UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): February 27, 2025
COLLEGIUM PHARMACEUTICAL, INC.
(Exact name of registrant as specified in its charter)
Virginia | 001-37372 | 03-0416362 |
(State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification No.) |
100 Technology Center Drive | ||
Suite 300 | ||
Stoughton, MA 02072 | ||
(Address of principal executive offices) (Zip Code) |
Registrant’s telephone number, including area code: (781) 713-3699
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
Common stock, par value $0.001 per share | COLL | The NASDAQ Global Select Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
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. ☐
Item 2.02 Results of Operations and Financial Condition.
On February 27, 2025, Collegium Pharmaceutical, Inc. (the “Company”) issued a press release announcing its financial results for the quarterly period and fiscal year ended December 31, 2024. The full text of the press release issued in connection with the announcement is attached hereto as Exhibit 99.1 and is being furnished, not filed, under Item 2.02 of this Current Report on Form 8-K.
Item 5.02 Departure of Directors or Principal Officers; Election of Directors; Appointment of Principal Officers.
On February 27, 2025, the Company announced that Shirley Kuhlmann, Executive Vice President, Chief Administrative Officer, General Counsel & Secretary of the Company will step down from her positions at the Company effective March 7, 2025. Ms. Kuhlmann’s departure will be treated as a termination without cause pursuant to the terms of her existing employment agreement with the Company.
Item 7.01 Regulation FD Disclosure.
On February 27, 2025, Collegium Pharmaceutical, Inc. released an earnings presentation. The presentation is attached hereto as Exhibit 99.2 and is being furnished, not filed, under Item 7.01 of this Current Report on Form 8-K.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit |
| |
No. | Description | |
99.1 | ||
99.2 | ||
104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Collegium Pharmaceutical, Inc. | ||
By: | /s/ Colleen Tupper | |
Colleen Tupper | ||
Executive Vice President and Chief Financial Officer |
Dated: February 27, 2025
Exhibit 99.1
Collegium Reports Record Fourth Quarter and Full-Year 2024 Financial Results
– Generated Record Quarterly and Full-Year Net Revenue of $181.9 Million and $631.4 Million –
– Reported Quarterly Jornay PM® Net Revenue of $29.3 Million and Pro Forma Full-Year Net Revenue of $100.7
Million –
– Achieved Quarterly and Full-Year GAAP Net Income of $12.5 Million and $69.2 Million –
– Delivered Record Quarterly and Full-Year Adjusted EBITDA of $107.7 Million and $401.2 Million –
– Ended 2024 with Cash, Cash Equivalents and Marketable Securities of $162.8 Million;
Repurchased $60.0 Million in Shares in 2024 –
– Reaffirmed Full-Year 2025 Guidance –
– Conference Call Scheduled for Today at 4:30 p.m. ET –
STOUGHTON, Mass., February 27, 2025 -- Collegium Pharmaceutical, Inc. (Nasdaq: COLL) today reported its financial results for the quarter and full year ended December 31, 2024, and provided a business update.
“2024 was a year of strong execution for Collegium, marked by robust performance in our pain portfolio and the addition of Jornay PM, establishing our presence in neuropsychiatry and reaffirming our commitment to helping improve the lives of people living with serious medical conditions. This was made possible thanks to the dedication of our talented team,” said Vikram Karnani, President and Chief Executive Officer. “We drove record financial results in 2024 and are poised for a new phase of growth in 2025 and beyond. We are focused on growing Jornay PM, maximizing our pain portfolio, and strategically deploying capital to create value and continue to build a leading, diversified biopharmaceutical company.”
“We are proud to have delivered on our financial commitments and strategic priorities for 2024, including growing total revenue by 11% and adjusted EBITDA by 9%, generating robust operating cash flows in a year that we completed an acquisition, and deploying capital to expand and diversify our business while executing $60 million in share repurchases,” said Colleen Tupper, Chief Financial Officer. “We are in a position of financial strength, ending the year with net debt to adjusted EBITDA of less than two times. We are committed to creating long-term value for our shareholders by executing on our commercial priorities and strategically deploying capital in a disciplined manner.”
