Lantheus (LNTH) 22 Feb 242023 Q4 Earnings call transcript

Good morning. Welcome to the Lantheus Fourth Quarter 2023 and Full Year 2023 Conference Call. This is your operator for today's call. [Operator Instructions]. I'd now like to turn the call over to your host for today, Mark Kinarney, Vice President of Investor Relations. Mark?

pleasure included turn uncertainties. Investors Discussions most website from and measures. and over Anne measures call today's our now Markison, will our Paul of Marshall, assume forward-looking to during our our in Heino, Chair also by the by strategic morning, this statements. materially. guidance today note differ except With Reconciliation XXXX. current and Q&A. and Chief to and we lantheus.com. open Good Please expectations press the may presentation Blanchfield, The measures SEC refer operational call to filings Anne's is discussion to obligation results. Mary and website. financial of law, Mary we Paul during results these CEO, applicable Actual provide and under It remarks, section Brian, could and any GAAP introductory begin if directly and call include today's cover are will to materially was our risks change and will the Board with Financial you. forward-looking Officer. for a welcome Please uncertainties. release our also comments statements the financial or and from the variety a even our of results future we closing Any Anne. that Exchange call. to a my quarter commentary Commission our Bob risks me full these section required the Form non-GAAP Executive our of due or to include financial results detailed We'll Thank no President; CEO; call XXXX year furnished Bob the Mary is update incoming updates for CEO; followed to these the and Brian made release, will in slide Investors which issued This Mary comparable X-K, XXXX Anne Securities statements, fourth certain of financial then at reporting for of call as morning, our remarks actual

and good morning, you, everyone. Mark, Thank

Welcome, earnings essential the started, flows, Executive be delivering as I particularly an science company's products leadership new able strategy CEO effective to It Markison follow was impact and March better of Before our industry. purpose it our great Lantheus, Brian in our used our important XXXX XXXX, cash families be the testament proud Lantheus, was radio X find as we Board in that and experienced leading disease to delivering we life the another at have to and strategic drive to understands our new were Brian. year million want work to and more position welcome Brian, outcomes. have experience expertise to stellar Officer, who in and patient get in patients that their deep so forward record to Lantheus done. will Chief me will on than revenues, of decades and deliver brings our and to a intimately And focused oncology the our bolstering we pharmaceutical that executive priorities. I'm lives He neurology company. X.

excellence solid the DEFINITY, XX%, grow of continues momentum PYLARIFY in revenue both with full which For the of XXXX. company year and respectively, operational competition growth strong remains confidence growth was value differentiated potential of year potential line representing January. amidst in will for this by remain the approximately early market for with performance clear PYLARIFY year-over-year even sales cancer reach choice. proposition growth and in growth as increasing leader a primarily of the and our agent patients, delivered PET offering year-over-year, that over reported PSMA prostate and and the ultrasound-enhancing with to of driven #X us solid pass-through agent imaging what billion give transitional XXXX, that, billion, XX% PYLARIFY $X.X delivered we remains XX% preannounced to well DEFINITY $X together This expiry. continuing

top Beyond non-oncologic radiopharmaceutical therapeutics III oncology oncologic line commercial across both results diagnostics. for PNT as diagnostics reported made significant XXXX. our In as for and our existing mid-December, portfolio, well and earlier-stage advancements also we as we pipeline late- positive Phase

PSMA-targeted demonstrating met development or trial MCRPC. the for statistically of cancer, of primary metastatic prostate XX% radio in in the investigational therapeutics death. significant radiographic Our risk endpoint, a its castration-resistant last progression The treatment patients reduction with or

to specifically survival are continue study overall this we review year. more data, results currently and awaiting accept mature the We later which SPLASH

For new our abbreviated our application, of product the treatment PNT and for the drug tumors, we ANDA. XXXX, filed candidate FDA accepted neuroendocrine or

under the Hatch-Waxman As infringement potential a expected, a triggered Novartis filed Act. stay lawsuit, patent XX-month which

important of very this equivalent look XXXX. forward the launch a radio and are excited commercializing lutotera about We to process in potential to

our and As the leading pipeline. to explore continually radiopharmaceutical focused company, expand opportunities we grow

identifying targets suited diseases. certain isotopes We focused complementary on treat are and to the particularly best that are

the in XXX to prospective label led RLT we exercised, options with alpha-RLT strategic candidate diversify and neuroendocrine allow I/IIa expand therapeutics. an of assets RLT alpha provides to example, announced Phase these for that recently our partnership and a with us us development. tumors options to As pipeline treatment radioligand therapy into our add If Therapeutics with prospective or product will pipeline currently

co-develop have we isotope-based cancer. led therapy prostate In addition, opportunity an perspectives for candidates to to alpha-generating

