OSMT Osmotica Pharmaceuticals

Lisa Wilson Investor Relations
Brian Markison Chief Executive Officer
Andrew Einhorn Chief Financial Officer
JD Schaub Chief Operating Officer
David Steinberg Jefferies
Greg Fraser Truist Securities
Daniel Busby RBC Capital Markets
Call transcript
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Thank you for standing by and welcome to the Osmotica Pharmaceuticals' Second Quarter 2021 Business Update. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions] As a reminder, today's conference call is being recorded. I would now like to turn the conference to your host Ms. Relations. Investor of Wilson Lisa

You may begin.

Lisa Wilson

can today's Welcome Thank Officer, Chief XXXX for Operating Pharmaceuticals' Chief Andrew on quarter Officer, JD Chief Osmotica update you Osmotica. Officer, Einhorn. results This call. months call Financial three XXth, XXXX. Markison; me accessed Relations operator. business for Investor press This of the second and be Wilson, ended website issued Osmotica's webcast press a Investors and the to is company Brian are afternoon, the the call This release Schaub; financial a release With Executive section detailing through Osmotica Lisa June this of at

call like law. Actual remind not including of Osmotica and future available expectation, I with Reform these we belief, management statements the specifically Act. These any intent SEC. that uncertainties projection, on Private started, forecast, release or to are Before statements statements risks intent forward-looking by and Osmotica's anticipation, obligation conference based be and Litigation in future statements. may may results the update from everyone forward-looking noted as materially those as company's of express projected as statements to information the get afternoon's today defined our this performance. involve filings events future to by and differ forward-looking those the are or a Such statements press guarantees required would forward-looking in disclaims any except that considered regarding performance today's made forward-looking on Securities

adjusted refer such may we measures call, as this EBITDA. non-GAAP During to

our tables see will press of archived our of release. the for on net For website call income a to end at adjusted reconciliation or at available days this loss, webcast XX The please be of the EBITDA

made press and this that, announcements call then, archived on For the have replay to topics And the discussed, Osmotica XXXX. August related over reference XXth, Since who held the webcast, of I'll may releases Brian Osmotica's Markison. those recorded listening SEC was most may so the to call please CEO, recent filings. or be turn the benefit to and company's with

Brian Markison

Good for afternoon call today. everyone and joining our you thank

in took we late of In we announced clear our a been the of quarter, company. Pharmaceuticals. purpose divestiture major for business entire the to step to home the of and transforming has sale our Pharmaceuticals, RVL During delever June, The singular the runway this Alora Upneeq. legacy

and seen increase providers we brand. solely know to XX% that X,XXX the expanding response Upneeq QX the second importantly, as are as is nearly first ptosis focused product and unique already a for in market the the In steady patients first of treatment terrific and had Upneeq, on of success only most in and prescriptions. this for quarter, new from The to the start. the is over the We has asset. a in great FDA-approved an important now opportunity product prescriptions, truly paid adults, quarter the increase acquired been off we

working territories assuring with approximately pharmacy. customer of level with franchise only a seamlessly can should Pharmacy Our eye commensurate noted Upneeq RVL expectations. exclusive thus the purchased, XXX be care way now our be service has It that our is

we Santen. to as our our partnership we growing and work is the look capture highlights sharing This this of Upneeq catalysts. near-term an some market Aaron the aesthetic on in in We also we will research through and to exciting more Later and time around JD in strategy. consumer recently recently call, both value framing information of with evolution brought Green and the completed finalize lead more the US our go-to-market forward to provide our world

working to agency suffering study from to an for patients it also submitted on III to development amended this deliver product MS for the protocol potentially benefits We look arbaclofen can and forward FDA. meaningful the Phase spasticity. with recently We plans the

to Now, turn like over the I'd call to Andy Einhorn.

