Incyte
34 named things its latest annual report says its results depend on, each in the company's own words. 14 of them are also named by other companies we've read.
Customers
Specialty pharmacies and wholesalers
earns fromnamed as a riskThe loss of any large specialty pharmacy or wholesaler as part of our distribution network, a significant reduction in sales we make to specialty pharmacies or wholesalers, or any failure to pay for the products we have shipped to them could materially and adversely affect our results of operations and financial condition.Risk factors (Item 1A)
Suppliers
Single-source contract manufacturers
depends onnamed as a riskWe generally have a single source or a limited number of suppliers that are qualified to supply each of the API and finished product of our drug products and our other drug candidates.Business (Item 1)
Partners and platforms
Eli Lilly and Company
earns from · $100.0 millionWe received an upfront payment of $100.0 million in connection with the 2025 amendment, which amendment also restructured the royalty obligations on net sales of baricitinib, certain developmental and regulatory milestones associated with baricitinib, and the marketing and sales support obligations of Lilly.Business (Item 1)
Novartis
earns fromnamed as a riskWe derive a substantial portion of our total revenues from product royalties and milestone payments under our collaboration agreements, with royalties on JAKAVI and OLUMIANT representing most of our product royalty, milestone and contract revenues in each of the three most recently completed fiscal years.Risk factors (Item 1A)
MacroGenics, Inc.
depends onWe are responsible for the sourcing and manufacturing of ZYNYZ together with our collaborator MacroGenics.Risk factors (Item 1A)
Syndax Pharmaceuticals, Inc.
depends onIn September 2021, we entered into a Collaboration and License Agreement with Syndax covering the worldwide development and commercialization of NIKTIMVO (axatilimab-csfr), Syndax’s anti-CSF-1R monoclonal antibody.Business (Item 1)
Xencor, Inc.
depends onUnder these licenses, such as our licenses from ARIAD/Takeda, Enable Injections, MacroGenics, Merus, Xencor and Syndax, we may be required to pay up-front fees, license fees, milestone payments and royalties on sales of future products.Business (Item 1)
Merus N.V.
depends onINCA33890 is a TGFβR2xPD-1 bispecific antibody developed by Incyte using Merus’s licensed bispecific platform to avoid the known toxicity of broad TGFβ pathway blockade by specifically blocking TGFβ signaling in cells co-expressing PD-1.Business (Item 1)
Enable Injections, Inc.
depends onUnder the terms of the agreement, we obtained a worldwide, exclusive license to use the enFuse technology with INCA033989 in ET and MF, with the potential to expand to additional assets and indications.Business (Item 1)
Other companies
JAKAFI (ruxolitinib)
concentrated in · substantial majority of our total revenuesnamed as a riskIn addition, revenues from JAKAFI currently make up the substantial majority of our total revenues, but we expect that revenues from JAKAFI will begin to decline once patent exclusivity expires in 2028.Risk factors (Item 1A)
MorphoSys AG
In February 2024, we entered into a purchase agreement with MorphoSys relating to tafasitamab.Business (Item 1)
Competitors
Apotex, Inc.
competes withnamed as a riskWe have received a notice letter from each of Apotex, Inc., Hikma Pharmaceuticals USA Inc., Sun Pharmaceutical Industries Inc., Granules India Ltd., Dr. Reddy’s Laboratories, Inc., and Eugia Pharma Specialties, Ltd., which we refer to as the Generic Manufacturers, notifying us that each has filed an ANDA requesting approval to market a generic version of JAKAFI that contains a paragraph IV certification purporting to challenge one or more patents covering ruxolitinib composition of matter and its use that expire (with pediatric extension) in June 2028 and patents covering ruxolitinib phosphate and its use that expire (with pediatric extension) in December 2028.Risk factors (Item 1A)
Sun Pharmaceutical Industries Inc.
competes withnamed as a riskWe have received a notice letter from each of Apotex, Inc., Hikma Pharmaceuticals USA Inc., Sun Pharmaceutical Industries Inc., Granules India Ltd., Dr. Reddy’s Laboratories, Inc., and Eugia Pharma Specialties, Ltd., which we refer to as the Generic Manufacturers, notifying us that each has filed an ANDA requesting approval to market a generic version of JAKAFI that contains a paragraph IV certification purporting to challenge one or more patents covering ruxolitinib composition of matter and its use that expire (with pediatric extension) in June 2028 and patents covering ruxolitinib phosphate and its use that expire (with pediatric extension) in December 2028.Risk factors (Item 1A)
Dr. Reddy's Laboratories, Inc.
