What changed in this filing

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Item 1. Business

2021-02-25 compared with 2020-02-27 · 175 added, 162 removed, 383 unchanged (47% of the section changed)

We are a specialty pharmaceutical company committed to being the leader in responsible pain management.

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

In April 2016, the U.S.

Food and Drug Administration (“FDA”) approved our New Drug Application (“NDA”), for Xtampza ER for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

In June 2016, we announced the commercial launch of Xtampza ER.

Our product portfolio also includes Nucynta ER and Nucynta IR (collectively, the “Nucynta Products”).

In December 2017, we entered into a Commercialization Agreement with Assertio Therapeutics, Inc.

(formerly known as Depomed) (“Assertio”), pursuant to which we licensed the right to commercialize the Nucynta Products in the United States.

Nucynta ER is an extended-release (“ER”) formulation of tapentadol that is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment, including neuropathic pain associated with diabetic peripheral neuropathy in adults, and for which alternate treatment options are inadequate.

Nucynta IR is an immediate-release (“IR”) formulation of tapentadol that is indicated for the management of acute adult pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

We began shipping and recognizing product sales on the Nucynta Products on January 9, 2018 and began marketing the Nucynta Products in February 2018.

On February 13, 2020, we closed our acquisition of certain assets related to the Nucynta Products, including the right to commercialize the Nucynta Products in the United States and certain regulatory and supply chain assets (the “Nucynta Acquisition”), from Assertio for an aggregate purchase price of $375.0 million, subject to certain adjustments as set forth in that certain Asset Purchase Agreement, dated as of February 6, 2020, by and between us and Assertio (the “Nucynta Purchase Agreement”) .

Our portfolio includes Xtampza ER, an abuse-deterrent, extended-release, oral formulation of oxycodone and Nucynta ER and Nucynta IR (collectively, the “Nucynta Products”), which are extended-release (“ER”) and immediate-release (“IR”) formulations of tapentadol.

Xtampza ER was approved by the U.S.

Food and Drug Administration (“FDA”) in April 2016 for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

We commercially launched Xtampza ER in June 2016.

Nucynta ER is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment, including neuropathic pain associated with diabetic peripheral neuropathy in adults, and for which alternate treatment options are inadequate.

Nucynta IR is indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults.

We initially licensed the right to commercialize the Nucynta Products in the United States through a Commercialization Agreement with Assertio Therapeutics, Inc.

(formerly known as Depomed) (“Assertio”) entered into in December 2017 (the “Nucynta Commercialization Agreement”) and began marketing the Nucynta Products in February 2018.

On February 13, 2020, we closed our acquisition of certain assets related to the Nucynta Products, including the right to commercialize the Nucynta Products in the United States and certain regulatory and supply chain assets (the “Nucynta Acquisition”), from Assertio for an aggregate purchase price of $375.0 million, subject to certain adjustments as set forth in the Asset Purchase Agreement, dated as of February 6, 2020, between us and Assertio (the “Nucynta Purchase Agreement”) .

For the fiscal year ended December 31, 2020, we generated $310.0 million in net revenues, comprised of $128.0 million from sales of Xtampza ER and $182.0 million from sales of the Nucynta Products.

We are headquartered in Stoughton, Massachusetts and our common stock trades on the NASDAQ Global Select Market (“NASDAQ”) under the trading symbol “COLL.”

The COVID-19 pandemic has severely impacted global economic activity, and federal and state governments, as well as numerous foreign countries, have reacted to the outbreak by instituting quarantines, mandating business and school closures and restricting travel.

The travel restrictions and “social distancing” recommendations resulting from the spread of COVID-19, as well as the closure or limited operations of many physicians’ offices, have impacted our sales professionals’ ability to travel to and meet with healthcare providers in person.

As of the date of the filing of this Annual Report on Form 10-K, the COVID-19 pandemic and actions taken to contain it have impacted revenue (due to fewer new patients beginning therapy with our products and the pandemic’s adverse impact on our ability to promote products) and decreased certain operating expenses, including travel, marketing and expenses associated with participation in congresses that have been postponed.

We believe that the disruptions caused by COVID-19 will continue in the near term, and there remains substantial uncertainty as to when such disruptions will cease (or ease).

Pain, Pain Management and Opioid Abuse in the United States

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According to a 2019 U.S.

Centers for Disease Control and Prevention (“CDC”) report, chronic pain affects between 50-100 million U.S.

adults annually, with as many as 19.6 million of those adults experiencing high impact chronic pain, defined as pain that interferes with daily life or work activities.

Centers for Disease Control and Prevention (“CDC”) report, it is estimated that chronic pain affects at least 40 million U.S.

adults annually, with at least 14 million of those adults experiencing high impact chronic pain, defined as chronic pain that interferes with daily life or work activities most days or every day.

Acute pain is even more prevalent and can occur after an injury, burn, trauma or surgery.

Chronic pain leads to over $560 billion in healthcare and productivity costs each year according to a 2011 report from the Institute of Medicine.

Chronic pain leads to over $560 billion in healthcare and productivity costs annually, according to a 2011 report from the Institute of Medicine.

In addition, studies suggest that healthcare costs for people suffering from chronic pain are higher, and often substantially higher, than for those without chronic pain.

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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.

In 2019, there were approximately 170 million prescriptions for opioids written in the United States, representing a 9% decline from 2018 levels and including approximately 3.7 million prescriptions for branded extended-release opioids, approximately 14.2 million prescriptions for generic extended-release opioids, and greater than 152 million prescriptions for immediate-release opioids.

Increasingly, practitioners and regulators are focusing on multidisciplinary, multimodal approaches to pain management, including exercise, physical and psychotherapy, and opioid and non-opioid medications.

