On March 1, 2021 FibroGen, Inc. (NASDAQ: FGEN) reported financial results for the fourth quarter and full year 2020 and provided an update on the company’s recent developments (Press release, FibroGen, MAR 1, 2021, View Source [SID1234575842]).

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"While disappointed with the news today, FibroGen and AstraZeneca remain confident in the efficacy and safety profile of roxadustat based on positive results from a global Phase 3 program encompassing more than 8,000 patients," said Enrique Conterno, Chief Executive Officer, FibroGen. "With strong roxadustat commercial results in China, we continue to drive forward in our three main areas of focus: ensuring the regulatory and commercial success of roxadustat; accelerating the development of pamrevlumab in the three high-value indications of locally advanced unresectable pancreatic cancer (LAPC), Duchenne muscular dystrophy (DMD), and idiopathic pulmonary fibrosis (IPF); and building our research capabilities in both hypoxia-inducible factor (HIF) and connective tissue growth factor (CTGF) biology while adding to our clinical development pipeline."

Key Events in 2020 and Other Developments

Roxadustat

Regulatory:
The Cardiovascular and Renal Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) will hold an advisory committee (AdCom) meeting to review the new drug application (NDA) for roxadustat in the U.S. The companies have not received a confirmed AdCom meeting date from the FDA.
In November 2020, Japan’s Ministry of Health, Labour and Welfare (MHLW) approved EVRENZO (roxadustat) for the treatment of anemia of CKD in adult patients not on dialysis.
The Marketing Authorization Application (MAA) for roxadustat for the treatment of anemia in adult patients with CKD was accepted for regulatory review by the European Medicines Agency (EMA) in May 2020, with an expected decision by mid-2021.
Clinical:
Enrollment was completed in the WHITNEY US Phase 2 roxadustat clinical trial in chemotherapy-induced anemia (CIA) in 4Q 2020.
Enrollment continued in the MATTERHORN Phase 3 roxadustat clinical trial in anemia associated with myelodysplastic syndromes (MDS).
Enrollment was completed in the ASPEN and DENALI Phase 3b roxadustat clinical trials in dialysis patients with anemia of CKD.
Publications / Presentations:
Roxadustat data was presented at the following scientific meetings in 2020:
The National Kidney Foundation Spring Clinical Meeting
The 57th European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) Virtual Congress
The American Society of Nephrology (ASN) Kidney Week 2020 Reimagined
The 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition
Roxadustat Phase 3 manuscripts on the treatment of anemia of CKD were published in peer-reviewed medical journals:
Pooled Analysis of Roxadustat for Anemia in Patients with Kidney Failure Incident to Dialysis Kidney International Reports
Roxadustat for Chronic Kidney Disease-related Anemia in Non-dialysis Patients Kidney International Reports
Roxadustat for Treating Anemia in Patients with CKD Not on Dialysis: Results from a Randomized Phase 3 Study Journal of the American Society of Nephrology
Roxadustat for the Treatment of Anemia in Chronic Kidney Disease (CKD) Patients Not on Dialysis: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study (ALPS) Nephrology Dialysis Transplantation
Roxadustat for anemia in patients with end-stage renal disease incident to dialysis Nephrology Dialysis Transplantation
Pamrevlumab

Enrollment continued in the LAPIS Phase 3 clinical trial of pamrevlumab in patients with locally advanced unresectable pancreatic cancer (LAPC).
Enrollment continued in the LELANTOS Phase 3 clinical trial of pamrevlumab in non-ambulatory patients with Duchenne muscular dystrophy (DMD).
Enrollment continued in the ZEPHYRUS Phase 3 clinical trial of pamrevlumab in patients with idiopathic pulmonary fibrosis (IPF).
In December, we initiated a second Phase 3 clinical trial of pamrevlumab, ZEPHYRUS-2, in patients with idiopathic pulmonary fibrosis (IPF).
Upcoming Data Catalysts

