Lantheus (LNTH) 31 Jul 242024 Q2 Earnings call transcript

Good morning. Welcome to the Lantheus Fourth Quarter and Full Year 2024 Conference Call. [Operator Instructions] This call is being recorded. A replay will be available in the Investors section of the company's website approximately 2 hours after the completion of the call and will be archived for at least 30 days.

I will now turn the call over to your host for today. of President Vice Kinarney, Investor Relations. Mark Mark?

our Good me today you. our Chief Bob Jeff Commercial morning, Morgan, and CEO; and With call. President; Humphrey, CFO; our today's Officer. to Marshall, Medical are our Blanchfield, Officer; Amanda welcome Paul Thank Chief Brian our Markison,

second and then X-K differ to we from non-GAAP Investors website. in XXXX results We measures press forward-looking issued detailed measures are quarter is included will due and during uncertainties, our release, of comparable Actual SEC begin reporting the include for and the call which presentation during most filings. website. risks with section call call the Reconciliation financial the furnished call our measures. SEC section these Any a Form under to Q&A. certain which materially our our remarks was include statements. the release will also could slide The directly Investors prepared Discussions are open This to may our these statements results. made of this financial of a of morning, comments today's in variety the in GAAP

to our will now turn Brian. the call I CEO, over

deliver attractive business value Thank patient and financial and by the pipeline and we leadership a our of radiopharmaceutical to focused our and outcomes. everyone. sustaining clear radiopharmaceuticals our enhance maximizing while a fight outlined M&A, you, company of Last we purpose development existing to focused our innovative At and strategy better profile. expanding all through morning, strengthening are portfolio Mark, disease follow with good quarter, Lantheus, the leading to find,

of that positively to sustainable XXXX, DEFINITY share and our have and performance, I products impacted enable will products patients particularly lives We another led am than since TechneLite. commercial by and create X.X their operational of more million the financial delivered growing to pipeline continued the quarter families. strong proud Our PYLARIFY, long-term our value. discipline us beginning

Paul and will few You moments. hear more a just in the Bob from quarter about

commercial portfolio, execute X utilized pipeline and strength balance our transactions. Beyond our of we sheet our progressed to strategic the

our entered potential that high have candidate, when late-stage needs. imaging expanding beta acquisition diagnostic we a address with agent F stage announced of PET unmet We stage novel Alzheimer's the Alzheimer's diagnosis, monitoring. have provide two disease. MK-XXXX are pipeline insights of now clinical for late we a NAV-XXXX we targeting the assets and believe staging next-generation targeting and and to XXXX Most to early XX medical and we next-generation We recently, mix Alzheimer's complementary agent critical could candidate in imaging amyloid PET in diagnostic our the that F disease and space acquired XX candidates

pivotal is As disease. to options more a us become therapeutic new address Alzheimer's it advance time for available, diagnostics to

is of us take be prostate potentially potentially used expressed disease. This into We global could and XXXX rights releasing expression. XX% GRPR. to in cells RMX potentially as radiodiagnostic theranostic will disease Imaging's our and earlier areas. best-in-class to pair. and cells healthy XXX% in RMX pipeline clinical known Gallium the GRPR target also also prostate is LNTH-XXXX cancer and peptide receptor minimally overexpressed RMX and fortifies radiotherapeutic in Molecular lutetium and gastro pair RMX antigen acquired correlated the theranostic stages Life oncology or new of with stage highly

Life cancer to patients work believe cancer I/IIa soon expression, of as to no a having as In community. to metastatic initiate castrition-resistant with we could be PSMA low prostate practical. plan valuable study addition, this XX% addition cancer pair the to prostate Phase prostate theranostic to a XX% Molecular We the

monoclonal LRRCXX-targeted The treating to candidates of product from of two includes for treatment rare the broad radio is an a potential which agent cancers. the conjugate FDA designed potentially antibody, a protein with designations licensed we quarter, target and orphan highly this pediatric both the range microenvironment the Radiofam This disease drug is Additionally, and osteosarcoma. specific cells, first-in-class, from surrounding expressing theranostics. tumor

The second best-in-class we progress build and in candidate you conjugate, potential forward development. is TROPX-targeted out is to a radio advancing on which nanobody thoughtfully portfolio. our preclinical updating look our We as has to continue

operational now update. I'd turn to And provide to that, the like call to with over Paul an

by the share diagnostic PYLARIFY sales clear driven Thank PET imaging more quarter. details to remarkable patients sustained and prior #X standard generated the PYLARIFY PSMA agent year as from you, and than the health care of on another and million, PET growth for nearly XX% Brian. I'm net for utilized continued $XXX period, excited up preference providers. PSMA

