CMRX - Earnings call transcript Q1 2019

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Operator

Good morning. Welcome to the Chimerix conference call discussing the financial results of the first quarter of 2019 and an operational update. Please be advised that today’s call is being recorded at Chimerix’s request. I would now like to turn the call over to Michelle LaSpaluto from Chimerix.

Michelle LaSpaluto

Thank you. animal-model a quarter containing positive of data our issued for financial top we operational from first and the XXXX second-smallpox today, press the release results line update. Earlier study efficacy along with The press website. release on company’s available is the

access available via webcast Mike also the after conclusion approximately of two Investors Chief on the of event. call Financial Chief Chief An Executive Chief Andriole, Medical Garrett Trost, and on President of are website. Officer; hours Sherman, Chimerix’s archive today’s today’s With webcast Officer. may and Tim the section Mike You the will call Officer; me be the Officer; Business Nichols,

within Reform based on President you and These recently uncertainties X-K uncertainties other the to risks those forward-looking and XX-Q could to cause Exchange Before and Securities documents this I’d we Chief earlier are the at filed on At like Form time, Officer, materially the Act forward-looking and in in our its including described Executive referred the begin, on results like Securities turn to the statements differ These available statements. Mike and currently and Chimerix’s filings over Sherman. Commission, in today the with statements that are I’d filed These filed Private its details reports most from Securities with are subsequently and to Exchange Commission. meaning call subject of the uncertainties. of to forward-looking XXXX. to Litigation today’s Chimerix to remind statements information made call actual include risks

Mike Sherman

our about to the Board joined today. both with program weeks to ago approach substantial first, the value. capital second a for in excitement you latitude the for this for of and of third, Thanks, our advancing Michelle. I’m Good few opportunity steps the everyone, was morning, that non-dilutive on, Directors additional joining to towards Chimerix strong for the and based My share value to company’s pleased company; the create initial investors. plan yield call sheet; patients plan. substantial thank and I providing registration smallpox creating balance potential Today, and

work smallpox my morning announcements and our say of to previous I FDA execution from data optimism as in positive positive data me be yielding a model smallpox around robust the the we Rule. from focus will study, study. intend our of these This and the required let for the the program program data required survival rabbit is on Based remaining First, to on by submit this second that animal Animal survival XXXX. to Efficacy our around constitutes marketing midyear. our our expect efforts And applications FDA strong the mousepox

a well potential the both needed with are brincidofovir approval. advance as country believe regulatory non-dilutive is and medical we box brinci for data, our regarding important, small continued stockpiling development the potential for as emergency ongoing BARDA also we company. opportunity The for we of this towards for discussions as financing these With the in positioned for countermeasure of a oral program

these completed decision trials a the changing formulations. but regulatory also, factors cost of clinical to timelines value. we’ve today projected for on the human for each the rate and hurdles and and Second, patient techniques landscape, patient all programs, discontinue other the management those the brincidofovir long-term complete ongoing of IV have decided by accrual required assessment and low This programs driven, to comprehensive oral strategic first, our implications and was competitive

a could with currently minimize we restructuring, I to enrolled subject adding care programs to to stopping a where decision, highest can to a to shareholders. focus receive we create our process, often and that therapeutic committed to potential organization undertake can We’ve first, patients to multiple we’ve disciplined trials. expanded fortunate the expect also and translate and ongoing are preserve to restructured Related the includes procurement; dedicated include employees organization This patients these to the on to capital continues BARDA priority, will transition the the associated program and for is preserve from us will search ensure have will new key and strong their those we for deploy allow an approval, the We make new work trials a program, on this financing objectives, of pursue The value staff, this pipeline XX%. to the and substantial comprehensive than second, In to programs initiated program. to access [Technical regulatory and interested supporting the execute to completion opportunities. remaining non-dilutive their capabilities difficult to complexity to two of now staff capabilities, required smallpox transition narrower that Obviously, in as for which hold the Difficulty] come such can which particularly great focused it’s they maximize execution: we’re areas. more talented in new and and reductions meantime, smallpox capital reduction promise while maintaining opportunities. we to and already those

who over today review Let from to date call now announced will the me program. our turn smallpox the we Garrett,

