Q4 2019 Earnings Call

Ladies and gentlemen, thank you for standing by and welcome to the Fibrogen fourth quarter and full year 2019 conference call. At this time, all participant lines on to listen only mode. After the speakers presentation there'll be a question and answer session. That's the question. During this session you need to press star.

Operator: Ladies and gentlemen, thank you for standing by, and welcome to the FibroGen fourth quarter and full year 2019 conference call. At this time, all participant lines are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you'll need to press star 1. Please be advised that today's conference is being recorded. If you require any further assistance, please press star 0. I would now like to hand the conference over to your speaker today, Mike Tung. Thank you.

One.

Please be advised to today's conference is being recorded if you acquire any further assistance. Please press star zero I'd now like the hand, the conference over to your Speaker today My tone. Thank you. Please go ahead Sir.

Michael Tung: Thank you, Justin, and good afternoon, everyone. Thank you for joining us on today's call to discuss FibroGen's performance for the fourth quarter and full year 2019. Today's call will be led by Enrique Conterno, our Chief Executive Officer. Enrique will be joined by Dr. Peony Yu, our Chief Medical Officer, and Ms. Chris Chung, our Senior Vice President of China Operations.

Thank you Justin good afternoon, everyone. Thank you for joining us on todays call. It just goes far buttons performance for the fourth quarter and full year 2019.

She's Colby led by Enrique Conterno, our Chief Executive Officer, Enrique will be joined by Dr. Peony, Yu, Our Chief Medical Officer, Ms., Chris Chung, our senior Vice President of trying to operations.

Enrique A. Conterno: Dr. Elias Khashoggi, our Senior Vice President of Clinical Development, Drug Safety, and Pharmacovigilance, and Mr. Pat Cotroneo, our Chief Financial Officer. Before we begin, I'd like to point out that we may make forward-looking statements regarding our business, including our collaborations with AstraZeneca and Astellas, financial guidance, The Initiation, Enrollment, Design, Conduct, and Results of Clinical Trials are Regulatory Strategies and Potential Regulatory Results, Our research and development activities, commercial results, and results of operations, risks related to our business, and certain other business matters. For risks and uncertainties regarding our business and statements made on the call today, as well as factors beyond our control that may cause differences between current expectations and actual results, we refer you to our annual report on Form 10-K for the fiscal year ended December 31, 2019, filed with the Securities and Exchange Commission.

Dr at least Krish Archie our senior Vice President of clinical development drug safety in Pharmacovigilance, Mr. Pat Cotroneo, our Chief Financial Officer.

Before we begin I'd like to point out that we may make forward looking statements regarding our business, including our collaborations with Astrazeneca and Astellas financial guidance.

The initiation enrollment design conduct and results of clinical trials, a regulatory strategies and pretend to regulatory results.

Our research and development activities commercial results and results of operations risks related to our business and certain other business matters.

The risks and uncertainties regarding our business and statements made on the call today as well as factors beyond our control that may cause differences between current expectations and actual results. We refer you to our annual report on form 10-K for the fiscal year ended December 31st 2019, coupled with the Securities Exchange Commission.

Enrique A. Conterno: 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. The webcast will be available for 30 days from today's date, and now I'd like to hand the call over to Enrique Conterno, our CEO.

Copies of these filings can be found in the Investor section of our website. We undertake no obligation to update any forward looking statement, whether as a result of new information future development or otherwise.

The format for todays call includes prepared remarks from provisions management team and then we'll open the lines to take your questions. A press release reporting or financial result in business update in a webcast of today's conference call. It can be found on the investors section of Fibrogen website at Www Fibrogen Dot com.

A webcast will be available for 30 days from today's date and now I'd like to hand to call the over to Enrique Conterno our CEO.

Enrique A. Conterno: Thank you, Mike, and good afternoon everyone, and welcome to our fourth quarter and full year 2019 earnings call. I'm excited to join the call today in my new role as FibroGen's CEO. I will start this morning by sharing a few thoughts about FibroGen and some initial impressions. I would also like to give you a sense of my initial areas of focus moving forward to deliver value to both patience and shareholders. FibroGen has two world-class scientific platforms, and our success comes from keeping patience and science at the core of what we do.

Thank you, Mike and good afternoon, everyone and welcome to our fourth quarter on full year 2019 earnings call.

I'm excited to join the call today in my new role that Fibrogen CEO.

I will start this morning by sharing a few thoughts about fibrogen on some initial impressions.

I'd also like to give you a sense of my initial areas of focus moving forward.

Deliver value to both.

Patience and shareholders.

Hydrogen has two world class scientific platform.

And our success comps from keeping patients and signs.

The core of what we do.

Enrique A. Conterno: Before I provide an overview of our progress, I would like to take this opportunity to acknowledge Tom Neff, the founder of FibroGen, who passed away last year. I thank him for his invaluable contribution to making FibroGen what it is today, and I look forward to honoring his legacy. I am highly appreciative of what the company has accomplished, and I look forward to continuing to build on this strong foundation. I have been spending time with my team, getting a clear sense of our strengths and challenges. And I've had the opportunity to hear from our shareholders and the broader investment community. My assessment is clear.

Before I provide an overview of our progress I would like to take this opportunity talk knowledge from that.

The founder of Fibrogen.

Who passed away last year.

Hi, thank him for he seemed valuable contribution.

[music], making fibrogen why did yesterday.

And I look forward to honor in his legacy.

I am highly appreciated how would the company has accomplished.

And I look forward to continuing to build on D. strong Foundation.

I have been spending time with my team getting a clear sense of our strengths and challenges.

And I've had the opportunity to hear from our shareholder something broader investment community.

My assessment is clear.

Enrique A. Conterno: FibroGen has a unique opportunity to leverage our world-class science in three areas of focus. Number one: Ensuring regulatory and commercial success of RoxaDustex. A Transformation of Medicine in Anemia Therapy, First, treating patients with chronic kidney disease, with great potential for expansion of treatment to other anemias. Number two.

Fibrogen has a unique opportunity to leverage our world class fines in three areas of focus.

Number one.

Insureme regulatory and commercial success of Roxadustat.

I professional Mediterranean and even a therapy.

First demonstrated in patients with chronic kidney disease.

Okay, great potential for expansion of Friedman <unk> anemia.

Number two.

Enrique A. Conterno: Accelerating the development of panbreblemaths in three high-value indications, idiopathic pulmonary fibrosis, a locally advanced and respectable pancreatic cancer, and Usain Muscular Dystrophy. And number three, maximizing our scientific and medical understanding of HIF and CTGF biology to provide future innovation. Before we move into our review of 2019, I'd like to provide some overall perspective on the Rochester-De

Accelerating that developing <unk> <unk>.

Three high value indications.

You do Patrick pulmonary fibrosis.

Locally advanced Unresectable pancreatic cancer.

I'm Duchenne muscular dystrophy.

And number three.

Maximizing our scientific and medical understanding of if I'm Cpgs biology to provide future innovation.

Before we move into our review of to soften a 19 I like to provide some overall perspective on the Roxadustat commercial opportunity.

Enrique A. Conterno: As anemia associated with chronic kidney disease, or CKD, continues to grow in worldwide prevalence, our work has never been more important. Anemia is common in patients with CKD stages 3 to 5, and the rate of anemia increases as CKD progresses. We estimate that there are 4.9 million CKD non-dialysis patients with anemia in the United States and that up to 50% may be addressable based on our expected label. Additionally, there are approximately half a million dialysis patients with anemia in the U.S. In 2019, we made significant progress with Roxadustat and achieved several critical advances, and we see continued momentum through 2020.

I saw anemia associated with chronic kidney disease or CKD continues to grow in worldwide prevalence <unk>.

Our work has never been more important.

Anemia is common in patients with secretly be stage three to five.

The rate of anemia increases that's CKD progresses.

We estimate that there are 4.9 million CKD non biopsy spaces with anemia in the United States.

On data up to 50%, maybe addressable based on our expected label.

Additionally, there are approximately half a million dialysis patients we didn't even here in the U.S.

In 2019, we made significant progress, we'd roxadustat and achieved several critical advances.

And we see continued momentum through Twentytwenty.

Enrique A. Conterno: Notably, the Roxa Dooster NDA was submitted in the U.S. for the treatment of dialysis-dependent and non-dialysis-dependent CKD anemia late last year, and the filing was recently accepted with a PDUFA date of December 20, 2020. In China... We and our partner AstraZeneca achieved rock-soluble inclusion in the National Reimbursement Scheme, an important milestone to accelerate market adoption and coverage. Initial upticks in hospital listings and demand are encouraging.

Notably the Roxadustat in VA was submitted in the U.S.

For the treatment of dialysis dependent on non diocese depend to CKD anemia late last year.

And finally was recently accepted with up to do for date of December 20 Twentytwenty.

In China.

We and our partner asked for Seneca achieved roxadustat inclusion in the national reimbursement Rock list.

An important milestone to accelerate.

Market adoption and coverage.

Michelle uptick of cost bid on listings on demand are encouraging.

