Incyte Reports Third Quarter 2026 Financial Results and Provides Business Updates
Total revenue of
Jakafi®/Jakafi XR™ (ruxolitinib) net sales of
Continued growth in core business (ex-Jakafi), with Opzelura® (ruxolitinib) cream net sales of
Raising 2026 full year financial guidance for Opzelura net sales, Hematology and Oncology net sales and total net sales
Phase 1 data for INCB161734 and INCA033890 support an expanding GI Oncology development strategy, including multiple ongoing and planned registrational studies in 2027
Advancing multiple registrational programs in Hematology with Phase 3 studies underway or planned for INCA033989 in essential thrombocythemia (ET) and myelofibrosis (MF), and latarcibart in von Willebrand disease (VWD)
Phase 3 data expected by year-end for povorcitinib in prurigo nodularis (PN) and ruxolitinib cream in hidradenitis suppurativa (HS)
Conference Call and Webcast Scheduled Today at
“Our third quarter was marked by strong commercial performance, meaningful pipeline progress and important regulatory achievements,” said
Third Quarter 2026 Results
-
Total revenue: Total revenue was
$1.56 billion , an increase of 14% compared to the third quarter of 2025, primarily driven by an increase in total net sales across marketed products. -
Total net sales: Total net sales were
$1.32 billion , an increase of 14% compared to the third quarter of 2025, driven by increased demand across marketed products.-
Jakafi®/Jakafi XR™ (ruxolitinib) net sales of
$827 million , an increase of 4% compared to the same period in 2025. -
Opzelura® (ruxolitinib) cream net sales of
$255 million , an increase of 36% versus the prior year period. -
Hematology and Oncology portfolio net sales of
$235 million , an increase of 38% compared to the third quarter of 2025.
-
Jakafi®/Jakafi XR™ (ruxolitinib) net sales of
-
Cost of sales: GAAP and non-GAAP cost of sales were
$108.7 million and$102.2 million , respectively, representing 8% of total net sales. -
Research and development (R&D) expenses: GAAP and non-GAAP R&D expenses were
$1.79 billion and$1.75 billion , an increase of 254% and 274%, respectively, compared to the prior year period, primarily driven by a one-time$1.23 billion IPR&D expense related to the acquisition of Vega Therapeutics. Excluding the Vega IPR&D expense, GAAP research and development expenses increased 11% as compared to the same period in 2025 primarily driven by late-stage development efforts. -
Selling, general and administrative (SG&A) expenses: GAAP and non-GAAP SG&A expenses were
$364.3 million and$339.1 million , an increase of 11% and 10%, respectively, compared to the prior year period. -
Cash, cash equivalents and marketable securities position: As of
September 30, 2026 andDecember 31, 2025 , cash, cash equivalents and marketable securities totaled$3.9 billion and$3.6 billion , respectively.
2026 Financial Guidance
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) |
Unchanged |
|
|
Total Non-GAAP R&D and SG&A operating expenses(4,5) |
Unchanged |
|
|
1 |
Includes Jakafi and Jakafi XR™ (ruxolitinib) net sales. |
|
2 |
Includes a one-time |
|
3 |
Includes Pemazyre® (pemigatinib) in the |
|
4 |
Includes upfront cost related to the acquisition of Vega Therapeutics, which was recognized as a |
|
5 |
Adjusted to exclude the estimated cost of stock-based compensation. |
Key Business Updates
Hematology
INCA033989 (mutCALR)
-
A Phase 3 study (EXCALIBUR-MF2) is expected to initiate by year end 2026, following positive End-of-Phase 2 interactions with the
U.S. Food and Drug Administration (FDA ) in the third quarter. The trial will evaluate INCA033989 versus best available therapy (BAT) in patients with CALR-mutated myelofibrosis (MF) who were previously treated with a JAK inhibitor. - The registrational Phase 3 study (EXCALIBUR-ET2), evaluating INCA033989 in mutCALR positive patients with essential thrombocythemia (ET) who are resistant or intolerant to at least one prior cytoreductive therapy was initiated in mid-2026.
- Data from the Phase 1 cohort evaluating INCA033989 as a monotherapy and in combination with ruxolitinib in treatment naïve patients with MF are anticipated in the fourth quarter of 2026.
Latarcibart (formerly VGA039)
- The Phase 3 study (VIVID-6) evaluating once-monthly subcutaneous (SC) administration of latarcibart as bleeding prophylaxis in patients with all types of von Willebrand disease (VWD) is ongoing. Topline data from the VIVID-6 study are anticipated in early 2029.
