Q1 2020 Earnings Call

Control that may cause differences between current expectations in actual results, we were free to our annual report on a form 10 k. for the fiscal year ended December 31st 2019 into a quarterly report on form 10 Q. for the quarter ended March 31st Twentytwenty, followed with these securities and Exchange Commission.

Copies of these filings can be found in the investors section of our website.

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

The format for today's call includes prepared remarks from <unk> management team and then we'll open the lines to take your questions. The press release reporting our financial results in business update in a web cast of today's conference call. It can be found on the investors section of five virgins website at W.W.W. Fibrogen Dot com and.

Now I would like to turn the call over two Enrique Conterno Arsenio.

<unk>.

Thank you my good afternoon, everyone.

<unk>.

<unk>.

Given that salad.

Presented by that called 19, but dammit.

I would like to take a moment on behalf of fiber again.

Yeah sure patients.

Health care providers.

Investigators.

They called years of our continued commitment to bring the patients are potential.

<unk> for the Friedman crony.

Life threatening conditions.

Governments business sense on society in general.

Taking unprecedented measures to meet you gave to spread.

Coffee 19 outbreak.

Like many businesses Fibrogen has taken a number of.

<unk>.

Both our workforce I'm communities. These challenge in time.

The U.S.

Our employees are working remotely when possible.

While in China.

<unk> <unk> <unk> manufacturing plant.

The fields.

We implemented protocols globally.

Minimize the risk of illness for our employees will need to work on site any of our facilities.

Despite the difficult circumstances, we remain committed.

To ensuring that regulatory on commercial success of <unk>, this stuff potentially transformation or a medicine.

Therapy.

Yeah.

Demonstrated in patients with <unk>.

Operator: May cause differences between current expectations and actual results. We refer you to our annual report on Form 10-K for the fiscal year ended December 31st, 2019 and to our quarterly report on Form 10-Q for the quarter ended March 31st, 2020, followed by the Securities and Exchange Commission. Copies of these filings can be found in the investors section of our website. However, we undertake no obligation to update any forward-looking statement, whether as a result of new information, future developments, or otherwise. The format for today's call includes prepared remarks from FibroGen's management team, and then we'll open the lines to take your questions. The press release reporting our financial results and business update and a webcast of today's conference call can be found on the Investors section of FibroGen's website at www.fibrogen.com. And now, I would like to turn the call over to Enrique Conterno, our CEO. Okay, Enrique?

We <unk>, we are implemented in a comprehensive plan.

Enrique A. Conterno: Thank you, Mike. Good afternoon, everyone, and welcome to our first quarter 2020 earnings call. Given the challenges...

Bookseller rate developing across the three indication of your plastic with minorities type Rossi alright, yeah.

Locally.

Enrique A. Conterno: Presented by the COVID-19 pandemic, I would like to take a moment on behalf of FibroGen to reassure patients, healthcare providers, investigators, and stakeholders of our continued commitment to bring to patients our potential first-in-class medicine for the treatment of chronic and Life-Threatening Conditions. Governments, businesses, and society, in general have taken unprecedented measures to mitigate the spread of the COVID-19 outbreak. Like many businesses, FibroGen has taken a number of actions to support both our workforce and communities in these challenging times. The U.S. Our employees are working remotely when possible.

I'm respectable pancreatic cancer or L.A.P.C.

And you've seen muscular dystrophy or the M.D.

What the situation with coffee 19 improves.

Finally, we continue to the vines innovation, Oh far hypoxia <unk> or if.

And for next C.D. shoe growth Fox or or C.T.G.I. platforms.

Our business continuity plans already in effect.

We were seeing an impact or operations, resulting from calling 19, we remain calm for you then that's five region huh.

Enrique A. Conterno: While in China, they are now back working in our offices, manufacturing plant, and the field. We have implemented protocols globally to minimize the risk of illness for our employees who need to work on-site at any of our facilities. Despite the difficult circumstances, we remain committed to ensuring the regulatory and commercial success of Roxodusta, a potentially transformational or medical treatment, and AnemiaTherapy, demonstrated in patients with chronic kidney disease. With Pambrello Maps, we are implementing a comprehensive plan to accelerate development across the three indications of idiopathic pulmonary fibrosis, or IPF, locally advanced undetectable pancreatic cancer, or LAPC Why has the situation with COVID-19 improved? Finally, we continue to advance the innovation of our hypoxia-inducible factor, or HIF, and Connective Tissue Growth Factor, or CTGF, platform.

Resources capabilities to navigate through decent certain time.

Achieve our stated goals.

A sign that comes back on line.

We are continuing our manufacturing operations at lunch efforts there.

We have ample rocks supply.

Support both the <unk> launches and clinical trials in addition to education as well as stuff on <unk> clinical trials.

We will continue to monitor to see placement closely.

So our employees on patients.

<unk>.

Regulators and countless others, who interact with Fibrogen.

Please know our thoughts.

<unk> you.

And your family.

Now, let me begin with drugs to do stuff.

During the first quarter I Roxadustat N.B.A. submission west accepted by D.F.D.A.

Interaction with D.F.D.A. or the <unk>.

We expect action by <unk> date of December 20, 2020.

Europe.

The marketing author.

Station application fine for <unk> for the treatment off anemia in boats dialysis.

On non drowsy depend in patients with C.K.D.

You said expected in the second quarter of 2020.

We.

Enrique A. Conterno: Our business continuity plans are in effect, and while we're seeing an impact on our operations resulting from COVID-19, we remain confident that FibroGen has the resources and capabilities to navigate through these uncertain times and achieve our stated goals. As China comes back online, we are continuing our manufacturing operations and launch efforts there. We have ample drug supply to support both the ROCKSTAR-ZEUSTAD launches and clinical trials in additional indications as well as the PAMBRELU-MAP clinical trials. We will continue to monitor the situation closely, communicate with our employees and patients, and to the floor leaders, clinicians, regulators, and countless others who interact with FibroGen. Please know our thoughts are with you and your family. Now, let me begin with Rock the Deuce.

And our partners working diligently <unk>.

You're going to make these novel.

Personalized medicine available to us many patients worldwide as quickly as possible.

So I need to China.

As you know Brooklyn's, who said what's first approved in China.

And what's included in the National dropped reimbursement least or an R.D.L., which went into effect at the beginning of the year.

If you focus has been.

And continues to be.

Expanding hospital at least thing so that <unk> M.B. widely prescribe.

We saw a positive momentum in hospital resistance in January.

It's part of the coffee 19 restrictions.

Which costs I slowed down your newly seems from late January too late March.

I was we stand here today.

We have seen a theater return to a new normally sign.

We continued to be encouraged.

By the Roxadustat opportunity there.

Enrique A. Conterno: During the first quarter, a Roxedusta NDA submission was accepted by the FDA, and interaction with the FDA on the file continues. We expect action by the PDUFA date of December 20, 2020, in Europe. The Marketing Authorization Application filing for RoxaZusta for the treatment of anemia in both dialysis and diabetes and non-dialysis-dependent patients with CKD is expected in the second quarter of 2020, and our partners are working diligently in preparation to make this novel first-in-class medicine available to as many patients worldwide as quickly as possible. Now, turning to China.

The coffee 19, pandemic, however, still costing disruption in clinical trials across the globe.

I'd be F.D.A., you may all the regulatory agencies have each should guide.

For the conduct of clinical trials during the up on them.

We are incorporating.

Regular third recommendations appropriate applause or clinical trial.

Our first priority at Fibrogen.

He's insuring the safety and wellbeing of the <unk>.

<unk>.

Well, we do not intend to provide.

<unk> details <unk> on the on the impact of coffee 19 for each one of our trials.

We can say that we have seen any impact across all of our trials varying degrees.

Are most affected trial <unk>.

Enrique A. Conterno: As you know, Roxodusta was first approved in China and was included in the National Drug Reimbursement List, or NRDL, which went into effect at the beginning of the year. A key focus has been, and continues to be, expanding hospital listings so that ROC seducers can be widely prescribed. We saw positive momentum in hospital listings in January, before the start of the COVID-19 restriction, which caused a slowdown in new listings from late January to late February. As we stand here today... We have seen a steady return to a new normal in China.

<unk> I.P.S. trial.

Well, we decided to boss near term and Goldman for the face to face.

And are currently focused on providing continue to care for the patients who had already been involved.

The rest of on trials continue involvement.

I'll be at this lower rates.

In 2020, we are committed to accelerating and expanding the develop enough on <unk>.

So that and we have developed a comprehensive plan.

Which includes clinical side activation.

Graphic expansion protocol a madman.

Enrique A. Conterno: We continue to be encouraged by the Roxa two-step opportunity there. The COVID-19 pandemic, however, is still causing disruptions and clinical trials across the globe. The FDA, EMA, and other regulatory agencies have issued guidance for the context of clinical trials during the pandemic. We are incorporating.

That's one thing returns on your normal we come being the best position to upset or rates and well.

Are locally advice.

<unk> pancreatic cancer study continuous starring role.

We continue preparations for suffers too.

Or second I.P.S. height pays three study and our fate three programming you seen muscular dystrophy late at the beginning in the second half of the year.

In summary.

