−Removed: We are building a leading, diversified specialty pharmaceutical company committed to improving the lives of people living with serious medical conditions.
+Added: Our mission is to build a leading, diversified specialty pharmaceutical company committed to improving the lives of people living with serious medical conditions.
+Added: 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.
−Removed: Xtampza ER, an abuse-deterrent, oral formulation of oxycodone, was approved by the U.S.
−Removed: 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.
−Removed: We commercially launched Xtampza ER in June 2016.
−Removed: The Nucynta Products are extended-release (“ER”) and immediate-release (“IR”) formulations of tapentadol.
−Removed: 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.
−Removed: 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.
−Removed: We began shipping and recognizing product sales on the Nucynta Products in January 2018 and began marketing the Nucynta Products in February 2018.
+Added: 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.
+Added: Xtampza ER is an abuse-deterrent, extended-release, oral formulation of oxycodone.
+Added: 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).
+Added: This technology combines an active opioid ingredient with a fatty acid and waxes to form microspheres that are filled into a capsule.
+Added: These wax-based microspheres are designed to resist particle size reduction and dose dumping when subjected to physical and chemical manipulation.
+Added: In April 2016, the United States Food and Drug Administration (“FDA”) approved our New Drug Application (“NDA”) for Xtampza ER.
+Added: 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.
+Added: 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.
+Added: Xtampza ER’s label indicates a dosing regimen of one capsule every 12 hours, and it must be taken with food.
+Added: In June 2016, we commercially launched Xtampza ER in the United States.
+Added: 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.
+Added: 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.
+Added: 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).
+Added: 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;
+Added: crushed OxyContin was bioequivalent to crushed oxycodone IR.
+Added: 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.
+Added: We are committed to ongoing monitoring and public dissemination of our real-world abuse and diversion data, regardless of the results.
+Added: The two main sources of real-world abuse, misuse, and diversion data are RADARS® and Inflexxion, an IBH Company.
+Added: 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.
+Added: Abuse, misuse, and diversion of Xtampza ER has remained low compared to commonly abused
+Added: schedule II opioid analgesics for three years after introduction into the U.S.
+Added: 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.
+Added: Potential limitations are based upon the fact that the Poison Center and Treatment Center Program cases involve self-reporting which may lead to:
+Added: (i) differential misidentification among drug groups which may affect observed differences, and (ii) case counts of drug groups comprised primarily of branded products (other abuse-deterrent formulations of ER opioids) may be overestimated when based on self-reporting and drug groups comprised primarily of generic products (non-abuse-deterrent formulations of ER opioids and IR oxycodone) may be underestimated.
+Added: The RADARS data represents a single snapshot in time and is subject to change.
+Added: Therefore, we plan to continue monitoring real world data characterizing the rate of abuse, misuse, and diversion of Xtampza.
+Added: Nucynta Products
+Added: The Nucynta Products are extended-release (“ER”) and immediate-release (“IR”) oral formulations of tapentadol.
+Added: In November 2008, the FDA approved Nucynta ER and Nucynta IR.
+Added: Nucynta ER is indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic, including neuropathic pain associated with diabetic peripheral neuropathy in adults, and for which alternate treatment options are inadequate.
+Added: 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 and pediatric patients aged 6 years and older with a body weight of at least 40 kg.
+Added: In August 2023, the FDA granted New Patient Population exclusivity for Nucynta IR in pediatric patients.
+Added: This grant extended the period of U.S.
+Added: exclusivity for Nucynta IR from June 27, 2025 to July 3, 2026.
+Added: We began commercializing the Nucynta Products in 2018 pursuant to a commercialization agreement (the “Nucynta Commercialization Agreement”) with Assertio Therapeutics, Inc.
+Added: (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.
+Added: 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”).
+Added: Upon closing the Nucynta Acquisition, the Nucynta Commercialization Agreement and our prior royalty obligation to Assertio ceased;
+Added: 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.
+Added: Belbuca and Symproic
On March 22, 2022, we acquired BioDelivery Sciences International, Inc.
−Removed: (“BDSI”), a specialty pharmaceutical company working to deliver innovative therapies for individuals living with serious and debilitating chronic conditions, pursuant to an Agreement and Plan of Merger, dated as of February 14, 2022, by and among us, Bristol Acquisition Company Inc., our wholly owned subsidiary, and BDSI (the “BDSI Acquisition”).
−Removed: Upon closing, we acquired the Belbuca, Symproic, and Elyxyb products.
−Removed: We began shipping and recognizing product sales related to Belbuca, Symproic, and Elyxyb in March 2022.
−Removed: Belbuca is a buccal film that contains buprenorphine, a Schedule III opioid, and was approved by the FDA in October 2015 for use in patients with pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative options are inadequate.
+Added: (“BDSI”), a specialty pharmaceutical company working to deliver innovative therapies for individuals living with serious and debilitating chronic conditions (the “BDSI Acquisition”).
+Added: Upon closing the BDSI Acquisition, we acquired Belbuca and Symproic.
+Added: Belbuca is a buccal film that contains buprenorphine, a Schedule III opioid, and was approved by the FDA in October 2015 for severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative options are inadequate.
Symproic was approved by the FDA in March 2017 for the treatment of opioid-induced constipation (“OIC”) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.
−Removed: Elyxyb was approved by the FDA in May 2020 for the acute treatment of migraine with or without aura in adults.
−Removed: We discontinued commercialization of Elyxyb in the fourth quarter of 2022 and transferred that product, together with related assets and liabilities, to a third party in the first quarter of 2023.
−Removed: For the fiscal year ended December 31, 2022, we generated $463.9 million in net revenues across our portfolio.
+Added: We began shipping and recognizing product sales related to Belbuca and Symproic in March 2022.
