic pancreatic cancer. Moving to Duchenne muscular dystrophy, Rommel continues an Alelanthus-1 phase C trial in non-ambulatory patients, with top-line data now expected in the first half 2023 versus prior guidance of second half Finally, in idiopathic pulmonary fibrosis.

The increase in uptake continues to be driven by both on expansion and cost per of listings.

On broad adoption with enlist the hospitals.

Hydrogen reported $13.4 million in China of rocks at the start of net product revenue for the second quarter of 2021.

On to an $8.7 million for the first half of 2021.

Hospitalist sales continued to be a key focus of our launch efforts on at the end of the second quarter rocks at the start was listed as hospitals. The collectively represent approximately 81% of the CK the anemia market opportunity in China.

As you can see on slide 7.

The USA market growth has accelerated since the inclusion of Brooks reduce debt on the NRT the L.

In fact is the revenue over the last 6 months has shown meaningful growth over the same period in the prior year.

Moving to slide 8.

Because of the has driven the expansion of.

Of the anemia of CK the category over the past the year and a half.

In fact growth because its the capture 70% of the category growth and it's capturing share in an expanding market.

Finally.

As shown on slide 9 because the study is the number 1 branded treatment for anemia. She gave in China for the past 5 months.

Leaving our value share of 32% in the most recent months within the segment that includes all Esa products on Rofin Goose debt currently the only <unk> of China market.

Enrique A. Conterno: Today, we're pleased to provide guidance that we expect top-line data from our Cephris 1 Phase 3 trial in mid-2023. These timelines assume current COVID conditions, and we will provide further updates as they become available. Moving now to the corporate update, we appointed Dr. John Hunter to the position of Chief, scientific Moving now to slide 11, in June, we announced our partnership with HiFiBio to advance next generation therapies for patients with cancer and autoimmune disease, a deal which could enable up to three, I end this by 2023. FibroGen is accessing three new monoclonal antibodies against exciting targets, Galectin-9. CXCR5, and CCRA. Selecting 9 is an oncology target with a reported role in acute myeloid leukemia and immune resistance in many solid tumors.

We look forward to keeping you updated as we advance our long term goal of making the Brooklyn do set the standard of care in treating China's TK the anemia patients.

Moving now to our clinical development programs on slide 10.

Covid.

Continuous the grid challenges to recruitment and today, we are updating our timeline the starting with <unk>.

We recently completed the Whitney our phase II trial in patients with the chemotherapy induced anemia.

And look forward to sharing top line data with you later this quarter.

Top line data of Matterhorn, our phase III trial in patient with an email mill of dysplastic syndrome or Mds.

He is now expected in the second half of 2022 or first half of 2023.

Versus the prior guidance of the first half of 2022.

In China, the blinded portion of the phase III trial of rocks of the study in patients with anemia of MTS has begun enrollment.

Moving now to pan bread of them up.

In locally advanced and risk on Resectable pancreatic cancer.

On interim analysis of the event free survival for potential accelerated approval of our LAPIS phase III trial will be completed in the second half of 2022.

Enrique A. Conterno: Next, TXTR5, is an autoimmune and oncology target, and our primary interest is autoimmunity, but there are also opportunities in better cell lymphoma. Finally, CCRH is an oncology target with broad potential in solid tumors.

Previously the resection rate was the surrogate endpoint for accelerated approval.

At the recent discussions with the FDA, we changed this endpoint to the event free survival endpoint.

Which is composed of progression.

Enrique A. Conterno: Now I would like to provide an update on our internal review. On April 6, 2021, the company clarified that the certain previously disclosed cardiovascular safety analysis from the Roxas-Dustat Phase III program, for the treatment of anemic chronic kidney disease included post hoc changes to the certification factors, and provided additional data from the cardiovascular safety analysis with a pre-specified stratification factor.

Death.

On resection failure due to progression the.

This better reflects the potential clinical benefit in this patient population.

During the second quarter and read about what's included in the pancreatic cancer action networks precision promise adaptive trial platform, which is evaluating pound volume on <unk>.

<unk> of care for patients with metastatic pancreatic cancer.

Moving to Duchenne muscular dystrophy enrollment continues from Atlantis, 1 phase 3 trial in non ambulatory patients with.

Enrique A. Conterno: As stated at that time, the company initiated an internal review to ensure this did not occur in the future. We have now completed that review. Key company findings from the review are as follows. The underlying data used for the cardiovascular safety analysis are accurate, with no data integrity issues with the data used to generate such analysis. In its NDA, the company calculated accurately and described both sets of analysis, including the statistical, methodologies, and stratification factors utilized. The statistical analysis using post hoc stratification factors was designated as the primary analysis, and the statistical analysis using pre-specified stratification factors as the sensitivity analysis.

With top line data now expected in the first half of 2023 versus prior guidance of the second half 2022.

Finally in idiopathic pulmonary fibrosis.

Today, we're pleased to provide guidance that we expect top line data.

From our surface 1 phase III trial in mid 2023.

The silence assume current COVID-19 conditions.

And we will provide further updates a day of become available.

Moving now to the corporate update we appointed Dr. John Hunter to the position of Chief.

Scientific officer.

Moving now to slide 11 in June we announced our partnership with Hi Fi Bio the advanced next generation of therapies for patients with cancer and autoimmune disease.

Which could enable up to 3.

I end this by 2023.

Fibrogenesis accessing 3 new monoclonal antibodies.

Enrique A. Conterno: Those responsible for the statistical analysis believed it was a reasonable and valid way to analyze and present the data. Management is taking steps to ensure the company's processes are consistent with best practices in all respects. In addition to other processes and procedures... We plan to implement independent quality unity oversight of clinical data management, programming, analysis, and reporting. Furthermore, those directly responsible for the decision to use post-hoc electrification factors in the primary analysis... no longer work for the company.

The exciting targets collecting 9.

<unk> 5 on CCR right.

Now, let the 19th in oncology targets with the reported ROE in the acute myeloid leukemia and immune resistance in many solid tumors.

Next Dx share 5 is on our immune oncology target on a primary injuries or immunity.

But there are also opportunities.

In Brazil lymphomas.

Finally, <unk> is on oncology target.

With broad potential in solid tumors.

Now I would like to provide an update on our internal review.

On April 6.2021, the company clarified.

The certain previously disclosed cardiovascular safety analysis.

From the rocks are those the phase III program for.

For the treatment of anemia in chronic kidney disease included.

Enrique A. Conterno: The use of post hoc certification factors was not discussed by the FDA Advisory Committee, a reference as a consideration that led to the Advisory Committee vote against recommending approval for Roxas Ducey. We do not believe that it played any role in that vote.

Both of changes to the stratification factors and.

And provided additional data from the cardiovascular safety analysis with the Prespecified stratification factors.

As stated at the time the company initiated an internal review to ensure this does not occur in the future.

