Libervant™In September 2023, the FDA accepted the NDA of the oral film Aquestive for Libervant (diazepam) for the acute treatment of intermittent and stereotyped episodes of common seizures (i. e. , group seizures, repetitive acute seizures) in patients two to five years of age. Diastat rectal gel (diazepam) is the only recently FDA-approved drug available for this patient population for this indication. Based on the most recent data that has been received from the Company, Libervant’s NDA review is still underway and there are no notable requests for data from the FDA lately. The NDA for Libervant has been assigned a PDUFA target action date of April 28, 2024.
Libervant’s NDA for the acute treatment of intermittent and stereotyped episodes of common seizures (i. e. , cluster seizures, repetitive acute seizures) in patients twelve years of age and older was provisionally approved by the FDA in August 2022 and is currently subject to an orphan drug. Blocking market exclusivity until January 2027 based on an FDA-approved nasal spray product and some other company.
The company continues to collaborate with the FDA on the approval of Libervant for the U. S. market and remains committed to bringing Libervant to patients.
Business PartnershipsAquestive continues to manufacture products for the licensing and procurement partnerships it has established. The company manufactured approximately forty-five million doses in the fourth quarter of 2023, compared to approximately 37 million doses in the fourth quarter of 2022. The company continues to see constant requests for orders for the production of Indivior’s Suboxone® sublingual film and continues its other global operations. Collaborations, adding the recent product launch of Oral Film Emilyf (Riluzole) through Zambon in Europe.
Fourth Quarter 2023 Financial Data Total profit of $13. 2 million in the fourth quarter of 2023, compared to $10. 7 million in the fourth quarter of 2022, an increase of 24%. The increase is due to higher production and source profits, as well as licensing. and royalty earnings, offset by the halt in sales of Sympazan’s proprietary products following the licensing agreement with Assertio in October 2022.
Manufacturing and procurement earnings increased 23%, or $2. 1 million, primarily due to a higher production gain of $3. 2 million for Suboxone, offset by declines for Ondif®, Hypera in Brazil and Sympazan.
In addition, the company received $1. 0 million in milestone royalty benefits for Azstarys from Zevra Therapeutics.
Aquestive’s net loss for the fourth quarter of 2023 was $8. 1 million, or a loss of $0. 12 consistent with the stake. Net loss for the fourth quarter of 2022 $12. 4 million, or a loss of $0. 23 consistent with participation. The net loss relief is primarily due to the accrual of the revenues described above, minimizing selling, general and administrative expenses, adding severance and minimizing administrative expenses in the advertising organization as a result of the Sympazan license, and minimizing study and progression expenses, partially offset through an accrual of a one-time debt extinguishment loss of $1. 0 million and an accrual of expenses for interest similar to the amortization of the debt reduction of the notes to 13. 5%.
Fiscal Year 2023 Financial Results Excluding the effect of Sympazan’s exclusive sales in the prior year, overall earnings accrual increased from $40. 0 million for full year 2022 to $50. 6 million for full year 2023, an increase of 26%. was driven by increased production and source profits, as well as licensing and royalty earnings, offset by the discontinuation of sales of Sympazan’s proprietary products as a result of Sympazan’s licensing.
Total reported profit was $50. 6 million for the full year 2023, compared to $47. 7 million for all of 2022, an increase of 6%.
Accumulation of manufacturing and procurement earnings increased 20% due to a $4. 4 million accumulation in production earnings for Suboxone, a $2. 1 million accrual in earnings for Ondif for Hypera following foreign regulatory approval in February 2022, and a $0. 6 million accrual in earnings for Sympazan.
Revenue from licenses and royalties increased 129%, or $3. 0 million, for the year ended December 31, 2023, to the same time in 2022. This accumulation is primarily due to $1. 5 million in profits from historic licenses for Azstarys from Zevra Therapeutics and the construction of upd. Licenses and Royalties. Earnings of $1. 3 million for Sympazan.
