INCY 8-K Current Reports

Incyte 8-K Report, Financial Results (Oct 29, 2026)

Incyte Corporation reported third quarter 2026 results on October 29, 2026, furnished as Exhibit 99.1 to this Form 8-K. Total revenue was $1.56 billion and total net sales were $1.32 billion, each up 14% from the third quarter of 2025. Jakafi/Jakafi XR net sales were $827 million (up 4%), Opzelura net sales were $255 million (up 36%), and Hematology and Oncology net sales were $235 million (up 38%). The company raised its full-year 2026 guidance for total net sales to $5,210-$5,300 million (from $5,130-$5,260 million), Opzelura to $1,100-$1,120 million, and Hematology and Oncology to $890-$910 million. Opzelura guidance includes a one-time $246 million benefit tied to an agreement with CMS on Medicaid rebate litigation. Profitability was sharply lower due to a one-time $1.23 billion IPR&D expense from the Vega Therapeutics acquisition, which was completed in July. GAAP net loss for the quarter was $784.8 million, or $(3.86) per diluted share, compared with net income of $424.2 million, or $2.11 per diluted share, a year earlier. Non-GAAP net loss was $730.8 million, or $(3.60) per diluted share. Cash, cash equivalents and marketable securities were $3.9 billion at September 30, 2026, versus $3.6 billion at December 31, 2025. GAAP R&D expense was $1.79 billion and SG&A was $364.3 million. The release also highlighted pipeline and regulatory milestones, including a Phase 3 study (EXCALIBUR-ET2) of INCA033989 in essential thrombocythemia that was initiated in mid-2026, a potential U.S. approval and launch of Monjuvi in newly diagnosed DLBCL in the first quarter of 2027, and a U.S. NDA for povorcitinib in hidradenitis suppurativa under review with a potential launch in the first quarter of 2027. Phase 3 data for povorcitinib in prurigo nodularis and topline data from the ruxolitinib cream HS studies are expected in the fourth quarter of 2026.

Oct 29, 2026 8-K

Incyte 8-K Report, Corporate Update (Aug 31, 2026)

Incyte Corporation filed a Form 8-K on August 31, 2026 under Item 8.01 (Other Events) to disclose that it has entered into an agreement with the U.S. Centers for Medicare & Medicaid Services (CMS). The stated aim of the agreement is to improve patient access to medicines while supporting continued U.S. biopharmaceutical innovation. Under the agreement, Incyte will enable state Medicaid programs to access Jakafi and Jakafi XR at prices aligned with those in a defined group of other advanced, industrialized nations. The company also expects that it will not be subject to certain future CMS pricing mandates, including the proposed GUARD and GLOBE models. Incyte states that it does not expect the agreement to affect its 2026 financial guidance or to have a material impact on its future financial outlook.

Aug 31, 2026 8-K

Other EventsExhibits & Filings

Incyte 8-K Report, Financial Results (Jul 28, 2026)

Incyte Corporation reported financial results for its second fiscal quarter ended June 30, 2026, in a press release furnished as Exhibit 99.1 to this Form 8-K. Total revenue was $1.67 billion, up 38% from the second quarter of 2025, and total net sales were $1.49 billion, up 40%. The sales increase was boosted by a one-time, non-cash benefit of $246 million tied to the reversal of previously established Opzelura accrual balances through March 31, 2026, following an agreement with CMS. Excluding that benefit, total net sales grew 17% year over year. Jakafi net sales were $817 million (up 7%), Opzelura net sales were $450 million (up 173%, or $204 million excluding the one-time benefit, up 24%), and Hematology and Oncology portfolio net sales were $222 million (up 69%). Incyte raised its full-year 2026 total net sales guidance to $5,130-$5,260 million from $4,770-$4,940 million, and raised its Opzelura net sales guidance to $1,050-$1,100 million. Full-year GAAP R&D and SG&A operating expense guidance rose to $4,915-$4,995 million from $3,495-$3,675 million, reflecting an expected IPR&D expense of approximately $1,270 million in the third quarter of 2026 tied to the acquisition of Vega Therapeutics, plus $50 million of incremental latarcibart R&D investment. Cash, cash equivalents and marketable securities were $4.5 billion as of June 30, 2026, compared with $3.6 billion at December 31, 2025. The company also completed its acquisition of Vega Therapeutics, Inc. for $1.25 billion, adding latarcibart, a Phase 3 candidate for von Willebrand disease, and discontinued INCB160058 (JAK2V617F). The filing lists ten clinical data readouts, including four registrational trials, expected in the second half of 2026.

Jul 28, 2026 8-K

Incyte 8-K Report, Corporate Update (Jul 6, 2026)

Incyte Corporation reported in a Form 8-K dated July 6, 2026 that it has completed its previously announced acquisition of Vega Therapeutics, Inc., a wholly owned subsidiary of Star Therapeutics LLC. The acquisition adds VGA039, a novel investigational monoclonal antibody in Phase 3 development for von Willebrand disease (VWD), the most common inherited bleeding disorder, to Incyte's hematology portfolio. The company describes VGA039 as targeting Protein S to restore hemostasis, with potential to be the first once-monthly subcutaneous prophylactic therapy for VWD patients who currently require frequent intravenous infusions. Under the stock purchase agreement, Incyte acquired all outstanding shares of Vega Therapeutics for $1.25 billion upfront. Star Therapeutics is eligible to receive up to $750 million in additional payments upon the achievement of sales milestones. Incyte expects the transaction to be reflected as a one-time R&D expense in its third-quarter and full-year 2026 GAAP and non-GAAP results. VGA039 has received Breakthrough Therapy, Fast Track, orphan drug and rare pediatric disease designations from the U.S. Food and Drug Administration and has advanced into the Phase 3 VIVID-6 study, a global single-arm cross-over study of subcutaneous VGA039 prophylaxis in patients with all types of VWD.

Jul 6, 2026 8-K

Incyte 8-K Report, Corporate Update (Jun 22, 2026)

Incyte Corporation (INCY) disclosed under Item 8.01 (Other Events) that it has reached an agreement with the Centers for Medicare & Medicaid Services (CMS) to resolve its litigation over the application of Medicaid rebate rules to Opzelura (ruxolitinib) cream. Under the agreement, CMS will not apply the line extension regulation to Opzelura as if it were a line extension of Jakafi (ruxolitinib), and the company has withdrawn its lawsuit challenging the regulations. The settlement was reached based on the unique facts of Opzelura and Jakafi. As a result, the company expects to record a one-time, non-cash benefit of approximately $246 million in the second quarter ending June 30, 2026. This benefit reflects the reversal of previously established accrual balances through March 31, 2026, related to liabilities tied to the potential application of the line extension regulations to Opzelura. The company will no longer accrue for that potential application and expects an improvement to Opzelura's gross-to-net on a go-forward basis. The company plans to update its financial guidance to reflect the settlement's impact during its next scheduled earnings release.

Jun 22, 2026 8-K

Shareholder Matters

Incyte 8-K Report, Shareholder Vote Results (Jun 9, 2026)

At its Annual Meeting of Shareholders held on June 8, 2026, Incyte Corporation shareholders elected all eight director nominees: Julian C. Baker, Jean-Jacques Bienaimé, Otis W. Brawley, Paul J. Clancy, Jacqualyn A. Fouse, Edmund P. Harrigan, Katherine A. High, and William J. Meury. Each nominee received more votes For than Against, with broker non-votes of 11,426,181 recorded for every director. Shareholders also approved, on a non-binding advisory basis, the compensation of the company's named executive officers, with 145,851,784 votes For, 28,078,013 Against, 290,891 Abstain, and 11,426,181 broker non-votes. In addition, shareholders ratified the appointment of Ernst & Young LLP as the independent registered public accounting firm for the fiscal year ending December 31, 2026, with 173,072,501 votes For, 12,457,655 Against, and 116,713 Abstain. This 8-K reports only the voting results from the annual meeting under Item 5.07. It contains no financial results, guidance, or other operational disclosures.