Monjuvi/Minjuvi
-
Global regulatory submissions for Monjuvi/Minjuvi as a treatment for patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) are under regulatory review. The Company anticipates a potential approval and launch in the
U.S . in the first quarter of 2027.
Niktimvo
- Results from the Phase 2 trial evaluating axatilimab in combination with ruxolitinib in patients with newly diagnosed chronic GVHD are expected to be presented at a medical meeting in the first quarter of 2027.
Oncology
INCB161734 (KRAS G12D)
-
Data from the ongoing Phase 1 trial presented at the 2026
European Society for Medical Oncology (ESMO) Congress demonstrated high response rates and early evidence of durable clinical benefit with INCB161734 in combination with standard-of-care chemotherapy (mFOLFIRINOX or GEMNabP) as a first-line treatment in patients with metastatic pancreatic ductal adenocarcinoma (PDAC), further supporting its potential as a first-line treatment option. - A Phase 3 study (DAWN-303) evaluating INCB161734 in combination with standard-of-care chemotherapy versus chemotherapy alone as a first-line treatment in patients with metastatic PDAC is ongoing, with topline data anticipated in 2028.
- A Phase 3 study evaluating INCB161734 as adjuvant therapy following surgical resection in patients with PDAC is expected to initiate in 2027.
- Data from the ongoing Phase 1 trial presented at ESMO demonstrated notable antitumor activity with INCB161734, both as monotherapy and in combination with cetuximab, in heavily pretreated metastatic colorectal cancer (CRC) patients, supporting further development in this patient population.
- A Phase 3 study (DAWN-302) evaluating INCB161734 in combination with cetuximab in patients with previously treated CRC is expected to initiate in the first half of 2027.
INCA33890 (TGFβR2xPD-1)†
-
Data from the ongoing Phase 1 trial presented at the 2026
ESMO Congress demonstrated encouraging clinical activity and a manageable safety profile of INCA33890 in combination with standard-of-care (SoC) chemotherapy and bevacizumab in first-line microsatellite-stable colorectal cancer (MSS CRC), supporting the ongoing Phase 3 study (NEXERA-303) and expansion of the program into earlier-stage disease. - The Phase 3 study (NEXERA-303) evaluating INCA33890 in combination with SoC chemotherapy and bevacizumab as a first-line treatment in patients with MSS CRC is ongoing, with topline data anticipated in 2029.
- In October, a Phase 2 study (NEXERA-204) evaluating INCA33890 for the treatment of patients with circulating tumor DNA-positive stage II/III MSS CRC after curative resection and chemotherapy, was initiated.
INCB123667 (CDK2)
- As part of a strategic shift in focus toward the first-line maintenance ovarian cancer setting, enrollment in the Phase 3 study (MAESTRA-2) evaluating INCB123667 in patients with platinum-resistant ovarian cancer (PROC) was discontinued.
- A Phase 3 study (MAESTRA-3) evaluating INCB123667 in combination with bevacizumab as first-line maintenance therapy in patients with ovarian cancer is expected to initiate in the fourth quarter 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) were presented as a rapid oral presentation at the 2026
ESMO Congress .
Inflammation and Autoimmunity (IAI)
Opzelura
-
In July, the
European Commission (EC) approved Opzelura for the treatment of moderate atopic dermatitis (AD) in adult patients for whom topical corticosteroids (TCSs) and topical calcineurin inhibitors (TCIs) are inadequate or inappropriate. Opzelura is the first steroid-free topical JAK inhibitor approved in the European Union (EU) for adults with moderate AD. This approval represents Opzelura’s second approved indication in the EU. - Topline results from the Phase 3 studies (TRuE-HS1 and TRuE-HS2) evaluating ruxolitinib cream in patients with mild to moderate hidradenitis suppurativa (HS) are anticipated in the fourth quarter of 2026.
Povorcitinib
- In September, the Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending the approval of povorcitinib (Povofortay®) for the treatment of active moderate to severe HS in adults who have responded inadequately to, or who are intolerant or contraindicated to, an anti-TNF therapy. A regulatory decision from the EC is anticipated in the fourth quarter of 2026.
-
The New Drug Application (NDA) for povorcitinib as a treatment for patients with moderate to severe HS is under regulatory review and the Company anticipates a potential
U.S . approval and launch in the first quarter of 2027. - 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 patients with asthma are anticipated by year-end 2026.
