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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the year ended December 31, 2023
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from to
Commission File Number 001-37372
Collegium Pharmaceutical, Inc.
(Exact name of registrant as specified in its charter)
Virginia
(State or other jurisdiction of incorporation or organization)
03-0416362
(I.R.S. Employer Identification Number)
100 Technology Center Drive
Stoughton, MA
(Address of principal executive offices)
02072
(Zip Code)
(781) 713-3699
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Common stock, par value $0.001 per share
Trading Symbol(s)
COLL
Name of exchange on which registered:
The NASDAQ Global Select Market
Securities registered pursuant to Section 12(g) of the Act: None
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No ☒
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the
registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ⌧ No ☐
Indicate by check mark whether the registrant has submitted electronically, every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months
(or for such shorter period that the registrant was required to submit such files). Yes ⌧ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,”
“accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer ☒
Accelerated filer ☐
Non-accelerated filer ☐
(Do not check if
smaller reporting company)
Smaller reporting company ☐
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section
13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act
(15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☒
If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial
statements. ☐
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery
period pursuant to §240.10D-1(b). ☐
Indicate by checkmark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No ⌧
As of June 30, 2023, the last business day of the registrant’s most recently completed second fiscal quarter, the aggregate market value of the registrant’s common stock held by non-affiliates of the registrant was approximately
$741.8 million, based on the closing price of the registrant’s common stock on The NASDAQ Global Select Market on June 30, 2023 of $21.49 per share. Shares of the registrant’s common stock held by each officer and director
and each person known to the registrant to own 10% or more of the outstanding common stock of the registrant have been excluded in that such persons may be deemed affiliates. This determination of affiliate status is not a
determination for other purposes.
As of January 31, 2024, there were 31,959,828 shares of the registrant's common stock, par value, $0.001 per share, outstanding.
DOCUMENTS INCORPORATED BY REFERENCE
Portions of the registrant's definitive proxy statement for its 2024 Annual Meeting of Shareholders (the "Proxy Statement"), to be filed within 120 days of the registrant's year ended December 31, 2023, are incorporated by
reference in Part II and Part III of this Report on Form 10-K. Except with respect to information specifically incorporated by reference in this Form 10-K, the Proxy Statement is not deemed to be filed as part of this Form 10-K.
TABLE OF CONTENTS
Page No.
PART I
Item 1.
Item 1A.
Item 1B.
Item 1C.
Item 2.
Item 3.
Item 4.
PART II
Item 5.
Item 6.
Item 7.
Item 7A.
Item 8.
Item 9.
Item 9A.
Item 9B.
Item 9C.
PART III
Item 10.
Item 11.
Item 12.
Item 13.
Item 14.
PART IV
Item 15.
Item 16.
SIGNATURES
Business
Risk Factors
Unresolved Staff Comments
Cybersecurity
Properties
Legal Proceedings
Mine Safety Disclosures
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases
of Equity Securities
[Reserved]
Management’s Discussion and Analysis of Financial Condition and Results of Operations
Quantitative and Qualitative Disclosures about Market Risk
Consolidated Financial Statements and Supplementary Data
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
Controls and Procedures
Other Information
Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
Directors, Executive Officers and Corporate Governance
Executive Compensation
Security Ownership of Certain Beneficial Owners and Management and Related
Stockholder Matters
Certain Relationships and Related Transactions, and Director Independence
Principal Accountant Fees and Services
Exhibits and Financial Statement Schedules
Form 10-K Summary
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Forward-Looking Statements
Statements made in this Annual Report on Form 10-K that are not statements of historical or 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 may be preceded by, followed by or
include the words “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.
Forward-looking statements are inherently subject to risks, uncertainties and assumptions; they are not guarantees of
performance. You should not place undue reliance on these statements. We have based these forward-looking statements on
our current expectations and projections about future events. Although we believe that our assumptions made in connection
with the forward-looking statements are reasonable, we cannot assure you that the assumptions and expectations will prove
to be correct.
You should understand that the following important factors could affect our future results and could cause those results or
other outcomes to differ materially from those expressed or implied in our forward-looking statements:
● our ability to commercialize and grow sales of our products;
● our ability to maintain regulatory approval of our products, and any related restrictions, limitations, and/or
warnings in the label of an approved product;
● the size of the markets for our products, and our ability to service those markets;
● the success of competing products that are or become available;
● our ability to obtain and maintain reimbursement and third-party payor contracts with favorable terms for our
products;
● the costs of commercialization activities, including marketing, sales and distribution;
● the rate and degree of market acceptance of our products;
● changing market conditions for our products;
● the outcome of any patent infringement, opioid-related or other litigation that may be brought by or against us;
● the outcome of any governmental investigation related to the manufacture, marketing and sale of opioid
medications;
● the performance of our third-party suppliers and manufacturers;
● our ability to secure adequate supplies of active pharmaceutical ingredients for each of our products, manufacture
adequate quantities of commercially salable inventory and maintain our supply chain;
● our ability to effectively manage our relationships with licensors and to commercialize products that we in-license
from third parties;
● our ability to attract collaborators with development, regulatory and commercialization expertise;
● our ability to obtain funding for our business development;
● our ability to comply with the terms of our outstanding indebtedness;
● regulatory and legislative developments in the United States, including the adoption of opioid stewardship and
similar taxes that may impact our business;
● our ability to obtain and maintain sufficient intellectual property protection for our products;
● our ability to comply with stringent government regulations relating to the manufacturing and marketing of
pharmaceutical products, including U.S. Drug Enforcement Agency (“DEA”) compliance;
● our customer concentration, which may adversely affect our financial condition and results of operations;
● the accuracy of our estimates regarding expenses, revenue, capital requirements and need for additional
financing; and
● the other risks, uncertainties and factors discussed under the heading “Risk Factors” in this Annual Report on
Form 10-K.
In light of these risks and uncertainties, expected results or other anticipated events or circumstances discussed in this
Annual Report on Form 10-K (including the exhibits hereto) might not occur. We undertake no obligation, and specifically
decline any obligation, to publicly update or revise any forward-looking statements, even if experience or
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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.
These and other risks are described under the heading “Risk Factors” in this Annual Report on Form 10-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 forward-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.
Item 1. Business
Overview
PART I
Our mission is to build a leading, diversified specialty pharmaceutical company committed to improving the lives of people
living with serious medical conditions. We have leveraged our research and development efforts as well as acquisitions and
licensing relationships with third parties, to develop a portfolio of meaningfully differentiated products for use in the
treatment of moderate to severe pain. We commercialize our pain portfolio, consisting of Xtampza ER, Nucynta ER and
Nucynta IR (collectively the “Nucynta Products”), Belbuca, and Symproic, in the United States.
Xtampza ER
Our company was formed in 2002 to help address the opioid epidemic through the development of Xtampza ER, a pain
treatment option designed with abuse deterrent properties. Xtampza ER is an abuse-deterrent, extended-release, oral
formulation of oxycodone. Xtampza ER is formulated using our novel abuse-deterrent technology platform, DETERx,
which provides extended-release delivery, while also providing barriers to common methods of abuse and misuse (e.g.,
crushing, chewing, heating, and injecting). This technology combines an active opioid ingredient with a fatty acid and
waxes to form microspheres that are filled into a capsule. These wax-based microspheres are designed to resist particle size
reduction and dose dumping when subjected to physical and chemical manipulation.
In April 2016, the United States Food and Drug Administration (“FDA”) approved our New Drug Application (“NDA”)
for Xtampza ER. Xtampza ER is indicated for the management of severe and persistent pain that requires an extended
treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. The approved
labeling for Xtampza ER includes human abuse potential studies, as well as data supporting the administration of the
product as a sprinkle or through feeding tubes. Xtampza ER’s label indicates a dosing regimen of one capsule every 12
hours, and it must be taken with food. In June 2016, we commercially launched Xtampza ER in the United States.
Xtampza ER, OxyContin, and the authorized generic versions of OxyContin (which are identical to the branded versions)
are the only extended-release oxycodone products marketed in the United States as of January 2024. Xtampza ER and
OxyContin (along with its authorized generics) feature the same active pharmaceutical ingredient (oxycodone) and feature
abuse-deterrent technologies – though the abuse deterrent technologies are designed differently. In November 2017, we
announced FDA approval of a Supplemental New Drug Application (“sNDA”) for Xtampza ER to include comparative
oral pharmacokinetic data from a clinical study evaluating the effect of physical manipulation by crushing Xtampza ER
compared with OxyContin and a control (oxycodone hydrochloride immediate-release). In the study, Xtampza ER
maintained its extended-release pharmacokinetic profile when crushed, while OxyContin showed a rapid release of
oxycodone when crushed with common household tools; crushed OxyContin was bioequivalent to crushed oxycodone IR.
The sNDA also added results from an oral human abuse potential study and an oral abuse deterrent claim to the label,
making Xtampza ER the only single-agent extended-release oxycodone with oral, intranasal, and intravenous abuse-
deterrent labeling.
We are committed to ongoing monitoring and public dissemination of our real-world abuse and diversion data, regardless
of the results. The two main sources of real-world abuse, misuse, and diversion data are RADARS® and Inflexxion, an
IBH Company. The Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) System collects
product-and geographically-specific data on abuse, misuse, and diversion of prescription drugs through its multiple data
sources. Abuse, misuse, and diversion of Xtampza ER has remained low compared to commonly abused
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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 Poison 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 rate of abuse, misuse, and diversion of Xtampza.
Nucynta Products
The Nucynta Products are extended-release (“ER”) and immediate-release (“IR”) oral formulations of tapentadol. In
November 2008, the FDA approved Nucynta ER and Nucynta IR. Nucynta ER is indicated for the management of severe
and persistent pain that requires an extended treatment period with a daily opioid analgesic, including neuropathic pain
associated with diabetic peripheral neuropathy in adults, and for which alternate treatment options are inadequate. Nucynta
IR is indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative
treatments are inadequate in adults and pediatric patients aged 6 years and older with a body weight of at least 40 kg. In
August 2023, the FDA granted New Patient Population exclusivity for Nucynta IR in pediatric patients. This grant
extended the period of U.S. exclusivity for Nucynta IR from June 27, 2025 to July 3, 2026.
We began commercializing the Nucynta Products in 2018 pursuant to a commercialization agreement (the “Nucynta
Commercialization Agreement”) with Assertio Therapeutics, Inc. (formerly known as Depomed) (“Assertio”), pursuant to
which Assertio granted us a sublicense of certain of its intellectual property related to the Nucynta Products for
commercialization of such products in the United States. In February 2020, we acquired additional assets related to the
Nucynta Products from Assertio and assumed all commercialization responsibilities, including sales and marketing, for the
Nucynta Products through the acquisition of a license from Grünenthal Gmbh (the “Grünenthal License” and such
acquisition, the “Nucynta Acquisition”). Upon closing the Nucynta Acquisition, the Nucynta Commercialization
Agreement and our prior royalty obligation to Assertio ceased; our only remaining royalty obligation is to pay royalties
directly to Grünenthal Gmbh based on net sales of the Nucynta Products under the Grünenthal License.
Belbuca and Symproic
On March 22, 2022, we acquired BioDelivery Sciences International, Inc. (“BDSI”), a specialty pharmaceutical company
working to deliver innovative therapies for individuals living with serious and debilitating chronic conditions (the “BDSI
Acquisition”). Upon closing the BDSI Acquisition, we acquired Belbuca and Symproic.
Belbuca is a buccal film that contains buprenorphine, a Schedule III opioid, and was approved by the FDA in October 2015
for severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which
alternative options are inadequate. Symproic was approved by the FDA in March 2017 for the treatment of opioid-induced
constipation (“OIC”) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior
cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. We began shipping and
recognizing product sales related to Belbuca and Symproic in March 2022.
Pain, Pain Management, and Opioid Abuse in the United States
Acute and Chronic Pain
Pain can be classified along many different variables, including severity, duration and etiology. There are two broad
categories of pain based on duration: acute pain, or pain that is self-limited and generally requires treatment for no more
than up to a few weeks, and chronic pain, or pain that lasts beyond the healing of an injury or that persists longer than 3 to
6 months. The overall prevalence of chronic pain among adults in the United States is 20.9%, affecting approximately 51.6
million Americans. Additionally, 6.9% of the U.S. adult population, approximately 17.1 million people, suffer from high-
impact chronic pain that frequently limits life or work activities.
A 2011 report from the Institute of Medicine estimated that chronic pain costs the U.S. between $560.0 and $635.0 billion
per year in direct medical costs and lost productivity, which does not include the cost of care for institutionalized
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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.
Role of Prescription Opioids in the Treatment of Pain
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 longer
period of consistent blood levels of the active drug as compared to immediate-release formulations.
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.
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.
Prescription Opioid Abuse in the United States
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. 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.
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.
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.
In response 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.
Legislative and Regulatory Actions
In response to widespread prescription opioid abuse, the U.S. government and a number of state legislatures enacted new
legislation and regulations intended to fight the opioid epidemic. At the federal level (in addition to the DEA and FDA
efforts discussed elsewhere in this Annual Report on Form 10-K), in 2016 the CDC issued 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, this does not mean that patients should be
required to sequentially fail nonpharmacologic and nonopioid therapy before proceeding to opioid therapy, but rather the
expected benefits specific to the clinical context should be weighed against risks before initiating therapy.
In addition to CDC, the Department of Health and Human Services (“HHS”), and the Department of Veterans Affairs and
the Department of Defense (“VA-DoD”) issued clinical practice guidelines in 2017 and updated most recently in 2022 for
the evaluation and management of care for patients with chronic pain who are on or being considered for opioid treatment.
These guidelines are grounded in patient-centered care and the 2022 update provides algorithms for determining the
appropriateness of opioids for chronic pain, determining the initiation of opioids, and maintaining, tapering, discontinuing
or switching from full agonist opioid treatment.
While much, if not most, of the state level efforts have focused primarily on increasing people’s access to substance abuse
treatment and harm reduction measures, some initiatives more directly impact manufacturers and distributors of
prescription opioid products; these laws include requirements that manufacturers fund statewide drug take-back programs
or pay opioid-specific taxes or “impact fees” and laws that limit the amount of opioid products that a physician may
prescribe. Recent years have also seen a variety of proposed and enacted laws and regulations at the federal, state and local
level intended to reduce, or limit increases in, pharmaceutical prices, including prescription drug price disclosure laws.
Other jurisdictions may enact similar or novel measures intended to reduce or constrain the growth of pharmaceutical
spending or otherwise impose policy measures (either opioid-specific or applicable to the pharmaceutical industry as a
whole) that could increase our operating costs associated with compliance.
Manufacturing of Our Products
Overview
Xtampza ER is manufactured using a proprietary process. This process is reproducible, scalable, and cost-efficient, and we
believe that the microsphere formulation — and the related manufacturing process — is unique in the extended-release
opioid market. To date, we have produced Xtampza ER through a contract manufacturing organization, Patheon, a
subsidiary of Thermo Fisher Scientific, pursuant to a third-party supply agreement. Our microsphere production is
currently conducted in a dedicated manufacturing suite as we transitioned the microsphere production to the new suite in
2021. 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 at an alternative location (and with an alternative vendor) if necessary.
The Nucynta Products are manufactured pursuant to supply agreements with third-party manufacturers. Nucynta ER was
historically produced by Janssen at a facility in Puerto Rico pursuant to a supply agreement that we assumed from Assertio
in connection with the Nucynta Acquisition. In September 2022, we completed the transfer of the Nucynta ER
manufacturing process through a technology transfer program to enable manufacturing of Nucynta ER at Patheon in
Cincinnati, Ohio. Nucynta ER is currently manufactured by Patheon. Nucynta IR is manufactured by Halo Pharmaceutical,
Inc. in Whippany, New Jersey.
Belbuca and Symproic are manufactured pursuant to supply agreements with third-party manufacturers. Belbuca laminate
(i.e., bulk product) is produced by Adhesives Research in Glen Rock, Pennsylvania. Belbuca laminate is then sent to either
LTS Therapy Systems (formerly Tapemark) in St. Paul, Minnesota or Sharp Packaging Solutions in
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Allentown, Pennsylvania where it is converted into individual dosage units and, ultimately, into finished goods. For the
Belbuca product portfolio, we are currently qualifying alternate bulk and secondary packaging operations at our existing
manufacturer’s sites. Symproic is manufactured by UPM Pharmaceuticals in Bristol, Tennessee and packaged by Sharp
Packaging Solutions in Allentown, Pennsylvania.
Drug Substances
The API used to formulate the products in our portfolio and DEA drug scheduling are as follows:
Product
Xtampza ER
Nucynta IR
Nucynta ER
Belbuca
Symproic
API
Oxycodone
Tapentadol
Tapentadol
Buprenorphine
Naldemedine
DEA Drug Schedule
Schedule II
Schedule II
Schedule II
Schedule III
Not a controlled substance
Oxycodone, tapentadol, and buprenorphine are classified as narcotic controlled substances under U.S. federal law. Xtampza
ER and the Nucynta Products are classified by the DEA as Schedule II controlled substances, meaning these products have
a high potential for abuse and dependence but are recognized as having an accepted medical use. Belbuca is classified as a
Schedule III controlled substance, meaning it has a moderate to low potential for abuse. Due to the controlled substances
classification, the manufacturing, shipping, dispensing and storing of these products are subject to a high degree of
regulation, as described in more detail under the caption “— Government Regulation — DEA and Opioid Regulation.”
We currently procure the API used in our products from a sole supplier or limited number of suppliers.
Marketing and Commercialization
We commercialize our products in the United States with a dedicated field sales force, consisting of approximately 110
sales representatives and managers, to call on the approximately 10,000 health care professionals who write approximately
66% of the branded extended-release opioid prescriptions in the United States, with a primary focus on pain specialists. We
also employ a market-access team to support our formulary approval and payor contracting.
Our marketing strategy focuses on increasing awareness of the differentiated features of our products. As an integral part of
educating clinicians regarding the properties and differentiated profiles of our products, our sales force is trained to share
information relating to significant risks associated with prescription opioids, including risks relating to addiction, abuse,
and misuse.
We primarily sell our products to wholesalers that, in turn, distribute our products to retail outlets (such as drug store and
supermarket chains and independent pharmacies), managed health care organizations and government agencies. Customers
in the managed health care market include health maintenance organizations, nursing homes, hospitals, clinics, pharmacy
benefit management companies and mail order customers.
Intellectual Property
The protection of patents, designs, trademarks and other proprietary rights that we own or license is critical to our success
and competitive position. Xtampza ER is protected by twelve issued patents in the United States (which cover both the
abuse-deterrent technology and methods of using it to treat patients), one granted and two pending applications in the
European Patent Office, two issued patents in Canada, and one issued patent in each of Japan and Australia. Finally, we
have six patent applications pending in the United States, one pending patent application in each of Canada and Japan, and
one pending Patent Cooperation Treaty (“PCT”) application. Our issued U.S. patents are projected to expire in 2025, 2030,
and 2036 and our pending patent applications in the United States, if issued, would be projected to expire in 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.
Nucynta IR is protected by one issued patent in the United States (which covers both the drug substance and drug product)
that is projected to expire in 2025. Nucynta IR is also covered by New Patient Population exclusivity in
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pediatric patients that is projected to expire in 2026. Nucynta ER is protected by four issued patents in the United States
(which cover the drug substance, drug product, certain characteristics of the dosage form, and methods of treating patients)
that are projected to expire in 2024, 2025, and 2028. Belbuca is protected by three issued patents in the United States
(which cover a method of treating patients) that are projected to expire in 2027 and 2032.
We have concluded that some of our technology is best protected as proprietary know-how, rather than through obtaining
patents. Except for licenses from Grünenthal GmbH to commercialize the Nucynta Products in the United States and its
territories, and a license from Shionogi to commercialize Symproic in the United States and its territories, our technology
and products are not in-licensed from any third party, and we own all of the rights to Xtampza ER. We believe we have
freedom to operate in the United States and other countries, but there can be no assurance that other companies, known and
unknown, will not attempt to assert their intellectual property against us.
We also rely on trademarks and trade designs to develop and maintain our competitive position. We have received
trademark registration for Collegium Pharmaceutical, Inc., DETERx, and Xtampza ER in the United States, and acquired
trademarks associated with the Nucynta Products in connection with the Nucynta Acquisition and Belbuca and Symproic in
connection with the BDSI Acquisition.
Our business depends upon the skills, knowledge and experience of our scientific and technical personnel, as well as that of
our advisors, consultants and other contractors. To help protect our proprietary know-how that is not patentable, we rely on
trade secret protection and confidentiality agreements to protect our interests. To this end, we generally require our
employees, consultants and advisors to enter into confidentiality agreements prohibiting the disclosure of confidential
information and, in some cases, requiring disclosure and assignment to us of the ideas, developments, discoveries and
inventions important to our business. Additionally, these confidentiality agreements require that our employees, consultants
and advisors do not bring to us, or use without proper authorization, any third party’s proprietary technology.
Competition
Our industry is characterized by rapidly advancing technologies, intense competition, and a strong emphasis on proprietary
products. We face competition and potential competition from several sources, including pharmaceutical and biotechnology
companies, generic and branded drug companies, drug delivery companies and academic and research institutions.
However, our primary source of competition stems from the generic opioid market, including both long-acting/extended-
release and immediate-release opioid drugs. Most of the existing and potential competitors have significantly more
financial and other resources than we do. We believe the key competitive factors that will affect the commercial success of
our products include the therapeutic efficacy, convenience of dosing and distribution and, in the case of Xtampza ER, the
degree of abuse deterrence of competing products, as well as their safety, cost and tolerability profiles.
Government Regulation
FDA Approval Process
In the United States, pharmaceutical products are subject to extensive regulation by the FDA. The Federal Food, Drug, and
Cosmetic Act and other federal and state statutes and regulations govern the research, development, testing, manufacture,
storage, recordkeeping, approval, labeling, promotion and marketing, distribution, post-approval monitoring and reporting,
sampling, and import and export of pharmaceutical products. Failure to comply with applicable U.S. requirements may
subject a company to a variety of administrative or judicial sanctions, such as warning or untitled letters, product recalls,
product seizures, total or partial suspension of production or distribution, withdrawal of the product from the market,
injunctions, fines, civil penalties, and criminal prosecution. Failure to meet FDA requirements for approval would also
result in a medication not being approved for marketing.
The process of developing a pharmaceutical product and obtaining FDA approval to market the medication in the United
States typically involves:
● completion of preclinical laboratory and animal testing and formulation studies in compliance with the FDA’s
good laboratory practices (“GLP”) and regulations;
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● submission to the FDA of an Investigational New Drug (“IND”) application for human clinical testing, which
becomes effective 30 days after submission and, if not placed on clinical hold, before human clinical trials may
begin in the United States;
● approval by an independent institutional review board, at each clinical trial site before each trial may be initiated;
● performance of adequate and well-controlled human clinical trials in accordance with current good clinical
practices (“GCP”) and FDA regulations to establish the safety and effectiveness of the proposed drug product for
each indication for which FDA approval is sought;
● satisfactory completion of an FDA pre-approval inspection of the facility or facilities at which the product is
manufactured to assess compliance with the FDA’s current good manufacturing practices (“cGMP”) and
regulations;
● submission to the FDA of a NDA or, in the case of a generic drug, an abbreviated NDA (“ANDA”);
● satisfactory completion of a review by an FDA advisory committee, if convened; and
● FDA review and approval of the NDA or ANDA.
Satisfaction of FDA pre-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.
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 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-term preclinical tests, such as animal
tests of reproductive toxicity and carcinogenicity, may continue after the IND application is submitted.
Clinical trials involve the administration of the investigational new drug to healthy volunteers or subjects under the
supervision of a qualified investigator. Clinical trials must be conducted: (i) in compliance with federal regulations and
GCP, an international standard for 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, integrity, and confidentiality of trial subjects are protected; and (ii) under protocols detailing, among other things,
the objectives of the trial, the parameters to be used in monitoring safety, and any effectiveness criteria to be evaluated.
Clinical trials to support NDAs for marketing approval are typically conducted in three sequential phases, but the phases
may overlap or be combined.
● Phase 1: This phase includes the initial introduction of an investigational new drug into patients or healthy
volunteer subjects. These studies are typically closely monitored and designed to determine the metabolism and
pharmacological actions of the drug in humans, the side effects associated with increasing doses, and, in some
cases, early evidence of effectiveness.
● Phase 2: This phase includes well-controlled, closely monitored studies conducted in a relatively small number of
patients (typically no more than several hundred patients) to assess effectiveness of the drug for particular
indication(s) in patients with the diseases or condition under study as well as to determine the common short-term
side effects and risks associated with the drug.
● Phase 3: This phase includes expanded controlled and uncontrolled trials which are performed after preliminary
evidence suggesting effectiveness of the drug has been obtained. These studies typically include several hundred
to several thousand patients and are conducted to gather additional information about the effectiveness and safety
of the drug in order to evaluate the overall risk-benefit relationship and provide an adequate basis for labeling.
For opioid products designed to deter abuse, FDA guidance regarding studies and clinical trials dictates what types of
studies should be conducted to demonstrate abuse-deterrence, how those studies and clinical trials will be evaluated, and
what product labeling claims may be approved based on the results of those studies and clinical trials. There are four
categories of abuse-deterrence studies and clinical trials: Categories 1, 2 and 3 consist of pre-marketing studies and clinical
trials designed to evaluate a product candidate’s abuse potential under controlled conditions, while Category 4 studies
analyze post-market data to assess the impact of abuse-deterrent properties on actual abuse. The final guidance also
provides examples of product label claims that may be made based on the results of the corresponding studies and clinical
trials.
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After completion of the required clinical testing, an NDA is prepared and submitted to the FDA. The FDA conducts a
preliminary review of all NDAs within the first 60 days after submission before accepting them for filing. Pursuant to
agreements reached during reauthorization of the Prescription Drug User Fee Act (“PDUFA”), the FDA has a goal of
acting on most original NDAs within six months or ten months of the application submission or filing date, depending on
the nature of the drug and application type. The FDA has a number of programs intended to help expedite testing, review,
and approval of drug candidates that meet certain eligibility criteria. The FDA may refer applications for novel drug
products, or drug products that present difficult questions of safety or 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.
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. After receiving a
complete response letter, the applicant may resubmit the application addressing all deficiencies in the letter or withdraw the
application. Addressing the deficiencies noted by the FDA can be costly and can result in significant delays prior to
approval. Moreover, even if the applicant believes it has addressed the deficiencies, it is possible that approval may not
ultimately be obtained.
Where a sponsor wishes to expand the originally approved prescribing information, such as by adding a new indication, it
must submit and obtain approval of a sNDA. Changes to an indication generally require additional clinical studies, which
can be time-consuming and require the expenditure of substantial additional resources. Under PDUFA, the target timeframe
for the review of a sNDA to add a new clinical indication is six or ten months from the receipt date, depending on whether
or not the sNDA has priority review. As with an NDA, if the FDA determines that it cannot approve a sNDA in its current
form, it will issue a complete response letter as discussed above.
REMS
The FDA has the authority to require a Risk Evaluation and Mitigation Strategy (“REMS”), either as a condition of the
approval of an NDA or after approval. A REMS is a program to manage known or potential serious risks associated with a
drug product and may be required by the FDA to ensure that the benefits of a drug outweigh its risks. If the FDA
determines a REMS is necessary for a new drug, the drug sponsor must submit a proposed REMS plan as part of its NDA
prior to approval. The FDA may also impose a REMS requirement on a drug already on the market if the FDA determines,
based on new safety information, that a REMS is necessary to ensure that the drug’s benefits continue to outweigh its risks.
A REMS can include medication guides, communication plans for healthcare professionals, and Elements To Assure Safe
Use (“ETASU”). In addition, the REMS must include a timetable for periodically assessing the strategy, at a minimum, at
18 months, three years, and seven years after the REMS approval. The requirement for a REMS can materially affect the
potential market and profitability of a drug.
In July 2012, the FDA approved a class-wide REMS for extended-release and long-acting opioid products (Opioid
Analgesic REMS). Extended-release formulations of oxycodone, morphine, hydrocodone and hydromorphone, for
example, are required to have a REMS. The goal of the Opioid Analgesic REMS is to educate prescribers and other
healthcare providers (including pharmacists and nurses) on the treatment and monitoring of patients with pain.
Manufacturers subject to this class-wide REMS must work together to implement the REMS as part of the Opioid
Analgesic REMS Program Companies ("RPC"), which is a collaboration of drug product companies to implement a single
shared REMS to reduce the burden on the healthcare system accessed from the RPC REMs website. The content on this
website is determined by, hosted on behalf of, and is financially supported by the RPC. The central component of the
extended-release/long-acting opioid REMS program is an education program for healthcare providers who prescribe, and
healthcare providers involved in the treatment and monitoring of patients who receive opioid analgesics. Specifically, the
REMS includes a product-specific Medication Guide and the Patient Counseling Guide available for distribution to patients
who are dispensed the drug, as well as a number of ETASU. These ETASU include REMS-compliant accredited continuing
education for healthcare providers, which includes all healthcare providers who prescribe or are involved in the
management of patients with pain; information provided to prescribers that they can use
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to educate patients in the safe use, storage, and disposal of opioids; and information provided to prescribers about the
existence of the REMS and the strong recommendation that they complete the available training. Prescriber training
required to be offered as part of the REMS is conducted by accredited, independent continuing education providers,
without cost to healthcare professionals, under unrestricted grants funded by the opioid analgesic manufacturers. Moreover,
REMS assessments must be submitted on an annual basis to assess the extent to which the ETASU are meeting the goals of
the REMS and whether the goals or elements should be modified.
In September 2018, and pursuant to its Opioids Action Plan, the FDA approved the final class-wide REMS, which includes
several measures to facilitate communication of the risks associated with opioid pain medications to patients and health
care professionals. For the first time, FDA notified companies that have NDAs or ANDAs for certain opioid analgesic drug
products (“NDA/ANDA holders”) of the elements required for a single REMS for opioid analgesic products, whether
branded or generic. The REMS requires that training be made available to health care providers who are involved in the
management of patients with pain (including nurses and pharmacists) and requires that the education cover broad
information about appropriate pain management, including alternatives to opioids for the treatment of pain. In connection
with the 2018 REMS, the FDA also approved new product labeling containing information about the health care provider
education available through the 2018 REMS.
Advertising and Promotion
The FDA and other federal regulatory agencies closely regulate the marketing and promotion of drugs through, among
other things, guidance and regulations for direct-to-consumer advertising, communications regarding unapproved uses,
industry-sponsored scientific and educational activities, and promotional activities involving the internet. A product cannot
be commercially promoted before it is approved. 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. However, FDA regulations impose stringent
restrictions on manufacturers’ communications regarding off-label uses. Failure to comply with applicable FDA
requirements and restrictions in this area may subject a company to adverse publicity and enforcement action by the FDA,
the U.S. Department of Justice, or the Office of the Inspector General of HHS, as well as state authorities. This could
subject a company to a range of penalties that could have a significant commercial impact, including civil and criminal
fines and agreements that materially restrict the manner in which a company promotes or distributes drug products.
Post-Approval Requirements
Once an NDA is approved, a product will be subject to pervasive and continuing regulation by the FDA, including, among
other things, requirements relating to drug listing and registration, recordkeeping, periodic reporting, product sampling and
distribution, adverse event reporting and advertising, marketing and promotion restrictions. In addition, the Drug Supply
Chain Security Act (“DSCSA”), was enacted in 2013 with the aim of building an electronic system to identify and trace
certain prescription drugs and biologics distributed in the United States. The DSCSA mandates phased-in and resource-
intensive obligations for pharmaceutical manufacturers, wholesale distributors, and dispensers that culminated in
November 2023. The FDA has issued two compliance policy guidances that establish a one-year stabilization period from
November 2023 to November 2024 for trading partners to continue to build and validate interoperable systems and
processes to meet certain requirements of the DSCSA. The law’s requirements include the quarantine and prompt
investigation of a suspicious product, to determine if it is illegitimate, notifying trading partners and the FDA of any
illegitimate product, and compliance with product tracking and tracing requirements.
Adverse event reporting and submission of periodic reports is required following FDA approval of an NDA. The FDA also
may require, in addition to REMS discussed above, post-market testing, known as Phase 4 testing, and surveillance to
monitor the effects of an approved product, or the FDA may place conditions on an approval that could restrict the
distribution or use of the product. In addition, quality control, drug manufacture, packaging, and labeling procedures must
continue to conform to cGMPs after approval. Drug manufacturers and certain of their subcontractors are required to
register their establishments with the FDA and certain state agencies. Registration subjects entities to periodic announced
or unannounced inspections by the FDA or these state agencies, during which the agency inspects manufacturing facilities
to assess compliance with cGMPs. Regulatory authorities may withdraw product approvals, request product recalls, or take
other punitive action if a company fails to comply with regulatory standards, if it encounters problems following initial
marketing, or if previously unrecognized problems are subsequently discovered.
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The FDA may require post-approval studies, including post-marketing surveillance and observational studies and clinical
trials, if the FDA finds that scientific data, including information regarding related drugs, warrant them. The purpose of
such studies would be to collect additional information to assess a known serious risk or signals of serious risk related to
the drug or to monitor for or identify an unexpected serious risk when available data indicate the potential for such a risk.
The FDA may also require a labeling change if it becomes aware of new safety information that it believes should be
included in the labeling of a drug. 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.
The FDA held a meeting of the Anesthetic and Analgesic Drug Products Advisory Committee on April 19, 2023. The
committee discussed post-marketing requirements (“PMRs”) 3033-11, issued to holders of NDAs for extended-release and
long-acting opioid analgesics to evaluate long-term efficacy of opioid analgesics and the risk of opioid-induced
hyperalgesia. The discussion focused on a clinical trial designed to address these objectives. We participated in this
meeting and as a result, the proposed design of study 3033-11, the enriched enrollment randomized withdrawal design was
not supported. As part of the Opioid PMR Consortium, Collegium is working with the FDA to redesign study 3033-11.
The Hatch-Waxman Amendments
Orange Book Listing
In seeking approval for a drug through an NDA, applicants are required to list with the FDA each patent with claims that
cover the applicant’s product. Upon approval of a drug, each of the patents listed in the application for the drug is then
published in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the
Orange Book. Drugs listed in the Orange Book can, in turn, be cited by potential generic competitors as referenced listed
drugs (“RLDs”) in support of approval of an ANDA. 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 RLD and has been shown through
bioequivalence testing to be therapeutically equivalent to the 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.
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-use rather than make certifications concerning a
listed method-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.
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.
Exclusivity
Upon approval of an NDA for a new chemical entity (“NCE”), which is a drug that contains no active moiety that has been
approved by the FDA in any other NDA, that drug receives five years of marketing exclusivity during which time the FDA
cannot receive any ANDA seeking approval of a generic version of that drug or any Section 505(b)(2) NDA,
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discussed in more detail below, that relies on the FDA’s findings of safety and effectiveness regarding the NCE drug. A
sponsor may obtain a three-year period of exclusivity for a change to an approved drug, such as the addition of a new
indication to the labeling or a new formulation, if the supplement includes reports of new clinical trials (other than
bioavailability clinical trials) essential to the approval of the supplement.
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.
Section 505(b)(2) NDAs
A Section 505(b)(2) NDA is a special type of NDA often used by applicants seeking approval for new or improved
formulations or new uses of previously approved active moieties. Under Section 505(b)(2) of the Federal Food, Drug, and
Cosmetic Act, in lieu of developing all of the information normally required for approval of an NDA, an applicant may
rely, in part, on data developed by another party and for which the applicant has not obtained a right of reference. Most
commonly, 505(b)(2) applicants rely on the FDA’s findings of safety and effectiveness in a prior approval of a similar
product (although they may also rely on information in published literature). A 505(b)(2) application that references a prior
approval may seek approval for some or all of the referenced product’s labeled indications and/or for a different indication
not included in the referenced product’s label.
To the extent that the Section 505(b)(2) applicant is relying on the FDA’s findings of safety and effectiveness for an already
approved product, the applicant is required to certify to the FDA concerning any patents listed for the approved product in
the Orange Book to the same extent that an ANDA applicant would. Thus, approval of a Section 505(b)(2) NDA can be
stalled until all the listed patents claiming the referenced product have expired; until any non-patent exclusivity 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 approval. As with traditional NDAs, a Section 505(b)(2) NDA may be
eligible for three-year marketing exclusivity, assuming the NDA includes reports of new clinical trials (other than
bioavailability clinical trials) essential to the approval of the NDA. For further detail regarding our litigation with Purdue
regarding our Section 505(b)(2) NDA for Xtampza ER, refer to “Item 3. Legal Proceedings”.
DEA and Opioid Regulation
Several of our products are regulated as “controlled substances” as defined in the Controlled Substances Act (“CSA”),
which establishes registration, security, recordkeeping, reporting, storage, distribution, importation, exportation, and other
requirements administered by the DEA.
The DEA regulates controlled substances as Schedule I, II, III, IV or V substances. Schedule I substances have no
established medicinal use and may not be marketed or sold in the United States. A pharmaceutical product may be listed as
Schedule II, III, IV or V, with Schedule II substances considered to present the highest risk of abuse and Schedule V
substances the lowest relative risk of abuse among such substances.
Xtampza ER and the Nucynta Products are listed by the DEA as Schedule II controlled substances under the CSA, while
Belbuca is listed as a Schedule III controlled substance. Consequently, the manufacturing, shipping, storing, selling and use
of these products is subject to a high degree of regulation. Also, distribution and dispensing of these drugs are highly
regulated. Schedule II drugs are subject to the strictest requirements for registration, security, recordkeeping, and reporting.
Further, all Schedule II drug prescriptions must be signed by a physician, presented to a pharmacist, and may not be refilled
without a new prescription.
Annual DEA registration is required for any facility that manufactures, distributes, dispenses, imports, or exports any
controlled substance. The registration is specific to the particular location, activity, and controlled substance schedule. For
example, separate registrations are needed for import and manufacturing, and each registration will specify which
schedules of controlled substances are authorized.
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In addition, a DEA quota system controls and limits the availability and production of controlled substances in Schedule I
or II. Annually, the DEA establishes an aggregate quota for how much active opioid ingredients, such as oxycodone and
tapentadol, may be produced in total in the United States based on the DEA’s estimate of the quantity needed to meet
legitimate scientific and medicinal needs. The limited aggregate amount of opioids that the DEA allows to be produced in
the United States each year is allocated among individual companies, who must submit applications quarterly to the DEA
for individual production and procurement quotas. Xtampza ER and the Nucynta Products are regulated as Schedule II
controlled substances, and thus, are subject to the DEA’s production and procurement quota system. Our contract
manufacturers must receive a quarterly quota from the DEA to produce or procure any Schedule I or Schedule II substance,
including oxycodone base for use in manufacturing Xtampza ER and tapentadol for use in manufacturing the Nucynta
Products. 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.
Distributions of any Schedule I or II controlled substance must also be accompanied by special order forms, with copies
provided to the DEA.
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.
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 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. In certain circumstances, violations could result in
criminal proceedings.
Individual states also independently regulate controlled substances. We and our contract manufacturers are subject to state
regulation on the distribution of these products.
Federal laws have been enacted to address the national epidemics of prescription opioid abuse and illicit opioid use. In
2016, the Comprehensive Addiction and Recovery Act (“CARA”), was enacted to address the national epidemics of
prescription opioid abuse and heroin use. CARA expands the availability of naloxone for law enforcement and other first
responders, forms an interagency task force to develop best practices for pain management with opioid medications and
provides resources to improve state monitoring of opioids. The Substance Use-Disorder Prevention that Promotes Opioid
Recovery and Treatment for Patients and Communities Act (“SUPPORT Act”), which was signed into law in November
2018, includes a number of measures directed towards regulation and improvement of treatment for substance use-disorder
and increased coverage by the Centers for Medicare and Medicaid Services (“CMS”) of medically-assisted treatment
options. In addition, the SUPPORT Act requires HHS to report to Congress on existing barriers to access to abuse-deterrent
opioid formulations by Medicare Part C and D beneficiaries.
Healthcare Fraud and Abuse Laws and Compliance Requirements
We are subject to federal, state and local laws targeting fraud and abuse in the healthcare industry, violations of which can
lead to civil and criminal penalties, including fines, imprisonment and exclusion from participation in federal healthcare
programs. These laws are potentially applicable to us as both a manufacturer and a supplier of products and they also apply
to hospitals, physicians and other potential purchasers of our products. The applicable federal fraud and abuse laws apply
to products or services reimbursed by federal healthcare programs. Some states, however, have applicable fraud and abuse
laws that apply more broadly to include products or services reimbursed by private payors.
The federal Anti-Kickback Statute (“AKS”) (42 U.S.C. § 1320a-7b(b)) prohibits knowingly and willfully soliciting,
receiving, offering or providing remuneration, directly or indirectly, to induce either the referral of an individual, or the
furnishing, recommending, or arranging for a good or service, for which payment may be made under a federal healthcare
program such as the Medicare and Medicaid programs. Remuneration is not defined in the federal Anti-Kickback Statute
and has been broadly interpreted to include anything of value, including for example, gifts, discounts,
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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 less than its fair market value. Under the federal Anti-Kickback Statute and the
applicable criminal healthcare fraud statutes contained within 42 U.S.C. § 1320a-7b, a person or entity need not have actual
knowledge of this statute or specific intent to violate it in order to have committed a violation. In addition, the government
may assert that a claim including items or services resulting from a violation of 42 U.S.C. § 1320a-7b, constitutes a false or
fraudulent claim for purposes of the civil False Claims Act (discussed below) or the civil monetary penalties statute, which
imposes fines against any person who is determined to have presented or caused to be presented claims to a federal
healthcare program that the person knows or should know is for an item or service that was not provided as claimed or is
false or fraudulent. The federal Anti-Kickback Statute and implementing regulations provide for certain exceptions for
“safe harbors” for certain discounting, rebating or personal services arrangements, among other things. However, the lack
of uniform court interpretation of the Anti-Kickback Statute makes compliance with the law difficult. Violations of the
federal Anti-Kickback Statute can result in significant criminal fines, exclusion from participation in Medicare and
Medicaid and follow-on civil litigation, among other things, for both entities and individuals.
Other federal healthcare fraud-related laws also provide criminal liability for violations. The Criminal Healthcare Fraud
statute, 18 U.S.C. § 1347 prohibits knowingly and willfully executing a scheme to defraud any healthcare benefit program,
including private third-party payors. Federal 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.
The civil False Claims Act and similar state laws impose liability on any person or entity who, among other things,
knowingly presents, or causes to be presented, a false or fraudulent claim for payment by a federal healthcare program. The
qui tam provisions of the False Claims Act and similar state laws allow a private individual to bring civil actions on behalf
of the federal or state government and to share in any monetary recovery. The Federal Physician Payments Sunshine Act
and similar state laws impose reporting requirements for various types of payments to physicians, other licensed healthcare
practitioners and teaching hospitals. Failure to comply with required reporting requirements under these laws could subject
manufacturers and others to substantial civil monetary penalties. In addition, government entities and private litigants have
asserted claims under state consumer protection statutes against pharmaceutical and medical device companies for alleged
false or misleading statements in connection with the marketing, promotion and/or sale of pharmaceutical and medical
device products, including state investigations and litigation by certain government entities regarding our marketing of
opioid products.
The federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) created additional federal criminal
statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare
benefit program or obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money or
property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payor (e.g., public
or private) and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or
making any materially false statements in connection with the delivery of, or payment for, healthcare benefits, items or
services relating to healthcare matters. Like the AKS, the Patient Protection and Affordable Care Act (the “ACA”)
amended the intent standard for certain healthcare fraud statutes under HIPAA such that a person or entity no longer needs
to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation.
HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (“HITECH”)
and their respective implementing regulations, also impose requirements on certain covered healthcare providers, health
plans, and healthcare clearinghouses as well as their respective business associates that perform services for them that
involve the creation, use, receipt, maintenance or disclosure of individually identifiable health information, relating to the
privacy, security and transmission of individually identifiable health information. HITECH also created four new tiers of
civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates,
and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce
HIPAA and seek attorneys’ fees and costs associated with pursuing federal civil actions.
The federal Physician Payments Sunshine Act, created under the ACA, and its implementing regulations, requires
manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid
or the Children’s Health Insurance Program to report annually to the CMS under the Open Payments Program, information
related to payments or other transfers of value made to physicians (defined to include doctors, dentists, optometrists,
podiatrists and chiropractors), to certain non-physician providers such as physician assistants and nurse
15
practitioners, and to teaching hospitals, as well as ownership and investment interests held by physicians and their
immediate family members.
Federal price reporting laws require manufacturers to calculate and report complex pricing metrics to government
programs, where such reported prices may be used in the calculation of reimbursement and/or discounts on approved
products. 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 healthcare providers and other potential referral sources; state laws that
require drug manufacturers to file reports with states regarding pricing and marketing information, such as the tracking and
reporting of gifts, compensation and other remuneration and items of value provided to healthcare professionals and
entities; state and 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.
Because of the breadth of these laws and the narrowness of the statutory exceptions and regulatory safe harbors available, it
is possible that some of a pharmaceutical manufacturer’s business activities could be subject to challenge under one or
more of such laws. 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 any such actions are instituted against a pharmaceutical manufacturer,
and it is not successful in defending itself or asserting its rights, those actions could have a significant impact on its
business, including the imposition of significant civil, criminal and administrative penalties, damages, disgorgement,
imprisonment, monetary fines, possible exclusion from participation in Medicare, Medicaid and other federal healthcare
programs, reporting obligations and oversight if we become subject to integrity and oversight agreements to resolve
allegations of non-compliance, contractual damages, reputational harm, diminished profits and future earnings, and
curtailment of operations, any of which could adversely affect a pharmaceutical manufacturer’s ability to operate its
business and the results of operations. In addition, commercialization of any drug product outside the U.S. will also likely
be subject to foreign equivalents of the healthcare laws mentioned above, among other foreign laws.
Third-Party Payor Coverage and Reimbursement
The commercial success of our products will depend, in part, upon the availability of coverage and adequate
reimbursement from third-party payors at the federal, state and private levels. Third-party payors include governmental
programs such as Medicare or Medicaid, private insurance plans and managed care plans. These third-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-party payors have attempted to control costs by limiting coverage
through the use of formularies and other cost-containment mechanisms and the amount of reimbursement for particular
procedures or drug treatments. In addition, some third-party payors also require preapproval of coverage for new or
innovative devices or drug therapies before they will reimburse healthcare providers who prescribe such therapies.
