Incyte Reports 2014 Second-Quarter Financial Results and Updates Shareholders on Key Clinical Programs
$84.0 million of 2014 second-quarter net product revenues from Jakafi® (ruxolitinib), representing 55 percent growth over the same period last year- 2014 guidance for Jakafi net product revenues increased to range of
$330 million to $340 million , driven by strong underlying demand - Timely initiation of key pipeline programs, including initiation of two pivotal trials of ruxolitinib in pancreatic cancer and three proof of concept trials of ruxolitinib in other solid tumors
- Multiple combination therapy clinical trial agreements signed for IDO1 inhibitor INCB24360, with first such trial initiated in July
Conference Call Scheduled Today at
“We continue the successful commercialization of Jakafi in myelofibrosis, and I am encouraged by the rapid regulatory and clinical advances we are making across the breadth of our development pipeline,” stated Hervé Hoppenot, Incyte’s President and Chief Executive Officer. “The field of oncology is evolving at an unprecedented pace, and Incyte’s scientific and commercial progress serves to highlight our central position in the ongoing transformation in how cancer patients are treated.”
2014 Second-Quarter Financial Results
Revenues
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The Company now expects that 2014 net product revenues from Jakafi will be in the range of
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Non-Cash Stock Expense
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Operating Expenses
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Increased selling, general and administrative expenses for the quarter and six months ended
Interest Expense
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Net Loss
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Cash and Marketable Securities Position
As of
Recent Clinical Highlights
Jakafi® (ruxolitinib) – a JAK1 and JAK2 Inhibitor
Myeloproliferative Neoplasms
The product label for Jakafi was recently expanded to include overall survival data and additional safety and dosing information. This new information is based on three-year data from the two pivotal Phase III trials in myelofibrosis patients, COMFORT-I and II.
Positive data from RESPONSE, a Phase III trial conducted under a Special Protocol Assessment (SPA) from the
As previously announced, the RELIEF trial measuring disease-related symptoms in patients with PV did not meet its primary endpoint of the proportion of subjects achieving a ≥ 50% reduction in a cluster of PV-related symptoms at week 16 compared to baseline, although positive trends in favor of ruxolitinib versus continued hydroxyurea were observed. Further analyses of RELIEF are underway to evaluate what factors may have contributed to a symptom control rate for patients on stable doses of hydroxyurea that was significantly higher than that seen in the best available therapy control arm of the RESPONSE trial, and which led to an underpowering of the RELIEF trial. Data from RELIEF are expected to be presented at an upcoming scientific meeting.
In
Solid Tumors
Full results from RECAP, a Phase II trial of ruxolitinib in combination with capecitabine in patients with metastatic pancreatic cancer, were presented in an oral session at
JANUS 1, a double-blind, placebo-controlled Phase III trial for advanced or metastatic pancreatic cancer, which is being conducted under an SPA, was initiated in
The
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 patients with high levels of systemic inflammation are also recruiting patients.
INCB39110 – a JAK1 Inhibitor
The clinical program to evaluate INCB39110, a selective JAK1 inhibitor, in solid tumors is now underway and will begin with two randomized, double-blind Phase II trials in non-small cell lung cancer. The first trial, in combination with docetaxel, is now recruiting patients and the second trial is planned to open later this year. Both trials will only include patients with high levels of systemic inflammation, with overall survival as a primary endpoint in each.
INCB24360 – an IDO1 Inhibitor
The Company believes that the optimal development strategy for its IDO1 inhibitor INCB24360 is in combination with other immuno-oncology agents, and a Phase I/II trial to evaluate the combination of INCB24360 and Merck’s investigational anti-PD-1 immunotherapy, pembrolizumab (MK-3475), has been initiated. This trial is recruiting patients with previously treated metastatic and recurrent non-small cell lung cancer and other advanced or metastatic cancers.
