On February 10, 2025 Incyte (Nasdaq:INCY) reported financial results for the fourth quarter and full year ended December 31, 2024 and provided full year 2025 financial guidance (Press release, Incyte, FEB 10, 2025, View Source [SID1234650133]).
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"2024 was an important year for Incyte, with a 15% increase in total revenues, driven by strong growth from both Jakafi and Opzelura, as well as significant progress across our R&D pipeline," said Hervé Hoppenot, Chief Executive Officer, Incyte. "Looking ahead to 2025, we anticipate a year of continued strong revenue growth and diversification, as well as several defining milestones that will serve as an inflection point for Incyte. A year ago, we set the goal to achieve more than 10 impactful product launches by 2030. In 2025, a number of key catalysts across the entire portfolio will bring that goal closer to reality."
2025: A Year of Defining Catalysts
Incyte expects to deliver at least 18 key milestones in 2025. These include:
•Four new product launches: Niktimvo in 3L+ chronic graft-versus-host disease (GVHD), ruxolitinib cream in pediatric atopic dermatitis (AD), tafasitamab in relapsed/refractory follicular lymphoma (FL), and retifanlimab in squamous cell anal carcinoma (SCAC).
•At least three Phase 3 study initiations: BET inhibitor in 2L myelofibrosis (MF), ruxolitinib cream in mild to moderate hidradenitis suppurativa (HS) and CDK2 inhibitor in ovarian cancer.
•Four pivotal readouts: Povorcitinib in moderate to severe HS, ruxolitinib cream in prurigo nodularis (PN), tafasitamab in 1L diffuse large B-cell lymphoma (DLBCL), and ruxolitinib XR for MF, polycythemia vera (PV), and GVHD.
•Seven proof of concept readouts: Povorcitinib in chronic spontaneous urticaria (CSU) and asthma, mutCALR in MF and essential thrombocythemia (ET), JAK2V617F mutant-specific inhibitor in MF, and both KRASG12D and TGFβR2xPD-1 in solid tumors.
Key Recent Company Updates
•A bioequivalence study of ruxolitinib extended-release (XR) has been completed. These data are anticipated to be submitted to the U.S. Food and Drug Administration (FDA) by year-end 2025 once the stability studies are complete.
•In January 2025, Incyte and Syndax Pharmaceuticals announced that the FDA approved Niktimvo (axatilimab-csfr) in 9 mg and 22 mg vial sizes. Niktimvo is now commercially available in the U.S. and the commercial launch is underway.
•In December 2024, additional results from the pivotal Phase 3 inMIND trial evaluating treatment with tafasitamab (Monjuvi), a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, in combination with lenalidomide and rituximab compared with placebo plus lenalidomide and rituximab in patients with relapsed or refractory follicular lymphoma were featured in the late-breaking session at the 2024 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. The study met its primary endpoint by demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) by investigator assessment in 548 patients with relapsed or refractory FL. Tafasitamab was generally well-tolerated, and safety was consistent with other CD19 and immunotherapy combination regimens. These data have been submitted to the FDA and approval for this indication is expected in the second half of 2025.
•In December 2024, Incyte shared additional data from its BET inhibitor (INCB057643) in patients with relapsed or refractory myelofibrosis and other advanced myeloid neoplasms at the 2024 ASH (Free ASH Whitepaper) Annual Meeting. These results showed treatment with INCB057643 was generally well tolerated and improvements in anemia, spleen size, and symptom burden were observed in patients receiving INCB057643 monotherapy and in combination with ruxolitinib. Incyte plans to initiate a Phase 3 monotherapy study in the post Jakafi patient population in 2025.
•In December 2024, the supplemental Biologics License Application (sBLA) submission for retifanlimab (Zynyz) in advanced/metastatic squamous cell anal carcinoma was filed with the FDA with approval anticipated in the second half of 2025.
•In October 2024, the sNDA submission for ruxolitinib cream (Opzelura) in pediatric atopic dermatitis was filed with the FDA with approval anticipated in the second half of 2025.
Jakafi:
Net product revenues for the fourth quarter of 2024 of $773 million; 2024 full year net product revenues of $2.79 billion
▪Fourth quarter 2024 net product revenues increased 11% compared to the fourth quarter of 2023 and 8% for the full year 2024 when compared to 2023.
