What changed in this filing

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Item 1. Business

2022-02-24 compared with 2021-02-25 · 163 added, 97 removed, 461 unchanged (36% of the section changed)

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

We are building a leading, diversified specialty pharmaceutical company committed to improving the lives of people living with serious medical conditions.

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.

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For the fiscal year ended December 31, 2021, we generated $276.9 million in net revenues, comprised of $103.7 million from sales of Xtampza ER and $173.2 million from sales of the Nucynta Products.

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).

As of the date of the filing of this Annual Report on Form 10-K, we expect the COVID-19 pandemic and actions taken to contain it to continue to impact our revenue.

Notwithstanding the lifting of some COVID-19 restrictions in many jurisdictions, and amidst continuing public health concerns relating to the spread of COVID-19, particularly variants thereof, weekly pain patient office visits continue to be depressed compared to pre-COVID periods, which we believe in turn may account for fewer patients beginning therapy with our products.

We believe that the disruptions caused by COVID-19 will continue and there remains substantial uncertainty as to when such disruptions will cease.

Pain, Pain Management and Opioid Abuse in the United States

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Prescription opioids continue to serve as important tools in the treatment of acute and chronic pain where alternative treatments have been inadequate.

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.

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.

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 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

In 2021, there were approximately 152.8 million prescriptions for opioids written in the United States, representing a 3% decline from 2020 levels and including approximately 2.9 million prescriptions for branded extended-release opioids, approximately 12.1 million prescriptions for generic extended-release opioids, and greater than 137.7 million prescriptions for immediate-release opioids.

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

Prescription levels for 2020 represented 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.

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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.

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

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

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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 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.

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.

Provisional data from the National Center for Health Statistics at the Centers for Disease Control and Prevention (based on data available as of February 6, 2022) indicate that there were at least 74,754 opioid overdose deaths for the 12‐month period ending September 2021, a year‐over-year increase of approximately 22%.

While the bulk of these deaths is attributable to synthetic opioids (excluding methadone), there remain a substantial number of overdose deaths attributable to natural and semi‐ synthetic opioids, with rates that have remained essentially consistent since at least 2015.

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

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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.

In 2019, an estimated 10.1 million, or 3.7% of persons aged 12 and older, reported opioid misuse in the prior year as collected by the National Survey on Drug Use and Health sponsored by Substance Abuse and Mental Health Services Administration (SAMHSA).

There was no significant change in this data for 2020.

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.

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.

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The Collegium Portfolio

Our mission is to be the leader in responsible pain management.

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

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

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gross sales and approximately 1.5 million prescriptions written in 2021.

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.

Relative to 2020, dollars generated by sales for OxyContin and its authorized generic forms written in the United States in 2021

declined 19%, with a 20% decline prescription volume.

In 2021, approximately 681,000 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.

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

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

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

We are committed to ongoing monitoring and public dissemination of our real-world abuse and diversion data, regardless of the results.

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

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

Abuse, misuse, and diversion of Xtampza ER has remained low compared to commonly abused schedule II opioid analgesics for three years after introduction into the U.S.

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

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

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.

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

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

We believe Xtampza ER is well-positioned to capture a significant share of extended-release oxycodone market.

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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 and a variable royalty of 14% on net sales for ultimate payment to Grünenthal Gmbh.

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.

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, through the assumption of a license from Grünenthal Gmbh (the “Grünenthal License”).

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.

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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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 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.

Our microsphere production is currently conducted in a dedicated manufacturing suite as we transitioned the microsphere production to the new suite in 2021.

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 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 in Cincinnati, Ohio;

we have assumed responsibility for completing such technology transfer 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.

Collegium continues to execute the transfer of the Nucynta ER manufacturing process through a technology transfer program to enable manufacturing of Nucynta ER at Patheon in Cincinnati, Ohio.

Collegium expects the Nucynta ER process to be completed in 2022.

Nucynta IR is produced at a contract manufacturing organization, Cambrex, pursuant to a supply agreement.

Drug Substances

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.

- based manufacturer.

We are aware of other suppliers who we would expect to be able to satisfy our commercial orders.

