INCY Incyte Corporation

82.27
-3.15  -4%
Previous Close 85.42
Open 85.61
52 Week Low 62.48
52 Week High 110.365
Market Cap $18,016,808,324
Shares 218,996,090
Float 185,570,536
Enterprise Value $16,554,063,492
Volume 1,069,543
Av. Daily Volume 1,201,618
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Upcoming Catalysts

Drug Stage Catalyst Date
Jakafi
Myelofibrosis
Approved
Approved
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Pelareorep and retifanlimab (INCMGA00012) - IRENE
Triple-negative breast cancer.
Phase 2
Phase 2
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Parsaclisib INCB50465 (CITADEL-203)
Follicular lymphoma
Phase 2
Phase 2
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Ruxolitinib (Jakafi)
COVID-19 associated cytokine storm
Phase 3
Phase 3
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Ruxolitinib - TRuE-AD1
Atopic dermatitis
NDA Filing
NDA Filing
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Baricitinib
Systemic lupus erythematosus (SLE)
Phase 3
Phase 3
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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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Ruxolitinib - TRuE-V
Vitiligo
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
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.
Ruxolitinib - REACH 3
Steroid-refractory chronic GVHD (Graft versus host disease)
Phase 3
Phase 3
Phase 3 trial met primary and secondary endpoints - July 23, 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. INDIANAPOLIS, Nov. 19, 2020 /PRNewswire/ -- Eli Lilly and Company (NYSE:LLY) and Incyte (NASDAQ:INCY) announced today 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 (ECMO).

    "Since the start of the COVID-19 pandemic, Lilly has been committed to finding potential treatments to help people around the world who've been impacted by this virus," said David A. Ricks, Lilly chairman and CEO…

    INDIANAPOLIS, Nov. 19, 2020 /PRNewswire/ -- Eli Lilly and Company (NYSE:LLY) and Incyte (NASDAQ:INCY) announced today 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 (ECMO).

    "Since the start of the COVID-19 pandemic, Lilly has been committed to finding potential treatments to help people around the world who've been impacted by this virus," said David A. Ricks, Lilly chairman and CEO. "Today's FDA action for baricitinib marks the second Lilly therapy to be granted an EUA, in addition to the recent neutralizing antibody EUA for high-risk non-hospitalized patients, increasing the number of treatment options for COVID-19 patients at different stages of the disease. This is an important milestone for hospitalized patients on oxygen, as baricitinib may help speed their recovery."

    The FDA grants emergency use authorization to provide availability of a medicine that may help diagnose, treat or prevent a life-threatening disease when no adequate and approved alternatives are available. This use of baricitinib is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use, unless the authorization is terminated or revoked sooner. The authorization is temporary and does not replace the formal review and approval process. In the U.S., baricitinib has not been approved by the FDA to treat COVID-19, and the efficacy, safety and optimal duration of treatment of baricitinib for COVID-19 has not been established. This is the first combination regimen authorized by FDA. Evaluation of baricitinib's efficacy and safety as a treatment for COVID-19 is ongoing in clinical trials.

    Scientific evidence supporting this EUA:

    The EUA is based on data from the Adaptive COVID-19 Treatment Trial (ACTT-2), a randomized double-blind, placebo-controlled study to evaluate the efficacy and safety of baricitinib in combination with remdesivir versus placebo with remdesivir in hospitalized patients with or without oxygen requirements conducted by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). All patients received standard supportive care by the trial site hospital. The recommended dose for this EUA is baricitinib 4-mg once daily for 14 days or until hospital discharge.

    Summary of Key Efficacy and Safety Findings

    • Patients treated with baricitinib in combination with remdesivir had a significant reduction in median time to recovery from 8 to 7 days (12.5% improvement) compared to remdesivir [hazard ratio: 1.15; 95% CI 1.00, 1.31; p=0.047].
    • Patients treated with baricitinib in combination with remdesivir were more likely to have a better clinical status at Day 15 compared to patients treated with remdesivir [odds ratio: 1.26; 95% CI 1.01, 1.57; p=0.044].
    • The proportion of patients who progressed to ventilation (non-invasive or invasive) or died by Day 29 was lower in baricitinib in combination with remdesivir (23%) compared to remdesivir (28%) [odds ratio: 0.74; 95% CI 0.56, 0.99; p=0.039].
    • The proportion of patients who died by Day 29 was 4.7% for baricitinib in combination with remdesivir vs. 7.1% for remdesivir, a relative reduction of 35% [Kaplan Meier estimated difference in Day 29 probability of mortality: -2.6% (95% CI -5.8%, 0.5%)].
    • Adverse events and serious adverse events were reported in 41% and 15% of patients treated with baricitinib in combination with remdesivir, respectively, vs. 48% and 20% in patients treated with remdesivir. Infections and venous thromboembolism (VTE) occurred in 6% and 4% of patients treated with baricitinib in combination with remdesivir, respectively, vs. 10% and 3% of patients treated with remdesivir. No new safety signals were identified for baricitinib-treated patients.

    "The results of ACTT-2 provide physicians and the medical community much-needed insights and randomized placebo-controlled evidence supporting the use of baricitinib in combination with remdesivir for the treatment of hospitalized patients with COVID-19; also importantly, the progression to ventilation or death was significantly reduced with the baricitinib-remdesivir combination," said Andre Kalil, M.D., professor at the University of Nebraska Medical Center and a principal investigator of the ACTT studies. "Few treatment options have received an EUA to treat COVID-19 so the authorization of baricitinib is an important step that will give healthcare providers another clinical tool to help patients with advanced disease."

    NIAID and the study investigators expect to have the full analysis published in a peer-reviewed manuscript soon.

    Baricitinib, an oral JAK inhibitor discovered by Incyte and licensed to Lilly, is approved and commercially available as OLUMIANT in the U.S. and more than 70 countries as a treatment for adults with moderate to severe rheumatoid arthritis (RA) and was recently approved in the European Union for the treatment of adult patients with moderate to severe atopic dermatitis who are candidates for systemic therapy. 

    "As a company, we have worked quickly and collaboratively to determine the potential utility of our medicines as treatments for COVID-19 and its related complications," said Hervé Hoppenot, Incyte CEO. "We are pleased that the FDA has authorized the use of baricitinib in combination with remdesivir for COVID-19, and look forward to the opportunity to make more therapies available to patients around the world affected by the global pandemic."     

    Access to baricitinib

    Under the EUA, inpatient pharmacies in the U.S. may order OLUMIANT (baricitinib) 1-mg and 2-mg tablets through Lilly authorized specialty distributors. A current list of Lilly's authorized distributors of record for the EUA is available at lillytrade.com. More details about these efforts are available here or by contacting Lilly's 24-hour support line at 1-855-LillyC19 (1-855-545-5921).

    Lilly is working with hospitals, healthcare professionals and governments to facilitate patient access to baricitinib and continues to explore the medicine's potential use in COVID-19 with other regulatory agencies outside the U.S. With respect to supply, Lilly remains confident in being able to meet the needs of patients under the EUA in the U.S., as well as for existing approved indications around the world.  

