SBBP - Earnings call transcript Q3 2018 | Strongbridge Biopharma plc

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Operator

Good day, ladies and gentlemen, and welcome to the Strongbridge Biopharma plc Corporate Update and Q3 2018 Earnings Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to introduce your host for today's conference, Ms. Lindsay Rocco of Elixir Health Public Relations.

You may begin.

Lindsay Rocco

morning, good and you, everyone. Thank

the that We third discuss which quarter join rights acquire to XXXX financial corporate could announcements, are Novo MACRILEN including highlights. Strongbridge's will under pleased today's Nordisk, Strongbridge's us Novo Canadian and you agreement and and U.S. results Nordisk to with

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

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

is non-GAAP with In to financial generally addition, has conformity call The turn encouraged release. forma U.S. furnished includes principles substitute the presentation now accepted Company's in which GAAP Matthew GAAP a reconciliation information on be and between will included directly Investors in earnings Form this This accounting financial to I the the the are in been investors most the XXXX in Paul. the release, of not financial presented quarter to earnings comparable included are potential reconciliation X-K. figures and non-GAAP over Company's a measures pro the intended for results and presentation review measures. third

Matthew Pauls

and sell and morning, rare day rights for that into to joining Company tiered Strongbridge for has is evolution million MACRILEN growth sales. agreement Nordisk endocrine for and several community. Strongbridge's Lindsay. the advantageous you, Strongbridge for reasons on USD on us thanks to this Canadian U.S. Novo Thank royalties rare this with morning, announced an entered the dedicated Earlier company upfront everyone, transaction payment exciting to plus of continued and diseases. an the Biopharma Good as net a to XXX This

of significantly the First, Strongbridge will will balance in and Novo receive million strengthen sheet which from Canadian upfront for closes, U.S. to December. our rights an which MACRILEN, is after Nordisk the transaction USD expected XXX payment

Additionally, royalties Strongbridge Strongbridge receive mid- receive will through MACRILEN to X, December high XX, X, single of tiered XXXX, MACRILEN. on and from January through the December net on Beginning of royalties also will of royalties double-digit will sales receive XXXX, XXXX, annual XXXX. low through net digit Strongbridge MACRILEN. sales XX, Then, XXXX, on January sales

XX.X a at maximize X over for potential potential deploy the approval share the in a XX% price while Strongbridge In equal agreement. diagnose This and addition, per of to XX in who adult reimburse or gross and purchase This share. XX-person also result condition XX will Novo force which to of treated treat X AGHD. allow of Company us funding of proceeds endocrinologist million. and million million is of shares X.X of to will Nordisk will Strongbridge USD for to for $X by the is fully continuing Novo Nordisk MACRILEN, also USD years million the to that endogenous approximately will the of regulatory hormone and our syndrome, field often a X.X% growth years, represents which rare ordinary Cushing's price approximately to same Strongbridge, MACRILEN the Strongbridge's is closing provide USD yesterday's deficiency, premium RECORLEV team prepare purchase of

the the Medical Dr. would to on paralysis for KEVEYIS commercial our like to our market. turn RECORLEV, Fred Before Officer, in Cohen, discuss Chief discuss over I progress efforts periodic our to clinical primary front I the with call development

We have this organizing disease state. the and structuring for inroads strong paradigms made complex in treatment

our We are the USD Fred more periodic recently third results paralysis. KEVEYIS plans XXXX, With for over of and and XX USD a XX% quarter RECORLEV patients X.X compared slower product I of the to to our We to presented quarter efficacy primary Fred? in we downward patient and Brian achieved increase clinical results. turn forward. financial XXXX USD review diagnosis discuss XXXX awareness increasing quarter growth, will sales safety million to have full focus our Due third year retaining to third the million to of of the on to will USD that guidance that, were million. than in anticipated call X.X million SONICS continuing XXXX. development KEVEYIS moving Then, net XX and adjusted

