Acute repetitive seizure

Reports full year 2023 revenue of $50.6 million and non-GAAP adjusted EBITDA loss of $11.6 millionReaffirms expected release of topline pivotal clinical data for Anaphylm™ (epinephrine) Sublingual Film in March 2024Reaffirms anticipated FDA decision on Libervant™ (diazepam) Buccal Film application in April 2024Provides full year 2024 financial guidanceHosts investment community conference call on March 6, 2024 WARREN, N.J., March 05, 2024 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ:AQST), 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, 2023, and provided a progress update on the key 2024 objectives previously outlined by the Company. “We ended 2023 on a strong note with double digit base revenue growth, an improved balance sheet, and the start of our pivotal study for Anaphylm. We are now focused on continuing our progress in 2024 and building a strong foundation for the long-term growth of the Company. This includes (1) progressing Anaphylm to a US filing, (2) expanding and growing our revenue base, (3) licensing or launching Libervant (diazepam) Buccal Film, if approved by the FDA with market access, and (4) advancing our next pipeline assets by utilizing our Adrenaverse technology,” stated Daniel Barber, President and Chief Executive Officer of Aquestive. “Anaphylm, as the only orally administered epinephrine product under development for the treatment of severe allergic reactions including anaphylaxis, continues to represent a transformational opportunity for both patients and the Company. We remain excited to see our topline pivotal data and continue to anticipate reporting topline data from our Anaphylm pivotal study this month.” Anaphylm™Aquestive is advancing the development of Anaphylm, the first and only orally delivered epinephrine product candidate to demonstrate clinical results comparable to autoinjectors (such as EpiPen® and Auvi-Q®) for the emergency treatment of allergic reactions, including anaphylaxis. Aquestive received positive feedback in October 2023 from the U.S. Food and Drug Administration (FDA) on the Company's pivotal Phase 3 Pharmacokinetic (PK) clinical protocol for Anaphylm. The FDA indicated that the Company’s proposed endpoints, sample size, and statistical analysis are reasonable. As anticipated, the FDA also reminded the Company that PK sustainability post-dosing (30–60 minutes) is an important factor and recommended using repeat-dose data to support PK sustainability. The Company has incorporated the FDA’s feedback into the design of its clinical protocol for Anaphylm. Aquestive commenced dosing in December 2023 in the Phase 3 pivotal PK clinical study of Anaphylm. The two-part, single-center, open-label, randomized study is designed to compare the PK and pharmacodynamics (PD) of single and repeat doses of Anaphylm versus single and repeat doses of the epinephrine IM injection and epinephrine autoinjectors in healthy adult subjects. The primary objective of the study is to compare the PK of epinephrine following the single administration of Anaphylm to single administration of epinephrine IM injection in healthy adult subjects. The secondary objectives of the study include evaluating PK sustainability following repeat administration and evaluating the safety and tolerability following single and repeat administrations versus epinephrine IM injection and epinephrine autoinjectors. Aquestive anticipates reporting topline data from the Anaphylm Pivotal PK study this month and continuing to guide to a filing of the Anaphylm New Drug Application (NDA) with the FDA before the end of 2024. A comprehensive adult and pediatric Human Factors program, an expected and ongoing part of the Anaphylm clinical development program, will also be included in the Anaphylm NDA to support future labeling and the use of the product by intended patients. Libervant™In September 2023, the FDA accepted Aquestive's NDA for Libervant (diazepam) Buccal Film for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) in patients between two and five years of age. Diastat (diazepam) Rectal Gel is the only FDA approved treatment currently available to this patient population for this indication. Based on the latest information available to the Company, the review of the Libervant NDA remains on track and there are currently no outstanding information requests from the FDA. The NDA for Libervant was assigned a PDUFA target action date of April 28, 2024. The NDA for Libervant for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) in patients twelve years of age and older was tentatively approved by the FDA in August 2022 and is currently subject to an orphan drug market exclusivity block until January 2027 based on an FDA approved nasal spray product of another company. The Company continues to engage with the FDA on Libervant’s approval for U.S. market access and remains committed to bringing Libervant to patients. Commercial CollaborationsAquestive continues to manufacture products for the licensing and supply collaborations that it has established. The Company manufactured approximately 45 million doses in the fourth quarter 2023, compared to approximately 37 million doses in the fourth quarter 2022. The Company continues to see consistent order demand for the manufacture of Indivior’s Suboxone® Sublingual Film product and continues to support its other global collaborations including the recent launch of Emilyf (Riluzole) Oral Film product by Zambon in Europe. 