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What changed in COLLEGIUM PHARMACEUTICAL, INC's 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of COLLEGIUM PHARMACEUTICAL, INC's 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+553 added−388 removedSource: 10-K (2026-02-26) vs 10-K (2025-02-27)

Top changes in COLLEGIUM PHARMACEUTICAL, INC's 2025 10-K

553 paragraphs added · 388 removed · 351 edited across 7 sections

Item 1. Business

Business — how the company describes what it does

134 edited+60 added−13 removed113 unchanged
Biggest changeFailure to meet FDA requirements for approval would also result in a medication not being approved for marketing. ​ The process of developing a pharmaceutical product and obtaining FDA approval to market the medication in the United States typically involves: ​ ● completion of preclinical laboratory and animal testing and formulation studies in compliance with the FDA’s good laboratory practices (“GLP”) and regulations; ● submission to the FDA of an Investigational New Drug (“IND”) application for human clinical testing, which becomes effective 30 days after submission and, if not placed on clinical hold, before human clinical trials may begin in the United States; ● approval by an independent institutional review board, at each clinical trial site before each trial may be initiated; ● performance of adequate and well - controlled human clinical trials in accordance with current good clinical practices (“GCP”) and FDA regulations to establish the safety and effectiveness of the proposed drug product for each indication for which FDA approval is sought; ● 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; 9 ​ ● submission to the FDA of a NDA or, in the case of a generic drug, an abbreviated NDA (“ANDA”); ● satisfactory completion of a review by an FDA advisory committee, if convened; and ● FDA review and approval of the NDA or ANDA. ​ Satisfaction of FDA pre-market approval requirements typically takes many years and the actual time required may vary substantially based upon the application type, complexity, and novelty of the product or disease. ​ Preclinical tests include laboratory evaluation of product chemistry, formulation, stability and toxicity, as well as animal studies to assess the characteristics and potential safety and efficacy of the product candidate.
Biggest changeThe process of developing a pharmaceutical product and obtaining FDA approval to market the medication in the United States typically involves: • completion of preclinical laboratory and animal testing and formulation studies in compliance with the FDA’s good laboratory practices (“GLP”) and regulations; • submission to the FDA of an Investigational New Drug (“IND”) application for human clinical testing, which becomes effective 30 days after submission and, if not placed on clinical hold, before human clinical trials may begin in the United States; • approval by an independent institutional review board, at each clinical trial site before each trial may be initiated; • performance of adequate and well-controlled human clinical trials in accordance with current good clinical practices (“GCP”) and FDA regulations to establish the safety and effectiveness of the proposed drug product for each indication for which FDA approval is sought; • 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 ANDA; • satisfactory completion of a review by an FDA advisory committee, if convened; and • FDA review and approval of the NDA or ANDA.
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. Additionally, the exemption previously applied on the low-income subsidy (“LIS”) population has been removed and increases manufacturer rebate exposure for that population.
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.
No ANDA application will receive final approval before any applicable non-patent exclusivity listed in the Orange Book for the referenced product has expired. ​ 14 ​ Section 505(b)(2) NDAs ​ A Section 505(b)(2) NDA is a special type of NDA often used by applicants seeking approval for new or improved formulations or new uses of previously approved active moieties.
No ANDA application will receive final approval before any applicable non-patent exclusivity listed in the Orange Book for the referenced product has expired. Section 505(b)(2) NDAs A Section 505(b)(2) NDA is a special type of NDA often used by applicants seeking approval for new or improved formulations or new uses of previously approved active moieties.
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 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.
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 3 ​ 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. market.
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. market.
The SEC also maintains a website, at www.sec.gov, that contains reports, proxy and information statements and other information regarding us and other issuers that file electronically. The information contained on, or that can be accessed through, our website is not a part of or incorporated by reference in this Form 10-K. ​ ​ ​ 22 ​
The SEC also maintains a website, at www.sec.gov, that contains reports, proxy and information statements and other information regarding us and other issuers that file electronically. The information contained on, or that can be accessed through, our website is not a part of or incorporated by reference in this Form 10-K.
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. Belbuca is classified as a Schedule III controlled substance, meaning it has a moderate to low potential for abuse.
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.
Moreover, even if the applicant believes it has addressed the deficiencies, it is possible that approval may not ultimately be obtained. ​ 11 ​ Where a sponsor wishes to expand the originally approved prescribing information, such as by adding a new indication, it must submit and obtain approval of a sNDA.
Moreover, even if the applicant believes it has addressed the deficiencies, it is possible that approval may not ultimately be obtained. Where a sponsor wishes to expand the originally approved prescribing information, such as by adding a new indication, it must submit and obtain approval of a sNDA.
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 21 ​ across sales, marketing, commercial operations and strategic planning, all within the biopharma industry. Most recently, Mr. Dreyer was Senior Vice President, Marketing and Commercial Operations for The Medicines Company.
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. Most recently, Mr. Dreyer was Senior Vice President, Marketing and Commercial Operations for The Medicines Company.
Violations of the AKS can 16 ​ 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.
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.
Part D prescription drug plan sponsors are not required to pay for all covered Part D drugs, and each drug plan can develop its 18 ​ own drug formulary that identifies which drugs it will cover and at what tier or level.
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.
Belbuca laminate (i.e., bulk product) is produced by Adhesives Research in Glen Rock, Pennsylvania and LTS Therapy Systems (formerly Tapemark) in St. Paul, Minnesota. Belbuca laminate is then sent to either LTS Therapy Systems (formerly Tapemark) in St.
Belbuca laminate (i.e., bulk product) is produced by Adhesives Research in Glen Rock, Pennsylvania and LTS Therapy Systems (formerly Tapemark) in St. Paul, Minnesota. Belbuca laminate is then sent to LTS Therapy Systems (formerly Tapemark) in St.
Other jurisdictions may enact similar or novel measures intended to reduce or constrain the growth of pharmaceutical spending or otherwise impose policy measures (either opioid-specific or applicable to the pharmaceutical industry as a whole) that could increase our operating costs associated with compliance. ​ 6 ​ Manufacturing of Our Products ​ Overview ​ Jornay is manufactured pursuant to supply agreements with third-party manufacturers.
Other jurisdictions may enact similar or novel measures intended to reduce or constrain the growth of pharmaceutical spending or otherwise impose policy measures (either opioid-specific or applicable to the pharmaceutical industry as a whole) that could increase our operating costs associated with compliance. Manufacturing of Our Products Overview Jornay PM is manufactured pursuant to supply agreements with third-party manufacturers.
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.
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.
As with traditional NDAs, a Section 505(b)(2) NDA may be eligible for three-year marketing exclusivity, assuming the NDA includes reports of new clinical trials (other than bioavailability clinical trials) essential to the approval of the NDA. For further detail regarding our litigation with Purdue regarding our Section 505(b)(2) NDA for Xtampza ER, refer to “Item 3.
As with traditional NDAs, a Section 505(b)(2) NDA may be eligible for three-year marketing exclusivity, assuming the NDA includes reports of new clinical trials (other than bioavailability clinical trials) essential to the approval of the NDA. For further detail regarding our litigation with Purdue regarding our Section 505(b)(2) NDA for Xtampza ER, refer to “Item 3. Legal Proceedings”.
Legal Proceedings”. ​ DEA and Opioid Regulation ​ Several of our products are regulated as “controlled substances” as defined in the Controlled Substances Act (“CSA”), which establishes registration, security, recordkeeping, reporting, storage, distribution, importation, exportation, and other requirements administered by the DEA. ​ The DEA regulates controlled substances as Schedule I, II, III, IV or V substances.
DEA and Opioid Regulation Several of our products are regulated as “controlled substances” as defined in the Controlled Substances Act (“CSA”), which establishes registration, security, recordkeeping, reporting, storage, distribution, importation, exportation, and other requirements administered by the DEA. The DEA regulates controlled substances as Schedule I, II, III, IV or V substances.
Among the provisions of the ACA of importance to the pharmaceutical and biotechnology industry are the following: ​ ● an annual, non-deductible fee on any entity that manufactures or imports certain branded prescription drugs and biologic agents, apportioned among these entities according to their market share in certain government healthcare programs; ● 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; ● extension of manufacturers’ Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations; ● expansion of eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to additional individuals and by adding new mandatory eligibility categories for certain individuals with income at or below 133% of the Federal Poverty Level, thereby potentially increasing manufacturers’ Medicaid rebate liability; ● expansion of the entities eligible for discounts under the Public Health Service pharmaceutical pricing program; ● a licensure framework for follow - on biologic products; ● a Patient - Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research; ● a requirement to annually report drug samples that manufacturers and distributors provide to physicians; and ● 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. ​ The ACA has been subject to challenges in the courts.
Among the provisions of the ACA of importance to the pharmaceutical and biotechnology industry are the following: • an annual, non-deductible fee on any entity that manufactures or imports certain branded prescription drugs and biologic agents, apportioned among these entities according to their market share in certain government healthcare programs; • 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 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; • expansion of eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to additional individuals and by adding new mandatory eligibility categories for certain individuals with income at or below 133% of the Federal Poverty Level, thereby potentially increasing manufacturers’ Medicaid rebate liability; • expansion of the entities eligible for discounts under the Public Health Service pharmaceutical pricing program; • a licensure framework for follow-on biologic products; • a Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research; • a requirement to annually report drug samples that manufacturers and distributors provide to physicians; and • 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.
Smith earned his M.D. from the Indiana University School of Medicine and a B.S. from Purdue University. ​ Our Corporate Information ​ We are headquartered in Stoughton, Massachusetts and our common stock trades on the NASDAQ Global Select Market (“NASDAQ”) under the trading symbol “COLL.” ​ Our predecessor was incorporated in Delaware in April 2002 under the name Collegium Pharmaceuticals, Inc. and in October 2003, our predecessor changed its name to Collegium Pharmaceutical, Inc.
Smith earned his M.D. from the Indiana University School of Medicine and a B.S. from Purdue University. 21 Table of Contents Our Corporate Information We are headquartered in Stoughton, Massachusetts and our common stock trades on the NASDAQ Global Select Market (“NASDAQ”) under the trading symbol “COLL.” Our predecessor was incorporated in Delaware in April 2002 under the name Collegium Pharmaceuticals, Inc. and in October 2003, our predecessor changed its name to Collegium Pharmaceutical, Inc.
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 15 ​ Jornay, oxycodone base for use in manufacturing Xtampza ER and tapentadol for use in manufacturing the Nucynta Products.
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.
Although their mechanisms of action differ, both amphetamine and methylphenidate have been shown to exhibit efficacy in the management of ADHD by increasing dopamine and norepinephrine availability in the corticostriatal systems that subserve behaviors related to cognition and executive function. ​ Pain, Pain Management, and Opioid Abuse in the United States ​ Acute and Chronic Pain ​ Pain can be classified along many different variables, including severity, duration and etiology.
Although their mechanisms of action differ, both amphetamine and methylphenidate have been shown to exhibit efficacy in the management of ADHD by increasing dopamine and norepinephrine availability in the corticostriatal systems that subserve behaviors related to cognition and executive function. 4 Table of Contents Pain, Pain Management, and Opioid Abuse in the United States Acute and Chronic Pain Pain can be classified along many different variables, including severity, duration and etiology.
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. ​ 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.
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.
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.
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 18 Table of Contents Part D drugs which penalize price increases that outpace inflation.
The information contained in our ESG report is not a part of, nor is it incorporated by reference into, this Form 10-K. ​ Human Capital Management ​ Collegium Culture and Employee Engagement ​ Our employees are foundational to our current and future success, and we believe that their engagement and commitment are among our most valuable assets.
The information contained in our ESG report is not a part of, nor is it incorporated by reference into, this Form 10-K. 19 Table of Contents Human Capital Management Collegium Culture and Employee Engagement Our employees are foundational to our current and future success, and we believe that their engagement and commitment are among our most valuable assets.
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.
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 extended until May 27, 2025.
Customers in the managed health care market include health maintenance organizations, nursing homes, hospitals, clinics, pharmacy benefit management companies and mail order customers. ​ Intellectual Property ​ The protection of patents, designs, trademarks and other proprietary rights that we own or license is critical to our success and competitive position.
Customers in the managed health care market include health maintenance organizations, nursing homes, hospitals, clinics, pharmacy benefit management companies and mail order customers. 7 Table of Contents Intellectual Property The protection of patents, designs, trademarks and other proprietary rights that we own or license is critical to our success and competitive position.
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.
The IRB also approves the informed consent form that must be 9 Table of Contents 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.
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 15 Table of Contents 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.
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.
However, Part D prescription drug formularies must 17 Table of Contents 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.
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.
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 PM competes with currently marketed, branded and generic methylphenidate products for the treatment of ADHD.
The final guidance also provides examples of product label claims that may be made based on the results of the corresponding studies and clinical trials. ​ After completion of the required clinical testing, an NDA is prepared and submitted to the FDA.
The final guidance also provides examples of product label claims that may be made based on the results of the corresponding studies and clinical trials. 10 Table of Contents After completion of the required clinical testing, an NDA is prepared and submitted to the FDA.
Further, all Schedule II drug prescriptions must be signed by a physician, presented to a pharmacist, and may not be refilled without a new prescription. ​ Annual DEA registration is required for any facility that manufactures, distributes, dispenses, imports, or exports any controlled substance. The registration is specific to the particular location, activity, and controlled substance schedule.
Further, all Schedule II drug prescriptions must be signed by a physician, presented to a pharmacist, and may not be refilled without a new prescription. 14 Table of Contents Annual DEA registration is required for any facility that manufactures, distributes, dispenses, imports, or exports any controlled substance. The registration is specific to the particular location, activity, and controlled substance schedule.
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. ​ Nucynta Products ​ The Nucynta Products are extended-release (“ER”) and immediate-release (“IR”) oral formulations of tapentadol, a Schedule II opioid.
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 ER. 3 Table of Contents Nucynta Products The Nucynta Products are extended-release (“ER”) and immediate-release (“IR”) oral formulations of tapentadol, a Schedule II opioid.
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 11 Table of Contents unrestricted grants funded by the opioid analgesic manufacturers.
Nucynta ER is currently manufactured by Patheon in Cincinnati, Ohio. Nucynta IR is manufactured by Halo Pharmaceutical, Inc. in Whippany, New Jersey. ​ Symproic is manufactured pursuant to supply agreements with third-party manufacturers.
The Nucynta Products are manufactured pursuant to supply agreements with third-party manufacturers. Nucynta ER is currently manufactured by Patheon in Cincinnati, Ohio. Nucynta IR is manufactured by Halo Pharmaceutical, Inc. in Whippany, New Jersey. Symproic is manufactured pursuant to supply agreements with third-party manufacturers.
On June 17, 2021, in an appeal from a lower court decision holding that the individual mandate under the Affordable Care Act is unconstitutional, the Supreme Court ruled that the plaintiffs lacked standing to challenge the law as they had not alleged personal injury traceable to the allegedly unlawful conduct.
The ACA has been subject to challenges in the courts. On June 17, 2021, in an appeal from a lower court decision holding that the individual mandate under the Affordable Care Act is unconstitutional, the Supreme Court ruled that the plaintiffs lacked standing to challenge the law as they had not alleged personal injury traceable to the allegedly unlawful conduct.
We provide all employees and their families with access to a variety of innovative, flexible, and convenient health and wellness programs. Employees As of December 31, 2024, we had a total of 357 full-time employees.
We provide all employees and their families with access to a variety of innovative, flexible, and convenient health and wellness programs. Employees As of December 31, 2025, we had a total of 423 full-time employees.
We have received trademark registration for Collegium Pharmaceutical, Inc., DETERx, and Xtampza ER in the United States, and acquired trademarks associated with the Nucynta Products in connection with our acquisition of assets and commercialization responsibilities of the Nucynta Products from Assertio Therapeutics, Inc.
We have received trademark registration for Collegium Pharmaceutical, Inc., DETERx, and Xtampza ER in the United States, and acquired trademarks associated with the Nucynta Products in connection with our acquisition of assets and commercialization responsibilities of the Nucynta Products from Assertio Therapeutics, Inc. (the “Nucynta Acquisition”); Belbuca and Symproic in connection with our acquisition of BioDelivery Sciences International, Inc.
Efforts to ensure that business arrangements comply with applicable healthcare laws involve substantial costs. It is possible that governmental and enforcement authorities will conclude that a pharmaceutical manufacturer’s business practices do not comply with current or future statutes, regulations or case law interpreting applicable fraud and abuse or other healthcare laws and regulations.
It is possible that governmental and enforcement authorities will conclude that a pharmaceutical manufacturer’s business practices do not comply with current or future statutes, regulations or case law interpreting applicable fraud and abuse or other healthcare laws and regulations.
In 2022, the number of reported deaths involving prescription opioids declined to 14,716, an improvement from 2020 levels. ​ Extended-release opioids may be especially attractive to people who abuse opioids because, if the extended-release mechanism can be defeated through tampering, many extended-release products quickly deliver a relatively large amount of active pharmaceutical ingredient (“API”) (i.e., an effect known as “dose dumping”).
In 2023, the number of reported deaths involving prescription opioids declined to 13,026, an improvement from 2017 levels. 5 Table of Contents Extended-release opioids may be especially attractive to people who abuse opioids because, if the extended-release mechanism can be defeated through tampering, many extended-release products quickly deliver a relatively large amount of active pharmaceutical ingredient (“API”) (i.e., an effect known as “dose dumping”).
If there is no listed patent in the Orange Book, there may not be a Paragraph IV certification, and, thus, no ANDA may be filed before the expiration of the exclusivity period.
An ANDA may be submitted one year before NCE exclusivity expires if a Paragraph IV certification is filed. If there is no listed patent in the Orange Book, there may not be a Paragraph IV certification, and, thus, no ANDA may be filed before the expiration of the exclusivity period.
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 17 ​ 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; state and local laws requiring the registration of pharmaceutical sales representatives; and state and foreign laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts. ​ Because of the breadth of these laws and the narrowness of the statutory exceptions and regulatory safe harbors available, it is possible that some of a pharmaceutical manufacturer’s business activities could be subject to challenge under one or more of such laws.
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 16 Table of Contents 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; state and local laws requiring the registration of pharmaceutical sales representatives; and state and foreign laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.
The requirement for a REMS can materially affect the potential market and profitability of a drug. ​ In July 2012, the FDA approved a class-wide REMS for extended-release and long-acting opioid products (Opioid Analgesic REMS). Extended-release formulations of oxycodone, morphine, hydrocodone and hydromorphone, for example, are required to have a REMS.
In July 2012, the FDA approved a class-wide REMS for extended-release and long-acting opioid products (Opioid Analgesic REMS). Extended-release formulations of oxycodone, morphine, hydrocodone and hydromorphone, for example, are required to have a REMS.
Discovery of previously unknown problems with a drug or the failure to comply with applicable FDA requirements can have negative consequences, including adverse publicity, judicial or administrative enforcement, untitled or warning letters from the FDA, mandated corrective advertising or communications with doctors, and civil or criminal penalties, among others. ​ The FDA held a meeting of the Anesthetic and Analgesic Drug Products Advisory Committee on April 19, 2023.
Discovery of previously unknown problems with a drug or the failure to comply with applicable FDA requirements can have negative consequences, including adverse publicity, judicial or administrative enforcement, untitled or warning letters from the FDA, mandated corrective advertising or communications with doctors, and civil or criminal penalties, among others.
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.
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 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.
Additionally, these confidentiality agreements require that our employees, consultants and advisors do not bring to us, or use without proper authorization, any third party’s proprietary technology. ​ Competition ​ Our industry is characterized by rapidly advancing technologies, intense competition, and a strong emphasis on proprietary products.
Additionally, these confidentiality agreements require that our employees, consultants and advisors do not bring to us, or use without proper authorization, any third party’s proprietary technology. Competition 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.
In 2023, 8.9 million, or 3.1% of people aged 12 and older, reported opioid misuse in the prior year as collected by the National Survey on Drug Use and Health sponsored by the Substance Abuse and Mental Health Services Administration (“SAMHSA”).
In 2024, 7.6 million, or 2.6% of people aged 12 and older, reported opioid misuse in the prior year as collected by the National Survey on Drug Use and Health sponsored by the Substance Abuse and Mental Health Services Administration (“SAMHSA”).
(the “Nucynta Acquisition”); Belbuca and 8 ​ Symproic in connection with our acquisition of BioDelivery Sciences Internations, Inc. (“BDSI”) (“the BDSI Acquisition”); and Jornay 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.
(“BDSI”) (“the BDSI Acquisition”); 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.
The IRA could have the effect of reducing the prices we can charge and reimbursement we receive for our products, thereby reducing our profitability, and could have a material adverse effect on our financial condition, results of operations and growth prospects.
The IRA could have the effect of reducing the prices we can charge and reimbursement we receive for our products, thereby reducing our profitability, and could have a material adverse effect on our financial condition, results of operations and growth prospects. The effect of the IRA on our business and the pharmaceutical industry in general is not yet known.