▪Net product revenues were primarily driven by paid demand, which increased 14% in the fourth quarter of 2024 and 9% for the full year 2024 when compared to the same periods in 2023, with growth across all indications.
▪Channel inventory at the end of the fourth quarter of 2024 was within the normal range.
Opzelura:
Net product revenues for the fourth quarter of 2024 of $162 million; 2024 full year net product revenues of $508 million:
▪Fourth quarter 2024 net product revenues increased 48% compared to the fourth quarter of 2023 and 50% for the full year 2024 when compared to 2023.
▪Net product revenues were primarily driven by patient demand and refills for both atopic dermatitis and vitiligo and increased contribution from Europe.
Additional Pipeline Updates
Myeloproliferative Neoplasms (MPNs) and Graft-Versus-Host Disease (GVHD) – key highlights
▪The Phase 1 studies evaluating mutCALR in myelofibrosis (MF) and essential thrombocythemia (ET) and JAK2V617Fi in MF are ongoing and enrolling patients. Initial proof of concept data for both studies are anticipated in 2025.
▪A Phase 2 trial evaluating the safety and efficacy of axatilimab (Niktimvo) in combination with ruxolitinib (Jakafi) in patients with newly diagnosed chronic GVHD was initiated in the fourth quarter of 2024 and is enrolling patients.
▪A Phase 3, randomized, double-blind, placebo-controlled, multi-center trial that will investigate the use of axatilimab in combination with corticosteroids as initial treatment for chronic GVHD has been initiated and is enrolling patients.
MPN and GVHD Programs Indication and Phase
Ruxolitinib XR (QD)
(JAK1/JAK2) Myelofibrosis, polycythemia vera and GVHD
Ruxolitinib + INCB57643
(JAK1/JAK2 + BETi) Myelofibrosis: Phase 2
Ruxolitinib + axatilimab1
(JAK1/JAK2 + anti-CSF-1R)
Chronic GVHD: Phase 2
Steroids + axatilimab1
(Steroids + anti-CSF-1R)
Chronic GVHD: Phase 3
INCA33989
(mutCALR) Myelofibrosis, essential thrombocythemia: Phase 1
INCB160058
(JAK2V617Fi) Myelofibrosis: Phase 1
1 Clinical development of axatilimab in GVHD conducted in collaboration with Syndax Pharmaceuticals.
Other Hematology/Oncology – key highlights
▪Incyte plans to initiate Phase 3 studies for its potentially first-in-class CDK2 inhibitor (INCB123667), in ovarian cancer in 2025 and is also evaluating INCB123667 in combination with other treatments.
▪The Phase 3 study evaluating tafasitamab in first-line DLBCL is ongoing. The Phase 3 data are anticipated in the first half of 2025.
▪The Phase 1 studies evaluating KRASG12D and TGFßR2×PD-1 in solid tumors are ongoing and enrolling patients. Initial proof of concept data for both studies are anticipated in 2025.
Heme/Oncology Programs Indication and Phase
Tafasitamab (Monjuvi/Minjuvi)
(CD19)
Relapsed or refractory diffuse large B-cell lymphoma (DLBCL): Phase 3 (B-MIND)
First-line DLBCL: Phase 3 (frontMIND)
Relapsed or refractory follicular lymphoma (FL): Phase 3 (inMIND)
Retifanlimab (Zynyz)1
(PD-1)
Squamous cell anal cancer (SCAC): Phase 3 (POD1UM-303)
Non-small cell lung cancer (NSCLC): Phase 3 (POD1UM-304)
MSI-high endometrial cancer: Phase 2 (POD1UM-101, POD1UM-204)
INCB123667
(CDK2i) Solid tumors with CCNE1 amplification/Cyclin E overexpression: Phase 1
INCB161734
(KRASG12D) Advanced metastatic solid tumors with a KRASG12D mutation: Phase 1
INCA33890
(TGFßR2×PD-1)2
Advanced or metastatic solid tumors: Phase 1
1 Retifanlimab licensed from MacroGenics.
2 Development in collaboration with Merus.
Inflammation and Autoimmunity (IAI) – key highlights
Ruxolitinib Cream
▪Two Phase 3 trials (TRuE-PN1 and TRuE-PN2) evaluating ruxolitinib cream in prurigo nodularis (PN) are fully enrolled. Data from the Phase 3 studies are anticipated in the first half of 2025.