Dr. Fred Cohen

Matt. everyone. Good you, Thank morning,

Northwest we Matt generated XXth European in Center, the detailed to XX, Wroclaw, Pituitary the during SONICS Surgery in Dr. by results As Congress stated, Maria Phase Association RECORLEV Oregon encouraged the held the University continued Sciences Fleseriu, positive be of in of Annual results and study. for III October presented SONICS Meeting On and Director Medicine Neurological Poland. of pivotal Professor the Neuroendocrine Health

among maintenance August, As to without urinary population, a following increase SONICS endpoints, of study previously its met free primary cortisol, therapy. proceeding that the surrogate clinical or of intent confirmed months to a with outcomes dose announced the predicts XX% endpoint treat X normal UFC, in

the end These RECORLEV. of treatment the several in the Fleseriu improvement with maintenance secondary Additional results months Fleseriu which was in Dr. in that endpoint, predefined to as At SONICS, month UFC new with previously marked normal. participants that important of was, of demonstrated with potential median primary and benefits and Total that analysis at the with of completed key comorbidities care primary also LDL and weight notably on exceeded reduction UFC are a of maintenance estimate payers of RECORLEV the treatment accompanied XX% loss, substantial noted, was independent mortality, when those sensitivity from described a RECORLEV UFC endpoints syndrome X, normalization. of cortisol total represent treatment glycemia from conservative cost associated mean at urinary limit cortisol. risk alike, urinary reductions that markers providers to associated cardiovascular robust reductions that baseline rate normalizers, of Indeed, the meaningful Dr. and who upper of cardiovascular also maintenance are counting the of clinicians, at care. highest for UFC of end UFC. were indicating in affect as baseline, health they in analysis averaged excess the free baseline cholesterol, Cushing's clinically as presented analyses normalization the Xx X XX%, morbidity baseline high UFC least

analysis used Finally, safety that the tolerability of by and Fleseriu's of tolerated presentation details International Results risk of mild keep adrenal further data, for described most acceptable participants liver the Dr. in Review Journal first with injury, SONICS of SONICS, demonstrating drug-related prolongation schemes profile are asymptomatic Peer playing for the insufficiency. from well being XXXX. December a half when and in RECORLEV an and Endocrinology reversible XXXX risks and monitoring for Congress QT has interval publication is and

will the interest to XX development it we program evidence from body trial results Top of in to to our from line for now increase enrollment path Phase study the results. the Type further transaction statistical Brian? in ahead NDA expected to plan quarter I the Brian the is RECORLEV XX review III the filing. best we discuss patients, amend financial its bolster quarter who anticipated the Davies, turn the the we Given our best, meeting, results protocol randomized which increase XXXX. with to the clinical LOGICS increase of study at to over further now LOGICS and C details of from Therefore, forward financial in fourth believe as utility RECORLEV SONICS, expand the of and call FDA Nordisk its patient to are the a discuss clinical the surrounding study. target for power will third confirmatory Novo strong in the will

Brian Davis

Fred. you, Thank

third clinical and research higher MACRILEN, and of XXXX. MACRILEN higher product from of months the offset revenues $X.XX per recorded KEVEYIS recorded associated with to with primarily III basic Company from expense. the shareholders of trials, $XX.X development million attributable interest ended of million share increased attributable compared in a non-GAAP operating to net loss same XXXX, $XX.X The non-GAAP due increase to for in Those and compared of increases or in September revenues were per the to quarter Phase shareholders during non-GAAP KEVEYIS loss net the For commercialization net to the RECORLEV expenses, of expenses, net XXXX. KEVEYIS from million XX, ordinary or net the period $X.XX primarily quarter was The associated third sales. loss share revenues basic and ordinary was million X by $X.X $X.X sales net part

sold portion outstanding was effect of with of million debt for proceeds, to MACRILEN no giving million. the Obviously, questions. there pro $XX.X and And debt cost outstanding cash with of $XX.X after After goods quarter approximately of of of Novo to $X.X closing had sold and course, launch, revenues cash the $XXX that of the today the goods Strongbridge of for of the XXXX. of $X.X quarter. the XXXX effect Company and expected now those recorded of were are period MACRILEN The transaction we revenues announced XXXX. XXXX. And million XX, 'XX from a anticipated cash date. from result a the the forma in cash and period as cost As as $XXX,XXX in equivalents repayment proceeds as compared the same for third that, million Company's September ready in no equivalents of to recorded million net Company September balance, for the of debt giving third during same of July net XX, the operator, separately of Nordisk

