$69.7 millionof 2014 first-quarter net product revenues from Jakafi® (ruxolitinib); 6 percent increase in underlying demand over fourth-quarter 2013
- Positive top-line results from Phase III study of ruxolitinib in patients with polycythemia vera keep sNDA filing on track for second quarter 2014
Abstracts for ruxolitinib in pancreatic cancer and polycythemia vera
and for IDO1 inhibitor INCB24360 in melanoma accepted for presentation
- Pivotal Phase III trial of ruxolitinib in patients with advanced pancreatic cancer initiated in addition to multiple other clinical trials that significantly broaden pipeline
Conference Call Scheduled Today at
“Underlying demand for Jakafi in myelofibrosis continues to grow, and the positive results from the pivotal Phase III trial, RESPONSE, support our confidence in the potential value that ruxolitinib can bring to patients with uncontrolled polycythemia vera,” stated Hervé Hoppenot, Incyte’s President and Chief Executive Officer. “Additionally, we’re strengthening our existing programs in JAK inhibition with new indications and combinations, advancing our novel IDO1 inhibitor in the rapidly evolving field of immunotherapy, and progressing with clinical trials with our own PI3K-delta inhibitor.”
2014 First-Quarter Financial Results
For the quarter ended
For the quarter ended
For the quarter ended
For the quarter ended
Non-Cash Stock Expense
Included in operating expenses for the quarter ended
Research and development expenses for the quarter ended
The increase in research and development expenses for the quarter ended
Selling, general and administrative expenses for the quarter ended
Increased selling, general and administrative expenses for the quarter
Interest Expense and Convertible Senior Notes
Interest expense for the quarter ended
During the quarter, the Company entered into a negotiated agreement with
a holder of the 2015 Notes pursuant to which the holder agreed to
Net loss for the quarter ended
Cash and Marketable Securities Position
Recent Clinical Highlights
Jakafi® (ruxolitinib) - a JAK1 and JAK2 Inhibitor
RESPONSE, a Phase III trial conducted under a Special Protocol
Assessment (SPA) in collaboration with
RESPONSE data will be presented in an oral session at the
Data for RELIEF, a Phase III trial measuring disease-related symptoms in patients with PV, are expected in mid-2014, followed by presentation at an upcoming scientific meeting.
The results from RECAP, the Phase II trial of ruxolitinib in combination
with capecitabine in metastatic pancreatic cancer, will be presented in
an oral session at
JANUS 1, a double-blinded, placebo-controlled Phase III trial for
advanced or metastatic pancreatic cancer, which is being conducted under
an SPA, was initiated in
Three additional blinded Phase II proof-of-concept trials of ruxolitinib focusing on survival in non-small cell lung cancer, breast cancer and colorectal cancer among patients in the subgroup identified in RECAP are open, with first patients receiving ruxolitinib in the colorectal cancer trial.
INCB39110 – a JAK1 Inhibitor
The clinical program to evaluate INCB39110 in solid tumors is planned to start with two randomized, double-blind Phase II trials in non-small cell lung cancer. The first trial is expected to initiate in the second quarter of 2014; the second trial is planned for later this year. Both trials will only include patients in the subgroup identified in RECAP with overall survival as the primary endpoint.
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. Results for the psoriasis trial were presented in early 2014, and results for the diabetic nephropathy trial are anticipated in 2015.
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.
Preliminary data from the combination trial will be presented as part of
a poster discussion at
The Investigational New Drug application for a Phase I/II trial to
evaluate the combination of INCB24360 and Merck’s investigational
anti-PD-1 immunotherapy, MK-3475, in previously treated metastatic and
recurrent non-small cell lung cancer and other advanced or metastatic
cancers has been cleared by the
INCB40093 – a PI3K-delta Inhibitor
INCB40093 is currently in a Phase I dose-escalation trial in patients
with B-lymphoid malignancies. A second trial, which started in
INC280 – a c-MET Inhibitor
Under the Incyte-Novartis collaboration and license agreement,
Additionally, there are ongoing Phase II trials in c-MET dependent advanced solid malignancies.
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.
Please see the Full Prescribing Information available at www.jakafi.com, which includes a more complete discussion of the risks associated with Jakafi.
Except for the historical information set forth herein, the matters set forth in this press release, including without limitation statements regarding the potential value that Jakafi® (ruxolitinib) can bring to patients with uncontrolled polycythemia vera; the Company’s plans and expectations with respect to Jakafi, including its potential efficacy and therapeutic and commercial value; the Company’s expectation to file a supplemental new drug application for ruxolitinib for polycythemia vera in the second quarter of 2014; the Company’s expectation of data from the RELIEF trial in mid-2014 and their presentation at a scientific meeting; the Company’s plans to begin the second Phase III trial of ruxolitinib in advanced or metastatic pancreatic cancer in the second quarter of 2014; the Company’s plans for INCB39110 to initiate two Phase II trials in patients with non-small cell lung cancer, one in the second quarter of 2014 and one later in the year; the Company’s expectation of results from the trials conducted by its collaboration partner Lilly evaluating baricitinib in patients with diabetic nephropathy in 2015; and the Company’s expectation to initiate a Phase I/II trial evaluating the combination of INCB24360 and MK-3475 in the second quarter of 2014 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
Condensed Consolidated Statements of Operations
(unaudited, in thousands, except per share amounts)
Three Months Ended
|Product revenues, net||$||69,651||$||48,289|
|Product royalty revenues||9,826||5,909|
|Costs and expenses:|
|Cost of product revenues||168||150|
|Research and development||75,585||52,763|
|Selling, general and administrative||36,974||22,261|
|Total costs and expenses||112,727||75,174|
|Loss from operations||(22,935||)||(4,097||)|
|Interest and other income, net||735||199|
|Debt exchange expense on senior note conversions||(265||)||-|
|Loss before provision for income taxes||(33,908||)||(15,626||)|
|Provision for income taxes||49||43|
|Basic and diluted net loss per share||$||(0.21||)||$||(0.12||)|
Shares used in computing basic and diluted
Net loss per share
Condensed Consolidated Balance Sheet Data
|Cash, cash equivalents, and short-term marketable securities||$||519,231||$||509,004|
|Accounts receivable, net||46,394||35,374|
|Convertible senior notes(1)||665,222||661,567|
|Total stockholders’ deficit||(162,422||)||(193,108||)|
(1) Net of unamortized debt discount of
Pamela M. Murphy
Vice President, Investor Relations & Corporate Communications