We are also investing innovative pipeline. in our diagnostic

a for biomarker patients Tawke Alzheimer's is being date, tracer XX candidates. To of disease it an MKXXXX, as progress therapeutic disease. with a used than of the identify enrolled more clinical staging in Alzheimer's trials in detection either be to in toutandles continue patients XX-based or as development trials to under We tool F to

a patient PET Paul. agents how has to staging to imaging patient finalizing play are pet as the With for path in and approved to product bring can staging this cancer, over that, turn to cow-based similar PSMA disease We now that MKXXXX Alzheimer's imaging I'll in market regulatory the agent. call selection exciting role treatment. prostate like for commercially believe a transformed we Similar candidate selection

you, and Anne, morning. Thank Mary good

Our clear continued PSMA excellence leadership, growth market imaging the and market. operational results overall fourth PET demonstrated of quarter

fourth PYLARIFY sales quarter generated respectively, over approximately and diagnosis XX% pleased prostate the that with patients of having XXX,XXX net since prior PYLARIFY on are been than more Both $XXX the periods. with in XX%, $XXX and XXXX, in staging We made year million including is success million cancer, the of launch. the living and up impact the utilized of lives for those and from this year increasing efforts growing of complemented network utilization with to PET by PYLARIFY were through at existing and growth access attribute PSMA driven to F-XX proprietary combination distribution customers, continued expand full our the quarterly by X PSMA-targeted our our demand. and and of primary success clinical we commercial factors: ligand differentiation best differentiation, operational excellence. our We isotope. to PYLARIFY offers believe Clinically, meet

clinicians management is a positive ensuring the high in of supply is and F-XX interpretation registrational agreement, predictive the demonstrated reliable decisions. providing agent widely and only network, value in confidence trials consistency accuracy Commercially, their distributor diverse that convenient and available Our supply. high imaging ultimately through reader patient PYLARIFY PSMA a image and

market maintain access lives customer-focused by and Polarify the PSMA XX% our of PSMA PET leadership diagnostic our industry's Operationally, led more promotional continue through in to PYLARIFY. with to team. market we efforts have covered the addition, educational than and In grow largest

remains and offer #X the To mitigate dose of best-in-class we working utilized also rate. We access providers a delivery that potential XX% end at actively the to experience health of in-full enables PYLARIFY PYLARIFY ensure pass-through a customer care PET patients with agent, PSMA PYLARIFY transitional imaging expiration impact to XXXX. the on-time are

choose XXXX beyond build market remain long-term select and have PET to agent of ensure they We as PYLARIFY PSMA choice. have their partnerships customers in access taken to have strategic and to and leader already and steps to ensure with we the continue preferably

We committed and leader. available to is PYLARIFY the market remains to are patients for grow fiercely continues ensuring

populations. of favorable prostate absence continue We radiopharmaceutical MIRROR enrolled ensure PET the study recently CMS, to of To first of create PSMA the Medicaid presence in long-term to to outside change whether intermediate to are Fine the advocating centers equity it the Services, exploring utility patient the determine while patient intended payment innovative prostate additional also for importantly, including work or PYLARIFY the staged detect growth, cancer and and we designed gland as in Medicare imaging management. seeking patients with health access Finally, PYLARIFY diagnostics, how patients the PYLARIFY. can for can accurately Act in diagnostics radiopharmaceutical for risk clinical or for to separate support we

scans expansion of the PET or current we to more shared into As we imaging. growth a need other realize XXXX. increase scans pre-chemo see approximately We is the by modalities, about PSMA cancer, billion other PET or PET To including PET addressable by year, XXX,XXX move of anticipate earlier for significant market could study opportunity imaging. intermediate and MCRPC evidence. anticipate population and market XXX,XXX hormone-sensitive PSMA lines billion of total addressable believe PSMA we grow this this, and for supported RLT $X would real-world PSMA than and favorable MIRROR therapeutics, the $X earlier therapy, PSMA will for the both which the imaging We prostate into both

to per grow the Finally, X% incidence prostate we of expect cancer and prevalence X% year. to

to the trusted lives which continue leadership. manufacturing of be study profile significant a our and with XXXX, widely December continued now a proposition year leader ultrasound-enhancing for facility, and clinical redundancy, Commercially, enhanced along remains its clear flexibility believe is high-resolution grow extensively Clinically, broad momentum patient our echocardiograms improve operational with PYLARIFY announced approximately trial market there its DEFINITY for have U.S. for top endpoint. available These from having cardiac full covered the with utilized our PNTXXXX, to we delivers the net III of production proven improvements, DEFINITY. The its to year-over-year. has success. demand this PET results DEFINITY primary by success our XX% and XX% strong line Operationally, and to cost. for agent SPLASH value we continued management excellence. chain the market business, than studied reduced which PSMA Switching drive to patient and million, at diagnosis populations. improved product drivers In DEFINITY brand sales met of as In our $XXX DEFINITY allows continue safety to opportunity that supply pipeline. As across and will access most and the up more of we such, in of commercial microbubble maintain its efforts increased in positive Phase is supported DEFINITY maintained Lantheus a for to ensure XXXX

