$60.2 millionof third-quarter net product revenues from Jakafi, reflecting solid growth in underlying demand
- Top-line results from Phase II trial of ruxolitinib in patients with refractory metastatic pancreatic cancer suggest a demonstrable survival benefit in a well-defined subgroup of patients
- Positive Phase II data from trials of oral JAK1 inhibitor, INCB39110, in psoriasis and rheumatoid arthritis presented at recent scientific meetings
Conference Call Scheduled Today at
“The growth of Jakafi remains strong, and we’re encouraged by the
sustained steady rate of new prescriptions for patients with
myelofibrosis and continued evidence that physicians are successfully
individualizing dosing,” stated
2013 Third-Quarter Financial Results
Total revenues for the quarter ended
Jakafi net product revenues were
Product royalties from sales of Jakavi® (ruxolitinib) outside
Also included in revenues for each of the quarters ended
Net loss for the quarter ended
Non-Cash Stock Option Expense
Non-cash expense related to employee stock options for the third quarter
of 2013 was
Research and development expenses for the quarter and nine months ended
Selling, general and administrative expenses for the quarter and nine
Interest Expense and 4.75% Convertible Senior Notes
Interest expense for the quarter and nine months ended
During the third 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
Recent Clinical Highlights
Jakafi® (ruxolitinib) - a JAK1 and JAK2 Inhibitor
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. Once completed, the trial results, if positive, are expected to be submitted to support labeling claims regarding the symptomatic benefit of ruxolitinib in PV. Data are expected in mid-2014.
An overall survival analysis of top-line results of the Phase II proof-of-concept trial (RECAP) of ruxolitinib in combination with capecitabine in patients with refractory metastatic pancreatic cancer demonstrated a hazard ratio of 0.79 and a pre-specified subgroup analysis achieved a significant benefit with a hazard ratio of 0.47. The results of the randomized, double-blind, placebo-controlled trial are expected to be used to support a pivotal registration program in metastatic pancreatic cancer as well as several Phase II trials in other solid tumors. Full results of the RECAP trial are expected to be presented at a future scientific meeting.
A Phase I trial to evaluate the safety and tolerability of ruxolitinib in combination with gemcitabine with or without nab-paclitaxel in patients with advanced solid tumors is ongoing.
Multiple investigator-sponsored trials are ongoing to evaluate ruxolitinib in oncologic indications, including advanced hematologic malignancies, relapsed or refractory acute leukemia, lymphoma and breast cancer.
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
A Phase II trial in patients with moderate-to-severe psoriasis is also ongoing, with results anticipated in 2014. The results from an ongoing Phase II trial in patients with diabetic nephropathy are expected in 2015.
INCB39110 – a JAK1 Inhibitor
Results of a 28-day, double-blind, placebo-controlled, dose-escalation
Phase II proof-of-concept clinical trial evaluating INCB39110 in 50
patients with chronic plaque psoriasis were presented at the 2013
Results of a 12-week, placebo-controlled, dose-escalation Phase II
proof-of-concept clinical trial evaluating INCB39110 in 60 patients with
active rheumatoid arthritis were presented at the 2013
Data from the Phase II proof-of-concept trial evaluating INCB39110 in
patients with myelofibrosis are expected to be presented at the 2013
A Phase I clinical trial to evaluate the safety and tolerability of INCB39110 in combination with gemcitabine and nab-paclitaxel in patients with advanced solid tumors was initiated in July.
INCB47986 – a JAK1 Inhibitor
A second JAK1 inhibitor, INCB47986, is currently being evaluated in a Phase I clinical trial in patients with advanced malignancies.
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.
An investigator-sponsored trial is underway to evaluate INCB24360 in patients with myelodysplastic syndrome (MDS), and a cooperative group study is underway to evaluate the IDO1 inhibitor in combination with vaccine therapy in patients with melanoma.
INCB40093 – a PI3K-delta Inhibitor
INCB40093 has completed single- and multi-dose Phase I studies in healthy volunteers and is currently in a Phase I dose-escalation trial in patients with B-lymphoid malignancies.
INC280 – a c-MET Inhibitor
Under the Incyte-Novartis Collaboration and License Agreement, further
development of this compound is being conducted by
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 plans and expectations with respect to Jakafi® (ruxolitinib), including its potential efficacy and therapeutic and commercial value, its potential approval in polycythemia vera in late 2014 and potential benefit in pancreatic cancer and opportunities in other solid tumors; the Company’s 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; the Company’s expectation of results from the RELIEF trial in mid-2014 and the submission of those results to support labeling claims on symptomatic benefit of ruxolitinib in PV; the Company’s expectation of using the results from the RECAP trial to support a pivotal registration program in metastatic pancreatic cancer as well as several Phase II trials in other solid tumors and to present the results at a future scientific meeting; the Company’s expectation of results from the trials evaluating baricitinib in patients with moderate-to-severe psoriasis and diabetic nephropathy in 2014 and 2015, respectively; and the Company’s expectation to present results from the proof-of-concept trial evaluating INCB39110 in patients with myelofibrosis at the 2013 ASH annual meeting, 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
(in thousands, except per share amounts)
|Three Months Ended||Nine Months Ended|
|Product revenues, net||$||60,201||$||43,695||
|Product royalty revenues||8,184||-||19,893||-|
|Costs and expenses:|
|Cost of product revenues||155||31||463||58|
|Research and development||71,704||50,079||185,417||150,627|
|Selling, general and administrative||26,447||20,520||71,956||61,634|
|Total costs and expenses||98,306||70,630||257,836||212,319|
|Income (loss) from operations||(13,183||)||(10,138||)||39||(29,106||)|
|Interest and other income, net||385||27||829||393|
|Debt exchange expense||(1,491||)||-||(11,262||)||-|
|Loss before income taxes||(21,988||)||(21,684||)||(40,114||)||(63,006||)|
|Provision for income taxes||49||26||162||93|
|Basic and diluted net loss per share||
|Shares used in computing basic and diluted net loss per share||155,067||130,851||143,899||129,093|
Condensed Consolidated Balance Sheet Data
|September 30,||December 31,|
|Cash, cash equivalents, and short-term marketable securities||291,174||228,418|
|Accounts receivable, net||33,197||70,951|
|Convertible senior notes(1)||187,136||322,043|
|Convertible subordinated notes||-||9,033|
|Total stockholders’ equity (deficit)||28,791||(174,957||)|
|(1) Net of unamortized debt discount of $31.9 million and $78.0 million at September 30, 2013 and December 31, 2012, respectively.|
Pamela M. Murphy
Vice President, Investor Relations & Corporate Communications