We now have completed the review.

The company findings from the review of as follows.

Pat Cotroneo: I will now turn the call over to our CFO, Pat Cotroneo, for the financial update. Thank you, Enrique. As announced today, total revenue for the second quarter of 2021 was $24.4 million, as compared to $42.9 million for the second quarter of 2020. The current quarter revenue consists of $13.4 million. Net product revenue for Roxadustat sales in China. $19.6 million in development revenue, and a negative $8.6 million in drug product revenue, which reflects our estimate of lower potential revenue from commercial batches shipped to date to AstraZeneca in the U.S. as a result of the recent unfavorable advisory committee, for the same period, operating costs and expenses, were $158.2 million and net loss was $134 million or $1.45 per basic and diluted share, as compared to operating costs and expenses of $128 million and a net loss of $85.3 million or $0.95 per basic and diluted share for the second quarter last year, included in operating costs and expenses, for the quarter ended June 30, 2021, was a one-time charge of $25 million related to our partnership with HiFiBio, and an increase of approximately $20 million, which is primarily in Pemrevlu map development expenses, as compared to the second quarter last year. Operating costs and expenses for the quarter also included a non-cash charge of $19 million for stock-based compensation expenses, as compared to $17.6 million for stock-based compensation expense for the same period in the prior year.

The underlying data used for the cardiovascular safety analysis are accurate with no data integrity issues with the data used to generate such analysis.

In its NDA the company calculated accurately and described both set of analysis.

Including the statistical methodologies on the stratification factors utilized.

The statistical analysis using post hoc stratification factors.

The designated as the primary analysis.

On the statistical analysis, using Prespecified stratification factor is the sensitivity analysis.

Those responsible for the statistical analysis.

Believed it was a reasonable on valued way to analyze and present the data.

Management is taking steps to ensure the company's processes are consistent.

With best practices in all respects.

In addition to other processes and procedures, we plan to implement independent quality unity oversight of clinical data management programming analysis on reporting.

Furthermore, the directly response, so far the decision to use post hoc stratification factors in the primary analysis no longer work for the company.

The use of post hoc certification of factors was not discussed by the FDA Advisory Committee of references of consideration the led.

The the advisory committee vote against the recommending approval for rux reduced debt.

We do not believe that it played any role in that vote.

I will now turn the call over to our CFO barcode for now for the financial update Pat.

Thank you Enrique as announced today total revenue for the second quarter of 2021 was $24.4 million as compared to $42.9 million for the second quarter of 2020.

The current quarter revenue consists of $13.4 million net product revenue for <unk> sales in China.

$19.6 million in development revenue.

And the negative $8.6 million in drug product revenue, which reflects our estimate of the lower potential revenue from commercial batches shipped to date to astrazeneca in the U S. As a result of the recent unfavorable of Advisory Committee balance.

For the same period operating costs and expenses were $158.2 million and net loss was $134 million or $1.45 per basic and diluted share.

Pat Cotroneo: At June 30, FibroGen had $640.5 million in cash, cash equivalents, restricted time deposits, investments, and receivables. As we have previously disclosed, starting the first quarter of 2021, the jointly owned distribution entity between AZ and FibroGen or the JDE began selling Roxodustat to distributors and paying for AstraZeneca's commercialization efforts in China and AZ's portion of the profit. Previously, FibroGen was responsible for these items to provide context for the operating results of our Roxa DoStat business in China.

As compared to operating costs and expenses of $128 million and the net loss of $85.3 million or <unk> 95 per basic and diluted share for the second quarter last year.

Included in operating costs and expenses for the quarter ended June 32021 was a 1 time charge of $25 million.

Weighted to our partnership with high 5 buyout.

And an increase of approximately $20 million, which is primarily in perm revenue map development expenses.

As compared to the second quarter of last year.

Operating costs and expenses for the quarter also included a noncash charge of $19 million for stock based compensation expense as compared to $17.6 million of course.

Pat Cotroneo: Total rocks-a-deuce that net sale, including sales through the JDE to its distributors and FibroGen China's direct sales to our distributors, was $52.8 million for the second quarter of 2021. The JDE accounted for over 97% of the total Chinese Roxadustat sales volume. Our net transfer price from sales to the JDE was $17.1 million for the second quarter, which is within the 30 to 45 percent range of the JDE's Roxadustat net sales to which we previously guided.

GAAP based compensation expense for the same period in the prior year.

At June 35 per Jim had 640 <unk> 5.

$5 million on cash cash equivalents.

The time deposits investments and receivables.

As we have previously disclosed starting the first quarter of 2021 the <unk>.

Jointly owned distribution entity.

Between AZ and fibre channel or the J D. E began selling lots of new stat to distributors and pain for Astrazeneca commercialization efforts in China and any of these portion of the profit share.

Previously fiber Jim was responsible for these items.

Pat Cotroneo: After the net transfer price is determined, we defer a certain portion of such net transfer price for revenue recognition purposes under U.S. GAAP. As a result, FibroGen reported $13.4 million in China Roxaduce.net product revenue for the second quarter of 2021. This amount also includes FibroGen's adjusted net transfer price of $11.7 million from sales to JDE and the balance consisting of our direct sales to Chinese distributors in China. Looking ahead at our broader financial picture, we have a total of $120 million in potential milestones expected for anticipated EU approval for DD and NDD by year-end.

To provide context for the operating results of our lots of <unk> business in China.

Total lots of do stat, net sales, including sales through the JV to its distributors.

And fiber in China is direct sales to our distributors was $52.8 million from the second quarter 2021.

The JD accounted for over 97% of the total China rocks do stat sales volume.

Our net transfer price from sales to the JV was $17.1 million for the second quarter.

Which is within the 30% to 45% range of the JD ease of rocks reduce debt net sales to which we previously guidance.

After the net transfer price is determined we defer a certain portion of such net transfer price for revenue recognition purposes under U S. GAAP.

As a result, Pyrogen reported $13.4 million in China rocks reduced debt net product revenue for the second quarter 2021.

Pat Cotroneo: Based on our latest forecast, we estimate our 2021 ending balance of cash, cash equivalents, restricted time deposits, investments, and receivables to be in the range of $480 to $490 million, assuming EU rocks reduce that approval in 2021. Thank you. And I would now like to turn the call back over to Enrique. Thank you, Pat, and in closing... Rock Seduced continues to perform very well in China.

This amount also includes fiber Jens adjusted net transfer price of $11.7 million from sales to the J D E and the balance consisting of our direct sales to China distributors in China.

Looking ahead at our broader financial picture, we have a total of $120 million in potential milestones expected for anticipated EU approval in Didi and <unk> by year end.

Based on our latest forecast, we estimate our 2021 ending balance of cash cash equivalents restricted time deposits investments and receivables to be in the range of 480 to 400 of $90 million.

Assuming EU walks of juice that approval in 2021.