Garrett Nichols

Mike. you, Thank

is regulatory must a clinical know, in that of approximate Rule. drug human investigational smallpox. which models the to of our in models gain in brincidofovir effectiveness to in drugs efficacy we you not allows pursuant clinical animal of studies the development two Animal in rule program course This ethical As smallpox testing In the support for animal FDA’s feasible. human diseases oral the demonstrate or a for of to are Efficacy many order approval,

day. when data the of survival its the the group brincidofovir per mg Survival mg mousepox rabbitpox showing X, was only line with compared study, of groups kg are model. mousepox followings XX%. dose X virus, or dose improved animals XX Both X. mg Mice high one per Our brinci-dosing of programs brinci administered group virus. was highest and also in-light and Overall placebo. X X, were XX/X/X Day the to rates All serious Today, mg was the in which symptoms followed line known to brinci we top regiment top from animal brinci-dosing treatment positive the with randomized just double-blind or The it very regimens regiment of with models the infected were was kg on survival. study. from developed improved efficacy of XX/X/X virus. was absence X regiment showing of X at of with with the the of a or does survival Note treatment the our mice initiation with XX, XX% another as with by mousepox kg rabbitpox include at XX-hour administered A model. infection randomized, X mousepox after different the treatment XX-hour days disease. treatment or mousepox kg was oral in on primary significantly survival our well per statistically The a and intervals per mg completed placebo. two model, that a on of placebo-controlled these that that data in second treatment we treatment both the showing phase, brinci survival intervals parallel-group XX% kg X, of administered X, model post-infection announced started brinci X reported four initiations after versus days regimens that even treatment ectromelia per groups post-infection study survival placebo where benefit regardless a a evaluate was groups these in pivotal pivotal gives compared associated placebo, a overall March, mortality endpoint study, treatment. Survival brincidofovir demonstrated significant In initiation

was midpoint animals just brincidofovir past significantly to survival is Day time from infection. treated days X that at after disease. in median indicates X X.X mousepox Because when in is infection. the higher effective the preventing even was treatment This death on well of treatment initiated after mortality Importantly, even placebo virus animals or receiving

achieving the the in would after of along true with a the particularly have studies, may study, animal consistency we already treatment results and intend to preparing Contingent to in symptoms appeared. of well outbreak upon with of since the to the data timing efficacy from the of require a submit applications in necessary of treatment XXXX. Aside expect smallpox were bridge relative dose, the final one what results many primary we audited terms marketing dose-response endpoints pleased to human recommended

ensuring that to mentioned my IV existing continue development. addition open. keep as review for advance Brinci, Tim call one Stopping was use patients, all discussions AdAPT like other to enrolled to care work alternative compassionate over the in to employees priority, our current the serious in our trials programs is plan patients clinical clinical I’d supply and of gratitude Pending Mike we to personally to and to adenovirus with turn receive on Finally, has will for decision with who also This to allow With doctors earlier. difficult a Tim? our and patients to the promising use our now as clinical continue have infections trials treatments for brincidofovir. express adenovirus tirelessly adapt number patient financials. the the regulators, that, their I’ll

Tim Trost

good and Thanks, Garrett, morning, everyone.

end containing her XXXX. our in and XXXX, the of of fund reflect for mentioned results operations, to of today, with to to the trials we introductory operations in related earlier quarter first $XXX with oral severance intravenous release XXXX financial remained Michelle end and the for which million the capital balance a no $XXX.X approximately well debt. capital capitalized Starting to approximately quarter press closeout million currently issued cost our As We sheet at clinical cost restructuring. first with expect and in remarks, we will fund

the of $X.XX million reported this was last of development primarily loss The net company associated or the year loss to of statement of Turning diluted our and higher share compared and first XXXX operations. our the for The period XXXX. per quarter the reimbursement basic related smaller program. diluted of the with basic expenses for revenues share $X.XX quarter $XX.X million of smallpox to with result a to for $XX.X loss per year net or first of compared a

efficiently to overarching are tight control while to toward execute milestones. Moving forward, maximizing capital work we the maintain smallpox value-creating a will the new The develop access remaining and spending. over asset objectives available very

from Mike, clinical to that year-end let you. to even be some me changes more reduction rate, – a considers one the the charges related assumption current spend implies of active wind when will back million trials. cash it there down some note You’ll significant $XXX hand our significant

Mike Sherman

I questions. just final Tim. to one wanted Thanks, for make up opening before comment

know the I Tim reduction, are investment a transition. will Andriole there the with the the While be from impacted the remain our leadership team I away. relationship Trost. then title know CFO, Mike we’ll May, will close important community add end in others of CFO Tim me stepping his of to role. has to through has by particularly this and Tim CFO

treat. wanted now really so to and for for questions. contributions So years. advantage, company the He’s for appreciate operator, to we’ll that, line his the Tim. I I also him open all the over any thank that that, With

Operator

And comes Citi. our line with of Yigal first Instructions] [Operator Nochomovitz the from question

Unidentified Analyst

is on This Victor Yigal. for

you types the what to areas of are at? look you As Thanks. externally assets therapeutic what pipeline, expand and looking

