Table of Contents​

Table of Contents​

Table of Contents1

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Forward-Looking Statements

Forward-Looking Information​

ThisStatements made in this Annual Report on Form 10-K that are not statements of historical or this Form 10-K, includes forward-looking statements.current facts, such as those under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements discuss our current expectations and projections relating to our financial condition, results of operations, plans, objectives, future performance and business. These statements relate to future eventsmay be preceded by, followed by or to our future financial performance and involve known and unknown risks, uncertainties and other important factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied byinclude the forward-looking statements. Forward-looking statements include, but are not limited to, statements about:

In some cases, you can identify these statements by terms such aswords “aim,” “anticipate,” “believe,” “estimate,” “expect,” “forecast,” “intend,” “outlook,” “plan,” “potential,” “project,” “projection,” “seek,” “may,” “could,” “would,” “should,” “can,” “can have,” “likely,” the negatives thereof and other words and terms of similar meaning. These forward-looking

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Forward-looking statements reflect our management's beliefs and views with respect to future events and are based on estimates and assumptions as of the date of this Form 10-K and areinherently subject to risks, uncertainties and uncertainties. We discuss manyassumptions; they are not guarantees of these risks in greater detail under the heading “Risk Factors.” Moreover, we operate in a very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, youperformance. You should not place undue reliance on these forward-looking statements. Any forward-looking statements that we make in this Form 10-K speak only as of the date of such statement, and we undertake no obligation to update such statements to reflect events or circumstances after the date of this Form 10-K or to reflect the occurrence of unanticipated events. Comparisons of results for current and any prior periods are not intended to express any future trends or indications of future performance, unless expressed as such, and should only be viewed as historical data.

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future developments make it clear that projected results expressed or implied in such statements will not be realized, except as may be required by law.

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These and other risks are described under the future.

We obtained the industry, market and competitive position dataheading “Risk Factors” in this Annual Report on Form 10-K10-K. Those factors and the other risk factors described therein are not necessarily all of the important factors that could cause actual results or developments to differ materially from those expressed in any of our own internal estimatesforward-looking statements. Other unknown or unpredictable factors also could harm our results. Consequently, there can be no assurance that actual results or developments anticipated by us will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, us. Given these uncertainties, prospective investors are cautioned not to place undue reliance on such forward-looking statements.

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PART I

Item 1. Business

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Overview

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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 researchdevelopment efforts as well as from industryacquisitions and general publications and research surveys and studies conducted bylicensing relationships with third parties. We believe this data is accurate in all material respects asparties, to develop a portfolio of the date of this Form 10-K. In addition, projections, assumptions and estimates of the future performance of the industry in which we operate and our future performance are necessarily subject to a high degree of uncertainty and risk due to a variety of factors, including those described in “Risk Factors.”

PART I

Item 1. Business

Overview

We are a specialty pharmaceutical company focused on becoming the leader in responsible pain management by developing and commercializing innovative,meaningfully differentiated products for patients suffering fromuse 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.

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Xtampza ER

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Our first product,company was formed in 2002 to help address the opioid epidemic through the development of Xtampza ER, a pain treatment option designed with abuse deterrent properties. Xtampza ER is an abuse-deterrent, extended-release, oral formulation of oxycodone,oxycodone. Xtampza ER is formulated using our novel abuse-deterrent technology platform, DETERx, which provides extended-release delivery, while also providing barriers to common methods of abuse and misuse (e.g., crushing, chewing, heating, and injecting). This technology combines an active opioid ingredient with a widely prescribed opioid medication. fatty acid and waxes to form microspheres that are filled into a capsule. These wax-based microspheres are designed to resist particle size reduction and dose dumping when subjected to physical and chemical manipulation.

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In April 2016, the U.S.United States Food and Drug Administration or FDA,(“FDA”) approved our new drug application, or NDA, filingNew Drug Application (“NDA”) for Xtampza ER. Xtampza ER is indicated for the management of severe and persistent pain severe enough to requirethat requires an extended treatment period with a daily around-the-clock, long-term opioid treatmentanalgesic and for which alternative treatment options are inadequate. CertainThe approved labeling for Xtampza ER includes human abuse potential studies, are included in the approved label, as well as data supporting the administration of the product as a sprinkle or administered through feeding tubes. Xtampza ER’s label indicates a dosing regimen of one capsule every 12 hours, and it must be taken with food. In June 2016, we announcedcommercially launched Xtampza ER in the commercial launch of Xtampza.United States.

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Xtampza hasER, OxyContin, and the same active ingredient asauthorized generic versions of OxyContin OP, which is(which are identical to the largest selling abuse-deterrent,branded versions) are the only extended-release opioidoxycodone products marketed in the United States by dollars,as of January 2024. Xtampza ER and OxyContin (along with $1.7 billion in U.S. sales in 2017. We conducted a comprehensive preclinicalits authorized generics) feature the same active pharmaceutical ingredient (oxycodone) and clinical program for Xtampza consistent with FDA guidance on abuse-deterrence. These studies and clinical trials demonstrated that chewing, crushing and/or dissolving Xtampza, and then taking it orally or smoking, snorting, or injecting it did not meaningfully change its drug release profile or safety characteristics. By contrast, clinical trials performed by us and others — including head-to-head clinical trials comparing Xtampza with OxyContin OP — have shown that drug abusers can achieve rapid release and absorption offeature abuse-deterrent technologies – though the active ingredient by manipulating OxyContin OP using common household tools and methods commonly available on the Internet.abuse deterrent technologies are designed differently. In November 2017, we announced theFDA approval of a Supplemental New Drug Application to the FDA(“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 OP and a control (oxycodone hydrochloride immediate-release),. In the study, Xtampza ER maintained its extended-release pharmacokinetic profile when crushed, while OxyContin showed a rapid release of oxycodone when crushed with common household tools; crushed OxyContin was bioequivalent to crushed oxycodone IR. The sNDA also added results from an oral human abuse potential study and the addition of an oral abuse deterrent claim.claim to the label, making Xtampza ER the only single-agent extended-release oxycodone with oral, intranasal, and intravenous abuse-deterrent labeling.

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In addition,We are committed to ongoing monitoring and public dissemination of our preclinical studiesreal-world abuse and clinical trials have showndiversion 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

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schedule II opioid analgesics for three years after introduction into the U.S. market. 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 contentsPoison Center and Treatment Center Program cases involve self-reporting which may lead to: (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. 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 Xtampza capsule can be removed fromrate of abuse, misuse, and diversion of Xtampza.

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Nucynta Products

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The Nucynta Products are extended-release (“ER”) and immediate-release (“IR”) oral formulations of tapentadol. In November 2008, the capsule and sprinkled on food or into a cup, and then directly into the mouth, or administered through feeding tubes, without compromising their drug release profile, safety or abuse-deterrent characteristics. By contrast, OxyContin OP, which is formulated in hard tablets, has a black box warning label stating that crushing, dissolving, or chewing can cause rapid release and absorption of a potentially fatal dose of the active ingredient. We believe that Xtampza can address the pain management needs of patients in the United States who have difficulty swallowing and suffer from pain severe enough to require daily, around the clock, long-term opioid treatment and for which alternative treatment options are inadequate.