During the second-quarter of 2014, two additional clinical collaboration agreements were signed to evaluate INCB24360 in combination with investigational checkpoint inhibitors. A Phase I/II trial of INCB24360 in combination with
In
INCB24360 is currently being evaluated in a Phase I/II trial in combination with ipilimumab for metastatic melanoma. Preliminary data from this trial were presented as part of a poster discussion at
INCB40093 – a PI3K-delta Inhibitor
INCB40093 has completed a Phase I monotherapy dose-escalation trial in patients with B-lymphoid malignancies, and the study has proceeded into the dose-expansion phase. A second trial, which started in
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, with the first of four Phase III studies due to complete later in 2014.
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.
About
About Jakafi® (ruxolitinib)
Jakafi is a prescription medicine approved by the
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. 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.
Please see the Full Prescribing Information available at www.incyte.com, which includes a more complete discussion of the risks associated with Jakafi.
Forward-Looking Statements
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; the Company’s view of its regulatory and clinical advances and its scientific and commercial progress; the Company’s plans and expectations with respect to Jakafi® (ruxolitinib), including its potential efficacy and therapeutic and commercial value; the Company’s expectation to present the data from the RELIEF trial at an upcoming scientific meeting;
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 analyses of trial results, 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
INCYTE CORPORATION | ||||||||||||
Condensed Consolidated Statements of Operations | ||||||||||||
(unaudited, in thousands, except per share amounts) |
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Three Months Ended | Six Months Ended | |||||||||||
June 30, |
June 30, |
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2014 | 2013 | 2014 | 2013 | |||||||||
Revenues: | ||||||||||||
Product revenues, net | $ | 84,025 | $ | 54,099 | $ | 153,676 | $ | 102,388 | ||||
Product royalty revenues | 12,340 | 5,800 | 22,166 | 11,709 | ||||||||
Contract revenues | 3,214 | 41,737 | 13,429 | 58,474 | ||||||||
Other revenues | 3 | 39 | 103 | 181 | ||||||||
Total revenues | 99,582 | 101,675 | 189,374 | 172,752 | ||||||||
Costs and expenses: | ||||||||||||
Cost of product revenues | 187 | 157 | 355 | 308 | ||||||||
Research and development | 84,683 | 60,950 | 160,269 | 113,713 | ||||||||
Selling, general and administrative | 40,899 | 23,249 | 77,873 | 45,509 | ||||||||
Total costs and expenses | 125,769 | 84,356 | 238,497 | 159,530 | ||||||||
Income (loss) from operations | (26,187) | 17,319 | (49,123) | 13,222 | ||||||||
Interest and other income, net | 790 | 245 | 1,526 | 444 | ||||||||
Interest expense | (11,406) | (10,293) | (22,849) | (22,022) | ||||||||
Debt exchange expense | - | (9,771) | (265) | (9,771) | ||||||||
Loss before income taxes | (36,803) | (2,500) | (70,711) | (18,127) | ||||||||
Provision for income taxes | 70 | 71 | 119 | 113 | ||||||||
Net loss | $ | (36,873) | $ | (2,571) | $ | (70,830) | $ | (18,240) | ||||
Net loss per basic and diluted share | $ | (0.22) | $ | ( 0.02) | $ | (0.43) | $ | (0.13) | ||||
Shares used in computing basic and diluted net loss per share | 167,914 | 142,284 | 166,636 | 138,315 |
INCYTE CORPORATION | ||||
Condensed Consolidated Balance Sheet Data | ||||
(in thousands) |
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June 30, | December 31, | |||
2014 |
2013 |
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(unaudited) | ||||
Cash, cash equivalents, and short-term marketable securities | 508,753 | 509,004 | ||
Accounts receivable, net | 47,205 | 35,374 | ||
Total assets | 679,107 | 629,568 | ||
Convertible senior notes(1) | 673,315 | 661,567 | ||
Total stockholders’ deficit | (170,998) | (193,108) | ||
(1) Net of unamortized debt discount of
Source:
Incyte Corporation
Pamela M. Murphy
Vice President, Investor Relations & Corporate Communications
302-498-6944