OPKO Health (OPK) 7 May 242024 Q1 Earnings call transcript

Hello, and welcome to the OPKO Health First Quarter 2024 Financial Results Conference Call. [Operator Instructions] Please note, this event is being recorded.

I would now like to turn the conference over to your host today, Yvonne Briggs. Please go ahead.

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

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

open after call BioReference financial Before will Elias an And we Phillip then Pharmaceutical review and results, Dr. me President, business. first CFO, Adam and then Chairman Chief provide format the the Logal, by call. today's OPKO's and will open the for begin, Vice Chairman we'll OPKO's let of Health will Executive call. questions. Officer, Frost, quarter Zerhouni, followed to review overview that, company's the Dr.

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

for The Jersey. operations of of Health the LabCorp this is is clearance specifically March, expected close of to a But services antitrust an the advance agreement clinical testing profitability Diagnostics path expedited in York transaction to in obtaining to remaining clearance. the it segment. announced half our to we from to New references and million. also for and pending or afternoon, increase In second the include year, women's transaction assets regulators. joining you FTC so likelihood health and thank streamlines to of matter certain today. Good New structured was diagnostics The outside bio BioReference us for sell The assets $XXX.X

as once our launch product form chemical to weekly in In study and hormone be general, where peptide we the mentioned oxyntomodulin active This our to a new in call. in is have last II administering the PEGylated new shown has treating profile oncology is partner, at its is One I analog, entity growth were in deficiency Israel, which long-acting XXX doses. a our commercial development. safe PEGylated Phase quarterly the global patients. OPKO developed as global form to long-acting form over gain Biologics hormone effective other over markets. larger first same XX injection product now Pfizer, traction growth treat candidates The form expands therapy of form in to been preclinical obesity and continues under The the in permits of diabetes have this expected long-acting of

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syndrome forms develop programs. work and you oxyntomodulin to for look forward a progress other and We analog in with bowel Entera progressing involving promising our these We GLP-X oral short of to are malabsorption. with disorders nutrient Bio apprised of keep

this and the track development enter continues work ModeX year. to X its are advance programs to clinic on

Our clearance for oncology [indiscernible] Merck Phase received vaccine a licensed our FDA multi-specific has which trial. to antibody, and I

multi-specific moving financing COVID. to forward develop against is provides BARDA antibodies with and collaboration Our nondilutive

first on such begin as alternative indication, As biodefense influenza. this to to work progresses explore other tackle will targets threats we

to over Elias. it turn I'll Elias? overview, brief that With

Phil, you, everyone. thank and afternoon, Well, good

to purchase million health $XXX as testing of the Let and announce approximately were customer women's assets These sell patient apologizing the million. focused LabCorp me diagnostics U.S. cash and associated contracts certain services, for assets and in hear annual with very clinical centers, noise, generate with at background you include across New noisy and on revenue agreement Jersey. $XXX.X But certain health we BioReference but Phil pleased a start I'm our operating service assets of if to New by a environment York outside in said, price airport. of

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remains efficiency improve Our enhance productivity. costs, focus on initiatives and to reduce

we addition, higher-value of specialty expansion neurology segments proprietary particular in service the XKscore bolster our to focus and oncology In in coverage seek test. of our grow with through

XKscore first you As was know, a the in XXXX as test. laboratory test introduced developed

published BioReference's lab. roles know, a This FDA to reform lab impact minimal on new As of you will have develop the regulation test.

regulators tests New are exempted FDA State reform. As by announced who approved the all are York our from

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recent will panel new and turnaround we oncology, delay with onset with are RAYALDEE, hematological program stable most according demand, innovative to due may malignancy that analysis. to its of the grow the GenPath's very hope In which data to pleased competitive regard platform testing will dialysis an In continues a performance enjoy to plans. our expanded we with

