Earnings call transcript Q2 2023

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Operator

Good day, and thank you for standing by. Welcome to the G1 Second Quarter Financial Results Conference Call. [Operator Instructions].

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

William Roberts

Jade. you, Thank and discuss everyone, business the conference GX Good second welcome quarter to our and XXXX call morning, to financial update. results this found release results GXtherapeutics.com. of press these morning website, issued and The our corporate can the in on be News section was financial

available and the on in mornings' this approved our which and commercial progress or of clinical period decrease team of chemotherapy-induced cell with XXXX, is in a for to business will programs remarks. A On quarter incidence provide including that COSELA, the overview call, the myelosuppression second prepared commercially to small the ES-SCLC. adult of prior administered an update question-and-answer a our patients follow session lung extensive-stage topotecan-containing with cancer or platinum/etoposide-containing will regimen regimen

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

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

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

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

John Bailey

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

for goals midyear, of our remain XXXX unchanged. As

cell amongst stage COSELA XXX usage First, half who cancer country. in top to the the small patients of organizations all drive and adoption, treat of especially extensive lung depth

and Second, for early runway. cash clinical to year; to next important manage finally, efficiently our readouts prepare

in depth, customer drive continue drive particularly volume the broadening top XXX. goal, deeply the of adopting to first was our objective organizations quarter-over-quarter number Regarding to COSELA our and by growth amongst

seeking As million a $XX.X in did platinum-based net in guidance shortage. Andrew, $XX while chemotherapy to million, this navigate to to net to you'll in quarter X% COSELA XXXX. headwind, us sales recent $XX enabling from national our successfully reiterate quarter-over-quarter grew that of hear million we sales the most Despite

next result COSELA platinum Though the flow we as we our investors toward It's positivity internal a reminding of potentially lower to in of that to will us end continue be years. shortage, drive cash our the we and few to worth expect assuming forecast, that hit the range. profitability

this presented tolerability can time a goal, the trilaciclib throughout II GX. trials, Phase that improve exciting second particularly for data including We of an the the is from Regarding important quarter new our ADC.

results survival II from well in shortly of TNBC are from supplemental first the potential discuss positive, results we Phase expect a If quarter XXXX. trial III the breast two our triple-negative to after cancer as the as NDA FDA pivotal filing interim meet we with that. Importantly, to Phase the trials III expect Phase

strategically progress quarter our made during good we in finances. Finally, the managing

and of flexibility. Mainland of portion down amending relief the debt payments for future in obtaining sales provide our Simcere by First, royalty additional to of paying a then agreement from debt COSELA China and Hercules payment financial on with our by

pipeline, provide quarter. Now financial the for provide our we and efforts will topics Raj clinical recent discuss cover results. on each and commercial an Andrew our will update of John in then order. these will will results

over some to comments. Andrew. Finally, that, turn I'll With now be the back for call concluding I'll

Andrew Perry

commercial we've months be to sales made today glad I'm over to on update provide Jack. in recent external facing the with challenges. you, you execution our some and performance, our XXXX second despite an progress Thank quarter

customer a and second in of in by broader marketplace to We factors organizations. growth challenges, on build despite quarter-over-quarter delivered continued discuss to QX, the and in we've deeply to deliver continuing today. adopting QX, our our the extend performance I'll goal some some this more quarter was goal platform Our of underlying

results. sales with Beginning

As representing X% million sales net $XX.X fluctuate that patients. X% small quarter sales in of growth Jack market with for previously of cancer and our the X- COSELA, in volume mentioned, the with vial growth We've first-line to lung duration the QX. X-month growth cell due extensive we therapy stage ended stated compared can to

both which this chemotherapy in also the quarter, interruptions incurred faced and backbone or patients are national of considerable cell carboplatin well-publicized disruption we of challenge with small lung switches cisplatin, However, the in as of customers This those discontinuations caused shortages platinum-based and regimens. cancer. and

flux, in in the anticipate improved year. remains second situation the of an the outlook Although we half

our business, of COSELA less May in terms may impacted on stock June particularly performance estimate and the and hospitals, effect clinics and carboplatin that our which had community capacity maintain this we In of to cisplatin. have and

stage small the more shortages cell in customers XX% example, than XXX may non-top nationally, half cancer by around larger been in For being see COSELA and quarter to platinum volume lung extensive due customers, top affected XXX declined of XX%, grew this which while have customers.

