What changed in this filing

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Item 1. Business

2026-02-26 compared with 2025-02-27 · 113 added, 92 removed, 512 unchanged (29% of the section changed)

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We have developed, licensed, and acquired a portfolio of meaningfully differentiated products for use in the treatment of attention deficit hyperactivity disorder (“ADHD”) and moderate to severe pain.

We commercialize our products, consisting of Jornay PM (“Jornay”), Belbuca, Xtampza ER (“Xtampza”), Nucynta ER and Nucynta IR (collectively the “Nucynta Products”), and Symproic, in the United States.

On September 3, 2024, we acquired Ironshore, which had developed and obtained commercial approval to market Jornay in the United States.

Jornay is a central nervous system (“CNS”) stimulant prescription medicine that contains methylphenidate HCl, a Schedule II methylphenidate, which was approved by the U.S.

We commercialize our products, consisting of Jornay PM, Belbuca, Xtampza ER, Nucynta ER and Nucynta IR (collectively the “Nucynta Products”), and Symproic, in the United States.

On September 3, 2024, we acquired Ironshore, which had developed and obtained commercial approval to market Jornay PM in the United States.

Jornay PM is a central nervous system (“CNS”) stimulant prescription medicine that contains methylphenidate HCl, a Schedule II methylphenidate, which was approved by the U.S.

Food and Drug Administration (“FDA”) in August 2018 for the treatment of ADHD in people six years of age and older and currently the only FDA-approved stimulant medication that is dosed in the evening.

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The two main sources of real-world abuse, misuse, and diversion data are RADARS® and Inflexxion, an IBH Company.

The Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) System collects product-and geographically-specific data on abuse, misuse, and diversion of prescription drugs through

its multiple data sources.

The Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) System collects product-and geographically-specific data on abuse, misuse, and diversion of prescription drugs through its multiple data sources.

Abuse, misuse, and diversion of Xtampza ER has remained low compared to commonly abused Schedule II opioid analgesics since its introduction into the U.S.

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The RADARS data represents a single snapshot in time and is subject to change.

Therefore, we plan to continue monitoring real world data characterizing the rate of abuse, misuse, and diversion of Xtampza.

Therefore, we plan to continue monitoring real world data characterizing the rate of abuse, misuse, and diversion of Xtampza ER.

Nucynta Products

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In June 2024, the FDA granted pediatric exclusivity to the Nucynta Products for an additional six months, to January 3, 2027 for Nucynta IR and December 27, 2025 for Nucynta ER.

We have entered into an authorized generic agreement with Hikma Pharmaceuticals USA Inc.

(“Hikma”), pursuant to which we granted Hikma rights relating to an authorized generic version of the Nucynta Products in the United States.

In January 2026, a generic equivalent of Nucynta IR 50mg, 75mg and 100mg tablets was approved under an abbreviated New Drug Application (“ANDA”) filed by a third party with the FDA, which carves out pediatric use from its label.

As a result of the anticipated launch of the third-party generic equivalent of Nucynta IR, Hikma launched a generic version of Nucynta IR on February 25, 2026.

Hikma is expected to launch a generic version of Nucynta ER in the first quarter of 2026.

Symproic, an oral formulation of naldemedine, was approved by the FDA in March 2017 for the treatment of opioid-induced constipation (“OIC”) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.

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Diagnosis of ADHD requires a comprehensive clinical evaluation based on identifying patients who exhibit the core symptoms of inattention, hyperactivity, and impulsivity.

In the United States, it is estimated that 10.5% or 6.5 million children and 6.0% or 15.5 million adults have a current diagnosis of ADHD.

In 2022–2023, approximately 11.4% of children or 7.1 million aged 3–17 and 6% of adults or 15.5 million had a current diagnosis of ADHD in the United States.

ADHD often begins in childhood and can persist into adulthood.

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adult population suffer from high-impact chronic pain that frequently limits life or work activities.

A 2011 report from the Institute of Medicine estimated that chronic pain costs the U.S.

between $560.0 and $635.0 billion per year in direct medical costs and lost productivity, which does not include the cost of care for institutionalized individuals (e.g., nursing home residents, prisoners), military personnel, or children, or the costs associated with caregiving.

In 2021, the economic costs of chronic pain in the United States were estimated to be $722.8 billion, including $530.6 billion in medical care costs and $192.2 billion in lost work productivity, which does not include the cost of care for institutionalized individuals (e.g., nursing home residents, prisoners), military personnel, or children, or the costs associated with caregiving.

