Incyte Reports 2023 Third Quarter Financial Results and Provides Updates on Key Clinical Programs
– Total revenues of
– Jakafi® (ruxolitinib) net product revenues of
– Opzelura® (ruxolitinib) cream net product revenues of
– Phase 2 study evaluating povorcitinib in prurigo nodularis (PN) met its primary endpoint
Conference Call and Webcast Scheduled Today at
"Our double-digit revenue growth during the quarter was driven by sustained performance of Jakafi® (ruxolitinib) and an increasing contribution from Opzelura® (ruxolitinib) with continued strong patient demand and enhanced payer coverage," said
Key Company Updates
- In September,
Incyte was notified by theCenters for Medicare and Medicaid Services that ruxolitinib phosphate qualified for the Small Biotech Exception. - Beginning
January 1, 2024 , Opzelura will be listed as a Preferred Brand on the CVS Caremark and Aetna formularies impacting roughly 30 million commercial lives in theU.S.
Key Product Sales Performance
Jakafi:
Net product revenues for the quarter of
- Net product revenues grew 3% compared with the third quarter of 2022.
- Channel inventory at the end of the third quarter of 2023 decreased by approximately
$14 million versus the second quarter of 2023. Underlying demand in the third quarter of 2023 continued to grow both year-over-year and quarter-over-quarter.
Opzelura:
Net product revenues for the quarter of
- Net product revenues of
$92 million grew 141% compared with the third quarter of 2022, driven by growth in patient demand, refills and expansion in payer coverage as the launch in AD and vitiligo continues.
Pipeline Updates
Myeloproliferative Neoplasms (MPNs) and Graft-Versus-Host Disease (GVHD) – key highlights
- Combination trials of ruxolitinib twice daily (BID) with zilurgisertib (ALK2) and INCB57643 (BET) are ongoing and continue to enroll. Additional data from these studies are anticipated to be shared in the fourth quarter of 2023.
- The Phase 1 study evaluating INCA033989 (mCALR) is ongoing and enrolling patients.
- In October, we announced the development of a new program targeting the JAK2V617F mutation, which is present in 55-60% of myelofibrosis (MF) and essential thrombocythemia (ET) patients, and in 95% of polycythemia vera (PV) patients. INCB160058 is a small molecule inhibitor, targeting the JAK2V617F mutation and we expected to file the IND by year-end 2023.
|
|
Indication and status |
Ruxolitinib XR (QD) (JAK1/JAK2) |
|
Myelofibrosis, polycythemia vera and GVHD |
Ruxolitinib + zilurgisertib (JAK1/JAK2 + ALK2) |
|
Myelofibrosis: Phase 2 |
Ruxolitinib + INCB57643 (JAK1/JAK2 + |
|
Myelofibrosis: Phase 2 |
Ruxolitinib + CK08041 (JAK1/JAK2 + CB-Tregs) |
|
Myelofibrosis: Phase 1 (LIMBER-TREG108) |
Axatilimab (anti-CSF-1R)2 |
|
Chronic GVHD: Pivotal Phase 2 (third-line plus therapy) (AGAVE-201) |
Ruxolitinib + axatilimab2 (JAK1/JAK2 + anti-CSF-1R) |
|
Chronic GVHD: Phase 1/2 in preparation |
INCA033989 (mCALR) |
|
Myelofibrosis, essential thrombocythemia: Phase 1 |
1 Development collaboration with |
2 Clinical development of axatilimab in GVHD conducted in collaboration with Syndax Pharmaceuticals. |
Other Hematology/Oncology – key highlights
Oral small molecule PD-L1 program: Combination studies evaluating INCB99280 in combination with axitinib (VEGF) and in combination with ipilimumab (CTLA-4) are enrolling. Two Phase 2 monotherapy studies evaluating INCB99280 in patients with select solid tumors who are checkpoint inhibitor naive and in metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC, are enrolling.
