Incyte Reports 2021 Fourth Quarter and Year-End Financial Results, and Provides 2022 Financial Guidance and Updates on Key Clinical Programs
Incyte reported Q4 2021 revenues of $862.9 million, up 9% year-over-year, with total product and royalty revenues of $813 million (+20%) and Jakafi revenues of $592 million (+15%). The company projects Jakafi revenues of $2.3 to $2.4 billion for 2022. Incyte successfully launched Opzelura in atopic dermatitis, treating nearly 19,000 patients by year-end. The FDA has accepted a supplemental application for Opzelura in vitiligo, with a decision expected by April 18, 2022. The company ended 2021 with $2.3 billion in cash and marketable securities.
- Total product and royalty revenues increased 20% to $813 million in Q4 2021.
- Jakafi revenues for Q4 2021 were $592 million, reflecting a 15% increase.
- Successful launch of Opzelura in atopic dermatitis, treating nearly 19,000 patients.
- 2022 guidance for Jakafi revenue set at $2.3 - $2.4 billion.
- Strong cash position of $2.3 billion at the end of 2021.
- GAAP operating income decreased compared to Q4 2020 due to increased expenses.
- Research and development costs increased, impacting profitability.
- Withdrawal of the NDA for parsaclisib in the U.S. for certain lymphoma indications.
-
Total product and royalty revenues of
(+$813 million 20% ) in Q4’21 and (+$2.89 1 billion17% ) in FY’21 -
Jakafi® (ruxolitinib) net product revenues of
(+$592 million 15% ) in Q4’21 and (+$2.13 5 billion10% ) in FY’21; Jakafi guidance range of to$2.3 for 2022$2.4 billion -
Successful
U.S. launch of Opzelura™ (ruxolitinib) cream in atopic dermatitis with nearly 19,000 patients treated from launch (October 11 th) through the end of the year -
Vitiligo is the next substantial growth opportunity for ruxolitinib cream – under Priority Review in the
U.S. and under review inEurope
Conference Call and Webcast Scheduled Today at
“2021 was a year of important accomplishments for
Portfolio Updates
MPNs and GVHD – key highlights
Axatilimab (anti-CSF-1R monoclonal antibody) in chronic GVHD: In December, updated positive data from the Phase 1/2 trial evaluating axatilimab as a monotherapy in patients with recurrent or refractory chronic GVHD despite two or more prior lines of therapy were presented at ASH. A
LIMBER (Leadership In MPNs BEyond Ruxolitinib) program: The new drug application (NDA) for once-daily ruxolitinib (QD) is on track for submission in the first half of this year. Two Phase 3 trials of ruxolitinib in combination with parsaclisib as a first-line therapy for patients with MF and as a therapy for MF patients with a suboptimal response to ruxolitinib monotherapy are both underway. Combination trials of ruxolitinib with INCB57643 (BET) and INCB00928 (ALK2) are in preparation with initial data expected later this year.
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Indication and status |
QD ruxolitinib
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Myelofibrosis, polycythemia vera and GVHD: clinical pharmacology studies |
ruxolitinib + parsaclisib
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Myelofibrosis: Phase 3 (first-line therapy) (LIMBER‑313)
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ruxolitinib + INCB57643
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Myelofibrosis: Phase 2 in preparation
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ruxolitinib + INCB00928
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Myelofibrosis: Phase 2 in preparation
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ruxolitinib + CK08041
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Myelofibrosis: PoC in preparation |
itacitinib (JAK1) |
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Treatment-naïve chronic GVHD: Phase 2/3 (GRAVITAS‑309) |
axatilimab (anti-CSF-1R)2 |
|
Chronic GVHD (third-line plus therapy): Pivotal Phase 2 (AGAVE-201) |
1 Development collaboration with Cellenkos, Inc. |
2 Clinical development of axatilimab in GVHD conducted in collaboration with Syndax Pharmaceuticals. |
Other Hematology/Oncology – key highlights
Parsaclisib in warm autoimmune hemolytic anemia (wAIHA): Following positive Phase 2 results, a Phase 3 randomized trial evaluating the efficacy and safety of parsaclisib in adults with wAIHA has been initiated. There are currently no FDA approved treatments for wAIHA in
Parsaclisib in non-Hodgkin lymphomas: In January,
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Indication and status1 |
pemigatinib
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CCA: Phase 3 (FIGHT‑302)
NSCLC: Phase 2 in preparation |
tafasitamab (CD19)2 |
|
Relapsed or refractory DLBCL: Phase 2 (L-MIND); Phase 3 (B-MIND) First-line DLBCL: Phase 3 (frontMIND) Relapsed or refractory FL and Relapsed or refractory MZL: Phase 3 (inMIND) Relapsed or refractory B-cell malignancies: PoC (topMIND) with parsaclisib (PI3Kδ) Relapsed or refractory B-cell malignancies: PoC with lenalidomide and plamotamab in preparation3 |
parsaclisib
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Autoimmune hemolytic anemia: Phase 3 (PATHWAY) |
retifanlimab
