IMPL - Earnings call transcript Q2 2021 | Impel Pharmaceuticals Inc

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Operator

Ladies and gentlemen, welcome to the Impel NeuroPharma Second Quarter 2021 Earnings and Corporate Update Conference Call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question-and-answer session. [Operator Instructions] I would now like to hand the conference over to your speaker today, Impel's Chief Financial Officer, Mr. John Leaman. you. Thank ahead. go please, Sir,

John Leaman

our you, Operator you First We're that general will morning, Earnings as Financial well as and join us good providing review we can which NeuroPharma's update. Call, everyone. Quarter today XXXX Conference Results, delighted corporate during Thank Second for Quarterly Impel

Chief morning Impel Joining Adams, Chairman Officer. me this from of Executive Impel's Adrian is the Board and

morning, would have our I begin, like can this a conference presentation we everyone www.impelnp.com. we to at Before that viewed accompany slide to call at our which be remind website

telephone, that listening may results on remind you're ask turn I'd to advance the subject page that call, like If forward-looking this by actual cause it review and you to to call company would Click that, Adrian. everyone website risks results a the over deck link statements. statements to during I could on forward-looking the forward-looking With be your will Listen. slide are Slide in statements I says our and discussed will to from this the we Webcast that differ may you X, synchronized making on the that choosing access our to to the uncertainties Here If

Adrian Adams

rapidly-growing acute of an our activities a and with the and for the morning, for the time We core opportunity On find I the X, this Thank and morning. you, including John, opportunities morning's that and potential dynamic good brief overview little giving we're agenda lie begin treatments you're the our more in pre-launch, Slide value-generating ahead. will detail, will everyone. a of you market, of this launch certainly reviewing business potential Then, plans. appreciate this slide, call. overview migraine TRUDHESA commercial next and and

review a of another before our up over plans before Following of to will market results upcoming financial in to call turning second for I the back that, development will for opportunity opening and summary valued a INPXXX provide recent our conclude John more call your of detail. questions. with and the I the outline summary quarter assets, then milestones

time Slide believe points growing attractive new with the Turning migraine FDA this or an On acute year, I INPXXX, If review investment highlight using the we XX-month market date The vascular Impel States. opportunity. or aura INPXXX unique which reflects is just without three away. adults, and of to set dihydroergotamine X. mesylate accepted and Impel's would and or in TRUDHESA this for several space proprietary September of illustrate standard NeuroPharma. PDUFA to a which on has FDA nasal for rich a trade opportunity like POD drug now will delivered Earlier slide, directly large treatment weeks headaches with a market the in application United into upper the XXXX, is DHE the technology. review approved name X, target INPXXX frame

medical and in We targeted strategy, I indeed headache acute disease review area will advancing will aggression neurologists pipeline progress technology unmet existing illustrate you also our and unique need. we of INPXXX unlock see upper To asset, support POD Impel a next being therapeutic vascular with which leverage treatment significant we're nasal upper also lead the candidates highly shortly. INPXXX, planning more utilizes slide, Slide TRUDHESA this little and focus second for targeted that experience the autism, another our market which on use go-to In space. nasal in X, in a launch clinical a further for among fully targeting our detail the serious is early of are variety parallel, has with periods the viability knowledge, technology agitation POD the to Impel to rich are a the DHE space pathway, in with of October that believe We will a specialists. untapped evaluating. previously currently potential the conditions.

are intent either areas, through broader licensing development to other utility X. to activities. its strategic disease, is Although development corporate we slide, potential through in focused our evaluate CNS Please next and now internal, initially or added on therapeutic organic Slide our value refer

the a have both in-depth opinion past broader and all with the aim with of the providers key better patient tremendous discussions market quantitative year, Over we research, healthcare carried of qualitative including physicians STOP out part looking and reported leaders, critical community, outcomes in for Phase of Patient produced our acute treatment. study and and are this what patients X excellent understanding study pivotal XXX of migraine a results. were terms an design, ideal amount