Business Highlights
● | Grew Belbuca® total prescriptions 5.6% year-over-year and 2.9% quarter-over-quarter in the 2024 Quarter. Belbuca net revenue was a record $55.2 million in the 2024 Quarter, up 12% year-over-year. |
● | Xtampza® ER net revenue was a record $51.5 million in the 2024 Quarter, up 6% year-over-year. |
● | Appointed Nancy S. Lurker to Collegium’s Board of Directors, effective February 4, 2025. Ms. Lurker most recently served as President and Chief Executive Officer of EyePoint Pharmaceuticals, Inc. until 2023, when she transitioned to the role of Executive-Vice Chair of its Board of Directors. |
● | In 2024, repurchased $60.0 million in shares, including $25.0 million repurchased in the fourth quarter of 2024 and $35.0 million repurchased through an accelerated share repurchase program in May 2024. |
Financial Guidance for 2025
The Company reaffirms its full-year 2025 guidance for Product Revenues, Net, Adjusted Operating Expenses and Adjusted EBITDA:
Product Revenues, Net | $735.0 to $750.0 million |
Adjusted Operating Expenses (Excluding Stock-Based Compensation) | $220.0 to $230.0 million |
Adjusted EBITDA (Excluding Stock-Based Compensation) | $435.0 to $450.0 million |
Financial Results for Quarter Ended December 31, 2024
● | Product revenues, net were $181.9 million for the 2024 Quarter, compared to $149.7 million for the quarter ended December 31, 2023 (the 2023 Quarter), representing a 22% increase year-over-year. |
● | GAAP operating expenses were $60.2 million for the 2024 Quarter, compared to $32.9 million for the 2023 Quarter, representing an 83% increase year-over-year. Adjusted operating expenses, which exclude stock-based compensation expense and other adjustments to reflect changes that occur in our business but do not represent ongoing operations, were $51.1 million for the 2024 Quarter, compared to $25.9 million for the 2023 Quarter, representing a 97% increase year-over-year. |
● | GAAP net income for the 2024 Quarter was $12.5 million, with $0.39 GAAP earnings per share (basic) and $0.36 GAAP earnings per share (diluted), compared to GAAP net income for the 2023 Quarter of $31.9 million, with $0.99 GAAP earnings per share (basic) and $0.82 GAAP earnings per share (diluted). Non-GAAP adjusted net income for the 2024 Quarter was $68.5 million, with $1.75 adjusted earnings per share, compared to non-GAAP adjusted net income for the 2023 Quarter of $64.2 million, with $1.58 adjusted earnings per share. |
● | Adjusted EBITDA for the 2024 Quarter was $107.7 million, compared to $104.2 million for the 2023 Quarter, representing a 3% increase year-over-year. |
● | The Company exited the 2024 Quarter with cash, cash equivalents and marketable securities of $162.8 million, down from $310.5 million as of December 31, 2023. During 2024, $200.0 million of cash on hand funded the acquisition of Ironshore Therapeutics and $60.0 million funded share repurchases as part of the Company’s share repurchase program. |
Financial Results for Year Ended December 31, 2024
● | Product revenues, net were $631.4 million for the year ended December 31, 2024 (FY 2024), compared to $566.8 million for the year ended December 31, 2023 (FY 2023), representing an 11% increase year-over-year. |
● | GAAP operating expenses were $207.4 million for FY 2024, compared to $159.2 million for FY 2023, representing a 30% increase year-over-year. Adjusted operating expenses, which exclude stock-based compensation expense and other adjustments to reflect changes that occur in our business but do not represent ongoing operations, were $150.6 million for FY 2024, compared to $123.6 million for FY 2023, representing a 22% increase year-over-year. |
● | GAAP net income for FY 2024 was $69.2 million, with $2.14 GAAP earnings per share (basic) and $1.86 GAAP earnings per share (diluted), compared to GAAP net income for FY 2023 of $48.2 million, with $1.43 GAAP earnings per share (basic) and $1.29 GAAP earnings per share (diluted). Non-GAAP adjusted net |
income for FY 2024 was $254.8 million, with $6.45 adjusted earnings per share, compared to non-GAAP adjusted net income for FY 2023 of $223.3 million, with $5.47 adjusted earnings per share. |
● | Adjusted EBITDA for FY 2024 was $401.2 million, compared to $367.0 million for FY 2023, representing a 9% increase year-over-year. |
Conference Call Information
The Company will host a conference call and live audio webcast on Thursday, February 27, 2025, at 4:30 p.m. ET. To access the conference call, please dial (877) 407-8037 (U.S.) or (201) 689-8037 (International) and reference the “Collegium Pharmaceutical Fourth Quarter and Full-Year 2024 Earnings Call.” An audio webcast will be accessible from the Investors section of the Company’s website: www.collegiumpharma.com. The webcast will be available for replay on the Company’s website approximately two hours after the event.
About Collegium Pharmaceutical, Inc.
Collegium is building a leading, diversified biopharmaceutical company committed to improving the lives of people living with serious medical conditions. The Company has a leading portfolio of responsible pain management medications and recently acquired Jornay PM, a treatment for ADHD, establishing a presence in neuropsychiatry. Collegium’s strategy includes growing its commercial portfolio, with Jornay PM as the lead growth driver, and deploying capital in a disciplined manner. Collegium’s headquarters are located in Stoughton, Massachusetts. For more information, please visit the Company’s website at www.collegiumpharma.com.