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SCAC: Phase 3 (POD1UM‑303)
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1 CCA = cholangiocarcinoma; DLBCL = diffuse large B-cell lymphoma; SCAC = squamous cell anal carcinoma; FL = follicular lymphoma; MZL = marginal zone lymphoma; MCL = mantle cell lymphoma; CLL = chronic lymphocytic leukemia |
2 Development of tafasitamab in collaboration with MorphoSys. |
3 Clinical collaboration with MorphoSys and Xencor, Inc. to investigate the combination of tafasitamab plus lenalidomide in combination with Xencor’s CD20xCD3 XmAb bispecific antibody, plamotamab. |
4 Retifanlimab licensed from MacroGenics. |
Inflammation and Autoimmunity (IAI) – key highlights
Dermatology
Opzelura launch in AD in the
Ruxolitinib cream in vitiligo in the
Ruxolitinib cream in pediatric AD: A Phase 3 randomized trial (TRuE-AD3) evaluating the efficacy and safety of ruxolitinib cream in children ages two to twelve years old with AD is currently ongoing.
Ruxolitinib cream in chronic hand eczema (CHE):
INCB54707 (JAK1) in multiple dermatology indications: Incyte’s growing dermatology portfolio includes INCB54707, a JAK1 specific inhibitor, which is being evaluated across multiple indications. Phase 2 trials are currently ongoing in vitiligo, hidradenitis suppurativa and prurigo nodularis, with data in vitiligo and hidradenitis suppurativa expected later this year.
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Indication and status |
ruxolitinib cream1
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Atopic dermatitis: Phase 3 pediatric study (TRuE-AD3)
Chronic hand eczema: Phase 3 (TRuE-CHE1) being initiated |
INCB54707 (JAK1) |
|
Hidradenitis suppurativa: Phase 2b
Prurigo nodularis: Phase 2 |
1 Novartis’ rights for ruxolitinib outside of |
Discovery and early development – key highlights
Incyte’s portfolio of other earlier-stage clinical candidates is summarized below.
Oral PD-L1 Program: In November,
MCLA-145 (CD137/PD-L1 bispecific antibody): In January,
Modality |
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Candidates |
Small molecules |
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INCB81776 (AXL/MER), epacadostat (IDO1), INCB86550 (PD-L1), INCB99280 (PD-L1), INCB99318 (PD-L1), INCB106385 (A2A/A2B) |
Monoclonal antibodies1 |
|
INCAGN1876 (GITR), INCAGN2385 (LAG‑3), INCAGN1949 (OX40), INCAGN2390 (TIM‑3), INCA00186 (CD73) |
1 Discovery collaboration with Agenus. |
Partnered – key highlights
Baricitinib in alopecia areata (AA): Regulatory applications for baricitinib as a treatment for alopecia areata have been submitted in the
Baricitinib in AD in the
Baricitinib in systemic lupus erythematosus (SLE): In January,
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Indication and status |
ruxolitinib (JAK1/JAK2)1 |
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Acute and chronic GVHD: MAA and J-NDA under review |
baricitinib (JAK1/JAK2)2 |
|
Atopic dermatitis: Phase 3 (BREEZE-AD); approved in EU and |
capmatinib (MET)3 |
|
NSCLC (with MET exon 14 skipping mutations): Approved as Tabrecta in |
1 Jakavi (ruxolitinib) licensed to Novartis ex-US. |
2 Worldwide rights to baricitinib licensed to Lilly: approved as Olumiant in multiple territories globally for certain patients with moderate-to-severe rheumatoid arthritis; approved as Olumiant in EU and |
3 Worldwide rights to capmatinib licensed to Novartis. |
2021 Fourth Quarter and Year-End Financial Results
The financial measures presented in this press release for the quarter and year ended
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 |
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(unaudited, in thousands, except per share amounts) |
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Three Months Ended |
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Twelve Months Ended |
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2021 |
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2020 |
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2021 |
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2020 |
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Total GAAP revenue |
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$ |
862,853 |
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|
$ |
789,509 |
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$ |
2,986,267 |
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$ |
2,666,702 |
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Total GAAP operating income (loss) |
|
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110,734 |
|
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|
164,229 |
|
|
|
585,777 |
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(263,676 |
) |
Total Non-GAAP operating income (loss) |
|
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166,013 |
|
|
|
218,469 |
|
|
|
825,032 |
|
|
|
(40,878 |
) |
GAAP (benefit) provision for income taxes |
|
|
(443,831 |
) |
|
|
18,252 |
|
|
(378,137 |
) |
|
|
63,479 |
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GAAP net income (loss) |
|
|
563,851 |
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|
149,850 |
