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):January 1, 2023
COLLEGIUM PHARMACEUTICAL, INC.
(Exact name of registrant as specified in itscharter)
| Virginia | 001-37372 | 03-0416362 |
|---|---|---|
| (state or other jurisdiction<br><br>of incorporation) | (CommissionFile Number) | (I.R.S. Employer<br><br>Identification No.) |
| 100 Technology Center Drive<br><br> <br>Suite 300<br><br> <br>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 sincelast report)
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | TradingSymbol(s) | Name of each exchange on which registered |
|---|---|---|
| Common stock, par value $0.001 per share | COLL | The NASDAQ Global Select Market |
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)) |
| --- | --- |
Indicated 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 7.01 | Regulation FD Disclosure. |
|---|
On January 4, 2023, Collegium Pharmaceutical, Inc. (the “Company”) issued a press release announcing full-year revenue, adjusted operating expense and adjusted EBITDA guidance for 2023. The Company also announced that the Board of Directors of the Company authorized a new share repurchase program for 2023 to repurchase up to $100 million of the Company’s shares of common stock, which program is described in more detail under Item 8.01 of this Current Report on Form 8-K. A copy of the press release is attached hereto as Exhibit 99.1 and is being furnished, not filed, under Item 7.01 of this Current Report on Form 8-K.
In addition, on January 4, 2023, the Company posted a corporate presentation to its website that representatives of the Company may use from time to time in presentations or discussions with investors, analysts or other parties. A copy of 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.
To the extent that the information in this Current Report on Form 8-K, including Exhibits 99.1 and 99.2 furnished herewith, are not descriptions of historical facts regarding the Company, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The Company 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 Current Report on Form 8-K, including Exhibits 99.1 and 99.2 furnished herewith, include, among others, statements related to the Company’s full-year 2023 financial guidance, including projected product revenue, adjusted operating expenses and adjusted EBITDA, current and future market opportunities for its products and the Company’s 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. Actual results may differ materially from management’s expectations and such forward-looking statements in this Current Report on Form 8-K, including Exhibits 99.1 and 99.2 furnished herewith, could be affected as a result of various important factors, including risks relating to, among others: risks related to the ability to realize the anticipated benefits of the Company’s acquisitions at all or within the expected time period; unknown liabilities; risks related to future opportunities and plans for the Company’s products, including uncertainty of the expected financial performance of such products; the impact of the COVID-19 pandemic on the Company’s ability to conduct its business, reach its customers, and supply the market with its products; its ability to commercialize and grow sales of its products; its ability to manage its relationships with licensors; the success of competing products that are or become available; the Company’s ability to obtain and maintain regulatory approval of its 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 the Company’s products and product candidates, and the Company’s ability to service those markets; the Company’s ability to obtain reimbursement and third-party payor contracts for its products; the rate and degree of market acceptance of the Company’s products and product candidates; the costs of commercialization activities, including marketing, sales and distribution; changing market conditions for the Company’s products; the outcome of any patent infringement or other litigation that may be brought by or against the Company; the outcome of any governmental investigation related to the Company’s business; the Company’s ability to secure adequate supplies of active pharmaceutical ingredient for each of its products and manufacture adequate supplies of commercially saleable inventory; the Company’s ability to obtain funding for its operations and business development; regulatory developments in the U.S.; the Company’s expectations regarding its ability to obtain and maintain sufficient intellectual property protection for its products; the Company’s ability to comply with stringent U.S. and foreign government regulation in the manufacture of pharmaceutical products, including U.S. Drug Enforcement Agency compliance; the Company’s customer concentration; and the accuracy of the Company’s estimates regarding expenses, revenue, capital requirements and need for additional financing. These and other risks are described under the heading "Risk Factors" in the Company’s Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Committee. Any forward-looking statements that the Company makes in this Current Report on Form 8-K, including Exhibits 99.1 and 99.2 furnished herewith, speak only as of the date of this Current Report on Form 8-K. The Company assumes no obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, after the date of this Current Report on Form 8-K.
| Item 8.01 | Other Information. |
|---|
On January 1, 2023, the Board of Directors of the Company authorized a new share repurchase program to repurchase up to $100 million of the Company’s shares of common stock through December 31, 2023. The timing and amount of any shares purchased on the open market will be determined based on the Company’s evaluation of the market conditions, share price and other factors. The Company plans to utilize existing cash on hand to fund the share repurchase program.
| Item 9.01 | Financial Statements and Exhibits. |
|---|---|
| (d) | Exhibits. |
| --- | --- |
| ExhibitNo. | Description |
| --- | --- |
| 99.1 | Press Release, dated January 4, 2023. |
| 99.2 | Corporate Presentation, dated January 4, 2023. |
| 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 |
| Name: Colleen Tupper | |
| Executive Vice President and Chief Financial Officer |
Dated: January 4, 2023
Exhibit****99.1
CollegiumProvides 2023 Financial Guidance
–Product Revenues, Net Expected in the Range of $565.0 Million to $580.0 Million –
–Adjusted Operating Expenses* Expected in the Range of $135.0 Million to $145.0 Million –
–Adjusted EBITDA* Expected in the Range of $355.0 Million to $370.0 Million –
–$100 Million Share Repurchase Program Authorized by the Board of Directors –
STOUGHTON,Mass., January 4, 2023 -- Collegium Pharmaceutical, Inc. (Nasdaq: COLL), a leading, diversified specialty pharmaceutical company, today announced its 2023 full-year financial guidance and provided a business update.
“2022 was a pivotal year for Collegium. We achieved the first two phases of our Three Phase Action Agenda, which included integrating BDSI, completing Xtampza^®^ ER contract renegotiations to ensure gross-to-net of less than 65%, and generating momentum across our differentiated and distinctly positioned pain portfolio,” said Joe Ciaffoni, President and Chief Executive Officer of Collegium. “With these accomplishments, 2023 is set to be a banner year. We are focused on executing Phase 3, Accelerate, building our leadership position in responsible pain management, and deploying capital to maximize shareholder value.”
“Driven by Xtampza ER and Belbuca^®^, we expect to immediately accelerate revenue growth making 2023 a banner year for Collegium. With our fully synergized cost structure, we expect significant bottom-line expansion, with adjusted EBITDA expected to grow at over four times the rate of adjusted operating expenses,” said Colleen Tupper, Chief Financial Officer of Collegium. “We are committed to deploying capital in a disciplined manner with business development as our highest priority. We plan to continue rapidly paying down debt and opportunistically returning capital to shareholders through our new $100 million share repurchase program.”
RecentBusiness Highlights
| ● | Collegium’s<br> board of directors authorized a new share repurchase program for 2023 to repurchase up to<br> $100 million in common stock |
|---|---|
| ● | Returned<br> $19.1 million in capital to shareholders in 2022 under the share repurchase program authorized<br> by Collegium’s board of directors in August 2021, including $4.0 million repurchased<br> since November 3, 2022 |
| --- | --- |
| ● | In<br> December 2022, the Federal Circuit upheld the judgment of the U.S. District Court for the<br> District of Delaware that certain claims of the patents protecting Belbuca are valid. Collegium<br> expects that, by virtue of the Federal Circuit’s decision, Alvogen will be barred from<br> entering the market with its product until 2032 |
| --- | --- |
| ● | Completed<br> Xtampza ER contract renegotiations in 2022, maintaining broad access while significantly<br> decreasing rebates; Xtampza ER gross-to-net is expected to be in the range of 61% to 63%<br> in 2023 |
| --- | --- |
FinancialGuidance for 2023
| ● | Product<br> revenues, net are expected in the range of $565.0 million to $580.0 million |
|---|---|
| ● | Adjusted<br> operating expenses (excluding stock-based compensation) are expected in the range of $135.0<br> million to $145.0 million |
| --- | --- |
| ● | Adjusted<br> EBITDA (excluding stock-based compensation) is expected in the range of $355.0 million to<br> $370.0 million |
| --- | --- |
* Non-GAAP financial measure. Please refer to the “Non-GAAP Financial Measures” section for details regarding these measures.
AboutCollegium Pharmaceutical, Inc.
Collegium is a 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-GAAPFinancial Measures
We have included information about certain non-GAAP financial measures in this press release. 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, where applicable, 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 press release we discuss the following financial measures that are not calculated in accordance with GAAP.
AdjustedEBITDA
Adjusted EBITDA is a non-GAAP financial measure that represents GAAP net income 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, which is the nearest GAAP equivalent, such as:
| ● | adjusted<br> EBITDA excludes depreciation and amortization, and, although these are non-cash expenses,<br> the assets being depreciated or amortized may have to be replaced in the future, the cash<br> requirements for which are not reflected in adjusted EBITDA; |
|---|---|
| ● | we<br> exclude stock-based compensation expense from adjusted EBITDA although (a) it has been, and<br> will continue to be for the foreseeable future, a significant recurring expense for our business<br> and an important part of our compensation strategy and (b) if we did not pay out a portion<br> of our compensation in the form of stock-based compensation, the cash salary expense included<br> in operating expenses would be higher, which would affect our cash position; |
| --- | --- |
| ● | adjusted<br> EBITDA does not reflect changes in, or cash requirements for, working capital needs; |
| --- | --- |
| ● | adjusted<br> EBITDA does not reflect the benefit from or provision for income taxes or the cash requirements<br> to pay taxes; |
| --- | --- |
| ● | adjusted<br> EBITDA does not reflect historical cash expenditures or future requirements for capital expenditures<br> or contractual commitments; |
| --- | --- |
| ● | we<br> exclude restructuring expenses from adjusted EBITDA. Restructuring expenses primarily include<br> employee severance and contract termination costs that are not related to acquisitions. The<br> amount and/or frequency of these restructuring expenses are not part of our underlying business; |
|---|---|
| ● | we<br> exclude litigation settlements from adjusted EBITDA, as well as any applicable income items<br> or credit adjustments due to subsequent changes in estimates. This does not include our legal<br> fees to defend claims, which are expensed as incurred; |
| --- | --- |
| ● | we<br> exclude acquisition related expenses as the amount and/or frequency of these expenses are<br> not part of our underlying business. Acquisition related expenses include transaction costs,<br> which primarily consist of financial advisory, banking, legal, and regulatory fees, and other<br> consulting fees, incurred to complete an acquisition, employee-related expenses (severance<br> cost and benefits) for terminated employees after the acquisition, and miscellaneous other<br> acquisition expenses incurred; and |
| --- | --- |
| ● | we<br> exclude recognition of the step-up basis in inventory from acquisitions (i.e., the adjustment<br> to record inventory from historic cost to fair value at acquisition) as the adjustment does<br> not reflect the ongoing expense associated with sale of our products as part of our underlying<br> business. |
| --- | --- |
AdjustedOperating 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.
