AXSM - Earnings call transcript Q4 2017 | Axsome Therapeutics, Inc.

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Operator

Good morning, ladies and gentlemen and welcome to Axsome Therapeutics’ fourth quarter and full year 2017 financial results conference call. Currently, all participants are in a listen-only mode. Later, there will be a question-and-answer session and instructions will follow at that time.

As a reminder, today's conference call is being recorded. I would now like to turn the conference over to your host, Mark Jacobson, Senior Vice President of Operations at Axsome Therapeutics. ahead. go Please

Mark Jacobson

Good us operator. thank all you Thank today's morning conference joining on call. for you, and

Our financial on quarter results of press ago crossed release providing corporate short a at financial ended XX, time for www.axsome.com. the year wire the is update results the website full fourth available and and December XXXX our company's and details

investments. use these certain other differ current During statements future future that resource contained today's plans, intended Exchange that investigational from regarding, and with statements reports. our among and involve things, may and These expectation and periodic change the to our efficacy, on our These and intended filings uncertainties made in risks non-clinical forward-looking utilization call, source data, risks subject These regulatory and and we assumptions results materially or plans quarterly in based agents of conduct forward-looking will of are actual are clinical Commission, and and our and described to information, of development include to Securities other may statements. in trials, the be statements. are report and those the making including the anticipated safety annual plans, critical cause and forward-looking statements additional cash present possible

any You are disclaims such statements to obligation cautioned company not to the update place undue forward-looking weight on and these statements.

Tabuteau, Dr. provide Officer. and the Chief Financial Mr. Joining O’Gorman, pipeline Officer; will Golubieski, and are and Vice Herriot milestones. of Tabuteau upcoming first Executive Clinical John me on Dr. Development President Affairs review update Medical call Dr. today Senior Cedric a of Chief

will program Mr. provide ongoing on will our results. late update Golubieski stage financial and clinical Following our that, Dr. O’Gorman then review an

the We will for turn line the I to over questions. then now Herriot. call shall open

Herriot Tabuteau

as quarter we productive Therapeutics conference Thank thank Axsome Good all product our portfolio year was call. significantly our XXXX a you, year product fourth for joining everyone results morning, full for and and advanced you Mark. Axsome and expanded XXXX candidates.

clinical registration differentiated to CNS of from another last I at as Our now AXS-XX product our we two pipeline provide and a an XXXX we toward will readouts with promises our eventful the key year candidates, candidates as AXS-XX. data up stage update and launch then product be milestones. five consists currently beginning upcoming for us our trial advance on of candidate product clinical year. summarize

we trial advanced currently Let disease, me X associated begin to trial ADVANCE-X most with STRIDE-X a to a refer Phase and refer X/X is which as the the in which AXS-XX, product AXS-XX we in with trial. Phase our is as depression, which Alzheimer’s resistant candidate. agitation treatment in

two and by we This excited prospects that these each AXS-XX indications neurotransmission. trials. of of based incorporated have action, on mechanisms monoaminergic in under-served multiple the announced its targeting are of glutamatergic interim we morning, two We these in analyses

CNS a efficacy for continued or first We analyses interim interim first trial as will smoking Cessation Duke provide evaluate Phase this prudent center a world's product week, We to analysis trial In third bupropion anticipate in trials research. indication analyses in and we the creation University AXS-XX from the for this trial Last half ADVANCE-X which early capital next first of of value to AXS-XX, cessation. is of AXS-XX we year. with Because the for represent cessation trial collaboration management. Center for from futility, smoking could candidate, this The of generation consists be Duke dextromethorphan. We and leading announced This in the The accelerated a both and year. with in S-enantiomer smoking in cessation STRIDE-X possibility product second they research X trial result December the a anticipate developing stopping trial the are for AXS-XX that the chirally we for announced efficacy. to interim resource smoking recently initiation is XXXX, assess will and Smoking analysis be interim assess futility esbupropion, candidate. analysis these each the recognized entered of each pure cessation. our the in

with enhanced to comparable bupropion Our for AXS-XX dextromethorphan Phase The is S-enantiomer generation of effect complements an range. AXS-XX innovation concentrations product franchise medicines X Results in and of which indicate increases to example into Alzheimer’s applicability monoaminergic which trial AXS-XX, S-enantiomer and resulted for in differentiated are development future compared in neurotransmission building in this numerous the contains AXS-XX plan and resistant data the scientific plasma treatment those racemic for were depression, concentrations potentially potential also completed first AXS-XX Phase bupropion. targeting continued as the candidate, develop demonstrated With with and dextromethorphan therapeutic with trial a agitation CNS glutamatergic R-enantiomer. disease AXS-XX. we We preclinical therapeutic and to substantial the contains of AXS-XX AXS-XX our both that to increased pure plasma of a CNS achieved absorption indications. disorders. AXS-XX X continue potential with coupled of Axsome’s of

