Ponatinib Hydrochloride

Total revenue of $1.67 billion and total net sales of $1.49 billion in the second quarter of 2026, an increase of 38% and 40%, respectively, compared to the second quarter of 2025 Total net sales, excluding the one-time, non-cash benefit for Opzelura ® (ruxolitinib) cream related to the CMS settlement, * grew 17% compared to the prior year period Jakafi ® /Jakafi XR ™ (ruxolitinib) net sales of $817 million, an increase of 7% compared to the same period in 2025 Opzelura net sales of $450 million, an increase of 173% versus the prior year period; excluding the one-time, non-cash benefit, * Opzelura net sales were $204 million, an increase of 24% versus the prior year period ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); Hematology and Oncology portfolio net sales of $222 million, an increase of 69%, compared to the second quarter of 2025 Updating 2026 full year financial guidance for total net sales and operating expenses Ten clinical data readouts, including data from four registrational trials, expected throughout the second half of 2026 Conference Call and Webcast Scheduled Today at 8:00 a.m. ET WILMINGTON, Del.--(BUSINESS WIRE)-- $INCY --Incyte (Nasdaq:INCY) today reported financial results for the second quarter of 2026 and provided a business update. “Our second quarter was marked by broad-based sales growth, continued pipeline progress and strategic business development,” said Bill Meury, Chief Executive Officer, Incyte. “Every marketed product contributed to growth, reflecting the strength of our commercial portfolio and execution. We also recently strengthened our Hematology franchise through the acquisition of latarcibart, a potentially transformative medicine for von Willebrand disease currently in Phase 3 development. With ten data readouts expected in the second half of 2026, alongside product launches through early next year, we are well positioned for our next phase of growth.” Second Quarter 2026 Results Total revenue: Total revenue was $1.67 billion, an increase of 38% compared to the second quarter of 2025, * primarily driven by an increase in total net sales across marketed products. Total net sales: Total net sales were $1.49 billion, an increase of 40% compared to the second quarter of 2025. * The increase was driven by a one-time, non-cash benefit of $246 million associated with the reversal of previously established accrual balances through March 31, 2026, for Opzelura ® (ruxolitinib) cream, and increased demand across marketed products, including continued demand for Jakafi ® (ruxolitinib) across all indications, Opzelura in atopic dermatitis (AD) and vitiligo, Niktimvo ™ (axatilimab-csfr) in chronic graft versus host disease (GVHD), Monjuvi ® (tafasitamab-cxix)/Minjuvi ® (tafasitamab) in follicular lymphoma (FL) and Zynyz ® (retifanlimab-dlwr) in squamous cell carcinoma of the anal canal (SCAC). Cost of sales: GAAP and non-GAAP cost of sales were $105.0 million and $98.6 million, respectively, representing 7% of total net sales. Research and development (R&D) expenses: GAAP and non-GAAP R&D expenses were $517.0 million and $478.8 million, an increase of 4% and 5%, respectively, compared to the prior year period. Selling, general and administrative (SG&A) expenses: GAAP and non-GAAP SG&A expenses were $351.7 million and $323.6 million, an increase of 6% for each, respectively, compared to the prior year period. Cash, cash equivalents and marketable securities position: As of June 30, 2026 and December 31, 2025, cash, cash equivalents and marketable securities totaled $4.5 billion and $3.6 billion, respectively. Opzelura Financial Impact Related to Agreement with CMS As a result of the agreement with CMS, * the total estimated incremental impact on Opzelura net sales for the full year 2026 is $300 - $310 million which includes the reversal of previously established accrual balances through the first quarter of 2026 and effects of an improved gross-to-net (GTN) pro a go-forward basis as summarized in the table below. Opzelura Net Sales 1 Total estimated incremental impact on Opzelura net sales for the full year 2026 $300 - $310 million One-time, non-cash benefit of the reversal of previously established accrued balances through the first quarter of 2026 ending March 31, 2026 $246 million Impact on second quarter of 2026 net sales resulting in improved GTN $15 million Estimated impact on third and fourth quarters of 2026 net sales from improved GTN $40 - $50 million 1 Totals may not add due to rounding. 