Pain, Pain Management, and Opioid Abuse in the United States
2 unchanged sentences
There are two broad categories of pain based on duration:
−Removed: acute pain, or pain that is self-limited and generally requires treatment for no more
−Removed: than up to a few weeks, and chronic pain, or pain that lasts beyond the healing of an injury or that persists longer than 3-6 months.
+Added: 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.
2 unchanged sentences
A 2011 report from the Institute of Medicine estimated that chronic pain costs the U.S.
−Removed: 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.
+Added: 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
+Added: 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.
1 unchanged sentence
Prescription opioids continue to serve as important tools in the treatment of acute and chronic pain where alternative treatments have been inadequate.
−Removed: Prescription opioids are available in immediate-release formulations as well as in extended-release formulations, which incorporate a time-release mechanism designed to deliver steady amounts of opioid, typically over 12 to 24 hours.
+Added: Prescription opioids are available in immediate-release formulations as well as in long-acting/extended-release formulations, which incorporate a time-release mechanism designed to deliver steady amounts of opioid, typically over 12 to 24 hours.
Extended-release opioids are designed to offer more convenient dosing with a longer period of consistent blood levels of the active drug as compared to immediate-release formulations.
−Removed: In 2022, there were approximately 145.1 million prescriptions for opioids written in the United States, representing a 5% decline from 2021 levels and including approximately 2.6 million prescriptions for branded extended-release opioids, approximately 11.6 million prescriptions for generic extended-release opioids, and approximately 130.9 million prescriptions for immediate-release opioids.
−Removed: After marked increases in opioid prescriptions from 2000 to 2015, prescriptions have decreased each year since 2015, correlating with rising awareness of the extent and impact of the opioid crisis.
−Removed: Indeed, prescription levels in 2020 returned to levels similar to those seen in the year 2000, when 143.8 million prescriptions for opioids were written in the United States, including 11.4 million prescriptions for extended-release opioids and 132.4 million prescriptions for immediate-release opioids.
+Added: In 2023, there were approximately 139.7 million prescriptions for opioids written in the United States, representing a 3.8% decline from 2022 levels and including approximately 13.6 million prescriptions for long-acting/extended-release opioids, and approximately 126.1 million prescriptions for immediate-release opioids.
+Added: After marked increases in opioid prescriptions from 2000 to 2015, prescriptions decreased each year since 2015, correlating with rising awareness of the extent and impact of the opioid crisis.
+Added: However, prescription levels in 2020 returned to levels similar to those seen in the year 2000, when 143.8 million prescriptions for opioids were written in the United States, including 11.4 million prescriptions for extended-release opioids and 132.4 million prescriptions for immediate-release opioids.
Increasingly, practitioners and regulators are focusing on multidisciplinary, multimodal approaches to pain management, including exercise, physical therapy and psychotherapy, and opioid and non-opioid medications.
6 unchanged sentences
The beginning of the opioid overdose epidemic in the late 1990s was marked by a rise in prescription opioid overdose deaths.
−Removed: 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.
+Added: 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.
Meanwhile, the predominant opioid cause of death in 2018 involved synthetic opioids other than methadone.
While opioid-related overdose deaths declined slightly in 2018 (in contrast to the sharp increases during 2014 to 2017), the number of drug overdose deaths was still four times higher in 2018 than in 1999.
−Removed: The emergence of COVID-19 in early 2020 raised fears that already-rising drug overdose deaths could surge even further amid social isolation, economic stress, and disrupted access to treatment facilities and providers.
−Removed: Prior research showed that overdose deaths immediately spiked to previously unseen levels after the COVID-19 pandemic began to impact the United States domestically in March 2020 and stayed elevated throughout the summer of 2020.
−Removed: The Department of Health and Human Services (“HHS”) estimates that in 2022, 10.1 million Americans misused prescription opioids in the last year, 1.6 million had an opioid use disorder, and more than 48,000 died from overdosing on synthetic opioids other than methadone.
Despite heightened awareness of the risks associated with opioid use, abuse of prescription opioids, including extended-release formulations, continues to be a public health issue.
+Added: In 2022, 8.9 million, or 3.2% 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”).
+Added: In 2021, the number of reported deaths involving prescription opioids totaled 16,706, worsening from 2019 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”).
3 unchanged sentences
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.
−Removed: These technologies, however, do not eliminate the possibility of misuse and abuse.
+Added: These technologies, however, do not eliminate the possibility of
+Added: 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.
1 unchanged sentence
In response to widespread prescription opioid abuse, the U.S.
−Removed: government and a number of state legislatures have in recent years enacted new legislation and regulations intended to fight the opioid epidemic.
−Removed: 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.
+Added: government and a number of state legislatures enacted new legislation and regulations intended to fight the opioid epidemic.
+Added: 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 clinical practice 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.
On November 4, 2022, the CDC released updated guidance on prescribing opioids for pain.
The 2022 prescribing guidelines replaced the 2016 guidelines but retained their principles for prescribing opioids for chronic pain.
−Removed: The newly updated CDC guidelines note that although opioids should not be considered first-line therapy for pain management, this does not mean that patients should be required to sequentially fail nonpharmacologic and nonopioid therapy before proceeding to opioid therapy, but rather the expected benefits specific to the clinical context should be weighed against risks before initiating therapy.
−Removed: In addition to CDC, the Department of Health and Human Services (“HHS”) provided guidance to clinicians initiating a reduction in opioid dosage or discontinuation of long-term opioid therapy for chronic pain.
+Added: The updated CDC guidelines note that although opioids should not be considered first-line therapy for pain management, this does not mean that patients should be required to sequentially fail nonpharmacologic and nonopioid therapy before proceeding to opioid therapy, but rather the expected benefits specific to the clinical context should be weighed against risks before initiating therapy.
+Added: In addition to CDC, the Department of Health and Human Services (“HHS”), and the Department of Veterans Affairs and the Department of Defense (“VA-DoD”) issued clinical practice guidelines in 2017 and updated most recently in 2022 for the evaluation and management of care for patients with chronic pain who are on or being considered for opioid treatment.