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 practices that may help mitigate the risk of addiction and other adverse events to patients.

Prescription Opioid Abuse is an Epidemic in the United States

In 2020, there were approximately 157.1 million prescriptions for opioids written in the United States, representing an 8% decline from 2019 levels and including approximately 3.2 million prescriptions for branded extended-release opioids, approximately 13.1 million prescriptions for generic extended-release opioids, and greater than 140.8 million prescriptions for immediate-release opioids.

After marked increases in opioid prescriptions from 2000 to 2015, prescriptions have decreased each year since 2015, correlated with rising awareness of the extent and impact of the opioid crisis.

Prescription levels for 2020 represent a return to levels similar to these seen in the year 2000, when 143.8 million prescriptions for opioid were written in the United States, including 11.4 million prescriptions for extended-release opioids and 132.3 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.

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 practices that may help mitigate the risks of abuse, addiction and other adverse events to patients.

Prescription Opioid Abuse in the United States

Prescription opioids of all kinds, including both immediate-release and extended-release formulations, are subject to manipulation, misuse, and abuse.

Abuse-deterrent technologies, including the DETERx platform that is incorporated in Xtampza ER, have emerged to reduce the risk of abuse of prescription opioids, but these technologies do not eliminate the possibility of misuse and abuse.

Extended-release opioids, with their large payload of active pharmaceutical ingredient, may be especially attractive to potential abusers, who tamper with these formulations to overcome the extended-release mechanism and achieve the euphoria that results from rapid increases in the blood concentration of the active pharmaceutical ingredient, a potentially fatal activity known as dose dumping.

The CDC described abuse of prescription drugs in the United States as a vast and deadly epidemic.

According to a 2019 CDC report, there were a record-high 70,237 drug overdose deaths in the United States in 2017, representing a rate of 21.7 per 100,000 persons.

Prescription and/or illicit opioids were involved in 47,600, or 67.8%, of these drug overdose deaths, with over 17,000 of these fatalities attributed to prescription opioids alone.

According to the CDC, the most recent data suggest that opioid-involved overdose deaths declined from 2017 to 2018, in contrast to the sharp increases during 2014 to 2017.

Besides their accepted uses for analgesia, opioids produce a general sense of well-being or euphoria by reducing tension, anxiety, and aggression.

These effects contribute to the attractiveness of opioids for abuse and, indeed, the CDC has described abuse of prescription drugs in the United States as a vast and deadly epidemic.

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

For a variety of reasons, heroin use began increasing in the mid-2000s, and had surpassed prescription opioids as a cause of opioid-related overdose by 2016, reaching a rate of 4.9 per 100,000 persons in 2018.

Meanwhile, the predominant opioid cause of death in 2018 involved synthetic opioids other than methadone.

While opioid-involved 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.

Moreover, and despite the decrease in prescription opioid utilization, the rate of opioid-involved overdose deaths rose slightly again in 2019 (from 20.7 per 100,000 to 21.6), and there are early indications that widespread social isolation, coupled with reduced access to harm reduction services, has been correlated with a substantial upswing in such deaths beginning in early 2020.

The opioid epidemic has, in addition to its death toll, imposed significant burdens on the U.S.

healthcare system.

In 2016, an estimated 91,840 hospitalizations occurred for opioid-related poisonings in the U.S.

In addition, 2016 saw an estimated 197,970 emergency department visits for opioid-related poisonings in the U.S.

A nonprofit group that studies the health economy recently estimated that the opioid epidemic has cost the U.S.

more than a trillion dollars since 2001, based on CDC mortality data through June of 2017.

In 2016, there were an estimated 91,840 hospitalizations and 197,970 emergency department visits for opioid-related poisonings in the United States.

A nonprofit group that studies the health economy recently estimated that the opioid epidemic has cost the United States more than a trillion dollars since 2001, based on CDC mortality data through June 2017.

The greatest financial cost of the epidemic, according to the report, is in lost earnings and productivity losses to employers.

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

Despite the reduction in opioid prescriptions in recent years and the heightened awareness of the risks associated with opioid use, abuse of prescription opioids, including extended-release formulations, continues to be a major public health issue.

In 2019, an estimated 10.1million, or 3.7% of persons aged 12 and older, reported opioid misuse in the prior year.

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 (an effect known as “dose dumping”).

By manipulating these products, therefore, people who abuse opioids achieve a more intense euphoria as a result of rapid increases in the blood concentration of the active pharmaceutical ingredient.

In response to issues surrounding abuse of prescription opioids, pharmaceutical companies have developed novel, abuse-deterrent formulation strategies.

Abuse-deterrent formulations target the known or expected routes of abuse, such as crushing in order to snort or dissolving in order to inject, for the specific opioid drug substance.

Abuse-deterrent formulations, including the DETERx platform that is incorporated in Xtampza ER, target the known or expected routes of abuse, such as crushing in order to snort or dissolving in order to inject, for the specific opioid drug substance.

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.

Legislative and Regulatory Actions

In response to widespread prescription opioid abuse, the U.S.

government and a number of state legislatures have enacted legislation and regulations intended to fight the opioid epidemic.

The number and scope of legislative and regulatory actions, particularly in the last three years, emphasize the severity of the opioid epidemic and its impact on our society.

The FDA has stated that addressing prescription drug abuse is a priority and has reaffirmed that the development of abuse-deterrent opioids is a key part of that strategy.

Recent actions to address the opioid abuse epidemic include:

● FDA guidance :

In April 2015, the FDA adopted final guidance regarding studies and clinical trials that should be conducted to demonstrate that a given formulation has abuse-deterrent properties, 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.

