INCY Incyte Corporation

78.45
-2.16  -3%
Previous Close 80.61
Open 79.85
52 Week Low 62.48
52 Week High 110.365
Market Cap $17,246,722,340
Shares 219,843,497
Float 186,417,943
Enterprise Value $15,618,187,132
Volume 1,073,368
Av. Daily Volume 1,257,983
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Upcoming Catalysts

Drug Stage Catalyst Date
Jakafi
Myelofibrosis
Approved
Approved
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Ruxolitinib
Atopic dermatitis
PDUFA priority review
PDUFA priority review
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Ruxolitinib
Steroid-refractory chronic GVHD (Graft versus host disease)
PDUFA priority review
PDUFA priority review
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Ruxolitinib - TRuE-V
Vitiligo
Phase 3
Phase 3
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Retifanlimab
Squamous Cell Carcinoma of the Anal Canal (SCAC)
PDUFA priority review
PDUFA priority review
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Baricitinib
Alopecia Areata
Phase 3
Phase 3
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INCB86550
Solid Tumors
Phase 1
Phase 1
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Parsaclisib INCB50465 (CITADEL-203)
Follicular lymphoma
NDA Filing
NDA Filing
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Baricitinib
Systemic lupus erythematosus (SLE)
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
Parsaclisib (CITADEL-204)
Marginal Zone Lymphoma
Phase 2
Phase 2
Phase 2 data presented at ASH December 2020. ORR 57%.
INCB001158
Biliary tract cancers
Phase 1/2
Phase 1/2
Phase 1/2 data presented at ASCO GI January 15-17, 2021.
Ruxolitinib (Jakafi)
COVID-19 associated cytokine storm
Phase 3
Phase 3
Phase 3 top-line did not meet primary endpoint - December 14, 2020.
Pelareorep and retifanlimab (INCMGA00012) - IRENE
Triple-negative breast cancer.
Phase 2
Phase 2
Phase 2 trial ongoing.
Baricitinib and remdesivir
COVID-19
Approved
Approved
Emergency use authorization (EUA) issued by FDA November 19, 2020.
Itacitinib - GRAVITAS-309
Chronic Graft-Versus-Host Disease
Phase 3
Phase 3
Phase 3 trial ongoing.
Ruxolitinib (RESET)
Essential thrombocythemia
Phase 3
Phase 3
Recruitment has been discontinued - February 13, 2020.
Retifanlimab (MGA012/INCMGA00012) - (POD1UM-304)
Non-small cell lung cancer (NSCLC)
Phase 3
Phase 3
Phase 3 trial initiation announced September 21, 2020.
Retifanlimab INCMGA0012
Anal cancer
Phase 2
Phase 2
Phase 2 data noted objective response rate of 14% and disease control rate of 49% - September 18, 2020.
Ruxolitinib - REACH 2
Steroid-refractory acute GVHD (Graft versus host disease)
Phase 3
Phase 3
Phase 3 data met primary endpoint - October 16, 2019.
Tafasitamab (MOR208/XmAb5574)
Relapsed or refractory diffuse large B cell lymphoma
Approved
Approved
FDA Approval announced July 31, 2020.
Capmatinib
Non-small cell lung cancer
Approved
Approved
FDA Approval announced May 6, 2020.
Pemigatinib
Cholangiocarcinoma
Approved
Approved
FDA Approval announced April 17, 2020.
Itacitinib - GRAVITAS-301
Treatment-naïve acute GVHD
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - January 2, 2020.
Pemigatinib (FIGHT-302)
Cholangiocarcinoma - first line
Phase 3
Phase 3
Phase 3 initiation of dosing announced June 4, 2019.
Baricitinib
Atopic dermatitis
Phase 3
Phase 3
Phase 3 BREEZE-AD5 trial met primary endpoint - January 30, 2020.
Epacadostat with pembrolizumab (ECHO-302)
Renal cancer
Phase 3
Phase 3
Phase 3 enrollment to be discontinued.
Ruxolitinib
Graft versus host disease
Approved
Approved
FDA approval announced May 24, 2019.
INCB50465 (CITADEL-202)
Diffuse large B cell lymphoma
Phase 2
Phase 2
Phase 2 trial to be discontinued - noted June 21, 2018.
Baricitinib
Rheumatoid arthritis
Approved
Approved
CRL received April 14, 2017. NDA resubmitted. Approval announced for low dose only - June 1, 2018.
Epacadostat with Keytruda - ECHO-301
Cancer - first-line metastatic melanoma.
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - noted April 6, 2018.
Jakafi (ruxolitinib) (RELIEF)
Disease-related symptoms in patients with Polycythemia Vera
Phase 3
Phase 3
Endpoint not met, mid-2014
Ruxolitinib
Colorectal cancer
Phase 2
Phase 2
Phase 2 trial stopped January 2016 due to lack of efficacy
Ruxolitinib - JANUS 1 and JANUS 2
Cancer - Pancreatic
Phase 3
Phase 3
Phase 3 trial discontinued due to lack of efficacy
Jakafi (ruxolitinib) (RESPONSE)
Polycythemia Vera
Approved
Approved
Approved December 4, 2014.

Latest News

  1. Incyte (NASDAQ:INCY) today announced the validation of the Company's Marketing Authorization Application (MAA) for retifanlimab, an intravenous PD-1 inhibitor, as a potential treatment for adult patients with locally advanced or metastatic squamous cell anal carcinoma (SCAC) who have progressed on, or who are intolerant of, platinum-based chemotherapy. The European Medicines Agency's (EMA) validation of the MAA confirms that the submission is sufficiently complete to begin the formal review process.

    "While the incidence of SCAC is increasing in Europe, treatment options for advanced disease are limited in their effectiveness, and there are no approved options once patients have progressed on standard therapy," said Lance Leopold, M.D., Group…

    Incyte (NASDAQ:INCY) today announced the validation of the Company's Marketing Authorization Application (MAA) for retifanlimab, an intravenous PD-1 inhibitor, as a potential treatment for adult patients with locally advanced or metastatic squamous cell anal carcinoma (SCAC) who have progressed on, or who are intolerant of, platinum-based chemotherapy. The European Medicines Agency's (EMA) validation of the MAA confirms that the submission is sufficiently complete to begin the formal review process.

    "While the incidence of SCAC is increasing in Europe, treatment options for advanced disease are limited in their effectiveness, and there are no approved options once patients have progressed on standard therapy," said Lance Leopold, M.D., Group Vice President, Immuno-Oncology Clinical Development, Incyte. "The EMA validation of the MAA for retifanlimab – which follows the recent U.S. Food & Drug Administration acceptance of our Biologics License Application for Priority Review – brings us closer to providing a new option for patients in Europe with this rarely studied tumor."

    The MAA is based on data from the Phase 2 POD1UM-202 trial evaluating retifanlimab in previously treated patients with locally advanced or metastatic SCAC who have progressed on, or are intolerant of, standard platinum-based chemotherapy which were presented at the 2020 virtual ESMO Congress.

    SCAC is associated with human papillomavirus (HPV) and HIV infections and accounts for almost 3% of digestive system cancers.1 In Europe, each year approximately 12,000 patients receive SCAC diagnosis.2 Patients with metastatic SCAC have a poor 5-year survival and there are no approved treatments for patients who progress on platinum therapy.3

    About POD1UM-202

    POD1UM-202 (NCT03597295) is a global, open-label, single-arm, multicenter, Phase 2 study evaluating retifanlimab in patients with squamous cell anal carcinoma (SCAC) who have progressed on, or who are intolerant of, platinum-based chemotherapy. Retifanlimab 500 mg is administered intravenously every 4 weeks.