were to study believe results that edition of launch We to acute the potential well-tolerated and reliable to deliver is August relief patients We these time FDA data these journal for the the Headache, Headache that that's are for Society. even treatment subject approval of differentiated, American published X This timing, with by the the just in the frame. symptom reinforced potential pleased our be October perfect TRUDHESA has planned official migraine. rapid a

showed its sustained pain patient fact, freedom data improved In reported to rates standard care. relief and and of [ph] existing compared pain priority

is growth the TRUDHESA. that in launch our better-tolerated as the XX like continued are there an in the would the in also lot end a therapies for search this being large the away from [ph] to and non-tritan to I'd to communities. were written still Turning prescriptions despite go-to therapy. in the worth on shift illustrate is migraine market, therapies, million for is much of neurologist slide, of this triptans, growth specialist Slide noting and to patients strong turnover strong At there This physicians seen acute that It this by of as by impressive and now strategy being headache now This continue to that into next part robust note year-over-year. more and X. market. X. XXXX XXXX, and like Slide of opportunity summarize driven growth I important XX% growth has our effective plan it's growth market and shown is

adapt with will commercialization experienced X,XXX for market initial we and highly disciplined will X,XXX high of are physicians. and professionals, pursue a size neurologists prescribing a of approximately physicians a around XX% of sales that These prescriptions. approach base physicians X,XXX primary XX responsible concentrated care X,XXX prescriber salesforce comprise We will

in and written target our are as influence of target acute strong amongst for community. on are but gold their efficacy Importantly, important, acute neurologists to neurologists migraine not experience current support DHE, neurologist all a product just that XX% product for These accounted treatment. of the growth, of XX% nearly prescriptions the for their standard is historical recognized migraine of because being also that because

do XX% plan marketplace. further we progress the our opportunity to of invest size launch phase, initial As reach by this during our salesforce of the our to doubling nearly we into and make increasing

Slide professionals. the will strategy our and as and next We organizations. slide, X our our our utilizes five top through This includes accelerated on affairs experienced introduction that and of and work also TRUDHESA You recognize promoting Impel swift the [ph] efforts pre-launch we of access part access we've medical our see share has adaption ongoing market payer efforts to commercial targeted in approximately goal early market covered pair middle large this market. in and progressing set of the pre-launch commercial our lives and of our of developing In are and XX% strong a the well in rapidly of by discipline triptan space to approach with importance confidence summary, failure post and XXXX. growing building been

underscore like slide, to our XX, next we with to see we that would technology Slide As platform. the POD I clinical possibilities move broad our

believe patients FDA formulation imminent comprised potential has therapeutics, of which treatment INPXXX used the that additional significantly line at with that relate and a the to its to in to majority in of humane POD and as to the market need, decision setting. to major reduce significant large is be room episodes commonly year, is cusp which intramuscular disorder. believe is we cannot this more deliver which is population. opportunity the limited patients being uncovered controlled autism XXX,XXX patient there the On agitation emergency powder agitation approach in a visits injection. home spectrum with olanzapine, We've TRUDHESA, visits next is for of emergency potential least a numerous a are INPXXX. a of INPXXX the autism use the has acute unmet currently for to aggression, as most the but a the We technology Therefore, deescalating aggression there room that bring

study aggression to according sedation, provides the in that administer, to Slide initiate The as olanzapine aggression As we approximately provide without consensus community ideal a rapid goal non-dramatically fourth on healthy is recurrence upper nasal studies to the our quarter next adults turn the for INPXXX in Psychiatry rapid our low year. sufficient in medication convenient are setting. we over is the that, of Xs for plasma the and which quarter. alternative results desired These reached a tablets. targeting INPXXX administered, results This or duration of agitation tranquilization levels for action prevent concept XX adverse easy John review peak orally-disintegrating year. Phase as home, than the was risk in acute to are intramuscular marketed published may Phase INPXXX in as agitation X space and timely With treating interactions. demonstrated Clinical we've fast as drug of to last hospital swift achieve future and I'll and non-invasive An excessive of acute call Journal the events absorption of ZYPREXA with now an financial by this autism IV-like onset XX, effective, times that for faster and were a and proof John? as conducted, and in on findings currently to the twice planning illustrate INPXXX expert slide, XXXX