Enrique A. Conterno: In Japan... Our partner, Astellas, received approval and launched Roxadusta, which has a trade name, a brand, for anemia in dialysis-dependent CKD patients and submitted a supplemental NDA for the non-dialysis indication this past January. Finally, in Europe, we and our partner Astellas look forward to the upcoming submission of Roxadustat for the treatment of dialysis and non Moving on to panbreplumab, a first-in-class antibody that inhibits the activity of connective tissue growth factor, a common factor in chronic fibrotic and proliferative disorders. In 2019, we initiated our Cepherus Phase III Clinical Program of Pumbrella Mapping Patients with Idiopathic Pulmonary Fibrosis. Last year, we also initiated our LAPIS Phase III clinical program of pandreblumab for the treatment of patients with locally advanced and respectable pancreatic cancer.

In Japan.

Our partner Seles received approval and launch Roxadustat.

We tried to trade name Brent so.

In anemia in dialysis dependent CKD patients and submitted the supplemental in D.A. for the non dialysis indication this past January.

Finally in Europe, we and our partner Stella.

Look forward to the upcoming submission of Roxadustat.

For treatment of dialysis and non dialysis dependent CKD anemia in the second quarter over this year.

Moving on to been breadth of them up a first in class antibody, which inhibits the activity of connective tissue growth factor I Coleman factoring chronic fiberoptic I'm proliferative disorders.

[noise] into something to 19, we initiated our suffers.

Phase three clinical program have been bread them up in patients with either biotic pulmonary fibrosis.

Last year, we also initiated our lobbies phase three clinical program up on bringing them up for the treatment of patients with locally advanced.

Unresectable pancreatic cancer.

Enrique A. Conterno: In Duchenne muscular dystrophy, we reported positive phase 2 data in 2019, and we expect to begin the Pivotal Phase 3 program in the second half of this year. All three of these indications are orphan diseases with limited treatment options. Accelerating enrollment in all of these Phase III programs is a top priority for me in 2020. We are in a position to create significant value for patients and shareholders. Our 2020 priorities are focused on getting Roxodusta approved in the U.S., advancing panbrevimab development, and finally, leveraging our expertise in both hypoxia-inducible factor and connective tissue growth factor biology to expand our pipeline of novel drug candidates. Now, I'll turn it over to Peony, who will give you a more in-depth discussion of RoxaDustep.

In Duchenne muscular dystrophy were reported positive phase two data into something to 19, and we expect to begin the people to phase three program and the second half of this year.

All three of these indications are orphan diseases.

We limited treatment options.

Accelerating enrollment in all of these phase three programs you set top priority for me in Twentytwenty.

We are in a position to create significant value for patients and shareholders.

Our 2020 priorities our focus on getting Roxadustat approved in the U.S. advancing been Revlimid development on a finally, just leveraging our expertise in both hypoxia inducible factor I connective tissue growth factor biology to expand our pipeline novel drug.

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Now I'll turn it over to Piani who'll provide you a more in depth discussion of Brooks said is that.

Thank you and Medicaid and good afternoon, everyone.

2019, with a great year for Roxadustat on I would like to review somewhat the highlights the Roxadustat M.D.A. was submitted to the FDIC for the treatment of anemia in both dialysis dependent CKD and non dialysis dependent CKD patients in December 2019.

Peony Yu: Thank you, Enrique, and good afternoon, everyone. 2019 was a great year for Roxaducet, and I would like to review some of the highlights. The Roxaducet NDA was submitted to the FDA for the treatment of anemia in both dialysis-dependent CKD patients and non-dialysis-dependent CKD patients in December 2019, and the FDA has accepted our NDA filing with a PDUFA date of December 20, 2020. Roxaducet was approved in China for the treatment of anemia in DDCKD patients at the end of 2018 and for the treatment of NDDCKD Chris will go into more detail later in the call when she provides an update on FibroGen China.

An F.D. has accepted our anda filing with the to the date of December 20 2020.

So does that was approved in China for the treatment of ammonia MPD CKD patients at the end of 2018 and for the treatment off and de de CKD anemia in August 2019.

Chris will go into more detail later in the call. When she provides an update on Fibrogen China.

In Japan Roxadustat was approved for the treatment of anemia in D.D. CKD patients in September 2019, and the supplemental M.D.A. Boy N D. D. A CKD was submitted this past January.

[noise] with positive momentum, we look forward to advancing Roxadustat in 2020.

Peony Yu: In Japan, Roxoducet was approved for the treatment of anemia in DDCKD patients in September 2019 and the supplemental NDA for NDDCKD was submitted this past January. With positive momentum, we look forward to advancing RoxaDUSTAT in 2020. In the U.S., we continue to support the FDA's review of our NDA and expect approval before the end of the year. There has been no indication at this time that the FDA will hold an advisory committee meeting, but we are preparing as if there were one. To optimize our business success in the U.S., we and our partner, AstraZeneca, continue commercialization preparation to pave the way for Roxaducept to become accessible to patients, with a robust efficacy and safety profile demonstrated in our large phase three program of over 8,000 patients.

In the U.S., we continue to support the FDIC with you offline, India and expect approval before the end of the year.

There has to be no indication at this time DFT It will hold and Advisory Committee meeting, but we are preparing ask if there were one.

To optimize our business. So says in the U.S., we and our partner Astrazeneca continue commercialization preparation to pave the way for Roxadustat could become a sensible to patients.

With the robust efficacy and safety profile demonstrate it you nod large phase three program of over 8000 patients. We believe roxadustat can potentially better address CKD anemia them. What is currently available to CKD patients on dialysis and does not on dialysis.

Yes.

So first summarize key positive.

Efficacy and cardiovascular safety results from the over 3800 patient pool, Oh, Hi, Alex is dependent patients, where roxadustat was compared to you put an alpha.

Peony Yu: We believe Roxadufec can potentially better address CKD anemia than what is currently available to CKD patients on dialysis and those not on dialysis. I shall first summarize key positive efficacy and cardiovascular safety results from the over 3,800 patient pool of dialysis-dependent patients where Roxadufec was compared to Epoetum Alpha, and patients had an average treatment duration of 1.8 years. As reported at the ASN meeting, in dialysis patients, Roxifusa met the primary efficacy endpoint with a larger hemoglobin increase than Ipoatin Alpha in each of the three pivotal studies and in the pool analysis, while mean achieved hemoglobin levels were within the intended range. Roth concluded that treated patients had lower transfusion risk than EPO patients while lowering MACE plus risk in the dialysis patient pool.

Anticipation hottie average treatment duration off 1.8 years.

As reported at the U.S.N. meeting in dialysis patients Roxadustat met the primary efficacy endpoint.

With larger hemoglobin increased sand you poets an alpha <unk>.

In each of the three pivotal studies and the pool analysis.

While mean achieve hemoglobin levels were within the intended range.

[noise] wants to do that treat the patients had lower transfusion with then you Paul patients, while lowering mace plus service in the dialysis patient pool.

Notably unlike Isa roxadustat maintain efficacy without increasing those requirements in the presence of inflammation importantly, less Ivy I haven't supplementation once we acquire what the blocks that then with you Paul.

Within the dialysis patient population, we are particularly excited about the cardiovascular safety would fall.

Peony Yu: Notably, unlike ESA, Roxeduce maintained efficacy without increasing those requirements in the presence of inflammation. Importantly, less IV iron supplementation was required with Roxeduce than with EPO. Within the dialysis patient population, we are particularly excited about the cardiovascular safety results in the Incident Dialysis Subpopulation. These patients entered the study during the first four months of dialysis initiation and had an average treatment duration of one and a half years. We enrolled over 1,500 incident dialysis patients in this program, the largest in this population ever conducted.

Off the incident dialysis subpopulation these patients into the study during the first four months all dialysis initiation and had an average treatment duration, the one and a half years. We go over 1500 incident dialysis patients in this program the largest in this population ever.

Conducted.

Here, we demonstrate that a meaningful reduction in cardiovascular safety with that's roxadustat tree. The incident dialysis patients had a 30% lower amazed with and a 34% low what makes plus with such an important alpha to treat patients.

We believe the high with incident dialysis, a population is the right a and most appropriate setting for comparison of roxadustat versus the potent alfonsin's most patients like Isa naive Pio to study entry.

Peony Yu: Here, we demonstrated a meaningful reduction in cardiovascular safety risk as Roxas DUSAT-treated incident dialysis patients had a 30% lower MACE risk and a 34% lower MACE plus risk than Ipotent Alpha-treated patients. We believe the high-risk incident dialysis population is the right and most appropriate setting for comparison of Roxas DUSAB versus the potent alpha since most patients are either naive prior to study entry. Now, moving on to our non-dialysis program, I will summarize key positive efficacy and cardiovascular safety results from the over 4,200 pool of non-dialysis dependent patients where Roxoducet was compared to placebo. As a reminder, the vast majority of NDD patients in the U.S. receive no ESA treatments, especially after the ESA label changed over the period of 2007 to 2011, and placebo control is the preferred standard for safety comparison.

Now moving onto our non dialysis program I will summarize key positive efficacy and cardiovascular safety results from the over 4200 pull off non dialysis dependent patients, where roxadustat was compared to placebo.

