LNTH - Earnings call transcript Q4 2020

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Operator

Good afternoon, ladies and gentlemen. Welcome to Lantheus Holdings Fourth Quarter and Full Year 2020 Financial Results Conference Call [Operator Instructions]. This call is being recorded for replay purposes. A replay of the webcast 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 30 days. I'll now turn the call over to your host for today, Mark Kinarney, Senior Director of Investor Relations. Mark?

Mark Kinarney

Anne afternoon. open XXXX Lantheus With our Financial today's business are good and Fourth me and Chief and and update, introductory call Year President remarks Anne Full Results Mary with Financial you, Officer. Welcome Bob will Holdings to Quarter on CEO; Mary Thank and our remarks, begin Marshall, some Heino, Conference a Call. furnished the and release Anne will for will results. conclude our and and year cover then Commission with call which Securities fourth Bob afternoon, we'll then This full reporting Exchange Mary XXXX closing call press Q&A. Form we to our the a X-K results. under quarter and financial issued the was

the find of release section lantheus.com. at can our site the in Investors Web You

I'd Anne. the measures tab. section our now that, of in or discussion my statements, most we presentation Please under during to Investors the those of results to of Reconciliation not For in Web site. Mary change measures. required expectations call before and the this that directly you call But you include to as we Investors except to uncertainties. the forward-looking for can applicable find financial forward-looking measures our will Please no a slide webcast, started, by SEC statements. of our comments section note like non-GAAP certain Also, website Presentations remind during of you the even on get refer those outlook include may included will these these pleasure filings the estimate on detailed comparable particular, by to assume actual financial of date. GAAP today's materially future that the on also impact update available call the over to the from results uncertainties. a indicated risks materially. With law, best if turn results it's obligation discussions Actual to continuing forward-looking risks statements In business is our as of our this COVID-XX is variety of a differ and due and information based these

Mary Anne Heino

of afternoon. families well call. hope and you this as finds Good and listen you this to I safe each your

strategic challenging all navigate part and latter employees, Even demand. will disruption.Lastly, majority into to of drive care Progenics' important the we our through partners the team pandemic, continue the and our and even what to talented remain of the we and remotely. in work we worked employees merger employees, health hope and other of notably COVID-XX own also for the behaviors is no successfully with at the navigating we As reality pandemic. the distribution last daily approvals closed balance We safety of we transactions regulatory community. the we into In a XXXX, patients and future. as our secured business for the year times supply health committed several workplace safely remote of number adapted successfully through very product of manufacturing exciting business of the new We with quality our brought these the to seamlessly sustainable we most global backdrop our partnerships, and our chains Progenics, portfolio and a integrated against with growth unpredictable and teams which challenges, operating complex product believe and

hospital and accessing vaccines normalcy health seek will our of of to will this system. to by of population year. to care administration these that hopeful all lives general new patients' pandemic continue that in access impact willingness care have confidence part only the recognize availability vulnerable we to XXXX, restore and populations not frontline vaccines, the but workers XXXX true in in on parts We're the during and of the first and to encouraged an forward, Looking

our encouraged We and well will are our hospitalization commercial franchises seeing you trends by Today, our rates. falling as corporate the on cancer key cancer and portfolio. services and traffic within I are lead Lantheus PyL I'll group. update case we the hospital also progress pharma our our launch. be year with in data commercial prostate with prostate potential in PyL, currently FDA development product begin XXXX exciting our an with and portfolio, approval the of as for will

margin prostate priority expansion discuss We the patients the believe PyL designation first to have FDA the of revenue approved, down growth the to F-XX time time cancer PSMA-targeted tech from currently an prostate it lives meeting positively imaging will of priority for May sustainable The agent, drug or impact from of -- PDUFA membrane to acceptance, accepted The committee review a PyL, to months driving is review standard XXXX. we the our NDA application agent. If of hold with an the FDA months. date labeled shortens action The also assigned and review advisory cancer PSMA-targeted new for for available U.S. to the that opportunity not be Lantheus. prostate-specific antigen, application. while XX, commercially diagnostic PET and FDA's time review six the indicated planning XX NDA

