Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 or o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-12400 INCYTE CORPORATION (Exact name of registrant as specified in its charter) (State or other jurisdict ...

Incyte Corporation (NASDAQ:INCY) Q2 2022 Earnings Conference Call August 2, 2022 8:00 AM ET Company Participants Christine Chiou – Head of Investor Relations Hervé Hoppenot – Chairman, President and Chief Executive Officer Barry Flannelly – Executive Vice President and General Manager-North America Steven Stein – Executive Vice President and Chief Medical Officer Christiana Stamoulis – Executive Vice President and Chief Financial Officer Dash Dhanak – Executive Vice President and Chief Scientific Officer Co ...

Financial Performance - Total revenues increased by 29% year-over-year, reaching $911 million in Q2 2022, compared to $706 million in Q2 2021[5, 6] - Net product revenues grew by 15% year-over-year, amounting to $664 million in Q2 2022, up from $575 million in Q2 2021[5, 46] - Jakafi net sales reached $598 million in Q2 2022, a 13% increase year-over-year[6, 19] - Milestone and contract revenue saw a significant increase, reaching $130 million in Q2 2022, compared to $10 million in Q2 2021, representing a 1,200% growth[6, 46] - For the first half of 2022, total revenues were $1645 million, a 26% increase compared to $1310 million in the first half of 2021[46] Product Updates and Approvals - Opzelura, a new product, contributed $17 million in revenue in Q2 2022[6] - Multiple approvals for Jakavi, Olumiant and Tabrecta in Q2, including approval as the first post-steroid systemic treatment for acute and chronic graft-versus-host disease (GVHD) in Europe and as the first and only systemic treatment for alopecia areata in the U S, Europe and Japan[9] - Opzelura approved with broad label in nonsegmental vitiligo for 12 years of age and older, apply to affected areas of up to 10% BSA, approved for continuous use anywhere on body, no limits on duration of use[8, 15] Pipeline and Clinical Development - The company is progressing with its pipeline, with Povorcitinib (INCB54707) Phase 3 in HS in preparation and CK08041 + ruxolitinib IND clearance to initiate P1b in MF[11] - Ruxolitinib cream maintenance study ongoing; ruxolitinib cream + phototherapy study ongoing[22] Opzelura Market Performance - Covered claims for Opzelura reached 54% by the end of Q2 2022[13] - High satisfaction with Opzelura expected to drive uptake, HCPs that are highly satisfied with Opzelura has increased from 46% to 67%[12] - Proportion of treated patients considered candidates for Opzelura has increased from 37% to 47%[12]