Enrique A. Conterno: We expect a decision in Europe by the end of August, and we have multiple regulatory submissions under review in other geographies. PAMRELUVA is a potential first-in-class medicine and is in Phase III development for three indications with significant unmet medical need, locally advanced and resectable pancreatic cancer, sheen muscular dystrophy, and idiopathic pulmonary fibrosis. Finally, we continue to advance our research agenda by advancing our internal candidates and accessing external innovation like the HiFiBio deal.

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

Thank you passed on in closing.

<unk> continues to perform very well in China.

We expect the decision in.

In Europe by the end of August and.

And we have multiple regulatory submission under review in other geographies.

On relative or with a potential first in class medicine in phase III development in 3 indications with significant unmet medical need locally advanced unresectable pancreatic cancer and Duchenne muscular dystrophy.

The party pulmonary fibrosis.

Finally, we continue to advance the research agenda by advancing our internal candidates and assessing the external innovation like the HIFU of biodiesel.

Enrique A. Conterno: As shown on slide 12, we continue to have a strong financial position, with approximately $641 million in cash and another 120 million dollars in anticipated RoxaDusta milestone payments. Expect it during 2021, assuming EU approval later this year. Now, I would like to turn the call back to the operator for questions.

As shown on slide 12, we continue to have a strong financial position.

With approximately $641 million in cash and another $120 million.

And anticipated <unk> of do some milestone payments expected during 2021, assuming EU approval later this year.

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

Operator: As a reminder, if you have a question at this time, please press star then the number one key on your touchtone telephone. If your question has been answered or you wish to remove yourself from the queue, press the pound key. Please limit your question to one and one follow-up. Your first question comes from the line of Michael Yee with Jeffries. Your line is now open.

As a reminder, if you had the question at this time please.

Star then the number 1 key on your Touchtone telephone. If your question has been answered or you wish to and the yourself from the queue price per pound key. Please limit your question to 1.1 follow on.

Your first question comes from the line Michael Lee The Jefferies. Your line is now open.

Michael Jonathan Yee: Hi, thanks. Good afternoon, Enrique. We just wanted to ask you about how to think about the upcoming next steps after whatever happens.

Hi, Thanks, good afternoon Enrique.

Just wanted to ask you about how to think about the upcoming <unk>.

Next steps after whatever FDA decision comes I mean, I think it's safe to say that the market has changed a negative decision and if that's the case how should we expect the ongoing partnership with Astrazeneca to progress and are you having discussions that would include all options on the table and maybe just talk to that.

Michael Jonathan Yee: After whatever FDA decision comes, I think it's safe to say that the market assumes a negative decision, and if that's the case, how should we expect the ongoing partnership with AstraZeneca to progress, and are you having discussions that would include all options on the table? Maybe just talk about that, because I think that that's what people are trying to figure out with the next step in the U.S.

I think that that's what people are trying to figure out what the next step the pea in the U S. Thank you.

Enrique A. Conterno: Yeah, clearly, I want to ensure that we don't get ahead of any FDA action. But clearly, you have to assume that we're planning on all scenarios here. And it's going to, of course, be based on our discussions, and we've had some discussions with both the FDA and AstraZeneca. We need to, we've been working basically to try to understand a potential path forward here. We expect a decision.

Yes clearly.

I want to ensure the we don't get ahead of.

Any FDA action.

But clearly you you have to assume that we're planning on or.

The scenarios here.

Is going to of course based on our discussions.

We've had some discussion with both.

The FDA and Astra.

Astrazeneca.

We need to we've been working basically to try to understand.

On a potential pass.

Forward here.

We expect a decision I think it's difficult to say, we have not been given a.

Enrique A. Conterno: We have not been given a timeline for that, but I think you will witness the outcome just like we did. Of course, we were quite disappointed and surprised by the vote and how that discussion turned out and the final outcome of the vote. Clearly, under a scenario of a complete response letter, we'll need to see what the details are for that complete response letter and make decisions appropriately, but there's no question that under any of those scenarios, we will have to make a significant reallocation of resources and corresponding reduction in expenses with that.

Timeline for that but I think you know you witness the outcome of just like we did.

Of course, we were quite disappointed on.

The surprised with the.

With the vote, the how debt discussion turn out on the final outcome of the vote.

Clearly under a scenario of a complete response letter will need to see what the details are for the complete response letter.

And make decisions appropriately but theres.

There is no question on there or any of the scenarios, we will have to make significant relocation of resources and on.

The corresponding.

Reduction in expenses with that.

Enrique A. Conterno: As I mentioned, we are expecting a decision in Europe by the end of this month, so we are excited about that. I don't know, Mark, if you want to make any additional comments. No, thanks, Enrique. I think you summarized it well. We're working collaboratively with FDA and AstraZeneca to find the path forward, and we await the FDA's decision and next steps.

As I mentioned.

You mentioned.

We.

Expecting a decision in Europe.

By the end of this.

On a month. So we are excited about that I don't know Mark if you want to make any additional comments.

Yeah, I think you summarized it well I mean, we're working collaboratively collaboratively with FDA and Astrazeneca to find the path forward and we await the fda's decision and.

And next steps.

Operator: Your next question comes from the line of Annabel Samimy with STFL. Your line is now open.

Thank you.

Your next question comes from the line of animal Sydney.

Your line channel.

Annabel Eva Samimy: Hi, thanks for taking my questions. I apologize if I missed the initial comments, but maybe you can, you know, sort of... talk to us about the chemotherapy-induced anemia studies. I saw that they were completed on clinicaltrials.gov. Can you tell us when and what form that data might be reporting out, and is there anything that you can pull from these studies that might help you address some of the issues that you came across in the? in the dialysis or the non-dialysis CKD studies. And yeah, that's essentially my question. I'll wait for them to follow up with my own.

Hi, Thanks for.

Taking my questions and.

I apologize if I missed the initial comments.

But maybe you can.

Sort of.

Talk to us about the chemotherapy induced anemia studies.

They're completely on clinical trials Gov.

Can you tell us what in what form of that data might be reporting out and is there anything that you can pull from these studies that might help you addressed some of the issues that you came across in the.

In the dialysis and the non dialysis.

These studies.

And.

Yeah.

That's essentially my question I'll wait away.

Away from the pit follow up with that.

So.

Hum.

Enrique A. Conterno: So we've really finalized the phase two study for chemo-induced anemia, and at this point in time, we're expecting to report top-line data imminently. I'm going to ask Mark Eisner to provide some more color on whether any of this data can help any type of discussion with the FDA or how we think about this. So thanks. It's an interesting question.

Really finalized debt the.

The phase 2 study for chemo induced anemia.

And.

At this point in time, we're expecting to report top line data.

Imminently I'm going to ask maybe mark Eisner to provide some more color on whether any of these data can help.

Any type of discussion with the EBITDA on.

How do we think about these data.

