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FibroGen (FGEN)

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

Ticker
FGEN
Exchange
CEO
Enrique Conterno
Employees
Incorporated
Location
Fiscal year end
SEC CIK
Subsidiaries
Beijing Falikang Pharmaceutical Co., Ltd. • FibroGen (China) Medical Technology Development Co., Ltd. • FibroGen China Anemia Holdings, Ltd. • FibroGen Europe • FibroGen International (Cayman) Limited • FibroGen International • Skin Sciences, Inc. ...

FGEN stock data

Analyst ratings and price targets

Last 3 months

Investment data

Data from SEC filings
Securities sold
Number of investors

Calendar

8 Aug 22
9 Aug 22
31 Dec 22
Quarter (USD) Jun 22 Mar 22 Dec 21 Sep 21
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS
Annual (USD) Dec 21 Dec 20 Dec 19 Dec 18
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS
Cash burn rate (est.) Burn method: Change in cash Burn method: Operating income Burn method: FCF (opex + capex)
Last Q Avg 4Q Last Q Avg 4Q Last Q Avg 4Q
Cash on hand (at last report) 167.76M 167.76M 167.76M 167.76M 167.76M 167.76M
Cash burn (monthly) 6.05M 15.47M 26.07M 18.79M 11.02M 4.35M
Cash used (since last report) 8.08M 20.67M 34.85M 25.11M 14.73M 5.82M
Cash remaining 159.68M 147.09M 132.91M 142.64M 153.03M 161.94M
Runway (months of cash) 26.4 9.5 5.1 7.6 13.9 37.2

Beta Read what these cash burn values mean

Date Owner Security Transaction Code Indirect 10b5-1 $Price #Shares $Value #Remaining
6 Jul 22 Conterno Enrique A Common Stock Payment of exercise Dispose F No No 12.4 1,296 16.07K 302,631
22 Jun 22 Thane Wettig Common Stock Payment of exercise Dispose F No No 11.42 655 7.48K 91,294
16 Jun 22 Schoeneck James A Common Stock Grant Acquire A No No 0 15,777 0 20,477
16 Jun 22 Schoeneck James A Stock Option Common Stock Grant Acquire A No No 9 25,684 231.16K 25,684
16 Jun 22 Lema Gerald Common Stock Grant Acquire A No No 0 15,777 0 20,477
16 Jun 22 Lema Gerald Stock Option Common Stock Grant Acquire A No No 9 25,684 231.16K 25,684
16 Jun 22 Blaug Suzanne Common Stock Grant Acquire A No No 0 15,777 0 29,825
16 Jun 22 Blaug Suzanne Stock Option Common Stock Grant Acquire A No No 9 25,684 231.16K 25,684
77.6% owned by funds/institutions
13F holders Current Prev Q Change
Total holders 158 166 -4.8%
Opened positions 22 31 -29.0%
Closed positions 30 28 +7.1%
Increased positions 53 46 +15.2%
Reduced positions 52 58 -10.3%
13F shares Current Prev Q Change
Total value 882.13M 2.94B -70.0%
Total shares 72.44M 71.59M +1.2%
Total puts 209.8K 280.8K -25.3%
Total calls 295.6K 309K -4.3%
Total put/call ratio 0.7 0.9 -21.9%
Largest owners Shares Value Change
Primecap Management 13.32M $160.08M +2.5%
Vanguard 9.35M $112.39M +3.5%
BLK Blackrock 6.66M $80.07M +0.2%
Point72 Asset Management 5.83M $70.1M +56.2%
First Trust Portfolios 5.32M $74.98M 0.0%
STT State Street 4.93M $59.23M +9.3%
First Trust Advisors 3.48M $41.82M -34.6%
FHI Federated Hermes 2.4M $28.8M +84.1%
Schroder Investment Management 1.61M $19.48M +22.3%
Geode Capital Management 1.59M $19.06M -2.5%
Largest transactions Shares Bought/sold Change
Point72 Asset Management 5.83M +2.1M +56.2%
First Trust Advisors 3.48M -1.84M -34.6%
FHI Federated Hermes 2.4M +1.09M +84.1%
Norges Bank 0 -642.5K EXIT
Renaissance Technologies 687.9K +588.8K +594.1%
Farallon Capital Management 364.76K -554.35K -60.3%
Dimensional Fund Advisors 732.18K +491.72K +204.5%
Soleus Capital Management 1.06M -486.14K -31.4%
IVZ Invesco 502.52K +437.44K +672.1%
STT State Street 4.93M +420.83K +9.3%

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.
  • Drug development and obtaining marketing authorization is a very difficult endeavor and we may ultimately be unable to obtain regulatory approval for our various product candidates in one or more jurisdictions and in one or more indications.
  • 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.
  • Our product candidates may not achieve adequate market acceptance among physicians, patients, healthcare payors, and others in the medical community necessary for commercial success.
  • 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.
  • 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 may experience delays or technical problems associated with technology transfer, scale-up, or validation of our biologics manufacturing.
  • 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 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 identified material weaknesses in our internal control over financial reporting as of December 31, 2020, which have been remediated. If we otherwise fail to maintain an effective system of internal control, it may result in material misstatements in our financial statements.
  • 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.
  • Changes in U.S. and China relations, as well as relations with other countries, and/or regulations may adversely impact our business.
  • We have limited experience distributing drugs in China.
  • 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.
  • 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.
  • 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.
  • We may be subject to tax inefficiencies associated with our offshore corporate structure.
  • Changes in China’s economic, governmental, or social conditions could have a material adverse effect on our business.
  • If the Chinese government determines that our corporate structure does not comply with Chinese regulations, or if Chinese regulations change or are interpreted differently in the future, the value of our common stock may decline.
  • 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.
  • Our business could continue to be adversely affected by the ongoing COVID-19 global pandemic.
  • 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.
  • 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.
  • Tariffs imposed by the U.S. and those imposed in response by other countries could have a material adverse effect on our business.
  • We do not plan to pay dividends. Capital appreciation will be your sole possible source of gain, which may never occur.
  • Our business or our share price could be negatively affected as a result of shareholder proposals or actions.
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 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 respective periods. This revenue is generally recognized as deliverables are met and services are performed. License revenues represented 50%, 8% and 69% of total revenues for the years ended December 31, 2021, 2020 and 2019, 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, which commenced in the first quarter of 2021 and is expected to continue through 2028. Other development related services are recognized as revenue over the non-contingent development period based on a proportional performance method. As of December 31, 2021, the estimated future non-contingent development periods range from 30 to 54 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 30%, 46% and 44% of total revenues for the years ended December 31, 2021, 2020 and 2019, respectively.

Content analysis

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H.S. junior Avg
New words: answer, BI, discontinued, EVRENZOTM, exempted, LAPC, Nicoya, output, phosphodiesterase, revisit, surcharge, translation, VAT, wrongdoing
Removed: acid, administered, AG, Chia, Chile, commercialized, CSPA, DaVita, executed, field, folic, hundred, investigating, irinotecan, KGaA, Korea, largest, motion, myelosuppressive, NMPA, novelty, obsolete, open, oxaliplatin, PDUFA, regimen, submitted, symptomatic, visit, weekly