NASDAQ:GILD
Gilead Sciences Inc
- Stock
$
Enjoy the risks on your own risk
This section is a very early development of the NLP based news extraction from SEC 10k filings. What you see might not make sense yet, please bear with us.
2021-02-25
Force Majeure
The use of T cells as a potential treatment for cancer may not be broadly accepted by physicians, hospitals, patients, or the general public.
f894bc8f-69c2-4e1a-acf9-0db3a7396053
02021-02-25
Force Majeure
Veklury (remdesivir) was approved by the U.S. Food and Drug Administration in October 2020.
24261a9c-cc66-4b63-8210-33117ecbc846
02021-02-25
Product Failure Risk
If the FDA does not approve the drug in time, it could be written off as an unapproved product.
dfeda40c-70a2-4303-83c2-48f40b5a7f9f
02021-02-25
New Product Development Risk
GILEAD SCIENCES INC rely on third-party sites to collect patients’ white blood cells, known as apheresis centers.
0a30f950-1c7c-491c-943b-40efe9a82c3b
02021-02-25
Demand Risk
Federal and state budget pressures, as well as the annual grant cycles for federal andState funds, may cause purchasing patterns to not reflect patient demand for Yescarta.
7e4b75e4-e245-445a-994a-69ff100662b8
02021-02-25
New Product Development Risk
GILEAD SCIENCES INC sell and distribute most of its products in the United States exclusively through the wholesale channel.
4078c2d1-426c-487c-bdaa-30da601afd87
02021-02-25
Product Failure Risk
Successful commercialization depends in part on the availability of third-party payer reimbursement for the cost of such products.
0697d508-b53c-4723-8b39-746c65a9b180
02021-02-25
Counter Party Risk
Government authorities and third-party payers are increasingly attempting to limit or regulate the price of medical products and services.
9df33861-8425-4771-a574-d4472af6eb6f
02021-02-25
Business Risk
Changes to the 340B program or the Medicaid program at the federal or state level could have a material adverse effect on the company's business.
3990e6e3-9539-463a-8b76-b938de664f72
02021-02-25
Counter Party Risk
Third parties may illegally distribute and sell counterfeit versions of GIlead SCiENCes Inc's medicines.
d031e386-263f-4954-87b7-901bf32e285b
02021-02-25
Counter Party Risk
Counterfeit medicines pose a serious risk to patient health and safety.
e6f1c191-ff69-4da8-8403-e1a598ce0eab
02021-02-25
Counter Party Risk
GILEADS relies on independent third-party contract research organizations ("CROs") to perform most of its clinical studies.
ec28148e-66ae-462e-bcbe-a1e0013f3310
02021-02-25
New Product Development Risk
Any adverse developments affecting or resulting from GILEAD SCIENCES INC's manufacturing operations may result in shipment delays, inventory shortages, lot failures, product withdrawals or recalls.
61fb39e5-0b87-44c1-988c-904657a4522f
02021-02-25
New Product Development Risk
Manufacturing issues may cause delays in GIL's clinical trials and applications for regulatory approval.
ff6a271a-c487-483e-ba2a-6ff237ba6f38
02021-02-25
Innovation Risk
GILEAD SCIENCES INC's operations depend on compliance with complex FDA and comparable international regulations.
667069a1-de0e-4737-9626-0914cf3bfce7
02021-02-25
Product Failure Risk
Failure to obtain broad approvals on a timely basis or to maintain compliance could delay or halt commercialization of GILE ADES' products.
7a25c76d-1ab9-4ac9-a27b-e6f8e8f80408
02021-02-25
Intellectual Property Risk
GILEAD SCIENCES INC's methodologies for calculations are inherently subjective and may be subject to review and challenge by various government agencies.
3a9dfef0-90e6-41fe-86db-5859093a0dcb
02021-02-25
Compensation and Benefits Risk
There has also been enhanced scrutiny by governments on reimbursement support offerings, clinical education programs and promotional speaker programs.
b281bc0f-3325-4776-accf-39c72e4d925e
02021-02-25
New Product Development Risk
generic manufacturers have sought, and may continue to seek, FDA approval to market generic versions of GILEAD SCIENCES INC's products.
b50ac4b6-cdef-4075-b37e-c43a97e9073d
02021-02-25
Brand Value Risk
Generic versions may lead toMarket share and price erosion.