So thanks, it's it's an interesting question I think the short answer is no I mean chemotherapy induced anemia, and <unk> are very different indications very different patient populations. So I don't see CIA informing the CK D decision or the the assessment there.

Mark Eisner: I think the short answer is no. I mean, chemotherapy-induced anemia and CKD are very different indications, very different patient populations, so I don't see CIA informing the CKD decision or the assessment there. That said, we're looking forward to seeing the top-line data, the Phase II data, and looking forward to sharing those shortly and thinking about what the pathway could be for CIA as an indication.

That said, we feel we're looking forward to the to see the top line data of the phase 2 data.

The forward to sharing knows shortly and thinking about what the pathway could be for CIA is as an indication.

Annabel Eva Samimy: I'm going to ask you, obviously, it was clear from the panel that the physicians want to see a titration study, not a simulated modeling study of what titration can do. Given that these thrombotic events occur earlier in treatment, do you think that a titration study would be relatively short? Is this something that could be conducted rapidly, or am I thinking about this incorrectly?

Okay great.

Great and if I could just ask on.

Obviously, it was clear from some of the panel of the debt.

Yeah.

The physicians want to see.

On the titration study not a.

Stimulated modeling study of what cash.

You can do.

Given that these thrombotic events occur earlier in treatment.

Inc.

Titration study would be relatively short.

Is this something that can be conducted rapidly.

Alright, my thinking about this incorrectly.

Mark Eisner: Thanks for the question. Just to start out to say that, you know, we believe that the benefit-risk profile of roxidustat for the treatment of CKD anemia in both the NDD and DD populations is favorable with the dosing regimen that we studied in Phase 3. But we did collaborate with FDA on some analyses, as you know, looking at the rate of rise of hemoglobin and the relationship with thrombotic events. And we do believe that starting at a lower starting dose of roxidustat and titrating up would be a very reasonable approach to treating patients and mitigating the risk.

Mark.

Thanks for the question.

Just to start out to say the we believe that the benefit risk of rocks reduce debt for the treatment of CK day anemia, and both of the NTT and Didi populations as is favorable with the dosing regimen that we started in phase III, but we did collaborate with FDA on to the analyses as you know looking at rate of rise of he.

Globe and the relationship with thrombotic events and.

We do believe that starting at a lower starting dose of <unk> and tight trading up would be a very reasonable approach to treating patients in mitigating the risk. We actually don't believe another trial is needed to prove the hypothesis, it's well established in the Esa field over the last 2 or 3 decades.

Mark Eisner: We actually don't believe another trial is needed to prove that hypothesis. It's well-established in the ESA field over the last two or three decades. And, you know, we think the same applies with roxidustat. In terms of what study the FDA may or may not ask us to do, this remains an open question. And it's difficult to speculate right now, and we're just waiting for input. Here's your next question.

And we think the same applies with rocks do stop.

In terms of what study the FDA may or May not ask us to do this remains an open question and I think it's difficult to speculate right now and we are just waiting for it.

Input from the agency on that.

Operator: Your next question comes from the line of Job Free 4G's RID SBB Larynx. Your line is now open. Pardon me, Mr. Corgis, your line is now closed.

Your next question comes from the line of the choppy for mid SBB Leerink. Your line is now open.

Operator: Thank you very much. Apologies; I was on mute. Could you tell us whether there's been any correspondence from the EMA since the Adcom requesting additional information or analysis, or is the file that you originally submitted the only information you've been asked to provide?

Thank you very much apologies I was on mute I was just.

Wondering could you tell us whether there's been any correspondence from the EMA.

The AD com requesting additional information or analysis.

Or is the file that you originally submitted on beer.

On the information you've been asked to provide and.

Operator: And then, secondly, just in terms of the expenses.

And then secondly.

Just in terms of the expenses.

Operator: I think by the end of the year, it looks like you'll have about $470 million in cash. And you had a burn rate this quarter of $134 million. I know there were one-time items in that burn rate, but it looks as though by the end of the year, you might have a year to a year and a half of cash left. What are the options you have to significantly reduce the company's cash burn so that you don't need to refinance the company at this greatly impaired valuation level? Thanks.

I think by the end of the year. It looks like you have about 460 of $470 million of net cash.

On the burn rate this quarter of $134 million.

There were 1 time items in that burn rate, but.

It looks as though by the end of the EBITDA you might have a year to year on half of cash left.

What are the options you have the significantly reducing the company's cash burn so that you don't need to refinance the company at this greatly impaired valuation level. Thanks.

Mark Eisner: Mark, do you want to discuss the first part of the question? I'll discuss the burn rate. Sure. So the question is, since the ADCOMM, has there been any communication from or to EMA? The answer, to my knowledge, is no; there's been none.

Yes.

Mark do you want to discuss the first part of the question and I will discuss the burn rate sure. So the question is since YOD com has there been any communication from or to EMEA answer to my knowledge. There's no. There's been on and we don't anticipate any impact on the European Commission decision in August.

Enrique A. Conterno: And we don't anticipate any impact on the European Commission decision in August. On your question about the burn rate, first, I think we have no intention of raising money. I think we have, as I mentioned, a number of scenarios that we're working on. Clearly, under a scenario of a complete response letter, we would need to basically reassess our priorities and reallocate our resources and significantly decrease expenses. There are a number of plans that we have to ensure that we can... deliver value for shareholders.

Great great.

Yeah on the.

Your question about the burn rate.

We first I think of it we have no intention of raising money I think we have.

You mentioned the number of scenarios that we're working on clearly under a scenario of a complete response letter we would.

Need to.

Basically we are.

Reassess our priorities on.

We allocate our resources on significantly decrease expenses.

There are a number of plants that we have to ensure that we can.

Deliver value for shareholders.

Enrique A. Conterno: And clearly, under this scenario, yes, we do have Rokta D'Usta in China in a number of markets. And keep in mind that China is now basically profitable. We are reimbursed for any expenses, so we do not have any... And, of course, we need to ensure that we can get to the readouts of the PAMBREVLU map as soon as possible. So that's priority one. But yeah, there's no question that we have to ensure that we are going to be able to basically bridge for us to be able to see the data and be able to launch the PAMBREVLU map.

On clearly under the scenario, yes, we do have the do set in China and a number of markets.

And keep in mind, the Chinese now basically profitable on.

In the rest of the markets, we do not.

We are reimbursed for any expenses. So we do not have any expenses when it comes to both commercial and development expenses, we will be getting a royalty.

And of course, we need to ensure the we can get to the readouts of umbrella them up.

Soon as possible so that's the.

Priority 1.

But yes. There is there is no question the we don't.

The we have to.

Ensure that we are going to be able to.

Basically bridge for us to be able to.

See the data and be able to launch of umbrella.

Alright, thank you.

