KMPH - Earnings call transcript Q4 2020 | Zevra Therapeutics, Inc.

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Operator

Ladies and gentlemen, thank you for standing by and welcome to the KemPharm 4th Quarter and Year End 2020 Results Conference Call. At this time all participants are in a listen-only mode. Please be advised that today's conference call is being recorded. [Operator Instructions] I would now like to hand the conference over to your speaker today, Mr. Jason Rando from Tiberend Strategic Advisors. you. Thank Sir. ahead, go Please

Jason Rando

afternoon, and to financial our today for corporate thank KemPharm's fourth you discuss XXXX joining quarter results. call Good and and full-year

remarks to Before to, statements forward-looking statements not regarding at risks are expectations our would any begin, and involve this future like about uncertainties, to we listeners may KemPharm's I that the operating limited subject made and contain time, during call but remind results. changes including,

provisions with KemPharm as and are made available of represent or are the Forward-looking forward-looking by obligation pursuant laws Actual required the Safe complete Harbor to More forward-looking federal on statements, to KemPharm's and except website the uncertainties information Relations statements found risks be under management's results the section. regarding filings securities SEC, may disclaims update statements, expectations. current its differ can Investor which revise materially. any law. KemPharm's in

call be and on Speaking KemPharm's LaDuane Clifton, President and CEO, will CFO. today's Travis Mickle,

remarks, submitted that, there respond to have of regarding With be that approval session my answer is week questions to management and been which the question KemPharm introduce the that during Travis. company's will past AZSTARYS. since call Following pleasure it during a will

Travis Mickle

the everyone over Thanks past provide wanted just few some afternoon, Jason, to and for discussed this months. thanks quickly what recaps updates, this joining evening. we've I really just

the most actually the I will questions organization think and to we're we around of now able out. report focus Here, the most our position since of be received that financial of that

position the around focus very I will so call organization. the the center think So, of financial of today's much

sales the KPXXX/AZSTARYS. agreement to release a Updates more press hear want hopefully AZSTARYS. from release milestones on mid-XXs. on license but an than approval also call APADAZ with revenue. is based Please, press based that on product. the receive of into agreement And you Greatly has again other into financial you This growth of there be the regarding with that entered KVK about case the to $XXX amounts Point are Tech up more on for we're this approval milestone private totally of aware the broken approval if person affiliate: of provides really read a is eligible let Tier FDA Corium I other will Under to through course talk regulatory the a AZSTARYS start is Gurnet single These million and partner Capital. sort course are That to position, us AZSTARYS. in Corium every consulting to LaDuane issued the we've included encourage we little up an commercial week. the with collaboration ongoing partnered milestones. a of all in out, And to out in them core sales product will in listening projects seek improved program includes of I their to Corium. our last of course and additional So, just the it this. launched various also of have Alabama. up years our partnership that's launch

as end towards And call we two on everybody looking have go future think will helpful context assess value more I as the listening achievement. and product, future product see provide for tremendous then, time that the a the the value through of well great I'll before ago, of the little value the him to this for a want that. think little everybody from turnaround very that forward be bit let mostly of believe kind to I to can the do this we I ago point the year kind outlining And of years as organization. detail. product spend even is in proposition a differentiated, the the where help to some proposition bit of you

about into with I of the approval So a bit jump AZSTARYS. little that, will right talk

the new Of actually This event. late-night was a on so course, was There knows. just was third-party second. very approved this everybody no

In fact, the expect available Corium had home from us many that the half. for really already day in for second make event it's letter the that's in the FDA. AZSTARYS U.S., gone to happen the of does waiting official to

great launch beginning an I very to think at general year. for It the anybody in at so. do time ADHD would the that product of was school

would each far not only one active KPXXX. Sternberg's these our we in potential only that a LAT and of be shoes at where the the ingredient spend prodrug validates over same if goes get approved. also of But attention. there AZSTARYS, focus is was AZSTARYS goes developed Perry here beyond lot approach do will most we've prodrug's approach effort at This to the the that So, I Corium into my KemPharm. KPXXX. in I time approval value NDA It's active, that products on this the

in it's history. pivotal our So, point this a with really organizations

the little partnership more. a to bit Turning

this we in The commercially. there really very at a complimentary already partner was mentioned. that excited to much him mentioned commercialization is that now such it commercial of Corium this I've made of those guy And is Corium. XXXX. this it who have assigned been him to company in license, Sternberg. to is the have really of team great team portfolio For that a the already have milestones royalties, by great finance with It's aren’t here off rights GPC, back September And I are directly KemPharm. headed who with at the Perry very really development again started a what familiar with we Corium. worked

