Incyte Reports 2014 Fourth-Quarter and Year-End Financial Results; Provides 2015 Financial Guidance; Updates Shareholders on Key Clinical Programs
$106 millionof 2014 fourth-quarter net product revenues from Jakafi® (ruxolitinib), representing 46 percent growth over the same period last year
$358 millionof 2014 full-year net product revenues from Jakafi, representing 52 percent growth over last year
2015 guidance for Jakafi net product revenues in the range of
$525 million to $565 million, reflecting continued growth in underlying demand in myelofibrosis (MF) and including revenue from the launch in polycythemia vera (PV)
- Recruitment continuing across clinical development portfolio in multiple pivotal and proof-of-concept trials
Conference Call Scheduled Today at
“Our strategy is to invest in innovative science, creating new medicines
which can make a positive impact on patients’ lives,” stated Hervé
Hoppenot, Incyte’s President and Chief Executive Officer. “The
commercial momentum at
Jakafi® is approved by the
2014 Fourth-Quarter and Full-Year Financial Results
For the quarter ended
For the quarter and full year ended
For the quarter ended
For the quarter ended
Research and development expenses for the quarter and full year ended
The increase in research and development expenses for the quarter and
full year ended
Selling, general and administrative expenses for the quarter and full
Increased selling, general and administrative expenses for the quarter
and full year ended
Non-Cash Stock Expense
Included in operating expenses for the quarter ended
Interest expense for the quarter and full year ended
Net loss for the quarter ended
Included in the net loss in 2013 was
Cash and Marketable Securities Position
2015 Financial Guidance
Product Revenues: The Company expects that
Jakafi net product revenues will be in the range of
Research and Development Expenses: The
Company expects that research and development expenses will be in the
Selling, General and Administrative Expenses:
The Company expects selling, general and administrative expenses to be
in the range of
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 underway, and the Company expects data from both studies in 2016. Results from three Phase II trials of ruxolitinib, being conducted in colorectal, breast and non-small cell lung cancer (NSCLC) patients, are also expected during 2016.
Each of these trials uses the same approach to patient selection, which is based on the presence of onco-inflammation as assessed by elevated systemic C-reactive protein (CRP).
INCB39110 & INCB52793 – JAK1-Selective Inhibitors
INCB39110 is in two Phase II lung cancer trials, one in combination with docetaxel and the other in combination with erlotinib, and the Company plans to begin a first line pancreatic cancer study in combination with gemcitabine and nab-paclitaxel in the second half of 2015. INCB39110 is also being studied in combination with the Company’s PI3Kδ inhibitor INCB40093 in B-cell malignancies, initial results of which are expected in the first half of 2015.
INCB52793 is now in a Phase I/II dose-escalation trial in liquid tumors, and the Company has plans to initiate both mono- and combination-therapy trials, potentially in multiple myeloma.
epacadostat (INCB24360) – IDO1 Inhibitor
The trials under the four clinical trial agreements to evaluate epacadostat in combination with immune checkpoint inhibitors are now in progress. The trials are evaluating epacadostat in combination with Merck & Co’s PD-1 inhibitor Keytruda® (pembrolizumab), AstraZeneca’s investigational PD-L1 inhibitor, MEDI4736, Bristol-Myers Squibb’s PD-1 inhibitor, Opdivo® (nivolumab), and Genentech’s investigational PD-L1 inhibitor, MPDL3280A. Tumor types under investigation include NSCLC, melanoma, head and neck, colorectal, ovarian and pancreatic cancer, as well as lymphoma.
INCB50465 & INCB40093 – PI3Kδ Inhibitors
INCB50465, a highly potent PI3Kδ inhibitor, has now entered Phase I/II development, and INCB40093 is advancing in both monotherapy and combination proof-of-concept trials. The combination of INCB40093 and the JAK1-selective inhibitor INCB39110 is being tested in a Phase I/II trial in B-cell malignancies, and data from this study is expected in the first half of 2015.
INCB54828 – FGFR Inhibitor
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. The Company plans to advance its selective FGFR inhibitor INCB54828 into clinical development in the first half of 2015.
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 plans to begin clinical trials of INCB54329, its BRD inhibitor, in the first half of 2015.
baricitinib – JAK1 and JAK2 Inhibitor
capmatinib (INC280) – c-MET Inhibitor
Capmatinib may have potential for use in both mono- and combination
therapy regimens, including the recently announced clinical
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, including without limitation statements
regarding the Company’s financial guidance about expected net product
revenues for Jakafi® (ruxolitinib), research and development expenses,
and selling, general and administrative expenses; the Company’s strategy
and plans and expectations for the future; the Company’s expectation of
data from the JANUS 1 and JANUS 2 trials of ruxolitinib in second line
metastatic pancreatic cancer and results from the three Phase II trials
of ruxolitinib in colorectal, breast and non-small cell lung cancer in
2016; the Company’s plans for INCB39110 to begin a first line pancreatic
cancer study in the second half of 2015; 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; the Company’s plans
to initiate both mono- and combination-therapy trials for INCB52793,
potentially in multiple myeloma; the Company’s expectation to initiate
the first clinical trials under the
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||
Twelve Months Ended
|Product revenues, net||$||106,049||$||72,854||$||357,562||$||235,443|
|Product royalty revenues||14,707||8,358||48,966||28,251|
|Costs and expenses:|
|Cost of product revenues||2,428||167||3,004||630|
|Research and development||98,717||75,020||347,523||260,436|
|Selling, general and administrative||48,452||38,028||165,772||109,983|
|Total costs and expenses||149,597||113,215||516,299||371,049|
|Loss from operations||(25,624||)||(16,143||)||(4,804||)||(16,102||)|
|Interest and other income, net||940||497||3,350||1,324|
|Debt exchange expense||-||(221||)||(265||)||(11,484||)|
|Loss on repurchase/redemption of convertible senior notes||-||(17,934||)||-||(17,934||)|
|Loss before income taxes||(37,200||)||(42,733||)||(48,547||)||(82,848||)|
|(Benefit) provision for income taxes||(256||)||137||(66||)||299|
|Net loss per basic and diluted share||$||(0.22||)||$||(0.26||)||$||(0.29||)||$||(0.56||)|
Shares used in computing basic and diluted net loss per share
Condensed Consolidated Balance Sheet Data
|(unaudited, in thousands)|
|December 31,||December 31,|
Cash, cash equivalents, and short-term marketable securities
|Accounts receivable, net||57,933||35,374|
|Convertible senior notes(1)||689,118||661,567|
|Total stockholders’ deficit||(81,628||)||(193,108||)|
(1) Includes short term and long term Convertible Senior Notes net of
unamortized debt discount of
Michael Booth, DPhil
Vice President, Investor Relations