to inclusive population. cancer an of one PyL investigated appropriate safety the is be studies men second Currently, studies, cancer In there teams. fronted common medical we and the out and disease his Across and in has more of studies. preparation metastatic commercial studies with two studies, prostate to is subjects or imaging PyL We Our been designed prostate an for is multiple company management. a diagnostic PyL form administered by PyL launch, demonstrate affecting these most disease the for safety building reliable the profile. shown diagnosed approximately two our enable cancer, imaging establish reliably from Prostate also patient cancer the our high-risk and PyL States. lifetime. two collective need in the in of PyL targeted has attractive in cancer supported will III detect United and globally, unmet believe men localize CONDOR, of in company-sponsored recurrent ability X,XXX data from sponsored We NDA eight believe and our performance results particularly in significant the these are OSPREY prostate agent estimated continuum. across Phase both

manufacturing marketplace working We facility, PMS, so channel of the with are PyL could after of also availability PET or broad US launch. goal that our to we the reach soon

centers to awareness with of those oncologists addition, products are urologists, PET working who as are PSMA used well groups patient medical imaging PET these with as In imaging build where oncologists the radiation and advocacy order we products and generally.

prostate to is team lives make the and of to diligently our are PyL cancer We patients, transform fully the committed of working to happen. potential this

for for mid-November, our the others global indications our now an offering and product to an require of lumen or it applications DEFINITY give to market-leading to suboptimal portfolio. patients years. supplemental that inclusion echocardiograms products. our for temperature partners are commercial trusted right, kits RT franchise echocardiography. have include Turning joins commercial SNDA, XX nearly key formulation. expanding drug product doesn't DEFINITY Because our application, the as a DEFINITY in micro on elegant FDA-approved outside room I'll RT, and and developing our pictured customers on our is for update enhance solution multi that new our refrigeration, here RT In DEFINITY,

in companies complex evaluating are of room collaborations microbubble temperature components vein will and Incitec. formulation glioblastoma. of microbubble new speak applications occlusion services. healthcare and me temperature These also cerevast, These room including of having applications, today and heard note Cartera with retinal and multiple important delivery Vialmix our our product recognizes product offering. part indications a need You've and an portability increasing I be will for their the overall in are the

and lab ultrasound new in in applications currently reserved emergency are While transportation research being intervention DEFINITY for for to part echocardiography with acute patient in of for image which traditionally enhancing setting, treatment treatment or infection, begins a center. myocardial have agents instances settings. the been both during ongoing is use an stroke explored

the of XXXX. a has patents, book We expires offer trends I DEFINITY. now note five supporting patent, a in RT which in quarter. intellectual DEFINITY continue procedural in invest volume brief fourth DEFINITY also will matter composition the Orange property about listed including to

with with some the of in volumes drive DEFINITY growth December largely work sales declined. over tools. with see prior trends of resurgence October awareness we While Bob in procedural however, DEFINITY of using engaging echocardiography line to virtual will customers, speak so team we DEFINITY are seeing doing non-urgent to results expectations, use our in continued to late epicardial period as and decline actively periods.Our during brands, with did associated appropriate our in the this COVID-XX volume were November in suboptimal specifically predominantly the remotely

products. an build for update sterile our facility an vial similar on to offer DEFINITY I'll Finally, in-house and manufacturing project

manufacturing approval, completion us finalize that SNDA steps important submission continue work batches. qualification for FDA moves this This still which the we completed preparations later have our with FDA to our the year. expect We to our of of closer

Moving now our Radiopharmaceuticals to portfolio.

note, Our business overall performed Progenics by manufacturing our on moly their so navigate benefit the our global did ensure and successfully our temporary portfolio with growth limitation supply a basis. Contributions year. three in XXXX our flight access acquired minimally fantastic we our quarter, for generators continue of and sales a were the over during changing a logistics logistics turn, to and that sales AZEDRA margin to supported impacted. Throughout so well grew patients Technelite profile. in the hospital supply in and ongoing to of customers team suppliers.Our part the international Despite receive all our Of prior partner, dealing to complex chain we that, from job representatives. quarter, significantly continued from

for we That's prostate who II asset Anderson, we continued at and We will products. our oral fourth market XXXX, which speak in encouraged be hosting and ensure an end important believe our an manufacturing only for based reliability In capacity is exists continually of the annual to the quarter iodine who and as tumor improve AZEDRA XXXX. goal in discuss XXXX meeting of FDA-approved biomarker paraganglioma. later, of late will received pheochromocytoma response an plan the presentation therapy also AZEDRA. AZEDRA, iodine the for an cancer by March, Jimenez MD of I are To implemented patients for for Dr. efficiency utilization by will we based manufacturing opportunity iodine Phase pipeline more us

