Incyte Reports 2024 Third Quarter Financial Results and Provides Updates on Key Clinical Programs
Incyte (INCY) reported strong Q3 2024 financial results with total revenues of $1,138 million, up 24% year-over-year. Jakafi net product revenues reached $741 million (+16% Y/Y), leading to raised full-year guidance of $2,740-$2,770 million. Opzelura cream revenues grew 52% to $139 million. The FDA approved Niktimvo for chronic graft-versus-host disease. The company filed an sNDA for ruxolitinib cream in pediatric atopic dermatitis and presented positive data for multiple pipeline candidates including CDK2 inhibitor, retifanlimab and tafasitamab.
Incyte (INCY) ha riportato risultati finanziari solidi per il terzo trimestre del 2024, con ricavi totali di $1.138 milioni, in aumento del 24% rispetto all'anno precedente. I ricavi netti di prodotto di Jakafi hanno raggiunto $741 milioni (+16% rispetto all'anno scorso), portando a un aumento delle previsioni di ricavi annuali a $2.740-$2.770 milioni. I ricavi della crema Opzelura sono cresciuti del 52% raggiungendo $139 milioni. La FDA ha approvato Niktimvo per la malattia da trapianto contro l'ospite cronica. L'azienda ha presentato una sNDA per la crema di ruxolitinib per la dermatite atopica pediatrica e ha presentato dati positivi per diversi candidati in pipeline, incluso l'inibitore CDK2, retifanlimab e tafasitamab.
Incyte (INCY) informó resultados financieros sólidos para el tercer trimestre de 2024, con ingresos totales de $1,138 millones, un incremento del 24% en comparación con el año anterior. Los ingresos netos del producto Jakafi alcanzaron los $741 millones (+16% interanual), lo que llevó a elevar la guía de ingresos anuales a $2,740-$2,770 millones. Los ingresos de la crema Opzelura crecieron un 52% hasta $139 millones. La FDA aprobó Niktimvo para la enfermedad injerto contra huésped crónica. La compañía presentó una sNDA para la crema de ruxolitinib en dermatitis atópica pediátrica y presentó datos positivos para varios candidatos en su pipeline, incluyendo un inhibidor de CDK2, retifanlimab y tafasitamab.
인사이트 (INCY)는 2024년도 3분기 재무 결과를 발표했으며, 총 수익은 11억 3,800만 달러로 전년 대비 24% 증가했습니다. Jakafi의 순 제품 수익은 7억 4,100만 달러에 달하며(+16% 전년 대비), 연간 가이던스를 27억 4,000만 달러에서 27억 7,000만 달러로 상향 조정했습니다. Opzelura 크림의 수익은 52% 증가하여 1억 3,900만 달러에 달했습니다. FDA는 만성 이식편대숙주병 치료를 위한 Niktimvo를 승인했습니다. 회사는 소아 아토피 피부염에 대한 룩소리티닙 크림의 sNDA를 제출했으며, CDK2 억제제, 레티판리맙 및 타파시타맙을 포함한 여러 파이프라인 후보에 대한 긍정적인 데이터를 발표했습니다.
Incyte (INCY) a annoncé de solides résultats financiers pour le troisième trimestre 2024, avec des revenus totaux de 1,138 milliard de dollars, en hausse de 24 % par rapport à l'année précédente. Les revenus nets du produit Jakafi ont atteint 741 millions de dollars (+16 % par rapport à l'année précédente), ce qui a conduit à une révision à la hausse des prévisions de revenus annuels à 2,740-2,770 millions de dollars. Les revenus de la crème Opzelura ont augmenté de 52 % pour atteindre 139 millions de dollars. La FDA a approuvé Niktimvo pour la maladie chronique du greffon contre l'hôte. L'entreprise a déposé une sNDA pour la crème de ruxolitinib dans la dermatite atopique pédiatrique et a présenté des données positives pour plusieurs candidats en phase de développement, y compris un inhibiteur de CDK2, le retifanlimab et le tafasitamab.