4d82d1e5-a318-4513-93ad-c9ca027aa353
02021-02-25
Innovation Risk
GIlead SCiENCes INC rely on unpatented trade secrets and improvements, internal know-how and technological innovation.
7c61dac1-e28e-460c-8900-30baf179c960
02021-02-25
Intellectual Property Risk
GILEAD SCIENCES INC are involved in a number of litigation, investigation and other dispute-related matters.
f2442723-643c-40ae-b430-ea35f9416c3d
02021-02-25
Product Liability Risk
The testing, manufacturing, marketing and use of commercial products involve substantial risk of product liability claims.
ec784bd6-9d8a-46f9-acf6-5c38077b4321
02021-02-25
Publicity Risk
to adversely affect certain of GILEADS' clinical trials.
7daf4139-8d14-49a8-a210-04c87573fefa
02021-02-25
Demand Risk
The pandemic has limited patients’ ability or willingness to access and seek care from healthcare providers and initiate new therapies, which has resulted in lower demand for GILEAD SCIENCES INC's products.
6723e9b0-20ca-4e3b-8926-7058385c95f7
02021-02-25
Workplace Safety Risk
On-site employees testing positive for COVID-19 could lead to mandatory quarantines and potential site shutdowns.
52d62ac9-df0a-4d73-b27a-cebe096a622f
02021-02-25
Publicity Risk
GILEADS INC are subject to the U.S. Foreign Corrupt Practices Act and similar worldwide anti-bribery laws.
21f28717-bff2-4418-8564-48ee98058eaf
02021-02-25
Corporate Governance Risk
The company's international operations are heavily regulated and require significant interaction with foreign officials.
54dd53a4-a521-413a-84c3-4ff2d9dfbdbd
02021-02-25
New Product Development Risk
There is uncertainty concerning any changes in the laws and regulations governing the conduct of clinical trials and marketing of medicinal products.
be8ab4e0-a423-4352-9f81-70baa1135075
02021-02-25
Compensation and Benefits Risk
GILEad's insurance may not be sufficient in type or amount to cover the losses that may result from an interruption or breach of its systems.
56b19e7c-eafd-4e5b-ab4b-2ac82773e1f4
02021-02-25
Employment Law Compliance Risk
Changes to U.S. immigration and work authorization laws and regulations could make it more difficult for employees to work in or transfer to GIlead SCiENCes INC.
fd200083-ff17-4bf9-81c0-6fea8d84bff3
02021-02-25
Intellectual Property Risk
GILEAD SCIENCES INC have engaged in, and may in the future engage in,.
8c05dae1-1bf1-42de-9fc2-333196ac5b5b
02021-02-25
Business Risk
such transactions as part of its business strategy.
07f5b3bc-d75b-492c-a968-622c1237aa98
02021-02-25
Compensation and Benefits Risk
Changes in GIlead SCiENCes INC's effective income tax rate could reduce GILEADS' earnings.
4e1bf859-f876-449a-b674-5f49a77f6a5c
02021-02-25
Credit Risk
Additional indebtedness and a lower cash balance could result in a downgrade of GILAD'S credit ratings.
52eacd98-65dc-4c33-a152-5140f60d76f2
02022-02-23
New Product Development Risk
GILEAD SCIENCES, INC. may or may not be able to accurately predict, materially and adversely affect its business and operations.
4ade7612-ac30-42b7-8530-32e398c35199
02022-02-23
Product Liability Risk
Certain of GIlead's products subject the company to additional or heightened risks.
b1591b10-2104-41f8-9079-383c34648165
02022-02-23
Product Failure Risk
A high rate of failure is inherent in the discovery and development of new products.
8fe628d4-33c2-4b1d-afeb-461a7d68b9bb
02022-02-23
Demand Risk
Federal and state budget pressures, as well as the grant cycles for state funds, may cause purchasing patterns to not reflect patient demand.
