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EX-99.1 2 incy-q32024xexx991.htm EX-99.1 Document

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因塞特報告2024年第三季度財務業績並提供更新

關於重要臨床計劃

–第三季度（Q3'24）營收總額達113800萬美元（年增24%）

–Jakafi® (瑞士利替尼) 第三季度產品銷售額為74100萬美元 (+16% 週年增長); 將2024年Jakafi指引調高至新的區間$2,740 - $277000萬

–Opzelura® (ruxolitinib) 乳膏第三季度產品淨收入達13900萬美元（同比增長 52%）；在美國推出的勢頭持續增長，並受歐洲支付擴展的支持

–尼克蒂姆沃™ (axatilimab-csfr) 獲 FDA 批准用於治療成人和小兒患者至少兩條先前系統治療失敗後的慢性移植與主體疾病

–就盤尼西泮乳膏於小兒過敏性皮膚炎的輔助新藥申請（sNDA）的監管和發展進展已提交，並為CDK2抑制劑、Retifanlimab和Tafasitamab呈現了積極的數據

今日東部時間上午8:00舉行電話會議和網絡直播。

2024年10月29日，特拉華州威明頓。因塞特（納斯達克:INCY）今天報告2024年第三季度財務業績，並提供公司臨床開發組合的最新進展。

2024年第三季度，因塞特取得了顯著成就，包括Jakafi和Opzelura（爾米替尼複方軟膏）的強勁營業收入增長，以及我們臨床管道的推進，其中最值得一提的是向FDA提交爾米替尼複方軟膏在兒童特態性皮膚炎的補充新藥申請（sNDA），以及幾個重要數據揭示，包括CDK2i、retifanlimab、tafasitamab、povorcitinib和爾米替尼複方軟膏，這些板塊都具有接近至中期的上市潛力。此外，今年8月，FDA批准了Niktimvo（axatilimab-csfr）用於兩種前線治療失敗後慢性移植物抗宿主病患者，使其成為第一個獲批用於治療慢性GVHD相關炎症和纖維化的抗CSF-1R抗體。因塞特首席執行官赫爾維·奧珀諾說：「截至2030年，我們將實現超過10個具有重大影響力的上市板塊。」® 2024年第三季度，因塞特取得了顯著成就，包括Jakafi和Opzelura（爾米替尼複方軟膏）的強勁營業收入增長，以及我們臨床管道的推進，其中最值得一提的是向FDA提交爾米替尼複方軟膏在兒童特態性皮膚炎的補充新藥申請（sNDA），以及幾個重要數據揭示，包括CDK2i、retifanlimab、tafasitamab、povorcitinib和爾米替尼複方軟膏，這些板塊都具有接近至中期的上市潛力。此外，今年8月，FDA批准了Niktimvo（axatilimab-csfr）用於兩種前線治療失敗後慢性移植物抗宿主病患者，使其成為第一個獲批用於治療慢性GVHD相關炎症和纖維化的抗CSF-1R抗體。因塞特首席執行官赫爾維·奧珀諾說：「截至2030年，我們將實現超過10個具有重大影響力的上市板塊。」® 2024年第三季度，因塞特取得了顯著成就，包括Jakafi和Opzelura（爾米替尼複方軟膏）的強勁營業收入增長，以及我們臨床管道的推進，其中最值得一提的是向FDA提交爾米替尼複方軟膏在兒童特態性皮膚炎的補充新藥申請（sNDA），以及幾個重要數據揭示，包括CDK2i、retifanlimab、tafasitamab、povorcitinib和爾米替尼複方軟膏，這些板塊都具有接近至中期的上市潛力。此外，今年8月，FDA批准了Niktimvo（axatilimab-csfr）用於兩種前線治療失敗後慢性移植物抗宿主病患者，使其成為第一個獲批用於治療慢性GVHD相關炎症和纖維化的抗CSF-1R抗體。因塞特首席執行官赫爾維·奧珀諾說：「截至2030年，我們將實現超過10個具有重大影響力的上市板塊。」在全球參與者中，阿里巴巴雲作為唯一一家亞洲總部的雲服務提供商被提及。 2024年第三季度，因塞特取得了顯著成就，包括Jakafi和Opzelura（爾米替尼複方軟膏）的強勁營業收入增長，以及我們臨床管道的推進，其中最值得一提的是向FDA提交爾米替尼複方軟膏在兒童特態性皮膚炎的補充新藥申請（sNDA），以及幾個重要數據揭示，包括CDK2i、retifanlimab、tafasitamab、povorcitinib和爾米替尼複方軟膏，這些板塊都具有接近至中期的上市潛力。此外，今年8月，FDA批准了Niktimvo（axatilimab-csfr）用於兩種前線治療失敗後慢性移植物抗宿主病患者，使其成為第一個獲批用於治療慢性GVHD相關炎症和纖維化的抗CSF-1R抗體。因塞特首席執行官赫爾維·奧珀諾說：「截至2030年，我們將實現超過10個具有重大影響力的上市板塊。」

