Incyte (INCY) 10-K risk factor changes: FY2024 vs FY2023
The 2024-12-31 10-K against the 2023-12-31 one, compared heading by heading and sentence by sentence.
Item 1A35 rewritten19 added8 removed575 unchanged
All filing items711 rewritten442 added283 removed2,363 unchanged
Summary
counted, not written
- Item 1A lists 39 risk factor headings: 0 new, 1 reworded and 38 unchanged since FY2023. 0 headings from FY2023 no longer appear.
- Sentence by sentence, 442 added, 283 removed, 711 rewritten and 2,363 unchanged across 14 items that differ.
New Item 1A headings (0)
No risk factor heading in this filing is absent from FY2023.
Removed Item 1A headings (0)
Every FY2023 risk factor heading is still here, word for word or reworded.
Reworded Item 1A headings (1)
- Our marketable securities and
[removed: long term][added: equity] investments are subject to risks that could adversely affect our overall financial position.
A heading is new when no FY2023 heading matches it after ignoring case and punctuation, and reworded when it shares at least 60 percent of its words with one that went away. All current risk factor headings.
Sentences by item
24 items, with every count and a link to each item that changed
| Item | Added | Removed | Rewritten | Unchanged |
|---|---|---|---|---|
| Item 1A. Risk Factors | 19 | 8 | 35 | 575 |
| Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations | 40 | 32 | 87 | 160 |
| Item 7A. Quantitative and Qualitative Disclosures About Market Risk | 0 | 0 | 2 | 2 |
| Item 1. Business | 95 | 91 | 73 | 626 |
| Item 3. Legal Proceedings | 0 | 0 | 0 | 4 |
| Cover and table of contents | 5 | 5 | 38 | 162 |
| Item 1B. Unresolved Staff Comments | 0 | 0 | 0 | 1 |
| Item 1C. Cybersecurity | 0 | 0 | 0 | 26 |
| Item 2. Properties | 2 | 0 | 3 | 3 |
| Item 4. Mine Safety Disclosures | 16 | 14 | 12 | 39 |
| Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities | 0 | 0 | 1 | 1 |
| Item 6. [Reserved] | 0 | 0 | 0 | 0 |
| Item 8. Financial Statements and Supplementary Data | 247 | 126 | 409 | 632 |
| Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure | 0 | 0 | 0 | 1 |
| Item 9A. Controls and Procedures | 1 | 1 | 6 | 28 |
| Item 9B. Other Information | 3 | 0 | 2 | 0 |
| Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections | 0 | 0 | 0 | 2 |
| Item 10. Directors, Executive Officers and Corporate Governance | 3 | 0 | 1 | 17 |
| Item 11. Executive Compensation | 0 | 0 | 0 | 1 |
| Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | 0 | 0 | 0 | 1 |
| Item 13. Certain Relationships and Related Transactions, and Director Independence | 0 | 0 | 0 | 1 |
| Item 14. Principal Accountant Fees and Services | 0 | 0 | 0 | 2 |
| Item 15. Exhibits, Financial Statement Schedules | 11 | 6 | 30 | 41 |
| Item 16. Form 10-K Summary. | 0 | 0 | 12 | 38 |
Underlined words on a shaded ground are new in FY2024; struck-through words were in FY2023. Sentences that are wholly new or wholly gone are labelled rather than marked.
Item 1A. Risk Factors
35 rewritten, 19 added, 8 removed, 575 unchanged
While we also sell our and our licensors’ other approved products ICLUSIG, PEMAZYRE, MONJUVI/MINJUVI, [removed: OPZELURA and] [added: OPZELURA,] ZYNYZ and [added: NIKTIMVO and] our exclusive licensees sell OLUMIANT and TABRECTA, we anticipate that JAKAFI product sales will continue to contribute a significant percentage of our total revenues over the next several years.
The costs of JAKAFI, ICLUSIG, PEMAZYRE, MONJUVI/MINJUVI, [removed: OPZELURA and] [added: OPZELURA,] ZYNYZ [added: and NIKTIMVO] are not insignificant and almost all patients will require some form of third-party coverage to afford their cost.
[added: In this regard,] while we have entered into agreements with a number of PBMs, we are in the process of negotiating agreements with additional PBMs and payor accounts to provide rebates to those entities related to formulary coverage for OPZELURA, and we cannot guarantee that we will be able to agree to or maintain acceptable coverage terms with these PBMs and other third party [removed: payors.][added: payors for OPZELURA or additional products in the future.]
Payors could decide to exclude [removed: OPZELURA] [added: our products] from formulary coverage lists, impose step edits that require patients to try alternative, including generic, treatments before authorizing payment for [removed: OPZELURA,] [added: our products,] limit the types of diagnoses for which coverage will be provided or impose a moratorium on coverage for products while the payor makes a coverage decision.
An inability to maintain adequate formulary positions could increase patient cost-sharing for [removed: OPZELURA] [added: our products] and cause some patients to determine not to use [removed: OPZELURA.][added: our products.]
Any delays or unforeseen difficulties in reimbursement approvals could limit patient access, depress therapy adherence rates, and adversely impact our ability to successfully commercialize [removed: OPZELURA.][added: our products.]
If we are unsuccessful in obtaining and maintaining broad coverage and reimbursement for [removed: OPZELURA,] our [added: products, our] anticipated revenue from and growth prospects for [removed: OPZELURA] [added: our products] could be negatively affected.
The testing of JAKAFI, ICLUSIG, PEMAZYRE, MONJUVI/MINJUVI, [removed: OPZELURA] [added: OPZELURA, ZYNYZ] and [removed: ZYNYZ,] [added: NIKTIMVO,] the manufacturing, marketing and sale of JAKAFI, [removed: PEMAZYRE and] [added: PEMAZYRE,] OPZELURA and [added: NIKTIMVO and] the marketing and sale of ICLUSIG, MONJUVI/MINJUVI and ZYNYZ expose us to product liability and other risks.
Similar results could occur with respect to our commercialization of ICLUSIG, PEMAZYRE, MONJUVI/MINJUVI, [removed: OPZELURA] [added: OPZELURA, ZYNYZ] and [removed: ZYNYZ.][added: NIKTIMVO.]
In February 2016, we received a notice letter [added: from Apotex, Inc.] regarding [added: its filing of] an ANDA that requested approval to market a generic version of JAKAFI and purported to challenge patents covering ruxolitinib phosphate and its use that expire [added: (with pediatric extension)] in [added: December] 2028.
The notice letter does not challenge the ruxolitinib composition of matter patent, which expires [added: (with pediatric extension)] in [removed: December 2027.][added: June 2028.]
[removed: Separately,] [added: With respect to deuterated ruxolitinib,] in January 2018 the Patent Trial and Appeal [removed: Board (PTAB)] [added: Board, or PTAB,] of United States Patent and Trademark Office denied [added: institution of] a petition challenging our patent covering deuterated ruxolitinib [removed: analogs and the PTAB subsequently denied the petitioner’s request for rehearing in May 2018.][added: analogs.]
[removed: Nevertheless,] [added: Although] the [added: PTAB's decision is now final, the] petitioner still has the right separately to challenge the validity of our patent in federal court.
There can be no assurance that our patents will be upheld or that any litigation in which we might engage with any [removed: such] generic manufacturer would be successful in protecting [removed: JAKAFI’s exclusivity.][added: exclusivity of our products.]
The entry of a competitive drug product from another company or a generic version of [removed: JAKAFI] [added: one of our products] could result in a decrease in [removed: JAKAFI] sales [added: of our products] and materially harm our business, operating [removed: results] [added: results,] and financial condition.
Competitors and potential competitors for [removed: PEMAZYRE and] [added: PEMAZYRE,] ZYNYZ [added: and NIKTIMVO] include major pharmaceutical and biotechnology companies, as well as specialty pharmaceutical firms.
[removed: Competitors for OPZELURA include existing over-the-counter topical treatments, prescription topical treatments, including generic versions, such as tacrolimus, pimecrolimus, topical steroids, and EUCRISA (crisaborole) from Pfizer Inc., as well as oral and injectable therapies such as prednisone and other oral steroids, injectable DUPIXENT (dupilimab) from Sanofi and Regeneron Pharmaceuticals, Inc., and oral CIBINQO (abrocitinib) from Pfizer Inc. and RINVOQ (upadacitinib) from AbbVie Inc.] In September 2023, we received a notice letter [added: from Padagis Israel Pharmaceuticals Ltd.] regarding [added: its filing of] an ANDA that requested approval to market a generic version of OPZELURA and purported to challenge patents covering ruxolitinib phosphate cream and its uses that expire in 2031 and 2040.
These reforms may affect future investments in our drug development, should the reforms affect our risk-benefit [removed: analysis of investing in a drug candidate.]
These disputes have led and could in the future lead to litigation or arbitration, which could be costly and divert the efforts of our management and scientific [removed: staff,] [added: staff] and could diminish the expected effectiveness of the collaboration.
For example, in January 2022, we decided to opt-out of the continued development with Merus of MCLA-145, which was the most advanced compound under our collaboration with Merus, and in [removed: September 2022,] [added: 2022 and 2023,] we decided to terminate our [removed: collaboration] [added: collaborations] with Calithera [removed: Biosciences.][added: Biosciences and Syros Pharmaceuticals.]
Conflicts may arise between our collaborators and licensees and us, or our collaborators and licensees may [added: choose to terminate their agreements with us, which may adversely affect our business,” conflicts or other issues may arise with our licensors.]
We do not currently operate manufacturing facilities for most of our clinical or commercial products, including JAKAFI, PEMAZYRE, [removed: ICLUSIG] [added: ICLUSIG, OPZELURA] and [removed: OPZELURA,] [added: NIKTIMVO,] and our drug candidates.
[added: Any increases in the cost of our] drug candidates or drug products, whether through conditions affecting the cost and availability of raw materials, such as inflation, decreases in available manufacturing capacity, or otherwise, would adversely affect our results of operations.
We also may pursue strategic alliances in an effort to leverage our existing infrastructure and industry experience to expand our product offerings or [removed: distribution,] [added: distribution] or make investments in other companies.
To date, we do not have any drug products that have generated significant revenues other than from sales of JAKAFI and OPZELURA and we cannot assure you that we will generate substantial revenues from the drug candidates that we license or develop, including ICLUSIG, PEMAZYRE, [removed: MONJUVI/MINJUVI] [added: MONJUVI/MINJUVI, ZYNYZ] and [removed: ZYNYZ,] [added: NIKTIMVO] for several years, if ever.
Even if we are successful in obtaining regulatory approvals for manufacturing and commercializing drug products in addition to JAKAFI, ICLUSIG, PEMAZYRE, MONJUVI/MINJUVI, [removed: OPZELURA] [added: OPZELURA, ZYNYZ] and [removed: ZYNYZ,] [added: NIKTIMVO] we may incur losses if our drug products do not generate significant revenues.
Our marketable securities and [removed: long term] [added: equity] investments are subject to risks that could adversely affect our overall financial position.
We invest our cash in accordance with an established internal policy and customarily in [removed: short-term instruments,] money market funds, U.S. government backed-funds and Treasury securities, which are investment grade and historically have been highly liquid and carried relatively low risk.
Any loss in value of our [removed: long term] [added: equity] investments could adversely affect our financial position on the consolidated balance sheets and consolidated statements of operations.
Furthermore, the enactment of some or all of the recommendations set forth or that may be forthcoming in the Organization for Economic Co-Operation and [removed: Development (OECD)] [added: Development, or OECD,] project on “Base Erosion and Profit [removed: Shifting” (commonly] [added: Shifting,” commonly] known as BEPS [removed: 2.0)] [added: 2.0,] by tax authorities and economic blocs in the countries in which we operate, could unfavorably impact our effective tax rate.
Although we continue to evaluate and [removed: assess] [added: monitor] the potential impact of [removed: the recent U.S. legislation and] BEPS 2.0 on us, [added: and] the [added: OECD] minimum tax rules [added: do not currently have a material impact on us, these minimum tax rules] could [added: in the future] result in tax increases in both the United States and many foreign jurisdictions where we operate or have a presence.
We [removed: derived] [added: derive] a substantial portion of our [added: total] revenues [removed: for the years ended December 31, 2023 and December 31, 2022] from [removed: JAKAVI and OLUMIANT] product royalties and [removed: from] milestone payments under our collaboration [removed: agreements.][added: agreements, with royalties on JAKAVI and OLUMIANT representing most of our product royalty, milestone and contract revenues for each of the three years ended December 31, 2024.]
Malicious [added: cyber] attacks [removed: by third parties] are [added: growing in frequency and sophistication, including the use] of [removed: ever-increasing sophistication] [added: artificial intelligence,] and can be made by groups and individuals with a wide range of motives, including nation states, organized criminal groups, “hacktivists” and others acting with malicious intent.
[removed: In addition,] [added: Further,] many countries and jurisdictions in which we work globally have enacted and/or are proposing privacy and data protection laws and regulations which govern the collection and use of personal information and these may impose large fines and penalties for noncompliance.
These laws and regulations may also require, as applicable, [removed: that][added: that:]
Furthermore, disruptions at the FDA and other regulatory agencies could prevent those agencies from performing normal business functions on which the operation of our business relies, which could negatively impact our business.
Subsequently, we received a notice letter in February 2024 from Apotex challenging the patent covering ruxolitinib composition of matter and its use, which expires (with pediatric extension) in June 2028.
In response, in March 2024, we initiated a patent infringement action against Apotex in the U.S. District Court for the District of New Jersey asserting certain FDA Orange Book listed patents.
That action remains pending.
The PTAB subsequently denied the petitioner’s request for rehearing in May 2018.
In July 2024, the FDA approved a deuterated ruxolitinib product owned by Sun Pharmaceutical Industries Ltd. and Sun Pharmaceutical Industries, Inc., collectively referred to as Sun, for the treatment of severe alopecia areata to be commercialized as “Leqselvi (deuruxolitinib)”.
Prior to the regulatory approval of Leqselvi, we sued Sun for infringement of our patent covering deuterated ruxolitinib analogs in the U.S. District Court for the District of New Jersey and sought a preliminary injunction to bar Sun’s launch of Leqselvi during the pendency of the litigation.
On November 1, 2024, the court entered an order granting our preliminary injunction request.
Sun has appealed the court’s preliminary injunction order to the U.S. Court of Appeals for the Federal Circuit.
Both our underlying infringement action and Sun’s appeal of the court’s preliminary injunction order remain pending.
Competitors for OPZELURA include existing over-the-counter topical treatments and prescription topical treatments, as well as oral and injectable therapies, from major pharmaceutical and biotechnology companies, and companies that produce generic version of prescription treatments.
In November 2023, we initiated a patent infringement action against Padagis in the U.S. District Court for the District of New Jersey asserting certain FDA Orange Book listed patents.
That action remains pending.
analysis of investing in a drug candidate.
On January 15, 2025, the OECD released new guidance addressing implementation of the Pillar Two global minimum tax rules, which were effective for us in tax year 2024.
As part of the guidance, the OECD placed limitations on transactions that produce deferred tax assets entered into during the transition period that runs from November 2021 through an entity’s adoption of Pillar Two.
On January 20, 2025, President Trump signed an executive order effectively cancelling the United States’ commitments to the global minimum tax rules, stating that those commitments cannot have any effect in the United States without an act of approval of the U.S. Congress.
Disruptions or data security breaches within other healthcare companies could also affect our business, results of operations and financial condition.
If systems used by healthcare providers, third-party payors and companies in our distribution network such as PBMs, pharmacies and wholesalers are disrupted by a data security breach, the ability to process claims and fulfill prescriptions could be impacted, which could result in adverse effects on our net product revenues.
In this regard,
With respect to OLUMIANT, in August 2022 we and Lilly received notice letters with respect to ANDAs that requested approval to market generic versions of OLUMIANT prior to the expiration of the three U.S. Patents that expire in 2030.
choose to terminate their agreements with us, which may adversely affect our business,” conflicts or other issues may arise with our licensors.
Any increases in the cost of our
We have engaged CROs to conduct clinical trials outside the United States, including a limited number of trials in Ukraine and Russia.
We may not be able to complete any additional dosing or follow-up visits of patients in Ukraine and Russia who are participating in these clinical trials.
We may also be unable to ship additional clinical drug and other supplies necessary to complete the clinical trials in Ukraine and Russia.
Although the impact of Russia’s invasion is highly unpredictable, certain clinical trial activities have already been changed or suspended, and may continue to be changed, suspended or terminated, which could potentially increase our costs, slow down our product candidate development and approval process and jeopardize our ability to commence product sales and generate revenues.
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations
87 rewritten, 40 added, 32 removed, 160 unchanged
A discussion of our financial performance for the year ended December 31, [removed: 2023] [added: 2024] as compared to the year ended December 31, [removed: 2022] [added: 2023] appears below under the captions “Results of Operations” and “Liquidity and Capital Resources.” A discussion of our financial performance for the year ended December 31, [removed: 2022] [added: 2023] compared to the year ended December 31, [removed: 2021] [added: 2022] can be found under the same captions in Item 7 of our Annual Report on Form 10-K for the year ended December 31, [removed: 2022,] [added: 2023,] filed with the SEC on February [removed: 7, 2023,] [added: 13, 2024,] which is available free of charge on the SEC’s website at *www.sec.gov* and our Investor Relations website at *investor.incyte.com/financial-information/annual-reports*.
Our portfolio focuses on areas of high unmet medical need and includes compounds in various stages, ranging from preclinical to [removed: late stage] [added: late-stage] development, and commercialized products JAKAFI (ruxolitinib), ICLUSIG (ponatinib), PEMAZYRE [removed: (pemigatinib) and] [added: (pemigatinib),] OPZELURA [removed: (ruxolitinib) cream,] [added: (ruxolitinib cream), MINJUVI (tafasitamab), MONJUVI (tafasitamab-cxix) and ZYNYZ (retifanlimab-dlwr),] as well as [removed: MINJUVI (tafasitamab) and MONJUVI (tafasitamab-cxix),] [added: NIKTIMVO (axatilimab-csfr),] which [removed: prior to our February] [added: was approved for medical use in the United States in August] 2024 [removed: acquisition of global rights to tafasitamab, were co-commercialized,] and [removed: ZYNYZ (retifanlimab-dlwr).][added: will be co-commercialized.]