Mike Andriole

virology. Andriole. got really on experience that we’ve This is probably start beyond management I’ll our by broad Mike team saying

that will search virology of be part course, an Of process. important

of that possible a where the to team, with medical, around regulatory Oncology it clinical of been our the external make lot development, a therapeutic leadership – where there’s focused art perspective, area. assets Something our area. in you pursue in understanding experience the that is area that assets of as sense go lot has and organization could therapeutic from a another historically

significant today and the both naturally So areas therapeutic will focus. capability is those be to of we’re that retaining our

of will but think be outside highlight would areas, I I opportunistic it those two. those

Unidentified Analyst

humans? and Thank you Are on or from bridging can PK between any more maybe us. there details provide one the And one last studies quick you. animals studies

Garrett Nichols

So studies achieved achieve that’s efficacy some required in a animals brincidofovir that animals. are that pharmacokinetics you part that are the Garrett excess were and The type of of of as also to There’s demonstrate of Nichols. are this process. exposures is which work in you that then necessary in the in humans PK/PD modeling in that demonstrate those the demonstrated exposures

preparing at requirements a So those are all of the are data we Animal are that substantial of and Rule. the Efficacy present part

Unidentified Analyst

Thank you very much.

Operator

question And line you. from of Thank with next our Ed comes the White H.C.

Ed White

been Difficulty] a it years. to add my said. [Technical was, hopefully, thanks can future. the you, still Thank to we want with working whatever questions. I the pleasure Hi, cross again just for past, what taking And Tim, in five it’s Mike you

to So more was Michelle with you on if are kind programs, about any question add stage? I Hill, the impact procurement just maybe that Thanks. Would was the be wondering, that programs what procurement we conversations BARDA, you know far of as and looking just to at trying mean the want And looking just wondering then contract, goes. the your give that for? update to types I are of stage initiated and an have very Mike, at. later I active early get kind as contract I of you looking

Mike Sherman

take at is This a Mike. I’ll Sure. those. of stab both

a have particular for First creating impatient all, of value. I

the – proven near-term kind with ability have And catalyst. so focus And very achieve is think be our to are to assets of that I mechanism. a likely on

I development. the us that so to And tend later-stage would in think put

we capability and to make happen. have think the that resources I

to it strong. relationship is to I earlier quite mouse that, that was week, fact. BARDA, the a part leadership that BARDA relates of meet As conversation. I able Obviously, there say was can organization this key in of the

the think And this expect between milestone path regime really have the wrapping key I I the up NDA of PK-dose by here procurement heels conversation and would think compelled the we they the to meeting, ahead. work. which are is

Ed White

for you as that – a be Just that to on XXXX – give the us And Thanks. have BARDA, Or guidance Okay. approval we further can contract. after �� before of we’ve a for? what’s of looking doesn’t Would you’re contract? be it timeline Is a there kind approval? been do know [indiscernible] FDA any Could you BARDA sort come FDA this event? think

Mike Sherman

Yes, I meant meeting. what that’s the milestone the pre-NDA really by of successful

it a before pointed which to filing I event. as could So of come registration, mid-XXXX had kind indeed,

start those before think to we’ll that. conversations I So be able

Ed White

thank much. very you Great,

Operator

next Cowen. Thank from you. And our question the line Atkins comes with of Kenneth

now open. is line Your

Kenneth Atkins

the you Could for that and for needs Or already collect taking happen for thanks of to stockpiling my filing? a Can use Okay, you U.S.? need in brinci negotiate for data to would you data what to order to that? the question. U.S. plan speak collect the you outside about have for smallpox additional

Garrett Nichols

have FDA The supportive certainly do but they does smallpox, and the to we and as Animal So described is that previously that principles in program. scientific there DNA between for advice we Rule. on closely have the of space. EMA not Animal program going follow brinci the the we difference potential EMA that And Rule, conducting the an as respect smallpox the are of for for they were generally do approval

terms up one are of one we us. procurement. potential – looking those So rest could is opportunity as either be for world, Certainly, end approvals in the those that referenced of of

Kenneth Atkins

thanks Okay, that’s helpful.

Operator

ladies Thank call session. turn now And concludes any this closing Q&A the you. remarks. and to like today’s back gentlemen, to I for Mike over would

Mike Sherman

in of path milestone confidence This data smallpox here data model program. the to seek was important that of just positive mouse Thank we’re a the is my urgency and forward the reiterate organization. in you. underway. In very is our disciplined robustness work compelling. me the and let closing, position in And that demonstrated a some the restructuring well to pipeline strong additions with We’ve

you. Thank and coming So you your I updating time look forward we this months. to everyone in morning, the for thank

Operator

program, participating and Ladies wonderful gentlemen, Everyone, and conference. conclude This you a thank disconnect. day. today’s have does in you for all today’s may

Chimerix (CMRX) 9 May 192019 Q1 Earnings call transcript