ADMA Biologics (ADMA) 8 Aug 242024 Q2 Earnings call transcript

Good afternoon, and welcome to the ADMA Biologics Second Quarter 2024 Financial Results and Business Update Conference Call on Thursday, August 8, 2024. [Operator Instructions]. Please be advised that this call is being recorded at the company's request and will be available on the company's website approximately 2 hours following the end of the call. At this time, I would like to introduce Skyler Bloom, please go ahead.

Welcome, everyone, and thank you for joining us this afternoon to discuss ADMA Biologics' financial results for the second quarter of 2024 and recent corporate updates. by Tate, President Treasurer. Chief today Officer; Chief joined Brad and Financial am Adam and Grossman, Executive I Officer and

today's progress, provide an will the company's provide call, comments XXXX of During provide financial quarter and results. an some overview update then and introductory corporate second Brad will on Adam

for provide then will remarks Adam brief summary before questions. opening Finally, some the call up

updates. XXXX The press financial issued is today, a release and detailing recent second achievements we our corporate and results on quarter release summarize available www.admabiologics.com. website certain Earlier the at

purposes that we will today's under provisions formal Before company's concerning statements XXXX. our comments, Securities of begin Private represent the the which that making I'll intentions, Reform during the remind assertions safe events, Act you or of beliefs forward-looking future we harbor forward-looking expectations Litigation the be constitute call for

to may subject in and and are implied which filings, today's statements statements. results results by from expressed such release or the such detailed in announcing press forward-looking factors, this call to differ cause as SEC those materially risks All actual our uncertainties

statements any forward-looking specifically any any upon and except statements, obligations the Securities representing as update by relied Federal views as not our of We Laws. this addition, In call of the should views our such any as subsequent be only date. of date represent to disclaim as required

go from that in statements. disclosure the to could factors June to you for quarterly Please the a XXXX, ended section comparable discussion issued XX-Q notice EBITDA. to section forward-looking these call materially Risk on results actual Factors of turn XX, the including in GAAP the release over discussion With metric non-GAAP Adam in of today quarter reconciliation refer call earnings Adam, differ would the We available directly to Form earnings cause release. on these like report that, our non-GAAP we important of for note our ahead. A certain our now the measures, includes Grossman. most I to measures that is -- today's financial financial adjusted

Thank quite eclipse you, calendar million a to welcome, call. today's to during in journey single has revenue been and $XXX everybody, quarter. Skyler, It a

We are fastest-growing that truly and ADMA expenses ADMA the profitable is extremely applaud companies managing earnings salute milestone such positioned our this date biotech have among sector. while entire growth to I to and remarkable, proud achieved the the team. in and It

by adjusted coupled Our forecasts. unwavering exceeding results operational tightly financial commercial, commitment to million. quarter, year-over-year, impressive the during cost XX% revenue This year-over-year. GAAP representing growth, strong loss grew $XX.X for a structure second grew rate GAAP $XXX.X resulted has growth and the income Total once same in analyst yielded million managed second period excellence reaching last $X.X revenues quarter again of nearly the to to in year. net net the quarter a XXX% million, $XX.X during compared EBITDA of with a million

will Brad delve details. into While, the

accrual quarter reversal, increased from reported earnings. onetime a and revenue This benefited both which

able be gives is will significantly this strength our lines from grow, baseline. in to that of impact the favorable this the confidence Although bottom underlying nonrecurring financial business us and both top nature, increased we new

total upwards $XXX million We on and we XXXX. XXXX XXXX more revising Based current both for financial revenue are million market anticipate XXXX. for $XXX our and now again conditions, than generating for guidance of

year-over-year million $XXX representing growth for more adjusted we income respectively, than are and estimate estimated EBITDA for exceed and a 'XX, million rate. At rate. to will these revenue $XXX increasing guidance 'XX million year-over-year an Similarly, growth XX% and reflecting $XXX $XXX for XXXX million net levels, XXXX, we XX%

And the by to continuous encouragingly, product proprietary both immunoglobulin demand and the new breadth targets forward-looking ASCENIV. these achieving growth of in is for depth continues confidence highs. base of All unique prescriber a financial ASCENIV's underpinned the our strengthen. KPIs and rapid are and Our reaching