最近公司更新重點

•十月，盼達瑞替尼乳膏用於小兒異位性皮膚炎的sNDA提交已向FDA提出，預計將在2025年下半年獲批。

•十月，Opzelura獲得了Health Canada頒發的一項合規通知，用於治療12歲及以上患者的輕度至中度特應性皮膚炎和非節段性白癜風。

•因塞特於九月在2024年歐洲醫療腫瘤學會議（ESMO）上，公佈了retifanlimab（Zynyz）的突破性第3期結果。®並首次公佈了CDK2抑制劑計畫第1期的初始數據。

◦在總統研討會上推出，第3期POD1Um-303/InterAACT2試驗顯示retifanlimab在鱗狀細胞肛癌（SCAC）患者中符合進展性無瘤存活（PFS）的主要終點，並在接受鉑金基化療法（卡鉑-紫松醇）的患者的次要終點上有改善。因塞特計畫在2024年底前為SCAC中的retifanlimab提交生物製品補充許可申請（sBLA）。2025年的潛在批准可能代表SCAC患者的第一個PD-(L)1抗體。

◦因塞特123667的1期數據顯示，這是一種高度選擇性且可望成為首選CDK2抑制劑，表現出單一藥劑在各種劑量和療程中的抗腫瘤活性，特別是對於那些表達過度Cyclin E1的卵巢癌和子宮內膜癌患者。INCB123667與其他藥劑的聯合1期試驗仍在進行中。因塞特計劃在2025年開展一項在卵巢癌患者中的重要試驗。

•今年八月，因塞特及其合作夥伴Syndax宣佈美國食品藥物管理局（FDA）批准Niktimvo™ （axatilimab-csfr），一種抗CSF-1R抗體，用於治療成人和兒童中至少有兩種先前系統治療失敗的慢性移植物抗宿主病（GVHD）。 Niktimvo是首個獲批准針對慢性GVHD中看到的發炎和纖維化驅動因子的抗CSF-1R抗體。九月，因塞特和Syndax宣布《新英格蘭醫學雜誌》公開了Niktimvo在慢性GVHD中的關鍵性AGAVE-201試驗數據，並將Niktimvo添加到NCCN腫瘤臨床實踐指南，用於治療慢性GVHD。

•因塞特於八月宣布，從第三期臨床試驗評估他法西單抗（Monjuvi）中獲得積極的頂部線結果。®在復發或難治性濾泡性淋巴瘤（FL）中，關鍵的第三期inMIND試驗按照調查員評估在FL中達到了PFS的主要終點。這項試驗也達到了關鍵的次要終點。觀察到了有關他法西單抗的任何新的安全信号。完整數據集預計將在2024年即將舉行的醫學會議上發表，因塞特預計將在2024年底前提交他法西單抗與來那度胺和利妥昔單抗聯合治療FL的sBLA申請。

Jakafi：

2024年第三季度的淨產品收入為74100萬美元（+16% Y/Y）：

▪淨產品收入主要由患者需求推動，在2024年第三季度與前一年同期相比增長10％，所有指標均實現增長。

Opzelura:

2024年第三季度净产品收入為13900萬美元（+52％同比增長）：

▪2024年第三季在美國的凈產品收入為11900萬美元，主要受患者需求和在過敏性皮膚炎（AD）和白癜風（vitiligo）的續方推動。

▪2024年第三季度在美国以外的净产品收入为2000萬美元，主要来自德国和法国的销售。

更新的額外專案資訊

骨髓增生性腫瘤（MPNs）和移植物抗宿主病（GVHD）- 關鍵亮點

▪盧索利替尼延長釋放（XR）的生物等效性研究正在招募中。預計數據將在2025年上半年公佈。

▪一項第二期試驗正在招募新診斷慢性GVHD患者，評估axatilimab與ruxolitinib結合治療的安全性和有效性。

▪盧索利替尼每日兩次（買盤）與BETi和西魏替肽的試驗正在進行中。預計BETi和西魏替肽的額外數據將於2024年第四季公佈。

▪對mCALR和JAK2V617F進行的第一期研究正在進行中，並正在招募患者。兩項研究的初始數據預計在2025年公佈。


MPN和GVHD計畫						適應症和狀態
瑞索利替尼XR（QD）（JAK1/JAK2）						骨髓纖維化、紅血球增多症和GVHD
瑞索利替尼 + zilurgisertib （JAK1/JAK2 + ALK2i）						骨髓纖維化：2期
盧索利替尼 + INCB57643 (JAK1/JAK2 + BETi)						骨髓纖維化：第2階段
盧索利替尼 + axatilimab1 (JAK1/JAK2 + 抗-CSF-1R)						慢性GVHD：第2階段
類固醇 + axatilimab1 (類固醇 + 抗-CSF-1R)						慢性GVHD：第三期準備中
INCA33989 (mCALR)						骨髓纖維化，原發性血小板增多症：第一期
INCB160058 (JAK2V617Fi)						骨髓纖維化：第一期

1 在GVHD中進行的axatilimab臨床研究是與syndax pharmaceuticals合作進行的。

Other Hematology/Oncology – key highlights

▪Following the announcement of the positive topline results from the Phase 3 study evaluating retifanlimab, a humanized monoclonal antibody targeting programmed cell death receptor-1 (PD-1), in non-small cell lung cancer (NSCLC), Incyte anticipates sharing the full dataset at an upcoming medical meeting in the fourth quarter of 2024.

▪The Phase 3 study evaluating tafasitamab in first-line diffuse large B-cell lymphoma (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 are ongoing and enrolling patients. Initial data for both studies are anticipated in 2025.


Heme/Oncology Programs						Indication and status
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 Amplification/ Overexpression of CCNE1: 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

▪In September 2024, Incyte presented multiple datasets for ruxolitinib cream at the 2024 European Academy of Dermatology and Venereology (EADV) Congress including late-breaking oral presentations for vitiligo, atopic dermatitis, hidradenitis suppurativa (HS) and lichen planus.

▪Two Phase 3 trials (TRuE-PN1 and TRuE-PN2) evaluating ruxolitinib cream in prurigo nodularis (PN) are ongoing. The Phase 3 data are anticipated in the first half of 2025.

▪The Phase 3 trial for ruxolitinib cream in mild to moderate HS is on track to initiate in the first half of 2025 following achieving alignment on the study design with FDA. Ruxolitinib cream has the potential to provide a new therapeutic option for the approximately 150,000 mild to moderate HS patients in the U.S.

Povorcitinib (INCB54707)

▪In September 2024, Incyte presented long-term extension data at the 2024 EADV Congress from the Phase 2 randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of povorcitinib in patients with PN. In October 2024, two Phase 3 studies (STOP-PN1 and STOP-PN2) evaluating povorcitinib versus placebo were initiated and are enrolling.

▪The Phase 3 studies of povorcitinib in patients with hidradenitis suppurativa (STOP-HS1 and STOP-HS2) are enrolling well with data anticipated in the first quarter 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.

INCB000262 (MRGPRX2)

▪Three clinical studies evaluating INCB000262 in CSU (Phase 2), chronic inducible urticaria (CIndu) (Phase 1b) and atopic dermatitis (AD) (Phase 2a) are ongoing. Data for all three studies are anticipated in the first quarter of 2025.

INCB000547 (MRGPRX4)

•The phase 2 clinical study evaluating MRGPRX4 in cholestatic pruritus is ongoing with data expected in the first quarter of 2025.


IAI and Dermatology Programs						Indication and status
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) Asthma: Phase 2 Chronic spontaneous urticaria: Phase 2
INCB000262 (MRGPRX2)						Chronic spontaneous urticaria: Phase 2 Chronic inducible urticaria: Phase 1b Atopic dermatitis: Phase 2a
INCB000547 (MRGPRX4)						Cholestatic pruritus: Phase 2a
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 Third Quarter Financial Results

The financial measures presented in this press release for the three and nine months ended September 30, 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

(unaudited, in thousands, except per share amounts)


	Three Months Ended September 30,				Nine Months Ended September 30,
	2024		2023		2024		2023
Total GAAP revenues	$	1,137,871	$	919,025	$	3,062,519	$	2,682,308

Total GAAP operating income (loss)	146,085		214,705		(240,147)		433,255
Total Non-GAAP operating income	255,236		273,294		37,618		625,081

GAAP net income (loss)	106,456		171,269		(168,597)		396,520
Non-GAAP net income (loss)	209,651		248,719		(53,762)		556,325

GAAP basic EPS	$	0.55	$	0.76	$	(0.80)	$	1.77
Non-GAAP basic EPS	$	1.09	$	1.11	$	(0.25)	$	2.49
GAAP diluted EPS1	$	0.54	$	0.76	$	(0.80)	$	1.76
Non-GAAP diluted EPS1	$	1.07	$	1.10	$	(0.25)	$	2.46

1 All stock options and stock awards were excluded from the diluted share calculation for the nine months ended September 30, 2024 because their effect would have been anti-dilutive, as we were in a net loss position.

