On November 6, 2023 FibroGen, Inc. (NASDAQ: FGEN) reported financial results for the third quarter 2023 and provided an update on the Company’s recent developments (Press release, FibroGen, NOV 6, 2023, View Source [SID1234637024]).
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"Today, we reported another quarter of strong roxadustat volume growth in China, achieving the highest ever value share, at 42%, in the anemia of CKD category," said Thane Wettig, Chief Executive Officer, FibroGen. "The continued strength of our China business, sooner than expected realization of our corporate cost reduction efforts and our strong balance sheet provide us a cash runway into 2026. Over the next 12 months, we will obtain data read-outs from our two late-stage pancreatic cancer trials, start a Phase 2 metastatic castrate-resistant prostate cancer trial, and file two immuno-oncology INDs. 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."
Recent Developments and Key Events of Third Quarter 2023:
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Appointed Thane Wettig as Chief Executive Officer.
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Supplemental New Drug Application (sNDA) accepted by the China Health Authority for roxadustat for the treatment of patients with chemotherapy-induced anemia (CIA). Expect approval decision of CIA in China in mid-2024.
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Successful implementation of cost reduction plan, now resulting in an expected reduction of total annualized expenses of $120 million.
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Reported negative topline results from the LELANTOS-2 Phase 3 study of pamrevlumab for the treatment of ambulatory patients with Duchenne muscular dystrophy (DMD).
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Presented Phase 3 data of roxadustat for CIA in patients with non-myeloid malignancies in an oral presentation at the European Society for Medical Oncology Congress 2023.
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FibroGen and its partners presented five roxadustat abstracts, including four poster presentations and one late-breaker poster presentation, at the recent American Society of Nephrology (ASN) Kidney Week 2023 conference.
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Presented preclinical data for the FG-3165 anti-Gal9 antibody program at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting 2023.
China Performance:
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Achieved third quarter net product revenue under U.S. GAAP from the sale of roxadustat in China of $29.4 million compared to $17.4 million in the third quarter of 2022, an increase of 69% year over year.
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Achieved third quarter total roxadustat net sales in China1 by FibroGen and the distribution entity (JDE) jointly owned by FibroGen and AstraZeneca of $77.1 million, compared to $59.0 million in the third quarter of 2022, an increase of 31% year over year, driven by 37% growth in volume.
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Roxadustat continues to be the number one brand based on value share in the anemia of chronic kidney disease market in China. Total roxadustat net sales in China includes sales made by the distribution entity as well as FibroGen China’s direct sales, each to its own distributors. The distribution entity jointly owned by AstraZeneca and FibroGen is not consolidated into FibroGen’s financial statements.
Upcoming Milestones:
Pamrevlumab
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Topline data from the LAPIS Phase 3 study of pamrevlumab in locally advanced unresectable pancreatic cancer (LAPC) expected in 1Q 2024.
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Topline data from the PanCAN Precision PromiseSM Phase 2/3 study of pamrevlumab in metastatic pancreatic cancer expected in 1H 2024.
Oncology Pipeline
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Expect topline clinical trial results from Phase 1 monotherapy trial of FG-3246, a first-in-class antibody-drug conjugate (ADC) targeting a novel epitope on CD46 for metastatic castration-resistant prostate cancer (mCRPC) by 1Q 2024.
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Anticipate the initiation of a Phase 2 trial of FG-3246 for mCRPC in 2H 2024.
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Anticipate the filing of two INDs: FG-3165 (anti-Gal9 antibody) in 1Q 2024 and FG-3175 (anti-CCR8 antibody) in 2H 2024.
Financial:
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Total revenue for the third quarter of 2023 was $40.1 million, as compared to $15.7 million for the third quarter of 2022, an increase of 155% year over year.
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Net loss for the third quarter of 2023 was $63.6 million, or $0.65 net loss per basic and diluted share, compared to a net loss of $91.7 million, or $0.98 net loss per basic and diluted share one year ago.
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Restructuring charge for the third quarter of 2023 was $12.6 million, or $0.13 impact to net loss per basic and diluted share, resulting from the reduction in U.S. workforce announced in July 2023.
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At September 30, 2023, cash – defined as cash, cash equivalents, investments, and accounts receivable – was $283.0 million.
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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, November 6, 2023, 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 in to 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. FibroGen and AstraZeneca are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in the U.S., China, and other markets not licensed to Astellas.