We recognize revenues for product received by our customers net of allowances for customer credits, including estimated rebates, chargebacks, discounts, returns, distribution service fees, patient assistance programs, and government rebates, such as the Medicaid Drug Rebate Program and Medicare Part D coverage gap reimbursements in the United [removed: States.][added: States and mandated discounts in Europe.]
As of December 31, [removed: 2023,] [added: 2024,] a 5% change in our sales allowance and accruals would have had an approximate [removed: $64.3] [added: $79.9] million impact on our income before taxes.
Stock Compensation. Share-based payment transactions with employees, which include stock options, restricted stock units (RSUs) and performance shares (PSUs), are recognized as compensation expense over the requisite service period based on their estimated fair values at the date of grant as well as expected forfeiture rates based on actual [removed: experience.][added: experience, subject to customary retirement provisions that may accelerate the requisite service period for expense recognition purposes.]
The stock compensation process requires [removed: significant judgment and] the use of estimates, particularly surrounding Black-Scholes assumptions such as stock price volatility over the option term and expected option lives, as well as expected forfeiture rates and the probability of PSUs vesting.
For the years ending December 31, [removed: 2023] [added: 2024] and [removed: 2022,] [added: 2023,] our Black-Scholes assumptions included a weighted-average stock price volatility of [removed: 32%] [added: 30%] in [removed: 2023] [added: 2024] and [removed: 36%] [added: 32%] in [removed: 2022,] [added: 2023,] average expected option life of approximately five years and an estimated annualized forfeiture rate of 5%.
The average risk-free interest rate assumption used in the Black-Scholes valuations increased from [removed: 2.14%] [added: 4.01%] in [removed: 2022] [added: 2023] to [removed: 4.01%] [added: 4.15%] in [removed: 2023.][added: 2024.]
[removed: As] [added: Given we do not record] a [removed: result of releasing the] valuation allowance on the majority of our U.S. deferred tax [removed: assets in 2021,] [added: assets,] we expect that our reported income tax expense (current plus deferred) for future periods will be higher than that recorded for prior periods.
Years Ended December 31, [removed: 2023] [added: 2024] and [removed: 2022][added: 2023]
We recorded net income for the years ended December 31, [removed: 2023] [added: 2024] and [removed: 2022] [added: 2023] of [removed: $597.6] [added: $32.6] million and [removed: $340.7] [added: $597.6] million, respectively.
On a per share basis, basic net income was [removed: $1.53] [added: $0.16] and diluted net income was [removed: $1.52] [added: $0.15] for the year ended December 31, [removed: 2022.][added: 2024.]
| JAKAFI revenues, net | | | $ | [removed: 2,593.7] [added: 2,792.1] | | | | | $ | [removed: 2,409.2] [added: 2,593.7] | |
| OPZELURA revenues, net | | | [removed: 337.9] [added: 508.3] | | | | | | [removed: 128.7] [added: 337.9] | | |
| ICLUSIG revenues, net | | | [removed: 111.6] [added: 114.3] | | | | | | [removed: 105.8] [added: 111.6] | | |
| PEMAZYRE revenues, net | | | [removed: 83.6] [added: 81.7] | | | | | | [removed: 83.5] [added: 83.6] | | |
| [removed: MINJUVI] [added: MINJUVI/MONJUVI] revenues, net | | | [removed: 37.1] [added: 119.3] | | | | | | [removed: 19.7] [added: 37.1] | | |
| ZYNYZ revenues, net | | | [removed: 1.3] [added: 3.2] | | | | | | [removed: —] [added: 1.3] | | |
| Total product revenues, net | | | [removed: 3,165.2] [added: 3,618.9] | | | | | | [removed: 2,746.9] [added: 3,165.2] | | |
| JAKAVI product royalty revenues | | | [removed: 367.6] [added: 418.8] | | | | | | [removed: 331.6] [added: 367.6] | | |
| OLUMIANT product royalty revenues | | | [removed: 136.1] [added: 135.6] | | | | | | [removed: 134.5] [added: 136.1] | | |
| TABRECTA product royalty revenues | | | [removed: 17.8] [added: 22.7] | | | | | | [removed: 15.4] [added: 17.8] | | |
| PEMAZYRE product royalty revenues | | | [removed: 1.9] [added: 2.2] | | | | | | [removed: 1.2] [added: 1.9] | | |
| Total product royalty revenues | | | [removed: 523.4] [added: 579.3] | | | | | | [removed: 482.7] [added: 523.4] | | |
| Milestone and contract revenues | | | [removed: 7.0] [added: 43.0] | | | | | | [removed: 165.0] [added: 7.0] | | |
| Total revenues | | | $ | [removed: 3,695.6] [added: 4,241.2] | | | | | $ | [removed: 3,394.6] [added: 3,695.6] | |
The increase in JAKAFI product revenues from [removed: 2022 to] 2023 [added: to 2024] was comprised of a volume increase of [removed: $135.3] [added: $142.3] million and a price increase of [removed: $49.2] [added: $56.1] million.
| Year Ended December 31, [removed: 2023] [added: 2024] | | | | | | Discounts and Distribution Fees | | | | | | Government Rebates and Chargebacks | | | | | | Co-Pay Assistance and Other Discounts | | | | | | Product Returns | | | | | | Total | | |
[removed: Government] [added: U.S. government] rebates and chargebacks are the most significant component of our sales allowances.
Increases in certain [added: U.S.] government reimbursement rates are limited to a measure of inflation, and when the price of a drug increases faster than this measure of inflation it will result in a penalty adjustment factor that causes a larger sales allowance to those government related entities.
As of December 31, [removed: 2023,] [added: 2024,] we have accrued approximately [removed: $59.5] [added: $127.6] million within accrued and other current liabilities on the consolidated balance sheet, relating to the incremental rebates that would be owed were OPZELURA considered a line extension of JAKAFI.
The impact on OPZELURA gross to net deductions for the quarter ending December 31, [removed: 2023,] [added: 2024,] is approximately [removed: 6.5%.][added: 6.3%.]
We expect our sales allowances to fluctuate from quarter to quarter [removed: as a result of the Medicare Part D Coverage Gap,] [added: due to changes in] the volume of purchases eligible for government mandated discounts and rebates as well as changes in discount [removed: percentages] [added: percentages,] which are impacted by potential future price increases, rate of inflation, and other [removed: factors.][added: factors, such as changes to the 340B drug pricing program.]
Our milestone and contract revenues were [removed: $7.0] [added: $43.0] million and [removed: $165.0] [added: $7.0] million for the years ended December 31, [removed: 2023] [added: 2024] and [removed: 2022,] [added: 2023,] respectively.
During the year ended December 31, [removed: 2022,] [added: 2024,] our milestone and contract revenues were derived from [removed: total regulatory milestones achieved of $135.0 million, in addition to] a [removed: $30.0] [added: $25.0] million upfront payment received [added: during the first quarter of 2024] upon our transfer of functional intellectual property to [removed: one] [added: China Medical Systems Holdings Limited, and we recognized $18.0 million] of [added: upfront and milestone payments from two of] our collaboration [removed: partners.][added: partners during the third quarter of 2024.]
| Product costs | | | $ | [removed: 89.2] [added: 129.0] | | | | | $ | [removed: 57.1] [added: 89.2] | |
| Salary and benefits related | | | [removed: 11.9] [added: 16.2] | | | | | | [removed: 9.5] [added: 11.9] | | |
| Stock compensation | | | [removed: 3.1] [added: 2.3] | | | | | | [removed: 2.7] [added: 3.1] | | |
| Royalty expense | | | [removed: 128.2] [added: 141.0] | | | | | | [removed: 116.2] [added: 128.2] | | |
| Amortization of definite-lived intangible assets | | | [removed: 22.6] [added: 23.6] | | | | | | [removed: 21.5] [added: 22.6] | | |
Through the discovery, development and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class and best-in-class medicines for patients and a strong pipeline of products focused in three core therapeutic areas: Oncology, Inflammation & Autoimmunity, and Myeloproliferative Neoplasms (MPNs) & Graft-Versus-Host Disease (GVHD).
| | | | 2024 | | | | | | 2023 | | |
The increase for the year ended December 31, 2024 as compared to the corresponding period in 2023 was primarily driven by an increase in paid demand across all indications.
The increase in OPZELURA net product revenues from 2023 to 2024 was comprised of a volume increase of $165.3 million and a price increase of $5.1 million.
The increase was driven by continued growth in new patient starts and refills, and approximately $60.7 million of OPZELURA net product revenues for 2024 were from Europe.
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).
Product revenues are recorded net of estimated product returns, pricing discounts including rebates offered pursuant to mandatory federal and state government programs and chargebacks, prompt pay discounts and distribution fees and co-pay assistance.
| Balance at January 1, 2024 | | | | | | $ | 20,479 | | | | | $ | 264,422 | | | | | $ | 13,016 | | | | | $ | 11,021 | | | | | $ | 308,938 | |
| Allowances for current period sales | | | | | | 152,167 | | | | | | 1,282,224 | | | | | | 131,979 | | | | | | 23,251 | | | | | | 1,589,621 | | |
| Allowances for prior period sales | | | | | | 429 | | | | | | 2,718 | | | | | | (68) | | | | | | 4,386 | | | | | | 7,465 | | |
| Credits/payments for current period sales | | | | | | (129,777) | | | | | | (1,049,069) | | | | | | (127,400) | | | | | | (238) | | | | | | (1,306,484) | | |
| Credits/payments for prior period sales | | | | | | (15,858) | | | | | | (117,737) | | | | | | (4,237) | | | | | | (15,407) | | | | | | (153,239) | | |
| Balance at December 31, 2024 | | | | | | $ | 27,440 | | | | | $ | 382,558 | | | | | $ | 13,290 | | | | | $ | 23,013 | | | | | $ | 446,301 | |
In 2025, we expect to see a reduction in our sales allowances owed under Medicare Part D, due to changes from the Inflation Reduction Act, which effective January 1, 2025, replaced the manufacturer's coverage gap liability with a different discount structure.
| | | | 2024 | | | | | | 2023 | | |
| | | | 2024 | | | | | | 2023 | | |
| Escient acquisition related compensation expense | | | 11.3 | | | | | | — | | |
| Escient IPR&D expense | | | 679.4 | | | | | | — | | |
Additionally, as described in Note 5 of the Notes to the Consolidated Financial Statements, as part of the Escient acquisition, we recognized compensation expense in research and development of $11.3 million associated with the accelerated vesting for certain Escient stock awards in connection with the acquisition on our consolidated statements of operations.
Research and development expenses for the year ended December 31, 2024 also include the $679.4 million of expense related to the acquired in-process research and development assets as part of the Escient acquisition.
| | | | 2024 | | | | | | 2023 | | |
| Escient acquisition related compensation expense | | | 20.2 | | | | | | — | | |
Additionally, as described in Note 5 of the Notes to the Consolidated Financial Statements, as part of the Escient acquisition, we recognized compensation expense in selling, general and administrative expenses of $20.2 million associated with the accelerated vesting for certain Escient stock awards in connection with the acquisition on our consolidated statements of operations.
*Profit sharing from co-commercialization activities*
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.
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.
Non-operating Income and Expenses
*Realized and unrealized gain (loss) on equity investments*
| | | | 2024 | | | | | | 2023 | | |
| Other | | | (0.7) | | | | | | 0.2 | | |
| Total realized and unrealized gain on equity investments | | | $ | 116.0 | | | | | $ | 43.9 | |
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.
*Provision for income taxes*
Our effective tax rate of 89.7% for the year ended December 31, 2024 increased as compared to 28.4% for the prior year primarily due to non-deductible charges of $710.9 million associated with the Escient acquisition.
Our effective tax rate for 2024 was higher than the U.S. statutory rate primarily due to non-deductible charges of $710.9 million associated with the Escient acquisition.
| | | | 2024 | | | | | | 2023 | | |
*Cash used in financing activities.* During 2024, net cash used in financing activities was $2.0 billion and was primarily driven by expenditures associated with the share repurchase of $2.0 billion.
The June 2024 amendment to the Credit Agreement extended the maturity date of the revolving credit facility from August 2024 to June 2027.
We are focused in two therapeutic areas that are defined by the indications of our approved medicines and the diseases for which our clinical candidates are being developed.
One therapeutic area is Hematology/Oncology, which comprises Myeloproliferative Neoplasms (MPNs), Graft-Versus-Host Disease (GVHD), solid tumors and hematologic malignancies.
The other therapeutic area is Inflammation and Autoimmunity (IAI), which includes our Dermatology commercial franchise.
Regulatory Achievements
In March 2023, under our collaboration agreement with MacroGenics, we received FDA approval of ZYNYZ for the treatment of adults with Merkel cell carcinoma.
In April 2023, the European Commission granted a marketing authorization for OPZELURA(ruxolitinib) cream 15mg/g for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.
In September 2023, under our collaboration agreement with Novartis, we received the regulatory approval of JAKAVI (ruxolitinib) in GVHD by the Japanese Ministry of Health, Labour and Welfare.
In December 2023, the BLA was submitted for axatilimab in chronic graft-versus-host disease for the treatment of patients with chronic GVHD after failure of two or more lines of systemic therapy.
Our product revenues consist of sales of JAKAFI, OPZELURA, ICLUSIG, PEMAZYRE, MINJUVI, and ZYNYZ.
In the fourth quarter of 2021 and fiscal year 2022 for non-covered patients of OPZELURA, we offered a full buy-down program as we were in the process of obtaining commercial insurance coverage for OPZELURA.
During 2022, we contracted with the three largest group purchasing organizations to obtain coverage for OPZELURA.
All full buy-down programs for OPZELURA ended effective January 31, 2023.
During the fourth quarter of 2021 and fiscal year 2022, we also offered a full buy-down program to non-covered patients of OPZELURA as we were obtaining commercial insurance coverage for OPZELURA.
| | | | | | | | | | | | |
| | | | 2023 | | | | | | 2022 | | |
The increase in OPZELURA net product revenues from 2022 to 2023 was driven by growth in patient demand, refills and expansion in payer coverage as the launch in atopic dermatitis and vitiligo continues.
Product revenues are recorded net of sales allowances.
| Balance at January 1, 2023 | | | | | | $ | 25,316 | | | | | $ | 148,465 | | | | | $ | 25,580 | | | | | $ | 6,366 | | | | | $ | 205,727 | |
| Allowances for current period sales | | | | | | 132,062 | | | | | | 994,597 | | | | | | 136,745 | | | | | | 11,986 | | | | | | 1,275,390 | | |
| Allowances for prior period sales | | | | | | (729) | | | | | | 5,338 | | | | | | 3,314 | | | | | | 3,033 | | | | | | 10,956 | | |
| Credits/payments for current period sales | | | | | | (114,055) | | | | | | (811,357) | | | | | | (135,550) | | | | | | — | | | | | | (1,060,962) | | |
| Credits/payments for prior period sales | | | | | | (22,115) | | | | | | (95,108) | | | | | | (17,073) | | | | | | (10,364) | | | | | | (144,660) | | |
| Balance at December 31, 2023 | | | | | | $ | 20,479 | | | | | $ | 241,935 | | | | | $ | 13,016 | | | | | $ | 11,021 | | | | | $ | 286,451 | |
The increase in OLUMIANT product royalty revenues for the year ended December 31, 2023 as compared to the corresponding period in 2022 includes unfavorable changes in foreign currency exchange rates.
The decrease in clinical research and outside services expense from 2022 to 2023 was primarily due to a decrease in one-time collaboration related expenses.
The increase in other contract services and outside costs was primarily due to expenses related to promotional activities to support the launch of OPZELURA for the treatment of vitiligo.
*(Profit) and loss sharing under collaboration agreements*
In February 2024, we entered into a purchase agreement with MorphoSys, as a result of which we now hold exclusive global rights for tafasitamab.
| Calithera | | | (0.2) | | | | | | (0.9) | | |
| Syros | | | 0.4 | | | | | | (2.7) | | |
| Total unrealized gain (loss) on long term investments | | | $ | 43.9 | | | | | $ | (87.6) | |
Our effective tax rate of 28.4% for the year ended December 31, 2023 decreased as compared to 35.6% for the prior year period primarily due to the dilution of the rate impact of foreign losses with no associated tax benefit, an increase in the tax rate benefits associated with research and development and orphan drug tax credits and a decrease in certain non-deductible expenses.
An excerpt. Shown here: 40 of 87 rewritten, all 40 added and all 32 removed. The counts are complete. For every sentence, read Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations in the FY2024 filing and the FY2023 filing.
Item 7A. Quantitative and Qualitative Disclosures About Market Risk
2 rewritten, 0 added, 0 removed, 2 unchanged
As of December 31, [removed: 2023,] [added: 2024,] marketable securities were [removed: $442.7] [added: $470.3] million.
Due to the nature of these investments, if market interest rates were to increase immediately and uniformly by 10% from levels as of December 31, [removed: 2023,] [added: 2024,] the decline in fair value would not be material.
Item 1. Business
73 rewritten, 95 added, 91 removed, 626 unchanged
Our hematology and oncology franchise comprises [removed: five] [added: six] approved products, which are JAKAFI (ruxolitinib), MONJUVI (tafasitamab-cxix)/MINJUVI (tafasitamab), PEMAZYRE (pemigatinib), ICLUSIG [removed: (ponatinib) and] [added: (ponatinib),] ZYNYZ (retifanlimab-dlwr), [added: and NIKTIMVO (axatilimab-csfr),] as well as numerous clinical development programs.
The overall survival information is based on three-year data from COMFORT-I and [removed: II,] [added: II] and shows that at three years the probability of survival for patients treated with JAKAFI in COMFORT-I was 70% and for those patients originally randomized to placebo it was 61%.
In addition, a greater proportion of patients treated with JAKAFI achieved complete hematologic remission—which was defined as achieving hematocrit [removed: control,] [added: control] and lowering platelet and white blood cell counts.
