Sentences and paragraphs of INCY's Risk Factors and MD&A, 10-K 2026-02-10 against 10-K 2025-02-10.
Each links to the text at sec.gov.
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RewordedRisk Factors
In addition to establishing collaborative or license arrangements under which other parties license our drug candidates for development and commercialization or under which we study our drug candidates in combination with such parties’ compounds or biologics, we may explore opportunities to develop our clinical pipeline by in-licensing drug candidates or therapeutics targets that fit within our focus on oncology, such as our collaborations with Agenus, MacroGenics, Merus (“Merus”) and Syndax Pharmaceuticals, Pharmaceuticals Inc., or explore additional opportunities to further develop and commercialize existing drug candidates in specific jurisdictions, such as our June 2016 acquisition of the development and commercialization rights to ICLUSIG in certain countries.
Read it in 10-K 2026-02-10 at sec.gov ↗
RewordedRisk Factors
Federal Any such disruption or security breach, as well as any action by us or our employees or contractors that might be inconsistent with the rapidly evolving data privacy and security laws and regulations applicable within the United States and elsewhere where we conduct business, could result in enforcement actions by U.S. states, the U.S. federal government or foreign governments, liability or sanctions under data privacy laws, including healthcare laws such as HIPAA, the Health Insurance Portability and Accountability Act, that protect certain types of sensitive information, regulatory penalties, other legal proceedings such as but not limited to private litigation, the incurrence of significant remediation costs, disruptions to our development programs, business operations and collaborations, diversion of management efforts and damage to our reputation, which could harm our business and operations.
Read it in 10-K 2026-02-10 at sec.gov ↗
RewordedRisk Factors
In February 2016, we We have also received a separate notice letter from Apotex, Inc. regarding its filing of an ANDA NDA pursuant to section 505(b)(2) of the FDCA that requested approval to market a generic version rely, in part, on the FDA’s previously published findings of safety and efficacy for JAKAFI and purported that contains a paragraph IV certification purporting to challenge 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.
Read it in 10-K 2026-02-10 at sec.gov ↗
RewordedRisk Factors
Risks related to proposed changes in government regulations and health care reform measures are described below under “—Other Risks Relating to our Business—Health care reform measures could impact the pricing and profitability of pharmaceuticals, and adversely affect the commercial viability of our or our collaborators’ products and drug candidates. ” If government and other third-party payors refuse to provide coverage and reimbursement with respect to our products, determine to provide a lower level of coverage and reimbursement than anticipated, reduce previously approved levels of coverage and reimbursement, or delay reimbursement payments, then our pricing or reimbursement for our products may be affected and our product sales, results of operations or financial condition could be harmed.
Read it in 10-K 2026-02-10 at sec.gov ↗
RewordedRisk Factors
In September 2023, we We have received a notice letter from each of Padagis Israel Pharmaceuticals Ltd. regarding its filing of Ltd., Taro Pharmaceuticals Inc., Zydus Lifesciences Limited and Encube Ethicals Private Limited notifying us that each has filed an ANDA that requested requesting approval to market a generic version of OPZELURA and purported 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.
Read it in 10-K 2026-02-10 at sec.gov ↗
RewordedRisk Factors
In addition to establishing collaborative or license arrangements under which other parties license our drug candidates for development and commercialization or under which we study our drug candidates in combination with such parties’ compounds or biologics, we may explore opportunities to develop our clinical pipeline by in-licensing drug candidates or therapeutics therapeutic targets that fit within our focus on oncology, focus, such as our collaborations with Agenus, MacroGenics, Merus and Syndax Pharmaceuticals, or explore additional opportunities to further develop and commercialize existing drug candidates in specific jurisdictions, such as our June 2016 acquisition of the development and commercialization rights to ICLUSIG in certain countries. Inc.
Read it in 10-K 2026-02-10 at sec.gov ↗
RewordedRisk Factors
In addition, generic versions of imatinib Given ICLUSIG’s various indication statements globally that are available and, while currently focused on resistant or intolerant CML, we currently believe that generic versions of imatinib will not materially impact our commercialization of ICLUSIG, given ICLUSIG’s various indication statements globally that are currently focused on resistant or intolerant CML, ICLUSIG but we cannot be certain how physicians, payors, patients, regulatory authorities and other market participants will respond to the availability of generic versions of imatinib.
