management member our team. developments our Aquestive a joined our has will and become a this this on quarterly and the Officer I business to Thank X you, would morning. today, business already December you Interim valued company’s fourth us like of update Ernie the and first his to him In welcome of XXXX. joining call first and of Toth, to introduce thank months Stephanie over you Financial everyone for I Chief important in quarter the Ernie and for discussing remarks Ernie take opportunity the call. be in Aquestive number to
team always, I Q&A and Aquestive Ernie the of afterwards. session joined members be leadership during As will additional by the
successfully safety the time As interact same year, patients priorities products, past that of with the and while the company. colleagues, the we continuing caregivers this proud important do our at who business events as people we the look work to the key advance are able were our of we with the and a with, occurring at starting back we extraordinary to company on during execute our
Let’s look performance and at made. for we our progress XXXX have the
for drivers milestones related a company. delivered the to through committed value of we number As we our important key this period, of
Libervant simulations resubmission XXXX. of modeling the supporting in after our analysis the receiving and its process application First, from for to FDA and the of guidance is company building new The in PK franchise. we the CNS relating included the information in December on prior finalizing expectations our remained drug on focused agency to for our submission
alternative difficult rectal an gel, as to device-driven the Libervant including developing for refractory inconvenient a alternatives, and to administer invasive, currently with patients are We epilepsy. available
patients U.S. to in a by if consistent market a result appropriate innovative a issues treatment treatment form. receive believes the treatment patients population of share many and Libervant, have access, approved the in As regarding altogether. the will for market, patient does portion non-invasive providing for of not therapeutic receive those that company current enable a large The of adequate dosing products the larger or more these treatment
to As address we to in in the FDA weight-based modeling we response letter in the by issues received and complete with along regimen, communicated, the dosing data resubmitted December raised September. XXXX revised previously the a agency simulation
single-dose CRL that As provided patients you population its the the simulations that question its FDA studies in to crossover as provided The the in study be the of and X data information response and feedback in comments which February, PK the Study the the in in FDA in maybe relating should we NDA. in In submission, modeling safety model X in recall, be included our out CRL identified to the addressed based confirmed package by we expectations written may NDA submitted resubmission. October. the utilizing issues XXXXXX. FDA study in FDA to that clarified XX limited presented upon PK our the to meeting December our the information in The refer to was included that
end quarter clinical studies for Libervant. continue we of We expect feedback, on the of resubmission that Based NDA and we the perform review process. resubmitted, a file FDA’s the believe no to anticipate additional further second to by will analyses for be necessary the Once X-month XXXX. NDA the the the
regarding PDUFA the we guidance market no FDA to date been market relating from to in to-date action prior expect PDUFA receive We of access continue do date expect to There access XXXX. Libervant. to any the the indications FDA have and not action
duration that drugs access, we a set that indication for prior for clinical this facts by approval strong based care. provided patient FDA that Libervant reduced approval. including with delivered treatment Libervant launching comfort the more and possible the administration product are Libervant we demonstrate meets advances have of care, represents reengage to have NDA Subject position soon believe FDA an and communications as will upon ease finding of major after to longer for to that our a patient contribution of resubmitted of burden, doses. and superiority. a FDA to of to Once contribution criteria between drug the as treatment approved the to update treatment, FDA supporting approval, committed we orally in decision one be a comfort, patient Libervant, we we of U.S. major considered a The periods as convenience Regarding market location, prior or
its epinephrine delivering Aquestive’s first that now PharmFilm anaphylaxis. the is treatment of development film to Utilizing formulation, exciting AQST-XXX, Let’s turn oral systemic epinephrine of program. technologies, the kind sublingual our is in for
is process conditions development injections. have review measurable PK deliver X unique Investor we that leaders unmet these trials program presentations patients demonstrate resistant X event reported, sublingually. fast The XXXX. August clinical opinion of pathway. that FDA deliver or senior facilitate that key track studies agency share under and a.m. two treat the therapies previously XX track for can FDA To-date, top serious designation, an concentrations all and AQST plasma and scheduled approval about further and track of in AQST-XXX in to plan the data epinephrine. a is taking the of designation XXX Phase granted of epinephrine to an line The We for needs. can management during this for In Fast by to PK intramuscular provides data expedite Analyst X:XX with completed As fast to evidence Phase is consistently that the satisfies reviewed AQST-XXX Virtual at we technological subcutaneous those two the the details the field Aquestive acknowledged product. the epinephrine AQST-XXX developed from Eastern in need patient granting have allergy the a for unmet solution the for trials team subjects relating have Time, development the March disorders. sublingually medical designed epinephrine to delivered fill Aquestive prominent and being population XXX(b)(X) and that strategy
Canada the provide in months This management dosing Additionally, With later. Health we to KYNMOBI, options PK activities, and submitted cash to-date Phase regimen. hand, us more OFF episodes plan of on importantly, for which XX additional speaking final of our capital, step capital, of to third monetization for cash the we this launched soon from a and detail necessary respect monetization, for have when study rights by toward Sunovion for our more be Ernie significant completed KYNMOBI this as XXXX is disease. we as needed. on our dossier expense net November, is in about another September will royalty patients used capital treatment by Most activity a with ATM the Parkinson’s the trial formulation X the or product also Pharmaceuticals, product commencing receive with in in suffering provided more and a our documentation.