Corporate Updates
-
In July, the Company completed its acquisition of
Vega Therapeutics, Inc ., a wholly owned subsidiary ofStar Therapeutics, LLC . The acquisition added latarcibart, a novel investigational monoclonal antibody in Phase 3 development for patients with VWD, to Incyte’s 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 August, the Company entered into an agreement with the
U.S. Centers for Medicare & Medicaid Services (CMS) intended to improve access to medicines for American patients while supporting continuedU.S . biopharmaceutical innovation. Under the agreement, the Company 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. Additionally, the Company expects that it will not be subject to certain future CMS pricing mandates, including the proposed GUARD and GLOBE models.
2026 Third Quarter Financial Results
The financial measures presented in this press release for the three and nine months ended
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
|
|
Nine Months Ended
|
|||||||||
|
|
|
2026 |
|
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
Total GAAP revenues |
$ |
1,557,204 |
|
|
$ |
1,365,980 |
|
$ |
4,503,919 |
|
$ |
3,634,407 |
|
|
|
|
|
|
|
|
|
|||||
|
Total GAAP operating (loss) income |
|
(708,361 |
) |
|
|
443,518 |
|
|
290,654 |
|
|
1,179,000 |
|
Total Non-GAAP operating (loss) income |
|
(629,721 |
) |
|
|
498,296 |
|
|
536,996 |
|
|
1,164,516 |
|
|
|
|
|
|
|
|
|
|||||
|
GAAP net (loss) income |
|
(784,803 |
) |
|
|
424,169 |
|
|
104,132 |
|
|
987,371 |
|
Non-GAAP net (loss) income |
|
(730,803 |
) |
|
|
455,972 |
|
|
286,983 |
|
|
997,358 |
|
|
|
|
|
|
|
|
|
|||||
|
GAAP basic EPS |
$ |
(3.86 |
) |
|
$ |
2.17 |
|
$ |
0.52 |
|
$ |
5.08 |
|
Non-GAAP basic EPS |
$ |
(3.60 |
) |
|
$ |
2.33 |
|
$ |
1.43 |
|
$ |
5.13 |
|
GAAP diluted EPS1 |
$ |
(3.86 |
) |
|
$ |
2.11 |
|
$ |
0.50 |
|
$ |
4.95 |
|
Non-GAAP diluted EPS1 |
$ |
(3.60 |
) |
|
$ |
2.26 |
|
$ |
1.37 |
|
$ |
5.00 |
|
1. All stock options and stock awards were excluded from the diluted share calculation for the three months ended |
Revenue Details
|
Revenue Details |
|||||||||||||||||||||||
|
(unaudited, in thousands) |
|||||||||||||||||||||||
|
|
Three Months Ended
|
|
%
|
|
%
|
|
Nine Months Ended
|
|
%
|
|
%
|
||||||||||||
|
|
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
|||||||||||
|
Net sales |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
|
Jakafi2 |
$ |
826,501 |
|
$ |
791,071 |
|
4 |
% |
|
NA |
|
$ |
2,400,915 |
|
$ |
2,264,271 |
|
6 |
% |
|
NA |
||
|
Opzelura3 |
|
254,880 |
|
|
187,968 |
|
36 |
% |
|
36 |
% |
|
|
847,631 |
|
|
471,172 |
|
80 |
% |
|
79 |
% |
|
Iclusig |
|
33,527 |
|
|
37,582 |
|
(11 |
%) |
|
(10 |
%) |
|
|
103,384 |
|
|
99,855 |
|
4 |
% |
|
(0.2 |
%) |
|
Pemazyre |
|
21,179 |
|
|
22,741 |
|
(7 |
%) |
|
(6 |
%) |
|
|
67,140 |
|
|
63,373 |
|
6 |
% |
|
5 |
% |
|
Minjuvi/Monjuvi |
|
54,630 |
|
|
41,990 |
|
30 |
% |
|
32 |
% |
|
|
157,543 |
|
|
102,672 |
|
53 |
% |
|
53 |
% |
|
Niktimvo |
|
67,368 |
|
|
45,830 |
|
47 |
% |
|
47 |
% |
|
|
182,765 |
|
|
95,597 |
|
91 |
% |
|
91 |
% |
|
Zynyz |
|
58,328 |
|
|
22,674 |
|
157 |
% |
|
158 |
% |
|
|
149,668 |
|
|
34,604 |
|
333 |
% |
|
331 |
% |
|
Total net sales |
|
1,316,413 |
|
|
1,149,856 |
|
14 |
% |
|
15 |
% |
|
|
3,909,046 |
|
|
3,131,544 |
|
25 |
% |
|
25 |
% |
|
Royalty revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
|
Jakavi |
|
132,458 |
|
|
125,645 |
|
5 |
% |
|
6 |
% |
|
|
362,204 |
|
|
327,504 |
|
11 |
% |
|
7 |
% |
|
Olumiant |
|
39,052 |
|
|
37,111 |
|
5 |
% |
|
8 |
% |
|
|
113,938 |
|
|
101,393 |
|
12 |
% |
|
12 |
% |
|
Tabrecta |
