Full Press Release Details
Incyte Reports 2020 Second Quarter Financial
and Provides Updates on Key Clinical Programs
Conference Call and Webcast Scheduled Today
WILMINGTON, Del. - August
4, 2020 - Incyte (Nasdaq: INCY) today reports 2020 second quarter financial results, and provides a status update
on the Company's development portfolio.
"We continue to execute
successfully across all aspects of our business," stated Herv Hoppenot, Chief Executive Officer, Incyte. "Demand
for Jakafi (ruxolitinib) is robust and the recent approval of Pemazyre (pemigatinib), as well as
those of Monjuvi (tafasitamab-cxix) with MorphoSys and TabrectaTM (capmatinib) with Novartis, add to
our momentum. In addition, clinical updates from the tafasitamab and LIMBER programs at the recent EHA congress, the successful
outcome of REACH3, and our plan to submit an NDA seeking approval for ruxolitinib cream at the end of this year, further illustrate
the opportunities within our portfolio to drive additional diversification and growth."
LIMBER - key highlights
Positive proof-of-concept data for parsaclisib in combination
with ruxolitinib in myelofibrosis (MF) patients with an inadequate response to ruxolitinib monotherapy were presented at the virtual
25th Congress of the European Hematology Association (EHA). Incyte plans to initiate pivotal trials of the combination
of ruxolitinib and parsaclisib as both first-line therapy for MF patients and in MF patients with an inadequate response to ruxolitinib
Monotherapy treatment cohorts in the trials of INCB57643 (BET)
and INCB00928 (ALK2) in patients with myelofibrosis are being opened for recruitment, and these are expected to be followed by
the initiation of ruxolitinib combination trials with both agents. Further development of the combination of INCB53914 (PIM) plus
ruxolitinib has been discontinued.
| Indication and status | ||
| Once-a-day ruxolitinib (JAK1/JAK2) | Myelofibrosis and polycythemia vera: clinical pharmacology studies | |
| ruxolitinib + parsaclisib (JAK1/JAK2 + PI3K ) | Refractory myelofibrosis: Phase 3 in preparation First-line myelofibrosis: Phase 3 in preparation | |
| ruxolitinib + INCB57643 (JAK1/JAK2 + BET) | Refractory myelofibrosis: Phase 2 in preparation | |
| ruxolitinib + INCB00928 (JAK1/JAK2 + ALK2) | Myelofibrosis: Phase 2 in preparation |
Oncology beyond MPNs - key highlights
In July, the FDA granted approval for Monjuvi
(tafasitamab-cxix), an Fc-engineered anti-CD19 antibody, in combination with lenalidomide for the treatment of adult patients with
relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and who are not eligible for autologous stem cell transplant (ASCT).
Monjuvi was reviewed under Priority Review and granted accelerated approval based on overall response rate data from the L-MIND
trial of tafasitamab in combination with lenalidomide.
Incyte and MorphoSys will co-commercialize Monjuvi in the U.S.
Medical and commercial teams from both companies were ready for the early approval and launch activities are already underway,
including engagements with prescribing physicians and payors.
In May, Incyte and MorphoSys announced the validation of the
European Marketing Authorization Application (MAA) for tafasitamab. Incyte has exclusive development and commercialization rights
to tafasitamab outside of the U.S.
Updated results from the ongoing Phase 2 L-MIND study investigating
the combination of tafasitamab and lenalidomide in patients with relapsed or refractory DLBCL (r/r DLBCL) were reported at EHA.
The results were consistent with the primary analysis and those included in the U.S. prescribing information, and confirmed the
durability of the response and measurements of overall survival of tafasitamab in combination with lenalidomide followed by tafasitamab
monotherapy in ASCT-ineligible patients with r/r DLBCL.
In July, Incyte and Novartis
announced that the REACH3 study, evaluating ruxolitinib in patients with steroid-refractory chronic graft-versus-host disease (GVHD),
met its primary endpoint of overall response rate (ORR) at Month 6 and both key secondary endpoints (modified Lee symptom scale
and failure-free survival). No new safety signals were observed, and the ruxolitinib safety profile in REACH3 was consistent with
that seen in previously reported studies. REACH3 is the largest randomized trial ever conducted in the steroid-refractory chronic
GVHD setting. Data are being prepared for presentation at an upcoming medical meeting and for regulatory submission.