|
|
Indication and status |
Pemigatinib (Pemazyre®) (FGFR1/2/3) |
|
Myeloid/lymphoid neoplasms (MLN): approved in the Cholangiocarcinoma (CCA): Phase 3 (FIGHT-302) Glioblastoma: Phase 2 (FIGHT-209) |
Tafasitamab (Monjuvi®/Minjuvi®)1 (CD19) |
|
Relapsed or refractory diffuse large B-cell lymphoma (DLBCL): Phase 3 (B-MIND) First-line DLBCL: Phase 3 (frontMIND) Relapsed or refractory follicular lymphoma (FL) and relapsed or refractory marginal zone lymphoma (MZL): Phase 3 (inMIND) |
Retifanlimab (Zynyz®)2 (PD-1) |
|
Merkel cell carcinoma (MCC): approved in the Squamous cell anal cancer (SCAC): Phase 3 (POD1UM-303) Non-small cell lung cancer (NSCLC): Phase 3 (POD1UM-304) MSI-high endometrial cancer: Phase 2 (POD1UM-101, POD1UM-204) |
INCB99280 (Oral PD-L1) |
|
Solid tumors (combination): Phase 1 Solid tumors (monotherapy): Phase 2 Cutaneous squamous cell carcinoma (cSCC): Phase 2 |
INCB99318 (Oral PD-L1) |
|
Solid tumors: Phase 1 |
1 Development of tafasitamab in collaboration with MorphoSys. |
2 Retifanlimab licensed from MacroGenics. |
3 Clinical trial collaboration and supply agreement with Mirati Therapeutics. |
Inflammation and Autoimmunity (IAI) – key highlights
Dermatology
Opzelura
- New results of a pooled analysis of long-term extension (LTE) data from the pivotal Phase 3 TRuE-V program assessing Opzelura cream 1.5% in patients 12 years of age and older with nonsegmental vitiligo who previously experienced limited or no response to treatment at Week 24 were presented at the
European Academy of Dermatology and Venereology (EADV)Congress 2023 as a late-breaking oral presentation . These results showed patients who initially experienced limited or no facial or total body repigmentation at six months achieved improved repigmentation after continued treatment with Opzelura for up to two years.
- Expanded results from the pivotal Phase 3 TRuE-AD3 study evaluating the safety and efficacy of ruxolitinib cream (Opzelura) in children (age ≥2 to <12 years) with atopic dermatitis (AD), the most common type of eczema, met its primary endpoint and was presented at EADV. Significantly more patients treated with ruxolitinib cream (0.75% and 1.5%) achieved Investigator’s Global Assessment Treatment Success than patients treated with vehicle control (non-medicated cream).
- Ruxolitinib cream in other indications: three Phase 2 studies in lichen planus, lichen sclerosus and mild to moderate hidradenitis suppurativa (HS) have completed enrollment. Two Phase 3 trials evaluating ruxolitinib cream in prurigo nodularis (PN) are ongoing.
Povorcitinib (INCB54707)
- Positive 52-week data from a Phase 2b clinical trial evaluating the safety and efficacy of povorcitinib, an investigational oral JAK1 inhibitor, in adult patients with extensive nonsegmental vitiligo were presented at EADV as a late-breaking oral presentation. Results showed that treatment with oral povorcitinib was associated with substantial total body and facial repigmentation across all treatment groups at Week 52 and further reinforces the efficacy profile and potential of povorcitinib as an oral treatment for patients with extensive nonsegmental vitiligo.
- The Phase 2, randomized, double-blind, placebo-controlled, dose ranging study evaluating the efficacy and safety of povorcitinib in participants with PN met its primary endpoint. A Phase 3 study in PN is being planned.
- Asthma and chronic spontaneous urticaria: Two Phase 2 trials in asthma and chronic spontaneous urticaria are enrolling.
|
|
Indication and status |
Ruxolitinib cream (Opzelura®)1 (JAK1/JAK2) |
|
AD: Phase 3 pediatric study (TRuE-AD3) Vitiligo: Phase 3 (TRuE-V1, TRuE-V2); approved in the Lichen planus: Phase 2 Lichen sclerosus: Phase 2 Hidradenitis suppurativa: Phase 2 Prurigo nodularis: Phase 3 (TRuE-PN1, TRuE-PN2) |
Ruxolitinib cream + UVB (JAK1/JAK2 + phototherapy) |
|
Vitiligo: Phase 2 |
Povorcitinib (JAK1) |
|
Hidradenitis suppurativa: Phase 2b; Phase 3 (STOP-HS1, STOP-HS2) Vitiligo: Phase 2; Phase 3 planned Prurigo nodularis: Phase 2 Asthma: Phase 2 Chronic spontaneous urticaria: Phase 2 |
INCA034460 (anti-IL-15Rβ) |
|
Vitiligo: Phase 1 initiated |
1 Novartis’ rights to ruxolitinib outside of |
Discovery and other early development – key highlights
INCA33890 (TGFβR2xPD-1): A Phase 1 study evaluating INCA33890 in patients with select advanced solid tumors has been initiated.