In December 2017, we entered into a Commercialization Agreement with Depomed, Inc., or Depomed, pursuant to which Depomed agreed to grant us a sublicense of certain of its intellectual property related toFDA approved Nucynta ER and Nucynta IR, or theIR. Nucynta Products, for commercialization of such products in the United States, the District of Columbia and Puerto Rico. We closed the transactions contemplated by the Commercialization Agreement, as amended, on January 9, 2018 and we began marketing the Nucynta Products in February 2018. Nucynta ER is an extended release formulation of tapentadol that is indicated for the management of severe and persistent pain severe enough to requirethat requires an extended treatment period with a daily around the clock, long term opioid treatment,analgesic, including neuropathic pain associated with diabetic peripheral neuropathy in adults, and for which alternate treatment options are inadequate. Nucynta IR is an immediate release formulation of tapentadol that is indicated for the management of moderate to severe acute pain in adults.

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individuals (e.g., nursing home residents, prisoners), military personnel, or children, or the costs associated with caregiving. The estimated annual costs of chronic pain exceed the costs for heart disease, cancer, and diabetes.

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Role of Prescription Opioids in the Treatment of Pain

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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 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 fixed annual minimum royalty during the first four yearslonger period of consistent blood levels of the Commercialization Agreement,active drug as compared to immediate-release formulations.

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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. 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. 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.

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Increasingly, practitioners and regulators are focusing on multidisciplinary, multimodal approaches to pain management, including exercise, physical therapy and psychotherapy, and opioid and non-opioid medications. Recognizing the role that opioid therapy continues to play in effective management of moderate to severe pain in appropriate patients, these groups are advocating for best practices that support appropriate opioid prescribing to help mitigate the risks of abuse, addiction and other adverse events associated with prescription opioids.

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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 certain conditions.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. These effects contribute to the attractiveness of opioids for abuse and, indeed, the U.S. Centers for Disease Control and Prevention (“CDC”) has described abuse of prescription drugs in the United States as a vast and deadly epidemic. The beginning of the opioid overdose epidemic in the late 1990s was marked by a rise in prescription opioid overdose deaths. 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.

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

Onsolis​

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”). By manipulating these products, people who abuse opioids achieve a more intense euphoria as a result of rapid increases in the blood concentration of the API.

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In May 2016, we licensedresponse to issues surrounding abuse of prescription opioids, pharmaceutical companies have developed novel, abuse-deterrent formulation strategies. Abuse-deterrent formulations, including the DETERx platform that is incorporated in Xtampza ER, target the known or expected routes of abuse, such as crushing in order to snort or dissolving in order to inject, for the specific opioid drug substance. The FDA has encouraged the development of prescription opioids with abuse-deterrent formulations to help combat the opioid crisis, and expanding access to abuse deterrent formulations is part of the FDA’s comprehensive Opioids Action Plan. These technologies, however, do not eliminate the possibility of

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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.

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Legislative and Regulatory Actions

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In response to widespread prescription opioid abuse, the U.S. rightsgovernment and a number of state legislatures enacted new legislation and regulations intended to developfight the opioid epidemic. At the federal level (in addition to the DEA and commercialize Onsolis from BioDelivery Sciences International, Inc.FDA efforts discussed elsewhere in this Annual Report on Form 10-K), or BDSI. Onsolis is a Transmucosal Immediate-Release Fentanyl film indicatedin 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. The updated CDC guidelines note that although opioids should not be considered first-line therapy for pain management, of breakthrough pain in cancerthis does not mean that patients 18 years of ageshould be required to sequentially fail nonpharmacologic and older, who are already receiving and who are tolerantnonopioid therapy before proceeding to opioid therapy, but rather the expected benefits specific to the clinical context should be weighed against risks before initiating therapy.

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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 their underlying persistent cancer pain. In December 2017, after a reviewthe evaluation and management of our product portfolio, we provided written notice to BDSIcare for patients with chronic pain who are on or being considered for opioid treatment. These guidelines are grounded in patient-centered care and the 2022 update provides algorithms for determining the appropriateness of terminationopioids for chronic pain, determining the initiation of opioids, and maintaining, tapering, discontinuing or switching from full agonist opioid treatment.

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While much, if not most, of the Licensestate level efforts have focused primarily on increasing people’s access to substance abuse treatment and Development Agreement dated May 11, 2016,harm reduction measures, some initiatives more directly impact manufacturers and distributors of prescription opioid products; these laws include requirements that manufacturers fund statewide drug take-back programs or pay opioid-specific taxes or “impact fees” and laws that limit the License Agreement, which termination will be effective pursuantamount of opioid products that a physician may prescribe. Recent years have also seen a variety of proposed and enacted laws and regulations at the federal, state and local level intended to reduce, or limit increases in, pharmaceutical prices, including prescription drug price disclosure laws. Other jurisdictions may enact similar or novel measures intended to reduce or constrain the growth of pharmaceutical spending or otherwise impose policy measures (either opioid-specific or applicable to the terms of such agreement on March 8, 2018. Upon such termination of the License Agreement,pharmaceutical industry as a whole) that could increase our rights to develop and commercialize Onsolis will revert to BDSI.operating costs associated with compliance.

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Manufacturing of DETERxOur Products and Product Candidates

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Overview

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Xtampza and our product candidates created with our DETERx technology platform areER is manufactured using a proprietary process. This process is reproducible, scalable, and cost‑efficient,cost-efficient, and we believe that the microsphere formulation — and the related manufacturing process — is unique in the extended‑releaseextended-release opioid market.

To date, we have produced Xtampza atER through a contract manufacturing organization, Patheon. The existing Patheon, facility has the capacitya subsidiary of Thermo Fisher Scientific, pursuant to support our commercialization of Xtampza during the first several years after commercial launch. We are working with Patheon to builda third-party supply agreement. Our microsphere production is currently conducted in a dedicated manufacturing capacity at Patheon’s existing facility.suite as we transitioned the microsphere production to the new suite in 2021. Patheon has an established record of manufacturing FDA-approved products approved in the United States, including products containing controlled substances.

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

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Drug Substances

The active ingredient usedNucynta Products are manufactured pursuant to supply agreements with third-party manufacturers. Nucynta ER was historically produced by Janssen at a facility in Xtampza, oxycodone base, is an odorless white crystalline powder. We currently procure this active ingredientPuerto 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 single U.S.‑based manufacturer. If our current suppliertechnology transfer program to enable manufacturing of Nucynta ER at Patheon in Cincinnati, Ohio. Nucynta ER is currently manufactured by Patheon. Nucynta IR is manufactured by Halo Pharmaceutical, Inc. in Whippany, New Jersey.

unable to supply oxycodone base in​

Allentown, Pennsylvania where it is converted into individual dosage units and, ultimately, into finished goods. For the quantities and at the times we require it,Belbuca product portfolio, we are aware of other suppliers who we would expectcurrently 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.

