Clobazam

Delivers FY2025 Net Product Sales and Adjusted EBITDA Above Guidance Expects Net Product Sales between $110M-$125M and Adjusted EBITDA between $28M-$40M in FY2026 LAKE FOREST, Ill--(BUSINESS WIRE)-- Assertio Holdings, Inc. (“Assertio” or the “Company”) (Nasdaq: ASRT), a pharmaceutical company with comprehensive commercial capabilities offering differentiated products designed to address patients’ needs, today reported financial results for the fourth quarter and full year ended December 31, 2025. Mark Reisenauer, Chief Executive Officer, stated: “Our core asset, Rolvedon, continues to represent a meaningful revenue opportunity, as reflected in both our 2025 results and 2026 outlook, and our strong commercial infrastructure and market access capabilities provide a platform to expand and build an oncology portfolio in a disciplined way. Since taking over as CEO, I’ve taken a close look at our business to understand where we have a real advantage and where we need to stay disciplined. That has reinforced our focus on finding products that leverage our existing capabilities rather than pursuing on-market specialty product acquisitions, which we do not view as a sustainable path for long-term growth. Our priorities are clear: leverage our core strengths, allocate capital thoughtfully, and build a differentiated oncology franchise that drives durable shareholder value.” Fourth Quarter 2025 Financial Highlights Rolvedon net product sales were $0.4 million for the fourth quarter of 2025, down from $15.4 million in the prior-year quarter. The expected decline in sales was driven by the sell-in, executed in the third quarter of 2025, which covered the next two quarters of demand to ensure uninterrupted patient supply of Rolvedon as product was transitioned to a new distribution partner and operations were consolidated under a single commercial entity. Rolvedon continues to be a leader in market share in the Medicare Part B clinic space and sales under the new label are expected to begin in the second quarter of 2026. Sympazan net product sales grew to $3.1 million for the fourth quarter of 2025 from $2.5 million in the prior-year quarter, driven by higher volume and favorable payor mix. Indocin net product sales were $5.5 million for both the fourth quarter of 2025 and the prior-year quarter, with volume decline from generic competition offset by higher net pricing. Gross margin1 was 75%, up from 61% in the prior-year quarter, primarily due to the impact of sales product mix as well as inventory write-downs taken in the prior-year quarter. SG&A expenses were $13.1 million, down from $21.4 million in the prior-year quarter, reflecting lower legal expenses following completion of litigation-related initiatives and lower personnel expenses as a result of restructuring activities in the fourth quarter. Adjusted EBITDA2 was a loss of $4.1 million for the fourth quarter of 2025, compared with earnings of $3.4 million in the prior-year quarter, driven primarily by the impact of lower Rolvedon net product sales. Cash, cash equivalents, and short-term investments totaled $63.4 million as of December 31, 2025, compared to $93.4 million as of September 30, 2025 primarily reflecting impacts from the Rolvedon third quarter sell-in. Cash and cash equivalents will be impacted by working capital variability from the Rolvedon sell-in through the first quarter of 2026. Full-Year 2025 Financial Highlights Rolvedon net product sales were $68.2 million for full-year 2025, up from $60.1 million in the prior year. The increase was primarily driven by higher volume, including the third quarter sell-in activity, and a $5.4 million favorable adjustment to prior period returns reserve established in connection with the Spectrum acquisition, partially offset by lower net pricing. Sympazan net product sales grew to $11.3 million for full-year 2025 from $10.5 million in the prior year, driven by higher volume, partially offset by unfavorable payor mix. Indocin net product sales were $18.9 million for full-year 2025, down from $26.8 million in the prior year, reflecting expected volume and pricing impacts from previously announced generic competition. Gross margin was 70% in 2025, up from 68% in the prior year, primarily due to a year-over-year decrease in inventory write-downs, and prior year inventory step-up amortization not repeating. SG&A expenses were $69.0 million for full-year 2025, down from $75.1 million in the prior year, driven by lower legal costs following completion of litigation-related initiatives, a one-time benefit from employee retention tax credits, and lower personnel-related expenses, partially offset by non-recurring Otrexup decommercialization costs. Adjusted EBITDA3 for full-year 2025 was $22.7 million, up from $18.3 million in the prior year, driven primarily by the impacts of lower SG&A expenses and favorable gross margin. Cash, cash equivalents, and short-term investments totaled $63.4 million as of December 31, 2025, compared to $100.1 million as of December 31, 2024, primarily reflecting working capital impacts from the Rolvedon third quarter sell-in and cash transferred with the divestment of Assertio Therapeutics. 2026 Full Year Financial Guidance Assertio announced its initial 2026 operating guidance as follows: Net Product Sales (GAAP) $110.0 Million to $125.0 Million Adjusted EBITDA (Non-GAAP) $28.0 Million to $40.0 Million Financial Highlights (unaudited): Three Months Ended December 31, Year Ended December 31, (in millions, except per share amounts) 2025 2024 2025 2024 Net Product Sales (GAAP) $ 12.8 $ 29.6 $ 117.1 $ 120.8 Net Loss (GAAP) $ (11.9 ) $ (10.5 ) $ (30.4 ) $ (21.6 ) Diluted Net Loss Per Share (GAAP)* $ (1.86 ) $ (1.65 ) $ (4.74 ) $ (3.40 ) Adjusted EBITDA (Non-GAAP)3 $ (4.1 ) $ 3.4 $ 22.7 $ 18.3 Adjusted Earnings Per Share (Non-GAAP)*3 $ (1.06 ) $ 0.01 $ 1.42 $ 0.90 (*) Diluted net loss per share and Adjusted earnings per share for the three months ended December 31, 2024 and the year ended December 31, 2024 have been adjusted to reflect the 1-for-15 reverse stock split effected on December 26, 2025. 1 Gross margin represents the ratio of net product sales less cost of sales to net product sales. 2 See "Non-GAAP financial measures" below for information about reconciling Adjusted EBITDA to Net Loss. 3 Non-GAAP measures are reconciled to the corresponding GAAP measures in the schedules attached. Conference Call and Investor Presentation Information Assertio’s management will host a conference call to discuss its fourth quarter and full year 2025 financial results today: Date: 3/16/2026 Time: 4:30 p.m. Eastern Time Webcast (live and archive): http://investor.assertiotx.com/overview/default.aspx (Events & Webcasts, Investor Page) Dial-in numbers: 1-646-307-1963, Conference ID 3278948 To access the live webcast, the recorded conference call replay, and other materials, please visit Assertio’s investor relations website at http://investor.assertiotx.com/overview/default.aspx. Please connect at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. The replay will be available approximately two hours after the call on Assertio’s investor website. About Assertio Assertio is a pharmaceutical company with comprehensive commercial capabilities offering differentiated products designed to address patients’ needs. Our focus is on supporting patients by marketing products primarily in the oncology market. To learn more about Assertio, visitwww.assertiotx.com. Forward Looking Statements The statements in this communication include forward-looking statements. Forward-looking statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs. Forward-looking statements speak only as of the date they are made or as of the dates indicated in the statements and should not be relied upon as predictions of future events, as there can be no assurance that the events or circumstances reflected in these statements will be achieved or will occur. Forward-looking statements can often, but not always, be identified by the use of forward-looking terminology such as “anticipate,” “approximate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “may,” “might,” “opportunity,” “plan,” “potential,” “project,” “prospective,” “pursue,” “seek,” “should,” “strategy,” “target,” “will,” or the negative of these words and phrases, other variations of these words and phrases or comparable terminology. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the statements, including: Assertio’s ability to grow sales and the commercial success and market acceptance of Rolvedon and Assertio’s other products, including the coverage of Assertio’s products by payors and pharmacy benefit managers; Assertio’s ability to successfully develop and execute its sales, marketing and promotional strategies using its sales force and omni-channel promotion model capabilities; the impact on sales and profits from the entry and sales of generics of Assertio’s products and/or other products competitive with any of Assertio’s products, including, but not limited to, biosimilars and indomethacin suppositories compounded by hospitals and other institutions and a 503B compounder which Assertio believes is violating certain provisions of the Federal Food, Drug and Cosmetic Act; the timing and impact of additional generic approvals and uncertainty around the recent approvals and launches of generic Indocin products, which are not patent protected and now face generic competition; Assertio’s ability to execute the planned simplification of its corporate structure, which includes the recent divestiture of Assertio Therapeutics and ongoing efforts to consolidate operations and align products under a single entity – while ensuring uninterrupted product supply for patients, in a manner that achieves on a timely basis the anticipated operating efficiencies and complies with applicable legal and regulatory requirements; Assertio’s ability to successfully