OPK - Earnings call transcript Q4 2020

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Operator

Ladies and gentlemen, thank you for standing by and welcome to the OPKO Health Fourth Quarter 2020 Financial Results Conference Call. At this time, all participant lines are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised that today's conference is being recorded. [Operator Instructions] I would now like to hand the conference to your speaker today, Yvonne Briggs at LHA Investor Relations. ma'am. ahead, go Please

Yvonne Briggs

Company's of Company's could and by expected will such you This subject call risks materially be all financial the include, historical affect XXXX, December made be that limitation, report fourth OPKO described operator, you the including year Those will forward-looking to various with and any as reports. facts, other that XX, to Yvonne than for annual and LHA. Health's without statements results. quarter the and for Thank to for Form statements this results I'd SEC forward-looking risks uncertainties good subsequently XX-K in you, the like is remind SEC ended on call afternoon. during Briggs the discuss XXXX. management, in Thank considered filings, joining the of today's filed statements

information the Except live accurate call revise conference is or only forward-looking that or this by update required date as February of as no broadcast, reflect the this OPKO any of law, contains obligation Importantly, circumstances events to undertakes call. to the of XX, time-sensitive statements date after XXXX.

me CFO, the Frost, begin, Steven Officer, Jon questions. review then review we'll Dr. that, of discuss we OPKO's Dr. to the then Executive format Vice Phillip BioReference OPKO's Logal, will results, Rubin, let call and Cohen review; pipeline and fourth will open Before open the call. quarter a and provide after Adam Company's financial Chairman update Laboratories; business today's Executive Chief then and the will call; President, will

call the turn over to to like Dr. I’d Frost. Now,

Dr. Phillip Frost

call earnings full cash thank for fourth from and record we're and And reporting Today, you today. Good quarter for operations the joining XXXX. year the afternoon. revenues,

during state-of-the-art particularly accurate in resources, unprecedented testing testing laboratories scaling models significant as testing and BioReference adopted with innovative XXXX, a the Although in maintaining highly the to results. capacity, team of during of testing uncertain COVID-XX at quarter. rose had hard in invested times of working made up reflects and and touched an while at environment. timely PCR management We pace they fourth new COVID-XX volume services of human and turnaround capacity up OPKO Health proud COVID-XX Laboratories, our teams our We've ramp I'm rapid every to The by dedication retail record and expand partners, aspect was results to ability challenge fast-moving reconfigured and our talent technologies deliver quarterly BRL’s employees. our investments

substantially seen is capability across made pandemic, largely of will to approach are across new the believe to great testing likely testing We've testing the to our and and base the that into highly by availability to believe encouraged increasing on and decline, stage country. for And the pharmaceutical expanding and during the our our the historical continue to testing business by surge number COVID-XX administration's to business by fourth new levels solutions. stalled and demand as BioReference deliver the summer the and the have Despite recovered fewer fall reported. the towards industries return significant controlling COVID-XX of BRL’s base XXXX We country, vaccination capacity. in while pandemic us due would on cases Although compete COVID-XX on we We're seek the will it the end focus strides. complex cases of interest continues now and laboratory beyond. availability enhancing supplies, has rollout of the quarter beyond a national diversity business the

long-acting partner joint human announcement for filing for the accepted Application this was Pfizer highlight year that a Biologics License FDA the earlier with somatrogon, Our our growth the hormone.

Japan the in launch demand for restrictions impacted approvals planning submitted a by an Pfizer addition, continues RAYALDEE to be and our In regulatory for Europe. we're later a somatrogon, U.S., to soon is was Europe expecting marketing pandemic-related levels. in receive submission continues this and and Vifor Fresenius In make remains in to NDA pre-COVID year. partner Overseas, below commercial

last quarter, trial we Phase During year's COVID-XX in began with X patients. a fourth RAYALDEE

and results Our We decision and all D is inverse I indicate that become to want we we've business. have look follows who turn to what am COVID-XX between to to employees accomplish over when am trial forward call further what this in the numerous optimistic risk undertake Steve? trial XXXX. independent tirelessly XXXX I about available. to our you ongoing. worked now This over vitamin and in past Steve updating correlation severity. achieved an can studies on the thank proud they levels discuss of OPKO Rubin year. I I'll