ASCENIV, surpassed the and meet of to tighter favorable the has continuing are a implementing and plasma, for to To ASCENIV report the XX% raw a further for pleased contribution company setting our am ADMA's mix result, availability growing we shifts. demand measures increase stage a total I anticipated ASCENIV. we capacity for production As now significant ] [ revenue, to milestone marking are shift to material high towards

to initiatives. contribute in due our progress product And believe majority making to the has are when with completed, course. total these revenue a We we mix ASCENIV significant potential

to market, our therapy and better throughout visits XX,XXX To is co-morbidities, patients, office billion position from require often focus conditions, These unique refractive multiple their unable steady consider immunoglobulin U.S. risk-stratified critical the health these to within immunoglobulin standard it $XX suffer complex exhausted conduct of reality concomitant the multiple The to have daily therapies failed doctors' journey. immunodeficient on their treatment including who medications. and and growing complex core patients due patients additional understand is regularly ASCENIV's are lines school maintaining attending to or potential have and employment growth hospitalizations. unfortunate activities, XX,XXX

the inspiring compromised and is this deeply it in His stories like in our mind. settings. patients to on ADMA that therapy. precisely suited treatment highlighting remarkable clinical and real-world ASCENIV immunocompromised XX-year-old has released built cases. principles challenging product resilience with new unique both quarter, these further has use success address the the of of the fuel composition proven ASCENIV's To of IVIG journey proprietary improve resonated on a And illustrate, The organization second of to story during continue immune we a to to be were website, patients. commercial well founding lives patient video patients, the the testimonial

of meet and is our outsized within estimate that patients are date, with reach. still the governed growing to ASCENIV target to the which we much done, its less demand. largely penetration X% is to many of ability yet of population, total patients market core been proud than ASCENIV's current product While addressable has by work have be we to We are there treated number the there

We guided are create with that beyond incremental additional the peak penetration accelerate substantial our opportunity near-term baseline. ASCENIV revenue revenue will confident and XXXX

us like treatment produce I say ASCENIV a that launch. its are to ASCENIV would will to context, focused In and option limited at tirelessly is unique extremely demand. and potentially more outsized PI for all life-changing proving of before the alternatives that to who be to meet work ADMA patients had

production Given to approximately yields have this new yield the commercial context, production starting potentially our XX% XXXX. demonstrated manufacturing drug potential our of Recent our advance enhancement enhance same from immunoglobulin plasma. innovations processes efforts to of through scale bulk continued processes more in in

the And are realizing as to anticipate revenue further as subject initiatives accretion if and the potentially course expected then benefits late beginning, we transformative to These regulatory over approved, year, early with next review. earnings decade. of accelerate evaluation and

we appropriate, to of formally the As regulatory and and magnitude benefits will timing progress. these operational guide as developments

and across growth which to the support reaching our to positioned the are believe are continue positions success. to On we forecast well, We strong highs. with for increased growing perform we supply network are demand us portfolio. new believe centers future collection our volumes foundation a continued increasing and collection for well collections innovation production for our IG meet front, plasma Hyperimmune plasma

platform. learning to and Moving machine AI innovative ADMAlytics, our

results, in the enhanced solidify production optimize including growing into growth We planning, expect of quarter. the implemented, to outlook. successfully Initiated staggered pooling fully yielded commercial operations XXXX, variability implementation the second rapidly the When earnings are to and strategy. our during we in rollout already further expanded technology increased has ADMAlytics February implementation efficiency, commercial to the impressive hours. These visibility streamlined commercial of the our efficiencies our process, of plasma manufacturing reduced FTE expected optimize

Our portfolio medicines provides significant of unmet diseases benefits to with patients, need. life-changing addressing

We are donors patients, for of public make health. proud we the difference and

is team, our gratitude the employees, for drives of we makes our our workplace hard significantly dedication, collaborative that unique. this helps spirit exceptional our those steadfast progress Our to your heartfelt extend accomplishments and serve. showcase we and which work commitment our It

And said, XXXX for financials. the turn I'd to like review of second a to with call quarter the Brad that over now