That's a reminder, the vast majority of M.P.D. patients in the U.S. received no easy so treatment.

Especially after the Isa label change over the period off 2007 to 2011 and placebo control is the pre first standard for safety comparison.

In MDD patients Rosset dues that was superior to plus people in the primary efficacy endpoint up mean, changing hemoglobin levels from baseline and significantly reduce transfusion miss compared to placebo.

Because roxadustat is conducive to Iran. Mobile mobilization, we demonstrate the roxadustat efficacy in patients with lower.

I haven't stores that we acquired for you so.

Peony Yu: In NDD patients, Roxodustat was superior to placebo in the primary efficacy endpoint of mean change in hemoglobin level from baseline and significantly reduced transfusion risk compared to placebo. Because Roxodustat is conducive to iron mobilization, we demonstrate its efficacy in patients with lower iron stores than required for ESA. Forty percent of the patients in our Phase III NDD studies had baseline iron stores below the minimum required for treatment with ISSA and demonstrated that the hemoglobin response to roxiducet was similar to that of patients with iron repletion, with respect to cardiovascular safety. Roxoducet was comparable to placebo in risk of MACE and MACE+, while achieving a mean hemoglobin level of 11 grams per deciliter.

40% of the patients enough faced we NBP studies have baseline, Iran sports below the minimum required for a treating for treatment with Isa and demonstrate the hemoglobin response to Roxadustat was similar to the adult patients with Iran Repletion.

With respect to cardiovascular safety.

Lots to do that was comparable to placebo yris up amaze amazed plus while achieved a mean hemoglobin level of 11 grams per deciliter.

With this favorable efficacy and safety profile. In addition to the convenience of oral dosing, we believe roxadustat can potentially overcome a number of hurdles off he says and expand anemia treatment in MDD patients.

Christine L. Chung: With this favorable efficacy and safety profile, in addition to the convenience of oral dosing, we believe Roxodilstat can potentially overcome a number of hurdles in ESUS and expand anemia treatment in NDD patients. Beyond CKD, we continue development of Roxaduceptin for the treatment of anemia associated with myelodysplastic syndrome, and for chemotherapy-induced anemia while evaluating it for additional diseases. Our vision for Roxodustat is to become the standard of care for anemias broadly. Last December, we presented positive results from the open-label portion of the Phase 3 global study evaluating Roxasdustat for treatment of anemia in MDS patients at the annual American Society of Hematology meeting. In 2019, we also initiated a Phase II study in chemotherapy-induced anemia, which represents a large patient population whose anemia is often left untreated today, to make Roxoducet available to the rest of the world.

Beyond CKD, we continue development roxadustat for the treatment of anemia associated with Myelodysplastic syndrome.

For chemotherapy induced anemia, while you're evaluating for additional diseases, our vision for Roxadustat.

As to become the standard of care for anemia brought the way.

Last December we present the positive results from the open label Porsche and not the phase three global study evaluating roxadustat for treatment of anemia in Mds patients at the annual American Society of Hematology meeting.

In 2019, we also initiated a phase two study in chemotherapy induced anemia.

See I a represents a large patient population, whose anemia is often left untreated today.

To make roxadustat available to the rest of the world our partner Astra Zeneca in collaboration with our team. It's the emitting marketing application of Roxadustat for CKD anemia in a number of countries.

Christine L. Chung: Our partner, AstraZeneca, in collaboration with our team, is submitting marketing applications for Roxoducet for CKD anemia in a number of countries. We've already submitted to Canada, Mexico, and several Asian countries. It is great to see all this progress in a month following the three prominent scientists, including Dr. Bill Kalin, our longtime advisor and collaborator, were awarded the 2019 Nobel Prize in Medicine for discoveries in oxygen sensing, which serve as the important scientific basis for the development of rocks to do that. We appreciate the medical community's strong support for Roxa Ducet and look forward to the opportunity to work with physicians, nurses, and patients to improve anemia care globally. I would now like to turn the call over to Chris Chung, who will discuss recent developments in China.

We've already submitted to Canada, Mexico, and Central Asian countries.

It is great to see all this park west in the month following the three palm and scientists, including bump to built Halen, a long time adviser and collaborator well awarded the 2019 Nobel Prize in medicine for discoveries in oxygen something which.

Served as the important scientific basis for the developmental roxadustat.

We appreciate the medical communities strong support for Roxadustat and look forward to the opportunity in working with physicians nurses and patients to improve.

Mimi a care globally.

I would now like to turn the call over to Chris Tom who will discuss the recent developments in China.

Thank you Piani.

Christine L. Chung: Thank you, Peony. 2019 was also a milestone year for FibroGen China. Roxoduce was launched in the middle of last year, and this established FibroGen as a commercial stage company.

2019 was also a milestone year for Fibrek in China.

Roxadustat was launched the middle of last year.

This established Fibrogen assay commercial stage company.

Christine L. Chung: Beyond FibroGen, it was a historical milestone in global drug development in that, for the first time in history, China was the first launch country for a first-in-class drug. Roxadista was added to the 2019 National Reimbursement Drug List, or NRDL, effective January 1, 2020. Reimbursement by the government greatly reduces the co-pay portion for patients and is critical to market adoption. As Peony already stated, in August, the NMPA approved Roxadustat for non-dialysis. Roxadustat has the unique benefit of oral administration, and we believe the NDD approval will greatly extend the reach of Roxadustat to patients in need beyond dialysis. FibroGen earned $22 million in milestone payments from AstraZeneca triggered by the NRDL inclusion.

Beyond Fibrogen it was historical milestone in global drug development in that for the first time in history.

China was the first launch country for a first in class drug.

[noise] Roxadustat was added to the 2019 national reimbursement drug list or an ideal effective January 1st 2020.

Reimbursement by the government greatly reduces the co pay portion for patients and is critical to market adoption.

S.P. only already stated in August the N.P.A. approved roxadustat for non dialysis.

Roxadustat has the unique benefits of oral administration, and we believe the MDD approval will greatly extend the reach of roxadustat to patients in need beyond dialysis.

Fibrogen earned $22 million, a milestone payments from Astra zeneca triggered by the end RTL inclusion.

Christine L. Chung: Looking forward to 2020 with reimbursement for Roxaduce that is now available on a national basis. Our top priority is hospital listings. A drug needs to be listed in a hospital formulary before it can be dispensed to 90 percent of the potential market represented by government hospitals. This process is done on a hospital-by-hospital basis. Given the transformative nature of Rakhsadizdat, an equally important priority for us is physician education. As for the market potential in China, we believe there are over 600,000 dialysis patients in China, making this the largest dialysis population in the world. It is expected to continue to grow in the foreseeable future at a low double-digit rate.

Looking forward to 2020 with reimbursement for Roxadustat now available on a national basis.

Top priority it's hospital listening.

Hey drug needs to be listed in the hospital formulary before it can be dispensed for 90 plus percent Oh, the potential market represented by government hospitals.

This process is done on a hospital by hospital basis.

Given the transformative nature of Roxadustat and equally important priority for us is petition education.

As for the market potential in China, We believe there over 600000 dialysis patients in China, making this the largest dialysis population in the world.

It is expected to continue to grow in the foreseeable future at a low double digit rate.

We estimate the addressable population in non dialysis with anemia to be around two to 3 million patients.

Khalil Fenina: We estimate the addressable population in non-dialysis with anemia to be around 2 to 3 million patients. Anemia treatment has historically been limited to oral ion, intravenous ion, and ECI. We believe the oral nature of roxidustat and the absence of a box warning could greatly expand the addressable NDD patient base, as well as increase treatment rates and persistency in this population. Coronavirus continues to be an evolving situation in China and beyond. While ensuring the health of our employees, our top priority is making sure that Roxidustat is available to patients. As of today, both our drug product facility in Beijing and our API facility in Tanzu have returned to operations after a short period of shutdown. Our ability to conduct in-prison visits to physicians and hospitals continues to be affected, and we will continue to monitor and assess the situation closely. I will now turn the call over to Elias Khashoggi, who will provide an update on the PREMREVIMENT program.

And you need treatment has historically been limited to oral iron.

Intravenous iron and he says.

We believe the oral nature of Roxadustat and the absence of a box morning could greatly expands the addressable NBD patient base Isabel S increase treat mid rate and persistency in this population.

[noise] Corona virus continues to be at an evolving situation in China and beyond.

Well in Sri the health of our employees our top priority is in making sure that roxadustat is available to patients.

As of today, both our drug product facility in Beijing, and Apiay facility in Tom's, though have returned to operations after a short period of shutdown.

Our ability to conduct imprisoned visits to physicians and hospitals continues to be affected.

And we will continue to monitor and assess the situation closely.

I will now turn the call over to at least for Shockey, who will provide an update on the prime rather that program.

Thank you, Chris and good afternoon.