Modality |
|
Candidates |
Small molecules |
|
INCB123667 (CDK2) |
Monoclonal antibodies |
|
INCAGN2385 (LAG-3)1, INCAGN2390 (TIM-3)1 |
Bi-specific antibodies |
|
INCA32459 (LAG-3xPD-1)2, INCA33890 (TGFβR2xPD-1)2 |
1 Discovery collaboration with Agenus. |
2 Development in collaboration with Merus. |
Partnered – key highlights
Jakavi® (ruxolitinib)- In August, Novartis announced that Jakavi was approved in
|
|
Indication and status |
Ruxolitinib (Jakavi®)1 (JAK1/JAK2) |
|
Acute and chronic GVHD: approved in |
Baricitinib (Olumiant®)2 (JAK1/JAK2) |
|
AD: approved in Severe alopecia areata (AA): approved in the |
Capmatinib (Tabrecta®)3 (MET) |
|
NSCLC (with MET exon 14 skipping mutations): approved in the |
1 Ruxolitinib (Jakavi®) licensed to Novartis ex- |
2 Baricitinib (Olumiant®) 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 Capmatinib (Tabrecta®) licensed to Novartis. |
2023 Third Quarter Financial Results
The financial measures presented in this press release for the three and nine months 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.
As changes in exchange rates are an important factor in understanding period-to-period comparisons, Management believes the presentation of certain revenue results on a constant currency basis in addition to reported results helps improve investors’ ability to understand its operating results and evaluate its performance in comparison to prior periods. Constant currency information compares results between periods as if exchange rates had remained constant period over period. The Company calculates constant currency by calculating current year results using prior year foreign currency exchange rates and generally refers to such amounts calculated on a constant currency basis as excluding the impact of foreign exchange or being on a constant currency basis. These results should be considered in addition to, not as a substitute for, results reported in accordance with GAAP. Results on a constant currency basis, as the Company presents them, may not be comparable to similarly titled measures used by other companies and are not measures of performance presented in accordance with GAAP.
Financial Highlights
Financial Highlights |
|||||||||||
(unaudited, in thousands, except per share amounts) |
|||||||||||
|
Three Months Ended |
|
Nine Months Ended |
||||||||
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
Total GAAP revenues |
$ |
919,025 |
|
$ |
823,303 |
|
$ |
2,682,308 |
|
$ |
2,467,935 |
|
|
|
|
|
|
|
|
||||
Total GAAP operating income |
|
214,705 |
|
|
138,376 |
|
|
433,255 |
|
|
509,347 |
Total Non-GAAP operating income |
|
273,294 |
|
|
167,271 |
|
|
625,081 |
|
|
649,042 |
|
|
|
|
|
|
|
|
||||
GAAP net income |
|
171,269 |
|
|
112,775 |
|
|
396,520 |
|
|
312,199 |
Non-GAAP net income |
|
248,719 |
|
|
133,795 |
|
|
556,325 |
|
|
483,015 |
|
|
|
|
|
|
|
|
||||
GAAP basic EPS |
$ |
0.76 |
|
$ |
0.51 |
|
$ |
1.77 |
|
$ |
1.41 |
Non-GAAP basic EPS |
$ |
1.11 |
|
$ |
0.60 |
|
$ |
2.49 |
|
$ |
2.18 |
GAAP diluted EPS |
$ |
0.76 |
|
$ |
0.50 |
|
$ |
1.76 |
|
$ |
1.40 |
Non-GAAP diluted EPS |
$ |
1.10 |
|
$ |
0.60 |
|
$ |
2.46 |
|
$ |
2.16 |
Revenue Details
Revenue Details |
|||||||||||||||||||
(unaudited, in thousands) |
|||||||||||||||||||
|
Three Months Ended |
|
% |
|
% |
|
Nine Months Ended |
|
% |
|
% |
||||||||