We issued results. press Thank a today financial second our release you, earlier quarter Adam. XXXX outlining

we'll report afternoon, during discuss of later the we quarter. call. this our highlights We will in would which be points the encourage quarter I'll conjunction the now from also to you some discussion second make issuing financial second key read and with comments today's XX-Q

ended June XX, ended mentioned, $XXX.X million were for Adam revenues as quarter million $XX.X an or of total XXXX, XX, compared the quarter increase June the As XXXX, million for $XX.X XX%. approximately to

growth related to addition of results an rapid product estimated In quarter, the products. ADMA's to Rebates U.S. were reversal immunoglobulin second accrual the for impacted Medicaid during favorably reported historical commercial by revenue

ADMA's time are newly drawing the ADMA's on legacy in ASCENIV evolution increase that product accrual commercial when the basis. operating corresponding way A uncertainties existed BIVIGAM, utilization that review and consultant last half $XX.X With methodologies ASCENIV a history, with a time developed reduction By were BIVIGAM. their the net drug a ADMA to second confident years growth commercial commercial and for any for appropriate assistance X conducted inherent significant of the quarter, launch certain implemented to initial from during go-forward lack launches commercial recognized of the background, of and of in the a we customary methodologies of balance. our million and are a revenues of in at accrual third-party XXXX

the ahead. periods XXX% $XX.X to quarter an compared trends that $XX.X million of to earlier our we confident the XX, profits XXXX, this and for revenue such remarks, increase XX, while our GAAP $XX.X strength for accrual the an newly both ability quarter of reversal were are million XXXX, nonrecurring gross baseline financial on build million this the established as June growth ended and To reiterate is rate. in Adam's June in business in nature, earnings ended underlying or are approximate grow

corporate in XX.X% XXXX. quarter XXXX, a second achieved margin to as of the the ADMA second of compared XX.X% result, a As quarter gross in of

as managed. leverage are progress our financial we XXXX, just expenses demonstrate capable is grow realizing we distinct are to business continues to beginning into that the and believe operating results we our As revenue tightly fixed of that further generate

quarter the adjusted XXXX, or EBITDA of $XX.X for an as compared million million quarter, of increase was June $XX.X During XXX%. XX, adjusted EBITDA million nearly $X.X to second the ended

Additionally, quarter June million income June of XX, GAAP XX, XXXX. ended for ended quarter net to net the loss million the $X.X for $XX.X was compared a GAAP XXXX,

adjusted strengthen leverage EBITDA We and in current the augmented flow the time significant the continue $XX.X on to Based flow second has cash sheet growth, annualizing forecasted company's second the approximately anticipate EBITDA. of and to net will $X.XX million of growing by quarter organically the quarter ratio free free robust balance over adjusted improved generated the cash results. the period,

back that, now closing With to remarks. the for turn Adam I'll over call

innovation company we believe success. performance which to Our creation, value our and significant continues positions growth enduring and commitment to drive for

mix favorable and Biopharma United of and leading States. profile Over XXXX the as shift the of in anticipate we profitable remainder continued growth one 'XX, ADMA and fastest-growing the positioned in into earnings revenue that companies

With growth approaching next believe the on net of embarking from a EBITDA we position debt cycle we to X, phase of are our strength. adjusted

committed sheet, balance and are reducing value. fortifying maximizing of shareholder to We capital further the our cost

beyond commercial provided innovative manufacturing unlock XXXX, our model, a peak currently platform plan be revenue on higher R&D and levels to opportunity may leveraging specialty which potential our Looking financial reaching guidance. we and multifold than earnings

story to With We open continued write Operator? unique call continue internal longer-term success. the up unfold. your the Thank now as we'll formally that, questions. dedication. you of Together, expect and we support provide developments will for for guidance to ADMA's

