Incyte Reports 2015 Third-Quarter Financial Results and Updates Shareholders on Key Clinical Programs
- Positive results from two pivotal trials of baricitinib to be highlighted at ACR; baricitinib superior to both methotrexate (RA-BEGIN) and to Humira® (adalimumab) (RA-BEAM) in reducing the signs and symptoms of rheumatoid arthritis
- Agreement announced with Merck to expand clinical collaboration to include a pivotal trial of epacadostat plus pembrolizumab in first-line advanced or metastatic melanoma; proof-of-concept data from the ongoing Phase I/II trial to be presented at
Conference Call and Webcast Scheduled Today at
The Company highlighted the continued strong revenue growth from Jakafi in the U.S. and royalties from sales of Jakavi® (ruxolitinib) outside of the U.S. by the Company’s collaborator,
“We are very pleased with the continued revenue growth from Jakafi during the third quarter, which was driven by strong underlying demand from both of its approved indications,” stated Hervé Hoppenot, Incyte’s President and Chief Executive Officer. “We are successfully executing on our aggressive clinical development plans, and believe that the positive outcome of the pivotal RA development program for baricitinib and the progression of epacadostat into a global Phase III trial are both landmark events as we continue our transformation into a world-leading biopharmaceutical business.”
2015 Third-Quarter Financial Results
Revenues For the quarter ended
Year Over Year Revenue Growth | ||||||||||||||||||
(in thousands, unaudited) | ||||||||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||||||||
September 30, | % | September 30, | % | |||||||||||||||
2015 | 2014 | Change | 2015 | 2014 | Change | |||||||||||||
Revenues: | ||||||||||||||||||
Jakafi net product revenue | $ | 161,259 | $ | 97,837 | 65% | $ | 418,994 | $ | 251,513 | 67% | ||||||||
Product royalty revenues | 18,138 | 12,093 | 50% | 51,175 | 34,259 | 49% | ||||||||||||
Contract revenues | 8,214 | 88,214 | - | 39,643 | 101,643 | - | ||||||||||||
Other revenues | - | 3 | - | 58 | 107 | - | ||||||||||||
Total revenues | $ | 187,611 | $ | 198,147 | $ | 509,870 | $ | 387,522 | ||||||||||
Research and development expenses Research and development expenses for the quarter and nine months ended
Selling, general and administrative expenses Selling, general and administrative expenses for the quarter and nine months ended
Unrealized loss on long term investment Unrealized loss on long term investment of
Net income / (loss) Net loss for the quarter ended
Cash, cash equivalents and marketable securities position As of
2015 Financial Guidance
The Company has updated its full year 2015 financial guidance, as detailed below.
Previous Guidance | Updated Guidance | |||
Jakafi net product revenues | $560-$575 million | $580-$590 million | ||
Contract revenue (including milestone revenues) | $58 million | $78 million | ||
Research and development expenses | $475-$500 million, includes non-cash stock compensation expense of $40-$45 million | Unchanged | ||
Selling, general and administrative expenses | $195-$210 million, includes non-cash compensation expense of $30-$35 million | $200-$210 million, includes non-cash compensation expense of $30-$35 million | ||
Product Update
Jakafi (ruxolitinib) – JAK1 and JAK2 Inhibitor
The pivotal Phase III JANUS 1 and JANUS 2 studies of ruxolitinib in second line metastatic pancreatic cancer are ongoing. Three Phase II trials of ruxolitinib are ongoing in colorectal, breast and non-small cell lung cancer (NSCLC) patients.
A Phase II trial of topical ruxolitinib cream has begun in patients with alopecia areata, the primary endpoint of which is the percentage of subjects achieving a Severity of Alopecia Tool score (SALT) 50 response in terminal hair (pigmented and non-pigmented) at 24 weeks.
baricitinib – JAK1 and JAK2 Inhibitor
In
In
epacadostat (INCB24360) – IDO1 Inhibitor
Four clinical trials to evaluate epacadostat in combination with immune checkpoint inhibitors are all recruiting patients. These trials are evaluating epacadostat in combination with Merck & Co’s PD-1 inhibitor Keytruda® (pembrolizumab)*,
Initial proof-of-concept results from the combination trial of epacadostat and pembrolizumab are expected to be presented at the upcoming
In
INCB39110 & INCB52793 – JAK1-Selective Inhibitors
INCB39110, in combination with INCB40093, Incyte’s PI3Kδ inhibitor, is in development for patients with B-cell malignancies. INCB39110 is also in a Phase II trial, in combination with gemcitabine and nab-paclitaxel, in patients with pancreatic cancer.
The Company’s second JAK1-selective inhibitor, INCB52793, is in a Phase I/II monotherapy dose-escalation trial in advanced malignancies.
INCB40093 & INCB50465 – PI3Kδ Inhibitors
INCB40093 is in clinical development in combination with the JAK1-selective inhibitor INCB39110 in B-cell malignancies. An open-label, dose-escalation monotherapy study of INCB50465 in subjects with previously treated B-cell malignancies is underway.
capmatinib (INC280) – c-MET Inhibitor
Capmatinib is being investigated by
INCB54828 – FGFR Inhibitor
INCB54828 is in an open-label, dose-escalation study in subjects with advanced malignancies.
