OPK - Earnings call transcript Q3 2021

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Operator

Good day, ladies and gentlemen. And welcome to the OPKO Health Inc.

Third Quarter 2021 Financial Results Conference Call. [Operator Instructions] I would now like to turn the conference over to your host today, Yvonne Briggs. Please go ahead.

Yvonne Briggs

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

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

format Chairman open call. and will we review today’s Executive Vice business Dr. begin, provide will Officer, for Executive Dr. up President, a Frost, the update Phillip the Cohen questions. Rubin, and quarter And Chief OPKO’s then me let results, Steve first Before call; the CFO, we’ll After will Logal, for Jon pipeline review company’s Laboratories. will discuss then financial and the that, review. call Adam open BioReference OPKO’s and

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

Phillip Frost

business. you the call joining for today. with start thank with Good pharmaceutical our our start and I’ll pharmaceutical afternoon business. I’ll

once for to milestone NGENLA become deficiency. deficiency. effort growth for release hormone Canada’s first with pediatric with pleased provide our last important a therapy indicating approve in is Canada press Pfizer children the Somatrogon an This the hormone We’re hour, that country weekly to within long-acting, has growth

the the Somatrogon in half continue first dates regulatory U.S., of during to expected global with advance Our and XXXX. Japanese European action territories applications other for

time efficient by execute provide partner have And at our we an way funded same valuable We the pipeline others. eventual abroad. distribution, and as particularly continue to consider for to for that their technologies strategic projects

describing – our on raising in for detail COVID-XX announced enrollment COVID-XX, in more D completion studies patients with announced Vitamin China, the we During with rare and is LeaderMed In X COVID-XX announced deal opportunity Therapeutics with the inverse call, XXD quarter, recently trial our Factor in severity. serum disease of new a for we and levels, transaction numerous believe in of cases kidney another and and we RAYALDEE products territories. for will This with of China for to our CAMPX oxyntomodulin last technology in novel This in of an especially safely discussed one this partner our significant and outpatients. with chronic report blood genetic other extend long-acting option an August, been disorders. for we independent Phase our Group past the have geographic There local Steve Nicoya Therapeutics level provides of between correlation best knowledge partnership risk in obesity. VIIa-CTP a market. reach that a moment. has or provide experience RAYALDEE We Asian development and infection RAYALDEE AntagoNAT

We expect for end to this announce top of the study by year. line the results

to return core reference XXXX levels, to most laboratory’s your continues accounts physician to pre-pandemic business with For clinical close volumes.

be The prenatal Last Our Ariosa the health, quarter, women’s our compliments Roche. laboratory surveillance diagnostics of BRL’s prenatal the large industry, present GENPass schools, to and with testing cruise non-invasive, growth business blood from to U.S. announced of COVID in of We’ve partners, drawing urology, specialty a screening. is oncology, acquisition business This areas offering focus centralized the four growing testing BRL continues. partnerships. and strategic service for and available Scarlet employers home, of U.S. is new added many clients Scarlet our now Health’s continue screening and population. sports XX% vibrant.

Our testing of good core the public, business. the portion a our of is variant which grow general has COVID the Retail care Delta decreasing. testing with testing and of of spread September now continues and slight become to in August

Delta turn the now has surge Steve? call will Rubin, business, begun our commentary Steve to wane. on over further the As pharmaceutical I’ll who to provide

Steve Rubin

afternoon, you, thank Thank Phil. us good And you everyone, for joining and today.

We volumes. third our its continues strategy. financial results business pre-pandemic are our business pleased with to as returns advance licensing quarter pharmaceutical core BRL’s to