The estimated annual costs of chronic pain exceed the costs for heart disease, cancer, and diabetes.

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Centers for Disease Control and Prevention (“CDC”) has described abuse of prescription drugs in the United States as a vast and deadly epidemic.

The beginning of the opioid overdose epidemic in

the late 1990s was marked by a rise in prescription opioid overdose deaths.

For a variety of reasons, heroin use began increasing in the mid-2000s, and had surpassed prescription opioids as a cause of opioid-related overdose by 2016.

The beginning of the opioid overdose epidemic in the late 1990s was marked by a rise in prescription opioid overdose deaths.

For a variety of reasons, heroin use began increasing in 2010, and had surpassed prescription opioids as a cause of opioid-related overdose by 2016.

Meanwhile, the predominant opioid cause of death in 2013 involved synthetic opioids other than methadone.

While opioid-related overdose deaths declined slightly in 2018 (in contrast to the sharp increases during 2014 to 2017), the number of drug overdose deaths was still four times higher in 2018 than in 1999.

While opioid-related overdose deaths declined slightly in 2018 (in contrast to the sharp increases during 2014 to 2017), the number of drug overdose deaths was still ten times higher in 2023 than in 1999.

Despite heightened awareness of the risks associated with opioid use, abuse of prescription opioids, including extended-release formulations, continues to be a public health issue.

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Manufacturing of Our Products

Jornay is manufactured pursuant to supply agreements with third-party manufacturers.

Jornay drug product is manufactured by Coating Place Inc, in Verona, Wisconsin.

Capsules are then shipped to Patheon in Manati, Puerto Rico to be bottled and packed.

Jornay PM is manufactured pursuant to supply agreements with third-party manufacturers.

Jornay PM drug product is manufactured by Coating Place Inc, in Verona, Wisconsin.

Starting in 2026, capsules will be shipped to Patheon in Cincinnati, Ohio to be bottled and packed.

This manufacturing process was previously performed by Patheon in Manati, Puerto Rico.

Belbuca and Symproic are manufactured pursuant to supply agreements with third-party manufacturers.

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Paul, Minnesota.

Belbuca laminate is then sent to either LTS Therapy Systems (formerly Tapemark) in St.

Paul, Minnesota or Sharp Packaging Solutions in Allentown, Pennsylvania or Adhesives Research in Glen Rock, Pennsylvania where it is converted into individual dosage units and, ultimately, into finished goods.

For the Belbuca product portfolio, we are currently qualifying alternate bulk and secondary packaging operations at our existing manufacturer’s sites.

Belbuca laminate is then sent to LTS Therapy Systems (formerly Tapemark) in St.

Paul, Minnesota where it is converted into individual dosage units and, ultimately, into finished goods.

Xtampza ER is manufactured using a proprietary process.

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The API used to formulate the products in our portfolio and DEA drug scheduling are as follows:

DEA Drug Schedule

Methylphenidate

Buprenorphine

Not a controlled substance

Product API DEA Drug Schedule

Xtampza ER Oxycodone Schedule II

Nucynta IR Tapentadol Schedule II

Nucynta ER Tapentadol Schedule II

Jornay PM Methylphenidate Schedule II

Belbuca Buprenorphine Schedule III

Symproic Naldemedine Not a controlled substance

Oxycodone, tapentadol, methylphenidate, and buprenorphine are classified as narcotic controlled substances under U.S.

Xtampza ER, Jornay and the Nucynta Products are classified by the DEA as Schedule II controlled substances, meaning these products have a high potential for abuse and dependence but are recognized as having an accepted medical use.

Xtampza ER, Jornay PM and the Nucynta Products are classified by the DEA as Schedule II controlled substances, meaning these products have a high potential for abuse and dependence but are recognized as having an accepted medical use.

Belbuca is classified as a Schedule III controlled substance, meaning it has a moderate to low potential for abuse.

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Our pain sales force consists of approximately 105 sales representatives and managers that call on the approximately 10,000 health care professionals who write approximately 67% of the branded extended-release opioid prescriptions in the United States, with a primary focus on pain specialists.

Our ADHD sales force consists of approximately 150 sales representatives and managers – and we expect to expand that number to approximately 180 in the first half of 2025 – that call on the approximately 13,000 health care professionals who write approximately 53% of the pediatric and adolescent extended release stimulant prescriptions in the United Sates.