We have not provided a reconciliation of our 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 we are 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 we are 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 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-LookingStatements
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.
InvestorContact:
Dawn Schottlandt Argot Partners
collegium@argotpartners.com
MediaContact:
Marissa Samuels
Corporate Communications
communications@collegiumpharma.com
Exhibit 99.2
| Investor Presentation<br>January 2023<br>Nasdaq: COLL |
|---|
| Forward<br>-<br>Looking<br>Statements<br>This<br>presentation<br>contains<br>forward<br>-<br>looking<br>statements<br>within<br>the<br>meaning<br>of<br>The<br>Private<br>Securities<br>Litigation<br>Reform<br>Act<br>of<br>1995<br>..<br>We<br>may,<br>in<br>some<br>cases,<br>use<br>terms<br>such<br>as<br>"predicts,"<br>"forecasts,"<br>"believes,"<br>"potential,"<br>"proposed,"<br>"continue,"<br>"estimates,"<br>"anticipates,"<br>"expects,"<br>"plans,"<br>"intends,"<br>"may,"<br>"could,"<br>"might,"<br>"should"<br>or<br>other<br>words<br>that<br>convey<br>uncertainty<br>of<br>future<br>events<br>or<br>outcomes<br>to<br>identify<br>these<br>forward<br>-<br>looking<br>statements<br>..<br>Examples<br>of<br>forward<br>-<br>looking<br>statements<br>contained<br>in<br>this<br>press<br>release<br>include,<br>among<br>others,<br>statements<br>related<br>to<br>our<br>full<br>-<br>year<br>2023<br>financial<br>guidance,<br>including<br>projected<br>product<br>revenue,<br>adjusted<br>operating<br>expenses<br>and<br>adjusted<br>EBITDA,<br>current<br>and<br>future<br>market<br>opportunities<br>for<br>our<br>products<br>and<br>our<br>assumptions<br>related<br>thereto,<br>expectations<br>(financial<br>or<br>otherwise)<br>and<br>intentions,<br>and<br>other<br>statements<br>that<br>are<br>not<br>historical<br>facts<br>..<br>Such<br>statements<br>are<br>subject<br>to<br>numerous<br>important<br>factors,<br>risks<br>and<br>uncertainties<br>that<br>may<br>cause<br>actual<br>events<br>or<br>results,<br>performance,<br>or<br>achievements<br>to<br>differ<br>materially<br>from<br>the<br>company's<br>current<br>expectations,<br>including<br>risks<br>relating<br>to,<br>among<br>others<br>:<br>risks<br>related<br>to<br>the<br>ability<br>to<br>realize<br>the<br>anticipated<br>benefits<br>of<br>our<br>acquisitions<br>at<br>all<br>or<br>within<br>the<br>expected<br>time<br>period<br>;<br>unknown<br>liabilities<br>;<br>risks<br>related<br>to<br>future<br>opportunities<br>and<br>plans<br>for<br>our<br>products,<br>including<br>uncertainty<br>of<br>the<br>expected<br>financial<br>performance<br>of<br>such<br>products<br>;<br>the<br>impact<br>of<br>the<br>COVID<br>-<br>19<br>pandemic<br>on<br>our<br>ability<br>to<br>conduct<br>our<br>business,<br>reach<br>our<br>customers,<br>and<br>supply<br>the<br>market<br>with<br>our<br>products<br>;<br>our<br>ability<br>to<br>commercialize<br>and<br>grow<br>sales<br>of<br>our<br>products<br>;<br>our<br>ability<br>to<br>manage<br>our<br>relationships<br>with<br>licensors<br>;<br>the<br>success<br>of<br>competing<br>products<br>that<br>are<br>or<br>become<br>available<br>;<br>our<br>ability<br>to<br>obtain<br>and<br>maintain<br>regulatory<br>approval<br>of<br>our<br>products<br>and<br>any<br>product<br>candidates,<br>and<br>any<br>related<br>restrictions,<br>limitations,<br>and/or<br>warnings<br>in<br>the<br>label<br>of<br>an<br>approved<br>product<br>;<br>the<br>size<br>of<br>the<br>markets<br>for<br>our<br>products<br>and<br>product<br>candidates,<br>and<br>our<br>ability<br>to<br>service<br>those<br>markets<br>;<br>our<br>ability<br>to<br>obtain<br>reimbursement<br>and<br>third<br>-<br>party<br>payor<br>contracts<br>for<br>our<br>products<br>;<br>the<br>rate<br>and<br>degree<br>of<br>market<br>acceptance<br>of<br>our<br>products<br>and<br>product<br>candidates<br>;<br>the<br>costs<br>of<br>commercialization<br>activities,<br>including<br>marketing,<br>sales<br>and<br>distribution<br>;<br>changing<br>market<br>conditions<br>for<br>our<br>products<br>;<br>the<br>outcome<br>of<br>any<br>patent<br>infringement<br>or<br>other<br>litigation<br>that<br>may<br>be<br>brought<br>by<br>or<br>against<br>us<br>;<br>the<br>outcome<br>of<br>any<br>governmental<br>investigation<br>related<br>to<br>our<br>business<br>;<br>our<br>ability<br>to<br>secure<br>adequate<br>supplies<br>of<br>active<br>pharmaceutical<br>ingredient<br>for<br>each<br>of<br>our<br>products<br>and<br>manufacture<br>adequate<br>supplies<br>of<br>commercially<br>saleable<br>inventory<br>;<br>our<br>ability<br>to<br>obtain<br>funding<br>for<br>our<br>operations<br>and<br>business<br>development<br>;<br>regulatory<br>developments<br>in<br>the<br>U<br>..<br>S<br>..;<br>our<br>expectations<br>regarding<br>our<br>ability<br>to<br>obtain<br>and<br>maintain<br>sufficient<br>intellectual<br>property<br>protection<br>for<br>our<br>products<br>;<br>our<br>ability<br>to<br>comply<br>with<br>stringent<br>U<br>..<br>S<br>..<br>and<br>foreign<br>government<br>regulation<br>in<br>the<br>manufacture<br>of<br>pharmaceutical<br>products,<br>including<br>U<br>..<br>S<br>..<br>Drug<br>Enforcement<br>Agency,<br>or<br>DEA,<br>compliance<br>;<br>our<br>customer<br>concentration<br>;<br>and<br>the<br>accuracy<br>of<br>our<br>estimates<br>regarding<br>expenses,<br>revenue,<br>capital<br>requirements<br>and<br>need<br>for<br>additional<br>financing<br>..<br>These<br>and<br>other<br>risks<br>are<br>described<br>under<br>the<br>heading<br>"Risk<br>Factors"<br>in<br>our<br>Annual<br>Reports<br>on<br>Form<br>10<br>-<br>K<br>and<br>Quarterly<br>Reports<br>on<br>Form<br>10<br>-<br>Q<br>and<br>other<br>filings<br>with<br>the<br>SEC<br>..<br>Any<br>forward<br>-<br>looking<br>statements<br>that<br>we<br>make<br>in<br>this<br>presentation<br>speak<br>only<br>as<br>of<br>the<br>date<br>of<br>this<br>presentation<br>..<br>We<br>assume<br>no<br>obligation<br>to<br>update<br>our<br>forward<br>-<br>looking<br>statements<br>whether<br>as<br>a<br>result<br>of<br>new<br>information,<br>future<br>events<br>or<br>otherwise,<br>after<br>the<br>date<br>of<br>this<br>presentation<br>..<br>Non<br>-<br>GAAP<br>Financial<br>Measures<br>To<br>supplement<br>our<br>financial<br>results<br>presented<br>on<br>a<br>GAAP<br>basis,<br>we<br>have<br>included<br>information<br>about<br>certain<br>non<br>-<br>GAAP<br>financial<br>measures<br>..<br>We<br>use<br>these<br>non<br>-<br>GAAP<br>financial<br>measures<br>to<br>understand,<br>manage<br>and<br>evaluate<br>our<br>business<br>as<br>we<br>believe<br>they<br>provide<br>additional<br>information<br>on<br>the<br>performance<br>of<br>our<br>business<br>..<br>We<br>believe<br>that<br>the<br>presentation<br>of<br>these<br>non<br>-<br>GAAP<br>financial<br>measures,<br>taken<br>in<br>conjunction<br>with<br>our<br>results<br>under<br>GAAP,<br>provide<br>analysts,<br>investors,<br>lenders<br>and<br>other<br>third<br>parties<br>insight<br>into<br>our<br>view<br>and<br>assessment<br>of<br>our<br>ongoing<br>operating<br>performance<br>..<br>In<br>addition,<br>we<br>believe<br>that<br>the<br>presentation<br>of<br>these<br>non<br>-<br>GAAP<br>financial<br>measures,<br>when<br>viewed<br>with<br>our<br>results<br>under<br>GAAP<br>and<br>the<br>accompanying<br>reconciliations,<br>provide<br>supplementary<br>information<br>that<br>may<br>be<br>useful<br>to<br>analysts,<br>investors,<br>lenders,<br>and<br>other<br>third<br>parties<br>in<br>assessing<br>our<br>performance<br>and<br>results<br>from<br>period<br>to<br>period<br>..<br>We<br>report<br>these<br>non<br>-<br>GAAP<br>financial<br>measures<br>to<br>portray<br>the<br>results<br>of<br>our<br>operations<br>prior<br>to<br>considering<br>certain<br>income<br>statement<br>elements<br>..<br>These<br>non<br>-<br>GAAP<br>financial<br>measures<br>should<br>be<br>considered<br>in<br>addition<br>to,<br>and<br>not<br>as<br>a<br>substitute<br>for,<br>or<br>superior<br>to,<br>net<br>income<br>or<br>other<br>financial<br>measures<br>calculated<br>in<br>accordance<br>with<br>GAAP<br>..<br>In<br>this<br>presentation,<br>we<br>discuss<br>the<br>following<br>financial<br>measures<br>that<br>are<br>not<br>calculated<br>in<br>accordance<br>with<br>GAAP,<br>to<br>supplement<br>our<br>consolidated<br>financial<br>statements<br>presented<br>on<br>a<br>GAAP<br>basis<br>..<br>Adjusted<br>EBITDA<br>Adjusted<br>EBITDA<br>is<br>a<br>non<br>-<br>GAAP<br>financial<br>measure<br>that<br>represents<br>GAAP<br>net<br>income<br>adjusted<br>to<br>exclude<br>interest<br>expense,<br>interest<br>income,<br>the<br>benefit<br>from<br>or<br>provision<br>for<br>income<br>taxes,<br>depreciation,<br>amortization,<br>stock<br>-<br>based<br>compensation,<br>and<br>other<br>adjustments<br>to<br>reflect<br>changes<br>that<br>occur<br>in<br>our<br>business<br>but<br>do<br>not<br>represent<br>ongoing<br>operations<br>..