Khalil Fenina: Thank you, Chris, and good afternoon. I would like today to review our accomplishments with PAM Revlimab over the last year and update you on our plan for 2020. In 2019, the FDA and the EMA both granted orphan drug designation for pamrevlumab in the treatment of Duchenne muscular dystrophy, also known as DMD. This strengthens our commitment to developing our novel antibody as a potential new treatment option for those suffering from this debilitating and progressive disease. We have begun enrollment in our Pivotal Phase III trial in both idiopathic pulmonary fibrosis and pancreatic cancer. These studies are Zephyrus, a Phase III randomized, double-blind, placebo-controlled study evaluating PAM-Revlimab in IPF, and Lapis, a Phase III randomized, double-blind, placebo-controlled study in locally advanced and resectable pancreatic cancer.

I would like today to review our accomplishment was pamrevlumab over the last year and update you on our plan for Twentytwenty.

And 2019, the F.D. and that Yeah me, both granted orphan drug designation for Pamrevlumab in the treatment of the Shen muscular dystrophy.

Also known as the M D.

This is strengthened our commitment to four default being our novel antibody has a potential new treatment option for Joe's suffering from this debilitating and progressive disease.

Also in the last year.

We began enrollment in our pivotal phase three trials.

In both idiopathic pulmonary fibrosis and in pancreatic cancer.

These studies are.

Zephyrus phase three randomized double blind placebo controlled study.

Evaluating pamrevlumab an IPO Jeff.

And a lot this phase three randomized double blind placebo controlled study and locally advanced Unresectable. Thanks, I guess.

In September of last year, let's hit the respiratory medicine.

Khalil Fenina: In September of last year, the Lancet Respiratory Medicine published our praise phase two study data in the IPF. The published data for this randomized, double-blind, placebo-controlled study showed that both, 1. The Decline in Force Vital Capacity Percent Predictor, And two, the proportion of patients with the disease progression were significantly lower in the PAM-REVLU-MAP group than in the placebo group and an accompanying editorial.

Publish our praise phase two study.

Data in IP, Jeff.

The published data for descend demise double blind placebo controlled study showed that both.

One the decline in forced vital capacity per cent predicted.

And to the proportion of patients with disease progression or significantly lower into Pamrevlumab group than in a placebo group.

And then accompanying editorial.

Dr. I told well self Royal Brompton Hospital wrote.

Khalil Fenina: Dr. Atul Wells of Royal Ponton Hospital wrote, "It is difficult to imagine a more encouraging Phase 2 trial. As we move forward with our Phase 3 program, we are gratified by the interest of our KOLs and Pam Revlimab as a potential new therapy for IPF. In 2020, we are planning to accelerate and expand the development of PAM review models."

It is difficult to imagine it more encouraging phase two trial.

As we move forward with our phase three program, we ought to gratified by the instead, so far care, what else and nipple my knowledge. It community have shown in Pamrevlumab as a potential new therapy for IP Jeff.

In Twentytwenty, we are planning to accelerate and expand developmental from revenue them up.

We are focused on accelerating enrollment of our ongoing Saphris phase three study and I T F.

Pat Cotroneo: We are focused on accelerating enrollment in our ongoing Zephyrus Phase III study in IPF and strengthening our regulatory submission. We now plan to add a second phase 3 study. This change will mitigate the risk of having a single study of approximately 560 patients. And now we plan to enroll approximately 340 patients in each of these two studies. The primary efficacy endpoint is going to be the change from baseline and force vital capacity of VC, and the secondary endpoints will include clinical outcomes of disease progression, patient-reported outcomes, and quantitative changes in lung fibrosis volume from baseline. Moving on to the LAPC Phase 3 trial, LAPIS, we will continue to activate sites in the U.S. and globally to expand and accelerate enrollment in this approximately 260 patient trial. In the second half of 2020, we also look forward to starting a Phase III trial evaluating pamrevlimab as a treatment for Duchenne muscular dystrophy. We are in discussions with the FDA and EMA to finalize the design of the program. I will now turn the call over to our CFO, Pat Catroneo, for the financial update. Pat?

And to strengthen our regulatory submission.

We now plan to add a second phase three study.

This change will mitigate the risk of having single study off approximately 560 patient.

And now we plan to enroll approximately.

340 patient and each of these two studies.

The primary efficacy endpoint and that is going to be the change from baseline and forced vital capacity a b C.

In the secondary endpoints would be will include clinical outcomes of disease progression.

Patient reported outcomes and quantitative changes in lung fibrosis volume from baseline.

Moving onto the L.A.P.C. phase three trial LAPIS.

We would continue to activate sites in the U.S. in globally to expand and accelerates enrollment.

Of disk approximately 260 patient trial.

In the second half of Twentytwenty. We also look forward to start to get phase three trial evaluating pamrevlumab.

It treatment for Duchenne muscular dystrophy.

We are in discussion with the F.D. and yeah made to finalize the design of the program.

I would turn now the called over to all our CFO baskets vornado for the financial update but.

Pat Cotroneo: Thank you, Elias. As announced today, total revenue for the quarter ended December 31, 2019, with $8 million, as compared to $108.1 million for the fourth quarter of 2018. The current quarter's revenue was made up of $43.2 million in license and development revenue plus $1.1 million in net product revenue, less an adjustment relating to API pricing for Japan, which I will describe momentarily. For the same period, operating costs and expenses were $108.4 million, and that loss was $98.1 million, for $1.12 per basic and diluted share, as compared to operating costs and expenses of $88.1 million and a net income of $21 Included in our fourth quarter 2019 revenue recognition methodology is a total of 22 million dollars in milestones associated with the inclusion of ROC's reduced debt to the China NRDL in December.

Thank you Alan Yes, as announced today total revenue for the quarter ended December 31, 2019 was $8 million as compared to $108.1 million for the fourth quarter of 2018.

The core quarter revenue was made up a $43.2 million in license and development revenue plus $1.1 million in net product revenue.

That's an adjustment relating to <unk> pricing for Japan, which I will describe momentarily.

For the same period operating cost and expenses, where 100, an $8.4 million and net loss was $98.1 million or $1.12 cents per basic and diluted share.

As compared to operating costs and expenses of $88.1 million and then net income of $21 million or 25 cents per basic share and 23 cents per diluted share for the fourth quarter last year.

Included in our fourth quarter 2019 revenue recognition methodology is a total of $22 million and milestones associated with the inclusion of Roxadustat to the China and RTL in December.

In the fourth quarter 2019, we recorded net product revenues of $1.1 million for Roxadustat sales in China.

In addition in the fourth quarter 2019, we reported a reduction of $36.3 million for commercial Apiay delivered to us down less than 2018.

Pat Cotroneo: In the fourth quarter 2019, we recorded net product revenues of $1.1 million for Roxadustat sales in China. In addition, in the fourth quarter 2019, we recorded a reduction of $36.3 million for commercial API delivered to Astellas in 2018, prior to approval and the establishment of the listed price in Japan. The original sale of API was based on an estimated list price, but the actual price was set by the Japanese Ministry of Health, Labor, and Welfare in Q4 2019.

Prior to approval and the establishment of the listed price in Japan.

The original see elevate P. I was based on an estimated listed price.

The actual price was set by the Japanese Ministry of Health Labor and welfare in Q4 2019.

Included in operating costs and expenses for the quarter ended December 31 2019.

Was an aggregate noncash portion totaling $22.1 million.

Which is $17.4 million was a result of stock based compensation expense as compared to aggregate noncash portion of $15 million of which $13.7 million was a result of stock based compensation expense for the same period in the prior year.

Pat Cotroneo: Included in operating costs and expenses for the quarter ended December 31, 2019, was an aggregate non-cash portion totaling $22.1 million, of which $17.4 million was a result of stock-based compensation expense, as compared to an aggregate non-cash portion of $15 million, of which $13.7 million was a result of stock-based compensation expense for the same period in the prior year. As stated in our Q2 2019 results, in accordance with U.S. GAAP. We recognized a total of $180 million, comprised of $50 million for an anticipated milestone for Masters Zeneca related to the filing of the USMDA, and $130 million in anticipated milestones from Astellas in connection with the EU MAA filing, when such milestone achievements become probable. As noted earlier on this call, our NDA submission was accepted for review by the FDA in February, and we expect the Astellas MA submission to occur in the second quarter of 2020.

As stated in our Q2 2019 results in accordance with U.S. gap, we recognized a total of $180 million.

Comprised of $50 million for an anticipated milestone from Astra zeneca related to the filing of the U.S. and da.

And $130 million in anticipated milestones from Stellus in connection with the E U M. A filings when such milestone achievements become probable.

As noted earlier on this call R. and D.A. submission was accepted for review by the F. T. A in February.

And we expect the a stellus M. A submission to occur in the second quarter of 2020.

Based on these milestones and our latest forecast data, we estimate or 2020, ending cash to be in the range of $720 million to $730 million.

Assuming U.S. and the approval in Q4 2020.

Looking ahead, we have a total of $425 million an anticipated milestones expected over the next 18 months.

Which includes the hundred $80 million of milestones on India in M.A. submissions already mentioned.

Pat Cotroneo: Based on these milestones and our latest forecast data, we estimate our 2020 ending cash to be in the range of $720 to $730 million, assuming U.S. NDA approval in Q4 2020. Looking ahead, we have a total of $425 million in anticipated milestones expected over the next 18 months, which includes the $180 million of milestones on NDA and MAA submissions already mentioned, plus $245 million of milestones on approvals and first sale The $245 million is essentially equally split between our anticipated NDA and MAA approval. As of December 31, 2019, FibroGen had $627.1 million in cash, restricted-time deposits, cash equivalents, investments, and receivables.

