GERN - Earnings call transcript Q3 2024

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Operator

Hello, and welcome to the Geron Third Quarter 2024 Earnings Call. [Operator Instructions]. I would now like to turn the conference over to Aron Feingold, Vice President of Investor Relations and Corporate Communications.

You may begin.

Aron Feingold

Good morning, everyone. Corporation XXXX Geron Conference the to Third Earnings Quarter Call. Welcome President Aaron Relations Feingold, am of Geron's I Vice Investor Communications. and Corporate I'm of members by team, today Geron's Dr. joined management several and Executive Chairman John Michelle Executive Chief Officer. and Robertson, Scarlett, Financial Vice Chief President Officer; and President Commercial Officer; Vice Executive Dr. Ziegler, Chief Jim Feller, Executive Officer; Chief and and Vice President Medical Dr. President Operating Executive Officer. Andrew Vice Grethlein, and Chief

potential contained commercial Therefore, heading the opportunity sufficiency differ filed important discussion RYTELO, results and cause refer Risk periodic and and not making of Chip. results commercial and other statements I'll performance, events question-and-answer financial differ Actual session, or and Geron's risk duty related you Before the future Geron actual therapeutic other Factors the factors our our factors. forward-looking over please SEC, we of and lines, facts. materially. presentation events, anticipated to relating those that report are or historical note clinical begin, time the including statements future resources updates and no those will recent projections to call identifies that events to forward-looking be statements. the from those to With undertakes which could with Geron's under I turn to update of could forward-looking this that plans, regarding during that, materially expectations Chip? the in obligation course the to launch, statements we in the

John Scarlett

on Thanks, the Thanks today. morning us Aron. call. Good to for everybody joining

a our has launch the approval [indiscernible] first-in-class inhibitor, transformative and for been FDA year the RYTELO, Geron. commercial Following this of

and which long-term the $XX.X our product. our of believe as unmet expectations. initial MDS the States, RYTELO market we need the compelling of first company as in RYTELO a revenue. we're proposition full quarter The exceeded to product as achieved build confidence value commercial and patients. with value this gives in for on and execution commercial result, This well risk continued In in product RYTELO. we a lower in United net revenue us speaks momentum demand for quarter million well our positioned hematologists As to the high future

Our we eligible strong August primary covering believe by drug will and ITE. MDS our through continuing our patients indication of buttressed IP U.S. exclusivity to that's for provide IP orphan value We claims is quarter, achieved RYTELO of the in to getting this more commercial the specific FDA success the our label proposition market. lower-risk position, including our third granted focus underlies XXXX, the exclusivity the in United position deliver long-term patents in for into on and States June in Today, FDA's the the opportunity maximizing initial XXXX. MDS on lower-risk and

in of in CHMP early first potential XXXX that beginning XXXX. the planning markets in believe we Subject marketing MDS to potential RYTELO we're and this late are be completed in authorization lower-risk prepare review RYTELO the to with half the EU of in launch application commercialize Europe, select XXXX. In could in continuing for the to RYTELO our of XXXX or approval, receiving EU EU approval

imperatives call, U.S. all commercial Officer in on our success Commercial Jim running and performance, Chief for September. preparing joined next hit As Jim you continued color EU early on and third quarter the us know, steps our the of in potential Ziegler this ground provide for as launch commercialization. we'll key more

proceeds. million completion this to morning were pleased quarter's the together a to transaction strong debt a performance, transaction announce in In addition commercial that and synthetic $XXX both of royalty we financing gross this generated

we [ Royalty debt believe also capped borrowed Pharmakon synthetic terms additional $XXX funds favorable senior committed secured flexibility under allowing and million million. with commercial we comprised $XXX Pharma transactions of and us successful by commercial first debt to new provide which have an this our retire facility fuel coming $XXX $XXX existing With million debt. to significant investment to We were million, royalty managed facility, These with of we off that ] quarter us a growth transactions achieved access a potential of RYTELO the and in reflect with future. launch in the critical continued these Advisors,

later details more QX provide this and results will Michelle transactions on our these on call. on