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

As part of our business continuity program, we are in the process of qualifying a secondary active pharmaceutical ingredient manufacturer.

The active pharmaceutical ingredient used in the Nucynta Products is tapentadol, which is supplied by a single U.S.-based manufacturer.

As part of our business continuity program, we are in the process of qualifying a secondary active pharmaceutical ingredient manufacturer.

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

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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 94 sales representatives and managers, to call on the approximately 10,000 health care professionals who write approximately 62% 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 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.

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

Three of our customers comprised 10% or more of our revenue during the year ended December 31, 2020.

Three of our customers comprised more

than 10% of our revenue during the year ended December 31, 2021.

These customers comprised 35%, 31% and 29% of revenue, respectively.

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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 .

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.

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

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Preclinical tests include laboratory evaluation of product chemistry, formulation, stability and toxicity, as well as animal studies to assess the characteristics and potential safety and efficacy of the product.

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 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.

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

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If the FDA’s evaluations of the NDA and of the sponsor’s manufacturing facilities are favorable, the FDA will issue an approval letter, and the sponsor may begin marketing the drug for the approved indications, subject to any post-approval requirements, described further below.

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.

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.

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

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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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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.

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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.

The DEA may seek civil penalties, refuse to renew necessary

registrations or initiate administrative proceedings to revoke those registrations.

In certain circumstances, violations could result in criminal proceedings.

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The Federal Physician Payments Sunshine Act and similar state laws impose reporting requirements for various types of payments to physicians and teaching hospitals.

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.

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.

Third-Party Payor Coverage and Reimbursement

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

A ruling is expected in 2021.

On June 17, 2021, 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 ACA or any of its provisions.

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

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.

An Act to Prevent Across-the-Board Direct Spending Cuts, and for Other Purposes, signed into law on April 14, 2021, extended the suspension period to December 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.

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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;

Environmental and Social Issues

Environmental, social, and governance (“ESG “) is fundamental to our strategy, purpose and culture.

We retained a third-party consultant (NASDAQ) to review our ESG strategy and disclosures, with ultimate oversight maintained by our Board of Directors and operationalized by our Nominating and Corporate Governance committee.

We are currently surveying all company departments with responsibility for activities that impact our ESG profile, including Commercial Operations, Supply Chain Management, Research and Development, Clinical Operations, Human Resources and Legal, among others.

We are also committed to aligning our practices with stakeholder expectations and third-party frameworks including the Sustainability Accounting Standards Board (SASB) Biotechnology & Pharmaceuticals standard, which affirms our commitments to the safety of clinical trial participants, drug safety and other priorities important to our stakeholders.

In 2021, we began refreshing our environmental risk management policies through setting baselines and tracking resources with a focus on reducing environmental impacts while exploring appropriate disclosures about future climate risks and the material impacts on our company.

We conduct our operations in compliance with applicable laws, directives and regulations.

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.

Moreover, we are reviewing and updating our vendor performance management policies governing our manufacturing vendors, as part of our commitment to environmental sustainability, in order to minimize resource use (e.g., energy and water) and waste generation, optimize the use of raw materials, and undertake continuous improvement in environmental performance, with an emphasis on recycling of packaging materials and working with sustainability opportunities in our vendor supply chains.

Collegium Culture, Employee Engagement and Management of Human Capital Resources

As of February 15, 2022, we had a total of 152 employees (all full-time), 64 of whom are home office-based and 88 of whom are field-based.

Our employees are foundational to our current and future success, and we believe that their engagement and commitment are among our most valuable assets.

As we seek to build and sustain a challenging, inspiring, and inclusive environment for our employees, we have focused on safety and wellness;

talent acquisition and retention;

employee engagement,

development, and training;

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.

At Collegium, we recognize that we have a responsibility to hold ourselves to the highest standard of business and professional ethics.

Our Core Values are the foundational principles of our organization and guide our work, how we interact with each other and our communities and influence the business strategies we employ to fulfill our mission.

Our Core Values are:

maintain uncompromising Integrity in everything we say and do;

embrace the Differences among us to make our ideas richer and better serve our communities;

encourage Expression to push ourselves to think big and make our voices heard;

and be Accountable to each other, our customers and our communities.

