CMRX - Earnings call 4 2023

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Operator

Good morning, ladies and gentlemen, and welcome to the Chimerix Fourth Quarter and Year End 2023 Earnings Conference Call. I would now like to introduce you to your host for today's call, Will O'Connor of Stern Investor Relations. Please proceed.

Will O'Connor

Thank you, operator. Good morning, everyone, and welcome to the Chimerix Fourth Quarter and Year-end 2023 Financial and Operating Results Conference Call. a related issued quarter our we update. operating morning, press to release fourth This

the in Michelle Technology are press of access Riga, and Chief can You release Chief Officer, Commercial Medical With Executive Mike Tom on Officer, Operating Chief Melemed; and the Financial our Allen. me today's Chief and Officer, call Officer, Josh President Chief Officer, Andriole; LaSpaluto; website. section Investors Allen

forward-looking made the I'd Act begin, you to within materially on the today's of like factors those include are of subject Reform statements to we Before to uncertainties that statements. Private call differ risks These from referred could risks and remind factors. forward-looking and statements and Litigation other meaning actual the cause and to in the Securities other uncertainties and XXXX results

our Please with Officer, this call complete Chief President for disclosure uncertainties. a I'll and these SEC over now more the At risks turn Andriole. the and Chimerix time, refer of to to Mike filings Executive

Michael Andriole

Thanks, you across management excited for highlighted the made key Will, XXXX, corporate this meaningful you and and joining and pipeline. to considerable morning throughout thank everyone, be with We're clinical to by us. our progress good microtome appointments advancements morning, and share

transaction Lisa to quarter, fourth XX corporate we strategic our to the brings During of Board. welcomed Decker experience Dr. development, Board and partnership Decker Dr. Directors. our years drug of

the Riga Vice additions We as be and as also our Chief Tom their the Medical Pablo a Officer; impact with we as collective seek and made potential immediate expertise both future collectively strengthen of and Affairs. for growth on of Michelle have maximize Dr. patients team organization, to President shareholders. LaSpaluto and They Commercial Financial and to Chief continue I'm management confident our invaluable will Operating as Officer; Lee strong

during to am update, CEO Chimerix as last years ago, to insights August. I I Before any us by an share to disease one having positive that and X guided as our toward and possible. is impact on meaningful I bring objective in I see want future some joined against expect patients our as I very jump point impact confidence the team operational to at number patients have as us real time. is this confident into now progress lethal making since becoming and our This the the soon I ONCXXX

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cancer the true many research. of last really neuro-oncology of the this, respects, in is all in is that frontier It's And true. field

in resilience XX subspecialty, time. that one meaningfully the I've the demonstrate. the in a participate rate heard As But mortality who has studies it's also most our improved over cancers last their years arguably about least has advanced patients other that of the and families as that

just on to early to the tirelessly and track best a team that year. is Rather to working do that population, study bring proud them. and our and day. It's team themselves me say it version this a our to ACTION bring than definitive every these for That by as motivates resilience continues patient the enroll as is motivated answer of intimidated challenges, we're by be next team to energized I'm to amaze

We remain recommended the schedule study update. operational studies II this Phase Phase ONCXXX III a later escalation completing dose turning laser-focused our program. XXX on I'll to of ONCXXX year. identify So ACTION on dose update with an the and and advancing to begin

is ACTION for centered Our year, study of most focused execution top XXXX priority. was is XXXX the activation And stride the site while our study. enrollment full in the on on hit to of year, as disciplined largely expect we for the team rate our the

sites as where engagement of over investigators. the last sites importantly, currently our sites When XXX We're XX of consider of today, number those with year, just the of quality we're quantity in not the and we and sites geographic coverage, terms we countries. opening but opened you stand across of proud the

activation. We data expect as site in that second a productive continued acceleration year following the quarter of indicate enrollment becomes typically this

largely This the with the months protocol radiation any from approximately washout combined study to Temozolomide necessary window, where start. is due takes X frontline treatment