NGENLA pediatric of we once weekly hormone course, about growth who from failure growth to patients NGENLA the or for with growth are care that providers Of injections. as for the of from option and for deficiency. their an GHD. with long-term endogenous long-acting patients, ones injections or deficiency provides reduces common approval known is Health inadequate to particularly pediatric a treatment, secretion growth have due treatment hormone excited Canada somatrogon human frequency hormone children treatment weekly loved the growth NGENLA the daily hormone, once pediatric otherwise

to $XX advance by action development million this of triggered this in $XX the U.S., milestones to U.S. certain from a Japanese and with for in million. agreement approval the other and ranging and with into treatment regulatory commercialization to major markets. determinations applications of the expected program to in half regulatory Under Our These first of million We are of receive regulatory during dates with relatively agreement, global worldwide Recall near more upon in OPKO future. entered other XXXX. somatrogon territories European eligible we up milestones somatrogon news positive pricing is continue the the hope for $XXX share to that GHD. achievement

regional within were both U.S., double-digit daily GHD on and sales Pfizer’s to within region. In a a profit Europe of sharing upon Japan entitled regions commencement drug sales sharing royalties of Genotropin. such of Pending of addition, term are the somatrogon we launching the profit entitled the to on somatrogon tiered gross region, primary tier and

numbers representing to for X Total The in onboarding new levels. the by for approximately patients. adults XX,XXX in chronic the follows. approximately hyperparathyroidism reported pandemic kidney continue for of X from XX,XXX in Vitamin XXXX challenges breakdown to treatment our by for low and IQVIA a RAYALDEE as impacted were quarter QX RAYALDEE, XXXX. be related QX Moving decrease D stage disease secondary prescriptions sales and in RAYALDEE as

Although, we has sales trend believe and has bottomed out to started in downward the reverse.

in treatment nearly August, decreased was patients last symptomatic to QX. ml exited RAYALDEE endpoints nearly and The New a RAYALDEE XX,XXX More by Since QX. we of self-reported to subjects symptoms RAYALDEE Phase COVID-XX RAYALDEE in versus and resolution subject to than the a as in X nanograms starts total REsCue of prescribers prescribers in patients used were ratio four COVID-XX each follow-up. enrollment this product include validated study completion raising QX treat Final enrollment X.X% a by with the month. Phil as per number approximately announced in XXX two-week questionnaire. in were XX-hydroxyvitamin a earlier outpatients. of mentioned had new weeks late The total trial our total launched time positions. And X,XXX to placebo the efficacy by of trial the to patients XXX primary of prescribed day positions X% of have or and XX XXX with randomized D in maintaining serum COVID-XX subjects by one-to-one

and and manufacture Top this Group expected medical urgent life this by for Factor the will oxyntomodulin duration oxygen XX% for commercialize and of being LeaderMed severity, endpoints below data an mechanical long-acting Factor line VIIa-CTP emergency and mortality is treatment care $XX novel and by analog efforts in as or LeaderMed room in In being developed million. evidenced saturation and from OPKXXXXX oxyntomodulin announced interest include quality the investment territories. joint development finally, of of and made other need ownership duration operations, Secondary with ventilation a obesity an of illness measures. controlled of hemophilia. for and requirement the Greater hospitalization venture treat placebo of biochemical develop, to September, trial China Asian holds visits, incidents and coagulation XX% double we joint be venture. rate diabetes, commercialization line to VIIa-CTP for randomized end are is OPKO year. venture’s a and funding joint initial of responsible the and a eight developed factor

geographies. VIIa-CTP other oxyntomodulin full Factor We all and will rights retain to in

Cohen to Now discuss let call over me BioReference Jon? to Laboratories. Jon turn the

Jon Cohen

used Test prenatal in screening million has blood from laboratory continues of third we subside. U.S. period. Women’s BioReference’s called down been announced acquisition more A cases and weeks XXXX. patients. is Laboratories quarter and was last in Ariosa’s QX X% the BioReference tests testing compared clinical at than everybody. testing slightly the XX Thanks, Harmony is compared afternoon, volume and test COVID-XX as pre-pandemic are as performed the widely XX% core clinical of is the to It year-to-date risk genetic the most prenatal health core our end pregnancy business early testing rebound year centralized and levels as our screening good to non-invasive up one August, to lab that is syndrome into X.X prior assess specialty tests year. study designed Ariosa of is other of Prenatal the versus up majority accounts this of Roche. to Steve, a more of abnormalities. normalized volume In so the prenatal and to business even levels to and close quarter

the which GenPath. fetus are offering XX indicative risk that conditions. could lead the assesses at NIPS XX, to current acquisition test in of our NIPS an Ariosa complements the Specifically, of chromosome XX, genetic severe of The extra trisomy and

pregnancies. as changed recent have NIPS addition, for most In that guidelines of to ACA a result include