The cost of pharmaceuticals and devices continues to generate substantial governmental and third-party payor interest. We
expect that the pharmaceutical industry will continue to experience pricing pressures due to the trend toward managed
healthcare, the increasing influence of managed care organizations and additional legislative proposals. As a result, our
operations and business could be adversely affected by current and future third-party payor policies as well as healthcare
legislative reforms.
While we cannot predict whether any proposed cost-containment measures will be adopted or otherwise implemented in
the future, these requirements or any announcement or adoption of such proposals could have a material adverse effect on
our ability to obtain adequate prices for our products and any other products we may seek to commercialize, and to operate
profitably.
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Healthcare Reform
In the United States, 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-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. 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-governmental payors.
In March 2010, the Affordable Care Act was enacted, which significantly changed the way healthcare is financed by both
governmental and private insurers. Among the provisions of the Affordable Care Act of importance to the pharmaceutical
and biotechnology industry are the following:
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an annual, non-deductible fee on any entity that manufactures or imports certain branded prescription drugs and
biologic agents, apportioned among these entities according to their market share in certain government healthcare
programs;
an increase in the rebates a manufacturer must pay under the Medicaid Drug Rebate Program to 23.1% and 13%
of the average manufacturer price for branded and generic drugs, respectively;
a Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% (later
amended to 70%) point-of-sale discounts to negotiated prices of applicable brand drugs to eligible beneficiaries
during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under
Medicare Part D;
extension of manufacturers’ Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled
in Medicaid managed care organizations;
expansion of eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid
coverage to additional individuals and by adding new mandatory eligibility categories for certain individuals with
income at or below 133% of the Federal Poverty Level, thereby potentially increasing manufacturers’ Medicaid
rebate liability;
expansion of the entities eligible for discounts under the Public Health Service pharmaceutical pricing program;
a licensure framework for follow-on biologic products;
a Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical
effectiveness research, along with funding for such research;
a requirement to annually report drug samples that manufacturers and distributors provide to physicians; and
establishment of a Center for Medicare Innovation at CMS to test innovative payment and service delivery models
to lower Medicare and Medicaid spending, potentially including prescription drug spending.
The Affordable Care Act has been subject to challenges in the courts. On June 17, 2021, in an appeal from a lower court
decision holding that the individual mandate under the Affordable Care Act is unconstitutional, the Supreme Court ruled
that the plaintiffs lacked standing to challenge the law as they had not alleged personal injury traceable to the allegedly
unlawful conduct. As a result, the Supreme Court did not rule on the constitutionality of the Affordable Care Act or any of
its provisions.
In addition, other legislative changes have been proposed and adopted since the Affordable Care Act was enacted. The
Budget Control Act of 2011 and subsequent legislation has resulted in reductions to Medicare payments to providers of up
to 2% per fiscal year, which will remain in effect through 2030 unless additional action is taken by Congress.
17
The American Taxpayer Relief Act of 2012 reduced Medicare payments to several providers and increased the statute of
limitations period for the government to recover overpayments to providers from three to five years. These laws may result
in additional reductions in Medicare and other healthcare funding, which could have a material adverse effect on our
customers and, accordingly, our financial operations. The American Rescue Plan Act of 2021 eliminates the statutory
Medicaid drug rebate cap, currently set at 100% of a drug’s average manufacturer price, for single source and innovator
multiple source drugs, beginning January 1, 2024. Removal of the drug rebate cap can result in paying rebate payments to
Medicaid that are higher than the sale price of the drug.
The 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 time. The implementation of the IRA
is currently subject to ongoing litigation that challenges the constitutionality of the IRA’s Medicare drug price negotiation
program. The IRA could have the effect of reducing the prices we can charge and reimbursement we receive for our
products, thereby reducing our profitability, and could have a material adverse effect on our financial condition, results of
operations and growth prospects. The effect of the IRA on our business and the pharmaceutical industry in general is not
yet known.
Our Environmental, Social, and Governance (“ESG”) Initiatives
Our commitment to serving as a responsible corporate citizen is rooted in our longstanding history of advancing our
mission, executing our commercial strategy, governing our business to drive efficiency and value creation, and supporting
our communities. We have prioritized corporate governance and risk mitigation; employee development and culture; our
environmental footprint; and giving back to our communities. As a reflection of this commitment, our annual Corporate
Scorecard has included metrics relating to our performance relative to specific ESG initiatives.
In February 2024, we published our annual ESG report on our corporate website highlighting our ESG accomplishments to
date. The information contained in our ESG report is not a part of, nor is it incorporated by reference into, this Form 10-K.
Human Capital Management
Collegium Culture and Employee Engagement
Our employees are foundational to our current and future success, and we believe that their engagement and commitment
are among our most valuable assets. As we seek to build and sustain a challenging, inspiring, and inclusive environment for
our employees, we have focused on talent acquisition and retention; employee training and development; diversity and
inclusion; and employee health and safety.
At Collegium, we recognize that we have a responsibility to hold ourselves to the highest standard of business and
professional ethics. 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: Uphold Integrity, Embrace Differences, Encourage Expression, and Be Accountable.
We prioritize transparency, recognition, and collaboration to support our team’s engagement. We facilitate transparent
communications through various channels, such as quarterly all-employee meetings, small-group employee conversations
with our Chief Executive Officer, and periodic employee engagement surveys.
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Talent Acquisition and 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 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.
Employee Training and Development
We believe career development begins with good conversations between employees and their managers that ensure regular
feedback, and we have implemented tools and annual processes that allow all employees in conjunction with their
managers to explore possibilities and drive development action. Our comprehensive performance review process ensures
our employees are on track with their development throughout the year.
Diversity, Equity, and Inclusion
We are committed to fostering diversity, equity, and inclusion (“DEI”) in our workplace. We are unwavering in our
commitment to treat our colleagues fairly, and we are open-minded and inclusive in our engagements with one other, our
partners, and customers. We believe that when people feel appreciated and included, they are more creative, innovative,
and successful, which in turn improves our business and performance and enhances shareholder value. We are committed
to employing people whose diverse backgrounds contribute to innovation and allow us to approach the complex issues that
face our industry from many different perspectives.
We are executing our multi-year DEI strategic plan that strives to integrate DEI with our overall business goals by focusing
on topics such as developing, retaining, and attracting talent; creating and sustaining a work environment where all
employees feel valued and engaged; and developing a strong reputation and strategic alliance partnerships with the
communities we serve.
As of December 2023, we had a total of 197 employees with representation with respect to gender and self-reported race
and ethnicity as follows:
Ethnicity
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)
Total
Gender
Female
Male
Total
#
15
12
5
3
3
159
197
#
98
99
197
%
%
7.6%
6.1%
2.5%
1.5%
1.5%
80.8%
100%
49.7%
50.3%
100%
As in everything we do, we are committed to continuous improvement in this area. While we are proud of the diversity of
backgrounds and identities that our workforce exhibits, we will make the necessary investments of time, resources, and
engagement to make sustained improvements in this area.
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Employee Health and 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 all employees and their families with access to a variety
of innovative, flexible, and convenient health and wellness programs.
Our Executive Officers
The following table lists the positions, names and ages of our executive officers as of February 22, 2024:
Name
Joseph Ciaffoni
Colleen Tupper
Scott Dreyer
Shirley Kuhlmann
Thomas Smith
Age
52
48
51
40
63
Position(s)
Director, President and Chief Executive Officer
Executive Vice President and Chief Financial Officer
Executive Vice President and Chief Commercial Officer
Executive Vice President, General Counsel and Chief Administrative Officer
Executive Vice President and Chief Medical Officer
Joseph Ciaffoni, Director, President and Chief Executive Officer. Mr. Ciaffoni was appointed as our President and Chief
Executive Officer of Collegium Pharmaceutical in July 2018. Mr. Ciaffoni joined us in May 2017 as Executive Vice
President and Chief Operating Officer. Prior to joining us, he served as President, U.S. Branded Pharmaceuticals of Endo
International plc. Before that, Mr. Ciaffoni held various positions of increasing responsibility at Biogen, including Senior
Vice President, Global Specialty Medicines Group, Senior Vice President, U.S. Commercial and Vice President, U.S.
Neurology Field Operations and Marketing. Prior to joining Biogen, he was Executive Vice President and Chief Operating
Officer of Shionogi Inc. and President of Shionogi Pharmaceuticals. Mr. Ciaffoni also previously served as Vice President,
Sales for Schering-Plough (now Merck) and held several commercial leadership roles at Sanofi-Synthelabo (now Sanofi)
and Novartis. Mr. Ciaffoni received a B.A. in Communications and an M.B.A. from Rutgers.
Colleen Tupper, Executive Vice President and Chief Financial Officer. Ms. Tupper joined us in May 2021 as Executive
Vice President and Chief Financial Officer. Prior to joining us, 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). Ms. Tupper received a B.S. in Accounting from Franklin Pierce University.
Scott Dreyer, Executive Vice President and Chief Commercial Officer. Mr. Dreyer was appointed as our Executive Vice
President and Chief Commercial Officer in July 2018. Mr. Dreyer joined us in January 2018 as Senior Vice President of
Sales, Marketing, Commercial Capabilities and Training. He has over 25 years of commercial experience across sales,
marketing, commercial operations and strategic planning, all within the biopharma industry. Most recently, Mr. Dreyer was
Senior Vice President, Marketing and Commercial Operations for The Medicines Company. Prior to joining The Medicines
Company, he was Vice President and Chief Marketing Officer-U.S. at Biogen. Prior to Biogen, Mr. Dreyer held various
commercial leadership positions of increasing responsibility at Merck & Co, including Vice President-U.S. Hospital and
Oncology Sales and Commercial Operations, Vice President-U.S. Primary Care Sales, Executive Director U.S. Regional
Marketing Leader – Neuroscience, Executive Director Customer Marketing and Solutions, Sr. Director of Strategic
Planning and Director of Cardiovascular Marketing. Mr. Dreyer received a B.S. in Biology from Messiah College.
Shirley Kuhlmann, Executive Vice President, General Counsel and Chief Administrative Officer. Ms. Kuhlmann joined
Collegium Pharmaceutical in March 2018 as Executive Vice President, General Counsel and Secretary and has also served
as Chief Administrative Officer since March 2022. Prior to joining Collegium, Ms. Kuhlmann was an attorney in the
Health Sciences Group of Pepper Hamilton LLP, a law firm headquartered in Philadelphia, Pennsylvania. Ms. Kuhlmann
began her career at Pepper Hamilton in 2007 as an Associate and was elected a Partner of the firm in 2016. While with
Pepper Hamilton, she advised private and public companies on a range of transactional matters, including securities
offerings, mergers and acquisitions and other financing transactions. Ms. Kuhlmann received a B.A. in Economics and
Political Science from Columbia University and a J.D. from the Emory University School of Law.
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Thomas Smith, M.D., Executive Vice President and Chief Medical 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 to July 2018, Ameritox and Mallinckrodt
Pharmaceuticals. Prior to these, Dr. 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. Smith earned his M.D. from the
Indiana University School of Medicine and a B.S. from Purdue University.
Our Corporate Information
We are headquartered in Stoughton, Massachusetts and our common stock trades on the NASDAQ Global Select Market
(“NASDAQ”) under the trading symbol “COLL.”
Our predecessor was incorporated in Delaware in April 2002 under the name Collegium Pharmaceuticals, Inc. 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.
Available Information
We maintain a website at www.collegiumpharma.com. We make available, free of charge on our website, our annual
reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and all amendments to those reports
filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended (“Exchange
Act”), as soon as reasonably practicable after we electronically file those reports with, or furnish them to, the Securities and
Exchange Commission (“SEC”). We also make available, free of charge on our website, the reports filed with the SEC by
our officers, directors and 10% shareholders pursuant to Section 16 under the Exchange Act as soon as reasonably
practicable after copies of those filings are provided to us by those persons. 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.
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Item 1A. Risk Factors
Investing in our common stock involves a high degree of risk. Investors 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 investors could lose all or part of their 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:
● Our ability to maintain profitability is dependent upon our ability to continue successfully commercializing our
products and any products we may acquire in the future;
● We have substantial outstanding indebtedness, which may adversely affect our business, financial condition and
results of operations;
● Adverse developments affecting the financial services industry could adversely affect our business, financial
condition, or results of operations;
● If we cannot continue successfully commercializing our products and any products that we may acquire in the
future, our business, financial condition and results of operations may be materially adversely affected and the
price of our common stock may decline;
● Despite receiving approval by the FDA, additional data may emerge that could change the FDA’s position on the
product labeling of any of our products, including our abuse-deterrent claims with respect to Xtampza ER, and
our ability to market our products successfully may be adversely affected;
● Xtampza ER, the Nucynta Products, and Belbuca are subject to mandatory REMS programs, which could
increase the cost, burden and liability associated with the commercialization of these products;
● Failure to comply with ongoing governmental regulations for marketing our products, and in particular any
failure to promote Xtampza ER’s abuse deterrent labeling in compliance with FDA regulations, could delay or
inhibit our ability to generate revenues from their sale and could also expose us to claims or other sanctions;
● Unfavorable outcomes in intellectual property litigation could be costly and potentially limit our ability to
commercialize our products;
● If we are unable to obtain or maintain intellectual property rights for our technologies, products or any products
we may acquire, we may lose valuable assets or be unable to compete effectively in our market;
● We have been, and may continue to be, forced to litigate to enforce or defend our intellectual property, which
could be expensive, time consuming and unsuccessful, and result in the loss of valuable assets;
● Obtaining and maintaining our patent protection depends on compliance with various procedural, document
submissions, fee payment and other requirements imposed by governmental patent agencies, and our patent
protection could be reduced or eliminated for non-compliance with these requirements;
● If we are unable to utilize our own sales and marketing capabilities successfully or enter into strategic alliances
with marketing collaborators, we may not continue to be successful in commercializing our products and may be
unable to generate sufficient product revenue;
● If the medical community, patients, and healthcare payors do not accept and use our products, we will not achieve
sufficient product revenues and our business will suffer;
● Our products contain controlled substances, the manufacture, use, sale, importation, exportation and distribution
of which are subject to regulation by state and federal law enforcement and other regulatory agencies;
● Current and future legislation may increase the difficulty and cost for us to continue to commercialize our
products and may reduce the prices we are able to obtain for our products;
● Our products may become subject to unfavorable pricing regulations or third-party coverage and reimbursement
policies, which could have a material adverse effect on our business. Such pricing regulations may address the
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rebates that manufacturers offer to pharmaceutical benefit managers, or the discounts that manufacturers provide
others within the pharmaceutical distribution chain;
● Social issues around the abuse of opioids, including law enforcement concerns over diversion of opioids and
regulatory and enforcement efforts to combat abuse, could decrease the potential market for our products and may
adversely impact external investor perceptions of our business;
● If the FDA or other applicable regulatory authorities approve generic products with abuse deterrent claims that
compete with our products, our sales could decline;
● If the third-party manufacturers of our products fail to devote sufficient time and resources to these products, or
their performance is substandard, and/or we encounter challenges with our dedicated manufacturing suite at our
third-party manufacturer’s site for the manufacturing of Xtampza ER, our costs may be higher than expected and
could have a material adverse effect on our business;
● Because we currently rely on a sole supplier or limited number of suppliers to manufacture the active
pharmaceutical ingredient of our products, any production problems with any of these suppliers could have a
material adverse effect on us;
● We depend on wholesale pharmaceutical distributors for retail distribution of our products; if we lose any of our
significant wholesale pharmaceutical distributors or their distribution network is disrupted, our financial condition
and results of operations may be adversely affected;
● Our products could be subject to post-marketing requirements, which requirements may, in some cases, not be
capable of timely or satisfactory completion without participation in consortia over which we have limited
control;
● We may not realize all of the anticipated benefits from future acquisitions, and we may be unable to successfully
integrate future acquisitions;
● Our business may be adversely affected by certain events or circumstances outside our control, including
macroeconomic conditions and geopolitical turmoil;
● Litigation or regulatory action regarding opioid medications could negatively affect our business;
● We face substantial competition from other biotechnology and pharmaceutical companies, which may result in
others discovering, developing or commercializing products more successfully than we do;
● Commercial sales of our products may expose us to expensive product liability claims, and we may not be able to
maintain product liability insurance on reasonable terms or at all;
● Our relationships with customers and payors are subject to applicable anti-kickback, fraud and abuse,
transparency, and other healthcare laws and regulations, which could expose us to criminal sanctions, civil
penalties, exclusion from government healthcare programs, contractual damages, reputational harm,
administrative burdens, and diminished profits and future earnings; and
● The price of our common stock may be volatile and you may lose all or part of your investment.
Risks Related to Our Financial Position and Capital Needs
Our ability to maintain profitability is dependent upon our ability to continue successfully commercializing our products
and any products that we may acquire in the future. Our failure to do so successfully could impair our growth strategy
and plans and could have a material adverse effect on our business, financial position, and operating results.
Our ability to maintain profitability depends upon our ability to realize the full commercial potential of our products and to
commercialize successfully any other products that we may in-license or acquire in the future. Our ability to generate
revenue from our current or future products depends on a number of factors, including our ability to:
● realize a commercially viable price for our products;
● manufacture commercial quantities of our products at acceptable cost levels;
● sustain a commercial organization capable of sales, marketing and distribution for the products we sell;
● obtain coverage and adequate reimbursement from third parties, including government payors;
● acquire new products, or develop new indications or line extensions for existing products, in the event that
revenues from our existing products are impacted by price controls, loss of intellectual property exclusivity or
competition; and
● comply with existing and changing laws and regulations that apply to the pharmaceutical industry, including
opioid manufacturers, and to our products specifically, including FDA post-marketing requirements.
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If we fail to maintain profitability on a continuing basis, then we may be unable to continue our operations at planned
levels and be forced to reduce our operations.
Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.
As of December 31, 2023, we had a U.S. federal net operating loss (“NOL”) carryforward of approximately $137.5 million
and state NOL carryovers of approximately $202.4 million. The U.S. federal and state NOL carryforwards expire at
various dates through 2037. Federal NOLs and certain state NOLs incurred in 2018 and onward have an indefinite
expiration under the Tax Cuts and Jobs Act of 2017 and applicable state statutes. We also had U.S. federal tax credits of
approximately $1.0 million, and state tax credits of approximately $0.7 million. These tax attributes are generally subject to
a limited carryover/carryback period and are also subject to the annual limitations that may be imposed under Section 382
of the Internal Revenue Code of 1986, as amended (“IRC 382”).
In 2021, we completed a study to assess the impact of ownership changes, if any, on our ability to use our NOL and tax
credit carryovers as defined under IRC 382 (the “IRC 382 Study”). As a result of the study, we concluded that there were
ownership changes that occurred during the years 2006, 2012 and 2015 that would be subject to IRC 382 limitations. These
IRC 382 annual limitations may limit our ability to use pre-ownership change federal NOL carryovers and pre-ownership
change federal tax credit carryovers, which may potentially limit our ability to reduce our future federal income tax
liability by using these losses.
As part of the BDSI acquisition, we acquired an estimated $234.7 million of federal NOL carryovers which are generally
subject to a limited carryover/carryback period and are also subject to the annual limitations that may be imposed under
IRC 382. We performed an IRC 382 study following the BDSI Acquisition in 2022 and concluded that there were
ownership changes that occurred during the years 2006 and 2022 that would be subject to IRC 382 limitations. These IRC
382 annual limitations may limit our ability to use pre-ownership change federal NOL carryovers and pre-ownership
change federal tax credit carryovers, which may potentially limit our ability to reduce our future federal income tax
liability by using these losses. As of December 31, 2023, remaining net operating losses of $124.3 million are subject to
limitation. Refer to Note 18, Income Taxes, to our consolidated financial statements included in Part IV of this Annual
Report on Form 10-K for more information.
We have substantial outstanding indebtedness, which may adversely affect our business, financial condition and results
of operations.
In March 2022, we entered into a $650.0 million secured term loan (the “2022 Term Loan”) pursuant to our Amended and
Restated Loan Agreement with BioPharma Credit PLC, as collateral agent and lender, and BioPharma Credit Investments
V (Master) LP, as lender (as amended from time to time, the “2022 Loan Agreement”), of which $412.5 million in
principal was outstanding as of December 31, 2023. In addition, we have $26.4 million in 2.625% Convertible Senior
Notes due in 2026 (the “2026 Convertible Notes”) and $241.5 million in 2.875% Convertible Senior Notes due 2029 (the
“2029 Convertible Notes” and, together with the 2026 Convertible Notes, the “Convertible Notes”). We may also incur
additional indebtedness to meet future financing needs. Our existing and future levels of indebtedness could have
significant negative consequences for our security holders and our business, results of operations and financial condition
by, and among other things:
● requiring the dedication of a substantial portion of our cash flows from operations to service our indebtedness,
which will reduce the amount of cash available for operations, working capital, capital expenditures, expansion,
acquisitions or general corporate or other purposes;
● limiting our ability to obtain additional financing;
● limiting our flexibility to plan for, or react to, changes in our business;
● exposing us to the risk of increased interest rates as certain of our borrowings, including the 2022 Term Loan, are
at variable rates of interest;
● diluting the interests of our existing shareholders as a result of issuing shares of our common stock upon
conversion of the Convertible Notes;
● placing us at a possible competitive disadvantage with competitors that are less leveraged than we are or have
better access to capital; and
● increasing our vulnerability to downturns in our business, our industry or the economy in general.
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Holders of our Convertible Notes, subject to a limited exception described in the notes, may require us to repurchase their
notes following a fundamental change at a cash repurchase price generally equal to the principal amount of the notes to be
repurchased, plus accrued and unpaid interest, if any. In addition, upon conversion, we will satisfy part or all of our
conversion obligation in cash unless we elect to settle conversions solely in shares of our common stock. We may not have
enough available cash or be able to obtain financing at the time we are required to repurchase the notes or pay the cash
amounts due upon conversion. Applicable law, regulatory authorities and the agreements governing our other indebtedness
may restrict our ability to repurchase the notes or pay the cash amounts due upon conversion, and any failure by us to
repurchase notes or to pay the cash amounts due upon the conversion when required would constitute a default under the
indenture.
Additionally, the indentures governing the Convertible Notes and our 2022 Loan Agreement contain certain covenants and
obligations applicable to us, including, without limitation, covenants that limit our ability to incur additional indebtedness
or liens, make acquisitions or other investments or dispose of assets outside the ordinary course of business, which could
limit our ability to capitalize on business opportunities that may arise or otherwise place us at a competitive disadvantage
relative to our competitors.
Failure to comply with covenants in the indentures governing the Convertible Notes or in the 2022 Loan Agreement would
constitute an event of default under those instruments, notwithstanding our ability to meet our debt service obligations. A
default under the indentures or a fundamental change could also result in a default under one or more of the agreements
governing our other indebtedness, which may result in that other indebtedness becoming immediately payable in full. In
such event, we may not have sufficient funds to satisfy all amounts that would become due. The 2022 Loan Agreement
includes various customary remedies for the lenders following an event of default, including the acceleration of repayment
of outstanding amounts under the 2022 Loan Agreement and execution upon the collateral securing obligations under the
2022 Loan Agreement. In addition, because our assets are pledged as a security under the 2022 Loan Agreement, if we are
not able to cure any default or repay outstanding borrowings, our assets would be subject to the risk of foreclosure by our
lenders.
Further, amounts outstanding under our 2022 Loan Agreement historically bore interest at a rate based on the London
Interbank Offered Rate (“LIBOR”), and, effective July 1, 2023, bears interest at a rate based on the Secured Overnight
Financing Rate (“SOFR”) subject to a SOFR floor of 1.2%. We have not hedged our interest rate exposure with respect to
our floating rate debt. Accordingly, our interest expense for any period will fluctuate based on SOFR and other variable
interest rates, as applicable. To the extent the interest rates applicable to our floating rate debt increase, our interest expense
will increase, in which event we may have difficulties making interest payments and funding our other fixed costs, and our
available cash flow for general corporate requirements may be adversely affected.
Adverse developments affecting the financial services industry, including events or concerns involving liquidity, defaults
or non-performance by financial institutions or transactional counterparties, could adversely affect our business,
financial condition, or results of operations.
Events involving limited liquidity, defaults, non-performance or other adverse developments that affect financial
institutions, transactional counterparties or other companies in the financial services industry or the financial services
industry generally, or concerns or rumors about any events of these kinds or other similar risks, have in the past and may in
the future lead to market-wide liquidity problems. For example, in early 2023, several financial institutions closed and were
taken into receivership by the Federal Deposit Insurance Corporation (“FDIC”). Although we assess our banking and
customer relationships as we believe necessary or appropriate, our access to funding sources and other credit arrangements
in amounts adequate to finance or capitalize our current and projected future business operations could be significantly
impaired by factors that affect us, the financial services industry or economy in general. Further, investor concerns
regarding domestic or international financial systems could result in less favorable commercial financing terms, including
higher interest rates or costs and tighter financial and operating covenants, or systemic limitations on access to credit and
liquidity sources, thereby making it more difficult for us to acquire financing on acceptable terms or at all. Any decline in
available funding or access to cash and liquidity resources could, among other risks, adversely impact our ability to meet
our financial obligations, which could have material adverse impacts on our liquidity and our business, financial condition,
or results of operations.
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Risks Related to our Products
If we cannot continue successfully commercializing our products and any products that we may acquire in the future,
our business, financial condition and results of operations may be materially adversely affected and the price of our
common stock may decline.
Our business and future success are substantially dependent on our ability to continue successfully commercializing our
products, including Xtampza ER, the Nucynta Products, Belbuca and Symproic, and any products that we may acquire in
the future.
Our ability to continue successfully commercializing our products will depend on many factors, including but not
limited to:
● our ability to manufacture commercial quantities of our products at reasonable cost and with sufficient speed to
meet commercial demand;
● our ability to execute sales and marketing strategies successfully and continually;
● our success in educating physicians, patients and caregivers about the benefits, administration, use and coverage
of our products;
● with respect to Xtampza ER, the perceived availability and advantages, relative cost, relative safety and relative
efficacy of other abuse-deterrent products and treatments with similar indications;
● our ability to defend successfully any challenges to our intellectual property or suits asserting patent infringement
relating to our products;
● the availability and quality of coverage and adequate reimbursement for our products;
● a continued acceptable safety profile of our products;
● our ability to acquire new products, or develop new indications or line extensions for existing products, in the
event that revenues from our existing products are impacted by price controls, loss of intellectual property
exclusivity or competition; and
● our ability to comply with applicable legal and regulatory requirements, including any additional manufacturing
or packaging requirements that may become applicable to certain opioid products.
Many of these matters are beyond our control and are subject to other risks described elsewhere in this “Risk Factors”
section. Accordingly, we cannot assure you that we will be able to continue successfully commercializing or to generate
sufficient revenue from our products. If we cannot do so, or are significantly delayed in doing so, our business will be
materially harmed.
Despite receiving approval by the FDA, additional data may emerge that could change the FDA’s position on the
product labeling of any of our products, including our abuse-deterrent claims with respect to Xtampza ER, and our
ability to market our products successfully may be adversely affected.
Xtampza ER was approved with label language describing abuse-deterrent properties of the formulation with respect to the
nasal and IV routes of abuse, consistent with Guidance for Industry, “Abuse-Deterrent Opioids- Evaluation and Labeling.”
In November 2017, the FDA approved a 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), results from an oral human abuse potential study and the addition of
an oral abuse deterrent claim.
The FDA can require changes to the product labeling for any of our products at any time which can impact our ability to
generate product sales. In particular, if the FDA determines that our post-marketing data for Xtampza ER does not
demonstrate that the abuse-deterrent properties result in reduction of abuse, or demonstrates a shift to routes of abuse that
present a greater risk, the FDA may find that product labeling revisions are needed, and potentially require the removal of
our abuse-deterrence claims, which would have a material adverse effect on our ability to continue successfully
commercializing Xtampza ER.
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Our opioid products are subject to mandatory REMS programs, which could increase the cost, burden and liability
associated with the commercialization of these products.
The FDA has imposed a class-wide REMS on all IR, ER and long-acting opioid drug products (known as the Opioid
Analgesic REMS). The FDA continually evaluates whether the REMS program is meeting its goal of ensuring that the
benefit of these drugs continue to outweigh their risks, and whether the goals or elements of the program should be
modified. As opioids, Xtampza ER, the Nucynta Products and Belbuca are subject to the Opioid Analgesic REMS.
Any modification of the Opioid Analgesic REMS by the FDA to impose additional or more burdensome requirements
could increase the costs associated with marketing these products and/or reduce the willingness of healthcare providers to
prescribe these products, which would have a material adverse effect on our ability to continue to successfully
commercialize and generate sufficient revenue from these products.
Failure to comply with ongoing governmental regulations for marketing our products, and in particular any failure to
promote Xtampza ER’s abuse deterrent labeling in compliance with FDA regulations, could delay or inhibit our ability
to generate revenues from their sale and could also expose us to claims or other sanctions.
In addition to scrutiny by the FDA, advertising and promotion of any pharmaceutical product marketed in the United States
is heavily scrutinized by, among others, the Department of Justice, the Office of Inspector General for the U.S. Department
of Health and Human Services, state attorneys general, members of Congress and the public. Violations, including
promotion of our products for unapproved or off-label uses, are subject to enforcement letters, inquiries and investigations,
and civil and criminal sanctions by government agencies.
In particular, Xtampza ER has FDA-approved product labeling that describes its abuse deterrent features, which allows us
to promote those features and differentiate Xtampza ER from other opioid products containing the same active
pharmaceutical ingredients. Because the FDA closely regulates promotional materials and other promotional activities,
even though the FDA-approved product labeling includes a description of the abuse deterrent characteristics of Xtampza
ER, the FDA may object to our marketing claims and product advertising campaigns.
Engaging in off-label promotion of our products, including Xtampza ER, could subject us to false claims liability under
federal and state statutes, and other litigation and/or investigations, and could lead to the issuance of warning letters or
untitled letters, suspension or withdrawal of our products from the market, recalls, fines, disgorgement money, operating
restrictions, injunctions, and civil or criminal prosecution. Any of these consequences would harm the commercial success
of our products, including Xtampza ER.
Further, discovery of serious and unanticipated adverse events associated with the product; the emergence of other
problems with the product, manufacturer or facility; or our failure to make required regulatory submissions may result in
adverse regulatory actions, including withdrawal of the product from the market or the requirement to add or strengthen
label warnings about the product. The failure to obtain or maintain requisite governmental approvals or the imposition of
additional or stronger warnings could delay or preclude us from realizing the full commercial potential of our products.
Risks Related to Intellectual Property
Unfavorable outcomes in intellectual property litigation could be costly and potentially limit our ability to commercialize
our products.
Our commercial success depends upon our ability to commercialize products without infringing the intellectual property
rights of others. Our current or future products, or any uses of them, may now or in the future infringe third-party patents or
other intellectual property rights. We cannot currently determine the ultimate scope and validity of patents which may be
granted to third parties in the future or which patents might be asserted to be infringed by the manufacture, use and sale of
our products.
If we are found to infringe a third party’s intellectual property rights, we could be required to obtain a license from such
third party to continue developing or commercializing our products and technology. However, we may not be able to obtain
any required license on commercially reasonable terms or at all. Even if we are able to obtain a license, it may be non-
exclusive, thereby giving our competitors access to the same technologies licensed to us. We could be forced, including by
court order, to cease commercializing the infringing technology or product. In addition, in any such
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proceeding or litigation, we could be found liable for monetary damages, including treble damages and attorneys’ fees, if
we are found to have willfully infringed a patent. A finding of infringement could prevent us from commercializing our
products or force us to cease some of our business operations.
Any litigation, including any interference or derivation proceedings to determine priority of inventions, oppositions or
other post-grant review proceedings to patents in the United States, or litigation against our collaborators may be costly and
time consuming and could have a material adverse effect on our operating results, our ability to raise capital needed to
commercialize products and our overall financial condition. We expect that litigation may be necessary in some instances
to determine the validity and scope of our proprietary rights. Litigation may be necessary in other instances to determine
the validity, scope or non-infringement of certain patent rights claimed by third parties to be pertinent to the manufacture,
use or sale of our products. Ultimately, the outcome of such litigation, including our pending litigation with Purdue, could
compromise the validity and scope of our patents or other proprietary rights or hinder our ability to manufacture and
market our products.
If we are unable to obtain or maintain intellectual property rights for our technologies, products or any products we
may acquire, we may lose valuable assets or be unable to compete effectively in our market.
We depend on our ability to protect our proprietary technology. We rely on patent and trademark laws, unpatented trade
secrets and know-how, and confidentiality, licensing and other agreements with employees and third parties, all of which
offer only limited protection. Our success depends in large part on our ability to obtain and maintain patent protection in
the United States with respect to our proprietary technology and products.
The steps we have taken to protect our proprietary rights may not be adequate to preclude misappropriation of our
proprietary information or infringement of our intellectual property rights in the United States. The rights already granted
under any of our currently issued patents and those that may be granted under future issued patents may not provide us
with the proprietary protection or competitive advantages we are seeking.
We have been, and may continue to be, forced to litigate to enforce or defend our intellectual property, which could be
expensive, time consuming and unsuccessful, and result in the loss of valuable assets.
We have been, and may continue to be, forced to litigate to enforce or defend our intellectual property rights against
infringement and unauthorized use by competitors, and to protect our trade secrets, including in connection with our
pending litigation against generic competitors that have filed Paragraph IV Certifications relating to certain of our
products. In so doing, we may place our intellectual property at risk of being invalidated, rendered unenforceable or limited
or narrowed in scope. This litigation is expensive and time consuming. Many of our current and potential competitors have
the ability to dedicate substantially greater resources to defend their intellectual property rights than we can.
Accordingly, despite our efforts, we may not be able to prevent third parties from infringing upon or misappropriating our
intellectual property. Litigation could result in substantial costs and diversion of management resources, which could have
a material adverse effect on our operating results, our ability to raise capital needed to commercialize products and our
overall financial condition. In addition, an adverse result in any litigation proceeding could put one or more of our patents
at risk of being invalidated, held unenforceable or interpreted narrowly.
If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be
harmed.
In addition to seeking patents for some of our technology and products, we rely on trade secrets, including unpatented
know-how, technology and other proprietary information, to maintain our competitive position. We seek to protect these
trade secrets, in part, by entering into non-disclosure and confidentiality agreements with parties who have access to them,
such as our employees, corporate collaborators, outside scientific collaborators, contract manufacturers, consultants,
advisors and other third parties. Despite these efforts, any of these parties may breach the agreements and disclose our
proprietary information, including our trade secrets, and we may not be able to obtain adequate remedies for such breaches.
Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive and time-
consuming, and the outcome is unpredictable. In addition, some courts in the United States may be less willing or
unwilling to protect trade secrets. If any of our trade secrets were to be lawfully obtained or independently developed by a
competitor, we would have no right to prevent such competitor, or those with whom they communicate, from using
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that technology or information to compete with us. If any of our trade secrets were to be disclosed or independently
developed, our competitive position would be harmed.
Obtaining and maintaining our patent protection depends on compliance with various procedural, document
submissions, fee payment and other requirements imposed by governmental patent agencies, and our patent protection
could be reduced or eliminated for non-compliance with these requirements.
The United States Patent and Trademark Office (“USPTO”) requires compliance with a number of procedural,
documentary, fee payment and other similar provisions during the patent application process. In addition, periodic
maintenance fees on issued patents are required to be paid to the USPTO in several stages over the lifetime of the patents.
While an inadvertent lapse can in many cases be cured by payment of a late fee or by other means in accordance with the
applicable rules, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent
application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. Non-compliance events that
could result in abandonment or lapse of a patent or patent application include, but are not limited to, failure to respond to
official actions within prescribed time limits, non-payment of fees, and failure to properly legalize and submit formal
documents. If we fail to maintain the patents and patent applications covering our products, our competitive position would
be adversely affected.
Risks Related to the Commercialization of Our Products
If we are unable to utilize our own sales and marketing capabilities successfully or enter into strategic alliances with
marketing collaborators, we may not continue to be successful in commercializing our products and may be unable to
generate sufficient product revenue.
Our commercial organization continues to evolve and we cannot guarantee that we will continue to be successful in
marketing our products. In addition, we compete with other pharmaceutical and biotechnology companies with extensive
and well-funded sales and marketing operations to recruit, hire, train and retain sales and marketing personnel. If we are
unable to continue to grow and maintain adequate sales, marketing and distribution capabilities, whether independently or
with third parties, including with respect to our recent acquisition of Belbuca and Symproic, we may not be able to
generate sufficient product revenue and may not remain profitable. Factors that may inhibit our efforts to continue
successfully commercializing our products in the United States include:
● our inability to recruit and retain adequate numbers of effective sales and marketing personnel;
● the inability of sales personnel to reach adequate numbers of physicians who may prescribe our products; and
● unforeseen costs and expenses associated with creating and maintaining an independent sales and marketing
organization.
If we are not successful in retaining sales and marketing personnel or in maintaining our sales and marketing infrastructure
or if we do not preserve strategic alliances with marketing collaborators, agreements with contract sales organizations or
collaboration arrangements, we will have difficulty in continuing to commercialize our products.
If the medical community, patients, and healthcare payors do not accept and use our products, we will not achieve
sufficient product revenues and our business will suffer.
Physicians and others in the medical community, patients, and healthcare payors may not continue to accept and use our
products, or accept and use any new products that we may acquire. Acceptance and use of our products will depend on a
number of factors including:
● approved indications, warnings and precautions language that may be less desirable than competitive products;
● perceptions of physicians and other healthcare community members of the safety and efficacy of our products;
● perceptions by members of the healthcare community, including physicians, about the relevance and efficacy of
our abuse deterrent technology;
● the availability of competitive products;
● the pricing and cost-effectiveness of our products relative to competing products;
● the potential and perceived advantages of our products over alternative treatments;
● the convenience and ease of administration to patients of our products;
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● actual and perceived availability and quality of coverage and reimbursement for our products from government or
other third-party payors;
● negative publicity related to our products or negative or positive publicity related to our competitors’ products;
● the prevalence and severity of adverse side effects;
● policy initiatives by FDA, HHS, DEA, or other federal or state agencies regarding opioids;
● our ability to comply with the Opioid Analgesic REMS; and
● the effectiveness of marketing and distribution efforts by us and any licensees and distributors.
If our products fail to have an adequate level of acceptance by the medical community, patients, or healthcare payors, we
will not be able to generate sufficient revenue to remain profitable. Since we expect to rely on sales generated by Xtampza
ER, the Nucynta Products, Belbuca, and Symproic for substantially all of our revenues for the foreseeable future, the
failure of these products to maintain market acceptance would harm our business prospects.
Some of our products contain controlled substances, and the manufacture, use, sale, importation, exportation and
distribution of which are subject to regulation by state and federal law enforcement and other regulatory agencies.
Some of our products contain controlled substances that are subject to state and federal laws and regulations regarding their
manufacture, use, sale, importation, exportation and distribution. Xtampza ER’s active ingredient, oxycodone, and the
Nucynta Products’ active ingredient, tapentadol, are both classified as Schedule II controlled substances under the CSA and
regulations of the DEA and the active ingredient in Belbuca, buprenorphine, is classified as a Schedule III controlled
substance. A number of states also independently regulate these drugs, including oxycodone, tapentadol
and buprenorphine, as controlled substances. We and our suppliers, manufacturers, contractors, customers and distributors
are required to obtain and maintain applicable registrations from state and federal law enforcement and regulatory agencies
and comply with state and federal laws and regulations regarding the manufacture, use, sale, importation, exportation and
distribution of controlled substances.
Furthermore, the amount of Schedule II substances that can be obtained for clinical trials and commercial distribution is
limited by the CSA and DEA regulations. For more information, refer to the section in our Annual Report entitled
“Business — Government Regulation — DEA and Opioid Regulation.” We may not be able to obtain sufficient quantities
of these controlled substances in order to meet commercial demand. If commercial demand for Xtampza ER, or any of our
other approved products, increases and we cannot meet such demand in a timely fashion because of our limited supply of
its active pharmaceutical ingredient (in the case of Xtampza ER, oxycodone) then physicians may perceive such product as
unavailable and may be less likely to prescribe it in the future.
In addition, controlled substances are also subject to regulations governing manufacturing, labeling, packaging, testing,
dispensing, production and procurement quotas (for Schedule I and II substances), recordkeeping, reporting, handling,
shipment and disposal. These regulations increase the personnel needs and the expense associated with commercialization
of our products that include controlled substances. The DEA and some states conduct periodic inspections of registered
establishments that handle controlled substances.
Failure to obtain and maintain required registrations or to comply with any applicable regulations could delay or preclude
us from manufacturing and commercializing our products that contain controlled substances and subject us to enforcement
action. The DEA may seek civil penalties, refuse to renew necessary registrations or initiate proceedings to revoke those
registrations. In some circumstances, violations could lead to criminal proceedings. Because of their restrictive nature,
these regulations could limit commercialization of our products containing controlled substances.
Current and future legislation may increase the difficulty and cost for us to continue to commercialize our products and
may reduce the prices we are able to obtain for our products.
In the United States, there have been a number of legislative and regulatory changes and proposed changes regarding the
healthcare system generally, and the manufacturing, distribution, and marketing of opioids in particular, that could affect
our ability to commercialize our products. For example, several states, including New York, have imposed taxes or fees on
the sale of opioids. Other states, and even the federal government, could impose similar taxes or fees, and such laws and
proposals can vary in the tax and fee amounts imposed and the means of calculation. Liabilities for taxes or assessments
under any such laws could have an adverse impact on our results of operations.
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California and several other states have enacted legislation related to prescription drug pricing transparency and it is
unclear the effect this legislation will have on our business. Laws intended to broaden access to health insurance, reduce or
constrain the growth of healthcare spending, enhance remedies against fraud and abuse, add new transparency
requirements for health care and health insurance industries, impose new taxes and fees on the health industry and impose
additional health policy reforms may continue the downward pressure on pharmaceutical pricing, especially under the
Medicare program, and may also increase our regulatory burdens and operating costs.
Legislative and regulatory proposals have been made to expand post-approval requirements and restrict sales and
promotional activities for pharmaceutical products. We cannot be sure whether additional legislative changes will be
enacted, or whether the FDA regulations, guidance or interpretations will be changed, or what the impact of such changes
on the marketing of our products may be. In addition, increased scrutiny by the U.S. Congress of the FDA’s approval
process may subject us to more stringent product labeling and post-marketing testing and other requirements.
Our products may become subject to unfavorable pricing regulations or third-party coverage and reimbursement
policies, which could have a material adverse effect on our business. Such pricing regulations may address the rebates
that manufacturers offer to pharmaceutical benefit managers, or the discounts that manufacturers provide others
within the pharmaceutical distribution chain.
The regulations that govern marketing approvals, pricing and reimbursement for new drug products can vary widely.
Current and future legislation may significantly change the approval requirements in ways that could involve additional
costs and cause delays in obtaining approvals. Pricing limitations may hinder our ability to recoup our investment in our
products.
Our ability to commercialize any product successfully will also depend in part on the extent to which coverage and
adequate reimbursement for these products and related treatments will be available from government health administration
authorities, private health insurers and other organizations. Government authorities and third-party payors determine which
medications they will cover and establish reimbursement levels and tiers of preference based on the perceived value and
innovation of a given product. A primary trend in the U.S. healthcare industry and elsewhere is cost containment.
Government authorities and other third-party payors have attempted to control costs by limiting coverage and the amount
of reimbursement for particular medications and establishing administrative hurdles that incentivize use of generic and/or
lower cost products first. Increasingly, third-party payors are requiring that drug companies provide them with discounts
and rebates from list prices and are challenging the prices charged for medical products. We have agreed to provide such
discounts and rebates to certain third-party payors. We expect increasing pressure to offer larger discounts and rebates.
Additionally, a greater number of third-party payors may seek discounts and rebates in order to offer or maintain access for
our products. We cannot be sure that high-quality coverage and reimbursement will be available for any product that we
commercialize and, if reimbursement is available, what the level of reimbursement will be and whether it will be
satisfactory.
Reimbursement rates may vary according to the use of the drug and the clinical setting in which it is used, may be based on
reimbursement levels already set for lower cost drugs and may be incorporated into existing payments for other services.
Net prices for drugs may be reduced by mandatory discounts or rebates required by government healthcare programs or
private payors and by any future relaxation of laws that presently restrict imports of drugs from policy and payment
limitations in setting their own reimbursement policies.
In August 2022, the Inflation Reduction Act of 2022 was signed into law. This legislation 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 subject manufacturers of some brand-name medications without generic or biosimilar competition to a
price negotiation program that results in a negotiated “maximum fair price” (or pay an excise tax for noncompliance), the
establishment of rebate payment requirements on manufacturers of drugs payable under Medicare Parts B and D to
penalize price increases that outpace inflation, and revises the way manufacturers provide discounts on Part D drugs. The
IRA also caps Medicare beneficiaries’ annual out-of-pocket drug expenses at $2,000 per year, thereby eliminating the
Medicare Part D coverage gap or “donut hole.” Substantial penalties can be assessed for noncompliance with the drug
pricing provisions in the IRA. The IRA could have the effect of reducing the prices we can charge and reimbursement we
receive for our products, thereby reducing our profitability, and could have a material adverse effect on our financial
condition, results of operations and growth prospects. The effect of the IRA on our business and the pharmaceutical
industry in general is not yet known.
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Our inability to expand and maintain coverage and profitable reimbursement rates from both government-funded and
private payors for our products could have a material adverse effect on our operating results, our ability to raise capital
needed to continue to commercialize our products and our overall financial condition.
The Affordable Care Act and any changes in healthcare law may increase the difficulty and cost for us to continue to
commercialize our products and affect the prices we may obtain.
The United States and many foreign jurisdictions have enacted or proposed legislative and regulatory changes affecting the
healthcare system that may affect our ability to profitably sell our products, including implementing cost-containment
programs to limit the growth of government-paid healthcare costs, including price controls, restrictions on reimbursement
and requirements for substitution of generic products for branded prescription drugs.
The Affordable Care Act was intended to broaden access to health insurance, reduce or constrain the growth of healthcare
spending, enhance remedies against fraud and abuse, add transparency requirements for the healthcare and health insurance
industries, impose new taxes and fees on the health industry and impose additional health policy reforms. There have been
significant ongoing judicial, administrative, executive and legislative efforts to modify or eliminate the Affordable Care
Act, and the Affordable Care Act has also been subject to challenges in the courts. Refer to the section in our Annual
Report entitled “Business — Government Regulation — Healthcare Reform.”
