Buprenorphine Hydrochloride

– Generated Q1’24 Net Revenue of $144.9 Million – – Delivered Q1’24 Record Belbuca® Revenue of $50.7 Million; Total Prescriptions Up 4.2% Year-over-Year – – Achieved Q1’24 GAAP Net Income of $27.7 Million vs. Q1’23 GAAP Net Loss of $(17.4) Million – – Delivered Q1’24 Adjusted EBITDA of $92.4 Million, Up 5% Year-over-Year – – Board of Directors Authorized $35.0 Million Accelerated Share Repurchase Program – – Reaffirmed Full-Year 2024 Guidance – – Conference Call Scheduled for Today at 4:30 p.m. ET – STOUGHTON, Mass., May 09, 2024 (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 ended March 31, 2024, and provided a corporate update. “Thanks to our dedicated team and successful first quarter, Collegium is progressing towards another year of record financial performance,” said Joe Ciaffoni, President and Chief Executive Officer of Collegium. “Our recently announced authorized generic agreement with Hikma meaningfully improves the value of the Nucynta Franchise, which, combined with our healthy balance sheet, fortifies our financial position and gives us confidence in our ability to create value for our shareholders. I am confident the organization is well positioned to deliver on its financial and capital deployment priorities in 2024 by focusing on operational execution.” “We delivered strong first quarter results marked by record Belbuca revenue, managed expenses and robust cash flows, positioning us to achieve our 2024 financial guidance,” said Colleen Tupper, Chief Financial Officer of Collegium. “Our outlook in 2025 and beyond continues to improve. We are committed to deploying capital to create value for our shareholders as demonstrated by the redemption of the total principal amount of our 2026 convertible notes and our newly announced $35.0 million Accelerated Share Repurchase program.” Business Highlights Grew Belbuca total prescriptions 4.2% in the quarter ended March 31, 2024, compared to the prior year quarter. Belbuca net revenue was a record $50.7 million, up 15% year-over-year.Achieved Xtampza® ER gross-to-net of 53.6% in the quarter ended March 31, 2024. Xtampza ER gross-to-net is expected to be in the range of 56% to 58% for the full-year 2024.Presented four posters at the American Academy of Pain Medicine (AAPM) Annual Meeting in March 2024.In April, called all $26.4 million aggregate principal amount of Collegium’s outstanding 2.625% Convertible Senior Notes due in 2026 for redemption on Friday, June 14, 2024.In April, announced Collegium has entered into an authorized generic agreement with Hikma Pharmaceuticals USA Inc., pursuant to which Hikma will have the exclusive right to sell the authorized generic versions of Nucynta® and Nucynta® ER in the United States.In May, announced that Joe Ciaffoni will step down as President and Chief Executive Officer (CEO) of the Company effective May 24, 2024. Mr. Ciaffoni will serve as a member of the Board of Directors of the Company until the upcoming 2024 Annual Meeting of Shareholders and will not stand for re-election at the meeting. To ensure a seamless transition, Michael Heffernan, founder, former CEO and Chairman of the Board will serve as Interim President and CEO until a new CEO is appointed by the Board of Directors.Board of Directors authorized a $35.0 million Accelerated Share Repurchase program. Financial Guidance for 2024 The Company reaffirms its full-year 2024 guidance for Product Revenues, Net, Adjusted Operating Expenses and Adjusted EBITDA: Product Revenues, Net$580.0 to $595.0 millionAdjusted Operating Expenses(Excluding Stock-Based Compensation)$120.0 to $125.0 millionAdjusted EBITDA(Excluding Stock-Based Compensation)$380.0 to $395.0 million Financial Results for Quarter Ended March 31, 2024 Product revenues, net were $144.9 million for the quarter ended March 31, 2024 (the 2024 Quarter), compared to $144.8 million for the quarter ended March 31, 2023 (the 2023 Quarter), relatively flat year-over-year.GAAP operating expenses were $42.0 million for the 2024 Quarter, compared to $52.8 million for the 2023 Quarter, representing a 20% decrease year-over-year. Adjusted operating expenses, which exclude stock-based compensation expense and other adjustments to reflect changes that occur in our business but do not represent ongoing operations, were $34.5 million for the 2024 Quarter, compared to $38.2 million for the 2023 Quarter, representing a 10% decrease year-over-year.GAAP net income for the 2024 Quarter was $27.7 million, with $0.86 GAAP earnings per share (basic) and $0.71 GAAP earnings per share (diluted), compared to GAAP net loss for the 2023 Quarter of $(17.4) million, with $(0.51) GAAP loss per share (basic and diluted). Non-GAAP adjusted net income for the 2024 Quarter was $58.8 million, with $1.45 adjusted earnings per share, compared to non-GAAP adjusted net income for the 2023 Quarter of $51.7 million, with $1.32 adjusted earnings per share.Adjusted EBITDA for the 2024 Quarter was $92.4 million, compared to $87.6 million for the 2023 Quarter, representing a 5% increase year-over-year.The Company exited the 2024 Quarter with cash, cash equivalents and marketable securities of $318.0 million, up from $310.5 million as of December 31, 2023. Conference Call Information The Company will host a conference call and live audio webcast on Thursday, May 9, 2024, at 4:30 p.m. ET. To access the conference call, please dial (877) 407-8037 (U.S.) or (201) 689-8037 (International) and reference the “Collegium Pharmaceutical Q1 2024 Earnings Call.” An audio webcast will be accessible from the Investors section of the Company’s website: www.collegiumpharma.com. The webcast will be available for replay on the Company’s website approximately two hours after the event. About Collegium Pharmaceutical, Inc. Collegium is a leading, diversified specialty pharmaceutical company committed to improving the lives of people living with serious medical conditions. Collegium’s headquarters are located in Stoughton, Massachusetts. For more information, please visit the Company’s website at www.collegiumpharma.com. Non-GAAP Financial Measures To supplement our financial results presented on a GAAP basis, we have included information about certain non-GAAP financial measures. We believe the presentation of these non-GAAP financial measures, when viewed with our results under GAAP and the accompanying reconciliations, provide analysts, investors, lenders, and other third parties with insights into how we evaluate normal operational activities, including our ability to generate cash from operations, on a comparable year-over-year basis and manage our budgeting and forecasting. In addition, certain non-GAAP financial measures, primarily Adjusted EBITDA, are used to measure performance when determining components of annual compensation for substantially all non-sales force employees, including senior management. In our quarterly and annual reports, earnings press releases and conference calls, we may discuss the following financial measures that are not calculated in accordance with GAAP, to supplement our consolidated financial statements presented on a GAAP basis. Adjusted EBITDA Adjusted EBITDA is a non-GAAP financial measure that represents GAAP net income or loss adjusted to exclude interest expense, interest income, the benefit from or provision for income taxes, depreciation, amortization, stock-based compensation, and other adjustments to reflect changes that occur in our business but do not represent ongoing operations. Adjusted EBITDA, as used by us, may be calculated differently from, and therefore may not be comparable to, similarly titled measures used by other companies. There are several limitations related to the use of adjusted EBITDA rather than net income or loss, which is the nearest GAAP equivalent, such as: adjusted EBITDA excludes depreciation and amortization, and, although these are non-cash expenses, the assets being depreciated or amortized may have to be replaced in the future, the cash requirements for which are not reflected in adjusted EBITDA;we exclude stock-based compensation expense from adjusted EBITDA although: (i) it has been, and will continue to be for the foreseeable future, a significant recurring expense for our business and an important part of our compensation strategy; and (ii) if we did not pay out a portion of our compensation in the form of stock-based compensation, the cash salary expense included in operating expenses would be higher, which would affect our cash position;adjusted EBITDA does not reflect changes in, or cash requirements for, working capital needs;adjusted EBITDA does not reflect the benefit from or provision for income taxes or the cash requirements to pay taxes;adjusted EBITDA does not reflect historical cash expenditures or future requirements for capital expenditures or contractual commitments;we exclude impairment expenses from adjusted EBITDA and, although these are non-cash expenses, the asset(s) being impaired may have to be replaced in the future, the cash requirements for which are not reflected in adjusted EBITDA;we exclude restructuring expenses from adjusted EBITDA. Restructuring expenses primarily include employee severance and contract termination costs that are not related to acquisitions. The amount and/or frequency of these restructuring expenses are not part of our underlying business;we exclude litigation settlements from adjusted EBITDA, as well as any applicable income items or credit adjustments due to subsequent changes in estimates. This does not