Operator

Samimy question Please Annabel first [Operator Our comes from proceed. Instructions] Stifel. with

Annabel Samimy

of going in Hi, my questions. today taking on thanks your for guys. A lot call. things And

question with? you MACRILEN, them KEVEYIS why you? little questions just you came some have tell Nordisk Did now they specifically? it of first And So the that approached I I have guess you a is launched that follow-up MACRILEN us of LOGICS. Can can -- the how on approach there and this you sorry, that just about? Novo I something give agreement. us background Just it given I'm And is timing

Matthew Pauls

question. appreciate Thanks, the Annabel,

in the that rare actually have are unique a and discussions really always in that with to for having Adult hormone be we fact market as an we've company, the we and know, up help because United on opportunity Novo -- important building that part And unique MACRILEN been us. with you fit the fronts leadership, various something has continues BB front. as disease growth to was to construction States. Growth innovative the and this was the partner collaboration unleash around really of came the Deficiency So MACRILEN This up opportunities in Hormone Nordisk mode and around -- potentially here their of open

opportunistic the why right for partnership clearly, we deficiency growth it that It's purely was came adults So us, the that the for right also across. just felt here was thing United now? that an the -- with in hormone States. right something thing patients, And

Annabel Samimy

your different so what you one have be now randomized the Was appears is LOGICS? reasons that? to in a that data program, is it? the Well, funds behind the of it expand Or that flush Okay. SONICS rationale guess have able underpowered to out what for didn't you expanded you needed And, LOGICS? a because I was to the appropriate to why study, funding be with you something It's withdrawal. the that it's there before,

what before? that design would we expect study from that LOGICS you under So gotten the have you shall wouldn't

Matthew Pauls

for Thanks the Yes. question. again

But was let So I'll turn over that, XX number at subjects Cohen. say powered. one, just Dr. upfront, me LOGICS it to adequately

this of the that given potential ensuring funding. SONICS this time. that very the the as was important And Dr. It was the we Cohen? had It do has strength we a do results as to program and to derisk much results, to with LOGICS. However, of nothing it maximize felt very possible. with opportune data everything and

Dr. Fred Cohen

before position this mean, with it looking the It drug -- as view is and It with a it's It's on possibility provides But Yes. confirmatory but strengthening LOGICS you also this increases power can received strengthens It I largely exposure now, derisking a move. move. never high with would a way, increased is -- study. I well. that patients endpoints, that. regulatory echo the as our that have efficacy those secondary other seeing before. too safety the not power as higher of high. it's greater new it's was at

conclude. I'll that, with So

Annabel Samimy

in specific could Is there on I follow If just remains that. the that mark you're LOGICS you? flush anything question SONICS to for in Okay. out up trying that

Dr. Fred Cohen

mark remains No. for us. a question nothing that

so from don't SONICS. all efficacy of our have secondary you know, still Just we analysis

from I strong, it an So that comment labeled can't LOGICS based SONICS what but placebo-controlled. But thus far, that. on it's remember study seen on is we've really open and very was

So they're different in that regard.

Operator

Thank Singh you. Hartaj comes Oppenheimer. proceed. with question from our next And Please

Hartaj Singh

the Hi, going for everybody, but you could lot questions. a And thank stop. on, again,

Novo you're OpEx. just the through applies paying to And want that and them? and is broader then with on One Zentaris. specific questions through end you've I couple is, Aeterna just a go that of to Can know going into to royalties got tiered royalty how So just you then question. make some the some on that royalties Zentaris, the just or royalties payments walk Aeterna a Matt, maybe secondly,

I be is so the that you years. the Now over next will -- at MACRILEN just the got expenditures for X you're Or be question. for paying the out X actually Novo start my follow-up year Is money a years? I should guess, we launch end to And going going taking assumption? to of the

Matthew Pauls

ask I will Davis opine. Hartaj, the to Brian thanks for questions.

Brian Davis

is to So Hartaj, on that question regarding or assigned acquired part Novo. first of what Aeterna gets agreement by the Zentaris royalties

-- are upon the rights So obligations agreement of closing all under transaction. this the that and Novos

not to And putting royalties so impacted are Aeterna the royalties us to another the way. by Zentaris

question, burn the this think of heading On of road the I forward. you're the second where to down our transaction cash moving impact

respects. Novo's They will right. be all -- this in You're product, Novo --

continue will and all Novo. marketing, product by MACRILEN carried et But aspects cetera Novo be the to will force will of promote by field funded be Our other internally.

