On May 7, 2020 FibroGen, Inc. (NASDAQ: FGEN) reported financial results for the first quarter of 2020 and provided an update on the company’s recent developments (Press release, FibroGen, MAY 7, 2020, View Source [SID1234557273]).
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"During this difficult time, we continue to be inspired by our unique opportunity to leverage world-class science to benefit patients," said Enrique Conterno, Chief Executive Officer, FibroGen. "The COVID-19 pandemic has presented a number of unprecedented challenges, including in the conduct and enrollment of our clinical trials. Nevertheless, I want to reassure patients, healthcare providers, and stakeholders of our continued commitment to bring to patients our potential first-in-class medicines for the treatment of chronic and life-threatening conditions. Our strong financial position gives us sufficient runway to navigate this storm."
"We remain focused on ensuring the regulatory and commercial success of roxadustat, a potentially transformational oral medicine in anemia therapy, first demonstrated in patients with chronic kidney disease. With pamrevlumab, our monoclonal antibody targeting connective tissue growth factor (CTGF), we are implementing a comprehensive plan to accelerate development across the three indications of idiopathic pulmonary fibrosis (IPF), locally advanced unresectable pancreatic cancer (LAPC), and Duchenne muscular dystrophy (DMD) once the situation with COVID-19 improves. Finally, we continue to advance the innovation of our hypoxia-inducible factor (HIF) and CTGF platforms."
Key Events in Recent Months and Other Developments
Roxadustat
U.S. NDA for roxadustat for the treatment of anemia of chronic kidney disease (CKD), in non-dialysis-dependent and dialysis-dependent patients, is under review with a Prescription Drug User Fee Act (PDUFA) date of December 20, 2020.
Japan sNDA for roxadustat for the treatment of anemia of chronic kidney disease (CKD) in non-dialysis-dependent patients is under review.
Presented new analyses from our Phase 3 roxadustat trials at the annual National Kidney Foundation Spring Clinical meeting which demonstrated:
Roxadustat corrected and maintained hemoglobin in non-dialysis dependent patients with anemia using similar doses regardless of iron status at baseline.
Roxadustat reduced the risk of red blood cell transfusions and IV iron rescue compared to placebo in non-dialysis CKD patients, regardless of iron status at baseline.
Roxadustat reduced the risk of red blood cell transfusion during anemia treatment in dialysis dependent CKD patients vs. epoetin alfa.
Pamrevlumab
To minimize the risk of exposure to COVID-19 in the vulnerable patient population with compromised lung function from idiopathic pulmonary fibrosis (IPF), paused near-term enrollment of ZEPHYRUS Phase 3 clinical trial of pamrevlumab in patients with IPF.
Continue to enroll the LAPIS Phase 3 clinical trial of pamrevlumab in patients with locally advanced unresectable pancreatic cancer (LAPC).
Upcoming Events
In Europe, the Marketing Authorization Application filing for roxadustat for the treatment of anemia in both dialysis- and non-dialysis-dependent patients with CKD is expected in the second quarter of 2020.
Plan to initiate ZEPHYRUS 2, a second IPF Phase 3 clinical trial similar in size and design to ZEPHYRUS, as COVID-19 conditions improve.
Plan to initiate LELANTOS, a Phase 3 global clinical trial of pamrevlumab in DMD in the second half 2020. This trial will enroll approximately 90 patients randomized 1:1 to placebo and have a treatment period of 52 weeks.
Corporate and Financial
Total revenue for the first quarter of 2020 was $24.4 million, as compared to $23.9 million for the first quarter of 2019. The current quarter revenue consisted of $19.4 million in development revenue, and $5.0 million in net roxadustat sales in China.
Net loss for the first quarter of 2020 was $78.3 million, or $0.89 net loss per basic and diluted share, compared to a net income of $45.4 million, or $0.53 net loss per basic and diluted share one year ago.
At March 31, FibroGen had $598.4 million in cash, cash equivalents, restricted time deposits, investments, and receivables.
Based on our latest forecast, we reiterate our year end 2020 estimate to be in the range of $720 million to $730 million in cash, cash equivalents, restricted time deposits, investments, and receivables.
Conference Call and Webcast Details
FibroGen will host a conference call and webcast today, Thursday, May 7, 2020, 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 first quarter 2020 financial results conference call, and use passcode 9946439. A replay of the webcast will be available shortly after the call for a period of two weeks. To access the replay, please dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and use passcode 9946439.
About Roxadustat
Roxadustat is a first-in-class, orally administered small molecule HIF-PH inhibitor that promotes erythropoiesis through increasing endogenous production of erythropoietin, and improved iron absorption, transport and mobilization. Roxadustat is approved in China for the treatment of anemia in CKD patients on dialysis and patients not on dialysis, and is approved in Japan for the treatment of anemia in CKD patients on dialysis, and a supplemental NDA for the treatment of anemia in CKD patients not on dialysis is under regulatory review. The roxadustat NDA for the treatment of anemia in CKD is under review by the U.S. FDA with a Prescription Drug User Fee Act date of December 20, 2020. Our partner Astellas expects the Marketing Authorization Application filing for roxadustat for the treatment of anemia in CKD in the second quarter of 2020. Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and for chemotherapy-induced anemia.
Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the treatment of anemia in territories including Japan and Europe. AstraZeneca and FibroGen are collaborating on the development and commercialization of roxadustat for the treatment of anemia in the U.S., China, and other markets.
About Pamrevlumab
Pamrevlumab is a first-in-class antibody developed by FibroGen that inhibits the activity of connective tissue growth factor (CTGF), a common factor in fibrotic and proliferative disorders. Pamrevlumab is in Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF) and locally advanced unresectable pancreatic cancer (LAPC), and in Phase 2 clinical development for the treatment of Duchenne muscular dystrophy (DMD). For information about pamrevlumab studies currently recruiting patients, please visit www.clinicaltrials.gov.