Vertex Pharmaceuticals
27 named things its latest annual report says its results depend on, each in the company's own words. 11 of them are also named by other companies we've read.
Customers
Specialty pharmacies and specialty distributors
earns fromWe sell our medicines primarily to a limited number of specialty pharmacy and specialty distributors globally, as well as to certain major wholesalers in the U.S.Business (Item 1)
Suppliers
Lonza
depends onTo further expand our ability to supply clinical and potentially commercial quantities of our cell therapies, we have a strategic agreement with Lonza to support the manufacture of T1D cell therapy product candidates.Business (Item 1)
Partners and platforms
Cystic Fibrosis Foundation
tiered royalties ranging from single digits to sub-teensnamed as a riskPursuant to the CFF Agreement, as amended, we have agreed to pay tiered royalties ranging from single digits to sub-teens on covered compounds first synthesized and/or tested during a research term on or before February 28, 2014, including ivacaftor, lumacaftor and tezacaftor, and royalties ranging from low-single digits to mid-single digits on net sales of certain compounds first synthesized and/or tested between March 1, 2014 and August 31, 2016, including elexacaftor.Business (Item 1)
CRISPR Therapeutics AG
depends on · allocated 60% to us and 40% to CRISPRThe net profits and net losses incurred pursuant to the A&R JDCA with respect to CASGEVY are allocated 60% to us and 40% to CRISPR, subject to certain adjustments, while all other product candidates and products under the A&R JDCA have net profits and net losses shared equally between the parties.Business (Item 1)
Moderna, Inc.
depends onIn 2016, we entered into a collaboration with Moderna for the identification and development of mRNA therapeutics encoding CFTR for the treatment of CF.Business (Item 1)
Also named by MRK
Zai Lab Limited
earns fromZai licensed povetacicept for mainland China, Hong Kong SAR, Macau SAR, Taiwan region, and Singapore, while Ono licensed povetacicept for Japan and South Korea.Business (Item 1)
Ono Pharmaceutical Co., Ltd.
earns fromZai and Ono will help advance povetacicept clinical trials and will be responsible for obtaining marketing authorizations and commercialization activities in the licensed territories, if povetacicept becomes an approved product.Business (Item 1)
Entrada Therapeutics, Inc.
depends onIn 2022, we established a collaboration with Entrada focused on enabling efficient intracellular delivery of an oligonucleotide for DM1.Business (Item 1)
Editas Medicine, Inc.
depends onIn December 2023, we entered into an agreement with Editas Medicine, Inc. (“Editas”), providing us a non-exclusive sublicense to certain patents relating to CRISPR/Cas9 technology, owned by Broad and Harvard, which are licensed to Editas.Business (Item 1)
Other companies
Cystic fibrosis medicines (TRIKAFTA/KAFTRIO, ALYFTREK, SYMDEKO, ORKAMBI, KALYDECO)
concentrated in · Substantially all our net product revenuesnamed as a riskSubstantially all our net product revenues have been derived from the sale of our CF medicines.Risk factors (Item 1A)
ToolGen, Inc.