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

the seen Congratulations, in Adam, time release, a the team. ADMA in XXX% rest plus impressive of very growth press the Biologics EBITDA. and a I've first It's to performance. adjusted Obviously,

congratulations. a line, bottom milestone on top obviously, the and quarter So

million I'll of good and Adam, Maybe a counting beat to XXXX mix midpoint the What a of what growth us could looks little longer-range to if Give and the the in If we're that quarters updating on company X-year have of bit do idea a go-forward we're 'XX accrual XXXX? raise, this plan the obviously growing an now How peak back of beyond quarter, of And has base profile been sustainable is and levels. the rate potential, here have like shift P&L follow-up. And margin higher to top $XX levering that forward outlook X maybe the line the start, is a for any company sort ASCENIV? you we think out helpful. you would at of consecutive the and profitability XX%, thoughts be? be the you're of 'XX. in

company got is people. We look it. is I a Anthony. that product, you've team story The great when -- really it helps honestly, a happens, really We've Thanks, make good heard talk this you the last X-plus working here. believe lot it's about a appreciate the I that quarters. me And of over mean very calendar same efficiently. like what

So all doing. of we're we're that very the proud work

a me feel taken, feel is guidance but I've good given. your we're same we've always We the we've for forward to that guidance asking that's You're job. said We guidance, taking in what the something and approach question that say I'll like the past. about that

and here, place as can. much we products. XX% proud to make goal the as where in always to contribution goal possibly our been a Therapy we announce for Our We're passed can that has ASCENIV unit the business the has mix of be ASCENIV

line decade line throughout we forward-looking think and our And continue rest the to can and bottom top into future. grow ASCENIV and this of drive growth. the

use is And the look, we've and XXX,XXX, appropriate that XXX,XXX that truly we capacity roughly plant liter got we've have IP a said that, making As product we've said, differentiated mid-XXXXs. into the identified a believe I we've in here. past we're got protection

X You can plasma grams IG math you liter, in take produced million, per the X.X of plant. roughly X at grams this million

was you're peak total in revenues. at $X of than billion, maybe ASCENIV, more All billion, that looking $X it

is again, to do. that that, not this I'm saying I've that. not what Now is happen, but going to I'm this here before, to we guiding are said --

got said, One that hard is is more been the we're That's more governor. collect We're and really more plasma. that collect we company. the you have the We're working plasma. come hard here. growth why folks through to to This see to we've change here way. so this quarter-over-quarter. our worked really It's of all that patients. hurdles and my We started hoops our the jumped Really plasma. we've believe an ability why for outcomes opportunity And collecting growing

more working than are efficiently before. ever centers Our

well. continues third-party performing very outpace But very, supply. demand to supply Our forward-looking been the contracts

our going driving forward. And quite what's frankly, optimism that's

obviously, decade, great got So different we into years as light for time. of the sector several the the right believe now. outlook we we scale over a we've mean, that in contribution the next see yield enhancement, the the the But most from compelling here. of I which look in announced into visibility growth story first part at it's back ahead, today especially a we

So it all. question. very answers proud Hopefully, your that of

bit just And a on Absolutely. a quick just follow-up the patient Maybe experience. on ASCENIV. little

give between helpful. just Maybe highly When like be improvement would hospitalized? words, are the not on it ASCENIV. other these it's do once Like these idea patients often what how think, I ASCENIV? And a they're on an they're patients patient. In how stabilized time compromised extent us do exacerbations? an get to see you in

has So journey, on immune-compromised different. to is been getting responds IG patients different, and path treatment environment the everybody's every Everybody's IG to differently. everybody

a really there. very it's you to So hard specific give answer

immunoprophylaxis. through your XXX, are those patients immune IG body's affect genetic primary immune again, XXX X they ability the passive replaces, produce But antibodies that and diseases, antibody compromised, got of deficiency, to different

every rest their the to at X looking of remain they on life, X IG. You're for weeks

testimonial to have our really spoke patients who patients videos -- this proud I of patient the we're XXX,XXX, during really remarks, remarks, done that United very well. there XX% increased. States. immunoglobulins, of therapy. about had help. it and it these are dose XXX,XXX with other lines clearly prepared the not to the in recent failed that testimonial overarching to targeting receive I the of XX% are They've the They PI about most that XX,XXX identifies We're their We XXX,XXX have in multiple XX,XXX prepared to patient think We're quantified trying