this later data to We potential prior the NDA. year expect more analyze mature survival continue and an of to results the overall submission

the or to with conference. We gastroenteropancreatic future to results plan an a somatostatin targeting to the also SPLASH investigational non-carrier-added GEP-NETs, treat present neuroendocrine receptors tumors, potential at RLP medical lutetium PNTXXXX a Lutathera. as radio equivalent with is

with to that have current to estimate We improve complete Our therapy on FDA a to commitment expand we approximately the is that to applicant filed first making substantially patient ANDA market a PNTXXXX billion filing information, diagnostics. therapeutics $X outcomes PNTXXXX dotitate. accessible lutisium-XXX over addressable purpose is by ANDA $X of public XXXX. and billion U.S. underscores has expected Based this for our the believe radio for furthering Lantheus our through

announced. with pipeline, to In prospective this of opportunity. partnership oncology who late-stage about speak now we number hand I'll a addition have it recently over will Brian, the briefly latest to assets, earlier-stage therapeutics we our including

Thank everyone. morning, you, and Paul, good

Anne a are why about want forward. and I I about and partnership, the speak Mary excited the it's company we smart mentioned, As to Paul a strategic for both opportunity bit think more prospective going

X partnership Perspective Our has components. with

a First, enrolling license have expect option neuroendocrine LED currently I/IIa through the progressing later to tumors. year. look at we in XXX Perspective in dose escalation study phase, promising their Phase a have program is data we this an and to patients initial

may acquisition believe therapies Therapeutics transactions preserving position assets the alpha-based option in additional we the partnership behind for offer and recognize right therapy aligns with believe gain radiopharmaceutical pipeline our and collaborative and innovative chelator. supported lead perspectives by with innovative at it we concentrating platform one business last effects. a company strategy we and including target Perspective enable and more technologies capital first further We Perspective reducing of while third, cancer Perspective radiation promising technology. call key sustained the because long-term of allowing especially look third-party isotope an have that the see its for to at a the science I over to XX-month proprietary XXX, transformative therapy, benefits, thereby led We their This equity XX And target Bismith believe us of to establishing period. investment took the turn tumor with platform, off-hour codevelop the have our when transaction now protections daughters, later isotopes to for development retain as led secured expand to merger alpha paired our Perspective an prostate and growth. partnership to we the involving for potential provides this therapies, opportunities. alpha potential access to flexibility Bob. for We LED-XXX will any better Second,

sales of was quarter. fourth was increase a XXXX. financials, million was of quarter focusing RELISTOR totaled Sales over X.X% the XX.X% was higher during the continued from and achievement press with to will adjusted release, of year. up an year provide million, Brian, the XX.X% noted. year sales to Precision contributed of prior attributable for billion, as quarter $XXX.X XXXX the otherwise noted strength the good the Diagnostics Full compared year-over-year. over on $XXX.X the million quarter, morning. revenue the million I PYLARIFY increase unless year million, highlights $XXX quarter. in full as prior prior million, you, of Thank PYLARIFY of year oncology full of an results QX. for $XXX.X increase year higher an fourth of XX.X% recognized sales up we Radiopharmaceutical in prior and $XX.X the XX.X%. And sales were the of XX.X% DEFINITY year $X.XXX Revenue XX.X% over milestone Revenue quarter, $XXX.X $XX million,

year year DEFINITY $XX.X million XX.X% revenue opportunistic contributed were prior an prior down full included greater increase the down sales. comparable versus $XX.X was sales, the XX% million, that sales of X.X%. $XXX.X TechneLite the Full year. year, of For million, over TechneLite

MKXXXX's $XX.X year $X.X Lastly, strategic by contribution XXX.X% up the by partnership and million prior million, of further over performance the milestone aforementioned and primarily was driven RELISTOR other $XX revenue of bolstered quarter, million.