Our ADHD sales force consists of approximately 200 sales representatives and managers that call on the approximately 21,000 health care professionals who write approximately 60% of the pediatric and adolescent extended release stimulant prescriptions in the United States.

We also employ a market-access team to support our formulary approval and payor contracting across our portfolio.

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Finally, we have six patent applications pending in the United States, one pending patent application in each of Canada and Japan, and one pending Patent Cooperation Treaty (“PCT”) application.

Our issued U.S.

patents are projected to expire in 2025, 2030, and 2036 and our pending patent applications in the United States, if issued, would be projected to expire in 2030 and 2036.

One of our issued U.S.

patents expired in 2025 and the remaining are projected to expire in 2030 and 2036.

Our pending patent applications in the United States, if issued, would be projected to expire in 2030 and 2036.

In addition, we use a unique and proprietary process to manufacture our products that requires significant know-how, which we currently protect as trade secrets.

Nucynta IR is protected by one issued patent in the United States (which covers both the drug substance and drug product) that is projected to expire in 2025.

Nucynta IR is protected by one issued patent in the United States (which covers both the drug substance and drug product) that expired in 2025.

Nucynta IR is also covered by New Patient Population exclusivity in pediatric patients that is projected to expire in 2027.

Nucynta ER is protected by three issued patents in the United States (which cover the drug substance, drug product, certain characteristics of the dosage form, and methods of treating patients) that are projected to expire in 2025, 2028, and 2029.

Nucynta ER is protected by three issued patents in the United States (which cover the drug substance, drug product, certain characteristics of the dosage form, and methods of treating patients), one of which expired in 2025 and the remaining two are projected to expire in 2028 and 2029.

Belbuca is protected by three issued patents in the United States (which cover a method of treating patients) that are projected to expire in 2027 and 2032.

Jornay is protected by sixteen patents in the United States (which cover the pharmaceutical composition, formulation, and methods of treating patients) that are projected to expire in 2032.

Jornay PM is protected by sixteen patents in the United States (which cover the pharmaceutical composition, formulation, and methods of treating patients) that are projected to expire in 2032.

We are party to a license agreement with Grünenthal Gmbh (the “Grünenthal License”) pursuant to which we license the right to commercialize the Nucynta Products in the United States and its territories and a license agreement with Shionogi (the “Shionogi License”) pursuant to which we license the right to commercialize Symproic in the United States and its territories.

We have concluded that some of our technology is best protected as proprietary know-how, rather than through obtaining patents.

Except for the Grünenthal License and the Shionogi License, our technology and products are not in-licensed from any third party, and we own all of the rights to Xtampza ER, Belbuca and Jornay.

Except for the Grünenthal License and the Shionogi License, our technology and products are not in-licensed from any third party, and we own all of the rights to Xtampza ER, Belbuca and Jornay PM.

We believe we have freedom to operate in the United States and other countries, but there can be no assurance that other companies, known and unknown, will not attempt to assert their intellectual property against us.

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(the “Nucynta Acquisition”);

Symproic in connection with our acquisition of BioDelivery Sciences Internations, Inc.

Belbuca and Symproic in connection with our acquisition of BioDelivery Sciences International, Inc.

(“BDSI”) (“the BDSI Acquisition”);

and Jornay in connection with the acquisition of Ironshore.

and Jornay PM in connection with the acquisition of Ironshore.

Our business depends upon the skills, knowledge and experience of our scientific and technical personnel, as well as that of our advisors, consultants and other contractors.

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Our industry is characterized by rapidly advancing technologies, intense competition, and a strong emphasis on proprietary products.

Our competitors include major multinational pharmaceutical companies, biotechnology

companies and universities and other research institutions.

However, our primary source of competition stems from the generic opioid and stimulant markets, including both long-acting/extended-release and immediate-release opioid drugs, although non-opioid alternative drugs are being developed and marketed by a number of other pharmaceutical and biotechnology companies such as Vertex Pharmaceuticals Incorporated which in January 2025 obtained approval for suzetrigine for the treatment of moderate to severe acute pain in adults.

Our competitors include major multinational pharmaceutical companies, biotechnology companies and universities and other research institutions.

However, our primary source of competition stems from the generic opioid and stimulant markets, including both long-acting/extended-release and immediate-release drugs.

Non-opioid alternative drugs are also being developed and marketed by a number of other pharmaceutical and biotechnology companies, such as Vertex Pharmaceuticals Incorporated, which in January 2025 obtained approval for suzetrigine for the treatment of moderate to severe acute pain in adults.

