8-K
COLLEGIUM PHARMACEUTICAL, INC (COLL)
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): **** May 9, 2024
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 May 9, 2024, Collegium Pharmaceutical, Inc. issued a press release announcing its financial results for the quarterly period ended March 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 7.01Regulation FD Disclosure.
On May 9, 2024, 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 | | Press Release, dated May 9, 2024 |
| 99.2 | | Earnings Presentation, dated May 9, 2024 |
| 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.
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|---|---|---|
| | Collegium Pharmaceutical, Inc. | |
| | | |
| | By: | /s/ Colleen Tupper |
| | | Colleen Tupper |
| | | Executive Vice President and Chief Financial Officer |
Dated: May 9, 2024
Exhibit 99.1
Collegium Reports First Quarter 2024 Financial Results
– Generated Q1’24 Net Revenue of $144.9 Million –
– Delivered Q1’24 Record Belbuca^®^ Revenue of $50.7 Million; Total Prescriptions Up 4.2% Year-over-Year –
– Achieved Q1’24 GAAP Net Income of $27.7 Million vs. Q1’23 GAAP Net Loss of $(17.4) Million –
– Delivered Q1’24 Adjusted EBITDA of $92.4 Million, Up 5% Year-over-Year –
– Board of Directors Authorized $35.0 Million Accelerated Share Repurchase Program –
– Reaffirmed Full-Year 2024 Guidance –
– Conference Call Scheduled for Today at 4:30 p.m. ET –
STOUGHTON, Mass., May 9, 2024 -- Collegium Pharmaceutical, Inc. (Nasdaq: COLL), a leading, diversified specialty pharmaceutical company committed to improving the lives of people living with serious medical conditions, today reported its financial results for the quarter ended March 31, 2024, and provided a corporate update.
“Thanks to our dedicated team and successful first quarter, Collegium is progressing towards another year of record financial performance,” said Joe Ciaffoni, President and Chief Executive Officer of Collegium. “Our recently announced authorized generic agreement with Hikma meaningfully improves the value of the Nucynta Franchise, which, combined with our healthy balance sheet, fortifies our financial position and gives us confidence in our ability to create value for our shareholders. I am confident the organization is well positioned to deliver on its financial and capital deployment priorities in 2024 by focusing on operational execution.”
“We delivered strong first quarter results marked by record Belbuca revenue, managed expenses and robust cash flows, positioning us to achieve our 2024 financial guidance,” said Colleen Tupper, Chief Financial Officer of Collegium. “Our outlook in 2025 and beyond continues to improve. We are committed to deploying capital to create value for our shareholders as demonstrated by the redemption of the total principal amount of our 2026 convertible notes and our newly announced $35.0 million Accelerated Share Repurchase program.”