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® for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients six years of age and older continued to improve in the fourth quarter of 2023. Fourth Quarter 2023 FinancialsTotal revenues were $13.2 million in the fourth quarter 2023, compared to $10.7 million in the fourth quarter 2022, an increase of 24%. The increase was due to higher manufacture and supply revenues, and license and royalty revenues, offset by the discontinuance of proprietary product sales of Sympazan as a result of the outlicensing agreement with Assertio in October 2022. Manufacture and supply revenue increased by 23%, or $2.1 million, primarily due to increased manufacturing revenues of $3.2 million for Suboxone partially offset by decreases for Ondif® for Hypera in Brazil and for Sympazan. In addition, the Company recognized $1.0 million in milestone royalty revenue for Azstarys from Zevra Therapeutics. Aquestive’s net loss for the fourth quarter 2023 was $8.1 million, or $0.12 loss per share. The net loss for the fourth quarter 2022 was $12.4 million, or $0.23 loss per share. The reduction in net loss was primarily driven by increases in revenue described above, decreases in selling, general and administrative expense, including severance costs and lower administrative costs in the commercial organization subsequent to the outlicensing of Sympazan, and a decrease in research and development cost and expenses, partially offset by increases by a one-time loss on extinguishment of debt of $1.0 million and higher interest expense related to the amortization of debt discount related to the 13.5% Notes payable. Non-GAAP adjusted EBITDA loss was $2.8 million in the fourth quarter 2023, compared to a $9.6 million loss in the fourth quarter 2022. Non-GAAP adjusted EBITDA loss excluding adjusted R&D expenses was $0.1 million in the fourth quarter 2023, compared to a non-GAAP adjusted EBITDA loss excluding adjusted R&D expenses of $5.6 million in the fourth quarter 2022. Full Year 2023 FinancialsExcluding the impact of prior year proprietary sales of Sympazan, total revenues increased from $40.0 million for the full year 2022 to $50.6 million for the full year 2023, an increase of 26%. The increase was due to higher manufacture and supply revenues and license and royalty revenue offset by the discontinuance of proprietary product sales of Sympazan following the outlicensing of Sympazan. Total reported revenues were $50.6 million for the full year 2023, compared to $47.7 million for the full year 2022, an increase of 6%. Manufacture and supply revenue increased 20% due to increased manufacturing revenues of $4.4 million for Suboxone, increased revenues of $2.1 million for Ondif for Hypera subsequent to receiving foreign regulatory approval in February 2022, and increased revenues of $0.6 million for Sympazan. License and royalty revenue increased 129%, or $3.0 million, for the year ended December 31, 2023 compared to the same period in 2022. This increase was primarily due to $1.5 million in milestone licensing revenues for Azstarys from Zevra Therapeutics and increased licensing and royalty revenue of $1.3 million for Sympazan. The Company’s net loss for the full year 2023 was $7.9 million, or $0.13 loss per share. The net loss for the full year 2022 was $54.4 million, or $1.12 loss per share. The reduction in net loss was primarily driven by $14.5 million of other income which consisted of $6.0 million from an amendment to the Indivior Commercial Exploitation Agreement, and $8.5 million from the patent litigation settlement with BioDelivery Sciences International, increases in revenue described above, decrease in selling, general and administrative expense, including severance costs and significantly lower administrative costs in the commercial organization subsequent to the outlicensing of Sympazan, a decrease in research and development cost and expenses and lower interest expense related to the KYNMOBI® monetization transaction, partially offset by a loss on extinguishment of debt of $1.4 million and higher interest expense related to the amortization of debt discount related to the 13.5% Notes payable. Non-GAAP adjusted EBITDA loss was $11.6 million in the full year 2023, compared to a loss of $35.3 million in the full year 2022. The year-over-year change in non-GAAP adjusted EBITDA was primarily driven by the items described above. Non-GAAP adjusted EBITDA income excluding adjusted R&D expenses was $1.0 million in the full year 2023, compared to a non-GAAP adjusted EBITDA loss excluding adjusted R&D expenses of $18.7 million in the full year 2022. As of December 31, 2023, cash and cash equivalents were $23.9 million.  During the fourth quarter 2023, the Company accessed capital net proceeds of $3.7 million under its "At-the-Market" (ATM) facility. 2024 Outlook Aquestive is providing its full year 2024 financial outlook. The Company expects: GuidanceTotal revenue (in millions)$48 to $51Non-GAAP adjusted EBITDA loss (in millions)$22 to $26 Revenue guidance does not include any revenue for Libervant. In addition, the guidance for 2024 includes continued focused R&D investments related to the continued development and planned NDA filing of Anaphylm. Tomorrow’s Conference Call and Webcast ReminderThe Company will host a conference call at 8:00 a.m. ET on Wednesday, March 6, 2024. 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 Aquestive’s website: Fourth Quarter 2023 Earnings Call. The webcast will be archived for 30 days. About Aquestive TherapeuticsAquestive is a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies. We are developing orally administered products to deliver complex molecules, providing novel alternatives to invasive and inconvenient standard of care therapies. Aquestive has five commercialized products marketed by its licensees in the U.S. and around the world and is the exclusive manufacturer of these licensed products. The Company also collaborates with pharmaceutical companies to bring new molecules to market using proprietary, best-in-class technologies, like PharmFilm®, and has proven drug development and commercialization capabilities. Aquestive is advancing a late-stage proprietary product pipeline focused on treating diseases of the central nervous system and an earlier stage pipeline for the treatment of severe allergic reactions, including anaphylaxis. For more information, visit Aquestive.com and follow us on LinkedIn. Non-GAAP Financial InformationThis 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 adjusted R&D 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 income (loss) for loss on the extinguishment of debt; 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 (expense), net and income taxes, with a result of adjusted EBITDA loss.  