Skip to content
AnalystLens

INCY · Incyte

50 filings

10-Q

INCY 10-Q Quarterly Reports

Incyte - 50 quarterly reports

Filing record · 2016–202610-K1510-Q348-K107

INCY filed 15 annual reports (10-K), 34 quarterly reports (10-Q) and 107 current reports (8-K) between 2016 and 2026.

  1. Material agreement8-K · Dec ’16Dec ’16
  2. FY2018 annual report10-K · Feb ’19Feb ’19
  3. Leadership change8-K · Jan ’22Jan ’22
  4. Leadership change8-K · Dec ’25Dec ’25
  1. 2026-Q3

    Incyte Quarterly Report for Q3 Ended Sep 30, 2026

    Incyte Corporation's Form 10-Q for the quarter ended September 30, 2026 shows a net loss of $784.8 million, or $3.86 per share, for the three months ended September 30, 2026, compared with net income of $424.2 million, or $2.11 diluted per share, a year earlier. The loss was driven primarily by a $1.23 billion in-process R&D charge (recorded as R&D expense) for the acquisition of Vega Therapeutics, whose lead asset is latarcibart for von Willebrand disease. Total revenues were $1.557 billion for the quarter, up from $1.366 billion, led by JAKAFI net sales of $826.5 million and OPZELURA net sales of $254.9 million. For the nine months, net income was $104.1 million, down from $987.4 million, with total revenues of $4.504 billion. The nine-month results include a one-time, non-cash $246.0 million benefit to OPZELURA net sales from the resolution of Medicaid rebate litigation with CMS. The filing also reports a non-deductible $1.23 billion Vega charge that pushed the nine-month effective tax rate to 74.4%. Operating cash flow fell to $201.7 million for the nine months from $870.2 million, which management attributes primarily to the Vega cash consideration. At September 30, 2026, cash, cash equivalents and marketable securities totaled $3.9 billion, and the company had no outstanding borrowings under its $500.0 million revolving credit facility. The filing also notes a change in inventory costing method to FIFO effective July 1, 2026, which the company states did not have a material effect on inventory or cost of sales for any period presented. Patent litigation against generic JAKAFI and OPZELURA filers remains pending, with JAKAFI composition-of-matter patents expiring in mid-2028, and the company states that JAKAFI revenues are expected to decline after patent exclusivity expires in 2028.

    Oct 29, 2026
  2. 2026-Q2

    Incyte Quarterly Report for Q2 Ended Jun 30, 2026

    Incyte Corporation's 10-Q for the quarter ended June 30, 2026 reports total revenues of $1.67 billion for the second quarter, up from $1.22 billion a year earlier, and net income of $585.6 million, or $2.81 per diluted share, compared with $405.0 million, or $2.04 per diluted share, in the prior-year quarter. Net sales were $1.49 billion, including a one-time, non-cash $246.0 million benefit from the reversal of previously established accruals after Incyte reached an agreement with CMS resolving litigation over the Medicaid rebate treatment of OPZELURA. JAKAFI net sales were $816.7 million for the quarter, and OPZELURA net sales were $449.7 million, which includes that $246.0 million benefit. Cash, cash equivalents and marketable securities totaled $4.5 billion at June 30, 2026, and net cash provided by operating activities was $877.0 million for the six months. Research and development expense was $516.9 million for the quarter. The company also notes a subsequent event: it completed the acquisition of Vega Therapeutics on July 6, 2026 for $1.25 billion in cash, with up to $750.0 million in additional sales-based payments, and expects to expense the upfront consideration as in-process research and development in the third quarter of 2026. The filing also describes pipeline and regulatory activity, including the May 2026 FDA approval of JAKAFI XR, the planned povorcitinib filings, and Phase 3 programs for INCA033989 and tafasitamab. JAKAFI's composition-of-matter patents are noted as expiring in 2028, and the filing states that generic challengers have filed ANDAs and Paragraph IV certifications against JAKAFI and OPZELURA, with several of the JAKAFI actions settled and others still pending.

    Jul 28, 2026
  3. 2026-Q1

    Incyte Quarterly Report for Q1 Ended Mar 31, 2026

    Incyte Corporation's first-quarter 2026 Form 10-Q reports total revenues of $1,272.7 million for the three months ended March 31, 2026, up from $1,052.9 million a year earlier. Net sales were $1,104.5 million, led by JAKAFI at $757.8 million, and product royalty revenues were $151.2 million. Net income was $303.3 million, or $1.47 per diluted share, compared with $158.2 million, or $0.80 per diluted share, in the prior-year quarter. The effective tax rate fell to 11.7% from 32.4%, reflecting recognition of previously unrecognized tax benefits, valuation allowance reversals and favorable effects of the One Big Beautiful Bill Act. The balance sheet strengthened, with cash and cash equivalents of $3.46 billion and marketable securities of $554.7 million at March 31, 2026, and no outstanding borrowings under the $500.0 million revolving credit facility. Net cash provided by operating activities was $369.4 million. Research and development expense rose to $515.9 million and selling, general and administrative expense to $328.1 million. A $23.2 million asset impairment and disposal charge related to the sale of downtown Wilmington, Delaware properties was also recorded. The filing highlights ongoing legal and commercial risks. The company has accrued approximately $245.9 million related to a dispute with CMS over whether OPZELURA should be treated as a line extension of JAKAFI for Medicaid rebate purposes. Generic challenges to JAKAFI and OPZELURA patents remain pending, and the filing states that JAKAFI product sales are expected to decline after patent exclusivity expires in 2028. The filing also discloses the appointment of Suketu Upadhyay as Executive Vice President and Chief Financial Officer, effective May 4, 2026.

    Apr 28, 2026
  4. 2025-Q3

    Incyte Quarterly Report for Q3 Ended Sep 30, 2025

    Incyte Corporation reported third-quarter 2025 total revenues of $1.37 billion, up from $1.14 billion in the third quarter of 2024, and net income of $424.2 million (basic EPS $2.17, diluted EPS $2.11), compared with net income of $106.5 million ($0.55 basic, $0.54 diluted) a year earlier. Product revenues, net were $1.15 billion, led by JAKAFI at $791.1 million and OPZELURA at $188.0 million. NIKTIMVO generated $45.8 million in its first full quarters of U.S. launch activity, and ZYNYZ revenue rose after its May 2025 approval in squamous cell anal carcinoma. For the nine months, net income was $987.4 million, compared with a net loss of $168.6 million in 2024. The nine-month results include a $242.2 million difference recorded in contract dispute settlement from the May 2025 settlement agreement with Novartis, which resolved litigation over the duration of JAKAFI royalty payments. On the balance sheet, cash and cash equivalents were $2.46 billion and available cash, cash equivalents and marketable securities totaled $2.9 billion at September 30, 2025. Net cash provided by operating activities was $870.2 million for the nine months, compared with net cash used of $45.9 million a year earlier. No borrowings were outstanding under the $500.0 million revolving credit facility, which matures in June 2027. Stockholders' equity was $4.65 billion. Management stated that cash flow from operations and existing resources are expected to be adequate for capital needs for the foreseeable future. The filing also flags several items that bear on future results. Incyte accrued approximately $188.9 million relating to incremental rebates if OPZELURA were treated as a line extension of JAKAFI under the Medicaid rebate program, and the filing states this affected OPZELURA gross-to-net deductions by approximately 6.8% in the quarter. JAKAFI faces ANDA and 505(b)(2) challenges from generic filers, with the relevant patents expiring in June 2028 and December 2028 including pediatric extension, and an October 2025 settlement with Hikma. In October 2025, Incyte amended its agreement with Eli Lilly to allow Lilly to commercialize baricitinib for Type 1 diabetes, in exchange for a $100.0 million upfront payment and restructured royalties. The company also discontinued development of INCB57643 and decided not to pursue further development of povorcitinib in chronic spontaneous urticaria.

    Oct 28, 2025
  5. 2025-Q2

    Incyte Quarterly Report for Q2 Ended Jun 30, 2025

    Incyte reported total revenues of $1.22 billion for the three months ended June 30, 2025, up from $1.04 billion a year earlier. Net income was $405.0 million, or $2.04 per diluted share, compared with a net loss of $444.6 million in the prior-year quarter. That loss included $679.4 million of acquired in-process research and development expense tied to the Escient acquisition. Product revenues were $1.06 billion, led by JAKAFI at $763.8 million, OPZELURA at $164.5 million and NIKTIMVO at $36.2 million. Quarterly results also include a $242.3 million credit recorded as contract dispute settlement after the May 2025 settlement with Novartis over the duration of JAKAFI royalty payments. Under that settlement, Incyte paid Novartis $280.0 million and agreed to reduce by 50% the royalty rate on future U.S. JAKAFI net sales beginning January 1, 2025. For the six months ended June 30, 2025, total revenues were $2.27 billion and net income was $563.2 million, or $2.84 per diluted share. Operating cash flow was $310.8 million, compared with a use of $356.8 million in the prior-year period. Research and development expense was $494.9 million for the quarter, versus $1,138.4 million a year earlier, and selling, general and administrative expense was $331.0 million, versus $306.0 million. At June 30, 2025, cash, cash equivalents and marketable securities totaled $2.4 billion, and the $500.0 million revolving credit facility had no outstanding borrowings. Key risks remain concentrated in JAKAFI. Apotex, Hikma, Sun and Granules have filed paragraph IV challenges seeking approval of generic versions, and Incyte has sued them on certain patents. Incyte has accrued $165.2 million related to its lawsuit against CMS over whether OPZELURA should be treated as a line extension of JAKAFI for Medicaid rebates, which the filing says affected the quarter's gross-to-net deductions by 6.6%. In July 2025, Incyte entered into a settlement and license agreement with Sun Pharmaceuticals resolving patent litigation over Leqselvi (deuruxolitinib). The company is still evaluating the effects of the One Big Beautiful Bill Act, enacted July 4, 2025. The effective tax rate was 27.4% for the quarter and 28.9% for the six months.

    Jul 29, 2025
  6. 2025-Q1

    Incyte Quarterly Report for Q1 Ended Mar 31, 2025

    Incyte Corporation's first-quarter 2025 Form 10-Q reports total revenues of $1.05 billion, up from $880.9 million in the prior-year quarter, driven primarily by JAKAFI product revenues of $709.4 million (versus $571.8 million). Net product revenues were $922.3 million and product royalty revenues were $130.6 million. Net income was $158.2 million, or $0.80 per diluted share, compared with $169.5 million, or $0.75 per diluted share, in the first quarter of 2024. The prior-year quarter benefited from a $99.9 million gain on equity investments, while the current quarter recorded a $1.3 million loss on equity investments. Interest income fell to $22.9 million from $46.8 million as cash and marketable securities balances declined. Operating income rose to $205.2 million from $91.9 million. Cash provided by operating activities was $266.1 million. At March 31, 2025, the company had $2.4 billion of cash, cash equivalents and marketable securities and no borrowings under its $500.0 million revolving credit facility. Total stockholders' equity was $3.67 billion. Investors should note several risks disclosed in the filing. The company has accrued approximately $145.4 million relating to incremental Medicaid rebates tied to its CMS line-extension dispute over OPZELURA. A contract dispute with Novartis over JAKAFI royalties is pending, with a trial scheduled for May 2025. Generic challenges to JAKAFI and OPZELURA are also pending, and the filing reports that the Federal Circuit vacated the preliminary injunction against Sun's deuterated ruxolitinib product (Leqselvi) on April 9, 2025.