Andrew Einhorn

you, Brian. Thank

As P&L different consist business into the in an rules, Under expenses related assets and results reporting The the of is face quarter accounting divestiture business' that G&A Upneeq our and collapsed we're line the liabilities the items expenses for of our legacy business. financials results a are on opening to than operation, single the our past. look revenues now statements. and operating this as generally financial very the comment, accounted meaning discontinuing of

of payment the a partner revenues second of and Santen product Upneeq. $XX.X million for for Our our totaled Upneeq quarter million Pharmaceuticals license milestone of from $XX sales $X.X up made million ex-US

expenses As in the attributable no was comparable launched of period the sold Upneeq revenues to of Gross quarter, Upneeq primarily during there $XX.X were million. Cost year. were $XXX,XXX from September profit again last during was for general goods quarter XXXX, and the Upneeq. Selling, the broaden Expenses administrative the approximately spend into eye an of of Upneeq company. sales reach the marketing activities reflected to our quarter the professionals of expenses our force consisted to care. promotional we during as XXX launch expansion greater running and and related

promotional increase deepen ahead, as quarters these the to our expenses penetration to and into in care we aesthetics. expect in launch plan eye We

align R&D Argentina the Buenos to During and termination development expenses curtailed Aires, employee took the totaling in our reflected million quarter, profile. of resulting the cost expenses we research and post-divestiture for operations better G&A $X.X which quarter. in structure our We our our are in subsidiary measures with

quarter Upneeq in million a candidate. the arbaclofen small spend we our charge follow-on and the expenses and $X.X nonoperating subsidiary. on development costs consisted Argentine to Argentine the disposal recognized of Additionally, of project amount $X.X a Research and of of closure restructuring second asset related of million

$X.X related approved our the second we recognized delayed quarter anticipated would a the write-down if arbaclofen impairment launch of from charges of previous million the be launch During to asset, date. of which intangible

business net Argentine assets in million Net quarter. from the earlier, expenses the legacy operations quarter, $X.X had subsidiary. of adjusted million, in XXXX quarter the our of was second quarter. the for As a of EBITDA the to income quarter Overall, the $X.X primarily $X.X operations loss of XXXX. nonoperating second other the disposal an discontinued mentioned of $XX.X in of loss we million of second continuing our of reflected fixed from from EBITDA loss was our for operations million Adjusted million $XX.X continuing compared

As XX, revolver million cash of June XXXX, under cash $XX availability had equivalents $XX.X our of million. and we borrowing and of

costs. principal JD. to under had also over I'd $XXX.X net term million like our borrowed We financing turn that deferred the aggregate to of call loans With amount

JD Schaub

totaling XXXX of at QX. more quarter. a makes truly ophthalmology today, in QX, end for up supporting Andy the details Upneeq a as XX%. continue awareness with launch to of tactics our we momentum, and grow than which everyone. prescribed highlights by expanding on as From the perspective, we create I'll more you update building Thanks, share recent over additional Upneeq in makes to good afternoon, July, prescriptions than grew prescribers of up on of who about new Today, least ocular optometry we once, while and as the XX% expand expansion care, the X,XXX have helped HCPs, recently have In team And QX prescriber broader reach category sales remarkable builds. aesthetics. The Upneeq in X,XXX breadth eye XX% XXX launch. in July, base sales mix completed approximately continues the remaining professionals with now the Similarly, nearly the our total

count by XX see patient of seeing and Though higher in September, prescriptions beginning first their also start, between Obviously, to continued and group thrilled estimates XX than time of routines prescription filled days their bit quite continuing tracking of build a effort practice. existing who adoption on early mix the and our and preliminarily as as therapy at our from forward, be patient XX-XX of are an early to expanding appears hover October cohort with signal to refills. patient. it growing daily incorporate We while and evaluations and in part XXX this focused partners are ECPs, the many a moving those each per an those count within days patients depth of our view behavioral encouraging a early working the are first of shift to lid remains same utilization last importantly, XX prescribers a and market per utilization, about annual have unlock year, around to average of on holistic stickiness value ECP we to to of reach remain north so by on

quarter being ages of by with the age well to household tens market the for the including adults, patients the during and/or of In X.X a We the and to over than of market research that highlight of key surgery research opt we market between are something toxin-induced completed and our millions ptosis. supported tip agnostic and who results XX,XXX understood, is income opportunity second The severity be short, experience significant the largely consumers. of consisted for which of Upneeq annually iceberg of corrective Ultimately, part qualifier market historically. building is we believe only been which adult deepen fairly the women blepharoptosis, greater and/or Obviously, is to acquired million a the potential opportunity lacking market's XX, has that the ptosis. the ability prevalence, this is $XX,XXX. effort importantly, XX understanding of

market believed product their XX what lid. an normal. adult always level outsized self-identify Specifically, low-lying research about would profile fulfill or in as they as Upneeq four appearance than believed further ptotic identified or having presented of Obviously, were XX we of unmet have need by this regardless a and eye whether after with of some need. women the highlights is and bothered opportunity ptosis six of more Moreover, a

forward, of we number supporting catalysts accelerating As look we a growth. have

eye true dispense our initiative and meaningful and this of began ago, efforts to us tremendous we been utilization a care. partnership offices The has at purchase see deeper at physician strategy several model Selected level practice to a Upneeq our the First, practice with feedback in to early their directly drive a through providers. from weeks patients. with as and we dispense allowed were the pilot care point

aesthetic Additionally, the the you launch in months towards this us will work expanding as in begin next ahead from to year. hear the market in more we early space