identify and execute business development and other strategic transactions; Assertio’s ability to achieve the expected financial performance from product candidates and/or products we acquire as well as delays, challenges and expenses, and unexpected liabilities and costs associated with obtaining regulatory approval and launching or integrating, as applicable, and operating newly-acquired product candidates and/or products, including its expectations around its ability to grow the sales and profitability of ROLVEDON; expectations regarding changes in product volume and mix and the impact those changes may have on Assertio’s operating results; expectations regarding the recoverability of long-lived assets; expected industry trends, including pricing pressures and managed healthcare practices; Assertio’s ability to retain executive leadership and key employees; the ability of Assertio’s third-party manufacturers to manufacture adequate quantities of commercially salable inventory and active pharmaceutical ingredients for each of Assertio’s products on commercially reasonable terms and in compliance with their contractual obligations to Assertio, and Assertio’s ability to maintain its supply chain which relies on single-source suppliers; the outcome of, and Assertio’s intentions with respect to, any pending and potential future disputes, litigation or government investigations, as well as the costs and expenses associated therewith; the timing, cost and results of Assertio’s clinical studies and other research and development efforts, including the extent to which data from the Rolvedon same-day dosing trial, which was completed in the fourth quarter of 2024 and published in the January 2026 issue of the peer- reviewed journal, The Oncologist, may be subsequently included in the National Comprehensive Cancer Network guidelines to support Assertio’s ongoing commercialization efforts; Assertio’s compliance or non-compliance with, or being subject to, legal and regulatory requirements related to the development or promotion of pharmaceutical products in the U.S., the extent to which the current U.S. federal administration may impose or seek to impose leadership, rule and/or policy changes impacting Assertio’s business, including CMS’s recently proposed new drug payment models to lower drug prices for Medicare beneficiaries under which CMS would explore potential adjustments to Medicare drug inflation rebate calculations by comparison to international drug pricing information, as well as legal challenges and uncertainty around the funding, functioning, regulatory and policy priorities of U.S. federal regulatory agencies; Assertio’s ability to obtain and maintain intellectual property protection for its products and operate its business without infringing the intellectual property rights of others; variations in revenues obtained from commercialization agreements and the accounting treatment with respect thereto; Assertio’s common stock maintaining compliance with The Nasdaq Capital Market’s minimum closing bid requirement of at least $1.00 per share; and the potential impacts of changes to U.S. and international trade policies, especially in light of the tariffs recently announced or imposed by the new U.S. federal administration, including announced plans to impose up to 100% tariffs on imported branded or patented pharmaceuticals subject to certain exceptions, and tariffs and other retaliatory actions, including legal challenges, taken by other countries, which may be followed by further changes to existing trade agreements and the imposition of further tariffs. For a discussion of additional factors that could cause actual results to differ materially from those contemplated by forward-looking statements, see the risks described in Assertio’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Many of these risks and uncertainties may be exacerbated by public health emergencies and general macroeconomic conditions. Assertio does not assume, and hereby disclaims, any obligation to update forward-looking statements, except as may be required by law. Non-GAAP Financial Measures To supplement the Company’s financial results presented on a U.S. generally accepted accounting principles (“GAAP”) basis, the Company has included information about non-GAAP measures of EBITDA, adjusted EBITDA, adjusted earnings, and adjusted earnings per share as useful operating metrics. The Company believes that the presentation of these non-GAAP financial measures, when viewed with results under GAAP and the accompanying reconciliation, provides supplementary information to analysts, investors, lenders, and the Company’s management in assessing the Company’s performance and results from period to period. The Company uses these non-GAAP measures internally to understand, manage and evaluate the Company’s performance, and in part, in the determination of bonuses for executive officers and employees. These non-GAAP financial measures should be considered in addition to, and not a substitute for, or superior to, net income or other financial measures calculated in accordance with GAAP. Non-GAAP financial measures used by us may be calculated differently from, and therefore may not be comparable to, non-GAAP measures used by other companies. Specified Items Non-GAAP measures presented within this release exclude specified items. The Company considers specified items to be significant income/expense items not indicative of current operations. Specified items may include adjustments to interest expense and interest income, income tax expense (benefit), depreciation expense, amortization expense, sales reserves adjustments for products the Company is no longer selling, stock-based compensation expense, fair value adjustments to contingent consideration or derivative liability, expenses or gains recognized for legal settlements, net of any insurance proceeds, losses or other costs incurred upon the divestiture of subsidiaries or cessation of product lines, restructuring charges, amortization of fair value inventory step-up as a result of purchase accounting, transaction-related costs, gains, losses or impairments from adjustments to long-lived assets and assets not part of current operations, changes in valuation allowances on deferred tax assets, and gains or losses resulting from debt refinancing or extinguishment. Revisions to Specified Items Beginning with the first quarter of 2025, adjusted EBITDA excludes legal settlement costs incurred during the period, as these charges relate to non-recurring and non-operational matters. Management believes that excluding such items provides investors with a clearer understanding of the Company’s underlying operating performance by removing the impact of items that are not indicative of continuing operations. Prior period amounts of Adjusted EBITDA have been recast to conform to this presentation. ASSERTIO HOLDINGS, INC. CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (in thousands, except per share amounts) (unaudited) Three Months Ended December 31, Year Ended December 31, 2025 2024 2025 2024 Revenues: Product sales, net $ 12,823 $ 29,587 $ 117,100 $ 120,849 Royalty revenue 719 495 1,613 2,012 Other revenue — 2,100 — 2,100 Total revenues 13,542 32,182 118,713 124,961 Costs and expenses: Cost of sales 3,266 11,611 35,383 39,227 Research and development expenses 486 1,286 1,690 3,822 Selling, general and administrative expenses 13,135 21,416 69,000 75,051 Change in fair value of contingent consideration — (544 ) (276 ) (244 ) Amortization of intangible assets 5,804 6,671 29,863 25,644 Impairment of intangible assets — 5,217 1,700 5,217 Restructuring charges 2,600 — 2,889 720 Total costs and expenses 25,291 45,657 140,249 149,437 Loss from operations (11,749 ) (13,475 ) (21,536 ) (24,476 ) Other income (expense): Loss on Assertio Therapeutics divestiture — — (8,174 ) — Interest expense (772 ) (763 ) (3,075 ) (3,039 ) Interest income 606 780 2,665 3,221 Other gain, net 168 2,709 180 2,765 Total other income (expense) 2 2,726 (8,404 ) 2,947 Net loss before income taxes (11,747 ) (10,749 ) (29,940 ) (21,529 ) Income tax (expense) benefit (181 ) 273 (435 ) (52 ) Net loss and comprehensive loss $ (11,928 ) $ (10,476 ) $ (30,375 ) $ (21,581 ) Basic and diluted net loss per share* $ (1.86 ) $ (1.65 ) $ (4.74 ) $ (3.40 ) Shares used in computing basic and diluted net loss per share* 6,420 6,367 6,403 6,351 (*) Basic and diluted net loss per share and shares used in computing basic and diluted net loss per share for the three months ended December 31, 2024 and the year ended December 31, 2024 have been adjusted to reflect the 1-for-15 reverse stock split effected on December 26, 2025. ASSERTIO HOLDINGS, INC. CONSOLIDATED BALANCE SHEETS (in thousands, except share data) (unaudited) December 31, 2025 2024 ASSETS Current assets: Cash and cash equivalents $ 10,229 $ 50,588 Short-term investments 53,176 49,466 Accounts receivable, net 120,110 54,120 Inventories, net 24,120 38,308 Prepaid and other current assets 9,011 10,067 Total current assets 216,646 202,549 Property and equipment, net 444 586 Intangible assets, net 48,908 80,471 Other long-term assets 972 1,126 Total assets $ 266,970 $ 284,732 LIABILITIES AND SHAREHOLDERS’ EQUITY Current liabilities: Accounts payable $ 9,014 $ 14,736 Accrued rebates, returns and discounts 99,366 76,304 Accrued liabilities 14,282 18,847 Contingent consideration, current portion — 726 Other current liabilities 4,851 4,075 Total current liabilities 127,513 114,688 Long-term debt 39,124 38,813 Other long-term liabilities 6,381 10,150 Total liabilities 173,018 163,651 Commitments and contingencies Shareholders’ equity: Common stock, $0.0001 par value, 200,000,000 shares authorized; 6,421,899 and 6,369,133 shares issued and outstanding as of December 31, 2025 and December 31, 2024, respectively* 1 1 Additional paid-in capital* 797,450 794,204 Accumulated deficit (703,499 ) (673,124 ) Total shareholders’ equity 93,952 121,081 Total liabilities and shareholders' equity $ 266,970 $ 284,732 (*) Shares issued and outstanding, common stock and additional paid-in capital as of December 31, 2024 have been adjusted to reflect the 1-for-15 reverse stock split effected on December 26, 2025. ASSERTIO HOLDINGS, INC. CONSOLIDATED STATEMENTS OF CASH FLOWS (in thousands) (unaudited) Year Ended December 31, 2025 2024 Operating Activities Net loss $ (30,375 ) $ (21,581 ) Adjustments to reconcile net loss to net cash (used in) provided by operating activities: Depreciation and amortization 30,005 25,829 Amortization of debt issuance costs 475 439 Accretion of interest income from short-term investments 93 (542 ) Impairment of intangible assets 1,700 5,217 Loss on Assertio Therapeutics divestiture 8,174 — Recurring fair value measurements of assets and liabilities (435 ) (397 ) Payment of contingent consideration (450 ) (1,730 ) Stock-based compensation 3,454 5,009 Provisions for inventory 4,510 8,960 Changes in assets and liabilities, net of acquisition: Accounts receivable (65,990 ) (6,457 ) Inventories 9,678 (9,583 ) Prepaid and other assets 1,209 4,334 Accounts payable and other accrued liabilities (13,292 ) (1,256 ) Accrued rebates, returns and discounts 23,062 18,166 Net cash (used in) provided by operating activities (28,182 ) 26,408 Investing Activities Assertio Therapeutics divestiture (8,174 ) — Proceeds from maturities of short-term investments 115,383 49,694 Purchases of short-term investments (119,197 ) (98,605 ) Net cash used in investing activities (11,988 ) (48,911 ) Financing Activities Payments related to the vesting and settlement of equity awards, net (189 ) (350 ) Net cash used in financing activities (189 ) (350 ) Net decrease in cash and cash equivalents (40,359 ) (22,853 ) Cash and cash equivalents at beginning of year 50,588 73,441 Cash and cash equivalents at end of year $ 10,229 $ 50,588 Supplemental Disclosure of Cash Flow Information Cash paid for interest $ 2,600 $ 2,600 RECONCILIATION OF GAAP NET LOSS TO NON-GAAP EBITDA and ADJUSTED EBITDA (in thousands) (unaudited) Three Months Ended December 31, Twelve months ended December 31, 2025 2024 2025 2024 Financial Statement Classification GAAP Net Loss $ (11,928 ) $ (10,476 ) $ (30,375 ) $ (21,581 ) Interest expense 772 763 3,075 3,039 Interest expense Income tax expense (benefit) 181 (273 ) 435 52 Income tax expense Depreciation expense 36 38 142 184 Selling, general and administrative expenses Amortization of intangible assets 5,804 6,671 29,863 25,644 Amortization of intangible assets EBITDA (Non-GAAP) (5,135 ) (3,277 ) 3,140 7,338 Adjustments: Legacy product reserves(1) — (2,100 ) — (2,100 ) Other revenue Stock-based compensation 97 1,098 3,454 5,009 Selling, general and administrative expenses Change in fair value of contingent consideration(2) — (544 ) (276 ) (244 ) Change in fair value of contingent consideration Employee Retention Credits(3) — — (2,383 ) — Selling, general and administrative expenses Legal settlements, net of insurance proceeds(4) — 3,965 3,543 1,149 Selling, general and administrative expenses Loss on Assertio Therapeutics divestiture and related charges(5) — — 9,309 — Multiple Expenses related to decommercialization of Otrexup(6) (900 ) — 4,160 — Multiple Impairment of intangible assets — 5,217 1,700 5,217 Impairment of intangible assets Restructuring costs(7) 2,600 — 2,889 720 Restructuring charges Other(8) (770 ) (920 ) (2,829 ) 1,203 Multiple Adjusted EBITDA (Non-GAAP) $ (4,108 ) $ 3,439 $ 22,707 $ 18,292 (1) Represents removal of the impact of revenue adjustment to reserves for product sales allowances (gross-to-net-sales allowances) estimates related to previously divested products. (2) The fair value of the contingent consideration is remeasured each reporting period, with changes in the fair value resulting from changes in the underlying inputs being recognized as a benefit or expense in operating expenses until the contingent consideration arrangement is settled. (3) Amounts related to income recognized in the period from the lapsing of the statute of limitations for employee retention tax credits. (4) Legal settlements, net of insurance proceeds, represents the net impact of legal settlements reached in the period. For the twelve months ended December 31, 2025, amount primarily includes the net impact of the Luo securities class action. Prior period amounts of Adjusted EBITDA have been recast to conform to this presentation. (5) For the twelve months ended December 31, 2025, amount includes the $8.2 million loss recognized upon the divestiture of the Assertio Therapeutics subsidiary including approximately $1.0 million of one-time costs included in SG&A incurred associated with the closing of the transaction. (6) Amounts related to costs incurred by the Company related to its decision to cease commercializing Otrexup. For the twelve months ended December 31, 2025, amount includes SG&A costs of $1.7 million and cost of sales of $2.5 million. These costs were primarily associated with the write-off of inventory (including inventory held at the Company’s contract manufacturers for Otrexup), the write-off of certain prepaid assets and the recognition of an accrual for the minimum purchase obligation required under the Otrexup supply agreement with Antares Pharma, Inc., and expenses associated with the settlement of legal claims related to ceasing commercialization of Otrexup. (7) Restructuring costs represent non-recurring costs associated with the Company’s announced restructuring plans. (8) Other for the three and twelve months ended December 31, 2025 and 2024 represent the following adjustments (in thousands): Three Months Ended December 31, Twelve months ended December 31, 2025 2024 2025 2024 Financial Statement Classification Amortization of inventory step-up $ — $ — $ — $ 4,564 Cost of sales Interest income (606 ) (780 ) (2,665 ) (3,221 ) Interest income Derivative fair value adjustment (164 ) (140 ) (164 ) (140 ) Other income, net Total Other $ (770 ) $ (920 ) $ (2,829 ) $ 1,203 RECONCILIATION OF GAAP NET LOSS and NET LOSS PER SHARE TO NON-GAAP ADJUSTED EARNINGS and ADJUSTED EARNINGS PER SHARE(1) (in thousands, except per share amounts) (unaudited) Three Months Ended December 31, 2025 2024 Amount Diluted EPS(2) Amount Diluted EPS*(2) Net loss per share (GAAP)(2) $ (11,928 ) $ (1.86 ) $ (10,476 ) $ (1.65 ) Add: Convertible debt interest expense and other income statement impacts, net of tax(2) — — Adjustments Amortization of intangible assets 5,804 6,671 Legacy products revenue reserves — (2,100 ) Stock-based compensation 97 1,098 Legal settlements, net of insurance proceeds — 3,965 Expenses related to decommercialization of Otrexup (900 ) — Change in fair value of contingent consideration — (544 ) Contingent consideration cash payable(3) — (1,099 ) Impairment of intangible assets — 5,217 Restructuring charges 2,600 — Other (770 ) (920 ) Income tax expense, as adjusted(4) (1,708 ) (1,768 ) Adjusted earnings (Non-GAAP) $ (6,805 ) $ (1.06 ) $ 44 $ 0.01 Diluted shares used in calculation (GAAP) *(2) 6,420 6,367 Add: Dilutive effect of stock-based awards and equivalents *(2) — 37 Add: Dilutive effect of 2027 Convertible Notes *(2) — — Diluted shares used in calculation (Non-GAAP) *(2) 6,420 6,404 (*) Diluted EPS, Diluted shares used in the calculation of diluted EPS and Adjusted earnings per share for the three months ended December 31, 2024 have been adjusted to reflect the 1-for-15 reverse stock split effected on December 26, 2025. (1) Certain adjustments included here are the same as those reflected in the Company’s reconciliation of GAAP net loss to non-GAAP adjusted EBITDA and therefore should be read in conjunction with that reconciliation and respective footnotes. (2) The Company uses the if-converted method with respect to its convertible debt to compute GAAP and Non-GAAP diluted earnings per share when the effect is dilutive. Under the if-converted method, the Company assumes the 2027 Convertible Notes were converted at the beginning of each period presented and outstanding. As a result, interest expense, net of tax, and any other income statement impact associated with the 2027 Convertible Notes, net of tax, is added back to net income used in the diluted earnings per share calculation. For the three months ended December 31, 2025, the Company’s potentially dilutive convertible debt under the if-converted method and stock-based awards under the treasury-stock method were not included in either the computation of GAAP net loss and diluted net loss per share or non-GAAP adjusted loss and adjusted loss per share, because to do so would be anti-dilutive. For the three months ended December 31, 2024, the Company’s potentially dilutive convertible debt under the if-converted method and stock-based awards under the treasury-stock method were not included in the computation of GAAP net loss and diluted net loss per share, and the potentially dilutive convertible debt under the if-converted method were not included in non-GAAP adjusted earnings and adjusted earnings per share, because to do so would be anti-dilutive. However, the potentially dilutive stock-based awards under the treasury-stock method were included in the computation of non-GAAP adjusted earnings and adjusted earnings per share because the effect was dilutive. (3) Represents the accrued cash payable, if any, of the INDOCIN contingent consideration for the respective period based on 20% royalty for annual INDOCIN net sales over $20.0 million. (4) Represents the Company’s income tax expense adjustment from the tax effect of pre-tax adjustments excluded from adjusted earnings. The tax effect of pre-tax adjustments excluded from adjusted earnings is computed at the blended federal and state statutory rate of 25%. RECONCILIATION OF GAAP NET LOSS and NET LOSS PER SHARE TO NON-GAAP ADJUSTED EARNINGS