Incyte Reports 2016 Third-Quarter Financial Results and Updates Key Clinical Programs
$224 million of 2016 third-quarter net product revenues from Jakafi® (ruxolitinib), representing 39 percent growth over the same period last year- Jakafi included as a recommended treatment for patients with myelofibrosis in the NCCN® Guidelines for myeloproliferative neoplasms (MPNs)
- Updated Phase 1 data from ECHO-202 reinforced durability of anti-tumor response in patients with advanced or metastatic melanoma treated with epacadostat plus Keytruda® (pembrolizumab)
Conference Call and Webcast Scheduled Today at
The Company also highlighted progress being made across its clinical portfolio. Within the targeted therapies segment, two Phase 2 trials of INCB54828, a selective FGFR inhibitor, are now open for recruitment in bladder cancer and cholangiocarcinoma, respectively. In immuno-oncology, updated Phase 1 data from ECHO-202 were recently presented at the
“Incyte continues to deliver dynamic sales growth from Jakafi in the U.S. and now from Iclusig in
2016 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, | % | ||||||||||||||||
2016 | 2015 | Change | 2016 | 2015 | Change | ||||||||||||||
Revenues: | |||||||||||||||||||
Jakafi net product revenue | $ | 223,892 | $ | 161,259 | 39% | $ | 615,285 | $ | 418,994 | 47% | |||||||||
Iclusig net product revenue | 12,731 | - | - | 16,721 | - | - | |||||||||||||
Product royalty revenues | 29,626 | 18,138 | 63% | 77,486 | 51,175 | 51% | |||||||||||||
Contract revenues | 3,214 | 8,214 | - | 69,643 | 39,643 | - | |||||||||||||
Other revenues | 6 | - | - | 86 | 58 | - | |||||||||||||
Total revenues | $ | 269,469 | $ | 187,611 | 44% | $ | 779,221 | $ | 509,870 | 53% | |||||||||
In
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
Change in fair value of acquisition-related contingent consideration The change in fair value of acquisition-related contingent consideration of
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
2016 Financial Guidance
The Company has updated its full year 2016 financial guidance, as detailed below.
Current |
Previous |
||||
Jakafi net product revenues |
$850-$855 million | $825-$835 million | |||
Iclusig net product revenues |
$25-$30 million | Unchanged | |||
Research and development expenses |
$570-$580 million | $620-$630 million | |||
Selling, general and administrative expenses |
$285-$310 million | Unchanged | |||
Change in fair value of acquisition-related contingent consideration |
$17 million | Unchanged | |||
Portfolio Update
Cancer – Targeted Therapies
Two trials of INCB54828, a selective FGFR inhibitor, in patients with bladder cancer and cholangiocarcinoma, respectively, harboring FGFR alterations are now open for recruitment.
Indication |
Status Update |
|||||
Ruxolitinib (JAK1/JAK2) |
Graft versus host disease | Pivotal program expected to begin in the fourth quarter 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 begin in the fourth quarter 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, cholangiocarcinoma | Phase 2 open for recruitment | ||||
INCB54329 (BRD) |
Advanced malignancies | Phase 1/2 dose-escalation | ||||
INCB57643 (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
Updated Phase 1 data from the ECHO-202 trial of epacadostat plus pembrolizumab was recently presented at ESMO, showing durable responses in patients with advanced or metastatic melanoma, and a well-tolerated safety profile. These data reinforce Incyte’s confidence in the decision to move this immunotherapy combination into the ongoing ECHO-301 Phase 3 trial for the first-line treatment of patients with advanced or metastatic melanoma.
