Earnings call transcript Q4 2022

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Operator

Good morning, and welcome to the CTI BioPharma Fourth Quarter and Year-End 2022 Financial Results and Corporate Update Conference Call.

As a reminder, this conference call is being recorded.

I would now like to introduce your host, Remy Bernarda, CTI Investor Relations. Please go ahead.

Remy Bernarda

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

note statements this based please be we begin, forward-looking making on we that call, during will Before current expectations. on within which Private Form our filed Act in our are Investors provision XX-K types of not and statements the recent are the as the the the our of section. with Such forward-looking identified safe limited of website to, the reports XXXX, annual Securities subsequent of Reform most available periodic statements Litigation in SEC, including, but meaning harbor report on may Such many forward-looking not indicated materially differ the by that views as and performance including such anticipated cause date those seek forward-looking terms control. from statements, that subject of of guarantees are and represent the actual statements, which are results as are our are expect, risks and intend to call beyond by future of this to our uncertainties

regarding adoption product the timing include runway, to our statements market launch. success expectations future profitability, These and cash of VONJO of our

addition, views today be representing and as views relied subsequent upon forward-looking should our as of statements In of not any date. represent as our any

our intent While do the future, any elect statements so forward-looking in we specifically disclaim even to may we update these views if change. to

Officer; see Fong, as of statements Chief Dr. we our for risks periodic well Officer; to Kirske, may Executive reports cause and will After your Medical as Officer differ For the related these actual call, our Jim and formal a David forward-looking we SEC. and Chief our risks further call our have results Financial in Chief open filed Interim On Craig, Adam Officer. remarks, President, expressed materially our description today's questions. Commercial other uncertainties our Chief please and business, the that with from the to those

I would to turn like the to over call Adam. now

Adam Craig

of have start the a the everyone timely We call a today year past portfolio by than presence. following the research joining Remy. we we've strong us fully provide release a from planned recent organization integrated want you, a reflecting our as the partner. to Royalty update development we to Financing that and made appreciate over can Good I earlier achievements revenue biopharma morning. by with Thank so commercial on transformed

In generated commercialization, achievement in liter. we We in nine treated just from internal months patients the sales process, the efforts count last first for XXXX, FDA of disease of with and in for X,XXX as goal rare to accelerated year-end a a MF. myelofibrosis VONJO, first year, pleased meaningful This and with extremely date. to approval the our such launched quarter pacritinib million below $XX the XX approval commercialization received X we XX adults progress in per platelet net over the our VONJO a the of times for with exceeding treatment with our are revenue

improvements cytopenic is that thought that production in and inhibitor provide benefit lead by Dr. will December elaborate anemia A on ACVRX data Washington But in ASH oral presentation, New in I'd in to his myelofibrosis it X Stephen at the to just Fong In pacritinib a hepcidin independence new potential of patients significant a in the Annual its inhibition a shown Orleans type is Jim patients. and transfusion activin spend time presented the receptor has success little like or with talking about in anemia ACVRX potent to myelofibrosis. our to Meeting commercial was University. mediates moment.

disease disease develop from course due drug inhibitors. both approved is and in other Almost of anemia the progression MF Anemia and all a JAK factor. toxicity it's therapy, their common the to poor during will diagnosis MF, prognostic patients over and/or

clinical inhibits pacritinib related vitro to to findings demonstrated in The target. to that presentation times shown potency momelotinib was led when data invaluable to key with reduce included with greater approved Oh’s highlighted improvements levels. demonstrated that independence the treated inhibition four Dr. study. treatment daily, to X patients milligrams It VONJO XX-hour which In anemia compared data the and transfusion of available in ACVRX hepcidin therapy, XXX at ruxolitinib PERSIST-X several at pacritinib. compared Phase dose the of vitro in on twice

extension And have drug term end, seven franchise label VONJO we extend establish by space. in VONJO we granted by last that with year, of this indication a this would have FDA patent last the years main the was to five of XXXX. the filed our if began orphan February granted, composition matter date exclusivity To years the patent month, of commercial term exploration Over worked for in XXXX. our expected for an for that hard

As for we care the providing best our product year enter of with we generating VONJO, focused myelofibrosis. cytopenic on second commercialization while sales, are quarter-over-quarter patients to