Jun 9, 2026 8-K

Incyte 8-K Report, Corporate Update (Jun 8, 2026)

Incyte Corporation (INCY) reported in a Form 8-K dated June 8, 2026 that it has entered into a definitive agreement to acquire Vega Therapeutics, Inc., a wholly owned subsidiary of Star Therapeutics, LLC. Incyte will pay $1.25 billion upfront, and Star Therapeutics will be eligible to receive up to $750 million in additional payments upon achievement of sales milestones, for total potential consideration of up to $2.0 billion, subject to customary closing adjustments. The transaction is structured as an equity (stock purchase) acquisition. The core asset is VGA039, a novel investigational monoclonal antibody that targets Protein S and is in Phase 3 development for von Willebrand disease (VWD), described as the most common inherited bleeding disorder. The company states VGA039 has received FDA Breakthrough Therapy, Fast Track, orphan drug and rare pediatric disease designations and is being studied in the Phase 3 VIVID-6 trial. The filing states it could be the first subcutaneous prophylactic therapy with a convenient dosing regimen for VWD patients who currently require frequent intravenous infusions. The transaction is expected to close in the third quarter of 2026, subject to expiration of the Hart-Scott-Rodino waiting period and other customary conditions. Incyte expects an R&D charge of approximately $1.25 billion, to be included in third quarter and full year 2026 GAAP and non-GAAP results. Incyte's CEO Bill Meury said the deal fits the company's strategy of building a top-tier growth company and expands its hematology portfolio.

Jun 8, 2026 8-K

Earnings & Results

Incyte 8-K Report, Financial Results (Apr 28, 2026)

Incyte Corporation reported financial results for its first fiscal quarter ended March 31, 2026, in a press release furnished as Exhibit 99.1 to this Form 8-K. Total GAAP revenues were $1.27 billion, up 21% from the first quarter of 2025, and total net sales were $1.10 billion, up 20%. GAAP net income was $303.3 million ($1.47 diluted EPS) versus $158.2 million ($0.80 diluted EPS) a year earlier, and non-GAAP diluted EPS was $1.81 versus $1.16. Growth was driven by Jakafi net sales of $758 million (up 7%), Opzelura net sales of $143 million (up 20%), and hematology and oncology net sales of $204 million (up 116%), which includes Niktimvo, Monjuvi/Minjuvi and Zynyz. Cash, cash equivalents and marketable securities rose to $4.0 billion at March 31, 2026, from $3.6 billion at December 31, 2025. Cost and expense growth was notable: GAAP cost of sales rose 43% and GAAP R&D rose 18%, while GAAP SG&A was roughly flat at up 1%. The quarter also included $23.2 million of asset impairment and disposal costs tied to the sale of Incyte's downtown Wilmington, Delaware properties. Incyte reaffirmed all 2026 guidance, including total net sales of $4,770 to $4,940 million and total non-GAAP R&D and SG&A operating expenses of $3,205 to $3,375 million. The release also covered pipeline progress, including positive Phase 3 results for povorcitinib in nonsegmental vitiligo, an NDA acceptance for povorcitinib in hidradenitis suppurativa, and the initiation of a Phase 3 trial of INCB161734 in first-line pancreatic ductal adenocarcinoma. Management also announced that Suketu (Suky) Upadhyay will become Chief Financial Officer effective May 4, 2026.

Apr 28, 2026 8-K

Leadership ChangesExhibits & Filings

Incyte 8-K Report, Executive Changes (Mar 30, 2026)

Incyte Corporation disclosed in this Form 8-K, filed March 30, 2026, that Susanne Schaffert has resigned from the Company's Board of Directors, effective April 15, 2026. Dr. Schaffert notified the Company of her resignation on March 26, 2026. She had served on the Board since 2022. The filing states that the resignation was not the result of any disagreement with the Company on matters relating to its operations, policies or practices. The Board thanked Dr. Schaffert for her counsel and contributions during her service. The filing contains no financial results, guidance, or other operating information. Its substance is limited to this board departure, which is disclosed under Item 5.02 of Form 8-K.

Mar 30, 2026 8-K

Incyte 8-K Report, Executive Changes (Mar 26, 2026)

Incyte Corporation filed this Current Report on Form 8-K on March 26, 2026 to disclose executive title changes announced March 25, 2026, effective immediately. Pablo J. Cagnoni's title changed to President, Incyte and Global Head of Research and Development, replacing William J. Meury as President; Meury remains Chief Executive Officer and a member of the Board of Directors. Steven H. Stein became Executive Vice President, Chief Medical Officer and Head of Late-stage Development, and Mohamed Issa became Executive Vice President and Head of U.S. Commercial, with expanded responsibility for U.S. Immunology as the U.S. Oncology and Immunology business units are integrated into a single U.S. commercial organization. The filing states there were no changes to the compensation arrangements of any of the affected executives in connection with these title changes. The press release also states that Matteo Trotta, Executive Vice President and General Manager, U.S. Dermatology, will leave Incyte following a transition period. The announcement is framed around supporting the company's strategic focus, long-term growth plans, and launch execution. The filing cites R&D progress under Dr. Cagnoni's leadership, including the mutCALR antibody, povorcitinib, CDK2, KRASG12D and TGFßR2xPD1 programs, and states that the U.S. commercial integration is intended to drive effective launch execution.

Mar 26, 2026 8-K

Incyte 8-K Report, Corporate Update (Mar 6, 2026)

Incyte Corporation disclosed in this Form 8-K, filed March 6, 2026, that the U.S. Food and Drug Administration issued a Complete Response Letter on February 27, 2026 for the supplemental Biologics License Application for Zynyz (retifanlimab-dlwr) 375mg. The sBLA sought an additional indication for adult patients with metastatic non-small cell lung cancer in combination with platinum-based chemotherapy, and was supported by positive efficacy and safety data from the Phase 3 POD1UM-304 trial announced in December 2024. The CRL cited inspection findings, which the filing states were not specific to Zynyz, at Catalent Indiana, LLC, part of Novo Nordisk, the third-party fill-finish facility referenced in the sBLA. The filing states that regulatory compliance of Catalent Indiana was the sole approvability issue cited, and that the letter did not raise other approvability concerns, including the Zynyz efficacy and safety data in NSCLC or the third-party drug substance manufacturer. Incyte says it is working closely with the FDA and Catalent Indiana to address the CRL and support a potential sBLA resubmission of Zynyz in NSCLC. The filing does not provide a timeline for resubmission.

Mar 6, 2026 8-K

Incyte 8-K Report, Financial Results (Feb 10, 2026)

Incyte Corporation filed this Form 8-K on February 10, 2026 to furnish Exhibit 99.1, a press release announcing financial results for the fourth quarter and full year ended December 31, 2025, and providing full year 2026 guidance. Total revenue was $1.51 billion for the fourth quarter (up 28% year over year) and $5.14 billion for the full year (up 21%). Total net product revenue was $1.22 billion in the fourth quarter (up 20%) and $4.35 billion for the full year (up 20%), exceeding the full year 2025 net product revenue guidance of $4.23 - $4.32 billion. GAAP net income for the full year 2025 was $1.29 billion, or $6.41 per diluted share, compared with $32.6 million, or $0.15 per diluted share, in 2024; the 2024 figure reflected $679.4 million of expense for IPR&D assets acquired in the Escient acquisition. Cash, cash equivalents and marketable securities were $3.6 billion at December 31, 2025, compared with $2.2 billion a year earlier. For 2026, the company guided total net product revenue to $4.77 - $4.94 billion, comprising Jakafi of $3.22 - $3.27 billion (including the initial launch of Jakafi XR, if approved), Opzelura of $750 - $790 million, and Hematology and Oncology products of $800 - $880 million. Total GAAP R&D and SG&A operating expense guidance is $3.495 - $3.675 billion. The company expects a regulatory decision and potential launch of Jakafi XR in mid-2026, and plans to initiate registrational programs for INCA033989 in essential thrombocythemia in mid-2026 and in myelofibrosis in the second half of 2026. The filing also notes a $242.2 million contract dispute settlement gain with Novartis and a $76.3 million asset impairment charge related to downtown Wilmington, Delaware properties in the fourth quarter. Pipeline updates include positive topline Phase 3 frontMIND results for tafasitamab in first-line DLBCL, with an sBLA planned for the first half of 2026; a povorcitinib NDA submission for hidradenitis suppurativa with FDA acceptance anticipated in the first quarter of 2026; and the decision to pause ruxolitinib cream development in prurigo nodularis after FDA feedback requiring an additional study.

Feb 10, 2026 8-K

Incyte 8-K Report, Executive Changes (Dec 12, 2025)

Incyte Corporation (INCY) filed a Form 8-K dated December 12, 2025, reporting an event of December 10, 2025. The filing is a limited governance disclosure under Item 5.02 and contains no financial results, guidance, or transaction terms. The sole reported event is the retirement of Hervé Hoppenot from the Company's Board of Directors, effective immediately, as notified to the Company on December 10, 2025. Mr. Hoppenot is described as the former Chairman and Chief Executive Officer of the Company and has served on the Board since 2014. For investors, the filing signals a board change rather than an operational or financial development. The filing does not state a successor, any committee changes, or the reasons for the retirement.