III high-end of with our This Let's rates analysis interim August to in expect dismal myelofibrosis. survival, on MF relapsed development early commercial XXXX we population the net final survival enrollment commercial analysis positive, trial the recent from representing the XX% as JAK with enrolled the our as was III on planning first endpoint, landscape Based this move Phase as for XXXX. as trial IMPACT in in we assumptions most Phase with myelofibrosis trial pivotal XXXX to Starting patient as death the refractory transform primary in a believe an could treatment if is a trial programs. imetelstat need inhibitor well approximately opportunity. trial overall and continue early substantial that imetelstat the

to released in we to imetelstat will later the speak were clinical earlier the potential this of call. MF, new addition which the malignancies, are earlier across in programs abstracts highlighted myeloid hematologic our data ASH exploring that to week. In multiple and impact different were Say

significant like the I'd objectives commercial a commercial evolution as we executed With first the to patients to business of from our a They committed and highlight our urgency that, against launch. as colleagues sense I'll the health. Jim for to these across in the very to of we're call update. Jim? the focus this We forward with months key appreciate contributions deliver RYTELO over Finally, hand our our future. deeply a to company X looking commitment company continue

Unknown Executive

this and Chip, for time morning, the at you, everyone. Geron to honored am join Thank good company. I important

with lower-risk the MDS with patients have of RYTELO, to we With U.S. of lives exciting improve transfusion-dependent opportunity launch anemia. an the

expectations. in achieved U.S. of our exceeding full key quarter XXX QX product the Demand As with sales. approximately centers launch Vital through our come $XX.X first first month-over-month our highlighted, Demand from targeted accounts. has which of In launch, months we of XX% ordering Chip from QX million few represents revenues net in has performance increased

strong in clinical and This first-line ESA in reinforces RYTELO's lower-risk need the profile line ineligible start high plus second unmet MDS.

We is in community Our transfusion across indicates clinical transfusion cell and significant its payer responsible clinical we duration achieved coverage approximately market RYTELO's research treating data for and for of blood guidelines. Rytela's rates, settings. red academic lives red support critical hemoglobin appreciate profile XX-week Patient that broad approval XX% cell in and/or median payers both treatment patient subgroups also strong differentiated clinical since physicians year blood and X and medical access eligible and label rise. U.S. trials implemented are for covered utilization with FDA NCCN adoption policies believe of consistent RYTELO independence coverage uptake have independent have

issued regarding We weekly what trends Additionally, and investors We including sales may to from centers these there that in compare RYTELO RYTELO. believe them with are we billing patients permanent J believe code data around becomes the capture. while XXXX weekly and I permanent questions directionally see as will claims trajectory our data reimbursement consistent in data our J X streamline in reflected for January to was own demand want incomplete internally, October when the XXXX. caveats reflect code effective of acknowledge insights, on this treating data. that are third-party also we with claims

label data. educating believe execute J-Code. Also, of from of driving we across new on particularly remain field and approved segments, NCCN second payer by and in deliver newly We an including leveraging the continue of based imperatives, several appropriate must source launch strong the of strong the observations management week-to-week access HCPs reviews. key with patients reinforcing fluctuations market and and sales all research, to the treatment line, chart of RYTELO HCPs NCCN continue regardless and on duration we platopenia growth, payer eligible stages appropriate guidelines early the supported the ongoing utilize value in HCPs steady positive to including coverage, our guidelines, expect To on will

our in of so RYTELO, launch to Rite the and projected the XXXX date brand. demand growth in momentum continues expected for promising. demand to Continued sales sales be the far, data our long-term growth From fourth quarter into progress Overall, confident remain internal own the trajectory we

#X Our is commercial priority to strong U.S. deliver launch. a

on We to objective. We U.S. that to leverage also plan to XXXX select laser-focused experience keeping and commercialization for EU countries are in launch our committed prepare in beyond.