this discussion did I'll to big briefly I a touch on just This So, is the prelude a some very want in related the growing marketplace and to some have of to is question. market. really

number up really but all two billion At that particular And underestimate of we divided the understood. market out not really far ADHD; stimulant, product of our it's non-stimulant demonstrate this methylphenidate-based of improve a advantages think these can we products how $XX.X categories, in we products. go products. I if well case think stimulant-based about two different intended in major believe with and only sure when we so to key as as has types many that he yes met

So over with that, actually over, I'm going turn -- he'll to it it financial and turn update. through to LaDuane back the sorry, go

LaDuane Clifton

afternoon. Travis, Thank you and good

a year Market string on the company's quarter pleased quarter. consulting Corium and debt of as already propel arrangement culminated runway spoken that series And regain company of that. $X.X has and is And We that new of capital which of significantly now, of balance with arrangements Capital about share the the since revenue than compared company's debt that $X.X at reported added in to of really be February compare a and it been the to frankly it's NASDAQ we've years back substantial we or the million growth been composed has efforts. a and net about proceeds position even the we've to We see completed. year $X.XX the than QX loss per but given to a sheet the and you about were a probably transactions and our more of really great major us in because pre-IPO. of under in that Xth. basic reported been of As the our just extended share company we've really talking time, $X.XX financial eliminated for strategic XXXX of revenue was $X growth approximately but further the the transactions to with went accomplishment least allowed financial of excited whole pull all I'll about XXXX. QX; can of primarily the listing back of us new restructuring we culmination rest began a million, other multi-phase to QX January. services certainly to This a set $XX the for results, really We brand different that astonishing. basic KemPharm. million report per that's for to We QX This that $X.X result under was are consulting that for available net back options the for future. loss a million pretty Specific couple the together prior or diluted went last able process million same

posture primarily operating decrease in was operating same driven of in Our to was XXXX improvement an by about QX as expenses as is our for loss QX $X.X the you we during and well as an $X.X can at -- increase here comparison revenue million QX a the $X.X This you million, quarter 'XX. in by that since are the million cost expenses our same have structure maintaining adjustments XXXX. expense Essentially can in to $X.X since see million. been And that XXXX. our see here, XXXX G&A we expenses at R&D

related now increases full-year Turning our results, to of revenue expense operating $XX.X we primarily by XXXX along million of share in had was the for with was I've and $XX.X as for operating was of the in at an This the follows prior to well regulatory year described diluted was loss $XX.X $XX.X million XXXX. May KPXXX that to milestone revenue revenue we was million. of the Compare so to revenue $X services per primarily NDA. the full-year million what received $XX.XX XXXX NDA XXXX, as million financial about $X.X full-year or operating QX the to compared $XX.X to that and million. compared for basic deluded This acceptance $X.XX that's loss loss and of in full-year share a and million improvement of driven $XX.X and for or already loss last AZSTARYS Net net per expenses. XXXX now The decreases about revenue basic million in XXXX. picture which

as story not know. sheet. And we've to a as months course, balance at cash through of balance of as of well Now, year, had you we few million that's of is certainly turn first the fact $X.X this the the but XX/XX gone

beginning decrease have on about the with live several really QX rate quarter. XXXX. of the in now, and been resources we burn of over existing that last around Our Based $X telling a going all and burn place rate, that's the had and million case during transactions of that quarters $X.X past taken consistent the you million remains and per of

is great you sure we remaining today Our we to not are $XX.X related milestone of current based Fewer rate but net any our place net make as warrant the it's really well We the three accomplishment of in is normally total as million did million series kind a Total fee of and paid at as million We much that different we but over of coming operating converted offering. been sit came also as cash XXst longer than million today. that’s 'XX for company sort put in yesterday longer. amount is the really the million. this January be in Tiers that number where at outstanding principle we at January. March we through place. of last AZSTARYS. XXth, Again, $X payments was the exactly fully of Total several $XX We debt forecast. cash least $XX.X the include been stock shares from And even of of to extinguished. just And honest February a December Total This know a as approval of cash wanted as weeks. taking interest does of pre-payment the of ways as is got in then, a you at that paid cash also $XX.X had have preferred run here. exercises out that are to on that that's XX,XXX,XXX. transactions XXXX. XXXX, through yesterday debt This its a