point in also Bayer, a most in who therapy. imaging partnerships We is determine our potential progress we are can pharma used their in in discuss trials. ligands in companies Pharma The but point inclusion to illustrative therapy and development. of strategic expertise potentially with PyL clinical the drive assessing portfolio. lines these use selection have our overall could I development a both imaging utility expense, quarter, revenue shorten studying biomarkers strengthen metastatic into announced that patient clinical for inclusion in In by and In new in agreements reduce in belief These biomarkers trial biopharma's We in monitoring for selection potentially castration-resistant the as through risk, our to like will trial clinical supply during revenue and clinical time III valuable see partnerships development entered Now avidity agreements with appropriate PyL PyL diagnostic we with PyO collaboration have III commercialization agent partner. companies created can which these a in December, disease services the and as prostate services the the Phase PyO clinical relatively to clinical the benefit patient PSMA next-generation optimizing with for patients Biopharma. strategies Phase development metastatic results obtained.We cancer. to the PSMA-targeted in reduce early our trials biopharma's product, of oncology business. for generated just potentially to response pharmaceutical or not with data include reinforces elsewhere of our Lantheus drug value trials, in a be stream from I'd To radio partnered business plant cancer. believe Regeneron third their provide which to using access and selecting be prostate

to challenge are forward pharma a NanoMab technology immuno-oncology we master with in in the and drug IO business imaging PD-LX-X the May for late therapeutics, biomarker. novel Another academic Evaluation FDA using begin from a a of pleased PD-LX take to announced trials the making XXXX. clinical services step a key with a available We therapy companies clinical license filing Limited therapy. developing potential biomarker development patients to biomarker for IO new centers of occurred in we of tool I-O in pharmaceutical the companies optimize selection providing in or XXXX.This research is our an January, is in for for file will with important and MM-XX,

entered into of important PNF we our an customer Pharmalogic core long-term January, activity. US and Lantus' financial logic.This agreement supply at early will an the the relationship in strategic pharma our them. Puerto lites agreement, Rico pipeline. update lamps Puerto extends Radio in use with on provide our Pharmalogic transaction Rico Lantheus us our market closed a to to Bob will entered continue which December, is transaction and in this allows M&A sell end the Pharmalogic supply The model Lastly, distribution businesses and to In radiopharmacy under I'll proceeds products. product invest and to the and and transaction with Pharmacy into to details. simplifies

enrollment our trial In XXXX, development I-XXX the Canada. of With based PSA treatment February, presented trial. ARROW to the II that, Clinical and and this key research We're Genitor I'll stent targeted Phase the we prostate have a pleased turn in product abstract our patient programs in over of GU, study castres call is with sites Virtual Bob. strategic Society XXXX resumed our cancer way American Meeting Bob? active to my candidate in study on ASCO Progress now In under or pipeline. metastatic Cancer on conclude highlighting U.S. for and again. commercial the Moving trial. Oncology ARROW October update the we to and at

Bob Marshall

of organically. unless good otherwise quarter with in X.X% portfolio due a late was from since COVID-XX for year-to-date X.X% X.X%, a $XXX.X or in sustained fourth as until X.X% was DEFINITY Technelite decrease Revenue an to and was year discussion adjusted Progenics the from quarter the quarter second during to sequentially effects million $XX.X largely prior the the and Technelite of of experienced DEFINITY the afternoon, XXXX. offset quarter. revenue fourth grew On Thank mid-December, was the year the on of of $XX.X similar quarter half quarter, but prior noted. X.X% my up $XX.X compared you, partially on Marianne over million, of the Sales quarter strength revenue basis, million, the a I as year DEFINITY XX.X% December. in quarter. sequentially, the customer and the results described focus will Maryanne, pandemic of higher of X.X% third million, a increase prior everyone. the higher volume earlier. contributing decrease latter demand dynamic