    The primary endpoint is objective response rate (ORR) as determined by independent central review using RECIST v1.1. Secondary endpoints include additional measures of clinical benefit ‒ duration of response (DOR), disease control rate (DCR), progression-free survival (PFS) and overall survival (OS); safety and pharmacokinetics.

    For more information about the study, please visit https://clinicaltrials.gov/ct2/show/NCT03597295.

    About POD1UM

    The POD1UM (PD1 Inhibitor Clinical Program in Multiple Malignancies) clinical trial program for retifanlimab includes POD1UM-202, POD1UM-303 in SCAC along with and benchmarking studies in endometrial cancer, Merkel cell carcinoma and other solid tumors. A Phase 3 trial in NSCLC (POD1UM-304) is also enrolling, as are studies in combination with epacadostat, pemigatinib, and other development compounds in the Incyte portfolio.

    About Retifanlimab

    Retifanlimab (formerly INCMGA0012), an investigational intravenous anti-PD1 antibody, is currently under evaluation in registration-directed trials as a monotherapy for patients with microsatellite instability-high endometrial cancer, Merkel cell carcinoma and squamous cell anal carcinoma (SCAC); and in combination with platinum-based chemotherapy for patients with non-small cell lung cancer.

    Retifanlimab has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of anal cancer, and the Biologics License Application for retifanlimab has been accepted for Priority Review.

    In 2017, Incyte entered into an exclusive collaboration and license agreement with MacroGenics, Inc. for global rights to retifanlimab. In 2019, Incyte and Zai Lab announced a collaboration and license agreement for the development and commercialization of retifanlimab in Greater China.

    About Incyte

    Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

    Forward Looking Statements

    Except for the historical information set forth herein, the matters set forth in this press release, including statements about whether or when the EMA may authorize retifanlimab for the treatment of patients with squamous cell anal carcinoma (SCAC), the potential of retifanlimab to provide a meaningful treatment for patients with SCAC, the retifanlimab development program, and the safety and efficacy of retifanlimab in patients with SCAC, contain predictions, estimates and other forward-looking statements.

    These forward-looking statements are based on the Company'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: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by European regulatory authorities or other regulatory authorities, including the U.S. FDA; the Company's dependence on its relationships with its collaboration partners; the efficacy or safety of the Company's products and the products of the Company's collaboration partners; the acceptance of the Company's products and the products of the Company's collaboration partners in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; greater than expected expenses; expenses relating to litigation or strategic activities; and other risks detailed from time to time in the Company's reports filed with the Securities and Exchange Commission, including its Form 10-K for the year ending December 31, 2020. The Company disclaims any intent or obligation to update these forward-looking statements.

    1 Ghosn M, et.al. Anal cancer treatment: current status and future perspectives. World J Gastroenterol 2015;21:2294-2302.

    2 Globocan

    3 Glynne-Jones R, et al. Ann Oncol. 2014;25(suppl 3):iii10–iii20.

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  2. Incyte (NASDAQ:INCY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for ruxolitinib (Jakafi®) for treatment of steroid-refractory chronic graft-versus-host disease (GVHD) in adult and pediatric patients 12 years and older.

    The sNDA submission is based on results from the Phase 3, randomized REACH3 study comparing ruxolitinib with best available therapy (BAT) in patients with steroid-refractory chronic GVHD. In the REACH3 study, which was recently presented at the 62nd American Society of Hematology (ASH) Annual Meeting & Exposition, patients treated with ruxolitinib experienced a significantly greater overall response rate (ORR) compared to BAT…

    Incyte (NASDAQ:INCY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for ruxolitinib (Jakafi®) for treatment of steroid-refractory chronic graft-versus-host disease (GVHD) in adult and pediatric patients 12 years and older.

    The sNDA submission is based on results from the Phase 3, randomized REACH3 study comparing ruxolitinib with best available therapy (BAT) in patients with steroid-refractory chronic GVHD. In the REACH3 study, which was recently presented at the 62nd American Society of Hematology (ASH) Annual Meeting & Exposition, patients treated with ruxolitinib experienced a significantly greater overall response rate (ORR) compared to BAT at Week 24, the primary endpoint (49.7% vs. 25.6%; p<0.0001). For the key secondary endpoints, ruxolitinib was associated with a longer median failure-free survival (FFS) than BAT at Week 24 (not reached vs. 5.7 months; hazard ratio (HR), 0.370; p<0.0001), and greater symptom improvement per the modified Lee Symptom Scale (mLSS) at Week 24 (24.2% vs. 11.0%; odds ratio (OR), 2.62; p=0.0011). The best ORR for patients receiving ruxolitinib was 76.4%. No new safety signals were observed, and adverse events were consistent with the known safety profile of ruxolitinib.

    "Chronic GVHD is a life-threatening complication following stem cell transplant that burdens a vulnerable patient population, which today has limited treatment options," said Peter Langmuir, M.D., Group Vice President, Oncology Targeted Therapies, Incyte. "The acceptance of this sNDA represents an important milestone for Incyte as we continue our work towards helping more people living with GVHD, particularly for those who do not respond to steroids. We look forward to working closely with the FDA to bring this innovative therapy to patients and to providing continued support to the GVHD community in the United States."

    GVHD is a condition that can occur after an allogeneic stem cell transplant (the transfer of stem cells from a donor) in which the donated cells initiate an immune response and attack the transplant recipient's organs, leading to significant morbidity and mortality. There are two major forms of GVHD: acute, which generally occurs within 100 days of transplant, and chronic, which generally occurs after 100 days of transplant1. Both forms can affect multiple organ systems, including the skin, gastrointestinal (digestive) tract and liver.

    The FDA grants Priority Review to medicines that may offer a major advance in treatment where none currently exists. This designation shortens the review period to six months compared to 10 months for Standard Review. The Prescription Drug User Fee Act (PDUFA) target action date for Jakafi in steroid-refractory chronic GVHD is June 22, 2021.

    The sNDA is also being reviewed as part of the Project Orbis program, an initiative of the U.S. FDA Oncology Center of Excellence that provides a framework for concurrent submission and review of oncology drugs among international regulatory agencies. Participating countries for this application include Canada, Australia, Switzerland, Brazil and the United Kingdom.

    In 2019, Jakafi was approved by the U.S. Food and Drug Administration for the treatment of steroid-refractory acute GVHD in adult and pediatric patients 12 years and older2.

    About REACH3

    REACH3 (NCT03112603), a randomized, open-label, multicenter Phase 3 study sponsored by Novartis and conducted in collaboration with and co-funded by Incyte, is evaluating the safety and efficacy of ruxolitinib compared with best available therapy in patients with steroid-refractory chronic GVHD.

    The primary endpoint is overall response rate (ORR) at Week 24 (i.e., Cycle 7, Day 1), defined as the percentage of participants demonstrating a complete or partial response. Key secondary endpoints include failure-free survival (FFS) and change in the modified Lee Symptom Scale (mLSS) score at Week 24. Other secondary endpoints include best overall response (BOR), duration of response (DoR), overall survival (OS), and safety. For more information about the study, please visit https://clinicaltrials.gov/ct2/show/NCT03112603.

    About REACH

    The REACH clinical trial program evaluating ruxolitinib in patients with steroid-refractory GVHD includes the randomized pivotal Phase 3 REACH2 and REACH3 trials, conducted in collaboration with Novartis.

    The REACH program was initiated with the Incyte-sponsored REACH1 trial, a prospective, open-label, single-cohort, multicenter, pivotal Phase 2 trial (NCT02953678) evaluating Jakafi in combination with corticosteroids in patients with steroid-refractory grade II-IV acute GVHD. For more information about the study, including trial results, please visit https://clinicaltrials.gov/show/NCT02953678.