Belbuca, Xtampza ER, and the Nucynta Products compete with oral opioids, transdermal opioids, local anesthetic patches, and implantable and external infusion pumps that can be used for infusion of opioids and local anesthetics.

Jornay competes with currently marketed, branded and generic ethylphenidate products for the treatment of ADHD.

Jornay PM competes with currently marketed, branded and generic methylphenidate products for the treatment of ADHD.

Most of the existing and potential competitors have significantly more financial and other resources than we do.

We believe the key competitive factors that will affect the commercial success of our products include the therapeutic efficacy, convenience of dosing and distribution and, in the case of Xtampza ER, the degree of abuse deterrence of competing products, as well as their safety, cost and tolerability profiles.

We believe the key competitive factors that will affect the commercial success of our products include the

therapeutic efficacy, convenience of dosing and distribution and, in the case of Xtampza ER, the degree of abuse deterrence of competing products, as well as their safety, cost and tolerability profiles.

Government Regulation

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• satisfactory completion of an FDA pre-approval inspection of the facility or facilities at which the product is manufactured to assess compliance with the FDA’s current good manufacturing practices (“cGMP”) and regulations;

● submission to the FDA of a NDA or, in the case of a generic drug, an abbreviated NDA (“ANDA”);

• submission to the FDA of a NDA or, in the case of a generic drug, an ANDA;

• satisfactory completion of a review by an FDA advisory committee, if convened;

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An IRB is charged with protecting the welfare and rights of trial participants and considers such items as whether the risks to individuals participating in the clinical trials are minimized and are reasonable in relation to anticipated benefits.

The IRB also approves the informed consent form that must be provided to each clinical trial subject or his or her legal representative and must monitor the clinical trial until completed.

The IRB also approves the informed consent form that must be

provided to each clinical trial subject or his or her legal representative and must monitor the clinical trial until completed.

There are also requirements governing the reporting of ongoing clinical trials and completed clinical trial results to public registries such as www.ClinicalTrials.gov.

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and information provided to prescribers about the existence of the REMS and the strong recommendation that they complete the available training.

Prescriber training required to be offered as part of the REMS is conducted by accredited, independent continuing education providers, without cost to healthcare professionals, under unrestricted grants funded by the opioid analgesic manufacturers.

Prescriber training required to be offered as part of the REMS is conducted by accredited, independent continuing education providers, without cost to healthcare professionals, under

unrestricted grants funded by the opioid analgesic manufacturers.

Moreover, REMS assessments must be submitted on an annual basis to assess the extent to which the ETASU are meeting the goals of the REMS and whether the goals or elements should be modified.

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On October 31, 2024, FDA approved a modification to the opioid analgesic REMS to require manufacturers of opioid analgesics dispensed in outpatient settings to provide pre-paid drug mail-back envelopes (“MBEs”) upon request to become available by March 31, 2025 to pharmacies and other dispensers of opioid analgesics.

As of March 31, 2025, we have made MBEs available on request by pharmacies in accordance with this requirement.

Any products mailed-back under this program are sent to a destruction site that operates in compliance with DEA regulations

Advertising and Promotion

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In late 2024, the FDA announced it is allowing a further exemption period for eligible trading partners who have successfully completed or made documented efforts to complete data connections with their immediate trading partners but still face challenges exchanging data.

The exemption period for eligible manufacturers and repackagers now extends until May 27, 2025.

The exemption period for eligible manufacturers and repackagers extended until May 27, 2025.

The law’s requirements include the quarantine and prompt investigation of a suspicious product, to determine if it is illegitimate, notifying trading partners and the FDA of any illegitimate product, and compliance with product tracking and tracing requirements.

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Registration subjects entities to periodic announced or unannounced inspections by the FDA or these state agencies, during which the agency inspects manufacturing facilities to assess compliance with cGMPs.

Regulatory authorities may withdraw product approvals, request product recalls, or take other punitive action if a company fails to comply with regulatory standards, if it encounters problems following initial marketing, or if previously unrecognized problems are subsequently discovered.

Regulatory authorities may withdraw product approvals, request product recalls, or take

other punitive action if a company fails to comply with regulatory standards, if it encounters problems following initial marketing, or if previously unrecognized problems are subsequently discovered.