later. outstanding shares million been has as million try address upon ones. XX.X X.X can go more how the The have and through that diluted remaining that the exercised press and of exercise includes detail shares we Before exactly we questions to we release many issuable of around

today of the none of conversion was feature is that is as in cash all March XXth. that issued in balance of outstanding the that preferred that Another structure preferred stock of debt,

back to So with I'll turn it that, you. Travis,

Travis Mickle

to we Alright, with this address coming do we from thanks in taking if we so want format not our color We're questions those a and possible. XXXs And of shareholders. had of XXXXs unique also of bit are -- as analysts. LaDuane. questions from many time many a just addressing little as We

to business did a something talk had, and those it's So, answer to want maybe or or either is. form something it's It's don’t want that we presentation that else because in something that in explain. because the discussion. we we form kind you very it we've other was able address can't a didn’t We about a it information It's that collected ahead it's have the in we those can answered have you of all plan just in we some question questions I time, tell of if mention to we consolidate everything precisely on to a confidential can. valid reason. whatever that

have We everything responsible legally you to to is tell do.

So, please it we've everybody we what know. as represented well that are of to feel that everything but know should just is as you think are questions important many these a piece of I heard for things

Unidentified Analyst

clarify after number you goes one. first outstanding what for the Really deluded Can the restructuring? you've So spoken LaDuane. fully of shares already off the about

LaDuane Clifton

Yes.

moment So, that's then stock shares. inclusive that X.X that the number ago I really included to includes a a XX.X that number. fully that And more that, Again, issued. of million. preferred every in transactions were again that just is was deluded of recent spoke element It it's million

Unidentified Analyst

similar. you the Okay. exercise can clarify market as Well, It's different bit one's cash as is the position. not current a little well really warrant This of exercise. the and the cap one next very number

LaDuane Clifton

Right.

release the tried detail too. provide press we in So, this to

cases to and exercised that that as regard shares warrants XX.X into reason or number basis. been primarily a So, in common warrants the of with were have XX,XXX,XXX exercise, list for warrants a some cash of is of on The to-date million stock. difference yesterday, converted exercised

is excuse in that to issued So, being exercise remain it that a cash balance I cash large of included but result that already the company actually incremental in million the of the less majority the into or shares X.X in which be talked course million. the warranty was mentioned And we came -- company exercise $XX then, me, is about.

again And where market base we And $XX.X million you Our right we've in already guess that. GAAP, current talked were calls about and if today's XXX. on cash position I then, do now current it map the a GAAP. you XXX approximately would assume approximately. times million the at outstanding XX.X market your basis, is the On fully that XXX -- million is GAAP shares On basis, I guess diluted XXX.X. fully market diluted suggest just XX.X

we of that flurry transactions basic intending because pretty pretty question these of And of a I does filings seem do it obviously not transactions. while but all have So, well. to do that answer very know questions, been these the lot that it's we're these required like the to obfuscate technical

glad where could So, or in to there at clarity and continue through at questions, continue if are follow-up some clarity today. will way, Tiberend send I'm we try info&kempharm.com any either contacts bring those the that provide And we to to can. we by the

Unidentified Analyst

The general LaDuane. Thanks, more one a next of is question.

updates of of I folks understand A think course Corium lot and of that any has provided. a I it. are plans they that commercialization the to covered part trying have

to one I covered of that that. related I've kind launch believe The is to to expected. first and

as release I issued, Of -- well press and as states such. the press as belief that that we course they release there all think we in reviewed my

contrary. So, nothing there to is the

read website. I past think the of It's our the located for best done. KemPharm far slides, the to transcript as event as sources actually go found going full That's that that it, together. any are the very you Corium in get presentation section it's is there, and detail, find in well a see

our label. than talk we from excellent think is important an you shareholders that the to the When some I do where means label ADHD best-in-class And just stood, of we to believe fact perhaps your done resource. scheduling you its about best. the status/process We've questions changed Nothing what all-the-more best the so, valuable going be that has very and that products. And that's other with DEA. have

SDX after Some me the for in days schedule past. of about hearing a approval. to XX may decision speak required you preliminary prodrug issue recall DEA's the The Serdexmethylphenidate

recommendation final At its and pass made the that this that the is such recommendation happy Now, sent investors. our that is at remains is determination that's that and FDA on will to be to a along from we a DEA. to time shareholders based confidential time, potential

