On February 27, 2023 FibroGen, Inc. (NASDAQ: FGEN) reported financial results for the fourth quarter and full year 2022 and provided an update on the company’s recent developments (Press release, FibroGen, FEB 27, 2023, View Source [SID1234627756]).

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"We are proud of the significant progress advancing our clinical pipeline in 2022 and excited and well-prepared to deliver results from five pivotal phase 3 trials in 2023," said Enrique Conterno, Chief Executive Officer, FibroGen. "FibroGen represents a catalyst-rich opportunity with each of these trials representing an opportunity to provide a novel treatment to address a significant unmet medical need."

Upcoming Milestones:

Pamrevlumab

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Topline data from the LELANTOS-1 Phase 3 study of pamrevlumab in non-ambulatory Duchenne muscular dystrophy (DMD) patients expected 2Q 2023.
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Topline data from the ZEPHYRUS-1 Phase 3 study of pamrevlumab in idiopathic pulmonary fibrosis (IPF) expected mid-2023.
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Topline data from the LELANTOS-2 Phase 3 study of pamrevlumab in ambulatory DMD patients expected 3Q 2023.
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Topline data from the LAPIS Phase 3 study of pamrevlumab in locally advanced unresectable pancreatic cancer (LAPC) expected 1H 2024.
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Topline data from the ZEPHYRUS-2 Phase 3 study of pamrevlumab in IPF expected mid-2024.
Roxadustat

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Topline data from the MATTERHORN Phase 3 study of roxadustat in anemia of myelodysplastic syndromes (MDS) expected 2Q 2023.
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Topline data from the China Phase 3 study of roxadustat for the treatment of chemotherapy-induced anemia (CIA) expected 2Q 2023.
Preclinical Pipeline

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Expect to file up to two INDs: FG-3165 (anti-Gal9 antibody) and FG-3163 (anti-CCR8 antibody) in 2H 2023.

Recent Developments and Key Events of 2022:

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Completed enrollment of the LELANTOS-1 Phase 3 clinical trial of pamrevlumab in non-ambulatory patients with DMD.
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Completed enrollment of the ZEPHYRUS-1 Phase 3 clinical trial of pamrevlumab in patients with IPF.
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Our partner Astellas received approval for roxadustat in Russia for the treatment of adult patients with symptomatic anemia associated with chronic kidney disease (CKD), which triggered a $25 million milestone which FibroGen recorded in 1Q 2022.
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Completed enrollment of the LELANTOS-2 Phase 3 clinical trial of pamrevlumab in ambulatory patients with DMD.
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Completed non-dilutive revenue interest monetization transaction providing $50 million with NovaQuest Capital Management to support our strategic priorities.
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Completed enrollment of the MATTERHORN Phase 3 study of roxadustat in patients with anemia of MDS.
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In 1Q 2023, completed enrollment of the China Phase 3 study of roxadustat in patients with chemotherapy-induced anemia (CIA).
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In 1Q 2023, Partner Eluminex Biosciences implanted the first patient with a biosynthetic cornea in their pivotal clinical trial in China.
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Continuation in the Pancreatic Cancer Action Network’s (PanCAN) Precision PromiseSM adaptive trial platform evaluating pamrevlumab [and standard of care] for patients with metastatic pancreatic cancer.

China:

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Fourth quarter FibroGen’s net product revenue under U.S. GAAP from the sale of roxadustat in China was $23.4 million compared to $5.5 million in the fourth quarter of 2021, an increase of 328%.
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Full year 2022 FibroGen’s net product revenue under U.S. GAAP from the sale of roxadustat in China was $82.9 million compared to $47.6 million in the full year 2021, an increase of 74%.
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Fourth quarter total roxadustat net sales in China1 by FibroGen and the distribution entity jointly owned by FibroGen and AstraZeneca (JDE) was $53.1 million, compared to $32.0 million in the fourth quarter of 2021.
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Full year 2022 total roxadustat net sales in China1 by FibroGen and the JDE was $208.8 million, compared to $186.1 million in the full year 2021, 12% growth in net sales driven by over 80% growth in volume.
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Roxadustat continues to be the number one brand based on value share in the anemia of CKD market in China.

Financial:

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Total revenue for the fourth quarter of 2022 was $34.4 million, as compared to $16.5 million for the fourth quarter of 2021.
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Total revenue for 2022 was $140.7 million as compared to $235.3 million in 2021, which included $120 million of milestone payments from Astellas related to the EU approval of roxadustat.
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Net loss for the fourth quarter of 2022 was $66.2 million, or $0.70 net loss per basic and diluted share, compared to a net loss of $134.1 million, or $1.45 net loss per basic and diluted share one year ago.
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Net loss for the year was $293.7 million, or $3.14 net loss per basic and diluted share, compared to a net loss of $290.0 million, or $3.14 net loss per basic and diluted share one year ago.
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At December 31, 2022, FibroGen had $442.7 million in cash – defined as cash, cash equivalents, investments, and accounts receivable.
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Going forward, we believe we are funded through multiple key clinical milestones and we expect our cash, cash equivalents, investments, and accounts receivable to be sufficient to fund our operating plans into the second half of 2024 even without additional financing.

Conference Call and Webcast Details

FibroGen will host a conference call and webcast today, Monday, February 27, 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 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).

1 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.