Total product and royalty revenues of $569 million (+24% vs Q1 2019) for the quarter ended March 31, 2020; Jakafi® (ruxolitinib) revenues of $459 million in Q1 2020 (+22% vs Q1 2019).
WILMINGTON, Del.–(BUSINESS WIRE)–$INCY #earnings–Incyte (Nasdaq: INCY) today reports 2020 first quarter financial results, and provides a status update on the Company’s development portfolio.
“Our strong first quarter results highlight continued revenue momentum, led by robust demand across all three indications for Jakafi® (ruxolitinib),” stated Hervé Hoppenot, Chief Executive Officer, Incyte. “As we navigate this unprecedented and uncertain time, we have implemented numerous initiatives as we seek to ensure continuity of patient care. We are continuing to execute on our goals, and we were very pleased to announce the FDA approval of Pemazyre™ (pemigatinib), the first of three potential product approvals that we expect to announce in 2020. The FDA review of the capmatinib NDA and tafasitamab BLA are proceeding as expected and, following positive results from our Phase 3 TRuE-AD development program in atopic dermatitis, we are also on track to submit the NDA for ruxolitinib cream at the end of 2020, all of which positions us for what I expect to be a transformational year.”
COVID-19
Commercial, Supply and Clinical & Regulatory Impact
While it is currently not possible to predict the overall long-term impact of the COVID-19 pandemic on Incyte’s business, to-date, there has been no impact on the commercial side of the business, and Incyte currently has ample commercial and clinical supply of our medicines to meet the needs of patients receiving Incyte’s approved medicines and those participating in global clinical trials. Incyte’s manufacturing processes are proceeding as usual, with increased manufacturing efforts for ruxolitinib in place to respond to the COVID-19 pandemic and study requests. Incyte continues to move forward with its global clinical trials, and late-stage programs remain broadly on track, although short-term effects may continue to emerge. For example, while ongoing monitoring of already-enrolled patients is expected to continue, new patient recruitment in certain clinical studies may be impacted. The impact on clinical trials may also vary by disease state and by severity of disease, as well as by geography, as some regions are more adversely impacted.
Ruxolitinib and baricitinib as potential therapies for patients with COVID-19
Incyte has initiated a Phase 3 clinical trial (RUXCOVID) to evaluate the efficacy and safety of ruxolitinib plus standard-of-care (SoC), compared to SoC therapy alone, in patients with COVID-19 associated cytokine storm. The collaborative study is sponsored by Incyte in the United States and by Novartis outside of the United States.
Incyte is also opening a second Phase 3 clinical trial in the United States to evaluate the efficacy and safety of ruxolitinib plus SoC, compared to SoC therapy alone, in COVID-19 patients on mechanical ventilation and who have acute respiratory distress syndrome (ARDS), a type of respiratory failure characterized by rapid onset of widespread inflammation in the lungs.
Additionally, Incyte has launched an emergency Expanded Access Program in the United States to allow eligible patients with COVID-19 associated cytokine storm to receive ruxolitinib.
In April, Lilly announced it has entered into an agreement with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to study baricitinib as an arm in NIAID’s Adaptive COVID-19 Treatment Trial. The study will investigate the efficacy and safety of baricitinib as a potential treatment for hospitalized patients diagnosed with COVID-19 in the US, and Lilly is also planning a study expansion to include Europe and Asia.
Portfolio Update
LIMBER – key highlights
Key LIMBER development programs, including the once-a-day (QD) formulation of ruxolitinib, and the ongoing and planned ruxolitinib combinations with parsaclisib (PI3Kδ), PIM, BET and ALK2 are currently on track.
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Indication and status |
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Once-a-day ruxolitinib |
Myelofibrosis and polycythemia vera: clinical pharmacology studies |
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ruxolitinib + parsaclisib |
Refractory myelofibrosis: Phase 3 in preparation |
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ruxolitinib + INCB53914 |
Refractory myelofibrosis: Phase 2 |
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ruxolitinib + INCB57643 |
Refractory myelofibrosis: Phase 2 in preparation |
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ruxolitinib + INCB00928 |
Myelofibrosis: Phase 2 in preparation |
Oncology beyond MPNs – key highlights
In April, the FDA approved Pemazyre, Incyte’s selective fibroblast growth factor receptor (FGFR) inhibitor, for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or other rearrangement as detected by an FDA-approved test. Pemazyre was reviewed under Breakthrough Therapy designation and granted accelerated approval based on overall response rate and duration of response. The marketing authorization application (MAA) seeking approval for pemigatinib in Europe is under review by the European Medicines Agency (EMA).
Delays in data collection and validation, caused by COVID-19 related disruption, mean that data from the FIGHT-201 clinical trial of pemigatinib in patients with bladder cancer are now expected to be presented at a medical conference in early 2021; all other clinical trials of pemigatinib are currently progressing as expected.
Data from the Phase 3 REACH 2 trial of ruxolitinib versus best available therapy (BAT) in patients with steroid-refractory acute graft-versus-host disease (GVHD) have been published in The New England Journal of Medicine and are also expected to be presented at the 46th annual meeting of the European Society for Blood and Marrow Transplantation (EBMT) in August 30-September 2, 2020 (postponed from March 22-25, 2020). The Phase 3 REACH 3 trial of ruxolitinib versus BAT in patients with steroid-refractory chronic GVHD has completed recruitment and results are expected in the second half of 2020.
The collaboration and license agreement with MorphoSys for the development and commercialization of tafasitamab became effective in March. In February, the FDA granted Priority Review for tafasitamab in combination with lenalidomide for the treatment of relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL), and set a PDUFA goal date of August 30, 2020.