countries. prioritized is optimize for in Europe access in imetelstat goal Our and patient revenues to

we mentioned, as As assessment, and This contracted XXXX. regulatory select can critical provide receiving commercialize HTA access distribution. market who in parties experienced includes RYTELO subject working approval services, path are preparing with essential reimbursement, third such EU Chip including in countries to activities to

have eligible by we RYTELO. in teams cross-functional dedicated to the acknowledge access all and am broad to hard to time timely future. I that and how remained Geron want the I this patients work inspired am ensure optimistic their summary, during of In transition at focused for U.S. have I

With settings, a We dynamics are policies and turn financial I'll across demand our growth. early update. strong call payer to that, These demand reinforce academic segments. the pleased favorable patient very continued for utilization and expectations for with community coverage promising RYTELO broad the and across Michelle Michelle over for launch

Michelle Robertson

good morning, and Jim, Thanks, everyone.

available For the which on results, this press is XXXX to QX financial we website. issued refer release please detailed morning, our

and debt term this performance with then and financing quarter attention the this bring morning. and royalty pleased new royalty with your securing discuss are announced financial loan We agreements. key synthetic commercial to a our results and QX I'll senior

September securities. cash, XX, marketable $XXX.X approximately cash of equivalents, XXXX, in million As restricted we and had cash

cash including debt, XX, payment our proceeds is million The cash, tranche revenue revenue was sales was product and cash in XXXX. XX, of and net from in Total $XXX,XXX respectively. to Pharmakon Total order Pharma prescribers as and $XX.X X due XXXX, which same June of XXXX. revenue a respectively, loan million million, U.S. for first we months September was and million, period September million X gross to to On and the XX, product net existing for XX $XXX.X September restricted basis, the of the compared after the from securities increase upfront X for specialty of $XX.X X of in $XX.X RYTELO, approximately agreement the $XXX,XXX months ended and repayment and $XX forma for available as ended the from Royalty XXXX. revenue pro equivalents, had and distributors and marketable the the under months

X months and XXXX, million, the XXXX, million and X $XX.X X the respectively, X to and expenses the $XXX.X was is expensed months X same which months for for due the operating $XXX,XXX and Total million XX, period XXXX. RYTELO. of months $XX.X million development for the were million the distribute respectively, and in were $XX.X Cost period in ended and costs million $XX.X The manufacturing XX XXX,XXX period. $XX.X consisted $XX.X ended in XX, decrease and to manufacture X approximately of September and current respectively, to in for of same $XXX.X expenses period to compared million, to and that September for Research compared due ended goods sold September and quality and were and approval RYTELO primarily prior XXXX. FDA being capitalized the million cost

$XX.X administrative increases periods and increase were million expenses the general and and the expenses, connection expenses same of selling, in months primarily RYTELO. related reflects launch with XXXX, and ended The and X count XXXX. general in U.S. administrative commercial and September million in $XXX.X for head million million, $XX.X Selling, X expenses launch respectively, in higher and XX, the $XX.X for

XXXX, we approximately be to $XXX expenses in of range to year million. operating fiscal expect $XXX million total For the

received in and exceptional access financing to pleased royalty million $XXX announce to debt of Pharma gross Pharmacon morning proceeds. closing Royalty that the X and long-term million in we are this us have which with we advisers capital with of Finally, provide partners, up synthetic $XXX

invest position on These a the we equity overview markets. strengthened financings, dependence on balance Form cash please and solidify review our terms the our in of release of detailed issued the sheet. further We and considerably our our to For financings the reduce flexibility future X-K website. and provide our this press these available morning capital

First, maximizes agreement with we into synthetic which have flexibility. we Royalty and Pharma, believe entered prioritizes of capital a operating royalty cost

million. Importantly, at the royalties are $XXX to Royalty closing of Pharma our capped payment X.XXx