Hartaj Singh

you. thank Great,

data changes the that meeting prior assume you seems to III it until as the actually and in stronger is dig getting LOGICS stronger. specific going then I that got compelling, So I to do you that to LOGICS question how FDA? you data, the releases had to -- on just a depth the your with you SONICS. once press it wait from of presented, to you've Phase as pretty from the from seems So specifically going mean, and Would Cohen poster just the you be that will disclose the into Type have visibility C you're changes? as you've -- them Dr. think

Dr. Fred Cohen

Yes.

to designed are size. LOGICS actual and size sample designed at really point in So well remaining we of confidence the same. LOGICS a is as just least a at nature of at to very XX. increase only the to is very being of The meaningful study, LOGICS, structure today, study as as take prudent the said, it's be to plan point clear, this the and it's in this those robustly designed, But off sample of from XX we all the have as and endpoints executed.

Hartaj Singh

I Yes. was are a that fear liver table? be And saw the Poland, they values in low that think lab we as Dr. Cohen -- might Wroclaw, on in that higher. the you related that there is presentation surprised are at there

dig as more, data on to been surprising into color that a any this you? that has pleasantly you Just

Dr. Fred Cohen

if always necessary, Yes. elevations, I as job of a did our administering pleased, detecting and Chief test as drug safe and could, was. Medical asymptomatic intervene. this that all, And when I equally one we Officer mean, excellent scheme I'm liver an was any in as first pleased monitoring that well-tolerated I'm

data in I from we'll have very But learn as now. position additional think we SONICS, think, good we'll right I more LOGICS. get going forward, a now exposure and we're

if I'll So necessary. take there, a and yes, let me follow-up, stop

Operator

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

Liisa Bayko

for on. Congratulations A questions couple of and lots going this me. deal, Hi. on certainly

pay the just Do than leverage your for Nordisk understand what a they will Or a just sales to also MACRILEN more. window? RECORLEV? perspective, from your team? to Novo bit still that using force? RECORLEV you to then little force launch happens, KEVEYIS that X-year there with So secondly, And within that the be on patients does full Will structure work? force? force get of sell the on of And product the sales how promoting sales you First plus structural once more their wanted all, other be

Matthew Pauls

thanks Liisa, the of questions. both for

first question. that Strongbridge our members be selling MACRILEN growth the the team sales team, Strongbridge we MACRILEN commercializing Novo employees will and team. XX Yes, Nordisk referred our to hormone Regarding reimbursement with earlier, field and the

So it will a be, from co-promote. that perspective,

Novo the that's time do that RECORLEV launches second So answer the XX focused selling with to Nordisk. question, be a instance, are to that agreement during on an partnership we to I'm We agreement, there sense. period. regard salespeople will RECORLEV? of do to an have squarely, to to opportunity MACRILEN able X. makes able to that your To with that for anticipating course what help question we time be of that. sure. expand would Will launch provide And happens will period during have be team XXX%, lot in we be That that to

So given we that RECORLEV. that, partnership forward, Novo lot around move and the think of a we there's with creative opportunities, come structure as but more to on this such Nordisk,

Liisa Bayko

be And size, many how Novo's will many, the how reps what MACRILEN? be of promoting will

Matthew Pauls

know the But their exact can't of thanks so comment size on team, question. that. don't I for again, I the

Liisa Bayko

And just, a you powered the more that SONICS strong. if could timing trials that. the you it. just, to enrollment if what of give the aspect And could clarify results? complete of you and us expect how sense to just I would was very guess, it, I changes And then, strong then if you've so deliver for as that something pertains add why confused on and then LOGICS, you patients? just, adequately data do But, I'm need understand it I'm and to

Matthew Pauls

Sure.

