Incyte Reports 2016 First-Quarter Financial Results and Updates Shareholders on Key Clinical Programs
$183 million of 2016 first-quarter net product revenues from Jakafi® (ruxolitinib), representing 59 percent growth over the same period last year. Full year Jakafi net product revenue guidance increased from a range of$800-815 million to a range of$815-830 million .- Recent agreements with Lilly and
Novartis allow development of ruxolitinib for the treatment of graft versus host disease (GVHD); U.S. pivotal trial expected to begin in the second half of 2016. - Expanded European organization via acquisition of ARIAD Pharmaceuticals’ European business
- Diversified and growing portfolio of cancer therapies highlighted in multiple presentations at the AACR annual meeting.
Conference Call and Webcast Scheduled Today at
Incyte’s broad portfolio of development candidates includes immuno-oncology as well as targeted anti-cancer therapies and is made up of both small and large molecules. The recent presentations at the 2016 annual meeting of the
As also announced today,
“Incyte has a unique profile within the biopharmaceutical industry. Our revenue growth and the underlying demand for Jakafi are strong, and we also have the potential for a second important source of revenue should baricitinib be approved in 2017,” stated Hervé Hoppenot, Incyte’s Chief Executive Officer. “We have a fast-moving and rapidly expanding portfolio of exciting development projects, and we also look forward to the initiation of two new pivotal programs – epacadostat for the 1st line treatment of advanced melanoma and ruxolitinib for the treatment of graft versus host disease – during 2016.”
2016 First-Quarter Financial Results
Revenues For the quarter ended
Year Over Year Revenue Growth | ||||||||
(in thousands, unaudited) | ||||||||
Three Months Ended | ||||||||
March 31, | % | |||||||
2016 | 2015 | Change | ||||||
Revenues: | ||||||||
Jakafi net product revenue | $ | 183,267 | $ | 115,330 | 59% | |||
Product royalty revenues | 21,903 | 15,673 | 40% | |||||
Contract revenues | 58,214 | 28,214 | - | |||||
Other revenues | 80 | 58 | - | |||||
Total revenues | $ | 263,464 | $ | 159,275 | ||||
Research and development expenses Research and development expenses for the quarter ended
Selling, general and administrative expenses Selling, general and administrative expenses for the quarter ended
Unrealized loss on long term investment Unrealized loss on long term investment of
Net income / (loss) Net income for the quarter ended
Cash, cash equivalents and marketable securities position As of
2016 Financial Guidance
The Company has updated its full year 2016 financial guidance, as detailed below.
Incyte |
ARIAD EU |
Combined |
||||
Jakafi net product revenues |
$815-$830 million (previously $800-$815 million) |
- | $815-$830 million | |||
Iclusig net product revenues |
- | $25-$30 million | $25-$30 million | |||
Research and development expenses |
$620-$640 million (no change) |
$15-$20 million | $635-$660 million | |||
Selling, general and administrative expenses |
$255-$275 million (previously $255-$270 million) |
$30-$35 million | $285-$310 million |
Corporate Update
In
Portfolio Update
Targeted Cancer Therapies
In April, preliminary data from an open-label Phase 1 dose escalation trial of INCB50465, Incyte’s second-generation, highly selective PI3K delta inhibitor, was presented at AACR 2016. INCB50465 showed promising efficacy in B-cell malignancies and was generally well tolerated at all doses tested.
Indication | Status Update | |||
INCB50465 (PI3Kδ) | B-cell malignancies | Phase 1/2 as monotherapy and in combination with INCB39110 (JAK1); expansion cohorts initiating | ||
INCB39110 (JAK1) | Lung cancer | Phase 1/2 in combination with osimertinib (EGFR) expected to initiate mid-year 2016 | ||
INCB52793 (JAK1) | Advanced malignancies | Phase 1/2 dose-escalation | ||
Capmatinib (c-MET, licensed to Novartis) | Non-small cell lung cancer, glioblastoma, liver cancer | Phase 2 in EGFR wild-type ALK negative NSCLC patients with c-MET amplification and mutation | ||
INCB54828 (FGFR) | Advanced malignancies | Phase 1/2 dose escalation; expansion cohorts in genetically-defined tumor types now underway | ||
INCB54329 (BRD) | Advanced malignancies | Phase 1/2 dose-escalation | ||
INCB53914 (PIM) | Advanced malignancies | Phase 1/2 dose-escalation | ||
INCB59872 (LSD1) | Acute myeloid leukemia, small cell lung cancer | Phase 1/2 dose-escalation |
Immune Cancer Therapies
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. The trial, randomized, double-blind and placebo controlled, is planned to enroll 600 patients and to have dual-primary endpoints of overall survival and progression-free survival. Updated data from the dose-escalation portion of ECHO-202, initial data from which was presented at
Driven by preclinical data presented at the AACR annual meeting in 2015,
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) | |||
INCSHR1210 (PD-1, licensed from Hengrui) |
Solid tumors | Phase 1/2 dose-escalation | ||
INCAGN1876 (GITR, co-developed with Agenus) |
Solid tumors | Phase 1/2 expected to initiate in the first half of 2016 | ||
INCAGN1949 (OX40, co-developed with Agenus) |
Solid tumors | Phase 1/2 expected to initiate in the second half of 2016 | ||
PD-1 platform study | Solid tumors | Phase 1/2, pembrolizumab (PD-1) in combination with INCB39110 (JAK1) or INCB50465 (PI3Kδ) | ||
JAK1 platform study | Solid tumors | Phase 1/2, INCB39110 (JAK1) in combination with epacadostat (IDO1) or INCB50465 (PI3Kδ) |
Non Oncology
During the first quarter of 2016,
Indication | Status Update | |||
Baricitinib (JAK1/JAK2, licensed to Lilly) | Rheumatoid arthritis | NDA & MAA submitted | ||
Psoriasis | Phase 2 studies completed | |||
Atopic dermatitis, systemic lupus erythematosus | Phase 2 | |||
Ruxolitinib (JAK1/JAK2) | Graft versus host disease | Phase 3 to begin in the second half of 2016 | ||
INCB39110 (JAK1) | Graft versus host disease | Phase 1/2 | ||
Topical ruxolitinib (JAK1/JAK2) | Alopecia areata | Phase 2 |
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 in the Investors section under “Events and Presentations”.