Enrique A. Conterno: These regulatory recommendations, as appropriate, are closed for clinical trial. Our first priority at FibroGen is ensuring the safety and well-being of the patients participating in our study. What we do not intend to provide are specific details on COVID-19 and the impact of COVID-19 on each one of our trials. However, we can say that we have seen an impact across all of our trials to varying degrees. Our most effective trial is pangreblumab Zephyrus, IPF, where we decided to pause near-term enrollment for the safety of patients and are currently focused on providing continuity of care for the patients who have already been enrolled. The rest of our trials continue enrollment, albeit at a slower pace. In 2020, we are committed to accelerating and expanding the development of PAMBREVO.

Spied coffee 19.

Continued to be focused on getting ready to do set approved in the U.S.

Advancing on bread with my development.

And finally, leveraging our expertise in both type books inducible factor unconnected faster growth factor biology.

<unk>.

Now I will turn it over to Pee on.

Provide you with a more in depth discussion of rocks at this stuff.

Thank you and we cake in the afternoon actually one.

2020 start has been busy.

And today I would like to leave use some of the Roxadustat highlight that's five this year.

Nikkei mentioned earlier, we continue to expect them to N.F.D.A. decision on our Roxadustat N.D.A. tie that deals with date of December 20 2020.

We have no indication D.F.D.A. will hold an advisory committee meeting, but we continue to prepare so much on late in case, one is catch up.

Enrique A. Conterno: To that end, we have developed a comprehensive plan, which includes clinical side activation, Geographic Expansion, and Protocol Amendments, such that once things return to a new normal, we can be in the best position to accelerate enrollment. Our locally advanced and respectable pancreatic cancer study continues to enroll patients. We continue preparations for SEVERUS-2, our second IPF phase three study, and our phase three program inducing muscular dystrophy is slated to begin in the second half of the year. In summary, despite COVID-19, we continue to be focused on getting Roxas Dustat approved in the U.S., advancing VampiroMap development, and finally, leveraging our expertise in both hypoxia-inducible factor and connected tissue growth factor biology to expand our pipeline of novel drugs. Now, I will turn it over to Peony, who will provide you with a more in-depth discussion of Roxas' steps.

Two ensures that that's in the U.S.B.N. upon or Astros any kind of continue commercialization preparations.

We planned to some that are faced three individuals study and poor efficacy and safety manuscript publication over the coming months.

In Europe, the marketing authorization applications filing for rocks at these that for treatment Nothing me a in both hi, Alice says a non dialysis dependency K.D. patients is expected in the second quarter of 2020.

In Japan, I pod R.S.L.S. continues the commercial launch off every man. So that's Japan's brand names for Roxadustat for treatment nothing neemia in by Alice says depend on patients.

<unk> supplemental M.B.A. <unk>, Hi, Alice says patients. It's currently under reveal five P.M.D.A.

We recently presented new analyses from my face to me rock cities that trials after <unk> annual National Kidneys Foundation.

Peony: Thank you, Enrique, and good afternoon, everyone. Our 2020 start has been busy, and today I would like to review some of the Rocks to Do set highlights thus far this year.

Spring clinical meeting.

And the conclusions can be summarized as following.

You know non dialysis patients.

Peony: As Enrique mentioned earlier, we continue to expect an FDA decision on our Roxas-DUCEP NDA by the PDUFA date of December 20, 2020. We have no indication the FDA will hold an advisory committee meeting, but we continue to prepare diligently in case one is scheduled. To ensure success in the US, we and our partner AstraZeneca continue commercialization preparation.

<unk> achieve comparable hemoglobin corrections.

<unk>.

Similar to those says regardless of Iran status at baseline.

Rocks to use that cheating at least so that you may statistically significant reduction in breathless, So transfusion list of 74%.

40% off the patient.

Non by Alice as patient pool, what not hiring replete.

Or did not have sufficient islands stores to even qualify for like you said treatment.

Peony: We plan to submit our Phase 3 individual study and pool efficacy and safety manuscripts for publication over the coming months. In Europe, a marketing authorization application filing for Roxifusab for treatment of anemia in both dialysis and non-dialysis dependent CKD patients is expected in the second quarter of 2020. In Japan, our partner, Astellas, continues the commercial launch of Evarenzo, the Japanese brand name for Roxas Ducet for the treatment of anemia in dialysis-dependent patients.

Furthermore.

Roxadustat reduce the risk of Red blood cell transfusions, and I.V., Iran rescue compared to placebo your non by Alice says he K.D. patient regardless of.

I run status that baseline.

Finally, roxadustat significantly reduce the risk of that's let's sell transfusion in by Alice says patients.

<unk>.

Let me point out the Bronx abuse that but that's enough transfusion with goes hand in hand, with the superior hemoglobin advocacy achieve in art primary employment analysis compared to eat fault.

Peony: Stella's Supplemental MDA for Anemia in Non-Biolysis Patients is currently under review by PMDA. We recently presented new analyses from our Phase 3 Roxa-DUCEP trials at the annual National Kidney Foundation Spring Clinical Meeting, and the conclusions can be summarized as following.

Roxadustat superior hemoglobin change and transfusion with action.

Accompanied by favorite both cardiovascular safety without.

Let's take a law.

In that 1500, and 30 patients insert them dialysis pool.

Peony: In our non-biolysis patients, Roxibustat achieved comparable hemoglobin corrections, with similar doses regardless of iron status at baseline. RUX diffuse step treatment resulted in a statistically significant reduction in regular cell transfusion risk of 74%. Forty percent of the patients in this non-biolysis patient pool were not iron-replete or did not have sufficient iron stores to even qualify for ESA treatment.

Bucks it used to how to 30% lower risk off mace and 34%.

Lower risk of Mace, plus then you pull it <unk> alpha.

This is highly relevant as 86% of U.S. dialysis patients have not receive you set their p. in the 12 months prior to the initiation enough dialysis.

Collectively these results give us confidence that Roxadustat may have to differentiate that part of poll file for by Alice says depends on patients.

Beyond C.K.D.

Peony: Furthermore... Roxifustat reduced the risk of red blood cell transfusion and IV iron rescue compared to placebo in non-biolysis CKD patients regardless of Iron Status at Baseline. Finally, Roxafufat significantly reduced the risk of red blood cell transfusion in biolysis patients compared to Hippolytin Alpha. Let me point out that Roxibustat's reduction of transfusion risk goes hand-in-hand with the superior hemoglobin eff Roxette Dusset's Superior Hemoglobin Change and Transfusion Reduction are accompanied by favorable cardiovascular safety results, particularly. In the 1530 patient incident dialysis pool, Roxas Dufat had a 30% lower risk of MACE and 34% lower risk of MACE plus than Important Alpha. This is highly relevant as 86% of U.S. dialysis patients have not received ISSA therapy in the 12 months prior to the initiation of dialysis.

Vision, it's four roxadustat could become the standard of care for I mean, yeah Broccoli, we continued developmental rocks at these that for the treatment enough anemia associated with Milo This plastic syndrome, or M.D.S.N. chemotherapy induce amelia or C.I.A.

We also continue to you about all the way roxadustat for the treatment of anemia associated with ambition no diseases.

Starting with our face to me global study evaluate them roster does that for the treatment of anemia in M.B.S.. We presented positive result from open label Porsche enough. This study at American Society of Hematology plenty 19.

And I'm now conducting the randomize double blind placebo.

Placebo controlled portion of the study.

As a reminder, this second portion of the study will enroll approximately hundred and 60 transformation depend on M.D.S. patients in a three that few randomization and the primary advocacy measure is per cent of patients who achieved transfusion independence.

Staying in the hematology oncology space. We also have an ongoing face to open label study in C.I.A., which continues to be an unmet medical need.

We will continue to monitor assess and manage the impact of covert 19 with patient safety I saw a top priority.

Christine L. Chung: Collectively, these results give us confidence that Roxas-DUCEP may have a differentiated product profile for biolysis-dependent patients. Beyond CKD, our vision is for Roxibustep to become the standard of care for anemia broadly. We continue to develop Roxibustep for the treatment of anemia associated with myelodysplastic syndrome, or MDS, and chemotherapy-induced anemia, or CIH. We also continue to evaluate ROC's diffuse map for the treatment of anemia associated with additional diseases, starting with our phase three global study evaluating Rastadustat for the treatment of anemia in MDS. We presented positive results from the open-label portion of this study at the American Society of Hematology, 2019, and I'm now conducting the randomized double-blind placebo-controlled portion of the study. As a reminder, this second portion of the study will enroll approximately 160 transfusion-dependent MDS patients in a 3-to-2 randomization, and the primary efficacy measure is the percent of patients who achieve transfusion independence.

<unk>, thank all our investigators for their commitments and partnerships in developing new treatment options for patients.

Finally in collaboration with a partner Astra Zeneca.

Roxadustat marketing authorization applications for C.K.D. anemia has been submitted in a number of countries, including Canada, Australia, Mexico, Brazil, Taiwan, and South Korea.

I would now like to turn the call over to Chris tongue, who will discuss the recent developments, but roxadustat in China.

Thank you P. I mean.

I'm excited to share details of the positive progress made during the first quarter on the rocks to be set launch in China.

As many of you know Roxadustat, which included in the 2019 national reimbursement correctly last November.

Claim effective January 1st of this year.

<unk> roll out is completed on an accelerated pace.

Hospital, the things happen to keep focused about much effort on the top priority.

Dedicated roxadustat tail.

We are pleased with our progress to date.

Lots of these that's now listed at available many hospitals within our target universe.