Further changes to and under the Affordable Care Act remain possible. It is unknown what form any such changes or any
law proposed to replace the Affordable Care Act would take, and how or whether it may affect our business in the future.
We expect that changes to the Affordable Care Act, the Medicare and Medicaid programs, changes allowing the federal
government to directly negotiate drug prices and changes stemming from other healthcare reform measures, especially with
regard to healthcare access, financing or other legislation in individual states, could have a material adverse effect on the
healthcare industry.
Any reduction in reimbursement from Medicare, Medicaid, or other government programs may result in a similar reduction
in payments from private payors. The implementation of cost containment measures or other healthcare reforms may
prevent us from being able to generate revenue and maintain profitability.
Social issues around the abuse of opioids, including law enforcement concerns over diversion of opioids and regulatory
and enforcement efforts to combat abuse, could decrease the potential market for our products and may adversely
impact external investor perceptions of our business.
Law enforcement and regulatory agencies may apply policies and guidelines that seek to limit the availability or use of
opioids. Such efforts may inhibit our ability to continue to commercialize our products.
Aggressive enforcement and unfavorable publicity regarding, for example, the use or misuse of oxycodone or other opioid
drugs; the limitations of abuse-resistant formulations; the ability of people who abuse drugs to discover previously
unknown ways to abuse opioid drugs, including Xtampza ER, the Nucynta Products and Belbuca; public inquiries and
investigations into prescription drug abuse; litigation; or regulatory activity regarding sales, marketing, distribution or
storage of opioid drugs could have a material adverse effect on our reputation. Such negative publicity could reduce the
potential size of the market for our products, decrease the revenues we are able to generate from their sale and adversely
impact external investor perceptions of our business. Similarly, to the extent opioid abuse becomes less prevalent or less
urgent of a public health issue, regulators and third-party payors may not be willing to pay a premium for abuse-deterrent
formulations of opioids.
Federal laws have been enacted to address the national epidemics of prescription opioid abuse and illicit opioid use,
including the Comprehensive Addiction and Recovery Act and the Substance Use-Disorder Prevention that Promotes
Opioid Recovery and Treatment for Patients and Communities Act. These laws are described in more detail in our Annual
Report under the caption “Business — Government Regulation — DEA and Opioid Regulation.”
If the FDA or other applicable regulatory authorities approve generic products with claims that compete with our
products, our sales could decline.
Once an NDA, including a Section 505(b)(2) application, is approved, the product covered thereby becomes a “listed drug”
which can, in turn, be cited by potential competitors in support of approval of an ANDA. The Federal Food, Drug, and
Cosmetic Act, FDA regulations and other applicable regulations and policies provide incentives to manufacturers to
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create modified, non-infringing versions of a drug to facilitate the approval of an ANDA or other application for generic
substitutes. These generic equivalents would be significantly less costly than ours to bring to market and companies that
produce generic equivalents are generally able to offer their products at lower prices. Additionally, under FDORA, FDA
will assign therapeutic equivalence ratings for certain prescription drugs approved via the Section 505(b)(2) NDA pathway
with respect to other approved drug products and it is unclear how assignment of these ratings will impact the market
opportunity for our products. Thus, after the introduction of a generic competitor, a significant percentage of the sales of
any branded product are typically lost to the generic product. Accordingly, competition from generic equivalents to our
products would substantially limit our ability to generate revenues and therefore, to obtain a return on the investments we
have made in our products. In the past, we have initiated litigation with generic competitors that have filed Paragraph IV
Certifications challenging certain of our patents. While we have entered into settlement agreements with certain
competitors, we are currently pursuing litigation to defend against Paragraph IV Certifications related to Belbuca. Refer to
Note 13, Commitments and Contingencies, to our consolidated financial statements included in Part IV of this Annual
Report on Form 10-K. We believe that we will continue to be subject to ANDA-related litigation, which can be costly and
distracting and has the potential to impact the long-term value of our products.
We may seek FDA pediatric exclusivity for some of our products. Pediatric exclusivity, if granted, adds six months of
patent term and marketing exclusivity to existing exclusivity periods for all formulations, dosage forms, and indications for
the active moiety, provided that at the time pediatric exclusivity is granted there is not less than nine months of term
remaining. The regulatory exclusivity period for Nucynta IR in the United States has been extended through July 3, 2026,
following the grant of New Patient Population exclusivity in pediatrics by the FDA in August 2023 based on data from
pediatric trials which were submitted in response to the FDA's Pediatric Written Request to evaluate the use of Nucynta as
a treatment for pain in pediatric patients aged 6 years and older. If FDA deems these data to be responsive to its Written
Request, the exclusivity of the entire Nucynta franchise could be extended an additional six months, to December 2025 for
Nucynta ER and January 2027 for Nucynta IR. However, there is no guarantee that FDA will agree that the Written
Request has been satisfied and that we will receive this additional exclusivity, or that we will maintain such exclusivity, if
granted.
In November 2017, the FDA issued a final guidance to assist industry in the development of generic versions of approved
opioids with abuse-deterrent formulations, including recommendations about the types of studies that companies should
conduct to demonstrate that the generic drug is no less abuse-deterrent than its brand-name counterpart. In the second half
of 2018, the FDA posted three revised product-specific guidances related to generic abuse-deterrent opioid formulations,
including one guidance specifically relating to Xtampza ER, which recommend specific in vivo studies and in vitro study
considerations for abuse deterrence evaluations. These guidances are part of the FDA’s wider focus on assisting developers
of generic abuse-deterrent formulations in navigating the regulatory path to market more quickly. Earlier market entry of
generic abuse-deterrent formulations could have a material adverse effect on our business.
Risks Related to Our Dependence on Third Parties
If the third-party manufacturers of our products fail to devote sufficient time and resources to these products, or their
performance is substandard, and/or we encounter challenges with our dedicated manufacturing suite at our third-party
manufacturer’s site for the manufacturing of Xtampza ER, our costs may be higher than expected and could have a
material adverse effect on our business.
We do not own any manufacturing facilities in drug development and commercial manufacturing. We currently have no
plans to build our own clinical or commercial scale manufacturing facility and do not have the resources and expertise to
manufacture and test, on a commercial scale, the technical performance of our products. We currently rely, and expect to
continue to rely, on a limited number of experienced personnel and contract manufacturers for our products, as well as
other vendors to formulate, test, supply, store and distribute our products, and we control only certain aspects of their
activities.
In 2020, we completed the build-out of a dedicated manufacturing suite for Xtampza ER at a site operated by our contract
manufacturing organization, Patheon, part of Thermo Fisher Scientific. This facility requires the maintenance of regulatory
approvals and other costs, all of which we absorb. We cannot guarantee that we will be able to continue to leverage the
dedicated manufacturing suite in a profitable manner. If the demand for Xtampza ER and any future related products never
meets our expectations and forecasts, or if we do not produce the output we plan, we may not be able to realize the return
on investment we anticipated, which would have a negative impact on our financial condition and results of operations.
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We have also transitioned commercial manufacturing for Nucynta ER from Janssen to Patheon. While we were successful
in our regulatory approval and validation activities, we could encounter issues in obtaining commercial supply from
Patheon's facility due to technical problems or challenges obtaining adequate and/or timely DEA procurement quota.
Although we have identified alternate sources for these services, it would be time-consuming, and require us to incur
additional costs, to qualify these sources. Our reliance on a limited number of vendors and, in particular, Patheon as our
single manufacturer for Xtampza ER and Nucynta ER, exposes us to the following risks, any of which could impact
commercialization of our products, result in higher costs, or deprive us of potential product revenues:
● Our contract manufacturer, or other third parties we rely on, may encounter difficulties in achieving the volume of
production needed to satisfy commercial demand, may experience technical issues that impact quality or
compliance with applicable and strictly enforced regulations governing the manufacture of pharmaceutical
products, may be affected by natural disasters that interrupt or prevent manufacturing of our products, may
experience shortages of qualified personnel to adequately staff production operations, may experience shortages
of raw materials and may have difficulties finding replacement parts or equipment;
● Our contract manufacturer could default on their agreement with us to meet our requirements for commercial
supplies of our products and/or we could experience technical problems in the operation of our dedicated
manufacturing suite;
● The use of alternate manufacturers may be difficult because the number of potential manufacturers that have the
necessary governmental licenses to produce narcotic products is limited. Additionally, the FDA and the DEA
must approve any alternative manufacturer of our products, before we may use the alternative manufacturer to
produce commercial supplies;
● It may be difficult or impossible for us to find a replacement manufacturer on acceptable terms quickly, or at all.
Our contract manufacturer and vendors may not perform as agreed or may not remain in the contract
manufacturing business for the time required to produce, store and distribute our products successfully; and
● If our contract manufacturer were to terminate our arrangement or fail to meet our commercial manufacturing
demands, we may be forced to delay our development and commercial programs.
Failure to obtain the necessary active pharmaceutical ingredients, excipients or components necessary to manufacture our
products could adversely affect our ability to continue to commercialize our products, which could in turn adversely affect
our results of operations and financial condition. Likewise, the inability of any of our sole or limited suppliers to provide
components that meet our specifications and requirements could adversely impact our ability to manufacture our products.
In addition, DEA regulations, through the quota procurement process, limit the amount of DEA-controlled active
pharmaceutical ingredient we have available for manufacture. Consequently, we are limited in our ability to maintain an
appreciable safety stock of finished drug product.
Our reliance on third parties reduces our control over our manufacturing and commercialization activities but does not
relieve us of our responsibility to ensure compliance with all required legal, regulatory and scientific standards. The FDA
and other regulatory authorities require our products to be manufactured according to cGMP. Any failure by our third-party
manufacturer to comply with cGMP or failure to scale up manufacturing processes, including any failure to deliver
sufficient quantities of products in a timely manner, could lead to inspection deficiencies, a shortage of commercial
product, or potential products liability exposure for any noncompliant distributed products. Such failure could also be the
basis for the FDA to issue a warning or untitled letter, withdraw approvals for products previously granted to us, or take
other regulatory or legal action, including recall or seizure, total or partial suspension of production, refusal to approve
pending applications or supplemental applications, detention of product, refusal to permit the import or export of products,
injunction, imposing civil penalties or pursuing criminal prosecution.
Any stock out, or failure to obtain sufficient supplies of any of our products, or the necessary active pharmaceutical
ingredients, excipients or components necessary to manufacture each of our products, could adversely affect our ability to
commercialize such products, which could in turn adversely affect our results of operations and financial condition.
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Because we currently rely on a sole supplier or limited number of suppliers to manufacture the active pharmaceutical
ingredient of our products, any production problems with any of these suppliers could have a material adverse effect on
us.
We currently rely on a sole supplier or limited number of suppliers to manufacture the active pharmaceutical ingredients of
our products. We contract with these suppliers for commercial supply to manufacture our products. Further, our suppliers
for Xtampza ER and the Nucynta Products active pharmaceutical ingredients also supply our primary competitor in the
extended-release oxycodone space, Purdue. Identifying alternate sources of active pharmaceutical ingredients for our
products is generally time-consuming and costly. Any changes that our suppliers make to the respective drug substance raw
materials, intermediates, or manufacturing processes would introduce technical and regulatory risks to our downstream
drug product supply. If our suppliers were to terminate an arrangement for an active pharmaceutical ingredient, or fail to
meet our supply needs (including as a result of any disruptions in personnel or the global supply chain), we might incur
substantial costs and be forced to delay our development or commercialization programs. Any such delay could have a
material adverse effect on our business.
Global supply chain disruptions and shortages may limit manufacturing and commercial supply of our products and
have a material impact on our business.
There are currently global supply chain disruptions and shortages caused by a variety of factors, including geopolitical
turmoil, such as the Ukrainian War and current conflict in Israel and Gaza. While we and our suppliers are still able to
receive sufficient inventory of the key materials and components needed, we could experience pressure on our supply
chain, including shipping delays, higher prices from suppliers, and reduced availability of materials, including excipients
and packaging components. To date, supply chain pressure has not had a material impact on our results of operations.
However, if these disruptions and shortages continue, we may in the future experience a material interruption to our supply
chain. Such an interruption could have a material adverse impact on our business, including but not limited to, our ability
to timely manufacture and distribute our products.
Manufacturing issues may arise that could increase product and regulatory approval costs, delay commercialization or
limit commercial supply.
In our current commercial manufacturing operations, and as we scale up manufacturing of our products and conduct
required stability testing, we may encounter product, packaging, equipment and process-related issues that may require
refinement or resolution in order to successfully commercialize our products. In the future, we may identify impurities,
which could result in increased scrutiny by regulatory authorities, delays in our clinical programs and regulatory approval,
increases in our operating expenses, failure to obtain or maintain approval or limitations in our commercial supply.
We depend on wholesale pharmaceutical distributors for retail distribution of our products; if we lose any of our
significant wholesale pharmaceutical distributors or their distribution network is disrupted, our financial condition and
results of operations may be adversely affected.
A significant percentage of our product shipments are to a limited number of independent wholesale pharmaceutical
distributors. Three of our wholesale pharmaceutical distributors represented greater than 90% of our product shipments for
the year ended December 31, 2023. Our loss of any of these wholesale pharmaceutical distributors’ accounts, or a material
reduction in their purchases or a significant disruption to transportation infrastructure or other means of distribution of our
products, could have a material adverse effect on our business, results of operations, financial condition and prospects. The
significance of each wholesale pharmaceutical distributor account to our business adversely impacts our ability to negotiate
favorable commercial terms with each such distributor, and as a result, we may be forced to accept terms that adversely
impact our results of operations.
In addition, these wholesaler customers comprise a significant part of the distribution network for pharmaceutical products
in the United States. This distribution network has undergone, and may continue to undergo, significant consolidation
marked by mergers and acquisitions. As a result, a small number of large wholesale distributors control a significant share
of the market. Consolidation of drug wholesalers has increased, and may continue to increase, competitive and pricing
pressures on pharmaceutical products. We cannot guarantee that we can manage these pricing pressures or that wholesaler
purchases will not fluctuate unexpectedly from period to period.
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Certain of our opioid products are subject to post-marketing requirements or commitments, which may, in some cases,
not be capable of timely or satisfactory completion without participation in consortia over which we have limited
control.
For certain of our products, we are subject to post-marketing requirements to conduct epidemiological studies and clinical
trials, or, in some cases, to conduct post-marketing surveillance or observational studies to gather additional information
about our products. For our opioid products, we generally intend to fulfill our PMRs by virtue of our participation in the
Opioid PMR Consortium (“OPC”). Although we retain discretion in how to discharge such PMRs, the scale and scope of
the studies required by the FDA make it cost prohibitive to discharge these requirements other than by joining the OPC that
was formed to conduct them. We are a member of the OPC and engage in decision-making as a member of that
organization, but do not have a majority. If the OPC fails to conduct sufficiently rigorous studies or is unable to achieve the
patient enrollment or other requirements established by the FDA, we may be unable to satisfy our PMRs and the FDA may
choose to withdraw or otherwise restrict its approval of our opioid products. Additionally, there may be certain PMRs or
post-marketing commitments that we fulfill on our own for our products, including via the conduct of post-marketing
surveillance or observational studies. If such studies lead to the discovery of adverse findings regarding the safety or
benefit profiles of our products, then the FDA may choose to withdraw or otherwise restrict the approval of our products or
the FDA or we may determine that labeling changes are warranted based on their finding. Such withdrawal or restriction or
labeling changes for our products would have an adverse impact on our business and financial condition.
Risks Related to Our Business and Strategy
We may not realize all the anticipated benefits from our future acquisitions, and we may be unable to successfully
integrate future acquisitions.
Our growth strategy will, in part, rely on acquisitions. We must plan and manage acquisitions effectively to achieve
revenue growth and maintain profitability in our evolving market. We may not realize all the anticipated benefits from our
future acquisitions, such as increased earnings, cost savings and revenue enhancements, for various reasons, including
difficulties integrating operations and personnel, higher than expected acquisition and operating costs or other difficulties,
inexperience with operating in new geographic regions, unknown liabilities, inaccurate reserve estimates and fluctuations
in market prices.
In addition, integrating acquired businesses and properties involves a number of special risks and unforeseen difficulties
can arise in integrating operations and systems and in retaining and assimilating employees. These difficulties include,
among other things:
● operating a larger organization;
● coordinating geographically disparate organizations, systems, and facilities;
● integrating corporate, technological, and administrative functions;
● diverting management’s attention from regular business concerns;
● diverting financial resources away from existing operations;
● increasing our indebtedness; and
● incurring potential environmental or regulatory liabilities and title problems.
Any of these or other similar risks could lead to potential adverse short-term or long-term effects on our operating results.
The process of integrating our operations could cause an interruption of, or loss of momentum in, the activities of our
business. Members of our management may be required to devote considerable amounts of time to this integration process,
which decreases the time they have to manage our business. If our management is not able to effectively manage the
integration process, or if any business activities are interrupted as a result of the integration process, our business could
suffer.
Our business may be adversely affected by certain events or circumstances outside our control, including
macroeconomic conditions and geopolitical turmoil.
Events or circumstances outside of our control, including macroeconomic conditions such as recession or depression,
inflation, and declines in consumer-spending could result in reduced demand for our products. An economic downturn
could result in business closures, higher levels of unemployment, or declines in consumer disposable income which
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could have an impact on the number of patients seeking and receiving treatment for conditions that might otherwise result
in the prescription of our products, as patients may make efforts to avoid or postpone seeking non-essential medical care to
allocate their resources to other priorities or essential items. These circumstances, in addition to the impact of geopolitical
turmoil, such as the ongoing Ukrainian War and current conflict in Israel and Gaza (including any escalation or expansion),
social unrest, political instability in the United States and elsewhere, terrorism, cyberwarfare or other acts of war, may
result in reduced demand for our products and negatively impact our sales, results of operations, and liquidity.
Security breaches and other disruptions to our, or our vendors’, information technology systems may compromise our
information and expose us to liability that could adversely impact our financial condition, operations, and reputation.
We, our collaborators, third-party providers, distributors, customers and other contractors utilize information technology
systems and networks (“Systems”) to transmit, store and otherwise process electronic data in connection with our business
activities, including our supply chain processes, operations and communications including, in some cases, our business
proprietary information, and Electronic Data Interchange (“EDI”) on purchase orders, invoices, chargebacks, among other
things. Our Systems, along with those of the third parties whom we rely on to process confidential and sensitive data in a
variety of contexts, are potentially vulnerable to a variety of evolving threats that may expose this data to unauthorized
persons or otherwise compromise its integrity. These threats may include, but are not limited to, social-engineering attacks
(including through phishing attacks), business email compromise, online and offline fraud, malicious code (such as viruses
and worms), malware (including as a result of advanced persistent threat intrusions), denial-of-service attacks, access
attacks (such as credential stuffing), personnel misconduct or error, ransomware attacks, supply-chain attacks, software
bugs, server malfunctions, software or hardware failures, loss of data or other information technology assets, adware,
telecommunications failures, earthquakes, fires, floods, and other similar threats.
We may expend significant resources to try to protect against these threats to our Systems. Certain data privacy and
security laws, as well as industry best practice standards, may require us to implement and maintain security measures.
While we have implemented security measures designed to protect our Systems and confidential and sensitive data, there
can be no assurance that these measures will be effective. Threat actors and their techniques change frequently, are often
sophisticated in nature, and may not be detected until after a security incident has occurred. If we, or a third party upon
whom we rely, experience a security incident or are perceived to have experienced a security incident, we may experience
adverse consequences. These consequences may include: government enforcement actions (for example, investigations,
fines, penalties, audits, and inspections); additional reporting requirements and/or oversight; restrictions on processing
sensitive data (including personal data); litigation (including class claims); indemnification obligations; negative publicity;
reputational harm; monetary fund diversions; interruptions in our operations (including availability of data); financial loss;
and other similar harms. Further, our insurance coverage may not be adequate or sufficient in type or amount to protect us
from or to mitigate liabilities arising out of our privacy and security practices.
Litigation or regulatory action regarding opioid medications could negatively affect our business.
Beginning in 2018, lawsuits alleging damages related to opioids have been filed naming us as a defendant along with other
manufacturers of prescription opioid medications. These lawsuits, filed in multiple jurisdictions, are brought by various
local governments as well as private claimants, against various manufacturers, distributors and retail pharmacies. These
lawsuits generally allege that we had engaged in improper marketing practices related to Xtampza ER and the Nucynta
Products. In March 2022, we entered into a Master Settlement Agreement resolving 27 pending opioid-related lawsuits
brought against us by cities, counties, and other subdivisions in the United States. As part of the Master Settlement
Agreement, we paid $2.75 million to the plaintiffs and the cases were dismissed, with prejudice. In late March 2023, three
new cases were filed in three federal courts, naming us as one of numerous defendants, from which we have been
dismissed.
Certain governmental and regulatory agencies are focused on the abuse of opioid medications, a concern we share, and we
have received Civil Investigative Demands or subpoenas from four state attorneys general investigating our sales and
marketing of opioids and seeking documents relating to the manufacture, marketing and sale of opioid medications. In
December 2021, we entered into an Assurance of Discontinuance with the Massachusetts Attorney General pursuant to
which we provided certain assurances and agreed to pay certain of the Massachusetts Attorney General’s costs of
investigation, in exchange for closure of the investigation and a release of claims pertaining to the subject matter of the
investigation. We are cooperating fully in the open investigations. Managing litigation and responding to governmental
investigations is costly and may involve a significant diversion of management attention. Such proceedings are
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unpredictable and may develop over lengthy periods of time. An adverse resolution of any of these lawsuits or
investigations may involve injunctive relief or substantial monetary penalties, either or both of which could have a material
adverse effect on our reputation, business, results of operations and cash flows.
We face substantial competition from other biotechnology and pharmaceutical companies, which may result in others
discovering, developing or commercializing products more successfully than we do.
Competition in the pain and opioid market is intense. Our competitors include major multinational pharmaceutical
companies, biotechnology companies and universities and other research institutions. Our products compete with oral
opioids, transdermal opioids, local anesthetic patches, stimulants and implantable and external infusion pumps that can be
used for infusion of opioids and local anesthetics. Products of these types are marketed by Actavis, Endo, Mallinckrodt,
Purdue, Teva, and others. Some of these current and potential future competitors may be addressing the same therapeutic
areas or indications as we are. Many of our current and potential future competitors have significantly greater research and
development capabilities than we do, have substantially more marketing, manufacturing, financial, technical, human and
managerial resources than we do, and have more institutional experience than we do. Our competitors have developed or
may develop technologies that are, or may be, the basis for competitive products that are safer, more effective or less costly
than our products. Moreover, oral medications, transdermal drug delivery systems, such as drug patches, injectable
products and implantable drug delivery devices are currently available treatments for chronic pain, are widely accepted in
the medical community and have a long history of use. These treatments will compete with our products and the
established use of these competitive products may limit the potential for our products to receive widespread acceptance.
Commercial sales of our products and any products we acquire, may expose us to expensive product liability claims, and
we may not be able to maintain product liability insurance on reasonable terms or at all.
We currently carry product liability insurance. Product liability claims may be brought against us by patients; healthcare
providers; or others using, administering or selling our products. If we cannot successfully defend ourselves against claims
that our products caused injuries, we could incur substantial liabilities. We may not be able to maintain insurance coverage
at a reasonable cost or in an amount adequate to satisfy any liability that may arise. Regardless of merit or eventual
outcome, liability claims may cause us to incur significant costs to defend the litigation.
Our relationships with customers and payors are subject to applicable anti-kickback, fraud and abuse, transparency,
and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, exclusion from
government healthcare programs, contractual damages, reputational harm, administrative burdens, and diminished
profits and future earnings.
Healthcare providers, physicians and payors play a primary role in the recommendation and prescription of our products.
Our arrangements with payors and customers may expose us to broadly applicable fraud and abuse and other healthcare
laws and regulations that may constrain the business or financial arrangements and relationships through which we market,
sell and distribute our products. Even though we do not and will not control referrals of healthcare services or bill
Medicare, Medicaid or other third-party payors directly, we may provide reimbursement guidance and support regarding
our products to our customers and patients. Federal and state healthcare laws and regulations pertaining to fraud and abuse
and patients’ rights are and will be applicable to our business. If a government authority were to conclude that we provided
improper advice to our customers and/or encouraged the submission of false claims for reimbursement, we could face
action by government authorities. If our operations are found to be in violation of any of these laws or any other
governmental regulations that may apply to us, we may be subject to significant civil, criminal and administrative
penalties, damages, fines, imprisonment, exclusion from participation in government funded healthcare programs, such as
Medicare and Medicaid, and the curtailment or restructuring of our operations.
We or the third parties upon whom we depend may be adversely affected by natural disasters and/or health epidemics,
and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.
Natural disasters could severely disrupt our operations, and have a material adverse effect on our business, results of
operations, financial condition and prospects. If a natural disaster, power outage, health epidemic or other event occurred
that prevented us from using all or a significant portion of our facilities, that damaged critical infrastructure, such as the
manufacturing facilities of our third-party contract manufacturers, or that otherwise disrupted operations, it might
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become difficult or, in certain cases, impossible for us to continue our business, and any disruption could last for a
substantial period of time.
The disaster recovery and business continuity plans we have in place, and the technology that we may rely upon to
implement such plans, may prove inadequate in the event of a serious disaster or similar event. We may incur substantial
expenses as a result of the limited nature of our disaster recovery and business continuity plans, which could have a
material adverse effect on our business, financial condition and results of operation.
Risks Related to Our Common Stock
The price of our common stock may be volatile and you may lose all or part of your investment.
The market price of our common stock is highly volatile and may be subject to wide fluctuations in response to numerous
factors described in these “Risk Factors,” some of which are beyond our control. The stock market in general, and
pharmaceutical and biotechnology companies in particular, have experienced extreme price and volume fluctuations. Broad
market and industry factors may negatively affect the market price of our common stock, regardless of our business model,
prospects or actual operating performance. The realization of any of these risks, or any of a broad range of other risks
discussed in this report, could have a material adverse effect on the market price of our common stock.
We are subject to anti-takeover provisions in our second amended and restated articles of incorporation and amended
and restated bylaws and under Virginia law that could delay or prevent an acquisition of our company, even if the
acquisition would be beneficial to our shareholders.
Certain provisions of Virginia law, the state in which we are incorporated, and our second amended and restated articles of
incorporation and amended and restated bylaws could hamper a third party’s acquisition of us, or discourage a third party
from attempting to acquire control of us. These provisions could limit the price that certain investors might be willing to
pay in the future for shares of our common stock. In addition, these provisions make it more difficult for our shareholders
to remove our Board of Directors or management or elect new directors to our Board of Directors.
If we fail to maintain an effective system of internal control over financial reporting, we may not be able to report our
financial condition, results of operations or cash flows accurately, which may adversely affect investor confidence in us
and, as a result, the value of our common stock.
The Sarbanes-Oxley Act requires, among other things, that we maintain effective internal control over financial reporting.
We are required, under Section 404 of the Sarbanes-Oxley Act, to furnish a report by management on, among other things,
the effectiveness of our internal control over financial reporting. If we identify one or more material weaknesses in our
internal control over financial reporting, we will be unable to assert that our internal control over financial reporting is
effective. We cannot assure you that there will not be material weaknesses or significant deficiencies in our internal control
over financial reporting in the future. Any failure to maintain internal control over financial reporting could severely inhibit
our ability to accurately report our financial condition, results of operations or cash flows. Further, we could lose investor
confidence in the accuracy and completeness of our financial reports, the market price of our common stock could decline,
and we could be subject to sanctions or investigations by NASDAQ, the SEC or other regulatory authorities. Failure to
remedy any material weakness in our internal control over financial reporting, or to implement or maintain other effective
control systems required of public companies, could also restrict our future access to capital markets.
Sales of our common stock in the public market, either by us or by our current shareholders, or the perception that
these sales could occur, could cause a decline in the market price of our securities. Moreover, the exercise of options
and other issuances of shares of common stock or securities convertible into or exercisable for shares of common stock
will dilute your ownership interests and may adversely affect the future market price of our common stock.
Sales of our common stock in the public market, either by us or by our current shareholders, or the perception that these
sales could occur, could cause a decline in the market price of our securities. All of the shares of our common stock held by
our current shareholders may be immediately eligible for resale in the open market either in compliance with an exemption
under Rule 144 promulgated under the Securities Act, or pursuant to an effective resale registration statement that we have
previously filed with the SEC. Such sales, along with any other market transactions, could adversely affect the market price
of our common stock. As of December 31, 2023, there were outstanding options to purchase an
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aggregate of 1,176,750 shares of our common stock at a weighted average exercise price of $19.48 per share, of which
options to purchase 1,158,209 shares of our common stock were then exercisable. The exercise of options at prices below
the market price of our common stock could adversely affect the price of shares of our common stock. Additional dilution
may result from the issuance of shares of our common stock in connection with collaborations or manufacturing
arrangements or in connection with other financing efforts.
There can be no assurance that we will repurchase additional shares of our common stock at all or at favorable prices.
In August 2021, our Board of Directors authorized a repurchase program for the repurchase of up to $100 million of shares
of our common stock at any time or times through December 31, 2022 (the “Prior Repurchase Program”). We repurchased
$61.9 million of shares pursuant to the Prior Repurchase Program prior to its expiration on December 31, 2022. In January
2023, our Board of Directors authorized a share repurchase program for the repurchase of up to $100.0 million of shares of
our common stock through December 31, 2023 (the “2023 Repurchase Program”). We repurchased $75.0 million of shares
pursuant to the 2023 Repurchase Program prior to its expiration on December 31, 2023.
In January 2024, our Board of Directors authorized a new share repurchase program for the repurchase of up to $150.0
million of shares of our common stock through June 30, 2025 (the “2024-2025 Repurchase Program”). The 2024-2025
Repurchase Program permits us to effect repurchases through a variety of methods, including open-market purchases
(including pursuant to a trading plan adopted in accordance with Rule 10b5-1 of the Exchange Act), privately negotiated
transactions, or otherwise in compliance with Rule 10b-18 of the Exchange Act. Share repurchases under the 2024-2025
Repurchase Program will depend upon, among other factors, our cash balances and potential future capital requirements,
our results of operations and financial condition, the price of our common stock on the NASDAQ Global Select Market,
and other factors that we may deem relevant. We can provide no assurance that we will continue to repurchase shares of
our common stock at favorable prices, if at all.
Item 1B. Unresolved Staff Comments
Not applicable.
Item 1C. Cybersecurity
Risk Management and Strategy
We maintain a cybersecurity program designed to assess, identify, and mitigate risks from cybersecurity threats. This
program is informed by the five elements of the National Institute of Standards and Technology framework: identify,
protect, detect, respond, and recover. We utilize various methods to achieve these objectives including but not limited to
company-wide policies and operating procedures, periodic testing, systems monitoring, patch management, and mandatory
ongoing employee trainings. Additionally, we partner with third-party experts to conduct periodic penetration tests and to
evaluate our information technology infrastructure for vulnerabilities. We also evaluate cybersecurity risks associated with
third-party vendors that provide the hosted applications we use in our financial close process through review of their
System and Organization Controls (“SOC”) 1 reports at least annually. We continue to invest in our information technology
infrastructure and cybersecurity program to strengthen our ability to protect the confidentiality, integrity, and availability of
our data and the security of our information systems.
In addition to our cybersecurity program, we assess cybersecurity risks as part of our overall risk management processes,
primarily through our annual Enterprise Risk Assessment. Our Enterprise Risk Assessment surveys various employees and
leaders throughout our organization with the goal of evaluating our risk landscape, enhancing our overall understanding of
risks to our business, and ultimately managing and/or mitigating identified risks. We assess various risks, including
cybersecurity related risks, based on the likelihood of an incident occurring, impact to our organization if an incident
occurred, and the level of internal control we currently have over the risk. The results are analyzed to identify
vulnerabilities and then risk management/mitigation plans are designed, implemented, and evaluated for effectiveness.
If a cybersecurity incident were to occur, we would implement our incident response plan in an effort to contain and
mitigate the threat. As part of our incident response plan, our Cybersecurity Incident Response Team (a cross-functional
taskforce comprised of senior representatives), would convene to assess the potential impact to our business, including
financial reporting requirements and legal implications.
40
We, like other companies in our industry, face a number of cybersecurity risks in connection with our business. Although
such risks have not materially affected us, including our business strategy, results of operations or financial condition, to
date, we and/or our vendors have, from time to time, experienced threats to, or security incidents, related to our data and
systems or that had the potential to otherwise impact our business. For more information about the cybersecurity risks we
face, refer to “Item 1A. Risk Factors.”
Governance
One of the key functions of our Board is informed oversight of our risk management process. Our Board administers this
oversight function directly through our Board as a whole, as well as through various standing committees of our Board that
address risks inherent in their respective areas of oversight. Our Audit Committee, a subcommittee of our Board, is
responsible for the oversight of risks from cybersecurity threats. The Audit Committee receives updates at least quarterly
from our Head of Information Technology regarding developments in our information technology infrastructure and
cybersecurity program. This includes updates, as appropriate, on key information technology initiatives, new and existing
cybersecurity risks, how management is managing those risks, and, if any, material cybersecurity incidents and the impact
to our business and performance.
At the management level, our Head of Information Technology is responsible for assessing and managing risks from
cybersecurity threats through oversight of our information technology infrastructure and cybersecurity program. The
individual occupying this role has over 20 years of experience in information technology and cybersecurity and has served
in senior cybersecurity leadership positions for over 10 years. Thus, we believe our Head of Information Technology is
well-qualified to serve in this role. Our Head of Information Technology conducts bi-weekly meetings with our information
technology department to remain apprised of cybersecurity matters. If a cybersecurity incident were to occur, our Head of
Information Technology may inform our Executive Vice President and Head of Technological Operations and/or Audit
Committee, depending on the severity of the incident in accordance with the established severity and response matrix as
defined in our incident response plan.
Item 2. Properties
Our corporate headquarters are located in Stoughton, Massachusetts, where we lease 50,678 square feet of office and
laboratory space. We use this facility for commercial and general and administrative purposes. The corporate headquarters
lease expires in July 2029 and the lease term may be extended for two additional five-year terms at our election.
We believe that our existing facilities are adequate for our current and expected future needs. We may seek to negotiate
new leases or evaluate additional or alternate space for our operations. We believe that appropriate alternative space is
readily available on commercially reasonable terms.
Item 3. Legal Proceedings
Discussion of legal matters is incorporated by reference from Note 13, Commitments and Contingencies, to the
Consolidated Financial Statements included in Item 8 of Part II of this Annual Report on Form 10-K.
Item 4. Mine Safety Disclosures
Not applicable.
PART II
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity
Securities
Market Information
Our common stock has been publicly traded on the NASDAQ Global Select Market under the symbol “COLL” since May
7, 2015. Prior to May 7, 2015, there was no public trading market for our common stock.
41
Holders
As of January 31, 2024, there were 12 holders of record of our common stock. The number of holders of record does not
include beneficial owners whose shares are held by nominees in street name.
Dividends
We have never declared or paid cash dividends on our common stock, and we do not expect to pay any cash dividends on
our common stock in the foreseeable future.
Stock Performance Graph
The following graph sets forth the Company’s total cumulative shareholder return as compared to the NASDAQ Composite
Index and the NASDAQ Biotechnology Index for the 5-year period beginning on December 31, 2018 through December
31, 2023.
Total cumulative shareholder return assumes an investment of $100.00 in cash in our common stock at the beginning of the
5-year period compared to the same investment in the NASDAQ Composite Index and the NASDAQ Biotechnology
Index. Such returns are based on historical results and are not intended to suggest future performance. Data for the
NASDAQ Composite Index and NASDAQ Biotechnology Index assume reinvestment of dividends, however no dividends
have been declared on our common stock to date.
$100 investment in stock or index
Collegium Pharmaceutical, Inc. (COLL)
NASDAQ Composite Index (IXIC)
NASDAQ Biotechnology Index (NBI)
December 31,
2018
December 31,
2023
$
$
$
100.00
100.00
100.00
$
$
$
179.27
226.24
143.60
The performance graph and related information shall not be deemed to be “soliciting material” or to be “filed” with the
SEC, nor shall such information be incorporated by reference into any future filing under the Securities Act, except to the
extent that we specifically incorporate it by reference into such filing.
Recent Sales of Unregistered Securities
There were no unregistered sales of equity securities during the period covered by this Form 10-K.
42
Purchases of Equity Securities by the Issuer and Affiliated Purchasers
The following table sets forth shares of common stock repurchased under our repurchase program authorized by our Board
of Directors in January 2023 (the “2023 Repurchase Program”), as well as shares transferred to us from employees in
satisfaction of minimum tax withholding obligations associated with the vesting of performance share units and restricted
stock units during the three months ended December 31, 2023:
Period
October 1, 2023 through October 31, 2023
November 1, 2023 through November 30, 2023
December 1, 2023 through December 31, 2023
Total
Total number
of shares
purchased
Average
Price
Paid per
Share
$ 23.10
27.09
27.12
1,394,570 (2)$ 25.75
467,247
867,532
59,791
Maximum
approximate
dollar value of
Shares that may
yet be purchased
under the plans
or programs
(in thousands)
50,000
30,000
25,000
25,000
Total number of
shares purchased as
part of publicly
announced plans or
programs (1)
$
462,442
865,426
57,349
1,385,217 (2)$
(1) The 2023 Repurchase Program was announced on January 4, 2023. The 2023 Repurchase Program provided for
the repurchase of up to $100.0 million of outstanding shares of our common stock at any time or times through
December 31, 2023. The 2023 Repurchase Program expired on December 31, 2023 with approximately $25.0
million available for repurchase at the time of expiration.
(2) The difference, if any, between the total number of shares purchased and the total number of shares purchased as
part of a publicly announced program relates to common stock withheld by us for employees to satisfy their tax
withholding obligations arising upon the vesting of performance share units and restricted stock units granted
under our Amended and Restated 2014 Stock Incentive Plan.
Item 6. [Reserved]
43
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations
You should read the following discussion and analysis of our financial condition and results of operations together with our
consolidated financial statements and related notes appearing elsewhere in this Form 10-K. The following discussion
contains forward-looking statements that involve risks, uncertainties and assumptions. Our actual results and the timing of
certain events could differ materially from those anticipated in these forward-looking statements as a result of many
factors. We discuss factors that we believe could cause or contribute to these differences below and elsewhere in this Form
10-K, including those set forth under “Forward-looking Statements” and “Risk Factors,” as revised and supplemented by
those risks described from time to time in other reports which we file with the SEC.
Overview
We are building a leading, diversified specialty pharmaceutical company committed to improving the lives of people living
with serious medical conditions. 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.
Xtampza ER, an abuse-deterrent, oral formulation of oxycodone, was approved by the United States Food and Drug
Administration (“FDA”) in April 2016 for the management of severe and persistent pain that requires an extended
treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. We commercially
launched Xtampza ER in June 2016.
The Nucynta Products are extended-release (“ER”) and immediate-release (“IR”) formulations of tapentadol. Nucynta ER
is indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid
analgesic, including neuropathic pain associated with diabetic peripheral neuropathy in adults, and for which alternate
treatment options are inadequate. Nucynta IR is indicated for the management of acute pain severe enough to require an
opioid analgesic and for which alternative treatments are inadequate in adults and pediatric patients aged 6 years and older
with a body weight of at least 40 kg. We began shipping and recognizing product sales on the Nucynta Products in January
2018 and began marketing the Nucynta Products in February 2018. In August 2023, the FDA granted New Patient
Population exclusivity in pediatrics for Nucynta IR. This grant extended the period of U.S. exclusivity for Nucynta IR from
June 27, 2025 to July 3, 2026.
On March 22, 2022, we acquired BioDelivery Sciences International, Inc. (“BDSI”), a specialty pharmaceutical company
working to deliver innovative therapies for individuals living with serious and debilitating chronic conditions (the “BDSI
Acquisition”). Upon closing of the BDSI Acquisition, we acquired Belbuca and Symproic.
Belbuca is a buccal film that contains buprenorphine, a Schedule III opioid, and was approved by the FDA in October 2015
for severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which
alternative options are inadequate. Symproic was approved by the FDA in March 2017 for the treatment of opioid-induced
constipation (“OIC”) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior
cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. We began shipping and
recognizing product sales related to Belbuca and Symproic in March 2022.
Financial Operations Overview
Product Revenues
Product revenues through the year ended December 31, 2023 were primarily generated from sales of Xtampza ER, the
Nucynta Products, Belbuca, and Symproic. In accordance with Accounting Standards Codification Topic 606, Revenue
from Contracts with Customers, (“ASC 606”) product sales are recorded upon delivery of products to customers (upon the
transfer of control of the product to the customer), net of a provision for estimated chargebacks, rebates, sales incentives
and allowances, distribution service fees, and returns.
Cost of Product Revenues
Cost of product revenues include amortization and impairment expense for the intangible assets acquired in connection
with business combinations and asset acquisitions, royalty expenses, the cost of active pharmaceutical ingredient, the cost
of producing finished goods that correspond with revenue for the reporting period, as well as certain period costs
44
related to freight, packaging, stability and quality testing. Refer to Note 5, License Agreements, and Note 11, Goodwill and
Intangible Assets, for further detail around the intangible assets acquired from the BDSI Acquisition, the Nucynta
Intangible Asset and royalty expenses.
Research and Development Expenses
Research and development expenses have historically consisted of product development expenses incurred in identifying,
developing, and testing product candidates including stock-based compensation; costs associated with conducting our
clinical and non-clinical activities, including clinical and non-clinical trials that we conduct for post-marketing
requirements; and costs for laboratory supplies, depreciation of lab equipment, and other expenses including allocated
expenses for rent and maintenance of facilities. These costs have historically been expensed as incurred.
As of April 1, 2022, we focused entirely on commercial products rather than research and development and redirected
resources from research and development activities. As such, there were no expenses incurred in research and development
after the three months ended March 31, 2022.
Selling, General and Administrative Expenses
Selling, general and administrative expenses consist primarily of salaries and employee-related costs, including stock-
based compensation and travel expenses for our employees. Other selling, general and administrative expenses include
facility-related costs and professional fees for directors, accounting and legal services, and expenses associated with
obtaining and maintaining patents. As we continue to invest in the commercialization of our products, we expect our
selling, general and administrative expenses to continue to be substantial for the foreseeable future.
Interest Expense
Interest expense consists primarily of cash and non-cash interest costs related to our debt, including the term loan issued in
March 2022 in connection with the BDSI Acquisition (the “2022 Term Loan”), the term notes (the “2020 Term Loan”) and
convertible notes (the “2026 Convertible Notes”) issued in February 2020 in connection with the Nucynta Acquisition, and
convertible notes issued in February 2023 (the “2029 Convertible Notes”).
On March 22, 2022 the outstanding balance related to the 2020 Term Loan was fully paid in connection with the closing of
the BDSI Acquisition and establishment of the 2022 Term Loan.
Interest Income
Interest income consists of interest earned on our cash, cash equivalents, and marketable securities.
Provision for Income Taxes
The provision for income taxes reflects expense or tax benefit for federal and state income taxes, as well as the impact of
non-deductible expenses. During the year ended December 31, 2021, we removed the valuation allowance on the
substantial majority of our deferred tax assets, resulting in the recognition of a discrete deferred tax benefit of $78.0 million
in 2021.
Critical Accounting Policies and Significant Judgments and Estimates
Our “Management’s Discussion and Analysis of Financial Condition and Results of Operations” are based on our
consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles
in the United States of America (“GAAP”). The preparation of these financial statements requires us to make estimates and
judgments that affect the reported amounts of assets, liabilities, revenue and expenses and the disclosure of contingent
assets and liabilities in our consolidated financial statements. Estimates include revenue recognition, including the
estimates of product returns, discounts and allowances related to commercial sales of our products, estimates related to the
fair value of assets acquired and liabilities assumed, including acquired intangible assets and the fair value of inventory
acquired, estimates utilized in the ongoing valuation of inventory related to potential unsalable product, estimates of useful
lives with respect to intangible assets, accounting for stock-based compensation, contingencies, intangible assets and
deferred tax valuation allowances. We base our estimates and assumptions on
45
historical experience when available and on various factors that we believe are reasonable under the circumstances, the
results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily
apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis. Actual results may differ
from these estimates under different assumptions or conditions.
We believe that several accounting policies are important to understanding our historical and future performance. We refer
to these policies as “critical” because these specific areas generally require us to make judgments and estimates about
matters that are uncertain at the time we make the estimate, and different estimates—which also would have been
reasonable—could have been used, which would have resulted in different financial results. While our significant
accounting policies are described in more detail in Note 2, Summary of Significant Accounting Policies, to our consolidated
financial statements appearing elsewhere in this Form 10-K, we believe the following accounting policies to be most
critical to the significant judgments and estimates used in the preparation of our consolidated financial statements.
Revenue Recognition
Our accounting policy for revenue recognition will have a substantial impact on reported results and relies on certain
estimates. Estimates are based on historical experience, current conditions and various other assumptions that we believe
are reasonable, the results of which form the basis for making judgments about the carrying values of assets, liabilities and
equity and the amounts of revenues and expenses. Actual results may differ from these estimates under different
assumptions or conditions.
Product Revenue
Our only source of revenue to date has been generated by sales of our products, which are primarily sold to distributors
(“customers”), which in turn sell the product to pharmacies and others for the treatment of patients. Revenue for product
sales is recognized when a customer obtains control of promised goods or services, in an amount that reflects the
consideration which the entity expects to receive in exchange for those goods or services. This generally occurs upon
delivery to our customers when estimated provisions for chargebacks, rebates, sales incentives and allowances, distribution
service fees, and returns are reasonably determinable. Therefore, product sales are recorded upon delivery to our customers
net of estimated chargebacks, rebates, sales incentives and allowances, distribution service fees, as well as estimated
product returns.
Sales Deductions
Sales deductions consist primarily of provisions for: (i) rebates and incentives, including managed care rebates,
government rebates, co-pay program incentives, and sales incentives and allowances; (ii) product returns, including return
estimates for our products; and (iii) trade allowances and chargebacks, including fees for distribution service fees, prompt
pay discounts, and chargebacks. We estimate the amount of variable consideration that should be included in revenue under
the expected value method for all sales deductions other than trade allowances, which are estimated under the most likely
amount method. These provisions reflect our best estimates of the amount of revenue to which we are entitled based on the
terms of our contracts.