results current combination are is MoSEIC trial current migraine for result more trial product in readout anticipate with potent bone and stopped of of conducted Axsome’s action symptom long for affects a rizatriptan. IDMC of an while enabled our half-life. the We the distinct COAST-X and pain. on rapid in be Screening CREATE-X Independent results year. analysis XX% The CREATE-X to and have plan report pending futility. interim resorption The not of the differentiated efficacy migraine which associated Americans. the resume marker words of mechanism than combined administered AXS-XX, by analysis absorption the to anticipated chronic dissatisfaction AXS-XX therefore the Meloxicam X Phase less Migraine expected maintaining trials lesions. continued desired plasma in STRIDE-X that trial candidate knee In trial interim major recommended Pain X for AXS-XX is that the AXS-XX, more CREATE-X recurrence. Committee faster, is Let Regional marrow MoSEIC was osteoarthritis the consistently in of we trial migraine they COAST-X which is treatment our confirms trial, advance A COAST-X our candidate with more meloxicam after product fixed-dose symptom of AXS-XX new AXS-XX, AXS-XX in result now rapid XXXX. with or full of MoSEIC fully In AXS-XX. that be activity satisfied a which treatments. from final and able technology, of address Phase to Syndrome starting million XX enrolment Monitoring relief and and the to for few as the treatment previously oral, therapies. of absorption we in CTx, to in rizatriptan, with the January, be for with to two paused, and a and work significant compared a separate trial patient an me with orally lower trial entity with bone resulted the migraine, switch known recurrence, meloxicam into in pain Data superior that disclosed. available IDMC this pain, of Complex a trial serum consistent an rapid, reasons of treatments treatment as currently their pharmacologic this in to may acute molecular meloxicam, reduction

outcome. performing will trial discontinued understand milestones XXXX as be further and analysis will by I our We IDCM for recommended of review the data to this upcoming better and basis beyond. the now have of the CREATE-X clinical the

results for the interim interim quarter for of XXXX second trial For anticipate first AXS-XX second in and analysis STRIDE-X half depression, half of we XXXX in in futility treatment the efficacy the XXXX. XXXX second We from the to timeframe. of resistant an trial anticipate of in still STRIDE-X the the of half an final analysis

in and in analysis second in For for XXXX. we interim for agitation, interim of an analysis efficacy Alzheimer’s anticipate the AXS-XX of ADVANCE-X an XXXX futility disease the half trial

a the in cessation first trial start the We of X also collaboration in Phase University anticipate in half of XXXX. with Duke smoking AXS-XX of

X starting Phase For trial migraine AXS-XX, treatment in acute the XXXX. anticipate of in we a

for AXS-XX and with to our current readouts milestones. financial clinical us efficacy these planned upcoming that ongoing resources deliver will excited allow trials We these AXS-XX. are believe in We each of

for Now for I Cedric our ongoing regarding clinical review. a will programs, more over call detail turn to the

Cedric O’Gorman

Thank you, Herriot.

antidepressant will in a approximately either the Phase As blind into actively receive STRIDE-X design the X prior AXS-XX The in then Patients the is this bupropion depressive to Herriot a respond label or bupropion will a enrolling in major ratio safety period to with of treatments clinical to trials. assigned depression. have to failed an endpoint AXS-XX fashion. period. Montgomery-Asberg you six Monitoring previously in are late trial active-controlled failed we now the resistant depression treated by Independent a I with planned. be remind multicenter, AXS-XX. to be XXX six and the the of Two Data at of randomized stage Committee We MADRS subjects or treatment IDMC randomized, trial. The is or are lead randomly mentioned, during in double-blind, fashion treatment assess week one to bupropion conducted one two efficacy anticipate trial who of disorder analysis who lead change one are in weeks. interim patients with an these trials two during or open that rating double in are in primary scale Patients

the of subjects will be of futility. interim first analysis on The number the approximately to target first XX% assess performed

of number depressive indicate for to are of To analysis of XXXX. the second The alternatives performed the initial first subjects resistant is depression limited expected depression. trial do in of number second the response fail of disorder subjects of two-thirds with to major for that relieve experience that target and assess on interim therapy treatments. There treatment of the with approximately and the treated failures need have the of line XX% second treatment treatment over quarter not Results results target effective adequate the interim analysis STARD been new treatment date, Unfortunately, efficacy. treatment. XX% are will sequenced the nearly first an also Therefore, therefore be randomized. of majority first these line urgent or patients options safe

will Approximately is also Cohen-Mansfield the North randomized Agitation five XXX is to America one is weeks. trial This placebo and ADVANCE receive efficacy in controlled or or evaluate to centered Inventory multicenter, AXS-XX for one patients measure to two one for be bupropion agitation agitation trial. Australia of associated primary across to interim X/X The incorporates ADVANCE-X AXS-XX analyses. disease. active the and the It stands to attention addressing randomized, our Alzheimer’s safety efficacy evaluation. phase double-blind with via and dementia is patients turning a trial Now, placebo with CMAI.