NIPS NIPS With We NIPS expanded volume. driving expanded a focus to will client in potential triple broader pregnant the continue focus our base, and NIPS driving on significant current coverage sales women, to agencies all focus significant base. state the for sales and client for Medicaid on with see for we in

in in prior in Our launched outperform hematology hereditary in best solid new multiple offering continue over growth business our cancer offering. us We help year hematology testing. tumor, up XX% and to oncology with and QX to a to class be myeloma continues NGS, is

to initiative, FQHCs, strong reference our our business systems growing performance care medical from hospital medical including large group partnership in groups with capturing strategic significant as and more account business, well health Our organizations continues partners. as grow physician

In center offer home Scarlet numerous offers a who offering patient benefits other addition with We testing. several with plans. Scarlet need homebound conditions begin digital visit advancements national routine members, Healthcare patients Scarlet chronic Health. to service August, solutions time pleased health busy for and United we our services regional were have to who to do not continue draw to in patients, make to

Health Scarlet demand for Health for to Scarlet Scarlet see pre-season and U.S. now with collegiate for forces testing In multitude the We is biomarker in joined sports commercial specialist population. physicals to across a athlete the to professional provide season and we performance athletes. continue verticals. September, of Orreco available significant XX% of company and

Now, like address I services. our testing would to COVID

and During XX the million performed significant third saw quarter, have begun surge volumes in have retail than July a our the molecular as September. tests. Since we to PCR offering million COVID-XX we peak as COVID-XX come began, We August of perform retail access delta in at tests. in our the Retail again in increases delta volume sites. result X.X pandemic more down

normal continued flu underway, a our nation testing anticipate the amount to combination or testing BRL they our physician or with want have whether to COVID With patients COVID in a of we significant individually the surveillance continues as those flu ordering will returns season testing, perform as tests clients, either offering. to now life. determine from flu clinical

programs We private the NBA believe over continue for continue school these the executed public for customers testing sports systems, XXX another large employers will quarter. robust to their programs, testing for and leagues, to our and NHL serve cruises are agreements many entertainment their our cruises throughout and non-vaccinated travel We events, large that of screening a In for the started have virgin XXXX. new COVID-XX industry. QX, for the performed We employers season. this employees. and testing Many we NFL, demand

markets. XXX are USA XX in sports over servicing teams major We over currently

Hall golf, ATP qualifiers, race we USA sports NFL events, addition, League, of large hockey events, the USGA of Fame, the car In Formula Basketball USA Premier AHL Marathon, Olympics, soccer Lacrosse World stadium race, basketball Hall testing. other including employee kids soccer Fame for the MLS tennis teams, Cup tested and law Chicago camps, E

the the performed FC we Tony for addition, Awards. In and testing

have the role with care important of continued to offering, the U.S. onsite free Health the the play schools XXX,XXX prior COVID-XX XXXX/XXXX in the COVID Services, testing to Department state of opportunity at point to year. for COVID-XX in program academic we conjunction across Our point XXX,XXX star of school public Human COVID as shifts Year-to-date, care to we very of our RiteAid testing capabilities New man a and of almost offer to QX. screening. conducted the and announced In students back tests, York

able continue active be to pleased initiative. support to are to with programs We State’s New this York surveillance

we to our than we addition, sequencing making more XX% In the school year genetic our Genetic for demand the announced set leading period, its program that have GeneDx largest testing industry of volume at XXX,XXX completed In exome around exome in testing country. testing by continue clinical driven prior strong more by patients testing versus September, company’s offerings. world. for than data the kind the the GeneDx increased

to disease also two supporting genetic our testing at Adam. The now annually disease played suspected added more to will exome These to Axonal and to diagnosis having access biopharma accelerating included With the or the relationships. Giant rare thousands Krystal it panel partnership important expanding patients, skin with of while with for our GeneDx test increase clinical turn and diseases. to than test for I over a partnerships volume XX% new hundreds of partnership Neuropathy also of Gene neuropathy CFO, Biotech risk understanding role Therapies a testing for diseases. rare the and hereditary has rare in testing team of an individuals of Taysha sponsor