John Leaman

The primarily in Development results On TRUDHESA was Adrian. the administrative of you, compares compares with a $X.X were Please spending of launch. preparations will Slide for quarter second expenses our refer $X.X XX, Slide of the The for in due XXXX million, XX. the due Thank which to $X.X in second commercial XXXX. XXXX. to see R&D for and in quarter XXXX for $X.X quarter now the of the decrease quarter G&A clinical X you ramp and primarily second post Phase with cost to the and was the financial completion expenses million quarter million, decrease which activity were trial. the slide, Research of expenses marketing second XXXX. up second this for of the for General the increase TRUDHESA million for next

for $X.XX a of the $XX.X The of second in second of loss XXXX, the $XX.XX loss net for a per to second share of net quarter was XXXX. quarter [ph] million compared the Impel reported period million, of the loss For for $XX.X same quarter and XXXX net XXXX.

announced As the coupled of This Adrian, cash XX, million. back balance cash of like debt had we I questions. X, July the a who Adrian? the cash XXXX, hand with XXXX. end to provide will now summarize the company company and the call for through of runway financing the on before with June equivalents would to $XX.X cash call opening

Adrian Adams

like Thank would conclude upcoming This I potentially you, transformative an exciting On John. achieved milestones. and recently highlighting Impel. our for is final time by our Slide and XX, slide, to

with proof in tremendous acute X FDA instructions? open can for to TRUDHESA rapidly migraine to We the valued We of into to concept Operator, questions. and your you growing XXXX subject give market call like approval far so forward, and launching please the up have a study the would made now successfully to progress Phase INPXXX. initiating look

Operator

of Our Covenant from question [Operator comes Instructions] Ken Company. first [ph] the line you. Thank of

Your line is open.

Unidentified Analyst

for call. guys. morning, the Thanks good Hey,

what there? Just pricing little Then question, any Ubrelvy. for solid it's for fantastic a both really, if if can prescription. been can Nurtec to Adrian, net FDA a couple you with questions. Really managed launch give That's the first second care in value you good we're success appears and color labeling question. provide in nuance very my a of on be wondering interactions bit or

you'll could or nice example talk a lastly, massive prescriptions. a in like just was could do be both setting care you you if about then think as still pricing, views on churn failure a nice with that CGRP and of And about managed how rates So, between and in you comment terms if of wondering able triptans feel opportunity, to we looks of platform a wondering lot TRUDHESA?

so, failure hoping you Thanks was could rates? And so much. I frame the

Adrian Adams

clearly, was are I'm I how Thank would think, FDA things Ken, the with since many right. Thank tracking as say All file question [ph], to responded you. had time. is to information of looking relation our that's clearly. comment business to we a weeks' a PDUFA you, And that review for of normal we've minds on accepted questions in of sure the all and number We've question. and course three FDA. the I with and promptly specifics on it's date I the are January for the FDA. in with requests can't in those forward

the early for commercial the during I to time our preparations addition, call, In frame. make did October reference

the discipline August, started our We've of and we our have XX-person sales, head of We outs hired during recruiting regional commercial are hired build we've salesforce. of organization. the managers, course

timely the the that right you questions as we've know know, So, don't in prompt set responded and FDA, all but up until you we've well would with had, the way. end, I a

success proportion with that quite actually that a triptan with you've by seen the of and very Nurtec growth. the in therapies. point that second presentation from you're think they've market right. our success manifest the as On of the We've had that think non being I in is Ubrelvy, clearly pleased I terms driven is been we're And marketplace, and delighted high clearly, on growth

have turnover pick questions, your a last things in to is the one tremendous think is we I of there marketplace that therapists. one your up of within to Just point the that on noticed