Revenue Details

(unaudited, in thousands)


	Three Months Ended September 30,				% Change (as reported)		% Change (constant currency)1		Nine Months Ended September 30,				% Change (as reported)		% Change (constant currency)1
	2024		2023						2024		2023
Net product revenues:
Jakafi	$	741,181	$	636,252	16	%	16	%	$	2,018,993	$	1,898,605	6	%	6	%
Opzelura	139,272		91,836		52	%	51	%	346,691		228,621		52	%	52	%
Iclusig	29,745		27,721		7	%	6	%	86,950		84,493		3	%	2	%
Pemazyre	20,661		18,942		9	%	9	%	58,606		62,989		(7	%)	(7	%)
Minjuvi/ Monjuvi	31,439		8,348		277	%	276	%	86,429		28,063		208	%	208	%
Zynyz	694		98		608	%	608	%	1,812		668		171	%	171	%
Total net product revenues	962,992		783,197		23	%	23	%	2,599,481		2,303,439		13	%	13	%
Royalty revenues:
Jakavi	115,741		96,551		20	%	20	%	304,653		263,691		16	%	16	%
Olumiant	34,796		29,615		17	%	22	%	97,087		95,779		1	%	5	%
Tabrecta	5,928		4,139		43	%	NA		16,460		13,115		26	%	NA
Pemazyre	414		523		(21	%)	NM		1,838		1,284		43	%	NM
Total royalty revenues	156,879		130,828		20	%			420,038		373,869		12	%
Total net product and royalty revenues	1,119,871		914,025		23	%			3,019,519		2,677,308		13	%
Milestone and contract revenues	18,000		5,000		260	%	260	%	43,000		5,000		760	%	760	%
Total GAAP revenues	$	1,137,871	$	919,025	24	%			$	3,062,519	$	2,682,308	14	%

NM = not meaningful

NA = not applicable

1 Percentage change in constant currency is calculated using 2023 foreign exchange rates to recalculate 2024 results.

Product and Royalty Revenues Total net product and royalty revenues for the quarter and nine months ended September 30, 2024 increased 23% and 13%, respectively, over the prior year comparative periods, primarily driven by the following:

•For the quarter ended September 30, 2024, Jakafi net product revenue increased 16% primarily driven by a 10% increase in total demand. Channel inventory at the end of the third quarter of 2024 was within the normal range. For the nine months ended September 30, 2024, Jakafi net product revenue increased 6% primarily driven by a 7% increase in total demand.

•For the quarter and nine months ended September 30, 2024, Opzelura net product revenue increased 52% due to continued growth in new patient starts and refills in the U.S. and increased contribution from Europe, driven by continued uptake in Germany and the launch in France.

•For the quarter and nine months ended September 30, 2024, Minjuvi/Monjuvi net product revenue increased 277% and 208%, respectively, following the acquisition of the exclusive global rights to tafasitamab in February 2024.

•For the quarter ended September 30, 2024, total royalty revenues grew by 20%, driven by 20% and 17% growth in Jakavi and Olumiant royalty revenues, respectively. For the nine months ended September 30, 2024, total royalty revenues grew by 12%, driven primarily by 16% growth in Jakavi royalty revenues.

Operating Expenses

Operating Expense Summary

(unaudited, in thousands)


	Three Months Ended September 30,				% Change		Nine Months Ended September 30,				% Change
	2024		2023				2024		2023
GAAP cost of product revenues	$	85,993	$	60,091	43	%	$	223,583	$	185,239	21	%
Non-GAAP cost of product revenues1	79,981		53,914		48	%	205,839		166,733		23	%

GAAP research and development	573,174		375,709		53	%	2,140,814		1,183,100		81	%
Non-GAAP research and development2	525,343		348,868		51	%	2,002,870		1,092,409		83	%

GAAP selling, general and administrative	309,209		267,893		15	%	915,447		867,428		6	%
Non-GAAP selling, general and administrative3	277,311		241,896		15	%	817,217		798,943		2	%

GAAP loss (gain) on change in fair value of acquisition-related contingent consideration	23,410		(426)		(5595	%)	23,847		14,144		69	%
Non-GAAP loss (gain) on change in fair value of acquisition-related contingent consideration4	—		—		—	%	—		—		—	%

GAAP loss and (profit) sharing under collaboration agreements	—		1,053		—	%	(1,025)		(858)		19	%

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.

