Strongbridge Biopharma (SBBP) 31 Jul 192019 Q2 Earnings call transcript

Good day, ladies and gentlemen, and welcome to the Strongbridge Biopharma plc Corporate Update and Second Quarter 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 be given at that time. [Operator Instructions] As a reminder, this conference is being recorded.

I’d now like to introduce one of your hosts for today’s conference, Lindsay Rocco of Elixir Health Public Relations.

begin. may You

good and Thank morning, you, everyone.

pleased today us are could conference join Strongbridge Biopharma’s you for second We call. that quarter earnings XXXX

and Cohen, Chief Strongbridge Matthew Officer; and Wilhoit, Joining morning Chief Medical Commercial Chief Financial Davis, President Officer. Chief Fred from Scott Executive Dr. me Officer; Brian Officer; this Pauls, are

may company to to would in forward-looking statements making from I begin, you risks we be uncertainties to remind results that are will subject cause during the results Before like this differ and that call, actual the uncertainties that the Securities U.S. in event press disclosed forward-looking risks discussed current statements. Reference the detail are release and these to Exchange in the and and with today’s company’s Commission. periodic made in filings and

the over call Pauls. turn Matthew to will I now

thanks us. everyone, Lindsay. you, morning, Good Thank for joining and

overview today’s to will I are Market our the Commercial Global quarter Officer years. XXXX brief commercial activities as nearly Chief by then Wilhoit and promoted Services Strongbridge a of Scott call serving to President the for second providing turn driving recently was that with Vice call, For and three Senior an key results, and of highlights after over summary of to Patient Access Scott begin business. our provide

also Fred will filing. related review development discuss NDA the to LOGICS Dr. Cohen of and endocrine key affairs RECORLEV And then status clinical and our and medical will updates in franchises. rare study neuromuscular the

the our up open Q&A, Davis of financials. we Before overview for provide Brian will call an

the from in refinements in of representing a the franchise, pleased of KEVEYIS believe in detail that we revenue to made contributed this quarter are shortly. report this discuss sales. Scott the With XXXX, XXXX. first to greater quarter in few million regard net net increase in revenue to uptick $X.X rare $X.X for a XX% in for will million field We key neuromuscular our second

top year at adjustments of third projections end revenue guidance revenue guidance, the our believe $XX warranted. could of sales quarter, of Importantly, to revisit revenues upward $XX end we the XXXX will if trends the continue, potential million to our be making we full KEVEYIS our At if consider and million.

positive the the quarter by anticipate margin of a XXXX. continues first to end of contribution the KEVEYIS Additionally, company

performance, priorities KEVEYIS beyond Given our recent for XXXX remain and strategic our in unchanged.

construct investment We will commercial on will organize accelerate disease continue pathway profitability. our to to ultra-rare while and activities market, that focusing the this

also pursuing XXXX. first will We’re in cycle on the have of life these we half that and efforts opportunities, anticipate clarity

Wilhoit. With that, I Scott will to turn over the call

Good you, morning, everyone. Thank Matt.

encouraged with was As with Matt ongoing date, the we have work we disease underserved acquired ultra-rare that ago. are few Strongbridge done before market, short proud which progress this years continued KEVEYIS build made the and we to shared, are we’ve out KEVEYIS of to

positive to want grow focused and that about provide I made then the to on morning, continue we This refinements talk and of some quarter’s performance and investments color making some to the are KEVEYIS. have key

program. to physician-patient we First, services our continue evolve CareConnection

prior physicians in and have We XX program and days communication to content patients their of with who’ve the treating the and enrolled enhanced coordination during and the therapy. first

getting with communication in earlier therapy. the both on is them manage treatment to therapy stay that and physicians believe support of expectations, process We who initiating are turn in helping patients help therapy patients which and on

the or are educational PPP serve. and to PAMs. coupled touch physicians specialists, materials our we of area Strongbridge point largely with An is our with increase our before community and in PAMs environment between effort Patient a this more between helping led transparent improved create Importantly, during by open, Managers, Access collaborative patients treatment, business and

