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FGEN FibroGen

FibroGen, Inc. is a biopharmaceutical company, which engages in the discovery, development, and commercialization of novel therapeutics. It focuses on the hypoxia-inducible factor and connective tissue growth factor biology to develop medicines for the treatment of anemia, fibrotic disease, and cancer. The company was founded by Thomas B. Neff on September 29, 1993 and is headquartered in San Francisco, CA.

Company profile

FGEN stock data

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Investment data

Data from SEC filings
Securities sold
Number of investors

Calendar

28 Feb 21
11 Apr 21
31 Dec 21
Quarter (USD)
Dec 20 Sep 20 Jun 20 Mar 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) 678.39M 678.39M 678.39M 678.39M 678.39M 678.39M
Cash burn (monthly) (positive/no burn) (positive/no burn) 19.49M 15.96M 2.41M (positive/no burn)
Cash used (since last report) n/a n/a 66.12M 54.13M 8.17M n/a
Cash remaining n/a n/a 612.28M 624.26M 670.22M n/a
Runway (months of cash) n/a n/a 31.4 39.1 278.2 n/a

Beta Read what these cash burn values mean

Date Owner Security Transaction Code Indirect 10b5-1 $Price #Shares $Value #Remaining
11 Mar 21 Kearns Thomas F JR Common Stock Sell Dispose S No No 35.02 18,000 630.36K 148,164
11 Mar 21 Kearns Thomas F JR Common Stock Option exercise Aquire M No No 3.5 18,000 63K 166,164
11 Mar 21 Kearns Thomas F JR Stock Option Common Stock Option exercise Dispose M No No 3.5 6,000 21K 0
11 Mar 21 Kearns Thomas F JR Stock Option Common Stock Option exercise Dispose M No No 3.5 12,000 42K 0
8 Mar 21 Chung Christine Common Stock Payment of exercise Dispose F No No 33.37 5,679 189.51K 166,597
8 Mar 21 Cotroneo Pat Common Stock Payment of exercise Dispose F No No 33.37 5,657 188.77K 282,187
8 Mar 21 Kouchakji Elias Common Stock Payment of exercise Dispose F No No 33.37 5,221 174.22K 147,346
24 Feb 21 Conterno Enrique A Common Stock Grant Aquire A No No 0 82,000 0 137,273
24 Feb 21 Conterno Enrique A Stock Option Common Stock Grant Aquire A No No 53.01 164,000 8.69M 164,000

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

78.5% owned by funds/institutions
13F holders
Current Prev Q Change
Total holders 217 208 +4.3%
Opened positions 33 36 -8.3%
Closed positions 24 24
Increased positions 71 66 +7.6%
Reduced positions 72 74 -2.7%
13F shares
Current Prev Q Change
Total value 3.1B 2.8B +11.0%
Total shares 71.85M 68.01M +5.6%
Total puts 676.2K 533K +26.9%
Total calls 1.17M 407.4K +186.5%
Total put/call ratio 0.6 1.3 -55.7%
Largest owners
Shares Value Change
Primecap Management 9.23M $342.27M +30.3%
BLK Blackrock 7.9M $292.92M +4.8%
Vanguard 7.56M $280.58M +2.7%
FMR 5.9M $218.89M -10.6%
Hillhouse Capital Advisors 3.96M $146.72M 0.0%
TROW T. Rowe Price 3.63M $134.54M -5.8%
JHG Janus Henderson 3.4M $126.09M +2.7%
STT State Street 3.18M $118.08M +13.6%
JPM JPMorgan Chase & Co. 2.07M $76.72M +7.2%
Farallon Capital Management 1.9M $70.47M +2.7%
Largest transactions
Shares Bought/sold Change
Primecap Management 9.23M +2.14M +30.3%
Norges Bank 717.6K +717.6K NEW
FMR 5.9M -702.23K -10.6%
Vantage Consulting 605.71K +605.71K NEW
STT State Street 3.18M +380.56K +13.6%
BLK Blackrock 7.9M +364.55K +4.8%
Westfield Capital Management 591.46K +358.27K +153.6%
FSZ Fiera Capital 672.7K -349.16K -34.2%
MS Morgan Stanley 389.35K +267.47K +219.4%
First Trust Advisors 1.42M -252.97K -15.1%

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.
  • As a company, we have limited commercialization experience, and the time and resources to develop such experience are significant. If we fail to achieve and sustain commercial success for roxadustat with our collaboration partners, our business would be harmed.
  • 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.
  • The results of the FDA Cardiovascular and Renal Drugs Advisory Committee meeting may affect roxadustat’s approvability or label in CKD anemia.
  • Preclinical, Phase 1 and Phase 2 clinical trial results may not be indicative of the results that may be obtained in larger clinical trials.
  • Clinical trials of our product candidates may not uncover all possible adverse effects that patients may experience.
  • If we or our manufacturers cannot properly manufacture sufficient product, we may experience delays in development, regulatory approval, launch or successful commercialization.
  • 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.
  • No or limited reimbursement or insurance coverage of our approved products, if any, by third-party payors may render our products less attractive to patients and healthcare providers.
  • 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.
  • 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.
  • Intellectual property disputes may be costly, time consuming, and may negatively affect our competitive position.
  • 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 cost of maintaining our patent protection is high and requires continuous review and diligence. We may not be able to effectively maintain our intellectual property position throughout the major markets of the world.
  • 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.
  • Our employees may engage in misconduct or improper activities, which could result in significant liability or harm our reputation.
  • 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.
  • We and our collaboration partner in China, AstraZeneca, 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.
  • Any capital contributions from us to FibroGen Beijing must be approved by the Ministry of Commerce in China, and failure to obtain such approval may materially and adversely affect the liquidity position of FibroGen Beijing.
  • 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.
  • 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.
  • We may encounter difficulties in managing our growth and expanding our operations successfully.
  • 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.
  • Our business and operations would suffer in the event of computer system failures.
  • 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.
  • Our principal stockholders own a significant percentage of our stock and will be able to exercise influence over stockholder approvals.
  • We may engage in acquisitions that could dilute stockholders and harm our business.
  • Changes in our tax provision or exposure to additional tax liabilities could adversely affect our earnings and financial condition.
  • Tariffs imposed by the U.S. and those imposed in response by other countries could have a material adverse effect on our business.
  • 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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