and Next perform healthcare SYMPAZAN. with COVID-XX interactions providers. grow related to face-to-face is on SYMPAZAN despite restrictions continued
saw in XX% the grow pharmacies were that quarters focus second the to absolute, of XX% have this SYMPAZAN for XXXX. times prescribers the While shipped been with revenue continue and they those to even in company’s to able net scripts. extraordinary in believe writing and group at with growth XXXX, SYMPAZAN fourth growth prescribers, grew nearly prescribers prescriber continued and our multiple prescriptions continued we of XXX% over virtually through these as that penetration product scripts restrictions versus XXXX into base, times. We were of connect much and of over demonstrate
pharmacy We Medicaid with payer currently acceptance to all important and lives a SYMPAZAN state Medicaid for over claims XX% believe in position be up an coverage continue of our commercial covered launch state and prescribers Paid We of XX% ramp Libervant. successful of commercial regions. and claims. payers to XX% and were have will
community. and patient commercialize serve U.S. license, million EXSERVAN, that is with expect currently innovator payments as we mid-XXXX. supplier treatment Mitsubishi product. an sole January prior of entered Pharma had as and $X we riluzole the Mitsubishi received additional and to for the formulation Mitsubishi a Tanabe Under with film January the exclusive commercialize ALS EXSERVAN, for in milestone a will to supply commitment America we for anticipated in XXXX $X the and and in previously, oral launch, in an ALS. licensing EXSERVAN for committed leading U.S. a we to will deep million the Regarding of XXXX rights the in manufacturer agreement
are we the Mitsubishi, the to royalty to supply net entitled from addition In revenue with sales the generated product. the of on receive exclusive double-digit agreement payments
Next, additional to as strategy experience members with the add we and our executives is commercializing continue company evolves. to company to that the proprietary products, execute Board critical and expertise additive continue potentially developing and as of and we
is Officer Chief and and As over Health. recently Dr. executive Dr. with was of January Marco leadership Mark Directors earlier appointed Julie additive the Independent Medical of years of and Officer Krop, the the over has introduced, our are is senior as Medical Officer a Toth and ArisGlobal, pharmaceutical experience in for appointed allergy Julie biotechnology and decades Marco Mark Dr. current December with February XXXX. brings and was in Executive development EHE seasoned Taglietti, Lepore Board Financial to Pharmaceuticals at Lupin roles Board drug Board-certified pediatrician allergist and of significant SCYNEXIS, President financial and that Freeline XXXX. Teva financial of Ernie industry as Directors. most experience at a in Chief JHP appointed XX Officer Chief Director, in of interim were Pharmaceuticals. X Therapeutics; Pharmaceuticals Chief prior to and with
products We’re value valuable perspectives they company’s provide and patient needs confident enhance fill develop for commercialize shareholders. that we will to the and continue that as proprietary significant unmet
We contributions Regional Chairman Board retired more many valuable XX from to of Bratton the service in Board Doug Board. as the Doug sadly, our his years. for thank company of addition, our years after February and the for In his than
products. proprietary to forward advancing summarize, So in we’re our going XXXX, focused on
We’re an anticipate after Libervant XXXX quarter NDA our Libervant, preparing possible to for as and access. second soon file resubmission end for market the approval the for expect the of launching FDA of of as at
our grow establishing Phase soon Health epinephrine epilepsy our X of as the Next, we’ve submitted plan to program third SYMPAZAN anticipated receive on dossier in necessary continue a while opportunities I of these part and efficiently to advance of an We strategic in trial to to us finally, revenue for and as as that, this We’ll Ernie, commencing to you And to With expenses outlook. our as the we turn shipments Canada advance relationships capital documentation. would study PK continue market the look all our to who and as always, consider we for performance horizon. and throughout launch. extend forward, over update financial prudently manage continuing we’ll Libervant will of XXXX. initiatives provide specifics like cash floor