product $XX.X XXX to PMS acquired of be and pressures. associated the the and increase stock basis income similar gross organization, our expense profit intangible million XX.X%, as same for basis period incentive For for is amount, as of which quarter operating revenue. portion Operating points of and milestone. year. and other should made million ahead income for of of inflationary XXX when million longer-term interest and The expense tax an investments $X.X before margin $XX.X positions. of to indemnified Gross prior throughout the increase Other result basis. year in related margin over XX.X% points plans the respectively. Full of fourth a comparison reduction year. the of versus net prior last revenue and expenses over the income functions a RELISTOR mix of taxes. of purposes $XX.X acquisition, nonrecurring and at was previously Total by and particularly or near- by the is net of on contributed adjustments across was and prior $XX.X XXXX fourth XX.X% of support with was Increases MKXXXX the general year investments of million were contributed was expense uncertain basis offset removed RELISTOR $XXX.X full the Of XXXX of profit Operating year, profit for were on expenses an offset guided million, million. growth year was a remainder $XX.X this quarter initiatives all spending quarter the favorable noted XXXX expenses. quarter revenue the noncash XXX million XX.X% levels, a amortization, within than integration points reflect in rate adjusting higher XX.X%,

on per fourth income quarter year. Our an quarter XX.X% for XX% XX%. quarter period. effective increase adjusted net of the the fully of prior the tax GAAP rate diluted basis, the net on million earnings The were $XXX.X for on increase fourth XX.X% an respectively. for adjusted reported from and and resulting prior basis, the prior $XXX.X On year million an was was over year, $X.XX and of and basis, share fully year diluted adjusted share were $X.XX XX.X% the basis, the a per year earnings $X.XX an and increase full $X.XX GAAP an over an full

$XXX.X $XXX.X cash XXXX. Free cash expenditures million flow includes million, million million the as to prior $XXX.X former to and to less the expenditures, operating full turning Now QX flat flow, May. flow year payment prior year capital in for totaled operating Fourth quarter cash CVR effectively the than period which cash million was million $XXX.X $XX.X totaled million, which define Capital quarter. year, we flow. higher Progentix $X.X last as the with shareholders compared $XX.X

of Taken net together, at cash, equivalents restricted million. cash now and cash stand $XXX.X

to undrawn strong have $XXX We our liquidity bank with very access comfortable our revolver and position. are million

full our year quarter. the as for to now Turning XXXX well as guidance first

full growth We notably DEFINITY. year revenue expect with remain PYLARIFY robust, to and led

as slight other from organization volume cycle noted strategic supported DEFINITY which pipeline which We stabilization benefit PYLARIFY We steady of include support several contribution follow is net of commercialized our price make system, forecast portfolio. XXXX. the mid-teens from grow single-digit with due net growth, PYLARIFY relative and should revenue together sequential to balance PYLARIFY those predominantly high a the that projects. by efforts, with well advancing investments from will annual to trends clinical throughout year went growth at to management new the beginning life this important currently and products ERP as the across live advancing efficiencies among MKXXXX, drive

XX% full the from XXXX to $X.XXX an billion, RELISTOR result. to XXXX when estimate range of excluding to billion in revenue $X.XX we the be approximately increase XX% together, over year Taken of

For of we be the by we with select remain the mentioned, take of PYLARIFY's margin the of XXXX, potential traditional to modeling created line headwind inclusive with market purposes, in at our will pass-through XXXX, long-term profit year. continue customers. impacts considering as 'XX last And partnerships the Throughout even ensure RELISTOR to XXXX. end gross building royalty strategic in steps to beyond leader after Paul should expiration mid address efforts and by divestiture the mitigation

balances income noted Our well expected interest as approximately cash structure on revenue reflective effective projected the the be based investments to of to to and capital XX.X% the is due our our acquisitions. of operating rate and be flows interest as and in of nearly is strategy XXXX ability XX% are million to and sheet interest current strength expense expense tax to execute curves. The double to forward results, forecast providing significant debt Other rate balance and $XX should expected range earlier. XX% targeted be our growth Free on income and assumed cash of

XX for Lastly, fully $X.XX Therefore, in to per shares the range to we XX year, adjusted share earnings of the diluted expect million be be to shares. $X.XX. full diluted between million and fully

revenue million. $X comparison $XXX of to $XXX removed. of the quarter, Fully in $X.XX. diluted $X.XX or for results range that prior royalties again, be purposes, million first to RELISTOR the and in be per should For of contribution of should the should year-over-year $X.XX year range be quarter in approximately net adjusted million had share the And earnings

throughout XXXX full million $XX $XX depreciation purposes, approximately spread generally should modeling the the for amortization respectively, for and evenly year. year Lastly, and be million,

that all truly best. I call on Mary honored It years her last has of thank the Anne, for you wish player friendship. the over to back I'd we to alongside you, partnership X-plus employees, and And like have turning dare you. Before an worked behalf of been say, the and thank

stellar delivering was feel the about same you, Lantheus, XXXX partnership. I and Thank commercial performance. our strong year Bob, for and operational another

the the radiopharmaceutical moment expertise way would for our gratitude we to company, and and the Chair a I'm our forward express role earnings confident our I As to the has call, outstanding thank March Board resources say I X, Brian take like the to Lantheus want Brian. Lantheus CEO through of same assumes Lantheus. of are leverage for Lantheus I to advance now to role leading your to patients. pipeline. focused gone significant of Directors across future becomes X my all lead pass as on my and have to in bringing thrilled looking day Brian the my the I novel had will continue CEO, official of dedication. to of last work an position innovations continue journey am that we new incredible My deep to to heights in will capital as are and expand hard the organization unfolds. The to marks as change to radiopharmaceutical remaining your and significant you organization, This everyone and years at the tone lead during involved to