    Apr 29, 2025
  7. 2024-Q3

    Incyte Quarterly Report for Q3 Ended Sep 30, 2024

    Incyte Corporation's Form 10-Q for the quarter ended September 30, 2024 shows a sharp swing to a nine-month net loss of $168.6 million, versus net income of $396.5 million in the prior-year period, driven mainly by a $679.4 million in-process R&D charge tied to the May 30, 2024 acquisition of Escient Pharmaceuticals for $782.5 million in cash. Third-quarter results were profitable: total revenues were $1.14 billion, up from $919.0 million, and net income was $106.5 million ($0.54 diluted EPS), compared with $171.3 million a year earlier. Product revenues rose to $963.0 million, led by JAKAFI at $741.2 million and OPZELURA at $139.3 million, and the MINJUVI/MONJUVI revenue increase reflected the February 2024 acquisition of global tafasitamab rights. Cash and capital position declined materially during the period. Cash and cash equivalents fell to $1.30 billion from $3.21 billion at year-end 2023, largely because of the roughly $2.0 billion share repurchase completed in June 2024 through a modified Dutch auction tender offer at $60.00 per share and a related purchase from the Baker Entities. Net cash used in operating activities was $45.9 million for the nine months, compared with $348.8 million provided a year earlier. Total stockholders' equity decreased to $3.17 billion from $5.19 billion, and the company had no borrowings under its $500.0 million revolving credit facility. The filing also highlights several contingent items. Accrued royalties of $469.5 million owed to Novartis are tied to the outcome of a contract dispute over U.S. JAKAFI royalties, and the company has accrued approximately $106.9 million relating to possible Medicaid rebates if OPZELURA were treated as a line extension of JAKAFI, a matter it is contesting in litigation against CMS. Research and development expense for the nine months rose to $2.14 billion, including the Escient charge and a $100.0 million MacroGenics milestone payment.

    Oct 29, 2024
  8. 2024-Q2

    Incyte Quarterly Report for Q2 Ended Jun 30, 2024

    Incyte Corporation's Form 10-Q for the quarter ended June 30, 2024 reports a net loss of $444.6 million, or $2.04 per share, for the three months ended June 30, 2024, compared with net income of $203.5 million, or $0.91 per basic share, in the prior-year quarter. For the six months, the company reported a net loss of $275.1 million, or $1.24 per share. The swing was driven primarily by a $679.4 million charge for acquired in-process research and development from the May 30, 2024 acquisition of Escient Pharmaceuticals, Inc., which was expensed as research and development. Total revenues rose to $1,043.8 million in the quarter from $954.6 million, led by product revenues of $906.6 million, with JAKAFI revenues of $706.0 million and OPZELURA revenues of $121.7 million. Balance sheet and capital allocation changed significantly during the period. Cash and cash equivalents declined to $987.3 million at June 30, 2024 from $3.21 billion at December 31, 2023, reflecting a $2.0 billion share repurchase completed in June 2024 (33,325,849 shares at $60.00 per share, including 5,459,183 shares bought from the Baker Entities). Total stockholders' equity fell to $2.997 billion from $5.190 billion. Net cash used in operating activities was $356.8 million for the six months, versus $200.9 million provided in the prior-year period, which the filing attributes primarily to the Escient acquisition and working capital changes. The company also held $462.2 million in marketable securities and $69.9 million in short-term equity investments, and its $500.0 million revolving credit facility was undrawn and was extended to June 2027. The filing also highlights ongoing risks: a $433.2 million accrued royalty liability tied to a contract dispute with Novartis over U.S. JAKAFI royalties, a $91.1 million accrual related to a lawsuit against CMS over the OPZELURA Medicaid line-extension designation, and the company's reliance on JAKAFI for a significant share of revenue. Management also disclosed a strategic pipeline review in July 2024 that will discontinue several earlier-stage programs.

    Jul 30, 2024
  9. 2024-Q1

    Incyte Quarterly Report for Q1 Ended Mar 31, 2024

    Incyte Corporation's 10-Q for the quarter ended March 31, 2024 reports total revenues of $880.9 million, up from $808.7 million in the prior-year quarter. Product revenues, net were $729.9 million, led by JAKAFI at $571.8 million, while OPZELURA grew to $85.7 million from $56.6 million. Product royalty revenues were $126.0 million and milestone and contract revenues were $25.0 million, the latter from an upfront payment tied to the povorcitinib license with China Medical Systems Holdings Limited. Net income was $169.5 million, or $0.75 per diluted share, versus $21.7 million, or $0.10 per diluted share, a year earlier. Income from operations was $91.9 million compared with $24.8 million, and an unrealized gain on long term investments of $99.9 million, driven mainly by Merus and MorphoSys, contributed to the result. The company had cash, cash equivalents and marketable securities of $3.9 billion at March 31, 2024, and no outstanding borrowings under its $500.0 million revolving credit facility. Net cash provided by operating activities was $218.8 million. Research and development expense was $429.3 million and selling, general and administrative expense was $300.3 million. Total stockholders' equity rose to $5.39 billion from $5.19 billion at December 31, 2023. Investors should note the filing's disclosures on pending items: the company agreed in April 2024 to acquire Escient Pharmaceuticals for $750.0 million plus Escient's net cash, subject to Hart-Scott-Rodino clearance. The company also disclosed a $73.7 million accrual tied to its lawsuit against CMS over whether OPZELURA should be treated as a line extension of JAKAFI, and $398.6 million of accrued royalties payable to Novartis that depend on the outcome of a contract dispute.

    Apr 30, 2024
  10. 2023-Q3

    Incyte Quarterly Report for Q3 Ended Sep 30, 2023

    Incyte Corporation's Form 10-Q for the quarter ended September 30, 2023 reports total revenues of $919.0 million for the three months ended September 30, 2023, up from $823.3 million in the prior-year period, and net income of $171.3 million, or $0.76 per diluted share, versus $112.8 million, or $0.50 per diluted share, a year earlier. For the nine months, total revenues were $2.68 billion and net income was $396.5 million, or $1.76 per diluted share. Product revenues, net, were $783.2 million in the quarter, led by JAKAFI at $636.3 million and OPZELURA at $91.8 million, with OPZELURA revenues rising from $38.1 million a year earlier. Product royalty revenues were $130.8 million for the quarter. Research and development expense was $375.7 million for the quarter and selling, general and administrative expense was $267.9 million, the latter reflecting the establishment of the dermatology commercial organization. Income from operations was $214.7 million in the quarter. As of September 30, 2023, the company had cash and cash equivalents of $3.23 billion, marketable securities of $289.2 million, and an accumulated deficit of $40.7 million, down from $437.2 million at December 31, 2022. Net cash provided by operating activities was $348.8 million for the nine months, compared with $686.3 million a year earlier, which the filing attributes primarily to changes in working capital. The company had no outstanding borrowings under its $500.0 million revolving credit facility. The filing highlights several risks, including a contract dispute with Novartis over accrued royalties on U.S. JAKAFI net sales, which totaled $341.5 million in accrued royalties at September 30, 2023. The company also disclosed a lawsuit against CMS over the treatment of OPZELURA as a line extension of JAKAFI, with approximately $42.9 million accrued. In addition, a complete response letter was received in March 2023 for ruxolitinib extended-release tablets, and the company discontinued two Phase III LIMBER studies of ruxolitinib combined with parsaclisib.

    Oct 31, 2023
  11. 2023-Q2

    Incyte Quarterly Report for Q2 Ended Jun 30, 2023

    Incyte Corporation's Form 10-Q for the quarter ended June 30, 2023 reports total revenues of $954.6 million for the three months ended June 30, 2023, up from $911.4 million in the prior-year quarter, and net income of $203.5 million, or $0.90 per diluted share, compared with $161.4 million, or $0.72 per diluted share, a year earlier. Product revenues, net were $827.0 million for the quarter, led by JAKAFI at $682.4 million and OPZELURA at $80.2 million. Total product royalty revenues were $127.6 million, and no milestone and contract revenues were recognized in the quarter, compared with $130.0 million in the prior-year period. Research and development expense rose to $400.8 million for the quarter from $347.2 million, and selling, general and administrative expense rose to $283.9 million from $253.3 million, with the filing attributing the SG&A increase primarily to the establishment of the dermatology commercial organization and launch promotion for OPZELURA. Interest income and other, net was $42.7 million for the quarter, versus $0.5 million a year earlier. At June 30, 2023, cash, cash equivalents and marketable securities totaled $3.4 billion, the company had no outstanding borrowings under its $500.0 million revolving credit facility, and net cash provided by operating activities for the six months was $200.9 million, down from $389.9 million, which the filing attributes primarily to working capital changes. The filing highlights concentration in JAKAFI, which the company states it expects will continue to contribute a significant percentage of total revenues. It also discloses a March 2023 complete response letter for ruxolitinib XR tablets, a discontinued Phase III LIMBER study, and ongoing government rebate and sales allowance pressures, including a Novartis dispute over $310.3 million of accrued royalties classified in current liabilities.

    Aug 1, 2023
  12. 2023-Q1

    Incyte Quarterly Report for Q1 Ended Mar 31, 2023

    Incyte Corporation's Form 10-Q for the quarter ended March 31, 2023 reports total revenues of $808.7 million, up from $733.2 million in the prior-year quarter. Product revenues, net were $693.2 million, led by JAKAFI at $580.0 million and OPZELURA at $56.6 million, compared with $12.8 million for OPZELURA a year earlier. Product royalty revenues were $115.4 million, and the company reported no milestone and contract revenues in the quarter versus $5.0 million in the prior year. Net income was $21.7 million, or $0.10 per diluted share, compared with $38.0 million, or $0.17 per diluted share, in the first quarter of 2022. Research and development expense rose to $406.6 million and selling, general and administrative expense rose to $315.6 million, which the filing attributes largely to dermatology commercial build-out and OPZELURA launch promotion. Interest income and other, net increased to $32.9 million from $1.3 million. Net cash used in operating activities was $105.6 million, compared with $215.7 million provided in the prior-year period, due mainly to a reduction in accounts payable. At March 31, 2023, cash, cash equivalents and marketable securities totaled $3.1 billion, and the company had no outstanding borrowings under its $500.0 million revolving credit facility. The filing also discloses a complete response letter from the FDA in March 2023 for ruxolitinib extended-release tablets, and the discontinuation of two Phase III LIMBER studies of ruxolitinib combined with parsaclisib.