Dec 12, 2025 8-K

Incyte 8-K Report, Financial Results (Oct 28, 2025)

Incyte Corporation reported third-quarter 2025 financial results for the period ended September 30, 2025, with total GAAP revenues of $1.37 billion, up 20% from the third quarter of 2024. Total net product revenues were $1.15 billion, an increase of 19%, driven primarily by patient demand for Jakafi across all indications and strong uptake of the initial launch of Niktimvo. Jakafi net product revenue was $791 million (up 7%), Opzelura net product revenue was $188 million (up 35%), and Niktimvo net revenue was $46 million. GAAP operating income was $443.5 million versus $146.1 million a year earlier, and GAAP net income was $424.2 million, or $2.11 per diluted share, compared with $0.54 per diluted share in the prior-year quarter. Cash, cash equivalents and marketable securities totaled $2.9 billion at September 30, 2025. Incyte raised its full-year 2025 net product revenue guidance to $4.23 to $4.32 billion, with Jakafi guidance raised to $3.050 to $3.075 billion and other hematology and oncology products raised to $550 to $575 million. Opzelura guidance of $630 to $670 million was maintained, and GAAP and non-GAAP cost of product revenues, R&D and SG&A expense guidance was reiterated. The company also said it is pausing development of the INCA034460 (anti-CD122) and INCB57643 (BET inhibitor) programs and povorcitinib in chronic spontaneous urticaria as part of ongoing pipeline prioritization. The quarter also included regulatory and pipeline updates: FDA approval of the Opzelura sNDA for pediatric atopic dermatitis in September, EU and U.S. regulatory submissions for povorcitinib in hidradenitis suppurativa anticipated by year-end 2025 and early 2026, and plans to start a registrational program for INCA33890 in microsatellite stable colorectal cancer in 2026. Incyte also announced a strategic partnership with Enable Injections for the enFuse on-body delivery system to be used with INCA033989.

Oct 28, 2025 8-K

Incyte 8-K Report, Executive Changes (Oct 3, 2025)

Incyte Corporation (INCY) filed a Form 8-K on October 3, 2025 under Item 5.02 (Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers). The filing reports that on September 30, 2025, the Board of Directors appointed Thomas Tray, the Company's Vice President, Finance and Chief Accounting Officer (principal accounting officer), to the additional position of principal financial officer, effective as of September 16, 2025. Mr. Tray, age 48, joined Incyte in June 2005 as Manager, External Reporting, and has since held roles of increasing responsibility, most recently as Vice President and Controller before his current role. He holds a B.S. in Accounting from Mount Saint Mary's University and an Executive MBA in Pharmaceutical Marketing from Saint Joseph's University. The filing states that there are no arrangements or understandings between Mr. Tray and any other persons pursuant to which he was appointed as principal financial officer, that he has no family relationships with the Company's directors or executive officers, and that he has no direct or indirect material interest in any transaction requiring disclosure under Item 404(a) of Regulation S-K. The filing contains no compensation terms for the appointment.

Oct 3, 2025 8-K

Incyte 8-K Report, Executive Changes (Aug 7, 2025)

Incyte Corporation filed this Form 8-K dated August 4, 2025 (filed August 7, 2025) to report a leadership change in its finance function. On August 4, 2025, Christiana Stamoulis, Executive Vice President and Chief Financial Officer, notified the company of her intent to step down to pursue another opportunity. Her departure is effective September 16, 2025, and she will remain with the company until then to support a smooth transition. The filing states that the company has begun the process of identifying and appointing a successor for the CFO role. No replacement has been named in this report, and the filing does not discuss the reasons for the change beyond the stated pursuit of another opportunity, nor does it include any financial results or guidance. For investors, the key takeaway is a planned CFO transition with a roughly six-week runway before the effective date, during which the outgoing CFO is staying on to ensure continuity. Investors should watch for a subsequent announcement naming the successor, which the filing indicates is in process.

Aug 7, 2025 8-K

Leadership ChangesExhibits & Filings

Incyte 8-K Report, Financial Results (Jul 29, 2025)

Incyte Corporation reported second-quarter 2025 results on July 29, 2025, per a press release furnished as Exhibit 99.1. Total GAAP revenues were $1,215,529 thousand ($1.22 billion) for Q2 2025, compared with $1,043,759 thousand in Q2 2024, and GAAP net income was $404,999 thousand, or $2.04 per diluted share, versus a net loss of $444,601 thousand in the prior-year quarter. The quarter was helped by a $242.3 million benefit from a contract dispute settlement with Novartis, which reduced the Jakafi royalty rate by 50% beginning January 1, 2025 and resulted in a $280.0 million payment for royalties through December 31, 2024. Prior-year results included $691.9 million of R&D expense tied to the Escient acquisition, so year-over-year comparisons are distorted. Product revenue drivers were strong. Jakafi net product revenues were $764 million (+8% Y/Y), Opzelura was $164 million (+35% Y/Y), and Niktimvo, launched in the first quarter of 2025, generated $36 million. Incyte raised its full-year 2025 Jakafi revenue guidance to $3,000–$3,050 million and its other oncology product guidance to $500–$520 million. Cash, cash equivalents and marketable securities were $2.4 billion at June 30, 2025, and Bill Meury became President and CEO effective June 26, 2025. The filing highlights several regulatory and clinical catalysts for the second half of 2025, including Phase 3 tafasitamab data in first-line DLBCL, Phase 1 proof-of-concept data for INCA033989 in myelofibrosis, and a September 19, 2025 PDUFA date for the pediatric Opzelura sNDA after a three-month extension. Zynyz and Monjuvi received FDA approvals in May and June 2025.

Jul 29, 2025 8-K

Incyte 8-K Report, Executive Changes (Jun 27, 2025)

On June 26, 2025, Incyte Corporation announced that Hervé Hoppenot retired as President and Chief Executive Officer effective that day. He will continue as a member of the Board of Directors and, under a Transition Agreement dated June 26, 2025, will serve as special advisor to the CEO for the first anniversary of the Effective Date, followed by one year as a non-employee consultant. Julian C. Baker, Lead Independent Director, assumed the role of Chairman of the Board effective June 26, 2025. The Company also announced that William J. Meury was appointed President and Chief Executive Officer and to the Board, effective June 26, 2025. Mr. Meury previously served as President and CEO of Anthos Therapeutics, Inc. (April 2024 until its acquisition by Novartis in April 2025) and as President and CEO of Karuna Therapeutics, Inc. (January 2023 through March 2024). His offer letter provides an initial annual base salary of $1,250,000, a bonus funding target of 100% of base salary, and a sign-on performance share award with a target of 125,000 shares that can be earned at 0-400% of target based on stock price performance. The filing also discloses that the Board increased the shares authorized under the 2024 Inducement Stock Incentive Plan from 1,000,000 to 2,000,000 and removed the 2.0-for-1 share counting provision for full-value awards. Severance terms for Mr. Meury include 1.5 times base salary plus target bonus outside a change in control and 2 times that amount within the 24-month change in control period.

Jun 27, 2025 8-K

Leadership ChangesShareholder MattersExhibits & Filings

Incyte 8-K Report, Executive Changes (Jun 11, 2025)

Incyte Corporation (INCY) filed this Form 8-K on June 11, 2025 to report the results of its Annual Meeting of Stockholders held on June 10, 2025. At the meeting, stockholders approved an amendment to the Amended and Restated 2010 Stock Incentive Plan (the "SIP") that increases the shares available for issuance by 8,500,000, from 66,453,475 to 74,953,475 shares, removes the fungible share ratio for future awards, and extends the SIP's termination date by five years. Stockholders also approved a 1,000,000-share increase in the 1997 Employee Stock Purchase Plan (the "ESPP"), from 10,350,000 to 11,350,000 shares reserved for issuance. All nine director nominees were elected. Stockholders approved the non-binding advisory vote on named executive officer compensation, with 153,838,972 votes for and 13,020,842 against. The SIP amendment received 119,037,652 votes for and 48,330,806 against, and the ESPP amendment received 166,487,048 votes for and 873,724 against. Stockholders also ratified Ernst & Young LLP as the independent registered public accounting firm for fiscal year 2025, with 166,830,874 votes for and 10,085,753 against. For investors, the filing's main substantive item is the expanded equity capacity under the SIP and ESPP, which increases potential future dilution. The SIP vote drew a notably higher level of opposition than the other proposals, with about 48.3 million votes against. The amended plans are attached as Exhibits 10.1 and 10.2.