Provisions for rebates and incentives are based on the estimated amount of rebates and incentives to be claimed on the
related sales from the period. As our rebates and incentives are based on products dispensed to patients, we are required to
estimate the expected value of claims at the time of product delivery to distributors. Given that distributors sell the product
to pharmacies, which in turn dispense the product to patients, claims can be submitted significantly after the related sales
are recognized. Our estimates of these claims are based on the historical experience of existing or similar programs,
including current contractual and statutory requirements, specific known market events and trends, industry data, and
estimated distribution channel inventory levels. Accruals and related reserves required for rebates and incentives are
adjusted as new information becomes available, including actual claims. If actual results vary, we may need to adjust these
estimates, which could have an effect on earnings in the period of the adjustment.
Provisions for product returns, including returns for Xtampza, the Nucynta Products, Belbuca and Symproic, are based on
product-level returns rates, including processed as well as unprocessed return claims, in addition to relevant market events
and other factors. Estimates of the future product returns are made at the time of revenue recognition to determine the
amount of consideration to which we expect to be entitled (that is, excluding the products expected to be returned).
46
At the end of each reporting period, we analyze trends in returns rates and update our assessment of variable consideration
for returns. To the extent we receive amounts in excess of what we expect to be entitled to receive due to a product return,
we do not recognize revenue when we transfer products to customers but instead recognize those excess amounts received
as a refund liability. We update the measurement of the refund liability at the end of each reporting period for changes in
expectations about the amount of refunds with the corresponding adjustments recognized as revenue (or reductions of
revenue).
We provide the right of return to our customers for an 18-month window beginning six months prior to expiration and up
until twelve months after expiration. Our customers short-pay an existing invoice upon notice of a product return claim.
Adjustments to the preliminary short-paid claims are processed when the return claim is validated and finalized. Our return
policy requires that product is returned and that the return is claimed within the 18-month window. Refer to Note 3,
Revenue from Contracts with Customers, for more information.
Provisions for trade allowances and chargebacks are primarily based on customer-level contractual terms. Accruals and
related reserves are adjusted as new information becomes available, which generally consists of actual trade allowances
and chargebacks processed. Actual results may differ from these estimates under different assumptions or conditions.
Business Combination Accounting and Valuation of Acquired Assets
We completed the BDSI Acquisition on March 22, 2022, which was accounted for as a business combination. To determine
whether the acquisition should be accounted for as a business combination or as an asset acquisition, we made certain
judgments regarding whether the acquired set of activities and assets met the definition of a business. Judgment is required
in assessing whether the acquired processes or activities, along with their inputs, would be substantive to constitute a
business, as defined by U.S. GAAP.
The acquisition method of accounting requires that we recognize the assets acquired and liabilities assumed at their
acquisition date fair values. Goodwill is measured as the excess of consideration transferred over the acquisition date net
fair values of the assets acquired and the liabilities assumed. The determination of the fair value of the acquired assets and
liabilities assumed is a critical accounting estimate because the estimation of fair values requires significant management
judgment and requires various assumptions based on non-observable inputs that are included in valuation models. An
income approach, which generally relies upon projected cash flow models, is used in estimating the fair value of the
acquired intangible assets and the fair value of acquired inventory. These cash flow projections are based on management’s
estimates of economic and market conditions including the estimated future cash flows from revenues of acquired assets,
the timing and projection of costs and expenses and the related profit margins, tax rates, and an appropriate discount rate.
During the measurement period, which occurs before finalization of the purchase price allocation, changes in assumptions
and estimates that result in adjustments to the fair values of assets acquired and liabilities assumed, if based on facts and
circumstances existing at the acquisition date, are recorded on a retroactive basis as of the acquisition date, with the
corresponding offset to goodwill. Any adjustments not based on facts and circumstances existing at the acquisition date, or
if subsequent to the conclusion of the measurement period, will be recorded to our consolidated statements of operations.
Intangible Assets
We record the fair value of acquired finite-lived intangible assets as of the transaction date. Intangible assets are then
amortized over their estimated useful lives using either the straight-line method, or if reliably determinable, based on the
pattern in which the economic benefit of the asset is expected to be utilized, which is generally based on our cash flow
projections. Future events, such as competition, technological advances, or other changes, are subject to uncertainty and
could cause subsequent evaluations to cash flow projections. We test intangible assets for potential impairment whenever
triggering events or circumstances present an indication of impairment. If the sum of expected undiscounted future cash
flows of the intangible assets (or asset group) is less than the carrying amount of such assets, the intangible assets would be
written down to the estimated fair value, calculated based on the present value of expected future cash flows. As of
December 31, 2023, our intangible assets included those acquired in connection with the BDSI Acquisition and the
Nucynta Intangible Asset.
47
Income Taxes
We utilize the asset and liability method of accounting for income taxes. Under this method, deferred tax assets and
liabilities are determined based on the difference between the financial statement carrying amounts and tax basis of assets
and liabilities using enacted tax rates in effect for years in which the temporary differences are expected to reverse.
We provide a valuation allowance when it is more likely than not that deferred tax assets will not be realized. In
determining the extent to which a valuation allowance for deferred tax assets is required, we evaluate all available evidence
including projections of future taxable income, carryback opportunities, reversal of certain deferred tax liabilities, and other
tax planning strategies, all of which are subject to uncertainty. Certain deferred tax assets, such as net operating losses and
tax credits, expire at varying dates and are generally subject to annual limitations under Section 382 of the Internal
Revenue Code of 1986, as amended (“IRC 382”). Significant judgment is required in making these evaluations, including
comparing future annual income projections to the expiration dates and annual limitations of such assets. To the extent our
future expectations change, we would have to assess the recoverability of these deferred tax assets at that time.
As a result of sustained positive earnings history as demonstrated through cumulative earnings, we are using projections of
future taxable income as a source of realizing our deferred tax assets. We have maintained a valuation allowance on the
portion of our deferred tax assets that are not more likely than not to be realized due to tax limitation or other conditions of
$5.8 million as of December 31, 2023.
Results of Operations
In this section, we discuss the results of our operations for the year ended December 31, 2023 compared to the year ended
December 31, 2022. For a discussion of the year ended December 31, 2022 compared to the year ended December 31,
2021, refer to Part II, Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations”
in our Annual Report on Form 10-K for the year ended December 31, 2022.
Comparison of the Years Ended December 31, 2023 and 2022
The following table summarizes the results of our operations for the years ended December 31, 2023 and 2022:
Product revenues, net
Cost of product revenues
Cost of product revenues (excluding intangible asset amortization)
Intangible asset amortization and impairment
Total cost of products revenues
Gross profit
Operating expenses
Research and development
Selling, general and administrative
Total operating expenses
Income from operations
Interest expense
Interest income
Loss on extinguishment of debt
Income (loss) before income taxes
Provision for (benefit from) income taxes
Net income (loss)
$
48
Years Ended December 31,
2022
2023
(in thousands)
$
566,767 $
463,933
94,838
145,760
240,598
326,169
—
159,208
159,208
166,961
(83,339)
15,615
(23,504)
75,733
27,578
48,155
$
118,190
136,255
254,445
209,488
3,983
172,186
176,169
33,319
(63,213)
1,047
—
(28,847)
(3,845)
(25,002)
Product revenues, net
Product revenues, net were $566.8 million for the year ended December 31, 2023 (“2023”), compared to $463.9 million for
the year ended December 31, 2022 (“2022”), representing a $102.9 million increase. The $102.9 million increase is
primarily due to increases in revenue for Belbuca of $55.6 million, Xtampza ER of $38.6 million, the Nucynta Products of
$6.3 million, and Symproic of $4.2 million, partially offset by decreases in other revenue of $1.8 million.
The increase in revenue for Belbuca of $55.6 million and Symproic of $4.2 million is primarily due to a full year of
revenue in 2023, compared to a partial year of revenue in 2022 due to the timing of the BDSI Acquisition.
The increase in revenue for Xtampza ER of $38.6 million is primarily due to lower gross-to-net adjustments primarily
related to provisions for rebates and higher gross price, partially offset by lower sales volume and higher gross-to-net
adjustments related to provisions for returns.
The increase in revenue for the Nucynta Products of $6.3 million is primarily due to lower gross-to-net adjustments
primarily related to provisions for rebates and returns and higher gross price, partially offset by decreased sales volume.
Cost of product revenues
Cost of product revenues (excluding intangible asset amortization) was $94.8 million for 2023, compared to $118.2 million
for 2022. The $23.4 million decrease was primarily related to 2022 including higher cost of product revenues related to the
step-up basis in inventory acquired from BDSI as well as lower sales volume in 2023 for Xtampza and the Nucynta
Products.
Intangible asset amortization was $145.8 million for 2023, compared to $136.3 million for 2022. The $9.5 million increase
in intangible asset amortization was due to a full year of amortization expense recognized in 2023 related to the intangible
assets acquired from BDSI of which $435.0 million of consideration was allocated to our acquired intangible assets,
compared to a partial year of amortization expense in 2022. This increase was partially offset by a decrease in amortization
expense as a result of the FDA granting New Patient Population exclusivity in pediatrics for Nucynta IR to July 3, 2026,
resulting in an extension of the estimated useful life of the underlying intangible asset. The intangible assets are amortized
on a straight-line basis over the respective estimated useful lives.
Operating expenses
We did not recognize research and development expenses in 2023, compared to $4.0 million recognized in 2022. The $4.0
million decrease was due to redirection of resources from research and development activities during 2022 as we shifted
our focus to supporting our commercial products rather than research and development.
Selling, general and administrative expenses were $159.2 million for 2023, compared to $172.2 million for 2022. The
$13.0 million decrease was primarily related to:
● a decrease in acquisition related expenses classified as selling, general and administrative of $30.6 million;
partially offset by
● an increase in salaries, wages, and benefits of $8.7 million, primarily due to increases in personnel costs for
employees retained following the BDSI Acquisition and higher stock-based compensation expenses;
● an overall increase in audit and legal expenses of $5.0 million, primarily due to an $8.5 million litigation
settlement;
● an increase in sales and marketing expenses of $3.1 million, primarily due to expenses incurred to support the
ongoing commercialization of products acquired from BDSI; and
● an increase in regulatory expenses of $0.8 million, primarily due to a full year of expenses related to products
acquired from BDSI.
Interest expense and Interest income
Interest expense was $83.3 million for 2023, compared to $63.2 million for 2022. The $20.1 million increase was primarily
due to the 2022 Term Loan that we entered into in connection with the BDSI Acquisition, higher interest rates impacting
our variable rate term loan debt, and higher interest expense due to the issuance of the 2029 Convertible Notes (offset by
the partial repurchase of the 2026 Convertible Notes).
49
Interest income was $15.6 million for 2023, compared to $1.0 million for 2022. The $14.6 million increase was primarily
due to a higher overall balance invested in 2023 compared to 2022 and higher interest rates earned on cash equivalents and
marketable securities.
Loss on extinguishment of debt
We recognized a $23.5 million loss on extinguishment of debt in 2023 in connection with the repurchase of a portion of our
2026 Convertible Notes. This transaction involved a contemporaneous exchange of cash between us and holders of the
2026 Convertible Notes participating in the issuance of the 2029 Convertible Notes. The repurchase of the 2026
Convertible Notes and issuance of the 2029 Convertible Notes were deemed to have substantially different terms based on
the present value of the cash flows immediately prior to and after the exchange. Therefore, the repurchase of the 2026
Convertible Notes was accounted for as a debt extinguishment.
Income Taxes
The provision for income taxes was $27.6 million for 2023, compared to a $3.8 million benefit from income taxes for
2022. The tax provision for 2023 was impacted by non-deductible costs, including non-deductible costs associated with the
debt extinguishment that occurred in the first quarter of 2023 as well as non-deductible costs related to stock-based
compensation, including 162(m) limitations. In 2022, we recognized a deferred tax benefit, partially offset by state income
tax expense. The provision for income taxes in 2022 primarily consisted of state income tax for states for which our state-
level NOLs did not fully offset state-level taxable income. The effective tax rate was 36.4% and 13.3% for 2023 and 2022,
respectively.
Liquidity and Capital Resources
Sources of Liquidity
Historically, we have funded our operations primarily through the private placements and/or public offerings of our
preferred stock, common stock, and convertible notes; commercial bank debt; and cash inflows from sales of our products.
We are primarily dependent on the commercial success of Belbuca, Xtampza, and the Nucynta Products. In March 2022,
our debt balance increased significantly as we modified the 2020 Term Loan with Pharmakon to an increased principal
balance of $650.0 million to fund a portion of the consideration paid to complete the BDSI Acquisition. We paid $100.0
million in principal payments during the first year of the 2022 Term Loan and the remaining $550.0 million balance will be
paid in equal quarterly installments over the remaining three years of the term note. As of December 31, 2023, the
outstanding principal balance of the 2022 Term Loan was $412.5 million, of which $183.3 million in principal payments
are due within the next 12 months. As of December 31, 2023, the outstanding principal balance of the Convertible Notes
was $267.9 million, of which $26.4 million is due in 2026 and $241.5 million is due in 2029. As of December 31, 2023,
and December 31, 2022, we had $238.9 million and $173.7 million in cash and cash equivalents, respectively.
We believe that our cash, cash equivalents, and marketable securities as of December 31, 2023, together with expected cash
inflows from operations, will enable us to fund our operating expenses, debt service and capital expenditure requirements
under our current business plan for the foreseeable future.
Borrowing Arrangements and Equity Offerings
The following transactions represent our material borrowing arrangements and equity offerings: the 2022 Term Loan, the
2026 Convertible Notes, and the 2029 Convertible Notes. Refer to Note 14, Debt, for more information.
50
Cash flows
In this section, we discuss cash flows for the year ended December 31, 2023 compared to the year ended December 31,
2022. For a discussion of the year ended December 31, 2022 compared to the year ended December 31, 2021, refer to Part
II, Item 7, "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our Annual
Report on Form 10-K for the year ended December 31, 2022.
Net cash provided by operating activities
Net cash used in investing activities
Net cash (used in) provided by financing activities
Net increase (decrease) in cash, cash equivalents and restricted cash
Years Ended December 31,
2023
2022
(in thousands)
$
$
274,749 $
(70,812)
(140,178)
63,759
$
124,230
(573,691)
436,723
(12,738)
Operating activities. Cash provided by operating activities was $274.7 million in 2023, compared to $124.2 million in
2022. The $150.5 million increase in cash provided by operating activities was primarily due to the increase in cash flow
from operating results, which reflects operating earnings, after adjustment for non-cash items that are included in net
income, including higher intangible asset amortization as a result of the BDSI Acquisition and recognition of a loss on
extinguishment of debt in connection with the repurchase of a portion of our 2026 Convertible Notes, as well as changes in
working capital.
Investing activities. Cash used in investing activities was $70.8 million in 2023, compared to $573.7 million in 2022. The
$502.9 million decrease in cash used in investing activities was primarily due to the use of $572.1 million for the BDSI
Acquisition in 2022, net of cash acquired, partially offset by purchases and maturities of marketable securities in 2023.
Financing activities. Cash used in financing activities was $140.2 million in 2023, compared to cash provided by financing
activities of $436.7 million in 2022. The $576.9 million decrease was primarily due to:
● the repayment of the outstanding balance of the 2020 Term Loan and establishment of the 2022 Term Loan in
connection with the BDSI Acquisition, which was accounted for as a debt modification and resulted in $517.7
million in proceeds from the term note modification in 2022;
● an increase in repayments of term notes of $87.5 million; and
● an increase in repurchases of common stock of $60.9 million, which includes $75.0 million related to accelerated
share repurchases executed in 2023; partially offset by
● the repurchase of a portion of our 2026 Convertibles Notes and issuance of our 2029 Convertible Notes which
resulted in net proceeds of $96.6 million in 2023.
Funding requirements
We believe that our cash, cash equivalents, and marketable securities as of December 31, 2023, together with expected cash
inflows from operations, will enable us to fund our operating expenses, debt service and capital expenditure requirements
under our current business plan for the foreseeable future. However, we are subject to all the risks common to the
commercialization and development of new pharmaceutical products, and we may encounter unforeseen expenses,
difficulties, complications, delays and other unknown factors that may adversely affect our business.
We have significant future capital requirements, including:
● expected operating expenses to manufacture and commercialize our products and to operate our organization;
● repayment of outstanding principal amounts and interest in connection with our 2022 Term Loan and Convertible
Notes;
● royalties we pay on sales of certain products within our portfolio;
● operating lease obligations;
● minimum purchase obligations in connection with our contract manufacturer; and
● cash paid for income taxes.
51
In addition, we have significant potential future capital requirements, including:
● we may enter into business development transactions, including acquisitions, collaborations, licensing
arrangements and equity investments, that require additional capital; and
● in January 2024, our Board of Directors authorized a new share repurchase program for the repurchase of up to
$150.0 million of shares of our common stock through June 30, 2025. Future share repurchases will depend upon,
among other factors, our cash balances and potential future capital requirements, our results of operations and
financial conditions, the price of our common stock on the NASDAQ Global Select Market, and other factors that
we may deem relevant.
Contractual Obligations
Our contractual obligations as of December 31, 2023 that will affect our future liquidity include our term loan, including
interest; convertible senior notes, including interest; operating lease obligations; and purchase obligations. For further
detail regarding our term notes and convertible senior notes, refer to Note 14, Debt. For further detail regarding our
operating lease obligations, refer to Note 15, Leases.
Our purchase obligations represent the minimum purchase obligations of up to $3.0 million per year with our contract
manufacturer which are in effect as of December 31, 2023 and will remain in effect each year until the termination of our
manufacturing agreement.
We also have employment agreements with executive officers that would require us to make severance payments to them if
we terminate their employment without cause or the executives resign for good cause. These payments are contingent upon
the occurrence of various future events, and the amounts payable under these provisions depend upon the level of
compensation at the time of termination of employment, and therefore, are not calculable at this time.
Non-GAAP Financial Measures
To supplement our financial results presented on a GAAP basis, we have included information about certain non-GAAP
financial measures. We believe the presentation of these non-GAAP financial measures, when viewed with our results
under GAAP and the accompanying reconciliations, provide analysts, investors, lenders, and other third parties with
insights into how we evaluate normal operational activities, including our ability to generate cash from operations, on a
comparable year-over-year basis and manage our budgeting and forecasting. In addition, certain non-GAAP financial
measures, primarily Adjusted EBITDA, are used to measure performance when determining components of annual
compensation for substantially all non-sales force employees, including senior management.
We may discuss the following financial measures that are not calculated in accordance with GAAP in our quarterly and
annual reports, earnings press releases and conference calls.
Adjusted EBITDA
Adjusted EBITDA is a non-GAAP financial measure that represents GAAP net income or loss adjusted to exclude interest
expense, interest income, the benefit from or provision for income taxes, depreciation, amortization, stock-based
compensation, and other adjustments to reflect changes that occur in our business but do not represent ongoing operations.
Adjusted EBITDA, as used by us, may be calculated differently from, and therefore may not be comparable to, similarly
titled measures used by other companies.
There are several limitations related to the use of adjusted EBITDA rather than net income or loss, which is the nearest
GAAP equivalent, such as:
● adjusted EBITDA excludes depreciation and amortization, and, although these are non-cash expenses, the assets
being depreciated or amortized may have to be replaced in the future, the cash requirements for which are not
reflected in adjusted EBITDA;
● we exclude stock-based compensation expense from adjusted EBITDA although: (i) it has been, and will continue
to be for the foreseeable future, a significant recurring expense for our business and an important part of our
compensation strategy; and (ii) if we did not pay out a portion of our compensation in the form of stock-based
compensation, the cash salary expense included in operating expenses would be higher, which would affect our
cash position;
● adjusted EBITDA does not reflect changes in, or cash requirements for, working capital needs;
52
● adjusted EBITDA does not reflect the benefit from or provision for income taxes or the cash requirements to pay
taxes;
● adjusted EBITDA does not reflect historical cash expenditures or future requirements for capital expenditures or
contractual commitments;
● we exclude impairment expenses from adjusted EBITDA and, although these are non-cash expenses, the asset(s)
being impaired may have to be replaced in the future, the cash requirements for which are not reflected in
adjusted EBITDA;
● we exclude restructuring expenses from adjusted EBITDA. Restructuring expenses primarily include employee
severance and contract termination costs that are not related to acquisitions. The amount and/or frequency of
these restructuring expenses are not part of our underlying business;
● we exclude litigation settlements from adjusted EBITDA, as well as any applicable income items or credit
adjustments due to subsequent changes in estimates. This does not include our legal fees to defend claims, which
are expensed as incurred;
● we exclude acquisition related expenses as the amount and/or frequency of these expenses are not part of our
underlying business. Acquisition related expenses include transaction costs, which primarily consisted of
financial advisory, banking, legal, and regulatory fees, and other consulting fees, incurred to complete the
acquisition, employee-related expenses (severance cost and benefits) for terminated employees after the
acquisition, and miscellaneous other acquisition related expenses incurred;
● we exclude recognition of the step-up basis in inventory from acquisitions (i.e., the adjustment to record
inventory from historic cost to fair value at acquisition) as the adjustment does not reflect the ongoing expense
associated with sale of our products as part of our underlying business; and
● we exclude losses on extinguishments of debt as these expenses are episodic in nature and do not directly
correlate to the cost of operating our business on an ongoing basis.
Adjusted EBITDA for the years ended December 31, 2023 and 2022 was as follows:
GAAP net income (loss)
Adjustments:
Interest expense
Interest income
Loss on extinguishment of debt
Provision for (benefit from) income taxes
Depreciation
Amortization
Impairment expense
Stock-based compensation
Litigation settlements
Acquisition related expenses
Recognition of step-up basis in inventory
Total adjustments
Adjusted EBITDA
Years Ended December 31,
2023
2022
(in thousands)
48,155
$
83,339
(15,615)
23,504
27,578
3,496
145,760
—
27,136
8,500
—
15,116
318,814
366,969
$
$
(25,002)
63,213
(1,047)
—
(3,845)
2,684
131,469
4,786
22,874
—
31,297
39,584
291,015
266,013
$
$
$
Adjusted EBITDA was $367.0 million for 2023 compared to $266.0 million for 2022. The $101.0 million increase was
primarily due to higher revenues and gross profit before excluded costs, partially offset by higher adjusted operating
expenses.
53
The following is a summary of 2023 quarterly Adjusted EBITDA:
GAAP net (loss) income
Adjustments:
Interest expense
Interest income
Loss on extinguishment of debt
(Benefit from) provision for income taxes
Depreciation
Amortization
Stock-based compensation
Litigation settlements
Recognition of step-up basis in inventory
Total adjustments
Adjusted EBITDA
$
$
Adjusted Operating Expenses
First Quarter
Second Quarter
Third Quarter
Fourth Quarter
$
(17,426) $
(in thousands)
13,007 $
20,634 $
31,940
21,427
(2,747)
23,504
(131)
817
37,466
6,035
8,500
10,170
105,041 $
87,615 $
21,863
(4,027)
—
4,790
895
37,463
7,072
—
4,748
72,804 $
85,811 $
20,768
(4,538)
—
8,149
835
36,317
7,027
—
198
68,756 $
89,390 $
19,281
(4,303)
—
14,770
949
34,514
7,002
—
—
72,213
104,153
Adjusted operating expenses is a non-GAAP financial measure that represents GAAP operating expenses adjusted to
exclude stock-based compensation expense, and other adjustments to reflect changes that occur in our business but do not
represent ongoing operations.
Adjusted operating expenses for the years ended December 31, 2023 and 2022 were as follows:
GAAP operating expenses
Adjustments:
Stock-based compensation
Litigation settlements
Acquisition related expenses
Total adjustments
Adjusted operating expenses
Years Ended December 31,
2023
2022
(in thousands)
159,208
$
27,136
8,500
—
35,636
123,572
$
$
176,169
22,874
—
31,297
54,171
121,998
$
$
$
Adjusted operating expenses were $123.6 million for 2023 compared to $122.0 million for 2022. The $1.6 million increase
was primarily driven by:
● an increase in salaries, wages, and benefits (excluding stock-based compensation) of $1.8 million, primarily due
to increases in personnel costs for employees retained following the BDSI Acquisition;
● an increase in sales and marketing expenses of $3.1 million, primarily due to expenses incurred to support the
ongoing commercialization of products acquired from BDSI;
● an increase in regulatory expenses of $0.8 million, primarily due to a full year of expenses related to products
acquired from BDSI; partially offset by
● a decrease in audit and legal expenses (excluding litigation settlements) of $3.5 million.
54
The following is a summary of 2023 quarterly adjusted operating expenses:
GAAP operating expenses
Adjustments:
Stock-based compensation
Litigation settlements
Total adjustments
Adjusted operating expenses
$
$
First Quarter
Second Quarter
Third Quarter
Fourth Quarter
52,775
$
38,193
$
35,298
$
32,942
(in thousands)
6,035
8,500
14,535
38,240
$
7,072
—
7,072
31,121
$
7,027
—
7,027
28,271
$
7,002
—
7,002
25,940
Adjusted Net Income and Adjusted Earnings Per Share
Adjusted net income is a non-GAAP financial measure that represents GAAP net income or loss adjusted to exclude
significant income and expense items that are non-cash or not indicative of ongoing operations, including consideration of
the tax effect of the adjustments. Adjusted earnings per share is a non-GAAP financial measure that represents adjusted net
income per share. Adjusted weighted-average shares - diluted is calculated in accordance with the treasury stock, if-
converted, or contingently issuable accounting methods, depending on the nature of the security.
Adjusted net income and adjusted earnings per share for the years ended December 31, 2023 and 2022 were as follows:
GAAP net income (loss)
Adjustments:
Non-cash interest expense
Loss on extinguishment of debt
Amortization
Impairment expense
Stock-based compensation
Litigation settlements
Acquisition related expenses
Recognition of step-up basis in inventory
Income tax effect of above adjustments (1)
Total adjustments
Non-GAAP adjusted net income
Adjusted weighted-average shares — diluted (2)
Adjusted earnings per share (2)
Years Ended December 31,
2023
2022
(in thousands, except share and per share data)
$
$
$
$
48,155 $
8,635
23,504
145,760
—
27,136
8,500
—
15,116
(53,526)
175,125 $
223,280 $
(25,002)
8,285
—
131,469
4,786
22,874
—
31,297
39,584
(60,553)
177,742
152,740
41,788,125
5.47 $
39,531,814
3.96
(1) The income tax effect of the adjustments was calculated by applying our blended federal and state statutory rate
to the adjustments that have a tax effect. The blended federal and state statutory rate for the years ended
December 31, 2023 and 2022 were 25.9% and 26.0%, respectively. As such, the non-GAAP effective tax rates for
the years ended December 31, 2023 and 2022 were 23.4% and 25.4%, respectively.
(2) Adjusted weighted-average shares - diluted were calculated using the “if-converted” method for the convertibles
notes in accordance with ASC 260, Earnings per Share. As such, adjusted weighted-average shares – diluted
includes shares related to the assumed conversion of our convertible notes and the associated cash interest
expense added-back to non-GAAP adjusted net income. For the years ended December 31, 2023 and 2022,
adjusted weighted-average shares – diluted includes 6,793,421 and 4,925,134 shares, respectively, attributable to
our convertible notes. In addition, adjusted earnings per share includes other potentially dilutive securities to the
extent that they are not antidilutive.
55
The following is a summary of 2023 quarterly adjusted net income and adjusted earnings per share:
GAAP net (loss) income
Adjustments:
Non-cash interest expense
Loss on extinguishment of debt
Amortization
Stock-based compensation
Litigation settlements
Recognition of step-up basis in inventory
Income tax effect of above adjustments (1)
Total adjustments
Non-GAAP adjusted net income
Adjusted weighted-average shares — diluted (2)
Adjusted earnings per share (2)
First Quarter Second Quarter Third Quarter Fourth Quarter
(in thousands, except share and per share data)
$
(17,426) $
13,007 $
20,634 $
31,940
2,287
23,504
37,466
6,035
8,500
10,170
(18,874)
69,088 $
51,662 $
2,261
—
37,463
7,072
—
4,748
(12,100)
39,444 $
52,451 $
2,124
—
36,317
7,027
—
198
(11,300)
34,366 $
55,000 $
1,963
—
34,514
7,002
—
—
(11,252)
32,227
64,167
40,196,015
42,849,952
42,058,820
1.32 $
1.26 $
1.34 $
41,279,982
1.58
$
$
$
(1) The income tax effect of the adjustments was calculated by applying our blended federal and state statutory rate
to the adjustments that have a tax effect. The blended federal and state statutory rate for the three months ended
March 31, June 30, September 30, and December 31, 2023 were 26.8%, 24.0%, 25.6%, and 25.9%, respectively.
As such, the non-GAAP effective tax rates for the three months ended March 31, June 30, September 30, and
December 31, 2023 were 21.5%, 23.5%, 24.7%, and 25.9%, respectively.
(2) Adjusted weighted-average shares - diluted were calculated using the “if-converted” method for the convertibles
notes in accordance with ASC 260, Earnings per Share. As such, adjusted weighted-average shares – diluted
includes shares related to the assumed conversion of our convertible notes and the associated cash interest
expense added-back to non-GAAP adjusted net income. For the three months ended March 31, June 30,
September 30, and December 31, 2023, adjusted weighted-average shares – diluted includes 4,646,372,
7,509,104, 7,509,104, and 7,509,104 shares, respectively, attributable to our convertible notes. In addition,
adjusted earnings per share includes other potentially dilutive securities to the extent that they are not antidilutive.
Item 7A. Quantitative and Qualitative Disclosures about Market Risks
Our primary exposure to market risk is interest rate sensitivity in connection with our investment portfolio and the 2022
Term Loan. None of these market risk sensitive instruments are held for trading purposes.
Investment Portfolio
Our investment portfolio includes financial instruments that are sensitive to interest rate risks. Our investment portfolio is
used to preserve capital, maintain liquidity sufficient to meet cash flow requirements, and maximize returns commensurate
with our risk appetite. We invest in instruments that meet the credit quality, diversification, liquidity, and maturity
standards outlined in our investment policy.
As of December 31, 2023, our investment portfolio includes $82.0 million of cash equivalents and $71.6 million of
marketable securities, which are primarily comprised of money market funds, U.S. Treasury securities, corporate debt, and
government-sponsored securities. Our money market funds are short-term highly liquid investments, and our marketable
securities have active secondary or resale markets to help ensure liquidity. We account for marketable securities as
available-for-sale, thus, no gains or losses are realized due to changes in the fair value of our marketable securities unless
we sell our investments prior to maturity or incur a credit loss. Furthermore, our investment policy includes guidelines
limiting the term-to-maturity of our investments. Due to the nature of our investments, we do not believe that the fair value
of our investments has a material exposure to interest rate risk.
56
2022 Term Loan
The 2022 Term Loan bears interest at a rate based upon the Secured Overnight Financing Rate (“SOFR”) plus a spread
adjustment of 0.26% (subject to a floor of 1.20%), plus a margin of 7.5% per annum. Based on the outstanding principal
amount of the 2022 Term Loan as of December 31, 2023 of $412.5 million and the applicable interest rate, a hypothetical
1% increase or decrease in interest rates would increase or decrease future interest expense by approximately $4.1 million.
Item 8. Consolidated Financial Statements and Supplementary Data
Our Consolidated Financial Statements, together with the reports of our independent registered public accounting firms,
begin on page F-1 of this Form 10-K.
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
None.
Item 9A. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of the Chief Executive Officer and the Chief Financial Officer, has evaluated the
effectiveness of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange
Act, as of the end of the period covered by this report. The term “disclosure controls and procedures” as defined in Rules
13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to
ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is
recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Based on
this evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and
procedures were effective as of December 31, 2023.
Management’s Report on Internal Control Over Financial Reporting
Internal control over financial reporting refers to the process designed by, or under the supervision of, our Chief Executive
Officer and Chief Financial Officer, and effected by our Board of Directors, management and other personnel, to provide
reasonable assurance regarding the reliability of financial reporting and the preparation of consolidated financial statements
for external purposes in accordance with generally accepted accounting principles, and includes those policies and
procedures that:
(1) pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and
dispositions of our assets;
(2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of consolidated
financial statements in accordance with generally accepted accounting principles, and that our receipts and
expenditures are being made only in accordance with authorizations of our management and directors; and
(3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or
disposition of our assets that could have a material effect on the consolidated financial statements.
Internal control over financial reporting cannot provide absolute assurance of achieving financial reporting objectives
because of its inherent limitations. Internal control over financial reporting is a process that involves human diligence and
compliance and is subject to lapses in judgment and breakdowns resulting from human failures. Internal control over
financial reporting also can be circumvented by collusion or improper management override. Also, projections of any
evaluation of effectiveness of internal control over financial reporting to future periods are subject to the risk that controls
may become inadequate because of changes in conditions, or that the degree of compliance with policies or procedures
may deteriorate. Because of such limitations, there is a risk that material misstatements may not be prevented
57
or detected on a timely basis by internal control over financial reporting. However, these inherent limitations are known
features of the financial reporting process. Therefore, it is possible to design into the process safeguards to reduce, though
not eliminate, this risk.
Management is responsible for establishing and maintaining adequate internal control over our financial reporting, as such
term is defined in Rules 13a 15(f) and 15d 15(f) under the Exchange Act. Under the supervision and with the participation
of our management, including our Chief Executive Officer and Chief Financial Officer, we conducted an evaluation of the
effectiveness of our internal control over financial reporting. Management has used the framework set forth in the report
entitled “Internal Control—Integrated Framework (2013)” published by the Committee of Sponsoring Organizations of the
Treadway Commission (COSO) to evaluate the effectiveness of our internal control over financial reporting. Based on our
evaluation, Management has concluded that our internal control over financial reporting was effective as of December 31,
2023.
Changes in Internal Control Over Financial Reporting
As required by Rule 13a-15(d) of the Exchange Act, our management, including our Chief Executive Officer and our Chief
Financial Officer, conducted an evaluation of the internal control over financial reporting to determine whether any
changes occurred during the quarter ended December 31, 2023 that have materially affected, or are reasonably likely to
materially affect, our internal control over financial reporting. Based on that evaluation, our Chief Executive Officer and
Chief Financial Officer did not identify any change in our internal control over financial reporting during the fiscal quarter
ended December 31, 2023 that has materially affected, or is reasonably likely to materially affect, our internal control over
financial reporting.
58
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the shareholders and the Board of Directors of Collegium Pharmaceutical, Inc.
Opinion on Internal Control over Financial Reporting
We have audited the internal control over financial reporting of Collegium Pharmaceutical, Inc. and subsidiaries (the
“Company”) as of December 31, 2023, based on criteria established in Internal Control — Integrated Framework (2013)
issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). In our opinion, the Company
maintained, in all material respects, effective internal control over financial reporting as of December 31, 2023, based on
criteria established in Internal Control — Integrated Framework (2013) issued by COSO.
We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United
States) (PCAOB), the consolidated financial statements as of and for the year ended December 31, 2023, of the Company
and our report dated February 22, 2024, expressed an unqualified opinion on those financial statements.
Basis for Opinion
The Company’s management is responsible for maintaining effective internal control over financial reporting and for its
assessment of the effectiveness of internal control over financial reporting, included in the accompanying Management’s
Report on Internal Control Over Financial Reporting. Our responsibility is to express an opinion on the Company’s internal
control over financial reporting based on our audit. We are a public accounting firm registered with the PCAOB and are
required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the
applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform
the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in
all material respects. Our audit included obtaining an understanding of internal control over financial reporting, assessing
the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control
based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances. We
believe that our audit provides a reasonable basis for our opinion.
Definition and Limitations of Internal Control over Financial Reporting
A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the
reliability of financial reporting and the preparation of financial statements for external purposes in accordance with
generally accepted accounting principles. A company’s internal control over financial reporting includes those policies and
procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the
transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded
as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and
that receipts and expenditures of the company are being made only in accordance with authorizations of management and
directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized
acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also,
projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate
because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
/s/ Deloitte & Touche LLP
Boston, Massachusetts
February 22, 2024
59
Item 9B. Other Information
Insider Trading Arrangements
During the three months ended December 31, 2023, none of our directors or officers adopted, amended, or terminated a
“Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408(a) of
Regulation S-K.
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
Not applicable.
Item 10. Directors, Executive Officers, and Corporate Governance
PART III
Other than the information regarding our executive officers provided in Part I of this report under the heading “Business —
Our Executive Officers,” the information required to be furnished pursuant to this item is incorporated herein by reference
to our definitive proxy statement for the 2024 Annual Meeting of the Shareholders.
Our Board of Directors has adopted a Code of Ethics applicable to all of our employees, executive officers and directors.
The Code of Ethics is available on our website at www.collegiumpharma.com. Our Board of Directors is responsible for
overseeing compliance with the Code of Ethics, and our Board of Directors or an appropriate committee thereof must
approve any waivers of the Code of Ethics for employees, executive officers or directors. Disclosure regarding any
amendments to the Code of Ethics, or any waivers of its requirements, will be made on our website.
Insider Trading Policies
Our Board of Directors has adopted an Insider Trading Policy which governs the purchase, sales, and/or other dispositions
of our securities by directors, officers, and employees. Our Insider Trading Policy is attached hereto as Exhibit 19 and
incorporated herein.
Item 11. Executive Compensation
The information required by this Item 11 is incorporated herein by reference from our definitive proxy statement for the
2024 Annual Meeting of Shareholders under the captions “Compensation Discussion and Analysis,” “Executive
Compensation” (excluding the information under the heading “Pay Versus Performance”), “Director Compensation” and
“Compensation Committee Report.”
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
The information required by this Item 12 is incorporated herein by reference from our definitive proxy statement for the
2024 Annual Meeting of Shareholders under the captions “Compensation Discussion and Analysis,” “Executive
Compensation” (excluding the information under the heading “Pay Versus Performance”), “Director Compensation” and
“Compensation Committee Report.”
Item 13. Certain Relationships and Related Transactions, and Director Independence
The information required by this Item 13 is incorporated herein by reference from our definitive proxy statement for the
2024 Annual Meeting of Shareholders under the captions “Compensation Discussion and Analysis,” “Executive
Compensation” (excluding the information under the heading “Pay Versus Performance”), “Director Compensation” and
“Compensation Committee Report.”
60
Item 14. Principal Accountant Fees and Services
The information required by this Item 14 is incorporated herein by reference from our definitive proxy statement for the
2024 Annual Meeting of Shareholders under the captions “Compensation Discussion and Analysis,” “Executive
Compensation” (excluding the information under the heading “Pay Versus Performance”), “Director Compensation” and
“Compensation Committee Report.”
Item 15. Exhibits and Financial Statement Schedules
Consolidated Financial Statements
PART IV
Refer to Part II, Item 8 for the Consolidated Financial Statements required to be included in this Form 10-K.
Consolidated Financial Statement Schedules
All financial statement schedules are omitted because they are not applicable or the required information is included in the
Consolidated Financial Statements or notes thereto.
Exhibits
Exhibit
Number
Exhibit Description
2.1 †
Agreement and Plan of Merger, dated as of February 14, 2022, by and among Collegium
Pharmaceutical, Inc., Bristol Acquisition Company, Inc. and BioDelivery Sciences International, Inc.
3.1 † Third Amended and Restated Articles of Incorporation of Collegium Pharmaceutical, Inc.
3.2 † Amended and Restated Bylaws of Collegium Pharmaceutical, Inc.
4.1 †
4.2 †
4.3 †
4.4 †
4.5 †
4.6 †
10.1 †
Indenture, dated as of February 13, 2020, between Collegium Pharmaceutical, Inc. and The Bank of
New York Mellon Trust Company, N.A., as trustee.
First Supplemental Indenture, dated as of February 13, 2020, between Collegium Pharmaceutical, Inc.
and The Bank of New York Mellon Trust Company, N.A., as trustee.
Form of certificate representing the 2.625% Convertible Senior Notes due 2026 (included as Exhibit
A to Exhibit 4.2).
Indenture, dated as of February 10, 2023, between Collegium Pharmaceutical, Inc. and The Bank of
New York Mellon Trust Company, N.A., as trustee.
Form of certificate representing the 2.875% Convertible Senior Notes due 2029 (included as Exhibit
A to Exhibit 4.4).
Description of the Registrant’s Securities Registered Pursuant to Section 12 of the Securities
Exchange Act of 1934.
Office Lease agreement by and between Campanelli-Trigate 100 TCD Stoughton, LLC, and
Collegium Pharmaceutical, Inc as of March 23, 2018.
10.2 +† 2015 Employee Stock Purchase Plan.
10.3 +† Performance Bonus Plan.
10.4(a) +† Amended and Restated 2014 Stock Incentive Plan.
10.4(b) +†
10.4(c) +†
10.4(d) +
10.4(e) +†
Form of Incentive Stock Option Agreement under the Amended and Restated 2014 Stock Incentive
Plan.
Form of Non-Qualified Stock Option Agreement under the Amended and Restated 2014 Stock
Incentive Plan.
Form of Restricted Stock Unit Agreement under the Amended and Restated 2014 Stock Incentive
Plan.
Form of Performance Share Unit Agreement under the Amended and Restated 2014 Stock Incentive
Plan.
10.5 † Form of Indemnification Agreement.
10.6 +†
Amended & Restated Employment Agreement, dated December 27, 2020, by and between Collegium
Pharmaceutical, Inc. and Joseph Ciaffoni.
(1)
(2)
(3)
(4)
(4)
(4)
(5)
(5)
(6)
(7)
(8)
(9)
(8)
(8)
(8)
(10)
(9)
(11)
61
10.7 +†
10.8 +†
10.9 †
10.10* †
10.11* †
10.12 +†
10.13* †
10.14
10.15 †
10.16 †
10.17* †
10.18 +†
10.19 +†
10.20 +†
10.21 +†
10.22 +†
19
21.1
23.1
31.1
31.2
32.1
32.2
97
101
(11)
(11)
(12)
(12)
(13)
(14)
(15)
(16)
(17)
(18)
(18)
(18)
(18)
(18)
(18)
Amended & Restated Employment Agreement, dated December 27, 2020, by and between Shirley
Kuhlmann and Collegium Pharmaceutical, Inc.
Amended & Restated Employment Agreement, dated December 27, 2020, by and between Collegium
Pharmaceutical, Inc. and Scott Dreyer.
License Agreement (U.S.), dated as of January 13, 2015, by and among Grünenthal GmbH, Janssen
Research & Development, LLC, Assertio Therapeutics, Inc. and Collegium Pharmaceutical, Inc.
Consent Agreement, dated January 30, 2020, by and among Grünenthal GmbH, Assertio
Therapeutics, Inc. and Collegium Pharmaceutical, Inc.
Settlement Agreement, dated September 29, 2020, by and among Collegium Pharmaceutical, Inc. and
Teva Pharmaceuticals USA, Inc.
Employment Agreement, dated May 24, 2021, by and between Colleen Tupper and Collegium
Pharmaceutical, Inc.
Amended and Restated Loan Agreement, dated as of March 22, 2022, by and among Collegium
Pharmaceutical, Inc., the guarantors party thereto, BioPharma Credit PLC, and BioPharma Credit
Investments V (Master) LP, as lenders.
First Amendment and Consent to Amended and Restated Loan Agreement, dated as of January 3,
2023, by and among Collegium Pharmaceutical, Inc., the guarantors party thereto, BioPharma Credit
PLC, and BioPharma Credit Investments V (Master) LP, as lenders.
Second Amendment to Loan Agreement, dated as of February 6, 2023, Amended and Restated Loan
Agreement, dated as of March 22, 2022, by and among Collegium Pharmaceutical, Inc., the
guarantors party thereto, BioPharma Credit PLC, and BioPharma Credit Investments V (Master) LP,
as lenders.
Third Amendment to Loan Agreement, dated as of June 23, 2023, by and among Collegium
Pharmaceutical, Inc., the guarantors party thereto, BioPharma Credit PLC, and Bio Pharma Credit
Investments V (Master) LP, as lenders.
Exclusive License Agreement, dated April 4, 2019, between the Company and Shionogi, Inc.
(incorporated by reference to Exhibit 10.19 to the Annual Report on Form 10-K filed by BDSI on
March 9, 2022).
Amendment to Employment Agreement, dated January 20, 2022 by and between Collegium
Pharmaceutical, Inc. and Joseph Ciaffoni.
Amendment to Employment Agreement, dated January 20, 2022 by and between Collegium
Pharmaceutical, Inc. and Colleen Tupper.
Amendment to Employment Agreement, dated January 20, 2022 by and between Collegium
Pharmaceutical, Inc. and Shirley Kuhlmann.
Amendment to Employment Agreement, dated January 20, 2022 by and between Collegium
Pharmaceutical, Inc. and Scott Dreyer.
Employment Agreement, dated March 23, 2022 by and between Collegium Pharmaceutical, Inc. and
Thomas Smith.
Insider Trading Policy
Subsidiaries of Collegium Pharmaceutical, Inc.
Consent of Deloitte & Touche LLP, Independent Registered Public Accounting Firm.
Certifying Statement of the Chief Executive Officer pursuant to Section 302 of the Sarbanes‑Oxley
Act of 2002.
Certifying Statement of the Chief Financial Officer pursuant to Section 302 of the Sarbanes‑Oxley
Act of 2002.
Certifying Statement of the Chief Executive Officer pursuant to Section 1350 of Title 18 of the United
States Code.
Certifying Statement of the Chief Financial Officer pursuant to Section 1350 of Title 18 of the United
States Code.
Compensation Recovery Policy
The following financial information from this Annual Report on Form 10-K for the year ended
December 31, 2023, formatted in Inline XBRL: (i) Consolidated Balance Sheets as of December 31,
2023, and 2022, (ii) Consolidated Statements of Operations for the years ended December 31, 2023,
2022 and 2021, (iii) Consolidated Statements of Shareholders' Equity for the Years Ended
December 31, 2023, 2022 and 2021, (iv) Consolidated Statements of Cash Flows for the years ended
December 31, 2023, 2022 and 2021, and (v) Notes to Consolidated Financial Statements, tagged as
blocks of text.
62
104
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)
†Previously filed.
+Indicates management contract or compensatory plan.
* Certain portions of the exhibits that are not material and would be competitively harmful if publicly disclosed have been
redacted pursuant to Item 601(b)(10)(iv) of Regulation S-K. Copies of the unredacted exhibits will be furnished to the
Securities and Exchange Commission (“SEC”) upon request.
(1) Previously filed as an exhibit to the registrant’s Current Report on Form 8-K filed with the SEC on February 14, 2022.
(2) Previously filed as an exhibit to the registrant’s Quarterly Report on Form 10-Q for the quarterly period ended June
30, 2020 filed with the SEC on August 5, 2020.