4 Non-GAAP (gain) loss on change in fair value of acquisition-related contingent consideration is null.

Cost of product revenues GAAP and Non-GAAP cost of product revenues for the quarter and nine months ended September 30, 2024 increased 43% and 48%, and 21% and 23%, 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 September 30, 2024 increased 53% and 51%, respectively, compared to the same period in 2023 primarily due to the $100.0 million milestone payment made to MacroGenics during the third quarter of 2024 and continued investment in our late stage development assets. Excluding upfront and milestone payments and Escient severance payments, research and development expense for the quarter ended September 30, 2024 increased 26% compared to the same period in 2023 due to continued investment in our late stage development assets, additional expenses resulting from the Escient acquisition, and timing of certain expenses. For the nine months ended September 30, 2024, excluding upfront and milestone payments and the Escient acquisition related compensation expense and severance payments, research and development expense increased 15% compared to the same period in 2023 due to continued investment in our late stage development assets, additional expenses resulting from the Escient acquisition, and timing of certain expenses.

Selling, general and administrative expenses GAAP and Non-GAAP selling, general and administrative expenses for the quarter ended September 30, 2024 increased 15% compared to the same period in 2023 primarily due to timing of consumer marketing activities and of certain other expenses.

GAAP and Non-GAAP selling, general and administrative expenses for the nine months ended September 30, 2024 increased 6% and 2%, respectively, compared to the same period in 2023 primarily due to $22.0 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 nine months ended September 30, 2024 increased 3% compared to the same period in 2023.

Other Financial Information

Change in fair value of acquisition-related contingent consideration The change in fair value of contingent consideration during the quarter ended September 30, 2024, compared to the same period 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 three months ended September 30, 2024 decreased 32% and 7%, respectively, compared to the same period in 2023, driven primarily by the $100.0 million milestone payment made to MacroGenics during the third quarter of 2024. Excluding upfront and milestone payments and Escient severance payments, operating income for the three months ended September 30, 2024 increased 14% compared to the same period in 2023 primarily driven by growth in net product revenue.

GAAP and Non-GAAP operating income for the nine months ended September 30, 2024 decreased 155% and 94%, respectively, compared to the same period in 2023, driven primarily by the $679.4 million of expense relating to the IPR&D assets acquired in the Escient acquisition, $36.3 million of Escient acquisition related compensation expense and severance payments, and the $100.0 million milestone payment made to MacroGenics during the third quarter of 2024. Excluding upfront and milestone payments and the Escient acquisition related compensation expense and severance payments, operating income for the nine months ended September 30, 2024 increased 29% compared to the same period in 2023 primarily driven by growth in net product revenue.

Cash, cash equivalents and marketable securities position As of September 30, 2024 and December 31, 2023, cash, cash equivalents and marketable securities totaled $1.8 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 during June 2024, and the total cash consideration paid to Escient shareholders of $783 million, partially offset by proceeds of sales of equity investments during the nine months ended September 30, 2024.

2024 Financial Guidance

Incyte is raising its full year 2024 Jakafi revenue guidance, as well as updating its full year 2024 Other Hematology/Oncology revenue guidance. In addition, Incyte is updating the full year research and development guidance to include the $100 million milestone payment to MacroGenics. The full year GAAP and Non-GAAP research and development guidance now includes $791 million in one-time expenses related to the $691 million of upfront consideration recorded for the acquisition of Escient Pharmaceuticals and the $100 million milestone payment to MacroGenics. Incyte is also maintaining its full year 2024 cost of product revenue and selling general and administrative guidance. Incyte’s guidance is summarized below. The guidance does not include revenue from any potential new product launches or the impact of one-time items and any potential future strategic transactions.


	Current	Previous
Jakafi net product revenues	$2,740 - $2,770 million	$2,710 - $2,750 million
Other Hematology/Oncology net product revenues(1)	$310 - $320 million	$325 - $360 million
GAAP Cost of product revenues	Unchanged	7 – 8% of net product revenues
Non-GAAP Cost of product revenues(2)	Unchanged	6 – 7% of net product revenues
GAAP Research and development expenses	$2,545 - $2,590 million	$2,445 - $2,490 million
Non-GAAP Research and development expenses(3)	$2,395 - $2,435 million	$2,295 - $2,335 million
GAAP Selling, general and administrative expenses	Unchanged	$1,210 - $1,240 million
Non-GAAP Selling, general and administrative expenses(3)	Unchanged	$1,115 - $1,140 million

1Pemazyre in the U.S., EU and Japan; 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.