Jun 11, 2025 8-K

Incyte 8-K Report, Corporate Update (May 14, 2025)

On May 11, 2025, Incyte Corporation entered into a settlement agreement with Novartis Pharma AG resolving litigation Novartis initiated over the duration of royalty payments Incyte owes under their Collaboration and License Agreement dated November 24, 2009, as amended. As of March 31, 2025, Incyte had approximately $537.1 million of accrued royalties related to the dispute, included in accrued and other current liabilities on its condensed consolidated balance sheet. Under the settlement, Incyte agreed to pay Novartis $280.0 million to resolve disputed royalties on U.S. net sales of JAKAFI through December 31, 2024. The parties also agreed to reduce by 50% the royalty rate on future U.S. JAKAFI net sales beginning January 1, 2025, for a period defined in the settlement agreement. The reduced royalty for the quarter ended March 31, 2025 is approximately $14.9 million. The filing states that the $242.2 million difference between the total accrued royalties and the amount to be paid to Novartis will be recorded in Incyte's condensed consolidated statement of operations for the quarter ending June 30, 2025. This recognition is a one-time item in the second quarter of 2025 that investors should weigh when assessing near-term reported results.

May 14, 2025 8-K

Incyte 8-K Report, Financial Results (Apr 29, 2025)

Incyte Corporation reported first-quarter 2025 financial results on April 29, 2025, with total GAAP revenues of $1,052.9 million, up 20% year over year from $880.9 million. Total net product revenues were $922.3 million, up 26%, led by Jakafi at $709.4 million (up 24%) and Opzelura at $118.7 million (up 38%). Niktimvo, in its first two months of U.S. launch, generated $13.6 million in net product revenues. GAAP operating income rose to $205.2 million from $91.9 million, while GAAP net income was $158.2 million compared with $169.5 million in the prior-year quarter. GAAP diluted EPS was $0.80 versus $0.75, and non-GAAP diluted EPS was $1.16 versus $0.58. Cash, cash equivalents and marketable securities totaled $2.4 billion at March 31, 2025, up from $2.2 billion at December 31, 2024. Incyte raised its full-year 2025 Jakafi net product revenue guidance to $2,950 to $3,000 million from $2,925 to $2,975 million. Other 2025 guidance items were unchanged, including Opzelura net product revenues of $630 to $670 million and GAAP research and development expenses of $1,930 to $1,960 million. The company cited a paid demand increase of 10% for Jakafi and a 7% favorable impact from less de-stocking compared with the first quarter of 2024. On the pipeline, Incyte reported positive Phase 3 results for povorcitinib in hidradenitis suppurativa, with both STOP-HS1 and STOP-HS2 meeting their primary endpoint, and positive Phase 2 topline results in chronic spontaneous urticaria. The Phase 3 TRuE-PN2 study of ruxolitinib cream in prurigo nodularis did not reach statistical significance on its primary endpoint, while TRuE-PN1 met its primary endpoint. The company stated that Jakafi and Opzelura inventory levels were within normal range at quarter end.

Apr 29, 2025 8-K

Incyte 8-K Report, Financial Results (Feb 10, 2025)

Incyte Corporation furnished a Form 8-K on February 10, 2025 reporting its fourth-quarter and full-year 2024 financial results via Exhibit 99.1, a press release that also provides full-year 2025 financial guidance. Total GAAP revenues were $1,178,698 thousand for the fourth quarter of 2024, up 16% year over year, and $4,241,217 thousand for the full year, up 15%. Net product revenues were led by Jakafi at $773,114 thousand in the quarter (up 11%) and $2,792,107 thousand for the year (up 8%), and Opzelura at $161,602 thousand in the quarter (up 48%) and $508,293 thousand for the year (up 50%). Full-year 2024 GAAP net income fell to $32,615 thousand from $597,599 thousand in 2023, reflecting $679.4 million of expense for IPR&D assets acquired in the Escient acquisition and a $100.0 million milestone payment to MacroGenics. Non-GAAP net income was $227,591 thousand for 2024 versus $795,449 thousand in 2023. For 2025, guidance calls for Jakafi net product revenues of $2,925 to $2,975 million and Opzelura net product revenues of $630 to $670 million, with GAAP R&D expenses of $1,930 to $1,960 million. Management describes 2025 as a year of defining catalysts, including four product launches, four pivotal readouts, at least three Phase 3 study initiations and seven proof-of-concept readouts. Cash, cash equivalents and marketable securities fell to $2.2 billion at year-end 2024 from $3.7 billion, driven mainly by a $2.0 billion share repurchase in June 2024 and $783 million paid to Escient shareholders.

Feb 10, 2025 8-K

Incyte 8-K Report, Executive Changes (Jan 10, 2025)

Incyte Corporation filed this Form 8-K dated January 6, 2025 (filed January 10, 2025) to report an executive leadership change. The filing discloses that Barry P. Flannelly, Executive Vice President, General Manager, North America, announced his retirement on January 6, 2025 and stepped down from that role on that date, effective with the commencement of employment of his successor. Dr. Flannelly will remain employed by the Company through July 31, 2025 to assist with the transition of his responsibilities. The filing does not name a successor or disclose financial results, guidance, or other operational metrics. The filing is limited to Item 5.02 (Departure of Directors or Certain Officers; Compensatory Arrangements of Certain Officers). For investors, the item signals a senior commercial leadership transition in North America, with a transition period running through July 31, 2025.

Jan 10, 2025 8-K

Incyte 8-K Report, Financial Results (Oct 29, 2024)

Incyte Corporation reported third quarter 2024 results on October 29, 2024, furnishing a press release (Exhibit 99.1) that announces financial results for the quarter ended September 30, 2024. Total GAAP revenues were $1,137.9 million in Q3'24, up 24% year over year, led by Jakafi net product revenues of $741.2 million (up 16%) and Opzelura net product revenues of $139.3 million (up 52%). Management raised full-year 2024 Jakafi net product revenue guidance to $2,740 - $2,770 million from $2,710 - $2,750 million, and lowered Other Hematology/Oncology net product revenue guidance to $310 - $320 million from $325 - $360 million. Profitability was pressured by a $100.0 million milestone payment to MacroGenics in the third quarter and, for the nine months, $679.4 million of in-process R&D expense tied to the Escient acquisition. GAAP net income was $106.5 million for the quarter (GAAP diluted EPS $0.54), compared with $171.3 million a year earlier, and GAAP net loss was $168.6 million for the nine months. Full-year 2024 GAAP research and development guidance was raised to $2,545 - $2,590 million, including $791 million of one-time expenses related to Escient and MacroGenics. Cash, cash equivalents and marketable securities fell to $1.8 billion at September 30, 2024 from $3.7 billion at December 31, 2023, driven mainly by a $2.0 billion share repurchase completed in June 2024 and $783 million of cash consideration paid to Escient shareholders. On the pipeline, the company reported that Niktimvo (axatilimab-csfr) received FDA approval for chronic graft-versus-host disease, a sBLA for retifanlimab in squamous cell anal carcinoma is planned by year-end 2024, and a sNDA for ruxolitinib cream in pediatric atopic dermatitis was filed in October with approval anticipated in the second half of 2025. Management stated it is on track to achieve over ten impactful launches by 2030.

Oct 29, 2024 8-K

Material AgreementsFinancial Events

Incyte 8-K Report, Financial Results (Jul 30, 2024)

Incyte Corporation furnished a press release (Exhibit 99.1) reporting second-quarter 2024 results. Total revenues were $1,044 million, up 9% year over year, led by Jakafi net product revenues of $706 million (up 3%) and Opzelura net product revenues of $122 million (up 52%). The company reported a GAAP net loss of $444.6 million, or $(2.04) per diluted share, versus net income of $203.5 million a year earlier. The loss was driven primarily by $679.4 million of in-process R&D expense from the Escient Pharmaceuticals acquisition, plus $12.5 million of related R&D compensation and $21.5 million of related SG&A compensation. Non-GAAP net loss was $396.1 million, or $(1.82) per diluted share. Incyte completed a $2.0 billion share repurchase in June 2024, buying about 33.3 million shares at $60.00 per share, or 14.8% of shares outstanding at the time. Cash, cash equivalents and marketable securities fell to $1.4 billion at June 30, 2024 from $3.7 billion at December 31, 2023, reflecting the repurchase and $783 million of cash paid to Escient shareholders. Stockholders' equity was $2,997 million at quarter end. Incyte announced a strategic review of its pipeline with greater focus on high-impact programs, and will discontinue development of its oral small-molecule PD-L1 inhibitors, LAG-3 and TIM-3 antibodies, and the LAG-3xPD-1 bispecific. Full-year 2024 guidance for Jakafi net product revenues was raised at the low end to $2,710-$2,750 million, while GAAP R&D expense guidance was increased to $1,755-$1,800 million from $1,720-$1,760 million.