We XX% versus in Much centers collaborations growth XXXX. XXXX this cancer mid-level QX in systems. our was with Oncology with continue of large to health over growth and through business strong growth volume see QX

able comprehensive health for As needs cost possibilities systems in looking the with oncology cancer for meet fast XXXX, timely now decision-making. are GenPath challenged which with times our to a This internal care. are laboratory across opening of has their and of includes internalization clients all an turnaround in they solution testing with late space, enhanced with business their reference hereditary QX for staffing and stages our menu up for been the to BioReference. work offers

expect evaluate in genetic cancer new of site QX We expand to guideline Oncology us advance current of onco components portfolio risk GenPath onco to portfolio our [indiscernible] our and complement recommended forefront continue enable and to which and the ecology. at tests testing keep will precision

New further and to with BioReference Jersey Testing expense Health Women's Oncology We with revenue reductions Health Similar OPKO diagnostic National retained after expansion positioned businesses, profitability innovative that Health for segment position boost believe divestiture. New is the transaction Oncology will on closing BioReference LabCorp. remain Health York, to our Jersey in efforts for our well of under will Clinical and brand to GenPath the these New an and upon the us York Complementing division improve businesses markets we further focus continue as a the company. enhance biopharmaceutical performance, best our with our New and to

Moving Pharmaceutical segment. our to

global is patients percentage markets drug Pfizer. well the positioned children. once-a-week daily product. launch As from major growth significant shifting you've We in believe standard of significant hormone all [indiscernible] heard, The this become growth increasing growth as global long-acting expected an [indiscernible] the has deficiency by is been progressing as treating long-acting launched with products in for and for hormone to

deficiency applications. combined, milestone In growth for additional our an Pfizer with and pediatric will in addition, additional X OPKO including these we these expect indications to million indications expand payments. with adults for to And approvals other $XXX entitle partnership hormone

go to Let ModeX. me

functional against clinical favorable antibody trispecific with date. clinical HIV. antibody and tolerated subcutaneous levels routes was the ModeX, well antibody progress a and per the X multispecific at multivalent we're latent with which observed system up strongly that to study to with and X.X XX in intravenous the most of proud standard antibodies minimal a announced anti-drug The activating and possibility both remained virus humans trispecific a development preventive our of to for antibodies from monoclinal HIV-X those long-lasting, March, variants, to the immune partners As data pharmacokinetic, kilogram similar we milligrams with and approach dosing from a therapeutic against for against the differentiated against and to our to ranging reported of Phase believe results therefore population antibodies. offer safe believe to support first with be I are multi-specific milligrams effect all In at found These consistent the further NIH administrations options kilogram HIV. per and will cure. We antibodies to

with this program. for partnered are We NIH

with in to a on vaccine We payment a million our from MDX-XXXX, double-digit vaccine received global $XXX.X development on is virus with to upon develop Merck is royalties this digit ranging single potential which percentages. advancing bar Our commercial plus collaboration nanoparticle [indiscernible] milestones licensing and multivalent upfront $XX plan. sales million

clinic in of this enter part timing, In the expect year. of terms we program to the this later

of source initial funding proceeding Phase and and BARDA is evaluation the multispecific nondilutive prevention an with a secured to million company. and SARS study of variants the another clinical for represents to against of $XX our antibodies on of treatment collaboration Our COVID-XX. non for grant COVX We fund R&D also schedule I

then goal $XXX efficiently to effectively of is with develop or body's processes, approaches antibodies production pandemics. other of as ultimate from delivery future biodefense used The gene-based methods multispecific mRNA against vectors funding target DNA BARDA using influenza. available to this natural such which the threats, supplement Additional may research be up delivery can to million and to to platform develop program protein a be and

by Rounding lymphomas. tumor tumors enter IND is studies immune clinical as solid are candidates focused by antigens the can immuno-oncology pipeline immuno-oncology out antibody system on proceed liquid activation. first the of for quarter hard-to-treat and as year. solid control Phil, deemed as target enable advancing better this program We we our are as FDA. acceptable clinic products our and believe such enabling our as and to is target the through application, certain Other next to tumors solid studies tumors which program, tetraspecific multi-specific well laser our tumors to expect focused on was several simultaneously IND enter on ModeX indicated And leukemias

with our several gain division enter diagnostic the segment while profitability year. of to So an its for execute this it's strategy as profitable you OPKO by activities, programs for exciting time rightsizing our as most Health see, areas to can to clinic set Bold we advancing the BioReference Biopharmaceutical

now to I Adam Adam? results. turn quarter financial to first the call will over Logal discuss our

you, Elias. Thank

the a align As our Phil to in research and convertible for refinancing to value discussed, maturities our provided of Elias and strengthening had some busy have cash The our January to our This significant the interest development from flexibility years. cash us sheet. year, realizing investments debt underlying balance offering needs we reduced assets over next the debt expense. and X our start