Plus $245 million, a milestones on approvals and first sale.

The $245 million is essentially equally split between our anticipated N D and M.A. approvals.

At December 31, 2019, Fibrogen had $627.1 million in cash.

Restricted time deposits cash equivalents investments and receivables.

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

In closing.

This is an exciting time for fibrogen.

Roxadustat is launching in China, Japan.

And it has been submitted in the U.S. kinda on other countries on soon in Europe.

We're committed to bringing pamrevlumab as a first in class and best in class.

New medicines to patients in three high value indications, namely idiopathic pulmonary fibrosis.

Locally advanced Unresectable pancreatic cancer and Dushane.

Muscular dystrophy.

We look to Reenergize, our research agenda to de lever on our unique scientific expertise or both hypoxia inducible factor on connective tissue growth factor biology to create a fulsome pipeline.

Enrique A. Conterno: Thank you, and I would now like to turn the call back over to Enrique.

Enrique A. Conterno: In closing, this is an exciting time for FibroGen. Roxadusta is launching in China and Japan and has been submitted in the U.S., Canada, and other countries and will soon be available in Europe. We are committed to bringing Pam Revlimab as a first-in-class and best-in-class new medicine to patients in three high-value indications, namely idiopathic pulmonary fibrosis. Locally Advanced and Respectable Pancreatic Cancer and Duchenne Muscular Dysfunction

Our next generation drug candidates.

We're in a strong financial position as Roxadustat sales ramp up.

With approximately $630 million in cash and another 425 million in anticipated Roxa do some of them payments expected over the next 18 months.

In addition.

We receive partner reimbursement for the development and commercialization of Roxadustat in all geographies outside China.

In China, we shared its expenses with extra Senate got 50 50.

Enrique A. Conterno: We look to re-energize our research agenda to deliver on our unique scientific expertise of both hypoxia-inducible factor and connected tissue growth factor biology to create a fulsome pipeline of next-generation drug candidates. We are in a strong financial position as RoxaDusta sales ramp up, with approximately $630 million in cash and another $425 million in anticipated RoxaDusta milestone payments expected over the next 18 months. In addition, we received partner reimbursement for the development and commercialization of Roxas Dustat in all geographies outside China. In China, we share these expenses with AstraZeneca 50-50. I want to thank our team here at FibroGen for their dedication to improving the lives of patients that we serve. I would also like to thank Jim Schenecter, who served as interim CEO and who will continue as chairman of the board. Now, I would like to turn the call back to the operator for questions.

I want to think our team here at Fibrogen for their dedication to improve the lives of patients that we serve.

I would also like to thank Dream Center.

Who served as interim CEO and who will continue as chairman of the board.

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

Justin.

Thank you as a reminder, asked the question you need to press Star one on your telephone. So withdraw your question press the pound Keith Please standby, we've compiled the Q and a roster and again if you'd like to ask a question that star one.

And our first question comes from Michael Yee from Jefferies. Your line is now open.

Oh, thanks, so much and ER, congrats and recap on Oh.

Well I'm not all the accomplishments recently two questions one on Pamrevlumab I thought it was quite notable you focused on accelerating IP asking pancreatic and just sort of the overall program. Maybe you could comment about specifically what you're doing to do that is that just site activation is that just more boots on the ground, maybe talk about that and whether you are.

Actually thinking to get an interim on resection late in pancreatic cancer and say 2021 is that is that much more milestones.

Operator: Justin? Thank you. As a reminder, to ask a question, you'll need to press star 1 on your telephone. To withdraw your question, press the pound key.

And now on Roxa My question, Yes.

There is obviously some competitors around you one of which will have phase three data coming up shortly maybe you could comment on what we should keep in mind on what you're looking for and how to put that into context I'm trying to be a lot of focus on that and comparing to your data. Thanks much.

Michael Jonathan Yee: Please stand by as we compile the Q&A roster. And again, if you'd like to ask a question, that is Star 1. And our first question comes from Michael Yee from Jeffries. Your line is now open.

Very good. Thank you Michael I'm going to ask a lead us to address the question on Pembrolizumab in terms of.

ER enrollment what actions are we taking the Leah and.

And also could we have a an interim Luke on both L. APC as well as I B F and I'm going to ask a then you'll need to address the roxa questions.

Enrique A. Conterno: Thanks so much, and congratulations, Enrique, on all the accomplishments recently. Two questions, one on Pam Revelman. I thought it was quite notable that you focused on accelerating IPF and pancreatic cancer and just sort of the overall program. Maybe you could comment about specifically what you're doing to do that. Is that just site activation? Is that just more boots on the ground?

Michael Thank you for your question. So first of all share for the IP. After study we are accelerating the site activation and new U.S. and not told into S. as it globally. So we are actively and I'm very aggressively.

Khalil Fenina: Maybe talk about that and whether you actually think you could get an interim on resection rate in pancreatic cancer and say 2021. Is that an achievable milestone? And then on Roxa, my question is, there are obviously some competitors around you, one of which will have phase three data coming up shortly. Maybe you could comment on what we should keep in mind or what you're looking for and how to put that into context. I'm sure there'll be a lot of focus on that and comparing it to your data. Thanks so much.

Submitting all our C.T. A's and starting our European sites it to be activated.

Digitally we are a in a more active contact with our side, who is our investigators and way automotive engage with our community that Pulmonology community and we ought to see if you can get a big interest stuff when might affect we are getting contacted but some of these sites asking.

I wish I bought a opening their sites for this study.

So this is Ed.

Khalil Fenina: Very good. Thank you, Michael.

First thing. So we are doing this time and as you heard that she's going to be again that the European studies at the second study is going to be activated.

Khalil Fenina: I'm going to ask Elias to address the question on the Pampreblo map in terms of... enrollment, what actions are we taking, Elias? And also, could we have an interim look at both LAPC as well as IPF? And I'm going to ask Peony then to address the ROCSA questions.

It is it's the second part of your question is so can you remind me pancreatic cancer or do you think you could get an interim on resection rate in 2021 shot at very reasonable or true there.

Yes.

So oh, we are similarly, we are I aggressively going after the sites in the way out rolling sites, we are subject to receive S.G. approval in Europe had the same time.

Khalil Fenina: Mike, thank you for your question. First of all, for the IPF study, we are accelerating site activation in the U.S., and not only in the U.S. but globally. So we are actively and very aggressively submitting all our CTAs and starting our European sites to be activated. Additionally, we are in more active contact with our sites, with our investigators, and we are more engaged with our community, the pulmonology community, and we are receiving a great interest. As a matter of fact, we are getting contacted by some of these sites asking us about opening their sites for this study. So this is a...

And we are pushing guys how hard that's a possible to enroll these patient as fast as possible.

Just a reminder, these patients is not pre screen.

Because you have to wait for the patient to be diagnose out and respectable locally advanced unresectable before they get treated if they are already treated they cannot be in this study.

So we are doing everything is possible that to able to achieve this milestones and we are pushing very hard to we expanded and increase the number of far side that the same time.

Khalil Fenina: The first things we are doing at this time, and as you heard, this is going to be, again, the European studies; the second study is going to be activated. The second part of your question is, can you remind me? For pancreatic cancer, do you think you could get an interim resection rate in 2021? Is that very reasonable or achievable?

Yeah, Michael maybe I can add we're not providing at this time timelines when it comes to a enrollment we intend to provide more detail timelines in the second half of this year for all of our trials when it comes to Pembrolizumab.

We are looking at the resection rates as a one of the possibilities for us to request a meeting with the F.D.A. for I'm accelerated approval and we'll provide more detail. Some died in the second half as this year.

Khalil Fenina: So, we are, similarly, aggressively going after sites in the way of rolling sites. We are starting to receive CTA approval in Europe at the same time. And we are pushing as hard as possible to enroll these patients as fast as possible. And just a reminder, this patient is not pre-screened because you have to wait for the patient to be diagnosed as unrespectable, locally advanced unrespectable, before they get treated. If they are already treated, they cannot be in the study. So we are doing everything possible to be able to achieve these milestones, and we are pushing very hard to expand it and increase the number of our sites at the same time.

Perfect perfect joining on Russia.

Okay.

I'm Mike. Thanks for the question. We are aware that there are a that's another half page I program that may be disclosing their face me data this year.

To address your question I wanted to two to remind ourselves that roxadustat is the only if the P.H.I. program that already demonstrated positive efficacy and safety data.

And so without seeing competitors data, it's difficult to compare who has spent a data.

And we know that in Tom when you can tell a clinical trial, especially in safety outcome trial, a one could ex expat a variety of outcome.

Yeah, we are Oh, we have demonstrated a very favorable benefit embraced the based show now however, I could comment on the phase three study design that we have a design a program to Oh, two demonstrates a safe teeth income Paris.