With with tremendous practices ramping group expand country. opportunity the see the upon up these eye engagement our these into we upside, and months. has we to and of updating treatment, flow the KOLs In of and these specialties I'll a call base catalysts numerous refine effect about utilization continue an to which a of almost our utilization drive With the amongst future Brian. excited see care, months to a are continuing specialists, strategy non-invasive immediate to prescriber based to a to ahead, patients. incorporate and with We turn the awareness on the positive patient key closing, in and influencers the incredibly across and of core on clinicians. the daily our RVL drug tremendous and to and increasing Upneeq discussions are we again everyone Upneeq, throughout Similar that, non-core back look progress couple forward aesthetic in

Brian Markison

Andy. Thanks, for questions. Operator, JD ready we and are


Thank David from Jefferies. you. comes Steinberg Our first question of [Operator Instructions]

Your line is open.

David Steinberg

a Thanks afternoon. good and have couple of questions. I

as of to first it a plans do transaction force you terms you cost think we know do you've is is with operations? on have sales Brian, typical patient loaded time? and in with you early have fully -- You XXs in in their promotions last talked more question, aesthetics. the what a And patient of same going financing sort do disease. profile, was what's as when how at I you the up. check patients will should What typical patient ramp in gotten full mentioned XXs At expanding And close forms about point of sort in close? severe the into exactly Alora, profile the more the What's think fund about So and Secondly, it structure or or this spending spending? place? of see scripts, of Thanks. when the I then to when guess place

Brian Markison

All Thanks, David. right.

patient profile. what last first do that think is start I'll the I'll And I typical and your with is, so question

product I we and steadily age was of the patients age get introduced we've talking to age the has patients September year, or about needle out about we launched ptotic of first average of last further think and mildly there when I it think the are been as promoting predominantly the XX in which and that year. as dropped old years this old, our our female And years be XX around average product now going moving the is population. we're particularly into younger that

we got for and little a and I elective they on severe the more a think, this had milds I up. were beginning how on are are waiting think the breakdown think And that strict now early thing but could other were bit expand to coming in, that that's JD have surgery, patients see I is, what on coming we're moderates a in, I is don't ptosis. the shaping few those

JD, So color that? any to add to

JD Schaub

probably we all is, number in severe hundred think that's prescribers every for or new couple week see And at so right the it a are month we probably now, I'd who David more XX why and continue we're pretty to just and time so most add consistent I noticeable has of many average of been new day, around week. add first that every in continue because to using age those new adding patients. prescribers every many prescribers every terms

the throughout have in the their own the these their up assessments because counterbalance starting conversations of see we more country. of office have with offices open to and of begun folks and where a us in think with doctors to to and that those see and some change that dug patients, are range more really broader and paradigm I lid the we're

continue market. think in of obviously, over see really number as through like the that longer forward terms I will, factors I of think, to of we'd the this low rest I period anticipate, that So, up then a year, time, in down And would number the a tick XXs move to of opening down. we seeing

Brian Markison

have David's a parts to of question. Okay. more And well still we couple

you the question asking wouldn't if the mind again? other part, David, So

David Steinberg


once fully the at might other other was curious structure going sort said the you financing you pieces And and do And So was cost close ramping to Alora? you're when operational it, in place you do of when were a you fully fund are look promotion. close you're I operations? part up Upneeq. what what two like plans have spending loaded to

Brian Markison


Okay. Good.