Business Highlights
| ● | Grew Belbuca total prescriptions 4.2% in the quarter ended March 31, 2024, compared to the prior year quarter. Belbuca net revenue was a record $50.7 million, up 15% year-over-year. |
|---|---|
| ● | Achieved Xtampza^®^ ER gross-to-net of 53.6% in the quarter ended March 31, 2024. Xtampza ER gross-to-net is expected to be in the range of 56% to 58% for the full-year 2024. |
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| ● | Presented four posters at the American Academy of Pain Medicine (AAPM) Annual Meeting in March 2024. |
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| ● | In April, called all $26.4 million aggregate principal amount of Collegium’s outstanding 2.625% Convertible Senior Notes due in 2026 for redemption on Friday, June 14, 2024. |
| --- | --- |
| ● | In April, announced Collegium has entered into an authorized generic agreement with Hikma Pharmaceuticals USA Inc., pursuant to which Hikma will have the exclusive right to sell the authorized generic versions of Nucynta^®^ and Nucynta^®^ ER in the United States. |
| --- | --- |
| ● | In May, announced that Joe Ciaffoni will step down as President and Chief Executive Officer (CEO) of the Company effective May 24, 2024. Mr. Ciaffoni will serve as a member of the Board of Directors of the Company until the upcoming 2024 Annual Meeting of Shareholders and will not stand for re-election at the meeting. To ensure a seamless transition, Michael Heffernan, founder, former CEO and Chairman of the Board will serve as Interim President and CEO until a new CEO is appointed by the Board of Directors. |
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| ● | Board of Directors authorized a $35.0 million Accelerated Share Repurchase program. |
| --- | --- |
Financial Guidance for 2024
| ● | The Company reaffirms its full-year 2024 guidance for Product Revenues, Net, Adjusted Operating Expenses and Adjusted EBITDA: |
|---|
| Product Revenues, Net | $580.0 to $595.0 million |
|---|---|
| Adjusted Operating Expenses<br><br>(Excluding Stock-Based Compensation) | $120.0 to $125.0 million |
| Adjusted EBITDA<br><br>(Excluding Stock-Based Compensation) | $380.0 to $395.0 million |
Financial Results for Quarter Ended March 31, 2024
| ● | Product revenues, net were $144.9 million for the quarter ended March 31, 2024 (the 2024 Quarter), compared to $144.8 million for the quarter ended March 31, 2023 (the 2023 Quarter), relatively flat year-over-year. |
|---|---|
| ● | GAAP operating expenses were $42.0 million for the 2024 Quarter, compared to $52.8 million for the 2023 Quarter, representing a 20% decrease 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 $34.5 million for the 2024 Quarter, compared to $38.2 million for the 2023 Quarter, representing a 10% decrease year-over-year. |
| --- | --- |
| ● | GAAP net income for the 2024 Quarter was $27.7 million, with $0.86 GAAP earnings per share (basic) and $0.71 GAAP earnings per share (diluted), compared to GAAP net loss for the 2023 Quarter of $(17.4) million, with $(0.51) GAAP loss per share (basic and diluted). Non-GAAP adjusted net income for the 2024 Quarter was $58.8 million, with $1.45 adjusted earnings per share, compared to non-GAAP adjusted net income for the 2023 Quarter of $51.7 million, with $1.32 adjusted earnings per share. |
| --- | --- |
| ● | Adjusted EBITDA for the 2024 Quarter was $92.4 million, compared to $87.6 million for the 2023 Quarter, representing a 5% increase year-over-year. |
| --- | --- |
| ● | The Company exited the 2024 Quarter with cash, cash equivalents and marketable securities of $318.0 million, up from $310.5 million as of December 31, 2023. |
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Conference Call Information
The Company will host a conference call and live audio webcast on Thursday, May 9, 2024, 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 Q1 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 a leading, diversified specialty pharmaceutical company committed to improving the lives of people living with serious medical conditions. Collegium’s headquarters are located in Stoughton, Massachusetts. For more information, please visit the Company’s website at www.collegiumpharma.com.
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 our quarterly and annual reports, earnings press releases and conference calls, we may 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; |
|---|---|
| ● | 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; |
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| ● | adjusted EBITDA does not reflect the benefit from or provision for income taxes or the cash requirements to pay taxes; |
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| ● | adjusted EBITDA does not reflect historical cash expenditures or future requirements for capital expenditures or contractual commitments; |
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| ● | 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; |
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| ● | 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; |
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| ● | 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 |
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| ● | 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. |
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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 2024 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 2024 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 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 Contact: Christopher James, M.D. Vice President, Investor Relations ir@collegiumpharma.com
Media Contact: Marissa Samuels Vice President, Corporate Communications communications@collegiumpharma.com
Collegium Pharmaceutical, Inc.