Adam Logal

Jon. you, Thank

income net XXXX $XX.X XX% million included of to XXXX reported quarter, diluted $XX.X the in Net our we parts produce on the operating million of operating income all increased third consolidated our $X.XX third for or the XXXX share of quarter the operating to financial income period. compared For a million the income or business. sale results in Ireland. $X.XX per of of income segments period On facility Both strong $XX.X operating of the across $XX.X during share gain per XXXX to million. our reported of compared basis diluted

strategy increase from Our COVID-XX comparing to execution the as continued well XXXX a from COVID-XX diagnostic testing the $XXX result segment testing as for reported the the Jon overall as outlined. from services of revenue XXXX financial revenue to decreased of higher guidance $XXX to than our due of million. variant, significantly services broader our third previously issued demand million in quarter When Delta

However, approximately an were improvement in we basis gross to of able margin XXX see points.

as health platform organization, Jon as team. invest including Scarlet our Health, We increasing commercial in mentioned continue commercial to earlier, our that digital well our GeneDx

$XXX We compared growth reported during opportunities. investments income with near-term of the these The $XX.X and third Total payment investments, a compared million million manage operating for diagnostic with under decreased XXXX XXXX million on to for from continue a these to the the Even non-recurring focus XXXX, $XX benefited $XXX income CARES cost the of operating segment to million of the $XX.X period. quarter million period. expenses to Act. XXXX period

RAYALDEE sales third XXXX from quarter the product in segment, Pharmaceutical for of to of Revenue for Moving revenue. compared price million benefited million XXXX RAYALDEE quarter net compared the increased the includes $XX.X XX% a of to $X.X $XX.X to D Medicare revenue Part the result which our sales we revenue of to $XX.X reported million decreased from of million, RAYALDEE $X.X of period million as period. in $XX.X rebates. revenues a from million XXXX, inclusive third higher

transfer LeaderMed $XX.X XXXX, pharmaceutical related for of income million million program. a and Somatrogan, reported mentioned year reduced Partially of facility of for international the our organization. an related we was businesses, as million $X.X included $XX.X Ireland, from in compared our XXXX that R&D segment intellectual million third the the as at and ago, quarter Somatrogan from reported by revenue. well XXXX of spending of pharmaceutical improved reflecting performance Operating research earlier. revenue $X.X as we As $XX.X operating fill-and-finish the reflecting decline of to we transactions $XX.X gain million XXXX, volumes channel When period on sale of our revenue look was operating RAYALDEE of from CAMPX our loss seen third expense the quarter and in a the comparable period our The million in for business. Overall million. offset have as commercial compared in to property, Phil XXXX development to well decrease $XX.X development

as $XXX.X under sheet balance $XX capital availability JPMorgan. cash us and of million resources. our XXth and million, balance our we and September of our renewed Our strong approximately was with with line-of-credit of combination a adequate provide have recently The cash-on-hand line-of-credit

the final uncertainty built to COVID testing million our looking have forecast. the PCR of limiting XXXX, anticipate and demands we assumptions forward are again flow, in $X.X and We see guidance generate to for into continued performing we $X.X cash fourth antibody the As the our the look opportunity COVID and quarter quarter. point-of-care fourth tests to between of given we the following quarter during million operating

