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FGEN FibroGen

FibroGen, Inc. is a biopharmaceutical company committed to discovering, developing, and commercializing a pipeline of first-in-class therapeutics. The Company applies its pioneering expertise in hypoxia-inducible factor (HIF) and connective tissue growth factor (CTGF) biology to advance innovative medicines for the treatment of unmet needs. The Company is currently developing and commercializing roxadustat, an oral small molecule inhibitor of HIF prolyl hydroxylase activity, for anemia associated with chronic kidney disease (CKD). Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and for chemotherapy-induced anemia (CIA). Pamrevlumab, an anti-CTGF human monoclonal antibody, is in clinical development for the treatment of locally advanced unresectable pancreatic cancer (LAPC), Duchenne muscular dystrophy (DMD), and idiopathic pulmonary fibrosis (IPF).

Company profile

FGEN stock data

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Investment data

Data from SEC filings
Securities sold
Number of investors

Calendar

10 May 21
17 Jun 21
31 Dec 21
Quarter (USD)
Mar 21 Dec 20 Sep 20 Jun 20
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS
Annual (USD)
Dec 20 Dec 19 Dec 18 Dec 17
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS

Financial data from FibroGen earnings reports.

Cash burn rate (estimated) Burn method: Change in cash Burn method: Operating income/loss Burn method: FCF (opex + capex)
Last Q Avg 4Q Last Q Avg 4Q Last Q Avg 4Q
Cash on hand (at last report) 433.51M 433.51M 433.51M 433.51M 433.51M 433.51M
Cash burn (monthly) 81.63M (positive/no burn) 23.79M 15.15M 14.99M (positive/no burn)
Cash used (since last report) 208.89M n/a 60.89M 38.76M 38.37M n/a
Cash remaining 224.61M n/a 372.62M 394.74M 395.14M n/a
Runway (months of cash) 2.8 n/a 15.7 26.1 26.4 n/a

Beta Read what these cash burn values mean

Date Owner Security Transaction Code Indirect 10b5-1 $Price #Shares $Value #Remaining
7 Jun 21 Chung Christine Common Stock Payment of exercise Dispose F No No 22.9 2,030 46.49K 165,251
7 Jun 21 Cotroneo Pat Common Stock Payment of exercise Dispose F No No 22.9 2,141 49.03K 280,730
26 May 21 Blaug Suzanne Common Stock Grant Aquire A No No 0 4,700 0 14,048
26 May 21 Blaug Suzanne Stock Option Common Stock Grant Aquire A No No 20.86 7,800 162.71K 7,800
26 May 21 Brennan Aoife Common Stock Grant Aquire A No No 0 4,700 0 8,614
26 May 21 Brennan Aoife Stock Option Common Stock Grant Aquire A No No 20.86 7,800 162.71K 7,800
26 May 21 Benjamin Cravatt Common Stock Grant Aquire A No No 0 4,700 0 8,614
26 May 21 Benjamin Cravatt Stock Option Common Stock Grant Aquire A No No 20.86 7,800 162.71K 7,800

Data for the last complete 13F reporting period. To see the most recent changes to ownership, click the ownership history button above.

76.8% owned by funds/institutions
13F holders
Current Prev Q Change
Total holders 195 217 -10.1%
Opened positions 24 33 -27.3%
Closed positions 46 24 +91.7%
Increased positions 61 71 -14.1%
Reduced positions 74 72 +2.8%
13F shares
Current Prev Q Change
Total value 3.98B 3.1B +28.1%
Total shares 70.76M 71.82M -1.5%
Total puts 841.8K 676.2K +24.5%
Total calls 199.4K 1.17M -82.9%
Total put/call ratio 4.2 0.6 +628.8%
Largest owners
Shares Value Change
Primecap Management 11.77M $408.6M +27.6%
Vanguard 7.79M $270.49M +3.0%
BLK Blackrock 7.63M $264.7M -3.4%
FMR 5.72M $198.51M -3.1%
Hillhouse Capital Advisors 3.96M $137.31M 0.0%
JHG Janus Henderson 3.28M $114M -3.4%
STT State Street 3.02M $104.86M -5.1%
BK Bank Of New York Mellon 2.33M $80.94M +30.5%
JPM JPMorgan Chase & Co. 2.18M $75.65M +5.4%
TROW T. Rowe Price 1.9M $65.88M -47.7%
Largest transactions
Shares Bought/sold Change
Primecap Management 11.77M +2.54M +27.6%
TROW T. Rowe Price 1.9M -1.73M -47.7%
Norges Bank 0 -717.6K EXIT
Schroder Investment Management 657.83K +657.83K NEW
Westfield Capital Management 0 -591.46K EXIT
BK Bank Of New York Mellon 2.33M +544.56K +30.5%
Artal 0 -400K EXIT
Voya Investment Management 37.18K -296.71K -88.9%
BLK Blackrock 7.63M -271.55K -3.4%
Vanguard 7.79M +227.91K +3.0%

