Incyte Reports 2016 Second-Quarter Financial Results and Updates Key Clinical Programs
$208 million of 2016 second-quarter net product revenues from Jakafi® (ruxolitinib), representing 46 percent growth over the same period last year- ECHO-301, the first Phase 3 trial evaluating epacadostat, now underway in combination with pembrolizumab as first-line treatment of patients with advanced or metastatic melanoma
- New Phase 3 clinical data from COMFORT-I in myelofibrosis and RESPONSE-2 in polycythemia vera reinforce the leadership position of Jakafi in the treatment of patients with these myeloproliferative neoplasms (MPNs)
- Ruxolitinib granted Breakthrough Therapy Designation by the
FDA for the treatment of patients with acute graft-versus-host disease (GVHD)
Conference Call and Webcast Scheduled Today at
The long-term clinical profile of Jakafi was reinforced by the presentation of five-year overall survival data from the COMFORT-I trial in patients with myelofibrosis at the recent
Baricitinib, currently under global regulatory review for the treatment of patients with rheumatoid arthritis, may provide
Within the R&D group, and during the second quarter of 2016,
“Incyte is in an excellent position both financially and operationally as we enter the second half of the year,” stated Hervé Hoppenot, Incyte’s Chief Executive Officer. “Jakafi continues to grow rapidly in the U.S., and we have successfully incorporated our expanded European team. The recent initiation of the first Phase 3 trial of epacadostat was a significant milestone for
2016 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, | % | |||||||||||||
2016 | 2015 | Change | 2016 | 2015 | Change | |||||||||||
Revenues: | ||||||||||||||||
Jakafi net product revenue | $ | 208,126 | $ | 142,406 | 46% | $ | 391,393 | $ | 257,736 | 52% | ||||||
Iclusig net product revenue | 3,990 | - | - | 3,990 | - | - | ||||||||||
Product royalty revenues | 25,958 | 17,364 | 49% | 47,860 | 33,037 | 45% | ||||||||||
Contract revenues | 8,214 | 3,214 | - | 66,429 | 31,429 | - | ||||||||||
Other revenues | - | - | - | 80 | 58 | - | ||||||||||
Total revenues | $ | 246,288 | $ | 162,984 | 51% | $ | 509,752 | $ | 322,260 | 58% | ||||||
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 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.
Current | Previous | |||
Jakafi net product revenues | $825-$835 million | $815-$830 million | ||
Iclusig net product revenues | $25-$30 million | Unchanged | ||
Research and development expenses | $620-$630 million | $635-$660 million | ||
Selling, general and administrative expenses | $285-$310 million | Unchanged | ||
Corporate Update
In
Portfolio Update
Cancer – Targeted Therapies
In
A proof-of-concept trial of INCB39110, a selective JAK1 inhibitor, in patients with GVHD has completed recruitment and initial data is expected before the end of 2016.
In
A Phase 2 trial of INCB54828, a selective FGFR inhibitor, in patients with bladder cancer harboring FGFR pathway alterations is expected to start in the second half of 2016.
Indication | Status Update | |||
Ruxolitinib (JAK1/JAK2) | Graft versus host disease | Pivotal program expected to begin in the second half of 2016 | ||
INCB39110 (JAK1) | Graft versus host disease | Phase 1/2 fully recruited, data expected before the end of 2016 | ||
INCB39110 (JAK1) | Lung cancer | Phase 1/2 in combination with osimertinib (EGFR) expected to initiate in the second half of 2016 | ||
INCB52793 (JAK1) | Advanced malignancies | Phase 1/2 dose-escalation | ||
INCB50465 (PI3Kδ) | B-cell malignancies | Phase 1/2 as monotherapy and in combination with INCB39110 (JAK1) | ||
INCB54828 (FGFR) | Bladder cancer | Phase 2 expected to initiate in the second half of 2016 | ||
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 | ||
Cancer – Immune Therapies
The Phase 3 ECHO-301 study evaluating epacadostat in combination with the anti-PD-1 antibody, pembrolizumab, for the first-line treatment of patients with advanced or metastatic melanoma is now recruiting patients. The randomized, double-blind and placebo controlled trial, is planned to enroll 600 patients and to have dual-primary endpoints of progression-free survival and overall survival.