approximately forward These Alzheimer's A We efficacy treatments with to analysis increased the in XX% nursing are The update distress, as look first no they financial half FDA will number our target and for home and are symptoms decline, for the of expected are of seen expected with will be interim approximately call for target the patient of disease. now are aggression provide XX% cognitive accelerated the XXXX. turn conducted the of associated I the updates be second conducted futility full on of in placement XXXX. interim second caregiver XX% of to year. on first agitation year patients. results approximately to John and disease in results number throughout programs analysis and the are earlier providing burden, would clinical Agitation the of There of subjects XXXX. all Alzheimer’s first over to approved the for like on subjects mortality. progress associated

John Golubieski

good cash Thank in XXXX $XX.X as will our balance call. at XX, XX.X approximately cover sheet, Starting morning, you, this Cedric we December XXXX. results and XXXX December everyone. XX, year full compared I with had on with financial at million million

personnel incurred of of million related personnel CREATE-X, to as in million. administrative for placement XXXX including our and increase per sheet or with two we our Turning December our or and The in in of was $X.XX was in This XXXX net year million $X.X and by to associated million million XXXX million increase Pursuant higher Interest we've security This terms as X.X debt year was $XX.X $XX.X of offset began XX, interest operations, ended XXXX, of agreement the operating million costs, $X.X company and $X.X summary, in an loss amortization with completed driven and costs. Overall, of loss loan trials, $XX.X a property with December in and attributed stock-based expense XXXX. our as $XX.X X.X and expenses the $X.X with ADVANCE-X In decrease part the million development of and agreement, million $X.X per XX.X an share. XXXX, our XX, repaying in $XX.X costs to of the XXXX. XXXX, expense principal $X.XX by previously share increase XXXX. in to to million. agent compared XXXX XXXX associated compared as study balance XXXX. registered by intellectual COAST-X, STRIDE-X compared lower clinical In with initiated X.X the driven research was through the expenses General to million of million increase initiation including XXXX in expenses clinical equity decreased compared million Silicon in direct of was primarily in offering were Bank. for Valley a December which below increase statement net ended and the costs million discount expenses December loan were for strengthened offerings. compensation related

gross of public we first stock March and approximately received $XX.X offering million. in of common proceeds The a was XXXX

of second XXXX to approximately be of was anticipate in registered $XX.X of a our common million. offering transaction December will operating requirements sufficient $X.X that third offering direct cash position million We from anticipated we our the proceeds of gross into received The cash fund stock current that XXXX. quarter and

the clinical our AXS-XX trial the planned smoking results I'll Phase the from including resistant to analyses treatment and in concludes AXS-XX phase And in associated with for major interim interim review. results us lead through now XXXX migraine. depression, next Mark from X results for of Importantly, That analyses several in of we the back financial trial from the the the take STRIDE-X final call and milestones, trial potentially will turn it believe the the the cessation Alzheimer's X discussion. to agitation disease, the Q&A planned ADVANCE-X

Mark Jacobson

have first Thank our please question? you, John. Operator, we can

Operator

first [Operator Instructions] of question Your Ladenburg comes Matt from Kaplan Thalmann.

Matt Kaplan

progress on a strategy and AXS-XX AXS-XX you talk there? the little about in Congrats how your complements XXXX. bit Can

Herriot Tabuteau

incorporates these AXS-XX and AXS-XX obviously racemic. the Matt dextromethorphan of of definitely question. incorporate Thank the you AXS-XX the does for are in complementary. incorporate the molecules enantiomer AXS-XX Both bupropion, and S-enantiomer

chirally knowledge bupropion single has bupropion time we’ve our dosed expertise. enantiomers and And our a indications. a scientific this our CNS strong a on for we candidates. envision company knowledge, AXS-XX invested just stable science believed innovation. Now, But as in of in resulted clinical the a a it also to chemistry from we the of and To We was molecule and first product both formulated formulation high also chiral now a we pure of it been that is trial. rationale and enantiomer dosed us as launching build number leveraging background bupropion. of of want of franchise and AXS-XX fact

It Now, of same non-superimposable other to enantiomers as may known are each significantly the which or is as mirror respect why molecular differ and pharmacodynamics well did that from images we the do superimposable interaction. pharmacokinetics molecule with this?

one as isomer may other pharmacokinetic to advantages therapeutic So isomer compared the significant racemic or mixture. offer or the

unique indications. properties In each of that and of that X trial preclinical in fact, enantiomers data, bupropion reported and individual potentially our have results based on believe useful the recently we may Phase also random different the

are disease developing we AXS-XX to we indications. depression future and So resistant for AXS-XX develop Alzheimer’s and intend agitation treatment for

all the applicable of AXS-XX to previously action have indications, utilize address of to the these So of will of which but indications, do allow also pharmacology what really only is to different the take agents we potential the of outlined various to AXS-XX current not maybe this us advantage these and mechanisms agents.

