FibroGen, Inc. (NASDAQ:FGEN) Q3 2021 Earnings Conference Call November 9, 2021 5:00 PM ET Company Participants Michael Tung - VP, Corporate Strategy and IR Enrique Conterno - CEO Juan Graham - CFO Mark Eisner - CMO John Hunter - CSO Conference Call Participants Annabel Samimy - Stifel Edwin Zhang - H.C. Wainwright Michael Yee - Jefferies Geoffrey Porges - SVB Leerink Paul Choi - Goldman Sachs Andy Hsieh - William Blair Operator Hello. Thank you for standing by. Welcome to the FibroGen Third Quarter 2021 Fin ...

Financial Performance - Revenue for the three months ended September 30, 2021, was $155.973 million, a significant increase from $44.032 million in the same period of 2020, representing a growth of 253%[169] - Net income for the three months ended September 30, 2021, was $49.798 million, compared to a net income of $33.004 million for the same period in 2020, reflecting a year-over-year increase of 51%[169] - License revenue for Q3 2021 was $116.4 million, a 100% increase compared to the previous year[211] - Total revenue for Q3 2021 increased by $111.9 million, or 254%, compared to the same period last year[216] - Development and other revenue for Q3 2021 was $26.1 million, a 26% increase from $20.7 million in Q3 2020[211] - Product revenue for Q3 2021 was $13.4 million, a decrease of 41% compared to the previous year[211] - Total product revenue, net for the nine months ended September 30, 2021, was $42.2 million, a 3% decrease from $43.3 million in the same period in 2020[225] Operating Costs and Expenses - Operating costs and expenses for the three months ended September 30, 2021, were $104.999 million, up from $11.702 million in the same period of 2020, indicating a substantial increase due to higher sales and marketing expenses[173] - Total operating costs and expenses increased by $93.3 million, or 797%, for the three months ended September 30, 2021, and by $126.9 million, or 52%, for the nine months ended September 30, 2021, compared to the same periods a year ago[233] - Research and development expenses increased by $17.4 million, or 30%, for the three months ended September 30, 2021, and by $98.3 million, or 56%, for the nine months ended September 30, 2021, compared to the same periods a year ago[240][242] - SG&A expenses increased by $74.8 million, or 153%, for the three months ended September 30, 2021, and by $25.0 million, or 39%, for the nine months ended September 30, 2021, compared to the same periods a year ago[244][245] Cash and Investments - Cash and cash equivalents totaled $274.527 million as of September 30, 2021, down from $678.393 million at the end of 2020, a decrease of $403.866 million[169] - As of September 30, 2021, the company had cash and cash equivalents of $274.5 million, with short-term and long-term investments totaling $211.9 million and $142.6 million, respectively[259] - The company reported a net cash used in operating activities of $27.3 million for the nine months ended September 30, 2021, primarily due to a net loss of $155.9 million adjusted for non-operating cash items[263] - For the nine months ended September 30, 2021, net cash used in investing activities was $376.4 million, mainly from purchases of available-for-sale securities totaling $397.9 million[269] Product Development and Regulatory Updates - The FDA issued a complete response letter regarding Roxadustat's NDA for CKD anemia, indicating that it could not be approved in its current form[181] - The company is conducting a Phase 2/3 trial for Roxadustat in anemia associated with myelodysplastic syndromes, with topline data expected between the second half of 2022 and the first half of 2023[182] - Pamrevlumab has received multiple designations from the FDA, including Rare Pediatric Disease designation and Fast Track designation for the treatment of Duchenne muscular dystrophy[187] - The company expects topline overall survival data from the Phase 3 clinical program for pamrevlumab in pancreatic cancer in the first half of 2024[189] - The company expects topline data from the LELANTOS-1 Phase 3 trial in the first half of 2023[191] - The LELANTOS-2 trial is enrolling approximately 70 ambulatory DMD patients, with a treatment period of 52 weeks[192] Collaboration and Licensing Agreements - The company recognized $120.0 million in milestone payments from Astellas due to the approval of EVRENZO® in Europe[199] - Total cash consideration received from collaboration agreements with Astellas and AstraZeneca through September 30, 2021, was $1.28 billion[209] - Total potential cash payments from collaboration agreements amount to $2.54 billion, including upfront and milestone payments[209] - Future milestone payments under license agreements could total approximately $359.1 million, contingent upon achieving specific developmental and regulatory milestones[278] - The company has an exclusive license agreement