SBBP - Earnings call transcript Q1 2019 | Strongbridge Biopharma plc

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Operator

Good day, ladies and gentlemen, and welcome to Strongbridge Biopharma's First 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 follow at that time [Operator Instructions].

As a reminder, this conference call is being recorded. I would now like to introduce your host for today's conference, Lindsay Rocco of Elixir Health Public Relations. Lindsay?

Lindsay Rocco

morning, good and you, everyone. Thank

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

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

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

Matthew Pauls

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

providing quarter the results. summary I'll ongoing call, brief Brian of development a Phase today's to X over the call will first our to I Recorlev provide overview. Fred clinical financial Dr. begin discuss For Davis and for Cohen the and highlights then by program XXXX to turn

call with with C Recorlev. We X our first Type regulatory path of up I'd to open Cushing's In the for start endogenous the a syndrome. potential off forward for FDA XXXX, held meeting questions. the development quarter will clinical discuss to asset an then like Recorlev, on Phase we update for lead the in the treatment of

both would in given submission an may studies. LOGICS expectation with went the As incorporating our agency the Phase and NDA recall, said, X the meeting recommend SONICS That we you data discuss unmet sole from the into SONICS the fact well SONICS the with as with wanted positive need FDA pivotal also to trial significant trial. as the Cushing's possibility the submitting syndrome, results of we in the as that from

NDA LOGICS double inclusive submit of the thereby, meeting, controlled more with SONICS placebo the and LOGICS, randomized agency a data as providing contributing C recommended both blind expected, package Type from an we data. During clinical robust

deployed we delivered are net year by rare launch of the $X and revenue to neuromuscular the in million. first that to Strongbridge, experience revenue full heeding for additional revisited FDA's the quarter are XXXX in the million months our as States million be among NDA we specifically, team's million to our as Cushing's valuable Nordisk can we the Recorlev Onto quarter the six endocrine pleased we We for The in $X.X of treatment for have approximately per and provided, XXXX, to $XX submission syndrome. with space Keveyis Novo provide the rare on of submissions believe that Keveyis our now comprehensive by our to United $X We than final approximately report we years. clarity anticipate of XX-person timelines submit organization, currently on Recorlev. most presence third earlier three NDA being comment in toward endocrinology end approval and rare the and field previously approximately and we advice initial we and this for subsidized million the $XX next potential are track is the achieve will gaining are they a franchise, the a A should in rare endocrine a at reminder, the field commercial year franchise guidance anticipated. work benefit

we quarter to the year on the Dr. of our Fred over noted are on call turn call, positive a as we XXXX track that, so. Cohen. to the Finally, I'll achieving on are and With of end Keveyis by contribution do end first focused margin

Dr. Fred Cohen

everyone. morning, Good Matt. you, Thank

the from first of patients the the presented syndrome. three treatment of During quarter, the of utility, the that in clinical summary with following results analyses Strongbridge helped Cushing's profile and number broad Recorlev benefits to characterize safety SONICS endogenous new potential conclusions. study Those a included

additional no and SONICS the the portion in or other relevant signals durable meaningful. there evaluation extended clinically liver-related First, safety efficacy clinically and were of remained

Second, SONICS that diabetes. markers subgroup Cushing's in in was showed diabetes, with effective and analysis well-tolerated and urinary significantly both free reducing syndrome in reducing Recorlev of patients cortisol

edema data Recorlev Third, journal improvements additional and significant the key remains syndrome manuscript key Recorlev analyses hirsutism secondary a analyses of depression. LOGICS. and and will to as led as of for now improvements symptoms of life Cushing's brief update and in showing also signs on free-testosterone quality I in the peripheral XXXX. phase maintenance show in as acne, of detailing well such of that of efficacy SONICS quarter from to provide the track women. the end Submission review a safety of peer second reduced