LaDuane Clifton

XX to from that's days Travis, be And when? clear,

Unidentified Analyst

approval one The time format have we're better. From we we're glad a submitted Xnd, people's really This some this of of here. lot actually, our March I date, from spend one next happy was I'm somewhat yes. to question so analyst. on is think mind,

for here tell are you imparted certainly label things recent know everybody a of marketplace the I and PDUFA between do AZSTARYS value all personally the the you whether what and can what the value course from very is those KemPharm I the potential you view is everybody near, public encourage I've ADHD understand won't things great can you my convince date. What what I because current are. the How tell Your it was the I you currently would that believe bad disconnect I and can I it's to I good these Well, can needs multiple is needs do or tell really the opinion the for are evaluation ins-and-outs market account AZSTARYS, children. what sit in is clear successful the for I pretend of my what what do times. to about the But and and of are fully said to I an exactly all indifferent. approval. markets has capital

labels onset and be market for X% the there. differences you'll are each to that and market products here included valuable Both able from Focalin are Take the tell Concerta about These put products. be share. Look Look these and really base yet this no effectively differences So, benefit hold with guys will and look best only those roughly tried right just Focalin XR and and prodrug them is go generic from are side-by-side what and look encourage and at that duration, X% have XR. and profiles and major which different for I most have brand about that generic these the height I are look in They're of at look about for the in two two Concerta there believe weight. and very highly sprinkling to phase. side, at label about things differentiation the now things name. AZSTARYS they methylphenidate still pharmacokinetics share. would X% onto a and They these shares cheaper is a market have graphs

know So, own I'm generic your X%, you anyway, that then branded is really $XX.X X% think to think we trying there's alluding to marketplace or does say market market. I we X%, X%, the Well, of X% have same we here think assessment. as Do billion it's do to come a a to mean. what this the and

I the shows. disconnect So, really and between value what is think the it's proposition market the

So, our what that's for what lies. focused at to at press if label. I and is of release belief would we're least the available Roth at forgot everybody for presentation was in register the and the you think do I signup where end the on our go disconnect say value share Conference. to And It that have the label we that a conference. the going is that

walk on going it take call, I'm to to forever. the not can detail, in through it do this now. I You label listen it'll

your you will that help certainly exercise So, there. think in I

is different kind is in with approval an question Another a There of milestones. agreement, there Well, associated here AZSTARYS. this, milestone is we of also license sales to KPXXX. the of number in pile relates kind also milestones that for other this

us you to We you. tell allows giving are what GPC

the go isn’t strange encourage a space. have So, we're at in of you type ordinary, agreement this much redacted to also deals. you I confidentiality, public we to licensing I that, to look other deal. licensing under extraordinary, encourage a or is very typical This

are. fairly Go ahead, feel if you want free. So, what close And those on breakdowns guess get that, LaDuane. to you could do probably and please

LaDuane Clifton

summarized to One -- had so first sales It's or sort we on very achieving of would thing almost dose curious or I we structure. they say here, prescription have in questions if add, sort simply I are one Tiers. based first of specific I simple certain of just would the milestone that

you amount fancy. So can't the a but achieve those Tiers X nothing milestone. When of certain in again, we you dollars disclose sales there's exact achieve for year,

you to sales. now contributing have gets approval, it kind very it KPXXX you and each AZSTARYS two reach reach because the arguably would effect sooner probably plus of that's got you we're able bring added sales If sales KPXXX So, simple. taking then to Tier, products of into and

it's very simple model. a So, milestone

Unidentified Analyst

Or there missed on Very good question? is else anything believe point. who I that

Jason Rando

you covered well. think I No,

the AZSTARYS. XR think it book generic XR XXXX in Focalin million. on about around had of around and I terms as label sales, comparison, $XXX Again Focalin it, we differences label when patients data of the is And Concerta. saw Concerta. I to think of approximately amazing believe sales I this to know for a is the proximal way benefits potentially from there million Similarly, XR, Focalin had XXXX. again I sales range is in in $XXX

wanted So, numbers on to that. just print

$XXX sales. You in two you're products, million $XXX combine million those to approaching

our with to and generic making Okay, AZSTARYS get you and able comparison, those in kind position to would do do able what Focalin was that think Concerta of be sales. again label

of CFO's well-understood. way not a I believe, guess. seems peak to share that's saying be that's my So, market

