Supernus Pharmaceuticals (SUPN) FY2025 10-K Risk Factors: 15 New, 15 Dropped

What the changes say

New risks highlight commercial dependence on key products like ZURZUVAE, ONAPGO supply constraints, and recent executive orders impacting pricing.

What changed since the prior 10-K

New

NewRisks Related to Our Industry and Business
We are dependent on the commercial success of our products in the U.S
We depend heavily on U.S. product sales, managed care reimbursement policies, and significant pharmaceutical wholesalers and distributors for commercial success.
NewRisks Related to Our Industry and Business
Ongoing legal actions and proceedings could distract management and could result in substantial costs or large judgments against Supernus or one or more of its subsidiaries
Our commercialization of ZURZUVAE for postpartum depression with partner Biogen carries revenue and execution uncertainties.
NewRisks Related to Our Industry and Business
We are dependent on the commercial success of our products in the U.S
Major products Qelbree, GOCOVRI, Oxtellar XR, APOKYN, and ZURZUVAE drove 49%, 23%, 6%, and 8% of 2025 net revenues.
NewRisks Related to Our Industry and Business
Third parties have, and in the future may, receive approval to manufacture and market their own versions of products containing one or more of the active pharmaceutical ingredients present in our products in the U.S
Generic competition has begun for Trokendi XR and Oxtellar XR, with XADAGO generics permitted starting December 2027.
NewRisks Related to Our Industry and Business
Third parties have developed, received FDA approval and successfully commercialized longer-lasting extended relief levodopa/carbidopa products, which are impacting sales of APOKYN because they reduce the number of times per day a given patient may need to use an off-episode product like APOKYN
Longer-lasting levodopa/carbidopa competitors like AbbVie's Vyalev are impacting APOKYN and ONAPGO sales.
NewRisks Related to Our Industry and Business
The success of these products and the entry of new products could adversely impact the sales of ONAPGO and APOKYN
Intense pricing pressure from government authorities and private payors threatens our reimbursement rates and revenue growth.
NewRisks Related to Our Industry and Business
services. Government authorities and third-party payors have attempted to control costs, in some instances, by limiting coverage, by limiting the amount of reimbursement for particular medications, or by encouraging the use of lower-cost generic products
Payor cost-containment measures, reimbursement limitations, and mandatory discounts could reduce our profitability.
NewRisks Related to Our Industry and Business
regulations and corresponding foreign standards for drug cGMPs. If we fail to comply with these regulations, then it could have a material adverse effect on our business and financial condition
Supplier constraints are impacting our ability to meet strong market demand for ONAPGO due to reliance on third-party manufacturers.
NewRisks Related to Our Industry and Business
In addition to competition for our current commercial products, we anticipate that we will face intense competition if our pipeline product candidates are approved by regulatory authorities and begin their commercialization process
Well-resourced competitors threaten our pipeline products with greater capital, research, and marketing resources.
NewRisks Related to Our Industry and Business
Recent Executive Orders May Impact our Financial Results
2025 Presidential Executive Orders aimed at lowering drug prices and introducing MFN models could reduce commercial product revenues.
NewRisks Related to Our Industry and Business
The Company could be subject to allegations of healthcare fraud and abuse, as well as other violations of healthcare regulations by both the federal government and the states in which the Company conducts its business
Shifting federal executive orders regarding AI in healthcare create evolving regulatory compliance requirements for data safety and privacy.
NewRisks Related to Our Industry and Business
Accordingly, disruptions to the Company's business as a result of a pandemic could result in a material adverse effect on the Company's business, results of operations, financial condition, and prospects in the near and long terms
Pandemic disruptions and ongoing legal actions could cause material adverse effects on our business and financial condition.
NewRisks Related to Our Industry and Business
From time to time and in the ordinary course of business, Supernus Pharmaceuticals, Inc. (Parent) and any of its subsidiaries are and may be subject to additional claims, charges, enforcement actions and litigation
NewRisks Related to Our Industry and Business
In addition, Sage received a subpoena from the Enforcement Division of the SEC in October 2024, requesting documents and information related to its NDA for zuranolone for the treatment of MDD, including communications with the FDA and any communications containing material nonpublic information
NewRisks Related to Our Finances and Capital Requirements
Tariffs may increase our costs