statistically was well. progressing the you The expanded study significant from chance XX As best is the provide LOGICS recall, demonstrating study previously may patients to efficacy. of to XX

than receipt enrollment, slower now XXXX. believe supports of to due guidance Therefore, submitting NDA quarter an are of is this top anticipated the we our end updating the which at XXXX, to third that the in before data quarter risk. However, of line year we of first

periodic term following for a to With with the presenting to call of hypokalemic Annual reductions was Turning at long HypoPP hyper data efficacy study The Brian patients will the from paralysis. the Keveyis, of our over that financial Davis neuromuscular frequency in begins download attack Keveyis in Meeting provided I this efficacious and severity be data Neurology, as presentation. look turn treatment rare Academy franchise long-term to website available we that, American and now to paralysis overview. demonstrate week. with The and known which poster XXst primary later from the will the and forward periodic durable our immediately

Brian Davis

Thank you, Fred.

spend first cash and contain our my our all release runway. than comments XXXX. some of context those of Our of results financial through the details Rather provide read press for quarter on details, will

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

related be will by our arrears. of Novo cash will quarter the commercial on to to Novo revenues other quarterly of and are that operations. also no Please payments, cash In us, in of we cash expenses and $XXX.X equivalents occur in note endocrine agreement outstanding funding timing net statements Nordisk expenses Those our from the million impacted addition, for and the included and Strongbridge in semi-annually field receive ended Nordisk and force. debt. income with our spend the case, reimbursement

at fund guidance for operator, cash of our sufficient through we We along Keveyis our with first quarter And, least that, the we Operator? questions. have operations are are resources, anticipated with XXXX. reiterating revenues that to ready

Operator

Annabel [Operator Instructions]. Samimy comes Stifel. you from line of the question first Thank of And our

Annabel Samimy

I are since keep to possibly the that and secondly, patient I the needed requirements education Keveyis patients Recorlev? C the condition given you that to came of was us with requirement of long terms the around sense Can the any patient urgency the patients out to some what regard number of characterize back? compliant? you us brought wondering as retention you the on could then, for little Thanks. just a safety Type lay you've there the just up issues Any support FDA -- specific ICH Was meeting more sort of in bit. guess, patients? implemented, guidelines, term they on give the of if assistance Did of also Keveyis. And of safety a of that other a have

Matthew Pauls

implemented say to will Cohen are it really currently are the those answer the patient including, year, Let helping taking then last Recorlev. and patients over who this at regarding new now process. who Keveyis to me tactics Dr. to we now I in I of have right during Keveyis take half will and that the engaged is turn Keveyis With point regard question are patients are the second all first question the to that Keveyis, ambassadors, we they

We have and as and engagement again early patients efforts in CareConnections. patient the case our managers with to management as related their process our caregivers well increased our access

what over on we a is, will a trend Keveyis have just implemented patients staying are and to seeing those key the therapy. are tactics positive few to related say of converting that and I So we

come in to say those positive our with is, it but focused we're to effort year in more suffice the that seeing more areas, So details potentially regard to trends. later Fred?

Dr. Fred Cohen

So with information safety what and LOGICS that fact term most so from and the Type particular Type data encounter long and package, SONICS the be that both among NDA regard initial valuable to this see package condition. to NDA the making we've agency in we included the an meeting, clarity will regarding make was related this up it gained Recorlev, comprehensive at the in discussed packages to looking the C C and the

not from was included at over to total safety we've prior long on question. exposure, for term we information the long to that the this substantial the we will Based were is package safety package that guidance SONICS believe the NDA everyone at exposed and term trial among year. which least that a of remind received based information terms that patients reported the for number, and division, sufficient product provide that from call, and study the that, the that LOGICS In on I'll last XX the

Annabel Samimy

anything And that be I to Macrilen going in related revenues non-operating lines… correctly are did expenses just to or hear income

Dr. Fred Cohen

Yes.

Annabel Samimy

royalty as the that includes So well?