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|
948,581 |
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|
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(295,697 |
) |
Non-GAAP net income (loss) |
|
|
22,565 |
|
|
|
204,773 |
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|
611,978 |
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(90,510 |
) |
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GAAP basic EPS |
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$ |
2.55 |
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$ |
0.68 |
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$ |
4.30 |
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|
$ |
(1.36 |
) |
Non-GAAP basic EPS |
|
$ |
0.10 |
|
|
$ |
0.93 |
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$ |
2.78 |
|
|
$ |
(0.42 |
) |
GAAP diluted EPS |
|
$ |
2.54 |
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$ |
0.68 |
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$ |
4.27 |
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$ |
(1.36 |
) |
Non-GAAP diluted EPS |
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$ |
0.10 |
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$ |
0.93 |
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$ |
2.76 |
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$ |
(0.42 |
) |
Revenue Details
Revenue Details |
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(unaudited, in thousands) |
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Three Months Ended |
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Twelve Months Ended |
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% |
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% |
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2021 |
|
2020 |
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Change |
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2021 |
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2020 |
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Change |
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Net product revenues: |
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Jakafi |
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$ |
592,370 |
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$ |
516,882 |
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$ |
2,134,508 |
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$ |
1,937,850 |
|
|
Iclusig |
|
|
27,039 |
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28,576 |
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(5)% |
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|
109,395 |
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105,002 |
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Pemazyre |
|
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19,607 |
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14,009 |
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68,531 |
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25,884 |
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Minjuvi |
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4,354 |
|
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— |
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NM |
|
|
4,910 |
|
|
— |
|
NM |
Opzelura |
|
|
4,668 |
|
|
— |
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NM |
|
|
4,668 |
|
|
— |
|
NM |
Royalty revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Jakavi |
|
|
95,696 |
|
|
87,046 |
|
|
|
|
337,991 |
|
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277,902 |
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Olumiant |
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66,000 |
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30,996 |
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|
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220,875 |
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110,920 |
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Tabrecta |
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3,119 |
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2,000 |
|
|
|
|
10,389 |
|
|
4,144 |
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|
Total product and royalty revenues |
|
|
812,853 |
|
|
679,509 |
|
|
|
|
2,891,267 |
|
|
2,461,702 |
|
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Milestone and contract revenues |
|
|
50,000 |
|
|
110,000 |
|
NM |
|
|
95,000 |
|
|
205,000 |
|
NM |
Total GAAP revenues |
|
$ |
862,853 |
|
$ |
789,509 |
|
|
|
$ |
2,986,267 |
|
$ |
2,666,702 |
|
|
NM = not meaningful |
Product and Royalty Revenues Product and royalty revenues for the quarter and year ended
Operating Expenses
Operating Expense Summary |
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(unaudited, in thousands) |
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Three Months Ended |
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Twelve Months Ended |
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% |
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% |
||||||||
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|
2021 |