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Drug Substances

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The API used to be able to satisfyformulate the products in our commercial orders.portfolio and DEA drug scheduling are as follows:

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Oxycodone, base istapentadol, and buprenorphine are classified as a narcotic controlled substancesubstances under U.S. federal law. Xtampza is,ER and we expect that our product candidates will be,the Nucynta Products are classified by the U.S. Drug Enforcement Administration, or DEA as Schedule II controlled substances, meaning that theythese products have a high potential for abuse and dependence among drugs thatbut are recognized as having an accepted medical use. Consequently, we expect thatBelbuca 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 our product candidates will bethese products are subject to a high degree of regulation, as described in more detail under the caption “— GovernmentalGovernment Regulation — DEA and Opioid Regulation.”

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We currently procure the API used in our products from a sole supplier or limited number of suppliers.

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Marketing and Commercialization

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We are in the process of commercializing Xtampza and the Nucynta Productscommercialize our products in the United States with a direct sales force. We plan to explore out‑licensing partnerships for Xtampza in other international markets, such as Canada, Australia and Japan, as well as countries in Latin America and Europe.

The members of our management team who are leading the commercialization of Xtampza and the Nucynta Products have substantial experience in pharmaceutical sales and marketing. We have a dedicated field sales force, consisting of approximately 131110 sales professionals,representatives and managers, to call on the approximately 11,000 physicians10,000 health care professionals who write approximately 58%66% of the branded extended‑release oralextended-release opioid prescriptions in the United States, with a primary focus on pain specialists. In addition, we deploy a focused sales force of approximately 14 specialty sales representatives to call on hospitals. In addition, we employ medical sales liaisons, or MSLs, to respond to clinician inquiries about Xtampza. We also employ a market‑accessmarket-access team to support our formulary approval and payor contracting.

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We are continuing to execute our commercialization strategy with the input of key opinion leaders in the field of pain management, as well as healthcare practitioners. We have developed positioning and messaging campaigns, a publication strategy, initiatives with payor organizations, and distribution and national accounts strategies. Our marketing strategy includesfocuses on increasing awareness of the differentiated features of Xtampzaour products. As an integral part of educating clinicians regarding the properties and differentiated profiles of our products, our sales force is trained to share information relating to significant risks associated with prescription opioids, including risks relating to addiction, abuse, and misuse.

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We primarily sell our products to wholesalers that, in turn, distribute our products to retail outlets (such as drug store and supermarket chains and independent pharmacies), managed health care organizations and government agencies. Customers in the Nucynta Productsmanaged health care market include health maintenance organizations, nursing homes, hospitals, clinics, pharmacy benefit management companies and increasing awareness of solutions for patients with CPD who require or would benefit from extended‑release opioids.mail order customers.

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Intellectual Property

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We regard theThe protection of patents, designs, trademarks and other proprietary rights that we own or license asis critical to our success and competitive position. Our patent portfolio directed toward Xtampza and our DETERx technology consists ofER is protected by twelve issued patents in the United States (seven of which claim compositions of matter, three of which claims(which cover both compositions of matterthe abuse-deterrent technology and methods of use, and two that claim methods of use)using it to treat patients), one granted and two pending applications in the European Patent Office, two issued patents in Canada, and one issued patent in each of Japan and Australia. Finally, we have six patent applications pending in the United States, one pending patent application in each of Canada and Japan, and one pending PCTPatent Cooperation Treaty (“PCT”) application. Our issued U.S. patents are projected to expire in 2023, 2025, 2030, and 2036 and our pending patent applications in the United States, if issued, would be projected to expire in 2023, 2025, 2030 and 2036. 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.

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Our policyNucynta IR is protected by one issued patent in the United States (which covers both the drug substance and drug product) that is projected to patentexpire in 2025. Nucynta IR is also covered by New Patient Population exclusivity in

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pediatric patients that is projected to expire in 2026. Nucynta ER is protected by four issued patents in the technology, inventions and improvements that we consider important toUnited States (which cover the development of our business, but only in those cases in which we believe that the costs of obtaining patent protection is justified by the commercial potentialdrug substance, drug product, certain characteristics of the technology,dosage form, and typically onlymethods of treating patients) that are projected to expire in those jurisdictions2024, 2025, and 2028. Belbuca is protected by three issued patents in the United States (which cover a method of treating patients) that we believe present significant commercial opportunitiesare projected to us. expire in 2027 and 2032.

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We have concluded that some of our technology is best protected as proprietary know‑how,know-how, rather than through obtaining patents. In some cases, we publishExcept for licenses from Grünenthal GmbH to commercialize the invention such that it becomes prior artNucynta Products in order for usthe United States and its territories, and a license from Shionogi to secure freedom to operatecommercialize Symproic in the United States and to prevent a third party from patenting the invention before us. Ourits territories, our technology and products are not in‑licensedin-licensed from any third party, and we own all of the rights to Xtampza and our

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Satisfaction of FDA pre‑marketpre-market approval requirements typically takes many years and the actual time required may vary substantially based upon the application type, complexity, and novelty of the product or disease.

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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.product candidate. The conduct of the preclinical tests must comply with federal regulations and requirements, including GLPs. The results of preclinical testing are submitted to the FDA as part of an IND application along with other information, including information about product chemistry, manufacturing and controls, and a proposed clinical trial protocol. Long‑termLong-term preclinical tests, such as animal tests of reproductive toxicity and carcinogenicity, may continue after the IND application is submitted.

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The IND automatically becomes effective 30 days after receipt by FDA unless, within the 30‑day time period, the FDA raises concerns or questions relating to one or more proposed clinical trials and places the clinical trial on hold, including concerns that human research subjects will be exposed to unreasonable health risks. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin.

Clinical trials involve the administration of the investigational new drug to healthy volunteers or subjects under the supervision of a qualified investigator. Clinical trials must be conducted: (i) in compliance with federal regulations includingand GCP, an international standard meant to protectfor the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, safetyintegrity, and wellbeingconfidentiality of trial subjects and to define the

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After completion of the required clinical testing, an NDA is prepared and submitted to the FDA. The FDA approvalconducts a preliminary review of all NDAs within the first 60 days after submission before accepting them for filing. Pursuant to agreements reached during reauthorization of the NDA is required before marketingPrescription Drug User Fee Act (“PDUFA”), the FDA has a goal of acting on most original NDAs within six months or ten months of the product may begin inapplication submission or filing date, depending on the United States. The NDA must includenature of the results of all preclinical, clinical,drug and other testing and a compilation of data relating to the product’s pharmacology, chemistry, manufacture, and controls. The cost of preparing and submitting an NDA is substantial. The submission of most NDAs is additionally subject to a substantial application user fee and the manufacturer and/or sponsor under an approved new drug application are also subject to annual product and establishment user fees. These fees are typically increased annually.

type. The FDA has 60 days from its receipta number of an NDAprograms intended to determine whether the application will be accepted for filing based on the agency’s threshold determinationhelp expedite testing, review, and approval of drug candidates that it is sufficiently complete to permit substantive review. Rather than accept an NDA for filing, then FDA may request additional information. In this event, the NDA must be resubmitted with the additional information and may be subject to payment of additional user fees. The resubmitted application is also subject to review before the FDA accepts it for filing. Once the submission is accepted for filing, the FDA begins an in‑depth substantive review.meet certain eligibility criteria. The FDA has established certain performance goals for the review of new drug applications. The agency endeavors to review applications for standard review drug products within 10 to 12 months of the acceptance for filing, and aims to review applications for drugs granted priority review, which may apply to drugs that the FDA determines offer major advances in treatment or provide a treatment where no adequate therapy exists, within six to eight months. The review process for both standard and priority review may be extended by FDA for three additional months to consider certain late‑submitted information, or information intended to clarify information already provided in the submission.

