FibroGen(FGEN) - 2024 Q3 - Quarterly Results

Company Highlights & Strategic Overview FibroGen's Q3 2024 highlights include strong Roxadustat growth, cost reductions, and key upcoming clinical milestones Third Quarter 2024 Highlights FibroGen achieved significant financial and operational progress in Q3 2024, including positive FG-3246 clinical trial expectations, strong Roxadustat growth in China, and substantial completion of US cost reduction plans - Topline results for the Phase II study of FG-3246 (CD46-targeted ADC) combined with enzalutamide for mCRPC are expected in the first half of 2025, with a Phase II single-agent dose optimization study anticipated to start in the first quarter of 2025[1] - The company has transformed into a leaner, more focused organization, achieving significant cost savings, with the US cost reduction plan expected to be substantially complete by end of 2024[1][2] Key Financial and Operational Data for Third Quarter 2024 | Metric | Q3 2024 | Q3 2023 | Year-over-Year Growth | | :--- | :--- | :--- | :--- | | Total Net Revenue | $46.3 million | $40.1 million | 15% | | China Roxadustat Net Sales | $96.6 million | $77.1 million | 25% | | China Roxadustat Volume Growth | - | - | 34% | | Cash, Cash Equivalents, and Accounts Receivable | $160.0 million | - | - | Recent Developments and Key Events of Third Quarter 2024 This quarter, FibroGen made progress in cost control, but two key pamrevlumab clinical trials failed to meet their primary endpoints - Substantial progress has been made on the US cost reduction plan, expected to be largely complete by end of 2024[3] - The PanCAN Precision Promise Phase II/III adaptive platform trial of pamrevlumab for metastatic pancreatic ductal adenocarcinoma (mPDAC) did not meet its primary endpoint[3] - The LAPIS Phase III study of pamrevlumab for locally advanced, unresectable pancreatic cancer (LAPC) did not meet its primary endpoint[3] Upcoming Milestones The company anticipates several key clinical and regulatory milestones in the first half of 2025, including Roxadustat's new indication approval in China and FG-3246 clinical trial progress - A decision on Roxadustat's approval for chemotherapy-induced anemia (CIA) in China is expected in early 2025, with a $10 million milestone payment from AstraZeneca upon approval[4] - Topline results for the Phase II study of FG-3246 combined with enzalutamide for mCRPC are expected in the first half of 2025[4] - A Phase II single-agent dose optimization study of FG-3246 for mCRPC is expected to start in the first quarter of 2025, including a sub-study of FG-3180 to assess CD46 expression and response to FG-3246[4] Operational and Financial Review FibroGen's Q3 2024 featured strong Roxadustat sales in China, revenue growth, and a significantly reduced net loss, supported by cash reserves China Roxadustat Performance Roxadustat demonstrated strong performance in the Chinese market, with significant Q3 growth in FibroGen's net product revenue and total sales, maintaining its leading position in the CKD anemia market China Roxadustat Sales Data | Metric | Q3 2024 | Q3 2023 | Year-over-Year Growth | | :--- | :--- | :--- | :--- | | FibroGen Net Product Revenue (U.S. GAAP) | $46.2 million | $29.4 million | 57% | | FibroGen and JDE Total Sales | $96.6 million | $77.1 million | 25% | | Volume Growth | - | - | 34% | - Roxadustat continues to hold the number one brand position by value share in the China CKD anemia market[5] - Reaffirmed 2024 full-year FibroGen net product revenue (U.S. GAAP) guidance of $135 million to $150 million, representing full-year FibroGen and JDE total sales of Roxadustat in China of $330 million to $350 million[5] Third Quarter 2024 Financial Results FibroGen achieved total revenue growth and significantly reduced net loss in Q3 2024, with sufficient cash reserves expected to support operations through 2026 Key Financial Data for Third Quarter 2024 | Metric | Q3 2024 | Q3 2023 | Year-over-Year Change | | :--- | :--- | :--- | :--- | | Total Revenue | $46.3 million | $40.1 million | 15% Increase | | Net Loss | $17.1 million | $63.6 million | 73% Narrowing of Loss | | Net Loss Per Share, Basic and Diluted | $0.17 | $0.65 | 73% Narrowing of Loss | - As of September 30, 2024, FibroGen held $160.0 million in cash, cash equivalents, and accounts receivable[6] - Assuming additional cash repatriation from China operations, the company expects its cash, cash equivalents, and accounts receivable to be sufficient to support its operating plan through 2026[6] About the Company and Products FibroGen is a biopharmaceutical company focused on oncology, with Roxadustat approved globally and FG-3246 in clinical development About Roxadustat Roxadustat is an oral HIF-PH inhibitor that treats anemia by promoting erythropoiesis, approved globally for CKD anemia, and under development for chemotherapy-induced anemia - Roxadustat is an oral medication, the first in a new class of HIF-PH inhibitors, that promotes erythropoiesis by increasing endogenous erythropoietin production, improving iron absorption and mobilization, and downregulating hepcidin[8] - Roxadustat is approved in China, Europe, Japan, and many other countries for the treatment of anemia in adult patients with CKD, both on dialysis and not on dialysis[8] - Roxadustat is in clinical development for chemotherapy-induced anemia (CIA), with its supplemental New Drug Application (sNDA) accepted by Chinese health authorities[8] About FibroGen FibroGen is a biopharmaceutical company focused on accelerating new therapeutic development in the forefront of cancer biology, with its main product Roxadustat approved globally and an innovative oncology pipeline including FG-3246 - FibroGen, Inc. is a biopharmaceutical company focused on accelerating new therapeutic development in the forefront of cancer biology[9] - Roxadustat (Evrenzo™) is approved in China, Europe, Japan, and many other countries for the treatment of anemia in adult patients with chronic kidney disease (CKD), both on dialysis and not on dialysis[9] - FG-3246 (FOR46), a first-in-class CD46-targeted antibody-drug conjugate (ADC), is being developed for metastatic castration-resistant prostate cancer, with the program also including the development of a related CD46-targeted PET imaging agent, FG-3180[9] Financial Statements FibroGen's Q3 2024 financial statements show decreased assets, a significant net loss reduction, and improved operating expenses year-over-year Condensed Consolidated Balance Sheets As of September 30, 2024, FibroGen's total assets were $264 million, a decrease from $424 million at year-end 2023, primarily reflecting reduced short-term investments and total liabilities Condensed Consolidated Balance Sheets (Excerpt) | Item | September 30, 2024 (Unaudited) | December 31, 2023 (Audited) | | :--- | :--- | :--- | | Cash and cash equivalents | $131,003 thousand | $113,688 thousand | | Short-term investments | - | $121,898 thousand | | Accounts receivable, net | $29,030 thousand | $12,553 thousand | | Inventories | $23,937 thousand | $41,565 thousand | | Total assets | $264,421 thousand | $423,529 thousand | | Total liabilities | $466,121 thousand | $585,728 thousand | | Total stockholders' deficit attributable to FibroGen | $(243,667) thousand | $(204,166) thousand | Condensed Consolidated Statements of Operations In Q3 2024, FibroGen's total revenue grew by 15% year-over-year, with net loss significantly narrowing by 73%, primarily due to substantial reductions in R&D and SG&A expenses Condensed Consolidated Statements of Operations (Excerpt) | Item | Q3 2024 | Q3 2023 | Nine Months Ended Sep 30, 2024 | Nine Months Ended Sep 30, 2023 | | :--- | :--- | :--- | :--- | :--- | | License revenue | $0 | $2,649 thousand | $0 | $9,649 thousand | | Development and other revenue | $385 thousand | $6,775 thousand | $1,532 thousand | $15,825 thousand | | Product revenue, net | $46,210 thousand | $29,390 thousand | $126,391 thousand | $77,439 thousand | | Total revenue | $46,333 thousand | $40,134 thousand | $152,877 thousand | $120,614 thousand | | Research and development expenses | $21,708 thousand | $61,194 thousand | $94,206 thousand | $231,158 thousand | | Selling, general and administrative expenses | $17,554 thousand | $25,573 thousand | $62,650 thousand | $91,029 thousand | | Loss from operations | $(16,778) thousand | $(63,482) thousand | $(58,760) thousand | $(227,620) thousand | | Net loss | $(17,084) thousand | $(63,615) thousand | $(65,561) thousand | $(228,000) thousand | | Net loss per share, basic and diluted | $(0.17) | $(0.65) | $(0.66) | $(2.35) | Additional Information This section provides details on the Q3 2024 earnings call, forward-looking statements, and investor contact information Conference Call and Webcast Details FibroGen management held a conference call and webcast on November 12, 2024, to discuss financial results and provide business updates - The conference call and webcast were held on November 12, 2024, at 5:00 PM ET[7] - Participants could access the conference call by dialing 1-877-300-8521 (US) or 1-412-317-6026 (International)[7] - The webcast was accessible via the 'Events and Presentation' page on the company's website[7] Forward-Looking Statements This press release contains forward-looking statements regarding FibroGen's future strategies, plans, and prospects, which involve risks and uncertainties where actual results may differ materially from expectations - This press release contains forward-looking statements regarding FibroGen's strategies, future plans, and prospects, including its commercial products and clinical programs[11] - These forward-looking statements are generally identified by words such as 'may,' 'will,' 'should,' 'expect,' 'anticipate,' 'plan,' 'intend,' 'believe,' 'estimate,' 'predict,' 'potential,' 'continue,' or the negative of these terms or similar expressions[11] - Actual results may differ materially from those indicated by these forward-looking statements due to risks and uncertainties related to the ongoing progress and timing of various programs, and investors should not place undue reliance on these statements[11] Investor Inquiries Investors with inquiries may contact David DeLucia, Vice President, Corporate Financial Planning/Investor Relations - Investors with inquiries may contact David DeLucia, Vice President, Corporate Financial Planning/Investor Relations[14] - Contact email is ir@fibrogen.com[14]