UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Item 2.02 Results of Operations and Financial Condition.
On February 23, 2023, Collegium Pharmaceutical, Inc. issued a press release announcing its financial results for the quarterly period and fiscal year ended December 31, 2022. 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 February 23, 2023, 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 23, 2023
Exhibit 99.1
Collegium Reports Fourth Quarter and Full-Year 2022 Financial Results
– Generated Record Quarterly and Full-Year Net Revenue of $129.6 and $463.9 Million –
– Ended 2022 with Cash Balance of $173.7 Million –
– Reaffirmed 2023 Financial Guidance –
– Conference Call Scheduled for Today at 4:30 p.m. ET –
STOUGHTON, Mass., February 23, 2023 – 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 and full-year ended December 31, 2022 and provided a corporate update.
“2022 was a pivotal year for Collegium Pharmaceutical. We acquired and seamlessly integrated BDSI, recognizing approximately $85 million in annual run-rate synergies; renegotiated Xtampza ER contracts, significantly reducing gross-to-net while maintaining broad access; and resolved all 27 opioid industry-related lawsuits brought against the Company,” said Joe Ciaffoni, President, and Chief Executive Officer of Collegium. “We expect 2023 to be a banner year highlighted by an acceleration of top- and bottom- line growth as we capitalize on lower Xtampza ER® gross-to-net and grow Xtampza ER and Belbuca® prescriptions on a full-year basis. We are committed to executing on our strategic priorities, including deploying capital in a disciplined manner, to create long-term value for shareholders.”
“Our fourth quarter results demonstrate Collegium’s financial strength as we delivered record net revenue, record adjusted EBITDA and robust operating cash flows,” said Colleen Tupper, Chief Financial Officer of Collegium. “We returned $19.1 million of capital to shareholders in 2022 and remain committed to strategically deploying capital with business development as our top priority, followed by rapid debt paydown and returning capital to shareholders through our $100 million share repurchase program. Our 2023 financial guidance conveys our confidence that 2023 will be a banner year.”
Full Year 2022 and 2023 Business Highlights
| ● | Completed Xtampza ER contract renegotiations, maintaining broad access while significantly decreasing rebates; Xtampza ER gross-to-net is expected to be in the range of 61% to 63% in 2023. |
| ● | Acquired and seamlessly integrated BDSI and achieved annual run-rate synergies of approximately $85 million. |
| ● | Returned $19.1 million in capital to shareholders in 2022, including $7.6 million in the quarter ended December 31, 2022, under the share repurchase program authorized by Collegium’s Board of Directors in August 2021. |
| ● | Authorized a new share repurchase program in January 2023 to repurchase up to $100 million in common stock. |
| ● | Completed a $241.5 million convertible senior note offering due in 2029. Net proceeds from the notes were used to partially repurchase outstanding convertible senior notes due in 2026 and the remainder of the net proceeds are expected to be used for general corporate purposes, including implementation of Collegium’s capital deployment strategy. |
| ● | Achieved dismissal, pursuant to a master settlement agreement, of all 27 opioid industry-related lawsuits brought against the Company by cities, counties, and other subdivisions in the United States, in March 2022. |
| ● | Issued inaugural environmental, social and governance (ESG) report in February 2023. |
Financial Guidance for 2023
The Company reaffirms its full-year 2023 financial guidance for Product Revenues, Net, Adjusted Operating Expenses and Adjusted EBITDA:
Product Revenues, Net | $565.0 to $580.0 million |
Adjusted Operating Expenses (Excluding Stock-Based Compensation) | $135.0 to $145.0 million |
Adjusted EBITDA (Excluding Stock-Based Compensation) | $355.0 to $370.0 million |
Financial Results for Quarter Ended December 31, 2022
