November, 06 2018 at 16:02 PM EST

- Completed adult epilepsy monitoring study demonstrating that Libervant™ provides comparable bioavailability
- Received FDA approval for SYMAPAZAN™ for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS)
- Hosts investment community conference call at 4:30 pm ET on November 6th

WARREN, N.J., Nov. 6, 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 third quarter ended September 30, 2018 and provided a business update.

(PRNewsfoto/Aquestive Therapeutics)

"Aquestive is the worldwide leader in delivering therapeutics on oral film with our PharmFilm® technology. Over the past quarter, we have met a number of key business milestones that position us well to achieve our long-term vision for growth," said Keith J. Kendall, Chief Executive Officer of Aquestive. "We are excited to continue advancing our pipeline and building our CNS commercial franchise with the launch of SYMPAZAN. Late stage development of Libervant is also advancing with the recent completion of the adult EMU study."

Pipeline Overview, Upcoming Milestones and Business Update

Aquestive received U.S. FDA approval for SYMPAZAN (clobazam) oral film for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older. SYMPAZAN previously received tentative FDA approval on August 31, 2018 and has now been approved based on the expiration of the orphan drug exclusivity period for ONFI®.

Aquestive completed a pharmacokinetic adult epilepsy monitoring unit (EMU) study demonstrating that its investigational diazepam buccal film (DBF) product candidate, tentatively named Libervant, provides comparable bioavailability whether administered between seizures (interictal) or during and shortly after seizures (ictal/peri-ictal) in adult patients with poorly controlled tonic-clonic seizures or focal seizures with impaired awareness. DBF, a novel formulation of diazepam as a small, thin film strip placed inside the cheek, is under development for the management of selected patients with refractory epilepsy who require intermittent use of diazepam to control episodes of increased seizure activity.

The topline data from the adult EMU study will be presented as two late-breaking poster presentations at the American Epilepsy Society's Annual Meeting, being held from November 30 to December 4, 2018.

Aquestive recently reached agreement with the FDA to end the swallowing study for AQST-117 (riluzole), an oral soluble film formulation for the treatment of Amyotrophic Lateral Sclerosis, the third late-stage CNS asset in its proprietary portfolio, sooner than previously planned based on an analysis of the study's interim data. Topline results are expected to be reported in late 2018 and an NDA submission is expected in the first quarter of 2019. 

Aquestive continues to make progress on its early stage complex molecule development programs for anaphylaxis and acromegaly. The Company expects to commence a Phase 1 proof of concept study during 2019 for AQST-108, its sublingual film formulation of epinephrine in development for the treatment of anaphylaxis. During the third quarter 2018, Aquestive commenced a Phase 1 human proof of concept study for AQST-305, the Company's sublingual formulation of octreotide in development for the treatment of acromegaly.

Aquestive's collaborative partnership development activities continue to advance, and its year-to-date Suboxone volume produced and shipped has risen by 5%. In addition, AQST-119, an oral soluble film formulation of tadalafil, a vasodilator that is used to treat erectile dysfunction, or ED, has its Prescription Drug User Fee Act (PDUFA) date on November 18, 2018 for tentative approval.

Third Quarter 2018 Financials
As of September 30, 2018, Aquestive's cash and cash equivalents were $64.0 million, as compared to $17.4 million as of December 31, 2017. In July 2018, Aquestive received net proceeds from its IPO of $63.5 million.

Aquestive's comprehensive net loss for the third quarter 2018 was $15.0 million, or $0.64 loss per share. The comprehensive net income for the third quarter 2017 was $7.8 million. The increase in net loss in the third quarter 2018 was driven in part by lower revenue in 2018 compared to 2017 due to a $14 million reduction in contractually stipulated collaborative partner license payments. The loss in the third quarter of 2018 period was also impacted by increased total expenses compared to 2017, including from selling, general and administrative expenses that were primarily driven by investments in SYMPAZAN commercialization.

Investment Community Conference Call
Aquestive will host an investment community conference call at 4:30 p.m. ET on Tuesday, November 6, 2018. Investors and analysts may participate in the conference call by dialing (866) 417-5886 from the U.S. and (409) 217-8235 internationally, followed by the conference ID: 3248427. 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 Aquestive Therapeutics
Aquestive Therapeutics is a specialty pharmaceutical company focused on identifying, developing and commercializing differentiated products to address unmet medical needs. Aquestive Therapeutics has a late-stage proprietary product pipeline focused on the treatment of CNS diseases, and is working to advance orally-administered complex molecules that it believes can be alternatives to invasively-administered standard of care therapies. As the leader in developing and delivering drugs via its PharmFilm® technology, Aquestive Therapeutics also collaborates with pharmaceutical partners to bring new molecules to market in differentiated and highly-marketable dosage forms.

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 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 and our other filings with the Securities and Exchange Commission. 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:

Christopher Hippolyte
christopher.hippolyte@syneoshealth.com
212-364-0458

Investor inquiries:

Stephanie Carrington
stephanie.carrington@icrinc.com
646-277-1282

 

 AQUESTIVE THERAPEUTICS, INC. 

 Condensed Consolidated Statements of Operations and Comprehensive (Loss)/Income 

 (In thousands, except per share data) 









 (Unaudited) 






























 Three Months Ended 


 Nine Months Ended 









September 30, 


 September 30, 









2018


2017


2018


2017
















 Revenues 





$         13,267


$        27,146


$         50,606


$         54,723
















 Costs and Expenses: 










 Manufacture and supply 


5,592


4,880


16,201


14,205


 Research and development 


4,534


5,684


17,429


15,862


 Selling, general and administrative 


12,345


6,161


53,561


17,513




Total costs and expenses 


22,471


16,725


87,191


47,580




 (Loss)/income from operations 


(9,204)


10,421


(36,585)


7,143













 Other income (expenses): 










 Interest expense 


(1,933)


(1,970)


(5,809)


(5,737)


 Interest income 


216


-


238


-


 Change in fair value of warrant 


(4,116)


-


(5,278)


(309)


 Other, net 




(1)


-


2


-



 Net (loss)/income before income taxes 


(15,038)


8,451


(47,432)


1,097


 Income taxes 



-


-


-


-



 Net (loss)/income  


(15,038)


8,451


(47,432)


1,097

 Dividends on redeemable preferred interests 


-


(626)


-


(1,854)



 Net (loss)/income  attributable to common 











      shares/members' interests 


$        (15,038)


$          7,825


$        (47,432)


$            (757)


















 Comprehensive net (loss)/income 


$        (15,038)


$          7,825


$        (47,432)


$            (757)
















 Net loss per share - basic and diluted 


$            (0.64)




$            (2.45)


















 Weighted-average number of common shares 










 outstanding - basic and diluted 


23,646,192




19,335,541



 

 

AQUESTIVE THERAPEUTICS, INC.

Condensed Consolidated Balance Sheets

(In thousands, except per share / unit amounts)







(Unaudited)













September 30,


December 31,

Assets


2018


2017












Current assets:







Cash and cash equivalents


$           63,982


$           17,379


Accounts receivable, net


7,450


6,179


Inventories, net


4,483


4,014


Prepaid expenses and other current assets


1,444


591



Total current assets


77,359


28,163

Property and equipment, net


12,211


13,460

Intangible assets, net


216


254

Other assets




224


1,239



Total assets


$           90,010


$           43,116






Liabilities and Shareholders' Equity/Members' Deficit





Current liabilities:






Accounts payable and accrued expenses


$           17,798


$           14,003


Deferred revenue


781


1,347


Loans payable, current


2,750


-



Total current liabilities


21,329


15,350


Loans payable, net


44,054


45,507


Warrant liability


-


7,673


Asset retirement obligations


1,183


1,081



Total liabilities


66,566


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 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 250,000,000 shares;






24,942,185 shares issued and outstanding at September 30, 2018 (Note 15)


25


-


Additional paid-in capital


70,851


-


Accumulated deficit


(47,432)


(120,093)



Total shareholders' equity/members' deficit


23,444


(68,596)



Total liabilities and shareholders' equity/members' deficit


$           90,010


$           43,116

 

 

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SOURCE Aquestive Therapeutics, Inc.