The non-GAAP adjusted EBITDA loss was $11. 6 million for the full year 2023, compared to a loss of $35. 3 million for the full year 2022. The year-over-year increase in non-GAAP Adjusted EBITDA was primarily due to the factors described above. . Non-GAAP Adjusted EBITDA Earnings R Expenses
As of December 31, 2023, money and cash equivalents amounted to $23. 9 million. During the fourth quarter of 2023, the Company accessed capital income of $3. 7 million through its Market Facility (ATM).
Outlook for 2024
Aquestive provides its monetary outlook for the full year 2024. The Company expects to:
Tomorrow’s Conference Call & Webcast Reminder The company will host a convention at 8:00 a. m. m. ET Wednesday, March 6, 2024.
To participate, log in advance here to get a local or toll-free phone number and your non-public PIN.
A live webcast of the call will be held on the Aquestive website: Fourth Quarter 2023 Earnings Call. The webcast will be archived for 30 days.
About Aquestive TherapeuticsAquestive is a pharmaceutical company that promotes medicines to bring meaningful improvements to patients’ lives through cutting-edge clinical and delivery technologies. We expanded orally administered products to deliver complex molecules, providing new opportunities for invasive and inconvenient popular therapies. Aquestive owns five products advertised through its licensees in the U. S. It is the exclusive manufacturer of those authorized products. The company also collaborates with pharmaceutical corporations to commercialize new molecules that employ state-of-the-art proprietary technologies, such as PharmFilm®, and has demonstrated drug progression and commercialization capabilities. Aquestive is advancing a line of late-stage proprietary products aimed at the treatment of diseases of the central nervous system and an early-stage line for the treatment of severe allergic reactions, including anaphylaxis. To learn more, visit Aquestive. com and stay with us on LinkedIn.
Specifically, the Company adjusts the source of income (loss) net for the loss on extinguishment of debt; certain non-cash expenses, in addition to stock-based reimbursement expenses; depreciation and amortization; and interest expense similar to the sale of a long-term source of income, a source of interest income, and other sources of income (expense), net and taxes on the source of income, resulting from an adjusted EBITDA loss. Similarly, production and sourcing expenses, studies and progression expenses and selling, general and administrative expenses have been adjusted for certain non-cash expenses similar to redemption and share-based depreciation and amortization. Adjusted EBITDA loss and those non-GAAP expense categories are used in addition to the corresponding GAAP measures to obtain further data on the Company’s ongoing operating performance.
These measures complement the Company’s GAAP-ready currency effects. Aquestive Control uses those metrics to analyze its monetary effects, long-term production and procurement expenses, gross margins, studio and progression expenses, and selling, general and administrative expenses and to aid in decision-making. In Control’s opinion, these non-GAAP measures provide greater transparency about Aquestive’s operational functionality and a greater understanding of the effectiveness of our operational methods and actions. The Company may offer one or more adjusted earnings measures for certain discrete items, such as earned fees on certain authorized products, to provide investors with more information about our earnings streams and their distribution, while also offering our earnings GAAP. These measures are intended to complement, not replace, comparable GAAP measures and do not deserve to be construed as a measure of liquidity for Aquestive. Loss of adjusted EBITDA and other non-GAAP measures are also likely calculated in a manner that is not comparable to titled measures reported through other companies.
Non-GAAP Outlook
In providing the outlook for non-GAAP adjusted EBITDA and non-GAAP gross margin, we exclude certain items that are otherwise included in the calculation of comparable GAAP financial measures. To inform our forward-looking measures of non-GAAP adjusted EBITDA and non-GAAP gross margin, a description of the changes that were applicable in calculating non-GAAP adjusted EBITDA and non-GAAP gross margin for those periods is reflected in the tables. . below. By providing a non-GAAP gross margin perspective, the Company adjusts for non-cash share-based payment expenses and depreciation and amortization. The Company provides such outlooks only on a non-GAAP basis, as it cannot expect with moderate certainty the latest total or final results or the occurrence of such changes for the prospective period, such as share-based payment expense, source of taxes on income, depreciation and certain other adjusted items, which could involve long-term events that may not be reliable and expected. Based on past published effects, where one or more of those pieces were applicable, those excluded pieces would likely be important, separately or together, for the purposes presented.