| ● | Product revenues, net were $129.6 million for the quarter ended December 31, 2022 (the “2022 Quarter”), compared to $27.4 million for the quarter ended December 31, 2021 (the “2021 Quarter”). |
| ● | GAAP operating expenses were $38.0 million for the 2022 Quarter, compared to $32.8 million for the 2021 Quarter. Adjusted operating expenses, which exclude stock-based compensation expense of $5.7 million and acquisition related expenses of $0.1 million, were $32.3 million for the 2022 Quarter, compared to $20.4 million for the 2021 Quarter, which excluded stock-based compensation expense of $4.9 million, restructuring expenses of $4.6 million, and litigation settlements of $2.9 million. |
| ● | GAAP net loss for the 2022 Quarter was $(7.2) million, with $(0.21) GAAP loss per share (basic and diluted), compared to GAAP net loss for the 2021 Quarter of $(25.0) million, with $(0.73) GAAP loss per share (basic and diluted). Non-GAAP adjusted net income for the 2022 Quarter was $42.2 million, with $1.09 adjusted earnings per share, compared to non-GAAP adjusted net loss for the 2021 Quarter of $(2.5) million, with $(0.07) adjusted loss per share. |
| ● | Adjusted EBITDA for the 2022 Quarter was $76.4 million, compared to $(4.5) million for the 2021 Quarter. |
| ● | The Company exited the 2022 Quarter with a cash balance of $173.7 million, up from $134.1 million as of September 30, 2022. |
Financial Results for Year Ended December 31, 2022
| ● | Product revenues, net were $463.9 million for the year ended December 31, 2022 (“FY 2022”), compared to $276.9 million for the year ended December 31, 2021 (“FY 2021”). |
| ● | GAAP operating expenses were $176.2 million for FY 2022, compared to $133.0 million for FY 2021. Adjusted operating expenses, which exclude stock-based compensation of $22.9 million and acquisition related expenses of $31.3 million, were $122.0 million for FY 2022, compared to $101.2 million for FY 2021, which excluded stock-based compensation expense of $24.3 million, restructuring expenses of $4.6 million, and litigation settlements of $2.9 million. |
| ● | GAAP net loss for FY 2022 was $(25.0) million, with $(0.74) GAAP loss per share (basic and diluted), compared to GAAP net income for FY 2021 of $71.5 million, with $2.05 GAAP earnings per share (basic) and $1.86 GAAP earnings per share (diluted). Non-GAAP adjusted net income for FY 2022 was $152.7 million, with $3.96 adjusted earnings per share, compared to non-GAAP adjusted net income for FY 2021 of $102.2 million, with $2.58 adjusted earnings per share. |
| ● | Adjusted EBITDA for FY 2022 was $266.0 million, compared to $118.3 million for FY 2021. |
Conference Call Information
The Company will host a conference call and live audio webcast on Thursday, February 23, 2023, at 4:30 p.m. Eastern Time. To access the conference call, please dial (877) 407-8037 (U.S.) or (201) 689-8037 (International) and reference the “Collegium Q4 2022 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.
To supplement our financial results presented on a GAAP basis, we have included information about certain non-GAAP financial measures. We use these non-GAAP financial measures to understand, manage and evaluate our business as we believe they provide additional information on the performance of our business. We believe that the presentation of these non-GAAP financial measures, taken in conjunction with our results under GAAP, provide analysts, investors, lenders and other third parties insight into our view and assessment of our ongoing operating performance. In addition, we believe that the presentation of these non-GAAP financial measures, when viewed with our results under GAAP and the accompanying reconciliations, provide supplementary information that may be useful to analysts, investors, lenders, and other third parties in assessing our performance and results from period to period. We report these non-GAAP financial measures to portray the results of our operations prior to considering certain income statement elements. These non-GAAP financial measures should be considered in addition to, and not as a substitute for, or superior to, net income or other financial measures calculated in accordance with GAAP.
