The Drive to Discover. The Experience to Deliver.
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|Incyte Reports 2013 Fourth-Quarter and Year-End Financial Results; Provides 2014 Financial Guidance; Updates Shareholders on Key Clinical Programs|
Conference Call Scheduled Today at
“I have great confidence that
“Beyond our JAK programs, we have a clinical pipeline that includes oral inhibitors of IDO1 and PI3K-delta, and the recent announcement regarding our clinical trial collaboration with Merck is an important step to furthering our understanding of the role of our oral IDO1 inhibitor in the rapidly evolving field of immunotherapy.”
2013 Fourth-Quarter and Full-Year Financial Results
Net loss for the quarter ended
Net loss for the full year ended
For the quarter and full year ended
For the quarter and full year ended
For the quarter and full year ended
For the quarter and full year ended
Non-Cash Stock Option Expense
Included in net loss for the quarter ended
Included in net loss for the full year 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
Interest and Other Expenses Related to Convertible Senior Notes
During the fourth quarter of 2013, the Company completed a private
During the year, the Company entered into separately negotiated
agreements with certain holders of the 2015 Notes pursuant to which such
holders agreed to exchange
Interest expense for the quarter and full year ended
Cash and Marketable Securities Position
2014 Financial Guidance
Product Revenues: The Company expects that Jakafi net product revenues
will be in the range of
Contract Revenues: The Company expects to receive a
Research and Development Expenses: The Company expects that research and
development expenses will be in the range of
Selling, General and Administrative Expenses: The Company expects
selling, general and administrative expenses to be in the range of
Interest Expense: The Company expects interest expense to be
Recent Clinical Highlights
Jakafi® (ruxolitinib) - a JAK1 and JAK2 Inhibitor
Data from multiple presentations at the 2013
RESPONSE, a Phase III study being conducted under a Special Protocol
Assessment (SPA) in collaboration with
RELIEF is an ongoing fully enrolled Phase III trial measuring disease-related symptoms in patients with PV. Data are expected in mid-2014.
Three additional blinded Phase II proof-of-concept trials focusing on survival in non-small cell lung cancer, breast cancer and colon cancer studying patients in the subgroup identified in RECAP are also expected to initiate in the first half of 2014.
Baricitinib - a JAK1 and JAK2 Inhibitor
The Phase III clinical program to evaluate baricitinib in patients with rheumatoid arthritis, being conducted by the Company’s collaboration partner Lilly, is ongoing.
Phase II trials in patients with moderate-to-severe psoriasis and patients with diabetic nephropathy are also ongoing, with results anticipated in 2014 and 2015, respectively.
INCB39110 – a JAK1 Inhibitor
The clinical program to evaluate INCB39110 in solid tumors is planned to start with two blinded Phase II trials of INCB39110 in non-small cell lung cancer that are expected to initiate in the first half of 2014. The primary endpoint of both studies will be overall survival.
INCB47986 – a JAK1 Inhibitor
A Phase I clinical trial of a second JAK1 inhibitor, INCB47986, in healthy volunteers has been completed, and a Phase II trial of the compound in patients with rheumatoid arthritis is planned for the first half of 2014.
INCB24360 – an IDO1 Inhibitor
INCB24360 is currently being evaluated in a Phase I/II trial in combination with ipilimumab for metastatic melanoma and in a Phase II trial as monotherapy for ovarian cancer. Based on preclinical data that suggest synergy in combining an IDO1 inhibitor with checkpoint inhibitors for improved anti-tumor response, the Company has established a clinical trial collaboration to evaluate the combination of INCB24360 and Merck’s investigational anti-PD-1 immunotherapy, MK-3475, in a Phase I/II study in previously treated metastatic and recurrent non-small cell lung cancer and other advanced or metastatic cancers. The study is expected to initiate in the first half of 2014. The Company is also working to establish additional clinical collaborations with other companies, cancer networks and academia.
INCB40093 – a PI3K-delta Inhibitor
INCB40093 is currently in a Phase I dose-escalation trial in patients
with B-lymphoid malignancies. A Phase I study in combination with the
Company’s JAK1 inhibitor, INCB39110, in the same patient group was
INC280 – a c-MET Inhibitor
Under the Incyte-Novartis collaboration and license agreement,
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.
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 while taking Jakafi. Tell your healthcare provider if you develop symptoms such as chills, nausea, vomiting, aches, weakness, fever, or painful skin rash or blisters.
The most common side effects of Jakafi include dizziness and headache.
These are not all the possible side effects of Jakafi. Ask your healthcare provider or pharmacist 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 liver or kidney problems, are on dialysis, or have any other medical condition. Do not drink grapefruit juice while taking 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, contract revenues, cost of product revenues, research and development expenses, selling, general and administrative expenses and interest expense; the Company’s plans and expectations for the future, including the potential for substantial growth for Jakafi® (ruxolitinib) in polycythemia vera, and the possibility that JAK inhibition may extend and improve patient outcomes in pancreatic cancer and other solid tumors; the Company’s plans and expectations with respect to Jakafi, including its potential efficacy and therapeutic and commercial value, its potential to improve survival and bone marrow fibrosis, and its potential in other oncologic indications; the Company’s expectation to file a supplemental new drug application for ruxolitinib for polycythemia vera in the first half of 2014; the Company’s expectation of results from the RELIEF trial in mid-2014; regarding ruxolitinib in advanced or metastatic pancreatic cancer, the possibility that one trial with sufficiently robust results may be sufficient to support approval and that two Phase III trials are planned and expected to begin in the first half of 2014; the Company’s expectation to initiate three additional Phase II proof-of-concept trials evaluating ruxolitinib in non-small cell lung cancer, breast cancer and colon cancer in patients in the subgroup identified in RECAP in the first half of 2014; the Company’s expectation of results from the trials conducted by its collaboration partner Lilly evaluating baricitinib in patients with moderate-to-severe psoriasis and diabetic nephropathy in 2014 and 2015, respectively; the Company’s plans for INCB39110 in oncologic indications, including initiating two Phase II trials in patients with non-small cell lung cancer in the first half of 2014; the Company’s plans for a Phase II trial of INCB47986 in patients with rheumatoid arthritis for the first of 2014; the Company’s expectation to initiate a Phase I/II study evaluating the combination of INCB24360 and MK-3475 in the first half of 2014; and the Company’s plans to establish additional clinical collaborations for its IDO1 inhibitor contain predictions, estimates and other forward-looking statements.
These forward-looking statements are based on the Company’s current
expectations and subject to risks and uncertainties that may cause
actual results to differ materially, including unanticipated
developments in and risks related to 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
Net loss - as adjusted, and basic and diluted net loss per share - as
adjusted (excluding a one-time charge related to the difference between
the face amount and carrying value related to the repurchase of 2015
Notes) is a non-GAAP financial measure and should not be considered a
replacement for GAAP results. A reconciliation of this non-GAAP
financial measure to the most directly comparable GAAP financial measure
is presented above. The Company believes that presentation of this
non-GAAP financial measure provides useful supplementary information to,
and facilitates additional analysis by, investors by showing the effect
of the one-time repurchase of a portion of the outstanding 2015 Notes on
our net loss for the three months and twelve months ended
The information in the press releases should be considered accurate only as of the date of the document or presentation. We disclaim any obligation to supplement or update the information in these documents or presentations.
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