GTHX - Earnings call transcript Q1 2024

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Operator

Good day, and thank you for standing by. Welcome to the G1 Therapeutics First Quarter 2024 Financial Results. [Operator Instructions] Please be advised that today's conference is being recorded.

I would now like to hand the conference over to your speaker today, Will Roberts. ahead. go Please

William Roberts

Good conference Victor. financial and to welcome and Thank to morning, discuss GX call update. XXXX our the business you, everyone, first results quarter

programs on clinical including our with News the the business and and of of a this patients commercial the period release lung topotecan-containing in The available chemotherapy-induced commercially A morning's was On cell prior small website, or overview an XXXX administered section our financial will cancer. adult follow call, progress approved be prepared that in regimen Q&A can is of remarks. which the our issued COSELA, stage will team for in to press update found to on incidence morning decrease these gXtherapeutics.com. and quarter, regimen when this extensive platinum/etoposide-containing corporate first results myelosuppression session a provide

begin, within and or Such cause those webcast management's to remind risks I of results XXXX. as you statements Before of to uncertainties that in Litigation and from Act involve actual differ today's implied Securities today, of meaning expressed Private by the statements. these judgment materially that want Reform we statements may represent forward-looking could contains the

on views represent with XXXX. SEC risks or statements our today, For the more on which forward-looking information refer available of filings please our the from such website. May Securities and Commission, to our uncertainties, are and Exchange as corporate X, Any

Malik, Chief Medical and Jack Joining Dr. our Chief Commercial Executive Chief me our Officer; Officer; Bailey, Raj Perry, are our Chief Financial today Umstead, call Andrew Officer; John Officer. on the our

to the Jack. call over I'll now turn Jack?

John Bailey

joining the and morning, thank today. you everyone, Good Will. us on for call Thanks,

COSELA. commercial perspective, for on identify a opportunities execute we From growth and to continue

sales But Andrew, will fourth $XX the challenges over million. to vial trend, shortly. due actions the to will volume in of guidance was of of you more from hear quarter speak impact the of some that net we've the recent and in the he sales $XX confident as million remain XXXX quarter we result a taken As growth XXXX our X% our to

indication are of small profitability later we We expect our to cancer, next internal stage its positivity lung cell continue first usage expanding to assuming extensive drive and to COSELA flow in in and committed achieve to year. forecast, cash GX

X readouts you'll and breast across hear leadership as triple-negative remain over on Raj, of the regard, opportunity Now from in coming also for cancer we the months. data focused important spectrum upcoming forward to that the look category

shown we've improvements in govitecan, our First, promising XX-month combined survival. with median the sacituzumab overall meaningful results, trial, thus ongoing is trilacicilib in and ADC far, II Phase when including

XXXX As poster in ASCO excited the you we updated results at to early saw a June. this provide morning, are in

results the ongoing be if would a in III setting our aggressive people amongst across the trial the first-line final generated this compelling are for Next, disease. PRESERVE status extremely and significant with PD-LX metastatic they Phase X positive, from of data data living most set trilacicilib

regarding FDA the this inclusion results patients expected year. in these the with interactions enrolled the in Ukraine, recent of upon now quarter events based discuss, late will second of Raj As from are

exclusive Through to early-stage this transomics company pathway CDKX/X to their complement saw data gains today, for those out-licensed early-stage manufacture Pepper an radio-protected carcinoma release all clinical Pepper lerociclib platform. a develop, Lerociclib They've uses. our proprietary through Pac asset their key transaction, hepatocellular certain in we've pipeline. the discovery for lead the will now rights as in Bio for except rights you their as press areas indications, Asia be identified stage and Finally, to commercialize to earlier global excluding region, called lerociclib, Bio.

will expectations, provide of the cash along of the expense of the associated John Raj an provide commercial then with results and our you will financials the TNBC financial Andrew Bio trials ongoing call, each. today's the the will revenue, on from remind a for timing Pepper and transaction. our with On review status data efforts. including recent provide update of our quarter,

Finally, I'll some concluding be for back comments.