The FDA may also refer applications for novel drug products, or drug products that present difficult questions of safety or efficacy,effectiveness, to an advisory committee — typically a panel that includes clinicians and other experts — for review, evaluation, and a recommendation as to whether the application should be approved and under what conditions. The FDA is not bound by the recommendation of an advisory committee, but it generally follows such recommendations. In addition, before approving an NDA,

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If the FDA will typically inspect one or more clinical sites to assure compliance with

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to educate patients in the safe use, storage, and disposal of opioids; and information provided to prescribers ofabout the existence of the REMS and the need to successfullystrong recommendation that they complete the necessaryavailable training. Prescriber training required to be offered as part of the REMS is conducted by accredited, independent continuing education providers, without cost to healthcare professionals, under unrestricted grants funded by the opioid analgesic manufacturers. Moreover, REMS assessments must be submitted on an annual basis to assess the extent to which the ETASU are meeting the goals of the REMS and whether the goals or elements should be modified.

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As part of the FDA’s OpioidIn September 2018, and pursuant to its Opioids Action Plan, the agency intendsFDA approved the final class-wide REMS, which includes several measures to update the extended-release and long-acting opioid REMS after having evaluated existing requirements and considered recommendations from the joint meetingfacilitate communication of the Drug Safetyrisks associated with opioid pain medications to patients and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory

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As part of the sales and marketing process, pharmaceutical companies frequently provide samples of approved drugs to physicians. The Prescription Drug Marketing Act, or PDMA, and associated regulations, impose certain recordkeeping and reporting requirements and other limitations on the distribution of drug samples to physicians. The PDMA also requires that state licensing of distributors who distribute prescription drugs meet certain federal guidelines that include minimum standards for storage, handling and record keeping. In addition, the PDMA and a growing majority of states also impose certain drug pedigree requirements on the sale and distribution of prescription drugs. The PDMA sets forth civil and criminal penalties for violations. In 2010, a statutory provision was enacted that required manufacturers and authorized distributors of record to report on an annual basis certain information about prescription drug samples they distributed. The FDA issued a draft compliance policy guide on the reporting requirement. The FDA stated that it would exercise enforcement discretion with regard to companies that have not submitted reports until the FDA finalizes the reporting requirement and/or provides notice that it is revising its exercise of enforcement discretion.

The FDA may require post‑approvalpost-approval studies, including post-marketing surveillance and observational studies and clinical trials, if the FDA finds that scientific data, including information regarding related drugs, deem it appropriate.warrant them. 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 serious 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. 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.

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The Hatch‑WaxmanFDA held a meeting of the Anesthetic and Analgesic Drug Products Advisory Committee on April 19, 2023. The committee discussed post-marketing requirements (“PMRs”) 3033-11, issued to holders of NDAs for extended-release and long-acting opioid analgesics to evaluate long-term efficacy of opioid analgesics and the risk of opioid-induced hyperalgesia. The discussion focused on a clinical trial designed to address these objectives. We participated in this meeting and as a result, the proposed design of study 3033-11, the enriched enrollment randomized withdrawal design was not supported. As part of the Opioid PMR Consortium, Collegium is working with the FDA to redesign study 3033-11.

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The Hatch-Waxman Amendments

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Orange Book Listing

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In seeking approval for a drug through an NDA, applicants are required to list with the FDA each patent whosewith claims that cover the applicant’s product. Upon approval of a drug, each of the patents listed in the application for the drug is then published in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. 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 abbreviated NDA, or ANDA. An ANDA provides for marketing of a drug product that has the same active pharmaceutical ingredient in the same strengths and dosage form as the listed drugRLD and has been shown through bioequivalence testing to be therapeutically equivalent to the listed drug.RLD. Other than the requirement for bioequivalence testing, ANDA applicants are not required to conduct, or submit results of, preclinical or clinical tests to prove the safety or efficacy of their drug product. Drugs approved in this way are commonly referred to as “generic equivalents” to the listed drug and can often be substituted by pharmacists under prescriptions written for the original listed drug.

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The ANDA applicant is required to make certain certifications to the FDA concerning any patents listed for the approved product in the FDA’s Orange Book. Specifically, the applicant must certify that: (i) the required patent information has not been filed; (ii) the listed patent has expired; (iii) the listed patent has not expired, but will expire on a particular date and approval is sought after patent expiration; or (iv) the listed patent is invalid or will not be infringed by the new product. The ANDA applicant may also elect to submit a section viii statement certifying that its proposed ANDA label does not contain (or carves out) any language regarding the patented method‑of‑usemethod-of-use rather than make certifications concerning a listed method‑of‑usemethod-of-use patent. If the applicant does not challenge the listed patents, the ANDA application will not be approved until all the listed patents claiming the referenced product have expired.

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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. The NDA and patent holders may then initiate a patent infringement lawsuit in response to the notice of the Paragraph IV certification. The filing of a patent infringement lawsuit within 45 days of the receipt of a Paragraph IV certification automatically prevents the FDA from approving the ANDA until the earlier of 30 months, expiration of the patent, settlement of the lawsuit, or a decision in the infringement case that is favorable to the ANDA applicant.

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

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Exclusivity

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discussed in more detail below, that relies on the FDA’s findings of safety and effectiveness regarding thatthe NCE drug. A drugsponsor may obtain a three‑yearthree-year period of exclusivity for a change to thean approved drug, such as the addition of a new indication to the labeling or a new formulation, during which FDA cannot approve an ANDA or any Section 505(b)(2) NDA, if the supplement includes reports of new clinical trials (other than bioavailability clinical trials) essential to the approval of the supplement.

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An ANDA may be submitted one year before NCE exclusivity expires if a Paragraph IV certification is filed. If there is no listed patent in the Orange Book, there may not be a Paragraph IV certification, and, thus, no ANDA may be filed before the expiration of the exclusivity period. No ANDA application will receive final approval before any applicable non-patent exclusivity listed in the Orange Book for the referenced product has expired.

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Section 505(b)(2) NDAs

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Generally, drug products obtain FDA marketing approval pursuant to an NDA or an ANDA. A third alternative is a Section 505(b)(2) NDA which enables the applicant to rely, in part, on data not developedis a special type of NDA often used by the applicant, such as the FDA’s findings of safety and efficacy in the approval of a similar product or published literature in support of its application.

