What changed in this filing

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Item 1. Business

2025-02-27 compared with 2024-02-22 · 164 added, 144 removed, 440 unchanged (41% of the section changed)

Our mission is to build a leading, diversified specialty pharmaceutical company committed to improving the lives of people living with serious medical conditions.

We have leveraged our research and development efforts as well as acquisitions and licensing relationships with third parties, to develop a portfolio of meaningfully differentiated products for use in the treatment of moderate to severe pain.

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

Our company was formed in 2002 to help address the opioid epidemic through the development of Xtampza ER, a pain treatment option designed with abuse deterrent properties.

Xtampza ER is an abuse-deterrent, extended-release, oral formulation of oxycodone.

Xtampza ER is formulated using our novel abuse-deterrent technology platform, DETERx, which provides extended-release delivery, while also providing barriers to common methods of abuse and misuse (e.g., crushing, chewing, heating, and injecting).

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.

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

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

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

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.

The acquisition of Ironshore expands our business beyond pain management and establishes a commercial presence in neuropsychiatry via the ADHD market.

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.

Xtampza ER is an abuse-deterrent, extended-release, oral formulation of oxycodone, a Schedule II opioid.

Xtampza ER is formulated using our novel abuse-deterrent technology platform, DETERx, which provides extended-release delivery, which is designed to deter abuse and misuse (e.g., crushing, chewing, heating, and injecting).

This technology combines an active opioid ingredient with a fatty acid and waxes to form microspheres that are filled into a capsule.

These wax-based microspheres are designed to resist particle size reduction and dose dumping when subjected to physical and chemical manipulation.

In April 2016, the United States Food and Drug Administration (“FDA”) approved our New Drug Application (“NDA”) for Xtampza ER.

Xtampza ER is indicated 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.

The approved labeling for Xtampza ER includes human abuse potential studies, as well as data supporting the administration of the product as a sprinkle or through feeding tubes.

Xtampza ER’s label indicates a dosing regimen of one capsule every 12 hours, and it must be taken with food.

In June 2016, we commercially launched Xtampza ER in the United States.

Xtampza ER, OxyContin, and the authorized generic versions of OxyContin (which are identical to the branded versions) are the only extended-release oxycodone products marketed in the United States as of January 2024.

Xtampza ER and OxyContin (along with its authorized generics) feature the same active pharmaceutical ingredient (oxycodone) and feature abuse-deterrent technologies – though the abuse deterrent technologies are designed differently.

In November 2017, we announced FDA approval of a Supplemental New Drug Application (“sNDA”) for Xtampza ER to include comparative oral pharmacokinetic data from a clinical study evaluating the effect of physical manipulation by crushing Xtampza ER compared with OxyContin and a control (oxycodone hydrochloride immediate-release).

In the study, Xtampza ER maintained its extended-release pharmacokinetic profile when crushed, while OxyContin showed a rapid release of oxycodone when crushed with common household tools;

crushed OxyContin was bioequivalent to crushed oxycodone IR.

The sNDA also added results from an oral human abuse potential study and an oral abuse deterrent claim to the label, making Xtampza ER the only single-agent extended-release oxycodone with oral, intranasal, and intravenous abuse-deterrent labeling.

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 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 for three years after introduction into the U.S.

Methods to defeat the tamper resistant properties of Xtampza ER are reported but there is no indication of widespread or expanding abuse or misuse in the data streams evaluated.

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.

Methods to defeat the tamper resistant properties of Xtampza ER have been reported.

However, there is no indication of widespread or expanding abuse or misuse in the data streams evaluated.

Potential limitations are based upon the fact that the Poison Center and Treatment Center Program cases involve self-reporting which may lead to:

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Nucynta Products

The Nucynta Products are extended-release (“ER”) and immediate-release (“IR”) oral 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.

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exclusivity for Nucynta IR from June 27, 2025 to July 3, 2026.

We began commercializing the Nucynta Products in 2018 pursuant to a commercialization agreement (the “Nucynta Commercialization Agreement”) with Assertio Therapeutics, Inc.

(formerly known as Depomed) (“Assertio”), pursuant to which Assertio granted us a sublicense of certain of its intellectual property related to the Nucynta Products for commercialization of such products in the United States.