3Adjusted to exclude the estimated cost of stock-based compensation and Escient acquisition related 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, 13749146.

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, 13749146.

The conference call will also be webcast live and can be accessed at investor.incyte.com.

About Incyte

A global biopharmaceutical company on a mission to Solve On., Incyte follows the science to find solutions for patients with unmet medical needs. Through the discovery, development and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Oncology and Inflammation & Autoimmunity. Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe and Asia.

For additional information on Incyte, please visit Incyte.com or follow us on social media: LinkedIn, X, Instagram, Facebook, YouTube.

About Jakafi® (ruxolitinib)

Jakafi® (ruxolitinib) is a JAK1/JAK2 inhibitor approved by the U.S. FDA for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea; intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF in adults; steroid-refractory acute GVHD in adult and pediatric patients 12 years and older; and chronic GVHD after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.

Jakafi is a registered trademark of Incyte.

About Opzelura® (ruxolitinib) Cream

Opzelura® (ruxolitinib) Cream, a novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib, approved by the U.S. Food & Drug Administration for the topical treatment of nonsegmental vitiligo in patients 12 years of age and older, is the first and only treatment for repigmentation approved for use in the United States. Opzelura is also approved in the U.S. for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Use of Opzelura in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants, such as azathioprine or cyclosporine, is not recommended.

In Europe, Opzelura (ruxolitinib) cream 15mg/g is approved for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.

Incyte has worldwide rights for the development and commercialization of ruxolitinib cream, marketed in the United States as Opzelura.

Opzelura and the Opzelura logo are registered trademarks of Incyte.

About Monjuvi® (tafasitamab-cxix)

Monjuvi® (tafasitamab-cxix) is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. 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). MorphoSys and Incyte entered into: (a) in January 2020, a collaboration and licensing agreement to develop and commercialize tafasitamab globally; and (b) in February 2024, an agreement whereby Incyte obtained exclusive rights to develop and commercialize tafasitamab globally.

Following accelerated approval by the U.S. Food and Drug Administration in July 2020, Monjuvi® (tafasitamab-cxix) is being commercialized in the United States by Incyte. In Europe, Minjuvi® (tafasitamab) received conditional Marketing Authorization from the European Medicines Agency in August 2021.

XmAb® is a registered trademark of Xencor, Inc.

Monjuvi, Minjuvi, the Minjuvi and Monjuvi logos and the “triangle” design are (registered) trademarks of Incyte.

About Pemazyre® (pemigatinib)

Pemazyre® (pemigatinib) is a kinase inhibitor indicated in the United States for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test*. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Pemazyre is also the first targeted treatment approved for use in the United States for treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement.

In Japan, Pemazyre is approved for the treatment of patients with unresectable biliary tract cancer (BTC) with a fibroblast growth factor receptor 2 (FGFR2) fusion gene, worsening after cancer chemotherapy.

In Europe, Pemazyre is approved for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.

Pemazyre is a potent, selective, oral inhibitor of FGFR isoforms 1, 2 and 3 which, in preclinical studies, has demonstrated selective pharmacologic activity against cancer cells with FGFR alterations.

Pemazyre is marketed by Incyte in the United States, Europe and Japan.

Pemazyre is a trademark of Incyte.

* Pemazyre® (pemigatinib) [Package Insert]. Wilmington, DE: Incyte; 2020.

About Iclusig® (ponatinib) tablets

Iclusig® (ponatinib) targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which has been associated with resistance to other approved TKIs.

In the EU, Iclusig is approved for the treatment of adult patients with chronic phase, accelerated phase or blast phase chronic myeloid leukemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation, or the treatment of adult patients with Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.

Click here to view the Iclusig EU Summary of Medicinal Product Characteristics.

Incyte has an exclusive license from Takeda Pharmaceuticals International AG to commercialize ponatinib in the European Union and 29 other countries, including Switzerland, UK, Norway, Turkey, Israel and Russia. Iclusig is marketed in the U.S. by Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.

About Zynyz® (retifanlimab-dlwr)

Zynyz® (retifanlimab) is an intravenous PD-1 inhibitor indicated in the U.S. for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Zynyz is marketed by Incyte in the U.S. In 2017, Incyte entered into an exclusive collaboration and license agreement with MacroGenics, Inc. for global rights to retifanlimab.