as an in and as other investment offering the to through we and increase the Mentor XX% positive of to is contributing KEVEYIS that our activities seeing trends program, serving Connect, patients actively consisting awareness be a Meanwhile, signs website believe of patients may expand to base KEVEYIS focused channels our unbranded are knowledge we considering are mentors Second, and manage symptoms and patient who our key how market. and ambassador PPP My PPP treatment social with PPP helping PPP live physician option. media Paving to PPPath KEVEYIS and to events, of the the disease. education webinars, the of through

assess findings the process Phase the on results later we’re of to Based work the conducting plan to RECORLEV. from Cushing’s to positive market additional year. opportunity. We syndrome and this in share SONICS of the the study, further Turning initial previously the III U.S. precommercial product reported some

market PPP the over syndrome Cushing’s years learnings that Cushing’s certainly is to with market and applicable of than we Although and more are market, last couple garnered the RECORLEV. structured organized the have KEVEYIS

organization Our commercial in in field This KEVEYIS the endocrine Nordisk XX-person organization established field RECORLEV XX learnings Novo is launch. presence funded potential uptick to – endocrine by at accelerate the with from rare combined the our have space.

built the to has the outstanding, and talent continues is experience feel to can want in resources to the we across we franchises rare-disease commericial KEVEYIS, also that to leveraged across that disease and successfully and rare right market model continue drive I closing, place The organization multiple while for In underscore Strongbridge and effectively be RECORLEV. have markets. preparing refine confident

to the turn Fred. call I’ll that, With over

morning, Good Scott. everyone. you, Thank

at Virginia patients would Chief AAN, In each and the with with efficacy publications Annual quarter. evaluating PPP. presentations KEVEYIS the study Commonwealth On Professor in front, studies. from Associate awareness recent highlight Division and the the analysis long-term Strongbridge-led Medicine a are the to KEVEYIS of May, adult Neuromuscular from at School the hoc of post findings I of or Dr. Neurology HypoPP University Medicine Nick of clinical Academy supporting from most Johnson, examples and like of the presented medical of RECORLEV derived new Meeting, we American of

in patients provides that these As data PPP frequency condition study clinical provide approval results PPP permanent efficacious weakness. reminder, chronic reduction attack treatment. treatment have to chronic supported the is severity is of the muscle after pivotal KEVEYIS. durable and a long-term in The efficacy treatment show that weeks to often HypoPP a KEVEYIS KEVEYIS for of is strong FDA trial It important was evidence and that like durable with durability. and XX a leads to with up initiating

RECORLEV, community the University. Strongbridge- from was Professor research at Regarding Clinical or American via data to Maria continue and educate Phase of efforts sponsored April, Science to & Congress Dr. Oregon AACE, medical by at Medicine recently generated XXXX SONICS the we & Endocrinologists, In Health Fleseriu, Annual progress Neurosurgery completed Clinical the Association of our III study. Scientific presented

clinical symptoms of of acne SONICS, SONICS, and biochemical peripheral Cushing’s demonstrated from described for levoketoconazole results endpoints improvements taking including edema prior These hirsutism, which from which therapy syndrome, in research improvement presentation months. This secondary findings in levoketoconazole. results patients and complement six sustained patients receiving demonstrated among meaningful signs maintenance

we to the the Turning of the withdrawal at end first LOGICS. XXXX, line early in with results the the Consistent our to study reporting of announce of randomized finance enrollment quarter guidance phase to completion of January. anticipate top into patient last

the also and reiterating our guidance of to a Drug of are XXXX. U.S. to the We submit end Food at Application quarter New Administration third Drug the

on would I And update a brief veldoreotide. like finally, provide to

class to reminder, as analog, uses rare established owns veldoreotide, diseases novel in of and common other conditions. a the therapeutics a rights First, a endocrine which global with Strongbridge more wholly somatostatin is

pharmacogenetic an formulation, injectable immediate-release positive to Strongbridge has – comedically formulation. II had the developed using in viable provides patent XXXX. results acromegaly veldoreotide profile, to protection Phase which Due Second, a long-acting

cost-efficient capable XXXX. a results The combination compound experiments forward, development belief non-clinical support in profile positive and veldoreotide Therefore, formulation is the performing somatostatin path clinical of that more immediate-release determine look unique differentiated forward sharing veldoreotide’s benefits. yielding most and of of we our the therapeutic binding to are to receptor we information appropriate potentially

call financial now overview. the that, Davis turn over will a Brian I to With for