These forward-looking statements are based on the Company’s existing expectations and ideals and are subject to a number of threats and uncertainties that may also cause actual effects to differ materially from those described in the forward-looking statements. These threats and uncertainties include, but are not limited to, relevant threats with the Company’s progression work, including any delays or adjustments in the timing, burden and good fortune of its product progression activities and clinical trials for Anaphylm, Libervant and our other product candidates; the threat to the Company’s ability to generate sufficient knowledge in its PK/PD comparison submission for FDA approval of Anaphylm; the threat to the company’s ability to respond to FDA comments on the company’s pivotal pharmacokinetic study protocol and other known considerations at the end of the FDA’s Phase 2 for Anaphylm, adding that it understood the risk that The FDA may require more clinical studies for approval of Anaphylm. ; threat of delays or failure to discharge FDA approval for Anaphylm; threats that the FDA will not approve Libervant’s access to the US market by exceeding the seven-year orphan drug market exclusivity of another company’s FDA-approved nasal spray product, effective through January 2027; threat of delay or failure to discharge FDA approval of the NDA for Libervant for those elderly epilepsy patients aged two to five years, adding the threat that the FDA will possibly require further clinical studies for approval of Libervant for this age organization, and there can be no guarantee that the Company will be successful in discharging any of the previous FDA approvals for Anaphylm and Libervant, adding US market access for Libervant for patients of any age. ; the threat that a competing pediatric epilepsy product from Libervant will receive FDA approval before the company has obtained FDA approval for Libervant’s NDA for those epilepsy patients between two and five years of age; similar threat to the unpredictability of FDA decisions related to orphan drug exclusivity; threat of third-party litigation regarding exceeding its orphan drug exclusivity of an FDA-approved product if the FDA approves Libervant’s access to the US market for any age organization in this epilepsy patient population ; the threat of Libervant dumping market access for other reasons; relevant threats to the Company’s development work, including any delays or adjustments in the timing, load and good fortune of the Company’s product development activities; threat of good luck from any competing product; the threat inherent to the commercialization of a new product (adding technological threats, monetary threats, market threats and implementation threats, as well as regulatory limitations); the threat of the rate and degree of market acceptance of our product candidates, including Anaphylm and Libervant, and our licensed products in the United States and abroad; threat of insufficient capital and cash resources, in addition to insufficient access to debt and equity financing and operating income, to meet all of the company’s short- and long-term liquidity and cash flow needs. Company monetary and other needs, at times and in amounts necessary, aggregated to fund the long-term clinical progression activities of Anaphylm, Libervant and our other product candidates; the threat of default on all monetary and other debt obligations and any default on existing debt financing; the threat that our manufacturing functions will be sufficient to require existing and potential long-term licensed products in the United States and other countries; the threat of Suboxone® market percentage erosion and the threat of it being a dying product, which represents the truly large portion of our existing operating revenues; similar threat to the longevity and expansion of our product market; threats of compliance with all FDA and other government and visitor needs for our manufacturing facilities; relevant threats with intellectual asset rights and infringement claims related to the Company’s products; threat of unforeseen patent progressions; uncertainties similar to general economic, political (adding acts of war and terrorism), commercial, industrial, regulatory, monetary and market situations and other unusual elements; and other threats and uncertainties affecting the Company described in “Risk Factors” and other sections included in the 10-K Reports, the Quarterly Reports on Form 10-Q and the Current Reports on Form 8-K filed with the U. S. Securities and Exchange Commission Given such uncertainties, you should not place undue reliance on such forward-looking statements, which speak only as of the date on which they are made. All forward-looking statements attributable to the Company or any user acting on its behalf are expressly qualified in their entirety by this cautionary statement. The Company undertakes no legal responsibility to update any forward-looking statements, outlook or guidance after the date of this press release, whether as a result of new information, long-term developments or otherwise, unless required to do so. the applicable law.
PharmFilm®, Sympazan® and the Aquestive logo are registered by Aquestive Therapeutics, Inc. All others referenced herein are assets of their respective owners.
Investor Inquiries: ICR WestwickeStephanie Carringtonstephanie. carrington@westwicke. com646-277-1282