may when We purchasing the XX% in market maintain to at who due all saw institution academic in customers the and for to minus community quarter, their And again, with grew customers. ability similar looking all be X% power stock. this compared dichotomy

shortage, performance have of growth rate underlying actual anticipate some we without XX% than volume trends, to our are QX that QX closer these been the platinum growth of X% Taking in the of today. into growth reporting our account may we

stronger deep we customers also saw XXX did we the of the only growth build earlier, referenced during of business we number but a customers. Not deep increased COSELA quarter. institutions the in are Despite of in academic our top see saw challenges, indicators and number an adoption adopting a that to continued base

was XXX organization, customers XXXX In and new from XXX quarter, than top quarter in QX organizations, of the XX top COSELA more up vials. customer XX than more second the in have purchasing last XX organizations X Last quarter. which board purchased highlighted XX quarter, in launched in of meaning customers vials QX on XXX I increase XX orders from an to from ordered saw the date. per brought We XXXX we top accounts, to XXX new including XXX XX QX,

challenges and education elected the the optimal community the option. continue Xx volume-based with place compared support COSELA as customers contract agreements. through a who to through of who position placements , care COSELA EMR we QX around customers of left oncology to utilization in simply an default standard community Despite debt In demonstrated on as their XXXX,

XX% we a added We X community roughly estimate of business is with agreement. new in QX, who and have our customers volume contract customers

the share represents And share claims we although volume QX in We of for grow. of academic the in our from volume assistance majority are come commercial centers, X% our use. volume of the was XX% COSELA saw range patient not fully supply through patient quarter community continues program. XX% in data first-line of estimate our available, with of which the the provided XX% to and in in market, XX% Our clinics and quarter estimate patient hospitals, through

Moving on to QX.

academic to rates begin at there platinum growth We see that shortages we've customers normal and the affected in most by community remains segment. shown to the more potential reorder have been encouraged

last We quarters over continue shifts we've marketplace to the challenges. the made despite see the several of strategic benefits

our As for ambitions to always, our commercial evolve COSELA. we'll model continue to as achieve necessary

pipeline to I'll over the Raj update. a now for turn call

Rajesh Malik

cancer Thanks, progress colorectal expected the our recent results overall understand ongoing results, pipeline, work Andrew, update time results. good to provide an for trials will and with from III review Phase lines I clinical survival everyone. the including morning, our and the on

First focus and foremost, based development date on to plan and paths on to primarily X core data the for optimize trilaciclib. to we generated ahead, opportunity

steps The and metastatic first in secondly, the a arms additional in any. a settings, trial, types. data this if in determine setting, let in to bladder already in Phase trilaciclib cancer II ADC combinations, we survival where tumor TNBC We in shown survival the have advantage including next

now showing clinical sacituzumab of have sacituzumab. review profile adverse compared prior changed start and anemia we diarrhea. with associated ADC, neutropenia, to ADCs improve results trilaciclib presented in the the during quarter. with will landscape. combination data ESMO convincing was presentation sacituzumab Gilead's I'll treatment meaningful And govitecan. of safety the over May single-agent we reductions the tolerability to thus of Trilaciclib of multiple the that with clinically far, including second of events XX% breast rates our have the trilaciclib can administered ADC I in

and are We the June, cells we on associated survival to with clinical function help will to measures by new II may of and as expected believe surveillance quarter and having may immune long-term overall be generation which a memory that the consistent patients in action enhance other live immune results ASCO Then that increasing immunotherapies. a to showing looking This presented overall forward expression of and efficacy with treatment marrow from cell we're at T ability rate certain bone mechanism effect with our Phase of such first healthier trial XXXX. earlier overall greater in PFS, of system T results, survival response produce be trilaciclib And to profiles improved outcome. the expected compared trilaciclib longer. function gene

expect alone. of of participants XXXX. of a pivotal care, the overall analysis arms III first interim our we to in to first-line quarter survival prior continue advantage survival II of statistically replicates to receiving overall This care largely regarding will trial, that in TNBC occur showed Next, significant the Phase the the for Phase trial that standard both standard compared design trial trilaciclib

analysis the results. the and the reminder, will trial meets a it interim rule, report GX As top stopping if will line unblinded be