Dropped

Dropped
substantial liabilities; and adversely affect our revenues and financial condition. In the event of a withdrawal of any of our products from the market, our revenues would decline significantly, and our business would be seriously harmed and could fail
Dropped
If generics or other versions of our products including generics containing one or more of the active pharmaceutical ingredients present in our products are approved and successfully commercialized, our business could be materially harmed
Failure to achieve long-term revenue expectations and potential product withdrawals.
Dropped
We are subject to uncertainty relating to payment or managed care reimbursement policies, which, if not favorable for our products or product candidates, could hinder or prevent our commercial success
Generic competition risks specifically citing Upsher-Smith's Qudexy XR.
Dropped
We depend on wholesalers, distributors, and specialty pharmacies for the distribution of our products. If we lose any of our significant wholesaler, distributor, or specialty pharmacy accounts, our business could be harmed
General managed care reimbursement pricing pressures.
Dropped
approval to commercialize our product candidates. We cannot, therefore, predict the timing of any future revenues from these product candidates
Reliance on specific wholesalers and distributors for products like MYOBLOC.
Dropped
working toward meeting these post-marketing commitments for Qelbree in a timely manner. We also have post-marketing commitment to conduct a new leachable study for ONAPGO, which was approved by the FDA in February 2025
Dropped
We also have agreements with leading CMOs to manufacture other commercial products and the API for such products. These CMOs offer a comprehensive range of contract manufacturing services
Dropped
products or technologies to us. The success of this strategy depends partly upon our ability to identify, select, discover and acquire promising pharmaceutical product candidates and approved products, and to manage our spending as expenses related to undertaking clinical trials can be substantial
Dropped
authorities to temporarily or permanently halt product sales, which could have a material adverse effect on our business. As required by the FDA, the labels for our products include precautions and warnings about side effects, and in certain cases, the need for monitoring patients receiving the product
FDA discretion in delaying or denying NCE marketing applications.
Dropped
Healthcare reform measures could hinder or prevent the commercial success of our products or product candidates
Dropped
Additional changes to the HealthCare Reform Law include The American Taxpayer Relief Act of 2012, which reduced Medicare payments to several types of providers and increased the statute of limitations period for the government to recover overpayments to providers from three years to five years
Dropped
Congress may consider other legislation to repeal or replace elements of the HealthCare Reform Law. It is difficult to predict the extent to which any of these changes to the HealthCare Reform Law, or additional changes if made, may impact the Company's business or any financial condition
Dropped
There can be no assurance that any of the Company's plans will be effective in mitigating the effects of a pandemic on our business operations and consequently the potential material adverse impact on our anticipated revenue, earnings and liquidity
DroppedRisks Related to Our Finances and Capital Requirements
Our operating results may fluctuate significantly
Status of post-marketing commitments for Qelbree, ONAPGO, and Oxtellar XR.
DroppedRisks Related to Our Finances and Capital Requirements
SPN-830, received FDA approval in February 2025, certain milestones related to the FDA approval of the SPN-830 NDA were paid in February 2025, and we expect certain of the remaining regulatory and commercial milestone activities to become due and paid in 2025
Contract manufacturing agreements including United Therapeutics for Orenitram.