Steven Rubin

resulted its of XXXX Thanks, Phil. afternoon, for thank BioReference demonstrated for year will only on And eventful national not detail. was This specialty Good you revenue the ability a more as discuss provider joining be a and pandemic. for in leading testing to PCR the testing everyone. record onset well. growth COVID-XX in position leading testing profitability, and Laboratories but genetic of us. critical the level, COVID-XX with which services Adam OPKO

Act FDA growth we children Drug the Prescription deficiency. year, weekly the once with with mentioned, review for announced also hormone Japan Welfare of for jointly Phil for for target The Pfizer and or action to BLA the Fee As Pfizer this Labor, Ministry NDA User FDA accepted earlier the somatrogon somatrogon. for of submitted treatment for year. an this in Health, that date is PDUFA by October decision

on As a announce that for marketing to with for expect we schedule submission shortly. approval, regulatory submission and Pfizer respect to remains Europe,

submit across has our regulatory and for program, is achievement submitted and Pfizer OPKO upon As in different to Under marketing Pfizer, a receive this continue will also to with agreement is milestones. eligible $XXX world. global up of countries to approvals many million pricing the certain

sharing and both profit Genotropin. tiered to regional, gross somatrogon upon launch, for Pfizer’s addition, In we're entitled

representing with RAYALDEE. to break quarter approximately for the starting follows. a turn by down of pharmaceutical approximately XX,XXX, to numbers Total reported RAYALDEE like QX decrease XXXX, as in for I'd RAYALDEE Now, IQVIA, our prescriptions QX with business, commercial compared impact sales were as as decline the compared with The force the patient COVID-XX XX% to with to doctors’ a decrease well continues QX as RAYALDEE visits on XX% physicians in and of to access XXXX. contend offices. XXXX

of decline. of X% become vaccinations were prescribers new Approximately RAYALDEE New rebound will total had X% new that increased the available of and the X,XXX nearly physicians infections in since XX,XXX COVID-XX by in by number anticipate was approximate We patient RAYALDEE to about patients versus sales starts however launched, QX. RAYALDEE as And physicians. prescribers QX or have QX. product more XXX prescribed

are in XXXX, in United pleased for pricing Switzerland, Fresenius, advanced. We Portugal, marketing Sweden, secured to Germany, namely negotiations for and well the anticipated are RAYALDEE the Commercial our the Norway, Vifor launch to RAYALDEE product, the adding seven announce and approved countries the Italy, Ireland, Netherlands. approval Spain, has Denmark that Kingdom, European previously that partner in have Europe, is

for to include macrophages, Should be enabling them raising we in The COVID-XX Emergency that D and within intend from with seek in production resolution serum the Our primary destroy and enroll randomized higher trial with levels four of maintain placebo-controlled These or a severity LL-XX subjects orally trial moderate developing X trial XXX XXX the in for which sites XX a Phil monitored positive, X as patients dosing have in time treatment symptoms. in mitigating one-to-one hospitalized XX-hydroxyvitamin study, risk with for XX- RAYALDEE ratio chronic per in treatment reports Spain antimicrobial total The randomized, the hydroxyvitamin efficacy approximately as kidney who this then reporting recent mentioned, the to immediate within daily secrete numerous studies Phase the enrolling trial. to X correlation illness. regimen of XX trial -- at the rationale D expected and across effective calcitriol from RAYALDEE release to and calcifediol double-blind, the COVID-XX a and two or underscores the order a of multiple of between serum outpatients being maintaining can SARS-CoV-X. indication. to disease many vitamin weeks for stage administered mill COVID-XX to D to been mill for for Authorization continue progressing, severity, thereby with quickly that more weeks. indicate Use are an Two is status is as and inverse range potent patients. per risk nanograms patients, data induce U.S. we designed COVID-XX either protein another endpoints to in including RAYALDEE FDA to There is The XXX independent is mild severe placebo, raise are to nanograms and is range

therapy from The report that XX% and XXXX first in admissions showed Castillo calcifediol ICU X%. by reduced

