Incyte Corp (INCY) 10-K Annual Report Tue Feb 08 2022

Jakafi^® (ruxolitinib) net product revenues of $592 million (+15%) in Q4’21 and $2.135 billion (+10%) in FY’21; Jakafi guidance range of $2.3 to $2.4 billion for 2022

Successful U.S. launch of Opzelura^TM (ruxolitinib) cream in atopic dermatitis with nearly 19,000 patients treated from launch (October 11^th) through the end of the year

Vitiligo is the next substantial growth opportunity for ruxolitinib cream – under Priority Review in the U.S. and under review in Europe

Conference Call and Webcast Scheduled Today at 8:00 a.m. EDT

WILMINGTON, Del. – February 8, 2022

– Incyte (Nasdaq:INCY) today reports 2021 fourth quarter financial results, provides 2022 financial guidance and a status update on the Company’s clinical development portfolio.

“2021 was a year of important accomplishments for Incyte. Growth of product and royalty revenues was strong, led by robust demand for Jakafi^® (ruxolitinib), continued uptake of Pemazyre^® (pemigatinib) in the U.S., and a rapidly growing royalty revenue stream. Throughout the year, we significantly expanded our commercial portfolio with several new approvals, including Pemazyre^®(pemigatinib) in cholangiocarcinoma (CCA) in Europe and Japan; Minjuvi^® (tafasitamab) in relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in Europe; and, in the U.S., both Jakafi in steroid-refractory chronic graft-versus-host disease (GVHD) and Opzelura^TM (ruxolitinib) cream in atopic dermatitis,” said Hervé Hoppenot, Chief Executive Officer, Incyte. “Our launch of Opzelura has been very successful thus far. Nearly 19,000 patients were treated in the fourth quarter and feedback from both dermatologists and patients has been very positive. Importantly, we have also made significant progress towards ensuring optimal patient access to Opzelura.”

Portfolio Updates

MPNs and GVHD – key highlights

Axatilimab (anti-CSF-1R monoclonal antibody) in chronic GVHD: In December, updated positive data from the Phase 1/2 trial evaluating axatilimab as a monotherapy in patients with recurrent or refractory chronic GVHD despite two or more prior lines of therapy were presented at ASH. A 68% overall response rate

The following information was filed by Incyte Corp (INCY) on Tuesday, February 8, 2022 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Inside Incyte Corp's 10-K Annual Report:

Revenue - Product Highlight
New patient starts for treatment decreased as a result of shelter in place and other protective measures, and if decreases in new patient starts occur in future periods, our revenues in future periods could be adversely affected.

Other - Other Highlight
While we currently believe we are well-positioned to function in a hybrid on-site and virtual or remote fashion, the extent of the COVID-19 Pandemic's effect on our operational and financial performance will depend on future developments, including the duration, spread and intensity of the pandemic, protective measures, and the reimposition of protective measures, implemented by governmental authorities or by us to protect our employees, and effects of the pandemic and such protective measures on our suppliers, collaborators, services providers and healthcare organizations serving patients, all of which are uncertain and difficult to predict considering the rapidly evolving landscape.
Financial - Expense Highlight
The decrease in clinical research and outside services expense from 2020 to 2021 was primarily due to expense related to the purchase of an FDA priority review voucher in the prior year that enabled OPZELURA to be the first JAK inhibitor approved in a topical formulation and due to upfront consideration related to our collaborative agreements recorded in the prior year.
Other - Other Highlight
The Agreement became effective in December 2021 with the expiration of the initial waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.
Financial - Income Highlight
As a result of releasing the valuation allowance on the majority of our U.S. deferred tax assets in 2021, we expect that our reported income tax expense (current plus deferred) for future periods will be higher than that recorded for prior periods.
Financial - Expense
Cost of Product Revenues Cost...Read more
Other - Other
The increase in cash provided...Read more
Revenue - Product
Under the terms of this...Read more
Financial - Earnings
This benefit increased net income...Read more
Revenue - Product
We apply the following five-step...Read more
Financial - Expense
The increase in other contract...Read more
Financial - Expense
This benefit is partially offset...Read more
Revenue - Product
Milestone and Contract Revenues At...Read more
Revenue - Product
Our product revenues may fluctuate...Read more
Other - Other
Customer Credits: Our customers are...Read more
Revenue - Product
In September 2021, we recognized...Read more
Other - Other
We may increase the maximum...Read more
Other - Other
As of December 31, 2021,...Read more
Financial - Debt
Debt financing arrangements may require...Read more
Financial - Expense
The fair value of RSUs...Read more
Revenue - Product
We include milestones in the...Read more
Revenue - Product
We recognize revenue only when...Read more
Other - Other
We also adjust our allowance...Read more
Revenue - Product
Revenues The increase in JAKAFI...Read more
Revenue - Product
Syndax is eligible to receive...Read more
Financial - Debt
Our cash and marketable securities...Read more
Revenue - Product
We expect government rebates and...Read more
Other - Other
Medicare Part D Coverage Gap:...Read more
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During 2021 and 2020, net...Read more
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Our contractual milestones typically relate...Read more

Financial Statements, Disclosures and Schedules

Inside this 10-K Annual Report

Material Contracts, Statements, Certifications & more

Incyte Corp provided additional information to their SEC Filing as exhibits

Exhibit 21.1: Subsidaries Of The Registrant

Exhibit 23.1: Consents Of Experts And Counsel

Exhibit 31.1: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 31.2: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 32.1: Section 1350 Certification

Exhibit 32.2: Section 1350 Certification

Ticker: INCY
CIK: 879169
Form Type: 10-K Annual Report
Accession Number: 0001558370-22-000902
Submitted to the SEC: Tue Feb 08 2022 4:05:11 PM EST
Accepted by the SEC: Tue Feb 08 2022
Period: Friday, December 31, 2021
Industry: Commercial Physical And Biological Research