Incyte Reports 2016 Fourth-Quarter and Year-End Financial Results, Provides 2017 Financial Guidance and Updates on Key Clinical Programs
$238 million of 2016 fourth-quarter net product revenues from Jakafi® (ruxolitinib), representing 30 percent growth over the same period last year and$853 million of 2016 full-year net product revenues from Jakafi, representing 42 percent growth over last year- Multiple pivotal programs expected to commence this year, including the combination of epacadostat and pembrolizumab in four additional solid tumor indications
- Expanding early-stage R&D portfolio, including the FGFR4 inhibitor program as well as recent collaborations in the fields of bispecific antibodies and arginase inhibition
Conference Call and Webcast Scheduled Today at
“We have had a very productive year at
Baricitinib, a potential new oral treatment for patients with rheumatoid arthritis (RA) licensed to
Portfolio Update
Cancer – Targeted Therapies
The pivotal program investigating ruxolitinib as a treatment for patients with graft-versus-host disease (GVHD) has begun. REACH1, the pivotal Phase 2 trial in patients with steroid-refractory acute GVHD, enrolled its first patient in
A pivotal program of ruxolitinib as a treatment for patients with essential thrombocythemia is also expected to begin in 2017.
Itacitinib (formerly INCB39110), Incyte’s selective JAK1 inhibitor, is anticipated to enter a global pivotal development program for the treatment of patients with treatment-naïve acute GVHD during 2017.
In
Indication | Status Update | |||||
Ruxolitinib (JAK1/JAK2) | Steroid-refractory acute GVHD | Pivotal (REACH1) trial underway; Phase 3 (REACH2) trial expected to begin in 2017 | ||||
Ruxolitinib (JAK1/JAK2) | Steroid-refractory chronic GVHD | Phase 3 (REACH3) trial expected to begin in 2017 | ||||
Ruxolitinib (JAK1/JAK2) | Essential thrombocythemia | Pivotal program expected to begin in 2017 | ||||
Itacitinib (JAK1) | Treatment-naïve acute GVHD | Pivotal program expected to begin in 2017 | ||||
Itacitinib (JAK1) | Non-small cell lung cancer | Phase 1/2 in combination with osimertinib (EGFR) | ||||
INCB52793 (JAK1) | Advanced malignancies | Phase 1/2 dose-escalation | ||||
INCB50465 (PI3Kδ) | Diffuse large B cell lymphoma | Phase 2 (CITADEL-202) expected to begin in first half of 2017 | ||||
INCB54828 (FGFR1/2/3) | Bladder cancer, cholangiocarcinoma; 8p11 MPNs | Phase 2 | ||||
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 | ||||
INCB62079 (FGFR4) | Hepatocellular carcinoma | Phase 1/2 dose-escalation expected to begin in 2017 | ||||
Cancer – Immune Therapies
In
In
In
Indication | Status Update | |||||
Epacadostat (IDO1) | Unresectable or metastatic melanoma | Phase 3 (ECHO-301) in combination with pembrolizumab (PD-1) | ||||
NSCLC, renal, bladder and head & neck cancer | Phase 3 in combination with pembrolizumab (PD-1) expected to begin in 2017 | |||||
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) | |||||
NSCLC, bladder cancer | Phase 1/2 (ECHO-110) dose-escalation in combination with atezolizumab (PD-L1) | |||||
INCB01158 (ARG, co-developed with Calithera) |
Solid tumors | Phase 1/2 dose-escalation | ||||
INCSHR1210 (PD-1, licensed from Hengrui) |
Solid tumors | Phase 1/2 dose-escalation completed; enrollment suspended | ||||
INCAGN1876 (GITR) | Solid tumors | Phase 1/2 dose-escalation | ||||
INCAGN1949 (OX40) | Solid tumors | Phase 1/2 dose-escalation | ||||
PD-1 platform study | Solid tumors | Phase 1/2, pembrolizumab (PD-1) in combination with itacitinib (JAK1) or INCB50465 (PI3Kδ) | ||||
JAK1 platform study | Solid tumors | Phase 1/2, itacitinib (JAK1) in combination with epacadostat (IDO1) or INCB50465 (PI3Kδ) | ||||
Non-oncology
A Phase 2 trial of topical ruxolitinib for the treatment of patients with atopic dermatitis has recently been initiated, and a Phase 2 trial in patients with vitiligo is expected to begin during 2017.
