Aquestive Therapeutics Reports First Quarter 2021 Financial Results and Provides Business Update
- On track to refile Libervant™ (diazepam) Buccal Film New Drug Application (NDA) by end of second quarter 2021
- Initiated first-in-human Phase 1 pharmacokinetic (PK) study for AQST-109 epinephrine sublingual film candidate
- Sympazan® (clobazam) continues to meet key performance metrics and gain market share
- Hosts conference call at
8:00 a.m. ET onMay 5, 2021
“We are focused on continuing to make progress this year in advancing our proprietary products. In response to feedback from the FDA, we are developing additional analyses of the existing clinical data in the NDA for Libervant and expect to refile by the end of the second quarter of 2021. We recently initiated the first-in-human Phase 1 PK study with our second generation epinephrine candidate AQST-109 and anticipate reporting top-line data in the second half of the year,” said
Libervant™
Libervant is a buccally, or inside of the cheek, administered soluble film formulation of diazepam, a benzodiazepine intended for rapid treatment of acute uncontrolled seizures in selected, refractory patients with epilepsy on stable regimens of AEDs who require intermittent use of diazepam to control bouts of increased seizure activity. The Company is developing Libervant as an alternative to more invasive, inconvenient, and difficult to administer device driven products, including a rectal gel, for patients with refractory epilepsy. As a result of these issues, a large portion of the patient population does not receive adequate treatment or foregoes treatment altogether. The Company believes that Libervant, if approved by the FDA for U.S. market access, will enable a larger share of these patients to receive more appropriate treatment by providing consistent therapeutic dosing in a non-invasive and innovative treatment form.
The Company previously received a Complete Response Letter (CRL) from the FDA in
Epinephrine
Aquestive continues to advance its two product candidates, AQST-108 and AQST-109, for the potential treatment of severe allergic reactions, including anaphylaxis, utilizing Aquestive’s PharmFilm® technologies. In late
Sympazan®
Despite the continued limitations on provider in-person interactions caused by the COVID-19 pandemic, the Company’s proprietary product Sympazan® (clobazam), an oral film for the treatment of seizures associated with Lennox-Gastaut syndrome, continues to meet key performance metrics. Shipment volume has grown 13% sequentially quarter over quarter and 40% year over year. Sympazan saw continued growth in the prescriber base, with over 30% penetration into the Company’s focused group of prescribers, with approximately 80% of those prescribers writing multiple prescriptions.
First Quarter 2021 Financials
Total revenues were
Aquestive’s net loss for the first quarter 2021 was
As of
2021 Outlook
Aquestive is maintaining its full year 2021 financial outlook.
The Company expects:
- Total revenues of approximately
$38 million to$42 million - Non-GAAP adjusted gross margins of approximately 70% to 75% on total revenues
- Non-GAAP adjusted EBITDA loss of approximately
$42 million to$45 million
Tomorrow’s Conference Call and Webcast Reminder
The Company will host a conference call at
There will also be a simultaneous, live webcast available on the Investors section of the Company’s website at https://investors.aquestive.com/events-and-presentations. The webcast will be archived for 30 days.
About
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
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. We 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 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 2021 and 2020 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, we adjust for non-cash share-based compensation expense and depreciation and amortization. We are 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 are “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 clinical advancement and related timing of Libervant, AQST-108 and AQST-109 through the regulatory and development pipeline; the focus on growing the Company’s commercial sales of Sympazan®; ability to address the concerns identified in the FDA’s Complete Response Letter dated
These forward-looking statements are also 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 the Company's development work, including any delays or changes to the timing, cost and success of our product development activities and clinical trials and plans for AQST-108, AQST-109 and our other drug candidates; risk of delays in regulatory advancement through the FDA of Libervant, AQST-108, AQST-109 and our other drug candidates or failure to receive approval; risk of our ability to demonstrate to the FDA “clinical superiority” within the meaning of the FDA regulations of our drug candidate Libervant relative to FDA-approved diazepam rectal gel and nasal spray products including by establishing a major contribution to patient care within the meaning of FDA regulations relative to the approved products as well as risks related to other potential pathways or positions which are or may in the future be advanced to the FDA to overcome the seven year orphan drug exclusivity granted by the FDA for the approved nasal spray product of a competitor in the
______________________________________________________________________________________________________
PharmFilm®, Sympazan® and the Aquestive logo are registered trademarks of
Investor inquiries:
Westwicke, an