The guidance describes four categories of abuse-deterrence studies and clinical trials:

Categories 1, 2 and 3 consist of pre-marketing studies and clinical trials designed to evaluate a product candidate’s potentially abuse-deterrent properties under controlled conditions, while Category 4, post-marketing clinical trials and studies, assesses the real-world impact of abuse-deterrent formulations.

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.

● FDA Opioids Action Plan:

In February 2016, the FDA released an action plan to address the opioid abuse epidemic and reassess the FDA’s approach to opioid medications.

The FDA’s plan is part of a broader initiative led by the U.S.

Department of Health and Human Services (“HHS”), to address opioid-related overdose, death and dependence.

As part of the HHS initiative:

o CDC Prescribing Guidelines :

In March 2016, the CDC released a new Guideline for Prescribing Opioids for Chronic Pain intended to assist primary care providers treating adults for chronic pain in outpatient settings.

The guideline provides recommendations to improve communications between doctors and patients about the risks and benefits of opioid therapy for chronic pain, improve the safety and effectiveness of pain treatment, and reduce the risks associated with long-term opioid therapy.

o Enhanced Warnings and Safety Labeling :

In March 2016, the FDA announced required enhanced warnings for immediate-release opioid pain medications related to risks of misuse, abuse, addiction, overdose, and death.

Subsequently, there have been several class-wide labeling changes, including the addition of boxed warnings relating to serious risks of using certain opioids medications along with benzodiazepines and other central nervous system depressants, including alcohol (Decembers 2016);

and additional information relating to the new class-wide REMS (Septembers 2018).

● Passage of the Comprehensive Addiction and Recovery Act (CARA and CARA 2.0):

In 2016, the Comprehensive Addiction and Recovery Act (“CARA”), was enacted to address the national epidemics of prescription opioid abuse and heroin use.

Consistent with the initiatives of HHS, this legislation sought to, among other things, expand the availability of naloxone for law enforcement and other first responders;

form an interagency task force to develop best practices for pain management with opioid medications;

and provide resources to improve state monitoring of controlled substances, including opioids.

In 2018, CARA 2.0 was introduced as follow-up legislation to limit initial prescriptions for opioids to 3 days, while exempting initial prescriptions for chronic care, cancer care, hospice or end of life care, and palliative care.

● Passage of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act) :

In November 2018, the SUPPORT Act was enacted as a comprehensive legislative response to the continuing opioid epidemic.

It includes a number of measures directed towards regulation and improvement of treatment for substance use-disorder and increased coverage by CMS of medically-assisted treatment options.

In addition, the SUPPORT Act requires HHS to report to Congress on existing barriers to access to abuse-deterrent opioid formulations by Medicare Part C and D beneficiaries.

government and a number of state legislatures have in recent years enacted new legislation and regulations intended to fight the opioid epidemic.

At the federal level (in addition to the DEA and FDA efforts discussed elsewhere in this Annual Report on Form 10-K), in 2016 the CDC issued prescribing guidelines intended to reduce opioid-related harms by encouraging primary care physicians to limit the amount of morphine milligram equivalents (MMEs) that they prescribe for chronic pain patients.

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.

Recent years have also seen a variety of proposed and enacted laws and regulations at the federal, state and local level intended to reduce, or limit increases in, pharmaceutical prices, including particularly prescription drug price disclosure laws.

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.

The Collegium Portfolio

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

In April 2016, the FDA approved our NDA for Xtampza ER (extended-release oxycodone) for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment 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 administered through feeding tubes.

In April 2016, the FDA approved our New Drug Application (“NDA”) for Xtampza ER (extended-release oxycodone) for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment 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.

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

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).

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.

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.

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

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OxyContin is the largest selling extended-release oxycodone (and largest-selling branded extended-release opioid) in the United States by dollars and prescription volume, with approximately $1.0 billion in U.S.

sales and approximately 2.1 million prescriptions written in 2019.

gross sales and approximately 1.9 million prescriptions written in 2020.

Relative to 2019, dollars generated by sales for OxyContin and its authorized generic forms written in the United States in 2020 declined 17%, with a 20% decline prescription volume.

In 2019, there were approximately 466,000 prescriptions of Xtampza ER written.

In 2020, approximately 566,000 prescriptions for Xtampza ER were written.

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

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Nucynta ER and Nucynta IR

In December 2017, we entered into the Nucynta Commercialization Agreement, pursuant to which Assertio agreed to grant us a sublicense of certain of its intellectual property related to the Nucynta Products for commercialization of such products in the United States.

On January 9, 2018, we amended the Nucynta Commercialization Agreement and consummated the transactions contemplated thereby.

On February 13, 2020, we closed the Nucynta Acquisition.

Upon the closing of the Nucynta Acquisition and the termination of the Nucynta Commercialization Agreement (except for certain sections that survive in accordance with the Nucynta Purchase Agreement), we assumed all commercialization responsibilities, including sales and marketing, for the Nucynta Products.

We began shipping and recognizing product sales on the Nucynta Products on January 9, 2018 and we began commercial promotion of the Nucynta Products in February 2018.

The Nucynta Commercialization Agreement initially required us to pay guaranteed minimum royalty of $135.0 million per year through December 2021, as well as a variable royalty based on annual net sales over $233.0 million.

On November 8, 2018, we amended certain terms of the Nucynta Commercialization Agreement, which eliminated the $135.0 million guaranteed minimum annual royalties and adjusted the royalty structure such that beginning on January 1, 2019, we were obligated to make royalty payments to Assertio conditional upon net sales.

Nucynta ER is an extended-release formulation of tapentadol that is indicated for the management of pain severe enough to require daily, around-the-clock, long term opioid treatment, and for which alternate treatment options are inadequate.

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Nucynta IR is an immediate-release formulation of tapentadol that is indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults.