▪The Phase 3 trial for ruxolitinib cream in mild to moderate hidradenitis suppurativa (HS) is on track to initiate in the first half of 2025 following achieving alignment on the study design with FDA.
▪In February 2025, Opzelura was granted approval by the Swiss Agency for Therapeutic Products (Swissmedic) for the treatment of non-segmental vitiligo with facial involvement in patients 12 years of age and older.
▪In October 2024, Opzelura was granted a Notice of Compliance by Health Canada for the topical treatment of both mild to moderate atopic dermatitis and nonsegmental vitiligo in patients 12 years of age and older.
Povorcitinib (INCB54707)
▪In October 2024, two Phase 3 studies (STOP-PN1 and STOP-PN2) evaluating povorcitinib in patients with PN versus placebo were initiated and are enrolling.
▪The Phase 3 studies of povorcitinib in patients with HS (STOP-HS1 and STOP-HS2) are fully enrolled. Data from both pivotal studies are anticipated in the first half of 2025.
▪Two Phase 2 trials evaluating povorcitinib in asthma and chronic spontaneous urticaria (CSU) are enrolling. Data for CSU are anticipated in the first half of 2025 and data in asthma are anticipated in the second half of 2025.
4
IAI and Dermatology Programs Indication and Phase
Ruxolitinib cream (Opzelura)1
(JAK1/JAK2)
Atopic dermatitis: Phase 3 pediatric study (TRuE-AD3)
Hidradenitis suppurativa: Phase 2; Phase 3 expected to initiate in 2025
Prurigo nodularis: Phase 3 (TRuE-PN1, TRuE-PN2)
Povorcitinib
(JAK1) Hidradenitis suppurativa: Phase 3 (STOP-HS1, STOP-HS2)
Vitiligo: Phase 3 (STOP-V1, STOP-V2)
Prurigo nodularis: Phase 3 (STOP-PN1, STOP-PN2)
Chronic spontaneous urticaria: Phase 2
Asthma: Phase 2
INCA034460
(anti-CD122) Vitiligo: Phase 1
1 Novartis’ rights to ruxolitinib outside of the United States under our Collaboration and License Agreement with Novartis do not include topical administration.
Other
Other Program Indication and Phase
Zilurgisertib
(ALK2) Fibrodysplasia ossificans progressiva: Pivotal Phase 2
2024 Fourth Quarter and Year-end Financial Results
The financial measures presented in this press release for the quarter and year ended December 31, 2024 and 2023 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 its 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 December 31, Twelve Months Ended December 31,
2024 2023 2024 2023
Total GAAP revenues $ 1,178,698 $ 1,013,341 $ 4,241,217 $ 3,695,649
Total GAAP operating income 301,513 187,270 61,366 620,525
Total Non-GAAP operating income 376,265 267,702 413,883 892,783
GAAP net income 201,212 201,079 32,615 597,599
Non-GAAP net income 281,353 239,124 227,591 795,449
GAAP basic EPS $ 1.04 $ 0.90 $ 0.16 $ 2.67
Non-GAAP basic EPS $ 1.46 $ 1.07 $ 1.10 $ 3.56
GAAP diluted EPS $ 1.02 $ 0.89 $ 0.15 $ 2.65
Non-GAAP diluted EPS $ 1.43 $ 1.06 $ 1.08 $ 3.52
Revenue Details
Revenue Details
(unaudited, in thousands)
Three Months Ended December 31, %
Change
(as reported)
%
Change
(constant currency)1
Twelve Months Ended December 31, %
Change
(as reported)
%
Change
(constant currency)1
2024 2023 2024 2023
Net product revenues:
Jakafi $ 773,114 $ 695,127 11 % 11 % $ 2,792,107 $ 2,593,732 8 % 8 %
Opzelura 161,602 109,243 48 % 48 % 508,293 337,864 50 % 50 %
Iclusig 27,369 27,130 1 % 1 % 114,319 111,623 2 % 2 %
Pemazyre 23,142 20,653 12 % 12 % 81,748 83,642 (2 %) (2 %)
Minjuvi/ Monjuvi 32,807 8,994 265 % 265 % 119,236 37,057 222 % 222 %
Zynyz 1,373 582 136 % 136 % 3,185 1,250 155 % 155 %
Total net product revenues 1,019,407 861,729 18 % 18 % 3,618,888 3,165,168 14 % 14 %
Royalty revenues:
Jakavi 114,187 103,892 10 % 13 % 418,840 367,583 14 % 16 %
Olumiant 38,485 40,359 (5 %) (3 %) 135,572 136,138 — % 2 %
Tabrecta 6,286 4,678 34 % NA 22,746 17,793 28 % NA
Pemazyre 333 683 NM NM 2,171 1,967 NM NM
Total royalty revenues 159,291 149,612 6 % 579,329 523,481 11 %
Total net product and royalty revenues 1,178,698 1,011,341 17 % 4,198,217 3,688,649 14 %
Milestone and contract revenues — 2,000 — % — % 43,000 7,000 514 % 514 %
Total GAAP revenues $ 1,178,698 $ 1,013,341 16 % $ 4,241,217 $ 3,695,649 15 %
NM = not meaningful
NA = not applicable
1.Percentage change in constant currency is calculated using 2023 foreign exchange rates to recalculate 2024 results.