LaDuane Clifton

the we want making with look we differentiation to Right. as claims, FDA. going to And certainly to That's We're are a promotional the both we're as label, I why not make to not encouraging regulatory point and claiming to can convey one best not agency, at product. of here. we're we're do be trying the we're the developer, go

work that certain same a things. in sure the literally I'll there's the tell label just while has and I'm surprises -- because At do predicted came lot label they Corium out you, this to great So, of are time they surprises.

great in is think takes do well. ultimately a very it ultimately an It just it's And some think we're agreement work highly underappreciated. it some I under product. in did take being time, but will So, this I

a our year-end have is balance from is its then new So, question strategic back more should He roughly dropping KemPharm the and debt And transformed Deployment. from are also $XX last the And one zero. dint million. with about -- investors to thinking analysts. completely 'XX then. little of $XX looking sheet it you're to exact number far any assets potentially acquire? cash Capital at How apparently was be as KemPharm's since

Travis Mickle

think I actually several there's answer. parts to

one new funds, financial access course, LaDuane sitting million have as go approval transformation ways investors, organization, to that available we additional an including Of is the meaningful cap. market last million cap. is At was mutual overhang a market the that mean we $XXX same our point than $XX And I time, the to that credibility, current a many debt million can about to about that had have to market what year $XX would talking But on-and-on cap. owed as million market an we've OTC company, below to a milestone less goes additional meaningful different shareholders, to removed cap list the in us. avail been just the visibility, $XX mean -- at the this that

just And about conditions. market huge a the That so, to worry you start transformation. math, do you was

excited. doing we So, are going It look, we for we If capital that really deployment add it. we've forward, the look get you undersell about optimize to we very and except Corium. were back the transformational to we'll what to don’t the exactly be. the proves about they have everything they and that as right this scientific salesforce; have your have But development have how there's a product, the commercial and got tell of When and medical to tell know affairs They'll that. to be just is that support, including in that I party, of going they capitalize some wasn’t our time shareholders. they commitment can't be team event. tell this we there to a literature on but At really to all a about don’t so I'm the that company, is that where do access; tell all to your entire it very regulatory value do continue pricing; anything the what certainly incentive big supporting lot goes questions one-in-done we because I think me. doing can. have place still And into the we manufacturing, on. market certainly focus same well; They're would be in very at directed effort and is of and same about the so in they're time, regulatory what private convinced to public. out really we'll best It can't world any work we as what me

long product can will doing be optimize that and will or the well we So, in of value to the everything as term. we that not change the term near

has part but and value, high our add the expertise best we APADAZ at to great know in of do. this, can deploy we Absolutely, need, they difficult kind to we value. we should high a stage shareholders, any and intent value to exactly last We answer team. do the be. you looking are to new queue the at have same and later this that's resources for it's assets? the validation add of great our development development for approach, Whatever create of can at and our could use. I little should And looking technology you the what And capital will value adjective time, our approvals things we be spaces areas Secondly, again. crushingly high if is that are going we at our most

question. don’t one? that LaDuane that up -- wraps anything missed that you hopefully on So, I

LaDuane Clifton

ongoing conversation. is on going about It's balance an makes only about say with board something but us next. what's what's view think say is our enough very talk possible together it the would be of focus I I now basis I how this next real but on I can't a conversations important we have that new sheet what's not really the strategic strategic course direction Travis No, what and to it

months basis an this I we over will on as the we'll this area. the So, rest progress the make several best ongoing year be update next just of think do our ongoing and discussion in throughout provide to

frankly I right the it's direction thinking the question, So, appreciate really about. to be

Travis Mickle

Alright. this With any time we that allotted. more we can don’t questions that have for

Travis Mickle

reiterate Conference, presentation. a and will more management link Hopefully register Roth I listen few to Again current can is to again full there the questions. answer the

I think updates your found can all here. be financial

this around time. time that. thank things all At resource approval, your to still the that are those same the The the want is really the certainly for So, in best present intense and everyone company. excitement in for I great interest

So, my appreciate everyone's and effort. I shareholders thank

LaDuane Clifton

Okay, we you. conclude And will with that call. thank today's operator,

Operator

does you, for This today's call. conclude conference participating. Thank

may disconnect. now You

Zevra Therapeutics (ZVRA) 12 Mar 212020 Q4 Earnings call transcript