Nucynta ER and Nucynta IR are the only tapentadol-based products marketed in the US and the drug substance is patent-protected.

Nucynta ER and Nucynta IR are the only tapentadol-based products marketed in the United States and the drug substance is patent-protected.

Nucynta ER’s label includes data from separate clinical trials that demonstrate its efficacy in improving pain intensity for patients suffering from chronic low back pain and neuropathic pain associated with diabetic peripheral neuropathy.

Nucynta IR’s label includes data from a clinical trial that demonstrates its efficacy in improving pain intensity for post-surgical acute pain.

On January 9, 2018, we amended the Nucynta Commercialization Agreement and consummated the transactions contemplated thereby.

On February 13, 2020, we closed the Nucynta Acquisition.

We began shipping and recognizing product sales on the Nucynta Products on January 9, 2018 and we began commercial promotion of the Nucynta Products in February 2018.

On November 8, 2018, we amended certain terms of the Nucynta Commercialization Agreement, which eliminated the $135.0 million guaranteed minimum annual royalties and adjusted the royalty structure such that beginning on January 1, 2019, our obligation to make royalty payments to Assertio became conditional solely upon net sales.

Our prior royalty obligation to Assertio ceased and our only remaining royalty obligation is to pay 14% of net sales of the Nucynta Products directly to Grünenthal Gmbh under the Grünenthal License.

Manufacturing of Our Products

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This process is reproducible, scalable and cost-efficient, and we believe that the microsphere formulation — and the related manufacturing process — is unique in the extended-release opioid market.

To date, we have produced Xtampza ER at a contract manufacturing organization, Patheon, a subsidiary of Thermo Fisher Scientific, Inc.

To date, we have produced Xtampza ER through a contract manufacturing organization, Patheon, a subsidiary of Thermo Fisher Scientific, Inc.

Our microsphere production is currently conducted in an area of the manufacturing plant that is shared with other clients.

We are in the process of building out a dedicated manufacturing suite within the same Patheon site.

Patheon has an established record of manufacturing products approved in the United States, including products containing controlled substances.

We own all of the intellectual property, including know - how and specialized manufacturing equipment, necessary to be able to replicate the manufacturing equipment currently located at Patheon’s facility at an alternative location (and with an alternative vendor) if necessary.

We have completed the build-out of a dedicated manufacturing suite within the same Patheon site and will be transitioning production to the new suite.

Patheon has an established

record of manufacturing FDA-approved products in the United States, including products containing controlled substances.

We own all of the intellectual property, including know - how and specialized manufacturing equipment, necessary to be able to qualify the manufacturing equipment currently located at Patheon’s facility as an alternative location (and with an alternative vendor) if necessary.

Pursuant to the Nucynta Commercialization Agreement, Assertio was historically responsible for manufacturing and delivering to us the Nucynta Products for commercialization in the United States.

As part of our partnership with Assertio, we participated in a Joint Manufacturing Steering Committee with our counterparts at Assertio, through which we take part in decisions regarding the commercial manufacturing of the Nucynta Products.

As part of our partnership with Assertio, we participated in a Joint Manufacturing Steering Committee with our counterparts at Assertio, through which we took part in decisions regarding the commercial manufacturing of the Nucynta Products.

Effective upon the closing of the Nucynta Acquisition, we assumed responsibility for manufacturing the Nucynta Products for commercialization in the United States.

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

At the time of closing of the Nucynta Acquisition, Assertio had initiated a technology transfer to enable manufacturing of Nucynta ER at Patheon;

At the time of closing of the Nucynta Acquisition, Assertio had initiated a technology transfer to enable manufacturing of Nucynta ER at Patheon in Cincinnati, Ohio;

we have assumed responsibility for completing such technology transfer in connection with the Nucynta Acquisition.

Nucynta is produced at a contract manufacturing organization, Cambrex, pursuant to a manufacturing and supply agreement that we assumed from Assertio in connection with the Nucynta Acquisition.

Nucynta IR is produced at a contract manufacturing organization, Cambrex, pursuant to a manufacturing and supply agreement that we assumed from Assertio in connection with the Nucynta Acquisition.

Drug Substances

The active pharmaceutical ingredient to formulate Xtampza ER is oxycodone base, which presents as myristate salt in the Xtampza ER formulation.

The active pharmaceutical ingredient used to formulate Xtampza ER is oxycodone base, which presents as myristate salt in the Xtampza ER formulation.

We currently procure this active pharmaceutical ingredient pursuant to a supply agreement with a single U.S.

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

Accordingly, Xtampza ER and the Nucynta Products are classified by the DEA as Schedule II controlled substances, meaning that they have a high potential for abuse and dependence among drugs that are recognized as having an accepted medical use.

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

Consequently, the manufacturing, shipping, dispensing and storing of our products are subject to a high degree of regulation, as described in more detail under the caption “— Governmental Regulation — DEA and Opioid Regulation.”

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We commercialize Xtampza ER and the Nucynta Products in the United States with a dedicated field sales force, consisting of approximately 145 sales representatives and managers, to call on the approximately 11,000 health care professionals who write approximately 65% of the branded extended-release opioid prescriptions in the United States, with a primary focus on pain specialists.

In addition, we employ medical science liaisons to respond to clinician inquiries about Xtampza ER and the Nucynta Products.

In addition, we employ medical science liaisons who engage in peer-to-peer medical science education with respect to pain and opioid pain therapy and respond to clinician inquiries about Xtampza ER and the Nucynta Products.

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

We have developed positioning and messaging campaigns, a publication strategy, initiatives with payor organizations, and distribution and national accounts strategies.

Our marketing strategy focuses on increasing awareness of the differentiated features of Xtampza ER and the Nucynta Products.

