Incyte Reports Second Quarter 2026 Financial Results and Provides Business Updates
Key Terms
gaap financial
non-gaap financial
gross-to-net (gtn) financial
iprd financial
new drug application (nda) regulatory
annualized bleeding rate (abr) medical
Total revenue of
Total net sales, excluding the one-time, non-cash benefit for Opzelura® (ruxolitinib) cream related to the CMS settlement,* grew
Jakafi®/Jakafi XR™ (ruxolitinib) net sales of
Opzelura net sales of
Hematology and Oncology portfolio net sales of
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
“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
, an increase of$1.67 billion 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
, an increase of$1.49 billion 40% compared to the second quarter of 2025.* The increase was driven by a one-time, non-cash benefit of 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).$246 million -
Cost of sales: GAAP and non-GAAP cost of sales were
and$105.0 million , respectively, representing$98.6 million 7% of total net sales. -
Research and development (R&D) expenses: GAAP and non-GAAP R&D expenses were
and$517.0 million , an increase of$478.8 million 4% and5% , respectively, compared to the prior year period. -
Selling, general and administrative (SG&A) expenses: GAAP and non-GAAP SG&A expenses were
and$351.7 million , an increase of$323.6 million 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
and$4.5 billion , respectively.$3.6 billion
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
|
Opzelura Net Sales1 |
|
Total estimated incremental impact on Opzelura net sales for the full year 2026 |
|
|
One-time, non-cash benefit of the reversal of previously established accrued balances through the first quarter of 2026 ending March 31, 2026 |
|
|
Impact on second quarter of 2026 net sales resulting in improved GTN |
|
|
Estimated impact on third and fourth quarters of 2026 net sales from improved GTN |
|
|
1Totals may not add due to rounding. |
||
2026 Financial Guidance
Incyte is raising its full year 2026 total net sales guidance to
Incyte is also raising its full year 2026 operating expense guidance. Total GAAP R&D and SG&A operating expense guidance is
Incyte’s guidance for the fiscal year 2026 is summarized below.
|
Current |
Previous |
||
Total net sales |
|
|
||
Jakafi net sales(1) |
unchanged |
|
||
Opzelura net sales(2) |
|
|
||
Hematology and Oncology net sales(3) |
|
|
||
Total GAAP R&D and SG&A operating expenses(4) |
|
|
||
Total Non-GAAP R&D and SG&A operating expenses(4,5) |
|
|
||
1Includes Jakafi XR™ (ruxolitinib) net sales. |
||||
2Includes net sales for moderate atopic dermatitis in |
||||
3Includes Pemazyre® (pemigatinib) in the |
||||
4Includes 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. |
||||
5Adjusted 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 profile in 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
. Star Therapeutics will be eligible to receive up to$1.25 billion in additional payments upon the achievement of sales milestones.$750 million - 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
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
|
|
Six Months Ended
|
||||||||
|
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
|
|
% Change (as reported) |
|
% Change (constant currency)1 |
|
Six Months Ended
|
|
% Change (as reported) |
|
% Change (constant currency)1 |
||||||||||||
|
2026 |
|
2025 |
|
2026 |
|
2025 |
|
|||||||||||||||
Net sales |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
Jakafi2 |
$ |
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
-
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 , primarily driven by a$817 million 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 . The increase was driven in part by a one-time, non-cash benefit of$450 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.$246 million -
Hematology and oncology net sales increased
69% in the second quarter of 2026 versus the prior year comparable period to , driven by increased demand for Niktimvo, Monjuvi/Minjuvi and Zynyz.$222 million
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 Sales1 |
|
Research and Development2 |
|
Selling, General and Administrative3 |
|
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 Sales1 |
|
Research and Development2 |
|
Selling, General and Administrative3 |
|
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 |
|
|
|
Six Months Ended June 30, 2026 |
|||||||||||||||||
|
|
Cost of Sales1 |
|
Research and Development2 |
|
Selling, General and Administrative3 |
|
Operating Income |
|
Net Income |
|||||||||
GAAP (as reported) |
|
$ |
209,480 |
|
|
$ |
1,032,853 |
|
|
$ |
679,822 |
|
|
$ |