with Eluminex, which includes an $8.0 million upfront payment and potential future payments of up to $100.0 million[195] Market Position and Sales - Roxadustat had a 33% value share in the erythropoiesis stimulating agents and HIF-PH inhibitors market in China as of October 2021[179] - Falikang became fully operational in January 2021, and it is the primary customer for roxadustat sales in China[282] - Revenue from roxadustat sales is recognized when control is transferred to Falikang, based on estimated transaction price per unit and actual quantity delivered[284] - Direct sales to pharmaceutical distributors in provinces not covered by Falikang also contribute to revenue, with revenue recognized upon transfer of control[289] Financial Risks and Future Outlook - The company anticipates continued losses despite revenue growth from roxadustat product sales in China, and is implementing cost reduction efforts following a Complete Response Letter (CRL) for roxadustat in the U.S.[260] - The company expects substantial additional funding will be needed to support ongoing operations and research and development efforts[260] - The company is subject to risks related to the development and commercialization of novel therapeutics, which may lead to unforeseen expenses and complications[260] - The company has not identified any material changes to its exposure to market risks as of September 30, 2021[295]

FibroGen, Inc. (NASDAQ:FGEN) Q2 2021 Results Conference Call August 9, 2021 5:00 PM ET Company Participants Michael Tung - Vice President of Corporate Strategy and Investor Relations Enrique Conterno - Chief Executive Officer Pat Cotroneo - Chief Financial Officer Mark Eisner - Chief Medical Officer John Hunter - Chief Scientific Officer Thane Wettig - Chief Commercial Officer Chris Chung - Senior Vice President of China Operations Conference Call Participants Michael Yee - Jefferies Annabel Samimy - Stife ...

PART I—FINANCIAL INFORMATION [Item 1. Condensed Consolidated Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20%28Unaudited%29) FibroGen reported a net loss of $205.7 million for the first half of 2021, driven by decreased revenue and increased R&D costs, significantly impacting its cash position [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet reflects a significant decrease in cash and total assets, alongside an increase in total liabilities, impacting stockholders' equity Balance Sheet Items | Balance Sheet Items | June 30, 2021 ($ in thousands) | December 31, 2020 ($ in thousands) | | :--- | :--- | :--- | | Cash and cash equivalents | 353,361 | 678,393 | | Total current assets | 564,466 | 755,110 | | Total assets | 808,618 | 826,840 | | Total current liabilities | 232,764 | 163,187 | | Total liabilities | 528,767 | 385,391 | | Total stockholders' equity | 279,851 | 441,449 | - Cash and cash equivalents decreased significantly by **48%** from **$678.4 million** at year-end 2020 to **$353.4 million** as of June 30, 2021[21](index=21&type=chunk) [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The statements of operations show a widened net loss for Q2 and the first half of 2021, primarily due to decreased revenue and a substantial increase in R&D expenses Statements of Operations Metrics | Metric ($ in thousands, except per share) | Q2 2021 | Q2 2020 | 6 Months 2021 | 6 Months 2020 | | :--- | :--- | :--- | :--- | :--- | | Total Revenue | 24,364 | 42,888 | 62,793 | 67,288 | | R&D Expenses | 122,567 | 61,414 | 197,243 | 116,315 | | SG&A Expenses | 32,554 | 63,535 | 63,334 | 113,138 | | Loss from Operations | (133,835) | (85,137) | (204,263) | (166,212) | | Net Loss | (133,988) | (85,313) | (205,743) | (163,661) | | Net Loss Per Share | (1.45) | (0.95) | (2.24) | (1.84) | - Net loss for Q2 2021 widened to **$134.0 million** from **$85.3 million** in Q2 2020, primarily due to a **43%** decrease in revenue and a **100%** increase in R&D expenses[24](index=24&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash flow statements reveal a significant shift from positive to negative operating cash flow, leading to a substantial net decrease in cash for the first half of 2021 Cash Flow Activities | Cash Flow Activity ($ in thousands) | Six Months Ended June 30, 2021 | Six Months Ended June 30, 2020 | | :--- | :--- | :--- | | Net cash (used in) provided by operating activities | (71,527) | 90,179 | | Net cash (used in) provided by investing activities | (254,252) | 209,864 | | Net cash provided by financing activities | 301 | 3,459 | | Net (decrease) increase in cash | (325,032) | 303,003 | - There was a significant reversal in operating cash flow, from a **$90.2 million** inflow in the first six months of 2020 to a **$71.5 million** outflow in the same period of 2021[35](index=35&type=chunk) [Notes to the Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements) Key notes detail the negative