Unaudited Selected Consolidated Balance Sheet Information
(in thousands)
| | | | | | | |
|---|---|---|---|---|---|---|
| | | March 31, | | December 31, | ||
| | 2024 | | 2023 | |||
| Cash and cash equivalents | | $ | 228,610 | | $ | 238,947 |
| Marketable securities | | | 89,438 | | | 71,601 |
| Accounts receivable, net | | 174,693 | | | 179,525 | |
| Inventory | | 31,276 | | | 32,332 | |
| Prepaid expenses and other current assets | | 15,243 | | | 15,195 | |
| Property and equipment, net | | | 15,457 | | | 15,983 |
| Operating lease assets | | 5,813 | | | 6,029 | |
| Intangible assets, net | | 387,191 | | | 421,708 | |
| Restricted cash | | 1,047 | | | 1,047 | |
| Deferred tax assets | | | 30,671 | | | 26,259 |
| Other noncurrent assets | | 954 | | | 825 | |
| Goodwill | | | 133,857 | | | 133,857 |
| Total assets | | $ | 1,114,250 | | $ | 1,143,308 |
| | | | | | | |
| Accounts payable and accrued liabilities | | 44,210 | | | 46,263 | |
| Accrued rebates, returns and discounts | | 217,880 | | | 227,331 | |
| Term notes payable | | 360,693 | | | 405,046 | |
| Convertible senior notes | | | 262,425 | | | 262,125 |
| Operating lease liabilities | | 6,873 | | | 7,112 | |
| Shareholders’ equity | | 222,169 | | | 195,431 | |
| Total liabilities and stockholders’ equity | | $ | 1,114,250 | | $ | 1,143,308 |
Collegium Pharmaceutical, Inc.
Unaudited Condensed Statements of Operations
(in thousands, except share and per share amounts)
| | | | | | |
|---|---|---|---|---|---|
| | Three Months Ended March 31, | ||||
| | 2024 | | 2023 | ||
| Product revenues, net | $ | 144,923 | | $ | 144,767 |
| Cost of product revenues | | | | | |
| Cost of product revenues (excluding intangible asset amortization) | | 18,950 | | | 29,899 |
| Intangible asset amortization | | 34,517 | | | 37,466 |
| Total cost of product revenues | 53,467 | | 67,365 | ||
| Gross profit | | 91,456 | | | 77,402 |
| Operating expenses | | | | | |
| Selling, general and administrative | 41,982 | | 52,775 | ||
| Total operating expenses | 41,982 | | 52,775 | ||
| Income from operations | 49,474 | | 24,627 | ||
| Interest expense | (17,339) | | (21,427) | ||
| Interest income | | 4,487 | | | 2,747 |
| Loss on extinguishment of debt | | — | | | (23,504) |
| Income (loss) before income taxes | | 36,622 | | | (17,557) |
| Provision for (benefit from) income taxes | | 8,909 | | | (131) |
| Net income (loss) | $ | 27,713 | | $ | (17,426) |
| | | | | | |
| Earnings (loss) per share — basic | $ | 0.86 | | $ | (0.51) |
| Weighted-average shares — basic | | 32,326,589 | | | 34,319,291 |
| | | | | | |
| Earnings (loss) per share — diluted | $ | 0.71 | | $ | (0.51) |
| Weighted-average shares — diluted | | 41,438,466 | | | 34,319,291 |
Collegium Pharmaceutical, Inc.
Reconciliation of GAAP Net Income (Loss) to Adjusted EBITDA
(in thousands)
(unaudited)
| | | | | | |
|---|---|---|---|---|---|
| | Three Months Ended March 31, | ||||
| | 2024 | | 2023 | ||
| GAAP net income (loss) | $ | 27,713 | | $ | (17,426) |
| Adjustments: | | | | | |
| Interest expense | | 17,339 | | | 21,427 |
| Interest income | | (4,487) | | | (2,747) |
| Loss on extinguishment of debt | | — | | | 23,504 |
| Provision for (benefit from) income taxes | | 8,909 | | | (131) |
| Depreciation | | 917 | | | 817 |
| Amortization | | 34,517 | | | 37,466 |
| Stock-based compensation | | 7,475 | | | 6,035 |
| Litigation settlements | | — | | | 8,500 |
| Recognition of step-up basis in inventory | | — | | | 10,170 |
| Total adjustments | $ | 64,670 | | $ | 105,041 |
| Adjusted EBITDA | $ | 92,383 | | $ | 87,615 |
Collegium Pharmaceutical, Inc.