PSMA available convenient continue widely for sales campaign, remains efforts, accounts among diverse as ensuring F we and to Clear awareness reliable Existing ultimately distributor enhance, demand PYLARIFY that XX our including PET grow that supply. agent accounts and imaging through only Be to marketing and our is network generate and referring PYLARIFY Let's the a physicians. continue strategic

payment to year been prospective system cost in transitional This of diagnostic TPT. proposes rule or Puerto proposed diagnostic the importantly, recognizes progress diagnostic payment pass-through access OPPS this radiopharmaceuticals outside Rico CMS $XXX hospital as field partnership. of and contiguous the for for the and radiopharmaceuticals, per than including European patient rule, greater now need separate payment expiry significant represents XXXX PYLARIFY. XX access. or administered D.C., with The of most has radiopharmaceuticals and following the broad day sustained month, for all U.S. through Earlier which Washington, PYLARIFY well outpatient states the value released our as calendar

XX% proposed are and opportunity a submit, payment November, have outpatient payment. or of certify XXXX MUC, separate would patients for insurance to potentially for rules. separate as ASPs. PET approximately final relevant in rates, CT including its in the would coverage restate procedural proposed in mean the unit of payment rule, In proposed maintain transition ASP date PYLARIFY traditional an setting fee-for-service CMS rule manufacturers future treated implemented hospital on Medicare the with CMS beginning a If in to be to the an the based PYLARIFY addition outlined at payment addendum or once B cost who

As to speculation in of see November. maximize to XX-day access we look midst are continue want on rule topic. updating and with final to the we limit further and we in Naturally, will you this stakeholders CMS we period, a comment the work when industry to patient forward

to proposed the sustain In with we broad and of patient CMS' to to our multifaceted strategy clinically we represents proposal continue separate diagnostic our CMS' differentiating continue to to will progress, This educational access entails commercially radiopharmaceuticals. codify parallel passage and to innovative legislation payment significant for since rule, PYLARIFY. promotional and And strategic support long-term further PYLARIFY's billion PYLARIFY XXXX. the addressable implement will through its to our efforts leadership key of customers. into over has solidify current entering XXXX seen These north support launch. to growth and significant PYLARIFY $X will by billion in beyond. and efforts we and adoption $X in partnerships market XXXX from expect grow

near opportunity cancer addition, be as positioned PET, radiopharmaceutical long-term conventional CT, cancer PET up of of and the first significant diagnostics. scan prostate approximately prostate Clearly, volume. scans, such bone for remains XX% In only to PYLARIFY represent and PSMA and making there blockbuster scans MRI imaging is scans, XX% with PSMA still well

progress PYLARIFY's our and market solidify to with pleased are expand the differentiation commercial clinical PYLARIFY's leadership. remain to and and fiercely conveying committed clear overall We

clinical be quarter DEFINITY success its strong DEFINITY's capabilities. operational year-over-year. With Brian second franchise's of experience proposition, in clinical and our continue continue noted, of excellence. out X up use R&D to of on continued including our $XX our its and million, with approximately momentum decades the to value team pipeline, expanding and focus drivers net sales XX% almost commercial cardiology build we transactions

his announced As new leadership our drug tremendous will May, has development and Officer, our and Humphrey, already expertise, Chief continue Medical pipeline. and to Dr. advance expertise oncology neurology in help Jeff brings and

weeks, study cancer primary our December the Within events to of with significant is its approximately the we in of prostate investigational XX% metastatic point PSMA-targeted Phase of castration-resistant III registrational patients the treatment reduction SPLASH, the with achieved or plan our radiographic overall quarter. cancer. reached in PNTXXXX share expect more data mature OS have XX% third that death. coming we In prostate survival therapy end statistically radioligand protocol-specified reported and In the risk progression XXXX, portfolio, a for to

of Additionally, first radio product to a the pleased could abbreviated accepted resolution that our litigation, candidate Hatch-Waxman for FDA lutetium it XXXX, neuroendocrine equivalent tumors. PNTXXXX, we dotitate. of making are application PNTXXXX the in and the launch new positive pending for treatment If approved the drug