| Indication and status | ||
| ruxolitinib (JAK1/JAK2) | Steroid-refractory chronic GVHD: Phase 3 (REACH3) 1 Primary endpoint met | |
| itacitinib (JAK1) | Treatment-na ve chronic GVHD: Phase 3 (GRAVITAS-309) | |
| pemigatinib (FGFR1/2/3) | Cholangiocarcinoma: Phase 2 (FIGHT-202), Phase 3 (FIGHT-302); MAA under review Bladder cancer: Phase 2 (FIGHT-201, FIGHT-205) 8p11 MPN: Phase 2 (FIGHT-203) Tumor agnostic: Phase 2 (FIGHT-207) | |
| tafasitamab (CD19) 2 | r/r DLBCL: Phase 2 (L-MIND); Phase 3 (B-MIND); MAA under review First-line DLBCL: Phase 1b (First-MIND) | |
| parsaclisib (PI3K ) | Follicular lymphoma: Phase 2 (CITADEL-203) Marginal zone lymphoma: Phase 2 (CITADEL-204) Mantle cell lymphoma: Phase 2 (CITADEL-205) | |
| retifanlimab (PD-1) 3 | MSI-high endometrial cancer: Phase 2 (POD1UM-101) Merkel cell carcinoma: Phase 2 (POD1UM-201) SCAC: Phase 2 (POD1UM-202); Phase 3 (POD1UM-303) in preparation NSCLC: Phase 3 (POD1UM-304) in preparation |
Inflammation and Autoimmunity (IAI) - key highlights
The 44-week long-term safety and efficacy portions of both the
TRuE-AD1 and TRuE-AD2 Phase 3 trials of ruxolitinib cream in patients with mild-to-moderate atopic dermatitis are proceeding as
planned, and the NDA submission is expected at the end of 2020.
Data from the randomized Phase 2 trial of ruxolitinib cream
in patients with vitiligo were recently published in The Lancet. The two randomized Phase 3 trials in the TRuE-V pivotal program
evaluating ruxolitinib cream in patients with vitiligo are proceeding as planned, with results expected in 2021.
| Indication and status | ||
| ruxolitinib cream (JAK1/JAK2) | Atopic dermatitis: Phase 3 (TRuE-AD1, TRuE-AD2; primary endpoints met) Vitiligo: Phase 3 (TRuE-V1, TRuE-V2) | |
| INCB54707 (JAK1) | Hidradenitis suppurativa: Phase 2 | |
| parsaclisib (PI3K ) | Autoimmune hemolytic anemia: Phase 2 | |
| INCB00928 (ALK2) | Fibrodysplasia ossificans progressiva: Phase 2 in preparation |
Discovery and early development - key highlights
Based on emerging data from the LSD1 inhibitor program, development
of INCB59872 has been discontinued. Incyte's portfolio of other earlier-stage clinical candidates is summarized below.
| Modality | Candidates | |
| Small molecules | INCB01158 (ARG) 1 , INCB81776 (AXL/MER), epacadostat (IDO1), INCB86550 (PD-L1) | |
| Monoclonal antibodies 2 | INCAGN1876 (GITR), INCAGN2385 (LAG-3), INCAGN1949 (OX40), INCAGN2390 (TIM-3) | |
| Bispecific antibodies | MCLA-145 (PD-L1xCD137) 3 |
Potential therapies for patients with COVID-19
There are several ongoing studies of ruxolitinib, conducted
by Incyte alone or in collaboration with Novartis, and of baricitinib, conducted by Lilly, in patients with COVID-19. Initial results
from these trials are expected in the second half of 2020.
Incyte and Lilly have amended their agreement to enable Lilly
to move rapidly in the development and commercialization of baricitinib as a potential therapy for patients with COVID-19, moving
financial obligations post-approval.
| Status | |
| ruxolitinib (JAK1/JAK2) | COVID-19 associated cytokine storm: Phase 3 (RUXCOVID 1 ; 369-DEVENT) |
| baricitinib (JAK1/JAK2) 2 | Hospitalized patients with COVID-19: Phase 3 (ACTT-2 3 ; COV-BARRIER) |
Partnered - key highlights
In May, Incyte and Novartis announced the FDA approval of TabrectaTM
(capmatinib) for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation
that leads to MET exon 14 skipping (METex14) as detected by an FDA-approved test. Tabrecta was reviewed under Priority Review and
granted accelerated approval based on Phase 2 data in first-line and previously treated patients with METex14 mutated NSCLC.
In June, the Japanese Ministry of Health, Labour and Welfare
(MHLW) approved TabrectaTM (capmatinib) for METex14 mutation-positive advanced and/or recurrent unresectable NSCLC.
| Indication and status | ||
| baricitinib (JAK1/JAK2) 1 | Atopic dermatitis: Phase 3 (BREEZE-AD) Systemic lupus erythematosus: Phase 3 Severe alopecia areata: Phase 3 (BRAVE-AA1) | |
| capmatinib (MET) 2 | NSCLC (with MET exon 14 skipping mutations): Approved as Tabrecta in U.S. and Japan |
2020 Second Quarter Financial Results
financial measures presented in this press release for the three and six months ended June 30, 2020 and 2019 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
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.