Section 505(b)(2) NDAs may provide an alternate path to FDAapplicants seeking approval for new or improved formulations or new uses of previously approved products.active moieties. Under Section 505(b)(2) permitsof the filingFederal Food, Drug, and Cosmetic Act, in lieu of developing all of the information normally required for approval of an NDA, where at least some of the information required for approval comes from clinical trials not conductedan applicant may rely, in part, on data developed by or for, the applicantanother party and for which the applicant has not obtained a right of reference. IfMost commonly, 505(b)(2) applicants rely on the Section 505(b)(2) applicant can establish that reliance on FDA’s previous findings of safety and efficacy is scientifically appropriate, iteffectiveness in a prior approval of a similar product (although they may eliminate the need to conduct certain preclinicalalso rely on information in published literature). A 505(b)(2) application that references a prior approval may seek approval for some or clinical trialsall of the new product. The FDA may also require companies to perform additional clinical trials referenced product’s labeled indications and/or provide additional materials to support the change from the approved product. The FDA may then approve the new product candidate for all, or some, of the label indications for whicha different indication not included in the referenced product has been approved, as well as for any new indication sought by the Section 505(b)(2) applicant.product’s label.

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To the extent that the Section 505(b)(2) applicant is relying on the FDA’s findings of safety and effectiveness for an already approved product, the applicant is required to certify to the FDA concerning any patents listed for the approved product in the Orange Book to the same extent that an ANDA applicant would. Thus, approval of a Section 505(b)(2) NDA can be stalled until all the listed patents claiming the referenced product have expired; until any non‑patentnon-patent exclusivity such as exclusivity for obtaining approval of a new chemical entity, listed in the Orange Book for the referenced product has expired; and, in the case of a Paragraph IV certification and subsequent patent infringement suit, until the earlier of 30 months, settlement of the lawsuit or a decision in the infringement case that is favorable to the Section 505(b)(2) applicant. In the interim period, the FDA may grant tentative approval. Tentative approval indicates that the FDA has determined that the applicant meets the standards for approval as of the date that the tentative approval is granted. Final regulatory approval can only be granted if the FDA is assured that there is no new information that would affect final regulatory/regulatory approval. As with traditional NDAs, a Section 505(b)(2) NDA may be eligible for three‑yearthree-year marketing exclusivity, assuming the NDA includes reports of new clinical trials (other than bioavailability clinical trials) essential to the approval of the NDA. For further detail regarding our litigation with Purdue regarding our Section 505(b)(2) NDA for Xtampza ER, refer to “Item 3. Legal Proceedings”.

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DisclosureDEA and Opioid Regulation

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Several of Clinical Trial Information

Sponsors of clinical trials of FDA‑regulatedour products including drugs, are required to register and disclose certain clinical trial information. Information related to the product, patient population, phase of investigation, clinical trial sites and investigators, and other aspects of the clinical trial is then made public as part of the registration. Sponsors are also obligated to post certain information regarding the results of their clinical trials after completion. Disclosure of the results of these trials can be delayed until the new product or new indication being studied has been approved. Competitors may use this publicly available information to gain knowledge regarding the progress of development programs.

DEA Regulation

Our first product, Xtampza, is regulated as a “controlled substance”substances” as defined in the Controlled Substances Act or CSA,(“CSA”), which establishes registration, security, recordkeeping, reporting, storage, distribution, importation, exportation,

The DEA typically inspects a facility to review its security measures prior to issuing a registration. Security requirements vary by controlled substance schedule, with the most stringent requirements applying to Schedule I and Schedule II substances. Required security measures include background checks on employees and physical control of inventory through measures such as cages, surveillance cameras and inventory reconciliations. Records must be maintained for the handling of all controlled substances, and periodic reports made to the DEA, for example distribution reports for Schedule I and II controlled substances, Schedule III substances that are narcotics, and other designated substances. Reports must also be made for thefts or losses of any controlled substance, and to obtain authorization to destroy any controlled substance. In addition, special permits and notification requirements apply to imports and exports of narcotic drugs.​

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In addition, a DEA quota system controls and limits the availability and production of controlled substances in Schedule I or II. Distributions of any Schedule I or II controlled substance must also be accompanied by special order forms, with copies provided toAnnually, the DEA. Because Xtampza is regulated as a Schedule II controlled substance, it is subject to the DEA’s production and procurement quota scheme. The DEA establishes annually an aggregate quota for how much active opioid ingredients, such as oxycodone and tapentadol, may be produced in total in the United States based on the DEA’s estimate of the quantity needed to meet legitimate scientific and medicinal needs. The limited aggregate amount of opioids that the DEA allows to be produced in the United States each year is allocated among individual companies, who must submit applications annuallyquarterly to the DEA for individual production and procurement quotas. WeXtampza ER and ourthe Nucynta Products are regulated as Schedule II controlled substances, and thus, are subject to the DEA’s production and procurement quota system. Our contract manufacturers must receive an annuala quarterly quota from the DEA in order to produce or procure any Schedule I or Schedule II substance, including oxycodone base for use in manufacturing Xtampza.Xtampza ER and tapentadol for use in manufacturing the Nucynta Products. The DEA may adjust aggregate production quotas and individual production and procurement quotas from time to time during the year, although the DEA has substantial discretion in whether or not to make such adjustments.

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

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The DEA also requires drug manufacturers to design and implement a system that identifies suspicious orders of controlled substances, such as those of unusual size, those that deviate substantially from a normal pattern and those of unusual frequency, prior to completion of the sale. A compliant suspicious order monitoring system includes well-defined due diligence, “know your customer” efforts and order monitoring.

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To enforce these requirements, the DEA conducts periodic inspections of registered establishments that handle controlled substances. Failure to maintain compliance with applicable requirements, particularly as manifested in loss or

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coupons, the furnishing of supplies or equipment, credit arrangements, payments of cash, waivers of payments, ownership interests and providing anything at otherless than its fair market value. Although there are a number of statutory exemptions and regulatory safe harbors protecting certain business arrangements from prosecution, the exemptions and safe harbors are drawn narrowly and practices that involve remuneration intended to induce prescribing, purchasing or recommending may be subject to scrutiny if they do not qualify for an exemption or safe harbor. Our practices may not meet all of the criteria for safe harbor protection from federal Anti‑Kickback Statute liability in all cases. The reach ofUnder the federal Anti‑KickbackAnti-Kickback Statute was broadened byand the recently enacted Affordable Care Act, which, among other things, amends the intent requirement of the federal Anti‑Kickback Statute such thatapplicable criminal healthcare fraud statutes contained within 42 U.S.C. § 1320a-7b, a person or entity no longer needs toneed not have actual knowledge of this statute or specific intent to violate it in order to have committed a violation. In addition, the Affordable Care Act provides that the government may assert that a claim including items or services resulting from a violation of the federal Anti‑Kickback Statute42 U.S.C. § 1320a-7b, constitutes a false or fraudulent claim for purposes of the federalcivil False Claims Act (discussed below) or the civil monetary penalties statute, which imposes fines against any person who is determined to have presented or caused to be presented claims to a federal healthcare program that the person knows or should know is for an item or service that was not provided as claimed or is false or fraudulent. Additionally, many states have adopted laws similar toThe federal Anti-Kickback Statute and implementing regulations provide for certain exceptions for “safe harbors” for certain discounting, rebating or personal services arrangements, among other things. However, the lack of uniform court interpretation of the Anti-Kickback Statute makes compliance with the law difficult. Violations of the federal Anti‑KickbackAnti-Kickback Statute some of which apply to referral of patients for healthcare items or services reimbursed by any third‑party payor, not only thecan result in significant criminal fines, exclusion from participation in Medicare and Medicaid programs in at least some cases, and do not contain safe harbors.