With that, hand Jim. the to call I'll now over

Jim Fong

everyone. morning, good and Adam, you, Thank

commercial look proud X,XXX a IRAKX We by and exceeding team our our milestone affairs my myelofibrosis highlighted back a goals the many VONJO, ACVRX I led for achieved XXXX, over team accomplishments reaching nine the the treating patients. who launch first I'm launch, extremely JAKX of successful on of of internal As colleagues over inhibitor. revenue and novel medical months

accounts, including order starts, across increase active as performance patients number several bit double-digit in anemia the hematologic and profile is provide a these a of momentum XX% very launch and completed in for growth Looking so in substantial refill producing. on continued of continued growth QX in XXXX. what on sales far of increase as encouraged a consistent sales team by a quarterly and context the Today, we more interest significant new thrombocytopenia. a are in numbers in safety strong MF snapshot VONJO, growth well prescribers and to patient new I seeing in show are increased with provide We quarter and expanding metrics, VONJO's ahead, awareness sales key strong strong will our the we and rate

are more our professionals. continue the educating VONJO on efforts, health on programs peer-to-peer are than important rationale cytopenic X,XXX becoming we to such therapy scientific we VONJO. this aware the of with they disease existing these focus Due an resonating have to XXX prescribers new MF. for providers, The approximately of and as and care a maintain VONJO clinical reaching conducted as a benefits for and different treatment physicians MF increasingly recognizing requires option Throughout XXXX, VONJO. education is To trend, that different as

As of prescribers grow a the accounts continues proportion users. a number high VONJO and new repeat and have become to result,

QX of at the – for use or patients. with compared majority in XX% label, coming research awareness FDA-approved team evolve. commercial promote counts NCCN with to we from the the QX, second-line VONJO. XX% market approximately the VONJO current In to VONJO with only microliter patients per only utilization consistent use Although, my of indicates can seeing change platelet are in utilization of recommendations This increasing is of likely use above XX,XXX the related is

growth In a addition, an therapy. we as duration of seeing well treatment overall of in VONJO as as increase first-line are

and As our previously mentioned, expand continues adoption to physician with penetration. user base broader

success prescribing as physicians that evidenced the the setting. exceeded fact has our physicians VONJO by The market in is now community the academic number of penetration

versus of adoption community recognized, we the typically the academic slower As treatments new much centers. in all is

number potential for the growing this VONJO coming sales prescribers the of increased from believe over will community, into time. I With translate

XXXX. has carried nicely momentum into sales Our

I forward our consistent updating May in seen year, first demand sales have to start quarter the look to you and results. We on

also of In to with patients. whole for strong entire due as garner MF audience. the summary, mechanism and recognition cytopenic to of continued by community hematologic a continue among growing becoming physician profile of we Notably, as adoption is increased acceptance VONJO’s action the increased top awareness from mind evidenced VONJO differentiated brand our our safety MPN

effective meetings. progress leveraging in commercial and promotional efforts at their continue team major highly presence to XXXX, maintaining our and medical our expect robust a significant educational We

David I to call our turn discuss will the results. financial now to over

David Kirske

Thanks, Jim.

quarter for year-end available results financial summarize current XXXX were Therefore, our I in status. this Our published financial will morning press our are and and fourth website. our release on the

to mentioned, As sales increase product Adam we our quarter-over-quarter. continue

the goals. in we $XX.X quarter nine of net pleased revenue our $XX.X in the I’m XXXX, that for to months For exceeding commercialization, and report revenue million fourth generated million

revenue attributable All of entirely sales was to VONJO. the

the sales, oncology drugs. the which common most towards year, of product holiday for observed some expected, is with seasonality we our end As

overall investment in continue also VONJO reductions in loss commercialization meaningful marketing SG&A full we sales product our the of in operating related and product. fourth provided while to quarter year and the

and received $X.X Trust investments cash, Subsequent the as in cash in short-term $XX.X of with royalty Our from additional to Healthcare January we agreement totaled quarter, equivalents of our end funding XX, XXXX. the million. DRI million XXXX, of December