FDA advisory committee recommendation for roxadustat, a new licensing agreement, revenue deferrals, and recent securities class action lawsuits - In July 2021, the FDA's Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted to recommend not approving roxadustat for anemia due to CKD in adult patients[42](index=42&type=chunk) - The company entered into an exclusive license agreement with HiFiBiO Therapeutics in June 2021, making a **$25.0 million** upfront payment which was recorded as a research and development expense[69](index=69&type=chunk)[70](index=70&type=chunk) - Following the negative FDA CRDAC vote, the company revised its estimates of variable consideration and deferred **$11.2 million** in drug product revenue related to commercial supply shipments to AstraZeneca[78](index=78&type=chunk)[104](index=104&type=chunk)[154](index=154&type=chunk) - In April and May 2021, several securities class action complaints were filed against FibroGen and certain officers, alleging materially false and misleading statements regarding Phase 3 clinical data and prospects for FDA approval[149](index=149&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=30&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management attributes the increased net loss in Q2 and H1 2021 to lower revenues, particularly from deferred drug product revenue, and a surge in R&D expenses, while affirming sufficient liquidity for the next 12 months [Business Overview and Recent Developments](index=30&type=section&id=Business%20Overview%20and%20Recent%20Developments) Recent developments include the negative FDA advisory committee vote on roxadustat, its ongoing commercialization in Asia, and pipeline expansion through a new immuno-oncology partnership - A key development was the July 2021 vote by the FDA's CRDAC, which recommended against approving roxadustat for anemia in CKD patients, posing a significant risk to U.S. approval[164](index=164&type=chunk)[183](index=183&type=chunk) - Roxadustat is being commercialized in China, Japan, South Korea, and Chile, with listings in hospitals representing approximately **81%** of the CKD anemia market opportunity in China as of Q2 2021[162](index=162&type=chunk)[179](index=179&type=chunk) - The company expanded its pipeline through a partnership with HiFiBiO Therapeutics, licensing three immuno-oncology programs with a **$25 million** upfront payment and potential for **$1.1 billion** in milestones[196](index=196&type=chunk)[197](index=197&type=chunk) - Pamrevlumab, an antibody targeting CTGF, is in Phase 3 development for idiopathic pulmonary fibrosis (IPF), pancreatic cancer, and Duchenne muscular dystrophy (DMD)[165](index=165&type=chunk) [Results of Operations](index=36&type=section&id=Results%20of%20Operations) Analysis of operations reveals a significant decline in total revenue, primarily due to negative drug product revenue, coupled with a substantial increase in R&D expenses and a decrease in SG&A expenses Revenue by Category | Revenue Category ($ in thousands) | Q2 2021 | Q2 2020 | Change (%) | | :--- | :--- | :--- | :--- | | Development and other revenue | 19,641 | 18,957 | 4% | | Product revenue, net | 13,371 | 15,693 | (15%) | | Drug product revenue | (8,648) | 8,238 | (205%) | | **Total revenue** | **24,364** | **42,888** | **(43%)** | Operating Expenses | Operating Expenses ($ in thousands) | Q2 2021 | Q2 2020 | Change (%) | | :--- | :--- | :--- | :--- | | Cost of goods sold | 3,078 | 3,076 | 0% | | Research and development | 122,567 | 61,414 | 100% | | Selling, general and administrative | 32,554 | 63,535 | (49%) | - The **100%** increase in R&D expenses for Q2 2021 was primarily due to a **$25.0 million** expense for an acquired in-process R&D asset from HiFiBiO, a **$21.7 million** increase in pamrevlumab manufacturing activities, and an **$8.3 million** increase in clinical trial costs[241](index=241&type=chunk) - The **49%** decrease in SG&A expenses for Q2 2021 was mainly driven by a **$34.9 million** reduction in outside service expenses due to a change in the calculation of co-promotion expenses with AstraZeneca in China following the formation of the Falikang joint venture[244](index=244&type=chunk) [Liquidity and Capital Resources](index=43&type=section&id=Liquidity%20and%20Capital%20Resources) The company's liquidity position shows a significant decrease in cash and cash equivalents, with net cash used in operating activities, though management projects sufficient funds for the next 12 months - As of June 30, 2021, the company had **$353.4 million** in cash and cash equivalents, and **$259.7 million** in short- and long-term investments[260](index=260&type=chunk) - Net cash used in operating activities for the first six months of 2021 was **$71.5 million**, a stark contrast to the **$90.2 million** provided by operating activities in the same period of 