The federal False Claims Act imposes liability on any person or entity that,follow-on civil litigation, among other things, knowingly presents, or causes to be presented, a false or fraudulent claim for payment by aboth entities and individuals.

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Other federal healthcare program.fraud-related laws also provide criminal liability for violations. The “qui tam” provisions of the False Claims Act allow a private individual to bring civil actions on behalf of the federal government alleging that the defendant has submitted a false claim to the federal government, and to share in any monetary recovery. In recent years, the number of suits brought by private individuals has increased dramatically. In addition, various states have enacted false claims laws analogous to the False Claims Act. Many of these state laws apply where a claim is submitted to any third‑party payor and not merely a federal healthcare program. There are many potential bases for liability under the False Claims Act. Liability arises, primarily, when an entity knowingly submits, or causes another to submit, a false claim for reimbursement to the federal government. The False Claims Act has been used to assert liability on the basis of inadequate care, kickbacks and other improper referrals, improperly reported government pricing metrics such as Best Price or Average Manufacturer Price, improper promotion of off‑label uses not expressly approved by FDA in a drug’s label, and allegations as to misrepresentations with respect to the services rendered. To the extent we participate in government healthcare programs, our future activities relating to the reporting of discount and rebate information and other information affecting federal, state and third party reimbursement of our products, and the sale and marketing of our products and our service arrangements or data purchases, among other activities, may be subject to scrutiny under these laws. We are unable to predict whether we would be subject to actions under the False Claims Act or a similar state law, or the impact of such actions. However, the cost of defending such claims, as well as any sanctions imposed, could adversely affect our financial performance. Also, HIPAA created several new federal crimes, including healthcare fraud and false statements relating to healthcare matters. The healthcare fraudCriminal Healthcare Fraud statute, 18 U.S.C. § 1347 prohibits knowingly and willfully executing a scheme to defraud any healthcare benefit program, including private third‑partythird-party payors. The false statements statuteFederal criminal law at 18 U.S.C. § 1001, among other sections, prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services.

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practitioners, and to teaching hospitals, and manufacturers and applicable group purchasing organizations must reportas well as ownership and investment interests held by physicians (as defined above) and their immediate family members. Such reports

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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. In addition, federal consumer protection and unfair competition laws broadly regulate marketplace activities and activities that potentially harm consumers. There are also analogous state and foreign laws and regulations, such as state and foreign anti-kickback, false claims, consumer protection and unfair competition laws which may apply to pharmaceutical business practices, including but not limited to, research, distribution, sales and marketing arrangements as well as submitting claims involving healthcare items or services reimbursed by any third-party payor, including commercial insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government that otherwise restricts payments that may be made to the Centers for Medicare & Medicaid Services, or CMS, by the 90th day following the end of each subsequent yearhealthcare providers and CMS subsequently is to publish the reported information on a publicly available website.

There are also an increasing number ofother potential referral sources; state “sunshine” laws that require drug manufacturers to file reports with states onregarding pricing and marketing information. Manyinformation, such as the tracking and reporting of these laws contain ambiguities as to what is required to comply with the laws. Several states have enacted legislation requiring pharmaceutical companies to, among other things, establish marketing compliance programs, file periodic reports with the state, make periodic public disclosures on sales, marketing, pricing, clinical trialsgifts, compensation and other activities and/or register their sales representatives. Such legislation also prohibits pharmaciesremuneration and otheritems of value provided to healthcare entities from providing certain physician prescribing data to pharmaceutical companies for use in salesprofessionals and marketing and prohibits certain other sales and marketing practices. These laws may affect our future sales, marketing and other promotional activities by imposing administrative and compliance burdens on us. In addition, given the lack of clarity with respect to these laws and their implementation, our reporting actions could be subject to the penalty provisions of the pertinententities; state and federal authorities.local laws requiring the registration of pharmaceutical sales representatives; and state and foreign laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.

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Because of the breadth of these laws and the narrowness of availablethe statutory exceptions and regulatory exemptions,safe harbors available, it is possible that some of oura pharmaceutical manufacturer’s business activities could be subject to challenge under one or more of such laws. Efforts to ensure that business arrangements comply with applicable healthcare laws involve substantial costs. It is possible that governmental and enforcement authorities will conclude that a pharmaceutical manufacturer’s business practices do not comply with current or future statutes, regulations or case law interpreting applicable fraud and abuse or other healthcare laws and regulations. If our operationsany such actions are found to beinstituted against a pharmaceutical manufacturer, and it is not successful in violationdefending itself or asserting its rights, those actions could have a significant impact on its business, including the imposition of any of the federal and state laws described above or any other governmental regulations that apply to us, we may be subject to penalties, includingsignificant civil, criminal and significant civil monetaryadministrative penalties, damages, disgorgement, imprisonment, monetary fines, imprisonment,possible exclusion from participation in governmentMedicare, Medicaid and other federal healthcare programs, injunctions, recall or seizurereporting obligations and oversight if we become subject to integrity and oversight agreements to resolve allegations of products, total or partial suspensionnon-compliance, contractual damages, reputational harm, diminished profits and future earnings, and curtailment of production, denial or withdrawal of pre‑marketing product approvals, private qui tam actions brought by individual whistleblowers in the name of the government or refusal to allow us to enter into supply contracts, including government contracts and the curtailment or restructuring of our operations, any of which could adversely affect oura pharmaceutical manufacturer’s ability to operate ourits business and ourthe results of operations. ToIn addition, commercialization of any drug product outside the extent that any of our products are approved and sold in a foreign country, we mayU.S. will also likely be subject to similar foreign equivalents of the healthcare laws and regulations, which may include, for instance, applicable post‑marketing requirements, including safety surveillance, anti‑fraud and abuse laws, and implementation of corporate compliance programs and reporting of payments or transfers of value to healthcare professionals.mentioned above, among other foreign laws.

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Third‑PartyThird-Party Payor Coverage and Reimbursement

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The commercial success of Xtampza, the Nucynta Products and our product candidates, if approved,products will depend, in part, upon the availability of coverage and adequate reimbursement from third‑partythird-party payors at the federal, state and private levels. Third‑partyThird-party payors include governmental programs such as Medicare or Medicaid, private insurance plans and managed care plans. These third‑partythird-party payors may deny coverage or reimbursement for a product or therapy in whole or in part if they determine that the product or therapy was not medically appropriate or necessary. Also, third‑partythird-party payors

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In international markets, reimbursement and healthcare payment systems vary significantly by country, and many countries have instituted price ceilings on specific products and therapies.