In February 2020, we acquired additional assets related to the Nucynta Products from Assertio and assumed all commercialization responsibilities, including sales and marketing, for the Nucynta Products through the acquisition of a license from Grünenthal Gmbh (the “Grünenthal License” and such acquisition, the “Nucynta Acquisition”).

Upon closing the Nucynta Acquisition, the Nucynta Commercialization Agreement and our prior royalty obligation to Assertio ceased;

our only remaining royalty obligation is to pay royalties directly to Grünenthal Gmbh based on net sales of the Nucynta Products under the Grünenthal License.

Belbuca and Symproic

On March 22, 2022, we acquired BioDelivery Sciences International, Inc.

(“BDSI”), a specialty pharmaceutical company working to deliver innovative therapies for individuals living with serious and debilitating chronic conditions (the “BDSI Acquisition”).

Upon closing the BDSI Acquisition, we acquired Belbuca and Symproic.

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.

We began shipping and recognizing product sales related to Belbuca and Symproic in March 2022.

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.

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.

Attention Deficit Hyperactivity Disorder (ADHD) & Treatment

ADHD is a CNS disorder characterized by developmentally inappropriate levels of inattention, hyperactivity, and impulsivity.

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

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

ADHD often begins in childhood and can persist into adulthood.

The prevalence of children ever diagnosed increases by age.

Over 90% of individuals with childhood ADHD will continue to struggle with residual, fluctuating symptoms and impairments through young adulthood.

ADHD symptoms may present as predominantly inattentive, predominantly hyperactive/impulsive, or combined inattentive/hyperactive/impulsive.

ADHD may contribute to low self-esteem, troubled relationships, and difficulty at school or work.

Treatment for ADHD

Patients with ADHD seek treatment primarily due to functional impairment while physicians have historically focused on achieving symptom control.

The current era of ADHD management is marked by a rich and diverse treatment options that expands from cognitive behavioral therapy, training interventions, to pharmacotherapy or a combination approach.

Stimulants and nonstimulants are approved for the treatment of ADHD;

however, stimulants are considered first-line therapy in children, adolescents, and adults with ADHD because of their greater efficacy.

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

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acute pain, or pain that is self-limited and generally requires treatment for no more than up to a few weeks, and chronic pain, or pain that lasts beyond the healing of an injury or that persists longer than 3 to 6 months.

The overall prevalence of chronic pain among adults in the United States is 20.9%, affecting approximately 51.6 million Americans.

The overall prevalence of chronic pain among adults in the United States is 24.3%.

Additionally, 8.5% of the U.S.

adult population, approximately 17.1 million people, suffer from high-impact chronic pain that frequently limits life or work activities.

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

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

between $560.0 and $635.0 billion per year in direct medical costs and lost productivity, which does not include the cost of care for institutionalized

individuals (e.g., nursing home residents, prisoners), military personnel, or children, or the costs associated with caregiving.

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

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

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

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

The beginning of the opioid overdose epidemic in

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

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

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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 2021, the number of reported deaths involving prescription opioids totaled 16,706, worsening from 2019 levels.

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”).

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The FDA has encouraged the development of prescription opioids with abuse-deterrent formulations to help combat the opioid crisis, and expanding access to abuse deterrent formulations is part of the FDA’s comprehensive Opioids Action Plan.

These technologies, however, do not eliminate the possibility of

misuse and abuse.

Moreover, no abuse deterrence technology, including DETERx, is able to deter the most common form of abuse—swallowing a number of intact capsules or tablets to achieve a feeling of euphoria.

These technologies, however, do not eliminate the possibility of misuse and abuse.

Moreover, no abuse deterrence technology, including DETERx, is able to deter the most common form of abuse, i.e., swallowing a number of intact capsules or tablets to achieve a feeling of euphoria.

Legislative and Regulatory Actions

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Manufacturing of Our Products

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

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

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

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

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.

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

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

Xtampza ER is manufactured using a proprietary process.

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The Nucynta Products are manufactured pursuant to supply agreements with third-party manufacturers.

Nucynta ER was historically produced by Janssen at a facility in Puerto Rico pursuant to a supply agreement that we assumed from Assertio in connection with the Nucynta Acquisition.

In September 2022, we completed the transfer of the Nucynta ER manufacturing process through a technology transfer program to enable manufacturing of Nucynta ER at Patheon in Cincinnati, Ohio.

Nucynta ER is currently manufactured by Patheon.