    Important information about baricitinib for COVID-19

    This EUA permits the emergency use of baricitinib, in combination with remdesivir, for treatment of suspected or laboratory confirmed COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or ECMO. Although there is limited safety data, no new safety issues have been identified. Physicians should avoid the use of baricitinib in patients with known active tuberculosis and consider if the potential benefits outweigh the potential risks in patients with active serious infections other than COVID-19 or chronic/recurrent infections. Prophylaxis for VTE is recommended unless contraindicated. If clinical features of deep vein thrombosis/pulmonary embolism occur, patients should be evaluated promptly and treated appropriately. Evaluate renal, hematologic and hepatic laboratory values at baseline and thereafter, and monitor closely when treating patients with abnormal baseline and post-baseline laboratory values. Avoid use of live vaccines with baricitinib. If a serious hypersensitivity occurs, discontinue baricitinib while evaluating the potential causes of the reaction. Serious venous thrombosis, including pulmonary embolism, and serious infections have been observed in COVID-19 patients treated with baricitinib.

    For more information about the authorized use of baricitinib in COVID-19 and mandatory requirements of the EUA, please see the FDA Letter of Authorization, Fact Sheet for Healthcare Providers and Fact Sheet for Patients, Parents and Caregivers (English) (Spanish). For media resources, including product images and fact sheets, please click here.

    There are other ongoing trials with baricitinib in COVID-19 hospitalized patients. In June 2020, Lilly initiated a Phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of baricitinib versus background therapy in hospitalized adults with COVID-19. The study includes a diverse patient population from Latin America, the U.S., Europe and Asia. Further information about this Phase 3 trial and other investigator-initiated trials can be accessed here or www.lillytrialguide.com.

    Indication and Usage for OLUMIANT (baricitinib) tablets (in the United States) for RA patients

    OLUMIANT® (baricitinib) 2-mg is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies. Limitation of Use: Not recommended for use in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine.

    IMPORTANT SAFETY INFORMATION FOR OLUMIANT (baricitinib) TABLETS 

    WARNING: SERIOUS INFECTIONS, MALIGNANCY, AND THROMBOSIS

    SERIOUS INFECTIONS: Patients treated with Olumiant are at risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt Olumiant until the infection is controlled. Reported infections include:

    • Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease. Test patients for latent TB before initiating Olumiant and during therapy. If positive, start treatment for latent infection prior to Olumiant use.
    • Invasive fungal infections, including candidiasis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.
    • Bacterial, viral, and other infections due to opportunistic pathogens.

    Carefully consider the risks and benefits of Olumiant prior to initiating therapy in patients with chronic or recurrent infection.

    Closely monitor patients for the development of signs and symptoms of infection during and after treatment with Olumiant including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

    MALIGNANCIES: Lymphoma and other malignancies have been observed in patients treated with Olumiant.

    THROMBOSIS: Thrombosis, including deep venous thrombosis (DVT) and pulmonary embolism (PE), has been observed at an increased incidence in patients treated with Olumiant compared to placebo. In addition, there were cases of arterial thrombosis. Many of these adverse events were serious and some resulted in death. Patients with symptoms of thrombosis should be promptly evaluated.

    WARNINGS AND PRECAUTIONS

    SERIOUS INFECTIONS: The most common serious infections reported with Olumiant included pneumonia, herpes zoster and urinary tract infection. Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, esophageal candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis, cytomegalovirus and BK virus were reported with Olumiant. Some patients have presented with disseminated rather than local disease and were often taking concomitant immunosuppressants such as methotrexate or corticosteroids. Avoid Olumiant in patients with an active, serious infection, including localized infections. Consider the risks and benefits of treatment prior to initiating Olumiant in patients:

    • with chronic or recurrent infection
    • who have been exposed to TB
    • with a history of a serious or an opportunistic infection
    • who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or
    • with underlying conditions that may predispose them to infection.

    Closely monitor patients for infections during and after Olumiant treatment. Interrupt Olumiant if a patient develops a serious infection, an opportunistic infection, or sepsis. Do not resume Olumiant until the infection is controlled.

    Tuberculosis Before initiating Olumiant evaluate and test patients for latent or active infection and treat patients with latent TB with standard antimycobacterial therapy. Olumiant should not be given to patients with active TB. Consider anti-TB therapy prior to initiating Olumiant in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent TB but who have risk factors for TB infection. Monitor patients for TB during Olumiant treatment.

    Viral Reactivation – Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical studies with Olumiant. If a patient develops herpes zoster, interrupt Olumiant treatment until the episode resolves.

    The impact of Olumiant on chronic viral hepatitis reactivation is unknown. Screen for viral hepatitis in accordance with clinical guidelines before initiating Olumiant.

    MALIGNANCY AND LYMPHOPROLIFERATIVE DISORDERS: Malignancies were observed in Olumiant clinical studies. Consider the risks and benefits of Olumiant prior to initiating therapy in patients with a known malignancy other than a successfully treated non-melanoma skin cancer (NMSC) or when considering continuing Olumiant in patients who develop a malignancy. NMSCs were reported in patients treated with Olumiant. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.

    THROMBOSIS:  Thrombosis, including DVT and PE, has been observed at an increased incidence in Olumiant-treated patients compared to placebo. In addition, arterial thrombosis events in the extremities have been reported in clinical studies with Olumiant. Many of these adverse events were serious and some resulted in death. There was no clear relationship between platelet count elevations and thrombotic events. Use Olumiant with caution in patients who may be at increased risk of thrombosis. If clinical features of DVT/PE or arterial thrombosis occur, evaluate patients promptly and treat appropriately.

    GASTROINTESTINAL PERFORATIONS: Gastrointestinal perforations have been reported in Olumiant clinical studies, although the role of JAK inhibition in these events is not known. Use Olumiant with caution in patients who may be at increased risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis). Promptly evaluate patients who present with new onset abdominal symptoms for early identification of gastrointestinal perforation.

    LABORATORY ABNORMALITIES:

    Neutropenia – Olumiant treatment was associated with an increased incidence of neutropenia (absolute neutrophil count [ANC] <1000 cells/mm3) compared to placebo. Avoid initiation or interrupt Olumiant treatment in patients with an ANC <1000 cells/mm3. Evaluate at baseline and thereafter according to routine patient management.

    Lymphopenia – Absolute lymphocyte count (ALC) <500 cells/mm3 were reported in Olumiant clinical trials. Lymphocyte counts less than the lower limit of normal were associated with infection in patients treated with Olumiant, but not placebo. Avoid initiation or interrupt Olumiant treatment in patients with an ALC <500 cells/mm3. Evaluate at baseline and thereafter according to routine patient management.

    Anemia – Decreases in hemoglobin levels to <8 g/dL were reported in Olumiant clinical trials. Avoid initiation or interrupt Olumiant treatment in patients with hemoglobin <8 g/dL. Evaluate at baseline and thereafter according to routine patient management.

    Liver Enzyme Elevations – Olumiant treatment was associated with increased incidence of liver enzyme elevation compared to placebo. Increases of ALT ≥5x upper limit of normal (ULN) and increases of AST ≥10x ULN were observed in patients in Olumiant clinical trials.

    Evaluate at baseline and thereafter according to routine patient management. Promptly investigate the cause of liver enzyme elevation to identify potential cases of drug-induced liver injury. If increases in ALT or AST are observed and drug-induced liver injury is suspected, interrupt Olumiant until this diagnosis is excluded.