<br>Adjusted<br>EBITDA,<br>as<br>used<br>by<br>us,<br>may<br>be<br>calculated<br>differently<br>from,<br>and<br>therefore<br>may<br>not<br>be<br>comparable<br>to,<br>similarly<br>titled<br>measures<br>used<br>by<br>other<br>companies<br>..<br>There<br>are<br>several<br>limitations<br>related<br>to<br>the<br>use<br>of<br>adjusted<br>EBITDA<br>rather<br>than<br>net<br>income,<br>which<br>is<br>the<br>nearest<br>GAAP<br>equivalent,<br>such<br>as<br>:<br> •<br>adjusted<br>EBITDA<br>excludes<br>depreciation<br>and<br>amortization,<br>and,<br>although<br>these<br>are<br>non<br>-<br>cash<br>expenses,<br>the<br>assets<br>being<br>depreciated<br>or<br>amortized<br>may<br>have<br>to<br>be<br>replaced<br>in<br>the<br>future,<br>the<br>cash<br>requirements<br>for<br>which<br>are<br>not<br>reflected<br>in<br>adjusted<br>EBITDA<br>;<br> •<br>we<br>exclude<br>stock<br>-<br>based<br>compensation<br>expense<br>from<br>adjusted<br>EBITDA<br>although<br>(a)<br>it<br>has<br>been,<br>and<br>will<br>continue<br>to<br>be<br>for<br>the<br>foreseeable<br>future,<br>a<br>significant<br>recurring<br>expense<br>for<br>our<br>business<br>and<br>an<br>important<br>part<br>of<br>our<br>compensation<br>strategy<br>and<br>(b)<br>if<br>we<br>did<br>not<br>pay<br>out<br>a<br>portion<br>of<br>our<br>compensation<br>in<br>the<br>form<br>of<br>stock<br>-<br>based<br>compensation,<br>the<br>cash<br>salary<br>expense<br>included<br>in<br>operating<br>expenses<br>would<br>be<br>higher,<br>which<br>would<br>affect<br>our<br>cash<br>position<br>;<br> •<br>adjusted<br>EBITDA<br>does<br>not<br>reflect<br>changes<br>in,<br>or<br>cash<br>requirements<br>for,<br>working<br>capital<br>needs<br>;<br> •<br>adjusted<br>EBITDA<br>does<br>not<br>reflect<br>the<br>benefit<br>from<br>or<br>provision<br>for<br>income<br>taxes<br>or<br>the<br>cash<br>requirements<br>to<br>pay<br>taxes<br>;<br> •<br>adjusted<br>EBITDA<br>does<br>not<br>reflect<br>historical<br>cash<br>expenditures<br>or<br>future<br>requirements<br>for<br>capital<br>expenditures<br>or<br>contractual<br>commitments<br>;<br> •<br>we<br>exclude<br>restructuring<br>expenses<br>from<br>adjusted<br>EBITDA<br>..<br>Restructuring<br>expenses<br>primarily<br>include<br>employee<br>severance<br>and<br>contract<br>termination<br>costs<br>that<br>are<br>not<br>related<br>to<br>acquisitions<br>..<br>The<br>amount<br>and/or<br>frequency<br>of<br>these<br>restructuring<br>expenses<br>are<br>not<br>part<br>of<br>our<br>underlying<br>business<br>;<br> •<br>we<br>exclude<br>litigation<br>settlements<br>from<br>adjusted<br>EBITDA,<br>as<br>well<br>as<br>any<br>applicable<br>income<br>items<br>or<br>credit<br>adjustments<br>due<br>to<br>subsequent<br>changes<br>in<br>estimates<br>..<br>This<br>does<br>not<br>include<br>our<br>legal<br>fees<br>to<br>defend<br>claims,<br>which<br>are<br>expensed<br>as<br>incurred<br>;<br> •<br>we<br>exclude<br>acquisition<br>related<br>expenses<br>as<br>the<br>amount<br>and/or<br>frequency<br>of<br>these<br>expenses<br>are<br>not<br>part<br>of<br>our<br>underlying<br>business<br>..<br>Acquisition<br>related<br>expenses<br>include<br>transaction<br>costs,<br>which<br>primarily<br>consist<br>of<br>financial<br>advisory,<br>banking,<br>legal,<br>and<br>regulatory<br>fees,<br>and<br>other<br>consulting<br>fees,<br>incurred<br>to<br>complete<br>an<br>acquisition,<br>employee<br>-<br>related<br>expenses<br>(severance<br>cost<br>and<br>benefits)<br>for<br>terminated<br>employees<br>after<br>the<br>acquisition,<br>and<br>miscellaneous<br>other<br>acquisition<br>expenses<br>incurred<br>;<br>and<br> •<br>we<br>exclude<br>recognition<br>of<br>the<br>step<br>-<br>up<br>basis<br>in<br>inventory<br>from<br>acquisitions<br>(i<br>..<br>e<br>..<br>,<br>the<br>adjustment<br>to<br>record<br>inventory<br>from<br>historic<br>cost<br>to<br>fair<br>value<br>at<br>acquisition)<br>as<br>the<br>adjustment<br>does<br>not<br>reflect<br>the<br>ongoing<br>expense<br>associated<br>with<br>sale<br>of<br>our<br>products<br>as<br>part<br>of<br>our<br>underlying<br>business<br>..<br>Adjusted<br>Operating<br>Expenses<br>Adjusted<br>operating<br>expenses<br>is<br>a<br>non<br>-<br>GAAP<br>financial<br>measure<br>that<br>represents<br>GAAP<br>operating<br>expenses<br>adjusted<br>to<br>exclude<br>stock<br>-<br>based<br>compensation<br>expense,<br>and<br>other<br>adjustments<br>to<br>reflect<br>changes<br>that<br>occur<br>in<br>our<br>business<br>but<br>do<br>not<br>represent<br>ongoing<br>operations<br>..<br>Reconciliations<br>of<br>adjusted<br>EBITDA<br>and<br>adjusted<br>operating<br>expenses<br>for<br>completed<br>periods<br>to<br>the<br>most<br>directly<br>comparable<br>GAAP<br>financial<br>measures<br>are<br>included<br>in<br>this<br>presentation<br>..<br>We<br>have<br>not<br>provided<br>a<br>reconciliation<br>of<br>our<br>full<br>-<br>year<br>2023<br>guidance<br>for<br>adjusted<br>EBITDA<br>or<br>adjusted<br>operating<br>expenses<br>to<br>the<br>most<br>directly<br>comparable<br>forward<br>-<br>looking<br>GAAP<br>measures,<br>in<br>reliance<br>on<br>the<br>unreasonable<br>efforts<br>exception<br>provided<br>under<br>Item<br>10<br>(e)(<br>1<br>)(i)(B)<br>of<br>Regulation<br>S<br>-<br>K,<br>because<br>we<br>are<br>unable<br>to<br>predict,<br>without<br>unreasonable<br>efforts,<br>the<br>timing<br>and<br>amount<br>of<br>items<br>that<br>would<br>be<br>included<br>in<br>such<br>a<br>reconciliation,<br>including,<br>but<br>not<br>limited<br>to,<br>stock<br>-<br>based<br>compensation<br>expense,<br>acquisition<br>related<br>expense<br>and<br>litigation<br>settlements<br>..<br>These<br>items<br>are<br>uncertain<br>and<br>depend<br>on<br>various<br>factors<br>that<br>are<br>outside<br>of<br>the<br>Company’s<br>control<br>or<br>cannot<br>be<br>reasonably<br>predicted<br>..<br>While<br>we<br>are<br>unable<br>to<br>address<br>the<br>probable<br>significance<br>of<br>these<br>items,<br>they<br>could<br>have<br>a<br>material<br>impact<br>on<br>GAAP<br>net<br>income<br>and<br>operating<br>expenses<br>for<br>the<br>guidance<br>period<br>..<br>A<br>reconciliation<br>adjusted<br>EBITDA<br>or<br>adjusted<br>operating<br>expenses<br>would<br>imply<br>a<br>degree<br>of<br>precision<br>and<br>certainty<br>as<br>to<br>these<br>future<br>items<br>that<br>does<br>not<br>exist<br>and<br>could<br>be<br>confusing<br>to<br>investors<br>..<br>2 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| Healthier people.<br>Stronger communities.<br>Mission Driven<br>Building a leading, diversified specialty pharmaceutical<br>company committed to improving the lives of people<br>living with serious medical conditions.<br>Guided by Our<br>Core Values<br>Uphold Integrity<br>Embrace Differences<br>Encourage Expression<br>Be Accountable<br>I<br>D<br>E<br>A<br>We maintain uncompromising<br>integrity<br>in everything we<br>say and do.<br>We<br>embrace<br>differences as<br>they make our ideas richer and<br>serve our patients better.<br>We<br>encourage<br>everyone to<br>think big, push ourselves and<br>make our voices heard.<br>We are<br>accountable<br>to each<br>other, our customers and<br>our community.<br>3 |
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| 4<br>Committed to Sustainability, Social Impact and Ethical Governance<br>Planning Inaugural ESG Report Publication in First Quarter 2023<br>E<br>nvironmental<br>Be a responsible steward<br>of the environment<br> •<br>Focusing on identifying and mitigating<br>manufacturing inefficiencies<br> •<br>Evaluating greenhouse gas emissions<br>reduction opportunities<br> •<br>Evaluating waste management<br>improvements<br>S<br>ocial<br>Do the right thing for our employees,<br>patients, providers, customers and<br>communities<br> •<br>Strengthening customer relationships by<br>leading with the science<br> •<br>Fostering DEI through Collegium DEI<br>Council initiatives<br> •<br>Promoting corporate social responsibility<br>with charitable giving and volunteering<br> •<br>Deepening employee engagement through<br>career development and well<br>-<br>being<br>programming<br>G<br>overnance<br>Act in the best interests of our<br>stakeholders<br> •<br>Operating with the highest ethical<br>standards<br> •<br>Implementing governance that promotes<br>transparency<br> •<br>Protecting shareholder value with risk<br>management and Board oversight<br> •<br>Aligning management and shareholder<br>interests with compensation and policies |