Indication | Status Update | |||||
Topical ruxolitinib (JAK1/JAK2) | Alopecia areata, atopic dermatitis | Phase 2 | ||||
Vitiligo | Phase 2 expected to begin in 2017 | |||||
Partnered
In
Lilly has announced its intention to initiate a Phase 3 program investigating baricitinib as a treatment for patients with psoriatic arthritis during 2017, and
Indication | Status Update | |||||
Baricitinib (JAK1/JAK2, licensed to Lilly) | Rheumatoid arthritis | Approved in Europe; FDA review extended by three months | ||||
Psoriatic arthritis | Phase 3 expected to begin in 2017 | |||||
Atopic dermatitis, systemic lupus erythematosus | Phase 2 | |||||
Capmatinib (c-MET, licensed to Novartis) | Non-small cell lung cancer, liver cancer | Phase 2 in EGFR wild-type ALK negative NSCLC patients with c-MET amplification and mutation | ||||
2016 Fourth-Quarter and Full-Year Financial Results
Revenues For the quarter ended
For the quarter and seven month period ended
For the quarter and full year ended
For the quarter and full year ended
For the quarter ended
Year Over Year Revenue Growth | ||||||||||||||||||||||
(in thousands, unaudited) | ||||||||||||||||||||||
Three Months Ended | Twelve Months Ended | |||||||||||||||||||||
December 31, | % | December 31, | % | |||||||||||||||||||
2016 | 2015 | Change | 2016 | 2015 | Change | |||||||||||||||||
Revenues: | ||||||||||||||||||||||
Jakafi net product revenue | $ | 237,531 | $ | 182,021 | 30% | $ | 852,816 | $ | 601,015 | 42% | ||||||||||||
Iclusig net product revenue | 12,867 | - | - | 29,588 | - | - | ||||||||||||||||
Product royalty revenues | 33,225 | 23,646 | 41% | 110,711 | 74,821 | 48% | ||||||||||||||||
Contract revenues | 42,869 | 38,214 | - | 112,512 | 77,857 | - | ||||||||||||||||
Other revenues | 6 | - | - | 92 | 58 | - | ||||||||||||||||
Total revenues | $ | 326,498 | $ | 243,881 | 34% | $ | 1,105,719 | $ | 753,751 | 47% | ||||||||||||
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
Change in fair value of acquisition-related contingent consideration The change in fair value of acquisition-related contingent consideration of
Unrealized loss on long term investment Unrealized loss on long term investment for the quarter and full year ended
Net income Net income for the quarter ended
Cash, cash equivalents and marketable securities position As of
2017 Financial Guidance
The Company has provided full year 2017 financial guidance, as detailed below.
Guidance | |||
Jakafi net product revenues | $1,020-$1,070 million | ||
Iclusig net product revenues | $60-$65 million | ||
Research and development expenses: ongoing | $785-$835 million | ||
Research and development expenses: anticipated one-time items* | $205 million | ||
Selling, general and administrative expenses | $340-$360 million | ||
Change in fair value of acquisition-related contingent consideration | $30-$35 million |
* One-time items related to the amended Agenus collaboration, and the Merus and Calithera collaborations |
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 release contain predictions, estimates and other forward-looking statements, including without limitation statements regarding: the Company’s financial guidance for 2017 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 and whether baricitinib will be approved in the U.S.; and plans and expectations regarding the Company’s product pipeline and strategy - including timelines for advancing its drug candidates through clinical trials (including enrollment and commencement), whether certain trials will serve as the basis for registration, timelines for regulatory submissions and timelines for releasing trial data, and whether any specific program will be successful - and plans and expectations regarding development activities of the Company’s collaboration partners.