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; |
● | adjusted EBITDA does not reflect changes in, or cash requirements for, working capital needs; |
● | 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 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; |
● | 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; |
● | 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; and |
● | we exclude other expenses, from time to time, that are episodic in nature and do not directly correlate to the cost of operating our business on an ongoing basis. |
Adjusted Operating Expenses
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 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.
Reconciliations of adjusted EBITDA, adjusted operating expenses, adjusted net income, and adjusted earnings per share to the most directly comparable GAAP financial measures are included in this press release.
The Company has not provided a reconciliation of its full-year 2025 guidance for adjusted EBITDA or adjusted operating expenses to the most directly comparable forward-looking GAAP measures, in reliance on the unreasonable efforts exception provided under Item 10(e)(1)(i)(B) of Regulation S-K, because the Company is unable to predict, without unreasonable efforts, the timing and amount of items that would be included in such a reconciliation, including, but not limited to, stock-based compensation expense, acquisition related expense and litigation settlements. These items are uncertain and depend on various factors that are outside of the Company’s control or cannot be reasonably predicted. While the Company is unable to address the probable significance of these items, they could have a material impact on GAAP net income and operating expenses for the guidance period. A reconciliation of adjusted EBITDA or adjusted operating expenses would imply a degree of precision and certainty as to these future items that does not exist and could be confusing to investors.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as "predicts," "forecasts," "believes," "potential," "proposed,"
"continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Examples of forward-looking statements contained in this press release include, among others, statements related to our full-year 2025 financial guidance, including projected product revenue, adjusted operating expenses and adjusted EBITDA, current and future market opportunities for our products and our assumptions related thereto, expectations (financial or otherwise) and intentions, and other statements that are not historical facts. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results, performance, or achievements to differ materially from the company's current expectations, including risks relating to, among others: unknown liabilities; risks related to future opportunities and plans for our products, including uncertainty of the expected financial performance of such products; our ability to commercialize and grow sales of our products; our ability to realize the anticipated benefits associated with the acquisition of Ironshore; our ability to manage our relationships with licensors; the success of competing products that are or become available; our ability to maintain regulatory approval of our products, and any related restrictions, limitations, and/or warnings in the label of our products; the size of the markets for our products, and our ability to service those markets; our ability to obtain reimbursement and third-party payor contracts for our products; the rate and degree of market acceptance of our products; the costs of commercialization activities, including marketing, sales and distribution; changing market conditions for our products; the outcome of any patent infringement or other litigation that may be brought by or against us; the outcome of any governmental investigation related to our business; our ability to secure adequate supplies of active pharmaceutical ingredient for each of our products and manufacture adequate supplies of commercially saleable inventory; our ability to obtain funding for our operations and business development; regulatory developments in the U.S.; our expectations regarding our ability to obtain and maintain sufficient intellectual property protection for our products; our ability to comply with stringent U.S. and foreign government regulation in the manufacture of pharmaceutical products, including U.S. Drug Enforcement Agency (DEA), compliance; our customer concentration; and the accuracy of our estimates regarding expenses, revenue, capital requirements and need for additional financing. These and other risks are described under the heading "Risk Factors" in our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and other filings with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
Investor Contacts:
Ian Karp
Vice President, Investor Relations
ir@collegiumpharma.com
Danielle Jesse
Director, Investor Relations
ir@collegiumpharma.com
Media Contact:
Cheryl Wheeler
Head of Corporate Communications
communications@collegiumpharma.com
Collegium Pharmaceutical, Inc.
Unaudited Selected Consolidated Balance Sheet Information
(in thousands)
| | December 31, | | December 31, | ||
|
| 2024 | | 2023 | ||
Cash and cash equivalents | | $ | 70,565 | | $ | 238,947 |
Marketable securities | | | 92,198 | | | 71,601 |
Accounts receivable, net | |
| 228,540 | | | 179,525 |
Inventory | |
| 35,560 | | | 32,332 |
Prepaid expenses and other current assets | |
| 30,394 | | | 15,195 |
Property and equipment, net | | | 14,329 | | | 15,983 |
Operating lease assets | |
| 5,822 | | | 6,029 |
Intangible assets, net | |
| 891,402 | | | 421,708 |
Restricted cash | |
| 26,047 | | | 1,047 |
Deferred tax assets | | | 98,033 | | | 26,259 |
Other noncurrent assets | |
| 8,368 | | | 825 |
Goodwill | | | 162,333 | | | 133,857 |
Total assets | | $ | 1,663,591 | | $ | 1,143,308 |
| | | | | | |
Accounts payable and accrued liabilities | |
| 76,058 | | | 46,263 |
Accrued rebates, returns and discounts | |
| 338,642 | | | 227,331 |
Business combination consideration payable | | | 28,956 | | | — |
Term notes payable | |
| 615,316 | | | 405,046 |
Convertible senior notes | | | 237,172 | | | 262,125 |
Operating lease liabilities | |
| 6,810 | | | 7,112 |
Deferred royalty obligation | | | 120,613 | | | — |
Deferred revenue | | | 10,000 | | | — |
Contingent consideration | | | 1,182 | | | — |
Shareholders’ equity | |
| 228,842 | | | 195,431 |
Total liabilities and shareholders’ equity | | $ | 1,663,591 | | $ | 1,143,308 |
Collegium Pharmaceutical, Inc.