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| 5<br>Building a Leading, Diversified Specialty Pharmaceutical Company<br>Strong Financial<br>Position<br> •<br>Durable revenue with<br>targeted growth<br>opportunities<br> •<br>Positioned to grow adjusted<br>EBITDA at >1.5x revenue and<br> >4x adjusted operating<br>expenses in 2023<br>1<br> •<br>Strong, growing cash<br>generation<br> •<br>Healthy balance sheet<br>Disciplined Capital<br>Allocation<br> •<br>Focused business<br>development strategy<br> •<br>Rapid debt pay<br>-<br>down<br> •<br>Share repurchase plan<br>available to opportunistically<br>return capital to<br>shareholders<br>Leading<br>Commercial<br>Portfolio<br> •<br>Leader in responsible pain<br>management<br> •<br>Differentiated and distinctly<br>positioned pain portfolio<br>spanning the continuum of<br>care<br> •<br>Anchored by two growth<br>drivers, Belbuca<br> ®<br>and<br>Xtampza<br> ®<br>ER, with Nucynta<br>Franchise and Symproic<br> ®<br>as<br>significant contributors<br>Investment Highlights<br> —<br>Our Path to Long<br>-<br>term Value Creation<br>1.<br>A<br>djusted<br>EBITDA and adjusted operating<br>e<br>xpenses<br>are non<br>-<br>GAAP financial measures.<br>See Non<br>-<br>GAAP Financial Measures on Slide 2. Adjusted EBITDA to revenue and adjusted EBITDA to adjusted<br>operating expenses are calculated based on the mid<br>-<br>point of the 2022 guidance ranges provided by Collegium in its press release<br>filed with the SEC on November 3,<br>2022<br>compared to the mid<br>-<br>point<br>of the 2023 guidance ranges provided by Collegium in its press release filed with the SEC on January 4, 2023. |
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| The Collegium Story<br>2002<br>Collegium formed to address<br>opioid epidemic through<br>development of prescription pain<br>treatments with abuse<br>-<br>deterrent<br>properties<br>Collegium’s first product,<br>Xtampza ER, FDA approved<br>Formulated with<br>DETERx<br> ®<br>, a<br>proprietary abuse<br>-<br>deterrent<br>technology, designed to deter<br>common methods of abuse and<br>misuse<br>2016<br>2020<br>-<br>2022<br>Collegium becomes leader in<br>responsible pain management<br>through acquisition of Nucynta<br>Franchise and Belbuca<br>Broad pain portfolio with four<br>products distinctly positioned to treat<br>acute and chronic pain responsibly<br>Expand portfolio through<br>business development to<br>address unmet need and<br>improve the lives of people<br>living with serious medical<br>conditions<br>2023 →<br>Rise of opioid epidemic in<br>the U.S. marked by sharp<br>increases in prescription<br>opioid overdose deaths<br>1990s<br>-<br>2000s<br>6 |
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| Collegium’s Operational Excellence in 2022<br>2022 Financial<br>Guidance<br>4<br> •<br>Product revenues, net:<br>$455<br>-<br>465M<br> •<br>Adjusted operating<br>expenses:<br>$125<br>-<br>130M<br>1<br> •<br>Adjusted EBITDA:<br>$250<br>-<br>255M<br>1<br>Improving<br>Operating Margins<br> •<br>Recognize<br>targeted run<br>rate BDSI synergies of<br>~$85 million<br> •<br>Grow<br>adjusted EBITDA<br> •<br>Maintain<br>financial<br>discipline<br> •<br>Build<br>cash position<br>Deployed<br>Capital<br> ✓<br>Acquired BDSI,<br>expanding leadership<br>position in responsible<br>pain management<br> ✓<br>Rapidly<br>paid down debt,<br>expect to end 2022 with<br>net debt/adjusted EBITDA<br> <3.0<br>1,2<br> ✓<br>Opportunistically<br>returned $<br>19.1M<br>of<br>capital to shareholders<br>through share<br>repurchases in 2022<br>3<br>Executed on Business<br>Initiatives<br> ✓<br>Renegotiated<br>Xtampza<br>ER contracts to improve<br>GTNs to <65% in 2023<br> ✓<br>Achieved<br>Phases 1 and 2<br>of Three Phase Action<br>Agenda<br> ✓<br>Resolved<br>all 27 pending<br>opioid industry<br>-<br>related<br>lawsuits<br>7<br>2022 Guidance Reflects Strength:<br>Successfully:<br>1.<br>A<br>djusted<br>EBITDA and adjusted operating expenses are non<br>-<br>GAAP financial measures.<br>See Non<br>-<br>GAAP Financial Measures on Slide 2.<br>2.<br>The net debt/adjusted EBITDA ratio is calculated based on financial data provided by Collegium on Form 10<br>-<br>Q filed with the SEC o<br>n November 3,<br>2022<br>compared to the mid<br>-<br>point of the guidance ranges provided by<br>Collegium in its press release filed with the SEC on November 3, 2022. Details regarding the Pharmakon term<br>-<br>loan debt amortizati<br>on schedule provided by Collegium on form SC TO<br>-<br>C filed with the SEC on February 14, 2022.<br>3.<br>This financial data was provided by Collegium in its press release filed with the SEC on January 4, 2023.<br>4.<br>This financial data was provided by Collegium in its press release filed with the SEC on<br>November 3, 2022. |
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| $118M<br>$253M<br>$363M<br>2021<br>2022E<br>2023E<br>Adjusted EBITDA<br>3<br>1<br>$277M<br>$460M<br>$573M<br>2021<br>2022E<br>2023E<br>Product Revenues, Net<br>8<br>2023 To Be A Banner Year<br>1<br>2<br>2<br>1.<br>This financial data was provided by Collegium in its press release filed with the SEC on<br>November 3,<br>2022<br>and represents the mid<br>-<br>point of 2022 guidance ranges.<br>2.<br>This financial data was provided by Collegium in its press release filed with the SEC on<br>Januar<br>y 4,<br>2023<br>and represents the mid<br>-<br>point of 2023 guidance ranges.<br>3.<br>Adjusted operating<br>e<br>xpenses<br>and adjusted EBITDA are non<br>-<br>GAAP financial measures.<br>See Non<br>-<br>GAAP Financial Measures on Slide 2.<br>+44%<br>CAGR<br>+75%<br>CAGR<br>$101M<br>$128M<br>$140M<br>2021<br>2022E<br>2023E<br>Adjusted Operating Expenses<br>3<br>ACCELERATE GROWTH<br>LEVERAGE<br>GENERATE RETURNS<br>+18%<br>CAGR<br>1<br>2 |
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| Strategy for a Banner 2023<br> •<br>Generate<br>strong cash flow<br>from pain portfolio through<br>commercial execution and<br>leveraging cost structure<br> •<br>Grow<br>Belbuca and Xtampza ER<br>market share<br> •<br>Maximize<br>Nucynta Franchise<br>and Symproic<br> •<br>Conduct<br>business development<br>focused on commercial<br>-<br>stage,<br>durable assets<br> •<br>Rapidly<br>pay down debt<br> •<br>Opportunistically<br>return<br>capital to shareholders<br>Maximize Portfolio<br>Deploy Capital<br>9 |
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| Action Agenda Phase 3: Accelerate Top<br>-<br>and Bottom<br>-<br>Line<br>Phase 1<br>(03/22/22<br> –<br>06/30/22)<br>Seamless Integration<br>1.<br>Executed with no disruptions to<br>core operations<br>2.<br>Achieved day one field force<br>readiness<br>3.<br>Realized majority of targeted run<br>rate synergies<br>Phase 2<br>(07/01/22<br> –<br>12/31/22)<br>Generate Momentum<br>1.<br>Grew Belbuca and Xtampza ER<br>2.<br>Completed Xtampza ER contract<br>renegotiations<br>3.<br>Achieved remainder of target<br>synergies<br>4.<br>Synthesized Elyxyb<br> ™<br>launch<br>learnings<br>Phase 3<br>(2023)<br>Accelerate Top<br>-<br>and Bottom<br>-<br>Line<br>1.<br>Propelled by Xtampza ER gross<br>-<br>to<br>-<br>net of <65%<br>starting in January 2023<br>2.<br>Driven by Belbuca and Xtampza ER TRx growth<br>3.<br>Bolstered by fully synergized cost structure<br>2023<br>COMPLETED<br>10 |
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| Sources:<br>1.<br>IQVIA NPA, November 2022 (Belbuca, Xtampza ER, and Nucynta<br> ®<br>ER).<br>11<br>Leading Pain<br>Portfolio Spans the Continuum of Care<br>Acute<br>Chronic<br>Collegium’s portfolio holds 50% market share of the branded ER market<br>1<br> •<br>Immediate<br>-<br>release<br>formulation of tapentadol<br> •<br>Extended<br>-<br>release<br>buprenorphine<br> •<br>Classified as schedule III<br>controlled substance<br> •<br>Extended<br>-<br>release formulation<br>of tapentadol<br> •<br>Only extended<br>-<br>release drug<br>approved for neuropathic pain<br>associated with diabetic<br>peripheral neuropathy<br> •<br>Extended<br>-<br>release oxycodone<br> •<br>Formulated with DETERx, an<br>abuse<br>-<br>deterrent technology<br> •<br>Labeling includes human abuse<br>potential studies<br>Pain Portfolio Distinctly Positioned to Treat Acute and Chronic Pain Responsibly |
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| Sources:<br>1.<br>IQVIA NPA through November 2022.<br>2.<br>IQVIA Xponent through September 2022.<br>12<br>Xtampza ER and Belbuca: Strong and Growing Market Position<br>Strong Market Position<br>Growing Prescriber Base<br>GtN Impacts<br>Market Access<br>35.6% share<br>of<br>OER market<br>1<br>~19,300 unique<br>prescribers<br>in Q3 2022,<br>up 0.2% Q3’22 vs. Q3’21<br>2<br>Expect<br>61<br>-<br>63%<br>GtN<br>Strong coverage<br>across<br>all<br>payor<br>types<br>38.2% share<br>of growing<br>buprenorphine market<br>1<br>~9,100 unique<br>prescribers<br>in Q3 2022,<br>up 1.6% Q3’22 vs. Q3’21<br>2<br>Expect<br>stable<br>GtN<br>Strong<br>commercial<br>coverage |