Reconciliation of GAAP Operating Expenses to Adjusted Operating Expenses
(in thousands)
(unaudited)
| | | | | | |
|---|---|---|---|---|---|
| | Three Months Ended March 31, | ||||
| | 2024 | | 2023 | ||
| GAAP operating expenses | $ | 41,982 | | $ | 52,775 |
| Adjustments: | | | | | |
| Stock-based compensation | | 7,475 | | | 6,035 |
| Litigation settlements | | — | | | 8,500 |
| Total adjustments | $ | 7,475 | | $ | 14,535 |
| Adjusted operating expenses | $ | 34,507 | | $ | 38,240 |
Collegium Pharmaceutical, Inc.
Reconciliation of GAAP Net Income (Loss) to Adjusted Net Income and Adjusted Earnings Per Share
(in thousands, except share and per share amounts)
(unaudited)
| | | | | | |
|---|---|---|---|---|---|
| | Three Months Ended March 31, | ||||
| | 2024 | | 2023 | ||
| GAAP net income (loss) | $ | 27,713 | | $ | (17,426) |
| Adjustments: | | | | | |
| Non-cash interest expense | | 1,780 | | | 2,287 |
| Loss on extinguishment of debt | | — | | | 23,504 |
| Amortization | | 34,517 | | | 37,466 |
| Stock-based compensation | | 7,475 | | | 6,035 |
| Litigation settlements | | — | | | 8,500 |
| Recognition of step-up basis in inventory | | — | | | 10,170 |
| Income tax effect of above adjustments ^(1)^ | | (12,653) | | | (18,874) |
| Total adjustments | $ | 31,119 | | $ | 69,088 |
| Non-GAAP adjusted net income | $ | 58,832 | | $ | 51,662 |
| | | | | | |
| Adjusted weighted-average shares — diluted ^(2)^ | | 41,438,466 | | | 40,196,015 |
| Adjusted earnings per share ^(2)^ | $ | 1.45 | | $ | 1.32 |
| (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 March 31, 2024 and 2023 were 26.6% and 26.8%, respectively. As such, the non-GAAP effective tax rates for the three months ended March 31, 2024 and 2023 were 28.9% and 21.5%, 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 March 31, 2024 and 2023, adjusted weighted-average shares – diluted includes 7,509,104 and 4,646,372 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. |
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Exhibit 99.2
| Q1’24 Earnings<br>Report<br>May 9, 2024 | Nasdaq: COLL |
|---|---|
| Forward-Looking Statements<br>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,"<br>"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<br>related to our full-year 2024 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<br>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,<br>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<br>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<br>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<br>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<br>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<br>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<br>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<br>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<br>or otherwise, after the date of this presentation.<br>Non-GAAP Financial Measures<br>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<br>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<br>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.<br>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.<br>Adjusted EBITDA<br>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<br>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.<br>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:<br>• 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;<br>• 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<br>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;<br>• adjusted EBITDA does not reflect changes in, or cash requirements for, working capital needs;<br>• adjusted EBITDA does not reflect the benefit from or provision for income taxes or the cash requirements to pay taxes;<br>• adjusted EBITDA does not reflect historical cash expenditures or future requirements for capital expenditures or contractual commitments;<br>• 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;<br>• 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<br>underlying business;<br>• 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;<br>• 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<br>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;<br>• 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<br>underlying business; and<br>• 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.