WILMINGTON, Del.--(BUSINESS WIRE)--Incyte Corporation (Nasdaq:INCY) today reports 2019 first quarter financial results and provides a status update on the Company’s development portfolio.
“Underlying demand for Jakafi is strong, and we look forward to the U.S. Food and Drug Administration’s (FDA) decision on ruxolitinib’s approval in steroid-refractory acute graft-versus-host disease (GVHD),” stated Hervé Hoppenot, Chief Executive Officer, Incyte. “We continue to make progress across multiple programs and towards our key strategic goals of further diversifying our revenue base and accelerating near-term growth. We expect to present data from ruxolitinib cream in patients with vitiligo later in the second quarter and to progress the program into Phase 3 development. In addition, we expect to file a New Drug Application (NDA) with the FDA for pemigatinib and to receive the results from three Phase 3 trials of JAK inhibition in GVHD by the end of this year.”
Portfolio Update
Oncology – key highlights
The FDA review of the sNDA seeking approval of ruxolitinib for the treatment of steroid-refractory acute GVHD is ongoing; the Prescription Drug User Fee Act (PDUFA) date is May 24, 2019. Data from the successful REACH1 trial provided the basis for the application, and Incyte is ready for the U.S. launch should ruxolitinib be approved in this new indication.
The Phase 3 GRAVITAS-301 trial of itacitinib as a treatment for patients with newly-diagnosed acute GVHD has now completed enrollment, and results are expected before the end of 2019. If successful, Incyte expects to submit applications seeking marketing approval for itacitinib in major markets globally. GRAVITAS-309, a Phase 3 trial of itacitinib as a treatment for patients with newly-diagnosed chronic GVHD, was launched in January of this year.
Incyte expects to submit the NDA for pemigatinib as a second-line treatment for patients with FGFR2 translocated cholangiocarcinoma in the second half of 2019, and to initiate the Phase 3 trial for the first-line treatment of patients with cholangiocarcinoma in the coming months. The presentation of additional data from FIGHT-202, the Phase 2 trial evaluating pemigatinib as a second-line therapy in patients with cholangiocarcinoma, is planned in the second half of the year. Enrollment in the continuous dosing cohort of the Phase 2 trial of pemigatinib in patients with bladder cancer is expected to complete by the end of 2019, and a Phase 2 tumor agnostic study of pemigatinib is expected to open before the end of 2019.
| Year Over Year Revenue Growth | ||||||||||||
| (in thousands, unaudited) | ||||||||||||
| Three Months Ended | March 31, | % | ||||||||||
| 2019 | 2018 | Change | ||||||||||
| Revenues: | ||||||||||||
| Jakafi net product revenue | $ 375,611 | $ 313,720 | 20% | |||||||||
| Iclusig net product revenue | 20,638 | 20,785 | -1% | |||||||||
| Jakavi product royalty revenues | 45,571 | 41,337 | 10% | |||||||||
| Olumiant product royalty revenues | 16,037 | 6,379 | 151% | |||||||||
| Product-related revenues | 457,857 | 382,221 | 20% | |||||||||
| Milestone and contract revenues | 40,000 | - | ||||||||||
| Other revenues | - | 61 | ||||||||||
| Total GAAP revenues | $ 497,857 | $ 382,282 | 30% | |||||||||
Non-GAAP research and development expenses for the quarter ended March 31, 2019 and 2018 were $243 million and $279 million, respectively, including upfront and milestone expenses related to collaborative agreements of $0 million and $12 million, respectively. Non-GAAP research and development expenses for the quarter ended March 31, 2019 and 2018 exclude the cost of stock-based compensation.
Selling, general and administrative expenses GAAP selling, general and administrative expenses for the quarter ended March 31, 2019 and 2018 were $124 million and $121 million, respectively.
Non-GAAP selling, general and administrative expenses for the quarter ended March 31, 2019 and 2018 were $111 million and $109 million, respectively. Non-GAAP selling, general and administrative expenses exclude the cost of stock-based compensation.
Change in fair value of acquisition-related contingent consideration GAAP change in fair value of acquisition-related contingent consideration for the quarter ended March 31, 2019 and 2018 was $7 million.