Symproic is manufactured by UPM Pharmaceuticals in Bristol, Tennessee and packaged by Sharp Packaging Solutions in Allentown, Pennsylvania. ​ Drug Substances ​ The API used to formulate the products in our portfolio and DEA drug scheduling are as follows: ​ ​ ​ ​ ​ ​ Product ​ API ​ DEA Drug Schedule Xtampza ER ​ Oxycodone ​ Schedule II Nucynta IR ​ Tapentadol ​ Schedule II Nucynta ER ​ Tapentadol ​ Schedule II Jornay ​ 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. federal law.
Drug Substances The API used to formulate the products in our portfolio and DEA drug scheduling are as follows: 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. federal law.
A sponsor may obtain a three-year period of exclusivity for a change to an approved drug, such as the addition of a new indication to the labeling or a new formulation, if the supplement includes reports of new clinical trials (other than bioavailability clinical trials) essential to the approval of the supplement. ​ An ANDA may be submitted one year before NCE exclusivity expires if a Paragraph IV certification is filed.
A sponsor may obtain a three-year period of exclusivity for a change to an approved drug, such as the addition of a new indication to the labeling or a new formulation, if the supplement includes reports of new clinical trials (other than bioavailability clinical trials) essential to the approval of the supplement.
Recognizing the role that opioid therapy continues to play in effective management of moderate to severe pain in appropriate patients, these groups are advocating for best practices that support appropriate opioid prescribing to help mitigate the risks of abuse, addiction and other adverse events associated with prescription opioids. ​ Prescription Opioid Abuse in the United States Prescription opioids of all kinds, including both immediate-release and extended-release formulations, are subject to manipulation, diversion, misuse, and abuse.
Recognizing the role that opioid therapy continues to play in effective management of moderate to severe pain in appropriate patients, these groups are advocating for best practices that support appropriate opioid prescribing to help mitigate the risks of abuse, addiction and other adverse events associated with prescription opioids.
Mr. 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. (“Amgen”), a global biotechnology company. Mr. Karnani joined Amgen in October 2023 through Amgen’s acquisition of Horizon Therapeutics plc (“Horizon”). Mr.
Mr. Karnani has served as our President and Chief Executive Officer, and as director, since November 2024. Mr. Karnani previously served as Executive Vice President and President, Global Commercial Operations and Medical Affairs at Amgen Inc. (“Amgen”), a global biotechnology company. Mr. Karnani joined Amgen in October 2023 through Amgen’s acquisition of Horizon Therapeutics plc (“Horizon”). Mr.
Some states, however, have applicable fraud and abuse laws that apply more broadly to include products or services reimbursed by private payors. ​ The federal Anti-Kickback Statute (“AKS”) (42 U.S.C. § 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.
The federal Anti-Kickback Statute (“AKS”) (42 U.S.C. § 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.
In addition, government entities and private litigants have asserted claims under state consumer protection statutes against pharmaceutical and medical device companies for alleged false or misleading statements in connection with the marketing, promotion and/or sale of pharmaceutical and medical device products, including state investigations and litigation by certain government entities regarding our marketing of opioid products. ​ The federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) created additional federal criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payor (e.g., public or private) and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false statements in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters.
The federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) created additional federal criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payor (e.g., public or private) and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false statements in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters.
The Federal Food, Drug, and Cosmetic Act and other federal and state statutes and regulations govern the research, development, testing, manufacture, storage, recordkeeping, approval, labeling, promotion and marketing, distribution, post-approval monitoring and reporting, sampling, and import and export of pharmaceutical products.
Government Regulation FDA Approval Process In the United States, pharmaceutical products are subject to extensive regulation by the FDA. The Federal Food, Drug, and Cosmetic Act and other federal and state statutes and regulations govern the research, development, testing, manufacture, storage, recordkeeping, approval, labeling, promotion and marketing, distribution, post-approval monitoring and reporting, sampling, and import and export of pharmaceutical products.
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. ​ Belbuca and Symproic are 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.
The proposed design of study 3033-11, the enriched enrollment randomized withdrawal design, was not supported. ​ From time to time, legislation is drafted, introduced, passed in Congress and signed into law that could significantly change the statutory provisions governing the approval, manufacturing, and marketing of products regulated by the FDA.
From time to time, legislation is drafted, introduced, passed in Congress and signed into law that could significantly change the statutory provisions governing the approval, manufacturing, and marketing of products regulated by the FDA.
In addition, the REMS must include a timetable for periodically assessing the strategy, at a minimum, at 18 months, three years, and seven years after the REMS approval.
In addition, the REMS must include a timetable for periodically assessing the strategy, at a minimum, at 18 months, three years, and seven years after the REMS approval. The requirement for a REMS can materially affect the potential market and profitability of a drug.
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.
These guidelines are grounded in patient-centered care and the 2022 update provides algorithms for determining the appropriateness of opioids for chronic pain, determining the initiation of opioids, and maintaining, tapering, discontinuing or switching from full agonist opioid treatment. ​ While much, if not most, of the state level efforts have focused primarily on increasing people’s access to substance abuse treatment and harm reduction measures, some initiatives more directly impact manufacturers and distributors of prescription opioid products; these laws include requirements that manufacturers fund statewide drug take-back programs or pay opioid-specific taxes or “impact fees” and laws that limit the amount of opioid products that a physician may prescribe.
While much, if not most, of the state level efforts have focused primarily on increasing people’s access to substance abuse treatment and harm reduction measures, some initiatives more directly impact manufacturers and distributors of prescription opioid products; these laws include requirements that manufacturers fund statewide drug take-back programs or pay opioid-specific taxes or “impact fees” and laws that limit the amount of opioid products that a physician may prescribe.
As a result, our operations and business could be adversely affected by current and future third-party payor policies as well as healthcare legislative reforms. ​ While we cannot predict whether any proposed cost-containment measures will be adopted or otherwise implemented in the future, the impact of changes in agency leadership, or whether the Trump Administration may propose additional regulatory reforms, these requirements or any announcement or adoption of such proposals could have a material adverse effect on our ability to obtain adequate prices for our products and any other products we may seek to commercialize, and to operate profitably. ​ Healthcare Reform ​ In the United States, there have been a number of legislative and regulatory changes to the healthcare system that could affect our future results of operations.
While we cannot predict whether any proposed cost-containment measures will be adopted or otherwise implemented in the future, the impact of changes in agency leadership, or whether the Trump Administration may propose additional regulatory reforms, these requirements or any announcement or adoption of such proposals could have a material adverse effect on our ability to obtain adequate prices for our products and any other products we may seek to commercialize, and to operate profitably.
Due to the controlled substances classification, the manufacturing, shipping, dispensing and storing of these products are subject to a high degree of regulation, as described in more detail under the caption “— Government Regulation — DEA and Opioid Regulation.” ​ We currently procure the API used in our products from a sole supplier or limited number of suppliers. ​ 7 ​ Marketing and Commercialization ​ We commercialize our products in the United States through two dedicated field sales forces, one focused on our pain portfolio and the other on ADHD.
Due to the controlled substances classification, the manufacturing, shipping, dispensing and storing of these products are subject to a high degree of regulation, as described in more detail under the caption “— Government Regulation — DEA and Opioid Regulation.” We currently procure the API used in our products from a sole supplier or limited number of suppliers.
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 ​ FDA Approval Process ​ In the United States, pharmaceutical products are subject to extensive regulation by the FDA.
We believe the key competitive factors that will affect the commercial success of our products include the 8 Table of Contents 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.
Prescription opioids are available in immediate-release formulations as well as in long-acting/extended-release formulations, which incorporate a time-release mechanism designed to deliver steady amounts of opioid, typically over 12 to 24 hours.
Prescription opioids are available in immediate-release formulations as well as in long-acting/extended-release formulations, which incorporate a time-release mechanism designed to deliver steady amounts of opioid, typically over 12 to 24 hours. Extended-release opioids are designed to offer more convenient dosing with a longer period of consistent blood levels of the active drug as compared to immediate-release formulations.
Federal criminal law at 18 U.S.C. § 1001, among other sections, prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services. ​ The civil False Claims Act and similar state laws impose liability on any person or entity who, among other things, knowingly presents, or causes to be presented, a false or fraudulent claim for payment by a federal healthcare program.
Federal criminal law at 18 U.S.C. § 1001, among other sections, prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services.
Exclusivity ​ Upon approval of an NDA for a new chemical entity (“NCE”), which is a drug that contains no active moiety that has been approved by the FDA in any other NDA, that drug receives five years of marketing exclusivity during which time the FDA cannot receive any ANDA seeking approval of a generic version of that drug or any Section 505(b)(2) NDA, discussed in more detail below, that relies on the FDA’s findings of safety and effectiveness regarding the NCE drug.
The filing of a patent infringement lawsuit within 45 days of the receipt of a Paragraph IV certification automatically prevents the FDA from approving the ANDA until the earlier of 30 months, expiration of the patent, settlement of the lawsuit, or a decision in the infringement case that is favorable to the ANDA applicant. 13 Table of Contents Exclusivity Upon approval of an NDA for a new chemical entity (“NCE”), which is a drug that contains no active moiety that has been approved by the FDA in any other NDA, that drug receives five years of marketing exclusivity during which time the FDA cannot receive any ANDA seeking approval of a generic version of that drug or any Section 505(b)(2) NDA, discussed in more detail below, that relies on the FDA’s findings of safety and effectiveness regarding the NCE drug.
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.
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.
Additionally, appropriate packaging must be selected and tested and stability studies must be conducted to demonstrate that the drug does not undergo unacceptable deterioration over its shelf life. ​ For opioid products designed to deter abuse, FDA guidance regarding studies and clinical trials dictates what types of studies should be conducted to demonstrate abuse-deterrence, how those studies and clinical trials will be evaluated, and what product labeling claims may be approved based on the results of those studies and clinical trials.
For opioid products designed to deter abuse, FDA guidance regarding studies and clinical trials dictates what types of studies should be conducted to demonstrate abuse-deterrence, how those studies and clinical trials will be evaluated, and what product labeling claims may be approved based on the results of those studies and clinical trials.
Third-party payors include governmental programs such as Medicare or Medicaid, private insurance plans and managed care plans. These third-party payors may deny coverage or reimbursement for a product or therapy in whole or in part if they determine that the product or therapy was not medically appropriate or necessary.
These third-party payors may deny coverage or reimbursement for a product or therapy in whole or in part if they determine that the product or therapy was not medically appropriate or necessary.
The Budget Control Act of 2011 and subsequent legislation has resulted in reductions to Medicare payments to providers of up to 2% per fiscal year, which will remain in effect through 2031 unless additional action is taken by Congress. ​ The American Taxpayer Relief Act of 2012 reduced Medicare payments to several providers and increased the statute of limitations period for the government to recover overpayments to providers from three to five years.
The Budget Control Act of 2011 and subsequent legislation has resulted in reductions to Medicare payments to providers of up to 2% per fiscal year, which will remain in effect through 2031 unless additional action is taken by Congress.
Moreover, while the Medicare Modernization Act applies only to drug benefits for Medicare beneficiaries, private payors often follow Medicare coverage policy and payment limitations in setting their own payment rates.
Moreover, while the Medicare Modernization Act applies only to drug benefits for Medicare beneficiaries, private payors often follow Medicare coverage policy and payment limitations in setting their own payment rates. Any reduction in payment that results from Medicare Part D may result in a similar reduction in payments from non-governmental payors.
A 505(b)(2) application that references a prior approval may seek approval for some or all of the referenced product’s labeled indications and/or for a different indication not included in the referenced product’s label. ​ To the extent that the Section 505(b)(2) applicant is relying on the FDA’s findings of safety and effectiveness for an already approved product, the applicant is required to certify to the FDA concerning any patents listed for the approved product in the Orange Book to the same extent that an ANDA applicant would.
To the extent that the Section 505(b)(2) applicant is relying on the FDA’s findings of safety and effectiveness for an already approved product, the applicant is required to certify to the FDA concerning any patents listed for the approved product in the Orange Book to the same extent that an ANDA applicant would.
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. ​ Distributions of any Schedule I or II controlled substance must also be accompanied by special order forms, with copies provided to the DEA. ​ The DEA also requires drug manufacturers to design and implement a system that identifies suspicious orders of controlled substances, such as those of unusual size, those that deviate substantially from a normal pattern and those of unusual frequency, prior to completion of the sale.
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. Distributions of any Schedule I or II controlled substance must also be accompanied by special order forms, with copies provided to the DEA.
This group provides authorization for whether a trial may move forward at designated check points based on access to certain data from the trial. ​ Concurrent with clinical trials, companies usually complete additional animal studies and also must develop additional information about the chemistry and physical characteristics of the drug as well as finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements.
Concurrent with clinical trials, companies usually complete additional animal studies and also must develop additional information about the chemistry and physical characteristics of the drug as well as finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements.
However, prescription levels in 2020 returned to levels similar to those seen in the year 2000, when 143.8 million prescriptions for opioids were written in the United States, including 11.4 million prescriptions for extended-release opioids and 132.4 million prescriptions for immediate-release opioids. ​ Increasingly, practitioners and regulators are focusing on multidisciplinary, multimodal approaches to pain management, including exercise, physical therapy and psychotherapy, and opioid and non-opioid medications.
However, prescription levels in 2020 returned to levels similar to those seen in the year 2000, when 143.8 million prescriptions for opioids were written in the United States, including 11.4 million prescriptions for extended-release opioids and 132.4 million prescriptions for immediate-release opioids.
Our Executive Officers ​ The following table lists the positions, names and ages of our executive officers as of February 27, 2025: ​ ​ ​ ​ ​ ​ Name ​ Age ​ Position(s) Vikram Karnani ​ 50 ​ Director, President and Chief Executive Officer Colleen Tupper ​ 49 ​ Executive Vice President and Chief Financial Officer Scott Dreyer ​ 52 ​ Executive Vice President and Chief Commercial Officer Shirley Kuhlmann ​ 41 ​ Executive Vice President, Chief Administrative Officer and General Counsel Thomas Smith ​ 64 ​ Executive Vice President and Chief Medical Officer ​ Vikram Karnani, Director, President and Chief Executive Officer.
Our Executive Officers The following table lists the positions, names and ages of our executive officers as of February 26, 2026: Name Age Position(s) Vikram Karnani 51 Director, President and Chief Executive Officer 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 20 Table of Contents Vikram Karnani, Director, President and Chief Executive Officer.
These wax-based microspheres are designed to resist particle size reduction and dose dumping when subjected to physical and chemical manipulation. ​ We are committed to ongoing monitoring and public dissemination of our real-world abuse and diversion data, regardless of the results. The two main sources of real-world abuse, misuse, and diversion data are RADARS® and Inflexxion, an IBH Company.
We are committed to ongoing monitoring and public dissemination of our real-world abuse and diversion data, regardless of the results. The two main sources of real-world abuse, misuse, and diversion data are RADARS® and Inflexxion, an IBH Company.
The conduct of the preclinical tests must comply with federal regulations and requirements, including GLPs. The results of preclinical testing are submitted to the FDA as part of an IND application along with other information, including information about product chemistry, manufacturing and controls, and a proposed clinical trial protocol.
The results of preclinical testing are submitted to the FDA as part of an IND application along with other information, including information about product chemistry, manufacturing and controls, and a proposed clinical trial protocol. Long-term preclinical tests, such as animal tests of reproductive toxicity and carcinogenicity, may continue after the IND application is submitted.
This could subject a company to a range of penalties that could have a significant commercial impact, including civil and criminal fines and agreements that materially restrict the manner in which a company promotes or distributes drug products. ​ Post-Approval Requirements ​ Once an NDA is approved, a product will be subject to pervasive and continuing regulation by the FDA, including, among other things, requirements relating to drug listing and establishment registration, recordkeeping, periodic reporting, product sampling and distribution, adverse event reporting and advertising, marketing and promotion restrictions.
Post-Approval Requirements Once an NDA is approved, a product will be subject to pervasive and continuing regulation by the FDA, including, among other things, requirements relating to drug listing and establishment registration, recordkeeping, periodic reporting, product sampling and distribution, adverse event reporting and advertising, marketing and promotion restrictions.
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.
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 PM.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeNet prices for drugs may be reduced by mandatory discounts or rebates required by government healthcare programs or private payors and by any future relaxation of laws that presently restrict imports of drugs from policy and payment limitations in setting their own reimbursement policies. ​ Our inability to expand and maintain coverage and profitable reimbursement rates from both government-funded and private payors for our products could have a material adverse effect on our operating results, our ability to raise capital needed to continue to commercialize our products and our overall financial condition. 32 ​ ​ The Affordable Care Act and any changes in healthcare law may increase the difficulty and cost for us to continue to commercialize our products and affect the prices we may obtain. ​ The United States and many foreign jurisdictions have enacted or proposed legislative and regulatory changes affecting the healthcare system that may affect our ability to profitably sell our products, including implementing cost-containment programs to limit the growth of government-paid healthcare costs, including price controls, restrictions on reimbursement and requirements for substitution of generic products for branded prescription drugs. ​ The Affordable Care Act was intended to broaden access to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies against fraud and abuse, add transparency requirements for the healthcare and health insurance industries, impose new taxes and fees on the health industry and impose additional health policy reforms.
Biggest changeThe United States and many foreign jurisdictions have enacted or proposed legislative and regulatory changes affecting the healthcare system that may affect our ability to profitably sell our products, including implementing cost-containment programs to limit the growth of government-paid healthcare costs, including price controls, restrictions on reimbursement and requirements for substitution of generic products for branded prescription drugs.
You are encouraged to carefully review our full discussion of the material risk factors relevant to an investment in our business, which follows the brief bulleted list of our principal risk factors set forth below: ● Our ability to maintain profitability is dependent upon our ability to continue successfully commercializing our products and any products we may acquire in the future; ● We have substantial outstanding indebtedness, which may adversely affect our business, financial condition and results of operations; ● Adverse developments affecting the financial services industry could adversely affect our business, financial condition, or results of operations; ● If we cannot continue successfully commercializing our products and any products that we may acquire in the future, our business, financial condition and results of operations may be materially adversely affected and the price of our common stock may decline; ● Despite receiving approval by the FDA, additional data may emerge that could change the FDA’s position on the product labeling of any of our products, including our abuse-deterrent claims with respect to Xtampza ER, and our ability to market our products successfully may be adversely affected; ● Belbuca, Xtampza ER, and the Nucynta Products are subject to mandatory Risk Evaluation and Mitigation Strategy (“REMS”) programs, which could increase the cost, burden and liability associated with the commercialization of these products; ● Failure to comply with ongoing governmental regulations for marketing our products, and in particular any failure to promote Xtampza ER’s abuse deterrent labeling in compliance with FDA regulations, could delay or inhibit our ability to generate revenues from their sale and could also expose us to claims or other sanctions; ● Unfavorable outcomes in intellectual property litigation could be costly and potentially limit our ability to commercialize our products; ● If we are unable to obtain or maintain intellectual property rights for our technologies, products or any products we may acquire, we may lose valuable assets or be unable to compete effectively in our market; ● We have been, and may continue to be, forced to litigate to enforce or defend our intellectual property, which could be expensive, time consuming and unsuccessful, and result in the loss of valuable assets; ● Obtaining and maintaining our patent protection depends on compliance with various procedural, document submissions, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements; ● If we are unable to utilize our own sales and marketing capabilities successfully or enter into strategic alliances with marketing collaborators, we may not continue to be successful in commercializing our products and may be unable to generate sufficient product revenue; ● If the medical community, patients, and healthcare payors do not accept and use our products, we will not achieve sufficient product revenues and our business will suffer; ● Our products contain controlled substances, the manufacture, use, sale, importation, exportation and distribution of which are subject to regulation by state and federal law enforcement and other regulatory agencies; ● Current and future legislation may increase the difficulty and cost for us to continue to commercialize our products and may reduce the prices we are able to obtain for our products; ● Our products may become subject to unfavorable pricing regulations or third-party coverage and reimbursement policies, which could have a material adverse effect on our business.