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| Xtampza ER<br>GtN<br>Successfully Renegotiated to Less than 65%<br>54%<br>of Xtampza ER<br>Prescriptions<br>Plans representing 54% of Xtampza ER<br>prescriptions successfully renegotiated to support<br>GtN<br>of 61<br>-<br>63% in 2023<br>90%<br>of the Current<br>Prescription<br>Base<br>~90% of the renegotiated contracts will maintain<br>Xtampza ER as its exclusive ER oxycodone position or<br>parity position with OxyContin<br>13 |
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| Focused on Maximizing the Value of Nucynta Franchise and Symproic<br>Sources:<br>1.<br>Nucynta Full Prescribing Information, 2022.<br>2.<br>Nucynta ER Full Prescribing Information, 2022.<br>3.<br>IQVIA Xponent through October 2022.<br>4.<br>Crockett SD, et al.<br>Gastroenterology. 2019;156(1): 218<br>-<br>226.<br>14<br> •<br>Differentiated opioid with proposed<br>dual mechanism of action<br>1,2<br> •<br>Nucynta<br> ®<br>ER is the only ER product<br>indicated for pain associated with<br>Diabetic Peripheral Neuropathy<br>2<br> •<br>~70% of Nucynta Franchise<br>prescriptions are covered by the pain<br>salesforce<br>3<br> •<br>Maximize profitability through<br>contracting strategy<br> •<br>The only OIC therapy with a<br>strong<br>recommendation and<br>high quality of<br>evidence from the American<br>Gastroenterological Association<br>4<br> •<br>Complementary to pain portfolio |
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| Reflects (i) for Xtampza ER, the September 2033 entry date set forth in Collegium’s settlement agreement with Teva; (ii) for<br>Bel<br>buca, the January 2027 entry date set forth<br>in BDSI’s settlement agreement with Teva; (iii) for the Nucynta franchise, and based on the judgment upholding its Orange<br>-<br>Book l<br>isted patents, the July 2025 expiry of<br>such patents; and (iv) for Symproic, which does not have any ANDA filers yet, the November 2031 expiry of its Orange Book<br>-<br>listed<br>patents.<br>15<br>Patent<br>Protected<br>Commercial Portfolio<br>Contributors<br>Growth Drivers<br>Sept 2033<br>Jan 2027<br>2036<br>2032<br>July 2025<br>Nov 2031<br>2028<br>ER Only<br>Teva currently is the<br>only<br>generic<br>manufacturer<br>that<br>has resolved legal challenges to<br>its Xtampza ER and Belbuca ANDAs.<br>Teva does not have tentative or final approval<br>for<br>either<br>ANDA and has<br>waived<br>its first filer exclusivity with respect to Belbuca.<br>Projected<br>Exclusivity<br>Latest Patent<br>Expiry |
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| 1.<br>Adjusted EBITDA is a non<br>-<br>GAAP financial measure. See Non<br>-<br>GAAP Financial Measures on Slide 2. The 2022 and 2023 net debt/adjusted<br>EBITDA ratios are calculated based on financial data provided by Collegium<br>on Form 10<br>-<br>Q filed with the SEC on November 3,<br>2022<br>compared to the mid<br>-<br>point of the 2022 guidance ranges provided by Collegium in its press release filed with the SEC on<br>November 3, 2022, and<br>compared<br>to the mid<br>-<br>point of the 2023 guidance ranges provided by Collegium in its press release filed with the SEC on January 4, 2023, r<br>espectively. This financial data assumes no additional debt is incurred.<br>2.<br>Details regarding the Pharmakon term<br>-<br>loan debt amortization schedule provided by Collegium on form SC TO<br>-<br>C filed with the SEC on<br>February 14, 2022.<br>3.<br>This financial data was provided by Collegium on Form 10<br>-<br>K filed with the SEC on February 24,<br>2022<br>and in its press release filed with the SEC on January 4, 2023.<br>16<br>Capital Allocation Priorities Focused on Long<br>-<br>Term Value Creation<br> •<br>Targeting commercial<br>-<br>stage<br>assets to diversify specialty<br>pharmaceutical portfolio<br> •<br>Peak sales potential of >$150M<br> •<br>Differentiated product with a<br>leading market position<br> •<br>Durable with exclusivity into 2030s<br>Focused Business<br>Development<br> •<br>Expect net debt/adjusted<br>EBITDA to be <3.0 by year<br>-<br>end<br>2022 and <1.5x by year<br>-<br>end<br>2023<br>1,2<br> •<br>Tracking to repay >$160M of<br>Pharmakon loan ($650M issued<br>3/22/2021) by year<br>-<br>end 2023<br>2<br>Rapidly<br>Paydown Debt<br> •<br>Strong track record of<br>opportunistic share repurchases<br> •<br>Returned $42.9M and $<br>19.1M<br>to<br>shareholders in 2021 and 2022,<br>respectively<br>3<br> •<br>2023 share repurchase plan<br>authorizes up to $100M<br>Return Capital<br>to Shareholders |
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| $104M<br>$104M<br>$173M<br>$230M<br>2021<br>9 Mos. 2022<br>Product Revenues, Net<br>$334M<br>2021<br>9 Mos. 2022<br>Adjusted EBITDA<br>2<br>Business Development is Top Capital Allocation Priority<br>Strong Track Record of Successful<br>Business Development<br> •<br>Expanded top<br>-<br>and bottom<br>-<br>line with<br>Nucynta Franchise (February 2020) and<br>BDSI (March 2022) acquisitions<br>Business Development<br>Objectives<br> •<br>Build a leading, diversified specialty<br>pharmaceutical company<br> •<br>Create long<br>-<br>term shareholder value<br>1.<br>This financial data was provided by Collegium on Form 10<br>-<br>K filed with the SEC on February 24,<br>2022<br>and on Form 10<br>-<br>Q filed with the SEC on November 3, 2022.<br>2.<br>Adjusted EBITDA is a non<br>-<br>GAAP financial measure. See Non<br>-<br>GAAP Financial Measures on Slide 2.<br>3.<br>Represents Xtampza ER product revenues.<br>4.<br>Represents Nucynta IR, Nucynta ER, Belbuca,<br>Symproic<br>, Elyxyb, and Other product revenues.<br>$277M<br>$118M<br>$190M<br>History of Accretive Acquisitions<br>1<br>Revenue<br> –<br>organic<br>3<br>Revenue<br> –<br>acquisition<br>4<br>17 |
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| 1.<br>This financial data was provided by Collegium in its press release filed with the SEC on January 4, 2023.<br>2.<br>Adjusted operating expenses is a non<br>-<br>GAAP financial measure. See Non<br>-<br>GAAP Financial Measures on Slide 2.<br>3.<br>Adjusted EBITDA is a non<br>-<br>GAAP financial measure. See Non<br>-<br>GAAP Financial Measures on Slide 2.<br>18<br>2023 Financial Guidance<br>1<br>Product Revenues, Net<br>Adjusted Operating<br>Expenses<br>2<br>(Excluding Stock<br>-<br>Based<br>Compensation)<br>Adjusted EBITDA<br>3<br>(Excluding Stock<br>-<br>Based<br>Compensation)<br>$565<br> –<br>580M<br>$135<br> –<br>145M<br>$355<br> –<br>370M |
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| 19<br>Experienced Management Team and Board of Directors<br>Colleen Tupper<br>EVP & Chief Financial Officer<br>Joseph Ciaffoni<br>President, CEO &<br>Board Member<br>Thomas Smith, M.D.,<br>FAAFP<br>EVP & Chief Medical Officer<br>Scott Dreyer<br>EVP & Chief<br>Commercial Officer<br>Scott Sudduth<br>EVP & Head of<br>Technical Operations<br>Shirley Kuhlmann<br>EVP, General Counsel &<br>Chief Administrative Officer<br>Bart Dunn<br>EVP, Strategy &<br>Corporate Development<br>Kelly Clements<br>VP, Chief People Officer<br>Collegium Board of Directors<br>Joseph Ciaffoni<br>President & CEO,<br>Collegium Pharmaceutical<br>Michael Heffernan<br>Chairman of the Board &<br>Collegium Founder<br>Garen Bohlin<br>Former COO, Sirtris,<br>Former CEO, Syntonix<br>John Freund, M.D.<br>Co<br>-<br>Founder & Partner,<br>Skyline Ventures<br>Gwen Melincoff<br>Former Senior BD roles, BTG<br>International, Shire, Adolor<br>John Fallon, M.D.<br>Former SVP & CMO,<br>Blue Cross Blue Shield of MA<br>Gino Santini<br>Former SVP, Corp. Strategy & BD,<br>President, Eli Lilly<br>Rita Balice<br>-<br>Gordon<br>Chief Executive Officer,<br>Muna Therapeutics<br>Neil McFarlane<br>Former CEO,<br>Adamas Pharmaceuticals |
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| 20<br>Building a Leading, Diversified Specialty Pharmaceutical Company<br>Strong Financial<br>Position<br> •<br>Durable revenue with<br>targeted growth<br>opportunities<br> •<br>Positioned to grow adjusted<br>EBITDA at >1.5x revenue and<br> >4x adjusted operating<br>expenses in 2023<br>1<br> •<br>Strong, growing cash<br>generation<br> •<br>Healthy balance sheet<br>Disciplined Capital<br>Allocation<br> •<br>Focused business<br>development strategy<br> •<br>Rapid debt pay<br>-<br>down<br> •<br>Share repurchase plan<br>available to opportunistically<br>return capital to<br>shareholders<br>Leading<br>Commercial<br>Portfolio<br> •<br>Leader in responsible pain<br>management<br> •<br>Differentiated and distinctly<br>positioned pain portfolio<br>spanning the continuum of<br>care<br> •<br>Anchored by two growth<br>drivers, Belbuca and Xtampza<br>ER, with Nucynta Franchise<br>and<br>Symproic<br>as significant<br>contributors<br>Investment Highlights<br> —<br>Our Path to Long<br>-<br>term Value Creation<br>1.<br>A<br>djusted<br>EBITDA and adjusted operating<br>e<br>xpenses<br>are non<br>-<br>GAAP financial measures.<br>See Non<br>-<br>GAAP Financial Measures on Slide 2. Adjusted EBITDA to revenue and adjusted EBITDA to adjusted<br>operating expenses are calculated based on the mid<br>-<br>point of the 2022 guidance ranges provided by Collegium in its press release<br>filed with the SEC on November 3, 2022 compared to the mid<br>-<br>point<br>of the 2023 guidance ranges provided by Collegium in its press release filed with the SEC on January 4, 2023. |