XX, words, amount is all This other In or hard at Royalty after Pharma June that that sales by receives the date. we after cap retain Xx reached. XXXX,

agreements. are X.XX% be capped sales over million X% billion competitive RYTELO, will of of believe royalty to $XXX for Our terms million annual billion, sales U.S. $XXX for to payments $X dropping and we net between and royalty up which $X X%

allows agreement the and Additionally, date maturity economic a for very in upon no royalty flexible structure repayments mandatory agreement or control. prepayment believe is royalties a optional with clean change We of the ratchets. this

with with In transaction a X-year to for addition Advisors we to funds $XXX secured into up Pharma, by the managed have million. senior entered Royalty Pharmakon term loan

$XX.X At loans drew million under closing, used this Bank, fully Silicon with Hercules been now million $XXX and existing we has to we of repay which our terminated. Valley loan, which

to so another the the end million floor secured or option available draw facility scheduled bears subject and revenue at no of interest super outstanding ability no maturity a The X%. in payments XXXX, there far, specified year $XX which The the X.XX% remaining X-month loan contains per plus have principal be at due of million available at the of option We rate by financing will a XXXX overnight threshold. covenants. at reaching our $XXX our all with rate and million variable are subject to to $XX financial equals amortization

the today. operating marketable redundancy the commercial for months the very U.S. securities, allowing transactions supply to financing including agreements capital and current equivalents our the the in the cash, chain invest received trial anticipated the XX for from on revenue payments from of we We general in operating RYTELO Phase RYTELO upfront at of assumptions, and are cash EU, in RYTELO be U.S. MF potential to existing the and favorable pleased with relapsed/refractory will these terms. under fund complete sufficient launch fund believe working our supporting requirements continue projected our and IMPACT launch MF and on sales completion requirements. nonequity our next III least plans of in Based us

a are these U.S. support capital. where clinical With for to financings of equity there business. call have Overall, us position capital fuel that, believe drivers turn I'll growth very believe We we sales Faye? and Faye we to over to strong raising can take our future critical without value medical continued the scenarios update. for and a profitability

Faye Feller

everyone. about our use that commercial the lower-risk hello, to particular of around my setting and and in for to cytopenia for patients start it and MDS medical information hear been Michelle, develop how has entire the to I'd motivate to Thanks, deliver impact team meaningful like RYTELO by team sharing me feedback with field the HCPs sequencing as hematologic RYTELO setting, imetelstat The in and has myeloid to support team treatment. commercial on requests management malignancies. been other in they responding with further education

we on inhibition focus which abstracts this continue ASH will and telomerase myeloid I our as Today, released treating earlier approach malignancies. to imetelstat hematologic highlight week, important powerful with to believe an

]. view release our detailed on Astra website data please issued visit on For or the [ on we ASH view the the press Tuesday available website to information the abstract,

lower-risk First, imetelstat as I an will with cover patients accepted prior that in Phase ESAs, the clinical patients. therapy. MDS II, from Abstract activity Phase HMAs new and and anemia clinical with the and trial, analyses EMERGE EMERGE transfusion-dependent regardless of suggesting evaluate clinical treatment, prior for pospatercept XXX, III the substudy on lenalidomide these effect of including activity pooled across presentation, oral the QTC demonstrates

small X,XXX clinical cases Abstract patients poster Although results numbers limited related suggesting accepted Merge safety on reports of and with ventricular per imetelstat guidance. RBC treatment believe data and we first the conducted presentation, efficacy the and experience have later QTC regardless some important data as hemoglobin we of prior sub-study FDA outcomes history. have in lines repolarization benefit their improvements these transfusion and clinical these a from treatment, that an and implications in

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debt safety the response were QX Phase to lenalidomide comparable including notably, of prior study, efficacy III that receiving EMERGE in overall shown into this sub In and of the to HMAs. were in luspatercept, patients seen population And treatments, and imetelstat trial.

