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Incyte Reports 2019 Third Quarter Financial Results and Provides Updates on Key Clinical Programs - Total product and royalty revenues of $534 million (+24% vs. Q3 2018) and Jakafi (ruxolitinib) revenues of $433 million

Key Takeaway: Incyte Reports 2019 Third Quarter Financial and Provides Updates on Key Clinical Programs Conference Call and Webcast Scheduled Today WILMINGTON, Del. - October 29, 2019 - Incyte Corporation (Nasdaq:INCY) today reports 2019 third quarter financial results and provides a statu

Full Press Release Details

Incyte Reports 2019 Third Quarter Financial
and Provides Updates on Key Clinical Programs
Conference Call and Webcast Scheduled Today
WILMINGTON, Del. - October 29, 2019 - Incyte
Corporation (Nasdaq:INCY) today reports 2019 third quarter financial results and provides a status update on the Company's
development portfolio.
"Revenue growth continues to be very strong, driven by
robust demand for Jakafi (ruxolitinib) in all three approved indications and, as a result, we are raising guidance for full year
Jakafi net sales," stated Herv Hoppenot, Chief Executive Officer, Incyte. "At the beginning of 2019, we laid
out an ambitious set of development goals for our late-stage portfolio, and in the third quarter we have continued to execute against
them. The recent clinical success in the REACH2 trial of ruxolitinib in steroid-refractory acute GVHD; the updated data from pemigatinib
in cholangiocarcinoma and subsequent NDA submission; and the recently-presented 52-week data from the randomized Phase 2 trial
of ruxolitinib cream in vitiligo are all illustrative of the significant progress we have made this year."
Oncology - key highlights
The positive result of REACH2, the Phase 3 study evaluating
ruxolitinib in patients with steroid-refractory acute graft-versus-host disease (GVHD), was announced in October. The study met
its primary endpoint of superior overall response rate (ORR) at Day 28 with ruxolitinib treatment compared to best available therapy.
No new safety signals were observed, and the ruxolitinib safety profile in REACH2 was consistent with that seen in previously reported
studies in steroid-refractory acute GVHD.
A recent interim efficacy and safety analysis conducted by an
Independent Data Monitoring Committee (IDMC) recommended that the Phase 3 REACH3 trial of ruxolitinib in patients with steroid-refractory
chronic GVHD should continue without modification. The result of REACH3 is expected in 2020.
The top-line result from GRAVITAS-301, the Phase 3 trial
of itacitinib as a treatment for patients with newly diagnosed acute GVHD, is expected to be available at the end of
2019. GRAVITAS-309, a Phase 3 trial of itacitinib as a treatment for patients with newly diagnosed chronic GVHD, was
initiated in January of this year with results expected in 2021.
The NDA seeking approval for pemigatinib as a second-line treatment
for cholangiocarcinoma patients with FGFR2 fusions or rearrangements was submitted to the U.S. Food and Drug Administration
(FDA) under Breakthrough Therapy designation. Data from FIGHT-202, which supported the NDA, were presented at the recent European
Society for Medical Oncology (ESMO) Congress.
Enrollment in the continuous dosing cohort of FIGHT-201, the
Phase 2 trial of pemigatinib in patients with bladder cancer, is expected to complete by the end of 2019 and FIGHT-207, a Phase
2 solid tumor-agnostic trial evaluating pemigatinib in patients with driver-activations of FGF/FGFR, has been initiated.