need presence dosage unique aid among the amyloid MK-XXXX, beta the diagnostic future Alzheimer's and approval PET this in label, NAV-XXXX Alzheimer's as section confirm As the includes the pipeline. the of view for in prior administration need our the tremendous patients. addressing of amyloid the Brian for of unmet have acquisition beta diagnostics of antibody We to treatment. FDA's of positive directed disease. we imaging initiating The a pathology mentioned, to another candidates X recent to With all NAV-XXXX and expands

disease. diagnosis National Association staging Alzheimer's Alzheimer's month, Institute last Also criteria on for of revised the and published the the Aging and

disease may of both clinical biomarkers, PET guidelines an provide and recommend and defined severity. to biomarkers be indication principle assessment. its should a only diagnose guidelines the using Alzheimer's based used These including be disease and One Alzheimer's biologically main on as protein-based imaging that not of is that amyloid

about will to We Alzheimer's timelines pre-NDA over we MK-XXXX are the forward expect we Bob. to for in turn in MK-XXXX to at excited and the call diagnosis, an sharing and NAV-XXXX the look more I FDA held monitoring staging the disease. of and future. the meeting with in We aiding regulatory Recently, of NDA the a XXXX. pathways now and prospect for submit

results to Thank prior unless the quarter Paul, provide and morning, comparisons highlights good XXXX year will of I adjusted otherwise on noted. second with financials, everyone. you, focusing quarter the

last over of up noted opportunistic include $XX.X revenue increase seasonal the was entirely generally million, revenue Consolidated Precision strength was we've $XX.X DEFINITY details. along diagnostic and $XXX.X with TechneLite Highlights second quarter million the to attributable an of XX.X%, up of expectations for million, due sales, sales to of the Radiopharmaceutical net million XX.X%. with the at contributed million, line the of XX.X% of PYLARIFY to continued oncology $XXX.X XX.X% in quarter. $XXX.X revenue in XX.X% Turning higher. sales and trends year. higher

XX% decrease Lastly, strategic led product repeated expansion. tied by noted lifecycle of Further were offset PYLARIFY and headwind all RELISTOR-related management basis other not a mix sale of continues having the DEFINITY by of the million, MK-XXXX this mid to royalty invest strong due year. as basis overall and points PMF to PYLARIFY an to prior by network material from XXX RELISTOR last higher of XXX second basis previously volumes largely higher-than-forecasted was Operating our XX quarter approximate rate overhead expected of favorable from net due of as quarter PYLARIFY spending points higher for costs levels. XX.X%, partnerships offset XXXX point million down ahead the The contribution. clinical volumes, as revenue well profit in second the and benefits TechneLite due amidst prior development and company was margin expenses robust of year as to the a $X contracted revenue at comparable, the expenses and royalties than well franchise and were year XX.X% to year, $X.X Gross pipeline.

for expenses. functions. not quarter, was million of an increased previously evaluations MK-XXXX Other R&D profit in $X.X were to the increase announced perspective, notably expense to tied remainder and interest result quarter related taxes, and advance with $XX.X amount, for expense Operating $XX.X as million with to a amortization, is XX%. expense and at million this the intangible integration the the in our multiple quarter offset existing acquired interest of R&D income income in million transactional and our relating in $XXX of expenses deals to development loss the as well million other equity part of in associated the and forecasted stock $XX.X debt. or incentive of across expenses plans is investment of acquisition, income, before unrealized IP adjustments with million business quarter, respectively. and million Total nonrecurring by expense along $XX.X of $XX.X noncash of net

earnings the resulting was GAAP million income an second on Our was for net for the diluted of $X.XX The basis, $X.XX per XX.X%. quarter were quarter an effective increase XX.X%. basis, of and and adjusted million tax increase rate XX.X%. $XXX.X share $XX.X fully on adjusted an an reported second

Now turning to cash flow.

as PYLARIFY's CDRs. million, QX capital $XXX.X less the define expenditures, year. over prior which cash flow flow, when we paid cash cash of essentially million expenditures flow was totaled $XXX operating with year. $XX.X million, the Capital million we million, quarter flat last Second totaled the an increase operating year Free over prior $XX.X $XX.X

million July and in quarter, the the noting other During It to financials. worth the transactions that cash weeks recent the the company announced funded invested in we've NAV-XXXX. in $XX.X are of acquire use were reflected in not is QX