X%. addition, used by shares outstanding back proceeds to million portion In common of we stock, our reducing over of a the our XX buy shares

markets to We select our that operations at our sale was to us process. focus will to test of allow on BioReference. a for which the profitability to competitive our completed, And announced realign when path core with offerings, business and support also LabCorp and agreement assets,

to are are window then plan for profit profitability deal the on with we The the large first as diligently working as ensure and Federal the BioReference we get Commission, breakeven multifaceted possible. within to we step the in review While the plant. LabCorp was still quickly Trade

and million reported of from XXXX financial to for expenses million the Operating costs included revenue million quarter million XXXX $XXX.X Diagnostics Diagnostics associated XXXX million of with book approximately and decreased with business LabCorp. segment loss $XXX.X of this return respectively. to for XXXX employee related $XXX.X period. Moving $XX.X our cost the for our agreement and programs with to periods, compared nonrecurring sale related to amortization to related and is our approximately We for were to approximately that and million XXXX subject severance million of XXXX expense million. were $XXX.X million profitability. the Cost our included The segment. our $X.X $XX.X to to for Depreciation the $X.X QX results business of period. first for expenses efforts Revenues million and $X.X the $XX.X for

XXX than LabCorp our support of agreed transaction, to this employment the offer of part As to has impacted more employees business. who

from $XXX.X Pharmaceuticals IP period quarter transfer payment of as from our quarter, of $XX.X EBV $X.X first International of partially our quarter million, of of decreased to for from Israeli upfront our by for Pharmaceutical million by from as property, Merck a the the segment, the result to of million $X.X was first $XX.X for business, including for our Revenue from RAYALDEE. million our higher the API 'XX. XXXX million $X.X of RAYALDEE. to within Revenue Moving XXXX sales lower million revenue for an which decreased businesses sales milestone included well as $XX XXXX vaccine comparable agreement million compared partners payments products, our offset the intellectual of reflecting

in of cost has launch significant global December process first X XXXX, and manufacturing during policy. NGENLA the on to costs to difference months Pfizer inventory obtaining XX support scale-up XXXX, turn, of reduce for their of a of at hand by its the amortize able manufacturing quarter is of in NGENLA. the During Pfizer standard that of revalued accounting manufacturing order the their approval was substantially which In first

of their execution our in anticipated the gross and forward access obtained anticipated, to XXXX $X.X plan. the Pfizer we we for was first has period. commercialization quarter $X.X compares As a continued for Pfizer for million profit share the reported we share payer than and U.S. less which gross million, result, significant NGENLA in the look global on to XXXX profit from

from million million our segment addition, compared XXXX support other $XX.X and $X.X which for million Pharmaceuticals the and underlying approximately first Costs agreement program. underlying BARDA, with that includes R&D our our offsetting ended were offsets development revenue March expenses quarter In quarter for expenses of of for milestone XXXX Amortization million portion previously ModeX Research of were were their the for the for million included $XX.X period. this related development upfront million the the XXXX, million and payment quarter for XXXX million payment nonrecurring period. million to Partially at to quarter expenses for of $XX.X $XX.X $XX.X were expense The $XX.X of to $XX.X to compared of first our XXXX XXXX for $XX increased for from loss operating Merck. to income our benefited million resulting which for the The Sanofi payments quarter from intangible to activities this XX, compared decrease quarter. periods. mentioned, related in programs. unchanged first XXXX, I $XX.X was operating expense assets received of the both for

of the results, issued our value loss included loss change notes quarter $XX.X related an XXXX the XXXX of Net embedded quarter. consolidated our to first the with Turning to XXXX reported an million million approximately compared of on for convertible in for $XX.X January. derivatives loss to period operating million operating related fair the $XX.X

and on both For $XX.X recorded $XX.X and million our XXXX of periods, periods. noncash million, gains we in unrealized for investment the XXXX respectively, GeneDx

