OSMT - Earnings call transcript Q2 2019

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Operator

Good day, ladies and gentlemen, and welcome to the Osmotica Q2 2019 Earnings Conference 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]

I would now like to introduce your host for today’s conference call, Ms. of Relations Investor Wilson, Osmotica. Lisa

You may begin.

Lisa Wilson

Osmotica’s operator. business update you, for Officer, With call JD Welcome Chief Chief Brian Wilson, Einhorn. to XXXX quarter Osmotica. are today’s on Officer, second Schaub; Pharmaceuticals me Executive call. Operating Relations Officer, Markison; Osmotica Investor Thank Chief Financial This Andrew and Lisa is

a call XX, detailing the three for be afternoon, company XXXX. press the of This This results Investor the this issued at the financial a webcast release through accessed Osmotica and ended can osmotica.com. press June of release section months website

Before and we conference Litigation that call would Company’s be may the intent projection, statements to today’s any a express remind or belief, expectation, future defined Securities performance get everyone Private started, forward-looking by I the that forecast, Reform considered on events statements as future made Act. anticipation like regarding

statements, These including guarantees or in to differ any afternoon’s available forward-looking be from on disclaims of the website, statements. update days on law. performance. our intent archived required involve as based filings not as our forward-looking and risks may osmotica.com. SEC. results available Actual noted future management Osmotica Osmotica’s with this materially Such these those specifically forward-looking the call statements information will to by projected those forward-looking The except statements of release and obligation are are webcast and of in for uncertainties, today press XX this

may releases XXXX. so the may held Osmotica have filings. recorded to most or please webcast, was archived those SEC then, and announcements discussed, of recent replay Company’s topics related who X, this August benefit be press reference listening made the the and to the For on call Since

And with call Brian the turn to Markison. over that, CEO, Osmotica’s I’ll

Brian Markison

you strategy thank call. I’m and the specialty transform for to its to to to advance report pharmaceutical Osmotica company. that joining continues afternoon, a pleased Good

month has The for potential to NDA this RVL-XXXX, track of of on commonly eye. global for assessment the prospective submit its treatment more our we foremost, ptosis, begins company and product completed to outreach partners month. droopy First in earnest breakthrough next and the the are as known

Furthermore, realign to outreach expense introduction base key KOLs, life. early scientific presence as commercial The as possibly prepare to XXXX. to for we’ve QX our this the will take publications meetings operating come story begun company’s at begin and

We future will acceptance already which of to live publications at topic be of received notifications various and releases. presentations medical upcoming the have meetings,

for will ptosis not has for potential improve meaningful a RVL-XXXX option who that be vision believe the those but to have and surgery. We field are peripheral of candidates appropriate

to the filing Second, is programs our continue I arbaclofen the company in am The with to FDA pleased dialogue NDA. advance. neuroscience to report that discuss

baclofen ratio believe our While optimistic we time, assurances has we remain when at can and the this to molecule, a parent that meaningful compared risk-benefit no make baclofen.

And products third, to dosage the generic for as remains business solid and generic perform The challenging. market Company’s oral continue branded expected.

our derive to from meaningful assets continue transformation. fund we help to However, these cash

and he Operating Andy? like further Company’s to call by will be Company’s in will the results, discuss promoted will company’s who the over I’d detail. Einhorn, Now Chief discuss the financial followed who turn the Schaub, JD products Andy to Officer,

Andrew Einhorn

months the XX, sales three the ended June Total for decreased months XXXX. three three $XX.X $XX.X million three million for Brian. million the months months to product XX, June as June ended compared to June were you, to million for Thank by revenues $XX.X the $XX.X million ended ended XXXX. compared XX, $XX for XX, XXXX, XXXX, Net

strength competitors quarter decreased entering lower prices. dosage launch to X% Net of sales realized product and decreased during the by quarter in net lower selling offset net sales the additional due XX% lower-than-estimated during resulting due following volume sales prices returns. including which market methylphenidate selling competing partially to second of in ER, reflecting launched the M-XX, quarter significantly net Venlafaxine XXXX, largest the the a was of higher product