<br>Adjusted Operating Expenses<br>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.<br>Adjusted Net Income and Adjusted Earnings Per Share<br>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.<br>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<br>the nature of the security.<br>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 presentation.<br>The Company has not provided a reconciliation of its full-year 2024 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<br>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<br>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<br>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.<br>2 | |
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| Business Update<br>Joe Ciaffoni, President & Chief Executive Officer | |
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| Healthier people.<br>Stronger communities.<br>Mission Driven<br>Building a leading, diversified specialty pharmaceutical company committed<br>to improving the lives of people living with serious medical conditions.<br>Doing Good As We Do Well<br>Partnering with organizations driving equitable access to STEM education in underserved communities<br>to support the next generation of scientists.<br>Committed To Environmental, Social And Governance (ESG) Initiatives<br>Operating with integrity, accountability and responsibility and investing in the long-term sustainability<br>of our business and the health of our broader communities.<br>4<br>Read our ESG report at collegiumpharma.com. | |
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| Track Record of Strong Top- and Bottom-Line Growth<br>5<br>1. This financial data was provided by Collegium in its Annual Report on Form 10-K filed with the SEC on February 23, 2023.<br>2. This financial data was provided by Collegium in its Annual Report on Form 10-K filed with the SEC on February 22, 2024.<br>3. This financial data was provided by Collegium in its press release filed with the SEC on May 9, 2024, and represents the mid-point of 2024 financial guidance ranges.<br>4. Represents a non-GAAP financial measure. Refer to “Non-GAAP Financial Measures” on slide 2.<br>G R O W L E V E R A G E E X PA N D<br>$277M1<br>$464M2<br>$567M2<br>$588M3<br>2021 2022 2023 2024E<br>Product Revenues, Net<br>$101M1<br>$122M2 $124M2 $123M3<br>2021 2022 2023 2024E<br>Adjusted Operating<br>Expenses4<br>$118M1<br>$266M2<br>$367M2<br>$388M3<br>2021 2022 2023 2024E<br>Adjusted EBITDA4 | |
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| Seamless Leadership Transition: Mike Heffernan as Interim CEO<br>6<br>• Founded Collegium in 2002 and served as President and CEO<br>for over 15 years<br>• Chairman of the Board of Collegium from 2018 to present<br>• Successful entrepreneur and biopharmaceutical leader with<br>over 25 years of experience building and leading development<br>stage and commercial companies<br>• Held leadership roles as CEO, advisor, investor and board<br>member in numerous biopharma, medical device and<br>healthcare services companies<br>Founder and Chairman of the Board of Collegium<br>Mike Heffernan to serve as Interim President and CEO during transition period until new CEO appointed; Board<br>of Directors has initiated the search for a successor | |
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| Business and Financial Highlights<br>Colleen Tupper, Executive Vice President & Chief Financial Officer | |