XXXX share $XX.X million of and per a with share, $X.XX net XXXX $XX.X for the this compares As loss quarter. quarter or million was first a result, of per for $X.XX loss the net or

ahead, Looking assumptions. guidance with the the following financial we're providing

$XXX of million For reported segment, not the our of payments profit there of NGENLA. and to from product of Pharmaceuticals NGENLA. reported has Pfizer, sales by were separately share sales that continue number from including revenue our quarter Pfizer for as GENOTROPIN are sales GENOTROPIN impact Global factors and XXXX from first a Pfizer will gross

improved estimate $XX million. by observe be scale revised for share associated with However, to increased estimated After gross globally million we and profit $XX manufacturing the impact NGENLA growth our $XX have consistent have million expected as between accounting continued for adjusting of versus $XX we the margins to for prescription IQVIA million and Symphony. reported previous our of to NGENLA, the gross

will rate We U.S. also growth. ex which assume allow exchange a U.S. for profitable for our stable foreign pharmaceutical continued businesses,

the to expenses portion initiation XXXX related continue higher our R&D activities efforts will related agreement. reflect quarter BARDA second these to CMC first programs, clinical A for ModeX will of and of immuno-oncology including funded be our through trial. increased the of to our activities to

closing timing remove to not business our from our LabCorp we the our certain estimates. this is our second quarter review, our is transaction not adjusted for have segment, yet to subject For as FTC and of Diagnostics guidance

rationalizing we're XXXX to achieve run which and structure support strategy. outlined, continues end footprint to appropriately we've of the This we business offerings flow subject work as of geographic the our as closing in and structure rate profitability cost the align our working rate consolidating breakeven year, testing As middle our expect by to of the go-forward to cash our transaction. client LabCorp the by are both include run timing our of our mix cost our improve to to

During consistent testing patient average due slight management collection expect we the to amounts our volumes this transition with revenue core per in phase, cycle price increase a initiatives.

that $XXX expect and the activities Before decline related as expenses, $XXX approximately restructuring considering giving any million costs assets million QX may to approximately to $X to to our approximately our by million transaction. expense the and nonrecurring cost without million in of result to part LabCorp other from the nonrecurring $XX effect we

Pfizer the and are to $XX and million million between between gross inclusive sales million $XX share Total which and revenue for profit quarter $XX million related $XXX transaction, million, $XXX the revenue As LabCorp between $XX and we $XXX the product million services and expect $XXX from $X assets of result, second other million revenue from a including million million, $XX of to estimates, $XX million following XXXX. from $XX million. to between the revenue million of

range for well expenses again, activities will is million, also We CMC of excluding amortization million to the expense. between expenses quarter approximately to timing and nonrecurring costs programs, of on certain $XXX include any second be expense $XX restructuring of million It ModeX and million. The million and based expenses as our depreciation $XX expect $XXX related and for R&D as BioReference. to $XX

concludes operator, prepared Thank for our let's remarks. questions. That your And now you attention. the open for call

And Raycroft comes with Instructions] question Maury from the Jefferies. [Operator first

BioReference. related going was I question start to to a with

Once of services into both provide and what's With optimize value to BioReference breakeven the streamline, with And to able deal sounds remaining strategy timing closes, services business pharma be you continue it and more you parts aim LabCorp like that profitability? for clarity to the maximizing profitability. and company? get grow getting the business, longer-term to will to plan for to for the the

So Maury. the I'll take first question, the for Thanks question.