As of Jon already testing XXX,XXX guidance. could revenue over October increase, demand excess COVID expand we’ve in our our well performed tests. Through mentioned, we have XXth, should these for beyond capacity levels

million $X we from of $XXX including million the but million. $XX Revenue be million, XXXX, for other of to to million and So million our fourth below the anticipate channels channels $XXX range remain our services fourth from testing RAYALDEE for latest sequential assume the revenue remain base on both XXXX. $XXX $XXX to strong. to $XX stable volumes sports, education We Based With quarter with to our at current of genetic volume expect demand trends of between the guidance general more levels. $X we comparable revenue and million. from overall and testing products leisure quarter reflect business XXXX will revenue and activities growth that, expect clinical public the period our of in of million during physician for remaining of and

amortization between Operating in million $XXX and be approximately $XXX ranging to million of of a include $XX questions. from profit well depreciation and We expenses to as research million and Operator? open operating With expect million. cost expectation and operating million expense, call development up that, of results, I’ll loss of million non-cash for results $XX resulting million. to as expense of the $XX $XX $XX the

Operator

[Operator of comes with the first Maurice from Raycroft Instructions] you. line Our Thank Jefferies. question

is line open. not Your

Kevin Strang

quarter Kevin this my Maurice. on Hi, thanks is for taking questions. on the for Congrats Strang and

the contracts professional on just from question, of contextualize your and from could reimbursement affected average your then First the these contracts came testing? including you how COVID much versus testing, how contract entertainment sports revenue NFL

Phillip Frost

So jump and take it Jon, I’ll you can in.

So break necessarily we retail down any is and during least recent channels, I But between from would the say don’t other half of in most it individual and business physician channels. about volume from what comes the comes other half the referral quarter. at the our

Kevin Strang

great. following get wanted your Thanks. Ascendis launch? And then announced that? just thoughts the for be you in on that Okay, metrics pricing, to going And to their are what recently

Steve Rubin

solely So, Pfizer responsible is of pricing.

we input whole So, have this of there point. lot don’t a really at

Kevin Strang

my Okay. All right. Thank you for questions. taking

Operator

Our with Sandler. from next Piper Tenthoff question Edward a of comes line

open. Your now line is

Edward Tenthoff

you we Great. Thank be My much. And do has releasing anticipate would with I’m get we that next wondering to should RAYALDEE When steps? what COVID. you. data format and Thank very what in could question that data?

Phillip Frost

for So, question. that thank you

the that database. publication, in the a time presuming set. we and process press actually cleaning the data form are getting as the data the come We’re complete before as in some the The well data lock of the the positive. of release a to of release will of analysis data It’ll be ready final

Edward Tenthoff

Thanks.

Operator

Our a Jeffrey Cohen next Ladenburg. line with from question of comes

Your line open. now is

Jeffrey Cohen

about what forward? Scarlet talk open market what driving if questions. your could growth commentary as Hello, for the you And of the the testing may about I about from you’re in mixed a can and prenatal in see taking bit as seeing integration thank talk going kind little far wondered [indiscernible]. you to triple-ish you the you there

Jon Cohen

women’s overlap So relative and groups. I NAP between second health significant testing the mean, I’ll part There there. take the to a is potential Scarlet large the

and have of areas you accounts groups. specialty of most investments. Many significant major quite four our make know those continue women sign one where are to those health with large honestly, growth are As women’s and of significant we

So result can Scarlet as with have the overlap effect. of a potentially that additional a

Jeffrey Cohen

the Was it. target when summer to got approved? do the milestone be [indiscernible] a well? same If expect U.S. the Okay, today? associated name And from in or there with the as you approval candidates

Jon Cohen

we same the is there So approval. with the Canadian be the And answer expect U.S. the name would miles no associated yes, to in the is

Jeffrey Cohen

looked upside beat is – either Okay, lines point Or it. on there XXX the call could perfect. a our trend like any was bit or or there the Got it could estimates, Adam, product then you little And through the on which any on specific downside? positive. go margin Is there? pretty looks out off to there side, areas basis

Adam Logal

Yes.

the driver within So Board. overall, prices we higher – any the net There were was it lab net business, there mostly was saw realized we realized one it so price wasn’t across on improvements. individual

side, was what similar cost to On pretty the past. it we’ve the in seen

the On improvement see result net can quarter during on as pharmaceutical overall see a significant. rebates Medicare pretty you we the volume RAYALDEE down, price script D Part as of net the was was but revenue a side, lower or did

started result of So a than higher previously of kind to net price off. a D what we’ve patients Part seen we’ve those rolling as realize