You are encouraged to carefully review our full discussion of the material risk factors relevant to an investment in our business, which follows the brief bulleted list of our principal risk factors set forth below: • Our ability to maintain profitability is dependent upon our ability to continue successfully commercializing our products and any products we may acquire in the future; • We have substantial outstanding indebtedness, which may adversely affect our business, financial condition and results of operations; • Adverse developments affecting the financial services industry could adversely affect our business, financial condition, or results of operations; • If we cannot continue successfully commercializing our products and any products that we may acquire in the future, our business, financial condition and results of operations may be materially adversely affected and the price of our common stock may decline; • Despite receiving approval by the FDA, additional data may emerge that could change the FDA’s position on the product labeling of any of our products, including our abuse-deterrent claims with respect to Xtampza ER, and our ability to market our products successfully may be adversely affected; • Belbuca, Xtampza ER, and the Nucynta Products are subject to mandatory Risk Evaluation and Mitigation Strategy (“REMS”) programs, which could increase the cost, burden and liability associated with the commercialization of these products; • Failure to comply with ongoing governmental regulations for marketing our products, and in particular any failure to promote Xtampza ER’s abuse deterrent labeling in compliance with FDA regulations, could delay or inhibit our ability to generate revenues from their sale and could also expose us to claims or other sanctions; 22 Table of Contents • Unfavorable outcomes in intellectual property litigation could be costly and potentially limit our ability to commercialize our products; • If we are unable to obtain or maintain intellectual property rights for our technologies, products or any products we may acquire, we may lose valuable assets or be unable to compete effectively in our market; • We have been, and may continue to be, forced to litigate to enforce or defend our intellectual property, which could be expensive, time consuming and unsuccessful, and result in the loss of valuable assets; • Obtaining and maintaining our patent protection depends on compliance with various procedural, document submissions, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements; • If we are unable to utilize our own sales and marketing capabilities successfully or enter into strategic alliances with marketing collaborators, we may not continue to be successful in commercializing our products and may be unable to generate sufficient product revenue; • If the medical community, patients, and healthcare payors do not accept and use our products, we will not achieve sufficient product revenues and our business will suffer; • Our products contain controlled substances, the manufacture, use, sale, importation, exportation and distribution of which are subject to regulation by state and federal law enforcement and other regulatory agencies; • Current and future legislation may increase the difficulty and cost for us to continue to commercialize our products and may reduce the prices we are able to obtain for our products; • Our products may become subject to unfavorable pricing regulations or third-party coverage and reimbursement policies, which could have a material adverse effect on our business.
Such failure could also be the basis for the FDA to issue a warning or untitled letter, withdraw approvals for products previously granted to us, or take other regulatory or legal action, including recall or seizure, total or partial suspension of production, refusal to approve 35 ​ pending applications or supplemental applications, detention of product, refusal to permit the import or export of products, injunction, imposing civil penalties or pursuing criminal prosecution.
Such failure could also be the basis for the FDA to issue a warning or untitled letter, withdraw approvals for products previously granted to us, or take other regulatory or legal action, including recall or seizure, total or partial suspension of production, refusal to approve pending applications or supplemental applications, detention of product, refusal to permit the import or export of products, injunction, imposing civil penalties or pursuing criminal prosecution.
Supreme Court’s July 2024 decision to overturn prior established case law giving deference to regulatory agencies’ interpretations of ambiguous statutory language has introduced uncertainty regarding the extent to which FDA’s regulations, policies, and decisions may become subject to 31 ​ increasing legal challenges, delays, and/or changes. In addition, increased scrutiny by the U.S.
Supreme Court’s July 2024 decision to overturn prior established case law giving deference to regulatory agencies’ interpretations of ambiguous statutory language has introduced uncertainty regarding the extent to which FDA’s regulations, policies, and decisions may become subject to increasing legal challenges, delays, and/or changes. In addition, increased scrutiny by the U.S.
Our Systems, along with those of the third parties whom we rely on to process confidential and sensitive data in a variety of contexts, are potentially vulnerable to a variety of evolving threats that may expose this data 37 ​ to unauthorized persons or otherwise compromise its integrity.
Our Systems, along with those of the third parties whom we rely on to process confidential and sensitive data in a variety of contexts, are potentially vulnerable to a variety of evolving threats that may expose this data to unauthorized persons or otherwise compromise its integrity.
If we are unable to continue to grow and maintain adequate sales, marketing and distribution capabilities, whether independently or with third parties, including with respect to our acquisition of Jornay, we may not be able to generate sufficient product revenue and may not remain profitable.
If we are unable to continue to grow and maintain adequate sales, marketing and distribution capabilities, whether independently or with third parties, including with respect to our acquisition of Jornay PM, we may not be able to generate sufficient product revenue and may not remain profitable.
In connection with the Ironshore Acquisition, we acquired the sales force supporting Jornay and we cannot guarantee that we will be able to successfully grow the Jornay sales infrastructure, while continuing to support and maintain our existing sales organization.
In connection with the Ironshore Acquisition, we acquired the sales force supporting Jornay PM and we cannot guarantee that we will be able to successfully grow the Jornay PM sales infrastructure, while continuing to support and maintain our existing sales organization.
These generic equivalents would be significantly less costly than ours to bring to market and companies that 33 ​ produce generic equivalents are generally able to offer their products at lower prices.
These generic equivalents would be significantly less costly than ours to bring to market and companies that produce generic equivalents are generally able to offer their products at lower prices.
Our existing and future levels of indebtedness could have significant negative consequences for our security holders and our business, results of operations and financial condition by, and among other things: ​ ● requiring the dedication of a substantial portion of our cash flows from operations to service our indebtedness, which will reduce the amount of cash available for operations, working capital, capital expenditures, expansion, acquisitions or general corporate or other purposes; ● limiting our ability to obtain additional financing; ● limiting our flexibility to plan for, or react to, changes in our business; ● exposing us to the risk of increased interest rates as certain of our borrowings, including the 2024 Term Loan, are at variable rates of interest; ● diluting the interests of our existing shareholders as a result of issuing shares of our common stock upon conversion of the 2029 Convertible Notes; ● placing us at a possible competitive disadvantage with competitors that are less leveraged than we are or have better access to capital; and ● increasing our vulnerability to downturns in our business, our industry or the economy in general. ​ Holders of our 2029 Convertible Notes, subject to a limited exception described in the notes, may require us to repurchase their notes following a fundamental change at a cash repurchase price generally equal to the principal amount of the notes to be repurchased, plus accrued and unpaid interest, if any.
Our existing and future levels of indebtedness could have significant negative consequences for our security holders and our business, results of operations and financial condition by, and among other things: • requiring the dedication of a substantial portion of our cash flows from operations to service our indebtedness, which will reduce the amount of cash available for operations, working capital, capital expenditures, expansion, acquisitions or general corporate or other purposes; • limiting our ability to obtain additional financing; • limiting our flexibility to plan for, or react to, changes in our business; • exposing us to the risk of increased interest rates as certain of our borrowings, including the 2025 Term Loan, are at variable rates of interest; • diluting the interests of our existing shareholders as a result of issuing shares of our common stock upon conversion of the 2029 Convertible Notes; • placing us at a possible competitive disadvantage with competitors that are less leveraged than we are or have better access to capital; and • increasing our vulnerability to downturns in our business, our industry or the economy in general. 24 Table of Contents Holders of our 2029 Convertible Notes, subject to a limited exception described in the notes, may require us to repurchase their notes following a fundamental change at a cash repurchase price generally equal to the principal amount of the notes to be repurchased, plus accrued and unpaid interest, if any.
Such pricing regulations may address the 23 ​ rebates that manufacturers offer to pharmaceutical benefit managers, or the discounts that manufacturers provide others within the pharmaceutical distribution chain; ● Social issues around the abuse of opioids, including law enforcement concerns over diversion of opioids and regulatory and enforcement efforts to combat abuse, could decrease the potential market for our opioid products and may adversely impact external investor perceptions of our business; ● If the FDA or other applicable regulatory authorities approve generic products with abuse deterrent claims that compete with our opioid products, our sales could decline; ● If the third-party manufacturers of our products fail to devote sufficient time and resources to these products, or their performance is substandard, and/or we encounter challenges with our dedicated manufacturing suite at our third-party manufacturer’s site for the manufacturing of Xtampza ER, our costs may be higher than expected and could have a material adverse effect on our business; ● Because we currently rely on a sole supplier or limited number of suppliers to manufacture the active pharmaceutical ingredient of our products, any production problems with any of these suppliers could have a material adverse effect on us; ● We depend on wholesale pharmaceutical distributors for retail distribution of our products; if we lose any of our significant wholesale pharmaceutical distributors or their distribution network is disrupted, our financial condition and results of operations may be adversely affected; ● Our products could be subject to post-marketing requirements, which requirements may, in some cases, not be capable of timely or satisfactory completion without participation in consortia over which we have limited control; ● Our business may be adversely affected by certain events or circumstances outside our control, including macroeconomic conditions and geopolitical turmoil; ● Litigation or regulatory action regarding opioid medications could negatively affect our business; ● We face substantial competition from other biotechnology and pharmaceutical companies, which may result in others discovering, developing or commercializing products more successfully than we do; ● Commercial sales of our products may expose us to expensive product liability claims, and we may not be able to maintain product liability insurance on reasonable terms or at all; ● Our relationships with customers and payors are subject to applicable anti-kickback, fraud and abuse, transparency, and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, exclusion from government healthcare programs, contractual damages, reputational harm, administrative burdens, and diminished profits and future earnings; and ● The price of our common stock may be volatile and you may lose all or part of your investment. ​ Risks Related to Our Financial Position and Capital Needs Our ability to maintain profitability is dependent upon our ability to continue successfully commercializing our products and any products that we may acquire in the future.
Such pricing regulations may address the rebates that manufacturers offer to pharmaceutical benefit managers, or the discounts that manufacturers provide others within the pharmaceutical distribution chain; • Social issues around the abuse of opioids, including law enforcement concerns over diversion of opioids and regulatory and enforcement efforts to combat abuse, could decrease the potential market for our opioid products and may adversely impact external investor perceptions of our business; • If the FDA or other applicable regulatory authorities approve generic products with claims that compete with our opioid products, our sales could decline; • If the third-party manufacturers of our products fail to devote sufficient time and resources to these products, or their performance is substandard, and/or we encounter challenges with our dedicated manufacturing suite at our third-party manufacturer’s site for the manufacturing of Xtampza ER, our costs may be higher than expected and could have a material adverse effect on our business; • Because we currently rely on a sole supplier or limited number of suppliers to manufacture the active pharmaceutical ingredient of our products, any production problems with any of these suppliers could have a material adverse effect on us; • We depend on wholesale pharmaceutical distributors for retail distribution of our products; if we lose any of our significant wholesale pharmaceutical distributors or their distribution network is disrupted, our financial condition and results of operations may be adversely affected; • Our products could be subject to post-marketing requirements, which requirements may, in some cases, not be capable of timely or satisfactory completion without participation in consortia over which we have limited control; • We may not realize all the anticipated benefits from our future acquisitions, and we may be unable to successfully integrate future acquisitions; • Our business may be adversely affected by certain events or circumstances outside our control, including macroeconomic conditions and geopolitical turmoil; • Litigation or regulatory action regarding opioid medications could negatively affect our business; • We face substantial competition from other biotechnology and pharmaceutical companies, which may result in others discovering, developing or commercializing products more successfully than we do; • Commercial sales of our products may expose us to expensive product liability claims, and we may not be able to maintain product liability insurance on reasonable terms or at all; • Our relationships with customers and payors are subject to applicable anti-kickback, fraud and abuse, transparency, and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, exclusion from government healthcare programs, contractual damages, reputational harm, administrative burdens, and diminished profits and future earnings; and • The price of our common stock may be volatile and you may lose all or part of your investment. 23 Table of Contents Risks Related to Our Financial Position and Capital Needs Our ability to maintain profitability is dependent upon our ability to continue successfully commercializing our products and any products that we may acquire in the future.
The 2024-2025 Repurchase Program permits us to effect repurchases through a variety of methods, including open-market purchases (including pursuant to a trading plan adopted in accordance with Rule 10b5-1 of the Exchange Act), privately negotiated transactions, or otherwise in compliance with Rule 10b-18 of the Exchange Act.
The 2024-2025 Repurchase Program permitted us to effect repurchases through a variety of methods, including open-market purchases (including pursuant to a trading plan adopted in accordance with Rule 10b5-1 of the Exchange Act), privately negotiated transactions, or otherwise in compliance with Rule 10b-18 of the Exchange Act.
We cannot be sure that high-quality coverage and reimbursement will be available for any product that we commercialize and, if reimbursement is available, what the level of reimbursement will be and whether it will be satisfactory. ​ Reimbursement rates may vary according to the use of the drug and the clinical setting in which it is used, may be based on reimbursement levels already set for lower cost drugs and may be incorporated into existing payments for other services.
We cannot be sure that high-quality coverage and reimbursement will be available for any product that we commercialize and, if reimbursement is available, what the level of reimbursement will be and whether it will be satisfactory. 31 Table of Contents Reimbursement rates may vary according to the use of the drug and the clinical setting in which it is used, may be based on reimbursement levels already set for lower cost drugs and may be incorporated into existing payments for other services.
We cannot currently determine the ultimate scope and validity of patents which may be granted to third parties in the future or which patents might be asserted to be infringed by the manufacture, use and sale of our products. ​ If we are found to infringe a third party’s intellectual property rights, we could be required to obtain a license from such third party to continue developing or commercializing our products and technology.
We cannot currently determine the ultimate scope and validity of patents which may be granted to third parties in the future or which patents might be asserted to be infringed by the manufacture, use and sale of our products. 27 Table of Contents If we are found to infringe a third party’s intellectual property rights, we could be required to obtain a license from such third party to continue developing or commercializing our products and technology.
These consequences may include: government enforcement actions (for example, investigations, fines, penalties, audits, and inspections); additional reporting requirements and/or oversight; restrictions on processing sensitive data (including personal data); litigation (including class claims); indemnification obligations; negative publicity; reputational harm; monetary fund diversions; interruptions in our operations (including availability of data); financial loss; and other similar harms.
These consequences may include: government enforcement actions (for example, investigations, fines, penalties, audits, and inspections); additional reporting requirements and/or oversight; restrictions on processing sensitive data (including personal data); litigation (including class claims); indemnification obligations; negative publicity; reputational harm; monetary fund diversions; interruptions in our operations (including availability of data); financial loss; 37 Table of Contents and other similar harms.
If our operations are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties, damages, fines, imprisonment, exclusion from participation in government funded healthcare programs, such as Medicare and Medicaid, and the curtailment or restructuring of our operations.
If our operations are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties, 39 Table of Contents damages, fines, imprisonment, exclusion from participation in government funded healthcare programs, such as Medicare and Medicaid, and the curtailment or restructuring of our operations.
Liabilities for taxes or assessments under any such laws could have an adverse impact on our results of operations. ​ California and several other states have enacted legislation related to prescription drug pricing transparency and it is unclear the effect this legislation will have on our business.
Liabilities for taxes or assessments under any such laws could have an adverse impact on our results of operations. 30 Table of Contents California and several other states have enacted legislation related to prescription drug pricing transparency and it is unclear the effect this legislation will have on our business.
Additional share repurchases under the 2024-2025 Repurchase Program will depend upon, among other factors, our cash balances and potential future capital requirements, our results of operations and financial condition, the price of our common stock on the Nasdaq Global Select Market, and other factors that we may deem relevant.
Share repurchases under the 2025-2026 Repurchase Program will depend upon, among other factors, our cash balances and potential future capital requirements, our results of operations and financial condition, the price of our common stock on the NASDAQ Global Select Market, and other factors that we may deem relevant.
In December 2021, we entered into an Assurance of Discontinuance with the Massachusetts Attorney General pursuant to which we provided certain assurances and agreed to pay certain of the Massachusetts Attorney General’s costs of investigation, in exchange for closure of the investigation and a release of claims pertaining to the subject matter of the investigation.
In 38 Table of Contents December 2021, we entered into an Assurance of Discontinuance with the Massachusetts Attorney General pursuant to which we provided certain assurances and agreed to pay certain of the Massachusetts Attorney General’s costs of investigation, in exchange for closure of the investigation and a release of claims pertaining to the subject matter of the investigation.
Jornay’s active ingredient, methylphenidate hydrochloride, Xtampza ER’s active ingredient, oxycodone, and the Nucynta Products’ active ingredient, tapentadol hydrochloride are each classified as Schedule II controlled substances under the Controlled Substances Act (“CSA”) and regulations of the DEA, and the active ingredient in Belbuca, buprenorphine hydrochloride, is classified as a Schedule III controlled substance .
Jornay PM’s active ingredient, methylphenidate hydrochloride, Xtampza ER’s active ingredient, oxycodone, and the Nucynta Products’ active ingredient, tapentadol hydrochloride are each classified as Schedule II controlled substances under the Controlled Substances Act (“CSA”) and regulations of the DEA, and the active ingredient in Belbuca, buprenorphine hydrochloride, is classified as a Schedule III controlled substance .
Such efforts may inhibit our ability to continue to commercialize our products. ​ Aggressive enforcement and unfavorable publicity regarding, for example, the use or misuse of oxycodone or other opioid drugs; the limitations of abuse-resistant formulations; the ability of people who abuse drugs to discover previously unknown ways to abuse opioid drugs and stimulants, including Xtampza ER, the Nucynta Products, Belbuca and Jornay; public inquiries and investigations into prescription drug abuse; litigation; or regulatory activity regarding sales, marketing, distribution or storage of opioid and stimulant drugs could have a material adverse effect on our reputation.
Aggressive enforcement and unfavorable publicity regarding, for example, the use or misuse of oxycodone or other opioid drugs; the limitations of abuse-resistant formulations; the ability of people who abuse drugs to discover previously unknown ways to abuse opioid drugs and stimulants, including Xtampza ER, the Nucynta Products, Belbuca and Jornay PM; public inquiries and investigations into prescription drug abuse; litigation; or regulatory activity regarding sales, marketing, distribution or storage of opioid and stimulant drugs could have a material adverse effect on our reputation.
If we are required to provide product samples or allocate additional resources to respond to such requests or any legal challenges under this law, our business could be adversely impacted. ​ Risks Related to Our Dependence on Third Parties ​ If the third-party manufacturers of our products fail to devote sufficient time and resources to these products, or their performance is substandard, and/or we encounter challenges with our dedicated manufacturing suite at our third-party manufacturer’s site for the manufacturing of Xtampza ER, our costs may be higher than expected and could have a material adverse effect on our business. ​ We do not own any manufacturing facilities in drug development and commercial manufacturing.
If we are required to provide product samples or allocate additional resources to respond to such requests or any legal challenges under this law, our business could be adversely impacted. 33 Table of Contents Risks Related to Our Dependence on Third Parties If the third-party manufacturers of our products fail to devote sufficient time and resources to these products, or their performance is substandard, and/or we encounter challenges with our dedicated manufacturing suite at our third-party manufacturer’s site for the manufacturing of Xtampza ER, our costs may be higher than expected and could have a material adverse effect on our business.
The 2024 Loan Agreement includes various customary remedies for the lenders following an event of default, including the acceleration of repayment of outstanding amounts under the 2024 Loan Agreement and execution upon the collateral securing obligations under the 2024 Loan Agreement.
The 2025 Credit Agreement includes various customary remedies for the lenders following an event of default, including the acceleration of repayment of outstanding amounts under the 2025 Credit Agreement and execution upon the collateral securing obligations under the 2025 Credit Agreement.
We currently have no plans to build our own clinical or commercial scale manufacturing facility and do not have the resources and expertise to manufacture and test, on a commercial scale, the technical performance of our products.
We do not own any manufacturing facilities in drug development and commercial manufacturing. We currently have no plans to build our own clinical or commercial scale manufacturing facility and do not have the resources and expertise to manufacture and test, on a commercial scale, the technical performance of our products.
The failure to obtain or maintain requisite governmental approvals or the imposition of additional or stronger warnings could delay or preclude us from realizing the full commercial potential of our products. ​ Risks Related to Intellectual Property ​ Unfavorable outcomes in intellectual property litigation could be costly and potentially limit our ability to commercialize our products. ​ Our commercial success depends upon our ability to commercialize products without infringing the intellectual property rights of others.
The failure to obtain or maintain requisite governmental approvals or the imposition of additional or stronger warnings could delay or preclude us from realizing the full commercial potential of our products. Risks Related to Intellectual Property Unfavorable outcomes in intellectual property litigation could be costly and potentially limit our ability to commercialize our products.
Acceptance and use of our products will depend on a number of factors including: ​ ● approved indications, warnings and precautions language that may be less desirable than competitive products; ● perceptions of physicians and other healthcare community members of the safety and efficacy of our products; ● perceptions by members of the healthcare community, including physicians, about the relevance and efficacy of our abuse deterrent technology; ● the availability of competitive products; ● the pricing and cost-effectiveness of our products relative to competing products; ● the potential and perceived advantages of our products over alternative treatments; ● the convenience and ease of administration to patients of our products; ● actual and perceived availability and quality of coverage and reimbursement for our products from government or other third-party payors; ● negative publicity related to our products or negative or positive publicity related to our competitors’ products; ● the prevalence and severity of adverse side effects; ● policy initiatives by FDA, HHS, DEA, or other federal or state agencies regarding opioids; ● our ability to comply with the Opioid Analgesic REMS; and ● the effectiveness of marketing and distribution efforts by us and any licensees and distributors. ​ If our products fail to have an adequate level of acceptance by the medical community, patients, or healthcare payors, we will not be able to generate sufficient revenue to remain profitable.