and ADJUSTED EARNINGS PER SHARE(1) (in thousands, except per share amounts) (unaudited) Twelve Months Ended December 31, 2025 2024 Amount Diluted EPS (2) Amount Diluted EPS*(2) Net loss (GAAP)(2) $ (30,375 ) $ (4.74 ) $ (21,581 ) $ (3.40 ) Add: Convertible debt interest expense and other income statement impacts, net of tax(2) — — Adjustments Amortization of intangible assets 29,863 25,644 Legacy products revenue reserves — (2,100 ) Stock-based compensation 3,454 5,009 Employee Retention Credits (2,383 ) — Legal settlements, net of insurance proceeds 3,543 1,149 Loss on Assertio Therapeutics divestiture and related charges 9,309 — Expenses related to decommercialization of Otrexup 4,160 — Change in fair value of contingent consideration (276 ) (244 ) Contingent consideration cash payable(3) — (1,352 ) Contingent consideration cash payable(3) 1,700 5,217 Restructuring charges 2,889 720 Other (2,829 ) 1,203 Income tax expense, as adjusted(4) (9,889 ) (7,507 ) Adjusted earnings (Non-GAAP) $ 9,166 $ 1.42 $ 6,158 $ 0.90 Diluted shares used in calculation (GAAP) *(2) 6,403 6,351 Add: Dilutive effect of stock-based awards and equivalents *(2) 34 516 Add: Dilutive effect of 2027 Convertible Notes *(2) — — Diluted shares used in calculation (Non-GAAP) *(2) 6,437 6,867 (*) Diluted EPS, Diluted shares used in the calculation of diluted EPS and Adjusted earnings per share for the year ended December 31, 2024 have been adjusted to reflect the 1-for-15 reverse stock split effected on December 26, 2025. (1) Certain adjustments included here are the same as those reflected in the Company’s reconciliation of GAAP net loss to non-GAAP adjusted EBITDA and therefore should be read in conjunction with that reconciliation and respective footnotes. (2) The Company uses the if-converted method with respect to its convertible debt to compute GAAP and non-GAAP diluted earnings per share when the effect is dilutive. Under the if-converted method, the Company assumes the 2027 Convertible Notes were converted at the beginning of each period presented and outstanding. As a result, interest expense, net of tax, and any other income statement impact associated with the 2027 Convertible Notes, net of tax, is added back to net income used in the diluted earnings per share calculation. For the twelve months ended December 31, 2025 and 2024, the Company’s potentially dilutive convertible debt under the if-converted method and stock-based awards under the treasury-stock method were not included in the computation of GAAP net loss and diluted net loss per share, and the potentially dilutive convertible debt under the if-converted method were not included in non-GAAP adjusted earnings and adjusted earnings per share, because to do so would be anti-dilutive. However, the potentially dilutive stock-based awards under the treasury-stock method were included in the computation of non-GAAP adjusted earnings and adjusted earnings per share because the effect was dilutive. (3) Represents the accrued cash payable, if any, of the INDOCIN contingent consideration for the respective period based on 20% royalty for annual INDOCIN net sales over $20.0 million. (4) Represents the Company’s income tax expense adjustment from the tax effect of pre-tax adjustments excluded from adjusted earnings. The tax effect of pre-tax adjustments excluded from adjusted earnings is computed at the blended federal and state statutory rate of 25%. View source version on businesswire.com: https://www.businesswire.com/news/home/20260316015407/en/ Investor Contact Longacre Square Partners assertio@longacresquare.com Source: Assertio Holdings, Inc.

Reaffirms guidance to resubmit Anaphylm™ (dibutepinephrine) sublingual film NDA in Q3 2026; Type A meeting with FDA expected to occur within 30 days On track to submit regulatory applications for Anaphylm in Canada and the EU in 2026 Extends revenue sharing agreement with RTW to June 30, 2027 Excluding one-time items, meets 2025 guidance for revenue and non-GAAP adjusted EBITDA loss Guides to end FY2026 with cash and cash equivalents of $70 million Company to host investment community conference call on March 5, 2026 WARREN, N.J., March 04, 2026 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today reported financial results for the fourth quarter and full year ended December 31, 2025, and provided a progress update on the Company's key 2026 objectives. "We are well-positioned in 2026 to advance Anaphylm, the first and only oral epinephrine rescue medication, towards approval for patients around the world," said Daniel Barber, President and Chief Executive Officer of Aquestive. "We continue to believe the value proposition will be transformative and ultimately save lives. We are focused on rapidly addressing the human factors focused deficiencies cited by the FDA in their recent Complete Response Letter. Our commercial infrastructure is intact and transferable to our new timeline, the allergy market continues to grow, and patient preference remains strongly in favor of the innovation Anaphylm represents. As recently announced, we have strengthened our leadership with the addition of Dr. Greenhawt, an internationally recognized expert in allergy and immunology, as the Chief Medical Officer of the Company. Additionally, we remain well-positioned financially to launch Anaphylm in the U.S., if approved by the FDA. We've never been more confident in Anaphylm's potential to make a meaningful difference for the allergy community." Anaphylm™ (dibutepinephrine) Sublingual Film Anaphylm is a non-device based epinephrine product candidate being developed for the treatment of Type I allergic reactions, including anaphylaxis. The Company believes Anaphylm has the potential to be the first and only non-invasive, orally delivered epinephrine product, if approved by the U.S. Food and Drug Administration (FDA). On January 30, 2026, Aquestive received a Complete Response Letter (CRL) from the FDA for the New Drug Application (NDA) for Anaphylm in patients weighing 30 kilograms or more. The CRL identified deficiencies related to human factors validation, including potential challenges associated with pouch opening and film placement, as well as a request for a single pharmacokinetics (PK) study to assess the impact of packaging and labeling modifications. The FDA also provided labeling comments intended to inform the final label, if approved by the FDA. The CRL did not identify any chemistry, manufacturing, or controls (CMC) deficiencies, and clinical results submitted as part of the NDA regarding comparability to auto-injectors (such as EpiPen ® and Auvi-Q ® ), such as bracketing, repeat dose, and sustainability, were not questioned. No additional studies beyond the requested human factors validation study and related PK study were identified. The FDA indicated that the human factors and PK studies may be conducted in parallel. To address the items outlined in the CRL, a new human factors validation study and a PK study are planned. A Type A meeting with the FDA has been requested to discuss the most efficient path forward for resubmission, with the NDA anticipated to be resubmitted in the third quarter of 2026, subject to completion of the required studies and expected FDA response timelines. The Company plans to request an accelerated review upon resubmission, but no expedited review can be guaranteed. The Company continues to advance its global expansion strategy for Anaphylm, including ongoing regulatory engagement in Canada and preparatory activities in the European Union. These efforts are intended to support potential future submissions and expand access to the Company’s non-invasive epinephrine therapy globally. Aquestive will continue to prepare for the launch of Anaphylm, a potentially transformative product for the emergency treatment of severe allergic reactions, including anaphylaxis. The initial focus of the Company's launch preparation is to optimize Anaphylm's market access for patients, if approved by the FDA. Aquestive is also increasing awareness of Anaphylm through the continued execution of its medical affairs strategy, including presenting scientific data at medical forums throughout 2026. The Company remains committed to a successful launch of Anaphylm, if approved by the FDA. AQST-108 (epinephrine) Topical Gel AQST-108 is a topical epinephrine prodrug gel product candidate being evaluated for alopecia areata (AA) and other potential dermatologic or localized indications. In December 2025, the Company successfully opened an Investigational New Drug (IND) application for AQST-108 with the FDA and received supportive written feedback for continued development of this product candidate. An initial first-in-human clinical trial of AQST-108 evaluated topical application and systemic exposure and did not identify any serious or topical adverse events. Building on these results, the Company successfully completed dosing in a second Phase 1 clinical trial in the first quarter of 2026 and the data readout from the study is expected in the second quarter of 2026. The intent of this study is to further characterize the safety, tolerability, and pharmacologic pro the program and to inform potential future development opportunities, including indication selection. An estimated 6.7 million people in the United States have been affected by AA. Of those affected, 43% are considered severe. The existing therapies for AA are janus kinase (or JAK) inhibitors. These systemic treatments with known side effects come with a "black box" warning and are expensive for patients. Even with these limitations, the current estimated market opportunity for JAK inhibitors is over One Billion U.S. dollars. Since AQST-108 is topical and there is evidence that it acts at the application site, it may not have systemic side effects. As a result of these conditions, AQST-108, if approved by the FDA as a treatment for AA, has the potential to