As more fully described in Note [removed: 18] [added: 5] of Notes to the Consolidated Financial Statements, in February 2024, we entered into a purchase agreement with MorphoSys, [removed: the result of which] [added: and as a result,] we now hold exclusive global rights for tafasitamab, and the collaboration and license agreement was terminated.
In August 2020, we and MorphoSys announced that MONJUVI in combination with lenalidomide had been included in the latest [removed: National Comprehensive Cancer Network (NCCN)] [added: NCCN] Clinical Practice Guidelines in Oncology for B-cell Lymphomas.
In October 2017, we and MacroGenics, Inc., announced an exclusive global collaboration and license agreement for MacroGenics’ retifanlimab (formerly INCMGA0012), [removed: an investigational] [added: a humanized] monoclonal antibody [removed: that inhibits PD-1.][added: targeting programmed death receptor-1 (PD-1).]
In March 2023, we announced that the FDA had approved ZYNYZ [removed: (retifanlimab-dlwr), a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1),] [added: (retifanlimab-dlwr)] under accelerated approval, for the treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC).
We are evaluating combinations of ruxolitinib with other therapeutic modalities, as well as developing a once-a-day formulation of ruxolitinib for potential use as monotherapy and [removed: combination therapy.][added: in combinations.]
Phase 2 trials combining ruxolitinib with investigational agents from our portfolio such as INCB57643 (BET) [removed: and INCB00928 (Zilurgisertib)] in patients with MF are [removed: ongoing, and updated] [added: ongoing with] data [added: presented] demonstrating early signals of clinical activity [removed: of both agents] in monotherapy and in combination with [removed: ruxolitinib were presented in June 2023 at the American Society of Clinical Oncology (ASCO) annual meeting and in December 2023 at the American Society of Hematology (ASH) meeting.][added: ruxolitinib.]
Together, we [removed: plan to develop] [added: are developing] axatilimab as a therapy for patients with chronic GVHD where CSF-1R-dependent monocytes and macrophages are believed to contribute to organ fibrosis.
In December 2023, a Biologics License Application (BLA) was submitted to the FDA for axatilimab for the treatment of patients with chronic GVHD after failure of two or more lines of systemic [removed: therapy.][added: therapy and accepted for Priority Review in February 2024.]
[removed: Plans are underway to initiate] [added: We have initiated] two combination trials with axatilimab in cGVHD in [removed: mid-2024,] [added: 2024,] including a randomized Phase 2 combination trial with ruxolitinib and a randomized Phase 3 combination trial with steroids, both directed at treating patients with cGVHD in earlier lines of therapy.
[removed: We currently plan to initiate a] [added: A] Phase 1 study of INCB160058 [added: was initiated] in the [removed: second] [added: first] quarter of 2024.
| Ruxolitinib + [removed: zilurgisertib] [added: INCB57643] (JAK1/JAK2 + [removed: ALK2)] [added: BETi)] | | | Myelofibrosis: Phase 2 | | | | | |
| Ruxolitinib + [removed: axatilimab2] [added: axatilimab1] (JAK1/JAK2 + anti-CSF-1R) | | | Chronic GVHD: Phase [removed: 1/2 in preparation] [added: 2] | | | | | |
| [removed: INCA033989 (mCALR)] [added: INCA33989 (mutCALR)] | | | Myelofibrosis, essential thrombocythemia: Phase 1 | | | | | |
| INCB160058 (JAK2V617Fi) | | | [added: Myelofibrosis:] Phase 1 | | | | | |
| Tafasitamab (MONJUVI/MINJUVI) (CD19) | | | Relapsed or refractory diffuse large B-cell lymphoma (DLBCL): Phase 3 (B-MIND) First-line DLBCL: Phase 3 (*front*MIND) Relapsed or refractory follicular lymphoma [removed: (FL) and relapsed or refractory marginal zone lymphoma (MZL):] [added: (FL):] Phase 3 (*in*MIND) | | | | | |
| Retifanlimab [removed: (ZYNYZ)3] [added: (ZYNYZ)2] (PD-1) | | | [removed: Merkel cell carcinoma (MCC): approved in the U.S.] Squamous cell anal cancer (SCAC): Phase 3 (POD1UM-303) Non-small cell lung cancer (NSCLC): Phase 3 (POD1UM-304) MSI-high endometrial cancer: Phase 2 (POD1UM-101, POD1UM-204) | | | | | |
| INCB123667 (CDK2i) | | | Solid tumors with [removed: Amplification/ Overexpression of CCNE1:] [added: CCNE1 amplification/Cyclin E overexpression:] Phase 1 | | | | | |
| INCB161734 (KRASG12D) | | | Advanced metastatic solid tumors with a [removed: KRAS G12D] [added: KRASG12D] mutation: Phase 1 | | | | | |
[removed: 2.Clinical] [added: 1.Clinical] development of axatilimab in GVHD conducted in collaboration with Syndax Pharmaceuticals.
[removed: 3.Retifanlimab] [added: 2.Retifanlimab] licensed from MacroGenics.
Additional data from this trial is anticipated in [removed: 2024.][added: 2025.]
INCA33890 [removed: (TGFβR2xPD-1)][added: (TGFβR2xPD-1)1]
[removed: Development] [added: 1 In] collaboration with Merus.
[removed: Incyte’s] [added: Our] IAI efforts also include numerous clinical development programs.
Onset can occur at any [removed: age,] [added: age] but is more common in infants and children.
In April 2023, we announced that the European Commission had approved OPZELURA for the topical treatment of nonsegmental vitiligo with facial involvement in adults and adolescents 12 years and older following a positive opinion from the [removed: Committee for Medicinal Products for Human Use (CHMP).][added: CHMP.]
Ruxolitinib cream is a potent, selective inhibitor of JAK1 and JAK2 that provides the opportunity to directly target diverse pathogenic pathways that underlie certain dermatologic conditions, including [removed: atopic dermatitis,] [added: AD,] vitiligo, lichen planus, lichen sclerosus, hidradenitis suppurativa [added: (HS)] and prurigo [removed: nodularis.][added: nodularis (PN).]
In [removed: January,] [added: January] 2024, we announced positive topline results from a randomized controlled Phase 2 study evaluating ruxolitinib cream in [removed: Hidradenitis Suppurativa (HS).][added: HS.]
We also are developing [removed: povorcitinib (formerly INCB54707),] [added: povorcitinib,] which is an oral small molecule selective JAK1 inhibitor.
Povorcitinib is undergoing evaluation in patients with hidradenitis [removed: suppurativa (HS),] [added: suppurativa,] nonsegmental vitiligo, prurigo [removed: nodularis (PN),] [added: nodularis,] asthma and chronic spontaneous urticaria (CSU).
*Prurigo Nodularis.* In October [removed: 2023] [added: 2023,] we announced that the Phase 2, randomized, double-blind, placebo-controlled, dose ranging study evaluating the efficacy and safety of povorcitinib in participants with PN had met its primary endpoint.
| Ruxolitinib cream (OPZELURA)1 (JAK1/JAK2) | | | [removed: AD:] [added: Atopic dermatitis:] Phase 3 pediatric study (TRuE-AD3) [removed: Vitiligo: Approved in the U.S. and Europe Lichen planus: Phase 2 Lichen sclerosus: Phase 2] Hidradenitis suppurativa: Phase 2; Phase 3 [removed: being evaluated] [added: expected to initiate in 2025] Prurigo nodularis: Phase 3 (TRuE-PN1, TRuE-PN2) | | |
| Povorcitinib (JAK1) | | | Hidradenitis suppurativa: Phase 3 (STOP-HS1, STOP-HS2) Vitiligo: Phase 3 (STOP-V1, STOP-V2) Prurigo nodularis: Phase [removed: 2; Phase] 3 [removed: in planning Asthma: Phase 2] [added: (STOP-PN1, STOP-PN2)] Chronic spontaneous urticaria: Phase 2 [added: Asthma: Phase 2] | | |
| INCA034460 [removed: (anti-IL-15Rβ)] [added: (anti-CD122)] | | | Vitiligo: Phase 1 [removed: initiated] | | |
In January 2016, Lilly submitted a New Drug Application (NDA) to the FDA and an MAA to the [removed: EMA] [added: European Medicines Agency (EMA)] for baricitinib as treatment for rheumatoid arthritis.
Dysregulation of the MET pathway triggers tumor growth, formation of new blood vessels that supply the tumor with [removed: nutrients,] [added: nutrients] and causes cancer to spread to other organs.
| Baricitinib (OLUMIANT)2 (JAK1/JAK2) | | | AD: Approved in Europe and Japan Severe alopecia areata (AA): Approved in the U.S., Europe and Japan [added: RA: Approved in the U.S., Europe and Japan] | | |
In December 2024, we submitted a sBLA for tafasitamab in relapsed or refractory follicular lymphoma (FL) to the FDA.
In April 2024, the European Commission approved ZYNYZ (retifanlimab) as monotherapy for the first-line treatment of adult patients with metastatic or recurrent locally advanced MCC not amenable to curative surgery or radiation therapy following a positive opinion from the Committee for Medicinal Products for Human Use (CHMP).
In September 2024, we announced positive results from the Phase 3 POD1UM-303/InterAACT2 trial of ZYNYZ (retifanlimab) in combination with platinum-based chemotherapy (carboplatin–paclitaxel) for the treatment of adults with inoperable locally recurrent or metastatic SCAC.
In December 2024, the supplemental Biologics License Application (sBLA) submission for retifanlimab in advanced/metastatic SCAC was filed with the FDA with approval anticipated in the second half of 2025.
NIKTIMVO (axatilimab-csfr)
In August 2024, we and Syndax announced the FDA approval of NIKTIMVO (axatilimab-csfr) for the treatment of chronic GVHD after failure of at least two prior lines of systemic therapy in adult and pediatric patients.
NIKTIMVO is the first approved anti-CSF-1R antibody targeting the drivers of inflammation and fibrosis seen in chronic GVHD.
In September, we and Syndax announced the New England Journal of Medicine publication of data from the pivotal AGAVE-201 trial of NIKTIMVO in chronic GVHD and the addition of NIKTIMVO to the NCCN Clinical Practice Guidelines in Oncology for the treatment of chronic GVHD.
In January 2025, the FDA approved two smaller vial sizes (9mg and 22mg) of NIKTIMVO to facilitate patient dosing and limit product waste.
The U.S. commercial launch of NIKTIMVO commenced at the end of January 2025.
In December 2024, we announced the full results from the pivotal Phase 3 inMIND trial evaluating treatment with tafasitamab in combination with lenalidomide and rituximab compared with placebo plus lenalidomide and rituximab in patients with relapsed or refractory follicular lymphoma (FL).
The data showed that the study met its primary endpoint by demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) by investigator assessment in 548 patients with FL.
Tafasitamab was generally well-tolerated, and safety was consistent with other CD19 and immunotherapy combination regimens.
In July 2024, we announced positive topline results from both the two Phase 3 clinical studies evaluating retifanlimab, a humanized monoclonal antibody targeting programmed cell death receptor-1 (PD-1), in SCAC and NSCLC.
The phase 3 study in SCAC met its primary endpoint of progression free survival while the Phase 3 study in NSCLC meet its primary endpoint of overall survival.
The safety analysis from both studies showed retifanlimab was generally well-tolerated with no new safety signals observed.
POD1UM-303 is a Phase 3, global, multicenter, randomized, double-blind study evaluating carboplatin-paclitaxel with retifanlimab or placebo in patients with inoperable locally recurrent or metastatic SCAC who have not previously been treated with chemotherapy.
POD1UM-304 is a Phase 3, global, multicenter, randomized, double-blind study evaluating platinum-based chemotherapy with retifanlimab or placebo in patients with first-line, metastatic squamous or nonsquamous NSCLC.
In September 2024, we presented late-breaking Phase 3 results for retifanlimab that were featured during the 2024 European Society for Medical Oncology (ESMO) Presidential Symposium.
The Phase 3 POD1UM-303/InterAACT2 trial for retifanlimab met the primary endpoint of PFS and demonstrated improvement across key secondary endpoints in patients with SCAC receiving retifanlimab in combination with platinum-based chemotherapy (carboplatin-paclitaxel).
| Steroids + axatilimab1 (Steroids + anti-CSF-1R) | | | Chronic GVHD: Phase 3 | | | | | |
| INCA33890 (TGFßR2×PD-1)3 | | | Advanced or metastatic solid tumors: Phase 1 | | | | | |
3.Development collaboration with Merus.
In July 2024, we announced a strategic review of our pipeline with an increased focus on high potential impact programs.
As a result, we discontinued further development of both oral, small molecule PD-L1 inhibitors.
Additionally, we plan to forgo further development of our LAG-3 monoclonal antibody, TIM-3 monoclonal antibody and LAG-3xPD-1 bispecific program.
In September 2024, we presented initial data from the Phase 1 CDK2 inhibitor program at the 2024 ESMO Congress.
Phase 1 data of INCB123667 were presented demonstrating single-agent antitumor activity across a range of doses and regimens, notably in patients with ovarian cancer and endometrial cancer whose tumors overexpress Cyclin E1.
The Phase 1 trial is ongoing with INCB123667 in combination with other agents.
We currently anticipate initiating a pivotal trial in ovarian cancer in 2025.
INCB161734 (KRASG12D)
A Phase 1 study evaluating INCB161734 (KRASG12D) was initiated in the first quarter of 2024.
INCB161734 is a potent, selective and orally bioavailable KRAS G12D inhibitor and, as highlighted at AACR in April 2024, has shown excellent efficacy in several preclinical models.
With no currently approved G12D-targeting agents, INCB161734 could address an important patient need as the KRASG12D mutation is found in 40% of pancreatic ductal adenocarcinoma, 15% of colorectal cancers, and 5% of non-small cell lung cancers.
Data from the ongoing Phase 1 study is expected in 2025.
Data from the ongoing Phase 1 study is expected in 2025.
In October 2024, OPZELURA cream 1.5% was granted a Notice of Compliance by Health Canada for the topical treatment of both mild to moderate atopic dermatitis and nonsegmental vitiligo in patients 12 years of age and older.
A Phase 3 study is expected to initiate in 2025.
In October 2024, we disclosed results from the Phase 2 study of ruxolitinib cream in patients with cutaneous lichen planus.
At this time, we do not plan to advance ruxolitinib cream into a registrational study for lichen planus and plan to publish the results of this study in the future.
We estimate there are between 16,000 and 18,500 patients with MF in the United States.
When phlebotomy can no longer control PV, chemotherapy such as hydroxyurea, or interferon, is utilized.
Approximately 25,000 patients with PV in the United States are considered uncontrolled because they have an inadequate response to or are intolerant of hydroxyurea, the most commonly used chemotherapeutic agent for the treatment of PV.
12-month survival rates in patients with Grade III or IV steroid-refractory acute GVHD are 50% or less, and the incidence of steroid-refractory acute and chronic GVHD is approximately 3,000 per year in the United States.
DLBCL is the most common type of non-Hodgkin lymphoma in adults worldwide, comprising 40% of all cases.
DLBCL is characterized by rapidly growing masses of malignant B-cells in the lymph nodes, spleen, liver, bone marrow or other organs.
It is an aggressive disease with ~40% of patients not responding to initial therapy or relapsing thereafter.
We estimate that there are ~10,000 patients diagnosed in the United States each year with r/r DLBCL who are not eligible for ASCT.
In the EU, we estimate there are ~14,000 patients diagnosed each year with r/r DLBCL who are not eligible for ASCT.
Additional discovery and development initiatives are also ongoing, advancing two Phase 1 studies with INCA33989 (mCALR) and INCB160058 (JAK2V617Fi), both of which hold the potential to be disease modifying therapeutics and address significant unmet need in MF, PV and ET.
Axatilimab
INCA033989 (mCALR)
A placebo-controlled Phase 3 trial (inMIND) of tafasitamab added to lenalidomide plus rituximab (R2) in patients with relapsed or refractory follicular or marginal zone lymphomas is ongoing.
Pemigatinib
Pemigatinib is a potent and selective inhibitor of the fibroblast growth factor receptor (FGFR) isoforms 1, 2 and 3 with demonstrated activity in preclinical studies.
The FGFR family of receptor tyrosine kinases can act as oncogenic drivers in a number of liquid and solid tumor types.
We initiated the FIGHT clinical program to evaluate pemigatinib across a spectrum of cancers that are driven by FGF/FGFR alterations.
The program initially included three Phase 2 trials – FIGHT-201 in patients with bladder cancer, FIGHT-202 in patients with cholangiocarcinoma, and FIGHT-203 in patients with myeloid/lymphoid neoplasms with FGFR1 rearrangement.
Based on data generated from these trials, we have initiated additional trials including FIGHT-302, a Phase 3 study in first-line cholangiocarcinoma.
FIGHT-207, a solid tumor-agnostic trial evaluating pemigatinib in patients with driver-alterations of FGF/FGFR, is now closed to recruitment.
Based on findings from this study, we have identified populations that potentially may benefit from treatment with pemigatinib, and a Phase 2 trial, FIGHT-209, in patients with glioblastoma is ongoing.
Pemigatinib has Breakthrough Therapy designation as a treatment for patients with myeloid/lymphoid neoplasms (MLN) with FGFR1 rearrangement who have relapsed or are refractory to initial chemotherapy.
The Phase 3 POD1UM-303 trial of retifanlimab in combination with platinum-based chemotherapy as a first-line treatment for patients with squamous cell carcinoma of the anal canal (SCAC) is ongoing.
In July 2021, we announced that the FDA issued a complete response letter (CRL) for the BLA of retifanlimab for the treatment of SCAC.
In October 2021, we announced that we withdrew the MAA seeking approval of retifanlimab in SCAC.
The Phase 3 POD1UM-304 trial is evaluating retifanlimab in combination with platinum-based chemotherapy as a first-line treatment for patients with non-small cell lung cancer (NSCLC).
Oral PD-L1
In November 2021, we highlighted Phase 1 clinical safety and efficacy data for our oral PD-L1 program which included two compounds, INCB99280 and INCB99318.