    Lipid Elevations – Treatment with Olumiant was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol and high-density lipoprotein cholesterol. Assess lipid parameters approximately 12 weeks following Olumiant initiation. Manage patients according to clinical guidelines for the management of hyperlipidemia.

    VACCINATIONSAvoid use of live vaccines with Olumiant. Update immunizations in agreement with current immunization guidelines prior to initiating Olumiant therapy.

    HYPERSENSITIVITY: Reactions such as angioedema, urticaria, and rash that may reflect drug sensitivity have been observed in patients receiving Olumiant, including serious reactions. If a serious hypersensitivity reaction occurs, promptly discontinue Olumiant while evaluating the potential causes of the reaction.

    ADVERSE REACTIONS

    Most common adverse reactions include: upper respiratory tract infections (16.3%, 11.7%), nausea (2.7%, 1.6%), herpes simplex (0.8%, 0.7%) and herpes zoster (1.0%, 0.4%) for Olumiant 2 mg and placebo, respectively.

    USE IN SPECIFIC POPULATIONS

    PREGNANCY AND LACTATION: No information is available to support the use of Olumiant in pregnancy or lactation. Advise women not to breastfeed during treatment with Olumiant.

    HEPATIC AND RENAL IMPAIRMENT: Olumiant is not recommended in patients with severe hepatic impairment or in patients with severe renal impairment.

    Please click to access full Prescribing Information, including Boxed Warning about Serious Infections, Malignancies, and Thrombosis, and Medication Guide.

    BA HCP ISI 09JUL2020

    About Lilly's COVID-19 Efforts

    Lilly is bringing the full force of its scientific and medical expertise to attack the coronavirus pandemic around the world. Existing Lilly medicines are now being studied to understand their potential in treating complications of COVID-19, and the company is collaborating with two partner companies to discover novel antibody treatments for COVID-19. Lilly is testing both single antibody therapy as well as combinations of antibodies as potential therapeutics for COVID-19. Click here for resources related to Lilly's COVID-19 efforts.

    About OLUMIANT®

    OLUMIANT is a once-daily, oral JAK inhibitor approved in the U.S. for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more TNF inhibitor therapies, and approved outside of the U.S. for patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more DMARDs.1 Olumiant is also approved in the European Union for the treatment of adult patients with moderate to severe atopic dermatitis who are candidates for systemic therapy. There are four known JAK enzymes: JAK1, JAK2, JAK3 and TYK2. JAK-dependent cytokines have been implicated in the pathogenesis of a number of inflammatory and autoimmune diseases.2 OLUMIANT has greater inhibitory potency at JAK1, JAK2 and TYK2 relative to JAK3; however, the relevance of inhibition of specific JAK enzymes to therapeutic effectiveness is not currently known.1

    In December 2009, Lilly and Incyte announced an exclusive worldwide license and collaboration agreement for the development and commercialization of baricitinib and certain follow-on compounds for patients with inflammatory and autoimmune diseases.

    About Eli Lilly and Company 

    Lilly is a global health care leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at lilly.com and lilly.com/newsroom

    P-LLY

    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.  

    This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about OLUMIANT (baricitinib) as a potential treatment for patients with COVID-19 and as a treatment for patients with rheumatoid arthritis, and about the supply of OLUMIANT, and reflects Lilly's and Incyte's current beliefs. This press release also contains forward-looking statements about Lilly's neutralizing antibodies as potential treatments for patients with or at risk of infection from COVID-19 and reflects Lilly current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that OLUMIANT or Lilly's neutralizing antibody treatments will prove to be safe and effective treatments for patients with COVID-19, that OLUMIANT or Lilly's neutralizing antibody treatments will receive additional regulatory approvals or authorizations, that OLUMIANT will continue to be commercially successful, or that we can provide an adequate supply of OLUMIANT or Lilly's neutralizing antibody treatments in all circumstances. For further discussion of these and other risks and uncertainties, see Lilly's and Incyte's most recent respective Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly and Incyte undertake no duty to update forward-looking statements to reflect events after the date of this release.

    PP-BC-US-0007 11/2020 ©Lilly USA, LLC 2020. All rights reserved.

    1 Olumiant Prescribing Information, 2020.

    2 Walker JG and Smith MD. J Rheumatol. 2005;32;1650-1653.

    Refer to:

    Kristen Basu; ; +1-317-447-2199 (Lilly media)



    Kevin Hern; ; +1-317-277-1838 (Lilly investors)



    Catalina Loveman; ; +1-302-498-6171 (Incyte media)



    Michael Booth, DPhil; ; +1-302-498-5914 (Incyte investors)

     

    Eli Lilly and Company logo. (PRNewsFoto, Eli Lilly and Company) (PRNewsfoto/Eli Lilly and Company)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/baricitinib-receives-emergency-use-authorization-from-the-fda-for-the-treatment-of-hospitalized-patients-with-covid-19-301177712.html

    SOURCE Eli Lilly and Company

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  2. Incyte (NASDAQ:INCY) announced today that it will present at the 3rd Annual Evercore ISI Virtual HealthCONx Conference on Tuesday, December 1, 2020 at 10:30 a.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 3rd Annual Evercore ISI Virtual HealthCONx Conference on Tuesday, December 1, 2020 at 10:30 a.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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  3. Xencor (NASDAQ:XNCR), MorphoSys AG ((FSE: MOR, Prime Standard Segment, MDAX &amp, TecDAX, NASDAQ:MOR) and Incyte (NASDAQ:INCY) today announced a clinical collaboration to investigate the combination of tafasitamab, plamotamab and lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), first-line DLBCL, and relapsed or refractory follicular lymphoma (FL).

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201111005844/en/

    ‟Xencor is pleased to partner with MorphoSys and Incyte to advance the development of plamotamab, our CD20 x CD3 XmAb® bispecific antibody that has demonstrated encouraging clinical activity as a monotherapy in non-Hodgkin lymphoma…

    Xencor (NASDAQ:XNCR), MorphoSys AG ((FSE: MOR, Prime Standard Segment, MDAX &, TecDAX, NASDAQ:MOR) and Incyte (NASDAQ:INCY) today announced a clinical collaboration to investigate the combination of tafasitamab, plamotamab and lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), first-line DLBCL, and relapsed or refractory follicular lymphoma (FL).

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201111005844/en/

    ‟Xencor is pleased to partner with MorphoSys and Incyte to advance the development of plamotamab, our CD20 x CD3 XmAb® bispecific antibody that has demonstrated encouraging clinical activity as a monotherapy in non-Hodgkin lymphoma," said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. "Plamotamab, which redirects T cells to tumors, and tafasitamab, a CD19-directed XmAb antibody, combine powerful and distinct immune pathways, and this collaboration is designed to enable us to generate new clinical insights and accelerate development timelines for patients who may need additional therapeutic options. It builds upon many years of partnership between Xencor and MorphoSys following MorphoSys' in-licensing of tafasitamab in 2010."

    ‟Tafasitamab in combination with lenalidomide is an important new relapsed/refractory DLBCL treatment option for appropriate patients in the United States today, and its mechanism of action, efficacy and safety profile make it an attractive combination partner," said Jean-Paul Kress, M.D., chief executive officer of MorphoSys. "We believe that tafasitamab as a backbone can add value to new combinations such as with CD20 x CD3 bispecifics, and we are excited about this collaboration with Xencor and Incyte aiming to help more patients in areas of unmet need."