Christine L. Chung: Staying in the hematology-oncology space, we also have an ongoing Phase II open-label study in CIA, which continues to be an unmet medical need. We will continue to monitor, assess, and manage the impact of COVID-19 with patient safety as our top priority. We thank all our investigators for their commitment and partnership in developing new treatment options for patients. Finally, in collaboration with our partner, AstraZeneca. Roxaducet marketing authorization applications for CKD anemia have been submitted in a number of countries, including Canada, Australia, Mexico, Brazil, Taiwan, and South Korea. I would now like to turn the call over to Chris Chung, who will discuss the recent developments for Roxas Ducet in China.

We have particularly clean with a penetration at top tier class three institutions, which are the marker account and also where key opinion leaders and early adopters crap.

We believe the hospitals, where we are listed to date represent greater than 30% of the potential C.K.D. a media market opportunity in China.

Luckily he said that sales for just under 5 million for the quarter.

Two one represents the first quarter after the inclusion of rocks to keep that in an R.T.L. and obviously sales were affected by the code at 19 from them.

<unk> January and February China was essentially locked down and sales listens where completely stopped.

During that time sufficient some hospitals are the largely focused on treating cobot 19 patients.

The number of non dialysis outpatient visit.

Christine L. Chung: Thank you, Peony. I'm excited to share details of the positive progress made during the first quarter on the Roxoducet launch in China. As many of you know, Roxaduce was included in the 2019 National Reimbursement Drug List last November. It became effective on January 1st of this year, and the government is ensuring that the rollout is completed on an accelerated basis. Hospital listings have been a key focus of our large efforts and the top priority of the AstraZeneca dedicated RoxyDucet sale. We are pleased with our progress to date. Roxaduce is now listed and available at many hospitals within our target universe. We are particularly pleased with the penetration at top tier Class 3A institutions, which are larger accounts and also where key opinion leaders and early adopters practice.

<unk> impossible.

This is for us affected but to a lesser degree.

Looking forward to Q2 weeks that the operations in China to return to a normal where social distancing rules will continue to apply.

Christine L. Chung: We believe the hospitals where we are listed to date represent greater than 30% of the potential CKD anemia market opportunity in China. Roxas, you said that sales were just under $5 million for the quarter. Kyuwon represents the first quarter after the inclusion of RoxabuseZ in NRDL, and obviously, sales were affected by the COVID-19 pandemic. From late January through the end of February, China was essentially locked down, and sales visits were completely stopped.

Sales representatives are now able to conduct sales visits and hospital lifting committee meetings are being scandals.

Many forms of scientific engagement have moved to digital.

Where disease education.

Discussion and Roxadustat experience of sharing and having conducted primarily online in the virtual manner.

We have seen <unk> utilization across different patient populations, including he moved dialysis.

Parakhin your dialysis and non dialysis.

And in both so naive to treat patients.

We continue to be encouraged by the human body proposition of recipes that from the treatment of an N.T.K.D. in particular within the treatments getting in China.

Given the weekends need for into dangerous I into cheap target hemoglobin levels, even the presence of inclination of relative or allowed took a little strange.

We look forward to keep you updated.

<unk> advance our work toward the long term goal of making love could use that the standard of care in treaties T.K.P.N. annotations in China.

I went outside the call overhead Elliott who.

Who will provide an update on the <unk>.

Christine L. Chung: During that time, physicians and hospitals were largely focused on treating COVID-19 patients. The number of non-dialysis outpatient visits was highly impacted, and dialysis visits were also affected, but to a lesser degree. Looking forward to Q2, we expect our operations in China to return to a new normal, where social distancing rules will continue to apply, sales representatives are now able to conduct sales visits, and hospital listing committee meetings are being scheduled. Many forms of scientific engagement have moved to digital, where disease education, case discussions, and Rocks at UCEDD the experience of sharing are now being conducted primarily online in a virtual manner.

Yeah.

Thank you, Chris and good afternoon.

Today, I would like to provide an update on our revenue my program.

Given the covert 19 development over the recent months.

As you all know we all <unk> in three separate orphan diseases.

At the time of our last Ernie Cold, we were enrolling zephyrus.

Demise double blind placebo controlled phase three studies.

Evaluating found <unk>.

And then also plans to initiate the second similar based three trials and I doubt name Zephyrus too.

Given the recent covert 19 pandemic.

In order to ensure patient safety in this world population was compromised lung function. We have decided at this time to temporarily pause enrollment of Zappers phase three clinical study.

Elias: We have seen roxoducet utilization across different patient populations, including hemodialysis, peritoneal dialysis, and non-dialysis, and in both ESA Naive and ESA-treated patients. We continue to be encouraged by the unique value proposition of roxodustat in the treatment of anemia and CKD, in particular within the treatment setting in China, given the reduced need for intravenous ion to achieve target hemoglobin levels, even in the presence of inflammation, as well as the oral route of administration. We look forward to keeping you updated as we advance our work toward the long-term goal of making RoxasVuSat the standard of care for treating CKD anemia patients in China. I will now turn the call over to Elias, who will provide an update on the Tumrevemet program. Fabio?

The safety of our patient is our <unk> top priority.

As we continue to assess this dynamic situation and we continue to work was investigators to provide care.

Clinical trial continue with you for patient who are already enrolled in this trial.

Prior to voicing enrollment we were focus on accelerating enrollment of our ingoing zephyrus.

Phase three study in preparing to initiate this efforts to trial.

Do they extent possible we continue with these preparations such as when we are able to restart their enrollment we will hit the ground running.

Moving onto all our locally advance and respectable pancreatic cancer or L.A.P.C. program.

Elias: Thank you, Chris, and good afternoon. Today, I would like to provide an update on our Pam Revlimab program given the COVID-19 development over the recent months. As you all know, we are developing paramevrimab in three separate orphan diseases. At the time of our last earnings call, we were enrolling Zephyr, a randomized, double-blind, placebo-controlled Phase III study. Evaluating Pamela Blumab in IPF, and NUS plans to initiate a second similar phase 3 trial in IPF named Zephyrus II, given the recent COVID-19 pandemic. In order to ensure patient safety in this vulnerable population with compromised lung function, we have decided at this time to temporarily pause enrollment in Zephyrus Phase III clinical studies. The safety of our patients is our top priority. As we continue to assess this dynamic situation, and we continue to work with investigators to provide care and clinical trial continuity for patients who were already enrolled in this trial. Prior to opening enrollment, we were focused on accelerating enrollment of our ongoing Zephyrus trial. phase 3 study in preparing to initiate the Zephyrus II trial. To the extent possible, we continue these preparations, such as when we are able to restart enrollment, we will hit the ground running.

<unk> <unk> ongoing randomized double blind placebo controlled phase three trials in patients with L.A.P.C.

As you know these patient how the grave.

No says.

We are working with our investigator and clinical trials side stuff to implement changes, which mitigate the risk to patient and comply with regular three in government guidance.

We continue to prepare to initiate a phase three trials lantos evaluating found revenue mob as if treatment for the shared muscular dystrophy or D.M.D. in the second half of 2020.

There is a significant interests for D.M.D. help from the D.M.D. health care provider inpatient communities.

This global trial will be randomized double blind placebo controlled phase three trials I'm revenue map in patients with non ambulatory D.M.D.

It will enroll approximately 90 patients randomized went to one two placebo.

Habit treatment period of 52 weeks.

No I was during the cold over to I.C.S., though buys cotroneo for the financial update but.

Thank you alias as announced today total revenue for the first quarter of 2020 was $24.4 million as compared to $23.9 million for the first quarter of 29 10.

The current quarter revenue consists of $19.4 million in development revenue plus net product revenues of $5 million for Roxadustat sales in China.

Pat Cotroneo: Moving on to our Locally Advanced and Respectable Pancreatic Cancer, or LAPC, program. LAPIS is our ongoing, randomized, double-blind, placebo-controlled, phase 3 trial in patients with LAPC. As you know, these patients have a grave prognosis, and we are working with our investigators and clinical trial site staff to implement changes which mitigate the risk to patients and comply with regulatory and government guidance. We continue to prepare to initiate a Phase 3 trial, Lelantos, evaluating pamrevlimab as a treatment for Duchenne muscular dystrophy, or DMD, in the second half of 2020. There is a significant interest from the DMD healthcare provider and patient community. This global trial will be a randomized, double-blind, placebo-controlled Phase III trial of famrevumab in patients with non-ambulatory DMD. It will enroll approximately 90 patients, randomized one-to-one to placebo, and have a treatment period of 52 weeks. Now, I will turn the call over to our CFO, Pat Cotroneo, for the financial update. Pat?

For the same period operating costs and expenses were $105.5 million.

Net loss for $78.3 million or 89 cents per basic in diluted share.

As compared to operating costs and expenses $72.7 million and the net loss of $45.4 million or 53 cents per basic and diluted share for the first quarter. This year.

Included an operating costs and expenses for the quarter ended March 31, 2020 wasn't an aggregate noncash portion totaling $22.1 million.

Which $16.9 million was a result, the stock based compensation expense as compared to an aggregate noncash portion of $20.4 million.

Which $16.4 million was the results of stock based compensation expense for the same period than the prior year.

And March 31, five Virgin had $598.4 million in cash cash equivalent restricted time deposits investments and receivables.

As previously stated in accordance with the U.S. gap, we recognized in our Q2 2019 financial results a total of $180 million of milestone payments when achievement became probable.