    About Jakafi® (ruxolitinib)

    Jakafi is a first-in-class JAK1/JAK2 inhibitor approved by the U.S. FDA for the 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, and for the treatment of steroid-refractory acute GVHD in adult and pediatric patients 12 years and older.

    Jakafi is marketed by Incyte in the United States and by Novartis as Jakavi® (ruxolitinib) outside the United States. Jakafi is a registered trademark of Incyte Corporation. Jakavi is a registered trademark of Novartis AG in countries outside the United States.

    Important Safety Information

    Jakafi can cause serious side effects, including:

    Low blood counts: Jakafi® (ruxolitinib) may cause your platelet, red blood cell, or white blood cell counts to be lowered. If you develop bleeding, stop taking Jakafi and call your healthcare provider. Your healthcare provider will perform blood tests to check your blood counts before you start Jakafi and regularly during your treatment. Your healthcare provider may change your dose of Jakafi or stop your treatment based on the results of your blood tests. Tell your healthcare provider right away if you develop or have worsening symptoms such as unusual bleeding, bruising, tiredness, shortness of breath, or a fever.

    Infection: You may be at risk for developing a serious infection during treatment with Jakafi. Tell your healthcare provider if you develop any of the following symptoms of infection: chills, nausea, vomiting, aches, weakness, fever, painful skin rash or blisters.

    Skin cancers: Some people who take Jakafi have developed certain types of non-melanoma skin cancers. Tell your healthcare provider if you develop any new or changing skin lesions.

    Increases in cholesterol: You may have changes in your blood cholesterol levels. Your healthcare provider will do blood tests to check your cholesterol levels during your treatment with Jakafi.

    The most common side effects of Jakafi include: for certain types of MF and PV - low platelet or low red blood cell counts, bruising, dizziness, headache, and diarrhea; and for acute GVHD – low platelet, red or white blood cell counts, infections, and fluid retention.

    These are not all the possible side effects of Jakafi. Ask your pharmacist or healthcare provider for more information. Tell your healthcare provider about any side effect that bothers you or that does not go away.

    Before taking Jakafi, tell your healthcare provider about: all the medications, vitamins, and herbal supplements you are taking and all your medical conditions, including if you have an infection, have or had tuberculosis (TB), or have been in close contact with someone who has TB, have or had hepatitis B, have or had liver or kidney problems, are on dialysis, have a high level of fat in your blood (high blood cholesterol or triglycerides), had skin cancer or have any other medical condition. Take Jakafi exactly as your healthcare provider tells you. Do not change or stop taking Jakafi without first talking to your healthcare provider.

    Women should not take Jakafi while pregnant or planning to become pregnant. Do not breast-feed during treatment with Jakafi and for 2 weeks after the final dose.

    Full Prescribing Information, which includes a more complete discussion of the risks associated with Jakafi, is available at www.jakafi.com.

    About Incyte

    Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

    Forward-Looking Statements

    Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the Company's ongoing clinical development program for ruxolitinib, the REACH program and the Company's GVHD program generally, and whether and when ruxolitinib will be approved for use in the U.S. or elsewhere for steroid-refractory chronic GVHD or any other indication, contain predictions, estimates and other forward-looking statements.

    These forward-looking statements are based on the Company'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: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by the FDA; the Company's dependence on its relationships with its collaboration partners; the efficacy or safety of the Company's products and the products of the Company's collaboration partners; the acceptance of the Company's products and the products of the Company's collaboration partners in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; greater than expected expenses; expenses relating to litigation or strategic activities; and other risks detailed from time to time in the Company's reports filed with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2020. The Company disclaims any intent or obligation to update these forward-looking statements.

    1 Ferrara JL., et al. Graft-versus-host disease. Lancet. 2009;373(9674):1550-1561.

    2 Jakafi (ruxolitinib) tablets: Prescribing Information. U.S. Food and Drug Administration; January 2020.

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  3. Incyte (NASDAQ:INCY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for ruxolitinib cream, a selective JAK1/JAK2 inhibitor designed for topical application, as a treatment for atopic dermatitis (AD), a type of eczema.

    "Incyte's deep understanding of the pathways involved in immune-mediated skin conditions led us to investigate the potential for ruxolitinib cream to address key factors associated with atopic dermatitis, that is, inflammation of the skin and itch," said Jim Lee, M.D., Ph.D., Group Vice President, Inflammation & Autoimmunity, Incyte. "We are grateful to the people living with atopic dermatitis whose participation in our clinical trials helped generate…

    Incyte (NASDAQ:INCY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for ruxolitinib cream, a selective JAK1/JAK2 inhibitor designed for topical application, as a treatment for atopic dermatitis (AD), a type of eczema.

    "Incyte's deep understanding of the pathways involved in immune-mediated skin conditions led us to investigate the potential for ruxolitinib cream to address key factors associated with atopic dermatitis, that is, inflammation of the skin and itch," said Jim Lee, M.D., Ph.D., Group Vice President, Inflammation & Autoimmunity, Incyte. "We are grateful to the people living with atopic dermatitis whose participation in our clinical trials helped generate the evidence to support this regulatory submission, and we look forward to working with the FDA as we seek to bring forward a new topical treatment for people living with this chronic skin disease."

    The NDA is supported by data from the Phase 3 TRuE-AD clinical trial program, which included more than 1,200 people, age 12 years and older. Primary efficacy and safety results from both TRuE-AD trials were presented at the Revolutionizing Atopic Dermatitis Virtual Symposium in April 2020. Additional safety and efficacy data from the 44-week, open-label, long-term extension of both TRuE-AD1 and TRuE-AD2 were included in the NDA.

    Incyte submitted a priority review voucher (PRV) along with the NDA application for ruxolitinib cream. The use of the PRV shortens the review period by four months. The Prescription Drug User Fee Act (PDUFA) target action date is June 21, 2021.

    About Atopic Dermatitis

    Atopic dermatitis (AD) is a chronic skin disease, affecting more than 21 million people in the United States and is characterized by inflammation and intense itch. Signs and symptoms of AD include irritated and itchy skin that can cause red lesions that may ooze and crust. Patients with AD are also more susceptible to bacterial, viral and fungal infections.

    About TRuE-AD

    The TRuE-AD clinical trial program consists of two randomized, double-blind, vehicle-controlled Phase 3 studies, TRuE-AD1 (NCT03745638) and TRuE-AD2 (NCT03745651), evaluating the safety and efficacy of ruxolitinib cream compared to vehicle (non-medicated cream) in patients with atopic dermatitis (AD). Both studies enrolled more than 600 patients (age ≥12 years) diagnosed with AD for at least two years and who were candidates for topical therapy.

    Patients with an Investigator's Global Assessment (IGA) score of 2 to 3, and with AD on 3% to 20% of their Body Surface Area (excluding scalp) were randomized 2:2:1 into one of three arms for eight weeks: ruxolitinib cream 0.75% applied twice daily (BID); ruxolitinib cream 1.5% applied BID; and vehicle. Participants who successfully completed an assessment at Week 8 were offered participation in the 44-week long-term safety treatment extension period with ruxolitinib cream 0.75% or 1.5% applied BID.