+Added: These guidelines are grounded in patient-centered care and the 2022 update provides algorithms for determining the appropriateness of opioids for chronic pain, determining the initiation of opioids, and maintaining, tapering, discontinuing or switching from full agonist opioid treatment.
While much, if not most, of the state level efforts have focused primarily on increasing people’s access to substance abuse treatment and harm reduction measures, some initiatives more directly impact manufacturers and distributors of prescription opioid products;
2 unchanged sentences
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.
−Removed: Our Portfolio
−Removed: Our mission is to build a leading, diversified specialty pharmaceutical company committed to improving the lives of people living with serious medical conditions.
−Removed: 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.
−Removed: 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.
−Removed: Xtampza ER is an abuse-deterrent, extended-release, oral formulation of oxycodone.
−Removed: 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).
−Removed: This technology combines an active opioid ingredient with a fatty acid and waxes to form microspheres that are filled into a capsule.
−Removed: These wax-based microspheres are designed to resist particle size reduction and dose dumping when subjected to physical and chemical manipulation.
−Removed: In April 2016, the 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.
−Removed: 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.
−Removed: In June 2016, we commercially launched Xtampza ER in the United States.
−Removed: 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).
−Removed: This technology combines an active opioid ingredient with a fatty acid and waxes to form microspheres that are filled into a capsule.
−Removed: These wax-based microspheres are designed to resist particle size reduction and dose dumping when subjected to physical and chemical manipulation.
−Removed: Xtampza ER’s label indicates a dosing regimen of one capsule every 12 hours, and it must be taken with food.
−Removed: 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 2023.
−Removed: 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.
−Removed: 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).
−Removed: 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;
−Removed: crushed OxyContin was bioequivalent to crushed oxycodone IR.
−Removed: 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.
−Removed: We are committed to ongoing monitoring and public dissemination of our real-world abuse and diversion data, regardless of the results.
−Removed: The two main sources of real-world abuse, misuse, and diversion data are RADARS® and Inflexxion, an IBH Company.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: Potential limitations are based upon the fact that the Poison Center and Treatment Center Program cases involve self-reporting which may lead to:
−Removed: 1) differential misidentification among drug groups which may affect observed differences, and 2) case counts of drug groups comprised primarily of branded products (other ADF ER opioids) may be overestimated when based on self-reporting and drug groups comprised primarily of generic products (non-ADF ER opioids and IR oxycodone) may be underestimated.
−Removed: The RADARS data represents a single snapshot in time and is subject to change.
−Removed: Therefore, we plan to continue monitoring real world data characterizing the rate of abuse, misuse, and diversion of Xtampza.
−Removed: Nucynta Products
−Removed: The Nucynta Products are oral formulations of tapentadol.
−Removed: Nucynta ER was approved by the FDA in November 2008 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.
−Removed: Nucynta IR was approved by the FDA in November 2008 for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults.
−Removed: We began commercializing the Nucynta Products in 2018 pursuant to a Commercialization Agreement (the “Nucynta Commercialization Agreement”) with Assertio Therapeutics, Inc.
−Removed: (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.
−Removed: 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”).
−Removed: Upon closing the Nucynta Acquisition, the Nucynta Commercialization Agreement and our prior royalty obligation to Assertio ceased;
−Removed: our only remaining royalty obligation is to pay 14% of net sales of the Nucynta Products directly to Grünenthal Gmbh under the Grünenthal License.
−Removed: Belbuca and Symproic
−Removed: Belbuca is a buccal film that contains buprenorphine, a partial opioid agonist, and was approved by the FDA in October 2015 for use in patients with pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative options are inadequate.
−Removed: Symproic is an oral formulation of naldemedine.
−Removed: Symproic was approved by the FDA in March 2017 for the treatment of 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.
−Removed: We began commercializing Belbuca and Symproic in March 2022 upon consummation of the BDSI Acquisition.
Manufacturing of Our Products
1 unchanged sentence
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.
−Removed: To date, we have produced Xtampza ER through a contract manufacturing organization, Patheon, a subsidiary of Thermo Fisher Scientific, Inc.
+Added: To date, we have produced Xtampza ER through a contract manufacturing organization, Patheon, a subsidiary of Thermo Fisher Scientific, pursuant to a third-party supply agreement.
Our microsphere production is currently conducted in a dedicated manufacturing suite as we transitioned the microsphere production to the new suite in 2021.
1 unchanged sentence
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 at an alternative location (and with an alternative vendor) if necessary.
−Removed: Nucynta ER was historically produced at a Janssen facility in Puerto Rico pursuant to a supply agreement that we assumed from Assertio in connection with the Nucynta Acquisition.
+Added: The Nucynta Products are manufactured pursuant to supply agreements with third-party manufacturers.
+Added: 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.
−Removed: Thus, Nuncynta ER is currently manufactured at Patheon, pursuant to a supply agreement.
−Removed: Nucynta IR is produced at a contract manufacturing organization, Cambrex, pursuant to a supply agreement.
−Removed: Belbuca and Symproic are manufactured pursuant to supply agreements we assumed from BDSI in connection with the BDSI Acquisition.
+Added: Nucynta ER is currently manufactured by Patheon.
+Added: Nucynta IR is manufactured by Halo Pharmaceutical, Inc.
+Added: in Whippany, New Jersey.
+Added: 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.
−Removed: Paul, Minnesota or Sharp Packaging Solutions in Allentown, Pennsylvania where it is converted into individual dosage units and, ultimately, into finished goods.
+Added: Paul, Minnesota or Sharp Packaging Solutions in
+Added: 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 by UPM Pharmaceuticals in Bristol, Tennessee and packaged by Sharp Packaging Solutions in Allentown, Pennsylvania.
−Removed: Prior to discontinuation of our commercialization activities, Elyxyb was manufactured and packaged by Contract Pharmaceuticals Limited Canada in Mississauga, Ontario.