Thank Fred. you,

press of $XX.X no Rather today for on our contained with and quarter of Our provide ended XXXX. million and runway. some cash those comments and context my of of through quarter cash financial cash debt. than will Strongbridge second release details, outstanding equivalents all our spend the read details the results

depending purchases will quarterly of the things clinical annual vary customary sometimes expenses, cash significantly, and such in As our for our as is regulatory and timing industry, inventory spend bonuses. on net payments

cash second KEVEYIS inventory. our example, spend the during million purchase $X approximately of the for included For quarter,

included we will expenses in our XXXX by and of In other for will to funding endocrine operations. our occur months semiannually cash field also are timing and be revenues expenses payments the we although and us the net discussed for over as six Therefore, the income years. impacted spend quarterly statements agreement related Novo commercial Novo Those of Nordisk addition, force. our have from previously, reimbursement on to received first the of

quarter approximately will cash be Our $X be million. from and should reflected third reimbursement Nordisk the Novo in

assumptions Nordisk, the quarter operations LOGICS sufficient cash RECORLEV. have payments We guidance fund for anticipated anticipated U.S. each of for are revenues our the to line receipt of submission Novo for first NDA XXXX, along our top a we beyond modest and least at data from RECORLEV KEVEYIS that is projected reiterating timing resources which with and utilizing of through

And, for operator, with that, we ready are questions.

our Annabel Samimy Instructions] [Operator Thank Stifel. question with first you. And comes Please from proceed.

is my Hi nice that uptick. see having guys, And taking a glad for thanks KEVEYIS to question.

on well what metabolic in or want out. commercial you’re and the well to flush Thanks. meaningful anything out other already shown, must a you’ve the must-haves et cetera? very there marketing to of endpoints trial I trial that like have perspective? from in Are from you Just or a that outside LOGICS any regulatory outcomes, flush know you a on LOGICS lot anything – there the reported yourself to from to perspective – now of obviously, perspective like midst as of patient side, the position – RECORLEV, out right as flushing need on Is a specifically that secondary are trying

for Thanks, Matt. is question. the This Annabel

comment data and and done do with job So Fred on nice team this. in analysis the his secondary to generation that on meaningful SONICS relevant very I’ll data clinically I a and data have note want outcomes. Fred related have

beyond else I Fred, don’t that? know add have So, you anything if to

There a LOGICS component titration Yes. which includes withdrawal of – Annabel, reminder, the just is that, I a that the beginning just study randomized period. a would as study. is

you Of it’s secondary period did withdrawal study. if to the what is are period. of because exploratory endpoints course, randomized mean, and fundamentally clear-cut we as different similar measuring Yes. we outcomes we going design, understand an eight-week sort But expect the I a differences, necessarily in be treatment wouldn’t SONICS as

– focused. that’s UFC it’s So mostly

Okay.

endpoints have of need various and of secondary that maybe a the sustain absolutely us you secondary most can from the you read the various me, are meaningful – out, both you perspective help excuse So regulatory to the forward? say just that would you have understand, going commercial and what

reinforcement, see important risk particularly around already I’m the phase sure of the for endpoints randomized previously. outlined So phase, we have maintenance SONICS. in we quite titration that I you we’ll cardiac and markers the think factor withdrawal that

So maybe in things like improvements weight, LDL on the for body example, cholesterol, glucose.