Nucynta ER is currently manufactured by Patheon in Cincinnati, Ohio.

Nucynta IR is manufactured by Halo Pharmaceutical, Inc.

in Whippany, New Jersey.

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

Belbuca laminate (i.e., bulk product) is produced by Adhesives Research in Glen Rock, Pennsylvania.

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

Paul, Minnesota or Sharp Packaging Solutions in

Allentown, Pennsylvania where it is converted into individual dosage units and, ultimately, into finished goods.

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

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

Symproic is manufactured by UPM Pharmaceuticals in Bristol, Tennessee and packaged by Sharp Packaging Solutions in Allentown, Pennsylvania.

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DEA Drug Schedule

Methylphenidate

Buprenorphine

Not a controlled substance

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

Xtampza ER 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.

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

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

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

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Marketing and Commercialization

We commercialize our products in the United States with a dedicated field sales force, consisting of approximately 110 sales representatives and managers, to call on the approximately 10,000 health care professionals who write approximately 66% of the branded extended-release opioid prescriptions in the United States, with a primary focus on pain specialists.

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

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.

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

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

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

Our marketing strategy focuses on increasing awareness of the differentiated features of our products.

As an integral part of educating clinicians regarding the properties and differentiated profiles of our products, our sales force is trained to share information relating to significant risks associated with prescription opioids, including risks relating to addiction, abuse, and misuse.

As an integral part of educating clinicians regarding the properties and differentiated profiles of our products, our sales force is trained to share information relating to significant risks associated with prescription opioids and stimulants, as applicable, including risks relating to addiction, abuse, and misuse.

We primarily sell our products to wholesalers that, in turn, distribute our products to retail outlets (such as drug store and supermarket chains and independent pharmacies), managed health care organizations and government agencies.

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

Nucynta IR is also covered by New Patient Population exclusivity in

pediatric patients that is projected to expire in 2026.

Nucynta ER is protected by four 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 2024, 2025, and 2028.

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.

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

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

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

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

Except for licenses from Grünenthal GmbH to commercialize the Nucynta Products in the United States and its territories, and a license from Shionogi to commercialize Symproic in the United States and its territories, our technology and products are not in-licensed from any third party, and we own all of the rights to Xtampza ER.

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

We also rely on trademarks and trade designs to develop and maintain our competitive position.

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 the Nucynta Acquisition and Belbuca and Symproic in connection with the BDSI Acquisition.

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”);

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.

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

We face competition and potential competition from several sources, including pharmaceutical and biotechnology companies, generic and branded drug companies, drug delivery companies and academic and research institutions.

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

Our competitors include major multinational pharmaceutical companies, biotechnology

companies and universities and other research institutions.

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

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.

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

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Long-term preclinical tests, such as animal tests of reproductive toxicity and carcinogenicity, may continue after the IND application is submitted.

The IND becomes effective 30 days after receipt by the FDA, unless the FDA raises concerns or questions regarding the proposed clinical trials and places the IND on clinical hold within that 30-day time period.

In such a case, the IND sponsor and the FDA must resolve any outstanding concerns or questions before the clinical trial can begin.

The FDA may also impose clinical holds on a drug candidate at any time before or during clinical trials due to safety concerns or non-compliance.

Clinical trials involve the administration of the investigational new drug to healthy volunteers or subjects under the supervision of a qualified investigator.

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and (ii) under protocols detailing, among other things, the objectives of the trial, the parameters to be used in monitoring safety, and any effectiveness criteria to be evaluated.

Each protocol, and any subsequent amendments to the protocol, must be submitted to the FDA as part of the IND.

Further, each clinical trial must be reviewed and approved by an independent institutional review board, or IRB, at or servicing each institution at which the clinical trial will be conducted.

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

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

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

Failure to timely register a clinical trial or to submit study results to such public registries can give rise to civil monetary penalties and also prevent a non-compliant party from receiving future grant funds from the federal government.

Clinical trials to support NDAs for marketing approval are typically conducted in three sequential phases, but the phases may overlap or be combined.

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These studies typically include several hundred to several thousand patients and are conducted to gather additional information about the effectiveness and safety of the drug in order to evaluate the overall risk-benefit relationship and provide an adequate basis for labeling.

Post-approval trials, sometimes referred to as Phase 4 clinical trials, may be conducted after initial marketing approval.