Tumor shrinkage was observed for both oral PD-L1 inhibitors and both were generally well tolerated.
We plan to evaluate INCB99280 in Phase 2 as monotherapy and in combination with other antitumor agents.
Further dose escalation and dose expansion trials are ongoing with INCB99318.
In November 2022, (i) updated safety and preliminary efficacy data for INCB99280 and INCB99318 was presented at the Society for Immunotherapy of Cancer, and (ii) we and Mirati Therapeutics, Inc. announced a clinical trial collaboration and supply agreement to investigate the combination of INCB99280 and adagrasib, a KRASG12C selective inhibitor, in patients with KRASG12C-mutated solid tumors.
In July 2023, we initiated two Phase 1 studies evaluating INCB99280 in combination with axitinib (VEGF) and in combination with ipilimumab (CTLA-4).
A Phase 2 study evaluating INCB99280 in patients with select solid tumors who are checkpoint inhibitor naive also was initiated.
Additionally, we initiated a Phase 2 study evaluating INCB99280 in metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC.
We and Replimune Group, Inc. announced a clinical trial collaboration and supply agreement to investigate the combination of INCB99280 and RP1 in patients with cutaneous squamous cell carcinoma.
RP1 is Replimune’s lead oncolytic immunotherapy product candidate and is based on a proprietary new strain of herpes simplex virus engineered for robust tumor selective replication and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF, intended to maximize tumor killing potency, the immunogenicity of tumor cell death and the activation of a systemic anti-tumor immune response.
| Ruxolitinib + INCB57643 (JAK1/JAK2 + BET) | | | Myelofibrosis: Phase 2 | | | | | |
| Ruxolitinib + CK08041 (JAK1/JAK2 + CB-Tregs) | | | Myelofibrosis: Phase 1 (LIMBER-TREG108) | | | | | |
| Axatilimab (anti-CSF-1R)2 | | | Chronic GVHD: Pivotal Phase 2 (third-line plus therapy) (AGAVE-201); BLA under review in the U.S. | | | | | |
An excerpt. Shown here: 40 of 73 rewritten, 40 of 95 added and 40 of 91 removed. The counts are complete. For every sentence, read Item 1. Business in the FY2024 filing and the FY2023 filing.
Cover and table of contents
38 rewritten, 5 added, 5 removed, 162 unchanged
For the fiscal year ended December 31, [removed: 2023] [added: 2024] or
The aggregate market value of Common Stock held by non-affiliates (based on the closing sale price on The Nasdaq Global Select Market on June [removed: 30, 2023)] [added: 28, 2024)] was approximately [removed: $11.7] [added: $9.9] billion.
As of February [removed: 6, 2024] [added: 3, 2025] there were [removed: 224,526,128] [added: 193,524,350] shares of Common Stock, $.001 par value per share, outstanding.
Items 10 (as to directors and Section 16(a) Beneficial Ownership Reporting Compliance), 11, 12, 13 and 14 of Part III incorporate by reference information from the registrant’s proxy statement to be filed with the Securities and Exchange Commission in connection with the solicitation of proxies for the registrant’s [removed: 2024] [added: 2025] Annual Meeting of Stockholders to be held on June [removed: 12, 2024.][added: 10, 2025.]
| | | | [Forward-Looking [removed: Statements](#ife611127b0c9404b8cdc4fe0d4e43090_10)] [added: Statements](#i188fc563ffb148b9b286ce1260535818_10)] | | | [removed: [2](#ife611127b0c9404b8cdc4fe0d4e43090_10)] [added: [2](#i188fc563ffb148b9b286ce1260535818_10)] | | |
| | | | [Summary Risk [removed: Factors](#ife611127b0c9404b8cdc4fe0d4e43090_13)] [added: Factors](#i188fc563ffb148b9b286ce1260535818_13)] | | | [removed: [5](#ife611127b0c9404b8cdc4fe0d4e43090_13)] [added: [5](#i188fc563ffb148b9b286ce1260535818_13)] | | |
| [Item [removed: 1.](#ife611127b0c9404b8cdc4fe0d4e43090_19)] [added: 1.](#i188fc563ffb148b9b286ce1260535818_19)] | | | [removed: [Business](#ife611127b0c9404b8cdc4fe0d4e43090_19)] [added: [Business](#i188fc563ffb148b9b286ce1260535818_19)] | | | [removed: [6](#ife611127b0c9404b8cdc4fe0d4e43090_19)] [added: [6](#i188fc563ffb148b9b286ce1260535818_19)] | | |
| [Item [removed: 1A.](#ife611127b0c9404b8cdc4fe0d4e43090_49)] [added: 1A.](#i188fc563ffb148b9b286ce1260535818_49)] | | | [Risk [removed: Factors](#ife611127b0c9404b8cdc4fe0d4e43090_49)] [added: Factors](#i188fc563ffb148b9b286ce1260535818_49)] | | | [removed: [36](#ife611127b0c9404b8cdc4fe0d4e43090_49)] [added: [36](#i188fc563ffb148b9b286ce1260535818_49)] | | |
| [Item [removed: 1B.](#ife611127b0c9404b8cdc4fe0d4e43090_52)] [added: 1B.](#i188fc563ffb148b9b286ce1260535818_52)] | | | [Unresolved Staff [removed: Comments](#ife611127b0c9404b8cdc4fe0d4e43090_52)] [added: Comments](#i188fc563ffb148b9b286ce1260535818_52)] | | | [removed: [62](#ife611127b0c9404b8cdc4fe0d4e43090_52)] [added: [64](#i188fc563ffb148b9b286ce1260535818_52)] | | |
| [Item [removed: 1C.](#ife611127b0c9404b8cdc4fe0d4e43090_642)] [added: 1C.](#i188fc563ffb148b9b286ce1260535818_55)] | | | [removed: [Cybersecurity](#ife611127b0c9404b8cdc4fe0d4e43090_642)] [added: [Cybersecurity](#i188fc563ffb148b9b286ce1260535818_55)] | | | [removed: [63](#ife611127b0c9404b8cdc4fe0d4e43090_642)] [added: [64](#i188fc563ffb148b9b286ce1260535818_55)] | | |
| [Item [removed: 2.](#ife611127b0c9404b8cdc4fe0d4e43090_55)] [added: 2.](#i188fc563ffb148b9b286ce1260535818_58)] | | | [removed: [Properties](#ife611127b0c9404b8cdc4fe0d4e43090_55)] [added: [Properties](#i188fc563ffb148b9b286ce1260535818_58)] | | | [removed: [63](#ife611127b0c9404b8cdc4fe0d4e43090_55)] [added: [65](#i188fc563ffb148b9b286ce1260535818_58)] | | |
| [Item [removed: 3.](#ife611127b0c9404b8cdc4fe0d4e43090_58)] [added: 3.](#i188fc563ffb148b9b286ce1260535818_61)] | | | [Legal [removed: Proceedings](#ife611127b0c9404b8cdc4fe0d4e43090_58)] [added: Proceedings](#i188fc563ffb148b9b286ce1260535818_61)] | | | [removed: [64](#ife611127b0c9404b8cdc4fe0d4e43090_58)] [added: [65](#i188fc563ffb148b9b286ce1260535818_61)] | | |
| [Item [removed: 4.](#ife611127b0c9404b8cdc4fe0d4e43090_61)] [added: 4.](#i188fc563ffb148b9b286ce1260535818_64)] | | | [Mine Safety [removed: Disclosures](#ife611127b0c9404b8cdc4fe0d4e43090_61)] [added: Disclosures](#i188fc563ffb148b9b286ce1260535818_64)] | | | [removed: [64](#ife611127b0c9404b8cdc4fe0d4e43090_61)] [added: [65](#i188fc563ffb148b9b286ce1260535818_64)] | | |
| | | | [Information about our Executive [removed: Officers](#ife611127b0c9404b8cdc4fe0d4e43090_64)] [added: Officers](#i188fc563ffb148b9b286ce1260535818_67)] | | | [removed: [64](#ife611127b0c9404b8cdc4fe0d4e43090_64)] [added: [65](#i188fc563ffb148b9b286ce1260535818_67)] | | |
| [Item [removed: 5.](#ife611127b0c9404b8cdc4fe0d4e43090_70)] [added: 5.](#i188fc563ffb148b9b286ce1260535818_73)] | | | [Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity [removed: Securities](#ife611127b0c9404b8cdc4fe0d4e43090_70)] [added: Securities](#i188fc563ffb148b9b286ce1260535818_73)] | | | [removed: [67](#ife611127b0c9404b8cdc4fe0d4e43090_70)] [added: [68](#i188fc563ffb148b9b286ce1260535818_73)] | | |
| [Item [removed: 6.](#ife611127b0c9404b8cdc4fe0d4e43090_73)] [added: 6.](#i188fc563ffb148b9b286ce1260535818_76)] | | | [removed: \[[Reserved](#ife611127b0c9404b8cdc4fe0d4e43090_73)\]] [added: \[[Reserved](#i188fc563ffb148b9b286ce1260535818_76)\]] | | | [removed: [67](#ife611127b0c9404b8cdc4fe0d4e43090_73)] [added: [68](#i188fc563ffb148b9b286ce1260535818_76)] | | |
| [Item [removed: 7.](#ife611127b0c9404b8cdc4fe0d4e43090_76)] [added: 7.](#i188fc563ffb148b9b286ce1260535818_79)] | | | [Management’s Discussion and Analysis of Financial Condition and Results of [removed: Operations](#ife611127b0c9404b8cdc4fe0d4e43090_76)] [added: Operations](#i188fc563ffb148b9b286ce1260535818_79)] | | | [removed: [67](#ife611127b0c9404b8cdc4fe0d4e43090_76)] [added: [68](#i188fc563ffb148b9b286ce1260535818_79)] | | |
| [Item [removed: 7A.](#ife611127b0c9404b8cdc4fe0d4e43090_91)] [added: 7A.](#i188fc563ffb148b9b286ce1260535818_97)] | | | [Quantitative and Qualitative Disclosures About Market [removed: Risk](#ife611127b0c9404b8cdc4fe0d4e43090_91)] [added: Risk](#i188fc563ffb148b9b286ce1260535818_97)] | | | [removed: [76](#ife611127b0c9404b8cdc4fe0d4e43090_91)] [added: [78](#i188fc563ffb148b9b286ce1260535818_97)] | | |
| [Item [removed: 8.](#ife611127b0c9404b8cdc4fe0d4e43090_94)] [added: 8.](#i188fc563ffb148b9b286ce1260535818_100)] | | | [Financial Statements and Supplementary [removed: Data](#ife611127b0c9404b8cdc4fe0d4e43090_94)] [added: Data](#i188fc563ffb148b9b286ce1260535818_100)] | | | [removed: [77](#ife611127b0c9404b8cdc4fe0d4e43090_94)] [added: [79](#i188fc563ffb148b9b286ce1260535818_100)] | | |
| [Item [removed: 9.](#ife611127b0c9404b8cdc4fe0d4e43090_175)] [added: 9.](#i188fc563ffb148b9b286ce1260535818_184)] | | | [Changes in and Disagreements With Accountants on Accounting and Financial [removed: Disclosure](#ife611127b0c9404b8cdc4fe0d4e43090_175)] [added: Disclosure](#i188fc563ffb148b9b286ce1260535818_184)] | | | [removed: [116](#ife611127b0c9404b8cdc4fe0d4e43090_175)] [added: [121](#i188fc563ffb148b9b286ce1260535818_184)] | | |
| [Item [removed: 9A.](#ife611127b0c9404b8cdc4fe0d4e43090_178)] [added: 9A.](#i188fc563ffb148b9b286ce1260535818_187)] | | | [Controls and [removed: Procedures](#ife611127b0c9404b8cdc4fe0d4e43090_178)] [added: Procedures](#i188fc563ffb148b9b286ce1260535818_187)] | | | [removed: [116](#ife611127b0c9404b8cdc4fe0d4e43090_178)] [added: [122](#i188fc563ffb148b9b286ce1260535818_187)] | | |
| [Item [removed: 9B.](#ife611127b0c9404b8cdc4fe0d4e43090_181)] [added: 9B.](#i188fc563ffb148b9b286ce1260535818_190)] | | | [Other [removed: Information](#ife611127b0c9404b8cdc4fe0d4e43090_181)] [added: Information](#i188fc563ffb148b9b286ce1260535818_190)] | | | [removed: [119](#ife611127b0c9404b8cdc4fe0d4e43090_181)] [added: [124](#i188fc563ffb148b9b286ce1260535818_190)] | | |
| [Item [removed: 9C.](#ife611127b0c9404b8cdc4fe0d4e43090_649)] [added: 9C.](#i188fc563ffb148b9b286ce1260535818_193)] | | | [Disclosure Regarding Foreign Jurisdictions that Prevent [removed: Inspections](#ife611127b0c9404b8cdc4fe0d4e43090_649)] [added: Inspections](#i188fc563ffb148b9b286ce1260535818_193)] | | | [removed: [119](#ife611127b0c9404b8cdc4fe0d4e43090_649)] [added: [124](#i188fc563ffb148b9b286ce1260535818_193)] | | |
| [Item [removed: 10.](#ife611127b0c9404b8cdc4fe0d4e43090_187)] [added: 10.](#i188fc563ffb148b9b286ce1260535818_199)] | | | [Directors, Executive Officers and Corporate [removed: Governance](#ife611127b0c9404b8cdc4fe0d4e43090_187)] [added: Governance](#i188fc563ffb148b9b286ce1260535818_199)] | | | [removed: [119](#ife611127b0c9404b8cdc4fe0d4e43090_187)] [added: [124](#i188fc563ffb148b9b286ce1260535818_199)] | | |
| [Item [removed: 11.](#ife611127b0c9404b8cdc4fe0d4e43090_190)] [added: 11.](#i188fc563ffb148b9b286ce1260535818_202)] | | | [Executive [removed: Compensation](#ife611127b0c9404b8cdc4fe0d4e43090_190)] [added: Compensation](#i188fc563ffb148b9b286ce1260535818_202)] | | | [removed: [119](#ife611127b0c9404b8cdc4fe0d4e43090_190)] [added: [125](#i188fc563ffb148b9b286ce1260535818_202)] | | |
| [Item [removed: 12.](#ife611127b0c9404b8cdc4fe0d4e43090_193)] [added: 12.](#i188fc563ffb148b9b286ce1260535818_205)] | | | [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder [removed: Matters](#ife611127b0c9404b8cdc4fe0d4e43090_193)] [added: Matters](#i188fc563ffb148b9b286ce1260535818_205)] | | | [removed: [120](#ife611127b0c9404b8cdc4fe0d4e43090_193)] [added: [125](#i188fc563ffb148b9b286ce1260535818_205)] | | |
| [Item [removed: 13.](#ife611127b0c9404b8cdc4fe0d4e43090_196)] [added: 13.](#i188fc563ffb148b9b286ce1260535818_208)] | | | [Certain Relationships and Related Transactions, and Director [removed: Independence](#ife611127b0c9404b8cdc4fe0d4e43090_196)] [added: Independence](#i188fc563ffb148b9b286ce1260535818_208)] | | | [removed: [120](#ife611127b0c9404b8cdc4fe0d4e43090_196)] [added: [125](#i188fc563ffb148b9b286ce1260535818_208)] | | |
| [Item [removed: 14.](#ife611127b0c9404b8cdc4fe0d4e43090_199)] [added: 14.](#i188fc563ffb148b9b286ce1260535818_211)] | | | [Principal Accountant Fees and [removed: Services](#ife611127b0c9404b8cdc4fe0d4e43090_199)] [added: Services](#i188fc563ffb148b9b286ce1260535818_211)] | | | [removed: [120](#ife611127b0c9404b8cdc4fe0d4e43090_199)] [added: [125](#i188fc563ffb148b9b286ce1260535818_211)] | | |
| [Item [removed: 15.](#ife611127b0c9404b8cdc4fe0d4e43090_205)] [added: 15.](#i188fc563ffb148b9b286ce1260535818_217)] | | | [Exhibits, Financial Statement [removed: Schedules](#ife611127b0c9404b8cdc4fe0d4e43090_205)] [added: Schedules](#i188fc563ffb148b9b286ce1260535818_217)] | | | [removed: [120](#ife611127b0c9404b8cdc4fe0d4e43090_205)] [added: [125](#i188fc563ffb148b9b286ce1260535818_217)] | | |
| [Item [removed: 16.](#ife611127b0c9404b8cdc4fe0d4e43090_208)] [added: 16.](#i188fc563ffb148b9b286ce1260535818_220)] | | | [Form 10-K [removed: Summary](#ife611127b0c9404b8cdc4fe0d4e43090_208)] [added: Summary](#i188fc563ffb148b9b286ce1260535818_220)] | | | [removed: [123](#ife611127b0c9404b8cdc4fe0d4e43090_208)] [added: [129](#i188fc563ffb148b9b286ce1260535818_220)] | | |
- *the discovery, development, formulation, manufacturing and commercialization of our compounds, our drug candidates and JAKAFI®/JAKAVI®* *(ruxolitinib), PEMAZYRE®* *(pemigatinib), ICLUSIG®* *(ponatinib), MONJUVI®(tafasitamab-cxix)* */ MINJUVI®* *(tafasitamab), OPZELURA®* *(ruxolitinib) [removed: cream and] [added: cream,] ZYNYZ®* [removed: *(retifanlimab-dlwr);*][added: *(retifanlimab-dlwr) and NIKTIMVOTM* *(axatilimab);*]
- *the costs [added: and other financial impacts] associated with resolving matters in litigation and governmental proceedings;*
- *risks relating to our collaborators’ ability to develop and commercialize [removed: JAKAVI, OLUMIANT, TABRECTA] [added: drug products] and the drug candidates licensed from us;*
- *risks relating to governmental healthcare reform efforts, including efforts to control, set or cap pricing for our commercial drugs in the [removed: U.S] [added: U.S.] and abroad;*
- *developments in and expenses relating to [removed: litigation;*][added: litigation and governmental proceedings;*]
- *risks related to public health pandemics such as the COVID-19 pandemic, natural disasters, or geopolitical events such as the Russian invasion of [removed: Ukraine;] [added: Ukraine and conflicts in the Middle East;] and*
*Incyte, JAKAFI, MINJUVI, MONJUVI, OPZELURA, PEMAZYRE and ZYNYZ are our registered [removed: trademarks.][added: trademarks and NIKTIMVO is our trademark.]