capture meaningful market share for the treatment of these patients. The topical formulation of AQST-108 is designed to act locally at the site of application, which may support evaluation in settings where minimizing systemic exposure is desirable. This localized delivery approach provides an opportunity to explore additional value for this product beyond a single indication, while maintaining a disciplined, data-driven development strategy. Commercial Collaborations Aquestive continues to manufacture products for the licensing and supply collaborations that it has established. The Company manufactured approximately 47 million doses in the fourth quarter 2025, compared to approximately 43 million doses in the fourth quarter 2024. The Company continues to manufacture Indivior’s Suboxone ® Sublingual Film product and the Company's other global collaborations, including Sympazan ® (clobazam) Oral Film product for Assertio Holdings, Inc. in the U.S., Ondif ® (Ondansetron) Oral Film product for Hypera Pharma in Brazil and Emylif® (riluzole) Oral Film product by Zambon S.p.A in Europe. Aquestive’s manufacturing business remains steady, with the gradual decline of Suboxone being offset by growth across newer collaborations. The Company, being a U.S. based manufacturer with intellectual property domiciled in the U.S., confirms that its supply chain currently remains largely unaffected by both implemented and proposed government tariffs, providing continued reliability and stability in production and global distribution for the near term. Sales of royalty-based products, inclusive of Sympazan ® (clobazam) Oral Film for the treatment of seizures associated with Lennox-Gastaut Syndrome in patients two years of age and older, and Azstarys ® (serdexmethylphenidate and dexmethylphenidate) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients six years of age and older, continued to contribute to the Company's revenue in the fourth quarter of 2025. Libervant ® (diazepam) Buccal Film remains tentatively approved until January 2027, the scheduled date of expiration of U.S. market orphan drug exclusivity of an FDA approved product of another company. Aquestive continues to believe that expanding patient access to non-invasive seizure rescue therapies is vital and remains committed to putting Libervant in the hands of patients when granted full approval for U.S. market access by the FDA. RTW Amendment, Warrant and Share Purchase Agreement On March 3, 2026, the Company entered into Amendment No. 1 to the Purchase and Sale Agreement, dated August 13, 2025, with funds managed by RTW Investments, LP ("RTW"). The Amendment extends the marketing approval deadline for Anaphylm from its original date to June 30, 2027. Concurrently, the Company entered into a Warrant Issuance Agreement with funds managed by RTW, pursuant to which the Company agreed to issue a warrant to such funds to purchase up to 375,000 shares of the Company's common stock, par value $0.001 per share (the “Common Stock”), at an exercise price of $4.00 per share, expiring on March 3, 2029. On March 3, 2026, the Company also entered into a Share Purchase Commitment Agreement with certain RTW-affiliated funds, pursuant to which such funds committed to purchase, in the aggregate, not less than $5,000,000 of Common Stock during the 90-day period following the effective date of the agreement, at the then current market price as of the date of such purchase(s), as determined in accordance with Rule 415(a)(4) under the Securities Act of 1933, as amended. Legal Settlement In December 2025, Aquestive entered into a confidential legal settlement with Neurelis, Inc. related to a civil tort case filed by Neurelis, Inc. in December 2019. Net of insurance payments and reduced ongoing legal costs, Aquestive expects the cash impact in 2026 of such settlement to be the same as or lower than forecasted prior to the settlement. Fourth Quarter 2025 Financials Total revenues increased to $13.0 million in the fourth quarter 2025, from $11.9 million in the fourth quarter 2024. This 10% increase in revenue was primarily driven by increases in manufacture and supply revenue. Manufacture and supply revenue increased to $12.0 million in the fourth quarter 2025 from $10.7 million in the fourth quarter 2024, primarily due to increases in Suboxone revenues and Ondif revenues. Research and development (R&D) expenses decreased to $3.2 million in the fourth quarter 2025 from $4.9 million in the fourth quarter 2024. The decrease in R&D expenses was primarily due to a decrease in clinical trial costs associated with the continued advancement of the Anaphylm development program and decreases in R&D personnel costs and share-based compensation. Excluding one-time legal expenses, selling, general and administrative expenses increased to $19.6 million in the fourth quarter 2025 from $16.0 million in the fourth quarter 2024. Including the one-time legal expenses, selling, general and administrative expenses increased to $32.8 million in the fourth quarter 2025 from $16.0 million in the fourth quarter 2024, primarily due to higher legal expenses of approximately $13.6 million, higher commercial spending of approximately $3.7 million in preparation for the planned launch of Anaphylm, higher personnel expenses of approximately $0.8 million, and higher share-based compensation of approximately $0.2 million, partially offset by lower severance expenses of approximately $1.7 million, and lower regulatory and licensing fees of approximately $0.5 million. Excluding one-time legal expenses, Aquestive’s net loss for the fourth quarter 2025 was $18.7 million, or $0.15 for both basic and diluted loss per share, compared to the net loss for the fourth quarter 2024 of $17.1 million, or $0.19 for both basic and diluted loss per share. Including one-time legal expenses, Aquestive’s net loss for the fourth quarter 2025 was $31.9 million, or $0.26 for both basic and diluted loss per share, compared to the net loss for the fourth quarter 2024 of $17.1 million, or $0.19 for both basic and diluted loss per share. The increase in net loss was primarily driven by increases in selling, general and administrative expenses, and manufacture and supply expenses, partially offset by decreases in research and development expenses and increases in revenues and interest income and other income, net. Excluding one-time legal expenses, Non-GAAP adjusted EBITDA loss was $14.1 million in the fourth quarter 2025, compared to Non-GAAP adjusted EBITDA loss of $11.0 million in the fourth quarter 2024. Non-GAAP adjusted EBITDA loss excluding adjusted R&D expenses and one-time legal expenses was $10.8 million in the fourth quarter 2025, compared to a Non-GAAP adjusted EBITDA loss excluding adjusted R&D expenses of $6.6 million in the fourth quarter 2024. Full Year 2025 Financials Excluding the impact of one-time recognition of deferred revenues during the full year 2024, total revenues decreased by $1.5 million, or 3% to $44.5 million for the full year 2025. As a reminder, the one-time recognition of deferred revenue in the prior year was due to the termination of licensing and supply agreements. Including the deferred revenue recognized in the prior year, total revenues decreased to $44.5 million for the full year 2025 from $57.6 million for the full year 2024. Manufacture and supply revenue increased to $40.2 million for the full year 2025 from $40.0 million for the full year 2024, primarily due to increases in Ondif revenues, partially offset by decreases in Suboxone revenues. R&D expenses decreased to $17.2 million for the full year 2025 from $20.3 million in the full year 2024. The decrease in R&D expenses was primarily due to lower clinical trial costs associated with the continued advancement of the Anaphylm development program, partially offset by increases in product research expenses as well as R&D personnel costs and share-based compensation. Excluding one-time legal expenses, selling, general and administrative expenses increased to $66.6 million for the full year 2025 from $50.2 million for the full year 2024. Including one-time legal expenses, selling, general and administrative expenses increased to $79.8 million for the full year 2025 from $50.2 million for the full year 2024. The increase primarily represents higher legal expenses of approximately $14.3 million, higher commercial spending of approximately $9.6 million in preparation for the planned launch of Anaphylm, Anaphylm PDUFA fee of $4.3 million, higher personnel expenses of approximately $1.9 million, higher regulatory expenses related to Anaphylm of approximately $1.0 million, and higher share-based compensation expenses of approximately $0.9 million, partially offset by lower severance expenses of approximately $2.8 million, and lower insurance expenses of approximately $0.6 million. Excluding one-time legal expenses, Aquestive's net loss for the full year 2025 was $70.6 million, or $0.66 for both basic and diluted loss per share, compared to the net loss for the full year 2024 of $44.1 million, or $0.51 for both basic and diluted loss per share. Including one-time legal expenses, Aquestive's net loss for the full year 2025 was $83.8 million, or $0.78 for both basic and diluted loss per share, compared to the net loss for the full year 2024 of $44.1 million, or $0.51 for both basic and diluted loss per share. The increase in net loss was primarily driven by increases in selling, general and administrative expenses, and manufacture and supply expenses, and decreases in revenues, partially offset by decreases in R&D expenses and increases in interest income and other income, net. Excluding one-time legal expenses, Aquestive's Non-GAAP adjusted EBITDA loss was $49.7 million for the full year 2025, compared to Non-GAAP adjusted EBITDA loss of $23.0 million for the full year 2024. Non-GAAP adjusted EBITDA loss excluding adjusted R&D expenses and one-time legal expenses was $34.4 million for the full year 2025, compared to Non-GAAP adjusted EBITDA loss excluding adjusted R&D expenses of $4.0 million for the full year 2024. As of December 31, 2025, cash and cash equivalents were $121.2 million. 