|
6,833 |
|
|
6,513 |
|
5 |
% |
|
NA |
|
|
19,506 |
|
|
19,558 |
|
(0.3 |
%) |
|
NA |
||
|
Other |
|
12,648 |
|
|
1,855 |
|
582 |
% |
|
NA |
|
|
21,225 |
|
|
4,408 |
|
382 |
% |
|
NA |
||
|
Total royalty revenues |
|
190,991 |
|
|
171,124 |
|
12 |
% |
|
|
|
|
516,873 |
|
|
452,863 |
|
14 |
% |
|
|
||
|
Total net sales and royalty revenues |
|
1,507,404 |
|
|
1,320,980 |
|
14 |
% |
|
|
|
|
4,425,919 |
|
|
3,584,407 |
|
23 |
% |
|
|
||
|
Milestone and contract revenues |
|
49,800 |
|
|
45,000 |
|
11 |
% |
|
11 |
% |
|
|
78,000 |
|
|
50,000 |
|
56 |
% |
|
56 |
% |
|
Total GAAP revenues |
$ |
1,557,204 |
|
$ |
1,365,980 |
|
14 |
% |
|
|
|
$ |
4,503,919 |
|
$ |
3,634,407 |
|
24 |
% |
|
|
||
|
NA = not applicable |
|
|
1 |
Percentage change in constant currency is calculated using 2025 foreign exchange rates to recalculate 2026 results. |
|
2 |
2026 Jakafi net sales include Jakafi and Jakafi XR following the launch of Jakafi XR in the second quarter of 2026. |
|
3 |
Opzelura net sales for the nine months ended |
-
Total net sales for the quarter ended
September 30, 2026 increased 14% over the prior year comparable period. -
Jakafi net sales increased 4% in the third quarter of 2026 versus the prior year comparable period to
$827 million , primarily driven by a 12% increase in paid demand and growth across all indications. Jakafi inventory levels were within normal range at the end of the third quarter of 2026. -
Opzelura net sales increased 36% in the third quarter of 2026 versus the prior year comparable period to
$255 million . Net growth was driven by increased patient demand in both AD and vitiligo and improvements in net pricing resulting from the Opzelura line extension settlement in the second quarter. Opzelura inventory levels were within normal range at the end of the third quarter of 2026. -
Hematology and oncology net sales increased 38% in the third quarter of 2026 versus the prior year comparable period to
$235 million , driven by increased demand for Niktimvo, Zynyz and Monjuvi/Minjuvi.
Operating Expenses
|
Reconciliation of Reported to Adjusted Results |
||||||||||||||||||||
|
(unaudited, in thousands) |
||||||||||||||||||||
|
|
|
Three Months Ended |
||||||||||||||||||
|
|
|
Cost of
|
|
Research and
|
|
Selling, General
|
|
Operating
|
|
Net (Loss)
|
||||||||||
|
GAAP (as reported) |
|
$ |
108,744 |
|
|
$ |
1,791,656 |
|
|
$ |
364,273 |
|
|
$ |
(708,361 |
) |
|
$ |
(784,803 |
) |
|
Adjustments - Add / (Subtract) |
|
|
|
|
|
|
|
|
|
|
||||||||||
|
Non-cash stock compensation from equity awards |
|
|
(1,160 |
) |
|
|
(43,503 |
) |
|
|
(25,130 |
) |
|
|
69,793 |
|
|
|
69,793 |
|
|
Amortization of acquired product rights |
|
|
(5,384 |
) |
|
|
— |
|
|
|
— |
|
|
|
5,384 |
|
|
|
5,384 |
|
|
Loss on change in fair value of contingent consideration |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
892 |
|
|
|
892 |
|
|
Vega acquisition transition costs and related compensation expenses |
|
|
— |
|
|
|
(2,571 |
) |
|
|
— |
|
|
|
2,571 |
|
|
|
2,571 |
|
|
Non-cash interest |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
82 |
|
|
Loss on equity investments |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
13,225 |
|
|
Tax effect of Non-GAAP pre-tax adjustments |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(37,947 |
) |
|
Non-GAAP (as adjusted) |
|
$ |
102,200 |
|
|
$ |
1,745,582 |
|
|
$ |
339,143 |
|
|
$ |
(629,721 |
) |
|
$ |
(730,803 |
) |
|
|
|
Three Months Ended |
||||||||||||||||||
|
|
|
Cost of
|
|
Research and
|
|
Selling, General
|
|
Operating
|
|
Net Income |
||||||||||
|
GAAP (as reported) |
|
$ |
99,001 |