the that's a these and top illustrates driven product is clearly, are John estimates in is we've switch who by feel from on Our therapy. there treatments efficacy either work tolerability. enhanced I'll being TRUDHESA for that to excess market are that that to manifest moment. XX% of that enhanced for are XXX. from that all desire we or given tend of that our turnover the is patients drop-off potential in a done these What comment profile And ask away the put in of in of clear the

clearly, asked that but the to XX% market doing been by next space. launch just of players have and achieved is was ahead lines access think questions of roughly environment. do amount a newer about want by market not in goal I of price our information in exchange launch, do to by you at that time relation product what a We've with you middle tremendous successful also launch. you dictated And commercial the year, in care managed of We a the view what is some [indiscernible] being the access of is the top covered of which in frame. what

the with we've from We are payers looking proposition forward you compelling actually a a bit to amongst products rebate crystallize maybe pricing discount But exceeding with us the strategy. that. had allowing that the interactions strategy that overall perspective pricing had are a the on And will value comment and to our that ask flexibility I'll give to offer all clearly, to-date we just to strategy John, indeed further. a

John Leaman

basically a and of be And the on to I being one at pricing. Sure. access upper different through on, that. [ph] a making the I I done and in towards for pricing looked we've that range look the brought and great several the of at the at times, pricing, would that TRUDHESA, four as of range he's payers think, she's as is believe we Adrian, probably I add we are as focus just range That major that think of progress getting end this we've pricing. stated, XXX team previously And at different a our as what somewhere that think look we'll for [ph] between the looked prescriptions we we've four-pack I XXX taken think pack

Unidentified Analyst

time. Great, thanks much. exciting so Real

the queue. back in go I'll So,

John Leaman

Thank you Ken, for questions. much, your very

Operator

the comes Eddie Guggenheim your question next line Securities. And of of Hickman from

Your is open. line

Eddie Hickman

my Hey, guys, thanks for taking questions.

Thanks. then will So, if you strategy, launch? earnings, talk approval consider targeted the most given can think to do And what CGRP dent you the in the about launch on get early you can kind the you of RX next important you of your you month, metrics and start future factors how numbers? launch a in what quickly make disclose sort

Adrian Adams

much think very are your just questions, emphasize, think targeted, you a to the Yes. to for Eddie, very we disciplined I adapting I approach thank markets. clearly

reiterate, evolution those and believe evolution do and headache that and predominantly prescription specialists. is neurologists, eight given market targeting we we up target clearly, of target targeted the belief this the repeat [ph] only kind that of approach positions powers Just of because to that measure made in in one key I success, our audience. point, share have

So, strong are be or indeed of evolution group. line, TRx already in acute important. top the believe is very, is migraine, experienced and passionately of by target market support NRx that the DHE utility of to measuring treatment following growth, the We in very we're metrics impact that the perspective, that prescription the that account uptake addition an them and going given share of the in and very supportive neurologist the community by very, to

clearly very very strong are we team metrics. to QX, that the with in make a obviously, prescription as the year, market efforts those is to we of next with want are have top reasons over of start one QX we going into the access population. loss, That QX, clearly, payer to be evolve And sure investing So important in pre-launch all journey. we

very treatment well next and into launch of will sure a lot competitive to in during we the putting over clearly, patients way And want part quarter of measuring early ensure quickly one is fourth of year. market touched first this that place our it's programs to we obviously, of and get the very number of you've a think be have questions a that number as make and uptake the So, that we phase access that's year, how I in a quarters. success the strong of can on of initial to

a So, our you while building up the get in market ensure market of the number treatment. to putting to points? access John, patients But, we want to will quick we're access programs, to which that do anything can that are patients footprint rapid in area, place start add our those

John Leaman

space I we're going don't, to X,XXX drive specialists the out think I that, as would our monitoring Adrian That's earlier, launched X,XXX just is to market. I is we neurologists product. scripts. success And we're where I think doing there's in to and the reinforce that Adrian, really looking as laid be key target how headache