I'll that, call to over Andrew. With the turn

Andrew Perry

where Thank opportunity in going I'm significant performance, you, commercial to business. of was John. update you our a headway XXXX this which first parts take on to our quarter made quarter we

areas, also other faced we short-term in some Although challenges.

full regional quarter-over-quarter segment were with our build help growth, XXXX And will quarter. on deliver of in executed actions we to which to digits goals. us goal executional in to opportunities, have in Our by grew, the volume the successful and set to We double-digit address largely quarter, driven been which variances, some while if QX areas. within closer which took delivered double headwinds, vial had should QX some objectives several better and year growth was vial this it strong we in our we up these

in maximum small reminder, lung cancer, duration extensive-stage As of a XX the than less is first-line chemotherapy cell days.

patient our existing then to quarter, depth, in growth So accounts relies breadth a creating every order building grow. additional on and base quarterly new and newer with

attributable volume. Beginning volume QX to X low XXXX. ended overall with The with compared growth sales We vial QX factors. growth X% with was

over few continuing January, number through holiday First, which new of we ] patients into of the quarter. period the added the then [ impacted X December patients

our slow These expect the with first would their a the orders Southeast. several below we typically of of have X/X were part customers we large customers, the primarily in levels Secondly, volume, the comprise and quarter. start in

Thirdly, contracted our X of below customer performed networks expectations.

we actions will the I case, executional each address In the gaps. took to outline

new representatives January. at deployed we beginning the sales of Firstly, X

high-potential with contracted advertising digital significant the the increased customers geographies, on digital including the well as push, driving as Secondly, in display Southeast, a field focused invested existing ads and with campaign affiliated prescribers accounts. we and with COSELA in debt

sales management growth. any the with slowing the in educational customers Thirdly, or to could large at we which gaps, met our be Southeast operational senior address

X been immediately growing in has which significantly existing enhanced in including several successful of new executed we X network volume. Finally, contracts February, and contracts, our community

slow comprises X our in around which the the Southeast our A territories in X quarter. of region in West of the to start region, West grew the almost offset by X/X XX% XX% in year was than more growth volume.

result West in the of region, focused we this a continues headcount As opportunity. additional market, our represent on an enormous success, which Texas added to an

grew double-digit health saw covered also XX% by extensive pharmacy comprise growth the experience. which expanded during over now overall oncology of function, customers Those accounts roughly XX% We in combines volume. knowledge our the with strategic quarter of specialist and systems customers our

systematic team set mix, their we QX, additional customers where can to adoption. an accelerate of Going into added believe we this

which meaning the organizations, the volume another XXX opportunity top of top top represent added around during in customer April, new we customers half the in X the XX and on XXX QX market, Focusing X customers have number QX, XX date. XXX ordered of launched top a customers the launch. COSELA order up top quarter ordered XXX XX in XXX which since highest during in to QX, from to jumped

stayed business, few at added similar Our Across business in we new accounts XX to the similar our to QX in proportion last over of XXX total, quarters. XX%. top which is

share remains demonstrating estimate the remains growth. XX% opportunity there significant COSELA in around Our for first-line that market, of patient

has both to and growth And March, month We are business quarter-to-date. launched double in date. return sales QX. slow large for in over back volume to customers stronger our into also has digits and started QX in saw growth our quarter-to-date. at The been the ex-factory April a Moving growing XX% to contracted Southeast highest in is

target. quarter, during with With top the now the I'll X and XXX actions XXXs our we COSELA call revenue XX taken, more than the the using continued top and in to for we're have new growth first product pass time, guided Raj. confident