Incyte (INCY) hat starke Finanzergebnisse für das dritte Quartal 2024 gemeldet, mit Gesamterlösen von 1,138 Millionen USD, was einem Anstieg von 24 % im Vergleich zum Vorjahr entspricht. Die Nettoumsätze des Produkts Jakafi erreichten 741 Millionen USD (+16 % im Jahresvergleich), was zu einer Anhebung der Jahresprognose auf 2,740-2,770 Millionen USD führte. Die Umsätze der Creme Opzelura stiegen um 52 % auf 139 Millionen USD. Die FDA genehmigte Niktimvo zur Behandlung der chronischen Graft-versus-Host-Krankheit. Das Unternehmen reichte einen sNDA für Ruxolitinib-Creme bei pädiatrischer atopischer Dermatitis ein und präsentierte positive Daten für mehrere Kandidaten in der Pipeline, darunter einen CDK2-Hemmer, Retifanlimab und Tafasitamab.
- Total revenues increased 24% Y/Y to $1,138 million in Q3 2024
- Jakafi revenues grew 16% Y/Y to $741 million with 10% patient demand growth
- Opzelura revenues increased 52% Y/Y to $139 million
- FDA approval of Niktimvo for chronic GVHD treatment
- Raised full year 2024 Jakafi guidance to $2,740-$2,770 million
- GAAP operating income decreased to $146 million in Q3 2024 from $215 million in Q3 2023
- GAAP net loss of $169 million for the nine months ended September 2024 compared to net income of $397 million in 2023
- Research and development expenses increased 53% Y/Y
Insights
Strong Q3 2024 results with
Notable pipeline progress includes FDA approval of Niktimvo for chronic GVHD and positive Phase 3 results for retifanlimab in anal cancer. The sNDA filing for ruxolitinib cream in pediatric atopic dermatitis sets up potential approval in H2 2025. However, operating income declined to
Significant clinical development momentum across multiple therapeutic areas. The CDK2 inhibitor showed promising early results in ovarian and endometrial cancers, with pivotal trials planned for 2025. Positive Phase 3 data for tafasitamab in follicular lymphoma and retifanlimab in anal cancer strengthen the oncology portfolio.
The dermatology franchise continues expanding with ruxolitinib cream's potential in new indications like hidradenitis suppurativa and prurigo nodularis. Multiple late-stage trials for povorcitinib in various inflammatory conditions demonstrate a robust immunology pipeline, positioning Incyte for significant growth through 2030.
-
Total revenues of
in the third quarter (Q3'24) (+$1,138 million 24% Y/Y) -
Jakafi® (ruxolitinib) net product revenues of
in Q3'24 (+$741 million 16% Y/Y); raising full year 2024 Jakafi guidance to a new range of -$2,740 $2,770 million -
Opzelura® (ruxolitinib) cream net product revenues of
in Q3'24 (+$139 million 52% Y/Y); launch momentum continues in theU.S. supported by reimbursement expansion inEurope - Niktimvo™ (axatilimab-csfr) approved by FDA for the treatment of chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy in adult and pediatric patients
- Regulatory and development progress with supplemental New Drug Application (sNDA) for ruxolitinib cream in pediatric atopic dermatitis filed and positive data presented for CDK2 inhibitor, retifanlimab and tafasitamab
Conference Call and Webcast Scheduled Today at 8:00 a.m. ET
"In the third quarter of 2024, we delivered significant achievements, including strong revenue growth for both Jakafi® (ruxolitinib) and Opzelura® (ruxolitinib) cream, and the advancement of our clinical pipeline highlighted by the submission to the FDA of the supplemental New Drug Application (sNDA) for ruxolitinib cream in pediatric atopic dermatitis and several key data readouts including CDK2i, retifanlimab, tafasitamab, povorcitinib and ruxolitinib cream, which all hold near to mid-term launch potential. Additionally, in August, the FDA approved Niktimvo™ (axatilimab-csfr) for patients with chronic graft-versus-host disease, after failure of two prior lines of therapy, making it the first anti-CSF-1R antibody approved to target the inflammation and fibrosis associated with chronic GVHD," said Hervé Hoppenot, Chief Executive Officer, Incyte. “We are on track to achieve over ten impactful launches by 2030.”