Similarly, manufacture and supply expense, research and development 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, research and development 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 StatementCertain 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 through clinical development and approval by the FDA, including receipt and release of topline data and the filing of the Anaphylm NDA; regarding the FDA’s approval and related timing of the filing of the NDA for Libervant with the FDA 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 between two and five years of age; regarding the approval for U.S. market access of Libervant for these epilepsy patients aged two years and older; overcoming the orphan drug market exclusivity of an FDA approved nasal spray product of another company extending to January 2027 for this patient population; regarding the potential benefits Anaphylm and Libervant could bring to patients; regarding the potential growth in market demand for existing licensed products of the Company in the U.S. and abroad and the potential and related timing for expanding the Company’s manufacturing capabilities and supporting the growth of demand for existing and potential future licensed products in the U.S. and other countries; regarding the financial outlook of the Company and its growth and future financial and operating results and financial position; regarding advancing the Company's pipeline assets utilizing the Company's Adrenaverse technology through clinical development and regulatory approval; and other statements that are not historical facts. These forward-looking statements are subject to the uncertain impact of the COVID-19 global pandemic on the Company’s business including with respect to its clinical trials including site initiation, enrollment and timing and adequacy of clinical trials; on regulatory submissions and regulatory reviews and approval of Anaphylm and Libervant and the Company's other pipeline products, pharmaceutical ingredients and other raw materials supply chain, manufacture, and distribution; and ongoing availability of an appropriate labor force and skilled professionals. These forward-looking statements are based on the Company’s 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 the Company’s development work, including any delays or changes to the timing, cost and success of its product development activities and clinical trials for Anaphylm, Libervant and our other product candidates; risk of the Company’s ability to generate sufficient data in its PK/PD comparability submission for FDA approval of Anaphylm; risk of the Company’s ability to address the FDA’s comments on the Company’s pivotal PK study protocol and other concerns identified in the FDA End-of-Phase 2 meeting for Anaphylm, including the risk that the FDA may require additional clinical studies for approval of Anaphylm; risk of delays in or the failure to receive FDA approval of Anaphylm; risks that the FDA will not approve Libervant for U.S. market access by overcoming the seven year orphan drug market exclusivity of an FDA approved nasal spray product of another company in effect until January 2027; risk of delays in or the failure to receive FDA approval of the NDA for Libervant for these epilepsy patients between two and five years of age, including the risk that the FDA may require additional clinical studies for approval of Libervant for this age group, and there can be no assurance that the Company will be successful in obtaining any of the foregoing FDA approvals for Anaphylm and Libervant, including for U.S. market access for Libervant for any age group of patients; risk that a competing pediatric epilepsy product of Libervant will receive FDA approval prior to the Company’s receipt of FDA approval of the Libervant NDA for these epilepsy patients between two and five years of age; risk relating to the unpredictability of the FDA’s decisions regarding orphan drug exclusivity; risk of litigation brought by third parties relating to overcoming their orphan drug exclusivity of an FDA approved product should the FDA approve Libervant for U.S. market access for any age group of this epilepsy patient population; risk in obtaining market access for Libervant for other reasons; risks associated with the Company’s development work, including any delays or changes to the timing, cost and success of the Company’s product development activities; risk of the success of any competing products; risk inherent in commercializing a new product (including technology risks, financial risks, market risks and implementation risks, and regulatory limitations); risk of the rate and degree of market acceptance of our product candidates, including Anaphylm and Libervant, and our licensed products in the U.S. and abroad; risk of insufficient capital and cash resources, including insufficient access to available debt and equity financing and revenues from operations, to satisfy all of the Company’s short-term and longer term liquidity and cash requirements and other cash needs, at the times and in the amounts needed, including to fund future clinical development activities for Anaphylm, Libervant and our other product candidates; risk of failure to satisfy all financial and other debt covenants and of any default under existing debt financing; risk that our manufacturing capabilities will be sufficient to support demand for existing and potential future licensed products in the U.S. and other countries; risk of eroding market share for Suboxone® and risk as a sunsetting product, which accounts for the substantial part of our current operating revenue; risk of the size and growth of our product markets; risks of 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 the Company's products; risk of unexpected patent developments; uncertainties related to general economic, political (including acts of war and terrorism), business, industry, regulatory, financial and market conditions and other unusual items; and other risks and uncertainties affecting the Company described in the “Risk Factors” section and in other sections included in the Company’s 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®, 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:ICR WestwickeStephanie Carringtonstephanie.carrington@westwicke.com646-277-1282 AQUESTIVE THERAPEUTICS, INC.Consolidated Balance Sheets(In thousands, except share and per share amounts)(Unaudited) December 31, 2023 2022Assets Current assets: Cash and cash equivalents$23,872 $27,273 Trade and other receivables, net 8,471 4,704 Inventories, net 6,769 5,780 Prepaid expenses and other current assets 1,854 2,131 Total current assets 40,966 39,888 Property and equipment, net 4,179 4,085 Right-of-use assets, net 5,557 5,211 Intangible assets, net 1,278 1,435 Other non-current assets 5,438 6,451 Total assets$57,418 $57,070 Liabilities and stockholders’ deficit