Healthcare Reform

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In the United States, and foreign jurisdictions, there have been a number of legislative and regulatory changes to the healthcare system that could affect our future results of operations. In particular, there have been and continue to be a number of initiatives at the U.S. federal and state levels that seek to reduce healthcare costs. The Medicare Modernization Act imposed new requirements for the distribution and pricing of prescription drugs for Medicare beneficiaries. Under Part D, Medicare beneficiaries may enroll in prescription drug plans offered by private entities which will provide coverage of outpatient prescription drugs. Part D plans include both stand‑alonestand-alone prescription drug benefit plans and prescription drug coverage as a supplement to Medicare Advantage plans. Unlike Medicare Part A and B, Part D coverage is not standardized. Part D prescription drug plan sponsors are not required to pay for all covered Part D drugs, and each drug plan can develop its own drug formulary that identifies which drugs it will cover and at what tier or level. However, Part D prescription drug formularies must include drugs within each therapeutic category and class of covered Part D drugs, though not necessarily all the drugs in each category or class. Any formulary used by a Part D prescription drug plan must be developed and reviewed by a pharmacy and therapeutic committee. Government payment for some of the costs of prescription drugs may increase demand for our products for which we receive marketing approval.products. However, any negotiated prices for our products covered by a Part D prescription drug plan will likely be lower than the prices we might otherwise obtain. Moreover, while the Medicare Modernization Act applies only to drug benefits for Medicare beneficiaries, private payors often follow Medicare coverage policy and payment limitations in setting their own payment rates. Any reduction in payment that results from Medicare Part D may result in a similar reduction in payments from non‑governmentalnon-governmental payors.

The American Recovery and Reinvestment Act of 2009 provides funding for the federal government to compare the effectiveness of different treatments for the same illness. A plan for the research will be developed by HHS, the Agency for Healthcare Research and Quality and the National Institutes for Health, and periodic reports on the status of the research and related expenditures will be made to Congress. Although the results of the comparative effectiveness clinical trials are not intended to mandate coverage policies for public or private payors, it is not clear what effect, if any, the research will have on the sales of any product, if any such product or the condition that it is intended to treat is the subject of a study. It is also possible that comparative effectiveness research demonstrating benefits in a competitor’s product could adversely affect the sales of our product candidates. If third‑party payors do not consider our products to be cost‑effective compared to other available therapies, they may not cover our products as a benefit under their plans or, if they do, the level of payment may not be sufficient to allow us to sell our products on a profitable basis.​

In March 2010, the Affordable Care Act was enacted, which includes measures to significantly changechanged the way healthcare is financed by both governmental and private insurers. Among the provisions of the Affordable Care Act of importance to the pharmaceutical and biotechnology industry are the following:

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The American Taxpayer Relief Act of 2012 which, among other things, reduced Medicare payments to several providers and increased the statute of limitations period for the government to recover overpayments to providers from three to five years. These new 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.

In December 2017, The American Rescue Plan Act of 2021 eliminates the Tax Cutsstatutory Medicaid drug rebate cap, currently set at 100% of a drug’s average manufacturer price, for single source and Jobs Act, or the TCJA, repealed the shared responsibility payment for individuals who fail to maintain minimum essential coverage under section 5000Ainnovator multiple source drugs, beginning January 1, 2024. Removal of the Internal Revenue Code, commonly referred to as the individual mandate, beginning in 2019. The Joint Committee on Taxation estimates that the repeal willdrug rebate cap can result in paying rebate payments to Medicaid that are higher than the sale price of the drug.

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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. Department of Health and Human Services that would require manufacturers to charge a negotiated “maximum fair price” for certain selected drugs or pay an excise tax for noncompliance. Another component of the IRA includes the establishment of rebate payment requirements on Medicare Part D drugs which penalize price increases that outpace inflation. The IRA also redesigned Medicare Part D to reallocate cost across the various stakeholders: CMS, payors, manufacturers, and beneficiaries. Certain aspects of the Part D redesign take effect in 2024 which ultimately shifts some liability from beneficiaries to the payors. Starting in 2025, all remaining components of the Part D Redesign will take effect. Ultimately, the existing coverage gap will be removed and replaced with greater exposure for manufacturers after the beneficiary pays their deductible. Additionally, the exemption previously applied on the low-income subsidy (“LIS”) population has been removed and increases manufacturer rebate exposure for that population. Some manufacturers, including Collegium, will qualify for a “phase in” of rebate utilization for the LIS population which should limit our exposure in the short term, but will increase it over 13 million Americans losing their health insurance coverage overtime. The implementation of the next ten years, andIRA is likely to lead to increases in insurance premiums. It is uncertain how or whether this legislation may affect our customers and, accordingly, our financial operations.

Other Regulatory Requirements

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Talent Acquisition and Retention

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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 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.

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Employee Training and Development

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We incurred researchbelieve 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 expenses of $8.6 million, $14.9 millionaction. Our comprehensive performance review process ensures our employees are on track with their development throughout the year.

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Diversity, Equity, and $8.0 million forInclusion

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We are committed to fostering diversity, equity, and inclusion (“DEI”) in our workplace. We are unwavering in our commitment to treat our colleagues fairly, and we are open-minded and inclusive in our engagements with one other, our partners, and customers. We believe that when people feel appreciated and included, they are more creative, innovative, and successful, which in turn improves our business and performance and enhances shareholder value. We are committed to employing people whose diverse backgrounds contribute to innovation and allow us to approach the years ended December 2017, 2016complex issues that face our industry from many different perspectives.

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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 2015, respectively.attracting talent; creating and sustaining a work environment where all employees feel valued and engaged; and developing a strong reputation and strategic alliance partnerships with the communities we serve.

Employees

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As of December 31, 2017,2023, we had a total of 250 full‑197 employees with representation with respect to gender and self-reported race and ethnicity as follows:

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As in everything we do, we are committed to continuous improvement in this area. While we are proud of the diversity of backgrounds and identities that our workforce exhibits, we will make the necessary investments of time, employees. Of these, 19 were engagedresources, and engagement to make sustained improvements in full‑time researchthis area.

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Employee Health and development activities. NoneSafety

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 all employees are represented byand their families with access to a labor organization or under any collective‑bargaining arrangements. We consider our employee relations to be good.variety of innovative, flexible, and convenient health and wellness programs.

Our Executive Officers of the Company

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The following table lists the positions, names and ages of our executive officers as of March 1, 2018:February 22, 2024:

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Executive Officers

Michael T. Heffernan, R.Ph., Chairman,Joseph Ciaffoni, Director, President and Chief Executive Officer. Mr. Heffernan has servedCiaffoni was appointed as our President and Chief Executive Officer andof Collegium Pharmaceutical in July 2018. Mr. Ciaffoni joined us in May 2017 as a member of our board of directors since October 2003. Mr. Heffernan has over twenty-five years of experience in the pharmaceutical and related healthcare industries. He was previously the Founder, President and Chief Executive Officer of Onset Therapeutics, LLC, a dermatology-focused company that developed and commercialized products for the treatment of skin-related illnesses and was responsible for the spin-off of the business from the Company to create PreCision Dermatology, Inc. which was acquired by Valeant Pharmaceuticals International, Inc. Mr. Heffernan has held prior positions as Co-Founder, President and Chief Executive Officer of Clinical Studies Ltd., a pharmaceutical contract research organization that was sold to PhyMatrix Corp., and as President and Chief Executive Officer of PhyMatrix. Mr. Heffernan started his career at Eli Lilly and Company, where he served in numerous sales and marketing roles. He serves on the board of directors of Keryx Biopharmaceuticals, Inc (NASDAQ: KERX) (July 2016 to present) and Veloxis Pharmaceuticals A/S (CPH: VELO) (March 2015 to present). Mr. Heffernan previously served on the board of directors and as Chairman of Ocata Therapeutics, Inc. (NASDAQ: OCAT), Cornerstone Therapeutics Inc. (now known as Chiesi USA, Inc.) (NASDAQ: CRTX) and numerous privately held companies. Mr. Heffernan graduated from the University of Connecticut with a B.S. in Pharmacy in 1987 and is a Registered Pharmacist.