6
Product and Royalty Revenues Total net product and royalty revenues for the quarter and year ended December 31, 2024 increased 17% and 14%, respectively, over the prior year comparative periods, primarily driven by the following:
•For the quarter ended December 31, 2024, Jakafi net product revenue increased 11% primarily driven by a 14% increase in paid demand. Channel inventory at the end of the fourth quarter of 2024 was within the normal range. For the year ended December 31, 2024, Jakafi net product revenue increased 8% primarily driven by a 9% increase in paid demand.
•For the quarter and year ended December 31, 2024, Opzelura net product revenue increased 48% and 50%, respectively, driven by continued growth in new patient starts and refills in the U.S. and increased contribution from Europe. Opzelura net product revenues included $24 million and $61 million ex-U.S. revenue for the fourth quarter and full year, respectively.
•For the quarter and year ended December 31, 2024, Minjuvi/Monjuvi net product revenue increased 265% and 222%, respectively, as we recognize all revenue from sales of Monjuvi in the United States following the acquisition of exclusive global rights for tafasitamab in February 2024.
•For the quarter and full year ended December 31, 2024, total royalty revenues increased by 6% and 11%, respectively, primarily driven by growth in Jakavi royalty revenues.
Operating Expenses
Operating Expense Summary
(unaudited, in thousands)
Three Months Ended December 31, %
Change Twelve Months Ended December 31, %
Change
2024 2023 2024 2023
GAAP cost of product revenues $ 88,485 $ 69,751 27 % $ 312,068 $ 254,990 22 %
Non-GAAP cost of product revenues1
82,427 63,575 30 % 288,266 230,308 25 %
GAAP research and development 466,034 444,494 5 % 2,606,848 1,627,594 60 %
Non-GAAP research and development2
420,297 408,488 3 % 2,423,167 1,500,897 61 %
GAAP selling, general and administrative 326,710 293,865 11 % 1,242,157 1,161,293 7 %
Non-GAAP selling, general and administrative3
299,709 270,673 11 % 1,116,926 1,069,616 4 %
GAAP (gain) loss on change in fair value of acquisition-related contingent consideration (4,044) 15,058 (127 %) 19,803 29,202 (32 %)
Non-GAAP (gain) loss on change in fair value of acquisition-related contingent consideration — — — % — — — %
GAAP (profit) and loss sharing under collaboration agreements — 2,903 — % (1,025) 2,045 (150 %)
1 Non-GAAP cost of product revenues 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, MorphoSys transition costs, and Escient acquisition related compensation expense related to cash settled unvested Escient equity awards and severance payments.
3 Non-GAAP selling, general and administrative expenses exclude the cost of stock-based compensation, MorphoSys transition costs, Escient acquisition related compensation expense related to cash settled unvested Escient equity awards and severance payments, and asset impairments.
Cost of product revenues GAAP and Non-GAAP cost of product revenues for the quarter and year ended December 31, 2024 increased 27% and 30%, and 22% and 25%, respectively, compared to the same periods in 2023 primarily due to growth in net product revenues, increased royalty expense and increased manufacturing related costs.