expect these as in generic and will future additional impact the and the as from competition future, and if competitors We XXXX both product our of approvals for these venlafaxine well to methylphenidate the of ER any, remainder sales years. products continue during negatively launches additional in

quarter increase to million costs million associated associated Selling, force during expenses general with a company. in headcount sales to of as and Osmolex $XX.X with being and launch the together compensation expense administrative XXXX The with to share and second costs increased higher of ER compared reflects $X.X additions the million $XX.X quarter marketing the of second XXXX. public

compensation development million and in Research and expense. as X trials $X.X completion $X.X This quarter. during quarter to both the of by decreased million the our first second million Phase compared clinical and by ER the $X.X the offset share RVL-XX.X expenses year respectively, for of reflects partially arbaclofen XXXX, during prior to quarters

charges During for second million intangible recognized, which weight was XXXX $XXX.X of $X.X value of quarter impairment included quarter to of million the million core by Osmolex of second and Net of income book of of in of were the ER the $XXX.X XXX,XXX. $XX.X a asset write-off XXXX. million venlafaxine million and quarter, the $XXX.X compared net reduced a loss

quarter was EBITDA the second of the of XXXX million compared for adjusted second XXXX. EBITDA $XX.X to of million Adjusted in $XX.X quarter

a income EBITDA end adjusted of loss, net the or at please see the press our to For release. reconciliation of tables

its of capacity million facility. of XX, June cash and $XX XXXX, of had financing cash revolving company net debt, of costs. deferred Osmotica $XXX.X credit had $XX.X of million The also equivalents unused and under As million

I to the Now JD. over turn call like would to

JD Schaub

brands year. and solid recognizing the launch off we In smaller recent launch since see Divigel, base of M-XX Osmolex promotion our growth and XX% January QX, quarter, of respectively, growing most than TRX from promoted only prescription with continue a up is second to our Osmolex, XX%, Andy. began XXX%, key versus Thanks, greater in this

we volume back the XXXX. the half growth through continued and sequential first strong move half momentum through year the of the by encouraged are of We as expect

from channel patient scale, marketing national strategies, Importantly, commercial the future serves programs stronger key networks, and that to growth establish begin the the allows pipeline. commercial infrastructures brands business. field programs, also pharmacy for force supporting capabilities a existing framework these all Larger we earnest. drive leverage our with investments existing will as to also for RVL-XXXX us It continued preparations represent access our growth further in

launch the Access its in for with environment a first specifically, momentum quarter care compared enrolled program XXX total or health challenges, ER in the XXX XXX wrote its patient XXX today’s new health Osmolex by are March comes prescriptions unique at at in of continues but June, Through gain set More of receptivity. overall providers XXXX. full market. via of promotion, providers calendar to the product encouraged end Every of to and least care one Osmolex we prescriptions

continues our requisite validated Importantly, payer claims payer further by rates, clinicians coverage clinical are success, refill who early have increase X seen patient approved XX out while adopters criteria. of and to strong with ultimately are

as Our continue this trial the forward. key limited, sales expansion from move and insights learnings, support audiences our effort of focused to to in we and growing behind latter And the will which of part promotional utilization awareness we expect Osmolex the year. provided in growth has yet and footprint accelerate target our field

pressures to through grew QX. as ADHD QX, we Despite to through on over M-XX, market overall we XX% moved continue regard see growth total prescriptions steady the With demand seasonal second quarter.

configuration we use encourage M-XX convenient HCPs to more also XX-count as This retail partners product. for from a bottle trial voucher as for quarter, an transitioned of unit our CX introduced program allow pharmacy a well with to to this

current our pipeline. from our To the growth wrap late-stage while further resources organization to and remains transformative opportunities and up, focused the from prepare execution support ultimately brands, maximize on beginning to our and align potential

turn would for to back closing call the like to Brian I Now remarks.