Rajesh Malik

and of and expectations results. good morning, our Andrew, the timing Today, I the will of Thanks, status clinical everyone. for ongoing trials our provide

result Phase is X and gemcitabine at last ratio mentioned trial, with for the hazard our we our PRESERVE For III the call, analysis final as boundary carboplatin, X.XX. on combination our in positive

reminder, hazard ratio intent-to-treat and population X.XX. pembrolizumab FDA-approved the PD-LX the KEYNOTE-XXX of or a positive was And was for the population As the X.XX. ITT arm

biggest result breast cancer. positive to metastatic mark would PRESERVE date in first-line triple-negative a in overall So X in survival the improvement

recently from we that enrolled the analysis ITT which survival analysis in from overall reached this population, rather Regarding recommending Ukraine the feedback to FDA be should our the the the patients trial, have February would ITT we events. with population includes for were received events that survival conducted in final that these Subsequent methodology financial agreement results modified call, the excluded statistical incorporating the them. FDA than on the the

that the second As to amended the analysis quarter a the we changes, conducted final for we expect the of now survival overall will these XXXX. at of result, end protocol be and account have

a positive, We the presentation press look later robust in top-line and a more via of release forward will if XXXX. at results medical meeting announce results to

NDA for thereafter. will meet we and we overall as to as filing achieve the possible soon plans the the endpoint, supplemental results our discuss survival Assuming with FDA a

combination Conjugate, been for TROPX the Next, early regarding results June. our Antibody that to a happy Phase have II trial trilacicilib, in with presentation sacituzumab, updated poster Drug this ASCO accepted in the announce morning at we're of

historical alone, promising overall these patients reminder, results combination ADC survival ASCO. survival to initial the meaningful and median described January, among with and in update As at for compared in we a including to are data, initial excited sacituzumab we XX-month receiving improvements in results trilacicilib

be We us, trials survival Our breast with believe approximately median over such with partnerships trial and improvement into X overall result in to triple-negative combination a this cancer in companies development would of successful beyond. or ADCs TROPX of move interest results developing towards to more be months would measure in a that sacituzumab. historical pursuing pivotal

trilacicilib, such be designing treated types with breast plus analyses, would in readouts to interested these trials which ADC patients, future inhibitors exploratory helpful very in triple-negative from in category as ASCO also We the clinical be leadership included forward inhibitors. are enable efficacy positive We could both those results CDKX/X us look in subsets will to prior as of results, build of trials combinations. in cancer. TROPX various of checkpoint exploring These or

results. turn that, an financial With I'll John John? on call for update our over the to

John Umstead

morning, good Raj, Thanks, everyone. and

sales were and the are in the quarter file As first for we $XX.X quarter first XXXX, expect press in XX-Q, an of XX%. financial of increase net COSELA $XX.X to the sales compares quarter million first to the This COSELA results in million which Will be of XXXX. of representing XXXX market of of in favorably full available morning's close. after this mentioned, for Net release will

for million, quarter the revenue total of of XXXX million $XX.X quarter which the XXXX. Our to $XX.X compares was favorably in first first

XXXX completed total $X.X previously the Our first in in XXXX. sold due million development $XX.X compared XXXX, in the research following: to $X.X in expenses the of down million same for in for million goods the for of million studies. $XX.X XXXX. million to $XX.X and of period cost comprised to to compared were was in period quarter operating the continued $X.X wind compared same of primarily period change million expenses This same

$XX.X And commercialization compared lastly, of the administrative The million million expense affairs in due activities. decrease in period primarily continued medical our and to and $XX.X in general costs SG&A to personnel decreases was in expenses and selling, XXXX. optimization same for

of million cash debt million ended that during cash of base quarter first revenue. $XX.X limit Regarding million our with paydown the of compared we an is X-month balance million $XX.X facility this to our to the cash XX, of cash, due to It marketable our $XX.X XXXX. tied and the securities $X.X December position, to borrowing reflects trailing equivalents quarter important note current as

will However, this million. we principal, realize savings interest by cash $X reducing of year our almost

further do we of paydowns approximately in cash quarter. projections, revenue anticipate Absent our not the for current any this until operational required paydown, year. our begin December $X principal totaled having burn million on this payments Based