    May 2, 2023
  13. 2022-Q3

    Incyte Quarterly Report for Q3 Ended Sep 30, 2022

    Incyte Corporation's Form 10-Q for the quarter ended September 30, 2022 reports total revenues of $823.3 million for the three months ended September 30, 2022, compared with $813.0 million in the prior-year period, and net income of $112.8 million ($0.50 diluted EPS), down from $181.7 million ($0.82 diluted EPS). For the nine months, total revenues were $2.47 billion and net income was $312.2 million ($1.40 diluted EPS). Product revenues, net, were $713.0 million for the quarter, led by JAKAFI at $619.6 million, with OPZELURA contributing $38.1 million. Product royalty revenues fell to $110.3 million from $184.0 million, mainly due to lower OLUMIANT royalties. Research and development expense rose to $384.0 million and SG&A to $266.5 million, reflecting continued late-stage development spending and the build-out of the dermatology commercial organization for OPZELURA. As of September 30, 2022, cash and cash equivalents were $2.69 billion, and the company reported available cash, cash equivalents and marketable securities of $3.0 billion. Total stockholders' equity was $4.23 billion, and the accumulated deficit narrowed to $465.7 million. Net cash provided by operating activities was $686.3 million for the nine months. The company had no outstanding borrowings under its $500.0 million revolving credit facility. Subsequent to quarter end, Incyte agreed to acquire Villaris Therapeutics, Inc., with a $70.0 million upfront payment and up to $310.0 million in development and regulatory milestones plus up to $1.05 billion in commercial milestones, subject to Hart-Scott-Rodino clearance. The filing also notes the planned termination of the Calithera collaboration effective December 2022 and the termination of the OX40 project under the Agenus agreement.

    Nov 1, 2022
  14. 2022-Q2

    Incyte Quarterly Report for Q2 Ended Jun 30, 2022

    Incyte Corporation's Form 10-Q for the quarter ended June 30, 2022 reports total revenues of $911.4 million for the three months ended June 30, 2022, up from $705.7 million in the prior-year period, and net income of $161.4 million, or $0.72 per diluted share, compared with $149.5 million, or $0.67 per diluted share, a year earlier. For the six months, total revenues were $1.64 billion and net income was $199.4 million, or $0.89 per diluted share. Product revenues, net, were $663.9 million in the quarter, with JAKAFI contributing $597.7 million. Milestone and contract revenues rose to $130.0 million in the quarter, driven by regulatory milestones under the Novartis and Lilly agreements, including $40.0 million for FDA approval of OLUMIANT in severe alopecia areata. Selling, general and administrative expenses rose to $253.3 million in the quarter from $168.9 million, primarily reflecting the dermatology commercial organization and the launch of OPZELURA. Research and development expense was $347.2 million. Unrealized losses on long term investments were $24.9 million in the quarter and $71.5 million for the six months, driven by declines in the fair value of holdings in collaboration partners such as Merus and MorphoSys. Provision for income taxes increased to $67.9 million in the quarter, reflecting the release of a valuation allowance against most U.S. research and development tax credit carryforwards and other deferred tax assets at December 31, 2021. At June 30, 2022, cash, cash equivalents and marketable securities totaled $2.7 billion, total assets were $5.32 billion, and stockholders' equity was $4.09 billion, with an accumulated deficit of $578.5 million. Operating cash flow for the six months was $389.9 million. The company had no borrowings outstanding under its $500.0 million revolving credit facility. The filing also discloses a July 2022 amendment with MacroGenics under which Incyte paid $30.0 million, and the July 2022 withdrawal of the parsaclisib marginal zone lymphoma application in the EU.

    Aug 2, 2022
  15. 2022-Q1

    Incyte Quarterly Report for Q1 Ended Mar 31, 2022

    Incyte Corporation's Form 10-Q for the quarter ended March 31, 2022 reports total revenues of $733.2 million, up from $604.7 million in the prior-year quarter, led by JAKAFI product revenues of $544.5 million. Net income was $38.0 million, or $0.17 per diluted share, compared with $53.5 million, or $0.24 per diluted share, a year earlier. The decline in net income reflects higher research and development expense of $353.4 million, higher selling, general and administrative expense of $209.6 million, a $46.6 million unrealized loss on long term investments in collaboration partners, and a higher tax provision of $32.5 million, which the company attributes to the release of its valuation allowance against most U.S. research and development tax credit carryforwards and other deferred tax assets at December 31, 2021. The company ended the quarter with cash, cash equivalents and marketable securities of $2.5 billion, operating cash flow of $215.7 million, and total stockholders' equity of $3.86 billion. Its $500.0 million senior unsecured revolving credit facility had no outstanding borrowings. Management described the company as adequately capitalized for the foreseeable future. Sales allowances and accruals rose to $170.1 million at March 31, 2022, and the company launched OPZELURA (ruxolitinib) cream for atopic dermatitis in October 2021, with a PDUFA target action date of July 18, 2022 for its vitiligo indication. For investors, the key drivers are continued dependence on JAKAFI, the growth of newer products including OPZELURA, PEMAZYRE and MONJUVI/MINJUVI, and spending on late-stage development. The filing also notes the company's Yverdon, Switzerland large molecule production facility, which it expects to be GMP approved in the second half of 2022.

    May 3, 2022
  16. 2021-Q3

    Incyte Quarterly Report for Q3 Ended Sep 30, 2021

    Incyte Corporation's Form 10-Q for the quarter ended September 30, 2021 reports total revenues of $812,987 thousand for the three months ended September 30, 2021, up from $620,643 thousand a year earlier, and net income of $181,739 thousand ($0.82 per diluted share), compared with a net loss of $15,203 thousand in the prior-year quarter. For the nine months, total revenues were $2.12 billion and net income was $384.7 million ($1.73 per diluted share), versus a net loss of $445.5 million in the prior-year period. JAKAFI product revenues were $547.4 million in the quarter, and total product royalty revenues were $184.0 million, driven by OLUMIANT royalties of $86.6 million. Research and development expense fell to $334.9 million in the quarter from $438.1 million, largely because the prior-year period included upfront and milestone expenses for collaborations and the purchase of a priority review voucher. The balance sheet at September 30, 2021 shows cash and cash equivalents of $1.999 billion and total assets of $4.199 billion, with total stockholders' equity of $3.149 billion. Net cash provided by operating activities was $634.1 million for the nine months, compared with a $231.9 million outflow a year earlier. The company entered an unsecured $500.0 million three-year revolving credit facility in August 2021, with no borrowings outstanding at quarter end. The filing also discloses a September 2021 Collaboration and License Agreement with Syndax Pharmaceuticals, which includes a $117.0 million upfront payment upon effectiveness, and a September 2021 FDA approval of JAKAFI for chronic graft-versus-host disease. The filing reports that the company's accumulated deficit was $1.3 billion at September 30, 2021, and it identifies JAKAFI as the company's dominant revenue source, with risk factors flagging its concentration, competition, generic challenges, and the September 2021 FDA labeling update on JAK-inhibitor warnings.

    Nov 2, 2021
  17. 2021-Q2

    Incyte Quarterly Report for Q2 Ended Jun 30, 2021

    Incyte Corporation's Form 10-Q for the quarter ended June 30, 2021 reports total revenues of $705.7 million for the three months ended June 30, 2021, up from $688.0 million a year earlier, and $1.31 billion for the six months, versus $1.26 billion in the prior-year period. Product revenues, net were $575.2 million in the quarter, driven by JAKAFI revenues of $529.1 million, while product royalty revenues were $120.6 million, including OLUMIANT and JAKAVI royalties. Net income was $149.5 million for the quarter ($0.67 diluted per share) and $203.0 million for the six months, compared with a net loss of $430.3 million in the first half of 2020, which had included a large research and development charge tied to the MorphoSys agreement. The balance sheet remained strong, with cash and cash equivalents of $1.80 billion and marketable securities of $283.4 million at June 30, 2021, and an accumulated deficit of $1.5 billion. Operating cash flow was $379.0 million for the six months, and capital expenditures were $114.4 million, largely for construction projects in Wilmington, Delaware and Yverdon, Switzerland. Research and development expense was $343.5 million in the quarter, and selling, general and administrative expense was $168.9 million, reflecting commercialization activity for JAKAFI and preparation for dermatology launches. The filing highlights regulatory events in the period, including the FDA extending the PDUFA date for ruxolitinib cream in atopic dermatitis to September 2021, a complete response letter for retifanlimab in anal canal squamous cell carcinoma, and a settlement of $12.6 million with the DOJ. The company also notes that a full valuation allowance continues against its U.S. and Swiss net deferred tax assets, and that JAKAFI remains its principal revenue source.

    Aug 3, 2021
  18. 2021-Q1

    Incyte Quarterly Report for Q1 Ended Mar 31, 2021

    Incyte Corporation's Form 10-Q for the quarter ended March 31, 2021 reports total revenues of $604.7 million, up from $568.5 million in the prior-year quarter. Product revenues, net were $504.8 million, led by JAKAFI at $465.7 million, while product royalty revenues were $99.9 million, including $65.6 million from JAKAVI, $32.3 million from OLUMIANT and $2.0 million from TABRECTA. The company swung to net income of $53.5 million, or $0.24 per diluted share, compared with a net loss of $720.6 million, or $3.33 per share, in the prior-year period. That prior-year loss reflected a $750.0 million upfront payment to MorphoSys recorded in research and development expense, while research and development expense for the current quarter was $306.9 million. At March 31, 2021, the company held cash and cash equivalents of $1.67 billion and marketable securities of $292.4 million, which it describes as total available cash, cash equivalents and marketable securities of $2.0 billion. Total assets were $3.66 billion and stockholders' equity was $2.73 billion. Operating cash flow was $206.1 million for the quarter, compared with cash used of $683.4 million a year earlier. The company still reports an accumulated deficit of $1.7 billion. Management states it believes operating cash flow plus existing cash and securities will be adequate for its capital needs for the foreseeable future. The filing also highlights regulatory and pipeline developments, including a PDUFA action date of June 21, 2021 for ruxolitinib cream in mild-to-moderate atopic dermatitis, an FDA priority review of retifanlimab for previously treated squamous cell carcinoma of the anal canal, and March 2021 approvals of PEMAZYRE in Japan and the European Union. It also discloses a $13.2 million reserve related to a Department of Justice qui tam matter, for which the company has reached a settlement in principle with the DOJ Civil Division.