Positive DEFINITY fourth a margin higher and or Ansto, related the to $X.X $X.X essentially As to Rebates increased amount, opportunistic the XXXX. newly $X.X million. and including million totaled points fourth $XX generator assets acquired as was Year-to-date, million intangible company Mary sales profit $XX.X Ann quarter fair recorded to value with of the tied G&A decrease noted, marketing the Gross Progenics efforts profit same compared acquisition XXX the to operating sales the of XX.X% in R&D impact value of PyL addition flat resumption XX.X% synergy for period some totaled the a allowances from plans $XX.X and consideration is launch reduction the quarter and to contribution additional QX basis quarter. integration of of in related nuclear, XX% patient $X.X mitigating portfolio COVID-XX related million. raw was our onetime from of X,XXX Xenon net Other quarter XX.X% Operating CVRs. issues. down as changes net Somerset and filing PyL-related expenses for Daripa for of during PyL. by a revenue $X.X tech initiative noncash Operating well the fee stock to million before to profit materials transfer with versus relating of QX. of from contingent to sales $X sequentially quarter million, by quarter relatively was Both the and approximately is taxes. this enrollment as in-house the of process in course, capture. due prepared revenues associated from amortization Of a rights net as of facility. as in that improvements fixed commercial An $X incentive or of XX.X%. investments as associated Progenics NDA the our Adjustments million lower the reflect included decrease in third year. the Noting, with well and XXXX quarter expenses embedded. and were achieved prior million was lower ongoing offset period $XX contribution cost manufacturing the related and to million of well the for savings the synergy unfavorable expenses and million acquired contingent million as and was

IR&D relative the our advancing we remain to due important to XXXX prior quarter. certain management AZEDRA to to the due which AZEDRA recorded months. during with Lastly, impairment expectations life had value spend the Azedra XX relating R&D to $X.X cycle management life enrollment million is during to the of program This during rephasing X near-term of of opportunities to cycle XXXX, next maximizing and committed from asset. We this initiatives reduced COVID-XX

reported $X.XX effective a $X.X compared of a adjusted earnings and Year-to-date, discrete $X.X an basic of GAAP underlying profit in and fully the a to share rate. fourth an earnings interest GAAP a year net these is we the basis. the on indemnified. levels were are loss for XX.X% $X.XX tax by and period. a rate basis, profit per net an the adjusted compared and fourth net basis. The XX.X% associated of tax accrual period. quarter was million for items, the $XX.X diluted of of a the fixed profitability million diluted income prior with profit per of was share loss XX.X% fully and a a and certain effective the Yes, quarter an were accruals of basis, $X.XX our million Our and When resulting Year-to-date on with taken on of elevated of decrease are reported decrease was of which the year basic in on million rate of other uncertain prior $X.XX tax result to profit net positions quarter. impacts loss $XX.X driven together adjusted loss a income a adjusted

operating million less million, quarter million $X.X totaled cash cash which flow. $X.X than million quarter. QX income of cash in cash operating use capital the Free $X.X to $XX.X expenditures, $X quarter. the the flow, $XX.X Capital period. of a the turning of Fourth flow main Net differences variances as from compared net drivers expenditures prior a prior XXXX. in the flow a was million to as Now as less well was were we as define capital year million, decrease working decrease year

on efforts continue diligent we making stands equivalents focus to at our $XX.X net Cash Importantly, driving restricted sustainable longer-term million. long capital of now deliver cash working and to prudent growth. management cash investments and

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

We and that We as expect create patient the broadly. are so more impact Now this lingering hospital resurgence turning believe in to diminish on latest vaccines less to QX XXXX. resulting could behavior and in and of pressure impact traffic distributed QX. revenue COVID-XX the would

$X.XX diluted profitability. to share As million ranging in will a to QX be from in PyL such, investment commercial would adjusted expect range flat. to Accelerated and $XX earnings we near-term a million be revenue $XX per of minus impact readiness to in loss

consistent cash review generation However, well profitability commercialization, the and as recovering half the business with accelerating free second PyL priority timing, year. both project as we assuming base of flow in with approval a

the assets. our end million full Puerto of the of per Anne full that of January with both assuming As stated, Puerto targets XX, of end, Mary a approval year, $X.XX XXXX. considering and date as PyL the the earnings $XXX adjusted range see $X.XX, the the To range, we as we on $XXX adoption about fully Rico share in to Rico our we million sale closed in year operations revenue sale of near QX, broad vaccination PDUFA think to diluted

from Puerto net million, mind results and $X.X For keeping the of and diluted comparative EPS adjusted business reflects generated XXXX of XXXX, EPS Rico of purposes, $X.XX, headwinds income $XX.X net GAAP in million COVID-XX the during stemming the revenue both pandemic. fully that