the operate State the We've That required. waiting facility. in last been license day. to to is an Georgia inspection So in is a the inspection for plan any the grant close process order week. happened to Pharmacy with of for Alora Alora to them manufacturing where Thursday Board That's

went well. we So it and -- understand very

could but right to respect hoping we the close. number to the a of drag bit strategies we say we're a the any have we discussions today, when company. frankly, quite Board or refinance although of that but give financed parties we are where are it. among Those I really that's So in only conversations control talking with we we it out of to are would and going out thing quite a Pharmacy, alternative well coming assurance are no I other good more close over day, but group are that outstanding now no we can State be reassurance very plans, because, with With of financing lenders could will use, comfortable to

rate, month. we're maybe OpEx, good I looking if I little If So, justice around we think there'll run have. a on sales some about I R&D, less But different that we're $X say immediate a which promotion all million force, rough But to around feel early upon disclosure. pilot of maybe be work a depending fully sensitivity purposes G&A and we all-in think at now, direct-to-consumer for feedback I that really million that to then month would levers return. but would we the is a have more, could doing full up, $X scale say an returns little that loaded, you

David Steinberg

much. very Okay. Thanks

Brian Markison

David. Thanks, Okay.


Thank you.

Fraser Our of Securities. Greg comes next Truist question from

line Your is open.

Greg Fraser

could the taking quarter. demand third comment so great a off if for said questions. I start. to you that is prescription on quarter the wondering in seen you Hey I far know Thanks you've guys. the was

provide in Just hoping, you such July. growth could some color quantitative month-over-month as

JD Schaub

is mid-teens June And This we July of in JD. I'll saw Yes. prescriptions. start. I think over growth terms

build here. the obviously, with think the summer given continuing to So launch momentum the I and really holiday of still heart positive

Brian Markison

started accounts the few July. And the in shipping other a we month dispense of factor is, just direct to

a of So our them off-line, shipped few directly. we prescribers took product

believe future and more going go the fairly But or call going meaningful. going value track And would of this we you really quarter, that share the as break the to to we so to to component to if can to ramp is we're you this we accurately. how us the I forward, we're out is work out quarter. think the that guys in get of have latter So be going buy-and-bill all part it third begin then in into it's the fourth as

I be the would as again, July considering So we to was August, And good, darn holiday. good well. said, as expect of think JD month July Xth pretty a it

Greg Fraser

it. very That's helpful. Got

piloting, practices On cost? price the details you are their that And the setting you're physician of works? how acquisition on some more can the dispense Sort customers? the how what's model give model us the for

Brian Markison


So JD yeah, the exact some then and details. it let me help you will of frame give

is this model. now. in piloting right what That is now we're the dispense states direct exactly, permit that So,

For and prescriptions it run model New out and calling of would year, that's pharmacy. the states permit different through the share, would and will York, we're purchase virtual where a more a do that as inventory, solution, value rolling our the around probably that prescriber the not technology such Texas of be we first

direct So, of where part we permitted dispense that component kind of like but now. the states it, for

So JD?

JD Schaub

folks not purchase. and really there, at this these we're the of that I provides, using the got looking that quarter and handful elegant of within in think I to we're the how the terms but about the opportunity lids that excited of is of in patients, summarized working a platform just these partnership they well. of there offices, No, We've from many and the talking is a for begin I margin the pull-through a this think, ordering practices perspective seamlessly profound programs, full-blown offices we that process the that and dispense just did a adults. very Greg. the Yeah. getting entire really to engage our really flow kind got the the and working And highlighted We've so concern and solution with just really to about off ensuring overall getting how first Obviously, day-to-day fits that in the borne infrastructure so research direct that sort with two second think which Brian ground. of team office perspective, many from to was in shape a with market out the of

Greg Fraser

Got it.

That's helpful. Okay.

JD Schaub

think it second about the the but I about to I was part your And today around subject way baseline of question is margin. obviously think would margin. change, XX%

with So a price. the for And $XX business and is at path between mind. model and per been box this and look $XX simplicity this if $XXX we've we've you transparency look purchase chosen in – somewhere month

So pharmacy. trying think in patients pricing, that pay anticipate to the terms consistent we of I out what coming sellout of keep with

Greg Fraser

very question. or my to care cases that if patient professionals eye had get eye Then it. the COVID are of access visits professionals? docs care now able you're calling the you. question on to how has calling the But on the in ramp that That's are a Thanks. reps your with impact many level an expanded on helpful. last you is And Thank sales force? Got curious, two-part with just the

JD Schaub


of covers And XX. XX,XXX sampled number, So our end about through total of ECPs. between XX,XXX. is off the XX,XXX I July, and work we've about now just footprint The

introduce there. of to front So reach, the of that the and the get of to good ability product build the in in I to growth the the and offices from condition, think begin team, and these to expansion of, we're terms progress making

Brian Markison

now, respect could little we're pullback take there's to that with that And bit worried a place. COVID, of

us. We of restrictions now hurt to we're haven't little close we it down mask play, it. aware could But as yet seen obviously. But it But haven't monitoring But We're into us now. right right it. we bit. providers more of seen we're shutting as come acutely it see, a

Greg Fraser

Great, thank you.