especially data we've II call. Phase of the of detail enrollment Additionally, program, that delve publication Clinical tailwind observed the during the patient-level will outside Oncology another providing is U.S. the publication into recent which year. awareness of Josh in ONCXXX and the attributes has yet and early response, to This this of additional accelerated this broader of provides Journal deeper

reiterated enrollment interim The our guidance for reflects today data first readout current trends. we XXXX in

continued to wide interim continues beginning first the scenarios are Importantly, as occurs but rate and bars, the and study OS in where the study There rate the still indicators and get understand as the data in to as enrollment of event quickly importance earlier later to also error XXXX year. progress encouraged mature. We're it execution the are early occurs where of possible. while the narrow scenarios by

bars guidance our We'll year. during error the focus continue narrow to come the as into

demand been experienced study in. XX we're by we've operating beyond we've the countries global has currently progressed, the heartened even the As

reminder this patients no a that -- is traveling South to traveling Southeast study. knows from Asia, similar gain States where a For dynamic need the unmet to borders. countries in currently the to are experiencing in ONCXXX. parent we have United also We're example, Southeastern America to patients the between participate access This in population

area this the is demand assessing are process study we attempt high the of ACTION and demand, in an the feasibility convenient ACTION footprint. evaluation. where to to specific number global prudent the expanding to address in catchment limited situation, world of In additional isn't be parts to are the current opening readily every We a the sites. into but can't receptive of We we understand we address of our our intend

significant. For are Argentina, proactive Singapore outreach Kong example, has the Brazil, and geographies Hong among where been

world. to is The process the data, expand within a there high but regulatory high not These will beneficial population the density strategic markets accelerate catchment. time to likelihood only where these will geographies also be and is to around

be excited highly XX in sites markets key sites. the with productive unmet have XX glioma, form top Strong any additional is data a an We in of year and which first-in-class to these represents study be for oncology. of this limited approval priority, across expect as field to position ACTION potentially to we're high any potential to this and next our aggressive to expansion first as high-grade agent the and pivotal the in need potential of execution

of us like Tom time the the I'd accompany that, With November, the joined to to to team to turn Conference. last Tom? Neuro-Oncology Society call Riga, in just over who

Thomas Riga

been it's and be you an to Chimerix. with Thanks, entry It's into great inspiring today. of and fast-paced Mike, all

team thrilled the thanks a to to who SNO stakeholders the the contribute at It's experience in me and was and majority team. a with our day the business Board, commercial Vancouver employees need. I'm company an transition. I company advocacy the in first into of my in the have pleasure or cancer Mike, my the fact, truly patients of of key I virtually development and patient meeting, all to management integral expect Special play Chimerix the help the had open be live, will global joining, patient's to been part investigators, In who other journey. of mission arms. and meeting welcomed solutions the seamless to of operational, bring groups the that Since

From there ACTION fuel are that insights with urgency. study execute those passion our the engagements, to X

have High-grade solutions. need need unmet options mutation is HX and undeniable. have are very new KXXM glioma of medical patients desperate who the the in First, few

high for is patients. ACTION by what an support for level for of there commitment investigators our and their authentic extremely hope ONCXXX mean Second, potentially and an study the could

the rarity are equally who alignment important both the as to awareness journey ensure caregivers network of patient mutation, and given impact the finally, And the to of our study.

patient addition and the neurosurgery, oncology advocacy important In all stakeholders neuropathology, to engage. are radiation to neuro-oncologist,

edge I'm with of efforts Chimerix brand established accelerate and leading starts has a and strong across treatment looking the ecosystem, to development forward helping The beyond. throughout affairs. medical XXXX presence to those

will In States. Dr. both of the addition Pablo be and expanding medical the to Lee, United outside footprint hiring affairs within we our

and strategic across efforts These with enrollment the treatment enhance the will study additions relationships landscape. support further ACTION our our

focus study ACTION with where the clear urgency. is that initial discipline focus to be. is my Operationally, Our execute both and will

also brand will organization look we focus. force quantitative launch ready into for as window commercialization. engagement, message will research, qualitative development, progresses, accelerate payer and comes progress structure year size pricing to throughout Key sales development the and and and XXXX as the our elements As such

help our need. passionate it's will a ACTION gated a of to cost across spend patients the are a of preparation investigators, and base, when committed powerful combined our employee in study. meantime, a will be group the combination effective. neuro-oncology in talented use relationships We guide deepening milestones activity efforts our both with to we closing, aligned to have In and you and all ensure In group timely executing