    ‟This collaboration has the potential to advance patient care and Incyte is proud to join Xencor and MorphoSys in evaluating this new combination approach for these serious cancers," said Hervé Hoppenot, chief executive officer of Incyte.

    Xencor's plamotamab is a tumor-targeted bispecific antibody that contains both a CD20 binding domain and a cytotoxic T-cell binding domain (CD3). Tafasitamab is MorphoSys' CD19-directed antibody which was recently approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory 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).

    Under the terms of the agreement, the companies plan to initiate a Phase 1/2 study evaluating the combination of tafasitamab, plamotamab and lenalidomide in patients with relapsed or refractory DLBCL. Additionally, the companies are planning to evaluate the combination in relapsed or refractory FL and first-line DLBCL in multiple Phase 1b studies. MorphoSys and Incyte will provide tafasitamab for the studies, which will be sponsored and funded by Xencor and are planned to be conducted in North America, Europe and Asia-Pacific.

    The collaboration is effective immediately upon the execution of the agreement.

    About Plamotamab (XmAb®13676)

    Plamotamab (XmAb®13676) is a tumor-targeted bispecific antibody that contains both a CD20 binding domain and a cytotoxic T-cell binding domain (CD3), which is currently in a Phase 1 clinical study for the treatment of non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL). An XmAb Bispecific Fc domain serves as the scaffold for these two antigen binding domains and confers long circulating half-life, stability and ease of manufacture on plamotamab. CD20 is highly expressed on B-cell tumors, including NHL and CLL. Engagement of CD3 by plamotamab activates T cells for highly potent and targeted killing of CD20-expressing tumor cells.

    About Tafasitamab

    Tafasitamab 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® (tafasitamab-cxix) 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 Xencor

    Xencor is a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of cancer and autoimmune diseases. Currently, 18 candidates engineered with Xencor's XmAb® technology are in clinical development internally and with partners. Xencor's XmAb antibody engineering technology enables small changes to the structure of monoclonal antibodies resulting in new mechanisms of therapeutic action. For more information, please visit www.xencor.com.

    About MorphoSys

    MorphoSys ((FSE &, NASDAQ:MOR) is a commercial-stage biopharmaceutical company dedicated to the discovery, development and commercialization of exceptional, innovative therapies for patients suffering from serious diseases. The focus is on cancer. Based on its leading expertise in antibody, protein and peptide technologies, MorphoSys, together with its partners, has developed and contributed to the development of more than 100 product candidates, of which 27 are currently in clinical development. In 2017, Tremfya®, developed by Janssen Research & Development, LLC and marketed by Janssen Biotech, Inc., for the treatment of plaque psoriasis, became the first drug based on MorphoSys' antibody technology to receive regulatory approval. In July 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval of MorphoSys' proprietary product Monjuvi® (tafasitamab-cxix) in combination with lenalidomide in patients with a certain type of lymphoma.

    Headquartered near Munich, Germany, the MorphoSys group, including the fully owned U.S. subsidiary MorphoSys US Inc., has ~500 employees. More information at www.morphosys.com or www.morphosys-us.com.

    Monjuvi® is a registered trademark of MorphoSys AG.

    Tremfya® is a registered trademark of Janssen Biotech, Inc.

    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.

    Xencor Forward-looking Statements

    Statements contained in this press release regarding matters that are not historical facts are forward-looking statements within the meaning of applicable securities laws, including, but not limited to, the quotations from Xencor's president and chief executive officer; the outcome of the collaboration with MorphoSys and Incyte, including the ability of the collaboration to generate new clinical insights, accelerate development timelines and advance patient care; the ability of the proposed combination treatment to improve response rates and address more patients in areas of unmet need; and the timing and success of the Phase 1/2 study and multiple Phase 1b studies contemplated by the agreement. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements and the timing of events to be materially different from those implied by such statements, and therefore these statements should not be read as guarantees of future performance or results. Such risks include, without limitation, the risks associated with the process of discovering, developing, manufacturing and commercializing drugs that are safe and effective for use as human therapeutics and other risks described in Xencor's public securities filings. For a discussion of these and other factors, please refer to Xencor's annual report on Form 10-K for the year ended December 31, 2019 as well as Xencor's subsequent filings with the Securities and Exchange Commission. All forward-looking statements are based on Xencor's current information and belief as well as assumptions made by Xencor. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This cautionary statement is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and Xencor undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

    MorphoSys Forward-Looking Statements

    This communication contains certain forward-looking statements concerning the MorphoSys group of companies, including the expectations regarding Monjuvi's ability to treat patients with relapsed or refractory diffuse large B-cell lymphoma, the further clinical development of tafasitamab-cxix, including ongoing confirmatory trials, additional interactions with regulatory authorities and expectations regarding future regulatory filings and possible additional approvals for tafasitamab-cxix as well as the commercial performance of Monjuvi. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "would," "could," "potential," "possible," "hope" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The forward-looking statements contained herein represent the judgment of MorphoSys as of the date of this release and involve known and unknown risks and uncertainties, which might cause the actual results, financial condition and liquidity, performance or achievements of MorphoSys, or industry results, to be materially different from any historic or future results, financial conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements. In addition, even if MorphoSys' results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Among the factors that may result in differences are MorphoSys' expectations regarding risks and uncertainties related to the impact of the COVID-19 pandemic to MorphoSys' business, operations, strategy, goals and anticipated milestones, including its ongoing and planned research activities, ability to conduct ongoing and planned clinical trials, clinical supply of current or future drug candidates, commercial supply of current or future approved products, and launching, marketing and selling current or future approved products, the global collaboration and license agreement for tafasitamab, the further clinical development of tafasitamab, including ongoing confirmatory trials, and MorphoSys' ability to obtain and maintain requisite regulatory approvals and to enroll patients in its planned clinical trials, additional interactions with regulatory authorities and expectations regarding future regulatory filings and possible additional approvals for tafasitamab-cxix as well as the commercial performance of Monjuvi, MorphoSys' reliance on collaborations with third parties, estimating the commercial potential of its development programs and other risks indicated in the risk factors included in MorphoSys' Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. MorphoSys expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation.

    Incyte Forward-looking Statements

    Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding expectations regarding Monjuvi's ability to treat patients with relapsed or refractory diffuse large B-cell lymphoma, the further clinical development of tafasitamab-cxix, including ongoing confirmatory trials, additional interactions with regulatory authorities and expectations regarding future regulatory filings and possible additional approvals for tafasitamab-cxix as well as the commercial performance of Monjuvi, and the development of tafasitamab-cxix in combination with plamotamab, contain predictions, estimates and other forward-looking statements. These forward-looking statements are based on the 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: 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 regulatory authorities; the efficacy or safety of Incyte's or its collaborators' products; the acceptance of Incyte's products and the products of its 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-Q for the quarter ended September 30, 2020. Incyte disclaims any intent or obligation to update these forward-looking statements.

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  4. Incyte (NASDAQ:INCY) today announced that abstracts highlighting data from its oncology portfolio will be presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting, held virtually from November 11-14, 2020.

    "We are excited to join the oncology community at the SITC 35th anniversary annual meeting and look forward to sharing data from our immuno-oncology portfolio," said Lance Leopold, Group Vice President, Immuno-Oncology, Incyte. "In particular, initial translational data from the ongoing clinical trial support further development of our orally administered PD-L1 inhibitor INCB86550 — a novel small-molecule discovered at Incyte."