The FDA may require post-approval studies, including post-marketing surveillance and observational studies and clinical trials, if the FDA finds that scientific data, including information regarding related drugs, warrant them.

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The FDA held a meeting of the Anesthetic and Analgesic Drug Products Advisory Committee on April 19, 2023.

The committee discussed post-marketing requirements (“PMRs”) 3033-11, issued to holders of NDAs for extended-release and long-acting opioid analgesics to evaluate long-term efficacy of opioid analgesics and the risk of opioid-induced

hyperalgesia.

The discussion focused on a clinical trial designed to address these objectives.

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A pharmaceutical product may be listed as Schedule II, III, IV or V, with Schedule II substances considered to present the highest risk of abuse and Schedule V substances the lowest relative risk of abuse among such substances.

Jornay, Xtampza ER, and the Nucynta Products are listed by the DEA as Schedule II controlled substances under the CSA, while Belbuca is listed as a Schedule III controlled substance.

Jornay PM, Xtampza ER, and the Nucynta Products are listed by the DEA as Schedule II controlled substances under the CSA, while Belbuca is listed as a Schedule III controlled substance.

Consequently, the manufacturing, shipping, storing, selling and use of these products is subject to a high degree of regulation.

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The limited aggregate amount of opioids that the DEA allows to be produced in the United States each year is allocated among individual companies, who must submit applications, at least twice a year, to the DEA for individual production and procurement quotas.

Jornay, Xtampza ER, and the Nucynta Products are regulated as Schedule II controlled substances, and thus, are subject to the DEA’s production and procurement quota system.

Our contract manufacturers must receive a quarterly quota from the DEA to produce or procure any Schedule I or Schedule II substance, including methylphenidate for use in manufacturing

Jornay, oxycodone base for use in manufacturing Xtampza ER and tapentadol for use in manufacturing the Nucynta Products.

Jornay PM, Xtampza ER, and the Nucynta Products are regulated as Schedule II controlled substances, and thus, are subject to the DEA’s production and procurement quota system.

Our contract manufacturers must receive a quarterly quota from the DEA to produce or procure any Schedule I or Schedule II substance, including methylphenidate for use in manufacturing Jornay PM, oxycodone base for use in manufacturing Xtampza ER and tapentadol for use in manufacturing the Nucynta Products.

The DEA may adjust aggregate production quotas and individual production and procurement quotas from time to time during the year, although the DEA has substantial discretion in whether or not to make such adjustments.

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§ 1320a-7b(b)) prohibits knowingly and willfully soliciting, receiving, offering or providing remuneration, directly or indirectly, to induce either the referral of an individual, or the furnishing, recommending, or arranging for a good or service, for which payment may be made under a federal healthcare program such as the Medicare and Medicaid programs.

Remuneration is not defined in the AKS and has been broadly interpreted to include anything of value, including for example, gifts, discounts, coupons, the furnishing of supplies or equipment, credit arrangements, payments of cash, waivers of payments, ownership interests and providing anything at less than its fair market value.

Remuneration is not defined in the AKS and has been broadly

interpreted to include anything of value, including for example, gifts, discounts, coupons, the furnishing of supplies or equipment, credit arrangements, payments of cash, waivers of payments, ownership interests and providing anything at less than its fair market value.

Under the AKS and the applicable criminal healthcare fraud statutes, a person or entity need not have actual knowledge of this statute or specific intent to violate it in order to have committed a violation.

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However, the lack of uniform court interpretation of the AKS makes compliance with the law difficult.

Violations of the AKS can

result in significant criminal fines, exclusion from participation in Medicare and Medicaid and follow-on civil litigation, among other things, for both entities and individuals.

Violations of the AKS can result in significant criminal fines, exclusion from participation in Medicare and Medicaid and follow-on civil litigation, among other things, for both entities and individuals.

Other federal healthcare fraud-related laws also provide criminal liability for violations.

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HITECH also created four new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce HIPAA and seek attorneys’ fees and costs associated with pursuing federal civil actions.

The federal Physician Payments Sunshine Act, created under the ACA, and its implementing regulations, requires manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program to report annually to the CMS under the Open Payments Program, information related to payments or other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), to certain non-physician providers such as physician assistants and nurse practitioners, and to teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members.

Federal price reporting laws require manufacturers to calculate and report complex pricing metrics to government programs, where such reported prices may be used in the calculation of reimbursement and/or discounts on approved products.