NDA it as meet possible analysis meet with stopping analysis. supplemental If interim In continue the we to will does will to addition, quickly trial discuss a rule, in as final the filing potential XXXX. FDA not the

bladder study. II Phase cancer our to Turning

overall combination. data meaningful most rate the trilaciclib avelumab patients the who early prior the to rate in patients received January survival the evaluate as come. Despite response We most differences trilaciclib the early next announced our this who that expect anticipated bladder favored numerically received the cancer In would setting. press of to gemcitabine/platinum response recent that release, we be in and over in trial, results data year

overall the similar median trilaciclib with tumor was The in arm median months control X.XX. arms is arm subsets. the months hazard with ratio of the months Median PD-LX trilaciclib Further, across X response both X both arms X PD-LX in PFS between X.X versus months and of similar of with subsets. a tumor in duration the and in PFS favored X a

determine for trial of in We OS will reach type studies XXXX, which quarter warranted. the in expect final first to this are the whether tumor additional late-stage endpoint this

on III involved of X-FU in want an uptake hypotheses, colorectal to tumor. work cancer I the including effect an number provide results. of the a update into We trial understand transporters dependency our of to explored confounding inhibition Next, Phase of potential CDKX/X the tumor,

specific any the specific unexpected our or all identify clinical not did to of are results this efforts our cause factors we analyses, data specific from CRC and comprehensive believe Following trials, likely results. this tumor Considering type. explaining the that regimen attributable

seen similar outcomes in not small cell adverse extensive We antitumor have triple-negative any studies in efficacy breast cancer. stage lung cancer or our

fact, TNBC. saw improved in we In survival

making bone system could protecting In such regard, in readouts efficacy events, first data earlier, XXXX. the improve said marrow I As meaningful our the of across that better we and to quarter tumor overall survival. long-term trials based the of on look outcomes forward OS immune as function occurrence the

over the financial turn John results. I'll for the John? call to

John Umstead

everyone. Thanks, morning, good Raj, and

expect financial full market we release to and are after XX-Q, quarter available As second be in the the morning's in press close. Will today file mentioned, will this which XXXX results for

total the million of million, quarter and Our revenue net license XXXX million. of $XX.X COSELA $XX.X revenue of of revenue $XX.X comprised was for second

For $XX.X the total in of was including net million $X.X XXXX, same revenue. revenue product million, period

is cell services supply manufacturing related quarter payments relief remaining license reimbursements the Simcere from for with clinical Simcere and stage The license current lung related sales cancer Mainland revenue primarily of China. to for royalty EQRx. Simcere trial revenue small the in to and extensive future from The in and

Medicines. formal back revert the rights of to of EQRx, we as the by yesterday, and acquisition the product lerociclib On their us proposed received agreement their of terminate notice Revolution part topic license intent to

expect assessing currently them. additional and from steps are would to payments milestone receive next not We any

We the expenses XXXX. be goods June the ended XXXX. for to our XX% we of in Cost sold that on XXXX of lower for that million mentioned same compared to expected X operating $X call than XX, XX% XXXX, was months to last million $X.X the period

XXXX. we update, XXXX expenses lower operating expect an of than XX% to be to closer As that now our

compared development XXXX. and XXXX quarter research of $XX.X million Our second expenses second quarter to the million $XX for for the of were

This million personnel $XX.X to Our expenses is and for reduction commercialization professional the $XX.X of decreases expenses of Selling, in associated fees. for second costs compared second General quarter activities, and with the XXXX. quarter XXXX to primarily Administrative were million related

our quarter $XXX.X cash, of liquid XX, cash XXXX. December position, $XXX.X compared with as Regarding and we ended equivalents the of second to securities million cash million

as topic While sheet financial strengthened of we during the flexibility on even our further balance our and Jack cash the position, added mentioned, quarter.