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
|||||||
Net product revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Jakafi |
$ |
636,252 |
|
$ |
619,595 |
|
3% |
|
3% |
|
$ |
1,898,605 |
|
$ |
1,761,732 |
|
8% |
|
8% |
Opzelura |
|
91,836 |
|
|
38,140 |
|
141% |
|
140% |
|
|
228,621 |
|
|
67,454 |
|
239% |
|
239% |
Iclusig |
|
27,721 |
|
|
25,929 |
|
7% |
|
(1%) |
|
|
84,493 |
|
|
78,222 |
|
8% |
|
7% |
Pemazyre |
|
18,942 |
|
|
23,414 |
|
(19%) |
|
(20%) |
|
|
62,989 |
|
|
60,429 |
|
4% |
|
5% |
Minjuvi |
|
8,348 |
|
|
5,932 |
|
41% |
|
43% |
|
|
28,063 |
|
|
14,845 |
|
89% |
|
90% |
Zynyz |
|
98 |
|
|
— |
|
NM |
|
NM |
|
|
668 |
|
|
— |
|
NM |
|
NM |
Total net product revenues |
|
783,197 |
|
|
713,010 |
|
10% |
|
10% |
|
|
2,303,439 |
|
|
1,982,682 |
|
16% |
|
16% |
Royalty revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Jakavi |
|
96,551 |
|
|
85,808 |
|
13% |
|
11% |
|
|
263,691 |
|
|
240,386 |
|
10% |
|
12% |
Olumiant |
|
29,615 |
|
|
20,371 |
|
45% |
|
47% |
|
|
95,779 |
|
|
98,689 |
|
(3%) |
|
2% |
Tabrecta |
|
4,139 |
|
|
4,114 |
|
1% |
|
NA |
|
|
13,115 |
|
|
11,178 |
|
17% |
|
NA |
Pemazyre |
|
523 |
|
|
— |
|
NM |
|
NM |
|
|
1,284 |
|
|
— |
|
NM |
|
NM |
Total royalty revenues |
|
130,828 |
|
|
110,293 |
|
19% |
|
|
|
|
373,869 |
|
|
350,253 |
|
7% |
|
|
Total net product and royalty revenues |
|
914,025 |
|
|
823,303 |
|
11% |
|
|
|
|
2,677,308 |
|
|
2,332,935 |
|
15% |
|
|
Milestone and contract revenues |
|
5,000 |
|
|
— |
|
NM |
|
NM |
|
|
5,000 |
|
|
135,000 |
|
(96%) |
|
(96%) |
Total GAAP revenues |
$ |
919,025 |
|
$ |
823,303 |
|
12% |
|
|
|
$ |
2,682,308 |
|
$ |
2,467,935 |
|
9% |
|
|
NM = not meaningful |
NA = not available |
1.Percentage change in constant currency is calculated using 2022 foreign exchange rates to recalculate 2023 results. |
Product and Royalty Revenues Product revenues and product and royalty revenues for the quarter ended
Operating Expenses
Operating Expense Summary |
|||||||||||||||
(unaudited, in thousands) |
|||||||||||||||
|
Three Months Ended |
|
% |
|
Nine Months Ended |
|
% |
||||||||
|
|
2023 |
|
|
2022 |
|
2023 |
|
|
2022 |
|||||
GAAP cost of product revenues |
$ |
60,091 |
|
$ |
54,584 |
|
10% |
|
$ |
185,239 |
|
$ |
147,834 |
|
25% |
Non-GAAP cost of product revenues1 |
|
53,914 |
|
|
48,521 |
|
11% |
|
|
166,733 |
|
|
129,715 |
|
29% |
|
|
|
|
|
|
|
|
|
|
|
|
||||
GAAP research and development |
|
375,709 |
|
|
384,007 |
|
(2%) |
|
|
1,183,100 |
|
|
1,084,576 |
|
9% |
Non-GAAP research and development2 |
|
348,868 |
|
|
358,268 |
|
(3%) |
|
|
1,092,409 |
|
|
1,004,372 |
|
9% |
|
|
|
|
|
|
|
|
|
|
|
|
||||
GAAP selling, general and administrative |
|
267,893 |
|
|
266,460 |
|
1% |
|
|
867,428 |
|
|
729,321 |
|
19% |
Non-GAAP selling, general and administrative3 |
|
241,896 |
|
|
247,474 |
|
(2%) |
|
|
798,943 |
|
|
675,751 |
|
18% |
|
|
|
|
|
|
|
|
|
|
|
|
||||
GAAP (gain) loss on change in fair value of acquisition-related contingent consideration |
|
(426) |
|
|
(21,893) |
|
(98%) |
|
|
14,144 |
|
|
(12,198) |
|
(216%) |
Non-GAAP (gain) loss on change in fair value of acquisition-related contingent consideration4 |
|
— |
|
|
— |
|
—% |
|
|
— |
|
|
— |
|
—% |
|
|
|
|
|
|
|
|
|
|
|
|
||||
GAAP loss and (profit) sharing under collaboration agreements5 |
|
1,053 |
|
|
1,769 |
|
(40%) |
|
|
(858) |
|
|