As one reflection of our Core Values, Collegium is dedicated to being a responsible corporate citizen.

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.

In addition, Collegium has a charitable matching gift program, which enables employees to make matched charitable donations to any registered 501(c)(3) charity.

Collegium has also established a service initiative, which includes financial donations supporting local and national nonprofits with a focus on STEM initiatives and community service.

In 2021, Collegium donated over $140,000 and over 400 hours of service in support of these charitable initiatives.

Employee Health & Safety

We believe that 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;

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

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;

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;

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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.

From March 2020 through August 2021, we modified our remote work policies to enable our employees to work from home wherever possible, and for employees who could not, or chose not to, work from home, we implemented safety measures to help prevent the spread of COVID-19 in the workplace, such as mandatory face coverings, social distancing, hand hygiene, and limited face-to-face meetings.

Since August 2021, when all office-based employees returned to the office on a hybrid workweek basis, both office-based and field-based employees (except in very limited circumstances) have been required to be fully vaccinated against COVID-19.

Employee Engagement

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

We consider our employee relations to be good.

In December 2021, Collegium was recognized by the Boston Globe as a 2021 Massachusetts Top Place to Work.

In February 2022, Collegium was recognized as a 2022 National Top Place to Work (for the second year in a row).

This award is based on an anonymous employee survey concerning engagement, leadership, connection, company values, benefits, and other topics.

These surveys are conducted annually;

in 2021, the recognition was based on participation and feedback from 78.3% of our workforce.

We believe these recognitions reflect our dedication to our four Core Values.

Talent Acquisition & Retention

We seek to identify, recruit, retain, incentivize, and integrate our existing and new employees, advisors and consultants.

All full-time employees receive stock-based and cash-based compensation awards through the compensation cycle;

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

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

Collegium offers a comprehensive and competitive benefit package to all full-time employees that includes medical, dental and vision benefits;

flexible spending account;

life and disability insurance;

paid parental and caregiver leave;

a 401(k) with a dollar-for-dollar matching contribution on the first 5% contributed by the employee;

an employee stock purchase plan;

a hybrid workweek that allows most employees to work from home up to two days each week, and charitable matching up to $1,000 per employee per calendar year for donations to registered 501(c)(3) charity.

In addition, we sponsor an employee recognition program that allows Collegium employees to reward their co-workers who have exhibited one of the Company's Core Values and/or Leadership Behaviors by awarding them points that can be redeemed for gift cards or merchandise.

In 2021, we had 32 new hires and, as of February 15, 2022, our voluntary turnover rate was 9.4% in the home office and 3.3% in the field.

Employee Training & Development

Collegium believes that career development begins with good conversations between employees and their managers that ensure regular feedback, and the Company has implemented tools and annual processes that allow all employees in conjunction with their managers to explore possibilities and drive development action.

All employees work with their managers to create annual Individual Development Plans with specific objectives and resource requirements.

We encourage our employees to develop both breadth and depth of experience, to build transferable skills, broaden perspective and to hone technical skill sets.

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.

We also conduct an annual Leadership Summit that is focused on aligning leaders around a common set of organizational priorities;

building and fostering Collegium’s culture;

facilitating knowledge exchange and development amongst Collegium’s leaders;

and fueling networking and collaboration across the organization.

Diversity, Equity, and Inclusion

We are unwavering in our commitment to treat our colleagues with equal humanity, and we will be open-minded and

inclusive in our dealings with one other, both because these expectations flow from our Core Values and because creating a diverse, equitable, and inclusive environment improves our performance and our business.

When people feel appreciated and included, they can be more creative, innovative, and successful, which in turn drives commercial success and enhances shareholder value.

Leveraging the contributions of a diverse employee population creates an environment in which individual differences and capabilities are valued.

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

Consistent with this belief, we are committed to ensuring that our employees are treated with respect and dignity to drive a culture of inclusion that values the broad perspective of each employee and fully harnesses the contributions they can make.