on chronic the therapy assessed anemia cancer or post a of as assessment of the PRO presentation, as functional factivatige, questionnaires. and of scale abstract, or patient-reported poster illness matedisplasure measures, or life QAMs analysis population, and therapy functional by the outcome validated FACT The of accepted XX.XX quality third reports or IMerge hoc AN assessment

in maintenance July enrolled outcomes the The XXXX. and which are and shown the XX to as first these on dose per MS of dose of life I analyses patient. oral quality improve [indiscernible], patients. received these encouraging from sustained aim or improvement muni were of meaningful doses very in clinical escalation for trial, of individualized Part fatigue as the an XX, as we of symptoms, least At each level X of imetelstat in patients ruxolitinib reports and imetelstat, improve safety results I accepted patients presentation, Phase

No MS, on events X.X with pharmacokinetic with studies. combination and imetelstat ruxolitinib team other of combination potential was data Also and to efforts. in kilogram inform milligram were ruxolitinib. monotherapy adverse dose-limiting recommendation confirm our similar this of progressive support imetelstat tolerability the those toxicities assess in profile were dose-finding X observed previous the observed, could The of unanimous of review early development the safety trials is consistent with of future per therapy These Intelsat based the Part study's safety the profile clinical debt. imetelstat combination which with and the designed study, results and regards X to in improved study we studies, evaluation of from the of adopted to

treatment. first none high-risk evaluating relapsing with X the the poster or either of scheduled improvement the part every II weakest. in which individual lower anti-proliferative to some [indiscernible], endpoint collaborators from presentation, decitabine and azacitidine trial, observed refractory Phase IMPRESS MDS was visit Geron primary submitted including a X as schedule was in cases an the plus or and Short-term AML, by glass or of provide of trial, imetelstat in intolerant patients imetelstat of effects, azacitidine. interim hematological or X decline high-risk the MDS and a analysis cycles or accepted transient MDS In the values on patients reach after venetoclax AML-treated in risk dosing XX patients showed weeks in

safety already starting now protocol with modified cohort, more a the is that schedule for dosing second on observations August was for Overall, cohort schedule first XXXX. no to amended known in imetelstat. the those frequent treated new and signals patients. a enrolled occurred in beyond of being this a Based

identifying Lastly, invited resistant Abstract vivo. shares in XX may lipidomic cells AML subclone. in submitted be mediclacytodine imetelstat imetelstat develop target to by preclinical insights data treatment presentation associated correlate alterations responses pheroptosis AML to General as imetelstat oral unaccepted an collaborators that These with the leveraged optimized strategy therapeutic using mechanistic

forward the will updated over call look turn I to you keeping our to development Chip. I now clinical on And progress. back

John Scarlett

launch Thanks, quarter's trajectory months X only performance and payers. for receiving in confident very we're Faye. customers with pleased To this and feedback this close, we're opportunity into growth. recognizing while our long-term the obviously and we're from We're launch.

RYTELO that can treatment high that in low-risk this for subject conviction become patients patients, in and care paradigm benefits it MDS part of bring to have unmet the can U.S. approval to and differentiated eligible regulatory of standard We in the EU. need the both

the We'll looking pivotal MF now open the to trial In in value questions. forward lower-risk significantly We IMPACT the commercial Phase in MDS, for approval contribute MF Operator? for believe readout and to relapsed/refractory the are very of RYTELO that lower-risk future. of line we're outcome in addition MF. that milestones trial a III the MDS in proposition our also in the positive to key EU Rite

Operator

[Operator Instructions].

of comes Cowen. Tara from Your Bancroft first line the with question TB

Tara Bancroft

great congrats on quarter. the

the this us But even were you the think the have year? your quarters give few could of how market assumptions especially for could next idea RYTELO look over next quarter, you of the you a the So better over curious growth or I'm cadence given into we what factored seen royalty deal. ultimate growth how hoping and terms

John Scarlett

mean a [indiscernible]? for what factored into the this more little by what bit you Could explain do the Tara, Chip. royalty is you just

Tara Bancroft

couple were you for over growth the the kind your deal, or assumptions when Like the of were next factored of how market into years that? negotiating ultimate