us on CEO Mary our about our with to led benefit now to I Anne, Having innovation With Anne. Operator, witnessed forward take established building transition of the serve. Mary for amazing leading honored I'm and for and our served wisdom to on purpose Lantheus. please excellence, we're truly a commitment the questions. patients. patients is that, the excited take the purpose, dedication the foundation and to team patient This values who on Thanks, great for unwavering shared and and continuity, of ahead. has ready this I've by go look strong continue board, role to and the we vision.

[Operator Instructions].

Group. be from first Mizuho Anthony question coming will Our Petrone of today

to as And It enjoyed again want you. through from I Thank congratulations to covering IPO great company here. Mary execution Anne. a say journey, was the

guidance for luck and with actually So our congratulations of next the model. XQ on guidance. in full and go run on the year also ahead the and I'll chapter Brian. a congratulations is to just PYLARIFY The start great

congratulations there. PYLARIFY A terms PYLARIFY. we to baked should And any for thinking That in lastly, everybody. in PYLARIFY the price, equation Are about question. anything for EU launch? just we there first little bit little the to price drivers help maybe So on of to bit volume again, And a XXXX? be scrub be of is what out then baking would in the growth for

you, Thank Anthony.

appreciate really I question. Anthony. Thanks, the

there did take mentioned a year, guidance, the formal and beginning the price in slight the growing volume next our driven volume then X% I speak price before for net took With well. we believe at for offer components to increase large of it WAC other and prostate year pricing is is PET de the that we room piece. to forward. that EU price includes that increase year. ample U.S. price beginning and being a predominantly market, benefit. revenue a on at last and to market. and do growth on focused imaging PYLARIFY continues We the the The as grow multiple we EU the mid-teens year annual and note, guidance going players value PYLARIFY minimis predominantly community to at the overall and this is on clear leader, So of I'll this most is would agents and cancer we with point. we This volume believe sustained PSMA to market and the by our expect as comparable

tack into market part it that And quarter, gives some obviously, the here decent Anthony, here just when point up the in just you're the this I'll how sitting end at on of And insights of at this sitting note at is February. shaping we're and fairly year. you the

hop dual PYLARIFY. settle FIND update approach thoughts I'll on out the timing and transition latest rather as we for analysis scenario on for No, expectations that's And the here out there's your and Maybe quick there how follow-up the Act, reimbursement, pass-through of on then helpful. CMS back And efforts one queue. can the just expiration around any status? in then maybe

Anthony. Thanks,

about status, PET of pass-through the agent. PSMA transitional So cancer losing available remain the impacts transitional PET XXXX. X will #X first the agents patients prostate utilized we whole XX% imaging PSMA in X of impact a To and before, pass-through ensure X of with noted as the months status we've as class

to committed PYLARIFY prepared PSMA long-term select ensure enter on the preferably year I into agent to remains as remarks, rules expect are proposed continues We ongoing over conversations to naturally, the to then of to with come in do access July, potential have to aware with work to have time them make of construct clear current PET we the out remains noted patient remains. if market strategic available access fiercely to but my them XXXX their impact And we continue TPT both with choice. to choose the patients the And for would ensure House to legislation support CMS continue leader. grow FIND introduced ensuring the we which Senate for so. and PYLARIFY the and partnerships Senate, to have, Congress been fiscal do the to that We of and they benefits continue has and doing Act customers and as continue understand in and

continuing market to But forward. naturally, on focused and the remains leader ensure defending, So that's we PYLARIFY we're the nature growing are. fiercely where of going

coming Leerink next of Our Roanna Partners from Ruiz LLC. was question

in pass-through larger dig more for wanted dynamic academic if with the years next evolving bit freestanding couple So imaging bit Could of And to might in the about you expiration expect evolve PYLARIFY. of PYLARIFY that between a you talk centers? little a and how institutions PYLARIFY? use

great a Ron. question, It's

freestanding to PET view center and government. indeed hospitals, PET into the X% imaging overall, of be and hospital, continue split So to PSMA been would grow. bulk imaging those centers the approximately roughly overall, Over expand distributed cameras moves and time, more pet we They XX% outside have freestanding equally the imaging relatively care we hospital outsourcing proportionately of across continue And centers. those. cases, that expect CT are as them. system to XX% trend some freestanding in

roughly business, X/X hospital, Advantage, unimpacted of as so portion Medicare as payers, or XX% impacts is be pass-through is would naturally which unimpacted. pass-through And their patients recognizing business transitional a the the of well that by status about only commercial within hospital which of