a nanograms interim line of raised or XX levels data we X.X% Phase to to X required The with to previously in at analysis XXX suppress with visit trial to the insufficiency of of XXX report by calcifediol exploring a occurred RAYALDEE elevated have effectively announced mill, both meaning second patients of of The by data placebo, this update our three for daily X RAYALDEE plasma stage completed on studies, and to range hormone Top safety X.X% high-strength of last these range subject patients is per same. vitamin a treatment CKD CKD parathyroid XX.X% vitamin serum new trial, of clinical admission D mill. with insufficiency. consistent a CKD. is regimen total for And patients hemodialysis. according hyperparathyroidism Final XXXX in X RAYALDEE X you D week, XX hyperparathyroidism in with patients that placebo. adult Earlier stage as the that that's dosing studies of now treatment the regimens on Nogues a those other XX-hydroxyvitamin versus for only treated deaths comparing XX-hydroxyvitamin receiving of X and calculations, of calcifediol the raise total of D XX% underway. nanograms patients XX in treated shows and with or last are the completed Phase or treatment adult patients required results, the in efficacy RAYALDEE least namely, with per to clinical serum X secondary and with fully calcifediol the X formulation stage level likely ICU common dose levels we secondary our was in micrograms D To

up. We follow-on our Xb back are Vifor partners also a Japan to currently designing in Phase study with

We on of Two diseases. our patients our advancing in in clinical IX, episodes Factor compound development. B our product in are long-acting here haemophilia early VII VIII with treatment programs focus and syndrome. advanced in recombinant prevention long-acting bleeding most have GLP-X The or that our long-acting rare and technologies short the bowel and Factor preclinical several for analog pipeline Factor is are platform with A for our or of inhibitors to compounds

Factor hemophilia patients. has in administration Phase Our completed VII X administration X/Xa compound intravenous study in Phase study subjects with a and with successfully subcutaneous healthy

treatment Our significantly GLP-X in have expected late function. long-acting undergone molecule intestinal over XXXX. trials offer with products typically syndrome for clinical loss believe technologies We enter resulted in to current complete market. bowel will bowel benefits massive in our the critical the syndrome of reduced short or short of is Patients surgery internal

over to me to Lab our the discuss Cohen call BioReference let turn Jon? business. Now, Jon

Dr. Jon Cohen

compared includes of our health We versus business last going of was testing. volume in QX women's review health this our and XXXX stable QX XXXX. start In testing X% with and year clinical to this QX core sample saw a of everybody. business testing oncology, in genetic to routine QX afternoon, -- to compared and urology, QX. of in QX comprising of I'm of Steve, was women's good my Thanks, which decrease especially Overall, core about of year X%. year, down a business, services our remarks

as still versus grew believe remain QX the reluctant many business physicians. that period, lower oncology patients the QX their QX. visit Our and will our to core business QX, XXXX, X% XX% are to versus We compared X% X% XKscore grew to for

have continues physician on In significant to a addition, visits. telemedicine office impact

We expect pace a moderate the trends this second at half during to improve of year.

of analysis The of to GeneDx in for QX that up volumes GeneDx have performance pleased to stable tests, ataxia, are ataxias. XXXX. was compared levels announced XXXX. the with QX of Friedreich common month, year volumes remained forms pre-COVID its QX for expansion including genetic versus QX this as we GeneDx of new several spinocerebellar hereditary XX.X% other and repeat launched Last spinal ataxia We

are access of majority of brand. comprehensive healthcare service highly for ordering in-home, a and and GeneDx under provider. testing are patient updates the strategy involved After center adult-onset professional’s genes on or specimen. securely visit ataxias. provides of health advance Once services. to time link for patient could or we tests the covers for created by the specimen to they BioReference tracking an patient their prepare learning first expansion on-demand at alternative and a were an to that in-person patients. traditional for healthcare to Scarlet healthcare diagnostic home office. and real-time to can believe the digital in their That be BioReference’s a specimens location With where relevant utilize platform available innovative a information announce as the We affordable visit, a excited the how has to receives sent our then elect qualified such is flexibility delivers choosing schedule fully the collection, digital location results digital the collect to and that and many convenient testing, these future an patient's to focused offering formally to visiting Also, with initiatives patients date, additions, healthcare and for convenience for vast Scarlet Patients to a with online service is receive the Scarlet and home collected, and the integrated providing professional the pediatric-onset provider, January, arrival. Scarlet and