Operator: Your next question comes from the line of Edwin Zhang with HC Wainwright. Your Line is now Hi, thanks for taking my question. On China revenue, can you help us understand why the net ROXA revenue that FibroGen booked this quarter was 2 million less than last quarter, while the total net revenue and hospital listings were actually both increasing? Also, do you expect any rupture pricing pressure in the coming era?

Your next question comes from the line of Edwin Zhang from H C. Wainwright. Your line is now open.

Hi, Thanks for taking my question.

On finally revenue can you on.

And why the net revenue that's of fiber to books this quarter was true meaning less than last quarter, while the total net revenue on the hospital listings will actually both increasing.

Also do you expect on the Iraq the price the pressure the Colombian upcoming.

Edwin Zhang: NRDL negotiation in China, and then I have a follow-up.

The <unk> negotiation in China, and then the have a follow up.

Enrique A. Conterno: Yeah, I'm gonna ask maybe Pat to comment on the first question on net revenue, FibroGen booked a million less while the overall sales to distributors basically continued to increase. By the way, of course, we see the overall net sales to distributors as really the fundamentals of the business and one thing to be able to look at. The NRDL and what are our expectations.

Yes, I'm going to ask maybe.

<unk> to comment on the.

The first question on the net revenue.

On the fiber to the booked 2 million less of while the.

Overall sales to distributors of basically continuing to increase by the way of course, we see the overall net sales to distributors.

<unk> really the.

The fundamentals of the business and 1 thing to be able to look at.

Pat Cotroneo: Thank you, Enrique, and thank you for the question. You know, to start, just as a reminder, as I mentioned in my prepared remarks, we have deferred revenue. And this is due to adjustments to our net transfer price to reflect U.S. GAAP. These adjustments are required for accounting purposes because we have manufacturing and supply obligations to the JDE over an estimated performance period. So what you're seeing here is just a deferral of a portion of the revenue to the latter year.

We will have Pat Cotroneo, our CFO address that question and then we'll have Chris talk.

About.

The <unk> on what are our expectations there.

Thank you and thank you for the question Yeah of course.

Just just as a reminder is that as I mentioned on my prepared remarks.

We have deferred revenue.

And this is from adjustments of our net transfer price to reflect U S. GAAP.

These adjustments are required for accounting purposes, because we have manufacturing and supply obligations to the J D.

Over an estimated performance period, so what you're seeing here is just the deferral of a portion of the revenue the latter years.

Pat Cotroneo: And, and, you know, accordingly, we deferred $3.9 million in Q1 of 2021 and then approximately $5.4 million in Q2 of 2021. So this is strictly related to performance obligations and, and, and the gap requirements under Revenue Recognition.

And and.

As accordingly, we deferred 3.9 million on Q1 of 2021 and then the.

Approximately 5.4 million on Q2 of 2021.

This is strictly related to our performance obligations and the GAAP requirements under revenue recognition of homes.

Christine L. Chung: Chris? Chris?

Chris Chris.

Can you comment on the <unk>.

Christine L. Chung: Absolutely, Enrique. So with regard to NRDL, as to the question of whether there will be a change in pricing starting next year, the answer is yes, per the rules of NRDL every single two years. The price is renegotiated. As you know, last time we entered NRDL on January 1st, 2020, and we will have a new price for 2022, January 1st. The direction of these negotiations is always downward, so it's not a question of whether or not, but how much. There is a very well-established process in terms of how prices are determined.

Absolutely Enrique.

So with regard to end RTL as to the question of whether there'll be a change in pricing starting next year. The answer is yes per.

The rules of <unk> and we can go 2 years.

The price is renegotiated as you know last time, we entered and LDL in January 1st 2020, and we will have on your price for 2022 January 1st of.

The direction of these negotiations is always downward so it's not a question of weather, but how much.

There is a very well established process in terms of how prices are determined is tepid.

Christine L. Chung: And we stand behind the clinical value demonstrated by ROCKCD's debt, and as you have seen in the very strong sales in the last couple quarters.

Based on clinical value and we stand behind the clinical value of demonstrated by rock city of Scott and.

As you've seen in the very kind of sales on the last couple of quarters. We ask the very strong key opinion leader support from clinical key opinion leaders pharmacology of sand pharmacies.

Christine L. Chung: We also have very strong support from clinical Key Opinion Leaders.

Minnery ex fiber.

The fiber to the investors and I believe that we're uniquely positioned as an innovative drug to deliver value not just to patients but to the health care system. So we remain optimistic in terms of of what the pricing outcome might look like in Q4.

Christine L. Chung: and opinion leaders, pharmacologists, and pharmacies.

Christine L. Chung: Finally, FibroGen and AstraZeneca believe that we're uniquely positioned as an innovator.

Operator: Great. I have a follow-up question on the U.S. I was also wondering, what's your future plan for Roxa in CKD anemia in the U.S.? Are you willing to do additional safety studies and prepare for resubmission some years later? Or would you rather drop the CKD anemia indication in the U.S., assuming Roxa won't receive FDA approval? Thank you.

Yeah.

Great well have a full up on the U S.

I was also wondering what your future plan on rocks the anemia in the U S.

Are you willing to do additional safety studies and prepare for the Resubmission on some years later or would you rather dropped the CTD of anemia indication in the U.

Assuming the rocks the once.

Once we receive FDA approval.

Operator: Yeah, as we mentioned, we don't want to speculate on the action by the FDA, and of course, if we were to get a complete response letter, what would be the terms of that complete response letter? So it's difficult to comment on your question without having the action and any potential specifics.

You.

Yeah, as we mentioned, we don't want to speculate.

On the action by the FDA and of course.

If we were to get a complete response letter what would be the terms of the complete response letter. So it's difficult to comment on your question without having the action on any potential of specifics there.

Your next question comes from the line up Yaron Werber Cowen Your line is now open.

Operator: Your next question comes from the line at P.R.N. Werber with Calwin. Your line is now open.

Operator: Great, thanks for taking my questions. I have a couple of questions that are interrelated, Enrique, if I can. The first one is just given the valuation...

Great. Thanks for.

Taking my questions I have a couple of questions that are interrelated to the replay if I can the first 1 just given the valuations in China right now on companies in China that are dual listed are listing in Hong Kong has there ever been of discussion to see whether you should spin out the China sub into its own independent company and sort of you're right. The valuations there and then secondly.

Operator: [inaudible]

Operator: And then secondly, depending on which way FDA goes here, from something small to a whole new study.

The depending on which way FDA goes here from something small to a whole new study in the much more complicated development path in case, the AZN decides that this might not fitting with our strategy can day exit the partnership in the U S. But remain intact with the on China or is it all of 1 size fits all thank you.

Operator: development path, and in case AZN decides that this might not fit in with their strategy, can they exit the partnership in the U.S. or remain in China?