Dr. Fred Cohen

that top line, but be be funding No, on other the will the royalty force, line. income to is revenue the the going field in of the

So non-operating in it filing you'll expense be will will with as see also that non-operating expense. be our XX-Q the And and associated that well… income

Annabel Samimy

on whether quite I Novo royalty you that is going prioritized in that though, bit. have a this to as then do de-prioritized Macrilen, vein, down Nordisk with think any And what's has sense program? or

Brian Davis

really first you in I quarter at of beginning as and obviously may the the transition. right quarter transaction December we recall before looked No, the think, just the of being closed one as

it standpoint. wasn't So our from unexpected was royalty, say, I'll the nominal. somewhat It

and is year force near year have as More per a over already revenue very out field significant relative along us three XX-person importantly, million in funded. our force of $X significant we million there. that's Strategically that to have the being field is But to a the to for Recorlev stream us bring term $X hope value that we period.

Operator

you. Thank

comes Kim from of Our Oppenheimer. next question the from line Justin

Justin Kim

came of SONICS which diagnosis patients years, exposure study to proportion that of these the I'm approximately a was of the was had considering and patients median a patients time correct each for data, drug at into mandated outside sense if naive pharmacotherapy at Looking about there period wash-out with a third? historical treatment three

Matthew Pauls

So we around haven't yet. medicines historical details provided

received data I a of think manuscript patients therapy relatively proportion other Suffice releases. to smaller syndrome. be medicinal in some had of it presented and that for the will prior say upcoming that Cushing's

is average, the on population to think severely on matter to very patients relatively calls, diagnosis, I new the said a affected, diagnosed what affected you median years, and as younger severely population other out relatively Cushing's I was by relatively as the their who but there moderately think, time while I So were of recently number within pointed a were diagnose to three around so syndrome weeks. of substantial

even XX% of population any at therapy, the never received had baseline And yet. so not surgery

So, of off on other medicines, it's we syndrome very clinical information, an experienced broad in gather regard patients in unique I what experienced the valuable that naive somewhat syndrome. on treatment Cushing's the obtained but population. and we that is a realm now in therapy population washed Cushing's patients, only completely had patients which interesting trials from can not Plus are

some and it drug gave experience. a broad valuable very So, exposure us overall, very, the very with

Justin Kim

point, proportion would participate this SONICS sense you patient at population study then, LOGICS? have And the in what do of of a

Matthew Pauls

that study when one point up from size all going to the thing the that get were in of we took SONICS XX, that note XX that, knew is at patients enrolling. to we already sample in. But is So, we're to still the there

LOGICS study. XX the all So a the the naive. will to naive coming the from fact SONICS treatment meaningful of in And will be majority those minority in drug completely with additional be patients

Justin Kim

following there maybe is term might very when And just the from taken Recorlev with experience that periods if hosted dose then and of study long Cushing's a clinical often that one And extension this maybe in analogous commentary are titration the there's for to practice treatment that last tolerability the approach? Keveyis. for anything type KOL, affluent could indicate Recorlev periods provided recently one. have you that something observing We improved

Matthew Pauls

that was much, evaluation I showing the new or after phase in extended the that been the in incidence mean, phase recently were data events the of for the of we events lower maintenance from six already six portion had of maintenance. months SONICS second worsening or shared months much subjects

going upset, size, are to for product, tolerability And tend related is that that if a so mild and you in GI the The like is liver same develop example. occur increase function for that's going to indicates early. to the an what of to adverse event issues true example,

is, seeing being and labeling. of levels high milligrams other that again when and time the events called in expect weeks. go, the and a the two are common conducted adverse early. high XXX XXX there's cortisol SONICS the withdrawal ascribed every The ostensibly how Overall, start our events we're thing pretty how are That's to subject. kind point And milligrams were of events out of cortisol PID, low adverse that at occurs with the on a are study we cortisol slow exactly out we that's kind that rich reported that syndrome long literature way it's in see to in The is been study. titrate studies withdrawal lot adverse a you that for lowering to