Current liabilities: Accounts payable$8,926 $9,946 Accrued expenses 6,497 7,967 Lease liabilities, current 390 255 Deferred revenue 1,551 1,513 Liability related to the sale of future revenue, current 922 1,147 Loans payable, current 22 18,700 Total current liabilities 18,308 39,528 Loans payable, net 27,508 33,448 Royalty obligations, net 14,761 — Liability related to the sale of future revenue, net 63,568 64,112 Lease liabilities 5,399 5,085 Deferred revenue, net of current portion 32,345 31,417 Other non-current liabilities 2,016 2,034 Total liabilities 163,905 175,624 Contingencies Stockholders’ deficit: Common stock, $0.001 par value. Authorized 250,000,000 shares; 68,533,085 and 54,827,734 shares issued and outstanding at December 31, 2023 and December 31, 2022, respectively 69 55 Additional paid-in capital 212,521 192,598 Accumulated deficit (319,077) (311,207)Total stockholders’ deficit (106,487) (118,554)Total liabilities and stockholders’ deficit$57,418 $57,070 AQUESTIVE THERAPEUTICS, INC.Consolidated 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, 2023 2022 2023 2022Revenues$13,206 $10,682 $50,583 $47,680 Costs and expenses: Manufacture and supply 4,679 5,305 20,831 19,386 Research and development 2,888 4,278 13,104 17,481 Selling, general and administrative 9,550 11,812 31,750 52,879 Total costs and expenses 17,117 21,395 65,685 89,746 Loss from operations (3,911) (10,713) (15,102) (42,066)Other income (expenses): Interest expense (2,273) (1,650) (6,337) (6,552)Interest expense related to royalty obligations (905) — (905) — Interest expense related to the sale of future revenue (57) (54) (220) (5,891)Interest income and other income, net 165 65 16,321 99 Loss on the extinguishment of debt (1,029) — (1,382) — Net loss before income taxes (8,010) (12,352) (7,625) (54,410)Income taxes (101) — (245) — Net loss$(8,111) $(12,352) $(7,870) $(54,410)Comprehensive loss$(8,111) $(12,352) $(7,870) $(54,410) Net loss per share – basic and diluted$(0.12) $(0.23) $(0.13) $(1.12) Weighted-average number of common shares outstanding - basic and diluted 67,199,645 54,390,696 61,255,864 48,734,377 AQUESTIVE THERAPEUTICS, INC.Reconciliation of Non-GAAP Adjustments - Net Loss to Adjusted EBITDA(In Thousands)(Unaudited) Three Months Ended December 31, Year Ended December 31, 2023 2022 2023 2022GAAP net loss$(8,111) $(12,352) $(7,870) $(54,410)Share-based compensation expense 923 712 2,689 4,381 Interest expense 2,273 1,650 6,337 6,552 Interest expense related to the sale of future revenue 57 54 220 5,891 Interest expense related to royalty obligations 905 — 905 — Interest income and other income (expense), net (165) (65) (16,321) (99)Income taxes (101) — (245) — Depreciation, amortization, and impairment 433 397 1,345 2,387 Loss on extinguishment of debt 1,029 — 1,382 — Total non-GAAP adjustments$5,354 $2,748 $(3,688) $19,112 Adjusted EBITDA$(2,757) $(9,604) $(11,558) $(35,298)Excluding adjusted R&D expenses$(2,688) $(3,975) $(12,557) $(16,636)Adjusted EBITDA excluding adjusted R&D expenses$(69) $(5,629) $999 $(18,662) AQUESTIVE THERAPEUTICS, INC.Reconciliation of Non-GAAP Adjustments - Total Costs and Expenses to Adjusted Costs and Expenses(In Thousands)(Unaudited) Three Months EndedDecember 31, Year EndedDecember 31, 2023 2022 2023 2022Total costs and expenses$17,117 $21,395 $65,685 $89,746 Non-GAAP adjustments: Share-based compensation expense (923) (712) (2,689) (4,381)Depreciation, amortization, and impairment (433) (397) (1,345) (2,387)Adjusted costs and expenses$15,761 $20,286 $61,651 $82,978 Manufacture and supply expense$4,679 $5,305 $20,831 $19,386 Gross Margin on total revenue 65% 50% 59% 59%Non-GAAP adjustments: Share-based compensation expense (36) (44) (191) (203)Depreciation, amortization, and impairment (395) (317) (1,140) (1,890)Adjusted manufacture and supply expense$4,248 $4,944 $19,500 $17,293 Non-GAAP Gross Margin on total revenue 68% 54% 61% 64% Research and development expense$2,888 $4,278 $13,104 $17,481 Non-GAAP adjustments: Share-based compensation expense (179) (266) (456) (672)Depreciation, amortization, and impairment (21) (37) (91) (173)Adjusted research and development expense$2,688 $3,975 $12,557 $16,636 Selling, general and administrative expenses$9,550 $11,812 $31,750 $52,879 Non-GAAP adjustments: Share-based compensation expense (708) (402) (2,042) (3,506)Depreciation, amortization, and impairment (17) (43) (79) (324)Adjusted selling, general and administrative expenses$8,825 $11,367 $29,629 $49,049

Investor call to feature presentations from Leslie Lucien Citrome, MD, MPH, Issam Awad, MD, FACS and Connie Lee, PsyD SAN DIEGO, Feb. 26, 2024 /PRNewswire/ -- Neurelis, Inc. today announced it will host an investor call to highlight updates on two of its neuroscience product development candidates, NRL-1004 for acute agitation episodes and NRL-1049 for cerebral cavernous malformations (CCMs). The investor call will be held virtually on Thursday, March 7, 2024 at 10:30 AM ET. To register, click here. Agenda Topics NRL-1004 for Acute Agitation Episodes – 10:30 am - 11:15 am ET NRL-1004, an investigational nasal spray formulation of olanzapine and Neurelis proprietary Intravail® technology, for the treatment of acute agitation episodes, featuring Leslie Lucien Citrome, MD, MPH (New York Medical College, SUNY Upstate Medical University, Icahn School of Medicine at Mount Sinai). NRL-1049 for Cerebral Cavernous Malformations – 11:15 am - 12:00 pm ET NRL-1049, an investigational, Phase 1, new chemical entity, Rho kinase (ROCK) inhibitor, for the treatment of cerebral cavernous malformations (CCMs), featuring Issam Awad, MD, MSc, FACS, MA (University of Chicago Medicine) and Connie Lee, PsyD (Alliance to Cure Cavernous Malformation) Presentations will include overviews of the disease state, unmet need, and current treatment landscape for patients, as well as a discussion of the potential differentiating features of Neurelis' product candidates. A live question and answer session will follow the formal presentations of both segments. About Leslie Lucien Citrome, MD, MPH Leslie Lucien Citrome, MD, MPH is Clinical Professor of Psychiatry and Behavioral Sciences at New York Medical College in Valhalla, New York, Clinical Professor of Psychiatry at SUNY Upstate Medical University, and Adjunct Clinical Professor of Psychiatry, Icahn School of Medicine at Mount Sinai in New York City, New York. He is