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There are also analogous state and foreign laws and regulations, such as state and foreign anti-kickback, false claims, consumer protection and unfair competition laws which may apply to pharmaceutical business practices, including but not limited to, research, distribution, sales and marketing arrangements as well as submitting claims involving healthcare items or services reimbursed by any third-party payor, including commercial insurers;

state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government that

otherwise restricts payments that may be made to healthcare providers and other potential referral sources;

state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s

voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government that otherwise restricts payments that may be made to healthcare providers and other potential referral sources;

state laws that require drug manufacturers to file reports with states regarding pricing and marketing information, such as the tracking and reporting of gifts, compensation and other remuneration and items of value provided to healthcare professionals and entities;

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In addition, some third-party payors also require preapproval of coverage for new or innovative devices or drug therapies before they will reimburse healthcare providers who prescribe such therapies.

Payors may also impose step edits, prior authorization requirements, quantity limits, or preferential tiering for lower-cost or generic alternatives, which could delay or limit patient access to our products.

The cost of pharmaceuticals and devices continues to generate substantial governmental and third-party payor interest.

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Unlike Medicare Part A and B, Part D coverage is not standardized.

Part D prescription drug plan sponsors are not required to pay for all covered Part D drugs, and each drug plan can develop its

own drug formulary that identifies which drugs it will cover and at what tier or level.

However, Part D prescription drug formularies must include drugs within each therapeutic category and class of covered Part D drugs, though not necessarily all the drugs in each category or class.

Part D prescription drug plan sponsors are not required to pay for all covered Part D drugs, and each drug plan can develop its own drug formulary that identifies which drugs it will cover and at what tier or level.

However, Part D prescription drug formularies must

include drugs within each therapeutic category and class of covered Part D drugs, though not necessarily all the drugs in each category or class.

Any formulary used by a Part D prescription drug plan must be developed and reviewed by a pharmacy and therapeutic committee.

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• an increase in the rebates a manufacturer must pay under the Medicaid Drug Rebate Program to 23.1% and 13% of the average manufacturer price for branded and generic drugs, respectively;

● a Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% (later amended to 70%) point-of-sale discounts to negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D;

• a Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% (later amended to 70%) point-of-sale discounts to negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D, a program that has since been eliminated by the Inflation Reduction Act of 2022;

• extension of manufacturers’ Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations;

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• a requirement to annually report drug samples that manufacturers and distributors provide to physicians;

● establishment of a Center for Medicare Innovation at CMS to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug spending.

• establishment of a Center for Medicare and Medicaid Innovation at CMS to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug spending.

The ACA has been subject to challenges in the courts.

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The American Rescue Plan Act of 2021 eliminated the statutory Medicaid drug rebate cap, previously set at 100% of a drug’s average manufacturer price, for single source and innovator multiple source drugs, effective January 1, 2024.

Removal of the drug rebate cap may result in paying rebate payments to Medicaid that are higher than the sale price of the drug.

As a result, manufacturers may be required to pay Medicaid rebates that exceed the sales price of a drug, which could have a material adverse effect on our results of operations.

The Inflation Reduction Act of 2022 (“IRA”) contains substantial drug pricing reforms, including the establishment of a drug price negotiation program within the U.S.

Department of Health and Human Services that would require manufacturers to charge a negotiated “maximum fair price” for certain selected drugs or pay an excise tax for noncompliance.

Another component of the IRA includes the establishment of rebate payment requirements on Medicare Part D drugs which penalize price increases that outpace inflation.

Another component of the IRA includes the establishment of rebate payment requirements on Medicare

Part D drugs which penalize price increases that outpace inflation.

The IRA also redesigned Medicare Part D to reallocate cost across the various stakeholders:

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Certain aspects of the Part D redesign took effect in 2024 which ultimately shifts some liability from beneficiaries to the payors.

Starting on January 1, 2025, all remaining components of the Part D Redesign took effect, including, eliminating the previous coverage gap which has been replaced with greater exposure for manufacturers after the beneficiary pays their deductible.

All remaining components of the Part D Redesign took effect starting on January 1, 2025, including, eliminating the previous coverage gap which has been replaced with greater exposure for manufacturers after the beneficiary pays their deductible.

Additionally, the exemption previously applied on the low-income subsidy (“LIS”) population has been removed and increases manufacturer rebate exposure for that population.

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The effect of the IRA on our business and the pharmaceutical industry in general is not yet known.