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| 1. This financial data was provided by Collegium in its Form 8-K and/or its Form 10-Q filed with the SEC on May 9, 2024.<br>2. Represents a non-GAAP financial measure. Refer to “Non-GAAP Financial Measures” on slide 2.<br>3. IQVIA NPA through March 2024.<br>4. Net debt/adjusted EBITDA is calculated based on financial data provided by Collegium in its Form 8-K and Form 10-Q filed with the SEC on May 9, 2024. Details regarding the Pharmakon term-loan debt amortization schedule provided by Collegium on form SC TO-C filed with the SEC on February 14, 2022.<br>Recent Business Highlights<br>8<br>Delivered strong Q1’24<br>financial performance1<br>• Product revenues, net: $144.9M, flat YoY<br>• Adjusted operating expenses: $34.5M, down (10)% YoY2<br>• Adjusted EBITDA: $92.4M, up 5% YoY2<br>Generated momentum<br>in our pain portfolio<br>• Grew Q1’24 Belbuca® prescriptions 4.2% YoY3<br>; generated record Belbuca revenue of<br>$50.7M, up 15% YoY<br>• Achieved Xtampza® ER GtN of 53.6% in Q1’24<br>• Bolstered value of Nucynta Franchise in 2025 and beyond through authorized generic<br>agreement with Hikma Pharmaceuticals<br>Strategically deployed<br>capital<br>• Called $26.4M aggregate principal amount of outstanding convertible senior notes due<br>2026 for redemption<br>• Repaid $45.8M of Pharmakon loan in Q1’24 and ended quarter with net debt/adjusted<br>EBITDA of ~0.8x4<br>• Board authorized $35.0M Accelerated Share Repurchase program | |
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| 2024 Priorities: Operational Execution<br>9<br>Financial<br>Commitments<br>• ACHIEVE record<br>revenue, adjusted EBITDA<br>and net income<br>• GENERATE record<br>free cash flow<br>Deploy Capital<br>• RAPIDLY pay down debt,<br>de-levering on a quarterly<br>basis<br>• OPPORTUNISTICALLY<br>leverage $150M share<br>repurchase program<br>D E L I V E R O N S T R A T E G I C A L L Y | |
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| 10<br>Q1’24 Financial Highlights1<br>1. This financial data was provided by Collegium in its Form 8-K and/or its Form 10-Q filed with the SEC on May 9, 2024.<br>2. Represents a non-GAAP financial measure. Refer to “Non-GAAP Financial Measures” on slide 2.<br>$144.8M $144.9M<br>Q1'23 Q1'24<br>Product Revenues, Net<br>$38.2M $34.5M<br>Q1'23 Q1'24<br>Adjusted Operating<br>Expenses2<br>$87.6M $92.4M<br>Q1'23 Q1'24<br>Adjusted EBITDA2<br>Flat<br>(10)%<br>+5% | |
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| 1. This financial data was provided by Collegium in its press release filed with the SEC on May 9, 2024.<br>2. This financial data is calculated based on data provided by Collegium in its press release filed with the SEC on February 22, 2024, and represents the percent change of<br>the mid-point of 2024 financial guidance ranges compared to 2023 results.<br>3. Represents a non-GAAP financial measure. Refer to “Non-GAAP Financial Measures” on slide 2.<br>Reaffirming 2024 Financial Guidance1<br>$580–595M<br>Up 3.7% YoY 2<br>P r o d u c t R e v e n u e s , N e t<br>$120–125M<br>Down (0.9)% YoY 2<br>A d j u s t e d O p e r a t i n g E x p e n s e s 3<br>(Excluding Stock-Based Compensation)<br>$380–395M<br>Up 5.6% YoY 2<br>11<br>A d j u s t e d E B I T D A 3<br>(Excluding Stock-Based Compensation) | |
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| 1. Adjusted EBITDA is a non-GAAP financial measure. Refer to “Non-GAAP Financial Measures” on slide 2. Net debt/adjusted EBITDA is calculated based on financial data provided by Collegium in<br>its Form 8-K and Form 10-Q filed with the SEC on May 9, 2024. 2024 net debt/adjusted EBITDA is calculated based on Collegium’s forecast of net debt at year-end 2024, compared to the mid-point of the 2024 guidance ranges provided by Collegium in its press release filed with the SEC on May 9, 2024. This financial data assumes no additional debt is incurred.<br>2. Details regarding the Pharmakon term-loan debt amortization schedule were provided by Collegium on form SC TO-C filed with the SEC on February 14, 2022.