Acceptance and use of our products will depend on a number of factors including: • approved indications, warnings and precautions language that may be less desirable than competitive products; • perceptions of physicians and other healthcare community members of the safety and efficacy of our products; • perceptions by members of the healthcare community, including physicians, about the relevance and efficacy of our abuse deterrent technology; • the availability of competitive products; • the pricing and cost-effectiveness of our products relative to competing products; • the potential and perceived advantages of our products over alternative treatments; • the convenience and ease of administration to patients of our products; 29 Table of Contents • actual and perceived availability and quality of coverage and reimbursement for our products from government or other third-party payors; • negative publicity related to our products or negative or positive publicity related to our competitors’ products; • the prevalence and severity of adverse side effects; • policy initiatives by FDA, HHS, DEA, or other federal or state agencies regarding opioids; • our ability to comply with the Opioid Analgesic REMS; and • the effectiveness of marketing and distribution efforts by us and any licensees and distributors.
A finding of infringement could prevent us from commercializing our products or force us to cease some of our business operations. ​ Any litigation, including any interference or derivation proceedings to determine priority of inventions, oppositions, reexaminations, inter partes reviews or other post-grant review proceedings to patents in the United States, or litigation against our collaborators may be costly and time consuming and could have a material adverse effect on our operating results, our ability to raise capital needed to commercialize products and our overall financial condition.
Any litigation, including any interference or derivation proceedings to determine priority of inventions, oppositions, reexaminations, inter partes reviews or other post-grant review proceedings to patents in the United States, or litigation against our collaborators may be costly and time consuming and could have a material adverse effect on our operating results, our ability to raise capital needed to commercialize products and our overall financial condition.
Laws intended to broaden access to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies against fraud and abuse, add new transparency requirements for health care and health insurance industries, impose new taxes and fees on the health industry and impose additional health policy reforms may continue the downward pressure on pharmaceutical pricing, especially under the Medicare program, and may also increase our regulatory burdens and operating costs. ​ Legislative and regulatory proposals have been made to expand post-approval requirements and restrict sales and promotional activities for pharmaceutical products.
Laws intended to broaden access to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies against fraud and abuse, add new transparency requirements for health care and health insurance industries, impose new taxes and fees on the health industry and impose additional health policy reforms may continue the downward pressure on pharmaceutical pricing, especially under the Medicare program, and may also increase our regulatory burdens and operating costs.
Any of these consequences would harm the commercial success of our products, including Xtampza ER. ​ Further, discovery of serious and unanticipated adverse events associated with the product; the emergence of other problems with the product, manufacturer or facility; or our failure to make required regulatory submissions may result in adverse regulatory actions, including withdrawal of the product from the market or the requirement to add or strengthen label warnings about the product.
Further, discovery of serious and unanticipated adverse events associated with the product; the emergence of other problems with the product, manufacturer or facility; or our failure to make required regulatory submissions may result in adverse regulatory actions, including withdrawal of the product from the market or the requirement to add or strengthen label warnings about the product.
We contract with these suppliers for commercial supply to manufacture our products. Further, our suppliers of the active pharmaceutical ingredients for Xtampza ER and the Nucynta Products also supply our primary competitor in the extended-release oxycodone space, Purdue. Identifying alternate sources of active pharmaceutical ingredients for our products is generally time-consuming and costly.
We contract with these suppliers for commercial supply to manufacture our products. Further, our suppliers of the active pharmaceutical ingredients for Xtampza ER and the Nucynta Products also supply our primary competitor in the extended-release oxycodone space, Purdue.
If a natural disaster, power outage, health epidemic or other event occurred that prevented us from using all or a significant portion of our facilities, that damaged critical infrastructure, such as the manufacturing facilities of our third-party contract manufacturers, or that otherwise disrupted operations, it might become difficult or, in certain cases, impossible for us to continue our business, and any disruption could last for a substantial period of time. ​ The disaster recovery and business continuity plans we have in place, and the technology that we may rely upon to implement such plans, may prove inadequate in the event of a serious disaster or similar event.
If a natural disaster, power outage, health epidemic or other event occurred that prevented us from using all or a significant portion of our facilities, that damaged critical infrastructure, such as the manufacturing facilities of our third-party contract manufacturers, or that otherwise disrupted operations, it might become difficult or, in certain cases, impossible for us to continue our business, and any disruption could last for a substantial period of time.
The U.S. federal and state NOL carryforwards expire at various dates through 2037. Federal NOLs and certain state NOLs incurred in 2018 and onward have an indefinite expiration under the Tax Cuts and Jobs Act of 2017 and applicable state statutes. We also had U.S. federal tax credits of approximately $1.0 million. We do not have any state tax credits.
Federal NOLs and certain state NOLs incurred in 2018 and onward have an indefinite expiration under the Tax Cuts and Jobs Act of 2017 and applicable state statutes. We also had U.S. federal tax credits of approximately $0.7 million. We do not have any state tax credits.
Refer to the section entitled “Business — Government Regulation — Healthcare Fraud and Abuse Laws and Compliance Requirements” for more information. ​ We or the third parties upon whom we depend may be adversely affected by natural disasters and/or health epidemics, and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster. ​ Natural disasters could severely disrupt our operations, and have a material adverse effect on our business, results of operations, financial condition and prospects.
Refer to the section entitled “Business — Government Regulation — Healthcare Fraud and Abuse Laws and Compliance Requirements” for more information. We or the third parties upon whom we depend may be adversely affected by natural disasters and/or health epidemics, and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.
Our arrangements with payors and customers may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the business or financial arrangements and relationships through which we market, sell and distribute our products.
Healthcare providers, physicians and payors play a primary role in the recommendation and prescription of our products. Our arrangements with payors and customers may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the business or financial arrangements and relationships through which we market, sell and distribute our products.
Current and future legislation may significantly change these approval requirements in ways that could involve additional costs and cause delays in obtaining approvals. Pricing limitations may hinder our ability to recoup our investment in our products.
The regulations that govern marketing approvals, pricing and reimbursement for drug products can vary widely. Current and future legislation may significantly change these approval requirements in ways that could involve additional costs and cause delays in obtaining approvals. Pricing limitations may hinder our ability to recoup our investment in our products.
Products of these types are marketed by Actavis, Endo, Mallinckrodt, Purdue, Teva, Vertex Pharmaceuticals Incorporated (“Vertex”) and others. Jornay competes with currently marketed, branded and generic methylphenidate products for the treatment of ADHD. Products of these types are marketed by J&J Innovative Medicines, Supernus Pharmaceuticals, Inc., Tris 38 ​ Pharma, Novartis AG, Noven Therapeutics, LLC, UCB SA, Aytu BioScience, Inc.
Jornay PM competes with currently marketed, branded and generic methylphenidate products for the treatment of ADHD. Products of these types are marketed by J&J Innovative Medicines, Supernus Pharmaceuticals, Inc., Tris Pharma, Novartis AG, Noven Therapeutics, LLC, UCB SA, Aytu BioScience, Inc. Adlon Therapeutics, Inc.
If any of our trade secrets were to be disclosed or independently developed, our competitive position would be harmed. ​ Obtaining and maintaining our patent protection depends on compliance with various procedural, document submissions, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements. ​ The United States Patent and Trademark Office (“USPTO”) requires compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process.
If any of our trade secrets were to be disclosed or independently developed, our competitive position would be harmed. Obtaining and maintaining our patent protection depends on compliance with various procedural, document submissions, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
If the demand for Xtampza ER and any future related products never meets our expectations and forecasts, or if we do not produce the output we plan, we may not be able to realize the return on investment we anticipated, which would have a negative impact on our financial condition and results of operations. ​ Although we have identified alternate sources for these services, it would be time-consuming, and require us to incur additional costs, to qualify these sources.
If the demand for Xtampza ER and any future related products never meets our expectations and forecasts, or if we do not produce the output we plan, we may not be able to realize the return on investment we anticipated, which would have a negative impact on our financial condition and results of operations.
In addition, an adverse result in any litigation proceeding could put one or more of our patents at risk of being invalidated, held unenforceable or interpreted narrowly. ​ If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed. ​ In addition to seeking patents for some of our technology and products, we rely on trade secrets, including unpatented know-how, technology and other proprietary information, to maintain our competitive position.
In addition, an adverse result in any litigation proceeding could put one or more of our patents at risk of being invalidated, held unenforceable or interpreted narrowly. If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
Earlier market entry of generic abuse-deterrent formulations could have a material adverse effect on our business. ​ Additionally, the Creating and Restoring Equal Access to Equivalent Samples Act (the “CREATES Act”), was enacted in 2019 requiring sponsors of approved drugs to provide sufficient quantities of product samples on commercially reasonable, market-based terms to entities developing generic drugs.
Additionally, the Creating and Restoring Equal Access to Equivalent Samples Act (the “CREATES Act”), was enacted in 2019 requiring sponsors of approved drugs to provide sufficient quantities of product samples on commercially reasonable, market-based terms to entities developing generic drugs.
Physicians and others in the medical community, patients, and healthcare payors may not continue to accept and use our products, or accept and use any new products that we may acquire.
If the medical community, patients, and healthcare payors do not accept and use our products, we will not achieve sufficient product revenues and our business will suffer. Physicians and others in the medical community, patients, and healthcare payors may not continue to accept and use our products, or accept and use any new products that we may acquire.
Refer to the sections entitled “Business — Government Regulation — Third-Party Payor Coverage and Reimbursement” and “ — Healthcare Reform” for more information. ​ Our ability to market and sell any product successfully will also depend in part on the extent to which coverage and adequate reimbursement for these products and related treatments are available from government health administration authorities, private health insurers and other organizations.
Our ability to market and sell any product successfully will also depend in part on the extent to which coverage and adequate reimbursement for these products and related treatments are available from government health administration authorities, private health insurers and other organizations.
For example, several states, including New York, have imposed taxes or fees on the sale of opioids. Other states, and even the federal government, could impose similar taxes or fees, and such laws and proposals can vary in the tax and fee amounts imposed and the means of calculation.
Other states, and even the federal government, could impose similar taxes or fees, and such laws and proposals can vary in the tax and fee amounts imposed and the means of calculation.
We expect that additional changes to the Affordable Care Act, the Medicare and Medicaid programs, changes in the Inflation Reduction Act of 2022 that allow the federal government to directly negotiate drug prices, and changes stemming from other healthcare reform measures, including any new regulatory measures proposed or implemented by the Trump Administration, especially with regard to healthcare access and cost, as well as other legislation in individual states, could have a material adverse effect on the healthcare industry. ​ Any reduction in reimbursement from Medicare, Medicaid, or other government programs may result in a similar reduction in payments from private payors.
We expect that additional changes to the Affordable Care Act, the Medicare and Medicaid programs, implementation of the Inflation Reduction Act of 2022, including Medicare drug price negotiation, rebate and Part D redesign provisions, and changes stemming from other healthcare reform measures, including any new regulatory measures proposed or implemented by the Trump Administration, especially with regard to healthcare access and cost, as well as other legislation in individual states, could have a material adverse effect on the healthcare industry.
These authorized generics and any other generic entrants into the market may impact our net revenue for the Nucynta Products. ​ In November 2017, the FDA issued a final guidance to assist the industry in the development of generic versions of approved opioids with abuse-deterrent formulations, including recommendations about the types of studies that companies should conduct to demonstrate that the generic drug is no less abuse-deterrent than its brand-name counterpart.
In November 2017, the FDA issued a final guidance to assist the industry in the development of generic versions of approved opioids with abuse-deterrent formulations, including recommendations about the types of studies that companies should conduct to demonstrate that the generic drug is no less abuse-deterrent than its brand-name counterpart.
In addition, some courts in the United States may be less willing or unwilling to protect trade secrets. If any of our trade secrets were to be lawfully obtained or independently developed by a competitor, we would have no right to prevent such competitor, or those with whom they communicate, from using that technology or information to compete with us.
If any of our trade secrets were to be lawfully obtained or independently developed by a 28 Table of Contents competitor, we would have no right to prevent such competitor, or those with whom they communicate, from using that technology or information to compete with us.
These guidances are part of the FDA’s wider focus on assisting developers of generic abuse-deterrent formulations in navigating the regulatory path to market more quickly.
These guidances are part of the FDA’s wider focus on assisting developers of generic abuse-deterrent formulations in navigating the regulatory path to market more quickly. Earlier market entry of generic abuse-deterrent formulations could have a material adverse effect on our business.
Additionally, a greater number of third-party payors may seek discounts and rebates in order to offer or maintain access for our products.
Additionally, a greater number of third-party payors may seek discounts and rebates in order to offer or maintain access for our products, particularly in light of heightened governmental scrutiny of prescription drug pricing and reimbursement practices.
The significance of each wholesale pharmaceutical distributor account to our business adversely impacts our ability to negotiate favorable commercial terms 36 ​ with each such distributor, and as a result, we may be forced to accept terms that adversely impact our results of operations. ​ In addition, these wholesaler customers comprise a significant part of the distribution network for pharmaceutical products in the United States.
The significance of each wholesale pharmaceutical distributor account to our business adversely impacts our ability to negotiate favorable commercial terms with each such distributor, and as a result, we may be forced to accept terms that adversely impact our results of operations.
Such withdrawal or restriction or labeling changes for our products would have an adverse impact on our business and financial condition. ​ Risks Related to Our Business and Strategy ​ Our business may be adversely affected by certain events or circumstances outside our control, including macroeconomic conditions and geopolitical turmoil. ​ Events or circumstances outside of our control, including macroeconomic conditions such as recession or depression, inflation, and declines in consumer-spending could result in reduced demand for our products.
Our business may be adversely affected by certain events or circumstances outside our control, including macroeconomic conditions and geopolitical turmoil. Events or circumstances outside of our control, including macroeconomic conditions such as recession or depression, inflation, and declines in consumer-spending could result in reduced demand for our products.
We and our suppliers, manufacturers, contractors, customers and distributors are required to obtain and maintain applicable registrations from state and federal law enforcement and regulatory agencies and comply with state and federal laws and regulations regarding the manufacture, use, sale, importation, exportation and distribution of controlled substances. ​ Furthermore, the amount of Schedule II substances that can be obtained for clinical trials and commercial distribution is limited by the CSA and DEA regulations.
We and our suppliers, manufacturers, contractors, customers and distributors are required to obtain and maintain applicable registrations from state and federal law enforcement and regulatory agencies and comply with state and federal laws and regulations regarding the manufacture, use, sale, importation, exportation and distribution of controlled substances.
Any decline in available funding or access to cash and liquidity resources could, among other risks, adversely impact our ability to meet our financial obligations, which could have material adverse impacts on our liquidity and our business, financial condition, or results of operations. ​ Risks Related to our Products ​ If we cannot continue successfully commercializing our products and any products that we may acquire in the future, our business, financial condition and results of operations may be materially adversely affected and the price of our common stock may decline. ​ Our business and future success are substantially dependent on our ability to continue successfully commercializing our products, including Jornay, Belbuca, Xtampza, the Nucynta Products, Symproic, and any products that we may acquire in the future. ​ Our ability to continue successfully commercializing our products will depend on many factors, including but not limited to: ​ ● our ability to manufacture commercial quantities of our products at reasonable cost and with sufficient speed to meet commercial demand; ● our ability to execute sales and marketing strategies successfully and continually; ● our success in educating physicians, patients and caregivers about the benefits, administration, use and coverage of our products; ● with respect to Xtampza ER, the perceived availability and advantages, relative cost, relative safety and relative efficacy of other abuse-deterrent products and treatments with similar indications; 26 ​ ● our ability to defend successfully any challenges to our intellectual property or suits asserting patent infringement relating to our products; ● the availability and quality of coverage and adequate reimbursement for our products; ● a continued acceptable safety profile of our products; ● our ability to acquire new products, or develop new indications or line extensions for existing products, in the event that revenues from our existing products are impacted by price controls, loss of intellectual property exclusivity or competition; and ● our ability to comply with applicable legal and regulatory requirements, including any additional manufacturing or packaging requirements that may become applicable to certain opioid products. ​ Many of these matters are beyond our control and are subject to other risks described elsewhere in this “Risk Factors” section.
Our ability to continue successfully commercializing our products will depend on many factors, including but not limited to: • our ability to manufacture commercial quantities of our products at reasonable cost and with sufficient speed to meet commercial demand; • our ability to execute sales and marketing strategies successfully and continually; • our success in educating physicians, patients and caregivers about the benefits, administration, use and coverage of our products; • with respect to Xtampza ER, the perceived availability and advantages, relative cost, relative safety and relative efficacy of other abuse-deterrent products and treatments with similar indications; • our ability to defend successfully any challenges to our intellectual property or suits asserting patent infringement relating to our products; • the availability and quality of coverage and adequate reimbursement for our products; • a continued acceptable safety profile of our products; • our ability to acquire new products, or develop new indications or line extensions for existing products, in the event that revenues from our existing products are impacted by price controls, loss of intellectual property exclusivity or competition; and • our ability to comply with applicable legal and regulatory requirements, including any additional manufacturing or packaging requirements that may become applicable to certain opioid products.
Our current or future products, or any uses of them, may now or in the future infringe third-party patents or other intellectual property rights.
Our commercial success depends upon our ability to commercialize products without infringing the intellectual property rights of others. Our current or future products, or any uses of them, may now or in the future infringe third-party patents or other intellectual property rights.
Because the FDA closely regulates promotional materials and other promotional activities, even though the FDA-approved product labeling includes a description of the abuse deterrent characteristics of Xtampza ER, the FDA may object to our marketing claims and product advertising campaigns. ​ Engaging in off-label promotion of our products, including Xtampza ER, could subject us to false claims liability under federal and state statutes, and other litigation and/or investigations, and could lead to the issuance of warning letters or untitled letters, suspension or withdrawal of our products from the market, recalls, fines, disgorgement money, operating restrictions, injunctions, and civil or criminal prosecution.
Engaging in off-label promotion of our products, including Xtampza ER, could subject us to false claims liability under federal and state statutes, and other litigation and/or investigations, and could lead to the issuance of warning letters or untitled letters, suspension or withdrawal of our products from the market, recalls, fines, disgorgement money, operating restrictions, injunctions, and civil or criminal prosecution.
In addition, in any such proceeding or litigation, we could be found liable for monetary damages, including treble damages and attorneys’ fees, if we are found to have willfully infringed a patent.
In addition, in any such proceeding or litigation, we could be found liable for monetary damages, including treble damages and attorneys’ fees, if we are found to have willfully infringed a patent. A finding of infringement could prevent us from commercializing our products or force us to cease some of our business operations.
In late March 2023, three new cases were filed in three federal courts, naming us as one of numerous defendants, from which we have been dismissed. ​ Certain governmental and regulatory agencies are focused on the abuse of opioid medications, a concern we share, and we have received Civil Investigative Demands or subpoenas from four state attorneys general investigating our sales and marketing of opioids and seeking documents relating to the manufacture, marketing and sale of opioid medications.
Certain governmental and regulatory agencies are focused on the abuse of opioid medications, a concern we share, and we have received Civil Investigative Demands or subpoenas from four state attorneys general investigating our sales and marketing of opioids and seeking documents relating to the manufacture, marketing and sale of opioid medications.
These treatments will compete with our products and the established use of these competitive products may limit the potential for our products to receive widespread acceptance. ​ Commercial sales of our products and any products we acquire, may expose us to expensive product liability claims, and we may not be able to maintain product liability insurance on reasonable terms or at all. ​ We currently carry product liability insurance.
Commercial sales of our products and any products we acquire, may expose us to expensive product liability claims, and we may not be able to maintain product liability insurance on reasonable terms or at all. We currently carry product liability insurance.
We are required, under Section 404 of the Sarbanes-Oxley Act, to furnish a report by management on, among other things, the effectiveness of our internal control over financial reporting. If we identify one or more material weaknesses in our internal control over financial reporting, we will be unable to assert that our internal control over financial reporting is effective.
The Sarbanes-Oxley Act requires, among other things, that we maintain effective internal control over financial reporting. We are required, under Section 404 of the Sarbanes-Oxley Act, to furnish a report by management on, among other things, the effectiveness of our internal control over financial reporting.
This facility requires the maintenance of regulatory approvals and other costs, all of which we absorb. We cannot guarantee that we will be able to continue to leverage the dedicated manufacturing suite in a profitable manner.
Xtampza ER is manufactured in a dedicated suite at a site operated by our contract manufacturing organization, Patheon, part of Thermo Fisher Scientific. This facility requires the maintenance of regulatory approvals and other costs, all of which we absorb. We cannot guarantee that we will be able to continue to leverage the dedicated manufacturing suite in a profitable manner.
As of December 31, 2024, there were outstanding options to purchase an aggregate of 803,406 shares of our common stock at a weighted average exercise price of $20.84 per share, of which options to purchase 673,062 shares of our common stock were then exercisable.
As of December 31, 2025, there were outstanding options to purchase an aggregate of 559,161 shares of our common stock at a weighted average exercise price of $22.29 per share, of which options to purchase 461,403 shares of our common stock were then exercisable.