Drug Substances
1 unchanged sentence
DEA Drug Schedule
−Removed: Buprenorphone
−Removed: Not a controlled substance
+Added: Buprenorphine
Not a controlled substance
1 unchanged sentence
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.
−Removed: is classified as a Schedule III controlled substance, meaning it has a moderate to low potential for abuse.
+Added: Belbuca is classified as a Schedule III controlled substance, meaning it has a moderate to low potential for abuse.
Due to the controlled substances classification, the manufacturing, shipping, dispensing and storing of these products are subject to a high degree of regulation, as described in more detail under the caption “— Government Regulation — DEA and Opioid Regulation.”
−Removed: We currently procure the API used in our products from a sole supplier or limited numbers of suppliers.
−Removed: As part of our business continuity program, we are in the process of qualifying additional API manufacturers.
+Added: We currently procure the API used in our products from a sole supplier or limited number of suppliers.
Marketing and Commercialization
5 unchanged sentences
Customers in the managed health care market include health maintenance organizations, nursing homes, hospitals, clinics, pharmacy benefit management companies and mail order customers.
−Removed: Three of our customers comprised more than 10% of our revenue during the year ended December 31, 2022.
−Removed: These customers comprised 33%, 33% and 31% of revenue, respectively.
−Removed: As the COVID-19 pandemic unfolded, and governmental and societal reactions to it evolved, our business was impacted by several trends, including depressed pain patient office visits compared to pre-COVID periods, which in turn may account for fewer patients beginning therapy with our products, and labor disruptions that impacted pain offices, which in turn impacted our access to, and quality of interactions with, such offices.
−Removed: Notwithstanding the fact that the Department of Health and Human Services is planning for the federal public health emergency for COVID-19 to expire in May 2023, we expect the trends that emerged as a result of the pandemic to persist in the near to medium term.
Intellectual Property
The protection of patents, designs, trademarks and other proprietary rights that we own or license is critical to our success and competitive position.
−Removed: 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.
−Removed: 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.
+Added: Xtampza ER is protected by twelve 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.
+Added: Finally, we have six patent applications pending in the United States, one pending patent application in each of Canada and Japan, and one pending Patent Cooperation Treaty (“PCT”) application.
Our issued U.S.
1 unchanged sentence
In addition, we use a unique and proprietary process to manufacture our products that requires significant know how, which we currently protect as trade secrets.
−Removed: Nucynta 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.
−Removed: Nucynta ER is protected by seven 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 2023, 2024, 2025, and 2028.
+Added: 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.
+Added: Nucynta IR is also covered by New Patient Population exclusivity in
+Added: pediatric patients that is projected to expire in 2026.
+Added: 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.
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.
1 unchanged sentence
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.
−Removed: 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.
+Added: 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.
6 unchanged sentences
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.
−Removed: However, our primary source of competition stems from the generic opioid market, including both extended-release and immediate-release opioid drugs.
+Added: However, our primary source of competition stems from the generic opioid market, including both long-acting/extended-release and immediate-release opioid drugs.
Most of the existing and potential competitors have significantly more financial and other resources than we do.
9 unchanged sentences
● completion of preclinical laboratory and animal testing and formulation studies in compliance with the FDA’s good laboratory practices (“GLP”) and regulations;
−Removed: ● submission to the FDA of an Investigational New Drug Application (“IND”) for human clinical testing, which becomes effective 30 days after submission and, if not placed on clinical hold, before human clinical trials may begin in the United States;
+Added: ● submission to the FDA of an Investigational New Drug (“IND”) application for human clinical testing, which becomes effective 30 days after submission and, if not placed on clinical hold, before human clinical trials may begin in the United States;
● approval by an independent institutional review board, at each clinical trial site before each trial may be initiated;
7 unchanged sentences
The conduct of the preclinical tests must comply with federal regulations and requirements, including GLPs.
−Removed: 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.
−Removed: Long-term preclinical tests, such as animal tests of reproductive toxicity and carcinogenicity, may continue after the IND is submitted.
+Added: The results of preclinical testing are submitted to the FDA as part of an IND application along with other information, including information about product chemistry, manufacturing and controls, and a proposed clinical trial protocol.
+Added: Long-term preclinical tests, such as animal tests of reproductive toxicity and carcinogenicity, may continue after the IND application is submitted.
Clinical trials involve the administration of the investigational new drug to healthy volunteers or subjects under the supervision of a qualified investigator.
24 unchanged sentences
Moreover, even if the applicant believes it has addressed the deficiencies, it is possible that approval may not ultimately be obtained.
−Removed: Where a sponsor wishes to expand the originally approved prescribing information, such as by adding a new indication, it must submit and obtain approval of a supplemental NDA (“sNDA”).
+Added: Where a sponsor wishes to expand the originally approved prescribing information, such as by adding a new indication, it must submit and obtain approval of a sNDA.
Changes to an indication generally require additional clinical studies, which can be time-consuming and require the expenditure of substantial additional resources.
11 unchanged sentences
The goal of the Opioid Analgesic REMS is to educate prescribers and other healthcare providers (including pharmacists and nurses) on the treatment and monitoring of patients with pain.
−Removed: Manufacturers subject to this class-wide REMS must work together to implement the REMS as part of the Opioid Analgesic REMS Program Companies ("RPC"), which is a collaboration of drug product companies to implement a single shared REMS to reduce the burden on the healthcare system accessed from the RPC REMs website.
+Added: Manufacturers subject to this class-wide REMS must work together to implement the REMS as part of the Opioid Analgesic REMS Program Companies ("RPC"), which is a collaboration of drug product companies to implement a single shared REMS to reduce the burden on the healthcare system accessed from the RPC REMs website.
The content on this website is determined by, hosted on behalf of, and is financially supported by the RPC.
1 unchanged sentence
Specifically, the REMS includes a product-specific Medication Guide and the Patient Counseling Guide available for distribution to patients who are dispensed the drug, as well as a number of ETASU.
