Aquestive Therapeutics Reports Second Quarter 2018 Financial Results and Recent Business Highlights, Including Tentative Approval for Sympazan™
"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
Pipeline Overview and Upcoming Milestones
Aquestive received tentative approval for Sympazan (clobazam) oral film for the treatment of Lennox-Gastaut Syndrome (LGS) from the
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
Aquestive's Board of Directors appointed Santo "Sandy" Costa as Chairman in line with its plan.
Second Quarter 2018 Financial Results
- Total revenues increased by 25% to
$13.9 million for the second quarter of 2018, up from$11.1 million reported in the second quarter of 2017. - Manufacturing and supply expenses decreased by 2% to
$5.0 million for the second quarter of 2018 from$5.1 million in the same quarter in 2017. - Research and development expenses increased by 67% to
$8.0 million in the second quarter of 2018 from$4.8 million in the second quarter of 2017. - Selling, general and administrative expenses increased to
$33.6 million in the second quarter of 2018 from$5.2 million in the same quarter in 2017. Included in the 2018 selling, general and administrative expenses was$24.8 million of one-time compensation costs associated with the issuance of the non-voting common shares and related withholding taxes, which the company elected to pay on behalf of its former performance unit holders.
As of
About
Forward-Looking Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "anticipate," "believe," "could," "estimate," "expects," "intend," "may," "plan," "potential," "project," "will," "would," or the negative of those terms, and similar expressions, are intended to identify forward-looking statements. Such statements include, but are not limited to, statements about regulatory approvals and pathways, clinical trial timing and plans, the achievement of clinical and commercial milestones, future financial and operating results, business strategies, market opportunities, financing, and other statements that are not historical facts.
These forward-looking statements are based on our current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Such risks and uncertainties include, but are not limited to: risks associated with 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
Media inquiries:
christopher.hippolyte@syneoshealth.com
212-364-0458
Investor inquiries:
stephanie.carrington@icrinc.com
646-277-1282
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 |
|||||||||||||
2018 |
2017 |
2018 |
2017 |
|||||||||||
Revenues |
$ 13,928 |
$ 11,142 |
$ 37,339 |
$ 27,577 |
||||||||||
Cost and expenses: |
||||||||||||||
Manufacture and supply |
4,973 |
5,141 |
10,609 |
9,325 |
||||||||||
Research and development |
7,994 |
4,837 |
12,895 |
10,178 |
||||||||||
Selling, general and administrative |
33,647 |
5,223 |
41,216 |
11,352 |
||||||||||
Total costs and expenses |
46,614 |
15,201 |
64,720 |
30,855 |
||||||||||
Loss from operations |
(32,686) |
(4,059) |
(27,381) |
(3,278) |
||||||||||
Other income (expenses): |
||||||||||||||
Interest expense |
(1,927) |
(1,949) |
(3,854) |
(3,767) |
||||||||||
Change in fair value of warrant |
(1,859) |
111 |
(1,162) |
(309) |
||||||||||
Other, net |
(21) |
- |
3 |
- |
||||||||||
Net loss before income taxes |
(36,493) |
(5,897) |
(32,394) |
(7,354) |
||||||||||
Income taxes |
- |
- |
- |
- |
||||||||||
Net loss |
(36,493) |
(5,897) |
(32,394) |
(7,354) |
||||||||||
Dividends on redeemable preferred interests |
- |
(615) |
- |
(1,228) |
||||||||||
Net loss attributable to common shares / members' interests |
(36,493) |
(6,512) |
(32,394) |
(8,582) |
||||||||||
Comprehensive loss |
$ (36,493) |
$ (6,512) |
$ (32,394) |
$ (8,582) |
||||||||||
Net loss per share |
||||||||||||||
Net loss per common share - basic and diluted |
$ (1.90) |
$ (1.89) |
||||||||||||
Weighted-average number of common shares / membership interests |
19,188,624 |
17,144,492 |
AQUESTIVE THERAPEUTICS, INC. |
||||||||||
Condensed Consolidated Balance Sheets |
||||||||||
(in thousands, except unit amounts) |
||||||||||
(Unaudited) |
||||||||||
June 30, |
December 31, |
|||||||||
2018 |
2017 |
|||||||||
ASSETS: |
||||||||||
Current assets: |
||||||||||
Cash and cash equivalents |
$ 10,638 |
$ 17,379 |
||||||||
Accounts receivable, net |
6,629 |
6,179 |
||||||||
Inventories, net |
4,348 |
4,014 |
||||||||
Prepaid expenses and other current assets |
5,034 |
591 |
||||||||
Total current assets |
26,649 |
28,163 |
||||||||
Property and equipment, net |
12,766 |
13,460 |
||||||||
Intangible assets, net |
229 |
254 |
||||||||
Other assets |
197 |
1,239 |
||||||||
Total assets |
$ 39,841 |
$ 43,116 |
||||||||
LIABILITIES AND SHAREHOLDERS' / MEMBERS' DEFICIT |
||||||||||
Current liabilities: |
||||||||||
Accounts payable and accrued expenses |
$ 21,140 |
$ 14,003 |
||||||||
Deferred revenue |
1,234 |
1,347 |
||||||||
Loans payable, current |
1,100 |
- |
||||||||
Total current liabilities |
23,474 |
15,350 |
||||||||
Loans payable, net |
45,330 |
45,507 |
||||||||
Warrant liability |
8,835 |
7,673 |
||||||||
Asset retirement obligations |
1,150 |
1,081 |
||||||||
Total liabilities |
78,789 |
69,611 |
||||||||
Commitments and contingencies (Note 14) |
||||||||||
Redeemable preferred A-3 interests and accrued dividends |
- |
5,896 |
||||||||
Redeemable preferred A-2 interests and accrued dividends |
- |
36,205 |
||||||||
Shareholders' /Members' Deficit |
||||||||||
Preferred A interests, no par value. Authorized 100,000,000 units; |
||||||||||
16,886,750 units issued and outstanding at December 31, 2017 |
- |
16,887 |
||||||||
Preferred A-1 interests, no par value. Authorized |
- |
|||||||||
100,000,000 units; 21,526,850 units issued and outstanding at December 31, 2017 |
- |
21,883 |
||||||||
Common interests, no par value. Authorized 500,000,000 units; |
||||||||||
121,228,353 units issued and outstanding at December 31, 2017 |
- |
12,727 |
||||||||
Common stock, $.001 par value. Authorized 350,000,000 shares; |
||||||||||
15,077,647 voting and 4,922,353 non-voting (Note 15) shares issued and outstanding at June 30, 2018 |
20 |
- |
||||||||
Additional paid-in capital |
(6,574) |
- |
||||||||
Accumulated deficit |
(32,394) |
(120,093) |
||||||||
Total shareholders'/members' deficit |
(38,948) |
(68,596) |
||||||||
Total liabilities and shareholders' / members' deficit |
$ 39,841 |
$ 43,116 |
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