    E-Poster Presentations:

    Pharmacodynamic Biomarkers Demonstrate T-Cell Activation in Patients

    Incyte (NASDAQ:INCY) today announced that abstracts highlighting data from its oncology portfolio will be presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting, held virtually from November 11-14, 2020.

    "We are excited to join the oncology community at the SITC 35th anniversary annual meeting and look forward to sharing data from our immuno-oncology portfolio," said Lance Leopold, Group Vice President, Immuno-Oncology, Incyte. "In particular, initial translational data from the ongoing clinical trial support further development of our orally administered PD-L1 inhibitor INCB86550 — a novel small-molecule discovered at Incyte."

    E-Poster Presentations:

    Pharmacodynamic Biomarkers Demonstrate T-Cell Activation in Patients Treated with the Oral PD-L1 Inhibitor INCB086550 in a Phase 1 Clinical Trial [Poster #419]

    Retrospective Pooled Analysis of Epacadostat Clinical Studies Identifies Doses Required for Maximal Pharmacodynamic Effect in Anti-PD-1 Combination Studies [Poster #28]

    MCLA-145 (CD137xPD-L1): A Potent CD137 Agonist and Immune Checkpoint Inhibitor That Does Not Show Signs of Peripheral Toxicity [Poster #814]1

    MCLA-145 is a Bispecific IgG1 Antibody that Inhibits PD-1/PD-L1 Signaling While Simultaneously Activating CD137 Signaling on T Cells [Poster #820]1

    A Phase 1 Study of Retifanlimab (INCMGA00012), a PD-1 Inhibitor, in Patients with Advanced Solid Tumors: Preliminary Results in Recurrent MSI-High or dMMR Endometrial Cancer (POD1UM-101) [Poster #268]

    A Phase 2 Umbrella Study of Retifanlimab (INCMGA00012) Alone or in Combination with Other Therapies in Patients with Advanced or Metastatic Endometrial Cancer (POD1UM-204, GOG 3038, ENGOT-en12/NOGGO) [Trial in Progress; Poster #348]2

    All posters will be on display from Monday, November 9, 2020 until the virtual poster hall closes on December 31, 2020.

    Abstracts are available on the SITC 2020 website at https://www.sitcancer.org/2020.

    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.

    1Merus-sponsored; 2In collaboration with the Gynecologic Oncology Group and the European Network for Gynecological Oncological Trial (ENGOT) groups.

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    • Total product and royalty revenues of $621 million (+16% vs Q3 2019) for the quarter ended September 30, 2020; Jakafi® (ruxolitinib) revenues of $488 million in Q3 2020 (+13% vs Q3 2019); Incyte tightens full year 2020 Jakafi revenue guidance to a range of $1.910 to $1.940 billion
    • Strong momentum behind commercial launches of both Monjuvi® (tafasitamab-cxix) and Pemazyre® (pemigatinib) in the U.S.
    • Incyte Dermatology established as a new franchise in the U.S.; priority review voucher acquired and expected to be used in NDA seeking approval for ruxolitinib cream in atopic dermatitis
    • Late-stage clinical development pipeline continues to progress with multiple pivotal trials in oncology and dermatology

    Conference Call and Webcast Scheduled…

    • Total product and royalty revenues of $621 million (+16% vs Q3 2019) for the quarter ended September 30, 2020; Jakafi® (ruxolitinib) revenues of $488 million in Q3 2020 (+13% vs Q3 2019); Incyte tightens full year 2020 Jakafi revenue guidance to a range of $1.910 to $1.940 billion
    • Strong momentum behind commercial launches of both Monjuvi® (tafasitamab-cxix) and Pemazyre® (pemigatinib) in the U.S.
    • Incyte Dermatology established as a new franchise in the U.S.; priority review voucher acquired and expected to be used in NDA seeking approval for ruxolitinib cream in atopic dermatitis
    • Late-stage clinical development pipeline continues to progress with multiple pivotal trials in oncology and dermatology

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

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

    "We are pleased to report another strong quarter for Incyte, with continued strength across all Jakafi® (ruxolitinib) indications, good momentum behind the U.S. launches of both Monjuvi® (tafasitamab-cxix) and Pemazyre® (pemigatinib), as well as increasing royalty contributions from our partnered medicines globally," stated Hervé Hoppenot, Chief Executive Officer, Incyte. "In addition, we have now established Incyte Dermatology as a new franchise for Incyte in the U.S., and we are on track to submit the NDA for ruxolitinib cream at the end of this year which, by using our priority review voucher, could lead to an FDA decision in the middle of next year."

    Portfolio Update

    LIMBER – key highlights

    Two pivotal trials are being initiated to evaluate the combination of ruxolitinib and parsaclisib as both first-line therapy for myelofibrosis (MF) patients and in MF patients with an inadequate response to ruxolitinib monotherapy.

    The Phase 2 monotherapy trial of INCB57643 (BET) in patients with refractory myelofibrosis are now recruiting and the Phase 2 monotherapy trial of INCB00928 (ALK2) in patients with myelofibrosis is being opened. Both programs are expected to proceed to ruxolitinib combination trials upon completion of monotherapy cohorts.

     

    Indication and status

    Once-a-day ruxolitinib

    (JAK1/JAK2)

    Myelofibrosis and polycythemia vera: clinical pharmacology studies

    ruxolitinib + parsaclisib

    (JAK1/JAK2 + PI3Kδ)

    Myelofibrosis: Phase 3 in preparation

    Myelofibrosis: Phase 3 in preparation (inadequate responders to ruxolitinib)

    ruxolitinib + INCB57643

    (JAK1/JAK2 + BET)

    Myelofibrosis: Phase 2 in preparation

    ruxolitinib + INCB00928

    (JAK1/JAK2 + ALK2)

    Myelofibrosis: Phase 2 in preparation

    Oncology beyond MPNs – key highlights

    In August, Monjuvi® (tafasitamab-cxix) in combination with lenalidomide was included in the latest National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for B-cell Lymphomas with a Category 2A designation as an option for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) and who are not eligible for autologous stem cell transplant (ASCT).

    The European Marketing Authorization Application (MAA) for tafasitamab as a treatment for patients with r/r DLBCL is under review. Incyte has exclusive development and commercialization rights to tafasitamab outside of the U.S.

    Incyte and MorphoSys plan to further broaden the development program of tafasitamab in other B-cell malignancies. Multiple trials are in preparation, including Phase 3 trials in both first line DLBCL and relapsed/refractory follicular lymphoma, as well as a proof-of-concept trial of tafasitamab plus parsaclisib (PI3Kδ).

    In September, initial results from the Phase 2 POD1UM-202 trial of retifanlimab in previously treated patients with advanced squamous cell anal carcinoma (SCAC) who have progressed following standard platinum-based chemotherapy were presented at the European Society for Medical Oncology (ESMO) annual meeting. The Phase 3 POD1UM-303 trial of retifanlimab in combination with platinum-based chemotherapy as a first-line treatment for patients with SCAC is open for recruitment.