John Scarlett

take that? to like you would Michelle,

Michelle Robertson

Sure. think, about structure. just answer growth can on And how Jim quarters. Well, then have her don't I we is Jim, comment I coming question, why which the we're thinking about over first the

Unknown Executive

Jim Ziegler here.

of So what the patient is at and expecting across we're segments. steady, growth all consistent looking is

Specifically, guidance the third second positive, relapsed/refractory steady then, are this RS expecting not X-plus growth RS-negative and ESA-ineligible line point, giving patients. course, consistent going but and in first-line both We're at forward. and we of

Michelle Robertson

And I'll Sure. take the one. second

I to very extremely just terms, and determine was with want that and -- and internal all, which happy pleased our the process, We the competitive First very outcome. current negotiate this we're used just forecast with. say of to we were again, an

Operator

is question with Partners. from next Faisel Leerink Your Khurshid

Faisal Khurshid

you Just don't two if questions, mind.

First, well think clarify percentage should just on investors just Can kind the as thinking royalty rate about on the cap you be of of rates. the multiplier royalty that. as you sort how

it could starts bit little think cash I you And on like out higher the lower? rate then kind then a if seems deals royalty comes just of clarify than typical expectations. your

Michelle Robertson

Faisal. Thanks, Sure.

comment on So done been very $X.XX Royalty very with by have it royalty competitive. going to the date. Pharma, We're that I happy is at not achieved a deal cap a is I'm other certain transactions again, mean, that

But X.XX%. projections, sales. can focus our is current what we I we we cap is of our confident from that and reach feel peak prior that so that think revenue again, plans rate think that And that on pretty the internal on we've our And competitive to seen. meeting based

[indiscernible].

feel we my cash runway, these revenue, breakeven that are there meeting script, feel can plan additional needing scenarios our our projections reach we to internal as could again, current the equity transactions on several in over our would financing. us mentioned OpEx based the where mean take without years. And that I that breakeven, next we On X

expectations XX months on not months cash X revenue maintain forward. QX. these And OpEx and to XX these to of based clarify, to our of this of fall I again, of One said, as our cash, allow goals just projections. transactions going transactions current in was below us

of maintain XX not I previously QX What of of know to of cash months have below fall one because has can saying XX goals XX we saying So months. about we talked we're into we cash not which been is months always that that our XXXX. we're cash,

Faisal Khurshid

makes your clarify to sense. it comments. And Yes, then just

So earlier like assumptions on are kind you're the of your that side. saying that multiple you internal of the kind trip

Michelle Robertson

meet If projections, revenue current internal our yes. we Yes.

Operator

Next from with question is Corinne Jenkins Sachs. Goldman

Corinne Jenkins

did the You that kind growth could of clarify what you mention but expect a of you? to in steady terms bit over quarters, growth Is to that coming see rate. means that little number patient you growth the about of like absolute or

of And little helpful a be third-line you're has patients? them would terms rubles clarification patients what primarily there. come seeing previously And portion to Just therapy, at stage? this of in second-line then are or been the that on these

Unknown Executive

Corinne, our is of not XXX but we call our in what is both on earnings guidance, we is terms Jim the And growth ordered. in of across What Ziegler. all providing provided that this patient and Again, segments accounts targeted growth. this community expect we're setting. have academic

we're Over and breadth. time, obviously to prescriptions patients prescribing depth are accounts. expecting these the across is that's So for breadth what of the increase

reinforce utilization seeing segments, ESA just ineligible. in all uptake we're first I'll including that patient line, So across

patients Second then line at this point. third and line

Operator

line from Barclays. the next of Your Carter question with Gould comes

Carter L. Gould

just how and depth of Maybe of follow-up but would a start experimenting what prior in early and with spell from housekeeping is sort the with questions. impact you be is talk back ordering math, guess the commentary The then I of with guess that very or then numbers, any Can maybe as envelope it around breadth And out helpful. quarter patient our does off argues centers bit you're the stages. on providing start two against this Can would one adopting impressive. and suggest question. be helpful. a prescribing in a I that little that well inventory still of Ebolas just are -- if its about I'm and the there implies centers product what any And much as maybe you