Those we’ve So those that is important on. and main mortality the the of disease. the been are condition morbidity are cardiovascular because ones this the a in ones by lot driven focused

KEVEYIS, on on nice had Okay. out sort Great. already flushes And it any really then of a uptick.

you the is new Or to [indiscernible] new been patient support there. be Is run patients that going say Do in? give bringing consistent compliance? on that understand it could going dynamic feel would a sense maintaining that you forward? these help Just could targeted So that now patients us you’ve treatment? rate patients is that in? coming staying a made, that just So how us you if providing efforts Or it of consistent this is is you’re forward? you’ve it

Thanks, Annabel Yes. for question. that again,

encouraged So are the by from both – perspective. we with are KEVEYIS to seeing regard demand what we and

patients So on therapy. keeping new well patient adds as as

mention run was on this demand well be very think KEVEYIS I those regard Scott the quarter a have as to both retention. With implemented of that tactics they earlier fronts, working. the for seem we strong heard focused on as that again you number we increased of call, saw to rate,

after on quarters, are to consistent We we’ll the a the based well that is say a uptick. see therapy therapy. though we forward, – couple that reevaluate, and the as I we on if to encouraged of of want the currently quarter, of on demand We the coming retention encouraged. very do end obviously, by the – at of third are moving patients results think kind will, as are especially on that there with

you. thank Great,

You’re welcome.

question next with Oppenheimer. Kim our from And you. Justin Thank comes

Your line is open.

morning. taking question. for Good Thanks the

towards what with bit potential so experience MACRILEN. to maybe what launch be? a far, commercializing little Just shift you a the gears that had RECORLEV might footprint on the a team’s is do have sense Based commercial to relative you’ve of

question. for thanks Justin, the

I question if current that the – just with, RECORLEV that can the as question? rare can launch I summarize team intend we both endocrine if paraphrase, organization is our the So well is, to team XX-person current size, that commercial your is as question is in

interactions terms Right. overlap of of sort in And might the that much how be with sort of already? endocrinologists,

Yes.

the size we’re that – of launch that’s front. the for process to potential rare on RECORLEV, So still endocrine team in

I your of and know with with good think we team. and diagnose foundation that we a endocrinologists who have know endocrinologists, XX-person large we to also treat growth adult our do a interaction deficiency syndrome. about percentage question And and diagnose hormone treat Cushing’s did

overlap that RECORLEV. have – we and strategy more clarity obviously, when will more around we’ll for exact not color and I’m on go-to-market clear The our definition have that,

it’s say I safe to high. it’s think

launch nothing relationships with the potential developing – do as and RECORLEV benefit, here but States. of will with we endocrinologists help So the speak to of obviously of in regard United us, Strongbridge, course,

we then which And the III the phase, be last point, readout XQ, data? as of duration at approach great. point weeks enters the LOGICS is patient the X.X enrollment the sort there Phase before point maybe would Okay, randomized which completion in at withdrawal

comment want on you to do Fred, that?

Yes.

be X a line needed nominally that weeks of the period weeks We this weeks point X.X So withdrawal entered time as – as scheduling. that will for the it randomized is last purpose the top visit consistent XX defining withdrawal. you said, randomized patient last patient to we’re to the get The way up from last to the in with for the data. is allow enrolled total anticipate

of experience Okay, switches to which approved could patient considering therapeutic it. maybe patients physicians there by – question we’ve that then such company RECORLEV. been got potential last approval? any hearing a the commercial on like it. clinical And a potential in switching perhaps Got a great from means label just gain Are ahead the potentially ketoconazole from off

for question to that strategy, keto on that for the More off come to thanks Justin, strategy. RECORLEV switch well. potential as future the in label

come to more the So question. on but appreciate do we that,

Okay, great. Thanks, guys.

from from question comes Thank JMP next our Liisa you. And Bayko Securities.

Your line is open.

is guys. for Neil Liisa. This Hi, on

commit see Just for kind a question before guidance thoughts Is – your wanted potentially you you fully another of year? revenues the of just quarter KEVEYIS. on to to increasing

Neil, thanks That’s for the question. correct.

on While front. But are we to therapy, by new on encouraged patient think as demand it’s prudent again, keeping the we and adds and wait increased we are, encouraged. as see that well patients again,

Thanks.