include our legal fees to defend claims, which are expensed as incurred;we exclude acquisition related expenses as the amount and/or frequency of these expenses are not part of our underlying business. Acquisition related expenses include transaction costs, which primarily consisted of financial advisory, banking, legal, and regulatory fees, and other consulting fees, incurred to complete the acquisition, employee-related expenses (severance cost and benefits) for terminated employees after the acquisition, and miscellaneous other acquisition related expenses incurred;we exclude recognition of the step-up basis in inventory from acquisitions (i.e., the adjustment to record inventory from historic cost to fair value at acquisition) as the adjustment does not reflect the ongoing expense associated with sale of our products as part of our underlying business; andwe exclude losses on extinguishments of debt as these expenses are episodic in nature and do not directly correlate to the cost of operating our business on an ongoing basis. Adjusted Operating Expenses Adjusted operating expenses is a non-GAAP financial measure that represents GAAP operating expenses adjusted to exclude stock-based compensation expense, and other adjustments to reflect changes that occur in our business but do not represent ongoing operations. Adjusted Net Income and Adjusted Earnings Per Share Adjusted net income is a non-GAAP financial measure that represents GAAP net income or loss adjusted to exclude significant income and expense items that are non-cash or not indicative of ongoing operations, including consideration of the tax effect of the adjustments. Adjusted earnings per share is a non-GAAP financial measure that represents adjusted net income per share. Adjusted weighted-average shares - diluted is calculated in accordance with the treasury stock, if-converted, or contingently issuable accounting methods, depending on the nature of the security. Reconciliations of adjusted EBITDA, adjusted operating expenses, adjusted net income, and adjusted earnings per share to the most directly comparable GAAP financial measures are included in this press release. The Company has not provided a reconciliation of its full-year 2024 guidance for adjusted EBITDA or adjusted operating expenses to the most directly comparable forward-looking GAAP measures, in reliance on the unreasonable efforts exception provided under Item 10(e)(1)(i)(B) of Regulation S-K, because the Company is unable to predict, without unreasonable efforts, the timing and amount of items that would be included in such a reconciliation, including, but not limited to, stock-based compensation expense, acquisition related expense and litigation settlements. These items are uncertain and depend on various factors that are outside of the Company’s control or cannot be reasonably predicted. While the Company is unable to address the probable significance of these items, they could have a material impact on GAAP net income and operating expenses for the guidance period. A reconciliation of adjusted EBITDA or adjusted operating expenses would imply a degree of precision and certainty as to these future items that does not exist and could be confusing to investors. Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as "predicts," "forecasts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Examples of forward-looking statements contained in this press release include, among others, statements related to our full-year 2024 financial guidance, including projected product revenue, adjusted operating expenses and adjusted EBITDA, current and future market opportunities for our products and our assumptions related thereto, expectations (financial or otherwise) and intentions, and other statements that are not historical facts. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results, performance, or achievements to differ materially from the company's current expectations, including risks relating to, among others: unknown liabilities; risks related to future opportunities and plans for our products, including uncertainty of the expected financial performance of such products; our ability to commercialize and grow sales of our products; our ability to manage our relationships with licensors; the success of competing products that are or become available; our ability to maintain regulatory approval of our products, and any related restrictions, limitations, and/or warnings in the label of our products; the size of the markets for our products, and our ability to service those markets; our ability to obtain reimbursement and third-party payor contracts for our products; the rate and degree of market acceptance of our products; the costs of commercialization activities, including marketing, sales