[PART I: FINANCIAL INFORMATION](index=4&type=section&id=PART%20I%3A%20FINANCIAL%20INFORMATION) [Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) This section presents Incyte Corporation's unaudited condensed consolidated financial statements for Q2 and H1 2022, including balance sheets, statements of operations, comprehensive income, stockholders' equity, and cash flows [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets increased to **$5.32 billion** by June 30, 2022, driven by cash growth, with total liabilities at **$1.23 billion** and equity at **$4.09 billion** Condensed Consolidated Balance Sheet Highlights (in millions USD) | Account | June 30, 2022 (in millions USD) | December 31, 2021 (in millions USD) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $2,435.4 | $2,057.4 | | Total current assets | $3,625.8 | $3,118.7 | | Total assets | $5,319.0 | $4,933.4 | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $926.7 | $854.3 | | Total liabilities | $1,234.0 | $1,163.3 | | Total stockholders' equity | $4,085.1 | $3,770.0 | [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Total revenues for Q2 2022 increased **29%** to **$911.4 million**, resulting in net income of **$161.4 million** or **$0.72** per diluted share Q2 2022 vs Q2 2021 Statement of Operations (in millions USD, except per share data) | Metric | Q2 2022 (in millions USD) | Q2 2021 (in millions USD) | | :--- | :--- | :--- | | Total revenues | $911.4 | $705.7 | | Income from operations | $254.4 | $140.8 | | Net income | $161.4 | $149.5 | | Diluted net income per share | $0.72 | $0.67 | Six Months 2022 vs 2021 Statement of Operations (in millions USD, except per share data) | Metric | H1 2022 (in millions USD) | H1 2021 (in millions USD) | | :--- | :--- | :--- | | Total revenues | $1,644.6 | $1,310.4 | | Income from operations | $371.0 | $239.6 | | Net income | $199.4 | $203.0 | | Diluted net income per share | $0.89 | $0.91 | [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash from operating activities for H1 2022 was **$389.9 million**, with investing activities using **$29.2 million**, primarily due to lower capital expenditures Cash Flow Summary for Six Months Ended June 30 (in millions USD) | Activity | 2022 (in millions USD) | 2021 (in millions USD) | | :--- | :--- | :--- | | Net cash provided by operating activities | $389.9 | $379.0 | | Net cash used in investing activities | ($29.2) | ($108.9) | | Net cash provided by financing activities | $16.0 | $16.5 | | **Net increase in cash** | **$377.9** | **$284.5** | [Notes to Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail accounting policies, revenue recognition, fair value, credit risk, inventory, and collaboration agreements, with Novartis and Lilly driving royalty and milestone revenue Disaggregated Revenue for Six Months Ended June 30 (in millions USD) | Revenue Source | H1 2022 (in millions USD) | H1 2021 (in millions USD) | | :--- | :--- | :--- | | JAKAFI revenues, net | $1,142.1 | $994.8 | | OPZELURA revenues, net | $29.3 | $0 | | Total product revenues, net | $1,269.7 | $1,080.0 | | Total product royalty revenues | $240.0 | $220.5 | | Milestone and contract revenues | $135.0 | $10.0 | | **Total revenues** | **$1,644.6** | **$1,310.4** | - In Q2 2022, the company recognized significant milestone revenues: **$60.0 million** from Novartis (related to capmatinib and JAKAVI approvals in Europe) and **$70.0 million** from Lilly (related to OLUMIANT approval for alopecia areata)[44](index=44&type=chunk)[46](index=46&type=chunk)[51](index=51&type=chunk) - Total inventory increased to **$94.1 million** as of June 30, 2022, from **$56.9 million** at year-end 2021, with approximately **$66.0 million** of pre-FDA approval inventory expected to lower future cost of product revenues[40](index=40&type=chunk)[41](index=41&type=chunk) - The company's collaboration with MorphoSys for tafasitamab resulted in a collaboration loss sharing of **$7.3 million** for H1 2022, a decrease from **$20.3 million** in H1 2021, with R&D expenses for the collaboration at **$48.5 million** in H1 2022[87](index=87&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=28&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Q2 2022 financial results, highlighting a **29%** revenue increase driven by JAKAFI and **$130.0 million** in milestone revenues, while SG&A expenses increased **50%** due to OPZELURA launch activities [Overview](index=33&type=section&id=Overview) Incyte operates in Hematology/Oncology and Inflammation & Autoimmunity, with key products like JAKAFI and OPZELURA, and is advancing a broad clinical pipeline including the LIMBER program - JAKAFI (ruxolitinib) is approved in the U.S. for myelofibrosis (MF), polycythemia vera (PV), and both acute and chronic graft-versus-host disease (GVHD)[143](index=143&type=chunk) - OPZELURA (ruxolitinib) cream was approved by the FDA in July 2022 for nonsegmental vitiligo, making it the first and only FDA-approved treatment for repigmentation in this condition, following its initial approval for atopic dermatitis in September 2021[213](index=213&type=chunk)[214](index=214&type=chunk) - The LIMBER clinical development program is evaluating combinations of ruxolitinib with other agents like parsaclisib (PI3Kδ) and INCB57643 (BET) to expand treatment options for myeloproliferative neoplasms[181](index=181&type=chunk)[182](index=182&type=chunk)[183](index=183&type=chunk) - In January 2022, the company withdrew the New Drug Application (NDA) for parsaclisib in non-Hodgkin lymphomas due to the infeasibility of completing required confirmatory studies in a timely manner[197](index=197&type=chunk) [Results of Operations](index=50&type=section&id=Results%20of%20Operations) Q2 2022 total