So us for the our as to going We're rest cost also help fixed exiting will down the tied is currently, we're facilities LabCorp of transaction. timing bring working -- we're breakeven we're getting to it the relates realign. be not not overhead for to and base waiting the business, to which continuing certainly to fixed certain our actively that we're

would run think that executing longer. us the Obviously, I Our goal that path to expected, we're than looking rate midyear, have otherwise, we're be longer But to the plans breakeven then cash could was takes if on. stated still that's flow have that. take to FTC towards

then And profit more the NGENLA, there gross for change or and Understood. can guidance the it. Got clarity there? you revised into provide any perspective in

Sure.

improved has their gross to inventory the and just been consequence the to to no do Obviously, reflection guidance of timing has the strength accounting of their Pfizer the global gross coming the realize margin to when seen share on on of So change to demand longest. basis the revaluing profit that benefits program strong market they NGENLA with from going overall, an through do scale of some has our that's best. we've a continued be had continue it's in we're the that flows Really, on up. on books the where

data can if And are the initial if question and assets. year study know some specific should Got for maybe XXXX there that it. moving on, I clinic. see on from there's just when ModeX Understood. of say catalysts in about this could we focused anything particular, the don't that? we into more that X you clinical be

I'll line, question. specific [indiscernible] let Gary the answer on Gary? CEO the who's to that

Yes.

mentioned, we go. Phil green the As have light to Elias and

sites we're really and So to patients bring the into trial. moment, at up looking the setting

the it hopeful by sooner to comments, I his think and if make should the in Elias -- the happen quarter, we're happen as working said end we're possible. this of

In taking that as FDA. terms for dose of that's and the safety results, with dose therapy craft we've you with you you're a low probably reasons, whenever new know, into plan you a the really any and started come escalate clinical clinic, to immune a

on So for certainly is to I type of expect wouldn't least time results. in might which probably efficacy, next see be expecting some to the see year frame data at you any

question & Thalmann next the [indiscernible] comes with Company. from And Ladenburg

will A few mentioned as NGENLA I from that about for additional the the wondering as or if studies is expanded paying our end. was talk be we could Pfizer who and couple you far labels yourself?

partnership indications adult, our way But expecting necessarily additional cost the we're for with split the not XX-XX we're Pfizer. the those will works not studies. is So -- additional any

for just pediatric the So basket.

quarter, Got Okay. what BARDA first that? should in anticipate should we out 'XX, extrapolate know full for you the called And we reimbursement. from it. I X.X year

expect -- continue to up, to ramp We Jeff. you'd that

part the it they're there's why line, number up. on slightly will line that's reason do up, of just ready So expense going less $X.X revenue to activities, is CMC the getting was that reminder, And as numbers million -- that. some the a than bump R&D which the

Yes.

clarify it. cash makes you sense. and debt. Got on just And can That the Okay. Adam,

So debt it the XX.X was cash and plus side? XXX on XX.X

right. That's

half Okay. right? will that anticipated gross have -- it LabCorp back And we number, the It's like year, closing, and of by or sounds expecting end be you're the XXX.

the the large timing is just unknown on FTC. Yes. mean I

clear working we once will the assuming we FTC, So quickly FTC transaction. be core the with that clear

Okay. Got it.

optimistic on year? back of You're half the feeling the

That's our expectation.

Sandler. Tenthoff, Edward from next Piper the And comes question

one, just a First, Adam. quick

the guidance the get I didn't to? mentioned furiously, for And but second of writing was quarter the number. cost XXX I You

XX. to XX

assets? think if helpful. is mistaken the X what And for be Merck Should tumor? partnerships about higher expect year's these and more or with level, different on stuff BARDA, and clinical data Great. the Appreciating you partnered? under do that expect what next Do plan saying expect at level higher do could of a cancer a to commentary kind MOVE generate cancer more Elias stuff moving deal? sort I keep higher-level further what ultimately then we solid EBV And The were hematologic of is? that question. I'm Super you to first the Okay. just like the is some multi-specific not Gary getting the antibody

happy with be I'll that.

the Forgive noise. background

I have think okay? tumor several solid it's the are a quarter, do which a we are to this We that tumor molecule, molecule liquid entering with parties clinic who we're interested. actually discussing

the I X we we are a of vaccine -- things, scheme actually -- in X of we the X. a platform are the have lot think in grand interest. platforms, a eliciting multispecific and And

and partnering the in our interested will by enter third parties, to could be research market than what afford own. in more are develop collaboration we larger a targets where funded could we of that portion We especially on

I this data. one, through us So we've it's going increase say? bandwidth. through Gary, here. I -- for and results to the with hopefully, parties the much the have and the to that think trispecific with had for to will our EBV we licensing if I And the generate momentum results I'll leverage already And Phase ability you a stop want collaborations to platform with think with