Unaudited Condensed Statements of Operations
(in thousands, except share and per share amounts)
| Three Months Ended December 31, | | Years Ended December 31, | ||||||||
| 2024 | | 2023 | | 2024 | | 2023 | ||||
Product revenues, net | $ | 181,949 | | $ | 149,745 | | $ | 631,449 | | $ | 566,767 |
Cost of product revenues | | | | | | | | | | | |
Cost of product revenues (excluding intangible asset amortization) | | 28,190 | | | 20,601 | | | 88,801 | | | 94,838 |
Intangible asset amortization and impairment | | 55,471 | | | 34,514 | | | 165,304 | | | 145,760 |
Total cost of product revenues |
| 83,661 | |
| 55,115 | |
| 254,105 | |
| 240,598 |
Gross profit | | 98,288 | | | 94,630 | | | 377,344 | | | 326,169 |
Operating expenses | | | | | | | | | | | |
Selling, general and administrative |
| 63,091 | |
| 32,942 | |
| 210,363 | |
| 159,208 |
Gain on fair value remeasurement of contingent consideration | | (2,914) | | | — | | | (2,914) | | | — |
Total operating expenses |
| 60,177 | |
| 32,942 | |
| 207,449 | |
| 159,208 |
Income from operations |
| 38,111 | |
| 61,688 | |
| 169,895 | |
| 166,961 |
Interest expense |
| (22,654) | |
| (19,281) | |
| (73,974) | |
| (83,339) |
Interest income | | 1,812 | | | 4,303 | | | 13,976 | | | 15,615 |
Loss on extinguishment of debt | | — | | | — | | | (11,329) | | | (23,504) |
Income before income taxes | | 17,269 | | | 46,710 | | | 98,568 | | | 75,733 |
Provision for income taxes | | 4,733 | | | 14,770 | | | 29,378 | | | 27,578 |
Net income | $ | 12,536 | | $ | 31,940 | | $ | 69,190 | | $ | 48,155 |
| | | | | | | | | | | |
Earnings per share — basic | $ | 0.39 | | $ | 0.99 | | $ | 2.14 | | $ | 1.43 |
Weighted-average shares — basic | | 32,078,621 | | | 32,301,211 | | | 32,273,850 | | | 33,741,213 |
| | | | | | | | | | | |
Earnings per share — diluted | $ | 0.36 | | $ | 0.82 | | $ | 1.86 | | $ | 1.29 |
Weighted-average shares — diluted | | 40,109,649 | | | 41,279,981 | | | 40,424,180 | | | 41,788,125 |
Collegium Pharmaceutical, Inc.
Reconciliation of GAAP Net Income to Adjusted EBITDA
(in thousands)
(unaudited)
|
| Three Months Ended December 31, |
| Years Ended December 31, | ||||||||
| | 2024 | | 2023 | | 2024 | | 2023 | ||||
GAAP net income |
| $ | 12,536 |
| $ | 31,940 |
| $ | 69,190 |
| $ | 48,155 |
Adjustments: | |
|
| |
|
| |
|
| |
|
|
Interest expense | |
| 22,654 | |
| 19,281 | |
| 73,974 | |
| 83,339 |
Interest income | |
| (1,812) | |
| (4,303) | |
| (13,976) | |
| (15,615) |
Loss on extinguishment of debt | |
| — | |
| — | |
| 11,329 | |
| 23,504 |
Provision for income taxes | |
| 4,733 | |
| 14,770 | |
| 29,378 | |
| 27,578 |
Depreciation | |
| 1,041 | |
| 949 | |
| 3,856 | |
| 3,496 |
Amortization | |
| 55,471 | |
| 34,514 | |
| 165,304 | |
| 145,760 |
Stock-based compensation | |
| 7,596 | |
| 7,002 | |
| 32,400 | |
| 27,136 |
Litigation settlements | |
| — | |
| — | |
| — | |
| 8,500 |
Recognition of step-up basis in inventory | |
| 3,968 | |
| — | |
| 5,269 | |
| 15,116 |
CEO transition expense | |
| — | |
| — | |
| 3,051 | |
| — |
Acquisition related expenses | |
| 4,443 | |
| — | |
| 24,329 | |
| — |
Gain on fair value remeasurement of contingent consideration | |
| (2,914) | |
| — | |
| (2,914) | |
| — |
Total adjustments | | $ | 95,180 | | $ | 72,213 | | $ | 332,000 | | $ | 318,814 |
Adjusted EBITDA | | $ | 107,716 | | $ | 104,153 | | $ | 401,190 | | $ | 366,969 |
Collegium Pharmaceutical, Inc.