competes withnamed as a riskWe have received a notice letter from each of Apotex, Inc., Hikma Pharmaceuticals USA Inc., Sun Pharmaceutical Industries Inc., Granules India Ltd., Dr. Reddy’s Laboratories, Inc., and Eugia Pharma Specialties, Ltd., which we refer to as the Generic Manufacturers, notifying us that each has filed an ANDA requesting approval to market a generic version of JAKAFI that contains a paragraph IV certification purporting to challenge one or more patents covering ruxolitinib composition of matter and its use that expire (with pediatric extension) in June 2028 and patents covering ruxolitinib phosphate and its use that expire (with pediatric extension) in December 2028.Risk factors (Item 1A)
Eugia Pharma Specialties, Ltd.
competes withnamed as a riskWe have received a notice letter from each of Apotex, Inc., Hikma Pharmaceuticals USA Inc., Sun Pharmaceutical Industries Inc., Granules India Ltd., Dr. Reddy’s Laboratories, Inc., and Eugia Pharma Specialties, Ltd., which we refer to as the Generic Manufacturers, notifying us that each has filed an ANDA requesting approval to market a generic version of JAKAFI that contains a paragraph IV certification purporting to challenge one or more patents covering ruxolitinib composition of matter and its use that expire (with pediatric extension) in June 2028 and patents covering ruxolitinib phosphate and its use that expire (with pediatric extension) in December 2028.Risk factors (Item 1A)
Padagis Israel Pharmaceuticals Ltd.
competes withnamed as a riskWe have received a notice letter from each of Padagis Israel Pharmaceuticals Ltd., Taro Pharmaceuticals Inc., Zydus Lifesciences Limited and Encube Ethicals Private Limited notifying us that each has filed an ANDA requesting approval to market a generic version of OPZELURA and that contains a paragraph IV certification purporting to challenge one or more patents covering ruxolitinib phosphate cream and its uses that expire in 2031 and 2040.Risk factors (Item 1A)
Taro Pharmaceuticals Inc.
competes withnamed as a riskWe have received a notice letter from each of Padagis Israel Pharmaceuticals Ltd., Taro Pharmaceuticals Inc., Zydus Lifesciences Limited and Encube Ethicals Private Limited notifying us that each has filed an ANDA requesting approval to market a generic version of OPZELURA and that contains a paragraph IV certification purporting to challenge one or more patents covering ruxolitinib phosphate cream and its uses that expire in 2031 and 2040.Risk factors (Item 1A)
Zydus Lifesciences Limited
competes withnamed as a riskWe have received a notice letter from each of Padagis Israel Pharmaceuticals Ltd., Taro Pharmaceuticals Inc., Zydus Lifesciences Limited and Encube Ethicals Private Limited notifying us that each has filed an ANDA requesting approval to market a generic version of OPZELURA and that contains a paragraph IV certification purporting to challenge one or more patents covering ruxolitinib phosphate cream and its uses that expire in 2031 and 2040.Risk factors (Item 1A)
Encube Ethicals Private Limited
competes withnamed as a riskWe have received a notice letter from each of Padagis Israel Pharmaceuticals Ltd., Taro Pharmaceuticals Inc., Zydus Lifesciences Limited and Encube Ethicals Private Limited notifying us that each has filed an ANDA requesting approval to market a generic version of OPZELURA and that contains a paragraph IV certification purporting to challenge one or more patents covering ruxolitinib phosphate cream and its uses that expire in 2031 and 2040.Risk factors (Item 1A)
Places
China
depends onnamed as a riskAs a result, an international trade dispute between China and the United States or any other actions by the Chinese government that would limit or prevent Chinese companies from supplying these materials would adversely affect our ability to manufacture and supply our products to meet market needs and have a material and adverse effect on our operating results.Business (Item 1)
Also named by A, AA, AAOI, AAP, AAPL, AB, ADI, AEHR and 261 more
Wilmington, Delaware
concentrated innamed as a riskThe loss of access to or use of our Wilmington, Delaware facility, either on a temporary or permanent basis, would result in an interruption of our business and, consequently, would adversely affect our overall business.Risk factors (Item 1A)
Yverdon, Switzerland