2026 Outlook Aquestive is providing its full year 2026 financial outlook. The Company expects: Guidance Total revenue (in millions) $46 to $50 Non-GAAP adjusted EBITDA loss (in millions) $35 to $30 Our Non-GAAP adjusted EBITDA loss guidance for 2026 includes costs associated with the resubmission of the NDA for Anaphylm, continued pre-commercial infrastructure spending for Anaphylm, clinical trial for AQST-108, and regulatory applications for Anaphylm in Canada and the EU. Current guidance does not include costs associated with the sales and marketing of Anaphylm, if approved by the FDA. Tomorrow’s Conference Call and Webcast Reminder The Company will host a conference call at 8:00 a.m. EST on Thursday, March 5, 2026. In order to participate, please register in advance here to obtain a local or toll-free phone number and your personal pin. A live webcast of the call will be available on the "Events and Presentations" page of the Investor section of Aquestive’s website: Fourth Quarter 2025 Earnings Call. The webcast will be archived for 30 days. About Anaphylm™ Anaphylm™ (epinephrine) sublingual film is a polymer matrix-based epinephrine prodrug product. Anaphylm is similar in size to a postage stamp, weighs less than an ounce, and begins to dissolve on contact. No water or swallowing is required for administration. The primary packaging for Anaphylm is thinner and smaller than an average credit card, can be carried in a pocket, and is designed to withstand weather excursions such as exposure to rain and/or sunlight. The Anaphylm trade name for AQST-109 has been conditionally approved by the FDA. Final approval of the Anaphylm proprietary name is conditioned on FDA approval of the product candidate. About AQST-108 AQST-108 (epinephrine) topical gel is a topically delivered adrenergic agonist prodrug product candidate. Aquestive completed a first in human study for AQST-108 without any serious or topical adverse events. AQST-108 is based on Aquestive’s Adrenaverse™ platform which contains a library of over twenty epinephrine prodrug product candidates intended to control absorption and conversion rates across a variety of possible dosage forms and delivery sites. About Libervant ® Libervant ® (diazepam) buccal film is a buccally, or inside of the cheek, administered film formulation of diazepam, a benzodiazepine intended for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity ( i.e. , seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy. Aquestive developed Libervant as an alternative to the device-based products currently available for patients with refractory epilepsy, including a rectal gel and nasal spray products. The FDA approval for U.S. market access received in April 2024 for Libervant was for these epilepsy patients between two and five years of age. However, the FDA converted this approval to a "tentative approval" due to a recent court ruling finding that the FDA did not have authority to approve Libervant for U.S. market access for patients aged between two and five years due to the existing orphan drug market exclusivity granted by the FDA to an intranasal spray of another company. The FDA granted tentative approval in August 2022 for Libervant for treatment of these epilepsy patients twelve years of age and older. U.S. market access for Libervant patients is currently subject to the expiration of the existing orphan drug market exclusivity of the previously FDA approved drug scheduled to occur in January 2027. Important Safety Information Do not give Libervant to your child between the ages of two and five if your child is allergic to diazepam or any of the ingredients in Libervant or has an eye problem called acute narrow angle glaucoma. What is the most important information I should know about Libervant? Libervant is a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system (CNS) depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma, and death. Get emergency help right away if any of the following happens: shallow or slowed breathing, breathing stops (which may lead to the heart stopping), excessive sleepiness (sedation). Do not allow your child to drive a motor vehicle, operate heavy machinery, or ride a bicycle until you know how taking Libervant with opioids affects your child. Risk of abuse, misuse, and addiction. Libervant is used in children 2 to 5 years of age. The unapproved use of Libervant has a risk for abuse, misuse, and addiction, which can lead to overdose and serious side effects including coma and death. Serious side effects including coma and death have happened in people who have abused or misused benzodiazepines, including diazepam (the active ingredient in Libervant). These serious side effects may also include delirium, paranoia, suicidal thoughts or actions, seizures, and difficulty breathing. Call your child’s healthcare provider or go to the nearest hospital emergency room right away if you get any of these serious side effects. Your child can develop an addiction even if your child takes Libervant as prescribed by your child’s healthcare provider. Give Libervant exactly as your child’s healthcare provider prescribed. Do not share Libervant with other people. Keep Libervant in a safe place and away from children. Physical dependence and withdrawal reactions. Libervant is intended for use if needed in order to treat higher than usual seizure activity. Benzodiazepines , including Libervant, can cause physical dependence and withdrawal reactions, especially if used daily. Libervant is not intended for daily use. Do not suddenly stop giving Libervant to your child without talking to your child’s healthcare provider. Stopping Libervant suddenly can cause serious and life-threatening side effects, including, unusual movements, responses, or expressions, seizures that will not stop (status epilepticus), sudden and severe mental or nervous system changes, depression, seeing or hearing things that others do not see or hear, homicidal thoughts, an extreme increase in activity or talking, losing touch with reality, and suicidal thoughts or actions. Call your child’s healthcare provider or go to the nearest hospital emergency room right away if your child gets any of these symptoms. Some people who suddenly stop benzodiazepines have symptoms that can last for several weeks to more than 12 months including, anxiety, trouble remembering, learning, or concentrating, depression, problems sleeping, feeling like insects are crawling under your skin, weakness, shaking, muscle twitching, burning, or prickling feeling in your hands, arms, legs or feet, and ringing in your ears. Physical dependence is not the same as drug addiction. Your child’s healthcare provider can tell you more about the differences between physical dependence and drug addiction. Do not give your child more Libervant than prescribed or give Libervant more often than prescribed. Libervant can make your child sleepy or dizzy and can slow your child’s thinking and motor skills. Do not allow your child to drive a motor vehicle, operate machinery, or ride a bicycle until you know how Libervant affects your child. Do not give other drugs that may make your child sleepy or dizzy while taking Libervant without first talking to your child’s healthcare provider. When taken with drugs that cause sleepiness or dizziness, Libervant may make your child’s sleepiness or dizziness much worse. Like other antiepileptic medicines, Libervant may cause suicidal thoughts or actions in a small number of people, about 1 in 500. Call a healthcare provider right away if your child has any of these symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying new or worse depression feeling agitated or restless trouble sleeping (insomnia) acting aggressive, being angry or violent other unusual changes in behavior or mood attempts to commit suicide new or worse anxiety or irritability an extreme increase in activity and talking (mania) new or worse panic attacks acting on dangerous impulses Pay attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings. Keep all follow-up visits with your child’s healthcare provider as scheduled. Call your child’s healthcare provider between visits as needed, especially if you are worried about symptoms. Suicidal thoughts or actions can be caused by things other than medicines. If your child has suicidal thoughts or actions, your child’s healthcare provider may check for other causes. What are the possible side effects of Libervant? The most common side effects of Libervant are sleepiness and headache. These are not all the possible side effects of Libervant. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1 800 FDA-1088. For more information about Libervant, talk to your doctor, and see Product Information: Medication Guide and Instructions For Use. About Aquestive Therapeutics , Inc. Aquestive is a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies. The worldwide leader in delivering trusted, quality medications on oral film, Aquestive operates as both a developer of its own proprietary products and a Contract Development and Manufacturing Organization (CDMO) for licensees, with its headquarters in New Jersey and U.S.