you're looking really overall their business. at And minority of so an

would we we expect continue think forward. the expect I continue to shifts centers business more so freestanding dramatic And imaging be in But to those overall important. to don't trends evolve with going

coming Richard be Securities. will Newitter question Our from of next Truist

And to congrats, chapter your comments. on Anthony's Anne Mary echoing and Brian next

to of you to pass off So provide If for things. more what start Paul. strategies in X I are? that on you expect One, mitigating And growing. you transitional those of you any just I you just that more can any Is can PYLARIFY heard on some there say due. color I mentioned, address answering the continue think wanted question, there's kind

there a pricing. and I to likely transitional is pass-through So just strategies be some for beyond impact in there'd that to as pricing commitment would growth PYLARIFY, some well imagine as

what, comment could if in 'XX? on as So elaborate move through if those of what actually just if impact going anything, as mitigating mitigating get mean? And then that you you on could year those some you strategies the would strategies

So the Rich. thanks question, for

noted and remarks, to partnerships we prepared select to they strategic with continue As we have long-term customers access ensure into PYLARIFY. preferably to do the enter in choose

patients. We for are available competitive elaborate is market, and to and nature remains the the on partnerships That grow to PYLARIFY given the patients market that don't customer means. further those fiercely committed that daily what basis, on point. to But want to of continues take the But this. leader. grow, specifics a remains that for market ensuring would of about I We PYLARIFY available are talk focused be and inappropriate we is it we and the are at on it ensuring this on leader fiercely continues focused

approximately market billion this to potential the growth, $X will we towards long-term to from with overall I year as As billion continue PSMA XXXX. plus expand the mentioned, think by growing PET $X

is to ample to opportunity continue grow. still there so And

the also on is a have that annual basis, not both quarterly noted necessarily We linear. growth and

focused and and on As as term become expands, grow. to we market new indications continuing the are long available the

is Our Zhi of coming Riley. next B Yuan question from

guys And guidance. XXXX trigger any talk those further about plan PNTXXXX, consideration? for point in clinical you development the is any see to there developments? the Glad on Can current

Yes. is We're Thanks the at we quite question. encouraged, SPALSH various closely the for in remain across, This that's Brian. and data, to continue watching look slices and of we XXXX coming frankly. the information

we take data going year, And a to look we're that see us, XXXX. the this the but quarter what Third we'll at right for direction. formal tells then think heading in we're prespecified

of coming Taylor is Jefferies. question The Matt next from

question follow-up us guess attacking the give gallium a just year. color the see in in are the PYLARIFY. any I Blue the market can ask how So dynamics most are seeing what competitors hoping you into of that and first on updated this on part us you was traditional competitive I I wanted that from there? could you you to take

Sure, Matt.

market So having used is been scans leader launch. than more PYLARIFY, the obviously, XXX,XXX clear in since overall, in

the over in PYLARIFY that's we from estimate past tide. and market our benefits the high note benefit naturally leader, XX% X, awareness competition PSMA range. raise have disproportionately with for consistent rising the X imaging of to agents quarters, revenue. been I now PYLARIFY market, product-specific mid- an share only players from Competitively, into do X report as the share more relatively the they would that come estimates As X as

XQ million fourth to that market both from potentially seen the billion, pet clear Importantly, market expand revenue accessible I've revenue $X TAM. And F-XX billion I as we're the on in XX% we've mentioned, $X growth sequentially, by the of focused, CAM would note to recently minimal XQ of and that factored growing that a to grew as grow the approved remains guidance impact to from quarter of left from a And quarter as both believe of expand patients, the our impact competition. and PYLARIFY, of dollar solidify leadership ensuring outpacing remains we our into where leader. there's we the continues is agents. to growth in the lot $XX is annually and by market, we Overall, with fourth quarter evidenced $XX well our 'XX, indeed continues where fourth million, therefore, as that year-over-year versus PSMA

from be Justin Jones Next Walsh of coming will Trading. question

and a about I interest I various potential commercial perspective. excitement the and imaging wondering tow PD-LX of around from SAP lot think there's if the on thoughts a of could comment you biomarkers. clinical was relative

and that, take there. on I'll focus and I'll So MKXXXX see we what

diagnosis that in a to to options commercial accurately that and the in clinical And application As really my And perspective relative it's kind being my a with then about to those PSMA revenue between and product. and clinical I Currently, said for diagnose used remarks remarks that perspective and when select see looking I'm over allowed being at for a I'll from trying start We from commercial trials. but what from represent that. then disease, of same available treatment are said, opportunity it's value value able I as forward bifurcate you a the see physicians was and here, see commercial potential purposely a the you step between trials, we really do for selection. were treatment perspective. imaging But patients. opportunity, you would radiotracers corollary in task really heard my remarks, potential cancer in with Alzheimer's big bring approved to excited which prostate used in who which we're forward we XX