Jul 30, 2024 8-K

Incyte 8-K Report, Material Agreement (Jul 3, 2024)

Incyte Corporation entered into Amendment No. 2 to its Revolving Credit and Guaranty Agreement on June 28, 2024, with its subsidiary Incyte Holdings Corporation as guarantor and J.P. Morgan Chase Bank, N.A. as administrative agent. The amendment extends the maturity date of the revolving credit facility from August 18, 2024 to June 28, 2027. The filing states that the original agreement was dated August 21, 2021 and was previously amended by Amendment No. 1. The 8-K reports the entry into a material definitive agreement and the creation of a direct financial obligation (Items 1.01 and 2.03). The filing does not state the facility size, interest rate, or other economic terms of the amended agreement. It says a copy of Amendment No. 2, including a full copy of the Amended Credit Agreement, will be filed as an exhibit to the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2024. For investors, the principal change is a roughly three-year extension of the company's committed revolving credit liquidity, pushing the maturity well beyond the prior August 2024 date. Investors seeking pricing, covenants, or borrowing capacity will need to review the full agreement in the forthcoming 10-Q exhibit.

Jul 3, 2024 8-K

Shareholder MattersExhibits & Filings

Incyte 8-K Report, Shareholder Vote Results (Jun 14, 2024)

Incyte Corporation's Form 8-K, filed June 14, 2024, reports the results of the Company's Annual Meeting of Stockholders held June 12, 2024. Stockholders elected all nine nominated directors: Julian C. Baker, Jean-Jacques Bienaimé, Otis W. Brawley, Paul J. Clancy, Jacqualyn A. Fouse, Edmund P. Harrigan, Katherine A. High, Hervé Hoppenot, and Susanne Schaffert. Each director received more For votes than Against votes, though the margins varied; Hervé Hoppenot had the most Against votes among the nominees at 13,052,292, and Otis W. Brawley had the fewest at 1,561,259. Stockholders also approved, on a non-binding advisory basis, the compensation of the Company's named executive officers, with 171,688,040 votes For, 19,939,207 Against, 336,172 Abstain, and 11,059,781 Broker Non-Votes. Stockholders additionally ratified the appointment of Ernst & Young LLP as the independent registered public accounting firm for fiscal year 2024, with 186,582,934 For, 15,526,936 Against, and 913,330 Abstain. The filing contains no financial statements; its only exhibit is the Cover Page Interactive Data File (Exhibit 104), embedded within the Inline XBRL document. For investors, the filing confirms board continuity and shareholder support for executive pay and the auditor, while the Against vote on the say-on-pay proposal (19,939,207) is the largest opposition figure on a non-director item.

Jun 14, 2024 8-K

Material AgreementsRegulation FDExhibits & Filings

Incyte 8-K Report, Material Agreement (May 13, 2024)

On May 13, 2024, Incyte Corporation announced it is commencing a modified "Dutch Auction" tender offer to repurchase up to $1.672 billion of its common stock, at a price not greater than $60.00 and not less than $52.00 per share. The offer expires at midnight New York City time on June 10, 2024, unless extended. The Company's Board approved a share repurchase authorization of $2.0 billion. The tender offer is not conditioned on any minimum number of shares tendered and is not subject to a financing condition, though it is subject to other conditions described in the tender offer documents. Concurrently, on May 12, 2024, Incyte entered into a stock purchase agreement with Julian C. Baker, a member of the Board of Directors, Felix J. Baker, and affiliated entities including funds advised by Baker Bros. Advisors LP (the "Baker Entities"). The Baker Entities, who own 36,833,933 shares, or approximately 16.4% of outstanding shares as of May 9, 2024, agreed not to tender shares in the offer and instead to sell shares back to the Company after the offer so their ownership stays substantially at current levels. That purchase is expected to be approximately $328.0 million if the offer is fully subscribed, and it is priced at the same per-share price paid in the offer. The Audit and Finance Committee approved the agreement. If the offer is fully subscribed, the Company would repurchase a total of approximately $2.0 billion of stock through the tender offer and the Baker Entities purchase, representing approximately 14.8% to 17.1% of outstanding shares as of May 9, 2024, depending on the final price. The Company said it sees the current valuation as attractive and that it intends to preserve flexibility for strategic acquisitions. The May 10, 2024 Nasdaq closing price was $53.06 per share.

May 13, 2024 8-K

Incyte 8-K Report, Financial Results (Apr 30, 2024)

Incyte Corporation reported financial results for its first fiscal quarter ended March 31, 2024 in a press release furnished as Exhibit 99.1 to this Form 8-K. Total GAAP revenues were $880.9 million, compared with $808.7 million in the prior-year quarter (+9% Y/Y). Product revenues, net were $729.9 million, and product royalty revenues were $126.0 million. Jakafi net product revenues were $571.8 million (-1% Y/Y), with total paid patients up 5% Y/Y. Opzelura net product revenues were $85.7 million (+52% Y/Y), driven by atopic dermatitis and vitiligo uptake. GAAP net income was $169.5 million, or $0.75 per diluted share, compared with $21.7 million, or $0.10 per diluted share, a year earlier. Non-GAAP net income was $145.3 million, or $0.64 per diluted share. The company reiterated its full-year 2024 guidance, including Jakafi net product revenues of $2,690 to $2,750 million and GAAP research and development expenses of $1,720 to $1,760 million. Guidance excludes the impact of the pending acquisition of Escient Pharmaceuticals, which Incyte agreed to acquire for $750 million plus Escient's net cash at closing, subject to Hart-Scott-Rodino clearance and other customary conditions. Cash, cash equivalents and marketable securities were $3.85 billion as of March 31, 2024, up from $3.66 billion at December 31, 2023. The release also highlighted pipeline progress, including FDA Priority Review acceptance of the axatilimab BLA for chronic graft-versus-host disease, the exclusive global rights to tafasitamab acquired from MorphoSys, and a Phase 3 study of povorcitinib planned in prurigo nodularis.

Apr 30, 2024 8-K

Incyte 8-K Report, Financial Results (Feb 13, 2024)

Incyte Corporation reported its fourth quarter and full-year 2023 financial results on February 13, 2024, as furnished in Exhibit 99.1, a press release. For the full year 2023, total GAAP revenues were $3,695,649 thousand ($3.7 billion), up from $3,394,635 thousand in 2022, and total net product and royalty revenues were $3.7 billion, increasing 14% year over year. Net product revenues were $3,165,168 thousand, up 15%. Jakafi net product revenues were $2,593,732 thousand for 2023 (up 8%), and Opzelura net product revenues were $337,864 thousand (up 162%). Fourth-quarter total GAAP revenues were $1,013,341 thousand, the first quarter the company surpassed $1 billion in total revenues, according to management. GAAP net income for the full year was $597,599 thousand, or $2.65 per diluted share, compared with $340,660 thousand, or $1.52 per diluted share, in 2022. The company issued 2024 guidance, including Jakafi net product revenues of $2,690 to $2,750 million and GAAP research and development expenses of $1,720 to $1,760 million. Guidance excludes revenue from potential new product launches and the impact of the $25 million tafasitamab purchase price. Cash, cash equivalents and marketable securities totaled $3.7 billion at December 31, 2023, compared with $3.2 billion a year earlier. The release also covers pipeline updates, including a Phase 2 hidradenitis suppurativa result for ruxolitinib cream, a BLA submission for axatilimab in chronic graft-versus-host disease with approval anticipated in the second half of 2024, and FDA agreement on a path forward for once-daily ruxolitinib XR, with potential approval anticipated in approximately two years.

Feb 13, 2024 8-K

Incyte 8-K Report, Financial Results (Oct 31, 2023)

Incyte Corporation reported third-quarter 2023 results for the period ended September 30, 2023, with total GAAP revenues of $919 million, up 12% year over year. Net product revenues were $783.2 million, up 10%, and total product and royalty revenues rose 11%. GAAP net income was $171.3 million, or $0.76 per diluted share, compared with $112.8 million, or $0.50 per diluted share, in the prior-year quarter. Non-GAAP diluted EPS was $1.10. GAAP operating income increased 55% year over year. Cash, cash equivalents and marketable securities totaled $3.5 billion at September 30, 2023. Jakafi net product revenues were $636 million in the quarter, up 3%, and $1.9 billion year to date, up 8%. Incyte tightened its full-year 2023 Jakafi revenue guidance to $2.59 to $2.62 billion from $2.58 to $2.63 billion. Opzelura cream net product revenues reached $92 million in the quarter, up 141%, driven by patient demand, refills and expanded payer coverage. Opzelura will become a Preferred Brand on the CVS Caremark and Aetna formularies beginning January 1, 2024, affecting roughly 30 million commercial lives in the U.S. On the pipeline, a Phase 2 study of povorcitinib in prurigo nodularis met its primary endpoint, and a Phase 3 study is being planned, with plans underway to initiate it in 2024. The company also announced a new JAK2V617F-targeting program, INCB100658, with an IND expected by year-end 2023, and reported ongoing Phase 1 work on INCA033989 (mCALR). Other guidance items were unchanged.