2026 Financial Guidance Incyte is raising its full year 2026 total net sales guidance to $5,130 - $5,260 million, reflecting the impact of the agreement with CMS related to the Opzelura line extension, * as well as the continued strong performance of its Hematology and Oncology growth products, including Niktimvo, Monjuvi/Minjuvi and Zynyz. Incyte is raising its full year 2026 Opzelura net sales guidance to $1,050 - $1,100 million and full year 2026 Hematology and Oncology net sales guidance to $860 - $890 million. Incyte is also raising its full year 2026 operating expense guidance. Total GAAP R&D and SG&A operating expense guidance is $4,915 - $4,995 million and total non-GAAP R&D and SG&A operating expense guidance is $4,625 - $4,695 million. The revised guidance reflects the impact of the acquisition of Vega Therapeutics, including an IPR&D expense of approximately $1,270 million expected in the third quarter 2026 associated with the upfront payment and related transaction costs, as well as $50 million of incremental ongoing R&D investments related to the development of latarcibart. The transaction upfront payment is expected to result in an IPR&D expense reflected in the third quarter and full year 2026 GAAP and non-GAAP financial results. Incyte’s guidance for the fiscal year 2026 is summarized below. Current Previous Total net sales $5,130 - $5,260 million $4,770 - $4,940 million Jakafi net sales (1) unchanged $3,220 - $3,270 million Opzelura net sales (2) $1,050 - $1,100 million $750 - $790 million Hematology and Oncology net sales (3) $860 - $890 million $800 - $880 million Total GAAP R&D and SG&A operating expenses (4) $4,915 - $4,995 million $3,495 - $3,675 million Total Non-GAAP R&D and SG&A operating expenses (4,5) $4,625 - $4,695 million $3,205 - $3,375 million 1 Includes Jakafi XR ™ (ruxolitinib) net sales. 2 Includes net sales for moderate atopic dermatitis in Europe, which is anticipated to be approved in the second half of 2026. 3 Includes Pemazyre ® (pemigatinib) in the U.S., Canada, Europe, Japan, Asia Pacific (APAC), Middle East and Africa (MEA), and Latin America (LatAm); Niktimvo and Monjuvi in the U.S.; Zynyz in the U.S., Europe and Japan; Iclusig ® (ponatinib) in Europe and MEA; and Minjuvi in Canada, Europe, Japan, APAC, MEA and LatAm. 4 Includes upfront cost related to the acquisition of Vega Therapeutics, which will be recognized as an IPR&D expense impacting both the third quarter and full-year 2026 in addition to incremental R&D investment related to latarcibart. 5 Adjusted to exclude the estimated cost of stock-based compensation. Key Business Updates Hematology Jakafi XR ™ (ruxolitinib) In May, Jakafi XR was approved by the FDA for the treatment of adults with intermediate- or high-risk myelofibrosis (MF) and adults with polycythemia vera (PV) who have had an inadequate response to or are intolerant to hydroxyurea, as well as for adults and children aged 12 years and older with steroid-refractory acute GVHD or chronic GVHD after failure of one or two lines of systemic therapy. Monjuvi/Minjuvi Data from the pivotal Phase 3 frontMIND trial evaluating tafasitamab and lenalidomide in addition to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone) as a first-line treatment for adults with previously untreated diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) were presented as a featured oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in May and during the Plenary Abstract session at the 2026 European Hematology Association (EHA) Congress in June. These results, which were also recently published in The Lancet , demonstrate that treatment with Tafa-Len-R-CHOP resulted in statistically significant and clinically meaningful improvements in progression-free survival (PFS), the primary endpoint in the study. Global regulatory submissions for Monjuvi/Minjuvi as a treatment for patients with newly diagnosed DLBCL were submitted and accepted in the second quarter of 2026. The Company anticipates a potential approval and launch in the U.S. in the first quarter of 2027. In June, Minjuvi was approved by Japan’s Ministry of Health, Labour and Welfare (MHLW) for the treatment of adults with relapsed or refractory DLBCL in combination with lenalidomide. This approval represents the second regulatory approval for Minjuvi in Japan. Niktimvo Topline data from the Phase 2 trial evaluating axatilimab in combination with ruxolitinib in patients with newly diagnosed chronic GVHD are anticipated in the second half of 2026. INCA033989 (mutCALR) The registrational Phase 3 study (EXCALIBUR-ET2), evaluating INCA033989 in mutCALR positive patients