Updated data from the Phase 1 portion of ECHO-202, which was initially presented at
In
Indication | Status Update | |||
Epacadostat | First line, advanced melanoma | Phase 3 (ECHO-301) in combination with pembrolizumab (PD-1) | ||
Multiple tumor types | Phase 2 (ECHO-202) expansion cohorts in combination with pembrolizumab (PD-1) | |||
Multiple tumor types | Phase 2 (ECHO-204) expansion cohorts in combination with nivolumab (PD-1) | |||
Multiple tumor types | Phase 2 (ECHO-203) expansion cohorts in combination with durvalumab (PD-L1) | |||
Non-small cell lung cancer | Phase 1/2 (ECHO-110) dose-escalation 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 dose-escalation | ||
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
In
Indication | Status Update | |||
Topical ruxolitinib (JAK1/JAK2) | Alopecia areata | Phase 2 | ||
Partnered
Baricitinib, a JAK1/JAK2 inhibitor licensed to Lilly, is under global regulatory review for the treatment of patients with rheumatoid arthritis. If approved,
In
Indication | Status Update | |||
Baricitinib (JAK1/JAK2, licensed to Lilly) | Rheumatoid arthritis | NDA & MAA submitted | ||
Atopic dermatitis, systemic lupus erythematosus | Phase 2 | |||
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 | ||
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
About Iclusig® (ponatinib) tablets
Iclusig targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which has been associated with resistance to other approved TKIs.
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
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; whether and when the Company will receive potential 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 our products; the acceptance of our products 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; 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 | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2016 | 2015 | 2016 | 2015 | |||||||||||||
Revenues: | ||||||||||||||||
Product revenues, net | $ | 212,116 | $ | 142,406 | $ | 395,383 | $ | 257,736 | ||||||||
Product royalty revenues | 25,958 | 17,364 | 47,860 | 33,037 | ||||||||||||
Contract revenues | 8,214 | 3,214 | 66,429 | 31,429 | ||||||||||||
Other revenues | - | - | 80 | 58 | ||||||||||||
Total revenues | 246,288 | 162,984 | 509,752 | 322,260 | ||||||||||||
Costs and expenses: | ||||||||||||||||
Cost of product revenues (including definite-lived intangible amortization) | 12,367 | 6,254 | 18,372 | 9,229 | ||||||||||||
Research and development | 120,269 | 112,445 | 277,092 | 230,809 | ||||||||||||
Selling, general and administrative | 66,792 | 51,679 | 131,390 | 96,548 | ||||||||||||
Change in fair value of acquisition-related contingent consideration | 2,271 | - | 2,271 | - | ||||||||||||
Total costs and expenses | 201,699 | 170,378 | 429,125 | 336,586 | ||||||||||||
Income (loss) from operations | 44,589 | (7,394) | 80,627 | (14,326) | ||||||||||||
Interest and other income, net | 1,137 | 1,144 | 2,630 | 2,773 | ||||||||||||
Interest expense | (9,662) | (11,494) | (19,796) | (24,181) | ||||||||||||
Unrealized gain (loss) on long term investment | (854) | 27,174 | (3,804) | 27,174 | ||||||||||||
Income (loss) before provision for income taxes | 35,210 | 9,430 | 59,657 | (8,560) | ||||||||||||
Provision for income taxes | 785 | 136 | 1,185 | 503 | ||||||||||||
Net income (loss) | $ | 34,425 | $ | 9,294 | $ | 58,472 | $ | (9,063) | ||||||||
Net income (loss) per share: | ||||||||||||||||
Basic | $ | 0.18 | $ | 0.05 | $ | 0.31 | $ | (0.05) | ||||||||
Diluted | $ | 0.18 | $ | 0.05 | $ | 0.30 | $ | (0.05) | ||||||||
Shares used in computing net income (loss) per share: | ||||||||||||||||
Basic | 187,682 | 178,676 | 187,433 | 175,373 | ||||||||||||
Diluted | 193,015 | 186,493 | 192,820 | 175,373 | ||||||||||||
INCYTE CORPORATION | ||||||
CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||
(unaudited, in thousands) | ||||||
June 30, | December 31, | |||||
2016 | 2015 | |||||
ASSETS | ||||||
Cash, cash equivalents and marketable securities | $ | 629,191 | $ | 707,783 | ||
Restricted cash and investments | 938 | 14,493 | ||||
Accounts receivable | 129,486 | 114,450 | ||||
Property and equipment, net | 138,513 | 86,006 | ||||
Inventory | 21,664 | 19,338 | ||||
Prepaid expenses and other assets | 29,809 | 30,122 | ||||
Long term investment | 31,444 | 35,248 | ||||
Other intangible assets, net | 269,205 | - | ||||
In-process research and development | 12,000 | - | ||||
Goodwill | 155,725 | - | ||||
Total assets | $ | 1,417,975 | $ | 1,007,440 | ||
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||
Accounts payable, accrued expenses and other liabilities | $ | 185,338 | $ | 203,880 | ||
Deferred revenue—collaborative agreements | 6,083 | 12,512 | ||||
Convertible senior notes | 635,491 | 619,893 | ||||
Acquisition-related contingent consideration | 294,000 | - | ||||
Stockholders’ equity | 297,063 | 171,155 | ||||
Total liabilities and stockholders’ equity | $ | 1,417,975 | $ | 1,007,440 | ||
View source version on businesswire.com: http://www.businesswire.com/news/home/20160809005281/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