In particular, if the FDA determines that our post-marketing data for Xtampza ER does not demonstrate that the abuse-deterrent properties result in reduction of abuse, or demonstrates a shift to routes of abuse that present a greater risk, the FDA may find that product labeling revisions are needed, and potentially require the removal of our abuse-deterrence claims, which would have a material adverse effect on our ability to continue successfully commercializing Xtampza ER. ​ Our opioid products are subject to mandatory REMS programs, which could increase the cost, burden and liability associated with the commercialization of these products. ​ The FDA has imposed a class-wide REMS on all IR, ER and long-acting opioid drug products (known as the Opioid Analgesic REMS).
Additionally, if the FDA determines that our post-marketing data for Xtampza ER does not demonstrate that the abuse-deterrent properties result in reduction of abuse, or demonstrates a shift to routes of abuse that present a greater risk, the FDA may find that product labeling revisions are needed, and potentially require the removal of our abuse-deterrence claims, which would have a material adverse effect on our ability to continue successfully commercializing Xtampza ER.
Any changes that our suppliers make to the respective drug substance raw materials, intermediates, or manufacturing processes would introduce technical and regulatory risks to our downstream drug product supply.
Identifying alternate sources of active pharmaceutical ingredients for our products is generally time-consuming and costly. Any changes that our suppliers make to the respective drug substance raw materials, intermediates, or manufacturing processes would introduce technical and regulatory risks to our downstream drug product supply.
If we fail to maintain the patents and patent applications covering our products, our competitive position would be adversely affected. ​ 29 ​ Risks Related to the Commercialization of Our Products ​ If we are unable to utilize our own sales and marketing capabilities successfully or enter into strategic alliances with marketing collaborators, we may not continue to be successful in commercializing our products and may be unable to generate sufficient product revenue. ​ Our commercial organization continues to evolve and we cannot guarantee that we will continue to be successful in marketing our products.
Risks Related to the Commercialization of Our Products If we are unable to utilize our own sales and marketing capabilities successfully or enter into strategic alliances with marketing collaborators, we may not continue to be successful in commercializing our products and may be unable to generate sufficient product revenue.
In addition, these provisions make it more difficult for our shareholders to remove our Board of Directors or management or elect new directors to our Board of Directors. ​ If we fail to maintain an effective system of internal control over financial reporting, we may not be able to report our financial condition, results of operations or cash flows accurately, which may adversely affect investor confidence in us and, as a result, the value of our common stock. ​ The Sarbanes-Oxley Act requires, among other things, that we maintain effective internal control over financial reporting.
If we fail to maintain an effective system of internal control over financial reporting, we may not be able to report our financial condition, results of operations or cash flows accurately, which may adversely affect investor confidence in us and, as a result, the value of our common stock.
Moreover, the exercise of options and other issuances of shares of common stock or securities convertible into or exercisable for shares of common stock will dilute your ownership interests and may adversely affect the future market price of our common stock. ​ Sales of our common stock in the public market, either by us or by our current shareholders, or the perception that these sales could occur, could cause a decline in the market price of our securities.
Moreover, the exercise of options and other issuances of shares of common stock or securities convertible into or exercisable for shares of common stock will dilute your ownership interests and may adversely affect the future market price of our common stock.
Our ability to generate revenue from our current or future products depends on a number of factors, including our ability to: ​ ● realize a commercially viable price for our products; ● manufacture commercial quantities of our products at acceptable cost levels; ● sustain a commercial organization capable of sales, marketing and distribution for the products we sell; ● obtain coverage and adequate reimbursement from third parties, including government payors; ● acquire new products, or develop new indications or line extensions for existing products, in the event that revenues from our existing products are impacted by price controls, loss of intellectual property exclusivity or competition; and ● comply with existing and changing laws and regulations that apply to the pharmaceutical industry, including opioid manufacturers, and to our products specifically, including FDA post-marketing requirements. ​ If we fail to maintain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and be forced to reduce our operations. 24 ​ ​ Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited. ​ As of December 31, 2024, we had a gross U.S. federal net operating loss (“NOL”) carryforward of approximately $102.1 million and state NOL carryovers of approximately $199.0 million.
Our ability to generate revenue from our current or future products depends on a number of factors, including our ability to: • realize a commercially viable price for our products; • manufacture commercial quantities of our products at acceptable cost levels; • sustain a commercial organization capable of sales, marketing and distribution for the products we sell; • obtain coverage and adequate reimbursement from third parties, including government payors; • acquire new products, or develop new indications or line extensions for existing products, in the event that revenues from our existing products are impacted by price controls, loss of intellectual property exclusivity or competition; and • comply with existing and changing laws and regulations that apply to the pharmaceutical industry, including opioid manufacturers, and to our products specifically, including FDA post-marketing requirements.
We currently rely, and expect to continue to rely, on a limited number of experienced personnel and contract manufacturers for our products, as well as 34 ​ other vendors to formulate, test, supply, store and distribute our products, and we control only certain aspects of their activities. ​ Xtampza ER is manufactured in a dedicated suite at a site operated by our contract manufacturing organization, Patheon, part of Thermo Fisher Scientific.
We currently rely, and expect to continue to rely, on a limited number of experienced personnel and contract manufacturers for our products, as well as other vendors to formulate, test, supply, store and distribute our products, and we control only certain aspects of their activities.
Our contract manufacturers and vendors may not perform as agreed or may not remain in the contract manufacturing business for the time required to produce, store and distribute our products successfully; and ● If our contract manufacturers were to terminate our arrangements or fail to meet our commercial manufacturing demands, we may be forced to delay our development and commercial programs. ​ Failure to obtain the necessary active pharmaceutical ingredients, excipients or components necessary to manufacture our products could adversely affect our ability to continue to commercialize our products, which could in turn adversely affect our results of operations and financial condition.
Our contract manufacturers and vendors may not perform as agreed or may not remain in the contract manufacturing business for the time required to produce, store and distribute our products successfully; and • If our contract manufacturers were to terminate our arrangements or fail to meet our commercial manufacturing demands, we may be forced to delay our development and commercial programs.
If commercial demand for Xtampza ER, the Nucynta Products or Jornay, increases and we cannot meet such demand in a timely fashion because of our limited supply of their active pharmaceutical ingredients, then physicians may perceive such product as unavailable and may be less likely to prescribe it in the future. ​ In addition, controlled substances are also subject to regulations governing manufacturing, labeling, packaging, testing, dispensing, production and procurement quotas (for Schedule I and II substances), recordkeeping, reporting, handling, shipment and disposal.
If commercial demand for Xtampza ER, the Nucynta Products or Jornay PM, increases and we cannot meet such demand in a timely fashion because of our limited supply of their active pharmaceutical ingredients, then physicians may perceive such product as unavailable and may be less likely to prescribe it in the future.
Litigation could result in substantial costs and diversion of management resources, which could have a material adverse effect on our operating results, our ability to raise capital needed to commercialize products and our overall financial condition.
Accordingly, despite our efforts, we may not be able to prevent third parties from infringing upon or misappropriating our intellectual property. Litigation could result in substantial costs and diversion of management resources, which could have a material adverse effect on our operating results, our ability to raise capital needed to commercialize products and our overall financial condition.
This distribution network has undergone, and may continue to undergo, significant consolidation marked by mergers and acquisitions. As a result, a small number of large wholesale distributors control a significant share of the market. Consolidation of drug wholesalers has increased, and may continue to increase, competitive and pricing pressures on pharmaceutical products.
In addition, these wholesaler customers comprise a significant part of the distribution network for pharmaceutical products in the United States. This distribution network has undergone, and may continue to undergo, significant consolidation marked by mergers and acquisitions. As a result, a small number of large wholesale distributors control a significant share of the market.
The FDA continually evaluates whether the REMS program is meeting its goal of ensuring that the benefit of these drugs continue to outweigh their risks, and whether the goals or elements of the program should be modified.
The FDA has imposed a class-wide REMS on all IR, ER and long-acting opioid drug products (known as the Opioid Analgesic REMS). The FDA continually evaluates whether the REMS program is meeting its goal of ensuring that the benefit of these drugs continue to outweigh their risks, and whether the goals or elements of the program should be modified.
We cannot be sure whether additional legislative changes will be enacted, or whether the FDA regulations, guidance or interpretations will be changed, or what the impact of such changes on the marketing of our products may be. Moreover, the U.S.
Legislative and regulatory proposals have been made to expand post-approval requirements and restrict sales and promotional activities for pharmaceutical products. We cannot be sure whether additional legislative changes will be enacted, or whether the FDA regulations, guidance or interpretations will be changed, or what the impact of such changes on the marketing of our products may be. Moreover, the U.S.
These provisions could limit the price that certain investors might be willing to pay in the future for shares of our common stock.
These provisions could limit the price that certain investors might be willing to pay in the future for shares of our common stock. In addition, these provisions make it more difficult for our shareholders to remove our Board of Directors or management or elect new directors to our Board of Directors.
Ultimately, the outcome of such litigation, including our pending litigation with Purdue, could compromise the validity and scope of our patents or other proprietary rights or hinder our ability to manufacture and market our products. ​ If we are unable to obtain or maintain intellectual property rights for our technologies, products or any products we may acquire, we may lose valuable assets or be unable to compete effectively in our market. ​ We depend on our ability to protect our proprietary technology.
If we are unable to obtain or maintain intellectual property rights for our technologies, products or any products we may acquire, we may lose valuable assets or be unable to compete effectively in our market. We depend on our ability to protect our proprietary technology.
Many of our current and potential future competitors have significantly greater research and development capabilities than we do, have substantially more marketing, manufacturing, financial, technical, human and managerial resources than we do, and have more institutional experience than we do. ​ Our competitors have developed or may develop technologies that are, or may be, the basis for competitive products that are safer, more effective or less costly than our products.
Some of these current and potential future competitors may be addressing the same therapeutic areas or indications as we are. Many of our current and potential future competitors have significantly greater research and development capabilities than we do, have substantially more marketing, manufacturing, financial, technical, human and managerial resources than we do, and have more institutional experience than we do.
The DEA may seek civil penalties, refuse to renew necessary registrations or initiate proceedings to revoke those registrations. In some circumstances, violations could lead to criminal proceedings.
The DEA may seek civil penalties, refuse to renew necessary registrations or initiate proceedings to revoke those registrations. In some circumstances, violations could lead to criminal proceedings. Because of their restrictive nature, these regulations could limit commercialization of our products containing controlled substances.
We may not be able to maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise.
We may not be able to maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise. Regardless of merit or eventual outcome, liability claims may cause us to incur significant costs to defend the litigation.
We have not hedged our interest rate exposure with respect to our floating rate debt. Accordingly, our interest expense for any period will fluctuate based on SOFR and other variable interest rates, as applicable.
Accordingly, our interest expense for any period will fluctuate based on SOFR and other variable interest rates, as applicable.
Such an interruption could have a material adverse impact on our business, including but not limited to, our ability to timely manufacture and distribute our products. ​ Manufacturing issues may arise that could increase product and regulatory approval costs, delay commercialization or limit commercial supply. ​ In our current commercial manufacturing operations, and as we scale up manufacturing of our products and conduct required stability testing, we may encounter product, packaging, equipment and process-related issues that may require refinement or resolution in order to successfully commercialize our products.
Such an interruption could have a material adverse impact on our business, including but not limited to, our ability to timely manufacture and distribute our products. 35 Table of Contents Manufacturing issues may arise that could increase product and regulatory approval costs, delay commercialization or limit commercial supply.
We rely on patent and trademark laws, unpatented trade secrets and know-how, and confidentiality, licensing and other agreements with employees and third parties, all of which offer only limited protection.
We rely on patent and trademark laws, unpatented trade secrets and know-how, and confidentiality, licensing and other agreements with employees and third parties, all of which offer only limited protection. Our success depends in large part on our ability to obtain and maintain patent protection in the United States with respect to our proprietary technology and products.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeThis includes updates, as appropriate, on key information technology initiatives, new and existing cybersecurity risks, how management is managing those risks, and, if any, material cybersecurity incidents and the impact to our business and performance. ​ At the management level, our Head of Information Technology is responsible for assessing and managing risks from cybersecurity threats through oversight of our information technology infrastructure and cybersecurity program.
Biggest changeThe Audit Committee receives updates at least quarterly from our Head of Information Technology regarding developments in our information technology infrastructure and cybersecurity program. This includes updates, as appropriate, on key information technology initiatives, new and existing cybersecurity risks, how management is managing those risks, and, if any, material cybersecurity incidents and the impact to our business and performance.
We also evaluate cybersecurity risks 41 ​ associated with third-party vendors that provide the hosted applications we use in our financial close process through review of their System and Organization Controls (“SOC”) 1 reports at least annually.
We also evaluate cybersecurity risks associated with third-party vendors that provide the hosted applications we use in our financial close process through review of their System and Organization Controls (“SOC”) 1 reports at least annually.
For more information about the cybersecurity risks we face, refer to “Item 1A. Risk Factors.” ​ Governance ​ One of the key functions of our Board is informed oversight of our risk management process.
For more information about the cybersecurity risks we face, refer to “Item 1A. Risk Factors.” 42 Table of Contents Governance One of the key functions of our Board is informed oversight of our risk management process.
We assess various risks, including cybersecurity related risks, based on the likelihood of an incident occurring, impact to our organization if an incident occurred, and the level of internal control we currently have over the risk.
We assess various risks, including cybersecurity related risks, based on the likelihood of an incident occurring, impact to our organization if an incident occurred, and the level of internal control we currently have over the risk. The results are analyzed to identify vulnerabilities and then risk management/mitigation plans are designed, implemented, and evaluated for effectiveness.
As part of our incident response plan, our Cybersecurity Incident Response Team (a cross-functional taskforce comprised of senior representatives), is responsible for convening to assess the potential impact to our business, including financial reporting requirements and legal implications. ​ We, like other companies in our industry, face a number of cybersecurity risks, including cybersecurity incidents, in connection with our business.
In the event of a cybersecurity incident, we maintain an incident response plan in an effort to contain and mitigate the threat. As part of our incident response plan, our Cybersecurity Incident Response Team (a cross-functional taskforce comprised of senior representatives), is responsible for convening to assess the potential impact to our business, including financial reporting requirements and legal implications.
The individual occupying this role has over 20 years of experience in information technology and cybersecurity and has served in senior cybersecurity leadership positions for over 10 years. Our Head of Information Technology conducts bi-weekly meetings with our information technology department to remain apprised of cybersecurity matters.
At the management level, our Head of Information Technology is responsible for assessing and managing risks from cybersecurity threats through oversight of our information technology infrastructure and cybersecurity program. The individual occupying this role has over 20 years of experience in information technology and cybersecurity and has served in senior cybersecurity leadership positions for over 10 years.
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The results are analyzed to identify vulnerabilities and then risk management/mitigation plans are designed, implemented, and evaluated for effectiveness. ​ In the event of a cybersecurity incident, we maintain an incident response plan in an effort to contain and mitigate the threat.
Added
We, like other companies in our industry, face a number of cybersecurity risks, including cybersecurity incidents, in connection with our business.
Removed
The Audit Committee receives updates at least quarterly from our Head of Information Technology regarding developments in our information technology infrastructure and cybersecurity program.
Added
Our Head of Information Technology conducts bi-weekly meetings with our information technology department to remain apprised of cybersecurity matters.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeThe corporate headquarters lease expires in September 2029 and the lease term may be extended for two additional five-year terms at our election. ​ We believe that our existing facilities are adequate for our current and expected future needs. We may seek to negotiate new leases or evaluate additional or alternate space for our operations.
Biggest changeWe believe that our existing facilities are adequate for our current and expected future needs. We may seek to negotiate new leases or evaluate additional or alternate space for our operations. We believe that appropriate alternative space is readily available on commercially reasonable terms.
Item 2. Properties ​ Our corporate headquarters are located in Stoughton, Massachusetts, where we lease 50,678 square feet of office and laboratory space. We use this facility for commercial and general and administrative purposes.
Item 2. Properties Our corporate headquarters are located in Stoughton, Massachusetts, where we lease 50,678 square feet of office and laboratory space. We use this facility for commercial and general and administrative purposes. The corporate headquarters lease expires in September 2029 and the lease term may be extended for two additional five-year terms at our election.
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We believe that appropriate alternative space is readily available on commercially reasonable terms. ​ 42 ​

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeRecent Sales of Unregistered Securities There were no unregistered sales of equity securities during the period covered by this Form 10-K. 44 ​ Purchases of Equity Securities by the Issuer and Affiliated Purchasers ​ The following table sets forth shares of common stock repurchased under our repurchase program authorized by our Board of Directors in January 2024 (the “2024-2025 Repurchase Program”), as well as shares transferred to us from employees in satisfaction of minimum tax withholding obligations associated with the vesting of performance share units and restricted stock units during the three months ended December 31, 2024: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Period Total number of shares purchased ​ Average Price Paid per Share ​ Total number of shares purchased as part of publicly announced plans or programs (1) ​ Maximum approximate dollar value of Shares that may yet be purchased under the plans or programs (in thousands) October 1, 2024 through October 31, 2024 3,964 ​ $ 36.64 ​ — ​ $ 115,000 November 1, 2024 through November 30, 2024 113,896 ​ ​ 30.79 ​ 111,881 ​ ​ 111,557 December 1, 2024 through December 31, 2024 710,558 ​ ​ 30.44 ​ 708,273 ​ ​ 90,000 Total 828,418 (2) ​ $ 30.52 ​ 820,154 (2) ​ $ 90,000 ​ (1) The 2024-2025 Repurchase Program was announced on January 3, 2024.
Biggest changeRecent Sales of Unregistered Securities There were no unregistered sales of equity securities during the period covered by this Form 10-K. 44 Table of Contents Purchases of Equity Securities by the Issuer and Affiliated Purchasers The following table sets forth shares of common stock repurchased under our repurchase program authorized by our Board of Directors in July 2025 (the “2025-2026 Repurchase Program”), as well as shares transferred to us from employees in satisfaction of minimum tax withholding obligations associated with the vesting of performance share units and restricted stock units during the three months ended December 31, 2025: Period Total number of shares purchased Average Price Paid per Share Total number of shares purchased as part of publicly announced plans or programs (1) Maximum approximate dollar value of Shares that may yet be purchased under the plans or programs (in thousands) October 1, 2025 through October 31, 2025 4,122 $ 32.04 — $ 150,000 November 1, 2025 through November 30, 2025 11,944 46.31 — 150,000 December 1, 2025 through December 31, 2025 3,590 48.86 — 150,000 Total 19,656 (2) $ 43.78 — (2) $ 150,000 (1) The 2025-2026 Repurchase Program was announced on July 1, 2025.
(2) The difference, if any, between the total number of shares purchased and the total number of shares purchased as part of a publicly announced program relates to common stock withheld by us for employees to satisfy their tax withholding obligations arising upon the vesting of performance share units and restricted stock units granted under our Amended and Restated 2014 Stock Incentive Plan. ​ Item 6. [Reserved] ​ ​ 45 ​
(2) The difference, if any, between the total number of shares purchased and the total number of shares purchased as part of a publicly announced program relates to common stock withheld by us for employees to satisfy their tax withholding obligations arising upon the vesting of performance share units and restricted stock units granted under our Amended and Restated 2014 Stock Incentive Plan.
Data for the NASDAQ Composite Index and NASDAQ Biotechnology Index assume reinvestment of dividends, however no dividends have been declared on our common stock to date. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, ​ December 31, $100 investment in stock or index ​ 2019 ​ 2024 Collegium Pharmaceutical, Inc.
Data for the NASDAQ Composite Index and NASDAQ Biotechnology Index assume reinvestment of dividends, however no dividends have been declared on our common stock to date. $100 investment in stock or index December 31, 2020 December 31, 2025 Collegium Pharmaceutical, Inc.
Dividends We have never declared or paid cash dividends on our common stock, and we do not expect to pay any cash dividends on our common stock in the foreseeable future. 43 ​ Stock Performance Graph The following graph sets forth the Company’s total cumulative shareholder return as compared to the NASDAQ Composite Index and the NASDAQ Biotechnology Index for the 5-year period beginning on December 31, 2019 through December 31, 2024.
Dividends We have never declared or paid cash dividends on our common stock, and we do not expect to pay any cash dividends on our common stock in the foreseeable future. 43 Table of Contents Stock Performance Graph The following graph sets forth the Company’s total cumulative shareholder return as compared to the NASDAQ Composite Index and the NASDAQ Biotechnology Index for the 5-year period beginning on December 31, 2020 through December 31, 2025.
Holders As of January 31, 2025, there were 12 holders of record of our common stock. The number of holders of record does not include beneficial owners whose shares are held by nominees in street name.
Holders As of January 31, 2026, there were 11 holders of record of our common stock. The number of holders of record does not include beneficial owners whose shares are held by nominees in street name.
(COLL) ​ $ 100.00 ​ $ 139.21 NASDAQ Composite Index (IXIC) ​ $ 100.00 ​ $ 215.22 NASDAQ Biotechnology Index (NBI) ​ $ 100.00 ​ $ 113.84 ​ The performance graph and related information shall not be deemed to be “soliciting material” or to be “filed” with the SEC, nor shall such information be incorporated by reference into any future filing under the Securities Act, except to the extent that we specifically incorporate it by reference into such filing.