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, bladder 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 completed; enrollment suspended | ||||
INCAGN1876 (GITR, co-developed with Agenus) |
Solid tumors | Phase 1/2 dose-escalation | ||||
INCAGN1949 (OX40, co-developed with Agenus) |
Solid tumors | Phase 1/2 dose-escalation expected to begin in the fourth quarter 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
Data from Incyte’s Phase 2 trial of topical ruxolitinib for the treatment of patients with alopecia areata have been accepted for presentation at the National Alopecia Areata Foundation’s Alopecia Areata Research Summit on
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,
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
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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
1 In
INCYTE CORPORATION | |||||||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||||
(unaudited, in thousands, except per share amounts) | |||||||||||||||||
Three Months Ended | Nine Months Ended | ||||||||||||||||
September 30, | September 30, | ||||||||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||||||||
Revenues: | |||||||||||||||||
Product revenues, net | $ | 236,623 | $ | 161,259 | $ | 632,006 | $ | 418,994 | |||||||||
Product royalty revenues | 29,626 | 18,138 | 77,486 | 51,175 | |||||||||||||
Contract revenues | 3,214 | 8,214 | 69,643 | 39,643 | |||||||||||||
Other revenues | 6 | - | 86 | 58 | |||||||||||||
Total revenues | 269,469 | 187,611 | 779,221 | 509,870 | |||||||||||||
Costs and expenses: | |||||||||||||||||
Cost of product revenues (including definite-lived intangible amortization) | 20,205 | 8,040 | 38,577 | 17,268 | |||||||||||||
Research and development | 143,184 | 132,073 | 420,276 | 362,882 | |||||||||||||
Selling, general and administrative | 75,776 | 47,599 | 207,166 | 144,147 | |||||||||||||
Change in fair value of acquisition-related contingent consideration | 8,012 | - | 10,283 | - | |||||||||||||
Total costs and expenses | 247,177 | 187,712 | 676,302 | 524,297 | |||||||||||||
Income (loss) from operations | 22,292 | (101) | 102,919 | (14,427) | |||||||||||||
Interest and other income, net | 1,188 | 3,026 | 3,818 | 5,800 | |||||||||||||
Interest expense | (9,479) | (11,209) | (29,275 | (35,390) | |||||||||||||
Unrealized gain (loss) on long term investment | 24,301 | (31,289) | 20,497 | (4,115) | |||||||||||||
Income (loss) before provision for income taxes | 38,302 | (39,573) | 97,959 | (48,132) | |||||||||||||
Provision for income taxes | 1,425 | 9 | 2,610 | 513 | |||||||||||||
Net income (loss) | $ | 36,877 | $ | (39,582 | $ | 95,349 | $ | (48,645) | ) | ||||||||
Net income (loss) per share: | |||||||||||||||||
Basic | $ | 0.20 | $ | (0.22) | $ | 0.51 | $ | (0.27) | |||||||||
Diluted | $ | 0.19 | $ | (0.22) | $ | 0.49 | $ | (0.27) | |||||||||
Shares used in computing net income (loss) per share: | |||||||||||||||||
Basic | 188,029 | 181,387 | 187,632 | 177,378 | |||||||||||||
Diluted | 194,265 | 181,387 | 193,754 | 177,378 | |||||||||||||
INCYTE CORPORATION | |||||||
CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||
(unaudited, in thousands) | |||||||
September 30, | December 31, | ||||||
2016 | 2015 | ||||||
ASSETS | |||||||
Cash, cash equivalents and marketable securities | $ | 716,585 | $ | 707,783 | |||
Restricted cash and investments | 949 | 14,493 | |||||
Accounts receivable | 131,523 | 114,450 | |||||
Property and equipment, net | 151,942 | 86,006 | |||||
Inventory | 18,907 | 19,338 | |||||
Prepaid expenses and other assets | 37,021 | 30,122 | |||||
Long term investment | 55,745 | 35,248 | |||||
Other intangible assets, net | 263,821 | - | |||||
In-process research and development | 12,000 | - | |||||
Goodwill | 155,702 | - | |||||
Total assets | $ | 1,544,195 | $ | 1,007,440 | |||
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||
Accounts payable, accrued expenses and other liabilities | $ | 229,907 | $ | 203,880 | |||
Deferred revenue—collaborative agreements | 2,868 | 12,512 | |||||
Convertible senior notes | 643,434 | 619,893 | |||||
Acquisition-related contingent consideration | 298,000 | - | |||||
Stockholders’ equity | 369,986 | 171,155 | |||||
Total liabilities and stockholders’ equity | $ | 1,544,195 | $ | 1,007,440 | |||
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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