We primarily sell our products to wholesalers, retail drug store chains, supermarket chains, mass merchandisers, distributors, mail order accounts, hospitals and government agencies.

Our wholesalers and distributors purchase products

from us and, in turn, supply products to retail drug store chains, independent pharmacies and managed health care organizations.

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.

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.

Customers in the managed health care market include health maintenance organizations, nursing homes, hospitals, clinics, pharmacy benefit management companies and mail order customers.

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The protection of patents, designs, trademarks and other proprietary rights that we own or license is critical to our success and competitive position.

Xtampza ER is protected by seventeen issued patents in the United States (which cover both the abuse-deterrent technology and methods of using it to treat patients), one granted and two pending applications in the European Patent Office, two issued patents in Canada, and one issued patent in each of Japan and Australia.

Xtampza ER is protected by nineteen issued patents in the United States (which cover both the abuse-deterrent technology and methods of using it to treat patients), one granted and two pending applications in the European Patent Office, two issued patents in Canada, and one issued patent in each of Japan and Australia.

Finally, we have six patent applications pending in the United States, one pending patent application in each of Canada and Japan, and one pending PCT application.

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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.

We also depend upon the skills, knowledge and experience of our scientific and technical personnel, as well as that of our advisors, consultants and other contractors.

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.

To help protect our proprietary know-how that is not patentable, we rely on trade secret protection and confidentiality agreements to protect our interests.

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

Currently, the only extended-release opioid drugs on the market that have an abuse-deterrent product label, in addition to Xtampza ER, are OxyContin and Hysingla®, both from Purdue, and MorphaBond ER from Daiichi Sankyo.

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.

Currently, the only extended-release opioid drugs on the market that have an abuse-deterrent product label, in addition to Xtampza ER, are OxyContin and Hysingla®, both from Purdue.

Hysingla is a once a day hydrocodone product.

MorphaBond ER is a twice daily morphine product formulated with a hard tablet and gelling polymers.

In addition, there are two other extended-release opioid drugs with abuse deterrent product labeling that are not currently marketed:

Arymo from Zyla and Embeda from Pfizer.

Other companies have products indicated for the treatment of moderate to severe, around-the-clock, long-term pain for which alternative treatments are not available, but these products do not have abuse-deterrent claims in their labels, including Pernix and Mallinckrodt, as well as several generic companies.

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

Xtampza ER may also face competition from commercially available generic and branded extended-release and long-acting opioid drugs other than oxycodone, including fentanyl, hydromorphone, oxymorphone and methadone, as well as opioids that are currently in clinical development, including a generic version of Xtampza ER for which Teva recently submitted an Abbreviated New Drug Application (“ANDA”) to the FDA and which is the subject of patent infringement litigation filed by us in February 2018.

Xtampza ER may also face competition from commercially available generic and branded extended-release and long-acting opioid drugs other than oxycodone, including morphine sulfate, fentanyl, hydromorphone, oxymorphone and methadone, as well as opioids that are currently in clinical development, including a generic version of Xtampza ER for which Teva submitted an Abbreviated New Drug Application (“ANDA”) to the FDA.

Pursuant to a settlement we reached with Teva in September 2020, we agreed to grant Teva a license to market its generic version of Xtampza ER in the United States beginning on or after September 2, 2033 (subject to FDA approval and acceleration under certain circumstances).

As a result of the settlement, Teva agreed to a consent judgment confirming that its proposed generic products infringe upon our asserted patents and that those patents are valid and enforceable with respect to Teva’s proposed generic products.

For more information regarding the settlement, please refer to Note 11, Commitments and Contingencies .

Xtampza ER competes against all extended-release opioids, including Purdue’s OxyContin and its authorized generics.

Although no generic oxycodone extended-release products are currently commercially available, it is possible that generic forms of OxyContin could become available, in which case Xtampza ER would compete with any such generic oxycodone extended-release products.

Although Purdue lists 19 patents for OxyContin in the Orange Book, of which 10 list expiration dates between 2027 and 2030, it is possible that generic forms of OxyContin could become available sooner, in which case Xtampza ER would compete with any such generic oxycodone extended-release products, in addition to all other extended-release opioids and their respective generics.

The Nucynta Products

Nucynta ER competes against other long-acting opioid medications, including:

Nucynta IR competes primarily against short-acting opioids used for the management of acute pain in adults severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Nucynta ER competes primarily against other long-acting opioid medications, including:

and Hysingla.

Nucynta ER may also face competition from commercially available generic and branded extended-release and long-acting opioid drugs including oxycodone, morphine sulfate, fentanyl, hydromorphone, oxymorphone and methadone.

Nucynta IR competes primarily against short-acting opioids used for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults.

There are numerous such medicines, including:

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● satisfactory completion of an FDA pre - approval inspection of the facility or facilities at which the product is manufactured to assess compliance with the FDA’s cGMP regulations;

● submission to the FDA of an NDA;

● satisfactory completion of a potential review by an FDA advisory committee, if applicable;

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

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

● FDA review and approval of the NDA.

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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 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 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 is submitted.

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Sponsors of clinical trials generally must register and report key parameters of certain clinical trials at the NIH - maintained website ClinicalTrials.gov.

For 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.

There are four categories of abuse-deterrence studies and clinical trials:

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.

FDA approval of the NDA is required before marketing of the product may begin in the United States.

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 (the FDA conducts a preliminary review of all NDAs within the first 60 days after submission before accepting them for filing), depending on the nature of the drug.

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

The FDA may refer applications for novel drug products, or drug products that present

difficult questions of safety or efficacy, to an advisory committee — typically a panel that includes clinicians and other experts — for review, evaluation, and a recommendation as to whether the application should be approved and under what conditions.