Reworded

100% rewrittenRisks Related to Our Industry and Business
Final marketing approval of any of our product candidates or approval of additional indications for existing products by the FDA or other regulatory authorities may be delayed, limited, or denied, any of which would adversely affect our ability to generate operating revenues
Shifted focus from general regulatory approval requirements and clinical trials to reliance on outsourcing arrangements and manufacturing volume constraints.
100% rewrittenRisks Related to Our Industry and Business
We face potential litigation and product liability exposures. If successful claims are brought against us, we may incur substantial liabilities
Replaced general litigation and false claims act exposures with specific cybersecurity incident and data breach risks.
100% rewrittenRisks Related to Our Finances and Capital Requirements
Our ability to use our net operating loss carryforwards and other tax attributes may be limited or may expire prior to utilization
Replaced Section 382 net operating loss carryforward limits ($340.6 million) with business acquisition integration and intangible asset impairment risks.
100% rewrittenRisks Related to Our Industry and Business
If our competitors develop or market alternatives for the treatment of our target indications, our commercial opportunities will be reduced or eliminated
Expanded from general industry competition to include collaborative licensing obligations and clinical trial safety or efficacy failure risks.
97% rewrittenRisks Related to Our Industry and Business
Healthcare cost containment legislation and the failure of third-party payors to provide appropriate levels of coverage and reimbursement for the use of products and treatments facilitated by our products could harm our business and prospects
Added specific risks regarding healthcare regulation compliance penalties and patent enforcement litigation.
92% rewrittenRisks Related to Our Industry and Business
Our products and our product candidates may be subject to restrictions or withdrawal from the market. We may be subject to penalties if we fail to comply with regulatory requirements
Updated post-approval commitment examples to include ZURZUVAE alongside Qelbree, ONAPGO, Oxtellar XR, Trokendi XR, and MYOBLOC.
88% rewrittenRisks Related to Our Industry and Business
There can be no assurance that the Company's business will not be materially harmed by future compliance with or changes to the HealthCare Reform Law
Minor grammatical correction adding 'to it' regarding healthcare fraud and anti-kickback statute violations.
Was: The assessment of the financial impact of the HealthCare Reform Law on the Company's business is on-going. There can be no assurance that the Company's business will not be materially harmed by future compliance with or changes to the HealthCare Reform Law
88% rewrittenRisks Related to Our Industry and Business
We may not be able to effectively market and sell our product candidates, if approved, in the U.S
Added a specific warning that re-prioritizing sales representatives for new product launches could harm existing product sales performance.
86% rewrittenRisks Related to Our Industry and Business
We may not obtain or maintain the benefits associated with designation as an orphan drug under the Orphan Drug Act, including market exclusivity
Was: We may not obtain or maintain the benefits associated with Orphan Drug Designation, including market exclusivity
83% rewrittenRisks Related to Our Industry and Business
Our products and product candidates may cause undesirable side effects or have other characteristics that limit their commercial potential, delay, or prevent their regulatory approval
65% rewrittenRisks Related to Our Industry and Business
Refer to Part I, Item 1—Business—Collaborations and Licensing Agreements, of our Annual Report on Form 10-K for discussion on the different collaborations and licensing arrangements
57% rewrittenRisks Related to Our Finances and Capital Requirements
We expect that any revenue we generate will fluctuate from quarter to quarter and year to year as a result of the revenue generated from approved products, license agreements, development milestones, and collaboration license agreements
52% rewrittenRisks Related to Securities Markets and Investment in Our Stock
To the extent outstanding stock options are exercised and restricted stock units and performance stock units vest there will be dilution to new investors
50% rewrittenRisks Related to Our Finances and Capital Requirements
Changes in tax laws or regulations that are applied adversely to us or our customers may have a material adverse effect on our business, cash flow, financial condition or results of operations
50% rewrittenRisks Related to Our Finances and Capital Requirements
We have and may further expand our business through acquisitions of new product lines or businesses, which expose us to various risks, including difficulties in integrating acquisitions. Our recent acquisitions pose certain incremental risks to the Company
45% rewrittenRisks Related to Our Industry and Business
Our commercial success depends upon our ability, and the ability of our collaborators, to develop, manufacture, market and sell our approved products and our product candidates and to use our proprietary technologies without infringing the proprietary rights of third parties
42% rewrittenRisks Related to Our Industry and Business
There are no guarantees that we will be successful in completing these tasks. We will need to continue investing substantial financial and management resources to maintain our commercial sales and marketing infrastructure and recruit and train qualified marketing, sales, and other personnel
37% rewrittenRisks Related to Our Industry and Business
If the FDA or other applicable regulatory authorities approve generic products that compete with any of our products or product candidates, the sales of our products or the commercial success of our product candidates would be adversely affected
35% rewrittenRisks Related to Our Industry and Business
Our failure to successfully develop and market our product candidates would impair our ability to grow
29% rewrittenRisks Related to Our Industry and Business
Even if our product candidates receive regulatory approval in the U.S., we or our collaborators may not receive approval to commercialize our product candidates outside of the U.S
26% rewrittenRisks Related to Our Industry and Business
The Company may also experience other unknown impacts from a pandemic that cannot be predicted. We may also experience delays in receiving supplies of our product candidates from our contract manufacturing organizations due to staffing shortages, production slowdowns, stoppages, or disruptions in delivery systems
26% rewrittenRisks Related to Our Industry and Business
Cybersecurity incidents may adversely impact our financial condition, results of operations, and reputation. Security breaches and other disruptions could compromise our information and expose us to liability which would cause our business and reputation to suffer
24% rewrittenRisks Related to Securities Markets and Investment in Our Stock
The issuance of additional shares of our common stock, or instruments convertible into or rights to acquire shares or our common stock, or market sales of our common stock, could affect the market price of our common stock