9,055 |
|
(109%) |
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 asset impairments. |
4 Non-GAAP (gain) loss on change in fair value of acquisition-related contingent consideration is null. |
5 Growth rate in GAAP loss and (profit) sharing under collaboration agreements represents a decrease in loss position for the three and nine months ended |
Cost of product revenues GAAP and Non-GAAP cost of product revenues for the quarter ended
Research and development expenses GAAP and Non-GAAP research and development expense for the quarter ended
Selling, general and administrative expenses GAAP and Non-GAAP selling, general and administrative expenses for the quarter ended
Other Financial Information
Operating income GAAP and Non-GAAP operating income for the three months ended
Cash, cash equivalents and marketable securities position As of
2023 Financial Guidance
|
Current |
Previous |
Jakafi net product revenues |
|
|
Other Hematology/Oncology net product revenues(1) |
Unchanged |
|
GAAP Cost of product revenues |
Unchanged |
7 – 8% of net product revenues |
Non-GAAP Cost of product revenues(2) |
Unchanged |
6 – 7% of net product revenues |
|
Unchanged |
|
|
Unchanged |
|
GAAP Selling, general and administrative expenses |
Unchanged |
|
Non-GAAP Selling, general and administrative expenses(3) |
Unchanged |
|
1Pemazyre in the |
2Adjusted 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® (ruxolitinib) is a JAK1/JAK2 inhibitor approved by the
Jakafi is a registered trademark of
About Opzelura® (ruxolitinib) Cream 1.5%
Opzelura, a novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib, approved by the
In
Opzelura and the Opzelura logo are registered trademarks of
About Monjuvi®/Minjuvi® (tafasitamab)
Tafasitamab is a humanized Fc-modified CD19 targeting immunotherapy. 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. Its safety and efficacy for these investigational uses have not been established in pivotal 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
Pemazyre is also the first targeted treatment approved for use 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.
About Zynyz™ (retifanlimab-dlwr)
Zynyz (retifanlimab-dlwr), is an intravenous PD-1 inhibitor indicated in the
Zynyz is marketed by
Zynyz is a trademark of
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 potential for continued performance and growth; Incyte’s financial guidance for 2023, including its expectations regarding sales of Jakafi; expectations with respect to demand for and payer coverage of Opzelura; expectations regarding the potential and progress of programs in our pipeline, including mCALR and JAK2V617F; expectations regarding ongoing clinical trials and clinical trials to be initiated, including combination trials of ruxolitinib twice daily (BID) with zilurgisertib (ALK2) and INCB57643 (BET), a phase 3 trial of povorcitinib in prurigo nodularis and phase 2 trials of povorcitinib in asthma and chronic spontaneous urticaria, a phase 1/2 trial of ruxolitinib and axatilimab in chronic GVHD, various trials in our oral small molecule PD-L1 program, various phase 2 and 3 trials for ruxolitinib cream; our expectations regarding regulatory filings, including the planned submission of an IND for INCB100658 by year-end 2023; and our expectations regarding 2023 newsflow items.