operates innamed as a riskWe may encounter delays and difficulties in scaling up production at our Swiss facility or in obtaining necessary regulatory approvals and registrations to do so.Risk factors (Item 1A)
Commodities and inputs
Ruxolitinib phosphate API
depends on · 24 months stocknamed as a riskWhile our strategy is to maintain at a minimum 24 months stock of ruxolitinib phosphate API, inclusive of finished product, ruxolitinib phosphate might be used by us either to make JAKAFI or OPZELURA or for ruxolitinib drug candidates in clinical trials.Risk factors (Item 1A)
Regulators
U.S. Food and Drug Administration (FDA)
subject tonamed as a riskIt is possible that future sales of JAKAFI and OPZELURA could be negatively affected as a result of the “boxed” warnings, which could have a material and adverse effect on our business, results of operations and prospects.Risk factors (Item 1A)
Also named by A, ABBV, ABT, AMGN, ARE, ARWR, ATR, AXGN and 112 more
European Medicines Agency (EMA)
subject tonamed as a riskThe EMA could take additional actions in the future that reduce the commercial potential of ICLUSIG.Risk factors (Item 1A)
Centers for Medicare and Medicaid Services (CMS)
subject toIn addition, ruxolitinib phosphate qualifies for the Small Biotech Exception from the Centers for Medicare and Medicaid Services (“CMS”) under the Inflation Reduction Act.Business (Item 1)
Also named by ABBV, CDNA, CHE, DGX, DOC, ENSG, GD, GEHC and 6 more
Laws and programs
OECD Pillar Two global minimum tax
subject to · 15%named as a riskFor example, in December 2022, the EU member states agreed to implement in their domestic tax laws a 15% global minimum tax on the profits of large multinational enterprises with a target effective date for fiscal years beginning on or after December 31, 2023.Risk factors (Item 1A)
Also named by ABNB, ACN, ADI, ADM, ADSK, AKAM, ALB, AMAT and 70 more
Medicaid
subject tonamed as a riskIt is expected that this provision, as implemented by the Centers for Medicare and Medicaid Services (“CMS”) will have the effect of increasing Medicaid rebate liability, particularly in the case of medicines that have experienced price increases at a rate in excess of inflation.Risk factors (Item 1A)
Also named by ABBV, ABT, ARE, ARWR, BAX, BMY, BSX, CHE and 39 more
Inflation Reduction Act of 2022
subject tonamed as a riskThe Inflation Reduction Act includes certain exemptions for small biotech drug manufacturers, including Incyte.Risk factors (Item 1A)
Also named by ABBV, APD, ARE, BKH, DD, DHR, ELV, ENPH and 30 more
340B Drug Pricing Program
subject tonamed as a riskthe increasing number of hospitals and other covered entities that are eligible to participate in the U.S. 340B drug pricing program, which requires drug manufacturers such as our company to sell drugs to those entities at discounted prices in order for those drugs to be covered by Medicaid.Risk factors (Item 1A)
Also named by ABBV, BAX, BIIB, BMY, CAH, COR, CVS, EXEL and 13 more
Medicare Part D
subject tonamed as a riskThe new law also reduced the out-of-pocket prescription drug costs for Medicare Part D beneficiaries, and to help pay for this change in benefit design, the law imposes a new discount program which started in 2025 in which manufacturers pay specified discounts on Medicare Part D utilization of their drugs as a condition of selling such drugs in the Medicare Part D program.Risk factors (Item 1A)
Also named by ABBV, AMGN, BMY, CI, CNC, CVS, ELV, JNJ and 5 more
Hatch-Waxman Act
subject tonamed as a riskThe Hatch-Waxman Act provides significant incentives to generic manufacturers to challenge U.S. patents on successful innovative pharmaceutical products.Risk factors (Item 1A)
Most Favored Nation drug pricing executive order
subject tonamed as a riskFor example, an executive order issued on May 12, 2025, directed the Department of Health and Human Services to establish MFN price targets, and, if progress toward these targets is insufficient, to pursue rulemaking that could require sale of certain products in the U.S. at prices no higher than those in comparable developed nations.Risk factors (Item 1A)
American Rescue Plan Act of 2021
subject tonamed as a riskFor example, the American Rescue Plan Act of 2021 includes a provision that became effective in January 2024 that eliminated the statutory cap on rebates that drug manufacturers pay to Medicaid.Risk factors (Item 1A)