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, including pivotal 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
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INCYTE CORPORATION | |||||||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||||
(unaudited, in thousands, except per share amounts) | |||||||||||||||||
Three Months Ended | Twelve Months Ended | ||||||||||||||||
December 31, | December 31, | ||||||||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||||||||
Revenues: | |||||||||||||||||
Product revenues, net | $ | 250,398 | $ | 182,021 | $ | 882,404 | $ | 601,015 | |||||||||
Product royalty revenues | 33,225 | 23,646 | 110,711 | 74,821 | |||||||||||||
Contract revenues | 42,869 | 38,214 | 112,512 | 77,857 | |||||||||||||
Other revenues | 6 | - | 92 | 58 | |||||||||||||
Total revenues | 326,498 | 243,881 | 1,105,719 | 753,751 | |||||||||||||
Costs and expenses: | |||||||||||||||||
Cost of product revenues (including | |||||||||||||||||
definite-lived intangible amortization) | 19,610 | 9,704 | 58,187 | 26,972 | |||||||||||||
Research and development | 161,585 | 116,630 | 581,861 | 479,514 | |||||||||||||
Selling, general and administrative | 96,085 | 52,467 | 303,251 | 196,614 | |||||||||||||
Change in fair value of acquisition-related | |||||||||||||||||
contingent consideration | 7,139 | - | 17,422 | - | |||||||||||||
Total costs and expenses | 284,419 | 178,801 | 960,721 | 703,100 | |||||||||||||
Income from operations | 42,079 | 65,080 | 144,998 | 50,651 | |||||||||||||
Interest and other income, net | 594 | 1,289 | 4,412 | 7,089 | |||||||||||||
Interest expense | (9,470) | (10,213) | (38,745) | (45,603) | |||||||||||||
Unrealized loss on long term investment | (23,758) | (466) | (3,261) | (4,581) | |||||||||||||
Income before provision for income taxes | 9,445 | 55,690 | 107,404 | 7,556 | |||||||||||||
Provision for income taxes | 572 | 512 | 3,182 | 1,025 | |||||||||||||
Net income | $ | 8,873 | $ | 55,178 | $ | 104,222 | $ | 6,531 | |||||||||
Net income per share: | |||||||||||||||||
Basic | $ | 0.05 | $ | 0.30 | $ | 0.55 | $ | 0.04 | |||||||||
Diluted | $ | 0.05 | $ | 0.29 | $ | 0.54 | $ | 0.03 | |||||||||
Shares used in computing net income per share: | |||||||||||||||||
Basic | 188,598 | 186,269 | 187,873 | 179,601 | |||||||||||||
Diluted | 195,187 | 193,367 | 194,125 | 187,302 | |||||||||||||
INCYTE CORPORATION | ||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
(unaudited, in thousands) | ||||||||
December 31, | December 31, | |||||||
2016 | 2015 | |||||||
ASSETS | ||||||||
Cash, cash equivalents and marketable securities | $ | 808,546 | $ | 707,783 | ||||
Restricted cash and investments | 902 | 14,493 | ||||||
Accounts receivable | 148,758 | 114,450 | ||||||
Property and equipment, net | 167,679 | 86,006 | ||||||
Inventory | 19,299 | 19,338 | ||||||
Prepaid expenses and other assets | 35,396 | 30,122 | ||||||
Long term investment | 31,987 | 35,248 | ||||||
Other intangible assets, net | 258,437 | - | ||||||
In-process research and development | 12,000 | - | ||||||
Goodwill | 155,593 | - | ||||||
Total assets | $ | 1,638,597 | $ | 1,007,440 | ||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
Accounts payable, accrued expenses and other liabilities | $ | 266,649 | $ | 203,880 | ||||
Deferred revenue—collaborative agreements | - | 12,512 | ||||||
Convertible senior notes | 651,481 | 619,893 | ||||||
Acquisition-related contingent consideration | 301,000 | - | ||||||
Stockholders’ equity | 419,467 | 171,155 | ||||||
Total liabilities and stockholders’ equity | $ | 1,638,597 | $ | 1,007,440 | ||||
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Source:
Incyte Corporation
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Catalina Loveman, +1 302-498-6171
cloveman@incyte.com
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Investors
Michael Booth, DPhil, +1 302-498-5914
mbooth@incyte.com