|
2020 |
|
Change |
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2021 |
|
2020 |
|
Change |
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GAAP cost of product revenues |
|
$ |
43,874 |
|
$ |
36,323 |
|
|
|
$ |
150,991 |
|
$ |
131,328 |
|
|
Non-GAAP cost of product revenues1 |
|
|
37,886 |
|
|
30,693 |
|
|
|
|
127,749 |
|
|
108,830 |
|
|
GAAP research and development |
|
|
472,827 |
|
|
405,945 |
|
|
|
|
1,458,179 |
|
|
2,215,942 |
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(34)% |
Non-GAAP research and development2 |
|
|
442,693 |
|
|
375,770 |
|
|
|
|
1,343,863 |
|
|
2,095,586 |
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(36)% |
GAAP selling, general and administrative |
|
|
226,202 |
|
|
166,988 |
|
|
|
|
739,560 |
|
|
516,922 |
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|
Non-GAAP selling, general and administrative3 |
|
|
208,718 |
|
|
152,148 |
|
|
|
|
652,604 |
|
|
460,363 |
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GAAP change in fair value of acquisition-related contingent consideration |
|
|
1,673 |
|
|
3,595 |
|
(53)% |
|
|
14,741 |
|
|
23,385 |
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(37)% |
Non-GAAP change in fair value of acquisition-related contingent consideration4 |
|
|
— |
|
|
— |
|
|
|
|
— |
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— |
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GAAP collaboration loss sharing |
|
|
7,543 |
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|
12,429 |
|
(39)% |
|
|
37,019 |
|
|
42,801 |
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(14)% |
1 Non-GAAP cost of product revenues excludes the amortization of licensed intellectual property for Iclusig relating to the acquisition of the European business of |
2 Non-GAAP research and development expenses exclude the cost of stock-based compensation. |
3 Non-GAAP selling, general and administrative expenses exclude the cost of stock-based compensation and legal settlements. |
4 Non-GAAP change in fair value of acquisition-related contingent consideration is null. |
Research and development expenses GAAP and Non-GAAP research and development expense for the quarter ended
For the year ended
Selling, general and administrative expenses GAAP and Non-GAAP selling, general and administrative expenses for the quarter ended
Other Financial Information
Operating income (loss) GAAP and Non-GAAP operating income for the quarter ended
(Benefit) provision for income taxes The company released the valuation allowance on the majority of its
Cash, cash equivalents and marketable securities position As of
2022 Financial Guidance
Guidance does not include revenue from Opzelura or the impact of any potential future strategic transactions.
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Current |
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Jakafi net product revenues |
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Other Hematology/Oncology net product revenues(1) |
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GAAP Cost of product revenues |
6 – |
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Non-GAAP Cost of product revenues(2) |
5 – |
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GAAP Selling, general and administrative expenses |
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Non-GAAP Selling, general and administrative expenses(3) |
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1 Pemazyre in the |
2 Adjusted to exclude the amortization of licensed intellectual property for Iclusig relating to the acquisition of the European business of |
3 Adjusted to exclude the estimated cost of stock-based compensation. |
Conference Call and Webcast Information
If you are unable to participate, a replay of the conference call will be available for 90 days. The replay dial-in number for
The conference call will also be webcast live and can be accessed at investor.incyte.com.
About
About Jakafi® (ruxolitinib)
Jakafi is a first-in-class JAK1/JAK2 inhibitor approved by the
Jakafi is also indicated for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea, in adults with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF and for treatment of steroid-refractory acute GVHD in adult and pediatric patients 12 years and older.
Jakafi is marketed by
About Opzelura™ (ruxolitinib) Cream
Opzelura (ruxolitinib) cream is a novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib, is the first and only topical JAK inhibitor approved for use in
In
Opzelura is a trademark of
About Monjuvi®/Minjuvi® (tafasitamab)
Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP).
In
In
Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in several ongoing combination trials.
Minjuvi® and Monjuvi® are registered trademarks of MorphoSys AG. Tafasitamab is co-marketed by
XmAb® is a registered trademark of Xencor, Inc.
About Pemazyre® (pemigatinib)
Pemazyre is a kinase inhibitor indicated in
In
In
Pemazyre is a potent, selective, oral inhibitor of FGFR isoforms 1, 2 and 3 which, in preclinical studies, has demonstrated selective pharmacologic activity against cancer cells with FGFR alterations.