- Our marketable securities and [removed: long term] [added: equity] investments are subject to risks that could adversely affect our overall financial position, and tax law changes could adversely affect our results of operations and financial condition.
| [PART I](#i188fc563ffb148b9b286ce1260535818_16) | | | | | | | | |
| [PART II](#i188fc563ffb148b9b286ce1260535818_70) | | | | | | | | |
| [PART III](#i188fc563ffb148b9b286ce1260535818_196) | | | | | | | | |
| [PART IV](#i188fc563ffb148b9b286ce1260535818_214) | | | | | | | | |
| [SIGNATURES](#i188fc563ffb148b9b286ce1260535818_223) | | | | | | [129](#i188fc563ffb148b9b286ce1260535818_223) | | |
| [PART I](#ife611127b0c9404b8cdc4fe0d4e43090_16) | | | | | | | | |
| [PART II](#ife611127b0c9404b8cdc4fe0d4e43090_67) | | | | | | | | |
| [PART III](#ife611127b0c9404b8cdc4fe0d4e43090_184) | | | | | | | | |
| [PART IV](#ife611127b0c9404b8cdc4fe0d4e43090_202) | | | | | | | | |
| [SIGNATURES](#ife611127b0c9404b8cdc4fe0d4e43090_211) | | | | | | [123](#ife611127b0c9404b8cdc4fe0d4e43090_211) | | |
Item 2. Properties
3 rewritten, 2 added, 0 removed, 3 unchanged
We own three buildings comprising approximately [removed: 544,000] [added: 541,000] square feet of laboratory and office space at this site.
We lease approximately [removed: 112,000] [added: 116,000] square feet of office space in Chadds Ford, Pennsylvania.
We also conduct clinical development and commercial operations from our European headquarters in Morges, Switzerland and our [removed: Japanese office] [added: Tokyo and Shanghai offices] in [removed: Tokyo.][added: East Asia.]
In May 2024, we purchased additional property in Wilmington, Delaware, including land, office buildings and parking garages, adding an additional approximately 517,000 square feet of office space in Wilmington, Delaware.
The acquired office buildings are undergoing renovations and we currently expect to occupy the office buildings in 2026.
Item 4. Mine Safety Disclosures
12 rewritten, 16 added, 14 removed, 39 unchanged
*Hervé Hoppenot,* age [removed: 64,] [added: 65,] joined Incyte as President and Chief Executive Officer and a Director in January 2014 and was appointed Chairman of the Board in May 2015.
Prior to joining Novartis, Mr. Hoppenot served in various increasingly senior roles at Aventis S.A. (formerly Rhône-Poulenc S.A.), a pharmaceutical company, including as Vice President Oncology [removed: US] [added: U.S.] of Aventis Pharmaceuticals, Inc. from 2000 to 2003 and Vice President [removed: US] [added: U.S.] Oncology Operations of Rhone-Poulenc Rorer Pharmaceuticals, Inc. from 1998 to 2000.
Cagnoni,* age [removed: 60,] [added: 62,] joined Incyte in June 2023 as President and Head of Research and Development.
Dr. Cagnoni received an M.D. from the University Buenos Aires School of [removed: Medicine,] [added: Medicine] and completed post-doctoral work in Hematology and Oncology at the Mount Sinai Medical Center, New York, and in Stem Cell Transplantation at the University of Colorado Health Sciences Center.
*Sheila Denton*, age [removed: 58,] [added: 59,] joined Incyte in October 2023 as Executive Vice President, General Counsel and Corporate Secretary.
[removed: Dickinson*,] [added: *Michael Morrissey*,] age [removed: 56,] [added: 61,] has served as Executive Vice President and [removed: General Manager, Europe,] [added: Head of Global Technical Operations] since June 2019 and joined Incyte [added: in January 2016] as [added: Corporate] Senior Vice President and [removed: General Manager, Europe in June 2016.][added: Head of Global Technical Operations.]
*Vijay Iyengar*, age [removed: 51,] [added: 52,] joined Incyte in May 2016 as Executive Vice President, Global Strategy and Corporate Development.
[removed: *Michael Morrissey*,] [added: Swain*,] age [removed: 60,] [added: 67,] has served as Executive Vice [removed: President and Head of Global Technical Operations] [added: President, Human Resources] since [removed: June 2019] [added: August 2002] and joined Incyte [removed: in January 2016] as [removed: Corporate] Senior Vice President [removed: and Head] of [removed: Global Technical Operations.][added: Human Resources in January 2002.]
*Christiana Stamoulis,* age [removed: 53,] [added: 54,] joined Incyte in February 2019 as Executive Vice President and Chief Financial Officer.
[removed: From 2009 until December 2013,] [added: Prior to joining Unum,] Ms. Stamoulis was a Senior Vice President of Corporate Strategy and Business Development at Vertex Pharmaceuticals, Inc., a biopharmaceutical company.
*Steven Stein,* age [removed: 57,] [added: 58,] has served as Executive Vice President and Chief Medical Officer since May 2016 and joined Incyte as Senior Vice President and Chief Medical Officer in March 2015.
Prior to joining Incyte, from May 2011 to February 2015, he was the Senior Vice President, [removed: US] [added: U.S.] Clinical Development & Medical Affairs at Novartis Pharmaceuticals.
*Lee Heeson,* age 54, joined Incyte in October 2024 as Executive Vice President, Incyte International.
Prior to joining Incyte, Mr. Heeson was Executive Vice President, Commercial International, of Seagen Inc., a biopharmaceutical company, from February 2022 to September 2024.
From February 2020 to February 2022, he was President International of Vifor Pharma Ltd., a pharmaceuticals company.
From October 2013 to January 2020, he held senior roles at Celgene Corporation, a biopharmaceutical company, most recently as President of Worldwide Markets, Inflammation & Immunology.
Earlier in his career, Mr. Heeson held leadership positions at Galderma and Schering-Plough.
Mr. Heeson holds a B.A., with honors, from Sheffield Hallam University.
*Mohamed Issa,* age 42, joined Incyte in January 2025 as Executive Vice President, Head of US Oncology.
He has almost 20 years of global leadership experience in pharmaceuticals, consumer healthcare and med-tech, with expertise spanning strategy, commercialization and business development.
Before joining Incyte, he spent 13 years at Johnson & Johnson, where he held senior roles leading U.S. Immunology, Neuroscience and Oncology businesses, most recently as Senior Vice President, US Immunology of Janssen Pharmaceuticals.
Earlier in his career, he was co-founder and CEO of a consumer healthcare company and held various roles in sales, brand management and strategy in biopharmaceuticals.
Dr. Issa holds a Pharm.D. from St. John’s University and an M.B.A. in finance and economics from New York University’s Stern School of Business.
*Matteo Trotta,* age 46, joined Incyte as Executive Vice President, General Manager, Dermatology US in March 2024.
Prior to joining Incyte, Mr. Trotta served as the Head of Novartis U.S. Immunology, where he led a 400-person organization across dermatology, rheumatology, auto-inflammatory, rare diseases and allergy.
He additionally held leadership roles in U.S. marketing and sales, enterprise strategy and global manufacturing and quality.
Before joining Novartis in 2012, he was an Engagement Manager at McKinsey & Company, where he served pharmaceutical and payer clients as part of their healthcare practice.
Mr. Trotta received his Engineering Degree from Politecnico di Torino, his M.S. in Engineering from the University of Illinois Chicago, and his M.B.A. from Columbia Business School.
*Jonathan E.
Mr. Dickinson joined Incyte from ARIAD Pharmaceuticals (Luxembourg) S.à.r.l, the parent company of ARIAD Pharmaceuticals, Inc.’s European subsidiaries responsible for the development and commercialization of ICLUSIG in the European Union and other countries, where he most recently held the position of Senior Vice President and General Manager, Europe.
Prior to joining ARIAD in February 2013, Mr. Dickinson served as European oncology brand lead at Bristol-Myers Squibb, a pharmaceutical company, and before that, he held several key leadership positions, including lifecycle leader, during his 13-year tenure at Hoffmann-La Roche, a pharmaceutical company.
At Roche, he had assignments both in the United States and Switzerland that included leadership roles for Roche’s three leading oncology medicines.
Mr. Dickinson began his career at Novartis, where he held commercial roles in its oncology and endocrinology businesses, including medical sales, product manager and business director in the United Kingdom.
Mr. Dickinson received a B.S. in Genetics and an M.B.A. from the University of Nottingham.
*Barry P.
Flannelly*, age 66, has served as Executive Vice President and General Manager, North America since June 2015 and joined Incyte as Executive Vice President, Business Development and Strategic Planning in August 2014.
Prior to joining Incyte, he served as Chief Executive Officer of OSS Healthcare Inc., a biotechnology start-up company, from August 2013 to July 2014.
He served as Vice President, Global Product Strategy and Commercial Planning of Nektar Therapeutics, a biopharmaceutical company, from April 2011 until April 2013, and as Senior Vice President, Commercial, of Onyx Pharmaceuticals, Inc., a biopharmaceutical company, from August 2008 until January 2011.
Prior thereto, Dr. Flannelly held key positions at biopharmaceutical and pharmaceutical companies such as Abraxis BioScience, Inc. and Novartis.
Dr. Flannelly earned his doctorate in pharmacy from the University of Maryland, School of Pharmacy, his master’s degree in business administration from the University of Baltimore, and his B.S. in Pharmacy from Massachusetts College of Pharmacy.
From January 2014 until she joined Unum, Ms. Stamoulis was an independent advisor to biopharmaceutical companies.
Swain*, age 66, has served as Executive Vice President, Human Resources since August 2002 and joined Incyte as Senior Vice President of Human Resources in January 2002.
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
1 rewritten, 0 added, 0 removed, 1 unchanged
Our common stock, $.001 par value per share, is traded on The Nasdaq Global Select Market under the symbol “INCY.” As of December 31, [removed: 2023,] [added: 2024,] our common stock was held by [removed: 112] [added: 107] stockholders of record.
Item 8. Financial Statements and Supplementary Data
409 rewritten, 247 added, 126 removed, 632 unchanged
| [Report of Ernst & Young LLP, Independent Registered Public Accounting [removed: Firm](#ife611127b0c9404b8cdc4fe0d4e43090_97)] [added: Firm](#i188fc563ffb148b9b286ce1260535818_103)] (PCAOB ID: 42) | | | [removed: [78](#ife611127b0c9404b8cdc4fe0d4e43090_97)] [added: [80](#i188fc563ffb148b9b286ce1260535818_103)] | | |
| [Consolidated Balance Sheets as of December 31, [removed: 202](#ife611127b0c9404b8cdc4fe0d4e43090_100)[3](#ife611127b0c9404b8cdc4fe0d4e43090_100)] [added: 202](#i188fc563ffb148b9b286ce1260535818_106)[4](#i188fc563ffb148b9b286ce1260535818_106)] [and [removed: 202](#ife611127b0c9404b8cdc4fe0d4e43090_100)[2](#ife611127b0c9404b8cdc4fe0d4e43090_100)] [added: 20](#i188fc563ffb148b9b286ce1260535818_106)[23](#i188fc563ffb148b9b286ce1260535818_106)] | | | [removed: [80](#ife611127b0c9404b8cdc4fe0d4e43090_100)] [added: [83](#i188fc563ffb148b9b286ce1260535818_106)] | | |
| [Consolidated Statements of Operations for the years ended December 31, [removed: 202](#ife611127b0c9404b8cdc4fe0d4e43090_103)[3](#ife611127b0c9404b8cdc4fe0d4e43090_103)[, 202](#ife611127b0c9404b8cdc4fe0d4e43090_103)[2](#ife611127b0c9404b8cdc4fe0d4e43090_103)] [added: 202](#i188fc563ffb148b9b286ce1260535818_109)[4](#i188fc563ffb148b9b286ce1260535818_109)[, 202](#i188fc563ffb148b9b286ce1260535818_109)[3](#i188fc563ffb148b9b286ce1260535818_109)] [and [removed: 202](#ife611127b0c9404b8cdc4fe0d4e43090_103)[1](#ife611127b0c9404b8cdc4fe0d4e43090_103)] [added: 20](#i188fc563ffb148b9b286ce1260535818_109)[2](#i188fc563ffb148b9b286ce1260535818_109)[2](#i188fc563ffb148b9b286ce1260535818_109)] | | | [removed: [81](#ife611127b0c9404b8cdc4fe0d4e43090_103)] [added: [84](#i188fc563ffb148b9b286ce1260535818_109)] | | |
| [Consolidated Statements of [removed: Comprehensive](#ife611127b0c9404b8cdc4fe0d4e43090_106) [Income](#ife611127b0c9404b8cdc4fe0d4e43090_106) [(Loss)](#ife611127b0c9404b8cdc4fe0d4e43090_106) [for] [added: Comprehensive Income (Loss) for] the years ended December 31, [removed: 202](#ife611127b0c9404b8cdc4fe0d4e43090_106)[3](#ife611127b0c9404b8cdc4fe0d4e43090_106)[, 202](#ife611127b0c9404b8cdc4fe0d4e43090_106)[2](#ife611127b0c9404b8cdc4fe0d4e43090_106)] [added: 202](#i188fc563ffb148b9b286ce1260535818_112)[4](#i188fc563ffb148b9b286ce1260535818_112)[, 202](#i188fc563ffb148b9b286ce1260535818_112)[3](#i188fc563ffb148b9b286ce1260535818_112)] [and [removed: 202](#ife611127b0c9404b8cdc4fe0d4e43090_106)[1](#ife611127b0c9404b8cdc4fe0d4e43090_106)] [added: 20](#i188fc563ffb148b9b286ce1260535818_112)[2](#i188fc563ffb148b9b286ce1260535818_112)[2](#i188fc563ffb148b9b286ce1260535818_112)] | | | [removed: [82](#ife611127b0c9404b8cdc4fe0d4e43090_106)] [added: [85](#i188fc563ffb148b9b286ce1260535818_112)] | | |
| [Consolidated Statements of Stockholders’ Equity for the years ended December 31, [removed: 202](#ife611127b0c9404b8cdc4fe0d4e43090_109)[3](#ife611127b0c9404b8cdc4fe0d4e43090_109)[, 202](#ife611127b0c9404b8cdc4fe0d4e43090_109)[2](#ife611127b0c9404b8cdc4fe0d4e43090_109)] [added: 202](#i188fc563ffb148b9b286ce1260535818_115)[4](#i188fc563ffb148b9b286ce1260535818_115)[, 202](#i188fc563ffb148b9b286ce1260535818_115)[3](#i188fc563ffb148b9b286ce1260535818_115)] [and [removed: 202](#ife611127b0c9404b8cdc4fe0d4e43090_109)[1](#ife611127b0c9404b8cdc4fe0d4e43090_109)] [added: 20](#i188fc563ffb148b9b286ce1260535818_115)[2](#i188fc563ffb148b9b286ce1260535818_115)[2](#i188fc563ffb148b9b286ce1260535818_115)] | | | [removed: [83](#ife611127b0c9404b8cdc4fe0d4e43090_109)] [added: [86](#i188fc563ffb148b9b286ce1260535818_115)] | | |
| [Consolidated Statements of Cash Flows for the years ended December 31, [removed: 202](#ife611127b0c9404b8cdc4fe0d4e43090_112)[3](#ife611127b0c9404b8cdc4fe0d4e43090_112)[, 202](#ife611127b0c9404b8cdc4fe0d4e43090_112)[2](#ife611127b0c9404b8cdc4fe0d4e43090_112)] [added: 202](#i188fc563ffb148b9b286ce1260535818_118)[4](#i188fc563ffb148b9b286ce1260535818_118)[, 202](#i188fc563ffb148b9b286ce1260535818_118)[3](#i188fc563ffb148b9b286ce1260535818_118)] [and [removed: 202](#ife611127b0c9404b8cdc4fe0d4e43090_112)[1](#ife611127b0c9404b8cdc4fe0d4e43090_112)] [added: 20](#i188fc563ffb148b9b286ce1260535818_118)[2](#i188fc563ffb148b9b286ce1260535818_118)[2](#i188fc563ffb148b9b286ce1260535818_118)] | | | [removed: [84](#ife611127b0c9404b8cdc4fe0d4e43090_112)] [added: [87](#i188fc563ffb148b9b286ce1260535818_118)] | | |
| [Notes to the Consolidated Financial [removed: Statements](#ife611127b0c9404b8cdc4fe0d4e43090_115)] [added: Statements](#i188fc563ffb148b9b286ce1260535818_121)] | | | [removed: [85](#ife611127b0c9404b8cdc4fe0d4e43090_115)] [added: [88](#i188fc563ffb148b9b286ce1260535818_121)] | | |
We have audited the accompanying consolidated balance sheets of Incyte Corporation (the Company) as of December 31, [removed: 2023] [added: 2024] and [removed: 2022,] [added: 2023,] the related consolidated statements of operations, comprehensive income (loss), stockholders’ equity and cash flows for each of the three years in the period ended December 31, [removed: 2023,] [added: 2024,] and the related notes (collectively referred to as the “consolidated financial statements”).
In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, [removed: 2023] [added: 2024] and [removed: 2022,] [added: 2023,] and the results of its operations and its cash flows for each of the three years in the period ended December 31, [removed: 2023,] [added: 2024,] in conformity with U.S. generally accepted accounting principles.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company’s internal control over financial reporting as of December 31, [removed: 2023,] [added: 2024,] based on criteria established in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 [removed: framework)] [added: framework),] and our report dated February [removed: 13, 2024] [added: 10, 2025] expressed an unqualified opinion thereon.