These trials are used to gain additional experience from the treatment of patients in the intended therapeutic indication.

In certain instances, the FDA may mandate the performance of Phase 4 clinical trials as a condition of approval on an NDA.

Progress reports detailing the results of the clinical trials must be submitted at least annually to the FDA and more frequently if serious adverse events occur.

Written IND safety reports must be submitted to the FDA and investigators for serious and unexpected suspected adverse events, findings from other studies or animal or in vitro testing that suggest a significant risk for human subjects and any clinically important increase in the rate of a serious suspected adverse reaction over that listed in the protocol or investigator brochure.

The sponsor must submit an IND safety report within 15 calendar days after the sponsor determines that the information qualifies for reporting.

The sponsor also must notify the FDA of any unexpected fatal or life-threatening suspected adverse reaction within seven calendar days after the sponsor’s initial receipt of the information.

Furthermore, the FDA or the sponsor may suspend or terminate a clinical trial at any time on various grounds, including a finding that the research subjects are being exposed to an unacceptable health risk.

Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution if the clinical trial is not being conducted in accordance with the IRB’s requirements or if the drug has been associated with unexpected serious harm to patients.

Additionally, some clinical trials are overseen by an independent group of qualified experts organized by the clinical trial sponsor, known as a data safety monitoring board or committee.

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.

The manufacturing process must be capable of consistently producing quality batches of product and, among other things, companies must develop methods for testing the identity, strength, quality and purity of the final product.

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.

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The FDA conducts a preliminary review of all NDAs within the first 60 days after submission before accepting them for filing.

Pursuant to agreements reached during reauthorization of the Prescription Drug User Fee Act (“PDUFA”), the FDA has a goal of acting on most original NDAs within six months or ten months of the application submission or filing date, depending on the nature of the drug and application type.

Pursuant to agreements reached during reauthorization of the Prescription Drug User Fee Act (“PDUFA”), the FDA has a goal of acting on most original NDAs within six months or ten months of the application filing date, depending on the nature of the drug and whether the application is assigned a priority or standard review.

The FDA has a number of programs intended to help expedite testing, review, and approval of drug candidates that meet certain eligibility criteria.

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These ETASU include REMS-compliant accredited continuing education for healthcare providers, which includes all healthcare providers who prescribe or are involved in the management of patients with pain;

information provided to prescribers that they can use

to educate patients in the safe use, storage, and disposal of opioids;

information provided to prescribers that they can use to educate patients in the safe use, storage, and disposal of opioids;

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

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In connection with the 2018 REMS, the FDA also approved new product labeling containing information about the health care provider education available through the 2018 REMS.

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

Advertising and Promotion

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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 registration, recordkeeping, periodic reporting, product sampling and distribution, adverse event reporting and advertising, marketing and promotion restrictions.

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.

In addition, the Drug Supply Chain Security Act (“DSCSA”), was enacted in 2013 with the aim of building an electronic system to identify and trace certain prescription drugs and biologics distributed in the United States.

The DSCSA mandates phased-in and resource-intensive obligations for pharmaceutical manufacturers, wholesale distributors, and dispensers that culminated in November 2023.

The FDA has issued two compliance policy guidances that establish a one-year stabilization period from November 2023 to November 2024 for trading partners to continue to build and validate interoperable systems and processes to meet certain requirements of the DSCSA.

The FDA established a one-year stabilization period until November 2024 for trading partners to continue to build and validate interoperable systems and processes to meet certain requirements of the DSCSA.

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

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

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

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

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

hyperalgesia.

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

We participated in this meeting and as a result, the proposed design of study 3033-11, the enriched enrollment randomized withdrawal design was not supported.

As part of the Opioid PMR Consortium, Collegium is working with the FDA to redesign study 3033-11.

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.

In addition to new legislation, FDA regulations, guidances, and policies are often revised or reinterpreted by the agency in ways that may significantly affect the manner in which pharmaceutical products are regulated and marketed

The Hatch-Waxman Amendments

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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.

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.

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.

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

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

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

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

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In addition, a DEA quota system controls and limits the availability and production of controlled substances in Schedule I or II.

Annually, the DEA establishes an aggregate quota for how much active opioid ingredients, such as oxycodone and tapentadol, may be produced in total in the United States based on the DEA’s estimate of the quantity needed to meet legitimate scientific and medicinal needs.

