on Thank us for everyone this you, And to the Stephanie. joining you thank morning. call
the our We'll and April the provide I In remarks, John the during leadership session Aquestive afterward. Q&A for of by during update will quarter be on XXXX. business and an team joined members our additional first
a the the company key and the safety Our business priorities as of always patients with, do we and with interact our colleagues, who start caregivers with products. people our
period, to to as a best while continue safe, business, that that to we advance leaders ability, all taking managers we of and as ensure extraordinary important this have of the company. During well work to of responsibility our steps the people the keep
products FDA and proprietary review product, including key manufacturing Aquestive to produce company's continues its its patients, the business initiatives, product elements the company's key including that The such licensee chronic-use has be continue, that of healthy, medicines for facility processes managed business sure colleagues safe company's are SYMPAZAN, all R&D needed our as and manufacturing. Suboxone. and carefully to
in shutdown from resulting in and for with particular. step Protection the this crisis has an our to government Plan, unforeseen by keep production several Act partnering through working or took colleagues the of inventory suppliers key COVID-XX. months we CARES chain available Paycheck funds our and accessing through important the supply PPP, forward, access an the event to early April, In of company The of and going
public company, establishing To Administration Small issued for we as that need, guidance be revised of viewed a Business the later, regardless that no weeks would loan. however, our disappointment, a strong almost eligible two PPP presumption
made decision our include possibly we that of for criteria of new program, second focus qualification, IND and the the XXXX. areas not return AQST-XXX, implications we outcome of of for ill-defined file the PPP to meeting as key that conditions. expect loan planned during company of epinephrine, Regardless changing to the quarter the for Because under these the the
AQST-XXX in is the that delivering an is systemic of for oral sublingual epinephrine anaphylaxis. film formulation, development treatment
requests seeking year. toward progress buccal for Libervant, diazepam later to continues of assigned the the XX, the goal September of this accepted XXXX, continue to business FDA engaging We The to Drug Prescription company for start work including Libervant. of clusters. responding with seizure interactions, Aquestive management our trials User film Libervant. FDA date of in NDA for expected the related course in Fee PK approval PDUFA, information has with to The normal is FDA the of Act,
to we to will, a As Libervant regulations to who product patient the also FDA congestion, be in of the treatment will within FDA for that as or delivered to effectively use to to if able device-based in we manage may first choices, to sprays the not options. Libervant compared have irritation, epilepsy and especially the due said, contribution currently expand U.S., represent patients, nasal clusters available seizure allergies. are orally seeking nasal patient care seasonal guidance demonstrate meaning available diazepam-based for marketing major patients approved
of of SYMPAZAN, LGS over and payers Libervant, market with oral for adoption quarter XX% growing This clobazam, its expanding associated in seizures same December market is the product over base syndrome the film to to March treatment for and caregivers. XXXX. the continuing relationships Lennox-Gastaut increasing Aquestive first with received prescriber Concurrently, or XXXX, an
the hold to quarter. lead the strong production for book associated APL-XXXXXX, Suboxone, strong quarter order apomorphine. share with market first The of the the XXXX to anticipated with product, in has team monetize second continues a seek begun and strong royalties to Aquestive's Aquestive licensee process
we our determine this only for monetization, including nondilutive appropriate of business, at well capital business The if expected the to along the resources that when time prelaunch our and preapproval approval associated and the PDUFA cash the capital from additional conditions receives fund transaction that would that company goal with terms XX, monetization and occur into company. May and The of are careful after XXXX, Libervant expects FDA date our any potentially Sunovion a other provide effective, the with XXXX across management and would with beyond. spend of an
discuss of Let's the these for each detail areas more in of focus key company.
the FDA we First, with promised. for file in the as expect quarter XXXX to of AQST-XXX IND the second
work to clinical as of to expect and before the continue year initiate trials We the PK end toward expected.