All 72 risk factors

Headings as the filing states them, in filing order.

Risks Related to Our Industry and Business

01We are dependent on the commercial success of our products in the U.SNew
02Final marketing approval of any of our product candidates or approval of additional indications for existing products by the FDA or other regulatory authorities may be delayed, limited, or denied, any of which would adversely affect our ability to generate operating revenues100% rewritten
03If our competitors develop or market alternatives for the treatment of our target indications, our commercial opportunities will be reduced or eliminated100% rewritten
04Healthcare cost containment legislation and the failure of third-party payors to provide appropriate levels of coverage and reimbursement for the use of products and treatments facilitated by our products could harm our business and prospects97% rewritten
05We face potential litigation and product liability exposures. If successful claims are brought against us, we may incur substantial liabilities100% rewritten
06Ongoing legal actions and proceedings could distract management and could result in substantial costs or large judgments against Supernus or one or more of its subsidiariesNew
08We are dependent on the commercial success of our products in the U.SNew
09There are no guarantees that we will be successful in completing these tasks. We will need to continue investing substantial financial and management resources to maintain our commercial sales and marketing infrastructure and recruit and train qualified marketing, sales, and other personnel42% rewritten
10Third parties have, and in the future may, receive approval to manufacture and market their own versions of products containing one or more of the active pharmaceutical ingredients present in our products in the U.SNew
11Third parties have developed, received FDA approval and successfully commercialized longer-lasting extended relief levodopa/carbidopa products, which are impacting sales of APOKYN because they reduce the number of times per day a given patient may need to use an off-episode product like APOKYNNew
12The success of these products and the entry of new products could adversely impact the sales of ONAPGO and APOKYNNew
13services. Government authorities and third-party payors have attempted to control costs, in some instances, by limiting coverage, by limiting the amount of reimbursement for particular medications, or by encouraging the use of lower-cost generic productsNew
14Each of our three major customers, Cencora, Inc., Cardinal Health, Inc., and McKesson Corporation, individually accounted for more than 15% of our total product revenue in 2025 and collectively accounted for more than 76% of our total product revenue in 2025
15We may not be able to effectively market and sell our product candidates, if approved, in the U.S88% rewritten
16regulations and corresponding foreign standards for drug cGMPs. If we fail to comply with these regulations, then it could have a material adverse effect on our business and financial conditionNew
17If we do not obtain marketing exclusivity for our product candidates, our business may suffer
18If the FDA or other applicable regulatory authorities approve generic products that compete with any of our products or product candidates, the sales of our products or the commercial success of our product candidates would be adversely affected37% rewritten
19In addition to competition for our current commercial products, we anticipate that we will face intense competition if our pipeline product candidates are approved by regulatory authorities and begin their commercialization processNew
20Our products and our product candidates may be subject to restrictions or withdrawal from the market. We may be subject to penalties if we fail to comply with regulatory requirements92% rewritten
21Refer to Part I, Item 1—Business—Collaborations and Licensing Agreements, of our Annual Report on Form 10-K for discussion on the different collaborations and licensing arrangements65% rewritten
22Even if our product candidates receive regulatory approval in the U.S., we or our collaborators may not receive approval to commercialize our product candidates outside of the U.S29% rewritten
23Our failure to successfully develop and market our product candidates would impair our ability to grow35% rewritten
24Recent Executive Orders May Impact our Financial ResultsNew