Critical Audit [removed: Matter][added: Matters]
The critical audit [removed: matter] [added: matters] communicated below [removed: is a matter] [added: are matters] arising from the current period audit of the financial statements that [removed: was] [added: were] communicated or required to be communicated to the audit committee and that: (1) [removed: relates] [added: relate] to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective or complex judgments.
The communication of [removed: the] critical audit [removed: matter] [added: matters] does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit [removed: matter] [added: matters] below, providing [removed: a] separate [removed: opinion] [added: opinions] on the critical audit [removed: matter] [added: matters] or on the accounts or disclosures to which [removed: it relates.][added: they relate.]
| *Description of the Matter* | | | As discussed in Note 1 to the consolidated financial statements, the Company recognizes revenues for product received by its customers net of allowances for customer credits, including estimated rebates, chargebacks, discounts, returns, distribution service fees, patient assistance programs, and government rebates. Liabilities related to sales allowances are presented within accrued and other current liabilities on the consolidated balance sheet and totaled [removed: $279.9] [added: $431.8] million as of December 31, [removed: 2023.] [added: 2024.] Auditing the allowances for rebates owed pursuant to the Medicaid Drug Rebate Program in the U.S. was complex and highly judgmental due to the significant estimation uncertainty involved in management’s assumptions, including the levels of expected utilization of these rebates based on the amount of drugs sold to eligible patients, as well as the complexity of the government mandated calculations. The allowances for rebates owed pursuant to the Medicaid Drug Rebate Program in the U.S. are sensitive to these significant assumptions and calculations. | | |
| | | | [added: 2024 | | | | | |] 2023 | | | | | | 2022 | | |
| Cash and cash equivalents | | | $ | [removed: 3,213,376] [added: 1,687,829] | | | | | $ | [removed: 2,951,422] [added: 3,213,376] | |
| Marketable securities—available-for-sale (amortized cost [removed: $442,816] [added: $469,917] and [removed: $292,580] [added: $442,816] as of December 31, [removed: 2023] [added: 2024] and [removed: 2022] [added: 2023] respectively; allowance for credit losses $0 as of December 31, [removed: 2023] [added: 2024] and [removed: 2022)] [added: 2023)] | | | [removed: 442,667] [added: 470,263] | | | | | | [removed: 287,543] [added: 442,667] | | |
| Accounts receivable | | | [removed: 743,557] [added: 853,154] | | | | | | [removed: 644,879] [added: 743,557] | | |
| Inventory | | | [removed: 62,972] [added: 58,872] | | | | | | [removed: 41,995] [added: 62,972] | | |
| Prepaid expenses and other current assets | | | [removed: 182,830] [added: 168,912] | | | | | | [removed: 167,011] [added: 182,830] | | |
| Total current assets | | | [removed: 4,645,402] [added: 3,239,030] | | | | | | [removed: 4,092,850] [added: 4,645,402] | | |
| Restricted cash | | | [removed: 1,845] [added: 1,622] | | | | | | [removed: 1,698] [added: 1,845] | | |
| Long term [added: equity] investments | | | [removed: 187,716] [added: 18,814] | | | | | | [removed: 133,676] [added: 187,716] | | |
| Inventory | | | [removed: 206,965] [added: 348,327] | | | | | | [removed: 78,964] [added: 206,965] | | |
| Property and equipment, net | | | [removed: 751,513] [added: 763,411] | | | | | | [removed: 739,310] [added: 751,513] | | |
| Finance lease right-of-use assets, net | | | [removed: 25,535] [added: 30,803] | | | | | | [removed: 26,298] [added: 25,535] | | |
| Other intangible assets, net | | | [removed: 123,545] [added: 113,803] | | | | | | [removed: 129,219] [added: 123,545] | | |
| Deferred income tax asset | | | [removed: 631,886] [added: 762,071] | | | | | | [removed: 457,941] [added: 631,886] | | |
| Other assets, net | | | [removed: 52,107] [added: 10,848] | | | | | | [removed: 25,435] [added: 52,107] | | |
| Total assets | | | $ | [removed: 6,782,107] [added: 5,444,322] | | | | | $ | [removed: 5,840,984] [added: 6,782,107] | |
| Accounts payable | | | $ | [removed: 109,601] [added: 197,465] | | | | | $ | [removed: 277,546] [added: 109,601] | |
| Accrued compensation | | | [removed: 153,348] [added: 188,677] | | | | | | [removed: 138,761] [added: 153,348] | | |
| Accrued and other current liabilities | | | [removed: 935,569] [added: 1,212,048] | | | | | | [removed: 701,053] [added: 935,569] | | |
| Finance lease liabilities | | | [removed: 3,439] [added: 4,419] | | | | | | [removed: 3,179] [added: 3,439] | | |
| Acquisition-related contingent consideration | | | [removed: 38,422] [added: 39,238] | | | | | | [removed: 36,538] [added: 38,422] | | |
| Total current liabilities | | | [removed: 1,240,379] [added: 1,641,847] | | | | | | [removed: 1,157,077] [added: 1,240,379] | | |
| Acquisition-related contingent consideration | | | [removed: 173,578] [added: 153,762] | | | | | | [removed: 184,462] [added: 173,578] | | |
| Finance lease liabilities | | | [removed: 29,162] [added: 33,542] | | | | | | [removed: 30,083] [added: 29,162] | | |
| Other liabilities | | | [removed: 149,151] [added: 167,543] | | | | | | [removed: 99,243] [added: 149,151] | | |
| Total liabilities | | | [removed: 1,592,270] [added: 1,996,694] | | | | | | [removed: 1,470,865] [added: 1,592,270] | | |
| | | | Evaluating the fair value of the in-process research and development assets acquired in the Escient Pharmaceutics, Inc. acquisition | | |
| | | | | | |
| *Description of the Matter* | | | As described in Note 5 to the consolidated financial statements, on May 30, 2024, the Company acquired all of the outstanding shares of common stock of Escient Pharmaceuticals, Inc. (“Escient”), a clinical-stage drug development company, for $782.5 million in cash consideration. The Company determined substantially all of the fair value of the gross assets acquired was concentrated in Escient’s lead clinical-stage molecule, EP262. Therefore, the Company accounted for the Escient transaction as an asset acquisition under U.S. GAAP. The acquired in-process research and development asset for EP262 was valued at $644.8 million, with an additional $34.6 million of fair value allocated to the secondary molecule, EP547. As both acquired in-process research and development assets do not have an alternative future use at the acquisition date, the Company recognized the full amount of $679.4 million as research and development expenses. Auditing the Company’s fair value of the in-process research and development assets acquired in the Escient transaction was judgmental due to the significant estimation uncertainty and subjectivity of the significant assumptions used by management in determining the present value of future discounted cash flows. The significant assumptions used in the calculation of the fair value of the in-process research and development assets of Escient included the amount of future product revenues, the probability of success, and the discount rate. The fair value calculation of the in-process research and development assets are sensitive to these significant assumptions. | | |
| | | | | | |
| | | | | | |
| *How We Addressed the Matter in Our Audit* | | | We obtained an understanding, evaluated the design and tested the operating effectiveness of controls over management’s review of the estimation of the fair value of the in-process research and development assets of Escient. For example, we tested controls over management’s review of the significant assumptions, such as the amount of future product revenues, the probability of success, and the discount rate, and over the completeness and accuracy of the data used in the valuation. To test the fair value of the in-process research and development assets, we performed audit procedures that included, among others, evaluating the Company's methodologies used and testing the significant assumptions discussed above. For example, we compared the significant assumptions used by management to current published scientific studies, industry, market and economic trends, and to other relevant factors. In addition, to evaluate the probability of success, we considered the phase of development of the in-process research and development assets against third-party data regarding clinical trial success rates. We also performed various sensitivity analyses of the significant assumptions to evaluate the change in the fair value of the in-process research and development assets resulting from changes in the assumptions. In addition, we involved our valuation specialists to assist in our evaluation of the methodologies and the discount rates used in the fair value estimate. | | |
February 10, 2025
| | | | 2024 | | | | | | 2023 | | |
| Interest income | | | 128,710 | | | | | | 158,414 | | | | | | 40,451 | | |
| Other, net | | | 12,809 | | | | | | 13,934 | | | | | | (519) | | |
| Net income | | | $ | 32,615 | | | | | $ | 597,599 | | | | | $ | 340,660 | |
| Stock compensation | | | — | | | | | | 266,058 | | | | | | — | | | | | | — | | | | | | 266,058 | | |
| Repurchase of common stock | | | (33) | | | | | | (758,061) | | | | | | — | | | | | | (1,265,881) | | | | | | (2,023,975) | | |
| Balances at December 31, 2024 | | | $ | 193 | | | | | $ | 4,533,437 | | | | | $ | (13,121) | | | | | $ | (1,072,881) | | | | | $ | 3,447,628 | |
| Net income | | | $ | 32,615 | | | | | $ | 597,599 | | | | | $ | 340,660 | |
| Loss on change in fair value of acquisition-related contingent consideration | | | 19,803 | | | | | | 29,202 | | | | | | 12,149 | | |
| Sale of equity investments | | | 284,781 | | | | | | 45 | | | | | | — | | |
| Repurchase of common stock | | | (2,004,790) | | | | | | — | | | | | | — | | |
| Unpaid excise tax on repurchase of common stock | | | $ | 19,185 | | | | | $ | — | | | | | $ | — | |
*Reclassifications.* Certain prior year amounts have been reclassified for consistency with the current year presentation.
These reclassifications had no effect on the reported results of operations.
The tax effects of global intangible low-taxed income from certain foreign subsidiaries is recognized in the income tax provision in the period the tax arises.
Product shipping and handling costs are included in cost of product revenues.
For licenses that are not
*Profit sharing from co-commercialization activities.* In profit sharing arrangements where we are deemed to be the principal, we record 100% of all revenues and expenses associated with the co-commercialization activities.
We record our collaboration partner's share of profit or loss to cost of product revenues within our consolidated statement of operations.
Other components of make-whole payments between us and our collaboration partners are classified in our consolidated statement of operations based on the nature of the underlying payable or receivable.
In profit sharing arrangements where we are deemed to be the agent, we record our share of profit or loss from co-commercialization activities to (profit) and loss sharing under collaboration agreements within our consolidated statement of operations.
Other components of make-whole payments between us and our collaboration partners are classified in our consolidated statement of operations based on the nature of the underlying payable or receivable.
See Note 17 for additional disclosures.
In March 2024, the SEC issued Release Nos. 33-11275; 34-99678 “*The Enhancement and Standardization of Climate-Related Disclosures for Investors*” to require public companies to provide certain climate-related information in their registration statements and annual reports.
The compliance dates for the rules amended by this release begin in fiscal year 2025 for large accelerated filers.
On April 4, 2024, the SEC issued an order staying the newly adopted rules.
We are currently evaluating the impact of this release on our financial disclosures.
In November 2024, the FASB issued ASU No. 2024-03, “*Disaggregation of Income Statement Expenses* (DISE).” This new guidance applies to all public entities and requires disclosures about specific types of expenses included in the expense captions presented on the face of the income statement as well as disclosures about selling expenses.
Public entities must adopt the new standard prospectively for fiscal years beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027.
| | | | 2024 | | | | | | 2023 | | | | | | 2022 | | |
| Milestone and contract revenues | | | 43,000 | | | | | | 7,000 | | | | | | 165,000 | | |
| December 31, 2024 | | | | | | | | | | | | | | | | | | | | |
| Debt securities (government) | | | $ | 469,917 | | | | | $ | 971 | | $ | (625) | | | | | $ | 470,263 | |
February 13, 2024
| | | | | | | | | | | | |
| Interest income and other, net | | | 172,348 | | | | | | 39,932 | | | | | | 10,647 | | |
| Balances at December 31, 2020 | | | $ | 219 | | | | | $ | 4,352,864 | | | | | $ | (15,360) | | | | | $ | (1,726,455) | | | | | $ | 2,611,268 | |
| Stock compensation | | | — | | | | | | 185,129 | | | | | | — | | | | | | — | | | | | | 185,129 | | |
In the fourth quarter of 2021 and fiscal year 2022 for non-covered patients of OPZELURA, we offered a full buy-down program as we were in the process of obtaining commercial insurance coverage for OPZELURA.
During 2022, we contracted with the three largest group purchasing organizations to obtain coverage for OPZELURA.
All full buy-down programs for OPZELURA ended effective January 31, 2023.
Our estimates for expected utilization of commercial insurance rebates are based on data received from our customers.
During the fourth quarter of 2021 and fiscal year 2022, we also offered a full buy-down program to non-covered patients of OPZELURA as we were obtaining commercial insurance coverage for OPZELURA.
| | | | | | | | | | | | | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| December 31, 2022 | | | | | | | | | | | | | | | | | | | | | | | |
| Debt securities (government) | | | $ | 292,580 | | | | | | | | | | | $ | (5,037) | | | | | $ | 287,543 | |
Our available-for-sale debt securities generally have contractual maturity dates of between 12 to 18 months.
| Total assets | | | $ | 3,085,098 | | | | | $ | 287,543 | | | | | $ | — | | | | | $ | 3,372,641 | |
On November 17, 2022, we completed our acquisition of 100% of the outstanding shares of Villaris Therapeutics, Inc. ("Villaris").
Villaris was an early-stage biopharma company focused on the development of novel antibody therapeutics for vitiligo.
Therefore, the transaction was accounted for as an asset acquisition.
Under the terms of the acquisition agreement, we made an upfront payment of $70.3 million in 2022, which was attributed to the fair value of the preclinical asset acquired.
As the preclinical asset had no alternative future use at the date of acquisition, the entire upfront payment amount was expensed to research and development expense on the consolidated statement of operations for the year ended December 31, 2022.
There were no material assets or liabilities recorded on the consolidated balance sheet as part of this acquisition.
During December 2023, we made a $20.0 million development milestone payment to former Villaris stockholders for the initiation of the Phase 1 clinical trial of INCA034460 as a treatment for vitiligo, which was expensed to research and development expense on the consolidated statement of operations for the year ended December 31, 2023.
Former Villaris stockholders are eligible to receive up to an additional $290.0 million upon achievement of certain regulatory milestones, as well as up to an additional $1.05 billion in commercial milestones on net sales of commercialized products.
We will accrue for these milestone payments in the future when it becomes probable they will be achieved.
In September 2023, we recognized a $5.0 million regulatory milestone for the approval of JAKAVI (ruxolitinib) in GVHD by the Japanese Ministry of Health, Labour and Welfare.
In May 2020, we amended our agreement with Lilly to enable Lilly to develop and commercialize baricitinib for the treatment of COVID-19.
As part of the amended agreement, in addition to the royalties described above, we will be entitled to receive additional royalty payments with rates in the low teens on global net sales of baricitinib for the treatment of COVID-19 that exceed a specified aggregate global net sales threshold.
Lilly – Ruxolitinib
In March 2016, we entered into an amendment to the agreement with Lilly that amended the non-compete provision of the agreement to allow us to engage in the development and commercialization of ruxolitinib in the GVHD field.
Lilly was eligible to receive up to $40.0 million in milestone payments relating to ruxolitinib in the GVHD field.
During January 2023, August 2023 and December 2023, we paid Merus milestones of $2.5 million, $2.5 million and $1.0 million, respectively, which were recorded as research and development expense in our consolidated statements of operations.
During August 2023, we purchased approximately 0.5 million shares of Merus’ common shares for an aggregate purchase price of $10.0 million in cash.
As of December 31, 2023, we held an investment of approximately 4.0 million Merus common shares.
In July 2022, we amended our agreement with MacroGenics to reflect changes related to the payment of certain milestones and paid MacroGenics $30.0 million, which was recorded as research and development expense in our consolidated statements of operations in the third quarter of 2022.
In March 2023, we made a $15.0 million regulatory milestone payment to MacroGenics for the FDA approval of ZYNYZ for the treatment of adults with Merkel cell carcinoma.
Since the inception of the agreement through December 31, 2023, we have paid MacroGenics developmental and regulatory milestones totaling $115.0 million.
Syros
In January 2018, we entered into a Target Discovery, Research Collaboration and Option Agreement with Syros Pharmaceuticals, Inc. (“Syros”).
Under this agreement, Syros used its proprietary gene control platform to identify novel therapeutic targets with a focus in myeloproliferative neoplasms and we received options to obtain exclusive worldwide rights to intellectual property resulting from the collaboration for up to seven validated targets.
An excerpt. Shown here: 40 of 409 rewritten, 40 of 247 added and 40 of 126 removed. The counts are complete. For every sentence, read Item 8. Financial Statements and Supplementary Data in the FY2024 filing and the FY2023 filing.
Item 9A. Controls and Procedures
6 rewritten, 1 added, 1 removed, 28 unchanged
*Changes in internal control over financial reporting.* There were no changes in our internal control over financial reporting (as defined in Rule 13a-15(f) under the Exchange Act) for the quarter ended December 31, [removed: 2023,] [added: 2024,] that have materially affected or are reasonably likely to materially affect our internal control over financial reporting.
Based on our evaluation under the framework in *Internal Control—Integrated Framework*, our management concluded that our internal control over financial reporting was effective as of December 31, [removed: 2023.][added: 2024.]
The effectiveness of our internal control over financial reporting as of December 31, [removed: 2023] [added: 2024] has been audited by Ernst & Young LLP, an independent registered public accounting firm, as stated in their report which is included herein.
We have audited Incyte Corporation’s internal control over financial reporting as of December 31, [removed: 2023,] [added: 2024,] based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) (the COSO criteria).
In our opinion, Incyte Corporation (the Company) maintained, in all material respects, effective internal control over financial reporting as of December 31, [removed: 2023,] [added: 2024,] based on the COSO criteria.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheets of the Company as of December 31, [removed: 2023] [added: 2024] and [removed: 2022,] [added: 2023,] the related consolidated statements of operations, comprehensive income (loss), stockholders’ equity and cash flows for each of the three years in the period ended December 31, [removed: 2023,] [added: 2024,] and the related notes and our report dated February [removed: 13, 2024] [added: 10, 2025] expressed an unqualified opinion thereon.