with ET who are resistant or intolerant to at least one prior cytoreductive therapy was initiated in mid-2026. Updated Phase 1 data for INCA033989 were presented at the 2026 EHA Congress, demonstrating robust clinical activity, durable hematologic and symptom responses, molecular responses consistent with potential disease modification and a favorable tolerability pro patients with mutCALR-positive essential thrombocythemia (ET) and MF. Data from the Phase 1 cohort evaluating INCA033989 as a monotherapy and in combination with ruxolitinib in treatment naïve MF patients are anticipated in the second half of 2026. A Phase 1 study evaluating INCA033989 as a subcutaneous (SC) administration in mutCALR positive patients was initiated in the second quarter of 2026. INCB160058 (JAK2V617F) Following a comprehensive review of available data, the Company has discontinued further development of INCB160058 to prioritize its next-generation JAK2V617F-targeted pipeline. Latarcibart (formerly VGA039) In July, data from the Phase 1/2 multidose study of latarcibart in patients with von Willebrand disease (VWD) were presented at the 2026 International Society on Thrombosis and Haemostasis (ISTH) Congress, demonstrating that once-monthly SC treatment with latarcibart resulted in an 81% median reduction in annualized bleeding rate (ABR) across all bleeding categories and VWD types. Latarcibart is being evaluated in a global Phase 3, single-arm crossover study (VIVID-6) assessing the safety and efficacy of once-monthly SC administration of latarcibart as prophylaxis for bleeding in patients with all types of VWD. Topline data from the VIVID-6 study are anticipated in early 2029. Oncology INCB161734 (KRASG12D) The Phase 3 study (DAWN-303) evaluating INCB161734 as a first-line treatment in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) in combination with standard-of-care chemotherapy (mFOLFIRINOX or GEMNabP) versus chemotherapy alone is ongoing. Data from the ongoing Phase 1 trial evaluating INCB161734 in combination with standard-of-care chemotherapy (mFOLFOX and GemNabP) as a first-line treatment in patients with metastatic PDAC, as well as data evaluating INCB161734 in combination with cetuximab in patients with advanced/metastatic colorectal cancer (CRC), will be highlighted as rapid oral presentations at the 2026 European Society for Medical Oncology (ESMO) Congress, being held October 23–27 in Madrid, Spain. INCA33890 (TGFβR2xPD-1) † The Phase 3 study evaluating INCA33890 in combination with standard-of-care chemotherapy and bevacizumab as a first-line treatment in patients with microsatellite stable colorectal cancer (MSS CRC) is ongoing. Data from the ongoing Phase 1 trial evaluating INAC33890 in combination with standard-of-care therapies as a first-line treatment in patients with MSS CRC will be highlighted in a rapid oral presentation at the 2026 ESMO Congress. INCB123667 (CDK2) A Phase 3 study evaluating INCB123667 in first-line maintenance ovarian cancer is expected to initiate in the second half of 2026. Preliminary efficacy data from the ongoing Phase 1 trial evaluating INCB123667 in combination with bevacizumab in patients with recurrent epithelial ovarian cancer (rEOC) will be highlighted in a rapid oral presentation at the 2026 ESMO Congress. Inflammation and Autoimmunity (IAI) Opzelura In June, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending the approval of Opzelura cream for the treatment of moderate AD in adult patients for whom topical corticosteroids (TCSs) and topical calcineurin inhibitors (TCIs) are inadequate or inappropriate. The Company expects a regulatory decision in the third quarter of 2026. Topline results from the Phase 3 studies (TRuE-HS1 and TRuE-HS2) evaluating ruxolitinib cream in mild to moderate hidradenitis suppurativa (HS) are anticipated in the fourth quarter of 2026. Povorcitinib The New Drug Application (NDA) submission for povorcitinib as a treatment for patients with moderate to severe HS was accepted by the FDA in the first quarter of 2026. The Company anticipates potential approval and launches in late-2026 in the European Union and the first quarter of 2027 in the U.S. Data from the Phase 3 studies (STOP-PN1 and STOP-PN2) evaluating povorcitinib in patients with moderate to severe prurigo nodularis (PN) are anticipated in the fourth quarter of 2026. Topline data from the Phase 2 proof-of-concept trial for povorcitinib in asthma are anticipated in the second half of 2026. Corporate Updates In July, the Company announced a global collaboration and license agreement