revenues grew **29%** to **$911.4 million**, driven by JAKAFI and **$130.0 million** in milestone revenues, while SG&A expenses increased **50%** due to OPZELURA launch activities Revenue Breakdown (in millions USD) | Revenue Source | Q2 2022 (in millions USD) | Q2 2021 (in millions USD) | | :--- | :--- | :--- | | JAKAFI revenues, net | $597.7 | $529.1 | | OPZELURA revenues, net | $16.6 | $0 | | Total product revenues, net | $663.9 | $575.2 | | Total product royalty revenues | $117.5 | $120.5 | | Milestone and contract revenues | $130.0 | $10.0 | | **Total revenues** | **$911.4** | **$705.7** | Operating Expenses (in millions USD) | Expense Category | Q2 2022 (in millions USD) | Q2 2021 (in millions USD) | | :--- | :--- | :--- | | Cost of product revenues | $50.6 | $38.0 | | Research and development | $347.2 | $343.5 | | Selling, general and administrative | $253.3 | $168.9 | - The increase in SG&A expenses was primarily driven by costs related to establishing the dermatology commercial organization and activities supporting the launch of OPZELURA for atopic dermatitis and pre-launch activities for vitiligo[295](index=295&type=chunk) - The company recorded an unrealized loss of **$24.9 million** on long-term investments in Q2 2022, compared to a gain of **$26.8 million** in Q2 2021, due to market value changes in its holdings of publicly traded collaboration partners[300](index=300&type=chunk) [Liquidity and Capital Resources](index=54&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2022, Incyte held **$2.7 billion** in cash and marketable securities, with **$389.9 million** in H1 2022 operating cash flow, sufficient for future needs despite increased R&D tax capitalization - The company holds **$2.7 billion** in cash, cash equivalents, and marketable securities as of June 30, 2022[301](index=301&type=chunk) - In August 2021, the company entered into a **$500.0 million**, three-year senior unsecured revolving credit facility, which was undrawn as of June 30, 2022[308](index=308&type=chunk) - U.S. income tax payments are expected to increase significantly due to the mandatory capitalization and amortization of R&D expenses for tax purposes, as required by the Tax Cuts and Jobs Act of 2017, effective for tax years after December 31, 2021[309](index=309&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=55&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company's primary market risk stems from marketable securities, mainly U.S. government debt, subject to interest rate risk, though a **10%** rate increase is not expected to materially impact fair value - The company's marketable securities, valued at **$287.0 million** as of June 30, 2022, are primarily composed of U.S. government debt securities and are subject to interest rate risk[312](index=312&type=chunk) [Controls and Procedures](index=56&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2022, with no material changes to internal control over financial reporting during the quarter - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of June 30, 2022[315](index=315&type=chunk) - No material changes were made to the internal control over financial reporting during the second quarter of 2022[316](index=316&type=chunk) [PART II: OTHER INFORMATION](index=56&type=section&id=PART%20II%3A%20OTHER%20INFORMATION) [Risk Factors](index=56&type=section&id=Item%201A.%20Risk%20Factors) This section details key risks including heavy dependence on JAKAFI, reimbursement challenges, competition, public health crises, clinical development failures, regulatory hurdles, and intellectual property threats - **Commercial Risk:** The company is heavily dependent on its lead product, JAKAFI, where any revenue decrease could materially harm the business, with success contingent on patient/physician acceptance, reimbursement, and fending off generic competition[317](index=317&type=chunk)[318](index=318&type=chunk) - **Reimbursement Risk:** Successful product commercialization depends on obtaining and maintaining adequate coverage and reimbursement from government and private payors, who are increasingly challenging prices and implementing cost-control measures[323](index=323&type=chunk)[324](index=324&type=chunk) - **Development Risk:** The company may be unsuccessful in discovering and developing new drug candidates, as clinical development is a long, expensive, and uncertain process with a high rate of failure even in late-stage trials[365](index=365&type=chunk)[370](index=370&type=chunk) - **Regulatory Risk:** The FDA and other global regulatory agencies impose rigorous and extensive regulations, with non-compliance potentially leading to loss of approval, fines, or other penalties, and recent FDA labeling updates for JAK inhibitors like JAKAFI and OPZELURA could negatively affect future sales[338](index=338&type=chunk)[339](index=339&type=chunk) - **Intellectual Property Risk:** The company's success depends on protecting its proprietary technology, as patents may be challenged, invalidated, or circumvented by competitors, with a generic drug company already challenging certain JAKAFI-related patents[451](index=451&type=chunk)[454](index=454&type=chunk) [Exhibits](index=85&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including an amendment to the MacroGenics collaboration agreement and CEO/CFO certifications - Key exhibits filed include CEO/CFO certifications (31.1, 31.2, 32.1, 32.2) and an amendment to the Global Collaboration and License Agreement with MacroGenics, Inc[472](index=472&type=chunk) [Signatures](index=86&type=section&id=Signatures) The report is duly signed and authorized by the company's Chairman, President, and CEO Hervé Hoppenot, and CFO Christiana Stamoulis, on August 2, 2022

