Incyte Reports 2015 Fourth-Quarter and Year-End Financial Results, Provides 2016 Financial Guidance and Updates Shareholders on Key Clinical Programs
$182 million of 2015 fourth-quarter net product revenues from Jakafi® (ruxolitinib), representing 72 percent growth over the same period last year and$601 million of 2015 full-year net product revenues from Jakafi, representing 68 percent growth over last year- 2016 guidance for Jakafi net product revenues in the range of
$800 million to $815 million , reflecting expectations for continued growth in underlying demand in myelofibrosis (MF) and an increasing contribution from the ongoing launch in polycythemia vera (PV) - Broad and diverse portfolio with 13 development molecules being investigated as monotherapy and in combination across multiple indications
Conference Call and Webcast Scheduled Today at
Incyte’s strong position in the field of JAK inhibition is demonstrated by the ongoing commercial success of Jakafi and by the recent submissions, by
“The momentum of Jakafi, now into its fifth year of commercialization, continues to be strong, and, pending regulatory approval, we look forward to a second important source of revenue from baricitinib,” stated Hervé Hoppenot, Incyte’s President and Chief Executive Officer. “Despite the outcome of the JANUS program, our development portfolio remains robust, comprised of 13 candidates against 10 molecular targets, demonstrating Incyte’s commitment to innovation and the productivity of our drug discovery and development engine.”
2015 Fourth-Quarter and Full-Year Financial Results
Revenues For the quarter ended
Year Over Year Revenue Growth | ||||||||||||||||||
(in thousands, unaudited) | ||||||||||||||||||
Three Months Ended | Twelve Months Ended | |||||||||||||||||
December 31, | % | December 31, | % | |||||||||||||||
2015 | 2014 | Change | 2015 | 2014 | Change | |||||||||||||
Revenues: | ||||||||||||||||||
Jakafi net product revenue | $ | 182,021 | $ | 106,049 | 72% | $ | 601,015 | $ | 357,562 | 68% | ||||||||
Product royalty revenues | 23,646 | 14,707 | 61% | 74,821 | 48,966 | 53% | ||||||||||||
Contract and other revenues | 38,214 | 3,217 | - | 77,915 | 104,967 | - | ||||||||||||
Total revenues | $ | 243,881 | $ | 123,973 | $ | 753,751 | $ | 511,495 | ||||||||||
Research and development expenses Research and development expenses for the quarter and full year ended
Selling, general and administrative expenses Selling, general and administrative expenses for the quarter and full year ended
Unrealized loss on long term investment Unrealized loss on long term investment of $0 million and
Net income / (loss) Net income for the quarter ended
Cash, cash equivalents and marketable securities position As of
2016 Financial Guidance
The Company has provided full year 2016 financial guidance, as detailed below.
Guidance | ||
Jakafi net product revenues | $800-$815 million | |
Research and development expenses | $620-$640 million, including a non-cash expense of approximately $55-$60 million related to the impact of employee equity awards | |
Selling, general and administrative expenses | $255-$270 million, including a non-cash expense of approximately $30-$35 million related to the impact of employee equity awards | |
Portfolio Update
JAK Inhibitors
A New Drug Application (NDA) and a Marketing Authorization Application (MAA) have been submitted by Lilly to the
As previously announced, the clinical development program investigating the hypothesis that JAK inhibition may benefit patients with solid tumors and high levels of systemic inflammation has been discontinued. All commercial activities with Jakafi, and all investigational activities of JAK inhibition outside this hypothesis, are unaffected.
Ongoing studies of ruxolitinib and selective JAK1 inhibitors in hematology indications will continue. Ongoing studies of selective JAK1 inhibition in solid tumor indications that are based on different hypotheses will also continue. These include a series of combination studies evaluating INCB39110, a selective JAK1 inhibitor, with either pembrolizumab (anti-PD-1 antibody), epacadostat (Incyte’s IDO1 inhibitor), or INCB50465 (Incyte’s PI3Kδ inhibitor) that will assess the therapeutic utility of JAK1 inhibition based on its effects on the tumor microenvironment. Additionally, the potential for JAK1 inhibition to improve the benefit of targeted therapies will be investigated via a Phase 1/2 study of INCB39110 plus osimertinib, AstraZeneca’s next generation EGFR inhibitor.