Reconciliation of GAAP Operating Expenses to Adjusted Operating Expenses
(in thousands)
(unaudited)
|
| Three Months Ended December 31, |
| Years Ended December 31, | ||||||||
| | 2024 | | 2023 | | 2024 | | 2023 | ||||
GAAP operating expenses |
| $ | 60,177 |
| $ | 32,942 |
| $ | 207,449 |
| $ | 159,208 |
Adjustments: | |
|
| |
|
| |
|
| |
|
|
Stock-based compensation | |
| 7,596 | |
| 7,002 | |
| 32,400 | |
| 27,136 |
Litigation settlements | |
| — | |
| — | |
| — | |
| 8,500 |
CEO transition expense | |
| — | |
| — | |
| 3,051 | |
| — |
Acquisition related expenses | |
| 4,443 | |
| — | |
| 24,329 | |
| — |
Gain on fair value remeasurement of contingent consideration | |
| (2,914) | |
| — | |
| (2,914) | |
| — |
Total adjustments | | $ | 9,125 | | $ | 7,002 | | $ | 56,866 | | $ | 35,636 |
Adjusted operating expenses | | $ | 51,052 | | $ | 25,940 | | $ | 150,583 | | $ | 123,572 |
Collegium Pharmaceutical, Inc.
Reconciliation of GAAP Net Income to Adjusted Net Income and Adjusted Earnings Per Share
(in thousands, except share and per share amounts)
(unaudited)
| Three Months Ended December 31, | | Years Ended December 31, | ||||||||
| 2024 | | 2023 | | 2024 | | 2023 | ||||
GAAP net income | $ | 12,536 | | $ | 31,940 | | $ | 69,190 | | $ | 48,155 |
Adjustments: | | | | | | | | | | | |
Non-cash interest expense | | 4,664 | | | 1,963 | | | 9,729 | | | 8,635 |
Loss on extinguishment of debt | | — | | | — | | | 11,329 | | | 23,504 |
Amortization | | 55,471 | | | 34,514 | | | 165,304 | | | 145,760 |
Stock-based compensation | | 7,596 | | | 7,002 | | | 32,400 | | | 27,136 |
Litigation settlements | | — | | | — | | | — | | | 8,500 |
Recognition of step-up basis in inventory | | 3,968 | | | — | | | 5,269 | | | 15,116 |
CEO transition expense | | — | | | — | | | 3,051 | | | — |
Acquisition related expenses | | 4,443 | | | — | | | 24,329 | | | — |
Gain on fair value remeasurement of contingent consideration | | (2,914) | | | — | | | (2,914) | | | — |
Income tax effect of above adjustments (1) | | (17,245) | | | (11,252) | | | (62,880) | | | (53,526) |
Total adjustments | $ | 55,983 | | $ | 32,227 | | $ | 185,617 | | $ | 175,125 |
Non-GAAP adjusted net income | $ | 68,519 | | $ | 64,167 | | $ | 254,807 | | $ | 223,280 |
| | | | | | | | | | | |
Adjusted weighted-average shares — diluted (2) | | 40,109,649 | | | 41,279,982 | | | 40,424,180 | | | 41,788,125 |
Adjusted earnings per share (2) | $ | 1.77 | | $ | 1.58 | | $ | 6.45 | | $ | 5.47 |
(1) | The income tax effect of the adjustments was calculated by applying our blended federal and state statutory rate to the items that have a tax effect. The blended federal and state statutory rate for the three months ended December 31, 2024 and 2023 were 25.3% and 25.9%, respectively; and the blended federal and state statutory rate for the years ended December 31, 2024 and 2023 were 26.5% and 25.9%, respectively. As such, the non-GAAP effective tax rates for the three months ended December 31, 2024 and 2023 were 23.5% and 25.9%, respectively; and the non-GAAP effective tax rates for the years ended December 31, 2024 and 2023 were 25.3% and 23.4%, respectively. |
(2) | Adjusted weighted-average shares - diluted were calculated using the “if-converted” method for our convertible 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 December 31, 2024 and 2023, adjusted weighted-average shares – diluted includes 6,606,305 and 7,509,104 shares, respectively, attributable to our convertible notes. For the years ended December 31, 2024 and 2023, adjusted weighted-average shares – diluted includes 6,606,305 and 6,793,421 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. |
Q4 and FY2024 Earnings Report February 27, 2025 | Nasdaq: COLL Healthier people. Stronger communities. |
Forward-Looking Statements This presentation contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as "predicts," "forecasts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Examples of forward-looking statements contained in this presentation include, among others, statements related to our full-year 2025 financial guidance, including projected product revenue, adjusted operating expenses and adjusted EBITDA, current and future market opportunities for our products and our assumptions related thereto, expectations (financial or otherwise) and intentions, and other statements that are not historical facts. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results, performance, or achievements to differ materially from the company's current expectations, including risks relating to, among others: unknown liabilities; risks related to future opportunities and plans for our products, including uncertainty of the expected financial performance of such products; our ability to commercialize and grow sales of our products; our ability to manage our relationships with licensors; the success of competing products that are or become available; our ability to maintain regulatory approval of our products, and any related restrictions, limitations, and/or warnings in the label of our products; the size of the markets for our products, and our ability to service those markets; our ability to obtain reimbursement and third-party payor contracts for our products; the rate and degree of market acceptance of our products; the costs of commercialization activities, including marketing, sales and distribution; changing market conditions for our products; the outcome of any patent infringement or other litigation that may be brought by or against us; the outcome of any governmental investigation related to our business; our ability to secure adequate supplies of active pharmaceutical ingredient for each of our products and manufacture adequate supplies of commercially saleable inventory; our ability to obtain funding for our operations and business development; regulatory developments in the U.S.; our expectations regarding our ability to obtain and maintain sufficient intellectual property protection for our products; our ability to comply with stringent U.S. and foreign government regulation in the manufacture of pharmaceutical products, including U.S. Drug Enforcement Agency, or DEA, compliance; our customer concentration; and the accuracy of our estimates regarding expenses, revenue, capital requirements and need for additional financing. These and other risks are described under the heading "Risk Factors" in our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and other filings with the SEC. Any forward-looking statements that we make in this presentation speak only as of the date of this presentation. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this presentation. 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. In this presentation, we discuss the following financial measures that are not calculated in accordance with GAAP, to supplement our consolidated financial statements presented on a GAAP basis. 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; • adjusted EBITDA does not reflect changes in, or cash requirements for, working capital needs; • 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 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; • 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; • 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; and • we exclude other expenses, from time to time, that are episodic in nature and do not directly correlate to the cost of operating our business on an ongoing basis. Adjusted Operating Expenses 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 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. Reconciliations of adjusted EBITDA and adjusted operating expenses to the most directly comparable GAAP financial measures are included in this presentation. The Company has not provided a reconciliation of its full-year 2025 guidance for adjusted EBITDA or adjusted operating expenses to the most directly comparable forward-looking GAAP measures, in reliance on the unreasonable efforts exception provided under Item 10(e)(1)(i)(B) of Regulation S-K, because the Company is unable to predict, without unreasonable efforts, the timing and amount of items that would be included in such a reconciliation, including, but not limited to, stock-based compensation expense, acquisition related expense and litigation settlements. These items are uncertain and depend on various factors that are outside of the Company’s control or cannot be reasonably predicted. While the Company is unable to address the probable significance of these items, they could have a material impact on GAAP net income and operating expenses for the guidance period. A reconciliation of adjusted EBITDA or adjusted operating expenses would imply a degree of precision and certainty as to these future items that does not exist and could be confusing to investors. |
Business Update Vikram Karnani, President & Chief Executive Officer |