Hong And Thank with our next Scott. question from Janney Montgomery Esther you. comes

Your line open. is

thanks. morning. Hi, Good

So questions. just two

strategy The then… type And discuss first one thinking that KEVEYIS. And pursuing? can you you’re on the of life cycle management of

Esther, I lost think we you.

Francois question our comes And next from Brisebois.

line open. Your is

Thank you.

couple Just a here.

but So I the that with RECORLEV help but can maybe, RECORLEV KEVEYIS Scott, knowledge, clear-cut congrats can launch MACRILEN the knowledge was pretty help just terms wondering, explain just the and help of how with on is the obviously, in promotion, how potential out launch? potential you can

answer let question. that Scott I’ll

question. good Francois, Yes. Sure.

here years. in over And that’s patients not core capabilities products spaces, have and around the fundamental we it’s finding, as disease targeting, have Patient patient who think last launching capabilities I identifying physicians exquisite may rare the in what’s their identification in right? the with really practice. experience commercial that only built KEVEYIS just two-plus

I think on first is velocity patients you the then how do that’s keep And second do acquire you how them rapidly piece. the with piece therapies. and those

model, of it other model, patient-by-patient in. and we’ve bring model we high-touch I is that which think RECORLEV kind specifically is is a which to relates as leverageable may a the built, very products

entire well So for I leveraging being with yes, RECORLEV. fits very, the think model – leveraged very

MACRILEN Novo, far? with you much their the And – about then XX touch in can you. three comment you them? years. for That’s are much terms reps Just so Thank helpful. guess, And have thoughts of I how in Great. on how you very

granularity how to you Just helping MACRILEN understand so far? us much can give the us perspective on help their

in team no is commercial of are to on really we are XX-person Franc, of given the we with our community have our proud Novo. out daily endocrinology the can’t comment and appreciative asset, and fact basis Suffice on MACRILEN we partnership the say our that again behalf that that of a partner. longer it

you I’m that. beyond hopefully, comment can’t – really understand. we So

understand Or to for you for development? Is now? you potential the kind does doing is have of just this No. it. kind be it I then in the me sweet focused remind late-stage for No. Or completely you this on are disease does – in what of already? of just I guys? terms be? can a Just rare spot guys? guys you How M&A, lastly terms guess late-stage commercial of remind spot have to us M&A And it sweet you’re

opportunities. continue Yes. we Well, to BD of basis, an on evaluate ongoing first all,

development strong have and deal flow outreach. We inputs own our from multiple in

really and cycle KEVEYIS the performance RECORLEV driving management to continuing focus potentially of with opportunities and life driving to and it on submitted our NDA profitability is get However, KEVEYIS. the to improve

we have to a now. do organically, So lot

And I of over both franchises time disease highly foundation the But horizontally. mentioned, company stage are a continue to opportunistic also also are and franchise rare leverageable, neuromuscular regard we therapeutically clearly, to disease be of commercial, will and are primary have on vertically in therapeutic rare hearken will the or that as back as strategy aligned multiple and it’s endocrine With focuses. to dependent. and continue areas. dependent to it’s to the asset vertical rare well all rare late other build company opportunistic been is as Scott

it congrats for Thank you and in very Understood. progress. That’s me much.

Thanks, Franc.

Pauls call Q&A over like at the concludes back to you. And to I’d Thank our Matthew remarks. for session. this time, turn this further

our proud performance. quarter we summary, of In second you. Thank are

Paralysis remain preparing and exist. Periodic and applicable commercial for study enrollment that the you Thank for focused to and market, your we call in Through completing support. LOGICS to and community. where submission significant the the address for learnings demonstrate joining RECORLEV. garnering fully are more grow Primary KEVEYIS Cushing’s the is needs the are unmet on making progress syndrome results the NDA We efforts, today’s of for valuable company Our needs the that continued our

Ladies the for and program. conference. gentlemen, today’s concludes in participation thank This your you

disconnect. You Everyone, may now a day. great have