Research and development expenses GAAP and Non-GAAP research and development expense for the quarter ended December 31, 2024 increased 5% and 3%, respectively, compared to the same period in 2023, primarily driven by continued investment in our late-stage development assets and timing of certain expenses. GAAP and Non-GAAP research and development expense for the year ended December 31, 2024 increased 60% and 61%, respectively, compared to the same period in 2023, primarily due to the Escient acquisition upfront consideration and related compensation expense and severance payments, and other milestone payments. For the year ended December 31, 2024, excluding the Escient acquisition upfront payment, related compensation expense and severance payments and other milestone payments, research and development expense increased 14% compared to the same period in 2023 as a result of continued investment in our late-stage development assets and timing of certain expenses.
Selling, general and administrative expenses GAAP and Non-GAAP selling, general and administrative expenses for the quarter ended December 31, 2024 increased 11% compared to the same period in 2023, primarily due to the timing of consumer marketing activities and of certain other expenses. GAAP and Non-GAAP selling, general and administrative expenses for the year ended December 31, 2024 increased 7% and 4%, respectively, compared to the same period in 2023, primarily due to $22.1 million of Escient acquisition related compensation expense including severance payments, and timing of consumer marketing activities and of certain other expenses. Excluding the Escient acquisition related compensation expense and severance payments, selling, general and administrative expenses for the year ended December 31, 2024 increased 5% compared to the prior year.
Other Financial Information
Change in fair value of acquisition-related contingent consideration The change in fair value of contingent consideration during the quarter and year ended December 31, 2024, compared to the same periods in 2023, was primarily due to fluctuations in foreign currency exchange rates impacting future revenue projections of Iclusig.
Operating income GAAP and Non-GAAP operating income for the quarter ended December 31, 2024 increased 61% and 41%, respectively, compared to the same period in 2023, primarily driven by growth in total revenues and stable operating expenses. GAAP and Non-GAAP operating income for the year ended December 31, 2024 decreased 90% and 54%, respectively, compared to the same period in 2023, primarily driven by the $679.4 million of expense relating to the IPR&D assets acquired in the Escient acquisition, $38.0 million of Escient acquisition related compensation expense and severance payments, and the $100.0 million milestone payment made to MacroGenics. Excluding upfront and milestone payments and the Escient acquisition related compensation expense and severance payments, operating income for the year ended December 31, 2024 increased 34% compared to the prior year primarily driven by growth in net product revenue.
Cash, cash equivalents and marketable securities position As of December 31, 2024 and 2023, cash, cash equivalents and marketable securities totaled $2.2 billion and $3.7 billion, respectively. The decrease in cash, cash equivalents and marketable securities during 2024 was driven primarily by the $2.0 billion share repurchase completed in June 2024, and the total cash consideration paid to Escient shareholders of $783 million, partially offset by proceeds of sales of equity investments and operating cash flows during the year ended December 31, 2024.
2025 Financial Guidance
Incyte’s guidance for the fiscal year 2025 is summarized below. Guidance for Opzelura includes net product revenue for pediatric atopic dermatitis which has an anticipated approval in the second half of 2025. Guidance for other oncology net product revenues include net product revenue for Monjuvi in follicular lymphoma and Zynyz in squamous cell anal carcinoma. Approvals for these indications are anticipated in the second half of 2025.
Current
Jakafi net product revenues $2,925 – $2,975 million
Opzelura net product revenues $630 – $670 million
Other oncology net product revenues(1)
$415 – $455 million
GAAP Cost of product revenues 8.5% – 9.0% of net product revenues
Non-GAAP Cost of product revenues(2)
7.5% – 8.0% of net product revenues
GAAP Research and development expenses $1,930 – $1,960 million
Non-GAAP Research and development expenses(3)
$1,780 – $1,805 million
GAAP Selling, general and administrative expenses $1,280 – $1,310 million
Non-GAAP Selling, general and administrative expenses(3)
$1,160 – $1,185 million
1Pemazyre in the U.S., EU and Japan; Niktimvo, Monjuvi and Zynyz in the U.S.; and Iclusig and Minjuvi in the EU.
2Adjusted to exclude the amortization of licensed intellectual property for Iclusig relating to the acquisition of the European business of ARIAD Pharmaceuticals, Inc. and the estimated cost of stock-based compensation.
3 Adjusted to exclude the estimated cost of stock-based compensation.
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, 13751174.
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 United States is 877-660-6853 and the dial-in number for international callers is 201-612-7415. To access the replay you will need the conference identification number, 13751174.
The conference call will also be webcast live and can be accessed at investor.incyte.com.