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

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

Now turning to for EPS. full year, the our notably the guidance the year as of adjusted well details as second for updated half XXXX some

have We continuously the implied year, of for second seasonal previously half revenue particular QX, between in and our are the affirming the patterns QX of view noted. to year attention we full the as driving

patient $X.XX be in regard months to which fewer range the visits into from partnerships split favor by customers, to with QX expected seen PYLARIFY expect our key more QX traditionally. begin revenue PYLARIFY, by deeper we net QX of will to to we a on have to estimate during grow basis, to manifest dollar billion grow Volumes full offset a on fully as As strategic we $X.X mid-XX%. throughout, revenue consolidated absolute the With impact an billion, revenue as the we driven year to continue reminder, with year. the go summer

will of EPS support structure. as did to into our we've view effect for account announced of approximately transactions the future $X.XX, within Our commercialization. dynamics for the near is weeks NDA we these Therefore, take adjusting not earnings as and last investments R&D basis guidance of long-term capital the to prior in adjusted we our MK-XXXX well $X subsequently naturally XXXX. Much of made year-to-year a over investment several an anticipation the on for the the of growth line are now and in $X.XX cumulative we to of anticipated filing vary as our account XXXX,

should million current and price Therefore, about of at our to to Additionally, for outstanding should the convertible diluted the be $X.XX. fully weighted XX.X second on and to in of a $X.XX the diluted XX.X model shares be per year. you the half fully million year share instrument, share approximately tied calculations based average adjusted shares earnings for debt range full

further all case PNTXXXX, year. for estimate does this has might not any business be include investment that development year, As completed been this the incremental nor any

deliver will Lastly, solid focus the you'll that our and future, we growth. from track note year sufficient year. investment away guidance In full quarterly to we progress guidance steered reflect to our color on near-term the community longer-term offer decisions the throughout to for

over With that, Brian. let to the turn back call me

commercial to maintaining diagnostic to you, market our billion the $X Thank Bob. of DEFINITY and Lantheus portfolio. PYLARIFY surpass in With radiopharmaceutical first track sales be blockbuster, and XX-plus on percent the continues value share, maximize

candidates, to we advancing and demonstrated current product our progress As the our quarter fully X strategic are pipeline. and through expanding in our second the of transactions committed

for radiodiagnostics focus that patient a can and will continue difference make populations. significant radiotherapeutics to We on

to Lastly, long-standing deploying continue performance profile we delivering by and our radiopharmaceutical invest resources to through sustain and portfolio for strong business capital our financial attractive will and in expertise commercial bolster our pipeline strategic development. an

the as find, closing, now to to are disease take continue your and ahead. we deliver better company. Operator, And fight go patient realize we focused will leading advance our to that, purpose and to questions. outcomes with follow please In innovation ready radiopharmaceutical

Mizuho first Petrone [Operator from from line the Instructions] question of Group. comes Our Anthony

on PYLARIFY quarter the on here. the the will two One me. will earnings And revised for questions congratulations guidance. be Maybe and on second be

from maybe that It level on will the to final in recommendation November. unbundle. late CMS like the was into settle There's pricing set seems get we to the how company viewpoints from the on CMS. period certainly proposal on So positive once a just PYLARIFY, October, debate ruling out

the and expectations and the Brian, big you Bob So level guidance. earnings MK set second proposal on but out final called in other season you to PYLARIFY? R&D. Clearly, costs maybe there. business in development question Brian, for here we've also learned And called -- step-up rules then into MK-XXXX, a in just out the what

the there. perhaps in I also is deal to there perspective think some exposure

So run forward? we on moving R&D? step-up just And this expecting should maybe the parts is in the the be going rate

questions. Okay. for the And thanks

into Paul the we're too CMS Before since to the here launches are avoid comment topic, period. we trying much speculation within

don't for the folks So we the -- rest listening Bob after EPS, you question. we're you in if But And your clarification the goes, will under, the going on on to line, do avoid will then Paul this mind. then topic. some answer of over