EPS purposes approximately XXXX, of should the Looking sale for ahead operations the and $XX models. adjusting to revenue XXXX, of in Puerto for netted the to place net new owners in of $X GAAP of million your the of agreement remove put we These $X.XX results models with income Rico fully operation. net financial of our you million and diluted for account and are supply adjusted from have EPS

single we Rico year have Additionally, generally the in digits low modeled for Puerto for term, growth the longer each the business.

P&L the our of find website section can You Investors financial XXXX in supplemental under a copy on information. the

Lastly, range me be for With weighted to outstanding full for amortization and million, the Anne. shares million fully over average be call million and the XXXX. shares XX approximately that, expected back should respectively, let $XX of XX are a million diluted depreciation to turn in And Mary to year. $XX

Mary Anne Heino

growth, transitioned Thank like of the near never the close exciting challenges, look was the pipeline. staffed our Lantheus patients we safe of saying and now PyL be promises our I sites, in each proud virtual to the the advancement to the them to well approval XXXX you, I other an and launch for year it am we Lantheus. of pharma end would an for I am as Bob. QX, sight services businesses across seamlessly for who that to other. came as ensured company. continued mission our employees do and employees manufacturing of lost opportunities commercial by for so many routinely efficient call so, to We as the that our that of employees but grateful team and who faced XXXX so how together to

are and I With look commitment on the remains take ready now questions. forward your As always, our on go Bob judgment to I ahead. you accomplish all investment. Operator, that, to to please progress. good this updating with

Operator

with Your first Jefferies. Petrone of comes from Anthony the question line instructions] [Operator

Unidentified Analyst

potentially Doug monitoring through prostate landscape This is for you initial for screening after radiation? the Can the surgery PyL for just on Anthony. how patients indication walk shifts or and

Mary Anne Heino

you Can up. was that little question? a It repeat broken

Unidentified Analyst

walk you screening? for PyL landscape through prostate shifts the Can how cancer potentially

Mary Anne Heino

for, but of what populations let been that to diagnosed approval potentially speak I So in me two can the OSPREY to who not indications called which CONDOR were There to these which the patients already are staging. The and we'll populations trials. a called studied. in speak studied be. And will have patients two what's bed. yet are were are initial us receive clear populations conclusively with prostate cancer prostate It's

So it's the the who are localized there's right prostate patients resistant. And officially complete recurred I is the biochemical of lesions population called then patient have the outside these would in, say, gland. And what's then bed. after gland, and other prostate removal there's

means in was been it already fact, that metsstasis the So the not, that, of curative patient, there had patients. for that

be patients tell can as it to refer or you size, the estimate resistance. these patients is an screening and from usually a that's we somewhat patients or entire the PyL initial what's receive called, a across is again, is annual because basis. a about prostate population or usually men patient of And have prevention purposes. staging typically, journey, points in BCR points both likely And population with been that biochemical are the time. on estimated a word mapping cancer. to a roughly what population staging the screening we XXX,XXX roughly the, scan. patient you're there's resistance I there is when cancer's done journey to BC Those in cases, imaging more or is for use And in time there's be will patients. are initial the who confusing In XX,XXX the So biochemical diagnosed

Unidentified Analyst

And PSA then I think guess, you the eventually testing? question that displace is, do pull

Mary Anne Heino

you it's gentleman there extensive can it the would is test purposes. of different used for track little other. the is not body. used one a a serologic Whereas is cancer oranges might is to to be serologic They call track of which in exclusive gentlemen And mutually a image treatments. blood of PSA is PSA bit be for because PyL action disease the the detect rising, testing, be testing. And significance apples exactly and can can what a for Well, which also a which disease, to or where be used testing be different would

exclusive. So not the mutually two are

Operator

question next with comes from Suisse. of Credit the line Wright Erin Our

Erin Wright

in growth kind How think throughout a lot about of volumes of we date. know kind generally variables the this in there's there, cadence year, and embedded that seen? you're And of just I in DEFINITY? guidance should curious finite seeing with what's terms the the to quarter out you've what but procedure of of speaking your