Joseph Ciaffoni, Executive Vice President and Chief Operating Officer. Mr. Ciaffoni has served as our Executive Vice President and Chief Operating Officer since May 2017. Prior to joining us, Mr. Ciaffonihe served as President, U.S. Branded Pharmaceuticals of Endo International plc from August 2016 until May 2017.plc. Before that, Mr. Ciaffoni held various positions of increasing responsibility at Biogen, Idec since 2012, including Senior Vice President, Global Specialty Medicines Group, Senior Vice President, U.S. Commercial and Vice President, U.S. Neurology Field Operations and Marketing. Prior to joining Biogen, Idec, Mr. Ciaffonihe was Executive Vice President and Chief Operating

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Alison B. Fleming, Ph.D.Thomas Smith, M.D., Chief Technology Officer.Dr. Fleming has served as our Executive Vice President and Chief TechnologyMedical Officer. Dr. Smith has served as our Chief Medical Officer since March 2022 following the acquisition of BDSI. Dr. Smith has more than twenty-five years of experience in a variety of leadership roles at various major pharmaceutical companies, including serving as the Chief Medical Officer for BDSI from July 2018 to March 2022, Charleston Laboratories from January 2017.2017 to July 2018, Ameritox and Mallinckrodt Pharmaceuticals. Prior to being our Chief Technology Officer,these, Dr. Fleming led our development team as our Vice President, Product Development since October 2002. Prior to joining us,Smith served in scientific, medical and clinical leadership roles at Abbott Laboratories, Teva Pharmaceuticals and Kendle International. He is a member of several medical and scientific societies, including the American Medical Association and the American Academy of Family Physicians. Dr. Fleming's academic research focused on implantable drug delivery systems for cancer therapy. Dr. 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. In 2001, Dr. Fleming was the recipient of the Jorge Heller Journal of Controlled Release Outstanding Paper Award. Dr. Fleming graduatedSmith earned his M.D. from the Indiana University School of Massachusetts, Amherst in 1997 withMedicine and a B.S. in Chemical Engineering and received a Ph.D. in Chemical and Biomolecular Engineering from Cornell University in 2002.Purdue University.

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Our Corporate Information

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

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Our predecessor was incorporated in Delaware in April 2002 under the name Collegium Pharmaceuticals, Inc. Inand in October 2003, our predecessor changed its name to Collegium Pharmaceutical, Inc. In 2010, our predecessor divested its subsidiary, Onset Therapeutics, LLC to PreCision Dermatology, 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. Since 2010, we have devoted substantially all of our resources to the development of our patented DETERx platform technology, the preclinical and clinical advancement of our product candidates, the commercialization of Xtampza and the Nucynta Products, the acquisition and licensing of other products, and the creation and protection of related intellectual property.

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Available Information

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We maintain a website at www.collegiumpharma.com. We make available, free of charge on our website, our annual reportreports on Form 10‑K,10-K, quarterly reports on Form 10‑Q,10-Q, current reports on Form 8‑K8-K and all amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended or the (“Exchange Act,Act”), as soon as reasonably practicable after we electronically file those reports with, or furnish them to, the Securities and Exchange Commission or the SEC.(“SEC”). We also make available, free of charge on our website, the reports filed with the SEC by our officers, directors and 10% shareholders pursuant to Section 16 under the Exchange Act as soon as reasonably practicable after copies of those filings are provided to us by those persons. The SEC also maintains a website, at www.sec.gov, that contains reports, proxy and information statements and other information regarding us and other issuers that file electronically. The information contained on, or that can be accessed through, our website is not a part of or incorporated by reference in this Form 10‑K.10-K.

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Item 1A. Risk Factors.Factors

Investing in our common stock involves a high degree of risk. YouInvestors should carefully consider the risks described below, as well as all other information included in this Annual Report on Form 10-K, including our financial statements, the notes thereto and the section entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” If any of the following risks actually occurs, our business, financial condition, operating results, prospects and ability to accomplish our strategic objectives could be materially harmed. As a result, the trading price of our common stock could decline and youinvestors could lose all or part of yourtheir investment. Additional risks and uncertainties not presently known to us or that we currently deem immaterial may also impair our business operations and the market price of our common stock.

Risk Factors Summary

Our business is subject to a number of risks and uncertainties, including those risks discussed at length below. These risks include, among others, the following principal risk factors that make an investment in our company speculative or risky. You are encouraged to carefully review our full discussion of the material risk factors relevant to an investment in our business, which follows the brief bulleted list of our principal risk factors set forth below:

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Risks Related to Our Financial Position and Capital Needs

We have incurred significant losses since our inception and anticipate that we will continueOur ability to incur losses in the future.

We are an early commercial-stage pharmaceutical company. To date, we have focused on developing our first product, Xtampza. Investment in pharmaceutical product developmentmaintain profitability is highly speculative because it entails substantial upfront capital expenditures and significant risk that a product candidate will fail to gain regulatory approval or become commercially viable. Since 2010, we have only generated limited revenue from product sales, and we continue to incur significant research, development, commercialization and other expenses related to our ongoing operations. As a result, we are not profitable and have incurred losses in each period since January 1, 2011. For the year ended December 31, 2017, we reported a net loss of $74.9 million, and we had an accumulated deficit of $298.0 million at December 31, 2017.

We expect to continue to incur losses for the foreseeable future as we continue to commercialize Xtampza and the Nucynta Products and continue our development of, and seek regulatory approvals for, our product candidates. We may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business. The size of our future net losses will depend, in part, ondependent upon our ability to generate revenuescontinue successfully commercializing our products and on the rate of future growth of our expenses. If any of our product candidates fail in clinical trials or does not gain final regulatory approval, or if approved, fails to achieve market acceptance,products that we may never become profitable. Even if we achieve profitabilityacquire in the future, we may not be ablefuture. Our failure to sustain profitability in subsequent periods. Our prior lossesdo so successfully could impair our growth strategy and expected future lossesplans and could have had and will continue to have ana material adverse effect on our shareholders’ equitybusiness, financial position, and working capital.operating results.

We currently generate limited revenue from the sale of products and may never become profitable.

We began the commercial sale of our first product, Xtampza, in June 2016 and assumed responsibility for the sales and marketing of the Nucynta Products in January 2018, and in each case have generated limited revenue from product sales. Our ability to generate additional revenue and become profitablemaintain profitability depends upon our ability to successfullyrealize the full commercial potential of our products and to commercialize Xtampza, the Nucynta Products, our existing product candidates, andsuccessfully any other products and product candidates that we may in-license or acquire in the future. Even if we are able to successfully achieve regulatory approval for these product candidates, we do not know when any of these product candidates will generate revenue for us, if at all. Our ability to generate revenue from our current or future product candidatesproducts depends on a number of factors, including ourability to: