Aquestive Therapeutics Exceeds Top End of Guidance Range for Preliminary Unaudited Full Year 2019 Total Revenues and Provides Initial Full Year 2020 Guidance
- Anticipates full year 2019 preliminary unaudited total revenues to be approximately
$52 million , exceeding previously provided full year revenue guidance - Anticipates fourth quarter 2019 preliminary unaudited total revenues to be approximately
$16 million - Expects preliminary unaudited cash and cash equivalents as of
December 31, 2019 of approximately$49 million - Provides initial full year 2020 anticipated financial guidance
“In addition to exceeding the top end of our revenue guidance, we achieved significant milestones, as promised, in 2019. First, we completed our rolling submission of the New Drug Application (NDA) for our therapeutic candidate Libervant™ (diazepam) Buccal Film for the management of seizure clusters to the
Preliminary Unaudited 2019 Total Revenues and Cash Position
Preliminary unaudited total revenues are anticipated to be approximately
Preliminary unaudited cash and cash equivalents as of
Initial Full Year 2020 Financial Guidance
Aquestive is providing initial full year 2020 financial guidance as follows based upon the assumptions outlined below:
- Total revenues of approximately
$35 million to $45 million - Supply of branded Suboxone at similar volumes to fourth quarter 2019, representing a market share of approximately 48%, and implemented product price adjustments, but no further meaningful volumes from the discontinued
Sandoz authorized generic product - Expected revenues from Sympazan net sales, co-development programs, and license fees and royalties from licensed products
- Excludes any net revenues from Libervant as there can be no guaranty of approval or commercialization
- Supply of branded Suboxone at similar volumes to fourth quarter 2019, representing a market share of approximately 48%, and implemented product price adjustments, but no further meaningful volumes from the discontinued
- Non-GAAP adjusted gross margins of approximately 70% to 75% on total revenues
- Reflective of the anticipated higher profitability of Suboxone manufacturing revenues and expected greater mix of higher margin proprietary revenue
- Non-GAAP adjusted EBITDA loss of approximately
$65 million to $70 million - Reflective of anticipated more profitable revenue and significant cost rationalization in the company’s plant and other legacy aspects of the business, offset by expected substantially higher investments in R&D driven by AQST-108 and preparation for the anticipated launch of Libervant
- Cash burn of approximately
$65 million to $70 million after considering interest, capital spending and working capital effects, but prior to any additional capital transactions.
Aquestive expects to report fourth quarter and full year 2019 audited results on
About
Non-GAAP Outlook
In providing outlook for non-GAAP adjusted gross margins and non-GAAP adjusted EBITDA, we exclude certain items which are otherwise included in determining the comparable GAAP financial measures. 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
This press release includes 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 may include, but are not limited to, statements regarding therapeutic benefits and plans and objectives for regulatory approvals of Libervant and our other product candidates; ability to obtain
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 and plans; risk of delays in
PharmFilm®, Sympazan® and the Aquestive logo are registered trademarks of
SYMPAZAN IMPORTANT SAFETY INFORMATION
BOXED WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS
Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.
- Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.
- Limit dosages and durations to the minimum required.
- Follow patients for signs and symptoms of respiratory depression and sedation.
CONTRAINDICATIONS
SYMPAZAN is contraindicated in patients with a history of hypersensitivity to the drug or its ingredients. Hypersensitivity reactions have included serious dermatological reactions.
WARNINGS AND PRECAUTIONS
Potentiation of Sedation from Concomitant Use with Central Nervous System (CNS) Depressants
SYMPAZAN has a CNS depressant effect. Caution patients and/or caregivers against simultaneous use with other CNS depressants or alcohol as the effects of other CNS depressants or alcohol may be potentiated.
Somnolence or Sedation
SYMPAZAN causes dose-related somnolence and sedation, which generally begins within the first month of treatment and may diminish with continued treatment. Monitor patients for somnolence and sedation, particularly with concomitant use of other CNS depressants. Caution patients against engaging in hazardous activities requiring mental alertness, i.e., operating dangerous machinery or motor vehicles, until the effect of SYMPAZAN is known.
Withdrawal Symptoms
Abrupt discontinuation of SYMPAZAN should be avoided. The risk of withdrawal symptoms is greater with higher doses. Withdraw SYMPAZAN gradually to minimize the risk of precipitating seizures, seizure exacerbation, or status epilepticus.
Serious Dermatological Reactions
Serious skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported with clobazam in both children and adults. Discontinue SYMPAZAN at the first sign of rash, unless the rash is clearly not drug-related.
Physical and Psychological Dependence
Patients with a history of substance abuse should be under careful surveillance when receiving SYMPAZAN.
Suicidal Behavior and Ideation
AEDs, including SYMPAZAN, increase the risk of suicidal thoughts or behavior in patients. Patients treated with SYMPAZAN should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Inform patients, their caregivers, and families of the increased risk of suicidal thoughts and behaviors. Advise them to be alert for and report immediately to healthcare providers any emergence or worsening signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts of self-harm.
ADVERSE REACTIONS
Adverse reactions (≥10% and more frequently than placebo) included constipation, somnolence or sedation, pyrexia, lethargy, and drooling.
DRUG INTERACTIONS
The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression. Limit dosage and duration of concomitant use of benzodiazepines and opioids and follow patients closely for respiratory depression and sedation. Concomitant use of SYMPAZAN with other CNS depressants, including alcohol, may increase the risk of sedation and somnolence. Caution patients and/or caregivers against simultaneous use with other CNS depressants or alcohol, as effects of other CNS depressants or alcohol may be potentiated.
Hormonal contraceptives that are metabolized by CYP3A4; effectiveness may be diminished when given with SYMPAZAN. Additional non-hormonal forms of contraception are recommended when using SYMPAZAN. Dose adjustment may be necessary of drugs metabolized by CYP2D6 and of SYMPAZAN when co-administered with strong CYP2C19 inhibitors (e.g., fluconazole, fluvoxamine, ticlopidine).
USE IN SPECIFIC POPULATIONS
Pregnancy and Lactation: SYMPAZAN may cause fetal harm and should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have taken benzodiazepines during the later stages of pregnancy can develop dependence, withdrawal syndrome and symptoms suggestive of floppy infant syndrome. SYMPAZAN is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from SYMPAZAN, discontinue nursing or discontinue the drug. Encourage patients to call the toll-free number 1-888-233-2334 to enroll in the Pregnancy Registry or visit http://www.aedpregnancyregistry.org/.
You are encouraged to report negative side effects of prescription drugs to the
Please click here to see full Prescribing Information, including the Boxed Warning.
Investor inquiries:
stephanie.carrington@icrinc.com
646-277-1282
Source: Aquestive Therapeutics, Inc.