25We may be unable to acquire product candidates or products
26Our clinical trials for our product candidates may fail to demonstrate acceptable levels of safety, efficacy, or other requirements, which could prevent or significantly delay regulatory approval
27Delays or failures in the completion of clinical development of our product candidates would increase our costs, and delay, or limit our ability to generate revenues
28Our products and product candidates may cause undesirable side effects or have other characteristics that limit their commercial potential, delay, or prevent their regulatory approval83% rewritten
29We may not obtain or maintain the benefits associated with designation as an orphan drug under the Orphan Drug Act, including market exclusivity86% rewritten
30There can be no assurance that the Company's business will not be materially harmed by future compliance with or changes to the HealthCare Reform Law88% rewritten
31The Company could be subject to allegations of healthcare fraud and abuse, as well as other violations of healthcare regulations by both the federal government and the states in which the Company conducts its businessNew
32Guidelines and recommendations published by various organizations can reduce the use of our products and product candidates
33We could be involved in additional lawsuits to protect or enforce our patents, which could be expensive, time consuming, distracting, and ultimately unsuccessful
34For more information, refer to Part I, Item 3—Legal Proceedings contained in this Annual Report Form 10-K
35Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation
36Limitations on our patent rights relating to our products and product candidates may limit our ability to prevent third parties from competing with us
37Our commercial success depends upon our ability, and the ability of our collaborators, to develop, manufacture, market and sell our approved products and our product candidates and to use our proprietary technologies without infringing the proprietary rights of third parties45% rewritten
38As we continue to increase the size of our organization, we may experience difficulties in managing growth
39Cybersecurity incidents may adversely impact our financial condition, results of operations, and reputation. Security breaches and other disruptions could compromise our information and expose us to liability which would cause our business and reputation to suffer26% rewritten
40The continued occurrence of high-profile data breaches provides evidence of an external environment which is increasingly hostile to information security and to the secure processing, maintenance, and transmission of information critical to our operations and business strategy
41While integrating acquired businesses and operations and upgrading the Company's information technology systems, we may face an elevated cybersecurity risk
42Our business involves the use of hazardous materials, and we must comply with environmental laws and regulations. This can be expensive and restrict how we do business
43Provisions in our agreement with Shire, or its successor, Takeda Pharmaceutical Company Limited, impose restrictive covenants on us, which could limit our ability to operate effectively in the future
44The Company’s financial condition and results of operations may be materially and adversely affected by health pandemics
45The Company may also experience other unknown impacts from a pandemic that cannot be predicted. We may also experience delays in receiving supplies of our product candidates from our contract manufacturing organizations due to staffing shortages, production slowdowns, stoppages, or disruptions in delivery systems26% rewritten
46Accordingly, disruptions to the Company's business as a result of a pandemic could result in a material adverse effect on the Company's business, results of operations, financial condition, and prospects in the near and long termsNew
47From time to time and in the ordinary course of business, Supernus Pharmaceuticals, Inc. (Parent) and any of its subsidiaries are and may be subject to additional claims, charges, enforcement actions and litigationNew
48In addition, Sage received a subpoena from the Enforcement Division of the SEC in October 2024, requesting documents and information related to its NDA for zuranolone for the treatment of MDD, including communications with the FDA and any communications containing material nonpublic informationNew

