Q2 2017 FibroGen Inc Earnings Call

Q2 2017 FibroGen Inc Earnings Call

SAN FRANCISCO Aug 7, 2017

(Thomson StreetEvents) Preliminary Transcript of FibroGen Inc earnings conference call or presentation Monday, August 7, 2017 at 9:00:00pm GMT

TEXT version of Transcript

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Corporate Participants

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FibroGen, Inc. VP of Clinical Development, Drug Safety &

FibroGen, Inc. Chief Medical Officer

FibroGen, Inc. VP of IR & Corporate Communications

FibroGen, Inc. VP of Finance & CFO

FibroGen, Inc. VP of Fibrosis Therapeutics

FibroGen, Inc. Founder, Chairman & CEO

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Conference Call Participants

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Leerink Partners LLC, Research Division MD, Biotechnology, Director

of Therapeutics Research and Senior Biotechnology Analyst

Citigroup Inc, Research Division VP and Analyst

Jefferies LLC, Research Division Equity Analyst

Goldman Sachs Group Inc., Research Division MD

Stifel, Nicolaus & Company, Incorporated, Research Division Analyst

William Blair & Company L.L.C., Research Division Senior Research

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Welcome to the FibroGen, Inc. Second Quarter 2017 Financial Results Conference Call. My name is Ally, and I will be your operator today. (Operator

Please note that this conference is being recorded. A webcast of this call will be available on the company website 2 weeks from

today s date. For opening remarks and introduction, I ll now turn the call over to Karen Bergman, Vice President, Investor Relations and Corporate Communications. Please go ahead.

Karen L. Bergman, FibroGen, Inc. VP of IR & Corporate Communications [2]

Thank you, Ally, and again this is Karen Bergman. Good afternoon, everyone, and welcome to FibroGen s financial results and corporate update call

for the second quarter of 2017. The call will be led

by Tom Neff, our Chief Executive Officer. Tom will kick off the call today with our top line Phase II results for pamrevlumab in idiopathic pulmonary fibrosis and later will discuss progress and

milestones for our product development programs.

We are joined today by Dr. Peony Yu, Chief Medical Officer, and she will discuss top line efficacy

results from our Phase II placebo-controlled clinical study assessing the efficacy of pamrevlumab in the treatment of IPF and the two comparator controlled sub-studies using pamrevlumab in combination with

approved IPF therapies as well as our anemia program in China and recent clinical results related to the down regulation of hepcidin.

Kouchakji, Vice President, Clinical Development, Drug Safety and Pharmacovigilance and the clinical team leader for the pamrevlumab program, will discuss the safety results from our IPF Phase II study.

Dr. Seth Porter, Vice President and project team leader for fibrosis therapeutics, will provide pamrevlumab program updates.

Mr. Pat Cotroneo, Chief Financial Officer, will review financial performance in the second quarter.

Also joining us for the Q&A portion of the call is Dr. Eduard Gorina, Executive Director of Clinical Development.

On this call, we expect to 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; research and development activities; 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 Form 10-K for the fiscal year ended December 31, 2016, and quarterly reports, including our Form

10-Q for the period ended March 31, 2017, filed with the 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 statement, whether as a result of new information, future developments or otherwise.

The format for today s call will

include remarks from FibroGen s management team, and then we ll open the lines to take your questions. A webcast of this conference call will be available for replay again on the Investors page on FibroGen s website,

And now, it is my pleasure to turn the call over to our CEO, Tom Neff.

Thomas B. Neff, FibroGen, Inc. Founder, Chairman & CEO [3]

Thank you, Karen. Good afternoon, everyone. Thank you for joining us today. This is an exciting time for FibroGen, and we look forward to sharing with

you recent advances across our pipeline and in multiple therapeutic indications.

First, with pamrevlumab, we are pleased to report to you topline results

from our randomized placebo-controlled double-blind Phase II study of pamrevlumab and IPF, and our combination sub-studies with the approved drugs. We view these data as an important milestone for the company

and for the program, and we believe the results of this study enable us to move into Phase III with IPF.

Study 067 includes a main study and 2 sub-studies: first the 48-week placebo-controlled study; second, two combination 24-week safety

sub-studies. In the double-blind placebo-controlled study, 103 patients were randomized in one-to-one ratio to receive either

pamrevlumab or placebo for 48 weeks.

In terms of FVC percent predicted, the primary endpoint of the study, the decline in FVC percent predicted from

baseline to week 48 was 2.85 in the pamrevlumab arm, as compared to a decline of 7.17 in the placebo arm, a statistically significant result. In terms of FVC, as measured in volume, the pamrevlumab-treated patients had an average decrease of FVC of

129 ml at week 48 as compared to an average decrease of 308 ml in the patients receiving placebo, a difference that was also statistically significant.

