KMPH - Earnings call transcript Q3 2020 | Zevra Therapeutics, Inc.

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good afternoon, ladies and gentlemen, and welcome to KemPharm Q3 2020 Corporate Update Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will follow at that time. [Operator Instructions] As a reminder, this conference call may be recorded. I would now like to turn the conference over to your host, Mr. Advisor. Strategic Tiberend Rando, Jason Sir, the is yours. floor

Jason Rando

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

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

the disclaims of securities to results revise the to as Safe represent law. except Forward-looking current laws update required statements, statements are management's provisions and made pursuant may Harbor differ any or federal expectations. Actual by forward-looking materially. its KemPharm obligation

KemPharm KemPharm's complete are forward-looking For information documents files you at uncertainties website statements, the regarding can these review SEC, encourage under carefully. section. available We and Relations which the in to Investor on our risks with www.kempharm.com reports be found

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

call remarks, my will Following we Travis. to open to questions. introduce pleasure it is that, With the

Travis Mickle

Thank you, joining want I afternoon. Slide the everyone here run you, through thank this to KemPharm X. for highlights and Jason, on

things of few a Just note.

including on execute to the revenue, push NDA continue all we've plan, our continue to the as programs and continue and along, development and well debt. expenses work the meet to as business, forward address continue obligations We base partners, on our our as with stated to our with to continue

we've see NDA KPXXX. review The to last and FDA the can quarter that's very You the done. much what highlights from the of for continues

date, collaboration continuing consulting of – safety review a our with Corium, as substantial to identified a the already you which APADAZ partner arrangement program as going and announced XXXX, our Sure new really far I'll discuss of well off the for KPXXX revenue as results, Med. issues that KPXXX, trying soon, maybe intended bit partner, issue also be the and X launch a is for safety familiar to issues to same March of the commercial us, address no at our We expansion for recently our And date NDA. that have we PDUFA between no and the financial little left a the as with. to And been detail have are this, services of all our no on while to issues outstanding see to to there's KVK We for presenting only many time, future. address based more in foreseeable which debt. continue

next the slide. to Turning

specifically more KPXXX. Looking at

meeting. called cycle or XX. would just identify be there I This was a were do or could no review the substantial the of As it this confirm so, FDA with necessary there with on no last We do on to issues mentioned, raised which agency date if to would to tentative August any are issues, December also X a safety issues. for our be year, in only meet have concerns was late meeting we that so that meeting approvability

and be is is then be point will would That effectively is order to happens progressing. whether how know approvable what sending explaining we approvability way, that and from the along that meeting product to shareholders or essentially either So investors along with the you FDA the on. know to at for in supposed not

able related the order quota would of after that activities. the good, of for ahead be could to to multiple Corium generation ADHD, so scheduling scheduling to achieve market a launch viewpoints their dynamics to all launch. for KPXXX. challenge also date as provide be their plan call to a Corium plans have are with them do DEA that overview have still roughly really a be reasons, date on XXXX a at point. process announced an commercial has second is They be midyear, what on the This working with and Again, We XX-day to possible. expected and We soon been to commercial announced have product targeting and in as half

to on now agreement X Slide here, KemPharm. and Turning the that between agreement Corium

We great – in build products on not continue R&D endeavors our the related able has to that internal to on adding drugs. develop to our partnership now KPXXX, we with services in that from additional in support their Corium position relationship endeavors the put us staff, to pro other are this

doing support expansion what publications activities, were commercial upon such. which their in and medical So we include manufacturing, scientific to this an them already already is affairs,

So the is co-support continuing see a to on substantive it trust, there. the you here. were, kind financial is This of commitment as relationship relationship build. based can fairly The

as to we past on a commitment expand party’s the Certainly, up relationship. support, $XX.X Our PDUFA about both excited date that million very and for shows the that one that are full-year. we side

Sure returning KVK Med the next the to and On slide, agreement.

appropriate are once script switching This APADAZ where efforts to product appropriate gauge a measure on like from switched and program expand research for an And be intended the as in to announced APADAZ, information or will as is physicians it's to the that to new particular as to for to much pilot in Newly situation, abuse-related happen as will that outcomes be perspectives effort do these used around a educate and a with will well we which about those be successful. able would products care. those product look has the identify very in actually potential further abuse research a like hydrocodone is program’s tool more referred this something name APADAZ. to with. what pattern This create when focused then