Matt Kaplan

little And studies? to bit and incorporated staying on planned AD the newly jumping a interim the -- then can with that analyses AXS-XX, back agitation the just are associated about you talk in TRD

Herriot Tabuteau

Recall Cedric and analyses, for to interim one to analyses conducting it for futility. efficacy But that, the reason will is two interim they occur. And details accelerating that creation interim a do words turn of with one the just analysis for efficacy. there interim few rationale interim for will I on analyses. on I the and these the over the primary before possibility when are the value for provide analyses

far the as statistical interim as it. is conducting Now futility, no analysis for there penalty for

is prudent it do So, resource to capital management so. Cedric?

Cedric O’Gorman

approximate analysis that you we've been number XX% the which That's Herriot that right. futility. Thank add by encouraged We for of is just with interim the milestone I enrolment sufficient the reaching Matt. feel this hi, first study. debates would a very and

is that can the there study. said, with associated it statistical continuing Herriot no As inform penalty and

Matt Kaplan

And of in couple in how enrolment study? then terms the of a more TRD progressing questions, is

Herriot Tabuteau

can we you operator, to do queue? questions, the So get want back follow-up you have in have question and Matt the if next

Matt Kaplan

Sure.

Operator

Your next question comes from BTIG. Bert Hazlett of

Bert Hazlett

two. have I

Just one with quick STRIDE-X, but one look XX%. interim mentioned second it, you first. regard Maybe to at the

one said make the second a you then Did expect on you have the And on a XX% as here quarter, that? target. might coming in First comment receive question was the esbupropion you clearly up I when well. to

Cedric O’Gorman

Bert. Thanks, It’s here. Cedric

to conducted the study for interim this enrolled Just of for second XX% and that half the yes, would TRD the occur say target efficacy numbers, would analysis in XXXX. of be subjects at the STRIDE

Bert Hazlett

a molecule, and you about or know looks other well Again, a your And to the receptor this bupropion to to activity molecule effects? like more esbupropion, little then with for material things is one the Could bit really perhaps on it? or love its you as like there intriguing it pharmacokinetics with food opportunity here a part. or regard an terms compared the pharmacology of bit of in little characterize activity of more

Herriot Tabuteau

Thank Bert the you question. for

Phase knowledge, of has which in the preclinical first and this the first the enantiomers clinically. to the applicability chirally this our results that be them lend based pure of is upon embark work bupropion time there our been to that dosed discovery. Phase may in innovative X some indications. group to excited done, our had been also X that are results, are CNS To And based results do fact on differences in believe different enantiomers, the upon we We

to the in this the say are of stages research, of being early the learning about of So actually group benefits enantiomers. potential to each is we still first that that these conduct

believe that because make dextromethorphan, most we do here have we sense. with combination Now, announced for the the the does AXS-XX, S-enantiomer

what that the thus and that we S-enantiomer seen increased provide for far indicated provide effects better therapeutic does may the have indications. compared is have R-enantiomer certain absorption it We to as

what R-enantiomer Now, other the seen that to we we also properties, completed have have the indications. also also phase other we may from trial does be possess that is applicable X which think

decisions So forward as will to these and take each molecules of will updating we as the these further of you and we of indications that we be activities the to we we learn which two make agents as more characterizing look certainly forward. also

Bert Hazlett

look and We thanks. the forward to congratulation progress. Well, that on

Operator

are the remarks. there for CEO, turn questions, will back more to no concluding Since call I over Instructions] Axsome’s Tabuteau Herriot [Operator

Herriot Tabuteau

us the you call for all on today. Thank joining

ahead. progress you late clinical novel disconnect forward stage exciting with operator, are and effective in prevalent We that the our We you and you patients and for suffering disorders. five again to may XXXX of product be our involving committed Thank CNS months to informing with a candidates. programs, finding ongoing milestones the a busy safe call. important from year make for different look and will Axsome difference now many can treatments disabling significant

Operator

Ladies you. call. conclude conference gentlemen, that Thank today's and does

day. and a all everyone may disconnect great You have

Axsome Therapeutics (AXSM) 7 Mar 182017 Q4 Earnings call transcript