Adrian Adams

just point. for really important particular. we thank And, that and target final monitor The specialists one headache you Eddie, in questions. believe Again, neurologists it's this your success reason group to and in

of at about made essence prescribing but I product community. I that strong been Ubrelvy, success, that this That that forward. written despite physicians to market. very have the been to-date, think on of if neurologist also you of there's is of we turnover of with X,XXX grow lot how X,XXX amongst analyze success been in we've and and with in the I the Nurtec predominance come prescriptions launch, XX% the Nurtec a looked -- Ubrelvy reference our to from that have for since is It strategy a all worth actually the excess both earlier around of prescriptions pleased if to and XX% noting intend is targeting that moving

Eddie Hickman

opportunities? of metrics there? trials a little more Can the sort look program looking of bit about concept? little about talk at what autism in what like, what indication, proof thank pipeline could also you you'll you if kinds need show for just the bit what Like about Then you're Great, a that much you you're of and thinking so that.

Adrian Adams

on top that. I'll ask comment the line John? John of to just

John Leaman

concept at I initial Eddie, Yes. looking we're X of proof Phase trial. think

be on stimulus. in we patients doing As would in that year. of this have quarter the we've who aggression They ASD. have fourth plan indicated, typically That a

improvement a and the that product. to bipolar, at in use our right we look the placebo basically so, our basically aggression test without we in can And with environment, or happens schizophrenia basically versus product a scales take can

be with think I fourth quarter the proof into basically And we'll plan X having then those step. results basically, will a forward. going that. be But move the that post on of of Phase We to concept. the the XXXX in start first program would plan with results

I has utilize caregivers a anti-psychotics. I Adrian much shot, pointed that atypical worked the more through and like and it population. always -- in think I've We're in but out, As really this a not And would actually to convenient parents nose. giving the say ASD. would ability

we'll So, results initiate of next said, we'll is we step in half as XXXX. fourth and trial this year, quarter the second the have

Eddie Hickman

Thanks, guys. Appreciate it.

Adrian Adams

Thank you.

Operator

from line Wedbush Laura Chico next of question comes of Your Securities. the

open. is line Your

Laura Chico

guys. for taking Thanks Good the Hi. question. morning,

have I device the quantity questions drug maybe think some inherently process. advantage review known combination. on you of a relatively But DHE here. are already been guess tougher my a but answered, I of These one being have

So, device concerns I points NDA if wondering of what offer any guess from have I'm around in the you maybe you. primary commentary review, the can just submission? been terms Thank of the regulators towards

Adrian Adams

Thank is the through clearly, used that very been been way in question. important FDA. product the doing the a have device. all consultation that we've that of And And one discussion we've you, the this or with TRUDHESA, and in with same times. development same the think again, the asked I Laura. area we competence number quite that We've a reasons That's of a

an manufacturer. with looks drug In at manufacturing They're that XX-XX drug the DHE, for meat lamb addition, [ph]. and one from a the if component, have They're I FDA. years are well think, inspection over we sourcing history FDA-approved good

course as as to of perspective, normal those of promptly. significantly consistency last something combinations. think, from clearly in business. and of relation both other FDA all the of questions being answering and answered all which consider I and would has drug lowers drug guess questions I And we've a clinical far I device been those number components, from particular And that think so device course interactions So, the CMC the of of we've months, a our other all risk seen I that I points development with saw it, over through believe professionalism, been out that the we

how would to respond that's that, So, Laura. I

Laura Chico

very much. Thanks

Operator

in the to for queue Adams questions And I'm no back you. showing Thank Adrian time. at this I'll call Mr. the hand further remarks.

Adrian Adams

would very so you our on much And much, progress going for Ludy thank time this corporate continued forward. forward morning and this to we thank us you to morning. Okay, for like milestones and all your you you look I updating joining Thank [ph].

Operator

Ladies and today's concludes gentlemen, this you participating. Thank conference. for

You may disconnect. now Have day. a good

Impel Pharmaceuticals (IMPL) 17 Aug 212021 Q2 Earnings call transcript