Indication and status
Ruxolitinib (JAK1/JAK2) Steroid-refractory acute GVHD: Phase 3 (REACH2) met primary endpoint 1 Steroid-refractory chronic GVHD: Phase 3 (REACH3) 1 Essential thrombocythemia: Phase 2 (RESET) Refractory myelofibrosis: Phase 2 with PI3K , PIM or JAK1 inhibition
Itacitinib (JAK1) Treatment-na ve acute GVHD: Phase 3 (GRAVITAS-301) Treatment-na ve chronic GVHD: Phase 3 (GRAVITAS-309)
Pemigatinib (FGFR1/2/3) Cholangiocarcinoma: Phase 2 (FIGHT-202), Phase 3 (FIGHT-302) Bladder cancer: Phase 2 (FIGHT-201) 8p11 MPN: Phase 2 (FIGHT-203) Tumor agnostic: Phase 2 (FIGHT-207)
Parsaclisib (PI3K ) Follicular lymphoma: Phase 2 (CITADEL-203) Marginal zone lymphoma: Phase 2 (CITADEL-204) Mantle cell lymphoma: Phase 2 (CITADEL-205)
INCMGA0012 (PD-1) 1 MSI-high endometrial cancer: Phase 2 (POD1UM-101) Merkel cell carcinoma: Phase 2 (POD1UM-201) Anal cancer: Phase 2 (POD1UM-202)
Inflammation and autoimmunity (IAI) - key highlights
Evidence of continued improvement with longer-term treatment
was shown in the 52-week data from the randomized Phase 2 trial of ruxolitinib cream in patients with vitiligo, which were recently
presented at the European Academy of Dermatology and Venereology (EADV) Congress. The Phase 3 TRuE-V development program of ruxolitinib
cream in patients with vitiligo was initiated in September, with initial results expected in 2021.
The Phase 3 TRuE-AD development program of ruxolitinib cream
in patients with atopic dermatitis is ongoing, with initial results expected in the first half of 2020.
Indication and status
Ruxolitinib cream (JAK1/JAK2) Atopic dermatitis: Phase 3 (TRuE-AD) Vitiligo: Phase 3 (TRuE-V)
INCB54707 (JAK1) Hidradenitis suppurativa: Phase 2
Itacitinib (JAK1) Ulcerative colitis: Phase 2
Parsaclisib (PI3K ) Autoimmune hemolytic anemia: Phase 2 Sj gren's syndrome: Phase 2
Discovery and early development - key highlights
Incyte's portfolio of earlier-stage clinical candidates
Modality Candidates
Small molecules INCB01158 (ARG) 1 , INCB81776 (AXL/MER), INCB62079 (FGFR4), epacadostat (IDO1), INCB59872 (LSD1), INCB53914 (PIM), INCB86550 (PD-L1)
Monoclonal antibodies 2 INCAGN1876 (GITR), INCAGN2385 (LAG-3), INCAGN1949 (OX40), INCAGN2390 (TIM-3)
Bispecific antibodies MCLA-145 (PD-L1xCD137) 3
Partnered - key highlights
The status of Incyte's partnered compounds is detailed
Indication and status
Baricitinib (JAK1/JAK2) 1 Atopic dermatitis: Phase 3 (BREEZE-AD) Systemic lupus erythematosus: Phase 3 Severe alopecia areata: Phase 3
Capmatinib (MET) 2 NSCLC (with MET exon 14 skipping mutations): NDA expected in Q4 2019 (by Novartis)
2019 Third-Quarter and Year-to-Date Financial Results
The financial measures presented in this press release
for the three and nine months ended September 30, 2019 and 2018 have been prepared by the Company in accordance with U.S.
Generally Accepted Accounting Principles ("GAAP"), unless otherwise identified as a Non-GAAP financial measure.
Management believes that Non-GAAP information is useful for investors, when considered in conjunction with Incyte's
GAAP disclosures. Management uses such information internally and externally for establishing budgets, operating goals and
financial planning purposes. These metrics are also used to manage the Company's business and monitor performance. The
Company adjusts, where appropriate, for expenses in order to reflect the Company's core operations. The Company
believes these adjustments are useful to investors by providing an enhanced understanding of the financial performance of the
Company's core operations. The metrics have been adopted to align the Company with disclosures provided by industry
Beginning in the first quarter of 2019, after reviewing our
Reconciliation of GAAP Net Income to Selected Non-GAAP Adjusted Information with the U.S. Securities & Exchange Commission,
we no longer adjust for upfront consideration and milestones that are part of collaboration agreements with new or existing partners.