requisitions the the to to year, for dramatically XXXX. the XX patients day COVID more day. Now, In In last in up staff need million from XX we our our increased me X,XXX year scaled We is accommodate from from to clinical XXX. per testing. turn months, let We which serve patients gone requisitions a have headcount my employee last XX,XXX we to to And a we performing Company the year, X,XXX. attention testing. XX XXX now increased a from XXX,XXX million

about date, we more than for million quarter. fourth million X.X XX.X performed In testing As million third molecular performed the nation. COVID-XX COVID-XX is X.X in XX% the the to COVID, tests PCR have tests which up we performed in the tests, from quarter,

over hours do XX,XXX a day testing day, governments, with the between systems, to turnaround remains XXX,XXX a general to in in most We employers, the will XX,XXX and tests detecting play tests of disease important timely devices with that entertainment long-term XX BioReference facilities, solutions venues, to an sports schools, testing are and point-of-care committed is important. teams, hospitality, of averaging believe an and transportation, with country. Aid result with the Rite the health than with cases. providing public per locations current than around through role needs now increasingly where average more PCR time COVID-XX capacity in physicians, relationships We CVS less situations X,XXX rapid innovative the our

many different validated solutions for to platforms manufacturers customized have partnered We industries. several different multiple with and point-of-care provide have

COVID-XX point-of-care rapid have fashion. point-of-care National have several results To-date, QX. National officials, Last month, the seasons the and we league for agreements the Basketball well testing players XXXX and as for announced Hockey the report different we tests in to XXX% grew And timely clients. QX and volume for performed to as and a deliver our We staff developed team for for XXX,XXX XXXX League. test Association, proprietary devices for from and software

with to We coaches X.X the performed organization XX a dominate tests XX staff, in the the routes teams logistic XXX XX COVID-XX partnership a We our NFL with rapidly and X,XXX NHL across with with for XX that support teams sports players U.S. day continue with to operation Xth. in cities, to part also growing the and proud for XX I'm want NFL. to Testing Super one the than cities resulted to we and NBA our cities, ran multiple country. on strategies an teams less baseball, Major of these culminated so rate of Bowl the call an commitment just the mitigation infection safety with vertical in around in the major every the provide services contracts the months, XX million compulsive professional the out seven announce logistics and I venues could and games X%. with that that be in February NFL’s soccer played major was agreement today now BioReference teams five for performs this COVID-XX leagues, point, of testing have League hockey. Baseball XX, basketball, testing for sports and COVID-XX mainly U.S. XX,XXX to At all all country. that football,

supporting In Aspen addition Winter in U.S. X the the BioReference Games is successfully and supported

League Soccer’s teams, G in the women's and NBA Orlando. national men's and

testing fan This within high-profile all the BioReference’s game. games. in the organization of partnered national for quick to PCR government allow fans obtain attend COVID-XX has each highlighted and required to COVID-XX the private is and teams, a U.S. numerous the to with was leading to playoff BioReference of kind are and two Bills performing X,XXX laboratory the its first several Buffalo their led position fans We and XX these response recently program results for contracts as pandemic our from to of hours testing. of

one relationship country of the in school providers our New for students largest in City. testing to York the test are We preferred with students public of

tests students We a XXX,XXX that program tested schools now with weekly. almost almost have X,XXX

it point-of-care large-scale the COVID custom Our tests, provider solutions over like screening our to Adam. both and I'd leading utilizing, And now, has turn as in positioned programs the country. CFO, lab-based PCR us of to

