Incyte Reports 2015 First-Quarter Financial Results and Updates Shareholders on Key Clinical Programs
$115 millionof 2015 first-quarter net product revenues from Jakafi® (ruxolitinib), representing 66 percent growth over the same period last year
$25 millionmilestone received from Novartisrelated to the approval of Jakavi® (ruxolitinib) for polycythemia vera in Europe; $16 millionproduct royalties from sales of Jakavi, representing 60 percent growth over the same period last year
- Primary endpoint met in second Phase III trial of baricitinib in rheumatoid arthritis; additional data disclosures expected during 2015
- Recruitment continuing across clinical development portfolio in multiple pivotal and proof-of-concept trials
Conference Call Scheduled Today at
“We are very pleased with the ongoing commercialization of Jakafi. It is establishing itself as the standard of care in patients with intermediate or high-risk myelofibrosis, and the initial uptake of Jakafi in patients with uncontrolled PV has also met our expectations,” stated Hervé Hoppenot, Incyte’s President and Chief Executive Officer. “We continue to recruit patients into the multiple clinical trials being run across our broad clinical portfolio, and we have recently showcased the strength of our emerging development pipeline, which provides us with multiple potential routes to future success.”
Jakafi® is approved by the
2015 First-Quarter Financial Results
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Recent Clinical Highlights
Jakafi (ruxolitinib) – JAK1 and JAK2 Inhibitor
The pivotal Phase III JANUS 1 and JANUS 2 studies of ruxolitinib in second line metastatic pancreatic cancer are ongoing. Patient accrual into JANUS 1 is running ahead of JANUS 2, and while the Company continues to expect data from JANUS 1 in 2016, results from JANUS 2 are now expected at a later date. The Company believes, if the results are sufficiently robust, that JANUS 1 could support an application for approval as a single pivotal trial.
Three Phase II trials of ruxolitinib are being conducted in colorectal, breast and non-small cell lung cancer (NSCLC) patients. Competitive trial recruitment, including from studies of immune-directed agents, has significantly impacted recruitment into the NSCLC trial. Recruitment into the colorectal and breast cancer trials is as expected.
INCB39110 & INCB52793 – JAK1-Selective Inhibitors
INCB39110 is in two Phase II NSCLC trials, one in combination with docetaxel and the other in combination with erlotinib. INCB39110 is also in a dose-expansion proof-of-concept trial, in combination with gemcitabine and nab-paclitaxel, for the first-line treatment of patients with pancreatic cancer.
INCB39110 is also being studied in combination with the Company’s PI3Kδ
inhibitor INCB40093 in B-cell malignancies, initial results of which are
to be presented at the 2015
INCB52793 is in a Phase I/II dose-escalation trial in liquid tumors.
INCB50465 & INCB40093 – PI3Kδ Inhibitors
The combination of INCB40093 and the JAK1-selective inhibitor INCB39110
is being tested in a Phase I/II trial in B-cell malignancies, initial
results of which are to be presented at the 2015
INCB50465 is a highly-potent PI3Kδ inhibitor and an open-label, dose-escalation study of INCB50465 in subjects with previously treated B-cell malignancies has been initiated.
epacadostat (INCB24360) – IDO1 Inhibitor
Four clinical trials to evaluate epacadostat in combination with immune
checkpoint inhibitors are all recruiting patients. These trials are
evaluating epacadostat in combination with Merck & Co’s PD-1 inhibitor
INCB54828 – FGFR Inhibitor
In the first quarter of 2015, INCB54828 entered an open-label, dose-escalation study in subjects with advanced malignancies. The FGFR family of receptor tyrosine kinases can act as oncogenic drivers in a number of liquid and solid tumor types, most notably squamous NSCLC, gastric and bladder cancer, and glioblastoma.
INCB54329 – BRD Inhibitor
Bromodomains (BRDs) are a family of proteins which play important roles in mediating gene transcription, most notably by facilitating the expression of oncogenes such as MYC, one of the most frequently dysregulated oncogenes in all human cancer. The Company expects to begin clinical trials of INCB54329, its BRD inhibitor, in the second quarter of 2015.
baricitinib – JAK1 and JAK2 Inhibitor
RA-BUILD is part of the global Phase III program of baricitinib in RA.
Top-line results from RA-BEACON were announced in
The Company and Lilly also expect to share results of two further Phase III studies in various disclosures during 2015.
capmatinib (INC280) – c-MET Inhibitor
Conference Call Information
If you are unable to participate, a replay of the conference call will
be available for 30 days. The replay dial-in number for
The conference call will also be webcast live and can be accessed at www.incyte.com under Investor Relations – Events and Webcasts.
About Jakafi® (ruxolitinib)
Jakafi is a first-in-class JAK1/JAK2 inhibitor approved by the
Jakafi is also indicated for treatment of people with intermediate or high-risk myelofibrosis (MF), including primary MF, post–polycythemia vera MF, and post–essential thrombocythemia MF.