Financial report summary

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Risks
  • We are substantially dependent on the success of our lead product, roxadustat, and our second compound in development, pamrevlumab.
  • Although regulatory approval has been obtained for roxadustat in China, Japan, and Chile, we may be unable to obtain regulatory approval in other countries, or such approval may be delayed or limited, due to a number of factors, many of which are beyond our control.*
  • Preclinical, Phase 1 and Phase 2 clinical trial results may not be indicative of the results that may be obtained in larger clinical trials.
  • We do not know whether our ongoing or planned clinical trials of roxadustat or pamrevlumab will need to be redesigned based on interim results or if we will be able to achieve sufficient patient enrollment or complete planned clinical trials on schedule.
  • Our product candidates may cause or have attributed to them undesirable side effects or have other properties that delay or prevent their regulatory approval or limit their commercial potential.
  • Clinical trials of our product candidates may not uncover all possible adverse effects that patients may experience.
  • Regulatory authorities will do their own benefit risk analysis and may reach a different conclusion than we or our partners have, and these regulatory authorities may base their approval decision on different analyses, data, and statistical methods than ours.*
  • Even if we are able to obtain regulatory approval of our product candidates, the label we obtain may limit the indicated uses for which our product candidates may be marketed.*
  • We face substantial competition in the discovery, development and commercialization of product candidates.*
  • Our product candidates may not achieve adequate market acceptance among physicians, patients, healthcare payors, and others in the medical community necessary for commercial success.
  • Our business could continue to be adversely affected by the ongoing COVID-19 global pandemic.*
  • If our collaborations were terminated or if Astellas or AstraZeneca were to prioritize other initiatives over their collaborations with us, our ability to successfully develop and commercialize our product candidates would suffer.
  • If our preclinical and clinical trial contractors do not properly perform their agreed upon obligations, we may not be able to obtain or may be delayed in receiving regulatory approvals for our product candidates.
  • We currently rely, and expect to continue to rely, on third parties to conduct many aspects of our product manufacturing and distribution, and these third parties may terminate these agreements or not perform satisfactorily.*
  • Certain components of our products are acquired from single-source suppliers or without long-term supply agreements. The loss of these suppliers, or their failure to supply, would materially and adversely affect our business.
  • If our efforts to protect our proprietary technologies are not adequate, we may not be able to compete effectively in our market.*
  • Our reliance on third parties and agreements with collaboration partners requires us to share our trade secrets, which increases the possibility that a competitor may discover them or that our trade secrets will be misappropriated or disclosed.
  • The laws of some foreign countries do not protect proprietary rights to the same extent as do the laws of the U.S., and we may encounter significant problems in securing and defending our intellectual property rights outside the U.S.
  • Intellectual property rights do not address all potential threats to any competitive advantage we may have.
  • The regulatory approval process is highly uncertain and we may not obtain regulatory approval for our product candidates.
  • Our product candidates could fail to receive regulatory approval from the FDA or other regulatory authorities for many reasons, including:
  • Our current and future relationships with customers, physicians, and third-party payors are subject to healthcare fraud and abuse laws, false claims laws, transparency laws, privacy and security laws, and other regulations. If we are unable to comply with such laws, we could face substantial penalties.
  • We are subject to laws and regulations governing corruption, which will require us to maintain costly compliance programs.*
  • We have identified material weaknesses in our internal control over financial reporting. If we are unable to remediate these, or if we otherwise fail to maintain an effective system of internal control, it may result in material misstatements in our financial statements.
  • The impact of recent U.S. healthcare reform, its potential partial or full repeal, and other changes in the healthcare industry and in healthcare spending is currently unknown, and may adversely affect our business model.*
  • Roxadustat is considered a Class 2 substance on the 2019 World Anti-Doping Agency Prohibited List that could limit sales and increase security and distribution costs for our partners and us.
  • If we fail to comply with environmental, health or safety laws and regulations, we could incur fines, penalties or other costs.
  • We have established operations in China and are seeking approval to commercialize our product candidates outside of the U.S., and a number of risks associated with international operations could materially and adversely affect our business.