Brian Markison

thank market the to time to we for Thanks, afternoon. this you future. and in look And on JD, the our continuing update near your forward progress

turn over With field to the like that we the that, operator call any questions happy to would for to be today. I’d

Operator

Randall [Operator comes from first Capital. with Instructions] RBC Stanicky Our question

Dan Busby

on still Busby, the with And you FDA need here? the consider share can commercial you just Few is launching of out-licensing have us from be pre-NDA This so, former, remind the for your this yet? would that you guys. you infrastructure able to to it leverage choose your And can extent if commercial meeting product U.S.? committed existing any where to will Hey, resources? you three, you’ll to if your Randall. for regarding Two, start. on you strategy, versus One, Or held Dan in yourselves that? which to questions lunch add feedback RVL you are

Brian Markison

was Great. that troublesome. and unremarkable I the Nothing out with of meeting did quite it really pull can Yes, have pre-NDA it that unusual positive. was we and a agency

we’ll approval. and we So filing first-pass month, anticipate a next be

agreement and, agency. off-line. again, approach it it our with all on But you the fronts a We’re was to very in through confident complete happy more take

partner, to that and our now, With in respect next consistent we earnest to plan We’ve outside we’re the partner it launching with it We ourselves. ourselves really seeking launch capability week. a right to seek believe pretty going is have the the story, outreach been of U.S. begin a and to

get is have may very and you on to somebody listen it. that. not fools have together We compelling proposition, JD, the a wanted would resources, and add value to to like be if we’d to extraordinarily to but interested

JD Schaub

U.S. we I and loop, time, part question I potential I was there it like is Yes. we from additional. I to what for last JD. is But in in terms close at to Dan, existing is and the I footprint your launching to of where the back a this, out of to our our with this I when think think XX,XXX standpoint, the we ourselves over expect. we as a versus And of time? the infrastructure infrastructure existing look targets it the And just think go serving off has at of the be majority perspective. of the class, the exactly to successfully. XX,XXX medical ground what think, very from this over in potential the to ophthalmology continue first get the be need When root absolutely. we competition add existing Will reps would think optometry field no comfortable foundation that’s product

Dan Busby

And arbaclofen. That’s just then on helpful. Great. a couple

First, that to can based able opportunity, second, clinical know feedback just market? arbaclofen what’s with today, what with you you’re expectations, Osmolex thinking quite is ER have another that launch interactions meeting respect Thank you you’ll And And your bring your likelihood influence trial? assuming to around any on to this not share product early to run FDA? the the from you.

Brian Markison

that to back that prefer having anticipate not the has to question and bit The we’ll we to elaborate been But We would And you absolutely and is get right package is you agency data another We interaction with we this there set do dead forward not. last a feel do the have fairly to, the but further further. very until to you now we’re answer the and look little procedural. confident we that come file, on But never NDA. The truly with not discussing know study. it comprehensive. – are we FDA. resubmitting

Osmolex. to back So

another it’s major mind growth that important and sure to space drug that and only our launched size but launched the short And neuroscience that make and be with to disorder a the into and opportunity foray not a correctly, think proposition really in company, correct, presence. of we XX scoping we to for marketing wanted did I admit we the drug our keep ago while we we that going were we this before market we readily movement the to was representatives. extension our had

data Arbaclofen opportunity outsized an we compared at when and certainly Osmolex. to that is it have the looking

we two. compare So think the I can really don’t

and presence I think can for disorder the specialists. the movement learnings we the with leverage Osmolex

So anything – you you’d to add any color JD, that that?

JD Schaub

No.

with I really the opportunities But captured clinical to an building Osmolex. and again, in having perspective, of everything, associated with and arbaclofen even arbaclofen. two data product Brian terms They’re Dan. presence out launch of from a leverage bigger different commercial a program versus think given opportunity

Dan Busby

arbaclofen? And you plan just FDA one anymore Okay, last Do meet submit with question. your you NDA great. before to for clarifying Understood.

Brian Markison

Yes.

sure. For

as out that we working speak. We’re

Dan Busby

cool. Thank Okay, you.

Brian Markison

Thanks. Right.

Operator

any further turn like for this to showing not call remarks. back the I’d Brian I’m final question And time. at to

Brian Markison

everybody. us joining Okay, today. Thank for you

will which We’re month. excited day. our tuned and Thank about prospects NDA filing, you, and for next stay the happen good RVL

Operator

Ladies this conclude presentation. and does gentleman, today’s

day. have now disconnect. a And wonderful may You

RVL Pharmaceuticals (RVLPQ) 10 Aug 192019 Q2 Earnings call transcript