matter talking here, you risk, largely here, do risk. you sort of if right? think around we if of how it's were business regulatory mitigating a about all So So

we situation do more what have what We make to it it This so do wasn't time not and and in it mitigate say, of reconsidered, we LOGICS sense resolve it take lot decided makes more takes we said, as SONICS our because to the results, makes to regulatory it a a decision may the may And right let's favorable, additional the investment. is the been risk. And into has it the to that here try study putting result we is If sense. that make have good made this money to that. But the better. Study. to

as So as simple that. it's really

Dr. Fred Cohen

risk, regarding technical going you to we when is to sense. opportunity have lot the to it especially Liisa. can, the so a That we're it. do fact decrease strong, to size When as as the It's technical possible, SONICS increase given study that the try sample of much makes risk

so, perspective, of we'll LOGICS end then line by from the a data And tiny from and XXXX. top have

Operator

question Elemer comes next Please our Piros with And from Fitzgerald. Cantor proceed.

Elemer Piros

have or a question a related couple. I KEVEYIS maybe

this quarter guidance, you for versus effort new As discuss your the were you the do could dynamics be think a patient fourth slight the or And bit Could you attrition? anticipate of little quarter. flattish. please you indicated, sales And adds how on a based perhaps? in down increase amplified

Matthew Pauls

Yes. Thanks for question, that Elemer.

of really, organized. is neuromuscular space market one in condition. to be to Paralysis this our the is the committed Primary and a want that's to as and investing leadership not only all, proud really effectively structured ultra-rare genetic This company, I history the very First not be of in of we're that to be state and that to role Periodic

normally in X on Excellence, position's patients that third space. they in been much or is What build at perception is diagnosis worked to have their are Centers second Especially early we rather as market to of that their time, right very PPP, they're perceived local as pull Regional, there Patients disease and increase. that has the right? really for than sometimes generation into, we not organize being severity we although the example, identifying there have very with we're as starting which state, focused later, the life us for instance, this few, to seen case it's dynamics of we're in starting earlier the are now. opinion the prior to that, leaders, of again, are few. are severe very So are

So unfortunately, patients as over PPP older. severity, increases in get time very often

as reduce disease of. therapy on is categories a critically help difficult early patients for So But to paralytic to attacks also getting many know importance we thing it's understand in important. the

cognitive as therapy, what potent KEVEYIS second around realized we from of possibly dissipate period. very start we that that once for they does focused them of KEVEYIS you paralytic are can resourced get we benefit The When clearly and in to instance, can may in see, that about through when general. now to on efficacy to some doing they XX that, perspective as first we much the fogginess see it the that see patients because a XX-day is help tend through on really is patients and attacks are an

help got in the at is line So the Short long-term, really that but And bottom are patients therapy we're the also early get them to organized market some helping staying that this definitely here organizing. But there and hard we've that term, is, through important. on -- were working realize are need, tolerability of there issues. no we are patients working doubt.

So I that helps. hope

Elemer Piros

be you the demonstrating established, lead longer would the strategy both So is keeping continuation you that that -- usage increased a to drug there that going benefit. would in so and would what patients a perhaps to have time on earlier of -- and penetration,

Matthew Pauls

Yes.

drive It So a to KEVEYIS a great and in It the approved utilization. build has only be clear, first this drug the Elemer, space. to continue committed market as we and PPP. to -- are utility is for

well continue patient need over that think help is KEVEYIS. therapeutic I And This of in grow as option patient-focused and build, population is on much patients optimistic that we to like get build business. we'll what therapy, to on to to we'll see that in, as especially continue of stay a and have continue help disease we state are that you're time. year, going us will a it invested this both initiatives We awareness for to

Elemer Piros

fold state a on have gone I further here achievement. a great that that return potential months XX just with may X.X unnoticed made benefits.That's in to you some investment wanted something

Matthew Pauls

Thank you that, for Elemer. noting that. We do appreciate

Operator

showing no remarks. questions turn Pauls At you. in further Matthew to this time, the call back over for I'd queue. further Thank like to I'm

Matthew Pauls

again, call the for you, morning. everyone, attending Thank this

stated call, Novo transactions I on rare and the disease We The Biopharma. Nordisk and with to to Strongbridge's for support. look today's As earlier is strengthens your balance for day serving Company Strongbridge while call today growth continued our forward for the of the the exciting joining needs incredibly success. continued an sheet continuing positions build business, from community. Thank you and

Operator

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

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

Strongbridge Biopharma (SBBP) 2 Nov 182018 Q3 Earnings call transcript