Operator

the of Our next Liisa Bayko JMP question comes from line Securities. from

Jon Wolleben

Jon Thanks is taking the questions. Lisa. This for for on

Just to a for for net Keveyis. the for was you're on quick gross what quarter what bookkeeping year. I and expecting this was one wondering Brian

Brian Davis

as haven't particularly it in these given that talked to first on And that gross insurance. the elevated was in but case you is the net, folks Jon, we it first the So, following say will typically commercial on from the resets I companies likely with on quarter know specifics quarter.

percentage the the demand front. we reporting to last subsequent looks talked was to -- we So expect a revenue front, first we I some of go on good. bit so on looking that it say net out gross question year. quarters it will about earlier an year. the Matt little and earlier as the the tactics was to as the quarter elevated that forward improve on in are to it in And through of

Jon Wolleben

enrollment implementing you confident you initiatives current you LOGICS, time how regarding with Thanks. your currently to many or and you then any can tell speed enrolled patients And have are guidance? and are

Matthew Pauls

at beginning of line with the So by we've off of the guidance. just We're pushed being risk we're of confident in the year to end this guidance. in in the quarter. next top first share that results, the it current timing able so We're to confident terms year

with working, tactics great we're guidance. are Our so confident making that progress yeah, and, we're

Jon Wolleben

patients many can today? enrolled you And have as how of say you

Matthew Pauls

this the guidance point. So on we haven't been giving enrollment number at

So update on have we that. any don't

Operator

line of Francois Our from Brisebois next the question comes Laidlaw. from

Francois Brisebois

were try Just ever understand way couple there versus are terms of of here getting a on provide or the necessarily in weren't is understand to patients Keveyis, here because issues, how out? right that metrics how to going any dose -- on the see growth help better and us staying kind on, just are to on guys many of that ones to out any help us the to staying you

Matthew Pauls

can by shared. goes quarter think be each indicators and you there potentially we that more performance space expect as the paralysis think I I periodic Keveyis, and time primary key will metrics, more learn So about over

lifecycle we said, what's that here of year. $XX $XX think guidance XXXX. that in front on more our of neuromuscular of franchise management opportunities related the Keveyis or by to year looking to the that important really publicly said we affirming And are I obviously to are have beginning we we the hopefully our this million million come have end rare is and that

in this KPIs. hopeful affirming of the again, revenue $XX related some we'll guidance be sharing well $XX details we to additional to million million as that are some So, year, potential

Francois Brisebois

you enrolled. seems it has a what have on the just it -- it reasoning the LOGICS little is a was timeline number increasing remind like is caused original on the you just that the But be of slower? that some and to enrollment Can And us what then guidance incentives, then ambitious? for it any giving little surprising not or Is you're the enrollment. maybe

Matthew Pauls

we the I again, risk. think think that is the data to LOGICS guidance because at important by the to that from it's note timing So year top making of our we're end line adjustments

quarter third spirit XXXX our than then happens just another clinical of into you'll prudency the thing months tell case, we is So, bolus. to year. shift quarters next first what forward base and NDA then or Fred two it'll slightly lumpy quarter it's here approximately of right the factor is, you, the These our due of we've get will it and which little whatever and fact that and bolus a feel a be of submission trials, previous pulled do they're you'll to get in earlier the the to to like slow patients effectively six

responsible we you being into thing first in is to prudent, the quarter. shift the comments? just So, the guidance additional again, have spirit do feel other that of the Fred, do to any

Dr. Fred Cohen

really. not No,

working. Our tactics are

We you are normal a And of situation with seeing participation. the sort think can't of right. XXX% Matt predict lumpiness It's of and just more is and accuracy. enthusiastic I variability always