Brian Markison

you. Okay. Thank


Daniel Busby next Thank comes Capital you. of Our [Operator Markets. question from RBC Instructions]

line is Your open.

Daniel Busby

Hello everyone.

Brian Markison


Daniel Busby

pushback? a professional questions those the are a prescribed first is terms is care the who Upneeq? period Is samples for kind what in of there? last or professionals period there last the building then, time, Maybe typical upon standard themes couple eye of second, between of those average questions eye And that of become any And Upneeq yet haven't instances an care first months repeat or they when transpires of prescriber? there common

Brian Markison


there question, So taking any been the first pushback. part really of the hasn't

I everybody seeing think, is what gets rather it quickly. we're

sampling think on themselves eye care our that gate, out the and of families. with deep lot pretty providers of and I program a tried broad it their

and where not the it routine to So And think eye volume we going working roughly has begin I is for examining to into into drive the the want care. really prescription practice common now, the real work been hard deeper your practices. daily lids,

practice be here, situation I eye, because altogether, et not a if with ptosis think for aesthetic dry is is mind. you've busy launch macular of will different when that into coming we top very treatment. aesthetics cetera But glaucoma a degeneration, it dealing the for for in eye patient there that's got care,

there's very pushback. if So any little

I value in we've heavy share very developed is the are in partnership us I think or the buy-and-bill that the programs play front role with practice. will And a the lifting deeper that the major going driving it if think provider. you or chore into to of

I So that? anything know, you want to to there's JD, don't add if

JD Schaub

right? far No, of building on the on I sheer number at we're hand, experts prescribers think, other today, it's hand, why it put the important this there but it so ptosis just is in that remarkable So, few the There's, obviously, when out that just pretty you context. very one context. hard market,

throw comments, easier There's start it, and take into at it, Brian's that it's beginning to then, each dispense, spending making willingness it And these seemingly use relevant time, And are research to to now clear physician of is it build us to need and that that identify. all through tactics around bringing tying about desire as, say on this partners a conducted. something. taking story to our think practices patients back. think I market such to look so And really that I a we direct step try and the

start hear You to lengthy what in the of circle back eyelid like. lamp last looks this a office weeks run through their really to through Have a impact get don't there. of diagnosis. has lot patients my wow, have is the behind you and here like, slit number And that reason does real them the of a these they're regardless particular several running in over

those the the encouraging. on are so the And some the of depth And now the force partners right early is things there through. with pull that and I I adopters really perspective team to think our are out field and that from think focus laser-focused that time spending

Daniel Busby

care Okay. to And how pivoting aesthetics hire you many thought for year? reps the to rep hybrid into sales you we put more maybe professionals? a that calling aesthetics launch be have of of, a more forces, you approach opportunity, distinct any both think should would eye more next single need may of this Got where sales it. or two as, anticipate and may on And kind

JD Schaub

question. good Yes,

we of the that out territory gives then throughout there at as from pretty right optimal time what and And the need the around perspective, this MSAs -- in reach focused to picture adding a geographies from two forces. as going on would a distinct I key means builds trajectory today in us we as the filtering in an what that XX good other over like have and think, I a States. and of then So number we're terms look number coverage looks of some we're them from the large go and United move in we how think that. which in And I

Daniel Busby

question just Okay. discuss update protocol? any the on amended next Arbaclofen. last for me on should program? meetings set the to Do with expect up FDA you we Great. And When have this

Brian Markison

Yes. protocol The days has to submission. to agency respond XX our

Arbaclofen. think the dialogue of the end agency with a September, at expect in the next I of to month around we would be So end at

Daniel Busby

Cool. Thanks. Okay.

Brian Markison

you. Thank right. All


any I'm this you. like no at to questions back showing Markison to Brian call closing Thank I'd turn further time. Mr. for the remarks. over

Brian Markison

thank all joining Operator, for and Okay. thank you our you call.

the grow could also business. and you continue leaning close the to thrilled Upneeq our progress with our on have tell as Alora transaction shoulder made are and We in to we've with hard

again. thanks So


Ladies Thank and you this participating. for does today's you. Thank all gentlemen, conclude conference.

You disconnect. may all day. great Have a