Jeffrey Cohen

Adam, lungs commentary buy couple I but a labor past you’re call issues, any arguably a lastly, for Okay. anything same labor the along you’re the months. And the me know or on test COVID softer out there over reference lines particular side, little That’s to to are helpful. on then in experiencing

Adam Logal

was more lab up add labor but it been a but We business during staffing the quarter. market a challenge can Jon overall. overcome the certainly certainly did it’s in color, tough third in it,

Jon Cohen

Delta May, of a to out you a of a going the as moving I of labor, had the started then because costs take COVID – recall we beginning as significant amount June the and were Yes. volumes would quickly down, by say U-turn end relatively hit. we

so through to weeks enough And challenge point people. rehire, was So We rehire market because four for was get in that it, got about to that a essentially was the people respect, we at labor difficult. it many tough. to but it had

Jeffrey Cohen

Okay. Got Thank it. That’s our you for helpful. taking questions.

Operator

from next Laidlaw question Jen Yale comes of with Our line the & Company.

is Your not line open

Yale Jen

the questions. and afternoon thanks for Good taking

the you I terms Do mean that next for for In year the the you have is million than testing X next more a to little bit a maybe that we COVID X.X the that assume continue of X.X or guided guys testing million resume, maybe could see baseline quarters for Adam, tester XXXX. quarter. into lower will a potentially few if

Adam Logal

fast to that going So slow really so you of Yale, just we’re And the – broader see difficult this grow that of into guided we slowing well, far we just quarter. X.X half how gave, that back decline. either a infection if the will X.X guide rates – the the or we you’ll to month testing to processed tests predict that, it’s over XXX,XXX and October, the or indicates of

good it’s next tough So to say what baseline year. a is for

higher demand is coming we’re we public our what pushed really had the with quarter. for the – but volume general quarter think in significantly the third comfortable from guide, pretty the what the than overall I guided

infection So to challenge to Jon, if it’s rates add. you basis, on least at the broader don’t to I have for anything a us. a know predict try

Jon Cohen

Yes.

an there’s as factor. think unpredictability said, I Adam

are significant If or the think what nobody going probably in happens probably that flu season, to the see a who knows. COVID largest whether flu issues increase want know to they of flu. I one And is people you’ll have there’s a the COVID significant testing concomitant gating season. with with

on we and into as will on the significant issue that’s impact months, year. QX get could So possibly – next a QX of impact winter which

Yale Jen

the is it the what be think the Maybe helpful. another you very quarters few year next line on acquisition, just this Ariosa Jon, over with maybe That’s the great. side, Okay, could that question of do impact next which acquisition? testing or top

Jon Cohen

moving what Yes. going clients of to in mean, actual revenue top up. as process, be. I I’m think will we’re not many setting them as line the possible over the I of as and number get soon of the into course,

women’s what right quick comment ramp be can’t of it I obviously will or the now. – don’t I but up organization significant about the is how focus yet, a So health

Yale Jen

maybe additional next great. Have indicated – last of the terms January the they datas request and what NGENLA, more And the sort why was Again, requesting? drug year. for Okay, that’s data pushed question next to the Pfizer FDA provide on the was the FDA of PDUFA the colors side. in that of

Phillip Frost

based request trust FDA timing wasn’t just data Pfizer the it’s It additional study this of was continuation a help upon since actually just delivery information. trial, abstract of enable

Yale Jen

a great. appreciate quarter. And on it. Okay, Thanks congrats good the lot. I

Phillip Frost

Thanks, I Eh.

Operator

I Thank no for you. Frost will to remarks. There further now back the turn call Dr. closing are questions.

Phillip Frost

participating. all for thank you Well,

end approval Thank end We’re growth in possibly. forward countries or all very to in year, to into approved next having of the the after early our year excited the on other We quarter about of look quarter. product and hormone of at Canada, next next with you. we’re the it looking as forward goes being you again

Operator

concludes your Thank call. Ladies this and participation. conference for gentlemen, you today’s

disconnect. You may now

OPKO Health (OPK) 29 Oct 212021 Q3 Earnings call transcript