Zynyz is a trademark of Incyte.

Forward-Looking Statements

Except for the historical information set forth herein, the matters set forth in this press release contain predictions, estimates and other forward-looking statements, including any discussion of the following: Incyte’s potential for continued performance and growth; Incyte’s financial guidance for 2024, including its expectations regarding sales of Jakafi; expectations regarding demand for and sales of Opzelura, among other products; expectations regarding reimbursement for Opzelura in Europe; expectations regarding the potential and progress of our pipeline, including expectations for ruxolitinib cream, ruxolitinib extended-release (XR), povorcitinib, INCB000262, INCB000547, axatilimab, mCALR, JAK2V617Fi, retifanlimab, tafasitamab, INCB123667, BETi, zilurgisertib, KRASG12D and our TGFβ program; Incyte’s ability to develop new transformative therapies to treat myeloid disease and cure MPNs; expectations regarding ongoing clinical trials and clinical trials to be initiated; expectations regarding data flow/readouts; expectations regarding regulatory filings, potential regulatory approvals and potential product launches; and expectations regarding 2024 newsflow items.

These forward-looking statements are based on Incyte’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: further research and development and the possibility that results of clinical trials will be negative and/or insufficient 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; determinations made by FDA, EMA, and other regulatory agencies; Incyte’s dependence on its relationships with and changes in the plans of its collaboration partners; the efficacy or safety of Incyte’s products and the products of Incyte’s collaboration partners; the acceptance of Incyte’s products and the products of Incyte’s collaboration partners in the marketplace; market competition; unexpected variations in the supply of and/or demand for Incyte’s products and the products of Incyte’s collaboration partners; the effects of announced or unexpected price regulation or limitations on reimbursement or coverage for Incyte’s products and the products of Incyte’s collaboration partners; sales, marketing, manufacturing and distribution requirements, including Incyte’s and its collaboration partners’ ability to successfully commercialize and build commercial infrastructure for newly approved products and any additional products that become approved; greater than expected expenses, including expenses relating to litigation or strategic activities; variations in foreign currency exchange rates; and other risks detailed in Incyte’s reports filed with the Securities and Exchange Commission, including its quarterly report on form 10-Q for the quarter ended June 30, 2024. Incyte disclaims any intent or obligation to update these forward-looking statements.

# # #

Contacts


Media						Investors
media@incyte.com						ir@incyte.com

INCYTE CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(unaudited, in thousands, except per share amounts)


	Three Months Ended September 30,				Nine Months Ended September 30,
	2024		2023		2024		2023

	GAAP				GAAP
Revenues:
Product revenues, net	$	962,992	$	783,197	$	2,599,481	$	2,303,439
Product royalty revenues	156,879		130,828		420,038		373,869
Milestone and contract revenues	18,000		5,000		43,000		5,000
Total revenues	1,137,871		919,025		3,062,519		2,682,308

Costs, expenses and other:
Cost of product revenues (including definite-lived intangible amortization)	85,993		60,091		223,583		185,239
Research and development	573,174		375,709		2,140,814		1,183,100
Selling, general and administrative	309,209		267,893		915,447		867,428
Loss (gain) on change in fair value of acquisition-related contingent consideration	23,410		(426)		23,847		14,144
Loss and (profit) sharing under collaboration agreements	—		1,053		(1,025)		(858)
Total costs, expenses and other	991,786		704,320		3,302,666		2,249,053

Income (loss) from operations	146,085		214,705		(240,147)		433,255
Interest income and other, net	24,195		46,371		118,708		121,912
Interest expense	(774)		(623)		(1,861)		(1,747)
Realized and unrealized (loss) gain on equity investments	(12,982)		(26,654)		126,206		9,839
Income before provision for income taxes	156,524		233,799		2,906		563,259
Provision for income taxes	50,068		62,530		171,503		166,739
Net income (loss)	$	106,456	$	171,269	$	(168,597)	$	396,520

Net income (loss) per share:
Basic	$	0.55	$	0.76	$	(0.80)	$	1.77
Diluted	$	0.54	$	0.76	$	(0.80)	$	1.76

Shares used in computing net income (loss) per share:
Basic	192,629		224,078		211,763		223,428
Diluted	195,838		226,167		211,763		225,756

INCYTE CORPORATION

CONDENSED CONSOLIDATED BALANCE SHEETS

(unaudited, in thousands)