points confirmed the pre-IND As a had epinephrine. with meeting agency epinephrine. two February early for reminder, key a constructive regarding very in The we FDA
for First, Aquestive. be as under will reviewed XXX(b) the regulatory approval clinical epinephrine development pathway the (X) proposed by
medical that The be also that and that guidance gave resist they second, of significant address unmet studies need And clear patients additional confirmed a are looking may FDA in for AQST-XXX intramuscular some standard would of us is in among also use IND the of the anaphylaxis, understands about application. no of treatment The prior care there those and needs. that the potentially proposed what and opening our who injections subcutaneous unmet program. to FDA development necessary
development outcome continue of to costly, faster meeting from this path the based that, filing We FDA, and less the the originally complex, on a potentially anticipated. for epinephrine than less believe will be with
goal for assigned Second, a was accepted the in of January Libervant date filing and as we PDUFA XX, previously communicated, XXXX. September NDA
for we've FDA few the number continue filing, the information past at indication indication point related course normal received our see on that a the track and this to delay, of action we with of no weeks, in any to requests is PDUFA business Over agency. no have We as XX, and think September of XXXX, from engage reason to are not the scheduled. typical there correspondence
to by long-term we Pediatric clinical touched Day. Unit Epilepsy enrollment advancing the the advance development last activities safety EMU study closed to continuing in ongoing at on that Libervant the and in study. we're Monitoring We've pediatric Investor related Concurrently, or the December the R&D studies
We anticipate be from are the by final collecting top-line studies data XXXX. that studies the quarter these and the findings fourth We both analysis. the will of available from preparing
of anticipate impact these we any may review. the be in the currently We've on for these pediatric everyone under closed we also that that for the have safety include able remind Libervant. ages potentially to and study I of With enrollment to nearing Libervant patients NDA six between the expand studies our long-term two studies label neither completion, XX. adult
the reminder, NDA for analysis November filing a submitted included As the interim last data. this
administered demonstrate orally We're U.S., would the and patient We're the marketing further represent guidance would completing major regulations within as provide meaning indication. choice contribution the findings patient FDA approved under to product treatment seeking proposed the the available analysis compared available FDA that device-dependent review. of a expand to further will to data Libervant, to and options, the to the and as for its NDA in FDA for the to first the currently support currently if care
potential us shared, drug treatment, have treatment between when self-administration. it ease patient the and the in reduced following care. may for consider duration a that we doses to Convenient it of clinical comfort, burden, of location, major demonstrating periods for superiority As contribution drugs and evaluates treatment provided advances comfort FDA administration, criteria patient the longer
to or sprays products. care patient by demonstrate FDA are we orally rectal Currently be major nasal that examining for cold. also indication, of quoted one of relative allergies during nasal to this FDA approved delivered as these product be can the seasonal believe used contribution the We attributes Libervant, and/or why a to can considered currently to an common more has bouts how we and
pivotal with, any nonseasonal could or spray abnormality seizures seasonal study, patients A recently setting, that for severe interfere a polyps, its approved nasal nasal administration. allergies, clinical in nasal excluded passage nasal spray at with or
could Foundation types where also We have According last experienced allergies and XX to the America, to about leaders our year. from due million of not key spray the Americans are various occur Asthma Allergy nasal opinion dosing allergies. more seasonal instances in than of learning
Control to and changing to meaningful sizable nasal avoiding subject seasonal could as Centers of care American we the Libervant, that to children of not hypothesis a the average a have a major contribution Disease cold. we patient associated allergies with Therefore the plausible According by a two the show issues three is passage. This administered and Libervant common has patient's more. the and/or believe Prevention, that potentially per to colds is and know, even population. and portion year, you adult for orally, is conditions provides
million need as care, than accept. patients it, a one diazepam. when in need the where ability good need uncontrolled be treating its they successfully of XX% they and of is patients patients for for rescue with medicine these seizures they to Over rectal are medication. as only standard a A gel a it, used their of rescue, epilepsy application have by current U.S. and in the active Less form
strong very FDA superior a We have for with an that proposition, is believe Libervant filing accepted and approved can demonstrate alternatives. we currently we the the value to product a that clinically to
will drug and successfully our not may continue the we here. thoughtful choices, We exclusivity about to prudent overcome recognizing orphan be
we we accepting our the managing prior SYMPAZAN on And our therefore foundational spend the any do are to have to approval. FDA launching committed prelaunch on having that. Subject Libervant clarity capabilities greater Libervant and appropriately and to position, to commercial are
Next, focused building our we remain on CNS franchise.