That that, Chimerix. turn have over the I'll believe call is With I exactly what Josh. at we to

Joshua Allen

This with in mutant Phase in glioma Oncology, Tom, Earlier KXXM activity of II journal Clinical of HX of team. announced monotherapy midline the Journal you, a in Oncology. evaluated and previously the ONCXXX glioma. was the welcome Society this diffuse XX American KXXM efficacy program our Thank HX integrated patients published the of results analysis from to mutant the peer-reviewed ONCXXX recurrent Clinical month,

blinded represented demonstration this setting durable You may rigorously were objective independent responses away the from results that or confounding these of isolated disease by fide review therapies. in bona prior evaluated that and recall concurrent central first

across as rate considering well such that observations RANO is a notable quantitates tail in endpoints tapering up duration well. XX% regions benefit, XX% extended improvement of including was of addition of additional response approximately benefit of performance That rate rate, other as responders concentration Other onset Consistent steroids. the XX% disease considered among of enhancing status were amongst seen non-enhancing response efficacy both range as XX% when while and years criteria survival of examined inclusive forms to RANO as response X-year control was regions. of to that using responders the tumor a clinical clinical and X.X benefit criteria

safety increase accompanied prior further our data patients analysis study. One into that on All goes by aspects this as well in at Phase dosing publication This several the as modifications. is confidence subgroup in rare profile nearly was analyses. patient-level details all dose a favorable frequency. ONCXXX the a include releases of once-weekly That with ACTION of and instances consideration data II received as

So both. the to potential patient frequency into twice ACTION benefit benefit weekly of or or the study the duration of probability has incorporated the enhance

analyses associations movement subgroup performance suggest to status are burden ACTION disease baked design be for includes trial This the setting and expected progression addition, well response as to frontline characteristics. to In acute. inclusion kinetics that less the of were to that the those where in enrich as criteria

mechanism the activity last a suggest focused. with to is year KXXM-mutant KXXM while in a and frontline that publication in where reported agent single mechanism strongly agent core which ONCXXX its ACTION being mutant is HX to these HX cancer on targeted benefit The appears and oncogenic of ONCXXX publication in glioma associated the dual setting addition addresses tolerated. Together, in the a as our in JCO be study discovery, publications well that glioma follows of first-in-class

this to relative its in recent this joins related ONCXXX for of our is The multiple of evaluation I will function disease. compound raising the action. for and medical a journal global prospective to from many of survival that adds analyses, publications to and our affairs our which also initiatives point in out one are outcomes historical for wave emerging patients to favorable this in retrospective dedicated that enthusiasm this controls neuro-oncology as disease awareness

of this expected frequency dose prior to is Turning level, week and we have a been increased to times follows surprises with which be program. milligrams our ONCXXX towards there top Dose therapeutic on dosing. continues per date within the program, XXX the to high At no range. dosing the escalation escalate clinical continue to well at the experience once-weekly of X that

middle dose We safety arise activity preliminary in follow conclusion PK expect of of first is any likely program the adequate of maturity. expected the and after to year, to this after escalation interpretation from data that this an

focused candidate The involve Phase drug that folds solid growing as nervous set evaluation first-in-class well mutation. scope deepening central of ClpP experience with swing. knowledge and within is DRDX of vast tumor do of in the the and full system advanced of this HX evaluation and gained preclinical microtome, our indications the is II ONCXXX. indications outside KXXM The ONCXXX for targets not This the in the data as the of we've translational that empirical on clinical

