COLLEGIUM PHARMACEUTICAL INC
For the period ended Dec 31, 2024. Filed Feb 27, 2025.
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A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2024 · Filed Feb 27, 2025
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM****10-K
| For the year ended December 31, 2024 | |
|---|---|
| | |
| 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 DriveStoughton, 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 | Trading Symbol(s) | Name of exchange on which registered: |
|---|---|---|
| Common stock, par value $0.001 per share | COLL | 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.
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| Large accelerated filer ☒ | Accelerated filer ◻ | Non-accelerated filer ◻(Do not check ifsmaller 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 28, 2024, 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 $1,032.8 million, based on the closing price of the registrant’s common stock on The NASDAQ Global Select Market on June 28, 2024 of $32.20 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, 2025, there were 31,485,523 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 2025 Annual Meeting of Shareholders (the "Proxy Statement"), to be filed within 120 days of the registrant's year ended December 31, 2024, 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
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| · Page No. | |||||
| | PART I | | | | |
| | Item 1. | Business | | 3 | |
| | Item 1A. | Risk Factors | | 23 | |
| | Item 1B. | Unresolved Staff Comments | | 41 | |
| | Item 1C. | Cybersecurity | | 41 | |
| | Item 2. | Properties | | 42 | |
| | Item 3. | Legal Proceedings | | 43 | |
| | Item 4. | Mine Safety Disclosures | | 43 | |
| | PART II | | | | |
| | Item 5. | Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities | | 43 | |
| | Item 6. | [Reserved] | | 45 | |
| | Item 7. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | | 46 | |
| | Item 7A. | Quantitative and Qualitative Disclosures about Market Risk | | 59 | |
| | Item 8. | Consolidated Financial Statements and Supplementary Data | | 60 | |
| | Item 9. | Changes in and Disagreements with Accountants on Accounting and Financial Disclosure | | 60 | |
| | Item 9A. | Controls and Procedures | | 60 | |
| | Item 9B. | Other Information | | 63 | |
| | Item 9C. | Disclosure Regarding Foreign Jurisdictions that Prevent Inspections | | 63 | |
| | PART III | | | | |
| | Item 10. | Directors, Executive Officers and Corporate Governance | | 63 | |
| | Item 11. | Executive Compensation | | 63 | |
| | Item 12. | Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | | 64 | |
| | Item 13. | Certain Relationships and Related Transactions, and Director Independence | | 64 | |
| | Item 14. | Principal Accountant Fees and Services | | 64 | |
| | PART IV | | | | |
| | Item 15. | Exhibits and Financial Statement Schedules | | 64 | |
| | SIGNATURES | | | 68 | |
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 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.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.