79dfb047-5c0c-4db8-818d-4b75c08b5f1a
02022-02-23
New Product Development Risk
The launch of commercially successful products is necessary to grow GIleadSCIENES's business.
e88aa86c-e481-4183-a80d-a7c1cf15c1f0
02022-02-23
New Product Development Risk
GIlead SCiENCes, Inc. sell and distribute most of its products in the United States exclusively through the wholesale channel.
50bc2d38-a7a1-45e9-aaf2-8e9bec9ee06d
02022-02-23
Product Failure Risk
Successful commercialization depends, in part, on the availability of third-party payer reimbursement for the cost of such products.
f0cea55c-d4c7-43b5-b3a8-aa1847f71099
02022-02-23
Inflation Risk
In the United States, the volume of drug pricing-related bills has dramatically increased in recent years.
21afe251-cfce-4989-a919-0cdb42ca0f10
02022-02-23
Compensation and Benefits Risk
Changes to the 340B program or the Medicaid program at the federal or state level could have a material adverse effect on GILEAD SCIENCES, INC.
a7e62855-48d9-480f-844c-0fb889585c72
02022-02-23
Compensation and Benefits Risk
In the EU, there are barriers to reimbursement in individual countries that could limit the uptake of Yescarta and Tecartus.
4e2aeb2f-f727-4f9c-a4ea-0399a9eea83e
02022-02-23
New Product Development Risk
Prices for GILEAD SCIENCES, INC.'s products are based on local market economics and competition and sometimes differ from country to country.
c715edcc-79b8-4e35-8840-19c1e3de43dc
02022-02-23
Counter Party Risk
Third parties have illegally distributed and sold, and may continue to illegally distribute and sell, illegally diverted and counterfeit versions of Gilead’s medicines.
b88ef0f9-07db-407a-8236-9dc25a20b650
02022-02-23
New Product Development Risk
GIlead SCiENCes, Inc. face numerous risks and uncertainties with its clinical trials that could result in delays or prevent completion of the development and approval of its product candidates.
d011b7a5-0001-4a43-8562-afa00dc12259
02022-02-23
Sales Forecast Risk
The company may be unable to recoup the significant RD and Clinical trial expenses incurred in 2022.
6003e31e-8d96-4cb4-8105-1371ccf8a438
02022-02-23
New Product Development Risk
Manufacturing issues may cause delays in clinical trials and applications for regulatory approval.
dde756ac-d336-4bf1-978a-39b3a55e05f5
02022-02-23
Logistics Risk
Problems with any single suppliers or facilities depend on, including in the event of a disaster.
aef8d1a0-ef86-4b55-b3a9-ef4e3cb4e74d
02022-02-23
Product Liability Risk
A significant portion of the raw materials and intermediates used to manufacture GILEAD SCIENCES, INC.'s antiviral products are supplied by third-party manufacturers and corporate partners outside the United States.
052181a2-8b4c-4271-aa21-3b7e7a2356e3
02022-02-23
New Product Development Risk
Failure to obtain broad approvals on a timely basis or to maintain compliance could delay or halt commercialization of GIleads' products.
11ac0fed-f1a0-4ba3-8b35-268fded9c498
02022-02-23
Product Failure Risk
It is uncertain if any products, once launched, will have a commercially successful existence.
ab420169-0b9e-4047-89b3-14f303c4e54e
02022-02-23
Employment Law Compliance Risk
The health care industry is subject to various federal, state and international laws and regulations.
90166f2e-9967-44be-baa5-e14228a80e4a
02022-02-23
New Product Development Risk
The resulting impact on GILEAD SCIENCES, INC.'s business is uncertain and could be material.
22c2abcb-2d29-4bd9-a880-0a26e7d29286
02022-02-23
Compensation and Benefits Risk
There has also been enhanced scrutiny by governments on reimbursement and other patient support offerings.
8eca8cec-f4fa-4aa3-bed2-02c7ce6954c9
02022-02-23
New Product Development Risk
Generic manufacturers have sought, and may continue to seek, FDA approval to market generic versions of GILEADS' products.