Adam Logal

Jon tremendous financial fourth The effort and quarter the Jon. results reflect you, Thank that highlighted. Steve

of operating in million, the profit BioReference, was Total of more an cover also performances over will I contributions million. business, of the shortly, despite $XXX teams positive challenges, than commercial more along have led all international our XXX% team solid across revenue delivered RAYALDEE our increase resulting but detail all in quarter our As operating portions by commercial $XXX our of companies. operating with most profit XXXX’s for by

services reflecting diagnostics operating reported an impairment $XX.X to XXXX our the an improvement to $XXX the quarter strategy, continued compared COVID-XX testing in of volumes our related and volumes our Overall Overall, $XXX XXX% administrative quarterly of revenue historical in business, historical genetic XXXX charge income XXXX an costs from The improvements. $XXX Claros sequential decreased million research of testing, The operating compared for compared percentage overall to the improved due loss to million and base development increased net increased of clinical resulting Combining execution of costs was a the as however, revenue of the million, below remained testing. included XX% overall over leverage development routine volumes business, our Jon testing increased levels, $XX noncash while month, overall our $XXX.X down segment $XX.X genetic of period. reported and segment testing to XX%, overall Our business of by in compared general $XXX.X period. testing well fourth million million mentioned. point-of-care to increase diagnostics levels. selling, expense period. by program. million, to driven including testing as COVID The operating as revenue to million, a Total million of in of routine from our and for each expenses being XXXX compared improvements increase revenues flat over as XXXX,

which for the including XXXX for revenues segment. compared We from million, slightly period. of $XX.X of RAYALDEE. $XX.X fourth quarter representatives of from fourth RAYALDEE, of XXXX restrict been in for reported revenue $XX.X sales office million from the physician the by to product $XX million of and of making and quarter overall to Revenue sales quarter compared to rate the $XX.X $XX.X patient which product visits. pharmaceuticals million fourth orders has the The decreased to million stay-at-home negatively our calls growth Moving from XXXX, restrictions, impacted reduced revenue million office XXXX, of RAYALDEE included

to intellectual the Phase sequential the price improvement realization. year completion gross in XXXX million from When looking compared However, a reported the property, net of somatrogon we revenue to period million of of $X.X the $XX.X X transfer a at saw our trial. reflecting for ago, clinical we revenue

we for payment. the for reminder, had XXXX from period now for Pfizer million. programs. million, $XXX.X that $XX.X compared an fourth from million period. operating our a operations on development development program. upfront a of spending million Overall The of of segment $XX have On impairment significant amortizing improvement XXXX related in As operating basis, charge amortized $XX.X upfront reduced XXXX of of XXXX, XXXX, the of been the was to fourth fourth payment Loss was fully $X period profit included $XX.X had our acquired expense million pharmaceuticals consolidated somatrogon compared two our over XXXX the a to of and research million quarter from over our to million, million loss $XX.X and quarter quarter of XXXX’s reflecting the development an $XXX development

for Our per net income per diluted period. for was of quarter $XXX.X $X.XX the to $XX.X compared loss share, or share million million, XXXX XXXX $X.XX a fourth or of the net

fourth for XXXX, a December of operations, of $XX million. we generated Finally, from cash balance in XXst $XX.X million cash the of resulting at quarter

us sheet resources $XXX and heading cash into credit. We have of balance of strong The adequate of credit our provide combination million and capital a XXXX. on hand under with approximately our lines lines available

As we generate continue operating profits opportunity we a and XXXX, of see quarter the look forward flows. to significant into to cash first

forward demand providing for greater the the look the we see remainder limiting evolves. as guidance quarter of of XXXX, for we Given demand to first uncertainty and testing the insights are XXXX, testing to our into forward-looking how

during the anticipate into the we've We the and following antibody performing quarter. forecast. our X.X quarter first million assumptions PCR XXXX, million between X.X For first of point-of-care and tests COVID-XX built

mentioned, digits sales levels, first until we behind our expect to levels remain and for high current our With for to testing XXXX quarter is assume that, clinical guidance. should genetic beyond we at of As levels, activities force which n RAYALDEE could of the these overall, business to behind increase, sales of excess at remain expect RAYALDEE the XXXX base fully return be to demand time to we services levels. routine anticipate XXXX growth. to able our the testing will to overall in promotional for single both of first million revenue capacity quarter to and return We XXXX our which well are mid have Jon expand We the $XX million, from and revenue revenue of $XXX products to and of million million, million $XXX million, revenue to $X $X $XXX other million million. between $XXX from including $XX revenue

an Thank from will as and that, you. instructions] I Maury Our for open We expect costs points to of $XX $XXX to includes million and Operating $XX million, amortization of With expense million the call $XX come up first of well operating of as Jefferies. $XX between question at Raycroft from [Operator non-cash assumptions. revenue expense, expenses development of to $XX research million. $XXX Operator? depreciation million profit line expense questions. to the the and be million an between million profit in expectation approximately resulting will various and

You may begin.