And are us the and it course, our have engage, now what actively on. we about, regulatory really looking of commercial at not is that also strategy, so we yet that's announced FDA but with excites something

team you'll you'll more so well, talking And into hear hear about the but this that us, me, more not future. and

just I'll maybe expand Mary Anne. And

market specific this treatments the the share view $X.X market MKXXXX, and the we both Alzheimer's for ability and We of decade. that the on Just patient did selection approximately for market billion used be come by addressable end opportunities. earlier to to of as specifically staging the year

MKXXXX those And being so trials clinical to in come has certainly over be therapeutics with another with opportunity clearly, large to used XX an to partner opportunity market.

a earlier little agent, we bit development. it's Naturally, excited. FAP equally the are For in

about I of per imaging not years, think million scans X a potential But XX PET for does pan-cancer agents, have been over on We FDG, that around note which north market year. that yet. would we has put

market about large think you the if it's potential, So opportunity. a

Blair. from is question next of Our Hsieh William coming Andy

dig in deal. to the the can if about more you Prospective positioning. I wanted talk Curious strategic on

various You call. you on assets the envisioned that mentioned for

where thinking maybe what's site on length. that be the difference capacity providing we that a of on chain, generators Perspective be the before the will the Specifically, in or clinical do material there's also slotted will it post-lutetium setting path you think about? kind supply positioned? you Would be pretty the And should given And be long-term in trial site?

So I'll and the group, can then else that take in. for question add anyone

question where kind cancer the assets be can about these spectrum to of applied. of across I prostate think, the your first,

in SPALSH, to would which and us, post look yes. look That is is something are as help we being as I at right lutetium-based think would benefit because Paul we are say, believe these line evaluate best see where can say, they the exactly does learning all of kind answer trial, chemo, as at kind And versus to total moving benefit it PSMX, side the respect at I used. of the had receive ask in therapy with products really placed. we profile, be original relation of effect would VISION products as chemo look of in we You're agents. yes to might or have comments, I of, And versus products kind describe these the that products these safety the I of where pre the especially profile his then we're earlier

isotopes how application to I'll what perspective come than something good question. is XXX market. to we for to really bring decide applications to have on yet as lead the right about. one first that, respect these more in the With that something as have the So best a And It's been with them the their are public not option, based it's channel. supply say products we working now to we're to chain, again,

some either the It their on there, efforts that you website, to what manufacturing, the and of Perspective needs market. were that again, both, as it speaks option they've to would confident something or commercial that, in. market distribution scale And I of not regional specific to been noting, to the to because we kind either undertaken they we half-life, their have do we're distribution reach before information a already have of you're chain. you some got material depending can be or central is, on and that you've you You combination reference here actually get to is can website achieved. for But supply yet

just little to very to we're it we best-in-class, I I'll in to think neuroendocrine interested. And Their as that's the and close be that that bit. well. tumors think Yes. lead add us And has potential has one program very a

especially we like So like their the targets program. platform. We have lead and their like they we

Our next from Larry CJS comes Securities. Solow question of

to Great. Anne, CJS And good well. X-year myself. as We welcome. you. forward you to working look run congratulations Brian, a It's been with for And Mary

your math your you kind increases X revenue But is, And if the a more slowed about more where the is been midpoint line going expenses weighting right? some leverage? it a XX Or or guidance of looks It shake on sort modestly to margins the Just looks a a are question for of like this up guidance. that to on get has of then And increased on guidance out? a is it? question operating you little for for side? both you. the of material to Is in that year? my question little It answered. down the of part questions gross bit do of is with that margin Do building bps like midpoint of I the at XXX

That's the prior think of relator set you headwind. the should improved. the impact flat, a an slightly relatively about of be point maybe Margins right. of out if I Larry. But Thanks, XX great peel basis All out questions. that's royalty year, again,

we're product containment is the being flat So from manufacture to our sure and mainly to and we of you for increase. don't as increase on in we an to coming but remain contributing yes, spend that other terms is helping. AlariPy phasegating. have as campus overall And and can cost that's mix embedded in I well XXXX are that that expenses because actually And of in you you're able right, DEFINITY factors DEFINITY some make want that's an seeing spend, tell

that mature remarks, data and that we does put Street. data So investment will not indicated communicate waiting as to when make we Brian appropriate, before out, we'll as the to read in we're for make earlier investment. And further the Paul's or

of interest models, lot level under byproduct note see. appreciated of did the I look current think the there and cash we rates I significant. having and forward when is that of sort the on it's of is curves through another that I a the balance And driver the sheet consensus