Key Recent Company Updates
- In October, the sNDA submission for ruxolitinib cream in pediatric atopic dermatitis was filed with the FDA with approval anticipated in the second half of 2025.
- In October, 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.
-
In September, Incyte presented late-breaking Phase 3 results for retifanlimab (Zynyz®) and initial data from the Phase 1 CDK2 inhibitor program at the 2024 European Society for Medical Oncology (ESMO) Congress.
- Featured during the Presidential Symposium, the Phase 3 POD1UM-303/InterAACT2 trial for retifanlimab met the primary endpoint of progression free survival (PFS) and demonstrated improvement across secondary endpoints in patients with squamous cell anal carcinoma (SCAC) receiving retifanlimab in combination with platinum-based chemotherapy (carboplatin-paclitaxel). Incyte plans to file a supplemental Biologics License Application (sBLA) for retifanlimab in SCAC by the end of 2024. A potential approval in 2025 could represent the first PD-(L)1 antibody for patients with SCAC.
- Phase 1 data of INCB123667, a highly selective and potentially first-in-class CDK2 inhibitor, were presented demonstrating single-agent antitumor activity across a range of doses and regimens, notably in patients with ovarian cancer and endometrial cancer whose tumors overexpress Cyclin E1. The Phase 1 trial of INCB123667 in combination with other agents is ongoing. Incyte plans to initiate a pivotal trial in ovarian cancer in 2025.
-
In August, Incyte and its partner Syndax announced the
U.S. Food and Drug Administration (FDA) approval of Niktimvo, an anti-CSF-1R antibody, for the treatment of chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients. Niktimvo is the first approved anti-CSF-1R antibody targeting the drivers of inflammation and fibrosis seen in chronic GVHD. In September, Incyte and Syndax announced the New England Journal of Medicine publication of data from the pivotal AGAVE-201 trial of Niktimvo in chronic GVHD and the addition of Niktimvo to the NCCN Clinical Practice Guidelines in Oncology for the treatment of chronic GVHD. - In August, Incyte announced positive topline results from the Phase 3 clinical study evaluating tafasitamab (Monjuvi®) in relapsed or refractory follicular lymphoma (FL). The pivotal Phase 3 inMIND trial met the primary endpoint of PFS by investigator assessment in FL. The trial also met key secondary endpoints. No new safety signals with tafasitamab were observed. The full dataset is anticipated to be presented at an upcoming medical meeting in 2024 and Incyte expects to file an sBLA for tafasitamab in combination with lenalidomide and rituximab in FL by the end of 2024.
Jakafi:
Net product revenues for the third quarter 2024 of
-
Net product revenues were primarily driven by patient demand, which increased
10% in the third quarter of 2024 versus the same quarter in the prior year, with growth across all indications.
Opzelura:
Net product revenues for the third quarter 2024 of
-
Net product revenues of
in the third quarter of 2024 in the$119 million U.S. were primarily driven by patient demand and refills in both atopic dermatitis (AD) and vitiligo. -
Net product revenues of
in the third quarter of 2024 ex-$20 million U.S. were primarily driven by sales inGermany andFrance .
Additional Pipeline Updates
Myeloproliferative Neoplasms (MPNs) and Graft-Versus-Host Disease (GVHD) – key highlights
- A bioequivalence study of ruxolitinib extended-release (XR) is enrolling. The data are anticipated in the first half of 2025.
- A Phase 2 trial evaluating the safety and efficacy of axatilimab in combination with ruxolitinib in patients with newly diagnosed chronic GVHD is enrolling.
- Trials of ruxolitinib twice daily (BID) with BETi and zilurgisertib are ongoing. Additional data for BETi and zilurgisertib are anticipated in the fourth quarter of 2024.
- The Phase 1 studies evaluating mCALR and JAK2V617Fi are ongoing and enrolling patients. Initial data for both studies are anticipated in 2025.