Matthew Pauls

it And Frank, XX XX actually positive SONICS. Clearly, SONICS, parallel and the choice of had part was trial Fred comments but to going second the a this, if way initiated based question, to part of I'll on to made other looked opine risk was, you on original the of out was need have we that at subjects in I we there? can. we we take much results from of that powering the a ensure your may, Phase Fred, as any And it LOGICS. in we as while appropriate, X

Dr. Fred Cohen

use coming What maintenance in assumptions. studies no -- treatment our that We other active in we on time controlled group, then SONICS response we group. were the the did and space of have At randomized-withdrawal this staying from end spontaneously, built the with had of to who the on benchmark of as placebo as data of terms into SONICS. happens of we initiated well placebo with LOGICS, the the some patients in patients drug eight drug weeks off as a experience

the going They basically It's So, a NDA positive and a why bit. just risk we any that LOGICS sample SONICS efficacy basically our conservative. took study, also be positioned LOGICS were a effective or really when for of And, have hit. we and assumptions want are part conservative now you have power our to to it's take as LOGICS Matt demonstrate up safety, with excess importantly size. you risk the said, filing. believe key We to

Matthew Pauls

that it's piece to And up data are already from that with of at in Obviously, first design but really construction now the sample I'll quarter we increased of are wrap the we development. think the and the us well we confident NDA LOGICS itself the of as that as the work associated the There year. results that place. risk next just LOGICS on expect with, is we with always that, feverishly starting in size see drug of are we we course good a and that and want need will have put trial

Operator

from comes question line of Janney. next the Esther of Our Hong

Esther Hong

the years viewing expect How occurs And still for three launch is to and endocrinologists Novo promote included can in then, of place if given U.S. how after using second, commercial we first, sales XXXX? Thanks. Macrilen, agreement of a about launch are Macrilen? Strongbridge's with the force proceeding? team reimbursement Macrilen Recorlev to So infrastructure be

Matthew Pauls

first question, all, for So Esther. thanks of the

endocrine kind us fluidity XXXX. and Just up our in of very launching fits regard really way is XX-person in shaping the with Filing nicely. third the to to very, timing, is, commercial field-based team. regard shaping of regard has up with with And actually nicely continuity timing it's rare potentially XXXX quarter this the to

then So so of a our get hope sense. anymore, Macrilen. of to I commenting that really related the benefit on the not asset the from kind was that perspective. makes question maximum second not actually we're It's part it. of on number And we fronts

make that away. no that out XX-person the longer in Our working we the partnership fact the given really asset. own is rare And comment force every Novo with endocrine field day we they and only that's can are

Esther Hong

will Novo XX still force plans sales retain that are Macrilen? of members for And the

Matthew Pauls

No.

the XXXX, for XXXX deal So XXXX. structure the and of is

basis are space, they endocrine of on but And these Macrilen Novo so in remain are employees, rare employees. three at our on employees. employees, Strongbridge they working deal, the with XX a end year our are Our the daily that

sense, retainment no there's et of there's cetera. over make that crossover no So to component, Novo, Esther? Does employees our

Operator

I'm closing further Strongbridge over I'd to turn Mr. showing Pauls Biopharma's and like no Pauls? for call CEO, time at this now questions Matthew remarks. to the

Matthew Pauls

new advancing regulatory X encouraged Thank insights and Phase summary, program development and very with you. with Thank look understanding devastating option as the to We from the are clinical awareness call FDA into healthcare are support. In of on the treatment quickly and by important are rare discussions Cushing's syndrome forward the your we had today's providing to as Cushing's and for generating to-date to patients providing data syndrome we've are and professionals disease. we raise joining for of a Recorlev. working you use this The for of possible. submission this Recorlev focused the and difficult program potential continued

Operator

call. Ladies and conclude does conference. you in the This for gentlemen, participating today's thank

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

Strongbridge Biopharma (SBBP) 1 May 192019 Q1 Earnings call transcript