-based manufacturing facilities in Indiana. The Company is the exclusive manufacturer of four commercialized products marketed by its licensees across six continents using proprietary, best-in-class technologies like PharmFilm®. Aquestive's AdrenaVerse™ platform contains a library of more than 20 epinephrine prodrugs enabling the pursuit of various potential allergy and dermatological indications. The Company is advancing Anaphylm™ (dibutepinephrine) sublingual film for the treatment of severe allergic reactions, including anaphylaxis, and AQST-108 (epinephrine prodrug) topical gel for various potential dermatological conditions, including alopecia areata. For more information, visit Aquestive.com and follow us on LinkedIn. Non-GAAP Financial Information This press release and our webcast earnings call regarding our quarterly financial results contains financial measures that do not comply with U.S. generally accepted accounting principles (GAAP), such as non-GAAP adjusted EBITDA loss, non-GAAP adjusted EBITDA loss excluding one-time legal expenses, non-GAAP adjusted EBITDA loss excluding adjusted R&D expenses and one-time legal expenses, non-GAAP adjusted gross margins, non-GAAP adjusted costs and expenses and other adjusted expense measures, because such measures exclude, as applicable, share-based compensation expense, interest expense, interest expense related to the sale of future revenue, interest income, depreciation, amortization, and income taxes.  Specifically, the Company adjusts net loss for certain non-cash expenses, including share-based compensation expenses; depreciation and amortization; and interest expense related to the sale of future revenue, interest income and other income, net and income taxes, with a result of adjusted EBITDA loss. Similarly, manufacture and supply expense, R&D expense, and selling, general and administrative expense were adjusted for certain non-cash expenses of share-based compensation expense and depreciation and amortization. Adjusted EBITDA loss and these non-GAAP expense categories are used as a supplement to the corresponding GAAP measures to provide additional insight regarding the Company’s ongoing operating performance.  These measures supplement the Company’s financial results prepared in accordance with GAAP. Aquestive management uses these measures to analyze its financial results, and its future manufacture and supply expenses, gross margins, R&D expense and selling, general and administrative expense and to help make managerial decisions. In management’s opinion, these non-GAAP measures provide added transparency into the operating performance of Aquestive and added insight into the effectiveness of our operating strategies and actions. The Company may provide one or more revenue measures adjusted for certain discrete items, such as fees collected on certain licensed products, in order to provide investors added insight into our revenue stream and breakdown, along with providing our GAAP revenue. Such measures are intended to supplement, not act as substitutes for, comparable GAAP measures and should not be read as a measure of liquidity for Aquestive. Adjusted EBITDA loss and the other non-GAAP measures are also likely calculated in a way that is not comparable to similarly titled measures reported by other companies. Non-GAAP Outlook In providing the outlook for non-GAAP adjusted EBITDA and non-GAAP gross margin, we exclude certain items which are otherwise included in determining the comparable GAAP financial measures. In order to inform our outlook measures of non-GAAP adjusted EBITDA and non-GAAP gross margin, a description of the adjustments which have been applicable in determining non-GAAP Adjusted EBITDA and non-GAAP gross margin for these periods are reflected in the tables below. In providing outlook for non-GAAP gross margin, the Company adjusts for non-cash share-based compensation expense and depreciation and amortization. The Company is providing such outlook only on a non-GAAP basis because the Company is unable to predict with reasonable certainty the totality or ultimate outcome or occurrence of these adjustments for the forward-looking period such as share-based compensation expense, income tax, amortization, and certain other adjusted items, which can be dependent on future events that may not be reliably predicted. Based on past reported results, where one or more of these items have been applicable, such excluded items could be material, individually or in the aggregate, to reported results. Forward-Looking Statement Certain statements in this press release include “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe,” “anticipate,” “plan,” “expect,” “estimate,” “intend,” “may,” “will,” or the negative of those terms, and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding the advancement and related timing of our product candidate Anaphylm™ (dibutepinephrine) sublingual film through clinical development and approval by the FDA, including our ability to address the concerns raised by the FDA in the CRL dated January 30, 2026, the timing of our resubmission of the NDA and a Type A meeting with the FDA and expedited review for Anaphylm; the advancement and related timing of potential international regulatory filings and marketing authorization of Anaphylm outside of the U.S.; that Anaphylm will be the first and only oral administration of epinephrine, if Anaphylm is approved by the FDA; that the Company’s commercialization plans and programs for Anaphylm will enable the Company to effectively compete in the market, if approved by the FDA; the advancement, growth and related timing of our AdrenaVerse™ pipeline epinephrine prodrug product candidates, including AQST-108 (epinephrine) topical gel, through clinical development and FDA regulatory approval process, including design and timing of clinical studies including those necessary to support the targeted indication of alopecia areata, and potential other treatment indications for AQST-108; market access for Libervant® (diazepam) buccal film for epilepsy patients experiencing acute repetitive seizures (ARS) upon expiration of orphan drug market exclusivity of an approved FDA product of another company; the future commercial opportunity of Anaphylm and AQST-108 should Anaphylm and AQST-108 be approved by the FDA; the potential benefits our product candidates could bring to patients, including with respect to Anaphylm, Libervant and AQST-108, if these product candidates are approved by the FDA, and acceptance by patients, prescribers and payors of our product candidates as an alternative to existing standards of care for the targeted medical indication of these product candidates; that the Company is sufficiently capitalized with sufficient cash in 2026 to perform the necessary clinical work and provide the additional information required to address the concerns of the FDA outlined in the CRL; that our supply chain is largely unaffected by implemented and proposed government tariffs and will be reliable and stable in production and global distribution for the near term; our cash requirements, cash funding and cash burn; short-term and longer term liquidity and the ability to fund our business operations; our growth and future financial and operating results and financial position, including with respect to our 2026 financial outlook; and business strategies, market opportunities, and other statements that are not historical facts. These forward-looking statements are based on our current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Such risks and uncertainties include, but are not limited to, risks associated with our development work, including any delays or changes to the timing, cost and success of our product development activities and clinical trials and plans for Anaphylm and AQST-108; risk of delays in advancement of the regulatory approval process through the FDA of our product candidates Anaphylm, Libervant and AQST-108, or failure to receive FDA approval at all of any or all of these product candidates; risk of FDA inspections of manufacturing and clinical study sites for any of our product candidates, including Anaphylm, Libervant and AQST-108; risk of government shutdowns or actions to reduce government workforces on the ability of the FDA to act on the approval of our product candidates, including Anaphylm, Libervant and AQST-108; risk of the Company’s ability to generate sufficient clinical and other human factor data, including with respect to our submission of pharmacokinetic and pharmacodynamic (PK/PD) comparability data for FDA approval of Anaphylm; risks associated with our ability to address the FDA’s comments on and identified deficiencies in our NDA, including the concerns raised by the FDA in the CRL for Anaphylm and whether the FDA may request further information from us (including additional clinical studies), disagree with our findings or otherwise undertake a lengthy review of the resubmission of our NDA, and challenges regarding the following commercial launch of Anaphylm, if approved by the FDA; risks associated with the success of any competing products, including generics; risks and uncertainties inherent in commercializing a new product (including technology risks, financial risks, market risks and implementation risks and regulatory limitations); risk of development of a sales and marketing capability for commercialization of our product candidates, including Anaphylm, Libervant and AQST-108, if these product candidates are approved by the FDA; risks associated with the potential impact on the value of the Company of the sale or outlicensing of our product candidates, including Anaphylm, Libervant and AQST-108; risk of sufficient capital and cash resources, including sufficient access to available debt and equity financing, including under our ATM facility, and revenues from operations, to satisfy all of our short-term and longer-term liquidity and cash requirements to support our growth strategy, and other cash needs, at the times and in the amounts needed, including to commence principal payments on our 13.5% Senior Secured Notes in 2026, and to fund future clinical development and commercial activities for our product candidates, including Anaphylm, Libervant and AQST-108, should these product candidates be approved by the FDA; risk of the impact of our obligations under the Company's Purchase Agreement and the Royalty Rights