    The primary endpoint of the TRuE-AD studies was the proportion of participants achieving an Investigator's Global Assessment Treatment Success (IGA-TS), defined as an IGA score of 0 (clear) or 1 (almost clear) with at least a 2-point improvement from baseline at Week 8. Key secondary endpoints include: the proportion of patients achieving at least a 75% improvement from baseline in the Eczema Area and Severity Index (EASI-75) score, the proportion of participants with at least a 4-point improvement in the itch Numerical Rating Scale, and the proportion of participants with at least a 6-point improvement in the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form – Sleep Disturbance (8b) 24-hour recall score. Additional secondary endpoints include mean percentage change from baseline in Scoring Atopic Dermatitis (SCORAD) score. The studies have also been tracking the frequency, duration and severity of adverse events associated with the use of ruxolitinib cream.

    TRuE-AD results presented at the 29th European Academy of Dermatology and Venereology (EADV) Congress in October 2020 examined sleep quality, sleep depth and restoration associated with sleep, key quality of life measures for people with AD.

    For more information about the TRuE-AD studies, please visit http://clinicaltrials.gov/ct2/show/NCT03745638 and http://clinicaltrials.gov/ct2/show/NCT03745651.

    About Ruxolitinib Cream

    Ruxolitinib cream is a proprietary formulation of Incyte's selective JAK1/JAK2 inhibitor ruxolitinib that has been designed for topical application. Ruxolitinib cream is currently in Phase 3 development for the treatment of atopic dermatitis (TRuE-AD) and for the treatment of adolescents and adults with vitiligo (TRuE-V). Incyte has worldwide rights for the development and commercialization of ruxolitinib cream.

    About Incyte Dermatology

    Incyte's science-first approach and expertise in immunology has formed the foundation of the company. In Dermatology, the Company's research and development efforts are focused on leveraging our knowledge of the JAK-STAT pathway to identify and develop topical and oral therapies with the potential to modulate immune pathways driving uncontrolled inflammation and help restore normal immune function.

    Currently, Incyte is exploring the potential of JAK inhibition for a number of immune-mediated dermatologic conditions with a high unmet medical need, including atopic dermatitis, vitiligo and hidradenitis suppurativa. To learn more, visit the Dermatology section of Incyte.com.

    About Incyte

    Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

    Forward-Looking Statements

    Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the Company's ongoing clinical development program for ruxolitinib cream as well as its dermatology program generally, and whether and when ruxolitinib cream will be approved for use in the U.S. or elsewhere for atopic dermatitis or any other indication, contain predictions, estimates and other forward-looking statements.

    These forward-looking statements are based on the Company'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: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by the FDA; the Company's dependence on its relationships with its collaboration partners; the efficacy or safety of the Company's products and the products of the Company's collaboration partners; the acceptance of the Company's products and the products of the Company's collaboration partners in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; greater than expected expenses; expenses relating to litigation or strategic activities; and other risks detailed from time to time in the Company's reports filed with the Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2020. The Company disclaims any intent or obligation to update these forward-looking statements.

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  4. Incyte (NASDAQ:INCY) announced today that it will present at the virtual Cowen 41st Annual Health Care Conference on Wednesday, March 3, 2021 at 2:00 p.m. EST.

    The presentation will be webcast live and can be accessed at Investor.Incyte.com and will be available for replay for 90 days.

    About Incyte

    Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

    Incyte (NASDAQ:INCY) announced today that it will present at the virtual Cowen 41st Annual Health Care Conference on Wednesday, March 3, 2021 at 2:00 p.m. EST.

    The presentation will be webcast live and can be accessed at Investor.Incyte.com and will be available for replay for 90 days.

    About Incyte

    Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

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  5. - Total FY revenues of $2.67 billion (+24% y/y); total FY product and royalty revenues increased 18% to $2.46 billion; three new FDA approvals in 2020

    - Jakafi®(ruxolitinib) FY revenue increased to $1.94 billion (+15% y/y); Jakafi® guidance range of $2.125 to $2.20 billion for 2021

    - Successful launches of Monjuvi®(tafasitamab-cxix) and Pemazyre® (pemigatinib) in the U.S.

    - Opportunities for additional growth provided by broad late-stage pipeline, with the potential approval of ruxolitinib cream for atopic dermatitis in the U.S. and six other regulatory approval decisions expected across the U.S., EU and Japan during 2021

    Conference Call and Webcast Scheduled Today at 8:00 a.m. EDT

    Incyte (NASDAQ:INCY) today reports 2020 fourth quarter…

    - Total FY revenues of $2.67 billion (+24% y/y); total FY product and royalty revenues increased 18% to $2.46 billion; three new FDA approvals in 2020

    - Jakafi®(ruxolitinib) FY revenue increased to $1.94 billion (+15% y/y); Jakafi® guidance range of $2.125 to $2.20 billion for 2021

    - Successful launches of Monjuvi®(tafasitamab-cxix) and Pemazyre® (pemigatinib) in the U.S.

    - Opportunities for additional growth provided by broad late-stage pipeline, with the potential approval of ruxolitinib cream for atopic dermatitis in the U.S. and six other regulatory approval decisions expected across the U.S., EU and Japan during 2021

    Conference Call and Webcast Scheduled Today at 8:00 a.m. EDT

    Incyte (NASDAQ:INCY) today reports 2020 fourth quarter and full year financial results, and provides a status update on the Company's development portfolio.

    "Our team achieved many important accomplishments in the past year. Revenue growth was strong, driven by demand for Jakafi® (ruxolitinib), and the launches of Monjuvi® (tafasitamab-cxix) and Pemazyre® (pemigatinib) continue to gain momentum. During 2020, we also announced positive results across multiple late-stage programs, including the pivotal trials of ruxolitinib in chronic GVHD, ruxolitinib cream in atopic dermatitis, parsaclisib in NHL, and retifanlimab in SCAC," stated Hervé Hoppenot, Chief Executive Officer, Incyte. "During 2021, we expect regulatory decisions on seven applications seeking approval, including four in the U.S, two in Europe and one in Japan, and we are working towards the potential U.S. launch of ruxolitinib cream, which we expect to be approved by the FDA in the middle of the year."

    Portfolio Updates

    MPNs and GVHD – key highlights

    Our LIMBER development program, to improve patient outcomes in MPNs and GHVD, is progressing well.

    The two Phase 3 trials of ruxolitinib in combination with parsaclisib are both underway, evaluating the combination versus monotherapy ruxolitinib as a first-line therapy for patients with myelofibrosis (MF) (LIMBER-313) and as a therapy for MF patients with a suboptimal response to ruxolitinib monotherapy (LIMBER-304).

    Monotherapy trials of INCB57643 (BET) and INCB00928 (ALK2) are underway, and are expected to lead to proof-of-concept combination trials of both agents with ruxolitinib in patients with myelofibrosis. A monotherapy trial of itacitinib (JAK1) in patients previously treated with ruxolitinib is ongoing.

    In December 2020, Incyte and Cellenkos announced a development collaboration to investigate the combination of ruxolitinib and CK0804, Cellenkos' cryopreserved CXCR4 enriched, allogeneic, umbilical cord blood-derived T-regulatory cells, in patients with myelofibrosis. In addition, Incyte obtained an exclusive option to acquire sole rights to develop and commercialize CK0804, and genetically-modified variants of CK0804, in benign and malignant hematology indications.

    The sNDA seeking approval of Jakafi in steroid-refractory chronic graft-versus-host disease (GVHD) has been submitted, based on data from the successful results of the REACH3 trial, which were presented at ASH 2020.