XXXX. on by expenses, to is the current be of and revenue objective Based projections our cash positive flow our end

forecast. development meaningful any or clinical changes However, would this plans transactions our other impact to

conference investment the active an have We over months. several next schedule

Needham XXrd Healthcare be will be Days will and We Stifel Virtual at look Conference, and March in We you interactions in Oncology Wednesday, Cowen keeping X, on our these the the updated Conference April. progress. TD Healthcare we and to presenting forward also Annual on participating

remarks. turn to closing Adam back now for will I it

Adam Craig

Thank David. you,

as and to you important cytopenic as we the safe today. now of medical simple, effective our commercialization with We established CTI MF treatment an offer are share VONJO in delighted with for the on accomplishments patients therapy is a of leader condition. market

the are revenue focused For driving we with of of VONJO expanding aim use the quarter-over-quarter XXXX, on growth.

additional to for increase indications. continue through potential We to ways explore also the long-term VONJO

to Shannon the This I’d for remarks. open questions. like ask line to concludes our formal now

Operator

Thank comes first Securities. Shields question you. Instructions] from the with of Ken SVB [Operator Our line

no Your line open. is

Ken Shields

and quarter. congrats Thank on great the you

were this. XX if mentioned off-label on myelofibrosis platelet how patients could XQ. patients you anemic you additional you many color have the Thank on on XX additionally, then label were you. So any higher the who if wondering or for have mentioned had these provide you’ve off-label I’m versus to – seasonality potentially population. Wondering impacts some And counts? patients of color potentially

Adam Craig

Thank both Ken. answer questions. those you, I’ll

something level Society on we a we that whether all, the of don’t are quarter off-label we of the who seasonality, treated the of what seasonality American is really have anemia. That’s to the not holidays. on meeting. The expected. With Hematology very have – also the for much patients First regards last busy That’s is have. detail quarter

as takes who So there’s same are the out on that do of space. going companies in we oncology the the doctors many in lot many, a and experience way seasonality office,

Ken Shields

more, Okay. Thank I you. then one just And can. if

DRI. Any have that what that Do milestone does obviously the color guys was? and million of you the cash XXXX? expected from by this any there? you you. guidance $XX additional threshold milestones on color Was factor are Thank positivity into So that And end flow got year.

David Kirske

is to David our don’t disclose cash into incorporated milestone We of with is here. guidance Thanks, our the it Ken. that This payment, respect details forecast.

Ken Shields

Thanks. Okay.

Operator

Thank you.

Ben comes of with Our Stifel. line Burnett the from next question

is line Your open. now

Ben Burnett

much. just two very you questions. Thank want I ask to I guess, quick

to ground that’s launch? getting the gained most bigger First, the aspects of terms And of it there kind is of in be community? the over Are a do the focus? launch I into the VONJO guess, where you see near-term other about deeper

Adam Craig

Hi, Ben. Jim, please.

Jim Fong

Yes. Jim. is this Ben,

we essentially, expand there. coming and So see continuing to yes, growth the community from really the

So get no addition, continue for – well. doubt that get to for. looking as the patients And that’s prognosis looking us in obviously, queue observation in we’re the we’re to better

Ben Burnett

Okay. treatment? Excellent. of duration I expect the the so And seeing change that that the sort of of of does average you that taking of be? to patients what point, VONJO last are other from on time? initial words, I patient expect duration treatment of what guess this guess to Do representative So bowls you in like you is of over in patient, average terms kind

Jim Fong

only Yes, we’ve Ben, months into obviously, nine our launch. had

prognosticate it’s to tough the on durations. really So

point, of However, progress poor patients initial the any the the patients. to are to launch, probably – like drug be new a your going

that. And so the typically of parallel durations are

of parallel mentioned and use is evolution However, before, the the that. of towards prognosis seeing as we durations better the patients, VONJO we’re

Ben Burnett

Thanks Okay. Understood. much. so

Jim Fong

Ben. Thank Yes. you,

Operator

you. Thank

Our next of from comes Gil line Needham. question with Blum the

Your line now open. is

Gil Blum

you on how Maybe congratulations remind are could us and everyone patients diagnostics? many morning, cytopenic Good the on progress.

Adam Craig

Jim?

Jim Fong

Yes.

essentially, you So at Gil? said right, diagnosis,

Gil Blum

Yes.

Jim Fong

Yes.

will will about at patients approximately have a of without and third probably XX% of at So anemia patients of counts platelet XXX,XXX have thrombocytopenia. diagnosis, diagnosis less than

Gil Blum

And you. generally of that because increases Got disease time, over progression?