Unknown Executive

Jim Carter. Ziegler. Great. Thanks,

in of terms inventory, and typically see in bill, buy is and we're and So of that in between we X what right range. inventory, weeks X

consistent expect. that's what So we with would

questions, first of relatively in full our quarter. the we're and early terms In This still breadth is depth launch.

observations And we And the depth experience. are are on, breadth continued time, expect seeing forward. these over to so see breadth going then your correct. getting in accounts we're and physicians Early

we high need. RYTELO terms option. think way In of still unmet bolus, about another gives treatment is there's it patients the a

growth. steady We consistent not did model within bolus. John expect We a

and and expected in what growth consistent steady launch, We early that's we're seeing.

Carter L. Gould

patient guys number, that? the And starts providing you are

Unknown Executive

might other Yes. you know, the the Carter, market, -- and I'm way data not hard patient start the that in get we buy in as bill don't on you with markets.

dose, way versus the So patients divided dose to starting or is would or account sold, time, the specifically give by interruptions it continuing were reduction. wait new it the that milligrams patients dose on doesn't of total patient take that think about what X.X is, you assumption you if your for average range. patients, but

we're why a because that give to going not clean it's that's number. So calculated number. It's forward going a not

Operator

H.C. Your Bodnar Wainright. Emily next from with is question

Emily Bodnar

reductions you of benefit the the safety and a line kind can you terms also initial good quarter. [indiscernible] then discuss Congrats And at curious you're on how line? [indiscernible] I maybe if transfusion seeing if in Are if of on the real-world the impacted this of profile. first-line experience study. on in into EMERGE some guess, in kind data treated with patients And setting the seeing first all? more transitioning with the the previously of more has launch,

Unknown Executive

real-world is from and consistent sort upon of again, And of It's that field compete I'll our jump again. their first-line line. Based chart for you label trial in launch Jim still on against the ESA patercept, and that relatively then that and is right to will our which terms market on that And March. I expect in audits. like patient in that in allow ESA line. insights in. that expect patient early we for also the patient in compete at performance care of question, become ineligible they product we the with maybe research on Faye first-line compete What as that whether regardless take of it's as about can standard experiences XX% much the But profile first-line relatively first know. in clinical still from still least is of expect or commands, early part I to and that first we differentiated us luspatercept would patient the population, now share the It's have will we second And well. trials. are that of get ESA

Faye Feller

is This Faye.

which we the excited from for overall hearing option and and I -- our managing to what providers community any have are their comfortable patients. for the Just their of [indiscernible] and cytopenias add field this these saying. early, RYTELO was but is use to enthusiastic It's still that for are

Operator

Stephen is next Stifel. Your with question from Willey

Stephen Willey

just in the about address first world that the few of on terms I progress. little about in during then trends could of talk informing I review was of your between Michelle. utilization current follow-up maybe a I to guys the are playing you the wondering And relative you dose have just just and and mentioned talk split Can data data that of the terms you're you how are just IMerge. bit how just know cytopenias early a that the seeing. looking. then the Congrats audits prescribers, split terms community if in is getting. chart But you occurred it's to cycles in out typically real for management academics utilization

Unknown Executive

roughly in Ziegler least right XX, is understood. to X/X. is then that Jim academic expect split is of well from hearing as well what our The and a is clinical that now, the research the community I we again. as X/X, There both And management support Stephen, trials. concerns, we're personal, good physicians between or XX and nonpersonal And associated management as market observations cytopenia appropriate RYTELO. field our cytopenia cytopenia have as it lot at is management and real-world aren't major would help efforts with Sure.