INCB54329 – BRD Inhibitor
INCB54329 is in an open-label, dose-escalation study in subjects with advanced malignancies.
INCSHR1210 – PD-1 inhibitor
During the third quarter of 2015,
INCB53914 – PIM Inhibitor
The Company has initiated an open-label, dose-escalation study of INCB53914, a selective pan-PIM kinase inhibitor, in subjects with hematological malignancies.
Conference Call and Webcast 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 first-in-class JAK1/JAK2 inhibitor approved by the
Jakafi is marketed by
* The brand listed is not a trademark of
Forward-Looking Statements
Except for the historical information set forth herein, the matters set forth in this press release contain predictions, estimates and other forward-looking statements, including without limitation statements regarding: the Company’s financial guidance for 2015; its continued transformation into a world-leading biopharmaceutical business; and the Company’s emerging development pipeline and the timing and potential success of any of those studies as well as the Company’s and, where applicable, its and its collaborators’ plans to announce data from any of those studies.
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
INCYTE CORPORATION | |||||||||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||||||
(unaudited, in thousands, except per share amounts) | |||||||||||||||||||
Three Months Ended | Nine Months Ended | ||||||||||||||||||
September 30, | September 30, | ||||||||||||||||||
2015 |
|
2014 | 2015 | 2014 | |||||||||||||||
Revenues: | |||||||||||||||||||
Product revenues, net | $ | 161,259 | $ | 97,837 | $ | 418,994 | $ | 251,513 | |||||||||||
Product royalty revenues | 18,138 | 12,093 | 51,175 | 34,259 | |||||||||||||||
Contract revenues | 8,214 | 88,214 | 39,643 | 101,643 | |||||||||||||||
Other revenues | - | 3 | 58 | 107 | |||||||||||||||
Total revenues | 187,611 | 198,147 | 509,870 | 387,522 | |||||||||||||||
Costs and expenses: | |||||||||||||||||||
Cost of product revenues | 8,040 | 221 | 17,268 | 576 | |||||||||||||||
Research and development | 132,073 | 88,537 | 362,882 | 248,806 | |||||||||||||||
Selling, general and administrative |
47,599 | 39,446 | 144,147 | 117,320 | |||||||||||||||
Total costs and expenses | 187,712 | 128,204 | 524,297 | 366,702 | |||||||||||||||
Income (loss) from operations | (101) | 69,943 | (14,427) | 20,820 | |||||||||||||||
Interest and other income, net | 3,026 | 885 | 5,800 | 2,410 | |||||||||||||||
Interest expense | (11,209) | (11,463) | (35,390) | (34,312) | |||||||||||||||
Unrealized loss on long term investment | (31,289) | - | (4,115) | - | |||||||||||||||
Debt exchange expense on senior note conversions |
- | - | - | (265) | |||||||||||||||
Income (loss) before provision for income taxes |
(39,573) | 59,365 | (48,132) | (11,347) | |||||||||||||||
Provision for income taxes | 9 | 72 | 513 | 191 | |||||||||||||||
Net income (loss) | $ | (39,582) | $ | 59,293 | $ | (48,645) | $ | (11,538) | |||||||||||
Net income (loss) per share: | |||||||||||||||||||
Basic | $ | (0.22) | $ | 0.35 | $ | (0.27) | $ | (0.07) | |||||||||||
Diluted | $ | (0.22) | $ | 0.33 | $ | (0.27) | $ | (0.07) | |||||||||||
Shares used in computing net income (loss) per share: |
|||||||||||||||||||
Basic | 181,387 | 168,592 | 177,378 | 167,288 | |||||||||||||||
Diluted | 181,387 | 189,046 | 177,378 | 167,288 | |||||||||||||||
INCYTE CORPORATION | |||||||
CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||
(in thousands) | |||||||
September 30, | December 31, | ||||||
2015 | 2014 | ||||||
(unaudited) | (audited) | ||||||
ASSETS | |||||||
Cash, cash equivalents and marketable securities | $ | 635,045 | $ | 600,263 | |||
Restricted cash and investments | 18,628 | 14,500 | |||||
Accounts receivable | 86,966 | 57,933 | |||||
Property and equipment, net | 83,186 | 81,790 | |||||
Inventory | 20,266 | 19,436 | |||||
Prepaid expenses and other assets | 52,127 | 56,147 | |||||
Long term investment | 35,714 | - | |||||
Total assets | $ | 931,932 | $ | 830,069 | |||
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | |||||||
Accounts payable, accrued expenses and other liabilities | $ | 203,536 | $ | 197,188 | |||
Deferred revenue—collaborative agreements | 15,726 | 25,391 | |||||
Convertible senior notes | 623,933 | 689,118 | |||||
Stockholders’ equity (deficit) | 88,737 | (81,628) | |||||
Total liabilities and stockholders’ equity (deficit) | $ | 931,932 | $ | 830,069 | |||
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Source:
Incyte Corporation
Media
Catalina Loveman, +1 302-498-6171
cloveman@incyte.com
or
Investors
Michael Booth, DPhil, +1 302-498-5914
mbooth@incyte.com