Operator: Thank you. Yeah

Enrique A. Conterno: Yeah, clearly, when it comes to China, we think that we have a meaningful business in China and meaningful capabilities, as shown by the type of results and performance that we're basically getting there. And yeah, we're looking at, and we've looked at all options, and we're looking at all options in China to ensure that the value that we have there is basically better reflected in our share price. So that's, that's, that's something that we are very much looking into.

Yeah, clearly when it comes to China, We think the we have a meaningful business in China on meaningful capabilities of shown by.

The type of results and performance that were basically getting there.

Yes, we're looking at the and we've looked at all options on we're looking at all options in China to ensure that.

The value that we have there is basically better reflected on on our share Bryan so.

That's the assumption that we are very much looking at.

When it comes to the partnership.

Enrique A. Conterno: When it comes to the partnership, the partnership with both Stellas and AstraZeneca is, uh, very collaborative at this stage despite the very negative outcome of the adcom that we had at the U.N. And I expect that that's going to continue to be the case. We clearly want to see FDA action. And we do have additional indications that we're pursuing. But keep in mind that MDS is. It's a phase three trial ongoing, and we are about to see the CIA data. And, of course, based on that underlying data, we will. How do we proceed with that?

The partnership with the both the Astellas and Astrazeneca is.

A very collaborative at this stage despite the very negative outcome of the outcome that we've had in the U S.

And I expect that that's going to continue to be the case, we clearly went on.

Hum.

See the FDA action.

Hum.

And we do have additional indications on what percent of keep in mind that the Mds is is the phase III trial ongoing and we are about to see the data.

And of course based on.

That underlying data we will be.

Making the decision about how do we.

Operator: Your next question comes from the line at Andy Eshe with William Blair. Your line is now open.

Proceed with that indication.

Yeah.

Your next question comes from the line of Andy <unk> with William Blair. Your line is now.

Operator: Oh, great. Thanks for taking my question. So, you know, one of the take-home messages from the adcom is that there is tremendous, you know, interest from the physician community about the hypo responders. So, you know, I'm not asking about, you know, making projections, but I want to understand the collaboration framework. So, let's say hypothetically, if the parties decide to go forward with that, you know, study

Oh, great. Thanks for taking my question. So what are the take home messages from the AD Com is that there is tremendous.

And the interest from the physician community about the hypo responders so.

The asking about making projections, but I wanted to understand the collaboration framework, So let's say hypothetically.

If the parties decided to go forward with that debt.

Study.

Operator: How is the decision being made? Is there a joint steering committee?

How is the decision being made is there like a joint steering committee.

Operator: Steering Committee across the three companies to make a go and no-go decision. And then also, I guess from a financial perspective, is there additional cost from the FibroGen company? And then also, I guess from a financial perspective, is there additional cost from FibroGen.

Across the 3 company to make a go or no go decision and then also I guess from the financial perspective.

Is there additional cost from the fiber Jane.

Standpoint on on R&D or you have.

Operator: you know the standpoint on R&D, or you have already hit the limit.

Already hit the limit.

Operator: Yeah, and then the second question I have for Chris, you know, looking at slide number eight. You know, it seems like the ESA market in China is growing, and then, you know

Yes, and then the second question I have for Chris.

Looking at slide number 8.

It seems like the USA market in China.

Is is growing and then it seems like you are basically growing both the Esa and obviously the rocket the side I'm. Just curious if you can comment on the dynamic are you kind of growing the market or is there also some element of switching from from Esa.

Operator: It seems like, you know, you're basically growing both the ESA and, obviously, the Roxas v. Fed. I'm just curious, you know, if you can comment on the dynamic. Are you kind of growing?

Enrique A. Conterno: Are you kind of growing the market, or is there also some element of switching from ESA? Thank you. Maybe just let me try to address the question about FibroGen's expenses when it comes to commercial or development expenses for RoxyDustat. As I mentioned, outside of China, we have no expenses related to RoxyDustat, either on the commercial or development side.

<unk>.

Yes.

Maybe just let me try to address the question about.

<unk> expenses when it comes to.

The commercial or development expenses for <unk> as I mentioned outside of China. We have no expenses related to rux of do start either on the commercial or the development side.

Enrique A. Conterno: So we are fully reimbursed, and that would be the case as well if we were to pursue additional trials. I'm going to ask Mark to comment on the governance that we have, how decisions are made when it comes to additional trials. In particular, I think there was this question about trials in ESA hyper-responders. Mark?

So we are fully reimbursed and that would be the case as well if we were to pursue additional trials.

I'm going to ask Mark to comment on.

The governance that we have how is the Howard decisions made.

When it comes to additional trials.

In particular I think there was this.

Question about trials in east the Hypo responders Mark Alright, so the use of hyper responder group I mean, you're quite right. Several members of the Advisory Committee.

Mark Eisner: Right. So, the ESA hyper-responder group, I mean, you're quite right. Several members of the advisory committee noted that this was a high unmet need for patients and were intrigued by our data, both in patients with high systemic inflammation and functional iron deficiency, that actually, we have some data that do suggest Roxas2 stat is effective in ESA hyper-responders. If we were to embark on another trial, it would be a joint decision between FibroGen and AstraZeneca and FibroGen and As

Noted that the high unmet need for patients and we're intrigued by our data both in patients with high systemic inflammation and functional iron deficiency, the actually we have.

Some data the do suggest rocks to start is effective in use of hyper responders. If we were true embark on another trial it would be a joint decision between fiber Jane and Astrazeneca and fiber Jane and Astellas I mean, we of joint steering committee governance of the higher level and we have governance set of more team level.

Mark Eisner: I mean, we have joint steering committee governance at the higher level, and we have governance at a more team level with both companies, and we aim to... that is good for the tripartite and that everyone is aligned on. So we do have. Good governance procedures in place, highly collaborative relationships with both companies, and once we know what the FDA's expectations are, we'll be in a good position to. And Chris, if you could comment on Roxa and China, whether it's just growing the market, or it's also there, capturing new patients versus just switching, I don't know if you could provide some additional color on that.

On both with both companies and we aim to make decisions that are good for the tripartite.

Everyone is aligned on so we do have.

Good governance procedures in place highly collaborative relationships with both companies.

Once we know what the Fda's expectations are on will be in a good position to move forward.

And Chris if you could comment on.

<unk>.

In China, whether it's just growing the market or the social there's just sort of capturing new patients versus just the switching I don't know I don't know if you could provide some additional color to that.

Mark Eisner: Absolutely, Enrique.

Absolutely Enrique so the answer to the question is it is both.

Christine L. Chung: So the answer to the question is it is both. The category of ESA and HIF together in the class of anemia treating agents is growing.

The category of Isa and.

Together in the class of anemia treating agents it's growing.

Christine L. Chung: It's growing because there is increased awareness of the importance of treating the disease. The class share of HIF is also growing, and we are seeing conversion of patients from EISNER to HIF. Your next question comes from the line of... My apologies.

It's growing because there is increased awareness of the importance of treating the disease.