    Given the rapidly evolving treatment landscape for bladder cancer and recent regulatory feedback, Incyte is reevaluating its development strategy for pemigatinib in bladder cancer. As part of that reevaluation, new patient recruitment into FIGHT-205, which is assessing pemigatinib in cisplatin-ineligible bladder cancer patients whose tumors express FGFR3 mutation or rearrangement, has been stopped, and Incyte no longer intends to use data from FIGHT-201 to seek accelerated approval for pemigatinib in patients with previously treated bladder cancer whose tumors express FGFR3 mutation or rearrangement.

     

    Indication and status

    ruxolitinib

    (JAK1/JAK2)

    Steroid-refractory chronic GVHD: Phase 3 (REACH3)1 primary endpoint met

    itacitinib

    (JAK1)

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

     

    pemigatinib

    (FGFR1/2/3)

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

    8p11 MPN: Phase 2 (FIGHT-203)

    Tumor agnostic: Phase 2 (FIGHT-207)

    tafasitamab

    (CD19)2

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

    1L DLBCL: Phase 1b (First-MIND); Phase 3 (Front-MIND) in preparation

    r/r follicular lymphoma: Phase 3 in preparation

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

    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

    MSI-high endometrial cancer: Phase 2 (POD1UM-101); Phase 2 (POD1UM-204) in preparation

    Merkel cell carcinoma: Phase 2 (POD1UM-201)

    SCAC: Phase 2 (POD1UM-202); Phase 3 (POD1UM-303) open for recruitment

    NSCLC: Phase 3 (POD1UM-304)

    CCA = cholangiocarcinoma; DLBCL = diffuse large B-cell lymphoma; SCAC = squamous cell anal carcinoma

    1)

     

    Clinical development of ruxolitinib in GVHD conducted in collaboration with Novartis

    2)

     

    Development of tafasitamab in collaboration with MorphoSys

    3)

     

    retifanlimab licensed from MacroGenics

    Inflammation and Autoimmunity (IAI) – key highlights

    Dermatology

    Incyte Dermatology has been established as a new franchise for Incyte in the U.S., which will include dedicated teams for the development and commercialization of Incyte's dermatology portfolio.

    The NDA for ruxolitinib cream in atopic dermatitis is on track for submission at the end of 2020. Incyte has acquired a priority review voucher, which it intends to use to accelerate the timeline to FDA decision.

    Pooled results from the TRuE-AD studies were presented at the European Academy of Dermatology and Venereology (EADV) Congress. Ruxolitinib cream demonstrated clinically meaningful improvements in patient-reported quality of life assessments, such as the PROMIS (patient-reported outcomes measurement information system) sleep disturbance (8b) score, as well as substantial and sustained itch reduction, reinforcing its potential as an important treatment option for atopic dermatitis patients.

    The two randomized Phase 3 trials in the TRuE-V pivotal program evaluating ruxolitinib cream in patients with vitiligo are fully recruited, with results expected in 2021.

    Other IAI

    Initial clinical results from INCB54707, a JAK1 selective inhibitor, were presented in October. INCB54707 demonstrated preliminary efficacy, improved quality of life (QoL) including a reduction in skin pain and a tolerable safety profile in patients with moderate-to-severe hidradenitis suppurativa (HS). A Phase 2b, randomized, double-blind, placebo-controlled trial evaluating INCB54707 in HS is ongoing.

     

    Indication and status

    ruxolitinib cream

    (JAK1/JAK2)

    Atopic dermatitis: Phase 3 (TRuE-AD1, TRuE-AD2; primary endpoints met)

    Vitiligo: Phase 3 (TRuE-V1, TRuE-V2)

    INCB54707

    (JAK1)

    Hidradenitis suppurativa: Phase 2b

     

    parsaclisib

    (PI3Kδ)

    Autoimmune hemolytic anemia: Phase 2

     

    INCB00928

    (ALK2)

    Fibrodysplasia ossificans progressiva: Phase 2 in preparation

    Discovery and early development – key highlights

    Incyte's portfolio of other earlier-stage clinical candidates is summarized below.

    Clinical translational data from the ongoing proof-of-concept trial of INCB86550, Incyte's first-in-class oral small molecule inhibitor of PD-L1, have been accepted for presentation at the 2020 Society for Immunotherapy for Cancer (SITC) meeting. As previously disclosed, initial clinical efficacy and safety data from this trial are expected to be presented in 2021, once these data mature.

     

    Modality

    Candidates

    Small molecules

    INCB01158 (ARG)1, INCB81776 (AXL/MER), epacadostat (IDO1), INCB86550 (PD-L1)

     

    Monoclonal antibodies2

    INCAGN1876 (GITR), INCAGN2385 (LAG-3), INCAGN1949 (OX40), INCAGN2390 (TIM-3)

    Bispecific antibodies

    MCLA-145 (PD-L1xCD137)3

     

    1)

    INCB01158 licensed from Calithera

    2)

    Discovery collaboration with Agenus

    3)

    MCLA-145 development in collaboration with Merus

    Potential therapies for patients with COVID-19

    Patient recruitment into the Phase 3 RUXCOVID study evaluating ruxolitinib versus standard-of-care in hospitalized patients with COVID-19 associated cytokine storm has been completed, and topline results are expected to be available before the end of 2020.

    In September, Incyte and Eli Lilly announced initial results from the baricitinib arm of the National Institute of Allergy and Infectious Diseases (NIAID) Adaptive COVID-19 Treatment Trial (ACTT-2), where baricitinib in combination with remdesivir reduced the time to recovery (primary endpoint) in comparison with remdesivir alone.

    Additional data announced in October showed that baricitinib plus remdesivir resulted in a numerical decrease in mortality through Day 29 compared to remdesivir alone, with a more pronounced reduction seen in more severely ill patients.

     

    Status

    ruxolitinib

    (JAK1/JAK2)

    COVID-19 associated cytokine storm: Phase 3 (RUXCOVID1; DEVENT)

     

    baricitinib

    (JAK1/JAK2)2

    Hospitalized patients with COVID-19: Phase 3 (ACTT-23; COV-BARRIER)

     

    1)

    Sponsored by Incyte in the United States and by Novartis outside of the United States

    2)

    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 for moderate to severe atopic dermatitis.

    3)

    ACTT-2 agreement with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health

    Partnered – key highlights

    In October, Lilly announced that the European Commission granted marketing authorization for Olumiant® (baricitinib) 4mg and 2mg tablets in Europe for the treatment of adults with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy, becoming the first JAK-inhibitor indicated to help treat patients with AD.

    In September, Incyte and Novartis announced that GEOMETRY mono-1 results of TabrectaTM (capmatinib) in patients with METex14 metastatic non-small cell lung cancer (NSCLC) were published in The New England Journal of Medicine.