<br>3. This financial data is calculated from data provided by Collegium in its Annual Report on Form 10-K filed with the SEC on February 22, 2024.<br>Disciplined Capital Deployment<br>12<br>Rapidly Pay Down Debt<br>• Ended Q1’24 with net debt/adjusted EBITDA of ~0.8x; expect de minimis by year-end 20241,2<br>• Repaid $283.3M of Pharmakon loan to date ($650M issued 3/22/2022); will repay additional $137.5M in 20242<br>; Pharmakon<br>loan expected to be paid in full in Q1’262<br>• Called $26.4M principal amount of outstanding 2.625% convertible senior notes due 2026 for redemption; strengthens<br>balance sheet by reducing debt, positively impacts full-year diluted EPS, and potentially reduces technical short positions<br>Leverage Share Repurchase Program<br>• To date, returned $137M to shareholders by repurchasing 6.3M shares at average price of $21.653<br>• Board authorized $150M share repurchase program through Q2’25<br>• $35M Accelerated Share Repurchase program authorization announced today | |
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| 2021 2022 2023 2024 YTD<br>ASR program Open market share repurchases<br>13<br>Opportunistic Share Repurchases1<br>1. This financial data is calculated from data provided by Collegium in its Annual Reports on Form 10-K filed with the SEC on February 22, 2024.<br>$43M<br>$19M<br>$75M<br>$25M<br>ASR<br>$50M<br>ASR<br>$25M<br>ASR<br>Repurchased 6.3M shares<br>at average price of $21.65<br>Board Authorized $150M Share Repurchase Program Through Q2’25<br>Repurchased at<br>average price of<br>$27.09<br>Average Repurchase Price<br>Returned $137M of Capital to Shareholders from 2021 to 2023<br>2021 - $19.93<br>2022 - $17.57<br>2023 - $24.29<br>$35M<br>$35M ASR<br>authorization<br>announced today | |
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| Commercial Update<br>Scott Dreyer, Executive Vice President & Chief Commercial Officer | |
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| 15<br>Q1’24 Commercial Update<br>10,100<br>Unique prescribers3<br>16,300<br>Unique prescribers3<br>10,600<br>Unique prescribers3<br>Collegium Portfolio has Over 50% Branded ER Market Share<br>and Large Prescriber Bases1,2<br>1. IQVIA NPA through March 2024.<br>2. Quarter-ending product share (Belbuca, Xtampza ER, and Nucynta® ER).<br>3. IQVIA Xponent through March 2024; approximate quarterly prescriber counts. | |
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| #1 highest rated branded ER opioid in<br>terms of product differentiation and<br>favorability2<br>74% of surveyed target HCPs plan to<br>increase prescribing2<br>S T R O N G B R A N D<br>F U N D A M E N TA L S<br>16<br>Well Positioned to Grow Belbuca Prescriptions and Revenue in 2024<br>1. IQVIA NPA through March 2024.<br>2. ATU (Awareness, Trial, & Usage) Market Research Study, fielded Q4 2022.<br>Increasing momentum for Belbuca in Q1’24<br>G R O W I N G B E L B U C A<br>P R E S C R I P T I O N S<br>+4.2%<br>YoY growth in Belbuca prescriptions in<br>Q1’241<br>Reinforce clinical differentiation<br>Pull through strong commercial access<br>position<br>Expand Medicare Part D coverage<br>C O M M E R C I A L<br>P R I O R I T I E S | |
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| #1 highest rated ER oxycodone in<br>terms of product differentiation and<br>favorability1<br>48% of surveyed target HCPs plan to<br>increase prescribing, while 60% plan to<br>decrease prescribing of OxyContin1<br>Strong market access coverage across<br>all payor types, commercial and<br>Medicare Part D<br>S T R O N G B R A N D<br>F U N D A M E N TA L S & M A R K E T<br>A C C E S S P O S I T I O N<br>17<br>Xtampza ER Poised to Grow Revenue in 2024<br>S U C C E S S F U L LY<br>M A N A G I N G G T N<br>53.6%<br>GtN in Q1’24<br>Reinforce clinical differentiation<br>Pull through strong commercial and<br>Medicare Part D access positions<br>Expand coverage while managing GtN<br>below 65%<br>C O M M E R C I A L<br>P R I O R I T I E S<br>1. ATU (Awareness, Trial, & Usage) Market Research Study, fielded Q4 2022.<br>Xtampza ER GtN expected to be<br>56%–58% in 2024 | |