Read it in 10-K 2026-02-10 at sec.gov ↗
RewordedRisk Factors
To date, we do not have any drug products that have generated significant revenues other than from sales of JAKAFI and OPZELURA and we We cannot assure you be sure that we will generate substantial revenues from the any drug candidates that we license or develop, including ICLUSIG, PEMAZYRE, MONJUVI/MINJUVI, ZYNYZ and NIKTIMVO develop for several years, if ever.
Read it in 10-K 2026-02-10 at sec.gov ↗
RewordedRisk Factors
Our operations, and those of our CROs, suppliers, and other contractors and consultants, could be subject to geopolitical events, business disruptions as a result of natural disasters, power and other infrastructure failures or shortages, public health pandemics or epidemics, and other natural or man-made disasters or disasters, as well as other business interruptions. uncertainties as a result of international trade policies, including tariff and trade disputes, trade sanctions and import and export licensing requirements.
Read it in 10-K 2026-02-10 at sec.gov ↗
RewordedRisk Factors
We cannot predict the effects on sales of JAKAFI with the updated warnings or OPZELURA as a result of the “boxed” warnings, but it It is possible that future sales of JAKAFI and OPZELURA can could be negatively affected, affected as a result of the “boxed” warnings, which could have a material and adverse effect on our business, results of operations and prospects.
Read it in 10-K 2026-02-10 at sec.gov ↗
RewordedRisk Factors
In addition, the trend toward managed health care healthcare in the United States, the organizations for which could control or significantly influence the purchase of health care services and products, States as well as legislative and regulatory proposals to reform health care healthcare or address the cost of government insurance programs, programs may all result in lower prices for for, or rejection of of, our products.
Read it in 10-K 2026-02-10 at sec.gov ↗
Quiet changesRisk Factors
There can be no assurance that our patents will be upheld or that any litigation in which we might engage with any generic manufacturer would will be successful in protecting exclusivity of our products.
Read it in 10-K 2026-02-10 at sec.gov ↗
Quiet changesRisk Factors
In addition, antitrust scrutiny by regulatory agencies and changes to regulatory approval process processes in the U.S. and foreign jurisdictions may cause approvals to take longer than anticipated to obtain, or may not be obtained at all, or contain burdensome conditions such as required divestitures, which may jeopardize, delay or reduce the anticipated benefits of acquisitions to us and could impede the execution of our business strategy.
Read it in 10-K 2026-02-10 at sec.gov ↗
Quiet changesRisk Factors
Future revenues from research and development collaborations depend upon the continuation of the collaborations, the achievement of milestones milestones, and any royalties we earn from any future products developed from our research.
Read it in 10-K 2026-02-10 at sec.gov ↗
AddedMD&A
Medicare Part D Rebates: Changes to our Medicare Part D prescription drug coverage reimbursements (“Part D Discount Program”) became effective January 1, 2025 pursuant to the Inflation Reduction Act of 2022. Under the revised Part D Discount Program, manufacturers must give a 10 percent discount on Part D drugs in the initial coverage phase, and a 20 percent discount on Part D drugs in the so-called “catastrophic phase” (the phase after the patient incurs costs above the initial phase out-of-pocket threshold, which is $2,000 beginning in 2025). The Inflation Reduction Act includes certain exemptions for small biotech drug manufacturers, including Incyte. These exemptions apply on a drug-specific basis, and qualifying drugs will be exempt from possible negotiation through 2028 and subject to reduced discounts that will be phased-in over a number of years under the new Part D benefit. In 2025, we saw a reduction in our sales allowances owed under Medicare Part D, due to changes to the Part D Discount Program.
Read it in 10-K 2026-02-10 at sec.gov ↗
AddedMD&A
NIKTIMVO net product revenues for 2025 reflect continued strong uptake of the product following its commercial launch during the first quarter of 2025.