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 (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 (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 (a) 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 (b) 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; |
| ● | adjusted EBITDA does not reflect the benefit from or provision for income taxes or the cash requirements to pay taxes; |
| ● | adjusted EBITDA does not reflect historical cash expenditures or future requirements for capital expenditures or contractual commitments; |
| ● | we exclude impairment expenses from adjusted EBITDA and, although these are non-cash expenses, the asset 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; and |
| ● | 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. |
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 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 2023 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 2023 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: risks related to the ability to realize the anticipated benefits of our acquisitions at all or within the expected time period; unknown liabilities; risks related to future opportunities and plans for our products, including uncertainty of the expected financial performance of such products; the impact of the COVID-19 pandemic on our ability to conduct our business, reach our customers, and supply the market with our 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 obtain and maintain regulatory approval of our products and any product candidates, and any related restrictions, limitations, and/or warnings in the label of an approved product; the size of the markets for our products and product candidates, 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 and product candidates; 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)
| | December 31, | | December 31, | ||
|
| 2022 | | 2021 | ||
Cash and cash equivalents | | $ | 173,688 | | $ | 186,426 |
Accounts receivable, net | |
| 183,119 | | | 105,844 |
Inventory | |
| 46,501 | | | 17,394 |
Prepaid expenses and other current assets | |
| 16,681 | | | 5,879 |
Property and equipment, net | | | 19,521 | | | 19,491 |
Operating lease assets | |
| 6,861 | | | 7,644 |
Intangible assets, net | |
| 567,468 | | | 268,723 |
Restricted cash | |
| 2,547 | | | 2,547 |
Deferred tax assets | | | 23,950 | | | 78,042 |
Other noncurrent assets | |
| 100 | | | 87 |
Goodwill | | | 133,695 | | | — |
Total assets | | $ | 1,174,131 | | $ | 692,077 |
| | | | | | |
Accounts payable and accrued expenses | |
| 39,623 | | | 33,403 |
Accrued rebates, returns and discounts | |
| 230,491 | | | 196,996 |
Term notes payable | |
| 560,078 | | | 110,019 |
Convertible senior notes | | | 140,873 | | | 139,966 |
Operating lease liabilities | |
| 8,224 | | | 8,765 |
Shareholders’ equity | |
| 194,842 | | | 202,928 |
Total liabilities and stockholders’ equity | | $ | 1,174,131 | | $ | 692,077 |
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, | ||||||||
| 2022 | | 2021 | | 2022 | | 2021 | ||||
Product revenues, net | $ | 129,620 | | $ | 27,362 | | $ | 463,933 | | $ | 276,868 |
Cost of product revenues | | | | | | | | | | | |
Cost of product revenues (excluding intangible asset amortization) | | 37,552 | | | 11,900 | | | 118,190 | | | 59,070 |
Intangible asset amortization and impairment | | 42,279 | | | 16,795 | | | 136,255 | | | 67,181 |
Total cost of products revenues |
| 79,831 | |
| 28,695 | |
| 254,445 | |
| 126,251 |
Gross profit | | 49,789 | | | (1,333) | | | 209,488 | | | 150,617 |
Operating expenses | | | | | | | | | | | |
Research and development | | — | | | 1,609 | | | 3,983 | | | 9,451 |
Selling, general and administrative |
| 38,032 | |
| 26,602 | |
| 172,186 | |
| 118,960 |
Restructuring | | — | | | 4,578 | | | — | | | 4,578 |
Total operating expenses |
| 38,032 | |
| 32,789 | |
| 176,169 | |
| 132,989 |
Income (loss) from operations |
| 11,757 | |
| (34,122) | |
| 33,319 | |
| 17,628 |
Interest expense |
| (20,575) | |
| (4,757) | |
| (63,213) | |
| (21,014) |
Interest income | | 1,027 | | | 3 | | | 1,047 | | | 12 |
Loss before income taxes | | (7,791) | | | (38,876) | | | (28,847) | | | (3,374) |
Benefit from income taxes | | (592) | | | (13,842) | | | (3,845) | | | (74,891) |
Net (loss) income | $ | (7,199) | | $ | (25,034) | | $ | (25,002) | | $ | 71,517 |
| | | | | | | | | | | |
(Loss) earnings per share — basic | $ | (0.21) | | $ | (0.73) | | $ | (0.74) | | $ | 2.05 |
Weighted-average shares — basic | | 33,582,202 | | | 34,123,309 | | | 33,829,495 | | | 34,936,817 |
| | | | | | | | | | | |
(Loss) earnings per share — diluted | $ | (0.21) | | $ | (0.73) | | $ | (0.74) | | $ | 1.86 |
Weighted-average shares — diluted | | 33,582,202 | | | 34,123,309 | | | 33,829,495 | | | 41,045,805 |
Collegium Pharmaceutical, Inc.