Enrique A. Conterno: Michael, maybe I can add, we're not providing timelines at this time for enrollment. We intend to provide more detailed timelines in the second half of this year for all of our trials when it comes to panbrevimab. We are looking at the resection rate as one of the possibilities for us to request a meeting with the FDA for an accelerated approval, and we'll provide more details on that in the second half.

Then to placebo, yes, and so with the hope and confidence of gaming a clean safety a label for non dialysis and then in ER and we in incident dialysis, which is a highly relevant in.

Cheating anemia in dialysis patients we have demonstrated a 30% reduction you may Swiss and they 34% reduction amazed plus RIS.

Enrique A. Conterno: Perfect, perfect. John Robson.

Enrique A. Conterno: Perfect, perfect, John Rocha.

Peony Yu: Mike, thank you for the question. We are aware that there is another HIFPHI program that may be disclosing their phase 3 data this year. To address your question, I wanted to remind ourselves that RoxaduceTat is the only HIFPHI program that has already demonstrated positive efficacy and safety data. And so without seeing competitors' data, it's difficult to compare who has better data.

Based on what I have seen on trial clinical trials spot golf odd none of that have P.H.I. phase three program I have to sample size, even near what we have which is over 1500 patients.

Okay, well look for that thank you.

Thank you and our next question comes from Jefferies for just from an DB Leerink. Your line is not open.

Thank you Rick Thank you very much and to appreciate the Ceftriaxone persons.

Peony Yu: And we know that when you conduct a clinical trial, especially a safety outcome trial, one could expect a variety of outcomes. And we have demonstrated a very favorable benefit and risk ratio. Now, however, I could comment on the phase three study design that we have designed a program to demonstrate safety in comparison to placebo and with the hope and confidence of gaining a clean safety label for non-dialysis. And then in incident dialysis, which is highly relevant to treating anemia in dialysis patients, we have demonstrated a 30% reduction in MACE risk and a 34% reduction in MACE plus risk. Based on what I have seen on clinicaltrials.gov, none of the PHI phase three programs have a sample size even near what we have, which is over 1,500 patients.

Recently, Chris could you talk a little bit more about [laughter] belt, the launch of works out as Todd in China, particularly.

How much of a delay do you think that the circumstances there opposing to you and when do you think we much sad to say youre adoption ramp up and particularly when you think you'll be true I'm getting on the hospital formulary list at least the major institutions and then just a little bit more R&D.

Enrique you mentioned.

Sort of investing in both CTGF enhanced biology to broaden the pipeline, but could you give us a sense of what the opportunities you see though because you know many companies in your situation would be saying we need to go to another area. We have pretty good molecules are ready. So what you see is the opportunity from for over invest.

Around the biology of those targets from the pipeline. Thanks.

Good.

Chris a pick us in China. Now then tried to address the R&D question, absolutely Hello, Jeff. So I believe your first question went about the impact of the Corona virus.

Christine L. Chung: Okay, we'll look for that. Thank you. And our next question comes from Jeffrey Forges from SBB LARINC. Your line is now open. Thank you. I thank you very much and appreciate the chance to ask some questions. Quickly, Chris, could you talk a little bit more about the launch of Ruxatastat in China, particularly how much of a delay do you think that the circumstances there are posing to you? And when do you think we might start to see your adoption ramp up? And particularly when you think you'll be through getting onto the hospital formatory list, at least the major institutions. And then just a little bit more on R&D.

So as we all know it's an evolving situation and as we know for the last 30 to 45 days, many things were shut down in China.

Many companies are returning to work and as reported earlier out two factories are back to full normal operations.

We were extremely encouraged by the uptake and listings in the early part of the year immediately after NRG inclusion and before the Corona virus outbreak, we believe as China returns to normal operations the momentum will be weekend.

Enrique A. Conterno: Enrique, you mentioned a sort of inverting.

Christine L. Chung: This is a great launch for CTGF and HIF biology to broaden the pipeline, but could you give us a sense of what the opportunities you see there are, because many companies in your situation would be saying, we need to go to another area. We have pretty good molecules already, so what do you see as the opportunity from further investments around the biology of those targets from the pipeline?

As to when that happened I think your guess is as good as anybody else's. We're generally optimistic that we have the team in place and with the strength of the Astrazenecas sales in key accounts team understands that the product. We think we could we gave them momentum very quickly once that happens.

I believe the second question you had a Jeff was when will the demand uptake be seen and how are we doing in terms of listings in particularly with a major hospitals right. So in terms of the mate.

Christine L. Chung: Chris, take us on China, and I'll then try to address the R&D question.

In terms of demand that comes obviously after only if you listed.

Christine L. Chung: Absolutely. Hello Jeff.

Christine L. Chung: So I believe your first question was about the impact of the coronavirus. So, as we all know, it's an evolving situation, and as we know, for the last 30 to 45 days, many things have been shut down in China. Many companies are returning to work, and as reported earlier, our two factories are back to full normal operation. We were extremely encouraged by the uptake and listings in the early part of the year, immediately after NRD inclusion and before the coronavirus outbreak. We believe as China returns to normal operations, the momentum will be regained. As to when that will happen, I think your guess is as good as anybody else's.

And we believe demand would come naturally after listing.

As to how big of that demand is again it depends on the rate of the listings that we are focusing on in 2020.

In terms of the major hospitals, a as as most innovative companies will tell you. There are approximately 6000 major academic centers in China Roxadustat no different in terms of when we expect to complete listings I think if you look at historic data all the multinationals it takes anywhere from five to six years.

As to list all the hospitals.

However, historically its been indicates that it took a while after launch to gain entry into energy out.

Christine L. Chung: We are generally optimistic that we have the team in place and, with the strength of the AstraZeneca sales and key accounts team and the strength of the product, we think we could regain the momentum very quickly once that happens. I believe the second question you had, Jeff, was when will the demand uptake be seen and how are we doing in terms of listings, in particular with a major hospital? So, in terms of the...

We were fortunate enough that that timeframe was not too long for Roxadustat and we're optimistic that we could finish listings in a timeframe shorter than what was historically the benchmark by multinationals.

Okay, great. Thanks.

Thank you Greece.

Clearly when they are one of the various Jeff that I have been quite impressed when it come into Fibrogen, then discuss being a very positive.

Christine L. Chung: In terms of demand, that comes obviously only if you're listed, and we believe demand would come naturally after listing. As to how big that demand is, again, it depends on the rate of the listings that we are focusing on in 2020. In terms of the major hospitals, as most innovative companies will tell you, there are approximately 6,000 major academic centers in China. Roxadu says no different in terms of when we expect to complete listings. I think if you look at historic data for all the multinationals, it takes anywhere from five to six years to list all the hospitals. However, historically, it's been the case that it took a while after launch to gain entry into NRDL. We were fortunate enough that that time frame was not long for Roxaducet, and we're optimistic that we could finish listing in a time frame shorter than what was historically the benchmark for multinationals.

Surprise.

Uh huh being to see the level of understanding that we have when it comes to both he's biology and CTGF biology.

It is it is it is known the both in particular if is involved in a number of different diseases.

So the opportunities for us to explore and leverage the sees.

He is quite unique.

And then when he comes to CTGF.

Similarly, the application for CTGF are likely in the fibrosis and cancer areas.

Now when I'm when speaking about research I think or the aim here, it's very clear it is to develop.

New drug candidates.

To be able to have a sustainable stream of innovation based on these two scientific platforms, where we.

Enrique A. Conterno: Thanks, Chris.

Enrique A. Conterno: Thank you, Chris. Clearly, one of the areas, Jeff, that I have been quite impressed when coming to FibroGen, and this has been a very positive surprise, has been to see the level of understanding that we have when it comes to both HIF biology and CTGF biology. It is known that both, in particular HIF, are involved in a number of different diseases. So the opportunities for us to explore and leverage this are quite unique. And then when it comes to CTGF, similarly, the application for CTGF is likely in the fibrosis and cancer areas. Now, when speaking about research, I think the aim here is very clear; it is to develop new drug candidates to be able to have a sustainable stream of innovation, based on these two scientific platforms where we are at the leading edge of understanding science.

We are the leading edge of understanding and sign so.

I'm very excited about that than we once again, we'll be providing.

More details on these with the caveats of course that.

HM we might not be able to share everything, though we know for a him. He may not be in fiber just a best interest but is there a we intend to do so provide more feedback on our research on our agenda I into second half of this year.

Okay, great. Thanks very much.

Thank you and our next question comes from and I see from William Blair. Your line is now open.

Great. Thank you for taking my questions and congratulations on all the progress of worldwide.

So I just wanted to ask a clarifying question about kind of that the change in the I.P.S. studies. So so just wanted to really understand what caused it changed from a one study large IPO study to it to attend yeah.

Enrique A. Conterno: So I'm very excited about that, and we, once again, will be providing more details on this, with a caveat, of course, that we might not be able to share everything that we know, for it may not be in FibroGen's best interest, but we intend to do so and provide more feedback on our research and our agenda in the second half of this year. Thank you.

Got it two identical studies is that kind of prompted by the regulators or what I'm, just just wanted to understand that dynamic.

