UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-36740 FIBROGEN, INC. (Exact name of registrant as specified in its charter) For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 San Francisco, CA 94158 (Address of Principal Execu ...

[Executive Summary & Business Update](index=1&type=section&id=Executive%20Summary%20%26%20Business%20Update) FibroGen reported a strong start to 2024, highlighted by compelling Phase 1 data for FG-3246 and robust growth of its roxadustat business in China - CEO Thane Wettig highlighted a strong start to 2024, driven by compelling Phase 1 data for FG-3246 and continued robust growth of roxadustat in China[3](index=3&type=chunk) - The company reaffirms its cash runway into **2026**, supported by a cash, cash equivalents, investments, and accounts receivable balance of **$214.7 million**[3](index=3&type=chunk)[6](index=6&type=chunk)[12](index=12&type=chunk) - First quarter net revenue grew **55% year-over-year**, driven by roxadustat performance in China and a one-time drug product revenue recognition from the termination of the US/RoW AstraZeneca agreement[6](index=6&type=chunk)[12](index=12&type=chunk) [Key Milestones and Pipeline Developments](index=1&type=section&id=Key%20Milestones%20and%20Pipeline%20Developments) FibroGen outlined key upcoming milestones, including topline data for two pamrevlumab Phase 3 studies in pancreatic cancer and an approval decision for roxadustat in China [Pamrevlumab](index=1&type=section&id=Pamrevlumab) Topline data from two late-stage pamrevlumab trials in pancreatic cancer are expected in mid-2024 and Q3 2024 - Topline data from the PanCAN Precision Promise Phase 2/3 study in metastatic pancreatic cancer is anticipated in **mid-2024**[6](index=6&type=chunk)[7](index=7&type=chunk) - Topline data from the LAPIS Phase 3 study in locally advanced unresectable pancreatic cancer is expected in **Q3 2024**[6](index=6&type=chunk)[7](index=7&type=chunk) - Pamrevlumab has received Orphan Drug Designation and Fast Track designation from the U.S. FDA for the treatment of LAPC[14](index=14&type=chunk) [Roxadustat](index=1&type=section&id=Roxadustat) Roxadustat sales in China showed robust growth, with an approval decision for chemotherapy-induced anemia (CIA) expected in H2 2024 - An approval decision for roxadustat in chemotherapy-induced anemia (CIA) in China is expected in the **second half of 2024**[4](index=4&type=chunk) - If approved for CIA, FibroGen is set to receive a **$10 million milestone payment** from AstraZeneca[4](index=4&type=chunk) - Roxadustat volume in China grew **39% year-over-year** in the first quarter[6](index=6&type=chunk)[12](index=12&type=chunk) [Oncology Pipeline](index=1&type=section&id=Oncology%20Pipeline) Compelling Phase 1 data for FG-3246 in mCRPC led to a planned Phase 2 study in H2 2024, alongside IND submissions for FG-3165 and FG-3175 - Phase 1 data for FG-3246 in mCRPC showed a median radiographic progression-free survival (rPFS) of **8.7 months** and a **36% rate of PSA reduction (≥ 50%)**[12](index=12&type=chunk) - A Phase 2 monotherapy dose optimization study of FG-3246 in mCRPC is anticipated to start in the **second half of 2024**[7](index=7&type=chunk) - An IND was submitted for FG-3165 (Galectin-9 targeting mAb) in **April 2024**, and an IND filing for FG-3175 (anti-CCR8 mAb) is expected in **2025**[7](index=7&type=chunk)[12](index=12&type=chunk) [Financial Performance](index=2&type=section&id=Financial%20Performance) FibroGen reported total revenues of **$55.9 million** for Q1 2024, a **55% increase year-over-year**, with net loss significantly narrowed to **$32.9 million** [Q1 2024 Financial Highlights](index=2&type=section&id=Q1%202024%20Financial%20Highlights) Total revenue increased **55% year-over-year** to **$55.9 million**, with net loss significantly reduced to **$32.9 million** or **$0.33 per share** Q1 2024 vs Q1 2023 Key Financials | Metric | Q1 2024 | Q1 2023 | Change | | :--- | :--- | :--- | :--- | | Total Revenue | $55.9M | $36.2M | +55% | | Net Loss | ($32.9M) | ($76.7M) | +57% | | Net Loss per Share | ($0.33) | ($0.81) | +59% | Roxadustat China Sales Performance (Q1 2024 vs Q1 2023) | Metric | Q1 2024 | Q1 2023 | Change | | :--- | :--- | :--- | :--- | | FibroGen Net Product Revenue (U.S. GAAP) | $30.5M | $24.2M | +26% | | Total Roxadustat Net Sales in China (incl. JDE) | $79.4M | $64.1M | +24% | - The company reaffirms its full-year 2024 net product revenue guidance under U.S. GAAP to range between **$120 million to $135 million**[12](index=12&type=chunk) - Cash, cash equivalents, investments, and accounts receivable totaled **$214.7 million** at March 31, 2024, supporting operations into **2026**[12](index=12&type=chunk) [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Total revenue increased to **$55.9 million** in Q1 2024, driven by product and one-time drug product revenue, resulting in a reduced net loss of **$32.9 million** Condensed Consolidated Statements of Operations | (In thousands) | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | **Total revenue** | **$55,902** | **$36,161** | | Product revenue, net | $30,538 | $24,161 | | Drug product revenue, net | $24,486 | $2,109 | | **Total operating costs and expenses** | **$86,965** | **$112,252** | | Research and development | $38,392 | $74,486 | | Selling, general and administrative | $22,820 | $34,275 | | **Loss from operations** | **($31,063)** | **($76,091)** | | **Net loss** | **($32,933)** | **($76,705)** | | **Net loss per share - basic and diluted** | **($0.33)** | **($0.81)** | [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to **$365.9 million** as of March 31, 2024, with total liabilities also decreasing to **$552.0 million** Condensed Consolidated Balance Sheet Highlights | (In thousands) | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $105,734 | $113,688 | | Short-term investments | $71,865 | $121,898 | | **Total current assets** | **$278,167** | **$331,559** | | **Total assets** | **$365,868** | **$423,529** | | **Liabilities and Stockholders' Deficit** | | | | **Total current liabilities** | **$196,733** | **$217,668** | | **Total liabilities** | **$552,023** | **$585,728** | | **Total stockholders' deficit** | **($207,635)** | **($183,679)** | [Corporate Information](index=2&type=section&id=Corporate%20Information) FibroGen appointed Deyaa Adib, MD as Chief Medical Officer and provided details for its Q1 2024 conference call and webcast - Appointed Deyaa Adib, MD as the new Chief Medical Officer[9](index=9&type=chunk) - The company is focused on accelerating the development of novel therapies in cancer biology, with key assets including pamrevlumab, roxadustat, and FG-3246[17](index=17&type=chunk)

Topline data from the Pancreatic Cancer Action Network (PanCAN) Precision PromiseSM Phase 2/3 study in metastatic pancreatic cancer anticipated in mid-2024Topline data from LAPIS Phase 3 study in locally advanced unresectable pancreatic cancer anticipated in 3Q 2024Reported compelling data from Phase 1 monotherapy study of FG-3246, a CD46 targeted antibody drug conjugate, in metastatic castration-resistant prostate cancer First quarter net revenue growth of 55% year over year, driven by roxadustat China per ...

FG-3246 demonstrated efficacy in adenocarcinoma selected cohorts receiving biologically active doses of FG-3246 at ≥ 1.2 mg/kg in heavily pre-treated, biomarker unselected patients: Median radiographic progression free survival of 8.7 months PSA50 response in 36% of patients Confirmed radiographic objective response rate of 20%, with a median duration of response of 7.5 months FG-3246 demonstrated an acceptable safety profile; adverse events consistent with those observed in other antibody drug conjugate th ...

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SAN FRANCISCO, March 11, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ:FGEN) today announced the appointment of Deyaa Adib, M.D., an executive leader with almost three decades of oncology development experience, as Senior Vice President & Chief Medical Officer to oversee all global clinical development activities. The appointment is effective March 11, 2024. "Deyaa's leadership and expertise in oncology research and clinical development, particularly in bringing oncology therapeutics to market, will be ke ...

Pamrevlumab in Pancreatic Cancer - Pamrevlumab promotes tumor cell apoptosis and reduces cell proliferation in pancreatic cancer preclinical models[1] - A Phase 1/2 study showed a positive exposure response relationship with pamrevlumab plasma level Cmin ≥150 µg/mL, resulting in a 2x increase in median survival (9.4 vs 4.8 months) (p=0.025) and a >3x increase in one-year survival (37% vs 11%) (p=0.01) [3] - Pamrevlumab is currently in two late-stage studies addressing approximately 90% of diagnosed pancreatic cancer patients [8, 39] - FibroGen has established a standard research agreement with PanCAN for the Pamrevlumab Precision Promise Phase 2/3 study [15] - Topline data from the Precision Promise Phase 2/3 study and the LAPIS Phase 3 study are expected in 2Q 2024 [16, 38] - In the U S, pancreatic cancer represents a multi-billion-dollar commercial opportunity for pamrevlumab [27, 44] Roxadustat - Roxadustat net sales to distributors in China reached $284.1 million in full year 2023, a 36% increase compared to $208.8 million a year ago [49] - Roxadustat maintains category leadership based on dollar sales in the ESA + HIF market [54] - A sNDA for Roxadustat has been accepted in China for Anemia associated with CIA, with an approval decision expected in mid-2024 [61, 88] - In MATTERHORN Phase III Trial, 44.4% of Roxadustat arm achieved TI for ≥56 days by EOT, compared to 19.2% in the placebo arm (p=0.048) [65] FG-3246 - Interim data from a Phase 1 study of FG-3246 in heavily pretreated mCRPC patients showed a 19% ORR and a median duration of response ≥ 16 weeks [74, 79]

Product Dependence - The company is heavily reliant on the success of its lead products, pamrevlumab and roxadustat, for future growth[22] - The company faces substantial competition in the discovery, development, and commercialization of product candidates[22] Regulatory Environment - The regulatory approval process for product candidates is highly uncertain, and the company may not obtain necessary approvals in various jurisdictions[26] - The pharmaceutical industry in China is highly regulated, and changes in regulations could materially affect the company's operations[26] International Operations - The company operates in China through FibroGen Beijing, which holds regulatory licenses for roxadustat and has a drug product manufacturing facility[25] - The company has established operations in China and is seeking to commercialize product candidates outside the U.S., facing various international operational risks[26] Financial Management - As of December 31, 2023, the company reported no material financial assets and liabilities denominated in foreign currencies, indicating low foreign currency risk[596] - The company aims to preserve capital while maximizing income from cash and cash equivalents, primarily investing in commercial paper and money market funds[597] - The company has not entered into any hedging arrangements regarding foreign currency risk or other derivative financial instruments[598] - The company’s future financial condition and results of operations may be adversely affected by fluctuations in foreign currency exchange rates[595]

Exhibit 99.1 FibroGen Reports Fourth Quarter and Full Year 2023 Financial Results SAN FRANCISCO, February 26, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today reported financial results for the fourth quarter and full year 2023 and provided an update on the company's recent developments. "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 cance ...

SAN FRANCISCO, Feb. 05, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ:FGEN) today announced it will host Part I of a virtual KOL investor event series on Tuesday, February 13, 2024 at 10:30 AM ET. To register, click here. The event will feature Andrew Ko, MD (University of California San Francisco (UCSF), UCSF's Helen Diller Family Comprehensive Cancer Center) and Vincent Picozzi, MD, MMM (Virginia Mason Digestive Disease and Cancer Institutes, Virginia Mason Medical Center), who will discuss the unmet me ...