2020[267](index=267&type=chunk)[268](index=268&type=chunk)[270](index=270&type=chunk) - Management believes that existing cash, investments, and receivables will be sufficient to meet anticipated cash requirements for at least the next 12 months[266](index=266&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=47&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company states that there were no material changes to its exposure to market risks during the three and six months ended June 30, 2021, as compared to the risks disclosed in its 2020 Annual Report on Form 10-K - No material changes to market risk exposure were reported for the period[298](index=298&type=chunk) [Item 4. Controls and Procedures](index=48&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were not effective as of June 30, 2021, due to material weaknesses in risk assessment and revenue recognition controls, with a remediation plan in progress - Management concluded that disclosure controls and procedures were not effective as of June 30, 2021[301](index=301&type=chunk) - The ineffectiveness is due to material weaknesses in the risk assessment process and controls related to drug product revenue recognition, which were first identified as of September 30, 2020[303](index=303&type=chunk) - A remediation plan is underway, which includes a comprehensive annual risk assessment, designing and implementing new controls, and hiring additional accounting and internal audit staff[306](index=306&type=chunk) PART II—OTHER INFORMATION [Item 1. Legal Proceedings](index=50&type=section&id=Item%201.%20Legal%20Proceedings) The company is facing multiple securities class action and shareholder derivative complaints alleging false and misleading statements regarding roxadustat's clinical data and FDA approval prospects, which FibroGen intends to vigorously defend against - Multiple securities class action and shareholder derivative lawsuits were filed against the company in Q2 and Q3 2021[313](index=313&type=chunk)[314](index=314&type=chunk) - The lawsuits allege false and misleading statements about roxadustat's Phase 3 clinical data and its FDA approval prospects, which the company denies[313](index=313&type=chunk)[315](index=315&type=chunk) [Item 1A. Risk Factors](index=50&type=section&id=Item%201A.%20Risk%20Factors) The company highlights significant risks, including substantial dependence on roxadustat and pamrevlumab, the negative FDA advisory committee vote for roxadustat, intense competition, supply chain disruptions, reliance on partners, and ongoing material weaknesses in internal financial controls - The company is substantially dependent on the success of its lead products, roxadustat and pamrevlumab[318](index=318&type=chunk) - A significant risk is the negative vote from the FDA's CRDAC, which is expected to have a major impact on roxadustat's approvability for CKD anemia in the U.S[332](index=332&type=chunk) - The company faces substantial competition from established ESAs and other HIF-PH inhibitors in development from companies like GSK, Bayer, and Akebia[356](index=356&type=chunk)[358](index=358&type=chunk) - Identified material weaknesses in internal control over financial reporting could result in material misstatements if not successfully remediated[453](index=453&type=chunk) [Item 5. Other Information](index=86&type=section&id=Item%205.%20Other%20Information) An internal review confirmed that while roxadustat's cardiovascular safety data was accurate, post-hoc changes to stratification factors were used in analyses designated as "primary" in public disclosures, attributed to data complexity and internal compartmentalization, with responsible individuals no longer employed - An internal review confirmed that while underlying data for roxadustat's cardiovascular safety was accurate, post-hoc changes to stratification factors were used in the analyses designated as "primary" in public disclosures[543](index=543&type=chunk)[544](index=544&type=chunk) - The company attributes the issue to data complexity, unclear analysis plans, and compartmentalized information within the organization[544](index=544&type=chunk) - Individuals directly responsible for the decision to use post-hoc stratification factors in the primary analyses are no longer employed by FibroGen[545](index=545&type=chunk)

FibroGen, Inc. (NASDAQ:FGEN) Q1 2021 Earnings Conference Call May 10, 2021 5:00 PM ET Company Participants Michael Tung - Vice President of Corporate Strategy and Investor Relations Enrique Conterno - Chief Executive Officer Pat Cotroneo - Chief Financial Officer Mark Eisner - Chief Medical Officer Thane Wettig - Chief Commercial Officer Chris Chung - Senior Vice President, China Operations Conference Call Participants Annabel Samimy - Stifel Michael Yee - Jefferies Edwin Zhang - H.C. Wainwright Jason Gerbe ...

[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]