−Removed: These ETASU include REMS-compliant accredited CE for Healthcare Providers (HCPs), which includes all healthcare providers who prescribe or are involved in the management of patients with pain;
−Removed: information provided to prescribers that they can use to educate patients in the safe use, storage, and disposal of opioids;
+Added: 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;
+Added: information provided to prescribers that they can use
+Added: 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.
3 unchanged sentences
For the first time, FDA notified companies that have NDAs or ANDAs for certain opioid analgesic drug products (“NDA/ANDA holders”) of the elements required for a single REMS for opioid analgesic products, whether branded or generic.
−Removed: The REMS requires that training be made available to health care providers who
−Removed: 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.
+Added: 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.
10 unchanged sentences
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.
+Added: 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.
+Added: The DSCSA mandates phased-in and resource-intensive obligations for pharmaceutical manufacturers, wholesale distributors, and dispensers that culminated in November 2023.
+Added: 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.
+Added: 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.
Adverse event reporting and submission of periodic reports is required following FDA approval of an NDA.
4 unchanged sentences
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.
−Removed: The FDA may require post-approval studies and clinical trials if the FDA finds that scientific data, including information regarding related drugs, warrant them.
−Removed: 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 such a risk.
+Added: The FDA may require post-approval studies, including post-marketing surveillance and observational studies and clinical trials, if the FDA finds that scientific data, including information regarding related drugs, warrant them.
+Added: The purpose of such studies would be to collect additional information to assess a known serious risk or signals of serious risk related to the drug or to monitor for or identify an unexpected serious risk when available data indicate the potential for such a risk.
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.
−Removed: The FDA recently announced a meeting of the Anesthetic and Analgesic Drug Products Advisory Committee to be held on April 19, 2023.
−Removed: The committee will discuss post-marketing requirements 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.
−Removed: The discussion will focus on a clinical trial designed to address these objectives.
−Removed: We intend to participate in this meeting.
+Added: Discovery of previously unknown problems with a drug or the failure to comply with applicable FDA requirements can have negative consequences, including adverse publicity, judicial or administrative enforcement, untitled or warning letters from the FDA, mandated corrective advertising or communications with doctors, and civil or criminal penalties, among others.
+Added: The FDA held a meeting of the Anesthetic and Analgesic Drug Products Advisory Committee on April 19, 2023.
+Added: 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.
+Added: The discussion focused on a clinical trial designed to address these objectives.
+Added: 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.
+Added: As part of the Opioid PMR Consortium, Collegium is working with the FDA to redesign study 3033-11.
The Hatch-Waxman Amendments
1 unchanged sentence
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.
−Removed: 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
+Added: 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.
Drugs listed in the Orange Book can, in turn, be cited by potential generic competitors as referenced listed drugs (“RLDs”) in support of approval of an ANDA.
14 unchanged sentences
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.
−Removed: 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.
+Added: 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,
+Added: 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.
10 unchanged sentences
until any non-patent exclusivity listed in the Orange Book for the referenced product has expired;
−Removed: and, in the case of a Paragraph IV
−Removed: 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.
+Added: 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.
In the interim period, the FDA may grant tentative approval.
19 unchanged sentences
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.
−Removed: 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 annually to the DEA for individual production and procurement quotas.
+Added: 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.
−Removed: Our contract manufacturers must receive an annual 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.
+Added: 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.
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.
−Removed: As a result of a projected decrease in need for Schedule II opioids in 2023 and in an attempt to further reduce the risk of diversion, the DEA is lowering the supply of Schedule II opioids, which includes an average decrease in oxycodone and tapentadol, of approximately 6%.
Distributions of any Schedule I or II controlled substance must also be accompanied by special order forms, with copies provided to the DEA.
2 unchanged sentences
To enforce these requirements, the DEA conducts periodic inspections of registered establishments that handle controlled substances.
−Removed: Failure to maintain compliance with applicable requirements, particularly as manifested in loss or
−Removed: diversion, can result in administrative, civil, or criminal enforcement action that could have a material adverse effect on our business, results of operations and financial condition.
+Added: Failure to maintain compliance with applicable requirements, particularly as manifested in loss or diversion, can result in administrative, civil, or criminal enforcement action that could have a material adverse effect on our business, results of operations and financial condition.
The DEA may seek civil penalties, refuse to renew necessary registrations, or initiate administrative proceedings to revoke those registrations.
5 unchanged sentences
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.
−Removed: 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.
+Added: 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 the Centers for Medicare and Medicaid Services (“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.
4 unchanged sentences
Some states, however, have applicable fraud and abuse laws that apply more broadly to include products or services reimbursed by private payors.
−Removed: The federal Anti-Kickback Statute (42 U.S.C.
+Added: The federal Anti-Kickback Statute (“AKS”) (42 U.S.C.
§ 1320a-7b(b)) prohibits knowingly and willfully soliciting, receiving, offering or providing remuneration, directly or indirectly, to induce either the referral of an individual, or the furnishing, recommending, or arranging for a good or service, for which payment may be made under a federal healthcare program such as the Medicare and Medicaid programs.
−Removed: 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.
+Added: 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,
+Added: 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.
7 unchanged sentences
The Criminal Healthcare Fraud statute, 18 U.S.C.
−Removed: § 1347 prohibits knowingly and willfully executing a scheme to defraud any healthcare benefit program, including private third-party payers.
+Added: § 1347 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.
2 unchanged sentences
The qui tam provisions of the False Claims Act and similar state laws allow a private individual to bring civil actions on behalf of the federal or state government and to share in any monetary recovery.
−Removed: The Federal Physician Payments
−Removed: Sunshine Act and similar state laws impose reporting requirements for various types of payments to physicians, other licensed healthcare practicioners and teaching hospitals.