4 Successful Track Record in Building a Leading, Diversified Biopharmaceutical Company Strong Commercial Execution Robust Financial Results Strategic Capital Deployment Adjusted EBITDA4 $197M Share repurchases conducted since inception3 $1.6B Invested in business development to date5 $277M1 $464M2 $567M2 $631M3 2021 2022 2023 2024 Product Revenues, Net $118M1 $266M2 $367M2 $401M3 2021 2022 2023 2024 1. This financial data was provided by Collegium in its Annual Report on Form 10-K filed with the SEC on February 23, 2023. 2. This financial data was provided by Collegium in its Annual Report on Form 10-K filed with the SEC on February 22, 2024. 3. This financial data was provided by Collegium in its Annual Report on Form 10-K filed with the SEC on February 27, 2025. 4. Represents a non-GAAP financial measure. Refer to “Non-GAAP Financial Measures” on slide 2. 5. Represents the sum of the purchase price consideration paid for the Nucynta Acquisition in 2020, the BDSI Acquisition in 2022, and the upfront cash paid to complete the Ironshore acquisition in 2024 as disclosed on Annual Report on Form 10-K filed with the SEC on February 25, 2021, Annual Report on Form 10-K filed with the SEC on February 23, 2023, and Form 8-K filed with the SEC on September 4, 2024, respectively. |
5 Recent Business Highlights DROVE MOMENTUM IN COMMERCIAL PORTFOLIO 1. IQVIA NPA through December 31, 2024. 2. This financial data was provided by Collegium in its Annual Report on Form 10-K filed with the SEC on February 27, 2025. 3. Nucynta exclusivity extended from June 2025 to January 2027 and Nucynta ER exclusivity extended from June 2025 to June 2027. 4. Represents a non-GAAP financial measure. Refer to “Non-GAAP Financial Measures” on slide 2. 5. Net debt/adjusted EBITDA is calculated based on financial data provided by Collegium in its Form 8-K and Form 10-K filed with the SEC on February 27, 2025. 29% YoY growth in Q4’24 prescriptions1 1.5-2 yr exclusivity extension3 5% YoY growth in 2024 net revenue2 Leading Pain Portfolio Product Revenues, Net $567M In 2023 $631M In 2024 +11% Adjusted EBTIDA4 $367M In 2023 $401M In 2024 Acquired Ironshore Therapeutics, diversifying portfolio and expanding into neuropsychiatry <2x net debt to adjusted EBITDA at end of 20244,5 $60M share repurchases conducted in 20242 +9% STRATEGICALLY DEPLOYED CAPITAL AND MANAGED THE BALANCE SHEET DELIVERED SIGNIFICANT TOP-AND BOTTOM-LINE GROWTH2 |
DRIVE SIGNIFICANT Jornay PM® Growth • Invest in Jornay PM to support near-term growth and create significant momentum in 2026 and beyond • Raise awareness in patients and caregivers to drive prescription growth • Expand commercial presence in neuropsychiatry 6 Next Phase of Growth – Building on a Successful Strategy STRATEGICALLY Deploy Capital • Expand portfolio through disciplined business development • Rapidly pay down debt and opportunistically repurchase shares MAXIMIZE Pain Portfolio • Maximize and enhance durability of pain portfolio • Generate durable operating cash flow from pain portfolio |
Commercial Update Scott Dreyer, Executive Vice President & Chief Commercial Officer |
8 Expansion into Neuropsychiatry Offers Compelling Opportunity in Large and Growing Attention Deficit Hyperactivity Disorder (ADHD) Market Growing Total ADHD Prescriptions3 ADHD Prevalence1 ~6.5M Pediatric and Adolescents ~15.5M Adults ~20K HCPs writing 1/3 of prescriptions4 Methylphenidate Patient Mix Skewed Toward Pediatric & Adolescents2 Pediatricians 44% Psychiatry 38% PCP 10% Other 8% Top HCP Specialties5 1. Danielson et al. 2024; Staley et al. 2024. 2. Long-acting methylphenidate, IQVIA NPA Extended Insights, MAT Nov 2024. 3. IQVIA NPA. 4. Long-acting stimulant, ZS Associates, Jornay PM GtM Strategy Project, 2024. 5. Represents Collegium targets prescriber count by specialty; IQVIA Xponent 2024. ~70% Pediatric and Adolescents ~30% Adults Concentrated Prescriber Base +6% CAGR from 2019-2024 |
Jornay PM Recognized for Symptom Control by HCPS 9 Jornay PM: Strong Brand Fundamentals from HCP’s Perspective1 1. ADHD Long-Acting Stimulant Market ATU2 Q4, 2023. Jornay PM Considered Highly Favorable and Patient/Caregiver Requests Influence Prescribing #1 recognized branded ADHD medication for achieving all-day symptom control with one dose #1 recognized branded ADHD medication for controlling after school/work and evening symptoms #1 highest rated branded ADHD medication in terms of product favorability Patient/Caregiver request is a top influencer of trial by HCP |