February 10, 2025
February 13, 2024
Item 9B. Other Information
2 rewritten, 3 added, 0 removed, 0 unchanged
(b) During the three months ended December 31, [removed: 2023, no director of officer] [added: 2024, the following officers] (as defined in Rule 16a-1(f) under the Securities Exchange Act of 1934) of our Company adopted a prearranged trading plan relating to our common stock and intended to satisfy the affirmative defense of Rule 10b5–1(c) under the Securities Exchange Act of 1934.
During the three months ended December 31, [removed: 2023,] [added: 2024,] no director or officer (as defined in Rule 16a-1(f) under the Securities Exchange Act of 1934) of our Company adopted or terminated any contract, instruction or written plan for the purchase or sale of our securities, whether or not intended to satisfy the affirmative defense conditions of Rule [removed: 10b5-1(c).][added: 10b5-1(c), other than as set forth above.]
Christiana Stamoulis*,* our Executive Vice President and Chief Financial Officer, adopted a trading plan on November 26, 2024 providing for the sale of up to an aggregate of 107,938 shares of our common stock until November 26, 2025.
Sheila Denton, our Executive Vice President and General Counsel, adopted a trading plan on November 27, 2024 providing for the sale of up to an aggregate of 32,014 shares of our common stock until November 27, 2025.
Barry Flannelly, our Executive Vice President and General Manager, North America, adopted a trading plan on December 13, 2024 providing for the sale of up to an aggregate of 315,415 shares of our common stock until January 6, 2026.
Item 10. Directors, Executive Officers and Corporate Governance
1 rewritten, 3 added, 0 removed, 17 unchanged
The information required by this item (with respect to Directors) is incorporated by reference from the information under the caption “Election of Directors” contained in our Proxy Statement to be filed with the Securities and Exchange Commission in connection with the solicitation of proxies for our [removed: 2024] [added: 2025] Annual Meeting of Stockholders to be held on June [removed: 12, 2024] [added: 10, 2025] (the “Proxy Statement”).
We have adopted our Policy on Insider Trading governing the purchase or sale of our securities by our officers, employees and members of the Board of Directors, as well as our contractors, consultants, secondees and temporary workers, that we believe is reasonably designed to promote compliance with insider trading laws, rules and regulations, and the listing standards of The Nasdaq Stock Market.
A copy of our Policy on Insider Trading is filed as Exhibit 19.1 to this Annual Report on Form 10-K.
Information regarding our policies and practices on the timing of equity awards will be included in the Proxy Statement and is incorporated herein by reference.
Item 15. Exhibits, Financial Statement Schedules
30 rewritten, 11 added, 6 removed, 41 unchanged
| 3(i) | | | | | | [Integrated copy of the Restated Certificate of Incorporation, as amended, of the Company (incorporated by reference to Exhibit 3(i) to the Company’s Annual Report on Form 10-K for the year ended December 31, [removed: 2009).](http://www.sec.gov/Archives/edgar/data/879169/000104746910001834/a2196849zex-3_i.htm)] [added: 2009).](https://www.sec.gov/Archives/edgar/data/879169/000104746910001834/a2196849zex-3_i.htm)] | | |
| 3(ii) | | | | | | [Bylaws of the Company, as amended as [removed: of](https://www.sec.gov/Archives/edgar/data/879169/000087916923000025/exhibit31-bylawsasamended0.htm) [July] [added: of July] 27, [removed: 2023](https://www.sec.gov/Archives/edgar/data/879169/000087916923000025/exhibit31-bylawsasamended0.htm) [(incorporated] [added: 2023 (incorporated] by reference to Exhibit 3.1 to the [removed: Company’s](https://www.sec.gov/Archives/edgar/data/879169/000087916923000025/exhibit31-bylawsasamended0.htm) [Quarterly](https://www.sec.gov/Archives/edgar/data/879169/000087916923000025/exhibit31-bylawsasamended0.htm) [Report] [added: Company’s Quarterly Report] on [removed: Form](https://www.sec.gov/Archives/edgar/data/879169/000087916923000025/exhibit31-bylawsasamended0.htm) [10-](https://www.sec.gov/Archives/edgar/data/879169/000087916923000025/exhibit31-bylawsasamended0.htm)[Q](https://www.sec.gov/Archives/edgar/data/879169/000087916923000025/exhibit31-bylawsasamended0.htm) [for] [added: Form 10-Q for] the quarter ended June 30, [removed: 2023](https://www.sec.gov/Archives/edgar/data/879169/000087916923000025/exhibit31-bylawsasamended0.htm)[).](https://www.sec.gov/Archives/edgar/data/879169/000087916923000025/exhibit31-bylawsasamended0.htm)] [added: 2023).](https://www.sec.gov/Archives/edgar/data/879169/000087916923000025/exhibit31-bylawsasamended0.htm)] | | |
| 4.1 | | | | | | [Form of Common Stock Certificate (incorporated by reference to the Exhibit 4.1 to the Company’s Annual Report on Form 10-K for the year ended December 31, [removed: 2002).](http://www.sec.gov/Archives/edgar/data/879169/000102140803005282/dex41.htm)] [added: 2002).](https://www.sec.gov/Archives/edgar/data/879169/000102140803005282/dex41.htm)] | | |
| 10.1# | | | | | | [Incyte Corporation Amended and Restated 2010 Stock Incentive Plan, as [removed: amended](https://www.sec.gov/Archives/edgar/data/879169/000110465923071561/tm2318718d1_ex10-1.htm) [on](https://www.sec.gov/Archives/edgar/data/879169/000110465923071561/tm2318718d1_ex10-1.htm) [](https://www.sec.gov/Archives/edgar/data/879169/000110465923071561/tm2318718d1_ex10-1.htm)[April] [added: amended on April] 13, [removed: 202](https://www.sec.gov/Archives/edgar/data/879169/000110465923071561/tm2318718d1_ex10-1.htm)[3](https://www.sec.gov/Archives/edgar/data/879169/000110465923071561/tm2318718d1_ex10-1.htm) [(incorporated] [added: 2023 (incorporated] by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K [removed: filed](https://www.sec.gov/Archives/edgar/data/879169/000110465923071561/tm2318718d1_ex10-1.htm) [June] [added: filed June] 15, [removed: 2023](https://www.sec.gov/Archives/edgar/data/879169/000110465923071561/tm2318718d1_ex10-1.htm)[).](https://www.sec.gov/Archives/edgar/data/879169/000110465923071561/tm2318718d1_ex10-1.htm)] [added: 2023).](https://www.sec.gov/Archives/edgar/data/879169/000110465923071561/tm2318718d1_ex10-1.htm)] | | |
| 10.5# | | | | | | [Form of Nonstatutory Stock Option Agreement for Outside Directors under the Incyte Corporation Amended and Restated 2010 Stock Incentive Plan (incorporated by reference to Exhibit 10.24 to the Company’s Annual Report on Form 10-K for the year ended December 31, [removed: 2013).](http://www.sec.gov/Archives/edgar/data/879169/000104746914001174/a2218324zex-10_24.htm)] [added: 2013).](https://www.sec.gov/Archives/edgar/data/879169/000104746914001174/a2218324zex-10_24.htm)] | | |
| 10.6# | | | | | | [Form of Restricted Stock Unit Award Agreement for Outside Directors under the Incyte Corporation Amended and Restated 2010 Stock Incentive Plan (incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, [removed: 2019).](http://www.sec.gov/Archives/edgar/data/879169/000155837019006550/incy-20190630ex101dc8f47.htm)] [added: 2019).](https://www.sec.gov/Archives/edgar/data/879169/000155837019006550/incy-20190630ex101dc8f47.htm)] | | |
| [removed: 10.7#] [added: 10.15#] | | | | | | Form of Indemnity Agreement between the Company and its directors and officers (incorporated by reference to Exhibit 10.5 to the Company’s Registration Statement on Form S-1 (File No. 33 68138)). | | |
| [removed: 10.8#] [added: 10.16#] | | | | | | [1997 Employee Stock Purchase Plan of Incyte Corporation, as [removed: amended](https://www.sec.gov/Archives/edgar/data/879169/000110465923071561/tm2318718d1_ex10-2.htm) [on] [added: amended on] April 13, [removed: 2023](https://www.sec.gov/Archives/edgar/data/879169/000110465923071561/tm2318718d1_ex10-2.htm) [(incorporated] [added: 2023 (incorporated] by reference to Exhibit [removed: 10.](https://www.sec.gov/Archives/edgar/data/879169/000110465923071561/tm2318718d1_ex10-2.htm)[2](https://www.sec.gov/Archives/edgar/data/879169/000110465923071561/tm2318718d1_ex10-2.htm) [to] [added: 10.2 to] the [removed: Company’s](https://www.sec.gov/Archives/edgar/data/879169/000110465923071561/tm2318718d1_ex10-2.htm) [Current R](https://www.sec.gov/Archives/edgar/data/879169/000110465923071561/tm2318718d1_ex10-2.htm)[eport] [added: Company’s Current Report] on [removed: Form](https://www.sec.gov/Archives/edgar/data/879169/000110465923071561/tm2318718d1_ex10-2.htm) [8-K] [added: Form 8-K] filed [removed: Jun](https://www.sec.gov/Archives/edgar/data/879169/000110465923071561/tm2318718d1_ex10-2.htm)[e] [added: June] 15, [removed: 2023](https://www.sec.gov/Archives/edgar/data/879169/000110465923071561/tm2318718d1_ex10-2.htm)[).](https://www.sec.gov/Archives/edgar/data/879169/000110465923071561/tm2318718d1_ex10-2.htm)] [added: 2023).](https://www.sec.gov/Archives/edgar/data/879169/000110465923071561/tm2318718d1_ex10-2.htm)] | | |
| [removed: 10.9#] [added: 10.17#] | | | | | | [Form of Employment Agreement between the Company and Barry P. Flannelly (effective as of August 11, 2014), Christiana Stamoulis (effective as of February 11, 2019), Steven H. Stein (effective as of March 2, 2015), Vijay K. Iyengar (effective as of May 9, [removed: 2016),](http://www.sec.gov/Archives/edgar/data/879169/000104746913001393/a2212845zex-10_14.htm) [Pablo] [added: 2016), Pablo] J. Cagnoni [removed: (effective](http://www.sec.gov/Archives/edgar/data/879169/000104746913001393/a2212845zex-10_14.htm) [as of](http://www.sec.gov/Archives/edgar/data/879169/000104746913001393/a2212845zex-10_14.htm) [June] [added: (effective as of June] 7, [removed: 2023](http://www.sec.gov/Archives/edgar/data/879169/000104746913001393/a2212845zex-10_14.htm)[)](http://www.sec.gov/Archives/edgar/data/879169/000104746913001393/a2212845zex-10_14.htm) [and] [added: 2023),] Sheila A. Denton [removed: (effective](http://www.sec.gov/Archives/edgar/data/879169/000104746913001393/a2212845zex-10_14.htm) [as] [added: (effective as] of October 2, [removed: 2023)](http://www.sec.gov/Archives/edgar/data/879169/000104746913001393/a2212845zex-10_14.htm) [(incorporated] [added: 2023), Matteo Trotta (effective as of March 25, 2024), Lee Heeson (effective as of October 1, 2024) and Mohamed Issa (effective as of January 6, 2025) (incorporated] by reference to Exhibit 10.14 to the Company’s Annual Report on Form 10-K for the year ended December 31, [removed: 2012).](http://www.sec.gov/Archives/edgar/data/879169/000104746913001393/a2212845zex-10_14.htm)] [added: 2012).](https://www.sec.gov/Archives/edgar/data/879169/000104746913001393/a2212845zex-10_14.htm)] | | |
| [removed: 10.10#] [added: 10.18#] | | | | | | [Form of Amended and Restated Employment Agreement, effective as of April 18, 2012, between the Company and Paula J. Swain (incorporated by reference to Exhibit 10.14 to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, [removed: 2012).](http://www.sec.gov/Archives/edgar/data/879169/000110465912029092/a12-6693_1ex10d14.htm)] [added: 2012).](https://www.sec.gov/Archives/edgar/data/879169/000110465912029092/a12-6693_1ex10d14.htm)] | | |
| [removed: 10.11#] [added: 10.19#] | | | | | | [Offer of Employment Letter, dated December 14, 2018, from the Company to Christiana Stamoulis (incorporated by reference to Exhibit 10.2 to the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2019).](https://www.sec.gov/Archives/edgar/data/879169/000155837019003610/incy-20190331ex102573f77.htm) | | |
| [removed: 10.12#] [added: 10.20#] | | | | | | [Amended and Restated Employment Agreement between the Company and Hervé Hoppenot, dated as of October 25, 2019 (incorporated by reference to Exhibit 10.3 to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, [removed: 2019).](http://www.sec.gov/Archives/edgar/data/879169/000155837019009326/incy-20190930ex10388737b.htm)] [added: 2019).](https://www.sec.gov/Archives/edgar/data/879169/000155837019009326/incy-20190930ex10388737b.htm)] | | |
| [removed: 10.13#] [added: 10.21#] | | | | | | [Offer of Employment Letter, dated April 21, 2023, from the Company to Pablo J. Cagnoni (incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2023).](https://www.sec.gov/Archives/edgar/data/879169/000087916923000025/exhibit101-cagnoniofferlet.htm) | | |
| [removed: 10.14†] [added: 10.22†] | | | | | | [Collaboration and License Agreement entered into as of November 24, 2009, by and between the Company and Novartis International Pharmaceutical Ltd. (incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, [removed: 2019).](http://www.sec.gov/Archives/edgar/data/879169/000155837019009326/incy-20190930ex101e8f74d.htm)] [added: 2019).](https://www.sec.gov/Archives/edgar/data/879169/000155837019009326/incy-20190930ex101e8f74d.htm)] | | |
| [removed: 10.14.1†] [added: 10.22.1†] | | | | | | [Amendment, dated as of April 5, 2016, to Collaboration and License Agreement entered into as of November 24, 2009, by and between the Company and Novartis International Pharmaceutical Ltd. (incorporated by reference to Exhibit 10.1.1 to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, [removed: 2019).](http://www.sec.gov/Archives/edgar/data/879169/000155837019009326/incy-20190930ex10117002c.htm)] [added: 2019).](https://www.sec.gov/Archives/edgar/data/879169/000155837019009326/incy-20190930ex10117002c.htm)] | | |
| [removed: 10.14.2††] [added: 10.22.2††] | | | | | | [Amendment, dated as of March 20, 2020, to the Collaboration and License Agreement entered into as of November 24, 2009, by and between the Company and Novartis International Pharmaceutical Ltd. (incorporated by reference to Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2020).](https://www.sec.gov/Archives/edgar/data/879169/000155837020005185/incy-20200331xex10d2.htm) | | |
| [removed: 10.15†] [added: 10.23†] | | | | | | [License, Development and Commercialization Agreement, entered into as of December 18, 2009, by and between the Company and Eli Lilly and Company (incorporated by reference to Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, [removed: 2019).](http://www.sec.gov/Archives/edgar/data/879169/000155837019009326/incy-20190930ex1020eebfd.htm)] [added: 2019).](https://www.sec.gov/Archives/edgar/data/879169/000155837019009326/incy-20190930ex1020eebfd.htm)] | | |
| [removed: 10.15.1†] [added: 10.23.1†] | | | | | | [Amendment, dated June 22, 2010, to License, Development and Commercialization Agreement entered into as of December 18, 2009, by and between the Company and Eli Lilly and Company (incorporated by reference to Exhibit 10.2.1 to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, [removed: 2019).](http://www.sec.gov/Archives/edgar/data/879169/000155837019009326/incy-20190930ex1021f3558.htm)] [added: 2019).](https://www.sec.gov/Archives/edgar/data/879169/000155837019009326/incy-20190930ex1021f3558.htm)] | | |
| [removed: 10.15.2†] [added: 10.23.2†] | | | | | | [Third Amendment, entered into effective March 31, 2016, to License, Development and Commercialization Agreement entered into as of December 18, 2009, by and between the Company and Eli Lilly and Company (incorporated by reference to Exhibit 10.2.2 to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, [removed: 2019).](http://www.sec.gov/Archives/edgar/data/879169/000155837019009326/incy-20190930ex10225e24a.htm)] [added: 2019).](https://www.sec.gov/Archives/edgar/data/879169/000155837019009326/incy-20190930ex10225e24a.htm)] | | |
| [removed: 10.15] [added: 10.23] .3† | | | | | | [Fourth Amendment, entered into effective December 13, 2016, to License, Development and Commercialization Agreement entered into as of December 18, 2009, by and between the Company and Eli Lilly and Company (incorporated by reference to Exhibit 10.21.4 to Amendment No. 2 on Form 10-K/A to the Company’s Annual Report on Form 10-K for the year ended December 31, [removed: 2016).](http://www.sec.gov/Archives/edgar/data/879169/000110465917043033/a17-15971_1ex10d21d4.htm)] [added: 2016).](https://www.sec.gov/Archives/edgar/data/879169/000110465917043033/a17-15971_1ex10d21d4.htm)] | | |