Mary Anne Heino

not do we offer DEFINITY. Well, product-specific guidance for

to that we physical would annual be for DEFINITY, of market the but speak number the me that who And XXXX we'll total those echocardiograms screening a or annual the done done we in our we cardiology folks of voluntary fairly in called hear decrease reach the seeking were either an not on and that. are basis was logic in a I XXXX, a publishing echocardiograms did level, You having are larger tendency invite track are offset the the checkups know used States. not subset types we would trend or in in those almost without would echocardiograms. But on to a of part or People are obviously as do they're performed were volumes I age And K, Many exams. United a initial were to and and of diagnostically I'd is certain explain. States I physical is a as the you read echocardiograms, the routine a United suboptimal seeking have basis year for in agent certain in say, number not prophylactic the in the of for image exams. saw -- echocardiograms, addition that course, an which enhancing what People the certainly of pandemic performed of to done setting echocardiograms easy ZMS. those say certain

cardiac done surgeries, or so gone work types with who the procedures has patient ups done along preoperative happening many to And what they any those procedures of an with them work for being where not procedures, a electric that with echocardiograms it. have good were history elective was -- along times of with as done the might elective have what with type would similar a was echocardiogram of kind not

And very immunity in healthcare are a in confidence hospital of DEFINITY of hospital honestly, the And of we the United so accessing comes much return outpatient of patients part of hope And of the patient's among confidence routine delivery a hope fear herd XXXX, there'll in exposure. States. confidence restoration kind to that of 'XX, normalcy, in my with is very to settings There fear a setting.Many healthcare the around of around nuclear are population this, hospital system. hospital part along a a see, accessing procedures, with our departments delivery of infection and that of in which very the done procedures comments the and with return with the to general issue in return or entering of healthcare. in what thinking much general vaccination comes quite in of patients build we in confidence the that be much our is

our that we does heard assumption healthcare the and me rollout so guidance our to are vaccine delivery. and to happen. is orderly will speaking assumptions you there spoke return that based comments, our that when And occur, And with predict of that, is there my as that Bob good normalcy on and guidance,

Bob Marshall

this guidance, And for their that question know keys models and adjust the need people sale. to me to the I let the Puerto keys, Rico you didn't But 'XX what are ask the one, add, precisely.

So to as my prepared be Anne the saying, the full the for expect broad covet the vaccine business But But be I that to calls growth. weak years. as robust from, is in drivers drivers as it that, as year foremost. PyL. for and of start going as in then I with second the been are distribution that commercialization that due XXXX. noted first QX Mary half mean the in key have be the would range would But QX company that comments given in provided, would would big it base well accelerating. well the we've initial what certainly it we

Mary Anne Heino

have year, case other traffic see, with or We do as our trends. actually call us. we for to very are noted And track, That of seeing. matched do geographic hospital country. we're trends And trends track would to that track, already hopeful rates, say, hospital I'm different it's, very track we that traffic. restoration signs And we've course, the product many last increased there the then around own sure we throughout as we on seeing, we're either

Erin Wright

And in the thoughts us now on And your and of business? your line Progenics top going would growth? to the contribute the curious PyL PyL, meaningfully dynamics. you time out contributions thoughts reimbursement line is did also to can were I you quarter? on the in remind when the break your view in there given rest what And approval be

Mary Anne Heino

what out coverage to I that's to the specifically because and clarity more speak process, reimbursement, think it something that speak lends From can the Bob to perspective, meaningful how gets not, gets, did broken it we a kind gets I'll how of reported. So it.

the, quarterly that pass-through. to based And you called by accepted applications With what's then product, diagnostic are applied those processed CMS on and pet a basis. or pass with a

first a then it's you're quarter. the amount processed as so by in quarter the of quarter and available your next listed then of the of within your And and that and coverage day becomes CNS be date by application first must

allow that, in one it It our of date. XX, the to steps. completed June is would by have to PDUFA application process be that May now hard-pressed application is some administrative have that you if requires there complete So date a

the to that. Medicare that you But can speaking your product The the, September prior intents you Jan labor-intensive. do all also is that there remember, we're a approval One, through commercial our purposes, and an X, on prior that availability effort for assuming purposes, goes mean proactively looking undertake that in through do is That does reasons. the, the not builds. only after coverage application that approval. CMS that then date, for would then we're also But intents not I means APT you cost can have launch at process with because and place by one and at referenced, the coverage pass-through is there in until payers the exists two Medicare, all channel So which can the to because for coverage XXXX. for to I'm one-off we as fairly broad process actual a that's for coverage, PNF is for And process pass-through. Medicare that commercial also

submit additional And your broad launch. our NDA You number. coverage you up to essential adding PMS limited for with is within, concurrent your Of United the NDA. of a goal you it's come have availability constant with with pants approval with NDA States at say, your as throughout six with I'd approval, after then offer application, out build months that application