INCB39110 is also in a proof-of-concept trial for the treatment of patients with graft versus host disease.
Incyte’s second selective JAK1 inhibitor, INCB52793, is in a dose escalation study in patients with advanced malignancies. INCB52793 has shown synergistic efficacy in combination with standard of care in preclinical models of multiple myeloma.
Indication | Status Update | |||
Baricitinib (JAK1/JAK2, licensed to Lilly) |
Rheumatoid arthritis | NDA & MAA submitted | ||
Psoriasis, diabetic nephropathy | Phase 2 studies completed | |||
Atopic dermatitis | Phase 2 | |||
Topical ruxolitinib (JAK1/JAK2)1 |
Alopecia areata | Phase 2 | ||
INCB39110 (JAK1) | Lung cancer | Phase 1/2 in combination with osimertinib (EGFR) expected to initiate mid-year 2016 | ||
Advanced malignancies | Phase 1/2 in combination with pembrolizumab (PD-1), epacadostat (IDO1), or INCB50465 (PI3Kδ) | |||
Graft versus host disease | Phase 2 | |||
INCB52793 (JAK1) | Advanced malignancies | Phase 1/2 |
1 |
The Collaboration and License Agreement with Novartis for ruxolitinib ex-U.S. does not include topical administration. | |
IDO1 Inhibitor
The ECHO (Epacadostat Clinical development in Hematology and Oncology) program has been designed to investigate combinations of Incyte’s IDO1 inhibitor, epacadostat, across the full cycle of anti-tumor immunity, including with checkpoint blockade, vaccines and other modulators of the tumor immune response.
The Phase 3 ECHO-301 study evaluating the combination of epacadostat with the anti-PD-1 antibody pembrolizumab for the first-line treatment of patients with advanced or metastatic melanoma is expected to begin in the first half of 2016.
During 2016,
Indication | Status Update | |||
Epacadostat | First line, advanced melanoma | Phase 3 (ECHO-301) expected to begin in the first half of 2016 in combination with pembrolizumab (PD-1) | ||
Multiple tumor types | Phase 2 (ECHO-202) expansion cohorts now recruiting in combination with pembrolizumab (PD-1) | |||
Multiple tumor types | Phase 2 (ECHO-204) expansion cohorts now recruiting in combination with nivolumab (PD-1) | |||
Multiple tumor types | Phase 2 (ECHO-203) expansion cohorts now recruiting in combination with durvalumab (PD-L1) | |||
Non-small cell lung cancer | Phase 1/2 (ECHO-110) dose-escalation ongoing in combination with atezolizumab (PD-L1) | |||
Additional Programs
With two of our new programs expected to enter the clinic in the coming months,
Indication | Status Update | |||
INCB50465 (PI3Kδ) | B-cell malignancies | Phase 1/2 as monotherapy and in combination with INCB39110 (JAK1); expansion cohorts initiating | ||
Solid tumors | Phase 1/2 in combination with pembrolizumab (PD-1), epacadostat (IDO1), or INCB39110 (JAK1) | |||
Capmatinib (c-MET, licensed to Novartis) |
Non-small cell lung cancer, glioblastoma, liver cancer | Phase 2 in patients with c-MET amplification | ||
INCB54828 (FGFR) | Solid tumors | Phase 1/2 dose escalation; expansion cohorts in genetically-defined tumor types expected in 2016 | ||
INCB54329 (BRD) | Advanced malignancies | Phase 1/2 dose-escalation | ||
INCB53914 (PIM) | Advanced malignancies | Phase 1/2 dose-escalation | ||
INCSHR1210 (PD-1, licensed from Hengrui) |
Solid tumors | Phase 1/2 dose-escalation | ||
INCB59872 (LSD1) | Advanced malignancies | Phase 1/2 expected to initiate in the first half of 2016 | ||
INCAGN1876 (GITR, co-developed with Agenus) |
Advanced malignancies | Phase 1/2 expected to initiate in the first half of 2016 | ||
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 2016 and the expectations underlying such guidance; whether and when the Company will receive earned and future potential regulatory milestone payments or royalty payments from Lilly with respect to baricitinib, whether baricitinib will be approved in the U.S. or receive a positive opinion in