Maury Raycroft

Hi, on And the all Congrats everyone. the today. for taking thanks questions. updates progress my and

think and if question into reimbursement how forward? provide PCR you just and checking pressure with I saturation to guess, about going testing should perspective the First increased testing is can pricing for competition. see COVID-XX reimbursement we

Dr. Phillip Frost

Jon?

Dr. Jon Cohen

into you point-of-care? to I want don’t to, know, me me Adam, do want go or you

Adam Logal

Yes.

So, we mid-XXs, kind for to level, mid continue PCR. overall reimbursement of see

enacted Medicare. first the our the despite of going have stable quarter, think, is been that continue changes I view that some be under to during to is

reimbursement remain pricing at we're those levels. I and should overall our -- think,

Maury Raycroft

Got it.

about Okay. that? are then, and how testing time. over be thinking And How COVID-XX business guys personnel back COVID-XX think demand base wondering conversion also retreats of will new you to you as the about what costs testing

Dr. Jon Cohen

Yes.

confuse I long-term point-of-care a -- to with -- rapid the don't PCR think, what's I happening the the side. testing on or want

be PCR still to amount testing, lab-based is interest continue there different relationships So, will eventually, being test a of between desire their relative honestly. or point-of-care that when fairly multiple to don't so industries rapid whether I know to contractual or which established large quite and it's

demand industries. there's plan any going -- workforce I point-of-care don't So, yet for relative the on to of the COVID that seeing multiple to downsize no on of side the we're huge because rapid for what's

Maury Raycroft

And then, last question is RAYALDEE. on

bit why measures a stage CKD about far that as as reporting bit data number study that X as you're So, plan planning the little and about you you patients a talked well? just data. talk you on some going the through you're of little Can more on of the reporting the and

Charlie Bishop

Bishop. we Maury. just is total of study study, Hey, involves This subjects. Phase Charlie a is it's X. that an It the early Yes, completed Phase X XX

a So, the showed in that that the there's to dose three treat basically we'll we Data we we hyperparathyroidism. to even that dialysis chose. well successfully required RAYALDEE change safety maximum dose be absolutely used on thought would of design And look at to One be highest order to X randomization secondary no in the the parameters all, at was the patients. placebo. things. And study reporting at active is X tolerated by

And that was medical be the Secondly, see patients in the kidneys, and is the activated functional extensively study literature in don't RAYALDEE who our could required selection this if goal have of patients it study, activation for the I to patient go fact with RAYALDEE in literature of in follow-on It's of And RAYALDEE part kidneys. your found Xb not. very lastly, And lower see to and is functional do that was kidney. the respond we some is lower us can't. into Phase study that this we if the patients medical to could the without criteria activated question. development drug this why why out the to we patients, is study in will hope other the PTH others could many to is up now that study. do that figure we PTH. And designed, what readily And, have course, answers we contrary nicely; found of process. teaches

Maury Raycroft

could RAYALDEE on studies? maybe reported results see Yes. or can is more data And just the COVID-XX time, helpful. you the same when both That's provide granularity any very these might be follow-up if from time, last at a we

Charlie Bishop

as that But how can't Well, because stay were great high, really expect is ball go. we my pandemic wish good. long tell I as will be I the to enrollment infection rates you crystal going

keep designed agent, in that or all a shorten is are should take COVID-XX to can time study, suitable in the ongoing for not study not they few patients study we’ve symptoms. You if have like But It of asymptomatic, symptoms most the very resolution outpatients. see RAYALDEE, to to mind an comers. and

even select not the We we the that have have though the patients see effect who significant can drug. so symptoms, to hospitalized, of they're

infected a total that's this subset So, population with SARS-CoV-X. requires of the

Maury Raycroft

Got it. very helpful. That's

questions. my taking for you Thank Okay.