     

     

    Indication and status

    baricitinib

    (JAK1/JAK2)1

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

    Systemic lupus erythematosus: Phase 3

    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

    2)

    Worldwide rights to capmatinib licensed to Novartis

    2020 Third Quarter Financial Results

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

     

    Nine Months Ended

    September 30,

     

    September 30,

     

    2020

     

     

     

    2019

     

     

    2020

     

     

     

    2019

    Total GAAP revenue

    $

    620,643

     

    $

    551,581

    $

    1,877,193

     

    $

    1,579,370

     

    Total GAAP operating income (loss)

     

    5,326

     

     

    134,316

     

    (427,905

    )

     

    306,998

    Total Non-GAAP operating income (loss)

     

    61,619

     

     

    186,338

     

    (259,347

    )

     

    464,274

    GAAP net income (loss)

     

    (15,203

    )

     

    128,271

     

    (445,547

    )

     

    335,901

    Non-GAAP net income (loss)

     

    50,059

     

     

    179,019

     

    (295,283

    )

     

    476,030

     

    GAAP basic EPS

    $

    (0.07

    )

    $

    0.60

    $

    (2.05

    )

    $

    1.57

    Non-GAAP basic EPS

    $

    0.23

     

    $

    0.83

    $

    (1.36

    )

    $

    2.22

    GAAP diluted EPS

    $

    (0.07

    )

    $

    0.59

    $

    (2.05

    )

    $

    1.55

    Non-GAAP diluted EPS

    $

    0.23

     

    $

    0.82

    $

    (1.36

    )

    $

    2.19

    Revenue Details

    Revenue Details

    (unaudited, in thousands)

     

    Three Months Ended

     

     

     

    Nine Months Ended

     

     

    September 30,

     

    %

     

    September 30,

     

    %

     

    2020

     

     

    2019

     

    Change

     

     

    2020

     

     

    2019

     

    Change

    Revenues:

    Jakafi net product revenue

    $

    487,783

    $

    433,387

    13

    %

    $

    1,420,968

    $

    1,218,504

    17

    %

    Iclusig net product revenue

     

    26,380

     

    20,611

    28

    %

     

    76,426

     

    65,640

    16

    %

    Pemazyre net product revenue

     

    8,089

     

    -

     

    11,875

     

    -

    Jakavi product royalty revenues

     

    68,306

     

    58,440

    17

    %

     

    190,856

     

    160,906

    19

    %

    Olumiant product royalty revenues

     

    28,647

     

    21,643

    32

    %

     

    79,924

     

    56,820

    41

    %

    Tabrecta product royalty revenues

     

    1,438

     

    -

     

    2,144

     

    -

    Product and royalty revenues

     

    620,643

     

    534,081

    16

    %

     

    1,782,193

     

    1,501,870

    19

    %

    Milestone and contract revenues

     

    -

     

    17,500

    (100

    %)

     

    95,000

     

    77,500

    23

    %

    Total GAAP revenues

    $

    620,643

    $

    551,581

    13

    %

    $

    1,877,193

    $

    1,579,370

    19

    %

    Product and Royalty Revenues Product and royalty revenues for the three and nine months ended September 30, 2020 increased 16% and 19%, 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 three and nine months ended September 30, 2020 increased 13% and 17%, 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

     

     

     

    Nine Months Ended

     

     

    September 30,

     

    %

     

    September 30,

     

    %

     

    2020

     

     

    2019

     

    Change

     

     

    2020

     

     

    2019

     

    Change

    GAAP cost of product revenues

    $

    34,322

    $

    30,040

    14

    %

    $

    95,005

    $

    82,034

    16

    %

    Non-GAAP cost of product revenues1

     

    28,693

     

    24,483

    17

    %

     

    78,137

     

    65,357

    20

    %

     

    GAAP research and development

     

    438,109

     

    281,336

    56

    %

     

    1,809,997

     

    841,244

    115

    %

    Non-GAAP research and development2

     

    409,134

     

    250,910

    63

    %

     

    1,719,816

     

    755,780

    128

    %

     

    GAAP selling, general and administrative

     

    120,788

     

    102,608

    18

    %

     

    349,934

     

    332,534

    5

    %

    Non-GAAP selling, general and administrative3

     

    106,208

     

    89,850

    18

    %

     

    308,215

     

    293,959

    5

    %

     

    GAAP change in fair value of acquisition-related contingent consideration

     

    7,109

     

    3,281

    117

    %

     

    19,790

     

    16,560

    20

    %

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

     

    -

     

    -

     

    -

     

    -

     

    GAAP collaboration loss sharing

     

    14,989

     

    -

     

    30,372

     

    -

    Non-GAAP collaboration loss sharing

     

    14,989

     

    -

     

    30,372

     

    -

    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 three months ended September 30, 2020 increased 56% and 63%, respectively, compared to the same period in 2019, primarily due to $120 million of expense related to the purchase of an FDA priority review voucher from a third party, which we intend to use to accelerate the FDA review of ruxolitinib cream for the treatment of atopic dermatitis and an increase in milestone expenses related to our collaborative agreements. For the nine months ended September 30, 2020, GAAP and Non-GAAP research and development expense increased 115% and 128%, respectively, compared to the same period in 2019, primarily due to upfront consideration of $805 million related to our collaborative agreement with MorphoSys and expense related to the purchase of the FDA priority review voucher.

    Selling, general and administrative expenses GAAP and Non-GAAP selling, general and administrative expenses for the three months and nine months ended September 30, 2020 increased 18% and 5%, respectively, compared to the same periods in 2019, primarily due to increased headcount and activities supporting the commercialization of our products and the timing of certain expenses.

    Other Financial Information

    Operating income (loss) GAAP and Non-GAAP operating income for the three months ended September 30, 2020 decreased compared to the same period in 2019, primarily due to $120 million of expense related to the purchase of the FDA priority review voucher and milestone expenses related to our collaborative agreements. For the nine months ended September 30, 2020 we 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 FDA priority review voucher, partially offset by the growth in product and royalty revenues.

    Cash, cash equivalents and marketable securities position As of September 30, 2020 and December 31, 2019, cash, cash equivalents and marketable securities totaled $1.7 billion and $2.1 billion, respectively. The decrease is primarily driven by the upfront payment and stock purchase related to our collaborative agreement with MorphoSys and purchase of the FDA priority review voucher and is partially offset by the cash flow generated during this nine-month period.

    2020 Financial Guidance

    Incyte has tightened its full year 2020 guidance for Jakafi net product revenues, as detailed below. The company's full year 2020 financial guidance is summarized in the following table. The R&D expense guidance excludes $805 million of upfront consideration paid under the MorphoSys collaboration and $120 million of expense related to the purchase of the FDA priority review voucher (PRV). The financial guidance also excludes the impact of any potential future strategic transactions.

     

    All data in millions1

     

    Current

     

    Previous

    Jakafi net product revenues

     

    $1,910 - $1,940

     

    $1,880 - $1,950

    Iclusig net product revenues

     

    $100 - $105

     

    Unchanged

    Cost of product revenues

     

    $130 - $135

     

    Unchanged

    Research and development expenses (Excl. MOR upfront cons. & PRV)

     

    $1,210 - $1,280

     

    Unchanged

    Selling, general and administrative expenses

     

    $505 - $535

     

    Unchanged

    Change in fair value of acquisition-related contingent consideration

     

    $25 - $27

     

    Unchanged

    1. Amounts exclude Non-GAAP adjustments (e.g., stock based comp, amortization of acquired product rights for Iclusig and change in fair value of estimated future royalties for Iclusig). Research and development expenses also excludes $805 million of upfront consideration paid under the MorphoSys collaboration and $120 million of expense related to the purchase of the FDA priority review voucher.

    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, 13711777.

    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, 13711777.

    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).

    In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize Monjuvi globally. Monjuvi will be 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 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.

