CNCE - Earnings call transcript Q3 2017 | Concert Pharmaceuticals Inc

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Operator

Good day, ladies and gentlemen, and welcome to the Concert Pharmaceuticals' Third Quarter 2017 Financial Results 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 call may be recorded. I would like to introduce your host for today’s conference Mr.

Koenigsberg. Justine begin. may you Ma’am

Justine Koenigsberg

you. Good quarter Concert third welcome morning, investor update. and XXXX to Pharmaceuticals’ Thank

Our announcing our morning concertpharma.com. and also press earlier on an issued release available electronic our financial copy website of our press is was releases at results this

addition, we launched handle third our us at quarter, now you can follow the @ConcertPharma. during twitter In officially and

open Chief Cassella, Joining the joined remarks, CEO; and and Tung, our me President prepared where questions this morning to Development by our Stuart, call with Operating our we prepared we be After remarks will our are Roger also Officer. Officer. Nancy will Chief Jim

to today’s actual today’s made call I As to those from A statements as most like remainder, the future we subject over assume differ filed expectations, description forward-looking speak our XX-Q to and projected. risks can of would recent discussion a to cause statements obligation only in are any about uncertainties the SEC. statements our be With results will include date turn and that, found to materially and These today’s forward-looking call. update prospects. Any forward-looking risks of these now with plans, may Roger. no on that statements

Roger Tung

Thank you, Justine.

importantly meeting from accomplishments at value us the committee to of position focused PhaseXa, During with important quarter resuming and purchase pipeline. milestones. closing last strongly - agreement our These patient X the a enrollment Phase the achievements development drug alopecia in number quarter, Vertex. engaging announced the the asset with developments third trial clinical include we areata of and These FDA business the CTP-XXX create

program disease. The FDA’s this for therapeutic disease drew patient, with Alopecia treatment an serious in Phase patients by impressive and significant onsite areata further to we oral areata the meeting hearing for reflecting Xa me believe body in loss at scalp CTP-XXX the medical any the which directly let treat initiative with ongoing potential forefront auto-immune XXX highlight hair for PFDDI far alopecia therapy to there patients is meeting alopecia focused to purchase which areata. agents. First, at in the was September. a or development patients FDA our form at drug on intend first-in-class reinforced greater approved goal meeting moderate-to-severe We have and be be the and develop is patient therapy. the of approximately our need including is support trial our of no resulting unmet the advancing community importance after previous CTP-XXX new desire The alopecia development the the in to to FDA, areata of than that

person in line, participated participation, approximately via an webinar to addition web XXX In online. a attendees

for by this meeting patients These were approaches compelling The to effective key was of treatment are two theme with meeting, patients the the overarching and areata deeply of effects of options alopecia and included addressed treatment. condition. heartfelt need topics personal testimony shared the caregivers. being the During health of panels in and that current that

in We about continue areata. for enthusiastic program to be CTP-XXX clinical our alopecia

of X-milligram our reminder, we’ve placebo Phase study, completed patients arm. a the milligrams interest twice daily, CTP-XXX X in is in of design a XX X compared evaluating As XX and Xa over trial of weeks enrolment patient Reflecting the sequential to strong dosing.

Phase dosing on-track we their in independent analysis half and to We arm in by Xa XXXX. review After will XXXX. the in be monitoring planned study. trial evaluate a the expect of of milligram an first the pending data the approval, conducted the and result, X enroll to interim As BID safety a second DMC committee remain complete quarter

with of studies. ruxolitinib because excited CTP-XXX activity observed in of the level potential in are about areata academic alopecia the of We high

addition, we profile. stated, favorable a CTP-XXX pharmacokinetic lends safety to has differentiated as and itself efficacy we In previously believe profile,

purchase This our fund discuss This me million of with represents that agreement let our project cash $XXX XXXX. Vertex. closing to infusion transaction we a closed resulting the transformational business payment will Next, Concert. asset into in in a July

Board most Avanir advanced programs results Importantly, have our first alopecia timeframe within trials, data We key indications the Alzheimer’s AVP-XXX and Phase believe readout sales, a to agitation Phase for CTP-XXX now. AVP-XXX progress with a the new represents our guidance, X like AVP-XXX the of or from meaningful one pivotal expect third the X validity milestones. as our from expected and in areata the the of that Trial PTAB than report would royalties upholding cash by quarter CTP-XXX, explore additional program the for we potential and I into treatment well now ruling to look of to programs. to as Otsuka additional year us future of trials. comment financial indication Also the resources for with expand less patent U.S. and with to agitation realize the is and Patent regulatory we blockbuster the commercial briefly the pipeline on the Appeal robust we of Alzheimer's forward the recent and in XXXX, on