with Halozyme to support the subcutaneous formulation development of INCA033989 utilizing Halozyme’s proprietary ENHANZE ® Technology. In July, the Company completed its acquisition of Vega Therapeutics, Inc. , a wholly owned subsidiary of Star Therapeutics, LLC. The acquisition adds latarcibart, a novel investigational monoclonal antibody in Phase 3 development for patients with VWD, to its late-stage pipeline. Under the terms of the parties’ stock purchase agreement, Incyte acquired all outstanding shares of Vega Therapeutics for $1.25 billion. Star Therapeutics will be eligible to receive up to $750 million in additional payments upon the achievement of sales milestones. In May, the Company expanded its use of artificial intelligence (AI) across its discovery and development pipeline, entering a strategic collaboration with Edison Scientific to employ their AI scientist Kosmos, and expanding its existing collaboration with Genesis Molecular AI to build and deploy state-of-the-art AI models to accelerate discovery of novel molecules for collaboration targets selected by Incyte. In the second quarter of 2026, the Company entered into an exclusive license agreement with Mirum Pharmaceuticals, granting Mirum worldwide rights to zilurgisertib, an ALK2 inhibitor in development for fibrodysplasia ossificans progressiva (FOP). Under the terms of the agreement, Incyte received an upfront payment and is eligible to receive additional development and regulatory milestone payments, as well as sales-based milestones and tiered royalties in the mid-to-high single digit percent range on worldwide net sales. 2026 Second Quarter Financial Results The financial measures presented in this press release for the three and six months ended June 30, 2026 and 2025 have been prepared by the Company in accordance with U.S. Generally Accepted Accounting Principles (“GAAP”), unless otherwise identified as a Non-GAAP financial measure. Management believes that Non-GAAP information is useful for investors, when considered in conjunction with Incyte’s GAAP disclosures. Management uses such information internally and externally for establishing budgets, operating goals and financial planning purposes. These metrics are also used to manage the Company’s business and monitor performance. The Company adjusts, where appropriate, for expenses in order to reflect the Company’s core operations. The Company believes these adjustments are useful to investors by providing an enhanced understanding of the financial performance of the Company’s core operations. The metrics have been adopted to align the Company with disclosures provided by industry peers. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used in conjunction with and to supplement Incyte’s operating results as reported under GAAP. Non-GAAP measures may be defined and calculated differently by other companies in our industry. As changes in exchange rates are an important factor in understanding period-to-period comparisons, management believes the presentation of certain revenue results on a constant currency basis in addition to reported results helps improve investors’ ability to understand the Company’s operating results and evaluate its performance in comparison to prior periods. Constant currency information compares results between periods as if exchange rates had remained constant period over period. The Company calculates constant currency by calculating current year results using prior year foreign currency exchange rates and generally refers to such amounts calculated on a constant currency basis as excluding the impact of foreign exchange or being on a constant currency basis. These results should be considered in addition to, not as a substitute for, results reported in accordance with GAAP. Results on a constant currency basis, as the Company presents them, may not be comparable to similarly titled measures used by other companies and are not measures of performance presented in accordance with GAAP. Financial Highlights Financial Highlights (unaudited, in thousands, except per share amounts) Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 Total GAAP revenues $ 1,674,039 $ 1,215,529 $ 2,946,715 $ 2,268,427 Total GAAP operating income 697,898 530,314 999,015 735,482 Total Non-GAAP operating income 773,044 382,579 1,166,717 666,220 GAAP net income 585,605 404,999 888,935 563,202 Non-GAAP net income 643,359 311,927 1,017,786 541,386 GAAP basic EPS $ 2.92 $ 2.09 $ 4.45 $ 2.91 Non-GAAP basic EPS $ 3.21 $ 1.61 $ 5.09 $ 2.79 GAAP diluted EPS $ 2.81 $ 2.04 $ 4.28 $ 2.84 