(3) Previously filed as an exhibit to the registrant’s Current Report on Form 8-K filed with the SEC on December 4, 2017.
(4) Previously filed as an exhibit to the registrant’s Current Report on Form 8-K filed with the SEC on February 13, 2020.
(5) Previously filed as an exhibit to the registrant’s Current Report on Form 8-K filed with the SEC on February 13, 2023.
(6) Previously filed as an exhibit to the registrant’s Annual Report on Form 10-K for the year ended December 31, 2022
filed with the SEC on February 23, 2023.
(7) Previously filed as an exhibit to the registrant’s Quarterly Report on Form 10-Q for the quarterly period ended March
31, 2018 filed with the SEC on May 9, 2018.
(8) Previously filed as an exhibit to the registrant’s Registration Statement on Form S-8 (File No. 333-207744) filed with
the SEC on November 2, 2015.
(9) Previously filed as an exhibit to the registrant’s Registration Statement on Form S-1/A (File No. 333-203208) filed
with the SEC on April 27, 2015.
(10) Previously filed as an exhibit to the registrant’s Quarterly Report on Form 10-Q for the quarterly period ended March
31, 2019 filed with the SEC on May 8, 2019.
(11) Previously filed as an exhibit to the registrant’s Current Report on Form 8-K filed with the SEC on December 30,
2020.
(12) Previously filed as an exhibit to the registrant’s Quarterly Report on Form 10-Q for the quarterly period ended March
31, 2020 filed with the SEC on May 7, 2020.
(13) Previously filed as an exhibit to the registrant’s Current Report on Form 8-K filed with the SEC on September 30,
2020.
(14) Previously filed as an exhibit to the registrant’s Quarterly Report on Form 10-Q for the quarterly period ended June
30, 2021 filed with the SEC August 5, 2021.
(15) Previously filed as an exhibit to the registrant’s Current Report on Form 8-K filed with the SEC on March 23, 2022.
(16) Previously filed as an exhibit to the registrant’s Quarterly Report on Form 10-Q for the quarterly period ended March
31, 2023 filed with the SEC May 4, 2023.
63
(17) Previously filed as an exhibit to the registrant’s Quarterly Report on Form 10-Q for the quarterly period ended June
30, 2023 filed with the SEC August 3, 2023.
(18) Previously filed as an exhibit to the registrant’s Quarterly Report on Form 10-Q for the quarterly period ended March
31, 2022 filed with the SEC May 10, 2022.
Item 16. Form 10-K Summary
None.
64
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, the registrant has
duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
SIGNATURES
COLLEGIUM PHARMACEUTICAL, INC.
By: /s/ Joseph Ciaffoni
Joseph Ciaffoni
Chief Executive Officer
Signature
Title
Date
/s/ Joseph Ciaffoni
Joseph Ciaffoni
/s/ Colleen Tupper
Colleen Tupper
President and Chief Executive Officer (Principal Executive
Officer) and Director
February 22, 2024
Executive Vice President and Chief Financial Officer (Principal
Financial and Accounting Officer)
February 22, 2024
/s/ Michael T. Heffernan, R.Ph.
Michael T. Heffernan, R.Ph.
Chairman of the Board
/s/ Rita Balice-Gordon, Ph.D.
Rita Balice-Gordon, Ph.D.
Director
/s/ Garen G. Bohlin
Garen G. Bohlin
/s/ John A. Fallon, M.D.
John A. Fallon, M.D.
/s/ John G. Freund, M.D.
John G. Freund, M.D.
/s/ Gwen Melincoff
Gwen Melincoff
/s/ Gino Santini
Gino Santini
/s/ Neil McFarlane
Neil McFarlane
Director
Director
Director
Director
Director
Director
February 22, 2024
February 22, 2024
February 22, 2024
February 22, 2024
February 22, 2024
February 22, 2024
February 22, 2024
February 22, 2024
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, this report has been signed by the
following persons in the capacities and on the dates indicated.
65
COLLEGIUM PHARMACEUTICAL, INC.
Index to Consolidated Financial Statements
Audited Consolidated Financial Statements
Report of Independent Registered Public Accounting Firm (PCAOB ID 34)
Consolidated Balance Sheets as of December 31, 2023 and 2022
Consolidated Statements of Operations for the Years Ended December 31, 2023, 2022, and 2021
Consolidated Statements of Shareholders' Equity for the Years Ended December 31, 2023, 2022, and 2021
Consolidated Statements of Cash Flows for the Years Ended December 31, 2023, 2022, and 2021
Notes to Consolidated Financial Statements
Pages
F-2
F-4
F-5
F-7
F-8
F-9
F-1
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the shareholders and the Board of Directors of Collegium Pharmaceutical, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Collegium Pharmaceutical, Inc. and subsidiaries (the
"Company") as of December 31, 2023 and 2022, the related consolidated statements of operations, comprehensive income
(loss), shareholders' equity, and cash flows, for each of the three years in the period ended December 31, 2023, and the
related notes (collectively referred to as the "financial statements"). In our opinion, the financial statements present fairly,
in all material respects, the financial position of the Company as of December 31, 2023 and 2022, and the results of its
operations and its cash flows for each of the three years in the period ended December 31, 2023, in conformity with
accounting principles generally accepted in the United States of America.
We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United
States) (PCAOB), the Company's internal control over financial reporting as of December 31, 2023, based on criteria
established in Internal Control — Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of
the Treadway Commission and our report dated February 22, 2024, expressed an unqualified opinion on the Company's
internal control over financial reporting.
Basis for Opinion
These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion
on the Company's financial statements based on our audits. We are a public accounting firm registered with the PCAOB
and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the
applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and
perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement,
whether due to error or fraud. Our audits included performing procedures to assess the risks of material misstatement of the
financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures
included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits
also included evaluating the accounting principles used and significant estimates made by management, as well as
evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our
opinion.
Critical Audit Matter
The critical audit matter communicated below is a matter arising from the current-period audit of the financial statements
that was communicated or required to be communicated to the audit committee and that (1) relates to accounts or
disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex
judgments. The communication of critical audit matters does not alter in any way our opinion on the financial statements,
taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the
critical audit matter or on the accounts or disclosures to which it relates.
Revenue Recognition – Product Return Liability – Refer to Note 3 to the Financial Statements
Critical Audit Matter Description
Revenue is recognized when control is transferred to the customer, which occurs upon delivery, and revenue is measured as
the amount of consideration the Company expects to receive in exchange for transferring products to a customer
(“transaction price”). The transaction price for product sales includes variable consideration related to sales deductions and
a refund liability is established for estimated product returns. At the end of each reporting period, the Company updates the
estimated transaction price (including updating its assessment of whether an estimate of variable consideration should be
constrained). Variable consideration, including the risk of customer concessions, is included in the transaction price only to
the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when
the uncertainty is subsequently resolved. The Company updates the measurement of the refund liability at the end of each
reporting period for changes in expectations about the amount of refunds with the corresponding adjustments recognized as
revenue (or reductions of revenue).
F-2
Estimating the variable consideration and the provision for the refund liability requires significant judgment by
management. Given the complexity and significant level of estimation uncertainty involved in calculating the refund
liability, our audit procedures in this area required a high degree of auditor judgment and an increased extent of effort.
How the Critical Audit Matter Was Addressed in the Audit
Our audit procedures related to the revenue deductions for returns and the refund liability (the “return provision”) included
the following, among others:
● We tested the effectiveness of controls over the measurement and recognition of the return provision.
● We evaluated the Company's methodology and significant assumptions made in developing the return provision.
● We tested the completeness and accuracy of the data underlying the measurement of the return provision.
● We tested the mathematical accuracy of management's underlying calculation of the return provision.
● We performed a retrospective review, comparing prior period product return estimates to actual product returns.
● We developed independent estimates of the return provision using historical sales and returns activity, product
dating and expiration dates, and other information.
/s/ Deloitte & Touche LLP
Boston, Massachusetts
February 22, 2024
We have served as the Company's auditor since 2016.
F-3
COLLEGIUM PHARMACEUTICAL, INC.
CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share data)
Assets
Current assets
Cash and cash equivalents
Marketable securities
Accounts receivable, net
Inventory
Prepaid expenses and other current assets
Total current assets
Property and equipment, net
Operating lease assets
Intangible assets, net
Restricted cash
Deferred tax assets
Other noncurrent assets
Goodwill
Total assets
Liabilities and shareholders' equity
Current liabilities
Accounts payable
Accrued liabilities
Accrued rebates, returns and discounts
Current portion of term notes payable
Current portion of operating lease liabilities
Total current liabilities
Term notes payable, net of current portion
Convertible senior notes
Operating lease liabilities, net of current portion
Total liabilities
Commitments and contingencies (refer to Note 13)
Shareholders’ equity:
Preferred stock, $0.001 par value; authorized shares - 5,000,000
Common stock, $0.001 par value; authorized shares - 100,000,000; 38,192,441
issued and 31,868,549 outstanding shares as of December 31, 2023 and
37,084,759 issued and 33,848,936 outstanding shares as of December 31, 2022
Additional paid-in capital
Treasury stock, at cost; 6,323,892 shares as of December 31, 2023 and
3,235,823 shares as of December 31, 2022
Accumulated other comprehensive income
Accumulated deficit
Total shareholders’ equity
Total liabilities and shareholders’ equity
December 31,
2023
December 31,
2022
$
$
$
$
$
$
$
238,947
71,601
179,525
32,332
15,195
537,600
15,983
6,029
421,708
1,047
26,259
825
133,857
1,143,308
8,692
37,571
227,331
183,333
988
457,915
221,713
262,125
6,124
947,877
173,688
—
183,119
46,501
16,681
419,989
19,521
6,861
567,468
2,547
23,950
100
133,695
1,174,131
3,494
36,129
230,491
162,500
1,112
433,726
397,578
140,873
7,112
979,289
—
—
38
565,949
(137,381)
14
(233,189)
195,431
1,143,308
$
37
538,073
(61,924)
—
(281,344)
194,842
1,174,131
The accompanying notes are an integral part of these consolidated financial statements.
F-4
COLLEGIUM PHARMACEUTICAL, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except share and per share data)
Product revenues, net
Cost of product revenues
Cost of product revenues (excluding intangible asset
amortization)
Intangible asset amortization and impairment
Total cost of products revenues
Gross profit
Operating expenses
Research and development
Selling, general and administrative
Restructuring
Total operating expenses
Income from operations
Interest expense
Interest income
Loss on extinguishment of debt
Income (loss) before income taxes
Provision for (benefit from) income taxes
Net income (loss)
Earnings (loss) per share — basic
Weighted-average shares — basic
Earnings (loss) per share — diluted
Weighted-average shares — diluted
Years Ended December 31,
2022
2021
2023
$
566,767 $
463,933 $
276,868
94,838
145,760
240,598
326,169
—
159,208
—
159,208
166,961
(83,339)
15,615
(23,504)
75,733
27,578
48,155 $
118,190
136,255
254,445
209,488
3,983
172,186
—
176,169
33,319
(63,213)
1,047
—
(28,847)
(3,845)
(25,002) $
59,070
67,181
126,251
150,617
9,451
118,960
4,578
132,989
17,628
(21,014)
12
—
(3,374)
(74,891)
71,517
1.43 $
(0.74) $
33,741,213
33,829,495
1.29 $
(0.74) $
41,788,125
33,829,495
2.05
34,936,817
1.86
41,045,805
$
$
$
The accompanying notes are an integral part of these consolidated financial statements.
F-5
COLLEGIUM PHARMACEUTICAL, INC.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
(In thousands)
Net income (loss)
Other comprehensive income:
Unrealized gains on marketable securities
Total other comprehensive income
Comprehensive income (loss)
$
$
Years Ended December 31,
2022
2021
2023
48,155 $
(25,002) $
14
14
48,169 $
—
—
(25,002) $
71,517
—
—
71,517
The accompanying notes are an integral part of these consolidated financial statements.
F-6
COLLEGIUM PHARMACEUTICAL, INC.
CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY
(In thousands, except share data)
Common Stock
Shares
Amount
Additional
Paid-In
Capital
Treasury Stock
Accumulated Comprehensive
Shares
Amount
Deficit
Loss
Accumulated Other
Total
Shareholders’
Equity
Balance as of
December 31, 2020
Cumulative effect of
adjustment for adoption of
ASU 2020-06
Exercise of common stock
options
Issuance for employee stock
purchase plan
Vesting of RSUs and PSUs
Shares withheld for employee
taxes upon vesting of RSUs
and PSUs
Share repurchases
Forward contract on ASR
agreement
Stock-based compensation
Net income
Balance as of
December 31, 2021
Exercise of common stock
options
Issuance for employee stock
purchase plan
Vesting of RSUs and PSUs
Shares withheld for employee
taxes upon vesting of RSUs
and PSUs
Share repurchases
Exercise of warrant
Stock-based compensation
Net loss
Balance as of
December 31, 2022
Exercise of common stock
options
Issuance for employee stock
purchase plan
Vesting of RSUs and PSUs
Shares withheld for employee
taxes upon vesting of RSUs
and PSUs
Share repurchases
Stock-based compensation
Other comprehensive
income, net of tax
Net income
Balance as of
December 31, 2023
34,612,054
$
35
$ 519,143
— $
— $
(333,147) $
— $
186,031
—
803,485
43,719
511,743
(164,882)
—
—
—
—
—
1
—
—
—
—
—
—
—
(44,777)
11,868
755
—
—
—
—
—
—
—
—
—
(4,149)
—
— (2,150,717)
—
(42,861)
5,288
—
—
—
—
—
(5,000)
24,255
—
—
—
—
—
—
—
—
—
71,517
—
—
—
—
—
—
—
—
—
(39,489)
11,869
755
—
(4,149)
(42,861)
(5,000)
24,255
71,517
35,806,119
$
36
$ 502,095
(2,150,717) $ (42,861) $
(256,342) $
— $
202,928
742,348
22,627
699,285
(226,286)
—
40,666
—
—
—
—
1
—
—
—
—
—
11,811
337
—
—
—
—
—
—
—
—
—
—
(4,044)
5,000
—
22,874
—
—
(1,085,106)
—
—
—
—
(19,063)
—
—
—
—
—
—
—
(25,002)
—
—
—
—
—
—
—
—
11,811
337
1
(4,044)
(14,063)
—
22,874
(25,002)
37,084,759
$
37
$ 538,073
(3,235,823) $ (61,924) $
(281,344) $
— $
194,842
498,008
26,505
898,817
(315,648)
—
—
—
—
—
—
1
—
—
—
—
—
8,641
460
—
—
—
—
(8,361)
—
— (3,088,069)
—
27,136
—
—
—
—
(75,457)
—
—
—
—
—
—
—
—
—
—
—
—
—
—
48,155
—
—
—
—
—
—
14
—
8,641
460
1
(8,361)
(75,457)
27,136
14
48,155
38,192,441
$
38
$ 565,949
(6,323,892) $(137,381) $
(233,189) $
14 $
195,431
The accompanying notes are an integral part of these consolidated financial statements.
F-7
COLLEGIUM PHARMACEUTICAL, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
2023
Years Ended December 31,
2022
2021
$
48,155
$
(25,002)
$
71,517
Operating activities
Net income (loss)
Adjustments to reconcile net income (loss) to net cash provided by operating activities:
Amortization and impairment expense
Depreciation expense
Deferred income taxes
Stock-based compensation expense
Non-cash lease (benefit) expense
Loss on extinguishment of debt
Non-cash interest expense for amortization of debt discount and issuance costs
Net amortization of premiums and discounts on investments
Changes in operating assets and liabilities:
Accounts receivable
Inventory
Prepaid expenses and other assets
Accounts payable
Accrued liabilities
Accrued rebates, returns and discounts
Operating lease assets and liabilities
Net cash provided by operating activities
Investing activities
Purchases of property and equipment
Purchases of marketable securities
Maturities of marketable securities
Acquisition of BDSI (net of cash acquired)
Net cash used in investing activities
Financing activities
Proceeds from issuances of common stock from employee stock purchase plans
Proceeds from the exercise of stock options
Payments made for employee stock tax withholdings
Repurchases of common stock
Repayment of term notes
Proceeds from term note modification
Proceeds from issuances of 2029 convertible notes, net of issuance costs of $6,280
Repurchase of 2026 Convertible Notes, including premium
Net cash (used in) provided by financing activities
Net increase (decrease) in cash, cash equivalents and restricted cash
Cash, cash equivalents and restricted cash at beginning of year
Cash, cash equivalents and restricted cash at end of year
Reconciliation of cash, cash equivalents and restricted cash to the Consolidated Balance
Sheets:
Cash and cash equivalents
Restricted cash
Total cash, cash equivalents and restricted cash
Supplemental disclosure of cash flow information
Cash paid for interest
Cash paid for income taxes
Supplemental disclosure of non-cash activities
Acquisition of property and equipment in accounts payable and accrued liabilities
Excise tax on share repurchases in accrued liabilities
Inventory used in the construction and installation of property and equipment
$
$
$
$
$
$
$
$
145,760
3,496
(2,153)
27,136
(280)
23,504
8,635
(1,235)
3,594
14,169
1,439
5,061
628
(3,160)
—
274,749
(461)
(92,351)
22,000
—
(70,812)
460
8,641
(8,361)
(75,000)
(162,500)
—
235,220
(138,638)
(140,178)
63,759
176,235
239,994
238,947
1,047
239,994
73,256
24,205
$
$
$
$
$
136,255
2,684
(8,391)
22,874
238
—
8,285
—
(21,780)
48,274
(4,606)
(707)
(11,131)
(22,766)
3
124,230
(1,622)
—
—
(572,069)
(573,691)
337
11,811
(4,044)
(14,063)
(75,000)
517,682
—
—
436,723
(12,738)
188,973
176,235
173,688
2,547
176,235
52,528
10,400
$
$
$
$
$
67,181
1,736
(78,042)
24,255
18
—
3,406
—
(22,524)
(2,296)
(1,086)
(5,827)
4,777
40,442
—
103,557
(1,944)
—
—
—
(1,944)
755
11,952
(4,149)
(47,861)
(50,000)
—
—
—
(89,303)
12,310
176,663
188,973
186,426
2,547
188,973
17,608
3,005
$
176
$
457
— $
— $
— $
— $
72
—
516
The accompanying notes are an integral part of these consolidated financial statements.
F-8
COLLEGIUM PHARMACEUTICAL, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(in thousands, except share and per share data)
1. Nature of Business
Organization
Collegium Pharmaceutical, Inc. (the “Company” or “Collegium”) was incorporated in Delaware in April 2002 and then
reincorporated in Virginia in July 2014. The Company has its principal operations in Stoughton, Massachusetts. The
Company’s mission is to build a leading, diversified specialty pharmaceutical company committed to improving the lives of
people living with serious medical conditions. The Company’s portfolio includes Xtampza ER, Nucynta ER and Nucynta
IR (collectively the “Nucynta Products”), Belbuca, and Symproic.
The Company’s operations are subject to certain risks and uncertainties. The principal risks include inability to continue
successfully commercializing products, changing market conditions for products and development of competing products,
changing regulatory environment and reimbursement landscape, product-related litigation, manufacture of adequate
commercial inventory, inability to secure adequate supplies of active pharmaceutical ingredients, key personnel retention,
protection of intellectual property, and patent infringement litigation.
2. Summary of Significant Accounting Policies
Basis of Accounting
The consolidated financial statements include the accounts of Collegium Pharmaceutical, Inc. as well as the accounts of its
subsidiaries Collegium Securities Corporation (a Massachusetts corporation), Collegium NF LLC (a Delaware limited
liability company), BioDelivery Sciences International, Inc. (a Delaware corporation), Arius Pharmaceuticals, Inc. (a
Delaware corporation), and Arius Two, Inc. (a Delaware corporation), all wholly owned subsidiaries requiring
consolidation. The consolidated financial statements are prepared in conformity with generally accepted accounting
principles in the United States of America (“GAAP”). All intercompany balances and transactions have been eliminated in
consolidation.
Use of Estimates
The preparation of the consolidated financial statements in accordance with GAAP requires the Company to make
estimates and assumptions that impact the reported amounts of assets, liabilities, revenues, costs and expenses and the
disclosure of contingent assets and liabilities in the Company’s consolidated financial statements and accompanying notes.
Estimates in the Company’s consolidated financial statements include revenue recognition, including the estimates of
product returns, discounts and allowances related to commercial sales of products, estimates related to the fair value of
assets acquired and liabilities assumed, including acquired intangible assets and the fair value of inventory acquired,
estimates utilized in the ongoing valuation of inventory related to potential unsalable product, estimates of useful lives with
respect to intangible assets, accounting for stock-based compensation, contingencies, impairment of intangible assets and
deferred tax valuation allowances. The Company bases estimates and assumptions on historical experience when available
and on various factors that it believes to be reasonable under the circumstances. The Company evaluates its estimates and
assumptions on an ongoing basis. The Company’s actual results may differ from these estimates under different
assumptions or conditions.
F-9
Fair Value Measurements
Fair value measurements and disclosures describe the fair value hierarchy based on three levels of inputs, of which the first
two are considered observable and the last unobservable, that may be used to measure fair value, as follows:
Level 1 inputs:
Level 2 inputs:
Level 3 inputs:
Quoted prices (unadjusted) in active markets for identical assets or liabilities. An active market is
defined as a market where transactions for the asset or liability occur with sufficient frequency
and volume to provide pricing information on an ongoing basis.
Inputs other than quoted prices included within Level 1 that are observable for the asset or
liability, either directly or indirectly. Examples of Level 2 inputs include quoted prices in active
markets for similar assets or liabilities and quoted prices for identical assets or liabilities in
markets that are not active.
Unobservable inputs that reflect the Company’s own assumptions about the assumptions market
participants would use in pricing the asset or liability.
The Company’s approach to fair value measurement is aligned with its investment policy focused on capital preservation.
The Company invests in instruments within defined credit parameters to minimize credit risk while ensuring liquidity.
There were no transfers between Levels 1, 2 and 3 during the years ended December 31, 2023 and 2022.
The following table presents the Company’s financial instruments carried at fair value using the lowest level input
applicable to each financial instrument as of December 31, 2023 and 2022.
December 31, 2023
Cash equivalents:
Money market funds
U.S. Treasury securities
Marketable securities:
Corporate debt securities
U.S. Treasury securities
Government-sponsored securities
Total assets measured at fair value
December 31, 2022
Cash equivalents:
Money market funds
Total assets measured at fair value
Total
77,299
4,729
41,612
25,468
4,521
153,629
172,590
172,590
$
$
$
$
$
$
$
$
Quoted Prices
in active
markets
(Level 1)
Significant
other
observable
inputs
(Level 2)
Significant
unobservable
inputs
(Level 3)
77,299
—
—
—
—
77,299
172,590
172,590
$
$
$
$
— $
4,729
41,612
25,468
4,521
76,330
$
— $
— $
—
—
—
—
—
—
—
—
The Company’s cash equivalents, which consist of money market funds, are measured at fair value on a recurring basis
using quoted market prices. Accordingly, these securities are categorized as Level 1.
Assets and Liabilities Not Carried at Fair Value
The Company’s convertible senior notes fall into the Level 2 category within the fair value level hierarchy. The fair value
was determined based on data points other than quoted prices that are observable, either directly or indirectly, such as
broker quotes in a non-active market. As of December 31, 2023, the fair value of the Company’s 2.625% convertible senior
notes due in 2026 was $25,033 and the net carrying value was $25,992. As of December 31, 2023, the fair value of the
Company’s 2.875% convertible senior notes due in 2029 was $249,803 and the net carrying value was $236,133.
F-10
The Company’s term notes fall into the Level 2 category within the fair value level hierarchy and the fair value was
determined using quoted prices for similar liabilities in active markets, as well as inputs that are observable for the liability
(other than quoted prices), such as interest rates that are observable at commonly quoted intervals. As of December 31,
2023, the carrying amount of the term notes reasonably approximated the estimated fair value.
As of December 31, 2023, and 2022, the carrying amounts of the cash and cash equivalents, accounts receivable, prepaid
expenses and other current assets, accounts payable, accrued liabilities, and accrued rebates, returns and discounts,
reasonably approximated the estimated fair values.
Concentration of Credit Risk
Financial instruments, which potentially subject the Company to significant concentration of credit risk, consist primarily
of cash and cash equivalents and accounts receivable. The Company maintains its cash deposits primarily with one
reputable and nationally recognized financial institution. In addition, as of December 31, 2023, the Company’s cash
equivalents were invested in money market funds. The Company has not experienced any material losses in such accounts
and management believes that the Company is not exposed to significant credit risk due to the financial position of the
financial institutions in which those deposits are held and the nature of the assets in the money market funds.
Three customers comprised 10% or more of the Company’s accounts receivable balance as of December 31, 2023. These
customers comprised 38%, 35%, and 26% of the accounts receivable balance as of December 31, 2023 and 37%, 33%, and
28% as of December 31, 2022.
The same customers comprised 10% or more of the Company’s revenue during the year ended December 31, 2023. These
customers comprised 33%, 32%, and 32% of revenue during the year ended December 31, 2023; 33%, 32%, and 31%
during the year ended December 31, 2022; and 35%, 31%, and 29% during the year ended December 31, 2021.
To date, the Company has not experienced any credit losses with respect to the collection of its accounts receivable and has
not recorded an allowance for credit losses as of December 31, 2023 or 2022. The Company has no financial instruments
with off balance sheet risk of loss.
Cash and Cash Equivalents
Cash and cash equivalents include cash in readily available checking and savings accounts, including bank deposits, and
investments in money market funds. The Company considers all highly liquid investments with an original maturity of
three months or less from the date of purchase to be cash equivalents.
Restricted Cash
Restricted cash is reported as non-current unless the restrictions are expected to be released in the next twelve months.
Restricted cash as of December 31, 2023 represents cash held in a depository account at a financial institution to
collateralize conditional standby letters of credit for the Company’s lease of its corporate headquarters and its leases of
vehicles for its field-based employees.
Marketable Securities
As of December 31, 2023, the Company’s marketable securities consisted of investments in available-for-sale corporate
debt, U.S. Treasury, and government-sponsored securities with readily determinable fair values. The Company classifies
available-for-sale marketable securities as current assets on its consolidated balance sheets. The fair value of these
securities is based on quoted prices for identical assets or inputs other than quoted prices that are observable for similar
assets, either directly or indirectly.
The Company records interest earned and net amortization of premiums and discounts on investments within interest
income on its consolidated statements of operations. The Company records unrealized gains (losses) on available-for-
F-11
sale debt securities as a component of “Accumulated other comprehensive income,” which is a separate component of
shareholders’ equity on its consolidated balance sheets, until such gains and losses are realized. Realized gains and losses
are determined using the specific identification method.
For available-for-sale debt securities with unrealized losses, the Company assesses whether a credit loss allowance is
required using an expected loss model. This process involves evaluating whether the fair value of an investment is
recoverable when compared to its amortized cost. If an increase in fair value is observed, the Company may reduce any
previously recognized credit losses. In determining whether impairments are other-than-temporary, the Company considers
its ability and intention to hold the investment until market price recovery, as well as issuer-specific credit ratings, historical
losses, and current economic conditions. The Company generally intends to retain investments until their amortized cost is
recovered and did not identify any investments with other-than-temporary impairment as of December 31, 2023.
Inventory
Inventories are stated at the lower of cost or net realizable value. Inventory costs consist of costs related to the
manufacturing of the Company’s products, which are primarily the costs of contract manufacturing and active
pharmaceutical ingredients. The Company determines the cost of its inventories on a specific identification basis and
removes amounts from inventories on a first-in, first-out basis. If the Company identifies excess, obsolete or unsalable
items, inventories are written down to their realizable value in the period in which the impairment is identified. These
adjustments are recorded based upon various factors, including the level of product manufactured by the Company, the
level of product in the distribution channel, current and projected demand and the expected shelf-life of the inventory
components.
The Company outsources the manufacturing of its products to contract manufacturers. In addition, the Company currently
relies on a sole supplier or a limited number of suppliers for the active pharmaceutical ingredients in its products.
Accordingly, the Company has concentration risk associated with its commercial manufacturing.
The Company expects to use the inventory over its operating cycle.
Business Combination Accounting and Valuation of Acquired Assets
To determine whether acquisitions should be accounted for as a business combination or as an asset acquisition, the
Company makes certain judgments regarding whether the acquired set of activities and assets meets the definition of a
business. Judgment is required in assessing whether the acquired processes or activities, along with their inputs, would be
substantive to constitute a business, as defined by U.S. GAAP.
The acquisition method of accounting requires the recognition of assets acquired and liabilities assumed at their acquisition
date fair values. Goodwill is measured as the excess of consideration transferred over the acquisition date net fair values of
the assets acquired and the liabilities assumed. The determination of the fair value requires the estimation of fair values
based on non-observable inputs that are included in valuation models. An income approach, which generally relies upon
projected cash flow models, is used in estimating the fair value of the acquired intangible assets and the fair value of
acquired inventory. These cash flow projections are based on management's estimates of economic and market conditions
including the estimated future cash flows from revenues of acquired assets, the timing and projection of costs and expenses
and the related profit margins, tax rates, and an appropriate discount rate.
F-12
Goodwill
Goodwill represents the excess of the purchase price over the estimated fair value of the net assets acquired in a business
combination. Goodwill is not amortized but is subject to impairment testing at least annually as of October 1 or when a
triggering event occurs that could indicate a potential impairment. In performing the goodwill impairment test, the
Company may first assess qualitative factors to determine whether it is more likely than not that the fair value of a
reporting unit is less than the carrying value. Alternatively, the Company may elect to proceed directly to the quantitative
impairment test. In performing the quantitative analysis, the Company compares the fair value of the reporting unit with its
carrying amount, including goodwill. If the carrying amount of the Company’s reporting unit exceeds its fair value, the
Company would recognize an impairment charge for the amount by which the carrying amount of the reporting unit
exceeds its fair value, up to the amount of goodwill allocated to that reporting unit. The Company performed a qualitative
assessment during the annual impairment review as of October 1, 2023 and concluded that it is not more likely than not that
the fair value of the Company’s reporting unit is less than its carrying amount.
Intangible Assets
The Company records the fair value of finite-lived intangible assets as of the transaction date. Intangible assets are then
amortized over their estimated useful lives using either the straight-line method, or if reliably determinable, based on the
pattern in which the economic benefit of the asset is expected to be utilized. The Company tests intangible assets for
potential impairment whenever triggering events or circumstances present an indication of impairment. If the sum of
expected undiscounted future cash flows of the intangible assets is less than the carrying amount of such assets, the
intangible assets would be written down to the estimated fair value, calculated based on the present value of expected
future cash flows.
Property and Equipment
Property and equipment, including leasehold improvements, are recorded at cost. Maintenance and repair costs are
expensed as incurred. Costs which materially improve or extend the lives of existing assets are capitalized. Property and
equipment are depreciated when placed into service using the straight-line method based on their estimated useful lives as
follows:
Asset Category
Computers and office equipment
Laboratory equipment
Furniture and fixtures
Manufacturing equipment
Leasehold improvements
Estimated Useful Life
3-5 years
5 years
7 years
5-13 years
Lesser of remaining lease term and estimated useful life
Costs for capital assets not yet placed into service have been capitalized as construction-in-progress and will be depreciated
in accordance with the above guidelines once placed into service.
Upon retirement or sale, the cost of assets disposed and the related accumulated depreciation are removed from the
accounts and any resulting gain or loss is recorded in the statements of operations.
Leases
The Company records lease assets and liabilities for lease arrangements exceeding a 12-month initial term. For operating
leases, the Company records a beginning lease liability equal to the present value of minimum lease payments to be made
over the lease term discounted using the Company’s incremental borrowing rate and a corresponding lease asset adjusted
for incentives received and indirect costs. At lease commencement, the Company measures the lease liability at the present
value of the remaining lease payments discounted using the incremental borrowing rate and the corresponding lease asset is
adjusted for incentives received and indirect costs. The Company records operating lease rent expense in the statements of
operations over the lease term. Variable lease costs are not included in the measurement of the operating lease liability and
are recognized in the period in which they are incurred. Leases with an initial term of
F-13
12 months or less, or short-term leases, are not recorded on the Company’s consolidated balance sheets. Short-term lease
expense is recognized on a straight-line basis over the lease term. The Company does not have any financing lease
arrangements.
Impairment of Long-Lived Assets
Long-lived assets consist primarily of property and equipment, operating and finance lease assets, and definite-lived
intangible assets. The Company assesses the recoverability of its long-lived assets whenever events or changes in
circumstances indicate that the carrying amount of an asset may not be recoverable. If indications of impairment exist,
projected future undiscounted cash flows associated with the asset (or asset group) would be compared to the carrying
value of the asset to determine whether the asset's value is recoverable. If impairment is determined, the Company writes
down the asset to its estimated fair value and records an impairment loss equal to the excess of the carrying value of the
long-lived asset over its estimated fair value in the period at which such a determination is made.
Revenue Recognition
The Company’s revenue to date is from sales of the Company’s products, which are primarily sold to wholesale
pharmaceutical distributors, which in turn sell the product to pharmacies for the treatment of patients. The Company
recognizes revenue when a customer obtains control of promised goods or services, in an amount that reflects the
consideration which the entity expects to receive in exchange for those goods or services. Refer to Note 3, Revenue from
Contracts with Customers, for more information.
Research and Development Costs
Research and development expenses have historically consisted of product development expenses incurred in identifying,
developing, and testing product candidates. Product development expenses primarily consisted of labor, benefits, and
related employee expenses for personnel directly involved in product development activities, fees paid to contract research
organizations for managing clinical and non-clinical trials, and regulatory costs.
As of April 1, 2022, the Company focused entirely on commercial products rather than research and development and
redirected resources from research and development activities. As such, there were no expenses incurred in research and
development after the three months ended March 31, 2022.
Advertising and Product Promotion Costs
Advertising and product promotion costs are included in selling, general and administrative expenses and were $7,406,
$11,743, and $4,186 in the years ended December 31, 2023, 2022, and 2021 respectively. Advertising and product
promotion costs are expensed as incurred.
Stock-Based Compensation
The Company accounts for grants of stock options, restricted stock units and performance share units to employees, as well
as to the Board of Directors, based on the grant date fair value and recognizes compensation expense over the vesting
period, net of actual forfeitures. For awards with service conditions, the Company recognizes compensation expense on a
straight-line basis. The Company estimates the grant date fair value of stock options using the Black-Scholes option pricing
model. The Company estimates the grant date fair value of restricted stock units based on the fair value of the underlying
common stock. For awards with performance conditions, the Company estimates the number of shares that will vest based
upon the probability of achieving performance metrics. For awards with market conditions, the Company recognizes
compensation expense on an accelerated attribution basis. The Company estimates the grant date fair value of awards with
market conditions using the Monte Carlo model.
F-14
Restructuring
During the three months ended December 31, 2021, the Company executed a plan to reduce its workforce, primarily related
to its salesforce. The arrangements included the payment of a cash severance benefit near the time of separation, together
with continued medical benefits and related services. As a result, the Company recognized $4,578 in restructuring expense.
Of this amount, $1,335 was paid by December 31, 2021 and the remaining $3,243 was paid in the first half of 2022.
Income Taxes
The Company accounts for income taxes under the liability method, which requires the recognition of deferred tax assets
and liabilities for the expected future tax consequences of events that have been included in the consolidated financial
statements. Under this method, deferred tax assets and liabilities are determined on the basis of the differences between the
financial statements and tax basis of assets and liabilities using enacted tax rates in effect for the years in which the
differences are expected to reverse. The effect of a change in tax rates on deferred tax assets and liabilities is recognized in
income in the period that includes the enactment date.
The Company recognizes net deferred tax assets to the extent that the Company believes these assets are more likely than
not to be realized. In making such a determination, management considers all available positive and negative evidence,
including future reversals of existing taxable temporary differences, projected future taxable income, tax-planning
strategies and the absence of carryback available from results of recent operations.
The Company records uncertain tax positions on the basis of a two-step process whereby: (i) management determines
whether it is more likely than not that the tax positions will be sustained on the basis of the technical merits of the position;
and (ii) for those tax positions that meet the more likely than not recognition threshold, management recognizes the largest
amount of tax benefit that is more than 50% likely to be realized upon ultimate settlement with the related tax authority.
The Company will recognize interest and penalties related to uncertain tax positions within income tax expense. Any
accrued interest and penalties will be included within the related tax liability. As of December 31, 2023, the Company had
no accrued interest or penalties related to uncertain tax positions and no amounts have been recognized in the Company’s
statements of operations.
Earnings per Share
Basic earnings per share is calculated by dividing the net income or loss by the weighted-average number of shares of
common stock outstanding during the period, without consideration for potentially dilutive securities. Diluted earnings per
share is computed by dividing the net income or loss by the weighted-average number of shares of common stock, plus
potentially dilutive securities outstanding for the period, as determined in accordance with the treasury stock, if-converted,
or contingently issuable accounting methods, depending on the nature of the security. For purposes of the diluted earnings
per share calculation, stock options, restricted stock units, performance share units, and shares potentially issuable in
connection with the employee stock purchase plan and convertible senior notes are considered potentially dilutive securities
and included to the extent that their addition is not anti-dilutive.
Embedded Derivatives
The Company accounts for derivative financial instruments as either equity or liabilities in accordance with Accounting
Standards Codification Topic 815, Derivatives and Hedging, (“ASC 815”) based on the characteristics and provisions of
each instrument. Embedded derivatives are required to be bifurcated from the host instruments and recorded at fair value if
the derivatives are not clearly and closely related to the host instruments on the date of issuance. The Company’s term notes
and convertible notes (refer to Note 14, Debt) contain certain features that, in accordance with ASC 815, are not clearly and
closely related to the host instrument and represent derivatives that are required to be re-measured at fair value each
reporting period. The Company determined that the estimated fair value of the derivatives at issuance and through
December 31, 2023 were not material based on a scenario-based cash flow model that uses unobservable inputs that reflect
the Company’s own assumptions. Should the Company’s assessment of the probabilities around these scenarios change,
including due to changes in market conditions, there could be a change to the fair value.
F-15
Recently Adopted Accounting Pronouncements
New accounting pronouncements are issued periodically by the Financial Accounting Standards Board (“FASB”) and are
adopted by the Company as required by the specified effective dates.
In August 2020, the FASB issued Accounting Standards Update (“ASU”) 2020-06, Debt - Debt with Conversion and Other
Options (Subtopic 470-20) and Derivatives and Hedging - Contracts in Entity's Own Equity (Subtopic 815-40): Accounting
for Convertible Instruments and Contracts in an Entity's Own Equity. This ASU simplifies the complexity associated with
applying U.S. GAAP for certain financial instruments with characteristics of liabilities and equity. More specifically, the
amendments focus on the guidance for convertible instruments and derivative scope exceptions for contracts in an entity’s
own equity. Under ASU 2020-06, the embedded conversion features are no longer separated from the host contract for
convertible instruments with conversion features that are not required to be accounted for as derivatives under Topic 815,
or that do not result in substantial premiums accounted for as paid-in capital. Consequently, a convertible debt instrument,
such as the Company’s convertible senior notes, will be accounted for as a single liability measured at its amortized cost, as
long as no other features require bifurcation and recognition as derivatives. The new guidance also requires the if-converted
method to be applied for all convertible instruments and requires additional disclosures.
The Company elected to early adopt this guidance on January 1, 2021 using the modified retrospective method. Under this
transition method, the cumulative effect of the accounting change was removing the impact of recognizing the equity
component of the Company’s convertible notes (at issuance and the subsequent accounting impact of additional interest
expense from debt discount amortization). The cumulative effect of the accounting change as of January 1, 2021 was an
increase to the carrying amount of the convertible notes of $39,489, a reduction to accumulated deficit of $5,288, and a
reduction to additional paid-in capital of $44,777. Interest expense of the convertible senior notes will be lower as a result
of adoption of this guidance and diluted net loss per share will be computed using the if-converted method for the
convertible senior notes. As a result of the adoption of this guidance, interest expense decreased and net income increased
by $6,488, basic earnings per share was increased by $0.19, and diluted earnings per share was decreased by $0.06 for the
year ended December 31, 2021.
In March 2020, the FASB issued ASU 2020-04, Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference
Rate Reform on Financial Reporting, to ease the potential burden in accounting for reference rate reform. The amendments
in ASU 2020-04 were elective and applied to all entities that have contracts, hedging relationships, and other transactions
that reference the London Interbank Offered Rate (“LIBOR”) or another reference rate expected to be discontinued due to
reference rate reform. The standard became effective immediately and may be applied prospectively to contracts and
transactions through December 31, 2022. Subsequent to issuance, the FASB issued ASU 2021-01, Reference Rate Reform
(Topic 848): Scope, in January 2021 to refine and clarify some of its guidance on ASU 2020-04 and ASU 2022-06,
Reference Rate Reform (Topic 848) to defer the sunset date of Topic 848 from December 31, 2022 to December 31, 2024,
after which entities will no longer be permitted to apply the relief in Topic 848. Following the cessation of LIBOR in the
United States on June 30, 2023, the Company elected to apply the optional expedient provided in FASB ASU 2020-04,
Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting
prospectively. Thus, debt previously referenced to LIBOR was transitioned to the Secured Overnight Financing Rate
(“SOFR”) effective July 1, 2023, however, such transition did not have a material effect on the Company’s consolidated
financial statements.
F-16
Recently Issued Accounting Pronouncements Not Yet Adopted
In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280). The amendments in this update
expand segment disclosure requirements, including new segment disclosure requirements for entities with a single
reportable segment among other disclosure requirements. This update is effective for fiscal years beginning after December
15, 2023, and interim periods within fiscal years beginning after December 15, 2024. The adoption of this standard is not
expected to have a material impact on the Company’s consolidated financial statements.
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740). The amendments in this update expand
income tax disclosure requirements, including additional information pertaining to the rate reconciliation, income taxes
paid, and other disclosures. This update is effective for annual periods beginning after December 15, 2024. The adoption of
this standard is not expected to have a material impact on the Company’s consolidated financial statements.
Other recent accounting pronouncements issued, but not yet effective, are not expected to be applicable to the Company or
have a material effect on the consolidated financial statements upon future adoption.
3. Revenue from Contracts with Customers
The Company’s revenue to date is from sales of the Company’s products, which are primarily sold to wholesalers
(customers), which in turn sell the product to pharmacies or other outlets for the treatment of patients.
Revenue Recognition
The Company recognizes revenue when a customer obtains control of promised goods or services, in an amount that
reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue
recognition for arrangements with a customer, the Company performs the following five steps: (i) identify the contract(s)
with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate
the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity
satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the
entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At
contract inception, the Company assesses the goods or services promised within each contract and determines those that are
performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as
revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the
performance obligation is satisfied.
The Company expenses incremental costs of obtaining a contract as and when incurred if the expected amortization period
of the assets is one year or less.
Performance Obligations
The Company determined that performance obligations are satisfied, and revenue is recognized when a customer takes
control of the Company’s product, which occurs at a point in time. This generally occurs upon delivery of the products to
customers, at which point the Company recognizes revenue and records accounts receivable. Payment is typically received
30 to 90 days after satisfaction of the Company’s performance obligations.
Transaction Price and Variable Consideration
Revenue is measured as the amount of consideration the Company expects to receive in exchange for transferring products
or services to a customer (“transaction price”). The transaction price for product sales includes variable consideration
related to sales deductions, including: (i) rebates and incentives, including managed care rebates, government rebates, co-
pay program incentives, and sales incentives and allowances; (ii) product returns, including return estimates; and (iii) trade
allowances and chargebacks, including fees for distribution services, prompt pay discounts, and chargebacks. The
Company will estimate the amount of variable consideration that should be included in the transaction price under the
expected value method for all sales deductions other than trade allowances, which are estimated under the most likely
amount method. These provisions reflect the expected amount of consideration to which
F-17
the Company is entitled based on the terms of the contract. In addition, the Company made a policy election to exclude
from the measurement of the transaction price all taxes that are assessed by a governmental authority that are imposed on
revenue-producing transactions.
The Company bases its estimates of variable consideration, which could include estimates of future rebates, returns, and
other adjustments, on historical data and other information. Estimates include: (i) timing of the rebates and returns incurred;
(ii) pricing adjustments related to rebates and returns; and (iii) the quantity of product that will be rebated or returned in the
future. Significant judgment is used in determining the appropriateness of these assumptions at each reporting period.
Rebates and Incentives
Provisions for rebates and incentives are based on the estimated amount of rebates and incentives to be claimed on the
related sales. As the Company’s rebates and incentives are based on products dispensed to patients, the Company is
required to estimate the expected value of claims at the time of product delivery to wholesalers. Given that wholesalers sell
the product to pharmacies, which in turn dispense the product to patients, claims can be submitted significantly after the
related sales are recognized. The Company’s estimates of these claims are based on the historical experience of existing or
similar programs, including current contractual and statutory requirements, specific known market events and trends,
industry data, and estimated distribution channel inventory levels. Accruals and related reserves required for rebates and
incentives are adjusted as new information becomes available, including actual claims. If actual results vary, the Company
may need to adjust future estimates, which could have an effect on earnings in the period of the adjustment.
Product Returns
Provisions for product returns, including returns for Xtampza, the Nucynta Products, Belbuca and Symproic, are based on
product-level returns rates, including processed as well as unprocessed return claims, in addition to relevant market events
and other factors. Estimates of the future product returns are made at the time of revenue recognition to determine the
amount of consideration to which the Company expects to be entitled (that is, excluding the products expected to be
returned). At the end of each reporting period, the Company analyzes trends in returns rates and updates its assessment of
variable consideration. To the extent the Company receives amounts in excess of what it expects to be entitled to receive
due to a product return, the Company does not recognize revenue when it transfers products to customers but instead
recognizes those excess amounts received as a refund liability. The Company updates the measurement of the refund
liability at the end of each reporting period for changes in expectations about the amount of refunds with the corresponding
adjustments recognized as revenue (or reductions of revenue).
The Company provides the right of return to its customers for an 18-month window beginning six months prior to
expiration and up until twelve months after expiration. The Company’s customers short-pay an existing invoice upon notice
of a product return claim. Adjustments to the preliminary short-paid claims are processed when the return claim is validated
and finalized. The Company’s return policy requires that product is returned and that the return is claimed within the 18-
month window.