    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, Incyte's marketing authorization application (MAA) seeking the approval of pemigatinib for patients with cholangiocarcinoma in the EU has been validated by the European Medicines Agency (EMA) and is currently under review for the treatment of adults with 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: the expected use of the priority review voucher and its effect on the timing of the FDA review process, the expected timing for the submission of the an NDA for ruxolitinib cream for atopic dermatitis and the expected timing of any FDA decision with respect to such NDA; plans for ruxolitinib combination trials with INCB57643 (BET) and INCB00928 (ALK2); plans to further broaden the development program of tafasitamab in other B-cell malignancies and clinical trial plans for such program; the expected timing of receipt of clinical trial results for ruxolitinib cream for vitiligo and ruxolitinib for COVID-19; the expected timing of receipt and announcement of clinical trial results for INCB86550; and the Company's reaffirmed and updated financial guidance for 2020 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: unanticipated delays in the submission of the Company's NDA for ruxolitinib cream for atopic dermatitis; the actual time required by the FDA to review the Company's NDA for approval for ruxolitinib cream in atopic dermatitis, should such NDA be submitted, and the results of such review; 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 June 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

     

    Nine Months Ended

    September 30,

     

    September 30,

     

    2020

     

     

     

    2019

     

     

     

    2020

     

     

     

    2019

     

    GAAP

     

    GAAP

    Revenues:

    Product revenues, net

    $

    522,252

     

    $

    453,998

     

    $

    1,509,269

     

    $

    1,284,144

     

    Product royalty revenues

     

    98,391

     

     

    80,083

     

     

    272,924

     

     

    217,726

     

    Milestone and contract revenues

     

    -

     

     

    17,500

     

     

    95,000

     

     

    77,500

     

    Total revenues

     

    620,643

     

     

    551,581

     

     

    1,877,193

     

     

    1,579,370

     

     

    Costs and expenses:

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

     

    34,322

     

     

    30,040

     

     

    95,005

     

     

    82,034

     

    Research and development

     

    438,109

     

     

    281,336

     

     

    1,809,997

     

     

    841,244

     

    Selling, general and administrative

     

    120,788

     

     

    102,608

     

     

    349,934

     

     

    332,534

     

    Change in fair value of acquisition-related contingent consideration

     

    7,109

     

     

    3,281

     

     

    19,790

     

     

    16,560

     

    Collaboration loss sharing

     

    14,989

     

     

    -

     

     

    30,372

     

     

    -

     

    Total costs and expenses

     

    615,317

     

     

    417,265

     

     

    2,305,098

     

     

    1,272,372

     

     

    Income (loss) from operations

     

    5,326

     

     

    134,316

     

     

    (427,905

    )

     

    306,998

     

    Other income (expense), net

     

    4,917

     

     

    11,961

     

     

    18,396

     

     

    36,334

     

    Interest expense

     

    (544

    )

     

    (597

    )

     

    (1,746

    )

     

    (1,248

    )

    Unrealized gain (loss) on long term investments

     

    (13,207

    )

     

    2,339

     

     

    10,935

     

     

    18,703

     

    Income (loss) before provision for income taxes

     

    (3,508

    )

     

    148,019

     

     

    (400,320

    )

     

    360,787

     

    Provision for income taxes

     

    11,695

     

     

    19,748

     

     

    45,227

     

     

    24,886

     

    Net income (loss)

    $

    (15,203

    )

    $

    128,271

     

    $

    (445,547

    )

    $

    335,901

     

     

    Net income (loss) per share:

    Basic

    $

    (0.07

    )

    $

    0.60

     

    $

    (2.05

    )

    $

    1.57

     

    Diluted

    $

    (0.07

    )

    $

    0.59

     

    $

    (2.05

    )

    $

    1.55

     

     

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

    Basic

     

    218,784

     

     

    215,199

     

     

    217,684

     

     

    214,628

     

    Diluted

     

    218,784

     

     

    217,791

     

     

    217,684

     

     

    217,393

     

    INCYTE CORPORATION

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (unaudited, in thousands)

     

    September 30,

    December 31,

     

    2020

     

    2019

    ASSETS

    Cash, cash equivalents and marketable securities

    $

    1,734,800

    $

    2,117,554

    Accounts receivable

     

    356,182

     

    308,809

    Property and equipment, net

     

    498,335

     

    377,567

    Finance lease right-of-use assets, net

     

    29,123

     

    29,058

    Inventory

     

    25,709

     

    16,505

    Prepaid expenses and other assets

     

    107,203

     

    94,179

    Long term investments

     

    222,810

     

    133,657

    Other intangible assets, net

     

    177,675

     

    193,828

    Goodwill

     

    155,593

     

    155,593

    Total assets

    $

    3,307,430

    $

    3,426,750

     

    LIABILITIES AND STOCKHOLDERS' EQUITY

    Accounts payable, accrued expenses and other liabilities

    $

    597,871

    $

    500,462

    Finance lease liabilities

     

    34,826

     

    32,582

    Convertible senior notes

     

    11,900

     

    18,300

    Acquisition-related contingent consideration

     

    272,000

     

    277,000

    Stockholders' equity

     

    2,390,833

     

    2,598,406

    Total liabilities and stockholders' equity

    $

    3,307,430

    $

    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

     

    Nine Months Ended

    September 30,

     

    September 30,

     

    2020

     

     

     

    2019

     

     

     

    2020

     

     

     

    2019

     

     

    GAAP Net Income (Loss)

    $

    (15,203

    )

    $

    128,271

     

    $

    (445,547

    )

    $

    335,901

     

    Adjustments1:

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

     

    28,975

     

     

    30,426

     

     

    90,181

     

     

    85,464

     

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

     

    14,580

     

     

    12,758

     

     

    41,719

     

     

    38,575

     

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

     

    245

     

     

    173

     

     

    716

     

     

    525

     

    Non-cash interest expense related to convertible notes3

     

    168

     

     

    218

     

     

    617

     

     

    646

     

    Changes in fair value of equity investments4

     

    13,207

     

     

    (2,339

    )

     

    (10,935

    )

     

    (18,703

    )

    Amortization of acquired product rights5

     

    5,384

     

     

    5,384

     

     

    16,152

     

     

    16,152

     

    Change in fair value of contingent consideration6

     

    7,109

     

     

    3,281

     

     

    19,790

     

     

    16,560

     

    Tax effect of Non-GAAP adjustments7

     

    (4,406

    )

     

    847

     

     

    (7,976

    )

     

    910

     

    Non-GAAP Net Income (Loss)

    $

    50,059

     

    $

    179,019

     

    $

    (295,283

    )

    $

    476,030

     

     

    Non-GAAP net income (loss) per share:

    Basic

    $

    0.23

     

    $

    0.83

     

    $

    (1.36

    )

    $

    2.22

     

    Diluted

    $

    0.23

     

    $

    0.82

     

    $

    (1.36

    )

    $

    2.19

     

     

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

    Basic

     

    218,784

     

     

    215,199

     

     

    217,684

     

     

    214,628

     

    Diluted

     

    221,357

     

     

    217,791

     

     

    217,684

     

     

    217,393

     

    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, 2020 are milestones of $0 and $95,000, respectively, earned from our collaborative partners as compared to upfront consideration and milestones of $17,500 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 nine months ended September 30, 2020 are upfront consideration and milestones of $141,450 and $950,482, respectively, related to our collaborative partners and FDA priority review voucher as compared to $0 and $25,000, 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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