Very good. Thank you for your question I'm Gonna have less address that question I guess the question relates to what caused the change in type in the I'd be a program to go from one study to do studies.

Enrique A. Conterno: Great. Thanks very much. Thank you. And our next question comes from Andai Seath on behalf of William Blair. Your line is now open.

Yeah sure what dishes was not a triggered by any regulatory agencies. This is it triggered by at work until review and to take a look how about to leveled off risk. If it's going was a single study versus going with it two studies that does have most of the time missing the clinical double up into phase three studies that you do too.

Khalil Fenina: Thank you for taking my questions and congratulations on all the progress worldwide. So, I just want to ask a clarifying question about the kind of change in the IPF studies. So, just wanted to really understand what caused the change from a one study, you know, a large IPF study to two, you know, kind of two identical studies. Is that kind of prompted by the regulators or what? I just wanted to understand that dynamic.

That will reduce the level off the statistical significance is required and this is any miss happens is could be happening to reach that highly statistically significant so when we assessed that risk because we thought that they say they say much of that approaches to Medicaid that risk and at the same time did not incur.

Khalil Fenina: Very good. Thank you for your question. I'm going to have Elias address the question. Elias, the question relates to what caused the change in the IPF program to go from one study to two studies.

Khalil Fenina: So this was not triggered by any regulatory agent. This was triggered by our internal review and to take a look at the level of risk if it's going with a single study versus going with the two studies. That is, most of the time, in the clinical development phase, you do three studies, and you do two of them. And that will reduce the level of statistical significance that is required, and this is any mishap that could be happening to reach that highly statistically significant level. So when we assessed that risk, we thought that this was a much better approach to mitigate that risk and, at the same time, did not increase the size of the study tremendously. As you see, it is between the combined two studies versus one study that the increase is manageable. That is the real reason that, for us, we moved from one study to two studies. We heard about this continuously previously about why we are doing this single study, is it riskier or not, and that is only as a step for a risk medication to ensure the success of the program.

He's the size of the study tremendously.

As you see that Tuesday between that up that combine two studies for says when studies that day increases show a manageable.

Is that or real reasons that for us as we move from one study into two studies.

We heard about this is yes, yeah continuously previously about why we are doing single studies, its riskier or not and is only see step for a risk medication to ensure the success of the program.

Got it thank you for that.

Yes.

So that detail and just a question on the potential AD com. So just curious about the company strategy I know you've got you guys are probably.

Preparing for that.

The strategy or the plan of attack for the potential ACA I'm just given the fact that there's a lot is stakeholder.

Houses provider CMS payers that might be watching very carefully at that again potential outcome.

Very good Yeah, let me I'm happy only address the potential outcome for Roxadustat Johnny.

Khalil Fenina: Guy, thank you for that. Yeah, for that detail.

Peony Yu: And just a question on the potential outcome. So just curious about the company's strategy. I know you guys are probably, you know, preparing for that. Just the strategy or the plan of attack for the potential outcome, just given the fact that there are a lot of stakeholders, you know, dialysis providers, CMS payers that might be watching very carefully at that, again, potential outcome.

Yeah, so you're not interaction with the F.D.A. There is no indication for an economic at this time, we will be a we are preparing and we'll be well prepare alright. If that's one they had three possible time points that F.D.A. may notified a sponsor.

<unk> com eat up before the end da submission.

Or at the time off a unit showed a six first 60 days off initial a checklist before by the time off that they 74 letter where they inform the sponsor a bow and D.A. acceptance.

Peony Yu: Very good. Yeah, let me have Peony address the potential outcome for Roxy Dustin. Peony?

Peony Yu: So in our interaction with the FDA, there is no indication of an ECOM at this time. We will be, we are preparing, and will be well prepared if there is one. There are three possible time points that FDA may notify a sponsor about ECOM, either before the NDA submission or at the time of the initial six first 60 days of the initial checklist before or by the time of the day 74 letter where they inform the sponsor about NDA acceptance or any kind during the FDA's review. And the final decision on whether to accept ECOM or not really lies within the FDA.

Or anytime during the odd ft Ace we view.

And the final decision not at come on not really lies within the F.D.

And maybe just to add to beyond its beauties responds clearly we are conducting a very thorough preparation regardless oh. The do we have not been given these indication of how can we have to prepare regardless.

On a in order to do though we're following or what it was just because he's the best practices for outcome preparation of course, we think about all stakeholders, but in particular been able to address the questions don't make comment the outcome. So doesn't work is in brokers.

Enrique A. Conterno: And maybe just to add to Peony's response, clearly, we are conducting a very thorough preparation regardless that we have not been given this indication of outcome. We have to prepare regardless, and in order to do that, we're following what is considered best practice for outcome preparation, and of course, we think about all stakeholders but in particular, being able to address the questions that may come at the outcome. So that work is in progress.

Okay.

Great. Thank you for answering unlikely.

Thank you and our next question comes from Joel breed from Citi. Your line is now open.

Hi, Thanks for the questions. The first one is on the I.P.F. phase three program, especially from one trial that too I'm could you talk about how the powering of the phase three program as affected from that switch and do you anticipate that both phase three trials, we need to be successful or cut the previous phase two trial curious.

And why is it as well.

Very good he asked the question is related to wipe yes.

Enrique A. Conterno: [inaudible] Great, thank you for answering all my questions. Thank you. And our next question comes from Joel Breede from Citi. Your line is now open.

How is the powering effective on whether both phase three trials need to be successful if you could address them.

Khalil Fenina: Hi, thanks for the questions. The first one is on the IPF Phase 3 program, the switch from one trial to two. Could you talk about how the funding of the Phase 3 program is affected by that switch, and do you anticipate that both Phase 3 trials will need to be successful, or could the previous Phase 2 trial carry some weight as well?

Yes and Ah.

It should we powered this study to or.

Planned for success.

That is our first same show we maintain a this study to be highly powered.

Similarly to the first study that she's yeah, we plan, which is we're not changing anything send us idea that then the size of.

Khalil Fenina: Very good. Elias, the question is related to IPF. How is the powering effective and whether both phases of 3000 need to be successful? If you could address that.

A patient and enrolled in Nash study, so we wouldn't maintained or a very high level of following of this study and now we had base. It on our analysis of all the data that we currently have it from our phase two in phase two of these studies and we're taking in consideration is just a available.

Khalil Fenina: Yes. And... And so we powered this study to, um, um, uh, plan for success. So that is our first aim. So we maintain the study to be highly powered, similarly to the first study that we planned, which was we're not changing anything in that study other than the size of the patient and role in that study. So we will maintain a very high level of powering of the study, and we'll base it on our analysis of all the data that we currently have from our phase two A and phase two B studies. And we're taking into consideration the available data in IPF from these other studies that led to the approval of the other two products, Nintendo and Perfinidone. And so we combined all this data. We combined all this data, and that was the basis for powering our study.

And IPO, Jeff from these other studied that led to the approval of the other two products intended and pirfenidone.

Sure. We has combined all these today, though.

We combined the oldest data and.

That was the basis for fall or powering up always study.

Right so.

So I hope this is answered your question.

Yeah, Yeah, Yeah, yeah. Thank you Leo maybe I can also complement the Lisas question, Joe clearly a the change the we're making just increase the likelihood of success.

For.

And yes, we are expecting both phase three trials need to be successful we need both drugs to be successful for us to have a successful program.

Khalil Fenina: If you like,

Khalil Fenina: So I hope this has answered your question.

Understood and then if I could ask one other question, Brian Roxadustat <unk> tell us about the launch preparations that are underway, particularly anything unique for you know, but the type of drug that is there such as to death or payment agreements or agreements with dialysis providers.

Enrique A. Conterno: Thank you, Elias. Maybe I can also compliment Elias' question. Joe, clearly the change that we're making is to increase the likelihood of success, for And yes, we are expecting both phase three trials to be successful. We need both trials to be successful for us to have a successful program.

Yeah.

Enrique A. Conterno: Okay. And I could ask one other question about RoxaDustat. Could you tell us about the launch preparations that are underway, particularly anything unique for the type of drug that it is, such as Tadepa, payment agreements, or agreements with dialysis providers?

Let me try to address that.

A question clearly a we are working on preparations for launch in the U.S. really we have a great partner in a Astra Seneca, but he's a.

Leading that effort and we will complement Astra zeneca when it comes to a medical affairs and our science.

To ensure that we found to have a highly successful launch.

Enrique A. Conterno: Yeah, let me try to address that question.

Enrique A. Conterno: Clearly, we are working on preparations for launch in the U.S. We really have a great partner in AstraZeneca that is leading that effort, and we will complement AstraZeneca when it comes to medical affairs and our science to ensure that we can have a highly successful launch. Clearly, there are many aspects that one has to prepare for when it comes to a U.S. launch, and you are making comments about T

Clearly there are many aspects the one has to prepare for when it comes to a U.S. launch.

You are making comments about dapa as you know CMS every year updates what is called the end stage renal disease.

Prospective payment system or commonly known as the bundle a these rules us I continue to evolve and now has the policy that provides for these I don't payment so dapa.