999,015 |
|
$ |
888,935 |
|
Adjustments - Add / (Subtract) |
|
|
|
|
|
|
|
|
|
|
|||||||||
Non-cash stock compensation from equity awards |
|
|
(1,814 |
) |
|
|
(77,409 |
) |
|
|
(52,166 |
) |
|
|
131,389 |
|
|
131,389 |
|
Amortization of acquired product rights |
|
|
(10,768 |
) |
|
|
— |
|
|
|
— |
|
|
|
10,768 |
|
|
10,768 |
|
Loss on change in fair value of contingent consideration |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
2,331 |
|
|
2,331 |
|
Asset impairment and related disposal costs |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
23,214 |
|
|
23,214 |
|
Non-cash interest |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
163 |
|
(Gain) on equity investments |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
(16,396 |
) |
Tax effect of Non-GAAP pre-tax adjustments |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
(22,618 |
) |
Non-GAAP (as adjusted) |
|
$ |
196,898 |
|
|
$ |
955,444 |
|
|
$ |
627,656 |
|
|
$ |
1,166,717 |
|
$ |
1,017,786 |
|
|
|
Six Months Ended June 30, 2025 |
||||||||||||||||||
|
|
Cost of Sales1 |
|
Research and Development2 |
|
Selling, General and Administrative3 |
|
Operating Income |
|
Net Income |
||||||||||
GAAP (as reported) |
|
$ |
151,954 |
|
|
$ |
932,196 |
|
|
$ |
656,713 |
|
|
$ |
735,482 |
|
|
$ |
563,202 |
|
Adjustments - Add / (Subtract) |
|
|
|
|
|
|
|
|
|
|
||||||||||
Non-cash stock compensation from equity awards |
|
|
(1,697 |
) |
|
|
(74,424 |
) |
|
|
(49,470 |
) |
|
|
125,591 |
|
|
|
125,591 |
|
Contract dispute settlement |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(242,251 |
) |
|
|
(242,251 |
) |
Amortization of acquired product rights |
|
|
(10,768 |
) |
|
|
— |
|
|
|
— |
|
|
|
10,768 |
|
|
|
10,768 |
|
Loss on change in fair value of contingent consideration |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
34,333 |
|
|
|
34,333 |
|
Escient acquisition related compensation expense |
|
|
— |
|
|
|
(2,117 |
) |
|
|
(180 |
) |
|
|
2,297 |
|
|
|
2,297 |
|
Non-cash interest |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
163 |
|
Loss on equity investments |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
5,494 |
|
Tax effect of Non-GAAP pre-tax adjustments |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
41,789 |
|
Non-GAAP (as adjusted) |
|
$ |
139,489 |
|
|
$ |
855,655 |
|
|
$ |
607,063 |
|
|
$ |
666,220 |
|
|
$ |
541,386 |
|
1 Non-GAAP cost of sales excludes the amortization of licensed intellectual property for Iclusig relating to the acquisition of the European business of ARIAD Pharmaceuticals, Inc. and the cost of stock-based compensation. |
||||||||||||||||||||
2 Non-GAAP research and development expenses exclude the cost of stock-based compensation and Escient acquisition related compensation expense related to severance payments. |
||||||||||||||||||||
3 Non-GAAP selling, general and administrative expenses exclude the cost of stock-based compensation and Escient acquisition related compensation expense related to severance payments. |
||||||||||||||||||||
Cost of sales GAAP and Non-GAAP cost of sales for the quarter ended June 30, 2026 were
Contract dispute settlement In May 2025, Incyte and Novartis entered into a settlement agreement with respect to litigation relating to the duration of royalty payments owed under the Collaboration and License Agreement between Incyte and Novartis. Under the settlement agreement, the royalty rate payable by Incyte on future net sales of Jakafi in the United Stated is reduced by
Research and development expenses GAAP and Non-GAAP research and development expenses for the quarter ended June 30, 2026 were
Selling, general and administrative expenses GAAP and Non-GAAP selling, general and administrative expenses for the quarter ended June 30, 2026 were
Other Financial Information
Change in fair value of acquisition-related contingent consideration The change in fair value of contingent consideration during the quarter ended June 30, 2026, compared to the same period in 2025, was primarily due to updated projections of future net sales of Iclusig, including the impacts from fluctuations in foreign currency exchange rates.
Operating income GAAP and Non-GAAP operating income for the quarter ended June 30, 2026 increased
Cash, cash equivalents and marketable securities position Cash, cash equivalents and marketable securities as of June 30, 2026, were
Conference Call and Webcast Information
Incyte will hold a conference call and webcast this morning at 8:00 a.m. ET. To access the conference call, please dial 877-407-3042 for domestic callers or 201-389-0864 for international callers. When prompted, provide the conference identification number, 13759527.