+Added: The Federal Physician Payments Sunshine Act and similar state laws impose reporting requirements for various types of payments to physicians, other licensed healthcare practitioners and teaching hospitals.
Failure to comply with required reporting requirements under these laws could subject manufacturers and others to substantial civil monetary 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.
+Added: The federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) created additional federal criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payor (e.g., public or private) and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false statements in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters.
+Added: Like the AKS, the Patient Protection and Affordable Care Act (the “ACA”) amended the intent standard for certain healthcare fraud statutes under HIPAA such that a person or entity no longer needs to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation.
+Added: HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (“HITECH”) and their respective implementing regulations, also impose requirements on certain covered healthcare providers, health plans, and healthcare clearinghouses as well as their respective business associates that perform services for them that involve the creation, use, receipt, maintenance or disclosure of individually identifiable health information, relating to the privacy, security and transmission of individually identifiable health information.
+Added: 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.
+Added: 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
+Added: practitioners, and to teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members.
+Added: 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.
+Added: In addition, federal consumer protection and unfair competition laws broadly regulate marketplace activities and activities that potentially harm consumers.
+Added: 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;
+Added: 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;
+Added: 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;
+Added: state and local laws requiring the registration of pharmaceutical sales representatives;
+Added: and state and foreign laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.
+Added: Because of the breadth of these laws and the narrowness of the statutory exceptions and regulatory safe harbors available, it is possible that some of a pharmaceutical manufacturer’s business activities could be subject to challenge under one or more of such laws.
+Added: Efforts to ensure that business arrangements comply with applicable healthcare laws involve substantial costs.
+Added: It is possible that governmental and enforcement authorities will conclude that a pharmaceutical manufacturer’s business practices do not comply with current or future statutes, regulations or case law interpreting applicable fraud and abuse or other healthcare laws and regulations.
+Added: If any such actions are instituted against a pharmaceutical manufacturer, and it is not successful in defending itself or asserting its rights, those actions could have a significant impact on its business, including the imposition of significant civil, criminal and administrative penalties, damages, disgorgement, imprisonment, monetary fines, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, reporting obligations and oversight if we become subject to integrity and oversight agreements to resolve allegations of non-compliance, contractual damages, reputational harm, diminished profits and future earnings, and curtailment of operations, any of which could adversely affect a pharmaceutical manufacturer’s ability to operate its business and the results of operations.
+Added: In addition, commercialization of any drug product outside the U.S.
+Added: will also likely be subject to foreign equivalents of the healthcare laws mentioned above, among other foreign laws.
Third-Party Payor Coverage and Reimbursement
25 unchanged sentences
Among the provisions of the Affordable Care Act of importance to the pharmaceutical and biotechnology industry are the following:
−Removed: ● an annual, nondeductible 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;
+Added: ● an annual, non-deductible fee on any entity that manufactures or imports certain branded prescription drugs and biologic agents, apportioned among these entities according to their market share in certain government healthcare programs;
● an increase in the rebates a manufacturer must pay under the Medicaid Drug Rebate Program to 23.1% and 13% of the average manufacturer price for branded and generic drugs, respectively;
8 unchanged sentences
The Affordable Care Act has been subject to challenges in the courts.
−Removed: On June 17, 2021, in an appeal from a lower court decision holding that the individual mandate under the Affordable Care Act is unconsistutional, 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.
+Added: 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.
In addition, other legislative changes have been proposed and adopted since the Affordable Care Act was enacted.
−Removed: The Budget Control Act of 2011 and subsequent legislation has resulted in reductions to Medicare payments to providers of up to 2% per fiscal year, which will remain in effect through 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, 2022.
−Removed: From April through June 2022, a 1% reduction was in effect.
−Removed: As of July 2, 2022, the 2% cut resumed.
+Added: The Budget Control Act of 2011 and subsequent legislation has resulted in reductions to Medicare payments to providers of up to 2% per fiscal year, which will remain in effect through 2030 unless additional action is taken by Congress.
The American Taxpayer Relief Act of 2012 reduced Medicare payments to several providers and increased the statute of limitations period for the government to recover overpayments to providers from three to five years.
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.
−Removed: In December 2017, the Tax Cuts and Jobs Act (“TCJA”) repealed the shared responsibility payment for individuals who fail to maintain minimum essential coverage under section 5000A of the Internal Revenue Code, commonly referred to as the individual mandate, beginning in 2019.
−Removed: The Joint Committee on Taxation estimates that the repeal will result in over 13 million Americans losing their health insurance coverage over the next ten years, and is likely to lead to increases in insurance premiums.
−Removed: It is uncertain how or whether this legislation may affect our customers and, accordingly, our financial operations.
−Removed: In August 2022, the Inflation Reduction Act of 2022 was signed into law.
−Removed: This legislation contains substantial drug pricing reforms, including the establishment of a drug price negotiation program within the U.S.
−Removed: Department of Health and Human Services that would require manufacturers to charge a negotiated “maximum fair price” for certain selected drugs or pay an excise tax for noncompliance, the establishment of rebate payment requirements on manufacturers of certain drugs payable under Medicare Parts B and D to penalize price increases that outpace inflation, and requires manufacturers to provide discounts on Part D drugs.
−Removed: The Inflation Reduction Act of 2022 also caps Medicare
−Removed: beneficiaries’ annual out-of-pocket drug expenses.
−Removed: Substantial penalties can be assessed for noncompliance with the drug pricing provisions in the Inflation Reduction Act of 2022.
−Removed: The Inflation Reduction Act of 2022 could have the effect of reducing the prices we can charge and reimbursement we receive for our products, thereby reducing our profitability, and could have a material adverse effect on our financial condition, results of operations and growth prospects.
−Removed: The effect of the Inflation Reduction Act of 2022 on our business and the pharmaceutical industry in general is not yet known.
−Removed: Other Regulatory Requirements
−Removed: We are also subject to various laws and regulations regarding laboratory practices, the experimental use of animals, and the use and disposal of hazardous or potentially hazardous substances in connection with our research.