    May 4, 2021
  19. 2020-Q3

    Incyte Quarterly Report for Q3 Ended Sep 30, 2020

    Incyte Corporation's Form 10-Q for the quarter ended September 30, 2020 shows a sharp swing to losses driven by research and development spending. Total revenues were $620.6 million for the three months ended September 30, 2020, versus $551.6 million a year earlier, and $1.88 billion for the nine months, versus $1.58 billion. Product revenues, net, were $522.3 million for the quarter, led by JAKAFI at $487.8 million. However, the company reported a net loss of $15.2 million for the quarter ($0.07 per share) compared with net income of $128.3 million a year earlier, and a nine-month net loss of $445.5 million ($2.05 per share) versus net income of $335.9 million. Nine-month R&D expense rose to $1.81 billion from $841.2 million, reflecting an upfront payment of $750.0 million to MorphoSys in March 2020 and the cost of a $120.0 million FDA priority review voucher purchased in the third quarter. The balance sheet remained strong, with cash and cash equivalents of $1.50 billion and marketable securities of $237.0 million at September 30, 2020, against total liabilities of $916.6 million and stockholders' equity of $2.39 billion. Cash used in operating activities was $231.9 million for the nine months, compared with $579.0 million provided a year earlier, and capital expenditures were $135.9 million, largely for facilities in Morges and Yverdon, Switzerland. Management states it believes cash flow from operations and existing cash, cash equivalents and marketable securities will be adequate for the foreseeable future. Key pipeline and regulatory developments in the period included FDA approval of PEMAZYRE in April 2020, FDA approval of MONJUVI in July 2020, and TABRECTA approvals in the U.S. and Japan. The filing also discloses a Department of Justice civil investigative demand and a qui tam complaint relating to speaker and patient assistance programs, for which no reserve has been recorded, and states that the company cannot predict the outcome.

    Nov 5, 2020
  20. 2020-Q2

    Incyte Quarterly Report for Q2 Ended Jun 30, 2020

    Incyte Corporation's Form 10-Q for the quarter ended June 30, 2020 shows a sharp swing in results driven by a $750.0 million upfront payment to MorphoSys in March 2020. Total revenues for the six months ended June 30, 2020 were $1,256.6 million, up from $1,027.8 million a year earlier, with product revenues of $987.0 million (JAKAFI $933.2 million), product royalty revenues of $174.5 million and milestone and contract revenues of $95.0 million. Research and development expense rose to $1,371.9 million for the six months (versus $559.9 million), which produced a net loss of $430.3 million, or $1.98 per share, compared with net income of $207.6 million in the prior-year period. For the three months ended June 30, 2020, the company reported net income of $290.3 million, or $1.32 per diluted share, on revenues of $688.0 million. Balance sheet and cash flow data show cash and cash equivalents of $1,326.7 million at June 30, 2020, and marketable securities of $262.8 million, which the filing describes as available cash, cash equivalents and marketable securities of $1.6 billion. Net cash used in operating activities was $414.0 million for the six months, which the filing attributes primarily to the MorphoSys cash outflow and working capital changes. Total stockholders' equity was $2,344.6 million and the accumulated deficit reached $1.9 billion. The company states it believes its cash flow from operations and existing cash and marketable securities will be adequate for its capital needs for the foreseeable future. Pipeline and regulatory activity in the period included the FDA approval of PEMAZYRE in April 2020, the FDA approval of TABRECTA in May 2020, and the July 2020 FDA accelerated approval of MONJUVI (tafasitamab) with lenalidomide. The filing also discloses a qui tam complaint tied to a DOJ civil investigative demand concerning speaker and patient assistance programs, for which no reserve has been recorded, and notes that the company cannot predict the outcome.

    Aug 4, 2020
  21. 2020-Q1

    Incyte Quarterly Report for Q1 Ended Mar 31, 2020

    Incyte Corporation's Form 10-Q for the quarter ended March 31, 2020 shows a sharp swing to a loss. The company reported a net loss of $720.6 million, or $3.33 per share, compared with net income of $102.3 million, or $0.48 basic per share, in the first quarter of 2019. Total revenues were $568.5 million, up from $497.8 million, led by JAKAFI net revenues of $459.5 million and total product royalty revenues of $81.8 million. The loss was driven mainly by research and development expense of $1,085.3 million, which included a $750.0 million upfront payment to MorphoSys in March 2020 for tafasitamab rights, recorded in R&D. Cash and cash equivalents fell to $1.04 billion at March 31, 2020 from $1.83 billion at year-end 2019, and net cash used in operating activities was $683.4 million, reflecting the MorphoSys payment and working capital changes. Including marketable securities of $259.4 million, available cash, cash equivalents and marketable securities totaled $1.3 billion. The accumulated deficit reached $2.15 billion, and stockholders' equity declined to $1.94 billion from $2.60 billion. Management said it believes operating cash flow and existing cash will be adequate for the foreseeable future. Other developments in the filing include the April 2020 FDA approval of PEMAZYRE (pemigatinib) for previously treated cholangiocarcinoma with an FGFR2 fusion or rearrangement, and the initiation of COVID-19 trials of ruxolitinib. The filing also reports the 1.25% convertible senior notes due 2020 becoming convertible on April 1, 2020, and a Department of Justice civil investigative demand related to speaker and patient assistance programs, with no reserve recorded.

    May 5, 2020
  22. 2019-Q3

    Incyte Quarterly Report for Q3 Ended Sep 30, 2019

    Incyte Corporation filed this Form 10-Q for the quarter ended September 30, 2019. For the nine months ended September 30, 2019, total revenues were $1.58 billion, up from $1.35 billion in the prior-year period, and net income was $335.9 million (diluted EPS of $1.55), compared with $40.4 million ($0.19) a year earlier. Product revenues, net, were $1.28 billion, driven by JAKAFI revenues of $1.22 billion, and product royalty revenues were $217.7 million, including $56.8 million from OLUMIANT. Milestone and contract revenues were $77.5 million for the nine months, versus $120.0 million in the prior-year period. Research and development expense declined to $841.2 million from $893.7 million, reflecting upfront and milestone expenses recorded in 2018 and the end of additional baricitinib co-funding with Lilly effective January 1, 2019. As of September 30, 2019, Incyte reported cash and cash equivalents of $1.70 billion and marketable securities of $284.2 million, with available cash, cash equivalents and marketable securities of $2.0 billion. Net cash provided by operating activities was $579.0 million for the nine months, versus $252.4 million a year earlier. The company had an accumulated deficit of $1.5 billion and total stockholders' equity of $2.42 billion. A full valuation allowance remains against U.S. and Swiss net deferred tax assets, and the filing notes that the company may release all or a portion of it in the near term, which would produce a non-cash increase to net income. Key pending items include a December 2018 civil investigative demand from the U.S. Department of Justice regarding speaker and patient assistance programs, for which no reserve has been recorded, and an October 2019 agreement to purchase property for $50.0 million to expand the global headquarters. The filing also reports that REACH2 met its primary endpoint in steroid-refractory acute GVHD, and that JAKAFI received FDA approval for steroid-refractory acute GVHD in May 2019.

    Oct 29, 2019
  23. 2019-Q2

    Incyte Quarterly Report for Q2 Ended Jun 30, 2019

    Incyte Corporation's Form 10-Q for the quarter ended June 30, 2019 reports net income of $105.3 million for the three months ended June 30, 2019, compared with $52.4 million in the same period of 2018, and net income of $207.6 million for the six months, compared with $11.3 million a year earlier. Total revenues were $529.9 million for the quarter and $1.03 billion for the six months. Product revenues, net, were $433.9 million for the quarter, driven by JAKAFI revenues of $409.5 million, while product royalty revenues were $76.0 million, including $56.9 million from JAKAVI and $19.1 million from OLUMIANT. Milestone and contract revenues were $20.0 million in the quarter, down from $100.0 million a year earlier. Cash, cash equivalents and marketable securities totaled $1.7 billion at June 30, 2019, and the company reported net cash provided by operating activities of $308.6 million for the six months, versus $53.2 million in 2018. The accumulated deficit narrowed to $1.67 billion from $1.88 billion at year-end 2018. Management states it believes cash flow from operations and existing cash will be adequate for the foreseeable future. The filing also notes that the company elected in April 2019 to end additional co-funding of baricitinib development with Lilly effective January 1, 2019, that the 1.25% Convertible Senior Notes due 2020 became convertible on July 1, 2019, and that a Department of Justice civil investigative demand relating to speaker and patient assistance programs remains ongoing with no reserve recorded. A subsequent event describes a July 2019 collaboration with Zai Lab for INCMGA0012, with an expected $17.5 million upfront payment in the third quarter of 2019.

    Jul 30, 2019
  24. 2019-Q1

    Incyte Quarterly Report for Q1 Ended Mar 31, 2019

    Incyte Corporation's Form 10-Q for the quarter ended March 31, 2019 reports a return to profitability. Total revenues were $497.9 million, up from $382.3 million in the prior-year quarter, driven by product revenues of $396.2 million (JAKAFI $375.6 million, ICLUSIG $20.6 million), product royalty revenues of $61.6 million, and $40.0 million in milestone and contract revenue from the Innovent collaboration. Net income was $102.3 million, or $0.47 per diluted share, compared with a net loss of $41.1 million, or $0.19 per share, a year earlier. Research and development expense fell to $270.5 million from $303.1 million, largely because upfront and milestone collaboration expenses recorded in 2018 did not recur and because Incyte elected to end additional co-funding of baricitinib with Lilly effective January 1, 2019. The balance sheet strengthened, with cash and cash equivalents of $1.30 billion and marketable securities of $281.3 million at March 31, 2019, and total stockholders' equity of $2.09 billion. Operating cash flow was $155.7 million versus $20.8 million in the prior-year period. The accumulated deficit was $1.8 billion. Management stated that cash flow from operations and existing cash, cash equivalents and marketable securities will be adequate for its capital needs for the foreseeable future. Key risks disclosed include reliance on JAKAFI for most revenue, a pending ANDA challenge to JAKAFI patents, competition including fedratinib, and a December 2018 civil investigative demand from the U.S. Department of Justice relating to speaker and patient assistance programs, for which no reserve has been recorded. The 2020 convertible notes became convertible through at least June 30, 2019.

    Apr 30, 2019
  25. 2018-Q3

    Incyte Quarterly Report for Q3 Ended Sep 30, 2018

    Incyte Corporation's Form 10-Q for the quarter ended September 30, 2018 reports total revenues of $449.7 million for the three months ended September 30, 2018, up from $381.5 million a year earlier, and $1.35 billion for the nine months, up from $1.09 billion. Product revenues, net were $367.7 million for the quarter, driven by JAKAFI revenues of $347.6 million and ICLUSIG revenues of $20.1 million. Milestone revenues were $20.0 million in the quarter and $120.0 million year to date, and product royalty revenues were $61.9 million for the quarter, including $50.9 million from JAKAVI and $11.0 million from OLUMIANT. The company recorded net income of $29.2 million, or $0.14 per diluted share, for the quarter and $40.4 million, or $0.19 per diluted share, for the nine months, compared with a net loss of $163.5 million for the nine months of 2017. Research and development expense was $292.5 million for the quarter and $893.7 million for the nine months, while selling, general and administrative expense was $96.5 million and $326.0 million, respectively. The balance sheet showed cash and cash equivalents of $1.11 billion and marketable securities of $263.1 million at September 30, 2018, and the company stated it had available cash, cash equivalents and marketable securities of $1.4 billion. Net cash provided by operating activities was $252.4 million for the nine months, compared with net cash used of $3.7 million a year earlier. The company reported an accumulated deficit of $1.9 billion and a full valuation allowance against its U.S. and Swiss net deferred tax assets. The filing also discloses regulatory and pipeline developments, including an FDA approval of the 2mg dose of OLUMIANT (baricitinib) in June 2018 and an sNDA for ruxolitinib in steroid-refractory acute GVHD accepted for Priority Review in October 2018. Incyte also stopped the ECHO-301 study of epacadostat with Merck in April 2018 and significantly downsized that development program. Risk factors highlight dependence on JAKAFI, the potential for generic competition following a patent challenge, and reliance on collaborators such as Novartis and Eli Lilly for royalty and milestone revenue.