Pat Cotroneo: Thank you, Elias. As announced today, total revenue for the first quarter of 2020 was $24.4 million, as compared to $23.9 million for the first quarter of 2019. The current quarter's revenue consists of $19.4 million in development revenue, plus... net product revenues of $5 million for Roxadustat sales in China. For the same period, operating costs and expenses were $105.5 million, and the net loss was $78.3 million, or $0.89 per basic and diluted share, as compared to operating costs and expenses of $72.7 million and a net loss of $45.4 million, or $0.53 per basic and diluted share Included in operating costs and expenses for the quarter ended March 31, 2020, was an aggregate non-cash portion totaling $22.1 million, of which $16.9 million was a result of stock-based compensation expense. At March 31, FibroGen had $598.4 million in cash, cash equivalents, restricted time deposits, investments, and receivables.

The amount was comprised of $50 million frantic dissipated milestone from Astra zeneca related to the filing of the U.S.N.T.A.

Which was received on April 120 20.

And $130 million, an anticipated milestones from a stylus in connection with the U.M.A. filings, which we expect to occur in the second quarter. This year.

Based on these milestone payments and our latest forecasts data, we continue to estimate or 2020 and in cash balance of cash cash equivalents restrict the time deposits investments and receivables to be in the range of $720 million to $730 million assuming U.S.N.D.A.

Approval can queue for 2020.

Looking ahead, we have a total of $375 million in anticipated milestones expected over the next 15 months for the U.S. in Europe.

Which includes the aforementioned $130 million a milestones for M.A. submissions.

Plus $245 million of milestones on approvals and first commercial sale.

At this point in time, we have no changes and expectations in any of the anticipated milestones over the next 15 months.

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

Thank you Pat.

Pat Cotroneo: As previously stated, in accordance with U.S. GAAP, we recognized in our Q2 2019 financial results a total of $180 million of milestone payments when achievement became probable. The amount was comprised of $50 million for an anticipated milestone for AstraZeneca related to the filing of the USNDA, which is expected to be received on April 1, 2020, and $130 million in anticipated milestones from Astellas in connection with the EU M&A filings, which we expect to occur in the second quarter this year. Based on these milestone payments and our latest forecast data, we continue to estimate our 2020 ending cash balance of cash, cash equivalents, restricted time deposits, investments, and receivables to be in the range of $720 to $730 million, assuming U.S. NDA approval in Q4 2020.

In closing.

Fabric thing as well positioned to navigate decent certain time.

We and our partners are committed to making roxadustat available, but many patients across the globe as quickly as possible.

We have ample supply of up to do stuff bruck products to meet demand for the year and I'm full supply or reveille about for a plan cynical trials.

As well so just for sales ramp up.

Our financial position is strong.

With the <unk> 600 million cash at the end of the first quarter.

We have a total of 375 million MMCC paid milestones expected over the next 15 months in the U.S. and your.

Which includes 130 million of milestones for the M.M.A. fighting.

Hello.

245 million milestones when approvals and first commercial sales.

In addition, we receive food partner reimbursement for development I'm commercialization of rocks to do stuff all geographies, except China.

Pat Cotroneo: Looking ahead, we have a total of $375 million in anticipated milestones expected over the next 15 months for the U.S. and Europe, which includes the aforementioned $130 million of milestones for M.A.A. submissions, plus $245 million of milestones on approvals and first commercial sale. At this point in time, we have no changes in expectations for any of the anticipated milestones over the next 15 months. Thank you, and I would now like to turn the call back over to Enrique.

Where we shared his expenses 50, 50 with us or Seneca.

Based on our current forecast.

We are reiterating overestimated 2020 and be gosh, the being the range of $720 million to $730 million and continued to believe where we'll find.

For years to come.

Now.

Liked to turn to call back to the operator for questions.

Operator.

Thank you as a reminder to ask a question you will need to press the starts in the one key on your touch tone telephone.

Enrique A. Conterno: Thank you, Pat. In closing... FibroGen is well positioned to navigate this uncertain time. We and our partners are committed to making Roxatustat available to as many patients across the globe as quickly as possible. We have ample supply of Roxodusta drug products to meet demands for the year, and we have ample supply of pancrevumab for a planned clinical trial, as Roxas Dusta tells Rampart. Our financial position is strong, with approximately $600 million in cash at the end of the first quarter. We also have a total of $375 million in anticipated milestones. We expect it to be available over the next 15 months in the US and Europe, which includes $130 million of milestones for the MMA filing, plus $245 million of milestones on approvals and first commercial sales.

To withdraw your question press the pound key.

<unk> roster.

[noise] Oh first question.

Comes from Michael you, but Jeffrey's your line is open.

Enrique <unk> gosh, two questions for me thinking only okay.

There was that recently doesn't competitor of data that came out. This week, maybe you could just talk about how to put that into context importantly in the Dallas to segment. The only 10% of the population an incident, where you had I think approach a 40% you guys at the same hazard ratio is your 0.96, so maybe talk to.

Data set and what that would mean both incident diocesan stable analysis, when you're trying to compare that data.

Second question is on China <unk>. Good comments, there maybe talk about how you expect Q2, three four to ramp as people are modeling <unk>. Thank you.

Enrique A. Conterno: In addition, we receive full partner reimbursement for development and commercialization of rocks induced in all geographies except China, where we share these expenses 50-50 with AstraZeneca. Based on our current forecast... We are reiterating our estimated 2020 ending cash to be in the range of $720 to $730 million and continue to believe we are well financed for years to come. Now, I would like to turn the call back to the operator for questions.

Very good thank you very much Michael for for the question.

I'm going to turn over stuff question on the recent competitive data to be on it but let me just make a comment on that these communities data.

Because I think in in in a in an important away, but I'm excited for us to be able to also say or why are we so excited about rock to do stuff.

In terms of <unk>, Jason and we would then go to Chris for your question from China in terms of cells from from.

Operator: Operator. Thank you.

Operator: As a reminder, to ask a question, you will need to press the star and the 1 key on your touchtone telephone. To withdraw your question, press the pound. Please stand by while we compile the Q&A roster. Our first question comes from Michael Yee on Jefferies. Your line is open.

<unk>.

Thank you and we can thank you Mike for asking the question recent data we have firms the safety of to his class. That's not every case had in addition, we are sure that the Roxadustat <unk>. It's compelling this is a great opportunity to remind you.

Enrique A. Conterno: Hey Enrique, hey Peony, hey guys, two questions from me if you can hear me okay. There was some competitor data that came out this week. Maybe you could just talk about how to put that into context. Importantly, in the dialysis segment, they only had 10% of the population in incidents, where you had, I think, upwards of 40%, yet you guys had the same hazard ratio of 0.96. So maybe you could talk about that data set and what that would mean, both in incident dialysis and stable dialysis, when you try and compare that data. And then my second question is about China. Chris, I thought you had some good comments there. Maybe talk about how you expect Q2, Q3, and Q4 to ramp up.

That's about the differentiating aspect also roxadustat.

<unk> ethnic to see standpoint, Roxadustat is medically and statistically superior and hemoglobin advocacy endpoint.

Which Danny Interand translates into clinical benefit off reduction off transfusion in dialysis patients a primary advocacy and point of change from baseline two weeks 28 252.

West superior to.

Two and act as compared to her after we'd mats <unk> comparison, and the P. value is less than point O.O. one.

Enrique A. Conterno: Very good. Thank you very much, Michael, for the questions. I'm going to turn over the question on the recent competitive data to Peony, but let me just make a comment on that. Clearly, this data... I'm excited for us to also share why we are so excited about ROC-L2STAT in terms of differentiation.

Now what is very we also have statistically significant reduction in transfusion list.

<unk>, we have demonstrated cardiovascular safe p. in the overall by Alice says population and in a in <unk> nice and Furthermore, we demonstrate a reduction <unk>.

Peony: and we will then go to Chris for your questions on China in terms of sales ramp-up.

In our 1500 and 30, instead, then dialysis patient pool.

Peony: Thank you, Enrique, and thank you, Mike, for asking the question. Recent data reaffirms the safety of the HIF class, as Enrique said. In addition, we are reassured that the ROCKFOR-DUCEP product profile is compelling. This is a great opportunity to remind us about the differentiating aspects of ROCKFOR-DUCEP.

Where the comparison between Roxadustat with you pull it 10 Alpha star that within the first four months off dialysis initiation.

Roxadustat, how to 30% lower with stuff mace, and 34% lower risk off a mace plus then you'd pull a tent alpha with a trend points lower all costs mortality.

Peony: From an efficacy standpoint, Roxifusta is numerically and statistically superior in hemoglobin efficacy endpoints, which then in turn translates into clinical benefit of reduction of transfusions in dialysis patients. A primary efficacy endpoint of change from baseline to weeks 28 to 52 was superior to an active comparator after we met the non-inferiority comparison, and the p-value is less than 0.001.

Relative to <unk> Alpha.

Now this is a highly relevant population.

The difference between the incident dialysis and the staple dialysis is that incident dialysis is this <unk> the point of entry timing off the entry into this study.

Patients. This includes patients who has thought it by Alice says <unk> Fomon stuff study and Roman and continue receiving treatment well into stable period ask the average treatment Miss around two years.

And.

<unk> addressed that the question off.