    Indication and status

     

    Once-a-day ruxolitinib

    (JAK1/JAK2)

    Myelofibrosis, polycythemia vera & GVHD: clinical pharmacology studies

    ruxolitinib + parsaclisib

    (JAK1/JAK2 + PI3Kδ)

    Myelofibrosis: Phase 3 (first-line therapy) (LIMBER-313)

    Myelofibrosis: Phase 3 (suboptimal responders to ruxolitinib) (LIMBER-304)

     

    ruxolitinib + INCB57643

    (JAK1/JAK2 + BET)

    Myelofibrosis: Phase 2 in preparation

    ruxolitinib + INCB00928

    (JAK1/JAK2 + ALK2)

    Myelofibrosis: Phase 2 in preparation

    itacitinib

    (JAK1)

    Myelofibrosis: Phase 2 (low platelets)

    ruxolitinib + CK08041

    (JAK1/JAK2 + CB-Tregs)

    Myelofibrosis: PoC in preparation

    ruxolitinib

    (JAK1/JAK2)

    Steroid-refractory chronic GVHD2: sNDA submitted

     

    itacitinib

    (JAK1)

    Treatment-naïve chronic GVHD: Phase 3 (GRAVITAS-309)

     

    1. Development collaboration with Cellenkos
    2. Clinical development of ruxolitinib in GVHD conducted in collaboration with Novartis

    Other Hematology/Oncology – key highlights

    Momentum is strong behind the U.S. launch of Monjuvi (tafasitamab-cxix), with good uptake in both academic and community settings and illustrated by the market share gained in the first several months since launch.

    The Phase 3 inMIND trial evaluating tafasitamab plus lenalidomide and rituximab (R-squared) versus R-squared in patients with relapsed or refractory follicular or marginal zone lymphoma is open for recruitment, and the Phase 3 frontMIND trial of tafasitamab plus lenalidomide and R-CHOP versus R-CHOP as a first-line treatment in patients with DLBCL is expected to open in the coming months.

    The U.S. launch of Pemazyre (pemigatinib) has been successful and, in January, Incyte announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending the conditional marketing authorization of pemigatinib for the treatment of adults with unresectable locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or rearrangement that is relapsed or refractory, after at least one line of systemic therapy.

    In December 2020, data from three ongoing Phase 2 studies evaluating parsaclisib for the treatment of patients with relapsed or refractory follicular (CITADEL-203), marginal zone (CITADEL-204) and mantle cell (CITADEL-205) lymphomas were presented at ASH 2020. Data from the CITADEL program are expected to form the basis of an NDA seeking FDA approval of parsaclisib, which is expected to be submitted in the second half of 2021.

    In January 2021, Incyte announced that the FDA had accepted for Priority Review its Biologics License Application (BLA) for retifanlimab as a treatment for previously treated patients with advanced squamous cell anal carcinoma (SCAC) who have progressed following standard platinum-based chemotherapy. The BLA submission was based on data from the Phase 2 POD1UM-202 trial evaluating retifanlimab in previously treated patients with advanced SCAC who have progressed following standard platinum-based chemotherapy; the Phase 3 POD1UM-303 trial in patients with SCAC is underway.

     

    Indication and status

     

    pemigatinib

    (FGFR1/2/3)

    CCA: Phase 2 (FIGHT-202), Phase 3 (FIGHT-302); J-NDA under review

    8p11 MPN: Phase 2 (FIGHT-203)

    Tumor agnostic: Phase 2 (FIGHT-207)

     

    tafasitamab

    (CD19)1

    r/r DLBCL: Phase 2 (L-MIND); Phase 3 (B-MIND); MAA under review

    1L DLBCL: Phase 1b (firstMIND); Phase 3 (frontMIND) in preparation

    r/r FL and r/r MZL: Phase 3 (inMIND) open for recruitment

    r/r B-cell malignancies: PoC with parsaclisib (PI3Kδ) in preparation

    r/r B-cell malignancies: PoC with lenalidomide and plamotamab in preparation2

     

    parsaclisib

    (PI3Kδ)

    r/r follicular lymphoma: Phase 2 (CITADEL-203)

    r/r marginal zone lymphoma: Phase 2 (CITADEL-204)

    r/r mantle cell lymphoma: Phase 2 (CITADEL-205)

     

    retifanlimab

    (PD-1)3

    SCAC: Phase 2 (POD1UM-202); Phase 3 (POD1UM-303); BLA under review

    MSI-high endometrial cancer: Phase 2 (POD1UM-101, POD1UM-204)

    Merkel cell carcinoma: Phase 2 (POD1UM-201)

    NSCLC: Phase 3 (POD1UM-304)

     

    CCA = cholangiocarcinoma; DLBCL = diffuse large B-cell lymphoma; SCAC = squamous cell anal carcinoma; FL = follicular lymphoma; MZL = marginal zone lymphoma

    1. Development of tafasitamab in collaboration with MorphoSys
    2. Clinical collaboration with MorphoSys and Xencor, Inc. to investigate the combination of tafasitamab plus lenalidomide in combination with Xencor's CD20xCD3 XmAb bispecific antibody, plamotamab.
    3. retifanlimab licensed from MacroGenics

    Incyte's emerging clinical candidates in hematology/oncology include INCB86550, the first in a series of selective oral inhibitors of PD-L1; INCB81776, a dual AXL/MER inhibitor; INCB106385, an adenosine (A2A/A2B) inhibitor and, via a collaboration with Merus, MCLA-145, a PD-L1xCD137 bispecific antibody.

    Inflammation and Autoimmunity (IAI) – key highlights

    Dermatology

    As planned, the NDA seeking approval of ruxolitinib cream as a treatment for patients with atopic dermatitis was submitted to the FDA late in the fourth quarter of 2020, including use of the previously acquired priority review voucher (PRV). The use of the PRV is expected to accelerate the time to an FDA decision.

    Recruitment has been completed in both Phase 3 trials in the TRuE-V development program evaluating ruxolitinib cream as a treatment for patients with vitiligo, and topline results are expected to be announced in the first half of 2021. If successful, data from TRuE-V are expected to form the basis of an sNDA seeking approval of ruxolitinib cream as a treatment for patients with vitiligo, which would be submitted as soon as practicable after the FDA decision on the atopic dermatitis NDA.

     

    Indication and status

     

    ruxolitinib cream

    (JAK1/JAK2)

    Atopic dermatitis: NDA submitted

    Vitiligo: Phase 3 (TRuE-V1, TRuE-V2; recruitment complete in both trials)

    INCB54707

    (JAK1)

    Hidradenitis suppurativa: Phase 2b

     

    parsaclisib

    (PI3Kδ)

    Autoimmune hemolytic anemia: Phase 2

     

    INCB00928

    (ALK2)

    Fibrodysplasia ossificans progressiva: Phase 2 in preparation

    Partnered – key highlights

    In December 2020, Incyte and Lilly announced that Olumiant had been approved in Japan as a treatment of patients with atopic dermatitis who have inadequate response to conventional therapies.

     

    Indication and status

     

    baricitinib

    (JAK1/JAK2)1

    Atopic dermatitis: Phase 3 (BREEZE-AD); approved in EU and Japan

    Systemic lupus erythematosus: Phase 3 (BRAVE I, BRAVE II)

    Severe alopecia areata: Phase 3 (BRAVE-AA1, BRAVE-AA2)

    capmatinib

    (MET)2

    NSCLC (with MET exon 14 skipping mutations): Approved as Tabrecta in U.S. and Japan

     

    1. Worldwide rights to baricitinib licensed to Lilly: approved as Olumiant in multiple territories globally for certain patients with moderate-to-severe rheumatoid arthritis; approved as Olumiant in EU and Japan for certain patients with atopic dermatitis
    2. Worldwide rights to capmatinib licensed to Novartis

    Potential therapies for patients with COVID-19

    In November 2020, Incyte and Lilly announced that the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the distribution and emergency use of baricitinib to be used in combination with remdesivir in hospitalized adult and pediatric patients two years of age or older with suspected or laboratory confirmed COVID-19 who require supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation.