Yes.

patients. we're that of these I advancing approval can in sense it to I terms makes well, say, them and Elias. said whatever think to products getting Ted, you open to

higher take advantage parties. can for them we and we third the our that value is individual having some We can then And of with and platform of partner reserve take some, can [indiscernible] commercialization. a forward path those well. products as that they think I have

develop the partner of would to at the I we'll but than suspect probably very open we're more we collaborate. will that day, I end -- So internally,

I the you antibody Well, all think makes doing that be multiplex engineer your when who the sense. to of looking and empower I able big you oncology different sense, can different to mechanisms. you of too, That's agents the group who are a makes lot on combine own. players multi-specific that think really is analysis a a a lot into ways factors And lot that combinatorial at some guys really think bigger do for to you'd of about these

appreciate about for really saying I what Sorry, platform. that partnering you're the potential

And Jen & the comes Company. Laidlaw I-Eh with question next from

regards enter Two questions to the soon. all product ModeX clinic to in the

The first vaccine developing the competitor a virus X question of my target. also against is vaccine. EBV And same is for the Moderna there's also the

on So of question theoretical how Moderna? do a that you compare is to at I that my ground, least Then question. yours have follow-up

answer mean the better, just Gary simple I'll is Well, let we're but I the kidding. again. I'm specifics. you give

the knows more just back, real actually through products gene managed good have the out Moderna same is almost perform thing good step how world. never of engineer for mRNA, delivering the take to the will Well, we've say to to a the I'd X actually onto it's they being to in X that ferro than nanoparticle, a product patients, there tested because

nonhuman we it's with preclinical is that protein platform in strong. model adjuvants platform we're favorable our The primates that the using I think are humans. safety is about and animal a profile very that described our like in looks a and and what fact well data

well pretty -- following responses path set nice to looking at with we're immunogens where I with of and biomarkers prescribed so loads think viral we the you're when a a And and virus. immune great

vaccine, we some with So it going a unknowns, more issues more with obvious, program. using will I I in want alternative that pretty just to as terms regard has an is side and feel say advantages platform, mRNA But different the using our more of particularly important. therapy. those into some fast, platform has but what that become the good details And get more really you is product. to which and effects of they're of they're patients don't a begin the treat about to the

like the But way ball better. ordain we about good a the where so have for the to feel to cause and about address, to would have platform to how And work this of of a that of experts bench no vaccine. the there's or vaccine trials ultimately reach and how real with partnership or to we what which aspect cancer the will unique the expand and to cancer have expand crystal Merck, pretty they of is the knowledge which we

-- So the I do best right can that's you think for I that's now.

are Okay. a target XXXX. could X Great. targets of here. That's study very more and maybe -- any give in helpful. lot design terms the us by you Is being this the just details That's pursued some what detail Maybe anybody? about of the

Yes.

with a tumor list be the we our expand on We will that near target, more to be of surface breast, to out, line a are types. the and about bears trials up the types tumors. within include lung, the in tell we and consumer we but cell prostate, in is efficacy will, stages, goes first There's tested. haven't types express some enroll those they signs we'll these them large malignancies can number probably markers patient. on. next tumor found the where I the those solid in we seeing for a formally But picked antigens, looking what disclosed of There at future, variety And more the types. few efficacy. is And disclose look XX fairly pancreatic might time, initial we'll tumor as that of that on we you be of actually that list And a if seeing number and then X X where focus weeks we're

And the to helpful. move congrats ground. Okay. Great. program this very That's off

it very to to patients. get We're see you. Thank excited

Chen from with question next the Wainwright. H.C. And comes Yi

solid to how you I trial trial? tumor for -- do intend And up enroll is on trial, many this follow all-comer Just MDX-XXXX. Phase an solid solid The patients to the tumor correct?