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| Important Safety Information |
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| See full prescribing information, including Boxed Warning on Addiction, Abuse and Misuse, and other serious risks at<br>XtampzaER.com/PI<br>..<br>22<br>Important Safety Information about XTAMPZA ER<br>(oxycodone) extended<br>-<br>release capsules<br>WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE<br>-<br>THREATENING RESPIRATORY DEPRESSION;<br>ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; and RISKS FROM CONCOMITANT USE<br>WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS<br>Addiction, Abuse, and Misuse<br>Xtampza ER exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose a<br>nd<br>death. Assess each patient’s risk<br>prior to prescribing Xtampza ER and monitor all patients regularly for the development of these behaviors or conditions.<br>Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)<br>To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Admini<br>str<br>ation (FDA) has required a REMS for<br>these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS<br>-<br>compli<br>ant education programs<br>available to healthcare providers. Healthcare providers are strongly encouraged to:<br> •<br>C<br>omplete a REMS<br>-<br>compliant education program<br> •<br>C<br>ounsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these<br>pro<br>ducts<br> •<br>E<br>mphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their p<br>har<br>macist, and<br> •<br>C<br>onsider other tools to improve patient, household, and community safety<br>Life<br>-<br>Threatening Respiratory Depression<br>Serious, life<br>-<br>threatening, or fatal respiratory depression may occur with use of Xtampza ER. Monitor for respiratory depression,<br>especially during initiation of Xtampza<br>ER or following a dose increase.<br>XTAMPZA ER<br>(Oxycodone) extended<br>-<br>release capsules |
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| See full prescribing information, including Boxed Warning on Addiction, Abuse and Misuse, and other serious risks at<br>XtampzaER.com/PI<br>..<br>23<br>Important Safety Information about XTAMPZA ER<br>(oxycodone) extended<br>-<br>release capsules<br>Accidental Ingestion<br>Accidental ingestion of even one dose of Xtampza ER, especially by children, can result in a fatal overdose of Oxycodone.<br>Neonatal Opioid Withdrawal Syndrome<br>Prolonged use of Xtampza ER during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life<br>-<br>threatening if<br>not recognized and treated, and<br>requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period<br>in<br>a pregnant woman, advise the<br>patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.<br>Cytochrome P450 3A4 Interaction<br>The concomitant use of Xtampza ER with all cytochrome P450 3A4 inhibitors may result in an increase in Oxycodone plasma conce<br>ntr<br>ations, which could increase or<br>prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concom<br>ita<br>ntly used cytochrome P450 3A4<br>inducer may result in an increase in Oxycodone plasma concentration. Monitor patients receiving Xtampza ER and any CYP3A4 inh<br>ibi<br>tor or inducer.<br>Risks From Concomitant Use With Benzodiazepines or Other CNS Depressants<br>Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may res<br>ult<br>in profound sedation, respiratory<br>depression, coma, and death.<br> •<br>C<br>omplete a RE<br>Reserve concomitant prescribing of Xtampza ER and benzodiazepines or other CNS depressants for use in patients for whom alter<br>nat<br>ive treatment<br>options are inadequate<br> •<br>Limit dosages and durations to the minimum required<br> •<br>Follow patients for signs and symptoms of respiratory depression and sedation<br>XTAMPZA ER<br>(Oxycodone) extended<br>-<br>release capsules |
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| See full prescribing information, including Boxed Warning on Addiction, Abuse and Misuse, and Other Serious Risks at<br>Belbuca.com/#isi<br>-<br>block<br>..<br>24<br>Important Safety Information about BELBUCA<br>(buprenorphine buccal film)<br>WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE<br>-<br>THREATENING RESPIRATORY DEPRESSION;<br>ACCIDENTAL EXPOSURE; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES AND OTHER<br>CNS DEPRESSANTS<br>Addiction, Abuse, and Misuse<br>BELBUCA exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and<br>dea<br>th. Assess each patient’s risk prior<br>to prescribing BELBUCA and monitor regularly for these behaviors and conditions.<br>Risk Evaluation and Mitigation Strategy (REMS)<br>To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the FDA has required a R<br>EMS<br>for these products. Under the<br>requirements of the REMS, drug companies with approved opioid analgesic products must make REMS<br>-<br>compliant education programs ava<br>ilable to healthcare<br>providers. Healthcare providers are strongly encouraged to<br> •<br>Complete a REMS<br>-<br>compliant education program,<br> •<br>Counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these<br>pr<br>oducts,<br> •<br>Emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their<br>pha<br>rmacist, and<br> •<br>Consider other tools to improve patient, household, and community safety<br>Life<br>-<br>Threatening Respiratory Depression<br>Serious, life<br>-<br>threatening, or fatal respiratory depression may occur with use of BELBUCA. Monitor for respiratory depression, es<br>pecially during initiation of BELBUCA or<br>following a dose increase. Misuse or abuse of BELBUCA by chewing, swallowing, snorting, or injecting Buprenorphine extracted<br>fro<br>m the buccal film will result in the<br>uncontrolled delivery of Buprenorphine and poses a significant risk of overdose and death.<br>Accidental Exposure<br>Accidental exposure to even one dose of BELBUCA, especially in children, can result in a fatal overdose of Buprenorphine.<br>BELBUCA<br>(buprenorphine buccal<br>film) |
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| See full prescribing information, including Boxed Warning on Addiction, Abuse and Misuse, and Other Serious Risks at<br>Belbuca.com/#isi<br>-<br>block<br>..<br>25<br>Important Safety Information about BELBUCA<br>(buprenorphine buccal film)<br>Neonatal Opioid Withdrawal Syndrome<br>Prolonged use of BELBUCA during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life<br>-<br>threatening if no<br>t recognized and treated. If<br>prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome a<br>nd<br>ensure that appropriate treatment<br>will be available.<br>Risks from Concomitant Use with Benzodiazepines Or Other CNS Depressants<br>Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may res<br>ult<br>in profound sedation, respiratory<br>depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are i<br>nad<br>equate; limit dosages and<br>durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation.<br>BELBUCA<br>(buprenorphine buccal<br>film) |
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| See full prescribing information, including Boxed Warning on Addiction, Abuse and Misuse, and other serious risks at<br>Nucynta.com/erPI<br>..<br>26<br>Important Safety Information about NUCYNTA ER<br>(tapentadol) extended<br>-<br>release tablets<br>WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE<br>-<br>THREATENING RESPIRATORY DEPRESSION;<br>ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTION WITH ALCOHOL and RISKS FROM CONCOMITANT USE WITH<br>BENZODIAZEPINES OR OTHER CNS DEPRESSANTS<br>Addiction, Abuse, and Misuse<br>NUCYNTA ER exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose a<br>nd<br>death. Assess each patient’s risk<br>prior to prescribing NUCYNTA ER and monitor all patients regularly for the development of these behaviors and conditions.<br>Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)<br>To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Admini<br>str<br>ation (FDA) has required a REMS for<br>these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS<br>-<br>compli<br>ant education programs<br>available to healthcare providers. Healthcare providers are strongly encouraged to:<br> •<br>Complete a REMS<br>-<br>compliant education program<br> •<br>Counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these<br>pr<br>oducts<br> •<br>Emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their<br>pha<br>rmacist, and<br> •<br>Consider other tools to improve patient, household, and community safety<br>Life<br>-<br>Threatening Respiratory Depression<br>Serious, life<br>-<br>threatening, or fatal respiratory depression may occur with use of NUCYNTA ER. Monitor for respiratory depression,<br>especially during initiation of<br>NUCYNTA ER or following a dose increase. Instruct patients to swallow NUCYNTA ER tablets whole; crushing, chewing, or dissolv<br>ing<br>NUCYNTA ER tablets can cause<br>rapid release and absorption of a potentially fatal dose of Tapentadol.<br>Accidental Ingestion<br>Accidental ingestion of even one dose of NUCYNTA ER, especially by children, can result in a fatal overdose of Tapentadol.<br>NUCYNTA ER<br>(tapentadol) extended<br>-<br>release tablets |