Non-GAAP diluted EPS $ 3.09 $ 1.57 $ 4.90 $ 2.73 Revenue Details Revenue Details (unaudited, in thousands) Three Months Ended June 30, % Change (as reported) % Change (constant currency) 1 Six Months Ended June 30, % Change (as reported) % Change (constant currency) 1 2026 2025 2026 2025 Net sales Jakafi 2 $ 816,659 $ 763,788 7 % NA $ 1,574,414 $ 1,473,200 7 % NA Opzelura 449,736 164,499 173 % 173 % 592,751 283,204 109 % 108 % Iclusig 34,394 32,729 5 % 3 % 69,857 62,273 12 % 5 % Pemazyre 23,418 22,192 6 % 5 % 45,961 40,632 13 % 11 % Minjuvi/Monjuvi 53,686 31,131 72 % 72 % 102,913 60,682 70 % 67 % Niktimvo 60,309 36,154 67 % 67 % 115,397 49,767 132 % 132 % Zynyz 49,947 8,921 460 % 458 % 91,340 11,930 666 % 661 % Total net sales 1,488,149 1,059,414 40 % 40 % 2,592,633 1,981,688 31 % 30 % Royalty revenues: Jakavi 124,190 109,714 13 % 12 % 229,746 201,859 14 % 15 % Olumiant 38,479 33,482 15 % 16 % 74,886 64,282 16 % 14 % Tabrecta 6,691 6,632 1 % NA 12,673 13,045 (3 %) NA Other 5,330 1,287 314 % NA 8,577 2,553 236 % NA Total royalty revenues 174,690 151,115 16 % 325,882 281,739 16 % Total net sales and royalty revenues 1,662,839 1,210,529 37 % 2,918,515 2,263,427 29 % Milestone and contract revenues 11,200 5,000 124 % 124 % 28,200 5,000 464 % 464 % Total GAAP revenues $ 1,674,039 $ 1,215,529 38 % $ 2,946,715 $ 2,268,427 30 % NA = not applicable 1 Percentage change in constant currency is calculated using 2025 foreign exchange rates to recalculate 2026 results. 2 Second quarter 2026 Jakafi net sales include Jakafi and Jakafi XR following the launch of Jakafi XR in the second quarter of 2026. Net Sales and Royalty Revenues Total net sales and royalty revenue for the quarter ended June 30, 2026 increased 37% over the prior year comparative period. Total net sales for the quarter ended June 30, 2026 increased 40% over the prior year comparative period. Jakafi net sales increased 7% in the second quarter of 2026 versus the prior year comparable period to $817 million, primarily driven by a 9% increase in paid demand and growth across all indications. Jakafi inventory levels were within normal range at the end of the second quarter of 2026. Opzelura net sales increased 173% in the second quarter of 2026 versus the prior year comparable period to $450 million. The increase was driven in part by a one-time, non-cash benefit of $246 million associated with the reversal of previously established accrual balances through March 31, 2026, for Opzelura. Net growth was also driven by increased patient demand in both AD and vitiligo. Opzelura inventory levels were within normal range at the end of the second quarter of 2026. Hematology and oncology net sales increased 69% in the second quarter of 2026 versus the prior year comparable period to $222 million, driven by increased demand for Niktimvo, Monjuvi/Minjuvi and Zynyz. Operating Expenses INCYTE CORPORATION RECONCILIATION OF REPORTED TO ADJUSTED RESULTS FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 2026 and 2025 (unaudited, in thousands) Three Months Ended June 30, 2026 Cost of Sales 1 Research and Development 2 Selling, General and Administrative 3 Operating Income Net Income GAAP (as reported) $ 104,957 $ 516,950 $ 351,735 $ 697,898 $ 585,605 Adjustments - Add / (Subtract) Non-cash stock compensation from equity awards (932 ) (38,189 ) (28,142 ) 67,263 67,263 Amortization of acquired product rights (5,384 ) — — 5,384 5,384 Loss on change in fair value of contingent consideration — — — 2,499 2,499 Non-cash interest — — — — 81 (Gain) on equity investments — — — — (9,805 ) Tax effect of Non-GAAP pre-tax adjustments — — — — (7,668 ) Non-GAAP (as adjusted) $ 98,641 $ 478,761 $ 323,593 $ 773,044 $ 643,359 Three Months Ended June 30, 2025 Cost of Sales 1 Research and Development 2 Selling, General and Administrative 3 Operating Income Net Income GAAP (as reported) $ 78,766 $ 494,917 $ 331,022 $ 530,314 $ 404,999 Adjustments - Add / (Subtract) Non-cash stock compensation from equity awards (838 ) (37,700 ) (26,071 ) 64,609 64,609 Contract dispute settlement — — — (242,251 ) (242,251 ) Amortization of acquired product rights (5,384 ) — — 5,384 5,384 Loss on change in fair value of contingent consideration — — — 22,761 22,761 Escient acquisition related compensation expense — (1,582 ) (180 ) 1,762 1,762 Non-cash interest — — — — 81 Loss on equity investments — — — — 4,151 Tax effect of Non-GAAP pre-tax adjustments — — — — 50,431 Non-GAAP (as adjusted) $ 72,544 $ 455,635 $ 304,771 $ 382,579 $ 311,927 Contacts Media media@incyte.com Investors ir@incyte.com Read full story here