oral opportunities We continue holds maintaining increased from that dosing for the needs in parent treatment potency to a with and frequency new and that compound from believe features. administration could as safety distinct promise ONCXXX potential a unmet benefit oncology favorable sharply while

a biomarker that xenograft is advanced breast regressions the patient-derived tumors the the observed across ongoing diverse chemorefractory is Breast oncology. tumor in towards precision we in an San these Of one work equal of our was Symposium, many lines, monotherapy collaborators that Along a at last December solid evaluating additional of strong of Cancer cancer. with eye other importance, patient as xenograft efficacy case focus derived Antonio spectrum of are reported

call With to the of now for Michelle? Michelle review a over turn that overview, the financials. I'll

Michelle Laspaluto

We the we today, just the Earlier Josh. the company in fourth year quarter you, the year ending full $XXX containing Thank financial remain during our for fiscal release capital. with XXXX. over a issued of and management in disciplined million XXXX, highly press results

XXXX. our to continue will capital in measured efficient allocation We with and be

of quarter fourth of a $X.XX the million in share or reported of diluted loss $X.XX compared basic or basic XXXX. to and $XX loss company XXXX, a fourth net and the $XX.X the of net quarter diluted per For share per million

administrative same of costs and the for Research decrease during by $XX.X comparable in decreased compared the fourth XXXX. period XXXX. This expenses quarter. compared is period year-on-year million driven with to XXXX associated development related million the essentially and General expenses workforce in $XX.X $X.X the for XXXX million to the reduction for of flat primarily same quarter $X.X the of with divestiture were TEMBEXA of to million the

a burn million of or $XX.X Last just a over $XX million quarter. year, we recorded approximately net

milestones sufficient non-dilutive for We monetizing with continue receive potential royalties into earned to expect our may a and/or capital arising This through disease operations priority TEMBEXA program the with XXXX. support our ONCXXX be this Emergent cash balance year, associated further QX partnership which to additional runway with currently pediatric to with be rare of from potential or should proceeds is voucher, review for eligible it U.S. approval. extended

results. efforts enrollment While commercial of closing over anticipation expand modest readout expect will Mike we continue medical in for increase affair next With III now in year. trial, as turn a we I we interim do ACTION our and in the our back burn call that, data preparations the Phase to

Michael Andriole

we Do maybe to additional Jericho. want with questions? start Any

Operator

Yes.

Raycroft the first with Jefferies. from Maurice line the question of So comes

Maurice Raycroft

ONCXXX in X And you for report just next talk one to with higher more at the the will you that cohorts? enough what escalation. off or dose line, about steps. point conference? that will to have plan a about Can maybe you're where start enrollment top for cohorts expand And medical dose And dose for more one be PK and talk talk about at at you you through midyear? and to can XX going Just Phase safety I

Michael Andriole

the question. Yes. Yes. Thanks, Maury, for

of on dose middle track. we've the heading from we're the level about dose beginning expected So talked by to We there XX year. of X, graduated level previously had part

not are giving play-by-play that we a on we're so in And where exactly continuum.

ongoing, PNOC are different that independently. NIH the X to and are, there studies at Phase be one operating one of And I sure,

and that. we'll medical this rather the will the middle have later a earnings year, arising data be data that upcoming preliminary of we that, part so in And PK expect safety conference, from And at in an likely don't but call year. at delivered

Josh, anything that would summary? to add you

Joshua Allen

it. covers that No,

Maurice Raycroft

XXXX III cycle Phase little overall ACTION order And sides, just enrollment about full you an bit XXX for that. perspective in the readout helpful. reached interim factors now lead readout track for more be you've first XXXX? what need you on provide that more early to any in gating to survival on can to That's Maybe interim Okay. reach the with study, your can a in and talk when

