Aquestive Therapeutics is a specialty pharmaceutical company focused on identifying, developing and commercializing differentiated products to address unmet medical needs.
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WARREN, N.J., Sept. 4, 2018 /PRNewswire/ -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a specialty pharmaceutical company focused on identifying, developing and commercializing differentiated products to address unmet medical needs, today reported financial results for the second quarter ended June 30, 2018 and provided a business update. "Aquestive has advanced its proprietary development pipeline and continues to advance its commercial organization. With the proceeds from our recently closed IPO, we are well positioned to take our late stage CNS products, Sympazan™ and diazepam, to market as they are approved, and to continue our complex molecule development efforts," said Keith J. Kendall, Chief Executive Officer of Aquestive. "Most notably, the tentative approval for Sympazan that we received from the FDA on August 31st is a significant milestone for the company, as well as for the patients and caregivers who seek improved treatment options to manage Lennox-Gastaut Syndrome." Pipeline Overview and Upcoming Milestones Aquestive received tentative approval for Sympazan (clobazam) oral film for the treatment of Lennox-Gastaut Syndrome (LGS) from the U.S. Food and Drug Administration (FDA) in line with its assigned Prescription Drug User Fee Act (PDUFA) date of August 31, 2018. Final FDA approval for Sympazan is pending the expiration of the orphan drug exclusivity period for ONFI ®, which is expected in October 2018. Aquestive completed enrollment for the adult Epilepsy Monitoring Unit (EMU) clinical study for its diazepam oral film formulation and is advancing towards an NDA filing. Recent Business Highlights Aquestive completed its initial public offering of common stock on July 25, 2018 at an offering price of $15.00 per share and received aggregate gross proceeds of $73.9 million, inclusive of the partial exercise of the over-allotment option by the underwriters. Net proceeds received from the offering, after deducting underwriters' discount and fees and expenses of the offering, were $63.5 million. Aquestive's Board of Directors appointed Santo "Sandy" Costa as Chairman in line with its plan. Douglas Bratton, who served as Chairman since 2004, will continue to serve as a member of the Board of Directors. Aquestive also appointed Nancy Lurker, an experienced commercial leader in the pharmaceutical industry, to its Board of Directors. The U.S. District Court for the District of New Jersey granted Aquestive, together with Indivior PLC (LON: INDV) and its U.S. subsidiary, Indivior Inc., a preliminary injunction against Dr. Reddy's Laboratories (DRL), mandating the restrictions of the previously entered temporary restraining order (TRO) remain in place. The preliminary injunction prevents DRL from using, selling, offering to sell, or importing its generic buprenorphine/naloxone sublingual film until further order of the district court or of the appellate court. Second Quarter 2018 Financial Results
As of June 30, 2018, cash and cash equivalents were $10.6 million, as compared to $17.4 million as of December 31, 2017. After June 30, 2018, the company received net proceeds from its IPO of $63.5 million. About Aquestive Therapeutics Forward-Looking Statement 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 the Company's development work, including any delays or changes to the timing, cost and success of our product development activities and clinical trials; the risks of delays in FDA approval of our drug candidates or failure to receive approval; the risks inherent in commercializing a new product (including technology risks, financial risks, market risks and implementation risks and regulatory limitations); development of our sales and marketing capabilities; the rate and degree of market acceptance of our product candidates; the success of any competing products; the size and growth of our product markets; the effectiveness and safety of our product candidates; risks associated with intellectual property rights and infringement; unexpected patent developments; and other risks and uncertainties affecting the Company including those described in the "Risk Factors" section included in our Registration Statement on Form S-1 declared effective by the SEC on July 24, 2018. As with any pharmaceutical product candidate under development, there are significant risks with respect to the development, regulatory approval and commercialization of new products. Given these 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 us or any person acting on our behalf are expressly qualified in their entirety by this cautionary statement. We assume no obligation to update our forward-looking statements after the date of this press release whether as a result of new information, future events or otherwise, except as may be required under applicable law. Media inquiries: Investor inquiries:
AQUESTIVE THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except per membership interest and per share data amounts)
(Unaudited)
Three Months Ended Six months Ended
June 30 June 30
2018 2017 2018 2017
---- ---- ---- ----
$13,928 $11,142 $37,339 $27,577
Revenues
Cost and expenses:
4,973 5,141 10,609 9,325
Manufacture and supply
7,994 4,837 12,895 10,178
Research and development
33,647 5,223 41,216 11,352
Selling, general and administrative
46,614 15,201 64,720 30,855
Total costs and expenses
(32,686) (4,059) (27,381) (3,278)
Loss from operations
Other income (expenses):
(1,927) (1,949) (3,854) (3,767)
Interest expense
(1,859) 111 (1,162) (309)
Change in fair value of warrant
(21) - 3 -
Other, net
(36,493) (5,897) (32,394) (7,354)
Net loss before income taxes
- - - -
Income taxes
(36,493) (5,897) (32,394) (7,354)
Net loss
- (615) - (1,228)
Dividends on redeemable preferred interests
(36,493) (6,512) (32,394) (8,582)
Net loss attributable to common shares / members' interests
$(36,493) $(6,512) $(32,394) $(8,582)
Comprehensive loss
Net loss per share
$(1.90) $(1.89)
Net loss per common share - basic and diluted
19,188,624 17,144,492
Weighted-average number of common shares / membership interests
outstanding - basic and diluted
AQUESTIVE THERAPEUTICS, INC.
Condensed Consolidated Balance Sheets
(in thousands, except unit amounts)
(Unaudited)
June 30, December 31,
2018 2017
---- ----
ASSETS:
Current assets:
$10,638 $17,379
Cash and cash equivalents
6,629 6,179
Accounts receivable, net
4,348 4,014
Inventories, net
5,034 591
Prepaid expenses and other current assets
26,649 28,163
Total current assets
12,766 13,460
Property and equipment, net
229 254
Intangible assets, net
197 1,239
Other assets
$39,841 $43,116
Total assets
LIABILITIES AND SHAREHOLDERS' / MEMBERS' DEFICIT
Current liabilities:
$21,140 $14,003
Accounts payable and accrued expenses
1,234 1,347
Deferred revenue
1,100 -
Loans payable, current
23,474 15,350
Total current liabilities
45,330 45,507
Loans payable, net
8,835 7,673
Warrant liability
1,150 1,081
Asset retirement obligations
78,789 69,611
Total liabilities
Commitments and contingencies (Note 14)
- 5,896
Redeemable preferred A-3 interests and accrued dividends
- 36,205
Redeemable preferred A-2 interests and accrued dividends
Shareholders' /Members' Deficit
Preferred A interests, no par value. Authorized 100,000,000 units;
- 16,887
16,886,750 units issued and outstanding at December 31, 2017
-
Preferred A-1 interests, no par value. Authorized
- 21,883
100,000,000 units; 21,526,850 units issued and outstanding at December 31, 2017
Common interests, no par value. Authorized 500,000,000 units;
- 12,727
121,228,353 units issued and outstanding at December 31, 2017
Common stock, $.001 par value. Authorized 350,000,000 shares;
20 -
15,077,647 voting and 4,922,353 non-voting (Note 15) shares issued and outstanding at June 30, 2018
(6,574) -
Additional paid-in capital
(32,394) (120,093)
Accumulated deficit
(38,948) (68,596)
Total shareholders'/members' deficit
$39,841 $43,116
Total liabilities and shareholders' / members' deficit
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Company Codes: LSE:INDV, OTC-PINK:INVVY, NASDAQ-NMS:AQST |