Peony: Now, what is very important, we also have a statistically significant reduction in transfusions. Importantly, we have demonstrated cardiovascular safety in the overall dialysis population and in MACE, and furthermore, we demonstrated a reduction in MACE plus risk in our 1,530 incident biolysis patient pool, where the comparison between Roxitustat with Epoetum Alpha started within the first four months of dialysis initiation. Roxy Fusedat had a 30% lower risk of MACE and 34% lower risk of MACE plus than Ypolitan Alpha, with a trend towards lower all-cause mortality relative to Ypolitan Alpha. Thus, this is a highly relevant population.

That you have brought up about staple dialysis the other stuck with off the all dialysis patient I patients who entered a study.

At the time that they have been on dialysis for more than four months.

And continue treatment.

When we look at the convert it patients or the staple dialysis patients.

And evaluate and looking at a safety cardiovascular safety it does not change any of the conclusions.

That we have about roxadustat being safe and efficacious.

And so it's <unk>.

In conclusion.

<unk>.

Excellent cardiovascular safety profile.

With a statistically significant and clinically meaningful higher hemoglobin advocacy results.

And lower transfusion rate to relative to each <unk> alpha.

Peony: The difference between incident dialysis and stable dialysis is that incident dialysis describes the point of entry, the timing of the entry into the study. This includes patients who have started dialysis within four months of study enrollment and continue receiving treatment well into the stable period as the average treatment is around two years. And to address the question that you have brought up about stable dialysis, the other subgroup of the all-dialysis patients are patients who entered a study at the time that they have been on dialysis for more than four months and Continued Treatment. When we look at the converted patients, or the stable dialysis patients, and evaluate and look at cardiovascular safety, It does not change any of the conclusions about Roxa DuSTEP being safe and efficacious.

To gather makes roxadustat potentially a better treatment option for dialysis depend on patients.

We like the hand that we half and expect the <unk> to reflect the we south of clinical trials on our compounds.

Okay.

Now where are you going to for you a question because yeah because of the stable population and doing the math around that versus them show incident as important and I appreciate.

The the response and maybe Chris I'm trying to.

<unk> <unk>.

<unk>.

Yes, Hi, Mike.

So we continue to be optimistic about second third and fourth quarter. The way to look at the numbers might be you saw the two for numbers and you saw that C. one numbers. So what does the two one numbers tell you.

So there is seasonality in terms of when the things typically come in in China.

So I you know without missing you can't to prescribe. So the things are key but also there's tremendous momentum coming out of an R.D.L. to that because it makes the drop affordable I didn't mix hospitals wants to it.

So we are very happy with the two when numbers it reflects momentum coming out of N.R.D.L.

Peony: And so, in conclusion... rocks a few steps excellent cardiovascular safety profile coupled with the statistically significant and clinically meaningful higher hemoglobin efficacy results and lower transfusion rates relative to epotent alpha together make Roxifusat potentially a better treatment option for dialysis-dependent patients. We like the hand that we have and expect the product label to reflect the results of clinical trials on our compound.

It reflects a bit of a slow down because of <unk>.

We now coming out of code it into new normal.

It's a little bit touch and go it's it's hard to predict based on it but we continue to be very optimistic about the rest of the year looks like.

Hmm. Thank you guys appreciate it.

Thank you and our next question comes from Jeffrey porches with S.V. be Leery. Your line is open.

Oh and N.D.D. bus is D.D. I'm curious Chris Festival in China, What's your assessment of how this will play out over the long time.

Pathetically do you think that they're roughly equal or do you think that was going to ultimately be significantly larger than the other and then we could I know you're responsible for commercialization, but I'd love to hear your color on what you think the situation will be in the U.S. again do you think of the opportunity will be larger dialysis given you.

Peony: Okay. You can appreciate the question because of the stable population and doing the math around that versus them. So, this incident is important, and I appreciate it, the response, and maybe Chris on China. Yes, hi, Mike.

Christine L. Chung: So we continue to be optimistic about the second, third, and fourth quarter. The way to look at the numbers might be you saw the Q4 numbers, and you saw the Q1 numbers. So what do the Q1 numbers tell you? So there is seasonality in terms of when things typically come in in China. So, as you know, without listings, you can't prescribe.

The data or do you think.

Maturity will be getting the non though.

So who <unk> <unk>, let me try to address both of your question.

Looking at the the a relative size bubbles dialysis <unk> clearly.

Christine L. Chung: So listings are key, but also, there's tremendous momentum coming out of NRDL to list because it makes the drug affordable, and it makes hospitals want to list. So we are very happy with the Q1 numbers. It reflects momentum coming out of NRDL, but it also reflects a bit of a slowdown because of COVID. We're now coming out of COVID into a new normal. It's a little bit touch and go, so it's hard to predict based on it, but we continue to be very optimistic about what the rest of the year looks like. Thank you guys, I appreciate it. Thank you. And our next question comes from Jeffrey Porges with SVB Leary. Your line is open versus Didi. I'm curious, Chris. First of all, in China, what's your assessment? Hypothetically, do you think that they're roughly equal, or do you think that one is going to ultimately be significantly larger? And then, Enrique, I know you're not responsible for commercialization, but I'd love to hear your thoughts on what Project in Dialysis would be, given your incident dialysis data.

A number of patients.

<unk>.

That are on <unk>, <unk>, but the opportunity to help patients and non depending <unk> is of course much much larger.

I you both opportunity important opportunities, but over time I view the opportunity <unk> depends on patients to be much larger does opportunities in the.

Oh of course.

We we <unk>, we would need to do our our job during the pizza.

Axis and <unk> for now.

They do.

When he comes to the U.S. I I know you you been in any way, but I I you engage when <unk> <unk> insuring that we can have a successful commercialization.

Or <unk> and I had the opportunity to.

Do engage of course with <unk> the <unk> the sea fishing there follows I think the similar comments I can sign being the indeed, the opportunity overtime has the potential to be significantly larger as we develop that market and we should have the patience our our.

Created keep in mind that when we look at.

Enrique A. Conterno: Very good, Jeff. Let me try to address both of your questions. Looking at the relative size of both dialysis and non-dependent dialysis, clearly, the number of patients that have anemia that are on dialysis is significant, but the opportunity to help patients on non-dependent dialysis is, of course, much, much larger. I view both opportunities as important opportunities, but over time, I view the opportunity for non-dialysis-dependent patients to be much larger than the opportunity for dialysis patients. We will need to do our job to ensure that patients are accessing treatment for anemia patients that have CKD. When it comes to the U.S., I know you didn't mean it this way, but I am completely engaged when it comes to ensuring that we can have a successful commercialization of Rocadouza.

Patients coming in.

Dolphins today are we look at the prior 12 month.

Only about.

40% of them are treated for I mean, yeah, those prior 12 months.

So a great opportunity or thing to ensured that many many patients good appropriately treated clearly a huge opportunity for market expansion there.

Great. Thank you very much.

Our next question comes from Jason Gerberry with Bank of America. Your line is open.

Yeah. So this curious if you can comment on your 2020 rocks or publication strategy I imagine your competitor, we'll be looking to make a splash today and then later this year and so I know that there's some data points regarding the rocks program first.

That's the date or on the Mace sub components for the D.D. study I'm just curious if we could get any more incremental data published out of you guys. Later this year, making comments at all on the front.

Enrique A. Conterno: And I had the opportunity to engage, of course, with AstraZeneca. The situation there follows, I think, similar comments as in China, where the NDD opportunity over time has the potential to be significantly larger as we develop that market and we ensure that patients are treated. Keep in mind that when we look at patients coming in to the office today and we look at the prior 12 months, only about 14% of them are treated for anemia prior to asthma. So, great opportunity, I think, to ensure that many, many patients get appropriately treated and clearly a huge opportunity for market expansion there. Thank you very much.

And then maybe just follow up for Chris you know help us think about the 5 million dollar number for for China. This quarter is that a pure demands driven number I assume in inclusive of the the code. It had when you mentioned.

80% of hospitals have access to rocks, but I think Empire conversations you talked about the N.D.D. market requiring more market building. So if you we think about that access as being more around the D.D. opportunity or at least at the onset. Thank you.

Yep.

Thank you have you do some for the question I'm Gonna at you only need to come in.

On our publication strategy. We are excited about publications are we publication planning what we're trying to do this year and then I'm Gonna, Chris who either some more color in China Johnny.

Yes.

I am very excited about upcoming publication plan I, we could I dare say that we aren't data rich and we're working very closely with our two partners <unk> <unk> something we are committed to submit to our face to be.

Enrique A. Conterno: Thank you. Our next question comes from Jason Gerberry with Bank of America. Your line is open.

Operator: I was just curious if you could comment on your 2020 ROXA publication strategy. I imagine your competitor will be looking to make a splash at ASN later this year, and so I know that there are some data points regarding the ROXA program. For instance, the data on the MACE subcomponents for the DD study. I'm just curious if we could get any more incremental data published out of you guys later this year, if you can comment at all on that front. And then maybe just a follow-up for Chris.

Joel studies as well as pool ethic, 'cause T. and safety manuscripts fall publications over the coming months. We also plan to submit a number of abstract to E.S.N., which will be held in October up this year.

Say to stay tuned.

Thank you got to hear it.

Operator: Help us think about the $5 million number for China this quarter. Is that a pure demand-driven number, I assume, inclusive of the COVID headwinds? And you mentioned 30% of hospitals have access to ROXA, but I think in prior conversations you talked about the NDD market requiring more market building. So should we think about that access as being more around the DD opportunity, at least at the onset? Thank you.

Thank you.