a Distinguished Life Fellow of the American Psychiatric Association and a Fellow of the American Society of Clinical Psychopharmacology where he currently serves as Immediate Past-President. In addition to his academic positions, he has a private practice in psychiatry in Pomona, New York and is a volunteer consultant to the Assertive Community Treatment team/Mental Health Association of Rockland County. Dr. Citrome obtained his MD degree from the McGill University Faculty of Medicine in 1983 and his MPH degree from the Columbia School of Public Health in 1996. His immediate prior position was as the founding Director of the Clinical Research and Evaluation Facility at the Nathan S. Kline Institute for Psychiatric Research in Orangeburg, New York, where he worked from 1994 through 2010 and achieved the rank of Professor of Psychiatry at the New York University School of Medicine. Dr. Citrome is currently a consultant in clinical trial design and interpretation. He is a frequent lecturer on the quantitative assessment of clinical trial results, including the metrics of number needed to treat and number needed to harm, and has lectured throughout the Americas, Europe, Asia, and Australasia. His main interests include schizophrenia, bipolar disorder, and major depressive disorder. He is author or coauthor of over 600 research reports, reviews, and chapters in the scientific literature. He is a member of the Board of Directors of the World Association of Medical Editors. Dr. Citrome is editor-in-chief of Current Medical Research and Opinion (CMRO) published by Taylor & Francis, editor emeritus, International Journal of Clinical Practice where he was editor-in-chief 2013-2019; psychiatry topic editor for Clinical Therapeutics; editor for the American Society of Clinical Psychopharmacology Corner in the Journal of Clinical Psychiatry; section editor for psychopharmacology for Current Psychiatry; and also serves as an editorial board member for several other medical journals. About Issam Awad, MD, FACS Issam Awad, MD, MSc, FACS, MA is the John Harper Seeley Professor of Neurological Sciences at the University of Chicago. He leads the Neurovascular Surgery Program, co-leads the Stroke and Neurovascular Care team at UChicago Medicine, and Directs of the Safadi Program of Excellence in Clinical and Translational Neuroscience and the first accredited Center of Excellence for Cerebral Cavernous Malformations (CCM) in the U.S. His research focuses on vascular biology, genetics and comprehensive outcome analysis in neurovascular disease and stroke, and his active projects include National Institutes of Health and department of Defense funded investigations of molecular mechanisms involved in the formation and progression of cerebrovascular malformations. Additionally, he leads several clinical trials on minimally invasive techniques for surgical treatment of hemorrhagic stroke and novel drug therapies for Cavernous Angiomas with Symptomatic Hemorrhage (CASH). Dr. Awad's scientific innovations include the characterization of subcortical ischemic lesions in the aged, advances in the understanding of the natural history and biologic behavior of cerebral vascular malformations and numerous technical advances in neurovascular and epilepsy surgery. He has authored leading textbooks and published more than 350 scholarly papers related to clinical innovations, surgical outcomes and research. He has also served as president of the Congress of Neurological Surgeons, chairman of the Cerebrovascular Section of the American Association of Neurological Surgeons and Congress of Neurological Surgeons, and on the executive committee of the American Stroke Association and the board of governors of the American College of Surgeons. He served on the U.S. National Council for Neurological Disorders and Stroke and is the founding chairman of the Scientific Advisory Board of the Alliance to Cure Cavernous Malformation. About Connie Lee, PsyD Connie Lee, PsyD is the founding President of the Alliance to Cure Cavernous Malformation. Connie is a licensed clinical psychologist and the mother of a daughter with multiple cavernous malformations. Connie's personal story with cavernous malformation began in January 2000. At that time, Connie's 4-month-old daughter Julia received brain surgery for a major hemorrhage and hydrocephalus caused by a cavernous malformation. Dr. Lee founded Angioma Alliance, the original name of the Alliance to Cure, in 2002. She has guided the organization from its beginnings as a support group to its current role as the driving force for research, legislation, and patient care. About Neurelis Neurelis, Inc., is a neuroscience company focused on the development and commercialization of therapeutics for the treatment of epilepsy and orphan neurologic disorders characterized by high unmet medical needs. In 2020, the FDA approved Neurelis' VALTOCO® (diazepam nasal spray) as an acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from an individual's usual seizure pattern in adult and pediatric patients 6 years of age and older. VALTOCO is a proprietary formulation of diazepam incorporating the science of INTRAVAIL®. For more information on VALTOCO, please visit . For more information on Neurelis. please visit . For the latest scientific information on VALTOCO, please visit . Contacts: Neurelis: Brittany Bradrick, Chief Operating Officer and Chief Financial Officer, +1 858 251 2100 Media: Glenn Silver, FINN Partners, +1 646 871 8485