Read it in 10-K 2026-02-10 at sec.gov ↗
AddedMD&A
The increase in ZYNYZ net product revenues from 2024 to 2025 was primarily driven by the approval of the product in squamous cell anal carcinoma in the second quarter of 2025.
Read it in 10-K 2026-02-10 at sec.gov ↗
AddedMD&A
The increase in total royalty revenues from 2024 to 2025 was primarily driven by growth in JAKAVI royalty revenue.
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AddedMD&A
As described further in Note 7 of Notes to the Consolidated Financial Statements, during May 2025, we and Novartis entered into a settlement agreement with respect to litigation initiated by Novartis relating to the duration of royalty payments owed by us to Novartis under our Collaboration and License Agreement. As of March 31, 2025, we had approximately $537.1 million of accrued royalties relating to the dispute with Novartis included in accrued and other current liabilities on our consolidated balance sheet. Under the settlement agreement, we paid Novartis $280.0 million as the settlement of disputed royalties on net sales of JAKAFI in the United States through December 31, 2024, and agreed to reduce by 50% the royalty rate payable by us on future net sales of JAKAFI in the United States beginning January 1, 2025. The reduced royalty paid for the quarter ended March 31, 2025, was approximately $14.9 million. The difference of $242.2 million between the total accrued royalties and the total amount paid by us to Novartis as disclosed above was recorded in contract dispute settlement on our consolidated statement of operations for the year ended December 31, 2025.
Read it in 10-K 2026-02-10 at sec.gov ↗
AddedMD&A
As described further in Note 8 of Notes to the Consolidated Financial Statements, during December 2025, the downtown Wilmington, Delaware properties that we acquired in May 2024 met the criteria to be classified as assets held for sale. As a result of this classification, we recorded an asset impairment charge of $76.3 million on our consolidated statement of operations for the year ended December 31, 2025 relating to the downtown Wilmington properties in order to reflect the properties at the lower of their carrying amount or estimated fair value less cost to sell as of December 31, 2025. The estimated fair value less cost to sell of the properties has been recorded within the Prepaid expenses and other current assets line item on our consolidated balance sheet as of December 31, 2025.
Read it in 10-K 2026-02-10 at sec.gov ↗
AddedMD&A
(Gain) loss on change in fair value of acquisition-related contingent consideration
Read it in 10-K 2026-02-10 at sec.gov ↗
AddedMD&A
2025 2024 (in millions) December 31: Cash, cash equivalents, and marketable securities $3,580.6 $2,158.1 Working capital $3,508.7 $1,597.2 Year ended December 31: Cash provided by (used in): Operating activities $1,413.5 $335.3 Investing activities $(102.6) $157.5 Financing activities $101.0 $(2,021.5) Capital expenditures (included in investing activities above) $(58.9) $(86.3)
Read it in 10-K 2026-02-10 at sec.gov ↗
AddedMD&A
The enactment of the One Big Beautiful Bill Act on July 4, 2025 modified key provisions of the Tax Cuts and Jobs Act of 2017. The legislation introduces multiple elections and features various effective dates, with some provisions effective in 2025 and others in subsequent years. The change related to the expensing of domestic research costs will materially reduce our U.S. tax liabilities in 2025 and 2026. We intend to continue to evaluate the impacts of these provisions for our tax return filing.
Read it in 10-K 2026-02-10 at sec.gov ↗
RemovedMD&A
The increase in MINJUVI/MONJUVI net product revenues for the year ended December 31, 2024 compared to the prior period was driven by the acquisition completed in February 2024, under which we gained exclusive global rights to tafasitamab marketed in the United States as MONJUVI (tafasitamab-cxix). Refer to Note 5 of Notes to the Consolidated Financial Statements for further information related to the acquisition.