And I have nowhere.

Yeah Crazy if you could pretty answer the question on a sign up for a little more color.

Absolutely. So chasing you asked to the 5 million, it's a pair of demand numbers. So the answer is no.

5 million represents.

Actually revenues from <unk> into the channel in particular, it represents net revenues, which is orders minus the 18.

Which is 13% net all at the <unk> incentives you know commission. So it's really appearing <unk> number into the channel the difference between the channel inventory that demand number is is the gap. So this is not at the man number is a net exactly number.

Operator: Yeah.

Peony: Thank you, Jason, for the question. I'm going to ask Peony to comment on our publication strategy. We are excited about the publication planning, what we're trying to do this year. And then I'm going to ask Chris to give us some more color on China.

The second question casing I believe he asked is whether this represents more <unk>.

Peony: Yes, I am very excited about the upcoming publication plan. We could, I dare say that we are data-rich, and we're working very closely with our two partners, Astellas and AstraZeneca, to submit our Phase 3 individual studies, as well as pool efficacy and safety manuscripts for publications over the coming months. We also plan to submit a number of extracts to ASN, which will be held in October of this Stay tuned. Thank you.

So what we have seen so far is is very consistent with what we can set to south.

In the long term at the M.B.D. market has more patient and we could have a significant impact is that patient populations because they're currently either not treated undertreated.

But that is a market we need to belt.

It's a substitution market, it's a very well established stands I don't care and treatment patent well either people are converting from state to compare it to his P.H. guys or instead of patients are standing which had <unk>.

We have seen adoption.

Oh, the patient types, which is humor dialysis pericardium analysis, and very encouragingly non dialysis.

Operator: Thank you, everybody. Thank you.

So the number he's saying in terms of revenue is shipped in from F. athlete into the channel based on demand from H.D.P.D. and and.

Operator: and I have a question.

Christine L. Chung: Chris, if you could please answer the question on China Pro with a little more color.

Yeah.

Christine L. Chung: Absolutely. So Jason, you asked if the $5 million is a pure demand number. So the answer is no.

If I great. Thank you.

Yeah, if I could just a compliment a beep US you know just on my head.

Christine L. Chung: The $5 million represents X factory revenues from FibroGen Beijing into the channel. In particular, it represents net revenues, which is orders minus VAT, which is 13% net. All distributor discounts, incentives, and commissions.

Responsibility for China, So well went out with Lily.

We'll be able to have basically a 30, you know access to 30% of the overall market opportunity.

Close in our D.L. listing.

Christine L. Chung: So it's really a pure net number into the channel. The difference between the channel inventory and the demand number is the gap. So this is not a demand number; it's a net X factory number. The second question, Jason, I believe you asked is whether this represents more DD versus NDD. So what we have seen so far is very consistent with what Enrique said just now.

I think is very significant so we we that's that's a great progress he used to used to take companies both energy at least in basically year, we'll be able to have meaningful Marketaxess go continued from China I think that's extremely.

Encouraging I do want to make sure there wasn't anything while the the the hobby or just the x. five or just sale.

So there's nothing I knew so when it comes to skulking on it that's talking about very normal for a quarter and I would say it will look like you do a few three months before we do in fact I'm <unk>.

Christine L. Chung: In the long term, the NDD market has more patients, and we could have a significant impact on that patient population because they're currently either not treated or undertreated. But that is a market we need to build. For DD, it's a substitution market. It's a very well-established standard of care and treatment pattern where either people are converting from standard of care to HIF-PHIs, or incident patients are starting with HIF-PHIs. We have seen adoption across all the patient types, which is hemodialysis, peritoneal dialysis, and, very encouragingly, non-dialysis. So the number you're seeing in terms of revenues is shipped from our factory to the channel based on demand from HDPD.

Pretty thank you.

Thank you and our next question comes from Adam Wash <unk>. Your line is open.

Hi, Thanks for taking my question is this is adamant harmful Adam fourth one on Kobe 19.

We know they're published studies showing that Kobe 19 patients.

Even those who have recover all suffer from lung damage, including fibrosis.

So do you have any plans to eight or 10 revenue map or other pipeline assets is is Kuwait coding 19 basis and I'll have a full of if I may.

Christine L. Chung: Uh, if I, uh...

Operator: Thank you.

Enrique A. Conterno: If I could just compliment a bit, as you know, Jason, I had responsibility for China as well when I was at Lilly, to be able to have basically 30%, you know, access to 30% of the overall market opportunity post NRDL list. I think it's very significant. So, we, that's great progress. It used to take companies on the post-NRGO list basically years to be able to have meaningful market access opportunities in China. I think that's extremely encouraging. I do want to make sure there wasn't anything while the $5 million was just the ex-FibroGen cell.

Yeah. Thank you for your question one L.S. to comment, but just we are planning to study from <unk> hospitalized patients would go up in 19.

We see two potential applications.

<unk> setting to improve oxygenation and also in the Postacute setting.

Ameliorate lung type Ross is I'm going to now area to make a few more call me. A reason why we are excited about these additional opportunity to be able to help patients would cover 90.

Thank you for your cold So I <unk>.

Enrique A. Conterno: Net Sales. There's nothing unusual when it comes to stocking. Stocking was very normal for the quarter. And I would say as we look at Q2, Q3, and Q4, we do expect a meaningful ramp-up.

We are looking at these studies currently in we discussing this is studies with regulators I tries to F.D.A.

European regulators, we are moving forward, we should planning for these studies.

Operator: Great, thank you. Thank you. And our next question comes from Adam Walsh with Stiefel. Your line is open.

The difference is I was renewed days to to stages hope that go with 19 acute phase the first 15 days.

Operator: Hi, thanks for taking my questions. This is Adam. First one on COVID-19. We know there are published studies showing that COVID-19 patients, even those who have recovered, have suffered from lung damage, including fibrosis. So do you have any plans to explore time travel map or other pipeline assets in this COVID-19 patient? And I have a follow-up, if I may.

And the the residual pays.

I could face is that is a.

Big.

Lack of oxygen nation, which is is it was important part that is leading to a lot of difficulties in treating these patients.

Oh <unk> can have some ER affect we have a some data that to show that as we can affect the leakage at the level of defended vessels and could reduce the email and might facilitate oxygen missions.

Enrique A. Conterno: Yeah. Thank you for your question, Adam. I'm going to ask Elias to comment, but just...

In the long term, so that to D.C. patient to showing his children lung fibrosis and lung disease.

Enrique A. Conterno: We are planning to study panbrevimab in hospitalized patients with COVID-19.

Specific the up there are a acute respiratory distress syndrome.

Enrique A. Conterno: and we see two potential applications, in the acute setting to improve oxygenation, and also in the post-acute setting to ameliorate lung fibrosis. I'm gonna ask now, Elias, to make a few more comments or reasons why we are excited about this additional opportunity to be able to help patients with COVID-19.

And I guess, we have <unk> good effect on fibrosis.

I know, we believe that is potentially.

C.T.T.F. is.

<unk> is affecting fibrosis, which we knew what to say.

Our.

Tradition, and do so fibrosis.

The two weekend slowed down or stop progression over the fibrous.

Elias: Thank you for your call. As Enrique is saying, we are currently looking at these studies, and we're discussing these studies with regulators such as the FDA and other European regulators. We are moving forward with the planning for these studies. The difference is, as we know, there are two stages of COVID-19, the acute phase, the first 15 days, and the residual. And the acute phase is that it's a, um.., big lack of oxygenation, which is his an important part that is leading to a lot of difficulties in treating these patients. However, Revlimab can have some effect. We have some data that show that we can affect the leakage at the level of the vessels, and that could reduce the edema and might facilitate oxygenation.

And we are planning for.

To discuss their studies soon and play to move forward with them.

<unk> well that's one earlier this week a competitor disclosed this upper bombs <unk> 1.25.

Which is agreed by the F.D.A.

So wait a few <unk> they.

Do you hold you to the same standard for review and approval.

Thank you.

Yeah. Thank you I I will try to answer that pretty quickly I think we have a C.D.'s before we feel that the overall cardiovascular data that we basically have them both D.D.N.N.D.D. quite compelling.

And we we feel <unk> a I'm in Boston.

Elias: In the long term, sir, that this patient is showing is the cure for lung fibrosis and lung disease, specifically after the acute respiratory distress syndrome. In IPF, we have shown our good effect on fibrosis. And we believe that potentially, if CTGF is similarly affecting fibrosis, which we know it is from our radiation-induced lung fibrosis, we can slow down or stop that progression. And we are planning to discuss these studies soon and planning to move forward with them.

A benefit risk ratio.

As we've stated before it questions about Noninferiority will be part of a review the solution for rocks and do stuff, but we feel very coffin them. So what are we have been able to show in the <unk>.

Thank you.

Q.

Yeah.

Thank you and our next question comes from Darren rubber with Cowan Your line is open.

Yeah, Hi ends and thanks for taking my question, then couldn't Grad Sunshine I mean, it looks like it's off to to really terrific start.

I have a quick question relating to maybe just your thoughts and I don't know if you can comment a little bit ahead into the U.S. launch you know early next year.

Operator: Great, great. My next one: earlier this week, a competitor disclosed its upper bound of

The Dallas is setting and specifically with the benefit of <unk> with the damp drugs like rocks should the you know once included.

Operator: of a non-inferiority margin of 1.25, which is agreed by the FDA. So we assume the agency will hold you to the same standard for review.