2021 Returns Adjustment
Prior to the year ended December, 31, 2021, estimates of the refund liability for Xtampza product returns were based on a
combination of a limited amount of historical actual returns processed to date, taking into consideration the expiration date
of product upon delivery to customers, as well as forecasted customer buying and return patterns, channel inventory levels,
and other specifically known market events and trends. Sales of Xtampza increased significantly starting in 2018; as a
result, the majority of Xtampza sold to customers by the Company had not been eligible for return until the year ended
December 31, 2021, or beyond. For the Nucynta Products, estimates of the refund liability for product returns were based
on historical returns rates as these products have been commercially sold in the U.S. since 2009 for Nucynta IR and since
2011 for Nucynta ER. Because the Company began selling the Nucynta Products in 2018, most of the Nucynta Products
sold to customers by the Company were not eligible for return until the year ended December 31, 2021, or beyond.
F-18
During the year ended December 31, 2021, there were unprecedented and significant disruptions in the processing of
product returns. Specifically, the Company’s customers, via the third-party returns processor that they and many
pharmacies engage to process the majority of the Company’s product returns, failed to return products to the Company in
the ordinary course. The value of actual returned product during the year ended December 31, 2021 represented less than
20% of the value of the product returns claimed during that period. Due to the failure of the customers and their vendor to
return product timely in the ordinary course, the Company did not physically receive returned products corresponding to
the substantial majority of the returns claimed and could not validate or finalize customer return claims, nor determine if
the return was or would be eligible for refund upon the physical return. The lack of timely processing of requested product
returns obscures information related to the validation of product returns and increases uncertainty related to the actual
volume of product that will be physically returned and credited in accordance with the Company’s returns policy.
During the fourth quarter of 2021, after significant and sustained efforts with customers to resolve the unprocessed return
claims, the Company formally denied a significant portion of these claims under the Company’s return policy. The
Company subsequently received payment for only a portion of the denied claims and vigorously pursued collections of the
full amount of these short-pay receivables. As a result of discussions with customers related to unprocessed return claims
and the uncertainty associated with the ultimate resolution, as well as the impact of unprocessed claims on estimates of
future returns, the Company recorded an adjustment to reduce product revenues, net of $38,329, with offsetting reductions
in accounts receivable or increases in the refund liability for future product returns.
During the year ended December 31, 2022, the Company revised its estimate of variable consideration associated with
unprocessed returns claims that arose in prior periods due to the receipt of payment and settlement, which resulted in an
increase to product revenues, net of $4,684. During the year ended December 31, 2021, the Company’s adjustment was a
$26,644 reduction in product revenues.
Trade Allowances and Chargebacks
Provisions for trade allowances and chargebacks are primarily based on customer-level contractual terms. Accruals and
related reserves are adjusted as new information becomes available, which generally consists of actual trade allowances and
chargebacks processed relating to sales recognized.
At the end of each reporting period, the Company updates the estimated transaction price (including updating its
assessment of whether an estimate of variable consideration is constrained). Variable consideration, including the risk of
customer concessions, is included in the transaction price only to the extent that it is probable that a significant reversal in
the amount of cumulative revenue recognized will not occur when the uncertainty is subsequently resolved.
Significant judgment is required to determine the variable consideration included in the transaction price as described
above. Adjustments to the estimated variable consideration included in the transaction price occurs when new information
indicates that the estimate should be revised. If the value of accepted and processed claims is different than the amount
estimated and included in variable consideration, then adjustments would impact product revenues, net and earnings in the
period such revisions become known. The amount of variable consideration ultimately received and included in the
transaction price may materially differ from the Company’s estimates, resulting in additional adjustments recorded to
increase or decrease product revenues, net.
F-19
The following table summarizes activity in each of the Company’s product revenue provision and allowance categories for
the years ended December 31, 2023, 2022, and 2021, respectively:
Balance as of December 31, 2020
Provision related to current period sales
Changes in estimate related to prior period sales
Credits/payments made
Balance as of December 31, 2021
Acquired from BDSI
Provision related to current period sales
Changes in estimate related to prior period sales
Credits/payments made
Balance as of December 31, 2022
Provision related to current period sales
Changes in estimate related to prior period sales
Credits/payments made
Balance as of December 31, 2023
Rebates and
Incentives (1)
Product
Returns (2)
$
$
$
$
132,775
378,694
1,121
(370,211)
142,379
38,074
497,250
(619)
(520,147)
156,937
424,013
(4,802)
(426,322)
149,826
$
$
$
$
23,779
27,229
8,763
(5,154)
54,617
18,187
38,250
2,505
(40,005)
73,554
41,993
4,268
(42,310)
77,505
$
Trade
Allowances and
Chargebacks (3)
19,055
$
84,470
4
(90,303)
13,226
7,575
132,547
(592)
(130,698)
22,058
149,976
555
(151,672)
20,917
$
$
(1) Provisions for rebates and incentives includes managed care rebates, government rebates and co-pay program
incentives. Provisions for rebates and incentives are deducted from gross revenues at the time revenues are
recognized and are included in accrued rebates, returns and discounts in the Company’s consolidated balance
sheets.
(2) Provisions for product returns are deducted from gross revenues at the time revenues are recognized and are
included in accrued rebates, returns and discounts in the Company’s Consolidated Balance Sheets.
(3) Provisions for trade allowances and chargebacks include fees for distribution service fees, prompt pay discounts,
and chargebacks. Trade allowances and chargebacks are deducted from gross revenue at the time revenues are
recognized and are recorded as a reduction to accounts receivable in the Company’s consolidated balance sheets.
As of December 31, 2023, the Company did not have any transaction price allocated to remaining performance obligations
and any costs to obtain contracts with customers, including pre-contract costs and set up costs, were immaterial.
Disaggregation of Revenue
The Company discloses disaggregated revenue from contracts with customers into categories that depict how the nature,
amount, timing, and uncertainty of revenue and cash flows are affected by economic factors. As such, the Company
disaggregates its product revenues, net from contracts with customers by product, as disclosed in the table below.
Belbuca
Xtampza ER
Nucynta IR
Nucynta ER
Symproic
Other
Total product revenues, net
2023
Years Ended December 31,
2022
2021
$
$
182,095
177,374
108,150
82,653
16,495
—
566,767
$
$
126,461
138,804
112,058
72,418
12,267
1,925
463,933
$
$
—
103,708
102,222
70,938
—
—
276,868
The Company began recognizing revenue from net product sales of Belbuca and Symproic following the Acquisition Date
as defined in Note 4, Acquisitions.
F-20
4. Acquisitions
On March 22, 2022 (the “Acquisition Date”), the Company acquired BioDelivery Sciences International, Inc. (“BDSI”), a
specialty pharmaceutical company working to deliver innovative therapies for individuals living with serious and
debilitating chronic conditions (the “BDSI Acquisition”). Upon closing, the Company acquired Belbuca and Symproic.
The BDSI Acquisition was completed to leverage the Company’s existing sales force and other operations to
commercialize additional products that are typically marketed to similar physicians and to develop other synergies. The
Company obtained control through the acquisition of shares in an all-cash transaction which closed on March 22, 2022.
The total consideration paid for the BDSI acquisition was approximately $669,431 consisting of the following (in
thousands, except per share amounts):
Fair Value of Purchase Price Consideration
Fair value of purchase price consideration paid at closing:
Cash consideration for all outstanding shares of BDSI's common and preferred stock (103,235,298
shares acquired at $5.60 per share)
Cash consideration paid to settle RSUs and in-the-money options
Cash paid to settle BDSI debt
Total purchase consideration
Amount
$
$
578,118
28,309
63,004
669,431
The Company has accounted for the BDSI Acquisition as a business combination and, accordingly, has included the assets
acquired, liabilities assumed and results of operations in its financial statements following the Acquisition Date.
The final allocation of the consideration transferred to the assets acquired and liabilities assumed has been completed.
During the three months ended March 31, 2023, the Company recorded measurement period adjustments to increase
accrued expenses by $134 and deferred tax liabilities by $28, with a corresponding increase to goodwill of $162.
The following tables set forth the final allocation of the BDSI Acquisition purchase price to the estimated fair value of the
net assets acquired at the Acquisition Date:
Amounts Recognized at the Acquisition Date
Assets Acquired
Cash and cash equivalents
Accounts receivable
Inventory
Prepaid expenses and other current assets
Property and equipment
Operating lease assets
Intangible assets
Total assets
Liabilities Assumed
Accounts payable
Accrued liabilities
Accrued rebates, returns and discounts
Operating lease liabilities
Deferred tax liabilities
Total liabilities
Total identifiable net assets acquired
Goodwill
Total consideration transferred
$
$
$
$
$
F-21
97,362
55,495
77,382
6,125
1,242
481
435,000
673,087
12
18,249
56,261
481
62,510
137,513
535,574
133,857
669,431
The valuation of the acquired intangible assets is inherently subjective and relies on significant unobservable inputs. The
Company used an income approach to value the $435,000 of intangible assets. The valuation for each of these intangible
assets was based on estimated projections of expected cash flows to be generated by the assets, discounted to the present
value at discount rates commensurate with risk. The Company amortizes the identifiable intangible assets on a straight-line
basis over their respective useful lives (refer to Note 11, Goodwill and Intangible Assets). In addition, the acquired
inventory was recognized at its acquisition-date fair value, which resulted in an increase of $54,700 compared to its
preacquisition book value.
The excess of the purchase price over the fair value of identifiable net assets acquired represents goodwill. This goodwill is
primarily attributable to synergies of merging operations. The acquired goodwill is not deductible for tax purposes.
Total revenues attributable to BDSI from the Acquisition Date through December 31, 2022 were $140,653. However,
earnings attributable to BDSI from the Acquisition Date through December 31, 2022 are not distinguishable due to the
rapid integration of BDSI’s core operations into the Company.
Unaudited Pro Forma Summary of Operations
The following table shows the unaudited pro forma summary of operations for the years ended December 31, 2022 and
2021, as if the BDSI Acquisition had occurred on January 1, 2021. This pro forma information does not purport to
represent what the Company’s actual results would have been if the acquisition had occurred as of January 1, 2021, and is
not indicative of what such results would be expected for any future period:
Total revenues
Net income
Years Ended December 31,
2022
2021
$
$
493,284
8,674
$
$
443,571
15,015
The unaudited pro forma financial information was prepared using the acquisition method of accounting and was based on
the historical financial information of the Company and BDSI. The pro forma financial information primarily reflects the
following pro forma adjustments:
● The Company’s acquisition related transaction costs of $14,718 were reflected as of January 1, 2021;
● Employee severance related expense of $8,008 was reflected as of January 1, 2021;
● Additional amortization expense from the acquired intangibles;
● Additional cost of product revenues related to the step-up basis in inventory to record inventory at fair value; and
● Adjustments to the Company’s interest expense related to repayment of the 2020 Term Loan and entering into the
2022 Term Loan as defined in Note 14, Debt.
In addition, all of the above adjustments were adjusted for the applicable tax impact.
F-22
Acquisition Related Expenses
During the year ended December 31, 2022, the Company incurred $31,297 of acquisition related expenses as a result of the
BDSI Acquisition and the substantial majority were included in “Selling, general, and administrative” expenses in the
consolidated statements of operations. These costs include transaction costs, which primarily consisted of financial
advisory, banking, legal, and regulatory fees, and other consulting fees, incurred to complete the acquisition, employee-
related expenses (severance cost and benefits) for terminated employees after the acquisition, BDSI directors and officers
insurance, and miscellaneous other acquisition expenses incurred. The Company does not expect to incur any additional
expenses related to the BDSI Acquisition.
Transaction costs
Employee-related expenses
BDSI directors and officers insurance
Other acquisition expenses
Total acquisition related expenses
5. Licenses Agreements
Year Ended December 31, 2022
14,718
8,008
4,492
4,079
31,297
$
$
The Company periodically enters into license agreements to develop and commercialize its products.
Shionogi license and supply agreement
Prior to the BDSI Acquisition, BDSI and Shionogi Inc. (“Shionogi”) entered into an exclusive license agreement (the
“Shionogi License Agreement”) for the commercialization of Symproic in the United States including Puerto Rico (the
“Shionogi Territory”) for the treatment of opioid-induced constipation in adult patients with chronic non-cancer pain (the
“Shionogi Field”).
Pursuant to the terms of the Shionogi License Agreement, tiered royalty payments on net sales of Symproic in the Shionogi
Territory are payable quarterly based on a royalty rate that ranges from 8.5% to 17.5% (plus an additional 1% of net sales
on a pass-through basis to a third-party licensor of Shionogi) based on volume of net sales and whether Symproic is being
sold as an authorized generic. Unless earlier terminated, the Shionogi License Agreement will continue in effect until the
expiration of the royalty obligations, as defined therein. Upon expiration of the Shionogi License Agreement, all licenses
granted for Symproic in the Shionogi Field and in the Shionogi Territory survive and become fully-paid, royalty-free,
perpetual and irrevocable.
BDSI and Shionogi also had entered into a supply agreement under which Shionogi will supply Symproic at cost plus an
agreed upon markup. In the event that Symproic is sourced from a third-party supplier, Shionogi would continue to supply
naldemedine tosylate for use in Symproic manufacturing at cost plus such agreed upon markup for the duration of the
Shionogi License Agreement.
6. Earnings Per Share
Basic earnings per share is calculated by dividing the net income or loss by the weighted-average number of shares of
common stock outstanding during the period, without consideration for potentially dilutive securities. Diluted earnings per
share is computed by dividing the net income or loss by the weighted-average number of shares of common stock, plus
potentially dilutive securities outstanding for the period, as determined in accordance with the treasury stock, if-converted,
or contingently issuable accounting methods, depending on the nature of the security. For purposes of the diluted earnings
per share calculation, stock options, restricted stock units (“RSUs”), performance share units (“PSUs”), and shares
potentially issuable in connection with the employee stock purchase plan and convertible senior notes are considered
potentially dilutive securities and included to the extent that their addition is not anti-dilutive.
F-23
The following table presents the computations of basic and dilutive earnings (loss) per common share:
Numerator:
Net income (loss)
Adjustment for interest expense recognized on convertible
senior notes:
Net (loss) income — diluted
Denominator:
Weighted-average shares outstanding — basic
Effect of dilutive securities:
Stock options
Restricted stock units
Performance share units
Employee stock purchase plan
Warrants
Convertible senior notes
Weighted average shares outstanding — diluted
Earnings (loss) per share — basic
Earnings (loss) per share — diluted
Years Ended December 31,
2023
2022
2021
48,155
5,889
54,044
$
$
(25,002)
$
71,517
—
(25,002)
$
4,675
76,192
33,741,213
33,829,495
34,936,817
271,540
714,190
267,761
—
—
6,793,421
41,788,125
—
—
—
—
—
—
33,829,495
504,699
461,471
85,229
1,198
131,257
4,925,134
41,045,805
1.43
1.29
$
$
(0.74)
(0.74)
$
$
2.05
1.86
$
$
$
$
The Company has the option to settle the conversion obligation for its convertible senior notes due in 2026 and 2029 in
cash, shares or a combination of the two. The Company uses the if-converted method for the convertible senior notes.
The following table presents dilutive securities excluded from the calculation of diluted earnings per share:
Stock options
Restricted stock units
Performance share units
Employee stock purchase plan
Convertible senior notes
2023
Years Ended December 31,
2022
2021
259,405
31,050
308,680
18,591
—
1,683,805
2,047,571
447,770
—
4,925,134
1,202,403
22,605
242,714
—
—
For PSUs, these securities were excluded from the calculation of diluted earnings per share as the performance-based or
market-based vesting conditions were not met as of the end of the reporting period. All other securities presented in the
table above were excluded from the calculation of diluted earnings per share as their inclusion would have had an
antidilutive effect.
7. Marketable Securities
Available-for-sale debt securities were classified on the consolidated balance sheets at fair value as follows:
Cash and cash equivalents
Marketable securities
Total
December 31,
2023
4,729
71,601
76,330
$
$
F-24
The following table summarizes the available-for-sale securities held as of December 31, 2023:
Corporate debt securities
U.S. Treasury securities
Government-sponsored securities
Total
Gross
Unrealized
Gains
Gross
Unrealized
Losses
Amortized Cost
$
41,610
30,189
4,517
76,316
$
$
47
8
4
59
$
$
$
Fair Value
41,612
30,197
4,521
76,330
(45) $
—
—
(45) $
The following table summarizes the contractual maturities of available-for-sale securities other than investments in money
market funds as of December 31, 2023:
Matures within one year
Matures after one year through five years
Total
December 31,
2023
61,672
14,658
76,330
$
$
The Company did not record any allowances for credit losses to adjust the fair value of available-for-sale debt securities
during the year ended December 31, 2023.
The Company did not hold marketable securities as of December 31, 2022.
There were no sales of marketable securities during the year ended December 31, 2023. Net unrealized holding gains or
losses for the period that have been included in other comprehensive income were not material to the Company’s
consolidated results of operations.
8. Inventory
Inventory consisted of the following:
Raw materials
Work in process
Finished goods
Total inventory
Years Ended December 31,
2023
2022
$
$
10,384
6,740
15,208
32,332
$
$
5,600
24,672
16,229
46,501
During the years ended December 31, 2023 and 2022, the expenses related to excess and obsolete inventory that were
recorded as a component of cost of products revenues were $1,624 and $1,814, respectively. Expenses related to excess and
obsolete inventory were immaterial for the year ended December 31, 2021.
During the years ended December 31, 2023, 2022, and 2021, inventory used in the construction and installation of property
and equipment was immaterial.
F-25
9. Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets consisted of the following:
Prepaid regulatory fees
Prepaid income taxes
Prepaid co-pay program incentives
Prepaid insurance
Manufacturing deposits
Other current assets
Other prepaid expenses
Prepaid expenses and other current assets
10. Property and Equipment
Property and equipment consisted of the following:
Computers and office equipment
Laboratory equipment
Furniture and fixtures
Manufacturing equipment
Leasehold improvements
Total property and equipment
Less: accumulated depreciation
Property and equipment, net
$
$
Years Ended December 31,
2022
2023
$
$
5,938
1,416
1,758
672
2,640
93
2,678
15,195
$
$
Years Ended December 31,
2023
2022
2,388
$
436
1,133
20,643
1,061
25,661
(9,678)
15,983
$
5,614
5,138
1,907
960
—
57
3,005
16,681
2,491
436
1,133
20,910
874
25,844
(6,323)
19,521
Depreciation expense related to property and equipment amounted to $3,496, $2,684, and $1,736 for the years ended
December 31, 2023, 2022, and 2021, respectively. During the years ended December 31, 2023, 2022, and 2021 the
Company disposed of fully depreciated assets of $141, $1,040, and $96 respectively. Any gains or losses from the
retirement, sale or disposal of property and equipment during the years ended December 31, 2023, 2022, and 2021 were
immaterial.
11. Goodwill and Intangible Assets
The Company’s goodwill resulted from the BDSI Acquisition. Refer to Note 4, Acquisitions, for more information.
The following tables summarizes the changes in the carrying amount of goodwill:
Balance as of December 31, 2021
Goodwill resulting from BDSI Acquisition
Balance as of December 31, 2022
Measurement period adjustments from BDSI Acquisition
Balance as of December 31, 2023
F-26
Amount
—
133,695
133,695
162
133,857
$
$
$
The following table sets forth the cost, accumulated amortization, and carrying amount of intangible assets as of December
31, 2023 and 2022:
Amortization
Period
(Years)
As of December 31, 2023
As of December 31, 2022
Cost
Accumulated
Amortization
Carrying
Amount
Cost
Accumulated
Amortization
Carrying
Amount
Belbuca
Nucynta Products (1)
Symproic
Elyxyb
Total intangibles
4.8 $ 360,000 $
8.5
9.6
—
521,170
70,000
—
(133,821) $ 226,179 $ 360,000 $
138,460
(382,710)
57,069
(12,931)
—
—
521,170
70,000
5,000
$ 951,170 $
(529,462) $ 421,708 $ 956,170 $
(319,628)
(5,646)
(5,000)
(58,428) $ 301,572
201,542
64,354
—
(388,702) $ 567,468
The following table presents amortization and impairment expense recognized in cost of product revenues for the years
ended December 31, 2023, 2022, and 2021:
Belbuca
Nucynta Products (1)
Symproic
Elyxyb (2)
Total amortization and impairment expense
Years Ended December 31,
2022
2023
2021
$
$
75,393 $
63,082
7,285
—
145,760
$
58,428 $
67,181
5,646
5,000
136,255
$
—
67,181
—
—
67,181
(1) During the three months ended September 30, 2023, the United States Food and Drug Administration (“FDA”)
granted New Patient Population exclusivity in pediatrics for Nucynta IR which extends the period of U.S.
exclusivity for Nucynta IR to July 3, 2026, resulting in an extension of the estimated useful life of the underlying
intangible asset from 8.0 years to 8.5 years. This change in estimate resulted in a decrease of amortization
expense of $4,099 and an increase in net income of $3,037 during the year ended December 31, 2023. The impact
to earnings per share — basic and earnings per share — diluted was $0.09 and $0.07, respectively, during the year
ended December 31, 2023.
(2) Includes $214 of amortization expense and $4,786 of impairment expense.
Intangible Asset Impairment
During the three months ended December 31, 2022, the Company made the decision to discontinue the commercialization
of Elyxyb. Accordingly, an asset impairment evaluation performed during the three months ended December 31, 2022
resulted in the Company recognizing $4,786 of impairment expense related to the Elyxyb intangible asset, which was
equivalent to the carrying amount of the Elyxyb asset at the time of the impairment determination. The impairment expense
reflects that no significant proceeds are expected to be realized from its disposition. The impairment expense is included in
“Intangible asset amortization and impairment” in the consolidated statements of operations. Other expenses associated
with the discontinuation of Elyxyb were immaterial.
The revenues generated from sales of Elyxyb to date were immaterial. Elyxyb is not considered a significant component of
the entity’s business and therefore, is not presented as a discontinued operation.
There were no employees impacted by the decision to discontinue the commercialization of Elyxyb and therefore, no
severance or employee benefit expenses were recognized. In addition, contract termination costs related to the
discontinuation were immaterial and expensed upon the termination of the contracts. In February 2023, the Company
entered into the Elyxyb Sale Agreement with Scilex to transfer to Scilex all assets, rights, and obligations necessary to
commercialize Elyxyb in the United States and Canada.
F-27
As of December 31, 2023, the remaining amortization expense expected to be recognized is as follows:
Years ended December 31,
Belbuca
Nucynta
Products
Symproic
Total
2024
2025
2026
2027
2028
Thereafter
Remaining amortization expense
12. Accrued Liabilities
$
$
75,393
75,393
75,393
—
—
—
226,179
$
$
55,384
55,384
27,692
—
—
—
138,460
$
$
7,285
7,285
7,285
7,285
7,285
20,644
57,069
$
$
138,062
138,062
110,370
7,285
7,285
20,644
421,708
Accrued liabilities consisted of the following:
Accrued royalties
Accrued product taxes and fees
Accrued bonuses
Accrued interest
Accrued income taxes
Accrued payroll and related benefits
Accrued incentive compensation
Accrued sales and marketing
Accrued audit and legal
Accrued other operating costs
Total accrued liabilities
13. Commitments and Contingencies
Legal Proceedings
As of December 31,
2023
2022
14,198
5,013
4,987
2,853
2,136
1,511
1,375
1,198
700
3,600
37,571
$
$
13,770
4,352
6,347
1,410
—
1,208
1,507
2,130
1,957
3,448
36,129
$
$
From time to time, the Company may face legal claims or actions in the normal course of business. Except as disclosed
below, the Company is not currently a party to any material litigation and, accordingly, does not have any other amounts
recorded for any litigation related matters.
Xtampza ER Litigation
On March 24, 2015, Purdue sued the Company in the U.S. District Court for the District of Delaware asserting
infringement of three of Purdue’s Orange Book-listed patents (Patent Nos. 7,674,799, 7,674,800, and 7,683,072) and a non-
Orange Book-listed patent (Patent No. 8,652,497). The lawsuit was initiated in response to the Company filing the New
Drug Application (“NDA”) for Xtampza ER as a 505(b)(2) application referencing data from Purdue’s OxyContin NDA,
and under the Drug Price Competition and Patent Term Restoration Act of 1984, triggered a stay of up to 30 months before
the FDA could issue a final approval for Xtampza ER, unless the stay was earlier terminated.
The Delaware court transferred the case to the District of Massachusetts. After the Company filed a partial motion for
judgment on the pleadings relating to the Orange Book-listed patents, the District Court of Massachusetts ordered judgment
in the Company’s favor on those three patents, and dismissed the claims which lifted the 30-month stay of FDA approval.
Following this judgment, the Company obtained final approval for Xtampza ER and launched commercially.
F-28
Purdue subsequently filed two follow-on lawsuits asserting infringement of two patents that had been late-listed in the
Orange Book and, therefore, could not trigger any stay of FDA approval: Purdue asserted infringement of Patent No.
9,073,933 in November 2015 and Patent No. 9,522,919 in April 2017. In addition, Purdue invoked two non-Orange Book-
listed patents, filing suit in June 2016 asserting infringement of Patent No. 9,155,717 and in September 2017, asserting
infringement of Patent No. 9,693,961.
On March 13, 2018, the Company filed a Petition for Post-Grant Review (“PGR”) of the ʼ961 patent with the Patent Trial
and Appeal Board (“PTAB”). The PGR argued that the ʼ961 patent is invalid.
On November 21, 2017, the Court issued its claim construction ruling, construing certain claims of the ʼ933, ʼ497, and ʼ717
patents. The Court issued an order on September 28, 2018, in which it ruled that the Xtampza ER formulation does not
infringe the ʼ497 and ʼ717 patents.
On September 15, 2019, Purdue commenced chapter 11 bankruptcy proceedings in the United States Bankruptcy Court for
the Southern District of New York. Later in September 2019, Purdue gave the District Court of Massachusetts, as well as
the PTAB, notice of its bankruptcy filing and sought the imposition of an automatic stay of proceedings. Both the Court and
the PTAB granted Purdue’s requests to stay the pending matters.
On September 1, 2020, the Bankruptcy Court entered an Order, lifting the automatic stays in both the District of
Massachusetts and PTAB proceedings. On September 11, 2020, Purdue filed a motion to terminate the PTAB action on the
basis that those proceedings had gone beyond the 18-month statutory period. On November 19, 2021, the PTAB: (i) denied
Purdue’s motion to terminate the PGR; and (ii) issued its Final Written Decision, finding that the asserted claims of the
ʼ961 patent were invalid for lack of written description and anticipation. Purdue appealed the decision to Federal Circuit,
which issued its decision on November 21, 2023, affirming the authority of the PTAB to issue its Final Written Decision
and upholding the PTAB’s finding of invalidity relative to the ’961 patent.
On April 2, 2021, the Court granted Purdue’s Motion to Lift the Stay in the District of Massachusetts that was entered
following Purdue’s Notice of Bankruptcy. On April 9, 2021, Purdue filed another follow-on lawsuit asserting infringement
of U.S. Patent No. 10,407,434. The Company responded to Purdue’s complaint with a motion to dismiss. On May 21, 2021,
and in response to the Company’s motion to dismiss, Purdue filed an amended complaint. The Company renewed its
motion to dismiss on June 4, 2021, arguing: (i) Purdue cannot, as a matter of law, state a claim for infringement under §
271(e)(2)(A); (ii) Purdue cannot, as a matter of law, state a claim for product-by-process infringement under §271(g); and
(iii) Purdue has not alleged facts sufficient to support any indirect infringement theory under §271(b) or (c). The Court held
a hearing on the Company’s motion to dismiss on October 13, 2021, and the motion is pending before the Court.
Like the prior follow-on lawsuits, the ’434 patent litigation was consolidated into the lead case and a scheduling order was
entered. On May 15, 2023, the Court issued an order that: (i) vacated the existing deadlines with respect to the ʼ933, ʼ919,
and ʼ434 patents and stayed the case pending the Federal Circuit’s decision in a different litigation that invalidated certain
claims of the ʼ933 and ʼ919 patents; and (ii) continued the existing stay concerning the ʼ961 patent pending resolution of
Purdue’s appeal rights relating to the decision invalidating the claims of the ʼ961 patent. The Court has not set a deadline
for dispositive motions or trial.
The remaining patents-in-suit in the lead consolidated action in the District of Massachusetts are the ʼ933, ʼ919, ʼ434, and
ʼ961 patents. Purdue has made a demand for monetary relief, and requested a judgment of infringement, an adjustment of
the effective date of FDA approval, and an injunction on the sale of the Company’s products accused of infringement. The
Company has denied all claims and has requested a judgment that the remaining asserted patents are invalid and/or not
infringed; the Company is also seeking a judgment that the case is exceptional and has requested an award of the
Company’s attorneys’ fees for defending the case.
The Company plans to defend this case vigorously. At this stage, the Company is unable to evaluate the likelihood of an
unfavorable outcome or estimate the amount or range of potential loss, if any.
F-29
Nucynta Litigation
On February 7, 2018, Purdue filed a patent infringement suit against the Company in the U.S. District Court for the District
of Delaware, in which it argues that the Company’s sale of immediate-release and extended-release Nucynta infringes U.S.
Patent Nos. 9,861,583, 9,867,784, and 9,872,836. On December 6, 2018, the Company filed an Amended Answer asserting
an affirmative defense for patent exhaustion. On December 10, 2018, the Court granted the parties’ stipulation for
resolution of the Company’s affirmative defense of patent exhaustion and stayed the action, with the exception of briefing
on and resolution of the Company’s Motion for Judgment on the Pleadings related to patent exhaustion and any discovery
related to that Motion.
Also, on December 10, 2018, the Company filed a Rule 12(c) Motion for Judgment on the Pleadings, arguing that Purdue’s
claims were barred by the doctrine of patent exhaustion. On June 19, 2019, the Court issued an order calling for discovery
on a factual predicate for the patent exhaustion defense and noted that the case remained “stayed with the exception of
discovery and briefing on and resolution of the Company’s anticipated motion for summary judgment based on patent
exhaustion.”
On September 19, 2019, Purdue notified the Court of its bankruptcy filing and sought an automatic stay of proceedings,
which was granted. The Nucynta litigation currently remains subject to the bankruptcy stay.
The Company plans to defend this case vigorously. At this stage, the Company is unable to evaluate the likelihood of an
unfavorable outcome or estimate the amount or range of potential loss, if any.
Opioid Litigation
As a result of the opioid epidemic, numerous state and local governments and other entities brought suit against
manufacturers, distributors, and pharmacies alleging a variety of claims related to opioid marketing and distribution
practices. In late 2017, the U.S. Judicial Panel on Multidistrict Litigation ordered the consolidation of cases pending around
the country in federal court against opioid manufacturers and distributors into a Multi-District Litigation (“MDL”) in the
Northern District of Ohio. The Company was initially named as a defendant in 21 of the MDL cases. By April 19, 2022, all
MDL cases naming the Company were dismissed or withdrawn.
Outside of the MDL, several cases were filed against the Company in Arkansas, Pennsylvania, and Massachusetts state
courts with allegations similar to those in the MDL related to opioid marketing and distribution practices, as well as
allegations including violations of state consumer protections laws.
On March 21, 2019, the Arkansas state court litigation was dismissed. On December 24, 2021, the Company entered into a
settlement framework with Scott+Scott Attorneys at Law, LLP, the law firm representing plaintiffs in 27 jurisdictions filed
either in Pennsylvania and Massachusetts state courts, or filed in other state courts and removed to the MDL. Pursuant to
the terms of the settlement, the Company paid $2,750 in exchange for dismissal, with prejudice, of each plaintiff’s lawsuit
and a release of claims related to such lawsuits. The Company is currently dismissed from all cases.
The Company settled to efficiently resolve these litigations and did not admit any liability or acknowledge any wrongdoing
in connection with the settlement.
Opioid-Related Request and Subpoenas
The Company, like several other pharmaceutical companies, has received subpoenas or civil investigative demands related
to opioid sales and marketing practices, from the Offices of the Attorney General of Washington, New Hampshire,
Maryland, and Massachusetts.
On December 16, 2021, the Company entered into an Assurance of Discontinuance with the Massachusetts Attorney
General’s Office. The Company is currently cooperating with each of the remaining states in their respective investigations.
F-30
Aquestive Litigation
On September 22, 2014, Reckitt Benckiser, Inc., Indivior PLC (formerly RB Pharmaceuticals Limited, “Indivior”), and
Aquestive Therapeutics, Inc. (formerly MonoSol Rx, “Aquestive”) (collectively, the “RB Plaintiffs”) filed an action in the
District Court in the District of New Jersey alleging patent infringement against BDSI related to its Bunavail product. The
RB Plaintiffs claimed that Bunavail, whose formulation and manufacturing processes have never been disclosed publicly,
infringed U.S. Patent No. 8,765,167 (the “’167 Patent”).
On January 13, 2017, Aquestive filed a complaint in the District Court for the District of New Jersey against BDSI alleging
Belbuca also infringed the ’167 Patent. On March 8, 2023, the parties filed a stipulation of dismissal after agreeing to settle
the dispute. Under the terms of the settlement agreement, BDSI resolved both the Bunavail and Belbuca litigations in
exchange for a one-time, lump-sum payment of $8,500 to Aquestive, which was recognized as an expense included in
“selling, general and administrative expenses” in the consolidated statements of operations for the year ended December
31, 2023.
Litigation Related to the BDSI Acquisition
On February 25, 2022, in connection with the BDSI Acquisition, a purported individual stockholder of BDSI filed a
complaint in the District Court for the Southern District of New York naming as defendants BDSI and each member of its
Board of Directors as of the date of the Merger Agreement (“Stein Action”). On February 28, 2022, two additional cases
were filed by purported individual stockholders of BDSI in the same court: the “Sanford Action” and the “Higley Action.”
In March 2022, two additional cases were filed by purported individual stockholders of BDSI in the District Court for the
Eastern District of New York: the “Justice Action” and the “Zomber Action” (together with the Stein, Sanford, and Higley
Actions, the “Actions”). The Actions and any similar subsequently filed cases involving BDSI, its officers or Board of
Directors, or any committee thereof, and/or any of the Company’s officers or directors relating directly or indirectly to the
Merger Agreement, the BDSI Acquisition or any related transaction, are referred to as the “Merger Litigations.”
The Merger Litigations filed to date generally allege that the Schedule 14D-9 is materially incomplete and misleading. The
Merger Litigations assert violations of Section 14(e) of the Exchange Act and violations of Section 20(a) of the Exchange
Act against BDSI’s Board of Directors. The Merger Litigations seek, among other things: an injunction enjoining
consummation of the Merger, rescission of the Merger Agreement, a declaration that BDSI and its Board of Directors
violated Sections 14(e) and 20(a) of the Exchange Act and Rule 14a-9 promulgated thereunder, damages, costs of the
action, including plaintiffs’ attorneys’ fees and experts’ fees and expenses, and any other relief the court may deem just and
proper.
In addition, between February and March of 2022, BDSI received demand letters from three purported stockholders of
BDSI seeking to inspect certain books and records of BDSI related to the Merger (collectively, the “Inspection Letters”). In
March 2022, BDSI received demand letters from four purported stockholders alleging that the Schedule 14D-9 omits
purportedly material information relating to the Merger (collectively, the “Demand Letters”).
Plaintiffs in the Higley, Zomber, and Justice Actions each filed a notice of voluntary dismissal of their complaint in the
second quarter of 2022. On July 28, 2022, plaintiff in the Sanford Action filed a partial voluntary dismissal of the
individual named defendants, and on October 26, 2022, filed a notice of voluntary dismissal of the BDSI defendant. On
February 17, 2023, the Stein Action was dismissed.
While the Company believes that the remaining Merger Litigations, Inspection Letters, and Demand Letters are without
merit and that the disclosures in the Schedule 14D-9 comply fully with applicable law, solely in order to avoid the expense
and distraction of litigation, BDSI previously determined to voluntarily supplement the Schedule 14D-9 with certain
supplemental disclosures set forth in BDSI’s Schedule 14D-9 filed with the SEC on March 11, 2022 (the “Supplemental
Disclosures”). The Company and BDSI believe that the Supplemental Disclosures mooted all allegations or concerns raised
in the Merger Litigations, Inspection Letters, and Demand Letters.
F-31
Alvogen
On September 7, 2018, BDSI filed a complaint for patent infringement in District Court for the District of Delaware against
Alvogen Pb Research & Development LLC, Alvogen Malta Operations Ltd., Alvogen Pine Brook LLC, Alvogen,
Incorporated, and Alvogen Group, Incorporated (collectively, “Alvogen”), asserting that Alvogen infringed BDSI’s Orange
Book-listed patents for Belbuca, including U.S. Patent Nos. 8,147,866, 9,655,843 and 9,901,539 (collectively, “the BEMA
patents”). This complaint followed receipt by BDSI on July 30, 2018 of a Paragraph IV Patent Certification from Alvogen
stating it had filed an abbreviated New Drug Application (“ANDA”) with the FDA for a generic version of Belbuca Buccal
Film in strengths 75 mcg, 150 mcg, 300 mcg, 450 mcg, 600 mcg, 750 mcg and 900 mcg.
A three-day bench trial was held from March 1-3, 2021. On December 20, 2021, the Court issued an opinion upholding the
validity of certain claims in BDSI’s ʼ866 patent and certain claims in the ’539 patent. The Court entered final judgment on
January 21, 2022 upholding the validity of claims of the ’866 and ’539 patents and thereby extended the effective date of
any final approval by the FDA of Alvogen’s ANDA until December 21, 2032, (the expiration date of the ’539 patent) and
enjoining Alvogen from commercially launching its ANDA products until December 21, 2032. Alvogen filed a motion to
stay certain provisions of the final judgment. BDSI filed an opposition to Alvogen’s request for a stay. The Court retained
jurisdiction to decide BDSI’s motion for contempt, which was filed on September 21, 2021.
Alvogen filed a notice of appeal to the Federal Circuit seeking to reverse the Court’s final judgment. Separately, BDSI filed
a cross-appeal to the Federal Circuit seeking to reverse the Court’s opinion that claims 3 and 10 of the ʼ866 patent and
claims 8, 9 and 20 of the ’843 patent are invalid and thus, Alvogen is not liable for infringement of those claims, as well as
any other ruling decided adversely to BDSI. On December 21, 2022, the Federal Circuit affirmed the district court
judgment that certain claims of the ʼ866 and ʼ539 patent were not invalid as obvious. The Federal Circuit also vacated the
district court’s judgment that certain claims of the ʼ866 and ʼ843 patent were invalid as obvious and remanded to the district
court for further proceedings. The mandate issued on February 10, 2023.
As it has done in the past, the Company intends to vigorously defend its intellectual property against assertions of invalidity
or non-infringement.
Chemo Research, S.L.
On March 1, 2019, BDSI filed a complaint for patent infringement in the District Court for the District of Delaware against
Chemo Research, S.L., Insud Pharma S.L., IntelGenx Corp., and IntelGenx Technologies Corp. (collectively, the “Chemo
Defendants”), asserting that the Chemo Defendants infringe the BEMA patents. This complaint followed receipt by BDSI
on January 31, 2019, of a Notice Letter from Chemo Research S.L. stating that it had filed with the FDA an ANDA
containing a Paragraph IV Patent Certification, for a generic version of Belbuca Buccal Film in strengths 75 mcg, 150 mcg,
300 mcg, 450 mcg, and 900 mcg.
Chemo agreed to be bound by the decision of the Court with respect to the validity of the BEMA patents as disputed
between BDSI and Alvogen. Accordingly, the December 20, 2021 ruling of the Court upholding the validity of certain
claims of the BEMA patents is binding upon Chemo. In March 2022, the Court vacated the bench trial set to begin April
25, 2022 to address the remaining Chemo infringement claims. The Court has not yet set a new trial date.
On August 1, 2022, BDSI received a second Paragraph IV certification notice letter from Chemo indicating it amended its
ANDA to: (i) withdraw its generic version of the 75 mcg and 150 mcg strengths of Belbuca; and (ii) include its generic
version of the 600 mcg and 750 mcg strengths of Belbuca, in addition to the 300 mcg, 450 mcg, and 900 mcg strengths
identified in the first Chemo Paragraph IV certification notice letter. In response, BDSI filed a complaint for patent
infringement in Federal District Court for the District of Delaware. Chemo answered the complaint on December 1, 2022.
The Court has not yet set a schedule for this litigation.
On August 24, 2022, the Court instructed the parties to update the Court at such time as the FDA addresses Chemo's July
29, 2022 response to the FDA. On February 8, 2023, the Court denied Chemo’s request for a trial date in the spring, and
F-32
again instructed the parties to update the Court at such time as the FDA addresses Chemo’s July 29, 2022 response to the
FDA. Chemo received a complete response letter with respect to its July 29, 2022 ANDA in April 2023. Chemo submitted
a further amended ANDA to FDA in September 2023.
The Company plans to litigate this case vigorously. At this stage, the Company is unable to evaluate the likelihood of an
unfavorable outcome or estimate the amount or range of potential loss, if any.
14. Debt
2020 Term Loan
On February 6, 2020, in connection with the execution of the Nucynta Purchase Agreement, the Company, together with its
subsidiary, Collegium Securities Corporation, entered into a loan agreement (the “2020 Loan Agreement”) with BioPharma
Credit PLC, as collateral agent and lender, and BioPharma Credit Investments V (Master) LP, as lender (collectively
“Pharmakon”). The 2020 Loan Agreement provided for a $200,000 secured term loan (the “2020 Term Loan”), the
proceeds of which were used to finance a portion of the purchase price paid pursuant to the Nucynta Purchase Agreement.
On February 13, 2020 (the “2020 Term Loan Closing Date”), the Company received the $200,000 proceeds from the 2020
Term Loan.
On March 22, 2022 the outstanding balance under the 2020 Loan Agreement was fully paid in connection with the closing
of the BDSI Acquisition and establishment of the 2022 Term Loan, as described below.
2022 Term Loan
On March 22, 2022, in connection with the closing of the BDSI Acquisition, the Company entered into an Amended and
Restated Loan Agreement by and among the Company, and BioPharma Credit PLC, as collateral agent and lender, and
BioPharma Credit Investments V (Master) LP, as lender (collectively “Pharmakon”), as amended (the “2022 Loan
Agreement”). The 2022 Loan Agreement provided for a $650,000 secured term loan (the “2022 Term Loan”), the proceeds
of which were used to repay the Company’s existing term notes and fund a portion of the consideration to be paid to
complete the BDSI Acquisition. The 2022 Loan Agreement was accounted for as a debt modification and transaction fees
of $173 were expensed. In connection with the 2022 Loan Agreement, the Company paid loan commitment and other fees
to the lender of $19,818, which together with preexisting debt issuance costs and note discounts of $2,049 will be
amortized over the term of the loan using the effective interest rate.
The 2022 Term Loan will mature on the 48-month anniversary of the closing of the BDSI Acquisition and is guaranteed by
the Company’s material domestic subsidiaries. The 2022 Term Loan is also secured by substantially all of the assets of the
Company and its material domestic subsidiaries. Prior to the cessation of LIBOR on June 30, 2023, the 2022 Term Loan
bore interest at a rate based on LIBOR (subject to a LIBOR floor of 1.20%), plus a margin of 7.5% per annum. On June 23,
2023, the Company entered into an amendment to the 2022 Loan Agreement to adjust the interest terms of the 2022 Term
Loan to transition from LIBOR to SOFR in anticipation of the cessation of LIBOR. Effective July 1, 2023, the 2022 Term
Loan bears interest at a rate based on SOFR plus a spread adjustment of 0.26% (subject to a floor of 1.20%), plus a margin
of 7.5% per annum. As of December 31, 2023, the contractual interest rate was 13.2%. The Company paid $100,000 in
principal payments under the 2022 Term Loan during the first year and the remaining $550,000 balance is required to be
paid in equal quarterly installments over the remaining three years.
The 2022 Loan Agreement permits voluntary prepayment at any time, subject to a prepayment premium. The prepayment
premium is equal to 2.00% of the principal amount being prepaid prior to the second-year anniversary of the closing date,
or 1.00% of the principal amount being prepaid on or after the second-year anniversary of the closing date. The 2022 Loan
Agreement also includes a make-whole premium in the event of a voluntary prepayment, a prepayment due to a change in
control or acceleration following an Event of Default (as defined in the 2022 Loan Agreement) on or prior to the second-
year anniversary of the closing date, in each case in an amount equal to foregone interest from the date of prepayment
through the second-year anniversary of the closing date. A change of control also triggers a mandatory prepayment of the
2022 Term Loan.
F-33
The 2022 Loan Agreement contains certain covenants and obligations of the parties, including, without limitation,
covenants that limit the Company’s ability to incur additional indebtedness or liens, make acquisitions or other investments
or dispose of assets outside the ordinary course of business. Failure to comply with these covenants would constitute an
Event of Default under the 2022 Loan Agreement, notwithstanding the Company’s ability to meet its debt service
obligations. The 2022 Loan Agreement also includes various customary remedies for the lenders following an Event of
Default, including the acceleration of repayment of outstanding amounts under the 2022 Loan Agreement and execution
upon the collateral securing obligations under the 2022 Loan Agreement.
The following table presents the total interest expense recognized related to the 2020 Term Loan and 2022 Term Loan
during the years ended December 31, 2023, 2022, and 2021:
Contractual interest expense
Amortization of debt issuance costs
Total interest expense
$
$
67,499
7,468
74,967
$
$
51,155
7,378
58,533
$
$
13,834
2,505
16,339
2023
Years Ended December 31,
2022
2021
As of December 31, 2023, the effective interest rate on the 2022 Term Loan was 14.7%.
As of December 31, 2023, principal repayments under the 2022 Term Loan are as follows:
Years ended December 31,
Principal Payments
2024
2025
2026
Total before unamortized discount and issuance costs
Less: unamortized discount and issuance costs
Total term notes
2026 Convertible Notes
$
$
$
183,333
183,333
45,834
412,500
(7,454)
405,046
On February 13, 2020, the Company issued 2.625% convertible senior notes due in 2026 (the “2026 Convertible Notes”) in
the aggregate principal amount of $143,750, in a public offering registered under the Securities Act of 1933, as amended.
The 2026 Convertible Notes were issued in connection with funding the acquisition of the Nucynta Products. Some of the
Company’s existing investors participated in the 2026 Convertible Notes offering.
In connection with the issuance of the 2026 Convertible Notes, the Company incurred approximately $5,473 of debt
issuance costs, which primarily consisted of underwriting, legal and other professional fees.