(COLL) $ 100.00 $ 231.15 NASDAQ Composite Index (IXIC) $ 100.00 $ 180.33 NASDAQ Biotechnology Index (NBI) $ 100.00 $ 119.92 The performance graph and related information shall not be deemed to be “soliciting material” or to be “filed” with the SEC, nor shall such information be incorporated by reference into any future filing under the Securities Act, except to the extent that we specifically incorporate it by reference into such filing.
The 2024-2025 Repurchase Program provides for the repurchase of up to $150.0 million of outstanding shares of our common stock at any time or times through June 30, 2025. The 2024-2025 Repurchase Program did not expire during the three months ended December 31, 2024, nor do we currently plan to terminate the 2024-2025 Repurchase Program prior to expiration.
The 2025-2026 Repurchase Program provided for the repurchase of up to $150.0 million of outstanding shares of our common stock at any time or times through December 31, 2026.
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However, there can be no assurance as to the timing or number of shares of any repurchases in the future.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Biggest changeThe $34.2 million increase was primarily due to higher revenues of $64.6 million, partially offset by higher salaries, wages and benefits (excluding stock-based compensation and CEO transition expense) of $14.7 million and higher sales and marketing expenses of $9.5 million. ​ The following is a summary of 2024 quarterly Adjusted EBITDA: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ First Quarter ​ Second Quarter ​ Third Quarter ​ Fourth Quarter ​ (in thousands) GAAP Net income ​ $ 27,713 ​ $ 19,606 ​ $ 9,335 ​ $ 12,536 Adjustments: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Interest expense ​ ​ 17,339 ​ ​ 15,587 ​ ​ 18,394 ​ ​ 22,654 Interest income ​ ​ (4,487) ​ ​ (4,397) ​ ​ (3,280) ​ ​ (1,812) Loss on extinguishment of debt ​ ​ — ​ ​ 7,184 ​ ​ 4,145 ​ ​ — Provision for income taxes ​ ​ 8,909 ​ ​ 9,491 ​ ​ 6,245 ​ ​ 4,733 Depreciation ​ ​ 917 ​ ​ 952 ​ ​ 946 ​ ​ 1,041 Amortization ​ ​ 34,517 ​ ​ 34,515 ​ ​ 40,801 ​ ​ 55,471 Stock-based compensation ​ ​ 7,475 ​ ​ 10,012 ​ ​ 7,317 ​ ​ 7,596 Litigation settlements ​ ​ — ​ ​ — ​ ​ — ​ ​ — Recognition of step-up basis in inventory ​ ​ — ​ ​ — ​ ​ 1,301 ​ ​ 3,968 CEO transition expense ​ ​ — ​ ​ 3,051 ​ ​ — ​ ​ — Acquisition related expenses ​ ​ — ​ ​ — ​ ​ 19,886 ​ ​ 4,443 Gain on fair value remeasurement of contingent consideration ​ ​ — ​ ​ — ​ ​ — ​ ​ (2,914) Total adjustments ​ $ 64,670 ​ $ 76,395 ​ $ 95,755 ​ $ 95,180 Adjusted EBITDA ​ $ 92,383 ​ $ 96,001 ​ $ 105,090 ​ $ 107,716 ​ Adjusted Operating Expenses ​ Adjusted operating expenses is a non-GAAP financial measure that represents GAAP operating expenses adjusted to exclude stock-based compensation expense, and other adjustments to reflect changes that occur in our business but do not represent ongoing operations. ​ 56 ​ Adjusted operating expenses for the years ended December 31, 2024 and 2023 were as follows: ​ ​ ​ ​ ​ ​ ​ ​ Years Ended December 31, ​ 2024 ​ 2023 ​ (in thousands) GAAP operating expenses $ 207,449 ​ $ 159,208 Adjustments: ​ ​ ​ ​ ​ Stock-based compensation ​ 32,400 ​ ​ 27,136 Litigation settlements ​ — ​ ​ 8,500 CEO transition expense ​ 3,051 ​ ​ — Acquisition related expenses ​ 24,329 ​ ​ — Gain on fair value remeasurement of contingent consideration ​ (2,914) ​ ​ — Total adjustments $ 56,866 ​ $ 35,636 Adjusted operating expenses $ 150,583 ​ $ 123,572 ​ Adjusted operating expenses were $150.6 million for 2024 compared to $123.6 million for 2023.
Biggest changeThe following is a summary of 2025 quarterly Adjusted EBITDA: First Quarter Second Quarter Third Quarter Fourth Quarter (in thousands) GAAP Net income $ 2,417 $ 11,983 $ 31,507 $ 16,963 Adjustments: Interest expense 20,790 20,463 21,767 19,292 Interest income (2,225) (2,383) (3,116) (3,565) Loss on extinguishment of debt — — — 15,994 Provision for income taxes 705 5,042 11,929 12,073 Depreciation 1,091 1,135 1,033 923 Amortization 55,473 55,473 55,473 55,473 Stock-based compensation 11,524 10,818 9,811 9,753 Litigation settlements and contingencies — — 3,058 — Recognition of step-up basis in inventory 3,477 1,954 — — Executive transition expense 1,397 — — — Acquisition related expenses 1,289 935 1,552 399 Gain on fair value remeasurement of contingent consideration (786) (358) (19) (19) Total adjustments $ 92,735 $ 93,079 $ 101,488 $ 110,323 Adjusted EBITDA $ 95,152 $ 105,062 $ 132,995 $ 127,286 55 Table of Contents Adjusted Operating Expenses Adjusted operating expenses is a non-GAAP financial measure that represents GAAP operating expenses adjusted to exclude stock-based compensation expense, and other adjustments to reflect changes that occur in our business but do not represent ongoing operations.
(2) Adjusted weighted-average shares - diluted were calculated using the “if-converted” method for the convertibles notes in accordance with ASC 260, Earnings per Share . As such, adjusted weighted-average shares – diluted includes shares related to the assumed conversion of our convertible notes and the associated cash interest expense added-back to non-GAAP adjusted net income.
(2) Adjusted weighted-average shares - diluted were calculated using the “if-converted” method for the convertible notes in accordance with ASC 260, Earnings per Share . As such, adjusted weighted-average shares – diluted includes shares related to the assumed conversion of our convertible notes and the associated cash interest expense added-back to non-GAAP adjusted net income.
Provisions for rebates and incentives are based on the estimated amount of rebates and incentives to be claimed on the related sales from the period. As our rebates and incentives are based on products dispensed to patients, we are required 48 ​ to estimate the expected value of claims at the time of product delivery to distributors.
Provisions for rebates and incentives are based on the estimated amount of rebates and incentives to be claimed on the related sales from the period. As our rebates and incentives are based on products dispensed to patients, we are required to estimate the expected value of claims at the time of product delivery to distributors.
We began shipping and recognizing product revenue related to Belbuca in March 2022 following our acquisition of BioDelivery Sciences International, Inc.
We began shipping and recognizing product revenue related to Belbuca in March 2022 following our acquisition of BioDelivery Sciences International, Inc. (“BDSI”).
We believe the presentation of these non-GAAP financial measures, when viewed with our results under GAAP and the accompanying reconciliations, provide analysts, investors, lenders, and other third parties with insights into how we evaluate normal operational activities, including our ability to generate cash from operations, on a comparable year-over-year basis and manage our budgeting and forecasting.
We believe the presentation of these non-GAAP financial measures, when viewed with our results under GAAP and the accompanying reconciliations, provide analysts, investors, lenders, and other third parties with insights into how we evaluate normal operational activities, including our ability to generate cash from operations, on a 53 Table of Contents comparable year-over-year basis and manage our budgeting and forecasting.
For a discussion of the year ended December 31, 2023 compared to the year ended December 31, 2022, refer to Part II, Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the year ended December 31, 2023.
For a discussion of the year ended December 31, 2024 compared to the year ended December 31, 2023, refer to Part II, Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the year ended December 31, 2024.
Provisions for product returns, including returns for Jornay, Belbuca, Xtampza, the Nucynta Products, and Symproic, are based on product-level returns rates, including processed as well as unprocessed return claims, in addition to relevant market events and other factors.
Provisions for product returns, including returns for Jornay PM, Belbuca, Xtampza ER, the Nucynta Products, and Symproic, are based on product-level returns rates, including processed as well as unprocessed return claims, in addition to relevant market events and other factors.
Our purchase obligations represent the minimum purchase obligations of up to $3.0 million per year with our contract manufacturer which are in effect as of December 31, 2024 and will remain in effect each year until the termination of our manufacturing agreement.
Our purchase obligations represent the minimum purchase obligations of up to $3.0 million per year with our contract manufacturer which are in effect as of December 31, 2025 and will remain in effect each year until the termination of our manufacturing agreement.
(“Ironshore”) (the “Ironshore Acquisition”). ​ Belbuca is a buccal film that contains buprenorphine, a Schedule III opioid, and was approved by the FDA in October 2015 for severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative options are inadequate.
Belbuca is a buccal film that contains buprenorphine, a Schedule III opioid, and was approved by the FDA in October 2015 for severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative options are inadequate.
Symproic 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.
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.
We began shipping and recognizing product revenue related to Symproic in March 2022 following our acquisition of BDSI. ​ 46 ​ Financial Operations Overview Product Revenues Product revenues through the year ended December 31, 2024 were generated from sales of Jornay, Belbuca, Xtampza ER, the Nucynta Products, and Symproic.
We began shipping and recognizing product revenue related to Symproic in March 2022 following our acquisition of BDSI. Financial Operations Overview Product Revenues Product revenues through the year ended December 31, 2025 were generated from sales of Jornay PM, Belbuca, Xtampza ER, the Nucynta Products, and Symproic.
Adjusted EBITDA, as used by us, may be calculated differently from, and therefore may not be comparable to, similarly titled measures used by other companies. ​ There are several limitations related to the use of adjusted EBITDA rather than net income or loss, which is the nearest GAAP equivalent, such as: ​ ● adjusted EBITDA excludes depreciation and amortization, and, although these are non-cash expenses, the assets being depreciated or amortized may have to be replaced in the future, the cash requirements for which are not reflected in adjusted EBITDA; ● adjusted EBITDA does not reflect changes in, or cash requirements for, working capital needs; ● adjusted EBITDA does not reflect the benefit from or provision for income taxes or the cash requirements to pay taxes; ● adjusted EBITDA does not reflect historical cash expenditures or future requirements for capital expenditures or contractual commitments; ● we exclude stock-based compensation expense from adjusted EBITDA although: (i) it has been, and will continue to be for the foreseeable future, a significant recurring expense for our business and an important part of our compensation strategy; and (ii) if we did not pay out a portion of our compensation in the form of stock-based compensation, the cash salary expense included in operating expenses would be higher, which would affect our cash position; ● we exclude impairment expenses from adjusted EBITDA and, although these are non-cash expenses, the asset(s) being impaired may have to be replaced in the future, the cash requirements for which are not reflected in adjusted EBITDA; ● we exclude restructuring expenses from adjusted EBITDA.
There are several limitations related to the use of adjusted EBITDA rather than net income or loss, which is the nearest GAAP equivalent, such as: • adjusted EBITDA excludes depreciation and amortization, and, although these are non-cash expenses, the assets being depreciated or amortized may have to be replaced in the future, the cash requirements for which are not reflected in adjusted EBITDA; • adjusted EBITDA does not reflect changes in, or cash requirements for, working capital needs; • adjusted EBITDA does not reflect the benefit from or provision for income taxes or the cash requirements to pay taxes; • adjusted EBITDA does not reflect historical cash expenditures or future requirements for capital expenditures or contractual commitments; • we exclude stock-based compensation expense from adjusted EBITDA although: (i) it has been, and will continue to be for the foreseeable future, a significant recurring expense for our business and an important part of our compensation strategy; and (ii) if we did not pay out a portion of our compensation in the form of stock-based compensation, the cash salary expense included in operating expenses would be higher, which would affect our cash position; • we exclude impairment expenses from adjusted EBITDA and, although these are non-cash expenses, the asset(s) being impaired may have to be replaced in the future, the cash requirements for which are not reflected in adjusted EBITDA; • we exclude restructuring expenses from adjusted EBITDA.
Our discussion and analysis of our financial condition and results of operations for the year ended Decemebr 31, 2024 as compared to December 31, 2023 are discussed below.
Our discussion and analysis of our financial condition and results of operations for the year ended December 31, 2025 as compared to December 31, 2024 are discussed below.
For the three months ended March 31, June 30, September 30, and December 31, 2024, adjusted weighted-average shares – diluted includes 7,509,104, 6,606,305, 6,606,305, and 6,606,305 shares, respectively, attributable to our convertible notes. In addition, adjusted earnings per share includes other potentially dilutive securities to the extent that they are not antidilutive. ​ ​
For the three months ended March 31, June 30, September 30, and December 31, 2025, adjusted weighted-average shares – diluted includes 6,606,305 shares attributable to our convertible notes. In addition, adjusted earnings per share includes other potentially dilutive securities to the extent that they are not antidilutive.
Actual results may differ from these estimates under different assumptions or conditions. We believe that several accounting policies are important to understanding our historical and future performance.
Actual results may differ from these estimates under different assumptions or conditions. 47 Table of Contents We believe that several accounting policies are important to understanding our historical and future performance.
For the years ended December 31, 2024 and 2023, adjusted weighted-average shares – diluted includes 6,606,305 and 6,793,421 shares, respectively, attributable to our convertible notes.
For the years ended December 31, 2025 and 2024, adjusted weighted-average shares – diluted includes 6,606,305 attributable to our convertible notes.
The effective tax rate was 29.8% and 36.4% for 2024 and 2023, respectively. ​ Liquidity and Capital Resources ​ Sources of Liquidity ​ Historically, we have funded our operations primarily through public offerings of our common stock, private placements of term debt; convertible notes; and cash inflows from sales of our products.
The effective tax rate was 32.1% and 29.8% for 2025 and 2024, respectively. 51 Table of Contents Liquidity and Capital Resources Sources of Liquidity Historically, we have funded our operations primarily through public offerings of our common stock, private placements of term debt; convertible notes; and cash inflows from sales of our products.
Food and Drug Administration (“FDA”) in August 2018 for the treatment of attention deficit hyperactivity disorder (“ADHD”) in people six years of age and older and currently the only FDA-approved stimulant medication that is dosed in the evening. We began recognizing product revenue related to Jornay in September 2024 following our acquisition of Ironshore Therapeutics Inc.
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. We began recognizing product revenue related to Jornay PM in September 2024 following our acquisition of Ironshore Therapeutics Inc. (“Ironshore”) (the “Ironshore Acquisition”).
(“BDSI”). ​ Xtampza ER, an abuse-deterrent, oral formulation of oxycodone, was approved by the FDA in April 2016 for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate.
Xtampza ER, an abuse-deterrent, extended-release, oral formulation of oxycodone, is a Schedule II opioid and was approved by the FDA in April 2016 for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. We commercially launched Xtampza ER in June 2016.
This generally occurs upon delivery to our customers when estimated provisions for chargebacks, rebates, sales incentives and allowances, distribution service fees, and returns are reasonably determinable.
This generally occurs upon delivery to our customers when estimated provisions for chargebacks, rebates, sales incentives and allowances, distribution service fees, and returns are reasonably determinable. Therefore, product sales are recorded upon delivery to our customers net of estimated rebates and incentives, product returns, and trade allowances and chargebacks.
Therefore, product sales are recorded upon delivery to our customers net of estimated rebates and incentives, product returns, and trade allowances and chargebacks. ​ Sales Deductions ​ Sales deductions consist primarily of provisions for: (i) rebates and incentives, including managed care rebates, government rebates, co-pay program incentives, and sales incentives and allowances; (ii) product returns, including return estimates for our products; and (iii) trade allowances and chargebacks, including fees for distribution service fees, prompt pay discounts, and chargebacks.
Sales Deductions Sales deductions consist primarily of provisions for: (i) rebates and incentives, including managed care rebates, government rebates, co-pay program incentives, and sales incentives and allowances; (ii) product returns, including return estimates for our products; and (iii) trade allowances and chargebacks, including fees for distribution service fees, prompt pay discounts, and chargebacks.
In addition, in 2024, assumed debt from the Ironshore Acquisition was redeemed, resulting in a loss on extinguishment of $4.1 million in 2024. ​ Income Taxes ​ The provision for income taxes was $29.4 million for 2024, compared to $27.6 million for 2023.
In addition, in 2024, assumed debt from the Ironshore Acquisition was extinguished, resulting in a loss on extinguishment of $4.1 million. Income Taxes The provision for income taxes was $29.7 million for 2025, compared to $29.4 million for 2024.
Accruals and related reserves are adjusted as new information becomes available, which generally consists of actual trade allowances and chargebacks processed. Actual results may differ from these estimates under different assumptions or conditions.
Provisions for trade allowances and chargebacks are primarily based on customer-level contractual terms. Accruals and related reserves are adjusted as new information becomes available, which generally consists of actual trade allowances and chargebacks processed. Actual results may differ from these estimates under different assumptions or conditions.
Cash used in financing activities was $60.6 million in 2024, compared to $140.2 million in 2023.
Cash used in financing activities was $110.2 million in 2025, compared to $60.6 million in 2024.
The blended federal and state statutory rate for the years ended December 31, 2024 and 2023 were 26.5% and 25.9%, respectively. As such, the non-GAAP effective tax rates for the years ended December 31, 2024 and 2023 were 25.3% and 23.4%, respectively.
The blended federal and state statutory rate for the years ended December 31, 2025 and 2024 were 24.8% and 26.5%, respectively. As such, the non-GAAP effective tax rates for the years ended December 31, 2025 and 2024 were 24.0% and 25.3%, respectively.
As of December 31, 2024, $90 million remained available for share repurchases under the 2024-2025 Repurchase Program .
As of December 31, 2025, $150.0 million remained available for share repurchases under the 2025-2026 Repurchase Program.
Restructuring expenses primarily include employee severance and contract termination costs that are not related to acquisitions. The amount and/or frequency of these restructuring expenses are not part of our underlying business; ● we exclude litigation settlements from adjusted EBITDA, as well as any applicable income items or credit adjustments due to subsequent changes in estimates.
The amount and/or frequency of these restructuring expenses are not part of our underlying business; • we exclude litigation settlements and contingencies that are subject to recovery from adjusted EBITDA, as well as any applicable income items, credit adjustments, or recoveries due to subsequent changes in estimates.
The blended federal and state statutory rate for the three months ended March 31, June 30, September 30, and December 31, 2024 were 26.6%, 25.9%, 28.1%, and 25.3%, respectively. As such, the non-GAAP effective tax rates for the three months ended March 31, June 30, September 30, and December 31, 2024 were 28.9%, 21.3%, 27.9%, and 23.5%, respectively.
The blended federal and state statutory rate for the three months ended March 31, June 30, September 30, and December 31, 2025 were 25.8%, 25.7%, 21.8%, and 25.5%, respectively. As such, the non-GAAP effective tax rates for the three months ended March 31, June 30, September 30, and December 31, 2025 were 25.4%, 25.5%, 21.7%, and 23.6%, respectively.
For further detail regarding our term notes and convertible senior notes, refer to Note 14, Debt. For further detail regarding our deferred royalty obligation, refer to Note 15, Deferred Royalty Obligation. For further detail regarding our operating lease obligations, refer to Note 16, Leases .
For further detail regarding our deferred royalty obligation, refer to Note 15, Deferred Royalty Obligation. For further detail regarding our operating lease obligations, refer to Note 16, Leases .
Acquisition related expenses include transaction costs, which primarily consisted of financial advisory, banking, legal, and regulatory fees, and other consulting fees, incurred to complete the acquisition, employee-related expenses (severance cost and benefits) for terminated employees after the acquisition, and miscellaneous other acquisition related expenses incurred; ● we exclude recognition of the step-up basis in inventory from acquisitions (i.e., the adjustment to record inventory from historic cost to fair value at acquisition) as the adjustment does not reflect the ongoing expense associated with sale of our products as part of our underlying business; ● we exclude losses on extinguishments of debt as these expenses are episodic in nature and do not directly correlate to the cost of operating our business on an ongoing basis; and ● we exclude other expenses, from time to time, that are episodic in nature and do not directly correlate to the cost of operating our business on an ongoing basis. ​ 55 ​ Adjusted EBITDA for the years ended December 31, 2024 and 2023 was as follows: ​ ​ ​ ​ ​ ​ ​ ​ Years Ended December 31, ​ 2024 ​ 2023 ​ (in thousands) GAAP net income $ 69,190 ​ $ 48,155 Adjustments: ​ ​ ​ ​ ​ Interest expense ​ 73,974 ​ ​ 83,339 Interest income ​ (13,976) ​ ​ (15,615) Loss on extinguishment of debt ​ 11,329 ​ ​ 23,504 Provision for income taxes ​ 29,378 ​ ​ 27,578 Depreciation ​ 3,856 ​ ​ 3,496 Amortization ​ 165,304 ​ ​ 145,760 Stock-based compensation ​ 32,400 ​ ​ 27,136 Litigation settlements ​ — ​ ​ 8,500 Recognition of step-up basis in inventory ​ 5,269 ​ ​ 15,116 CEO transition expense ​ 3,051 ​ ​ — Acquisition related expenses ​ 24,329 ​ ​ — Gain on fair value remeasurement of contingent consideration ​ (2,914) ​ ​ — Total adjustments $ 332,000 ​ $ 318,814 Adjusted EBITDA $ 401,190 ​ $ 366,969 ​ Adjusted EBITDA was $401.2 million for 2024 compared to $367.0 million for 2023.