|
|
$ |
506,584 |
|
|
$ |
329,081 |
|
|
$ |
443,518 |
|
|
$ |
424,169 |
|
|
Adjustments - Add / (Subtract) |
|
|
|
|
|
|
|
|
|
|
||||||||||
|
Non-cash stock compensation from equity awards |
|
|
(923 |
) |
|
|
(39,634 |
) |
|
|
(21,041 |
) |
|
|
61,598 |
|
|
|
61,598 |
|
|
Amortization of acquired product rights |
|
|
(5,384 |
) |
|
|
— |
|
|
|
— |
|
|
|
5,384 |
|
|
|
5,384 |
|
|
(Gain) on change in fair value of contingent consideration |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(12,204 |
) |
|
|
(12,204 |
) |
|
Escient acquisition related compensation expense |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
Non-cash interest |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
82 |
|
|
(Gain) on equity investments |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(8,558 |
) |
|
Tax effect of Non-GAAP pre-tax adjustments |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(14,499 |
) |
|
Non-GAAP (as adjusted) |
|
$ |
92,694 |
|
|
$ |
466,950 |
|
|
$ |
308,040 |
|
|
$ |
498,296 |
|
|
$ |
455,972 |
|
|
|
|
Nine Months Ended |
|||||||||||||||||
|
|
|
Cost of
|
|
Research and
|
|
Selling, General
|
|
Operating
|
|
Net Income |
|||||||||
|
GAAP (as reported) |
|
$ |
318,224 |
|
|
$ |
2,824,509 |
|
|
$ |
1,044,095 |
|
|
$ |
290,654 |
|
$ |
104,132 |
|
|
Adjustments - Add / (Subtract) |
|
|
|
|
|
|
|
|
|
|
|||||||||
|
Non-cash stock compensation from equity awards |
|
|
(2,974 |
) |
|
|
(120,912 |
) |
|
|
(77,296 |
) |
|
|
201,182 |
|
|
201,182 |
|
|
Amortization of acquired product rights |
|
|
(16,152 |
) |
|
|
— |
|
|
|
— |
|
|
|
16,152 |
|
|
16,152 |
|
|
Loss on change in fair value of contingent consideration |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
3,223 |
|
|
3,223 |
|
|
Asset impairment and related disposal costs |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
23,214 |
|
|
23,214 |
|
|
Vega acquisition transition costs and related compensation expenses |
|
|
— |
|
|
|
(2,571 |
) |
|
|
— |
|
|
|
2,571 |
|
|
2,571 |
|
|
Non-cash interest |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
245 |
|
|
(Gain) on equity investments |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
(3,171 |
) |
|
Tax effect of Non-GAAP pre-tax adjustments |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
(60,565 |
) |
|
Non-GAAP (as adjusted) |
|
$ |
299,098 |
|
|
$ |
2,701,026 |
|
|
$ |
966,799 |
|
|
$ |
536,996 |
|
$ |
286,983 |
|
|
|
|
Nine Months Ended |
||||||||||||||||||
|
|
|
Cost of
|
|
Research and
|
|
Selling, General
|
|
Operating
|
|
Net Income |
||||||||||
|
GAAP (as reported) |
|
$ |
250,955 |
|
|
$ |
1,438,780 |
|
|
$ |
985,794 |
|
|
$ |
1,179,000 |
|
|
$ |
987,371 |
|
|
Adjustments - Add / (Subtract) |
|
|
|
|
|
|
|
|
|
|
||||||||||
|
Non-cash stock compensation from equity awards |
|
|
(2,620 |
) |
|
|
(114,058 |
) |
|
|
(70,511 |
) |
|
|
187,189 |
|
|
|
187,189 |
|
|
Contract dispute settlement |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(242,251 |
) |
|
|
(242,251 |
) |
|
Amortization of acquired product rights |
|
|
(16,152 |
) |
|
|
— |
|
|
|
— |
|
|
|
16,152 |
|
|
|
16,152 |
|
|
Loss on change in fair value of contingent consideration |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
22,129 |
|
|
|
22,129 |
|
|
Escient acquisition related compensation expense |
|
|
— |
|
|
|
(2,117 |
) |
|
|
(180 |
) |
|
|
2,297 |
|
|
|
2,297 |
|
|
Non-cash interest |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
245 |
|
|
(Gain) on equity investments |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(3,064 |
) |
|
Tax effect of Non-GAAP pre-tax adjustments |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