Financial Highlights
| Financial Highlights | ||||||||||||||||
| (unaudited, in thousands, except per share amounts) | ||||||||||||||||
| Three Months Ended | Six Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Total GAAP revenue | $ | 688,043 | $ | 529,932 | $ | 1,256,550 | $ | 1,027,789 | ||||||||
| Total GAAP operating income (loss) | 230,773 | 98,612 | (433,231 | ) | 172,682 | |||||||||||
| Total Non-GAAP operating income (loss) | 288,514 | 151,219 | (320,966 | ) | 277,936 | |||||||||||
| GAAP net income (loss) | 290,298 | 105,318 | (430,344 | ) | 207,630 | |||||||||||
| Non-GAAP net income (loss) | 273,578 | 162,469 | (345,342 | ) | 297,011 | |||||||||||
| GAAP basic EPS | $ | 1.33 | $ | 0.49 | $ | (1.98 | ) | $ | 0.97 | |||||||
| Non-GAAP basic EPS | $ | 1.26 | $ | 0.76 | $ | (1.59 | ) | $ | 1.39 | |||||||
| GAAP diluted EPS | $ | 1.32 | $ | 0.48 | $ | (1.98 | ) | $ | 0.96 | |||||||
| Non-GAAP diluted EPS | $ | 1.24 | $ | 0.75 | $ | (1.59 | ) | $ | 1.37 |
| Revenue Details | ||||||||||||||||||||||||
| (unaudited, in thousands) | ||||||||||||||||||||||||
| Three Months Ended | Six Months Ended | |||||||||||||||||||||||
| June 30, | % | June 30, | % | |||||||||||||||||||||
| 2020 | 2019 | Change | 2020 | 2019 | Change | |||||||||||||||||||
| Revenues: | ||||||||||||||||||||||||
| Jakafi net product revenue | $ | 473,706 | $ | 409,506 | 16 | % | $ | 933,185 | $ | 785,117 | 19 | % | ||||||||||||
| Iclusig net product revenue | 22,798 | 24,391 | (7 | )% | 50,046 | 45,029 | 11 | % | ||||||||||||||||
| Pemazyre net product revenue | 3,786 | - | 3,786 | - | ||||||||||||||||||||
| Jakavi product royalty revenues | 66,217 | 56,895 | 16 | % | 122,550 | 102,466 | 20 | % | ||||||||||||||||
| Olumiant product royalty revenues | 25,830 | 19,140 | 35 | % | 51,277 | 35,177 | 46 | % | ||||||||||||||||
| Tabrecta product royalty revenues | 706 | - | 706 | - | ||||||||||||||||||||
| Product and royalty revenues | 593,043 | 509,932 | 16 | % | 1,161,550 | 967,789 | 20 | % | ||||||||||||||||
| Milestone and contract revenues | 95,000 | 20,000 | 375 | % | 95,000 | 60,000 | 58 | % | ||||||||||||||||
| Total GAAP revenues | $ | 688,043 | $ | 529,932 | 30 | % | $ | 1,256,550 | $ | 1,027,789 | 22 | % |
Product and Royalty Revenues
Product and royalty revenues for the three and six months ended June 30, 2020 increased 16% and 20%, respectively, over the prior
year comparative periods primarily as a result of increases in Jakafi net product revenues and higher product royalty revenues
from Jakavi and Olumiant. Jakafi net product revenues for the three and six months ended June 30, 2020 increased 16% and 19%, respectively,
over the prior year comparative periods, primarily driven by growth in patient demand across all indications.
| Operating Expense Summary | ||||||||||||||||||||||||
| (unaudited, in thousands) | ||||||||||||||||||||||||
| Three Months Ended | Six Months Ended | |||||||||||||||||||||||
| June 30, | % | June 30, | % | |||||||||||||||||||||
| 2020 | 2019 | Change | 2020 | 2019 | Change | |||||||||||||||||||
| GAAP cost of product revenues | $ | 33,364 | $ | 29,406 | 13 | % | $ | 60,683 | $ | 51,994 | 17 | % | ||||||||||||
| Non-GAAP cost of product revenues 1 | 27,734 | 23,846 | 16 | % | 49,444 | 40,874 | 21 | % | ||||||||||||||||
| GAAP research and development | 286,601 | 289,363 | (1 | )% | 1,371,888 | 559,908 | 145 | % | ||||||||||||||||
| Non-GAAP research and development 2 | 254,108 | 261,747 | (3 | )% | 1,310,682 | 504,870 | 160 | % | ||||||||||||||||
| GAAP selling, general and administrative | 117,998 | 105,943 | 11 | % | 229,146 | 229,926 | (0 | )% | ||||||||||||||||
| Non-GAAP selling, general and administrative 3 | 104,434 | 93,120 | 12 | % | 202,007 | 204,109 | (1 | )% | ||||||||||||||||
| GAAP change in fair value of acquisition-related contingent consideration | 6,054 | 6,608 | (8 | )% | 12,681 | 13,279 | (5 | )% | ||||||||||||||||
| Non-GAAP change in fair value of acquisition-related contingent consideration 4 | - | - | - | - | ||||||||||||||||||||
| GAAP collaboration loss sharing | 13,253 | - | 15,383 | - | ||||||||||||||||||||
| Non-GAAP collaboration loss sharing | 13,253 | - | 15,383 | - |
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.
2. Non-GAAP research and development expenses exclude
the cost of stock-based compensation.