Preparations are ongoing to initiate the Phase 3 POD1UM-304 trial of retifanlimab (formerly INCMGA0012) in combination with platinum-based chemotherapy as a first-line treatment for patients with non-small cell lung cancer (NSCLC). Incyte no longer plans to pursue the Phase 3 POD1UM-301 trial of retifanlimab in combination with chemoradiation therapy (CRT) in participants with unresectable, Stage III NSCLC.
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Indication and status |
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ruxolitinib |
Steroid-refractory chronic GVHD: Phase 3 (REACH3)1 |
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itacitinib |
Treatment-naïve chronic GVHD: Phase 3 (GRAVITAS-309) |
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pemigatinib |
Cholangiocarcinoma: Phase 2 (FIGHT-202), Phase 3 (FIGHT-302); MAA under review |
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tafasitamab (CD19)2 |
r/r DLBCL: Phase 2 (L-MIND); Phase 3 (B-MIND); BLA under review |
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parsaclisib |
Follicular lymphoma: Phase 2 (CITADEL-203) |
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retifanlimab |
MSI-high endometrial cancer: Phase 2 (POD1UM-101) |
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
Inflammation and Autoimmunity (IAI) – key highlights
In April, safety and efficacy data from the two Phase 3 trials in the TRuE-AD program evaluating ruxolitinib cream in mild-to-moderate atopic dermatitis were presented at the Revolutionizing Atopic Dermatitis (RAD) virtual symposium. The 44-week long-term safety and efficacy portion of both the TRuE-AD1 and TRuE-AD2 trials are ongoing and the NDA submission is expected before the end of 2020.
The two Phase 3 trials in the TRuE-V pivotal program evaluating ruxolitinib cream in patients with vitiligo are currently proceeding as planned, and results are expected in 2021.
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Indication and status |
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ruxolitinib cream |
Atopic dermatitis: Phase 3 (TRuE-AD1, TRuE-AD2; primary endpoints met) |
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INCB54707 |
Hidradenitis suppurativa: Phase 2 |
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parsaclisib |
Autoimmune hemolytic anemia: Phase 2 |
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INCB00928 |
Fibrodysplasia ossificans progressiva: Phase 2 in preparation |
Discovery and early development – key highlights
Based on emerging data from the FGFR4 inhibitor program, development of INCB62079 has been discontinued because of insufficient efficacy in the target patient population. Incyte’s portfolio of other earlier-stage clinical candidates is summarized below.
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Financial Highlights |
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Financial Highlights |
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Three Months Ended |
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2020 |
|
2019 |
|||||
|
Total GAAP revenue |
$ |
568,507 |
|
$ |
497,857 |
||
|
Total GAAP operating income (loss) |
|
(664,004 |
) |
|
74,070 |
||
|
Total Non-GAAP operating income (loss) |
|
(609,480 |
) |
|
126,717 |
||
|
GAAP net income (loss) |
|
(720,642 |
) |
|
102,312 |
||
|
Non-GAAP net income (loss) |
|
(618,920 |
) |
|
134,542 |
||
|
GAAP basic EPS |
$ |
(3.33 |
) |
$ |
0.48 |
||
|
Non-GAAP basic EPS |
$ |
(2.86 |
) |
$ |
0.63 |
||
|
GAAP diluted EPS |
$ |
(3.33 |
) |
$ |
0.47 |
||
|
Non-GAAP diluted EPS |
$ |
(2.86 |
) |
$ |
0.62 |
||
|
Revenue Details |
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Revenue Details |
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Three Months Ended |
% |
||||||||
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2020 |
|
2019 |
Change |
||||||
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Revenues: |
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Jakafi net product revenue |
$ |
459,479 |
$ |
375,611 |
22 |
% |
|||
|
Iclusig net product revenue |
|
27,248 |
|
20,638 |
32 |
% |
|||
|
Jakavi product royalty revenues |
|
56,333 |
|
45,571 |
24 |
% |
|||
|
Olumiant product royalty revenues |
|
25,447 |
|
16,037 |
59 |
% |
|||
|
Product and royalty revenues |
|
568,507 |
|
457,857 |
24 |
% |
|||
|
Milestone and contract revenues |
|
– |
|
40,000 |
|||||
|
Total GAAP revenues |
$ |
568,507 |
$ |
497,857 |
14 |
% |
|||
Product and Royalty Revenues Product and royalty revenues for the quarter ended March 31, 2020 increased 24% over the prior year comparative period as a result of increases in Jakafi and Iclusig net product revenues and higher product royalty revenues from Jakavi and Olumiant. Jakafi net product revenues for the quarter ended March 31, 2020 increased 22% over the prior year comparative period, primarily driven by growth in patient demand across all indications.
Other Financial Information
Operating income (loss) GAAP and Non-GAAP operating income (loss) for the quarter ended March 31, 2020 decreased compared to the same period in 2019 primarily due to upfront consideration related to our collaborative agreement with MorphoSys, partially offset by the growth in product and royalty revenues.
Cash, cash equivalents and marketable securities position As of March 31, 2020 and December 31, 2019, cash, cash equivalents and marketable securities totaled $1.3 billion and $2.1 billion, respectively. The decrease reflects the upfront payment and stock purchase related to our collaborative agreement with MorphoSys.
2020 Financial Guidance
The R&D expense guidance now includes the expenses related to Incyte’s share of tafasitamab development costs under the MorphoSys collaboration, but excludes $805 million of upfront consideration paid under the MorphoSys collaboration.
For full financial report, please visit Incyte website.