and distribution; changing market conditions for our products; the outcome of any patent infringement or other litigation that may be brought by or against us; the outcome of any governmental investigation related to our business; our ability to secure adequate supplies of active pharmaceutical ingredient for each of our products and manufacture adequate supplies of commercially saleable inventory; our ability to obtain funding for our operations and business development; regulatory developments in the U.S.; our expectations regarding our ability to obtain and maintain sufficient intellectual property protection for our products; our ability to comply with stringent U.S. and foreign government regulation in the manufacture of pharmaceutical products, including U.S. Drug Enforcement Agency, or DEA, compliance; our customer concentration; and the accuracy of our estimates regarding expenses, revenue, capital requirements and need for additional financing. These and other risks are described under the heading "Risk Factors" in our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and other filings with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release. Investor Contact:Christopher James, M.D.Vice President, Investor Relationsir@collegiumpharma.com Media Contact:Marissa SamuelsVice President, Corporate Communicationscommunications@collegiumpharma.com Collegium Pharmaceutical, Inc. Unaudited Selected Consolidated Balance Sheet Information(in thousands) March 31, December 31, 2024 2023Cash and cash equivalents $228,610 $238,947Marketable securities 89,438 71,601Accounts receivable, net 174,693 179,525Inventory 31,276 32,332Prepaid expenses and other current assets 15,243 15,195Property and equipment, net 15,457 15,983Operating lease assets 5,813 6,029Intangible assets, net 387,191 421,708Restricted cash 1,047 1,047Deferred tax assets 30,671 26,259Other noncurrent assets 954 825Goodwill 133,857 133,857Total assets $1,114,250 $1,143,308 Accounts payable and accrued liabilities 44,210 46,263Accrued rebates, returns and discounts 217,880 227,331Term notes payable 360,693 405,046Convertible senior notes 262,425 262,125Operating lease liabilities 6,873 7,112Shareholders’ equity 222,169 195,431Total liabilities and stockholders’ equity $1,114,250 $1,143,308 Collegium Pharmaceutical, Inc. Unaudited Condensed Statements of Operations(in thousands, except share and per share amounts) Three Months Ended March 31, 2024 2023Product revenues, net$144,923 $144,767 Cost of product revenues Cost of product revenues (excluding intangible asset amortization) 18,950 29,899 Intangible asset amortization 34,517 37,466 Total cost of product revenues 53,467 67,365 Gross profit 91,456 77,402 Operating expenses Selling, general and administrative 41,982 52,775 Total operating expenses 41,982 52,775 Income from operations 49,474 24,627 Interest expense (17,339) (21,427)Interest income 4,487 2,747 Loss on extinguishment of debt — (23,504)Income (loss) before income taxes 36,622 (17,557)Provision for (benefit from) income taxes 8,909 (131)Net income (loss)$27,713 $(17,426) Earnings (loss) per share — basic$0.86 $(0.51)Weighted-average shares — basic 32,326,589 34,319,291 Earnings (loss) per share — diluted$0.71 $(0.51)Weighted-average shares — diluted 41,438,466 34,319,291 Collegium Pharmaceutical, Inc. Reconciliation of GAAP Net Income (Loss) to Adjusted EBITDA(in thousands)(unaudited) Three Months Ended March 31, 2024 2023GAAP net income (loss)$27,713 $(17,426)Adjustments: Interest expense 17,339 21,427 Interest income (4,487) (2,747)Loss on extinguishment of debt — 23,504 Provision for (benefit from) income taxes 8,909 (131)Depreciation 917 817 Amortization 34,517 37,466 Stock-based compensation 7,475 6,035 Litigation settlements — 8,500 Recognition of step-up basis in inventory — 10,170 Total adjustments$64,670 $105,041 Adjusted EBITDA$92,383 $87,615 Collegium Pharmaceutical, Inc. Reconciliation of GAAP Operating Expenses to Adjusted Operating Expenses(in thousands)(unaudited) Three Months Ended March 31, 2024 2023GAAP operating expenses$41,982 $52,775Adjustments: Stock-based compensation 7,475 6,035Litigation settlements — 8,500Total adjustments$7,475 $14,535Adjusted operating expenses$34,507 $38,240 Collegium Pharmaceutical, Inc. Reconciliation of GAAP Net Income (Loss) to Adjusted Net Income and Adjusted Earnings Per Share(in thousands, except share and per share amounts)(unaudited) Three Months Ended March 31, 2024 2023GAAP net income (loss)$27,713 $(17,426)Adjustments: Non-cash interest expense 1,780 2,287 Loss on extinguishment of debt — 23,504 Amortization 34,517 37,466 Stock-based compensation 7,475 6,035 Litigation settlements — 8,500 Recognition of step-up basis in inventory — 10,170 Income tax effect of above adjustments (1) (12,653) (18,874)Total adjustments$31,119 $69,088 Non-GAAP adjusted net income$58,832 $51,662 Adjusted weighted-average shares — diluted (2) 41,438,466 40,196,015 Adjusted earnings per share (2)$1.45 $1.32 (1) The income tax effect of the adjustments was calculated by applying our blended federal and state statutory rate to the items that have a tax effect. The blended federal and state statutory rate for the three months ended March 31, 2024 and 2023 were 26.6% and 26.8%, respectively. As such, the non-GAAP effective tax rates for the three months ended March 31, 2024 and 2023 were 28.9% and 21.5%, respectively.