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| Closing Remarks<br>Joe Ciaffoni, President & Chief Executive Officer | |
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| 19<br>Creating Long-Term Value Through Operational Execution<br>DELIVER ON<br>Financial commitments of top- and bottom-line growth:<br>• Achieve record revenue, adjusted EBITDA and net income<br>• Generate record free cash flow<br>STRATEGICALLY<br>Deploy capital in a disciplined manner:<br>• Rapidly pay down $183.3M in debt in 2024<br>• Return capital to shareholders by leveraging $150M share<br>repurchase program<br>Creating value for<br>shareholders by:<br>✓ Growing revenue<br>✓ Increasing profitability<br>✓ Generating<br>strong cash flows<br>✓ Strategically deploying<br>capital | |
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| Q&A | |
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| Non-GAAP Reconciliations | |
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| Collegium Pharmaceutical, Inc.<br>Reconciliation of GAAP Net Income (Loss) to Adjusted EBITDA<br>(in thousands)<br>(unaudited)<br>22<br>GAAP net income (loss) $ 27,713 $ (17,426)<br>Adjustments:<br>Interest expense 17,339 21,427<br>Interest income (4,487) (2,747)<br>Loss on extinguishment of debt — 23,504<br>Provision for (benefit from) income taxes 8,909 (131)<br>Depreciation 917 817<br>Amortization 34,517 37,466<br>Stock-based compensation 7,475 6,035<br>Litigation settlements — 8,500<br>Recognition of step-up basis in inventory — 10,170<br>Total adjustments $ 64,670 $ 105,041<br>Adjusted EBITDA $ 92,383 $ 87,615<br>2024<br>Three Months Ended March 31,<br>2023 | |
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| Collegium Pharmaceutical, Inc.<br>Reconciliation of GAAP Operating Expenses to Adjusted Operating Expenses<br>(in thousands)<br>(unaudited)<br>23<br>GAAP operating expenses $ 41,982 $ 52,775<br>Adjustments:<br>Stock-based compensation 7,475 6,035<br>Litigation settlements — 8,500<br>Total adjustments $ 7,475 $ 14,535<br>Adjusted operating expenses $ 34,507 $ 38,240<br>2024 2023<br>Three Months Ended March 31, | |
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| Collegium Pharmaceutical, Inc.<br>Reconciliation of GAAP Net Income (Loss) to Adjusted Net Income and Adjusted Earnings Per Share<br>(in thousands, except share and per share amounts)<br>(unaudited)<br>(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<br>months ended March 31, 2024 and 2023 were 26.6% and 26.8%, respectively. As such, the non-GAAP effective tax rates for the three months ended March 31, 2024 and 2023 were 28.9% and 21.5%, respectively.<br>(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<br>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<br>March 31, 2024 and 2023, adjusted weighted-average shares – diluted includes 7,509,104 and 4,646,372 shares, respectively, attributable to our convertible notes. In addition, adjusted earnings per share<br>includes other potentially dilutive securities to the extent that they are not antidilutive. 24<br>GAAP net income (loss) $ 27,713 $ (17,426)<br>Adjustments:<br>Non-cash interest expense 1,780 2,287<br>Loss on extinguishment of debt — 23,504<br>Amortization 34,517 37,466<br>Stock-based compensation 7,475 6,035<br>Litigation settlements — 8,500<br>Recognition of step-up basis in inventory — 10,170<br>Income tax effect of above adjustments (1)<br> (12,653) (18,874)<br>Total adjustments $ 31,119 $ 69,088<br>Non-GAAP adjusted net income $ 58,832 $ 51,662<br>Adjusted weighted-average shares — diluted (2)<br> 41,438,466 40,196,015<br>Adjusted earnings per share (2) $ 1.45 $ 1.32<br>Three Months Ended March 31,<br>2024 2023 | |
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