27,290 |
|
|
Non-GAAP (as adjusted) |
|
$ |
232,183 |
|
|
$ |
1,322,605 |
|
|
$ |
915,103 |
|
|
$ |
1,164,516 |
|
|
$ |
997,358 |
|
|
1 |
Non-GAAP cost of sales excludes the amortization of licensed intellectual property for Iclusig relating to the acquisition of the European business of |
|
2 |
Non-GAAP research and development expenses exclude the cost of stock-based compensation, Escient acquisition related compensation expense related to severance payments, and Vega transition costs primarily representing employee related costs to transition research and development activities to us as part of the Vega acquisition, as well as retention payments to former Vega employees. |
|
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
Contract dispute settlement In
Research and development expenses GAAP and Non-GAAP research and development expenses for the quarter ended
Selling, general and administrative expenses GAAP and Non-GAAP selling, general and administrative expenses for the quarter ended
Other Financial Information
Change in fair value of acquisition-related contingent consideration The change in fair value of contingent consideration during the quarter ended
Operating income GAAP and Non-GAAP operating income for the quarter ended
Cash, cash equivalents and marketable securities position Cash, cash equivalents and marketable securities as of
Conference Call and Webcast Information
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
To learn more, visit Incyte.com and Investor.Incyte.com. Follow us on social media: LinkedIn, X and Instagram.
About Jakafi® (ruxolitinib)
Jakafi® (ruxolitinib) is a JAK1/JAK2 inhibitor approved for use in the
Jakafi is a registered trademark of
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
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
Opzelura is a registered trademark of
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 mechanisms including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP).
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
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
Pemazyre is a trademark of
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
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
Zynyz is a registered trademark of
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.
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; Incyte’s ability to deliver sustained long-term growth and create long-term value for patients and shareholders; the strength and growth of Incyte’s core business and marketed products; the potential and progress of programs in Incyte’s pipeline, including their potential to provide significant future growth opportunities; expectations regarding the initiation, timing, progress and results of clinical trials and anticipated data readouts, including for INCA033989(mutCALR), INCB161734 (KRAS G12D inhibitor), INCA33890 (TGFβR2xPD-1 bispecific), latarcibart, Niktimvo (axatilimab), INCB123667 (CDK2), Opzelura and povorcitinib; expectations regarding regulatory submissions, regulatory decisions, approvals and commercial launches, including for Monjuvi in newly diagnosed DLBCL and povorcitinib in HS; 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; the impact of agreements or arrangements with governmental authorities relating to the pricing, reimbursement or coverage of 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, and subsequent quarterly reports filed on Form 10-Q. Incyte disclaims any intent or obligation to update these forward-looking statements.