Michael Andriole

early now. to we event Maury, enrollment get probably any need earlier, that than expanded To XXXX, an to Yes. of markets acceleration seeing productivity and/or from we're frequent rates see or more

certainly, has and rate could accelerate that. hitting further couple full consider an are we a and where And good not there's where It's track So accomplish to that. to at see is the enrollment of -- scenarios I on that even potential. what we potential would

there's few So to middle us of that year. the that opposed get a 'XX to could as of part levers part first the

Maurice Raycroft

can due there's Is Is Got or just if it know study? that? any patients more it. to more I provide design? into on perspective don't And you any something on the it getting perspective more seasonality study

Michael Andriole

Demand the is really a or of Yes. whether But all currently, that's strong. we've talked identification a sites to is the as this by reflexibly rare IHC. is sure. almost This -- study, about, it's in be at done NGS mutation mutation almost

the those potential funneling identified the so are our early. And patients pipeline well in into patients study,

visibility months. screening from We're on over patient going through next identification, good that have randomization really potential or and and X throughput really the seeing into good X

more for of not would trend. I causes the there's terms say current in root So

add don't of current know, expectations I for it's, would fact, enrollment Allen, their In you that? anything tracking if anything, rate. ahead to

Allen Melemed

the disease. early patients is long the so can't in able study, they sites, to travel distance of I'll thing that only on The sometimes to aren't Yes. go because add

so wider we we patients are these we will capturing that these centers, patients. and have can Now as capture feel spread a mainly that more referral be we area, a catchment wider

Operator

line comes Wainwright. ahead. Ed from with White of question next Please H.C. Our go

Edward White

just to studies. traveling guess into treating that just additional Mike, any countries follow-up for the asked. these mentioned that borders? or if questions are you a the there's be get that difficulty to I'm follow-up or I patients across just time anticipated cost the are to with were between company the wondering patients traveling

Michael Andriole

a Allen, any question, it's do you preliminary on to good just... want No, comments Ed. make

Allen Melemed

The so And regional covering. are travel can we study actually pay I'll take travel. that. for was that's we that or designed

patients it for for is we depending -- is that or on So covering airfare fare, both hotel travel. bus whatever and are train to

However, of can soon transfer they then actually to countries we so these also care their are be center. their open and most expecting to regional

was the at that the So in study built beginning.

Edward White

Okay. building And bit then, wondering Tom, potentially and strategy? marketing a you're us maybe sales team size need the to if your up little the had of mentioned that just sales give in you you the on can the year. team thoughts on and later more going team of I'm your

Thomas Riga

efficient Yes. see things. much that's I few this Ed, infrastructure, commercial a thanks the and a for and I question. lean think guided very by

the awareness ONCXXX is one, now roughly exceptionally patients X,XXX patients treated. at this think, in unaided States, I are throughout those the specialty high. where know we we The of United prevalence, particular

commercial So infrastructure, done think about could very the be when we infrastructure the we significant asset think the commercial and value is for efficiently.

our level. will especially gated to milestones we use the at commercial So FTE efforts, advance

financial make on capitalize discipline stays sure that want of resources enable to and current think lot to us ONCXXX. potential I we a pivotal timely of the on full sure the data and getting we're to focus in with to both plan, our prudent we that make have our to

Operator

TD next Thome comes Our with the line of question from John Cowen.

Joseph Thome

the you differences, about you Maybe a one, new -- the Joe. do regions my taking there when might these territories? sites, risk first geographic I It's kind to is of questions. criteria guess, just patients Thank different when think potential expanding overall on kind things? handle enough is new of expanding sufficient of care so that a that Or enrollment that, differently the streamline be the for

have of bevacizumab population, And when in does guess, over And study. what of enrollment? the commercial about the sort to like? the overall bevacizumab this is shake then second, for I I have out you that patients a headwind patients aren't allowed portion before do think entering opportunity guess

Michael Andriole

how do you we're that? sites Allen, assessing Thanks. of standards in care about and different to want talk harmonizing