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

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

The FDA may refer applications for novel drug products, or drug products that present difficult questions of safety or efficacy, to an advisory committee — typically a panel that includes clinicians and other experts — for review, evaluation, and a recommendation as to whether the application should be approved and under what conditions.

The FDA is not bound by the recommendation of an advisory committee, but it generally follows such recommendations.

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If the FDA determines it cannot approve the NDA in its current form, it will issue a complete response letter indicating that the application will not be approved in its current form.

The complete response letter usually describes the specific deficiencies that the FDA identified in the application and may require additional clinical or other data or impose other conditions that must be met in order to obtain approval of the NDA.

Addressing the deficiencies noted by the FDA could be impractical, and it is possible that the sponsor could withdraw its application or approval may not be obtained or may be costly and may result in significant delays prior to approval.

The complete response

letter usually describes the specific deficiencies that the FDA identified in the application and may require additional clinical or other data or impose other conditions that must be met in order to obtain approval of the NDA.

After receiving a complete response letter, the applicant may resubmit the application addressing all deficiencies in the letter or withdraw the application.

Addressing the deficiencies noted by the FDA can be costly and can result in significant delays prior to approval.

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 an sNDA.

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As with an NDA, if the FDA determines that it cannot approve an sNDA in its current form, it will issue a complete response letter as discussed above.

The FDA has the authority to require a Risk Evaluation and Mitigation Strategy (“REMS”) as a condition of the approval of an NDA or after approval to ensure that the benefits of a drug outweigh its risks.

The FDA has the authority to require a Risk Evaluation and Mitigation Strategy (“REMS”), either as a condition of the approval of an NDA or after approval to ensure that the benefits of a drug outweigh its risks.

If the FDA determines a REMS is necessary for a new drug, the drug sponsor must submit a proposed REMS plan as part of its NDA prior to approval.

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A REMS can include medication guides, communication plans for healthcare professionals, and Elements To Assure Safe Use (“ETASU”).

In addition, the REMS must include a timetable to periodically assess 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.

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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 of the existence of the REMS and the need to successfully complete the necessary training.

Prescriber training required 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.

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

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

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

In September 2018, and pursuant to its Opioids Action Plan, the FDA approved the final class-wide REMS, which includes several measures to facilitate communication of the risks associated with opioid pain medications to patients and health care professionals and, for the first time, applies to immediate-release and extended-release/long-acting opioid analgesics intended for use in an outpatient setting.

The new REMS requires that training be made available to health care providers who are involved in the management of patients with pain (including nurses and pharmacists), and not only to prescribers, and requires that the education cover broader information about appropriate pain management, including alternatives to opioids for the treatment of pain.

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

The REMS requires that training be made available to health care providers who are involved in the management of patients with pain (including nurses and pharmacists) and requires that the education cover broad information about appropriate pain management, including alternatives to opioids for the treatment of pain.

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.

Advertising and Promotion

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After approval, product promotion can include only those claims relating to safety and efficacy that are consistent with the labeling approved by the FDA.

Healthcare providers are permitted to prescribe drugs for “off-label” uses — that is, uses not approved by the FDA and therefore not described in the drug’s labeling — because the FDA does not regulate the practice of medicine.

Healthcare providers are permitted to prescribe drugs for “off-label” uses — that is, uses not approved by the FDA and therefore not described in

the drug’s labeling — because the FDA does not regulate the practice of medicine.

However, FDA regulations impose stringent restrictions on manufacturers’ communications regarding off-label uses.

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

The FDA may require post-approval studies and clinical trials if the FDA finds that scientific data, including information regarding related drugs, deem it appropriate.

The purpose of such studies would be to assess a known serious risk or signals of serious risk related to the drug or to identify an unexpected serious risk when available data indicate the potential for a serious risk.

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

The FDA may also require a labeling change if it becomes aware of new safety information that it believes should be included in the labeling of a drug.

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Orange Book Listing

In seeking approval for a drug through an NDA, applicants are required to list with the FDA each patent whose claims cover the applicant’s product.

In seeking approval for a drug through an NDA, applicants are required to list with the FDA each patent with claims that cover the applicant’s product.

Upon approval of a drug, each of the patents listed in the application for the drug is then published in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book.

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(ii) the listed patent has expired;

(iii) the listed patent has not expired, but will expire on a particular date

and approval is sought after patent expiration;

(iii) the listed patent has not expired, but will expire on a particular date and approval is sought after patent expiration;

or (iv) the listed patent is invalid or will not be infringed by the new product.

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A certification that the new product will not infringe the already approved product’s listed patents, or that such patents are invalid, is called a Paragraph IV certification.

If the ANDA applicant has provided a Paragraph IV certification to the FDA, the applicant must also send notice of the Paragraph IV certification to the NDA and patent holders once the ANDA has been accepted for filing by the FDA.

If the ANDA applicant has provided a Paragraph IV certification to the

FDA, the applicant must also send notice of the Paragraph IV certification to the NDA and patent holders once the ANDA has been accepted for filing by the FDA.

The NDA and patent holders may then initiate a patent infringement lawsuit in response to the notice of the Paragraph IV certification.

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.

The ANDA application also will not be approved until any applicable non - patent exclusivity listed in the Orange Book for the referenced product has expired.

For further detail regarding our litigation with Teva regarding the ANDA filed by Teva relating to Xtampza ER, refer to “Item 3.

For further detail regarding our litigation with Teva with respect to Teva’s ANDA relating to Xtampza ER, refer to “Item 3.

Legal Proceedings”.

Upon NDA approval of a new chemical entity (“NCE”), which is a drug that contains no active moiety that has been approved by FDA in any other NDA, that drug receives five years of marketing exclusivity during which 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 regarding that drug.