Certainly, can the annually call summary has the in with more X over, tablets a capita now hopefully, you it's And to CFO. that, has Clifton, the some the This date in in XXXX. program here, acetaminophen type opportunity, for United LaDuane I'm will except officially Alabama's to turn for launch the LaDuane? as and the great per momentum see going And good is APADAZ December situation. in up project. comments, our highest wrapping we've So Alabama. some launch actually described, than actually utilization of It XXX the hydrocodone unique products. States – the rest with million the to a dispensed in

LaDuane Clifton

Thank and you, Travis, good everyone. afternoon,

X. Looking ahead to Slide

of As authorization you to company stock hold company's announced to we potential meeting of X, reverse for know, stock. October on going stockholders that is a split the common obtain special the a

November proxy announced been statement Just exercise meeting, filed matter. We to on with the this voting webcast. attend has that been review has X at Monday, special place you on this to your SEC to that past more the the details via for shareholders rescheduled how we take now meeting on rights XX AM for that and to how encourage

and We mean have what company, a for split, the stock address of it number hope received a questions a of from of could those few reverse to about shareholders the I authorization today.

with restructuring following make any valid proceed be reverse make our split that stock shareholders intended of and tied reverse the and the obtain not This in If the to decision One Directors our meeting, meeting order first meeting, the reverse such be would an then to will stock we for debt be to immediately. for a at would split authorization affect split to if the make the clear is shareholders determination and is that close at items to to of to interest months a the the of that effective again process, seek approve stock upcoming closely the a also both authorization special to Board of would a all. stock special XX reverse effective. transaction in to need when up best split, making authorization company and

least relevant stockholders bid relist that $X $X at of on the is for NASDAQ initial consideration both the requirements Market of to have include per important share, and price least a that listing equity million. Another Capital we KemPharm at

actually more little million. we which stock $XX XX, address than of then we we would $XX.X stockholders' had which reverse of cannot quarter means to not If just a that relisting NASDAQ. would is address of As reporting, deficit we making need transaction this split enable September effective equity the a balance, any undertake a million, that swing deficit, the are now a on

to We to have Turning Slide X. have both now

split the us if and predict split have impossible to allow company range received also the determination of the And will ultimately of the stocks when about bid to impossible but reach shareholders, made broad predict that that to will not range extreme at best to and in and the of the that have We of transaction, the sure therefore, stock its necessity, all, to $X. carefully reverse am reverse range. the price of prevailing of is event, represents I it questions a the the one either the there's could order are determine that ratio making split minimum a most the interests is be likely in circumstances whether intentionally transaction scenario, It considered. be any in affecting. reverse timing

goals, meeting consummate the that timing, meet terms for successful restructuring ability very we the move will holding a of Regarding lengthy. quickly transaction administrative debt to our process is then to if are special in will a the the the transaction. need such we And negotiating

deal tool including us, and this negotiate if to to so dilution, potential to Board. authorization now the me, our operate that and of about right we needed have shareholders current Ultimately, Travis done. all our are are seeking will get We the this freedom with available worried

not we you. disposal equity have degrees while We are restructuring stock will all either varying split require does debt options of dilution, create asset at shareholders the together this dilution. or though, of a many point, our that At for with reverse itself

dilutive by repay done overall future financing. the focused component. of a dilution intensely capital, which the For future cash value flows a on but of minimizing year of the technically Ultimately, earlier taking we dilutes we to cost to this as a certainly converting are debt-to-equity assets was example, equity, royalty portion is financing had of

upcoming a could of are also provide OTC. process than with NASDAQ have institutional that have relist while the has access the that it value. If working investor KPXXX, effect our to possible trading currently to Finally, to important on for shareholder milestones keep costs on the benefits. our larger prior are unlocking Regaining it's is base through, it we there potential we are in listing always associated mind to the to while there

and costs have analyzed. benefits However, be to always carefully

to XX for our financial we'll attention on So QX now XXXX. and focus the results turn Slide