For clarity, I should point out that we chose to use of the random coefficient linear regression model similar to the methodology employed by Boehringer

Ingelheim in their Phase III U.S. study in nintedanib. We chose this method because the published FDA clinical and statistical review or comments after the Phase III made it clear that this approach is acceptable and not controversial.

Turning to safety. Pamrevlumab continued to be well tolerated as monotherapy and IPF patients consistent with previous clinical studies and was also well

tolerated when administered in combination

with either pirfenidone or nintedanib. We did not see any synergistic or unexpected safety result when pamrevlumab was combined with either of the approved drugs. Dr. Kouchakji will further

describe later on in this call. We will present additional data regarding these studies from by Dr. Yu and Dr. Kouchakji immediately after my remarks.

We continue to believe IPF will be a significant value generator for pamrevlumab due to severe unmet medical need and limited life expectancy at the time of

diagnosis. Pamrevlumab may represent a valuable option to treat IPF patients as our results suggest improvements in both standard measurements in lung function, improved safety and quantitative measurement of fibrosis.

We will also be showing further results from the 067 study in an oral presentation at the European Respiratory Society International Congress in Milan, Italy

next month. We ll also be presenting interesting preclinical data comparing pamrevlumab to the approved therapies in the highly predictive radiation-induced fibrosis model. It was in this model that we demonstrated the ability of pamrevlumab to

reverse lung remodeling and to improve pulmonary function.

The results in this model demonstrate superior performance of pamrevlumab for inhibition of

fibrosis and reversal of gene expression associated with fibrosis.

With respect to pamrevlumab development for treatment of unresectable locally advanced

pancreatic cancer, the U.S. Food and Drug Administration recently granted orphan drug designation status to pamrevlumab for the treatment of pancreatic cancer. We had previously received orphan drug designation for pamrevlumab for the treatment of

IPF. In our ongoing Phase II study, we continue to see favorable differences in resectability and trends in the overall survival between patients in the pamrevlumab-treated and the control arm. We expect to report results at the end of this year or

early next year at a scientific conference.

We continue to enroll patients in our Phase II open-label study of pamrevlumab in non-ambulatory Duchenne muscular dystrophy, or DMD patients. Pamrevlumab has the potential to be a disease-modifying therapy for DMD by countering the activity of elevated CTGF and the harmful effects of fibrosis in

Following remarks on our IPF data reported today, Dr. Peony Yu will also provide a status report on our roxadustat program and Pat

Cotroneo will summarize our second quarter results. Then I will wrap up our remarks today with an update on milestones followed by your questions.

that said, I would now like to turn the call over to Dr. Peony Yu to discuss today s IPF results. Peony?

K. Peony Yu, FibroGen, Inc. Chief Medical Officer [4]

The 067 main study was a Phase II,

randomized double-blind placebo-controlled clinical trial to evaluate the safety and efficacy of FG-3019 in 103 patients with idiopathic pulmonary fibrosis, with most of the patients in the U.S.

IPF is a chronic progressive fatal disease characterized by fibrosis in the lungs resulting in loss of lung function and exercise capacity. Despite the

availability of new drugs for IPF within the last few years, there remains a need for better and safer treatment options.

After a screening period of up

to 6 weeks, study subjects received 30 milligrams per kilogram of pamrevlumab or placebo intravenously every 3 weeks for 48 weeks. Lung function assessments were conducted at baseline and at weeks 12, 24, 36 and 48.

The IPF diagnostic criteria utilized for patient selection was based on the current international guidelines.

The key function assessment of IPF progression is pulmonary function. The primary efficacy of assessment is forced vital capacity or FVC. The FVC change from

baseline to 48 weeks was analyzed both in FVC (measured in ml) and in FVCpercent predicted, adjusted for age, race, sex and height. This latter parameter, FVC percent predicted, was designated as the primary endpoint.

In the Intent to Treat population, pamrevlumab had a statistically significant lower rate of decline than placebo in FVC volume and FVC percent predicted when

analyzed using the predefined method of linear slope model, also known as the random coefficient linear regression model. The absolute decline in FVC percent predicted from baseline to week 48 was 2.85% in the pamrevlumab arm as compared to a

decline of 7.17% in placebo, an absolute difference of 4.33%. Thus, the relative decline was 60% less than placebo, with a P value of 0.0331.

The mean decline in FVC volume from baseline to week 48 in pamrevlumab-treated patients of 129 milliliters was

statistically less than placebo of 308 ml, with a difference of 178 ml, or a relative decline of 58% lower than the placebo arm, with a significant p-value of 0.0249.

The findings in this placebo-controlled study are consistent with and additive to earlier completed open- label Phase II study in IPF, study 049.

Dr. Kouchakji will now present the safety results.

Elias Kouchakji, FibroGen, Inc. VP of Clinical Development, Drug Safety & Pharmacovigilance [5]

Thank you, Peony. I would now like to share with you safety result of our studies with placebo-controlled 103 patients in