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Incyte Reports 2020 Second Quarter Financial Results and Provides Updates on Key Clinical Programs

2020年08月04日 PM08:00
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WILMINGTON, Del.

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 Hervé 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.”

Portfolio Update

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.

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 + PI3Kδ)

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-naïve 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
(PI3Kδ)

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

 

1)

Clinical development of ruxolitinib in GVHD conducted in collaboration with Novartis

2)

Development of tafasitamab in collaboration with MorphoSys

3)

Retifanlimab licensed from MacroGenics; SCAC = squamous cell carcinoma of the anal canal

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
(PI3Kδ)

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 antibodies2

INCAGN1876 (GITR), INCAGN2385 (LAG-3), INCAGN1949 (OX40), INCAGN2390 (TIM-3)

 

Bispecific antibodies

MCLA-145 (PD-L1xCD137)3

 

1)

INCB01158 development in collaboration with Calithera

2)

Discovery collaboration with Agenus

3)

MCLA-145 development in collaboration with Merus

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 (RUXCOVID1; 369-DEVENT)

 

baricitinib (JAK1/JAK2)2

Hospitalized patients with COVID-19: Phase 3 (ACTT-23; COV-BARRIER)

 

1)

Sponsored by Incyte in the United States and by Novartis outside of the United States

2)

Worldwide rights to baricitinib licensed to Lilly: approved as Olumiant in multiple territories globally for certain patients with moderate-to-severe rheumatoid arthritis

3)

ACTT-2 agreement with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health

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

 

1)

Worldwide rights to baricitinib licensed to Lilly: approved as Olumiant in multiple territories globally for certain patients with moderate-to-severe rheumatoid arthritis

2)

Worldwide rights to capmatinib licensed to Novartis

2020 Second Quarter Financial Results

The 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 peers.

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.

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

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

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