These forward-looking statements are based on Incyte’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; determinations made by the FDA, EMA, and other regulatory agencies; Incyte’s dependence on its relationships with and changes in the plans of its collaboration partners; the efficacy or safety of Incyte’s products and the products of Incyte’s collaboration partners; the acceptance of Incyte’s products and the products of Incyte’s collaboration partners in the marketplace; market competition; unexpected variations in the demand for Incyte’s products and the products of Incyte’s collaboration partners; the effects of announced or unexpected price regulation or limitations on reimbursement or coverage for Incyte’s products and the products of Incyte’s collaboration partners; sales, marketing, manufacturing and distribution requirements, including Incyte’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; variations in foreign currency exchange rates; and other risks detailed in Incyte’s reports filed with the
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|||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
|||||||||||
(unaudited, in thousands, except per share amounts) |
|||||||||||
|
Three Months Ended |
|
Nine Months Ended |
||||||||
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
|
|
|
|
|
|
|
||||
|
GAAP |
|
GAAP |
||||||||
Revenues: |
|
|
|
|
|
|
|
||||
Product revenues, net |
$ |
783,197 |
|
$ |
713,010 |
|
$ |
2,303,439 |
|
$ |
1,982,682 |
Product royalty revenues |
|
130,828 |
|
|
110,293 |
|
|
373,869 |
|
|
350,253 |
Milestone and contract revenues |
|
5,000 |
|
|
— |
|
|
5,000 |
|
|
135,000 |
Total revenues |
|
919,025 |
|
|
823,303 |
|
|
2,682,308 |
|
|
2,467,935 |
|
|
|
|
|
|
|
|
||||
Costs and expenses: |
|
|
|
|
|
|
|
||||
Cost of product revenues (including definite-lived intangible amortization) |
|
60,091 |
|
|
54,584 |
|
|
185,239 |
|
|
147,834 |
Research and development |
|
375,709 |
|
|
384,007 |
|
|
1,183,100 |
|
|
1,084,576 |
Selling, general and administrative |
|
267,893 |
|
|
266,460 |
|
|
867,428 |
|
|
729,321 |
(Gain) loss on change in fair value of acquisition-related contingent consideration |
|
(426) |
|
|
(21,893) |
|
|
14,144 |
|
|
(12,198) |
Loss and (profit) sharing under collaboration agreements |
|
1,053 |
|
|
1,769 |
|
|
(858) |
|
|
9,055 |
Total costs and expenses |
|
704,320 |
|
|
684,927 |
|
|
2,249,053 |
|
|
1,958,588 |
|
|
|
|
|
|
|
|
||||
Income from operations |
|
214,705 |
|
|
138,376 |
|
|
433,255 |
|
|
509,347 |
Interest income and other, net |
|
46,371 |
|
|
11,513 |
|
|
121,912 |
|
|
13,295 |
Interest expense |
|
(623) |
|
|
(641) |
|
|
(1,747) |
|
|
(1,999) |
Unrealized (loss) gain on long term investments |
|
(26,654) |
|
|
(660) |
|
|
9,839 |
|
|
(72,142) |
Income before provision for income taxes |
|
233,799 |
|
|
148,588 |
|
|
563,259 |
|
|
448,501 |
Provision for income taxes |
|
62,530 |
|
|
35,813 |
|
|
166,739 |
|
|
136,302 |
Net income |
$ |
171,269 |
|
$ |
112,775 |
|
$ |
396,520 |
|
$ |
312,199 |
|
|
|
|
|
|
|
|
||||
Net income per share: |
|
|
|
|
|
|
|
||||
Basic |
$ |
0.76 |
|
$ |
0.51 |
|
$ |
1.77 |
|
$ |
1.41 |
Diluted |
$ |
0.76 |
|
$ |
0.50 |
|
$ |
1.76 |
|
$ |
1.40 |
|
|
|
|
|
|
|
|
||||
Shares used in computing net income per share: |
|
|
|
|
|
|
|
||||
Basic |
|
224,078 |
|
|
222,415 |
|
|
223,428 |
|
|
221,801 |
Diluted |
|
226,167 |
|
|
224,175 |
|
|
225,756 |
|
|
223,626 |
|
|||||
CONDENSED CONSOLIDATED BALANCE SHEETS |
|||||
(unaudited, in thousands) |
|||||
|
|
|
|
||
ASSETS |
|
|
|
||