Enrique A. Conterno: As you know, CMS every year updates what is called the end-stage renal disease Prospective Payment System, or commonly known as DABANDO. This rule has continued to evolve and now has a policy that provides for this add-on payment, TADAPA, which basically provides a payment for drugs that otherwise would be included in DABANDO. Making sure that we're fully prepared, and it is always difficult to say how the rules will continue to evolve, but based on our discussion with the CMS, we believe that we're in a very good position. We also are looking, of course, at the non-dialysis dependent segment. And as you know, we have, of course, patients that are covered through Medicare, in particular Part D, and also patients on Medicaid, and also patients on commercial insurance. So we need to make sure that, at the end of the day, this product is going to be reimbursed broadly. And we are; AstraZeneca is leading the charge to ensure that it's going to be.

Which basically provides a they pay but for drugs that otherwise would be included in the bond. The we clearly are looking when it comes to the dialysis segment.

Making sure that were fully prepared and I'm being a it is always difficult to an to say how the rule will continue to evolve, but I based on their discussion with the CMS. We believe the we're in a very good.

Position.

We also are looking to Oh of course nondollar, the non dialysis dependent segment and as you know we have a of course patient that are covered through Medicare in particular part D and also patience on Medicaid and and also patients on commercial insurance so.

We are we need to make sure that or the other day. This product is going to be reimbursed or broadly and we are astrazenecas, leading the charge to ensure that he's going to be the case.

Very good thank you.

Thank you and our next question comes from Paul Choice and Goldman Sachs. Your line is now open.

Enrique A. Conterno: Very good, thank you.

Thank you ran a good afternoon, everyone I'm I wanted to ask with regard to the to the phase three four roxa in Mds.

Paul Choi: Thank you. And our next question comes from Paul Choi from Goldman Sachs.

Peony Yu: Your line is now open. Thank you, and good afternoon everyone. I want to ask with regard to the phase 3 for Roxa in MDS. There is a company, you know, facing a PDUFA here about to commercialize a drug for anemia of MDS potentially in the not too distant future. So, I was just wondering, you know, as you think about the phase 3 trial design, can you maybe just clarify for us, you know, is there an interim built in where you do, if you do see an adequate separation with regard to transfusion independence rates at an interim, is that something you could stop the early trial, the trial early on and then add a follow-up? Thank you.

There is a company <unk> you know about facing up here for hearing about to commercialize a drug for anemia of MBS into potentially in the not too distant future. So just wondering you know as you think about the phase three trial design can you maybe just clarify for us. So is there an interim built in where you do if you do see an adequate separation with regard to transfusion independence right.

At at the end around was that something you could stop the early trial. The trial early on and then I had a follow up thank you.

The Oneq could you address a question on a Mds competition on whether we have an interim.

Yes, I'm happy to uphold thanks for the question Paul So we have for you. We have had two parts to our phase three study in patients with M.D.S. anemia, or we have filed this close the first part which is the open label eat in component on top.

Peony Yu: Peony, could you address the question on the MDS competition and whether we have an interim solution?

Peony Yu: Three studies in patients with MDS anemia. We have disclosed the first part, which is the open-label lead-in component, and presented that positive result at ASH in 2019. The rest of the study is double-blind placebo control, and at this time, we do not have a plan for interim analysis. Now, in terms of comment on the competition, I believe that you must be referring to Luz Petersen, Paul, right?

And that that positive result at the Ash a in 2019, that's a that's something that study is a double blind placebo control.

At this time, we do not have a plan for an interim analysis now in terms of common on the competition, Doug Anmuth I believe that you must be referring to lose paid to us that Paul right. Yes. That's currently yeah. It is a.

Peony Yu: Yes, that's correct.

Peony Yu: Yeah, it is a drug with a different mechanism of action, and that program is targeting only patients, MDS patients, with ring sideroblasts, RS positive, whereas our program does not have that restriction, and also, our agent is a HIF-PHI, and it is orally available, whereas the other drug is parenterally administered. So those are some of the very obvious differences, and this is an area of great medical need, and we feel very comfortable wanting to pursue this program and confident in the successful unit.

Trump what that different mechanism of action and ER and that program is targeting only patients a mds a patients was ranked possibly a a with a ring sideroblasts I asked positive where as such our program odd does not have that Mr.

Action.

And and also our to our intention is to have P.H.I. editas all readily available.

And while at the other truck is that parental leave a minister. So bear there are those are some other very oh, yes differences and Todd. This is an area also great unmet medical need then and we feel very comfortable wanting to and.

A couple pursue this program and confident in a successful in it.

Peony Yu: And then just as a follow-up for PAMREV-LUMAB, specifically with regard to DMD, I know you've disclosed which aspects of the program are advancing, but are you thinking maybe about a potential broader development program here in any other subpopulations? Any color there you could offer would be great. Thank you.

Great and then just has as a follow up for Pamrevlumab, specifically with regard to DMT I know, the you've disclosed, which which you know aspects of the program are advancing but are we thinking maybe about a potential a broader development program here in any other other sub populations any a any color there you could offer.

Khalil Fenina: So, Elias, I think the question is here related to panbrelumab and DMD. And if you could provide maybe some color and a broader program, are we looking at other subpopulations as well?

It would be great. Thank you.

So actually I think the question is a here related to umbrella my if in the M.D. and a if you could provide maybe some color on a brother program are we looking at other sub populations as well.

Khalil Fenina: So currently, as you know, our study is in the non-ambulatory population, and we're concentrating this discussion, Paul, on the non-ambulatory population. But at the same time, during our discussion with the agencies, we are talking about the ambulatory population and looking to see how the program will look if we add this population to our study. We are, as we said, in progressing the discussion with the agencies, including the AMA, not only the FDA, and we can give more guidance on this following earnings calls. But at this time, the first study that we are concentrating on is the non-ambulatory study.

Yeah. So currently as you know our study isn't a non ambulatory and we're concentrating this discussion fall about the non ambulatory at the same time during our discussion.

With the agencies, we are talking about today ambulatory population and now looking at Ti Ah Ah two she that she said how the program one looks like as if we add the share this population to Oh, sorry, we already and we said didnt progressively that discussion with the agencies, including day EM.

And I told you that FDA anyway, you can give more guidance on this shouldn't now following go earning calls but at this time. They said the first is studies that we are concentrating on is the non ambulatory study.

Khalil Fenina: Thank you. And our next question comes from Daifei Yang from Miho Securities. Your line is now open.

Very good.

Thank you and our next question comes from Die say Yang from Me Hills Securities. Your line is now open.

Daifei Yang: Hi, good afternoon. Thanks for taking my questions. There are just a couple.

Hi.

Good afternoon, Thanks for taking my questions.

Oh I'm still with regards to the outcome can at come Dean <unk> in the case, if one was to take place how much a advance notice you is back to that [laughter].

Daifei Yang: So with regard to the outcome meeting, in the case if one was to take place.

Daifei Yang: How much advance notice do you expect to get?

Yes.

Daifei Yang: We will see you next time.

The only do you want to drive a addressed a question on Jack on what he's got bus noticed Difei I believe after you usually give at least 45 business days up the for the actual meeting.

Peony Yu: Peony, do you want to address the question of the outcome; what is the advance notice?

Okay. Thank you.

And the next mining is that getting closer to commercialization, how you're so what's your current thinking with regards to for the TB setting dialysis setting whether that drug will be in the bundle or not the phone though.

Peony Yu: DFAY, I believe FDA usually gives at least 45 business days before the actual meeting.

Daifei Yang: Okay, thank you. And the next one is that as you're getting closer to commercialization, how is, what's your current thinking?

Yes, I. It is it is difficult I'm going to try to address that question.

Clearly it is difficult to predict whether we're going to being the bundled or not but we are preparing for both scenarios.

Daifei Yang: The end.

Daifei Yang: is deciding whether the drug will be in the bundle or not in the bundle.

Enrique A. Conterno: Yes, it is difficult. I'm going to try to address that question. Clearly, it is difficult to predict whether we're going to be in the bundle or not, but we are preparing for both scenarios by having discussions with Thank you very much.

But having discussions with.

CMS, if we work to being the bonds on US. We have described we believe the rock. So we would be eligible for dapa on the drug the out on payment, which would be <unk> type scenario.

Daifei Yang: Okay, okay, thank you.

Okay. Okay. Thank you.

Yes, a in Q.

Enrique A. Conterno: Thank you. Now, I would like to turn the call back over to Enrique Conterno for his closing remarks.

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

Enrique Conterno for closing remarks.

Operator: Thank you very much. We appreciate everyone's participation in today's investor call and your interest in FibroGen. Please follow up with our investor relations team if you have any questions we have not addressed on the call, and enjoy the rest of your day. Thank you very much.

Yeah.

Right.

Thank you very much a we appreciate everyone's participation in today's investor call and your interest in Fibrogen.

Please follow up with our Investor Relations theme. If you have any question we have not addressed in the call on enjoy the rest of your day. Thank you very much.

Operator: Thank you, and ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect. (inaudible) ENTERTAINMENT WEEKLY

Thank you and ladies and gentlemen, this concludes todays conference call. Thank you for participation you may now disconnect.

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