G&A derived Travis the is As which $X.X we revenue from quarter and diluted XX% consecutive XXXX. expenses were basic of million, an $X.X loss with We revenue net share. year, to we March primarily services. per manage last This we and services and Corium, our $X.XX and of revenue, expanded had those We of operating QX consulting with arrangement of of of items. through XXXX QX of as our R&D expect reported fifth continue than a million, than more was mentioned, continue reported carefully loss less both for our to

to compared of $X.X cash burn million cash decrease We million, rate quarter, September Turning of XX, of XX. ongoing with slide. the that see per as the was which of in we $X.X $X This our had a quarter. total was June next million to prior line approximately

shares Our to could September to of cash cash as XXXX, debt Debt million, that restructure XX us debt runway were March prior our take further. maturity rate was as if XX, date to approximately and we're up million. us And the yesterday, $XX of able XX.X XXXX. continues the to of date, outstanding take run the

next through the process. and the to, to debt as we've work continue actively On restructuring already we alluded slide,

offering, several financing. right repayment an existing or under KPXXX the has potential value through is replacing some is with extended our priority. to license to working transactions, have options various these long-term we're new seek debt upcoming process that that as payments or milestone sources, We royalty as right the of solution our a other of to be complex. deal or combination debt proceeds secondary The from that find such here, transaction, options, outlined may is the from some converting even debt become equity, to agreement, create maturity, we've debt most the ultimate including And it ability Getting ensure of will we available. option likely series the the that or first

We also we enable if a want to uplist NASDAQ to can. potential

efforts to progress. updated back call you as With I'll continue keep these turn that, to the Travis. will We

Travis Mickle

a year before, a with Thanks, KPXXX, like expand a less product launch and than the December next differentiated for March, I on highly from and with summarize KemPharm, we the in and a PDUFA need $XX mentioned market upcoming, approval from meeting X then up labeling date LaDuane. of kind this. very large in away product to we're the potentially a To of for milestones, steps the have depending as a in million FDA

the to build and to Med APADAZ prepare now, and addressing the future. We're looking debt, KVK near possible, base business provide reasonably also looking all for continue KPXXX to future, as as revenue, IND, We we're the very file Sure well by as pipeline very looking launching a beyond it more adding you We're soon the with the update that ahead. KPXXX. in detailed something in near as luckily, with

presentation, As able tremendous believe been value there I in summarize hope is KemPharm. have we you from our to

is see we value right As that lot untapped. of it now, a

to example, Just as enterprise this. demonstrates current an highlight our value

which markets, which OTC, measure is fairly on to inefficient value. a in are capital NASDAQ We market, that relative the other or to the

need than to potentially it provide continue upside need the that capture been is our once more value. our able a has to and that on we that will in address it need we And be being so, to we uplist, to ultimately, really plan far way the OTC. to debt, meaningful value on create that we believe opportunities And execute to untapped,

going along. we So we'll we the we And to think example advance and as be plan, we you future. update where see of that's the just where continue near will one in

that, with may and our completed, welcome So have. believe presentation is any I you questions I

Operator

so much. line Livnat of comes Your Thank from Wainwright. H.C. from instructions] you the Oren question first [Operator

open. now Your line is

Oren Livnat

Can me? Hello. you hear

LaDuane Clifton

afternoon. Oren. Hi, Good

Oren Livnat

obviously it’s Great. right. Making That’s all you. sure

can I if remind covered the us the versus potential December just what XXX, is type in that clue items of status agenda there you review review, or of regulatory into the regarding us might Just typical be X, this late-cycle Or the mid-cycle issues talking is approvability negotiations? any stage, just we really regardless with? might are Thanks. what labeling of type coming this up of you guess review issues this And, be difference? at Are about label? these late

Travis Mickle

for remind is under thanks and perspective, – the question, a just actually remind Oren. program. the I’d regulatory as known to Just from everybody. KPXXX what's

that follows waiting So sponsors intended new that ability the it regarding – to And the as molecular the program to find program in to date agency is was a the entity. provide guidance with feedback get guidance timely out as whatever is without labeling, regarding is agency identifying safety if until regulatory the were, intended this PDUFA the issues real fashion, to is non-approval. mid-cycle a the reviewing, well proven as was identify there any on issues any be, currently space. may But regarding would concerns meeting major designs, immediately it the as study that highlight this

meeting again really attributes, from we we really understood, and The that duration really expanded have were kind the the since was there the they at were to that reviewing issues clinical and time, no unexpected. So, of that the things of product safety, – meeting but and nothing is approvability meeting. know mid-stage that late-stage issues that that related was regarding then the

from working hear on the safety and from the on agency there be and efficacy, opportunity then the about have we'll to they'll now, the views labeling. So their

we know there's know this major studies, product. it is efficacious So in told clinical and methylphenidate-based they've our concern. We safety again, was us no already a