Jakafi is marketed by
Important Safety Information
Jakafi can cause serious side effects, including:
Low blood counts: Jakafi may cause your platelet, red blood cell, or white blood cell counts to be lowered. If you develop bleeding, stop taking Jakafi and call your healthcare provider. Your healthcare provider will perform blood tests to check your blood counts before you start Jakafi and regularly during your treatment. Your healthcare provider may change your dose of Jakafi or stop your treatment based on the results of your blood tests. Tell your healthcare provider right away if you experience unusual bleeding, bruising, fatigue, shortness of breath, or a fever.
Infection: You may be at risk for developing a serious infection during treatment with Jakafi. Tell your healthcare provider if you develop any of the following symptoms of infection: chills, nausea, vomiting, aches, weakness, fever, painful skin rash or blisters.
Skin cancers: Some people who take Jakafi have developed certain types of non-melanoma skin cancers. Tell your healthcare provider if you develop any new or changing skin lesions.
The most common side effects of Jakafi include: anemia, low platelet count, bruising, dizziness, headache.
These are not all the possible side effects of Jakafi. Ask your pharmacist or healthcare provider for more information. Tell your healthcare provider about any side effect that bothers you or that does not go away.
Before taking Jakafi, tell your healthcare provider about all the medications, vitamins, and herbal supplements you are taking and all your medical conditions, including if you have an infection, have or had tuberculosis (TB), or have been in close contact with someone who has TB, have or had liver or kidney problems, are on dialysis, had skin cancer or have any other medical condition. Take Jakafi exactly as your healthcare provider tells you. Do not change or stop taking Jakafi without first talking to your healthcare provider. Do not drink grapefruit juice while on Jakafi.
Women should not take Jakafi while pregnant or planning to become pregnant, or if breast-feeding.
Except for the historical information set forth herein, the matters set
forth in this press release contain predictions, estimates and other
forward-looking statements, including without limitation statements
regarding: the Company’s emerging development pipeline and the potential
success of any of those product candidates; whether Jakafi will
eventually become the standard of care for patients with intermediate or
high-risk myelofibrosis; the Company’s plans and expectations regarding
its European headquarters and European clinical operations; whether the
data from the JANUS 1 trial will be sufficiently robust to allow for
product registration; the expected timing of data from the JANUS 1 and
JANUS 2 trials; and the ability to recruit into the three Phase II
trials of ruxolitinib in colorectal, breast and NSCLC; the Company’s
expectation of results in the first half of 2015 from the study of
INCB39110 in combination with INCB40093 in B-cell malignancies and from
the study of INCB39110 in combination with the Company’s PI3Kδ inhibitor
INCB40093 in B-cell malignancies, and the plan to present initial
results of each study at the 2015
These forward-looking statements are based on the Company’s current
expectations and subject to risks and uncertainties that may cause
actual results to differ materially, including unanticipated
developments in and risks related to the efficacy or safety of Jakafi,
the acceptance of Jakafi in the marketplace, risks related to market
competition, the results of further research and development, risks and
uncertainties associated with sales, marketing and distribution
requirements, risks that results of clinical trials may be unsuccessful
or insufficient to meet applicable regulatory standards, the ability to
enroll sufficient numbers of subjects in clinical trials, other market,
economic or strategic factors and technological advances, unanticipated
delays, the ability of the Company to compete against parties with
greater financial or other resources, risks associated with the
Company's dependence on its relationships with its collaboration
partners, and other risks detailed from time to time in the Company’s
reports filed with the
Condensed Consolidated Statements of Operations
(unaudited, in thousands, except per share amounts)
Three Months Ended
|Product revenues, net||$||115,330||$||69,651|
|Product royalty revenues||15,673||9,826|
|Costs and expenses:|
|Cost of product revenues||2,974||168|
|Research and development||118,365||75,585|
|Selling, general and administrative||44,871||36,974|
|Total costs and expenses||166,210||112,727|
|Loss from operations||(6,935||)||(22,935||)|
|Interest and other income, net||1,630||735|
|Debt exchange expense||—||(265||)|
|Loss before income taxes||(17,992||)||(33,908||)|
|Provision for income taxes||367||49|
|Net loss per basic and diluted share||$||(0.11||)||$||(0.21||)|
Shares used in computing basic and diluted net loss per share
Condensed Consolidated Balance Sheet Data
(unaudited, in thousands)
|Cash, cash equivalents, and short-term marketable securities||$||585,424||$||600,263|
|Long term investment - Agenus Inc.||39,829||—|
|Convertible senior notes(1)||697,547||689,118|
|Total stockholders’ deficit||(41,413||)||(81,628||)|
|(1) Net of unamortized debt discount of $143 million and $152 million at March 31, 2015, and December 31, 2014, respectively.|
Michael Booth, DPhil
Vice President, Investor Relations