Reconciliation of GAAP Net Income to Adjusted EBITDA
(in thousands)
(unaudited)
| | | | | | | | | | | |
| Three Months Ended December 31, | | Years Ended December 31, | ||||||||
| 2022 | | 2021 | | 2022 | | 2021 | ||||
GAAP net (loss) income | $ | (7,199) | | $ | (25,034) | | $ | (25,002) | | $ | 71,517 |
Adjustments: | | | | | | | | | | | |
Interest expense | | 20,575 | | | 4,757 | | | 63,213 | | | 21,014 |
Interest income | | (1,027) | | | (3) | | | (1,047) | | | (12) |
Benefit from income taxes | | (592) | | | (13,842) | | | (3,845) | | | (74,891) |
Depreciation | | 825 | | | 424 | | | 2,684 | | | 1,736 |
Amortization | | 37,493 | | | 16,795 | | | 131,469 | | | 67,181 |
Impairment expense | | 4,786 | | | — | | | 4,786 | | | — |
Stock-based compensation expense | | 5,670 | | | 4,912 | | | 22,874 | | | 24,255 |
Restructuring | | — | | | 4,578 | | | — | | | 4,578 |
Litigation Settlements | | — | | | 2,935 | | | — | | | 2,935 |
Acquisition related expenses | | 88 | | | — | | | 31,297 | | | — |
Recognition of step-up basis in inventory | | 15,824 | | | — | | | 39,584 | | | — |
Total adjustments | $ | 83,642 | | $ | 20,556 | | $ | 291,015 | | $ | 46,796 |
Adjusted EBITDA | $ | 76,443 | | $ | (4,478) | | $ | 266,013 | | $ | 118,313 |
Collegium Pharmaceutical, Inc.
Reconciliation of GAAP Operating Expenses to Adjusted Operating Expenses
(in thousands)
(unaudited)
| Three Months Ended December 31, | | Years Ended December 31, | ||||||||
| | 2022 | | | 2021 |
| | 2022 | | | 2021 |
GAAP operating expenses | $ | 38,032 | | $ | 32,789 | | $ | 176,169 | | $ | 132,989 |
Adjustments: | | | | | | | | | | | |
Stock-based compensation | | 5,670 | | | 4,912 | | | 22,874 | | | 24,255 |
Restructuring | | — | | | 4,578 | | | — | | | 4,578 |
Litigation Settlements | | — | | | 2,935 | | | — | | | 2,935 |
Acquisition related expenses | | 88 | | | — | | | 31,297 | | | — |
Total adjustments | $ | 5,758 | | $ | 12,425 | | $ | 54,171 | | $ | 31,768 |
Adjusted operating expenses | $ | 32,274 | | $ | 20,364 | | $ | 121,998 | | $ | 101,221 |
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, | ||||||||
| | 2022 | | | 2021 | | | 2022 | | | 2021 |
GAAP net (loss) income | $ | (7,199) | | $ | (25,034) | | $ | (25,002) | | $ | 71,517 |
Adjustments: | | | | | | | | | | | |
Non-cash interest expense | | 2,383 | | | 779 | | | 8,285 | | | 3,406 |
Amortization | | 37,493 | | | 16,795 | | | 131,469 | | | 67,181 |
Impairment expense | | 4,786 | | | — | | | 4,786 | | | — |
Stock-based compensation expense | | 5,670 | | | 4,912 | | | 22,874 | | | 24,255 |
Restructuring | | — | | | 4,578 | | | — | | | 4,578 |
Litigation settlements | | — | | | 2,935 | | | — | | | 2,935 |
Acquisition related expenses | | 88 | | | — | | | 31,297 | | | — |
Recognition of step-up basis in inventory | | 15,824 | | | — | | | 39,584 | | | — |
Discrete deferred tax benefit from valuation allowance release | | — | | | — | | | — | | | (62,649) |
Income tax effect of above adjustments (1) | | (16,855) | | | (7,445) | | | (60,553) | | | (9,071) |
Total adjustments | $ | 49,389 | | $ | 22,554 | | $ | 177,742 | | $ | 30,635 |
Non-GAAP adjusted net income (loss) | $ | 42,190 | | $ | (2,480) | | $ | 152,740 | | $ | 102,152 |
| | | | | | | | | | | |
Adjusted weighted-average shares — diluted (2) | | 39,644,115 | | | 34,123,309 | | | 39,531,814 | | | 41,045,805 |
Adjusted earnings (loss) per share (2) | $ | 1.09 | | $ | (0.07) | | $ | 3.96 | | $ | 2.58 |
| (1) | The income tax effect of the adjustments was calculated by applying our blended federal and state statutory rate of 26% to the items that have a tax effect. As such, the non-GAAP effective tax rates for the three months ended December 31, 2022 and 2021 were 25.4% and 24.8%, respectively, and the non-GAAP effective tax rates for the years ended December 31, 2022 and 2021 were 25.4% and 22.8%, respectively. |