Cash, cash equivalents and marketable securities |
$ |
3,516,453 |
|
$ |
3,238,965 |
Accounts receivable |
|
657,263 |
|
|
644,879 |
Property and equipment, net |
|
733,046 |
|
|
739,310 |
Finance lease right-of-use assets, net |
|
24,880 |
|
|
26,298 |
Inventory |
|
199,286 |
|
|
120,959 |
Prepaid expenses and other assets |
|
254,421 |
|
|
194,144 |
Long term investments |
|
153,663 |
|
|
133,676 |
Other intangible assets, net |
|
129,249 |
|
|
129,219 |
|
|
155,593 |
|
|
155,593 |
Deferred income tax asset |
|
564,385 |
|
|
457,941 |
Total assets |
$ |
6,388,239 |
|
$ |
5,840,984 |
|
|
|
|
||
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
||
Accounts payable, accrued expenses and other liabilities |
$ |
1,217,869 |
|
$ |
1,216,603 |
Finance lease liabilities |
|
31,923 |
|
|
33,262 |
Acquisition-related contingent consideration |
|
207,000 |
|
|
221,000 |
Stockholders’ equity |
|
4,931,447 |
|
|
4,370,119 |
Total liabilities and stockholders’ equity |
$ |
6,388,239 |
|
$ |
5,840,984 |
|
|||||||||||
RECONCILIATION OF GAAP NET (LOSS) INCOME TO SELECTED NON-GAAP ADJUSTED INFORMATION |
|||||||||||
(unaudited, in thousands, except per share amounts) |
|||||||||||
|
Three Months Ended |
|
Nine Months Ended |
||||||||
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
GAAP Net Income |
$ |
171,269 |
|
$ |
112,775 |
|
$ |
396,520 |
|
$ |
312,199 |
Adjustments1: |
|
|
|
|
|
|
|
||||
Non-cash stock compensation from equity awards (R&D)2 |
|
26,841 |
|
|
25,739 |
|
|
90,691 |
|
|
80,204 |
Non-cash stock compensation from equity awards (SG&A)2 |
|
20,366 |
|
|
18,986 |
|
|
62,854 |
|
|
53,570 |
Non-cash stock compensation from equity awards (COGS)2 |
|
793 |
|
|
679 |
|
|
2,354 |
|
|
1,967 |
Non-cash interest3 |
|
108 |
|
|
72 |
|
|
355 |
|
|
288 |
Changes in fair value of equity investments4 |
|
26,654 |
|
|
660 |
|
|
(9,839) |
|
|
72,142 |
Amortization of acquired product rights5 |
|
5,384 |
|
|
5,384 |
|
|
16,152 |
|
|
16,152 |
(Gain) loss on change in fair value of contingent consideration6 |
|
(426) |
|
|
(21,893) |
|
|
14,144 |
|
|
(12,198) |
Asset impairment7 |
|
5,631 |
|
|
— |
|
|
5,631 |
|
|
— |
Tax effect of Non-GAAP pre-tax adjustments8 |
|
(7,901) |
|
|
(8,607) |
|
|
(22,537) |
|
|
(41,309) |
Non-GAAP Net Income |
$ |
248,719 |
|
$ |
133,795 |
|
$ |
556,325 |
|
$ |
483,015 |
|
|
|
|
|
|
|
|
||||
Non-GAAP net income per share: |
|
|
|
|
|
|
|
||||
Basic |
$ |
1.11 |
|
$ |
0.60 |
|
$ |
2.49 |
|
$ |
2.18 |
Diluted |
$ |
1.10 |
|
$ |
0.60 |
|
$ |
2.46 |
|
$ |
2.16 |
|
|
|
|
|
|
|
|
||||
Shares used in computing Non-GAAP net income per share: |
|
|
|
|
|
|
|
||||
Basic |
|
224,078 |
|
|
222,415 |
|
|
223,428 |
|
|
221,801 |
Diluted |
|
226,167 |
|
|
224,175 |
|
|
225,756 |
|
|
223,626 |
1 Included within the Milestone and contract revenues line item in the Condensed Consolidated Statements of Operations (in thousands) for the three and nine 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 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 (Gain) loss on change in fair value of acquisition-related contingent consideration line item in the Condensed Consolidated Statements of Operations. |
7 As included within the Selling, general and administrative expenses line item in the Condensed Consolidated Statements of Operations. |
8 Income tax effects of Non-GAAP pre-tax adjustments are calculated using an estimated annual effective tax rate, taking into consideration any permanent items and valuation allowances against related deferred tax assets. |
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