Operator

Guggenheim And our Geiman come Partners. next question will of from from Devin line

begin. You may

Devin Geiman

for throughout taking you Could is other? maybe for still to volumes, in happening? you aren't do as rollout to vaccine of then, is I healthy one Devin these year the and there -- the be guidance to the some progression Flanders. pressure there from Thanks you. this I questions margin on XQ. contextualize PAMA could quarter. Hi. commercial us, a potentially tangential lower parts margins moving to question for under a presumably more headwind kind improving gave level I be cuts of from you and Do and on just offset And I just the for, that expect expect do you testing know Thank beneficial of a lot perhaps maybe reimbursement had you Thanks different congrats Dana again guess, volumes with, on This Medicare that, guess, this margin what tailwind payer expect COVID of by are the know XXXX? levers the base I business, continues. offset I a than XXXX. guess, for or

Steven Rubin

Devin. Thanks,

them Jon, address to weigh try I'll in as well. and please So,

third pretty margin and I are So, the what evolution, you saw conservative. the think, in quarter fourth

those also think I as healthy. pretty PCR will Jon and highlighted to I us healthy. volumes stay the point-of-care, COVID will remain stay think continue into pretty, The margins as for testing move,

business think, about I is as the to structure levels, historical XX% XX% is base at of cost there. the

closely really, the items. COVID is changes, going our testing So, come very drive costs through to what's really variable that tied on revenue line both margin to

baked XXXX. into pretty the I think quarter. the in and to that Medicare relates -- the meaningful changes XXXX gave numbers into fully and expect we is PAMA to As it reimbursement any overall the first changes is much I don't Obviously, delay the of for don't PAMA,

Dr. Jon Cohen

Yes.

more was won I there's discussion you I ACLA. follow way until that this, I an think priced right. the on was at there's appeal right now, the probably don't And mean, that earliest. PAMA XXXX by PAMA of much see that's --

lot of going where there the head muddiness a around PAMA and future is to PAMA of So, is right now.

Devin Geiman

you very much. Thank Great.

Operator

next our from of And question Sandler. comes Edward from Tenthoff Piper line

begin. may You

Edward Tenthoff

I you. everyone. of to evening I good in done. echo important that Did all I make and this you your say quick question. just of hard Adam. When for the had want was being work I write-down. recognized? of right, terms Claros And that's our the testing Great. thank heard $XX.X sure all want to one Thank million that

Adam Logal

December. year, last was last That

Edward Tenthoff

then, tell much. very then, being work readiness? both on anticipate would looking is side, can at Pfizer Thank what somatrogon, there over that commercial respect little done, about panel, you at the and to prep regulatory you And a also us be bit you with a do

Dr. Jon Cohen

The responding work on are Miami. various Ed. basis panel, is don't There in down real-time expect is, including inquiries. inspections on, a going Pfizer we're to some responding here We and

through at point go course we this ordinary pretty as process. the that's So,

Edward Tenthoff

then, And about side? what on commercial the

Dr. Jon Cohen

responsibility has activities. Pfizer primary So, the got the for commercial

think direct you'd to I the question have So them. to

Operator

the question and of next And from comes our from Laidlaw Company. Yale Jen line

may You begin.

Yale Jen

guidance million serological quarter. guys question vaccine? the PCR of Do first that million thoughts for in I trends test the have have XXXX, getting you The tests especially in in is of any first people with to terms your X.X for terms the more X.X

Dr. Phillip Frost

to do Jon, want you manage…?

Dr. Jon Cohen

about the serology the Is test that antibodies? talking you question? Are for

Yale Jen

Yes.

Dr. Jon Cohen

Yes.

know, So, antibody hundreds of testing, very several if still thousands it's I capacity a be. of need to do have large we -- don’t

was antibody least point, are at the both the quantitative from have moving on, first are which assay, qualitative out. running this platforms We away testing at different which the two one

I anybody whether don't you now amount question much the document So, right how think could effectiveness to on predict get testing that now. get which of occur. But, the of of the will going There's have will of documenting discussion -- disease. to vaccine, which post to depend who's a a enormous vaccine vaccine or testing either serology you either right bit about antibody

I I or a of antibodies disease enough a that's, the think than you can guess. that's be you've Some but had whether maybe it will vaccine, a probably believe meaning other And industries, it's to coming travel internationally. have up, have validate role either probably travel more related probably to biggest