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| See full prescribing information, including Boxed Warning on Addiction, Abuse and Misuse, and other serious risks at<br>Nucynta.com/<br>erPI<br>..<br>27<br>Important Safety Information about NUCYNTA ER<br>(tapentadol) extended<br>-<br>release tablets<br>Neonatal Opioid Withdrawal Syndrome<br>Prolonged use of NUCYNTA ER during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life<br>-<br>threatening if<br>not recognized and treated,<br>and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged pe<br>rio<br>d in a pregnant woman, advise<br>the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.<br>Interaction with Alcohol<br>Instruct patients not to consume alcoholic beverages or use prescription or non<br>-<br>prescription products that contain alcohol while<br>taking NUCYNTA ER. The co<br>-<br>ingestion of alcohol with NUCYNTA ER may result in increased plasma Tapentadol levels and a potentially fatal overdose of Tap<br>ent<br>adol.<br>Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants<br>Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may res<br>ult<br>in profound sedation, respiratory<br>depression, coma, and death<br> •<br>Reserve concomitant prescribing of NUCYNTA ER and benzodiazepines or other CNS depressants for use in patients for whom alter<br>nat<br>ive treatment options are<br>inadequate<br> •<br>Limit dosages and durations to the minimum required<br> •<br>Follow patients for signs and symptoms of respiratory depression and sedation<br>NUCYNTA ER<br>(tapentadol) extended<br>-<br>release tablets |
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| See full prescribing information, including Boxed Warning on Addiction, Abuse and Misuse and other serious risks at<br>Nucynta.com/<br>irPI<br>..<br>28<br>Important Safety Information about NUCYNTA<br>(Tapentadol) tablets<br>WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE<br>-<br>THREATENING RESPIRATORY DEPRESSION;<br>ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS<br>DEPRESSANTS<br>Addiction, Abuse, and Misuse<br>NUCYNTA tablets expose patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdo<br>se<br>and death. Assess each patient’s<br>risk prior to prescribing NUCYNTA tablets and monitor all patients regularly for the development of these behaviors and condi<br>tio<br>ns.<br>Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)<br>To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Admini<br>str<br>ation (FDA) has required a REMS for<br>these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS<br>-<br>compli<br>ant education programs<br>available to healthcare providers. Healthcare providers are strongly encouraged to:<br> •<br>Complete a REMS<br>-<br>compliant education program<br> •<br>Counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these<br>pr<br>oducts<br> •<br>Emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their<br>pha<br>rmacist, and<br> •<br>Consider other tools to improve patient, household, and community safety<br>Life<br>-<br>Threatening Respiratory Depression<br>Serious, life<br>-<br>threatening, or fatal respiratory depression may occur with use of NUCYNTA tablets. Monitor for respiratory depres<br>sion, especially during initiation of<br>NUCYNTA tablets or following a dose increase.<br>Accidental Ingestion<br>Accidental ingestion of even one dose of NUCYNTA tablets, especially by children, can result in a fatal overdose of Tapentado<br>l.<br>NUCYNTA<br>(tapentadol) tablets |
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| See full prescribing information, including Boxed Warning on Addiction, Abuse and Misuse and other serious risks at<br>Nucynta.com/<br>irPI<br>..<br>29<br>Important Safety Information about NUCYNTA<br>(Tapentadol) tablets<br>Neonatal Opioid Withdrawal Syndrome<br>Prolonged use of NUCYNTA tablets during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life<br>-<br>threateni<br>ng if not recognized and<br>treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a pro<br>lon<br>ged period in a pregnant woman,<br>advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available<br>..<br>Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants<br>Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may res<br>ult<br>in profound sedation, respiratory<br>depression, coma, and death.<br> •<br>Reserve concomitant prescribing of NUCYNTA tablets and benzodiazepines or other CNS depressants for use in patients for whom<br>alt<br>ernative treatment options<br>are inadequate<br> •<br>Limit dosages and durations to the minimum required<br> •<br>Follow patients for signs and symptoms of respiratory depression and sedation<br>NUCYNTA<br>(tapentadol) tablets |
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| See<br>full prescribing<br>Information and other<br>s<br>erious risks at<br>Symproic.com/#isi<br>..<br>30<br>Important Safety Information about SYMPROIC<br>(<br>naldemedine<br>) tablets<br>SYMPROIC may cause serious side effects, including:<br> •<br>Tear in your stomach or intestinal wall (perforation). Stomach pain that is severe can be a sign of a serious medical conditi<br>on.<br>If you get stomach pain that does<br>not go away, stop taking SYMPROIC and get emergency medical help right away<br> •<br>Opioid withdrawal. You may have symptoms of opioid withdrawal during treatment with SYMPROIC including sweating, chills, tear<br>ing<br>, warm or hot feeling to your<br>face (flush), sneezing, fever, feeling cold, abdominal pain, diarrhea, nausea, and vomiting. Tell your healthcare provider if<br>yo<br>u have any of these symptoms<br>Do not take SYMPROIC if you:<br> •<br>Have a bowel blockage (intestinal obstruction) or have a history of bowel blockage<br> •<br>Are allergic to SYMPROIC or any of the ingredients in SYMPROIC. See the Medication Guide for a complete list of ingredients i<br>n S<br>YMPROIC. Tell your healthcare<br>provider or pharmacist before you start or stop any medicines during treatment with SYMPROIC<br>Before you take SYMPROIC, tell your healthcare provider about all of your medical conditions, including if you:<br> •<br>Have any stomach or bowel (intestines) problems, including stomach ulcer, Crohn’s disease, diverticulitis, cancer of the stom<br>ach<br>or bowel, or Ogilvie’s syndrome<br> •<br>Have liver problems<br> •<br>Are pregnant or plan to become pregnant. Taking SYMPROIC during pregnancy may cause opioid withdrawal symptoms in your unborn<br>ba<br>by. Tell your healthcare<br>provider right away if you become pregnant during treatment with SYMPROIC<br> •<br>Are breastfeeding or plan to breastfeed. It is not known if SYMPROIC passes into your breast milk. You should not breastfeed<br>dur<br>ing treatment with SYMPROIC<br>and for 3 days after your last dose. Taking SYMPROIC while you are breastfeeding may cause opioid withdrawal symptoms in your<br>ba<br>by. You and your healthcare<br>provider should decide if you will take SYMPROIC or breastfeed. You should not do both<br> •<br>The most common side effects of SYMPROIC include stomach (abdomen) pain, diarrhea, nausea and vomiting (gastroenteritis)<br> •<br>Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the po<br>ssi<br>ble side effects of SYMPROIC. Call<br>your doctor for medical advice about side effects. You may report side effects to FDA at 1<br>-<br>800<br>-<br>FDA<br>-<br>1088<br>SYMPROIC<br>(<br>naldemedine<br>) tablets |