So we on track. that useful us. also is be will every see feel, that meeting helpful indication the what right to we're agrees this again, with and the But agency

Oren Livnat

really the was or other prior initial And portfolio. that up – said that consulting it noticed whatever Corium, first in future the Separately, and what $XX.X encompasses. KPXXX read with you understand correct? that agreement, to Corium to remaining I'm I release the wording $XX.X trying I interesting. agreement was in the Okay. products current regarding of just expanded all, on million, can as confirm or mean, I includes million the or, It press

wondering, potentially or this I’m you stuff aren't – other also So does products in some guys portfolio with yours hopper? their that involve originally, working them are on maybe that

LaDuane Clifton

little could I'll question, why for Oren it try understand take the be this Yes. thanks and a I Travis. question. so confusing.

in quantity license a kind a the a essentially underneath them did reported we KPXXX We to us So, hours. revenue price we agreement. have of fee times include number It provision quarters, basis, allowed right? services on provide of generated work that that had prior to

paid You get whatever.

The they KPXXX there So was arrangement the us of arrangement the product pointed to of sort what products visibility. or as more current it just that that their flat okay? trying where have, has converted Corium, either prior under regulatory arrangement, into services allowed And out, then, which activities those support, piece But were of agreement license smaller new arrangement other okay, contracted our that support and – to to us – piece some products. the that's to that that you a commercial is it. in with of with related future gives actually and KemPharm so the today, and commercial bigger were in they we really then specific provide pipeline have been a fee that on for development not them to us assist are already is describe

not products to staying to because these work assist them. may they pro-drugs. be us so, ask And It's on necessarily even

there's XXXX, so revenue both see visibility again, that we’ll work orders provide to an to the And up to And from through and we've the providing period. XX, of at then extend out have March Corium. us, least that's expansion potential so been what of therefore revenue these those – that

Oren Livnat

any before And, on of with to essentially come date? in us, follow-up there royalties? milestones agreements or milestones just Is remind one that Corium regarding that. economics your PDUFA to your change there that deal any the Just are or more

LaDuane Clifton

Okay.

was of provision the the of milestones part there, all, intended any license no for change support agreement. us. impact other date. was there no, the second get and or first milestone of then, expand KPXXX really other to This So potential just or related the amount approval is next And PDUFA they upcoming the would on the support to the from commercial to

Oren Livnat

I KPXXX may you I speak every or world schedule, regarding speak, if said And them things just script to hard of at greedy, Corium in potentially the call, you so the And so to and did announce coming earlier were making themselves the couple good. to it. and most pre-launch. it Got of shadows, there out to a that little ask a I'm be least, to bit all wondering

things, factors scheduling Thanks. related? gating our actually So what potential And such are I'm KPXXX potential are party? a wondering they regulatory just than other what coming-out for

Travis Mickle

for been organization that there's is regulatory-wise, the Again, nothing to the us Certainly, so Yes. wasn't transition. issue. update that Corium in

As a you to adding team. commercial get team do to to significant would commercial that a expect, to And even lot of prepare they're this point. had work

So, to directionality a high-level. was something to opposed a early that provide was something we a just stage wanted as with update, at very and relevant informed that

So, I what both think Corium do and that's that. to have KemPharm decided

we're point. think I reaching that

a on Now just to settle we date. have

Oren Livnat

enough. so Thank Apology you for Beautiful asking questions. very many much.

Travis Mickle

Thank you, Oren.

Operator

would to and showing I further CEO Mickle, turn Instructions] Thank of President Travis you. [Operator the to Okay, this at conference no questions KemPharm. am like back time. I

Travis Mickle

for and Appreciate plan, – it to continue time. thank provide continues updates as before we'll Thanks, unfold to your execute to our like – timely I'd their Again as us. everyone. we time today. everybody in fashion as to a

Operator

joining. all today's gentlemen, you, concludes conference speakers. Thank Ladies call. Thank for and this you

You now disconnect. may

Zevra Therapeutics (ZVRA) 31 Oct 202020 Q3 Earnings call transcript