Read it in 10-K 2025-02-10 at sec.gov ↗
RemovedMD&A
Under the former collaboration and license agreement with MorphoSys, which was executed in March 2020 and continued through February 5, 2024 as described further in Note 5 of the Notes to the Consolidated Financial Statements, we and MorphoSys were both responsible for the commercialization efforts of tafasitamab in the United States and shared equally the profits and losses from the co-commercialization efforts. For the period from January 1, 2024 through February 5, 2024, our 50% share of the profits for tafasitamab was $1.0 million, as recorded in (profit) and loss sharing under collaboration agreements on the consolidated statement of operations. For the year ended December 31, 2023, our 50% share of the costs for tafasitamab was $2.0 million, as recorded in (profit) and loss sharing under collaboration agreements on the consolidated statement of operations.
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RemovedMD&A
Under the collaboration agreement with Syndax, as described further in Note 7 of the Notes to the Consolidated Financial Statements, we and Syndax are both responsible for the co-commercialization of axatilimab in the United States and share equally in the profits and losses from those efforts. We are the principal in the U.S. axatilimab co-commercialization efforts and will record 100% of all product revenues and associated costs in accordance with our profit sharing from co-commercialization activities accounting policy outlined in Note 1 of the Notes to the Consolidated Financial Statements. For the year ended December 31, 2024, there were no revenues from sales of axatilimab, however, there was $22.4 million of expense incurred in connection with the co-commercialization efforts, 50% of which is recorded as selling, marketing and administrative expense in our consolidated statement of operations.
Read it in 10-K 2025-02-10 at sec.gov ↗
RemovedMD&A
For the Years Ended, December 31, 2024 2023 (in millions) Agenus $ (8.2) $ (18.9) Merus 106.1 45.2 MorphoSys 30.7 22.9 Syndax (11.9) (5.5) Other (0.7) 0.2 Total realized and unrealized gain on equity investments $ 116.0 $ 43.9
Read it in 10-K 2025-02-10 at sec.gov ↗
RemovedMD&A
During the year ended December 31, 2024, we sold all remaining investments in Agenus Inc., Merus and MorphoSys AG as described further in in Note 7 of the Notes to the Consolidated Financial Statements.
Read it in 10-K 2025-02-10 at sec.gov ↗
RemovedMD&A
Due to the full utilization of our research and development and orphan drug tax credit carryforwards generated in prior years, our U.S. tax liabilities continue to reflect the adverse impacts of the mandatory capitalization and amortization of research and development expenses as required under the Tax Cuts and Jobs Act of 2017, which eliminated the immediate expensing of such expenses.
Read it in 10-K 2025-02-10 at sec.gov ↗
RewordedMD&A
During the year ended December 31, 2024, our milestone and contract revenues were derived from a $25.0 million combination of upfront payment payments received during from our third party collaborators for the first quarter of 2024 upon our transfer of functional intellectual property to China Medical Systems Holdings Limited, and we recognized $18.0 million of upfront and milestone payments property, as well as developmental milestones received from two of our collaboration partners during the third quarter of 2024. party collaborators.
Read it in 10-K 2026-02-10 at sec.gov ↗
RewordedMD&A
During 2023, 2025, net cash used in provided by financing activities was $20.0 million, consisting $101.0 million and was primarily of cash paid to ARIAD/Takeda for contingent consideration, offset in part driven by proceeds from the issuance of common stock under our stock plans net of tax withholdings. withholdings, offset in part by excise taxes relating to the June 2024 share repurchase and cash paid to ARIAD/Takeda for contingent consideration.
Read it in 10-K 2026-02-10 at sec.gov ↗
RewordedMD&A
Our portfolio focuses on areas of high unmet medical need and includes compounds in various stages, ranging from preclinical to late-stage development, and commercialized approved products are JAKAFI (ruxolitinib), ICLUSIG (ponatinib), PEMAZYRE (pemigatinib), OPZELURA (ruxolitinib cream), MINJUVI (tafasitamab), MONJUVI (tafasitamab-cxix) and ZYNYZ (retifanlimab-dlwr), as well as NIKTIMVO (axatilimab-csfr), (axatilimab-csfr) which was approved for medical use in the United States in August 2024 and will be is co-commercialized.