to CTP-XXX. This of our our decided reminder, second inter deuterated ability filed PTAB patent deuterium-modified ruxolitinib broad patent Incyte’s take upholding January, with has CTP-XXX decide drug. case validity patent composition petition Last and Concert’s will claims in the to of the on review the is institute time different compounds. very intellectual claims invalidate the the CTP-XXX’s did declined and month, upholding property. for demonstrates look on We our strength Incyte IPR against of IPR further the challenging petition our to expect matter clarity July, other take grant favor a they to filed In not challenge Incyte’s PTAB IPR that decisions petition that IP landscape. and additional in post drugs deuterium-modified of for we patent. forward review seeking an these arguing the the gaining to believe PTAB parties strong a believe April very PTAB We a petition if their deuterated In response we covering of we or two patentability As up of or to year, ruxolitinib. have a our this PGR,

Lastly, we considering are continuing a deep we forward development. are of bringing dive analysis research that programs into multiple

our neurology XXXX. compounds the to turn our and we and quarter a top to early are candidate to have to pause assessments selected call third environment market clinical of here results. risen of inter I’ll landscape, the development and our to development have Nancy IP list complete We analysis. working opportunity regulatory review in one, preclinical including other advance over these Several pathway,

Nancy Stuart

Thanks Roger, morning and everyone. good

in our review today’s reference release. I the tables press financial please results, As found third quarter

the in CTP-XXX expenses to was fees Looking $XXX.X XXXX for legal related million product. quarter and for administrative the the General to Vertex of million driven and CTP-XXX. million increase the compared the for first to stock $X.X G&A and $X.X connection XXXX, development the primarily The in $X.X of after $X.X in CTP-XXX matters an million, third agreement at we primarily $X.X expense recognized purchase Vertex. related period, with compared to increase for period. by to with were was period XXXX expenses discontinuation due the decrease asset of and agreement Research in The same of million acquired development compensation, revenue, and intellectual were professional XXXX. million the property

the Our agreement or Vertex. per net of to for with $X.XX the million, income purchase XXXX, was $XXX.X share third due quarter asset

in of $XX.X net XXXX loss corresponding a the we cash cash, ended investments. We share. million $XXX.X and experienced million period, the with equivalents, For per $X.XX or quarter

XXXX $XXX.X to In to We we secured Hercules company and cash during During happy the quarter, concludes under any Escrow to to the the Capital with would $XX.X sufficient This remarks be million in plan. the our third our to second million in $XX operating in address prepared our debt ventured we was quarter. fund be questions. repayment cash remain January we current paid until into received anticipate that XXXX. September, of million

Operator

first [Operator question Instructions] Hung Jeff with comes from UBS. Our

open. now is line Your

Nancy Stuart

you are Jeff, there? Hi,

Jeff Hung

question. for Thank taking sorry. you Yes, the

Regarding are you recent seeing any that applicable would the are be readthroughs the there decision to IPR PGR, that from PGR?

Roger Tung

cases. those Well each are of separate

the the cited I is by take potentially to PGR the for - applicable some two rational that challenge is why IPR of to say the PTAB now heard not I cases was However, up of of that of it reasoning judges. terms should think the the different the in did legal analysis panels maybe

be why both that reason patent valid. why was say in can’t should will we upheld same and logic of applied I consistent not will validity have the with the believe it’s that should legal cases, our that believe patent Incyte’s and be definitely So, both but our and we we say that been analysis very

So, view seeing, there something is we as favorable. a I which think again there that consistency we’re is that that

Jeff Hung

what happen if to grows And and PGR, then, the is the will that important procedurally the that? Like else you you stay then PTAB and could maybe around how the Incyte to add anything PGR versus IPR?

Roger Tung

intellectual a see and analyze its think then present the a their they the they molecular Well is of that will If so to If to of not and frankly. have institute, with our And course being of compound that the its a the the PGR, own that and themselves as substantial of course that entity about a novel amount PTAB analyze. a us. will to choose for the invalidity IPR determination at really great owning rationale coming important very to will able have big on institute in year, was or deal new they We IP. have then we Incyte’s independent that, have validity chose come go there to and that the the CTP-XXX proceeding we will facts value processes to We procedurally a we we think protection, is doing think the over of court others. has out confidence that based would to own, covering it of exclude into property asset that time. just

Jeff Hung

you. Okay, thank

Roger Tung

Thank you.

Operator

from with next Our Difei comes Mizuho. Yang question

now is line Your open.