Acquisition related expenses include transaction costs, which primarily consisted of financial advisory, banking, legal, and regulatory fees, and other consulting fees, incurred to complete the acquisition, employee-related expenses (severance cost and benefits) for terminated employees after the acquisition, legal defense expenses for specific acquired claims that relate to acts that occurred prior to our acquisition, and miscellaneous other acquisition related expenses incurred; • we exclude recognition of the step-up basis in inventory from acquisitions (i.e., the adjustment to record inventory from historic cost to fair value at acquisition) as the adjustment does not reflect the ongoing expense associated with sale of our products as part of our underlying business; • we exclude losses on extinguishments of debt as these expenses are episodic in nature and do not directly correlate to the cost of operating our business on an ongoing basis; • we exclude executive transition expenses from adjusted EBITDA as the amount and/or frequency of these expenses are episodic in nature and do not directly correlate to the cost of operating our business on an ongoing basis; and • we exclude other expenses, from time to time, that are episodic in nature and do not directly correlate to the cost of operating our business on an ongoing basis. 54 Table of Contents Adjusted EBITDA for the years ended December 31, 2025 and 2024 was as follows: Years Ended December 31, 2025 2024 (in thousands) GAAP net income $ 62,870 $ 69,190 Adjustments: Interest expense 82,312 73,974 Interest income (11,289) (13,976) Loss on extinguishment of debt 15,994 11,329 Provision for income taxes 29,749 29,378 Depreciation 4,182 3,856 Amortization 221,892 165,304 Stock-based compensation 41,906 32,400 Litigation settlements and contingencies 3,058 — Recognition of step-up basis in inventory 5,431 5,269 Executive transition expense 1,397 3,051 Acquisition related expenses 4,175 24,329 Gain on fair value remeasurement of contingent consideration (1,182) (2,914) Total adjustments $ 397,625 $ 332,000 Adjusted EBITDA $ 460,495 $ 401,190 Adjusted EBITDA was $460.5 million for 2025 compared to $401.2 million for 2024.
Cash provided by operating activities was $205.0 million in 2024, compared to $274.7 million in 2023.
Cash provided by operating activities was $329.3 million in 2025, compared to $205.0 million in 2024.
We have maintained a valuation allowance on the portion of our deferred tax assets that are not more likely than not to be realized due to tax limitation or other conditions of $6.5 million as of December 31, 2024.
We have maintained a valuation allowance on the portion of our deferred tax assets that are not more likely than not to be realized due to tax limitation or other conditions of $5.3 million as of December 31, 2025. 49 Table of Contents Results of Operations In this section, we discuss the results of our operations for the year ended December 31, 2025 compared to the year ended December 31, 2024.
These costs have historically been expensed as incurred. As of April 1, 2022, we focused entirely on commercial products rather than research and development and redirected resources from research and development activities.
These costs have historically been expensed as incurred. As of April 1, 2022, we focused entirely on commercial products rather than research and development and redirected resources from research and development activities. As such, there were no expenses incurred in research and development after the three months ended March 31, 2022.
Research and Development Expenses Research and development expenses have historically consisted of product development expenses incurred in identifying, developing, and testing product candidates including stock-based compensation; costs associated with conducting our clinical and non-clinical activities, including clinical and non-clinical trials that we conduct for post-marketing requirements; and costs for laboratory supplies, depreciation of lab equipment, and other expenses including allocated expenses for rent and maintenance of facilities.
Refer to Note 5, License Agreements , and Note 11, Goodwill and Intangible Assets, for further detail around the intangible assets acquired from the Ironshore Acquisition, the BDSI Acquisition, the Nucynta Intangible Asset, and royalty expenses. 46 Table of Contents Research and Development Expenses Research and development expenses have historically consisted of product development expenses incurred in identifying, developing, and testing product candidates including stock-based compensation; costs associated with conducting our clinical and non-clinical activities, including clinical and non-clinical trials that we conduct for post-marketing requirements; and costs for laboratory supplies, depreciation of lab equipment, and other expenses including allocated expenses for rent and maintenance of facilities.
The $12.2 million decrease was due to 2023 including a $23.5 million loss on extinguishment resulting from the repurchase of $117.4 million of the 2026 Convertible Notes in 2023. In 2024, the remaining $26.4 million of the 2026 Convertible Notes were redeemed, resulting in a $7.2 million loss on extinguishment in 2024.
The $4.7 million increase was due to 2025 including a $16.0 million loss on extinguishment resulting from the repayment of the 2024 Term Loan. In 2024, the remaining $26.4 million of the 2026 Convertible Notes were redeemed, resulting in a $7.2 million loss on extinguishment.
The cash flow projections are based on management’s estimates of economic and market conditions including the estimated future cash flows from revenues of acquired assets, the timing and projection of costs and expenses and the related profit margins, tax rates, and an appropriate discount rate. ​ During the measurement period, which occurs before finalization of the purchase price allocation, changes in assumptions and estimates that result in adjustments to the fair values of assets acquired and liabilities assumed, if based on facts and circumstances existing at the acquisition date, are recorded on a retroactive basis as of the acquisition date, with the corresponding offset to goodwill.
During the measurement period, which occurs before finalization of the purchase price allocation, changes in assumptions and estimates that result in adjustments to the fair values of assets acquired and liabilities assumed, if based on facts and circumstances existing at the acquisition date, are recorded on a retroactive basis as of the acquisition date, with the corresponding offset to goodwill.
Adjusted weighted-average shares - diluted is calculated in accordance with the treasury stock, if-converted, or contingently issuable accounting methods, depending on the nature of the security. ​ 57 ​ Adjusted net income and adjusted earnings per share for the years ended December 31, 2024 and 2023 were as follows: ​ ​ ​ ​ ​ ​ ​ ​ Years Ended December 31, ​ 2024 ​ 2023 ​ (in thousands, except share and per share data) GAAP net income $ 69,190 ​ $ 48,155 Adjustments: ​ ​ ​ ​ ​ Non-cash interest expense ​ 9,729 ​ ​ 8,635 Loss on extinguishment of debt ​ 11,329 ​ ​ 23,504 Amortization ​ 165,304 ​ ​ 145,760 Stock-based compensation ​ 32,400 ​ ​ 27,136 Litigation settlements ​ — ​ ​ 8,500 Recognition of step-up basis in inventory ​ 5,269 ​ ​ 15,116 CEO transition expense ​ 3,051 ​ ​ — Acquisition related expenses ​ 24,329 ​ ​ — Gain on fair value remeasurement of contingent consideration ​ (2,914) ​ ​ — Income tax effect of above adjustments (1) ​ (62,880) ​ ​ (53,526) Total adjustments $ 185,617 ​ $ 175,125 Non-GAAP adjusted net income $ 254,807 ​ $ 223,280 ​ ​ ​ ​ ​ ​ Adjusted weighted-average shares — diluted (2) ​ 40,424,180 ​ ​ 41,788,125 Adjusted earnings per share (2) $ 6.45 ​ $ 5.47 ​ (1) The income tax effect of the adjustments was calculated by applying our blended federal and state statutory rate to the adjustments that have a tax effect.
Adjusted net income and adjusted earnings per share for the years ended December 31, 2025 and 2024 were as follows: Years Ended December 31, 2025 2024 (in thousands, except share and per share data) GAAP net income $ 62,870 $ 69,190 Adjustments: Non-cash interest expense 5,341 9,729 Loss on extinguishment of debt 15,994 11,329 Amortization 221,892 165,304 Stock-based compensation 41,906 32,400 Litigation settlements and contingencies 3,058 — Recognition of step-up basis in inventory 5,431 5,269 Executive transition expense 1,397 3,051 Acquisition related expenses 4,175 24,329 Gain on fair value remeasurement of contingent consideration (1,182) (2,914) Income tax effect of above adjustments (1) (71,599) (62,880) Total adjustments $ 226,413 $ 185,617 Non-GAAP adjusted net income $ 289,283 $ 254,807 Adjusted weighted-average shares — diluted (2) 39,701,693 40,424,180 Adjusted earnings per share (2) $ 7.42 $ 6.45 (1) The income tax effect of the adjustments was calculated by applying our blended federal and state statutory rate to the adjustments that have a tax effect.
In addition, certain non-GAAP financial measures, primarily Adjusted EBITDA, are used to measure performance when determining components of annual compensation for substantially all non-sales force employees, including senior management. ​ 54 ​ We may discuss the following financial measures that are not calculated in accordance with GAAP in our quarterly and annual reports, earnings press releases and conference calls. ​ Adjusted EBITDA ​ Adjusted EBITDA is a non-GAAP financial measure that represents GAAP net income or loss adjusted to exclude interest expense, interest income, the benefit from or provision for income taxes, depreciation, amortization, stock-based compensation, and other adjustments to reflect changes that occur in our business but do not represent ongoing operations.
In addition, certain non-GAAP financial measures, primarily Adjusted EBITDA, are used to measure performance when determining components of annual compensation for substantially all non-sales force employees, including senior management. We may discuss the following financial measures that are not calculated in accordance with GAAP in our quarterly and annual reports, earnings press releases and conference calls.
Future share repurchases will depend upon, among other factors, our cash balances and potential future capital requirements, our results of operations and financial conditions, the price of our common stock on the Nasdaq Global Select Market, and other factors that we may deem relevant. ​ Contractual Obligations Our contractual obligations as of December 31, 2024 that will affect our future liquidity include our term loan, including interest; convertible senior notes, including interest; operating lease obligations; deferred royalty obligation, and purchase obligations.
Future share repurchases will depend upon, among other factors, our cash balances and potential future capital requirements, our results of operations and financial conditions, the price of our common stock on the Nasdaq Global Select Market, and other factors that we may deem relevant.
The $1.6 million decrease was primarily due to lower interest rates earned on cash equivalents and marketable securities as well as a lower overall average balance invested in 2024 compared to 2023. ​ Loss on extinguishment of debt ​ Loss on extinguishment of debt was $11.3 million for 2024, compared to $23.5 million for 2023.
The $2.7 million decrease was primarily due to lower interest rates earned on cash equivalents and marketable securities in 2025 compared to 2024. Loss on extinguishment of debt Loss on extinguishment of debt was $16.0 million for 2025, compared to $11.3 million for 2024.
Any adjustments not based on facts and circumstances existing at the acquisition date, or if subsequent to the conclusion of the measurement period, will be recorded to our consolidated statements of operations. ​ 49 ​ Intangible Assets We record the fair value of acquired finite-lived intangible assets as of the transaction date.
Any adjustments not based on facts and circumstances existing at the acquisition date, or if subsequent to the conclusion of the measurement period, will be recorded to our consolidated statements of operations. Income Taxes We utilize the asset and liability method of accounting for income taxes.
These payments are contingent upon the occurrence of various future events, and the amounts payable under these provisions depend upon the level of compensation at the time of termination of employment, and therefore, are not calculable at this time. ​ Non-GAAP Financial Measures ​ To supplement our financial results presented on a GAAP basis, we have included information about certain non-GAAP financial measures.
These payments are contingent upon the occurrence of various future events, and the amounts payable under these provisions depend upon the level of compensation at the time of termination of employment, and therefore, are not calculable at this time.
We have developed, licensed, and acquired a portfolio of meaningfully differentiated products for use in the treatment of moderate to severe pain and attention deficit hyperactivity disorder (“ADHD”), consisting of Jornay PM (“Jornay”), Belbuca, Xtampza ER, Nucynta ER and Nucynta IR (collectively the “Nucynta Products”), and Symproic, in the United States. ​ Jornay is a central nervous system (“CNS”) stimulant prescription medicine that contains methylphenidate HCl, 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. 45 Table of Contents 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.
We began shipping and recognizing product revenue on the Nucynta Products in January 2018 and began marketing the Nucynta Products in February 2018. In August 2023, the FDA granted New Patient Population exclusivity in pediatrics for Nucynta IR.
We began shipping and recognizing product revenue on the Nucynta Products in January 2018 and began marketing the Nucynta Products in February 2018. In August 2023, the FDA granted New Patient Population exclusivity for Nucynta IR in pediatric patients. This grant extended the period of U.S. exclusivity for Nucynta IR from June 27, 2025 to July 3, 2026.
Results of Operations In this section, we discuss the results of our operations for the year ended December 31, 2024 compared to the year ended December 31, 2023. 50 ​ Comparison of the Years Ended December 31, 2024 and 2023 The following table summarizes the results of our operations for the years ended December 31, 2024 and 2023: ​ ​ ​ ​ ​ ​ ​ Years Ended December 31, ​ 2024 ​ 2023 ​ (in thousands) Product revenues, net $ 631,449 $ 566,767 Cost of product revenues ​ ​ ​ ​ ​ Cost of product revenues (excluding intangible asset amortization) ​ 88,801 ​ ​ 94,838 Intangible asset amortization and impairment ​ 165,304 ​ ​ 145,760 Total cost of products revenues ​ 254,105 ​ ​ 240,598 Gross profit ​ 377,344 ​ ​ 326,169 Operating expenses ​ ​ ​ ​ ​ Selling, general and administrative 210,363 ​ 159,208 Gain on fair value remeasurement of contingent consideration ​ (2,914) ​ ​ — Total operating expenses 207,449 ​ 159,208 Income from operations 169,895 ​ 166,961 Interest expense (73,974) ​ (83,339) Interest income ​ 13,976 ​ ​ 15,615 Loss on extinguishment of debt ​ (11,329) ​ ​ (23,504) Income before income taxes ​ 98,568 ​ ​ 75,733 Provision for income taxes ​ 29,378 ​ ​ 27,578 Net income $ 69,190 ​ $ 48,155 ​ Product revenues, net ​ Product revenues, net were $631.4 million for the year ended December 31, 2024 (“2024”), compared to $566.8 million for the year ended December 31, 2023 (“2023”), representing a $64.6 million increase.
Comparison of the Years Ended December 31, 2025 and 2024 The following table summarizes the results of our operations for the years ended December 31, 2025 and 2024: Years Ended December 31, 2025 2024 (in thousands) Product revenues, net $ 780,567 $ 631,449 Cost of product revenues Cost of product revenues (excluding intangible asset amortization) 95,418 88,801 Intangible asset amortization 221,892 165,304 Total cost of product revenues 317,310 254,105 Gross profit 463,257 377,344 Operating expenses Selling, general and administrative 284,803 210,363 Gain on fair value remeasurement of contingent consideration (1,182) (2,914) Total operating expenses 283,621 207,449 Income from operations 179,636 169,895 Interest expense (82,312) (73,974) Interest income 11,289 13,976 Loss on extinguishment of debt (15,994) (11,329) Income before income taxes 92,619 98,568 Provision for income taxes 29,749 29,378 Net income $ 62,870 $ 69,190 Product revenues, net Product revenues, net were $780.6 million for the year ended December 31, 2025 (“2025”), compared to $631.4 million for the year ended December 31, 2024 (“2024”), representing a $149.2 million increase.
To determine whether the acquisitions should be accounted for as business combinations or as asset acquisitions, we made certain judgments regarding whether the acquired set of activities and assets met the definition of a business.
Business Combination Accounting and Valuation of Acquired Assets We completed the Ironshore Acquisition in September 2024, which was accounted for as a business combination. To determine whether the acquisition should be accounted for as a business combination or as an asset acquisition, we make judgments regarding whether the acquired set of activities and assets met the definition of a business.
As of December 31, 2024, the outstanding principal balance of the Convertible Notes was $241.5 million, which is due in 2029.
As of December 31, 2025, the outstanding principal balance of the 2025 Term Loan was $580.0 million, of which $29.0 million in principal payments are due within the next 12 months. As of December 31, 2025, the outstanding principal balance of the 2029 Convertible Notes was $241.5 million.
The $217.0 million increase in cash used in investing activities was primarily due to $267.5 million cash paid to acquire Ironshore (net of cash acquired) and $18.8 million increase in purchases of marketable securities, partially offset by $70.6 million increase in maturities of marketable securities. Financing activities.
Cash used in investing activities was $63.5 million in 2025, compared to $287.8 million in 2024. The $224.3 million decrease in cash used in investing activities was primarily due 2024 including $267.5 million of cash used to acquire Ironshore (net of cash acquired), partially offset by a $43.2 million increase in cash used in investing in marketable securities. Financing activities.
As such, there were no expenses incurred in research and development after the three months ended March 31, 2022. ​ Selling, General and Administrative Expenses Selling, general and administrative expenses consist primarily of salaries and employee-related costs, including stock-based compensation and travel expenses for our employees.
Selling, General and Administrative Expenses Selling, general and administrative expenses consist primarily of salaries and employee-related costs, including stock-based compensation and travel expenses for our employees.
We update the measurement of the refund liability at the end of each reporting period for changes in expectations about the amount of refunds with the corresponding adjustments recognized as revenue (or reductions of revenue).
We update the measurement of the refund liability at the end of each reporting period for changes in expectations about the amount of refunds with the corresponding adjustments recognized as revenue (or reductions of revenue). 48 Table of Contents We provide the right of return to our customers for an 18-month window beginning six months prior to expiration and up until twelve months after expiration.
The $51.2 million increase was primarily related to: ● an increase in acquisition related expense of $24.3 million due to the Ironshore Acquisition; ● an increase in salaries, wages and benefits of $23.1 million primarily due to additional headcount added in September 2024 as a result of the Ironshore Acquisition, including the sales force that promotes Jornay, as well as expenses incurred as a result of the CEO transition announced in May 2024, including higher stock-based compensation expense of $3.7 million related to accelerated equity awards and higher severance, benefits, and related expenses incurred of $3.1 million; ● an increase in sales and marketing expenses of $9.5 million, primarily due to expenses incurred to support the ongoing commercialization of Jornay following the Ironshore Acquisition in September 2024; ● an increase in regulatory fees of $1.8 million primarily due to fees incurred for Jornay following the Ironshore Acquisition in September 2024; partially offset by ● an overall decrease in audit and legal expenses of $9.5 million, primarily due to an $8.5 million litigation settlement during 2023 and lower litigation related expenses. ​ Interest expense and Interest income ​ Interest expense was $74.0 million for 2024, compared to $83.3 million for 2023.
The $74.4 million increase was primarily related to: • an increase in salaries, wages and benefits of $49.4 million primarily due to additional headcount added in 2025 as a result of the Ironshore Acquisition, including the expansion of the sales force that promotes Jornay PM in 2025, as well as expenses incurred as a result of certain executive transitions announced in 2025, including stock-based compensation expense of $2.6 million related to accelerated equity awards and severance, benefits, and related expenses incurred of $1.4 million; • an increase in sales and marketing expenses of $37.6 million, primarily due to expenses incurred to support Jornay PM following the Ironshore Acquisition in September 2024; and • an increase in audit and legal expenses of $4.9 million primarily due to expenses related to litigation; partially offset by: • a decrease in acquisition related expenses of $20.1 million, as 2024 included transaction costs and other expenses incurred shortly after the Ironshore Acquisition that did not recur at the same level in 2025.
We provide the right of return to our customers for an 18-month window beginning six months prior to expiration and up until twelve months after expiration. Our customers short-pay an existing invoice upon notice of a product return claim. Adjustments to the preliminary short-paid claims are processed when the return claim is validated and finalized.
Our customers short-pay an existing invoice upon notice of a product return claim. Adjustments to the preliminary short-paid claims are processed when the return claim is validated and finalized. Our return policy requires that product is returned and that the return is claimed within the 18-month window. Refer to Note 3, Revenue from Contracts with Customers , for more information.
As of December 31, 2024, and December 31, 2023, we had $70.6 million and $238.9 million in cash and cash equivalents, respectively. ​ Although our current assets of $482.3 million and current liabilities of $508.1 million resulted in a working capital deficit as of December 31, 2024, we believe that our cash, cash equivalents, and marketable securities as of December 31, 2024, together with expected cash inflows from operations, will enable us to fund our operating expenses, debt service and capital expenditure requirements under our current business plan for the foreseeable future. ​ Borrowing Arrangements and Equity Offerings ​ The following transactions represent our material borrowing arrangements and equity offerings: the 2024 Term Loan, and the 2029 Convertible Notes.
We believe that our cash, cash equivalents, and marketable securities as of December 31, 2025, together with expected cash inflows from operations, will enable us to fund our operating expenses, debt service and capital expenditure requirements under our current business plan for the foreseeable future.