1 S286 Presented at the European Hematology Association (EHA) 2022 Hybrid Congress 9–17 June, 2022; Vienna, Austria (& Virtual) | --- | --- | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------| | | | | Long-Term Efficacy and Safety Results From an Ongoing | | | Open-Label Phase 2 Study of Parsaclisib for the | | | Treatment of Autoimmune Hem ...

Incyte 2022 First Quarter Financial and Corporate Update MAY 3, 2022 ■ 官网 | 【国 . - - - - - - - - 000 0000000 Forward-Looking Statements 2 Except for the historical information set forth herein, the matters set forth in this presentation contain predictions, estimates and other forward-looking statements, including statements regarding: the opportunities for growth and diversification presented by Incyte's portfolio; our and our collaborators' potential for receiving regulatory approvals within the next 1-2 ...

Incyte Corporation (NASDAQ:INCY) Q1 2022 Earnings Conference Call May 3, 2022 8:00 AM ET Company Participants Christine Chiou – Head-Investor Relations Hervé Hoppenot – Chairman, President and Chief Executive Officer Barry Flannelly – Executive Vice President and General Manager-North America Steven Stein – Executive Vice President and Chief Medical Officer Christiana Stamoulis – Executive Vice President and Chief Financial Officer Conference Call Participants Vikram Purohit – Morgan Stanley Kripa Devarakon ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-12400 INCYTE CORPORATION (Exact name of registrant as specified in its charter) Delaware 94-3136539 (State or ...

Incyte Corporation (NASDAQ:INCY) Q4 2021 Earnings Conference Call February 8, 2022 8:00 AM ET Company Participants Christine Chiou – Head-Investor Relations Hervé Hoppenot – Chairman, President and Chief Executive Officer Barry Flannelly – Executive Vice President and General Manager-North America Steven Stein – Executive Vice President and Chief Medical Officer Christiana Stamoulis – Executive Vice President and Chief Financial Officer Conference Call Participants Vikram Purohit – Morgan Stanley Brian Abra ...

Large accelerated filer ☒ Accelerated filer ☐ Non-accelerated filer ☐ Smaller reporting company ☐ Emerging growth company ☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐ Indicate by check mark whether the registrant has filed a report on and attestation to its management's assessment of the effectiveness ...