Incyte Reports 2015 Second-Quarter Financial Results and Updates Shareholders on Key Clinical Programs
$142 million of 2015 second-quarter net product revenues from Jakafi® (ruxolitinib), representing 69 percent growth over the same period last year- 2015 guidance for Jakafi net product revenues increased to range of
$560 million to $575 million , driven by strong underlying demand - Positive results from two pivotal trials of baricitinib in rheumatoid arthritis presented at EULAR
- Multiple abstracts presented at
ASCO and EHA, demonstrating continued progress across broad clinical portfolio
Conference Call and Webcast Scheduled Today at
The Company highlighted the continued momentum in the commercialization of Jakafi in the U.S., as well as progress being made across its clinical portfolio, including the results of two pivotal trials of baricitinib that were presented with
“The commercial performance of Jakafi in Q2 2015 was very strong, confirming both underlying growth from the myelofibrosis indication and an acceleration in Jakafi growth from the launch in patients with uncontrolled polycythemia vera,” stated Hervé Hoppenot, Incyte’s President and Chief Executive Officer. “Recent data presented from our product candidates, and the progress we are making in recruiting multiple clinical trials, further illustrate the strength and diversity of our development portfolio.”
Jakafi is approved by the
2015 Second-Quarter Financial Results
Revenues For the quarter ended
Year Over Year Revenue Growth | ||||||||||||||||||
(in thousands, unaudited) | ||||||||||||||||||
Three Months Ended | Six Months Ended | |||||||||||||||||
June 30, | % | June 30, | % | |||||||||||||||
2015 | 2014 | Change | 2015 | 2014 | Change | |||||||||||||
Revenues: | ||||||||||||||||||
Jakafi net product revenue | $142,406 | $ 84,025 | 69% | $257,736 | $153,676 | 68% | ||||||||||||
Product royalty revenues | 17,364 | 12,340 | 41% | 33,037 | 22,166 | 49% | ||||||||||||
Contract revenues | 3,214 | 3,214 | - | 31,429 | 13,429 | - | ||||||||||||
Other revenues | - | 3 | - | 58 | 103 | - | ||||||||||||
Total revenues | $162,984 | $ 99,582 | $322,260 | $189,374 | ||||||||||||||
Research and development expenses Research and development expenses for the quarter and six months ended
Selling, general and administrative expenses Selling, general and administrative expenses for the quarter and six months ended
Unrealized gain on long term investment Unrealized gain on long term investment of
Net income / (loss) Net income 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 | $525-$565 million | $560-$575 million | ||
Research and development expenses | $450-$500 million, includes non-cash stock compensation expense of $40-$45 million | $475-$500 million, includes non-cash stock compensation expense of $40-$45 million | ||
Selling, general and administrative expenses | $180-200 million, includes non-cash stock compensation expense of $30-$35 million | $195-$210 million, includes non-cash compensation expense of $30-$35 million | ||
Product Update
Jakafi (ruxolitinib) – JAK1 and JAK2 Inhibitor
Follow-up results from the pivotal RESPONSE trial of ruxolitinib in patients with uncontrolled polycythemia vera were presented at the 2015
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.
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),
INCB39110 & INCB52793 – JAK1-Selective Inhibitors
In
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
Initial results of the combination of INCB40093 and the JAK1-selective inhibitor INCB39110 in B-cell malignancies were presented at the 2015
INCB50465 is a highly-potent PI3Kδ inhibitor, and an open-label, dose-escalation study of INCB50465 in subjects with previously treated B-cell malignancies has been initiated.
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
In the second quarter of 2015, the Company initiated an open-label, dose-escalation study of INCB54329 in subjects with advanced 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
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; the Company’s emerging development pipeline and the timing and potential success of any of those studies; and the Company’s expectation to disclose, with Lilly, the results from other ongoing Phase III studies evaluating baricitinib in rheumatoid arthritis in 2015.