As we continue to invest in the commercialization of our products, we expect our selling, general and administrative expenses to continue to be substantial for the foreseeable future.
As we continue to invest in the commercialization of our products, we expect our selling, general and administrative expenses to continue to be substantial for the foreseeable future. Interest Expense Interest expense consists primarily of cash and non-cash interest costs related to our debt, including term loans, delayed draw term loans, a revolving credit facility, and convertible notes.
Refer to Note 14, Debt , for more information. ​ Cash flows ​ In this section, we discuss cash flows for the year ended December 31, 2024 compared to the year ended December 31, 2023. ​ ​ ​ ​ ​ ​ ​ Years Ended December 31, ​ 2024 ​ 2023 ​ (in thousands) Net cash provided by operating activities $ 204,980 $ 274,749 Net cash used in investing activities (287,759) ​ (70,812) Net cash (used in) provided by financing activities (60,603) ​ (140,178) Net (decrease) increase in cash, cash equivalents and restricted cash $ (143,382) ​ $ 63,759 ​ Operating activities.
Years Ended December 31, 2025 2024 (in thousands) Net cash provided by operating activities $ 329,323 $ 204,980 Net cash used in investing activities (63,532) (287,759) Net cash used in financing activities (110,245) (60,603) Net increase (decrease) in cash, cash equivalents and restricted cash $ 155,546 $ (143,382) Operating activities.
We commercially launched Xtampza ER in June 2016. ​ The Nucynta Products are extended-release (“ER”) and immediate-release (“IR”) formulations of tapentadol.
The Nucynta Products are extended-release (“ER”) and immediate-release (“IR”) oral formulations of tapentadol, a Schedule II opioid. In November 2008, the FDA approved Nucynta ER and Nucynta IR.
However, we are subject to all the risks common to the commercialization and development of new pharmaceutical products, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business. ​ We have significant future capital requirements, including: ● expected operating expenses to manufacture and commercialize our products and to operate our organization; ● repayment of outstanding principal amounts and interest in connection with our 2024 Term Loan and 2029 Convertible Notes; ● royalties we pay on sales of certain products within our portfolio; ● payment of income taxes; ● deferred royalty obligation in connection with Jornay; ● operating lease obligations; ● minimum purchase obligations in connection with our contract manufacturer; and ● contingent payment upon the achievement of a financial milestone based on net revenues of Jornay. ​ In addition, we have significant potential future capital requirements, including: ● we may enter into business development transactions, including acquisitions, collaborations, licensing arrangements and equity investments, that require additional capital; ● any judgements rendered against us in connection with any of the litigation matters set forth in Note 13, Commitments and Contingencies , to our financial statements; and ● in January 2024, our Board of Directors authorized a share repurchase program for the repurchase of up to $150.0 million of shares of our common stock through June 30, 2025.
We have significant future capital requirements, including: • expected operating expenses to manufacture and commercialize our products and to operate our organization; • repayment of outstanding principal amounts and interest in connection with our 2025 Term Loan and 2029 Convertible Notes; • royalties we pay on sales of certain products within our portfolio; • payment of income taxes; • deferred royalty obligation in connection with Jornay PM; • operating lease obligations; • minimum purchase obligations in connection with our contract manufacturer; and • contingent payment upon the achievement of a financial milestone based on net revenues of Jornay PM.
In addition, adjusted earnings per share includes other potentially dilutive securities to the extent that they are not antidilutive. ​ 58 ​ The following is a summary of 2024 quarterly adjusted net income and adjusted earnings per share: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ First Quarter ​ Second Quarter ​ Third Quarter ​ Fourth Quarter ​ (in thousands, except share and per share data) GAAP net income $ 27,713 ​ $ 19,606 ​ $ 9,335 ​ $ 12,536 Adjustments: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Non-cash interest expense ​ 1,780 ​ ​ 1,604 ​ ​ 1,681 ​ ​ 4,664 Loss on extinguishment of debt ​ — ​ ​ 7,184 ​ ​ 4,145 ​ ​ — Amortization ​ 34,517 ​ ​ 34,515 ​ ​ 40,801 ​ ​ 55,471 Stock-based compensation ​ 7,475 ​ ​ 10,012 ​ ​ 7,317 ​ ​ 7,596 Recognition of step-up basis in inventory ​ — ​ ​ — ​ ​ 1,301 ​ ​ 3,968 CEO transition expense ​ — ​ ​ 3,051 ​ ​ — ​ ​ — Acquisition related expenses ​ — ​ ​ — ​ ​ 19,886 ​ ​ 4,443 Gain on fair value remeasurement of contingent consideration ​ — ​ ​ — ​ ​ — ​ ​ (2,914) Income tax effect of above adjustments (1) ​ (12,653) ​ ​ (12,008) ​ ​ (20,974) ​ ​ (17,245) Total adjustments $ 31,119 ​ $ 44,358 ​ $ 54,157 ​ $ 55,983 Non-GAAP adjusted net income $ 58,832 ​ $ 63,964 ​ $ 63,492 ​ $ 68,519 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Adjusted weighted-average shares — diluted (2) ​ 41,438,466 ​ ​ 40,383,695 ​ ​ 40,163,266 ​ ​ 40,109,649 Adjusted earnings per share (2) $ 1.45 ​ $ 1.62 ​ $ 1.61 ​ $ 1.77 ​ (1) The income tax effect of the adjustments was calculated by applying our blended federal and state statutory rate to the adjustments that have a tax effect.
In addition, adjusted earnings per share includes other potentially dilutive securities to the extent that they are not antidilutive. 57 Table of Contents The following is a summary of 2025 quarterly adjusted net income and adjusted earnings per share: First Quarter Second Quarter Third Quarter Fourth Quarter (in thousands, except share and per share data) GAAP net income $ 2,417 $ 11,983 $ 31,507 $ 16,963 Adjustments: Non-cash interest expense 1,367 1,355 1,343 1,276 Loss on extinguishment of debt — — — 15,994 Amortization 55,473 55,473 55,473 55,473 Stock-based compensation 11,524 10,818 9,811 9,753 Litigation settlements and contingencies — — 3,058 — Recognition of step-up basis in inventory 3,477 1,954 — — Executive transition expense 1,397 — — — Acquisition related expenses 1,289 935 1,552 399 Gain on fair value remeasurement of contingent consideration (786) (358) (19) (19) Income tax effect of above adjustments (1) (18,737) (17,871) (15,453) (19,538) Total adjustments $ 55,004 $ 52,306 $ 55,765 $ 63,338 Non-GAAP adjusted net income $ 57,421 $ 64,289 $ 87,272 $ 80,301 Adjusted weighted-average shares — diluted (2) 39,446,458 39,075,703 39,439,890 40,076,457 Adjusted earnings per share (2) $ 1.49 $ 1.68 $ 2.25 $ 2.04 (1) The income tax effect of the adjustments was calculated by applying our blended federal and state statutory rate to the adjustments that have a tax effect.
The $64.6 million increase is primarily due to increases in revenue for Jornay of $37.2 million, Belbuca of $29.2 million, and Xtampza ER of $14.0 million, partially offset by decreases in revenue for the Nucynta Products of $14.3 million and Symproic of $1.4 million. ​ The increase in revenue for Jornay of $37.2 million is due to the acquisition of the product from Ironshore in 2024. ​ The increase in revenue for Belbuca of $29.2 million is primarily due to higher sales volume, gross price, and lower gross-to-net adjustments related to provisions for rebates, partially offset by higher gross-to-net adjustments related to provisions for chargebacks. ​ The increase in revenue for Xtampza ER of $14.0 million is primarily due to lower gross-to-net adjustments related to provisions for rebates and higher gross price, partially offset by lower sales volume. ​ The decrease in revenue for the Nucynta Products of $14.3 million is primarily due to lower sales volume and higher gross-to-net adjustments related to provisions for rebates, partially offset by higher gross price. ​ Cost of product revenues ​ Cost of product revenues (excluding intangible asset amortization) was $88.8 million for 2024, compared to $94.8 million for 2023.
The increase in revenue for the Nucynta Products of $19.8 million was primarily due to lower gross-to-net adjustments related to provisions for rebates and higher gross price, partially offset by lower sales volume.
These decreases were partially offset by increases in cash flow from operating results, which reflects operating earnings, after adjustment for non-cash items that are included in net income. ​ Investing activities. Cash used in investing activities was $287.8 million in 2024, compared to $70.8 million in 2023.
The $124.3 million increase in cash provided by operating activities was primarily due to the increase in cash flow from operating results after adjustment for non-cash items that are included in net income as well as due to changes in working capital, which were significantly impacted by the payment of assumed liabilities from Ironshore in 2024. Investing activities.
Overview ​ We are building a leading, diversified biopharmaceutical company committed to improving the lives of people living with serious medical conditions.
Overview Our mission is to build a leading, diversified biopharmaceutical company committed to improving the lives of people living with serious medical conditions. 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.
The $79.6 million decrease was primarily due to: ● an increase in proceeds received from the modification of term loans of $313.2 million; ● a decrease in repayments of term notes of $54.7 million; ● a decrease in cash used to repurchase common stock of $15.0 million; ● an increase in cash provided from stock option exercises of $1.6 million; partially offset by ● the payoff of assumed debt from Ironshore of $164.6 million in 2024; ● the repurchase of a portion of our 2026 Convertible Notes and issuance of our 2029 Convertible Notes which resulted in net proceeds of $96.6 million in 2023; ● the $33.2 million cash settlement of the remaining 2026 Convertible Notes in 2024; and ● an increase in payments for employee stock tax withholdings of $10.8 million. ​ 53 ​ Funding requirements We believe that our cash, cash equivalents, and marketable securities as of December 31, 2024, together with expected cash inflows from operations, will enable us to fund our operating expenses, debt service and capital expenditure requirements under our current business plan for the foreseeable future.
Funding requirements We believe that our cash, cash equivalents, and marketable securities as of December 31, 2025, together with expected cash inflows from operations, will enable us to fund our operating expenses, debt service and capital expenditure requirements under our current business plan for the foreseeable future.
The $27.0 million increase was primarily driven by: ● an increase in salaries, wages, and benefits (excluding stock-based compensation and CEO transition expense) of $14.7 million, primarily due to increases in personnel costs for employees retained following the Ironshore Acquisition; ● an increase in sales and marketing expenses of $9.5 million, primarily due to expenses incurred to support the ongoing commercialization of Jornay following the Ironshore Acquisition in September 2024; and ● an increase in regulatory fees of $1.8 million, primarily due to fees incurred for Jornay following the Ironshore Acquisition in September 2024. ​ The following is a summary of 2024 quarterly adjusted operating expenses: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ First Quarter ​ Second Quarter ​ Third Quarter ​ Fourth Quarter ​ (in thousands) GAAP operating expenses $ 41,982 ​ $ 43,335 ​ $ 61,955 ​ $ 60,177 Adjustments: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Stock-based compensation ​ 7,475 ​ ​ 10,012 ​ ​ 7,317 ​ ​ 7,596 Litigation settlements ​ — ​ ​ — ​ ​ — ​ ​ — CEO transition expense ​ — ​ ​ 3,051 ​ ​ — ​ ​ — Acquisition related expenses ​ — ​ ​ — ​ ​ 19,886 ​ ​ 4,443 Gain on fair value remeasurement of contingent consideration ​ — ​ ​ — ​ ​ — ​ ​ (2,914) Total adjustments ​ 7,475 ​ ​ 13,063 ​ ​ 27,203 ​ ​ 9,125 Adjusted operating expenses $ 34,507 ​ $ 30,272 ​ $ 34,752 ​ $ 51,052 ​ Adjusted Net Income and Adjusted Earnings Per Share ​ Adjusted net income is a non-GAAP financial measure that represents GAAP net income or loss adjusted to exclude significant income and expense items that are non-cash or not indicative of ongoing operations, including consideration of the tax effect of the adjustments.
The following is a summary of 2025 quarterly adjusted operating expenses: First Quarter Second Quarter Third Quarter Fourth Quarter (in thousands) GAAP operating expenses $ 75,637 $ 73,279 $ 67,084 $ 67,621 Adjustments: Stock-based compensation 11,524 10,818 9,811 9,753 Executive transition expense 1,397 — — — Acquisition related expenses 1,289 935 1,552 399 Gain on fair value remeasurement of contingent consideration (786) (358) (19) (19) Total adjustments $ 13,424 $ 11,395 $ 11,344 $ 10,133 Adjusted operating expenses $ 62,213 $ 61,884 $ 55,740 $ 57,488 56 Table of Contents Adjusted Net Income and Adjusted Earnings Per Share Adjusted net income is a non-GAAP financial measure that represents GAAP net income or loss adjusted to exclude significant income and expense items that are non-cash or not indicative of ongoing operations, including consideration of the tax effect of the adjustments.
We are primarily dependent on the commercial success of Jornay, Belbuca, Xtampza, and the Nucynta Products. ​ In July 2024, we amended and replaced our 2022 Term Loan with the 2024 Term Loan, which consisted of a $320.8 million initial term loan and a $325.0 million delayed draw term loan.
We are primarily dependent on the commercial success of Jornay PM, Belbuca, Xtampza ER, and the Nucynta Products.
Adjusted earnings per share is a non-GAAP financial measure that represents adjusted net income per share.
Adjusted earnings per share is a non-GAAP financial measure that represents adjusted net income per share. Adjusted weighted-average shares - diluted is calculated in accordance with the treasury stock, if-converted, or contingently issuable accounting methods, depending on the nature of the security.
The $9.3 million decrease was primarily due to lower interest expense associated with the 2022 Term as a result of a lower average overall principal balance during 2024, as well as a lower interest rate on the 2024 Term Loan. ​ Interest income was $14.0 million for 2024, compared to $15.6 million for 2023.
Interest expense from term loans was materially consistent in 2025 compared to 2024 due to the refinancing of our term loans in the third quarter of 2024 and the fourth quarter of 2025, which resulted in a lower interest rate offset by a higher principal balance. Interest income was $11.3 million for 2025, compared to $14.0 million for 2024.
Interest Expense ​ Interest expense consists primarily of cash and non-cash interest costs related to our debt, including the term loan issued in March 2022 in connection with the BDSI Acquisition and refinancing our 2020 Term Loan (the “2022 Term Loan”), the term loan issued in July 2024 in connection with the Ironshore Acquisition (the “2024 Term Loan”), convertible notes issued in February 2020 in connection with the Nucynta Acquisition (the “2026 Convertible Notes”), and convertible notes issued in February 2023 (the “2029 Convertible Notes”). ​ Interest Income ​ Interest income consists of interest and amortization of premiums and discounts on investments earned on our cash, cash equivalents, and marketable securities. ​ Provision for Income Taxes ​ The provision for income taxes reflects expense or tax benefit for federal and state income taxes, as well as the impact of non-deductible expenses. 47 ​ ​ Critical Accounting Policies and Estimates Our “Management’s Discussion and Analysis of Financial Condition and Results of Operations” are based on our consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States of America (“GAAP”).
Critical Accounting Policies and Estimates Our “Management’s Discussion and Analysis of Financial Condition and Results of Operations” are based on our consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States of America (“GAAP”).
The $1.8 million increase is primarily due to higher earnings before taxes in 2024, partially offset by 2023 including higher non-deductible costs associated with debt extinguishments.
The $0.3 million increase was primarily due to higher nondeductible items in 2025 compared to 2024, including the impact of nondeductible officer compensation, stock compensation, and provision-to-return adjustments, partially offset by lower earnings before taxes.
The $6.0 million decrease was primarily related to 2023 including higher cost of product revenues related to the step-up basis in inventory acquired from BDSI, partially offset by cost of product revenues for Jornay as well as higher sales volume in 2024 for Belbuca. ​ Intangible asset amortization was $165.3 million for 2024, compared to $145.8 million for 2023.
In addition, revenue increased due to higher gross price partially offset by lower sales volume. 50 Table of Contents Cost of product revenues Cost of product revenues (excluding intangible asset amortization) was $95.4 million for 2025, compared to $88.8 million for 2024.
The $19.5 million increase in intangible asset amortization was primarily related to the Ironshore Acquisition in 2024.
The $56.6 million increase in intangible asset amortization was primarily related to 2025 including a full year of amortization from the intangible asset acquired in the Ironshore Acquisition in September 2024. Operating expenses Selling, general and administrative expenses were $284.8 million for 2025, compared to $210.4 million for 2024.
Removed
This grant extended the period of U.S. exclusivity for Nucynta IR from June 27, 2025 to July 3, 2026. ​ Symproic 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.
Added
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.
Removed
Refer to Note 5, License Agreements , and Note 11, Goodwill and Intangible Assets, for further detail around the intangible assets acquired from the Ironshore Acquisition, the BDSI Acquisition, the Nucynta Intangible Asset, and royalty expenses.
Added
(“Hikma”), pursuant to which we granted Hikma rights relating to an authorized generic version of the Nucynta Products in the United States.
Removed
Our return policy requires that product is returned and that the return is claimed within the 18-month window. Refer to Note 3, Revenue from Contracts with Customers , for more information. Provisions for trade allowances and chargebacks are primarily based on customer-level contractual terms.
Added
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.
Removed
Business Combination Accounting and Valuation of Acquired Assets We completed the Ironshore Acquisition in September 2024 and the BDSI Acquisition in March 2022, both of which were accounted for as business combinations.
Added
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.
Removed
Intangible assets are then amortized over their estimated useful lives using either the straight-line method, or if reliably determinable, based on the pattern in which the economic benefit of the asset is expected to be utilized, which is generally based on our cash flow projections.
Added
Our term loans consist of the term loan issued in December 2025 (the “2025 Term Loan”), which was issued along with a delayed draw term loan and revolving credit facility (collectively, the “2025 Credit Facility”), as well as the term loan issued in July 2024 in connection with the Ironshore Acquisition (the “2024 Term Loan”) and the term loan issued in March 2022 in connection with the BDSI Acquisition (the “2022 Term Loan”).

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

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Biggest changeDue to the nature of our investments, we do not believe that the fair value of our investments has a material exposure to interest rate risk. 59 ​ ​ 2024 Term Loan ​ The 2024 Term Loan bears interest at a rate equal to bear an annual interest rate equal to Secured Overnight Financing Rate (“SOFR”) plus a spread adjustment of 0.13% plus + 4.50%, and is subject to quarterly amortization payments equal to 2.50% of the original funded amount of the 2024 Term Loan.
Biggest changeDue to the nature of our investments, we do not believe that the fair value of our investments has a material exposure to interest rate risk. 2025 Term Loan The 2025 Term Loan bears interest at an annual rate equal to Secured Overnight Financing Rate (“SOFR”) plus a spread adjustment ranging from 2.75% to 3.75%.
Item 7A. Quantitative and Qualitative Disclosures about Market Risks ​ Our primary exposure to market risk is interest rate sensitivity in connection with our investment portfolio and the 2024 Term Loan. None of these market risk sensitive instruments are held for trading purposes. ​ Investment Portfolio ​ Our investment portfolio includes financial instruments that are sensitive to interest rate risks.
Item 7A. Quantitative and Qualitative Disclosures about Market Risks Our primary exposure to market risk is interest rate sensitivity in connection with our investment portfolio and the 2025 Term Loan. None of these market risk sensitive instruments are held for trading purposes. Investment Portfolio Our investment portfolio includes financial instruments that are sensitive to interest rate risks.
We invest in instruments that meet the credit quality, diversification, liquidity, and maturity standards outlined in our investment policy. ​ As of December 31, 2024, our investment portfolio includes $38.1 million of cash equivalents and $92.2 million of marketable securities, which are primarily comprised of money market funds, commercial paper, corporate debt securities, and government-sponsored debt securities.
We invest in instruments that meet the credit quality, diversification, liquidity, and maturity standards outlined in our investment policy. 58 Table of Contents As of December 31, 2025, our investment portfolio includes $119.4 million of cash equivalents and $155.4 million of marketable securities, which are primarily comprised of money market funds, commercial paper, corporate debt securities, and government-sponsored debt securities.
Based on the outstanding principal amount of the 2024 Term Loan as of December 31, 2024 of $629.7 million, a hypothetical 1% increase or decrease in interest rates would increase or decrease future annual interest expense by approximately $6.3 million. ​
Based on the outstanding principal amount of the 2025 Term Loan as of December 31, 2025 of $580.0 million, a hypothetical 1% increase or decrease in interest rates would increase or decrease future annual interest expense by approximately $5.8 million. Item 8.
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The 2025 Term Loan is subject to quarterly amortization payments of the originally funded amount equal to 1.25% in each quarter of 2026, 1.875% in each quarter of 2027 and 2028, and 2.5% in each quarter of 2029 and 2030, with the remaining principal payable at maturity.
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Consolidated Financial Statements and Supplementary Data Our Consolidated Financial Statements, together with the reports of our independent registered public accounting firms, begin on page F - 1 of this Form 10 - K. Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure None.

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