| __________________ | |
|
† |
INCA33890, a TGFβR2×PD-1 bispecific Biclonics® antibody, is developed in collaboration with Merus (legacy partnership); Merus is now part of Genmab A/S. |
|
|
|||||||||||||||
|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
|||||||||||||||
|
(unaudited, in thousands, except per share amounts) |
|||||||||||||||
|
|
Three Months Ended
|
|
Nine Months Ended
|
||||||||||||
|
|
|
2026 |
|
|
|
2025 |
|
|
|
2026 |
|
|
|
2025 |
|
|
|
|
|
|
|
|
|
|
||||||||
|
|
GAAP |
|
GAAP |
||||||||||||
|
Revenues: |
|
|
|
|
|
|
|
||||||||
|
Net sales |
$ |
1,316,413 |
|
|
$ |
1,149,856 |
|
|
$ |
3,909,046 |
|
|
$ |
3,131,544 |
|
|
Product royalty revenues |
|
190,991 |
|
|
|
171,124 |
|
|
|
516,873 |
|
|
|
452,863 |
|
|
Milestone and contract revenues |
|
49,800 |
|
|
|
45,000 |
|
|
|
78,000 |
|
|
|
50,000 |
|
|
Total revenues |
|
1,557,204 |
|
|
|
1,365,980 |
|
|
|
4,503,919 |
|
|
|
3,634,407 |
|
|
|
|
|
|
|
|
|
|
||||||||
|
Costs, expenses and other: |
|
|
|
|
|
|
|
||||||||
|
Cost of sales (including definite-lived intangible amortization) |
|
108,744 |
|
|
|
99,001 |
|
|
|
318,224 |
|
|
|
250,955 |
|
|
Contract dispute settlement |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(242,251 |
) |
|
Research and development |
|
1,791,656 |
|
|
|
506,584 |
|
|
|
2,824,509 |
|
|
|
1,438,780 |
|
|
Selling, general and administrative |
|
364,273 |
|
|
|
329,081 |
|
|
|
1,044,095 |
|
|
|
985,794 |
|
|
Asset impairment and related disposal costs |
|
— |
|
|
|
— |
|
|
|
23,214 |
|
|
|
— |
|
|
Loss (gain) on change in fair value of acquisition-related contingent consideration |
|
892 |
|
|
|
(12,204 |
) |
|
|
3,223 |
|
|
|
22,129 |
|
|
Total costs, expenses and other |
|
2,265,565 |
|
|
|
922,462 |
|
|
|
4,213,265 |
|
|
|
2,455,407 |
|
|
|
|
|
|
|
|
|
|
||||||||
|
(Loss) income from operations |
|
(708,361 |
) |
|
|
443,518 |
|
|
|
290,654 |
|
|
|
1,179,000 |
|
|
Interest income |
|
32,174 |
|
|
|
26,781 |
|
|
|
103,979 |
|
|
|
74,846 |
|
|
Interest expense |
|
(605 |
) |
|
|
(592 |
) |
|
|
(1,756 |
) |
|
|
(1,846 |
) |
|
(Loss) gain on equity investments |
|
(13,225 |
) |
|
|
8,558 |
|
|
|
3,171 |
|
|
|
3,064 |
|
|
Other, net |
|
1,169 |
|
|
|
4,043 |
|
|
|
10,218 |
|
|
|
19,446 |
|
|
(Loss) income before provision for income taxes |
|
(688,848 |
) |
|
|
482,308 |
|
|
|
406,266 |
|
|
|
1,274,510 |
|
|
Provision for income taxes |
|
95,955 |
|
|
|
58,139 |
|
|
|
302,134 |
|
|
|
287,139 |
|
|
Net (loss) income |
$ |
(784,803 |
) |
|
$ |
424,169 |
|
|
$ |
104,132 |
|
|
$ |
987,371 |
|
|
|
|
|
|
|
|
|
|
||||||||
|
Net (loss) income per share: |
|
|
|
|
|
|
|
||||||||
|
Basic |
$ |
(3.86 |
) |
|
$ |
2.17 |
|
|
$ |
0.52 |
|
|
$ |
5.08 |
|
|
Diluted |
$ |
(3.86 |
) |
|
$ |
2.11 |
|
|
$ |
0.50 |
|
|
$ |
4.95 |
|
|
|
|
|
|
|
|
|
|
||||||||
|
Shares used in computing net (loss) income per share: |
|
|
|
|
|
|
|
||||||||
|
Basic |
|
203,246 |
|
|
|
195,670 |
|
|
|
200,989 |
|
|
|
194,459 |
|
|
Diluted |
|
203,246 |
|
|
|
201,429 |
|
|
|
208,762 |
|
|
|
199,405 |
|
|
|
|||||
|
CONDENSED CONSOLIDATED BALANCE SHEETS |
|||||
|
(unaudited, in thousands) |
|||||
|
|
|
|
|
||
|
ASSETS |
|
|
|
||
|
Cash, cash equivalents and marketable securities |
$ |
3,854,572 |
|
$ |
3,580,604 |
|
Accounts receivable |
|
1,237,027 |
|
|
1,024,407 |
|
Property and equipment, net |
|
701,101 |
|
|
730,885 |
|
Finance lease right-of-use assets, net |
|
24,690 |
|
|
27,520 |
|
Inventory |
|
475,836 |
|
|
443,292 |
|
Prepaid expenses and other assets |
|
384,949 |
|
|
337,849 |
|
Equity investments |
|
91,162 |
|
|
47,991 |
|