| (2) | Adjusted weighted-average shares - diluted were calculated using the “if-converted” method for the convertibles notes in accordance with ASC 260, Earnings per Share. As such, for periods where non-GAAP adjusted income (loss) was in an income position, adjusted earnings per share includes 4,925,134 shares related to the assumed conversion of the convertible notes and the associated cash interest expense added-back to non-GAAP adjusted net income, as well as other potentially dilutive securities to the extent that they are not antidilutive. |
| Q4 and FY 2022 Earnings Report February 23, 2023 Nasdaq: COLL |
| 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 2023 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: risks related to the ability to realize the anticipated benefits of our acquisitions at all or within the expected time period; unknown liabilities; risks related to future opportunities and plans for our products, including uncertainty of the expected financial performance of such products; the impact of the COVID-19 pandemic on our ability to conduct our business, reach our customers, and supply the market with our 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 obtain and maintain regulatory approval of our products and any product candidates, and any related restrictions, limitations, and/or warnings in the label of an approved product; the size of the markets for our products and product candidates, 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 and product candidates; 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. 2 |
| 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 use these non-GAAP financial measures to understand, manage and evaluate our business as we believe they provide additional information on the performance of our business. We believe that the presentation of these non-GAAP financial measures, taken in conjunction with our results under GAAP, provide analysts, investors, lenders and other third parties insight into our view and assessment of our ongoing operating performance. In addition, we believe that the presentation of these non-GAAP financial measures, when viewed with our results under GAAP and the accompanying reconciliations, provide supplementary information that may be useful to analysts, investors, lenders, and other third parties in assessing our performance and results from period to period. We report these non-GAAP financial measures to portray the results of our operations prior to considering certain income statement elements. These non-GAAP financial measures should be considered in addition to, and not as a substitute for, or superior to, net income or other financial measures calculated in accordance with GAAP. 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 (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 (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 (a) 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 (b) 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; • adjusted EBITDA does not reflect the benefit from or provision for income taxes or the cash requirements to pay taxes; • adjusted EBITDA does not reflect historical cash expenditures or future requirements for capital expenditures or contractual commitments; • we exclude impairment expenses from adjusted EBITDA and, although these are non-cash expenses, the asset 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; and • 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. 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 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 presentation. The Company has not provided a reconciliation of its full-year 2023 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. |