138K 160K 178K Q4'23 Q3'24 Q4'24 10 Jornay PM Generated Significant Growth in 2024 Marked by Acceleration Under Collegium’s Ownership STRONG AND GROWING PRESCRIBER BASE2 ACCELERATION IN QUARTERLY PRESCRIPTIONS1 16K 17K 18K 19K 21K 21K 23K 24K Q1'23Q2'23Q3'23Q4'23Q1'24Q2'24Q3'24Q4'24 +26% +11% 1. IQVIA NPA through December 2024. 2. IQVIA Xponent through December 2024; approximate quarterly prescriber counts. SIGNIFICANT GROWTH IN ANNUAL PRESCRIPTIONS1 With Collegium resources and targeted investment, Jornay PM is poised for significant growth in the ADHD market 37K 144K 207K 309K 487K 636K 2019 2020 2021 2022 2023 2024 +49% +58% +31% +29% |
11 Investing in Jornay PM to Drive Revenue Growth Increase Awareness and Adoption with Expanded Set of Prescribers • Expand and optimize salesforce to cover full market opportunity • Leverage non-personal promotion to increase awareness and use of Jornay PM Raise Caregiver and Patient Awareness to Drive HCP Request • Initiate digital marketing and social media strategies to target caregivers and patients • Develop and launch new patient support resources $100.7M1 >$135M 2024 2025E JORNAY PM NEAR-TERM REVENUE EXPECTATIONS COMMERCIAL PRIORITIES FOCUSED ON GROWTH 2025 investments into Jornay PM expected to support near-term growth and create significant momentum in 2026 and beyond +>34% 1. Represents pro forma Jornay PM net revenue. Collegium recognized $37.2M of Jornay PM net revenue in 2024 following the close of the Ironshore Therapeutics acquisition on September 4, 2024. |
12 Well Positioned to Maximize and Enhance Durability of Pain Portfolio 1. IQVIA NPA through December 31, 2024. 2. ATU (Awareness, Trial, & Usage) Market Research Study, fielded Q4 2022. #1 highest rated branded ER opioid in terms of product differentiation and favorability 74% of surveyed target HCPs plan to increase prescribing STRONG BRAND FUNDAMENTALS2 #1 highest rated ER oxycodone in terms of product differentiation and favorability 48% of surveyed target HCPs plan to increase prescribing SUCCESSFUL COMMERCIAL EXECUTION OF GROWTH STRATEGY +2.6% QoQ growth in Q4’24 prescriptions1 +5.6% YoY growth in Q4’24 prescriptions1 |
Financial Highlights Colleen Tupper, Executive Vice President & Chief Financial Officer |
Achievement of 2024 Financial Commitments Sets Strong Foundation for 2025 and Beyond ACHIEVED 2024 GUIDANCE WITH RECORD FINANCIAL RESULTS1 REMAIN COMMITTED TO STRATEGIC CAPITAL DEPLOYMENT 2025 GUIDANCE REFLECTS SIGNIFICANT TOP- AND BOTTOM-LINE GROWTH3 14 1. This financial data was provided by Collegium in its Annual Report on Form 10-K filed with the SEC on February 27, 2025. 2. Represents a non-GAAP financial measure. Refer to “Non-GAAP Financial Measures” on slide 2. 3. This financial data was calculated based on data provided by Collegium in its press release filed with the SEC on February 27, 2025. 2025E represents the mid-point of 2025 financial guidance ranges. $567M $631M 2023 2024 Product Revenues, Net $367M $401M 2023 2024 Adjusted EBTIDA2 +11% +9% $631M $743M 2024 2025E Product Revenues, Net $401M $443M 2024 2025E Adjusted EBTIDA2 +18% +10% Expand portfolio through disciplined business development Rapidly pay down debt and opportunistically repurchase shares |
2025 Financial Guidance Reflects Strong Top- and Bottom-Line Growth 1. Represents a non-GAAP financial measure. Refer to “Non-GAAP Financial Measures” on slide 2. 2. This financial data was provided by Collegium in its press release filed with the SEC on February 27, 2025. 3. This financial data is calculated based on data provided by Collegium in its press release filed with the SEC on February 27, 2025, and represents the percent change of the mid-point of 2025 financial guidance ranges compared to 2024 financial results. 16 Guidance Range2 YoY Change3 Product Revenues, Net $735 – 750M +18% Adjusted EBITDA1 $435 – 450M +10% Adjusted Operating Expenses1 $220 – 230M +49% • Revenue growth expected to be driven by >$135M in Jornay PM net revenue in 2025 and durable pain portfolio performance • Continued adjusted EBITDA growth to generate operating cash flows • Increase in adjusted operating expenses reflects investments into Jornay PM salesforce and marketing to support near-term growth and create significant momentum in 2026 and beyond • Jornay PM investment impact on adjusted EBITDA margin is expected to improve beginning in 2026 |
Closing Remarks Vikram Karnani, President & Chief Executive Officer |
2025 and Beyond: Jornay PM Leading Collegium’s Next Phase of Growth 19 GROWING REVENUE CREATING VALUE FOR SHAREHOLDERS BY: INCREASING PROFITABILITY GENERATING STRONG CASH FLOWS STRATEGICALLY DEPLOYING CAPITAL |
Q&A |
Non-GAAP Reconciliations |