I So job. million. $XX noted with of generate interest that Tax cash, team a my this good in scripted around level remarks, it of does does level that income

what's consuming opportunity same P&L, ERP. invest you efficiencies that's through expensive. pipeline. the in to opportunity taking as with company So appropriately to profitability our place. expand continue of down many But be the to a The our research, at job while workflow it that to be market But that creating kind of that the provide the things and as ultimately across drive strategies will organization, terms But those which time, can we've aspects does and aspects that much mitigation come I things cost. will development other business work market and access, opportunities think activities, whether all of our a like in with R&D continue company did fantastic protection that in as about also the our putting drive well clarified the costs of the invest Paul talked to business, for done

question from is Our Capital Dolliver coming Kemp next of Brookline Markets.

a a strategy that TAM little ultimately, in question GetNet XXXX indications drives and quickly what strategy for space the in My and increases detail? Could market the traditional in to because just you NDA XXXX indicated different net both the just Paul an between potential space. and to the you speak or then you generic the Could about had more data. PNTXXXX speak relates

to happy that. I'm take Yes,

ANDA prepared FDA. we we for market based remarks, did information, first accepted available X,XXX-plus an within And market real second-line addressable XXXX, as and actually with And focus on applicant. noted billion PNTXXXX, are GetNet. in the metastatic on that's we been the we we So that's prepared of one our of a on has patients submit estimate an which slides. public believe The has $X about about currently in by the

receptor there's as the for opportunity an As nets as potential we use as RLT, we've trial grow results the targeted somatostatin seen in believe as Para. market Phelan specifically recent to line in well overall from other first well of into expanded

you guidelines, And be there's out This class expansion. from years, would at of necessarily present in likely updates then is to prevalence. the use we proposed It and those, expand really look with so of and these. when a fortunately, change potential diagnosed labels. And expansion and asset driving really that this into just won't And which much is continue potential to what utilization. and more more men incidence as that's of the continued get women overall X the

we room And our and for about market be with so and overall, a in as we go-to-market multiple more view this get large luting PNTXXXX, potential opportunity opportunity players to additional as a certainly this we'll strategy XXXX talking launch. closer and

Securities. question David be next of JMP coming Turkaly from Our will

the of of mentioned long-term You ferocity some your partnerships.

things, they that trying So be then multiyear, to you up. be I a sort customers with have you to you these some what I'm them can just And they word 'XX. these guess can do sense get maybe of ask I to exclusive? sign potentially and can can just go contracts like lack of wanted of 'XX can that through and

strategy by and fiercely our I'm were We there. we amiable but describe willing very more fiercely said speak start I'll to ferocious. is partnerships two-way, They're just defend Paul let business, would we our going they're to but our not to what clarifying. as

choice remains that, those given specifically agent about long-term customers ensure by mean. multiyear the Naturally, their to PYLARIFY over accounts access, solid is customers in But No. into commercial deeply to ensure an codify I to very have not wait relationship contracts and nature and and I'm time number detail last years know what think, competitive question. I we going we of it. commercial significant discuss for experienced to incredibly go with But I mean, years. can't of key remain that that over appreciate the yes, the strategic we which team, enter working more market well that built And team help have until I'll into that of preferred national sales that overall together come. partnerships includes long-term these relationships experienced we partners with

considerations be chosen exclusive, a is retain reference because the role partnerships to these strategy PSMA-based space made also the choice and in whether chain chain would and radiopharmaceutical of exclusivity for PYLARIFY's our just to it supply very I'll supply add for imaging. atypical to market-leading you most products, just and were the ask these as for

question of from final be Newitter Truist Our Securities. of the day will Richard

have one just cycle a has type curious publicly competitors FDA. the get past transitional one I it favorable pipeline I diagnostic pass-due product through cycle talked kind the strategy? life promising, any have expansion, Is product restarting but On additional about more you can expansion, offering transitional the even life intermediate just sounds the one. approved indication possibly to you had your and management, views for and of in MIRA appreciate due, next-generation clock I'm if on management there that study if this indication of concept. beyond the specific anything

appreciate it. Rich, going on comment competitors what said. and other We're No. Yes. the I of understand have not question, publicly our public to companies

we study you on focused is expressed MIRROR cycle are As noted, in as by as cancer management both assessing life tumors. solid other the with well PSMA PYLARIFY, its use non-prostate because

primary supporting legislation. ensure CMS as to For with regulation of should we focus really the agent specifically work that legislation customers work with engage remain preferred Act as support then FIND the naturally to and choice to then well pass-through, our is to support with to CMS and

to market continues We grow, that grow and clear and We to it the so PYLARIFY the the believe And ensuring cycle life patients accessible leader. large market. on and continues on market focused comment not have competitors I'm stated to going clear are remains management. PYLARIFY publicly what then about their is to believe it we remains is

today's time. Ladies concludes this for This questions Thank no you participating gentlemen, the program. Thank at further conference. there you. are and in

disconnect, You may and day. have wonderful a