Oct 31, 2023 8-K

Incyte 8-K Report, Executive Changes (Sep 12, 2023)

Incyte Corporation filed this Current Report on Form 8-K on September 12, 2023 under Item 5.02, which covers departures of directors or certain officers and compensatory arrangements. The filing reports that Maria E. Pasquale, Executive Vice President, General Counsel and Corporate Secretary, notified the Company on September 8, 2023 of her intention to retire effective November 1, 2023. The filing states that Ms. Pasquale's roles may end earlier than her retirement date if a successor is appointed to and assumes those roles before then. In that case, she will remain employed through her retirement date to assist with the transition of her responsibilities. The filing does not name a successor. The report was signed by Christiana Stamoulis, Executive Vice President and Chief Financial Officer. The filing contains no financial results or other financial figures.

Sep 12, 2023 8-K

Leadership ChangesShareholder MattersExhibits & Filings

Incyte 8-K Report, Financial Results (Aug 1, 2023)

Incyte Corporation reported financial results for its second fiscal quarter ended June 30, 2023, in a press release furnished as Exhibit 99.1 to this Form 8-K. Total GAAP revenues were $954.6 million for the quarter, compared with $911.4 million a year earlier, and GAAP net income was $203.5 million, or $0.90 per diluted share. Total net product revenues were $827.0 million, up 25% year over year, led by Jakafi at $682.4 million (up 14%) and Opzelura at $80.2 million (up 384%). Jakafi channel inventory returned to normal levels at the end of the quarter. Incyte raised the bottom end of its full-year 2023 Jakafi net product revenue guidance to a range of $2.58 to $2.63 billion, from $2.55 to $2.63 billion. Other guidance items, including GAAP research and development expenses of $1,610 to $1,650 million and GAAP SG&A expenses of $1,050 to $1,150 million, were unchanged. Cash, cash equivalents and marketable securities totaled $3.4 billion at June 30, 2023, up from $3.2 billion at December 31, 2022. On the pipeline, the Phase 2 AGAVE-201 trial of axatilimab in chronic GVHD met its primary endpoint with a 74% overall response rate at the 0.3 mg/kg dose, and the Phase 3 TRuE-AD3 trial of ruxolitinib cream in pediatric atopic dermatitis met its primary endpoint. The company also announced the departure of Chief Scientific Officer Dashyant Dhanak, effective August 2, 2023.

Aug 1, 2023 8-K

Incyte 8-K Report, Executive Changes (Jun 15, 2023)

Incyte Corporation's Form 8-K, dated June 15, 2023, reports the results of the Company's Annual Meeting of Stockholders held June 14, 2023, and two plan amendments approved at that meeting. Stockholders approved an increase of 12,500,000 shares under the Amended and Restated 2010 Stock Incentive Plan, from 53,953,475 to 66,453,475 shares, and an increase of 750,000 shares under the 1997 Employee Stock Purchase Plan, from 9,600,000 to 10,350,000 shares. Both plans were amended on April 13, 2023, and the full plan texts are filed as Exhibits 10.1 and 10.2. All nine director nominees were elected, including Julian C. Baker, Jean-Jacques Bienaimé, Otis W. Brawley, Paul J. Clancy, Jacqualyn A. Fouse, Edmund P. Harrigan, Katherine A. High, Hervé Hoppenot, and Susanne Schaffert. Stockholders approved the non-binding advisory vote on named executive officer compensation, with 169,320,952 votes for and 23,663,412 against. On the frequency of future say-on-pay votes, 191,089,985 stockholders favored every year, and the Board's recommendation of an annual vote was adopted. Ernst & Young LLP was ratified as the independent registered public accounting firm for fiscal 2023, with 194,500,211 votes for and 10,832,543 against. For investors, the filing is primarily administrative. It sets out the expanded equity capacity for employee compensation and confirms routine governance outcomes, with the say-on-pay and auditor ratification votes passing by substantial margins.

Jun 15, 2023 8-K

Incyte 8-K Report, Corporate Update (May 8, 2023)

Incyte Corporation's Board of Directors approved the appointment of Pablo J. Cagnoni, M.D., as President, Research and Development, on May 4, 2023. The appointment is effective June 5, 2023. The company reported the change under Item 8.01 (Other Events) of this Current Report on Form 8-K, which is dated May 8, 2023 and signed by Maria E. Pasquale, Executive Vice President and General Counsel. The filing is a single announcement of a senior leadership appointment. It does not state Dr. Cagnoni's compensation, prior positions, or any other terms of the appointment, and it does not discuss financial results, guidance, or other business developments. For investors, the key information is the leadership change itself: a named executive will hold the research and development leadership role starting June 5, 2023, and the board approved the appointment in advance of that date.

May 8, 2023 8-K

Incyte 8-K Report, Financial Results (May 2, 2023)

Incyte Corporation reported first-quarter 2023 results for the period ended March 31, 2023, in a press release furnished as Exhibit 99.1. Total GAAP revenues were $808.7 million versus $733.2 million a year earlier, and total net product revenues were $693.2 million (up 14% year over year). Jakafi net product revenues were $580.0 million (up 7%), and Opzelura net product revenues reached $56.6 million, up 343%, driven by the atopic dermatitis and vitiligo launch. GAAP net income fell to $21.7 million ($0.10 per diluted share) from $37.9 million ($0.17) a year earlier, as GAAP operating income declined to $24.8 million from $116.5 million, primarily reflecting promotional spending for the Opzelura launch and timing of certain expenses. On the pipeline, Incyte said it decided to focus on eight programs and discontinued six others. The Phase 3 LIMBER-304 and LIMBER-313 trials of parsaclisib with ruxolitinib were discontinued after interim analyses suggested they were unlikely to meet primary endpoints, and the FDA issued a complete response letter for once-daily ruxolitinib extended-release tablets. Zynyz (retifanlimab-dlwr) received accelerated approval in the U.S. for Merkel cell carcinoma, and Opzelura was approved in Europe for non-segmental vitiligo. Incyte raised the bottom end of its full-year 2023 Jakafi net product revenue guidance to $2.55 to $2.63 billion. Cash, cash equivalents and marketable securities were $3.1 billion at March 31, 2023, compared with $3.2 billion at December 31, 2022, which the company attributed to a reduction in accounts payable.

May 2, 2023 8-K

Incyte 8-K Report, Financial Results (Feb 7, 2023)

Incyte Corporation reported fourth-quarter and full-year 2022 financial results on February 7, 2023, as furnished in Exhibit 99.1, a press release that also provides 2023 financial guidance and updates on key clinical programs. Total GAAP revenues for fiscal 2022 were $3,394,635 thousand ($3.39 billion), up 14% from 2021, while total net product revenues were $2,746,897 thousand, up 18%. Jakafi net product revenues reached $2,409,225 thousand for the year (up 13%) and $647,493 thousand in the fourth quarter (up 9%). Opzelura generated $128,735 thousand in net product revenues for 2022 and $61,281 thousand in the fourth quarter. GAAP net income for 2022 was $340,660 thousand, or $1.52 per diluted share, compared with $948,581 thousand in 2021, which included a one-time tax benefit. Fourth-quarter GAAP net income was $28,461 thousand, or $0.13 per diluted share. For 2023, Incyte guided Jakafi net product revenues to $2.53 to $2.63 billion, other hematology/oncology net product revenues to $215 to $225 million, and GAAP research and development expenses to $1,610 to $1,650 million. GAAP SG&A expenses are guided to $1,050 to $1,150 million. The company stated that guidance excludes revenue from potential new product launches or future strategic transactions. Cash, cash equivalents and marketable securities totaled $3,238,965 thousand at December 31, 2022, up from $2,348,192 thousand a year earlier. The filing also notes a 2023 Jakafi patent extension through December 2028 from pediatric exclusivity, and an FDA PDUFA target action date of March 23, 2023 for the once-daily ruxolitinib XR formulation. Key pipeline catalysts flagged for 2023 include results from the Phase 3 parsaclisib trial in suboptimal ruxolitinib responders (expected at end of 2023), mid-2023 results from the pivotal AGAVE-201 trial of axatilimab in chronic GVHD, a CHMP opinion on ruxolitinib cream in vitiligo in Europe expected in the first half of 2023, and pediatric atopic dermatitis Phase 3 results for ruxolitinib cream expected by year-end.