X% are at time. this less X%, little than roughly about We penetrated a

we ensure a feel the regions doctors coverage. we're We closely patients We've position real-world know therapy. where the this, [indiscernible] to payers great with patients on capitalize the lists of growth. with experienced in know for We've we're have that got and patients, the really on that identified we working patients and and are. And to outcomes great very

place. into falling all it's So

forward this I here, like said I've for a We record, Again, really feel feel we be sound the we're that early beginning us. days looking it'd we're to but future. I and broken just before. know

from question the next of Our comes Kristen Cantor Kluska Fitzgerald. line

for is Rick Miller This on Kristen.

enhancement On Or to this you with? relates ASCENIV of boost with specifically working production as put are well Biologic that Does across mentioned, pipeline? How context is yield there the you're you thinking product? the can it this? sort specific product the into the dovetail mix something could that this yield about you

question. Thanks, much Rick. for Very the

make normal plasma, what source what make. made from [indiscernible] using before, that high-titer same really products. the from care plasma. and hyperimmune this said [indiscernible] We I've We thing So the day. doesn't every source we plasma [indiscernible] is began the It's plant starting differentiates [indiscernible] the the with plasma

Yield is they as ASCENIV being production. enhancement specifically targeted began a to

we same products anticipate both will that drug feel the So experience products starting XX% regulatory both be more approved review, we after bulk should process the from plasma.

X said about So per I've roughly historically, liter. grams

yields been So where is drugs. historical for our both have

looking you're near XX% to some all looking of going and have maybe of go approval us we [indiscernible] regulatory donors well. review late X% is think back, that the antibody and see mile look less that we're very testing next Rick, mean liter proud term. half to drive for. the it's the but that. pro come of feel ASCENIV, help have line, that of look, growth, we're This to to again. towards collect, at plasma very Should we should we through as This decade So because, I allow maximize especially confident start accretion this the every for going us year, is to adding XXXX we'll back you we the than

of all development our we the team are forefront, this, valuable, is donors is plasma the donating [indiscernible] we're you really is valuable. on really So that process finding if will, these plasma donors, our excited their of proud here. we're in improved to plasma think work really with a process lead commercialization. a here enhanced fractionation a yield or the they that the We're thinking. And yield do perspective from And forward I bringing

that question. hopefully, answers your So

And a if may. Yes. follow-up, we

You could a look like can mentioned side anything Is what here this you say there about yielding the it. pathway of potential regulatory process? with regulatory [indiscernible]

typical is supplement. prior understanding this is My approval Sure. a PAS,

comparability all and some ASCENIV to that we're have for our steps things in with FDA-approved comparability improving are comparable process, both these Xdemonstrating we're we what current different and existing protocols. at BIVIGAM. modifying that So running BLA Showing our and

complete We'll package data. submit a we'll typically review. typically, submit So lot And approval supplements are prior X-month the the agency. We'll to conformance production.

So apprised late forward. But we status early will 'XX. as get very very, hard to we're keep the our can we sometime to next or year working market have approval an move really of where, a we place again,

Our comes Nachman next the from with question James. Gary line Raymond of

as on impressive. well My Very quarter. really congrats Yes. great a really,

So ADMAlytics time could initiatives then that given check. your just yield it's to now even you're incredible what of all really talked in should the conservatism, able thinking and I keeping be enhancements. Or increase it the about mean, back history over that your than higher as with max? you be the to XX% on leverage, expenses the And the program do, operating about? we

penetration sense consideration. enough invest marketing, wait before to if it if have and you with first question supply would begs it of than sales to that's a makes But Or more? less the in X%, to do still is more you ASCENIV spend the the have

that reminded I the with Skyler the Thank wrote that I for most first want by said saying them. me, call Gary, questions. you do down, us, were to when on I party. great start to welcome All but off your you

good I So time. have you a hope

to yield regard and conservative. -- enhancing But with

Okay.