Study presents new persistence analysis of FINTEPLA, evaluating the efficacy and tolerability of FINTEPLA over a span of 12 months1 Real-world data looks into the need for resources to support caregivers – both parents and siblings – of people living with developmental and epileptic encephalopathies such as Dravet and Lennox-Gastaut syndromes in the transition from pediatric to long-term adult care2 Systematic literature review underscores the need for more impactful conversations between patients, caregivers and clinicians about sudden unexpected death in epilepsy (SUDEP)3 These research and findings demonstrate UCB's commitment to symptom management as well as holistic patient care ATLANTA, Dec. 2, 2023 /PRNewswire/ -- UCB, a global biopharmaceutical company, today announced data being presented at the American Epilepsy Society (AES) Annual Meeting, taking place December 1–5 in Orlando, Florida, that focus on the real-world experiences of people living with rare epilepsy syndromes and their caregivers, in addition to several other presentations of clinical data evaluating the efficacy, safety and tolerability of FINTEPLA as a treatment for seizures associated with Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS). Continue Reading Fintepla® (fenfluramine) 2.2 mg/mL oral solution) People living with a severe group of rare epilepsies called developmental and epileptic encephalopathies (DEEs), including DS and LGS, experience frequent and prolonged seizures, significant behavioral and developmental delays, movement and balance issues, and sleep difficulties.4 These ongoing challenges can create significant obstacles for both patients and their caregivers, as the conditions often require consistent and lifelong management to mitigate the dangerous side effects and detrimental impacts on quality of life.5 "It is critical to address not only seizures but also the non-seizure outcomes that can severely impact overall quality of life for people living with rare epilepsies and their caregivers," said Brad Chapman, Head of U.S. Epilepsy and Rare Syndromes at UCB. "The robust data being presented at AES reflect UCB's commitment to research and resources that support the rare epilepsy community. By continuing to deepen our understanding of the real-world experiences faced by people living with rare epilepsy syndromes (acute repetitive seizures and focal epilepsy), we will be able to better support their journey to finding appropriate treatment options faster and provide resources and education over the long term." The real-world evidence being presented at AES supports the need to integrate the lived experiences of the rare epilepsy community into the development of treatment options and resources, to bring more holistic care to people living with rare epilepsies and their caregivers. "Providing proactive education and counseling for people living with rare epilepsy syndromes and their caregivers is critical for improving seizure control, appropriate treatment adherence and management of risks like SUDEP," said Tom Stanton, President of the Danny Did Foundation and study investigator. "To achieve effective communication, neurologists need support to help them initiate difficult discussions about potentially negative impacts on quality of life. With the proper tools, providers can play a big role to empower and inform patients and caregivers." The real-world data on fenfluramine, long-term care planning for rare epilepsy syndrome patients, and SUDEP counselling being presented at AES include: A 12-Month Persistence Analysis of Fenfluramine, Valproate, and Levetiracetam in Individuals with Dravet Syndrome: A Comparison Using U.S. Claims Data1 A new analysis utilizing U.S. real-world data of fenfluramine in people living with DS.1 Data from this late-breaking poster presentation featured U.S. healthcare claims data from Komodo Healthcare showing the persistency of fenfluramine – defined as the duration of continuous treatment without a gap of more than 90 days.1 A Survey of Rare Epilepsy Parents and Adult Siblings: To Assess Resources Needed to Prepare Families Living in the U.S. for Long-term Adult Care Planning for Their Loved One2 Survey assessed resources and needs required for caregivers' long-term care planning for a family member diagnosed with a developmental and epileptic encephalopathy (DEE). 2 Data from a survey of 135 caregivers of people with rare epilepsy syndromes, including parents and adult siblings, found that only 22% believed they had adequate access to long-term care planning information, while 53% did not have information available to them, and 24% were unsure. Those surveyed cited frustration in finding support and resources for patients with rare epilepsy syndromes and concern about how patients and their caregivers will be supported as they transition into adulthood.2 No family support programs or resources currently exist for long-term adult care planning or for the transfer of primary care for those living with rare epilepsy syndromes, uncovering a significant unmet need for additional support to facilitate future medical, legal and financial planning and ensure caregivers have access to resources and support at every step of their care journey.2 Bridging The Gap Between Neurologists and People with Epilepsy/Caregivers: Systematic Literature R eview about SUDEP Conversations3 Research looks to understand and learn more about caregivers' needs and experiences and neurologists' attitudes and behaviors toward SUDEP conversations. 3 A critical element of care for people living with epilepsy and rare epilepsy syndromes is the continuous management of risk related to sudden unexpected death in epilepsy (SUDEP), a leading disease-related cause of mortality among people living with epilepsy, affecting approximately one in 1,000 adults with epilepsy yearly6 and one in 150 for those with inadequate seizure control.7 A systematic literature review of studies found a gap between what people living with epilepsy and their caregivers want regarding information about SUDEP and the information shared with them by their neurologists.3 While many neurologists reported not actively discussing SUDEP to avoid causing fear or negative emotions, data show that patients and caregivers want to have more proactive discussions about SUDEP to provide them with the opportunity to take preventive measures. Increasing education for people with epilepsy and their caregivers about SUDEP, as well as providing neurologists with support and training to become adept at initiating these difficult discussions, are critical to help build a trusting partnership to enhance epilepsy management and, in turn, reduce the risks of SUDEP.3 In addition to the other accepted posters at AES, UCB will present additional clinical data on FINTEPLA. Click here to learn more. About Epilepsy Epilepsy is a common neurological condition worldwide and affects approximately 50 million people.8 Epilepsy and seizures can develop in any person at any age9 and is usually diagnosed after a person has had at least two seizures (or after one seizure with a high risk for more) that were not caused by some known medical condition.10 About UCB in Epilepsy For three decades, we've been committed to people living with epilepsy and their families, surrounding