Feb 7, 2023 8-K

Incyte 8-K Report, Financial Results (Nov 1, 2022)

Incyte Corporation furnished an 8-K on November 1, 2022 reporting results for its third fiscal quarter ended September 30, 2022. Total GAAP revenues were $823.3 million for the quarter versus $813.0 million a year earlier, and total net product revenues were $713.0 million, up 20% year over year, driven by Jakafi and Opzelura. Jakafi net product revenues were $619.6 million (up 13%), and Opzelura net product revenues were $38.1 million. GAAP net income was $112.8 million, or $0.50 per diluted share, compared with $181.7 million, or $0.82 per diluted share, in the prior-year quarter. GAAP operating income declined to $138.4 million from $235.4 million, mainly due to higher operating expenses. GAAP research and development rose 15% and GAAP selling, general and administrative expenses rose 40%, the latter tied to the dermatology commercial organization and the Opzelura launch. The company raised the bottom end of its full-year 2022 Jakafi net product revenue guidance to $2.38 to $2.40 billion, from $2.36 to $2.40 billion. It lowered other Hematology/Oncology net product revenue guidance to $200 to $210 million, from $210 to $240 million, citing unfavorable foreign currency changes. It reaffirmed its GAAP research and development guidance of $1.550 to $1.590 billion and its GAAP selling, general and administrative guidance of $950 to $1,000 million. Cash, cash equivalents and marketable securities totaled $3.0 billion at September 30, 2022, up from $2.3 billion at December 31, 2021. Pipeline and business development updates include an FDA target action date of March 23, 2023 for once-daily ruxolitinib XR, a pending acquisition of Villaris Therapeutics, which gives Incyte rights to auremolimab for vitiligo and other autoimmune diseases, and planned Phase 3 development of povorcitinib in hidradenitis suppurativa by year-end.

Nov 1, 2022 8-K

Incyte 8-K Report, Executive Changes (Oct 4, 2022)

Incyte Corporation filed this Form 8-K under Item 5.02 to report a board change. Effective October 1, 2022, the Board of Directors increased the number of authorized board members to nine and elected Susanne Schaffert, Ph.D. as a director. The filing states that Dr. Schaffert, age 55, previously spent 26 years at Novartis AG, most recently serving as President of Novartis Oncology from January 2019 until April 2022. She also sits on the board of directors of Rubius Therapeutics, Inc. The filing states there is no arrangement or understanding under which she was selected, no family relationship with other directors or executive officers, and the company is not aware of any transaction requiring disclosure under Item 404(a) of Regulation S-K. As a non-employee director, she will receive the same cash and equity compensation paid to the company's other non-employee directors, as described in the proxy statement for the 2022 Annual Meeting of Stockholders filed on April 29, 2022. For investors, this is a governance event rather than a financial one. The filing contains no financial results or guidance. Its relevance lies in the expansion of the board to nine members and the addition of a director with substantial pharmaceutical oncology industry experience.

Oct 4, 2022 8-K

Incyte 8-K Report, Financial Results (Aug 2, 2022)

Incyte Corporation reported second quarter 2022 results for the three months ended June 30, 2022, per a press release furnished as Exhibit 99.1 to this Form 8-K. Total GAAP revenues rose 29% year-over-year to $911.4 million, and total product revenues were $663.9 million. GAAP net income was $161.4 million, or $0.72 per diluted share, compared with $149.5 million, or $0.67 per diluted share, a year earlier. Revenue growth was boosted by $130.0 million in milestone and contract revenues, versus $10.0 million in the prior-year quarter. Jakafi net product revenues were $597.7 million, up 13% year-over-year, driven by volume growth. The company raised the bottom end of its full-year 2022 Jakafi net product revenue guidance to $2.36 to $2.40 billion, from $2.33 to $2.40 billion. Other Hematology/Oncology net product revenue guidance of $210 to $240 million and GAAP operating expense guidance were unchanged. Opzelura cream reported $16.6 million in net product revenue for the quarter, with about 48,000 units shipped. The company noted that revenues were temporarily affected by the shift from free drug to paid prescriptions in atopic dermatitis. Cash, cash equivalents and marketable securities totaled $2.7 billion as of June 30, 2022. Pipeline news included FDA approval of Opzelura for nonsegmental vitiligo in July 2022 and a European marketing authorization application under review. Incyte also ended development of itacitinib in treatment-naive chronic GVHD, and the FDA is reviewing an NDA for once-daily ruxolitinib extended release, with a PDUFA target date of March 23, 2023. Operating expenses rose sharply in the quarter, with GAAP SG&A up 50% year-over-year, mainly due to dermatology commercial launch activities.

Aug 2, 2022 8-K

Shareholder Matters

Incyte 8-K Report, Shareholder Vote Results (Jun 16, 2022)

Incyte Corporation filed this Form 8-K on June 16, 2022 to report the results of its Annual Meeting of Stockholders, held June 15, 2022. The filing covers three matters put to a vote: the election of eight directors, a non-binding advisory vote on named executive officer compensation, and ratification of Ernst & Young LLP as the independent registered public accounting firm for fiscal 2022. No other corporate actions, financial results, or transactions are reported in this filing. All eight director nominees were elected. Each received substantially more votes For than Against, though the Against and Abstain counts varied meaningfully across nominees. Paul J. Clancy drew the most Against votes at 16,776,129, while Otis W. Brawley, Edmund P. Harrigan, and Jacqualyn A. Fouse received the fewest, at roughly 2.1 to 3.5 million Against votes each. Hervé Hoppenot had the highest number of Abstain votes at 1,471,584. Each director received 11,714,999 broker non-votes. Stockholders approved the compensation of the named executive officers on a non-binding advisory basis, with 170,569,049 votes For and 17,789,075 Against. Ernst & Young LLP's ratification as auditor received 191,612,479 For, 8,375,994 Against, and 166,662 Abstain votes. The filing is a procedural disclosure of shareholder voting outcomes and does not contain financial performance data.

Jun 16, 2022 8-K

Incyte 8-K Report, Financial Results (May 3, 2022)

Incyte Corporation reported first-quarter 2022 results on May 3, 2022, with total GAAP revenues of $733.2 million, up from $604.7 million in the prior-year quarter. Product and royalty revenues of $728.2 million grew 20% year over year, led by Jakafi net product revenues of $544.5 million (up 17%), with higher Olumiant royalty revenues (up 49%) and Opzelura launch sales of $12.8 million. GAAP net income was $38.0 million, or $0.17 per diluted share, compared with $53.5 million, or $0.24 per diluted share, a year earlier. Non-GAAP diluted EPS was $0.55, versus $0.67. The company cited higher GAAP selling, general and administrative expenses (up 36%) and research and development expenses (up 15%), driven by its dermatology commercial organization, the Opzelura launch and late-stage development. Incyte raised the low end of its full-year 2022 Jakafi net product revenue guidance to $2.33 to $2.40 billion from $2.3 to $2.4 billion, and reaffirmed its other 2022 guidance. The guidance excludes Opzelura revenue and any potential future strategic transactions. Cash, cash equivalents and marketable securities totaled $2.5 billion as of March 31, 2022. The quarter's clinical and regulatory news centered on Opzelura (ruxolitinib cream). Over 38,000 new patients were treated in the first quarter, and payer agreements now cover 146 million total lives. A supplemental NDA and a European MAA for ruxolitinib cream in vitiligo are under review, and the FDA PDUFA target action date was extended to July 18, 2022. The company also highlighted a planned once-daily ruxolitinib NDA filing in the first half of 2022 and positive CHMP opinions for ruxolitinib in GVHD and capmatinib in NSCLC.

May 3, 2022 8-K

Incyte 8-K Report, Executive Changes (Apr 21, 2022)

Incyte Corporation filed this Form 8-K on April 21, 2022 under Item 5.02 (Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers). The filing reports that Wendy L. Dixon notified the company on April 18, 2022 that she will retire from the Board of Directors, effective at the time of the Company's 2022 Annual Meeting of Stockholders. Dr. Dixon has served on the Board since 2010. The filing does not describe a replacement director, any compensation arrangements, or the reasons for her departure. For investors, this is a routine board-governance notice with no financial figures, guidance, or operational disclosures. Its main significance is the planned change in board composition, which takes effect when the 2022 annual meeting is held.