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

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

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

Annually, the DEA establishes an aggregate quota for how much active opioid ingredients, such as oxycodone, tapentadol, and methylphenidate, may be produced in total in the United States based on the DEA’s estimate of the quantity needed to meet legitimate scientific and medicinal needs.

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

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

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

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

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

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

Remuneration is not defined in the federal Anti-Kickback Statute and has been broadly interpreted to include anything of value, including for example, gifts, discounts,

coupons, the furnishing of supplies or equipment, credit arrangements, payments of cash, waivers of payments, ownership interests and providing anything at less than its fair market value.

Under the federal Anti-Kickback Statute and the applicable criminal healthcare fraud statutes contained within 42 U.S.C.

§ 1320a-7b, a person or entity need not have actual knowledge of this statute or specific intent to violate it in order to have committed a violation.

In addition, the government may assert that a claim including items or services resulting from a violation of 42 U.S.C.

§ 1320a-7b, constitutes a false or fraudulent claim for purposes of the civil False Claims Act (discussed below) or the civil monetary penalties statute, which imposes fines against any person who is determined to have presented or caused to be presented claims to a federal healthcare program that the person knows or should know is for an item or service that was not provided as claimed or is false or fraudulent.

The federal Anti-Kickback Statute and implementing regulations provide for certain exceptions for “safe harbors” for certain discounting, rebating or personal services arrangements, among other things.

However, the lack of uniform court interpretation of the Anti-Kickback Statute makes compliance with the law difficult.

Violations of the federal Anti-Kickback Statute 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.

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

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

In addition, the government may assert that a claim including items or services resulting from a violation of the AKS, constitutes a false or fraudulent claim for purposes of the civil False Claims Act (discussed below) or the civil monetary penalties statute, which imposes fines against any person who is determined to have presented or caused to be presented claims to a federal healthcare program that the person knows or should know is for an item or service that was not provided as claimed or is false or fraudulent.

The AKS and implementing regulations provide exceptions under certain “safe harbors” for discounting, rebating or personal services arrangements, among other things.

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

Violations of the AKS can

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

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

The Criminal Healthcare Fraud statute, 18 U.S.C.

§ 1347 prohibits knowingly and willfully executing a scheme to defraud any healthcare benefit program, including private third-party payors.

§ 1347, for example, prohibits knowingly and willfully executing a scheme to defraud any healthcare benefit program, including private third-party payors.

Federal criminal law at 18 U.S.C.

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

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

practitioners, and to teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members.

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

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

state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government that otherwise restricts payments that may be made to healthcare providers and other potential referral sources;

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

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

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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, 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.

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

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

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

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

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

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

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Any reduction in payment that results from Medicare Part D may result in a similar reduction in payments from non-governmental payors.

In March 2010, the Affordable Care Act was enacted, which significantly changed the way healthcare is financed by both governmental and private insurers.

Among the provisions of the Affordable Care Act of importance to the pharmaceutical and biotechnology industry are the following:

In March 2010, the ACA was enacted, which significantly changed the way healthcare is financed by both governmental and private insurers.

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;

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● 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 Affordable Care Act has been subject to challenges in the courts.

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.

As a result, the Supreme Court did not rule on the constitutionality of the Affordable Care Act or any of its provisions.

As a result, the Supreme Court did not rule on the constitutionality of the ACA or any of its provisions.

In addition, other legislative changes have been proposed and adopted since the Affordable Care Act was enacted.

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These laws may result in additional reductions in Medicare and other healthcare funding, which could have a material adverse effect on our customers and, accordingly, our financial operations.

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

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

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

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

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

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CMS, payors, manufacturers, and beneficiaries.

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

Starting in 2025, all remaining components of the Part D Redesign will take effect.

Ultimately, the existing coverage gap will be removed and replaced with greater exposure for manufacturers after the beneficiary pays their deductible.

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

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

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

Some manufacturers, including Collegium, will qualify for a “phase in” of rebate utilization for the LIS population which should limit our exposure in the short term, but will increase it over time.

Some manufacturers, including Collegium, may be able to qualify for a “phase in” of rebate utilization for the LIS population which should limit our exposure in the short term, but will increase it over time.

The implementation of the IRA is currently subject to ongoing litigation that challenges the constitutionality of the IRA’s Medicare drug price negotiation program.