| [removed: 10.15.4††] [added: 10.23.4††] | | | | | | [Letter Agreement, dated May 13, 2020, between the Company and Eli Lilly and Company, together with related Letter of Understanding, dated March 5, 2020, between the Company and Eli Lilly and Company, each relating to License, Development and Commercialization Agreement entered into as of December 18, 2009 by and between the Company and Eli Lilly and Company (incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2020).](https://www.sec.gov/Archives/edgar/data/879169/000155837020009164/incy-20200630xex10d1.htm) | | |
| [removed: 10.17] [added: 10.24] | | | | | | [Registration Rights Agreement, dated as of February 12, 2016, between the Company and 667, L.P., Baker Brothers Life Sciences, L.P. and 14159, L.P. (incorporated by reference to Exhibit 10.28 to the Company’s Annual Report on Form 10-K for the year ended December 31, [removed: 2015).](http://www.sec.gov/Archives/edgar/data/879169/000155837016003196/incy-20151231ex10283b05a.htm)] [added: 2015).](https://www.sec.gov/Archives/edgar/data/879169/000155837016003196/incy-20151231ex10283b05a.htm)] | | |
| [removed: 10.18] [added: 10.25] | | | | | | [Revolving Credit and Guaranty Agreement, dated as of August 18, 2021, among the Company, the guarantors party thereto, the lenders party thereto, and JPMorgan Chase Bank, N.A., as Administrative Agent (incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2021).](https://www.sec.gov/Archives/edgar/data/0000879169/000155837021014131/incy-20210930xex10d1.htm) | | |
| [removed: 10.18.1] [added: 10.25.1] | | | | | | [Amendment No. 1, dated as of May 10, 2023, to Revolving Credit and Guaranty Agreement dated as of August 18, [removed: 2021 among] [added: 2021](https://www.sec.gov/Archives/edgar/data/879169/000087916923000025/exhibit103-amendedcreditag.htm)[,](https://www.sec.gov/Archives/edgar/data/879169/000087916923000025/exhibit103-amendedcreditag.htm) [among] the Company, the guarantors party thereto, the lenders party thereto, and JPMorgan Chase Bank, N.A., as Administrative Agent. (incorporated by reference to Exhibit 10.3 to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2023).](https://www.sec.gov/Archives/edgar/data/879169/000087916923000025/exhibit103-amendedcreditag.htm) | | |
| 21.1* | | | | | | [Subsidiaries of the [removed: Company.](https://www.sec.gov/Archives/edgar/data/879169/000087916924000045/exhibit211-12312023.htm)] [added: Company.](https://www.sec.gov/Archives/edgar/data/879169/000162828025004633/exhibit211-12312024.htm)] | | |
| 23.1* | | | | | | [Consent of Ernst & Young LLP, Independent Registered Public Accounting [removed: Firm.](https://www.sec.gov/Archives/edgar/data/879169/000087916924000045/exhibit231-12312023.htm)] [added: Firm.](https://www.sec.gov/Archives/edgar/data/879169/000162828025004633/exhibit231-12312024.htm)] | | |
| 31.1* | | | | | | [Rule 13a 14(a) Certification of the Chief Executive [removed: Officer.](https://www.sec.gov/Archives/edgar/data/879169/000087916924000045/exhibit311-12312023.htm)] [added: Officer.](https://www.sec.gov/Archives/edgar/data/879169/000162828025004633/exhibit311-12312024.htm)] | | |
| 31.2* | | | | | | [Rule 13a 14(a) Certification of the Chief Financial [removed: Officer.](https://www.sec.gov/Archives/edgar/data/879169/000087916924000045/exhibit312-12312023.htm)] [added: Officer.](https://www.sec.gov/Archives/edgar/data/879169/000162828025004633/exhibit312-12312024.htm)] | | |
| 32.1 | | | | | | [Statement of the Chief Executive Officer under Section 906 of the Sarbanes Oxley Act of 2002 (18 U.S.C Section [removed: 1350).](https://www.sec.gov/Archives/edgar/data/879169/000087916924000045/exhibit321-12312023.htm)] [added: 1350).](https://www.sec.gov/Archives/edgar/data/879169/000162828025004633/exhibit321-12312024.htm)] | | |
| 32.2 | | | | | | [Statement of the Chief Financial Officer under Section 906 of the Sarbanes Oxley Act of 2002 (18 U.S.C Section [removed: 1350).](https://www.sec.gov/Archives/edgar/data/879169/000087916924000045/exhibit322-12312023.htm)] [added: 1350).](https://www.sec.gov/Archives/edgar/data/879169/000162828025004633/exhibit322-12312024.htm)] | | |
| 10.7# | | | | | | [F](https://www.sec.gov/Archives/edgar/data/879169/000087916924000172/exh101_formofusexecutiveof.htm)[orm of U.S. Stock Option Agreement for Executive Officers under the Incyte Corporation Amended and Restated 2010 Stock Incentive Plan (incorporated by re](https://www.sec.gov/Archives/edgar/data/879169/000087916924000172/exh101_formofusexecutiveof.htm)[ference to Exhibit 10.1 to the Company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2024).](https://www.sec.gov/Archives/edgar/data/879169/000087916924000172/exh101_formofusexecutiveof.htm) | | |
| 10.8# | | | | | | [F](https://www.sec.gov/Archives/edgar/data/879169/000087916924000172/exh102_formofusrsuawardagr.htm)[orm of U.S. Restricted Stock Unit](https://www.sec.gov/Archives/edgar/data/879169/000087916924000172/exh102_formofusrsuawardagr.htm) [Award](https://www.sec.gov/Archives/edgar/data/879169/000087916924000172/exh102_formofusrsuawardagr.htm) [Agreement](https://www.sec.gov/Archives/edgar/data/879169/000087916924000172/exh102_formofusrsuawardagr.htm) [under the Inc](https://www.sec.gov/Archives/edgar/data/879169/000087916924000172/exh102_formofusrsuawardagr.htm)[yte Corporat](https://www.sec.gov/Archives/edgar/data/879169/000087916924000172/exh102_formofusrsuawardagr.htm)[ion Amended and Restated 2010 Stock Incentive Plan (incorporated by reference to Exhibit 10.2 to the Company's Quarterly Report on Form 10-Q for the qu](https://www.sec.gov/Archives/edgar/data/879169/000087916924000172/exh102_formofusrsuawardagr.htm)[arter ended September](https://www.sec.gov/Archives/edgar/data/879169/000087916924000172/exh102_formofusrsuawardagr.htm) [30, 2024](https://www.sec.gov/Archives/edgar/data/879169/000087916924000172/exh102_formofusrsuawardagr.htm)[).](https://www.sec.gov/Archives/edgar/data/879169/000087916924000172/exh102_formofusrsuawardagr.htm) | | |
| 10.9# | | | | | | [I](https://www.sec.gov/Archives/edgar/data/879169/000110465924020600/tm245850d1_ex99-1.htm)[ncyte Corporation 2024 Indu](https://www.sec.gov/Archives/edgar/data/879169/000110465924020600/tm245850d1_ex99-1.htm)[cement Stock Incentive Plan (incorporated by reference to Exhibit 99.1 to the Company's](https://www.sec.gov/Archives/edgar/data/879169/000110465924020600/tm245850d1_ex99-1.htm) [Registration Statement on Form S-8](https://www.sec.gov/Archives/edgar/data/879169/000110465924020600/tm245850d1_ex99-1.htm) [(File No. 333-277043).](https://www.sec.gov/Archives/edgar/data/879169/000110465924020600/tm245850d1_ex99-1.htm) | | |
| 10.10# | | | | | | [F](https://www.sec.gov/Archives/edgar/data/879169/000110465924020600/tm245850d1_ex99-2.htm)[o](https://www.sec.gov/Archives/edgar/data/879169/000110465924020600/tm245850d1_ex99-2.htm)[rm of Global Nonstatutory Stock Option Agreement for Executive Officers under the Incyte Corporation 2024 Inducement Stock Incentive Plan (incorporated by reference to](https://www.sec.gov/Archives/edgar/data/879169/000110465924020600/tm245850d1_ex99-2.htm) [Exh](https://www.sec.gov/Archives/edgar/data/879169/000110465924020600/tm245850d1_ex99-2.htm)[ibit 99.2 to the Company's Registration S](https://www.sec.gov/Archives/edgar/data/879169/000110465924020600/tm245850d1_ex99-2.htm)[tatement on Form S](https://www.sec.gov/Archives/edgar/data/879169/000110465924020600/tm245850d1_ex99-2.htm)[\-8 (File No. 333-277043](https://www.sec.gov/Archives/edgar/data/879169/000110465924020600/tm245850d1_ex99-2.htm)[).](https://www.sec.gov/Archives/edgar/data/879169/000110465924020600/tm245850d1_ex99-2.htm) | | |
| 10.11# | | | | | | [Form of Global Restricted Stock Unit Agreement under the Incyte Corporation 2024 Inducement Stock Incentive Plan (incorporated by reference to Exhibit](https://www.sec.gov/Archives/edgar/data/879169/000110465924020600/tm245850d1_ex99-3.htm) [99](https://www.sec.gov/Archives/edgar/data/879169/000110465924020600/tm245850d1_ex99-3.htm)[.3 to the Company's](https://www.sec.gov/Archives/edgar/data/879169/000110465924020600/tm245850d1_ex99-3.htm) [Registration S](https://www.sec.gov/Archives/edgar/data/879169/000110465924020600/tm245850d1_ex99-3.htm)[tatement on Form S-8 (File No. 333-277043)](https://www.sec.gov/Archives/edgar/data/879169/000110465924020600/tm245850d1_ex99-3.htm)[.](https://www.sec.gov/Archives/edgar/data/879169/000110465924020600/tm245850d1_ex99-3.htm) | | |
| 10.12# | | | | | | [F](https://www.sec.gov/Archives/edgar/data/879169/000110465924020600/tm245850d1_ex99-4.htm)[orm of Performance Share Awar](https://www.sec.gov/Archives/edgar/data/879169/000110465924020600/tm245850d1_ex99-4.htm)[d Agreement under the Incyte Corp](https://www.sec.gov/Archives/edgar/data/879169/000110465924020600/tm245850d1_ex99-4.htm)[oration 2024 Inducement Stock Incentive Plan (incorporated by reference to Exhi](https://www.sec.gov/Archives/edgar/data/879169/000110465924020600/tm245850d1_ex99-4.htm)[bit 99.4 to the Company's Registration S](https://www.sec.gov/Archives/edgar/data/879169/000110465924020600/tm245850d1_ex99-4.htm)[tatement on Form S-8 (F](https://www.sec.gov/Archives/edgar/data/879169/000110465924020600/tm245850d1_ex99-4.htm)[ile No. 333-277043).](https://www.sec.gov/Archives/edgar/data/879169/000110465924020600/tm245850d1_ex99-4.htm) | | |
| 10.13# | | | | | | [Form of U.S. Nonstatutory Stock Option Agreement for Executive Officers under the Incyte Corporation 2024 Inducement Stock Incentive Plan (incorporated by reference to Exhibit 10.3 to the Company's Quarterly Report on Form 10-Q for the quarter ended](https://www.sec.gov/Archives/edgar/data/879169/000087916924000172/exh103_usformofexecutiveof.htm) [Septe](https://www.sec.gov/Archives/edgar/data/879169/000087916924000172/exh103_usformofexecutiveof.htm)[mber](https://www.sec.gov/Archives/edgar/data/879169/000087916924000172/exh103_usformofexecutiveof.htm) [30, 2024).](https://www.sec.gov/Archives/edgar/data/879169/000087916924000172/exh103_usformofexecutiveof.htm) | | |
| 10.14# | | | | | | [F](https://www.sec.gov/Archives/edgar/data/879169/000087916924000172/exh104_usformofrsuawardagr.htm)[orm of U.S. Restricted Stock Unit Award Agreement for Executive Officers under the Incyte Corp](https://www.sec.gov/Archives/edgar/data/879169/000087916924000172/exh104_usformofrsuawardagr.htm)[oration 2024 Inducement Stock Incentive Plan (in](https://www.sec.gov/Archives/edgar/data/879169/000087916924000172/exh104_usformofrsuawardagr.htm)[corporated by reference to Exhibit 10.4 to the Company's Quarterly Report on Form 10-Q for the quarter en](https://www.sec.gov/Archives/edgar/data/879169/000087916924000172/exh104_usformofrsuawardagr.htm)[ded September 30, 2024).](https://www.sec.gov/Archives/edgar/data/879169/000087916924000172/exh104_usformofrsuawardagr.htm) | | |
| 10.25.2 | | | | | | [Amendment No. 2](https://www.sec.gov/Archives/edgar/data/879169/000087916924000149/incytecorporationexhibit101.htm)[, dated](https://www.sec.gov/Archives/edgar/data/879169/000087916924000149/incytecorporationexhibit101.htm) [as of June 28, 2024, to R](https://www.sec.gov/Archives/edgar/data/879169/000087916924000149/incytecorporationexhibit101.htm)[evolving Credit and Guar](https://www.sec.gov/Archives/edgar/data/879169/000087916924000149/incytecorporationexhibit101.htm)[anty Agreement dated as of August 18, 2021, among the Company, the guarantors party thereto, the lenders party thereto, and JPMorgan Chase Bank, N.A., as Administrative Agent](https://www.sec.gov/Archives/edgar/data/879169/000087916924000149/incytecorporationexhibit101.htm) [(in](https://www.sec.gov/Archives/edgar/data/879169/000087916924000149/incytecorporationexhibit101.htm)[corporated by reference to Exhibit 10.1 to the Company's Quart](https://www.sec.gov/Archives/edgar/data/879169/000087916924000149/incytecorporationexhibit101.htm)[erly Report on Form 10-Q for the qu](https://www.sec.gov/Archives/edgar/data/879169/000087916924000149/incytecorporationexhibit101.htm)[a](https://www.sec.gov/Archives/edgar/data/879169/000087916924000149/incytecorporationexhibit101.htm)[rter ended](https://www.sec.gov/Archives/edgar/data/879169/000087916924000149/incytecorporationexhibit101.htm) [June](https://www.sec.gov/Archives/edgar/data/879169/000087916924000149/incytecorporationexhibit101.htm) [30, 2024](https://www.sec.gov/Archives/edgar/data/879169/000087916924000149/incytecorporationexhibit101.htm)[).](https://www.sec.gov/Archives/edgar/data/879169/000087916924000149/incytecorporationexhibit101.htm) | | |
| 19.1* | | | | | | [Policy on insider trading.](https://www.sec.gov/Archives/edgar/data/879169/000162828025004633/exhibit191-incyinsidertrad.htm) | | |
| 97 | | | | | | [Incyte Corporation Policy for Recoupment of Erroneously Awarded Compensation](https://www.sec.gov/Archives/edgar/data/879169/000087916924000062/incytepolicyforrecoupmento.htm) [(inc](https://www.sec.gov/Archives/edgar/data/879169/000087916924000062/incytepolicyforrecoupmento.htm)[orporated by reference to Exhibit 97.1 to the Company's](https://www.sec.gov/Archives/edgar/data/879169/000087916924000062/incytepolicyforrecoupmento.htm) [Amended Annual Report on Form 10-K/A for the year ended December 31, 202](https://www.sec.gov/Archives/edgar/data/879169/000087916924000062/incytepolicyforrecoupmento.htm)[3](https://www.sec.gov/Archives/edgar/data/879169/000087916924000062/incytepolicyforrecoupmento.htm) [filed](https://www.sec.gov/Archives/edgar/data/879169/000087916924000062/incytepolicyforrecoupmento.htm) [February 16, 2024](https://www.sec.gov/Archives/edgar/data/879169/000087916924000062/incytepolicyforrecoupmento.htm)[)](https://www.sec.gov/Archives/edgar/data/879169/000087916924000062/incytepolicyforrecoupmento.htm)[.](https://www.sec.gov/Archives/edgar/data/879169/000087916924000062/incytepolicyforrecoupmento.htm) | | |
| | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Exhibit Number | | | | | | Description of Document | | |
| 10.16 † | | | | | | [License, Development and Commercialization Agreement, dated as of January 9, 2015, by and among the Company, Incyte Europe S.à.r.l. (a wholly owned subsidiary of the Company), Agenus Inc. and 4-Antibody AG (incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2015).](http://www.sec.gov/Archives/edgar/data/879169/000110465915032614/a15-7158_1ex10d1.htm) | | |
| 10.16.1† | | | | | | [First Amendment, dated as of February 14, 2017, to License, Development and Commercialization Agreement entered into as of January 9, 2015, by and among the Company, Incyte Europe S.à.r.l. (a wholly owned subsidiary of the Company), Agenus Inc. and Agenus Switzerland Inc. (f/k/a 4-Antibody AG) (incorporated by reference to Exhibit 10.1 to the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2017).](http://www.sec.gov/Archives/edgar/data/879169/000155837017003529/incy-20170331ex1018c8960.htm) | | |
| 97.1* | | | | | | [Incyte Corporation Policy for Recoupment of Erroneously Awarded Compensation.](https://www.sec.gov/Archives/edgar/data/879169/000087916924000045/exhibit971-revisedclawback.htm) | | |
Item 16. Form 10-K Summary.
12 rewritten, 0 added, 0 removed, 38 unchanged
Date: February [removed: 13, 2024][added: 10, 2025]
| /s/ HERVÉ HOPPENOT | | | | | | President and Chief Executive Officer (Principal Executive Officer) and Chairman of the Board | | | | | | February [removed: 13, 2024] [added: 10, 2025] | | |
| /s/ CHRISTIANA STAMOULIS | | | | | | Executive Vice President and Chief Financial Officer (Principal Financial Officer) | | | | | | February [removed: 13, 2024] [added: 10, 2025] | | |
| /s/ THOMAS TRAY | | | | | | Vice President and Chief Accounting Officer (Principal Accounting Officer) | | | | | | February [removed: 13, 2024] [added: 10, 2025] | | |
| /s/ JULIAN C. BAKER | | | | | | Director | | | | | | February [removed: 13, 2024] [added: 10, 2025] | | |
| /s/ JEAN-JACQUES BIENAIMÉ | | | | | | Director | | | | | | February [removed: 13, 2024] [added: 10, 2025] | | |
| /s/ OTIS W. BRAWLEY | | | | | | Director | | | | | | February [removed: 13, 2024] [added: 10, 2025] | | |
| /s/ PAUL J. CLANCY | | | | | | Director | | | | | | February [removed: 13, 2024] [added: 10, 2025] | | |
| /s/ JACQUALYN A. FOUSE | | | | | | Director | | | | | | February [removed: 13, 2024] [added: 10, 2025] | | |
| /s/ EDMUND P. HARRIGAN | | | | | | Director | | | | | | February [removed: 13, 2024] [added: 10, 2025] | | |
| /s/ KATHERINE A. HIGH | | | | | | Director | | | | | | February [removed: 13, 2024] [added: 10, 2025] | | |
| /s/ SUSANNE SCHAFFERT | | | | | | Director | | | | | | February [removed: 13, 2024] [added: 10, 2025] | | |