The 2026 Convertible Notes are senior unsecured obligations and bear interest at a rate of 2.625% per year payable semi-
annually in arrears on February 15 and August 15 of each year, beginning on August 15, 2020. Before August 15, 2025,
noteholders will have the right to convert their notes only upon the occurrence of certain events. From and after August 15,
2025, noteholders may convert their notes at any time at their election until the close of business on the scheduled trading
day immediately before the maturity date. The Company will settle conversions by paying or delivering, as applicable,
cash, shares of the Company’s common stock or a combination of cash and shares of the Company’s common stock, at the
Company’s election. The 2026 Convertible Notes will mature on February 15, 2026, unless earlier repurchased, redeemed
or converted. The initial conversion rate is 34.2618 shares of common stock per $1 principal amount of the 2026
Convertible Notes, which represents an initial conversion price of approximately $29.19 per share of common stock. The
conversion rate and conversion price are subject to adjustment upon the occurrence of certain events.
F-34
Holders of the 2026 Convertible Notes may convert all or any portion of their 2026 Convertible Notes, in multiples of $1
principal amount, at their option only under the following circumstances:
(1) during any calendar quarter commencing after the calendar quarter ending on March 31, 2020, if the last
reported sale price per share of the Company’s common stock exceeds 130% of the conversion price for at
least 20 trading days during the 30 consecutive trading days ending on, and including, the last trading day of
the immediately preceding calendar quarter;
(2) during the five consecutive business days immediately after any 10 consecutive trading day period (such 10
consecutive trading day period, the “measurement period”) in which the “trading price” per $1 principal
amount of the 2026 Convertible Notes for each trading day of the measurement period was less than 98% of
the product of the last reported sale price per share of the Company’s common stock on such trading day and
the conversion rate on such trading day;
(3) upon the occurrence of certain corporate events or distributions on the Company’s common stock;
(4) if the Company calls the 2026 Convertible Notes for redemption; or
(5) at any time from, and including, August 15, 2025 until the close of business on the scheduled trading day
immediately before the maturity date.
As of December 31, 2023, none of the above circumstances had occurred and as such, the 2026 Convertible Notes could
not have been converted.
The Company did not have the right to redeem the 2026 Convertible Notes prior to February 15, 2023. On or after February
15, 2023, the Company may redeem the 2026 Convertible Notes, in whole and not in part, at a cash redemption price equal
to the principal amount of the 2026 Convertible Notes to be redeemed, plus accrued and unpaid interest, if any, only if the
last reported sale price per share of the Company’s common stock exceeds 130% of the conversion price on:
(1) each of at least 20 trading days, whether or not consecutive, during the 30 consecutive trading days ending on,
and including, the trading day immediately before the date the Company sends the related redemption notice; and
(2) the trading day immediately before the date the Company sends such notice.
Calling any 2026 Convertible Notes for redemption will constitute a make-whole fundamental change, in which case the
conversion rate applicable to the conversion of any 2026 Convertibles Notes, if converted in connection with the
redemption, will be increased in certain circumstances for a specified period of time.
The 2026 Convertible Notes have customary default provisions, including: (i) a default in the payment when due (whether
at maturity, upon redemption or repurchase upon fundamental change or otherwise) of the principal of, or the redemption
price or fundamental change repurchase price for, any note; (ii) a default for 30 days in the payment when due of interest
on any note; (iii) a default in the Company’s obligation to convert a note in accordance with the indenture, if such default is
not cured within 3 calendar days after its occurrence; (iv) a default with respect to the Company’s obligations under the
indenture related to consolidations, mergers and asset sales; (v) a default in any of the Company’s other obligations or
agreements under the indenture that are not cured or waived within 60 days after notice to the Company; (vi) certain
payment defaults by the Company or certain subsidiaries with respect to mortgages, agreements or other instruments for
indebtedness for money borrowed of at least $20,000 or other defaults by the Company or certain subsidiaries with respect
to such indebtedness that result in the acceleration of such indebtedness; (vii) default upon the occurrence of one or more
final judgments being rendered against the Company or any of the Company's significant subsidiaries for the payment of at
least $20,000; and (viii) certain events of bankruptcy, insolvency and reorganization with respect to the Company or any of
its significant subsidiaries.
Repurchase of a Portion of the 2026 Convertible Notes
Contemporaneously with the offering of the 2029 Convertible Notes (as defined below), the Company entered into separate
privately negotiated transactions with certain holders of the 2026 Convertible Notes to repurchase $117,400 aggregate
principal amount of the 2026 Convertible Notes for an aggregate of $140,100 of cash, which includes accrued
F-35
and unpaid interest on the 2026 Convertible Notes to be repurchased. This transaction involved a contemporaneous
exchange of cash between the Company and holders of the 2026 Convertible Notes participating in the issuance of the 2029
Convertible Notes. Accordingly, the Company evaluated the transaction for modification or extinguishment accounting in
accordance with Accounting Standards Codification Topic 470-50, Debt – Modifications and Extinguishments on a
creditor-by-creditor basis depending on whether the exchange was determined to have substantially different terms. The
repurchase of the 2026 Convertible Notes and issuance of the 2029 Convertible Notes were deemed to have substantially
different terms based on the present value of the cash flows immediately prior to and after the exchange. Therefore, the
repurchase of the 2026 Convertible Notes was accounted for as a debt extinguishment. The Company recorded a $23,504
loss on early extinguishment of debt on the consolidated statements of operations during the three months ending March
31, 2023, which includes the recognition of previously deferred financing costs of $2,264. The total remaining principal
amount outstanding under the 2026 Convertible Notes as of December 31, 2023 was $26,350.
2029 Convertible Notes
On February 10, 2023, the Company issued 2.875% convertible senior notes due in 2029 (the “2029 Convertible Notes”) in
the aggregate principal amount of $241,500, in a private offering to qualified institutional buyers pursuant to Section 4(a)
(2) and Rule 144A under the Securities Act of 1933, as amended. The 2029 Convertible Notes were issued to finance the
concurrent repurchase of a portion of the 2026 Convertible Notes, and the remainder of the net proceeds may be used for
general corporate purposes. In connection with the issuance of the 2029 Convertible Notes, the Company incurred
approximately $6,280 of debt issuance costs, which primarily consisted of underwriting, legal and other professional fees.
The 2029 Convertible Notes are senior, unsecured obligations and bear interest at a rate of 2.875% per year payable semi-
annually in arrears on February 15 and August 15 of each year, beginning on August 15, 2023. The 2029 Convertible Notes
will mature on February 15, 2029, unless earlier repurchased, redeemed or converted. Before November 15, 2028,
noteholders will have the right to convert their notes only upon the occurrence of certain events. From and after November
15, 2028, noteholders may convert their notes at any time at their election until the close of business on the scheduled
trading day immediately before the maturity date. The Company will settle conversions by paying or delivering, as
applicable, cash, shares of the Company’s common stock or a combination of cash and shares of the Company’s common
stock, at the Company’s election. The initial conversion rate is 27.3553 shares of common stock per $1 principal amount of
2029 Convertible Notes, which represents an initial conversion price of approximately $36.56 per share of common stock.
The conversion rate and conversion price are subject to adjustment upon the occurrence of certain events.
Holders of the 2029 Convertible Notes may convert all or any portion of their 2029 Convertible Notes, in multiples of $1
principal amount, at their option only under the following circumstances:
(1) during any calendar quarter commencing after the calendar quarter ending on June 30, 2023, if the last reported
sale price per share of the Company’s common stock exceeds 130% of the conversion price for at least 20 trading
days during the 30 consecutive trading days ending on, and including, the last trading day of the immediately
preceding calendar quarter;
(2) during the five consecutive business days immediately after any 10 consecutive trading day period (such 10
consecutive trading day period, the “measurement period”) in which the “trading price” per $1 principal amount
of the 2029 Convertible Notes for each trading day of the measurement period was less than 98% of the product
of the last reported sale price per share of the Company’s common stock on such trading day and the conversion
rate on such trading day;
(3) upon the occurrence of certain corporate events or distributions on the Company’s common stock;
(4) if the Company calls any or all of the 2029 Convertible Notes for redemption, but only with respect to the 2029
Convertible Notes called for redemption; or
(5) at any time from, and including, November 15, 2028 until the close of business on the scheduled trading day
immediately before the maturity date.
As of December 31, 2023, none of the above circumstances had occurred and as such, the 2029 Convertible Notes could
not have been converted.
F-36
The Company may not redeem the 2029 Convertible Notes prior to February 17, 2026. On or after February 17, 2026 and
on or before the 40th scheduled trading day before the maturity date, the Company may redeem the 2029 Convertible
Notes, in whole or in part, at a cash redemption price equal to the principal amount of the 2029 Convertible Notes to be
redeemed, plus accrued and unpaid interest, if any, only if the last reported sale price per share of the Company’s common
stock exceeds 130% of the conversion price on:
(1) each of at least 20 trading days, whether or not consecutive, during the 30 consecutive trading days ending on,
and including, the trading day immediately before the date the Company sends the related redemption notice; and
(2) the trading day immediately before the date the Company sends such notice.
However, the Company may not redeem less than all of the outstanding 2029 Convertible Notes unless at least $75,000
aggregate principal amount of the 2029 Convertible Notes are outstanding and not called for redemption as of the time the
Company sends the related redemption notice.
Calling any 2029 Convertible Note for redemption will constitute a make-whole fundamental change with respect to that
2029 Convertible Note, in which case the conversion rate applicable to the conversion of that 2029 Convertible Note, if it is
converted in connection with the redemption, will be increased in certain circumstances for a specified period of time.
The 2029 Convertible Notes have customary default provisions, including: (i) a default in the payment when due (whether
at maturity, upon redemption or repurchase upon fundamental change or otherwise) of the principal of, or the redemption
price or fundamental change repurchase price for, any note; (ii) a default for 30 days in the payment when due of interest on
any note; (iii) a default in the Company’s obligation to convert a note in accordance with the indenture, if such default is
not cured within 3 business days after its occurrence; (iv) a default with respect to the Company’s obligations under the
indenture related to consolidations, mergers and asset sales; (v) a default in any of the Company’s other obligations or
agreements under the indenture that are not cured or waived within 60 days after notice to the Company; (vi) certain
payment defaults by the Company or certain subsidiaries with respect to mortgages, agreements or other instruments for
indebtedness for money borrowed of at least $30,000 or other defaults by the Company or certain subsidiaries with respect
to such indebtedness that result in the acceleration of such indebtedness; (vii) default upon the occurrence of one or more
final judgments being rendered against the Company or any of the Company’s significant subsidiaries for the payment of at
least $30,000; and (xiii) upon the occurrence of certain events of bankruptcy, insolvency and reorganization with respect to
the Company or any of its significant subsidiaries.
The 2026 Convertible Notes and 2029 Convertible Notes (together, the “Convertible Notes”) are classified on the
consolidated balance sheets as of December 31, 2023 as convertible senior notes.
As of December 31, 2023, the Convertible Notes outstanding consisted of the following:
Principal
Less: unamortized issuance costs
Net carrying amount
2026 Convertible Notes 2029 Convertible Notes Total Convertible Notes
267,850
$
(5,725)
262,125
241,500
(5,367)
236,133
26,350
(358)
25,992
$
$
$
$
$
The Company determined the expected life of the 2026 Convertible Notes and 2029 Convertible Notes was equal to the
six-year term of each. The effective interest rate on the 2026 Convertible Notes and 2029 Convertible Notes is 3.34% and
3.28%, respectively. As of December 31, 2023, the if-converted value did not exceed the remaining principal amount of the
Convertible Notes.
F-37
The following table presents the total interest expense recognized related to the Convertible Notes during the years ended
December 31, 2023, 2022, and 2021:
Contractual interest expense
Amortization of debt issuance costs
Total interest expense
$
$
7,206
1,166
8,372
$
$
3,773
907
4,680
$
$
3,773
902
4,675
2023
Years Ended December 31,
2022
2021
As of December 31, 2023, the future minimum payments on the Convertible Notes were as follows:
Years ended December 31,
2024
2025
2026
2027
2028
Thereafter
Total minimum payments
Less: interest
Less: unamortized issuance costs
Convertible Notes carrying value
15. Leases
Operating Lease Arrangements
2026 Convertible Notes
692
$
692
26,696
—
—
—
28,080
(1,730)
(358)
25,992
$
$
2029 Convertible Notes
6,943
$
6,943
6,943
6,943
6,943
244,972
279,687
(38,187)
(5,367)
236,133
$
$
Total Convertible Notes
7,635
$
7,635
33,639
6,943
6,943
244,972
307,767
(39,917)
(5,725)
262,125
$
$
The Company's main operating lease is for its corporate headquarters in Stoughton, Massachusetts, which was entered into
in March 2018 and commenced in August 2018. This lease encompasses approximately 50,678 square feet and is for an
initial 10-year term, with options for two additional five-year extensions. The initial annual base rent is $1,214, subject to
annual increases between 2.5% to 3.1%.
As of December 31, 2023, the Company's operating lease assets totaled $6,029 and operating lease liabilities amounted to
$7,112. This primarily relates to the corporate headquarters lease, with other immaterial operating and embedded operating
leases accounted for in the normal course of business.
Short-Term Lease Arrangements
In December 2018, the Company began entering into 12-month, non-cancelable vehicle leases for its field-based
employees. Each vehicle lease is executed separately and expires at varying times with automatic renewal options that are
cancelable at any time. The rent expense for these leases is recognized on a straight-line basis over the lease term in the
period in which it is incurred.
Variable Lease Costs
Variable lease costs primarily include utilities, property taxes, and other operating costs that are passed on from the lessor.
F-38
The components of lease cost for the years ended December 31, 2023, 2022, and 2021 are as follows:
Years Ended December 31,
2022
2023
2021
Operating lease cost
Short-term lease cost
Variable lease cost
Total lease cost
$
$
1,306
1,446
565
3,317
$
$
1,805
993
331
3,129
$
$
1,305
1,492
292
3,089
The lease term and discount rate for operating leases for the years ended December 31, 2023 and 2022 are as follows:
Weighted-average remaining lease term — operating leases (years)
Weighted-average discount rate — operating leases
Years Ended December
31,
2023
5.7
6.2%
2022
6.6
6.2%
Other information related to operating leases for the years ended December 31, 2023, 2022, and 2021 is as follows:
Cash paid for amounts included in the measurement of operating leases liabilities
Leased assets obtained in exchange for new operating lease liabilities
$
Years Ended December 31,
2021
2022
2023
1,286
1,568
1,585
—
—
—
$
$
The Company’s aggregate future minimum lease payments for its operating leases, including embedded operating lease
arrangements, as of December 31, 2023, are as follows:
Years ended December 31,
Lease Payments
2024
2025
2026
2027
2028
Thereafter
Total minimum lease payments
Less: Present value discount
Present value of lease liabilities
16. Equity
Common Stock
$
$
$
1,398
1,436
1,474
1,489
1,527
1,169
8,493
1,381
7,112
In May 2015, the Company adopted the Amended and Restated 2014 Stock Incentive Plan (the “Plan”), under which an
aggregate of 2,700,000 shares of common stock were authorized for issuance to employees, officers, directors, consultants
and advisors of the Company, plus an annual increase on the first day of each fiscal year until the expiration of the Plan
equal to 4% of the total number of outstanding shares of common stock on December 31st of the immediately preceding
calendar year (or a lower amount as otherwise determined by the Company’s Board of Directors prior to January 1st). As of
December 31, 2023, there were 1,876,424 shares of common stock available for issuance pursuant to the Plan. The Plan
provides for granting of both Internal Revenue Service qualified incentive stock options and non-qualified options,
restricted stock awards, restricted stock units and performance stock units. The Company’s qualified incentive stock
options, non-qualified options and restricted stock units generally vest ratably over a four-year period of service. The stock
options generally have a ten-year contractual life and, upon termination, vested options are generally exercisable between
one and three months following the termination date, while unvested options are forfeited
F-39
immediately upon termination. Shares issued under all of the Company’s plans are funded through the issuance of new
shares. Refer to Note 17, Stock-based Compensation, for more information.
Warrants
In connection with execution of the Third Amendment to the Nucynta Commercialization Agreement, the Company issued
a warrant to Assertio Therapeutics, Inc. to purchase 1,041,667 shares of common stock of the Company (the “Warrant”) at
an exercise price of $19.20 per share. The Warrant was set to expire in November 2022 and included customary
adjustments for changes in the Company’s capitalization. In November 2022, the Warrant was exercised through a cashless
exercise and the Company issued 40,666 shares. As of December 31, 2023, there were no outstanding warrants remaining.
Share Repurchases
Prior Repurchase Program
In August 2021, the Company’s Board of Directors authorized the repurchase of up to $100,000 of shares of its common
stock at any time or times through December 31, 2022 (the “Prior Repurchase Program”). The Prior Repurchase Program
permitted the Company to effect repurchases through a variety of methods, including open-market purchases (including
pursuant to a trading plan adopted in accordance with Rule 10b5-1 of the Exchange Act), privately negotiated transactions,
or otherwise in compliance with Rule 10b-18 of the Exchange Act.
In October 2021, the Company’s Board of Directors authorized an accelerated share repurchase (“ASR”) program to
repurchase $25,000 of the Company’s common stock, as part of the Company’s $100,000 Prior Repurchase Program.
Under the terms of the Company's ASR agreement with an investment bank, the Company paid $25,000 on November 15,
2021, and initially received 1,026,694 shares, representing 80% of the upfront payment on a price per share of $19.48, the
closing price on the date the agreement was executed. The remaining shares purchased by the Company were based on the
volume-weighted average price of its common stock through January 7, 2022, minus an agreed upon discount between the
parties. On January 7, 2022, the ASR agreement settled and the Company received an additional 307,132 shares, bringing
the total shares repurchased pursuant to the ASR agreement to 1,333,826.
The ASR agreement was accounted for as two distinct transactions: (1) an immediate repurchase of common stock,
recorded as a treasury stock transaction, and (2) a forward contract indexed to the Company’s own stock. The forward
contract, which represented the remaining shares to be delivered by the investment bank, was recorded as a reduction to
stockholders’ equity and was still outstanding as of December 31, 2021.
The Prior Repurchase Program expired on December 31, 2022. Through December 31, 2022, the Company repurchased
3,235,823 shares at a weighted-average price of $19.14 per share for a total of $61,924 under the Prior Repurchase
Program. Repurchased shares were returned to the Company’s pool of authorized but unissued shares. The cost of
repurchased shares were recorded as treasury stock in the consolidated balance sheet. Shares repurchased under the Prior
Repurchase Program resulted in an immediate reduction of shares outstanding used to calculate the weighted-average
common shares outstanding for both basic and diluted earnings per share. As the Company was entitled to receive
additional shares of its common stock in connection with the outstanding forward contracts, the receipt of additional shares
of common stock was antidilutive. Therefore, no adjustments were made in the computation of earnings per share for the
period the forwards were outstanding.
2023 Repurchase Program
In January 2023, the Company’s Board of Directors authorized the repurchase of up to $100,000 of shares of its common
stock at any time or times through December 31, 2023 (the “2023 Repurchase Program”). The 2023 Repurchase Program
permitted the Company to effect repurchases through a variety of methods, including open-market purchases (including
pursuant to a trading plan adopted in accordance with Rule 10b5-1 of the Exchange Act), privately negotiated transactions,
or otherwise in compliance with Rule 10b-18 of the Exchange Act.
F-40
In July 2023, the Company’s Board of Directors authorized an ASR program to repurchase $50,000 of the Company’s
common stock, as part of the Company’s $100,000 2023 Repurchase Program. Under the terms of the Company's ASR
agreement with an investment bank, the Company paid $50,000 on August 7, 2023, and received 1,702,852 shares,
representing 80% of the upfront payment on a price per share of $23.49, the closing price on the date the agreement was
executed. The remaining shares purchased by the Company were based on the volume-weighted average price of its
common stock through October 31, 2023, minus an agreed upon discount between the parties. In October 2023, the ASR
agreement settled and the Company received an additional 462,442 shares, bringing the total shares repurchased pursuant
to the ASR agreement to 2,165,294.
In November 2023, the Company’s Board of Directors authorized a second ASR program as part of the Company’s
$100,000 2023 Repurchase Program to repurchase $25,000 of the Company’s common stock. Under the terms of the
Company's ASR agreement with an investment bank, the Company paid $25,000 on November 9, 2023, and received
865,426 shares, representing 80% of the upfront payment on a price per share of $23.11, the closing price on the date the
agreement was executed. The remaining shares purchased by the Company were based on the volume-weighted average
price of its common stock through December 29, 2023, minus an agreed upon discount between the parties. In December
2023, the ASR agreement settled and the Company received an additional 57,349 shares, bringing the total shares
repurchased pursuant to the ASR agreement to 922,775.
Each ASR agreement was accounted for as two distinct transactions: (1) an immediate repurchase of common stock,
recorded as a treasury stock transaction, and (2) a forward contract indexed to the Company’s own stock. The forward
contracts, which represented the remaining shares to be delivered by the investment bank, were recorded as a reduction to
stockholders’ equity. Both forward contracts associated with these ASR agreements were settled and not outstanding as of
December 31, 2023.
The 2023 Repurchase Program expired on December 31, 2023. Through December 31, 2023, the Company repurchased
3,088,069 shares at a weighted-average price of $24.29 per share for a total of $75,000 under the 2023 Repurchase
Program. Repurchased shares were returned to the Company’s pool of authorized but unissued shares. The cost of
repurchased shares were recorded as treasury stock in the consolidated balance sheet. Shares repurchased under the 2023
Repurchase Program resulted in an immediate reduction of shares outstanding used to calculate the weighted-average
common shares outstanding for both basic and diluted earnings per share. As the Company was entitled to receive
additional shares of its common stock in connection with the outstanding forward contracts, the receipt of additional shares
of common stock was antidilutive. Therefore, no adjustments were made in the computation of earnings per share for the
period the forwards were outstanding.
2024-2025 Repurchase Program
In January 2024, the Company’s Board of Directors authorized the repurchase of up to $150,000 of the Company’s
common stock through June 30, 2025 (the “2024-2025 Repurchase Program”). The 2024-2025 Repurchase Program
permits the Company to effect repurchases through a variety of methods, including open-market purchases (including
pursuant to a trading plan adopted in accordance with Rule 10b5-1 of the Exchange Act), privately negotiated transactions,
or otherwise in compliance with Rule 10b-18 of the Exchange Act. The timing and amount of any shares purchased on the
open market will be determined based on the Company’s evaluation of the market conditions, share price and other factors.
The Company plans to utilize existing cash on hand to fund share repurchases.
17. Stock-based Compensation
Performance Share Units, Restricted Stock Units and Stock Options
Performance Share Units
The Company periodically grants PSUs to certain members of the Company's senior management team. PSUs vest subject
to the satisfaction of annual and cumulative performance and/or market conditions established by the Compensation
Committee.
F-41
In January 2019, the Company granted PSUs with performance conditions related to 2019, 2020, 2021 and three-
year cumulative revenue goals for Xtampza ER. The PSUs were to vest following a three-year performance period, subject
to the satisfaction of the performance criteria and the executive’s continued employment through the performance period.
PSUs may vest in a range between 0% and 200%, based on the satisfaction of performance criteria, and no shares will be
issued if the minimum applicable performance metric is not achieved. The Company recognizes compensation expense
ratably over the required service period based on its estimate of the number of shares that will vest based upon the
probability of achieving the performance metrics. During the year ended December 31, 2021, the Company adjusted
cumulative compensation expense based on the number of shares that vested.
Beginning in February 2020 and each year thereafter, the Company granted PSUs with performance criteria related to the
relative ranking of the total stockholder return (“TSR”) of the Company’s common stock for each individual year within a
three-year performance period as well as the cumulative three-year performance period return relative to the TSR of certain
peer companies within the S&P Pharmaceutical Select Industry Index. TSR will be measured based on the 30-day average
stock price on the first day of each period compared to the 30-day average stock price on the last day of each period. The
PSUs subject to the annual performance criteria will vest annually, subject to the satisfaction of the performance criteria
and the executive’s continued employment through the performance period. The cumulative PSUs will vest following
the three-year performance period, subject to the satisfaction of the performance criteria and the executive’s continued
employment through the performance period. PSUs may vest in a range between 0% and 200%, based on the satisfaction of
performance, and no shares will be issued if the minimum applicable performance metric is not achieved. As these PSUs
vest based on the achievement of market conditions, the grant date fair values were determined using a Monte-Carlo
valuation model. The Monte-Carlo valuation model considered a variety of potential future share prices for the Company as
well as its peer companies in the selected market index.
A summary of the Company’s PSUs activity for the year ended December 31, 2023 and related information is as follows:
Outstanding as of December 31, 2022
Granted
Vested
Forfeited
Performance adjustment
Outstanding as of December 31, 2023
Shares
Weighted-Average
Grant Date Fair Value
447,770
216,500
(223,170)
—
62,780
503,880
$
$
28.71
38.71
27.99
—
27.14
33.13
The number of PSUs awarded represents the target number of shares of common stock that may be earned; however, the
actual number of shares earned may vary based on the satisfaction of performance criteria. The weighted-average grant
date fair value of PSUs granted for the years ended December 31, 2023, 2022, and 2021 was $38.71, $24.12, and $35.15,
respectively.
For the years ended December 31, 2023, 2022, and 2021, the stock-based compensation expense for PSUs was $7,037,
$5,398, and $4,817 respectively.
As of December 31, 2023, the unrecognized compensation cost related to performance share units was $5,585 and is
expected to be recognized as expense over approximately 1.6 years.
Restricted Stock Units
A summary of the Company’s RSUs activity for the year ended December 31, 2023 and related information is as follows:
F-42
Outstanding as of December 31, 2022
Granted
Vested
Forfeited
Outstanding as of December 31, 2023
Shares
Weighted-Average
Grant Date Fair Value
2,047,571
1,278,256
(675,647)
(206,273)
2,443,907
$
$
19.67
26.25
19.83
21.91
22.88
The weighted-average grant date fair value of RSUs granted for the years ended December 31, 2023, 2022, and 2021 was
$26.25, $17.53, and $24.23, respectively. The total fair value of RSUs vested (measured on the date of vesting) for the
years ended December 31, 2023, 2022, and 2021 was $17,677, $10,166, and $11,165, respectively.
As of December 31, 2023, the unrecognized compensation cost related to restricted stock units was $37,022 and is expected
to be recognized as expense over approximately 2.6 years. The weighted-average grant date fair value of restricted stock
units vested during the years ended December 31, 2023, 2022, and 2021 was $13,398, $12,547, and $8,526, respectively.
Stock Options
A summary of the Company’s stock option activity for the year ended December 31, 2023 and related information is as
follows:
Outstanding as of December 31, 2022
Exercised
Cancelled
Outstanding as of December 31, 2023
Exercisable as of December 31, 2023
Weighted-
Average
Exercise Price
per Share
Weighted-
Average
Remaining
Contractual
Term (in years)
18.84
17.34
18.90
19.48
19.45
5.5
4.3
4.3
$
$
$
Aggregate
Intrinsic
Value
7,953
13,297
13,120
Shares
1,683,805
(498,008)
(9,047)
1,176,750
1,158,209
$
$
$
The weighted-average assumptions used in the Black-Scholes option pricing model to determine the fair value of the
employee stock option grants were as follows:
Risk-free interest rate
Volatility
Expected term (years)
Expected dividend yield
2023
Years Ended December 31,
2022
2021
— %
— %
—
— %
— %
— %
—
— %
0.7 %
67.2 %
6.0
— %
Risk-free Interest Rate. The risk-free interest rate assumption is based on observed interest rates appropriate for the
expected term of the stock option grants.
Expected Volatility. Due to the Company’s limited operating history and lack of company-specific historical or implied
volatility, the expected volatility assumption is based on the Company’s volatility as well as the historical volatilities of a
peer group of similar companies whose share prices are publicly available. The peer group was developed based on
companies in the biotechnology and pharmaceutical industries. In evaluating similarity, the Company considers factors
such as industry, stage of life cycle and size.
F-43
Expected Term. The expected term represents the period of time that options are expected to be outstanding. Because the
Company does not have historical exercise behavior through December 31, 2021, it determined the expected term
assumption using the simplified method, which is an average of the contractual term of the option and its vesting period.
Expected Dividend Yield. The expected dividend yield assumption is based on the fact that the Company has never paid
cash dividends and has no present intention to pay cash dividends.
The Company did not grant stock options during the years ended December 31, 2023 and 2022. The weighted-average
grant date fair value of stock options granted for the year ended December 31, 2021 was $12.60. The total intrinsic value of
stock options exercised for the years ended December 31, 2023, 2022, and 2021 was $4,786, $3,943, and $6,456,
respectively.
As of December 31, 2023, the unrecognized compensation cost related to outstanding options was $110 and is expected to
be recognized as expense over approximately 0.2 years.
Employee Stock Purchase Plan
The Company’s 2015 Employee Stock Purchase Plan allows employees as designated by the Company’s Board of
Directors to purchase shares of the Company’s common stock. The purchase price is equal to 85% of the lower of the
closing price of the Company’s common stock on: (i) the first day of the purchase period; or (ii) the last day of the purchase
period. During the year ended December 31, 2023, 26,505 shares of common stock were purchased for total proceeds of
$460. As of December 31, 2023, there were 2,244,157 shares of common stock authorized for issuance pursuant to the
employee stock purchase plan. The expense for the years ended December 31, 2023, 2022 and 2021 was $209, $117 and
$224 respectively.
Stock-Based Compensation Expense
Stock-based compensation for all stock options, restricted stock awards, restricted stock units, performance share units and
for the employee stock purchase plan are reported within the following:
Research and development
Selling, general and administrative
Total stock-based compensation expense
18. Income Taxes
Years Ended December 31,
2023
2022
2021
$
$
— $
27,136
27,136
$
1,591 $
21,283
22,874
$
3,422
20,833
24,255
The provision for (benefit from) income taxes contained the following components:
Current provision:
Federal
State
Deferred benefit:
Federal
State
Provision for (benefit from) income taxes
2023
Years Ended December 31,
2022
2021
21,504
8,227
29,731
(1,401)
(752)
(2,153)
27,578
$
$
$
166
4,540
4,706
(4,631)
(3,920)
(8,551)
(3,845)
$
$
$
—
3,142
3,142
(61,445)
(16,588)
(78,033)
(74,891)
$
$
$
F-44
A reconciliation of income tax expense (benefit) computed at the statutory federal income tax rate to income taxes as
reflected in the consolidated financial statements is as follows:
Federal income tax expense at statutory rate
Change resulting from:
State income tax, net of federal benefit
Permanent difference - debt extinguishment
Permanent differences - all other
Stock compensation
Research and development credit
Transaction costs
Change in tax rates and other
Change in valuation allowance
Effective income tax rate
Years Ended December 31,
2022
2021
2023
21.0 %
21.0 %
21.0 %
4.9
7.1
1.3
1.0
—
—
0.4
0.7
36.4 %
5.0
—
(1.9)
(5.1)
0.7
(4.4)
(2.0)
—
13.3 %
2.9
—
(3.9)
(18.8)
16.3
—
—
2,202.5
2,220.0 %
During the year ended December 31, 2023, the effective tax rate was impacted by permanent differences, including the
extinguishment of debt in connection with the repurchase of a portion of the Company’s 2026 Convertible Notes, for which
certain extinguishment costs were not deductible for tax purposes. Stock compensation, including the impact of excess
benefits and 162(m) limitations, impacted the effective tax rate at varying percentages each year due to changes in the non-
deductible amount and profit before tax. In addition, during the year ended December 31, 2022, non-deductible transaction
costs resulting from the BDSI Acquisition impacted the effective tax rate. During the year ended December 31, 2021, the
Company released the valuation allowance on the majority of its net operating losses, resulting in a significant discrete
deferred tax benefit that impacted the effective tax rate.
Deferred taxes are recognized for temporary differences between the basis of assets and liabilities for financial statement
and income tax purposes. The significant components of the Company’s deferred tax assets and liabilities are comprised of
the following:
Deferred tax assets:
U.S. and state net operating loss carryforwards
Research and development credits
Operating lease liabilities
Returns and discounts
Stock-based compensation
Accruals and other
163(j) Carryforward
Capitalized R&D
Intangible assets
Gross deferred tax assets:
Valuation allowance
Total deferred tax assets:
Deferred tax liabilities:
Debt discount
Operating lease assets
Inventory
Intangible assets
Property and equipment
Total deferred tax liabilities:
Net deferred tax assets
F-45
Years Ended December 31,
2023
2022
$
33,800
1,769
1,803
18,528
7,570
6,257
—
707
32,771
103,205
(5,781)
97,424
(344)
(1,529)
—
(65,774)
(3,518)
(71,165)
26,259
$
$
56,982
5,036
2,131
19,423
6,776
5,228
3,647
929
23,592
123,744
(5,254)
118,490
(406)
(1,778)
(3,918)
(84,167)
(4,271)
(94,540)
23,950
$
The Company provides a valuation allowance when it is more-likely-than-not that deferred tax assets will not be realized.
In determining the extent to which a valuation allowance for deferred tax assets is required, the Company evaluates all
available evidence including projections of future taxable income, carryback opportunities, reversal of certain deferred tax
liabilities, and other tax planning strategies. The Company maintains a partial valuation against its federal and state
operating losses and federal R&D credits as of December 31, 2023. The valuation allowance was $5,781 and $5,254 as of
December 31, 2023 and 2022, respectively, and reflects limitations based on the Company’s ability to use such assets prior
to expiration. The change in the valuation allowance increased the tax provision by $527 for the year ended December 31,
2023. The change in valuation allowance did not impact the tax provision for the year ended December 31, 2022. As a
result of sustained positive earnings history through cumulative earnings over the prior three years, as of June 30, during
the year ended December 31, 2021, the Company began using projections of future taxable income as a source of realizing
its deferred tax assets. Accordingly, the Company recognized a deferred tax benefit of $78,042 for the year ended
December 31, 2021 related to the reversal of valuation allowances.
The Tax Cuts and Jobs Act of 2017 (“TCJA”) will generally allow losses incurred after 2017 to be carried over indefinitely
but will generally limit the net operating loss (“NOL”) deduction to the lesser of the NOL carryover or 80% of a
corporation’s taxable income (subject to Internal Revenue Code Sections 382 and 383). Also, there will be no carryback for
losses incurred after 2017. Losses incurred prior to 2018 will generally be deductible to the extent of the lesser of a
corporation’s NOL carryover or 100% of a corporation’s taxable income (subject to Internal Revenue Code Section 382 and
383) and be available for twenty years from the period the loss was generated. As of December 31, 2023, the Company had
gross U.S. federal net operating loss carryforwards of $137,459, of which $95,471 arose prior to 2018, which are available
to offset future taxable income, if any, through 2037. The remaining $41,988 are available for an indefinite period. As of
December 31, 2022, the Company had gross U.S. federal net operating loss carryforwards of $229,797.
As of December 31, 2023 and 2022, the Company also had gross U.S. state net operating loss carryforwards of $202,381
and $252,597, respectively, which may be available to offset future income tax liabilities and expire at various dates
through 2037.
As of December 31, 2023 and 2022, the Company had federal research and development tax credit carryforwards of
approximately $1,025 and $4,231, respectively, available to reduce future tax liabilities which expire at various dates
through 2032. As of December 31, 2023 and 2022, the Company had state research and development tax credit
carryforwards of approximately $672 and $832, respectively, available to reduce future tax liabilities which expire at
various dates through 2036.
The Company has completed studies to assess the impact of ownership changes, if any, on the Company’s ability to use its
NOL and tax credit carryovers as defined under Section 382 of the Internal Revenue Code (“IRC 382”). The Company
concluded that there were ownership changes that occurred during the years 2006, 2012 and 2015 that would be subject to
IRC 382 limitations. The Company acquired $234,675 of net operating loss carryforward from the BDSI Acquisition. The
Company concluded that there were ownership changes for BDSI that occurred during the years 2006 and 2022 that would
be subject to IRC 382 limitations. These IRC 382 annual limitations may limit the Company’s ability to use pre-ownership
change federal NOL carryovers and pre-ownership change federal tax credit carryovers. As of December 31, 2023,
remaining net operating losses of $124,310 are subject to limitation.
The Company files income tax returns in the United States and in several states. The federal and state income tax returns
are generally subject to tax examinations for the tax years ended December 31, 2019 through December 31, 2023. To the
extent the Company has tax attribute carryforwards, the tax years in which the attribute was generated may still be adjusted
upon examination by the Internal Revenue Service or state tax authorities to the extent utilized in a future period.
F-46
The Company has not recognized deferred tax assets for certain federal and state research and development credits related
to uncertain tax positions, and that is included in the tabular rollforward of uncertain tax positions. A reconciliation of the
beginning and ending amount of gross unrecognized tax benefits (“UTB”) is as follows:
Gross UTB Balance as of January 1
Additions based on tax positions related to the current year
Additions for tax positions related to acquisitions
(Reductions) additions for tax positions of prior years
Gross UTB Balance as of December 31
Net UTB impacting the effective tax rate as of December 31
excluding valuation allowance impacts, if any
19. Employee Benefits
Years Ended December 31,
2023
2022
$
$
$
11,400
—
—
(94)
11,306
11,275
$
$
$
654
—
10,930
(184)
11,400
11,368
$
$
$
2021
586
67
—
1
654
500
The Company has a retirement savings plan, which is qualified under section 401(k) of the Code, for its employees. The
plan allows eligible employees to defer, at the employee’s discretion, pretax compensation up to the Internal Revenue
Service annual limits. Employees become eligible to participate starting on the first day of employment. The Company is
not required to contribute to this plan. Total expense for contributions made by the Company for the years ended December
31, 2023, 2022 and 2021 was $1,759, $1,315, and $1,236, respectively.
F-47
20. Unaudited Quarterly Operating Results
The following is a summary of unaudited quarterly results of operations for the years ended December 31, 2023 and 2022:
Year Ended December 31, 2023
Product revenues, net
Cost of product revenues
Cost of product revenues (excluding intangible
asset amortization)
Intangible asset amortization and impairment
Total cost of products revenues
Gross profit
Operating expenses
Selling, general and administrative
Total operating expenses
Income from operations
Interest expense
Interest income
Loss on extinguishment of debt
(Loss) income before income taxes
(Benefit from) provision for income taxes
Net (loss) income
(Loss) earnings per share — basic
Weighted-average shares — basic
(Loss) earnings per share — diluted
Weighted-average shares — diluted
First
Quarter
Second
Quarter
Third
Quarter
Fourth
Quarter
$
144,767
$
135,546
$
136,709
$
149,745
29,899
37,466
67,365
77,402
52,775
52,775
24,627
(21,427)
2,747
(23,504)
(17,557)
(131)
(17,426) $
24,257
37,463
61,720
73,826
38,193
38,193
35,633
(21,863)
4,027
—
17,797
4,790
13,007
(0.51) $
34,319,291
0.38
34,622,284
(0.51) $
34,319,291
0.34
42,849,952
20,081
36,317
56,398
80,311
35,298
35,298
45,013
(20,768)
4,538
—
28,783
8,149
20,634
0.61
33,744,209
0.53
42,058,821
20,601
34,514
55,115
94,630
32,942
32,942
61,688
(19,281)
4,303
—
46,710
14,770
31,940
0.99
32,301,211
0.82
41,279,981
$
$
$
$
$
$
$
$
$
F-48
Year Ended December 31, 2022
Product revenues, net
Cost of product revenues
Cost of product revenues (excluding intangible
asset amortization)
Intangible asset amortization and impairment
Total cost of products revenues
Gross profit
Operating expenses
Research and development
Selling, general and administrative
Total operating expenses
(Loss) income from operations
Interest expense
Interest income
(Loss) income before income taxes
(Benefit from) provision for income taxes
Net (loss) income
(Loss) earnings per share — basic
Weighted-average shares — basic
(Loss) earnings per share — diluted
Weighted-average shares — diluted
First
Quarter
Second
Quarter
Third
Quarter
Fourth
Quarter
$
83,751
$
123,549
$
127,013
$
129,620
16,332
18,923
35,255
48,496
3,983
54,528
58,511
(10,015)
(5,831)
4
(15,842)
(2,773)
(13,069) $
33,684
37,501
71,185
52,364
—
41,254
41,254
11,110
(17,761)
5
(6,646)
(1,455)
(5,191) $
30,622
37,552
68,174
58,839
—
38,372
38,372
20,467
(19,046)
11
1,432
975
457
(0.39) $
(0.15) $
33,673,912
34,001,553
(0.39) $
(0.15) $
33,673,912
34,001,553
0.01
34,058,802
0.01
34,570,319
37,552
42,279
79,831
49,789
—
38,032
38,032
11,757
(20,575)
1,027
(7,791)
(592)
(7,199)
(0.21)
33,582,202
(0.21)
33,582,202
$
$
$
$
$
$
F-49
COLLEGIUM PHARMACEUTICAL, INC.
AMENDED AND RESTATED 2014 STOCK INCENTIVE PLAN
Restricted Stock Unit Grant Schedule
Exhibit 10.4(d)
Grantee’s name:
Grant Date:
[Name]
[Date]
Number of Restricted Stock Units granted:
[Quantity]
Vesting:
Subject to the Grantee’s continued service to
the Company through the applicable vesting dates, the Restricted
Stock Units shall vest in accordance with the schedule below.
Please refer to Appendix: Vesting Schedule.
If the Grantee’s service to the Company ceases for any reason, any Restricted Stock Units that are then still subject to
vesting conditions as of such date shall be immediately forfeited with no other compensation due to the Grantee.
Notwithstanding the foregoing, no Restricted Stock Units subject to this Agreement shall vest unless the Grantee has
complied with all applicable provisions of the Hart- Scott-Rodino Antitrust Improvements Act of 1976, as amended
(the “HSR Act”). If the Restricted Stock Units subject to this Agreement would have vested pursuant to this
Agreement but did not vest solely because the Grantee was not in compliance with all applicable provisions of the
HSR Act, the Vesting Date and the Share issuance date for such Restricted Stock Units shall occur on the first date
following the date on which such Restricted Stock Units would otherwise have vested pursuant to this Agreement on
which the Grantee has complied with all applicable provisions of the HSR Act.
COLLEGIUM PHARMACEUTICAL, INC.
By:
Name:
Title:
Date:
COLLEGIUM PHARMACEUTICAL, INC.
AMENDED AND RESTATED 2014 STOCK INCENTIVE PLAN
AWARD AGREEMENT FOR RESTRICTED STOCK UNITS
THIS AWARD AGREEMENT FOR RESTRICTED STOCK UNITS (this “Agreement”) is made by
Collegium Pharmaceutical, Inc. (the “Company”) to the participant named on the grant schedule attached hereto (the
“Grantee”), dated as of the date set forth on the grant schedule attached hereto (the “Grant Date”).
RECITALS
WHEREAS, the Company desires to award Restricted Stock Units to the Grantee under the Collegium
Pharmaceutical, Inc. Amended and Restated 2014 Stock Incentive Plan, as amended (the “Plan”), pursuant to the terms
of this Agreement.
NOW, THEREFORE, in consideration of these premises and the agreements set forth herein, the parties,
intending to be legally bound hereby, agree as follows:
1. Grant Schedule. Certain terms of the grant of Restricted Stock Units are set forth on the grant schedule (the
“Grant Schedule”) that is attached to, and is a part of, this Agreement.
2. Grant of Restricted Stock Units. As of the Grant Date, pursuant to the Plan, the Company hereby awards to
the Grantee the number of Restricted Stock Units set forth on the Grant Schedule (the “Award”), subject to
the restrictions and on the terms and conditions set forth in this Agreement and the Plan. The terms of the
Plan are hereby incorporated into this Agreement by this reference, as though fully set forth herein.
Capitalized terms used but not defined herein, including the Grant Schedule, will have the same meaning as
defined in the Plan.
3. Grant Date. The Grant Date of the Restricted Stock Units is set forth on the Grant Schedule.
4. Vesting. Subject to the further provisions of this Agreement, the Restricted Stock Units will vest as set forth
on the Grant Schedule (the date on which Restricted Stock Units vest being referred to as the “Vesting Date”).
5. Transferability. The Restricted Stock Units are not transferable or assignable otherwise than by will or by the
laws of descent and distribution. Any attempt to transfer Restricted Stock Units, whether by transfer, pledge,
hypothecation or otherwise and whether voluntary or involuntary, by operation of law or otherwise, will not
vest the transferee with any interest or right in or with respect to such Restricted Stock Units.
6.
Issuance of Shares.
a. Unless otherwise set forth on the Grant Schedule, within ten (10) business days following the
Vesting Date (including any accelerated vesting date provided in the Grant Schedule), the Company
shall issue to the Grantee, either by book-entry registration or issuance of a stock certificate or
certificates, a number of Shares equal to the number of Restricted Stock Units granted hereunder that
have vested as of such date. Any Shares issued to the Grantee hereunder shall be fully paid and non-
assessable.
b. The Grantee will not be deemed for any purpose to be, or have rights as, a stockholder of the
Company by virtue of the grant of Restricted Stock Units, until Shares are issued in settlement of
such Restricted Stock Units pursuant to Section 6(a) hereof. Upon the issuance of a stock certificate
or the making of an appropriate book entry on the books of the transfer agent, the Grantee will have
all of the rights of a stockholder.
7. Securities Matters. The Committee may from time to time impose any conditions on the Shares issuable with
respect to Restricted Stock Units as it deems necessary or advisable to ensure that the Plan satisfies the
COLLEGIUM PHARMACEUTICAL, INC.
AMENDED AND RESTATED 2014 STOCK INCENTIVE PLAN
conditions of Rule 16b-3, and that Shares are issued and resold in compliance with the Securities Act of 1933,
as amended.
8. Electronic Delivery of Documents. The Grantee hereby authorizes the Company to deliver electronically any
prospectuses or other documentation related to this Award, the Plan and any other compensation or benefit
plan or arrangement in effect from time to time (including, without limitation, reports, proxy statements or
other documents that are required to be delivered to participants in such plans or arrangements pursuant to
federal or state laws, rules or regulations). For this purpose, electronic delivery will include, without
limitation, delivery by means of e-mail or e-mail notification that such documentation is available on the
Company’s Intranet site. Upon written request, the Company will provide to the Grantee a paper copy of any
document also delivered to the Grantee electronically.
