[PART I—FINANCIAL INFORMATION](index=2&type=section&id=PART%20I%E2%80%94FINANCIAL%20INFORMATION) [Item 1. Condensed Consolidated Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) Unaudited Q1 2021 consolidated financial statements report a net loss of $71.8 million, with decreased assets and increased product revenue Condensed Consolidated Balance Sheet Data (in thousands) | Account | March 31, 2021 | December 31, 2020 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $433,508 | $678,393 | | Total current assets | $621,694 | $755,110 | | Total assets | $787,301 | $826,840 | | **Liabilities & Equity** | | | | Total current liabilities | $167,047 | $163,187 | | Total liabilities | $397,028 | $385,391 | | Total stockholders' equity | $371,002 | $422,178 | | Total liabilities, stockholders' equity and non-controlling interests | $787,301 | $826,840 | Condensed Consolidated Statement of Operations Data (in thousands) | Account | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :--- | :--- | :--- | | Total revenue | $38,429 | $24,401 | | Total operating costs and expenses | $108,856 | $105,475 | | Loss from operations | $(70,427) | $(81,074) | | Net loss | $(71,755) | $(78,348) | | Net loss per share - basic and diluted | $(0.78) | $(0.89) | Condensed Consolidated Statement of Cash Flows Data (in thousands) | Activity | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | $(44,984) | $(59,486) | | Net cash provided by (used in) investing activities | $(196,719) | $56,009 | | Net cash used in financing activities | $(2,080) | $(1,190) | | Net decrease in cash and cash equivalents | $(244,885) | $(4,706) | [Notes to the Condensed Consolidated Financial Statements (Unaudited)](index=10&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) Notes detail accounting policies, collaboration agreements, and financial components, highlighting roxadustat revenue, Falikang joint venture, and legal proceedings - The company's lead product, **roxadustat**, is being commercialized in China and Japan for anemia caused by CKD. An NDA is under review by the U.S. FDA, with an advisory committee meeting scheduled for July 15, 2021. **Pamrevlumab** is in **Phase 3** development for IPF, pancreatic cancer, and DMD[36](index=36&type=chunk)[37](index=37&type=chunk)[38](index=38&type=chunk) - In **January 2021**, the joint venture **Falikang** (with AstraZeneca) became operational and began handling most roxadustat distribution in China. FibroGen recognizes revenue from sales to Falikang based on a complex transaction price calculation that includes upfront fees, milestones, and profit sharing[52](index=52&type=chunk)[54](index=54&type=chunk)[93](index=93&type=chunk) Product Revenue, Net (in thousands) | Category | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :--- | :--- | :--- | | Direct sales revenue, net | $4,956 | $4,955 | | Sales to Falikang revenue, net | $10,406 | $0 | | **Total product revenue, net** | **$15,362** | **$4,955** | - FibroGen accounts for its **51.1%** owned joint entity, **Falikang**, as a variable interest entity (VIE) under the **equity method**, as AstraZeneca is deemed to have the power to direct its most significant activities. FibroGen is **not the primary beneficiary** and does not consolidate Falikang[102](index=102&type=chunk)[103](index=103&type=chunk) - As of March 31, 2021, the company had non-cancelable purchase obligations of **$93.9 million**, primarily for the manufacture and supply of roxadustat (**$30.4 million**) and pamrevlumab (**$57.5 million**)[135](index=135&type=chunk) - In **April and May 2021**, **multiple securities class action complaints** were filed against FibroGen and certain officers, alleging false and misleading statements regarding Phase 3 clinical data and FDA approval prospects for roxadustat[140](index=140&type=chunk)[302](index=302&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=28&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Q1 2021 financial results, noting increased revenue, decreased net loss, and progress in key drug candidates and collaborations Financial Highlights (in thousands) | Metric | Q1 2021 | Q1 2020 | | :--- | :--- | :--- | | Total Revenue | $38,429 | $24,401 | | Operating Costs & Expenses | $108,856 | $105,475 | | Net Loss | $(71,755) | $(78,348) | | Net Loss Per Share | $(0.78) | $(0.89) | - Roxadustat commercialization is expanding in China, reaching hospitals representing **~74%** of the CKD anemia market opportunity. In the U.S., an FDA advisory committee meeting is scheduled for **July 15, 2021**. An EMA approval decision is expected **mid-2021**[160](index=160&type=chunk)[162](index=162&type=chunk)[163](index=163&type=chunk) - **Pamrevlumab** is advancing in **Phase 3** trials for IPF (ZEPHYRUS-1 & 2), locally advanced pancreatic cancer (LAPIS), and DMD (LELANTOS-1 & 2). The FDA granted **Rare Pediatric Disease** and **Fast Track** designations for DMD[170](index=170&type=chunk)[171](index=171&type=chunk)[172](index=172&type=chunk) Research and Development Expenses by Program (in thousands) | Product Candidate | Phase of Development | Q1 2021 | Q1 2020 | | :--- | :--- | :--- | :--- | | Roxadustat | Phase 3 | $26,524 | $26,038 | | Pamrevlumab | Phase 2/3 | $35,370 | $22,100 | | Other R&D expenses | | $12,782 | $6,764 | | **Total R&D expenses** | | **$74,676** | **$54,902** | - SG&A expenses decreased by **$18.8 million** (**38%**) YoY, primarily due to a **$24.6 million** reduction in outside service expenses related to a change in the calculation of co-promotion expenses with AstraZeneca in China following the China Amendment[238](index=238&type=chunk) - The company believes its cash, cash equivalents, investments, and receivables of **$678.5 million** as of March 31, 2021, are sufficient to fund operations for **at least the next 12 months**[158](index=158&type=chunk)[254](index=254&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=45&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) No material changes to market risk exposure were reported for Q1 2021 compared to the 2020 Annual Report - There were **no material changes** to the company's market risk exposure during Q1 2021[288](index=288&type=chunk) [Item 4. Controls and Procedures](index=45&type=section&id=Item%204.%20Controls%20and%20Procedures) Disclosure controls and procedures were deemed ineffective as of March 31, 2021, due to material weaknesses in risk assessment and revenue recognition controls - The CEO and CFO concluded that disclosure controls and procedures were **not effective** as of March 31, 2021[290](index=290&type=chunk) - The ineffectiveness is due to **material weaknesses** identified as of September 30, 2020, related to risk assessment and controls over drug product revenue recognition. These weaknesses **did not result in material misstatements**[292](index=292&type=chunk)[294](index=294&type=chunk) - A **remediation plan is underway**, which includes a comprehensive risk assessment process, designing and implementing new controls, and hiring additional accounting and internal audit staff[296](index=296&type=chunk)[297](index=297&type=chunk) [PART II—OTHER INFORMATION](index=47&type=section&id=PART%20II%E2%80%94OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=47&type=section&id=Item%201.%20Legal%20Proceedings) Multiple securities class action lawsuits were filed in Q2 2021 alleging false statements regarding roxadustat's clinical data and FDA approval prospects - In **April and May 2021**, **five putative securities class action complaints** were filed against FibroGen and certain executives[302](index=302&type=chunk) - The lawsuits allege **materially false and misleading statements** regarding roxadustat's Phase 3 data and FDA approval prospects between late 2017 and April 2021[302](index=302&type=chunk) - The company believes the claims are **without merit** and intends to **vigorously defend** against them, but notes that litigation is inherently uncertain[302](index=302&type=chunk) [Item 1A. Risk Factors](index=47&type=section&id=Item%201A.%20Risk%20Factors) Key risks include product dependence, regulatory uncertainty, competition, supply chain issues, COVID-19 impact, and internal control weaknesses - The company is **substantially dependent** on the success of its lead products, roxadustat and pamrevlumab, and has **limited commercialization experience**[305](index=305&type=chunk)[308](index=308&type=chunk) - The upcoming FDA Cardiovascular and Renal Drugs Advisory Committee meeting for roxadustat, tentatively scheduled for **July 15, 2021**, could **significantly affect** its approvability and label in CKD anemia[320](index=320&type=chunk) - The ongoing COVID-19 pandemic could continue to **adversely affect business** by delaying clinical programs and timelines, disrupting the supply chain, and impacting productivity[370](index=370&type=chunk) - The company has identified **material weaknesses** in its internal control over financial reporting related to risk assessment and revenue recognition, which could result in **material misstatements** if not remediated[440](index=440&type=chunk)[441](index=441&type=chunk) - The company faces **substantial competition** for roxadustat from established ESAs and other HIF-PH inhibitors in development by companies like GSK, Bayer, and Akebia[343](index=343&type=chunk)[345](index=345&type=chunk) - Operations in China are subject to **significant risks**, including a highly regulated and changing pharmaceutical industry, pricing controls, restrictions on cash repatriation, and difficulties in protecting intellectual property[460](index=460&type=chunk)[468](index=468&type=chunk)[469](index=469&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=82&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) All proceeds from the 2014 initial public offering have been fully utilized as described in the prospectus - All proceeds from the company's 2014 initial public offering have been **fully used** as described in the prospectus[527](index=527&type=chunk) [Item 3. Defaults Upon Senior Securities](index=82&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) No defaults upon senior securities were reported [Item 4. Mine Safety Disclosures](index=83&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) No mine safety disclosures are applicable to the company's operations [Item 5. Other Information](index=83&type=section&id=Item%205.%20Other%20Information) No other material information was reported [Item 6. Exhibits](index=83&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the quarterly report, including certifications and new agreements - Lists exhibits filed, including **CEO/CFO certifications** (31.1, 31.2, 32.1) and **new material contracts** like the Astellas EU Supply Agreement (10.2)[532](index=532&type=chunk)

FibroGen, Inc. (NASDAQ:FGEN) Q4 2020 Earnings Conference Call March 1, 2021 5:00 PM ET Company Participants Michael Tung – Investor Relations Executive Enrique Conterno – Chief Executive Officer Mark Eisner – Chief Medical Officer Pat Cotroneo – Chief Financial Officer Conference Call Participants Joel Beatty – Citi Michael Yee – Jefferies Edwin Zhang – H.C. Wainwright Geoffrey Porges – SVB Leerink Annabel Samimy – Stifel Jason Gerberry – Bank of America Yaron Werber – Cowen Andy Hsieh – William Blair Difei ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 OR ☐ TRANSITION 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) | --- | --- | --- | |--------------------------------- ...

FibroGen, Inc. Corporate Presentation November 2020 Forward-Looking Statements 2 This presentation contains "forward-looking" statements that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this presentation, including statements regarding our future financial condition, business strategy, and plans, and objectives of management for future operations, are forward looking statements. These forward-looking statements can generally be identifie ...

Financial Data and Key Metrics Changes - Total revenue for Q3 2020 was $44 million, compared to $33.2 million for Q3 2019, indicating a year-over-year increase [29] - Net income for Q3 2020 was $33 million, or $0.36 per basic share, compared to a net loss of $49.4 million, or $0.57 per basic share, in Q3 2019 [30][34] - Operating costs and expenses were $11.7 million for Q3 2020, down from $86 million in the same period last year [30] Business Line Data and Key Metrics Changes - Roxadustat sales in China reached $22.7 million in Q3 2020, up from $15.7 million in Q2 2020, reflecting strong market uptake [16] - Development revenue contributed $20.7 million, and sales of bulk drug product to AstraZeneca accounted for $2.3 million [29] Market Data and Key Metrics Changes - Roxadustat was listed in hospitals representing approximately 55% of the CKD anemia market opportunity in China by the end of Q3 2020, up from 45% at the end of Q2 2020 [17] - The number of patients treated with Roxadustat in China more than doubled from 40,000 to 90,000 from Q2 to Q3 2020, although sales did not match this rise [47][50] Company Strategy and Development Direction - The company aims to make Roxadustat the standard of care for treating CKD anemia in China and is preparing for its launch in the U.S. and other countries [18][19] - A new collaboration agreement with AstraZeneca is expected to improve profitability and predictability for the Roxadustat franchise [31] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in navigating challenges posed by the COVID-19 pandemic and highlighted a strong cash position of approximately $720 million at the end of Q3 2020 [36] - The company anticipates $245 million in potential milestones over the next nine months for expected U.S. and EU approvals [34] Other Important Information - The company is conducting ongoing Phase IIIb clinical trials for Roxadustat in the U.S. dialysis setting, with results expected in the first half of 2021 [71] - The company has a strong pipeline, with top-line data for various trials expected in 2021 and 2022 [24][27] Q&A Session Summary Question: Implications of a black box warning for Roxadustat - Management indicated that a black box warning could slow initial uptake but may not significantly impact long-term market potential, especially in the dialysis setting where similar warnings exist for current treatments [40][42] Question: Market dynamics in China regarding patient numbers and sales - Management clarified that the reported patient numbers are cumulative and do not directly correlate with sales, emphasizing strong underlying business fundamentals [49][51] Question: Launch trajectory for Roxadustat in dialysis and non-dialysis populations - Management expects a rapid ramp-up in the dialysis population and is focused on educating the market about the importance of treating anemia in the non-dialysis population [55][58] Question: Update on pamrevlumab pancreatic cancer study - Top-line resection data for the pamrevlumab study is expected in the second half of 2022 [66] Question: Engagement with large dialysis providers in the U.S. - Management confirmed ongoing discussions with large dialysis providers and expressed confidence in securing contracts post-approval [79] Question: Competitive landscape and LDL reduction data - Management believes that while LDL reduction data is beneficial, the overall cardiovascular safety profile is more critical for the product's acceptance [66][90]

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 quarterly period ended September 30, 2020 OR ☐ TRANSITION 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) | --- | --- | --- | |-------------------------- ...

FibroGen, Inc. Corporate Presentation September 2020 Forward-Looking Statements 2 This presentation contains "forward-looking" statements that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this presentation, including statements regarding our future financial condition, business strategy, and plans, and objectives of management for future operations, are forward looking statements. These forward-looking statements can generally be identifi ...

FibroGen, Inc. (NASDAQ:FGEN) Q2 2020 Earnings Conference Call August 6, 2020 5:00 PM ET Company Participants Michael Tung – Vice President-Corporate Strategy and Investor Relations Enrique Conterno – Chief Executive Officer Pat Cotroneo – Chief Financial Officer Chris Chung – Senior Vice President-China Operations Thane Wettig – Chief Commercial Officer Peony Yu – Chief Medical Officer Conference Call Participants Geoffrey Porges – SVB Leerink Michael Yee – Jefferies Joel Beatty – Citi Jason Gerberry – Bank ...

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 quarterly period ended June 30, 2020 OR ☐ TRANSITION 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) | --- | --- | --- | |------------------------------- ...

FibroGen, Inc. (NASDAQ:FGEN) Q1 2020 Earnings Conference Call May 7, 2020 5:00 PM ET Corporate Participants Mike Tung - Investor Relations Enrique Conterno - Chief Executive Officer Peony Yu - Chief Medical Officer Chris Chung - Senior Vice President, China Operations Elias Kouchakji - Senior Vice President, Clinical Development, Drug Safety and Pharmacovigilance Pat Cotroneo - Chief Financial Officer Conference Call Participants Michael Yee - Jefferies Geoffrey Porges - SVB Leerink Jason Gerberry - Bank of ...