As of February 15, 2022, our workforce breakdown with respect to gender and self-reported race and ethnicity was as follows:

Asian (Not Hispanic or Latino)

Black or African American (Not Hispanic or Latino)

Hispanic or Latino

Prefer Not to Disclose

Two or More Races (Not Hispanic or Latino)

White (Not Hispanic or Latino)

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

In recent years, we launched a Diversity, Inclusion and Equity Council (the “Council”) comprised of a cross-functional group of employees, and chaired by our Chief Executive Officer, that focuses on listening to and learning from our lived experiences and aligning on actions that we can take to improve the diversity and inclusivity of our organization.

The Council is, among other activities, working to enhance our training curriculum with ongoing, mandatory diversity, equity, and inclusion education.

We have also engaged in a review of our recruitment and hiring practices with the intention of improving the diversity of Collegium at all levels.

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.

Executive Officers of the Company

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Director, President and Chief Executive Officer

Alison Fleming

Executive Vice President and Chief Technical Officer

Paul Brannelly

Colleen Tupper

Executive Vice President and Chief Financial Officer

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Branded Pharmaceuticals of Endo International plc, a specialty pharmaceutical company, from August 2016 to December 2016.

Before that, from April 2012 to August 2016, Mr.

Before that, from April

2012 to August 2016, Mr.

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

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

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.

Fleming's academic research focused on implantable drug delivery systems for cancer therapy.

Fleming is an inventor on several U.S.

patents and pending patent applications, and has authored numerous scientific publications and poster presentations in the field of novel drug delivery systems and abuse-deterrent opioid formulations.

Fleming graduated from the University of Massachusetts, Amherst in 1997 with a B.S.

in Chemical Engineering and received a Ph.D.

in Chemical and Biomolecular Engineering from Cornell University in 2002.

Paul Brannelly, Executive Vice President and Chief Financial Officer.

Brannelly has served as our Executive Vice President and Chief Financial Officer since February 2015.

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.

From August 2014 to November 2014, Mr.

Brannelly served as a consultant to Karyopharm.

Prior to joining Karyopharm, Mr.

Brannelly served as Vice President, Finance, Treasurer and Secretary at Verastem, Inc.

from August 2010 to May 2013.

From January 2010 to September 2011, Mr.

Brannelly held the position of Chief Financial Officer at the Longwood Fund, a venture capital firm aimed at investing in, managing and building healthcare companies, where he set up the financial and operational infrastructure following the closing of its first fund and eventually served as Chief Financial Officer of its two startup companies, Verastem and OvaScience, Inc.

From November 2005 to September 2009, he served as Vice President, Finance at Sirtris Pharmaceuticals, Inc., a biopharmaceutical company which GlaxoSmithKline plc purchased for $720 million in 2008.

Brannelly started his biopharmaceutical career at Dyax Corporation from September 1999 to May 2002, and subsequently moved on to positions of increasing responsibility at CombinatoRx Inc.

from May 2002 to November 2005, including as Vice President, Finance and Treasurer, where he led the initial public offering process.

Brannelly graduated from the University of Massachusetts at Amherst with a B.B.A.

in Accounting in 1995.

Colleen Tupper, Executive Vice President and Chief Financial Officer.

Tupper has served as our Executive Vice President and Chief Financial Officer since May 2021.

Prior to joining Collegium, Ms.

Tupper most recently served as Chief Financial Officer, U.S.

Business Unit as well as a member of the U.S.

Business Unit Executive Leadership Team and the Global Finance Leadership Team at Takeda from January 2019 to April 2021.

Prior to that role, Ms.

Tupper held several roles of increasing responsibility at Shire Pharmaceuticals (acquired by Takeda in 2019) including Vice President, U.S.

Commercial Finance, Vice President, Finance Integration Lead, and Vice President, Head of Finance Global Neuroscience and Ophthalmics.

Earlier in her career, Ms.

Tupper served in various finance and accounting roles at both Shire Pharmaceuticals and Antigenics (now Agenus).

Tupper received a B.S.

in Accounting from Franklin Pierce University.

Scott Dreyer, Executive Vice President and Chief Commercial Officer.

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and in October 2003, our predecessor changed its name to Collegium Pharmaceutical, Inc.

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.

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

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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