    Oct 30, 2018
  26. 2018-Q2

    Incyte Quarterly Report for Q2 Ended Jun 30, 2018

    Incyte Corporation's Form 10-Q for the quarter ended June 30, 2018 reports a return to profitability on a quarterly basis. Total revenues for the three months ended June 30, 2018 were $521.5 million, up from $326.4 million in the prior-year period, driven by $100.0 million in milestone revenue from Eli Lilly tied to the FDA approval of the 2mg dose of OLUMIANT (baricitinib), plus product revenues of $365.5 million, primarily JAKAFI at $345.6 million. The company reported net income of $52.4 million, or $0.24 per diluted share, for the quarter, compared with a net loss of $12.5 million in the second quarter of 2017. For the six months ended June 30, 2018, net income was $11.3 million, compared with a net loss of $199.6 million a year earlier, which included large upfront and milestone payments to collaborators. Research and development expense rose to $298.1 million in the quarter from $201.8 million, while selling, general and administrative expense rose to $108.0 million from $90.1 million. The filing attributes the R&D increase largely to clinical research and outside services and to development headcount. At June 30, 2018, cash, cash equivalents and marketable securities totaled $1.2 billion, and the company reported an accumulated deficit of $2.0 billion. Management states it believes operating cash flow and existing cash will be adequate for at least the next twelve months. The filing also discloses concentration in JAKAFI sales and royalty streams from Novartis (JAKAVI) and Lilly (OLUMIANT). It notes that the ECHO-301 epacadostat trial did not meet its primary endpoint in April 2018, leading to a downsized program, and that the FDA approved only the 2mg OLUMIANT dose with a warning label. Investors should weigh the strong quarterly result against its reliance on milestone timing and on JAKAFI, as well as the pending generic patent challenge described in the risk factors.

    Jul 31, 2018
  27. 2018-Q1

    Incyte Quarterly Report for Q1 Ended Mar 31, 2018

    Incyte Corporation reported a net loss of $41.1 million, or $0.19 per share, for the three months ended March 31, 2018, compared with a net loss of $187.1 million, or $0.96 per share, in the same period of 2017. Total revenues were $382.3 million, roughly flat against $384.1 million a year earlier. Product revenues, net rose to $334.5 million from $264.8 million, driven by JAKAFI revenues of $313.7 million and ICLUSIG revenues of $20.8 million. Product royalty revenues increased to $47.7 million from $29.2 million, but the company recognized no milestone revenue in the quarter, versus $90.0 million in the prior-year period. Research and development expenses fell to $303.1 million from $407.9 million, largely because of upfront and milestone expenses tied to collaboration agreements recorded in the first quarter of 2017. As of March 31, 2018, cash, cash equivalents and marketable securities totaled $1.2 billion, and the company reported net cash provided by operating activities of $20.8 million. The accumulated deficit stood at $2.0 billion. The filing discloses several pipeline and regulatory developments after quarter end: in April 2018 Incyte and Merck announced that the ECHO-301 study of epacadostat did not meet its primary endpoint and that the epacadostat development program was being significantly downsized. The FDA Arthritis Advisory Committee recommended approval of the 2mg dose of baricitinib but not the 4mg dose, and the FDA action date is in June 2018. The company also paid BMS a $15.0 million option exercise fee in April 2018. The filing also notes that the 2018 and 2020 convertible senior notes became convertible through at least June 30, 2018, and that the 2018 Notes are classified as short-term liabilities because they mature in November 2018.

    May 1, 2018
  28. 2017-Q3

    Incyte Quarterly Report for Q3 Ended Sep 30, 2017

    Incyte Corporation's Quarterly Report on Form 10-Q for the period ended September 30, 2017 shows a sharp swing in profitability for the nine months. Total revenues were $1,092.1 million for the nine months ended September 30, 2017, up from $779.2 million, driven by product revenues, net of $878.5 million (JAKAFI $831.0 million and ICLUSIG $47.5 million), product royalty revenues of $108.5 million, and contract revenues of $105.0 million. However, research and development expenses rose to $879.4 million for the nine months, and the company reported a net loss of $163.5 million, or $0.81 per share, compared with net income of $95.3 million in the prior-year period. The third quarter was profitable, with net income of $36.1 million, or $0.17 per diluted share, on total revenues of $381.5 million. Results for the nine months include charges tied to new or amended collaboration agreements with Calithera, Merus and Agenus, totaling $209.1 million, and a $54.9 million expense related to senior note conversions. The balance sheet strengthened considerably. Cash and cash equivalents rose to $1,128.0 million at September 30, 2017, from $652.3 million at December 31, 2016, reflecting net proceeds of approximately $649.4 million from a September 2017 public offering of 4,945,000 shares at $131.46 per share. Convertible senior notes fell to $23.7 million from $651.5 million as holders converted or exchanged notes into common stock, and shares outstanding increased to 211,019,366. The company reported an accumulated deficit of $1.8 billion and stated that it believes cash flow from operations, together with its cash, cash equivalents and marketable securities, will be adequate to meet capital needs for at least the next twelve months. Net cash used by operating activities was $3.7 million for the nine months. Key pipeline and regulatory developments in the filing include the discontinuation of the OPTIC-2L study, which led to a $12.0 million write-off of acquired in-process research and development and a $24.0 million benefit in the change in fair value of acquisition-related contingent consideration in the third quarter. The FDA issued a complete response letter for baricitinib (OLUMIANT) for rheumatoid arthritis in April 2017, and a resubmission is now expected before the end of January 2018. In October 2017, the company agreed to license MGA012, a PD-1 antibody, from MacroGenics with a $150.0 million upfront payment, expected to close in the fourth quarter of 2017 subject to regulatory waiting periods.

    Oct 31, 2017
  29. 2017-Q2

    Incyte Quarterly Report for Q2 Ended Jun 30, 2017

    Incyte Corporation's Form 10-Q for the quarter ended June 30, 2017 reports a net loss of $12.5 million ($0.06 per share) for the three months ended June 30, 2017, compared with net income of $34.4 million ($0.18 per share) a year earlier. For the six months ended June 30, 2017, the net loss was $199.6 million ($1.00 per share), versus net income of $58.5 million in the prior-year period. Total revenues were $326.4 million for the quarter and $710.5 million for the six months. Product revenues, net were $291.7 million for the quarter, driven by JAKAFI revenues of $276.0 million and ICLUSIG revenues of $15.7 million. Research and development expense rose to $609.8 million for the six months from $277.1 million, primarily reflecting upfront and milestone charges of $209.1 million under the new Calithera and Merus agreements and the amended Agenus agreement. Balance sheet and liquidity: cash and cash equivalents were $451.8 million and marketable securities were $156.9 million at June 30, 2017, for available cash, cash equivalents and marketable securities of $608.6 million. Net cash used in operating activities was $56.8 million for the six months, compared with $115.1 million provided in the prior-year period. Convertible senior notes fell to $23.4 million from $651.5 million at year-end 2016, following note exchanges for common stock. The company states that the 2018 and 2020 Notes became convertible through at least September 30, 2017 and that it intends to settle conversions in shares. Management believes cash flow from operations and existing resources will be adequate for at least the next twelve months. Regulatory and pipeline developments disclosed include a FDA complete response letter for baricitinib (OLUMIANT) in rheumatoid arthritis, with resubmission now expected to be delayed by a minimum of 18 months, and European and Japanese approvals of baricitinib. The filing also notes a Paragraph IV challenge to certain JAKAFI patents, with the composition of matter patent expiring December 24, 2027.

    Aug 1, 2017
  30. 2017-Q1

    Incyte Quarterly Report for Q1 Ended Mar 31, 2017

    Incyte Corporation reported a net loss of $187.1 million, or $0.96 per share, for the three months ended March 31, 2017, compared with net income of $24.0 million, or $0.12 diluted per share, in the same period of 2016. Total revenues rose to $384.1 million from $263.5 million. Product revenues, net were $264.8 million, including JAKAFI revenues of $251.1 million and ICLUSIG revenues of $13.7 million, which reflects the June 2016 acquisition of ARIAD's European operations. Contract revenues were $90.0 million, driven by milestone payments from Lilly and Novartis, and product royalty revenues were $29.2 million. The loss was driven mainly by research and development expense of $408.0 million, which rose from $156.8 million. The filing attributes the increase primarily to upfront and milestone charges under new or amended collaborations with Calithera, Merus and Agenus, which together totaled $209.1 million in the quarter. The company also recorded $54.1 million of expense related to senior note conversions. Cash and cash equivalents fell to $361.8 million from $652.3 million at year-end 2016, and operating cash flow was negative $173.6 million, against $97.5 million provided in the prior-year quarter. At March 31, 2017, the company had $512.0 million in cash, cash equivalents and marketable securities and stated it believes these are adequate for at least the next twelve months. Balance sheet changes were significant. Convertible senior notes fell to $41.6 million from $651.5 million after note exchanges, and stockholders' equity increased to $965.9 million from $419.5 million, reflecting the conversion of notes into common stock. Shares outstanding rose to 204,563,710 from 188,848,752. The filing also reports an April 2017 FDA complete response letter for baricitinib in rheumatoid arthritis, which the company and Lilly dispute, and states that the 2018 and 2020 convertible notes became convertible through at least June 30, 2017.

    May 4, 2017
  31. 2016-Q2-A

    Incyte Quarterly Report (Amendment) for Q2 Ended Jun 30, 2016

    Incyte Corporation filed this Amendment No. 1 on Form 10-Q/A, dated February 14, 2017, to amend its Form 10-Q for the quarter ended June 30, 2016. The original report was filed with the SEC on August 9, 2016. The company states that the amendment is filed solely to amend Exhibit 10.3 under Item 6 of Part II in connection with a request for confidential treatment of portions of that exhibit. It makes no other changes, does not update disclosures, and speaks as of the original filing date. The filing's substantive content is an exhibit list rather than financial results. It identifies several agreements from the second quarter of 2016: an April 5, 2016 amendment to the Collaboration and License Agreement with Novartis International Pharmaceutical Ltd., a May 9, 2016 Share Purchase Agreement among Incyte Europe S.à r.l., ARIAD Pharmaceuticals entities, and Incyte as guarantor, and a June 1, 2016 Amended and Restated Buy-In License Agreement with ARIAD Pharmaceuticals, Inc. and ARIAD Pharmaceuticals (Europe) Sarl. Confidential treatment has been requested for portions of several of these agreements. The exhibit list also includes management compensation arrangements and the XBRL files. The cover page reports 188,002,918 shares of Common Stock outstanding as of August 2, 2016, and identifies Incyte as a large accelerated filer. The report is signed by Hervé Hoppenot, Chairman, President, and Chief Executive Officer, and David W. Gryska, Chief Financial Officer.