named as a riskWe and our CASGEVY manufacturing partners are engaged in patent litigation against ToolGen in the U.S., the U.K., and the Netherlands.Business (Item 1)
Places
China
depends onnamed as a riskFor example, we depend on China-based suppliers for portions of our supply chain.Risk factors (Item 1A)
Also named by A, AA, AAOI, AAP, AAPL, AB, ADI, AEHR and 261 more
Russia
named as a riskFor example, we have experienced a violation of our intellectual property rights in Russia, where a copy product that infringes our patents has been made available.Risk factors (Item 1A)
Also named by ALSN, ATR, AVY, AXP, BKR, BSX, C, CDNA and 50 more
Boston, Massachusetts
operates inWe have established our own small molecule manufacturing capabilities in Boston, which we use for clinical trial and commercial supplies, including certain manufacturing steps related to our commercial supply of TRIKAFTA/KAFTRIO.Business (Item 1)
Hazards
Massachusetts coast flooding
concentrated innamed as a riskFor example, our corporate headquarters, as well as additional leased space that we use for certain logistical and laboratory operations and manufacturing, are located in a flood zone along the Massachusetts coast.Risk factors (Item 1A)
Commodities and inputs
Euro
exposed to its price · $6.1 billionnamed as a riskAs a result of our foreign operations, we face significant exposure to movements in foreign currency exchange rates between the U.S. dollar and various foreign currencies, the most significant of which is the Euro.Market risk (Item 7A)
Also named by ABBV, ABNB, ABT, ADBE, ADI, AME, AMG, AMGN and 186 more
Cas9 protein and guide RNA
depends onWe rely on third-party manufacturers to produce or process cell culture reagents and gene-editing components, such as Cas9 protein and guide RNA molecules, for clinical trials and commercial supply of CASGEVY, and to generate gene-edited cells to supply CASGEVY.Business (Item 1)
Regulators
U.S. Food and Drug Administration (FDA)
subject tonamed as a riskFor example, in December 2024, the FDA required us to modify the TRIKAFTA label by revising information regarding liver injury and liver failure and moving that information from the “warnings and precautions” section to a “boxed warning” section; the FDA required similar language in the ALYFTREK label.Risk factors (Item 1A)
Also named by A, ABBV, ABT, AMGN, ARE, ARWR, ATR, AXGN and 112 more
Colorado Prescription Drug Affordability Board
subject tonamed as a riskFor example, in August 2023, the Colorado PDAB selected five drugs for an affordability review, including TRIKAFTA.Risk factors (Item 1A)
Also named by AMGN
Laws and programs
Medicaid
earns from · 21 statesIn addition, 21 states provide coverage via Medicaid.Business (Item 1)
Also named by ABBV, ABT, ARE, ARWR, BAX, BMY, BSX, CHE and 39 more
Inflation Reduction Act (IRA)
subject tonamed as a riskNevertheless, other elements of the IRA may have a material impact on our business, including the redesign of the Part D benefit and the Manufacturer Discount Program, which requires manufacturers to take on more of the beneficiary cost previously subsidized by the federal government through the application of increased drug discounts.Business (Item 1)
Also named by AEE, AMGN, ARWR, BIIB, BKNG, BMY, CAH, CI and 26 more
U.S. legislation restricting Chinese biotechnology companies (BIOSECURE)
subject tonamed as a riskFor example, U.S. legislation has been introduced to limit certain U.S. biotechnology companies from using equipment or services from select Chinese biotechnology companies, and others in Congress have advocated for limitations on those Chinese service providers’ ability to engage in business in the U.S.Risk factors (Item 1A)
CMS GUARD Model
subject tonamed as a riskWhile there is significant uncertainty around the potential implementation of GUARD and related executive orders and rulemaking, implementation of mandatory initiatives could result in reduced pricing and reimbursement for our products.Business (Item 1)
E.U. pharmaceutical legislation reform
subject tonamed as a riskOnce approved, certain provisions of the reform could potentially have an adverse impact on our business.Business (Item 1)
340B Drug Pricing Program
subject toAny company that participates in the Medicaid Drug Rebate Program also must participate in the 340B drug pricing program (the “340B program”), and the Federal Supply Schedule (“FSS”) pricing program.Business (Item 1)
Also named by ABBV, BAX, BIIB, BMY, CAH, COR, CVS, EXEL and 13 more
Medicaid Drug Rebate Program
subject toUnder the Medicaid Drug Rebate program, we are required to pay a rebate to each state Medicaid program for our covered outpatient drugs, which includes select inpatient drugs for which there is “direct reimbursement.”Business (Item 1)
Technology
KALYDECO U.S. basic product patent expiration
2028named as a riskIn some cases, however, such patents may not protect our drug from generic competition after the expiration of the basic patent.Business (Item 1)