$54.1 millionof second-quarter net product revenues from Jakafi, reflecting solid growth in underlying demand
2013 guidance for Jakafi net product revenues increased to range of
$220 million to $230 million
- New data presented for Jakafi suggest an impact on bone marrow fibrosis and provide further evidence of a survival advantage in myelofibrosis patients
- New dosing guidance for myelofibrosis patients with low platelet counts added to prescribing information for Jakafi
Conference Call Scheduled Today at
“The underlying demand for Jakafi was strong in the second quarter,
leading to our decision to increase guidance for 2013,” stated Paul A.
Friedman, M.D., Incyte’s President and Chief Executive Officer. “Looking
forward, we expect the positive data recently presented at the
In the three-year follow-up analysis of COMFORT-II, a 52 percent reduction in risk of death was observed in the patients treated with Jakafi as compared to patients treated with best available therapy, and the estimated probability of overall survival at three years in patients with intermediate or high-risk myelofibrosis treated with Jakafi was 81 percent.
2013 Second-Quarter Financial Results and Guidance Updates
Total revenues for the quarter ended
Jakafi net product revenues were
The Company now expects that 2013 net product revenues from Jakafi will
be in the range of
Product royalties from sales of Jakavi outside
Also included in revenues for the second quarter of 2013 were contract
Net Income (Loss)
Net loss for the quarter ended
Non-Cash Stock Option Expense
Non-cash expense related to employee stock options for the second
quarter of 2013 was
Research and development expenses for the quarter and six months ended
Selling, general and administrative expenses for the quarter and six
Interest Expense and 4.75% Convertible Senior Notes
Interest expense for the quarter and six months ended
During the second quarter the Company entered into separately negotiated
agreements with certain holders of the Company’s 4.75% Senior Notes
pursuant to which such holders agreed to exchange
As a result of the reduction in the outstanding principal balance of the
4.75% Senior Notes, the Company now expects interest expense to be
Recent Clinical Highlights
Jakafi® (ruxolitinib) - a JAK1 and JAK2 Inhibitor
Three-year data from the Phase III COMFORT-II trial presented at the
In an exploratory analysis of long-term data from an ongoing Phase I/II
trial presented at the
- Polycythemia Vera
RESPONSE, a Phase III study being conducted under a Special Protocol
Assessment (SPA) in collaboration with
RELIEF is an ongoing Phase III trial measuring disease-related symptoms
in patients with PV, and not being part of the SPA agreement with the
- Pancreatic Cancer
A randomized Phase II trial of ruxolitinib in combination with capecitabine is ongoing with approximately 135 patients with recurrent or treatment refractory metastatic pancreatic cancer (the RECAP trial). The primary endpoint is overall survival, and top-line results are expected later in the third quarter of 2013.
- Other Potential Indications
Multiple investigator-sponsored trials evaluating ruxolitinib in oncologic indications are ongoing.
Baricitinib - a JAK1 and JAK2 Inhibitor
The 52-week efficacy and safety data from the open-label, long-term
extension of the Phase IIb JADA study of baricitinib in patients with
active rheumatoid arthritis, conducted by the Company’s collaboration
The Phase III clinical program to evaluate baricitinib in rheumatoid arthritis is ongoing. Two Phase II trials in patients with moderate-to-severe psoriasis and in patients with diabetic nephropathy are also underway.
INC280 (formerly INCB28060) – a c-MET Inhibitor
Under the Incyte-Novartis licensing agreement, further development of
this compound is being conducted by
INCB24360 – an IDO1 Inhibitor
Final results from the Phase I clinical trial of INCB24360, which were
presented at the American Society of Clinical Oncology (
INCB24360 is currently in Phase I/II clinical development for metastatic melanoma in combination with ipilimumab and as monotherapy for ovarian cancer.
INCB39110 – a JAK1 Inhibitor
Three proof-of-concept studies evaluating INCB39110 in patients with myelofibrosis, psoriasis and rheumatoid arthritis are underway, with results expected in the second half of 2013. The results of these studies are expected to provide information about the most appropriate indications for further development.
INCB47986 – a JAK1 Inhibitor
A second JAK1 inhibitor, INCB47986, is currently in Phase I clinical development, and future studies will focus on its use in hematology and oncology indications.
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 financial guidance about expected net product revenues and interest expense, our plans and expectations with respect to Jakafi (ruxolitinib), including the potential efficacy and therapeutic and commercial value of Jakafi, our expectation that the positive data recently presented at EHA regarding the overall survival advantage seen with long-term use of Jakafi will continue to generate confidence in the therapeutic value of Jakafi, our expectation of results from the RESPONSE trial evaluating ruxolitinib in PV in early 2014 and the filing of a supplemental new drug application in the first half of 2014, our expectation to submit results from the RELIEF trial to support labeling claims on symptomatic benefit of ruxolitinib in PV, our expectation of top-line results from the RECAP trial in the third quarter of 2013, our belief that INCB24360 may represent a new treatment option for advanced malignancies, our expectation of results from the three proof-of-concept studies evaluating INCB39110 in patients with myelofibrosis, psoriasis and rheumatoid arthritis in the second half of 2013 and these results being expected to provide information as to the most appropriate indications for further development, and our expectation that future studies of INCB47986 will focus on its use in hematology and oncology indications, contain predictions, estimates and other forward-looking statements.
These forward-looking statements are based on 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 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
or economic factors and technological advances, unanticipated delays,
the ability of
Condensed Consolidated Statements of Operations
(in thousands, except per share amounts)
|Three Months Ended||Six Months Ended|
|Product revenues, net||$||54,099||$||29,727||$||102,388||$||49,006|
|Product royalty revenues||5,800||-||11,709||-|
|Costs and expenses:|
|Cost of product revenues||157||16||308||27|
|Research and development||60,950||51,588||113,713||100,548|
|Selling, general and administrative||23,249||19,719||45,509||41,115|
|Total costs and expenses||84,356||71,323||159,530||141,690|
|Income (loss) from operations||17,319||15,219||13,222||(18,968||)|
|Interest and other income, net||245||315||444||366|
|Debt exchange expense||(9,771||)||-||(9,771||)||-|
|Income (loss) before income taxes||(2,500||)||4,104||(18,127||)||(41,322||)|
|Provision for income taxes||71||67||113||67|
|Net income (loss)||$||(2,571||)||$||4,037||$||(18,240||)||$||(41,389||)|
|Net income (loss) per share|
|Shares used in computing basic and diluted net income (loss) per share|
Condensed Consolidated Balance Sheet Data
|June 30,||December 31,|
|Cash, cash equivalents, and short-term marketable securities||277,453||228,418|
|Accounts receivable, net||27,522||70,951|
|Convertible senior notes(1)||214,530||322,043|
|Convertible subordinated notes||9,287||9,033|
|Total stockholders’ deficit||(27,786||)||(174,957||)|
|(1) Net of unamortized debt discount of $41.8 million and $78.0 million at June 30, 2013 and December 31, 2012, respectively.|
Pamela M. Murphy
Vice President, Investor Relations & Corporate Communications