<unk> use earlier I think it was last week engine noted that <unk>.

<unk> is decent up taking small and sort of medium size dialysis clinic, but much face much bigger headwind sort of really getting into the V. then presenting his.

Enrique A. Conterno: Yeah, thank you. I will try to answer this pretty quickly. I think we have stated this before. We feel that the overall cardiovascular data that we basically have on both DV and NDV is quite compelling, and we feel that RoxaDusta has an important benefit-risk ratio. As we've stated before, questions about non-inferiority will be part of a review decision for RoxaDusta, but we feel very confident in terms of what we have been able to show and the benefit-risk profile that the product has. Thank you. Thank you.

Thoughts about sort of how would you tackle that to make walks or sort of more attractive for them and then have a quick follow up as well.

Yeah.

Thank you I think thank you for your question clearly, but that's all for 15.

An incentive to to make sure that.

Innovative products are included a spiral the treatment protocol for.

Let's see centers.

I think it's designed for a product so success lots of good stuff.

Just to maybe speak a little bit of how about the process. Once we receive approval we would have to submit for.

To be reimbursed Thunder. This system. This so that the system, we expect that within three months, we will be able to get that designation.

Operator: Thank you. And our next question comes from Yaron Werber with Cowen. Your line is open.

And clearly we we think about that just like we will be preparing for any launches clearly in this particular case. The large dogs. These organizations are key in terms of their adoption and you can be reassured the we <unk> working closely.

Operator: Yeah, hi, and thanks for taking my question. And congrats on China. I mean, it looks like it's off to a really terrific start.

Enrique A. Conterno: I have a quick question relating to maybe just your thoughts, and I don't know if you can comment a little bit ahead of the US launch, you know, early next year, in the dialysis setting, and specifically with the benefit of Tadapa. With Tadapa, drugs like Roxa should, you know, once included, have a financial incentive to get used. Earlier, I think it was last week, Amgen noted that Parsibiv has seen a decent uptake in small and sort of medium-sized dialysis clinics but faced much bigger headwinds sort of really getting into DaVita and Fresenius. So thoughts about sort of how would you tackle that to make Roxa sort of more attractive for them? And then I have a quick follow-up as well.

With them to ensure that that we can have the very best adoption possible I mean sure that innovations are included in the in the treatment of patients in the Dallas centers and that is included fast.

So I I I can speak for other companies, but I feel good about the plans <unk> solidifying those those plans.

No.

Okay at least another question.

Sometimes is here and I think maybe you touched upon this do you have plans to release the data for the <unk> prevalent analysis on its own I mean, you've done really terrific job showing up into a thousand stayed on Oh hold Dallas is it just curious about the prevalent Dallas is is is accounted for about 80% of of patients in the market. Thank you.

Enrique A. Conterno: Yeah.

Enrique A. Conterno: Thank you. I think Tadapa offers, I think, incentives to make sure that innovative products are included as part of the treatment protocol for dialysis centers, and I think it's designed for a product such as Roxadusta.

Yeah, I'm going to ask the only two.

Who addressed a question I assume if he's talking about the.

Enrique A. Conterno: Just to maybe speak a little bit about the process. Once we receive approval, we will have to submit claims for reimbursement under this system, this TADAPA system. We expect that within three months, we will be able to get that designation. And clearly, as we think about that, just like we will be preparing for any launches, clearly, in this particular case, the large dialysis organizations are key in terms of their adoption, and you can be reassured that we are, and AstraZeneca is working closely with them to ensure that we can have the very best adoption possible and ensure that innovation is included in the So I can't speak for other companies, but I feel good about the plans and how we're solidifying those plans now.

Stable dollars is beyond me I need for what our plans when it comes to reducing the particular data.

Operator: Okay. Another question.

Yes, I mentioned art art insist then dialysis data also contains a.

Prevalent dialysis data in that.

<unk> instead that unless the first four months, that's the entry into the study and patient continue receiving treatment and so they aren't a prevalent patience and I've I've mentioned earlier that.

We have look at the patients who the staple dialysis saw the prevalent dialysis patient slipping on dialysis for for more than a four month at the time that they enter the our face to study and and we we are very comfortable with.

Advocacy and the safety data in that subgroup and and that's the the results that's not change our conclusion or confidence up our product and they're.

Peony: It sometimes is here, and I think maybe you touched upon this, do you have plans to release the data for the prevalent dialysis on its own? I mean, you've done a terrific job showing us the incident dialysis data and overall dialysis. I'm just curious about the prevalent dialysis as it accounts for about 80% of patients in the market.

It is very likely that we will we've made a share this data and I wanted to remind ourselves that that was not necessarily a that that analysis, let's not a pre specify analysis and and so we are is still comfortable with it.

Peony: Thank you.

Peony: I'm going to ask Peony to... to address the question. I assume he's talking about the... Stable the house is Peony and if what are our plans when it comes to releasing that particular data?

And the <unk> <unk> to keep in mind is that the overall beta overall by Alice says, which was supposed to pre specified a analysis and that we have already disclosed that and and we it to rate that the.

Peony: Yes, as I mentioned, our incident biolysis data also includes prevalent biolysis data.

86% of the patients who start dialysis heck not had receive any isa treatment <unk>.

And therefore, I insist then dialysis, where we we take those patients after the within the first four months to add into the study and we consider that data to be a highly relevant.

And we believe that we may have to a lot just instead, then dialysis patient pool in C.K.D.N. EEMEA programs.

I'm, sorry, and make it did you want to ask something.

Peony: the time that they enter our phase three study, and we are very comfortable with efficacy and the safety data in that subgroup, and that the results do not change our conclusion or confidence about our product. It is very likely that we may share this data, and I wanted to remind ourselves that that analysis was not a pre-specified analysis, and so we are still comfortable with it. And the most important to keep in mind is that the overall data, overall dialysis, which was the pre-specified analysis, and that we have already disclosed that. And we iterate that 86% of the patients who start dialysis have not received any ESA treatment for their anemia. And incident dialysis, where we take those patients within the first four months into the study, and we consider that data to be highly relevant. And we believe that we may have the largest incident dialysis patient pool in CKD anemia programs.

Yes. Thank you for you on the I the only thing that I wanted to add young was you talked about the same data is being plenty per cent of the market I I think.

That's correct for the first year, right, you're thinking of but unfortunately, but mortality or patients in Dallas very high so <unk> a <unk>.

He brought up that these differentiated <unk> is given that it's a natural born for three but the fishing when it comes to a meeting and starting dialysis would be we found is particularly important.

In order to do a half breathless for for for the treatment I, We we release Iraq, So do studies uniquely.

Going to be uniquely positioned thank you.

Thank you.

Thank you and our next question comes from Paul <unk> with Goldman Sachs. Your line is open.

Oh, Thank you in in high everyone, a hooker doing well and thanks for taking our questions. Maybe my my first question is her penny and with regard to the double blind portion of the phase three M.D.S. trial.

Can you maybe just comment on you know are you, saying you know thinking about any potential in <unk> timeline.

Given that the patients you know has to be condition for the M.D.S. treatment before potentially receiving rock climbing and then then I had a follow up on Europe.

Okay, but.

Go ahead.

Yes, I want it to clarify that I'm like <unk>. Another plot out a trial in terms of tries designs R. and D.S. trial includes Ah patients who are.

Peony: I'm sorry, Enrique. Did you want to add something?

Enrique A. Conterno: Yes, thank you, Peony. The only thing that I wanted to add was you talked about instant dialysis being 20% of the market. I think that's correct for the first year, right?

Enrique A. Conterno: You're thinking of, but unfortunately, the mortality of patients in dialysis is very high. So having a product that is differentiated in instant dialysis is given that it's a natural point for a treatment decision when it comes to anemia starting dialysis. We found it particularly important.

Treatment naive and those who have failed E.S.A.

And.

And then we are also includes patients who are wearing central blast positive trend setter and brings central blast a negative the trial if it global study and includes up studies sites and patients into.

Enrique A. Conterno: In order to have preference for that treatment, and we believe that Roxaduce is going to be uniquely positioned. Thank you.

Last m. in Europe.

I hope that answers and then then we have now at the top of blind placebo control portion of the study S. you alluded to I. Just wanted also remind ourselves that we have a share of.

Operator: Thank you. Thank you. And our next question comes from...

Operator: from Paul Choi with Goldman Sachs. Your line is open.

Operator: Thank you, and hi everyone. I hope you're doing well, and thanks for taking our questions. Maybe my first question is for Penny, and with regard to the double-blind portion of the Phase 3 MDS trial, can you maybe just comment on, you know, are you seeing, you know, thinking about any potential impacts on timelines, just given that the patients, you know, have to be conditioned for the MDS treatment before potentially receiving Roxa, and then I had a follow-up on that.

They're encouraging positive data.

Peony: Okay.

Off the open label second enough. This study at the American Society up Hematology in 2019.

<unk> I guess maybe <unk>.

I I guess, maybe to put it a different way p. any I'm just given the the situation with co bad and the risk to L.D.S. patients who have to go through chemotherapy or conditioning do you see any changes to the timeline for for your face three.

Peony: Are you ready? Go ahead.

Oh, Okay, now I want to.