    In December 2020, the New England Journal of Medicine published peer-reviewed results from the Adaptive COVID-19 Treatment Trial (ACTT-2) sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The Phase 3 study included 1,033 patients from 67 trial sites in eight countries. These results supported the EUA issued by the FDA.

    Status

    ruxolitinib

    (JAK1/JAK2)

    COVID-19 associated cytokine storm: Phase 3 (369-DEVENT)

     

    baricitinib

    (JAK1/JAK2)1

    Hospitalized patients with COVID-19: Phase 3 (COV-BARRIER)

     

    1. Worldwide rights to baricitinib licensed to Lilly: approved as Olumiant in multiple territories globally for certain patients with moderate-to-severe rheumatoid arthritis; approved as Olumiant in EU and Japan for certain patients with atopic dermatitis

    2020 Fourth Quarter and Year-End Financial Results

    The financial measures presented in this press release for the quarter and year ended December 31, 2020 and 2019 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.

    Financial Highlights

    Financial Highlights

    (unaudited, in thousands, except per share amounts)

     

    Three Months Ended

    Twelve Months Ended

    December 31,

    December 31,

     

    2020

     

     

    2019

     

    2020

     

     

    2019

    Total GAAP revenue

    $

    789,509

    $

    579,389

    $

    2,666,702

     

    $

    2,158,759

     

    Total GAAP operating income (loss)

     

    164,229

     

    95,008

     

    (263,676

    )

     

    402,006

    Total Non-GAAP operating income (loss)

     

    218,469

     

    145,538

     

    (40,878

    )

     

    609,812

    GAAP net income (loss)

     

    149,850

     

    111,005

     

    (295,697

    )

     

    446,906

    Non-GAAP net income (loss)

     

    204,773

     

    141,936

     

    (90,510

    )

     

    615,459

     

    GAAP basic EPS

    $

    0.68

    $

    0.51

    $

    (1.36

    )

    $

    2.08

    Non-GAAP basic EPS

    $

    0.93

    $

    0.66

    $

    (0.42

    )

    $

    2.86

    GAAP diluted EPS

    $

    0.68

    $

    0.51

    $

    (1.36

    )

    $

    2.05

    Non-GAAP diluted EPS

    $

    0.93

    $

    0.65

    $

    (0.42

    )

    $

    2.83

    Revenue Details

    Revenue Details

    (unaudited, in thousands)

     

    Three Months Ended

    Twelve Months Ended

    December 31,

    %

    December 31,

    %

     

    2020

     

     

    2019

    Change

     

    2020

     

    2019

    Change

    Revenues:

    Jakafi net product revenues

    $

    516,882

    $

    466,464

    11%

    $

    1,937,850

    $

    1,684,968

    15%

    Iclusig net product revenues

     

    28,576

     

    24,314

    18%

     

    105,002

     

    89,954

    17%

    Pemazyre net product revenues

     

    14,009

     

    -

    NM

     

    25,884

     

    -

    NM

    Jakavi product royalty revenues

     

    87,046

     

    65,007

    34%

     

    277,902

     

    225,913

    23%

    Olumiant product royalty revenues

     

    30,996

     

    23,604

    31%

     

    110,920

     

    80,424

    38%

    Tabrecta product royalty revenues

     

    2,000

     

    -

    NM

     

    4,144

     

    -

    NM

    Product and royalty revenues

     

    679,509

     

    579,389

    17%

     

    2,461,702

     

    2,081,259

    18%

    Milestone and contract revenues

     

    110,000

     

    -

    NM

     

    205,000

     

    77,500

    NM

    Total GAAP revenues

    $

    789,509

    $

    579,389

    36%

    $

    2,666,702

    $

    2,158,759

    24%

    NM = not meaningful

    Product and Royalty Revenues Product and royalty revenues for the quarter and year ended December 31, 2020 increased 17% and 18%, respectively, over the prior year comparative periods primarily as a result of increases in Jakafi net product revenues, the launch of Pemazyre and higher product royalty revenues from Jakavi and Olumiant. Jakafi net product revenues for the quarter and year ended December 31, 2020 increased 11% and 15%, respectively, over the prior year comparative periods, primarily driven by growth in patient demand across all indications.

    Operating Expenses

    Operating Expense Summary

    (unaudited, in thousands)

     

    Three Months Ended

    Twelve Months Ended

    December 31,

    %

    December 31,

    %

     

    2020

     

    2019

    Change

     

    2020

     

    2019

    Change

    GAAP cost of product revenues

    $

    36,323

    $

    32,215

    13%

    $

    131,328

    $

    114,249

    15%

    Non-GAAP cost of product revenues1

     

    30,693

     

    26,658

    15%

     

    108,830

     

    92,015

    18%

     

    GAAP research and development

     

    405,945

     

    312,867

    30%

     

    2,215,942

     

    1,154,111

    92%

    Non-GAAP research and development2

     

    375,770

     

    284,389

    32%

     

    2,095,586

     

    1,040,169

    101%

     

    GAAP selling, general and administrative

     

    166,988

     

    136,177

    23%

     

    516,922

     

    468,711

    10%

    Non-GAAP selling, general and administrative3

     

    152,148

     

    122,804

    24%

     

    460,363

     

    416,763

    10%

     

    GAAP change in fair value of acquisition-related contingent consideration

     

    3,595

     

    3,122

    15%

     

    23,385

     

    19,682

    19%

    Non-GAAP change in fair value of acquisition-related contingent consideration4

     

    -

     

    -

     

    -

     

    -

     

    GAAP collaboration loss sharing

     

    12,429

     

    -

    NM

     

    42,801

     

    -

    NM

    Non-GAAP collaboration loss sharing

     

    12,429

     

    -

    NM

     

    42,801

     

    -

    NM

    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.

    3. Non-GAAP selling, general and administrative expenses exclude the cost of stock-based compensation.

    4. Non-GAAP change in fair value of acquisition-related contingent consideration is null.

    Research and development expenses GAAP and Non-GAAP research and development expense for the quarter ended December 31, 2020 increased 30% and 32%, respectively, compared to the same period in 2019 primarily due to our 55% share of the global and U.S. specific development costs for tafasitamab, product supply related costs to support the potential launch of ruxolitinib cream as a treatment for atopic dermatitis in 2021 and an increase in upfront and milestone payments under our collaborative agreements. Excluding the $42 million impact of product supply costs and the upfront and milestone payments, research and development expense for the quarter ended December 31, 2020 increased approximately 17% compared to the same period in 2019.

    For the year ended December 31, 2020, GAAP and Non-GAAP research and development expense increased 92% and 101%, respectively, compared to the year ended December 31, 2019 primarily due to higher upfront and milestone payments under our collaborative agreements which includes upfront consideration of $805 million related to our collaborative agreement with MorphoSys, $120 million of expense related to the purchase of an FDA priority review voucher ("PRV") utilized to accelerate the FDA review of ruxolitinib cream in atopic dermatitis, our 55% share of the global and U.S. specific development costs for tafasitamab, and product supply costs to support the potential launch of ruxolitinib cream. Excluding the $1.02 billion impact of upfront consideration and milestone payments, purchase of the PRV and product supply related costs, research and development expense for the year ended December 31, 2020 increased approximately 4% compared with the prior year period.