Stephen Willey

the gross maybe kind longer-term range. net for know Okay. in you've Michelle. kind And of to then of given I mid-teens guidance

excludes curious if forward. you steady cost of going And you a the of also, quarter. impact kind the to assumption if impact royalty. just net obviously, a us curious goods for the gross Just give that goods can give royalty will of state us the number of then cost transaction could But

Michelle Robertson

Yes, sure.

digits. the as believe in COGS. the have on net we the we expect increases, volume quarter. That's can we the math we -- the once -- mix, XXXB continue we then around double had and middle mean, -- But we forward. up digits. COGS, continued it the go loaded of review anticipate mid-double to not to -- specific in to kind that's I been mid-single guiding what get on of of you guide that was third it what slightly to sort we guide So mid fully out do I to digits the that And going ended already gross so we was. COGS inventory we're the be obviously, this on But on And our expensed, mix.

Operator

Riley Next question with Patel is B. Kalpit from Securities.

Kalpit Patel

raise, over cap a especially for specific maybe Michelle. what you structure can simpler first company made preferable? approach you of the given was more and equity chosen I market guess Maybe why royalty considerations the this on debt current elaborate the

Michelle Robertson

Sure. Thanks, Kalpit.

result we current is terms funds options Hercules unfavorable how and extremely once debt so various and had terms. of that We to with to pay we the Pharmacon. we about we from have much us, terms, had carefully that take and did debt off which available process. thought off we on that could received an pay those the structures on transaction, the again, our competitive royalty this Based sizes across that both in were ranged a So debt

and And not of was the And right sales then struck equity markets, again, further ours goal which amount to we retain early the period, our was the the that the this this reduces of balance. dilute dependency stock. felt to on launch the just in

Kalpit Patel

And it. consistent of what trials? that maybe these or in Got continuation rates clinical far, Okay. you're the do treatment. that then adherence month-over-month the data patients who you are How rates started for the sense is with early have an so seeing

Unknown Executive

right trials. over have a management not say that to time. would I'm it's we're more any number mechanisms. But this for now, point. This comfortable at that we're Jim over time, of early. better through anecdotally, with different expect is obviously data be what month-over-month And still consistent clinical It's to aspiring assess treatment I is given But something then obviously, we trying to again. relatively

Operator

comes next Needham from The Company. question Gil & Blum with

Gil Blum

impressive very of sales. Congrats first on quarter

us. from couple a just So

further additional this which potential a regarding in on just profitability, the on Or you months that that in sales really, think XX U.S., that Do Is myelofibrosis? on you there includes capital. is is question have the busbar? Now plan example? expanding you've for assumptions my investing about keeping mentioned. other And

John Scarlett

and you don't why go Michelle, star? ahead

Michelle Robertson

Gil. Sure. Yes. Thanks,

So we structure for flexibility. the this hybrid the why reason is chose

always for and redundancy to you for now the and of extremely drug have in substance. we down that It strategy us. a us We to as So also RYTELO access This took RYTELO. $XXX our supplier million. important second and the we looked U.S. second has around $XXX another allows our allows ready support us redundancy at invest first been recall, to million. for to get to commercialization really, still and supplier continue

all plans U.S. the And us allows And cash than potential XX going our on But And you launch. a of capital are -- EU as months to for some -- but forward. also then mentioned, of those more retain [indiscernible]. for it current in preparing we commercialization start costs it's in spending

Gil Blum

they profitability on and myelofibrosis. assumptions Regarding if include

Michelle Robertson

takes yes, I to -- and But there low-risk just we are projections. revenue internal projections. and include where OpEx plans revenue MDS do based mean, scenarios internal myelofibrosis, Well, the breakeven our our and financing again, with current our there in with on us

Operator

turn This the will to Aron Instructions]. closing call question-and-answer the will [Operator conclude I for session. remarks.

Aron Feingold

very look Thanks Thank in during interest this everyone, today. your so joining time and company. you to keeping for our you. forward Geron updated We much, exciting for us appreciate

Operator

you for call. This concludes joining. Thank conference today's

You may now disconnect.

Geron (GERN) 7 Nov 242024 Q3 Earnings call transcript