−Removed: 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.
+Added: 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.
+Added: Removal of the drug rebate cap can result in paying rebate payments to Medicaid that are higher than the sale price of the drug.
+Added: 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.
+Added: Department of Health and Human Services that would require manufacturers to charge a negotiated “maximum fair price” for certain selected drugs or pay an excise tax for noncompliance.
+Added: Another component of the IRA includes the establishment of rebate payment requirements on Medicare Part D drugs which penalize price increases that outpace inflation.
+Added: The IRA also redesigned Medicare Part D to reallocate cost across the various stakeholders:
+Added: CMS, payors, manufacturers, and beneficiaries.
+Added: Certain aspects of the Part D redesign take effect in 2024 which ultimately shifts some liability from beneficiaries to the payors.
+Added: Starting in 2025, all remaining components of the Part D Redesign will take effect.
+Added: Ultimately, the existing coverage gap will be removed and replaced with greater exposure for manufacturers after the beneficiary pays their deductible.
+Added: Additionally, the exemption previously applied on the low-income subsidy (“LIS”) population has been removed and increases manufacturer rebate exposure for that population.
+Added: 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.
+Added: The implementation of the IRA is currently subject to ongoing litigation that challenges the constitutionality of the IRA’s Medicare drug price negotiation program.
+Added: The IRA could have the effect of reducing the prices we can charge and reimbursement we receive for our products, thereby reducing our profitability, and could have a material adverse effect on our financial condition, results of operations and growth prospects.
+Added: The effect of the IRA on our business and the pharmaceutical industry in general is not yet known.
Our Environmental, Social, and Governance (“ESG”) Initiatives
−Removed: Our commitment to serving as a responsible corporate citizen, through the advancement of our mission, expansion of our product portfolio, intentional business decisions and dedication to corporate social responsibility (CSR) activities, is longstanding.
−Removed: We have focused on implementing corporate governance and risk-mitigation best practices, investing in the development of our culture and people, engaging with our broader communities in meaningful ways and introducing operational efficiencies to reduce our environmental impact.
+Added: Our commitment to serving as a responsible corporate citizen is rooted in our longstanding history of advancing our mission, executing our commercial strategy, governing our business to drive efficiency and value creation, and supporting our communities.
+Added: We have prioritized corporate governance and risk mitigation;
+Added: employee development and culture;
+Added: our environmental footprint;
+Added: and giving back to our communities.
As a reflection of this commitment, our annual Corporate Scorecard has included metrics relating to our performance relative to specific ESG initiatives.
−Removed: In February 2023, we published our inaugural ESG report on our corporate website highlighting our ESG accomplishments to date and focus on advancing the oversight, evolution, and reporting of our ESG program.
−Removed: The information contained in our ESG report is not a part of, nor is it incorporated by reference in, this Form 10-K.
−Removed: Collegium Culture, Employee Engagement and Management of Human Capital Resources
+Added: In February 2024, we published our annual ESG report on our corporate website highlighting our ESG accomplishments to date.
+Added: The information contained in our ESG report is not a part of, nor is it incorporated by reference into, this Form 10-K.
+Added: Human Capital Management
+Added: Collegium Culture and Employee Engagement
Our employees are foundational to our current and future success, and we believe that their engagement and commitment are among our most valuable assets.
−Removed: As we seek to build and sustain a challenging, inspiring, and inclusive environment for our employees, we have focused on safety and wellness;
−Removed: talent acquisition and retention;
−Removed: employee engagement, development, and training;
+Added: As we seek to build and sustain a challenging, inspiring, and inclusive environment for our employees, we have focused on talent acquisition and retention;
+Added: employee training and development;
diversity and inclusion;
−Removed: and compensation and pay equity.
+Added: and employee health and safety.
At Collegium, we recognize that we have a responsibility to hold ourselves to the highest standard of business and professional ethics.
2 unchanged sentences
Uphold Integrity, Embrace Differences, Encourage Expression, and Be Accountable.
−Removed: As one reflection of our Core Values, we are dedicated to being a responsible corporate citizen.
−Removed: We and our employees strive to make a positive impact in the communities where we live and work by fostering a culture of philanthropy, service, and mentorship, supporting the wellness of our communities, and working for equitable access to education and educational resources.
−Removed: In addition, we have a charitable matching gift program, which enables employees to make matched charitable donations to any registered 501(c)(3) charity.
−Removed: We have also established a service initiative, which includes financial donations supporting local and national nonprofits with a focus on STEM initiatives and community service.
−Removed: In 2022, we donated over $350,000 and approximately 180 hours of service in support of these charitable initiatives.
−Removed: Employee Health and Safety
−Removed: We believe that the success of our business is fundamentally connected to the well-being of our employees;
−Removed: accordingly, we are committed to their health, safety, and wellness.
−Removed: We provide all employees and their families with access to a variety of innovative, flexible and convenient health and wellness programs.
−Removed: These programs include 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;
−Removed: 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;
−Removed: and that offer choice, where possible, so they can customize their benefits to meet their needs and the needs of their families.
−Removed: Employee Engagement
−Removed: None of our employees are represented by a labor organization or under any collective bargaining arrangements.
−Removed: We consider our employee relations to be good.
−Removed: We were named a 2022 National Top Place to Work for the second consecutive year following recognition in the Boston Globe’s Top Places to Work Massachusetts in 2021 and the Boston Business Journal’s Best Places to Work in 2020.
−Removed: These recognitions are based on anonymous employee surveys, and we believe these recognitions reflect our mission, Core Values and dedication to employees’ well-being.
+Added: We prioritize transparency, recognition, and collaboration to support our team’s engagement.
+Added: We facilitate transparent communications through various channels, such as quarterly all-employee meetings, small-group employee conversations with our Chief Executive Officer, and periodic employee engagement surveys.
Talent Acquisition and Retention
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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.