is part. broken trial into The

a and Ib, Phase at group Ia there's we on will the I'd will Phase more that will look multiple And begin different where a Phase after say where Ia have then we down be ones in the point, So to types. we the activity. drill then

trial some have number. we We so assuming includes will clarify, a you then said side I again you we decisions I would earlier, I be they next really tumor XXXX. would and be say we approximately said what had get to a stand think escalation follow available first, just didn't then by would you're until for the period does see when the expansion, to to to you of that. expect take available dose that we because where type. and be able reach be a them would effects don't the before in then but I the any to the close patients treat will and patients have a larger and in time. Phase what in dose to you as to point I XX think to do then from did results go some say year that that And we level preclude or efficient not with that And agnostic the when enroll make while to because then therapeutic slowly further won't to therapeutic we probably It

what year. it year. even doses efficacy will I see But We data, until have next of well data. to patients. that start into begin expect is how and signals the to That us expecting think, tolerated certainly tells before So seeing this don't we'll in early end well safety I

And could before oncology stage to end clinical the candidates it. of bring how you intend that of Got development XXXX? us idea into give some many you

be would say range -- have of to that X. we it the in X I will

think clinic may some on depending I X. enter the by then opportunities have will will next another be likely that partnerships, advance year, there to very we X

materialize here? that And Okay. to level a partnerships, Phase need partnership II for generate likely you is to data will proof-of-concept it

Elias, would you like respond? I -- think to

than I it patients. start just no. oncology to that in clarify different No, areas. In oncology with other in very wanted it's

need don't a data partnership. generate II You to Phase

some to of Phase and a strategic in attract you Ib what don't should I, you to [indiscernible]. areas, buyer be II in do trial Phase know like results need to a partner need we're beginning need demonstrable [indiscernible]. looking would to I but in basket major a You II do have a to other don't

No, I very much agree.

I. transitions. of Phase in in terms at depends we And can don't you partner make in instances our where to signals then you on think I that teams oncology, want appetite to those often begin really of internal the the just and really what in of point see

and II. answer So somewhere say Phase between I Phase I'd safe is the

Petusky comes Research. And the with Barrington Michael from question next

months data, indicating slow some have -- been going we've this I the sense folks for mean just the if may really that said, to got this really are could guys may I'm just We've even RAYALDEE we evidence you that a with or guess several hey, to got "Hey, think This your compelling. give I able months sales few got about of ask there's you maybe kind yes, this and some any really want product last the we've And reaction product least data. just at can anecdotal evidence I of sense this is progression. matter." any CKD I curious, a mean, is unlock that nephrologist this share forward? there or

I by our expand of not as it's telling clear own data on more. X the as generated was this real-world delay the that we evidence could I onset from that that can that. very you well data if from dialysis year mean months,

to of to Now CKDX. of publishing, really obviously, that. the And to indicate really that because have be we [indiscernible] KOLs shown delay therapy ability also and other nephrologists, for in will really we're has presented which dialysis biomarkers of a do difference that secondary terms that but the no the ones makes reception are it the the the the the shows RAYALDEE onset it patients

of it's dialysis, a think answer, we into the to X. that see the valid patients to out lot CKD is see go yet. to sales are talking there we just but likely the So not the It's nephrologists, force also late-stage CKDX

and story evolution. a So

have we treating is answer it's which on going impact be reinforces And hyperthyroidism have been questions [indiscernible]. so the this that secondary it evolution to point data have the the outcome. the of change does to a always think of that an was we and has reviewed the is patients disease, the X And I far.

in you to mean how docs seem and talking to slower should I you they than -- ask a like sometimes Can okay, about years seem this. rather behavior hey, missionary of data quarters it's or I a than matter I changing change and that, the to current logically mean, mean published follow-up effort I compelling? this to a much so data of really behavior move is of if In that that? of get or terms behavior. thing start the really the terms prescribing they kind just long -- things it's is

medicine, the X I [indiscernible] RAYALDEE the to they clinical now. make is It's Absolutely. or to develop. year question. the time guidelines. that right medicine a mean, you're it mean, I guidelines in before talking about caters guidelines

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the to any floor would I Phillip to concludes question-and-answer comments. for like this Dr. Frost the back And session. return closing

everybody we at very Just want with to participating together of for to you again And your for and next discussion. good the questions thank look end forward and being quarter.

has concluded. for Thank you. presentation. attending The conference now you today's Thank

may disconnect. now You