  • The pharmaceutical industry in China is highly regulated and such regulations are subject to change.
  • We have limited experience distributing drugs in China.
  • We use our own manufacturing facilities in China to produce roxadustat API and drug product. There are risks inherent to operating commercial manufacturing facilities, and with these being our single source suppliers, we may not be able to continually meet market demand.
  • As a company, we have limited experience in pharmacovigilance, medical affairs, and management of the third-party distribution logistics, and cannot assure you we will be able to meet regulatory requirements or operate in these capacities successfully.
  • Our collaboration partner in China, AstraZeneca, and we may experience difficulties in successfully growing and sustaining sales of roxadustat in China.
  • The retail prices of any product candidates that we develop may be subject to pricing control in China and elsewhere.
  • FibroGen (China) Medical Technology Development Co., Ltd. (“FibroGen Beijing”) would be subject to restrictions on paying dividends or making other payments to us, which may restrict our ability to satisfy our liquidity requirements.*
  • We may be subject to currency exchange rate fluctuations and currency exchange restrictions with respect to our operations in China, which could adversely affect our financial performance.
  • Because FibroGen Beijing’s funds are held in banks that do not provide insurance, the failure of any bank in which FibroGen Beijing deposits its funds could adversely affect our business.
  • We may be subject to tax inefficiencies associated with our offshore corporate structure.
  • Uncertainties with respect to the China legal system could have a material adverse effect on us.
  • Changes in China’s economic, governmental, or social conditions could have a material adverse effect on our business.
  • Our operations in China subject us to various Chinese labor and social insurance laws, and our failure to comply with such laws may materially and adversely affect our business, financial condition and results of operations.
  • We have incurred significant losses since our inception and anticipate that we will continue to incur losses for the foreseeable future and may never achieve or sustain profitability. We may require additional financings in order to fund our operations.*
  • Most of our recent revenue has been earned from collaboration partners for our product candidates under development.
  • Loss of senior management and key personnel could adversely affect our business.
  • If product liability lawsuits are brought against us, we may incur substantial liabilities and may have to limit commercial operations.
  • We depend on sophisticated information technology systems and could face a cyber-attack or other breach of these systems.
  • Our headquarters are located near known earthquake fault zones.
  • The market price of our common stock may be highly volatile, and you may not be able to resell your shares at or above your purchase price.
  • We may engage in acquisitions that could dilute stockholders and harm our business.
  • Provisions in our charter documents and Delaware law may have anti-takeover effects that could discourage an acquisition of us by others, and may prevent attempts by our stockholders to replace or remove our current directors or management.
  • Changes in our tax provision or exposure to additional tax liabilities could adversely affect our earnings and financial condition.*
  • Our certificate of incorporation designates courts located in Delaware as the sole forum for certain proceedings, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
  • We do not plan to pay dividends. Capital appreciation will be your sole possible source of gain, which may never occur.
Management Discussion
  • Our revenue to date has been generated substantially from our collaboration agreements with Astellas and AstraZeneca. In addition, we started roxadustat commercial sales in China in the third quarter of 2019.
  • Under our revenue recognition policy, license revenue includes amounts from upfront, non-refundable license payments and amounts allocated pursuant to the standalone selling price method from other consideration received during the periods. This revenue is generally recognized as deliverables are met and services are performed. License revenues represented 8%, 69% and 11% of total revenues for the years ended December 31, 2020, 2019 and 2018, respectively.
  • Development revenue includes co-development and other development related services. Co-development services are recognized as revenue in the period in which they are billed to our partners, excluding China. For China co-development services, revenue is deferred until we begin to transfer control of the manufactured commercial drug product to AstraZeneca.. Other development related services are recognized as revenue over the non-contingent development period based on a proportional performance method. As of December 31, 2020, the estimated future non-contingent development periods range from 3 to 48 months. Other revenues consist of sales of research and development material and have not been material for any of the periods presented. Development and other revenues represented 46%, 44% and 59% of total revenues for the years ended December 31, 2020, 2019 and 2018, respectively.
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