MPN and GVHD Programs |
|
Indication and status |
Ruxolitinib XR (QD) (JAK1/JAK2) |
|
Myelofibrosis, polycythemia vera and GVHD |
Ruxolitinib + zilurgisertib (JAK1/JAK2 + ALK2i) |
|
Myelofibrosis: Phase 2 |
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 in preparation |
INCA33989 (mCALR) |
|
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
- 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.
|
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 |
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
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
|
|
Nine Months Ended
|
||||||||||||
|
|
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
Revenue Details (unaudited, in thousands) |
|||||||||||||||||||||||||||
|
Three Months Ended
|
|
% Change (as reported) |
|
% Change (constant currency)1 |
|
Nine Months Ended
|
|
% 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
|
Product and Royalty Revenues Total net product and royalty revenues for the quarter and nine months ended September 30, 2024 increased
-
For the quarter ended September 30, 2024, Jakafi net product revenue increased
16% primarily driven by a10% 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 increased6% primarily driven by a7% 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 theU.S. and increased contribution fromEurope , driven by continued uptake inGermany and the launch inFrance . -
For the quarter and nine months ended September 30, 2024, Minjuvi/Monjuvi net product revenue increased
277% and208% , 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 by20% and17% growth in Jakavi and Olumiant royalty revenues, respectively. For the nine months ended September 30, 2024, total royalty revenues grew by12% , driven primarily by16% growth in Jakavi royalty revenues.
Operating Expenses
Operating Expense Summary (unaudited, in thousands) |
|||||||||||||||||||||
|
Three Months Ended
|
|
% Change |
|
Nine Months Ended
|
|
% 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.
|
Cost of product revenues GAAP and Non-GAAP cost of product revenues for the quarter and nine months ended September 30, 2024 increased
Research and development expenses GAAP and Non-GAAP research and development expense for the quarter ended September 30, 2024 increased
Selling, general and administrative expenses GAAP and Non-GAAP selling, general and administrative expenses for the quarter ended September 30, 2024 increased
GAAP and Non-GAAP selling, general and administrative expenses for the nine months ended September 30, 2024 increased
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
GAAP and Non-GAAP operating income for the nine months ended September 30, 2024 decreased
Cash, cash equivalents and marketable securities position As of September 30, 2024 and December 31, 2023, cash, cash equivalents and marketable securities totaled
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
|
Current |
Previous |
Jakafi net product revenues |
|
|
Other Hematology/Oncology net product revenues(1) |
|
|
GAAP Cost of product revenues |
Unchanged |
7 – |
Non-GAAP Cost of product revenues(2) |
Unchanged |
6 – |
GAAP Research and development expenses |
|
|
Non-GAAP Research and development expenses(3) |
|
|
GAAP Selling, general and administrative expenses |
Unchanged |
|
Non-GAAP Selling, general and administrative expenses(3) |
Unchanged |
|
1Pemazyre in the |
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 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
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
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
In
Incyte has worldwide rights for the development and commercialization of ruxolitinib cream, marketed in
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
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
Pemazyre is also the first targeted treatment approved for use in
In
In
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
Pemazyre is a trademark of Incyte.
* Pemazyre® (pemigatinib) [Package Insert]. |
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
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
About Zynyz® (retifanlimab-dlwr)
Zynyz® (retifanlimab-dlwr) is an intravenous PD-1 inhibitor indicated in the
Zynyz is marketed by Incyte in the
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
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.
INCYTE CORPORATION
|
|||||||||||||||
|
Three Months Ended
|
|
Nine Months Ended
|
||||||||||||
|
|
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
|
|||||||
|
September 30,
|
|
December 31,
|
||||
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
|
|
Nine Months Ended
|
||||||||||||
|
|
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 |
View source version on businesswire.com: https://www.businesswire.com/news/home/20241029417349/en/
Media
media@incyte.com
Investors
ir@incyte.com
Source: Incyte
FAQ
What were Incyte's (INCY) total revenues in Q3 2024?
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What is Incyte's (INCY) new full-year 2024 guidance for Jakafi?