The class share of his is also growing and we are seeing conversion of patients from the east.

Your next question kind of from the line of.

My apologies.

Operator: Your next question comes from the line of... My apologies, ma'am. Just keep going. Charlie, you can keep going.

Just keep going.

Charlie you can keep going thank.

Thank you Sir your next question comes from the line of DPA Yang Mizuho. Your line is name of the.

Hi, good afternoon, Thanks for taking my question.

I'm just curious how do the Chinese doctors react too clearly split the opinion between.

Operator: Hi, good afternoon, and thanks for taking my question. I'm just curious, how do the Chinese doctors react to this clearly...

The EU regulatory agency.

Enrique A. Conterno: Do you expect this discrepancy will eventually lead to some changes in the demand for Roxa in China?

And do you expect.

I'm just grabbing the seawell.

<unk>.

Changes in the.

Demand for rock in China.

Christine L. Chung: I'm going to ask Chris to maybe comment on the reaction in China, and I will try to complement his comments.

Yeah.

I'm going to ask Chris to maybe comment on.

The reaction in China on I would try to complement of Chris's comments.

Absolutely.

Christine L. Chung: Absolutely. China has a slightly different patient population than what was covered in the global trials. And based on our historical phase three experience, as well as real world evidence based on

China has a slightly different patient population and what we discovered in the global trials and based on our historical phase III of experience as well as a way of world evidence based on 2 and a half years, Jeff on market used in China.

Christine L. Chung: on 2.5 years of OnMarket used in China.

Christine L. Chung: opinion leaders are seeing slightly different event rates. At this point in time, we're not seeing any over concern by our key investigators and key opinion leaders and HCPs about the U.S. Regulatory Guidance based on the ADCOM. As you know, every single health authority makes its own sovereign decision. FibroGen China sought approval.

Chinese key opinion leaders are seeing slightly different is that right.

At this point in time, we're not seeing any older concern by our key investigators and key opinion leaders from Hcp's about the U S.

Regulatory.

Guidance based on the AD Com as you know every single Health authority makes its own sovereign decision.

Hydrogen China sought approval of China based on a domestic class 1 when pathway, which meant that the data with only based on China data and to date. We will evidence is consistent with that experience. So at this point in time, we're not expecting any.

Christine L. Chung: [inaudible] on prescription levels and continued widespread adoption of Roxaducet in China based on the ADCOM outcome.

Enrique A. Conterno: I think it's fair to say that, as part of the outcome, we shared some data on... (inaudible)

Impact or any significant impact.

Operator: Okay, thank you for that. And then my other question is related to the delays in some of the trials, more specifically, the MDS trial, as well as, sorry, let me explain. Yeah, it's the MDS trial, as well as the DMD trial. And so could you give us a little bit more color on what's causing this? Is it slow enrollment, or is it something else?

On prescription levels and continued widespread adoption of rough to do just that in China of based on the AD com outcome.

Okay. Thanks.

I think it's fair to say, we as part of the outcome, we shared some data on.

Real world data on.

When it comes to pharmacovigilance in China.

We saw some of the reported rates in the real world when it comes to thrombosis for example.

Enrique A. Conterno: Yeah, we will provide a little bit of comment. It is really related to enrollment, and of course, enrollment is also impacted by current conditions, and we are seeing right now, um, DMD and IPF. And the current timeline that we provided assumes that these current conditions basically continue on. Mark, would you like to share more color? Sure, Enrique.

We're very very low.

Okay. Thank you.

For that and then my other question is related to the pit.

Some of the cloud more specifically.

At the Mds trial as well.

I'm sorry.

Yeah, if the MD as true.

As well as the theater.

Wow.

And so could you give us the little bit more color of whats cotton debt.

Is it a slowing of enrollment or is there something else.

Mark Eisner: And I agree with the comments about COVID. I mean, for MDS, you know, as you know, it's a rare disease. It's a 52-week placebo-controlled period.

Yes, we will provide a little bit of.

Comment it is really related to enrollment.

And of course enrollment is also.

Impacted by current conditions, and we are seeing right now.

Mark Eisner: You know, so it's challenging to find patients to enroll. We have opened up more than 40 additional sites around the world, and we are seeing increases in enrollment at those sites. So we're making every effort to enroll the MDS trials. And the way I would characterize it is that there's a lot of uncertainty around the enrollment rates month to month, and we are pushing very hard, though, and working very collaboratively with our investigators to enroll those trials. I mean, DMD is, you know, similarly, a very rare disease.

Conditions.

That are more challenging due to COVID-19. So some of the COVID-19 concerns.

And clearly that that creates a.

A bit of a disproportionate impact on when you look when we look at our trials.

In 3 patient populations.

Mds.

D M D.

IPF and the current diamond that we provided assume the current conditions basically continue on Mark would you like to share more color sure I agree with the comments about Covid I mean for Mds as you know, it's a rare disease.

The 52 week placebo controlled period.

So it's challenging to find the patients to enroll we have opened up more than 40 additional sites around the world and we are seeing increases in enrollment in the site. So we're making every effort to enroll the the Mds trials and the way I would characterize it is it's just there's a lot of uncertainty around the enrollment rates month to <unk>.

Mark Eisner: You know, these are young kids, in many cases, and the COVID situation looms large for the parents of those children and those kids. So, again, we're trying very hard to make those trials as user-friendly as possible and doing everything we can to enroll these kids. On the positive side, I mean, the PAM-Revlimab LAPC trials are actually enrolling very, very well, which I think speaks to the high medical need for that condition and the excitement around PAM for those conditions.

And we are pushing very hard, though and working very collaboratively with our investigators to enroll those trials.

M D similar.

Similarly, the very rare disease.

These are young kids in many cases.

On the Covid situation looms large for the parents of those children in those children. So again, we're trying very hard to make those Charles as user friendly as possible.

And doing everything we can to enroll those on the positive side I mean, the Pam rolling out of <unk> trials are actually enrolling very very well, which I think speaks to the high unmet medical need in that condition on the excitement around Pam for those conditions. So that's that's very favorable in the first 1.

Mark Eisner: So that's very favorable. And, you know, the Zephyrus 1 IPF timelines, we've announced for the first time publicly because we are making very good headway with enrollment there despite COVID, adding additional sites, working closely with the sites to enroll those patients. And also, you know, with the discontinuation of the Galapagos-Gilead trial, to try to capture the patients who would otherwise have gone into those trials into our trial, so that's looking pretty good.

Timelines you know we've announced for the first time publicly because we are making very good headway with enrollment there despite COVID-19.

Adding additional sites working closely with the sites.

On to enroll those patients and also with the Galapagos Gilead. The discontinuation you know we've been working to try to capture of the patients who otherwise would have been candidates for those trials into our trial.

On that that's looking pretty good right now.

Operator: Your next question comes from the line of Paul Choi with Goldman Sachs. Your line is now closed.