    Feb 14, 2017
  32. 2016-Q3

    Incyte Quarterly Report for Q3 Ended Sep 30, 2016

    Incyte Corporation's Form 10-Q for the quarter ended September 30, 2016 reports a return to profitability on strong JAKAFI sales. Total revenues for the three months ended September 30, 2016 were $269.5 million, up from $187.6 million, and net income was $36.9 million, or $0.20 basic per share, compared with a net loss of $39.6 million a year earlier. For the nine months, total revenues were $779.2 million and net income was $95.3 million. Product revenues, net, reached $236.6 million for the quarter, with JAKAFI contributing $223.9 million and ICLUSIG contributing $12.7 million following the June 1, 2016 acquisition of ARIAD's European operations. The acquisition was completed for an upfront payment of $147.5 million, with contingent consideration valued at $293.0 million, and generated goodwill of $155.7 million and intangible assets of $283.0 million. Cash, cash equivalents and marketable securities totaled $716.6 million at September 30, 2016. Convertible senior notes carried a principal amount of $749.8 million, and the company recorded an accumulated deficit of $1.7 billion. Management stated that existing cash and marketable securities are adequate to satisfy capital needs for at least the next twelve months. The filing also highlights key risks and developments: a Paragraph IV notice challenging patents on a generic version of Jakafi, the discontinuation of certain ruxolitinib studies in oncology, and the planned start of a U.S. registration program for ruxolitinib in graft-versus-host disease in the fourth quarter of 2016. A subsequent event disclosed a $40.0 million regulatory milestone from Novartis, expected to be recorded as contract revenue in the fourth quarter of 2016.

    Nov 1, 2016
  33. 2016-Q2

    Incyte Quarterly Report for Q2 Ended Jun 30, 2016

    Incyte Corporation's Form 10-Q for the quarter ended June 30, 2016 reports a return to profitability for the six months, with net income of $58.5 million, or $0.30 diluted per share, compared with a net loss of $9.1 million in the prior-year period. Total revenues were $246.3 million for the three months ended June 30, 2016 and $509.8 million for the six months, driven by JAKAFI product revenues of $395.4 million in product revenues, net for the six months (up from $257.7 million), along with contract revenues of $66.4 million for the six months, largely from Lilly and Novartis milestones. Operating income for the quarter was $44.6 million, versus a loss of $7.4 million a year earlier. The quarter's most significant event was the June 1, 2016 acquisition of the European operations of ARIAD Pharmaceuticals, which gives Incyte exclusive rights to ICLUSIG (ponatinib) in the EU and other territories for an upfront payment of $147.5 million. The filing records $293.0 million of contingent consideration related to the license, $283.0 million of acquired intangible assets, and $155.7 million of goodwill, all on a provisional basis. ARIAD's European subsidiaries contributed $4.0 million of revenue and a $7.9 million net loss from the acquisition date through June 30, 2016. Total assets rose to $1.42 billion at June 30, 2016 from $1.01 billion at December 31, 2015, while total liabilities increased to $1.12 billion, including acquisition-related contingent consideration. Investors should also note several items disclosed in the filing: convertible senior notes totaling $749.8 million in principal, a Paragraph IV notice received in February 2016 challenging patents covering ruxolitinib phosphate that expire in 2028 (the composition-of-matter patent expires December 24, 2027, and the notice does not challenge it), and cash, cash equivalents and marketable securities of $629.2 million. Management states that these resources are adequate for at least the next twelve months.

    Aug 9, 2016
  34. 2016-Q1

    Incyte Quarterly Report for Q1 Ended Mar 31, 2016

    Incyte Corporation's first quarter 2016 Form 10-Q reports total revenues of $263.5 million, up from $159.3 million in the prior-year quarter, and net income of $24.0 million, or $0.13 per basic share, compared with a net loss of $18.4 million, or $0.11 per share, a year earlier. Product revenues, net from JAKAFI were $183.3 million, versus $115.3 million, with the filing citing a volume increase of $56.9 million and a price increase of $11.1 million. Contract revenues rose to $58.2 million, driven largely by a $35.0 million regulatory milestone and a $20.0 million regulatory milestone from Eli Lilly tied to baricitinib. Income from operations was $36.0 million, compared with a loss of $6.9 million a year earlier, though research and development expense rose to $156.8 million and selling, general and administrative expense to $64.6 million. The balance sheet shows cash and cash equivalents of $657.6 million and marketable securities of $153.1 million, for total cash, cash equivalents and marketable securities of $810.7 million at March 31, 2016. Total convertible senior notes stand at $749.8 million principal, and the company reports an accumulated deficit of $1.8 billion. The company early adopted ASU No. 2016-09, which resulted in recognition of $325.6 million of deferred tax assets offset by a full valuation allowance. The filing also discloses a Paragraph IV notice regarding a generic version of JAKAFI, with patents expiring in 2028, and describes a May 2016 agreement to acquire the European operations of ARIAD for an upfront payment of $140.0 million, expected to close June 1, 2016.

    May 9, 2016
  35. 2015-Q3

    Incyte Quarterly Report for Q3 Ended Sep 30, 2015

    Incyte Corporation's Form 10-Q for the quarter ended September 30, 2015 shows a net loss of $39.6 million for the three months and $48.6 million for the nine months, compared with net income of $59.3 million and a net loss of $11.5 million in the same periods of 2014. Total revenues were $187.6 million for the quarter and $509.9 million for the nine months. Product revenues, net from JAKAFI rose to $161.3 million for the quarter ($97.8 million a year earlier) and to $419.0 million for the nine months ($251.5 million). Contract revenues fell sharply to $8.2 million for the quarter from $88.2 million, reflecting the lower milestone recognition in the period. Research and development expense rose to $132.1 million for the quarter and $362.9 million for the nine months, including a $25.0 million upfront payment to Hengrui and a $20.2 million charge tied to the Agenus upfront payment. The balance sheet at September 30, 2015 showed cash, cash equivalents and marketable securities of $635.0 million and total stockholders' equity of $88.7 million, up from a deficit of $81.6 million at December 31, 2014. Total convertible senior debt principal was $750.0 million, with the 4.75% notes due 2015 nearly fully converted into common stock. Operating cash flow was positive at $16.5 million for the nine months. The company also recorded an unrealized loss of $31.3 million for the quarter on its long-term investment in Agenus Inc. common stock, which was marked to market under the fair value option. Management states that cash and marketable securities are adequate for at least the next twelve months. The company disclosed a pending purchase of its leased Wilmington headquarters land and office building for approximately $79.9 million, with closing expected no later than April 1, 2016, and a new Hengrui license for an anti-PD-1 antibody with potential milestones of up to $770 million. Generic competition risk for JAKAFI could emerge as early as the fourth quarter of 2015, when the Hatch-Waxman challenge window opens.

    Nov 3, 2015
  36. 2015-Q2

    Incyte Quarterly Report for Q2 Ended Jun 30, 2015

    Incyte Corporation's Form 10-Q for the quarter ended June 30, 2015 reports a return to net income for the second quarter. Net income was $9.3 million, or $0.05 per diluted share, for the three months ended June 30, 2015, versus a net loss of $36.9 million, or $0.22 per share, a year earlier. For the six months, the company reported a net loss of $9.1 million ($0.05 per share), narrowed from $70.8 million ($0.43 per share) in the prior-year period. Total revenues were $163.0 million for the quarter and $322.3 million for the six months, led by JAKAFI product revenues, net of $142.4 million and $257.7 million respectively. The quarterly results also included a $27.2 million unrealized gain on the company's long-term investment in Agenus Inc. The balance sheet shows total assets of $930.3 million and stockholders' equity of $55.2 million at June 30, 2015, compared with a deficit of $81.6 million at December 31, 2014. Cash, cash equivalents and marketable securities totaled $627.5 million. Total debt principal was $793.8 million, including $43.8 million of 4.75% convertible notes due 2015, $375.0 million of 0.375% notes due 2018 and $375.0 million of 1.25% notes due 2020. The filing notes that the 2018 and 2020 notes became convertible on July 1, 2015, though management intends to settle conversions in common shares. Management states that current capital resources are adequate for at least the next twelve months. Operating expenses rose with research and development spending of $112.4 million for the quarter, up from $84.7 million, driven by clinical research costs and a $20.2 million charge tied to the Agenus upfront payment. Selling, general and administrative expenses were $51.7 million for the quarter. The company also disclosed that the Phase II docetaxel combination trial of INCB39110 in NSCLC was stopped in the second quarter of 2015 due to slow recruitment, and that a generic challenge to JAKAFI patents could begin as early as the fourth quarter of 2015.

    Aug 4, 2015
  37. 2015-Q1

    Incyte Quarterly Report for Q1 Ended Mar 31, 2015

    Incyte Corporation's 10-Q for the quarter ended March 31, 2015 reports total revenues of $159.3 million, up from $89.8 million in the prior-year quarter, driven by product revenues of $115.3 million from JAKAFI (up from $69.7 million), product royalty revenues of $15.7 million, and contract revenues of $28.2 million, which include a $25.0 million regulatory milestone from Novartis. Net loss narrowed to $18.4 million ($0.11 per share) from $34.0 million ($0.21 per share) a year earlier, though research and development expense rose to $118.4 million, including a $20.2 million charge for the upfront payment to Agenus. Net cash used in operating activities was $4.6 million, versus $31.7 million in the prior-year period. The balance sheet shows cash, cash equivalents and marketable securities of $585.4 million at March 31, 2015, against a stockholders' deficit of $41.4 million and total debt principal of $840.8 million across three convertible senior note series. The 2018 and 2020 Notes became convertible through at least June 30, 2015, and management intends to settle any conversions in common shares. In April 2015, holders converted $46.9 million of the 2015 Notes into about 5.3 million shares. During the quarter the company entered a licensing agreement with Agenus Inc. covering four checkpoint modulator programs and bought a 7.76 million share stake in Agenus for $39.8 million, which is carried as a long-term investment at fair value. The filing also notes that JAKAFI's ability to face generic challenges begins as early as the fourth quarter of 2015, and that the company has accumulated a deficit of $1.8 billion.