the patient and caregiver through every step of their care journey. At our core, we have a responsibility to elevate the healthcare ecosystem. Because of this, we have established our legitimacy on the front lines of epilepsy research, development, and treatment innovation. But our past breakthroughs are only a prologue to our future. We will continue to reimagine how we care for patients, leveraging today's expertise for a better tomorrow. With so much experience behind us and so much potential ahead, we are more invested than ever in profoundly improving the lives of those living with or caring for those with epilepsy or a rare epilepsy syndrome – through our relentless pursuit of a seizure-free life. About FINTEPLA® (fenfluramine) Oral Solution 11 FINTEPLA is indicated for the treatment of seizures associated with Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS) in patients 2 years of age and older. FINTEPLA is available only through a restricted distribution program called the FINTEPLA REMS. Further information is available at or by telephone at +1 877 964 3649. IMPORTANT SAFETY INFORMATION BOXED WARNING: VALVULAR HEART DISEASE and PULMONARY ARTERIAL HYPERTENSION There is an association between serotonergic drugs with 5-HT2B receptor agonist activity, including fenfluramine (the active ingredient in FINTEPLA), and valvular heart disease and pulmonary arterial hypertension. Echocardiogram assessments are required before, during, and after treatment with FINTEPLA. FINTEPLA is available only through a restricted program called the FINTEPLA REMS. CONTRAINDICATIONS FINTEPLA is contraindicated in patients with hypersensitivity to fenfluramine or any of the excipients in FINTEPLA and with concomitant use, or within 14 days of the administration, of monoamine oxidase inhibitors because of an increased risk of serotonin syndrome. WARNINGS AND PRECAUTIONS Valvular Heart Disease and Pulmonary Arterial Hypertension (see Boxed Warning): Because of the association between serotonergic drugs with 5-HT2B receptor agonist activity, including fenfluramine (the active ingredient in FINTEPLA), and valvular heart disease (VHD) and pulmonary arterial hypertension (PAH), cardiac monitoring via echocardiogram is required prior to starting treatment, during treatment, and after treatment with FINTEPLA concludes. Cardiac monitoring via echocardiogram can aid in early detection of these conditions. In clinical trials for DS and LGS of up to 3 years in duration, no patient receiving FINTEPLA developed VHD or PAH. Monitoring: Prior to starting treatment, patients must undergo an echocardiogram to evaluate for VHD and PAH. Echocardiograms should be repeated every 6 months, and once at 3-6 months post treatment with FINTEPLA. The prescriber must consider the benefits versus the risks of initiating or continuing treatment with FINTEPLA if any of the following signs are observed via echocardiogram: valvular abnormality or new abnormality; VHD indicated by mild or greater aortic regurgitation or moderate or greater mitral regurgitation, with additional characteristics of VHD (eg, valve thickening or restrictive valve motion); PAH indicated by elevated right heart/pulmonary artery pressure (PASP >35 mmHg). FINTEPLA REMS Program (see Boxed Warning): FINTEPLA is available only through a restricted distribution program called the FINTEPLA Risk Evaluation and Mitigation Strategy (REMS) Program. Prescribers must be certified by enrolling in the FINTEPLA REMS. Prescribers must counsel patients receiving FINTEPLA about the risk of VHD and PAH, how to recognize signs and symptoms of VHD and PAH, the need for baseline (pretreatment) and periodic cardiac monitoring via echocardiogram during FINTEPLA treatment, and cardiac monitoring after FINTEPLA treatment. Patients must enroll in the FINTEPLA REMS and comply with ongoing monitoring requirements. The pharmacy must be certified by enrolling in the FINTEPLA REMS and must only dispense to patients who are authorized to receive FINTEPLA. Wholesalers and distributors must only distribute to certified pharmacies. Further information is available at or by telephone at 1-877-964-3649. Decreased Appetite and Decreased Weight: FINTEPLA can cause decreases in appetite and weight. Decreases in weight appear to be dose related. Approximately half of the patients with LGS and most patients with DS resumed the expected measured increases in weight during the open-label extension studies. Weight should be monitored regularly during treatment with FINTEPLA, and dose modifications should be considered if a decrease in weight is observed. Somnolence, Sedation, and Lethargy: FINTEPLA can cause somnolence, sedation, and lethargy. Other central nervous system (CNS) depressants, including alcohol, could potentiate these effects of FINTEPLA. Prescribers should monitor patients for somnolence and sedation and should advise patients not to drive or operate machinery until they have gained sufficient experience on FINTEPLA to gauge whether it adversely affects their ability to drive or operate machinery. Suicidal Behavior and Ideation: Antiepileptic drugs (AEDs), including FINTEPLA, increase the risk of suicidal thoughts or behaviors in patients taking these drugs for any indication. Patients treated with an AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behaviors, or any unusual changes in mood or behavior. Anyone considering prescribing FINTEPLA or any other AED must balance the risk of suicidal thoughts or behaviors with the risks of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behaviors. Should suicidal thoughts and behaviors emerge during treatment, consider whether the emergence of these symptoms in any given patient may be related to the illness being treated. Withdrawal of Antiepileptic Drugs: As with most AEDs, FINTEPLA should generally be withdrawn gradually because of the risk of increased seizure frequency and status epilepticus. If withdrawal is needed because of a serious adverse reaction, rapid discontinuation can be considered. Serotonin Syndrome: Serotonin syndrome, a potentially life-threatening condition, may occur with FINTEPLA, particularly during concomitant administration of FINTEPLA with other serotonergic drugs, including, but not limited to, selective serotonin-norepinephrine reuptake inhibitors (SNRIs), selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants (TCAs), bupropion, triptans, dietary supplements (eg, St. John's Wort, tryptophan), drugs that impair metabolism of serotonin (including monoamine oxidase inhibitors [MAOIs], which are contraindicated with FINTEPLA), dextromethorphan, lithium, tramadol, and antipsychotics with serotonergic agonist activity. Patients should be monitored for the emergence of signs and symptoms of serotonin syndrome, which include mental status changes (eg, agitation, hallucinations, coma), autonomic instability (eg, tachycardia, labile blood pressure, hyperthermia), neuromuscular signs (eg, hyperreflexia, incoordination), and/or gastrointestinal symptoms (eg, nausea, vomiting, diarrhea). If serotonin syndrome is suspected, treatment with FINTEPLA should be stopped immediately and symptomatic treatment should be started. Increase in Blood Pressure: FINTEPLA can cause an increase in blood pressure. Rare cases of significant elevation in blood pressure, including hypertensive crisis, has been reported in adult patients treated with fenfluramine, including patients without a history of hypertension. In clinical trials for DS and LGS of up to 3 years in duration, no pediatric or adult patient receiving FINTEPLA developed hypertensive crisis. Monitor blood pressure in patients treated with FINTEPLA. Glaucoma: Fenfluramine can cause mydriasis and can precipitate angle closure glaucoma. Consider discontinuing treatment with FINTEPLA in patients with acute decreases in visual acuity or ocular pain. ADVERSE REACTIONS The most common adverse reactions observed in DS studies (incidence at least 10% and greater than placebo) were decreased appetite; somnolence, sedation, lethargy; diarrhea; constipation; abnormal echocardiogram; fatigue, malaise, asthenia; ataxia, balance disorder, gait disturbance; blood pressure increased; drooling, salivary hypersecretion; pyrexia; upper respiratory tract infection; vomiting; decreased weight; fall; status epilepticus. The most common adverse reactions observed in the LGS study (incidence at least 10% and greater than placebo) were diarrhea; decreased appetite; fatigue; somnolence; vomiting. DRUG INTERACTIONS Strong CYP1A2, CYP2B6, or CYP3A Inducers: Coadministration with strong CYP1A2, CYP2B6, or CYP3A inducers will decrease fenfluramine plasma concentrations. If coadministration of a strong CYP1A2, CYP2B6, or CYP3A inducer with FINTEPLA is necessary, monitor the patient for reduced efficacy and consider increasing the dosage of FINTEPLA as needed. If a strong CYP1A2, CYP2B6, or CYP3A inducer is discontinued during maintenance treatment with FINTEPLA, consider gradual reduction in the FINTEPLA dosage to the dose administered prior to initiating the inducer. Strong CYP1A2 or CYP2D6 Inhibitors: Coadministration with strong CYP1A2 or CYP2D6 inhibitors will increase fenfluramine plasma concentrations. If FINTEPLA is coadministered with strong CYP1A2 or CYP2D6 inhibitors, the maximum daily dosage of FINTEPLA is 20 mg. If a strong CYP1A2 or CYP2D6 inhibitor is discontinued during maintenance treatment with FINTEPLA, consider gradual increase in the FINTEPLA dosage to the dose recommended without CYP1A2 or CYP2D6 inhibitors. If FINTEPLA is coadministered with stiripentol and a strong CYP1A2 or CYP2D6 inhibitor, the maximum daily dosage of FINTEPLA is 17 mg. USE IN SPECIFIC POPULATIONS In patients with severe impairment of kidney function (estimated glomerular filtration rate [eGFR]) 15 to 29 mL/min/1.73m2, dosage adjustments are recommended. FINTEPLA has not been studied in patients with kidney failure (eGFR <15 mL/min/1.73m2). Combined molar exposures of fenfluramine and norfenfluramine were increased in subjects with various degrees of hepatic impairment (Child-Pugh Class A, B, and C), necessitating a dosage adjustment in these patients. To report SUSPECTED ADVERSE REACTIONS, contact UCB, Inc. at 1‑844-599-2273 or FDA at 1-800-FDA-1088 or . Please see full Prescribing Information , including Boxed Warning and Medication Guide , for additional Important Safety Information on FINTEPLA. For further information, contact UCB: Corporate Communications Becky Malone, U.S. Media Relations T +919.605.9600 [email protected] Investor Relations Antje Witte T +32.2.559.9414 [email protected] About UCB UCB, Brussels, Belgium () is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 8,600 people in approximately 40 countries, the company generated revenue of € 5.8 billion in 2021. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCBUSA. References Jaganathan S, et al. A 12-month persistence analysis of fenfluramine, valproate, and levetiracetam in individuals with Dravet Syndrome: a comparison using US claims data. Poster presented at American Epilepsy Society Annual Meeting; December 1-5, 2023; Orlando, Florida. Laurie D Bailey, et al. A Survey of Rare Epilepsy Parents and Adult Siblings: To Assess Resources Needed to Prepare Families Living in the U.S. for Long-term Adult Care Planning for Their Loved. Abstract presented at American Epilepsy Society Annual Meeting; December 1-5, 2023; Orlando, Florida. Luker J, et al. Bridging the gap between neurologists and people with epilepsy/caregivers: systematic literature review about SUDEP conversations. Poster presented at American Epilepsy Society Annual Meeting; December 1-5, 2023; Orlando, Florida. Epilepsy Foundation. Developmental and Epileptic Encephalopathy (DEE). Available at: . Accessed November 2023. Salom R, Aras LM, Piñero J, Duñabeitia JA. The psychosocial impact of caring for children with Dravet Syndrome. Epilepsy Behav Rep. 2023;24:100619. Harden C, et al. Practice guideline summary: Sudden unexpected death in epilepsy incidence rates and risk factors: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology and the American Epilepsy Society. Neurology. 2017;88:1674-1680. Child Neurology Foundation. SUDEP. Available at: . Accessed November 2023. Meyer AC, Dua T, Ma J, et al. Global disparities in the epilepsy treatment gap: a systemic review. Bull World Health Organ. 2010;88: 260-266. Epilepsy Foundation. Who Can Get Epilepsy? Available at: . Accessed November 2023. Epilepsy Foundation: What is Epilepsy? Available at: . Accessed November 2023. FINTEPLA (fenfluramine) oral solution: U.S. prescribing information. Smyrna, GA: UCB, Inc. FINTEPLA® is a registered trademark of the UCB Group of Companies. ©2023 UCB, Inc., Smyrna, GA 30080. All rights reserved. US-FA-2300166 SOURCE UCB