Pemazyre is marketed by
Pemazyre is a trademark of
* Pemazyre® (pemigatinib) [Package Insert].
About Iclusig® (ponatinib) tablets
Ponatinib (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
Click here to view the Iclusig EU Summary of Medicinal Product Characteristics.
Forward-Looking Statements
Except for the historical information set forth herein, the matters set forth in this release contain predictions, estimates and other forward-looking statements, including any discussion of the following: Incyte’s financial guidance for 2022, including its expectations regarding sales of Jakafi; Incyte’s expectations with regard to the regulatory submissions seeking approval of ruxolitinib cream in vitiligo; Incyte’s expectations with regard to filing an NDA for once-daily ruxolitinib; Incyte’s expectations with respect to Opzelura, including the Company’s ongoing discussions with payers; Incyte’s expectations regarding ongoing clinical trials and clinical trials to be initiated, including trials of axatilimab in chronic GVHD, the LIMBER program, a phase 3 clinical trials of parsaclisib in warm autoimmune hemolytic anemia, Phase 2 trials of pemigatinib in glioblastoma and non-small cell lung cancer, a proof of concept trial of tafasitamab in combination with lenalidomide and plamotamab in relapsed/refractory B-cell malignancies, phase 3 trials for ruxolitinib cream in pediatric AD and chronic hand eczema, and a Phase 2 trial of INCB00928 in fibrodysplasia ossificans progressiva; Incyte’s life cycle management strategy for ruxolitinib cream; Incyte’s expectations with regard to its ongoing partnership with Merus; and Incyte’s expectations with regard to regulatory submissions for baricitinib and capmatinib.
These forward-looking statements are based on the Company’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials and the ability to enroll subjects in accordance with planned schedules; the effects of the COVID 19 pandemic and measures to address the pandemic on the Company’s clinical trials, supply chain and other third-party providers, sales and marketing efforts and business, development and discovery operations; determinations made by the FDA, EMA, and other regulatory agencies; the Company’s dependence on its relationships with and changes in the plans of its collaboration partners; the efficacy or safety of the Company’s products and the products of the Company’s collaboration partners; the acceptance of the Company’s products and the products of the Company’s collaboration partners in the marketplace; market competition; unexpected variations in the demand for the Company’s products and the products of the Company’s collaboration partners; the effects of announced or unexpected price regulation or limitations on reimbursement or coverage for the Company’s products and the products of the Company’s collaboration partners; sales, marketing, manufacturing and distribution requirements, including the Company’s and its collaboration partners’ ability to successfully commercialize and build commercial infrastructure for newly approved products and any additional products that become approved; greater than expected expenses, including expenses relating to litigation or strategic activities; and other risks detailed in the Company’s reports filed with the
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
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(unaudited, in thousands, except per share amounts) |
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Three Months Ended |
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Twelve Months Ended |
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2021 |
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2020 |
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2021 |
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2020 |
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GAAP |
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GAAP |
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Revenues: |