Jim Fong

Yes. Absolutely. Absolutely.

look you XXX,XXX. than thirds when will counts time, data, less of about over two have platelet see at you’ll fact, In patients

Gil Blum

is about this I but quarter, and I’m question second you. a guidance? provided My decision regarding know Thank it curious guidance, as wasn’t to providing in gates what

David Kirske

Thank you, Gil.

to not provide We’re guidance. to ready time. at going were We this guidance provide

is one of let we’re the to publicly, at we’ve variable. as you Until about gross refrain gross providing still net at we’ll stabilizes, will factors the And know from spoken net moment. to somewhat the We guidance. is looking it

Gil Blum

Thank you. helpful. That’s very

Operator

Thank you.

comes Securities. Our from Reni next the question with of line Benjamin JMP

Your line is now open.

Reni Benjamin

the are like there to on at what congratulations into way be as what of do Thanks curious this from Adam, to I guess guys. you that and with the questions morning how reported I’m commercialization taking a next data required stick get to any label? ultimately the the like see for good steps, was the – Hey for I’d quarter. kind utilized ASH. company? being And effort? Is this would the right, to data ACVRX

Adam Craig

anemia Yes. the Well, first analysis. data all, post-hoc is of a

unlikely it’s data clinical the label. into So that get would the

the the it However, arm, be around ACVRX pharmacodynamic the to on. the is working mechanistic get that, and data, may possible label, pharmacokinetic and that that’s something team data

After the us, field interest that’s lot why who science Moving of the component science do people XXXX, discuss the have we forward, a team medical data of it’s That in we number is we liaisons. but a to of that we education continue can set requests can ACVRX it around not through actively And a had with we the the an we number promote data scientifically. the science and are medical we’ve that expanding are of that. of lot in – medical so can important scientific liaisons. our the liaisons It’s our of data. ASH, physicians to Jim’s discuss conversation able inbound increased and

Reni Benjamin

be of it you some provide of on additional to you will the said, to confirm be you really anemia just that’s just for study, Can be and won’t you just us reading forward let’s I tell increase the going larger the would of sort kind starting How been today? based would color? what MSLs – kind between just some generated in much data say benefit, want evaluate a the

Adam Craig

assessed anemia the benefit the Well, will in be trial. PACIFICA

was we’ve that give have Post number lot As amount with ASH, data. respect It very discussions for out to you don’t the of this a to anemia I activity and come how data. of and the a to have around in quarter questions successful ASH much interest we significant had a there. and into a with us,

So was scientifically. for it very productive us

Reni Benjamin

thinking my score? that a us thinking the talk have Got a then first right first because we they about just Can increases gross quarter? little you just and it. about with we to should we other resetting you like. And how Can to thinking follow be increased you’re about companies Only bit final price the question. how the to the the try should for as how as copays sense help net revenues in the patients quarter the give and of maybe to about be tend

Adam Craig

increase price end year. the a had at We of the

going we’ve for not progresses, year, not to that decision We do the number a factors of price may haven’t not rest consider. have the additional may And increases the – comment to It’s we on of or moment. a are the we year as made increase. there at we’re an price because

Operator

Thank you.

Reni Benjamin

just I wanted quarter. am first I about sorry, to know the

Adam Craig

think about quarter. you I first sorry, Reni, I’m asked the

well. time. our first But results are eight about year very weeks progressing in We’re start the be we we’ll quarter encouraged. to We’ve a good had and reporting

Reni Benjamin

taking the question. Thanks for

Adam Craig

Reni, did the quarter you I’m about sorry, first – sorry. of I’m or, terms in price you did increase ask Reni,

Reni Benjamin

a a delay more donut typically companies like was an I revenues help sense in because ruxolitinib other the like get there's hole increase to in trying Yes, we decrease just growth to patients, first the scripts. the to as to a drugs quarter with cover fill net try in there’s see

the quarter up there's some place. that dynamics So in of the just first interesting takes happened that lease because just

an that on I wanted get how and guys' might impact? to And insurance so from just your perspective, thoughts

Adam Craig

call. that we're first about about Reni, that We the talk today. Right. happy report can't to during Yes. talk quarter

Reni Benjamin

Thank much. guys it. got very You you

Adam Craig

you. Thank

Operator

Thank you.