Thanks, Brian. Thanks, morning. Anthony. Good

CMS in the the that need including recognizes CMS becomes As the are subject was expiry, that noted payment final for those separate radiopharmaceuticals, of proposed outpatient we the forth rule put be setting. fee-for-service the diagnostic in maintaining patients would Medicare pleased to to PYLARIFY, hospital treated that November, namely value for pay PYLARIFY for separately If are diagnostic in remarks, traditional with prepared the TPT XX% of radiopharmaceuticals. and

required for radiopharmaceutical they manufacturers that PYLARIFY and Lantheus the or noted, continue does to important MUC opportunity pass-through. potentially report forward. could to off ASP CMS ASPs. mean is once MUC, of certify radiopharmaceutical in beginning are separate the indeed, manufacturers as utilize unit you based relevant going once It's on ASP restate not note highlighted cost have As or to, language, will submit, CMS many that to diagnostics submit do XXXX. not an noted transition proposed in to as CMS to And and diagnostics payment ASP

engage to continue this work patient overall As future not and midst CMS and for patient NAV going with in XX-day but the the industry of we in are progress a period, access Overall, maximize radiopharmaceuticals our products we pipeline, and to to stakeholders potential PYLARIFY, and Brian with Alzheimer's. diagnostic only significant we're noted, also like access. MK sustained have field in is comment of

right. All

think an Anthony, addition guide, NDA filing impacts of transactions, that, opportunity when the for in this in and MK-XXXX to don't significant a you so, about in to forecast XXXX. case, And naturally, we advance

vary ready a with over PYLARIFY time, As far added commercialize our XXXX, will actually with towards assets. $X.XX about promising be terms commensurate an we maximize on pipeline of types really with obviously, as it were take from expenses ahead transactions look in we market expect our investment as I of those opportunity. you investment number we year late where of return the were the of from XXXX, interesting much the to of investments well make in what and forward, do to your commercial, this sure like we you the investing you a will saw the curve right, to question go you're to perspective. number us own ability we as asset that do early that to dilution do be back But If And execute. we've eye opportunity the forward, able opportunity. And we as as to thinking commercial outlined

build attract we'll into things more on progress. color can -- as sure the make we'll give further So investment get community obviously, progress. that get out 'XX models as that and we overall and 'XX And into

question of line comes from the Rohan from Ruiz Leerink Partners. Our . next

trends your going this ongoing transitioning the to curious top an second potential XQ? from PYLARIFY thoughts half And accounts with curious might from growth are strategic the how contracts I your revenue XQ tailwind when also year? I Question behind one. what into incremental be was first was

turn bit. the it and start, I'll last then over I'll is this Bob, for Paul to and

And absolute so would seasonal and was very that also be be trends will, I'll that you in you split And broadened, if just color at versus sales, In I those seen which that's note Paul. how But with look specific throughout more more that remarks, line we our with would for QX, be in continue give have would were you you line way. historically QX than care. trends the across seasonal think peak we've to that growth, would QX be to grow health you think prepared much can in it I volume if will, in seasonal they but volumes year. trying with expect did to dollar I would then trends, to QX if expect terms it PYLARIFY of noted. you and I on my to about broader to But

PSMA clear imaging in Bob. PET the #X strategy Thanks, go all these to remarks, part the We market. remains beneficial PET position agent the other our pleased continue as to mentioned choice PYLARIFY's in even ensure as view Strategic remain PYLARIFY core our of progress. and and prepared patients, partnerships, with of these incredibly multifaceted key customers we to Conversations that a amidst that key to X customers with accessible competitors are partnerships agent. as sustain with PSMA well,

understand but don't competitive push want necessarily continue nature partnerships, on to specificity we the I we the why the business, of the Given around you'll these progress, forward. our think elaborate or we're progress pleased and further with to

Our Truist of next Newitter from the question from Richard comes Securities. line

MUC scan be you sounds imaging. wondering help be opportunity could piggybacking with maybe like bargaining nearer the term And market feel imagine into I was could then upfront, any Altares is if pricing, intermediate-term you going of off if I And your the to just the to multiples better say, in just clearly per would That's like to opportunity, patient for is relative much big or even focus. size could involved what question, with component a this way. about PYLARIFY? PET How a us I it that coming position. you last

were to CMS you fair conversations contracting You should you're a having observation? the prior the position in Is that the be proposal. better a bargaining with conversations discounting or than

Thanks, is by we're very what your we're answer but to encouraged last The question Rich. comment, seeing. Yes. no

in I'm placing the if the here. all fairly $X the and therapeutics, And an next-generation before approvals considered believe, that. And is front explode. we've Alzheimer's of to you of almost recent not innovation, beginning there this at agents going into at look it's field yes. to are to a at about recent Anyway, field, quoted two get back a very billion. So want be it. we're We're the it of with, meaningful TAM we bet right Alzheimer's excess to we that particularly or in best-in-class,

in them XX For academic XX are centers, and trials. of over country believe in I the in currently example, MK-XXXX top world. the is the

NAV, the specific and marker be most we that file. again, available So possibly beta sensitive tracer amyloid could once

going a So we're We're encouraged. highly bet the to be at when intersection and placing we're this market explodes.