This revised methodology is reflected in this press release for the three and nine months ended September 30, 2019 and 2018.
Non-GAAP information is not prepared under a comprehensive set
of accounting rules and should only be used in conjunction with and to supplement Incyte's operating results as reported
under GAAP. Non-GAAP measures may be defined and calculated differently by other companies in our industry.
The Company's 2019 financial guidance related to research
and development and selling, general and administrative expenses does not include estimates associated with any potential future
strategic transactions.
Revenues For the quarter ended September 30, 2019,
net product revenues of Jakafi were $433 million as compared to $348 million for the same period in 2018, representing 25 percent
growth. For the nine months ended September 30, 2019, net product revenues of Jakafi were $1.2 billion as compared to $1.0 billion
for the same period in 2018, representing 21 percent growth. For the quarter ended September 30, 2019, net product revenues of
Iclusig (ponatinib) were $21 million as compared to $20 million for the same period in 2018. For the nine months
ended September 30, 2019, net product revenues of Iclusig were $66 million as compared to $61 million for the same period in 2018.
For the quarter and nine months ended September 30, 2019, product
royalties from sales of Jakavi (ruxolitinib), which has been out-licensed to Novartis outside of the United
States, were $58 million and $161 million, respectively, as compared to $51 million and $139 million, respectively, for the same
periods in 2018. For the quarter and nine months ended September 30, 2019, product royalties from sales of Olumiant
(baricitinib), which has been out-licensed to Lilly globally, were $22 million and $57 million, respectively, as compared to $11
million and $26 million, respectively, for the same periods in 2018.
For the quarter and nine months ended September 30, 2019, milestone
and contract revenues earned from our collaborative partners were $18 million and $78 million, respectively, as compared to $20
million and $120 million, respectively, for the same periods in 2018.
For the quarter and nine months ended September 30, 2019,
total revenues were $552 million and $1.6 billion, respectively, as compared to $450 million and $1.4 billion, respectively, for
the same periods in 2018.
Year Over Year Revenue Growth
(in thousands, unaudited)
Three Months Ended Nine Months Ended
September 30, % September 30, %
2019 2018 Change 2019 2018 Change
Revenues:
Jakafi net product revenue $ 433,387 $ 347,567 25 % $ 1,218,504 $ 1,006,911 21 %
Iclusig net product revenue 20,611 20,148 2 % 65,640 60,833 8 %
Jakavi product royalty revenues 58,440 50,923 15 % 160,906 139,361 15 %
Olumiant product royalty revenues 21,643 11,000 97 % 56,820 26,231 117 %
Product and royalty revenues 534,081 429,638 24 % 1,501,870 1,233,336 22 %
Milestone and contract revenues 17,500 20,000 77,500 120,000
Other revenues - 45 - 145
Total GAAP revenues $ 551,581 $ 449,683 23 % $ 1,579,370 $ 1,353,481 17 %
Cost of product revenues GAAP cost of product revenues
for the quarter and nine months ended September 30, 2019 was $30 million and $82 million, respectively, as compared to $25 million
and $68 million, respectively, for the same periods in 2018. Non-GAAP cost of product revenues for the quarter and nine months
ended September 30, 2019 was $24 million and $65 million, respectively, as compared to $19 million and $52 million, respectively,
for the same periods in 2018. Non-GAAP cost of product revenues excludes the amortization of licensed intellectual property for
Iclusig relating to the acquisition of the European business of ARIAD Pharmaceuticals, Inc. and the cost of stock-based compensation.
Research and development expenses GAAP research
and development expenses for the quarter and nine months ended September 30, 2019 were $281 million and $841 million, respectively,
as compared to $293 million and $894 million, respectively, for the same periods in 2018. The decrease in GAAP research and development
expenses over the prior year quarter and prior year nine month period was driven primarily by our decision to no longer co-fund
the development of baricitinib with Lilly and lower costs related to the epacadostat program, partially offset by costs to advance
Last updated: Oct 29, 2019