    Selling, general and administrative expenses GAAP and Non-GAAP selling, general and administrative expenses for the quarter ended December 31, 2020 increased 23% and 24%, respectively, compared to the same period in 2019, primarily due to the timing of certain expenses. GAAP and Non-GAAP selling, general and administrative expenses for the year ended December 31, 2020 increased 10% compared to the year ended December 31, 2019 primarily due to an increase in sales and marketing spend to support the commercialization of Pemazyre in the US and to prepare for the potential launch of ruxolitinib cream in the U.S. and pemigatinib and tafasitamab in the EU.

    Other Financial Information

    Operating income (loss) GAAP and Non-GAAP operating income for the quarter ended December 31, 2020 increased compared to the same period in 2019, due to the growth in total revenues exceeding the growth in operating expenses. For the year ended December 31, 2020, Incyte recorded an operating loss compared to operating income for the same period in 2019, on both a GAAP and Non-GAAP basis, primarily due to upfront consideration related to our collaboration with MorphoSys and expense related to the PRV, partially offset by the growth in product and royalty revenues.

    Cash, cash equivalents and marketable securities position As of December 31, 2020 and 2019, cash, cash equivalents and marketable securities totaled $1.8 billion and $2.1 billion, respectively. The decrease is primarily due to the upfront payment and stock purchase related to our collaborative agreement with MorphoSys and purchase of the PRV, partially offset by the cash flow generated in 2020.

    2021 Financial Guidance

    Due to the continuing growth and diversification of Incyte's commercial product portfolio, 2021 net product revenue guidance is being provided for Jakafi and in total for other Hematology/Oncology products, which currently include Iclusig in Europe and Pemazyre in the U.S. Guidance does not include revenue from any potential new product launches. However, GAAP and Non-GAAP selling, general and administrative expense guidance for 2021 includes costs to support the potential launches of ruxolitinib cream as a treatment for atopic dermatitis in the U.S., pemigatinib as a treatment for cholangiocarcinoma in the EU and Japan, and tafasitamab as a treatment for DLBCL in the EU. The 2021 financial guidance does not include the impact of any potential future strategic transactions.

    Jakafi net product revenues

     

    $2,125 - $2,200 million

    Other Hematology/Oncology net product revenues

    $145 - $160 million

    GAAP Cost of product revenues

     

    6 – 7% of net product revenues

    Non-GAAP Cost of product revenues(1)

     

    5 – 6% of net product revenues

    GAAP Research and development expenses

     

    $1,350 - $1,390 million

    Non-GAAP Research and development expenses(2)

     

    $1,220 - $1,250 million

    GAAP Selling, general and administrative expenses

    $735 - $775 million

    Non-GAAP Selling, general and administrative expenses(2)

     

    $665 - $700 million

    (1) Adjusted 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.

    (2) 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. EDT. 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, 13715042.

    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, 13715042.

    The conference call will also be webcast; the livestream and the replay can be accessed at investor.incyte.com.

    About Incyte

    Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics.

    For additional information on Incyte, please visit Incyte.com and follow @Incyte.

    About Jakafi® (ruxolitinib)

    Jakafi is a first-in-class JAK1/JAK2 inhibitor approved by the U.S. FDA for treatment of steroid-refractory acute GVHD in adult and pediatric patients 12 years and older.

    Jakafi is also indicated for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea as well as adults with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF.

    Jakafi is marketed by Incyte in the United States and by Novartis as Jakavi® (ruxolitinib) outside the United States. Jakafi is a registered trademark of Incyte Corporation. Jakavi is a registered trademark of Novartis AG in countries outside the United States.

    About Monjuvi® (tafasitamab-cxix)

    Monjuvi 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).

    Monjuvi is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).  

    In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. Monjuvi is being co-commercialized by Incyte and MorphoSys in the United States. Incyte has exclusive commercialization rights outside the United States.

    A marketing authorization application (MAA) seeking the approval of tafasitamab in combination with lenalidomide in the EU has been validated by the European Medicines Agency (EMA) and is currently under review for the treatment of adult patients with relapsed or refractory DLBCL, including DLBCL arising from low grade lymphoma, who are not candidates for ASCT.

    Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in a number of ongoing combination trials.

    Monjuvi is a registered trademark of MorphoSys AG. XmAb® is a registered trademark of Xencor, Inc.

    About Pemazyre® (pemigatinib)

    Pemazyre 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 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. Incyte has granted Innovent Biologics, Inc. rights to develop and commercialize pemigatinib in hematology and oncology in Mainland China, Hong Kong, Macau and Taiwan. Incyte has retained all other rights to develop and commercialize pemigatinib outside of the United States.

    Additionally, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the conditional marketing authorization of pemigatinib for the treatment of adults with unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that is relapsed or refractory, after at least one line of systemic therapy.

    Pemazyre is a trademark of Incyte Corporation.

    About Iclusig® (ponatinib) tablets

    Iclusig 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.

    Incyte has an exclusive license from ARIAD Pharmaceuticals, Inc., since acquired by Takeda Pharmaceutical Company Limited, to develop and commercialize Iclusig in the European Union and 22 other countries, including Switzerland, Norway, Turkey, Israel and Russia.

    Forward-Looking Statements

    Except for the historical information set forth herein, the matters set forth in this release contain predictions, estimates and other forward-looking statements, including without limitation statements regarding expectations for up to seven drug application approvals in 2021 in the U.S, Europe and Japan; the Company's ongoing clinical development program for ruxolitinib cream as well as its dermatology program generally; whether and when ruxolitinib cream will be approved in the U.S. or elsewhere for atopic dermatitis and the extent of our launch readiness; the expected timing of receipt and announcement of results for ruxolitinib cream for vitiligo; continued development of our LIMBER program, including expectations for, and timing and results of, ruxolitinib combination trials with parsaclisib; expectations for our monotherapy trials for INCB57643 (BET), and INCB00928 (ALK2); our collaboration with Cellenkos investigating the combination of ruxolitinib and CK0804; whether and when Jakafi will be approved in the U.S. or elsewhere for steroid-refractory chronic graft-versus-host disease (GVHD); whether and when the BLA for retifanlimab for SCAC will be approved; expectations for tafasitamab development, including the inMIND and frontMIND trials and plans to further broaden the development program of tafasitamab in other B-cell malignancies and clinical trial plans for such program; whether or when the European Commission will grant marketing authorization for pemigatinib in Europe; plans for ongoing and further development of parsaclisib in the CITADEL program and the planned timing of an NDA submission based on that program; and the expected timing of receipt and announcement of clinical trial results for INCB86550; and our financial guidance for 2021 and the expectations underlying such guidance.

    These forward-looking statements are based on the Company'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:; the actual time required by the FDA to review the Company's NDA for approval for ruxolitinib cream in atopic dermatitis, the Company's sNDA for Jakafi in steroid-refractory chronic graft-versus-host disease (GVHD) and the Company's BLA for retifanlimab in SCAC, and the results of such reviews; further research and development and the results of clinical trials possibly being unsuccessful 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; the effects of the COVID-19 pandemic and measures to address the pandemic on the Company's clinical trials, supply chain and other third-party providers, sales and marketing efforts, and business, development and discovery operations; determinations made by the FDA and regulatory agencies outside of the United States; the Company's dependence on its relationships with and changes in the plans of its collaboration partners; the efficacy or safety of the Company's products and the products of the Company's collaboration partners; the acceptance of the Company's products and the products of the Company's collaboration partners in the marketplace; market competition; unexpected variations in the demand for the Company's products and the products of the Company's collaboration partners; the effects of announced or unexpected price regulation or limitations on reimbursement or coverage for the Company's products and the products of the Company's collaboration partners; sales, marketing, manufacturing and distribution requirements, including the Company'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; and other risks detailed from time to time in the Company's reports filed with the Securities and Exchange Commission, including its quarterly report on Form 10-Q for the quarter ended September 30, 2020. The Company disclaims any intent or obligation to update these forward-looking statements.