About
Follow @
About Jakafi® (ruxolitinib)
Jakafi is a first-in-class JAK1/JAK2 inhibitor approved by the
Jakafi is marketed by
Full Prescribing Information, including a more complete discussion of the risks associated with Jakafi, is available at www.jakafi.com.
About Iclusig® (ponatinib) tablets
Iclusig is a kinase inhibitor. The primary target for Iclusig is BCR-ABL, an abnormal tyrosine kinase that is expressed in chronic myeloid leukemia (CML) and
Iclusig is approved in the U.S., EU, Australia, Switzerland, Israel and Canada.
In the EU, Iclusig is approved for the treatment of adult patients with chronic phase, accelerated phase or blast phase chronic myeloid leukemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation, or the treatment of adult patients with
Click here to view the Iclusig EU Summary of Medicinal Product Characteristics. Click here to view the
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 revised financial guidance for 2016 and the expectations underlying such guidance, including guidance relating to the effect of the planned transactions with ARIAD; whether and when the planned acquisition of ARIAD’s European operations and of the rights for Iclusig will close; whether and when this planned acquisition will effectively advance Incyte’s European organization, maximize any future European product launches or be accretive to Incyte’s earnings; whether and when any of Incyte’s product candidates will be approved 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; market competition; further research and development; sales, marketing and distribution requirements; clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; closing the planned acquisition of ARIAD’s European operations; 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; the Company's dependence on its relationships with its collaboration partners; greater than expected expenses; expenses relating to litigation or strategic activities; our ability to obtain additional capital when needed; obtaining and maintaining effective patent coverage for the Company’s 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 | ||||||||
March 31, | ||||||||
2016 | 2015 | |||||||
Revenues: | ||||||||
Product revenues, net | $ | 183,267 | $ | 115,330 | ||||
Product royalty revenues | 21,903 | 15,673 | ||||||
Contract revenues | 58,214 | 28,214 | ||||||
Other revenues | 80 | 58 | ||||||
Total revenues | 263,464 | 159,275 | ||||||
Costs and expenses: | ||||||||
Cost of product revenues | 6,005 | 2,974 | ||||||
Research and development | 156,824 | 118,365 | ||||||
Selling, general and administrative | 64,596 | 44,871 | ||||||
Total costs and expenses | 227,425 | 166,210 | ||||||
Income (loss) from operations | 36,039 | (6,935) | ||||||
Interest and other income, net | 1,492 | 1,630 | ||||||
Interest expense | (10,134) | (12,687) | ||||||
Unrealized loss on long term investment | (2,950) | - | ||||||
Income (loss) before provision for income taxes | 24,447 | (17,992) | ||||||
Provision for income taxes | 400 | 367 | ||||||
Net income (loss) | $ | 24,047 | $ | (18,359) | ||||
Net income (loss) per share: | ||||||||
Basic | $ | 0.13 | $ | (0.11) | ||||
Diluted | $ | 0.12 | $ | (0.11) | ||||
Shares used in computing net income (loss) per share: | ||||||||
Basic | 187,184 | 172,070 | ||||||
Diluted | 192,625 | 172,070 | ||||||
INCYTE CORPORATION | ||||||
CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||
(unaudited, in thousands) | ||||||
March 31, | December 31, | |||||
2016 | 2015 | |||||
ASSETS | ||||||
Cash, cash equivalents and marketable securities | $ | 810,669 | $ | 707,783 | ||
Restricted cash and investments | 14,383 | 14,493 | ||||
Accounts receivable | 101,280 | 114,450 | ||||
Property and equipment, net | 92,622 | 86,006 | ||||
Inventory | 18,586 | 19,338 | ||||
Prepaid expenses and other assets | 34,104 | 30,122 | ||||
Long term investment | 32,298 | 35,248 | ||||
Total assets | $ | 1,103,942 | $ | 1,007,440 | ||
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||
Accounts payable, accrued expenses and other liabilities | $ | 239,255 | $ | 203,880 | ||
Deferred revenue—collaborative agreements | 9,297 | 12,512 | ||||
Convertible senior notes | 627,642 | 619,893 | ||||
Stockholders’ equity | 227,748 | 171,155 | ||||
Total liabilities and stockholders’ equity | $ | 1,103,942 | $ | 1,007,440 | ||
View source version on businesswire.com: http://www.businesswire.com/news/home/20160509005419/en/
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