If you are unable to participate, a replay of the conference call will be available for 90 days. The replay dial-in number for
The conference call will also be webcast live and can be accessed at investor.incyte.com.
About Incyte®
Incyte is redefining what’s possible in biopharmaceutical innovation. Through deep scientific expertise and a relentless focus on patients, we have built an established portfolio of first-in-class medicines and an extensive portfolio of next-generation medicines across our key franchises: Hematology, Oncology and Inflammation and Autoimmunity.
To learn more, visit Incyte.com and Investor.Incyte.com. Follow us on social media: LinkedIn, X and Instagram.
Incyte is a registered trademark of Incyte.
About Jakafi® (ruxolitinib)
Jakafi® (ruxolitinib) is a JAK1/JAK2 inhibitor approved for use in the
Jakafi is a registered trademark of Incyte.
About Jakafi XR™ (ruxolitinib) Extended-Release Tablets
Jakafi XR™ (ruxolitinib) extended-release tablets are a once-daily (QD) formulation of ruxolitinib, approved for use in the
It is not known if Jakafi XR is safe or effective in children for the treatment of MF or PV.
Jakafi XR and the Jakafi XR logo are trademarks of Incyte.
About Opzelura® (ruxolitinib) Cream
Opzelura® (ruxolitinib) cream, a novel cream formulation of Incyte’s JAK1/JAK2 inhibitor ruxolitinib, is the first and only treatment for repigmentation approved for use in the
In
Incyte has worldwide rights for the development and commercialization of Opzelura.
Opzelura is a registered trademark of Incyte.
About Monjuvi® (tafasitamab-cxix)/Minjuvi® (tafasitamab)
Monjuvi® (tafasitamab-cxix)/Minjuvi® (tafasitamab) is a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody. Tafasitamab incorporates an XmAb® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). Incyte licenses exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc.
In the
Monjuvi is not indicated and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials.
Additionally, Monjuvi received approval in the
In
In
XmAb is a registered trademark of Xencor, Inc.
Monjuvi and Minjuvi are registered trademarks of Incyte.
About Pemazyre® (pemigatinib)
Pemazyre® (pemigatinib) is a kinase inhibitor approved for use in the
Pemazyre is also the first targeted treatment approved for use in the
In
In
Pemazyre is a potent, selective, oral inhibitor of FGFR isoforms 1, 2 and 3 that has demonstrated selective pharmacologic activity against cancer cells with FGFR alterations.
Pemazyre is marketed by Incyte in
Pemazyre is a trademark of Incyte.
About Iclusig® (ponatinib) tablets
Iclusig® (ponatinib) targets not only native BCR-ABL, an abnormal, fused gene and protein associated with several types of leukemia, most notably Chronic Myeloid Leukemia (CML) and
In
Incyte has an exclusive license from Takeda Pharmaceuticals International AG to commercialize ponatinib in the European Union and 29 other countries, including
About Zynyz® (retifanlimab-dlwr)
Zynyz® (retifanlimab-dlwr) is a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), approved for use in the
Zynyz is also approved for use as monotherapy for the first-line treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC) in the
Incyte licenses exclusive worldwide rights to develop and commercialize Zynyz from MacroGenics, Inc.
Zynyz is a registered trademark of Incyte.
About Niktimvo™ (axatilimab-csfr)
Niktimvo™ (axatilimab-csfr) is a first-in-class colony stimulating factor-1 receptor (CSF-1R)-blocking antibody approved for use in the U.S. for the treatment of chronic GVHD after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg (88.2 lbs).
In September 2021, Syndax Pharmaceuticals, Inc. and Incyte entered into an exclusive worldwide co-development and co-commercialization license agreement for axatilimab in chronic GVHD and any future indications.
Axatilimab is being studied in frontline combination trials in chronic GVHD – a Phase 2 combination trial with ruxolitinib (NCT06388564) and a Phase 3 combination trial with steroids (NCT06585774) are underway. Axatilimab is also being studied in an ongoing Phase 2 trial in patients with idiopathic pulmonary fibrosis (NCT06132256).