Your next question comes from the line of Paul Choi with Goldman Sachs. Your line's now on.

Operator: Hi, everyone. Thank you for taking our questions. This is Charlie. I'm on behalf of Paul.

Hi, everyone. Thank you for taking our questions business of Charlie on for Paul I, just had a quick 1 regarding the upcoming European decision and subsequent events.

Operator: I just had a quick one regarding the upcoming European decision and subsequent events. How are the conversations going with partner Astellas in the region? Are they talking about their commercialization strategies pending approval with the EMA? Are they going to be focusing on certain countries at this point? And are they incorporating any sort of kind of virtual or remote marketing efforts considering the potential threat for further COVID lockdowns later this year? Thank you very much.

What are how are conversations going with partner Astellas for the region are they talking about there.

Actually the Asian strategies pending the approval with the EMA are they going to be focusing on certain countries at this point.

The incorporating any sort of kind of virtual the remote marketing efforts considering the.

Potential pressure further COVID-19 Lockdowns later this year. Thank you very much.

Thane Wettig: Very good. I'm going to ask our Chief Commercial Officer, Thane Wettig, to provide some comments on the commercialization strategies in Europe, whatever we can share. Thane.

Very good I'm going to ask our Chief Commercial Officer, Spain, where inc to provide some comments on.

The commercialization strategies.

Thane Wettig: Yeah, thanks, Enrique, and thanks, Charlie, for your messages. Unfortunately, we're not going to be able to comment very much on Astellas, as you can imagine, in a highly competitive situation. There are certain things that they're not going to disclose, and we can't disclose on their behalf.

Europe, whatever you can share. Thanks, yeah, Thanks, Enrique and thanks, Charlie for your message. Unfortunately, we're not going to be able to comment very much with astellas as you can imagine.

In the highly competitive situation are there certain things that they're not going to disclose when we we can't disclose on their behalf I think what you could assume is that relative to a European launch it's going to take the form of other products that would be launching in Europe. So the the traditional markets that are first the launch will be the first.

Thane Wettig: I think what you could assume is that, relative to a European launch, it's going to take the form of other products that would be launching in Europe. So the traditional markets that are first to launch will be the traditional markets that will be the first to launch Roxadustat in Europe, as they then work through the other markets from a pricing and reimbursement perspective. Needless to say, there's a lot of excitement because we do have a really nice competitive advantage in the EU from a timing perspective, and I think you can rest assured that Astellas is going to take full advantage of that.

Traditional markets that will be first launch for rocks reduce debt in Europe as they then work through the other markets from a pricing and reimbursement perspective, needless to say theres a lot of excitement because we do have a really nice competitive advantage.

In the EU from a timing perspective, and I think you can rest assured that the installs was going to take full advantage of that.

Thane Wettig: One, just to remind everyone that Astellas has guided to revenue of $80 million for fiscal year 2021. That's $80 million. It was converted at the exchange rates at the time from yen. About half of that was for Japan, if I recall correctly, and about half of that was for Astellas, which was basically Europe and Japan. And Astellas also provided, as part of their strategic review, an overall peak sales expected for the product, which, once again, I'm translating from exchange rates at that time, but they were somewhere between half a billion U.S. dollars to a billion U.S. dollars in peak revenue when we look at Astellas' territory.

1 just to remind everyone that astellas has guided.

2.

Revenue of $80 million for fiscal year 2021.

That's $80 million it's.

It was converted that the exchange rates at the time from yen about half of that was Japan, if I recall correctly on about half of that was for our sellers was basically Europe outside of Japan.

So that's on the.

I'd say, that's also provided as part of the strategic review on overall.

Our peak overall peak sales of expected for the product, which once again I'm I'm I'm translating from exchange rates at the time, but there were somewhere between half a billion U S dollars to $1 billion, Inc. Big revenue when we look at the Astellas territories.

Operator: for the next question. Apologies. Your next question comes from the line of Jason Gerberry with Bank of America. Your line stands open.

Great next question.

My apologies. Your next question comes from line, Jason The Perry with Bank of America. Your line of stand alone.

Operator: Hi, this is Perry on the line for Jason. Thanks for taking our question. I have another regarding the CHMP opinion. Is there any risk that it doesn't stick? And additionally, what are the next steps from a regulatory standpoint, and when can we expect to get a label?

Hi, This is carey on the line for Jason Thanks for taking the question.

Regarding the <unk> opinion.

Is there any risk that it doesn't stick and additionally.

1 what are the next steps from a regulatory standpoint, and when can we expect to get a label in Europe. Thanks.

Operator: I expect to get a label in Europe. Thanks.

Yes, as I mentioned, we're expecting a decision on this.

Enrique A. Conterno: As I mentioned, we're expecting a decision this month. We are expecting a European Commission decision. Clearly, the scientific body assessed Roxodusta as having a clear benefit-risk profile. Keep in mind that many of the items that were discussed here were discussed as part of the review in Europe. And I'm going to ask Mark to maybe make a few other...

This month.

We.

Are expecting a European Commission.

The decision clearly.

The scientific body of assess.

Looks of do status of having a clear.

The breast <unk>.

Keep in mind that many of the items of the wear discuss here were discussed as part of the review in Europe.

And I'm going to ask maybe mark to maybe make a few of additional comments I think the point you made is the key 1 which is the <unk> has already reviewed all of the.

Mark Eisner: I think the point Enrique made is a key one, which is that the CHMP has already reviewed all of the efficacy and safety issues that have been up for discussion in the U.S. and issued a positive opinion. We think the European Commission decision will be positive, too. We don't expect the influence of the U.S. FDA's ADCOM on that decision. In terms of next steps for regulatory affairs in Europe, I believe it's just waiting for that EC decision.

Efficacy and safety issues that have been up for discussion in the U S and issue the positive opinion, we think the European Commission.

The decision will be will be positive we don't expect the influence of the U S. Fda's outcome on that decision.

In terms of the next steps for regulatory in Europe, I believe it's just waiting for that you see.

<unk>.

The decision and then that's the point in time, where the.

Operator: We have no further questions at this time. I will now turn the call back to our presenters for closing remarks.

The product and sort of the S. N P C in Europe will be come available.

So that's basically the regulatory situation in Europe.

Thank you.

We have no further question at this time I will now turn the call back to our presenters for closing remarks.

Enrique A. Conterno: Very well. I just want to once again thank everyone for participating. We very much appreciate your participation today on the investor call and your interest in FibroGen. Please enjoy the rest of your day. Thank you very much.

Yeah.

Very good I just want to.

Once again, just thank everyone for participating we very much appreciate your participation today.

On the.

The investor call on your interest in 5 or Gen <unk>.

Please enjoy the rest of the day, thank you very much.

Operator: Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.

Ladies and gentlemen, this concludes today's conference call. Thank you for participating you may now disconnect.