Apr 21, 2022 8-K

Incyte 8-K Report, Financial Results (Feb 8, 2022)

Incyte Corporation reported fourth-quarter and full-year 2021 results, with total product and royalty revenues of $813 million (up 20%) in Q4 2021 and $2.891 billion (up 17%) for the full year. Jakafi net product revenues were $592 million (up 15%) in Q4 and $2.135 billion (up 10%) for 2021. Total GAAP revenues were $862.9 million in Q4 (up 9%) and $2.986 billion for the year (up 12%). Full-year GAAP net income of $948.6 million includes a $569 million one-time non-cash income tax benefit from releasing the valuation allowance on most U.S. deferred tax assets. Excluding non-GAAP adjustments, full-year net income was $612.0 million, and Q4 non-GAAP net income was $22.6 million. Cash, cash equivalents and marketable securities were $2.3 billion at December 31, 2021, up from $1.8 billion a year earlier. The company provided 2022 guidance of $2.3 to $2.4 billion for Jakafi net product revenues and $210 to $240 million for other hematology/oncology net product revenues. The guidance excludes Opzelura revenue and any potential future strategic transactions. Opzelura, launched in atopic dermatitis in October 2021, had nearly 19,000 patients treated from launch through year-end. A priority review for ruxolitinib cream in vitiligo in the U.S. has a PDUFA target action date of April 18, 2022. Incyte also withdrew its U.S. NDA for parsaclisib in relapsed or refractory follicular lymphoma, marginal zone lymphoma and mantle cell lymphoma, described as a business decision, and discontinued the Phase 3 program for baricitinib in systemic lupus erythematosus. Operating expenses rose in the fourth quarter, driven by the build-out of the dermatology commercial organization, the Opzelura launch, and $127 million of upfront consideration under the Syndax collaboration. Full-year GAAP research and development expense fell 34% from 2020, which included $805 million of MorphoSys upfront consideration and a $120 million priority review voucher purchase. Incyte also opted out of continued development of MCLA-145 in January.

Feb 8, 2022 8-K

Incyte 8-K Report, Executive Changes (Jan 14, 2022)

Incyte Corporation filed this Form 8-K dated January 14, 2022 under Item 5.02 to report a leadership change in its finance organization. On January 10, 2022, Paul Trower notified the company of his intention to retire as Division Vice President, Finance and Principal Accounting Officer, effective March 11, 2022. Effective March 11, 2022, the board of directors appointed Thomas Tray, age 44, as Vice President, Finance and Chief Accounting Officer (Principal Accounting Officer). Mr. Tray joined Incyte in June 2005 as Manager, External Reporting, and most recently served as Vice President and Controller. Before joining Incyte, he worked in the audit practice of PricewaterhouseCoopers LLP from August 1999 through May 2005. He holds a B.S. in Accounting from Mount Saint Mary's University and an Executive MBA in Pharmaceutical Marketing from Saint Joseph's University. The filing states there are no arrangements or understandings under which Mr. Tray was selected, no family relationships with the company's directors or executive officers, and no direct or indirect material interest in any related-party transaction requiring disclosure under Item 404(a) of Regulation S-K. The report was signed by Christiana Stamoulis, Executive Vice President and Chief Financial Officer.

Jan 14, 2022 8-K

Regulation FDExhibits & Filings

Incyte 8-K Report, Financial Results (Nov 2, 2021)

Incyte Corporation reported third-quarter 2021 financial results for the period ended September 30, 2021, and provided an update on its development portfolio. Total GAAP revenues were $812,987 thousand (about $813.0 million), up 31% from $620,643 thousand in the prior-year quarter. Product and royalty revenues were $777,987 thousand, up 25%, led by Jakafi net product revenues of $547,373 thousand, up 12%. GAAP net income was $181,739 thousand, or $0.82 per diluted share, compared with a net loss of $15,203 thousand, or $(0.07) per share, a year earlier. The prior-year quarter included $120 million for an FDA priority review voucher, which drove the 24% decrease in GAAP research and development expenses, while selling, general and administrative expenses rose 58% to support the dermatology commercial launch. The company reported three regulatory approvals: Opzelura (ruxolitinib) cream for atopic dermatitis in the U.S., Jakafi for chronic graft-versus-host disease in the U.S., and Minjuvi (tafasitamab) for relapsed or refractory DLBCL in Europe. It also reported royalty growth, including Olumiant product royalty revenues up 202%, which the filing attributes to use of Olumiant for COVID-19 treatment. Cash, cash equivalents and marketable securities totaled $2.3 billion at September 30, 2021, compared with $1.8 billion at December 31, 2020. Incyte reaffirmed its full-year 2021 guidance, including Jakafi net product revenues of $2,125 to $2,170 million and GAAP research and development expenses of $1,350 to $1,390 million. The guidance excludes Opzelura revenue in the U.S., Minjuvi revenue in Europe, and any potential future strategic transactions. The filing also points to several upcoming regulatory submissions, including an NDA for once-daily ruxolitinib planned for early 2022, and PDUFA target action dates of April 30, 2022 and August 30, 2022 for parsaclisib in certain lymphoma indications.

Nov 2, 2021 8-K

Incyte 8-K Report, Regulation FD Disclosure (Nov 2, 2021)

Incyte Corporation issued a corporate statement on November 2, 2021, furnished under Item 7.01 (Regulation FD Disclosure), to provide additional information on certain statements made during its third quarter 2021 earnings call that day. The statement concerns Opzelura (ruxolitinib) cream, the company's topical JAK inhibitor approved in the United States for short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised patients 12 years of age and older. Incyte says it has received three product complaints related to texture. It is informing the U.S. Food and Drug Administration, investigating the complaints, and conducting a root cause analysis across all batches. Early analytical testing of both the 5 gram and 60 gram batches in question shows no issues that would affect safety or efficacy. The company attributes the texture to a very small quantity of active pharmaceutical ingredient not fully dissolving, which has on occasion produced a slight gritty texture. Distribution of the affected batches has been suspended. Incyte states it has no commercial supply issues at this time. 60 gram tubes that have passed release and 90-day quality control testing remain available for distribution, and additional batches continue to be manufactured. The statement also notes that ruxolitinib cream is in Phase 3 development for vitiligo in the TRuE-V program, with results recently announced.

Nov 2, 2021 8-K

Material AgreementsFinancial Events

Incyte 8-K Report, Executive Changes (Sep 28, 2021)

Incyte Corporation filed this Form 8-K under Item 5.02 (Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers) to report a board change. Effective September 27, 2021, the Board of Directors increased the number of authorized board members to nine and elected Otis W. Brawley, M.D. as a director. Dr. Brawley, age 62, is a Bloomberg Distinguished Professor of Oncology and Epidemiology at Johns Hopkins University, a role he has held since January 2019. Previously, he served as Chief Medical and Scientific Officer of the American Cancer Society from April 2007 to December 2018, and as director of the Georgia Cancer Center at Grady Memorial Hospital from January 2002 to August 2007. He is also a member of the boards of directors of Lyell Immunopharma, Inc. and PDS Biotechnology Corporation. The filing states there is no arrangement or understanding under which he was selected, no family relationship with other directors or executive officers, and no transaction requiring disclosure under Item 404(a) of Regulation S-K. As a non-employee director, Dr. Brawley will receive the same cash and equity compensation paid to the Company's other non-employee directors, as described in the Company's 2021 proxy statement filed April 16, 2021 and its Current Report on Form 8-K filed May 27, 2021. The filing contains no further financial results or operational disclosures.

Sep 28, 2021 8-K

Incyte 8-K Report, Material Agreement (Aug 20, 2021)

On August 20, 2021, Incyte Corporation filed a Current Report on Form 8-K disclosing that on August 18, 2021, the Company and its subsidiary, Incyte Holdings Corporation, entered into a revolving credit and guaranty agreement (the "Credit Agreement") with J.P. Morgan Chase Bank, N.A. as administrative agent and a group of lenders. The Credit Agreement provides an unsecured three-year revolving credit facility of up to $500.0 million. The facility allows the Company to request increases to the maximum revolving commitments or add incremental term loan facilities, capped at $250.0 million plus an additional amount subject to a pro forma consolidated leverage ratio test. Obligations are guaranteed by Incyte Holdings and, subject to customary exceptions, each existing and future material domestic subsidiary. Loans bear interest at either a base rate plus 0.125% to 0.875%, or a Eurodollar rate plus 1.125% to 1.875%, depending on the consolidated leverage ratio. Commitment fees on undrawn amounts range from 0.150% to 0.225% per annum. Borrowings may be prepaid without premium or penalty. The Credit Agreement includes customary representations, affirmative and negative covenants, and a maximum consolidated leverage ratio of 3.50 to 1.00, subject to exceptions for acquisitions above an agreed threshold. Events of default include a change of control, upon which lenders may terminate commitments and accelerate obligations. The full agreement is to be filed as an exhibit to the Company's Form 10-Q for the quarter ended September 30, 2021.

Aug 20, 2021 8-K