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| See<br>full prescribing<br>Information and other<br>s<br>erious risks at<br>Symproic.com/#isi<br>..<br>31<br>Important Safety Information about SYMPROIC<br>(<br>naldemedine<br>) tablets<br>INDICATIONS AND USAGE<br>SYMPROIC is indicated for the treatment of opioid<br>-<br>induced constipation (OIC) in adult patients with chronic non<br>-<br>cancer pain, inc<br>luding patients with chronic pain related to prior cancer or its<br>treatment who do not require frequent (e.g., weekly) opioid dosage escalation.<br>CONTRAINDICATIONS<br>SYMPROIC is contraindicated in:<br> •<br>Patients with known or suspected gastrointestinal obstruction and patients at increased risk of recurrent obstruction, due to<br>th<br>e potential for gastrointestinal perforation<br> •<br>Patients with a history of a hypersensitivity reaction to<br>Naldemedine<br>.. Reactions have included bronchospasm and rash<br>WARNINGS AND PRECAUTIONS<br>Gastrointestinal Perforation:<br>Cases of gastrointestinal perforation have been reported with use of another peripherally acting opioid antagonist in patient<br>s w<br>ith conditions that may be associated<br>with localized or diffuse reduction of structural integrity in the wall of the gastrointestinal tract (e.g., peptic ulcer dis<br>eas<br>e, Ogilvie’s syndrome, diverticular disease, infiltrative gastrointestinal tract<br>malignancies, or peritoneal metastases). Take into account the overall risk<br>-<br>benefit profile when using SYMPROIC in patients with<br>these conditions or other conditions which might result in impaired<br>integrity of the gastrointestinal tract wall (e.g., Crohn’s disease). Monitor for the development of severe, persistent, or w<br>ors<br>ening abdominal pain; discontinue SYMPROIC in patients who develop this<br>symptom.<br>Opioid Withdrawal:<br>Clusters of symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, increased lacrimation, hot flush/flu<br>shi<br>ng, pyrexia, sneezing, feeling cold, abdominal pain,<br>diarrhea, nausea, and vomiting have occurred in patients treated with SYMPROIC. Patients having disruptions to the blood<br>-<br>brain b<br>arrier may be at increased risk for opioid withdrawal or reduced<br>analgesia. Take into account the overall risk<br>-<br>benefit profile and monitor for symptoms of opioid withdrawal when using SYMPROIC<br>in such patients.<br>ADVERSE REACTIONS<br> •<br>The most common adverse reactions with SYMPROIC compared to placebo in two pooled 12<br>-<br>week studies were: abdominal pain (8% vs 2%<br>), diarrhea (7% vs 2%), nausea (4% vs<br>2%), and gastroenteritis (2% vs 1%).<br> •<br>The incidence of adverse reactions of opioid withdrawal in two pooled 12<br>-<br>week studies was 1% (8/542) for SYMPROIC and 1% (3/546)<br>for placebo. In a 52<br>-<br>week study, the<br>incidence was 3% (20/621) for SYMPROIC and 1% (9/619) for placebo.<br>OVERDOSAGE<br>Single doses of<br>Naldemedine<br>up to 100 mg (500 times the recommended dose) and multiple doses of up to 30 mg (150 times the recommended dose) for 10 days<br>ha<br>ve been administered to healthy<br>subjects in clinical studies. Dose<br>-<br>dependent increases in gastrointestinal<br>-<br>related adverse reactions, including abdominal pain,<br>diarrhea, and nausea, were observed. Single doses of<br>Naldemedine<br>up to<br>3 mg (15 times the recommended dose) and multiple doses of 0.4 mg (twice the recommended dose) for 28 days have been administ<br>ere<br>d to patients with OIC in clinical studies. Dose dependent<br>increases in gastrointestinal<br>-<br>related adverse reactions, including abdominal pain, diarrhea, nausea, and vomiting, were observed<br>.. Also, chills, hyperhidrosis, and dizziness were reported more<br>frequently at 1 and 3 mg doses and hyperhidrosis at the 0.4 mg dose. No antidote for<br>Naldemedine<br>is known. Hemodialysis is not an effective means to remove<br>Naldemedine<br>from the blood.<br>SYMPROIC<br>(<br>naldemedine<br>) tablets |
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| See<br>full prescribing<br>Information and other<br>s<br>erious risks at<br>Symproic.com/#isi<br>..<br>32<br>Important Safety Information about SYMPROIC<br>(<br>naldemedine<br>) tablets<br>USE<br>IN<br>SPECIFIC<br>POPULATIONS<br>Pregnancy<br>:<br>There<br>are<br>no<br>available<br>data<br>with<br>Naldemedine<br>in<br>pregnant<br>women<br>to<br>inform<br>a<br>drug<br>-<br>associated<br>risk<br>of<br>major<br>birth<br>defects<br>and<br>miscarriage<br>..<br>There<br>is<br>a<br>potential<br>for<br>opioid<br>withdrawal<br>in<br>a<br>fetus<br>when<br>SYMPROIC<br>is<br>used<br>in<br>pregnant<br>women<br>..<br>SYMPROIC<br>should<br>be<br>used<br>during<br>pregnancy<br>only<br>if<br>the<br>potential<br>benefit<br>justifies<br>the<br>potential<br>risk<br>..<br>Fetal/Neonatal Adverse Reactions<br>Naldemedine<br>crosses the placenta and may precipitate opioid withdrawal in a fetus due to the immature fetal blood<br>-<br>brain barrier.<br>Lactation<br>There<br>is<br>no<br>information<br>regarding<br>the<br>presence<br>of<br>Naldemedine<br>in<br>human<br>milk,<br>the<br>effects<br>on<br>the<br>breastfed<br>infant,<br>or<br>the<br>effects<br>on<br>milk<br>production<br>..<br>Because<br>of<br>the<br>potential<br>for<br>serious<br>adverse<br>reactions,<br>including<br>opioid<br>withdrawal<br>in<br>breastfed<br>infants,<br>a<br>decision<br>should<br>be<br>made<br>to<br>discontinue<br>breastfeeding<br>or<br>discontinue<br>the<br>drug,<br>taking<br>into<br>account<br>the<br>importance<br>of<br>the<br>drug<br>to<br>the<br>mother<br>..<br>If<br>drug<br>is<br>discontinued<br>in<br>order<br>to<br>minimize<br>drug<br>exposure<br>to<br>a<br>breastfed<br>infant,<br>advise<br>women<br>that<br>breastfeeding<br>may<br>be<br>resumed<br>3<br>days<br>after<br>the<br>final<br>dose<br>of<br>SYMPROIC<br>..<br>Pediatric<br>Use<br>The<br>safety<br>and<br>effectiveness<br>of<br>SYMPROIC<br>have<br>not<br>been<br>established<br>in<br>pediatric<br>patients<br>..<br>Geriatric<br>Use<br>Of<br>the<br>1163<br>patients<br>exposed<br>to<br>SYMPROIC<br>in<br>clinical<br>studies,<br>183<br>(<br>16<br>%<br>)<br>were<br>65<br>years<br>of<br>age<br>and<br>over,<br>while<br>37<br>(<br>3<br>%<br>)<br>were<br>75<br>years<br>and<br>over<br>..<br>No<br>overall<br>differences<br>in<br>safety<br>or<br>effectiveness<br>between<br>these<br>and<br>younger<br>patients<br>were<br>observed,<br>but<br>greater<br>sensitivity<br>of<br>some<br>older<br>individuals<br>cannot<br>be<br>ruled<br>out<br>..<br>In<br>a<br>population<br>pharmacokinetic<br>analysis,<br>no<br>age<br>-<br>related<br>alterations<br>in<br>the<br>pharmacokinetics<br>of<br>Naldemedine<br>were<br>observed<br>..<br>Hepatic<br>Impairment<br>The<br>effect<br>of<br>severe<br>hepatic<br>impairment<br>(Child<br>-<br>Pugh<br>Class<br>C)<br>on<br>the<br>pharmacokinetics<br>of<br>Naldemedine<br>has<br>not<br>been<br>evaluated<br>..<br>Avoid<br>use<br>of<br>SYMPROIC<br>in<br>patients<br>with<br>severe<br>hepatic<br>impairment<br>..<br>No<br>dose<br>adjustment<br>of<br>SYMPROIC<br>is<br>required<br>in<br>patients<br>with<br>mild<br>or<br>moderate<br>hepatic<br>impairment<br>..<br>SYMPROIC<br>(<br>naldemedine<br>) tablets |
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| Non<br>-<br>GAAP Reconciliations |
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| Collegium Pharmaceutical, Inc.<br>Reconciliation of GAAP Net Income to Adjusted EBITDA<br>(in thousands)<br>(unaudited)<br>34<br>GAAP Net (loss) income<br>$<br>(17,803)<br><br><br>$<br>71,517<br><br><br>Adjustments:<br>Interest expense<br>42,638<br><br><br>21,014<br><br><br>Interest income<br>(20)<br><br><br>(12)<br><br><br>Benefit from income taxes<br>(3,253)<br><br><br>(74,891)<br><br><br>Depreciation<br>1,859<br><br><br>1,736<br><br><br>Amortization<br>93,976<br><br><br>67,181<br><br><br>Stock-based compensation expense<br>17,204<br><br><br>24,255<br><br><br>Acquisition related expenses<br>31,209<br><br><br> —<br><br><br>Recognition of step-up basis in inventory<br>23,760<br><br><br> —<br><br><br>Restructuring<br> —<br><br><br>4,578<br><br><br>Litigation settlements<br> —<br><br><br>2,935<br><br><br>Total adjustments<br>$<br>207,373<br><br><br>$<br>46,796<br><br><br>Adjusted EBITDA<br>$<br>189,570<br><br><br>$<br>118,313<br><br><br>2022<br>2021<br>Nine Months Ended<br>September 30,<br>Year Ended<br>December 31, |
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| Collegium Pharmaceutical, Inc.<br>Reconciliation of GAAP Operating Expenses to Adjusted Operating Expenses<br>(in thousands)<br>(unaudited)<br>35<br>GAAP Operating expenses<br>$<br>138,137<br><br><br>$<br>132,989<br><br><br>Adjustments:<br>Stock-based compensation<br>17,204<br><br><br>24,255<br><br><br>Acquisition related expenses<br>31,209<br><br><br> —<br><br><br>Restructuring<br> —<br><br><br>4,578<br><br><br>Litigation settlements<br> —<br><br><br>2,935<br><br><br>Total adjustments<br>$<br>48,413<br><br><br>$<br>31,768<br><br><br>Adjusted operating expenses<br>$<br>89,724<br><br><br>$<br>101,221<br><br><br>2022<br>2021<br>Nine Months Ended<br>September 30,<br>Year Ended<br>December 31, |
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