First, royalty payments Chinese we after $XX lung for small stage from the extensive Simcere of withholdings for of million net proceeds received future indication. relief cancer cell

receive our the we positive an Phase NDA X, of data their $XX on of from additional Then would on and million, amended on our million agreement $X Capital. approval. pivotal ongoing trial, potential filing Hercules to GX pending has million with III which China XXXX, an $XX we receive some in Mainland loan TNBC June

and tranche modified certain amendment minimum advances lowered covenant. cash required the The

base revenue amendment, closing minimum down outstanding loan loan the limit. borrowing of now In addition, a for paid conditional covenant of resulting GX June as total XX, the and in amount the existing a $XX XXXX. the $XX million Upon provides of amendment removed million,

runway Our of into end of of clinical our financial and have that cash readouts Raj discussed. the June additional is position cash beyond takes XXXX well flexibility the trials reflective those we transactions. our of we as result, as a believe And strategic

a and and $XX product be to of we a we percentage year-end chemotherapy for runway regarding lower range to $XX and no Finally, on equivalents of estimates. our the of and million end $XX anticipate the million, platinum-based foregoing, balance because guidance XXXX million. is approximately net to revenue cash million though the cash our range. we $XX There securities XXXX that of for guidance on cash, XXXX based reiterated shortage, And between revenue may change expense marketable gross net

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

John Bailey

the Raj, harmful disease. difference in In thank living clear the Will. benefit Thank And the are the making confident the as our first effects small rate John, people continued And cell living people cancer, heard lung of to lung drug makes inspiration. I protect in of the due and in know its patient to potential and small want ability indication, from the cancer always, for of cancer Andrew, marrow and cell we this your you, Andrew, chemotherapy. you just We remain with bone adoption. our to to from strides expanding depth is as COSELA with

that phase a Importantly, of we accomplished this business in our in the quarter. the shortage platinum-based second chemotherapy impacted

making we are potential that line, better. has immune improve convinced protecting sales system the to meaningfully the by Beyond trilaciclib efficacy bone the marrow function and

to soon for in trials. from lot is from first prepare we If NDA await We data survival our II a have III pivotal of year there, -- trial to TNBC forward in step possible. II Phase next Phase filing to quarter as our and in a next regard supplemental the as successful look that as

drug have with first one are position the companies years, that an market cash I'll next expected a results. expected that in in approved pivotal cap benefit and and few in the is of reminder to finish few sector profitability our provides and get those that to other along drive data we the us quarter the in through XXXX with of very clear

Thank you morning. this time for your

We will this on investor conferences. speak at see you quarter many the again in third November, in and call XXXX of fall we'll the format

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

Operator

[Operator Instructions].

comes Gil Needham of Company. first from Our question & Blum

Gil Blum

place which So maybe shortage. platinum just start is good a to with

we a the cell to in 'XX in half lung Given of the bolus expect due shortage? cancer, short duration of of second relatively much this small should of therapy patients

Andrew Perry

of I bolus would patients. anticipate not a

and very a some dealt instead. were believe chemotherapy not disease. patients be So as in know, we're But being patients I by extending aggressive rapid cases, a the those many offered In space down is or choice some more or were platinum-based discontinued between rendering given were creating with able dose cases, other doses you so cycles. this out, to

So are we'll the those a patients where I waiting wings. in situation don't think see

Gil Blum

took looks if which broader immunological survival towards for on are broadly. trending lot should with kind curious a like pretty and data if closer trilaciclib here, mean, and given on I'm the this effect colorectal even numbers. you come effects class a but a I is really didn't a landscape IO cancer I say guys anything maybe the more benefit, a in time of you typical question know specific, spend And these on of just is more back of the agents. it immunological you cancer -- is this if population whether

Rajesh Malik

TNBC, very our the suggestions we efficacy going in And Yes, Raj. greater agree and data on also where II the in hence, saw with focus you. greater we a data Phase completely landscape. at positive of we is PD-LX this where forward Gil, subset. the least saw ADC strong And on

completely as about we and focusing trial that where it help patients to we be yes, forward. So going we're where could agree going really with that's you learn more

Operator

next comes Our Pohlman of Kaveri from BTIG. question

Kaveri Pohlman

showed ADC any the they wondering of kind the use more get So a of approval of is trial. biased comments study, there TRODELVY provide whether administration some I TRODELVY I because of insight any just you in from median how hoping to And was like The seeing for physicians duration are the on higher the can or for administration X.X showed was chemo previous this if months. trial trial insight administration. also duration TNBC,

some So insight there. I to get just want

Rajesh Malik

is Yes, Kaveri, Raj. this

TRODELVY improves tolerability. As the we reported, trial the combining with

of median therapy. X.X was were on previous patients months. that we short reported still still The ongoing Our data a around relatively follow-up

data OS early clearly, as we're next report we'll following year. that is something and more the this we So report

Kaveri Pohlman

TRODELVY TRODELVY front approved? And could given that for share. market bladder you fair. are All now PADCEV get moved thinking right. combination And line, it's higher has to about cancer, since That's then

your Just thoughts.