    Apr 30, 2015
  38. 2014-Q3

    Incyte Quarterly Report for Q3 Ended Sep 30, 2014

    Incyte Corporation's Form 10-Q for the quarter ended September 30, 2014 reports a return to net income for the third quarter, driven largely by contract revenues. For the three months ended September 30, 2014, total revenues were $198.1 million, up from $85.1 million, and the company recorded net income of $59.3 million, or $0.35 basic and $0.33 diluted per share, compared with a net loss of $22.0 million in the prior-year period. Contract revenues rose to $88.2 million from $16.7 million, and product revenues, net, from JAKAFI increased to $97.8 million from $60.2 million. For the nine months, Incyte reported a net loss of $11.5 million, narrower than the $40.3 million loss a year earlier, with total revenues of $387.5 million. The balance sheet shows cash, cash equivalents and marketable securities of $532.4 million at September 30, 2014, and a stockholders' deficit of $89.6 million. Total debt principal was $841.4 million, comprising the 4.75% convertible senior notes due 2015, 0.375% notes due 2018 and 1.25% notes due 2020. Net cash used in operating activities was $18.5 million for the nine months, compared with cash provided of $20.9 million a year earlier. Stock-based compensation rose to $46.3 million for the nine months from $28.6 million. Management highlighted pending regulatory and development milestones, including a PDUFA date of December 5, 2014 for the supplemental New Drug Application for ruxolitinib in polycythemia vera. The filing also disclosed that the RELIEF trial in PV did not meet its primary endpoint, and that INCB47986 was terminated after preclinical toxicological findings. The new Wilmington, Delaware headquarters lease commenced on October 1, 2014.

    Oct 30, 2014
  39. 2014-Q2

    Incyte Quarterly Report for Q2 Ended Jun 30, 2014

    Incyte Corporation's Form 10-Q for the quarter ended June 30, 2014 shows a widening net loss as operating spending rose faster than revenue. Total revenues were $99.6 million for the three months ended June 30, 2014, versus $101.7 million a year earlier, while the net loss grew to $36.9 million ($0.22 per share) from $2.6 million ($0.02 per share). For the six months, net loss was $70.8 million ($0.43 per share) compared with $18.2 million ($0.13 per share). Research and development expense rose to $84.7 million in the quarter from $60.9 million, and selling, general and administrative expense rose to $40.9 million from $23.2 million, reflecting pipeline development and JAKAFI commercialization efforts. Product revenues from JAKAFI were $84.0 million for the quarter, up from $54.1 million, and product royalty revenues from Novartis's JAKAVI sales were $12.3 million, up from $5.8 million. Contract revenues fell to $3.2 million from $41.7 million because the Novartis upfront payment was fully amortized at December 31, 2013. Cash, cash equivalents and marketable securities totaled $508.8 million at June 30, 2014, against $841.6 million of principal on convertible senior debt and an accumulated deficit of $1.8 billion. Net cash used in operating activities was $46.3 million for the six months. The filing also notes that the RELIEF trial in polycythemia vera missed its primary endpoint, and that a $25.0 million Novartis milestone was earned in July 2014 for JAKAVI's approval in Japan. Management states that existing cash, cash equivalents and marketable securities are adequate for at least the next twelve months, but it expects to need additional financing in the longer term through equity, debt or collaborations. The filing also discloses a stockholders' deficit of $171.0 million and the lease obligations for a new Wilmington, Delaware headquarters.

    Jul 31, 2014
  40. 2014-Q1

    Incyte Quarterly Report for Q1 Ended Mar 31, 2014

    Incyte Corporation's quarterly report for the period ended March 31, 2014 shows total revenues of $89.8 million, up from $71.1 million in the prior-year quarter, driven primarily by product revenues of JAKAFI of $69.7 million versus $48.3 million. Product royalty revenues were $9.8 million compared with $5.9 million, while contract revenues declined to $10.2 million from $16.7 million, reflected as the Novartis upfront fee being fully amortized at December 31, 2013. Total costs and expenses rose to $112.7 million from $75.2 million, led by research and development of $75.6 million (up from $52.8 million) and selling, general and administrative expenses of $37.0 million (up from $22.3 million). The company reported a net loss of $34.0 million, or $0.21 per share, compared with a net loss of $15.7 million, or $0.12 per share, in the prior-year period. The balance sheet shows cash, cash equivalents and marketable securities of $519.2 million at March 31, 2014, against total debt principal of $841.6 million across three convertible senior notes. The company's stockholders' deficit was $162.4 million, and its accumulated deficit reached $1.8 billion. Net cash used in operating activities was $31.7 million for the quarter, compared with $24.7 million provided in the prior-year period. Management states that cash and marketable securities are adequate for at least the next twelve months, and the filing notes that the company expects to need additional capital in the future. On the regulatory and pipeline front, the filing reports positive top-line results from the registration trial of ruxolitinib in polycythemia vera, with a supplemental New Drug Application expected in the first half of 2014. A Phase III registration program in advanced or metastatic pancreatic cancer began in March 2014 under a special protocol assessment. A securities class action was dismissed with prejudice on March 31, 2014.

    May 1, 2014
  41. 2013-Q3

    Incyte Quarterly Report for Q3 Ended Sep 30, 2013

    Incyte Corporation's Form 10-Q for the quarter ended September 30, 2013 reports total revenues of $85.1 million for the three months and $257.9 million for the nine months, up from $60.5 million and $183.2 million a year earlier. Product revenues, net from JAKAFI were $60.2 million for the quarter and $162.6 million for the nine months, compared with $43.7 million and $92.7 million in the prior-year periods. Product royalty revenues from Novartis's sales of JAKAVI were $8.2 million for the quarter and $19.9 million for the nine months. Contract revenues were $16.7 million for the quarter and $75.2 million for the nine months, the latter including a $25.0 million Novartis milestone for INCB28060. The company reported a net loss of $22.0 million, or $0.14 per share, for the quarter, versus $21.7 million, or $0.17 per share, a year earlier. For the nine months, the net loss was $40.3 million, or $0.28 per share, compared with $63.1 million, or $0.49 per share. Income from operations for the nine months was $39 thousand, compared with a loss from operations of $29.1 million in the prior-year period. Debt exchange expense of $11.3 million for the nine months relates to exchanges of $181.0 million of 4.75% convertible senior notes for common stock and cash. Stockholders' equity moved to $28.8 million at September 30, 2013 from a deficit of $175.0 million at December 31, 2012, and cash, cash equivalents and marketable securities totaled $291.2 million. The filing also discloses two securities class action lawsuits filed in March and April 2013 in the U.S. District Court for the District of Delaware, which the company says it intends to vigorously defend. In October 2013 a lease for a new 190,000 square foot facility in Wilmington, Delaware became effective, with future minimum lease payments of approximately $80.0 million over 15 years.

    Oct 31, 2013
  42. 2013-Q2

    Incyte Quarterly Report for Q2 Ended Jun 30, 2013

    Incyte Corporation's Form 10-Q for the quarter ended June 30, 2013 reports total revenues of $101.7 million for the three months ended June 30, 2013, up from $86.5 million a year earlier, and $172.8 million for the six months, compared with $122.7 million. Product revenues, net from JAKAFI were $54.1 million for the quarter and $102.4 million for the six months. Contract revenues were $41.7 million for the quarter, including a $25.0 million milestone payment from Novartis for INCB28060. The company reported a net loss of $2.6 million, or $0.02 per share, for the quarter, compared with net income of $4.0 million in the prior-year quarter, and a net loss of $18.2 million, or $0.13 per share, for the six months. The quarter included $9.8 million of debt exchange expense tied to the exchange of $143.7 million of 4.75% convertible senior notes due 2015 for common stock and cash. The balance sheet shows cash, cash equivalents, a certificate of deposit and marketable securities of $277.5 million at June 30, 2013, and a stockholders' deficit of $27.8 million, improved from $175.0 million at December 31, 2012. Total debt principal was $266.3 million. Operating cash flow was positive at $32.8 million for the six months, versus a $45.7 million use in the prior-year period. The company states that its cash is adequate for at least the next twelve months, while noting it expects to rely on future equity, debt or collaboration financing until product revenues are sufficient. Investors should note two pending securities class actions filed in March and April 2013 in the U.S. District Court for the District of Delaware, which allege misleading statements about the commercial launch of JAKAFI. The company is unable to estimate a possible loss. The filing also notes a contingent 15-year lease for approximately 190,000 square feet in Wilmington, Delaware, and a Delaware state grant of up to approximately $11.0 million.

    Aug 1, 2013
  43. 2013-Q1

    Incyte Quarterly Report for Q1 Ended Mar 31, 2013

    Incyte Corporation's first-quarter 2013 Form 10-Q reports total revenues of $71.1 million for the three months ended March 31, 2013, up from $36.2 million a year earlier, driven by product revenues of JAKAFI (ruxolitinib) of $48.3 million versus $19.3 million, plus product royalty revenues of $5.9 million from Novartis. Net loss narrowed to $15.7 million, or $0.12 per share, compared with a net loss of $45.4 million, or $0.36 per share, in the prior-year quarter. Operating expenses rose, with research and development at $52.8 million and selling, general and administrative expenses at $22.3 million, and interest expense was $11.7 million. At March 31, 2013, cash, cash equivalents and marketable securities totaled $270.2 million, against total debt of $410.0 million and a stockholders' deficit of $163.5 million. Operating cash flow was positive at $24.7 million, compared with a $54.4 million use in the prior-year period, largely due to lower net loss and changes in accounts receivable. The company states it believes existing cash will be adequate for at least the next twelve months, but notes it may need to raise additional capital. The filing also discloses two securities class action lawsuits filed in March and April 2013 in the U.S. District Court for the District of Delaware, relating to statements about the commercial launch of JAKAFI, and a contingent new 15-year Wilmington, Delaware lease for about 190,000 square feet, plus a $25.0 million milestone earned from Novartis in April 2013.

    May 2, 2013
  44. 2012-Q3

    Incyte Quarterly Report for Q3 Ended Sep 30, 2012

    Incyte Corporation's Form 10-Q for the quarter ended September 30, 2012 shows total revenues of $60.5 million for the three months ended September 30, 2012, up from $16.8 million a year earlier, driven by the start of JAKAFI product revenues. Product revenues, net were $43.7 million for the quarter and $92.7 million for the nine months. Contract revenues were $16.7 million for the quarter and $90.2 million for the nine months, including a $40.0 million milestone from Novartis tied to the CHMP recommendation for JAKAVI in the European Union. The company reported a net loss of $21.7 million, or $0.17 per share, for the quarter, compared with $53.1 million, or $0.42 per share, a year earlier. For the nine months, the net loss was $63.1 million, or $0.49 per share, versus $131.5 million, or $1.05 per share. The company reported an accumulated deficit of $1.7 billion and a stockholders' deficit of $219.95 million at September 30, 2012. The filing states that the company changed its revenue recognition for JAKAFI in the quarter, moving from the sell-through method to the sell-in method after gaining sufficient experience with product returns. As a result, the quarter included $9.0 million of revenue deferred from prior periods, which provided a benefit of $0.07 per share. Cash and cash equivalents were $239.1 million at quarter end, and available cash, cash equivalents and marketable securities totaled $243.6 million, excluding a $9.5 million escrow account reserved for interest payments on the 4.75% convertible senior notes due 2015. Net cash used in operating activities narrowed to $72.8 million for the nine months from $121.9 million, mainly due to the lower net loss and the $40.0 million Novartis milestone. Total debt principal was $420.0 million, including $400.0 million of 4.75% convertible senior notes due 2015 and $20.0 million of Pfizer convertible subordinated notes. The company states that its cash and marketable securities will be adequate to meet capital needs for at least the next twelve months, but it expects to need additional financing over time. The filing identifies reliance on JAKAFI sales, a limited number of specialty pharmacies, and third-party manufacturers as key risks.