Bob Marshall

about had your noted and Progenics growth quarter. rate X.X% math question contribution. organically, from that that then contribution $X.X And minus was the in is about X.X%, I million of

Erin Wright

know get just of question. how anything the last here. for target or you kind should margin metrics thinking or or tooting or EBITDA to of here But And be tax any line can operating rate us help the like to the year we now I there. about kind help below directionally one the us line you below

Bob Marshall

putting of in the that if the initiatives QX. a sort savings So is about terms again, in it you as talking Keeping me, half and cadence mind a cost will. the and of and in in we year of halves, revenue as excuse had from kind you think We're about of second think how in XXXX back we've, 'XX, The upfront through how some to place maps to going put two out tale keys you of that be acceleration. think XXXX. and

And some the into year. of those on initiatives of are savings carried the actually balance

get synergies so the of first you based then this of business course, year. half into Progenics back. get And of net the those added And

talked going also course, show up. So of in that in sales commercial as investments be access And for the then, office, balance both course, up liaison, and to or back terms set think, R&D the you as but of PyL, which involves is the readiness getting MSLs sales well analytics line. about which the as qualification market and of we and we and in teams talked PMF medical about also

in sort that described quarter You nicely earlier, at take the all quite of second But like, you're a things together of gets half sort million looking the robust a with, back growth of those leveraged and half year of kind of as year. of a I $XX the rates sort spend.

So sort of just up back that, too, step just one thing P&L you I a would bit. of little the

factors the we as a as in bringing have that And costs costs non custom our some moly models, pandemic look conclusion. with you lengthened States, through United as would first and flights forward have As having are think were so the bond those we the as because product beneficial of will margin less down logistics there to mix, particularly about well time, tech Genesis certain We One, in decay improving with bring in go we costs some costs have XXXX have around you that to at transfer go of as forth. as gross and gross you margins, we I year. also abating, foremost. impact were

labor will we would costs. overhead fact, be facility, hope produced have the being the approval of but that what we batches of to In ahead year and during would absorb

seen and at we that's coming probably see each would hope where we I from margins QX, what out but quarter gross increasing above accelerating and we more over would see recently. start we to that sort And of in. are So expect we improving of have helpful. on there for

Operator

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

Lee Jagoda

Larry. Lee actually It's Jagoda for

Progenics. make have it ton expect how much guess want disclose you Did I XXXX just revenue the I So of you numbers a relates Bob, sure right. PyL to to range? was there this guidance in I around from as thrown around,

Bob Marshall

We models well if just Rico, and see put contemplated that models people Puerto don't give seem together made guidance, publicly. be to have you who you product things and adjusting have that those will them level but by look available at fairly for

Lee Jagoda

as kind May for if occur. is you versus beyond know what people is, and going out the I'm out, not a maybe event knowing what product-level where what's there's given don't or guess guidance said, there give anything don't as can appreciate in say I spelled these the you you to guidance. in binary events just of I have helpful a guidepost I June, there's coming

Bob Marshall

the to on the but event, occur that the But how a the will of binary now, to as it's a Yes, event we that, look quarter-by-quarter year, second I right, think get through will we basis. right closer time quarter. same you're end evaluate at

at think sure thinking we'll informed well make on are our I that that So that juncture. people

Mary Anne Heino

this would And I we are assumptive are we our positively binary it think assumptive should comments, say, obvious that I that from be on on the point, it.

Lee Jagoda

about perfect sense. of DEFINITY, RT about makes that have the you the that the gave go the additional around gears follow-up, the place. approval new expect talk us opportunities of sort you you existing talk would to several next you color line of growth as switching the adding now RT opportunities product maybe bunch DEFINITY how product, see for to volumes Can plans much towards that truly then to No, we cannibalization could time And just Mary a how for this a much over in launch? Anne, versus and and And of then years?