	September 30, 2024		December 31, 2023
ASSETS
Cash, cash equivalents and marketable securities	$	1,771,344	$	3,656,043
Accounts receivable	758,450		743,557
Property and equipment, net	773,102		751,513
Finance lease right-of-use assets, net	25,072		25,535
Inventory	368,416		269,937
Prepaid expenses and other assets	247,243		236,782
Short and long term equity investments	30,910		187,716
Other intangible assets, net	119,994		123,545
Goodwill	155,593		155,593
Deferred income tax asset	762,310		631,886
Total assets	$	5,012,434	$	6,782,107

LIABILITIES AND STOCKHOLDERS’ EQUITY
Accounts payable, accrued expenses and other liabilities	$	1,602,059	$	1,347,669
Finance lease liabilities	32,155		32,601
Acquisition-related contingent consideration	207,000		212,000
Stockholders’ equity	3,171,220		5,189,837
Total liabilities and stockholders’ equity	$	5,012,434	$	6,782,107

INCYTE CORPORATION

RECONCILIATION OF GAAP NET (LOSS) INCOME TO SELECTED NON-GAAP ADJUSTED INFORMATION

(unaudited, in thousands, except per share amounts)


	Three Months Ended September 30,				Nine Months Ended September 30,
	2024		2023		2024		2023
GAAP Net Income (Loss)	$	106,456	$	171,269	$	(168,597)	$	396,520
Adjustments1:
Non-cash stock compensation from equity awards (R&D)2	45,808		26,841		117,141		90,691
Non-cash stock compensation from equity awards (SG&A)2	31,486		20,366		75,607		62,854
Non-cash stock compensation from equity awards (COGS)2	628		793		1,592		2,354
Non-cash interest3	81		108		333		355
Realized and unrealized gain on equity investments4	12,982		26,654		(126,206)		(9,839)
Amortization of acquired product rights5	5,384		5,384		16,152		16,152
Loss (gain) on change in fair value of contingent consideration6	23,410		(426)		23,847		14,144
Asset impairment7	—		5,631		—		5,631
MorphoSys transition costs8	132		—		7,084		—
Escient acquisition related compensation expense9	2,303		—		36,342		—
Tax effect of Non-GAAP pre-tax adjustments10	(19,019)		(7,901)		(37,057)		(22,537)
Non-GAAP Net Income (Loss)	$	209,651	$	248,719	$	(53,762)	$	556,325

Non-GAAP net income (loss) per share:
Basic	$	1.09	$	1.11	$	(0.25)	$	2.49
Diluted11	$	1.07	$	1.10	$	(0.25)	$	2.46

Shares used in computing Non-GAAP net income (loss) per share:
Basic	192,629		224,078		211,763		223,428
Diluted11	195,838		226,167		211,763		225,756

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 September 30, 2024 are milestones of $18,000 and $43,000, respectively, earned from our collaborative partners, as compared to $5,000 of milestones earned for both the three and nine months ended September 30, 2023. Included within the Research and development expenses line item in the Condensed Consolidated Statements of Operations (in thousands) for the three and nine months ended September 30, 2024 are upfront consideration and milestones of $100,000 and $101,414, respectively, related to our collaborative partners as compared to upfront consideration and milestones of $2,950 and $12,650, respectively, for the three and nine months ended September 30, 2023.

2 As included within the Cost of product revenues (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 Realized and unrealized gain on equity investments line item in the Condensed Consolidated Statements of Operations.

5 As included within the Cost of product revenues (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 Selling, general and administrative expenses 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 $226 and $6,489 for the three and nine months ended September 30, 2024, respectively, and included within the Selling, general and administrative expenses line item in the Condensed Consolidated Statements of Operations (in thousands) is a benefit of $94 and expense of $595 for the three and nine months ended September 30, 2024, respectively. MorphoSys transition costs primarily represent employee related costs to transition research and development and selling, general and administrative activities to us under the former collaboration agreement with MorphoSys.

9 Included within the Research and development line item in the Condensed Consolidated Statements of Operations (in thousands) is $1,797 and $14,314, respectively, for the three and nine months ended September 30, 2024, and included within the Selling, general and administrative expenses line item in the Condensed Consolidated Statements of Operations (in thousands) is $506 and $22,028, respectively, for the three and nine months ended September 30, 2024. Escient acquisition related compensation expense represents non-recurring charges associated with (i) cash settled unvested Escient equity awards in connection with the acquisition, and (ii) severance payments to former Escient employees.

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.

11 All stock options and stock awards were excluded from the diluted share calculation for the nine months ended September 30, 2024 because their effect would have been anti-dilutive, as we were in a Non-GAAP net loss position.