Our the next line Matt Taylor question of from comes from Jefferies.

about R&D pricing Just can two PYLARIFY CMS that market? if wanted is, main little Bob, to bit and help the step-up going were the of step-up modeling transactions forward? about prepared do hoping could on between peers I is more ask One to your beginning next talk was on we the than the update the based segment out things updated you the see to remarks. for lower this the a year that ability And you our year of NDA the in R&D with and that parse MK-XXXX the grow

you the Paul, first part? want

CMS we incredibly So with the pleased we were proposed obviously, shared as rules.

the continue As mid-XX% earlier range. substantially a year with impact beginning at increases volume partnerships. moderating of contribution of The our the we by have in vast from each as driven year price PYLARIFY majority to it affirm we pricing some slight expect that this on grow strategic based today, to

billion. $X.X positive That's of billion relevant quarter the And significant for imaging, of are future if scans to PYLARIFY. of total only of if market commercial in to compared annualizing you and the led XX% a prostate second think specific we've PYLARIFY. place ensure of teams opportunity of to XX% differentiation expect with north PSMA as billion in through the is now our excited and then and this that you next call market grow. that. our and in PET is add We players led you we this of to about as by would the is right year still market look conventional addressable continue scans putting by there's incredibly commercial north to brand market by are end PYLARIFY's just PSMA prospects efforts. to this I at what PET to a that annualize $X the all think continue And expand, and that, decade. been we $X grow we north in The with to less to initiatives Naturally, generation number market marketing leadership clinical the of well and our expand cancer

PYLARIFY we so XXXX remain at grow, and number leadership this overall haven't positive and continue put will the very remain market but retain to a yet, we And PYLARIFY that on point will -- that its position.

just you the Matt, different pipeline. on to clinical with your question the about modeling if helping And R&D assets, will,

we provide probably of projected XXXX. on Where, effort, the filing obviously quicker will to less commercialization evolve things the I'll will course, would I an XX% going MK-XXXX. that As the NAV-XXXX to -- I totals, but the or XXXX. more kind color at closer change, will MK-XXXX it That when NDA look to get of of put really of as in on falls for get with balance sense we in RMX, that

from from of Cowen. question next TD Bancroft the Our comes Tara line

more hoping of a was into for your your I So the of little in what you And the you share? other maintaining years. explain in have assumptions potential could thinking confidence market What on your goes impact out entrants PYLARIFY share? bit there to

aware certainly for are the clinical players. Tara. Thanks, development other We environment of

potential in both that before. raises imaging. there we've overall, the commercially incredibly for take we outlined advantages, where that is competition and I has awareness competitive significant marketplace, demonstrate and the think broader clinically Overall, believe we seriously. foremost, We to new I believe and sustainable think voice PSMA PYLARIFY PET that, first

with I marketplace to PYLARIFY's demonstrated We position. informed to current have we we're make patients. so about the help superiority there product be able think to out positive in a And more leading what we're to that has cancer physicians able think very continue prostate decisions manage

commercial cycle as And product to and expertise anything so years in to we many continue in invest for space we grow you want seriously, life entrants come. our but to and to well improvements management in new to to Amanda, lead invest, . quite take this continue as add?

No.

you think I

line CJS Securities. Our Larry the comes next question . Solow from of from

mentioned if guess little squeeze just bit asked negotiations sort does market strategic change total your of have that of changed I at inroads is ongoing -- at terms you're initiatives two and a Are competitors Does and sounds doing way, there or about that U.S. or I another market? basically other customers? play all in your guess, mean is game and anything proposals Lucix waiting have a size on you just quick up now? of And any locking today follow-ups, to question, do making $X.X I meaningful CMS two in the it PYLARIFY. all? your may just said any the like you in. you billion, another in the adding I then that second way

Thanks the for questions. Yes.

As strategic our to game to best our partnerships. far We're people. bringing changes. more as to nothing We're product committed commercial plan, committed the

changes. nothing So

Anything on it. I'll aware of how let to concerned, does a far elaborate respond we meaningful, is point. Amanda competition it. As a that monitor little is and competitor bit as assess We're we we'll But look, it.

