INCYTE CORP
For the period ended Dec 31, 2024. Filed Feb 10, 2025.
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A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2024 · Filed Feb 10, 2025
Contents
Forward-Looking Statements
This report contains forward-looking statements that involve risks and uncertainties. These statements relate to future periods, future events or our future operating or financial plans or performance. Often, these statements include the words “believe,” “expect,” “target,” “anticipate,” “intend,” “plan,” “seek,” “estimate,” “potential,” or words of similar meaning, or future or conditional verbs such as “will,” “would,” “should,” “could,” “might,” or “may,” or the negative of these terms, and other similar expressions. These forward-looking statements include statements as to:
the discovery, development, formulation, manufacturing and commercialization of our compounds, our drug candidates and JAKAFI®/JAKAVI® (ruxolitinib), PEMAZYRE® (pemigatinib), ICLUSIG® (ponatinib), MONJUVI®(tafasitamab-cxix) / MINJUVI® (tafasitamab), OPZELURA® (ruxolitinib) cream, ZYNYZ® (retifanlimab-dlwr) and NIKTIMVOTM (axatilimab);
our plans to further develop our operations outside of the United States;
conducting clinical trials internally, with collaborators, or with clinical research organizations;
our collaboration and strategic relationship strategy, and anticipated benefits and disadvantages of entering into collaboration agreements;
our licensing, investment and commercialization strategies, including our plans to commercialize our drug products and drug candidates;
the regulatory approval process, including obtaining U.S. Food and Drug Administration and other international regulatory authorities’ approval for our products in the United States and abroad;
the safety, effectiveness and potential benefits and indications of our drug candidates and other compounds under development;
the timing and size of our clinical trials; the compounds expected to enter clinical trials; timing of clinical trial results;
our ability to manage expansion of our drug discovery and development operations;
future required expertise relating to clinical trials, manufacturing, sales and marketing;
obtaining and terminating licenses to products, drug candidates or technology, or other intellectual property rights;
the receipt from or payments pursuant to collaboration or license agreements resulting from milestones or royalties;
plans to develop and commercialize products on our own;
plans to use third-party manufacturers;
plans for our manufacturing operations;
expected expenses and expenditure levels; expected uses of cash; expected revenues and sources of revenues, including milestone payments; expectations with respect to inventory;
expectations with respect to reimbursement for our products;
the expected impact of recent accounting pronouncements and changes in tax laws;
expected losses; fluctuation of losses; currency translation impact associated with non-U.S. operations and collaboration royalties;
our profitability; the adequacy of our capital resources to continue operations;
the need to raise additional capital;
the costs and other financial impacts associated with resolving matters in litigation and governmental proceedings;
our expectations regarding competition;
our investments, including anticipated expenditures, losses and expenses; and
our patent prosecution and maintenance efforts.
These forward-looking statements reflect our current views with respect to future events, are based on assumptions and are subject to risks and uncertainties. These risks and uncertainties could cause actual results to differ materially from those projected and include, but are not limited to:
our ability to successfully commercialize our drug products and drug candidates;
our ability to obtain, or maintain at anticipated levels, coverage and reimbursement for our products from government health administration authorities, private health insurers and other organizations;
our ability to establish and maintain effective sales, marketing and distribution capabilities;
the risk of reliance on other parties to manufacture our products, which could result in a short supply of our products, increased costs, and withdrawal of regulatory approval;
our ability to maintain regulatory approvals to market our products;
our ability to achieve a significant market share in order to achieve or maintain profitability;
the risk of civil or criminal penalties if we market our products in a manner that violates health care fraud and abuse and other applicable laws, rules and regulations;
our ability to discover, develop, formulate, manufacture and commercialize our drug candidates;
the risk of unanticipated delays in, or discontinuations of, research and development efforts;
the risk that previous preclinical testing or clinical trial results are not necessarily indicative of future clinical trial results;
risks relating to the conduct of our clinical trials, including geopolitical risks;
changing regulatory requirements;
the risk of adverse safety findings;
the risk that results of our clinical trials do not support submission of a marketing approval application for our drug candidates;
the risk of significant delays or costs in obtaining regulatory approvals;
risks relating to our reliance on third-party manufacturers, collaborators, and clinical research organizations;
risks relating to the development of new products and their use by us and our current and potential collaborators;
risks relating to our inability to control the development of out-licensed compounds or drug candidates;
risks relating to our collaborators’ ability to develop and commercialize drug products and the drug candidates licensed from us;
costs associated with prosecuting, maintaining, defending and enforcing patent claims and other intellectual property rights;
our ability to maintain or obtain adequate product liability and other insurance coverage;
the risk that our drug candidates may not obtain or maintain regulatory approval;
the impact of technological advances and competition, including potential generic competition;
our ability to compete against third parties with greater resources than ours;
risks relating to changes in pricing and reimbursement in the markets in which we may compete;
risks relating to governmental healthcare reform efforts, including efforts to control, set or cap pricing for our commercial drugs in the U.S. and abroad;
competition to develop and commercialize similar drug products;
our ability to obtain and maintain patent protection and freedom to operate for our discoveries and to continue to be effective in expanding our patent coverage;
the impact of changing laws on our patent portfolio;
developments in and expenses relating to litigation and governmental proceedings;
our ability to in-license drug candidates or other technology;
unanticipated delays or changes in plans or regulatory agency interactions or other issues relating to our large molecule production facility;
our ability to integrate successfully acquired businesses, development programs or technology;
our ability to obtain additional capital when needed;
fluctuations in net cash provided and used by operating, financing and investing activities;
our ability to analyze the effects of new accounting pronouncements and apply new accounting rules;
risks relating to our ability to sustain profitability;
risks related to public health pandemics such as the COVID-19 pandemic, natural disasters, or geopolitical events such as the Russian invasion of Ukraine and conflicts in the Middle East; and
the risks set forth under “Risk Factors.”
Given these risks and uncertainties, you should not place undue reliance on these forward-looking statements. Except as required by federal securities laws, we undertake no obligation to update any forward-looking statements for any reason, even if new information becomes available or other events occur in the future.
In this report all references to “Incyte,” “we,” “us,” “our” or the “Company” mean Incyte Corporation and our subsidiaries, except where it is made clear that the term means only the parent company.
Incyte, JAKAFI, MINJUVI, MONJUVI, OPZELURA, PEMAZYRE and ZYNYZ are our registered trademarks and NIKTIMVO is our trademark. We also refer to trademarks of other corporations and organizations in this Annual Report on Form 10-K.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.