Unrealized gain on long term investments GAAP unrealized gain on long-term investments for the quarter ended March 31, 2019 and 2018 was $21 million and $23 million, respectively. The unrealized gain on long-term investments represents the fair market value adjustments of the Company’s investments in Agenus, Calithera, Merus and Syros.
Net income (loss) GAAP net income for the quarter ended March 31, 2019 was $102 million, or $0.48 per basic and $0.47 per diluted share, as compared to net loss of $41 million, or $0.19 per basic and diluted share for the same period in 2018.
Non-GAAP net income for the quarter ended March 31, 2019 was $135 million, or $0.63 per basic and $0.62 per diluted share, as compared to Non-GAAP net loss of $15 million, or $0.07 per basic and diluted share for the same period in 2018.
Cash, cash equivalents and marketable securities position As of March 31, 2019 and December 31, 2018, cash, cash equivalents and marketable securities totaled $1.6 billion and $1.4 billion, respectively.
2019 Financial Guidance
The Company has updated its full year 2019 financial guidance, as detailed below.
| Current | Previous | |
| GAAP and Non-GAAP Jakafi net product revenues | $1,580 - $1,650 million | Unchanged |
| GAAP and Non-GAAP Iclusig net product revenues | $90 - $100 million | Unchanged |
| GAAP Cost of product revenues | $112 - $117 million | Unchanged |
| Non-GAAP Cost of product revenues(1) | $90 - $95 million | Unchanged |
| GAAP Research and development expenses | $1,145 - $1,195 million | $1,185 - $1,255 million |
| Non-GAAP Research and development expenses(2) | $1,020 - $1,070 million | $1,060 - $1,130 million(3) |
| GAAP Selling, general and administrative expenses | $471 - $521 million | Unchanged |
| Non-GAAP Selling, general and administrative expenses(2) | $420 - $470 million | Unchanged |
| GAAP Change in fair value of acquisition-related contingent consideration | $30 million | Unchanged |
| Non-GAAP Change in fair value of acquisition-related contingent consideration(4) | $0 million | Unchanged |
(1) Adjusted to exclude the amortization of licensed intellectual property for Iclusig relating to the acquisition of the European business of ARIAD Pharmaceuticals, Inc. and the estimated cost of stock-based compensation.
(2) Adjusted to exclude the estimated cost of stock-based compensation.
(3) Previously, Non-GAAP R&D guidance excluded $30 million upfront consideration and milestones under certain collaboration agreements.
(4) Adjusted to exclude the change in fair value of estimated future royalties relating to sales of Iclusig in the licensed territory relating to the acquisition of the European business of ARIAD Pharmaceuticals, Inc.
Future Non-GAAP financial measures may also exclude impairment of goodwill or other assets, changes in the fair value of equity investments in our collaboration partners, non-cash interest expense related to the amortization of the initial discount on our 2020 Senior Notes and the impact on our tax provision of discrete changes in our valuation allowance position on deferred tax assets.
Conference Call and Webcast Information
Incyte will hold a conference call and webcast this morning at 8:00 a.m. EDT. To access the conference call, please dial 877-407-3042 for domestic callers or 201-389-0864 for international callers. When prompted, provide the conference identification number, 13689554.
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 United States is 877-660-6853 and the dial-in number for international callers is 201-612-7415. To access the replay you will need the conference identification number, 13689554.
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 Incyte
Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical company focused on the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit the Company’s website at www.incyte.com.
Follow @Incyte on Twitter at https://twitter.com/Incyte.
About Jakafi® (ruxolitinib)
Jakafi is a first-in-class JAK1/JAK2 inhibitor approved by the U.S. Food and Drug Administration for treatment of people with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea. Jakafi is also indicated for treatment of people with intermediate or high-risk myelofibrosis (MF), including primary MF, post–polycythemia vera MF, and post–essential thrombocythemia MF.
Jakafi is marketed by Incyte in the United States and by Novartis as Jakavi® (ruxolitinib) outside the United States.
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 Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.
Incyte has an exclusive license from ARIAD Pharmaceuticals, Inc., since acquired by Takeda Pharmaceutical Company Limited, to develop and commercialize Iclusig in the European Union and 22 other countries, including Switzerland, Norway, Turkey, Israel and Russia.