    Nov 1, 2012
  45. 2012-Q2

    Incyte Quarterly Report for Q2 Ended Jun 30, 2012

    Incyte Corporation's Form 10-Q for the quarter ended June 30, 2012 shows total revenues of $86.5 million for the three months ended June 30, 2012, up from $16.8 million a year earlier, with the company reporting net income of $4.0 million, or $0.03 per diluted share, versus a net loss of $51.9 million in the prior-year quarter. The results were driven by $29.7 million in JAKAFI product revenues, net, following FDA approval for intermediate or high-risk myelofibrosis in November 2011, and $56.7 million in contract revenues, which included a $40.0 million regulatory milestone from Novartis tied to a CHMP recommendation for ruxolitinib approval in the European Union. For the six months ended June 30, 2012, the company reported a net loss of $41.4 million, or $0.32 per share, compared with $78.4 million, or $0.63 per share, a year earlier. The balance sheet remains strained. As of June 30, 2012, the company reported a total stockholders' deficit of $217.2 million, an accumulated deficit of $1.7 billion, and total debt principal of $420.0 million, including $400.0 million of 4.75% convertible senior notes due 2015. Cash, cash equivalents and marketable securities totaled $261.8 million, excluding a $9.5 million restricted escrow account reserved for interest payments on the senior notes through October 2012. Net cash used in operating activities narrowed to $45.7 million for the six months ended June 30, 2012, from $75.0 million a year earlier, which the company attributed mainly to the Novartis milestone and JAKAFI net product revenues. The filing also highlights ongoing concentration and execution risks. One customer accounted for 62% of total revenues in the second quarter of 2012, and three customers comprised 66% of accounts receivable at June 30, 2012. The company relies on single-source suppliers for certain components and has no manufacturing facilities for commercial production. Management stated that cash and marketable securities should be adequate for at least the next twelve months, but noted that it may need additional capital and that it has not yet achieved sustained revenues sufficient to offset expenses.

    Aug 3, 2012
  46. 2012-Q1

    Incyte Quarterly Report for Q1 Ended Mar 31, 2012

    Incyte Corporation's Form 10-Q for the quarter ended March 31, 2012 reports total revenues of $36.2 million, up from $32.0 million in the prior-year quarter, driven by first product revenues of $19.3 million net from JAKAFI (ruxolitinib), which received FDA approval for intermediate or high-risk myelofibrosis in November 2011. Contract revenues fell to $16.7 million from $31.8 million, as the prior-year period included a $15.0 million Novartis milestone. The company's net loss widened to $45.4 million, or $0.36 per share, from $26.5 million, or $0.21 per share, as research and development expense rose to $49.0 million and selling, general and administrative expense rose to $21.4 million, reflecting commercialization and pipeline spending. The balance sheet shows cash, cash equivalents and marketable securities of $236.4 million, excluding a $19.0 million restricted escrow account reserved for interest payments on the 4.75% convertible senior notes due 2015. Cash used in operating activities was $54.4 million for the quarter. Total liabilities were $542.5 million against total assets of $293.6 million, leaving a stockholders' deficit of $248.9 million, and the accumulated deficit reached $1.7 billion. Total debt principal was $420.0 million as of March 31, 2012. The filing also notes a subsequent event: Incyte expects to receive a $40.0 million milestone payment from Novartis in the quarter ending June 30, 2012, tied to an April 2012 recommendation by the European Medicines Agency's CHMP for approval of ruxolitinib. Management believes current cash, cash equivalents and marketable securities will be adequate to meet capital needs for at least the next twelve months, but the company states it expects to need additional capital and may never achieve sustained profitability.

    Apr 26, 2012
  47. 2011-Q3

    Incyte Quarterly Report for Q3 Ended Sep 30, 2011

    Incyte Corporation's Form 10-Q for the quarter ended September 30, 2011 reports a net loss of $53.1 million, or $0.42 per share, for the three months ended September 30, 2011, compared with a net loss of $31.7 million, or $0.26 per share, a year earlier. For the nine months, the net loss was $131.5 million, or $1.05 per share, versus $64.4 million, or $0.53 per share, in 2010. Total revenues were $16.8 million for the quarter and $65.6 million for the nine months, versus $84.0 million in the prior-year nine-month period, which included $30.0 million and $3.0 million of milestone payments under the Lilly and Pfizer agreements. Research and development expense rose to $44.6 million for the quarter and $126.8 million for the nine months, while selling, general and administrative expense rose to $14.3 million and $37.1 million, driven by preparation for a potential commercial launch of ruxolitinib. The company's cash, cash equivalents and marketable securities totaled $317.0 million at September 30, 2011, excluding a $28.5 million escrow account reserved for interest payments through October 2012 on its 4.75% convertible senior notes due 2015. Net cash used in operating activities was $121.9 million for the nine months. Total liabilities exceeded total assets, leaving a stockholders' deficit of $181.0 million, and the company reported an accumulated deficit of $1.6 billion. Management states that cash and marketable securities should be adequate for at least the next twelve months. The most significant pending development is ruxolitinib for myelofibrosis. The company submitted a New Drug Application in June 2011, the FDA accepted it in August 2011 and granted priority review, and the company stated that the drug could be available to U.S. patients as early as the fourth quarter of 2011 if approved. The company also discontinued development of INCB7839 for metastatic breast cancer in September 2011.

    Oct 27, 2011
  48. 2011-Q2

    Incyte Quarterly Report for Q2 Ended Jun 30, 2011

    Incyte Corporation's Form 10-Q for the quarter ended June 30, 2011 reports a net loss of $51.9 million, or $0.41 per share, for the three months ended June 30, 2011, compared with net income of $3.0 million, or $0.02 per diluted share, in the same period of 2010. For the six months ended June 30, 2011, the net loss was $78.4 million, or $0.63 per share, versus $32.7 million, or $0.27 per share, a year earlier. Total revenues fell to $16.8 million for the quarter from $49.8 million, reflecting lower contract revenues after milestone payments recognized in 2010 under the Lilly and Pfizer agreements. Research and development expenses rose to $46.0 million for the quarter from $28.9 million, driven by higher clinical research costs and headcount, while selling, general and administrative expenses rose to $11.9 million from $7.5 million as the company prepared for potential commercialization of ruxolitinib. The company's balance sheet shows cash, cash equivalents and marketable securities of $364.1 million at June 30, 2011, excluding a $28.5 million restricted escrow account for interest payments on its 4.75% convertible senior notes due 2015. Net cash used in operating activities was $75.0 million for the six months, compared with $100.1 million provided in the prior-year period, which had benefited from collaborator upfront and milestone payments. Total stockholders' deficit was $136.3 million, and the accumulated deficit reached $1.5 billion. Management states that existing cash and marketable securities will be adequate to meet capital needs for at least the next twelve months. The filing highlights the company's lead candidate, ruxolitinib, for which a New Drug Application for myelofibrosis was submitted in June 2011, with the company stating it expects fast track status could support priority review and a potential commercialization launch in late 2011 if approved within that timeline. The filing also notes that ruxolitinib is licensed to Novartis outside the United States, and that LY3009104 is being co-developed with Eli Lilly for rheumatoid arthritis.

    Jul 28, 2011
  49. 2011-Q1

    Incyte Quarterly Report for Q1 Ended Mar 31, 2011

    Incyte Corporation's Form 10-Q for the quarter ended March 31, 2011 reports a net loss of $26.5 million, or $0.21 per basic and diluted share, compared with a net loss of $35.7 million, or $0.30 per share, in the first quarter of 2010. Total revenues were $32.0 million, up from $17.3 million, and contract revenues included a $15.0 million milestone for INCB28060 recognized under the Novartis agreement. Research and development expenses rose to $36.3 million from $31.4 million, and selling, general and administrative expenses rose to $10.8 million from $5.8 million, which the filing attributes to preparation for the potential commercialization of ruxolitinib for myelofibrosis. The balance sheet shows cash and cash equivalents of $377.8 million at March 31, 2011, with cash, cash equivalents and marketable securities totaling $383.6 million excluding a $37.9 million restricted cash escrow for interest on the 4.75% convertible senior notes due 2015. Total stockholders' deficit widened to $104.0 million, and the accumulated deficit reached $1.4 billion. Net cash used in operating activities was $44.2 million, compared with $102.8 million provided in the prior-year period, a shift the filing attributes mainly to upfront and milestone payments received from collaborators in the first quarter of 2010. The company states that its cash and marketable securities should be adequate for at least the next twelve months. The filing states that Incyte intends to submit a New Drug Application for ruxolitinib for myelofibrosis in the second quarter of 2011, that the drug has fast track designation, and that it plans to begin commercialization in late 2011 if approval comes within the expected priority review timeline. The Genomic Health litigation was resolved on April 29, 2011, on terms the company describes as not material to its financial statements.

    May 3, 2011
  50. 2010-Q3

    Incyte Quarterly Report for Q3 Ended Sep 30, 2010

    Incyte Corporation's Form 10-Q for the quarter ended September 30, 2010 shows a company still reporting net losses while it leans on collaboration revenue. For the nine months ended September 30, 2010, total revenues were $84.0 million (versus $2.4 million in the 2009 period), driven by contract revenues of $83.2 million tied to the Novartis and Lilly agreements and milestone payments. Net loss was $64.4 million, or $0.53 per share, compared with a net loss of $123.4 million, or $1.26 per share, in the prior-year nine months. Research and development expenses were $91.1 million and SG&A was $21.6 million for the nine months. The balance sheet remains stretched. Total stockholders' deficit was $128.9 million at September 30, 2010, with total liabilities of $593.5 million against total assets of $464.6 million. Cash, cash equivalents and marketable securities totaled $395.6 million, excluding a $47.4 million restricted escrow account reserved for interest payments through October 2012 on the 4.75% convertible senior notes due 2015. Accumulated deficit reached $1.5 billion. Operating cash flow turned positive at $70.5 million for the nine months, versus a $106.2 million outflow a year earlier, mainly due to upfront and milestone receipts from collaborators. During the period the company redeemed its remaining 3½% convertible senior notes and subordinated notes for $158.6 million in cash. Management expects losses to continue for several years, and states that cash and marketable securities will be adequate for at least the next twelve months. Subsequent to quarter-end, Incyte reported earning a $19.0 million milestone from Lilly and $50.0 million in milestones from Novartis, expected to be received in the quarter ending December 31, 2010. The filing also discloses a Genomic Health lawsuit seeking approximately $3.6 million, which management does not expect to be material.

    Nov 9, 2010