Niktimvo is a trademark of Incyte.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding Incyte’s expected financial and operational performance; Incyte’s updated 2026 full year financial guidance; expectations regarding the impact of Incyte’s agreement with CMS pertaining to Opzelura; Incyte’s ability to deliver sustained long-term growth; the strength of Incyte’s core business and marketed products; the potential and progress of programs in Incyte’s pipeline; expectations regarding clinical trials to be initiated, ongoing clinical trials and anticipated data readouts, including for Niktimvo (axatilimab), INCA033989 (mutCALR), latarcibart, INCB161734 (KRASG12D), INCA33890 (TGFβR2xPD-1), INCB123667 (CDK2), Opzelura (ruxolitinib) cream and povorcitinib; expectations regarding regulatory submissions, regulatory approvals and launches, including for Monjuvi in newly diagnosed DLBCL and Opzelura in moderate atopic dermatitis in Europe; expectations regarding Incyte’s partnerships and collaborations; and Incyte’s aspirations and goals as set forth under the heading “About Incyte.”
Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including the sufficiency of clinical trial data to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials and the ability to enroll subjects in accordance with planned schedules; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; the efficacy or safety of Incyte’s products; Incyte’s ability to achieve commercial success for its marketed products and product candidates, if approved; Incyte’s ability to obtain and maintain protection of intellectual property for its products and technology; Incyte’s reliance on third parties and partners; the acceptance of Incyte’s products in the marketplace; market competition, sales, marketing, manufacturing and distribution requirements; greater than expected expenses, including expenses relating to litigation or strategic activities; the effects of announced or unexpected price regulation or limitations on reimbursement or coverage for Incyte’s products; and those risks and uncertainties discussed in greater detail in Incyte’s reports filed with the U.S. Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2025. Incyte disclaims any intent or obligation to update these forward-looking statements.
| *In the second quarter of 2026, the Company reached an agreement with the Centers for Medicare & Medicaid Services (CMS) to resolve the Company’s litigation related to 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). In the second quarter of 2026, the Company recorded a one-time, non-cash benefit of |
|
| †INCA33890, a TGFβR2×PD-1 bispecific Biclonics antibody, is developed in collaboration with Merus (legacy partnership); Merus is now part of Genmab A/S. | |
INCYTE CORPORATION |
|||||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
|||||||||||||||
(unaudited, in thousands, except per share amounts) |
|||||||||||||||
|
Three Months Ended
|
|
Six Months Ended
|
||||||||||||
|
|
2026 |
|
|
|
2025 |
|
|
|
2026 |
|
|
|
2025 |
|
|
|
|
|
|
|
|
|
||||||||
|
GAAP |
|
GAAP |
||||||||||||
Revenues: |
|
|
|
|
|
|
|
||||||||
Net sales |
$ |
1,488,149 |
|
|
$ |
1,059,414 |
|
|
$ |
2,592,633 |
|
|
$ |
1,981,688 |
|
Product royalty revenues |
|
174,690 |
|
|
|
151,115 |
|
|
|
325,882 |
|
|
|
281,739 |
|
Milestone and contract revenues |
|
11,200 |
|
|
|
5,000 |
|
|
|
28,200 |
|
|
|
5,000 |
|
Total revenues |
|
1,674,039 |
|
|
|
1,215,529 |
|
|
|
2,946,715 |
|
|
|
2,268,427 |
|
|
|
|
|
|
|
|
|
||||||||
Costs, expenses and other: |
|
|
|
|
|
|
|
||||||||