Other intangible assets, net |
|
103,229 |
|
|
117,131 |
|
|
|
133,000 |
|
|
133,000 |
|
Deferred income tax asset |
|
281,691 |
|
|
515,294 |
|
Total assets |
$ |
7,287,257 |
|
$ |
6,957,973 |
|
|
|
|
|
||
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
||
|
Accounts payable, accrued expenses and other liabilities |
$ |
1,520,558 |
|
$ |
1,634,780 |
|
Finance lease liabilities |
|
31,762 |
|
|
34,715 |
|
Acquisition-related contingent consideration |
|
92,000 |
|
|
121,000 |
|
Stockholders’ equity |
|
5,642,937 |
|
|
5,167,478 |
|
Total liabilities and stockholders’ equity |
$ |
7,287,257 |
|
$ |
6,957,973 |
|
|
|||||||||||||||
|
RECONCILIATION OF GAAP NET (LOSS) INCOME TO SELECTED NON-GAAP ADJUSTED INFORMATION |
|||||||||||||||
|
(unaudited, in thousands, except per share amounts) |
|||||||||||||||
|
|
Three Months Ended
|
|
Nine Months Ended
|
||||||||||||
|
|
|
2026 |
|
|
|
2025 |
|
|
|
2026 |
|
|
|
2025 |
|
|
GAAP Net (Loss) Income |
$ |
(784,803 |
) |
|
$ |
424,169 |
|
|
$ |
104,132 |
|
|
$ |
987,371 |
|
|
Adjustments1: |
|
|
|
|
|
|
|
||||||||
|
Non-cash stock compensation from equity awards (R&D)2 |
|
43,503 |
|
|
|
39,634 |
|
|
|
120,912 |
|
|
|
114,058 |
|
|
Non-cash stock compensation from equity awards (SG&A)2 |
|
25,130 |
|
|
|
21,041 |
|
|
|
77,296 |
|
|
|
70,511 |
|
|
Non-cash stock compensation from equity awards (COGS)2 |
|
1,160 |
|
|
|
923 |
|
|
|
2,974 |
|
|
|
2,620 |
|
|
Non-cash interest3 |
|
82 |
|
|
|
82 |
|
|
|
245 |
|
|
|
245 |
|
|
Loss (gain) on equity investments4 |
|
13,225 |
|
|
|
(8,558 |
) |
|
|
(3,171 |
) |
|
|
(3,064 |
) |
|
Amortization of acquired product rights5 |
|
5,384 |
|
|
|
5,384 |
|
|
|
16,152 |
|
|
|
16,152 |
|
|
Loss (gain) on change in fair value of contingent consideration6 |
|
892 |
|
|
|
(12,204 |
) |
|
|
3,223 |
|
|
|
22,129 |
|
|
Asset impairment and related disposal costs7 |
|
— |
|
|
|
— |
|
|
|
23,214 |
|
|
|
— |
|
|
Contract dispute settlement |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(242,251 |
) |
|
Escient acquisition related compensation expense8 |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
2,297 |
|
|
Vega acquisition transition costs and related compensation expenses9 |
|
2,571 |
|
|
|
— |
|
|
|
2,571 |
|
|
|
— |
|
|
Tax effect of Non-GAAP pre-tax adjustments10 |
|
(37,947 |
) |
|
|
(14,499 |
) |
|
|
(60,565 |
) |
|
|
27,290 |
|
|
Non-GAAP Net (Loss) Income |
$ |
(730,803 |
) |
|
$ |
455,972 |
|
|
$ |
286,983 |
|
|
$ |
997,358 |
|
|
|
|
|
|
|
|
|
|
||||||||
|
Non-GAAP net (loss) income per share: |
|
|
|
|
|
|
|
||||||||
|
Basic |
$ |
(3.60 |
) |
|
$ |
2.33 |
|
|
$ |
1.43 |
|
|
$ |
5.13 |
|
|
Diluted |
$ |
(3.60 |
) |
|
$ |
2.26 |
|
|
$ |
1.37 |
|
|
$ |
5.00 |
|
|
|
|
|
|
|
|
|
|
||||||||
|
Shares used in computing Non-GAAP net (loss) income per share: |
|
|
|
|
|
|
|
||||||||
|
Basic |
|
203,246 |
|
|
|
195,670 |
|
|
|
200,989 |
|
|
|
194,459 |
|
|
Diluted |
|
203,246 |
|
|
|
201,429 |
|
|
|
208,762 |
|
|
|
199,405 |
|
|
1 |
Included within the Milestone and contract revenues line item in the Condensed Consolidated Statements of Operations (in thousands) for the three and nine months ended |
|
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 Loss (gain) 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 (gain) 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 |
Included within the Research and development line item in the Condensed Consolidated Statements of Operations (in thousands) is |
|
10 |
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/20261029846124/en/
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