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 and risks associated with 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 or warrant continued development, 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, greater than expected expenses, unanticipated or unpredictable expenses relating to litigation or strategic activities, our ability to obtain additional capital when needed, risks related to obtaining effective patent coverage for our products 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 | Twelve Months Ended | |||||||||||||||
December 31, | December 31, | |||||||||||||||
2015 | 2014 | 2015 | 2014 | |||||||||||||
Revenues: | ||||||||||||||||
Product revenues, net | $ | 182,021 | $ | 106,049 | $ | 601,015 | $ | 357,562 | ||||||||
Product royalty revenues | 23,646 | 14,707 | 74,821 | 48,966 | ||||||||||||
Contract revenues | 38,214 | 3,214 | 77,857 | 104,857 | ||||||||||||
Other revenues | - | 3 | 58 | 110 | ||||||||||||
Total revenues | 243,881 | 123,973 | 753,751 | 511,495 | ||||||||||||
Costs and expenses: | ||||||||||||||||
Cost of product revenues | 9,704 | 2,428 | 26,972 | 3,004 | ||||||||||||
Research and development | 116,630 | 98,717 | 479,514 | 347,523 | ||||||||||||
Selling, general and administrative | 52,467 | 48,452 | 196,614 | 165,772 | ||||||||||||
Total costs and expenses | 178,801 | 149,597 | 703,100 | 516,299 | ||||||||||||
Income (loss) from operations | 65,080 | (25,624) | 50,651 | (4,804) | ||||||||||||
Interest and other income, net | 1,289 | 940 | 7,089 | 3,350 | ||||||||||||
Interest expense | (10,213) | (12,516) | (45,603) | (46,828) | ||||||||||||
Unrealized loss on long term investment | (466) | - | (4,581) | - | ||||||||||||
Debt exchange expense on senior note conversions |
- | - | - | (265) | ||||||||||||
Income (loss) before provision for income taxes |
55,690 | (37,200) | 7,556 | (48,547) | ||||||||||||
Provision (benefit) for income taxes | 512 | (256) | 1,025 | (66) | ||||||||||||
Net income (loss) | $ | 55,178 | $ | (36,944 | $ | 6,531 | $ | (48,481 | ||||||||
Net income (loss) per share: | ||||||||||||||||
Basic | $ | 0.30 | $ | (0.22) | $ | 0.04 | $ | (0.29) | ||||||||
Diluted | $ | 0.29 | $ | (0.22) | $ | 0.03 | $ | (0.29) | ||||||||
Shares used in computing net income (loss) per share: |
||||||||||||||||
Basic | 186,269 | 169,924 | 179,601 | 167,947 | ||||||||||||
Diluted | 193,367 | 169,924 | 187,302 | 167,947 |
INCYTE CORPORATION | ||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
(unaudited, in thousands) | ||||||||
December 31, | December 31, | |||||||
2015 | 2014 | |||||||
ASSETS | ||||||||
Cash, cash equivalents and marketable securities | $ | 707,783 | $ | 600,263 | ||||
Restricted cash and investments | 14,493 | 14,500 | ||||||
Accounts receivable | 114,450 | 57,933 | ||||||
Property and equipment, net | 86,006 | 81,790 | ||||||
Inventory | 19,338 | 19,436 | ||||||
Prepaid expenses and other assets | 30,122 | 22,555 | ||||||
Long term investment | 35,248 | - | ||||||
Total assets | $ | 1,007,440 | $ | 796,477 | ||||
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | ||||||||
Accounts payable, accrued expenses and other liabilities | $ | 203,880 | $ | 177,547 | ||||
Deferred revenue—collaborative agreements | 12,512 | 25,391 | ||||||
Convertible senior notes | 619,893 | 675,167 | ||||||
Stockholders’ equity (deficit) | 171,155 | (81,628) | ||||||
Total liabilities and stockholders’ equity (deficit) | $ | 1,007,440 | $ | 796,477 |
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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