9. Delays or Omissions. No delay or omission to exercise any right, power or remedy accruing to any party
hereto upon any breach or default of any party under this Agreement, will impair any such right, power or
remedy of such party, nor will it be construed to be a waiver of any such breach or default, or an acquiescence
therein, or of or in any similar breach or default thereafter occurring, nor will any waiver of any single breach
or default be deemed a waiver of any other breach or default theretofore or thereafter occurring. Any waiver,
permit, consent or approval of any kind or character by the of any breach or default under this Agreement, or
any waiver on the part of any party or any provisions or conditions of this Agreement, must be in a writing
signed by such party and will be effective only to the extent specifically set forth in such writing.
10. Right of Discharge Preserved. The grant of Restricted Stock Units hereunder will not confer upon the Grantee
any right to continue in service with the Company or any of its subsidiaries or Affiliates.
11. The Plan. By accepting this Award, the Grantee acknowledges that the Grantee has received a copy of the
Plan, has read the Plan and is familiar with its terms, and accepts the Restricted Stock Units subject to all of
the terms and provisions of the Plan, as amended from time to time. Pursuant to the Plan, the Board or its
Committee is authorized to interpret the Plan and to adopt rules and regulations not inconsistent with the Plan
as it deems appropriate. By accepting this Award, the Grantee acknowledges and agrees to accept as
binding, conclusive and final all decisions or interpretations of the Board or its Committee upon any
questions arising under the Plan.
12. Governing Law. This Agreement and all claims or causes of action (whether in contract or tort) that may be
based upon, arise out of or relate to this Agreement or the negotiation, execution or performance of this
Agreement (including any claim or cause of action based upon, arising out of or related to any representation
or warranty made in or in connection with this Agreement or as an inducement to enter this Agreement) shall
be governed by, and enforced in accordance with, the laws of the Commonwealth of Virginia, without regard
to the application of the principles of conflicts of laws.
The Award is made by the Company as of the date stated in the introductory paragraph.
COLLEGIUM PHARMACEUTICAL, INC.
By:
Name:
Title:
Date:
COLLEGIUM PHARMACEUTICAL, INC.
AMENDED AND RESTATED 2014 STOCK INCENTIVE PLAN
Appendix: Vesting Schedule
Date
Quantity
Exhibit 10.14
EXECUTION VERSION
CONSENT AND FIRST AMENDMENT TO LOAN AGREEMENT
This Consent and First Amendment to Loan Agreement (this “Consent and Amendment”), dated
as of January 3, 2023 (the “Effective Date”), is entered into by and among COLLEGIUM
PHARMACEUTICAL, INC., a Virginia corporation (as “Borrower”), the Guarantors from time to time
party thereto, BIOPHARMA CREDIT PLC, a public limited company incorporated under the laws of
England and Wales (as the “Collateral Agent”), BPCR LIMITED PARTNERSHIP, a limited partnership
established under the laws of English and Wales (as a “Lender”) and BIOPHARMA CREDIT
INVESTMENTS V (MASTER) LP, a Cayman Islands exempted limited partnership acting by its general
partner, BioPharma Credit Investments V GP LLC (as a “Lender”).
RECITALS
WHEREAS, Borrower, Guarantors, the Collateral Agent and the Lenders have entered into that
certain Amended and Restated Loan Agreement dated as of March 22, 2022 (the “Loan Agreement”);
WHEREAS, the Borrower intends to launch a share buyback program of its Equity Interests in an
aggregate amount of $100,000,000 for the calendar year of 2023 (the “Repurchases”);
WHEREAS, the Repurchases are prohibited under Section 6.8 of the Loan Agreement;
WHEREAS, notwithstanding anything to the contrary set forth in the Loan Documents, including
the requirements set forth in Section 6.8 of the Loan Agreement, the Borrower has requested that the
Required Lenders and Collateral Agent consent, and the Required Lenders and Collateral Agent have
agreed to consent, to the treatment of the Repurchases as a Permitted Distribution permitted under Section
6.8 of the Loan Agreement (such consent, the “Specified Consent); and
WHEREAS, in accordance with Section 11.5 of the Loan Agreement, Borrower (acting for its own
behalf and on behalf of the other Credit Parties), Collateral Agent and the Lenders desire to amend the Loan
Agreement on the terms and conditions set forth herein.
AGREEMENT
NOW, THEREFORE, in consideration of the foregoing recitals and other good and valuable
consideration, the receipt and adequacy of which is hereby acknowledged, and intending to be legally
bound, the parties hereto agree as follows:
SECTION 1. Definitions; Interpretation. All capitalized terms used in this Consent &
Amendment (including in the recitals hereof) and not otherwise defined herein shall have the meanings
assigned to them in the Loan Agreement. The rules of interpretation set forth in the first paragraph of
Section 13.1 of the Loan Agreement shall be applicable to this Consent and Amendment and are
incorporated herein by this reference.
SECTION 2. Consent and Amendment to the Loan Agreement.
(a)
The Required Lenders and Collateral Agent hereby consent to the treatment of the
Repurchases as a Permitted Distribution.
(b)
The Loan Agreement shall be amended by deleting in its entirety Section 8.1(f) of the Loan
Agreement and replacing it as follows:
“ship, reclaim, recover, store, finish, maintain, repair, prepare for sale, advertise for sale, and sell
the Collateral. With respect to any and all Intellectual Property owned by any Credit Party and
included in Collateral, each Credit Party hereby grants to the Collateral Agent, for the benefit of
Lenders and the other Secured Parties, as of the Closing Date: (i) an irrevocable, non-exclusive,
assignable, royalty-free license or other right to use (and for its agents or representatives to use),
without charge, including the right to sublicense, use and practice, any and all such Intellectual
Property in order to take possession of, collect, receive, assemble, process, appropriate, remove,
realize upon, advertise for sale, sell, assign, license out, convey, transfer or grant options to
purchase any Collateral, and access to all media in which any of the licensed items may be recorded
or stored and to all Software and programs used for the compilation or printout thereof; and (ii) in
connection with the Collateral Agent’s exercise of its rights or remedies under this Section 8.1
(including in order to take possession of, collect, receive, assemble, process, appropriate, remove,
realize upon, sell, assign, license out, convey, transfer or grant options to purchase any Collateral),
each Credit Party’s rights under all licenses and all franchise Contracts inure to the benefit of all
Secured Parties;”
SECTION 3. Representations and Warranties; Reaffirmation.
(c)
Borrower hereby represents and warrants to each Lender and the Collateral Agent as
follows:
(i)
Borrower has all requisite power and authority to enter into this Consent and Amendment
and to carry out the transactions contemplated hereby.
(ii)
This Consent and Amendment has been duly executed and delivered by Borrower and is the
legally valid and binding obligation of such Person, enforceable against such Person in accordance with its
respective terms, except as such enforceability may be limited by bankruptcy, insolvency, reorganization,
moratorium or similar laws relating to or limiting creditors’ rights generally or by general principles of
equity.
(iii)
The execution, delivery and performance by Borrower of this Consent and Amendment
have been duly authorized and do not and will not: (A) conflict with any of such Person’s Operating
Documents, (B) contravene, conflict with, constitute a default under or violate any material Requirements of
Law, (C) contravene, conflict, result in any breach of, or require any payment to be made under any
provision of any security issued by such Person or of any agreement, instrument or other undertaking to
which such Person is a party or affecting such Person or the assets or properties of such Person or any of its
Subsidiaries, or violate any applicable order, writ, judgment, injunction, decree, determination or award of
any Governmental Authority by which Borrower or any of its Subsidiaries or any of its or their respective
properties or assets may be bound, (D) require any action by, filing, registration, or qualification with, or
Governmental Approval from, any Governmental Authority (except such Governmental Approvals which
have already been obtained and are in full force and effect), (E) constitute a material breach of or a material
default or an event of default (or the equivalent thereof, however described) under, or could be reasonably
be expected to give rise to the cancellation, termination or invalidation of or the acceleration of such
Person’s or any Subsidiary’s obligations under any Material Contract or (F) require any approval, consent,
exemption or authorization, or other action by, or notice to, or filing with, any Person other than a
Governmental Authority, including such Person’s stockholders, members or partners, (except such
approvals, consents, exemptions, authorizations, actions, notices and filings which have been or will be duly
obtained, taken, given or made on or before the Effective Date and are in full force and effect).
(iv)
Both before and immediately after giving effect to this Consent and Amendment, no Event
of Default or Default has occurred and is continuing.
(d)
Borrower hereby ratifies, confirms, reaffirms, and acknowledges its obligations under the
Loan Documents to which it is a party and agrees that the Loan Documents remain in full force and effect,
undiminished by this Consent and Amendment, except as expressly provided herein. By executing this
Consent and Amendment, Borrower acknowledges that it has read, consulted with its attorneys regarding,
and understands, this Consent and Amendment.
SECTION 4. References to and Effect on Loan Agreement. Except as specifically set forth
herein, this Consent and Amendment shall not modify or in any way or affect any of the terms, conditions,
covenants, representations and warranties contained in the Loan Agreement, or any of the rights of the
Lenders and the Collateral Agent therein, which shall remain in full force and effect and is hereby ratified
and confirmed in all respects. Except as specifically set forth herein, the execution, delivery and
effectiveness of this Consent and Amendment shall not directly or indirectly (i) constitute a consent or
waiver of any past, present or future breaches, violations or defaults of or under any provisions of the Loan
Agreement nor constitute a novation of any of the Obligations under the Loan Agreement, (ii) amend,
modify or operate as a waiver of any provision of the Loan Agreement or any right, power or remedy of any
Lender or the Collateral Agent, or (iii) constitute a course of dealing or other basis for altering the Loan
Agreement or any other Loan Document. Except as set forth herein, each of the Lenders and the Collateral
Agent reserves all of its rights, powers, and remedies under the Loan Documents and Requirements of Law.
Each of the Credit Parties acknowledges and agrees that the Specified Consent does not in any manner
whatsoever limit any right of any of the Lenders or the Collateral Agent to insist upon strict compliance by
Borrower with the Loan Agreement.
SECTION 5. Governing Law; Venue; Jury Trial Waiver. This Consent and Amendment shall be
construed in accordance with and governed by the law of the State of New York. The provisions of Section
10 (Choice of Law, Venue and Jury Trial Waiver) of the Loan Agreement shall apply hereto as if more fully
set forth herein as if references therein to “this Agreement” were references to this Consent and
Amendment.
SECTION 6. Counterparts. This Consent and Amendment may be executed in any number of
counterparts and by different parties on separate counterparts, each of which, when executed and delivered,
is an original, and all taken together, constitute one Consent and Amendment. Delivery of an executed
counterpart of a signature page of this Consent and Amendment by facsimile or other electronic imaging
means (e.g. “pdf” or “tif”) shall be effective as delivery of a manually executed counterpart of this Consent
and Amendment. The words “execution,” “signed,” “signature,” and words of like import in this Consent
and Amendment shall be deemed to include electronic signatures or electronic records, each of which shall
be of the same legal effect, validity or enforceability as a manually executed signature or the use of a paper-
based recordkeeping system, as the case may be, to the extent and as provided for under any applicable law,
including the Federal Electronic Signatures in Global and National Commerce Act, the New York State
Electronic Signatures and Records Act, or any other similar state laws based on the Uniform Electronic
Transactions Act.
[Remainder of Page Intentionally Left Blank]
IN WITNESS WHEREOF, each of the undersigned has caused this Consent and Amendment to
be duly executed and delivered as of the date first above written.
COLLEGIUM PHARMACEUTICAL INC.,
as Borrower
By:
Name:
Title:
/s/ Joseph Ciaffoni
Joseph Ciaffoni
President and Chief Executive Officer
COLLEGIUM SECURITIES CORPORATION,
as an additional Credit Party
By:
Name:
Title:
/s/ Joseph Ciaffoni
Joseph Ciaffoni
President
BIOPHARMA CREDIT PLC,
as Collateral Agent
By: Pharmakon Advisors, LP,
its Investment Manager
By: Pharmakon Management I, LLC,
its General Partner
By:
Name:
Title:
/s/ Pedro Gonzalez de Cosio
Pedro Gonzalez de Cosio
Managing Member
BPCR LIMITED PARTNERSHIP,
as a Lender
By: Pharmakon Advisors, LP,
its Investment Manager
By: Pharmakon Management I, LLC,
its General Partner
By:
Name:
Title:
/s/ Pedro Gonzalez de Cosio
Pedro Gonzalez de Cosio
Managing Member
BIOPHARMA CREDIT INVESTMENTS V (MASTER) LP,
as a Lender
By: Pharmakon Advisors, LP,
its Investment Manager
By: Pharmakon Management I, LLC,
its General Partner
By:
Name:
Title:
/s/ Pedro Gonzalez de Cosio
Pedro Gonzalez de Cosio
Managing Member
Exhibit 19
COLLEGIUM PHARMACEUTICAL, INC.
INSIDER TRADING POLICY
Effective February 8, 2023 (the “Effective Date”)
INTRODUCTION
This Insider Trading Policy (this “Policy”) has been adopted by the Board of Directors (the
“Board”) of Collegium Pharmaceutical, Inc. (the “Company”) and provides the standards of the
Company on trading of the Company’s securities or securities of other publicly traded companies
with whom the Company has a business relationship. This policy applies to all members of the
Board (each, a “director”), officers and employees of the Company and its subsidiaries.
One of the principal purposes of the federal and state securities laws is to prohibit so-called
“insider trading.” Simply stated, insider trading occurs when a person uses material, nonpublic
information obtained through involvement with a company to make decisions to purchase, sell, or
otherwise trade a company’s securities or to provide that information to others outside such
company. The prohibitions against insider trading apply to trades, tips and recommendations by
virtually any person, including all persons associated with the Company, if the information
involved is “material” and “nonpublic.” (These terms are defined in this Policy under Definitions
below.)
This Policy is designed to prevent insider trading or allegations of insider trading, and to
protect the Company’s and your reputation for integrity and ethical conduct.
You should read the Policy and ask any questions you may have of the Compliance
Officer identified below:
General Counsel Collegium Pharmaceutical, Inc.
100 Technology Center Drive, Suite 300
Stoughton, MA 02072
APPLICABILITY
This Policy applies to all transactions in (i) the Company’s securities, including common
stock, options and any other securities that the Company may issue, such as preferred stock, notes,
bonds and convertible securities, as well as to derivative securities relating to any of the
Company’s securities, whether or not issued by the Company and (ii) another company’s
securities, to the extent such securities are of publicly-traded companies with whom the Company
has a business relationship, including our vendors, customers, licensees and business partners.
This Policy’s trading restrictions generally do not apply to the exercise of a stock option for
cash or a true cashless exercise of a stock option. The trading restrictions do apply, however, to
any sale of the underlying stock or to a cashless exercise of the option through a broker, as this
entails selling a portion of the underlying stock to cover the costs of exercise.
This Policy applies to all directors, officers and employees of the Company and its
subsidiaries. The restrictions identified in this Policy also apply to your family members who
reside with you, anyone else who lives in your household and any family members who do not live
in your household but whose transactions in Company securities are directed by you or are subject
to your influence or control (such as parents or children who consult with you before they trade in
Company securities). You are responsible for making sure that the purchase or sale of any security
covered by this Policy by any such person complies with this Policy.
GENERAL POLICY
NO TRADING OR CAUSING TRADING WHILE IN POSSESSION OF MATERIAL,
NONPUBLIC INFORMATION
• No director, officer or employee may purchase or sell any Company security, directly or
through family members or other persons or entities, while in possession of material,
nonpublic information about the Company. (The terms “material” and “nonpublic” are
defined in Definitions – Materiality and – Nonpublic Information below.)
• No director, officer or employee who knows of any material, nonpublic information about
the Company may communicate that information or recommend the purchase or sale of the
Company’s securities to any other person, including family and friends, which is an illegal
practice known as “tipping.”
• No director, officer or employee may purchase or sell any security of any other public
company with whom the Company has a business relationship, whether or not issued by
such other company, while in possession of material nonpublic information about that
company that was obtained in the course of his or her involvement with the Company. No
director, officer or employee who knows of any such material nonpublic information may
communicate that information to any other person, including family and friends.
• All Covered Individuals (as defined in Annex A) must “pre-clear” all trading in securities
of the Company in accordance with the procedures set forth in Pre-Clearance of Securities
Transactions below. Annex A hereto sets forth the list of Covered Individuals as of the date
indicated thereon. The Compliance Officer shall update Annex A from time to time as
necessary to ensure that it remains current.
Other Prohibited Transactions
Particular types of hedging or monetization transactions allow a person to lock in much of
the value of his or her stock holdings, often in exchange for all or part of the potential for upside
appreciation in the stock. These transactions allow the person to continue to own the
covered securities, but without the full risks and rewards of ownership. When that occurs, the
person may no longer have the same objectives as the Company’s other shareholders. Accordingly,
all trading in the Company’s securities by directors, officers or employees, including such person’s
immediate family and the other members of their household, is subject to the following:
•
Short sales. Directors, officers or employees may not sell the Company’s securities short
(sales of securities that are not then owned), including a “sale against the box” (a sale with
delayed delivery);
• Options trading. Directors, officers or employees may not buy or sell puts or calls or other
derivative securities on the Company’s securities;
• Margin accounts and pledging. Directors, officers or employees may not hold Company
securities in a margin account or pledge Company securities as collateral for a loan; and
• Hedging. Directors, officers or employees may not enter into hedging or monetization
transactions or similar arrangements with respect to Company securities, including zero-
cost collars, prepaid variable forward sale contracts, equity swaps and exchange funds.
BLACKOUT PERIODS
Quarterly Blackout Periods
A quarterly blackout period will begin at the close of business on the date that is two weeks
before the end of each fiscal quarter and end at the close of business on the first full trading day
following the date of the Company’s earnings release with respect to such fiscal quarter in the
ordinary course (each such period, a “Quarterly Blackout Period”).
All Blackout Restricted Persons (as defined in Annex B) are prohibited from trading in the
Company’s securities; adopting, amending or modifying a 10b5-1 plan to trade in the Company’s
securities; transferring any Company securities by gift (including charitable donations); or
exercising any right to purchase Company securities other than by paying the exercise price
therefore in cash during a Quarterly Blackout Period, subject to the limitations and exceptions
described below (“Blackout Restricted Activities”). Annex B hereto sets forth the list of Blackout
Restricted Person as of the date indicated thereon. The Compliance Officer shall update Annex B
from time to time as necessary to ensure that it remains current.
Interim Earnings Guidance
The Company may on occasion issue interim earnings guidance or other potentially
material financial information by means of a press release, SEC filing on Form 8-K or other means
designed to achieve widespread dissemination of the information. All Blackout Restricted Persons
should anticipate that trading will be prohibited while the Company is in the process of assembling
the information to be released and until the close of business on the first full trading day following
the date of the Company’s release of such information.
Other Blackout Periods
From time to time, an event may occur that is material to the Company and is known to
only a few directors and executives (such as negotiation of mergers, acquisitions or dispositions or
new product developments). So long as the event remains material and nonpublic, the persons who
are aware of the event may not engage in Blackout Restricted Activities. The existence of an
event-specific blackout will not be announced, other than to those who are aware of the event
giving rise to the blackout. If, however, a person who (i) is subject to this Policy and (ii) is aware
of the event giving rise to the blackout, requests permission to trade in the Company’s securities
during an event-specific blackout, the Compliance Officer will not grant such pre-clearance.
Hardship Exception
A Blackout Restricted Person who has an unexpected and urgent need to sell Company
stock in order to generate cash may, in appropriate circumstances, be permitted to sell Company
stock, even during the Quarterly Blackout Period. Hardship exceptions are expected to be
requested only rarely, and may be granted only by the Compliance Officer and must be requested
at least two days in advance of the proposed trade. A hardship exception may be granted only if the
Compliance Officer reasonably concludes that the individual making the hardship exception
request does not possess material, nonpublic information.
Exceptions for Approved 10b5-1 Plans
These trading restrictions do not apply to transactions under a pre-existing written plan,
contract, instruction or arrangement pursuant to Rule 10b5-1 under the Securities Exchange Act of
1934, as amended (an “Approved 10b5-1 Plan”) that complies with the conditions set forth below:
1. Approval. All persons subject to this Policy must obtain the written approval of the
Compliance Officer prior to (i) adopting any new plan or (ii) modifying, amending or
terminating any existing plan. The Compliance Officer shall review and ensure each proposed
plan (or modification, amendment or termination of an existing plan) submitted to the
Compliance Officer complies with the provisions of this Policy and applicable law, as then in
effect, prior to granting any such approval (which approval shall be evidenced by such
Compliance Officer’s signature on the approved plan (or modification, amendment, or
termination of an existing plan).
2. Mandatory Cooling-Off Periods.
• Directors and Executive Officers. New plans submitted by a director or an executive
officer (as such term is defined in Section 16 of the Securities Act of 1934, as amended,
and the rules promulgated thereunder) of the Company, and amendments or modifications
to an existing plan, must provide for transactions to occur (i) no earlier than the later of the
date (the “Trade Commencement Date”) that is (x) ninety (90) days after the effective date
of the new plan, or amendment or modification to an existing plan, and (y) two
business days following the disclosure by the Company of its financial results in a Form
10-Q or Form 10-K for the fiscal quarter in which the plan was adopted, amended or
modified, provided that the mandatory cooling-off period shall not exceed one hundred
twenty (120) days after adoption of the new plan, or amendment or modification to an
existing plan, and (ii) no later than one (1) year after the Trade Commencement Date;
• All Other Persons. New plans submitted by any person subject to this Policy, other than
directors and executive officers of the Company, and amendments or modifications to an
existing plan by such persons, must provide for transactions to occur (i) no earlier than
thirty (30) days after the effective date of the new plan, or amendment or modification to an
existing plan, and (ii) no later than one (1) year after the effective date thereof (or, in the
case of an amendment, no later than one (1) year after the effective date of such
amendment).
3. Good Faith Certification. All new plans, and any amendments or modifications of an
existing plan, must be entered into in good faith by the trading person at a time when the
trading person was not in possession of material nonpublic information about the Company.
All directors and executive officers seeking to establish a new plan or amend or modify an
existing plan will be required to provide a written representation to the Company certifying
that (i) they are not aware of material nonpublic information about the Company or its
securities, and (ii) they are adopting the new plan, or modifying or amending an existing plan,
in good faith and not as part of a plan or scheme to evade the prohibitions of this Policy or
Rule 10b-5-1.
4. Discretionary Authority. All new plans, and any modifications or amendments to an existing
plan, must give a third party the discretionary authority to execute purchases and sales under
the plan, on behalf of but outside the control of the trading person, provided the third party
does not possess any material nonpublic information about the Company. Alternatively, the
plan must explicitly specify the security or securities to be purchased or sold, the number of
shares, the prices and/or dates of transactions, or other formula(s) describing such transactions.
5. Overlapping Plans. No person subject to this Policy may maintain more than one active plan
at the same time, without the pre-approval of the Compliance Officer. Multiple overlapping
plans may be approved by the Compliance Officer in limited circumstances as permitted under
Rule 10b5-1.
• A person subject to this Policy may maintain two separate Rule 10b5-1 plans if trading
under the later-commencing plan is not authorized to begin until after all trades under the
earlier-commencing plan are completed or expire without execution; provided, however,
that any early termination of the earlier-commencing plan will trigger a new cooling off
period (as set forth in paragraph 2 above) before trades may begin under the later-
commencing plan.
• This restriction on multiple overlapping plans will not apply to a plan adopted solely and
exclusively for the purpose of selling securities to satisfy a person’s tax obligations
through a “sell-to-cover” method in connection with the vesting of equity awards (“Sell-to-
Cover Plans”). Sales under Sell-to-Cover Plans must be strictly limited to the number of
securities needed to cover such person’s tax obligations and the award holder may not be
permitted to exercise control over the timing of such sales. This exemption does not apply
to plans for sales incident to the exercise of option awards.
•
Separate contracts with different broker-dealers to execute trades pursuant to a single Rule
10b5-1 trading plan may be treated as a single plan, in which case a modification,
amendment or termination to any of the individual plans will be considered a modification,
amendment or termination of all of the plans.
6. Single-Trade Plans. Only one “single-trade plan” may be utilized by a person subject to this
policy in any twelve-month period. A single-trade plan is a Rule 10b5-1 trading plan for the
open market purchase or sale of the total amount of the securities subject to the plan as a single
transaction. This restriction does not apply to Sell-to-Cover Plans.
PRE-CLEARANCE OF SECURITIES TRANSACTIONS
Because Covered Individuals may be likely to obtain material nonpublic information on a
regular basis, the Company requires that all Covered Individuals refrain from trading, even when
no blackout period is in effect, without first pre-clearing all transactions in the Company’s
securities.
Except for purchases and sales pursuant to an Approved 10b5-1 Plan, no Covered
Individual may, directly or indirectly, purchase or sell (or otherwise make any transfer or gift
(including any charitable donation)) any Company security at any time without first obtaining prior
approval from the Compliance Officer. These procedures also apply to transactions by such
person’s immediate family members and other members of their household, and to transactions by
entities over which such person exercises control. In advance of pre-clearance of a transaction in
the Company’s securities, Covered Individuals must confirm that they are not in possession of
material nonpublic information.
A request for pre-clearance should be submitted to the Compliance Officer at least one
business day in advance of the proposed transaction. The Compliance Officer shall record the date
each request is received and the date and time each request is approved or disapproved. Unless
revoked, a grant of permission will normally remain valid until the close of trading two business
days after the day on which it was granted. If the transaction does not occur during the two
business day period, pre-clearance of the transaction must be re-requested. For example, if the pre-
clearance request was approved on Monday, June 3, 2019, then the Covered Individual must
complete his or her transaction on or prior to the close of business on Wednesday, June 5, 2019.
If you seek pre-clearance for a transaction and if permission to engage in the transaction is
denied, you should refrain from initiating any transaction in the Company’s securities and
should not inform any other person of this denial as such denial could constitute, or signal the
existence of, material nonpublic information.
POST-EMPLOYMENT TRANSACTIONS
The trading restrictions of this Policy will continue to apply to all directors, officers and
employees of the Company who are aware of material, nonpublic information after they terminate
employment or services. Such persons may not trade in the Company’s securities until that
information has become public or is no longer material. In all other respects, the pre-clearance and
blackout procedures set forth in this Policy will cease to apply to such person’s transactions in the
Company’s securities upon the expiration of any “blackout period” that is applicable at the time of
such person’s termination of employment or services.
COMPLIANCE WITH SECTION 16 AND RULE 144
Directors and executive officers are responsible for compliance with Section 16 of the
Securities Exchange Act and Rule 144 of the Securities Act in connection with their transactions in
the Company’s securities. The requirements of this Policy do not supersede the required
compliance with your obligations under Section 16 or Rule 144.
Section 16
Directors and executive officers should be aware that most transactions in the Company
stock are subject to the accelerated two business day reporting requirements under Section 16. The
Company’s policy is to assist directors and officers in completing and filing their Section 16
reports. It is important that the Compliance Officer receive prompt notice of reportable
transactions, so that the Company can assist in filing the required reports on a timely basis. With
respect to any purchase or sale under an Approved 10b5-1 Plan, the third party effecting
transactions on behalf of the trading person who is subject to Section 16 should be instructed to
send duplicate confirmations of all such transactions to the Compliance Officer on the trade date in
order to facilitate timely Section 16 reporting.
Rule 144
Directors and executive officers are required to file Form 144 before making open market
sales of Company stock. This requirement applies whether the shares are legended or unlegended,
restricted or unrestricted, held in a brokerage account, represented by a stock certificate or book
entry position. Form 144 is generally prepared and filed by such individual’s broker.
“Materiality”
DEFINITIONS
Insider trading restrictions come into play only if the information you possess is “material.”
Information is generally regarded as “material” if it has market significance, that is, if
its public dissemination is likely to affect the market price of securities, or if it otherwise is
information that a reasonable investor would want to know before making an investment decision.
Information dealing with the following subjects is reasonably likely to be found material in
particular situations:
significant write-downs in assets or increases in reserves;
developments regarding significant litigation or government agency investigations;
liquidity problems;
projections of future earnings or losses or other earnings guidance;
changes in earnings estimates or unusual gains or losses in major operations;
changes in the Company’s pricing or cost structure;
•
•
•
•
•
•
• major marketing changes;
• major changes in management;
•
• major developments in, or results of, clinical trials of the Company’s products;
•
developments regarding regulatory approval or disapproval of the Company’s products;
a significant cybersecurity incident, such as a computer system failure, accident or security
breach, that could result in a material disruption of the company’s operations, including its
commercialization and drug development programs;
• major events regarding the Company’s securities, including the declaration of a stock split,
•
•
•
a change in dividend policy or the offering of additional securities;
extraordinary borrowings or similar financing transactions;
changes in debt ratings; and
public offerings or proposals, plans or agreements, even if preliminary in nature, involving
mergers, acquisitions, divestitures, recapitalizations, strategic alliances, licensing
arrangements, joint ventures, or purchases or sales of substantial assets.
Material information is not limited to historical facts but may also include projections and
forecasts. With respect to a future event, such as a merger, acquisition or introduction of a new
solution, the point at which negotiations or product development are determined to be material is
determined by balancing the probability that the event will occur against the magnitude of the
effect the event would have on a company’s operations or stock price should it occur. Thus,
information concerning an event that would have a large effect on stock price, such as a merger,
may be material even if the probability that the event will occur is not great. Because trading that
receives scrutiny will be evaluated after the fact with the benefit of hindsight, questions concerning
the materiality of particular information should be resolved in favor of materiality, and trading
should be avoided. If you are unsure whether information is material, you should consult the
Compliance Officer before making any decision to disclose such information or to trade in or
recommend securities to which that information relates.
“Nonpublic Information”
Insider trading prohibitions come into play only when a person possesses information that
is material and “nonpublic.” To be “public” the information must have been disseminated in a
manner designed to reach investors generally (such as by a press release or an SEC filing), and the
investors must be given the opportunity to absorb the information fully. Nonpublic information
may include:
•
•
•
information available to a select group of analysts or brokers or institutional investors;
undisclosed facts that are the subject of rumors, even if the rumors are widely circulated;
and
information that has been entrusted to the Company on a confidential basis until a public
announcement of the information has been made and enough time has elapsed for the
market to respond to a public announcement of the information.
As a general rule, information should be considered nonpublic until the conclusion of one full
trading day after the day on which the information is released. For example, if the Company makes
an announcement after the market opens on a Monday, the first time you can buy or sell Company
securities is on Wednesday (assuming you are not aware of other material, nonpublic information
at that time). As with questions of materiality, if you are not sure whether information is
considered public, you should either consult with the Compliance Officer or assume that the
information is “nonpublic” and treat it as confidential.
“Compliance Officer”
The Board of Directors has appointed the General Counsel, or in his or her absence, the
General Counsel’s designee, as the compliance officer (the “Compliance Officer”) for this Policy.
CERTIFICATION
All employees of the Company must certify their understanding of, and intent to comply
with, this Policy, on the applicable form attached to this Policy.
VIOLATIONS OF INSIDER TRADING LAWS
Penalties for trading on or communicating material nonpublic information can be severe,
both for individuals involved in such unlawful conduct and their employers and supervisors, and
may include jail terms, criminal fines, civil penalties and civil enforcement injunctions. Given the
severity of the potential penalties, compliance with this Policy is absolutely mandatory.
Legal Penalties
Violation of this Policy may result in both civil and criminal penalties under applicable
securities laws including imprisonment, criminal fines and civil penalties. In addition, a person
who tips others may also be liable for transactions by the tippees to whom he or she has disclosed
material nonpublic information. Tippers can be subject to the same penalties and sanctions as the
tippees, and the Securities and Exchange Commission has imposed large penalties even when the
tipper did not profit from the transaction.
Company-imposed Penalties
Employees who violate this Policy may be subject to disciplinary action by the Company,
including dismissal for cause. Any exceptions to the Policy, if permitted, may only be granted by
the Compliance Officer and must be provided before any activity contrary to the above
requirements takes place.
To Collegium Pharmaceutical, Inc.:
CERTIFICATION
I have received and read a copy of the Collegium Pharmaceutical, Inc. Insider Trading Policy. I
understand and acknowledge that I am subject to the Insider Trading Policy and I hereby agree to
comply with the requirements of this Policy, including the portion thereof relating to Pre-clearance
and Blackout Procedures.
(Name)
(Signature)
(Date)
This document states a policy of Collegium Pharmaceutical, Inc. and is not intended to be
regarded as the rendering of legal advice.
ANNEX A
Covered Individuals
As of the Effective Date, the “Covered Individuals” are:
• All directors of the Company;
• All Section 16 executive officers of the Company;
• All members of the executive committee of the Company;
• The vice president of investor relations, vice president of finance, vice president of
commercial finance, vice president of commercial operations, senior director of financial
operations, controller and each other employee involved in, or with direct access to, the
financial close process;
• Each employee involved in business development or market access initiatives; and
• Each other employee that the Compliance Officer may, from time to time, designate in his
or her discretion.
ANNEX B
Blackout Restricted Persons
As of the Effective Date, the “Blackout Restricted Persons” are:
• All directors of the Company;
• All Section 16 executive officers of the Company;
• All members of the executive committee of the Company;
• The vice president of investor relations, vice president of finance, vice president of
commercial finance, vice president of commercial operations, senior director of financial
operations, controller and each other employee involved in, or with direct access to, the
financial close process; and
• The vice president of commercial finance, vice president of commercial operations, senior
director of finance, controller and each other employee involved in, or with direct access to,
the financial close process.
Exhibit 21.1
Subsidiaries of Collegium Pharmaceutical, Inc.
Subsidiary
Jurisdiction of Incorporation
Collegium Securities Corporation
Massachusetts
Collegium NF, LLC
BioDelivery Sciences International, Inc.
Arius Pharmaceuticals, Inc.
Arius Two, Inc.
Delaware
Delaware
Delaware
Delaware
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We consent to the incorporation by reference in Registration Statement No. 333-237200 on Form S-3 and Registration
Statement Nos. 333-207744, 333-218767, 333-225498, 333-233092, 333-245649, 333-258752, 333-266778, and 333-
273874 on Form S-8 of our reports dated February 22, 2024, relating to the financial statements of Collegium
Pharmaceutical, Inc. (the “Company”), and the effectiveness of the Company's internal control over financial reporting
appearing in this Annual Report on Form 10-K of Collegium Pharmaceutical, Inc. for the year ended December 31,
2023.
Exhibit 23.1
/s/ Deloitte & Touche LLP
Boston, Massachusetts
February 22, 2024
Exhibit 31.1
CERTIFICATION OF CHIEF EXECUTIVE OFFICER PURSUANT
TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Joseph Ciaffoni, certify that:
1. I have reviewed this annual report on Form 10-K of Collegium Pharmaceutical, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material
fact necessary to make the statements made, in light of the circumstances under which such statements were made, not
misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present
in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the
periods presented in this report;
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and
procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as
defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a)
(b)
(c)
(d)
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to
be designed under our supervision, to ensure that material information relating to the registrant, including
its consolidated subsidiaries, is made known to us by others within those entities, particularly during the
period in which this report is being prepared;
Designed such internal control over financial reporting, or caused such internal control over financial
reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability
of financial reporting and the preparation of financial statements for external purposes in accordance with
generally accepted accounting principles;
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this
report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of
the period covered by this report based on such evaluation; and
Disclosed in this report any change in the registrant’s internal control over financial reporting that
occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case
of an annual report) that has materially affected, or is reasonably likely to materially affect, the
registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over
financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons
performing the equivalent functions):
(a)
(b)
All significant deficiencies and material weaknesses in the design or operation of internal control over
financial reporting which are reasonably likely to adversely affect the registrant’s ability to record,
process, summarize and report financial information; and
Any fraud, whether or not material, that involves management or other employees who have a significant
role in the registrant’s internal control over financial reporting.
/s/ JOSEPH CIAFFONI
Joseph Ciaffoni
President and Chief Executive Officer
Dated: February 22, 2024
Exhibit 31.2
CERTIFICATION OF CHIEF FINANCIAL OFFICER PURSUANT
TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Colleen Tupper, certify that:
1. I have reviewed this annual report on Form 10-K of Collegium Pharmaceutical, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material
fact necessary to make the statements made, in light of the circumstances under which such statements were made, not
misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present
in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the
periods presented in this report;
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and
procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as
defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a)
(b)
(c)
(d)
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to
be designed under our supervision, to ensure that material information relating to the registrant, including
its consolidated subsidiaries, is made known to us by others within those entities, particularly during the
period in which this report is being prepared;
Designed such internal control over financial reporting, or caused such internal control over financial
reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability
of financial reporting and the preparation of financial statements for external purposes in accordance with
generally accepted accounting principles;
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this
report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of
the period covered by this report based on such evaluation; and
Disclosed in this report any change in the registrant’s internal control over financial reporting that
occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case
of an annual report) that has materially affected, or is reasonably likely to materially affect, the
registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over
financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons
performing the equivalent functions):
(a)
(b)
All significant deficiencies and material weaknesses in the design or operation of internal control over
financial reporting which are reasonably likely to adversely affect the registrant’s ability to record,
process, summarize and report financial information; and
Any fraud, whether or not material, that involves management or other employees who have a significant
role in the registrant’s internal control over financial reporting.
/s/ COLLEEN TUPPER
Colleen Tupper
Executive Vice President and Chief Financial Officer
Dated: February 22, 2024
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
Exhibit 32.1
In connection with the annual report on Form 10-K of Collegium Pharmaceutical, Inc. (the “Company”) for the fiscal year
ended December 31, 2023 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), the
undersigned, Joseph Ciaffoni, President and Chief Executive Officer of the Company, hereby certifies, pursuant to 18
U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to their knowledge:
(1)
(2)
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange
Act of 1934; and
The information contained in the Report fairly presents, in all material respects, the financial condition
and results of operations of the Company.
Date: February 22, 2024
/s/ JOSEPH CIAFFONI
Joseph Ciaffoni
President and Chief Executive Officer
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
Exhibit 32.2
In connection with the annual report on Form 10-K of Collegium Pharmaceutical, Inc. (the “Company”) for the fiscal year
ended December 31, 2023 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), the
undersigned, Colleen Tupper, Executive Vice President and Chief Financial Officer of the Company, hereby certifies,
pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to their
knowledge:
(1)
(2)
The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act
of 1934; and
The information contained in the Report fairly presents, in all material respects, the financial condition
and results of operations of the Company.
/s/ COLLEEN TUPPER
Colleen Tupper
Executive Vice President and Chief Financial Officer
Date: February 22, 2024
Exhibit 97
COLLEGIUM PHARMACEUTICAL, INC.
CLAWBACK POLICY
Effective February 6, 2020
Amended Effective September 22, 2023 (the “Amended Effective Date”)
I.
PURPOSE
The Board of Directors (the “Board”) of Collegium Pharmaceutical, Inc. (the “Company”) believes
that it is in the best interest of the Company and its shareholders to create and maintain a culture that
emphasizes integrity and accountability and that reinforces the Company’s compensation philosophy. The
Board has adopted this clawback policy (as amended, the “Clawback Policy”) which provides for
recoupment of certain executive compensation in the event of a Financial Restatement (as defined below)
in accordance with rules issued by the United States Securities and Exchange Commission (the “SEC”)
under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and the Nasdaq Stock
Market LLC (the “Exchange”). Capitalized terms used and not otherwise defined herein shall have the
meanings given in Article IV below.
II.
COVERED PERSONS
A “Covered Individual” under this Clawback Policy means (i) each individual who served as an
Executive Officer at any time during the performance period applicable to the Incentive Compensation,
whether or not still employed by the Company (and regardless of whether such Incentive Compensation
was received during or after such person’s service as an Executive Officer) and (ii) such other current or
former employees of the Company who may from time to time be deemed subject to this Clawback Policy
by the Compensation Committee of the Board (the “Committee”).
III.
RECOVERY
If the Company is required to prepare a Financial Restatement, the Company shall recover
reasonably promptly all Erroneously Awarded Compensation from Covered Individuals with respect to
such Financial Restatement.
The method of recovery of Erroneously Awarded Compensation will be determined by the
Committee and may include (without limitation): (a) recoupment of cash or shares of Company stock;
(b) forfeiture of unvested awards; (c) cancellation of outstanding vested awards; (d) offset of other amounts
owed to the Covered Individual; (e) reduction of future compensation; and (f) any other remedial or
recovery action permitted by law.
If the Erroneously Awarded Compensation includes shares of Company stock (or derivatives
thereof), the Committee may seek to require that the Covered Individual repay to the Company any
dividends or dividend equivalents paid with respect to those securities, and any profits realized, directly or
indirectly, from the sale or other disposition of those securities.
Notwithstanding anything to the contrary set forth in any agreement with, or the organizational
documents of, the Company or any of its subsidiaries, Covered Individuals are not entitled to
indemnification for any Erroneously Awarded Compensation or for any losses arising out of or in any way
related to Erroneously Awarded Compensation recovered under this Clawback Policy.
This Clawback Policy shall be binding and enforceable against all Covered Individuals and their
respective beneficiaries, heirs, executors, administrators or other legal representatives.
The Company may elect not to recover Erroneously Awarded Compensation pursuant to this
Clawback Policy if the Committee determines that recovery would be impracticable, and one or more of
the following conditions, together with any further requirements set forth in the Applicable Rules, are
met: (i) the direct expense paid to a third party, including outside legal counsel, to assist in enforcing this
Policy would exceed the amount to be recovered, and the Company has made a reasonable attempt to
recover such Erroneously Awarded Compensation; or (ii) recovery would likely cause an otherwise tax-
qualified retirement plan to fail to be so qualified under applicable regulations.
IV.
ADDITIONAL DEFINITIONS
1.
2.
3.
4.
“Applicable Period” means the three completed fiscal years immediately preceding the
Restatement Date for a Financial Restatement. The Applicable Period will include any
transition period resulting from a change in the Company’s fiscal year, if that transition
period occurs within or immediately following those three completed years; provided that
a transition period of nine to 12 months will be deemed a completed fiscal year.
“Applicable Rules” means any rules or regulations adopted by the Exchange pursuant to
Rule 10D-1 under the Exchange Act and any applicable rules or regulations adopted by the
SEC pursuant to Section 10D of the Exchange Act.
“Erroneously Awarded Compensation” means, with respect to any Covered Individual, the
excess of (i) the Covered Individual’s actual Incentive Compensation over (ii) the Incentive
Compensation the Covered Individual otherwise would have earned, became vested in or
been granted during the Applicable Period if the Company’s financial statements had
reflected the restated amounts in a Financial Restatement. Erroneously Awarded
Compensation will be computed without regard to taxes paid. Erroneously Awarded
Compensation shall not include any Incentive Compensation received by a Covered
Individual prior to a Covered Individual’s service as an Executive Officer. Calculation of
Erroneously Awarded Compensation with respect to Incentive Compensation based on
stock price or total shareholder return, where the amount of Erroneously Awarded
Compensation is not subject to mathematical recalculation directly from the information in
a Financial Restatement, shall be based on a reasonable estimate of the effect of the
Financial Restatement on the stock price or total shareholder return upon which the
Incentive Compensation was received, and the Company shall maintain documentation of
the determination of such reasonable estimate and provide such documentation to the
Exchange in accordance with the Applicable Rules. Incentive Compensation is deemed
received, earned or vested when the Financial Reporting Measure is attained, not when the
actual payment, grant or vesting occurs. Incentive Compensation received by a Covered
Individual prior to the Amended Effective Date shall be subject to the terms of this
Clawback Policy as in effect prior to the Amended Effective Date.
“Executive Officer” means any person who served the Company in any of the following
roles: the president, principal financial officer, principal accounting officer (or if there is
no such accounting officer the controller), any vice president in charge of a principal
business unit, division or function (such as sales, administration or finance), any other
officer who performs a policy making function or any other person who performs similar
policy making functions for the Company. Executive officers of parents or subsidiaries
5.
6.
7.
8.
of the Company may be deemed executive officers of the Company if they perform such
policy making functions for the Company.
“Financial Reporting Measures” mean measures that are determined and presented in
accordance with the accounting principles used in preparing the Company’s financial
statements, any measures that are derived wholly or in part from such measures (including,
for example, a non-GAAP financial measure), and stock price and total shareholder return.
“Financial Restatement” means a restatement of previously issued financial statements of
the Company due to the material noncompliance of the Company with any financial
reporting requirement under the securities laws, including any required restatement to
correct an error in previously-issued financial statements that is material to the previously-
issued financial statements or that would result in a material misstatement if the error were
corrected in the current period or left uncorrected in the current period
“Incentive Compensation” means any compensation that is granted, earned or vested based
wholly or in part upon the attainment, during the Applicable Period, of any Financial
Reporting Measure.
“Restatement Date” means, with respect to a Financial Restatement, the earlier to occur of:
(i) the date the Board concludes, or reasonably should have concluded, that the Company
is required to prepare the Financial Restatement or (ii) the date a court, regulator or other
legally authorized body directs the Company to prepare the Financial Restatement.
V.
TAX CONSIDERATIONS
To the extent that, pursuant to this Clawback Policy, the Company is entitled to recover any
Erroneously Awarded Compensation that is received by a Covered Individual, the gross amount received
(i.e., the amount the Covered Individual received, or was entitled to receive, before any deductions for tax
withholding or other payments) shall be returned by the Covered Individual.
VI.
ADMINISTRATION
The Committee has the exclusive power and authority to administer this Clawback Policy,
including, without limitation, the right and power to interpret this Clawback Policy and to make all
determinations deemed necessary or advisable for the administration of this Clawback Policy; provided,
however, that the Board shall have exclusive authority to authorize the Company to prepare a Financial
Restatement. In doing so, the Board may rely on a recommendation of the Audit Committee of the Board.
All actions, interpretations and determinations taken or made by the Committee will be final, conclusive
and binding, and any such actions, interpretations and determinations need not be uniform with respect to
all Covered Individuals. The Company’s right of recoupment under this Clawback Policy is in addition to
any right or remedy otherwise available to the Company, including (without limitation) disciplinary action
up to and including termination of employment and the initiation of civil or criminal proceedings; provided
that there shall be no duplication of recovery under this Clawback Policy and Section 304 of the Sarbanes-
Oxley Act of 2002.
This Clawback Policy shall be interpreted in a manner that is consistent with the Applicable
Rules and any other applicable law. The Committee shall take into consideration any applicable
interpretations and guidance of the SEC in interpreting this Clawback Policy, including, for example, in
determining whether a financial restatement qualifies as a Financial Restatement hereunder. To the
extent the Applicable Rules require recovery of Incentive Compensation in additional circumstances
besides those specified above, nothing in this Clawback Policy shall be deemed to limit or restrict the
right or obligation of the Company to recover Incentive Compensation to the fullest extent required by
the Applicable Rules.