Allen Melemed

picking proper That a definitely Thanks, look ability out do follow-up. proper that Absolutely. picking. the of radiation have the is Mike. proper that the consideration We're neurosurgical we're one and the approach at centers only therapy then the center and to

in population that's As and the that and radiation, this is patient you know, care standard of it. surgery

very sure we to And we can critical follow that, are that we that need that center to whether the want actually we will that care. However, make and these centers a appropriate choose. these have patients qualified use assessment is

know do think have will In Actually these that that. center is regards kind most do we choose patients of come not to concurrent of of there washout not We standard. beva off is don't We on ACTION prior allowed to to the of not that be that Temozolomide, this. patients bevacizumab, allow starting that for off study. a need though we a

Operator

Our question next of comes Soumit Roy with from the Research. Jones line

Soumit Roy

details versus that Thank the progress. you enrollment And you U.S. XX% at on screening the the U.S., the prior mutation? midline seeing fairly or in in are HX from to screening difference question versus One similar? be glioma still versus any regimen of the KXXM they're to treatment Are the seeing data, for ex on enrollment providing you ONCXXX.

Michael Andriole

talk those to any? about Allen, want geographic differences, if you do

Allen Melemed

Yes.

It's difference U.S. a the more outside is population U.S. higher the a the we used Temozolomide used U.S. of the as and little one much main So in more is that utilization frequently the do outside there population the is in pediatric. adult see in not In Temozolomide

this has receive little stopping However, they been therapy. the very radiation there current after concerns about

Soumit Roy

Okay.

screening You the from enrollment seeing person the still about in like rate mutation prior expectations? mutation versus with still is line your are

Allen Melemed

Yes.

of on is seeing are. what expectations So part the -- our what we're

Soumit Roy

of us to year, following next us size be of enrolled, you these baseline be size, data like line full would tumor status? top Okay. some giving co-mutational you would Prior patients characteristics the giving tumor, the enrollment, any

Michael Andriole

Allen?

Allen Melemed

I'm what question? asking here. your following Can you not repeat you're

Soumit Roy

treated be year, characteristics the providing size, after next out the of any tumor details you us mutational patient line on would Prior tumor, the is like come the line being size top data granular announced? data, these Or the top or will status? data size, all to update the

Allen Melemed

Thank you, Soumit.

I think plan how depend this. all that will release on to we

as we'll discuss thing data, would X all to is a double-blind which know, be look data, combined. you be arms could So only that since potentially we study. be And at able this aggregate The would so results. until discuss we have share evaluation that look able share per the we those is be we at something how internally to best actually results. will not But to a arm to

Michael Andriole

Yes. know Allen's we ARM commentary I'd advance at reiterate just that Soumit. won't level, that the in

would so And level data to analyze data, likely that out disclosed it's a it. a full detail chance top is of come following had when we've line

Soumit Roy

Totally question. understand. one And last

ex Would future? U.S. So the any development business much in interest or near the in considering partnership you activities be territories.

Michael Andriole

Tom?

Thomas Riga

Yes.

Thank a great question. So you. it's

as this, and force. at the a and see commercialize we capable in think look for vast are of lean ONCXXX, I with we the efficient to majority we value the ready than more and U.S.,

or reminder, don't ONCXXX, as commercializing South an there have lightly. America, by could Secondly, in we way, geographies, that more are I they're and other it unencumbered. some is challenges partners partner in that very for do But Europe efficiently. be alternate and well And do be especially Europe, there, the Japan may we it take a ONCXXX, China think in whether totally

really, partner allows I to data. some we that we once the But for look to those the that retain commercially as us finding evaluate that pivotal we'll think a But value it that either decision a we to pivotal stand-alone economics geographies. get maximize when what see data we'll or will down come of doing get

Soumit Roy

Congratulations on progress. the

Operator

to there Since the questions turn further are call at over Andriole. time. no back this Mike I'll

Michael Andriole

additional today, joining updates we everyone, Thank look and for quarter. call forward you, next to the

Chimerix (CMRX) 29 Feb 242023 Q4 Earnings call transcript