| Mission Driven Building a leading, diversified specialty pharmaceutical company committed to improving the lives of people living with serious medical conditions. 4 Committed to sustainability, social impact and ethical governance Environmental: Be a responsible steward of the environment Social: Do the right thing for our employees, patients, providers, customers and communities Governance: Act in the best interests of our stakeholders Inaugural ESG Report for 2022 Now Published: Read Here |
| Collegium’s Operational Excellence in 2022 Delivered Strong Financial Performance1 Record product revenues, net: $463.9M, up 68% YoY Adjusted operating expenses: $122.0, up 21% YoY2 Record adjusted EBITDA: $266.0, up 125% YoY2 Deployed Capital Acquired BDSI, expanding leadership position in responsible pain management and building durable revenue Rapidly paid down debt, with year-end 2022 net debt/adjusted EBITDA of 2.0x2,3 Opportunistically returned $19.1M of capital to shareholders through share repurchases in 20221 Achieved Operational Objectives Achieved annual run-rate BDSI synergies of ~$85 million Renegotiated Xtampza® ER contracts to improve GTNs to <65% in 2023 Achieved Phases 1 and 2 of Three Phase Action Agenda Resolved all 27 opioid industry-related lawsuits 5 1. This financial data was provided by Collegium in its press release filed with the SEC on February 23, 2023. 2. Adjusted EBITDA and adjusted operating expenses are non-GAAP financial measures. See Non-GAAP Financial Measures on Slide 3. 3. The net debt/adjusted EBITDA ratio is calculated based on financial data provided by Collegium in its Annual Report on Form 10-K filed with the SEC on February 23, 2023. 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. |
| $118M $266M $363M 2021 2022 2023E Adjusted EBITDA3 $277M $464M $573M 2021 2022 2023E Product Revenues, Net 6 2023 To Be A Banner Year 2 2 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 press release filed with the SEC on February 23, 2023, and represents the mid-point of 2023 financial guidance ranges. 3. Adjusted operating expenses and adjusted EBITDA are non-GAAP financial measures. See Non-GAAP Financial Measures on Slide 3. +44% CAGR +75% CAGR $101M $122M $140M 2021 2022 2023E Adjusted Operating Expenses3 ACCELERATION DISCIPLINE LEVERAGE +18% CAGR 2 1 1 1 |
| Action Agenda Phase 3: Accelerate Top- and Bottom-Line Growth Phase 1 (03/22/22–06/30/22) Seamless Integration 1. Executed with no disruptions to core operations 2. Achieved day one field force readiness 3. Realized majority of targeted run rate synergies Phase 2 (07/01/22–12/31/22) Generate Momentum 1. Grew Belbuca® and Xtampza ER 2. Completed Xtampza ER contract renegotiations 3. Achieved remainder of target synergies 4. Synthesized Elyxyb™ launch learnings Phase 3 (2023) Accelerate Top- and Bottom-Line Growth 1. Propelled by Xtampza ER gross-to-net of 61% to 63% starting in January 2023 2. Driven by Belbuca and Xtampza ER TRx growth 3. Bolstered by fully synergized cost structure COMPLETED 2023 7 |
| Strategy for a Banner 2023 • Generate strong cash flow from pain portfolio through commercial execution and leveraging cost structure • Grow Belbuca and Xtampza ER prescriptions • Maximize Nucynta Franchise and Symproic® • Conduct business development focused on commercial-stage, durable assets • Rapidly pay down debt • Opportunistically return capital to shareholders Maximize Portfolio Deploy Capital 8 |
| Financial Highlights Colleen Tupper Executive Vice President & Chief Financial Officer |
| 10 FY2022 Financial Highlights FY2022 Product Revenue, Net $463.9 Million +68% Over FY2021 Record Revenue1 FY2022 Adjusted EBITDA $266.0 Million +125% Over FY2021 Record Adjusted EBITDA1,2 Net Debt/Adjusted EBITDA Ratio 2.0x At 2022 Year-End Rapid Delevering1,3 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. Adjusted EBITDA is a non-GAAP financial measure. See Non-GAAP Financial Measures on Slide 3. 3. 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. |