Yes. Thanks, Brian.

believe we that the see a imaging solidify clinical with reflect clear We clear competitors. competitive leadership is perspective, absolute market growth our with our our market with annual scans to since expand value we've seen revenue So PSMA our and continue PET in what of We've proposition. commercial dynamic launched. and outpacing continued will than market more from PYLARIFY XXX,XXX leader our leadership

believe And substantial shared market amidst during call PET In relatively PSMA remains in opportunity we overall, the share other market. remains X addition, in as the range, the our mid-XX% we commercial there a even growth competitors. stable finally,

shared Paul with scans market, addressable billion the PSMA are prostate of $X PET. by the billion market energy and earlier, conventional $X As TAM cancer and evidenced performed current you future addressable with of with number instead significant the it's that

our volume. PYLARIFY So market affirmed to range, and guidance the we by term, continue mid-XX% expect on predominantly ensuring near in focus leader. to And revenue remains driven to grow continues the the grow we've PYLARIFY in and

comes from Our the next Yuan from question Riley. line B. Zhi

PYLARIFY. Congrats commercial on of the progress

is in scheduled submission see XXXX. surprised little to the a are We MK-XXXX NDA bit

maybe indication thanks, share quickly So and with you discussed you And the for on this buyback would And was the thoughts what can current what and comment be target your agent? maybe clarify on FDA?

Yes.

buyback So you we'll comment. Bob, to with share want the start first that?

right. All

So start with that. I'll

think consider when we first capital elements. broadly going priority to be is business allocation, all buyback we So our perspective, from a Obviously, obviously, about development.

becomes You can the will see also to in pipeline. here that we have up QX. continuously as but it taken we plenty a us execute It's that we a dry topic continue full still those with Board, We of have appropriate. evaluate have and opportunities powder,

future. we the and about for the in held about MK-XXXX, to for meeting pre-NDA NAV We and to thanks sharing pathways submit And MK-XXXX we've the NDA with FDA, recently more expect regulatory XXXX. forward look Yes. and for MK in a question the timelines

Our comes David the JMP. Turkaly next of question from line from Citizens

X kind versus to -- PYLARIFY Maybe of like kind call fair explicitly could be you or that that I XQ just to on down get for assumption? Is at kind I of flattish appreciate commentary I cadence by look looks one maybe we want versus know even of Bob, mean, because maybe for But a seasonality out back XQ, right just in XQ the don't made could and year. it of the sort product. you the half,

From to into volume And look We do from trends volume from I going a overall hasn't and I do mid-XX% -- think given as it it, a into perspective, pieces we particularly perspective. think. as will a that fully to math, be the the our guidance our as continue parts sequentially, fair, -- see it these play strategic we've to key from we those come mean, to of you're I gross from mean at mitigate PYLARIFY But increase growth though more back half seasonal get perspective the a will changed year. customers with from those partnerships rate.

mitigated So throughout the itself of year. the view the balance really hasn't

So QX quarters for yes, I that two of be planning do will expect the the purposes. lower

of from line JonesTrading. the Our question Justin comes from Walsh next

Can there partnership? color forward you to upcoming any the on to like you provide And expectations readout? what your you see to with SPLASH POINT move your would convince for Lilly

as We've that control Yes. coming feel Look, be quarter. And this going data to a Thanks trial have question. but progresses, don't great this the it we see that the said for additional before. the timeline, exactly we will we're quarter. third

move best you move our seeing We the could what a when time. seen that's an and I tell meeting and obviously, our ahead. we're this year. we primary And of ahead, We'd seen it We're that's what we'll with know in encouraged like pretty Our the world endpoint. we've have. have to and the been with by already for at analysis expectation We're what the the is comfortable we industry And like confounding to is update endpoint. we now asset. what over primary survival something overall topic crossover

Blair. question Hsieh comes the Andy from next William of from Our line

just over us that's market, NAV-XXXX. product Eli the wondering a could potential guess, on decade you Lilly. I now, have approved profile from in if for differentiation I'm of the educate been

provide you a already how as that into wondering Just field of that has you positioning differentiation to of plan kind care. launch standard existing

you kick do want off or... to Jeff, that

you. Thank you. Thank Yes.

in it's as So III Phase for currently development NAV, expected.