1fcf2538-3efa-475d-8ab4-db79486a0888
02022-02-23
Innovation Risk
GIleads rely on unpatented trade secrets and improvements in internal know-how and technological innovation.
4b40d611-f6b2-4765-9701-ff79cc040ad2
02022-02-23
Liability Risk
For a description of the Company's pending patent litigation, see Note 14.
74760399-f8a7-4571-99a6-f2af02553ab8
02022-02-23
Employer Liability Risk
GIleads is involved in a number of litigation, investigation and other dispute-related matters that require GILEADS to expend substantial internal and financial resources.
5abce5d8-cd65-4d27-9199-db686f41b01d
02022-02-23
Product Liability Risk
The testing, manufacturing, marketing and use of GILade's commercial products involve substantial risk of product liability claims.
a43dc791-978d-4c78-9fc9-8f19757e3fc1
02022-02-23
Workplace Safety Risk
GILeade is monitoring anumber of risks related to COVID-19.
2c0205c1-201c-4b7e-9861-7601657c4f8e
02022-02-23
Innovation Risk
The pandemic has adversely affected and may continue to adversely affect certain of GILEAD SCIENCES, INC.'s clinical trials.
d5cc5cb4-d4d9-4de7-b019-ff86725092de
02022-02-23
Force Majeure
For ongoing trials, clinical trial sites have imposed restrictions on patient visits to limit risks of possible COVID-19 exposure.
b3899745-d23c-4f3a-bdf9-fe504ee64b93
02022-02-23
Mandatory Reporting Risk
There is also a risk that closures at clinical sites may be necessary.
bb125b05-4913-4384-a4e5-4c8cfe22d5e5
02022-02-23
Inflation Risk
The pandemic has also amplified many of the other risks described throughout the "Risk Factors" section of this Annual Report on Form 10-K. Inflation and interest rate fluctuations could also adversely impact the company's financial results.
dffbd76c-ad8d-402e-9604-630e44c50742
02022-02-23
Employment Law Compliance Risk
It is possible that certain practices may be challenged under the U.S. Foreign Corrupt Practices Act.
947a9347-e93c-46c1-9443-4e36e7e51718
02022-02-23
Investment Risk
Institutional and individual investors are increasingly using ESG screening criteria to determine whether Gilead qualifies for inclusion in their investment portfolios.
79312b8e-6f90-4045-996c-b86f868cb704
02022-02-23
Sustainability Risk
Failure to achieve any goal or objective, including with respect to environmental and diversity initiatives, is subject to numerous risks, many of which are outside of GIlead SCiENCes, Inc.'s control.
2e9a64c3-3646-4839-8b2b-c2ee55ba8380
02022-02-23
Information Security Risk
There is a great deal of uncertainty regarding the success of GILEAD SCIENCES, INC. Cybersecurity incidents are increasing in their frequency, sophistication and intensity.
4a4ec1a5-54d2-4850-8b15-4e73afaf4b4a
02022-02-23
Information Security Risk
Significant cybersecurity incidents could give rise to legal liability and regulatory action under data protection and privacy laws.
6b9f3bd2-913a-4954-b67e-9c8759fc1137
02022-02-23
Intellectual Property Risk
There is no assurance that GIlead SCiENCes, Inc. will exercise its option right.
d9215cdc-b28d-4618-b692-171cbd9d3d9d
02022-02-23
Intellectual Property Risk
The products, intellectual property and technologies that are acquired or licensed may not be successful or may require significantly greater resources and investments than anticipated.
811201ff-d592-41ff-865d-f1478aa2c498
02022-02-23
Credit Risk
Additional indebtedness and a lower cash balance could result in a downgrade of GIL's credit ratings.
3f6c442c-2ca3-49a1-9760-60f84d3ddf32
02022-02-23
Intellectual Property Risk
GILEAD SCIENCES, INC. may be adversely affected by the resolution of one or more of these exposures in any reporting period.
11d542a5-aa1b-4065-bbff-b2c3e7e38997
02022-02-23
Tax Risk
There are differing interpretations of tax laws and regulations and, as a result, significant disputes may arise.
20dd8ffc-a751-4b9d-bf23-a5da570691c9
0