stephanie.carrington@westwicke.com
646-277-1282
Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
(Unaudited)
2021 |
2020 |
||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 27,498 | $ | 31,807 | |||
Trade and other receivables, net | 10,209 | 6,955 | |||||
Inventories, net | 2,799 | 2,461 | |||||
Prepaid expenses and other current assets | 3,937 | 3,402 | |||||
Total current assets | 44,443 | 44,625 | |||||
Property and equipment, net | 6,279 | 6,873 | |||||
Right-of-use assets, net | 3,277 | 3,448 | |||||
Intangible assets, net | 89 | 102 | |||||
Other non-current assets | 7,835 | 7,836 | |||||
Total assets | $ | 61,923 | $ | 62,884 | |||
Liabilities and stockholders’ deficit | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 6,687 | $ | 7,089 | |||
Accrued expenses | 6,371 | 8,569 | |||||
Lease liabilities, current | 787 | 728 | |||||
Deferred revenue, current | 437 | 693 | |||||
Liability related to the sale of future revenue, current | 1,905 | 1,450 | |||||
Loans payable, current | 3,863 | 2,575 | |||||
Total current liabilities | 20,050 | 21,104 | |||||
Loans payable, net | 34,193 | 34,329 | |||||
Liability related to the sale of future revenue, net | 50,383 | 47,524 | |||||
Lease liabilities | 2,635 | 2,846 | |||||
Deferred revenue, net of current portion | 4,699 | 3,633 | |||||
Other non-current liabilities | 1,761 | 1,945 | |||||
Total liabilities | 113,721 | 111,381 | |||||
Stockholders’ deficit: | |||||||
Common stock, 34,569,254 shares issued and outstanding at respectively |
36 | 35 | |||||
Additional paid-in capital | 149,095 | 137,725 | |||||
Accumulated deficit | (200,929 | ) | (186,257 | ) | |||
Total stockholders’ deficit | (51,798 | ) | (48,497 | ) | |||
Total liabilities and stockholders’ deficit | $ | 61,923 | $ | 62,884 |
Condensed Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share data amounts)
(Unaudited)
Three Months Ended |
||||||||||
2021 | 2020 | |||||||||
Revenues | $ | 11,122 | $ | 8,765 | ||||||
Costs and expenses: | ||||||||||
Manufacture and supply | 2,757 | 3,659 | ||||||||
Research and development | 3,659 | 4,354 | ||||||||
Selling, general and administrative | 13,231 | 14,613 | ||||||||
Total costs and expenses | 19,647 | 22,626 | ||||||||
Loss from operations | (8,525 | ) | (13,861 | ) | ||||||
Other income/(expenses): | ||||||||||
Interest expense | (2,761 | ) | (2,771 | ) | ||||||
Interest expense related to the sale of future revenue, net | (3,334 | ) | — | |||||||
Interest income and other income (expense), net | (52 | ) | 102 | |||||||
Net loss before income taxes | (14,672 | ) | (16,530 | ) | ||||||
Income taxes | — | — | ||||||||
Net loss | $ | (14,672 | ) | $ | (16,530 | ) | ||||
Comprehensive loss | $ | (14,672 | ) | $ | (16,530 | ) | ||||
Net loss per share - basic and diluted | $ | (0.41 | ) | $ | (0.49 | ) | ||||
Weighted-average number of common shares outstanding - basic and diluted | 35,563,275 | 33,569,694 |
Reconciliation of Non-GAAP Adjustments - Net Loss to Adjusted EBITDA
(In Thousands)
(Unaudited)
Three Months Ended |
||||||||
2021 | 2020 | |||||||
GAAP net loss | $ | (14,672 | ) | $ | (16,530 | ) | ||
Share-based Compensation Expense | 1,507 | 1,860 | ||||||
Interest expense | 2,761 | 2,771 | ||||||
Interest expense related to the sale of future revenue, net | 3,334 | — | ||||||
Interest income and other income (expense), net | 52 | (102 | ) | |||||
Depreciation and Amortization | 755 | 766 | ||||||
Income Taxes | — | — | ||||||
Total non-GAAP adjustments | $ | 8,409 | $ | 5,295 | ||||
Adjusted EBITDA | $ | (6,263 | ) | $ | (11,235 | ) |
Reconciliation of Non-GAAP Adjustments - GAAP Expenses to Adjusted Expenses
(In Thousands)
(Unaudited)
Three Months Ended |
||||||||
2021 | 2020 | |||||||
Total costs and expenses | $ | 19,647 | $ | 22,626 | ||||
Non-GAAP adjustments: | ||||||||
Share-based compensation expense | (1,507 | ) | (1,860 | ) | ||||
Depreciation and amortization | (755 | ) | (766 | ) | ||||
Adjusted costs and expenses | $ | 17,385 | $ | 20,000 |
Reconciliation of Non-GAAP Adjustments - GAAP Manufacture & Supply Expense to Adjusted Manufacture and Supply Expense
(In Thousands, except percentages)
(Unaudited)
Three Months Ended |
||||||||
2021 | 2020 | |||||||
Manufacture and Supply Expense | $ | 2,757 | $ | 3,659 | ||||
Gross Margin on total revenue | 75 | % | 58 | % | ||||
Non-GAAP adjustments: | ||||||||
Share-based compensation expense | (82 | ) | (63 | ) | ||||
Depreciation and amortization | (585 | ) | (627 | ) | ||||
Adjusted manufacture and supply expense | $ | 2,090 | $ | 2,969 | ||||
Non-GAAP Gross Margin on total revenue | 81 | % | 66 | % |
Reconciliation of Non-GAAP Adjustments -
(In Thousands)
(Unaudited)
Three Months Ended |
||||||||
2021 | 2020 | |||||||
Research and Development Expense | $ | 3,659 | $ | 4,354 | ||||
Non-GAAP adjustments: | ||||||||
Share-based compensation expense | (232 | ) | (182 | ) | ||||
Depreciation and amortization | (57 | ) | (60 | ) | ||||
Adjusted research and development expense | $ | 3,370 | $ | 4,112 |
Reconciliation of Non-GAAP Adjustments - GAAP Selling, General and Administrative Expenses to Adjusted Selling, General and
Administrative Expenses
(In Thousands)
(Unaudited)
Three Months Ended |
||||||||
2021 | 2020 | |||||||
Selling, General and Administrative Expenses | $ | 13,231 | $ | 14,613 | ||||
Non-GAAP adjustments: | ||||||||
Share-based compensation expense | (1,193 | ) | (1,615 | ) | ||||
Depreciation and amortization | (113 | ) | (79 | ) | ||||
Adjusted selling, general and administrative expenses | $ | 11,925 | $ | 12,919 |
Source: Aquestive Therapeutics, Inc.