earlier to higher expect treatment into amyloid clear and The and the importantly, and has pivotal of better detection for to potentially binding that less brain and We may outcomes. it of trials in and distribution, off-target specificity agent understanding bring images, potentially sensitivity anatomic allows earlier beta earlier that commercialization. lead the detection better through .

line Brookline next of Markets. Dolliver from Our from comes question the Kemp Capital

for and both to PNTXXXX? ability XXXX potentially footprint commercial existing your your is leverage What then

I I that's appreciate a it. great question. think

take to it, You Paul, or... want

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from building we're and built we I'd of points. excited what build radiopharmaceuticals, in existing to long specific therapeutics. a think diagnostics a in few strength our cover I And history and both position capabilities from

MK are NAV the and Alzheimer F both XX-based products. Within space,

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from relationships in and those hurdle that to we enhance And able build strength on in of all and which and market. that entrants can diagnostics, so others radiopharmaceuticals of delivery in that a know to be perspective, particular, we new for the that be position a believe comes from a and production

would PET agents, perspective, Those and the in imaging CT to From a scanned agents and would if country. scan already Alzheimer's capacity the sites be we targeting adding administered are where same beta-amyloid. for vast sites Alzheimer's, the both of at commercial we for majority be look those across to be able

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significant if opportunity, therapeutic Bob the has therapeutic lever. mentioned, investments sites in there sites, have at commercial From XXX-plus we about and a we sites with we that the we perspective, country, commensurate for but with those X,XXX treating therapeutic all of PET imaging. make about almost As could look PNTXXXX. specifically there's the infrastructure with there's do CT, Similarly, having radiopharmaceutical

as on naturally, physicians, that investments opportunity. we some the the oncologists with for but it that we already XX, would landscape oncologists radiation which we presence with the well to would be have referring as physician neuroendocrine PNTXX, treating well the We there the appropriate have be sites with we could PYLARIFY, and Again, relationships commensurate at make as commensurate medical would be already treating would lever like. investments infrastructure. for make able would be as And and so

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line question Newitter [Operator next Truist comes Securities. from Our of the Richard Instructions] from

margin, guidance is And rest. the right? that share It bridge step majority the we from higher Just most anything estimate grow I'm for of new else still the then of Does growth $X.XX-plus rest, next R&D in like around margin two PYLARIFY. think count, flat $X.XX. rate just is or if Or quick the assumptions sounds has year-over-year earnings of even you your some then reasonable gross I vast stand? year? PYLARIFY the cents PYLARIFY, the it wondering was follow-ups. about gross And sounds just think that mid-single-digit the like last to Street can your level. is up old that's Is there OpEx a a on with guide XX. I

in grow into your said PYLARIFY prepared future. continuing I in you're remarks, think to the confident you

So reconcile that, please?

transactions started we into hadn't sort of this of that spend, kind $X.XX, starting we we jumping forecast of you our Your do did When guide from because don't consideration that reconciliation off started taken is the I the in basically spot on. we acceleration say when that paragraph, naturally, the $X, R&D point stuff.

you Sometimes these advantage and of it. take opportunities arise

-- as R&D considers you've mathematical then perspective, count, share reconciliation the versus got in the a X -- which both as X. a the spend additional QX you're is majority and from what of well of right, and just spent So all that issue. is the And based. exactly But rest it we

invest in underlying of I growth yes, an again, than future our terms changed in hasn't operational additional So now our drivers. profile will us really to ability the into R&D other mean, pipeline launch that

'XX PYLARIFY be growing the to We're to guided XXXX, We've deliver mid-XX%. this year-over-year is first-ever we're billion sales. grow. blockbuster what that $X added highlighting this the north some Today, year to we're on right? of market with annualizing color has just We and the and to XX% able grew about quarter. maybe over PYLARIFY radiopharmaceutical be Rich, billion, almost diagnostic in about talking $X to potential at $X.X continue current and have billion

story XX% it our still addition rules the say, mid-XX%. a in XX% management. room proposed been only And well XXXX this of we place the CMS ample recent when cycle so the year-over-year we year, that a to with commercial momentum and first lead, specific grow differentiation, give there in half the guide to We time and life But suffice a guidance. support believe Naturally, to and to to that's continued be will positioned. to have further in growing be continue product we are and the

so And on and growth PYLARIFY's near- very we remain positive potential. long-term

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

day. and disconnect, wonderful a may have You