−Removed: We offer a comprehensive and competitive benefit package to all full-time employees including medical, dental and vision benefits;
−Removed: flexible spending account;
−Removed: life and disability insurance;
−Removed: paid parental and caregiver leave;
−Removed: a 401(k) with a dollar-for-dollar matching contribution on the first 5% contributed by the employee;
−Removed: an employee stock purchase plan;
−Removed: a hybrid workweek that allows most employees to work from home up to two days each week;
−Removed: charitable matching up to $1,000 per employee per calendar year for donations to registered 501(c)(3) charities;
−Removed: tutoring for employees’children;
−Removed: a company-wide shut down during the last week of the year;
−Removed: complementary access to the gym in our headquarters and a fully stocked snack and drink room available to employees at our headquarters.
−Removed: In addition, through our Collegium Cares Program, employees can award points to colleagues for demonstrating our Core Values and Leadership Behaviors, which can be exchanged for rewards.
−Removed: In 2022, we had 90 new hires and, as of December 2022, our voluntary turnover rate was 28.3% in the home office and 38.8% in the field.
Employee Training and Development
−Removed: We believe that career development begins with good conversations between employees and their managers that ensure regular feedback, and we have implemented tools and annual processes that allow all employees in conjunction with their managers to explore possibilities and drive development action.
−Removed: All employees work with their managers to create annual Individual Development Plans with specific objectives and resource actions.
−Removed: We encourage our employees to develop breadth and depth of experience, build transferable skills, broaden perspectives and hone technical skill sets.
−Removed: While career promotion is driven by business needs and sustained strong performance and capabilities, we have identified and articulated Leadership Behaviors that drive career development within the organization, and our people managers provide feedback to all employees that is tied to demonstration of these skills.
−Removed: Our comprehensive performance review process ensures our employees are on track with their development throughout the year and provides an opportunity for managers to identify talented individuals for our Emerging Leaders Program.
−Removed: This is an annual initiative comprising specialized assessments and training to prepare employees for management and leadership positions throughout the business and reaffirms our commitment to excellence in our industry.
+Added: We believe career development begins with good conversations between employees and their managers that ensure regular feedback, and we have implemented tools and annual processes that allow all employees in conjunction with their managers to explore possibilities and drive development action.
+Added: Our comprehensive performance review process ensures our employees are on track with their development throughout the year.
Diversity, Equity, and Inclusion
3 unchanged sentences
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.
−Removed: Consistent with this commitment, we established our DEI Council comprised of a cross-functional team of employees and executives in June 2020.
−Removed: The DEI Council focuses on shaping and implementing our DEI strategy and routinely reviews our recruitment and hiring practices, with the intention of improving diversity at all levels within our organization.
−Removed: Additionally, we are implementing a multi-year DEI strategic plan that strives to integrate DEI with our
−Removed: overall business goals by focusing on topics such as developing, retaining, and attracting talent;
+Added: 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;
9 unchanged sentences
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.
−Removed: Environmental Impact
−Removed: We recognize that our duty of care extends beyond people to the planet we all share.
−Removed: We are taking action to minimize our environmental impact through several initiatives, such as implementing in-office processes to minimize the use of consumables, investing in clean-in-place manufacturing systems, and exploring options to reduce the impact of our sales fleet, to name a few.
−Removed: Moreover, we continue to review and update our vendor performance management and other operational policies as part of our commitment to environmental sustainability.
−Removed: This practice enables us to minimize resource use and waste generation, optimize the use of raw materials and undertake continuous improvement in environmental performance, with an emphasis on recycling packaging materials and implementing sustainability opportunities in our vendor supply chains.
−Removed: We are developing an action plan to ensure we are actively monitoring our use of resources throughout the value chain.
−Removed: We are working to review and understand the financial implications of our environmental risks, setting baselines and tracking resources with a focus on reducing our impacts, while maintaining transparency about future climate risks and the material impacts on our company.
−Removed: We conduct our operations in compliance with applicable laws, directives, and regulations.
−Removed: Our current material handling policies and management systems include procedures for assessing compliance with applicable laws and regulations and reporting incidents of non-compliance to applicable governmental authorities.
+Added: Employee Health and Safety
+Added: We believe that the success of our business is fundamentally connected to the well-being of our employees;
+Added: accordingly, we are committed to their health, safety, and wellness.
+Added: We provide all employees and their families with access to a variety of innovative, flexible, and convenient health and wellness programs.
Our Executive Officers
51 unchanged sentences
Director of Strategic Planning and Director of Cardiovascular Marketing.
−Removed: Dreyer received his B.S.
+Added: Dreyer received a B.S.
in Biology from Messiah College.
2 unchanged sentences
Prior to joining Collegium, Ms.
−Removed: Kuhlmann was an attorney in the Health Sciences Group of Pepper Hamilton LLP, a law firm headquartered in Philadelphia, PA.
+Added: Kuhlmann was an attorney in the Health Sciences Group of Pepper Hamilton LLP, a law firm headquartered in Philadelphia, Pennsylvania.
Kuhlmann began her career at Pepper Hamilton in 2007 as an Associate and was elected a Partner of the firm in 2016.
16 unchanged sentences
and in October 2003, our predecessor changed its name to Collegium Pharmaceutical, Inc.
−Removed: In July 2014, we reincorporated in
−Removed: the Commonwealth of Virginia pursuant to a merger whereby Collegium Pharmaceutical, Inc., a Delaware corporation, merged with and into Collegium Pharmaceutical, Inc., a Virginia corporation, with the Virginia corporation surviving the merger.
+Added: In July 2014, we reincorporated in the Commonwealth of Virginia pursuant to a merger whereby Collegium Pharmaceutical, Inc., a Delaware corporation, merged with and into Collegium Pharmaceutical, Inc., a Virginia corporation, with the Virginia corporation surviving the merger.
Available Information
5 unchanged sentences
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.