| 1. This financial data was provided by Collegium in its press release filed with the SEC on February 23, 2023. 2. Adjusted operating expenses is a non-GAAP financial measure. See Non-GAAP Financial Measures on Slide 3. 3. Adjusted EBITDA is a non-GAAP financial measure. See Non-GAAP Financial Measures on Slide 3. 11 2023 Financial Guidance1 Product Revenues, Net Adjusted Operating Expenses2 (Excluding Stock-Based Compensation) Adjusted EBITDA3 (Excluding Stock-Based Compensation) $565 – 580M $135 – 145M $355 – 370M |
| 1. Adjusted EBITDA is a non-GAAP financial measure. See Non-GAAP Financial Measures on Slide 3. 2023 net debt/adjusted EBITDA is calculated based on Collegium’s forecast of net debt at year-end 2023, compared to the mid-point of the 2023 guidance ranges provided by Collegium in its press release filed with the SEC on February 23, 2023. This financial data assumes no additional debt is incurred. 2. 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. 3. This financial data was provided by Collegium in its Annual Report on Form 10-K filed with the SEC on February 23, 2023. 12 Capital Deployment Priorities Focused on Long-Term Value Creation • Targeting commercial-stage assets to diversify specialty pharmaceutical portfolio • Peak sales potential of >$150M • Differentiated product with a leading market position • Durable with exclusivity into 2030s Focused Business Development • Net debt/adjusted EBITDA of 2.0x at year-end 2022; expect <1.5x by year-end 20231,2 • Tracking to repay >$160M of Pharmakon loan ($650M issued 3/22/2022) in 20232 Rapidly Paydown Debt • Strong track record of opportunistic share repurchases • Returned $42.9M and $19.1M to shareholders in 2021 and 2022, respectively3 • 2023 share repurchase plan authorizes up to $100M Return Capital to Shareholders |
| Commercial Update Scott Dreyer Executive Vice President & Chief Commercial Officer |
| ~9K ~19K ~13K 14 Q4FY22 Commercial Update Strong and Growing Market Position 50% Branded ER Market Share1,2 +2% Over Q4FY21 Sources: 1. IQVIA NPA through December 2022. 2. Quarter-ending product share (Belbuca, Xtampza ER, and Nucynta® ER). 3. IQVIA Xponent through December 2022; quarterly prescriber counts. Large Prescriber Base3 |
| 15 The Leader in Responsible Pain Management Source: ATU (Awareness, Trial, & Usage) Market Research Study, fielded Q4 2022 Collegium is rated #1 in responsible pain management by HCPs #1 highest rated branded ER opioid in terms of product differentiation and favorability 74% of surveyed target HCPs plan to increase prescribing #1 highest rated ER oxycodone in terms of product differentiation and favorability 48% of surveyed target HCPs plan to increase prescribing, while 60% plan to decrease prescribing of OxyContin® #2 highest rated branded ER opioid in terms of product differentiation (only after buprenorphine products) 34% of surveyed target HCPs plan to increase prescribing |
| 2023 Commercial Priorities 16 Grow Belbuca and Xtampza ER Win in Managed Care • Strengthen commercial execution with salesforce training and education • Reinforce clinical differentiation • Pull-through strong access positions • Expand access by achieving new payer wins for Belbuca and Xtampza ER • Renegotiate Xtampza ER contracts representing 30% of prescriptions |