Risks Related to Our Finances and Capital Requirements

07Our ability to use our net operating loss carryforwards and other tax attributes may be limited or may expire prior to utilization100% rewritten
49Tariffs may increase our costsNew
50We expect that any revenue we generate will fluctuate from quarter to quarter and year to year as a result of the revenue generated from approved products, license agreements, development milestones, and collaboration license agreements57% rewritten
51Maintaining effective internal control over financial reporting is necessary for us to produce reliable financial statements. Effective internal control over financial reporting and adequate disclosure controls and procedures are designed to prevent fraud
52information timely and accurately could be adversely affected. As a result, we could lose investor confidence and become subject to litigation or investigations, which could adversely affect our business, operations, financial condition and the trading price of our Common Stock
53We have and may further expand our business through acquisitions of new product lines or businesses, which expose us to various risks, including difficulties in integrating acquisitions. Our recent acquisitions pose certain incremental risks to the Company50% rewritten
54Any impairment in the value of our intangible assets, including goodwill, could negatively affect our operating results and total capitalization
55Changes in tax laws or regulations that are applied adversely to us or our customers may have a material adverse effect on our business, cash flow, financial condition or results of operations50% rewritten
56In recent years, we have focused primarily on marketing our current products and developing our product candidates, with the goal of supporting regulatory approval for our product candidates. We have financed our operations through revenue generated from operations and various financing transactions

Risks Related to Securities Markets and Investment in Our Stock

57The issuance of additional shares of our common stock, or instruments convertible into or rights to acquire shares or our common stock, or market sales of our common stock, could affect the market price of our common stock24% rewritten
58The price of our common stock may fluctuate substantially
59Anti-takeover provisions under our charter documents and Delaware law could delay or prevent a change of control, which could negatively impact the market price of our common stock
60To the extent outstanding stock options are exercised and restricted stock units and performance stock units vest there will be dilution to new investors52% rewritten
61Indebtedness and liabilities could limit the cash flow available for our operations, expose us to risks that could adversely affect our business, financial condition, and results of operations, and impair our ability to satisfy our obligations under the notes
62Our Credit Line is an uncommitted debt facility that may be terminated by the lender at any time
63Obtaining and maintaining patent protection depends on compliance with various procedural, document submission, fee payment, and other requirements imposed by governmental patent agencies. Our patent protection could be reduced or eliminated for non-compliance with these requirements
64Our insurance coverage may not be sufficient to cover our legal claims or other losses that we may incur in the future
65We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers
66We may enter into significant, complex, and unusual transactions, which may require us to engage outside consultants and financial professionals in order to comply with complex accounting and reporting requirements
67Our operations rely on sophisticated information technology, systems, and infrastructure, a disruption of which could harm our operations
68In addition, unforeseen circumstances may arise, or our strategic imperatives could change, causing us to consume capital significantly faster than we currently anticipate, requiring us to raise additional funds. We have no committed external sources of funds
69Complying with increased financial reporting and securities laws reporting requirements has increased our costs and requires additional management resources. We may fail to meet these obligations
70As a public company, we are subject to Section 404 of SOX relating to internal control over financial reporting. We have and expect to continue to incur significant expense and to devote substantial management effort toward ensuring compliance with Section 404
71We have never paid dividends. Because we do not anticipate paying any cash dividends in the foreseeable future, capital appreciation, if any, of our common stock will be your sole source of gain on an investment in our common stock
72Unstable market and economic conditions may have serious adverse consequences on our business, financial condition and stock price

Other Supernus Pharmaceuticals 10-Ks

FY2024 10-K risk factors
72 risks
This is a new filing without prior year risk factors. The risk profile is dominated by reliance on three major distributors for product sales, competition from generic drug manufacturers, and regulatory dependencies for product approvals and post-marketing commitments.
Filed Feb 25, 2025

About this page

The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.