On February 26, 2024 FibroGen, Inc. (NASDAQ: FGEN) reported financial results for the fourth quarter and full year 2023 and provided an update on the company’s recent developments (Press release, FibroGen, FEB 26, 2024, View Source [SID1234640449]).
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"We are extremely excited about the company’s prospects in 2024," said Thane Wettig, Chief Executive Officer, FibroGen. "In this year alone, we will obtain data read-outs from our two late-stage pancreatic cancer trials, start a Phase 2 metastatic castration-resistant prostate cancer trial, file an immuno-oncology IND, and potentially receive approval for roxadustat in chemotherapy-induced anemia in China. Furthermore, the continued strength of our China business, accelerated realization of our corporate cost reduction program, and our strong balance sheet provide us a cash runway into 2026. These unique and exciting programs, combined with the quality of our talented colleagues, provide a strong foundation to create significant value for shareholders relative to our current valuation."
Upcoming Milestones:
Pamrevlumab
Topline data from the PanCAN Precision Promise℠ Phase 2/3 study of pamrevlumab in metastatic pancreatic cancer expected in 2Q 2024.
Topline data from the LAPIS Phase 3 study of pamrevlumab in locally advanced unresectable pancreatic cancer (LAPC) expected in 2Q 2024.
Roxadustat
Expect approval decision for roxadustat in chemotherapy-induced anemia (CIA) in China in mid-2024. If approved, FibroGen will receive a $10M milestone payment from AstraZeneca.
Oncology Pipeline
Additional data from Phase 1 monotherapy study of FG-3246 in metastatic castration-resistant prostate cancer (mCRPC) expected in 1Q 2024.
Anticipate the initiation of a Phase 2 study of FG-3246 in mCRPC in 2H 2024.
Anticipate the filing of two INDs: FG-3165 (anti-Gal9 antibody) in 1Q 2024 and FG-3175 (anti-CCR8 antibody) in 2025.
Recent Developments and Key Highlights of 2023:
Pamrevlumab
Announced graduation and completion of the pamrevlumab arm in Precision Promise℠, Pancreatic Cancer Action Network’s Phase 2/3 adaptive platform trial for metastatic pancreatic cancer.
Pamrevlumab, in Stage 1 of the trial, achieved a protocol pre-specified ≥ 35% predictive probability of success for the primary endpoint of overall survival at the completion of the trial.
Roxadustat
Regained all rights to roxadustat from AstraZeneca in the United States and other AstraZeneca territories, except China and South Korea.
Presented data from Phase 3 MATTERHORN study of roxadustat in patients with anemia of lower risk transfusion-dependent myelodysplastic syndromes at American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.
Corporate
Thane Wettig appointed Chief Executive Officer.
Successful execution of cost reduction plan, resulting in a reduction of total annualized expenses of $120 million.
China:
Fourth quarter FibroGen’s net product revenue under U.S. GAAP from the sale of roxadustat in China was $23.5 million compared to $23.4 million in the fourth quarter of 2022.
Full year 2023 FibroGen’s net product revenue under U.S. GAAP from the sale of roxadustat in China was $100.9 million compared to $82.9 million in the full year 2022, an increase of 22%.
Fourth quarter total roxadustat net sales in China¹ by FibroGen and the distribution entity jointly owned by FibroGen and AstraZeneca (JDE) was $66.5 million, compared to $53.1 million in the fourth quarter of 2022, an increase of 25%.
Full year 2023 total roxadustat net sales in China¹ by FibroGen and the JDE was $284.1 million, compared to $208.8 million in the full year 2022, an increase of 36%, driven by over 41% growth in volume.
Roxadustat continues to be the number one brand based on value share in the anemia of CKD market in China and has secured renewal on the National Reimbursement Drug List.
For 2024, we anticipate FibroGen’s full year net product revenue under U.S. GAAP to range between $120 million to $135 million, representing full year roxadustat net sales in China¹ by FibroGen and the JDE to range between $300 million to $340 million.
Financial:
Total revenue for the fourth quarter of 2023 was $27.1 million, as compared to $34.4 million for the fourth quarter of 2022. Reduction primarily driven by the change in net product revenue assumptions under U.S. GAAP and drug product revenue shipment timing.
Total revenue for full year 2023 was $147.8 million as compared to $140.7 million in 2022.
Net loss for the fourth quarter of 2023 was $56.2 million, or $0.57 net loss per basic and diluted share, compared to a net loss of $66.2 million, or $0.70 net loss per basic and diluted share one year ago.
Net loss for the year was $284.2 million, or $2.92 net loss per basic and diluted share, compared to a net loss of $293.7 million, or $3.14 net loss per basic and diluted share one year ago.
At December 31, 2023, FibroGen had $248.1 million in cash – defined as cash, cash equivalents, investments, and accounts receivable.
We expect our cash, cash equivalents, investments, and accounts receivable to be sufficient to fund our operating plans into 2026.
Conference Call and Webcast Details
FibroGen will host a conference call and webcast today, Monday, February 26, 2024, at 5:00 PM Eastern Time to discuss financial results and provide a business update. Interested parties may access a live audio webcast of the conference call via the "Investor Relations" page of the Company’s website at www.fibrogen.com. To access the call by phone, please go to this link (registration link), and you will be provided with dial in details. To avoid delays, we encourage participants to dial into the conference call fifteen minutes ahead of the scheduled start time. A replay of the webcast will also be available for a limited time at the following link (webcast replay).
About Pamrevlumab
Pamrevlumab is a potential first-in-class antibody being developed by FibroGen to inhibit the activity of connective tissue growth factor (CTGF). Pamrevlumab is in Phase 3 clinical development for the treatment of locally advanced unresectable pancreatic cancer (LAPC) and in Phase 2/3 for the treatment of metastatic pancreatic cancer. The U.S. Food and Drug Administration has granted Orphan Drug Designation, and Fast Track designation to pamrevlumab for the treatment of patients with LAPC. Pamrevlumab has demonstrated a safety and tolerability profile that has supported ongoing clinical investigation in LAPC and metastatic pancreatic cancer. Pamrevlumab is an investigational drug and not approved for marketing by any regulatory authority. For information about our pamrevlumab studies please visit www.clinicaltrials.gov.
About Roxadustat
Roxadustat, an oral medication, is the first in a new class of medicines comprising 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 in clinical development for chemotherapy-induced anemia (CIA) and a Supplemental New Drug Application (sNDA) has been accepted by the China Health Authority.
Roxadustat is approved in China, Europe, Japan, and numerous other countries for the treatment of anemia of CKD in adult patients on dialysis (DD) and not on dialysis (NDD). Several other licensing applications for roxadustat have been submitted by partners, Astellas and AstraZeneca, to regulatory authorities across the globe, and are currently under 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. AstraZeneca and FibroGen continue to collaborate on the development and commercialization of roxadustat in China.