Peony: Yes, I wanted to clarify that, unlike another product trial, in terms of trial design, the RMDS trial includes patients who are treatment naive and those who have failed ESA, and the... And then we also include patients who are ring sideroblasts positive and ring sideroblasts negative. The trial is a global study and includes study sites and patients in the US and Europe. I hope that answers your question. And then we are now at the double-blind placebo control portion of the study. As you alluded to, I just wanted to also remind ourselves that we had some very encouraging positive data from the Open Label segment of this study at the American Society of Hematology in 2009. I hope that answers the question.

Actually there is a little impact Ah knocked on our trial on our face retrial for the following a recent because the <unk> already transfusions dependent so they are.

Do need to be monitor and treated by their fixation or in other words that tells her to to the healthcare system.

And saw participation you're not trial.

Where we pulled fight and oral medication to reduce the risk of transfusions.

It's it's view you as you can think about this think about it this way that it could be a favorite <unk>. It patients could have less <unk> well require less transfusion that that can translate into less exposure best.

Does that make sense.

Yeah that that's helpful. Thank you and then regarding your you know as you're approaching the the N.A. here <unk> and this quarter and as you look maybe maybe on the forward here and think about commercialization just with regard to the different European views on using.

Using roxa and and the two populations. He may be comments on how you expect adoption might go there.

Peony: I guess maybe to put it another way, PNE, just given the situation with COVID and the risk to MDS patients who have to go through chemotherapy or conditioning, do you see any changes to the timeline for your Phase 3?

And yourself or or what your partner might might see as you think about the the early launch curve. There. Thank you very much.

Yeah.

Clearly a as as we have stated we are expecting filing in Europe. This second quarter as you know when he comes to Europe different markets behave differently. This is a a good question for.

Peony: Oh, okay. Now, I wanted to actually have a little impact on our trial, on our Phase 3 trial, for the following reason. Because the – now, the patients we enroll are already transfusion-dependent, so they are – they do need to be monitored and treated by their physicians, or, in other words, they're tethered to the healthcare system. And participation in our trial, where we provide an oral medication to reduce the risk of transfusion, is viewed – if you can think about this – think about it this way, that it could be favorable if Does that make sense?

Stellar, but we need to keep in mind that in some markers you can make the product you can touch the brought up right away liking, Germany. So for some other markets do it needs to go through be able to get some reimbursement. So there's gonna be a market by market decision and we look forward to helping as much as weak.

And fill up but they're really be drivers when it comes to commercialization of course in Europe.

Okay. Thanks for taking our questions.

Thank you and the next question comes from defy Yang with <unk>. Your line is open.

Hi, everyone. Thank you for taking the question does is Alex on for a <unk>.

Peony: Yes, that's helpful. Thank you. And then regarding Europe, you know, as you're approaching the MAA here in the coming quarter and this quarter, and as you look maybe ahead here and think about commercialization, just with regard to the different European views on using Roxa in the two populations, can you maybe comment on how you expect adoption might go there between yourself or what your partner might see as you think about the early launch curve there? Thank you very much.

I was wondering if she could come in a little bit on the N.D.D. setting in the U.S., specifically I was interested in.

Could talk about what is the standard of care. There you know however, E.S. says use today and what do you think of the benefits of having a placebo compared or in that setting.

Then along with that I was wondering whether or not you would expect a black box warning on approval. Thank you.

Very good.

I'm going to try to <unk> try to answer the last part of your question.

Enrique A. Conterno: Yeah, clearly, as we have stated... We are. [inaudible] at www.FibroGen.com.

I think what we said is that the data, though they are that we thought we'd we'd do not believe warrants a block bugs, but you see so decision for the regulators.

I'm going to a you only to to comment on N.B.B. and B. standard of care. Unfortunately.

Many patients are not reader for needed to do have I mean, yeah.

So there's an opportunity for to improve the treatment break, but you only you can talk about the sender, okay or maybe provide some color in N.D.B. in in the in the United States.

<unk>.

Operator: Okay, thanks for taking our questions. Thank you, and our next question comes from Steve Fai Yang with Mizuho. Your line is open. Hi, everyone. Thank you for taking the questions. This is Alex from DFAT.

Sorry, I, just thanks for reminding needs to be a muted oh. So thank you for the question. We do believe that non dialysis dependent a patient's anemia is is largely <unk> medical neat and this offers a great opportunity for it.

Operator: I was wondering if you could comment a little bit on the NDD setting in the U.S. Specifically, I was interested in if you could talk about what the standard of care is there, you know, how ESAs are used today, and what you think are the benefits of having a placebo comparator in that setting. And then, along with that, I was wondering whether or not you would expect a black box warning on approval. Thank you.

Roxadustat to improve care in this population what I mean by that is that because some fuck us cardiovascular safety concerned five E.S. say.

The <unk> treatment afar off a non dialysis patients with E.S.A. is limited to keeping hemoglobin less than 10 and and in the literature. This extensive evidence that keeping patients hemoglobin less than 10 associated.

Enrique A. Conterno: Very good. I'm going to try to pass this to Peony.

Peony: I'll try to answer the last part of your question. Clearly, I think what we said is that the data, the data that we have, we do not believe warrants a black box, but this is a decision for the regulator. I'm going to ask Joni to... to comment on NDD and the standard of care. Unfortunately, many patients are not treated for anemia that do have anemia. So, there's an opportunity to improve the treatment rate, but, Peony, you can talk about the standard of care and maybe provide some color in the United States. Hello, Peony.

Hi, I transcription risk and so there are it's well known that sends the maple change in east in 2011 that they're transfusion rate has gone up in the non dialysis patients along with the with deduction in the treatment rate Oh five.

Dialysis patients.

This is reflected by the U.S.I.D.S. data off only about 13.5% of the patients entering dialysis have been exposed to yeah say in the 12 month pyre. What this this translate I'm eight four roxadustat. This is the main reason that we have chosen placebo.

So as to compare it to our since no care in it it's the standard of care in the U.S. and you know faced we program we have demonstrated that a significant increasing hemoglobin a level compared to placebo and importantly significantly.

Peony: Sorry, I just, thanks for reminding me to be unmuted. So, thank you for the question. We do believe that non-dialysis-dependent patients with anemia are largely a medical need, and this offers a great opportunity for ROC to do that to improve care in this population. What I mean by that is that because of cardiovascular safety concerns about ESA, the treatment of non-dialysis patients with ESA is limited to keeping hemoglobin less than 10. And in the literature, there's extensive evidence that keeping patients' hemoglobin less than 10 is associated with higher transfusion risk. And so it is well known that since the label change in ESA in 2011, transfusion rates have gone up in non-dialysis patients, along with a reduction in the treatment rate of non-dialysis patients.

I reduced transfusion to only a about a third off off the placebo.

And in now <unk>.

And our treatments we <unk>.

He local low band at around 11, and this this was our treatment goal.

And so I'm also wanted to point out that placebo <unk> offers a ethics <unk>, it's that high bar for comparison for cardiovascular safety, because if one were to choose yeah say that as an agent.

Already has a box warning for cardiovascular safety, but we that placebo it's difficult standard.

With in comparison to placebo, we have demonstrate that.

I, we have demonstrated cardiovascular safety in a maze and point and mace plus and points.

Peony: This is reflected by the US RDS data, where only about 13.5% of the patients entering dialysis have been exposed to ESA in the 12 months prior. What does this translate? And for ROC to do that, this is the main reason that we have chosen placebo as the comparator since no care is the standard of care in the US. And in our phase three program, we have demonstrated a significant increase in hemoglobin levels compared to placebo, and importantly, significantly reduced transfusions to only about a third of the placebo. And now, into this. And our treatment resulted in hemoglobin at around 11, and this was our treatment goal. And so I also wanted to point out that a placebo comparator offers, as a comparator, a high bar for comparison for cardiovascular safety. Because if one were to choose ESA, that, as an agent, already has a box warning for cardiovascular safety. But placebo is the gold standard, and in comparison to placebo, we have demonstrated that we have demonstrated cardiovascular safety in the MACE Endpoint and MACE Plus Endpoint. Finally... Very good indeed.

Finally, very good yeah. Finally, our truck that's that's not we I <unk>, you know with I.N.I. program, 40% of our patients.

Why not I rarely plead that which is a requirement for E.S. say, so so not only are we able to a treat.

Treat the patients to have more they appeal that level of hemoglobin and reduced transfusion, we are going to be able to expand treatment to more patients. Even went there. They don't have as much I went underground.

Thank you.

Very good.

Thank you. Thank you for the only and I know that we are we have already extend their where.

Time, so I want to think everyone for joining a recall them for all of your support five or 10. Thank you. Thank you very much.

Ladies and gentlemen discussion because today's conference call. Thank you for participated and you may now disconnect everyone have a great day.

[music].

Peony: Yeah

Peony: Finally, in our program, 40% of our patients were not iron-repleted, which is a requirement for ESA. So not only are we able to treat patients to a more therapeutic level of hemoglobin and reduce transfusions, but we are going to be able to expand treatment to more patients, even when we don't have as much iron around.

Peony: Very good. Thank you. Thank you, Peony. And I know that we have already extended our time.

Enrique A. Conterno: So I want to thank everyone for joining our call and for all of your support of FibroGen. Thank you. Thank you very much.

Operator: Ladies and gentlemen, this concludes today's conference call. Thank you for participating, and you may now disconnect. Everyone, have a great day.

Operator: © BF-WATCH TV 2021. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. ... ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? [inaudible].

[music].

Operator: .. .. .. .. .. .. ....

[music].

[music].