(2) Adjusted weighted-average shares - diluted were calculated using the “if-converted” method for our convertible notes in accordance with ASC 260, Earnings per Share. As such, adjusted weighted-average shares – diluted includes shares related to the assumed conversion of our convertible notes and the associated cash interest expense added-back to non-GAAP adjusted net income. For the three months ended March 31, 2024 and 2023, adjusted weighted-average shares – diluted includes 7,509,104 and 4,646,372 shares, respectively, attributable to our convertible notes. In addition, adjusted earnings per share includes other potentially dilutive securities to the extent that they are not antidilutive.

SAINT LAURENT, Quebec, April 05, 2024 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX:IGX) (OTCQB:IGXT) (the “Company” or “IntelGenx”) today announced that its co-developer, Chemo Research SL, through its agent and affiliate, Xiromed LLC (“Xiromed”), has received a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) regarding its resubmitted abbreviated new drug application (“ANDA”) for Buprenorphine Buccal Film. The CRL includes a request for additional Pharmaceutical Quality information. The FDA confirmed that no additional inspection of IntelGenx’s facility is required at this time. “Our partner is committed to providing the FDA with a response to the CRL as soon as is practicable,” commented Dwight Gorham, IntelGenx’s CEO. Buprenorphine Buccal Film, which incorporates IntelGenx’s VersaFilm® technology in a novel formulation, is a generic version of Belbuca®, an opioid that is used to manage chronic pain severe enough to require daily, around-the-clock, long-term treatment with an opioid, when other pain treatments are inadequate. Approved by the FDA in 2015, Belbuca® is applied to the oral or buccal mucosa every 12 hours and comes in seven strengths ranging from 0.075 mg to 0.9 mg. About IntelGenx IntelGenx is a leading drug delivery company focused on the development and manufacturing of pharmaceutical films. IntelGenx’s superior film technologies, including VersaFilm®, DisinteQ™, VetaFilm® and transdermal VevaDerm™, allow for next generation pharmaceutical products that address unmet medical needs. IntelGenx’s innovative product pipeline offers significant benefits to patients and physicians for many therapeutic conditions. IntelGenx's highly skilled team provides comprehensive pharmaceuticals services to pharmaceutical partners, including R&D, analytical method development, clinical monitoring, IP and regulatory services. IntelGenx's state-of-the-art manufacturing facility offers full service by providing lab-scale to pilot- and commercial-scale production. For more information, visit . Forward-Looking Information and Statements This document may contain forward-looking information about IntelGenx's operating results and business prospects that involve substantial risks and uncertainties. Statements that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, but are not limited to, statements about IntelGenx's plans, objectives, expectations, strategies, intentions or other characterizations of future events or circumstances and are generally identified by the words "may," "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates," "could," "would," and similar expressions. All forward looking statements are expressly qualified in their entirety by this cautionary statement. Because these forward-looking statements are subject to a number of risks and uncertainties, IntelGenx's actual results could differ materially from those expressed or implied by these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed under the heading "Risk Factors" in IntelGenx's annual report on Form 10-K, filed with the SEC and available at , and also filed with Canadian securities regulatory authorities at . IntelGenx assumes no obligation to update any such forward-looking statements. Source: IntelGenx Technologies Corp. For IntelGenx: Stephen Kilmer Investor Relations (647) 872-4849 stephen@kilmerlucas.com Or Andre Godin, CPA, CA President and CFO IntelGenx Corp. (514) 331-7440 ext 203 andre@intelgenx.com