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Product revenues, net |
|
$ |
648,038 |
|
|
$ |
559,467 |
|
|
$ |
2,322,012 |
|
|
$ |
2,068,736 |
|
Product royalty revenues |
|
|
164,815 |
|
|
|
120,042 |
|
|
|
569,255 |
|
|
|
392,966 |
|
Milestone and contract revenues |
|
|
50,000 |
|
|
|
110,000 |
|
|
|
95,000 |
|
|
|
205,000 |
|
Total revenues |
|
|
862,853 |
|
|
|
789,509 |
|
|
|
2,986,267 |
|
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|
2,666,702 |
|
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Costs and expenses: |
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|
|
|
||||
Cost of product revenues (including definite-lived intangible amortization) |
|
|
43,874 |
|
|
|
36,323 |
|
|
|
150,991 |
|
|
|
131,328 |
|
Research and development |
|
|
472,827 |
|
|
|
405,945 |
|
|
|
1,458,179 |
|
|
|
2,215,942 |
|
Selling, general and administrative |
|
|
226,202 |
|
|
|
166,988 |
|
|
|
739,560 |
|
|
|
516,922 |
|
Change in fair value of acquisition-related contingent consideration |
|
|
1,673 |
|
|
|
3,595 |
|
|
|
14,741 |
|
|
|
23,385 |
|
Collaboration loss sharing |
|
|
7,543 |
|
|
|
12,429 |
|
|
|
37,019 |
|
|
|
42,801 |
|
Total costs and expenses |
|
|
752,119 |
|
|
|
625,280 |
|
|
|
2,400,490 |
|
|
|
2,930,378 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Income (loss) from operations |
|
|
110,734 |
|
|
|
164,229 |
|
|
|
585,777 |
|
|
|
(263,676 |
) |
Other income (expense), net |
|
|
5,716 |
|
|
|
4,810 |
|
|
|
10,647 |
|
|
|
23,206 |
|
Interest expense |
|
|
(752 |
) |
|
|
(428 |
) |
|
|
(1,908 |
) |
|
|
(2,174 |
) |
Unrealized (loss) gain on long term investments |
|
|
4,322 |
|
|
|
(509 |
) |
|
|
(24,072 |
) |
|
|
10,426 |
|
Income (loss) before (benefit) provision for income taxes |
|
|
120,020 |
|
|
|
168,102 |
|
|
|
570,444 |
|
|
|
(232,218 |
) |
(Benefit) provision for income taxes |
|
|
(443,831 |
) |
|
|
18,252 |
|
|
|
(378,137 |
) |
|
|
63,479 |
|
Net income (loss) |
|
$ |
563,851 |
|
|
$ |
149,850 |
|
|
$ |
948,581 |
|
|
$ |
(295,697 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net income (loss) per share: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Basic |
|
$ |
2.55 |
|
|
$ |
0.68 |
|
|
$ |
4.30 |
|
|
$ |
(1.36 |
) |
Diluted |
|
$ |
2.54 |
|
|
$ |
0.68 |
|
|
$ |
4.27 |
|
|
$ |
(1.36 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Shares used in computing net income (loss) per share: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Basic |
|
|
220,984 |
|
|
|
219,239 |
|
|
|
220,428 |
|
|
|
218,073 |
|
Diluted |
|
|
221,989 |
|
|
|
221,228 |
|
|
|
222,074 |
|
|
|
218,073 |
|
|
||||||
CONDENSED CONSOLIDATED BALANCE SHEETS |
||||||
(unaudited, in thousands) |
||||||
|
|
|||||
|
|
|
|
|||
|
2021 |
|
2020 |
|||
ASSETS |
|
|||||
Cash, cash equivalents and marketable securities |
$ |
2,348,192 |
$ | 1,801,377 |
||
Accounts receivable |
|
616,300 |
481,994 |
|||
Property and equipment, net |
|
723,920 |
559,625 |
|||
Finance lease right-of-use assets, net |
|
27,548 |
28,451 |
|||
Inventory |
|
56,938 |
35,973 |
|||
Prepaid expenses and other assets |
|
165,302 |
101,259 |
|||
Long term investments |
|
221,266 |
222,301 |
|||
Other intangible assets, net |
|
150,755 |
172,291 |
|||
|
|
155,593 |
155,593 |
|||
Deferred income tax asset |
|
467,538 |
2,054 |
|||
Total assets |
$ |
4,933,352 |
$ | 3,560,918 |
||
|
|
|||||
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|||||
Accounts payable, accrued expenses and other liabilities |
$ |
885,081 |
$ | 648,793 |
||
Finance lease liabilities |
|
34,267 |
34,857 |
|||
Acquisition-related contingent consideration |
|
244,000 |
266,000 |
|||
Stockholders’ equity |
|
3,770,004 |
2,611,268 |
|||
Total liabilities and stockholders’ equity |
$ |
4,933,352 |
$ | 3,560,918 |
|
||||||||||||||||
RECONCILIATION OF GAAP NET INCOME (LOSS) TO SELECTED NON-GAAP ADJUSTED INFORMATION |
||||||||||||||||
(unaudited, in thousands, except per share amounts) |
||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
Three Months Ended |
|
Twelve Months Ended |