Rajesh Malik

that's Absolutely, setting a possibility. in Yes. that is readouts and going trials landscape well. other as to year next of change with a The lot first-line PADCEV

data evaluate certainly be broadly just end So really the the interested be path day to at OS we'll because at ADCs as data potential a but and TNBC. than in the we'll have could that of from developing more in the TNBC, well looking

Kaveri Pohlman

one, R&D study, to maybe that us bladder reported on the compared arm the Can tell the results? you And how control results it. historical today. cancer a Got from the the last you again,

the much from how the you then readout, And be between arm? OS for meaningful? would the And expect do what control arms difference

Rajesh Malik

trial, good comparator you data there maintenance. the in all Yes. know, the is avelumab regimen, because this isn't The a -- XXX actually, the as of from JAVELIN the

so who that make patients into data set. And not it not were part did maintenance obviously of

will. the So you this others, reading EV-XXX could beginning, as you if mean next right is from treatment where that some the new year, really trials of have we'll such the be also I data, out help. and

and randomized -- so run patients controlled trials, no difference because But is why are really PFS. in there's this right, we

So this really. now, applies a that -- combination Right be the to because generating particular doesn't really trial. OS We'll for exist. it's and -- again, controlled for I same our really control think data and have we'll

looking generally, meaningful, to least survival if whether across OS at see you look to X-month shows. trials, to be that's the generally, improvement have considered arm. we'll we'll data clinically in So at the about additional what the a And control but trial improved relative see

Operator

One moment next for our question.

from comes Anupam question Rama from next JPM. Our

Anupam Rama

question. quick clarification a had I

to On year-over-year. XX% the XX% closer versus down being operating expenses

this, what Sorry if but driving is specifically? that missed I more

Rajesh Malik

beginning in realize those at you restructuring CRC on if more or readout recall Anupam. we'd II what's a the what's wound we the year. following That's the a Phase where of of recognize expect as it. these the end cost driving down the lot we Really did savings Thanks, any being down. addition of the as of trials a half year, winding by colorectal, the year driving said that, the we cost of to back That well lot

Operator

of Our Troy next TD question Langford comes from Cowen.

Troy Langford

what and TRODELVY would enrolled all? you population the quarter Just of with the just guess the patient saw that that in OS excite you data then first consideration given really study. data, for next in year combination on I that number all

still then you forward TRODELVY kind if take the readout of as COSELA safety. measures just year, similar with follow-up would that improved significantly a to in combination but And you OS that, saw next

Rajesh Malik

mentioned lower. great poster, more here. Raj mean, the we as are -- No, also look we population Yes, pointed you PD-LX pretreated those rate questions. more with population if as the I and Troy, breast -- efficacy our a in data, the TRODELVY heavily as out both is ESMO prior you different, as response the bit a is And exposure. the patient well at little

more of pretreated heavily would maybe So want sort to data at patient our looking we more how really ASCENT be closely to population. of compares the

a -- If overall around year you the look at a little so. or population, it's under ASCENT

some at the the thinking So a ways controlled would than would about to fashion, want controlled see other and It's months in over again, we certainly better, meaningful the but that. we're to data greater longer improvement I and XX trial, not some say. better, look the

Your be the about to sufficient forward. alone drug wood second take question tolerability

be I settings toxicity. patients less to willing or greater tolerate be think may in to this where more could certainly able earlier important probably stage

So settings the that where exploring how to say that's to are right probably same those OS in we I thinking and some setting. of could now. be sort the metastatic seems consider that Not wouldn't tolerability But in explore. we're also ballpark better areas think

Operator

If to closing Bailey Instructions]. remarks. to it I will be turn [Operator now like no back Jack further would for questions.

John Bailey

operator. you, Thank

being As and always, touch you. to progress keeping forward we look look on Thank later certainly today. this you in you joining updated thank forward our We year. to us for

Operator

This conference is now over.

now disconnect. Thank may You you.

G1 Therapeutics (GTHX) 2 Aug 232023 Q2 Earnings call transcript