and XXXX. guidance our runway for regarding expense cash Next, revenue,

of in half on sales receiving XXXX a in following of is approval guidance As commercial sales previously We lerociclib anticipate their XXXX we of from would receiving China. in in milestone If million our to Genor begin XXXX. the million for $X There payment gross and we to the territory. royalties expense between $XX change approved, lerociclib percentage back $XX net stated, our revenue net of million remain confident estimates. no

than while by be spend, to reductions, XX% driven invest our reduced XXXX, is that Regarding XX% the cost following expect structure continued optimization This of commercial R&D lower headcount addition we expenses in to to currently expenses of to continuing for in organization. previously XXXX. operating targeted

runway any million. We the will $XX on balance include cash the revenue. runway and expect that to cash, of into cash marketable million the This cash we filing includes range but not XXXX launch-related securities to TNBC-associated and the continue year-end equivalents of anticipated costs, $XX quarter based TNBC foregoing, us does in XXXX. third And expect take our

we months, that GX Pac receive to we call upon upfront million earlier commercial Genor. previously expects out-licensed milestones. within XX excluding in mentioned which receive mid-single-digit to Jack achievement Finally, Asia millions Bio, $XXX have up eligible and are the development lerociclib certain the to payments of to out-licensed Pepper to and countries, of

receive aggregate In we annual royalty sales a net addition, of will double-digit on lerociclib.

With Jack that, to back some comments. for call over turn the I'll Jack? closing

John Bailey

Andrew Raj, cancer John, always, And to also recognize you, and Thank want as the community. I Will.

be opportunity We a part your are thankful the journey. to for of

from from acceptance large in by and focus results the customers cancer. Southeast of must to our continued of the you ordering execute TNBC functions. are immediate leadership slower-than-expected on heard our on XXX after and could in growing build encouraged return April trials first upcoming as corporate we Andrew, a indication, our expected accounts, that its ongoing the triple-negative impact strategic the some Now accounts by category first But team COSELA clinical the in breast our the in stay a positive to in product quarter growth commercial patterns top our while continues

addition or development to that believe into the Phase TROPX forward of ADC ASCO II and We X improvement the trilaciclib striking sacituzumab approximately June. overall of to allow pursue an To trial the that presenting months end, trials. combination of partnerships in our from in with move to would be survival to more, we of us success at would the pivotal mature combination TROPX ADC, trilacicilib, survival that look and due trilacicilib results ADCs in to a

from III PRESERVE cancer triple-negative quarter Phase second of our in breast this trial results we towards ongoing sNDA. positive, filing of year. X Furthermore, the final If first-line quickly we in expect move late would an

this morning. your Thank you time for

upcoming format of speak, the see August, quarter on our at again, in non-fill or many this on ASCO you roadshows. We XXXX and will second in call we'll

would Q&A. our close and Operator, to turn that, to the please call you With how I'll it remind listeners over question. a ask

Operator

question Gil Needham. first Our comes from of the line Instructions] [Operator Blum from

Gil Blum

seasonality quick Maybe see and holidays you here. the affected on to the remarks that aspect how starting on [indiscernible]. the kind regarding patients. Would I'm on a of that level commercial one we're focusing say of the some

Andrew Perry

to us on claims February, that. patients. issue takes immediately a act a Thanks, the and not we're Gil. would I we of say diagnose to in No, We new see drop It around couple data months when that in able obviously diagnose it.

reason is any continue is QX of any this quarter. course, This seen, a about which there's to seasonality though, also that think to in Strategic was in some West in segments our don't execute, issue. What have I country business we think every in ability great that, the way, our of and during sector we our some our well, quarter. enhancements the to have to in and in of actually business, improve our academic our execution Defense as during business and including which grew some parts

I your yes, So that hope question. answers

Gil Blum

cancer readout? you on level think study, details those study going successful? the in include It breast that triple-negative to does. And the That details the and helpful. will what depend you're as to of the very disclosure for And readout is was whether do

