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Collegium Reports Fourth Quarter and Full-Year 2022 Financial Results

February 23, 2023 4:01 PM

– 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., Feb. 23, 2023 (GLOBE NEWSWIRE) -- 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

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

Financial Results for Year Ended December 31, 2022

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.

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 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 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[email protected]

Media Contact:Marissa SamuelsVice President, Corporate Communications[email protected]

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 EndedDecember 31, Years EndedDecember 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 EndedDecember 31, Years EndedDecember 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 EndedDecember 31, Years EndedDecember 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 EndedDecember 31, Years EndedDecember 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.

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Source: Collegium Pharmaceutical, Inc.

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