Read it in 10-K 2026-02-10 at sec.gov ↗
RewordedMD&A
Our portfolio focuses on areas of high unmet medical need and includes compounds in various stages, ranging from preclinical to late-stage development, development and commercialized products JAKAFI (ruxolitinib), ICLUSIG (ponatinib), PEMAZYRE (pemigatinib), OPZELURA (ruxolitinib cream), MINJUVI (tafasitamab), MONJUVI (tafasitamab-cxix) and ZYNYZ (retifanlimab-dlwr), as well as NIKTIMVO (axatilimab-csfr), which was approved for medical use in the United States in August 2024 and will be co-commercialized. products.
Read it in 10-K 2026-02-10 at sec.gov ↗
RewordedMD&A
For the Year Ended, December 31, 2025 2024 2023 (in millions) JAKAFI revenues, net $ 3,092.5 $ 2,792.1 $ 2,593.7 OPZELURA revenues, net 678.5 508.3 337.9 ICLUSIG revenues, net 134.1 114.3 111.6 PEMAZYRE revenues, net 86.7 81.7 83.6 MINJUVI/MONJUVI revenues, net 144.6 119.3 37.1 NIKTIMVO revenues, net 151.6 — ZYNYZ revenues, net 66.3 3.2 1.3 Total product revenues, net 4,354.3 3,618.9 3,165.2 JAKAVI product royalty revenues 457.7 418.8 367.6 OLUMIANT product royalty revenues 144.6 135.6 136.1 TABRECTA product royalty revenues 26.7 22.7 17.8 PEMAZYRE Other product royalty revenues 7.9 2.2 1.9 Total product royalty revenues 636.9 579.3 523.4 Milestone and contract revenues 150.0 43.0 7.0 Total revenues $ 5,141.2 $ 4,241.2 $ 3,695.6
Read it in 10-K 2026-02-10 at sec.gov ↗
RewordedMD&A
The increase in cost of product revenues from 2023 2024 to 2024 2025 was primarily due to driven by growth in net product revenues, increased royalty expense the NIKTIMVO profit share and increased manufacturing related costs. costs, partially offset by the impact from the reduced royalty rate agreed to as part of the contract dispute settlement with Novartis discussed below.
Read it in 10-K 2026-02-10 at sec.gov ↗
RewordedMD&A
The decrease increase in cash provided by operating activities from 2023 2024 to 2024 2025 was due primarily attributable to the changes in net income as a result of the contract dispute settlement during the second quarter of 2025 and the Escient acquisition during the second quarter of 2024, and changes in working capital.
Read it in 10-K 2026-02-10 at sec.gov ↗
RewordedMD&A
During 2023, 2025, net cash used in investing activities was $207.7 $102.6 million, which represents primarily represented purchases of marketable securities of $456.0 $295.5 million, capital expenditures of $32.5 million, $58.9 million and payments for intangible assets of $15.0 million, and purchases of long term investments of $10.0 $25.0 million, offset in part by the sale and maturity maturities of marketable securities of $305.8 $284.6 million.
Read it in 10-K 2026-02-10 at sec.gov ↗
RewordedMD&A
The loss on change in fair value of the contingent consideration during the years ended December 31, 2025 and 2024 and 2023 was due primarily to updated projections of future net revenues and related royalties of ICLUSIG, including the impacts from fluctuations in foreign currency exchange rates impacting future revenue projections of ICLUSIG rates, and the passage of time.
Read it in 10-K 2026-02-10 at sec.gov ↗
RewordedMD&A
We also establish business relationships with other companies and medical research institutions to acquire evaluate opportunities for acquiring products or rights to products and technologies that are complementary to our business. business from other companies and medical research institutions.
Read it in 10-K 2026-02-10 at sec.gov ↗
RewordedMD&A
For the years ending December 31, 2024 2025 and 2023, 2024, our Black-Scholes assumptions included a weighted-average stock price volatility of 29% in 2025 and 30% in 2024 2024, and 32% in 2023, average expected option life of approximately five years and an estimated annualized forfeiture rate of 5%. years.
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RewordedMD&A
We must develop and commercialize new products to achieve revenue growth and to offset revenue losses from when products lose their the loss of product exclusivity or when of JAKAFI in 2028 and the launch of competing products are launched. products.
Read it in 10-K 2026-02-10 at sec.gov ↗