Rajesh Malik

here. Raj Yes. Gil,

for So release, of the sense get we a of plan We the a this presenting what always to in press the have the results at to conference. set community full investment include with balance medical were. data enough really to

some subsets, obviously, be comments should types of disclosure. degree some comments, fulsome those but of it improvement on the in survival, important obviously, overall So safety, a

Operator

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

Joseph Thome

ITT And just idea Maybe patients X of like data can give of with drug whether MITT Ukrainian inclusion there were or Were sites? kind what the the of one other from us of the Ukrainian study. the to Maybe patients the anything advocating getting or or the in TNBC an patients do around issues you or population? quality any was the way company that? proportion

Rajesh Malik

Joe, patients so enrolled XX were that Ukraine. there in were

patients. that from events proposed So obviously, have recommended would the ITT and patients. initially we agency include events excluded from these population, we had the these patients the modified these which The

to And back are that's and really of line. and of that, there forth resulted in do do approaches a how what discussion our to time because variety so was it on kind the that

we're terms the We of results. remain in blinded the -- obviously to data. But in confident

small of So it XX XXX. number relatively out a patients, was of

feel of So we data. the confident yes,

Joseph Thome

with just I and the there. partnership And hit forward path and maybe Great. combination know the positive then one data indicated on benchmark. of Trodelvy that potential some the if X-month of sort you interest, are kind

path toward move you that? of there are in without a you a terms is where combination a III? to partner discussions? for And a you about How to Maybe Or are partnership partner? thinking would Phase forward need potential

John Bailey

I Thanks, companies a on Yes, this. Joe. out mean, lot prioritizing really of Jack. I Yes. partnership a, just This TROPX multiple there, companies. there's think we're is ADC

for So we've data A folks had of to come or discussions waiting out. lot are anticipating ongoing. that

So that development partnership able capital is at to do that. path is preferred a our to point, to this be look for

Operator

Our is the next Rama JPMorgan. from of from Anupam line question

Priyanka Grover

for question. just Priyanka quick on is one Anupam. I have This

think of the you the COSELA. between who there commonalities those it in would any not accounts top those How that can was tackle that are using COSELA? using I And mentioned target? call XX you are XXX are

Andrew Perry

XXX so trialed our call. actually, we of Thanks, last date, launched since have added Priyanka. X the to and COSELA Yes, top XX

of quarter. That to So add QX. in XX that to during significantly continued to number actually, XXX up ordered XX we've the had are actually jumped the In trialing. top QX, the

we've So the quarters. seen really that's off quite actually in a biggest that few jump

we the improvements able in real trial add We compile the obviously, over year systematic to medical helpful to top time. to XXXs those on the is been last XXX continuing like in front. And from world ASCO utilization growth, as moving are to saw things are that adoption. evidence guideline to obviously top continue and secret we've do the So build depth

to So headway to the driver continue we them and future. growth top look as to forward success reporting going see we the XXX, continue make in a forward, and in we

Operator

question James. come from from the next Our line Laura of Raymond Prendergast

Laura Prendergast

two quick for Just ones me.

to as time in patient trial based versus to what First, Just first-line overall beyond guys chemotherapy the on hit get thinking of is on off X study? PRESERVE far you if are a X what expected cancer? be expect cancer, you breast how this? do are then have in the the treatment for And survival, lung PRESERVE first-line triple-negative seeing guys as approval you the does about been able

Rajesh Malik

TNBC Phase III terms can't in it's because obviously, our just the ongoing. comment so Laura, of on I first-line still

However, number the the you II the if you patients when Trila alone. cumulative XX% is cycles to about refer compared dose around to to study, back -- [ number Phase median total at look cycles of on But X. it's received of chemo, chemotherapy of ] the greater XX% if

terms obviously, But a to span question with will first-line was, which regards -- is second potentially get carboplatin that the data get and to we approval we discussion in of beyond be first-line the an with our matter approach going and to agency. beyond. broad And related as course, discussion This of will of So could possible try be a as always gemcitabine your of to indication the could, combinations, matter the have and once indication? approval statement. be