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 | Six Months Ended | |||||||||||||||||||
June 30, | June 30, | |||||||||||||||||||
2015 | 2014 | 2015 | 2014 | |||||||||||||||||
Revenues: | ||||||||||||||||||||
Product revenues, net | $ | 142,406 | $ | 84,025 | $ | 257,736 | $ | 153,676 | ||||||||||||
Product royalty revenues | 17,364 | 12,340 | 33,037 | 22,166 | ||||||||||||||||
Contract revenues | 3,214 | 3,214 | 31,429 | 13,429 | ||||||||||||||||
Other revenues | - | 3 | 58 | 103 | ||||||||||||||||
Total revenues | 162,984 | 99,582 | 322,260 | 189,374 | ||||||||||||||||
Costs and expenses: | ||||||||||||||||||||
Cost of product revenues | 6,254 | 187 | 9,229 | 355 | ||||||||||||||||
Research and development | 112,445 | 84,683 | 230,809 | 160,269 | ||||||||||||||||
Selling, general and administrative |
51,679 | 40,899 | 96,548 | 77,873 | ||||||||||||||||
Total costs and expenses | 170,378 | 125,769 | 336,586 | 238,497 | ||||||||||||||||
Loss from operations | (7,394) | (26,187) | (14,326) | (49,123) | ||||||||||||||||
Interest and other income, net | 1,144 | 790 | 2,773 | 1,526 | ||||||||||||||||
Interest expense | (11,494) | (11,406) | (24,181) | (22,849) | ||||||||||||||||
Unrealized gain on long term investment | 27,174 | - | 27,174 | - | ||||||||||||||||
Debt exchange expense on senior note conversions |
- | - | - | (265) | ||||||||||||||||
Income (loss) before provision for income taxes |
9,430 | (36,803) | (8,560) | (70,711) | ||||||||||||||||
Provision for income taxes | 136 | 70 | 503 | 119 | ||||||||||||||||
Net income (loss) | $ | 9,294 | $ | (36,873) | $ | (9,063) | $ | (70,830) | ||||||||||||
Net income (loss) per share: | ||||||||||||||||||||
Basic | $ | 0.05 | $ | (0.22) | $ | (0.05) | $ | (0.43) | ||||||||||||
Diluted | $ | 0.05 | $ | (0.22) | $ | (0.05) | $ | (0.43) | ||||||||||||
|
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Shares used in computing net income (loss) per share: |
||||||||||||||||||||
Basic |
178,676 | 167,914 | 175,373 | 166,636 | ||||||||||||||||
Diluted | 186,493 | 167,914 | 175,373 | 166,636 | ||||||||||||||||
INCYTE CORPORATION | |||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||||
(in thousands) | |||||||||
June 30, | December 31, | ||||||||
2015 (unaudited) | 2014 (audited) | ||||||||
ASSETS | |||||||||
Cash, cash equivalents and marketable securities | $ | 627,469 | $ | 600,263 | |||||
Restricted investments | 14,773 | 14,500 | |||||||
Accounts receivable | 75,122 | 57,933 | |||||||
Property and equipment, net | 81,602 | 81,790 | |||||||
Inventory | 20,445 | 19,436 | |||||||
Prepaid expenses and other assets | 43,923 | 56,147 | |||||||
Long term investment | 67,003 | - | |||||||
Total assets | $ | 930,337 | $ | 830,069 | |||||
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | |||||||||
Accounts payable, accrued expenses and other liabilities | $ | 196,258 | $ | 197,188 | |||||
Deferred revenue—collaborative agreements | 18,940 | 25,391 | |||||||
Convertible senior notes | 659,965 | 689,118 | |||||||
Stockholders’ equity (deficit) | 55,174 | (81,628) | |||||||
Total liabilities and stockholders’ equity (deficit) | $ | 930,337 | $ | 830,069 | |||||
View source version on businesswire.com: http://www.businesswire.com/news/home/20150804005325/en/
Source:
Incyte Corporation
Michael Booth, DPhil
Vice President, Investor Relations
302-498-5914