Cost of sales (including definite-lived intangible amortization) |
|
104,957 |
|
|
|
78,766 |
|
|
|
209,480 |
|
|
|
151,954 |
|
Contract dispute settlement |
|
— |
|
|
|
(242,251 |
) |
|
|
— |
|
|
|
(242,251 |
) |
Research and development |
|
516,950 |
|
|
|
494,917 |
|
|
|
1,032,853 |
|
|
|
932,196 |
|
Selling, general and administrative |
|
351,735 |
|
|
|
331,022 |
|
|
|
679,822 |
|
|
|
656,713 |
|
Asset impairment and related disposal costs |
|
— |
|
|
|
— |
|
|
|
23,214 |
|
|
|
— |
|
Loss on change in fair value of acquisition-related contingent consideration |
|
2,499 |
|
|
|
22,761 |
|
|
|
2,331 |
|
|
|
34,333 |
|
Total costs, expenses and other |
|
976,141 |
|
|
|
685,215 |
|
|
|
1,947,700 |
|
|
|
1,532,945 |
|
|
|
|
|
|
|
|
|
||||||||
Income from operations |
|
697,898 |
|
|
|
530,314 |
|
|
|
999,015 |
|
|
|
735,482 |
|
Interest income |
|
38,118 |
|
|
|
25,136 |
|
|
|
71,805 |
|
|
|
48,065 |
|
Interest expense |
|
(582 |
) |
|
|
(594 |
) |
|
|
(1,151 |
) |
|
|
(1,254 |
) |
Gain (loss) on equity investments |
|
9,805 |
|
|
|
(4,151 |
) |
|
|
16,396 |
|
|
|
(5,494 |
) |
Other, net |
|
6,275 |
|
|
|
7,307 |
|
|
|
9,049 |
|
|
|
15,403 |
|
Income before provision for income taxes |
|
751,514 |
|
|
|
558,012 |
|
|
|
1,095,114 |
|
|
|
792,202 |
|
Provision for income taxes |
|
165,909 |
|
|
|
153,013 |
|
|
|
206,179 |
|
|
|
229,000 |
|
Net income |
$ |
585,605 |
|
|
$ |
404,999 |
|
|
$ |
888,935 |
|
|
$ |
563,202 |
|
|
|
|
|
|
|
|
|
||||||||
Net income per share: |
|
|
|
|
|
|
|
||||||||
Basic |
$ |
2.92 |
|
|
$ |
2.09 |
|
|
$ |
4.45 |
|
|
$ |
2.91 |
|
Diluted |
$ |
2.81 |
|
|
$ |
2.04 |
|
|
$ |
4.28 |
|
|
$ |
2.84 |
|
|
|
|
|
|
|
|
|
||||||||
Shares used in computing net income per share: |
|
|
|
|
|
|
|
||||||||
Basic |
|
200,378 |
|
|
|
193,995 |
|
|
|
199,860 |
|
|
|
193,853 |
|
Diluted |
|
208,216 |
|
|
|
198,744 |
|
|
|
207,670 |
|
|
|
198,526 |
|
INCYTE CORPORATION |
|||||
CONDENSED CONSOLIDATED BALANCE SHEETS |
|||||
(unaudited, in thousands) |
|||||
|
June 30,
|
|
December 31,
|
||
ASSETS |
|
|
|
||
Cash, cash equivalents and marketable securities |
$ |
4,535,740 |
|
$ |
3,580,604 |
Accounts receivable |
|
1,125,203 |
|
|
1,024,407 |
Property and equipment, net |
|
709,469 |
|
|
730,885 |
Finance lease right-of-use assets, net |
|
25,559 |
|
|
27,520 |
Inventory |
|
457,568 |
|
|
443,292 |
Prepaid expenses and other assets |
|
341,662 |
|
|
337,849 |
Equity investments |
|
104,387 |
|
|
47,991 |
Other intangible assets, net |
|
103,196 |
|
|
117,131 |
Goodwill |
|
133,000 |
|
|
133,000 |
Deferred income tax asset |
|
336,863 |
|
|
515,294 |
Total assets |
$ |
7,872,647 |
|
$ |
6,957,973 |
|
|
|
|
||
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
||
Accounts payable, accrued expenses and other liabilities |
$ |
1,393,541 |
|
$ |
1,634,780 |
Finance lease liabilities |
|
32,679 |
|
|
34,715 |
Acquisition-related contingent consideration |
|
102,000 |
|
|
121,000 |
Stockholders’ equity |
|
6,344,427 |
|
|
5,167,478 |
Total liabilities and stockholders’ equity |
$ |
7,872,647 |
|
$ |
6,957,973 |
INCYTE CORPORATION |
|||||||||||||||
RECONCILIATION OF GAAP NET INCOME TO SELECTED NON-GAAP ADJUSTED INFORMATION |
|||||||||||||||
(unaudited, in thousands, except per share amounts) |
|||||||||||||||
|
Three Months Ended
|
|
Six Months Ended
|
||||||||||||
|
|
2026 |
|
|
|
2025 |
|
|
|
2026 |
|
|
|
2025 |
|
GAAP Net Income |
$ |
585,605 |
|
|
$ |
404,999 |
|
|
$ |
888,935 |
|
|
$ |
563,202 |
|
Adjustments1: |
|
|
|
|
|
|
|
||||||||
Non-cash stock compensation from equity awards (R&D)2 |
|
38,189 |
|
|
|