In addition, the Trump Administration is likely to propose new regulations that reform healthcare delivery in the United States, including related to healthcare and drug costs and pharmacy benefit manager reform, among other areas, the effect of which on our business and the pharmaceutical industry in general is not yet known.

In addition, the One Big Beautiful Bill Act of 2025 imposed significant reductions in Medicaid funding, additional work requirements for certain Medicaid beneficiaries and more frequent eligibility redeterminations.

These changes are expected to place increased pressure on state Medicaid budgets and could reduce enrollment, utilization and reimbursement levels for prescription drugs, including our products, which could adversely affect our business.

The Trump Administration has issued several executive orders and supported regulatory initiatives in 2025 that could significantly affect prescription drug pricing.

On May 12, 2025, President Trump issued an executive order directing the Secretary of Health and Human Services to establish and communicate most-favored-nation (“MFN”) price targets and to pursue rulemaking to impose MFN-based pricing if sufficient progress is not achieved, while also supporting direct-to-patient sales models for manufacturers meeting such targets.

The executive order further contemplates additional actions, including potential modification of marketing approvals or use of drug importation authorities, if manufacturers do not comply.

In December 2025, CMS issued proposed rules that would create alternative payment models for Medicaid, Medicare Part B, and Medicare Part D that incorporate international reference-indexed MFN pricing principles, including proposed mandatory rebate models for certain single-source drugs under Medicare Part B and Part D.

These proposals are expected to face legal challenges, and their timing, scope and ultimate impact on manufacturer pricing and revenues remain uncertain.

Further, the White House in January 2026 released the “Great Healthcare Plan,” calling for Congress to codify the Trump Administration’s MFN drug-pricing deals (including to extend the results of recent voluntary negotiations following the May 2025 executive order), and also proposing measures that could affect pharmaceutical pricing and utilization dynamics more broadly, including expanding over-the-counter availability for certain verified-safe drugs and additional PBM/health insurance transparency and subsidy reforms.

Any such legislation or implementing regulations could affect our pricing flexibility, contracting strategy, distribution channels, and net revenues.

In addition, the Trump Administration is likely to propose additional new regulations that reform healthcare delivery in the United States, including related to healthcare and drug costs and pharmacy benefit manager reform, among other areas, the effect of which on our business and the pharmaceutical industry in general is not yet known.

Our Environmental, Social, and Governance (“ESG”) Initiatives

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As a reflection of this commitment, our annual Corporate Scorecard has included metrics relating to our performance relative to specific ESG initiatives.

In February 2025, we published our third annual ESG report on our corporate website highlighting our ESG accomplishments to date.

In February 2026, we published our fourth annual ESG report on our corporate website highlighting our ESG accomplishments to date.

The information contained in our ESG report is not a part of, nor is it incorporated by reference into, this Form 10-K.

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stock-based compensation includes restricted stock units for the entire organization.

The principal purposes of our equity and cash incentive plans are to attract, retain and reward personnel as they strive to increase stockholder value and

contribute to the success of our company by motivating such individuals to perform to the best of their abilities and achieve our objectives.

The principal purposes of our equity and cash incentive plans are to attract, retain and reward personnel as they strive to increase stockholder value and contribute to the success of our company by motivating such individuals to perform to the best of their abilities and achieve our objectives.

Employee Training and Development

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The following table lists the positions, names and ages of our executive officers as of February 26, 2026:

Vikram Karnani

Director, President and Chief Executive Officer

Colleen Tupper

Executive Vice President and Chief Financial Officer

Executive Vice President and Chief Commercial Officer

Shirley Kuhlmann

Executive Vice President, Chief Administrative Officer and General Counsel

Executive Vice President and Chief Medical Officer

Name Age Position(s)

Vikram Karnani 51 Director, President and Chief Executive Officer

Karnani was appointed as our President and Chief Executive Officer of Collegium Pharmaceutical in November 2024.

Prior to joining us, he served as Executive Vice President and President, Global Commercial Operations and Medical Affairs at Amgen Inc.

Colleen Tupper 50 Executive Vice President and Chief Financial Officer

Scott Dreyer 53 Executive Vice President and Chief Commercial Officer

David Dieter 62 Executive Vice President, General Counsel and Corporate Secretary

Thomas Smith 65 Executive Vice President and Chief Medical Officer

Vikram Karnani, Director, President and Chief Executive Officer.

Karnani has served as our President and Chief Executive Officer, and as director, since November 2024.