Mary Anne Heino

So you our our I is product echocardiography to let's not predominantly with customer call cannibalization would in to customers. our make available the think US. not have of the it it, which current I is, the because would market think as set, strategy offering

to, as alluded we leading product. the and market I are, as know We

enhancing US echocardiography share We continue over to image hold market. the XX% in

product. from the DEFINITY There be or availability of to RT, there cover was guess now us choice, four. the goal there alone availability three have have now are our another refrigerated temperature products. so available And that I And their is should with formulation either customers currently approval the a to room temperature approved the market. to our room of there's

make that is they actively temperature room in we to are them. with the will formulation, to trying clear. for available note, said our actively And now of So not But any preference own cannibalize it have I that. will that, we our product to wasn't use case having customers,

can the it so shake since speeds, launching either will appropriately, and We activate any to recognize and and not only VNX. is other This time vial. what intelligence X, and this or VIALMIX different times again, the DEFINITY activation slightly differentiate which has be with it and proprietary vials activate we and also same between call to will vial the of recognize require type are a at products, unit, Lantheus RT, DEFINITY approval, we'll VIALMIX

our want gives to to they one so. also customers that of the do So to choose need only equipment product use and need flexibility piece they which

Operator

comes from SVB [Operator Newitter next the Richard question line with of Your Leerink. instructions]

Erin Fahey

Rich. is on for Erin This

if the quick a deal the could I from maybe laid question out? targets us. you in was synergy you Progenics just that wondering Just progressing talk how guys along and about you're have

Mary Anne Heino

and to I'll Well, deal, numbers. the can Bob the to speak get

year, NDA, on Bob for on targets. even the late. slightly PyL it deal but were some about from to were, at, actual let was are and very time, speak, the it's Progenics, looking deal, at retrospect, having the thrilled we month at with integration to that would hoped delay say, last than the is we that There Otherwise, process was we budget, it out. had our perspective, year filing are Whether target our We so later of We which looking were to we're been related to, the everything before we only to off we we on in closed integration transparent as employees Board. filing time, rationale approximately last From target how the we X proposed what I be you synergy say, or to. deal, before we're an I'll speak with the the working we've perspective, the the target. proposed assets we a it on closed Board

Bob Marshall

have about slightly, within were we outlined $XX was exited reminder, we the leverages only as that OpEx leverage not go we it. first percentage meets that and on ownership. a exceeds we rate as I'm with able as synergy ahead making just declining, run into presence expansion say we our we XXXX, that coming the deal as when had we but talked P&L was goal savings a those it but we that XX-month PyL to robust captured opportunity, in gross also terms of a to which have goes further that's margin of been And So XXXX, by a from of sure that which a opportunity million revenue think goal exceeded of of years. commercial sort that the and that happy the window target have

I July. noted said, more evident look last I on And So again, of that as our project it and as teams. become of it's been ability year, the as And the year like a this those opportunity to management delivered have affords fantastic through invest. the the savings diligence different embraced have well half the office us teams will and you as in into second

Mary Anne Heino

will prepare accomplished probably the not but preference, I to say isvery did as and hats submission and PyL our to in we and add, well just NDA as that virtually time off else certainly we little what XXXX. continue I'll everything to

Erin Fahey

then to And quickly. DEFINITY just switching the

like is in included how situations And not, TAM? you emergency that was maybe would this mentioned expand stroke, the expansion there think if into I had some that your opportunity?

Mary Anne Heino

are another study infection. DEFINITY. of for But the in approved being way indication, in in US revenue market under and myocardial in DEFINITY indication any are in neither And current the the use DEFINITY assumptions is those, a, for use there course, for for study the specific offering referencing to in insight me please clarify my Perhaps study I under So possibilities Brazil. I wasn't imaging example in But to where using. would that's a was way was for I agents. an referring Brazil That allow ongoing it. was was I clear. enhancing reference the be neither, studied currently is of included stroke. into

Operator

participating in There time. for is this and thank gentlemen conference. at This the program. concludes further question today's Ladies no you

day. may a disconnect wonderful and You have

Lantheus (LNTH) 27 Feb 212020 Q4 Earnings call transcript