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 FDA in any other NDA, that drug receives five years of marketing exclusivity during which 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 regarding that 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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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.

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

Generally, drug products obtain FDA marketing approval pursuant to an NDA or an ANDA.

A third alternative is a Section 505(b)(2) NDA, which enables the applicant to rely, in part, on data not developed by the applicant, such as the FDA’s findings of safety and efficacy in the approval of a similar product or published literature in support of its application.

Section 505(b)(2) NDAs may provide an alternate path to FDA approval for new or improved formulations or new uses of previously approved products.

Section 505(b)(2) permits the filing of an NDA where at least some of the information required for approval comes from clinical trials not conducted by, or for, the applicant and for which the applicant has not obtained a right of reference.

The FDA may then approve the new product candidate for all, or some, of the label indications for which the referenced product has been approved, as well as for any new indication sought by the Section 505(b)(2) applicant.

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.

Under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, in lieu of developing all of the information normally required for approval of an NDA, an applicant may rely, in part, on data developed by another party and for which the applicant has not obtained a right of reference.

Most commonly, 505(b)(2) applicants rely on the FDA’s findings of safety and efficacy in a prior approval of a similar product (although they may also rely on information in published literature).

A 505(b)(2) application that references a prior approval may seek approve 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.

Thus approval of a Section 505(b)(2) NDA can be stalled until all the listed patents claiming the referenced product have expired;

until any non-patent exclusivity, such as exclusivity for obtaining approval of a NCE, listed in the Orange Book for the referenced product has expired;

until any non-patent exclusivity listed in the Orange Book for the referenced product has expired;

and, in the case of a Paragraph IV certification and subsequent patent infringement suit, until the earlier of 30 months, settlement of the lawsuit or a decision in the infringement case that is favorable to the Section 505(b)(2) applicant.

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Tentative approval indicates that the FDA has determined that the applicant meets the standards for approval as of the date that the tentative approval is granted.

Final regulatory approval can only be granted if the FDA is assured that there is no new information that would affect final

regulatory/ approval.

Final regulatory approval can only be granted if the FDA is assured that there is no new information that would affect final regulatory approval.

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.

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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 is listed by the DEA as a Schedule II controlled substance under the CSA.

The Nucynta Products are also listed by the DEA as Schedule II controlled substances under the CSA.

Xtampza ER and the Nucynta Products are listed by the DEA as a Schedule II controlled substance under the CSA.

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

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For example, 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 registration is required for any facility that manufactures, distributes, dispenses, imports or exports any controlled substance.

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.

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In October 2019, the DEA proposed additional regulations to amend the manner in which the agency grants quotas to manufacturers.

The proposed regulations will establish use-specific quotas, including commercial sales, product development, transfer, replacement and packaging.

If finalized, the proposed regulations will establish use-specific quotas, including commercial sales, product development, transfer, replacement and packaging.

To decrease the risk of diversion and increase accountability, inventory allowances will be reduced, and procurement quota certifications will be required.

In April 2020 in response to the COVID-19 pandemic, the DEA adjusted the established 2020 aggregate production quotas and assessment of annual needs for select Schedule II substances.

The DEA took this action to ensure that the country has an adequate and uninterrupted supply of these substances during the public health emergency.

Distributions of any Schedule I or II controlled substance must also be accompanied by special order forms, with copies provided to the DEA.

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We and our contract manufacturers must receive an annual quota from the DEA in order to produce or procure any Schedule I or Schedule II substance, including oxycodone base for use in manufacturing Xtampza ER.

In addition, Assertio and its contract manufacturers must receive an annual quota from the DEA in order to produce or procure tapentadol for use in manufacturing the Nucynta Products.

In addition, we and our contract manufacturers must receive an annual quota from the DEA in order to produce or procure 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.

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.

A compliant suspicious order monitoring system includes well-defined due diligence, “know your customer” efforts and order monitoring.

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We and our contract manufacturers are subject to state regulation on distribution of these products.

Two new federal laws address the national epidemics of prescription opioid abuse and illicit opioid use.

First, passed in 2016, CARA expands the availability of naloxone for law enforcement and other first responders, forms an interagency task force to develop best practices for pain management with opioid medications and provides resources to improve state monitoring of opioids.

The SUPPORT Act, which was signed into law in November 2018, includes a number of measures directed towards regulation and improvement of treatment for substance use-disorder and increased coverage by CMS of medically-assisted treatment options.

Federal laws have been enacted to address the national epidemics of prescription opioid abuse and illicit opioid use.

In 2016, the Comprehensive Addiction and Recovery Act (“CARA”), was enacted to address the national epidemics of prescription opioid abuse and heroin use.

CARA expands the availability of naloxone for law enforcement and other first responders, forms an interagency task force to develop best practices for pain management with opioid medications and provides resources to improve state monitoring of opioids.

The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (“SUPPORT Act”), which was signed into law in November 2018, includes a number of measures directed towards regulation and improvement of treatment for substance use-disorder and increased coverage by CMS of medically-assisted treatment options.

In addition, the SUPPORT Act requires HHS to report to Congress on existing barriers to access to abuse-deterrent opioid formulations by Medicare Part C and D beneficiaries.

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These laws are potentially applicable to us as both a manufacturer and a supplier of products and they also apply to hospitals, physicians and other potential purchasers of our products.

The applicable federal fraud abuse laws apply to products or services reimbursed by federal healthcare programs.

The applicable federal fraud and abuse laws apply to products or services reimbursed by federal healthcare programs.

Some states, however, have applicable fraud and abuse laws that apply more broadly to include products or services reimbursed by private payors.