Operator

Nierengarten comes question from line of Wedbush. Our next from the David

David Nierengarten

because or events it that follow-up a more guess robust time moving occurred agencies analysis it seem the statistical from up from would if in in include And this Maybe patients. preferred I them provide a that asked I'm because population. would to Ukrainian answer? wondering have on line the I aid the

wrong. they So unless contribute, I'm would

that's question. So the

Rajesh Malik

yes. Yes, David,

in occurred the have when little and a the at time those why second patients, moved We blinded. up We're don't those events, count line that quarter. obviously you the actually in. those know the reason arm end which is occurred events of events So bit

this think deal good question is I And is how patients, And enrolled of there. no guidance Ukraine. terms open in really with who an really in to out are there

starting the something out. put the from agencies or FDA European to In were fact,

So I of the think been board. over it's sort all

proposal our to what is the all forward. wants put which we include we're So clearly doing. data, And agency the

landed. we where that's yes, So

Operator

H.C. come Our line Wainright. the next ] [ question Stephen of from from Bersey

Unknown Analyst

This the lerociclib is on Ed deal. on Steve White. Congratulations for

So and are be the milestone indication? we're per just what timing payments going onetime are payments wondering then to also triggers then whether the the payments? And on those? they And

John Bailey

Yes. Thanks, Stephen.

about the excited certainly we're It the patients. lerociclib opportunity too. gives benefit to deal, So obviously

take part. didn't your I So first

of In development, both terms they're regulatory. of the milestone, a combination

So those time. unfold over will

was? Your first of your part question

Unknown Analyst

the indications, go payments be you per indications So to different are into? that going

John Bailey

Yes. There upon can be multiple based multiple indications. payments

Operator

Tash Hasan Renshaw. [Operator comes Instructions] and from from of Our question next the Rodman line

Unknown Analyst

Tony efforts have to sales think the on thoughts force. is headcounts the this Butler. I This heard new commercial how help X of your about you the I another Tash And in correctly, could wonder current the is addition if If Andrew I question. with spoke Hasan for expected then share setting? I about in

Andrew Perry

Sure. always them, that. in Thank capitalize -- sales our on to and structure you and identify looking be for We force able headcount mentioned to I the and to a West. also are were size at are new the effort that question. opportunities we added do these changes

exactly do key we've identified. In well as of of to take opportunities on key access the to some advantage success relies situations, pharmacy sales COSELA many to staff. nursing decision-makers, gaining representatives example, the as and prescribers For of that

that, access arise team, accounts sales medical our any so role that combination team our our then team, affairs valuable market with strategic questions a including And through in and doing our with performed team. answering

our respects, our to the into many of absolutely our is new force continued success, welcome in organization. sales delighted we and folks So those evolution critical to were

Unknown Analyst

helpful. That's

question is setting. beyond other cell the small lung cancer patients The about frontline

second you assuming us is share and third whether COSELA For assortment having example, also frontline after number And and there being significant a of can in the received it of markets? setting? in any, with second-line share dosed the line patients the that see you with your data,

Andrew Perry

that. give Sure. of can I Yes. you outline an

our use indication today rechallenged there's About in who well Within is XX%, that patients setting. with is part of the second-line in XX% plus. as So about as are etoposide/platinum. XX% first-line our topotecan is patients, of which

around or -- market market overall our first-line is share XX%. share Our

not not different second-line that. And overall different both in in patients eligible setting share too the on either, simply share double market our is second-line from that is setting. the digits, from Our too the

in So our share huge and use. there's difference first second-line market no across

Our is patients. because represents of use first-line that focus mainly majority the

Operator

over remarks. the like turn it And in with I'd for to queue, Bailey, no Jack to further CEO, closing questions any back

John Bailey

operator. you, Thank

forward Certainly, on As today. everybody you joining our to look keeping progress. We'll thank updated touch. we always, for us in be

Operator

Thank conference. your today's conclude participation program. you for This in the does

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

G1 Therapeutics (GTHX) 1 May 242024 Q1 Earnings call transcript