Capital with Lake Street the Our next from line of Thomas comes Flaten Markets. question

Your is open. now line

Thomas Flaten

Thanks that waiting same questions. in characterize community are dynamic? or prescribers was that good you the well. patients could lines the have taking wondering exceeded those I of more number Or prescribers. Jim, side? for Hey community morning. number still that the the academic patient is mentioned the patients Has along total you of starts as – for you if

Jim Fong

Yes.

the correct. So dynamic, that is

in patient of we starts academic that the is So are in centers. community those seeing exceeding new growth the the and growing

So launch. we're marker of penetration that really it's a we pleased uptick really like a said, for product adoption and because about good new

Thomas Flaten

lower then challenged the adverse events? VONJO with any dose might in on patients be And comment prescribing Great. that

Jim Fong

Yes.

We BID. No to if the are but up is majority seeing that are frail dose doubt, of are the who're some of of there prescriptions that. VONJO XXX the physician, the of vast proper patients at discretion by-and-large

Thomas Flaten

pretty use David? David; was that then a end of uptick for And forward? one a going sequentially it. R&D baseline should Got in there is year, one and quick Was we Or new SG&A. significant that

David Kirske

of reflective is SG&A. in concurrent that mean our I investment

– to are marketing. commercialization we benefit, that forward in to it's invest drive as So using revenue as continues as well

Thomas Flaten

guys. Great. it. Appreciate Thanks

Operator

Thank you.

question BTIG. line Our comes Hazlett with Robert next from the of

line now Your open. is

Robert Hazlett

and on Thanks. I me. have progress, for the a Congrats couple

I Just, price the Sorry, increase you forecasting Adam. did you not that was? increases, are was how know around price much how say any year-end? But what

Jim Fong

this it is X.X% Yes, on approximately was January Xrd. Fong. Bert, Jim Hi,

Robert Hazlett

And there you. to of about think anemia strategy then or evolution regard is regard publication VONJO? of about to guidelines with with NCCN just should Thank the additional that we we broader Great. data Okay. kind be the as thinking of a kind

Adam Craig

latest already We’ve Stephen’s review, version data NCCN but data it’s be set submitted are published. and the final work some from actually submitted Yes, certainly. under will anemia once to the

we submitted the waiting publication submit for or on additional then it’s once last data. We’re published, year, based data can we

the modification approval sometime And with the potential of of we around guidelines do a momelotinib. expect there to midyear be

Robert Hazlett

anemia regard VONJO? digital a there IP Is Terrific. Okay. with available for that’s to

Adam Craig

I have something protection be to and that doubt provide matter will IP patent us filing, and It was – such. patent it, the additional wouldn’t considered for doubt will robust novel patent or have to would pretty probably it’s with we’d anemia of anything. year be [ph]. the extension term – five will composition data the is XXXX I take as that

Robert Hazlett

Okay. Terrific.

– and like for a work things Just know I Or regard saw Just would data to Are that a to or hugely Thanks. is little me. January is behind is in jump one data. There’s blunt various the more jump products kicking know in there there prescriptions more? we that at VONJO, that? metrics. anything in other anemia especially but a with maybe like material in the a there? bit instrument,

Jim Fong

you Do report? referring Bert, data syndicated are a what are what Yes – you different to? you have

Robert Hazlett

The symphony data, make And material data want of benchmark I that. that sales, metrics pretty data, show jump. like there just different is a various elements prescription I some manufacturing behind understand sure to the

Jim Fong

Yes, you’ve the momentum seen, we’re the of was end is think as ahead Bert, And that the already started to to I that momentum think started in the the seeing robust oral really that really But had already, of no our by I obviously, year ASH; – so we penetrate doubt created momentum today seen target audience. continuing. messages in presentation continue again, the as at QX. QX fuel QX

Robert Hazlett

very thanks much. Okay,

Adam Craig

Thank you, Bert.

Operator

session. Thank Craig like hand the to back I’d closing for Adam conference remarks. to you. question-and-answer concludes now This over the

Adam Craig

call you progress. the And updated for We call. appreciate and Shannon. thank now you, interest we to today. you concludes everyone, our the keeping Shannon, Thank CTI, that joining your in forward look continued on

Operator

participating. conference you today’s concludes call. This you. for Thank Thank

now may You disconnect.

CTI BioPharma (CTIC) 6 Mar 232022 Q4 Earnings call transcript