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Failure to comply with required reporting requirements under these laws could subject manufacturers and others to substantial civil money penalties.

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.

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.

Third-Party Payor Coverage and Reimbursement

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

● establishment of a Center for Medicare Innovation at CMS to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug spending that began on January 1, 2011.

● establishment of a Center for Medicare Innovation at CMS in January 2011 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.

On December 14, 2018, a Texas U.S.

District Court Judge ruled that the Affordable Care Act is unconstitutional in its entirety because the “individual mandate” was repealed by Congress.

On December 18, 2019, the Fifth Circuit U.S.

Court of Appeals held that the individual mandate is unconstitutional and remanded the case to the Texas District Court to reconsider its earlier invalidation of the entire Affordable Care Act.

An appeal was taken to the U.S.

Supreme Court which heard oral arguments in the case on November 10, 2020.

A ruling is expected in 2021.

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

The Budget Control Act of 2011, among other things, created the Joint Select Committee on Deficit Reduction to recommend proposals in spending reductions to Congress.

The Joint Select Committee on Deficit Reduction did not achieve its targeted deficit reduction of at least $1.2 trillion for the years 2012 through 2021, triggering the legislation’s automatic reductions to several government programs.

These reductions include aggregate reductions to Medicare payments to providers of up to 2% per fiscal year, which went into effect in April 2013 and, due to the Bipartisan Budget Act of 2015, will remain in effect through 2025 unless additional action is taken by Congress.

In January 2013, President Obama signed into law the American Taxpayer Relief Act of 2012, which, among other things, 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 Joint Select Committee on Deficit Reduction (created under the Budget Control Act of 2011) did not achieve its targeted deficit reduction of at least $1.2 trillion for the years 2012 through 2021, triggering automatic reductions to several government programs, including aggregate reductions to Medicare payments to providers of up to 2% per fiscal year, which will remain in effect through 2030 unless additional action is taken by Congress (although they have been suspended by the Coronavirus Aid, Relief and Economic Security, or CARES, Act, until March 31, 2021).

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.

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.

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In each of these areas, as above, the FDA and other regulatory authorities have broad regulatory and enforcement powers, including, among other things, the ability to levy fines and civil penalties, suspend or delay issuance of approvals, seize or recall products, and withdraw approvals, any one or more of which could have a material adverse effect on us.

Employees and Human Capital Resources

Investing in, developing, and maintaining human capital is critical to our success.

As of December 31, 2020, we had a total of 234 full-time employees.

We emphasize a number of measures and objectives in managing our human capital assets, including, among others, employee safety and wellness;

talent acquisition and retention;

employee engagement,

development, and training;

diversity and inclusion;

and compensation and pay equity.

None of our employees are represented by a labor organization or under any collective-bargaining arrangements.

We consider our employee relations to be good.

Our human capital resources objectives include, as applicable, identifying, recruiting, retaining, incentivizing and integrating our existing and new employees, advisors and consultants.

The principal purposes of our equity and cash incentive plans are to attract, retain and reward personnel through the granting of stock-based and cash-based compensation awards, in order to increase stockholder value and the success of our company by motivating such individuals to perform to the best of their abilities and achieve our objectives.

The success of our business is fundamentally connected to the well-being of our employees.

Accordingly, we are committed to their health, safety and wellness.

We provide our employees and their families with access to a variety of innovative, flexible and convenient health and wellness programs, including benefits that provide protection and security so they can have peace of mind concerning events that may require time away from work or that impact their financial well-being;

that support their physical and mental health by providing tools and resources to help them improve or maintain their health status and encourage engagement in healthy behaviors;

and that offer choice where possible so they can customize their benefits to meet their needs and the needs of their families.

In response to the COVID-19 pandemic, we implemented significant changes that we determined were in the best interest of our employees, as well as the community in which we operate, and which comply with government regulations.

This includes us allowing our employees to work from home, while implementing additional safety measures for employees who chose to work on-site.

Executive Officers of the Company

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Alison Fleming

Executive Vice President and Chief Technology Officer

Executive Vice President and Chief Technical Officer

Paul Brannelly

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in 2000, both from Rutgers, The State University of New Jersey.

Alison Fleming, Ph.D., Chief Technology Officer .

Fleming has served as our Executive Vice President and Chief Technology Officer since January 2017.

Prior to being our Chief Technology Officer, Dr.

Fleming led our development team as our Vice President, Product Development since October 2002.

Alison Fleming, Ph.D., Chief Technical Officer .

Fleming has served as our Executive Vice President and Chief Technical Officer since January 2017.

Prior to being our Chief Technical Officer, Dr.

Fleming led our development team

as our Vice President, Product Development since October 2002.

Prior to joining us, Dr.

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Prior to joining us, Mr.

Brannelly served as Senior Vice

President, Finance and Administration, and Treasurer of Karyopharm Therapeutics Inc., a biopharmaceutical company, from June 2013 to August 2014.

Brannelly served as Senior Vice President, Finance and Administration, and Treasurer of Karyopharm Therapeutics Inc., a biopharmaceutical company, from June 2013 to August 2014.

From August 2014 to November 2014, Mr.

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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.

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We maintain a website at www.collegiumpharma.com.

soon as reasonably practicable after we electronically file those reports with, or furnish them to, the Securities and Exchange Commission (“SEC”).

We make available, free of charge on our website, our Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and all amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended (“Exchange Act”), as soon as reasonably practicable after we electronically file those reports with, or furnish them to, the Securities and Exchange Commission (“SEC”).

We also make available, free of charge on our website, the reports filed with the SEC by our officers, directors and 10% shareholders pursuant to Section 16 under the Exchange Act as soon as reasonably practicable after copies of those filings are provided to us by those persons.

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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