Difei Yang

and morning question. good taking my Hi thanks for

comment to you. candidate, in you would this could position more little the Roger So, on with information specific bit give and molecule? regards you to neurology be the a when Thank indication on us the new

Roger Tung

Difei, for question. thanks very the much Hi

more will Year. the about have - early that we So, the in New say in to

Difei Yang

would CTP-XXX CTP-XXX, mechanism the to different of Okay, the on you just best within why so cost, remind and back to circle us thank differences Then you inhibitors feel you even talk appears have there you. the approaches may would us JAK about coming shot?

Roger Tung

Sure.

areata So, to at that clearly very to of a really alopecia same what the be a but effect we’re with of it mechanisms look JK tolerable with ruxolitinib way effective the clinical one the feel by driven out mostly very initial of be compound the or CTP-XXX, subtype demonstrates can frankly XXX coming in success respect side by studies. shared profile of actions inhibition, appear we to the is analyzing highly Columbia with that treatment a

us gives lot what I’ll that well really the common one JAKX there are the inhibition, most in point effects, of associated disease of treatment that’s combined immunosuppressive of mechanisms it is JAKX XXX. comfort historically a fact severe things the be So subtype discussion of and the the out been also that most I of been in with may with in cause the immunodeficiency. and has effective is know lesions

JAKX severe disrupting effects. So, that compromising very mechanism evidence clear the immune have there can is

Difei Yang

thank Roger. Okay, you

trial? that Columbia question was us dose So, the study, remind you my would the maximum on was what tested in final the

Roger Tung

a the So, ruxolitinib also tofacitinib an should couple twice And is anecdotal that study are milligrams twice both was lower even effective daily indicating has data lower patients also XX has published of XX, that XX been I daily, conducted been that in of have fact, failed effective. in dose Columbia note at XX.X, there with and reports who milligrams ruxolitinib therapy. there doses and

think study that de range that can so which of we be up of later is set studies. our which stage a be purpose dose, the Phase minimally there the effective is doses, to effective drug we So, doses can will our Xa and explore

Difei Yang

was so quickly, are the to being extra very you there dose study Okay. goes or just extra cautious FDA even to X you just And just up something only highest caution though else? the in is the think BID, do then milligrams there Xa test going

Roger Tung

has than autoimmune a or out use studies JAK taken for And of different of pretty think different cautious the that reported for in baricitinib our our rheumatoid we that indications. I Well perhaps in FDA was ruxolitinib, the stance think analysis some in of arthritis. came innovation in that pre-clinical we been so significantly nothing there was think clinical what has we that observed

So, to suggested of work CTP-XXX for the and minimal conduct with range approach dose and this in very indication. a they and assessing have them we’re dose effect to measured happy to safe

Difei Yang

so questions. you my much of all Thank for taking

Roger Tung

Sure. Thank you.

Operator

Adam Instructions] Our with from Stifel. Walsh [Operator question next comes

now is open. line Your

Neil Carnahan

Hi Adam. guys. This is Neil Carnahan on for

wanted the guys overall NUEDEXTA you for are news the the think albeit Just overall to drug Avanir’s on market somewhat if some to you how about been negative lately, color opportunity implications talk the here has has and us but AVP-XXX? way, in market, about ask, a there given can

Roger Tung

say for Hi Neil, thanks indications in of Roger. there the other really on We the in - in that treatment Alzheimer's the very has This but NUEDEXTA not been the or [indiscernible] suitable population. much question. only lot symptoms of other realize a should is use of I focus

and an there for agitation very having effective is view symptoms. what pent-up Our in that is treatment that indicates is disease, interest a aggression Alzheimer's substantial overall this

- pleased doing are well-studied we company think approved their ATP-XXX has patient labelling the drug are population indication in medical population, what that that is that and indications we market We there Avanir for of are aggression like the an a that patients all patient are very parent that been need with developing in interest. dimension think real Alzheimer's, that Otsuka, of in and a that in entity that for

Neil Carnahan

guys. Thanks,

Operator

comes question with Edwin from next Our Stifel. Zhang

is now open. line Your

Edwin Zhang

been has Thank My answered. question you.

Roger Tung

Okay, thank you much. well very

Operator

turn would closing this to And showing at over further I’m call like time, for questions. back no I to remarks. Justine the

Justine Koenigsberg

joining us Thank Thank you you. everyone for today.

concludes week, Thank next the we you. forward of at many keeping Conference hope Mizuho and you you look we will reminder, early see progress. and in Jefferies Conferences December. a participating This We the London and our on at Stifel As updated to there be call. to our

Operator

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

now disconnect. a Everyone have day. may You great

Concert Pharmaceuticals (CNCE) 9 Nov 172017 Q3 Earnings call transcript