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

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

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

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

In February 2024, we published our annual ESG report on our corporate website highlighting our ESG accomplishments to date.

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

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

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employee training and development;

diversity and inclusion;

nurturing a positive culture;

and employee health and safety.

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

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

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

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

Employee Training and Development

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Our comprehensive performance review process ensures our employees are on track with their development throughout the year.

Diversity, Equity, and Inclusion

We are committed to fostering diversity, equity, and inclusion (“DEI”) in our workplace.

We are unwavering in our commitment to treat our colleagues fairly, and we are open-minded and inclusive in our engagements with one other, our partners, and customers.

We believe that when people feel appreciated and included, they are more creative, innovative, and successful, which in turn improves our business and performance and enhances shareholder value.

We are committed to employing people whose diverse backgrounds contribute to innovation and allow us to approach the complex issues that face our industry from many different perspectives.

We are executing our multi-year DEI strategic plan that strives to integrate DEI with our overall business goals by focusing on topics such as developing, retaining, and attracting talent;

creating and sustaining a work environment where all employees feel valued and engaged;

and developing a strong reputation and strategic alliance partnerships with the communities we serve.

As of December 2023, we had a total of 197 employees with representation with respect to gender and self-reported race and ethnicity as follows:

Asian (Not Hispanic or Latino)

Black or African American (Not Hispanic or Latino)

Hispanic or Latino

Prefer Not to Disclose

Two or More Races (Not Hispanic or Latino)

White (Not Hispanic or Latino)

As in everything we do, we are committed to continuous improvement in this area.

While we are proud of the diversity of backgrounds and identities that our workforce exhibits, we will make the necessary investments of time, resources, and engagement to make sustained improvements in this area.

Employee Health and Safety

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We provide all employees and their families with access to a variety of innovative, flexible, and convenient health and wellness programs.

As of December 31, 2024, we had a total of 357 full-time employees.

Our Executive Officers

The following table lists the positions, names and ages of our executive officers as of February 27, 2025:

Joseph Ciaffoni

Vikram Karnani

Director, President and Chief Executive Officer

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Shirley Kuhlmann

Executive Vice President, General Counsel and Chief Administrative Officer

Executive Vice President, Chief Administrative Officer and General Counsel

Executive Vice President and Chief Medical Officer

Joseph Ciaffoni, Director, President and Chief Executive Officer.

Ciaffoni was appointed as our President and Chief Executive Officer of Collegium Pharmaceutical in July 2018.

Ciaffoni joined us in May 2017 as Executive Vice President and Chief Operating Officer.

Prior to joining us, he served as President, U.S.

Branded Pharmaceuticals of Endo International plc.

Before that, Mr.

Ciaffoni held various positions of increasing responsibility at Biogen, including Senior Vice President, Global Specialty Medicines Group, Senior Vice President, U.S.

Commercial and Vice President, U.S.

Neurology Field Operations and Marketing.

Prior to joining Biogen, he was Executive Vice President and Chief Operating Officer of Shionogi Inc.

and President of Shionogi Pharmaceuticals.

Ciaffoni also previously served as Vice President, Sales for Schering-Plough (now Merck) and held several commercial leadership roles at Sanofi-Synthelabo (now Sanofi) and Novartis.

Ciaffoni received a B.A.

in Communications and an M.B.A.

from Rutgers.

Vikram Karnani, Director, President and Chief Executive Officer.

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

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

(“Amgen”), a global biotechnology company.

Karnani joined Amgen in October 2023 through Amgen’s acquisition of Horizon Therapeutics plc (“Horizon”).

Karnani joined Horizon in 2014, holding numerous leadership positions including Executive Vice President and President, International, from August 2020 until October 2023;

Executive Vice President and Chief Commercial Officer from March 2018 to August 2020;

Senior Vice President, Rheumatology Business Unit from February 2017 to March 2018;

and General Manager, Specialty Business Unit from July 2014 until February 2017.

Prior to joining Horizon, Mr.

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

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

Colleen Tupper, Executive Vice President and Chief Financial Officer.

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

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

He has over 25 years of commercial experience

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

Most recently, Mr.

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in Biology from Messiah College.

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

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

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

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

Smith has more than twenty-five 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.

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.

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

What changed 10-K

Item 1. Business