Karnani previously served as Executive Vice President and President, Global Commercial Operations and Medical Affairs at Amgen Inc.

(“Amgen”), a global biotechnology company.

6 unchanged sentences

Karnani was with Fresenius Kabi AG (“Fresenius Kabi”), a global health care company, where he served as Vice President of the therapeutics and cell therapy business from October 2011 to July 2014.

Karnani also held various positions in business development, corporate strategy and strategic marketing within Fenwal Inc., a global blood technology company that was acquired by Fresenius Kabi,from November 2008 to October 2011.

Karnani has a master’s degree from the Kellogg School of Management at Northwestern University, a master’s degree in electrical engineering from Case Western Reserve University and a bachelor of science degree in electrical engineering from University of Bombay, India.

17 unchanged sentences

Dreyer joined us in January 2018 as Senior Vice President of Sales, Marketing, Commercial Capabilities and Training.

He has over 25 years of commercial experience

across sales, marketing, commercial operations and strategic planning, all within the biopharma industry.

He has over 25 years of commercial experience across sales, marketing, commercial operations and strategic planning, all within the biopharma industry.

Most recently, Mr.

7 unchanged sentences

Director of Strategic Planning and Director of Cardiovascular Marketing.

Dreyer received a B.S.

Dreyer received his B.S.

in Biology from Messiah College.

Shirley Kuhlmann, Executive Vice President, Chief Administrative Officer and General Counsel.

Kuhlmann joined Collegium Pharmaceutical in March 2018 as Executive Vice President, General Counsel and Secretary and has also served as Chief Administrative Officer since March 2022.

Prior to joining Collegium, Ms.

Kuhlmann was an attorney in the Health Sciences Group of Pepper Hamilton LLP, a law firm headquartered in Philadelphia, Pennsylvania.

Kuhlmann began her career at Pepper Hamilton in 2007 as an Associate and was elected a Partner of the firm in 2016.

While with Pepper Hamilton, she advised private and public companies on a range of transactional matters, including securities offerings, mergers and acquisitions and other financing transactions.

Kuhlmann received a B.A.

in Economics and Political Science from Columbia University and a J.D.

from the Emory University School of Law.

David Dieter, Executive Vice President, General Counsel and Corporate Secretary.

Dieter has served as our Executive Vice President, General Counsel and Corporate Secretary since March 2025.

Dieter previously served as an independent legal advisor from October 2024 until February 2025 within the biopharma industry.

Prior to this, Mr.

Dieter served as Vice President, Legal at Horizon Therapeutics USA, Inc.

(“Horizon USA”) (which was acquired by Amgen in October 2023) where he managed internal and external legal counsel and served as an advisor to leadership across business functions on corporate and commercial matters, as well as international expansion, from October 2021 until February 2024, after which time he was not employed until October 2024.

Dieter was previously Associate General Counsel at Horizon USA, where he also assisted with Horizon USA’s business development transactions, from January 2017 until October 2021.

Before Horizon USA, David held several leadership roles at Takeda, including Vice President, Government Affairs and Associate General Counsel for Commercial Law.

Earlier in his career, Mr.

Dieter was a Partner at Freeborn & Peters, a mid-sized, full-service law firm which has since merged with Smith Gambrell Russell, and an Associate at Perkins Coie, a global law firm.

Dieter received a B.A.

in Economics from the University of Tennessee, Knoxville and a J.D.

from the University of Illinois College of Law, Champaign.

Thomas Smith, M.D., Executive Vice President and Chief Medical Officer.

Smith has served as our Chief Medical Officer since March 2022 following the acquisition of BDSI.

Smith has more than 25 years of experience in a variety of leadership roles at various major pharmaceutical companies, including serving as the Chief Medical Officer for BDSI from July 2018 to March 2022, Charleston Laboratories from January 2017 to July 2018, Ameritox and Mallinckrodt Pharmaceuticals.

Prior to these, Dr.

Smith has served as our Executive Vice President and Chief Medical Officer since March 2022 following the acquisition of BDSI.

Smith has more than 25 years of experience in a variety of leadership roles at various major pharmaceutical companies, including serving as the Chief Medical Officer for BDSI from July 2018 until March 2022, Charleston Laboratories from January 2017 to July 2018, Ameritox and Mallinckrodt Pharmaceuticals.

Prior to these roles, Dr.

Smith served in scientific, medical and clinical leadership roles at Abbott Laboratories, Teva Pharmaceuticals and Kendle International.

15 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business