Agreement with third parties, each of which agreements requires the Company to make payments to each counterparty thereof, respectively, of a portion of our revenues, on our ability to contribute to the funding of our operations and the payment of principal and interest on our debt; the risk of our obligations under such Purchase Agreement and Royalty Rights Agreement impacting our ability to refinance our 13.5% Senior Secured Notes; risk that our manufacturing capabilities will be sufficient to support demand of our product candidates in the U.S. and abroad, including Anaphylm and Libervant, if such product candidates should be approved by the FDA and other regulatory authorities, and our licensed products in the U.S. and abroad; risk of eroding market share for Suboxone® as a sunsetting product, which accounts for a substantial part of our current operating revenue; risk of default of our debt instruments; risks related to the outsourcing of certain sales, marketing and other operational and staff functions to third parties; risk of the rate and degree of market acceptance in the U.S. and abroad of our product candidates, including Anaphylm and Libervant, should these product candidates be approved by the FDA and other regulatory authorities, and for our licensed products in the U.S. and abroad; risk associated with the size and growth of our product markets and expected related revenues and sales; risk associated with our compliance with all FDA and other governmental and customer requirements for our manufacturing facilities; risks associated with intellectual property rights and infringement claims relating to our products; risk that our patent applications for our product candidates, including for Anaphylm, will not be timely issued, or issued at all, by the U.S. Patent and Trademark Office or, if issued, will be sufficient to provide long-term commercial success of these product candidates; risk of unexpected patent developments; risk of legislation and regulatory actions and changes in laws or regulations affecting our business, including relating to our products and product candidates and product pricing, reimbursement or access therefor; risk of loss of significant customers; risks related to claims and legal proceedings against us including patent infringement, securities, business torts, investigative, product safety or efficacy and antitrust litigation matters; risk of product recalls and withdrawals; risks related to any disruptions in our information technology networks and systems, including the impact of cybersecurity attacks; risk of increased cybersecurity attacks and data accessibility disruptions due to remote working arrangements; risk of adverse developments affecting the financial services industry; risks related to inflation and changing interest rates; risks related to the impact of pandemic diseases on our business; risks and uncertainties related to general economic, political (including the Ukraine and Israel wars and other acts of war and terrorism), business, industry, regulatory, financial and market conditions and other unusual items; risks related to uncertainty about presidential administration initiatives and their impact on our business, including imposition of government tariffs and other trade restrictions; and other uncertainties affecting the Company including those described in the "Risk Factors" section and in other sections included in the Company’s Annual Report on 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K filed with the U.S. Securities and Exchange Commission. Given those uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date made. All subsequent forward-looking statements attributable to the Company or any person acting on its behalf are expressly qualified in their entirety by this cautionary statement. The Company assumes no obligation to update forward-looking statements or outlook or guidance after the date of this press release whether as a result of new information, future events or otherwise, except as may be required by applicable law. PharmFilm®, Libervant®, Sympazan® and the Aquestive logo are registered trademarks of Aquestive Therapeutics, Inc. All other registered trademarks referenced herein are the property of their respective owners. Investor inquiries: Astr Partners Brian Korb brian.korb@asterpartners.com AQUESTIVE THERAPEUTICS, INC. Balance Sheets (In thousands, except share and per share amounts) (Unaudited) December 31, 2025 2024 Assets Current assets: Cash and cash equivalents $ 121,169 $ 71,546 Trade and other receivables, net 17,763 7,344 Inventories, net 6,169 6,044 Prepaid expenses and other current assets 4,168 3,286 Total current assets 149,269 88,220 Property and equipment, net 3,893 3,799 Right-of-use assets, net 4,621 5,182 Other non-current assets 2,642 4,223 Total assets $ 160,425 $ 101,424 Liabilities and stockholders’ deficit Current liabilities: Accounts payable $ 29,862 $ 10,287 Accrued expenses 5,029 5,907 Lease liabilities, current 631 510 Deferred revenue, current 1,092 1,048 Liability related to the sale of future revenue, current 1,000 1,000 Royalty obligations, current — 87 Loans payable, current 9,994 26 Total current liabilities 47,608 18,865 Loans payable, net 27,519 32,500 Royalty obligations, net 25,941 20,129 Liability related to the sale of future revenue, net 62,023 62,718 Lease liabilities 4,337 4,968 Deferred revenue, net of current portion 19,390 20,005 Other non-current liabilities 7,269 2,395 Total liabilities 194,087 161,580 Contingencies Stockholders’ deficit: Common stock, $0.001 par value. Authorized 250,000,000 shares; 122,044,299 and 91,413,742 shares issued and outstanding at December 31, 2025 and December 31, 2024, respectively 122 91 Additional paid-in capital 413,214 302,967 Accumulated deficit (446,998 ) (363,214 ) Total stockholders’ deficit (33,662 ) (60,156 ) Total liabilities and stockholders’ deficit $ 160,425 $ 101,424 AQUESTIVE THERAPEUTICS, INC. Statements of Operations and Comprehensive Loss (In thousands, except share and per share data amounts) (Unaudited) Three Months Ended December 31, Year Ended December 31, 2025 2024 2025 2024 Revenues $ 13,015 $ 11,867 $ 44,545 $ 57,561 Costs and expenses: Manufacture and supply 5,836 4,520 18,555 17,872 Research and development 3,196 4,917 17,192 20,280 Selling, general and administrative 32,822 16,009 79,849 50,180 Total costs and expenses 41,854 25,446 115,596 88,332 Loss from operations (28,839 ) (13,579 ) (71,051 ) (30,771 ) Other income (expenses): Interest expense (2,778 ) (2,779 ) (11,120 ) (11,122 ) Interest expense related to royalty obligations (1,433 ) (1,384 ) (5,737 ) (5,459 ) Interest expense related to the sale of future revenue (62 ) (61 ) (243 ) (236 ) Interest income and other income, net 1,252 734 4,367 3,437 Net loss before income taxes (31,860 ) (17,069 ) (83,784 ) (44,151 ) Income taxes benefit — 14 — 14 Net loss $ (31,860 ) $ (17,055 ) $ (83,784 ) $ (44,137 ) Comprehensive loss $ (31,860 ) $ (17,055 ) $ (83,784 ) $ (44,137 ) Loss per share attributable to common stockholders: Basic and diluted (in dollars per share) $ (0.26 ) $ (0.19 ) $ (0.78 ) $ (0.51 ) Weighted average common shares outstanding: Basic and diluted (in shares) 121,966,911 91,199,407 106,926,528 86,726,211 AQUESTIVE THERAPEUTICS, INC. Reconciliation of Non-GAAP Adjustments - Net Loss to Adjusted EBITDA (In Thousands) (Unaudited) Three Months Ended December 31, Year Ended December 31, 2025 2024 2025 2024 GAAP net loss $ (31,860 ) $ (17,055 ) $ (83,784 ) $ (44,137 ) Share-based compensation expense 1,376 2,403 7,624 7,099 Interest expense 2,778 2,779 11,120 11,122 Interest expense related to the sale of future revenue 62 61 243 236 Interest expense related to royalty obligations 1,433 1,384 5,737 5,459 Interest income and other income, net (1,252 ) (734 ) (4,367 ) (3,437 ) Income taxes benefit — (14 ) — (14 ) Depreciation and amortization 129 147 548 718 Total non-GAAP adjustments $ 4,526 $ 6,026 $ 20,905 $ 21,183 Adjusted EBITDA $ (27,334 ) $ (11,029 ) $ (62,879 ) $ (22,954 ) Excluding one-time legal expenses $ (13,200 ) $ — $ (13,200 ) $ — Adjusted EBITDA excluding one-time legal expenses $ (14,134 ) $ (11,029 ) $ (49,679 ) $ (22,954 ) Excluding adjusted R&D expenses $ (3,355 ) $ (4,474 ) $ (15,256 ) $ (18,995 ) Adjusted EBITDA excluding adjusted R&D expenses and one-time legal expenses $ (10,779 ) $ (6,555 ) $ (34,423 ) $ (3,959 ) AQUESTIVE THERAPEUTICS, INC. Reconciliation of Non-GAAP Adjustments - Total Costs and Expenses to Adjusted Costs and Expenses (In Thousands) (Unaudited) Three Months Ended December 31, Year Ended December 31, 2025 2024 2025 2024 Total costs and expenses $ 41,854 $ 25,446 $ 115,596 $ 88,332 Non-GAAP adjustments: Share-based compensation expense (1,376 ) (2,403 ) (7,624 ) (7,099 ) Depreciation and amortization (129 ) (147 ) (548 ) (718 ) Adjusted costs and expenses $ 40,349 $ 22,896 $ 107,424 $ 80,515 Manufacture and supply expense $ 5,836 $ 4,520 $ 18,555 $ 17,872 Gross Margin on total revenue 55 % 62 % 58 % 69 % Non-GAAP adjustments: Share-based compensation expense (123 ) (103 ) (481 ) (374 ) Depreciation and amortization (103 ) (124 ) (442 ) (606 ) Non-GAAP adjusted manufacture and supply expense $ 5,610 $ 4,293 $ 17,632 $ 16,892 Non-GAAP Gross Margin on total revenue 57 % 64 % 60 % 71 % Research and development expense $ 3,196 $ 4,917 $ 17,192 $ 20,280 Non-GAAP adjustments: Share-based compensation expense 173 (427 ) (1,875 ) (1,215 ) Depreciation and amortization (14 ) (16 ) (61 ) (70 ) Non-GAAP adjusted research and development expense $ 3,355 $ 4,474 $ 15,256 $ 18,995 Selling, general and administrative expenses $ 32,822 $ 16,009 $ 79,849 $ 50,180 Non-GAAP adjustments: Share-based compensation expense (1,426 ) (1,873 ) (5,268 ) (5,510 ) Depreciation and amortization (12 ) (7 ) (45 ) (42 ) Non-GAAP adjusted selling, general and administrative expenses $ 31,384 $ 14,129 $ 74,536 $ 44,628