37,700 |
|
|
|
77,409 |
|
|
|
74,424 |
|
Non-cash stock compensation from equity awards (SG&A)2 |
|
28,142 |
|
|
|
26,071 |
|
|
|
52,166 |
|
|
|
49,470 |
|
Non-cash stock compensation from equity awards (COGS)2 |
|
932 |
|
|
|
838 |
|
|
|
1,814 |
|
|
|
1,697 |
|
Non-cash interest3 |
|
81 |
|
|
|
81 |
|
|
|
163 |
|
|
|
163 |
|
(Gain) loss on equity investments4 |
|
(9,805 |
) |
|
|
4,151 |
|
|
|
(16,396 |
) |
|
|
5,494 |
|
Amortization of acquired product rights5 |
|
5,384 |
|
|
|
5,384 |
|
|
|
10,768 |
|
|
|
10,768 |
|
Loss on change in fair value of contingent consideration6 |
|
2,499 |
|
|
|
22,761 |
|
|
|
2,331 |
|
|
|
34,333 |
|
Asset impairment and related disposal costs7 |
|
— |
|
|
|
— |
|
|
|
23,214 |
|
|
|
— |
|
Contract dispute settlement |
|
— |
|
|
|
(242,251 |
) |
|
|
— |
|
|
|
(242,251 |
) |
Escient acquisition related compensation expense8 |
|
— |
|
|
|
1,762 |
|
|
|
— |
|
|
|
2,297 |
|
Tax effect of Non-GAAP pre-tax adjustments9 |
|
(7,668 |
) |
|
|
50,431 |
|
|
|
(22,618 |
) |
|
|
41,789 |
|
Non-GAAP Net Income |
$ |
643,359 |
|
|
$ |
311,927 |
|
|
$ |
1,017,786 |
|
|
$ |
541,386 |
|
|
|
|
|
|
|
|
|
||||||||
Non-GAAP net income per share: |
|
|
|
|
|
|
|
||||||||
Basic |
$ |
3.21 |
|
|
$ |
1.61 |
|
|
$ |
5.09 |
|
|
$ |
2.79 |
|
Diluted |
$ |
3.09 |
|
|
$ |
1.57 |
|
|
$ |
4.90 |
|
|
$ |
2.73 |
|
|
|
|
|
|
|
|
|
||||||||
Shares used in computing Non-GAAP net income per share: |
|
|
|
|
|
|
|
||||||||
Basic |
|
200,378 |
|
|
|
193,995 |
|
|
|
199,860 |
|
|
|
193,853 |
|
Diluted |
|
208,216 |
|
|
|
198,744 |
|
|
|
207,670 |
|
|
|
198,526 |
|
1 Included within the Milestone and contract revenues line item in the Condensed Consolidated Statements of Operations (in thousands) for the three and six months ended June 30, 2026 are milestones of |
|||||||||||||||
2 As included within the Cost of sales (including definite-lived intangible amortization) line item; the Research and development expenses line item; and the Selling, general and administrative expenses line item in the Condensed Consolidated Statements of Operations. |
|||||||||||||||
3 As included within the Interest expense line item in the Condensed Consolidated Statements of Operations. |
|||||||||||||||
4 As included within the (Gain) loss on equity investments line item in the Condensed Consolidated Statements of Operations. |
|||||||||||||||
5 As included within the Cost of sales (including definite-lived intangible amortization) line item in the Condensed Consolidated Statements of Operations. Acquired product rights of licensed intellectual property for Iclusig is amortized utilizing a straight-line method over the estimated useful life of 12.5 years. |
|||||||||||||||
6 As included within the Loss on change in fair value of acquisition-related contingent consideration line item in the Condensed Consolidated Statements of Operations. |
|||||||||||||||
7 As included within the Asset impairment and related disposal costs line item in the Condensed Consolidated Statements of Operations. |
|||||||||||||||
8 Included within the Research and development line item in the Condensed Consolidated Statements of Operations (in thousands) is |
|||||||||||||||
9 Income tax effects of Non-GAAP pre-tax adjustments are calculated using an estimated annual effective tax rate, taking into consideration any permanent items and valuation allowances against related deferred tax assets. |
|||||||||||||||
View source version on businesswire.com: https://www.businesswire.com/news/home/20260728733422/en/
Media
media@incyte.com
Investors
ir@incyte.com
Source: Incyte