||||||||||||
|
|
|
|
|
||||||||||||
|
|
2021 |
|
2020 |
|
2021 |
|
2020 |
||||||||
GAAP Net Income (Loss) |
|
$ |
563,851 |
|
|
$ |
149,850 |
|
$ |
948,581 |
|
|
$ |
(295,697 |
) |
|
Adjustments1: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Non-cash stock compensation from equity awards (R&D)2 |
|
|
30,134 |
|
|
|
30,175 |
|
|
|
114,316 |
|
|
|
120,356 |
|
Non-cash stock compensation from equity awards (SG&A)2 |
|
|
17,484 |
|
|
|
14,840 |
|
|
|
66,984 |
|
|
|
56,559 |
|
Non-cash stock compensation from equity awards (COGS)2 |
|
|
604 |
|
|
|
246 |
|
|
|
1,706 |
|
|
|
962 |
|
Non-cash interest3 |
|
|
109 |
|
|
|
66 |
|
|
|
181 |
|
|
|
683 |
|
Changes in fair value of equity investments4 |
|
|
(4,322 |
) |
|
|
509 |
|
|
|
24,072 |
|
|
|
(10,426 |
) |
Amortization of acquired product rights5 |
|
|
5,384 |
|
|
|
5,384 |
|
|
|
21,536 |
|
|
|
21,536 |
|
Change in fair value of contingent consideration6 |
|
|
1,673 |
|
|
|
3,595 |
|
|
|
14,741 |
|
|
|
23,385 |
|
Legal settlements7 |
|
|
— |
|
|
|
— |
|
|
|
19,972 |
|
|
|
— |
|
Non-operating tax adjustments8 |
|
|
(568,988 |
) |
|
|
— |
|
|
|
(568,988 |
) |
|
|
— |
|
Tax effect of Non-GAAP pre-tax adjustments9 |
|
|
(23,364 |
) |
|
|
108 |
|
|
|
(31,123 |
) |
|
|
(7,868 |
) |
Non-GAAP Net Income (Loss) |
|
$ |
22,565 |
|
|
$ |
204,773 |
|
|
$ |
611,978 |
|
|
$ |
(90,510 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Non-GAAP net income (loss) per share: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Basic |
|
$ |
0.10 |
|
|
$ |
0.93 |
|
|
$ |
2.78 |
|
|
$ |
(0.42 |
) |
Diluted |
|
$ |
0.10 |
|
|
$ |
0.93 |
|
|
$ |
2.76 |
|
|
$ |
(0.42 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Shares used in computing Non-GAAP net income (loss) per share: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Basic |
|
|
220,984 |
|
|
|
219,239 |
|
|
|
220,428 |
|
|
|
218,073 |
|
Diluted |
|
|
221,989 |
|
|
|
221,228 |
|
|
|
222,074 |
|
|
|
218,073 |
|
1 Included within the Milestone and contract revenues line item in the Condensed Consolidated Statements of Operations (in thousands) for the three and twelve months ended |
2 As included within the Cost of product revenues (including definite-lived intangible amortization) line item; the Research and development expenses line item; and the Selling, general and administrative expenses line item in the Condensed Consolidated Statements of Operations. |
3 As included within the Interest expense line item in the Condensed Consolidated Statements of Operations. |
4 As included within the Unrealized gain (loss) on long term investments line item in the Condensed Consolidated Statements of Operations. |
5 As included within the Cost of product revenues (including definite-lived intangible amortization) line item in the Condensed Consolidated Statements of Operations. Acquired product rights of licensed intellectual property for Iclusig is amortized utilizing a straight-line method over the estimated useful life of 12.5 years. |
6 As included within the Change in fair value of acquisition-related contingent consideration line item in the Condensed Consolidated Statements of Operations. |
7 As included within Selling, general and administrative expenses line item in the Condensed Consolidated Statements of Operations. |
8 Included within the (Benefit) provision for income taxes line item in the Condensed Consolidated Statements of Operations is portions of the provision for income taxes that are not associated with normal, recurring operations. For the three and twelve months ended |
9 Income tax effects of Non-GAAP pre-tax adjustments are calculated using the applicable statutory tax rate for the jurisdictions in which the charges are incurred, while taking into consideration any valuation allowances against related deferred tax assets. |
View source version on businesswire.com: https://www.businesswire.com/news/home/20220208005340/en/
Media
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Investors
+1 302 274 4773
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