| Healthier people. Stronger communities. Mission Driven Building a leading, diversified specialty pharmaceutical company committed to improving the lives of people living with serious medical conditions. Guided by Our Core Values Uphold Integrity Embrace Differences Encourage Expression Be Accountable I D E A We maintain uncompromising integrity in everything we say and do. We embrace differences as they make our ideas richer and serve our patients better. We encourage everyone to think big, push ourselves and make our voices heard. We are accountable to each other, our customers and our community. 17 |
| Q&A |
| Non-GAAP Reconciliations |
| Collegium Pharmaceutical, Inc. Reconciliation of GAAP Net Income to Adjusted EBITDA (in thousands) (unaudited) 20 GAAP net (loss) income $ (7,199) $ (25,034) $ (25,002) $ 71,517 Adjustments: Interest expense 20,575 4,757 63,213 21,014 Interest income (1,027) (3) (1,047) (12) Benefit from income taxes (592) (13,842) (3,845) (74,891) Depreciation 825 424 2,684 1,736 Amortization 37,493 16,795 131,469 67,181 Impairment expense 4,786 — 4,786 — Stock-based compensation expense 5,670 4,912 22,874 24,255 Restructuring — 4,578 — 4,578 Litigation settlements — 2,935 — 2,935 Acquisition related expenses 88 — 31,297 — Recognition of step-up basis in inventory 15,824 — 39,584 — Total adjustments $ 83,642 $ 20,556 $ 291,015 $ 46,796 Adjusted EBITDA $ 76,443 $ (4,478) $ 266,013 $ 118,313 Three Months Ended December 31, Years Ended December 31, 2022 2021 2022 2021 |
| Collegium Pharmaceutical, Inc. Reconciliation of GAAP Operating Expenses to Adjusted Operating Expenses (in thousands) (unaudited) 21 GAAP operating expenses $ 38,032 $ 32,789 $ 176,169 $ 132,989 Adjustments: Stock-based compensation 5,670 4,912 22,874 24,255 Restructuring — 4,578 — 4,578 Litigation settlements — 2,935 — 2,935 Acquisition related expenses 88 — 31,297 — Total adjustments $ 5,758 $ 12,425 $ 54,171 $ 31,768 Adjusted operating expenses $ 32,274 $ 20,364 $ 121,998 $ 101,221 Three Months Ended December 31, Years Ended December 31, 2022 2021 2022 2021 |
| 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) 1. The income tax effect of the adjustments was calculated by applying our blended federal and state statutory rate of 26% to the items that have a tax effect. As such, the non-GAAP effective tax rates for the three months ended December 31, 2022 and 2021 were 25.4% and 24.8%, respectively, and the non-GAAP effective tax rates for the years ended December 31, 2022 and 2021 were 25.4% and 22.8%, respectively. 2. Adjusted weighted-average shares - diluted were calculated using the “if-converted” method for the convertibles notes in accordance with ASC 260, Earnings per Share. As such, for periods where non-GAAP adjusted income (loss) was in an income position, adjusted earnings per share includes 4,925,134 shares related to the assumed conversion of the convertible notes and the associated cash interest expense added-back to non-GAAP adjusted net income, as well as other potentially dilutive securities to the extent that they are not antidilutive. 22 GAAP net (loss) income $ (7,199) $ (25,034) $ (25,002) $ 71,517 Adjustments: Non-cash interest expense 2,383 779 8,285 3,406 Amortization 37,493 16,795 131,469 67,181 Impairment expense 4,786 — 4,786 — Stock-based compensation expense 5,670 4,912 22,874 24,255 Restructuring — 4,578 — 4,578 Litigation settlements — 2,935 — 2,935 Acquisition related expenses 88 — 31,297 — Recognition of step-up basis in inventory 15,824 — 39,584 — Discrete deferred tax benefit from valuation allowance release — — — (62,649) Income tax effect of above adjustments (1) (16,855) (7,445) (60,553) (9,071) Total adjustments $ 49,389 $ 22,554 $ 177,742 $ 30,635 Non-GAAP adjusted net income (loss) $ 42,190 $ (2,480) $ 152,740 $ 102,152 Adjusted weighted-average shares — diluted (2) 39,644,115 34,123,309 39,531,814 41,045,805 Adjusted earnings (loss) per share (2) $ 1.09 $ (0.07) $ 3.96 $ 2.58 Three Months Ended December 31, Years Ended December 31, 2022 2021 2022 2021 |