So data. is about data. this. conservatism is not actual process with do think This scientific I This

takes shouldn't pretty team the there takes -- financial is counsel and I and some for our that going upside? what I approach saying and Grossman, and guidance, board to you're you take much get. apply This that room sure. Adam to advisers mean, my here. So Is that

is my they team at think what good I do. very

a some and drugs analysts both but and XX% be at that, as it's that think is are fair think think It's on their models, that may that very room, looking XX%. very, -- I investors I target. I appropriate and there

spend, this I Fair financial primary the have stigma are and guys? deficient immune It's XX% highly sales being with really the Gary. that XXX guidance, conservative financial in I there for U.S. although about should guess, population are say seeing marketing So is XX%. guidance. doctors It's that XXX, not

the and as We primary ambulatory well allocation IG. the successful about to know our base that specialty our private pharmacy, ability as to feel infusion really dealing the doctors use with who and involved on deeply continue geographic well incentive grow engaged PBMs capital customer efficient carry measures with practices that with. the as distribution We been to availability. large to we've the good are, the centers, education medical message supply so and and are very patients We where grow our immune-deficient as

with are working We're own appropriately you within And donors run to more. for third-party our So that up spending incentivize product. to that to very, are try high the network our yield couple with feeling RSV we enhancement side-by-side working tire demand frequently. very be center to current we to come collect able collection we're hard with to the more to suppliers catch

So hopefully answers your question. that

times is of here and we but we're that, some to growth. are do line we structured that's done have augmenting that. and grows, we're fall certain the way have structured have structured have that structure, for structure, we to just of through. I that in point, that more this it feel areas top Yes, we it's in beauty Do We'll and But the of going kind further augment our a the work few we we been will have a we to can continue and we leveraging that absolutely, our growth more to for mean to the said again, do grow. right? there,

good So we're like in feel a we place.

it's more run do, rewarding, that to going continue walls here, got here. it. Everybody my since fun a and best mean lots it's that work very through to Yes. make going We here. to continue shareholders. we're does about to the feel beginning. out I the walls our to always work, for run It's of We a patients. we We best love but people. we team places lean. there. have we really through And to it's Gary, run our I'll Gary. just lot hard that listening. helps know for you've but the staff say, what motivation, We're good We good product I

going we're successful team. be So to a working as

second That's for great. is just then more. first physicians helpful. using you still carefully, you ASCENIV that? PI you reasonable very all ASCENIV words are a of when that majority say have you I line that That contribute was time, a those patients more X/X, at can What's line And Do couple is expectation? plus. And as think considering co-morbid Or significant all respiratory conditions? over chose know a XX% but than

I ball That's I didn't these no things I tell hope. Gary. that mean I it's XXX%, have my hope me happening crystal all today. idea. what are

first-line PI, does co-morbid So I Adam described. just that I use should like patient. don't we're appropriate Grossman I patients think I'm not as say complex in just a just going use that or for believe after going the that PI you therapy. a to --

to we a CEOs things be on you to honest. I'm compromized ASCENIV. that, use. be there the appropriate patient appropriate patient every going right patient seen population of Not If lot is thing use. product like immune aren't on for The say haven't ASCENIV needs to who the are website, want not sure every but And needs

great I the impurity It's a product. said, got very, good on It's we've it's a Some drug. BIVIGAM, it's wonderful I as standard regular mean patients on well very the incentive. do made It's patients great way on a same really profile same got IG. drug.

co-morbid increased And where to all with and patients are space population. our IG to is the market excited. immune-compromised resonating I payers use that, Some very are There the defining are in pharmacoeconomic proposition in fact brethren respect is reporting The robust we're the severely and that's there, on appropriate and recognize successful. out refractive this we're it, growing we population, But thrive plenty ASCENIV of be value that well. going companies utilization. think patients more

product products differentiated -- that the unique do got very and way a truly We're proud we've our we that we ASCENIV. and make with

we're it who patients doctors have and easier is a bit as come patient with tried that who to therapy. line using alternative it this third an fail, when ASCENIV, makes for payer those So second, IV switch if subcu, product you've can work increase or they got offering brands, to a fourth the dose, little a everything

This concludes the it would question-and-answer Grossman . I like now session. for closing Adam back to turn remarks. to

None just all I So want this possible is the without thank you. of ADMA to team. of

work. doing You're great

You're impacting improving lives. changing,

stockholders, everyone out make of do Let's pleased to else there products we're people. continue up going all to other keep it to that our what help do, We and to investors constituents. good hope you're we

continued and your for you thank next So see we'll support, you quarter.

Thank you This for your participation in today's conference. does conclude program. the

may disconnect. now You