Company: SUPN
Filing Date: 2025-02-25
Form Type: 10-K
Source: 0001356576-25-000017
Chunk: 455

Company: SUPERNUS PHARMACEUTICALS, INC.
Filing Date: 2025-02-25
Form: 10-K
Item: Item 1A
Chunk 455
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•    The level of market acceptance for any approved product candidate, underlying demand for our products, and wholesalers' buying patterns;

•    Variations in the level of expenses related to our development programs;

•    The success of our product development and clinical trial activities through all phases of clinical development;

•    Our execution of any collaborative, licensing, or similar commercial arrangements, and the timing of payments we may make or receive under these arrangements;

•    Any delays in regulatory review and approval of product candidates in clinical development;

•    The timing of any regulatory approvals, if received, of additional indications for our existing products;

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Table of ContentsITEM 1A. RISK FACTORS.

•    Potential side effects of our products and our future products that could delay or prevent commercialization, cause an approved drug to be taken off the market, or result in litigation;

•    Any intellectual property infringement lawsuit in which we may become involved;

•    Our ability to maintain an effective sales and marketing infrastructure;

•    Our dependence on third-party manufacturers to supply or manufacture our products and product candidates;

•    Competition from existing products, new products, or potential generics to our products or to competitive products that may emerge;

•    Regulatory developments affecting our products and product candidates;

•    Increased costs as a result of inflation, unstable economic conditions and geopolitical events, including increases in compensation and professional expenses, cost of goods sold, and research and development expenses;

•    Changes in reimbursement environment and regulatory changes; and 

•Changes in the size of our investment portfolio, borrowings and interest rates. 

Due to the various factors mentioned above, and others, the results of any prior quarterly period should not be relied upon as an indication of our future operating performance. If our quarterly operating results fall below the expectations of investors or securities analysts, the price of our common stock could decline substantially. Furthermore, any quarterly fluctuations in our operating results may, in turn, cause the price of our stock to fluctuate substantially.

Our ability to use our net operating loss carryforwards and other tax attributes may be limited or may expire prior to utilization.

Our ability to utilize our U.S. federal and state net operating losses is currently limited and may be limited further, under Sections 382 of the Internal Revenue Code. The limitations apply if an ownership change, as defined by Section 382, occurs. Generally, an ownership change occurs when certain shareholders change their aggregate ownership position by more than 50