Yale Jen

on question COVID-XX One studies. more RAYALDEE the

a mentioned portion that the you COVID give You more selective relevant. patient, patient us there's is of what RAYALDEE? only be of Could sense would some patients treated hospitalized suitable by for

Dr. Jon Cohen

in that require the using quickly patients that's a get score to infections, even that's fairly ongoing a is hopefully those treatment. in study primary we disease and a What have level for in course we're to does into been can active versus the we time tool of it on what viral certain above for enables the to validated few long resolve order endpoint patients patients, that that tool placebo who in reported a the be study. differentiate enough, and And efficacy is, long outcome quite patient

the see So, to than with days wanted ranging from we the see. resolution able what of a we're to more X I'm pleased that into We study. to exactly way enroll time XX, very patients to in that's spread symptoms

So, patients monitor their day and improve every tool this fill how time. can out symptoms over we

don't can this It's to want but that possible we accelerate patients, that. in hope higher yet resolution Now, symptoms somewhere the plans would we're would do the to from seeing enough what at treat literature patients what develop I it's a from time try around they have maybe also of on see in expectation, symptoms. answered of and to to have XX%, that I based range little percentage we your the we to hospitalized severe our treat screening that drug question. the

Yale Jen

helpful. great very is again, on That And the quarter. congrats Yes.

Operator

from will line from you. Thank come Instructions] of HCW. Our Yi [Operator Chen question next

You may begin.

Yi Chen

My guidance new taking for to test, World to is, my cases Organization PCR lead recently could Health you has COVID-XX their Thank a lower in reduce the which released number the that Hi. question. count of cycle detected. should they question stating laboratories,

So, what's your on current that what's practice? and opinion your

Dr. Phillip Frost

Yes.

different platforms at least four manufacturers. run, now, we So,

will particular well, the relative results. out should to EUAs manufacturers them values, a to I they of what -- report -- platform approval shouldn't One out position requested in report how not their getting there's values. that CT really cycle be relative don't in or two, to or we, time we're determine their if

values we to and the a be be decision patient relative that will So, make have platforms. how CT if request a the vendor it that out decision. physician, reported, client client. changes to that values platform report on we That that reported CT to get reports would But don't in we

Yi Chen

you. Thank Okay.

Operator

line will from Research. And next Petusky from of Thank Mike our question you. Barrington come

You begin. may

Mike Petusky

Thank Good Thank evening, guys. you. you.

guidance… So, Adam, QX not That your caught I quite may it. guidance the essentially for was have is QX wasn't But, it on just, below 'XX. RAYALDEE simply

Adam Logal

That's right, Mike.

So, included but in didn't exactly. out total I break it the number,

Mike Petusky

And Great. tests term an then X such people -- know it much from and now? of or we you then, hold a three still of serology near about revenue a part X, Thanks. is I meaningful longer this years I materiality for anywhere still now, I reduced, right. this be But, and suspect to but think that ever-changing, sort All sort not regularity BRL question, it's as mean, X, Okay. of take that I a vaccinations is as PCR from time, learn COVID-XX is tests, over years guess, more. do

Dr. Jon Cohen

Yes.

Nobody any goes away. one that's over morph this I everybody evolve next So, We idea the has how right? two think, question, multi-million -- or years. that all the dollar to this will hopes

of are existing by or of some right treated least does other testing? We depending all not and/or mostly, course, that now, as The being the variant that the variants having current emerge be, have that, data question will at some type yet. vaccinations. some Now, mean said seen other on treatment -- the changing by

the So, it fall? everybody three has I right is don't far now, be it just you It's just risk. I vaccination, answer that needs anybody, is going vaccine is so give it's can predict one to haven't now. honestly to every is now, or where much seen that. the There the So, it The don't time, I think flu, with right out. anybody like the too from COVID think vaccine years question same

Mike Petusky

it. appreciate Fair guys. Thanks enough. I

Operator

for queue. Dr. showing to Thank not remarks. Frost you. further questions I'd any over to the turn I'm closing the back any call in like

Dr. Phillip Frost

look you all Thank to again quarter results. forward to good questions. with first your participation well, meet and night. you for and Stay Good report the we

OPKO Health (OPK) 19 Feb 212020 Q4 Earnings call transcript