of whose the Libervant. with commercialization potential substantially are SYMPAZAN, We prescribers of overlap prescribers advancing
the Our for profile in precursor to PharmFilm processes support launch the complementary prove commercial of preparation and technology opportunity. as and raise Libervant. out to SYMPAZAN the Libervant of of capabilities our is commercial continues build products aim a our of the in eventual
an commercialization value approved. if opportunity others, with groups our provide technology direct efforts and of basis SYMPAZAN that for the practitioners, of Libervant, PharmFilm healthcare about payors, would our the relating be All advocacy for caregivers, to patients, conversations
during expectations first XX% a we building XXXX, XX% profitability, proposition on penetration. internal value SYMPAZAN as of monthly over SYMPAZAN's Shipment year-over-year, block, third over The year providing those from quarter-over-quarter. our market patients of a further of March for volume as acceptance the an we in suffering for meaningful market. XXXX, of quarter to continue growth XXXX, basis in to reach the LGS exceeded grown expect important groups and by December SYMPAZAN on caregivers its XXX% focus and has performance is
those and since core highest-volume-month group The multiple also of for have penetration of XX% launch. SYMPAZAN writing in grow, to now XXXX, of prescribers end its base a represented XX% our of Libervant. accomplishing We prescribers last launched continues with over since work what intended for focus do revenue SYMPAZAN scripts. the the we product important the March prescribing for is stream over of build an be The continue we year. foundation was when to strategically to penetration XX%.SYMPAZAN successful the market launch will
surrounding initiatives energy our and all the and epinephrine advancing of on focus available to continue resources Libervant. We key
Additionally, we the pandemic. need of in the declining our Suboxone to adapt business recognize face and revenue from COVID-XX our react business to and
essential Portage operations to Warren, resident Indiana New by be are Our Jersey their deemed states. in and
our As Jersey. such, the at has headquarters its team in New R&D continued at this operations time,
access And produce these our for PharmFilm. geographies. number other access manufacturing clinics Suboxone face-to-face each of reported facilities all of with in We're live Indiana SYMPAZAN closely on mid-March therapeutics providers monitoring sales the The in continue COVID-XX our pandemic COVID-XX prescribers teams. and the challenges created to has notice. field-based their since Virtually target to of until our limited for further have healthcare cases
The SYMPAZAN with digital healthcare frequent their tools remotely and team basis. adopted engage staff a has and to rapidly providers on continues
we At checkup that point resume prescribers at seeing interactions. and discussion different reopening, Some states will visits areas patients that the different country. to the we have expect in is face-to-face begun it and of times expected begin resume some new of
continue manage and our will costs XXXX. our we such, target to in As spending
our are in Those guidance. plans reflected
We expect sufficient our on our cash resources plan are current based XXXX assumptions. and through that internal
with begun our buy product licensed investors the We subject by have that rights to communicate to FDA. apomorphine approval royalty potential would to Sunovion's
support capital the you We business release and we potentially XXXX. consider financial into look capital advance to time monetization Such to results the provide quarter be further us throughout any a enable our forward or as efficiently horizon monetization market capital and for to second additional beyond. and updating would conditions, our to company. additional potential will otherwise, expected We initiatives our with timing extend of provide of these structure COVID-related XXXX the of well to
With outlook. to floor performance provide who specifics and the of that, John, our will I'd turn to like financial over John?