    INCYTE CORPORATION

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (unaudited, in thousands, except per share amounts)

     

    Three Months Ended

    Twelve Months Ended

    December 31,

    December 31,

     

    2020

     

     

    2019

     

     

    2020

     

     

    2019

     

    GAAP

    GAAP

    Revenues:

    Product revenues, net

    $

    559,467

     

    $

    490,778

     

    $

    2,068,736

     

    $

    1,774,922

     

    Product royalty revenues

     

    120,042

     

     

    88,611

     

     

    392,966

     

     

    306,337

     

    Milestone and contract revenues

     

    110,000

     

     

    -

     

     

    205,000

     

     

    77,500

     

    Total revenues

     

    789,509

     

     

    579,389

     

     

    2,666,702

     

     

    2,158,759

     

     

    Costs and expenses:

    Cost of product revenues (including definite-lived intangible amortization)

     

    36,323

     

     

    32,215

     

     

    131,328

     

     

    114,249

     

    Research and development

     

    405,945

     

     

    312,867

     

     

    2,215,942

     

     

    1,154,111

     

    Selling, general and administrative

     

    166,988

     

     

    136,177

     

     

    516,922

     

     

    468,711

     

    Change in fair value of acquisition-related contingent consideration

     

    3,595

     

     

    3,122

     

     

    23,385

     

     

    19,682

     

    Collaboration loss sharing

     

    12,429

     

     

    -

     

     

    42,801

     

     

    -

     

    Total costs and expenses

     

    625,280

     

     

    484,381

     

     

    2,930,378

     

     

    1,756,753

     

     

    Income (loss) from operations

     

    164,229

     

     

    95,008

     

     

    (263,676

    )

     

    402,006

     

    Other income (expense), net

     

    4,810

     

     

    15,848

     

     

    23,206

     

     

    52,182

     

    Interest expense

     

    (428

    )

     

    (607

    )

     

    (2,174

    )

     

    (1,855

    )

    Unrealized gain (loss) on long term investments

     

    (509

    )

     

    15,755

     

     

    10,426

     

     

    34,458

     

    Income (loss) before provision for income taxes

     

    168,102

     

     

    126,004

     

     

    (232,218

    )

     

    486,791

     

    Provision for income taxes

     

    18,252

     

     

    14,999

     

     

    63,479

     

     

    39,885

     

    Net income (loss)

    $

    149,850

     

    $

    111,005

     

    $

    (295,697

    )

    $

    446,906

     

     

    Net income (loss) per share:

    Basic

    $

    0.68

     

    $

    0.51

     

    $

    (1.36

    )

    $

    2.08

     

    Diluted

    $

    0.68

     

    $

    0.51

     

    $

    (1.36

    )

    $

    2.05

     

     

    Shares used in computing net income (loss) per share:

    Basic

     

    219,239

     

     

    215,770

     

     

    218,073

     

     

    214,913

     

    Diluted

     

    221,228

     

     

    218,542

     

     

    218,073

     

     

    217,657

     

    INCYTE CORPORATION

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (unaudited, in thousands)

     

    December 31,

    December 31,

    2020

    2019

    ASSETS

    Cash, cash equivalents and marketable securities

    $

    1,801,377

    $

    2,117,554

    Accounts receivable

     

    481,994

     

    308,809

    Property and equipment, net

     

    559,625

     

    377,567

    Finance lease right-of-use assets, net

     

    28,451

     

    29,058

    Inventory

     

    35,973

     

    16,505

    Prepaid expenses and other assets

     

    103,313

     

    94,179

    Long term investments

     

    222,301

     

    133,657

    Other intangible assets, net

     

    172,291

     

    193,828

    Goodwill

     

    155,593

     

    155,593

    Total assets

    $

    3,560,918

    $

    3,426,750

     

    LIABILITIES AND STOCKHOLDERS' EQUITY

    Accounts payable, accrued expenses and other liabilities

    $

    648,793

    $

    500,462

    Finance lease liabilities

     

    34,857

     

    32,582

    Convertible senior notes

     

    -

     

    18,300

    Acquisition-related contingent consideration

     

    266,000

     

    277,000

    Stockholders' equity

     

    2,611,268

     

    2,598,406

    Total liabilities and stockholders' equity

    $

    3,560,918

    $

    3,426,750

    INCYTE CORPORATION

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

    (unaudited, in thousands, except per share amounts)

     

    Three Months Ended

    Twelve Months Ended

    December 31,

    December 31,

    2020

    2019

    2020

    2019

     

    GAAP Net Income (Loss)

    $

    149,850

    $

    111,005

     

    $

    (295,697

    )

    $

    446,906

     

    Adjustments1:

    Non-cash stock compensation from equity awards (R&D)2

     

    30,175

     

    28,478

     

     

    120,356

     

     

    113,942

     

    Non-cash stock compensation from equity awards (SG&A)2

     

    14,840

     

    13,373

     

     

    56,559

     

     

    51,948

     

    Non-cash stock compensation from equity awards (COGS)2

     

    246

     

    173

     

     

    962

     

     

    698

     

    Non-cash interest expense related to convertible notes3

     

    66

     

    221

     

     

    683

     

     

    867

     

    Changes in fair value of equity investments4

     

    509

     

    (15,755

    )

     

    (10,426

    )

     

    (34,458

    )

    Amortization of acquired product rights5

     

    5,384

     

    5,384

     

     

    21,536

     

     

    21,536

     

    Change in fair value of contingent consideration6

     

    3,595

     

    3,122

     

     

    23,385

     

     

    19,682

     

    Tax effect of Non-GAAP adjustments7

     

    108

     

    (4,065

    )

     

    (7,868

    )

     

    (5,662

    )

    Non-GAAP Net Income (Loss)

    $

    204,773

    $

    141,936

     

    $

    (90,510

    )

    $

    615,459

     

     

    Non-GAAP net income (loss) per share:

    Basic

    $

    0.93

    $

    0.66

     

    $

    (0.42

    )

    $

    2.86

     

    Diluted

    $

    0.93

    $

    0.65

     

    $

    (0.42

    )

    $

    2.83

     

     

    Shares used in computing Non-GAAP net income (loss) per share:

    Basic

     

    219,239

     

    215,770

     

     

    218,073

     

     

    214,913

     

    Diluted

     

    221,228

     

    218,542

     

     

    218,073

     

     

    217,657

     

    1. Included within the Milestone and contract revenues line item in the Condensed Consolidated Statements of Operations (in thousands) for the three and twelve months ended December 31, 2020 are milestones of $110,000 and $205,000, respectively, earned from our collaborative partners as compared to upfront consideration and milestones of $0 and $77,500, respectively, for the same periods in 2019. Included within the Research and development expenses line item in the Condensed Consolidated Statements of Operations (in thousands) for the three and twelve months ended December 31, 2020 are upfront consideration and milestones of $25,600 and $976,082, respectively, related to our collaborative partners and FDA priority review voucher as compared to $2,500 and $27,500, respectively, for the same periods in 2019.

    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 Unrealized gain (loss) on long term 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 Change in fair value of acquisition-related contingent consideration line item in the Condensed Consolidated Statements of Operations.

    7. As included within the Provision for income taxes line item in the Condensed Consolidated Statements of Operations. Income tax effects of Non-GAAP adjustments are calculated using the applicable statutory tax rate for the jurisdictions in which the charges are incurred, while taking into consideration any valuation allowances.

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