Data from the Phase 2 WHITNEY study of roxadustat in chemotherapy-induced anemia (CIA) expected 2H 2021.
Data from the Phase 3 MATTERHORN study of roxadustat in anemia of myelodysplastic syndromes (MDS) expected 1H 2022.
Resection data from the Phase 3 LAPIS study of pamrevlumab in locally advanced pancreatic cancer (LAPC) expected 2H 2022.
Data from the Phase 3 LELANTOS study of pamrevlumab in Duchenne muscular dystrophy (DMD) expected 2H 2022.
2020 Key Executive Additions

Percy Carter, Ph.D., was appointed to the newly created position of Chief Scientific Officer.
Mark Eisner, M.D., M.P.H., was appointed as Chief Medical Officer.
Thane Wettig was appointed to the newly created position of Chief Commercial Officer.
Financial

Total revenue for the fourth quarter of 2020 was $65.0 million, as compared to $8.0 million for the fourth quarter of 2019. The current quarter revenue consists of net product revenues of $29.2 million for roxadustat sales in China, $21.5 million in development revenue, and $14.3 million in license revenue related to NDD approval in Japan. Total net roxadustat sales in China for 2020 were $72.5 million.
Net loss for the fourth quarter of 2020 was $58.6 million, or $0.64 net loss per basic and diluted share, compared to a net loss of $98.1 million, or $1.12 net loss per basic and diluted share one year ago.
Net loss for the year was $189.3 million, or $2.11 net loss per basic and diluted share, compared to a net loss of $77.0 million, or $0.89 net loss per basic and diluted share one year ago.
At December 31, 2020, FibroGen had $732.1 million in cash, restricted time deposits, cash equivalents, investments, and receivables.
Based on our latest forecast, we estimate our 2021 ending cash to be in the range of $660 to $670 million.
The China Agreement with AstraZeneca was amended in July 2020 to maximize the economic value of the roxadustat franchise for both parties with more predictable economics and profitability for FibroGen.
Conference Call and Webcast Details
FibroGen will host a conference call and webcast today, Monday, March 1, 2021, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) to discuss financial results and provide a business update. A live audio webcast of the call may be accessed in the investor section of the company’s website, www.fibrogen.com. To participate in the conference call by telephone, please dial 1 (877) 658-9081 (U.S. and Canada) or 1 (602) 563-8732 (international), reference the FibroGen fourth quarter and full year 2020 financial results conference call, and use confirmation number 3055327. A replay of the webcast will be available shortly after the call for a period of four weeks. To access the replay, please dial 1 (855) 859-2056 (domestic) or 1 (404) 537-3406 (international), and use passcode 3055327.

About Roxadustat
Roxadustat, an oral medicine, is the first in a new class of medicines, HIF-PH inhibitors that promote erythropoiesis, or red blood cell production, through increased endogenous production of erythropoietin; improved iron absorption and mobilization; and downregulation of hepcidin. Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and for chemotherapy-induced anemia (CIA).

Roxadustat is approved in China, Japan, and Chile for the treatment of anemia of CKD in adult patients on dialysis (DD) and not on dialysis (NDD). In Europe, the Marketing Authorization Application for roxadustat for the treatment of anemia in with chronic kidney disease (CKD) in NDD and DD patients was filed by Astellas Pharma Inc. (Astellas) and accepted by the European Medicines Agency for review in May 2020. Several other licensing applications for roxadustat have been submitted by Astellas and AstraZeneca to regulatory authorities across the globe, and are currently in review.

Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in territories including Japan, Europe, Turkey, Russia and the Commonwealth of Independent States, the Middle East, and South Africa. FibroGen and AstraZeneca are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in the U.S., China, other markets in the Americas, in Australia/New Zealand, and Southeast Asia.

About Pamrevlumab
Pamrevlumab is a first-in-class antibody developed by FibroGen that inhibits the activity of connective tissue growth factor (CTGF), an important biological mediator in fibrotic and proliferative disorders. Pamrevlumab is in Phase 3 clinical development for the treatment of locally advanced unresectable pancreatic cancer (LAPC), Duchenne muscular dystrophy (DMD), and idiopathic pulmonary fibrosis (IPF). For information about pamrevlumab studies currently recruiting patients, please visit www.clinicaltrials.gov.